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GUAM
FOOD CODE
REGULATIONS GOVERNING SAFE FOOD HANDLING AND THE SANITARY
OPERATION OF RETAIL FOOD ESTABLISHMENTS
_______________________________________________________________________
REGULATIONS GOVERNING SAFE
FOOD HANDLING AND THE SANITARY
OPERATION OF FOOD
ESTABLISHMENTS TO PREVENT
FOODBORNE ILLNESS
_______________________________________________________________________
DEPARTMENT OF PUBLIC HEALTH AND SOCIAL SERVICES
DIVISION OF ENVIRONMENTAL HEALTH
123 CHALAN KARETA
MANGILAO, GUAM 96913-6403
Title 5 Guam Code Annotated, Chapter 9, Article 3
ECONOMIC IMPACT STATEMENT
GUAM FOOD CODE
SUMMARY
The Department of Public Health and Social Services (DPHSS) is proposing to adopt the Guam
Food Code to replace the existing “Rules and Regulations Relative to Eating and Drinking
Establishments” and apply this document for the regulation of all retail food facilities on Guam.
Retail food facilities (RFF) are those commercial establishments which prepare and provide
packaged and non-packaged foods directly to consumers; it does not include food manufacturers
and distributors.
DPHSS issues approximately 3,000 Sanitary Permits annually to various health-regulated
establishments, and just over half are for retail food facilities. In Fiscal Year 2011, 1,092 and
561 Sanitary Permits were issued to RFFs in the categories of Eating and Drinking
Establishments and Food Establishments, respectively, for a total of 1,653 permits. If adopted,
the Guam Food Code will govern the sanitary operation of these 1,653 facilities and the
compliance inspections conducted by the Division of Environmental Health (DEH) of DPHSS.
Because the total financial impact is expected to exceed $500,000, this economic impact
statement was prepared by DEH, pursuant to Article 3 of Title 5 GCA Chapter 9, using available
local and national data and the collection of survey data from sampled establishments. A survey
questionnaire was distributed to over 300 establishments that would be affected by the adoption
of the Guam Food Code; one-hundred responses were received. The survey focused on four
specific requirements of the code that DEH believes would have the biggest financial impact to
the regulated facilities. These four provisions were the no bare-hands contact; consumer
advisory; manager certification; and the reduced cold holding temperature requirements. DPHSS
also reviewed the local morbidity reports of the past decade and national statistics on food-borne
illnesses.
As a result of the survey, it is estimated that the adoption of the Guam Food Code will have a
direct total financial impact of $1,888,914.80 to the industry and DEH in the first year of its
implementation. In subsequent years, the financial cost will be reduced to about $1,142,943.30 a
year as the one-time costs for the replacement of the refrigeration units and the training of
industry by DEH will no longer be applicable.

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No bare-hands contact (Projected annual cost: $482,308.80)
Consumer advisory (Projected annual cost: $478,804.50)
Manager certification (Projected annual cost: $181,830)
Reduced cold holding temperature (Projected one-time cost: $719,051.50)
Training workshops (Projected one-time cost: *$26,920)
*$6,000 incurred by DPHSS for securing training venue sites
Economic Impact Statement (Final 04.03.13)
Guam Food Code
Division of Environmental Health, DPHSS
The anticipated costs given by the respondents in the survey were liberally interpreted by
calculating the upper ends of their estimates. The projected one-time cost of $719,051.50 that
may result from the implementation of the reduced cold-holding temperature provision of the
code may actually be much less than reported by the survey respondents based on the
observations of DEH personnel during inspections of these facilities and the findings of the State
of North Carolina in their own economic impact study for their adoption of the FDA Food Code.
The economic impact to the industry is nominal ($3.07/day for the first year and $1.86/day the
following years) if the costs are equally distributed to all the affected retail food facilities. Thus,
it is unlikely the increased cost from implementing the Guam Food Code will be passed down to
the employees or customers, or result in any substantial increase in the cost of business. Adverse
impact to employment is also not expected. Instead, there may be an increase in employment as
establishments may need to recruit a certified manager or additional certified managers to ensure
one is on duty during the entire operation of the their establishments
While the increased costs that will result from the adoption of the Guam Food Code may be
deemed as an adverse impact to the affected businesses, the overall impact will be beneficial to
the economy and the health of the population from the expected reduction in the number of
foodborne illness incidents on the island and its associated economic burden. The collective
reduction of the economic burden derived from food-borne illness through the implementation of
preventive measures mandated in the Guam Food Code will outweigh the actual and imagined
cost that the industry will experience in the adoption of the code.
From the period of 2002-2011, there were 1,584 diseases reported in Guam that were of types
associated with the consumption of contaminated food or water. The largest food-borne illness
outbreak ever recorded on Guam in the past 20 years occurred in May 2011; it involved over 350
elementary school students in five public schools, and was linked to a regulated commercial food
facility. The island also averages over 1,000 gastroenteritis cases a year, and if 20% of the
infections are caused by the norovirus, as reported by U.S. Centers for Disease Control and
Prevention, then it may be assumed that about 200 of the island’s reported incidents are due to
the virus. Norovirus infections account for nearly 60% of all known foodborne illnesses in the
U.S.
The economic burden of food-borne diseases in the U.S. annually has been estimated to be $77.7
billion resulting from the 48 million food-borne illnesses occurring every year in America. This
equates to $1,626 per case. If the annual estimate is applied to Guam using the island’s 2010
census, Guam’s share of the economic cost for food-borne illnesses would be approximately
$41.3 million a year. The May 2011 outbreak at the five public schools is estimated to have had
an economic burden of $257,150 from the health impact alone, and does not include the cost
incurred by the government in responding to the outbreak. While the implementation of the
Guam Food Code will not assure that all food-borne illnesses will be prevented on Guam, and
thus eliminating the estimated $41.3 million economic burden, it will however reduce the
potential for this type of illnesses from occurring. If the Guam Food Code can prevent even a
single case of listeriosis on island, which has an economic burden that is estimated to be over $1
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Guam Food Code
Division of Environmental Health, DPHSS
million a case, through the lowering of the cold holding temperature provision, then the code can
theoretically offset much of the economic impact to Guam’s retail food facilities.
I. Purpose and Need
The lawful operation of businesses regulated by the Department of Public Health and Social
Services (DPHSS) requires the acquisition of a Sanitary Permit from the Division of
Environmental Health (DEH) of the Department pursuant to Title 10 GCA Chapter 21. The
issuance of a Sanitary Permit enables DEH to regulate the applicable establishments to ensure
that these facilities are sanitary and operate in such a manner as to prevent the transmission of
communicable diseases, which include food-borne illness, to the public. Businesses possessing a
Sanitary Permit are required to allow the access and inspection of its regulated facility by DEH.
One type of regulated business is the retail food facility (RFF), which provides food directly to
consumers. RFF includes restaurants, bars, stall stands, caterers, cafeterias, grocery stores,
mobile food carts, and other similar permanent and temporary establishments, but does not
include wholesalers/distributors which do not provide food directly to consumers.
DEH conducts compliance inspections of RFF to ensure these establishments operate in a
manner, and possess the physical assets, to prevent food-borne illness in those who consume
their food products. These regulatory inspections are conducted through the implementation of
adopted rules and regulations that provide the sanitary operation and physical requirements that
RFF must comply with, such as:










Construction and maintenance of the establishment
Preparation, display, transportation, storage, and protection of food
Health, personal cleanliness, clothing, and practices of food employees
Equipment installation and usage
Cleaning and sanitization of equipment and utensils
Water supply and plumbing of the establishment
Hand-washing and toilet facilities
Waste removal
Insect and rodent control
Lighting and ventilation of the establishment
Currently, DEH imposes the “Rules and Regulations Relative to Eating and Drinking
Establishments” and the “Rules and Regulations Relative to Retail Food Store Sanitation” for
the regulatory control of all RFFs on Guam. The two regulatory documents were adopted in the
years 1984 and 1987, respectively. Since the adoptions of the two regulations, over twenty years
ago, there has been increased knowledge about food pathogens and improvements in the
technology and practice of food safety. To incorporate and apply the new information and
improved practices for the purpose of better protecting the public from food-borne diseases that
could occur from consuming commercially available food products and meals, DEH seeks to
update its existing rules and regulations by adopting the “Guam Food Code,” which closely
mirrors the Model Food Code that was developed by the U.S. Food and Drug Administration
(FDA). The Model Food Code is a science-based guide for food protection that FDA encourages
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Economic Impact Statement (Final 04.03.13)
Guam Food Code
Division of Environmental Health, DPHSS
all U.S. jurisdictions to adopt for uniformity. The document guide is reviewed every 2 years.
Many states have adopted the model code in parts or in whole.
According to the U.S. Centers for Disease Control and Prevention (CDC), it is estimated that
there are 48 million food-borne illnesses in the U.S. annually with 128,000 hospitalizations and
about 3,000 deaths1. Norovirus accounts for the most food-borne illness (58%) in the U.S. for all
known pathogens. It is also one of the leading food-borne pathogens that cause hospitalizations.
The five known food-borne pathogens that cause the most deaths in the nation are Salmonella,
Toxoplasma, Listeria, norovirus, and Campylobacter. Collectively, they contribute to 88% of all
food-borne illness deaths.
From 2002 to 2011, Guam had 698 reported cases that were identified as “food poisoning” over
the ten year period2. If other reported diseases, which can be acquired through the ingestion of
contaminated food, water, or other vehicles, were included (i.e., cholera, Hepatitis A, Vibrio,
etc.), this number would be 1,584 over the same period. These figures exclude the number of
reported “gastroenteritis” cases, which averaged 1,093 a year (or 10,093 total cases) for the ten
year time span3. In a March 21, 2013 press release, CDC reported that norovirus is now the
leading cause of severe gastroenteritis in U.S. children4. The press release noted that 21% of the
total acute gastroenteritis cases they examined were caused by norovirus.
The true number of food-borne illnesses recorded on Guam is likely much greater since most go
unreported. Regardless of the actual number of incidents that may occur on Guam, food-borne
illness is a significant public health concern and a single outbreak can include hundreds of
individuals, such as the one that sickened over 350 students at five public schools in May 2011.
It was the largest recorded food-borne illness outbreak on Guam in the last twenty years. Two
more separate outbreaks involving more than 20 individuals each also occurred in 2011.
With the adoption of the Guam Food Code, the Department of Public Health and Social Services
seeks to prevent and reduce the number of food-borne diseases occurring on island. Two
specific provisions - reduced cold-holding temperature and no bare-hands contact - in the
proposed code will place additional safeguards to protect the public from listeriosis and
norovirus, respectively. The Guam Food Code will also ensure that managers of all RFFs
become certified as possessing food safety knowledge and its application.
II. Financial Impact
The Department of Public Health and Social Services (DPHSS) issues approximately 3,000
Sanitary Permits annually to various regulated businesses on Guam. Of the total number of
permits issued, nearly 75% are for food-related facilities, and of that, approximately threefourths are retail food facilities (RFF). Therefore, over 1,600 permitted establishments would be
governed, and thus impacted, by the adoption of the Guam Food Code.
The Guam Food Code (the “Code”) essentially has the same requirements as the existing rules
and regulations, but is much more detailed and comprehensive. More importantly, it also places
additional safeguards, thus, further requirements on the industry, to protect consumers from
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Economic Impact Statement (Final 04.03.13)
Guam Food Code
Division of Environmental Health, DPHSS
potential food-borne diseases. The most significant changes that would likely have the greatest
financial impact to the RFF are the no bare-hand contact provision; reduction in cold-holding
temperature; implementation of the consumer advisory; and the requirement of a managerial
certification of all RFF managers on duty:
a. The Guam Food Code will prohibit the use of bare hands when handling ready-to-eat
foods to reduce the likelihood of illnesses caused by those pathogens that have high
infectivity and are associated with poor hygiene, such as norovirus and shigella. As a
result, ready-to-eat meals cannot be touched with bare hands.
Consequently,
establishments will need to implement practices that may result in additional costs, such
as procurement of (disposable) gloves and additional utensils.
b. The Code will lower the cold-holding temperature from 45 °F to 41 °F to control the
growth of the pathogenic bacteria, Listeria monocytogenes, which can grow at
temperatures lower than most pathogenic bacteria. To meet the new requirement, some
establishments may need to retrofit, repair, or replace their refrigeration unit(s) so that it
may keep food at lower temperatures than currently required. Such correction or change
will cause the affected facilities to incur additional costs with the biggest financial impact
to those possessing larger refrigeration units, such as the walk-in chillers.
c. Consumer advisory is a provision in the Guam Food Code that requires retail food
establishments to inform their customers of the increased risk from pathogens if the
establishment serves or sells raw or undercooked beef, egg, pork, fish, lamb, milk,
poultry, or shellfish in a ready-to-eat form or as an ingredient of a food item in ready-toeat form. Such notification must be in writing through brochures, label statements, menu
advisory, placards, or other effective written manner. The cost of compliance will most
likely derive from the printing of the notices or stickers and the manpower to place these
notices on pre-packaged, retail products.
d. The proposed Code will require the person-in-charge to be present during all hours of
operation of the RFF, and that the person-in-charge is a “certified food protection
manager” who has passed a food protection manager certification program. The Code
will be placing greater responsibilities on the manager of the RFF for its sanitary
operation and the food it provides. The certified manager may be orally quizzed on
his/her food safety knowledge by DEH staff during compliance inspections. The
certification will require the manager to attend a brief course and pass its written
examination. The cost of the certification course will be borne by the attendees, while
the RFF may incur additional expenses from having its manager away from the worksite
to attend the course.
To assess the direct financial impact the Guam Food Code may have on the 1,653 retail food
facilities on island as a result of the adoption and implementation of the four specific provisions
noted above, DPHSS conducted a survey. This survey, which was prepared in the form of a
questionnaire (Attachment A), asked the following eleven questions of 312 randomly selected
RFFs currently possessing a Sanitary Permit with the Department:
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Guam Food Code
Division of Environmental Health, DPHSS
Part I: Consumer Advisory
1.
Does your establishment serve or sell ready-to-eat undercooked meat, seafood, and
poultry products?
2. If “YES” and the Guam Food Code is adopted, how do you plan to advise your
customers?
3. What is the anticipated cost your business will incur in developing and providing the
written advisory to your customers?
Part II: Manager’s Certificate
4.
What are your hours of operation at this location?
5.
How many shifts do you have during these hours?
6.
How many of your shift supervisors have a current Manager’s Certificate?
Part III: Cold Holding
7.
Does your facility have existing refrigeration equipment that is capable of maintaining
food at 41 ºF or less?
8.
If “No,” how many refrigeration units will you need to purchase to be sufficient in
number and capacity for your operation?
9.
What is the total cost your business will likely incur to purchase new refrigeration
equipment that is capable of maintaining food at 41 ºF?
Part IV: No Bare-Hands Contact
10. Do your employees use their bare hands when handling ready-to-eat foods?
11. What is the total monthly cost your business has incurred, or will likely incur, to
implement the “no-bare hands” provision, including anticipated expenses to purchase
items checked in #2 above and any other associated costs.
The methodology of the survey and the determination of the sampling size of 312 establishments
from a total of 1,653 RFFs are provided in Attachment B. Anticipating no response from some
of 312 sampled establishments, DPHSS distributed the questionnaire to an additional 88 other
randomly selected establishments for a total of 400 surveys.
In the two weeks given to the establishments to submit their completed survey, DPHSS received
100 responses. Not all of the respondents answered every question or followed the instructions
given. Because the number of responses received was well below the determined sampling size
of 312, the results are not statistically reliable. However, the findings did provide insight into the
possible financial impact the implementation of the proposed Guam Food Code would have on
the retail food establishments. Graphical results of the survey are provided in Attachment C.
Consumer Advisory
 Seventy respondents (70%) indicated that their facility did not serve or sell readyto-eat raw or undercooked meat, seafood, and poultry products. Two respondents
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Division of Environmental Health, DPHSS
did not answer the question, which suggested they too did not serve or sell these
types of item.
 Twenty-eight respondents (28%) that noted that their facilities did serve or sell
ready-to-eat raw or undercooked meat, seafood, and poultry products revealed
that the written advisory would be provided by the following means (Note:
Several respondents checked multiple answers):
o Menu: 13
o Placard: 7
o Label: 23
o Brochure: 4
o Other: 5
 When asked what is the anticipated cost their business may incur to provide the
written advisory to their customers, most (19 respondents – 57.6%) selected the
cost-range of $0.00 - $499, which was followed by $500 - $999 (7 respondents –
21.2%). Around 9.1% (3 respondents) indicated that the impact would be from
$1,000 to $1,499. Four respondents (12.1%) noted that their anticipated cost
would be $1,500 or greater. Twenty-eight responses were expected for this
question since that was the number of respondents who had indicated that they
would need to provide written consumer advisory; however, thirty-three had
actually responded to this question about the anticipated cost.
Based on the results of the survey, most retail food facilities do not serve or sell raw
or undercooked ready-to-eat meat, seafood, or poultry products; thus, the majority
would not be impacted by this particular provision. For those facilities affected, just
over half would not expect to expend more than $500 to effectuate the provision, but
because it was not made clear in the questionnaire, it is unknown if such cost is a
monthly, yearly, or other date-related expense, or if this is a one-time cost. For those
facilities needing, or wanting, to place its advisory on labels for their raw or
undercooked RTE foods, such as grocery stores, the expenses will very likely be a
recurring event.
Assuming that the reported, anticipated cost is a yearly expense and reflects the entire
RFF population, the direct annual impact of the Consumer Advisory requirement to
these facilities will be approximately $478,804 if the upper end of each cost range
was used for the assessment, as determined from the survey (Table 1).
Cost Range
$0.00 - $499
$500 - $999
$1,000 - $1,499
$1,500 and over
TOTAL
Respondents
19 = (19/100) = 19%
7 = (7/100) = 7%
3 = (3/100) = 3%
4 = (4/100) = 4%
33%
Number of RFF
19% x 1,653 = 314.1
7% x 1,653 = 115.7
3% x 1,653 = 49.6
4% x 1,653 = 66.1
545.9
Financial Impact
$499 x 314.1 = $156,735.90
$999 x 115.7 = $115,584.30
$1,499 x 49.6 = $74,350.40
$1,999 x 66.1 = $132,133.90
$478,804.50
Table 1. Estimated financial impact to Guam’s Retail Food Facilities (RFF) to implement the consumer advisory provision of the proposed
Guam Food Code.
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Economic Impact Statement (Final 04.03.13)
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Division of Environmental Health, DPHSS
Manager’s Certificate
 While some RFFs operate 3 hours a day, others remain open 24 hours, but on the
average, the facilities operate 12 hours a day. Five respondents had failed to
respond to the question.
 Between 35 - 48% of RFFs have two shifts in their operation, while 16% to 21%
had only one shift. Eleven did not provide a response.
 Nineteen to twenty percent (19% - 20%) of the RFFs have one or two shift
supervisors possessing a manager’s certification of some kind. No response was
received for this question from forty-six respondents.
The daily 12-hour operation of many RFFs was consistent with what’s commonly
observed in the food industry (open at 10:00 a.m. and close at 10:00 p.m.), which
reflected the existence of two work shifts for several of the RFFs. Because over 70%
of the respondents indicated the presence of 1 or 2 supervisors with a manager’s
certificate, it appears most RFFs have at least one certified manager on duty during
half or full day of their operation. However, lack of response to the question by 46%
of the participants may also suggest that nearly half of the RFFs operate without the
presence of any certified manager.
Current DPHSS rules and regulations require food facilities with 5 or more
employees to have present at all time when operating, a manager with a Manager’s
Certificate from the Guam Community College (GCC). This particular certification
is valid for 3 years. With the implementation of the Guam Food Code, all RFFs,
regardless of the number of employees, will require that a certified manager be
present when in operation. Assuming that all 1,653 RFFs on island will need a
certified manager, and each have two shifts, there will be a need for 3,306 certified
managers, but since about half have at least one manager who is currently certified, it
is expected that about 1,653 managers will require certification. With GCC assessing
a fee of $110 per applicant for the certified manager course, DPHSS anticipates that
the cost impact to the industry for this provision will be $181,940 in the first year:
o 1,653 total RFFs have two shifts on the average and each shift requires
a certified manager:
 1,653 x 2 = 3,306 Certified Managers needed
o Nearly 50% of all RFFs have at least one certified manager
 3,306 ÷ 2 = 1,653 RFFs with one certified manager
o Remaining managers without certification
 1,653 x $110 per applicant = $181,830
 $181,830 = Anticipated impact cost to RFFs
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Economic Impact Statement (Final 04.03.13)
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Cold Holding
 Eighty-one respondents (81%) revealed that their refrigeration unit(s) had the
capability to maintain food at 41°F or less. Twelve percent (12%) did not answer
this question. Seven percent (7%) responded that their refrigeration units were
not able to hold food at 41°F or less.
 Half of the respondents (4 out of 8) to the question that had asked the number of
refrigeration unit(s) they will need to purchase to comply with the proposed
requirement replied that 1 unit will bought. (Note: Although 7 responded that
their units would not meet the new cold holding requirement, 8 answered the
question on the number of units that will need to be purchased.)
 One responded that as many as four 4 units would need to be purchased to meet
the new requirement.
 Sixteen (16), instead of the expected 7, responded to the question about the
anticipated cost to replace their refrigeration units.
o 4 respondents indicated that the costs would be $5,000 or greater;
however, three of them had not indicated that they would need to
replace any refrigeration units in the previous question
 The lone respondent who did answer the need to replace his/her
refrigeration unit indicated that 2 units would need to be
purchased
o Three (3) indicated that the costs would be $1.00 to $499
 Two of the three noted that they would need to replace 1 and 2
refrigeration units, while the third did not indicate such need
o Remaining 9 respondents noted that their anticipated costs to replace 1
to 6 refrigeration units would be between $500 to $4,999
The majority of the respondents had indicated that their refrigeration units did have
the capability to cool their food products to the proposed cold holding temperature of
41 °F or lower; this was not unexpected. It has been the observation of DPHSS’
compliance officers that most, if not all, of the RFFs that have been inspected possess
refrigeration units that are able to meet the new requirement, and those facilities that
couldn’t were utilizing equipment that were damaged or improperly maintained.
Furthermore, not all RFFs would require refrigeration of their food products since
they may carry only non-perishable foods (i.e., dry and canned goods), as suggested
by the lack of response by 12% of the respondents to this particular question.
Refrigeration units observed in the island RFFs have ranged from a small tabletop
refrigerator or reach-in chiller to the large industrial-grade walk-in chiller. Thus, the
cost differences between one unit and another can be extremely wide and varied,
which may explain the broad distribution of responses in the question about the
anticipated cost to comply with this provision in the survey.
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Economic Impact Statement (Final 04.03.13)
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In determining the projected direct economic impact the RFFs will sustain in the
implementation of this provision, the highest end of each price range (Question 3 of
Part III) was multiplied by the number of affected RFFs, which was determined by
the number of respondents for each range and its corresponding percentage to the
total number of RFFs. For responses of “$5,000 and above,” the lower end of the
range was used in the calculation. As a result, it is estimated that the cost would be
$719,051.50 based on the survey responses (Table 2).
Cost Range
$1.00 - $499
$500 - $999
$1,000 - $1,499
$1,500 - $1,999
$2,000 - $2,999
$3,000 - $4,999
$5,000 and over
TOTAL
Respondents
3 = (3/100) = 3%
2 = (2/100) = 2%
2 = (2/100) = 2%
2 = (2/100) = 2%
1 = (1/100) = 1%
2 = (2/100) = 2%
4 = (4/100) = 4%
16%
Number of RFF
3% x 1,653 = 49.6
2% x 1,653 = 33.1
2% x 1,653 = 33.1
2% x 1,653 = 33.1
1% x 1,653 = 16.5
2% x 1,653 = 33.1
4% x 1,653 = 66.1
264.7
Financial Impact
$499 x 49.6 = $24,750.40
$999 x 33.1 = $33,066.90
$1,499 x 33.1 = $49,616.90
$1,999 x 33.1 = $66,166.90
$2,999 x 16.5 = $49,483.50
$4,999 x 33.1 = $165,466.90
$5,000 x 66.1 = $330,500
$719,051.50
Table 2. Estimated financial impact to Guam’s Retail Food Facilities (RFF) to implement the reduced hold holding temperature provision of the
proposed Guam Food Code.
No Bare-Hands Contact
 Seventy-nine percent (79%) of those responding to the survey indicated that they
did not use bare hands when handling ready-to-eat foods, while 14%
acknowledged using bare hands. Seven respondents did not provide a response to
this question.
 For those not using bare hands when handling ready-to-eat meals, most used
either single-use gloves or utensils.
 More than half indicated that the cost to implement the no bare-hands practice is,
or expected to be, less than $200 a month.
The direct financial impact that will be borne by the RFFs for implementing the no
bare-hands contact provision will derive from the purchase of disposable gloves
and/or additional utensils. The indirect cost associated with no bare-hands contact
may occur through the expenditure of non-monetary resources (i.e., time and effort)
by the RFFs seeking and receiving waivers from this requirement.
Such
establishments, which will likely include manufacturers and dining facilities that
provide/serve sushi, will be required to implement alternate safeguards and the
Hazard Analysis Critical Control Point (HACCP) that will require additional time and
effort by the RFF.
Using the results of the survey, it is assumed that 14% of all RFFs (232) will need to
begin implementing the no bare-hands requirement upon the adoption of the Guam
Food Code. Further assuming that these affected 14% will be incurring costs for the
purchase of disposable gloves and/or utensils at the same costs as the survey results,
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the direct monetary effect to the island’s RFFs will be about $38,266.80 per month.
This equates to $482,308.80 a year (Table 3).
Cost Range
$1 - $49
$50 - $99
$100 - $199
$200 - $399
$400 - $599
$600 - Up
TOTAL
Respondents
Number of RFF
19 = (19/100) = 19%
19% *[(14%)*(1,653)] = 43.9
19 = (19/100) = 19%
19% *[(14%)*(1,653)] = 43.9
13 = (13/100) = 13%
13% *[(14%)*(1,653)] = 30.1
12 = (12/100) = 12%
12% *[(14%)*(1,653)] = 27.8
03 = (03/100) = 3%
3% *[(14%)*(1,653)] = 6.9
09 = (09/100) = 9%
9% *[(14%)*(1,653)] = 20.8
75%
173.4
$40,192.40 x 12 months = $482,308.80/year
Financial Impact
$49 x 43.9 = $2,151.10
$99 x 43.9 = $4,346.10
$199 x 30.1 = $5,989.90
$399 x 27.8 = $11,092.20
$599 x 6.9 = $4,133.10
$600 x 20.8 = $12,480.00
$40,192.40
Table 3. Estimated financial impact to Guam’s Retail Food Facilities (RFF) to implement the no bare-hands contact provision of the proposed
Guam Food Code.
DPHSS Training
The financial impact to the Division of Environmental Health was also evaluated based
on the multiple workshops the Division is expected to provide to the RFFs to orient and
educate the industry on the Guam Food Code. Consequently, the monetary impact to the
industry to participate in these workshops was also examined.
In September of 2011, DEH provided three separate training sessions to over 200
industry representatives on the provisions of the 2005 Model Food Code in preparation
for the adoption of the Guam Food Code. All RFFs with Sanitary Permits with the
Division were invited, and while not all took advantage of the free course most did
attend. The Division anticipates that the same type of workshops will need to be
provided once again upon the adoption of the Guam Food Code. In calculating the
projected cost to provide these training workshops, DEH examined the resources that
were expended in 2011 and determined that the cost to provide the same would be $6,000
for the rental of the venue sites to nearly 250 industry representatives:




Number of expected industry participants:
Number of full-day (8 hours) training sessions:
Venue cost to accommodate 50 participants:
Total cost:
250
5
$1,200
5 x 1,200/50pax = $6,000
The total financial impact is applicable to only the first year of the Code’s
implementation. Further training of RFF representatives will occur through the required
certification of managers who oversee the operation of their RFFs. The personnel cost
incurred by DEH to provide the training workshops was not determined since such
activity is part of the Division’s mission and responsibilities.
Note: The 1,653 permitted RFFs will not reflect the total number of individuals that
DEH is expecting to train because: some attendees will be representing multiple RFFs
since their respective business owns/operates one or more facilities; many RFFs are
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Guam Food Code
Division of Environmental Health, DPHSS
temporary establishments without permanent representatives; and some will not be
taking advantage of the opportunity for whatever reason.
According to the U.S. Department of Labor, Bureau of Labor Statistics, the average wage
of first-line supervisors in food preparation facilities, who are the probable participants of
the training workshops, is $10.46 per hour5. Thus, the total financial impact to the
industry of attending the training presented by DEH will be approximately $20,920:





Number of hours attending the training:
Number of participants:
Total hours attending the training:
Average wage of attendee:
Total cost:
8 hrs
250
8 hrs. x 250 = 2,000 hours
$10.46/hr
$10.46/hr x 2,000 hours = $20,920
Summing the projected costs of DEH providing the training and the industry
representatives attending the workshops, the total cost will be about $26,920.
Total Financial Impact
Among the four provisions of the proposed Guam Food Code evaluated in the survey, reduced
cold-holding temperature requirement appears likely to have the greatest financial impact to the
retail food facilities as 7% - 8% of all RFFs will need to purchase one or more refrigeration units
at the total estimated cost of nearly $720,000 to meet the proposed new requirement. Consumer
advisory is expected to cost 463 RFFs almost $480,000. This was followed by the annual cost of
about $482,000 by 232 RFFs to comply with the no bare-hands contact provision. The
manager’s certification requirement will have the least monetary impact to the RFFs at $181,830.
The following year and thereafter, the amount will be reduced as the cost of the refrigeration
units will no longer be applicable. Because these estimates are based on the results of the survey
questionnaire, which did not represent the ideal sample number of the population, the data should
be viewed only as an approximation.
The monetary impact to the Division of Environmental Health of DPHSS will occur through the
training workshops the Division will be providing to the industry representatives to orient and
train them in the Guam Food Code. The cost of hosting the five separate 8-hour workshops at a
rented venue for 250 attendees by DEH personal, who will be providing the training, will have a
financial impact of $6,000. For industry representatives to attend these workshops, they will
experience an additional total cost of $20,920. Thus, the total cost to present and attend the
training workshops will have a one-time economic impact of $26,920.
The grand total of the direct financial impact to the island for the adoption and implementation of
the Guam Food Code is determined to be $1,888,914.80 in the first year and $1,142,943.30 in
subsequent years (Table 4).
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Guam Food Code
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Total Direct Cost of Adopting the Guam Food Code
Requirement
Anticipated Cost
Consumer Advisory
*$478,804.50
Manager’s Certificate
$181,830.00
Cold Holding
**$719,051.50
No Bare-hands Contact
$482,308.80
Training Workshops
**$26,920
Comments
Requires retail food establishments to
inform their customers of the increased
risk from pathogens when consuming
certain raw or undercooked foods
Person-in-Charge of a retail food
establishment will be required to possess
certification of his/her knowledge of
food safety
Cold holding temperature will be
reduced from 45 °F to 41 °F to control
the growth of the pathogenic bacteria,
Listeria monocytogenes
Prohibits the use of bare hands when
handling ready-to-eat foods to reduce the
likelihood of illnesses caused by those
pathogens that have high infectivity and
are associated with poor hygiene
DEH-DPHSS to provide five separate 8hr training workshops to industry
representatives on the Guam Food Code
ANTICIPATED TOTAL DIRECT COST IN THE FIRST YEAR = $1,888,914.80
ANTICIPATED TOTAL DIRECT COST IN SUBSEQUENT YEARS = $1,142,943.30
Table 4. Financial impact of adopting the proposed Guam Food Code based on the cost analyses of implementing the four significant
requirements that would likely have the greatest economic impact to the industry and the training workshops that the Department of Public Health
and Social Services will be providing to the industry on the new requirements. *The higher end of the cost range was utilized for the calculation.
**One-time cost impact to RFFs and DPHSS.
Financial Impact: Guam Food Code vs. North Carolina Food Code
For comparative purposes, the survey results were measured against the fiscal impact evaluation
conducted by the State of North Carolina in their adoption of the 2009 FDA Food Code6.
Although there were several changes made to the 2005 FDA Food Code (that the Guam Food
Code was mirrored after) in the development of the 2009 version, which North Carolina adopted,
these changes were mostly enhancements to improve the language and the code’s designation
system. Thus, the changes were not overly significant and the two versions are quite similar,
including the four provisions of the Guam Food Code that were surveyed by DPHSS.
North Carolina also examined the economic impact the consumer advisory, reduced cold-holding
temperature, managerial certification, and the prohibition of bare hands would have on its food
industry. The state also conducted an industry survey similar to DPHSS but through an online
service. Of the 1,642 operators identified for the survey, North Carolina was able to get a
completed response from 277, which represented 0.9% of the total ~31,000 food establishments
in the state. DPHSS’ survey response was much higher with 6.0% of the total RFFs.
In their findings, North Carolina concluded that total cost to the industry for requiring their
managers to become certified would be $4,496,000 (Guam = $181,830). This figure was
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applicable to all the persons-in-charge of their RFFs at an average cost of $125 per person. This
came out to be about $145 per establishment ($4,496,000/31,000). For Guam, the cost would be
less at $110 per RFF.
For preventing the contamination of ready-to-eat meals by hands (aka, No Bare-hands Contact),
North Carolina identified the monetary impact to the industry as “unquantifiable” since the
requirement can be readily addressed through the use of “deli tissue, spatulas, tongs, single-use
gloves, or dispensing equipment,” but they acknowledged that the use of gloves may be the only
associated cost. In the state’s industry survey, 78% of their respondents did not allow the use of
bare-hands, which was nearly identical to Guam’s survey results (79%). Guam’s survey was
able to elicit the estimated impact cost to implement this provision from the responders.
In North Carolina’s economic impact report, the reduction of the cold-holding temperature from
45 °F to 41 °F was originally believed to cause a notable economic burden on the food service
industry as many would need to purchase new equipment since older refrigeration units would be
unable to meet the new requirement. However, their research had proven that only on rare
circumstances will the purchase of new refrigeration be necessary. The state’s report noted that
according to the National Sanitation Foundation (NSF), “most refrigerated storage units have
been designed to achieve a 40 °F holding temperature since 1966.” Furthermore, in response to
the development of the Model Food Code, NSF revised its standard in 1997 to conform to the
code, thus any refrigeration equipment replaced since 1999 should meet the 41 °F standard. The
report further concluded that an average life expectancy of reach-in units is 10-12 years while the
larger walk-in chillers had a longer life expectancy. In determining the one-time expected cost to
the industry, North Carolina made an assumption that 1% of their establishments (310) will be
required to replace 1 unit for the total cost $855,600.
In the DPHSS’ industry survey, 16% of the respondents indicated that they would need to
replace their refrigeration unit(s). The large difference between North Carolina’s assumption
(1%) and Guam’s survey results (16%) may suggest that many RFFs on island may possess
refrigeration units that are: older, improperly working, inadequately sized, or a combination of
the three. Furthermore, Guam’s tropical climate may be adversely affecting the units’ ability
maintain the lower temperature. If the total economic burden resulting from this requirement
was to be evenly distributed to its respective RFF population in North Carolina, each of the
state’s establishments would endure a financial impact of $28 ($855,600 ÷ 31,000), while each
RFF on Guam would sustain an impact of $435 ($719,051.50 ÷ 1,653). The substantial
difference of over $400 per each Guam RFF may further suggest that the respondents overestimated the cost impact in Guam’s survey, and thus, the economic impact of lowering the cold
holding temperature may actually be considerably less.
North Carolina deemed the economic impact in applying the consumer advisory provision to
their food industry as “unquantifiable.” Guam expects this provision will have a direct economic
impact to the local RFFs through the printing of the advisories.
The approximate cost determined by North Carolina for training the industry on their Food Code
was $471,400. Their analysis was based on the estimated time and cost incurred by their State’s
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Guam Food Code
Division of Environmental Health, DPHSS
food establishment supervisors for the extra one-hour spent with a compliance officer in a
“one-on-one training” during the establishment’s initial compliance inspections after the code’s
adoption. Guam’s analysis was based on the eight hours spent by each food establishment
supervisor attending the training workshop. While North Carolina estimated the cost impact to
its state and local governments for the enforcement of their code, DPHSS did not calculate such
cost as the training and the implementation of the Guam Food Code are deemed part of DEH’s
regular duties and responsibilities in training the community on food safety.
North Carolina had conducted additional cost analyses, which included other provisions of their
code. Nearly all were found to be either at “no cost”, “little to no cost”, or “unquantifiable cost”
to the industry.
Economic Burden of Foodborne Diseases
In the U.S., the annual economic burden of food-borne diseases is calculated to be $77.7 billion
based on the U.S. CDC estimates of 48 million food-borne illnesses occurring every year in
America7. This equates to $1,618.75 per case. A case of Norovirus has been calculated to be
$673 per case and $3.7 billion in total cost per year. Vibrio vulnificus had the highest per case
cost at $1.28 million, while Salmonella (nontyphoidal) had the greatest total cost at a staggering
$11 million a year. This study used economic estimates to include “pain, suffering, and
functional disability measure based on monetized quality-adjusted life year estimates.”
However, it did not include costs of local, state, and county health departments’ response to
food-borne outbreak response, thus, the actual economic cost amount is actually greater. If
Scharff’s annual estimate was applied to Guam using the island’s 2010 census, Guam’s share of
the economic cost for food-borne illnesses would be approximately $41.3 million a year.
A single case of listeriosis, an infection caused by the Listeria monocytogenes bacteria, which
can cause miscarriage, premature delivery, serious infection of the newborn, or even stillbirth,
has an estimated economic burden of $1.2 million a case. To retard the growth of Listeria, the
proposed Guam Food Code will require that cold holding temperature be reduced to 41 °F.
Norovirus, the leading cause of food-borne illness in the U.S., has an economic burden that is
significantly less than listeriosis per each case. However, the total burden of norovirus to the
economy is more than twice than that of Listeria. The no bare-hands provision of the Guam
Food Code will tackle the problem of norovirus by minimizing the potential contamination of
food that can occur from using bare hands, the primary vehicle of the transmission.
As previously noted, from the period of 2002-2011, there were 1,584 diseases reported in Guam
that were of types associated with the consumption of contaminated food or water. While it’s
uncertain what percentage of this total is attributed directly to foods, or even foods that
originated from food facilities, it would not be unreasonable to assume that half of those which
were true foodborne illness outbreaks were linked to commercial establishments. According to
the Centers for Disease Control and Prevention, half of all foodborne illness outbreaks occurring
in the United States are associated with restaurants6. These outbreaks, involving multiple
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Economic Impact Statement (Final 04.03.13)
Guam Food Code
Division of Environmental Health, DPHSS
individuals per event, were cases that were documented as result of medical treatments they had
received; it did not include cases which were not seen by local clinic or hospital and thus never
reported. It is not uncommon for food-borne illnesses to have gone unreported if the symptoms
were not severe enough for the afflicted individuals to seek medical treatment. Therefore, the
data provided above for Guam is very likely to be significantly less than the actual number of
food-borne diseases that occurred.
In 2006, over 100 elementary school students became ill at a local elementary school. The
investigation alone cost DEH several hundred man-hours of work and the loss of 1-2
instructional days for over 200 students. The school cafeteria, regulated by DEH, which served
lunch at the school, was implicated as the source of the outbreak. Five years later, on May 12,
2011, Guam experienced the largest food-borne illness outbreak recorded on Guam in the last
twenty years; it involved 370 students, faculty, and staff from five public schools who became ill
after consuming egg salad sandwiches contaminated with Staphylococcus aureus enterotoxin that
were prepared and served by a vendor contracted by the local school department. The outbreak
resulted in the activation of the emergency operation center by the Guam Office of Homeland
Security with the involvement of several government agencies. The investigation took the
Division of Environmental Health over a month to complete.
Using Scharff’s study, which noted the average cost of $695 per case for Staphylococcus aureus,
the financial burden of the outbreak that occurred at the five local schools alone in 2011 could
have been $257,150 from just the health impact alone. The total amount would be much higher
if government personnel, equipment, and other expended resources were included in the
calculation.
Guam averages over 1,000 reported gastroenteritis cases a year, and if 20% of the infections are
caused by the norovirus, as reported by CDC, then it may be assumed that 200 of the island’s
reported incidents are due to the virus. Furthermore, the number of actual food-borne illnesses
linked to this estimated 200 annual gastroenteritis infections may be considerable since norovirus
infections account for nearly 60% of all known foodborne illnesses in the U.S. The
implementation of the no bare-hands contact provision may reduce the number of gastroenteritis
occurring on Guam.
Also, if the Guam Food Code can prevent even a single case of Listeria through the lowering of
the cold holding temperature, Guam can prevent the anticipated economic burden of $1,282,069
to treat the case. Thus, theoretically, the implementation of the Guam Food Code could
essentially offset the total financial impact the Code will have on the industry if the island can
prevent even a single case of Listeria infection that can arise from food.
The implementation of the Guam Food Code will not assure that all food-borne diseases will be
prevented on Guam. However, it will reduce the potential of these illnesses from occurring, and
thus, also reducing the estimated $41.3 million annual economic burden to the island.
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III. Potential Increase or Decrease to Cost of Living or Price of good or service
The direct economic impact to the industry from the adoption of the Guam Food Code is
estimated to be $1,882,914.80 (excluding the $6,000 financial impact to DPHSS) in the first
year, which equals to $1,139.09 per each retail food facility, or $94.92 per month, and therefore,
about $3.06 a day. The following years, the total annual impact to the industry will be reduced
to $1,142,943.30, or $691.44 per facility for $57.62/mo. ($1.86/day).
It is unlikely the increased cost from implementing the Guam Food Code will be passed down to
the employees or customers when the expected cost will be less than $2.00 per day after the first
year. Larger businesses may be able to readily absorb the increased cost without hardship. Even
the smaller businesses should be able to handle the nominal cost increase since their actual
expenses resulting from the adoption of the code would be proportional to the size of their
operation. The greatest cost impact of implementing the Guam Food Code derives from the need
to replace the businesses’ refrigeration unit. As noted earlier, the actual cost may be much less
based on the observation of DEH inspectors and the findings of North Carolina’s own economic
impact study. Those retail food facilities in need of replacing their unit(s) would probably have
to do so even without the adoption of the law since their existing unit(s) may not be properly
functioning and/or insufficient to handle the current operation of the establishments.
A reduction in the cost of living that may result from the adoption of the Guam Food Code could
be attributed to the decrease in the incidence of food-borne illness, or other diseases, caused by
improved compliance inspections of regulated facilities. However, the confirmation of such
consideration may require more thorough analysis.
IV. Direct or Indirect Impact of Employment
Adverse impact to employment is not expected from the adoption of the Guam Food Code. The
direct impact may occur from businesses needing to hire additional managers to ensure their
establishments have a certified supervisor or manager at all time during its operation. Indirect
impact to employment could result from existing certified managers required to work longer or
additional hours to comply with the Guam Food Code.
V. Increase or decrease in cost of business
The retail food facilities will be the primary entities that will experience increased cost of doing
business from the adoption of the Guam Food Code. The additional expenses they will bear will
derive from the procurement of supplies, such as gloves, utensils, labels, and other materials to
meet the consumer advisory and no bare-hand contact provisions of the Code; replacement or
retrofitting of their refrigeration unit(s) to meet the new cold holding temperature; and the
training and certification of their supervisors or managers in food safety knowledge and its
application in the workplace. The expenses the retail food facilities will incur will decrease after
the first year of the Code’s implementation.
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Economic Impact Statement (Final 04.03.13)
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Other businesses, whether dealing with food or other goods, are not expected to experience any
direct increase in cost of business if the Guam Food Code is adopted.
VI. Adverse or beneficial economic impact
The adoption and implementation of the Guam Food Code will certainly have a financial impact
on the industry as retail food facilities will be required to implement new practices in their
operation and possibly replace one or more pieces of their equipment. While these additional
costs may be deemed as an adverse impact to the affected businesses, the overall impact will be
beneficial to the economy and the health of the population from the anticipated reduction in the
number of foodborne illness incidents on the island and its associated economic burden.
Based on existing national figures and studies, the cost of treating food-borne illnesses can be
enormous, and preventing just a fraction of the diseases, or even a single costly infection, can
offset the costs the industry may incur as a whole. For example, preventing even one case of
listeriosis through the implementation of the lowered cold-holding temperature, as required in
the code, could reduce the financial burden that exceeds one million dollars per case. Guam has
been fortunate that no listeriosis case been reported in the past decade, and the adoption of the
Guam Food Code is one preventive measure that the island can readily put in practice.
The implementation of the no bare-hand contact provision of the Guam Food Code should also
have beneficial economic impact to the island. As CDC has indicated, norovirus is now the
leading cause of severe gastroenteritis in U.S. children, with 1 in 278 children being hospitalized
by the illness by the time they turn 5 years of age. The nearly 1 million pediatric medical care
visits in 2009-2010 in the U.S. amounted to hundreds of million dollars in treatment costs each
year. Thus, with the Code’s adoption it can be expected that the incidence of norovirus and its
economic burden can be reduced in Guam’s vulnerable population.
Studies have shown that the presence of a certified manager in a food facility reduces the number
of critical violations, and restaurants with such managers will less likely be involved in
foodborne disease outbreaks than were restaurants without managers certified in food safety7,8.
According to the CDC, “This finding is important because it suggests that restaurant manager
food safety certification may provide a protective effect against foodborne illness.”
Consequently, a reduction in the number of food-borne illnesses translates to reduced economic
burden to the population.
The anticipated reduction of foodborne illnesses on Guam, which is expected to occur from the
implementation of the proposed Guam Food Code, should consequently reduce the economic
burden these diseases have on the island and its people. These cost benefits should outweigh the
actual and imagined costs that the industry may experience from the adoption of the Code.
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REFERENCES
1
Painter, JA; Hoekstra, RM; Ayers, T; Tauxe, RV; Braden, CR; Angulo, FJ; et al. Attribution of
foodborne illnesses, hospitalizations, and deaths to food commodities by using outbreak data,
United States, 1998–2008. Emerging Infectious Diseases [Internet]. 2013 Mar [date cited].
http://dx.doi.org/10.3201/eid1903.111866
2
Haddock, Robert. Annual Summary of Notifiable Diseases, Guam - 2011. Office of
Epidemiology and Research, Department of Public Health and Social Services. 2012.
3
Haddock, Robert. Personal communication via email on March 24, 2013.
4
Centers for Disease Control and Prevention. Norovirus is now the leading cause of severe
gastroenteritis in U.S. Children. Press Release. March 21, 2013.
http://www.cdc.gov/media/releases/2013/p0321_norovirus_children.html
5
Bureau of Labor Statistics. May 2011 state occupational employment and wage estimates –
Guam. Department of Labor. http://www.bls.gov/oes/current/oes_gu.htm
6
Division of Public Health. Fiscal impact of 2009 FDA Food Code Adoption. North Carolina
Department of Health and Human Services. February 2012.
http://cph.publichealth.nc.gov/Rules/EnvHealth/FoodCodeOSBMapprovedDHHS_02102012.pdf
7
Scharff, Robert L. Economic burden from health losses due to foodborne illness in the United
States. Journal of Food Protection. Vol. 75, No. 1, pp. 123-131.
8
Brown, Laura and Wigington, Pam. EHS-Net: Improving restaurant food safety one study at a
time. Centers for Disease Control and Prevention. February 7, 2013.
http://www.cdc.gov/nceh/ehs/Docs/CDC-Connects-EHS-Net.pdf
9
Cates, SC; Muth MK; Karns, SA; Penne MA; Stone CN; Harrison JE; and Radke, VJ. Certified
kitchen managers: do they improve restaurant inspection outcomes? Journal of Food Protection.
Vol. 72, No. 2, 2009, pp. 384-391.
http://www.cdc.gov/nceh/ehs/ehsnet/Docs/JFP_Certified_Kitchen_MGRs.pdf
10
Hedberg, CW; Smith, SJ; Kirkland, E; Radke, V; Jones, TF; Selman, CA; et al. Systemic
environmental evaluations to identify food safety differences between outbreak and nonoutbreak
restaurants. Journal of Food Protection. Vol. 69, No. 11, pp. 2697-2702.
http://www.cdc.gov/nceh/ehs/ehsnet/Docs/JFP_Sys_Env_Eval_Id_Food_Safety_bw_OB_NOB_
Rest.pdf
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Preface
1. FOODBORNE ILLNESS ESTIMATES, RISK FACTORS , AND
INTERVENTIONS
2. PURPOSE, AND AUTHORITY
3. PUBLIC HEALTH AND CONSUMER EXPECTATIONS
4. ADVANTAGE OF UNIFORM STANDARDS
5. DISCUSSION OF HACCP AND THE GUAM FOOD CODE
6. INFORMATION TO ASSIST THE USER
1. FOODBORNE ILLNESS ESTIMATES, RISK FACTORS , AND
INTERVENTIONS
Foodborne illness in the United States is a major cause of personal distress, preventable
death, and avoidable economic burden. The U.S. Centers for Disease Control and
Prevention (2011) estimates that foodborne disease causes approximately 48 million
illnesses, 128,000 hospitalizations, and 3,000 deaths in the United States each year.
For many victims, foodborne illnesses results only in discomfort or lost time from the
job. For some, especially preschool age children, older adults in health care facilities,
and those with impaired immune systems, foodborne illness is more serious and may be
life threatening.
The annual cost of foodborne illness in terms of pain and suffering, reduced productivity,
and medical costs are estimated to be $10 - $83 billion. While technological advances
such as pasteurization and proper canning have all but eliminated some disease, new
causes of foodborne illness have been identified. Surveillance of foodborne illness is
complicated by several factors. The first is underreporting. Although foodborne illness
can be severe or even fatal, milder cases are often not detected through routine
surveillance. Second, many pathogens or agents that have not yet been identified and
thus cannot be diagnosed, cause some proportion of foodborne illness.
Epidemiological outbreak data repeatedly identify five major risk factors related to
employee behaviors and preparation practices in retail and food service establishments as
contributing to foodborne illness:
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



Improper holding temperatures,
Inadequate cooking, such as undercooking raw shell eggs,
Contaminated equipment,
Food from unsafe sources, and
Poor personal hygiene
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The Guam Food Code addresses controls for risk factors and further establishes 5 key
public health interventions to protect consumer health. Specifically, these interventions
are: demonstration of knowledge, employee health controls, controlling hands as a
vehicle of contamination, time and temperature parameters for controlling pathogens, and
the consumer advisory. The first two interventions are found in Chapter 2 and the last
three in Chapter 3.
2. PURPOSE AND AUTHORITY
(A) Purpose
The Guam Food Code (the “Code’) will replace the existing “Rules and Regulations
Relative to Eating and Drinking Establishments” which was adopted in 1984 to regulate
the sanitary operation of commercial food facilities that provide food directly to
consumers so to prevent food-borne illnesses from occurring. Since its adoption, there
have been significant changes in how the public eats, where they eat, and what they eat.
There have also been many advances in food science and technology. To keep up with
the times and these transformations, the Division of Environmental Health of the
Department of Public Health and Social Services has adopted the Code, which mirrors
the Model Food Code that is developed and maintained by the U.S. Food and Drug
Administration (USFDA).
The Model Food Code was created by the USFDA to assist food control jurisdictions at
all levels of government by providing them with a scientifically sound technical and legal
basis for regulating the retail segment of the food industry. The retail segment includes
those establishments or locations in the food distribution chain where the consumer takes
possession of the food. The Model Food Code is neither federal law nor federal
regulation and is not preemptive. Rather, it represents USFDA’s best advice for a
uniform system of regulation to ensure that food at retail is safe and properly protected
and presented. Although not federal requirements, the Model Food Code provisions are
designed to be consistent with federal food laws and regulations, and are written for ease
of legal adoption at all levels of government.
Although much of the provisions of the (2005) Model Food Code were retained in the
Guam Food Code, some changes were made to reflect the comments and inputs of the
Guam Food Safety Task Force (GFSTF). The GFSTF was established in 2000 to develop
a comprehensive food safety system for Guam, and one of its primary missions was for
the adoption of the Model Food Code. The task force is comprised of representatives
from the island’s food industry, academia, local regulatory and water agencies, healthcare
community, a social service organization, and the military.
(B) Authority
The Division of Environmental Health is authorized to promulgate rules and regulations for
the control of food facilities pursuant to §21102, Chapter 21 of Title 10 Guam Code
Annotated.
Preface ii
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3. PUBLIC HEALTH AND CONSUMER EXPECTATIONS
It is a shared responsibility of the food industry and the government to ensure that food
provided to the consumer is safe and does not become a vehicle in a disease outbreak or
in the transmission of communicable disease. This shared responsibility extends to
ensuring that consumer expectations are met and that food is unadulterated, prepared in a
clean environment, and honestly presented.
Accordingly, the provisions of the Guam Food Code provide a system of prevention and
overlapping safeguards designed to minimize foodborne illness; ensure employee health,
industry manager knowledge, safe food, nontoxic and cleanable equipment, and
acceptable levels of sanitation on food establishment premises; and promote fair dealings
with the consumer.
4. ADVANTAGE OF UNIFORM STANDARDS
The advantages of well-written, scientifically sound, and up-to-date model codes have
long been recognized by industry and government officials. Industry conformance with
acceptable procedures and practices is far more likely where regulatory officials “speak
with one voice” about what is required to protect the public health, why it is important,
and which alternatives for compliance may be accepted. The Guam Food Code, which
mirrors the model code, will be useful to businesses in that it provides accepted standards
that can be applied in training and quality assurance programs. Several states have
adopted the model code in parts or in whole.
5. DISCUSSION OF HACCP AND THE GUAM FOOD CODE
A HACCP Plan under the Guam Food Code is required only under certain circumstances;
it is not a general requirement. Thus, a HACCP Plan will not be required from the
majority of all food facilities that will be governed by the Guam Food Code.
HACCP plans under the Guam Food Code variance process are provided to the Division
of Environmental Health to enable the regulatory authority to assess whether the
establishment has designed a system of controls sufficient to ensure the safety of the
product. It must include flow diagrams, product formulations, training plans, and
corrective action plan. The plans will be reviewed outside the food establishment and, in
most cases, in the absence of any historical performance information for the product at
that establishment. Therefore, the plan must contain sufficient detail to allow the
regulator to fully understand the operations and the intended controls. Products requiring
a variance are those which are deemed to be potentially hazardous (time/temperature
control for safety) and for which retail production would otherwise be prohibited.
To assist food establishments in applying HACCP principles at retail, USFDA has issued
a document entitled: Managing Food Safety: A HACCP Principles Guide for Operators
of Food Service, Retail Food Stores, and Other Food Establishments at the Retail Level.
Preface iii
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This document is available from FDA and can be found on the FDA Web Page at
http://vm.cfsan.fda.gov/~ear/retail.html.
6. INFORMATION TO ASSIST THE USER
The Guam Food Code provisions address essentially four areas: personnel (Chapter 2),
food (Chapter 3), equipment/facilities/supplies (Chapters 4-7), and compliance
enforcement (Chapter 8). The structural nomenclature of the document is as follows:
Chapter
Part
Subpart
Section (§)
Paragraph (¶)
Subparagraph
9
9-1
9-101
9-101.11
9-101.11(A)
9-101.11(A)(1)
Code provisions are either appropriate for citing and debiting on an inspection report or
they are not. Those not intended for citing/debiting are identified by the digits following
the decimal point in the numbering system. These “nondebitable” provisions fall into
two categories, those that end with two digits after the decimal point and the last digit is a
zero, e.g., § 1-201.10; and those that end with three digits after the decimal point and the
last 2 digits are zeroes, e.g., § 88-805.100.
Two types of internal cross referencing are widely used throughout the Code to eliminate
the need for restating provisions.
A. The first type of cross reference uses phrases that contain the word “under,”
e.g., “as specified under … (followed by the relevant portion of the Code).”
The purpose of this type of cross reference is to:
1) Alert the reader to relevant information, and
2) Provide a system by which each violation is recorded under the one
most appropriate provision. This type of cross reference signals to the
reader the provision of the Code under which a certain violation is
properly cited/debited.
B. The second type of cross reference uses phrases that contain the word “in,”
e.g., “as specified in… (followed by the relevant portion of the Code).”
The purpose of this type of cross reference is to:
1) Indicate the specific provisions of a separate document such as a
federal regulation that are being incorporated by reference in the
requirement of the Code, e.g., ¶3-201.11(C); or
Preface iv
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8
9
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23
24
25
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32
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34
35
36
37
38
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40
41
42
43
44
45
46
2) Refer the reader to a nondebitable provision of the Code which
provides further information for consideration, such as provision for an
exception or for an allowance to comply via an alternative method.
For example, ¶ 3-201.16(A) begins with “Except as specified in ¶
(B)…” and ¶ (B) states the relevant exceptions in to ¶ (A). Paragraph
3-201.11(E) states in part, “…as specified in ¶ 3-401.11(C)” and ¶ 3401.11(C) provides for an allowance to serve or sell raw or
undercooked, whole-meat, intact beef steaks in ready to eat form.
If you review the exception in ¶ 3-201.16 (B) and the allowance in ¶ 3401.11(C), you will see that exceptions and allowances often contain
conditions of compliance, i.e., conditions that must be met in order for
the exception or allowance to convey.
Based on the violation being cited, the substance of the text being referred to, and the
context in which the reference is made, users of the Code must infer the intent of the
cross reference. That is, the user must determine if the cross reference simply alerts the
user to additional information about the requirement or if the cross reference:


Sends (via the word “under”) the citing/debiting to another Code
provision;
Or
Incorporates (via the word “in”) the referenced requirements into the
Code provision.
The Guam Food Code presents requirements by principle rather than by subject. For
example, equipment requirements are presented under headings such as Materials, Design
and Construction, Numbers and Capacities, Location and Installation, and Maintenance
and Operation rather than by refrigerators, sinks, and thermometers. In this way
provisions need be stated only once rather than repeated for each piece or category of
equipment. Where there are special requirements for certain equipment, the requirement
is delineated under the appropriate principle (e.g., Design and Construction) and listed
separately.
Portions of some sections are written in italics. These provisions are not requirements,
but are provided to convey relevant information about specific exceptions and alternative
means for compliance. Italics are pursuant to a preceding provision that states a
requirement, to which the italics offer an exception or another possibility. Italicized
sections usually involve the words “except for,” “may,” “need not” or “does not apply.”
See ¶3-202.18(D).
Requirements contained in the Guam Food Code are presented as being in one of 3
categories of importance: critical; “swing” (i.e., those that may or may not be critical
depending on the circumstances); and noncritical. An asterisk * after a tagline (which is
the language immediately following section number that introduces the subject of the
Preface v
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3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
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21
22
23
24
25
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27
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31
32
33
34
section) indicates that all of the provisions within that section are critical unless otherwise
indicated, as follows:
Any provisions that are “swing” items are followed by the bold, superscripted letter S
and any provisions that are noncritical are followed by the bold, superscripted letter N.
Any unmarked provisions within a section that has an asterisked tagline are critical.
All provisions following a tagline that is not marked with an asterisk are noncritical.
The following conventions are used in the Guam Food Code. “Shall” means that act is
imperative, i.e., “shall” constitutes a command. “May not” means absolute prohibition.
“May” is permissive and means the act is allowed. The term “means” is followed by a
declared fact.
Defined words and terms are in “small caps” in the text of the Guam Food Code chapters
to alert the reader to the fact that there is a specific meaning assigned to those words and
terms and that the meaning of a provision is to be interpreted in the defined contact. A
concerted effort was also made to place in “small caps” all forms and combinations of
those defined words and terms that were intended to carry the weight of the definition.
The annexes located at the back of the document can provide tremendous assistance to
those charged with applying the Guam Food Code provisions. No reference is made in
the text of a provision to the annexes which support its requirements. This is necessary in
order to keep future laws or other requirements based on the model Food Code “clean.”
However, the annexes are provided specifically to assist the regulatory authority apply
the provisions uniformly and effectively.
It is, therefore, important for users to preview the subject and essence of each of the
annexes before using the document. Some of the annexes (e.g. Public Health Reasons)
are structured to present the information by the specific Guam Food Code item number to
which they apply. Other annexes provide information and materials intended to be
helpful to the user such as model forms that can be used, a delineation of the principles of
HACCP, guidelines for establishment inspection, and criteria for certain food processes
for use in evaluating proposed HACCP plans.
Preface vi
07.10.13
1
Chapter
2
8
3
Parts
Compliance and Enforcement
4
8-1
CODE APPLICABILITY
5
8-2
PLAN SUBMISSION AND APPROVAL
6
8-3
PERMIT TO OPERATE
7
8-4
INSPECTION AND CORRECTION OF VIOLATIONS
8
8-5
PREVENTION OF FOODBORNE DISEASE TRANSMISSION BY
9
EMPLOYEES
10
11
8-1
12
CODE APPLICABILITY
Subparts
13
8-101
Use for Intended Purpose
14
8-102
Additional Requirements
15
8-103
Variances
16
17
Use for
8-101.10
Public Health Protection.
18
Intended
(A)
REGULATORY AUTHORITY
19
Purpose
The
shall
apply this Code to
promote its underlying purpose, as specified in §1-102.10,
20
of safeguarding public health and ensuring that
21
safe, unADULTERATED, and honestly presented
22
offered to the
CONSUMER.
262
FOOD
is
when
07.10.13
(B)
1
In enforcing the provisions of this Code, the
shall assess existing facilities or
REGULATORY
2
AUTHORITY
3
were in use before the effective date of this Code based
4
on the following considerations:
5
(1)
Whether the facilities or
EQUIPMENT
EQUIPMENT are in good
that
repair
6
and capable of being maintained in a sanitary
7
condition;
8
(2)
9
Whether
FOOD-CONTACT SURFACES
comply
with
Subpart 4-101;
10
(3)
Whether the capacities of cooling, heating, and
11
holding
12
4-301.11; and
13
(4)
EQUIPMENT
are sufficient to comply with §
The existence of a documented agreement with the
14
PERMIT HOLDER
15
replaced as specified under ¶ 8-304.11(G) or upgraded
16
or replaced as specified under ¶ 8-304.11(H).
17
Additional
18
Requirements
19
8-102.10
that the facilities or
EQUIPMENT
will be
Preventing Health Hazards, Provision for
Conditions Not Addressed.
(A)
If necessary to protect against public health
HAZARDS
or
20
nuisances, the
21
requirements in addition to the requirements contained in
22
this Code that are authorized by
23
(B)
The
REGULATORY AUTHORITY
REGULATORY AUTHORITY
263
may impose specific
LAW.
shall document the conditions
1
07.10.13
that necessitate the imposition of additional requirements
2
and the underlying public health rationale. The documentation
3
shall be provided to the
4
and a copy shall be maintained in the REGULATORY AUTHORITY’S
5
file for the
6
Variances
8-103.10
PERMIT
applicant or
PERMIT HOLDER
FOOD ESTABLISHMENT.
Modifications and Waivers.
7
The
8
waiving the requirements of this Code if in the opinion of
9
REGULATORY AUTHORITY
REGULATORY AUTHORITY
10
from the
11
AUTHORITY
12
in its records for the
13
8-103.11
14
VARIANCE.
may grant a
VARIANCE
the
a health HAZARD or nuisance will not result
If a
VARIANCE
is granted, the
REGULATORY
shall retain the information specified under § 8-103.11
FOOD ESTABLISHMENT.
Documentation of
Proposed
Variance
and
Justification.
15
Before a
16
the information that shall be provided by the
17
the VARIANCE and retained in the
18
the
19
(A)
20
21
by modifying or
VARIANCE
from a requirement of this Code is
FOOD ESTABLISHMENT
PERSON
APPROVED,
requesting
REGULATORY AUTHORITY'S
file on
includes:
A statement of the proposed
VARIANCE
of the Code
requirement citing relevant Code section numbers;
(B)
An analysis of the rationale for how the potential public health
22
HAZARDS
and nuisances addressed by the relevant Code
23
sections will be alternatively addressed by the proposal; and
264
(C)
1
A
HACCP
PLAN
if
required
as specified
07.10.13
under
2
¶ 8-201.13(A) that includes the information specified under
3
§ 8-201.14 as it is relevant to the
4
8-103.12
5
If the
6
§ 8-103.10, or a HACCP
7
under § 8-201.13, the
8
(A)
9
VARIANCE
Conformance with Approved Procedures.*
REGULATORY AUTHORITY
grants a
VARIANCE
as specified in
is otherwise required as specified
PLAN
PERMIT HOLDER
Comply with the HACCP
shall:
PLANs
and procedures that
submitted as specified under § 8-201.14 and
10
requested.
are
APPROVED
as
a basis for the modification or waiver; and
11
(B)
Maintain and provide to the
REGULATORY AUTHORITY,
upon
12
request, records specified under ¶¶ 8-201.14(D) and (E) that
13
demonstrate that the following are routinely employed;
14
(1)
Procedures for monitoring the CRITICAL CONTROL
15
(2)
Monitoring of the
16
(3)
Verification of the effectiveness of the operation or
17
CRITICAL CONTROL POINTS,
process, and
18
(4)
19
Necessary corrective actions if there is failure at a
CRITICAL CONTROL POINT.
20
21
22
23
POINTS,
8-2
PLAN SUBMISSION AND APPROVAL
Subparts
8-201
Facility and Operating Plans
265
07.10.13
1
8-202
Confidentiality
2
8-203
Construction Inspection and Approval
When Plans Are Required.
3
4
Facility and
8-201.11
5
Operating Plans
A
PERMIT
applicant or PERMIT HOLDER shall submit to the REGULATORY
6
AUTHORITY
7
approval before:
8
(A)
The construction of a
9
(B)
The conversion of an existing structure for use as a
10
11
properly prepared plans and specifications for review and
ESTABLISHMENT;
(C)
FOOD ESTABLISHMENT;
FOOD
or
The remodeling of a
FOOD ESTABLISHMENT
12
type of
13
under ¶ 8-302.14(C) if the REGULATORY AUTHORITY determines
14
that plans and specifications are necessary to ensure
15
compliance with this Code.
FOOD ESTABLISHMENT
or
or a change of
FOOD
operation as specified
16
8-201.12
Contents of the Plans and Specifications.
17
The plans and specifications for a
18
a
19
required by the
20
operation, type of
21
following information to demonstrate conformance with Code
22
provisions:
23
(A)
FOOD ESTABLISHMENT
FOOD ESTABLISHMENT,
including
specified under §8-201.13, shall include, as
REGULATORY AUTHORITY
FOOD
based on
preparation, and
Intended menu;
266
FOODS
the
type of
prepared, the
1
(B)
2
3
FOOD
07.10.13
to be stored, prepared, and
sold or served;
(C)
4
5
Anticipated volume of
Proposed layout, mechanical
schematics, construction
materials, and finish schedules;
(D)
Proposed
EQUIPMENT
types, manufacturers, model numbers,
6
locations, dimensions, performance capacities, and installation
7
specifications;
8
(E)
9
with the requirements of this Code are developed or are being
10
11
Evidence that standard procedures that ensure compliance
developed; and
(F)
Other information that may be required by the
REGULATORY
12
AUTHORITY
13
conversion or modification, and procedures for operating a
14
FOOD ESTABLISHMENT.
15
8-201.13
16
(A)
for the proper review of the proposed construction,
When a HACCP Plan is Required.
Before engaging in an activity that requires a HACCP PLAN, a
17
PERMIT
18
REGULATORY AUTHORITY for review a properly prepared a HACCP
19
PLAN
20
provisions of this Code if:
21
(1)
22
23
(2)
applicant or
PERMIT HOLDER
shall submit to the
as specified under § 8-201.14 and the relevant
Submission of a HACCP
to
LAW;
A
VARIANCE
267
is
PLAN
required
is required according
as
specified
under
1
Subparagraph
2
¶ 4-204.110(B);
(3)
3
The
3-401.11(D)(3),
REGULATORY AUTHORITY
07.10.13
§ 3-502.11,
or
determines that a
FOOD
4
preparation or processing method requires a VARIANCE
5
based on a plan submittal specified under §
6
8-201.12, an inspectional finding, or a
7
request; and
8
(4)
9
FOOD ESTABLISHMENT that serves to elementary schools
and HIGHLY SUSCEPTIBLE POPULATION, as determined by
10
11
VARIANCE
the
(B)
12
A
PERMIT
REGULATORY AUTHORITY.
applicant or
prepared HACCP
PERMIT HOLDER
PLAN
shall have a properly
as specified under § 3-502.12.
13
8-201.14
Contents of a HACCP Plan.
14
For a FOOD ESTABLISHMENT that is required under § 8-201.13 to have a
15
HACCP PLAN, the plan and specifications shall indicate:
16
(A)
A categorization of the types of POTENTIALLY HAZARDOUS FOODS
17
(TIME/TEMPERATURE
18
specified in the menu such as soups and sauces, salads, and
19
bulk, solid FOODS such as MEAT roasts, or of other FOODS that
20
are specified by the REGULATORY AUTHORITY;
21
(B)
CONTROL FOR SAFETY FOODS)
A flow diagram by specific
22
CRITICAL CONTROL POINTS
23
following:
268
FOOD
that are
or category type identifying
and providing information on the
(1)
1
2
Ingredients, materials, and
EQUIPMENT
07.10.13
used in the
preparation of that FOOD, and
3
(2)
Formulations or recipes that delineate methods and
4
procedural control measures that address the
5
safety concerns involved;
6
(C)
7
8
9
FOOD
FOOD EMPLOYEE and supervisory training plan that addresses
the FOOD safety issues of concern;
(D)
A statement of standard operating procedures for the plan
under consideration including clearly identifying:
10
(1)
Each
11
(2)
The
12
(3)
The method and frequency for monitoring and
CRITICAL CONTROL POINT,
CRITICAL LIMITS
13
controlling each
14
EMPLOYEE
15
(4)
The
for each
CRITICAL CONTROL POINT
designated by the
method
CRITICAL CONTROL POINT,
and
by the
FOOD
PERSON IN CHARGE,
frequency for the
IN
16
CHARGE
17
is following standard operating procedures and
18
monitoring
19
(5)
to routinely verify that the
PERSON
CRITICAL CONTROL POINTS,
Action to be taken by the
20
CRITICAL LIMITS
21
not met, and
22
23
(6)
FOOD EMPLOYEE
for each
PERSON IN CHARGE
CRITICAL CONTROL POINT
Records to be maintained by the
to demonstrate that the HACCP
269
if the
are
PERSON IN CHARGE
PLAN
is properly
07.10.13
1
operated and managed; and
2
(E)
Additional scientific data or other information, as required
3
by the
4
that
5
(F)
REGULATORY AUTHORITY, supporting
safety is not compromised by the proposal.
FOOD
HACCP
the determination
PLAN
required for submission to the
REGULATORY
6
AUTHORITY shall be developed or certified by a PERSON who has
7
obtained a training and credentialing on HACCP from a
8
program that has been evaluated and listed by the REGULATORY
9
AUTHORITY.
10
Confidentiality
8-202.10
Trade Secrets.
11
The
12
accordance with
13
in
14
forms and in the plans and specifications submitted as specified
15
under §§ 8-201.12 and 8-201.14.
REGULATORY
LAW
AUTHORITY
LAW,
shall treat as confidential
in
information that meets the criteria specified
for a trade secret and is contained on inspection report
16
Construction
8-203.10
Preoperational Inspections.
17
Inspection
The
18
and Approval
operational inspections to verify that the
REGULATORY AUTHORITY
shall
conduct one or more
pre-
FOOD ESTABLISHMENT
is
19
constructed and equipped in accordance with the
20
plans and
21
standard operating procedures as specified under ¶ 8-201.12(E),
22
and is in compliance with
APPROVED
APPROVED
modifications of those plans, has established
23
270
LAW
and this Code.
07.10.13
1
8-3
2
PERMIT TO OPERATE
Subparts
3
8-301
Requirement
4
8-302
Application Procedure
5
8-303
Issuance
6
8-304
Conditions of Retention
8-301.11
Prerequisite for Operation.
7
8
Requirement
9
A
10
PERSON
PERMIT
11
Application
12
Procedure
may not operate a
FOOD ESTABLISHMENT
to operate issued by the
8-302.11
without a valid
REGULATORY AUTHORITY.
Submission 30 Calendar Days Before Proposed
Opening.
13
An applicant shall submit an application for a
14
calendar days before the date planned for opening a
15
ESTABLISHMENT.
16
application for a
17
calendar days before the date planned for opening a
18
ESTABLISHMENT
19
requirements established by the
20
by the applicant.
21
8-302.12
22
A
23
to the REGULATORY
PERSON
The
REGULATORY
PERMIT
provided
AUTHORITY
PERMIT
at least 30
FOOD
may accept an
that is less than the minimum 30
the necessary fees
FOOD
and
other
REGULATORY AUTHORITY
are met
Form of Submission.
desiring to operate a
AUTHORITY
271
FOOD ESTABLISHMENT
shall submit
a written application for a
PERMIT
07.10.13
1
on a form provided by the
2
8-302.13
3
To qualify for a
4
(A)
5
REGULATORY AUTHORITY.
Qualifications and Responsibilities of Applicants.
PERMIT,
an applicant shall:
Be an owner of the
FOOD ESTABLISHMENT
or an officer of
the legal ownership;
6
(B)
Comply with the requirements of this Code;
7
(C)
As specified under § 8-402.11, agree to allow access to
8
the
9
information; and
10
(D)
11
Pay
FOOD
the
ESTABLISHMENT
applicable
and
PERMIT
to
fees
provide
at
the
required
time
application is submitted.
12
8-302.14
13
The application shall include:
14
(A)
Contents of the Application.
The name, birth date, mailing address, telephone number,
15
and signature of the
16
the name, mailing address, and location of the
17
ESTABLISHMENT;
18
(B)
PERSON
applying for the
Information specifying whether the
19
owned
20
partnership, or other legal entity;
21
22
23
the
(C)
by
an
association,
and
PERMIT
FOOD
FOOD ESTABLISHMENT
corporation,
is
individual,
A statement specifying whether the
FOOD ESTABLISHMENT:
(1)
and
Is
mobile
or
permanent, and
272
stationary
temporary
or
1
(2)
07.10.13
Is an operation that includes one or more of the
2
following:
3
(a)
Prepares, offers for sale, or serves POTENTIALLY
4
HAZARDOUS FOOD
5
FOR SAFETY FOOD):
6
(i)
7
Only
to
(TIME/TEMPERATURE
order
upon
CONSUMER'S
request,
8
(ii)
In
advance
in
quantities based on
9
projected
10
discards
11
served at an
APPROVED
Using
as
12
(iii)
13
14
a
CONTROL
CONSUMER
FOOD
time
demand
and
that is not sold or
the
frequency, or
public
health
control as specified under § 3-501.19,
(b)
Prepares
POTENTIALLY
HAZARDOUS
FOOD
15
(TIME/TEMPERATURE
16
in advance using a
17
that involves two or more steps which may
18
include
19
(TIME/TEMPERATURE
20
ingredients; cooking; cooling; reheating; hot
21
or cold holding; freezing; or thawing,
22
23
(c)
Prepares
combining
FOOD
CONTROL FOR SAFETY FOOD)
FOOD
preparation method
POTENTIALLY
HAZARDOUS
CONTROL FOR SAFETY FOOD)
as
specified
under
Subparagraph (C)(2)(b) of this section for
273
1
07.10.13
delivery to and consumption at a location off
2
the PREMISES of the
3
it is prepared,
4
(d)
Prepares
FOOD
FOOD ESTABLISHMENT where
as
under
Subparagraph
5
(C)(2)(b) of this section for service to a
6
HIGHLY SUSCEPTIBLE POPULATION,
7
(e)
Prepares only
8
HAZARDOUS
9
SAFETY FOOD),
10
(f)
12
HAZARDOUS
13
SAFETY FOOD);
15
16
CONTROL
OF
or
FOOD
that is not
(TIME/TEMPERATURE
POTENTIALLY
CONTROL FOR
The name, title, address, and telephone number of the
PERSON
(E)
POTENTIALLY
Does not prepare, but offers for sale only
prePACKAGED
(D)
that is not
(TIME/TEMPERATURE
11
14
FOOD
directly responsible for the
FOOD ESTABLISHMENT;
The name, title, address, and telephone number of the
17
PERSON
who functions as the immediate supervisor of the
18
PERSON
specified under ¶ (D) of this section such as the
19
zone, district, or regional supervisor;
20
21
(F)
The names, titles, and addresses of:
(1)
The
PERSONS
comprising the legal ownership as
22
specified under ¶ (B) of this section including the
23
owners and officers, and
274
1
(2)
2
07.10.13
The local resident agent if one is required based
on the type of legal ownership;
3
(G)
4
A statement signed by the applicant that:
(1)
5
Attests to the accuracy of the information provided
in the application, and
6
(2)
Affirms that the applicant will:
7
(a)
Comply with this Code, and
8
(b)
Allow the
9
REGULATORY AUTHORITY
the establishment
as
specified
access to
under
§
10
8-402.11 and to the records specified under
11
§§ 3-203.12 and 5-205.13 and Subparagraph
12
8-201.14(D)(6); and
13
14
(H)
Issuance
Other information required by the
8-303.10
REGULATORY AUTHORITY.
New, Converted, or Remodeled Establishments.
15
For
16
specified under § 8-201.11 the
17
a
18
(A)
A properly completed application is submitted;
19
(B)
The required fee is submitted;
20
(C)
The required plans, specifications, and information are
PERMIT
21
22
23
FOOD ESTABLISHMENTS
REGULATORY AUTHORITY
shall issue
to the applicant after:
reviewed and
(D)
that are required to submit plans as
APPROVED;
and
A preoperational inspection as specified in § 8-203.10
shows that the establishment is built or remodeled in
275
07.10.13
plans and specifications and
1
accordance with the
2
that the establishment is in compliance with this Code.
3
8-303.20
APPROVED
Existing Establishments, Permit Renewal, and
4
Change of Ownership.
5
The
6
FOOD ESTABLISHMENT
7
an existing FOOD ESTABLISHMENT after a properly completed application
8
is submitted, reviewed, and
9
inspection shows that the establishment is in compliance with
REGULATORY AUTHORITY
or may issue a
10
this Code.
11
8-303.30
12
If
13
REGULATORY AUTHORITY
14
that includes:
15
(A)
16
an
may renew a
PERMIT
PERMIT
APPROVED,
for an existing
to a new owner of
the fees are paid, and an
Denial of Application for Permit, Notice.
application
for
a
PERMIT
to
operate is denied, the
shall provide the applicant with a notice
The specific reasons and Code citations for the
PERMIT
denial;
17
(B)
18
The actions, if any, that the applicant must take to qualify
for a
19
(C)
PERMIT;
and
Advisement of the applicant's right of appeal and the
20
process and time frames for appeal that are provided
21
in
22
Conditions of
8-304.10
23
Retention
(A)
LAW.
At the
Responsibilities of the Regulatory Authority
time
a
PERMIT
276
is first issued, the
REGULATORY
AUTHORITY
2
so that the
3
requirements and the conditions of retention, as specified
4
under § 8-304.11, that are applicable to the
5
(B)
shall inform the
07.10.13
about the Code
1
PERMIT HOLDER
is notified of the compliance
PERMIT HOLDER
PERMIT.
Failure to provide the information specified in ¶ (A) of this
6
section does not prevent the
7
taking authorized action or seeking remedies if the
8
HOLDER
9
warning, or directive of the
8-304.11
11
Upon acceptance of the
12
AUTHORITY,
13
(A)
15
the
Post the
PERMIT HOLDER
PERMIT
in order to retain the
in a location in the
§ 8-103.12, and
18
§ 8-201.12;
If a
VARIANCE
APPROVED
FOOD ESTABLISHMENT
operate under a HACCP
21
specified under § 8-103.12;
23
shall:
FOOD ESTABLISHMENT
Immediately contact the
illness of a
plans as specified under
PLAN,
comply with the plan as
REGULATORY AUTHORITY
FOOD EMPLOYEE
277
as specified under
is required under § 8-201.13 to
20
(D)
PERMIT
Comply with the provisions of this Code including the
17
22
REGULATORY
CONSUMERS;
conditions of a granted
(C)
issued by the
PERMIT
16
19
REGULATORY AUTHORITY.
Responsibilities of the Permit Holder.
that is conspicuous to
(B)
PERMIT
fails to comply with this Code or an order,
10
14
from
REGULATORY AUTHORITY
or
to report an
CONDITIONAL EMPLOYEE
as
07.10.13
1
2
specified under ¶ 2-201.11(B);
(E)
Immediately discontinue
operations
3
REGULATORY AUTHORITY
4
exist as specified under § 8-404.11;
5
(F)
Allow representatives of the
6
to
7
§ 8-402.11;
8
(G)
9
if an
the
FOOD
and
notify
the
IMMINENT HEALTH HAZARD
REGULATORY AUTHORITY
as
ESTABLISHMENT
specified
may
access
under
Except as specified under ¶ (H) of this section, replace
existing facilities and
10
with facilities and
11
(1)
The
EQUIPMENT
EQUIPMENT
specified in § 8-101.10
that comply with this Code if:
directs the replacement
REGULATORY AUTHORITY
12
because the facilities and
13
public health
14
comply with the criteria upon which the facilities and
15
EQUIPMENT
16
(2)
The
HAZARD
were accepted,
18
change of ownership, or
20
21
directs the replacement
REGULATORY AUTHORITY
of the facilities and
(3)
constitute a
or nuisance or no longer
17
19
EQUIPMENT
The facilities and
EQUIPMENT
EQUIPMENT
because of a
are replaced in the
normal course of operation;
(H)
Upgrade or replace refrigeration
EQUIPMENT
as specified
22
under Subparagraph 3-501.16(A)(2)(b), if the circumstances
23
specified under Subparagraphs (G)(1) - (3) of this section
278
07.10.13
1
do not occur first, and 5 years pass after the
2
AUTHORITY
3
(I)
Comply
REGULATORY
adopts this Code;
with
directives
of the
REGULATORY AUTHORITY
4
including time frames for corrective actions specified in
5
inspection reports, notices,
6
directives issued by the
7
to
8
response to community emergencies;
9
(J)
PERMIT
REGULATORY AUTHORITY
HOLDER'S
FOOD
AUTHORITY
(K)
according to
LAW;
in regard
ESTABLISHMENT
Accept notices issued and served by the
10
11
the
orders, warnings, and other
or
in
REGULATORY
and
Be subject to the administrative, civil, injunctive, and
12
criminal remedies authorized in
13
with
14
AUTHORITY,
15
specified in inspection reports, notices, orders, warnings,
16
and other directives.
this
Code
or
a
LAW
directive
including time
for failure to comply
of
the
REGULATORY
frames for corrective actions
17
8-304.20
Permits Not Transferable.
18
A
19
PERSON,
20
type of operation to another if the
21
the type of operation specified in the application as specified
22
under ¶ 8-302.14(C) and the change in operation is not
23
APPROVED.
PERMIT
shall not be transferred from one
from one
FOOD ESTABLISHMENT
279
FOOD
PERSON
to another
to another, or from one
operation changes from
07.10.13
1
2
8-4
3
INSPECTION AND CORRECTION OF VIOLATIONS
Subparts
4
8-401
Frequency
5
8-402
Access
6
8-403
Report of Findings
7
8-404
Imminent Health Hazard
8
8-405
Violation of Critical Item
9
8-406
Noncritical Violation
8-401.10
Establishing Inspection Interval.
10
11
12
Frequency
(A)
Except as specified in ¶¶ (B) and (C) of this section, the
13
REGULATORY AUTHORITY
14
at least once every 3 months.
15
(B)
The
shall inspect a
REGULATORY AUTHORITY
16
of the inspection if:
17
(1)
The
FOOD ESTABLISHMENT
may decrease the qualification
FOOD ESTABLISHMENT
is fully operating under an
18
APPROVED
19
under § 8-201.14 and ¶¶ 8-103.12(A) and (B);
20
(2)
and validated HACCP
PLAN
as specified
The establishment's operation involves only coffee
21
service and other unpackaged or prePACKAGED
22
that is not POTENTIALLY HAZARDOUS (TIME/TEMPERATURE
23
CONTROL FOR
280
SAFETY FOOD)
FOOD
such as carbonated
1
BEVERAGES
2
popcorn, and pretzels.
3
(C)
The
and snack
REGULATORY AUTHORITY
FOOD
07.10.13
such as chips, nuts,
shall periodically
4
throughout
5
ESTABLISHMENT and TEMPORARY FOOD SERVICE ESTABLISHMENT
6
that prepares, sells, or serves unPACKAGED
7
HAZARDOUS FOOD
8
FOOD)
and that:
9
(1)
Has improvised rather than permanent facilities or
its
PERMIT
period
(TIME/TEMPERATURE
a
inspect
TEMPORARY
FOOD
POTENTIALLY
CONTROL FOR SAFETY
10
EQUIPMENT
for accomplishing functions such as
11
handwashing,
12
temperature control, WAREWASHING, providing DRINKING
13
WATER,
14
rodent control; or
FOOD
preparation and protection,
FOOD
waste retention and disposal, and insect and
15
(2)
16
8-401.20
17
Within the parameters specified in § 8-401.10, the
18
AUTHORITY
19
based upon its assessment of a
20
compliance with this Code and the establishment's potential as a
21
vector of foodborne illness by evaluating:
22
(A)
23
Has inexperienced
FOOD EMPLOYEES.
Performance- and Risk-Based.
REGULATORY
shall prioritize, and conduct more frequent inspections
FOOD ESTABLISHMENT'S
history of
Past performance, for nonconformance with Code
HACCP
PLAN
requirements that are critical;
281
or
1
(B)
07.10.13
Past performance, for numerous or repeat violations of
Code or HACCP
2
3
(C)
4
PLAN
requirements that are noncritical;
Past performance, for complaints investigated and found
to be valid;
(D)
5
6
The
HAZARDS
associated with the particular
FOODS
that are
prepared, stored, or served;
7
(E)
8
The type of operation including the methods and extent
of
FOOD
storage, preparation, and service;
9
(F)
The number of people served; and
10
(G)
Whether the population served is a
11
HIGHLY SUSCEPTIBLE
POPULATION.
12
8-402.10
13
An authorized representative of the
14
inspects
15
compliance with this Code shall have the knowledge, skills, and
16
ability to adequately perform the required duties.
17
Access
Competency of Inspectors.
a
8-402.11
FOOD ESTABLISHMENT
REGULATORY AUTHORITY
or
who
conducts plan review for
Allowed at Reasonable Times after Due Notice.
18
After the
19
provides notice of the purpose of, and an intent to conduct, an
20
inspection, the
21
AUTHORITY
22
compliance with this Code by allowing access to the establishment,
23
allowing inspection, and providing information and records
REGULATORY AUTHORITY
to
PERSON
presents official credentials and
IN CHARGE
determine
282
if
the
shall allow the
REGULATORY
FOOD ESTABLISHMENT
is
in
07.10.13
1
specified in this Code and to which the
2
is entitled according to
3
hours of operation and other reasonable times.
4
8-402.20
5
LAW,
REGULATORY AUTHORITY
during the
FOOD ESTABLISHMENT'S
Refusal, Notification of Right to Access, and Final
Request for Access.
6
If a
7
REGULATORY AUTHORITY
8
(A)
PERSON
denies access to the
Inform the
(1)
REGULATORY AUTHORITY,
shall:
PERSON
that:
The
PERMIT HOLDER
10
the
REGULATORY
11
§ 8-402.11 of this Code,
9
12
(2)
is required to allow access to
AUTHORITY
as
specified
retention of a
14
as specified under ¶ 8-304.11(F), and
(3)
16
under
Access is a condition of the acceptance and
13
15
the
FOOD ESTABLISHMENT PERMIT
If access is denied, the
to operate
FOOD ESTABLISHMENT PERMIT
may be suspended by the
REGULATORY AUTHORITY.
17
(B)
Make a final request for access.
18
8-402.30
Refusal, Reporting.
19
If after the
REGULATORY
20
provides notice
21
authority upon which access is requested, and makes a final
22
request for access as specified in § 8-402.20, the
23
CHARGE
as
continues to
AUTHORITY
specified
REFUSE
283
presents
credentials and
under § 8-402.11, explains
access, the
the
PERSON IN
REGULATORY AUTHORITY
1
07.10.13
shall provide details of the denial of access on an inspection
2
report form.
3
8-402.40
4
If denied access to a
5
purpose
6
AUTHORITY
7
ESTABLISHMENT.
8
Report of
8-403.10
9
Findings
The
Refusal, Automatic Suspension of Permit.
FOOD ESTABLISHMENT
for an authorized
and after complying with § 8-402.20, the
shall immediately suspend
the
PERMIT
REGULATORY
of the
FOOD
Documenting Information and Observations.
REGULATORY AUTHORITY
10
report form:
11
(A)
shall document on an inspection
Administrative information about the
12
legal identity,
street
13
establishment
and
14
8-302.14(C), inspection date, and other information such
15
as type of water supply and
16
the
17
and
18
(B)
PERMIT, and
and
FOOD ESTABLISHMENT'S
mailing
operation
as
addresses, type of
specified
SEWAGE
under
¶
disposal, status of
personnel certificates that may be required;
Specific factual observations of violative conditions or other
19
deviations from this Code that require correction by the
20
PERMIT HOLDER
21
(1)
including:
Failure of the
PERSON IN CHARGE
22
knowledge
of
foodborne
23
application
of
HACCP
284
to demonstrate the
illness
principles,
prevention,
and
the
1
07.10.13
requirements of this Code as specified under §
2
2-102.11,
(2)
3
Failure of
FOOD EMPLOYEES, CONDITIONAL EMPLOYEES,
4
and the
5
medical condition as specified under ¶¶ 2-201.11(B)
6
and (D),
PERSON IN CHARGE
7
(3)
Nonconformance with
8
(4)
Failure
9
to report a disease or
CRITICAL ITEMS
of the appropriate
demonstrate
knowledge
of,
EMPLOYEES
and
perform
11
monitoring, verification,
and
12
practices required by the
REGULATORY AUTHORITY
13
specified under § 8-103.12,
(5)
Failure of the
accordance with, the procedural,
PERSON IN CHARGE
action
as
to provide records
required
16
determining conformance with a HACCP
17
specified under Subparagraph 8-201.14(D)(6), and
(6)
19
the
corrective
15
18
by
to
ability to
10
14
in
their
FOOD
of this Code,
Nonconformance with
REGULATORY AUTHORITY
CRITICAL LIMITS
PLAN
for
as
of a HACCP
PLAN.
20
8-403.11
21
(A)
Every
Grading of Food Establishment
FOOD
ESTABLISHMENT
22
designated by the
23
stating the grade received
285
shall display in a place
REGULATORY
at
AUTHORITY,
a placard
the time of the most
1
recent
2
REGULATORY AUTHORITY
3
placard.
4
(B)
5
6
inspection
TEMPORARY
of
07.10.13
establishment. Only the
the
may issue, move, or remove such
FOOD ESTABLISHMENT
shall not be subject to
grading.
(C)
7
Grades of
1)
8
FOOD ESTABLISHMENT
Grade A. A
shall be as follows:
FOOD ESTABLISHMENT
having a demerit
score of not more than ten (10).
2)
9
Grade B. A
FOOD ESTABLISHMENT
having a demerit
10
score of more than ten (10) but no more than
11
twenty (20).
12
3)
Grade C. A
FOOD ESTABLISHMENT
having a demerit
13
score of more than twenty (20) but no more than
14
forty (40).
15
4)
16
Grade D. A
FOOD ESTABLISHMENT having a demerit score of
more than forty (40).
17
5)
Notwithstanding
the
grade criteria established above,
18
whenever a second consecutive violation of the same item
19
of 2, 4, or 6 demerit points is discovered, the PERMIT
20
may
21
ESTABLISHMENT
22
grade.
23
24
(D)
be
Immediately
AUTHORITY
suspended,
or
in
lieu thereof,
the FOOD
shall be downgraded to the next lower
following such inspection, the
REGULATORY
shall post the appropriate grade at the
286
FOOD
07.10.13
1
2
ESTABLISHMENT.
8-403.30
3
Issuing Report and Obtaining Acknowledgment of
Receipt.
4
At the conclusion of the inspection and according to
5
REGULATORY AUTHORITY
6
inspection report and the notice to correct violations to the
7
PERMIT HOLDER
8
signed acknowledgment of receipt.
9
8-403.40
10
The
11
(A)
LAW,
the
shall provide a copy of the completed
or to the
PERSON IN CHARGE,
and request a
Refusal to Sign Acknowledgment.
REGULATORY AUTHORITY
Inform
a
shall:
PERSON
who
declines
to
sign
an
12
acknowledgment of receipt of inspectional findings as
13
specified in § 8-403.30 that:
14
(1)
15
16
An acknowledgment of receipt is not an agreement
with findings,
(2)
Refusal to sign an acknowledgment of receipt will
17
not affect the
18
the violations noted in the inspection report within
19
the
20
(3)
PERMIT HOLDER'S
obligation to correct
time frames specified, and
A refusal to sign an acknowledgment of receipt
21
is noted in the inspection report and conveyed to
22
the
23
FOOD ESTABLISHMENT;
REGULATORY AUTHORITY'S
287
and
historical record for the
(B)
1
2
Make a final request that the
PERSON IN CHARGE
07.10.13
sign an
acknowledgment receipt of inspectional findings.
3
8-403.50
4
Except as specified in § 8-202.10, the
5
shall treat the
6
shall make it available for disclosure to a
7
it as provided in
8
Imminent Health
8-404.11
9
Hazard
(A)
Public Information.
REGULATORY AUTHORITY
inspection report as a public document
PERSON
and
who requests
LAW.
Ceasing Operations and Reporting.
Except as specified in ¶ (B) of this section, a
PERMIT
10
HOLDER
11
the
12
may exist because of an emergency such as a fire, flood,
13
extended interruption of electrical or water service,
14
backup, misuse of
15
of an apparent foodborne illness outbreak, gross insanitary
16
occurrence or condition, or other circumstance that may
17
endanger public health.
18
B)
A
shall immediately discontinue operations and notify
REGULATORY AUTHORITY
PERMIT HOLDER
if an
IMMINENT HEALTH HAZARD
SEWAGE
POISONOUS OR TOXIC MATERIALS,
onset
need not discontinue operations in an
19
area of an establishment that is unaffected by the
20
IMMINENT HEALTH HAZARD.
21
8-404.12
Resumption of Operations.
22
If operations are discontinued as specified under § 8-404.11 or
23
otherwise according to
LAW,
288
the
PERMIT HOLDER
shall obtain
1
approval from the
2
operations.
3
Violation of
8-405.11
4
Critical
(A)
5
Item
REGULATORY
Timely Correction.
Except as specified in ¶ (B) of this section, a
HOLDER
of a
7
actions for a HACCP
8
compliance with its
(B)
PERMIT
shall at the time of inspection correct a violation
6
9
07.10.13
before resuming
AUTHORITY
CRITICAL ITEM
of this Code and implement corrective
PLAN
provision that is not in
CRITICAL LIMIT
Considering the nature of the potential
HAZARD
involved
10
and the complexity of the corrective action needed, the
11
REGULATORY AUTHORITY
12
time frame, not to exceed 10 calendar days after the
13
inspection, for the
PERMIT HOLDER
to correct violations
14
of a
or HACCP
deviations.
15
8-405.20
16
(A)
CRITICAL ITEM
may agree to or specify a longer
PLAN
Verification and Documentation of Correction.
After observing at the time of inspection a correction of a
17
violation of a
18
AUTHORITY
19
the corrective action on the inspection report.
20
(B)
As
CRITICAL ITEM
REGULATORY
shall enter the violation and information about
specified
under ¶ 8-405.11(B),
21
notification that the
22
violation of a
23
at
the
or deviation, the
end
PERMIT
CRITICAL ITEM
of
the
289
HOLDER
or HACCP
specified
after
receiving
has corrected a
PLAN
period
deviation, or
of
time,
the
REGULATORY
2
violation, document the information on an inspection
3
report,
4
AUTHORITY'S
5
Noncritical
8-406.11
6
Violation
(A)
AUTHORITY
and
enter
shall
the
verify
report
correction
07.10.13
of the
1
in the
REGULATORY
records.
Time Frame for Correction.
Except as specified in ¶ (B) of this section, the
PERMIT
7
HOLDER
8
time agreed to or specified by the
9
but no later than 30 calendar days after the inspection.
10
(B)
The
shall correct noncritical violations by a date and
REGULATORY AUTHORITY
may
REGULATORY AUTHORITY
approve a compliance
11
schedule that extends beyond the time limits specified
12
under ¶ (A) of this section if a written schedule of compliance
13
is submitted by the
14
exists or will result from allowing an extended schedule
15
for compliance.
PERMIT HOLDER
and no health
HAZARD
16
17
8-5
PREVENTION OF FOODBORNE DISEASE TRANSMISSION BY
18
EMPLOYEES
19
Subpart
20
8-501
Investigation and Control
8-501.10
Obtaining Information: Personal History
21
22
Investigation
23
and Control
of
Illness, Medical Examination, and Specimen
290
07.10.13
1
Analysis.
2
The
3
cause to believe that
4
EMPLOYEE
5
with a disease in a communicable form that is transmissible
6
through
7
cause a disease that is transmissible through
8
affected with a boil, an infected wound, or
9
infection, by:
10
(A)
REGULATORY AUTHORITY
shall act when it has reasonable
a
FOOD
has possibly transmitted disease;
FOOD;
may be a carrier of
EMPLOYEE
12
transmitting disease
13
deemed appropriate; and
14
(B)
or
Requiring
CONDITIONAL
appropriate
agents
FOOD;
that
or is
acute respiratory
history of the
EMPLOYEE
or making
CONDITIONAL
may be infected
infectious
Securing a confidential medical
11
or
EMPLOYEE
other
FOOD
suspected of
investigations as
medical examinations, including
15
collection of specimens for laboratory analysis, of a
16
suspected
17
8-501.20
FOOD EMPLOYEE
or
CONDITIONAL EMPLOYEE.
Restriction or Exclusion of Food Employee, or
18
Summary Suspension of Permit.
19
Based on the findings of an investigation related to a
20
EMPLOYEE
21
infected or diseased, the
22
order to the suspected
23
PERMIT HOLDER
or
CONDITIONAL EMPLOYEE
FOOD
who is suspected of being
REGULATORY AUTHORITY
may issue an
FOOD EMPLOYEE, CONDITIONAL EMPLOYEE
or
instituting one or more of the following control
291
07.10.13
1
measures:
2
(A)
RESTRICTING the
3
(B)
EXCLUDING the
4
5
(C)
Closing the
a
PERMIT
8-501.30
8
9
FOOD EMPLOYEE
or
CONDITIONAL EMPLOYEE;
or
CONDITIONAL EMPLOYEE;
or
6
7
FOOD EMPLOYEE
FOOD ESTABLISHMENT
by summarily suspending
to operate in accordance with
LAW.
Restriction or Exclusion Order: Warning or Hearing
Not Required, Information Required in Order.
Based on the findings of the investigation as specified in
10
§ 8-501.10 and to control disease transmission, the
11
AUTHORITY
12
suspected
13
warning, notice of a hearing, or a hearing if the order:
14
(A)
15
16
may issue an order of
FOOD EMPLOYEE
or the
States the reasons for the
(B)
EXCLUSION
RESTRICTION
or
to a
without prior
PERMIT HOLDER
States the evidence that the
HOLDER
18
reasons
19
eliminated;
EXCLUSION
that is
(C)
for
the
RESTRICTION
States that the suspected
or
or
EXCLUSION
FOOD EMPLOYEE
HOLDER
22
timely request as provided in
(D)
FOOD EMPLOYEE
PERMIT
shall provide in order to demonstrate that the
21
23
or
ordered;
17
20
RESTRICTION
REGULATORY
or the
are
PERMIT
may request an appeal hearing by submitting a
LAW;
and
Provides the name and address of the
292
REGULATORY
1
AUTHORITY
representative to whom a
2
appeal hearing may be made.
3
8-501.40
4
The
5
CONDITIONAL EMPLOYEE
6
to
Removal of Exclusions and Restrictions.
7
8-501.50
8
The
9
FOOD
REGULATORY AUTHORITY
LAW
07.10.13
for an
request
from
shall release a
RESTRICTION
or
FOOD EMPLOYEE, OR
EXCLUSION
according
and the conditions specified under § 2-201.13.
Examining, Sampling, and Testing Food.
REGULATORY AUTHORITY
may examine, sample, and
test
in order to determine its compliance with this Code.
293
07.10.13
1
Chapter
2
7
3
Parts
Poisonous or Toxic Materials
4
7-1
LABELING AND IDENTIFICATION
5
7-2
OPERATIONAL SUPPLIES AND APPLICATIONS
6
7-3
STOCK AND RETAIL SALE
7-1
LABELING AND IDENTIFICATION
7
8
9
Subparts
10
7-101
Original Containers
11
7-102
Working Containers
Identifying Information, Prominence.*
12
13
Original
7-101.11
14
Containers
Containers of
15
ITEMS
POISONOUS OR TOXIC MATERIALS
and
PERSONAL CARE
shall bear a legible manufacturer's label.
16
Working
7-102.11
Common Name.*
17
Containers
Working containers
used
for
storing
OR
TOXIC
18
MATERIALS
19
supplies shall be clearly and individually identified with the common
20
name of the material.
21
22
7-2
such as cleaners and
POISONOUS
SANITIZERS
OPERATIONAL SUPPLIES AND APPLICATIONS
Subparts
252
taken from bulk
07.10.13
1
7-201
Storage
2
7-202
Presence and Use
3
7-203
Container Prohibitions
4
7-204
Chemicals
5
7-205
Lubricants
6
7-206
Pesticides
7
7-207
Medicines
8
7-208
First Aid Supplies
9
7-209
Other Personal Care Items
7-201.11
Separation.*
10
11
Storage
12
POISONOUS
13
contaminate FOOD, EQUIPMENT, UTENSILS, LINENS, and SINGLE-SERVICE
14
and SINGLE-USE ARTICLES by:
15
(A)
Separating the
shall be stored so they can not
POISONOUS OR TOXIC MATERIALS
by spacing or
partitioning;S and
16
17
OR TOXIC MATERIALS
(B)
Locating the
POISONOUS OR TOXIC MATERIALS
in an area
18
that is not above
19
SINGLE-SERVICE
20
not apply
21
SANITIZERS that are stored in WAREWASHING areas for availability
22
and convenience if the materials are stored to prevent
23
contamination of
to
FOOD, EQUIPMENT, UTENSILS, LINENS,
and
or SINGLE-USE ARTICLES. This paragraph does
EQUIPMENT
and
UTENSIL
cleaners
FOOD, EQUIPMENT, UTENSILS, LINENS,
253
and
and
07.10.13
1
SINGLE-SERVICE
2
Presence and
7-202.11
3
Use
(A)
and
SINGLE-USE ARTICLES.
Restriction.*
Only those
POISONOUS
OR
TOXIC
MATERIALS
that are
4
required for the operation and maintenance of a
5
ESTABLISHMENT,
6
EQUIPMENT
7
rodents, shall be allowed in a
8
(B)
9
such as for the cleaning and
and
UTENSILS
SANITIZING
POISONOUS OR TOXIC MATERIALS
7-202.12
11
POISONOUS
12
(A)
of
and the control of insects and
FOOD ESTABLISHMENT.
Paragraph (A) of this section does not apply to
10
FOOD
S
PACKAGED
that are for retail sale.
Conditions of Use.*
OR TOXIC MATERIALS
shall be:
Used according to:
13
(1)
LAW and this Code,
14
(2)
Manufacturer's use directions included in labeling, and,
15
for a pesticide, manufacturer's label instructions that
16
state that use is allowed in a
17
(3)
18
(4)
20
22
23
The conditions of certification, if certification is required,
for use of the pest control materials, and
19
21
FOOD ESTABLISHMENT,
Additional conditions that may be established by the
REGULATORY AUTHORITY;
(B)
and
Applied so that:
(1)
A
HAZARD
to
EMPLOYEES
constituted, and
254
or other
PERSONS
is not
1
(2)
07.10.13
Contamination including toxic residues due to drip,
2
drain, fog, splash or spray on
3
UTENSILS, LINENS,
4
ARTICLES
is prevented, and for a
5
PESTICIDE,
this is achieved by:
6
(a)
Removing the items,
7
(b)
Covering the items with impermeable covers,
8
and
FOOD, EQUIPMENT,
SINGLE-SERVICE
and
SINGLE-USE
RESTRICTED USE
or
9
(c)
10
Taking other appropriate preventive actions,
and
11
(d)
12
Cleaning and SANITIZING EQUIPMENT and UTENSILS
after the application.
13
C)
A
RESTRICTED USE PESTICIDE
shall be applied only by an
14
applicator certified as defined in 7 USC 136 Definitions, (e)
15
Certified Applicator, of the Federal Insecticide, Fungicide,
16
and Rodenticide Act, or a PERSON under the direct supervision
17
of a certified applicator.
18
Container
7-203.11
19
Prohibitions
A container previously used to store
20
21
Poisonous or Toxic Material Containers.*
POISONOUS OR TOXIC MATERIALS
may not be used to store, transport, or dispense FOOD.
Chemicals
7-204.11
Sanitizers, Criteria.*
22
Chemical
23
FOOD-CONTACT SURFACEs
SANITIZERS
and other chemical antimicrobials applied to
255
shall meet the requirements specified in
1
07.10.13
40 CFR 180.940 Tolerance exemptions for active and inert ingredients
2
for use in antimicrobial formulations (food-contact surface sanitizing
3
solutions).
4
7-204.12
5
Chemicals for Washing Fruits and Vegetables,
Criteria.*
6
Chemicals used to wash or peel raw, whole fruits and vegetables
7
shall meet the requirements specified in 21 CFR 173.315 Chemicals
8
used in washing or to assist in the peeling of fruits and vegetables.
9
7-204.13
Boiler Water Additives, Criteria.*
10
Chemicals used
as boiler water
11
requirements specified in 21 CFR 173.310 Boiler water additives.
12
7-204.14
13
Drying agents used in conjunction with SANITIZATION shall:
14
(A)
ADDITIVES
shall meet the
Drying Agents, Criteria.*
Contain only components that are listed as one of the
15
following:
16
(1)
Generally recognized as safe for use in
FOOD
as
17
specified in 21 CFR 182 - Substances Generally
18
Recognized as Safe, or 21 CFR 184 - Direct Food
19
Substances Affirmed as Generally Recognized as Safe,
20
(2)
Generally recognized as safe for the intended use
21
as
22
Substances Affirmed as Generally Recognized as Safe,
23
(3)
specified
in
21 CFR 186 - Indirect Food
APPROVED for use as a drying agent under a prior
256
1
07.10.13
sanction specified in 21 CFR 181 - Prior-Sanctioned
2
Food Ingredients,
(4)
3
Specifically regulated as an indirect
FOOD ADDITIVE
4
for use as a drying agent as specified in 21 CFR
5
Parts 175-178, or
(5)
6
APPROVED
for use as a drying agent under the
7
threshold of regulation process established by 21
8
CFR 170.39 Threshold of regulation for substances
9
used in food-contact articles; and
10
(B)
When
SANITIZATION
is with chemicals, the approval required
11
under Subparagraph (A)(3) or (A)(5) of this section or the
12
regulation as an indirect
13
Subparagraph (A)(4) of this section, shall be specifically for use
14
with chemical SANITIZING solutions.
15
Lubricants
7-205.11
FOOD ADDITIVE
required under
Incidental Food Contact, Criteria.*
16
Lubricants shall meet
17
178.3570 Lubricants with incidental food contact, if they are used
18
on
19
within
20
located so that lubricants may leak, drip, or be forced into
21
onto
22
23
Pesticides
the
FOOD-CONTACT SURFACES,
requirements specified in 21 CFR
on bearings and gears located on or
FOOD-CONTACT SURFACES,
or on bearings and gears that are
FOOD
or
FOOD-CONTACT SURFACES.
7-206.11
Restricted Use Pesticides, Criteria.*
RESTRICTED USE PESTICIDES specified under ¶ 7-202.12(C) shall meet
257
1
07.10.13
the requirements specified in 40 CFR 152 Subpart I - Classification
2
of Pesticides.
3
7-206.12
4
Rodent bait shall be contained in a covered, tamper-resistant bait
5
station.
6
7-206.13
7
(A)
Rodent Bait Stations.*
Tracking Powders, Pest Control and Monitoring.*
Except as specified in ¶ (B) of this section, a tracking powder
pesticide may not be used in a
8
9
(B)
If used, a nontoxic tracking powder such as talcum or flour may
10
not contaminate
11
SINGLE-SERVICE
12
13
Medicines
7-207.11
(A)
FOOD ESTABLISHMENT.
FOOD, EQUIPMENT, UTENSILS, LINENS,
and
SINGLE-USE ARTICLES.
and
N
Restriction and Storage.*
Except for medicines that are stored or displayed for retail
14
sale, only those medicines that are necessary for the
15
health
16
ESTABLISHMENT.
17
(B)
of
Medicines
EMPLOYEES
shall be allowed in a
that are in a
use
FOOD ESTABLISHMENT
for the
18
EMPLOYEES'
19
7-101.11 and located to prevent the contamination of
20
EQUIPMENT, UTENSILS, LINENS,
21
USE ARTICLES.
22
7-207.12
23
Medicines belonging to
FOOD
shall be labeled as specified under §
FOOD,
and SINGLE-SERVICE and SINGLE-
Refrigerated Medicines, Storage.*
258
EMPLOYEES
or to children in a day care
1
center
that
require
2
refrigerator shall be:
3
(A)
refrigeration
07.10.13
and are stored in a FOOD
Stored in a package or container and kept inside a
4
covered,
5
container for the storage of medicines; and
6
(B)
leakproof
container that
identified
as
a
Located so they are inaccessible to children.
7
First Aid
7-208.11
8
Supplies
First aid
supplies that are in a
EMPLOYEES'
use shall be:
9
is
Storage.*
FOOD ESTABLISHMENT
for the
10
(A)
Labeled as specified under § 7-101.11;S and
11
(B)
Stored in a kit or a container that is located to prevent the
12
contamination of FOOD, EQUIPMENT, UTENSILS, and LINENS, and
13
SINGLE-SERVICE
and
SINGLE-USE ARTICLES.
S
14
Other Personal
7-209.11
Storage.
15
Care Items
Except as specified under §§ 7-207.12 and 7-208.11,
16
shall store their
17
¶ 6-305.11(B).
18
7-3
19
PERSONAL CARE ITEMS
EMPLOYEES
in facilities as specified under
STOCK AND RETAIL SALE
Subpart
20
7-301
Storage and Display
Separation.*
21
22
Storage and
7-301.11
23
Display
POISONOUS or
TOXIC MATERIALS
259
shall be stored and displayed for
07.10.13
1
retail sale so they can not contaminate
2
LINENS,
3
(A)
Separating the
SINGLE-USE ARTICLES
POISONOUS
or
TOXIC MATERIALS
by:
by spacing or
partitioning;S and
4
5
and SINGLE-SERVICE and
FOOD, EQUIPMENT, UTENSILS,
(B)
Locating the
POISONOUS OR TOXIC MATERIALS
in an area
6
that is not above
FOOD, EQUIPMENT, UTENSILS, LINENS,
7
SINGLE-SERVICE
SINGLE-USE ARTICLES.
or
8
9
10
11
12
13
14
15
16
17
18
19
260
and
07.10.13
1
2
3
INTENTIONALLY LEFT BLANK
4
5
6
7
8
261
07.10.13
1
Chapter
2
6
3
Parts
4
6-1
MATERIALS FOR CONSTRUCTION AND REPAIR
5
6-2
DESIGN, CONSTRUCTION, AND INSTALLATION
6
6-3
NUMBERS AND CAPACITIES
7
6-4
LOCATION AND PLACEMENT
8
6-5
MAINTENANCE AND OPERATION
6-1
MATERIALS FOR CONSTRUCTION AND REPAIR
Physical Facilities
9
10
11
Subparts
12
6-101
Indoor Areas
13
6-102
Outdoor Areas
6-101.11
Surface Characteristics.
14
15
16
Indoor Areas
(A)
Except as specified in ¶ (B) of this section, materials for
17
indoor floor, wall, and ceiling surfaces under conditions of
18
normal use shall be:
19
(1)
20
21
22
SMOOTH, durable, and
where
(2)
EASILY CLEANABLE
FOOD ESTABLISHMENT operations
Closely woven and
carpeted areas; and
230
for areas
are conducted;
EASILY CLEANABLE
carpet for
1
(3)
07.10.13
Non absorbent for areas subject to moisture such as
2
FOOD
3
WAREWASHING
4
ESTABLISHMENT SERVICING AREAS,
5
to flushing or spray cleaning methods.
6
(B)
7
preparation
areas,
walk-in
refrigerators,
areas, toilet rooms, mobile
FOOD
and areas subject
In a TEMPORARY FOOD ESTABLISHMENT:
(1)
If graded to drain, a floor may be concrete, machine-
8
laid asphalt, or dirt or gravel if it is covered with
9
mats, removable platforms, duckboards, or other
10
APPROVED
11
control dust and mud; and
12
(2)
materials that are effectively treated to
Walls and ceilings may be constructed of a material
13
that
14
windblown dust and debris.
15
16
Outdoor Areas
6-102.11
(A)
protects
the interior
from the weather and
Surface Characteristics.
The outdoor walking and driving areas shall be surfaced
17
with concrete, asphalt, or gravel or other materials that
18
have been effectively treated to minimize dust, facilitate
19
maintenance, and prevent muddy conditions.
20
(B)
Exterior surfaces of buildings and mobile FOOD ESTABLISHMENTS
21
shall be of weather-resistant materials and shall comply
22
with
23
(C)
LAW.
Outdoor storage areas
231
for
REFUSE,
recyclables, or
1
07.10.13
returnables shall be of materials specified under §§ 5-501.11
2
and 5-501.12.
3
4
6-2
5
DESIGN, CONSTRUCTION, AND INSTALLATION
Subparts
6
6-201
Cleanability
7
6-202
Functionality
6-201.11
Floors, Walls, and Ceilings.
8
Cleanability
9
Except as specified under § 6-201.14 and except for antislip
10
floor coverings or applications that may be used for safety reasons,
11
floors, floor coverings, walls, wall coverings, and ceilings shall
12
designed, constructed, and installed so they are
13
EASILY CLEANABLE.
14
6-201.12
15
(A)
16
17
SMOOTH
be
and
Floors, Walls, and Ceilings, Utility Lines.
Utility service lines and pipes may not be unnecessarily
exposed
(B)
Exposed utility service lines and pipes shall be installed so
18
they do not obstruct or prevent cleaning of the floors, walls,
19
or ceilings.
20
21
22
23
(C)
Exposed horizontal utility service lines and pipes may not
be installed on the floor.
6-201.13
Floor and Wall Junctures, Coved, and Enclosed
or Sealed.
232
1
(A)
In
FOOD ESTABLISHMENTS
07.10.13
in which cleaning methods other
2
than water flushing are used for cleaning floors, the floor
3
and wall junctures shall be coved and closed
4
larger than 1 mm (one thirty-second inch).
5
(B)
The floors in
FOOD ESTABLISHMENTS
to no
in which water flush
6
cleaning methods are used shall be provided with drains and
7
be graded to drain, and the floor and wall junctures shall
8
be coved and
9
10
6-201.14
(A)
SEALED.
Floor Carpeting, Restrictions and Installation.
A floor covering such as carpeting
11
may
12
preparation areas, walk-in refrigerators,
13
toilet room areas where handwashing lavatories, toilets,
14
and urinals are located, REFUSE storage rooms, or other areas
15
where the floor is subject to moisture, flushing, or spray
16
cleaning methods.
17
(B)
not
be
installed
as a
or similar material
floor covering
in
FOOD
WAREWASHING areas,
If carpeting is installed as a floor covering in areas other
18
than those specified under ¶ (A) of this section, it shall
19
be:
20
(1)
Securely attached to the floor with a durable mastic,
21
by using a stretch and tack method, or by another
22
method; and
23
(2)
Installed tightly against the wall under the coving or
233
1
07.10.13
installed away from the wall with a space between the
2
carpet and the wall and with the edges of the
3
carpet secured by metal stripping
4
means.
or some other
5
6-201.15
6
Mats and duckboards shall be designed to be removable and EASILY
7
CLEANABLE.
8
6-201.16
9
(A)
10
11
Floor Covering, Mats and Duckboards.
Wall and Ceiling Coverings and Coatings.
Wall and ceiling covering materials shall be attached so
that they are
(B)
EASILY CLEANABLE.
Except in areas used only for dry storage, concrete,
12
porous blocks, or bricks used for indoor wall construction
13
shall be finished and
14
nonabsorbent,
15
6-201.17
16
(A)
SEALED
EASILY CLEANABLE
to provide a
SMOOTH,
surface.
Walls and Ceilings, Attachments.
Except as specified in ¶ (B) of this section, attachments
17
to walls and ceilings such as light fixtures, mechanical
18
room ventilation system components, vent covers, wall
19
mounted fans, decorative items, and other attachments
20
shall be
21
(B)
In
a
EASILY CLEANABLE.
CONSUMER
area, wall and ceiling surfaces and
22
decorative items and attachments that are provided for
23
ambiance need not meet this requirement if they are kept
234
07.10.13
1
clean.
2
6-201.18
3
Except for
4
rafters may not be exposed in areas subject to moisture.
5
6
Functionality
6-202.11
(A)
Walls and Ceilings, Studs, Joists, and Rafters.
TEMPORARY FOOD ESTABLISHMENTS,
studs, joists, and
Light Bulbs, Protective Shielding.
Except as specified in ¶ (B) of this section, light bulbs
7
shall be shielded, coated, or otherwise shatter-resistant in
8
areas where there is exposed
9
UTENSILS,
10
11
and
LINENS;
FOOD;
or unwrapped
clean
EQUIPMENT,
SINGLE-SERVICE
and
SINGLE-USE ARTICLES.
(B)
Shielded, coated, or otherwise shatter-resistant bulbs need
12
not be used
13
unopened packages, if:
14
(1)
15
in
areas
used
only
for storing
FOOD
in
The integrity of the packages cannot be affected by
broken glass falling onto them; and
16
(2)
17
The packages are capable of being cleaned of debris
from broken bulbs before the packages are opened.
18
19
(C)
An infrared or other heat lamp shall be protected against
20
breakage by a shield surrounding and extending beyond
21
the bulb so that only the face of the bulb is exposed.
22
23
6-202.12
Heating,
Vents.
235
Ventilating, Air Conditioning System
1
07.10.13
Heating, ventilating, and air conditioning systems shall be designed
2
and installed so that make-up air intake and exhaust vents do
3
not cause
4
EQUIPMENT,
5
6-202.13
6
(A)
contamination of
or
FOOD, FOOD-CONTACT SURFACES,
UTENSILS.
Insect Control Devices, Design and Installation.
Insect control devices that are used to electrocute or stun flying
7
insects shall be designed to retain the insect within the
8
device.
9
(B)
10
Insect control devices shall be installed so that:
(1)
11
The devices are not located over a
FOOD preparation
area; and
12
(2)
Dead insects and insect fragments are prevented
13
from being impelled onto or falling on exposed
14
FOOD;
15
unwrapped
clean
EQUIPMENT, UTENSILS,
SINGLE-SERVICE
and
and
LINENS;
and
SINGLE-USE ARTICLES.
16
6-202.14
Toilet Rooms, Enclosed.
17
Except where a toilet room is located outside a
18
and does not open directly into the
19
toilet room that is provided by the management of a shopping mall, a
20
toilet room located on the
21
and provided with a tight-fitting and self-closing door.
22
6-202.15
23
(A)
PREMISES
FOOD ESTABLISHMENT
FOOD ESTABLISHMENT
such as a
shall be completely enclosed
Outer Openings, Protected.
Except as specified in ¶¶ (B), (C), and (E) and under ¶
236
07.10.13
1
(D) of
2
ESTABLISHMENT
3
insects and rodents by:
4
(1)
5
this
section,
outer
openings
a
FOOD
shall be protected against the entry of
Filling or closing holes and other gaps along floors,
walls, and ceilings;
6
(2)
Closed, tight-fitting windows; and
7
(3)
Solid, self-closing, tight-fitting doors.
8
of
(B)
9
Paragraph (A) of this section does not apply if a
ESTABLISHMENT
FOOD
opens into a larger structure, such as a
10
mall, airport, or office building, or into an attached structure,
11
such as a porch, and the outer openings from the larger
12
or attached structure are protected against the entry of
13
insects and rodents.
14
(C)
Exterior doors used as exits need not be self-closing if
15
they are:
16
(1)
Solid and tight-fitting;
17
(2)
Designated for use only when an emergency exists,
18
by the fire protection authority that has jurisdiction
19
over the
20
(3)
FOOD ESTABLISHMENT;
and
Limited-use so they are not used for entrance or
21
exit from the building for purposes other than the
22
designated emergency exit use.
23
24
(D)
Except as specified in ¶¶ (B) and (E) of this section, if the
windows or doors of a
237
FOOD ESTABLISHMENT,
or of a
larger
2
located, are kept open for ventilation or other purposes or
3
a
4
windows
5
section, the openings shall
6
entry of insects and rodents by:
7
(1)
16 mesh to 25.4 mm (16 mesh to 1 inch) screens;
8
(2)
Properly designed and installed air curtains to control
13
which a
ESTABLISHMENT
FOOD ESTABLISHMENT
is not provided with
and doors as specified under ¶ (A) of this
be protected
against the
flying insects; or
10
12
within
TEMPORARY FOOD
9
11
structure
07.10.13
is
1
(3)
(E)
Other effective means.
Paragraph (D) of this section does not apply if flying insects
and other pests are absent due to the location of the
ESTABLISHMENT,
the weather, or other limiting condition.
14
6-202.16
Exterior Walls and Roofs, Protective Barrier.
15
Perimeter walls and roofs of a FOOD ESTABLISHMENT shall effectively
16
protect the establishment from the weather and the entry of
17
insects, rodents, and other animals.
18
6-202.17
19
Except for machines
20
outside, a machine used to vend
21
overhead protection.
22
6-202.18
23
Except for areas used only for the loading of water or the discharge
Outdoor Food Vending Areas, Overhead Protection.
that
vend
canned
FOOD
BEVERAGES,
if located
shall be provided with
Outdoor Servicing Areas, Overhead Protection.
238
07.10.13
and other liquid waste, through the use of a closed
1
of
2
system of hoses,
3
overhead protection.
4
6-202.19
SEWAGE
SERVICING
AREAS
shall be provided with
Outdoor Walking and Driving Surfaces, Graded
5
to Drain.
6
Exterior walking and driving surfaces shall be graded to drain.
7
6-202.110
Outdoor Refuse Areas, Curbed and Graded to
8
9
Drain.
areas
shall
be constructed in
accordance
Outdoor
REFUSE
10
with
and shall be curbed and graded to drain to collect
11
and dispose of liquid waste that results from the
12
from cleaning the area and waste receptacles.
13
6-202.111
LAW
14
REFUSE
and
Private Homes and Living or Sleeping Quarters,
Use Prohibition.
15
A private home, a room used as living or sleeping quarters, or
16
an area directly opening into a room used as living or sleeping
17
quarters shall not be used for conducting
18
operations.
19
6-202.112
FOOD ESTABLISHMENT
Living or Sleeping Quarters, Separation.
239
07.10.13
of a FOOD
1
Living or sleeping quarters located on the
2
ESTABLISHMENT
3
clerks or resident managers shall be separated from rooms and
4
areas used for
5
partitioning and solid self-closing doors.
PREMISES
such as those provided for lodging registration
FOOD ESTABLISHMENT
operations by complete
6
7
6-3
8
NUMBERS AND CAPACITIES
Subparts
9
6-301
Handwashing Sinks
10
6-302
Toilets and Urinals
11
6-303
Lighting
12
6-304
Ventilation
13
6-305
Dressing Areas and Lockers
14
6-306
Service Sinks
Minimum Number.
15
16
Handwashing
6-301.10
17
Sinks
HANDWASHING
SINKS
shall
be
provided
as specified under
18
§ 5-203.11.
19
6-301.11
20
Each
HANDWASHING SINK
21
SINKS
shall be provided with a supply of hand cleaning liquid
22
or powder soap.
23
6-301.12
Handwashing Cleanser, Availability.
or group of 2 adjacent
Hand Drying Provision.
240
HANDWASHING
07.10.13
1
Each
2
shall be provided with:
3
(A)
Individual, disposable towels;
4
(B)
A continuous towel system that supplies the user with a
HANDWASHING SINK
5
or group of adjacent
HANDWASHING SINKS
clean towel; or
6
(C)
A heated-air hand drying device.
7
6-301.13
8
A sink used for
9
service sink or curbed cleaning facility used for the disposal of
Handwashing Aids and Devices, Use Restrictions.
FOOD
preparation or
UTENSIL
washing, or a
10
mop water or similar wastes,
11
handwashing aids and devices required for a
12
as specified under §§ 6-301.11 and 6-301.12 and ¶ 5-501.16(C).
13
6-301.14
14
A sign or poster that notifies
FOOD EMPLOYEES
15
hands shall be provided at all
HANDWASHING SINKS
16
EMPLOYEES
17
6-301.20
18
A
19
that is provided with disposable towels shall be provided with a
20
waste receptacle as specified under ¶ 5-501.16(C).
Toilets and
6-302.10
22
Urinals
Toilets
23
HANDWASHING SINK
Handwashing Signage.
and shall be clearly visible to
to wash their
used by
FOOD
FOOD EMPLOYEES.
Disposable Towels, Waste Receptacle.
HANDWASHING SINK
21
shall not be provided with the
or group of adjacent
HANDWASHING SINKS
Minimum Number.
and
urinals
shall
§ 5-203.12
241
be
provided
as
specified under
07.10.13
1
6-302.11
2
A supply of toilet tissue shall be available at each toilet and
3
shall be provided to the user in a manner that minimizes its
4
contamination
5
contamination.
6
Lighting
6-303.11
Toilet Tissue, Availability.
from
dust,
and
The light intensity shall be:
8
(A)
types
of
At least 108 lux (10 foot candles) at a distance of 75 cm
(30 inches) above the floor, in walk-in refrigeration units
10
and dry
11
rooms during periods of cleaning;
12
other
Intensity.
7
9
water,
(B)
13
FOOD
storage areas and in other areas and
At least 215 lux (20 foot candles):
(1)
At a surface where
FOOD
is provided for
CONSUMER
14
self-service such as buffets and salad bars or
15
where fresh produce or
16
or offered for consumption,
17
(2)
18
Inside
EQUIPMENT
PACKAGED FOODS
such as reach-in and under-
counter refrigerators; and
19
(3)
At a distance of 75 cm (30 inches) above the floor
20
in areas used for handwashing,
21
EQUIPMENT
22
and
23
are sold
(C)
and
UTENSIL
WAREWASHING,
and
storage, and in toilet rooms;
At least 540 lux (50 foot candles) at a surface where a
242
1
FOOD EMPLOYEE
2
UTENSILS
3
or saws where
4
Ventilation
6-304.11
or
is working with
EQUIPMENT
FOOD
07.10.13
or working with
such as knives, slicers, grinders,
EMPLOYEE
safety is a factor.
Mechanical.
5
If necessary to keep rooms free of excessive heat, steam,
6
condensation, vapors, obnoxious odors, smoke, and fumes,
7
mechanical ventilation of sufficient capacity shall be provided.
8
Dressing Areas
6-305.11
9
and
(A)
10
Lockers
Designation.
Dressing rooms or dressing areas shall be designated
if EMPLOYEES routinely change their clothes in the
11
establishment.
12
(B)
Lockers or other suitable facilities shall be provided for the
13
orderly
14
possessions.
15
Service Sinks
6-306.10
storage
of
EMPLOYEES'
clothing and other
Availability.
16
A service sink or curbed cleaning facility shall be provided as specified
17
under § 5-203.13.
18
19
20
6-4
LOCATION AND PLACEMENT
Subparts
21
6-401
Handwashing Sinks
22
6-402
Toilet Rooms
23
6-403
Employee Accommodations
243
07.10.13
1
6-404
Distressed Merchandise
2
6-405
Refuse, Recyclables, and Returnables
Conveniently Located.
3
4
Handwashing
6-401.10
5
Sinks
HANDWASHING
6
7
SINKS
shall be conveniently located as specified
under § 5-204.11.
Toilet Rooms
6-402.11
Convenience and Accessibility.
8
Toilet rooms shall be conveniently located and accessible to
9
EMPLOYEES
10
Employee
6-403.11
11
Accommodations (A)
12
during all hours of operation.
Designated Areas.
Areas designated for EMPLOYEES to eat, drink, and use tobacco
shall be located so that
13
SERVICE
14
contamination.
15
(B)
and
FOOD, EQUIPMENT, LINENS, and SINGLE-
SINGLE-USE ARTICLES
are
protected from
Lockers or other suitable facilities shall be located in a
16
designated
17
EQUIPMENT, UTENSILS, LINENS,
18
USE ARTICLES
19
Distressed
6-404.11
20
Merchandise
Products
room or area where contamination of
FOOD,
and SINGLE-SERVICE and SINGLE-
cannot occur.
Segregation and Location.
that
are
held
by
the
PERMIT HOLDER
for credit,
21
redemption, or return to the distributor, such as damaged,
22
spoiled, or recalled products, shall be segregated and held in
23
designated areas that are separated from
244
FOOD, EQUIPMENT,
07.10.13
1
UTENSILS, LINENS,
6-405.10
and
SINGLE-SERVICE
Waste
SINGLE-USE ARTICLES.
2
Refuse,
3
Recyclables,
4
and
Units,
receptacles,
5
Returnables
REFUSE
and recyclable and returnable containers shall be
6
Receptacles,
and
Handling
Units,
and
Designated Storage Areas.
and
areas designated for storage of
located under as specified § 5-501.19.
7
8
6-5
9
MAINTENANCE AND OPERATION
Subpart
10
6-501 Premises, Structures, Attachments, and Fixtures– Methods
11
Premises,
6-501.11
12
Structures,
PHYSICAL
13
Attachments,
14
and Fixtures
15
- Methods
16
6-501.12
17
(A)
18
19
Repairing.
FACILITIES
shall be maintained in good repair.
Cleaning, Frequency and Restrictions.
PHYSICAL
FACILITIES
shall
be
cleaned
as
often
as
necessary to keep them clean.
(B)
Except for cleaning that is necessary due to a spill or
20
other accident, cleaning shall be done during periods
21
when the least amount
22
after closing.
23
6-501.13
of
FOOD
is exposed such as
Cleaning Floors, Dustless Methods.
245
1
(A)
Except
as specified
in ¶ (B) of
07.10.13
this section, only
2
dustless methods of cleaning shall be used, such as wet
3
cleaning, vacuum cleaning, mopping with treated dust mops,
4
or sweeping using a broom and dust-arresting compounds.
5
6
(B)
Spills or drippage on floors that occur between normal
7
floor cleaning times may be cleaned:
8
(1)
Without the use of dust-arresting compounds; and
9
(2)
In the case of liquid spills or drippage, with the use
10
of a small amount of absorbent compound such as
11
sawdust or diatomaceous earth applied immediately
12
before spot cleaning.
13
6-501.14
14
15
Cleaning
Ventilation
Systems,
Nuisance
and
Discharge Prohibition.
(A)
Intake and exhaust air ducts shall be cleaned and filters
16
changed so they are not a source of contamination by
17
dust, dirt, and other materials.
18
(B)
If vented to the outside, ventilation systems shall not
19
create a public health
20
discharge.
21
22
23
6-501.15
Cleaning
HAZARD
Maintenance
or nuisance or unLAWful
Tools,
Preventing
Contamination.*
FOOD preparation sinks,
246
HANDWASHING SINKS,
and
WAREWASHING
1
EQUIPMENT
07.10.13
shall not be used for the cleaning of maintenance tools,
2
the preparation or holding of maintenance materials, or the
3
disposal of mop water and similar liquid wastes.
4
6-501.16
5
After use, mops shall be placed in a position that allows them
6
to air-dry without soiling walls,
7
6-501.17
8
Except as specified in ¶ 6-501.13(B), sawdust, wood shavings,
9
granular salt, baked clay, diatomaceous earth, or similar materials
10
Drying Mops.
EQUIPMENT,
or supplies.
Absorbent Materials on Floors, Use Limitation.
shall not be used on floors.
11
6-501.18
Cleaning of Plumbing Fixtures.
12
PLUMBING
13
shall be cleaned as often as necessary to keep them clean and
14
maintained and used as specified under § 5-205.11.
15
6-501.19
16
Except during cleaning and maintenance operations, toilet room
17
doors as specified under § 6-202.14 shall be kept closed.
18
6-501.110
19
(A)
FIXTURES
such as
Closing Toilet Room Doors.
Using Dressing Rooms and Lockers.
Dressing rooms shall be used by
20
EMPLOYEES
21
establishment.
22
23
(B)
HANDWASHING SINKS, toilets, and urinals
regularly
change
their
EMPLOYEES
clothes
if the
in
the
Lockers or other suitable facilities shall be used for the
orderly storage
247
of
EMPLOYEE
clothing
and
other
07.10.13
1
possessions.
2
6-501.111
Controlling Pests.*
3
The presence of insects, rodents, and other pests shall be controlled
4
to minimize their presence on the
5
(A)
PREMISES
by:
Routinely inspecting incoming shipments of
FOOD
and
supplies;N
6
for evidence of pests;N
7
(B)
Routinely inspecting the
8
(C)
Using methods, if pests are found, such as trapping
9
devices
10
PREMISES
or other means of pest control as specified
under §§ 7-202.12, 7-206.12, and 7-206.13; and
Eliminating harborage conditions.N
11
(D)
12
6-501.112
13
Removing
Dead or Trapped Birds, Insects,
Rodents, and Other Pests.
14
Dead or trapped birds, insects, rodents, and other pests shall
15
be
16
frequency that
17
the attraction of pests.
18
6-501.113
19
Maintenance tools such
20
and similar items shall be:
21
(A)
22
23
removed
control devices and
the
PREMISES
at
a
prevents their accumulation, decomposition, or
Storing Maintenance Tools.
as brooms, mops, vacuum cleaners,
Stored so they do not contaminate FOOD, EQUIPMENT, UTENSILS,
LINENS,
(B)
from
and SINGLE-SERVICE and SINGLE-USE
ARTICLES;
and
Stored in an orderly manner that facilitates cleaning the
248
07.10.13
1
2
area used for storing the maintenance tools.
6-501.114.1.1
Maintaining Premises, Unnecessary Items
3
and Litter.
4
The
PREMISES
5
(A)
Items
shall be free of:
that
are
unnecessary to the
operation
6
maintenance of the
7
that is nonfunctional or no longer used; and
8
(B)
9
6-501.115
10
(A)
establishment such as
Prohibiting Animals.*
Except as specified in ¶¶ (B) and (C) of this section, live
animals shall not be allowed on the
12
ESTABLISHMENT.
(B)
the contamination of
15
and
17
PREMISES
of a
FOOD
Live animals may be allowed in the following situations if
14
16
EQUIPMENT
Litter.
11
13
or
LINENS;
ARTICLES
(1)
FOOD;
and unwrapped
clean
EQUIPMENT, UTENSILS,
SINGLE-SERVICE
and
SINGLE-USE
in
aquariums,
cannot result.
Edible
FISH
or
decorative
FISH
18
shellfish or crustacea on ice or under refrigeration,
19
and shellfish and crustacea in display tank systems;
20
(2)
Patrol
dogs
accompanying
police
or
security
21
officers in offices and dining, sales,
22
areas, and sentry dogs running loose in outside
23
fenced areas;
249
and storage
1
(3)
In areas that are not used for
FOOD
07.10.13
preparation
2
and that are usually open for customers, such as
3
dining
4
controlled by the disabled
EMPLOYEE
5
health or safety
will
6
presence or activities of the
7
(4)
and sales areas,
HAZARD
SERVICE ANIMALS
or
that are
PERSON,
if a
not result from the
SERVICE ANIMAL;
Pets in the common dining areas of institutional
8
care facilities such as nursing homes, assisted
9
living
facilities, group homes, or residential care
10
facilities at times other than during meals if:
11
(a)
Effective partitioning and self-closing doors
12
separate
13
FOOD
14
(b)
the common dining areas from
storage or
Condiments,
FOOD
preparation areas,
EQUIPMENT,
and
UTENSILS
are
15
stored in enclosed cabinets or removed from
16
the
17
present, and
18
(c)
common dining areas when pets are
Dining areas including tables, countertops,
19
and similar surfaces are effectively cleaned
20
before the next meal service; and
21
(5)
In areas that are not used for FOOD preparation, storage,
22
sales, display, or dining, in which there are caged
23
animals or animals that are similarly confined, such as
24
in a variety store that sells pets or a tourist park
250
07.10.13
1
2
3
4
that displays animals.
(C)
Live or dead
FOOD;
clean
FISH
bait may be stored if contamination of
EQUIPMENT, UTENSILS, and LINENS; and unwrapped
SINGLE-SERVICE
and
251
SINGLE-USE ARTICLES
cannot result.
07.10.13
1
Chapter
2
5
3
Parts
Water, Plumbing, and Waste
4
5-1
WATER
5
5-2
PLUMBING SYSTEM
6
5-3
MOBILE WATER TANK AND MOBILE FOOD ESTABLISHMENT WATER
7
TANK
8
5-4
SEWAGE, OTHER LIQUID WASTE, AND RAINWATER
9
5-5
REFUSE, RECYCLABLES, AND RETURNABLES
5-1
WATER
10
11
12
Subparts
13
5-101
Source
14
5-102
Quality
15
5-103
Quantity and Availability
16
5-104
Distribution, Delivery, and Retention
5-101.11
Approved System.*
17
18
Source
19
DRINKING
20
is:
21
(A)
A
22
(B)
A nonpublic
WATER
shall be obtained from an
PUBLIC WATER SYSTEM;
source that
or
WATER SYSTEM
206
APPROVED
that is constructed, maintained,
07.10.13
and operated according to LAW.
1
2
5-101.12
3
A DRINKING WATER system shall be flushed and disinfected before being
4
placed in service after construction, repair, or modification and after
5
an
6
contaminants to the system.
7
5-101.13
8
BOTTLED DRINKING WATER used or sold in a
9
be obtained from
10
11
System Flushing and Disinfection.*
emergency
situation,
such
Bottled Drinking Water.*
APPROVED
5-102.11
FOOD ESTABLISHMENT
DRINKING WATER.
Standards.*
12
Except as specified under § 5-102.12:
13
(A)
Water from a
shall
PUBLIC WATER SYSTEM
meet 40 CF141 -
14
National Primary Drinking Water Regulations and state
15
WATER
16
(B)
17
WATER
5-102.12
19
(A)
20
21
DRINKING
quality standards; and
Water from a nonPUBLIC
18
shall
sources in accordance with 21 CFR 129 -
Processing and Bottling of Bottled
Quality
as a flood, that may introduce
WATER SYSTEM
shall meet state
DRINKING
quality standards.
Nondrinking Water.*
A nonDRINKING WATER supply shall be used only if its use is
APPROVED.
(B)
NonDRINKING
WATER
shall
be
used
only
22
purposes such as air conditioning, nonFOOD
23
fire protection, and irrigation.
207
for
nonculinary
EQUIPMENT
cooling,
07.10.13
1
5-102.13
2
Except when used as specified under §5-102.12, water from a nonPUBLIC
3
WATER SYSTEM
4
required by state water quality regulations.
5
5-102.14
6
The most recent sample report for the nonpublic
7
be retained on file in the
8
maintained as specified by state water quality regulations.
9
10
Quantity and
5-103.11
Availability
(A)
11
Sampling.
shall be sampled and tested at least annually and as
Sample Report.
FOOD ESTABLISHMENT
(B)
13
shall
or the report shall be
Capacity.*
The water source and system shall be of sufficient capacity to
meet the peak water demands of the
12
WATER SYSTEM
Hot
water
generation
and
FOOD ESTABLISHMENT.
distribution
systems
shall
be
sufficient to meet the peak hot water demands throughout the
14
FOOD ESTABLISHMENT.
15
5-103.12
Pressure.
16
Water under pressure shall be provided to all fixtures,
17
non FOOD
18
supplied as specified under ¶¶ 5-104.12(A) and (B) to a TEMPORARY FOOD
19
ESTABLISHMENT
20
supply need not be under pressure.
EQUIPMENT
EQUIPMENT, and
that are required to use water except that water
or in response to a temporary interruption of a water
21
Distribution,
5-104.11
22
Delivery, and
Water shall be received from the source through the use of:
23
Retention
(A)
An
System.
APPROVED
public water main; or
208
1
(B)
07.10.13
One or more of the following that shall be constructed,
2
maintained, and operated according to
3
(1)
4
Nonpublic
water
main,
water
LAW:
pumps,
pipes, hoses,
connections, and other appurtenances,
5
(2)
Water transport vehicles, or
6
(3)
Water containers.
7
5-104.12
8
Water meeting the requirements specified under Subparts 5-101,
9
5-102, and 5-103 shall be made available for a mobile facility, for a
Alternative Water Supply.
10
TEMPORARY FOOD ESTABLISHMENT
without a permanent water supply,
11
and for a
with a temporary interruption of its
12
water supply through:
13
(A)
A supply of containers of commercially BOTTLED DRINKING WATER;
14
(B)
One or more closed portable water containers;
15
(C)
An enclosed vehicular water tank;
16
(D)
An on-PREMISES water storage tank; or
17
(E)
Piping, tubing, or hoses connected to an adjacent
18
19
20
FOOD ESTABLISHMENT
source.
5-2
PLUMBING SYSTEM
Subparts
21
5-201
Materials
22
5-202
Design, Construction, and Installation
23
5-203
Numbers and Capacities
209
APPROVED
07.10.13
1
5-204
Location and Placement
2
5-205
Operation and Maintenance
5-201.11
Approved.*
3
4
Materials
(A)
5
A
and hoses conveying water shall be
PLUMBING SYSTEM
6
constructed and repaired with
7
to
8
9
(B)
5-202.11
10
Construction,
(A)
11
and Installation
A
materials according
LAW.
A water filter shall be made of
Design,
12
APPROVED
SAFE MATERIALS.
Approved System and Cleanable Fixtures.*
shall be designed, constructed,
PLUMBING SYSTEM
and
installed according to LAW.
(B)
A
PLUMBING FIXTURE
urinal shall be
13
14
5-202.12
15
(A)
A
such as a
HANDWASHING SINK,
EASILY CLEANABLE.
toilet, or
N
Handwashing Sink, Installation.
HANDWASHING SINK
shall be equipped to provide water at a
16
temperature of at least 38oC (100oF) through a mixing valve
17
or combination faucet.
18
(B)
19
20
A steam mixing valve shall not be used at a
HANDWASHING
SINK.
(C)
A self-closing, slow-closing, or metering faucet shall provide
21
a flow of water for at least 15 seconds without the need to
22
reactivate the faucet.
23
(D)
An automatic handwashing facility shall be installed in accordance
210
07.10.13
1
with manufacturer’s instructions.
2
5-202.13
Backflow Prevention, Air Gap.*
3
An air gap between the water supply inlet and the flood level rim
4
of the
5
be at least twice the diameter of the water supply inlet and shall
6
not be less than 25 mm (1 inch).
7
5-202.14
8
A backflow or backsiphonage prevention device installed on a
9
water supply system shall meet American Society of Sanitary
PLUMBING FIXTURE, EQUIPMENT,
or nonFOOD
EQUIPMENT
shall
Backflow Prevention Device, Design Standard.
10
Engineering
11
maintenance, inspection, and testing for that specific application and
12
type of device.
13
5-202.15
14
A water filter, screen, and other water conditioning device installed on
15
water lines shall be designed to facilitate disassembly for periodic
16
servicing and cleaning. A water filter element shall be of the replaceable
17
type.
18
Numbers and
5-203.11
19
Capacities
(A)
(A.S.S.E.)
standards
for
construction,
installation,
Conditioning Device, Design.
Handwashing Sinks.*
Except as specified in ¶¶ (B) and (C) of this section, at least
20
1 HANDWASHING SINK, a number of HANDWASHING SINKS necessary
21
for their convenient use by EMPLOYEES in areas specified under
22
§ 5-204.11, and not fewer than the number of
23
SINKS required
by
LAW
211
shall be provided.
HANDWASHING
1
(B)
If
APPROVED
07.10.13
and capable of removing the types of soils
2
encountered in the
3
handwashing facilities may be substituted for
4
SINKS in a FOOD ESTABLISHMENT that has at least one HANDWASHING
5
SINK.
6
(C)
If
FOOD
operations involved, automatic
APPROVED, when FOOD exposure
is limited and HANDWASHING
7
SINKS
8
TEMPORARY FOOD ESTABLISHMENTS
9
LOCATIONS, EMPLOYEES may use chemically treated
10
HANDWASHING
are not conveniently available, such as in some mobile or
or at some
VENDING MACHINE
towelettes for
handwashing.
11
5-203.12
Toilets and Urinals.*
12
At least 1 toilet and not fewer than the toilets required by
13
shall be provided. If authorized by
14
for toilets, the substitution shall be done as specified in
15
5-203.13
16
At least 1 service sink or 1 curbed cleaning facility equipped with
17
a floor drain shall be provided and conveniently located for the
18
cleaning of mops or similar wet floor cleaning tools and for the
19
disposal of mop water and similar liquid waste.
20
5-203.14
21
A
22
solid, liquid, or gas contaminant into the water supply system at
23
each point of use at the
LAW
LAW
and urinals are substituted
LAW.
Service Sink.
Backflow Prevention Device, When Required.*
PLUMBING SYSTEM
shall be installed to preclude backflow of a
FOOD ESTABLISHMENT,
212
including on a hose
1
07.10.13
bibb if a hose is attached or on a hose bibb if a hose is not
2
attached and backflow prevention is required by
3
(A)
Providing an air gap as specified under § 5-202.13; or
4
(B)
Installing
5
an
APPROVED
backflow
LAW,
by:
prevention device as
Specified under § 5-202.14.
6
5-203.15
Backflow Prevention Device, Carbonator.*
7
(A)
8
202.13, a double check valve with an intermediate vent preceded by
9
a screen of not less than 100 mesh to 25.4 mm (100 mesh to 1
If not provided with an air gap as specified under § 5-
10
inch) shall be installed upstream from a carbonating device and
11
downstream from any copper in the water supply line.
12
(B)
13
need not be of the vented type if an air gap or vented backflow
14
prevention device has been otherwise provided as specified under
15
(A) of this section.
A single or double check valve attached to the carbonator
16
Location and
5-204.11
17
Placement
A
18
Handwashing Sinks.*
HANDWASHING SINK
(A)
19
shall be located:
To allow convenient use by
FOOD
dispensing, and
EMPLOYEES
WAREWASHING
in
FOOD
preparation,
areas; and
20
(B)
In, or immediately adjacent to, toilet rooms.
21
5-204.12
22
A backflow prevention device shall be located so that it may be
23
serviced and maintained.
Backflow Prevention Device, Location.
213
07.10.13
1
5-204.13
2
A water filter, screen, and other water conditioning device
3
installed on water lines shall be located to facilitate disassembly
4
for periodic servicing and cleaning.
5
Operation and
5-205.11
6
Maintenance
(A)
(B)
9
10
Using a Handwashing Sink.
HANDWASHING SINK
shall be maintained so that it is
accessible at all times for
7
8
A
Conditioning Device, Location.
A
HANDWASHING SINK
EMPLOYEE
use.
shall not be used for purposes other
than handwashing.
(C)
11
An automatic handwashing facility shall be used in accordance
with manufacturer’s instructions.
12
5-205.12
13
(A)
A
Prohibiting a Cross Connection.*
PERSON
shall not create a cross connection by
14
connecting a pipe or conduit between the DRINKING WATER
15
system and a non
16
system of unknown quality.
17
(B)
DRINKING WATER
The piping of a nonDRINKING
system or a water
WATER
system shall be
18
durably identified so that it is readily distinguishable from
19
piping that carries
20
21
5-205.13
DRINKING WATER.
N
Scheduling Inspection and Service for a Water
System Device.
214
1
07.10.13
A device such as a water treatment device or backflow preventer
2
shall be scheduled for inspection and service, in accordance with
3
manufacturer's instructions and as necessary to prevent device
4
failure based on local water conditions, and records demonstrating
5
inspection and service shall be maintained by the PERSON IN CHARGE.
6
5-205.14
7
(A)
Water Reservoir of Fogging Devices, Cleaning.*
A reservoir that is used to supply water to a device such
8
as a produce fogger shall be:
9
(1)
10
Maintained
in
accordance
with
manufacturer's
specifications; and
11
(2)
Cleaned in accordance with manufacturer's specifications
12
or according to the procedures specified under ¶(B)
13
of this section, whichever is more stringent.
14
(B)
Cleaning procedures shall include at least the following steps
15
and shall be conducted at least once a week:
16
(1)
17
18
aerosol contact parts;
(2)
19
20
21
Draining and complete disassembly of the water and
Brush-cleaning the reservoir, aerosol tubing, and
discharge nozzles with a suitable detergent solution;
(3)
Flushing the complete system with water to remove the
detergent solution and particulate accumulation; and
215
1
(4)
07.10.13
Rinsing by immersing, spraying, or swabbing the
2
reservoir, aerosol tubing, and discharge nozzles with
3
at least 50 MG/L hypochlorite solution.
4
5-205.15
System Maintained in Good Repair.*
5
A
6
(A)
Repaired according to
7
(B)
Maintained in good repair.S
PLUMBING SYSTEM
shall be:
LAW;
and
8
9
5-3
MOBILE WATER TANK AND MOBILE FOOD ESTABLISHMENT WATER
10
TANK
11
Subparts
12
5-301
Materials
13
5-302
Design and Construction
14
5-303
Numbers and Capacities
15
5-304
Operation and Maintenance
5-301.11
Approved.
16
17
Materials
18
Materials that are used in the construction of a mobile water tank,
19
mobile FOOD ESTABLISHMENT water tank, and appurtenances shall be:
20
(A)
Safe;
21
(B)
Durable, CORROSION-RESISTANT, and nonabsorbent; and
22
(C)
Finished to have a
23
Design and 5-302.11
SMOOTH, EASILY CLEANABLE
Enclosed System, Sloped to Drain.
216
surface.
07.10.13
1
Construction
A mobile water tank shall be:
2
(A)
Enclosed from the filling inlet to the discharge outlet; and
3
(B)
Sloped to an outlet that allows complete drainage of the
4
5
tank.
5-302.12
6
Inspection and Cleaning Port, Protected and
Secured.
7
If a water tank is designed with an access port for inspection and
8
cleaning, the opening shall be in the top of the tank and:
9
(A)
Flanged upward at least 13 mm (one-half inch); and
10
(B)
Equipped with a port cover assembly that is:
11
(1)
12
Provided
with a gasket and
a device for securing
the cover in place, and
13
(2)
14
5-302.13
15
A fitting with “V” type threads on a water tank inlet or outlet shall
16
be allowed only when a hose is permanently attached.
17
5-302.14
18
If provided, a water tank vent shall terminate in a downward
19
direction and shall be covered with:
20
(A)
21
Flanged to overlap the opening and sloped to drain.
“V” Type Threads, Use Limitation.
Tank Vent, Protected.
16 mesh to 25.4 mm (16 mesh to 1 inch) screen or
equivalent when the vent is in a protected area; or
217
1
(B)
2
07.10.13
A protective filter when the vent is in an area that is not
protected from windblown dirt and debris.
3
5-302.15
Inlet and Outlet, Sloped to Drain.
4
(A)
A water tank and its inlet and outlet shall be sloped to drain.
5
(B)
A water tank inlet shall be positioned so that it is protected
6
from contaminants such as waste discharge, road dust, oil,
7
or grease.
8
5-302.16
Hose, Construction and Identification.
9
A hose used for conveying
DRINKING WATER
from a water tank shall
10
be:
11
(A)
Safe;
12
(B)
Durable,
13
(C)
Resistant to pitting, chipping, crazing, scratching, scoring,
14
CORROSION-RESISTANT,
and nonabsorbent;
distortion, and decomposition;
15
(D)
Finished with a
16
(E)
Clearly
17
and
SMOOTH
durably
interior surface; and
identified
as
to
its
use
if
not
permanently attached.
18
Numbers and
5-303.11
Filter, Compressed Air.
19
Capacities
A filter that does not pass oil or oil vapors shall be installed in the
20
air supply line between the compressor and
21
when compressed air
22
system.
23
5-303.12
DRINKING WATER
system
is used to pressurize the water
Protective Cover or Device.
218
tank
1
07.10.13
A cap and keeper chain, closed cabinet, closed storage tube, or
2
other
3
water inlet, outlet, and hose.
4
5-303.13
5
A mobile
6
(A)
19.1 mm (three-fourths inch) in inner diameter or less; and
7
(B)
Provided with a hose connection of a size or type that will
8
9
10
APPROVED
protective cover or device shall be provided for a
Mobile Food Establishment Tank Inlet.
FOOD ESTABLISHMENT'S
water tank inlet shall be:
prevent its use for any other service.
Operation and
5-304.11
System Flushing and Sanitization.*
Maintenance
A water tank, pump, and hoses shall be flushed and
SANITIZED
11
before being placed in service after construction, repair modification,
12
and periods of nonuse.
13
5-304.12
14
A
15
and other contamination of the water supply are prevented.
16
5-304.13
17
If not in use, a water tank and hose inlet and outlet fitting shall
18
be protected using a cover or device as specified under § 5-303.12.
19
5-304.14
20
(A)
Using a Pump and Hoses, Backflow Prevention.
PERSON shall operate a water tank, pump, and hoses so that backflow
Protecting Inlet, Outlet, and Hose Fitting.
Tank, Pump, and Hoses, Dedication.
Except as specified in ¶(B) of this section, a water tank,
21
pump, and hoses used for conveying
22
used for no other purpose.
23
(B)
Water tanks, pumps, and hoses
219
DRINKING WATER
shall be
APPROVED for liquid FOODS may
1
be used for conveying
2
and
SANITIZED
DRINKING WATER
07.10.13
if they are cleaned
before they are used to convey water.
3
4
5-4
5
SEWAGE, OTHER LIQUID WASTE, AND RAINWATER
Subparts
6
5-401
Mobile Holding Tank
7
5-402
Retention, Drainage, and Delivery
8
5-403
Disposal Facility
Capacity and Drainage.
9
10
Mobile Holding
5-401.11
11
Tank
A
12
SEWAGE
(A)
13
holding tank in a mobile
FOOD ESTABLISHMENT
shall be:
Sized 15 percent larger in capacity than the water supply
tank; and
14
(B)
15
Sloped to a drain that is 25 mm (1 inch) in inner diameter or
greater, equipped with a shut-off valve.
16
Retention,
5-402.10
Establishment Drainage System.
17
Drainage, and
FOOD
18
Delivery
that convey
19
design,
under ¶ 5-202.11(A).
20
construction, and
21
installation
ESTABLISHMENT
22
5-402.11
23
(A)
SEWAGE
drainage
systems, including grease traps,
shall be designed and installed as specified
Backflow Prevention.*
Except as specified in ¶¶ (B), (C), and (D) of this section, a
220
1
07.10.13
direct connection shall not exist between the SEWAGE system and a
2
drain originating from EQUIPMENT in which FOOD, portable EQUIPMENT,
3
or UTENSILS are placed.
4
(B)
Paragraph (A) of this section does not apply to floor drains
5
that originate in refrigerated spaces that are constructed as
6
an integral part of the building.
(C)
7
If allowed by
LAW,
a
WAREWASHING
machine may have a
8
direct connection between its waste outlet and a floor drain
9
when the machine is located within 1.5 m (5 feet) of a
10
trapped floor drain and the machine outlet is connected to the
11
inlet side of a properly vented floor drain trap.
(D)
12
13
If allowed by
LAW,
a
WAREWASHING
or culinary sink may have
a direct connection.
14
location and
5-402.12
15
placement
If used, a grease trap shall be located to be easily accessible for
16
Grease Trap.
cleaning.
17
operation and
5-402.13
Conveying Sewage.*
18
maintenance
SEWAGE shall be conveyed to the point of
19
APPROVED
20
SEWAGE
sanitary
SEWAGE
disposal through an
system or other system, including use of
transport vehicles, waste retention tanks, pumps, pipes,
21
hoses, and connections that are constructed, maintained, and
22
operated according to
23
5-402.14
LAW.
Removing Mobile Food Establishment Wastes.
221
1
07.10.13
SEWAGE and other liquid wastes shall be removed from a mobile
2
FOOD ESTABLISHMENT
3
SEWAGE transport
at an
SERVICING AREA
or by a
vehicle in such a way that a public health
HAZARD
APPROVED
waste
4
or nuisance is not created.
5
5-402.15
6
A tank for liquid waste retention shall be thoroughly flushed and
7
drained in a sanitary manner during the servicing operation.
8
Disposal Facility
5-403.11
Flushing a Waste Retention Tank.
Approved Sewage Disposal System.*
9
design and
SEWAGE shall be disposed through an
10
construction
(A)
A public
(B)
An individual
11
12
SEWAGE
APPROVED
facility that is:
treatment plant; or
SEWAGE
disposal system that is sized, constructed,
maintained, and operated according to LAW.
13
5-403.12
Other Liquid Wastes and Rainwater.
14
Condensate drainage and other nonSEWAGE liquids and rainwater
15
shall be drained from point of discharge to disposal according to
16
LAW.
17
18
19
5-5
REFUSE, RECYCLABLES, AND RETURNABLES
Subparts
20
5-501
Facilities on the Premises
21
5-502
Removal
22
5-503
Facilities for Disposal and Recycling
5-501.10
Indoor Storage Area.
23
Facilities on the
222
07.10.13
a storage area for
1
Premises
If located within the
2
materials, design,
REFUSE,
3
construction, and
specified under §§ 6-101.11, 6-201.11–6-201.18, 6-202.15, and
4
installation
6-202.16
FOOD ESTABLISHMENT,
recyclables, and returnables shall meet the requirements
5
5-501.11
Outdoor Storage Surface.
6
An outdoor storage surface for
7
shall be constructed of nonabsorbent material such as concrete or
8
asphalt and shall be
9
5-501.12
REFUSE,
SMOOTH,
recyclables, and returnables
durable, and sloped to drain.
Outdoor Enclosure.
10
If used, an outdoor enclosure for REFUSE, recyclables, and returnables
11
shall be constructed of durable and cleanable materials.
12
5-501.13
13
(A)
Receptacles.
Except as specified in ¶ (B) of this section, receptacles and
14
waste handling units for
15
and for use with materials containing
16
durable, cleanable, insect-and rodent-resistant, leakproof, and
17
non absorbent.
18
(B)
REFUSE,
recyclables, and returnables
FOOD
residue shall be
Plastic bags and wet strength paper bags may be used to
19
line receptacles for storage inside the
20
or within closed outside receptacles.
21
5-501.14
22
Except for a receptacle for
23
REFUSE
FOOD ESTABLISHMENT,
Receptacles in Vending Machines.
BEVERAGE
bottle crown closures, a
receptacle shall not be located within a
223
VENDING MACHINE.
07.10.13
1
5-501.15
2
(A)
Outside Receptacles.
Receptacles and waste handling units for
REFUSE, recyclables,
3
and returnables used with materials containing FOOD residue
4
and used outside the
5
and constructed to have tight-fitting lids, doors, or covers.
6
(B)
FOOD ESTABLISHMENT
shall be designed
Receptacles and waste handling units for REFUSE and recyclables
7
such as an on-site compactor shall be installed so that
8
accumulation of debris and insect and rodent attraction and
9
harborage are minimized and effective cleaning is facilitated
10
around and, if the unit is not installed flush with the base
11
pad, under the unit.
12
numbers and
13
capacities
14
5-501.16
Storage Areas, Rooms, and Receptacles Capacity,
and Availability.
(A)
An inside storage room and area and outside storage area
15
and enclosure, and receptacles shall be of sufficient capacity
16
to hold
17
(B)
REFUSE,
recyclables, and returnables that accumulate.
A receptacle shall be provided in each area of the
18
ESTABLISHMENT
19
commonly discarded, or where recyclables or returnables
20
are placed.
21
(C)
or
PREMISES
where
FOOD
REFUSE
is generated or
If disposable towels are used at handwashing lavatories,
22
a waste receptacle shall be located at each lavatory or
23
group of adjacent lavatories.
224
07.10.13
1
5-501.17
Toilet Room Receptacle, Covered.
2
A toilet room used by females shall be provided with a covered
3
receptacle for sanitary napkins.
4
5-501.18
5
(A)
Cleaning Implements and Supplies.
Except
as
specified
in ¶ (B)
of
this
section,
suitable
6
cleaning implements and supplies such as high pressure pumps,
7
hot water, steam, and detergent shall be provided
8
necessary for effective cleaning of receptacles and waste
9
handling units for
10
(B)
If
REFUSE,
as
recyclables, and returnables.
APPROVED, off-PREMISES-based cleaning services
may be used
11
if on-PREMISES cleaning implements and supplies are not
12
provided.
13
location and
14
placement
15
5-501.19
Storage Areas, Redeeming Machines, Receptacles
and Waste Handling Units, Location.
(A)
An area designated for
REFUSE,
recyclables, returnables, and,
16
except as specified in ¶(B) of this section, a redeeming machine
17
for recyclables or returnables shall be located so that it is
18
separate from
19
SERVICE
20
or nuisance is not created.
21
22
23
(B)
and
FOOD, EQUIPMENT, UTENSILS, LINENS,
SINGLE-USE ARTICLES
and
SINGLE-
and a public health
HAZARD
A redeeming machine may be located in the
storage area or
CONSUMER
area of a
FOOD, EQUIPMENT, UTENSILS, LINENS,
225
PACKAGED FOOD
FOOD ESTABLISHMENT
and
SINGLE-SERVICE
if
and
07.10.13
are not subject to contamination from the
1
SINGLE-USE ARTICLES
2
machines and a public health
3
created.
4
(C)
The
location of receptacles
5
REFUSE,
6
public health
7
cleaning of adjacent space.
HAZARD
and
or nuisance is not
waste handling units for
recyclables, and returnables shall not
HAZARD
or nuisance or
create a
interfere with the
8
operation and
5-501.110
Storing Refuse, Recyclables, and Returnables.
9
maintenance
REFUSE, recyclables, and returnables shall be stored in receptacles
10
or waste handling units so that they are inaccessible to insects
11
and rodents.
12
5-501.111
13
Storage areas, enclosures, and receptacles for
14
and returnables shall be maintained in good repair.
15
5-501.112
16
(A)
Areas, Enclosures, and Receptacles, Good Repair.
REFUSE,
recyclables,
Outside Storage Prohibitions.
Except
as
specified
in &(B)
of
this
section,
REFUSE
17
receptacles not meeting the requirements specified under
18
¶5-501.13(A) such as receptacles that are not rodent-resistant,
19
unprotected plastic bags and paper bags, or baled units that
20
contain materials with FOOD residue may not be stored outside.
21
(B)
Cardboard or other packaging material that does not contain
22
FOOD
residues
and
23
delivery to a recycling or disposal site may be stored outside
226
that
is
awaiting regularly scheduled
1
07.10.13
without being in a covered receptacle if it is stored so that
2
it does not create a rodent harborage problem.
3
5-501.113
Covering Receptacles.
4
Receptacles and waste handling units for
5
returnables shall be kept covered:
6
(A)
Inside the
FOOD ESTABLISHMENT
7
(1)
Contain
8
(2)
After they are filled; and
9
(B)
10
FOOD
REFUSE,
recyclables, and
if the receptacles and units:
residue and are not in continuous use;
With tight-fitting lids or doors if kept outside the
FOOD
ESTABLISHMENT.
11
5-501.114
Using Drain Plugs.
12
Drains in receptacles and waste handling units for REFUSE, recyclables,
13
and returnables shall have drain plugs in place.
14
5-501.115
15
A storage area and enclosure for REFUSE, recyclables, or returnables
16
shall be maintained free of unnecessary items, as specified under
17
6-501.114, and clean.
18
5-501.116
19
(A)
Maintaining Refuse Areas and Enclosures.
Cleaning Receptacles.
Receptacles and waste handling units for
REFUSE, recyclables,
20
and returnables shall be thoroughly cleaned in a way that
21
does not contaminate
22
SINGLE-SERVICE
23
be disposed of as specified under § 5-402.13.
FOOD, EQUIPMENT, UTENSILS, LINENS,
or
and SINGLE-USE ARTICLES, and waste water shall
227
(B)
1
Soiled receptacles and waste handling units for
07.10.13
REFUSE,
2
recyclables, and returnables shall be cleaned at a frequency
3
necessary to prevent them from developing a buildup of soil
4
or becoming attractants for insects and rodents.
5
Removal
5-502.11
Frequency.
6
REFUSE, recyclables, and returnables shall be removed from the
7
PREMISES
8
objectionable odors and other conditions that attract or harbor
9
insects and rodents.
at a frequency that will minimize the development of
10
5-502.12
11
REFUSE, recyclables, and returnables shall be removed from the
12
PREMISES
13
(A)
14
Receptacles or Vehicles.
by way of:
Portable receptacles that are constructed and maintained
according to
15
(B)
16
LAW;
or
A transport vehicle that is constructed, maintained, and
operated according to
LAW.
17
Facilities for
5-503.11
18
Disposal and
Solid waste not disposed of through the
19
Recycling
through grinders and pulpers shall be recycled or disposed of in an
20
Community or Individual Facility.
SEWAGE
system such as
public or private community recycling or
REFUSE
facility;
21
or solid waste shall be disposed of in an individual
REFUSE
facility
22
such as a landfill
23
maintained, and operated according to
APPROVED
or incinerator which is sized, constructed,
228
LAW.
07.10.13
1
Chapter
2
4
3
Parts
4
4-1
MATERIALS FOR CONSTRUCTION AND REPAIR
5
4-2
DESIGN AND CONSTRUCTION
6
4-3
NUMBERS AND CAPACITIES
7
4-4
LOCATION AND INSTALLATION
8
4-5
MAINTENANCE AND OPERATION
9
4-6
CLEANING OF EQUIPMENT AND UTENSILS
10
4-7
SANITIZATION OF EQUIPMENT AND UTENSILS
11
4-8
LAUNDERING
12
4-9
PROTECTION OF CLEAN ITEMS
4-1
MATERIALS FOR CONSTRUCTION AND REPAIR
Equipment, Utensils, and Linens
13
14
15
Subparts
16
4-101
Multiuse
17
4-102
Single-Service and Single-Use
4-101.11
Characteristics.*
18
19
Multiuse
20
Materials that are used in the construction of
21
FOOD-CONTACT
22
migration of deleterious substances or impart colors, odors, or
SURFACES
146
of
EQUIPMENT
shall
UTENSILS
not
and
allow the
07.10.13
and under normal use conditions shall be:
1
tastes to
2
(A)
Safe;
3
(B)
Durable,
4
(C)
Sufficient in weight and thickness to withstand repeated
5
FOOD
CORROSION-RESISTANT,
WAREWASHING;
and nonabsorbent;N
N
N
6
(D)
Finished to have a
7
(E)
Resistant to pitting, chipping, crazing, scratching, scoring,
10
and
distortion, and decomposition.N
8
9
SMOOTH, EASILY CLEANABLE surface;
4-101.12
(A)
Cast Iron, Use Limitation.
Except
as specified in ¶¶ (B) and (C) of this section,
11
cast iron shall not
12
CONTACT SURFACES
of
be used
for
UTENSILS
or
FOOD-
EQUIPMENT.
13
B)
Cast iron may be used as a surface for cooking.
14
(C)
Cast iron may be used in
UTENSILS
for serving
15
UTENSILS
16
process from cooking through service.
17
4-101.13
18
(A)
FOOD
if the
are used only as part of an uninterrupted
Lead, Use Limitation.
Ceramic, china, and crystal UTENSILS, and decorative UTENSILS
19
such as hand painted ceramic or china that are used in
20
contact with
21
lead not
22
categories:
23
24
UTENSIL
Category
FOOD
shall be lead-free or contain levels of
exceeding the limits of the following
Ceramic
Article Description
147
UTENSIL
Maximum Lead
MG/L
07.10.13
1
2
3
4
5
6
7
8
9
10
11
Beverage Mugs,
Cups, Pitchers
Coffee Mugs
Large Hollowware
(excluding pitchers)
Small Hollowware
(excluding cups & mugs)
Flat TABLEWARE
0.5
Bowls > 1.1 Liter
(1.16 Quart)
1
Bowls < 1.1 Liter
(1.16 Quart)
2.0
Plates, Saucers
3.0
12
13
(B)
14
15
Pewter alloys containing lead in excess of 0.05% shall
not be used as a
(C)
16
FOOD-CONTACT SURFACE.
Solder and flux containing lead in excess of 0.2% shall not
be used as a
17
4-101.14
18
(A)
FOOD-CONTACT SURFACE.
Copper, Use Limitation.*
Except as specified in ¶ (B) of this section, copper and
19
copper
20
contact with a
21
vinegar,
22
installed between a backflow prevention device and a
23
carbonator.
24
(B)
alloys such as brass shall
fruit
not be used in
FOOD
that has a pH below 6 such as
JUICE,
or wine or for a fitting or tubing
Copper and copper alloys may be used in contact with
25
beer brewing ingredients that have a pH below 6 in the
26
prefermentation and fermentation steps of a beer brewing
27
operation such as a brewpub or microbrewery.
148
07.10.13
1
4-101.15
Galvanized Metal, Use Limitation.*
2
Galvanized metal shall not be used for
3
CONTACT SURFACES
4
acidic
5
4-101.16
6
Sponges shall not be used in contact with cleaned and
7
SANITIZED
8
4-101.17
9
(A)
of
EQUIPMENT
UTENSILS
or
that are used in contact with
FOOD.
Sponges, Use Limitation.
or in-use
FOOD-CONTACT SURFACES.
Wood, Use Limitation.
Except as specified in ¶¶ (B), (C), and (D) of this section,
10
wood and wood wicker shall not be used as a
11
CONTACT SURFACE.
12
(B)
FOOD-
Hard maple or an equivalently hard, close-grained wood
13
may be used for:
14
(1)
Cutting boards; cutting blocks; bakers' tables; and
15
UTENSILS
16
salad bowls, and chopsticks; and
17
FOOD-
(2)
such as rolling pins, doughnut dowels,
Wooden paddles used in confectionery operations
18
for
19
preparing confections at a temperature of 110oC (230oF)
20
or above.
21
(C)
pressure
scraping
kettles
when manually
Whole, uncut, raw fruits and vegetables, and nuts in the
22
shell may be kept in the wood shipping containers in
23
which they were received, until the fruits, vegetables, or
149
07.10.13
1
nuts are used.
(D)
2
If the nature of
the
FOOD
requires removal of rinds,
3
peels, husks, or shells before consumption, the whole,
4
uncut, raw
5
(1)
Untreated wood containers; or
6
(2)
Treated wood containers if the containers are treated
FOOD
may be kept in:
7
with a
preservative that meets the requirements
8
specified in 21 CFR 178.3800 Preservatives for wood.
9
4-101.18
Nonstick Coatings, Use Limitation.
10
Multiuse
11
pans, cookie sheets, and waffle bakers that have a perfluorocarbon
12
resin coating shall
KITCHENWARE
such as frying pans, griddles, sauce
be used with nonscoring or nonscratching
13
UTENSILS
and cleaning aids.
14
4-101.19
15
NonFOOD-CONTACT SURFACES of EQUIPMENT that are exposed to splash,
16
spillage, or other FOOD soiling or that require frequent cleaning shall
17
be constructed of a
18
SMOOTH
Nonfood-Contact Surfaces.
CORROSION-RESISTANT,
and
material.
19
Single-Service
4-102.11
20
and Single-Use
Materials that are used to make
21
ARTICLES:
22
(A)
23
nonabsorbent,
Characteristics.*
SINGLE-SERVICE
and
SINGLE-USE
May not:
(1)
Allow the migration of deleterious substances, or
150
(2)
1
2
(B)
Impart colors, odors, or tastes to
FOOD;
N
07.10.13
and
Shall be:
3
(1)
Safe, and
4
(2)
Clean.N
5
6
4-2
7
DESIGN AND CONSTRUCTION
Subparts
8
4-201
Durability and Strength
9
4-202
Cleanability
10
4-203
Accuracy
11
4-204
Functionality
12
4-205
Acceptability
Equipment and Utensils.
13
14
Durability and
4-201.11
15
Strength
EQUIPMENT and
UTENSILS
shall be designed and constructed to
16
be durable and to retain their characteristic qualities under
17
normal use conditions.
18
4-201.12
19
FOOD
20
or stems constructed of glass, except that thermometers with
21
glass sensors or stems that are encased in a shatterproof
22
coating such as candy thermometers may be used.
23
Cleanability
Food Temperature Measuring Devices.*
TEMPERATURE MEASURING DEVICES
4-202.11
Food-Contact Surfaces.*
151
shall not have sensors
07.10.13
1
(A)
Multiuse
FOOD-CONTACT SURFACES
shall be:
2
(1)
SMOOTH;
3
(2)
Free of breaks, open seams, cracks, chips, inclusions,
4
pits, and similar imperfections;
5
(3)
6
Free
of
sharp
internal
SMOOTH
angles,
corners,
and
crevices;
7
(4)
Finished to have
8
(5)
Except
9
as
specified
welds and joints; and
in ¶ (B)
of
this section,
accessible for cleaning and inspection by one of the
10
following methods:
11
(a)
Without being disassembled,
12
(b)
By disassembling without the use of tools,
13
or
14
(c)
By easy disassembling
15
handheld
16
maintenance and cleaning personnel such as
17
screwdrivers, pliers, open-end wrenches, and
18
Allen wrenches.
19
(B)
20
tools
with the use of
commonly
available
to
Subparagraph (A)(5) of this section does not apply to cooking
oil storage tanks, distribution lines for cooking oils, or
21
BEVERAGE
syrup lines or tubes.
22
4-202.12
CIP Equipment.
23
(A)
EQUIPMENT
CIP
152
shall meet the characteristics specified
1
07.10.13
under § 4-202.11 and shall be designed and constructed so
2
that:
3
(1)
Cleaning
and
solutions
SANITIZING
circulate
4
throughout a fixed system and contact all interior
5
FOOD-CONTACT SURFACES,
6
(2)
and
The system is self-draining or capable of being
7
completely drained of cleaning and SANITIZING solutions;
8
and
9
(B)
CIP
EQUIPMENT
that is not designed to be disassembled
10
for cleaning shall be designed with inspection access
11
points to ensure that all
12
throughout the fixed system are being effectively cleaned.
interior
FOOD-CONTACT SURFACES
13
4-202.13
“V” Threads, Use Limitation.
14
Except
15
threads shall not be used on
16
4-202.14
17
Hot oil filtering
18
specified under
19
accessible for filter replacement and cleaning of the filter.
20
4-202.15
21
Cutting or piercing parts of can openers shall be readily
22
removable for cleaning and for replacement.
23
4-202.16
for hot oil cooking or filtering
EQUIPMENT,
“V” type
FOOD-CONTACT SURFACES.
Hot Oil Filtering Equipment.
EQUIPMENT
shall
meet the characteristics
§ 4-202.11 or § 4-202.12 and shall be readily
Can Openers.
Nonfood-Contact Surfaces.
153
07.10.13
shall be free of unnecessary
1
NonFOOD-CONTACT
2
ledges,
3
constructed
4
maintenance.
5
4-202.17
6
Kick plates shall be designed so that the areas behind them
7
are accessible for inspection and cleaning by being:
8
(A)
9
SURFACES
projections,
to
and
allow
crevices,
easy
cleaning
and
designed
and
to
and
facilitate
Kick Plates, Removable.
Removable by one of the methods specified under
Subparagraph 4-202.11(A)(5) or capable of being rotated
10
open; and
11
(B)
12
Removable or capable of being rotated open without unlocking
EQUIPMENT
doors.
13
4-202.18
14
Filters or other grease extracting
15
to be readily removable for cleaning and replacement if not
16
designed to be cleaned in place.
17
18
Accuracy
Ventilation Hood Systems, Filters.
EQUIPMENT
shall be designed
4-203.11
Temperature Measuring Devices, Food.
(A)
TEMPERATURE MEASURING DEVICES
FOOD
that are scaled
19
only in Celsius or dually scaled in Celsius and Fahrenheit
20
shall be accurate to ±1oC in the intended range of use.
21
(B)
FOOD
TEMPERATURE MEASURING DEVICES
that are scaled
22
only in Fahrenheit shall be accurate to ±2oF in the intended
23
range of use.
154
1
4-203.12
2
07.10.13
Temperature Measuring Devices, Ambient Air
and Water.
(A)
3
Ambient air and water
TEMPERATURE MEASURING DEVICES
4
that are scaled in Celsius or dually scaled in Celsius and
5
Fahrenheit shall be designed to be easily readable and
6
accurate to ±1.5oC in the intended range of use.
7
(B)
Ambient air and water
TEMPERATURE MEASURING DEVICES that
8
are scaled only in Fahrenheit shall be accurate to ±3oF in
9
the intended range of use.
10
4-203.13
11
Pressure
Measuring
Devices,
Mechanical
Warewashing Equipment.
12
Pressure measuring devices that display the pressures in the
13
water supply line for the fresh hot water sanitizing rinse shall
14
have increments of 7 kilopascals (1 pound per square inch) or
15
smaller and shall be accurate to ±14 kilopascals (±2 pounds
16
per square inch) in the range indicated on the manufacturer's
17
data plate.
18
Functionality
4-204.11
Ventilation Hood Systems, Drip Prevention.
19
Exhaust ventilation hood systems in
20
WAREWASHING
FOOD
preparation and
areas including components such as hoods, fans,
21
guards, and ducting shall be designed to prevent grease or
22
condensation from draining or dripping onto
23
UTENSILS, LINENS,
and
SINGLE-SERVICE
155
and
FOOD, EQUIPMENT,
SINGLE-USE ARTICLES.
1
4-204.12
2
(A)
3
4
07.10.13
Equipment Openings, Closures and Deflectors.
A cover or lid for
shall overlap the opening
and be sloped to drain.
(B)
An opening located within the top of a unit of
5
that is designed
6
flanged upward at
7
inch).
8
EQUIPMENT
(C)
9
EQUIPMENT
for use with a cover or lid shall be
least 5 millimeters (two-tenths of an
Except as specified under ¶ (D) of this section, fixed
TEMPERATURE MEASURING DEVICES,
piping,
rotary shafts, and
10
other parts extending into
11
with a watertight joint at the point where the item enters
12
the
13
(D)
shall be provided
EQUIPMENT.
If a watertight joint is not provided:
(1)
14
EQUIPMENT
The piping, TEMPERATURE
rotary
15
shafts,
16
openings
17
designed to deflect condensation, drips, and dust
18
from openings into the
19
(2)
20
21
other parts extending through the
shall
be
equipped
FOOD;
with
an
apron
and
The opening shall be flanged as specified under ¶
(B) of this section.
4-204.13
22
23
and
MEASURING DEVICES,
Dispensing Equipment, Protection of Equipment
and Food.
In
EQUIPMENT
that dispenses or vends liquid
156
FOOD
or ice in
07.10.13
1
unPACKAGED form:
2
(A)
The delivery tube, chute, orifice, and splash surfaces
3
directly above the container receiving the
4
designed in a manner, such as with barriers, baffles, or
5
drip aprons, so that drips from condensation and splash
6
are diverted from the opening of the container receiving
7
the
8
(B)
9
10
FOOD
shall be
FOOD;
The delivery tube, chute, and orifice shall be protected
from manual contact such as by being recessed;
(C)
The
delivery tube or chute and orifice of
EQUIPMENT
11
used to vend liquid
12
self-service
13
delivery tube or chute and
orifice are protected from
14
dust, insects, rodents, and
other
15
self-closing door if the
16
(1)
FOOD
CONSUMERS
or ice in unPACKAGED form to
shall be designed
EQUIPMENT
so that the
contamination by a
is:
Located in an outside area that does not otherwise
17
afford the protection of an enclosure against the
18
rain, windblown debris, insects, rodents, and other
19
contaminants that are present in the environment,
20
or
21
(2)
Available for self-service during hours when it is
22
not under the full-time supervision of a
23
and
157
FOOD EMPLOYEE;
1
(D)
The
dispensing
EQUIPMENT
07.10.13
actuating lever or mechanism
2
and filling device of
3
dispensing
4
with the lip-contact surface of glasses or cups that are
5
refilled.
6
(E)
EQUIPMENT
CONSUMER
self-service
BEVERAGE
shall be designed to prevent contact
Dispensing equipment
in which
food (time/temperature control
8
homogenous liquid form is maintained outside of
9
temperature control requirements as specified under §3501.16(A) shall:
11
(1)
safety
hazardous
7
10
for
potentially
food )
in
a
the
be specifically designed and equipped to maintain
12
the commercial
13
food in a homogenous liquid form for a specified
14
duration from the time of opening the packaging
15
within the equipment; and
16
(2)
sterility of aseptically packaged
conform to the requirements for this equipment as
17
specified in NSF/ANSI 18-2006- Manual Food and
18
Beverage Dispensing Equipment.
19
4-204.14
Vending Machine, Vending Stage Closure.
20
The dispensing compartment of a
21
machine
22
that is not
23
FOR SAFETY FOOD)
that
VENDING MACHINE
including a
is designed to vend prePACKAGED snack
POTENTIALLY HAZARDOUS
such
158
FOOD
(TIME/TEMPERATURE CONTROL
as chips, party mixes,
and pretzels
1
07.10.13
shall be equipped with a self-closing door or cover if the
2
machine is:
3
(A)
Located in an outside area that does not otherwise afford
4
the protection of an enclosure against the rain, windblown
5
debris, insects, rodents, and other contaminants that are
6
present in the environment; or
7
(B)
under the full-time supervision of a
8
9
Available for self-service during hours when it is not
FOOD EMPLOYEE.
4-204.15
Bearings and Gear Boxes, Leak proof.
10
EQUIPMENT
containing
11
lubricants shall be designed
12
lubricant
13
FOOD-CONTACT SURFACES.
14
4-204.16
15
Except for cold plates that are constructed integrally with an
16
ice storage bin,
17
cooling devices shall not be installed in contact with stored
18
ice.
19
4-204.17
20
Liquid waste drain lines shall not pass through an ice machine or
21
ice storage bin.
22
4-204.18
23
If a condenser unit is an integral component of
cannot
bearings
and
and
gears
that
require
constructed so that
leak, drip, or be forced into
FOOD
the
or onto
Beverage Tubing, Separation.
BEVERAGE
tubing and cold-plate
BEVERAGE
Ice Units, Separation of Drains.
Condenser Unit, Separation.
159
EQUIPMENT,
the
07.10.13
and FOOD
1
condenser unit shall be separated from the
2
storage space by a dustproof barrier.
3
4-204.19
4
Cutting or piercing parts of can openers on
5
shall be protected from manual contact, dust, insects, rodents,
6
and other contamination.
7
4-204.110
8
(A)
9
FOOD
Can Openers on Vending Machines.
VENDING MACHINES
Molluscan Shellfish Tanks.
Except as specified under ¶ (B) of this section,
SHELLFISH
MOLLUSCAN
life support system display tanks shall not be
10
used to display shellfish that are offered for human
11
consumption and shall be conspicuously marked so that
12
it is obvious to the
13
display only.
14
(B)
MOLLUSCAN
SHELLFISH
CONSUMER
that the shellfish are for
life-support system display tanks that
15
are used to store and display shellfish that are offered for
16
human consumption shall be operated and maintained in
17
accordance with a
18
AUTHORITY
19
that:
20
(1)
21
22
23
VARIANCE
granted by the
REGULATORY
as specified in § 8-103.10 and a HACCP
Is submitted by the
PERMIT HOLDER
and
PLAN
APPROVED
as specified under § 8-103.11; and
(2)
Ensures that:
(a)
Water used with
160
FISH
other than
MOLLUSCAN
1
SHELLFISH
2
tank,
3
(b)
07.10.13
does not flow into the molluscan
The safety and quality of the shellfish as
4
they
5
by the use of the tank, and
6
(c)
were
received
are not compromised
The identity of the source of the
7
SHELLSTOCK
is retained as specified under § 3-203.12.
8
4-204.111
9
(A)
A
Vending Machines, Automatic Shutoff.*
machine
vending
POTENTIALLY
HAZARDOUS
CONTROL FOR SAFETY FOOD)
FOOD
10
(TIME/TEMPERATURE
shall have
11
an automatic control that prevents the machine from
12
vending
13
(1)
FOOD:
If there is a power failure, mechanical failure, or
14
other condition that results in an internal machine
15
temperature
16
temperatures as specified under Chapter 3; and
17
(2)
that
cannot
of
19
serviced and restocked with
20
maintained
21
Chapter 3.
23
(B)
FOOD
If a condition specified under Subparagraph (A)(1)
18
22
maintain
this
section
at
occurs, until
the
FOOD
temperatures
machine
is
that has been
specified
under
When the automatic shutoff within a machine vending
potentially
hazardous food (time/temperature control for
161
07.10.13
1
safety food) is activated:
2
(1)
In a refrigerated vending machine, the ambient air
3
temperature shall not exceed 5°C (41°F) for more
4
than 30 minutes immediately after the machine is
5
filled, serviced, or restocked; or
6
(2)
In a hot holding vending machine, the ambient air
7
temperature shall not be less than 57°C (135°F)
8
for more than 120 minutes immediately after the
9
machine is filled, serviced, or restocked.
10
4-204.112
11
(A)
Temperature Measuring Devices.
In a mechanically refrigerated or hot
FOOD
storage unit,
12
the sensor of a
13
located to measure the air temperature or a simulated
14
product temperature in the warmest part of a mechanically
15
refrigerated unit and in the coolest part of a hot
16
storage unit.
17
(B)
TEMPERATURE MEASURING DEVICE
shall be
FOOD
Except as specified in ¶ (C) of this section, cold or hot
18
holding
19
(TIME/TEMPERATURE
20
designed to include and shall be equipped with at least
21
one integral or permanently affixed
22
23
DEVICE
EQUIPMENT
used for
POTENTIALLY HAZARDOUS FOOD
CONTROL FOR SAFETY FOOD)
shall be
TEMPERATURE MEASURING
that is located to allow easy viewing of
device's temperature display.
162
the
1
(C)
Paragraph
(B)
of
this
section
does not
2
EQUIPMENT
3
MEASURING DEVICE
4
the ambient
5
design, type, and use of the
6
units, heat lamps, cold plates, bainmaries, steam tables,
7
insulated
8
(D)
9
10
for which the placement of a
07.10.13
apply to
TEMPERATURE
is not a practical means for measuring
FOOD
because of the
EQUIPMENT,
such as cal rod
air surrounding the
FOOD
TEMPERATURE
transport containers, and salad bars.
shall be designed to be
MEASURING DEVICES
easily readable.
(E)
11
FOOD
TEMPERATURE
MEASURING
TEMPERATURE MEASURING DEVICES
on
DEVICES
and
WAREWASHING
water
machines
12
shall have a numerical scale, printed record, or digital
13
readout in increments no greater than 1oC or 2oF in the
14
intended range of use.
15
4-204.113
16
Warewashing Machine, Data Plate Operating
Specifications.
17
A WAREWASHING machine shall be provided with an easily accessible
18
and
19
manufacturer that indicates the machine’s design and operation
20
specifications including the:
21
(A)
22
23
readable
data
Temperatures
plate
affixed
required
for
to
the
machine
washing,
by the
rinsing,
and
SANITIZING;
(B)
Pressure required for the fresh water
163
SANITIZING rinse unless
07.10.13
1
the machine is designed to use only a pumped
2
rinse; and
3
(C)
4
SANITIZING
Convey or speed for convey or machines or cycle time for
stationary rack machines.
5
4-204.114
6
WAREWASHING machine
7
equipped with baffles, curtains, or other means to minimize
8
internal cross contamination of the solutions in wash and rinse
9
tanks.
10
4-204.115
11
Warewashing Machines, Internal Baffles.
wash
and
rinse tanks shall be
Warewashing Machines, Temperature Measuring
Devices.
12
A WAREWASHING machine shall be equipped with a
13
MEASURING DEVICE
14
(A)
In each wash and rinse tank; and
15
(B)
As the water enters the hot water SANITIZING final rinse manifold
16
17
that indicates the temperature of the water:
or in the chemical
4-204.116
18
TEMPERATURE
SANITIZING
solution tank.
Manual Warewashing Equipment, Heaters and
Baskets.
19
If hot water is used for
SANITIZATION
20
operations, the
compartment of the sink shall be:
21
(A)
SANITIZING
in manual
WAREWASHING
Designed with an integral heating device that is capable of
22
maintaining water at a temperature not less than 77oC
23
(171oF); and
164
1
(B)
07.10.13
Provided with a rack or basket to allow complete
2
immersion of
3
water.
4
4-204.117
5
equipment
and
utensils
into
the hot
Warewashing Machines, Automatic Dispensing of
Detergents and Sanitizers.
6
A
7
Code by the
8
(A)
Automatically dispense detergents and
9
(B)
Incorporate a visual means to verify that detergents and
WAREWASHING
machine that is installed after adoption of this
REGULATORY AUTHORITY,
10
SANITIZERS
11
signal if the detergents and
12
the respective washing and
13
4-204.118
14
(A)
shall be equipped to:
SANITIZERS;
and
are delivered or a visual or audible alarm to
SANITIZERS
are not delivered to
SANITIZING
cycles.
Warewashing Machines, Flow Pressure Device.
WAREWASHING machines that provide a fresh hot water
15
SANITIZING
16
or similar device such as a transducer that measures
17
and displays the water pressure in the supply line immediately
18
before entering the
19
(B)
rinse shall be equipped with a pressure gauge
WAREWASHING
machine; and
If the flow pressure measuring device is upstream of the
20
fresh hot water
21
shall be mounted in a 6.4 millimeter or one-fourth inch
22
Iron Pipe Size (IPS) valve.
23
(C)
SANITIZING
rinse control valve, the device
Paragraphs (A) and (B) of this section do not apply to a
165
1
machine
that
uses
2
SANITIZING
rinse.
only
a
pumped
or
07.10.13
recirculated
3
4-204.119
Warewashing Sinks and Drain boards, Self Draining.
4
Sinks and drain boards of
5
be self-draining.
6
4-204.120
7
EQUIPMENT compartments that are subject to accumulation of moisture
8
due to conditions such as condensation,
9
or water from melting ice shall be sloped to an outlet that
WAREWASHING
sinks and machines shall
Equipment Compartments, Drainage.
10
allows complete draining.
11
4-204.121
12
(A)
FOOD
or
BEVERAGE
drip,
Vending Machines, Liquid Waste Products.
VENDING
designed to store
MACHINES
BEVERAGES
that are
13
PACKAGED
14
be equipped with diversion devices and retention pans
15
or drains for container leakage.
16
(B)
VENDING
17
shall be:
18
(1)
in containers made from paper products shall
MACHINES
Provided
that dispense liquid
with
an
internally mounted
19
receptacle for
20
overflow, or other internal wastes; and
21
(2)
the
FOOD
collection
of
drip,
in
bulk
waste
spillage,
Equipped with an automatic shutoff device that will
22
place the machine out of operation before the
23
waste receptacle overflows.
166
1
(C)
07.10.13
Shutoff devices specified under Subparagraph (B)(2) of this
2
section shall prevent water or liquid
3
running if there is a failure of a flow control device in
4
the water or liquid
5
that could lead to overflow of the waste receptacle.
FOOD
FOOD
from continuously
system or waste accumulation
6
4-204.122
Case Lot Handling Apparatuses, Moveability.
7
Apparatuses, such as dollies, pallets, racks, and skids used to
8
store
9
received from a supplier in a cased or overwrapped lot, shall
and transport
large quantities of
PACKAGED
10
be designed to be moved by hand
or
11
available apparatuses such as hand trucks and forklifts.
12
4-204.123
13
(A)
FOODS
by conveniently
Vending Machine Doors and Openings.
VENDING
MACHINE
doors and access opening covers to
14
FOOD
and container storage spaces shall be tight-fitting
15
so that the space along the entire interface between the
16
doors or covers and the cabinet of the machine, if the
17
doors or covers are in a closed position, is no greater
18
than 1.5 millimeters or one-sixteenth inch by:
19
(1)
Being
covered
with
louvers,
screens,
or
20
materials that provide an equivalent opening of not
21
greater than 1.5 millimeters or one-sixteenth inch.
22
Screening
23
centimeters
167
of
12
(12
or
mesh
more
to
1
mesh
inch)
to
2.5
meets
this
07.10.13
1
requirement;
2
(2)
Being effectively gasketed;
3
(3)
Having interface surfaces that are at least 13 millimeters
4
or one-half inch wide; or
5
(4)
6
Jambs or surfaces used to form an L-shaped entry
path to the interface.
(B)
7
VENDING
MACHINE
service
connection openings through
8
an exterior wall
9
sealants, clamps, or grommets so that the openings are
10
11
of a machine shall be closed by
no larger than 1.5 millimeters or one-sixteenth inch.
Acceptability
4-205.10
Food Equipment, Certification and Classification.
12
FOOD
13
an American
14
certification program is deemed to comply with Parts 4-1 and 4-2
15
of this chapter.
16
4-3
17
EQUIPMENT
that is certified or classified for sanitation by
National
Standards
Institute (ANSI) accredited
NUMBERS AND CAPACITIES
Subparts
18
4-301
Equipment
19
4-302
Utensils, Temperature Measuring Devices, and
20
Testing Devices
21
22
23
Equipment
4-301.11
Cooling, Heating, and Holding Capacities.
EQUIPMENT for cooling and heating
168
FOOD,
and holding cold and
1
2
3
hot
FOOD,
FOOD
temperatures as specified under Chapter 3.
4-301.12
4
5
07.10.13
shall be sufficient in number and capacity to provide
Manual
Warewashing,
Sink
Compartment
Requirements.
(A)
Except as specified in ¶ (C) of this section, a sink with
6
at least 3 compartments shall be provided for manually
7
washing, rinsing, and
8
(B)
9
SANITIZING EQUIPMENT
and
UTENSILS.
Sink compartments shall be large enough to accommodate
immersion of the largest
UTENSILS.
10
EQUIPMENT
11
sink, a
12
as specified in ¶ (C) of this section shall be used.
UTENSILS
WAREWASHING
If
are too large for the WAREWASHING
machine or alternative
EQUIPMENT
Alternative
manual
14
used when
there
15
constraints and its use is
16
WAREWASHING EQUIPMENT
17
(1)
High-pressure detergent sprayers;
18
(2)
Low- or line-pressure spray detergent foamers;
19
(3)
Other task-specific cleaning
20
(4)
Brushes or other implements;
21
(5)
2-compartment sinks as specified under ¶¶ (D) and
13
(C)
or
and
EQUIPMENT
22
23
WAREWASHING
are
EQUIPMENT
special
cleaning
APPROVED.
may be
needs
or
Alternative manual
may include:
EQUIPMENT;
(E) of this section; or
(6)
Receptacles that substitute for the compartments
169
07.10.13
1
2
of a multicompartment sink.
(D)
Before a 2-compartment sink is used:
(1)
3
4
The
PERMIT HOLDER
shall have its use
APPROVED;
and
5
(2)
The
PERMIT
HOLDER
shall limit the number of
6
KITCHENWARE
7
2-compartment sink, and shall limit
8
batch operations for cleaning
9
as between
10
another
11
shall:
12
(a)
items cleaned and
raw
to
such
MEAT
and
the end of a shift, and
Make up the cleaning and
SANITIZING
immediately before
14
immediately after use, and
(b)
WAREWASHING
cutting one type of
or cleanup at
in the
KITCHENWARE
13
15
SANITIZED
solutions
use and drain them
Use a detergent-SANITIZER to
SANITIZE
and
16
apply the detergent-SANITIZER in accordance with
17
the manufacturer’s label instructions and as
18
specified under § 4-501.115, or
(c)
19
20
21
Use a hot water SANITIZATION immersion step as
specified under ¶ 4-603.16(C).
(E)
A 2-compartment sink shall not be used for
22
operations where cleaning and
23
for a continuous or intermittent flow of
170
SANITIZING
WAREWASHING
solutions are used
KITCHENWARE
or
07.10.13
1
TABLEWARE
in an ongoing
WAREWASHING
process.
2
4-301.13
Drain boards.
3
Drain boards,
4
accommodate all soiled and cleaned items that may accumulate
5
during hours of operation shall be provided for necessary
UTENSIL
racks, or tables large
holding before cleaning and after
enough
to
6
UTENSIL
7
4-301.14
8
Ventilation hood systems and devices shall be sufficient in number
9
and capacity to prevent grease or condensation from collecting on
Ventilation Hood Systems, Adequacy.
10
walls and ceilings.
11
4-301.15
12
(A)
SANITIZING.
Clothes Washers and Dryers.
Except
as specified in ¶ (B) of this section, if work
13
clothes or LINENS are laundered on the PREMISES, a mechanical
14
clothes washer and dryer shall be provided and used.
15
(B)
If on-PREMISES laundering is limited to wiping cloths intended
16
to be used moist, or wiping cloths are air-dried as
17
specified under § 4-901.12, a mechanical clothes washer
18
and dryer need not be provided.
19
Utensils,
4-302.11
20
Temperature
A
21
Measuring
container displayed at a
22
Devices,
buffet or salad bar.
FOOD
Utensils, Consumer Self-Service.
dispensing
UTENSIL
171
shall
CONSUMER
be
available for each
self-service unit such as a
07.10.13
1
and Testing
2
Devices
3
4-302.12
4
(A)
Food Temperature Measuring Devices.
FOOD
TEMPERATURE
MEASURING
shall
DEVICES
be
5
provided and readily accessible for use in ensuring attainment
6
and maintenance of
7
Chapter 3.
8
(B)
A
FOOD
temperatures as specified under
TEMPERATURE MEASURING DEVICE
with a suitable small-
9
diameter probe that is designed to measure the temperature
10
of thin masses shall be provided and readily accessible
11
to accurately measure the temperature in thin
12
as
13
4-302.13
14
MEAT
patties and
Temperature
such
filets.
Measuring
Devices,
Manual
Warewashing.
15
In manual
16
DEVICE
17
measuring the washing and
18
4-302.14
19
A
20
concentration in
21
provided.
WAREWASHING
operations, a
4-4
TEMPERATURE MEASURING
shall be provided and readily accessible for frequently
SANITIZING
temperatures.
Sanitizing Solutions, Testing Devices.
test kit or other device that
MG/L
of
22
23
FISH
FOODS
LOCATION AND INSTALLATION
172
accurately measures the
SANITIZING
solutions
shall
be
07.10.13
1
Subparts
2
4-401
Location
3
4-402
Installation
4-401.11
Equipment, Clothes Washers and Dryers, and
4
5
Location
6
7
Storage Cabinets, Contamination Prevention.
(A)
Except as specified in ¶ (B) of this section,
a
8
cabinet used for the storage of
9
is used to store cleaned and SANITIZED EQUIPMENT, UTENSILS,
10
laundered
LINENS,
and
FOOD,
EQUIPMENT,
or a cabinet that
SINGLE-SERVICE
and
SINGLE-USE
11
ARTICLES
12
(1)
In locker rooms;
13
(2)
In toilet rooms;
14
(3)
In garbage rooms;
15
(4)
In mechanical rooms;
16
(5)
Under sewer lines that are not shielded to intercept
17
18
shall not be located:
potential drips;
(6)
Under leaking water lines including leaking automatic
19
fire sprinkler heads or under lines on which water
20
has condensed;
21
(7)
Under open stairwells; or
22
(8)
Under other sources of contamination.
173
(B)
1
2
A
storage cabinet used for
SINGLE-USE ARTICLES
3
(C)
LINENS
or
07.10.13
or
SINGLE-SERVICE
may be stored in a locker room.
If a mechanical clothes washer or dryer is provided, it
4
shall be located so that
5
protected from contamination and only where there is no
6
exposed
7
and unwrapped
8
9
Installation
4-402.11
(A)
FOOD;
clean
the
washer
EQUIPMENT, UTENSILS,
SINGLE-SERVICE
and
shall be installed so that it is:
11
(1)
EASILY MOVABLE
Spaced to allow access for cleaning along the
sides, behind, and above the
(2)
LINENS;
Fixed Equipment, Spacing or Sealing.
10
13
and
SINGLE-USE ARTICLES.
EQUIPMENT that is fixed because it is not
12
or dryer is
Spaced from adjoining
EQUIPMENT;
EQUIPMENT,
walls, and ceilings
14
a distance of not more than 1 millimeter or one
15
thirty-second inch; or
16
(3)
17
18
SEALED to adjoining
EQUIPMENT
(B)
COUNTER-MOUNTED
EQUIPMENT
or walls, if the
is exposed to spillage or seepage.
EQUIPMENT
that is not
EASILY MOVABLE
19
shall be installed to allow cleaning of the
20
areas underneath and around the
21
(1)
SEALED; or
22
(2)
Elevated on legs as specified under ¶ 4-402.12(D).
23
4-402.12
EQUIPMENT
EQUIPMENT
by being:
Fixed Equipment, Elevation or Sealing.
174
and
1
(A)
07.10.13
Except as specified in ¶¶ (B) and (C) of this section, floor-
2
mounted
3
SEALED
4
least a 15 centimeter (6 inch) clearance between the floor
5
and the
6
(B)
EQUIPMENT
that is not
EASILY MOVABLE
shall be
to the floor or elevated on legs that provide at
EQUIPMENT.
If no part of the floor under the floor-mounted
EQUIPMENT
7
is more than 15 centimeters (6 inches) from the point of
8
cleaning access, the clearance space may be only 10
9
centimeters (4 inches).
10
(C)
This section does not apply to display shelving units, display
11
refrigeration units, and display freezer units located in the
12
CONSUMER
13
floor under the units is maintained clean.
14
(D)
shopping areas of a retail
FOOD
store, if the
Except as specified in ¶ (E) of this section,
15
MOUNTED EQUIPMENT
16
elevated on legs that provide at least a 10 centimeter (4
17
inch) clearance between the table and the
18
(E)
The
that is not
COUNTER-
EASILY MOVABLE
EQUIPMENT.
clearance space between the table and
19
MOUNTED EQUIPMENT
20
(1)
7.5
shall be
COUNTER-
may be:
centimeters
(3 inches)
if
the
horizontal
21
distance of the table top under the
22
no more than 50 centimeters (20 inches) from the
23
point of access for cleaning; or
175
EQUIPMENT
is
1
(2)
07.10.13
5 centimeters (2 inches) if the horizontal distance
2
of the table top under the
3
than 7.5 centimeters (3 inches ) from the point of
4
access for cleaning.
EQUIPMENT
is no more
5
6
4-5
7
MAINTENANCE AND OPERATION
Subparts
8
4-501
Equipment
9
4-502
Utensils and Temperature and Pressure
10
Measuring Devices
11
12
13
Equipment
4-501.11
(A)
Good Repair and Proper Adjustment.
EQUIPMENT
shall be maintained in a state of repair and
14
condition that
15
Parts 4-1 and 4-2.
16
(B)
meets the requirements specified under
EQUIPMENT components such as doors, seals, hinges,
17
fasteners, and kick plates shall be kept intact, tight, and
18
adjusted in accordance with manufacturer's specifications.
19
20
(C)
Cutting or piercing parts of can openers shall be kept
21
sharp to minimize the creation of metal fragments that
22
can contaminate
FOOD
176
when the container is opened.
07.10.13
1
4-501.12
Cutting Surfaces.
2
Surfaces such as cutting blocks and boards that are subject
3
to scratching and scoring shall be resurfaced if they can no
4
longer be effectively cleaned and
5
are not capable of being resurfaced.
6
4-501.13
7
Microwave ovens shall meet the safety standards specified in
8
21 CFR 1030.10 Microwave ovens.
9
4-501.14
SANITIZED,
or discarded if they
Microwave Ovens.
Warewashing Equipment, Cleaning Frequency.
10
A
11
or other receptacles used for washing and rinsing
WAREWASHING
machine; the compartments of sinks, basins,
12
UTENSILS,
13
boards or other
14
as specified under § 4-301.13 shall be cleaned:
15
(A)
16
(B)
or raw
FOODS,
or laundering wiping cloths; and drain
EQUIPMENT
used to substitute for drain boards
Before use;
Throughout
the day at
a
17
prevent recontamination of
18
to ensure
19
function; and
20
(C)
21
4-501.15
that the
frequency necessary to
EQUIPMENT
EQUIPMENT
and
UTENSILS
and
performs its intended
If used, at least every 24 hours.
22
23
EQUIPMENT,
Warewashing
Machines,
Manufacturers'
Operating Instructions.
(A)
A
WAREWASHING
machine and its auxiliary components shall
177
1
07.10.13
be operated in accordance with the machine's data plate
2
and other manufacturer's instructions.
3
(B)
A
WAREWASHING
machine's conveyor speed or automatic
4
cycle
5
accordance with manufacturer's specifications.
6
4-501.16
7
(A)
A
8
9
times shall be maintained accurately timed in
Warewashing Sinks, Use Limitation.
WAREWASHING
sink shall not be used for handwashing
as specified under § 2-301.15.
(B)
If a
WAREWASHING
sink is used to wash wiping cloths,
10
wash produce, or thaw
11
as specified under § 4-501.14 before and after each time
12
it is used to wash wiping cloths or wash produce or
13
thaw
14
SANITIZED
15
using the sink to wash produce or thaw
FOOD.
FOOD,
the sink shall be cleaned
Sinks used to wash or thaw
FOOD
shall be
as specified under Part 4-7 before and after
FOOD.
16
4-501.17
Warewashing Equipment, Cleaning Agents.
17
When used for
18
mechanical
19
manual
20
shall
21
cleaner, alkaline cleaner, degreaser, abrasive cleaner, or other
22
cleaning agent according to the cleaning agent manufacturer's
23
label instructions.
WAREWASHING,
warewasher,
or
the wash compartment of a sink,
wash
WAREWASHING EQUIPMENT
contain a wash solution
178
receptacle
of alternative
as specified in ¶ 4-301.12(C),
of
soap, detergent,
acid
07.10.13
Warewashing Equipment, Clean Solutions.
1
4-501.18
2
The wash, rinse, and
SANITIZE
solutions shall be maintained clean.
3
4
4-501.19
5
Manual Warewashing Equipment, Wash Solution
Temperature.
6
The temperature of the wash solution in manual
7
EQUIPMENT
8
or the temperature specified on the cleaning agent manufacturer's
9
label instructions.
10
4-501.110
11
12
shall be maintained at not less than 43oC (110oF)
Mechanical
Warewashing
Equipment,
A)
The temperature of the wash solution in spray type
warewashers that use hot water to
14
be less than:
15
(1)
(2)
(3)
For a stationary rack, single temperature machine,
For a stationary rack, dual temperature machine,
For a single tank, conveyor, dual
temperature
machine, 71oC (160oF); or
20
22
shall not
66oC (150oF);
18
21
SANITIZE
74oC (165oF);
16
19
Wash
Solution Temperature.
13
17
WAREWASHING
(4)
For
a
multitank,
conveyor,
machine, 66oC (150oF).
179
multitemperature
1
(B)
07.10.13
The temperature of the wash solution in spray-type
2
warewashers that use chemicals to
3
be less than 49oC (120oF).
4
4-501.111 Manual
5
SANITIZE
shall not
Warewashing Equipment, Hot
Water
Sanitization Temperatures.*
6
If immersion in hot water is used for
7
operation, the temperature of the water shall be maintained
8
at 77oC (171oF) or above.
9
4-501.112
10
11
SANITIZING
in a manual
Mechanical Warewashing Equipment, Hot Water
Sanitization Temperatures.
(A)
Except as specified in ¶(B) of this section, in a mechanical
12
operation, the temperature of the fresh hot water SANITIZING
13
rinse as it enters the manifold shall not be more than
14
90oC, (194oF), or less than:
15
(1)
74oC (165oF); or
16
17
18
For a stationary rack, single temperature machine,
(2)
(B)
For all other machines, 82oC (180oF).
The maximum temperature specified under ¶ (A) of this
19
section,
does
not
apply
to the high pressure and
20
temperature systems with wand-type, hand-held, spraying
21
devices used
22
EQUIPMENT
for the in-place cleaning and
such as meat saws.
180
SANITIZING
of
1
07.10.13
Mechanical Warewashing Equipment, Sanitization
4-501.113
2
Pressure.
3
The flow pressure of the fresh hot water
4
WAREWASHING machine,
5
downstream or upstream from the fresh hot water
6
control value, shall be within the range specified on the machine
7
manufacturer's data plate
8
kilopascals (5 pounds per square inch) or more than
9
kilopascals (30 pounds per square inch).
10
4-501.114
SANITIZING
rinse in a
as measured in the water line immediately
and
SANITIZING
rinse
shall not be less than 35
200
Manual and Mechanical Warewashing Equipment,
11
Chemical
12
Concentration, and Hardness.*
chemical
Sanitization
in
a
Temperature,
pH,
13
A
14
manual or mechanical operation at exposure times specified under
15
¶ 4-703.11(C) shall meet the criteria specified under § 7-204.11
16
Sanitizers, Criteria, shall be used in accordance
17
approved
18
used as follows:
19
(A)
SANITIZER
used
-
SANITZING
solution for a
with the EPA-
manufacturer's label use instructions, and shall be
A chlorine solution shall have a minimum temperature
20
based on the concentration and
21
listed in the following chart;
PH
of the solution as
22
23
24
Minimum
Concentration
181
Minimum Temperature
07.10.13
1
2
3
4
MG/L
PH
PH
o
5
10 or less
C (oF)
o
8 or less
C (oF)
25
49 (120)
49 (120)
6
50
38 (100)
24 ( 75)
7
100
13 ( 55)
13 ( 55)
8
9
(B)
An iodine solution shall have a:
10
(1)
Minimum temperature of 24oC (75oF),
11
(2)
PH
of 5.0 or less or a
PH
no higher than the level
12
for which the manufacturer specifies the solution is
13
effective, and
14
15
(3)
(C)
Concentration between 12.5 MG/L and 25 MG/L;
A quaternary ammonium compound solution shall:
16
(1)
Have a minimum temperature of 24oC (75oF),
17
(2)
Have a concentration as specified under § 7-204.11
18
and
19
directions included in the labeling, and
20
(3)
as
indicated
by
the
manufacturer's use
Be used only in water with 500 MG/L hardness or
21
less or
22
than specified by the manufacturer's label;
23
24
(D)
in water having a hardness no greater
If another solution of a chemical specified under ¶¶ (A) (C)
of
this
section
182
is
used,
the
PERMIT
HOLDER
shall
1
demonstrate
2
solution
3
solution shall be
4
(E)
to
the
achieves
If a chemical
REGULATORY
SANITIZATION
APPROVED;
SANITIZER
07.10.13
that the
AUTHORITY
and the use of
the
or
other than chlorine, iodine, or a
5
quaternary ammonium compound is used, it shall be
6
applied
7
directions included in the labeling.
8
4-501.115
in accordance
Manual
9
with
the
Warewashing
manufacturer’s
Equipment,
use
Chemical
Sanitization Using Detergent-Sanitizers.
10
If a detergent-SANITIZER is used to
11
SANITIZING
12
SANITIZE
in a cleaning and
procedure where there is no distinct water rinse between
the washing and
SANITIZING
13
SANITIZING
step shall
14
used in the washing step.
15
4-501.116
16
steps, the agent applied in the
be the same detergent-SANITIZER that is
Warewashing Equipment, Determining
Chemical Sanitizer Concentration.
17
Concentration of the
18
determined by using a test kit or other device.
SANITIZING
solution shall be accurately
19
Utensils and
4-502.11
20
Temperature
(A)
21
and Pressure
condition that
22
Measuring
under Parts 4-1 and 4-2 or shall be discarded.
23
Devices
(B)
Good Repair and Calibration.
UTENSILS shall be maintained in a state of repair or
FOOD
complies with the requirements specified
TEMPERATURE MEASURING DEVICES
183
shall be calibrated
07.10.13
with manufacturer's specifications as
1
in
2
necessary to ensure their accuracy.
3
(C)
accordance
Ambient air temperature, water pressure, and water
4
TEMPERATURE MEASURING DEVICES
5
good
6
range of use.
7
repair
4-502.12
accurate
within
the intended
Use.*
9
A
10
6
11
TABLEWARE
12
SERVICE ARTICLES,
13
EMPLOYEES
14
CONSUMERS.
15
4-502.13
FOOD ESTABLISHMENT
and 4-7
16
for
without facilities specified under Parts 4-
cleaning
shall provide only
AND
and
and
SANITIZING KITCHENWARE
and
SINGLE-USE KITCHENWARE, SINGLE-
SINGLE-USE ARTICLES
SINGLE-SERVICE
for use by
for
ARTICLES
FOOD
use
by
Single-Service and Single-Use Articles, Use
Limitation.
(A)
18
19
be
Single-Service and Single-Use Articles, Required
8
17
and
shall be maintained in
SINGLE-SERVICE and
SINGLE-USE ARTICLES
shall
not
be
reused.
(B)
The bulk milk container dispensing tube shall be cut
20
on
21
protruding from the chilled dispensing head.
22
4-502.14
23
Mollusk
the
diagonal
leaving
no
more
than
one
inch
Shells, Use Limitation.
and
crustacea shells shall not be used more than
184
07.10.13
1
once as serving containers.
2
3
4-6
4
CLEANING OF EQUIPMENT AND UTENSILS
Subparts
5
4-601
Objective
6
4-602
Frequency
7
4-603
Methods
4-601.11
Equipment,
8
9
Objective
10
Food-Contact
Surfaces,
Nonfood-
Contact Surfaces, and Utensils.*
(A)
11
12
EQUIPMENT
FOOD-CONTACT SURFACES
and
UTENSILS
shall
EQUIPMENT
and
be clean to sight and touch.
13
(B)
The
FOOD-CONTACT SURFACES
of cooking
14
pans shall be kept free of encrusted grease deposits and
15
other soil accumulations.N
16
(C)
NonFOOD-CONTACT
SURFACES
of
EQUIPMENT
17
free of an accumulation of dust, dirt,
18
other debris.N
19
Frequency
4-602.11
20
21
Equipment
shall be kept
FOOD
Food-Contact
residue, and
Surfaces
and
Utensils.*
(A)
EQUIPMENT
22
cleaned:
23
(1)
FOOD-CONTACT SURFACES
and
UTENSILS
shall be
Except as specified in ¶ (B) of this section, before each
185
1
use with a different type of raw animal
2
as beef,
3
(2)
4
Each
raw
5
(3)
FISH,
lamb, pork, or
FOODS
to working with
Between uses
7
(TIME/TEMPERATURE
9
Before
(5)
11
At
READY-TO-EAT FOODS;
fruits
POTENTIALLY
during
FOOD
the
TEMPERATURE
operation
when
contamination may have occurred.
(B)
Subparagraph (A)(1) of this section does not apply if the
FOOD-CONTACT SURFACE
14
succession of different raw animal
15
a
higher
cooking
16
§3-401.11
17
raw
18
cutting board.
(C)
FISH
or
UTENSIL
temperature
than the previous
FOODS
as
FOOD,
each requiring
specified
under
such as preparing
Except as specified in ¶ (D) of this section, if used with
POTENTIALLY HAZARDOUS FOOD
21
FOR SAFETY FOOD),
22
and
23
least every 4 hours.
(D)
is in contact with a
followed by cutting raw poultry on the same
20
24
FOOD
and
13
19
vegetables
HAZARDOUS
using or storing a
any time
and
CONTROL FOR SAFETY FOOD);
MEASURING DEVICE;
10
12
with
with raw
and
(4)
POULTRY;
time there is a change from working with
6
8
07.10.13
such
FOOD
UTENSILS
Surfaces
of
(TIME/TEMPERATURE
EQUIPMENT FOOD-CONTACT SURFACES
shall be cleaned
UTENSILS
186
CONTROL
and
throughout the day at
EQUIPMENT
contacting
07.10.13
1
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL
2
FOR SAFETY FOOD)
3
every 4 hours if:
4
(1)
may be cleaned less frequently than
In storage, containers of
POTENTIALLY HAZARDOUS
5
FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD)
6
and their contents are maintained
7
specified under Chapter 3 and the containers are
8
cleaned when they are empty;
9
(2)
and
UTENSILS
in
a
EQUIPMENT
are used to prepare
10
FOOD
11
maintained at one of the temperatures in the
12
following chart and:
13
(a)
The
refrigerated
at temperatures
UTENSILS
and
or
EQUIPMENT
the
area
the frequency
15
corresponds to the temperature; and
following chart
Temperature
Cleaning
Frequency
5.0oC (41oF) or less
24 hours
21
22
>5.0oC - 7.2oC
(>41oF - 45oF)
20 hours
23
24
>7.2oC - 10.0oC
(>45oF - 50oF)
16 hours
25
26
27
>10.0oC - 12.8oC
(>50oF - 55oF)
10 hours
187
that
is
are cleaned at
14
16
17
18
19
20
in
room
that
07.10.13
1
2
(b)
The
cleaning
frequency
based
on
the
3
ambient temperature of the refrigerated room
4
or area is documented
5
ESTABLISHMENT.
6
(3)
Containers in serving
in
the
situations such as salad
7
bars, delis, and cafeteria lines hold
8
POTENTIALLY
9
CONTROL FOR SAFETY FOOD)
HAZARDOUS
FOOD
FOOD
READY-TO-EAT
(TIME/TEMPERATURE
that
is maintained at
10
the temperatures specified under
11
intermittently combined with additional supplies of
12
the same
13
and the containers are cleaned at least every 24
14
hours;
FOOD
188
Chapter 3, are
that is at the required temperature,
1
(4)
TEMPERATURE
MEASURING DEVICES
2
contact with
3
of deli
4
specified under Chapter 3;
5
(5)
EQUIPMENT is used for storage of
unpackaged
7
and
8
necessary
9
residues;
(6)
such as when left in a container
or in a roast, held at temperatures
FOOD
6
10
FOOD,
07.10.13
are maintained in
the
FOOD
such as a reach-in refrigerator
EQUIPMENT
to
is cleaned at a frequency
preclude
accumulation
The cleaning schedule is
11
consideration of:
12
(a)
Characteristics of the
13
(b)
The type of
14
(c)
The amount of
15
or
PACKAGED
FOOD
APPROVED
EQUIPMENT
of
soil
based on
and its use,
involved,
FOOD
residue accumulation,
and
(d)
16
The
temperature at which the
FOOD
is
17
maintained during the operation and the potential
18
for the rapid and progressive multiplication of
19
pathogenic or toxigenic microorganisms that are
20
capable of causing foodborne disease; or
21
(7)
In-use
UTENSILS
are
intermittently
stored in a
22
container of water in which the water is maintained
23
at
24
container are cleaned at least every 24 hours
189
57oC (135oF) or more and the
UTENSILS
and
1
or
2
accumulation of soil residues.
3
(E)
at
a
frequency
necessary
to
07.10.13
preclude
Except when dry cleaning methods are used as specified
4
under § 4-603.11, surfaces of
5
contacting
6
(TIME/TEMPERATURE
7
cleaned:N
8
(1)
At any time when contamination may have occurred;
9
(2)
At least every 24 hours for iced tea dispensers
that is not
FOOD
and
11
tongs, scoops, or ladles;
(3)
CONSUMER
UTENSILS
14
containers; and
(4)
EQUIPMENT
POTENTIALLY HAZARDOUS
self-service
UTENSILS
shall
such
be
as
Before restocking CONSUMER self-service EQUIPMENT and
13
15
and
CONTROL FOR SAFETY FOOD)
10
12
UTENSILS
In
such as condiment dispensers and display
EQUIPMENT
such as ice bins and
BEVERAGE
16
dispensing nozzles and enclosed components of
17
EQUIPMENT
18
tanks and distribution lines,
19
dispensing lines or tubes, coffee bean grinders, and
20
water vending
21
(a)
22
23
such as ice makers, cooking oil storage
BEVERAGE
and syrup
EQUIPMENT:
At a frequency specified by the manufacturer,
or
(b)
Absent
190
manufacturer
specifications,
at
a
1
frequency
necessary
2
accumulation of soil or mold.
3
4-602.12
Cooking and Baking Equipment.
4
(A)
FOOD-CONTACT SURFACES
The
EQUIPMENT
6
This section does not apply to hot oil cooking and
7
filtering
8
4-602.11(D)(6).
(B)
be cleaned
of cooking and baking
5
9
shall
07.10.13
preclude
to
at least every 24 hours.
EQUIPMENT if it is cleaned as specified in Subparagraph
The cavities and door seals of microwave ovens shall
10
be cleaned
at
least
every
24
hours
by using the
11
manufacturer's recommended cleaning procedure.
12
4-602.13
13
NonFOOD-CONTACT
14
frequency necessary to preclude accumulation of soil residues.
15
16
Methods
4-603.11
(A)
Nonfood-Contact Surfaces.
of
SURFACES
EQUIPMENT
shall be cleaned at a
Dry Cleaning.
If used, dry cleaning methods such as brushing, scraping,
17
and
18
soiled with
19
HAZARDOUS (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD).
20
21
22
(B)
vacuuming shall
Cleaning
SURFACES
4-603.12
dry
FOOD
EQUIPMENT
contact
only
SURFACES
residues that are not
used in dry cleaning
that are
POTENTIALLY
FOOD-CONTACT
may not be used for any other purpose.
Precleaning.
191
1
(A)
FOOD
debris
on
scrapped
3
receptacle or shall be removed in a
4
with a prewash cycle.
(B)
If
necessary
EQUIPMENT
7
with abrasives.
4-603.13
9
waste
for
6
8
a
and
2
5
over
EQUIPMENT
UTENSILS
disposal
effective
unit
07.10.13
shall be
or
garbage
WAREWASHING machine
cleaning,
UTENSILS
and
shall be preflushed, presoaked, or scrubbed
Loading
of
Soiled
Items,
Warewashing
Machines.
10
Soiled items to be cleaned in a WAREWASHING machine shall be loaded
11
into racks, trays, or baskets or onto conveyors in a position that:
12
(A)
13
cycles; and
14
(B)
15
4-603.14
16
(A)
Exposes the items to the unobstructed spray from all
Allows the items to drain.
Wet Cleaning.
EQUIPMENT
FOOD-CONTACT SURFACES
and
UTENSILS
shall
17
be effectively washed to remove or completely loosen
18
soils
19
necessary
20
containing wetting agent and emulsifiers; acid, alkaline,
21
or
22
pads; high-pressure sprays; or ultrasonic devices.
23
(B)
by
using
such
abrasive
the
as
manual
the
cleaners; hot
or
mechanical
application of
water;
means
detergents
brushes; scouring
The washing procedures selected shall be based on
192
07.10.13
1
the type and purpose of the
2
and on the type of soil to be removed.
3
4-603.15
Washing,
4
Procedures
or
UTENSIL,
Alternative
Manual
EQUIPMENT
for
Warewashing Equipment.
5
If washing in sink compartments or a
6
impractical such as when the
7
UTENSILS
8
alternative manual
9
4-301.12(C) in accordance with the following procedures:
10
(A)
11
12
EQUIPMENT
are too large, washing
machine is
is fixed or
the
shall be done by using
WAREWASHING EQUIPMENT
as specified in ¶
EQUIPMENT shall be disassembled as necessary to allow
access of the detergent solution to all parts;
(B)
EQUIPMENT components and
13
or rough cleaned to remove
14
and
15
WAREWASHING
(C)
16
EQUIPMENT and
UTENSILS
UTENSILS
FOOD
shall be scrapped
particle accumulation;
shall be washed as specified
under ¶ 4-603.14(A).
17
4-603.16
18
Washed
19
abrasives are removed and cleaning chemicals are removed
20
or diluted through the use of water or a detergent-sanitizer
21
solution by using one of the following procedures:
22
(A)
23
Rinsing Procedures.
UTENSILS
and
EQUIPMENT
shall
be
rinsed
so that
Use of a distinct, separate water rinse after washing and
before
SANITIZING
if using:
193
07.10.13
1
(1)
A 3-compartment sink,
2
(2)
Alternative
manual
WAREWASHING
EQUIPMENT
3
equivalent to a 3-compartment sink as specified
4
in ¶ 4-301.12(C), or
(3)
5
A
3-step
6
procedure
7
EQUIPMENT;
8
(B)
9
Use
of
washing,
in
a
a
rinsing,
(1)
Alternative
WAREWASHING EQUIPMENT
12
detergent-sANITIZER, or
13
(2)
(C)
A
WAREWASHING
16
compartment sink operation;
water
If using a
SANITIZATION
for use with a
CIP EQUIPMENT;
WAREWASHING
immersion
the
19
section, or alternative manual
SANITIZING
step
of
a
2-
machine that does not recycle
18
22
as specified in
Use of a nondistinct water rinse that is integrated in the
hot
(D)
APPROVED
system for
15
21
CIP
detergent-SANITIZER as specified under
¶ 4-301.12(C) that is
20
system for
WAREWASHING
11
17
SANITIZING
§ 4-501.115 if using:
10
14
and
solution as specified under ¶ (E) of this
WAREWASHING EQUIPMENT such
as sprayers, use of a nondistinct water rinse that is:
(1)
Integrated in the application of the SANITIZING solution,
and
194
1
2
07.10.13
Wasted immediately after each application; or
(2)
(E)
If
using
a
machine
WAREWASHING
that recycles the
3
SANITIZING
4
of a nondistinct water rinse that is integrated in the
5
application of the
6
4-603.17
7
(A)
8
SANITIZING
solution.
Returnables, Cleaning for Refilling.*
Except as specified in ¶¶ (B) and (C) of this section, returned
empty containers intended for cleaning and refilling with
9
FOOD
10
11
solution for use in the next wash cycle, use
shall be cleaned and refilled in a regulated
FOOD
PROCESSING PLANT.
(B)
A
FOOD-specific
12
at a
13
(1)
container for
FOOD ESTABLISHMENT
Only a
BEVERAGE
may be refilled
BEVERAGES
if:
that is not a POTENTIALLY HAZARDOUS
14
FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD)
15
used as specified under ¶ 3-304.17(A);
16
(2)
is
The design of the container and of the rinsing
17
EQUIPMENT
18
considered together, allow effective cleaning at home
19
or in the
20
(3)
and the nature of the
BEVERAGE,
when
FOOD ESTABLISHMENT;
Facilities
for
21
containers
with fresh,
22
pressure and not recirculated are provided as part
23
of the dispensing system;
195
rinsing
before refilling returned
hot
water
that
is under
(4)
1
The
CONSUMER-owned
07.10.13
container returned to the
2
FOOD ESTABLISHMENT
3
service only to the same
4
(5)
for refilling is refilled for sale or
CONSUMER;
and
The container is refilled by:
5
(a)
An EMPLOYEE of the
FOOD ESTABLISHMENT,
6
(b)
The owner of the container if the
7
system
8
transfer process
9
by the container owner.
(C)
10
11
includes
a
that
BEVERAGE
contamination-free
cannot be bypassed
CONSUMER-owned containers that are not
be filled at a water
or
VENDING MACHINE
FOOD-specific may
or system.
12
13
4-7
14
SANITIZATION OF EQUIPMENT AND UTENSILS
Subparts
15
4-701
Objective
16
4-702
Frequency
17
4-703
Methods
4-701.10
Food-Contact Surfaces and Utensils.
18
19
Objective
20
EQUIPMENT
21
SANITIZED.
22
Frequency
4-702.11
FOOD-CONTACT
SURFACES
and
Before Use After Cleaning.*
196
UTENSILS
shall
be
1
UTENSILS and
2
SANITIZED
3
Methods
FOOD-CONTACT SURFACES
Hot Water and Chemical.*
4
After being cleaned,
5
UTENSILS
6
(A)
8
07.10.13
shall be
EQUIPMENT
before use after cleaning.
4-703.11
7
of
shall be
EQUIPMENT FOOD-CONTACT SURFACES
and
in:
SANITIZED
Hot water manual operations by immersion for at least
30 seconds and as specified under § 4-501.111;
(B)
9
Hot water mechanical operations
through
EQUIPMENT
by
being
cycled
that is set up as specified under §§
10
4-501.15, 4-501.112, and 4-501.113 and achieving a
11
UTENSIL
12
measured by an irreversible
13
indicator; or
14
(C)
Chemical
surface
temperature
manual or
application of
the
16
manual
17
methods, using a
18
4-501.114 by providing:
19
(1)
SANITIZING
brushing,
solution
71oC
registering
mechanical
15
swabbing,
of
(160oF)
as
temperature
operations,
including
chemicals by immersion,
or
pressure
spraying
as specified under
§
Except as specified under Subparagraph (C)(2) of
20
this section, an exposure time of at least 10 seconds
21
for a chlorine solution specified under ¶ 4-501.114(A),
22
23
(2)
An exposure time of at least 7 seconds for a
chlorine solution of 50 MG/L that has a
197
PH
of 10
07.10.13
or less and a temperature of at least 38oC (100oF)
1
2
or a
PH
of 8 or less and a temperature of at
least 24oC (75oF),
3
4
(3)
An exposure time of at least 30 seconds for other
5
chemical
6
(4)
SANITIZING
solutions, or
An exposure time used in relationship with a
7
combination of temperature, concentration, and
8
that,
9
SANITIZATION
10
1-201.10(B).
when
evaluated
as
for
defined
efficacy,
in
PH
yields
Subparagraph
11
12
4-8
13
LAUNDERING
Subparts
14
4-801
Objective
15
4-802
Frequency
16
4-803
Methods
4-801.11
Clean Linens.
17
18
Objective
19
Clean
20
soiling matter.
21
22
23
Frequency
LINENS
4-802.11
(A)
shall be free from
FOOD
residues and other
Specifications.
LINENS that do not come in direct contact with
be laundered
FOOD
shall
between operations if they become wet,
198
07.10.13
1
sticky, or visibly soiled.
2
(B)
Cloth gloves used as specified in & 3-304.15(D) shall be
3
laundered before being used with a different type of raw
4
animal
5
(C)
FOOD
such as beef,
FISH,
lamb, pork or
POULTRY.
LINENS and napkins that are used as specified under
6
§ 3-304.13
and
cloth
7
between each use.
napkins
shall
be
laundered
8
(D)
Wet wiping cloths shall be laundered daily.
9
(E)
Dry wiping cloths shall be laundered as necessary to prevent
contamination of
10
11
Methods
4-803.11
and clean serving
FOOD
UTENSILS.
Storage of Soiled Linens.
12
Soiled
13
receptacles or clean, washable laundry bags and stored and
14
transported
to
15
EQUIPMENT,
clean
16
ARTICLES.
17
4-803.12
18
(A)
19
20
LINENS
shall
be
prevent
UTENSILS,
kept
in
clean,
contamination
and
nonabsorbent
of
SINGLE-SERVICE
FOOD,
and
clean
SINGLE-USE
Mechanical Washing.
Except as specified in ¶ (B)
of
this
section,
LINENS
shall be mechanically washed.
(B)
In
FOOD ESTABLISHMENTS
in which only wiping cloths are
21
laundered as specified
22
cloths may be laundered in a mechanical washer, sink
23
designated
only
199
for
in ¶ 4-301.15(B),
laundering
wiping
the wiping
cloths,
or
a
WAREWASHING
2
as specified under § 4-501.14.
3
4-803.13
4
(A)
or
07.10.13
preparation sink that is cleaned
1
FOOD
Use of Laundry Facilities.
Except as specified in ¶ (B) of this section, laundry
5
facilities on the
6
be used only for the washing and drying of items used in
7
the operation of the establishment.
8
(B)
PREMISES
of a
FOOD ESTABLISHMENT
Separate laundry facilities located on the
PREMISES
shall
for the
9
purpose of general laundering such as for institutions
10
providing boarding and lodging may also be used for
11
laundering
FOOD ESTABLISHMENT
items.
12
13
4-9
14
PROTECTION OF CLEAN ITEMS
Subparts
15
4-901
Drying
16
4-902
Lubricating and Reassembling
17
4-903
Storing
18
4-904
Preventing Contamination
4-901.11
Equipment and Utensils, Air-Drying Required.
19
20
Drying
21
After cleaning and
22
(A)
23
SANITIZING, EQUIPMENT
Shall be air-dried or used
after
and
UTENSILS:
adequate draining
as
specified in the first paragraph of 40 CFR 180.940 Tolerance
200
1
07.10.13
exemptions for active and inert ingredients for use in
2
antimicrobial formulations (food-contact surface
3
solutions), before contact with
4
(B)
FOOD;
Shall not be cloth dried except that
SANITIZING
and
UTENSILS
that have
5
been air-dried may be polished with cloths that are maintained
6
clean and dry.
7
4-901.12
Wiping Cloths, Air-Drying Locations.
8
Wiping cloths laundered in a
9
have a mechanical clothes dryer as specified in ¶ 4-301.15(B)
10
shall be air-dried in a location and in a manner that prevents
11
contamination of
12
SERVICE
13
section does not
14
laundering in a
and
FOOD ESTABLISHMENT
that does not
FOOD, EQUIPMENT, UTENSILS, LINENS,
SINGLE-USE ARTICLES
and
and the wiping cloths. This
apply if wiping cloths are stored
SANITIZING
SINGLE-
after
solution as specified under § 4-501.114.
15
16
Lubricating
4-902.11
Food-Contact Surfaces.
17
and
Lubricants as specified under § 7-205.11 shall be applied to
18
Reassembling
FOOD-CONTACT SURFACES
19
does not contaminate
20
4-902.12
21
EQUIPMENT
22
SURFACES
23
Storing
4-903.11
that require lubrication in a manner that
FOOD-CONTACT SURFACES.
Equipment.
shall
be
reassembled
so
that
FOOD-CONTACT
are not contaminated.
Equipment, Utensils, Linens, and Single-Service
201
07.10.13
1
2
and Single-Use Articles.
(A)
Except
as
specified in ¶ (D) of this section, cleaned
3
EQUIPMENT
4
SERVICE
5
(1)
In a clean, dry location;
6
(2)
Where they are not exposed to splash, dust, or
7
and
UTENSILS,
laundered
SINGLE-USE ARTICLES
LINENS,
and
shall be stored:
(B)
(3)
At least 15 cm (6 inches) above the floor.
Clean
EQUIPMENT
and
UTENSILS
shall be stored as specified
10
under ¶ (A) of this section and shall be stored:
11
(1)
In
12
a self-draining position that allows air drying;
and
13
14
SINGLE-
other contamination; and
8
9
and
(2)
(C)
Covered or inverted.
SINGLE-SERVICE and
SINGLE-USE ARTICLES
shall be stored
15
as specified under ¶ (A) of this section and shall be kept
16
in
17
other
18
until used.
19
(D)
the original protective
PACKAGE
or stored by using
means that afford protection from contamination
Items that are kept in closed PACKAGES may be stored less
20
than 15 cm (6 inches) above the floor on dollies, pallets,
21
racks, and skids that are designed as specified under §
22
4-204.122
23
4-903.12
Prohibitions.
202
1
(A)
07.10.13
Except as specified in ¶ (B) of this section, cleaned and
2
SANITIZED
EQUIPMENT,
3
SINGLE-SERVICE
and
UTENSILS,
laundered
SINGLE-USE ARTICLES
LINENS,
and
shall not be stored:
4
5
(1)
In locker rooms;
6
(2)
In toilet rooms;
7
(3)
In garbage rooms;
8
(4)
In mechanical rooms;
9
(5)
Under sewer lines that are not shielded to intercept
10
potential drips;
11
(6)
Under leaking water lines including leaking automatic
12
fire sprinkler heads or under lines on which water
13
has condensed;
14
(7)
Under open stairwells; or
15
(8)
Under other sources of contamination.
16
(B)
Laundered LINENS and SINGLE-SERVICE and SINGLE-USE ARTICLES
17
that are
18
be stored in a locker room.
19
Preventing
4-904.11
20
Contamination
(A)
PACKAGED
or in a facility such as a cabinet may
Kitchenware and Tableware.
SINGLE-SERVICE and
SINGLE-USE ARTICLES
21
SANITIZED
22
dispensed so that contamination of
23
surfaces is prevented.
UTENSILS
203
and cleaned and
shall be handled, displayed, and
FOOD-
and lip-contact
1
(B)
07.10.13
Knives, forks, and spoons that are not prewrapped shall
2
be presented so that only the handles are touched
3
EMPLOYEES
4
provided.
5
(C)
and by
CONSUMERS
if
CONSUMER
self-service is
Except as specified under ¶ (B) of this section,
6
SERVICE ARTICLES
7
shall be furnished for
8
original individual wrapper intact or from an
9
dispenser.
10
4-904.12
self-service with the
CONSUMER
APPROVED
Soiled and Clean Tableware.
Soiled
12
drinking areas and handled so that clean
13
contaminated.
14
4-904.13
15
(A)
17
SINGLE-
that are intended for FOOD- or lip-contact
11
16
by
TABLEWARE
shall be removed from
CONSUMER
eating and
TABLEWARE
is not
Preset Tableware.
TABLEWARE that is preset shall be protected from contamination
by being wrapped, covered, or inverted.
(B)
When
TABLEWARE
is preset, exposed, unused settings shall
18
be:
19
(1)
Removed when a
20
(2)
Cleaned
21
settings
22
seated.
and
are
23
204
CONSUMER
SANITIZED
is seated; or
before further use if the
not removed
when a
CONSUMER
is
07.10.13
1
2
3
4
5
6
7
205
07.10.13
1
Chapter
2
3
3
Parts
Food
4
3-1
CHARACTERISTICS
5
3-2
SOURCES, SPECIFICATIONS, AND ORIGINAL CONTAINERS AND
6
RECORDS
7
3-3
PROTECTION FROM CONTAMINATION AFTER RECEIVING
8
3-4
DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN
9
3-5
LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH
10
CONCERN
11
3-6
FOOD IDENTITY, PRESENTATION, AND ON-PREMISES LABELING
12
3-7
CONTAMINATED FOOD
13
3-8
SPECIAL
14
REQUIREMENTS
FOR
HIGHLY
SUSCEPTIBLE
POPULATIONS
15
16
17
3-1
CHARACTERISTICS
Subparts
18
3-101
Condition
3-101.11
Safe, Unadulterated, and Honestly Presented
19
20
Condition
21
FOOD shall be safe, unADULTERATED, and, as specified under
22
§ 3-601.12, honestly presented.
68
1
07.10.13
SOURCES, SPECIFICATIONS, AND ORIGINAL CONTAINERS AND
3-2
2
3
RECORDS
Subparts
4
3-201
Sources
5
3-202
Specifications for Receiving
6
3-203
Original Containers and Records
3-201.11
Compliance with Food Law.*
7
8
9
Sources
(A)
10
11
LAW.
(B)
12
13
FOOD shall be obtained from sources that comply with
FOOD prepared in a private home shall not be used or
offered for human consumption in a
(C)
PACKAGED
FOOD ESTABLISHMENT.
FOOD shall be labeled as specified in LAW,
including
14
21 CFR 101 FOOD Labeling, 9 CFR 317 Labeling, Marking
15
Devices, and Containers, and 9 CFR 381 Subpart N
16
Labeling and Containers, and as specified under §§
17
3-202.17 and 3-202.18.
18
(D)
Fish, other than
MOLLUSCAN SHELLFISH,
that are intended
19
for consumption in their raw form and allowed as specified
20
in Subparagraph 3-401.11(C)(1) may be offered for sale or
21
service if they are obtained from a supplier that freezes the
22
23
FISH as specified under § 3-402.11; or
frozen on the
PREMISES
as specified under § 3-402.11 and records are retained as
69
07.10.13
1
2
specified under § 3-402.12.
(E)
WHOLE-MUSCLE,
3
consumption
4
CONSUMER
5
(1)
steaks that are intended for
INTACT BEEF
in
an
undercooked
form
without
a
advisory as specified in ¶ 3-401.11(C) shall be:
Obtained from a
FOOD
PROCESSING
that,
PLANT
6
upon request by the purchaser, packages the steaks
7
and labels them, to indicate that the steaks meet the
8
definition of
9
(2)
WHOLE-MUSCLE, INTACT BEEF,
Deemed acceptable by the
or
REGULATORY AUTHORITY
10
based on other evidence, such as written buyer
11
specifications or invoices, that indicates that the steaks
12
meet the definition of
13
and
14
15
(3)
If individually cut in a
(a)
Cut from
WHOLE-MUSCLE, INTACT BEEF,
FOOD ESTABLISHMENT:
WHOLE-MUSCLE INTACT BEEF
that is
16
labeled by a
FOOD
17
specified
Subparagraph
(E)(1) of this
18
section
identified
specified
19
Subparagraph (E)(2) of this section.
in
or
PROCESSING
as
PLANT
20
(b)
Prepared so they remain intact, and
21
(c)
If
PACKAGED
for undercooking in a
22
ESTABLISHMENT,
23
Subparagraph (E)(1)
70
labeled
of
as
this
as
in
FOOD
specified
in
section or
07.10.13
identified as specified in (E)(2) of this section.
1
2
3
(F)
4
MEAT and
is in a
5
POULTRY
PACKAGED
that is not a
and
form when it is offered for sale or otherwise
offered for consumption, shall be labeled to include safe
6
handling instructions as specified in
7
317.2(l) and 9 CFR 381.125(b).
8
READY-TO-EAT FOOD
including 9 CFR
EGGS that have not been specifically treated to destroy
(G)
9
LAW,
all viable Salmonellae shall be labeled to include safe
10
handling instructions as specified in
11
CFR 101.17(h).
LAW,
including 21
12
3-201.12
13
FOOD
14
from a
15
regulatory agency that has jurisdiction over the plant.
16
3-201.13
17
Fluid milk and milk products shall be obtained from sources
18
that comply with
19
3-201.14
20
(A)
in
Food in a Hermetically Sealed Container.*
a
HERMETICALLY SEALED CONTAINER
FOOD PROCESSING PLANT
shall be obtained
that is regulated by the
FOOD
Fluid Milk and Milk Products.*
GRADE A STANDARDS
as specified in
LAW.
Fish.*
FISH that are received for sale or service shall be:
21
(1)
Commercially and legally caught or harvested; or
22
(2)
APPROVED for sale or service.
23
(B)
MOLLUSCAN
SHELLFISH
71
that are recreationally caught shall
07.10.13
1
not be received for sale or service.
2
3-201.15
3
(A)
Molluscan Shellfish.*
MOLLUSCAN
SHELLFISH
shall be obtained from sources
4
according to
5
U.S. Department of Health and Human Services, Public
6
Health Service, Food and Drug Administration, National
7
Shellfish Sanitation Program Guide for the Control of
8
Molluscan Shellfish.
9
(B)
10
MOLLUSCAN
LAW
and the requirements specified in the
SHELLFISH
received in interstate commerce shall
be from sources that are listed in the Interstate Certified
11
Shellfish Shippers List.
12
3-201.16
13
(A)
Wild Mushrooms.*
Except as specified in ¶ (B) of this section, mushroom species
14
picked in the wild shall be obtained from sources where each
15
mushroom is individually inspected and found to be safe
16
by an
17
18
(B)
APPROVED
mushroom identification expert.
This section does not apply to:
(1)
Cultivated wild mushroom species that are grown,
19
harvested, and processed in an operation that is
20
regulated by the
21
jurisdiction over the operation; or
22
23
(2)
FOOD
regulatory agency that has
Wild mushroom species if they are in packaged
form and are the product of a
72
FOOD PROCESSING
PLANT
2
agency that has jurisdiction over the plant.
3
3-201.17
4
(A)
If
FOOD
Game Animals.*
GAME ANIMALS
5
shall be:
6
(1)
7
that is regulated by the
07.10.13
regulatory
1
are received
Commercially raised for
(a)
for sale or service they
FOOD
and:
Raised, slaughtered, and processed under a
8
voluntary inspection program that is conducted
9
by
10
11
the agency that
has animal health
jurisdiction, or
(b)
Under a
routine
inspection
program
12
conducted by a regulatory agency other than
13
the
14
jurisdiction, and
15
(c)
agency
Raised,
that
has
slaughtered,
16
according to:
17
(i)
LAWS governing
animal
and
MEAT
and
health
processed
POULTRY
as
18
determined by the agency that has
19
animal health
20
agency that conducts the inspection
21
program, and
22
(ii)
23
jurisdiction
and
the
Requirements which are developed by
the agency that has animal health
73
jurisdiction
2
conducts the inspection program with
3
consideration of
4
need for antemortem and postmortem
5
examination
6
veterinarian or veterinarian’s designee;
7
(2)
and
the
agency
07.10.13
that
1
factors such as the
by
an
APPROVED
Under a voluntary inspection program administered
8
by the USDA for
9
animals (reindeer,
deer,
that
antelope,
11
APPROVED”
12
animals; voluntary inspection or rabbits that are
13
“inspected and certified” in accordance with 9 CFR
14
354
15
products thereof;
As allowed by
live-caught:
18
(a)
“inspected
and
in accordance with 9 CFR 352 Exotic
voluntary inspection
17
are
water
buffalo,
(3)
bison)
elk,
10
16
or
game animals such as exotic
Under
LAW,
for wild
a
routine
of rabbits and edible
GAME ANIMALS
inspection
that are
program
19
conducted by a regulatory agency such as the
20
agency that has animal health jurisdiction,
21
and
22
23
(b)
Slaughtered and processed according to:
(i)
LAWS governing
74
MEAT
and
POULTRY
as
1
07.10.13
determined by the agency that has
2
animal
3
agency that conducts the inspection
4
program, and
5
(ii)
health jurisdiction and
the
Requirements which are developed by
6
the agency that has animal health
7
jurisdiction
8
conducts the inspection program with
9
consideration of
and the
agency that
factors
such as the
10
need for antemortem and postmortem
11
examination
12
veterinarian or veterinarian’s designee;
13
or
14
(4)
As
allowed
by
LAW,
15
ANIMALS
16
ensures the animals:
17
(a)
APPROVED
for field-dressed wild
GAME
Receive a postmortem examination by an
APPROVED
19
designee, or
(b)
an
under a routine inspection program that
18
20
by
veterinarian
or
veterinarian's
Are field-dressed and transported according
21
to
requirements specified by
22
that has animal health jurisdiction and
23
agency
75
that
conducts
the
the agency
the
inspection
07.10.13
1
program, and
2
(c)
Are processed according to
MEAT
4
agency that has animal health jurisdiction
5
and the agency that conducts the inspection
6
program.
(B)
A
GAME ANIMAL
POULTRY
as
governing
3
7
and
LAWS
determined by the
shall not be received for sale or service if
8
it is a species of wildlife that is listed in 50 CFR 17
9
Endangered and threatened wildlife and plants.
10
Specifications
3-202.11
11
for Receiving
(A)
Temperature.*
Except as specified in ¶ (B) of this section, refrigerated,
12
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL
13
FOR SAFETY FOOD)
14
or below when received.
15
(B)
shall be at a temperature of 5oC (41oF)
If a temperature other than 5°C (41°F) for a
16
HAZARDOUS FOOD
17
FOOD)
is specified in
18
LAWS
governing milk and
19
may be received at the specified temperature.
20
(C)
Raw
EGGS
(TIME/TEMPERATURE
POTENTIALLY
LAW
CONTROL FOR SAFETY
governing its distribution, such as
MOLLUSCAN SHELLFISH,
the
FOOD
shall be received in refrigerated equipment that
21
maintains an ambient air temperature of 7oC (45oF) or
22
less.
23
(D)
POTENTIALLY
HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL
76
07.10.13
that is cooked to a temperature and for
1
FOR SAFETY FOOD)
2
a
3
received hot shall be at a temperature of 57oC (135oF)
4
or above.
5
(E)
A
6
7
time
FOOD
specified
under
§§ 3-401.11 - 3-401.13
and
that is labeled frozen and shipped frozen by a
FOOD PROCESSING PLANT
shall be received frozen.
Upon receipt, POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE
(F)
8
CONTROL FOR SAFETY FOOD)
9
previous temperature abuse.
10
3-202.12
11
FOOD
12
ADDITIVES
shall be free of evidence of
Additives.*
shall
not
contain unAPPROVED
FOOD
ADDITIVES
or
that exceed amounts specified in 21 CFR 170-180 relating
13
to
FOOD ADDITIVES,
14
sanctioned substances that exceed amounts specified in 21 CFR
15
181-186, substances that exceed amounts specified in 9 CFR
16
Subpart C Section 424.21(b). Food ingredients and sources of
17
radiation, or pesticide residues that exceed
18
in 40 CFR 180 Tolerances for pesticides chemicals in food, and
19
exceptions.
20
3-202.13
Eggs.*
21
EGGS
be
22
exceed the restricted
23
as specified in United States Standards, Grades, and Weight
shall
generally recognized as safe
received
EGG
77
clean
or
prior
provisions specified
and sound and shall not
tolerances for U.S. Consumer Grade B
1
07.10.13
Classes for Shell Eggs, AMS 56.200 et seq., administered by
2
the Agricultural Marketing Service of USDA.
3
3-202.14
4
(A)
EGG
5
(B)
Fluid and dry milk and milk products shall:
Eggs and Milk Products, Pasteurized.*
shall be obtained pasteurized.
PRODUCTS
6
(1)
Be obtained pasteurized; and
7
(2)
Comply with GRADE A STANDARDS as specified in
LAW.
8
9
(C)
10
pasteurized as
11
12
Frozen milk products, such as ice cream, shall be obtained
specified
in
21 CFR 135 – Frozen
desserts.
(D)
Cheese shall be obtained pasteurized unless alternative
13
procedures to pasteurization are specified in the CFR,
14
such as 21 CFR 133 - Cheeses and related cheese products,
15
for curing certain cheese varieties.
16
3-202.15
17
FOOD packages shall be in good condition and protect the
18
integrity of the contents so that the
19
ADULTERATION
or potential contaminants.
20
3-202.16
Ice.*
21
Ice for use as a
22
DRINKING WATER.
23
3-202.17
Package Integrity.*
FOOD
FOOD
is not exposed to
or a cooling medium shall be made from
Shucked
78
Shellfish,
Packaging
and
07.10.13
1
Identification.
2
(A)
Raw
SHUCKED SHELLFISH
shall be obtained in nonreturnable
3
packages which bear a legible label that identifies the:
4
(1)
Name, address, and
5
shucker-packer
6
SHELLFISH;
7
(2)
The
or
“sell by” or
packages
with
9
(one-half
gallon)
10
packages
with
11
gallon) or more.
(B)
repacker
of
the
of the
MOLLUSCAN
and
8
12
CERTIFICATION NUMBER
A package of raw
“best if used by” date for
a capacity
or
of less than 1.89 L
the
date
shucked
for
a capacity of 1.89 L (one-half
SHUCKED SHELLFISH
that does not bear
13
a label or which bears a label which does not contain all
14
the information as specified under ¶ (A) of this section
15
shall be subject to a hold order, as allowed by
16
seizure and destruction in accordance with 21 CFR
17
Subpart D - Specific Administrative Decisions Regarding
18
Interstate Shipments, Section 1240.60(d) Molluscan shellfish.
19
3-202.18
20
(A)
LAW,
or
Shellstock Identification.*
SHELLSTOCK shall be obtained in containers bearing
21
legible
source
identification
22
affixed by the harvester or
23
or reships the
SHELLSTOCK,
79
tags or labels that are
DEALER
that depurates, ships,
as specified in the National
07.10.13
Guide for the Control of
1
Shellfish Sanitation Program
2
Molluscan Shellfish, and that list:
3
(1)
Except as specified under ¶ (C) of this section, on
4
the
harvester's
tag
or
label,
5
information in the following order:
6
(a)
the
following
The harvester's identification number that is
7
assigned
8
AUTHORITY,
by
the
SHELLFISH
CONTROL
9
(b)
The date of harvesting,
10
(c)
The most precise identification of the harvest
11
location
or
aquaculture
12
practicable based on the system of harvest
13
area
14
SHELLFISH CONTROL AUTHORITY
15
the abbreviation of the name of the state or
16
country in which the shellfish are harvested,
designations
site
that
is
that is in use by the
and including
17
(d)
The type and quantity of shellfish, and
18
(e)
The following statement in bold, capitalized type:
19
“This tag is required to be attached until
20
container is empty or retagged and thereafter
21
kept on file for 90 days;” and
22
23
(2)
Except as specified in ¶ (D) of this section, on each
DEALER's
tag or label, the following information in
80
07.10.13
1
the following order:
2
(a)
The
DEALER's
name and address, and the
3
CERTIFICATION
4
SHELLFISH CONTROL AUTHORITY,
5
(b)
NUMBER
The original shipper's
assigned
by
the
CERTIFICATION NUMBER
6
including
7
the state or country in which the shellfish
8
are harvested,
9
(c)
the abbreviation of the name of
The same information as specified for a
10
harvester's
11
(A)(1)(b)-(d) of this section, and
12
(d)
tag
under
Subparagraphs
The following statement in bold, capitalized type:
13
“This tag is required to be attached until
14
container is empty and thereafter kept on file
15
for 90 days.”
16
(B)
A container of
SHELLSTOCK that
does not bear a tag or label
17
or that bears a tag or label that does not contain all
18
the information as specified under ¶ (A) of this section
19
shall be subject to a hold order, as allowed by
LAW,
20
seizure
21 CFR
21
Subpart D - Specific Administrative Decisions Regarding
22
Interstate Shipments, Section 1240.60(d).
23
(C)
and
destruction
in
accordance with
or
If a place is provided on the harvester's tag or label for
81
07.10.13
1
a
2
the
DEALER's
If
the
3
(D)
DEALER's
name, address,
and
CERTIFICATION NUMBER,
information shall be listed first.
harvester's
each
tag
or
is
designed
to
4
accommodate
5
under Subparagraphs (A)(2)(a) and (b) of this section,
6
individual
DEALER
7
3-202.19
8
When received by a
9
reasonably free
DEALER's
label
identification as specified
tags or labels need not be provided.
Shellstock, Condition.
FOOD ESTABLISHMENT, SHELLSTOCK
of
mud, dead shellfish, and shellfish with
10
broken shells. Dead shellfish or
11
shells shall be discarded.
12
3-202.110
13
Commercially
Pre-PACKAGED
14
Processed
(A)
shall be
SHELLSTOCK
with badly broken
Juice Treated.
JUICE
shall:
Be obtained from a processor with a HACCP system as
15
specified in 21 CFR Part 120 Hazard Analysis
16
Critical Control (HACCP) Systems; and
17
(B)
and
Be obtained pasteurized or otherwise treated to attain a
18
5-log reduction of the most resistant microorganism of
19
public health significance as specified in 21 CFR Part
20
120.24 Process Controls.
21
3-203.11
Molluscan Shellfish, Original Container.
22
(A)
as
23
Except
MOLLUSCAN
specified
SHELLFISH
82
in
¶¶ (B) - (D)
of this section,
shall not be removed from
the
1
07.10.13
container in which they are received other than immediately
2
before sale or preparation for service.
3
Original
4
Containers and
the container in which they are received, displayed on
5
Records
drained ice, or held in a display
(B)
For display purposes,
SHELLSTOCK
6
quantity specified by a
7
the display
8
CONSUMER
9
(1)
The
CONSUMER
may be removed from
container, and
may be removed from
or display container and provided to the
if:
source of
SHELLSTOCK
display
11
recorded as specified under § 3-203.12; and
13
(C)
The
SHUCKED
specified
on
identified
(2)
as
the
10
12
a
SHELLSTOCK
under § 3-202.18
is
and
are protected from contamination.
may be removed from the container
SHELLFISH
14
in which they were received and held in a display
15
container from which individual servings are dispensed
16
upon a
17
(1)
CONSUMER'S
request if:
The labeling information for the shellfish on display
18
as specified under
19
correlated to the date when, or dates during which,
20
the shellfish are sold or
21
22
23
(2)
(D)
§ 3-202.17 is retained and
The shellfish are protected from contamination.
SHUCKED
SHELLFISH
may be removed from the container in
which they were received and repacked in
83
CONSUMER
self
07.10.13
1
service containers where allowed by
2
(1)
LAW
if:
The labeling information for the shellfish is
on
3
each
4
under § 3-202.17 and ¶¶ 3-602.11(A) and (B)(1) -
5
(5);
6
(2)
CONSUMER
self service container as specified
The labeling information as specified under § 3-202.17
7
is retained and correlated with the date when, or
8
dates during which, the shellfish are sold or
9
served;
10
(3)
The labeling information and dates specified under
11
Subparagraph
12
maintained for 90 days; and
13
(4)
14
3-203.12
15
(A)
(D)(2)
to the container in which the
18
until the container is empty.
21
are
Except as specified under Subparagraph (C) (2) of this
17
20
section
Shellstock, Maintaining Identification.*
section,
(B)
this
The shellfish are protected from contamination.
16
19
of
SHELLSTOCK
tags or labels shall remain attached
The date when the last
are received
SHELLSTOCK
SHELLSTOCK
from the container is
sold or served shall be recorded on the tag or label.
(C)
The identity of the source of
SHELLSTOCK
that are sold
22
or served shall be maintained by retaining
23
tags or labels for 90 calendar days from the date that is
84
SHELLSTOCK
1
07.10.13
recorded on the tag or label, as specified under ¶ B of
2
this section, by:
3
(1)
Using an
APPROVED
record keeping system that
4
keeps the tags or labels in chronological order
5
correlated to the date that is recorded on the tag
6
or label, as specified under ¶ B of this section; and
7
(2)
If
SHELLSTOCK
8
container:
9
(a)
are removed from its tagged or labeled
Preserving source identification
by using a
10
record keeping system as specified under
11
Subparagraph (C)(1) of this section, and
12
(b)
13
Ensuring that
SHELLSTOCK
from one tagged or
labeled container are not
COMMINGLED
from another container
with
14
SHELLSTOCK
15
different
16
harvest dates; or different growing areas as
17
identified on the tag or label before being
18
ordered by the
CERTIFICATION
NUMBERS;
with
different
CONSUMER.
19
20
21
3-3
PROTECTION FROM CONTAMINATION AFTER RECEIVING
Subparts
22
3-301
Preventing Contamination by Employees
23
3-302
Preventing Food and Ingredient Contamination
85
1
07.10.13
Preventing Contamination from Ice Used as a
3-303
2
Coolant
3
3-304
Preventing
4
Contamination
from
Equipment,
Utensils, and Linens
5
3-305
Preventing Contamination from the Premises
6
3-306
Preventing Contamination by Consumers
7
3-307
Preventing Contamination from Other Sources
Preventing
3-301.11
Preventing Contamination from Hands.*
10
Contamination
(A)
11
by Employees
8
9
12
FOOD
shall wash their hands as specified
EMPLOYEES
under § 2-301.12.
(B)
Except
when washing fruits and vegetables as specified
13
under § 3-302.15 or as specified in ¶ (D) of this section,
14
FOOD EMPLOYEES
15
EAT FOOD
16
UTENSILS
17
gloves, or dispensing
18
(C)
FOOD
shall not contact exposed,
with their bare hands and shall use suitable
such as deli tissue, spatulas, tongs, single-use
EMPLOYEES
contact with exposed
20
form.S
(D)
FOOD
EMPLOYEES
may
EQUIPMENT.
shall minimize bare hand and arm
19
21
READY-TO-
FOOD
READY-TO-EAT
not serving a
HIGHLY SUSCEPTIBLE
contact exposed,
READY-TO-EAT FOOD
22
POPULATION
23
with their bare hands if:
86
that is not in a
1
(1)
2
3
The
PERMIT HOLDER
obtains prior
APPROVAL
07.10.13
from the
REGULATORY AUTHORITY;
(2)
Written procedures are maintained in the
4
ESTABLISHMENT
and
made
5
REGULATORY AUTHORITY
6
(a)
available
For each bare hand contact procedure, a
listing
8
that are touched by bare hands,
(b)
to the
upon request that include:
7
9
FOOD
of the specific
READY-TO-EAT FOODS
Diagrams and other information showing that
10
handwashing
11
equipped,
12
under §§ 5-203.11, 5-204.11, 5-205.11, 6-
13
301.11, 6-301.12,
and 6-301.14,
are in an
14
easily accessible
location
in
15
proximity to the work station where the bare
16
hand contact procedure is conducted;
17
(3)
A written
facilities,
and
EMPLOYEE
installed,
maintained
as
and
located,
specified
close
health policy that details how
18
the
19
2-201.12, and 2-201.13 including:
20
(a)
FOOD ESTABLISHMENT
complies with §§ 2-201.11,
Documentation that
FOOD
EMPLOYEES
and
21
CONDITIONAL EMPLOYEES
22
are informed to report information about their
23
health
24
gastrointestinal symptoms and diseases that
87
and
activities
acknowledge that they
as
they
relate
to
1
are transmittable through
2
under ¶ 2-201.11(A),
3
(b)
Documentation that
07.10.13
as specified
FOOD
FOOD
EMPLOYEES
4
CONDITIONAL
5
responsibilities as specified under ¶ 2-201.11(E)
6
and (F), and
7
(c)
EMPLOYEES
Documentation that the
their
PERSON IN CHARGE
8
acknowledges
9
specified under ¶¶ 2-201.11(B), (C) and (D),
10
11
the
acknowledge
and
responsibilities
and §§ 2-201.12 and 2-201.13;(4)
(4)
Documentation that
FOOD EMPLOYEES
12
that they have received training in:
13
(a)
14
15
(b)
(c)
(d)
24
READY-TO-
with bare hands,
Proper handwashing as specified under § 2-
When to wash their hands as specified
Where to wash their hands as specified
under § 2-301.15,
(e)
22
23
contacting the specific
under § 2-301.14,
20
21
RISKS of
acknowledge
301.12,
18
19
The
EAT FOODS
16
17
as
Proper fingernail maintenance as specified
under § 2-302.11,
(f)
Prohibition of jewelry as specified under § 2303.11, and
88
1
07.10.13
Good hygienic practices as specified under
(g)
2
3
§§2-401.11 and 2-401.12;
(5)
Documentation that
hands
are washed before
4
FOOD
5
cross
6
specified
7
and 2-301.15 during all hours of operation when the
8
specific
9
(6)
preparation and as necessary to prevent
contamination
by
FOOD
EMPLOYEES
as
under §§ 2-301.11, 2 301.12, 2-301.14,
READY-TO-EAT FOODS
Documentation
that
are prepared;
FOOD EMPLOYEES
contacting
10
READY-TO-EAT FOOD
11
of
12
additional safeguards to
13
bare hand contact:
14
(a)
Double handwashing,
15
(b)
Nail brushes,
16
(c)
A hand antiseptic after handwashing as
17
the
following
with bare hands use two or more
control
measures
HAZARDS
specified under § 2-301.16,
89
to
provide
associated with
1
(d)
07.10.13
Incentive programs such as paid sick leave
2
that
3
not to work when they are ill, or
4
(e)
5
assist or encourage
Other control measures
REGULATORY AUTHORITY;
6
(7)
FOOD EMPLOYEES
APPROVED
by the
and
Documentation that corrective action is taken when
7
Subparagraphs (D)(1) - (6) of this section are not
8
followed.
9
3-301.12
10
A
11
taste
12
Preventing Food
13
and Ingredient
14
Contamination
15
Preventing Contamination When Tasting.*
FOOD EMPLOYEE
FOOD
3-302.11
shall not use a
UTENSIL
that is to be sold or served.
Packaged and Unpackaged Food - Separation,
Packaging, and Segregation.*
(A)
FOOD shall be protected from cross contamination by:
(1)
16
Separating
raw
animal
FOODS
during
storage,
preparation, holding, and display from:
17
(a)
Raw
READY-TO-EAT FOOD
18
animal
19
MOLLUSCAN SHELLFISH,
20
EAT FOOD
21
and
(b)
22
23
more than once to
(2)
Cooked
FOOD
such as
such
including other raw
FISH
for sushi or
or other raw
READY-TO-
as fruits and vegetables,
READY-TO-EAT FOOD;
Except when combined as ingredients, separating
90
07.10.13
from each other such
1
types of raw animal
2
as beef,
3
preparation, holding, and display by:
4
(a)
Using separate
5
(b)
Arranging each type of
FISH,
FOODS
lamb, pork, and POULTRY during storage,
EQUIPMENT
for each type, or
FOOD
in
EQUIPMENT
6
so that cross contamination of one type with
7
another is prevented, and
8
(c)
9
10
Preparing each type of
times or in separate areas;
(3)
Cleaning
EQUIPMENT
and
11
under ¶ 4-602.11(A ) and
12
under § 4-703.11;
13
at different
FOOD
(4)
Except
as
specified
as specified
UTENSILS
as specified
SANITIZING
under
Subparagraph
3
14
-501.15(B)(2) and in ¶ (B) of this section, storing
15
the
16
wrappings;
17
(5)
18
19
FOOD
Cleaning
in packages, covered containers, or
HERMETICALLY SEALED CONTAINERS
of
of visible soil before opening;
(6)
Protecting
FOOD
containers that
are received
20
packaged together
21
cuts when the case or overwrap is opened;
22
23
FOOD
(7)
in a case or overwrap from
Storing damaged, spoiled, or recalled
held in the
91
FOOD ESTABLISHMENT
FOOD
being
as specified under
07.10.13
1
§ 6-404.11; and
2
(8)
Separating
3
are
4
from
5
6
(B)
fruits
washed
and
as
vegetables,
specified
before
they
under § 3-302.15
READY-TO-EAT FOOD.
Subparagraph (A)(4) of this section does not apply to:
(1)
Whole, uncut, raw fruits and vegetables and nuts in
7
the shell, that require peeling or hulling before
8
consumption;
9
(2)
PRIMAL
CUTS,
quarters, or sides of raw
10
slab bacon that are hung on clean,
11
or placed on clean,
12
(3)
Whole,
SANITIZED
uncut, processed
MEAT
SANITIZED
or
hooks
racks;
MEATS
such as country
13
hams, and smoked or cured sausages that are
14
placed on clean,
SANITIZED
racks;
FOOD
cooled
as
15
(4)
being
16
Subparagraph 3-501.15(B)(2); or
17
(5)
18
3-302.12
specified
under
SHELLSTOCK.
Food Storage Containers, Identified with Common
19
Name of Food.
20
Except for containers holding
21
unmistakably recognized such as dry pasta, working containers
22
holding
23
original packages for use in the
FOOD
or
FOOD
92
FOOD
that can be readily and
ingredients that are removed from their
FOOD ESTABLISHMENT,
such as
1
07.10.13
cooking oils, flour, herbs, potato flakes, salt, spices, and sugar
2
shall be identified with the common name of the
3
3-302.13
FOOD.
Pasteurized Eggs, Substitute for Raw Eggs for
4
Certain Recipes.*
5
Pasteurized
6
raw
7
hollandaise
8
eggnog,
9
not:
10
(A)
11
EGGS
EGGS
or
EGG PRODUCTS
in the preparation of
ice
or
Béarnaise
cream,
and
shall
FOODS
sauce,
be
substituted
for
such as Caesar salad,
mayonnaise,
EGG-fortified
meringue,
that
BEVERAGES
are
Cooked as specified under Subparagraphs 3-401.11(A)(1)
or (2); or
12
(B)
Included in ¶ 3-401.11(D).
13
3-302.14
14
(A)
Protection from Unapproved Additives.*
FOOD shall be protected from contamination that may
15
result from the addition of, as specified in § 3-202.12:
16
(1)
17
(2)
19
21
FOOD
or
COLOR ADDITIVES;
and
18
20
Unsafe or unAPPROVED
Unsafe or unapproved levels of
APPROVED FOOD
and
COLOR ADDITIVES.
(B)
A
(1)
FOOD EMPLOYEE
may not:
Apply sulfiting agents to fresh fruits and vegetables
22
intended for
23
considered to be a good source of vitamin B1; or
93
raw consumption or
to
a
FOOD
1
(2)
Except for grapes, serve or sell
FOOD
07.10.13
specified
2
under Subparagraph (B)(1) of this section that is
3
treated with sulfiting agents before receipt by the
4
FOOD
5
3-302.15
6
(A)
ESTABLISHMENT.
Washing Fruits and Vegetables.
Except as specified in ¶ (B) of this section and except
7
for whole, raw fruits and vegetables that are intended for
8
washing by the
9
and
CONSUMER
before consumption, raw fruits
vegetables shall be thoroughly washed in water to
10
remove
11
combined with other ingredients, cooked, served, or offered
12
for human consumption in
13
(B)
14
soil and other contaminants
before
READY-TO-EAT
being cut,
form.
Fruits and vegetables may be washed by using chemicals
as specified under § 7-204.12.
15
Preventing
3-303.11
Ice Used as Exterior Coolant, Prohibited as
16
Contamination
17
from Ice Used
After use as a medium for cooling the exterior surfaces of
18
as a Coolant
such as melons or FISH, PACKAGED FOODS such as canned BEVERAGES,
Ingredient.
19
or cooling coils and tubes of
20
as
21
3-303.12
22
23
EQUIPMENT,
FOOD
ice shall not be used
FOOD.
Storage or Display of Food in Contact with
Water or Ice.
(A)
PACKAGED
FOOD
shall not be stored in direct contact with
94
07.10.13
is subject to the entry of water
1
ice or water if the
2
because of the nature of its packaging, wrapping, or
3
container or its positioning in the ice or water.
4
(B)
Except as specified in ¶¶ (C) and (D) of this section,
5
unPACKAGED
6
with undrained ice.
7
(C)
FOOD
FOOD
shall not
be stored in direct contact
Whole, raw fruits or vegetables; cut, raw vegetables such
8
as celery or carrot sticks or cut potatoes; and tofu may
9
be immersed in ice or water.
10
(D)
Raw poultry and raw
FISH
that are received immersed in
11
ice in shipping containers may remain in that condition
12
while in storage awaiting preparation, display, service, or
13
sale.
14
Preventing
3-304.11
Food Contact with Equipment and Utensils.*
15
Contamination
FOOD shall only contact surfaces of:
16
from Equipment,
(A)
17
Utensils, and
under Part 4-6 of this Code and
18
Linens
under Part 4-7 of this Code; or
EQUIPMENT and
UTENSILS
19
(B)
SINGLE-SERVICE and
20
3-304.12
21
During
22
preparation and dispensing
23
(A)
that are cleaned as specified
SANITIZED
as specified
SINGLE-USE ARTICLES.
In-Use Utensils, Between -Use Storage.
pauses
in
FOOD
preparation or dispensing,
UTENSILS
FOOD
shall be stored:
Except as specified under ¶ (B) of this section, in the
95
1
FOOD
2
the container;
3
(B)
with their handles above the top of the
07.10.13
and
FOOD
In FOOD that is not POTENTIALLY HAZARDOUS ( TIME/TEMPERATURE
4
CONTROL FOR SAFETY FOOD) with
5
of the
6
closed, such as bins of sugar, flour, or cinnamon;
7
(C)
their handles above the top
within containers or EQUIPMENT that can be
FOOD
On a clean portion of the
preparation table or
FOOD
8
cooking
9
FOOD-CONTACT surface of the FOOD preparation table or cooking
10
EQUIPMENT
11
12
EQUIPMENT
only if the in-use
are cleaned and
UTENSIL
SANITIZED
(D)
In
running
water
of
sufficient
velocity
particulates to the drain, if used with moist
14
ice cream or mashed potatoes;
(E)
In a clean, protected location if the
16
scoops,
17
POTENTIALLY HAZARDOUS
18
SAFETY FOOD);
19
at a frequency
specified under §§ 4-602.11 and 4-702.11;
13
15
and the
(F)
are
used
only
with
a
FOOD
UTENSILS,
FOOD
(TIME/TEMPERATURE
to
flush
such as
such as ice
that
is
not
CONTROL FOR
or
In a container of water if the water is maintained at a
20
temperature of at least 60oC (140oF) and the container is
21
cleaned at a frequency specified under Subparagraph 4-
22
602.11(D)(7).
96
07.10.13
1
3-304.13
Linens and Napkins, Use Limitation.
2
LINENS and napkins shall not be used in contact with
3
unless they are used to line a container for the service of
4
FOODS
5
container is refilled for a new
6
3-304.14
7
(A)
and the
LINENS
and napkins are replaced each time the
CONSUMER.
Wiping Cloths, Use Limitation.
Cloths in-use for wiping
FOOD
spills from
8
carry-out containers that occur as
9
shall be:
10
(1)
Maintained dry; and
11
(2)
Used for no other purpose.
12
(B)
surfaces shall be:
14
(1)
at
16
and
(2)
(C)
is being served
other
EQUIPMENT
Laundered daily as specified under ¶ 4-802.11(D).
Cloths in-use for wiping surfaces in contact with raw
animal
20
other purposes.
(D)
and
a concentration specified under § 4-501.114;
19
21
TABLEWARE
Held between uses in a chemical sanitizer solution
15
18
FOOD
Cloths in-use for wiping counters and
13
17
FOOD
FOODS
shall be kept separate from cloths used for
Dry wiping cloths and the chemical sanitizing solutions
22
specified in Subparagraph (B)(1) of this section in which
23
wet wiping cloths are held between uses shall be free
97
07.10.13
1
2
of
(E)
FOOD
debris and visible soil.
Containers of chemical sanitizing solutions specified in
3
Subparagraph (B)(1) of this section in which wet wiping
4
cloths are held between uses shall
5
floor and used in a manner that prevents contamination
6
of
7
SINGLE-USE ARTICLES.
8
(F)
9
FOOD, EQUIPMENT, UTENSILS, LINENS, SINGLE-SERVICE,
SINGLE-USE disposable sanitizer wipes shall be used in
instructions.
11
3-304.15
12
(A)
Gloves, Use Limitation.
If used,
SINGLE-USE
gloves shall be used
13
task such as working with
14
raw animal
15
discarded
16
interruptions occur in the operation.
(B)
FOOD,
when
used
for
no
other
damaged
or
soiled,
or with
purpose,
or
and
when
Except as specified in ¶ (C) of this section, slash-resistant
gloves
19
operations requiring cutting shall
20
contact only with
21
specified under Part 3-4 such as frozen
22
CUT
(C)
for only one
READY-TO-EAT FOOD
18
23
or
accordance with EPA-approved manufacturer’s label use
10
17
be stored off the
of
that
are used
FOOD
to
protect
the
hands
during
be used in
direct
that is subsequently cooked as
FOOD
or a PRIMAL
MEAT.
Slash-resistant gloves may be used with
98
READY-TO-EAT
07.10.13
that will not be subsequently cooked if the slash-
1
FOOD
2
resistant
3
nonabsorbent outer surface; or if the slash-resistant gloves
4
are covered with a
5
glove, or a
6
(D)
gloves
have
a
SMOOTH,
SMOOTH,
SINGLE-USE
8
under Part 3-4 such as frozen
9
MEAT.
12
nonabsorbent
Cloth gloves shall not be used in direct contact with
unless the
3-304.16
11
durable,
FOOD
is
subsequently cooked as
or a
FOOD
of
Refills.
(A)
Except
for
refilling
a
CONSUMER’S
drinking
14
and the lip-contact area
of
15
container,
FOOD EMPLOYEES
shall
16
including
SINGLE-SERVICE
17
CONSUMER,
to provide second portions or refills.
(B)
without contact between the pouring
cup
or
UTENSIL
drinking cup or
not use
TABLEWARE,
soiled
by
the
Except as specified in ¶ (C) of this section, self-service
CONSUMERS
20
including
21
from the display and serving
(C)
the
ARTICLES,
19
23
required
Using Clean Tableware for Second Portions and
container
22
FOOD
PRIMAL CUT
13
18
and
glove.
7
10
durable,
shall not be allowed to use soiled
SINGLE-SERVICE ARTICLES,
TABLEWARE,
to obtain additional
FOOD
EQUIPMENT.
Drinking cups and containers may be reused by selfservice
CONSUMERS
99
if refilling is a contamination-free
07.10.13
process as specified under ¶¶ 4-204.13(A), (B), and (D).
1
2
3-304.17
3
(A)
4
Refilling Returnables.
A take-home FOOD container returned to a FOOD ESTABLISHMENT
shall not be refilled at a
FOOD ESTABLISHMENT
5
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE
6
FOR SAFETY FOOD).
7
(B)
Except as specified in ¶ (C), a take-home
8
refilled with
9
(TIME/TEMPERATURE
10
that is not
FOOD
FOOD
with a
CONTROL
container
POTENTIALLY HAZARDOUS
CONTROL FOR SAFETY FOOD)
shall be
cleaned as specified under ¶ 4-603.17(B).
11
(C)
Personal
take-out
BEVERAGE
containers,
such
as
12
thermally insulated bottles, nonspill coffee cups, and
13
promotional
14
EMPLOYEES
15
free process as specified under ¶¶ 4-204.13(A), (B), and
16
(D).
BEVERAGE
or the
glasses,
CONSUMER
may
be refilled by
if refilling is a contamination-
17
Preventing
3-305.11
18
Contamination
(A)
19
from the
shall be protected from contamination by storing the FOOD:
20
Premises
(1)
In a clean, dry location;
(2)
Where it is not exposed to splash, dust, or other
21
Except as specified in ¶¶ (B) and (C) of this section, FOOD
22
23
Food Storage.
contamination; and
(3)
At least 15 cm (6 inches) above the floor.
100
1
(B)
2
less than 15 cm (6 inches) above the floor on case lot handling
3
4
07.10.13
FOOD in packages and working containers may be stored
EQUIPMENT
(C)
as specified under § 4-204.122.
Pressurized
BEVERAGE
containers,
cased
FOOD
in
5
waterproof containers such as bottles or cans, and
6
containers in plastic crates may be stored on a floor that
7
is clean and not exposed to floor moisture.
8
3-305.12
9
FOOD shall not be stored:
Food Storage, Prohibited Areas.
10
(A)
In locker rooms;
11
(B)
In toilet rooms;
12
(C)
In dressing rooms;
13
(D)
In garbage rooms;
14
(E)
In mechanical rooms;
15
(F)
Under
16
17
milk
sewer
lines that
are
not
shielded to
intercept potential drips;
(G)
Under leaking water lines, including leaking automatic
18
fire sprinkler heads, or under lines on which water
19
has condensed;
20
(H)
Under open stairwells; or
21
(I)
Under other sources of contamination.
22
3-305.13
23
Vended
Potentially
(Time/Temperature
101
Control
Hazardous
for
Safety
Food
Food),
07.10.13
1
Original Container
2
POTENTIALLY
3
SAFETY FOOD)
4
the
PACKAGE
5
or
FOOD PROCESSING PLANT
6
3-305.14
7
During preparation, unPACKAGED
8
environmental sources of contamination.
9
HAZARDOUS FOOD
(TIME/TEMPERATURE
dispensed through a
CONTROL FOR
VENDING MACHINE
in which it was placed at the
shall be in
FOOD ESTABLISHMENT
at which it was prepared.
Food Preparation.
FOOD
shall be protected from
Preventing
3-306.11
Food Display.
10
Contamination
Except for nuts
11
by Consumers
vegetables that are intended for hulling, peeling, or washing by
in
the shell and
12
the
13
protected from contamination by the use of
14
service line, or salad bar
15
effective means.
16
3-306.12
17
(A)
CONSUMER
before consumption,
whole, raw
FOOD
FOOD
fruits and
on display shall be
PACKAGING;
counter,
guards; display cases; or other
Condiments, Protection.
Condiments shall be protected from contamination by being
18
kept in dispensers that are designed to provide protection,
19
protected
20
original containers designed for dispensing, or individual
21
22
23
PACKAGES
(B)
FOOD
displays provided with the proper
or portions.
Condiments at a
individual
UTENSILS,
VENDING MACHINE LOCATION
PACKAGES
102
shall be in
or provided in dispensers that are
1
07.10.13
filled at an APPROVED location, such as the FOOD ESTABLISHMENT
2
that provides
FOOD
to the
3
FOOD PROCESSING PLANT
4
that has jurisdiction over
5
equipped facility that
6
VENDING MACHINE LOCATION.
7
3-306.13
8
(A)
9
the operation, or
POULTRY,
CONSUMER
11
to:
12
(1)
is located on the site of the
and
FISH
self-service.
CONSUMER
FOOD,
such as beef, lamb,
shall not
be offered for
This paragraph does not apply
self-service of
READY-TO-EAT FOODS
13
buffets or salad bars that serve
14
sushi or raw shellfish;
(2)
a properly
Consumer Self-Service Operations.*
10
15
Ready-to-cook
individual
FOODS
portions for
16
cooking and consumption on the
17
as
18
ingredients for Mongolian barbecue; or
19
20
(3)
(B)
a
that is regulated by the agency
Raw, unPACKAGED animal
pork,
VENDING MACHINE LOCATION,
CONSUMER-cooked MEATS
or
at
such as
immediate
PREMISES
such
CONSUMER-selected
Raw, frozen, shell-on shrimp, or lobster.
CONSUMER self-service operations for
21
shall be provided with suitable
22
dispensing
23
contamination.N
methods
103
that
READY-TO-EAT FOODS
UTENSILS
protect
the
or
effective
FOOD
from
1
07.10.13
CONSUMER self-service operations such as buffets and
(C)
2
salad
3
trained in safe operating procedures.N
4
3-306.14
5
(A)
bars shall
be monitored by
FOOD EMPLOYEES
Returned Food and Re-Service of Food.*
Except as specified in ¶ (B) of this section, after being
6
served or sold and in the possession of a
7
FOOD
8
not be offered as
9
(B)
that is unused or returned by the
FOOD
CONSUMER,
for human consumption.
Except as specified under ¶ 3-801.11(G), a container of
10
FOOD
11
(TIME/TEMPERATURE
12
RE-SERVED
from one
13
(1)
FOOD
that
The
is
not
CONTROL
POTENTIALLY
FOR
CONSUMER
SAFETY
HAZARDOUS
FOOD
) may be
to another if:
is dispensed so that it is protected from
14
contamination
and
the
container
15
between uses,
such
as
a
16
containing catsup, steak sauce, or wine; or
17
shall
CONSUMER
The
FOOD,
18
in
an
19
maintained in sound condition.
(2)
original
closed
narrow-neck bottle
such as crackers, salt,
unopened
is
or pepper, is
PACKAGE
and
is
20
Preventing
3-307.11
Miscellaneous Sources of Contamination.
21
Contamination
FOOD shall be protected from contamination that may result
22
from Other
from a factor or source not specified under Subparts 3-301 -
23
Sources
3-306.
104
07.10.13
1
2
3
3-4
DESTRUCTION
OF
ORGANISMS
OF
PUBLIC
HEALTH CONCERN
Subparts
4
3-401
Cooking
5
3-402
Freezing
6
3-403
Reheating
7
3-404
Other Methods
8
9
10
Cooking
3-401.11
(A)
Raw Animal Foods.*
Except as specified under ¶ (B) and in ¶¶ (C) and (D) of
11
this section, raw animal
12
MEAT, POULTRY,
13
FOODS,
and
such as
FOODS
FOODS
EGGS, FISH,
containing these raw animal
shall be cooked to heat all parts of the
FOOD
to
14
a temperature and for a time that complies with one of
15
the following methods based on the
16
cooked:
17
(1)
18
that is being
63oC (145oF) or above for 15 seconds for:
(a)
Raw
EGGS
that are broken and prepared in
19
response to a
20
immediate service, and
21
FOOD
(b)
Except
CONSUMER'S
as specified
under
order and for
Subparagraphs
22
(A)(2) and (A)(3) and ¶ (B), and in ¶ (C) of
23
this section,
105
FISH
and
MEAT
including
GAME
ANIMALS
2
specified under Subparagraph 3-201.17(A)(1)
3
and
4
inspection
5
Subparagraph 3-201.17(A)(2);
(2)
6
commercially raised for
07.10.13
as
1
GAME
ANIMALS
program
under a
as
FOOD
voluntary
specified
under
68oC (155oF) for 15 seconds or the temperature
7
specified in the following chart that corresponds to
8
the holding time for
9
the following if they are
10
RATITES
and
INJECTED MEATS;
COMMINUTED: FISH, MEAT,
GAME ANIMALS commercially raised for FOOD as specified
11
under
12
ANIMALS
13
specified
under Subparagraph 3-201.17(A)(2); and
14
raw
that are not prepared as specified under
Subparagraph 3-201.17(A)(1), and
under a voluntary inspection program as
EGGS
15
Subparagraph (A)(1)(a) of this section:
16
Minimum
17
18
Temperature
o
C (oF)
Time
19
63 (145)
3 minutes
20
66 (150)
1 minute
21
70 (158)
< 1 second (instantaneous)
22
23
24
GAME
;or
(3)
74oC (165oF)
wild
GAME
or
above for 15 seconds for
ANIMALS
106
POULTRY, BALUTS,
as specified under Subparagraphs
1
3-201.17(A)(3) and (4), stuffed
2
stuffed
3
MEAT, POULTRY,
4
(B)
Whole
MEAT
POULTRY,
or
stuffed
FISH,
RATITES,
stuffed
MEAT,
or stuffing
07.10.13
stuffed pasta,
containing
FISH,
RATITES.
roasts including beef, corned beef, lamb, pork, and cured
5
pork roasts such as ham shall be cooked:
6
(1)
In an oven that is preheated to the temperature specified for
7
the roast's weight in the following chart and that is held at that
8
temperature:
9
Oven Type
Oven Temperature Based on Roast Weight
10
Less than 4.5 kg (10 lbs)
4.5 kg (10 lbs) or More
11
Still Dry
177oC (350oF) or more
121oC (250oF) or more
12
Convection
163oC (325oF) or more
121oC (250oF) or more
13
High Humidity1
121oC (250oF) or less
121oC (250oF) or less
14
15
16
1
17
Relative humidity greater than 90% for at least 1 hour as measured in the cooking chamber or
exit of the oven; or in a moisture-impermeable bag that provides 100% humidity.
;and
(2)
As specified in the following chart, to heat all parts of the
FOOD
18
to a temperature and for the holding time that corresponds to
19
that temperature:
20
21
Temperature
°C (°F)
Time1 in
Minutes
Temperature
°C (°F)
Time1 in
Seconds
22
54.4 (130)
112
63.9(147)
134
23
55.0 (131)
89
65.0 (149)
85
24
56.1 (133)
56
66.1 (151)
54
25
57.2 (135)
36
67.2(153)
34
107
07.10.13
1
57.8 (136)
28
68.3(155)
22
2
58.9 (138)
18
69.4 (157)
14
3
60.0 (140)
12
70.0 (158)
0
4
61.1 (142)
8
5
62.2 (144)
5
6
62.8 (145)
4
7
8
9
10
1
Holding time may include postoven heat rise.
(C)
A raw or undercooked
(1)
The
FOOD ESTABLISHMENT
serves
a population that
is not a
HIGHLY SUSCEPTIBLE POPULATION,
(2)
The
steak is labeled to indicate that it meets the definition
13
“WHOLE-MUSCLE,
14
and
15
steak may be
INTACT BEEF
served or offered for sale in a READY-TO-EAT form if:
11
12
WHOLE-MUSCLE,
(3)
INTACT BEEF”
of
as specified under ¶ 3-201.11(E),
The steak is cooked on both the top and bottom to a surface
63oC (145oF) or above and a cooked
16
temperature
17
change is achieved on all external surfaces.
18
(D)
A
of
raw
animal
FOOD
such
as raw
EGG,
raw
color
FISH,
raw-
19
marinated
20
tartare; or a partially cooked
FOOD
21
cooked
or rare
22
WHOLE-MUSCLE, INTACT BEEF
23
this section, may be served or offered for sale upon
FISH,
FISH,
raw
MOLLUSCAN
soft cooked
108
EGGS,
SHELLFISH,
such
MEAT
or steak
as
lightly
other than
steaks as specified in ¶ (C) of
1
CONSUMER
2
(1)
request or selection in a
FOOD ESTABLISHMENT
4
not a
(2)
07.10.13
form if:
As specified under ¶¶ 3-801.11(C)(1) and (2), the
3
5
READY-TO-EAT
The
serves a population
HIGHLY SUSCEPTIBLE POPULATION ;
CONSUMER
that
is
and
is informed as specified under § 3-
6
603.11 that to ensure its safety, the
7
be cooked as specified under ¶ (A) or (B) of this section;
8
or
(3)
9
The
REGULATORY
AUTHORITY
FOOD
grants
a
should
VARIANCE
10
from ¶ (A) or (B) of this section as specified in § 8-
11
103.10 based on a HACCP
12
(a)
13
PLAN
that:
Is submitted by the PERMIT HOLDER and APPROVED
as specified under § 8-103.11,
14
(b)
Documents
scientific
data
or
other
15
information showing that a lesser time and
16
temperature regimen results in a safe
17
and
18
(c)
Verifies that
EQUIPMENT
19
FOOD
preparation
20
EMPLOYEES
21
the conditions of the
at the
22
3-401.12
Microwave Cooking.*
23
Raw animal
FOODS
24
(A)
and
FOOD,
and procedures for
training
of
FOOD ESTABLISHMENT
FOOD
meet
VARIANCE.
cooked in a microwave oven shall be:
Rotated or stirred throughout or midway during cooking to
109
07.10.13
1
compensate for uneven distribution of heat;
2
(B)
Covered to retain surface moisture;
3
(C)
Heated to a temperature of at least 74oC (165oF) in all
4
parts of the
5
(D)
6
FOOD;
and
Allowed to stand covered for 2 minutes after cooking to
obtain temperature equilibrium.
7
3-401.13
8
Fruits and vegetables that are cooked for hot holding shall be
9
cooked to a temperature of 60oC (140oF)
10
11
Freezing
3-402.11
(A)
Plant Food Cooking for Hot Holding.
Parasite Destruction.*
Except
as
specified in ¶ (B) of this section, before
12
service or sale in
READY-TO-EAT
form, raw, raw-marinated,
13
partially cooked, or marinated-partially cooked
14
(1)
FISH
shall be:
Frozen and stored at a temperature of -20°C (-4°F)
15
or below for a minimum of 168 hours (7 days) in
16
a freezer;
17
(2)
Frozen at -35°C (-31°F) or below until solid and
18
stored at -35°C (-31°F) or below for a minimum of
19
15 hours; or
20
(3)
Frozen at -35°C (-31°F) or below until solid and
21
stored at -20°C (-4°F) or below for a minimum of
22
24 hours.
23
(B)
Paragraph (A) of this section does not apply to:
110
07.10.13
1
(1)
MOLLUSCAN
SHELLFISH;
2
(2)
Tuna of the species Thunnus alalunga, Thunnus
3
albacares (Yellowfin tuna), Thunnus atlanticus, Thunnus
4
maccoyii (Bluefin tuna, Southern), Thunnus obesus
5
(Bigeye tuna), or Thunnus thynnus (Bluefin tuna,
6
Northern); or
7
(3)
8
Aquacultured
(a)
FISH,
such as salmon, that:
If raised in open water, are raised in net-pens,
9
or
10
(b)
11
Are raised in land-based operations such as
ponds or tanks, and
12
(c)
Are fed formulated feed, such as pellets, that
13
contains no live parasites infective to the
14
aquacultured
15
3-402.12
16
(A)
FISH.
Records, Creation and Retention.
Except as specified in ¶ 3-402.11(B) and ¶ (B) of this
17
section,
if raw,
raw-marinated,
18
marinated-partially cooked
19
READY-TO-EAT
20
freezing temperature
21
subjected and shall retain the records of the
22
ESTABLISHMENT
23
service or sale of the
form, the
FISH
partially cooked,
are served or sold in
PERSON IN CHARGE
and
or
shall record the
time to which the
FISH
are
FOOD
for 90 calendar days beyond the time of
111
FISH.
1
(B)
If the
FISH
07.10.13
are frozen by a supplier, a written agreement
2
or statement from the supplier stipulating that the
3
supplied are frozen to a temperature and for a time
4
specified under § 3-402.11 may substitute for the records
5
specified under ¶ (A) of this section.
6
(C)
FISH
If raw, raw-marinated, partially cooked, or marinated-
7
partially cooked
8
form, and the
9
Subparagraph 3-402.11 (B)(3), a written agreement or
FISH
FISH
are served or sold in
are
raised
READY-TO-EAT
and fed as specified in
10
statement
11
that the
12
Subparagraph 3-402.11(B)(3) shall
13
PERSON IN CHARGE
and retained in the records of the
14
FOOD ESTABLISHMENT
for 90 calendar days beyond the time
15
from the supplier or aquaculturist stipulating
FISH
were raised and
of service or sale of the
3-403.10
17
Cooked and refrigerated
18
service in response to an individual
19
a roast
20
temperature.
Reheating
3-403.11
as
specified in
be obtained by
the
FISH.
16
21
fed
Preparation for Immediate Service.
beef
sandwich
FOOD
that is prepared for immediate
au jus,
CONSUMER
may
Reheating for Hot Holding.*
112
be
order, such as
served
at
any
1
(A)
07.10.13
Except as specified under ¶¶ (B) and (C) and in ¶ (E)
2
of this
3
(TIME/TEMPERATURE
4
cooked, cooled, and reheated for hot holding shall be
5
reheated so that
6
temperature of at least 74oC (165oF) for 15 seconds.
7
(B)
Except
section,
as
POTENTIALLY
CONTROL
all
FOR
parts of
specified
under
HAZARDOUS
SAFETY
the
¶ (C)
FOOD)
FOOD
of
FOOD
that is
reach
this
a
section,
8
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL
9
FOR SAFETY FOOD)
reheated in a microwave oven for hot
10
holding shall be reheated so that all parts of the
11
reach a temperature of at least 74oC (165oF) and the
12
FOOD
13
covered for 2 minutes after reheating.
14
(C)
FOOD
is rotated or stirred, covered, and allowed to stand
READY-TO-EAT
FOOD
taken
from
a
commercially
15
processed,
16
intact package from a
17
inspected by the
18
jurisdiction over
19
temperature of at least 60oC (140oF) for hot holding.
20
(D)
HERMETICALLY SEALED CONTAINER,
or from an
FOOD PROCESSING PLANT
FOOD REGULATORY AUTHORITY
the
plant,
shall
be
that is
that has
heated
to
a
Reheating for hot holding as specified under ¶¶ (A) - (C)
21
of this section shall be done rapidly and the time the
22
FOOD
is between 5°C (41°F) and the temperatures specified
113
07.10.13
under ¶¶ (A) - (C) of this section shall not exceed 2
1
2
hours.
3
(E)
Remaining unsliced portions of
MEAT
roasts that are
4
cooked as specified under ¶ 3-401.11(B) may be reheated
5
for hot holding using the oven parameters and minimum
6
time and
7
3-401.11(B).
8
9
10
Other Methods
3-404.11
temperature
conditions
specified
under ¶
Treating Juice.
JUICE
PACKAGED
in a
(A)
Treated under a HACCP
FOOD ESTABLISHMENT
PLAN
shall be:
as specified in ¶¶ 8-201.12(B)
11
- (E) to attain a 5-log reduction, which is equal to a
12
99.999% reduction, of the most resistant microorganism of
13
14
public health significance; or
(B)
Labeled, if not treated to yield a 5-log reduction of the
15
most
resistant
microorganism
of
public
health
16
significance:
17
(1)
As specified under § 3-602.11, and
18
(2)
As specified in 21 CFR 101.17(g) Food labeling,
19
warning, notice, and safe handling statements, Juices
20
that have not
21
prevent,
22
pathogens with
23
product has not been pasteurized and, therefore,
been specifically
processed to
reduce, or eliminate the presence of
114
the following,
“WARNING:
This
contain
harmful
may
2
serious
3
persons with weakened immune systems.”
illness in
bacteria
children,
that
07.10.13
can cause
1
the elderly, and
4
5
6
3-5
LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH CONCERN
Subparts
7
3-501
Temperature and Time Control
8
3-502
Specialized Processing Methods
Frozen Food.
9
10
Temperature
3-501.11
11
and Time
Stored frozen
12
Control
13
3-501.12
Potentially Hazardous Food Time/Temperature
14
Control for Safety Food), Slacking.
15
Frozen
16
FOR SAFETY FOOD)
17
shall be held:
18
(A)
19
20
21
shall be maintained frozen.
FOODS
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL
that is slacked to moderate the temperature
Under refrigeration that maintains the FOOD temperature
at 5°C (41°F) or less; or
(B)
At any temperature if the
3-501.13
22
Except
23
HAZARDOUS
FOOD
remains frozen.
Thawing.
as specified
in
¶ (D) of
this
section,
POTENTIALLY
FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD)
115
07.10.13
1
shall be thawed:
2
(A)
3
4
Under refrigeration that maintains the
FOOD
temperature
at 5°C (41°F) or less; or
(B)
Completely submerged under running water:
5
(1)
At a water temperature of 21°C (70°F) or below,
6
(2)
With sufficient water velocity to agitate and float
7
off loose particles in an overflow, and
8
(3)
9
For a period of time that does not allow thawed portions
of READY-TO-EAT FOOD to rise above 5°C (41°F), or
10
(4)
For a period of time that does not allow thawed portions
11
of
a
raw
animal
12
specified under ¶ 3 401.11(A) or (B) to be above
13
5°C (41°F) for more than 4 hours including:
14
(a)
The time the
FOOD
FOOD
requiring
cooking
as
is exposed to the running
15
water and the time needed for preparation for
16
cooking, or
17
(b)
The time it takes under refrigeration to lower
the
18
19
(C)
temperature to 5°C (41°F);
As part of a cooking process if the
20
is:
21
(1)
22
FOOD
FOOD
that is frozen
Cooked as specified under ¶ 3-401.11(A) or (B) or
§ 3-401.12, or
116
1
(2)
07.10.13
Thawed in a microwave oven and immediately
2
transferred
3
with no interruption in the process; or
4
(D)
to conventional
Using any procedure if a portion of frozen
5
FOOD
6
response to an individual
7
3-501.14
8
(A)
9
cooking
EQUIPMENT,
READY-TO-EAT
is thawed and prepared for immediate service in
CONSUMER'S
order.
Cooling.*
Cooked
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE
CONTROL FOR SAFETY FOOD)
shall be cooled:
10
(1)
Within 2 hours from 57°C (135°F) to 21°C (70°F); and
11
(2)
Within a total of 6 hours from 57°C (135°F) to
12
13
5°C (41°F) or less.
(B)
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL
14
FOR SAFETY FOOD)
15
(41°F) or less if prepared
16
temperature, such as reconstituted
17
tuna.
18
(C)
Except
as
shall be cooled within 4 hours to 5°C
specified
from
ingredients at ambient
FOODS
and canned
under ¶ (D) of this section,
a
19
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL
20
FOR
21
allowing a temperature above 5°C (41°F) during shipment
22
from the supplier as specified in ¶ 3 202.11(B), shall be
23
cooled within 4 hours to 5°C (41°F) or less.
SAFETY
FOOD)
117
received
in compliance with
LAWS
1
(D)
Raw
EGGS
07.10.13
shall be received as specified under ¶ 3-
2
202.11(C) and immediately placed in refrigerated EQUIPMENT
3
that maintains an ambient air temperature of 7oC (45oF) or
4
less.
5
3-501.15
6
(A)
Cooling Methods.
Cooling shall be accomplished in accordance with
the
7
time and temperature criteria specified under § 3-501.14
8
by using one or more of the following methods based
9
on the type of
FOOD
being cooled:
10
(1)
Placing the
FOOD
in shallow pans;
11
(2)
Separating
the
FOOD
12
into
smaller
or
portions;
13
(3)
Using rapid cooling
14
(4)
Stirring the
15
FOOD
EQUIPMENT;
in a container placed in an ice
water bath;
16
(5)
Using containers that facilitate heat transfer;
17
(6)
Adding ice as an ingredient; or
18
(7)
Other effective methods.
19
(B)
When placed in cooling or cold holding
20
containers in which
21
(1)
22
23
thinner
FOOD
Arranged in the
EQUIPMENT, FOOD
is being cooled shall be:
EQUIPMENT
to provide maximum
heat transfer through the container walls; and
(2)
Loosely covered, or uncovered if protected from
118
overhead
2
Subparagraph 3-305.11(A)(2), during the cooling
3
period to facilitate heat transfer from the surface
4
of the
5
3-501.16
6
7
contamination
as
07.10.13
under
1
specified
FOOD.
Potentially Hazardous
Food (Time/Temperature
Control for Safety Food), Hot and Cold Holding.*
(A)
Except during preparation, cooking, or cooling, or when time
8
is used as the public health control as specified under §3
9
501.19, and except as specified under ¶ (B) and in ¶ (C )
10
of
this
section,
POTENTIALLY
HAZARDOUS
11
(TIME/TEMPERATURE CONTROL FOR SAFETY FOOD)
12
maintained:
13
(1)
FOOD
shall be
At 60°C (140°F) or above, except that roasts cooked
14
to a temperature and for a time specified in ¶ 3
15
401.11(B) or reheated as specified in ¶ 3-403.11(E)
16
may be held at a temperature of 54°C (130°F) or
17
above; or
18
19
(B)
(2)
At 5°C (41°F) or less.
EGGS
that have not been treated to destroy all viable
20
SALMONELLAE
21
that maintains an ambient air temperature of 7°C (45°F)
22
or less.
23
(C)
shall be stored in refrigerated
EQUIPMENT
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL
119
07.10.13
in a homogenous liquid form may be
1
FOR SAFETY FOOD)
2
maintained
3
requirements, as specified under ¶ (A) of this section,
4
while contained within specially designed
5
complies with the design and construction requirements
6
as specified under ¶ 4-204.13(E).
7
3-501.17
outside
Ready-to-Eat,
of
(Time/Temperature
9
Date Marking.*
on-premises
11
preparation
12
 prepare and
13
(A)
Except when
temperature
Potentially
8
10
the
EQUIPMENT
Hazardous
Control
PACKAGING FOOD
for
using a
Safety
that
Food
Food),
REDUCED OXYGEN
method as specified under § 3-502.12, and
PACKAGING
except as specified in ¶¶ (D) and (E) of
hold cold
control
refrigerated,
READY-TO-EAT,
POTENTIALLY
this section,
HAZARDOUS FOOD
14
(TIME/TEMPERATURE CONTROL FOR SAFETY FOOD)
15
and held in a
16
shall be clearly marked to indicate the date or day by
17
which the
18
or discarded when held at a temperature of 5°C (41°F)
19
or less for a maximum of 7 days.
20
commercially
21
(B)
FOOD ESTABLISHMENT
FOOD
specified
Processed food
refrigerated,
READY-TO-EAT,
22
 open and
(TIME/TEMPERATURE
23
hold cold
PACKAGED
by a
for more than 24 hours
shall be consumed on the
Except as
in ¶¶ (D) - (F) of
PREMISES,
this
sold,
section,
POTENTIALLY HAZARDOUS FOOD
CONTROL FOR SAFETY FOOD) prepared and
FOOD PROCESSING
120
prepared
PLANT
shall be clearly
07.10.13
marked, at the time the original container is opened in a
1
2
FOOD ESTABLISHMENT
and if the
FOOD
is held for more
3
than 24 hours, to indicate the date or day by which
4
the
5
discarded, based on the temperature and time combinations
6
specified in (A) of this section and:
7
(1)
FOOD
8
shall be consumed on the
(2)
sold, or
The day the original container is opened in the
FOOD ESTABLISHMENT
9
PREMISES,
The
day
or
shall be counted as Day 1; and
date
marked
by
the
10
ESTABLISHMENT
11
use-by date if the manufacturer determined
12
use-by date based on
13
(C)
A refrigerated,
may not exceed a manufacturer’s
FOOD
(TIME/TEMPERATURE
15
or a portion of a refrigerated,
16
HAZARDOUS FOOD
17
FOOD)
18
ingredients or portions of
19
marking
20
ingredient.
(D)
the
safety.
READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD
14
21
FOOD
CONTROL FOR SAFETY FOOD)
ingredient
READY-TO-EAT, POTENTIALLY
(TIME/TEMPERATURE
CONTROL FOR SAFETY
that is subsequently combined with additional
of
FOOD
shall retain the date
the earliest-prepared
or
first-prepared
A date marking system that meets the criteria stated in ¶¶
22
(A) and (B) of this section may include:
23
(1)
Using a method
121
APPROVED
by the
REGULATORY
07.10.13
1
AUTHORITY
2
HAZARDOUS FOOD
3
SAFETY FOOD)
4
lunchmeat or a roast, or for which date marking
5
is impractical, such as soft serve mix or milk in a
6
dispensing machine;
7
(2)
for refrigerated,
READY-TO-EAT POTENTIALLY
(TIME/TEMPERATURE
CONTROL FOR
that is frequently rewrapped, such as
Marking the date or day of preparation, with a procedure
8
to discard the
9
day by which the
FOOD
or on before the last date or
FOOD
must be consumed on the
10
premises, sold, or discarded as specified under ¶ (A)
11
of this section;
122
1
(3)
Marking
07.10.13
the date or day the original container is
2
opened in a
3
to discard the
4
day by which the
5
premises, sold, or discarded as specified under ¶
6
(B) of this section; or
7
(4)
FOOD ESTABLISHMENT,
FOOD
with a procedure
on or before the last date or
FOOD
must be consumed on the
Using calendar dates, days of the week, color-coded
8
marks, or other effective marking methods, provided
9
that
10
11
the
marking
system
REGULATORY AUTHORITY
(E)
is
disclosed
to the
upon request.
Paragraphs (A) and (B) of this section do not apply to individual
12
meal portions served or repackaged for sale from a bulk
13
container upon a consumer’s request.
14
(F)
Paragraph (B) of this section does not apply to the
15
following
16
PROCESSING PLANT
17
(1)
FOODS
prepared and
PACKAGED
inspected by a
Deli salads, such
as
by a
FOOD
REGULATORY AUTHORITY:
ham salad, seafood salad,
18
chicken salad, egg salad, pasta salad, potato salad,
19
and macaroni salad, manufactured in accordance
20
with
21
practice in manufacturing,
22
human food;
23
24
(2)
Hard
21 CFR 110
cheeses
Current
containing
good
manufacturing
packing, or holding
not
more than 39%
moisture as defined in 21 CFR 133 Cheeses and related
123
07.10.13
cheddar, gruyere,
1
cheese products, such
2
parmesan and reggiano, and romano;
3
(3)
Semi-soft
cheeses
as
containing more than 39%
4
moisture, but not more than 50% moisture, as defined
5
in 21 CFR 133 Cheeses
6
products, such as blue, edam, gorgonzola, gouda,
7
and monterey jack;
8
(4)
9
11
Cultured dairy products as defined in 21 CFR 131
Milk and
10
and related cheese
cream, such as yogurt, sour cream, and
buttermilk;
(5)
Preserved
FISH
products, such as pickled herring
12
and dried or salted cod, and other acidified
13
products defined in 21 CFR 114 Acidified foods;
14
(6)
FISH
Shelf stable, dry fermented sausages, such as
15
pepperoni and Genoa salami that are not labeled
16
“Keep Refrigerated” as specified in 9 CFR 317 Labeling,
17
marking devices, and containers, and which retain
18
the original
19
(7)
CASING
on the product; and
Shelf stable salt-cured products such as prosciutto
20
and Parma (ham) that are not labeled “Keep
21
Refrigerated” as specified in 9 CFR 317 Labeling,
22
marking devices, and containers.
124
1
3-501.18
Ready-to-Eat,
Potentially
2
(Time/Temperature Control
3
Disposition.*
4
(A)
A
FOOD
Hazardous
for
Safety
07.10.13
Food
Food),
specified in ¶ 3-501.17(A) or (B) shall be
5
discarded if it:
6
(1)
Exceeds
either
of
the
temperature
and
time
7
combinations specified in ¶ 3-501.17(A), except time
8
that the product is frozen;
9
(2)
10
Is in a container or
PACKAGE
that does not bear
a date or day; or
11
(3)
Is appropriately
marked with a date or day that
12
exceeds a temperature and time combination as
13
specified in ¶ 3-501.17(A).
(B)
14
Refrigerated,
READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD
15
(TIME/TEMPERATURE
16
in a
17
VENDING MACHINE
18
be discarded if it exceeds a temperature and time
19
combination as specified in ¶ 3-501.17(A).
20
3-501.19
21
Deleted.
22
Specialized
3-502.11
23
Processing
A
FOOD
FOOD
CONTROL FOR SAFETY FOOD)
ESTABLISHMENT
prepared
and dispensed through a
with an automatic shutoff control shall
Time as a Public Health Control.*
Variance Requirement.*
ESTABLISHMENT
125
shall obtain a
VARIANCE
from
the
1
Methods
REGULATORY AUTHORITY
2
§ 8-103.11 before:
3
(A)
4
Smoking
as a method of
FOOD
FOOD
preservation rather
than as a method of flavor enhancement;
5
(B)
Curing
6
(C)
Using
FOOD;
vinegar:
8
(1)
9
or adding
FOOD ADDITIVES
7
As a method of
FOOD
components such
as
preservation rather than as a
method of flavor enhancement, or
(2)
10
To render a
11
HAZARDOUS
12
FOOD);
13
07.10.13
as specified in § 8-103.10 and under
(D)
FOOD
so that it is not
(TIME/TEMPERATURE
Packaging FOOD using a
POTENTIALLY
CONTROL OF SAFETY
REDUCED OXYGEN PACKAGING method
14
except as specified under § 3-502.12 where a barrier to
15
Clostridium botulinum in addition to refrigeration exists;
16
(E)
Operating a
MOLLUSCAN SHELLFISH
life-support
system
17
display tank used to store and display shellfish that are
18
offered for human consumption;
19
(F)
Custom processing animals that are for personal use
20
as
21
ESTABLISHMENT;
FOOD
and
not
126
for
sale
or service
in
a
FOOD
1
(G)
2
Preparing
by the
3
(H)
07.10.13
by another method that is determined
FOOD
REGULATORY AUTHORITY
to require a
VARIANCE;
or
Sprouting seeds or beans.
4
Clostridium
3-502.12
5
botulinum and
(A)
6
Listeria
as specified under § 3-502.11 and except as specified
7
Monocytogenes
under ¶¶ (C) and (E) and as specified in ¶ (D) of this
8
Controls
section, a
9
Reduced Oxygen Packaging, Criteria.*
Except for a
FOOD ESTABLISHMENT
FOOD ESTABLISHMENT
HAZARDOUS
that obtains a
that
VARIANCE
PACKAGES POTENTIALLY
FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY
10
FOOD)
11
ensure that there are at least two barriers in place to
12
control the growth and
13
botulinum and the growth of Listeria monocytogenes.
14
(B)
A
using a
FOOD
REDUCED OXYGEN PACKAGING
toxin
ESTABLISHMENT
15
HAZARDOUS FOOD
16
FOOD)
formation
that
method shall
of Clostridium
PACKAGES POTENTIALLY
(TIME/TEMPERATURE
CONTROL FOR SAFETY
using a REDUCED OXYGEN PACKAGING method shall have
17
a HACCP
18
under ¶ 8-201.14(D) and that:
19
(1)
Identifies the
20
(2)
Except as specified under ¶¶ (C) and (E) and as
PLAN
that contains the information specified
FOOD
to be
PACKAGED;
21
specified in ¶ (D) of this section, requires that the
22
PACKAGED FOOD
23
or less and meet at least one of the following
127
shall be maintained at 5°C (41°F)
07.10.13
1
criteria:
2
(a)
Has an
3
(b)
Has a
4
(c)
Is a
of 0.91 or less,
AW
PH
of 4.6 or less,
or
MEAT
POULTRY
product cured at
5
a
6
by
7
specified
8
food
9
radiation, and is received in an intact
10
(d)
12
PROCESSING PLANT
the USDA
Is a
using
and
substances
sources
of
or
FOOD
with a high level of competing
organisms such as raw
13
regulated
in 9 CFR 424.21, Use of
ingredients
PACKAGE,
11
14
FOOD
MEAT
or raw
POULTRY;
(3)
Describes how the
PACKAGE
shall be prominently
15
and conspicuously labeled on the principal display
16
panel in bold type on a contrasting background,
17
with instructions to:
18
(a)
19
20
Maintain the
FOOD
at 5oC (41oF) or below,
and
(b)
Discard
the
if
within 14 calendar
PACKAGING
it is not served for
FOOD
21
days of its
22
on-PREMISES
23
served or sold for off-PREMISES consumption;
128
consumption,
or
consumed if
1
(4)
07.10.13
Limits the refrigerated shelf life to no more than
2
14 calendar days from
3
except the time the product is maintained frozen,
4
or the original manufacturer’s “sell by” or “use by”
5
date, whichever occurs first;
6
(5)
PACKAGING
to consumption,
Includes operational procedures that:
7
(a)
Prohibit contacting
8
(b)
Identify
9
a
FOOD
designated
with bare hands,
work
area and the
method by which:
10
(i)
Physical
barriers
or
methods
11
separation of raw
FOODS
12
TO-EAT
minimize
13
contamination, and
14
(ii)
FOODS
Access to
and
the processing
READY-
cross
EQUIPMENT
15
is
16
personnel familiar with the potential
17
HAZARDS
(c)
18
Delineate
19
procedures
20
and
21
(6)
limited
of
to responsible trained
of the operation, and
cleaning
for
and
SANITIZATION
FOOD-CONTACT
SURFACES;
Describes the training program that ensures that
22
the individual responsible for the
23
PACKAGING
REDUCED OXYGEN
operation understands the:
129
1
(a)
07.10.13
Concepts required for a safe operation,
2
(b)
EQUIPMENT and facilities, and
3
(c)
Procedures
4
5
specified
under
(B)(5) of this section and ¶ 8-201.14(D).
Fish
(C)
Except for
6
PACKAGING,
7
using a
8
Cook-Chill or
9
Sous Vide
(D)
FISH
a
that is frozen before, during, and after
shall not
FOOD ESTABLISHMENT
REDUCED OXYGEN PACKAGING
Except as specified under ¶ (C) of this section, a
ESTABLISHMENT
may package
FOOD
11
(1)
The
FOOD ESTABLISHMENT
12
PLAN
13
under ¶ 8-201.14(D);
(2)
The
(a)
FOOD
using a cook-chill or
sous vide process without obtaining a
15
PACKAGE FISH
method.
10
14
Subparagraph
VARIANCE
if:
implements a HACCP
that contains the information as specified
FOOD
is:
Prepared and consumed on the
PREMISES,
or
16
prepared and consumed off the
17
but within the same business entity with no
18
distribution or sale of the bagged product to
19
another business entity or the
20
(b)
PREMISES
CONSUMER,
Cooked to heat all parts of the
FOOD
to a
21
temperature and for a time as specified
22
under § 3-401.11,
23
(c)
Protected from contamination after cooking as
130
07.10.13
1
2
specified under Part 3-4,
(d)
Placed in a package or bag with an oxygen
3
barrier and sealed before cooking, or placed
4
in
5
immediately
6
reaching a temperature below 57°C (135°F),
7
(e)
a
PACKAGE
after
or
bag
and
sealed
cooking,
and
before
Cooled to 5°C (41°F) in the sealed
PACKAGE
8
or bag as specified under §3-501.14, and
9
subsequently:
10
(i)
Cooled to 1°C (34°F) within 48 hours
11
of reaching 5°C (41°F) and held at
12
that temperature until
13
discarded within 30 days after the
14
date of preparation;
15
(ii)
consumed
or
Cooled to 1°C (34°F) within 48 hours
16
of reaching 5°C (41°F), removed from
17
refrigeration equipment that maintains
18
a 1°C (34°F) food temperature and
19
then held at 5°C (41°F) or less for no
20
more than 72 hours, at which time the
21
FOOD
22
discarded;
23
(iii)
131
must
be
consumed
or
Cooled to 3°C (38°F) or less within 24
1
07.10.13
hours of reaching 5°C (41°F) and held
2
there for no more than 72 hours from
3
packaging, at which time the food
4
must be consumed or discarded; or
5
(iv)
Held
frozen
with
no
shelf
life
6
restriction while frozen until consumed
7
or used.
8
(f)
Held in a refrigeration unit that is equipped
9
with an electronic system that continuously
10
monitors time and temperature and is visually
11
examined for proper operation twice daily,
12
(g)
If transported off-site to a satellite location of
13
the same business entity, equipped with
14
verifiable electronic
15
ensure that times and temperatures are
16
monitored during transportation, and
17
(h)
18
19
Labeled with the product name and the date
PACKAGED;
(3)
monitoring devices to
and
The records required to confirm that cooling and
20
cold holding refrigeration time/temperature parameters
21
are required as part of the HACCP
22
maintained and are:
23
(a)
24
Made available to the
upon request, and
132
PLAN,
are
REGULATORY AUTHORITY
07.10.13
1
(b)
2
(4)
Held for 6 months; and
Written operational procedures as specified under
3
Subparagraph (B)(5) of this section and a training
4
program as specified under Subparagraph (B)(6) of
5
this section are implemented.
6
Cheese
(E)
A FOOD ESTABLISHMENT may
PACKAGE cheese using a REDUCED
7
OXYGEN PACKAGING method without obtaining
a VARIANCE if it:
8
(1)
those that
9
Limits the cheeses
PACKAGED
to
are
commercially manufactured in a FOOD PROCESSING PLANT
10
with no ingredients added in the
11
and that meet the Standards of Identity as specified in
12
21 CFR 133.150 Hard cheeses, 21 CFR 133.169
13
Pasteurized process cheese or 21 CFR 133.187
14
Semisoft cheeses;
15
(2)
16
17
Has a HACCP
PLAN
that contains the
information
specified under ¶ 8-201.14(D);
(3)
Except as specified under Subparagraphs (B)(2),
18
(B)(3)(b), and (B)(4), complies
19
section;
20
FOOD ESTABLISHMENT
(4)
Labels the
PACKAGE
with ¶ (B) of this
on the principal display panel
21
with a
“use by” date that does not exceed 30
22
days or
23
“use by” date, whichever occurs first; and
the original manufacturer’s “sell by” or
133
1
(5)
Discards the
REDUCED OXYGEN PACKAGED
07.10.13
cheese
2
if it is not sold for off-PREMISES consumption or
3
consumed within 30 calendar days of its
PACKAGING.
4
5
6
7
3-6 FOOD IDENTITY, PRESENTATION, AND ON-PREMISES LABELING
Subparts
8
3-601
Accurate Representation
9
3-602
Labeling
10
3-603
Consumer Advisory
Standards of Identity
11
12
Accurate
3-601.11
13
Representation
PACKAGED
FOOD
shall
comply
with standard
of
identity
14
requirements and standards of identity or composition, and the
15
general requirements in 21 CFR 130 – Food Standards: General
16
and 9 CFR 319 Subpart A – General.
17
3-601.12
18
(A)
Honestly Presented.
FOOD shall be offered for human consumption in a way
that does not mislead or misinform the
19
20
(B)
FOOD or
COLOR ADDITIVES,
CONSUMER.
colored overwraps, or lights
21
shall not be used to misrepresent the true appearance,
22
color, or quality of a
23
Labeling
3-602.11
Food Labels.
134
FOOD.
1
(A)
FOOD
in a
PACKAGED
FOOD ESTABLISHMENT,
2
labeled as specified in
3
labeling, and 9 CFR 317 Labeling, marking devices, and
4
containers.
5
6
(B)
LAW,
07.10.13
shall be
including 21 CFR 101 - Food
Label information shall include:
(1)
The common
name
of
the
FOOD,
or
absent
a
7
common name, an adequately descriptive identity
8
statement;
9
(2)
If made from two or more ingredients, a list of
10
ingredients
11
by weight, including a declaration of artificial color
12
or flavor and chemical preservatives, if contained
13
in the
14
(3)
15
16
FOOD;
accurate
declaration
of
the
quantity
of
contents;
(4)
17
18
An
in descending order of predominance
The name and place of business of the manufacturer,
packer, or distributor; and
(5)
The name of the
FOOD
source for each
19
FOOD ALLERGEN
20
FOOD
21
usual name of the respective ingredient (Effective
22
January 1, 2006).
23
(6)
contained in the
MAJOR
FOOD
unless the
source is already part of the common or
Except as exempted in the Federal Food, Drug, and
135
1
07.10.13
Cosmetic Act § 403(Q)(3) - (5), nutrition labeling as
2
specified
3
9 CFR 317 Subpart B Nutrition Labeling.
4
(7)
in
21 CFR 101 - Food Labeling and
For any salmonid
FISH
5
a
6
container, including a list of ingredients, displayed
7
on the retail container or by other written means,
8
such as a counter card, that discloses the use of
9
canthaxanthin.
10
(C)
Bulk
COLOR ADDITIVE,
containing canthaxanthin as
FOOD
the labeling of the bulk
that is available for
CONSUMER
FISH
self-dispensing
11
shall be prominently labeled with the following information
12
in plain view of the
13
(1)
14
CONSUMER:
The manufacturer's or processor's label that was
provided with the
15
(2)
FOOD;
or
A card, sign, or other method of notification that
16
includes
17
Subparagraphs (B)(1), (2), and (5) of this section.
18
(D)
the
Bulk, unPACKAGED
information
FOODS
unPACKAGED
20
specification need not be labeled if:
21
(1)
22
23
that
under
such as bakery products and
19
FOODS
specified
are
portioned
to
CONSUMER
A health, nutrient content, or other claim is not
made;
(2)
There are no state or local
136
LAWS
requiring labeling;
07.10.13
1
and
2
(3)
The
is manufactured or prepared on
FOOD
3
PREMISES
4
FOOD ESTABLISHMENT
5
that
6
regulated by
7
jurisdiction.
is
8
3-602.12
9
(A)
If required by
10
(B)
FOOD
11
on
12
Consumer
13
Advisory
FOOD ESTABLISHMENT
owned
by
the
or a
the
FOOD
or at another
FOOD PROCESSING PLANT
same
and
PERSON
is
regulatory agency that has
Other Forms of Information.
3-603.11
LAW, CONSUMER
ESTABLISHMENT
warnings shall be provided.
or manufacturers' dating information
shall not be concealed or altered.
FOODS
Consumption of Animal Foods that are Raw,
Undercooked, or Not Otherwise Processed to
14
15
of the
the
Eliminate Pathogens.*
(A)
Except as specified in ¶ 3-401.11(C) and Subparagraph
16
3-401.11(D)(3)
17
FOOD
18
POULTRY,
19
or
20
pathogens,
21
ingredient
22
HOLDER
23
increased
and
such as
under ¶ 3-801.11(C), if an animal
beef,
EGGS,
FISH,
lamb, milk, pork,
or shellfish is served or sold raw, undercooked,
without
otherwise
either
in
in
another
shall
inform
RISK
being
processed
READY-TO-EAT
READY-TO-EAT FOOD,
CONSUMERS
of consuming such
137
form
to
eliminate
or
the
as
an
PERMIT
of the significantly
FOODS
by way of a
1
DISCLOSURE
REMINDER,
of
3
advisories, label statements, table tents, placards,
4
other effective written means.
(B)
6
section
using
07.10.13
as specified in ¶¶ (B) and (C)
2
5
this
and
brochures, deli
case or
menu
or
DISCLOSURE shall include:
(1)
A description of the animal-derived
FOODS,
such
7
as “oysters on the half shell (raw oysters),” “raw-
8
EGG
9
cooked to order);” or
10
(2)
Caesar salad,”
Identification
of
and
the
“hamburgers (can be
animal-derived
FOODS
by
11
asterisking them to a footnote that states that the
12
items are served raw or undercooked, or contain
13
(or may contain) raw or undercooked ingredients.
14
(C)
REMINDER shall
15
FOODS
16
(1)
17
18
requiring
asterisking
DISCLOSURE
Regarding
the
the
animal-derived
to a footnote that states:
safety
of
these
items,
written
information is available upon request;
(2)
Consuming raw or undercooked
19
seafood,
20
RISK
21
include
(3)
shellfish, or
MEATS, POULTRY,
may
EGGS
increase your
of foodborne illness; or
Consuming raw or undercooked
22
seafood,
23
RISK
shellfish, or
of foodborne
138
EGGS
illness,
MEATS, POULTRY,
may increase your
especially if you have
07.10.13
1
certain medical conditions.
2
3
3-7
4
CONTAMINATED FOOD
Subpart
5
3-701
Disposition
3-701.11
Discarding
6
7
Disposition
8
or
Reconditioning
Unsafe,
Adulterated, or Contaminated Food.*
9
(A)
A
that is unsafe,
FOOD
presented
11
discarded or reconditioned according to an
12
procedure.
(B)
14
specified
FOOD that is not from an
under
or not
10
13
as
ADULTERATED,
honestly
§ 3-101.11 shall
APPROVED
be
APPROVED
source as specified
under §§ 3-201.11 - .17 shall be discarded.
15
(C)
READY-TO-EAT
FOOD
that may have been contaminated
16
by an
17
as specified under § 2-201.12 shall be discarded.
18
(D)
FOOD
EMPLOYEE
that
who has been
is contaminated
or other
RESTRICTED
by
FOOD
or
EXCLUDED
EMPLOYEES,
19
CONSUMERS,
20
hands,
21
discharges, or other means shall be discarded.
bodily
PERSONS
discharges,
through contact with their
such
as
nasal
or
oral
22
23
3-8
SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS
139
07.10.13
1
Subpart
2
3-801
Additional Safeguards
3-801.11
Pasteurized Foods, Prohibited Re-Service, and
3
4
Additional
5
Safeguards
Prohibited Food*
6
In a
7
POPULATION:
8
(A)
9
that serves a
FOOD ESTABLISHMENT
The following criteria apply to
(1)
HIGHLY SUSCEPTIBLE
JUICE:
For the purposes of this paragraph only, children
10
who are age 9 or less and receive
11
school,
12
provides custodial care are included as
13
SUSCEPTIBLE POPULATIONS;
14
(2)
day
PrePACKAGED
care
JUICE
FOOD
in a
setting, or similar facility that
or a prePACKAGED
HIGHLY
BEVERAGE
15
containing
JUICE,
16
specified
in 21 CFR, 101.17(g) Food
17
warning, notice, and safe handling statements, Juices
18
that have not
been
19
prevent, reduce,
or eliminate
20
pathogens, or a
PACKAGED JUICE
21
containing
22
specified under ¶ 3-404.11(B) shall not be served
23
or offered for sale; and
JUICE,
140
that bears a warning label as
labeling,
specifically processed to
that bears
the
presence
or
of
BEVERAGE
a warning label as
1
(3)
UnPACKAGED
that
JUICE
is
prepared
07.10.13
on the
2
premises for service or sale in a
READY-TO-EAT
3
form shall be processed under
HACCP
4
that contains the information specified under ¶¶ 8-
5
201.14(B) - (E) and as specified in 21 CFR Part 120
6
– Hazard
Analysis
7
(HACCP)
Systems,
8
Reduction, 120.24 Process controls.
9
(B)
Pasteurized
10
for raw
11
(1)
or
EGGS
EGGS
and
Critical
EGG-fortified BEVERAGES,
in which more than one
16
EGGS
18
sale in a
19
(1)
FOODS
and
Raw
EGG
is broken and the
shall not be served or offered for
READY-TO-EAT
animal
20
marinated
21
steak tartare,
23
ice cream,
are combined;
The following
(2)
EGGnog,
Except as specified in ¶ (F) of this section, recipes
15
22
Pathogen
FOODS such as Caesar salad, hollandaise or Béarnaise
and
(C)
Point
in the preparation of:
13
17
B
PLAN
shall be substituted
EGG PRODUCTS
sauce, mayonnaise, meringue,
(2)
Control
Subpart
12
14
a
form:
such
FOODS
FISH,
raw
FISH,
141
rare
raw
MOLLUSCAN
A partially cooked animal
cooked
as
MEAT,
FOOD
soft-cooked
FISH,
SHELLFISH,
rawand
such as lightly
EGGS
that are
07.10.13
1
made from raw
2
3
(D)
4
EGGS,
(3)
Raw seed sprouts.
FOOD
EMPLOYEES
and meringue; and
shall not contact
READY-TO-EAT FOOD
as
specified under ¶¶ 3-301.11(B) and (D).
5
(E)
Reserved.
6
(F)
Subparagraph (B)(2) of this section does not apply if:
7
(1)
The raw EGGS are combined immediately before cooking
8
for one
9
as specified under Subparagraph 3-401.11(A)(1), and
10
served immediately, such as an omelet, soufflé, or
11
scrambled EGGS;
12
(2)
CONSUMER’S
The raw
EGGS
serving at a single meal, cooked
are combined as an ingredient
13
immediately before
14
thoroughly cooked to a
15
as a cake, muffin, or bread; or
16
(3)
baking and the
are
form, such
The preparation of the food is conducted under a
17
HACCP
18
(a)
Identifies the
19
(b)
Prohibits contacting
20
21
READY-TO-EAT
EGGS
PLAN
that:
FOOD
to be prepared,
READY-TO-EAT FOOD
with
bare hands,
(c)
Includes specifications and practices that ensure:
22
142
1
(i)
2
07.10.13
Salmonella Enteritidis growth is controlled
before and after cooking, and
3
(ii) Salmonella
Enteritidis
4
cooking
EGGS
5
temperature
6
Subparagraph 3-401.11(A)(2),
7
(d)
8
the
and
is
destroyed by
according
time
to the
specified
in
Contains the information specified under ¶ 8201.14(D ) including procedures that:
9
(i)
Control cross contamination of
10
FOOD
with raw
11
(ii) Delineate
procedures
13
and
(e)
and
cleaning
12
14
EGGS,
for
and
16
preparation of the
17
procedures to be used.
19
Food
(G)
20
FOOD EMPLOYEE
responsible for the
FOOD
Except as specified in paragraph (H)
FOOD
SURFACES,
Describes the training program that ensures
that the
Re-service of
SANITIZATION
FOOD-CONTACT
15
18
READY-TO-EAT
understands the
of this section,
may be re-served as specified under Subparagraph
3-306.14(B)(1) and (2).
21
Prohibited
22
Re-service of
23
Food
(H)
FOOD shall not be re-served under the following conditions.
(1)
Any
FOOD
served to patients or clients who are
under contact precautions in medical isolation or
143
1
07.10.13
quarantine, or protective environment isolation shall
2
not be re-served to others outside.
3
(2)
Packages of
4
other
5
PERSONS
FOOD
CONSUMERS
from any patients, clients, or
should
not
be
re-served to
in protective environment isolation.
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
144
07.10.13
1
2
3
INTENTIONALLY LEFT BLANK
4
5
6
7
8
145
07.10.13
1
Chapter
2
2
3
Parts
Management and Personnel
4
2-1
SUPERVISION
5
2-2
EMPLOYEE HEALTH
6
2-3
PERSONAL CLEANLINESS
7
2-4
HYGIENIC PRACTICES
8
2-1
SUPERVISION
9
Subparts
10
2-101
Responsibility
11
2-102
Knowledge
12
2-103
Duties
2-101.11
Assignment.*
13
14
Responsibility
(A)
Except as specified in ¶ (B) of this section, the PERMIT HOLDER
15
shall be the PERSON IN CHARGE or shall designate a PERSON IN
16
CHARGE and shall ensure that a PERSON IN CHARGE is present at
17
the FOOD ESTABLISHMENT during all hours of operation.
18
(B)
In a FOOD ESTABLISHMENT with two or more separately PERMITTED
19
departments that are the legal responsibility of the same PERMIT
20
HOLDER
and that are located on the same PREMISES, the PERMIT
21
HOLDER
may, during specific time periods when food is not
22
being prepared, packaged, or served, designate a single
32
PERSON IN CHARGE
2
hours of operation, and who is responsible for each separately
3
PERMITTED FOOD ESTABLISHMENT
4
Knowledge
2-102.11
who is present on the
07.10.13
during all
1
PREMISES
on the PREMISES.
Demonstration.*
5
Based on the RISKS inherent to the FOOD operation, during inspections
6
and upon request the
PERSON IN CHARGE
7
REGULATORY AUTHORITY
knowledge of foodborne disease prevention,
8
application of the HAZARD Analysis and CRITICAL CONTROL POINT
9
principles, and the requirements of this Code. The PERSON IN CHARGE
10
shall demonstrate this knowledge by:
11
(A)
12
13
Complying with this Code by having no violations of
ITEMS
(B)
shall demonstrate to the
CRITICAL
during the current inspection;
Being a certified
FOOD
protection manager who has shown
14
proficiency of required information through passing a test that
15
is part of an ACCREDITED PROGRAM; or
16
(C)
Responding correctly to the inspector's questions as they relate
17
to the specific
18
include:
19
(1)
FOOD
operation.
The areas of knowledge
Describing the relationship between the prevention of
20
foodborne disease and the personal hygiene of a FOOD
21
EMPLOYEE;
22
23
(2)
Explaining the responsibility of the PERSON IN CHARGE for
preventing the transmission of foodborne disease by a
33
07.10.13
1
FOOD EMPLOYEE who has a disease or medical condition
2
that may cause foodborne disease;
3
(3)
4
5
Describing the symptoms associated with the diseases
that are transmissible through FOOD;
(4)
Explaining the significance of the relationship between
6
maintaining the time and temperature of
7
HAZARDOUS FOOD
8
SAFETY FOOD)
9
(5)
10
11
(TIME/TEMPERATURE
POTENTIALLY
CONTROL FOR
and the prevention of foodborne illness;
Explaining the HAZARDS involved in the consumption of
raw or undercooked MEAT, POULTRY, EGGS, and FISH:
(6)
temperatures and times for
Stating the required
FOOD
12
safe
POTENTIALLY
13
(TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) including
14
15
cooking
of
MEAT, POULTRY, EGGS,
(7)
and
HAZARDOUS
FOOD
FISH;
Stating the required temperatures and times for the
16
safe refrigerated storage, hot holding, cooling, and
17
reheating
18
(TIME/TEMPERATURE CONTROL FOR SAFETY FOOD);
19
(8)
of
POTENTIALLY
HAZARDOUS
FOOD
Describing the relationship between the prevention of
20
foodborne illness and the management and control of
21
the following:
22
(a)
Cross contamination,
23
(b)
Hand contact with READY-TO-EAT FOODS,
34
07.10.13
1
(c)
Handwashing, and
2
(d)
Maintaining the
3
4
FOOD ESTABLISHMENT
in a clean
condition and in good repair;
(9)
Describing
FOODS
identified as
MAJOR FOOD ALLERGENS
5
and the symptoms that a
6
cause in a sensitive individual who has an allergic
7
reaction.
8
(10)
9
MAJOR FOOD ALLERGEN
Explaining the relationship between
safety and
FOOD
providing EQUIPMENT that is:
10
(a)
Sufficient in number and capacity, and
11
(b)
Properly
12
13
designed,
constructed,
located,
installed, operated, maintained, and cleaned;
(11)
Explaining correct procedures for cleaning and
14
SANITIZING UTENSILS
15
EQUIPMENT;
16
could
(12)
and
FOOD-CONTACT SURFACES
of
Identifying the source of water used and measures
17
taken to ensure that it remains protected from
18
contamination such as providing protection from
19
backflow and precluding the creation of cross
20
connections;
21
(13)
Identifying
POISONOUS OR TOXIC MATERIALS
in the
FOOD
22
ESTABLISHMENT and the procedures necessary to ensure
23
that they are safely stored, dispensed, used, and
35
07.10.13
1
2
disposed of according to LAW;
(14)
Identifying
CRITICAL CONTROL POINTS
in the operation
3
from purchasing through sale or service that when not
4
controlled may contribute to the transmission of
5
foodborne illness and explaining steps taken to ensure
6
that the points are controlled in accordance with the
7
requirements of this Code;
8
(15)
9
Explaining the details of how the PERSON IN CHARGE and
FOOD EMPLOYEES comply with the HACCP PLAN
10
is required by the
11
between the
12
ESTABLISHMENT;
13
(16)
LAW,
this Code, or an agreement
REGULATORY AUTHORITY
assigned by this Code to the:
15
(a)
FOOD EMPLOYEE,
16
(b)
CONDITIONAL EMPLOYEE,
17
(c)
PERSON IN CHARGE,
18
(d)
REGULATORY AUTHORITY; and
(17)
and the
FOOD
Explaining the responsibilities, rights, and authorities
14
19
if a plan
Explaining how the PERSON IN CHARGE, FOOD EMPLOYEES,
20
and
21
responsibilities and EXCLUSION or RESTRICTION of FOOD
22
EMPLOYEES.
23
2-102.20
CONDITIONAL EMPLOYEES
comply with reporting
Food Protection Manager Certification.
36
07.10.13
who demonstrates knowledge by being a FOOD
1
A
2
protection manager that is certified by a
3
certification program that is evaluated and listed by a Conference for
4
Food Protection-recognized accrediting agency as conforming to the
5
Conference for Food Protection Standards for Accreditation of Food
6
Protection Manager Certification Programs is deemed to comply with
7
¶ 2-102.11(B), or a similar program approved by the
8
AUTHORITY.
9
Duties
PERSON IN CHARGE
2-103.11
FOOD
protection manager
REGULATORY
Person in Charge.
10
The PERSON IN CHARGE shall ensure that:
11
(A)
FOOD ESTABLISHMENT operations are not conducted in a private
12
home or in a room used as living or sleeping quarters as
13
specified under §6-202.111;
14
PERSONS unnecessary to the
FOOD ESTABLISHMENT
15
are not allowed in the
preparation,
16
WAREWASHING
17
authorized by the
18
ensure that exposed
19
LINENS;
and unwrapped
20
ARTICLES
are protected from contamination;
21
(B)
(C)
FOOD
maintenance
23
FOOD
storage, or
areas, except that brief visits and tours may be
PERSON IN CHARGE
FOOD;
EMPLOYEES and other
22
FOOD
operation
PERSONS
preparation,
37
clean
if steps are taken to
EQUIPMENT, UTENSILS,
SINGLE-SERVICE
PERSONS
and
and
SINGLE-USE
such as delivery and
and pesticide applicators entering the
FOOD
storage, and
WAREWASHING
areas
07.10.13
1
2
comply with this Code;
(D)
3
4
EMPLOYEES are effectively cleaning their hands, by routinely
monitoring the EMPLOYEES' handwashing;
(E)
EMPLOYEES are visibly observing FOODS as they are received to
5
determine that they are from
6
the required temperatures, protected from contamination,
7
unADULTERATED, and accurately presented, by routinely
8
monitoring the
9
evaluating FOODS upon their receipt;
10
(F)
APPROVED
EMPLOYEES'
sources, delivered at
observations and periodically
EMPLOYEES are properly cooking POTENTIALLY HAZARDOUS FOOD
11
(TIME/TEMPERATURE
12
particularly careful in cooking those
13
severe foodborne illness and death, such as
14
COMMINUTED MEATS,
15
routine monitoring of the cooking temperatures using
16
appropriate temperature measuring devices properly scaled
17
and calibrated as specified under §4-203.11 and ¶ 4-502.11(B);
18
(G)
CONTROL
FOR
SAFETY
FOODS
FOOD),
being
known to cause
EGGS
and
through daily oversight of the EMPLOYEES'
EMPLOYEES are using proper methods to rapidly cool
19
POTENTIALLY HAZARDOUS FOODS (TIME/TEMPERATURE CONTROL
20
FOR SAFETY FOODS)
21
consumption within 4 hours, through daily oversight of the
22
EMPLOYEES'
23
cooling;
that are not held hot or are not for
routine monitoring of
38
FOOD
temperatures during
07.10.13
1
(H)
CONSUMERS who order raw or partially cooked
READY-TO-EAT
2
FOODS
3
3-603.11 that the FOOD is not cooked sufficiently to ensure its
4
safety;
5
(I)
of animal origin are informed as specified under §
EMPLOYEES
are
SANITIZING
cleaned
multiuse
6
EQUIPMENT
7
routine monitoring of solution temperature and exposure time
8
for hot water
9
temperature, and exposure time for chemical SANITIZING;
10
(J)
and
properly
before they are reused, through
UTENSILS
SANITIZING,
and chemical concentration, pH,
CONSUMERS are notified that clean
TABLEWARE
is to be used
11
when they return to self-service areas such as salad bars and
12
buffets as specified under § 3-304.16;
13
(K)
Except when
APPROVAL
is obtained from the
14
AUTHORITY
15
preventing cross-contamination of
16
bare hands by properly using suitable
17
tissue, spatulas, tongs, single-use gloves, or dispensing
18
EQUIPMENT;
19
(L)
20
21
as specified in ¶ 3-301.11(D),
REGULATORY
EMPLOYEES
are
READY-TO-EAT FOOD
with
UTENSILS
such as deli
EMPLOYEES are properly trained in FOOD safety as it relates to
their assigned duties; and
(M)
FOOD EMPLOYEES and CONDITIONAL EMPLOYEES are informed of
22
their responsibility to report in accordance with
23
PERSON IN CHARGE, information about their health and activities
39
LAW,
to the
1
07.10.13
as they relate to diseases that are transmissible through FOOD,
2
as specified under ¶ 2-201.11(A).
3
4
2-2
5
EMPLOYEE HEALTH
Subpart
6
2-201
Responsibilities of Permit Holder, Person in
7
Charge,
8
Employees.*
9
Food
Employees,
and
Conditional
Responsibilities 2-201.11
Responsibility of Permit Holder, Person Charge,
10
and Reporting
Conditional Employees.*
11
Symptoms
12
and Diagnosis
(A)
The
PERMIT HOLDER
shall require FOOD EMPLOYEES and
CONDITIONAL EMPLOYEES
to report to the
PERSON IN CHARGE
13
information about their health and activities as they relate to
14
diseases that are transmissible through
15
EMPLOYEE or CONDITIONAL EMPLOYEE shall report the information
16
in a manner that allows the PERSON IN CHARGE to reduce the
17
RISK
18
necessary additional information, such as the date of onset of
19
symptoms and an illness, or of a diagnosis without symptoms if
20
the FOOD EMPLOYEE or CONDITIONAL EMPLOYEE:
21
reportable symptoms
(1)
FOOD.
A
FOOD
of foodborne disease transmission, including providing
Has any of the following symptoms:
22
(a)
Vomiting,
23
(b)
Diarrhea,
40
07.10.13
1
(c)
Jaundice,
2
(d)
Sore throat with fever, or
3
(e)
A lesion containing pus such as a boil or infected
4
wound that is open or draining and is:
5
(i)
On the hands or wrists, unless an
6
impermeable cover such as a finger cot or
7
stall protects the lesion and a SINGLE-USE
8
glove is worn over the impermeable
9
cover,
10
(ii)
On exposed portions of the arms, unless
11
the lesion is protected by an impermeable
12
cover, or
13
(iii)
On other parts of the body, unless the
14
lesion is covered by a dry, durable, tight-
15
fitting bandage;
16
reportable
17
diagnosis
(2)
Has an illness diagnosed by a
HEALTH PRACTITIONER
due to:
18
(a)
Norovirus,
19
(b)
Hepatitis A virus,
20
(c)
Shigella spp.,
21
(d)
ENTEROHEMORRHAGIC or SHIGA TOXIN-PRODUCING
22
ESCHERICHIA COLI, or
23
24
(e)
reportable
(3)
Salmonella Typhi;
Had a previous illness, diagnosed by a
41
1
past illness
HEALTH PRACTITIONER,
07.10.13
within the past 3 months due to
2
Salmonella Typhi, without having received antibiotic
3
therapy, as determined by a HEALTH PRACTITIONER;
4
reportable
(4)
Has been exposed to, or is the suspected source
5
history of
of, a CONFIRMED DISEASE OUTBREAK, because the
6
exposure
FOOD EMPLOYEE
or CONDITIONAL EMPLOYEE consumed or
7
prepared FOOD implicated in the outbreak, or consumed
8
FOOD at
9
or ill with:
10
(a)
11
an event prepared by a PERSON who is infected
Norovirus within the past 48 hours of the last
exposure,
12
(b)
ENTEROHEMORRHAGIC or SHIGA TOXIN-PRODUCING
13
ESCHERICHIA COLI, or Shigella spp. within the past
14
3 days of the last exposure,
15
(c)
16
Salmonella Typhi within the past 14 days of the
last exposure, or
17
(d)
18
Hepatitis A virus within the past 30 days of the
last exposure; or
19
reportable
5)
Has been exposed by attending or working in a
20
history of
setting where there is a CONFIRMED DISEASE
21
exposure
OUTBREAK,
or living in the same household as, and has
22
knowledge about, an individual who works or attends a
23
setting where there is a CONFIRMED DISEASE OUTBREAK,
42
1
07.10.13
or living in the same household as, and has knowledge
2
about, an individual diagnosed with an illness caused
3
by:
4
(a)
5
Norovirus within the past 48 hours of the last
exposure,
6
(b)
ENTEROHEMORRHAGIC or SHIGA TOXIN-PRODUCING
7
ESCHERICHIA COLI, or Shigella spp. within the past
8
3 days of the last exposure,
9
(c)
10
Salmonella Typhi within the past 14 days of the
last exposure, or
11
(d)
12
Hepatitis A virus within the past 30 days of the
last exposure.
13
responsibility of
(B)
The PERSON IN CHARGE shall notify the REGULATORY
14
person in charge
AUTHORITY
15
to notify the
(1)
Jaundiced, or
16
regulatory authority
(2)
Diagnosed with an illness due to a pathogen as
when a FOOD EMPLOYEE is:
17
specified under Subparagraphs (A)(2)(a) - (e) of this
18
section.
19
responsibility of
20
the person in charge
EMPLOYEE:
21
to prohibit a conditional
(1)
22
employee from becoming
a diagnosed illness as specified under
23
a food employee
Subparagraphs (A)(1) - (3) of this section, is prohibited
(C)
The PERSON IN CHARGE shall ensure that a CONDITIONAL
Who exhibits or reports a symptom, or who reports
43
1
07.10.13
from becoming a FOOD EMPLOYEE until the CONDITIONAL
2
EMPLOYEE
3
or diagnosed illness as specified under § 2-201.13; and
4
(2)
meets the criteria for the specific symptoms
Who will work as a
FOOD EMPLOYEE
5
ESTABLISHMENT
6
POPULATION
7
specified
8
prohibited from becoming a
9
CONDITIONAL EMPLOYEE
10
that serves as a
in a
FOOD
HIGHLY SUSCEPTIBLE
and reports a history of exposure as
under
Subparagraphs
(A)(4) – (5),
FOOD EMPLOYEE
is
until the
meets the criteria as specified
under ¶ 2-201.13(I).
11
responsibility of
(D)
The PERSON IN CHARGE shall ensure that a FOOD EMPLOYEE
12
the person in charge
who exhibits or reports a symptom, or who reports a
13
to exclude or restrict
diagnosed illness or a history of exposure as specified
14
under Subparagraphs (A)(1) - (5) of this section is:
15
(1)
EXCLUDED as specified under ¶¶ 2-201.12 (A) - (C), and
16
Subparagraphs (D)(1), (E)(1), (F)(1), or (G)(1) and in
17
compliance with the provisions specified under
18
¶¶ 2-201.13(A) - (G); or
19
(2)
RESTRICTED as specified under Subparagraphs 2-201.12
20
(D)(2), (E)(2), (F)(2), (G)(2), or ¶¶ 2-201.12(H) or (I) and
21
in compliance with the provisions specified under
22
¶¶ 2-201.13(D) - (I).
23
responsibility of
(E)
A FOOD EMPLOYEE or CONDITIONAL EMPLOYEE shall report to
44
1
food employees and
07.10.13
the PERSON IN CHARGE the information as specified under
2
conditional
¶ (A) of this section.
3
employees to report
4
5
responsibility of
6
food employees
7
to comply
(F)
A FOOD EMPLOYEE shall:
(1)
Comply with an EXCLUSION as specified under
¶¶ 2-201.12(A)-(C) and Subparagraphs 2-201.12(D)(1),
8
(E)(1), (F)(1), or (G)(1) and with the provisions specified
9
under ¶¶ 2-201.13(A) - (G); or
10
(2)
Comply with a
RESTRICTION
as specified under
11
Subparagraphs 2-201.12(D)(2), (E)(2), (F)(2), (G)(2), or
12
¶¶ 2-201.12 (H) or (I) and comply with the provisions
13
specified under ¶¶ 2-201.13(D) - (I).
14
conditions of
2-201.12
15
exclusion
The PERSON IN CHARGE shall EXCLUDE or RESTRICT a FOOD
16
and restriction
EMPLOYEE
17
Exclusions and Restrictions.*
from a
FOOD ESTABLISHMENT
in accordance with the
following:
18
19
Symptomatic
(A)
Except when the symptom is from a noninfectious
20
with vomiting
condition, EXCLUDE a FOOD EMPLOYEE if the
21
or diarrhea
EMPLOYEE is:
FOOD
22
(1)
Symptomatic with vomiting or diarrhea; or
23
(2)
Symptomatic with vomiting or diarrhea and diagnosed
45
1
07.10.13
with an infection from Norovirus, Shigella spp., or
2
ENTEROHEMORRHAGIC or SHIGA TOXIN-PRODUCING E. COLI.
3
jaundiced or
(B)
ExCLUDE a FOOD EMPLOYEE who is:
4
diagnosed
5
with hepatitis A
the last 7 calendar days, unless the FOOD EMPLOYEE
6
infection
provides to the
(1)
Jaundiced and the onset of jaundice occurred within
PERSON IN CHARGE
written medical
7
documentation from a
8
that the jaundice is not caused by hepatitis A virus or
9
other fecal-orally transmitted infection;
10
(2)
HEALTH PRACTITIONER
specifying
Diagnosed with an infection from hepatitis A virus within
11
14 calendar days from the onset of any illness
12
symptoms, or within 7 calendar days of the onset of
13
jaundice; or
14
(3)
15
Diagnosed with an infection from hepatitis A virus
without developing symptoms.
16
diagnosed or
17
reported previous
an infection from Salmonella Typhi, or reports a
18
infection due
previous infection with Salmonella Typhi within the past
19
to S. Typhi
3 months as specified under Subparagraph 2-201.11(A)(3).
(C)
EXCLUDE a FOOD EMPLOYEE who is diagnosed with
20
21
diagnosed with
22
an
Norovirus and is ASYMPTOMATIC:
23
asymptomatic
(1)
(D)
If a
FOOD EMPLOYEE is
diagnosed with an infection from
EXCLUDE the FOOD EMPLOYEE who works in a FOOD
46
07.10.13
1
infection from
ESTABLISHMENT
2
Norovirus
POPULATION;
3
(2)
HIGHLY SUSCEPTIBLE
or
RESTRICT the
FOOD EMPLOYEE
4
ESTABLISHMENT
5
POPULATION.
diagnosed with
7
Shigella
Shigella spp. and is ASYMPTOMATIC:
8
spp. infection
(1)
9
and
FOOD ESTABLISHMENT serving
asymptomatic
POPULATION;
11
FOOD
HIGHLY SUSCEPTIBLE
If a FOOD EMPLOYEE is diagnosed with an infection from
(2)
EXCLUDE the
FOOD EMPLOYEE
who works in a
a HIGHLY SUSCEPTIBLE
or
RESTRICT the
FOOD EMPLOYEE
12
ESTABLISHMENT
13
POPULATION.
(F)
who works in a
not serving a
6
10
(E)
serving a
who works in a
not serving a
FOOD
HIGHLY SUSCEPTIBLE
14
diagnosed with
If a FOOD EMPLOYEE is diagnosed with an infection from
15
EHEC
ENTEROHEMORRHAGIC or SHIGA TOXIN-PRODUCING E. COLI, and
16
or STEC and
is
17
asymptomatic
(1)
ASYMPTOMATIC:
EXCLUDE the
FOOD EMPLOYEE
18
ESTABLISHMENT
19
POPULATION;
(2)
20
RESTRICT the
FOOD EMPLOYEE
ESTABLISHMENT
22
POPULATION.
symptomatic with
(G)
a
HIGHLY
FOOD
SUSCEPTIBLE
or
21
23
serving
who works in a
who works in a
not serving a
FOOD
HIGHLY SUSCEPTIBLE
If a FOOD EMPLOYEE is ill with symptoms of acute onset of
47
07.10.13
1
sore throat with
sore throat with fever:
2
fever
(1)
EXCLUDE the
3
ESTABLISHMENT
4
POPULATION;
5
(2)
RESTRICT the
a
FOOD EMPLOYEE
ESTABLISHMENT
7
POPULATION.
If a
serving
HIGHLY
FOOD
SUSCEPTIBLE
or
6
(H)
who works in a
FOOD EMPLOYEE
who works in a
not serving a
FOOD
HIGHLY SUSCEPTIBLE
8
symptomatic with
9
uncovered
containing pus such as a boil or infected wound that is
10
infected
open or draining and not properly covered as specified
11
wound or pustular
under Subparagraph 2-201.11(A)(1)(e), RESTRICT the
12
boil
EMPLOYEE.
FOOD EMPLOYEE
is infected with a skin lesion
FOOD
13
14
exposed to
(I)
If a FOOD EMPLOYEE is exposed to a foodborne pathogen
15
foodborne
as specified under Subparagraphs 2-201.11(A)(4) or (5),
16
pathogen and
RESTRICT
17
works in food
LISHMENT serving
18
establishment
19
serving HSP
the
FOOD EMPLOYEE
who works in a FOOD ESTA-
a HIGHLY SUSCEPTIBLE POPULATION.
20
21
Managing
22
Exclusions
23
and
2-201.13
Removal, Adjustment, or Retention of Exclusions
and Restrictions.
The PERSON IN
CHARGE
shall adhere to the following conditions
48
1
Restrictions
07.10.13
when removing, adjusting, or retaining the EXCLUSION or RESTRICTION
2
of a FOOD EMPLOYEE:
3
(A)
4
Except when a FOOD EMPLOYEE is diagnosed with an infection
from hepatitis A virus or Salmonella Typhi:
5
removing exclusion
(1)
6
for food employee
specified under Subparagraph 2-201.12(A)(1) if the
7
who was symptomatic
FOOD EMPLOYEE:
8
and not diagnosed
(a)
9
Reinstate a FOOD EMPLOYEE who was EXCLUDED as
Is ASYMPTOMATIC for at least 24 hours; or
b)
Provides to the
PERSON IN CHARGE
10
medical
11
PRACTITIONER
12
noninfectious condition.
13
Norovirus diagnosis
(2)
If a
documentation
FOOD EMPLOYEE
from
a
written
HEALTH
that states the symptom is from a
was diagnosed with an infection
14
from Norovirus and
15
Subparagraph 2-201.12(A)(2):
RESTRICT the
EXCLUDED
as specified under
16
adjusting exclusion for
(a)
FOOD EMPLOYEE,
who is
17
food employee who
ASYMPTOMATIC
18
was symptomatic and
in a FOOD ESTABLISHMENT not serving a HIGHLY
19
is now asymptomatic
SUSCEPTIBLE POPULATION, until
for at least 24 hours and works
the conditions for
20
reinstatement as specified under Subparagraphs
21
(D)(1) or (2) of this section are met; or
22
retaining exclusion for
(b)
23
food employee who
who is
Retain the EXCLUSION for the FOOD EMPLOYEE,
ASYMPTOMATIC
49
for at least 24 hours
07.10.13
that
1
was asymptomatic
and works in a
2
and is now asymptomatic
serves a
3
and works in food
until the conditions for reinstatement as
4
establishment serving HSP
FOOD ESTABLISHMENT
HIGHLY SUSCEPTIBLE POPULATION,
specified under Subparagraphs (D)(1) or (2) of this
5
section are met.
6
Shigella spp.
7
Diagnosis
(3)
If a FOOD EMPLOYEE was diagnosed with an infection
from Shigella spp. and
8
EXCLUDED
as specified under
Subparagraph 2-201.12(A)(2):
adjusting exclusion for
(a)
10
food employee who
ASYMPTOMATIC
11
was symptomatic and
in a FOOD ESTABLISHMENT not serving a HIGHLY
12
is now asymptomatic
SUSCEPTIBLE POPULATION,
9
RESTRICT the
FOOD EMPLOYEE,
who is
for at least 24 hours and works
until the conditions for
13
reinstatement as specified under Subparagraphs
14
(E)(1) or (2) of this section are met; or
15
retaining exclusion for
(b)
Retain the EXCLUSION for the FOOD EMPLOYEE,
16
food employee who
who is ASYMPTOMATIC for at least 24 hours and
17
was asymptomatic and
works in a FOOD ESTABLISHMENT that serves a
18
is now asymptomatic
HIGHLY
SUSCEPTIBLE
POPULATION,
until
the
19
conditions for reinstatement as specified under
20
Subparagraphs (E)(1) or (2) , or (E)(1) and (3)(a)
21
of this section are met.
22
EHEC or STEC
23
Diagnosis
(4)
If a FOOD EMPLOYEE was diagnosed with an infection
from ENTEROHEMORRHAGIC or SHIGA
50
TOXIN- PRODUCING
1
ESCHERICHIA
2
Subparagraph 2-201.12(A)(2):
COLI
and
3
adjusting exclusion for
4
food employee who
ASYMPTOMATIC
5
was symptomatic and
works in a
6
is now asymptomatic
a
(a)
RESTRICT the
EXCLUDED
07.10.13
as specified under
FOOD EMPLOYEE,
who is
for at least 24 hours and
FOOD ESTABLISHMENT not
serving
HIGHLY SUSCEPTIBLE POPULATION,
until the
7
conditions for reinstatement as specified under
8
Subparagraphs (F)(1) or (2) of this section are
9
met; or
10
retaining exclusion
11
for food employee
who is ASYMPTOMATIC for at least 24 hours and
12
who was symptomatic
works in a FOOD ESTABLISHMENT that serves
13
and is now asymptomatic
a
14
and works in food
conditions for reinstatement as specified under
15
establishment serving HSP
(b)
Retain the EXCLUSION for the FOOD EMPLOYEE,
HIGHLY SUSCEPTIBLE POPULATION,
until the
Subparagraphs (F)(1) or (2) are met.
16
17
hepatitis A virus
(B)
Reinstate a FOOD EMPLOYEE who was EXCLUDED as specified
18
or jaundice
under ¶ 2-201.12(B) if the
19
diagnosis –
APPROVAL
20
removing
following conditions is met;
21
exclusions
(1)
22
23
PERSON IN CHARGE
obtains
from the REGULATORY AUTHORITY and one of the
The FOOD EMPLOYEE has been jaundiced for more than 7
calendar days;
(2)
The anicteric
51
FOOD EMPLOYEE
has been symptomatic
1
07.10.13
with symptoms other than jaundice for more than 14
2
calendar days; or
3
(3)
The FOOD EMPLOYEE provides to the PERSON IN CHARGE
4
written
medical
documentation
5
PRACTITIONER stating that the FOOD EMPLOYEE is free of a
6
hepatitis A virus infection.
7
S. Typhi
8
diagnosis –
(specified under ¶ 2-201.12(C) if:
9
removing
(1)
10
exclusions
(C)
Reinstate a
FOOD EMPLOYEE
(2)
a
EXCLUDED
HEALTH
as
The PERSON IN CHARGE obtains APPROVAL from the
REGULATORY AUTHORITY;
11
who was
from
and
The FOOD EMPLOYEE provides to the PERSON IN CHARGE
12
written
13
PRACTITIONER that states the FOOD EMPLOYEE is free from
14
S. Typhi infection.
Reinstate a
documentation
from
a
HEALTH
15
Norovirus
16
diagnosis –
specified under Subparagraphs 2-201.12(A)(2) or (D)(1) who
17
removing
was
18
exclusion
PERSON IN CHARGE obtains APPROVAL from
19
or restriction
AUTHORITY
and one of the following conditions is met:
(1)
EXCLUDED
20
(D)
medical
FOOD EMPLOYEE who
RESTRICTED
The
was
EXCLUDED
as
under Subparagraph 2-201.12(D)(2) if the
or
the REGULATORY
RESTRICTED FOOD EMPLOYEE
provides
21
to the PERSON IN CHARGE written medical documentation
22
from a
23
EMPLOYEE
HEALTH PRACTITIONER
stating that the
is free of a Norovirus infection;
52
FOOD
1
(2)
07.10.13
The FOOD EMPLOYEE was EXCLUDED or RESTRICTED after
2
symptoms of vomiting or diarrhea resolved, and more
3
than 48 hours have passed since the
4
became
5
(3)
ASYMPTOMATIC;
FOOD EMPLOYEE
or
The FOOD EMPLOYEE was EXCLUDED or RESTRICTED and
6
did not develop symptoms and more than 48 hours
7
have passed since the FOOD EMPLOYEE was diagnosed.
8
Shigella spp.
9
diagnosis –
under Subparagraphs 2-201.12(A)(2) or (E)(1) or who was
10
removing
RESTRICTED under Subparagraph 2-201.12(E)(2) if the PERSON
11
exclusion or
IN CHARGE
12
restriction
and one of the following conditions is met:
13
(E)
Reinstate a FOOD EMPLOYEE who was EXCLUDED as specified
(1)
obtains APPROVAL from the REGULATORY AUTHORITY
The EXCLUDED or RESTRICTED FOOD EMPLOYEE provides
14
to the PERSON IN CHARGE written medical documentation
15
from a
16
EMPLOYEE
17
test results showing 2 consecutive negative stool
18
specimen cultures that are taken:
19
(a)
20
23
stating that the
FOOD
is free of a Shigella spp. infection based on
Not earlier than 48 hours after discontinuance of
antibiotics, and
21
22
HEALTH PRACTITIONER
(b)
(2)
At least 24 hours apart;
The FOOD EMPLOYEE was EXCLUDED or RESTRICTED after
symptoms of vomiting or diarrhea resolved, and more
53
1
07.10.13
than 7 calendar days have passed since the FOOD
2
EMPLOYEE
3
(3)
became
ASYMPTOMATIC;
or
The FOOD EMPLOYEE was EXCLUDED or RESTRICTED and
4
did not develop symptoms and more than 7 calendar
5
days have passed since the
6
diagnosed.
FOOD EMPLOYEE
7
EHEC or STEC
8
diagnosis –
RESTRICTED as specified under Subparagraphs 2-201. 12(A)(2)
9
removing
or (F)(1) or who was RESTRICTED under Subparagraph 2-201.12
10
exclusion or
(F)(2) if the
11
restriction
the REGULATORY AUTHORITY and one of the following conditions
(F)
Reinstate a
12
is met:
13
(1)
The
FOOD EMPLOYEE
who was
was
PERSON IN CHARGE
EXCLUDED
or
obtains APPROVAL from
EXCLUDED or RESTRICTED FOOD EMPLOYEE
provides
14
to the PERSON IN CHARGE written medical documentation
15
from a
16
EMPLOYEE
17
ENTEROHEMORRHAGIC
18
ESCHERICHIA
19
consecutive negative stool specimen cultures that are
20
taken:
21
(a)
22
23
HEALTH PRACTITIONER
is
COLI
free
of
an
or SHIGA
infection
FOOD
from
TOXIN-PRODUCING
based on test results that show 2
Not earlier than 48 hours after discontinuance of
antibiotics; and
(b)
stating that the
At least 24 hours apart;
54
1
(2)
07.10.13
The FOOD EMPLOYEE was EXCLUDED or RESTRICTED after
2
symptoms of vomiting or diarrhea resolved and more
3
than 7 calendar days have passed since the
4
EMPLOYEE
5
(3)
became
ASYMPTOMATIC;
FOOD
or
The FOOD EMPLOYEE was EXCLUDED or
RESTRICTED and
6
did not develop symptoms and more than 7 days have
7
passed since the FOOD EMPLOYEE was diagnosed.
8
sore throat with
(G)
Reinstate a
9
fever-
RESTRICTED
as
FOOD EMPLOYEE
who was
specified under
EXCLUDED
or
Subparagraphs
10
removing
2-201.12(G)(1) or (2) if the FOOD EMPLOYEE provides to the
11
exclusion
PERSON IN CHARGE
12
or restriction
HEALTH PRACTITIONER
written medical documentation from a
stating that the
13
one of the following conditions:
14
(1)
15
FOOD EMPLOYEE
meets
Has received antibiotic therapy for Streptococcus
pyogenes infection for more than 24 hours;
16
(2)
17
Has at least one negative throat specimen culture for
Streptococcus pyogenes infection; or
18
(3)
19
Is otherwise determined by a
HEALTH PRACTITIONER
be free of a Streptococcus pyogenes infection.
20
Uncovered
(H)
Reinstate a
21
infected
specified under ¶ 2-201.12(H) if the skin, infected wound
22
wound or
cut, or pustular boil is properly covered with one of the
23
pustular
following:
FOOD EMPLOYEE
55
who was
RESTRICTED
as
to
1
boil – removing
2
restriction
(1)
07.10.13
An impermeable cover such as a finger cot or
stall and a single-use glove over the impermeable cover
3
if the infected wound or pustular boil is on the hand,
4
finger, or wrist;
5
(2)
6
wound or pustular boil is on the arm; or
7
(3)
8
9
An impermeable cover on the arm if the infected
A dry, durable, tight-fitting bandage if the infected
wound or pustular boil is on another part of the body.
exposure to
(I)
Reinstate a
FOOD EMPLOYEE
who was
RESTRICTED
as
10
foodborne
specified under ¶ 2-201.12(I) and was exposed to one of
11
pathogen
the following pathogens as specified under Subparagraph
12
and works in
2-201.11(A)(4) or (5):
13
food establishment
14
serving HSP – removing
15
restriction
16
17
18
Norovirus
(1)
Norovirus and one of the following conditions is met:
(a)
More than 48 hours have passed since the last
19
day the FOOD EMPLOYEE was potentially exposed;
20
or
21
(b)
More than 48 hours have passed since the FOOD
22
EMPLOYEE’S
23
ASYMPTOMATIC.
56
household
contact
became
1
Shigella spp., EHEC,
2
or STEC
(2)
07.10.13
Shigella spp. or ENTEROHEMORRHAGIC or SHIGA TOXINESCHERICHIA COLI and one of the following
PRODUCING
3
conditions is met:
4
(a)
More than 3 calendar days have passed since
5
the last day the
6
exposed; or
7
(b)
8
was potentially
More than 3 calendar days have passed since
the FOOD EMPLOYEE’S household contact became
9
10
FOOD EMPLOYEE
ASYMPTOMATIC.
S. Typhi
(3)
11
S. Typhi and one of the following conditions is met:
(a)
More than 14 calendar days have passed since
12
the last day the
13
exposed; or
14
(b)
FOOD EMPLOYEE
was potentially
More than 14 calendar days have passed since
15
the FOOD EMPLOYEE’S household contact became
16
ASYMPTOMATIC.
17
hepatitis A
(4)
Hepatitis A virus and one of the following conditions is
18
met:
19
(a)
The
FOOD EMPLOYEE
is immune to hepatitis A
20
virus infection because of a prior illness from
21
hepatitis A;
22
23
(b)
The
FOOD EMPLOYEE
is immune to hepatitis A
virus infection because of vaccination against
57
07.10.13
1
hepatitis A;
2
(c)
3
The
FOOD EMPLOYEE
is immune to hepatitis A
virus infection because of IgG administration;
4
(d)
More than 30 calendar days have passed since
5
the last day the
6
exposed;
7
(e)
FOOD EMPLOYEE
was potentially
More than 30 calendar days have passed since
8
the FOOD EMPLOYEE’S household contact became
9
jaundiced; or
10
(f)
The FOOD EMPLOYEE does not use an alternative
11
procedure that allows bare hand contact with
12
READY-TO-EAT FOOD
13
the
14
Subparagraphs (I)(4)(d) and (e) of this section,
15
and the
16
training about:
17
(i)
potential
until at least 30 days after
exposure,
FOOD EMPLOYEE
as
specified
in
receives additional
Hepatitis A symptoms and preventing the
18
transmission of infection,
19
(ii)
Proper handwashing procedures, and
20
(iii)
Protecting
READY-TO-EAT
FOOD
from
21
contamination introduced by bare hand
22
contact.
23
2-3
PERSONAL CLEANLINESS
58
07.10.13
1
Subparts
2
2-301
Hands and Arms
3
2-302
Fingernails
4
2-303
Jewelry
5
2-304
Outer Clothing
Clean Condition.*
6
7
Hands and
2-301.11
8
Arms
FOOD
9
EMPLOYEES shall keep their hands and exposed portions of their
arms clean.
10
2-301.12
11
(A)
Cleaning Procedure.*
Except as specified in ¶ (D) of this section,
FOOD EMPLOYEES
12
shall clean their hands and exposed portions of their arms,
13
including surrogate prosthetic devices for hands or arms for at
14
least 20 seconds, using a cleaning compound
15
HANDWASHING SINK
16
202.12 and Subpart 6-301.
17
(B)
in a
that is equipped as specified under § 5-
FOOD EMPLOYEES shall use the following cleaning procedure in
18
the order stated to clean their hands and exposed portions of
19
their arms, including surrogate prosthetic devices for hands
20
and arms.
21
(1)
Rinse under clean, running warm water;
22
(2)
Apply an amount of cleaning compound recommended
23
by the cleaning compound manufacturer;
59
1
(3)
07.10.13
Rub together vigorously for at least 10 to 15 seconds
2
while:
3
(a)
Paying particular attention to removing soil from
4
underneath the fingernails during the cleaning
5
procedure, and
6
(b)
Creating friction on the surfaces of the hands
7
and arms or surrogate prosthetic devices for
8
hands and arms, finger tips, and areas between
9
the fingers.
10
(4)
11
Thoroughly rinse under clean, running warm water;
and
12
(5)
Immediately follow the cleaning procedure with
13
thorough drying using a method as specified under
14
§ 6-301.12.
15
(C)
TO avoid recontaminating their hands or surrogate prosthetic
16
devices, FOOD EMPLOYEES may use disposable paper towels or
17
similar clean barriers when touching surfaces such as manually
18
operated faucet handles on a HANDWASHING SINK or the handle
19
of a restroom door.
20
(D)
If
APPROVED
and capable of removing the types of soils
21
encountered in the
22
handwashing facility may be used by FOOD EMPLOYEES to clean
23
their hands or surrogate prosthetic devices.
24
2-301.13.
FOOD
operations involved, an automatic
Special Handwash Procedures.*
60
07.10.13
1
Reserved.
2
2-301.14
3
FOOD EMPLOYEES shall clean their hands and exposed portions of their
4
arms as specified under §2-301.12 immediately before engaging in
5
FOOD
6
EQUIPMENT and UTENSILS, and unwrapped SINGLE-SERVICE and SINGLE-
7
USE ARTICLES
8
(A)
9
When to Wash.*
preparation including working with exposed
FOOD,
clean
and:
After touching bare human body parts other than clean hands
and clean, exposed portions of arms;
10
(B)
After using the toilet room;
11
(C)
After caring for or handling SERVICE ANIMALS or aquatic animals
12
13
as specified in ¶ 2-403.11(B);
(D)
Except as specified in ¶ 2-401.11(B), after coughing, sneezing,
14
using a handkerchief or disposable tissue, using tobacco,
15
eating, or drinking;
16
(E)
After handling soiled EQUIPMENT or UTENSILS;
17
(F)
During FOOD preparation, as often as necessary to remove soil
18
and contamination and to prevent cross contamination when
19
changing tasks;
20
(G)
21
When switching between working with raw FOOD and working
with READY-TO-EAT FOOD;
22
(H)
Before donning gloves for working with FOOD; and
23
(I)
After engaging in other activities that contaminate the hands.
61
07.10.13
1
2-301.15
2
FOOD
3
APPROVED
4
hands in a sink used for
5
service sink or a curbed cleaning facility used for the disposal of mop
6
water and similar liquid waste.
7
2-301.16
8
(A)
9
Where to Wash.
EMPLOYEES
shall clean their hands in a
HANDWASHING SINK
or
automatic handwashing facility and shall not clean their
FOOD
preparation or
WAREWASHING,
or in a
Hand Antiseptics.
A hand antiseptic used as a topical application, a hand
antiseptic solution used as a hand dip, or a hand antiseptic
10
soap shall:
11
(1)
12
Comply with one of the following:
(a)
Be an
APPROVED
drug that is listed in the FDA
13
publication Approved Drug Products with
14
Therapeutic Equivalence Evaluations as an
15
APPROVED
16
effectiveness; or
17
(b)
drug
based
on
safety
and
Have active antimicrobial ingredients that are
18
listed in the FDA monograph for OTC Health-
19
Care Antiseptic Drug Products as an antiseptic
20
handwash, and
21
22
23
(2)
Comply with one of the following:
(a)
Have components that are exempted from the
requirement of being listed in federal
62
FOOD
07.10.13
regulations as specified in 21 CFR
1
ADDITIVE
2
170.39 - Threshold of regulation for substances
3
used in food-contact articles; or
4
(b)
5
Comply with and be listed in:
(i)
21 CFR 178 - Indirect Food Additives:
6
Adjuvants,
7
Sanitizers as regulated for use as a FOOD
8
ADDITIVE
9
(ii)
Production
Aids,
and
with conditions of safe use, or
21 CFR 182 - Substances Generally
10
Recognized as Safe, 21 CFR 184 - Direct
11
Food Substances Affirmed as Generally
12
Recognized as Safe, or 21 CFR 186 -
13
Indirect Food Substances Affirmed as
14
Generally Recognized as Safe for use in
15
contact with food, and;
16
(3)
17
18
Be applied only to hands that are cleaned as specified
under § 2-301.12.
(B)
If a hand antiseptic or a hand antiseptic solution used as a
19
hand dip does not meet the criteria specified under
20
Subparagraph (A)(2) of this section, use shall be:
21
(1)
22
23
Followed by thorough hand rinsing in clean water before
hand contact with FOOD or by the use of gloves; or
(2)
Limited to situations that involve no direct contact
63
07.10.13
1
with
2
(C)
FOOD
by the bare hands.
A hand antiseptic solution used as a hand dip shall be
3
maintained clean and at a strength equivalent to at least 100
4
MG/L
5
Fingernails
chlorine.
2-302.11
6
(A)
FOOD
Maintenance.
EMPLOYEES
shall keep their fingernails trimmed, filed,
7
and maintained so the edges and surfaces are cleanable and
8
not rough.
9
(B)
Unless wearing intact gloves in good repair, a FOOD EMPLOYEE
10
shall not wear fingernail polish or artificial fingernails when
11
working with exposed FOOD.
12
Jewelry
2-303.11
Prohibition.
13
Except for a plain ring such as a wedding band, while preparing FOOD,
14
FOOD EMPLOYEES shall not wear jewelry including medical information
15
jewelry on their arms and hands.
16
Outer Clothing
2-304.11
Clean Condition.
17
FOOD
18
contamination of
19
SERVICE
20
21
2-4
EMPLOYEES
shall wear clean outer clothing to prevent
FOOD, EQUIPMENT, UTENSILS, LINENS,
and SINGLE-USE ARTICLES.
HYGIENIC PRACTICES
Subparts
64
and
SINGLE-
07.10.13
1
2-401
Food Contamination Prevention
2
2-402
Hair Restraints
3
2-403
Animals
Eating, Drinking, or Using Tobacco.*
4
5
Food
2-401.11
6
Contamination
(A)
7
Prevention
Except as specified in ¶ (B) of this section, an
EMPLOYEE
shall eat, drink, or use any form of tobacco
8
only in designated areas where the contamination of exposed
9
FOOD;
clean
EQUIPMENT, UTENSILS,
10
SINGLE-SERVICE
11
needing protection can not result.
12
(B)
and
and
LINENS;
SINGLE-USE ARTICLES;
unwrapped
or other items
A FOOD EMPLOYEE may drink from a closed BEVERAGE container
13
if the container is handled to prevent contamination of:
14
(1)
The EMPLOYEE'S hands;
15
(2)
The container; and
16
(3)
Exposed FOOD; clean EQUIPMENT, UTENSILS, and LINENS;
17
and
unwrapped
18
ARTICLES.
SINGLE-SERVICE
and
SINGLE-USE
19
2-401.12
Discharges from the Eyes, Nose, and Mouth.*
20
FOOD
21
runny nose that causes discharges from the eyes, nose, or mouth
22
shall not work withexposed
23
LINENS;
EMPLOYEES
experiencing persistent sneezing, coughing, or a
FOOD;
clean
or unwrapped SINGLE-SERVICE or
65
EQUIPMENT, UTENSILS,
SINGLE-USE ARTICLES.
and
07.10.13
1
Hair
2-402.11
2
Restraints
(A)
Effectiveness.
Except as provided in ¶ (B) of this section,
FOOD EMPLOYEES
3
shall wear hair restraints such as hats, hair coverings or nets,
4
beard restraints, and clothing that covers body hair, that are
5
designed and worn to effectively keep their hair from contacting
6
exposed
7
unwrapped SINGLE-SERVICE and SINGLE-USE ARTICLES.
8
(B)
9
FOOD;
clean
This section does not apply to
counter staff who only serve
10
PACKAGED FOODS,
11
minimal
12
EQUIPMENT, UTENSILS,
13
SERVICE
14
15
EQUIPMENT, UTENSILS,
Animals
2-403.11
(A)
RISK
and
LINENS;
FOOD EMPLOYEES
BEVERAGES
and
such as
and wrapped or
hostesses, and wait staff if they present a
of contaminating exposed
and
LINENS;
FOOD;
and unwrapped
clean
SINGLE-
and SINGLE-USE ARTICLES.
Handling Prohibition.*
Except as specified in ¶ (B) of this section,
FOOD EMPLOYEES
16
shall not care for or handle animals that may be present such
17
as patrol dogs,
18
specified in Subparagraphs 6-501.115(B)(2)-(5).
19
(B)
FOOD
SERVICE ANIMALS,
or pets that are allowed as
EMPLOYEES with SERVICE ANIMALS may handle or care for
20
their SERVICE ANIMALS and FOOD EMPLOYEES may handle or care
21
for FISH in aquariums or MOLLUSCAN SHELLFISH or crustacea in
22
display tanks if they wash their hands as specified under
23
§ 2-301.12 and ¶ 2-301.14(C).
66
07.10.13
1
Chapter
2
1
3
Parts
4
1-1
TITLE, INTENT, SCOPE
5
1-2
DEFINITIONS
1-1
TITLE, INTENT, SCOPE
Purpose and Definitions
6
7
8
Subparts
9
1-101
Title
10
1-102
Intent
11
1-103
Scope
1-101.10
Guam Food Code.
12
13
Title
14
These provisions shall be known as the Guam Food Code, hereinafter
15
referred to as “this Code.”
16
Intent
1-102.10
Food Safety, Illness Prevention, and Honest Presentation.
17
The purpose of this Code is to safeguard public health and provide to
18
CONSUMERS FOOD
19
Scope
1-103.10
that is safe, unADULTERATED, and honestly presented.
Statement.
20
This Code establishes definitions; sets standards for management and
21
personnel, FOOD operations, and EQUIPMENT and facilities; and provides for
22
FOOD ESTABLISHMENT
plan review,
1
PERMIT
issuance, inspection,
EMPLOYEE
and
RESTRICTION,
2
maintained by and publicly accessible at the Department of Public Health and
3
Social Services, shall be the official interpretation and explanation of the
4
provisions of this Code. The enforcement of the Guam Food Code by the
5
REGULATORY AUTHORITY
6
Code, and in the interim, the regulations entitled “Rules and Regulations
7
Relative to Eating and Drinking Establishments” shall continued to be
8
enforced but repealed and replaced by this Code after the lapse of the 365
9
days when the enforcement of this Code begins.
PERMIT
suspension.
07.10.13
Guam Food Code Annex 1,
1
shall commence 365 days after the adoption of this
10
11
1-2 DEFINITIONS
12
Subpart
13
14
Applicability
15
and Terms
16
Defined
17
(A)
18
19
1-201
Applicability and Terms Defined
1-201.10
Statement of Application and Listing of Terms.
The following definitions shall apply in the interpretation and application of
this Code.
(B)
20
Terms Defined.
¶ 1-201.10(B) shall have the meaning stated below.
21
Accredited Program.
22
(1)
23
As used in this Code, each of the terms listed in
“Accredited program” means a food protection manager certification
program that has been evaluated and listed by a REGULATORY AUTHORITY.
2
1
(2)
2
07.10.13
“Accredited program” does not refer to training functions or educational
programs.
3
Additive.
4
(1)
5
6
“Food additive” has the meaning stated in the Federal Food, Drug, and
Cosmetic Act, § 201(s) and 21 CFR 170.3(e)(1).
(2)
7
“Color additive” has the meaning stated in the Federal Food, Drug, and
Cosmetic Act, § 201(t) and 21 CFR 70.3(f).
8
“Adulterated” has the meaning stated in the Federal Food, Drug, and Cosmetic
9
Act, § 402.
10
“Approved” means acceptable to the
11
determination of conformity with principles, practices, and generally recognized
12
standards that protect public health.
13
Asymptomatic.
14
(1)
REGULATORY AUTHORITY
based on a
“Asymptomatic” means without obvious symptoms; not showing or
15
producing indications of a disease or other medical condition, such as an
16
individual infected with a pathogen but not exhibiting or producing any signs
17
or symptoms of vomiting, diarrhea, or jaundice.
18
19
(2)
“Asymptomatic” includes not showing symptoms because symptoms have
resolved or subsided, or because symptoms never manifested.
20
“aw” means water activity which is a measure of the free moisture in a FOOD, is the
21
quotient of the water vapor pressure of the substance divided by the vapor pressure
22
of pure water at the same temperature, and is indicated by the symbol AW.
3
1
07.10.13
“Balut” means an embryo inside a fertile EGG that has been incubated for a period
2
sufficient for the embryo to reach a specific stage of development after which it is
3
removed from incubation before hatching.
4
“Beverage” means a liquid for drinking, including water.
5
“Bottled drinking water” means water that is SEALED in bottles, packages, or other
6
containers and offered for sale for human consumption, including bottled mineral
7
water.
8
“Casing” means a tubular container for sausage products made of either
9
natural or artificial (synthetic) material.
10
“Certification number” means a unique combination of letters and numbers
11
assigned by a
12
according to the provisions of the National Shellfish Sanitation Program.
13
“CFR” means CODE OF FEDERAL REGULATIONS. Citations in this Code to the CFR
14
refer sequentially to the Title, Part, and Section numbers, such as 40 CFR 180.194
15
refers to Title 40, Part 180, Section 194.
16
CIP.
17
(1)
SHELLFISH CONTROL AUTHORITY
to a
MOLLUSCAN SHELLFISH DEALER
“CIP” means cleaned in place by the circulation or flowing by mechanical
18
means through a piping system of a detergent solution, water rinse, and
19
SANITIZING
20
such as the method used, in part, to clean and
21
machine.
solution onto or over
EQUIPMENT
4
surfaces that require cleaning,
SANITIZE
a frozen dessert
1
(2)
“CIP” does not include the cleaning of
EQUIPMENT
07.10.13
such as band saws,
2
slicers, or mixers that are subjected to in-place manual cleaning without the
3
use of a CIP system.
4
“Commingle” means:
5
(1)
6
growing areas as identified on the tag or label, or
7
(2)
8
9
10
To combine
SHUCKED SHELLFISH
from containers with different container
codes or different shucking dates.
Comminuted.
(1)
11
12
To combine SHELLSTOCK harvested on different days or from different
“Comminuted” means reduced in size by methods including chopping,
flaking, grinding, or mincing.
(2)
“Comminuted” includes FISH or MEAT products that are reduced in size and
13
restructured or reformulated such as gefilte
14
sausage; and a mixture of 2 or more types of MEAT that have been reduced in
15
size and combined, such as sausages made from 2 or more MEATS.
16
“Conditional employee” means a potential FOOD EMPLOYEE to whom a job offer is
17
made, conditional on responses to subsequent medical questions or examinations
18
designed to identify potential FOOD EMPLOYEES who may be suffering from a disease
19
that can be transmitted through
20
Americans with Disabilities Act of 1990.
21
“Confirmed disease outbreak” means a FOODBORNE DISEASE OUTBREAK in which
22
laboratory analysis of appropriate specimens identifies a causative agent or
23
epidemiological analysis implicates a FOOD as the source of the illness.
FOOD
FISH,
gyros, ground beef, and
and done in compliance with Title 1 of the
5
1
07.10.13
“Consumer” means a PERSON who is a member of the public, takes possession of
2
FOOD,
3
FOOD ESTABLISHMENT or FOOD PROCESSING PLANT,
4
is not functioning in the capacity of an operator of a
FOOD for
and does not offer the
resale.
5
“Corrosion-resistant material” means a material that maintains acceptable
6
surface cleanability characteristics under prolonged influence of the
7
contacted, the normal use of cleaning compounds and
8
other conditions of the use environment.
9
“Counter-mounted equipment” means
EQUIPMENT
SANITIZING
FOOD
to be
solutions, and
that is not portable and is
10
designed to be mounted off the floor on a table, counter, or shelf.
11
“Critical control point” means a point or procedure in a specific
12
where loss of control may result in an unacceptable health RISK.
13
Critical Item.
14
(1)
FOOD
system
“Critical item” means a provision of this Code, that, if in noncompliance, is
15
more likely than other violations to contribute to FOOD contamination, illness,
16
or environmental health HAZARD.
17
(2)
“Critical item” is an item that is denoted in this Code with an asterisk *.
18
“Critical limit” means the maximum or minimum value to which a physical,
19
biological, or chemical parameter must be controlled at a CRITICAL CONTROL POINT to
20
minimize the RISK that the identified FOOD safety HAZARD may occur.
21
“Dealer” means a PERSON who is authorized by a SHELLFISH CONTROL AUTHORITY for
22
the activities of
SHELLSTOCK
shipper, shucker-packer, repacker, reshipper, or
6
07.10.13
according to the provisions of the
1
depuration processor of
2
National Shellfish Sanitation Program.
3
“Disclosure” means a written statement that clearly identifies the animal-derived
4
FOODS
5
processed to eliminate pathogens, or items that contain an ingredient that is raw,
6
undercooked, or without otherwise being processed to eliminate pathogens.
7
Drinking Water.
8
(1)
9
MOLLUSCAN SHELLFISH
which are, or can be ordered, raw, undercooked, or without otherwise being
“Drinking water” means water that meets criteria as specified in 40CFR 141
National Primary Drinking Water Regulations.
10
(2)
“Drinking water” is traditionally known as “potable water.”
11
(3)
“Drinking water” includes the term “water” except where the term used
12
connotes that the water is not potable, such as “boiler water,” “mop water,”
13
“rainwater,” “wastewater,” and “nondrinking” water.
14
“Dry storage area” means a room or area designated for the storage of PACKAGED
15
or containerized bulk FOOD that is not POTENTIALLY HAZARDOUS (TIME/TEMPERATURE
16
CONTROL FOR SAFETY FOOD)
17
Easily Cleanable.
18
(1)
and dry goods such as SINGLE-SERVICE items.
“Easily cleanable” means a characteristic of a surface that:
19
(a)
Allows effective removal of soil by normal cleaning methods;
20
(b)
Is dependent on the material, design, construction, and installation of
21
22
23
the surface; and
(c)
Varies with the likelihood of the surface's role in introducing
pathogenic or toxigenic agents or other contaminants into FOOD based
7
07.10.13
on the surface's APPROVED placement, purpose, and use.
1
2
(2)
“Easily cleanable” includes a tiered application of the criteria that qualify the
3
surface as
4
definition to different situations in which varying degrees of cleanability are
5
required such as:
6
(a)
EASILY CLEANABLE
as specified in Subparagraph (1) of this
The appropriateness of stainless steel for a FOOD preparation surface
7
as opposed to the lack of need for stainless steel to be used for floors
8
or for tables used for CONSUMER dining; or
9
(b)
The need for a different degree of cleanability for a utilitarian
10
attachment or accessory in the kitchen as opposed to a decorative
11
attachment or accessory in the CONSUMER dining area.
12
“Easily movable” means:
13
(1)
mechanical means to safely tilt a unit of EQUIPMENT for cleaning; and
14
15
Portable; mounted on casters, gliders, or rollers; or provided with a
(2)
Having no utility connection, a utility connection that disconnects quickly, or a
16
flexible utility connection line of sufficient length to allow the EQUIPMENT to be
17
moved for cleaning of the EQUIPMENT and adjacent area.
18
Egg.
19
(1)
goose, guinea, quail, RATITES or turkey.
20
21
“Egg” means the shell EGG of avian species such as chicken, duck,
(2)
“Egg” does not include:
22
(a)
A BALUT;
23
(b)
The egg of reptile species such as alligator; or
8
07.10.13
(c)
1
An EGG PRODUCT.
2
Egg Product.
3
(1)
“Egg Product” means all, or a portion of, the contents found inside
EGGS
4
separated from the shell and pasteurized in a FOOD PROCESSING PLANT, with
5
or without added ingredients, intended for human consumption, such as
6
dried, frozen or liquid eggs.
7
8
9
(2)
“Egg Product” does not include FOOD which contains EGGS only in a
relatively small proportion such as cake mixes.
“Employee” means the PERMIT HOLDER, PERSON IN CHARGE, FOOD EMPLOYEE,
10
PERSON
having supervisory or management duties,
11
member, volunteer, PERSON performing work under contractual agreement, or other
12
PERSON
13
“Enterohemorrhagic Escherichia coli” (EHEC) means E. coli which cause
14
hemorrhagic colitis, meaning bleeding enterically or bleeding from the intestine. The
15
term is typically used in association with E. coli that have the capacity to produce
16
Shiga toxins and to cause attaching and effacing lesions in the intestine. EHEC is a
17
subset of STEC, whose members produce additional virulence factors. Infections
18
with EHEC may be asymptomatic but are classically associated with bloody diarrhea
19
(hemorrhagic colitis) and hemolytic uremic syndrome (HUS) or thrombotic
20
thrombocytopenic purpura (TTP). Examples of serotypes of EHEC include: E.
21
coliO157:H7; E. coli O157:NM; E. coli O26:H11; E. coli O145:NM; E. coli
22
O103:H2; or E. coli O111:NM. Also see SHIGA TOXIN-PRODUCING E. COLI.
23
“EPA” means the U.S. Environmental Protection Agency.
PERSON
on the payroll, family
working in a FOOD ESTABLISHMENT.
9
07.10.13
1
Equipment.
2
(1)
“Equipment” means an article that is used in the operation of a
3
ESTABLISHMENT
4
mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table,
5
TEMPERATURE MEASURING DEVICE
6
WAREWASHING machine.
7
(2)
such as a freezer, grinder, hood, ice maker,
FOOD
for ambient air,
MEAT
block,
VENDING MACHINE,
or
“Equipment” does not include apparatuses used for handling or storing
8
large quantities of
9
cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets,
PACKAGED FOODS
that are received from a supplier in a
10
racks, and skids.
11
“Exclude” means to prevent a
12
ESTABLISHMENT
13
“FDA” means the U.S. Food and Drug Administration.
14
Fish.
15
(1)
PERSON
from working as an
EMPLOYEE
in a
FOOD
or entering a FOOD ESTABLISHMENT as an EMPLOYEE.
“Fish” means fresh or saltwater finfish, crustaceans and other forms of
16
aquatic life (including alligator, frog, aquatic turtle, jellyfish, sea cucumber,
17
and sea urchin and the roe of such animals) other than birds or mammals,
18
and all mollusks, if such animal life is intended for human consumption.
19
20
(2)
“Fish” includes an edible human FOOD product derived in whole or in
part from FISH, including FISH that have been processed in any manner.
21
“Food” means a raw, cooked, or processed edible substance, ice,
22
ingredient used or intended for use or for sale in whole or in part for human
23
consumption, or chewing gum.
10
BEVERAGE,
or
1
07.10.13
“Foodborne disease outbreak” means the occurrence of two or more cases of a
2
similar illness resulting from the ingestion of a common FOOD.
3
“Food-contact surface” means:
4
(1)
5
6
A surface of
EQUIPMENT
or a
UTENSIL
with which
FOOD
normally comes into
contact; or
(2)
A surface of EQUIPMENT or a UTENSIL from which FOOD may drain, drip,
7
or splash:
8
(a)
Into a FOOD, or
9
(b)
Onto a surface normally in contact with FOOD.
10
“Food employee” means an individual working at
11
PACKAGED, UNPACKAGED FOOD, FOOD EQUIPMENT
12
SURFACES.
13
Food Establishment.
14
(1)
or
FOOD ESTABLISHMENTS
UTENSILS,
or
with
FOOD-CONTACT
“Food establishment” means an operation that stores, prepares, packages,
15
serves, vends food directly to the consumer, or otherwise provides FOOD for
16
human consumption:
17
(a)
Such as a restaurant; satellite or catered feeding location; catering
18
operation if the operation provides FOOD directly to a CONSUMER or to a
19
conveyance used to transport people; market; vending location;
20
conveyance used to transport people; institution; or FOOD bank; and
21
(b)
That relinquishes possession of
FOOD
to a
CONSUMER
directly, or
22
indirectly through a delivery service such as home delivery of grocery
23
orders or restaurant takeout orders, or delivery service that is provided
11
07.10.13
1
2
by common carriers.
(2)
3
“Food establishment” includes:
(a)
An element of the operation such as a transportation vehicle or a
4
central preparation facility that supplies a vending location or satellite
5
feeding location unless the vending or feeding location is permitted by
6
the REGULATORY AUTHORITY; and
7
(b)
An operation that is conducted in a mobile, stationary, temporary, or
8
permanent facility or location; where consumption is on or off the
9
PREMISES;
10
11
(3)
“Food establishment” does not include:
(a)
12
13
A produce stand that only offers whole, uncut fresh fruits and
vegetables;
(b)
14
15
and regardless of whether there is a charge for the FOOD.
A
FOOD PROCESSING PLANT;
PREMISES
(c)
including those that are located on the
of a FOOD ESTABLISHMENT;
A kitchen in a private home if only
FOOD
that is not
POTENTIALLY
16
HAZARDOUS (TIME/TEMPERATURE CONTROL FOR SAFETY) FOOD, is prepared
17
for sale or service at a function such as a religious or charitable
18
organization's bake sale if allowed by
19
informed by a clearly visible placard at the sales or service location
20
that the FOOD is prepared in a kitchen that is not subject to regulation
21
and inspection by the REGULATORY AUTHORITY;
22
23
(d)
LAW
and if the
CONSUMER
is
An area where FOOD that is prepared as specified in Subparagraph
(3)(c) of this definition is sold or offered for human consumption;
12
1
(e)
07.10.13
A kitchen in a private home, such as a small family day-care provider;
2
or a bed-and-breakfast operation that prepares and offers
3
guests if the home is owner occupied, the number of available guest
4
bedrooms does not exceed 6, breakfast is the only meal offered, the
5
number of guests served does not exceed 18, and THE CONSUMER is
6
informed by statements contained in published advertisements, mailed
7
brochures, and placards posted at the registration area that the FOOD
8
is prepared in a kitchen that is not regulated and inspected by the
9
REGULATORY AUTHORITY;
10
(f)
FOOD
to
or
A private home that receives catered or home-delivered FOOD.
11
“Food processing plant” means a commercial operation that manufactures,
12
packages, labels, or stores
13
sale or distribution to other business entities such as
14
FOOD ESTABLISHMENTS.
15
Game Animal.
16
(1)
FOOD
for human consumption, and provides
FOOD
FOOD PROCESSING PLANTS
“Game animal” means an animal, the products of which are
FOOD,
for
or
that is
17
not classified as livestock, sheep, swine, goat, horse, mule, or other equine in
18
9 CFR 301.2 Definitions, or as Poultry, or FISH.
19
(2)
“Game animal” includes mammals such as reindeer, elk, deer, antelope,
20
water buffalo, bison, rabbit, squirrel, opossum, raccoon, nutria, or muskrat,
21
and nonaquatic reptiles such as land snakes.
22
(3)
“Game animal” does not include RATITES.
23
“General use pesticide” means a pesticide that is not classified by EPA for
13
1
07.10.13
restricted use as specified in 40 CFR 152.175. Pesticides classified for restricted
2
use.
3
“Grade A standards” means the requirements of the United States Public Health
4
Service/FDA “ Grade A Pasteurized Milk Ordinance” with which certain fluid and dry
5
milk and milk products comply.
6
“HACCP plan” means a written document that delineates the formal procedures for
7
following the HAZARD Analysis and CRITICAL CONTROL POINT principles developed by
8
The National Advisory Committee on Microbiological Criteria for Foods.
9
Handwashing Sink.
10
(1)
“Handwashing sink” means a lavatory, a basin or vessel for washing, a
11
wash basin, or a
12
hygiene and designed for the washing of the hands.
PLUMBING FIXTURE
especially placed for use in personal
13
(2)
“Handwashing sink” includes an automatic handwashing facility.
14
“Hazard” means a biological, chemical, or physical property that may cause an
15
unacceptable CONSUMER health RISK.
16
“Health practitioner” means a physician licensed to practice medicine, or if allowed
17
by LAW, a nurse practitioner, physician assistant, or similar medical professional.
18
“Hermetically sealed container” means a container that is designed and intended
19
to be secure against the entry of microorganisms and, in the case of low acid
20
canned FOODS, to maintain the commercial sterility of its contents after processing.
21
“Highly susceptible population” means PERSONS who are more likely than other
22
people in the general population to experience foodborne disease because they are:
23
(1)
Immunocompromised; preschool age children, or older adults; and
14
1
(2)
Obtaining
FOOD
07.10.13
at a facility that provides services such as custodial care,
2
health care, or assisted living, such as a child or adult day care center,
3
kidney dialysis center, hospital or nursing home, or nutritional or socialization
4
services such as a senior center.
5
“Imminent health hazard” means a significant threat or danger to health that is
6
considered to exist when there is evidence sufficient to show that a product,
7
practice, circumstance, or event creates a situation that requires immediate
8
correction or cessation of operation to prevent injury based on:
9
(1)
The number of potential injuries, and
10
(2)
The nature, severity, and duration of the anticipated injury.
11
“Injected” means manipulating a MEAT so that infectious or toxigenic
12
microorganisms may be introduced from its surface to its interior through tenderizing
13
with deep penetration or injecting the
14
referred to as “injecting,” “pinning,” or “stitch pumping.”
15
Juice.
16
(1)
MEAT
such as by processes which may be
“Juice” means the aqueous liquid expressed or extracted from one
17
or more fruits or vegetables, purées of the edible portions of one or
18
more fruits or vegetables, or any concentrates of such liquid or purée.
19
(2)
“Juice” does not include, for purposes of HACCP, liquids, purées, or
20
concentrates that are not used as
21
BEVERAGES.
BEVERAGES
or ingredients of
22
“Kitchenware” means FOOD preparation and storage UTENSILS.
23
“Law” means applicable local, state, and federal statutes, regulations, and
15
07.10.13
1
ordinances.
2
“Linens” means fabric items such as cloth hampers, cloth napkins, table cloths,
3
wiping cloths, and work garments including cloth gloves.
4
Major Food Allergen.
5
(1)
“Major food allergen” means:
(a)
6
Milk, EGG, fish (such as bass, flounder, cod, and including crustacean
7
shellfish such as crab, lobster, or shrimp), tree nuts (such as almonds,
8
pecans, or walnuts), wheat, peanuts, and soybeans; or
9
(b)
10
11
A
FOOD
ingredient that contains protein derived from a
FOOD,
as
specified in Subparagraph (1)(a) of this definition.
(2)
12
“Major food allergen” does not include:
(a)
Any highly refined oil derived from a FOOD specified in Subparagraph
13
(1)(a) of this definition and any ingredient derived from such highly
14
refined oil; or
15
(b)
Any ingredient that is exempt under the petition or notification process
16
specified in the Food Allergen Labeling and Consumer Protection Act
17
of 2004 (Public Law 108-282).
18
“Meat” means the flesh of animals used as
19
cattle, swine, sheep, or goats and other edible animals, except FISH, POULTRY, and
20
wild GAME ANIMALS as specified under Subparagraphs 3-201.17(A)(3) and (4).
21
“mg/L” means milligrams per liter, which is the metric equivalent of parts per million
22
(ppm).
23
“Molluscan shellfish” means any edible species of fresh or frozen oysters, clams,
16
FOOD
including the dressed flesh of
1
07.10.13
mussels, and scallops or edible portions thereof, except when the scallop product
2
consists only of the shucked adductor muscle.
3
Packaged.
4
(1)
“Packaged” means bottled, canned, cartoned, securely bagged, or securely
5
wrapped, whether PACKAGED in a FOOD ESTABLISHMENT or a FOOD PROCESSING
6
PLANT.
7
(2)
“Packaged” does not include a wrapper, carry-out box, or other nondurable
8
container used to containerize
9
protection during service and receipt of the FOOD by the CONSUMER.
10
“Permit” means the document issued by the REGULATORY AUTHORITY that authorizes
11
a PERSON to operate a FOOD ESTABLISHMENT.
12
“Permit holder” means the entity that:
13
(1)
14
FOOD
with the purpose of facilitating
FOOD
Is legally responsible for the operation of the FOOD ESTABLISHMENT such as
the owner, the owner's agent, or other PERSON; and
15
(2)
Possesses a valid PERMIT to operate a FOOD ESTABLISHMENT.
16
“Person” means an association, a corporation, individual, partnership, other legal
17
entity, government, or governmental subdivision or agency.
18
“Person in charge” means the individual present at a FOOD ESTABLISHMENT who is
19
responsible for the operation at the time of inspection.
20
Personal Care Items.
21
(1)
“Personal care items” means items or substances that may be poisonous,
22
toxic, or a source of contamination and are used to maintain or enhance a
23
PERSON'S
health, hygiene, or appearance.
17
1
(2)
07.10.13
“Personal care items” include items such as medicines; first aid supplies;
2
and other items such as cosmetics, and toiletries such as toothpaste and
3
mouthwash.
4
“pH” means the symbol for the negative logarithm of the hydrogen ion
5
concentration, which is a measure of the degree of acidity or alkalinity of a
6
solution.
7
Values between 0 and 7 indicate acidity and values between 7 and 14 indicate
8
alkalinity. The value for pure distilled water is 7, which is considered neutral.
9
“Physical facilities” means the structure and interior surfaces of a
FOOD
10
ESTABLISHMENT
11
attachments such as light fixtures and heating or air conditioning system vents.
12
“Plumbing fixture” means a receptacle or device that:
13
(1)
14
15
including accessories such as soap and towel dispensers and
Is permanently or temporarily connected to the water distribution system of
the PREMISES and demands a supply of water from the system; or
(2)
16
Discharges used water, waste materials, or
SEWAGE
directly or indirectly to
the drainage system of the PREMISES.
17
“Plumbing system” means the water supply and distribution pipes;
18
FIXTURES
19
building drains, including their respective connections, devices, and appurtenances
20
within the PREMISES; and water-treating EQUIPMENT.
21
“Poisonous or toxic materials” means substances that are not intended for
22
ingestion and are included in 4 categories:
23
(1)
PLUMBING
and traps; soil, waste, and vent pipes; sanitary and storm sewers and
Cleaners and SANITIZERS, which include cleaning and SANITIZING agents and
18
07.10.13
agents such as caustics, acids, drying agents, polishes, and other chemicals;
1
2
(2)
3
4
Pesticides, except SANITIZERS, which include substances such as insecticides
and rodenticides;
(3)
Substances necessary for the operation and maintenance of the
5
establishment such as nonfood grade lubricants and
6
that may be deleterious to health; and
7
(4)
PERSONAL CARE ITEMS
Substances that are not necessary for the operation and maintenance of the
8
establishment and are on the
9
products and paints.
PREMISES
for retail sale, such as petroleum
10
Potentially Hazardous Food (Time/Temperature Control for Safety Food).
11
(1)
“Potentially hazardous food (time/temperature control for safety food)”
12
means a FOOD that requires time/temperature control for safety (TCS) to limit
13
pathogenic microorganism growth or toxin formation.
14
(2)
“Potentially hazardous food (time/temperature control for safety food)”
15
includes:
16
(a)
An animal FOOD that is raw or heat-treated; a plant FOOD that is heat-
17
treated or consists of raw seed sprouts, cut melons, cut tomatoes or
18
mixtures of cut tomatoes that are not modified in a way so that they
19
are unable to support pathogenic microorganism growth or toxin
20
formation, or garlic-in-oil mixtures that are not modified in a way that
21
results in mixtures that do not support pathogenic microorganism
22
growth or toxin formation; and
23
(b)
Except as specified in Subparagraph (3)(d) of this definition, a FOOD
19
1
07.10.13
that because of the interaction of its AW and PH values is designated
2
as Product Assessment Required (PA) in Table A or B of this
3
definition:
4
5
6
7
Table A. Interaction of PH and AW for control of spores in
destroy vegetative cells and subsequently PACKAGED
8
4.6 or less
> 4.6 - 5.6
> 5.6
AW values
PH
FOOD
heat-treated to
values
9
10
<0.92
non-PHF*/nonTCS FOOD**
non-PHF/nonTCS FOOD
non-PHF/nonTCS FOOD
11
12
> 0.92 - .95
non-PHF/nonTCS FOOD
non-PHF/nonTCS FOOD
PA***
13
14
> 0.95
non-PHF/nonTCS FOOD
PA
PA
15
16
17
18
19
20
21
22
23
* PHF means POTENTIALLY HAZARDOUS FOOD
** TCS FOOD means TIME/TEMPERATURE CONTROL FOR SAFETY FOOD
*** PA means Product Assessment required
Table B. Interaction of PH and AW for control of vegetative cells and spores in FOOD
not heat-treated or heat-treated but not PACKAGED
AW values
PH
< 4.2
values
4.2 - 4.6
> 4.6 - 5.0
> 5.0
24
25
< 0.88
non-PHF*/nonTCS food**
non-PHF/nonTCS food
non-PHF/nonTCS food
26
27
0.88 – 0.90
non-PHF/nonTCS food
non-PHF/nonTCS food
non-PHF/nonTCS food
28
29
> 0.90 – 0.92
non-PHF/nonTCS food
non-PHF/nonTCS food
PA
PA
30
31
> 0.92
on-PHF/nonTCS food
PA
PA
32
33
34
PA
* PHF means POTENTIALLY HAZARDOUS FOOD
** TCS FOOD means TIME/TEMPERATURE CONTROL FOR SAFETY FOOD
*** PA means Product Assessment required
20
non-PHF/nonTCS food
PA***
1
(3)
07.10.13
“Potentially hazardous food (time/temperature control for safety food)”
2
does not include:
3
(a)
An air-cooled hard-boiled
EGG
with shell intact, or an
EGG
with shell
4
intact that is not hard-boiled, but has been pasteurized to destroy all
5
viable salmonellae;
6
(b)
A
FOOD
in an unopened
that is
HERMETICALLY SEALED CONTAINER
7
commercially processed to achieve and maintain commercial sterility
8
under conditions of non-refrigerated storage and distribution;
9
(c)
A FOOD that because of its PH or AW value, or interaction of AW and PH
10
values, is designated as a non-PHF/non-TCS FOOD in Table A or B of
11
this definition;
12
(d)
A
FOOD
that is designated as Product Assessment Required (PA) in
13
Table A or B of this definition and has undergone a Product
14
Assessment showing that the growth or toxin formation of pathogenic
15
microorganisms that are reasonably likely to occur in that
16
precluded due to:
17
(i)
Intrinsic factors including added or natural characteristics of the
18
FOOD
19
acidulants, or nutrients,
20
(ii)
FOOD Is
such as preservatives, antimicrobials, humectants,
Extrinsic factors including environmental or operational factors
21
that affect the FOOD such as packaging, modified atmosphere
22
such as
23
temperature range of storage and use, or
REDUCED OXYGEN PACKAGING,
21
shelf life and use, or
07.10.13
1
(iii)
(e)
2
A
A combination of intrinsic and extrinsic factors; or
FOOD
that does not support the growth or toxin formation of
3
pathogenic microorganisms in accordance with one of the
4
Subparagraphs (3)(a) - (3)(d) of this definition even though the FOOD
5
may contain a pathogenic microorganism or chemical or physical
6
contaminant at a level sufficient to cause illness or injury.
7
“Poultry” means:
8
(1)
9
squabs), whether live or dead, as defined in 9 CFR 381.1 Poultry Products
10
11
Any domesticated bird (chickens, turkeys, ducks, geese, guineas, RATITES, or
Inspection Regulations Definitions, Poultry; and
(2)
Any migratory waterfowl or game bird, pheasant, partridge, quail, grouse, or
12
pigeon, whether live or dead, as defined in 9 CFR 362.1 Voluntary Poultry
13
Inspection Regulations, Definitions.
14
“Premises” means:
15
(1)
16
17
The
PHYSICAL FACILITY,
its contents, and the contiguous land or property
under the control of the PERMIT HOLDER; or
(2)
The PHYSICAL FACILITY, its contents, and the land or property not described in
18
Subparagraph (1) of this definition if its facilities and contents are under the
19
control of the PERMIT HOLDER and may impact FOOD ESTABLISHMENT personnel,
20
facilities, or operations, and a FOOD ESTABLISHMENT is only one component of
21
a larger operation such as a health care facility, hotel, motel, school,
22
recreational camp, or prison.
23
“Primal cut” means a basic major cut into which carcasses and sides of MEAT are
22
07.10.13
1
separated, such as a beef round, pork loin, lamb flank, or veal breast.
2
“Public water system” has the meaning stated in 40 CFR 141 National Primary
3
Drinking Water Regulations.
4
“Ratite” means a flightless bird such as an emu, ostrich, or rhea.
5
Ready-to-Eat Food.
6
(1)
7
“Ready-to-eat food” means FOOD that:
(a)
Is in a form that is edible without additional preparation to achieve
8
FOOD safety, as specified under one of the following: ¶ 3-401.11(A) or
9
(B), § 3-401.12, or § 3-402.11, or as specified in ¶ 3-401.11(C); or
(b)
10
11
as specified in Subparagraphs 3-401.11(D)(1) and (2); or
12
(c)
13
(d)
15
17
(2)
“Ready-to-eat food” includes:
(a)
(b)
FOOD
that is cooked as specified under § 3-401.11 or
Raw fruits and vegetables that are washed as specified under §
3-302.15;
(c)
22
23
Raw animal
3-401.12, or frozen as specified under § 3-402.11;
20
21
May receive additional preparation for palatability or aesthetic,
epicurean, gastronomic, or culinary purposes.
18
19
Is prepared in accordance with a variance that is granted as specified
in Subparagraphs 3-401.11(D) and (3); and
14
16
Is a raw or partially cooked animal FOOD and the consumer is advised
Fruits and vegetables that are cooked for hot holding, as specified
under § 3-401.13;
(d)
All
POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR
23
07.10.13
that is cooked to the temperature and time required for
1
SAFETY FOOD)
2
the specific FOOD under Subpart 3-401 and cooled as specified under
3
§ 3-501.14;
4
(e)
Plant FOOD for which further washing, cooking, or other processing is
5
not required for
6
shells, if naturally present are removed;
7
(f)
8
FOOD
safety, and from which rinds, peels, husks, or
Substances derived from plants such as spices, seasonings, and
sugar;
9
(g)
10
A bakery item such as bread, cakes, pies, fillings, or icing for which
further cooking is not required for FOOD safety;
11
(h)
The following products that are produced in accordance with USDA
12
guidelines and that have received a lethality treatment for pathogens:
13
dry, fermented sausages, such as dry salami or pepperoni; salt-cured
14
MEAT
15
ham, and Parma ham; and dried MEAT and POULTRY products, such as
16
jerky or beef sticks; and
17
(i)
and
POULTRY
products, such as prosciutto ham, country cured
FOODS manufactured as specified in 21 CFR Part 113, Thermally
18
Processed Low-Acid Foods Packaged in Hermetically Sealed
19
Containers.
20
Reduced Oxygen Packaging.
21
(1)
22
23
“Reduced oxygen packaging” means:
(a)
The reduction of the amount of oxygen in a
PACKAGE
by removing
oxygen; displacing oxygen and replacing it with another gas or
24
1
07.10.13
combination of gases; or otherwise controlling the oxygen content to a
2
level below that normally found in the atmosphere (approximately 21%
3
at sea level); and
4
(b)
A process as specified in Subparagraph (1)(a) of this definition that
5
involves a
6
Listeria monocytogenes require control in the final PACKAGED form.
7
8
(2)
for which the
HAZARDS
Clostridium botulinum or
“Reduced oxygen packaging” includes:
(a)
9
Vacuum PACKAGING, in which air is removed from a PACKAGE of FOOD
and the
10
11
FOOD
PACKAGE
is
HERMETICALLY SEALED
so that a vacuum remains
inside the PACKAGE;
(b)
Modified atmosphere
PACKAGING,
in which the atmosphere of a
12
PACKAGE
13
air but the atmosphere may change over time due to the permeability
14
of the
15
atmosphere PACKAGING includes reduction in the proportion of oxygen,
16
total replacement of oxygen, or an increase in the proportion of other
17
gases such as carbon dioxide or nitrogen;
18
(c)
of FOOD is modified so that its composition is different from
PACKAGING
material or the respiration of the
Controlled atmosphere
of
PACKAGING,
FOOD.
Modified
in which the atmosphere of a
19
PACKAGE
20
composition is different from air, and continuous control of that
21
atmosphere is maintained, such as by using oxygen cavengers or a
22
combination of total replacement of oxygen, nonrespiring FOOD, and
23
impermeable PACKAGING material;
FOOD
is modified so that until the PACKAGE is opened, its
25
1
(d)
Cook chill
PACKAGING,
in which cooked
FOOD
07.10.13
is hot filled into
2
impermeable bags which have the air expelled and are then sealed or
3
crimped closed. The bagged FOOD is rapidly chilled and refrigerated
4
at temperatures that inhibit the growth of psychotropic pathogens; or
5
(e)
Sous vide PACKAGING, in which raw or partially cooked FOOD is placed
6
in a hermetically sealed, impermeable bag, cooked in the bag, rapidly
7
chilled, and refrigerated at temperatures that inhibit the growth of
8
psychotropic pathogens.
9
“Refuse” means solid waste not carried by water through the SEWAGE system.
10
“Regulatory authority” means the Department of Public Health and Social
11
Services and its authorized representatives having jurisdiction over the
12
ESTABLISHMENT.
13
“Reminder” means a written statement concerning the health
14
animal FOODS raw, undercooked, or without otherwise being processed to eliminate
15
pathogens.
16
“Re-service” means the transfer of
17
CONSUMER
18
another PERSON.
19
“Restrict” means to limit activities of
20
transmitting a disease that is transmissible through
21
does not work with exposed FOOD, clean EQUIPMENT, UTENSILS, LINENS, or unwrapped
22
SINGLE-SERVICE
FOOD
RISK
FOOD EMPLOYEE
26
of consuming
that is unused and returned by a
after being served or sold and in the possession of the
or SINGLE-USE ARTICLES.
FOOD
CONSUMER,
so that there is no
FOOD
and the
RISK
to
of
FOOD EMPLOYEE
1
07.10.13
“Restricted egg” means any check, dirty EGG, incubator reject, inedible, leaker, or
2
loss as defined in 9 CFR 590.
3
“Restricted use pesticide” means a pesticide product that contains the active
4
ingredients specified in 40 CFR 152.175 Pesticides classified for restricted use, and
5
that is limited to use by or under the direct supervision of a certified applicator.
6
“Risk” means the likelihood that an adverse health effect will occur within a
7
population as a result of a HAZARD in a FOOD.
8
“Safe material” means:
9
(1)
An article manufactured from or composed of materials that may not
10
reasonably be expected to result, directly or indirectly, in their becoming a
11
component or otherwise affecting the characteristics of any FOOD;
12
(2)
13
14
15
An additive that is used as specified in § 409 or 706 of the Federal Food,
Drug, and Cosmetic Act; or
(3)
Other materials that are not
ADDITIVES
and that are used in conformity with
applicable regulations of the Food and Drug Administration.
16
“Sanitization” means the application of cumulative heat or chemicals on cleaned
17
FOOD-CONTACT SURFACES
18
reduction of 5 logs, which is equal to a 99.999% reduction, of representative disease
19
microorganisms of public health importance.
20
“Sealed” means free of cracks or other openings that allow the entry or passage of
21
moisture.
22
“Service animal” means an animal such as a guide dog, signal dog, or other
23
animal individually trained to provide assistance to an individual with a disability.
that, when evaluated for efficacy, is sufficient to yield a
27
1
07.10.13
“Servicing area” means an operating base location to which a mobile FOOD
2
ESTABLISHMENT or transportation vehicle returns regularly for such things as vehicle
3
and equipment cleaning, discharging liquid or solid wastes, refilling water tanks and
4
ice bins, and boarding FOOD.
5
“Sewage” means liquid waste containing animal or vegetable matter in suspension
6
or solution and may include liquids containing chemicals in solution.
7
“Shellfish control authority” means a state, federal, foreign, tribal, or other
8
government entity legally responsible for administering a program that includes
9
certification of
MOLLUSCAN SHELLFISH
harvesters and
DEALERS
for interstate
10
commerce.
11
“Shellstock” means raw, in-shell MOLLUSCAN SHELLFISH.
12
“Shiga toxin-producing Escherichia coli” (STEC) means any E. coli capable of
13
producing Shiga toxins (also called verocytotoxins or “Shiga-like” toxins). Examples
14
of serotypes of STEC include both O157 and non-O157 E. coli.
15
ENTEROHEMORRHAGIC ESCHERICHIA COLI.
16
“Shucked shellfish” means
17
removed.
18
“Single-service articles” means TABLEWARE, carry-out UTENSILS, and other items
19
such as bags, containers, placemats, stirrers, straws, toothpicks, and wrappers that
20
are designed and constructed for one time, one
21
intended for discard.
22
Single-Use Articles.
23
(1)
MOLLUSCAN SHELLFISH
Also see
that have one or both shells
PERSON
use after which they are
“Single-use articles” means UTENSILS and bulk FOOD containers designed
28
07.10.13
1
2
and constructed to be used once and discarded.
(2)
“Single-use articles” includes items such as wax paper, butcher paper,
3
plastic wrap, formed aluminum FOOD containers, jars, plastic tubs or buckets,
4
bread wrappers, pickle barrels, ketchup bottles, and number 10 cans which
5
do not meet the materials, durability, strength, and cleanability specifications
6
under Sections 4-101.11, 4-201.11, and 4-202.11 for multiuse UTENSILS.
7
“Slacking” means the process of moderating the temperature of a FOOD such as
8
allowing a FOOD to gradually increase from a temperature of -23oC (-10oF) to -4oC
9
(25oF) in preparation for deep-fat frying or to facilitate even heat penetration during
10
the cooking of previously block-frozen FOOD such as shrimp.
11
“Smooth” means:
12
(1)
13
14
cleanability equal to or exceeding that of (100 grit) number 3 stainless steel;
(2)
15
16
17
A FOOD-CONTACT SURFACE having a surface free of pits and inclusions with a
A nonFOOD-CONTACT SURFACE of EQUIPMENT having a surface equal to that of
commercial grade hot-rolled steel free of visible scale; and
(3)
A floor, wall, or ceiling having an even or level surface with no roughness or
projections that render it difficult to clean.
18
“Tableware” means eating, drinking, and serving
19
flatware including forks, knives, and spoons; hollowware including bowls, cups,
20
serving dishes, and tumblers; and plates.
21
“Temperature measuring device” means a thermometer, thermocouple,
22
thermistor, or other device that indicates the temperature of FOOD, air, or water.
23
Temporary food establishment.
29
UTENSILS
for table use such as
1
(1)
“Temporary food establishment” means a
07.10.13
that
FOOD ESTABLISHMENT
2
operates for a period of no more than 14 consecutive days in conjunction
3
with a single event or celebration.
4
(2)
5
“Temporary food establishment” does not include:
(a)
A “temporary food service establishment” that is referenced in §
6
21102(f) of Chapter 21, Title 10 GCA, and is defined as a
7
ESTABLISHMENT,
8
consecutive days in conjunction with a single event or celebration
9
which shall meet all the requirements of this Code; or
10
(b)
11
FOOD
that operates for a period of no more than 180
Any other FOOD ESTABLISHMENT that operates for a period of no more
than 180 consecutive days but less than 365 consecutive days.
12
“USDA” means the U.S. Department of Agriculture.
13
“Utensil” means a
14
preparation, transportation, dispensing, sale, or service of
15
KITCHENWARE or TABLEWARE
16
used in contact with
17
MEASURING DEVICES;
18
FOOD.
19
“Variance” means a written document issued by the REGULATORY AUTHORITY that
20
authorizes a modification or waiver of one or more requirements of this Code if, in
21
the opinion of the
22
result from the modification or waiver.
23
“Vending machine” means a self-service device that, upon insertion of a coin,
FOOD-CONTACT
implement or container used in the storage,
FOOD,
such as
that is multiuse, SINGLE-SERVICE, or SINGLE-USE; gloves
FOOD;
temperature sensing probes of
FOOD TEMPERATURE
and probe-type price or identification tags used in contact with
REGULATORY AUTHORITY,
30
a health
HAZARD
or nuisance will not
1
07.10.13
paper currency, token, card, or key, or by optional manual operation, dispenses unit
2
servings of
3
device between each vending operation.
4
“Vending machine location” means the room, enclosure, space, or area where
5
one or more VENDING MACHINES are installed and operated and includes the storage
6
areas and areas on the PREMISES that are used to service and maintain the VENDING
7
MACHINES.
8
“Warewashing” means the cleaning and SANITIZING of UTENSILS and FOOD-
9
CONTACT SURFACES
FOOD
in bulk or in packages without the necessity of replenishing the
of EQUIPMENT.
10
“Whole-muscle, intact beef” means whole muscle beef that is not injected,
11
mechanically tenderized, reconstructed, or scored and marinated, from which
12
beef steaks may be cut.
31
07.10.13
1
Guam Annex
1
2
Public Health Reasons
3
CHAPTER 1
PURPOSE AND DEFINITIONS
4
CHAPTER 2
MANAGEMENT AND PERSONNEL
5
CHAPTER 3
FOOD
6
CHAPTER 4
EQUIPMENT, UTENSILS, AND LINENS
7
CHAPTER 5
WATER, PLUMBING, AND WASTE
8
CHAPTER 6
PHYSICAL FACILITIES
9
CHAPTER 7
POISONOUS OR TOXIC MATERIALS
10
CHAPTER 8
COMPLIANCE AND ENFORCEMENT
11
12
Chapter 1 Purpose and Definitions
13
Applicability and
14
Terms Defined
15
(B)
16
The individual definitions in Chapter 1 are not numbered, consistent with current
17
conventions regarding the use of plain language in drafting rules, and with use in
18
national and international standards and some Federal regulations. This facilitates
19
making changes to the definitions as they become necessary in subsequent editions
20
of the Food Code. The intent of the definitions to be binding in terms of the
21
application and interpretation of the Code is clearly stated in Chapter 1.
1-201.10
Statement of Application and Listing
of Terms.
Terms Defined
Guam Food Code Annex 1 – Public Health Reasons
1
07.10.13
1
Accredited Program.
2
Food protection manager certification occurs when individuals demonstrate through
3
a certification program that they have met specified food safety knowledge
4
standards.
5
Food protection certification program accreditation occurs when certification
6
organizations demonstrate through an accreditation program that they have met
7
specified program standards.
8
Accreditation is a conformity assessment process through which organizations that
9
certify individuals may voluntarily seek independent evaluation and listing by an
10
accrediting agency based upon the certifying organization meeting program
11
accreditation standards. Such accreditation standards typically relate to such factors
12
as the certifying organization's structure, mission, policies, procedures, and the
13
defensibility of its examination processes. These standards are intended to affirm or
14
enhance the quality and credibility of the certification process, minimize the potential
15
for conflicts of interest, ensure fairness to candidates for certification and others, and
16
thereby increase public health protection.
17
Program accreditation standards known to be relevant to food protection manager
18
certification programs include those contained in the Standards for Accreditation of
19
Food Protection Manager Certification Programs available from the Conference for
20
Food Protection, 1085 Denio Avenue, Gilroy, CA
21
http://www.foodprotect.org/pdf/standards.pdf.
22
Allowing food protection managers to demonstrate their required food safety
23
knowledge “through passing a test that is part of an accredited program” is
95020-9206 and found at
Guam Food Code Annex 1 – Public Health Reasons
2
1
07.10.13
predicated on the fact that their credentials have been issued by certifying
2
organizations that have demonstrated conformance with rigorous and nationally
3
recognized program standards.
4
Food Establishment and a food processing plant located within the same
5
premises of a Food Establishment
6
Some food businesses perform operations that provide food directly to consumers
7
as a “Food Establishment,” and also supply food to other business entities as a
8
“Food Processing Plant.” Within such a business, those operations that provide
9
food directly to consumers only should be considered part of a “Food Establishment”
10
for the purposes of applying the Food Code while those operations that supply food
11
to other business entities may be subject to other rules and regulations that apply to
12
“Food Processing Plants.” It is essential that the permit holder and persons in
13
charge be aware that regulatory requirements and the appropriate operational
14
practices for “Food Establishments” may differ from those for “Food Processing
15
Plants.”
16
Some facilities and functions may be subject to different regulatory requirements
17
depending on whether that facility or function is regulated as a “Food Establishment”
18
or as a “Food Processing Plant,” or both. Those facilities and functions within a
19
business that are shared by both the “Food Establishment” and “Food Processing
20
Plant” operations, e.g., refrigeration units, dressing room and toilet facilities, food
21
equipment, water and waste systems, pest control, might be subject to similar
22
regulatory requirements.
23
establishments.”
The Food Code is intended to apply to “food
Guam Food Code Annex 1 – Public Health Reasons
3
07.10.13
1
Egg.
2
The definition of egg includes avian species’ shell eggs known to be commercially
3
marketed in the United States. Also included are the eggs of quail and ratites such
4
as ostrich.
5
Not included are baluts. Baluts are considered a delicacy among Philippine and
6
Vietnamese populations. They are derived from fertile eggs, typically duck eggs,
7
subjected to incubation temperatures for a period of time less than necessary for the
8
embryo to hatch resulting in a partially formed embryo within the shell. Under the
9
Egg Products Inspection Act (EPIA), an egg is typically considered adulterated if it
10
has been subjected to incubation. However, in 9 CFR 590.5, baluts are specifically
11
exempted from inspection as eggs under the EPIA.
12
In producing baluts, fertile duck eggs are incubated for approximately 18 days at a
13
temperature of 42.5°C (108.5°F) in incubators with a relatively high humidity.
14
(Complete development and hatching would take place in 28 days.) Under these
15
conditions, the potential for growth of transovarian Salmonella organisms such as S.
16
Enteritidis within the shell, and the potential for an increase in pathogenic microflora
17
on the shell itself, are increased. Where chicken eggs are used in preparing baluts,
18
the incubation period may only be 14 days at an incubation temperature of 37°C
19
(99°F). A balut is a potentially hazardous food (time/temperature control for safety
20
food) subject to time/temperature management including proper cooking and hot
21
and cold holding. Baluts are typically boiled and packed in salt before sale or
22
service. Also, not included in this definition are the eggs of reptile species such as
23
alligators and turtles. Alligator eggs are available for sale in some parts of the
Guam Food Code Annex 1 – Public Health Reasons
4
1
07.10.13
southern United States. In restaurants, the menu item “Alligator Eggs” is sometimes
2
made of alligator egg, but other times is simply a fanciful name for a menu item that
3
may include seafood items such as shrimp, but contains no alligator egg.
4
Sea turtle eggs have been consumed in Asian and Latin American Countries.
5
However, turtle eggs are not mentioned in the definitions section because sea turtles
6
(Loggerhead, East Pacific Green, Leatherback, Hawksbill, Kemp’s Ridley, and Olive
7
Ridley) are protected by The Endangered Species Act of 1973 and therefore may
8
not be sold or consumed. This Act, with respect to turtle eggs, is enforced by the
9
United States Department of Interior, U.S. Fish and Wildlife Service, Washington,
10
D.C.
11
Potentially Hazardous Food (Time/Temperature Control for Safety Food)
12
Potentially hazardous food (PHF/TCS food) is defined in terms of whether or not it
13
requires time/temperature control for safety to limit pathogen growth or toxin
14
formation. The term does not include foods that do not support growth but may
15
contain a pathogenic microorganism or chemical or physical food safety hazard at a
16
level sufficient to cause foodborne illness or injury. The progressive growth of all
17
foodborne pathogens is considered whether slow or rapid.
18
The definition of PHF/TCS food takes into consideration pH, aw, pH and aw
19
interaction, heat treatment, and packaging for a relatively simple determination of
20
whether the food requires time/temperature control for safety. If the food is heat-
21
treated to eliminate vegetative cells, it needs to be addressed differently than a raw
22
product with no, or inadequate, heat treatment. In addition, if the food is packaged
23
after heat treatment to destroy vegetative cells and subsequently packaged to
Guam Food Code Annex 1 – Public Health Reasons
5
1
07.10.13
prevent re-contamination, higher ranges of pH and/or aw can be tolerated because
2
remaining spore-forming bacteria are the only microbial hazards of concern. While
3
foods will need to be cooled slightly to prevent condensation inside the package,
4
they must be protected from contamination in an area with limited access and
5
packaged before temperatures drop below 57°C (135°F). In some foods, it is
6
possible that neither the pH value nor the aw value is low enough by itself to control
7
or eliminate pathogen growth; however, the interaction of pH and aw may be able to
8
accomplish it. This is an example of a hurdle technology. Hurdle technology
9
involves several inhibitory factors being used together to control or eliminate
10
pathogen growth, when they would otherwise be ineffective if used alone.
11
In determining if time/temperature control is required, combination products present
12
their own challenge. A combination product is one in which there are two or more
13
distinct food components and an interface between the two components may have a
14
different property than either of the individual components. A determination must be
15
made about whether the food has distinct components such as pie with meringue
16
topping, focaccia bread, meat salads, or fettuccine alfredo with chicken or whether it
17
has a uniform consistency such as gravies, puddings, or sauces. In these products,
18
the pH at the interface is important in determining if the item is a PHF/TCS food.
19
A well designed inoculation study or other published scientific research should be
20
used to determine whether a food can be held without time/temperature control
21
when:
Guam Food Code Annex 1 – Public Health Reasons
6
1

07.10.13
process technologies other than heat are applied to destroy foodborne
2
pathogens (e.g., irradiation, high pressure processing, pulsed light,
3
ozonation);
4

combination products are prepared; or
5

other extrinsic factors (e.g., packaging/atmospheres) or intrinsic factors (e.g.,
6
redox potential, salt content, antimicrobials) are used to control or eliminate
7
pathogen growth.
8
Before using Tables A and B in paragraph 1-201.10(B) of the definition for
9
“potentially hazardous food (time/temperature control for safety food)” in determining
10
whether a food requires time/temperature control for safety (TCS), answers to the
11
following questions should be considered:
12

Is the intent to hold the food without using time or temperature control?
13
o If the answer is No, no further action is required. The decision tree later
14
in this Annex is not needed to determine if the item is a PHF/TCS food.
15

Is the food raw, or is the food heat-treated?
16

Does the food already require time/temperature control for safety by
17
18
definition in paragraph 1-201.10(B)?

19
20
21
Does a product history with sound scientific rationale exist indicating a safe
history of use?

Is the food processed and packaged so that it no longer requires TCS such
as ultra high temperature (UHT) creamers or shelf-stable canned goods?
Guam Food Code Annex 1 – Public Health Reasons
7
1

What is the pH and aw
07.10.13
of the food in question using an independent
2
laboratory and Association of Official Analytical Chemists (AOAC) methods of
3
analysis?
4
A food designated as product assessment required (PA), in either table should be
5
considered PHF/TCS Food until further study proves otherwise. The PA means that
6
based on the food's pH and aw and whether it was raw or heat-treated or packaged,
7
it has to be considered PHF until inoculation studies or some other acceptable
8
evidence shows that the food is a PHF/TCS food or not. The Food Code requires a
9
variance request to the regulatory authority with the evidence that the food does not
10
require time/temperature control for safety.
11
The Food Code definition designates certain raw plant foods as PHF/TCS food
12
because they have been shown to support the growth of foodborne pathogens in the
13
absence of temperature control and to lack intrinsic factors that would inhibit
14
pathogen growth. Unless product assessment shows otherwise, these designations
15
are supported by Tables A and B. For example:
16
For cut cantaloupe (pH 6.2-7.1, aw > 0.99, not heat-treated), fresh sprouts (pH > 6.5,
17
aw > 0.99, not heat-treated), and cut tomatoes (pH 4.23 - 5.04, aw > 0.99, not heat-
18
treated), Table B indicates that they are considered PHF/TCS foods unless a
19
product assessment shows otherwise.
20
temperature control requirements prescribed in this code for PHF/TCS food will limit
21
the growth of pathogens that may be present in or on the food and may help prevent
22
foodborne illness.
Maintaining these products under the
Guam Food Code Annex 1 – Public Health Reasons
8
1
07.10.13
If a facility adjusts the pH of a food using vinegar, lemon juice, or citric acid for
2
purposes other than flavor enhancement, a variance is required under ¶ 3-
3
502.11(C). A HACCP plan is required whether the food is a PHF/TCS food as in
4
subparagraph 3-502.11(C)(1) or not a PHF/TCS food, as in subparagraph 3-
5
502.11(C)(2). A standardized recipe validated by lab testing for pH and aw would be
6
an appropriate part of the variance request with annual (or other frequency as
7
specified by the regulatory authority) samples tested to verify compliance with the
8
conditions of the variance.
9
More information can be found in the Institute of Food Technologists (IFT) Report,
10
Evaluation and Definition of Potentially Hazardous Foods.
11
Instructions for using the following Decision Tree and Table A and Table B:
12
1.
Does the operator want to hold the food without using time or temperature
13
control?
14
a.
15
No – Continue holding the food at ≤5°C(41°F) or ≥57°C(135°F) for
safety and/or quality.
16
b.
Yes – Continue using the decision tree to identify which table to use to
17
determine whether time/temperature control for safety (TCS) is
18
required.
19
20
2.
Is the food heat-treated?
a.
No – The food is either raw, partially cooked (not cooked to the
21
temperature specified in section 3-401.11 of the Food Code) or
22
treated with some other method other than heat. Proceed to step #3.
Guam Food Code Annex 1 – Public Health Reasons
9
1
b.
07.10.13
Yes – If the food is heat-treated to the required temperature for that
2
food as specified under section 3-401.11 of the Food Code, vegetative
3
cells will be destroyed although spores will survive. Proceed to step
4
#4.
5
3.
6
Is the food treated using some other method?
a.
7
No –The food is raw or has only received a partial cook allowing
vegetative cells and spores to survive. Proceed to step #6.
8
b.
Yes – If a method other than heat is used to destroy pathogens such
9
as irradiation, high pressure processing, pulsed light, ultrasound,
10
inductive heating, or ozonation, the effectiveness of the process
11
needs to be validated by inoculation studies or other means. Proceed
12
to step #5.
13
4.
14
Is it packaged to prevent re-contamination?
a.
15
No – Re-contamination of the product can occur after heat treatment
because it is not packaged. Proceed to step #6.
16
b.
Yes – If the food is packaged immediately after heat treatment to
17
prevent re-contamination, higher ranges of pH and/or aw can be
18
tolerated because spore-forming bacteria are the only microbial
19
hazard. Proceed to step #7.
20
21
5.
Further product assessment or vendor documentation required.
a.
The vendor of this product may be able to supply documentation that
22
inoculation studies indicate the food can be safely held without
23
time/temperature control for safety.
Guam Food Code Annex 1 – Public Health Reasons
10
1
b.
07.10.13
Food prepared or processed using new technologies may be held
2
without time/temperature control provided the effectiveness of the use
3
of such technologies is based on a validated inoculation study.
4
6.
Using the food’s known pH and/or aw values, position the food in the
5
appropriate table.
6
a.
7
Choose the column under “pH values” that contains the pH value of
the food in question.
8
b.
9
Choose the row under “aw values” that contains the aw value of the
food in question.
10
c.
Note where the row and column intersect to identify whether the food
11
is “non-PHF/non-TCS food” and therefore does not require
12
time/temperature control, or whether further product assessment (PA)
13
is required.
14
microorganisms, salt content, or processing methods may allow the
15
product to be held without time/temperature control but an inoculation
16
study is required.
17
7.
18
19
20
Other factors such as redox potential, competitive
Use Table A for foods that are heat-treated and packaged OR use Table B
for foods that are not heat-treated or heat-treated but not packaged.
8.
Determine if the item is non-PHF/non-TCS or needs further product
assessment (PA).
Guam Food Code Annex 1 – Public Health Reasons
11
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
#1 Does the operator want to
hold the food without using time
or temperature control?
NO
YES
No further action required.
#2 Is the food heat-treated?
NO
#4 Is it packaged to
prevent re-contamination?
#3 Is the food treated using some
other method?
YES
YES
NO
NO
#6 Using the food’s known pH
and/or aw values, position the food
in the appropriate table.
#5 Further PA or vendor
documentation required.
#7 Use Table A
#7 Use Table B
Non-PHF/Non-TCS
Food may be held
out of temperature
or time control and
is considered shelfstable.
YES
Product
Assessment
Further PA or
vendor
documentation
required.
Non-PHF/Non-TCS
Food may be held
out of temperature
or time control and
is considered shelfstable.
Guam Food Code Annex 1 – Public Health Reasons
12
Product
Assessment
Further PA or
vendor
documentation
required.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
*
18
** TCS food means Time/Temperature Control for Safety food
19
*** PA means Product Assessment required
1-201.10(B) – Table A and Table B
Table A. Interaction of pH and aw for control of spores in food heat-treated to
destroy vegetative cells and subsequently packaged
aw values
PH values
4.6 or less
> 4.6 - 5.6
> 5.6
≤0.92
non-PHF*/non-TCS
FOOD**
non-PHF/nonTCS FOOD
> 0.92 - .95
non-PHF/non-TCS
non-PHF/nonTCS FOOD
PA***
PA
PA
FOOD
> 0.95
non-PHF/non-TCS
non-PHF/nonTCS FOOD
FOOD
PHF means Potentially Hazardous Food
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
Table B. Interaction of pH and aw for control of vegetative cells and spores in food
not heat-treated or heat-treated but not packaged
aw values
PH values
< 4.2
4.2 - 4.6
> 4.6 - 5.0
> 5.0
< 0.88
0.88 – 0.90
> 0.90 – 0.92
non-PHF*/
non- TCS
FOOD**
non-PHF/
non-TCS
food
non-PHF/
non-TCS
food
non-PHF/ non-PHF/
non-TCS
non-TCS
FOOD
food
non-PHF/
non-TCS
food
non-PHF/
non-TCS
FOOD
> 0.92
non-PHF/
non-TCS
food
non-PHF/
non-TCS food
PA***
PA
PA
PA
PA
non-PHF/
non-TCS
FOOD
PA
* PHF means Potentially Hazardous Food
** TCS food means Time/Temperature Control for Safety food
*** PA means Product Assessment required
Guam Food Code Annex 1 – Public Health Reasons
13
Chapter 2 Management and Personnel
1
2
Responsibility
3
Designation of a person in charge during all hours of operations ensures the
4
continuous presence of someone who is responsible for monitoring and managing
5
all food establishment operations and who is authorized to take actions to ensure
6
that the Code's objectives are fulfilled. During the day-to-day operation of a food
7
establishment, a person who is immediately available and knowledgeable in both
8
operational and Code requirements is needed to respond to questions and concerns
9
and to resolve problems.
2-101.11
Assignment.*
10
In cases where a food establishment has several departments on the premises
11
(e.g., a grocery store with deli, seafood, and produce departments) and the
12
regulatory authority has permitted those departments individually as separate food
13
establishments, it may be unnecessary from a food safety standpoint to staff each
14
department with a separate Person in Charge during periods when food is not being
15
prepared, packaged or served. While activities such as moving food products from
16
a refrigerated display case to the walk-in refrigerator, cleaning the floors, or doing
17
inventory when the department is not busy, do take place during these times, a
18
designated Person in Charge for multiple departments or the entire facility can
19
oversee these operations and be ready to take corrective actions if necessary.
20
Knowledge
21
The designated person in charge who is knowledgeable about foodborne disease
22
prevention, Hazard Analysis and Critical Control Point (HACCP) principles, and
23
Code requirements is prepared to recognize conditions that may contribute to
2-102.11
Demonstration.*
Guam Food Code Annex 1 – Public Health Reasons
14
1
foodborne illness or that otherwise fail to comply with Code requirements, and to
2
take appropriate preventive and corrective actions.
3
There are many ways in which the person in charge can demonstrate competency.
4
Many aspects of the food operation itself will reflect the competency of that person.
5
A dialogue with the person in charge during the inspection process will also reveal
6
whether or not that person is enabled by a clear understanding of the Code and its
7
public health principles to follow sound food safety practices and to produce foods
8
that are safe, wholesome, unadulterated, and accurately represented.
9
The Food Code does not require reporting of uninfected cuts or reporting of covered,
10
protected infected cuts/lesions/boils since no bare hand contact with ready-to-eat
11
(RTE) food is a Code requirement.
12
2-102.20
Food Protection Manager Certification.
13
Many food protection manager certification programs have shared a desire to have
14
the food manager certificates they issue universally recognized and accepted by
15
others – especially by the increasing number of regulatory authorities that require
16
food manager certification.
17
Needed has been a mechanism for regulatory authorities to use in determining
18
which certificates should be considered credible based on which certificate issuing
19
programs meet sound organizational and certification procedures and use
20
defensible processes in their test development and administration.
21
After a multi-year effort involving a diversity of stakeholder groups, the Conference
22
for Food Protection (CFP) completed work on its Standards for Accreditation of
23
Food
Protection
Manager
Certification
Programs
Guam Food Code Annex 1 – Public Health Reasons
15
found
at
1
http://www.foodprotect.org/pdf/standards.pdf. In 2002 the Conference entered into a
2
cooperative agreement with the American National Standards Institute (ANSI) to
3
provide independent third-party evaluation and accreditation of certification bodies
4
determined to be in conformance with these Conference standards. ANSI published
5
its first listing of accredited certifiers in 2003.
6
The Acting Commissioner of the Food and Drug Administration, in his address
7
before the 2004 biennial meeting of the Conference for Food Protection,
8
commended this Conference achievement and encouraged universal acceptance
9
based on the CFP/ANSI accreditation program.
10
Distributed at this meeting was the following letter addressed to the Conference
11
Chair and signed by the Director of FDA’s Center for Food Safety and Applied
12
Nutrition. The letter puts forth the Agency’s basis for its support of universal
13
acceptance of food protection manager certifications.
14
“The 2004 biennial meeting of the Conference for Food Protection is a
15
fitting occasion for FDA’s Center for Food Safety and Applied Nutrition to
16
commend the Conference for its significant achievements in support of State
17
and local food safety programs.
18
The FDA in a Memorandum of Understanding recognizes the Conference for
19
Food Protection as a voluntary national organization qualified to develop
20
standards to promote food protection.
21
contribute to improvements in the model FDA Food Code and help
22
jurisdictions justify, adopt and implement its provisions.
23
Conference mechanisms involving active participation by representatives of
Conference recommendations
Guam Food Code Annex 1 – Public Health Reasons
16
1
diverse stakeholder groups produce consensus standards of the highest
2
quality.
3
Accreditation of Food Protection Manager Certification Programs, and
4
its announcement of the new on-line listing of accredited certifiers of industry
5
food protection managers.
6
Conference standards identify the essential components necessary for a
7
credible certification program.
8
requirements such as detailed criteria for exam development and
9
administration, and responsibilities of the certification organization to
An excellent example is the Conference’s Standards for
Many years in their development, these
Components cover a wide range of
10
candidates and the public.
11
FDA applauds the Conference for this significant achievement, and
12
encourages agencies at all levels of government to accept certificates issued
13
by listed certifiers as meeting their jurisdictions’ food safety knowledge and
14
certification requirements. The American National Standards Institute (ANSI)
15
has independently evaluated these certification programs under an
16
agreement with the Conference for Food Protection. Governments and
17
industry widely recognize and respect ANSI as an accrediting organization.
18
ANSI has found certifiers it lists as accredited (http://www.ansi.org/) under
19
“conformity assessment” – “personnel certification accreditation” to conform
20
to the Conference’s Standards for Accreditation of Food Protection
21
Manager Certification Programs.*
*ANSI’s “Directory of Accredited Personnel Certification Programs utilizing Conference for Food Protection
(CFP) Standards” may be viewed on-line by going to http://www.ansi.org. Select “Accreditation Services” in the
menu on the left. Then select “ANSI Accredited Personnel Certification Bodies and Applicants” in the new left-hand
menu under the heading “Personnel Certification Accreditation.”
Guam Food Code Annex 1 – Public Health Reasons
17
1
The Food Code states the person in charge of a food establishment is
2
accountable for developing, carrying out, and enforcing procedures aimed at
3
preventing food-borne illness. Section 2-102.11 states that one means by
4
which a person in charge may demonstrate required knowledge of food
5
safety is through certification as a food protection manager by passing an
6
examination that is part of an accredited program.
7
FDA encourages food regulatory authorities and others evaluating credentials
8
for food protection managers to recognize the Conference for Food
9
Protection/ANSI means of accrediting certification programs. This procedure
10
provides a means for universal acceptance of individuals who successfully
11
demonstrate knowledge of food safety. The procedure provides officials
12
assurance that food safety certification is based on valid, reliable, and legally
13
defensible criteria.
14
inconvenience and unnecessary expense of repeating training and testing
15
when managers work across jurisdictional boundaries.
16
FDA, along with State, local, tribal, and other Federal agencies and the food
17
industry, share the responsibility for ensuring that our food supply is safe. It
18
is anticipated that this new Conference for Food Protection/ANSI program will
19
lead to enhanced consumer protection, improve the overall level of food
20
safety, and be an important component of a seamless national food safety
21
system.”
22
Duties
2-103.11
In addition, universal acceptance eliminates the
Person in Charge.
Guam Food Code Annex 1 – Public Health Reasons
18
1
A primary responsibility of the person in charge is to ensure compliance with Code
2
requirements. Any individual present in areas of a food establishment where food
3
and food-contact items are exposed presents a potential contamination risk. By
4
controlling who is allowed in those areas and when visits are scheduled and by
5
assuring that all authorized persons in the establishment, such as delivery,
6
maintenance and service personnel, and pest control operators, comply with the
7
Code requirements, the person in charge establishes an important barrier to food
8
contamination.
9
Tours of food preparation areas serve educational and promotional purposes;
10
however, the timing of such visits is critical to food safety. Tours may disrupt
11
standard or routine operational procedures, and the disruption could lead to unsafe
12
food. By scheduling tours during nonpeak hours the opportunities for contamination
13
are reduced.
14
Paragraph (L) “EMPLOYEES are properly trained in FOOD safety as it relates to their
15
assigned duties” allows industry to develop and implement operational-specific
16
training programs for food employees. It is not intended to require that all food
17
employees pass a test that is part of an accredited program.
18
2-2
19
Overall goals
20
The purpose of this section of the Food Code is to reduce the likelihood that certain
21
viral and bacterial agents will be transmitted from infected food workers into food.
22
The agents of concern are known to be readily transmissible via food that has been
23
contaminated by ill food workers, and so for that reason, are the primary focus of the
Employee Health
Guam Food Code Annex 1 – Public Health Reasons
19
1
Employee Health section of the Food Code. However, there are different levels of
2
risk associated with different levels of clinical illness.
3
restrictions and exclusions has, therefore, been designed in a tiered fashion
4
depending on the clinical situation to offer the maximum protection to public health
5
with the minimal disruption to employees and employers.
6
Four levels of illness or potential illness have been identified with the first level
7
being the highest potential risk to public health and the fourth level being the lowest.
8
The first level relates to employees who have specific symptoms (e.g., vomiting,
9
diarrhea, jaundice) while in the workplace. These symptoms are known to be
10
associated commonly with the agents most likely to be transmitted from infected
11
food workers through contamination of food.
12
employees who have been diagnosed with typhoid fever or an infection with
13
hepatitis A virus (within 14 days of symptoms).
14
employees who have been diagnosed with the specific agents that are of concern,
15
but who are not exhibiting symptoms of disease because their symptoms have
16
resolved. The third level relates to employees who are diagnosed with the specific
17
agents, but never develop any gastrointestinal symptoms. The fourth level relates to
18
those individuals who are clinically well but who may have been exposed to a listed
19
pathogen and are within the normal incubation period of disease.
20
The most significant degree of restriction and exclusion applies to the first level of
21
food employee illness. Infected food employees in the first level are likely to be
22
excreting high levels of their infectious pathogen, increasing the chance of
The first level also relates to
The second level relates to
Guam Food Code Annex 1 – Public Health Reasons
20
The structure of the
1
transmission to food products, and thus on to those consuming the food. The first
2
level includes food employees who are:
3

4
Experiencing active symptoms of diarrhea or vomiting – with no
diagnosis,
5

Experiencing jaundice within the last 7 days-- with no diagnosis,
6

Diagnosed with typhoid fever,
7

Diagnosed with hepatitis A within 7 days of jaundice or 14 days of any
8
9
symptoms, or

Experiencing active symptoms of diarrhea or vomiting, and diagnosed
10
with Norovirus, E. coli O157:H7 or other Enterohemorrhagic
11
Escherichia coli (EHEC) or Shiga toxin-producing Escherichia coli
12
(STEC), or Shigella spp. infection.
13
Diagnosis with typhoid fever or hepatitis A virus is included in level 1 because
14
employees diagnosed with these pathogens are likely to be shedding high levels of
15
the pathogen in their stool without exhibiting gastrointestinal symptoms. Peak levels
16
of hepatitis A viral shedding in the feces typically occurs before symptoms appear.
17
Diarrhea and vomiting are reliable indicators of infection with Norovirus, E. coli
18
O157:H7 or other EHEC, and Shigella spp., but are not typical symptoms of
19
typhoid fever or hepatitis A. For example, employees diagnosed with typhoid fever
20
are more likely to experience constipation, rather than diarrhea. Jaundice is also not
21
always reliable as an indicator of a hepatitis A infection because employees can be
22
infected with hepatitis A virus without experiencing jaundice (anicteric employees).
23
Maximum protection to public health requires excluding food employees
Guam Food Code Annex 1 – Public Health Reasons
21
1
suffering from typhoid fever, hepatitis A virus, or specific gastrointestinal symptoms
2
associated with diseases identified as likely to be transmitted through contamination
3
of food (See section 2-201.12, Tables 2-201.12 #1a and #1b in this Annex). This
4
situation describes the highest level of risk in transmitting pathogens to food, or what
5
we would find in the first level.
6
Food employees who have been diagnosed with one of the agents of concern, but
7
are not symptomatic because their symptoms have resolved, are still likely to be
8
carrying the infected agent in their intestinal tract. This makes such employees less
9
likely to spread the agent into food than others who are actually symptomatic, but
10
employees diagnosed with one of the agents of concern still pose an elevated threat
11
to public health. For this reason, there are a series of exclusions (if the employees
12
work in facilities serving highly susceptible populations (HSP)) and restrictions (for
13
non-HSP facilities) depending on the agent involved (See section 2-201.12, Table
14
#2). This situation describes the second level of risk in transmitting pathogens to
15
food.
16
Diagnosed, asymptomatic food employees who never develop symptoms are
17
typically identified during a foodborne illness outbreak investigation through
18
microbiological testing.
19
microbiologically tested, they will remain undetected and could therefore extend the
20
duration of a foodborne illness outbreak through continued contamination of food.
21
The Food Code provides restriction or exclusion guidelines for employees that are
22
identified through microbiological testing with an infection from a listed foodborne
23
pathogen, but are otherwise asymptomatic and clinically well (See section 2-201.12,
If infected and asymptomatic employees are not
Guam Food Code Annex 1 – Public Health Reasons
22
1
Table #3). The exclusion or restriction guidelines are applied until the identified food
2
employees no longer present a risk for foodborne pathogen transmission. This
3
situation describes the third level of risk in transmitting pathogens to food.
4
Some food employees or conditional employees may report a possible exposure to
5
an agent. For example, a food employee may have attended a function at which the
6
food employee ate food that was associated with an outbreak of shigellosis, but the
7
employee remains well. Such individuals fall into the category of having had a
8
potential exposure and present a lower risk to public health than someone who is
9
either symptomatic or who has a definitive diagnosis. They present a level of risk to
10
public health that is greater than if they had not had the exposure. The approach
11
taken in the Food Code to food employees who have had a potential exposure is
12
based on the incubation times (time between exposure and the onset of symptoms)
13
of the various agents. The times chosen for restriction are the upper end of the
14
average incubation periods for the specific agents. The reasoning is that this will
15
restrict food employees only up to the time when it is unlikely they will develop
16
symptoms. As a further protection to public health, it is recommended that such
17
exposed food employees pay particular attention to personal hygiene and report the
18
onset of any symptoms (See section 2-201.12, Table #4). This situation describes
19
the fourth level of risk in transmitting pathogens to food.
20
This structured approach has linked the degree of exclusion and restriction to the
21
degree of risk that an infected food worker will transmit an agent of concern into
22
food. The approach strikes a balance between protecting public health and the
23
needs of the food employee and employer.
Guam Food Code Annex 1 – Public Health Reasons
23
1
The Food Code provisions related to employee health are aimed at removing highly
2
infectious food employees from the work place.
3
recognition of the characteristics of the five important pathogens, and of the risk of
4
disease transmission associated with symptomatic and asymptomatic shedders. The
5
provisions also account for the increased risk associated with serving food to HSP’s
6
and the need to provide extra protection to those populations.
7
The Employee Health section was developed and revised with assistance and input
8
from the Centers for Disease Control and Prevention (CDC) and the U.S. Equal
9
Employment Opportunity Commission (EEOC). The exclusion and restriction criteria
10
are based on communicable disease information, as required by the Americans with
11
Disabilities Act of 1990, in the “The List of Infectious and Communicable Diseases
12
Which are Transmitted through the Food Supply“ published in the Federal Register
13
on October 4, 2004, (Volume 69, Number 191) by the CDC, and from the Control of
14
Communicable Diseases Manual, 18th Ed., David L. Heymann, MD, Editor, by the
15
American Public Health Association, Washington D.C., 2004.
16
17
2-201
They were developed with
Infected Food Employees and Conditional Employees
Practical Applications of Using Subpart 2-201
18
The information provided in Subpart 2-201 is designed to assist food establishment
19
managers and regulatory officials in removing infected food employees when they
20
are at greatest risk of transmitting foodborne pathogens to food.
21
applications of the information in Subpart 2-201 by a food establishment manager
22
may involve using Subpart 2-201 as a basis for obtaining information on the health
23
status of food employees and can also be used as a basis in developing and
Guam Food Code Annex 1 – Public Health Reasons
24
Practical
1
implementing an effective Employee Health Policy. Regulatory officials can benefit
2
by using the information provided below as a basis for determining compliance with
3
Subpart 2-201 during a facility food safety inspection.
4
The development and effective implementation of an employee health policy based
5
on the provisions in Subpart 2-201 may help to prevent foodborne illness associated
6
with contamination of food by ill or infected food employees. The person in charge
7
and food employees should be familiar with and able to provide the following
8
information through direct dialogue or other means when interviewed by facility
9
managers or regulatory officials. Compliance must be based, however, on first hand
10
observations or information and cannot be based solely on responses from the
11
person in charge to questions regarding hypothetical situations or knowledge of the
12
Food Code. Also, when designing and implementing an employee health policy, the
13
following information should be considered and addressed:
14
1.
Does the establishment have an Employee Health Policy? If so, are
15
the food employees aware of the employee health policy, and is it
16
available in written format and readily available for food employees?
17
(Note: A written Employee Health Policy is not a Food Code
18
requirement unless the facility is operating under a pre-approved
19
alternative procedure specified under ¶ 3-301.11(D)).
20
2.
Does the establishment require conditional employees and food
21
employees to report certain illnesses, conditions, symptoms, and
22
exposures?
23
3.
Are the reporting requirements explained to all employees?
Guam Food Code Annex 1 – Public Health Reasons
25
1
4.
2
3
What are the reporting requirements for conditional employees, food
employees, and the food establishment manager?
5.
Are conditional employees asked if they are experiencing certain
4
symptoms or illnesses upon offer of employment? If so, which
5
symptoms or illnesses?
6
6.
If a food employee reports a diagnosis with one of the 5 listed
7
pathogens in the Food Code, what questions are asked of the food
8
employee? (The first question every food manager should ask a food
9
employee who reports diagnosis with a listed pathogen is if the
10
11
employee is currently having any symptoms.)
7.
12
13
diagnosis with one of the listed pathogens?
8.
14
15
What gastrointestinal symptoms would require exclusion of a food
employee from the food establishment?
9.
16
17
Who does the establishment notify when a food employee reports a
What history of exposure is a conditional employee or food employee
required to report?
10.
18
If a food employee reports a gastrointestinal symptom, what criteria
are used to allow the employee to return to work?
19
20
Responsibilities
21
and Reporting
22
Symptoms and
23
Diagnosis
2-201.11
Responsibility of the Person in Charge,
Food Employees and Conditional Employees.*
Guam Food Code Annex 1 – Public Health Reasons
26
1
Proper management of a food establishment operation begins with employing
2
healthy people and instituting a system of identifying employees who present a risk
3
of transmitting foodborne pathogens to food or to other employees. The person in
4
charge is responsible for ensuring all food employees and conditional employees
5
are knowledgeable and understand their responsibility to report listed symptoms,
6
diagnosis with an illness from a listed pathogen, or exposure to a listed pathogen to
7
the person in charge. The person in charge is also responsible for reporting to the
8
regulatory official if a food employee reports a diagnosis with a listed pathogen.
9
This reporting requirement is an important component of any food safety program. A
10
food employee who suffers from any of the illnesses or medical symptoms or has a
11
history of exposure to a listed pathogen in this Code may transmit disease through
12
the food being prepared. The person in charge must first be aware that a food
13
employee or conditional employee is suffering from a disease or symptom listed in
14
the Code before steps can be taken to reduce the chance of foodborne illness.
15
The person in charge may observe some of the symptoms that must be reported.
16
However, food employees and conditional employees share a responsibility for
17
preventing foodborne illness and are obligated to inform the person in charge if they
18
are suffering from any of the listed symptoms, have a history of exposure to one of
19
the listed pathogens, or have been diagnosed with an illness caused by a listed
20
pathogen. Food employees must comply with restrictions or exclusions imposed
21
upon them.
22
A conditional employee is a potential food employee to whom a job offer has been
23
made, conditional on responses to subsequent medical questions or examinations.
Guam Food Code Annex 1 – Public Health Reasons
27
1
A conditional employee becomes a food employee as soon as the employee begins
2
working, even if only on a restricted basis. When a conditional employee reports a
3
listed diagnosis or symptom, the person in charge is responsible for ensuring that
4
the conditional employee is prohibited from becoming a food employee until the
5
criteria for reinstatement of an exclusion are met (as specified under section
6
2-201.13 of the Food Code).
7
employee has met the same criteria for reinstatement that apply to an excluded
8
symptomatic or diagnosed food employee (as specified under section 2-201.13 of
9
the Food Code), the conditional employee may then begin working as a food
When a symptomatic or diagnosed conditional
10
employee.
11
Reporting Symptoms:
12
In order to protect the health of consumers and employees, information concerning
13
the health status of conditional employees and food employees must be disclosed to
14
the person in charge.
15
symptoms experienced by persons suffering from the pathogens identified by CDC
16
as transmissible through food by infected food employees. A food employee
17
suffering from any of the symptoms listed presents an increased risk of transmitting
18
foodborne illness.
The symptoms listed in the Code cover the common
Guam Food Code Annex 1 – Public Health Reasons
28
1
The symptoms of vomiting, diarrhea, or jaundice serve as an indication that an
2
individual may be infected with a fecal-oral route pathogen, and is likely to be
3
excreting high levels of the infectious agent. When a food employee is shedding
4
extremely high numbers of a pathogen through the stool or vomitus, there is greater
5
chance of transmitting the pathogen to food products.
6
Sore throat with fever serves as an indication that the individual may be infected with
7
Streptococcus pyogenes. Streptococcus pyogenes causes a common infection
8
otherwise known as “streptococcal sore throat” or “strep throat.” Streptococcal sore
9
throat can spread from contaminated hands to food, which has been the source of
10
explosive streptococcal sore throat outbreaks. Previous foodborne episodes with
11
streptococcus sore throat have occurred in contaminated milk and egg products.
12
Food products can be contaminated by infected food workers hands or from nasal
13
discharges. Untreated individuals in uncomplicated cases can be communicable for
14
10-21 days, and untreated individuals with purulent discharges may be
15
communicable for weeks or months.
16
Lesions containing pus that may occur on a food employee’s hands, as opposed to
17
such wounds on other parts of the body, represent a direct threat for introducing
18
Staphylococcus aureus into food. Consequently, a double barrier is required to
19
cover hand and wrist lesions. Pustular lesions on the arms are less of a concern
20
when usual food preparation practices are employed and, therefore, a single barrier
21
is allowed. However, if the food preparation practices entail contact of the exposed
22
portion of the arm with food, a barrier equivalent to that required for the hands and
23
wrists would be necessitated. Lesions on other parts of the body need to be
Guam Food Code Annex 1 – Public Health Reasons
29
1
covered; but an impermeable bandage is not considered necessary for food safety
2
purposes. Food employees should be aware that hands and fingers that contact
3
pustular lesions on other parts of the body or with the mucous membrane of the
4
nose also pose a direct threat for introducing Staphylococcus aureus into food.
5
If a food employee has an infected cut and bandages it and puts on a glove, the
6
employee does not have to report the infected cut to the person in charge.
7
However, if the employee does not bandage it, reporting is required.
8
Title I of the Americans with Disabilities Act of 1990 (ADA)
9
Title I of the Americans with Disabilities Act of 1990 (ADA) prohibits medical
10
examinations and inquiries as to the existence, nature, or severity of a disability
11
before extending a conditional offer of employment. In order for the permit holder
12
and the person in charge to be in compliance with this particular aspect of the Code
13
and the ADA, a conditional job offer must be made before making inquiries about the
14
applicant’s health status.
15
The ADA also requires that employers provide reasonable accommodation to
16
qualified applicants and employees with disabilities. A reasonable accommodation
17
is a change in the application process, in the way a job is done, or to other parts of
18
the job that enables a person with a disability to have equal employment
19
opportunities. ADA disabilities are serious, long-term conditions. Most people with
20
diseases resulting from the pathogens listed in the Food Code do not have ADA
21
disabilities because these diseases are usually short-term in duration. In addition,
22
the gastrointestinal symptoms listed in the Food Code usually are not long-term and
23
severe enough, in themselves, to be ADA disabilities. Of course, these symptoms
Guam Food Code Annex 1 – Public Health Reasons
30
1
may be linked to other conditions that may be serious enough to be ADA disabilities,
2
like Crohn’s disease or cancer.
3
A food employer may exclude any employee under the Food Code upon initially
4
learning that the employee has Salmonella Typhi, or has a gastrointestinal symptom
5
listed in the Food Code. The excluded employee may then ask for an ADA
6
reasonable accommodation instead of the exclusion. In response, the employer’s
7
first step should be to ask the employee to establish that the employee is disabled
8
by the disease or symptom (or that the symptom is caused by another ADA
9
disability). If the employee successfully proves that the employee has an ADA
10
disability, then the employer may continue to exclude the employee under the Food
11
Code if:
12

there is no reasonable accommodation at work that would eliminate
13
the risk of transmitting the disease while also allowing the employee to
14
work in a food handling position, or
15

16
17
all reasonable accommodations would pose an undue hardship on the
employer’s business; and

18
there is no vacant position not involving food handling for which the
employee is qualified and to which the employee can be reassigned.
19
Example 1:
20
employer that the employee has been diagnosed with a disease caused by
21
Salmonella Typhi. The employer immediately excludes the employee under the
22
requirements of the Food Code. The employee then establishes that the disease is
23
an ADA disability because it is severe and long-term and the employee requests
A food employee working in the café of a department store informs the
Guam Food Code Annex 1 – Public Health Reasons
31
1
reasonable accommodation instead of an exclusion. The employer determines that
2
no reasonable accommodation would eliminate the risk of transmitting Salmonella
3
Typhi through food and refuses to remove the exclusion. However, there is a vacant
4
clerical position in another part of the store for which the employee is qualified.
5
Unless the employer can establish that reassigning the employee to this position
6
would be an undue hardship, the employer’s failure to make the reassignment
7
instead of continuing the exclusion would be a violation of the ADA.1
8
Example 2:
A food employee has diarrhea and is excluded.
9
establishes
that the diarrhea is caused by Crohn’s disease. This employee also
The employee
10
establishes a serious longstanding history of Crohn’s disease and is an individual
11
with an ADA disability. Crohn’s disease is not a communicable disease and cannot
12
be transmitted through food. No reasonable accommodation is needed to eliminate
13
the risk of transmitting the disease through the food supply, so the Food Code
14
exclusion should be removed. Of course, the Food Code’s provisions on personal
15
cleanliness for hands and arms apply as usual, requiring employees to clean hands
16
and exposed portions of arms after using the toilet room and in other specified
17
circumstances (Subpart 2-301).
18
Somewhat different rules apply to conditional employees. If a conditional employee
19
reports a disease or symptom listed in the Food Code and shows that the disease or
20
symptom makes the conditional employee an individual with an ADA disability, the
21
employer may withdraw the job offer only if:

22
The job involves food handling; and
1
Whether or not the employee in question is an individual with an ADA disability, in those jurisdictions where the
Code is adopted, Food Code exclusions or restrictions must be removed when requirements for removal under
Guam Food Code Annex 1 – Public Health Reasons
32
1

The employer determines that either there is no reasonable
2
accommodation that would eliminate the risk of transmitting the
3
disease through food, or any such accommodation would be an undue
4
hardship to the business.
5
6

There is no need to offer the conditional employee a vacant position
not involving food handling as a reasonable accommodation.
7
It should be noted that the information provided here about the ADA is intended to
8
alert employers to the existence of ADA and related CFR requirements. For a
9
comprehensive understanding of the ADA and its implications, consult the
10
references listed in Annex 2 that relate to this section of the Code or contact the U.S.
11
Equal Employment Opportunity Commission.
12
Opportunity Commission’s How to Comply with the Americans with Disabilities Act:
13
A Guide for Restaurants and Other Food Service Employers, found at
14
http://www.eeoc.gov/facts/restaurant_guide.html
15
http://www.eeoc.gov/facts/restaurant_guide_summary.html for detailed information
16
about the interaction between the FDA Food Code and the ADA.
17
The information required from applicants and food employees is designed to identify
18
employees who may be suffering from a disease that can be transmitted through
19
food. It is the responsibility of the permit holder to convey to applicants and
20
employees the importance of notifying the person in charge of changes in their
21
health status. Once notified, the person in charge can take action to prevent the
22
likelihood of the transmission of foodborne illness. Applicants, to whom a conditional
23
offer of employment is extended, and food employees are required to report their
See the Equal Employment
§ 2-201.13 of the Code are met.
Guam Food Code Annex 1 – Public Health Reasons
33
or
1
specific history of exposure, medical symptoms, and previous illnesses. The
2
symptoms listed may be indicative of a disease that is transmitted through the food
3
supply by infected food employees.
4
As required by the ADA, the CDC published in the Federal Register on October 4,
5
2004, (Volume 69, Number 191) a list of infectious and communicable diseases that
6
are transmitted through food. The CDC updates the list annually.
7
See “List of Infectious and Communicable Diseases which are Transmitted
8
through the Food Supply“ at
9
http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/
10
pdf/04-22260.pdf). The list is divided into two parts: pathogens often transmitted
11
and pathogens occasionally transmitted by infected persons who handle food.
12
The following Lists summarize the CDC list by comparing the common symptoms
13
of each pathogen. Symptoms may include diarrhea, fever, vomiting, jaundice,
14
and sore throat with fever. The CDC has no evidence that the HIV virus is
15
transmissible via food. Therefore, a food employee positive for the HIV virus is
16
not of concern unless suffering secondary illness listed below. The following Lists
17
include all enterohemorrhagic or Shiga toxin-producing E. coli likely to occur in
18
foods in the United States.
19
20
21
22
23
24
25
LIST I.
Pathogens Often Transmitted by Food Contaminated by Infected
Persons Who Handle Food, and Modes of Transmission of Such
Pathogens.
D
F
V
1. Noroviruses
D
F
V
26
2. Hepatitis A virus
-
F
27
3. Salmonella Typhi
-
F
Guam Food Code Annex 1 – Public Health Reasons
34
J
S
-
J
-
-
-
-
1
4. Shigella species
D
F
V
-
-
2
5. Staphylococcus aureus
D
-
V
-
-
3
6.. Streptococcus pyogenes
-
F
-
-
S
4
5
6
7
8
9
10
LIST II.
Pathogens Occasionally Transmitted by Food Contaminated by
Infected Persons Who Handle Food, But Usually Transmitted by
Contamination at the Source or in Food Processing or by Nonfoodborne Routes.
D
F
V
J
S
D
F
V
-
-
-
-
-
-
11
1. Campylobacter jejuni
12
2. Cryptosporidium parvum
13
3. Entamoeba histolytica
D
F
-
-
-
14
4. Enterohemorrhagic Escherichia coli
D
-
-
-
-
15
5. Enterotoxigenic Escherichia coli D
-
V
-
-
16
6. Giardia lamblia
D
-
-
-
-
17
7. Non-typhoidal Salmonella
D
F
V
-
-
18
8. Taenia solium
-
-
-
-
-
19
9. Vibrio cholerae 01
D
-
V
-
-
20
10. Yersinia enterocolitica
D
F
V
-
-
D
21
22
23
KEY: D = Diarrhea
F = Fever
V = Vomiting
S = Sore throat with fever
J = Jaundice
24
The 5 Listed Pathogens:
25
The CDC has designated the 5 organisms listed in the Food Code as having high
26
infectivity via contamination of food by infected food employees. This designation is
27
based on the number of confirmed cases reported that involved food employees
28
infected with one of these organisms and/or the severity of the medical
29
consequences to those who become ill.
Guam Food Code Annex 1 – Public Health Reasons
35
1
The following is taken from information provided in the 18th Edition of Control of
2
Communicable Diseases Manual, the CDC website, and the FDA Bad Bug Book,
3
and is provided as background information on pathogen virulence, infectivity, and
4
common symptoms exhibited with infection of each of the 5 listed pathogens.
5
NOROVIRUS
6
Noroviruses (genus Norovirus, family Caliciviridae) are a group of small (27-40nm),
7
round structured, single-stranded RNA, nonenveloped viruses that cause acute
8
gastroenteritis in humans. Norovirus has also been commonly known as “Norwalk-
9
like virus,” “Small Round-structured Virus,” and “Winter Vomiting Disease.”
10
The CDC estimates that Norovirus is the leading cause of foodborne illness in the
11
United States. Transmission of Norovirus has been shown to occur most commonly
12
through the fecal oral route, with contaminated food identified as a common vehicle
13
of transmission. Exclusion of food employees exhibiting or reporting diarrhea
14
symptoms is an essential intervention in controlling the transmission of Norovirus
15
from infected food employees’ hands to RTE food items. Norovirus also has a high
16
secondary attack rate (> 50%) via person-to-person contact.
17
Norovirus has also been reported to cause infection by airborne transmission when
18
individuals are in close physical proximity to an infected individual vomiting in the
19
facility. Therefore, an infected individual vomiting in a food facility increases the risk
20
of infecting employees and consumers. Foodborne illness outbreaks have occurred
21
from consumers vomiting in the dining room, or employees vomiting on the
22
premises. Removing food employees exhibiting or reporting vomiting symptoms
Guam Food Code Annex 1 – Public Health Reasons
36
1
from the food facility protects consumers and fellow workers from infection with
2
Norovirus.
3
Incubation Period: Generally between 24 and 48 hours (median in outbreaks 33 to
4
36 hours), but cases can occur within 12 hours of exposure.
5
Symptoms and Complications: Acute-onset explosive (or projectile) vomiting,
6
watery non-bloody diarrhea with abdominal cramps, nausea, and occasionally, a low
7
grade fever. Symptoms usually last 24 to 60 hours. Vomiting is more common in
8
children. Recovery is usually complete and there is no evidence of any serious
9
long-term sequelae. Among the young and the elderly, dehydration is a common
10
complication. There is no long-term immunity to Norovirus and individuals may be
11
repeatedly infected throughout their lifetimes. There is no specific therapy for viral
12
gastroenteritis. Symptomatic therapy consists of replacement of fluid loss by the
13
administration of liquids orally, and in rare instances, through parenteral intravenous
14
fluid therapy. Earlier feeding studies conducted on Norovirus have found that as
15
many as 30% of individuals infected with Norovirus are asymptomatic.
16
Infectivity: Noroviruses are highly contagious, and it is thought that an inoculum of
17
as few as 10 viral particles may be sufficient to infect an individual. Although pre-
18
symptomatic shedding may occur, shedding usually begins with onset of symptoms
19
and may continue for 2 weeks after recovery. However, the degree of infectivity of
20
prolonged shedding has not been determined. Norovirus is shed at high levels in
21
the stool: 105 – 107/g or more.
22
SALMONELLA TYPHI
Guam Food Code Annex 1 – Public Health Reasons
37
1
Salmonella enterica subspecies enterica serovar Typhi (commonly S.Typhi) causes
2
a systemic bacterial disease, with humans as the only host. This disease is
3
relatively rare in the United States, with fewer than 500 sporadic cases occurring
4
annually in the U.S. Worldwide, the annual estimated incidence of Typhoid fever is
5
about 17 million cases with approximately 600,000 deaths. Currently, most cases of
6
S. Typhi in industrialized nations are imported into the country from developing
7
countries. Antibiotic-resistant strains have become prevalent in several areas of the
8
world.
9
Incubation period: Depends on inoculum size and on host factors: from 3 days to
10
over 60 days, with a usual range of 8 – 14 days.
11
Symptoms:
12
anorexia, relative bradycardia, splenomegaly, and nonproductive cough in the early
13
stage of the illness, rose spots on the trunk in 25% of white skinned patients and
14
constipation more often than diarrhea in adults. The illness varies from mild illness
15
with low-grade fever to severe clinical disease with abdominal discomfort and
16
multiple complications.
17
Infectivity: The minimal infectious dose is estimated to be less than 1000 bacterial
18
cells. An individual infected with S. Typhi is infectious as long as the bacilli appear
19
in the excreta, usually from the first week throughout the convalescence; variable
20
thereafter. About 10% of untreated typhoid fever patients will discharge bacilli for 3
21
months after onset of symptoms, and 2%-5% become permanent carriers; fewer
22
persons affected with paratyphoid organisms may become permanent gallbladder
23
carriers.
Insidious onset of sustained fever, marked headache, malaise,
Guam Food Code Annex 1 – Public Health Reasons
38
1
ENTEROHEMORRHAGIC OR SHIGA TOXIN-PRODUCING ESCHERICHIA COLI
2
E. coli O157:H7 is the most commonly identified strain of Enterohemorrhagic
3
Escherichia coli (EHEC) or Shiga toxin-producing Escherichia coli (STEC) as a
4
cause of foodborne illness in the United States. E. coli O157:H7 is a zoonotic
5
disease derived from cattle and other ruminants. However, E. coli O157:H7 also
6
readily transmits from person-to-person, so contaminated raw ingredients and ill
7
food employees both can be sources of foodborne disease. Other EHEC or STEC
8
serotypes have been identified as a source of foodborne illness in the United States,
9
however not as frequently as E. coli O157:H7.
The other serogroups most
10
commonly implicated as a cause of foodborne illness in the United States are 026,
11
0111, 0103, 045, and 0121.
12
The Food Code definition of STEC covers all E. coli identified in clinical laboratories
13
that produce Shiga toxins. Nearly 200 O:H combinations of E. coli have been
14
shown to produce Shiga toxins. The Food Code definition includes all STEC,
15
including those that have not been specifically implicated in human disease such as
16
hemorrhagic colitis (i.e., bloody diarrhea) or hemolytic uremic syndrome (HUS). A
17
subset of STEC that has the capacity to both produce Shiga toxin and cause
18
“attaching and effacing” lesions in the intestine is classified as “enterohemorrhagic”
19
(EHEC). EHEC E. coli cause hemorrhagic colitis, meaning bleeding enterically or
20
bleeding from the intestine. Infections with EHEC may be asymptomatic but are
21
classically associated with bloody diarrhea (hemorrhagic colitis) and hemolytic
22
uremic syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP). Virtually all
23
human isolates of E. coli O157:H7 serotypes are EHEC.
Guam Food Code Annex 1 – Public Health Reasons
39
1
Incubation period: From 2-10 days, with a median of 3-4 days.
2
Symptoms: The illness is characterized by severe cramping (abdominal pain) and
3
diarrhea with a range from mild and nonbloody to stools that are virtually all blood.
4
Occasionally vomiting occurs. Some individuals exhibit watery diarrhea only. Lack
5
of fever in most patients can help to differentiate this infection from other enteric
6
pathogens. About 8% of individuals with E. coli O157:H7 diarrhea progress to HUS.
7
This rate varies for other serotypes of Enterohemorrhagic E. coli.
8
Infectivity: The infectious dose is for example E. coli O157:H7 can be as low as 10
9
bacterial cells. Children under 5 years old are most frequently diagnosed with
10
infection and are at greatest risk of developing HUS. The elderly also experience a
11
greater risk of complications. The duration of excretion of Enterohemorrhagic E.
12
coli in the stool is typically 1 week or less in adults, but can be up to 3 weeks in one-
13
third of infected children.
14
SHIGELLA SPP.
15
Causes an acute bacterial disease, known as shigellosis, and primarily occurs in
16
humans, but also occurs in other primates such as monkeys and chimpanzees. An
17
estimated 300,000 cases of shigellosis occur annually in the U.S. Shigella spp.
18
consist of 4 species or serogroups, including S. flexneri, S. boydii, S. sonnei, and
19
S. dysenteriae; which all differ in geographical distribution and pathogenicity.
20
Shigella spp. are highly infectious and highly virulent.
21
overcrowding conditions, where personal hygiene is poor, including in institutions,
22
such as prisons, mental hospitals, day care centers, and refugee camps, and also
23
among men who have sex with men. Water and RTE foods contaminated by feces,
Guam Food Code Annex 1 – Public Health Reasons
40
Outbreaks occur in
1
frequently from food workers’ hands, are common causes of disease transmission.
2
Multidrug-resistant Shigella (including S. dysenteriae 1) have appeared worldwide.
3
Concern over increasing antimicrobial resistance has led to reduced use of
4
antimicrobial therapy in treating shigellosis.
5
Incubation period: Usually 1 – 3 days, but ranges from 12 to 96 hours, and up to 1
6
week for S. dysenteriae 1.
7
Symptoms and Complications: Abdominal pain, diarrhea, fever, nausea, and
8
sometimes vomiting, tenesmus, toxaemia, and cramps. The stools typically contain
9
blood, pus, or mucus resulting from mucosal ulcerations. The illness is usually self-
10
limited, with an average duration of 4-7 days. Infections are also associated with
11
rectal bleeding, drastic dehydration, and convulsions in young children. The fatality
12
rate for Shigella dysenteriae 1 may be as high as 20% among hospitalized cases.
13
Other complications can also occur, such as Reiter’s disease, reactive arthritis,
14
intestinal perforation, and hemolytic uremic syndrome.
15
Infectivity: The infectious dose for humans is low, with as few as 10 bacterial cells
16
depending on age and condition of the host. Infectivity occurs during acute infection
17
and until the infectious agent is no longer present in feces, usually within 4 weeks
18
after illness. Asymptomatic carriers may transmit infection; rarely, the carrier state
19
may persist for months or longer.
20
HEPATITIS A VIRUS
21
Hepatitis A virus (HAV) is a 27-nanometer picornavirus (positive strand RNA, non-
22
enveloped virus). The hepatitis A virus has been classified as a member of the
23
family Picornaviridae. The exact pathogenesis of HAV infection is not understood,
Guam Food Code Annex 1 – Public Health Reasons
41
1
but the virus appears to invade from the intestinal tract and is subsequently
2
transported to the liver. The hepatocytes are the site of viral replication and the
3
virus is thought to be shed via the bile.
4
HAV is most commonly spread by the fecal-oral route through person-to-person
5
contact. Risk factors for reported cases of hepatitis A include personal or sexual
6
contact with another case, illegal drug use, homosexual male sex contact, and travel
7
to an endemic country. Common source outbreaks also can occur through ingestion
8
of water or food that has fecal contamination. However, the source of infection is
9
not identified for approximately 50% of reported cases.
10
HAV infection is endemic in developing countries, and less common in industrialized
11
countries with good environmental sanitation and hygienic practices.
12
developing world, nearly all HAV infections occur in childhood and are asymptomatic
13
or cause a mild illness. As a result, hepatitis A (symptomatic infection with jaundice)
14
is rarely seen in the developing world. More than 90% of adults born in many
15
developing countries are seropositive.
16
Children play an important role in the transmission of HAV and serve as a source of
17
infection for others, because most children have asymptomatic infections or mild,
18
unrecognized HAV infections. In the United States, the disease is most common
19
among school-aged children and young adults. After correction for under-reporting
20
and undiagnosed infections, an estimated 61,000 HAV infections (includes cases of
21
hepatitis A as well as asymptomatic infections) occurred in 2003.
22
HAV Immunization: Immune globulin can be used to provide passive pre-exposure
23
immunoprophylaxis against hepatitis A. Protection is immediately conferred to an
Guam Food Code Annex 1 – Public Health Reasons
42
In the
1
exposed individual following administration of IG, and immunity is provided for 3-5
2
months following inoculation. IG is effective in preventing HAV infection when given
3
as post-exposure immunoprophylaxis, if given within 14 days of exposure. When a
4
food service worker with hepatitis A is identified, IG is often given to co-workers.
5
Active immunoprophylaxis using hepatitis A vaccine (a formalin-inactivated,
6
attenuated strain of HAV) has been shown to provid immunity in > 95% of those
7
immunized, with minimal adverse reactions. Hepatitis A vaccination of food workers
8
has been advocated, but has not been shown to be cost-effective and generally is
9
not recommended in the United States, although it may be appropriate in some
10
communities.
11
Incubation period: Average 28 – 30 days (range 15 – 50 days).
12
Symptoms and Complications: Illness usually begins with symptoms such as
13
nausea/vomiting, diarrhea, abdominal pain, fever, headache, and/or fatigue.
14
Jaundice, dark urine or light colored stools might be present at onset, or follow
15
illness symptoms within a few days. HAV infection of older children and adults is
16
more likely to cause clinical illness with jaundice (i.e., hepatitis A); onset of illness is
17
usually
18
jaundiced. Jaundice generally occurs 5-7 days after the onset of gastrointestinal
19
symptoms. For asymptomatic infections, evidence of hepatitis may be detectable
20
only through laboratory tests of liver infections such as alanine aminotransferase
21
(ALT) tests. The disease varies in severity from a mild illness to a fulminant
22
hepatitis, ranging from 1-2 weeks to several months in duration. In up to 10-15% of
23
the reported cases, prolonged, relapsing hepatitis for up to 6 months occurs. The
abrupt.
In young adults, 76-97% have symptoms and 40-70% are
Guam Food Code Annex 1 – Public Health Reasons
43
1
degree of severity often increases with age; however, most cases result in complete
2
recovery, without sequelae or recurrence. The reported case fatality rate is 0.1% -
3
0.3% and can reach 1.8% for adults over 50 years old.
4
Diagnosis: Diagnosis of HAV infection requires specific serological testing for IgM
5
anti-HAV. IgM anti-HAV becomes undetectectable within 6 months of illness onset
6
for most persons; however, some persons can remain IgM anti-HAV positive for
7
years after acute infection. Total anti-HAV (the only other licensed serologic test)
8
can be detected during acute infection but remains positive after recovery and for
9
the remainder of the person’s life.
10
Infectivity: Evidence indicates maximum infectivity during the latter half of the
11
incubation period, continuing for a few days after onset of jaundice. Most cases are
12
probably noninfectious after the first week of jaundice. Chronic shedding of HAV in
13
feces has not been reported. HAV is shed at peak levels in the feces, one to two
14
weeks before onset of symptoms, and shedding diminishes rapidly after liver
15
dysfunction or symptoms appear. Liver dysfunction or symptoms occur at the same
16
time circulating antibodies to HAV first appear. Immunity after infection probably
17
lasts for life; immunity after vaccination is estimated to last for at least 20 years.
18
Reporting History of Exposure:
19
The reporting requirements for history of exposure are designed to identify
20
employees who may be incubating an infection due to Norovirus, Shigella spp.,
21
E. coli O157:H7 or other EHEC/STEC, typhoid fever, or HAV.
22
Which employees who report exposure are restricted?
Guam Food Code Annex 1 – Public Health Reasons
44
1

2
3
4
Employees who work in a food establishment serving a highly
susceptible population (HSP) facility.
What constitutes exposure?

Consuming a food that caused illness in another consumer due to
5
infection with Norovirus, Shigella spp., E. coli O157:H7 or other
6
EHEC/STEC, typhoid fever, or HAV.
7

8
9
Attending an event or working in a setting where there is a known
disease outbreak.

10
Close contact with a household member who is ill and is diagnosed
with a listed pathogen.
11
Why are other guidelines provided, in addition to restriction for employees serving
12
an HSP who report exposure to hepatitis A virus?
13

Employees who have had a hepatitis A illness in the past are most
14
likely protected from infection by life-time immunity to hepatitis A
15
infection.
16

17
18
Immunity developed through immunization or IgG inoculation prevents
hepatitis A infection in exposed employees.

Our standard definition of HSP doesn’t apply very well to HAV.
19
Children under 6 years old who become infected with HAV are
20
generally asymptomatic, and while a higher proportion of susceptible
21
elderly
22
institutionalized elderly are protected from HAV by prior infection.
23
who
become
infected
have
serious
What is the period of restriction?
Guam Food Code Annex 1 – Public Health Reasons
45
illness,
most
1

The period of restriction begins with the most recent time of foodborne
2
or household member exposure and lasts for the usual incubation
3
period of the pathogen as defined in the Control of Communicable
4
Diseases Manual. This is the time that the employee is most likely to
5
begin shedding the pathogen.
6
o
For Norovirus, 48 hours after the most recent exposure
7
o
For Shigella spp., 3 days after the most recent exposure
8
o
For E. coli O157:H7 or other EHEC/STEC, 3 days after the
9
most recent exposure
10
o
11
For typhoid fever (S. Typhi), 14 days after the most recent
exposure
12
o
For HAV, 30 days after the most recent exposure
13
What is the period of restriction when exposed to a diagnosed, ill household
14
member?
15

While the household member is symptomatic with an infection due to
16
Norovirus, Shigella spp., E coli O157:H7 or other EHEC/STEC,
17
typhoid fever (S. Typhi) or HAV;
18

Plus during the usual incubation period of the pathogen of concern:
19
o
For Norovirus, symptomatic period plus 48 hours
20
o
For Shigella spp., symptomatic period plus 3 days
21
o
For E. coli O157:H7 or other EHEC/STEC, symptomatic period
22
23
plus 3 days
o
For typhoid fever (S. Typhi), symptomatic period plus 14 days
Guam Food Code Annex 1 – Public Health Reasons
46
1
2
3
o
For HAV, onset of jaundice plus 30 days
What is the appropriate response to a report of exposure to other food employees?

Employees who report a history of exposure but who do not work in a HSP
4
facility should be reminded of the requirements for reporting illness,
5
avoidance of bare hand contact with RTE foods, and proper hand washing
6
and personal hygiene.
Guam Food Code Annex 1 – Public Health Reasons
47
1
2-201.12
Exclusions and Restrictions.2
2
Refer to public health reasons for § 2-201.11 for actions to take with conditional
3
employees.
4
It is necessary to exclude food employees symptomatic with diarrhea, vomiting, or
5
jaundice, or suffering from a disease likely to be transmitted through contamination
6
of food, because of the increased risk that the food being prepared will be
7
contaminated such as with a pathogenic microorganism. However, if the food
8
employee is suffering from vomiting or diarrhea symptoms, and the condition is from
9
a non-infectious condition, Crohn’s disease or an illness during early stages of a
10
pregnancy, the risk of transmitting a pathogenic microorganism is minimal. In this
11
case, the food employee may remain working in a full capacity if they can
12
substantiate that the symptom is from a noninfectious condition. The food employee
13
can substantiate this through providing to the person in charge medical
14
documentation or other documentation proving that the symptom is from a
15
noninfectious condition.
16
Because of the high infectivity (ability to invade and multiply) and/or virulence (ability
17
to produce severe disease), of typhoid fever (Salmonella Typhi) and hepatitis A
18
virus, a food employee diagnosed with an active case of illness caused by either of
19
these two pathogens, whether asymptomatic or symptomatic, must be excluded
20
from food establishments. The exclusion is based on the high infectivity, and/or the
2
In order to comply with Title I of the Americans with Disabilities Act, an exclusion must also be removed if the
employee is entitled to a reasonable accommodation that would eliminate the risk of transmitting the disease.
Reasonable accommodation may include reassignment to another position in which the individual would not work
around food. The steps an employer must take when an excluded employee requests reasonable accommodation
are briefly described in Annex 3, § 2-201.11. However, it is not possible to explain all relevant aspects of the ADA
within this Annex. When faced with an apparent conflict between ADA and the Food Code’s exclusion and restriction
requirements, employers should contact the U.S. Equal Employment Opportunity Commission.
Guam Food Code Annex 1 – Public Health Reasons
48
1
severe medical consequences to individuals infected with these organisms. A food
2
employee diagnosed with an active case of illness caused by Norovirus, Shigella
3
spp., or E. coli O157:H7 or other EHEC/STEC, is excluded if exhibiting symptoms of
4
vomiting and diarrhea, and then allowed to work as the level of risk of pathogen
5
transmission decreases (See section 2-201.12, Tables #1b, #2 and #3).
6
The degree of risk for a food employee or conditional employee who is diagnosed
7
with an infection but asymptomatic with regard to symptoms, to transmit a foodborne
8
pathogen decreases with the resolution of symptoms. This risk decreases even
9
further for those employees that are diagnosed with a listed pathogen, but never
10
developed symptoms. The decrease in risk is taken under consideration when
11
excluding and restricting diagnosed food employees and results in a slight difference
12
in the way food employees diagnosed with Norovirus, but asymptomatic with respect
13
to gastrointestinal symptoms are handled (See section 2-201.12, Table #2).
Guam Food Code Annex 1 – Public Health Reasons
49
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
2-201.11 / 2-201.12 Decision Tree 1. When to Exclude or Restrict a Food
Employee Who Reports a Symptom and When to Exclude a Food Employee
Who Reports a Diagnosis with Symptoms Under the Food Code
Is the Food Employee reporting listed symptoms?
Yes
Symptoms of
V, J, D
Symptoms of infected
wound or cut
Exclude per
Table 1a.
Symptoms of
ST with F
HSP
Restrict per
Table 1a.
Exclude per
Table 1a.
Gen. Pop.
(Non-HSP)
Restrict per
Table 1a.
If reporting a diagnosis with hepatitis A virus, or typhoid fever
Exclude per
Table 1b.
If reporting a diagnosis with Shigellosis, Norovirus, or EHEC/STEC
and symptoms of V or D
Exclude per
Table 1b.
Key:
Listed Symptoms for Reporting: (V) Vomiting; (J) Jaundice; (D) Diarrhea; (ST with F) Sore Throat
with Fever; (HSP) Highly Susceptible Population; (Gen. Pop.) General Population
Guam Food Code Annex 1 – Public Health Reasons
50
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
2-201.11 / 2-201.12 Decision Tree 2. When to Exclude or Restrict a Food Employee
Who is Asymptomatic and Reports a Listed Diagnosis and When to Restrict a Food
Employee Who Reports a Listed Exposure Under the Food Code
Is the Food Employee reporting listed
symptoms?
No
Is the food employee reporting
diagnosis with infection due to . . .
Norovirus?
Shigella spp.
or EHEC?
S. Typhi or
Hepatitis A
virus?
No
Yes
Yes
Yes
No
No
Exclude
per
Table 2
or 3.
HSP
Exclude per
Table 2 or 3.
Gen. Pop.
(Non-HSP)
HSP
Restrict per
Table 2 or 3.
Exclude per
Table 2 or 3.
Gen. Pop.
(Non- HSP)
Restrict per
Table 2 or 3.
Is the food employee reporting exposure to Norovirus, E. coli O157:H7
or other EHEC, HAV, Shigella, or Typhoid fever (S. Typhi)?
Yes
HSP
Restrict per
Table 4.
No
Gen. Pop.
(Non-HSP)
No Action Necessary
Educate on symptoms; reinforce requirement to report listed
symptoms; ensure compliance with good hygienic practices,
handwashing, and no bare hand contact with ready-to-eat food.
Key:
(HSP) Highly Susceptible Population; (Gen. Pop.) General Population
Guam Food Code Annex 1 – Public Health Reasons
51
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
2-201.12 Table 1a: Summary of Requirements for Symptomatic Food Employees
Food employees and conditional employees shall report symptoms
immediately to the person in charge
The person in charge shall prohibit a conditional employee that reports a listed symptom from becoming a food
employee until meeting the criteria listed in section 2-201.13 of the Food Code, for reinstatement of a
symptomatic food employee.
EXCLUSION/ OR RESTRICTION
Symptom
Vomiting
Diarrhea
Jaundice
Sore Throat
with Fever
Infected
wound or
pustular
boil
Facilities
Serving a HSP
EXCLUDE
2-201.12(A)(1)
Removing symptomatic food
employees from exclusion or
restriction
RA Approval
Needed to
Return to
Work?
No if not
diagnosed
Facilities not
serving a HSP
EXCLUDE
When the excluded food employee has
2-201.12(A)(1) been asymptomatic for at least 24 hours
or provides medical documentation
-201.13(A)(1).
Exceptions: If diagnosed with
Norovirus, Shigella spp., E. coli
O157:H7 or other EHEC, HAV, or
typhoid fever (S. Typhi) (see Tables 1b
& 2).
EXCLUDE
EXCLUDE
When the excluded food employee has
No if not
2-201.12(A)(1) 2-201.12(A)(1) been asymptomatic for at least 24 hours
diagnosed
or provides medical documentation
2-201.13(A).
Exceptions: If Diagnosed with Norovirus,
E. coli O157:H7 or other EHEC, HAV, or
S. Typhi (see Tables 1b & 2).
EXCLUDE
EXCLUDE
When approval is obtained from the RA
Yes
2-201.12(B)(1) 2-201.12(B)(1) 2-201.13 (B), and:
if the onset
if the onset
• Food employee has been
occurred within occurred within
jaundiced for more than 7
the last 7 days the last 7 days
calendar days 2-201.13(B)(1), or
• Provides medical documentation
2-201.13(B)(3).
EXCLUDE
RESTRICT
When food employee provides written
No
2-201.12(G)(1) 2-201.12(G)(2) medical documentation 201.13(G) (1)-(3).
RESTRICT
RESTRICT
When the infected wound or boil is
No
2-201.12(H)
2-201.12(H)
properly covered 2-201.13(H)(1)-(3).
Key for Tables 1, 2, 3, and 4:
RA = Regulatory Authority
EHEC = Enterohemorrhagic, or Shiga toxin-producing Escherichia coli
HAV = Hepatitis A virus
HSP = Highly Susceptible Population
Guam Food Code Annex 1 – Public Health Reasons
52
1
2
3
4
5
2-201.12 Table 1b: Summary of Requirements for Diagnosed, Symptomatic Food
Employees
6
7
The person in charge shall notify the RA when a food employee is jaundiced or
reports a listed diagnosis
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
Food employees and conditional employees shall report a listed
diagnosis with symptoms immediately to the person in charge
The person in charge shall prohibit a conditional employee that reports a listed diagnosis with
symptoms from becoming a food employee until meeting the criteria listed in section 2-201.13 of the
Food Code, for reinstatement of a diagnosed, symptomatic food employee.
Diagnosis
EXCLUSION
Facilities Serving HSP
or not Serving HSP
Hepatitis A
virus
EXCLUDE if
within 14 days
of any symptom,
or within 7 days
of jaundice
2-201.12(B)(2)
Typhoid Fever
(S. Typhi)
EXCLUDE
2-201.12(C)
E. coli
O157:H7 or
other EHEC/
STEC
EXCLUDE
Based on
vomiting or
diarrhea
symptoms,
under
2-201.12(A)(2)
Removing diagnosed, symptomatic
food employees from exclusion
When approval is obtained from the
RA 2-201.13(B), and:
• The food employee has been jaundiced
for more than 7 calendar days 2-201.13
(B)(1), or
• The anicteric food employee has had
symptoms or more than 14 days
2-201.13(B)(2), or
• The food employee provides medical
documentation 2-201.13(B)(3) (also see
Table 2).
When approval is obtained from the
RA 2-201.13(C)(1), and:
• Food employee provides medical
documentation, that states the food
employee is free of a S. Typhi infection
2-201.13(C)(2) (also see Table 2).
RA Approval
Needed to
Return to
Work?
Yes
Yes
1. Serving Non-HSP facility: 2-201.13(A)(4)(a):
Yes to
Shall only work on a restricted basis 24
return to
hours after symptoms resolve and remains
HSP or to
restricted until meeting the requirements
return
listed below:
unrestricted;
2. Serving HSP facility: 2-201.13(A)(4)(b):
Not required
Remains excluded until meeting the
to work on a
requirements listed below:
restricted
• Approval is obtained from RA 2-201.13(F), basis in a
and
non-HSP
• Medically cleared 2-201.13(F)(1), or
facility
• More than 7 calendar days have passed
since the food employee became
asymptomatic 2-201.13(F)(2)
(also see Table 2).
(continued on next page)
Guam Food Code Annex 1 – Public Health Reasons
53
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
2-201.12 Table 1b: Summary of Requirements for Diagnosed, Symptomatic Food
Employees (continued)
Diagnosis
EXCLUSION
Facilities Serving HSP
or not Serving HS
Norovirus
EXCLUDE
Based on
vomiting or
diarrhea
symptoms,
under
2-201.12(A)(2)
Shigella spp.
EXCLUDE
Based on
vomiting or
diarrhea
symptoms,
under
2-201.12(A)(2)
Removing diagnosed, symptomatic
food employees from exclusion
RA Approval
Needed to
Return to
Work?
1. Serving Non-HSP facility: 2-201.13(A)(2)(a): Yes to
Shall only work on a restricted basis 24
return to
hours after symptoms resolve and remains
HSP or to
restricted until meeting the requirements
return
listed below:
unrestricted;
2. Serving HSP facility: 2-201.13(A)(2)(b):
Not required
Remains excluded until meeting the
to work on a
requirements listed below:
restricted
• Approval is obtained from RA 2-201.13(D), basis in a
and
non-HSP
• Medically cleared 2-201.13(D)(1), or
facility
• More than 48 hours have passed
since the food employee became
asymptomatic 2-201.13(D)(2)
(also see Table 2).
1. Serving Non-HSP facility: 2-201.13(A)(3)(a):
Shall only work on a restricted basis 24
hours after symptoms resolve, and remains
restricted until meeting the requirements
listed below:
2. Serving HSP facility: 2-201.13(A)(3)(b):
Remains excluded until meeting the
requirements listed below:
• Approval is obtained from RA 2-201.13(E),
and
• Medically cleared 2-201.13(E)(1), or
• More than 7 calendar days have passed
since the food employee became
asymptomatic 2-201.13(E)(2)
(also see Table 2).
Guam Food Code Annex 1 – Public Health Reasons
54
Yes to
return to
HSP or to
return
unrestricted;
Not required
to work on a
restricted
basis in a
non-HSP
facility
1
2
3
4
5
2-201.12 Table 2: Summary of Requirements for Diagnosed Food Employees with
Resolved Symptoms
6
7
The person in charge shall notify the RA when a food employee reports a listed
diagnosis
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
Food employees and conditional employees shall report a
listed diagnosis immediately to the person in charge
The person in charge shall prohibit a conditional employee that reports a listed diagnosis from
becoming a food employee until meeting the criteria listed in section 2-201.13 of the Food Code, for
reinstatement of a diagnosed food employee.
Pathogen
Diagnosis
Facilities
Serving HSP
Typhoid
fever
(S. Typhi)
including
previous
illness
with S.Typhi
(see 2-201.11
(A)(3)
Shigella
spp.
Facilities Not
Serving
HSP
EXCLUDE
EXCLUDE
2-201.12(C)
2-201.12(C)
EXCLUDE
RESTRICT
2-201.12(E)(1)
2-201.12(E)(2)
Removing Diagnosed Food
Employees with Resolved
Symptoms from Exclusion
or Restriction
When approval is obtained from the RA
2-201.13(C)(1), and:
• Food employee provides
medical documentation, that
states the food employee is free
of a S. Typhi infection
2-201.13)(C)(2) (also see
Table 1b).
RA Approval
Return to
Work?
Yes
1. Serving Non-HSP facility:
Yes to
2-201.13(A)(3)(a): Shall only work
return to
on a restricted basis 24 hours after
HSP or to
symptoms resolve, and remains
return
restricted until meeting the
unrestricted;
requirements listed below:
Not required
2. Serving HSP facility:
to work on a
2-201.13(A)(3)(b): Remains
restricted
excluded until meeting the
basis in a
requirements listed below:
non-HSP
• Approval is obtained from the
facility
RA 2-201.13(E), and:
• Medically cleared
2-201.13(E)(1), or
• More than 7 calendar days
have passed since the food
employee became
asymptomatic 2-201.13(E)(3)(a)
(also see Table 1b).
(continued on next page)
Guam Food Code Annex 1 – Public Health Reasons
55
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
2-201.12 Table 2: Summary of Requirements for Diagnosed Food Employees with
Resolved Symptoms (continued)
Pathogen
Diagnosis
Norovirus
E. coli
O157:H7
or other
EHEC/
STEC
Facilities
Serving HSP
Facilities Not
Serving
HSP
Removing Diagnosed Food
Employees with Resolved
Symptoms from Exclusion
or Restriction
RA Approval
Return to
Work?
1. Serving Non-HSP facility:
2-201.13(A)(2)(a): Shall only work
on a restricted basis 24 hours after
symptoms resolve, and remains
restricted until meeting the
requirements listed below:
2. Serving HSP facility:
2-201.13(A)(2)(b): Remains
excluded until meeting the
requirements listed below:
• Approval is obtained from the
RA 2-201.13(D), and:
• Medically cleared
2-201.13(D)(1), or
passed since the food
employee became
asymptomatic 2-201.13(D)(2)
(also see Table 1b).
Yes to
return to
HSP or to
return
unrestricted;
Not required
to work on a
restricted
basis in a
non-HSP
facility
EXCLUDE
RESTRICT
1. Serving Non-HSP facility:
2-201.12(F)(1) 2-201.12(F)(2) 2-201.13(A)(4)(a): Shall only work
Yes to
return to
HSP or to
return
unrestricted;
Not required
to work on a
restricted
basis in a
non-HSP
facility
EXCLUDE
RESTRICT
2-201.12(D)(1)
2-201.12(D)(2)
on a restricted basis 24 hours after
symptoms resolve, and remains
restricted until meeting the
requirements listed below:
2. Serving HSP facility:
2-201.13(A)(4)(b): Remains
excluded until meeting the
requirements listed below:
• Approval is obtained from the
RA 2-201.13(F), and:
• Medically cleared
2-201.13(F)(1), or
• More than 7 calendar days
have passed since the food
employee became
asymptomatic 2-201.13(F)(2).
(continued on next page)
Guam Food Code Annex 1 – Public Health Reasons
56
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
2-201.12 Table 2: Summary of Requirements for Diagnosed Food Employees with
Resolved Symptoms (continued)
Pathogen
Diagnosis
Facilities
Serving HSP
Hepatitis A EXCLUDE if
virus
within 14 days
of any
symptom, or
within 7 days
of jaundice
2-201.12(B)(2)
Facilities Not
Serving
HSP
Removing Diagnosed Food
Employees with Resolved
Symptoms from Exclusion
or Restriction
EXCLUDE if
When approval is obtained from the RA
within 14 days of 2-201.13(B), and:
any symptom, or
• The food employee has been
within 7 days of
jaundiced for more than 7
jaundice
calendar days 2-201.13(B)(1), or
2-201.12(B)(2)
• The anicteric food employee
has had symptoms for more
than 14 days 2-201.13(B)(2), or
• The food employee provides
medical documentation
2-201.13(B)(3) (see also
Table 1b).
Guam Food Code Annex 1 – Public Health Reasons
57
RA Approval
Return to
Work?
Yes
1
2
3
4
5
2-201.12 Table 3: Summary of Requirements for Diagnosed Food Employees Who
Never Develop Gastrointestinal Symptoms
6
7
The person in charge shall notify the RA when a food employee reports a listed
diagnosis
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
Food employees and conditional employees shall report a listed
diagnosis immediately to the person in charge
The person in charge shall prohibit a conditional employee that reports a listed diagnosis from
becoming a food employee until meeting the criteria listed in section 2-201.13 of the Food Code, for
reinstatement of a diagnosed food employee
Pathogen
Diagnosis
Facilities
Serving HSP
Facilities Not
Serving
HSP
Removing Diagnosed Food
Employees Who Never Develop
Gastrointestinal Symptoms
from Exclusion or Restriction
Typhoid
EXCLUDE
EXCLUDE
fever
2-201.12(C)
2-201.12(C)
(S. Typhi)
including
previous
illness
with S.Typhi
(see 2-201.11
(A)(3))
Shigella
EXCLUDE
RESTRICT
spp.
2-201.12(E)(1)2-201.12(E)(2)
When approval is obtained from the RA
2-201.13(C)(1), and:
Norovirus
Remains excluded or restricted until
approval is obtained from the
RA 2-201.13(D), and
EXCLUDE
RESTRICT
2-201.12(D)(1)
2-201.12(D)(2)
RA Approval
Return to
Work?
Yes
Food employee provides medical
documentation, specifying that the food
employee is free of a S. Typhi infection
2-201.13(C)(2).
Remains excluded or restricted until
approval is obtained from the RA, and:
Yes to return
to HSP or to
return
• Medically cleared 2-201.13(E)(1), or unrestricted;
• More than 7 calendar days have
Not required
passed since the food employee was to work on a
last diagnosed 2-201.13(E)(3).
restricted
basis in a
non-HSP
facility
Yes to return
to HSP or to
return
unrestricted;
• Medically cleared 2-201.13(D)(1), or Not required
• More than 48 hours have passed
to work on a
since the food employee was
restricted
last diagnosed 2-201.13(D)(3).
basis in a
non-HSP
facility
(continued on next page)
Guam Food Code Annex 1 – Public Health Reasons
58
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
2-201.12 Table 3: Summary of Requirements for Diagnosed Food Employees Who
Never Develop Gastrointestinal Symptoms (continued)
Pathogen
Diagnosis
Facilities
Serving HSP
Facilities Not
Serving
HSP
E. coli
O157:H7
or other
EHEC/
STEC
EXCLUDE
RESTRICT
Hepatitis
A virus
EXCLUDE
2-201.12(F)(1)
2-201.12(F)(2)
Removing Diagnosed Food
Employees Who Never Develop
Gastrointestinal Symptoms
from Exclusion or Restriction
Remains excluded or restricted until
approval is obtained from the
RA 2-201.13(F), and
• Medically cleared 2-201.13(F)(1), or
• More than 7 calendar days have
passed since the food employee was
last diagnosed 2-201.13(F)(3).
EXCLUDE
2-201.12(B)(3)
2-201.12(B)(3)
When approval is obtained from the RA
2-201.13(B), and
•
•
The anicteric food employee has
had symptoms for more than 14
days 2-201.13(B)(2), or
The food employee provides
medical documentation
2-201.13(B)(3).
Key for Tables 1, 2, 3, and 4:
RA = Regulatory Authority
EHEC = Enterohemorrhagic, or Shiga toxin-producing Escherichia coli
HAV = Hepatitis A virus
HSP = Highly Susceptible Population
Guam Food Code Annex 1 – Public Health Reasons
59
RA Approval
Return to
Work?
Yes to return
to HSP or to
return
unrestricted;
Not required
to work on a
restricted
basis in a
non-HSP
facility
Yes
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
2-201.12 Table 4: History of Exposure, and Absent Symptoms or Diagnosis
Food employees and conditional employees shall report a listed exposure to the person in charge
The person in charge shall prohibit a conditional employee who reports a listed exposure from
becoming a food employee in a facility serving a HSP until meeting the criteria listed in section
2-201.13 of the Food Code, for reinstatement of an exposed food employee
The person in charge shall reinforce and ensure compliance with good hygienic practices, symptom reporting
requirements, proper handwashing and no BHC with RTE foods for all food employees that report a listed
exposure
Pathogen
Diagnosis
Typhoid
Fever
(S. Typhi)
Facilities
Serving HSP
RESTRICT
2-201.12(I)
Facilities Not Serving
HSP
Educate food employee
on symptoms to watch
for and ensure
compliance with GHP,
handwashing and no
BHC with RTE foods.
When Can the Restricted
RA Approval
Food Employee Return Work?
needed
2-201.13(I)(3)
No
When 14 calendar days have passed
since the last exposure, or more than
14 days has passed since the food
employee’s household contact
became asymptomatic.
Shigella
spp.
RESTRICT
2-201.12(I)
Norovirus
RESTRICT
2-201.12(I)
Educate food employee
on symptoms to watch
for and ensure
compliance with GHP,
handwashing and no
BHC with RTE foods.
Educate food employee
on symptoms to watch
for and ensure
compliance with GHP,
handwashing and no
bare hand contact with
RTE foods.
Educate food employee
on symptoms to watch
for and ensure
compliance with GHP,
handwashing and no
bare hand contact with
RTE foods.
Educate food employee
on symptoms to watch
for and ensure
compliance with GHP,
handwashing and no
bare hand contact with
RTE foods.
2-201.13(I)(2)
When more than 3 calendar days
have passed since the last exposure,
or more than 3 days have passed
since the food employee’s household
contact became asymptomatic.
2-201.13(I)(1)
When more than 48 hours have
passed since the last exposure, or
more than 48 hours has passed since
the food employee’s household
contact became asymptomatic
No
No
2-201.13(I)(2)
No
When more than 3 calendar days
have passed since the last exposure,
or more than 3 calendar days has
passed since the food employee’s
household contact became
asymptomatic.
Hepatitis A RESTRICT
2-201.13(I)(4)
No
virus
2-201.12(I)
When any of the following conditions
is met:
* The food employee is immune to
HAV infection because of a prior
illness from HAV, vaccination against
HAV, or IgG administration; or
* More than 30 calendar days have
passed since the last exposure; or
since the food employee’s household
contact became jaundiced; or
* The food employee does not use an
alternative procedure that allows BHC
with RTE food until at least 30 days
after the potential exposure, and the
employee receives additional training
Key for Table 4: GHP = Good Hygienic Practices; RTE = Ready-to-Eat foods; BHC = Bare Hand Contact
E. coli
RESTRICT
O157:H7 or 2-201.12(I)
other EHEC/
STEC
Guam Food Code Annex 1 – Public Health Reasons
60
1
2-201.12
Exclusion and Restrictions (continued)3
2
Restrictions and exclusions vary according to the population served because highly
3
susceptible populations have increased vulnerability to foodborne illness. For
4
example, foodborne illness in a healthy individual may be manifested by mild flu-like
5
symptoms. The same foodborne illness may have serious medical consequences in
6
immunocompromised individuals. This point is reinforced by statistics pertaining to
7
deaths associated with foodborne illness caused by Salmonella Enteritidis. Over
8
70% of the deaths in outbreaks attributed to this organism occurred among
9
individuals who for one reason or another were immunocompromised. This is why
10
the restrictions and exclusions listed in the Code are especially stringent for food
11
employees serving highly susceptible populations.
12
Periodic testing of food employees for the presence of diseases transmissible
13
through food is not cost effective or reliable. Therefore, restriction and exclusion
14
provisions are triggered by the active gastrointestinal symptoms, followed by
15
diagnosis and history of exposure.
16
The history of exposure that must be reported applies only to the 5 organisms listed.
17
Upon being notified of the history of exposure, the person in charge should
18
immediately:
19
1.
Discuss the traditional modes of transmission of fecal-oral route pathogens.
3
In order to comply with Title I of the Americans with Disabilities Act, an exclusion must also be removed if the
employee is entitled to a reasonable accommodation that would eliminate the risk of transmitting the disease.
Reasonable accommodation may include reassignment to another position in which the individual would not work
around food. The steps an employer must take when an excluded employee requests reasonable accommodation
are briefly described in Annex 3, § 2-201.11. However, it is not possible to explain all relevant aspects of the ADA
within this Annex. When faced with an apparent conflict between the ADA and the Food Code’s exclusion and
restriction requirements, employers should contact the U.S. Equal Employment Opportunity Commission.
Guam Food Code Annex 1 – Public Health Reasons
61
1
2.
Advise the food employee to observe good hygienic practices both at home
2
and at work. This includes a discussion of proper handwashing, as described
3
in the Code, after going to the bathroom, changing diapers, or handling stool-
4
soiled material.
5
3.
6
7
Review the symptoms listed in the Code that require immediate exclusion
from the food establishment.
4.
Remind food employees of their responsibility as specified in the Code to
8
inform the person in charge immediately upon the onset of any of the
9
symptoms listed in the Code.
10
5.
Ensure that the food employee stops work immediately if any of the
11
symptoms described in the Code develop and reports to the person in
12
charge.
13
A restricted food employee may work in an area of the food establishment that
14
houses packaged food, wrapped single-service or single-use articles, or soiled food
15
equipment or utensils. Examples of activities that a restricted person might do
16
include working at the cash register, seating patrons, bussing tables, stocking
17
canned or other packaged foods, or working in a non-food cleaning or maintenance
18
capacity consistent with the criteria in the definition of the term “restricted.” A food
19
employee who is restricted from working in one food establishment may not work in
20
an unrestricted capacity in another food establishment, but could work unrestricted
21
in another retail store that is not a food establishment. A restricted food employee
22
may enter a food establishment as a consumer.
Guam Food Code Annex 1 – Public Health Reasons
62
1
An excluded individual may not work as a food employee on the premises of any
2
food establishment.
3
2-201.13
Removal of Exclusions and Restrictions.4
4
Food employees diagnosed with Norovirus, hepatitis A virus, Shigella spp., E. coli
5
O157:H7 or other EHEC, and symptomatic with diarrhea, vomiting, or jaundice, are
6
excluded under subparagraph 2-201.12 (A)(2) or 2-201.12(B)(2). owever, these
7
symptomatic, diagnosed food employees differ from symptomatic, undiagnosed food
8
employees in the requirements that must be met before returning to work in a full
9
capacity after symptoms resolve.
10
The person in charge may allow undiagnosed food employees who are initially
11
symptomatic and whose symptoms have resolved to return to work in a full capacity
12
24 hours after symptoms resolve.
13
However, diagnosis with a listed pathogen invokes additional requirements before
14
the person in charge may allow diagnosed food employees to return to work in full
15
capacity.
16
Asymptomatic food employees diagnosed with Norovirus, Shigella spp., E. coli
17
O157:H7 or other EHEC may not return to work in a full capacity for at least 24
18
hours after symptoms resolve. The person in charge shall only allow these food
19
employees to work on a restricted basis 24 hours after symptoms resolve and they
20
shall only allow this if not in a food establishment that serves a highly susceptible
4
In order to comply with Title I of the Americans with Disabilities Act, an exclusion must also be removed if the
employee is entitled to a reasonable accommodation that would eliminate the risk of transmitting the disease.
Reasonable accommodation may include reassignment to another position in which the individual would not work
around food. The steps an employer must take when an excluded employee requests reasonable accommodation
are briefly described in Annex 3, § 2-201.11. However, it is not possible to explain all relevant aspects of the ADA
within this Annex. When faced with an apparent conflict between the ADA and the Food Code’s exclusion and
restriction requirements, employers should contact the U.S. Equal Employment Opportunity Commission.
Guam Food Code Annex 1 – Public Health Reasons
63
1
population.
These restricted food employees remain restricted until they are
2
medically cleared or otherwise meet the criteria for removal from restriction as
3
specified under subparagraphs 2-201.13(D) (1)-(2); 2-201.13(E)(1)-(2); or 2-
4
201.13(F)(1)-(2).
5
In a food establishment that serves a highly susceptible population, food employees
6
who are diagnosed with Norovirus, Shigella spp., E. coli O157:H7 or other EHEC
7
and initially symptomatic with vomiting or diarrhea, shall not work on a restricted
8
basis after being asymptomatic for at least 24 hours. These food employees must
9
remain excluded until they are medically cleared or otherwise meet the criteria for
10
removal from exclusion from a highly susceptible population under subparagraph 2-
11
201.13(D) (1)-(2), 2-201.13(E)(1)-(2), or 2-201.13 (F)(1)-(2).
12
Food employees diagnosed with hepatitis A virus are always excluded if diagnosed
13
within 14 days of exhibiting any illness symptom, until at least 7 days after the onset
14
of jaundice, or until medically cleared as specified under subparagraphs 2-
15
201.13(B)(1)-(4).
16
Food employees diagnosed with hepatitis A virus are always excluded if diagnosed
17
within 14 days of exhibiting any illness symptom, until at least 7 days after the onset
18
of jaundice, or until medically cleared as specified under subparagraph
19
201.13(B)(1)-(3). A food employee with an anicteric infection with the hepatitis A
20
virus has a mild form of hepatitis A without jaundice. Food employees diagnosed
21
with an anicteric infection with the hepatitis A virus are excluded if they are within 14
22
days of any symptoms. Anicteric, diagnosed food employees shall be removed from
Guam Food Code Annex 1 – Public Health Reasons
64
2-
1
exclusion if more than 14 days have passed since they became symptomatic, or if
2
medically cleared. Asymptomatic food employees diagnosed with an active infection
3
with the hepatitis A virus are also excluded until medically cleared.
4
Hands and Arms
5
The hands are particularly important in transmitting foodborne pathogens. Food
6
employees with dirty hands and/or fingernails may contaminate the food being
7
prepared. Therefore, any activity which may contaminate the hands must be
8
followed by thorough handwashing in accordance with the procedures outlined in the
9
Code.
2-301.11
Clean Condition.*
10
Even seemingly healthy employees may serve as reservoirs for pathogenic
11
microorganisms that are transmissible through food. Staphylococci, for example,
12
can be found on the skin and in the mouth, throat, and nose of many employees.
13
The hands of employees can be contaminated by touching their nose or other body
14
parts.
15
2-301.12
Cleaning Procedure.*
16
Handwashing is a critical factor in reducing fecal-oral pathogens that can be
17
transmitted from hands to RTE food as well as other pathogens that can be
18
transmitted from environmental sources. Many employees fail to wash their hands
19
as often as necessary and even those who do may use flawed techniques.
20
In the case of a food worker with one hand or a hand-like prosthesis, the Equal
21
Employment Opportunity Commission has agreed that this requirement for thorough
22
handwashing can be met through reasonable accommodation in accordance with
23
the Americans with Disabilities Act. Devices are available which can be attached to
Guam Food Code Annex 1 – Public Health Reasons
65
1
a lavatory to enable the food worker with one hand to adequately generate the
2
necessary friction to achieve the intent of this requirement.
3
The greatest concentration of microbes exists around and under the fingernails of
4
the hands. The area under the fingernails, known as the “subungal space,” has by
5
far the largest concentration of microbes on the hand and this is also the most
6
difficult area of the hand to decontaminate. Fingernail brushes, if used properly,
7
have been found to be effective tools in decontaminating this area of the hand.
8
Proper use of single-use fingernail brushes, or designated individual fingernail
9
brushes for each employee, during the handwashing procedure can achieve up to a
10
5-log reduction in microorganisms on the hands.
11
There are two different types of microbes on the hands, transient and resident
12
microbes. Transient microbes consist of contaminating pathogens which are loosely
13
attached to the skin surface and do not survive or multiply. A moderate number of
14
these organisms can be removed with adequate handwashing. Resident microbes
15
consist of a relatively stable population that survive and multiply on the skin and
16
they are not easily washed off the hands. Resident microbes on the hands are
17
usually not a concern for potential contamination in food service.
18
All aspects of proper handwashing are important in reducing microbial transients
19
on the hands. However, friction and water have been found to play the most
20
important role. This is why the amount of time spent scrubbing the hands is critical
21
in proper handwashing. It takes more than just the use of soap and running water to
22
remove the transient pathogens that may be present. It is the abrasive action
23
obtained by vigorously rubbing the surfaces being cleaned that loosens the
Guam Food Code Annex 1 – Public Health Reasons
66
1
transient microorganisms on the hands.
2
Research has shown a minimum 10-15 second scrub is necessary to remove
3
transient pathogens from the hands and when an antimicrobial soap is used, a
4
minimum of 15 seconds is required. Soap is important for the surfactant effect in
5
removing soil from the hands and a warm water temperature is important in
6
achieving the maximum surfactant effect of the soap.
7
Every stage in handwashing is equally important and has an additive effect in
8
transient microbial reduction. Therefore, effective handwashing must include
9
scrubbing, rinsing, and drying the hands. When done properly, each stage of
10
handwashing further decreases the transient microbial load on the hands. It is
11
equally important to avoid recontaminating hands by avoiding direct hand contact
12
with heavily contaminated environmental sources, such as manually operated
13
handwashing sink faucets, paper towel dispensers, and rest room door handles
14
after the handwashing procedure. This can be accomplished by obtaining a paper
15
towel from its dispenser before the handwashing procedure, then, after
16
handwashing, using the paper towel to operate the hand sink faucet handles and
17
restroom door handles.
18
Handwashing done properly can result in a 2-3 log reduction in transient bacteria
19
and a 2-log reduction in transient viruses and protozoa. With heavy contamination
20
of
21
contaminated with bodily wastes and infected bodily fluids) handwashing may be
22
ineffective in completely decontaminating the hands.
23
intervention such as a barrier between hands and ready-to-eat food is necessary.
transient
microbial pathogens, (i.e., > 104 microbes, as found on hands
Guam Food Code Annex 1 – Public Health Reasons
67
Therefore,
a further
1
2-301.13
Special Handwash Procedures.*
2
This section is reserved.
3
In earlier editions of the Code, FDA's model contained a provision for a Special
4
Procedure in certain situations. Pursuant to a 1996 Conference for Food Protection
5
(CFP) Recommendation, the text of this Code provision is removed and the section
6
is reserved. It is FDA's intent to further research the matter and to submit the
7
findings to the CFP for reconsideration of the matter.
8
2-301.14
When to Wash.*
9
The hands may become contaminated when the food employee engages in specific
10
activities. The increased risk of contamination requires handwashing immediately
11
after the activities listed. The specific examples listed in this Code section are not
12
intended to be all inclusive. Employees must wash their hands after any activity
13
which may result in contamination of the hands.
14
2-301.15
Where to Wash.
15
Effective handwashing is essential for minimizing the likelihood of the hands
16
becoming a vehicle of cross contamination. It is important that handwashing be
17
done only at a properly equipped handwashing facility in order to help ensure that
18
food employees effectively clean their hands.
19
conveniently located, always accessible for handwashing, maintained so they
20
provide proper water temperatures and pressure, and equipped with suitable hand
21
cleansers, nail brushes, and disposable towels and waste containers, or hand
22
dryers. It is inappropriate to wash hands in a food preparation sink since this may
23
result in avoidable contamination of the sink and the food prepared therein. Service
Handwashing sinks are to be
Guam Food Code Annex 1 – Public Health Reasons
68
1
sinks may not be used for food employee handwashing since this practice may
2
introduce additional hand contaminants because these sinks may be used for the
3
disposal of mop water, toxic chemicals, and a variety of other liquid wastes. Such
4
wastes may contain pathogens from cleaning the floors of food preparation areas
5
and toilet rooms and discharges from ill persons.
6
2-301.16
Hand Antiseptics.
7
In the 2005 Food Code, the use of the term “hand sanitizer” was replaced by the
8
term “hand antiseptic” to eliminate confusion with the term “sanitizer,” a defined
9
term in the Food Code, and to more closely reflect the terminology used in the FDA
10
Tentative Final Monograph for Health-Care Antiseptic Drug Products for OTC
11
Human Use, Federal Register: June 17, 1994.
12
The term “sanitizer” is typically used to describe control of bacterial contamination of
13
inert objects or articles, or equipment and utensils, and other cleaned food-contact
14
surfaces. The Food Code definition of “sanitizer” requires a minimum microbial
15
reduction of 5 logs, which is equal to a 99.999% reduction. The FDA bases the 5-
16
log reduction on the AOAC International’s “Official Methods of Analysis 2003,” which
17
requires a minimum 5-log reduction in microorganisms to achieve “sanitization.”
18
Sanitizers used to disinfect food-contact equipment and utensils can easily achieve
19
the 5-log reduction of microorganisms and often far exceed this minimum
20
requirement. However, removing microorganisms from human skin is a totally
21
different process and sterilization of human skin is nearly impossible to achieve
22
without damaging the skin. Many antimicrobial hand agents typically achieve a
23
much smaller reduction in microorganisms than the 5-log reduction required for
Guam Food Code Annex 1 – Public Health Reasons
69
1
“sanitization.” Therefore, the effect achieved from using antimicrobial hand agents
2
is not consistent with the definition of “sanitization” in the Food Code.
3
The word “antiseptic” is a Greek term, meaning “against putrefaction,” and
4
eventually evolved into a second definition, meaning, “a substance used to destroy
5
pathogenic microorganisms.” The term “antiseptic” is often used to describe agents
6
used on skin to prevent infection of the skin.
7
“Antiseptic” is defined under section 201 (o) of the Federal Food, Drug, and
8
Cosmetic Act (the act) (21 U.S.C. 321 (o), as: “The representation of a drug, in its
9
labeling, as an antiseptic shall be considered to be a representation of a germicide,
10
except in the case of a drug purporting to be, or represented as, an antiseptic for
11
inhibitory use as a wet dressing, ointment, dusting powder, or such other use as
12
involves prolonged contact with the body.”
13
Section 333.403 of the FDA Tentative Final Monograph for Health-Care Antiseptic
14
Drug Products for OTC Human Use, Federal Register: June 17, 1994, defines a
15
“health-care antiseptic” as an antiseptic-containing drug product applied topically to
16
the skin to help prevent infection or to help prevent cross contamination. An
17
“antiseptic handwash” or “health-care personnel handwash drug product” is
18
defined in Section 333.403 of the Monograph as an antiseptic containing preparation
19
designed for frequent use; it reduces the number of transient microorganisms on
20
intact skin to an initial baseline level after adequate washing, rinsing, and drying; it is
21
a broad spectrum, and persistent antiseptic containing preparation that significantly
22
reduces the number of microorganisms on intact skin.
Guam Food Code Annex 1 – Public Health Reasons
70
1
Replacing the term “hand sanitizer” with the term “hand antiseptic” allows the use of
2
a more scientifically appropriate term that is used to describe reduction of
3
microorganisms on the skin and will improve clarification and regulation of these
4
products.
5
The provisions of § 2-301.16 are intended to ensure that an antimicrobial
6
product applied to the hands is 1) safe and effective when applied to human skin,
7
and 2) a safe food additive when applied to bare hands that will come into direct
8
contact with food. Because of the need to protect workers and to ensure safe food,
9
hand antiseptics must comply with both the human drug and the food safety
10
provisions of the law. The prohibition against bare hand contact contained in 3-
11
301.11(B) applies only to an exposed ready-to-eat food.
12
As a Drug Product
13
There are two means by which a hand antiseptic is considered to be safe and
14
effective when applied to human skin:
15
1. A hand antiseptic may be approved by FDA under a new drug application
16
based on data showing safety and effectiveness and may be listed in the
17
publication Approved Drug Products with Therapeutic Equivalence
18
Evaluations.
19
Administration, Center for Drug Evaluation and Research, Office of
20
Pharmaceutical Science, Office of Generic Drugs. Also known as the
21
“Orange Book,” this document provides “product-specific” listings rather than
22
listings by compound. It is published annually with monthly supplements and
23
is available at http://www.fda.gov/cder/ob/default.htm. However, as of the
This document is maintained by the Food and
Guam Food Code Annex 1 – Public Health Reasons
71
Drug
1
end of 1998, no hand antiseptics are listed in this publication since no new
2
drug applications have been submitted and approved for these products.
3
2. A hand antiseptic active ingredient may be identified by FDA in the
4
monograph for OTC (over-the-counter) Health-Care Antiseptic Drug Products
5
under the antiseptic handwash category. Since hand anti septic products
6
are intended and labeled for topical antimicrobial use by food employees in
7
the prevention of disease in humans, these products are “drugs” under the
8
Federal Food, Drug, and Cosmetic Act § 201(g). As drugs, hand antiseptics
9
and dips must be manufactured by an establishment that is duly registered
10
with the FDA as a drug manufacturer; their manufacturing, processing,
11
packaging, and labeling must be performed in conformance with drug Good
12
Manufacturing Practices (GMP's); and the product must be listed with FDA as
13
a drug product.
14
Products having the same formulation, labeling, and dosage form as those that
15
existed in the marketplace on or before December 4, 1975, for hand antiseptic use
16
by food handlers, are being evaluated under the Over-the-Counter (OTC) Drug
17
Review by FDA’s Center for Drug Evaluation and Research. However, as of May
18
2005, a final OTC drug monograph for these products has not been finalized.
19
Therefore, FDA has not made a final determination that any of these products are
20
generally recognized as safe and effective (GRAS/E).
21
GRAS/E antimicrobial ingredients for hand sanitizer use by food handlers will be
22
identified in a future final monograph issued under the OTC Drug Review.
23
Information about whether a specific product is covered by the proposed monograph
Guam Food Code Annex 1 – Public Health Reasons
72
1
may be obtained from the tentative final monograph (TFM) for “Health Care
2
Antiseptic Drug Products for OTC Human Use; Proposed Rule.” This TFM, which
3
was published in the Federal Register of June 17, 1994 (59 FR 31402), describes
4
the inclusion of hand sanitizers in this Review on page 31440 under Comment 28 of
5
Part II. Information about whether a specific product is included in this proposed
6
monograph may also be available from the manufacturer.
7
Questions regarding acceptability of a hand antiseptic with respect to OTC
8
compliance may be directed to the Division of New Drugs and Labeling Compliance
9
(HFD-310), Office of Compliance, Center for Drug Evaluation and Research, Food
10
and Drug Administration, 11919 Rockville Pike, Rockville, MD 20852. Specific
11
product label/promotional information and
12
determining a product’s regulatory status.
13
As a Food Additive
14
To be subject to regulation under the food additive provisions of the Federal Food,
15
Drug, and Cosmetic Act, the substances in a hand antiseptic must reasonably be
16
expected to become a component of food based upon the product’s intended use.
17
Where the substances in a hand antiseptic are reasonably expected to become a
18
component of food based upon the product’s intended use, circumstances under
19
which those substances may be legally used include the following:
20
1.
the formulation are required for
The intended use of a substance may be exempted from regulation
Guam Food Code Annex 1 – Public Health Reasons
73
1
as a food additive under 21 CFR 170.39. Threshold of regulation for
2
substances used in food-contact articles. A review by FDA’s Center for Food
3
Safety and Applied Nutrition is required in order to determine whether such
4
an exemption can be granted.
5
2.
A substance may be regulated for the intended use as a food additive under
6
21 CFR 174 – Indirect Food Additives – General, and be listed along with
7
conditions of safe use in 21 CFR 178 – Indirect Food Additives: Adjuvants,
8
Production Aids, and Sanitizers.
9
3.
The intended use of a substance, including substances that contact food
10
such as those in hand antiseptics, may be “generally recognized as safe
11
(GRAS)” within the meaning of the FFDCA. A partial listing of substances
12
with food uses that are generally recognized as safe may be found in CFR
13
Parts 182, 184, and 186. These lists are not exhaustive because the FFDCA
14
allows for independent GRAS determinations.
15
For the use of a substance to be GRAS within the meaning of the FFDCA,
16
there must be publicly available data that demonstrate that the substance is
17
safe for its intended use. There also must be a basis to conclude that there
18
is a consensus among qualified experts that these publicly available data
19
establish safety. If the use of a substance in food is GRAS, it is not subject
20
to premarket review by FDA. While there is no legal requirement to notify
21
FDA of an independent GRAS determination, a number of firms have chosen
22
to do so with the expectation of receiving a response letter from FDA (see
23
FDA’s Inventory of GRAS Notices at http://www.cfsan.fda.gov/~rdb/opa-
Guam Food Code Annex 1 – Public Health Reasons
74
1
gras.html. Although such a letter does not affirm the independent GRAS
2
determination, it is an opportunity for the firm to receive comment from FDA
3
regarding the materials supporting its determination.
4
4.
A substance may be the subject of a Food Contact Substance Notification
5
that became effective in accordance with the FFDCA Section 409 (h).
6
Substances that are the subject of an effective food-contact substance
7
notification are listed, along with conditions of safe use, in the FDA Inventory
8
of Effective Premarket Notifications for Food Contact Substances. This list
9
is available on-line at http://www.cfsan.fda.gov/~dms/opa-fcn.html. A food-
10
contact substance that is the subject of an effective notification submitted
11
under FFDCA 409(h) does not include similar or identical substances
12
manufactured or prepared by any person other than the manufacturer
13
identified in that notification.
14
The Division of Food Contact Substance Notifications does not certify or provide
15
approvals for specific products. However, if the intended use of a substance in
16
contact with food meets the requirements of 21 CFR 170.39 Threshold of regulation
17
for substances used in food-contact articles, FDA may provide a letter to a firm
18
stating that the intended use of this product is exempt from regulation as a food
19
additive. However, the product must be the subject of a new drug application or
20
under FDA’s OTC Drug Review to be legally marketed.
21
Questions regarding the regulatory status of substances in hand antiseptics as food
22
additives may be directed to the Division of Food Contact Substance Notifications,
23
HFS-275, 5100 Paint Branch Parkway, College Park, MD 20740. It may be helpful
Guam Food Code Annex 1 – Public Health Reasons
75
1
or necessary to provide label/promotional information when inquiring about a
2
specific substance.
3
Fingernails
4
The requirement for fingernails to be trimmed, filed, and maintained is designed to
5
address both the cleanability of areas beneath the fingernails and the possibility that
6
fingernails or pieces of the fingernails may end up in the food due to breakage.
7
Failure to remove fecal material from beneath the fingernails after defecation can be
8
a major source of pathogenic organisms. Ragged fingernails present cleanability
9
concerns and may harbor pathogenic organisms.
2-302.11
Maintenance.
10
Jewelry
11
Items of jewelry such as rings, bracelets, and watches may collect soil and the
12
construction of the jewelry may hinder routine cleaning. As a result, the jewelry may
13
act as a reservoir of pathogenic organisms transmissible through food.
14
The term “jewelry” generally refers to the ornaments worn for personal adornment
15
and medical alert bracelets do not fit this definition. However, the wearing of such
16
bracelets carries the same potential for transmitting disease-causing organisms to
17
food. If a food worker wears a medical alert or medical information bracelet, the
18
conflict between this need and the Food Code’s requirements can be resolved
19
through reasonable accommodation in accordance with the Americans with
20
Disabilities Act. The person in charge should discuss the Food Code requirement
21
with the employee and together they can work out an acceptable alternative to a
22
bracelet. For example, the medical alert information could be worn in the form of a
23
necklace or anklet to provide the necessary medical information without posing a
2-303.11
Prohibition.
Guam Food Code Annex 1 – Public Health Reasons
76
1
risk to food. Alternatives to medical alert bracelets are available through a number
2
of different companies (e.g., an internet search using the term “medical alert jewelry”
3
leads to numerous suppliers).
4
An additional hazard associated with jewelry is the possibility that pieces of the item
5
or the whole item itself may fall into the food being prepared. Hard foreign objects in
6
food may cause medical problems for consumers, such as chipped and/or broken
7
teeth and internal cuts and lesions.
8
Outer Clothing
9
Dirty clothing may harbor diseases that are transmissible through food. Food
10
employees who inadvertently touch their dirty clothing may contaminate their hands.
11
This could result in contamination of the food being prepared. Food may also be
12
contaminated through direct contact with dirty clothing. In addition, employees
13
wearing dirty clothes send a negative message to consumers about the level of
14
sanitation in the establishment.
15
Food
16
Contamination
17
Prevention
2-304.11
2-401.11
Clean Condition.
Eating, Drinking, or Using Tobacco.*
Guam Food Code Annex 1 – Public Health Reasons
77
1
Proper hygienic practices must be followed by food employees in performing
2
assigned duties to ensure the safety of the food, prevent the introduction of foreign
3
objects into the food, and minimize the possibility of transmitting disease through
4
food. Smoking or eating by employees in food preparation areas is prohibited
5
because of the potential that the hands, food, and food-contact surfaces may
6
become contaminated. Insanitary personal practices such as scratching the head,
7
placing the fingers in or about the mouth or nose, and indiscriminate and uncovered
8
sneezing or coughing may result in food contamination. Poor hygienic practices by
9
employees may also adversely affect consumer confidence in the establishment.
10
Food preparation areas such as hot grills may have elevated temperatures and the
11
excessive heat in these areas may present a medical risk to the workers as a result
12
of dehydration. Consequently, in these areas food employees are allowed to drink
13
from closed containers that are carefully handled.
14
2-401.12
Discharges from the Eyes, Nose, and Mouth.*
15
Discharges from the eyes, nose, or mouth through persistent sneezing or coughing
16
by food employees can directly contaminate exposed food, equipment, utensils,
17
linens, and single-service and single-use articles. When these poor hygienic
18
practices cannot be controlled, the employee must be assigned to duties that
19
minimize the potential for contaminating food and surrounding surfaces and objects.
20
Hair Restraints
2-402.11
Effectiveness.
Guam Food Code Annex 1 – Public Health Reasons
78
1
Consumers are particularly sensitive to food contaminated by hair. Hair can be both
2
a direct and indirect vehicle of contamination. Food employees may contaminate
3
their hands when they touch their hair. A hair restraint keeps dislodged hair from
4
ending up in the food and may deter employees from touching their hair.
5
Animals
6
Dogs and other animals, like humans, may harbor pathogens that are transmissible
7
through food.
8
prohibited because of the risk of contamination of food employee hands and
9
clothing.
2-403.11
Handling Prohibition.*
Handling or caring for animals that may be legally present is
10
Chapter 3 Food
11
12
Condition
13
Sources
14
3-101.11
Safe, Unadulterated, and Honestly
Presented.*
3-201.11
Compliance with Food Law.*
15
Refer to the public health reason for § 3-401.11.
16
Source
17
18
A primary line of defense in ensuring that food meets the requirements of
§ 3-101.11 is to obtain food from approved sources, the implications of which are
19
discussed below. However, it is also critical to monitor food products to ensure that,
20
after harvesting and processing, they do not fall victim to conditions that endanger
21
their safety, make them adulterated, or compromise their honest presentation. The
22
regulatory community, industry, and consumers should exercise vigilance in
23
controlling the conditions to which foods are subjected and be alert to signs of
24
abuse. FDA considers food in hermetically sealed containers that are swelled or
Guam Food Code Annex 1 – Public Health Reasons
79
1
leaking to be adulterated and actionable under the Federal Food, Drug, and
2
Cosmetic Act. Depending on the circumstances, rusted and pitted or dented cans
3
may also present a serious potential hazard.
4
Food, at all stages of production, is susceptible to contamination. The source of
5
food is important because pathogenic microorganisms may be present in the
6
breeding stock of farm animals, in feeds, in the farm environment, in waters used for
7
raising and freezing aquatic foods, and in soils and fertilizers in which plant crops
8
are grown. Chemical contaminants that may be present in field soils, fertilizers,
9
irrigation water, and fishing waters can be incorporated into food plants and
10
animals.
11
Sources of molluscan shellfish are a particular concern because shellfish are
12
frequently consumed raw or in an undercooked state and thus receive neither heat
13
treatment nor any other process that would destroy or inactivate microbial
14
pathogens. For safety, these foods must be accompanied by certification that
15
documents that they have been harvested from waters that meet the water quality
16
standards contained in the National Shellfish Sanitation Program Guide for the
17
Control of Molluscan Shellfish.
18
processing, packaging, and shipping have been conducted under sanitary
19
conditions.
20
Food should be purchased from commercial supplies under regulatory control.
21
Home kitchens, with their varieties of food and open entry to humans and pet
22
animals, are frequently implicated in the microbial contamination of food. Because
23
commercial items seldom are eaten right away, the home kitchen's limited capacity
Certification also provides confidence that
Guam Food Code Annex 1 – Public Health Reasons
80
1
for maintaining food at proper temperatures may result in considerable microbial
2
growth and toxin production by microorganisms introduced through the diverse
3
sources of contamination. Controlled processing is required for the safe preparation
4
of food entering commerce.
5
Labeling – General
6
Sources of packaged food must be labeled in accordance with law. Proper labeling
7
of foods allows consumers to make informed decisions about what they eat. Many
8
consumers, as a result of an existing medical condition, may be sensitive to specific
9
foods or food ingredients.
This sensitivity may result in dangerous medical
10
consequences should certain foods or ingredients be unknowingly consumed. In
11
addition, consumers have a basic right to be protected from misbranding and fraud.
12
Except for certain species of large tuna and raw molluscan shellfish, if fish are
13
intended for raw consumption, they must be properly frozen before they are served.
14
If this process is done off-premises, purchase specifications ensuring that proper
15
freezing techniques are used to destroy parasites must be provided. Labeling
16
should accompany the product to advise as to whether the product was frozen
17
properly. This is necessary because fish from natural bodies of water may carry
18
parasitic worms that can infect and injure consumers who eat such raw fish dishes
19
as sushi, ceviche, green (lightly marinated) herring, and cold-smoked salmon. The
20
worms are often deeply imbedded inside fish muscle. Thorough freezing kills these
21
worms if the fish are subjected to a low enough temperature for a long enough time.
22
Labeling for Fish
Guam Food Code Annex 1 – Public Health Reasons
81
1
Except for certain species of large tuna and raw molluscan shellfish, if fish are
2
intended for raw consumption, they must be properly frozen before they are
3
served. If this process is done off-premises, purchase specifications ensuring that
4
proper freezing techniques are used to destroy parasites must be provided.
5
Labeling or other information should accompany the product to advise as to whether
6
the product was frozen properly. This is necessary because fish from natural
7
bodies of water may carry parasitic worms that can infect and injure consumers who
8
eat such raw fish dishes as sushi, ceviche, green (lightly marinated) herring, and
9
cold-smoked salmon. The worms are often deeply imbedded inside fish muscle.
10
Thorough freezing kills these worms if the fish are subjected to a low enough
11
temperature for a long enough time.
12
Labeling for Juice
13
On July 8, 1998, FDA announced in the Federal Register a final rule that revised
14
its food labeling regulations to require a warning statement on fruit and vegetable
15
juice products that have not been processed to prevent, reduce, or eliminate
16
pathogenic microorganisms that may be present. FDA took this action to inform
17
consumers, particularly those at greatest risk, of the hazard posed by such juice
18
products. FDA expects that providing this information to consumers will allow them
19
to make informed decisions on whether to purchase and consume such juice
20
products, thereby reducing the incidence of foodborne illnesses and deaths caused
21
by the consumption of these juices.
22
On July 18, 2001, FDA announced a final rule designed to improve the safety of
23
fruit and vegetable juice and juice products. Under the rule, juice processors must
Guam Food Code Annex 1 – Public Health Reasons
82
1
use Hazard Analysis and Critical Control Point (HACCP) principles for juice
2
processing. Processors making shelf-stable juices or concentrates that use a single
3
thermal processing step are exempt from the microbial hazard requirements of the
4
HACCP regulation. Retail establishments where packaged juice is made and only
5
sold directly to consumers (such as juice bars) are not required to comply with this
6
regulation.
7
Rather, the Food Code requires fresh fruit or vegetable juices that are packaged at
8
retail (untreated juices or beverages containing untreated juices that are offered to
9
consumers as prepackaged foods) to be processed under HACCP with a 5 log
10
reduction in pathogens of concern OR bear the warning statement as specified in 21
11
CFR Section 101.17(g). That statement is: “WARNING: This product has not been
12
pasteurized and, therefore, may contain harmful bacteria that can cause serious
13
illness in children, the elderly, and persons with weakened immune systems.” Refer
14
to Chapter 1 for the definition of juice. It is important to note that the definition of
15
“juice” includes puréed fruits and vegetables, which are commonly prepared for
16
service to highly susceptible populations.
17
Food establishments that serve a highly susceptible population (HSP) cannot serve
18
prepackaged juice that bears the warning label and they must serve only
19
pasteurized juice. For juice only, this population includes children who are age 9 or
20
less and receive food in a school, day care setting, or similar facility that provides
21
custodial care.
22
Unpackaged juice (glasses of juice prepared at a juice bar, for example) does not
23
require the 5 log reduction nor a warning statement or other consumer advisory
Guam Food Code Annex 1 – Public Health Reasons
83
1
(juice is not an animal food and therefore not covered by section 3-603.11) when
2
prepared and served at retail. Usually the juice is served by the glass or in small
3
batches compared to a commercial juice processor. The risk of using “drops” and
4
damaged fruits or vegetables is much less at retail because of buyer specs that
5
provide higher quality produce, meaning that fruits for juicing are less likely to be of
6
a lower quality or damaged.
7
Additional information is available in the document, “Guidance for Industry. Warning
8
and Notice Statement: Labeling of Juice Products, Small Entity Compliance Guide”
9
which can be found on the FDA website http://www.cfsan.fda.gov/~dms/juicguid.html
10
or obtained from the FDA Office of Nutritional Products Labeling and Dietary
11
Supplements.
12
Labeling for Meat and Poultry
13
Retail food establishments that process and package meat or poultry in a form that
14
is not ready-to-eat, are obligated by Federal regulation to label the product with safe
15
food handling instructions. The intent of this requirement is to ensure that all
16
consumers are alerted to the fact that such products may contain bacteria and that
17
food safety hinges upon their thoroughly cooking the product, regardless of where
18
they obtain the products. That is, the labeling would exist if they obtain their meat
19
and poultry at an establishment that handles only prepackaged and prelabeled
20
products or if they obtain their meat or poultry at an operation such as a
21
supermarket with a meat processing operation or from a small neighborhood
22
butcher.
23
Labeling Guidance for Irradiated Raw Meat and Meat Products
Guam Food Code Annex 1 – Public Health Reasons
84
1
In December 1999, the U.S. Department of Agriculture, Food Safety and Inspection
2
Service (USDA/FSIS) issued a final regulation to permit the use of ionizig radiation
3
to reduce foodborne pathogens, including Escherichia coli O157:H7, and extend
4
the shelf life of raw refrigerated and frozen meat and meat products (Irradiation of
5
Meat Food Products 64 Federal Register 72150, December 23, 1999).
6
The final regulations are published in Title 9 of the Code of Federal Regulations (9
7
CFR 424.21 Use of food ingredients and sources of radiation) and provide that raw
8
refrigerated products may receive a maximum absorbed dose of no more than 4.5
9
kGy, and that frozen products receive no more than 7.0 kGy, in accordance with the
10
FDA restrictions provided for in Title 21 of the Code of Federal Regulations (21 CFR
11
179.26(a) Ionizing radiation for the treatment of food, (a) Energy sources). The
12
regulations further require that all irradiated meat and meat products bear labeling
13
that reflects that the product was irradiated, or that the product contains an
14
irradiated meat or poultry product. This labeling requirement is applicable even at
15
retail facilities where irradiated coarse ground beef might be finely ground for retail
16
sale, or in cases where irradiated product is combined with other non-irradiated
17
meat or poultry product for retail sale.
18
In cases where the entire package of product is irradiated, the labeling must include
19
both a statement and the international symbol, called the radura. Additionally, the
20
product name must include the word “irradiated,” or the labeling must bear a
21
disclosure statement such as, “treated with radiation” or “treated by irradiation.” If
22
either statement is used, the logo must be placed in conjunction with the statement.
23
If an irradiated meat or meat product is used to formulate a multi-ingredient product
Guam Food Code Annex 1 – Public Health Reasons
85
1
with other non-irradiated components, the irradiated meat ingredient must be
2
identified as such in the ingredients statement, but the logo is not required. For
3
example, the ingredients statement for a Chicken and Beef Sausage product that
4
contains irradiated beef would be, Ingredients: chicken, irradiated beef, seasonings
5
(salt, pepper, spice), and the logo would not be required to be present.
6
All labels for products produced at federally inspected establishments bearing
7
statements about irradiation must be submitted to USDA/FSIS for evaluation and
8
approval prior to use.
9
Optional labeling statements about the purpose of the irradiation process may be
10
included on the labeling of irradiated products provided they are not false or
11
misleading and have been evaluated first by USDA/FSIS. If such statements
12
indicate a specific benefit from irradiation, such as a reduction of microbial
13
pathogens, such statements must be substantiated by processing documentation
14
and validated through the processing and Hazard Analysis and Critical Control
15
Point ( HACCP) system. Such validation and documentation of the HACCP system
16
would only be applicable in federally inspected establishments.
17
Because irradiation can substantially reduce and, in some situations, eliminate any
18
detectable level of pathogenic bacteria, it is important that the meat products be
19
held at the proper refrigerated temperatures to prevent growth of any pathogens
20
present, and that the packaging is not compromised.
21
irradiated beef with non-irradiated meat or poultry is not prohibited under the current
22
regulations, USDA/FSIS believes that such a process would decrease the benefit of
23
irradiation by potentially exposing the irradiated product to pathogenic bacteria.
Although commingling
Guam Food Code Annex 1 – Public Health Reasons
86
1
While FSIS considers such commingling to be highly unlikely, if it did occur, a
2
statement advising the consumer that the product contains both irradiated and non-
3
irradiated components would be required.
4
5
The Radura, International Symbol:
6
7
8
Further information about labeling irradiated raw meat is available through Directive
9
7700.1, Irradiation of Meat and Poultry Products, on the USDA/FSIS website at
10
http://www.fsis.usda.gov/oppde/rdad/fsisdirectives/7700-1.htm. Irradiation Questions &
11
Answers can be found at http://www.fsis.usda.gov/oppde/larc/policies/iradqa.pdf.
12
Labeling for Raw Shell Eggs
13
The Code of Federal Regulations 21 CFR 101.17 Food Labeling warning, notice,
14
and safe handling statements, paragraph (h) Shell eggs state in subparagraph (1),
15
“The label of all shell eggs, whether in intrastate or interstate commerce, shall bear
16
the following statement: ‘SAFE HANDLING INSTRUCTIONS: To prevent illness
17
from bacteria; keep eggs refrigerated, cook eggs until yolks are firm, and cook foods
18
containing eggs thoroughly.’” Further, in subparagraph (4) it states, “Shell eggs that
19
have been, before distribution to consumers, specifically processed to destroy all
Guam Food Code Annex 1 – Public Health Reasons
87
1
viable Salmonella shall be exempt from the requirements of paragraph (h) of this
2
section.”
3
Labeling for Whole-muscle, Intact Beef Steaks
4
In order for a food establishment operator to know that a steak is a whole-muscle,
5
intact cut of beef that can therefore be undercooked and served without a consumer
6
advisory, the incoming product must be labeled. Processors can accommodate this
7
need at the retail level by developing proposed labels, obtaining the necessary
8
USDA Food Safety Inspection Service review and approval, and appropriately
9
affixing the labels to their products.
10
Refer also to public health reason for § 3-602.11.
11
3-201.12
Food in a Hermetically Sealed Container.*
12
Processing food at the proper high temperature for the appropriate time is essential
13
to kill bacterial spores that, under certain conditions in an airtight container, begin to
14
grow and produce toxin. Of special concern is the lethal toxin of Clostridium
15
botulinum, an organism whose spores (i.e., survival stages for non-growth
16
conditions) are found throughout the environment. Even slight underprocessing of
17
low acid food which is canned can be dangerous, because spoilage microbes are
18
killed and there are no signs to warn consumers that botulinum spores have
19
germinated into vegetative cells and produced their toxin. If these foods are not
20
processed to be commercially sterile, they must be received frozen or under proper
21
refrigeration.
22
Refer also to the public health reason for §§ 3-101.11 and 3-201.11.
23
3-201.13
Fluid Milk and Milk Products.*
Guam Food Code Annex 1 – Public Health Reasons
88
1
Milk, which is a staple for infants and very young children with incomplete immunity
2
to infectious diseases, is susceptible to contamination with a variety of microbial
3
pathogens such as Shiga toxin-producing Escherichia coli, Salmonella spp., and
4
Listeria monocytogenes, and provides a rich medium for their growth. This is also
5
true of milk products.
6
contamination in milk and products derived from milk. Dairy products are normally
7
perishable and must be received under proper refrigeration conditions.
8
3-201.14
Pasteurization is required to eliminate pathogen
Fish.*
9
After December 18, 1997, all processors of fish are required by 21 CFR 123 to have
10
conducted a hazard analysis of their operation, identify each hazard that is
11
reasonably likely to occur, and implement a HACCP plan to control each identified
12
hazard. Retailers should assure that their seafood suppliers have complied with this
13
requirement. Hazards known to be associated with specific fish species are
14
discussed in the FDA Fish and Fishery Products Hazards and Controls Guide,
15
available from the FDA Office of Seafood.
16
pathogens, parasites, natural toxins, histamine, chemicals, and drugs.
17
The seafood implicated in histamine poisoning are the scombroid toxin-forming
18
species, defined in 21 CFR 123.3(m) as meaning bluefish, mahi-mahi, tuna, and
19
other species, whether or not in the family Scombridae, in which significant levels
20
of histamine may be produced in the fish flesh by decarboxylation of free histidine as
21
a result of exposure of the fish after capture to temperatures that allow the growth of
22
mesophilic bacteria.
Species-related hazards include
Guam Food Code Annex 1 – Public Health Reasons
89
1
Ciguatera toxin is carried to humans by contaminated fin fish from the extreme
2
southeastern U.S., Hawaii, and subtropical and tropical areas worldwide. In the
3
south Florida, Bahamian, and Caribbean regions, barracuda, amberjack, horse-eye
4
jack, black jack, other large species of jack, king mackerel, large groupers, and
5
snappers are particularly likely to contain ciguatoxin. Many other species of large
6
predatory fishes may be suspect. In Hawaii and throughout the central Pacific,
7
barracuda, amberjack, and snapper are frequently ciguatoxic, and many other
8
species both large and small are suspect. Mackerel and barracuda are frequently
9
ciguatoxic from mid to northeastern Australian waters.
10
RECREATIONALLY CAUGHT FISH
11
Recreationally caught fish received for sale or service may be approved by the
12
regulatory authority. The EPA recognizes that fish are a healthy part of our diet and
13
recognizes fishing as an all-American recreational pastime, however, they add the
14
cautionary note that some individuals, such as pregnant women and small children,
15
may need to limit their intake of certain noncommercial fish. Recreationally caught
16
fish may contain possible contaminants that may pose health risks. Fish advisories
17
can be found in EPA Listing of Fish Advisories the EPA website at:
18
http://www.epa.go/waterscience/fish.
19
States issue fish consumption advisories if elevated concentrations of chemicals
20
such as mercury or dioxin are found in local fish. For most people, the risk from
21
mercury by eating fish is not a health concern. Yet, some fish and shellfish contain
22
higher levels of mercury that may harm an unborn baby or young child's developing
23
nervous system. Therefore, the FDA and the EPA recently advised women who
Guam Food Code Annex 1 – Public Health Reasons
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1
may become pregnant, pregnant women, nursing mothers, and young children to
2
avoid some types of fish and eat fish and shellfish that are lower in mercury.
3
(http://www.epa.gov/waterscience/fishadvice/advice.html).
4
State-issued advisories apply primarily to non-commercial fish obtained through
5
sport, recreation, and subsistence activities. Each advisory is different; it may
6
recommend unrestricted, limited, or totally restricted consumption; may be targeted
7
to everyone or limited to women, children, or other people at risk; and may apply to
8
certain species or sizes of fish or a specific waterbody.
9
States may issue safe-eating guidelines in addition to issuing fish advisories. A fish
10
advisory is issued to warn the public of the potential human health risks from
11
chemical contamination of certain species from particular types of waterbodies such
12
as lakes, rivers, and/or coastal waters within the State. In contrast, a safe-eating
13
guideline is issued to inform the public that fish from specific waterbodies have been
14
tested for chemical contaminants and the fish from these waters are safe to eat
15
without consumption restrictions.
16
Regulatory authorities are encouraged to monitor and review the National Listing of
17
Fish
18
http://www.epa.gov/waterscience/fish/advisories/factsheet.pdf as well as the local
19
listings, as part of the decision-making process regarding the approval of
20
recreationally caught fish being used in food establishments.
21
Advisories
(See
3-201.15
August
2004
EPA
Fact
Sheet
at
Molluscan Shellfish.*
22
Pathogens found in waters from which molluscan shellfish are harvested can cause
23
disease in consumers.
Molluscan shellfish include: 1) oysters; 2) clams; 3)
Guam Food Code Annex 1 – Public Health Reasons
91
1
mussels; and, 4) scallops, except where the final product is the shucked adductor
2
muscle only. The pathogens of concern include both bacteria and viruses.
3
Pathogens from the harvest area are of particular concern in molluscan shellfish
4
because: 1) environments in which molluscan shellfish grow are commonly subject
5
to contamination from sewage, which may contain pathogens, and to naturally
6
occurring bacteria, which may also be pathogens; 2) molluscan shellfish filter and
7
concentrate pathogens that may be present in surrounding waters; and, 3)
8
molluscan shellfish are often consumed whole, either raw or partially cooked.
9
To minimize the risk of molluscan shellfish containing pathogens of sewage origin,
10
State and foreign government agencies, called Shellfish Control Authorities, classify
11
waters in which molluscan shellfish are found, based, in part, on an assessment of
12
water quality. As a result of these classifications, molluscan shellfish harvesting is
13
allowed from some waters, not from others, and only at certain times or under
14
certain restrictions from others. Shellfish Control Authorities then exercise control
15
over the molluscan shellfish harvesters to ensure that harvesting takes place only
16
when and where it has been allowed.
17
Significant elements of Shellfish Control Authorities' efforts to control the harvesting
18
of molluscan shellfish include: 1) a requirement that containers of in-shell molluscan
19
shellfish (shellstock) bear a tag that identifies the type and quantity of shellfish,
20
harvester, harvest location, and date of harvest; and, 2) a requirement that
21
molluscan shellfish harvesters be licensed; 3) a requirement that processors that
22
shuck molluscan shellfish or ship, reship, or repack the shucked product be certified;
Guam Food Code Annex 1 – Public Health Reasons
92
1
and, 4) a requirement that containers of shucked molluscan shellfish bear a label
2
with the name, address, and certification number of the shucker-packer or repacker.
3
Pathogens, such as Vibrio vulnificus, Vibrio parahaemolyticus, Vibrio cholerae,
4
and Listeria monocytogenes that may be present in low numbers at the time that
5
molluscan shellfish are harvested, may increase to more hazardous levels if they are
6
exposed to time/temperature abuse. To minimize the risk of pathogen growth,
7
Shellfish Control Authorities place limits on the time between harvest and
8
refrigeration. The length of time is dependant upon either the month of the year or
9
the average monthly maximum air temperature (AMMAT) at the time of harvest,
10
which is determined by the Shellfish Control Authority.
11
Paralytic shellfish poisoning (PSP) results from shellfish feeding upon toxic
12
microorganisms such as dinoflagellates. In the U.S., PSP is generally associated
13
with the consumption of molluscan shellfish from the northeast and northwest
14
coastal regions of the U.S. PSP in other parts of the world has been associated with
15
molluscan shellfish from environments ranging from tropical to temperate waters. In
16
addition, in the U.S., PSP toxin has recently been reported from the viscera of
17
mackerel, lobster, dungeness crabs, tanner crabs, and red rock crabs.
18
Neurotoxic shellfish poisoning (NSP) in the U.S. is generally associated with the
19
consumption of molluscan shellfish harvested along the coast of the Gulf of Mexico,
20
and, sporadically, along the southern Atlantic coast. There has been a significant
21
occurrence of toxins similar to NSP in New Zealand, and some suggestions of
22
occurrence elsewhere.
Guam Food Code Annex 1 – Public Health Reasons
93
1
For diarrhetic shellfish poisoning there has been no documented occurrence to date
2
in the U.S. However, instances have been documented in Japan, southeast Asia,
3
Scandinavia, western Europe, Chile, New Zealand, and eastern Canada.
4
Amnesic shellfish poisoning (ASP) is generally associated with the consumption of
5
molluscan shellfish from the northeast and northwest coasts of North America. It
6
has not yet been a problem in the Gulf of Mexico, although the algae that produce
7
the toxin have been found there. ASP toxin has recently been identified as a
8
problem in the viscera of dungeness crab, tanner crab, red rock crab, and anchovies
9
along the west coast of the United States.
10
Marine toxins are not ordinarily a problem in scallops if only the adductor muscle is
11
consumed. However, products such as roe-on scallops and whole scallops do
12
present a potential hazard for natural toxins.
13
To reduce the risk of illness associated with raw shellfish consumption, the Food and
14
Drug Administration (FDA) administers the National Shellfish Sanitation Program
15
(NSSP). The NSSP is a tripartite, cooperative action plan involving Federal and
16
State public health officials and the shellfish industry. Those groups work together to
17
improve shellfish safety. States regularly monitor waters to ensure that they are safe
18
before harvesting is permitted. FDA routinely audits the States' classification of
19
shellfish harvesting areas to verify that none pose a threat to public health.
20
Patrolling of closed shellfishing waters minimizes the threat of illegal harvesting or
21
“bootlegging” from closed waters. Bootlegging is a criminal activity and a major
22
factor in shellfish-borne illnesses. Purchases from certified dealers that adhere to
23
NSSP controls is essential to keep risks to a minimum.
Guam Food Code Annex 1 – Public Health Reasons
94
1
3-201.16
Wild Mushrooms.*
2
Over 5000 species of fleshy mushrooms grow naturally in North America. The vast
3
majority have never been tested for toxicity. It is known that about 15 species are
4
deadly and another 60 are toxic to humans whether they are consumed raw or
5
cooked. An additional 36 species are suspected of being poisonous, whether raw or
6
cooked. At least 40 other species are poisonous if eaten raw, but are safe after
7
proper cooking.
8
Some wild mushrooms that are extremely poisonous may be difficult to distinguish
9
from edible species. In most parts of the country there is at least one organization
10
that
include individuals who can provide assistance with both identification and
11
program design. Governmental agencies, universities, and mycological societies
12
are examples of such groups.
13
mushrooms, management must recognize and address the need for a sound
14
identification program for providing safe wild mushrooms.
15
Regulatory authorities have expressed their difficulty in determining what constitutes
16
a “wild mushroom identification expert” and enforcing the Food Code provisions
17
associated with it. In 1998, the Conference for Food Protection (CFP) attempted to
18
alleviate this problem through the formation of a committee that was charged with
19
determining what constitutes a wild mushroom expert. However, the committee was
20
unable to provide this information in a practical, useful manner for State and local
21
regulators within the constraints of the Food Code. The 2000 CFP recommended
22
and FDA accepted the committee’s alternative solution that a brochure be
23
developed that will provide information on what constitutes a wild mushroom expert,
If a food establishment chooses to sell wild
Guam Food Code Annex 1 – Public Health Reasons
95
1
and to replace “identification by a wild mushroom expert” with “written buyer
2
specifications.”
3
The CFP’s recommendation attempts to provide the necessary information in a
4
practical, useful manner for all stakeholders, and yet still convey the highest level of
5
public health protection.
6
specifications place more responsibility on the food establishment to ensure that wild
7
mushrooms are obtained from a safe source, and also provides State and local
8
regulators a template to use in ensuring wild mushrooms sold at retail are obtained
9
from a safe source.
The CFP committee suggested that written buyer
10
However, the recommendation for written buyer specifications will not replace Food
11
Code paragraph 3-201.16(A) until the brochure is developed and accepted by the
12
CFP and FDA. In the interim, the following guidance is provided regarding the
13
identification of wild mushrooms:
14
A food establishment that sells or serves mushroom species picked in the wild shall
15
have a written buyer specification that requires identification of:
16
(1)
17
The Latin binomial name, the author of the name, and the common
name of the mushroom species,
18
(2)
That the mushroom was identified while in the fresh state,
19
(3)
The name of the person who identified the mushroom,
20
(4)
A statement as to the qualifications and training of the identifier,
21
specifically related to mushroom identification.
22
Additional information can be found on the California Poison Control website:
23
http://www.calpoison.org/public/mushrooms.html.
Guam Food Code Annex 1 – Public Health Reasons
96
1
Refer also to the public health reason for §§ 3-101.11 and 3-201.11.
2
3-201.17
Game Animals.*
3
The primary concern regarding game animals relates to animals obtained in the wild.
4
Wild game animals may be available as a source of food only if a regulatory
5
inspection program is in place to ensure that wild animal products are safe. This is
6
important because wild animals may be carriers of viruses, rickettsiae, bacteria, or
7
parasites that cause illness (zoonoses) in humans. Some of these diseases can be
8
severe in the human host. In addition to the risk posed to consumers of game that
9
is not subject to an inspection program, there is risk to those who harvest and
10
prepare wild game because they may contract infectious diseases such as rabies or
11
tularemia.
12
Specifications
13
for Receiving
14
Temperature is one of the prime factors that controls the growth of bacteria in food.
15
Many, though not all, types of pathogens and spoilage bacteria are prevented from
16
multiplying to microbiologically significant levels in properly refrigerated foods that
17
are not out of date. USDA published a final rule (63 FR 45663, August 27, 1998
18
Shell Eggs; Refrigeration and Labeling Requirements) to require that shell eggs
19
packed for consumer use be stored and transported at an ambient temperature not
20
to exceed 7.2ºC (45ºF).
21
High temperatures for a long enough time, such as those associated with thorough
22
cooking, kill or inactivate many types of microorganisms. However, cooking does
23
not always destroy the toxins produced in foods by certain bacteria (such as the
3-202.11
Temperature.*
Guam Food Code Annex 1 – Public Health Reasons
97
1
enterotoxins of Staphylococcus aureus). Cooking or hot holding that follows
2
temperature abuse may not make the food safe. Keeping cooked foods hot as
3
required in the Code prevents significant regrowth of heat-injured microorganisms
4
and prevents recontamination with bacteria that are newly introduced.
5
3-202.12
Additives.*
6
It is imperative for safety that food supplies come from sources that are in
7
compliance with laws regarding chemical additives and contaminants.
8
Food additives are substances which, by their intended use, become components of
9
food, either directly or indirectly. They must be strictly regulated. In excessive
10
amounts or as a result of unapproved application, additives may be harmful to the
11
consumer. Unintentional contaminants or residues also find their way into the food
12
supply. The tolerances or safe limits designated for these chemicals are determined
13
by risk assessment evaluations based on toxicity studies and consumption
14
estimates.
15
Food and Color additives must be used in compliance with a federal food, or color
16
additive regulation, an effective food-contact notification, or a threshold of regulation
17
exemption. Such regulations, notifications, and exemptions are generally composed
18
of three parts: the identity of the substance, specifications including purity or
19
physical properties, and limitations on the conditions of use. In order for a food, or
20
color additive use to be in compliance, the use must comply with all three criteria.
21
Federal Food Additive regulations are found in Title 21 CFR, Parts 172-180. Color
22
additive regulations are found in Title 21 CFR Parts 73-Subpart A, 74-Subpart A, 81
23
and
82.
Effective
food-contact
notifications
Guam Food Code Annex 1 – Public Health Reasons
98
are
listed
at
1
http://vm.cfsan.fda.gov/~dms/opa-fcn.html, and threshold of regulation exemptions
2
are listed at http://www.cfsan.fda.gov/~dms/opa-torx.html.
3
Other substances that are added to food include those prior sanctioned for use in
4
food by either the FDA or USDA, or those generally recognized as safe for their
5
intended use in food. Some of these are listed in Title 21 CFR Parts 181-186, Title 9
6
CFR Section 424.21(b) and at http://www.cfsan.fda.gov/~rdb/opa-gras.html.
7
Tolerances and exemptions from tolerance for pesticide chemical residues in or on
8
food are found in Title 40 CFR Part 180. Substances that are prohibited from use in
9
human food are listed in Title 21 CFR Part 189.
10
3-202.13
Eggs.*
11
Damaged shells permit the entry of surface bacteria to the inside of eggs. Eggs are
12
an especially good growth medium for many types of bacteria. Damaged eggs must
13
not be used as food.
14
The Definition of “Restricted Egg” contains several terms that are explained in this
15
paragraph. An egg may be restricted because it is a/an:
16
(i)
17
18
but has its shell membranes intact and contents not leaking.
(ii)
19
20
“Check” meaning an egg that has a broken shell or crack in the shell
“Dirty egg or Dirties” meaning an egg that has a shell that is unbroken
and has adhering dirt, foreign material, or prominent stains.
(iii)
“Incubator reject” meaning an egg that has been subjected to
21
incubation and has been removed from incubation during the hatching
22
operations as infertile or otherwise unhatchable.
23
(iv)
“Inedible” meaning eggs of the following descriptions: Black rots,
Guam Food Code Annex 1 – Public Health Reasons
99
1
yellow rots, white rots, mixed rots, sour eggs, eggs with green whites,
2
eggs with stuck yolks, moldy eggs, musty eggs, eggs showing blood
3
rings, and eggs containing embryo chicks (at or beyond the blood ring
4
stage).
5
(v)
“Leaker” meaning an egg that has a crack or break in the shell and
6
shell membranes to the extent that the egg contents are exposed or
7
are exuding or free to exude through the shell.
8
(vi)
“Loss” meaning an egg that is unfit for human food because it is
9
smashed or broken so that its contents are leaking; or overheated,
10
frozen, or contaminated; or an incubator reject; or because it contains
11
a bloody white, large meat spots, a large quantity of blood, or other
12
foreign material.
13
On December 5, 2000, Federal regulations were amended to require that shell egg
14
cartons bear safe handling instructions and be placed under refrigeration at 45°F or
15
lower upon delivery at retail establishments (65 FR 76091, December 5, 2000, Food
16
Labeling, Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell
17
Eggs Held for Retail Distribution). The amended provisions include:
18

21 CFR Part 16 Regulatory Hearing before the Food and Drug
19
Administration, § 16.5 Inapplicability and limited applicability, (4) A
20
hearing on an order for re-labeling, diversion or destruction of shell
21
eggs…
22
23

21 CFR Part 101 Food Labeling §101.17 Food labeling warning,
notice, and safe handling statements, (h) Shell eggs.
Guam Food Code Annex 1 – Public Health Reasons
100
1

21 CFR Part 115 Shell Eggs, § 115.50. Refrigeration of shell eggs
2
held for retail distribution.
3
The labeling rule became effective September 4, 2001, and the refrigeration rule
4
became effective June 4, 2001. These rules are one part of a larger farm-to-table
5
approach for ensuring the safety of our nation’s egg supply. The public health goal
6
is a 50 percent reduction in all salmonellosis and a 50 percent reduction in
7
Salmonellae Enteritidis illnesses by 2010.
8
3-202.14
Eggs and Milk Products, Pasteurized.*
9
Liquid egg, fluid milk, and milk products are especially good growth media for many
10
types of bacteria and must be pasteurized. Pasteurization is a heat process that will
11
kill or inactivate bacteria and other harmful microorganisms likely to be in these
12
potentially hazardous foods (time/temperature control for safety foods). Freezing
13
and drying of unpasteurized products will stop microbial growth and may reduce
14
their bacterial populations; however, some organisms will survive because neither
15
process invariably kills bacteria. Under certain conditions, freezing and drying may
16
preserve microbes. An alternative to pasteurization may be applicable to certain
17
cheese varieties cured or aged for a specified amount of time prior to marketing for
18
consumption.
19
3-202.15
Package Integrity.*
20
Damaged or incorrectly applied packaging may allow the entry of bacteria or other
21
contaminants into the contained food. If the integrity of the packaging has been
22
compromised, contaminants such as Clostridium botulinum may find their way into
23
the food. In anaerobic conditions (lack of oxygen), botulism toxin may be formed.
Guam Food Code Annex 1 – Public Health Reasons
101
1
Packaging defects may not be readily apparent. This is particularly the case with
2
low acid canned foods. Close inspection of cans for imperfections or damage may
3
reveal punctures or seam defects. In many cases, suspect packaging may have to
4
be inspected by trained persons using magnifying equipment. Irreversible and even
5
reversible swelling of cans (hard swells and flippers) may indicate can damage or
6
imperfections (lack of an airtight, i.e., hermetic seal). Swollen cans may also
7
indicate that not enough heat was applied during processing (underprocessing).
8
Suspect cans must be returned and not offered for sale.
9
3-202.16
10
Freezing does not invariably kill microorganisms; on the contrary, it may
11
preserve them. Therefore, ice that comes into contact with food to cool it or that is
12
used directly for consumption must be as safe as drinking water that is periodically
13
tested and approved for consumption.
14
3-202.17
Ice.*
Shucked Shellfish, Packaging and Identification.
15
Plastic containers commonly used throughout the shellfish industry for shucked
16
product bear specific information regarding the source of the shellfish as required by
17
the NSSP Guide for the Control of Molluscan Shellfish. These containers must be
18
nonreturnable so that there is no potential for their subsequent reuse by shellfish
19
packers
20
identified by the label.
21
establishment must be assessed on the basis of the Food Code's criteria
22
for multi-use containers and the likelihood that they will be properly relabeled
23
to reflect their new contents.
which
could result
in
shucked
product that
is inaccurately
The reuse of these containers within the food
Guam Food Code Annex 1 – Public Health Reasons
102
1
3-202.18
Shellstock Identification.*
2
Accurate source identification of the harvesting area, harvester, and dealers
3
must be contained on molluscan shellstock identification tags so that if a
4
shellfish-borne disease outbreak occurs, the information is available to expedite
5
the epidemiological investigation and regulatory action.
6
3-202.19
Shellstock, Condition.
7
Dirty, damaged, or dead shellstock can contaminate and degrade live and
8
healthy
9
primary responsibility for culling shellstock, but this responsibility continues
10
shellstock
and lead to foodborne illness. Harvesters have the
throughout the distribution chain.
11
3-202.110
Juice Treated.
12
Refer to public health reason for § 3-801.11.
13
Original
14
Containers and
15
Records
16
Lot separation is critical to isolating shellfish implicated in illness outbreaks
17
and tracking them to their source. Proper identification is needed for tracing
18
the origin and determining conditions of shellfish processing and shipment. If
19
the lots are commingled at retail, traceability is undermined and the root of
20
the problem may remain undetected. If no causative factors are identified in
21
the food establishment, tracing the incriminated lot helps in identifying
22
products that need to be recalled or growing waters that may need to be
23
closed to harvesting.
3-203.11
Molluscan Shellfish, Original Container.
Guam Food Code Annex 1 – Public Health Reasons
103
1
When shucked shellfish are prepackaged in consumer self service containers,
2
the labeling information as specified under section 3-202.17 must be recorded
3
on a log sheet to correlate with the date of sale of the consumer sized
4
containers.
5
3-203.12
Shellstock, Maintaining Identification.*
6
Accurate records that are maintained in a manner that allows them to be
7
readily matched to each lot of shellstock provide the principal mechanism for
8
tracing shellstock to its original source.
9
authorities must move quickly to close affected growing areas or take other
10
appropriate actions to prevent further illnesses. Records must be kept for 90
11
days to allow time for hepatitis A virus infections, which have an incubation
12
period that is significantly longer than other shellfish-borne diseases, to come
13
to light. The 90 day requirement is based on the following considerations:
14
Shelf-life of the product ................................... 14 days
15
Incubation period .............................................. 56 days
16
Medical diagnosis and confirmation .................. 5 days
17
Reporting .......................................................... 5 days
18
Epidemiological investigation ............................ 10 days
19
Total .................................................................. 90 days
20
In reality and as stated in the provision, the 90-day “clock” starts at the
21
time the container of shellstock is emptied. Starting from the date of harvest
22
is not correct because the shellstock may be sold/consumed in less than the
If an outbreak occurs, regulatory
Guam Food Code Annex 1 – Public Health Reasons
104
1
14 days of shelf life cited in the chart above. Therefore, the 90 days may
2
expire and the tag discarded before an illness is reported and investigated.
3
Shellstock
4
estimated shelf life period, which would effectively stop the clock on the shelf
5
life. The shellstock could be thawed and consumed past the 14-day shelf life.
6
In
could
be frozen in the food establishment during the 14-day
this case, the 90 days would expire before consumption if the clock
7
started 90 days from the harvest date.
8
Freezing shellstock in the food establishment is not usually done because,
9
although
oysters-in-the-shell can be frozen with
fair results, they do not
10
have the same texture and appearance of a fresh oyster when thawed.
11
Commercially frozen oysters are frozen rapidly to retain product quality.
12
Preventing
13
Contamination
14
by Employees
15
In
16
Criteria for Foods (NACMCF) concluded that bare hand contact with ready-
17
to-eat foods can contribute to the transmission of foodborne illness and agreed
18
3-301.11
Preventing Contamination from Hands.*
November 1999, the National Advisory Committee for Microbiological
that
the transmission could be interrupted. The NACMCF recommended
19
exclusion/restriction of ill food workers as the first preventative strategy and
20
recognized that this intervention has limitations, such as trying to identify and
21
manage asymptomatic food workers.
22
The three interdependent critical factors in reducing foodborne illness transmitted
23
through the fecal-oral route, identified by the NACMCF, include exclusion/restriction
Guam Food Code Annex 1 – Public Health Reasons
105
1
of ill food workers; proper handwashing; and
2
ready-to-eat foods.
3
independently and may not be effective. However, when all three factors are
4
combined and utilized properly, the transmission of fecal-oral pathogens can
5
be controlled. Depending on the microbial contamination level on the hands,
6
handwashing with plain soap and water, as specified in the Food Code, may
7
not be an adequate intervention to prevent the transmission of pathogenic
8
microbes to ready-to-eat foods via hand contact with ready-to-eat foods.
9
Handwashing
as
no bare hand contact with
Each of these factors is inadequate when utilized
specified in the Food Code will reduce microbial
10
contamination of the hands by 2-3 logs.
11
Food employees and conditional employees infected with fecal-oral pathogens
12
can shed viral and protozoan pathogens in the feces at levels up to 108 viral
13
particles or oocysts per gram of feces. Having a high potential contamination
14
level on the hands combined with a very low infectious dose necessary to cause
15
infection are the reasons that FDA believes that handwashing alone is not an
16
effective single barrier in the transmission of these fecal-oral pathogens. The
17
infective dose for Giardia and Cryptosporidium is believed to be as low as 1-
18
10 oocysts, and as few as 10 virus particles can infect an individual with
19
Norovirus or hepatitis A.
20
The CDC now estimates that Norovirus is the leading cause of foodborne
21
illness in the United States. Contaminated hands are a significant factor
22
in
23
virus. Further, contamination of food by an infected food worker is the most
the transmission of enteric viruses, including Norovirus and hepatitis A
Guam Food Code Annex 1 – Public Health Reasons
106
1
common mode of transmission of hepatitis A in foodborne disease outbreaks.
2
Research has shown the viral transfer rate from contaminated hands to
3
ready-to-eat food to be about 10% and that proper handwashing will
4
significantly reduce the chance of transmitting pathogenic viruses. However,
5
with heavy initial contamination of the hands, especially in the subungal space
6
of the fingers, a basic 2-3 log reduction handwash procedure may not be
7
adequate to prevent the transmission of viral foodborne illness.
8
Even though bare hands should never contact exposed,
9
thorough handwashing is important in keeping gloves or other utensils from
ready-to-eat food,
10
becoming vehicles for transferring microbes to the food.
11
Refer to the public health reasons for §§ 2-301.11, 2-301.12, and 2-301.14.
12
3-301.11(D) Prior Approval for Food Employees to
13
Touch Ready-to-Eat Food with Bare Hands
14
Infected food employees are the source of contamination in approximately
15
one in five foodborne disease outbreaks reported in the United States with
16
a bacterial or viral cause.1 Most of these outbreaks involve enteric, i.e., fecal-
17
oral agents.
18
stools at the time the food was prepared.
19
handwashing procedures, workers spread these organisms to the food. In
20
addition, infected cuts,
21
contamination of food. Viral, bacterial, and parasitic agents can be involved.
These are organisms that employees were shedding in their
burns, or
boils
Because of poor or nonexistent
on hands can also result
in
22
1
Based on CDC Summary Surveillance for Foodborne-Disease Outbreaks – United States, 1988-1992 and New York
State Department of Health data 1980-1991 published: Weingold, Guzewich, Fudala, 1994, Use of Foodborne
Disease Data for HACCP Risk Assessment. J. Food Prot. 53: 820-830.
Guam Food Code Annex 1 – Public Health Reasons
107
1
Traditionally, food regulations have required two methods of preventing the
2
spread of foodborne disease by this mode of transfer, i.e., they have
3
prohibited food workers from preparing food when they are infectious and
4
have required thorough and frequent handwashing. In order to strengthen
5
fecal-oral transmission interventions, the Food Code provides focused and specific
6
guidance about ill workers and when handwashing must occur.
7
barrier, bare-hand contact with ready-to-eat food (i.e., food that is edible
8
without washing or is not subsequently subjected to a pathogen kill step) is
9
prohibited and suitable utensils such as spatulas, tongs, single-use gloves, or
As a final
10
dispensing equipment are required to be used.
11
requirement must convincingly address how food employees will be managed to
12
preclude food contamination and how management will ensure that thorough
13
handwashing occurs after employees use the toilet.
14
Because highly susceptible populations include persons who are
15
immunocompromised, the very young and elderly, establishments serving
16
these populations may not use alternatives to the no bare hand contact
17
with ready-to-eat food requirement.
18
Acceptability of an alternative procedure to no bare hand contact requires
19
prior approval from the regulatory authority based on the food establishment
20
having
21
complies with management of ill employees as specified under sections 2-
22
201.11 - .13 and management of handwashing practices as specified under
a
Any alternative to this
written employee health policy that details how the establishment
Guam Food Code Annex 1 – Public Health Reasons
108
1
Part 2-3 of the Code. The approval should also be based on evidence provided
2
through written procedures and documentation that at least all of the
3
following are addressed:
4
(A) Personal Cleanliness, i.e., handwashing procedures, including
5
frequency and methodology of handwashing that ensure food employees keep
6
their hands and fingertips clean and handwashing occurs at the times
7
specified in section 2-301.14, including after using the toilet and between tasks
8
that may recontaminate the hands.
9
(B) Hygienic Practices as specified in Part 2-4.
10
(C) Employee Health regarding:
11
(1) Reporting of diseases and medical conditions, and
12
(2) Exclusions and restrictions, i.e., that food employees and
13
conditional
14
section 2-201.11; ill food employees are restricted
15
specified in section 2-201.12; and the exclusions and restrictions are
16
removed as specified in section 2-201.13;
employees report their health status as specified in
or excluded as
17
(D) How the alternative practices and procedures will control the hazard
18
through an active managerial control program.
19
includes monitoring
20
described in paragraphs A-C above and satisfies the following:
Such a program
and verifying the institution of the provisions
21
(1) The public health hazard associated with bare hand contact
22
specific to the food establishment operation is identified and understood.
23
The regulatory authority needs assurance that the
Guam Food Code Annex 1 – Public Health Reasons
109
permit
holder
1
recognizes
that
the hazard
being
addressed
2
contamination of ready-to-eat food by viral and parasitic as well as
3
bacterial pathogens that are transferred from employees’ hands.
4
(2) The ready-to-eat foods that will be contacted with bare hands are
5
identified and both procedures and practices are in place so that
6
food employees wash their hands before returning to their work station
7
and cross-contamination from touching raw and ready-to-eat food is
8
precluded.
9
For example, identifying the specific type of food to be prepared,
10
such as tacos, and the specific location, such as a situation where a
11
food employee is assigned solely to the designated taco work
12
station. The work station is located immediately adjacent to the taco
13
assembly unit and the employee will be preparing only the specified
14
ready-to-eat food using bare hands.
15
Another example could be a food employee who is responsible solely for
16
assembling a variety of ready-to-eat foods.
17
(3) Institution of an effective training program for food employees that
18
emphasizes not working when ill with any of the gastrointestinal
19
symptoms listed in the Code, and explains good hygienic practices, proper
20
handwashing procedures, and safe food preparation procedures. This
21
should include a documented training plan that specifies how
22
management responsibility for training has been designated, training
Guam Food Code Annex 1 – Public Health Reasons
110
is
the
possible
1
program content, and the frequency of administration including periodic
2
refresher sessions.
3
(E) The
alternative
procedure
4
documentation, and verification actions to ensure that the practices and
5
procedures are followed. Corrective actions need to be predetermined for
6
situations where the practices and procedures are not followed, e.g., an
7
ill employee is found preparing foods.
8
(F) Documentation
9
related to an alternative to no bare hand contact with ready-to-eat food
10
must be maintained and readily available at the food establishment at all
11
times for use by the person in charge and for review by the regulatory
12
authority.
of
should
clearly
describe
monitoring,
the practices, procedures, and corrective actions
13
Preventing
14
Food and
15
Ingredient Contamination
16
With regard to the storage of raw animal foods as specified under subparagraph
17
3-302.11(A)(2), it is the intent of this Code to require separation based on
18
anticipated microbial load and raw animal food type (species). Raw animal foods
19
shall be separated based on a succession of cooking temperatures since
20
cooking temperatures as specified under § 3-401.11 are based on thermal
21
destruction data and anticipated microbial load.
22
cross-contamination, fish and pork, which are required to be cooked to an
23
internal temperature of 145°F for 15 seconds, shall be stored above or away
3-302.11
Packaged and Unpackaged Food – Protection
Separation, Packaging, and Segregation.*
For example, to
Guam Food Code Annex 1 – Public Health Reasons
111
prevent
1
from raw poultry, which is required to be cooked to an internal temperature of
2
165°F for 15 seconds due to its considerably higher anticipated microbial load.
3
In addition, raw animal foods having the same cooking temperature, such as
4
pork and fish, shall be separated from one another during storage and preparation
5
by maintaining adequate spacing or by placing the food in separate containers
6
because of the potential for allergen cross-contamination or economic
7
adulteration via inadvertent species substitution.
8
Food that is inadequately packaged or contained in damaged packaging could
9
become contaminated by microbes, dust, or chemicals introduced by products
10
or equipment stored in close proximity or by persons delivering, stocking,
11
opening packages
12
preventing the entry of microbes and other contaminants such as chemicals.
13
These contaminants may be present on the outside of containers and may
14
contaminate food if the packaging is inadequate or damaged, or when the
15
packaging is opened. The removal of food product overwraps may also
16
damage the package integrity of foods under the overwraps if proper care is
17
not taken.
18
or
3-302.12
19
overwraps.
or
Packaging must be appropriate for
Food Storage Containers, Identified with Common
Name of Food.
20
Certain foods may be difficult to identify after they are removed from their
21
original
22
ingredients.
packaging.
Consumers
may
be allergic
to
Guam Food Code Annex 1 – Public Health Reasons
112
certain
foods or
1
The mistaken use of an ingredient, when the consumer has specifically
2
requested that it not be used, may result in severe medical consequences.
3
The mistaken use of food from unlabeled containers could result in chemical
4
poisoning. For example, foodborne illness and death have resulted from the
5
use of unlabeled salt, instead of sugar, in infant formula and special dietary
6
foods. Liquid foods, such as oils, and granular foods that may resemble
7
cleaning compounds are also of particular concern.
8
3-302.13
9
Pasteurized Eggs, Substitute for Raw Shell Eggs for
Certain Recipes.*
10
Raw or undercooked eggs that are used in certain dressings or sauces are
11
particularly hazardous because the virulent organism Salmonella Enteritidis may
12
be present in raw shell eggs.
Pasteurized eggs provide an egg product
13
that is free of pathogens and is a ready-to-eat food. The pasteurized product
14
should be substituted in a recipe that requires raw or undercooked eggs.
15
3-302.14
Protection from Unapproved Additives.*
16
Refer to the public health reason for § 3-202.12.
17
Use of unapproved additives, or the use of approved additives in amounts
18
exceeding those allowed by food additive regulations could result in foodborne
19
illness, including allergic reactions. For example, many adverse reactions have
20
occurred because of the indiscriminate use of sulfites to retard “browning” of
21
fruits and vegetables or to cause ground meat to look “redder” or fresher.
22
The concern for misuse of additives also applies to food establishments
23
operating under a variance and to Annex 6 Food Processing Criteria of Model
Guam Food Code Annex 1 – Public Health Reasons
113
1
Food Code which addresses the use of sodium nitrite or other curing agents
2
in smoking and curing operations. However, if this process is done incorrectly, it
3
could cause illness or death because of excessive nitrite or because the food
4
is insufficiently preserved.
5
3-302.15
Washing Fruits and Vegetables.
6
Pathogenic organisms and chemicals may be present on the exterior surfaces
7
of raw fruits and vegetables. Washing removes the majority of organisms
8
and/or chemicals present. If nondrinking water is used, the fruits and vegetables
9
could become contaminated.
10
Toxic or undesirable residues could be present in or on the food if chemicals
11
used
12
concentrations.
13
On October 26, 1998, a voluntary guidance document which addresses
14
practices commonly used by fresh fruit and vegetable producers was issued
15
jointly
16
information related to washing fruits and vegetables as well as the application
17
of antimicrobial agents.
18
Hazards for Fresh Fruits and Vegetables” is available from FDA’s Food Safety
19
Initiative staff and also on the Internet at http://www.fda.gov/dms/prodguid.html.
for
washing
purposes are unapproved or applied in excessive
by FDA, USDA, and CDC.
This voluntary guidance contains useful
The “Guide to Minimize Microbial Food Safety
20
21
Preventing
22
Contamination
23
from Ice Used
3-303.11
Ice Used as Exterior Coolant, Prohibited as
Ingredient.
Guam Food Code Annex 1 – Public Health Reasons
114
1
as a Coolant
2
Ice that has been in contact with unsanitized surfaces or raw animal foods
3
may contain pathogens and other contaminants. For example, ice used to
4
store or display fish or packaged foods could become contaminated with microbes
5
present on the fish or packaging. If this ice is then used as a food
6
ingredient, it could contaminate the final product.
7
3-303.12
Storage or Display of Food in Contact with Ice and Water.
8
Packages that are not watertight may allow entry of water that has been
9
exposed to unsanitary exterior surfaces of packaging, causing the food to be
10
contaminated. This may also result in the addition of water to the food that is
11
unclaimed in the food's formulation and label.
12
Unpackaged foods such as fresh fish are often stored and/or displayed on ice.
13
A potential for increasing the microbial load of a food exists because,
14
as the ice melts, pathogens from one food may be carried by water to other
15
foods. The potential for contamination is reduced by continuous draining of
16
melting ice.
17
Preventing
18
Contamination
19
From Equipment,
20
Utensils, and
21
Linens
22
Pathogens can be transferred to food from utensils that have been stored
23
on surfaces which have not been cleaned and sanitized. They may also be
3-304.11 Food Contact with Equipment and Utensils.*
Guam Food Code Annex 1 – Public Health Reasons
115
1
passed on by consumers or employees directly, or indirectly from used
2
tableware or food containers.
3
Some pathogenic microorganisms survive outside the body for considerable periods
4
of time. Food that comes into contact directly or indirectly with surfaces that
5
are not clean and sanitized is liable to such contamination. The handles of
6
utensils, even if manipulated with gloved hands, are particularly susceptible to
7
contamination.
8
Probe-type price or identification tags are defined as a utensil. This means
9
that if such tags are for multiuse, they must meet the criteria listed in Parts
10
4-1 Materials for Construction and Repair, and 4-2 Design and Construction.
11
Probe-type price or product identification tags can cause microbial, chemical, or
12
physical contamination if not properly designed, constructed, and maintained.
13
The Food Code defines gloves as a “utensil” and therefore gloves must meet
14
the applicable requirements related to utensil construction, cleaning, and
15
storage.
16
3-304.12
In-Use Utensils, Between-Use Storage.
17
Refer to the public health reason for § 3-304.11.
18
Once a food employee begins to use a utensil such as a ladle, spatula, or
19
knife, that has been previously cleaned and sanitized, it is then considered an
20
in-use utensil. In-use utensils, used on a continuous or intermittent basis
21
during preparation or dispensing, must be cleaned and sanitized
22
schedule that precludes the growth of pathogens that may have been
23
introduced onto utensil surfaces.
on a
In-use utensils may be safely stored in hot
Guam Food Code Annex 1 – Public Health Reasons
116
1
water maintained at 135oF or above during intermittent use because microbial
2
growth is controlled at such temperatures.
3
A food utensil should be designed and used to prevent bare hand contact
4
with ready-to-eat food or to minimize contact with food that is not in a ready-
5
to-eat
6
improperly designed for the task or whether a food employee is misusing an
7
appropriately designed utensil.
8
form.
On-site evaluations can be made to determine if a utensil is
3-304.13
Linens and Napkins, Use Limitation.
9
Because of their absorbency, linens and napkins used as liners that contact
10
food must be replaced whenever the container is refilled. Failure to replace such
11
liners could cause the linens or napkins to become fomites.
12
3-304.14
Wiping Cloths, Use Limitation.
13
Soiled wiping cloths, especially when moist, can become breeding grounds for
14
pathogens that could be transferred to food. Any wiping cloths that are not
15
dry (except those used once and then laundered) must be stored in a sanitizer
16
solution at all times, with the proper sanitizer concentration in the solution.
17
Wiping cloths soiled with organic material can overcome the effectiveness of,
18
and neutralize, the sanitizer. The sanitizing solution must be changed as
19
needed to minimize the accumulation of organic material and sustain proper
20
concentration. Proper sanitizer concentration should be ensured by checking
21
the solution periodically with an appropriate chemical test kit.
22
3-304.15
23
Refer to the public health reason for § 3-304.11.
Gloves, Use Limitation.
Guam Food Code Annex 1 – Public Health Reasons
117
1
2
Gloves used in touching ready-to-eat food are defined as a “utensil” and must
meet the applicable requirements related to utensil construction, good
3
repair, cleaning, and storage.
4
Multiuse gloves, especially when used
5
breeding grounds for pathogens that could be transferred to food.
6
gloves can directly contaminate food if stored with ready-to-eat food or may
7
indirectly contaminate food if stored with articles that will be used in contact
8
with food.
9
activities that contaminate the gloves. Hands must be washed before donning
10
gloves. Gloves must be discarded when soil or other contaminants enter the
11
inside of the glove.
12
Slash-resistant gloves are not easily cleaned and sanitized. Their use with
13
ready-to-eat foods could contaminate the food.
14
Natural Rubber Latex (NRL) Gloves
15
Natural rubber latex gloves have been reported to cause allergic reactions in some
16
individuals who wear latex gloves during food preparation, and even in individuals
17
eating food prepared by food employees wearing latex gloves (refer to Annex
18
2, 3-304.15 of the 2005 Model Food Code). This information should be taken
19
into consideration when deciding whether single-use gloves made of latex will
20
be used during food preparation.
21
Although many allergic reactions occur as a result of occupational exposure, CFSAN
22
is actively reviewing its current policy on the use of disposable NRL gloves in food
23
operations in light of the possible transmission of the latex protein via food. To
repeatedly and soiled, can become
Soiled
Multiuse gloves must be washed, rinsed, and sanitized between
Guam Food Code Annex 1 – Public Health Reasons
118
1
gain additional information regarding allergic reactions allegedly
due to the
2
ingestion of food contaminated by NRL in retail settings, CFSAN has been
3
collecting reports of such reactions from consumers who have contacted the
4
Agency. Several offices within CFSAN will continue to collaborate in reviewing
5
incoming data. The results of these activities and other related efforts will be
6
used to determine if policy changes regarding
7
operations, based on food safety considerations, are warranted.
8
The FDA, Office of Food Additive Safety, Division of Food Contact Notification,
9
reviews gloves submitted for food-contact use in the food industry on the
10
basis of the glove’s formulation or components. FDA regulates NRL gloves
11
used for medical purposes only.
12
FDA is aware of the following information related to occupational hazards (
13
not food safety hazards) associated with the use of NRL gloves:
14

the use of latex in food
The National Institute for Occupational Safety and Health (NIOSH) published a
15
1997 Alert titled “Preventing Allergic Reactions to Natural Rubber Latex in
16
the Workplace” (NIOSH publication number 97-135) which is found at
17
http://www.cdc.gov/niosh/latexalt.html.
18

The American College of Allergy, Asthma and Immunology (ACAAI) and
19
the American Academy of Allergy Asthma and Immunology (AAAAI) issued a
20
joint statement discouraging the routine use of NRL gloves by food handlers.
21
(1997) http://www.acaal.org/public/physicians/joint.htm.
22
The AAAAI provides information on latex allergies on the web at
23
http://www.aaaai.org/patients/resources/fastfacts/latex_allergy.stm.
Guam Food Code Annex 1 – Public Health Reasons
119
1
The ACAAI provides information on latex allergies on the web at
2
http://www.acaai.org/public/facts/latex.htm.
3

An OSHA Technical Information Bulletin recommends reducing allergy
4
potential by reducing unnecessary exposure to NRL. Stating “Food service
5
workers ... do not need to use NRL gloves for food handling...” (1999)
6
http://www.osha.gov/dts/tib/tib_data/tib19990412.html.
7
OSHA addresses gloves in the following Federal regulation, which can be
8
found at:
9
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDAR
10
DS&p_id=9788.
11
OSHA Regulations (Standards - 29 CFR)
12
Standard Number: 1910.138
13
Standard Title: Hand Protection.
14
SubPart Number: I
15
SubPart Title: Personal Protective Equipment
16
(a) General requirements. Employers shall select and require employees to use
17
appropriate hand protection when employees' hands are exposed to hazards
18
such as those from skin absorption of harmful substances; severe cuts or
19
lacerations; severe abrasions; punctures; chemical burns; thermal burns; and
20
harmful temperature extremes.
21
(b) Selection. Employers shall base the selection of the appropriate hand
22
protection on an evaluation of the performance
characteristics of the hand
23
protection relative to the task(s) to be performed, conditions present, duration
24
of use, and the hazards and potential hazards identified.
Guam Food Code Annex 1 – Public Health Reasons
120
1
3-304.16
2
Using Clean Tableware for Second
Portions and Refills.
3
Refer to the public health reason for § 3-304.11.
4
3-304.17
Refilling Returnables.
5
Refer to the public health reason for § 3-304.11.
6
Preventing
3-305.11
Food Storage.
7
Contamination
3-305.12
Food Storage, Prohibited Areas.
8
from the
9
Premises
10
Pathogens can contaminate and/or grow in food that is not stored properly.
11
Drips of condensate and drafts of unfiltered air can be sources of microbial
12
contamination for stored food. Shoes carry contamination onto the floors of
13
food preparation and storage areas. Even trace amounts of refuse or wastes
14
in rooms used as toilets or for dressing, storing garbage or implements, or
15
housing machinery can become sources of food contamination. Moist conditions
16
in storage areas promote microbial growth.
17
18
3-305.13
Vended Potentially Hazardous Food (Time/Temperature
Control for Safety Food), Original Container.
19
The possibility of product contamination increases whenever food is exposed.
20
Changing the container(s) for machine vended potentially hazardous food
21
(time/temperature control for safety food) allows microbes that may be
22
present an opportunity to contaminate the food. Pathogens could be present
23
on the hands of the individual packaging the food, the equipment used, or
Guam Food Code Annex 1 – Public Health Reasons
121
1
the exterior of the original packaging. In addition, many potentially hazardous
2
foods
3
hermetically sealed state to ensure product safety. Once the original seal is broken,
4
the food is vulnerable to contamination.
(time/temperature
5
control
3-305.14
for
safety foods) are vended in a
Food Preparation.
6
Food preparation activities may expose food to an environment that may
7
lead to the food's contamination.
8
storage, it must also be protected during preparation. Sources of environmental
9
contamination
Just as food must be protected during
may include splash from cleaning operations, drips form
10
overhead air conditioning vents, or air from an uncontrolled atmosphere such as
11
may be encountered when preparing food in a building that is not constructed
12
according to Food Code requirements.
13
Preventing
14
Contamination
15
by Consumers
16
During display, food can be contaminated even when there is no direct hand contact.
17
Many microbes can be conveyed considerable distances on air currents
18
through fine sprays or aerosols. These may originate from people breathing or
19
sneezing, water sprays directed at drains, or condensate from air conditioners.
20
Even wind gusts across sewage deposits and fertilized fields have been known
21
to contaminate food in adjacent establishments where food was unprotected.
3-306.11
Food Display.
Guam Food Code Annex 1 – Public Health Reasons
122
1
3-306.12
Condiments, Protection.
2
Unpackaged condiments are exposed to contamination by consumers who could
3
be suffering from a disease transmissible through food. Once the condiments
4
are contaminated, subsequent consumers using the condiments may be exposed
5
to pathogens. Condiments in individual packages are protected from consumer
6
contamination.
7
On- or off-site facilities for refilling condiment dispensers must be adequately
8
equipped to ensure that the filling operation does not introduce contaminants.
9
3-306.13
Consumer Self-Service Operations.*
10
Raw foods of animal origin usually contain pathogens. In addition, these
11
foods, if offered for consumer self-service, could cross contaminate other
12
foods stored in the same display. Because raw foods of animal origin are
13
assumed to be contaminated and do provide an ideal medium for the growth of
14
pathogenic organisms, they should not be available for consumer self-service. Self-
15
service operations of ready-to-eat foods also provide an opportunity for
16
contamination by consumers. The risk of contamination can be reduced by
17
supplying clean utensils and dispensers and by employee monitoring of
18
these operations to ensure that the utensils and dispensers are properly used.
19
Bean sprouts that are displayed in produce areas for consumer self-service
20
are potentially hazardous foods (time/temperature control for safety foods) and
21
appropriate refrigeration must be maintained. However, they are not considered
22
ready-to-eat since they are intended to be washed by the consumer before
23
consumption.
Guam Food Code Annex 1 – Public Health Reasons
123
1
3-306.14
Returned Food and Re-Service or Sale.*
2
Food can serve as a means of person-to-person transmission of disease agents
3
such as hepatitis A virus. Any unpackaged foods, even bakery goods in a
4
bread basket that are not potentially hazardous (time/temperature control
5
safety foods) and that have been served to a consumer, but not eaten, can
6
become vehicles for transmitting pathogenic microorganisms from the initial
7
consumer to the next if the food is served again.
8
Preventing
9
Contamination
3-307.11
Miscellaneous Sources of Contamination.
10
from Other
11
Sources
12
This Code section provides a category in which to capture sources of contamination
13
not specifically delineated in Subparts 3-301 through 306. Codes prior to
14
1993 had such a provision for addressing food contamination for reasons
15
other than those elsewhere specified. Regardless of its specificity, a Code
16
can not anticipate all the diverse means by which food can become
17
contaminated after receipt.
18
Cooking
3-401.11
Raw Animal Foods.*
19
3-401.12
Microwave Cooking.*
20
3-401.13
Plant Food Cooking for Hot Holding.
21
Cooking, to be effective in eliminating pathogens, must be adjusted to a
22
number of factors. These include the anticipated level of pathogenic bacteria
23
in the raw product, the initial temperature of the food, and the food's bulk
Guam Food Code Annex 1 – Public Health Reasons
124
1
which affects the time to achieve the needed internal product temperature.
2
Other factors to be considered include post-cooking heat rise and the time
3
the food must be held at a specified internal temperature.
4
Greater numbers and varieties of pathogens generally are found on poultry
5
than
6
combination with the appropriate time is needed to cook these products.
7
To kill microorganisms, food must be held at a sufficient temperature for the
8
specified time. Cooking is a scheduled process in which each of a series of
9
continuous time/temperature combinations can be equally effective.
on other
raw
animal foods.
Therefore, a
higher
temperature, in
For
10
example, in cooking a beef roast, the microbial lethality achieved at 112
11
minutes after it has reached 54.4°C (130°F) is the same lethality attained as
12
if it were cooked for 4 minutes after it has reached 62.8°C (145°F). Cooked
13
beef and roast beef, including sectioned and formed roasts, chunked and formed
14
roasts, lamb roasts and cooked corned beef can be prepared using one of
15
the time and temperature combinations listed in the chart in § 3-401.11 to
16
meet a 6.5-log10
17
minimum that must be achieved and maintained in all parts of each piece of
18
meat for a least the stated time.
19
parameters is from the USDA/FSIS Appendix A. Compliance Guidelines For Meeting
20
Lethality Performance Standards For Certain Meat And Poultry Products found
21
at http://www.fsis.usda.gov/oa/fr/95033F-a.htm.
22
Cooking requirements are based in part on the biology of pathogens.
23
thermal destruction of a microorganism is determined by its ability to survive
reduction of Salmonella. The stated temperature is the
The source of the time and temperature
Guam Food Code Annex 1 – Public Health Reasons
125
The
1
heat.
Different species of microorganisms have different susceptibilities to
2
heat.
Also, the growing stage of a species (such as the vegetative cell of
3
bacteria, the trophozoite of protozoa, or the larval form of worms) is less
4
resistant than the same organism's survival form (the bacterial spore,
5
protozoan cyst, or worm egg).
6
Food characteristics also affect the lethality of cooking temperatures.
7
penetrates into different foods at different rates. High fat content in food reduces
8
the effective lethality of heat.
9
the moisture content of food aid thermal destruction.
Heat
High humidity within the cooking vessel and
10
Heating a large roast too quickly with a high oven temperature may char or
11
dry the outside, creating a layer of insulation that shields the inside from
12
efficient heat penetration. To kill all pathogens in food, cooking must bring all
13
parts of the food up to the required temperatures for the correct length of
14
time.
15
The temperature and time combination criteria specified in Part 3-4 of this
16
Code are based on the destruction of Salmonellae. This organism, if present
17
in raw shell eggs, is generally found in relatively low numbers. Other foods,
18
uncomminuted fish and meats including commercially raised game animal meat,
19
specified as acceptable for cooking at this temperature and time parameter are
20
expected to have a low level of internal contamination. The parameters are
21
expected to provide destruction of the surface contaminants on these foods.
22
Part 3-4 includes temperature and time parameters that provide “D” values
23
(decimal log reduction values) that may surpass 7D. For example, at 63oC
Guam Food Code Annex 1 – Public Health Reasons
126
1
(145oF), a time span of 15 seconds will provide a 3D reduction of
2
Salmonella Enteritidis in eggs.
3
The requirements specified under ¶ 3-401.11(D) acknowledge the rights of an
4
informed consumer to order and consume foods as preferred by that
5
consumer based on the consumer’s health status and understanding of the
6
risks associated with eating raw or partially-cooked animal foods.
7
In consumer self-service operations, such as buffets, salad bars, sushi bars, or
8
display cases, the consumer advisory as specified under section 3-603.11 must
9
be posted or available at the self-service unit where the raw or partially
10
cooked food is held for service and readily accessible to consumers prior to
11
making their food selections.
12
reception, guests are responsible for making their own requests or selections.
13
Slow-cooked roasts - Heating Deviations and Slow Come Up Time
14
(Source: USDA/FSIS Appendix A Compliance Guidelines For Meeting Lethality
15
Performance Standards For Certain Meat And Poultry Products found at
16
http://www.fsis.usda.gov/oa/fr/95033F-a.htm
17
Heating deviations, which most often involve slow come-up time or an
18
inordinate dwell time within the optimum temperature range for microorganism
19
growth can foster the multiplication of many pathogens. This multiplication
20
sometimes can be so prodigious that even recooking may be ineffective in
21
rendering
22
toxins
23
Staphylococcus aureus, are extremely heat stable and are not inactivated
the product safe.
into
the product.
In a catered situation, such as a wedding
Also, certain toxigenic bacteria can release
Some of
these toxins,
Guam Food Code Annex 1 – Public Health Reasons
127
such
as
those of
1
by normal recooking temperatures.
2
Further, the sampling of product following a heating deviation may not yield sufficient
3
information to determine the safety of the product in question. Heating
4
deviations can favor the multiplication of many types of bacteria. It would be
5
difficult and expensive to sample for all of them.
6
circumstances, establishments may want to use computer modeling to estimate
7
the relative multiplication of bacteria. For example, in a past
8
involving an extreme heating deviation, product was put in an oven in which
9
the temperature was inadvertently set to 95°F for about 12 hours. Computer
10
modeling was easily applied in this case because much of the dwell time was
11
at one temperature. The USDA/FSIS determined that within a 6-hour time
12
frame (with other growth conditions assumed to be favorable), the relative
13
multiplication of many pathogens of concern could have exceeded
14
Clearly
15
therefore destroyed.
16
computer modeling becomes more difficult. One approach is to average
17
lag/log times over small increments such as 5° and add these times to get
18
an approximation of possible total relative growth over a larger increment of
19
time. Establishments must keep in mind that the population of bacteria before
20
processing is generally unknown and that assumptions in the high range
21
often are used as input parameters in the modeling.
22
Seared Steak
the product could not be salvaged
by
Under changing conditions of
incident
5-logs.
reprocessing and
was
temperature, however,
Guam Food Code Annex 1 – Public Health Reasons
128
Depending on the
1
The provision for allowing seared steaks was reviewed by the National
2
Advisory Committee for Microbiological Criteria for Foods (NACMCF) and
3
USDA. Paragraph 3-401.11(C) includes their recommendations.
4
USDA comments included, “For the purposes of this discussion, steak is
5
a whole beef muscle.
6
been pinned, injected, or chopped and formed.
7
such as sirloin, chuck, or porterhouse; or it may be cut with the grain, such
8
as flank, skirt, or Chateaubriand. Other species, such as poultry, pork, and
9
lamb are not included.”
It does not include whole beef muscle that has
It may be cut cross grain,
10
NACMCF comments included, “Due to the low probability of pathogenic organisms
11
being present in or migrating from the external surface to the interior of beef
12
muscle, cuts of intact muscle (steaks) should be safe if the external surfaces
13
are exposed to temperatures sufficient to effect a cooked color change.
14
addition, the cut (exposed) surfaces must receive additional heat to effect a
15
complete sear across the cut surfaces. Grill or char marks may be applied to
16
the complete surface searing.
17
bottom surfaces utilizing a heating environment (e.g., grill or broiling oven)
18
that imparts
19
145oF to achieve a cooked color change on all external surfaces. The searing
20
of all surfaces should be continuous until the desired degree of doneness
21
and appearance are attained. This is considered a ready-to-eat food.”
22
As reflected in the definition of “whole-muscle, intact beef steak,” marination
23
is a food safety concern when the fascia (exterior surface) of the steak is
In
The meat should be seared on both top and
a temperature at the surface of the intact steak of at least
Guam Food Code Annex 1 – Public Health Reasons
129
1
broken by scoring or other means which allows the marinade to penetrate, and
2
potentially contaminate, the interior of the steak. In such cases, the Code
3
allowance for undercooking without a consumer advisory is negated.
4
Pork
5
In
6
parasites causing foodborne illness, are inactivated at temperatures below 145oF.
7
Therefore, pork roasts can be cooked like beef roasts (e.g., 145oF for 3
8
minutes) and pork chops cooked like steaks to achieve an internal
9
temperature of 145oF for 15 seconds.
pork, Trichinella
spiralis, Toxoplasma gondii, and Taenia solium,
10
Based on the Goodfellow and Brown study, a 5D reduction of organisms is
11
achieved at 68oC (155oF) for 15 seconds for the following foods: ratites and injected
12
meats and comminuted: fish, meat, game animals commercially raised for
13
food, and game animals that come under a USDA voluntary inspection program.
14
Ratites such as ostrich, emu, and rhea are included in this list of raw
15
animals foods because when cooked to a temperature greater than 68oC
16
(155oF), ratites exhibit a (metallic) “off” taste.
17
When USDA established the time and temperature parameters for 9 CFR 318.23
18
Heat-Processing and Stabilization Requirements for Uncured Meat Patties (known
19
as
20
extrapolations applied to the research done by Goodfellow and Brown to
21
account for the lack of a “come up, come down” time in the thin, small mass
22
beef patties. Consequently, there is no linear relationship between the patty
23
rule and roast beef time and temperature parameters. The patty rule also
the
“patty rule”),
the
Agency
based
the
5D
Guam Food Code Annex 1 – Public Health Reasons
130
for
Salmonella
on
1
provided for an 8D reduction in the number of Shiga toxin-producing
2
Escherichia coli. The time and temperature requirements in the Food Code
3
for comminuted meats are comparable to the USDA requirements.
4
Temperature for Comminuted Meat at Less Than 1 Second
5
In the “Report of the Task Force on Technical Issues Arising from the
6
National Advisory Committee for Microbiological Criteria for Foods (NACMCF)
7
Review of the Meat Patty Proposal” (undated), it is stated on page 7, in
8
Option (A), that:
9
“Based on the 1998 research data ... and an assumption that
10
instantaneous is defined as eight seconds, manufacturers would
11
be
12
temperature of 157oF. Given the lack of any significant margin of
13
safety in this process, there should be no deviation below the 158oF
14
requirement.”
required
to
process
fully-cooked
meat
patties
at
a
15
In November, 1997, the NACMCF Meat and Poultry Subcommittee revisited the time
16
and temperatures for cooking hamburger and advised FDA that cooking hamburger
17
to 158oF for less than one second is an adequate cook based on the following:
18
1.
The cooking recommendations contained in the Food Code
19
and in USDA guidance provide a large margin of safety
20
for killing vegetative enteric pathogens;
21
2.
The concept of integrated lethality (the kill imparted during
22
the entire heating and cooling process) adds to the
23
margin of safety; and
Guam Food Code Annex 1 – Public Health Reasons
131
1
3.
The time component of the time and temperature requirement
2
will
be
exceeded
3
determined.
before
the
temperature
can be
4
The parameters for cooking poultry, wild game animal meats, stuffed food products,
5
etc., of 74oC (165oF) or above for 15 seconds yield greater than a 7D
6
reduction.
7
3-401.12
8
The rapid increase in food temperature resulting
9
does not provide the same cumulative time and temperature relationship
10
necessary for the destruction of microorganisms as do conventional cooking
11
methods.
12
temperature of 74oC (165oF) in all parts of the food. Since cold spots may
13
exist in food cooking in a microwave oven, it is critical to measure the food
14
temperature at multiple sites when the food is removed from the oven and
15
then allow the food to stand covered for two minutes post microwave heating
16
to allow thermal equalization and exposure.
17
ovens are designed and engineered to deliver energy more evenly to the
18
food than others, the important factor is to measure and ensure that the final
19
temperature reaches 74oC (165oF) throughout the food.
20
“The factors that influence microwave thermal processes include many of the same
21
factors that are important in conventional processes (mass of objects, shape
22
of objects, specific heat and thermal conductivity, etc.).
23
factors are unique in affecting microwave heating, due to the nature of the
In
order
Microwave Cooking.*
from microwave heating
to achieve comparable lethality, the food must attain a
Although
Guam Food Code Annex 1 – Public Health Reasons
132
some microwave
However, other
1
electric field involved in causing molecular friction.
2
exemplified by moisture and salt contents of foods, which play a far more
3
important role in microwave than conventional heating.” (Reference: Heddelson
4
and Doores, see 2005 Model Food Code Annex 2)
5
3-401.13
These factors are
Plant Food Cooking for Hot Holding.
6
Fruits and vegetables that are fresh, frozen, or canned and that are heated
7
for hot holding need only to be cooked to the temperature required for hot
8
holding. These foods do not require the same level of microorganism destruction
9
as do raw animal foods since these fruits and vegetables are ready-to-eat at
10
any temperature.
Cooking to the hot holding temperature of 57°C (135°F)
11
prevents the growth of pathogenic bacteria that may be present in or on these
12
foods. In fact, the level of bacteria will be reduced over time at the specified
13
hot holding temperature.
14
Freezing
15
Refer to the public health reason for § 3-201.11.
16
Lightly cooked, raw, raw-marinated, and cold-smoked fish may be desired by
17
consumers for taste or perceived nutritional reasons.
18
destruction of parasites, fish may be frozen before service as an alternative
19
public health control to that which is provided by adequate cooking. Candling
20
or other visual inspection techniques are not adequate to avoid the risk of
21
parasites from fish which have not been frozen.
3-402.11
Parasite Destruction.*
Guam Food Code Annex 1 – Public Health Reasons
133
In order to
ensure
1
The recommended control strategies refer to the ambient air temperature during
2
freezing and to the length of time that the fish is held at the appropriate freezer
3
temperature, or the length of time that the fish is held after it is solid
4
frozen, whichever is appropriate. The parasite hazard is not considered to be
5
reasonably likely to occur if the finished product is fish eggs that have been removed
6
from the skein (the tissue that contains the egg mass) and rinsed.
7
In response to information provided to the FDA Office of Seafood, the Fish
8
and Fisheries Products Hazards and Controls Guidance lists certain species of
9
tuna as not being susceptible to parasites of concern and therefore exempted
10
from the freezing requirements that
11
consumed raw.
12
The Fish and Fisheries Products Hazards and Controls Guidance states that
13
species that normally have parasites as a result of consuming infected prey,
14
apparently do not have the same parasite hazard when raised on pelleted
15
food in an aquaculture operation. On the other hand, aquacultured fish that are
16
fed processing waste and by-catch fish may have a parasite hazard, even
17
when wild caught fish of that species do not normally have a
18
hazard. Feed must not contain any live parasites. For example, the use of
19
fresh fish meat in feed could transmit such parasites. Only heat treated feed
20
or feed otherwise produced in a manner that would kill parasite intermediate
21
stages infective to the aquacultured fish, such as most pelleted feeds, should
22
be used.
23
3-402.12
apply to other fish species
Records, Creation and Retention.
Guam Food Code Annex 1 – Public Health Reasons
134
that are
parasite
1
Records must be maintained to verify that the critical limits required for food
2
safety are being met. Records provide a check for both the operator and the
3
regulator in determining that monitoring and corrective actions have taken
4
place.
5
While the Country of Origin Labeling requirements, http://www.ams.usda.gov/COOL/
6
effective Sept. 30, 2004, mandate identification of wild and farm-raised fish and
7
shellfish, the requirements do not address contents of pelleted feed used in the
8
aquaculture operation. Documentation must be available in the food establishment
9
from the source-through-purchase specifications or labeling that pelleted feed used
10
did not contain fresh fish or plankton. Follow the guidance provided in The Fish and
11
Fisheries Products Hazards
12
Vertebrate Species Related Hazards and Table #3-2 - Potential Invertebrate
13
Species Related Hazards.
14
Reheating
15
When food is held, cooled, and reheated in a food establishment, there is an
16
increased risk
17
procedures, or other factors. If food is held at improper temperatures for enough
18
time, pathogens have the opportunity to multiply to dangerous numbers. Proper
19
reheating provides a major degree of assurance that pathogens will be
20
It is especially effective in reducing the numbers of Clostridium perfringens that
21
may grow in meat, poultry, or gravy if these products were improperly cooled.
22
Vegetative cells of C. perfringens can cause foodborne
23
to high numbers. Highly resistant C. perfringens spores will survive cooking and
3-403.11
from
and
Controls Guidance Table #3-1 - Potential
Reheating for Hot Holding.*
contamination
caused
by
personnel,
eliminated.
illness when they grow
Guam Food Code Annex 1 – Public Health Reasons
135
equipment,
1
hot holding. If food is abused by being held at improper holding temperatures or
2
improperly cooled, spores can germinate to become rapidly multiplying vegetative
3
cells.
4
Although proper reheating will kill most organisms of concern, some toxins
5
such as that produced by Staphylococcus aureus, cannot be inactivated
6
through reheating of the food. It is imperative that food contamination be
7
minimized to avoid this risk.
8
The potential for growth of pathogenic bacteria is greater in reheated cooked
9
foods than in raw foods. This is because spoilage bacteria, which inhibit the
10
growth of pathogens by competition on raw product, are killed during cooking.
11
Subsequent recontamination will allow pathogens to grow without competition if
12
temperature abuse occurs.
13
Refer also to the public health reason for § 3-401.12.
14
3-404.11
Treating Juice.
15
Refer to the public health reason for § 3-801.11.
16
Temperature and
3-501.11
Frozen Food.
Guam Food Code Annex 1 – Public Health Reasons
136
1
Time Control
3-501.12
Potentially Hazardous Food
2
(Time/Temperature Control for Safety
3
Food), Slacking.
4
3-501.13
Thawing.
5
Freezing prevents microbial growth in foods, but usually does not destroy all
6
microorganisms. Improper thawing provides an opportunity for surviving
7
bacteria to grow to harmful numbers and/or produce toxins. If the food is
8
then refrozen, significant numbers of bacteria and/or all preformed toxins are
9
preserved.
10
3-501.14
Cooling.*
11
Safe cooling requires removing heat from
food quickly enough to prevent
12
microbial growth. Excessive time for cooling of potentially hazardous foods
13
(time/temperature control for safety foods) has been consistently identified as
14
one of the leading contributing factors to foodborne illness. During slow cooling,
15
potentially
16
subject to the growth of a variety of pathogenic microorganisms.
17
time near ideal bacterial incubation temperatures, 21oC - 52oC (70oF - 125oF),
18
is to be avoided. If the food is not cooled in accordance with this Code
19
requirement, pathogens may grow to sufficient numbers to cause foodborne
20
illness.
21
The Food Code provision for cooling provides for cooling from 135ºF to 41F or 45F
22
in 6 hours, with cooling from 135ºF to 70F in 2 hours. The 6-hour cooling
23
parameter, with an initial 2-hour rapid cool, allows for greater flexibility in
hazardous foods (time/temperature control for safety foods)
Guam Food Code Annex 1 – Public Health Reasons
137
are
A longer
1
meeting the Code. The initial 2-hour cool is a critical element of this cooling
2
process. An example of proper cooling might involve cooling from 135ºF to
3
70ºF in 1 hour, in which case 5 hours remain for cooling from 70ºF to
4
41ºF or 45ºF.
5
achieved in 6 hours, but the initial cooling to 70ºF took 3 hours, the food
6
safety hazards may not be adequately controlled.
7
If the cooking step prior to cooling is adequate and no recontamination
8
occurs, all but the spore-forming organisms such as Clostridium perfringens
9
or
Conversely, if cooling from 135ºF to 41F
Bacillus cereus
should
be
killed
or
inactivated.
or
45F is
However, under
10
substandard sanitary conditions, other pathogens such as Salmonella or
11
Listeria monocytogenes may be reintroduced. Thus, cooling requirements
12
are based on growth characteristics of organisms that may survive or be a
13
post-cook contaminate and grow rapidly under temperature abuse conditions.
14
Shell Eggs
15
FDA has approved the use of ionizing radiation for shell eggs. This approval
16
means that FDA has not found the ionizing radiation process to be unsafe
17
for shell eggs. However, shell eggs that have been subjected to the
18
approved
19
pasteurized.
20
subjected to a 5-log kill process for Salmonella Enteritidis, while the approved
21
ionizing radiation process may deliver only 2 or 3 logs reduction. Therefore,
22
eggs treated by ionizing radiation process alone must be held under
23
refrigeration, as it cannot be guaranteed that Salmonella Enteritidis will be
ionizing
radiation process
Shell egg
are
not
considered to have been
pasteurization requires the egg to have been
Guam Food Code Annex 1 – Public Health Reasons
138
1
eliminated in all treated eggs.
Further, irradiated eggs must be labeled in
2
accordance with 21 CFR 179.26 Ionizing radiation for the treatment of food.
3
Hard-boiled eggs with shell intact may be cooled in ambient air and are not
4
considered to be a potentially hazardous food (time/temperature control for
5
safety food) after cooling. Hard-boiled eggs may be cooled in drinking water
6
but are considered to be a potentially hazardous food (time/temperature control
7
for safety food) after cooling because pathogens, which may be present in
8
the water, may pass through the egg shell during cooling.
9
Salmonella Enteritidis has been shown to have an extended lag phase in
10
shell eggs due to inhibitory characteristics of the albumen.
11
indicates that the organisms are physically located near the exterior of the
12
yolk membrane, in contact with the bacteriostatic components.
13
not appear until the yolk membrane is weakened by age or physically
14
breached and the yolk nutrients, such as iron, become available to the
15
organisms.
16
Federal
17
transported and distributed under refrigeration at an ambient temperature not to
18
exceed 45°F. Packed shell eggs must be labeled indicating that refrigeration is
19
required. Imported shell eggs packed for consumer use are required to include
20
a certification that the eggs, at all times after packing, have been stored and
21
transported at an ambient temperature of no greater than 45°F.
22
On December 5, 2000, federal regulations were amended to require that shell
23
egg cartons bear safe handling instructions and be placed under refrigeration
regulations
effective
Research
Growth does
August 27, 1999, require shell eggs to be
Guam Food Code Annex 1 – Public Health Reasons
139
1
at 45° F or lower upon delivery at retail establishments (65 FR 76091,
2
December 5, 2000, Food Labeling, Safe Handling Statements, Labeling of
3
Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution). The
4
amended provisions include:
5

21 CFR Part 16 Regulatory Hearing before the Food and Drug
6
Administration, § 16.5. Inapplicability and limited applicability, (4) A
7
hearing on an order for re-labeling, diversion or destruction of
8
shell eggs…
9

10
11
12
21 CFR Part 101 Food Labeling § 101.17. Food labeling warning,
notice, and safe handling statements, ( h) Shell eggs.

21 CFR Part 115 Shell Eggs, § 115.50 Refrigeration of shell
eggs held for retail distribution.
13
Shell eggs must be placed immediately after receipt in refrigerated equipment
14
that is capable of maintaining an ambient air temperature of 45°F.
15
newly established Federal requirement for eggs to be in an ambient storage
16
and transportation temperature of 45°F, and with refrigeration of eggs at retail
17
as described above, the overall time that eggs are stored at temperatures that allow
18
the growth of Salmonella spp. should be shortened. Additionally, this requirement
19
negates the need to
20
establishment operators should maximize the circulation of cooled air in
21
refrigeration units by separating flats, cases, and multiple cartons of eggs.
22
23
With the
“cool” shell eggs upon receipt, although food
CFSAN/FSIS Joint Position Paper on Cooling
The processing
of most ready-to-eat products includes a heat treatment or
Guam Food Code Annex 1 – Public Health Reasons
140
1
cooking step to eliminate pathogenic and spoilage microorganisms. However,
2
this heat treatment does not eliminate spores of Clostridium botulinum and
3
Clostridium perfringens and other spore-forming bacteria. Furthermore, these
4
organisms can thrive in the warm product since other competing organisms
5
have been eliminated. Non-refrigerated, anaerobic conditions are conducive
6
to their growth and multiplication.
7
To prevent the growth and multiplication of spore-forming organisms, product
8
should be
9
cooling, spores can germinate and the resulting vegetative cells can multiply
10
to hazardous levels. The presence of sufficient numbers of C. botulinum or
11
other spore-forming organisms may lead to production of harmful toxins. Therefore,
12
ensuring no growth of these organisms will provide the greatest amount of safety.
13
The USDA/FSIS Performance Standards for the Production of Certain Meat
14
and Poultry Products require a stabilization step (cooling) after the lethality
15
step. The stabilization requirements allow for no growth of C. botulinum
16
and no more than 1 log growth of C. perfringens.
17
standard of no more than 1 log growth of C. perfringens was based on the following
18
reasons:
19
1.
cooled rapidly after cooking.
When
there
is
inadequate
The performance
The Centers for Disease Control and Prevention (CDC) suggested viable
20
counts of 105 or greater of C. perfringens per gram as one of the criteria for
21
incriminating C. perfringens as a causative agent of foodborne illness in
22
finished product. However, foods responsible for C. perfringens outbreaks
23
were found usually to contain 106 vegetative C. perfringens cells per gram.
Guam Food Code Annex 1 – Public Health Reasons
141
1
In
2
contain more than 1000
3
probability that greater than 104 C. perfringens per gram can occur in the
4
raw product on rare occasions. It is a conservative assumption that the
5
great majority of C. perfringens in the raw product are spores.
6
2.
FSIS microbiological raw product surveys, samples were found to
C. perfringens per gram. There is some
Heating activates spores that, during cooling, become vegetative cells that
If there are more than 104 C.
7
can multiply to hazardous levels.
8
perfringens (spores) per gram on raw product, it is possible that there
9
may be more than 104 vegetative C. perfringens per gram in the product
10
11
if it is improperly cooled after cooking.
3.
Based on the CDC recommended upper limit of 105 which should not be
12
exceeded, it was determined that a limit of no more than 1 log10 growth
13
of C. perfringens would be appropriate to ensure that there would be no
14
more than 105 C. perfringens per gram on the finished product after
15
cooling.
16
4.
The
performance
standard was discussed with experts on clostridia
17
research.
The experts agreed that limiting the relative growth of C.
18
perfringens to no more than 1 log10 would be reasonable and somewhat
19
conservative with respect to product safety. (64 FR 732, January 6, 1999,
20
Performance Standards for the Production of Certain Meat and Meat
21
Products).
22
The FSIS compliance guideline for the cooling performance standards, which
23
can
be
found
at
http://www.fsis.usda.gov/oa/fr/95033F-b.htm
Guam Food Code Annex 1 – Public Health Reasons
142
Compliance
1
Guidelines for Cooling Heat-Treated Meat and Poultry Products (Stabilization),
2
is that product must be cooled from 130ºF to 80F in 1.5 hours and from
3
80ºF to 40F in 5 hours. This cooling rate can be applied universally to
4
cooked products like partially cooked or fully cooked, intact or non-intact
5
meat and poultry products.
6
cooling of the product in the temperature range where the spore-forming organisms
7
can grow rapidly.
8
The former USDA guideline of cooling from 120ºF to 55F in no more
9
than 6 hours is also included in the new compliance guidelines.
The guideline results in continuous and rapid
In using
10
this guideline, chilling should begin within 90 minutes after the cooking cycle
11
is completed, and cooling should continue until product reaches 40F. The 6-
12
hour rule begins when the product reaches 120ºF, and product should not
13
be shipped until the product reaches 40F.
14
results in a significantly smaller margin of safety, especially if the product is
15
non-intact. In using this older guideline, the establishment has to ensure that
16
cooling is as rapid as possible, especially between 120ºF and 80F, and
17
should monitor the cooling closely to prevent any deviation. If product remains
18
between these temperatures for more
19
performance standard is less certain.
20
The FSIS cooling guideline for meat and poultry products containing 100
21
ppm added nitrite is 130ºF to 80F in 5 hours and from 80ºF to 45F in 10
22
hours, a total of 15 hours cooling time. This cooling process provides a narrow
23
margin of safety. In case of cooling deviations,
than
This older cooling guideline
an
hour, compliance with the
the establishment should
Guam Food Code Annex 1 – Public Health Reasons
143
1
assume that their process has
exceeded
2
controlling the growth of C. perfringens, and should take corrective action.
3
However, the
4
performance standard for C. botulinum.
5
The Food Code provision for cooling is similar, though not identical to the
6
FSIS cooling compliance guidelines.
7
70F in 2 hours and from 135ºF to 41F or 45F in 6 hours and is based
8
on the same food safety concerns as FSIS’ guidance.
9
provides prescriptive cooling time/temperature combinations without a HACCP
presence of nitrite should
the performance standard for
ensure compliance with the
It provides for cooling from 135ºF to
The Food Code
10
plan in place.
Federally inspected meat and poultry establishments are
11
required to implement a HACCP plan for their operations.
12
The Conference for Food Protection (CFP) at its 2000 meeting recommended
13
that FSIS and FDA ask the National Advisory Committee on Microbiological
14
Criteria for Foods (NACMCF) to review the data on safe cooling times for
15
cooked, potentially hazardous foods (time/temperature control for safety foods).
16
The review would include data from a study, submitted to the CFP, showing
17
that cooling of a meat product from 130ºF to 45F can safely take place in
18
15 hours based on a study by V.K. Juneja, et al., 1994. According to the
19
authors of the study, continuous cooling of a meat product from 130ºF to
20
45F in 15 hours permitted about 1 log growth of C. perfringens.
21
In response to the CFP recommendation, the FSIS Administrator and CFSAN
22
agreed that the data referenced in the CFP recommendation do not support a
23
change in the FSIS guidance or the Food Code § 3-501.14 and considered
Guam Food Code Annex 1 – Public Health Reasons
144
1
it inadvisable to ask the NACMCF to undertake the task requested for
2
several reasons:
3
1.
The study did not address growth of C. botulinum.
4
2.
The results are from a carefully controlled laboratory study in which
5
cooling of the product was steady and continuous, conditions difficult to
6
maintain in most commercial processing or retail environments even with
7
data loggers and other control mechanisms in place.
8
9
10
3.
The study was done only on ground beef and may not be applicable to
other meat and poultry or to other potentially hazardous
foods
(time/temperature control for safety foods).
11
As an alternative response, CFSAN and FSIS advised CFP that they would
12
provide this written position paper to clarify their joint position on the cooling
13
issues.
14
3-501.15
Cooling Methods.
15
Large food items, such as roasts, turkeys, and large containers of rice or
16
refried beans, take longer to cool because of the mass and volume from
17
which heat must be removed.
18
individual container,
19
opportunity for pathogen growth is minimized. If the hot food container is
20
tightly covered, the rate of heat transfer is reduced, i.e., the time required for
21
cooling and the time the food is exposed to optimal temperatures for bacterial
22
multiplication or toxin production are increased.
23
Alternatives to conventional methods include avoiding the need to cool
By reducing the volume of the food in an
the rate of cooling is dramatically increased and
Guam Food Code Annex 1 – Public Health Reasons
145
1
larger masses by preparing smaller batches closer to periods of service or
2
chilling while stirring hot food in containers within an ice water bath.
3
Commercial refrigeration equipment is designed to hold cold food temperatures,
4
not cool large masses of food. Rapid chilling equipment is designed to cool the
5
food to acceptable temperatures quickly by using very low temperatures and
6
high rates of air circulation.
7
3-501.16
8
Potentially Hazardous Food (Time/Temperature
Control for Safety Food), Hot and Cold Holding.*
9
Bacterial growth and/or toxin production can occur if potentially hazardous
10
food (time/temperature control for safety food) remains in the temperature “Danger
11
Zone” of 5oC to 57oC (41oF to 135oF) too long.
12
growth increases with an increase in temperature within this zone. Beyond the
13
upper limit of the optimal temperature range for a particular organism, the rate
14
of growth decreases. Operations requiring heating or cooling of food should
15
be performed as rapidly as possible to avoid the possibility of bacterial growth.
Up to a point, the rate of
16
17
Cold Holding
18
Except for raw shell eggs, control of the growth of Listeria monocytogenes
19
(Lm)
20
combinations in paragraph 3-501.17(A). The list addresses time, in addition
21
to temperature, as a control for the growth of Lm in refrigerated, ready-to-
22
eat, potentially hazardous food (time/temperature control for safety food). The
23
Code provisions for cold holding focus on environmental conditions that allow
is
the basis for the list of cold holding temperature and time
Guam Food Code Annex 1 – Public Health Reasons
146
1
1 log of growth of Lm, and do not set an acceptable number of Lm in
2
food. Neither do they imply that Lm is in the product.
3
The times and temperatures in the 1999 Food Code were based on the
4
USDA
5
estimating
6
based largely on observations of microbial
7
some observations in specific foods were also included. The PMP allows for
8
some variation in temperature, pH,
9
conservative estimate of safe times and temperatures for holding foods. The
10
1999 Food Code estimated safe times and temperatures that would allow 3
11
logs of growth, based on the PMP.
12
During 2000, CFSAN researched published literature and compiled a listing
13
of the growth potential of Lm in various food commodities using real food
14
data.
15
temperatures of 41ºF for 7 days and 45ºF for 4 days were validated, but the
16
underlying performance standard changed for the commodities studied. The
17
research-based, food-specific times and temperatures allow no more than 1
18
log of growth instead of the 3 log growth predicted in the PMP.
19
stringent performance standard of 1 log is consistent with the USDA/FSIS
20
performance standard and the fact that the infectious dose of Lm remains
21
unknown.
22
FDA concluded that the 1999 Code time/temperature criteria hold true and
23
provide both a greater level of safety and a more realistic basis for regulatory
Pathogen Modeling Program (PMP), which is conservative in
how soon Lm begins to grow and how fast.
Based on
growth
The PMP was
in broth cultures, but
and water activity, and gives a
this information, the 1999 Food Code times and
Guam Food Code Annex 1 – Public Health Reasons
147
This more
1
requirements without compromising public health protection.
2
In
3
released the Quantitative Assessment of the Relative Risk to Public Health from
4
Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat
5
Foods (risk assessment).
6
separate risk assessments and analysis of the relative risks of serious illness
7
and death associated with consumption of 23 categories of ready-to-eat
8
foods. These categories included: seafood, produce, meats, dairy products, and
9
deli salads.
October 2003, FDA, in cooperation with the USDA/FSIS and CDC,
This initiative included
the development of 23
10
The risk assessment identified several broad factors that affect consumer exposure
11
to Lm at the time of food consumption. Two of these factors, refrigerated storage
12
temperature and duration of refrigerated storage before consumption, have a direct
13
bearing on cold
14
establishments.
15
FDA continues to have concerns about the potential for growth of Lm in
16
refrigerated, ready-to-eat, potentially hazardous food (time/temperature control
17
for safety food), prepared and packaged in a food processing plant and held
18
in a food establishment.
19
Annex 3 3-501.16 Table 1) show a significant reduction in the projected cases
20
of listeriosis when refrigerated storage is limited to 41ºF.
21
data and conclusions from the risk assessment, FDA continues to recommend
22
that
holding
time/temperature
combinations used
in
food
Data from the risk assessment (see the following
Based on these
food establishments limit the cold storage of potentially hazardous
Guam Food Code Annex 1 – Public Health Reasons
148
1
(time/temperature
control
2
temperature of 41ºF.
for
safety),
ready-to-eat foods to a maximum
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
3-501.16 – Table 1. Estimated Reduction of Cases of Listeriosis from Limits
on Refrigeration Temperatures*
26
Regarding shell eggs, USDA published a final rule (63 FR 45663, August 27,
27
1998 Refrigeration and Labeling Requirements for Shell Eggs) to require that
28
shell eggs packed for consumer use be stored and transported at an ambient
29
temperature not to exceed 7ºC (45ºF). This regulation, however, does not apply
30
to eggs while held at all retail establishments. FDA is concerned that without
31
continued refrigeration up until the time that the eggs are cooked, there would
32
be an opportunity for the egg's defenses to degrade and growth of Salmonella
33
Enteritidis to occur. The agency reviewed research indicating that Salmonella
34
Enteritidis multiplies at temperatures of 10ºC (50ºF) and above but can be
35
inhibited at lower temperatures, e.g., 8ºC (46ºF), 7ºC (45ºF), and 4ºC (39ºF).
Cases of Listeriosisa
Maximum Refrigerator
Temperature
Baselineb
7 ˚C (45 ˚F) maximum
5 ˚C (41 ˚F) maximum
Median
2105
5th Percentile
3/4c
95th Percentile
3/4c
656
28
331
1
761
126
a
Values for the median, upper and lower uncertainty levels.
The baseline uses the full empirical distribution of refrigerator temperatures from the Audits
International (1999) survey.
c
The baseline number of cases of listeriosis is fixed based on CDC surveillance data.
*The scenario assumed the distribution of storage times is the same for all three temperature
sets.
Source: Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria
monocytogenes Among Selected Categories of Ready-to-Eat Foods September 2003. Table VI-1.
Estimated Reduction of Cases of Listeriosis from Limits on Refrigeration Temperatures.
b
Guam Food Code Annex 1 – Public Health Reasons
149
1
Based on this research and USDA's temperature requirement during transport,
2
FDA implemented regulations that establish a maximum ambient air temperature
3
of 7ºC (45ºF) for eggs stored and displayed at retail establishments. Amended
4
Federal regulations 21 CFR Part 115.50 issued on December 5, 2000 and
5
became effective on June 4, 2001.
6
Although Congress did not expressly preempt State law in this area, FDA found
7
preemption is needed because State and local laws that are less stringent
8
than the Federal requirements will not support the important public health
9
goals of these regulations.
FDA does not believe that preemption of State
10
and local refrigeration and labeling requirements that are the same as or
11
more stringent than the requirements of these regulations is necessary, as
12
enforcement of such State and local requirements will support the food safety
13
goals of these regulations. Accordingly, the preemptive effect of this rule is
14
limited to State or local requirements that are not as stringent as the
15
requirements of these regulations; requirements that are the same as or
16
more stringent than FDA's requirements remain in effect.
17
Hot Holding
18
In a January 2001 report, the National Advisory Committee on Microbiological
19
Criteria for Foods (NACMCF) recommended that the minimum hot holding
20
temperature specified in the Food Code:
21
22

Be greater than the upper limit of the range of temperatures at which
Clostridium perfringens and Bacillus cereus may grow; and
Guam Food Code Annex 1 – Public Health Reasons
150
1

Provide a margin of safety that accounts for variations in food
2
matrices, variations in temperature throughout a food product,
3
and the capability of hot holding equipment to consistently maintain
4
product at a desired target temperature.
5
C. perfringens has been reported to grow at temperatures up to 52°C
6
(126°F). Growth at this upper limit requires anaerobic conditions and follows
7
a lag phase of at least several hours. The literature shows that lag phase
8
duration and generation times are shorter at incubation temperatures below 49°C
9
(120°F) than at 52°C (125°F). Studies also suggest that temperatures that
10
preclude the growth of C. perfringens also preclude the growth of B. cereus.
11
CDC estimates that approximately 250,000 foodborne illness cases can be
12
attributed to C. perfringens and B. cereus each year in the United States.
13
These spore-forming pathogens have been implicated in foodborne illness
14
outbreaks associated with foods held at improper temperatures.
15
suggests that preventing the growth of these organisms in food by maintaining
16
adequate hot holding temperatures is an important public health intervention.
17
Taking into consideration the recommendations of NACMCF and the 2002
18
Conference for Food Protection meeting, FDA believes that maintaining food
19
at a temperature of 57°C (135°F) or greater during hot holding is sufficient to prevent
20
the growth of pathogens and is therefore an effective measure in the prevention of
21
foodborne illness.
22
23
3-501.17
Ready-to-Eat, Potentially Hazardous Food
(Time/Temperature Control for Safety Food),
Guam Food Code Annex 1 – Public Health Reasons
151
This
1
2
Date Marking.*
3-501.18
Ready-to-Eat, Potentially Hazardous Food
3
(Time/Temperature Control for Safety Food),
4
Disposition.*
5
Refer to Annex 7, Chart 4-C.
6
Refrigeration prevents food from becoming a hazard by significantly slowing the
7
growth of most microbes.
8
monocytogenes, is significantly slowed but not stopped by refrigeration. Over
9
a period of time, this and similar organisms may increase their risk to public
The growth of some bacteria, such as Listeria
10
health in ready-to-eat foods.
11
The date by which the food must be consumed takes into consideration the
12
differences in growth of Listeria monocytogenes at 5oC (41oF) and 7oC
13
(45oF).
14
monocytogenes, ready-to-eat, potentially hazardous food (time/temperature control
15
for safety food) may be kept at 5oC (41oF) a total of 7 days or at 7oC (45oF) a
16
total of 4 days.
17
shortened for food in refrigerators incapable of maintaining food at 5oC (41oF)
18
but capable of maintaining it at 7oC (45oF) or below. Food which is prepared
19
and held, or prepared, frozen, and thawed must be controlled by date
20
marking to ensure its safety based on the total amount of time it was held at
21
refrigeration temperature, and the opportunity for Listeria monocytogenes to
22
multiply, before freezing and after thawing. Potentially hazardous (time/temperature
Based on a predictive growth curve modeling program for Listeria
Therefore, the period of time allowed before consumption is
Guam Food Code Annex 1 – Public Health Reasons
152
1
control for safety) refrigerated foods must be consumed, sold or discarded by the
2
expiration date.
3
Date marking is the mechanism by which the Food Code requires active managerial
4
control of the temperature and time combinations for cold holding. Industry
5
must implement a system of identifying the date or day by which the food
6
must be consumed, sold, or discarded.
7
containers of processed food that have been opened and to food prepared by
8
a food establishment, in both cases if held for more than 24 hours, and
9
while the food is under the control of the food establishment. This provision
10
applies to both bulk and display containers. It is not the intent of the Food
11
Code to require date marking on the labels of consumer size packages.
12
A date marking system may be used which places information on the food, such
13
as on an overwrap or on the food container, which identifies the first day of
14
preparation, or alternatively, may identify the last day that the food may be
15
sold or consumed on the premises. A date marking system may use calendar
16
dates, days of the week, color-coded marks, or other effective means,
17
provided the system is disclosed to the Regulatory Authority upon request, during
18
inspections.
19
FDA/USDA/CDC Listeria monocytogenes Risk Assessment
20
In September, 2003, FDA, in cooperation with USDA/FSIS and CDC, released
21
the
22
Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat
23
Foods. This initiative included the development of 23 separate risk assessments
Quantitative
Assessment
Date marking requirements apply to
of the Relative Risk to Public Health from
Guam Food Code Annex 1 – Public Health Reasons
153
1
and analysis of the relative risks of serious illness and death associated with
2
consumption of 23 categories of ready-to-eat foods. These categories included:
3
seafood, produce, meats, dairy products, and deli salads.
4
In examining these closely, FDA showed that 5 factors are important in measuring
5
the public health impact to consumers from foodborne listeriosis. These factors
6
are: (1) amounts and frequency of consumption of a ready-to-eat food; (2)
7
frequency and levels of L. monocytogenes in a ready-to-eat food; (3) potential
8
of the food to support growth of the bacterium during refrigeration; (4) refrigerated
9
storage temperature; and (5) duration of refrigerated storage before consumption.
10
Based on these 5 factors, the 23 categories of ready-to-eat foods were ranked
11
according to their relative risk of contamination and growth of Listeria
12
monocytogenes. The risk categories used were: very high risk; high risk; moderate
13
risk; low risk; and very low risk.
14
Impact of the Listeria monocytogenes Risk Assessment on Date
15
Marking
16
Based on the results of the risk assessment and the recommendations
17
from the 2004 Conference for Food Protection meeting, it was necessary
18
to re-evaluate date marking in an effort to focus the provision on very
19
high and high risk foods, while at the same time, exempting foods that
20
present a very low, or low risk of contamination and growth of Listeria
21
monocytogenes. Based on this evaluation, date marking provisions of
22
the Food Code do not apply to the following foods:
23
Deli Salads Prepared and Packaged in a Food Processing Plant
Guam Food Code Annex 1 – Public Health Reasons
154
1
Examples of deli salads include ham salad, chicken salad, egg salad, seafood
2
salad, pasta salad,
3
according to 21 CFR 110. According to data from the risk assessment,
4
deli salads prepared and packaged by a food processing plant contain
5
sufficient acidity, along with the addition of preservatives (e.g., sorbate,
6
benzoates), to prevent the growth of Listeria monocytogenes. There are
7
estimates that 85% of all deli salads are prepared and packaged in a
8
food processing plant and do not support growth. Based on discussions
9
with deli salad manufacturers and trade associations, it is a nearly universal
10
practice for food processing plants preparing and packaging deli salads to add
11
one or more preservatives
12
monocytogenes. Based on their wide use within this segment of the industry
13
and their effectiveness at inhibiting
14
monocytogenes, all deli salads prepared and packaged in a food
15
processing plant are exempt from date marking. However, all deli salads
16
prepared in a food establishment require date marking.
17
Hard and Semi-Soft Cheeses
18
In December, 1999, FDA issued an exemption from date marking for
19
certain
20
(http://www.cfsan.fda.gov/~ear/ret-chdt.html), based on the presence of
21
several factors that may control the growth of Listeria monocytogenes.
22
These factors may include organic acids, preservatives, competing
23
microorganisms, pH, water activity, or salt concentration.
types
potato salad, and macaroni salad,
that
of
inhibit
hard
the
and
the
growth
growth
semi-soft
Guam Food Code Annex 1 – Public Health Reasons
155
manufactured
of
of
Listeria
Listeria
cheeses
The results of
1
the risk assessment support this interpretation and therefore, hard and
2
semi-soft cheeses each manufactured according to 21 CFR 133 are
3
exempt from date marking.
Guam Food Code Annex 1 – Public Health Reasons
156
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
List of Some Hard and Semi-Soft Cheeses Exempt from Datemarking
Asadero
Abertam
Appenzeller
Asiago medium or old
Bra
Cheddar
Cristalina
Colby
Cotija Anejo
Cotija
Coon
Derby
Emmentaler
English Dairy
Gex (blue veined)
Gloucester
Gjetost
Gruyere
Herve
Lapland
Lorraine
Oaxaca
Parmesan
Pecorino
Queso Anejo
Queso Chihuahua
Queso de Prensa
Romanello
Romano
Reggiano
Sapsago
Sassenage (blue veined)
Stilton (blue veined)
Swiss
Tignard (blue veined)
Vize
Wensleydale (blue veined)
Asiago soft
Battelmatt
Bellelay (blue veined)
Blue
Brick
Camosum
Chantelle
Edam
Fontina
Gorgonzola (blue veined)
Gouda
Havarti
Konigskase
Limburger
Milano
Manchego
Monterey
Muenster
Oka
Port du Salut
Provolone
Queso de Bola
Queso de la Tierra
Robbiole
Roquefort (blue veined)
Samsoe
Tilsiter
Trappist
39
Cultured Dairy Products
40
Cultured dairy products include yogurt, sour cream, and buttermilk, each
41
manufactured according to 21 CFR 131. Many of these products often are
Guam Food Code Annex 1 – Public Health Reasons
157
1
low pH foods manufactured with lactic acid fermentation. Data from the risk
2
assessment show that Listeria monocytogenes does not grow in these
3
foods and therefore, these products are exempt from date marking.
4
Preserved Fish Products
5
Preserved fish products include pickled herring and dried, or salted cod,
6
and other acidified fish products, manufactured according to 21 CFR 114.
7
Data from the risk assessment show that the high salt and/or acidity of
8
these products does not allow for the growth of Listeria monocytogenes
9
and therefore,
these products are exempt from date marking. This
10
exemption does not apply to hot or cold smoked fish products, nor does it
11
apply to fish products that are dried, marinated, or otherwise preserved on-
12
site, in a food establishment, such as ceviche.
13
USDA-regulated products
14
Date marking provisions of the Food Code do not apply to shelf stable ready-
15
to-eat meat and poultry products. Shelf stable ready-to-eat meat and poultry
16
products are not required by USDA to be labeled “Keep Refrigerated.” For
17
these products, the nitrite and salt in the cure and the lower pH resulting from
18
fermentation give additional protection against microbial growth. Some fermented
19
sausages and salt-cured products are shelf stable, do not require refrigeration,
20
and do not bear the label “Keep Refrigerated.” To be shelf stable, a product
21
manufactured under USDA inspection must have a process that results in a
22
product that meets one of the recognized objective criteria for shelf stability,
23
such as water activity, moisture-protein ratio (MPR), or combination of MPR and
Guam Food Code Annex 1 – Public Health Reasons
158
1
pH (acidity). Therefore they are exempt from the Food Code date marking
2
requirements.
3
Shelf stable fermented sausages such as pepperoni and dry salami do not
4
have to be refrigerated or date marked. Shelf stable salt-cured products such
5
as prosciutto, country cured ham, or Parma ham do not require refrigeration or
6
Food Code date marking. Other salt-cured products include basturma, breasaola,
7
coppa, and capocolla.
8
Some ready-to-eat fermented sausages and salt-cured products must be
9
refrigerated and therefore bear the USDA-required label “Keep Refrigerated.”
10
Examples of these products are cooked bologna, cooked salami, and sliced
11
country
12
refrigeration. Bologna is a cooked, perishable sausage and there are other
13
salamis, e.g., cotto that are perishable.
14
Regarding the exemption from date marking for shelf-stable sausages in a casing,
15
the exemption does not apply if the casing is removed. The intact casing on
16
shelf-stable sausages may be overwrapped to protect the cut face of the
17
sausage. With shelf stable (not potentially hazardous (time/temperature control
18
safety)) sausages, the intact casing provides a barrier to contamination (although
19
not an absolute one), the exposed face is likely to be sliced again within 4 or 7
20
days, and contamination is minimized because only the face is exposed. The
21
coagulated protein that occurs on the surface of some nonshelf stable
22
cooked sausages is not a casing.
ham which
are ready-to-eat
fermented
products
Guam Food Code Annex 1 – Public Health Reasons
159
that
need
1
Slices of cured and fermented sausages that require refrigeration and are kept
2
for 24 hours or longer do need to be date marked.
3
If open dating information is applied to lunchmeats at a federally inspected
4
meat
5
requirements in 9 CFR 317.8 and 381.129.
6
required by USDA/FSIS and if applied, would not supercede or replace date marking
7
requirements established by the Food Code or by State/local authorities that
8
apply after the food is opened in a retail establishment.
9
Manufacturer’s use-by dates
or
poultry
establishment,
the
information must comply with the
However, such dating is not
10
It is not the intent of
this provision to give a product an extended shelf life
11
beyond that intended by the
12
products for various reasons, and spoilage may or may not occur before
13
pathogen growth renders the product unsafe. Most, but not all, sell-by or use-
14
by dates are voluntarily placed on food packages.
15
Although most use-by and sell-by dates are not enforceable by regulators, the
16
manufacturer's use-by date is its recommendation for using the product while
17
its quality is at its best. Although it is a guide for quality, it could be based on
18
food safety reasons. It is recommended that food establishments consider
19
the manufacturer’s information as good guidance to follow to maintain the
20
quality (taste, smell, and appearance) and salability of the product.
21
product becomes inferior quality-wise due to time in storage, it is possible
22
that safety concerns are not far behind.
23
It is not the intention of this provision that either the manufacturer’s date or
manufacturer. Manufacturers assign a date to
Guam Food Code Annex 1 – Public Health Reasons
160
If the
1
the
2
packages.
3
date marked by the food establishment be placed on consumer
3-501.19
Using Time as a Public Health Control.*
4
The 2000 Conference for Food Protection (CFP) meeting recommended that FDA
5
ask the National Advisory Committee on Microbiological Criteria for Foods
6
(NACMCF) to review the Food Code provision that addresses using time
7
alone as a public health control, section 3-501.19. In response to the CFP
8
recommendation, FDA in consultation with USDA/FSIS, determined that there
9
is sufficient scientific information available to support the current provision in the
10
Food Code without requesting consideration by the NACMCF. As an alternative
11
response, FDA informed the CFP that it would provide the following position
12
paper on using time alone as a public health control.
13
Position Paper
14
Food
15
(time/temperature control for safety) food that is ready-to-eat (RTE) to be
16
stored without temperature control for up to 4 hours, after which it must be discarded
17
or consumed or for up to 6 hours for refrigerated food, if the food is 5°C
18
(41°F) when initially removed from temperature control, and as long as the
19
food temperature does not exceed 21°C (70°F). The following information is
20
provided to explain the reasoning in allowing time alone to be used as a public
21
health control for food safety.
22
Background information
23
Food kept without temperature control allows product to warm or cool as it
Code
section
3-501.19
allows
potentially
Guam Food Code Annex 1 – Public Health Reasons
161
hazardous food
1
equilibrates with the environment. Each temperature scenario incurs different
2
risks in regard to the type of foodborne pathogens able to grow and the rate of
3
growth likely to occur.
4
depends on the amount of time the food spends in an optimum growth temperature
5
range during its equilibration with its surroundings. Several factors influence
6
the rate of temperature change in a food, such as the type of food, thickness
7
of
8
surroundings. When evaluating the safety of a 4-hour limit for food with no
9
temperature control, products and environmental parameters must be selected
the
food,
and
For both cooling and warming conditions, growth
temperature
differential
between
the
food and
its
10
to create a worst-case
scenario for pathogens growth and possible toxin
11
production.
12
Holding Cold Food Without Temperature Control
13
When a food is removed from refrigerated storage and begins to warm to
14
room temperature, Listeria monocytogenes is a primary organism of concern.
15
Even while food is held at refrigeration temperatures, the growth potential of L.
16
monocytogenes warrants concern for potentially hazardous (time/temperature
17
control for safety foods) RTE foods. Although the FDA and USDA have a
18
zero tolerance for L. monocytogenes in RTE food, conditions are permitted in
19
the Food Code that would allow L. monocytogenes cells 1 log of growth (3.3
20
generations). Salmonella is also a concern especially with products containing
21
eggs. However, L. monocytogenes grows more rapidly than Salmonella at
22
refrigeration and room temperatures. By ensuring minimal Listeria growth in food,
23
the threat from Salmonella would be negligible. Warming conditions will allow
Guam Food Code Annex 1 – Public Health Reasons
162
1
food to remain exposed to temperatures that allow B. cereus to produce
2
emetic toxin. However, the 4-hour time constraint in the Food Code is sufficient
3
to prevent any toxin formation.
4
For
5
temperature of 75°F for 4 hours, the growth rate of L. monocytogenes remains
6
slow enough to ensure that the critical limit of 1 log growth is not reached.
7
Published generation times at 75°F for L. monocytogenes in food were not
8
found, however published values at 68ºF and 70°F in egg and milk products
9
confirmed slow L. monocytogenes growth at room temperatures.
food
refrigerated
at
41ºF
or
45°F
then transferred to an ambient
10
Using the USDA Pathogen Modeling Program (PMP) and assuming the optimum
11
conditions of pH 6.8, 0.5% NaCl, 0.0% nitrite, L. monocytogenes would require
12
more than 4 hours to grow 1 log at 75°F. The PMP is based on broth studies and
13
not on food products. Therefore, the growth rates reported at various
14
temperatures by the PMP are faster than growth rates in most food products.
15
Another factor exaggerating the growth rate in this warming scenario as
16
predicted by the PMP is the assumption that the food product spent all 4
17
hours at 75°F. Obviously food equilibrates with the surrounding environment
18
at a gradual rate and would not equilibrate instantly.
19
Unfortunately there are no models that take changing temperatures into
20
consideration when predicting growth. Likewise there are very few published papers
21
dealing with the growth of organisms in food during warming. The conservative
22
nature of the 4-hour limit for keeping foods without temperature control allows for
23
a needed margin of safety if the temperature of the environment is higher than
Guam Food Code Annex 1 – Public Health Reasons
163
1
75°F.
2
It is important to note that potentially hazardous (time/temperature control for
3
safety) foods held without cold holding temperature control for a period of 4 hours
4
do not have any temperature control or monitoring. These foods can reach any
5
temperature when held at ambient air temperatures as long
6
discarded or consumed within the four hours.
7
Holding Hot Food without Temperature Control
8
The second scenario for food without temperature control exists when food is
9
cooked according to Food Code recommendations, then kept at room temperature
as they are
10
for 4 hours before discarding.
Foodborne pathogens of concern for
11
uncontrolled
12
perfringens and Bacillus cereus.
13
guidelines should be free of vegetative cells. However, the heat requirements are
14
not sufficient to kill spores of C. perfringens or B. cereus and may actually
15
serve as a heat shock that activates the spores. B. cereus is found commonly
16
in outbreaks attributed to inadequate hot holding of starchy foods like rice, and
17
has been isolated in a multitude of food products. C. perfringens is found
18
commonly in outbreaks attributed to inadequate hot holding of beef and poultry.
19
Despite the prevalence of both spores in nature, C. perfringens cases are
20
estimated to be more numerous than B. cereus cases by a factor of 10.
21
B. cereus can produce emetic toxin in food, and the optimum temperature for
22
the production of toxin is between 77°F and 86°F. However, the time needed
23
to produce the toxin is longer than the time the food will be exposed to any
temperature scenario
are sporeformers including Clostridium
Food cooked according to Food Code
Guam Food Code Annex 1 – Public Health Reasons
164
an
1
temperature range with a 4-hour holding limit. Both C. perfringens and B. cereus
2
produce enterotoxin inside the intestine of the infected host if substantial
3
numbers of vegetative cells are present in the food (105-7 CFU/g). Although the
4
reported levels of both spores in raw foods vary in the literature, generally the level
5
expected in food can be assumed to be low (around 10-1000 CFU/g). This
6
implies that conditions allowing 1 log growth of either spore could be tolerated
7
in food.
8
During the time without temperature control, the temperature of the food could
9
decrease slowly enough to expose spores of both organisms to optimal growth
10
conditions for a significant length of time. Like warming, several variables exist that
11
determine the rate of heat transfer. Because of the wide variety of foods prepared it
12
would be impossible to generalize how fast a typical product loses temperature after
13
cooking. As with warming, it is prudent to imagine a worst-case scenario where
14
heat loss is slowed. A beef roast slow cooked to 130°F for the appropriate
15
time according to the Food Code was used as consideration for possible
16
spore
17
environment in both the meat and gravy. The low internal temperature creates
18
a small temperature differential with the environment (assumed
19
allowing
20
After evaluating published studies as well as data collected at the FDA, the
21
surface of a roast beef or rolled meat product would lose heat quickly
22
enough to discourage significant growth of either C. perfringens or B. cereus.
23
If all spores were distributed on the surface of the product by either pre- or
growth.
Cooking
roast
beef to 130°F can create
an
anaerobic
at 75°F),
for a slower decrease in the food’s temperature.
Guam Food Code Annex 1 – Public Health Reasons
165
1
post-cooking contamination, storing this product for 4 hours at room conditions
2
would be considered safe. Likewise, products that are stirred or products that
3
lose heat faster than a roast would also be considered safe.
4
FDA intends to do research regarding food products that may have spores in
5
the center of the product, and further evaluate if there are potential hazards
6
that may be associated with them while held without temperature control for 4
7
hours.
8
9
----------- End of position paper ---------
10
11
At the 2004 meeting of the CFP, a committee submitted and the Conference
12
accepted a document that examined scientific research related to the growth of
13
Listeria monocytogenes, and
the influence of time and temperature on its
14
growth.
committee
15
http://www.foodprotect.org/doc/04_issues/folder_attachments/III-008a%finalreport-
16
timeasapublichealthcontrol.pdf.
17
The 2004 CFP report stated that the USDA-PMP program can be used as a
18
tool to estimate time periods for a 1-log increase in growth for Listeria
19
monocytogenes
20
modeling approach, at 41°F, 45°F, and 50°F, the time for a 1-log increase
21
was, 87.8, 53.9, and 34.7 hours, respectively. At room temperature (70°F) a 1-
22
log increase was noted at
23
(95°F), the reported time for a 1-log increase was 3.0 hours. In general, the
The
CFP
report
is
in ideal (laboratory media) growth conditions.
found
at
Using this
5.2 hours and at ideal growth temperatures
Guam Food Code Annex 1 – Public Health Reasons
166
1
data from the USDA-PMP program provides very conservative growth data
2
and, in most cases, growth would be expected to be less rapid in a food
3
system. This table does provide comparative information relative to growth rates
4
at different holding temperatures in the event that time was used as a factor
5
in managing food safely.
6
The report further recommended that food could safely be held for up to 6
7
hours without external temperature control as long as the food temperature
8
did not
exceed 70F.
Based on that report and data from the Quantitative
9
Assessment of the Relative Risk to Public Health from Foodborne Listeria
10
monocytogenes Among Selected Categories of Ready-to-Eat Foods September
11
2003, the Food Code allows potentially hazardous food (time/temperature control
12
for safety) food to be stored up to 6 hours without external temperature control
13
provided that the food temperature does not exceed 70F and the food is
14
discarded or consumed at the end of the 6 hours.
15
Raw eggs
16
Recipes in which more than one egg is combined carry an increased risk of illness
17
and possible serious consequences for certain people. It is due to this increased
18
risk, and documented occurrences of foodborne illness and death among highly
19
susceptible populations from temperature-abused raw shell eggs contaminated
20
with Salmonella Enteritidis, that the use of time as a public health control in
21
institutional settings is not allowed.
22
Specialized
23
Processing
3-502.11
Variance Requirement.*
Guam Food Code Annex 1 – Public Health Reasons
167
1
Methods
2
Specific food processes that require a variance have historically resulted in
3
more foodborne illness than standard processes. They present a significant health
4
risk if not conducted under strict operational procedures. These types of
5
operations may require the person in charge and food employees to use specialized
6
equipment and demonstrate specific competencies. The variance requirement is
7
designed to ensure that the proposed method of operation is carried out safely.
8
The concept of variances may be new to some regulatory authorities. Some
9
jurisdictions may not have a formal process to respond to industry requests for
10
variances, although informal allowances may have been allowed in specific
11
situations. Recognizing the opportunity to use the variance process may
12
require additional rulemaking, or at least policy development, at the jurisdictional
13
level. Rulemaking can be used to outline the procedures for a variance request,
14
including the information required in section 8-103.11. In addition, the rulemaking
15
process can address the regulatory
16
industry’s variance application and an appeals process in case a variance is not
17
given due consideration or is denied. The Conference for Food Protection Variance
18
Committee recommended that regulatory agencies adopt a variance
19
process. General guidance regarding administrative procedures is given below.
20
Regulatory authorities considering implementing variances have encountered
21
issues relating to their authority or technical, scientific ability to evaluate or validate
22
a variance request.
23
complex issues and scientific competencies beyond the ability of the regulatory
authority’s responsibility to consider an
review
From any variance request there may emerge a set of
Guam Food Code Annex 1 – Public Health Reasons
168
1
authority to validate. The Conference for Food Protection Variance Committee
2
recommended that rulemaking should reflect a multi-level matrix of regulatory
3
agencies ranging from local regulatory authorities through FDA and reflected that
4
recommendation
5
encouraged to seek input and guidance from authoritative sources such as
6
processing authorities, professional associations, or academia. Within the
7
Variance Committee's model, the process for seeking FDA advice begins with
8
the Regional Food Specialists.
9
Except for the Interstate Travel Program, FDA generally does not directly
10
regulate retail and food service establishments, including entertaining variances
11
for that segment of the industry. FDA is still exploring processes for handling
12
variances
13
businesses. In conjunction with the 2000 CFP Variance Committee, FDA will
14
continue to explore ways to provide assistance and guidance to regulators
15
regarding access to scientific and technical resources in order to make
16
science-based decisions regarding variances.
17
FDA recommends that regulatory authorities develop a written administrative
18
process that is consistent with, and addresses the information contained in,
19
Food Code sections 8-103.10, 8-103.11, and 8-103.12, and follow a process
20
consistent with the recommendations of the CFP Variance Committee as shown
21
in its flow chart.
in
the
following flow chart.
The regulatory authority
is
on a national basis such as those received from national chain
Guam Food Code Annex 1 – Public Health Reasons
169
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
3-501.11 Chart 1 – A Model Flow Process for State Regulators to Address Variances
Developed by the CFP Variance Committee
Multi-state
issue or
food in
interstate
commerce
FDA
Regional
Food
Specialist
(RFS)
In-state
issue or
intrastate
commerce
Review by
state, local,
or tribal
Regulatory
Authority
(RA)
Referral to
FDA/CFSAN
by RFS, if
needed
Does RA have
technical
ability to make
a decision?
Yes
Disseminate
information
to interested
parties
FDA makes
recommendation
Notify RFS
of RA
decision
RA makes
variance
decision
No
Further
evaluation
required –
refer to
FDA/RFS
Guam Food Code Annex 1 – Public Health Reasons
170
Disseminate
information
to interested
parties
FDA makes
recommendation
Model Administrative Procedures for Regulators to Address Variances
1
2
1)
Designate an agency team and assign a leader to address variance requests.
3
2)
Establish an agency review process leading to approval or denial of variance
4
applications.
5
consulting with food processing authorities, food scientists, academia,
6
professional organizations, other government agencies including the FDA
7
Regional Food Specialist, or other experts external to the agency.
8
3)
9
For food safety issues, include recommendations for
Set reasonable timelines for decision making.
Determine of the variance
application addresses an intrastate or interstate issue.
10
a)
For variances that have interstate or national implications, especially
11
those that address food safety, regulators are urged to contact and work
12
closely with their FDA Regional Food Specialist to determine if a
13
national policy related to the issue exists. Regulators are encouraged to
14
be consistent with national policies, guidelines, or opinions.
15
b)
For variances that address intrastate issues, regulators are also
16
encouraged to determine if other State or national guidance exists,
17
and to stay consistent with it.
18
4)
19
Make the agency’s decision. Inform the applicant.
a)
20
document all special provisions with which the applicant must comply.
21
b)
22
23
If the variance request is approved, determine the starting date and
If the variance request is denied, inform the applicant as to the reasons for
the denial, the applicant's right to appeal, and the appeal process.
5)
Inform other interested parties, including the FDA Regional Food Specialist.
Guam Food Code Annex 1 – Public Health Reasons
171
1
a)
For variances having interstate or national implications, especially those
2
that address food safety, regulators are urged to inform their FDA
3
Regional
4
appropriately disseminate the information regarding food safety variances
5
that may affect food establishments in other jurisdictions, such as
6
national chains.
7
b)
8
9
Food Specialist
so
that
FDA
is
aware of, and
can
For variances that address intrastate issues, regulators are encouraged to
share the information as if it were an interstate issue.
6)
Document all agency actions and decisions in the facility’s file. Consider
10
including documentation of special variance provisions on the establishment's
11
permit to operate.
12
7)
If the variance is approved, inform the inspector assigned to that facility
13
and train the inspector on the variance provisions, including the implementation
14
of the industry’s HACCP plan, if required.
15
8)
Establish procedures to periodically review the status of the variance,
16
determine if it successfully accomplishes its public health objective, and ensure
17
that a health hazard or nuisance does not result from its implementation.
18
19
20
9)
Establish written procedures for withdrawing approval of the variance if it is
not successful.
3-502.12
Reduced Oxygen Packaging, Criteria.*
21
Reduced oxygen packaging (ROP) encompasses a large variety of packaging
22
methods where the internal environment of the package contains less than the
23
normal ambient oxygen level (typically 21% at sea level), including vacuum
Guam Food Code Annex 1 – Public Health Reasons
172
1
packaging (VP), modified atmosphere packaging (MAP), controlled atmosphere
2
packaging (CAP), cook chill processing (CC), and sous vide (SV). Using ROP
3
methods in food establishments has the advantage of providing extended shelf
4
life to many foods because it inhibits spoilage organisms that are typically
5
aerobic.
6
This state of reduced oxygen is achieved in different ways. Oxygen can be
7
withdrawn from the package (VP) with or without having another gas such as
8
nitrogen or carbon dioxide replacing it (MAP). Fresh produce and raw meat or
9
poultry continue to respire and use oxygen after they are packaged. Bacterial
10
activity also plays a role here.
11
transmission of oxygen is usually designated by an Oxygen Transfer Rate of 10,000
12
cm2/m3/24 hours or greater. A reduced oxygen atmosphere will result with an
13
Oxygen Transmission rate of 10-100. The process of cooking drives off oxygen
14
(the bubbling is oxygen gas coming off) and leaves a reduced oxygen level in the
15
food, thus, microenvironments of reduced oxygen are possible even without
16
packaging that has a barrier to oxygen transmission.
17
Most foodborne pathogens are anaerobes or facultative anaerobes able to multiply
18
under either aerobic or anaerobic conditions, therefore special controls are
19
necessary to control their growth. Refrigerated storage temperatures of 5°C
20
(41°F) may be adequate to prevent growth and/or toxin production of some
21
pathogenic
22
monocytogenes are able to multiply well below 5°C (41°F). For this reason,
23
C. botulinum and L. monocytogenes become the pathogens of concern for
microorganisms
but
Packaging material that readily allow the
non-proteolytic
C.
Guam Food Code Annex 1 – Public Health Reasons
173
botulinum
and
L.
1
ROP.
Controlling
their growth will
control the growth of other foodborne
2
pathogens as well.
3
The control of C. botulinum or L. monocytogenes when using ROP is usually
4
accomplished using multiple hurdles or barriers to growth. Subparagraph 3-
5
502.12(B)(2) identifies secondary barriers that will control the growth
6
botulinum
7
storage
8
of 4.6 or
9
substances
of
C.
and L. monocytogenes when used in conjunction with a food
temperature of 5°C (41°F) or less. They include aw of 0.91 or less; pH
less;
cured,
USDA
inspected
specified in 9 CFR 424.21;
meat or poultry products
using
or high levels of competing
10
microorganisms. C. botulinum will not produce toxin below an aw of 0.91. Nitrite,
11
used in meat and poultry curing, inhibits the outgrowth of C. botulinum spores.
12
Most foodborne pathogens do not
13
therefore foods that have a high level of spoilage organisms or lactic acid
14
bacteria can safely be packaged using ROP.
15
Naturally fermented cheeses, as identified in ¶ 3-502.12(E), that meet the Standards
16
of Identity for hard, pasteurized process, and semisoft cheeses in 21 CFR
17
133.150, 21 CFR 133.169, or 21 CFR 133.187, respectively, contain various
18
intrinsic factors, often acting synergistically, that together act as a secondary
19
barrier to pathogen growth along with refrigerated storage at 5°C (41°F) or less.
20
This combination of factors could include some or all of the following: a lower pH,
21
production of organic acids, and natural antibiotics or bacteriocins such as nisin by
22
lactic acid bacteria, salt (NaCl) added during processing, low moisture content,
23
added preservatives, and live competing cultures.
compete well with other microorganisms,
Very few outbreaks have
Guam Food Code Annex 1 – Public Health Reasons
174
1
occurred that were associated with cheese. The few outbreaks of foodborne illness
2
associated with cheeses or cheese products could be traced in large part to
3
temperature abuse with storage at uncontrolled ambient air temperatures.
4
Examples of cheeses that may be packaged under ROP include Asiago medium,
5
Asiago old, Cheddar, Colby, Emmentaler, Gruyere, Parmesan, Reggiano, Romano,
6
Sapsago, Swiss, pasteurized process cheese, Asiago fresh and soft, Blue, Brick,
7
Edam, Gorgonzola, Gouda, Limburger, Monterey, Monterey Jack, Muenster,
8
Provolone, and Roquefort. Soft cheeses such as Brie, Camembert, Cottage, and
9
Ricotta may not be packaged under reduced oxygen because of their ability to
10
support the growth of L. monocytogenes under modified atmosphere conditions.
11
12
When the food to be packaged under reduced oxygen conditions cannot reliably
13
depend on secondary barriers such as aw, pH, nitrite in cured meat products,
14
high levels of competing microorganisms or intrinsic factors in certain cheeses,
15
time/temperature
16
botulinum and L. monocytogenes. In ¶ 3-502.12(D), cook-chill processing where
17
food is cooked then sealed in a barrier bag while still hot and sous vide processing
18
where food is sealed in a barrier bag and then cooked, both depend on
19
time/temperature alone as the only barrier to pathogenic growth. Therefore,
20
monitoring critical limits including those established for cooking to destroy
21
vegetative cells, cooling to prevent outgrowth of spores/toxin production, and
22
maintaining cold storage temperatures of 1°C (34°F) or less to inhibit growth
23
and/or toxin production of any surviving pathogens is essential. Since there are
becomes
the
critical
controlling factor
Guam Food Code Annex 1 – Public Health Reasons
175
for growth of C.
1
no other controlling factors for C. botulinum and L. monocytogenes in a cook-
2
chill or sous vide packaging system, temperature control must be continuously
3
monitored electronically and visually examined twice daily to verify that
4
refrigeration temperatures are adequate.
5
New technology makes it relatively easy to continuously and electronically monitor
6
temperatures of refrigeration equipment used to hold cook chill and sous vide
7
products at 1°C (34°F) or less. Thermocouple data loggers can connect directly
8
with commonly available thermocouple probes. Recording charts are also
9
commonly used. Temperature monitors and alarm systems will activate an alarm
10
or dialer if temperatures rise above preset limits. Nickel-sized data loggers are
11
available to record temperatures which can be displayed using computer
12
software. Since surveys have shown that temperature control in home kitchens
13
is not always adequate, food packaged using cook chill or sous vide processing
14
methods cannot be distributed outside the control of the food establishment
15
doing the packaging.
16
Time is also a factor that must be considered in ROP. The 14 day “use by” date
17
is required label information for VP, MAP, and CAP products and cannot exceed
18
the manufacturer’s “sell by” or “use by” date.
19
period because two barriers to growth are required to be present. When these
20
ROP products are frozen, there is no longer a restricted 14 day shelf life. The 30
21
day shelf life for cook chill and sous vide is based on killing all vegetative cells
22
in the cooking process, preventing recontamination, and then refrigerating at 34°F
23
or less with stringent temperature monitoring and recording requirements. These
This is considered a safe time
Guam Food Code Annex 1 – Public Health Reasons
176
1
criteria allow both institutional-sized cook chill operations that may feed thousands
2
daily, often including transportation to their satellite locations, and individual
3
restaurants without ice banks and tumble or blast chillers to safely use cook
4
chill processes.
5
The extended shelf life for vacuum packaged hard and semisoft cheeses is based
6
on many intrinsic factors in these cheeses plus the normal
7
temperature of 41°F or less to maintain safety.
8
A Hazard Analysis Critical Control Point (HACCP) plan is essential when using
9
ROP processing procedures. C. botulinum and L. monocytogenes are potential
10
hazards which must be controlled in most foods unless the food is a low acid
11
canned food produced under 21 CFR Part 108 or 113 or an acidified food produced
12
under 21 CFR 114. Critical control points, critical limits, monitoring, record keeping,
13
corrective actions, and verification procedures will vary based on the type of
14
food and type of ROP technology used.
15
When a food establishment intends to use ROP technology but does not use
16
one of the secondary barriers defined in section 3-502.12 (a single barrier of
17
34°F combined with the criteria specified in paragraph 3-502.12(D), or hard or
18
semisoft cheeses manufactured using Standards of Identity for those cheeses),
19
the operator must submit an application for a variance under 3-502.11
20
providing evidence that the ROP methodology intended for use is safe.
21
Unfrozen raw fish and other seafood are specifically excluded from ROP because
22
of these products’ natural association with C. botulinum type E which grows
Guam Food Code Annex 1 – Public Health Reasons
177
refrigeration
1
at or above 3oC (37-38oF). Fish and seafood that are frozen before, during
2
and after the ROP packaging process are allowed.
3
Accurate
3-601.11
Standards of Identity.
4
Representation
3-601.12
Honestly Presented.
5
Labeling
3-602.11
Food Labels.
3-602.12
Other Forms of Information.
6
7
The identity of a food in terms of origin and composition is important for instances
8
when a food may be implicated in a foodborne illness and for nutritional
9
information requirements. Ingredient information is needed by consumers who
10
have allergies to certain food or ingredients. The appearance of a food should
11
not be altered or disguised because it is a cue to the consumer of the food's
12
identity and condition.
13
Recent illnesses and deaths from Shiga toxin-producing Escherichia coli have
14
occurred across the United States as a result of people eating hamburgers that
15
were contaminated and then undercooked. USDA issued final rules on August
16
8, 1994 requiring all raw meat or poultry products have a safe-handling label
17
or sticker or be accompanied by a leaflet that contains information on proper
18
handling and cooking procedures.
19
Certain requirements in the CFR relating to aspects of nutrition labeling
20
became effective in May, 1997. The following attempts to provide guidance
21
regarding those requirements and exemptions as they relate to the retail
22
environment and to alert regulators to authority that has been given to them
23
by the Nutrition Labeling and Education Act (NLEA) of 1990. The statute
Guam Food Code Annex 1 – Public Health Reasons
178
1
and the CFR should be reviewed to ensure a comprehensive understanding of the
2
labeling requirements.
3
I.
The following foods need not comply with nutrition labeling in the CFR
4
referenced in subparagraph 3-602.11(B)(5) if they do not bear a
5
nutrient claim, health claim, or other nutrition information:
6
(A)
7
Foods packaged in a food establishment if:
(1)
The food establishment has total annual sales to consumers of
8
no more than $500,000 (or no more than $50,000 in food
9
sales alone), and
10
(2)
11
12
The label of the food does not bear a reference to the
manufacturer or processor other than the food establishment;
(B)
13
Low-volume food products if:
(1)
The annual sales are less than 100,000 units for which a
14
notification claiming exemption has been filed with FDA's Office
15
of Nutritional Products Labeling and Dietary Supplements Food
16
Labeling by a small business with less than 100 full-time
17
equivalent employees, or
18
(2)
19
20
The annual sales are less than 10,000 units by a small
business with less than 10 full-time equivalent employees;
(C)
Foods served in food establishments with facilities for immediate
21
consumption such as restaurants, cafeterias, and mobile food
22
establishments, and foods sold only in those establishments;
Guam Food Code Annex 1 – Public Health Reasons
179
1
(D)
Foods similar to those specified in the preceding bullet but that
2
are sold by food establishments without facilities for immediate
3
consumption such as bakeries and grocery stores if the food is:
4
(1)
5
Ready-to-eat
but
not
necessarily
for immediate
consumption,
6
(2)
7
Prepared primarily in the food establishment from which it
is sold, and
8
(3)
Not offered for sale outside the food establishment;
9
(E)
Foods of no nutritional significance such as coffee;
10
(F)
Bulk food for further manufacturing or repacking; and
11
(G)
Raw fruits, vegetables, and fish.
12
II.
Game animal meats shall provide nutrition information which may
13
be provided by labeling displayed at the point of purchase such as
14
on a counter card, sign, tag affixed to the food, or some other
15
appropriate device.
16
III.
Food packaged in a food processing plant or another food
17
establishment, shall meet the requirements specified in § 3-602.11
18
and enforcement by the regulatory authority is authorized in the
19
NLEA, Section 4. State Enforcement.
20
In 1998,
21
CFR
Part
73, Section 73.75
was
21
canthaxanthin
22
Regulatory Fish Encyclopedia, the family Salmonidae includes pink salmon, coho
23
salmon, sockeye salmon, chinook salmon, Atlantic salmon, chum salmon,
as a color additive for salmonid fish.
amended to address
According to the FDA
Guam Food Code Annex 1 – Public Health Reasons
180
1
rainbow trout, cutthroat trout, and brown trout. This color additive may be in
2
the feed that is fed to aquacultured fish, and when those fish are placed into a
3
bulk container for shipment, the bulk container must bear a label declaring the
4
presence of canthaxanthin. That same label information must be displayed at
5
retail when those fish are offered for sale.
6
The 21 CFR Section 73.75(d)(4) requires that the presence of the color additive
7
in salmonid fish that have been fed feeds containing canthaxanthin be declared in
8
accordance with 21 CFR 101.22(b), (c), and (k)(2) and 101.100(a)(2). For
9
additional information, see the Federal Register announcement 63 FR 14814,
10
March 27, 1998,
Listing
of
Color
Additives
Exempt
from
Certification;
11
Canthaxanthin.
12
On August 2, 2004, President Bush signed into law the Food Allergen Labeling
13
and Consumer Protection Act of 2004 (Public Law 108-282). This new law
14
amended Sections 201 and 403 of the Federal Food, Drug, and Cosmetic Act to
15
establish food allergen labeling requirements for all packaged foods regulated
16
by FDA.
17
labeled on or after January 1, 2006 must identify on the label the names of
18
the food sources of any major food allergens (i.e., the following eight foods and any
19
protein derived from them: milk, egg, fish, crustacean shellfish, tree nuts, wheat,
20
peanuts, and soybeans) used as ingredients in the food. The names of the
21
food sources are the same as the names of the eight foods that are major
22
food allergens, with the exception that for fish, crustacean shellfish, and tree
23
nuts, their respective food source names are the specific species of fish
The new provisions require that all affected packages of food
Guam Food Code Annex 1 – Public Health Reasons
181
1
(e.g., bass, flounder, or cod), the specific species of crustacean shellfish (e.g.,
2
crab, lobster, or shrimp), and the specific types of tree nuts (e.g., almonds,
3
pecans, or walnuts).
4
Consumer
5
Advisory
6
Refer to the public health reason for § 3-401.11.
7
Purpose:
8
At issue is the role of government agencies, the regulated industry, and others
9
in providing notice to consumers that animal-derived foods that are not
10
subjected to adequate heat treatment pose a risk because they may contain
11
biological agents that cause foodborne disease. The deliverance of a balanced
12
message that communicates fairly to all consumers and, where epidemiologically
13
supported, attempts to place risk in perspective based on the consumer's
14
health status and the food being consumed is part of the challenge. Notification
15
of risk must be achieved via a meaningful message and in a manner that is
16
likely to affect behavior. The following information is to alert the reader to the
17
options available to food establishments in advising consumers of the increased
18
possibility of foodborne illness when animal-derived foods are eaten raw or
19
undercooked.
20
Background:
21
Although no specific advisory language was recommended, beginning with the
22
1993 Food Code, FDA included a codified provision for a point-of-purchase
23
consumer advisory and stated in Annex 3:
3-603.11
Consumption of Raw or Undercooked Animal
Foods.*
Guam Food Code Annex 1 – Public Health Reasons
182
1
“FDA has requested comments and will consider the responses as well
2
as other information that is available related to the risks involved and
3
methods of risk communication to determine what action may be necessary by
4
FDA to effectively inform consumers.”
5
Consumer Focus Groups:
6
During 1996 - 1998, FDA conducted two different consumer focus group
7
studies. Because the first set of focus groups (conducted before the 1997 Code)
8
were not receptive to the language recommended at the 1996 Conference for
9
Food Protection (CFP) meeting, that language was not included in the 1997
10
Code. Before the 1998 CFP meeting, the Agency convened a second set of
11
focus groups with a modified approach. The latter set expressed similar
12
thoughts as those in the earlier set and a pattern for consumer acceptance and
13
receptiveness to menu-based advisories emerged.
14
It became apparent that there is a general appreciation for “disclosure” of what
15
consumers view as “hidden ingredients,” for example, whether a particular
16
menu item contains raw egg. In addition to disclosure being viewed as helpful,
17
consumers are accepting, if not appreciative, of a “reminder” that consuming
18
raw or undercooked animal-derived foods carries an increased risk of
19
foodborne illness. In the food establishment venue, consumers are less willing
20
to accept a message that extends beyond a reminder and becomes a lesson
21
or an educational message.
22
Satisfactory Compliance:
Guam Food Code Annex 1 – Public Health Reasons
183
1
FDA submitted to the 1998 CFP meeting an Issue that asked the Conference
2
to discuss an approach that incorporated the knowledge obtained from the
3
consumer testing.
4
compliance with the Code’s consumer advisory provision is fulfilled when
5
both a disclosure and reminder are provided, as described in § 3-603.11 of the
6
Code. Disclosure is achieved when there is clear identification of animal-
7
derived foods that are sold or served raw or undercooked, and of items that either
8
contain or may contain (to allow for ingredient substitution) such raw or
9
undercooked ingredients. A third option for the consumer “reminder” was
10
added later. The reminder is a notice about the relationship between thorough
11
cooking and food safety.
12
Two options were endorsed for disclosure and two for the reminder. One of
13
the reminder options is a menu statement that advises consumers that food
14
safety information about the disclosed items is available upon request. Essential
15
criteria for such written information are available, with a downloadable model
16
brochure, on the CFSAN website at http://www.cfsan.fda.gov/~fc99guid.html. All
17
brochures must meet these essential criteria. The other option is a short notice
18
alerting consumers to the increased risk of consuming the disclosed menu items.
It was the consensus of the CFP that satisfactory
19
20
In response to concerns raised by the Interstate Shellfish Sanitation Conference
21
(ISSC) in an October 8, 1998 letter to FDA, a third option has been added to
22
allow for a statement that links an increased risk of illness to consumption of raw
23
or undercooked animal foods by persons with certain medical conditions.
Guam Food Code Annex 1 – Public Health Reasons
184
1
The information contained in both the disclosure and reminder should be
2
publicly available and readable so that consumers have benefit of the total message
3
(disclosure and reminder) before making their order selections.
4
It is not possible to anticipate all conceivable situations. Therefore, there will
5
always be need for discussion between the food establishment and the Regulatory
6
Authority as to the most effective way to meet the objectives of satisfactory
7
compliance.
8
The Implementation Guidance for the Consumer Advisory Provision of the FDA
9
Food Code (section 3-603.11 in the FDA Model Food Code), is a resource
10
intended to assist regulators and industry in the implementation of the Consumer
11
Advisory provision. It is recommended that it be used in conjunction with the
12
FDA
13
http://www.cfsan.fda.gov/~dms/fc99guid.html.
14
Locating the Advisory:
15
Disclosure of raw or undercooked animal-derived foods or ingredients and
16
reminders about the risk of consuming such foods belong at the point where
17
the food is selected by the consumer. Both the disclosure and the reminder
18
need to accompany the information from which the consumer makes a selection.
19
That information could appear in many forms such as a menu, a placarded listing
20
of available choices, or a table tent.
21
Educational Messages:
22
Educational messages are usually longer, more didactic in nature, and
23
targeted to consumers who have been alerted to the food safety concern and
Food Code.
It
is
available
on
the
FDA/CFSAN
Guam Food Code Annex 1 – Public Health Reasons
185
website at
1
take the initiative to obtain more detailed information. It is expected that, in
2
most cases, educational messages that are provided pursuant to § 3-603.11
3
(i.e., in situations where the option for referring the consumer to additional
4
information is chosen), will be embodied in brochures that will not be read at
5
the site where the immediate food choice is being made. Nonetheless, such
6
messages are viewed as an important facet of arming consumers with the
7
information needed to make informed decisions and, because the information is
8
being requested by the consumer, it
9
subsequent choices.
would
be expected to play a role in
10
Applicability:
11
Food Establishments:
12
The consumer advisory is intended to apply to all food establishments where
13
raw or undercooked animal foods or ingredients are sold or served for human
14
consumption in a raw or undercooked form.
15
establishments whenever there is a reasonable likelihood that the food will be
16
consumed without subsequent, thorough cooking - such as restaurants, raw bars,
17
quick-service operations, carry-outs, and sites where groceries are obtained
18
that have operations such as delicatessens or seafood departments.
19
This includes all types of food
“...Otherwise Processed to Eliminate Pathogens...”:
20
This phrase is included in § 3-603.11 to encompass new technologies and pathogen
21
control/reduction regimens as they are developed and validated as fulfilling a
22
specific performance standard for pathogens of concern. Pasteurization of milk is
23
an example of a long-standing validated process. For purposes of the Food Code,
Guam Food Code Annex 1 – Public Health Reasons
186
1
the level of pathogen reduction that is required before a raw or undercooked animal
2
food is allowed to be offered without a consumer advisory must be equivalent to
3
the levels provided by § 3-401.11 for the type of food being prepared.
4
The absorbed dose levels of radiation approved by FDA on December 3, 1997
5
for red meat are insufficient to reduce the level of most vegetative pathogens
6
to a point that is equivalent to the reductions achieved in ¶¶ 3-401.11(A) and
7
(B). Irradiated poultry provides a 3D kill which does not provide the level of
8
protection of the 7D kill that results from the cooking regimen in the Food Code.
9
Therefore, irradiated meat and poultry are not allowed to be offered in a ready-to-
10
eat form without a consumer advisory. It is intended that future Food Code revisions
11
will address time/temperature requirements that take into consideration the
12
pathogen reduction that occurs with irradiated foods.
13
Recognition of Other Processes:
14
Animal-derived foods may undergo validated processes that target a specific
15
pathogen. In such instances, along with the required consumer advisory may appear
16
additional language that accurately describes the process and what it achieves. For
17
example,
18
nondetectable levels has been validated. FDA concurs that shellfish subjected
19
to that process can be labeled with a truthful claim that appropriately describes
20
the product. That is, a statement could be made such as, “pasteurized to
21
reduce Vibrio vulnificus” or “temperature treated to reduce Vibrio vulnificus.”
22
Such a claim must be in accordance with labeling laws and regulations, accurate,
23
and not misleading.
a
technology
for reducing
Vibrio vulnificus
in oysters to
The claim would not, however, negate the need for a
Guam Food Code Annex 1 – Public Health Reasons
187
1
consumer advisory because the treatment only reduces the level of one
2
pathogenic organism.
3
Product-specific Advisories:
4
Consumer advisories may be tailored to be product-specific if a food establishment
5
either has a limited menu or offers only certain animal-derived foods in a raw or
6
undercooked
7
shellfish on the half shell, but no other raw or undercooked animal food, could
8
elect to confine its consumer advisory to shellfish. The raw bar could also
9
choose reminder, option #3, which would highlight the increased risk incurred
10
when persons with certain medical conditions ingest shellfish that has not
11
been adequately heat treated.
12
Terminology:
13
It should be noted that the actual on-site (e.g., on-the-menu) advisory
14
language differs from the language in the codified provision, § 3-603.11. In the
15
insert page for § 3-603.11, the Reminder options 2 and 3 use terms for foods
16
that are less specific than the terms used in the actual code section. That
17
is, the words “meat” rather than “beef, lamb, and pork” and “seafood” rather
18
than “fish” are used. Categorical terms like “meat” are simpler and may be
19
more likely used in conversation, making them suitable for purposes of a
20
menu notice.
ready-to-eat form.
For example, a raw bar serving molluscan
Guam Food Code Annex 1 – Public Health Reasons
188
1
Milk:
2
In addition, “milk” is not mentioned in the actual on-site advisory language.
3
The sale or transportation of final packaged form of unpasteurized milk into
4
interstate commerce is specifically prohibited by 21 CFR 1240.61.
5
consumption of raw milk is not recommended by FDA (this statement is in
6
the
7
http://www.cfsan.fda.gov/~ear/mi-03-4.html. Nonetheless, approximately 27 states
8
allow unpasteurized milk in intrastate commerce which usually involves direct
9
dairy farm-to-consumer procurement.
form
of
an
official
FDA
position
statement
Also the
found
at
10
In the event that a food establishment governed by § 3-603.11 of this Code operates
11
in conjunction with a dairy farm in a State that allows the in-State sale or service
12
of unpasteurized milk, or in the case where a State allows unpasteurized milk to
13
be marketed via retail-level food establishments, consumers need to be advised
14
of the risk associated with drinking unpasteurized milk. In these situations, the
15
actual
16
Consumer Advisory Reminder, paragraph 3-603.11(C), options 2 or 3).
17
Molluscan Shellstock:
18
In addition to areas of retail food stores such as delis in supermarkets, the
19
consumer advisory is to be provided when a seafood department or seafood market
20
offers raw molluscan shellstock for sale or service. There is a risk of
21
Vibrio infections from consuming raw molluscan shellstock for persons who have
22
certain medical conditions.
advisory language needs to be amended to
Guam Food Code Annex 1 – Public Health Reasons
189
include milk (refer to
death from
1
Disposition
3-701.11
2
Discarding or Reconditioning Unsafe,
Adulterated, or Contaminated Food.*
3
Pathogens may be transmitted from person to person through contaminated
4
food. The potential l spread of illness is limited when food is discarded if it
5
may have been contaminated by employees who are infected, or are
6
suspected of being infected, or by any person who otherwise contaminates it.
7
Additional
8
Safeguards
9
Refer to the public health reason for § 3-201.11.
3-801.11
Pasteurized Foods, Prohibited Re-Service,
and Prohibited Food.*
10
The Code provisions that relate to highly susceptible populations are combined
11
in this section for ease of reference and to add emphasis to special food
12
safety precautions
13
vulnerable to foodborne illness and for whom the implications of such illness
14
can be dire.
15
As a safeguard for highly susceptible populations from the risk of contracting
16
foodborne illness from juice, prepackaged juice is required to be obtained
17
pasteurized or in a commercially sterile, shelf-stable form in a hermetically sealed
18
container. It is important to note that the definition of a “juice” means it is
19
served as such or used as an ingredient in beverages.
20
vegetables, which are commonly prepared as food for service to highly susceptible
21
populations, are not juices and do not require HACCP plans or compliance with 21
22
CFR Part 120. There are documented cases of foodborne illness throughout
23
the United States that were associated with the consumption of various juice
that
are necessary to protect those who are particularly
Guam Food Code Annex 1 – Public Health Reasons
190
Puréed fruits and
1
products contaminated with microorganisms such as Cryptosporidium, Shiga
2
toxin-producing Escherichia coli, Salmonella spp., and Vibrio cholera. As
3
new information becomes available, the Food Code will be modified or interim
4
interpretive guidance will be issued regarding foodborne illness interventions for
5
on-site juicing and puréeing.
6
The 21 CFR 120 regulation applies to products sold as juice or used as an
7
ingredient in beverages. This includes fruit and vegetable purées that are
8
used in juices and beverages, but is not intended to include freshly prepared fruit
9
or vegetable purées that are prepared on-site in a facility for service to a
10
highly susceptible population.
11
In lieu of meeting the requirements of 21 CFR 120, juices that are produced
12
as commercially sterile products (canned juices) are acceptable for service to a
13
highly susceptible population.
14
susceptible populations may also wish to use fruit and vegetables that are produced
15
as commercially sterile products (canned fruit or vegetables) as a means of
16
enhancing food safety.
17
Salmonella often survives traditional preparation techniques. It survives in a lightly
18
cooked omelet, French toast, stuffed pasta, and meringue pies. In 1986 there was
19
a large multistate outbreak of Salmonella Enteritidis traced to stuffed pasta
20
made with raw eggs and labeled “fully cooked.” Eggs remain a major source of
21
these infections, causing
22
undercooked as was the case in the 1986 outbreak linked to stuffed pasta.
Persons providing puréed
meals to highly
large outbreaks when they are combined
Guam Food Code Annex 1 – Public Health Reasons
191
and
1
Therefore,
special
2
susceptible to foodborne illness.
3
Operators of food establishments serving highly susceptible populations may wish
4
to discuss buyer specifications with their suppliers. Such specifications could
5
stipulate eggs that are produced only by flocks managed under a Salmonella
6
Enteritidis control program that is recognized by a regulatory agency that has
7
animal health jurisdiction. Such programs are designed to reduce the presence
8
of
9
establishment operator must use adequate time and temperature controls within
10
the establishment to minimize the risk of a foodborne illness outbreak relating to
11
Salmonella Enteritidis.
12
Since
13
foodborne illness in the United States. The FDA and CDC have issued health
14
advisories that persons who are at a greater risk for foodborne disease should
15
avoid eating raw alfalfa sprouts until such time as intervention methods are in place
16
to improve the safety of these products. Further information is available at the
17
FDA website, http://www.fda.gov, by entering “sprouts” in the search window.
18
Although the Code’s allowance for the Regulatory Authority to grant a variance (refer
19
to §§ 8-103.10 - .12, 8-201.14, and 8-304.11) is applicable to all Code provisions,
20
variance requests related to the preparation of food for highly susceptible
21
populations must be considered with particular caution and scrutiny. With all
22
variances, the hazard(s) must be clearly identified and controlled by a HACCP
23
plan that is instituted in conjunction with a standard operating plan that implements
Salmonella
1995, raw
added precautions need to be in place with those most
Enteritidis in raw shell eggs.
seed sprouts have
In any case, the food
emerged as a recognized source of
Guam Food Code Annex 1 – Public Health Reasons
192
1
good retail practices. Variances that will impact a highly susceptible population
2
must be considered in light of the fact that such a population is at a
3
significantly higher risk of contracting foodborne illnesses and suffering serious
4
consequences
5
population.
6
Subparagraph 3-801.11(F)(3) requires a HACCP plan for the use of raw shell
7
eggs
8
susceptible populations. A variance is not required since the HACCP plan criteria
9
are specific, prescriptive, and conservative and require a cooking temperature and
10
when
including
eggs
are
death from those illnesses, than is
combined
in
food
the
general
establishments serving highly
time to ensure destruction of Salmonella Enteritidis.
11
3-801.11(G) and (H) Re-service of food
12
The Food Code addresses two issues concerning persons in isolation:
13
1.
14
The re-service of any food including unopened, original, intact packages in
15
sound condition, of non-potentially hazardous food (temperature controlled for
16
safety) from a person in isolation or quarantine for use by anyone else (other
17
patients, clients, or consumers) is not permitted. The “isolation or quarantine”
18
terminology in the Code text refers to a patient-care setting that isolates the
19
patient, thereby preventing spread of key pathogens to other patients and
20
healthcare workers. Once food packages come to a contact isolation room, they
21
stay there until the patient uses or discards them. If packages of food are still
22
in the room when the patient is discharged or moved from isolation, they
23
must be discarded.
Contamination from an isolated patient to others outside.
Guam Food Code Annex 1 – Public Health Reasons
193
1
2.
2
environment” isolation setting which protects the patient from contacting
3
pathogens from other patients, healthcare workers, or other persons.
4
Packages of food from any patients, clients or other consumers should not be
5
re-served to persons in protective environment isolation. Precautions similar to
6
the
7
intact package of condiment is delivered to this patient, the package stays there
8
until used or discarded. New (not re-served)
9
delivered to this patient each time.
10
11
Contamination from the outside into a room with a patient in a “protective
isolation setting apply to this setting, i.e., once an unopened, original,
packages of food should
be
To summarize the key difference between the two scenarios:

Food packages served to patients in contact isolation may not be re-
12
served to other patients because of the potential for disease
13
transmission to other patients.
14

Patients in protective environments should not be re-served with
15
food packages from other patients because of the potential for
16
disease transmission to the protective environment patient.
17
Chapter 4 Equipment, Utensils, and Linens
18
Multiuse
19
Multiuse equipment is subject to deterioration because of its nature, i.e., intended
20
use over an
21
chemicals to be transferred to the food being prepared which could lead to
22
foodborne illness. In addition, some materials can affect the taste of the food being
23
prepared. Surfaces that are unable to be routinely cleaned and sanitized because
4-101.11
Characteristics.*
extended period of time. Certain materials allow harmful
Guam Food Code Annex 1 – Public Health Reasons
194
1
of the materials used could harbor foodborne pathogens.
2
surfaces of equipment such as pitting may inhibit adequate cleaning of the
3
surfaces of equipment, so that food prepared on or in the equipment becomes
4
contaminated.
5
Inability to effectively wash, rinse
6
equipment may lead to the buildup of pathogenic organisms transmissible through
7
food. Studies regarding the rigor required to remove biofilms from smooth
8
surfaces highlight the need for materials of optimal quality in multiuse equipment.
9
4-101.12
Deterioration of the
and sanitize the surfaces of food
Cast Iron, Use Limitation.
10
Equipment and utensils constructed of cast iron meet the requirement of durability
11
as intended in section 4-101.11. However, the surface characteristics of cast
12
iron tend to be somewhat porous which renders the material difficult to clean. On
13
the other hand, when cast iron use is limited to cooking surfaces the residues
14
in the porous surface are not of significant concern as heat destroys potential
15
pathogens that may be present.
16
4-101.13
Lead, Use Limitation.
17
Historically, lead has been used in the formulation or decoration of these types
18
of utensils. Specifically, lead-based paints that were used to decorate the
19
utensils such as color glazes have caused high concentrations of lead to
20
leach into the food they contain.
21
Lead poisoning continues to be an important public health concern due to the
22
seriousness of associated medical problems.
23
harmful to the young and has caused learning disabilities and medical
Lead poisoning is particularly
Guam Food Code Annex 1 – Public Health Reasons
195
1
problems among individuals who have consumed high levels. The allowable
2
levels of lead are specific to the type of utensil, based on the average contact
3
time and properties of the foods routinely stored in each item listed.
4
FDA has established maximum levels (see FDA Compliance Policy Guide
5
Section 545.450 Pottery (Ceramics); Imported and Domestic – Lead Contamination
6
(CPG 7117.07) for leachable lead in ceramicware, and pieces that exceed these
7
levels are subject to recall or other agency enforcement action. The levels are
8
based on how frequently a piece of ceramicware is used, the type and
9
temperature of the food it holds, and how long the food stays in contact with the
10
piece. For example, cups, mugs, and pitchers have the most stringent action level,
11
0.5 parts per million, because they can be expected to hold food longer, allowing
12
more time for lead to leach. Also, a pitcher may be used to hold fruit juice. And a
13
coffee mug is generally used every day to hold a hot acidic beverage, often
14
several times a day.
15
The FDA allows use of lead glazes because they’re the most durable, but regulates
16
them tightly to ensure their safety. Commercial manufacturers employ extremely
17
strict and effective manufacturing controls that keep the lead from leaching during
18
use. Small potters often can’t control the firing of lead glazes as well so their
19
ceramics are more likely to leach illegal lead levels, although many do use
20
lead-free glazes.
21
In 21 CFR 109.16, FDA requires high-lead-leaching decorative ceramicware
22
to be permanently labeled that it’s not for food use and may poison food. Such
Guam Food Code Annex 1 – Public Health Reasons
196
1
items bought outside the United States may not be so labeled, potentially
2
posing serious risk if used for food.
3
Pewter refers to a number of silver-gray alloys of tin containing various
4
amounts of antimony, copper, and lead.
5
leaching of heavy metals and lead that apply to brass, galvanized metals, copper,
6
cast iron, ceramics, and crystal also apply to pewter. As previously stated,
7
the storage of acidic moist foods in pewter containers could result in food
8
poisoning (heavy metal poisoning).
9
Solder is a material that is used to join metallic parts and is applied in the
10
melted state to solid metals. Solder may be composed of tin and lead alloys.
11
4-101.14
The same concerns about the
Copper, Use Limitation.*
12
High concentrations of copper are poisonous and have caused foodborne
13
When copper and copper alloy surfaces contact acidic foods, copper may be
14
leached into the food. Carbon dioxide may be released into a water supply
15
because of an ineffective or nonexistent backflow prevention device between a
16
carbonator and copper plumbing components. The acid that results from mixing
17
water and carbon dioxide leaches copper from the plumbing components and
18
the leachate is then transferred to
19
Backflow prevention devices constructed of copper and copper alloys can cause,
20
and have resulted in, the leaching of both copper and lead into carbonated
21
beverages.
22
Brass is an alloy of copper and zinc and contains lead which is used to
23
combine the two elements. Historically, brass has been used for items such as
beverages,
causing copper poisoning.
Guam Food Code Annex 1 – Public Health Reasons
197
illness.
1
pumps, pipe fitting, and goblets. All 3 constituents are subject to leaching when
2
they contact acidic foods, and food poisoning has resulted from such contact.
3
The steps in beer brewing include malting, mashing, fermentation, separation of
4
the alcoholic beverage from the mash, and rectification. During mashing, it is
5
essential to lower the pH from its normal 5.8 in order to optimize enzymatic
6
activity. The pH is commonly lowered to 5.1-5.2, but may be adjusted to as low
7
as 3.2. The soluble extract of the mash (wort) is boiled with hops for 1 to 22
8
hours or more. After boiling, the wort is cooled, inoculated with brewers yeast, and
9
fermented.
The use of copper equipment during the prefermentation and
10
fermentation steps typically result in some leaching of copper.
11
Because copper is an essential nutrient for yeast growth, low levels of copper are
12
metabolized by the yeast during fermentation. However, studies have shown that
13
copper levels above 0.2 mg/L are toxic or lethal to the yeast. In addition, copper
14
levels as low as 3.5 mg/L have been reported to cause symptoms of copper
15
poisoning in humans. Therefore, the levels of copper necessary for successful beer
16
fermentation (i.e., below 0.2 mg/L) do not reach a level that would be toxic to
17
humans.
18
Today, domestic beer brewers typically endeavor to use only stainless steel or
19
stainless steel-lined copper equipment (piping, fermenters, filters, holding tanks,
20
bottling machines, keys, etc.) in contact with beer following the hot brewing steps in
21
the beer making process. Some also use pitch-coated oak vats or glass-lined
22
steel vats following the hot brewing steps. Where copper equipment is not used
Guam Food Code Annex 1 – Public Health Reasons
198
1
in beer brewing, it is common practice to add copper (along with zinc) to provide
2
the nutrients essential to the yeast for successful fermentation.
3
4-101.15
Galvanized Metal, Use Limitation.*
4
Galvanized means iron or steel coated with zinc, a heavy metal that may be
5
leached from galvanized containers into foods that are high in water content.
6
The risk of leaching increases with increased acidity of foods contacting the
7
galvanized container.
8
4-101.16
Sponges, Use Limitation.
9
Sponges are difficult, if not impossible, to clean once they have been in contact
10
with food particles and contaminants that are found in the environment. Because of
11
their construction, sponges provide harborage for any number and variety of
12
microbiological organisms, many
13
sponges are to be used only where they will not contaminate cleaned and
14
sanitized or in-use, food-contact surfaces such as for cleaning equipment and
15
utensils before rinsing and sanitizing.
16
4-101.17
of
which may be pathogenic.
Therefore,
Wood, Use Limitation.
17
The limited acceptance of the use of wood as a food-contact surface is determined
18
by the nature of the food and the type of wood used. Moist foods may cause the
19
wood surface to deteriorate and the surface may become difficult to clean. In
20
addition, wood that is treated with preservatives may result in illness due to the
21
migration of the preservative chemicals to the food; therefore, only specific
22
preservatives are allowed.
23
4-101.18
Nonstick Coatings, Use Limitation.
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199
1
Perfluorocarbon resin is a tough, nonporous and stable plastic material that
2
gives cookware and bakeware a surface to which foods will not stick and that
3
cleans easily and quickly. FDA has approved the use of this material as safe for
4
food-contact surfaces. The Agency has determined that neither the particles that
5
may chip off nor the fumes given off at high temperatures pose a health hazard.
6
However, because this nonstick finish may be scratched by sharp or rough-
7
edged kitchen tools, the manufacturer's recommendations should be consulted and
8
the use of utensils that may scratch, abrasive scouring pads, or cleaners avoided.
9
4-101.19
Nonfood-Contact Surfaces.
10
Nonfood-contact surfaces of equipment routinely exposed to splash or food
11
are required to be constructed of nonabsorbent materials to facilitate cleaning.
12
Equipment
13
organisms, moisture, and debris and deters the attraction of rodents and insects.
14
Single-Service
15
and Single-Use
16
The safety and quality of food can be adversely affected through single service and
17
single use articles that are not constructed of acceptable materials. The migration of
18
components of those materials to food they contact could result in chemical
19
contamination and illness to the consumer. In addition, the use of unacceptable
20
materials could adversely affect the quality of the food because of odors, tastes,
21
and colors transferred to the food.
22
Durability and
23
Strength
that
is easily cleaned
4-102.11
4-201.11
minimizes
the presence of pathogenic
Characteristics.*
Equipment and Utensils.
Guam Food Code Annex 1 – Public Health Reasons
200
debris
1
Equipment and utensils must be designed and constructed to be durable and
2
capable of retaining their original characteristics so that such items can continue
3
to fulfill their intended purpose for the duration of their life expectancy and to
4
maintain their easy cleanability. If they can not maintain their original characteristics,
5
they may become difficult to clean, allowing for the harborage of pathogenic
6
microorganisms, insects, and rodents.
7
designed and constructed so that parts do not break and end up in food as
8
foreign objects or present injury hazards to consumers. A common example of
9
presenting an injury hazard is the tendency for tines of poorly designed single
10
11
Equipment and utensils must
be
service forks to break during use.
4-201.12
Food Temperature Measuring Devices.*
12
Food temperature measuring devices that have glass sensors or stems present
13
a likelihood that glass will end up in food as a foreign object and create an injury
14
hazard to the consumer. In addition, the contents of the temperature measuring
15
device, e.g., mercury, may contaminate food or utensils.
16
Cleanability 4-202.11
17
The purpose of the requirements for multiuse food-contact surfaces is to
18
ensure that such surfaces are capable of being easily cleaned and accessible for
19
cleaning. Food-contact surfaces that do not meet these requirements provide a
20
potential harbor for foodborne pathogenic organisms.
21
imperfections such as cracks, chips, or pits allow microorganisms to attach and
22
form biofilms. Once established, these biofilms can release pathogens to food.
23
Biofilms are highly resistant to cleaning and sanitizing efforts. The requirement for
Food-Contact Surfaces.*
Guam Food Code Annex 1 – Public Health Reasons
201
Surfaces which have
1
easy disassembly recognizes the reluctance of food employees to disassemble
2
and clean equipment if the task is difficult or requires the use of special,
3
complicated tools.
4
4-202.12
CIP Equipment.
5
Certain types of equipment are designed to be cleaned in place (CIP) where it is
6
difficult or impractical to disassemble the equipment for cleaning. Because of
7
the closed nature of the system, CIP cleaning must be monitored via access points
8
to ensure that cleaning has been effective throughout the system.
9
The CIP design must ensure that all food-contact surfaces of the equipment are
10
contacted by the circulating cleaning and sanitizing solutions. Dead spots in
11
the system, i.e., areas which are not contacted by the cleaning and sanitizing
12
solutions, could result in the buildup of food debris and growth of pathogenic
13
microorganisms. There is equal concern that cleaning and sanitizing solutions might
14
be retained in the system, which may result in the inadvertent adulteration of
15
food. Therefore, the CIP system must be self-draining.
16
4-202.13
“V” Threads, Use Limitation.
17
V-type threads present a surface which is difficult to clean routinely; therefore, they
18
are not allowed on food-contact surfaces. The exception provided for hot oil
19
cooking fryers and filtering systems is based on the high temperatures that are
20
used in this equipment. The high temperature in effect sterilizes the equipment,
21
including debris in the “V” threads.
22
4-202.14
Hot Oil Filtering Equipment.
Guam Food Code Annex 1 – Public Health Reasons
202
1
To
2
requirements, §§ 4-202.11 and 4-202.12 must be followed. The filter is designed
3
to keep the oil free of undesired materials and therefore must be readily
4
accessible for replacement. Filtering the oil reduces the likelihood that off-odors,
5
tastes, and possibly toxic compounds may be imparted to food as a result of
6
debris buildup. To ensure that filtering occurs, it is necessary for the filter to
7
be accessible for replacement.
8
facilitate
and
ensure
effective
4-202.15
cleaning
of
this equipment, Code
Can Openers.
9
Once can openers become pitted or the surface in any way becomes uncleanable,
10
they must be replaced because they can no longer be adequately cleaned and
11
sanitized. Can openers must be designed to facilitate replacement.
12
4-202.16
Nonfood-Contact Surfaces.
13
Hard-to-clean areas could result in the attraction and harborage of insects and
14
rodents and allow the growth of foodborne pathogenic microorganisms. Well-
15
designed equipment enhances the ability to keep nonfood-contact surfaces clean.
16
4-202.17
Kick Plates, Removable.
17
The use of kick plates is required to allow access for proper cleaning. If kick
18
plate design and installation does not meet Code requirements, debris could
19
accumulate and create a situation that may attract insects and rodents.
Guam Food Code Annex 1 – Public Health Reasons
203
1
Accuracy
2
The Metric Conversion Act of 1975 (amended 1988, 1996, and 2004,
3
205a et seq) requires that all Federal government regulations use the Celsius
4
Scale for temperature measurement. The Fahrenheit scale is included in the
5
Code for those jurisdictions using the Fahrenheit scale for temperature
6
measurement.
7
The small margin of error specified for thermometer accuracy is due to the lack
8
of a large safety margin in the temperature requirements themselves. The accuracy
9
specified for a particular food temperature measuring device is applicable to its
10
entire range of use, that is, from refrigeration through cooking temperatures if the
11
device is intended for such use.
12
4-203.12
4-203.11
Temperature Measuring Devices, Food.
15 USC
Temperature Measuring Devices, Ambient Air and Water.
13
A temperature measuring device used to measure the air temperature in a
14
refrigeration unit is not required to be as accurate as a food thermometer because
15
the unit's temperature fluctuates with repeated opening and closing of the door
16
and because accuracy in measuring
17
significance.
18
The Celsius scale is the federally recognized scale based on The Metric Conversion
19
Act of 1975 (amended 1988, 1996, and 2004, 15 USC 205a et seq) which requires
20
the use of metric values. The ±1.5oC requirement is more stringent than the 3oF
21
previously required since ±1.5oC is equivalent to ±2.7oF. The more rigid
22
accuracy results from the practical application of metric equivalents to the
23
temperature gradations of Celsius thermometers.
internal
food temperatures is of more
Guam Food Code Annex 1 – Public Health Reasons
204
1
If Fahrenheit thermometers are used, the 3oF requirement applies because of the
2
calibrated intervals of Fahrenheit thermometers.
3
The accuracy specified for a particular air or water temperature measuring device
4
is applicable to its intended range of use. For example, a cold holding unit may
5
have a temperature measuring device that measures from a specified frozen
6
temperature to 20oC (68oF). The device must be accurate to specifications within
7
that use range.
8
4-203.13
9
Pressure Measuring Devices, Mechanical
Warewashing Equipment.
10
Flow pressure is a very important factor with respect to the efficacy of sanitization.
11
A pressure below the design pressure results in inadequate spray patterns and
12
incomplete coverage of the utensil surfaces to be sanitized. Excessive flow
13
pressure will tend to atomize the water droplets needed to convey heat into a
14
vapor mist that cools before reaching the surfaces to be sanitized.
15
Functionality
16
The dripping of grease or condensation onto food constitutes adulteration and
17
may involve contamination of the food with pathogenic organisms. Equipment,
18
utensils, linens, and single service and single use articles that are subjected to such
19
drippage are no longer clean.
20
4-204.11
4-204.12
Ventilation Hood Systems, Drip Prevention.
Equipment Openings, Closures and Deflectors.
21
Equipment openings and covers must be designed to protect stored or prepared
22
food from contaminants and foreign matter that may fall into the food. The
23
requirement for an opening to be flanged upward and for the cover to overlap the
Guam Food Code Annex 1 – Public Health Reasons
205
1
opening and be sloped to drain prevents contaminants, especially liquids, from
2
entering the food-contact area.
3
Some equipment may have parts that extend into the food-contact areas. If these
4
parts are not provided with a watertight joint at the point of entry into the food-
5
contact area, liquids may contaminate the food by adhering to shafts or other
6
parts and running or dripping into the food.
7
An apron on parts extending into the food-contact area is an acceptable alternative
8
to the watertight seal.
9
condensation, drips, and dust may gain access to the food.
If
the apron is not properly designed and installed,
10
4-204.13
11
This requirement is intended to protect both the machine-dispensed, unpackaged,
12
liquid foods and the machine components from contamination. Barriers need to be
13
provided so that the only liquid entering the food container is the liquid intended to
14
be dispensed when the machine's mechanism is activated. Recessing of the
15
machine's components and self-closing doors prevent contamination of machine
16
ports by people, dust, insects, or rodents. If the equipment components become
17
contaminated, the product itself will be exposed to possible contamination.
18
A direct opening into the food being dispensed allows dust, vermin, and other
19
contaminants access to the food.
20
Dispensing Equipment, Protection of Equipment and Food.
4-204.14
Vending Machine, Vending Stage Closure.
21
Since packaged foods dispensed from vending machines could attract insects
22
and rodents, a self-closing door is required as a barrier to their entrance.
23
4-204.15
Bearings and Gear Boxes, Leakproof.
Guam Food Code Annex 1 – Public Health Reasons
206
1
It is not unusual for food equipment to contain bearings and gears. Lubricants
2
necessary for the operation of these types of equipment could contaminate food
3
or food-contact surfaces if the equipment is not properly designed and constructed.
4
4-204.16
Beverage Tubing, Separation.
5
Beverage tubing and coldplate cooling devices may result in contamination if they
6
are installed in direct contact with stored ice. Beverage tubing installed in contact
7
with ice may result in condensate and drippage contaminating the ice as the
8
condensate moves down the beverage tubing and ends up in the ice.
9
The presence of beverage tubing and/or coldplate cooling devices also presents
10
cleaning problems. It may be difficult to adequately clean the ice bin if they are
11
present. Because of the high moisture environment, mold and algae may form
12
on the surface of the ice bins and any tubing or equipment stored in the bins.
13
14
4-204.17
Ice Units, Separation of Drains.
15
Liquid waste drain lines passing through ice machines and storage bins present
16
a risk of contamination due to potential leakage of the waste lines and the
17
possibility that contaminants will gain access to the ice through condensate
18
migrating along the exterior of the lines.
19
Liquid drain lines passing through the ice bin are, themselves, difficult to clean and
20
create other areas that are difficult to clean where they enter the unit as well as
21
where they abut other surfaces. The potential for mold and algal growth in this
22
area is very likely due to the high moisture environment. Molds and algae that
Guam Food Code Annex 1 – Public Health Reasons
207
1
form on the drain lines are difficult to remove and present a risk of contamination to
2
the ice stored in the bin.
3
4-204.18
Condenser Unit, Separation.
4
A dust-proof barrier between a condenser and food storage areas of equipment
5
protects food and food-contact areas from contamination by dust that is
6
accumulated and blown about as a result of the condenser's operation.
7
4-204.19
Can Openers on Vending Machines.
8
Since the cutting or piercing surfaces of a can opener directly contact food in
9
The container being opened, these surfaces must be protected from
10
contamination.
11
4-204.110
Molluscan Shellfish Tanks.
12
Shellfish are filter feeders allowing concentration of pathogenic microorganisms that
13
may be present in the water. Due to the number of shellfish and the limited
14
volume of water used, display tanks may allow concentration of
15
viruses and bacteria.
16
Since many people eat shellfish either raw or lightly cooked, the potential for
17
increased levels of pathogenic microorganisms in shellfish held in display tanks
18
of concern.
19
consumption, certain safeguards must be in place as specified in a detailed HACCP
20
plan that is approved by the regulatory authority. Opportunities for contamination
21
must be controlled or eliminated. Procedures must emphasize strict monitoring of
22
the water quality of the tank including the filtering and disinfection system.
pathogenic
is
If shellfish stored in molluscan shellfish tanks are offered for
Guam Food Code Annex 1 – Public Health Reasons
208
1
4-204.111
Vending Machines, Automatic Shutoff.*
2
Failure to store potentially hazardous (time/temperature control for safety) food at
3
safe temperatures in a vending machine could result in the growth of pathogenic
4
microorganisms that may result in foodborne illness. The presence of an automatic
5
control that prevents the vending of food if the temperature of the unit exceeds Code
6
requirements precludes the vending of foods that may not be safe.
7
It is possible and indeed very likely that the temperature of the storage area of
8
a vending machine may exceed Code requirements during the stocking and
9
servicing of the machine. The automatic shut off, commonly referred to as the
10
“public health control,” provides a limited amount of time that the ambient
11
temperature of a machine may exceed Code requirements. Strict adherence to
12
the time requirements can limit the growth of pathogenic microorganisms.
13
4-204.112
Temperature Measuring Devices.
14
The placement of the temperature measuring device is important. If the device
15
is placed in the coldest location in the storage unit, it may not be representative of
16
the temperature of the unit. Food could be stored in areas of the unit that exceed
17
Code requirements. Therefore, the temperature measuring device must be placed
18
in a location that is representative of the actual storage temperature of the
19
unit to ensure that all potentially hazardous (time/temperature control for safety)
20
foods are stored at least at the minimum temperature required in Chapter 3.
21
Installing an air thermometer in some open display refrigerators can be difficult
22
without physically impairing the usability of the case and interfering with cleaning
23
and sanitation. Use of a temperature monitoring system that uses probe-like
Guam Food Code Annex 1 – Public Health Reasons
209
1
sensors
that
are
placed in material resembling the density of food is an
2
acceptable alternative. Thus, the direct temperature of the substitute product is
3
measured by use of this product mimicking method.
4
A permanent temperature measuring
5
potentially hazardous (time/temperature control for safety) food because of the
6
potential growth of pathogenic microorganisms should the temperature of the unit
7
exceed Code requirements. In order to facilitate routine monitoring of the unit, the
8
device must be clearly visible.
9
The exception to requiring a temperature measuring device for the types of
10
equipment listed is primarily due to equipment design and function. It would be
11
difficult and impractical to permanently mount a temperature measuring device
12
on the equipment listed. The futility of attempting to measure the temperature of
13
unconfined air such as with heat lamps and, in some cases, the brief period of
14
time the equipment is used for a given food negate the usefulness of ambient
15
temperature monitoring at that point. In such cases, it would be more practical
16
and accurate to measure the internal temperature of the food.
17
The importance of maintaining potentially hazardous (time/temperature control
18
for safety) foods at the specified temperatures requires that temperature measuring
19
devices be easily readable. The inability to accurately read a thermometer could
20
result in food being held at unsafe temperatures.
21
Temperature measuring devices must be appropriately scaled per Code
22
requirements to ensure accurate readings.
23
The required incremental gradations are
device is required in any unit storing
more
precise for food measuring
Guam Food Code Annex 1 – Public Health Reasons
210
1
devices than for those used to measure ambient temperature because of the
2
significance at a given point in time, i.e., the potential for pathogenic growth, versus
3
the unit's temperature.
4
ambient temperature of the storage unit; it will depend on many variables including
5
the temperature of the food when it is placed in the unit, the temperature at which
6
the unit is maintained, and the length of time the food is stored in the unit.
7
4-204.113
8
9
The food temperature will not necessarily match the
Warewashing Machine, Data Plate Operating
Specifications.
The data plate provides the operator with the fundamental information needed
to
10
ensure that the machine is effectively washing, rinsing, and sanitizing equipment
11
and utensils. The warewashing machine has been tested, and the information on
12
the data plate represents the parameters that ensure effective operation and
13
sanitization and that need to be monitored.
14
4-204.114
Warewashing Machines, Internal Baffles.
15
The presence of baffles or curtains separating the various operational cycles of
16
a warewashing machine such as washing, rinsing, and sanitizing are designed
17
to reduce the possibility that solutions from one cycle may contaminate
18
solutions in another. The baffles or curtains also prevent food debris from
19
being splashed onto the surface of equipment that has moved to another
20
cycle in the procedure.
21
4-204.115
Warewashing Machines, Temperature Measuring Devices.
22
The requirement for the presence of a temperature measuring device in each tank
23
of the warewashing machine is based on the importance of temperature in
Guam Food Code Annex 1 – Public Health Reasons
211
1
the sanitization step. In hot water machines, it is critical that minimum temperatures
2
be met at the various cycles so that the cumulative effect of successively rising
3
temperatures causes the surface of the item being washed to reach the required
4
temperature for sanitization. When chemical sanitizers are used, specific minimum
5
temperatures must be met because the effectiveness of chemical sanitizers is
6
directly affected by the temperature of the solution.
7
4-204.116
Manual Warewashing Equipment, Heaters and Baskets.
8
Hot water sanitization is accomplished in water of not less than 77oC (170oF)
9
and an integral heating device is necessary to
ensure that the minimum
10
temperature is reached.
11
The rack or basket is required in order to safely handle the equipment and
12
utensils being washed and to ensure immersion. Water at this temperature could
13
result in severe burns to employees operating the equipment.
14
4-204.117
15
Warewashing Machines, Automatic Dispensing of
Detergents and Sanitizers.
16
The presence of adequate detergents and sanitizers is necessary to effect
17
and sanitized utensils and equipment. The automatic dispensing of these chemical
18
agents, plus a method such as a flow indicator, flashing light, buzzer, or visible
19
open air delivery system that alerts the operator that the chemicals are no longer
20
being dispensed, ensures that utensils are subjected to an efficacious cleaning and
21
sanitizing regimen.
22
23
4-204.118
clean
Warewashing Machines, Flow Pressure Device.
Flow pressure is a very important factor impacting the efficacy of sanitization in
Guam Food Code Annex 1 – Public Health Reasons
212
1
machines that use fresh hot water at line-pressure as a final sanitization rinse.
2
(See discussion in Public Health Reason for section 4-203.13.) It is important that
3
the operator be able to monitor, and the food inspector be able to check,
4
sanitization rinse pressure as well as machine water temperatures. ANSI/NSF
5
Standard #3, a national voluntary consensus standard for Commercial Spray-Type
6
Dishwashing Machines, specifies that a pressure gauge or
7
provided on this type machine and such devices are shipped with machines by the
8
manufacturer. Flow pressure devices installed on the upstream side of the control
9
(solenoid) valve are subject to damage and failure due to the water hammer effect
10
caused throughout the dishwashing period each time the control valve closes.
11
The IPS valve provides a ready means for checking line-pressure with an alternative
12
pressure measuring device. A flow pressure device is not required on machines
13
that use only a pumped or recirculated sanitizing rinse since an appropriate pressure
14
is ensured by a pump and is not dependent upon line-pressure.
15
4-204.121
final
similar device be
Vending Machines, Liquid Waste Products.
16
The presence of internal waste containers allows for the collection of liquids that
17
spill within the vending machine. Absence of a waste container or, where required,
18
a shutoff valve which controls the incoming liquids could result in wastes spilling
19
within the machine, causing a condition that attracts insects and rodents and
20
compounds cleaning and maintenance problems.
21
4-204.122
Case Lot Handling Equipment, Moveability.
22
Proper design of case lot handling equipment facilitates moving case lots for
23
cleaning and for surveillance of insect or rodent activity.
Guam Food Code Annex 1 – Public Health Reasons
213
1
4-204.123
Vending Machine Doors and Openings.
2
The objective of this requirement is to provide a barrier against the entrance into
3
vending machines of insects, rodents, and dust.
4
openings deters the entrance of common pests.
5
Acceptability
4-205.10
6
The maximum size of the
Food Equipment, Certification and
Classification.
7
Under ANSI document CA-1 ANSI Policy and Criteria for Accreditation of
8
Certification Programs, it has been stipulated that:
9
“For food equipment programs, standards that establish sanitation requirements
10
shall be specified government standards or standards that have been ratified by
11
a public health approval step. ANSI shall verify that this requirement has been
12
met by communicating with appropriate standards developing organizations and
13
governmental public health bodies.”
14
The term certified is used when an item of food equipment has been evaluated
15
against an organization's own standard. The term classified is used when one
16
organization evaluates an item of food equipment against a standard developed
17
by another organization.
18
Equipment 4-301.11
19
The ability of equipment to cool, heat, and maintain potentially hazardous
20
(time/temperature control for safety) foods at Code-required temperatures is
21
critical to food safety. Improper holding and cooking temperatures continue to be
22
major contributing factors to foodborne illness. Therefore, it is very important to
23
have adequate hot or cold holding equipment with enough capacity to meet the
Cooling, Heating, and Holding Capacities.
Guam Food Code Annex 1 – Public Health Reasons
214
1
2
heating and cooling demands of the operation.
4-301.12
Manual Warewashing, Sink Compartment Requirements.
3
The 3 compartment requirement allows for proper execution of the 3-step manual
4
warewashing procedure.
5
chance of contaminating the sanitizing water and therefore diluting the strength
6
and efficacy of the chemical sanitizer that may be used.
7
Alternative
8
circumstances and conditions, must provide for accomplishment of the same 3
9
steps:
manual
If properly used, the 3 compartments reduce the
warewashing
equipment,
allowed
under certain
10
1.
Application of cleaners and the removal of soil;
11
2.
Removal of any abrasive and removal or dilution of cleaning
12
13
14
15
chemicals; and
3.
Sanitization.
Refer also to the public health reason for § 4-603.16.
4-301.13
Drainboards.
16
Drainboards or equivalent equipment are necessary to separate soiled and cleaned
17
items from each other and from the food preparation area in order to preclude
18
contamination of cleaned items and of food.
19
Drainboards allow for the control of water running off equipment and utensils that
20
have been washed and also allow the operator to properly store washed equipment
21
and utensils while they air-dry.
Guam Food Code Annex 1 – Public Health Reasons
215
1
4-301.14
Ventilation Hood Systems, Adequacy.
2
If a ventilation system is inadequate, grease and condensate may build up on the
3
floors, walls and ceilings of the food establishment, causing an insanitary condition
4
and possible deterioration of the surfaces of walls and ceilings. The accumulation of
5
grease and condensate may contaminate food and food-contact surfaces as
6
well as present a possible fire hazard.
7
Refer also to the public health reason for § 4-204.11.
8
4-301.15
Clothes Washers and Dryers.
9
To protect food, soiled work clothes or linens must be efficiently laundered.
10
The only practical way of efficiently laundering work clothes on the premises is
11
with the use of a mechanical washer and dryer.
12
Refer also to the public health reason for § 4-401.11.
13
Utensils,
14
Temperature
15
Measuring Devices, and
16
Testing Devices
4-302.11
Utensils, Consumer Self-Service.
Guam Food Code Annex 1 – Public Health Reasons
216
1
Appropriate serving utensils provided at each container will, among other
2
reduce the likelihood of food tasting, use of fingers to serve food, use of fingers to
3
remove the remains of one food on the utensil so that it may be used for another,
4
use of soiled tableware to transfer food, and cross contamination between foods,
5
including a raw food to a cooked potentially hazardous (time/temperature control for
6
safety) food.
7
4-302.12
things,
Food Temperature Measuring Devices.
8
The presence and accessibility of food temperature measuring devices is critical
9
to the effective monitoring of food temperatures. Proper use of such devices
10
provides the operator or person in charge with important information with which
11
to determine if temperatures should be adjusted or if foods should be discarded.
12
When determining the temperature of thin foods, those having a thickness less than
13
13 mm (1/2 inch), it is particularly important to use a temperature sensing probe
14
designed for that purpose. Bimetal, bayonet style thermometers are not suitable for
15
accurately measuring the temperature of thin foods such as hamburger patties
16
because of the large diameter of the probe and the inability to accurately sense
17
the temperature at the tip of the probe. However, temperature measurements in
18
thin foods can be accurately determined using a small-diameter probe 1.5 mm
19
(0.059 inch), or less, connected to a device such as
thermocouple thermometer.
20
21
22
23
4-302.13
Temperature Measuring Devices, Manual
Warewashing.
Water temperature is critical to sanitization in warewashing operations. This is
Guam Food Code Annex 1 – Public Health Reasons
217
1
particularly true if the sanitizer being used is hot water. The effectiveness of
2
cleaners and chemical sanitizers is also determined by the temperature of the water
3
used. A temperature measuring device is essential to monitor manual warewashing
4
and ensure sanitization.
5
4-302.14
Sanitizing Solutions, Testing Devices.
6
Testing devices to measure the
7
required for 2 reasons:
8
1.
9
12
of sanitizing solutions are
The use of chemical sanitizers requires minimum concentrations
of the sanitizer during the final rinse step to ensure sanitization;
10
11
concentration
and
2.
Location
Too much sanitizer in the final rinse water could be toxic.
4-401.11
13
Equipment, Clothes Washers and Dryers, and
Storage Cabinets, Contamination Prevention.
14
Food equipment and the food that contacts the equipment must be protected from
15
sources of overhead contamination such as leaking or ruptured water or sewer
16
pipes, dripping condensate, and falling objects. When equipment is installed, it
17
must be situated with consideration of the potential for contamination from such
18
overhead sources.
19
If a clothes washer and dryer are installed adjacent to exposed food, clean
20
equipment, utensils,
21
articles, it could result in those items becoming contaminated from soiled laundry.
22
The reverse is also true, i.e., items being laundered could become contaminated
23
from the surrounding area if the washer and dryer are not properly located.
linens,
and
unwrapped
single-service and single-use
Guam Food Code Annex 1 – Public Health Reasons
218
1
Installation 4-402.11
2
This section is designed to ensure that fixed equipment is installed in a way
3
that:
4
1.
Fixed Equipment, Spacing or Sealing.
Allows accessibility for cleaning on all sides, above, and underneath
5
the units or minimizes the need for cleaning due to closely abutted
6
surfaces;
7
2.
Ensures that equipment that is subject to moisture is sealed;
8
3.
Prevents the harborage of insects and rodents; and
9
4.
Provides accessibility for the monitoring of pests.
10
4-402.12
Fixed Equipment, Elevation or Sealing.
11
The inability to adequately or effectively clean areas under equipment could create
12
a situation that may attract insects and rodents and accumulate
13
microorganisms that are transmissible through food.
14
The effectiveness of cleaning is directly affected by the ability to access all areas to
15
clean fixed equipment. It may be necessary to elevate the equipment. When
16
elevating equipment is not feasible or prohibitively expensive, sealing to prevent
17
contamination is required.
18
The economic impact of the requirement to elevate display units in retail food stores,
19
coupled with the fact that the design, weight, and size of such units are not
20
conducive to casters or legs, led to the exception for certain units located in
21
consumer shopping areas, provided the floor under the units is kept clean. This
22
exception for retail food store display equipment including shelving, refrigeration,
Guam Food Code Annex 1 – Public Health Reasons
219
pathogenic
1
and freezer units in the consumer shopping areas requires a rigorous cleaning
2
schedule.
3
Equipment 4-501.11
4
Proper maintenance of equipment to manufacturer specifications helps ensure that
5
it will continue to operate as designed. Failure to properly maintain equipment
6
could lead to violations of the associated requirements of the Code that place the
7
health of the consumer at risk. For example, refrigeration units in disrepair may no
8
longer be capable of properly cooling or holding potentially hazardous
9
(time/temperature control for safety) foods at safe temperatures.
Good Repair and Proper Adjustment.
10
The cutting or piercing parts of can openers may accumulate metal fragments that
11
could lead to food containing foreign objects and, possibly, result in consumer
12
injury.
13
Adequate cleaning and sanitization of dishes and utensils using a warewashing
14
machine is directly dependent on the exposure time during the wash, rinse, and
15
sanitizing cycles. Failure to meet manufacturer and Code requirements for cycle
16
times could result in failure to clean and sanitize. For example, high temperature
17
machines depend on the buildup of heat on the surface of dishes to accomplish
18
sanitization. If the exposure time during any of the cycles is not met, the
19
surface of the items may not reach the time-temperature parameter required for
20
sanitization. Exposure time is also important in warewashing machines that use
21
a chemical sanitizer since the sanitizer must contact the items long enough for
22
sanitization to occur. In addition, a chemical sanitizer will not sanitize a dirty dish;
Guam Food Code Annex 1 – Public Health Reasons
220
1
therefore, the cycle times during the wash and rinse phases are critical to
2
sanitization.
3
4-501.12
Cutting Surfaces.
4
Cutting surfaces such as cutting boards and blocks that become scratched and
5
scored may be difficult to clean and sanitize.
6
microorganisms transmissible through food may build up or accumulate. These
7
microorganisms may be transferred to foods that are prepared on such surfaces.
As a result, pathogenic
8
9
4-501.13
Microwave Ovens.
10
Failure of microwave ovens to meet the CFR standards could result in human
11
exposure to radiation leakage, resulting in possible medical problems to consumers
12
and employees using the machines.
13
4-501.14
Warewashing Equipment, Cleaning Frequency.
14
With the passage of the Food Quality Protection Act of 1996 and the related
15
Antimicrobial Regulation Technical Correction Act of 1998, federal regulatory
16
responsibility for chemical hard surface sanitizers was moved from FDA
17
(CFSAN/OFAS) to EPA (Office of Pesticides Programs, Antimicrobial Division).
18
As a result, the relevant Federal regulation has moved from 21 CFR 178.1010
19
to 40 CFR 180.940.
20
During operation, warewashing equipment is subject to the accumulation of
21
food wastes and other soils or sources of contamination. In order to ensure the
22
proper cleaning and sanitization of equipment and utensils, it is necessary to clean
Guam Food Code Annex 1 – Public Health Reasons
221
1
the surface of warewashing equipment before use and periodically throughout the
2
day.
3
With respect to chemical sanitization, section 4-501.114 addresses the proper
4
make-up of the sanitizing solution, i.e., chemical concentration, pH, and temperature
5
at the required minimum levels specified when considered together and, with
6
respect to quaternary ammonium compounds (quats), the maximum hardness level.
7
If these minimums (maximum hardness) are not as specified, then this provision
8
is violated.
9
By contrast, paragraph 4-703.11(C) addresses exposure time in seconds. For
10
chemical sanitization, this paragraph is only violated when the specified exposure
11
time is not met.
12
Section 7-204.11 addresses two additional considerations. The first is whether
13
or not the chemical agent being applied as a sanitizer is approved and listed for that
14
use under 40 CFR 180.940. If the chemical used is not thus listed, this section is
15
violated.
16
The second consideration under this section is whether the product, if approved and
17
listed, is being used in accordance with the “Limits” provided for that product
18
under its 40 CFR 180.940 listing. The concern here is an indirect food additives
19
concern, since chemical sanitizing solutions are not rinsed off in this country. For
20
example, 40 CFR 180.940(a) lists several quaternary ammonium compounds as
21
approved for “food-contact surfaces in public eating places, dairy-processing
22
equipment, and food-processing equipment and utensils,” each listing adding a Limit
23
that states, “When ready for use, the end-use concentration of all
Guam Food Code Annex 1 – Public Health Reasons
222
quaternary
1
chemicals in the solution is not to exceed 200 ppm of active quaternary compound.
2
If a sanitarian determined that a solution of any of these quats was at 600 ppm,
3
section 7-204.11 would be violated.
4
To summarize, a too weak sanitizing solution would be a violation of section
5
4- 501.114. A too strong solution would be a violation of section 7-204.11. Section
6
7-202.12 would not be violated due to the existence of section 7-204.11 that
7
specifically addresses the use chemical sanitizers.
8
4-501.15
9
Warewashing Machines, Manufacturers'
Operating Instructions.
10
To ensure properly cleaned and sanitized equipment and utensils, warewashing
11
machines must be operated properly. The manufacturer affixes a data plate to
12
the machine providing vital, detailed instructions about the proper operation of
13
the
14
temperatures which must be achieved.
15
machine
including
4-501.16
wash,
rinse, and
sanitizing
cycle
times
and
Warewashing Sinks, Use Limitation.
16
If the wash sink is used for functions other than warewashing, such as washing
17
wiping cloths or washing and thawing foods, contamination of equipment and
18
utensils could occur.
Guam Food Code Annex 1 – Public Health Reasons
223
1
4-501.17
Warewashing Equipment, Cleaning Agents.
2
Failure to use detergents or cleaners in accordance with the manufacturer's
3
label instructions could create safety concerns for the employee and consumer. For
4
example, employees could suffer chemical burns, and chemical residues could
5
find their way into food if detergents or cleaners are used carelessly.
6
Equipment or utensils may not be cleaned if inappropriate or insufficient
7
amounts of cleaners or detergents are used.
8
4-501.18
Warewashing Equipment, Clean Solutions.
9
Failure to maintain clean wash, rinse, and sanitizing solutions adversely affects
10
the warewashing operation. Equipment and utensils may not be sanitized,
11
resulting in subsequent contamination of food.
12
4-501.19
13
The wash solution temperature required in the Code is essential for removing
14
organic matter. If the temperature is below 110oF, the performance of the detergent
15
may be adversely affected, e.g., animal fats that may be present on the
16
dirty dishes would not be dissolved.
17
Manual Warewashing Equipment, Wash Solution Temperature.
4-501.110
18
Mechanical Warewashing Equipment, Wash
Solution Temperature.
19
The wash solution temperature in mechanical warewashing equipment is
20
critical to proper operation. The chemicals used may not adequately perform their
21
function if the temperature is too low. Therefore, the manufacturer's instructions
22
must be followed. The temperatures vary according to the specific equipment being
23
used.
Guam Food Code Annex 1 – Public Health Reasons
224
1
4-501.111
2
Manual Warewashing Equipment, Hot Water
Sanitization Temperatures.*
3
If the temperature during the hot water sanitizing step is less than 77oC
4
(171oF), sanitization will not be achieved. As a result, pathogenic organisms
5
may survive and be subsequently transferred from utensils to food.
6
4-501.112
7
Mechanical Warewashing Equipment, Hot Water Sanitization
Temperatures.
8
The temperature of hot water delivered from a warewasher sanitizing rinse
9
manifold must be maintained according to the equipment manufacturer’s
10
specifications and temperature limits specified in this section to ensure surfaces
11
of multiuse utensils such as kitchenware and tableware accumulate enough heat
12
to destroy pathogens that may remain on such surfaces after cleaning.
13
The surface temperature must reach at least 71ºC (160ºF) as measured by an
14
irreversible registering temperature measuring device to affect sanitization. When
15
the sanitizing rinse temperature exceeds 90ºC (194ºF) at the manifold, the
16
water becomes volatile and begins to vaporize reducing its ability to convey
17
sufficient heat to utensil surfaces. The lower temperature limits of 74ºC (165ºF)
18
for a stationary rack, single temperature machine, and 82ºC (180ºF) for other
19
machines are based on the sanitizing rinse contact time required to achieve
20
the 71ºC (160ºF) utensil surface temperature.
21
4-501.113
Mechanical Warewashing Equipment, Sanitization Pressure.
22
If the flow pressure of the final sanitizing rinse is less than that required, dispersion
23
of the sanitizing solution may be inadequate to reach all surfaces of
Guam Food Code Annex 1 – Public Health Reasons
225
1
equipment or utensils.
2
4-501.114
3
Manual and Mechanical Warewashing Equipment, Chemical
Sanitization - Temperature, pH, Concentration, and Hardness.*
4
With the passage of the Food Quality Protection Act of 1996 and the related
5
Antimicrobial Regulation Technical Correction Act of 1998, Federal regulatory
6
responsibility for chemical hard surface sanitizers was moved from FDA
7
(CFSAN/OFAS) to EPA (Office of Pesticides Programs, Antimicrobial Division).
8
As a result, the relevant Federal regulation has moved from 21 CFR 178.1010
9
to 40 CFR 180.940.
10
The effectiveness of chemical
sanitizers can be directly affected by the
11
temperature, pH, concentration of the sanitizer solution used, and hardness of the
12
water. All sanitizers approved for use under 40 CFR 180.940 must be used under
13
water conditions stated on the label to ensure efficacy. Therefore, it is critical to
14
sanitization that the sanitizers are used properly and the solutions meet the
15
minimum standards required in the Code.
16
With respect to chemical sanitization, section 4-501.114 addresses the proper
17
make-up of the sanitizing solution, i.e., chemical concentration, pH, and temperature
18
at the required maximum levels specified when considered together and, with
19
respect to quaternary ammonium compounds (quats), the maximum hardness level.
20
If these minimums (maximum hardness) are not as specified, then this provision is
21
violated.
22
By contrast, paragraph 4-703.11(C) addresses exposure time in seconds. For
23
chemical sanitization, this paragraph is only violated when the specified exposure
Guam Food Code Annex 1 – Public Health Reasons
226
1
time is not met.
2
Section 7-204.11 addresses two additional considerations. The first is whether or
3
not the chemical agent being applied as a sanitizer is approved and listed for
4
that use under 40 CFR 180.940. If the chemical used is not thus listed, this
5
section is violated.
6
The second consideration under this section is whether the product, if
7
approved and listed, is being used in accordance with the “Limits” provided for
8
that product under its 40 CFR 180.940 listing. The concern here is an indirect
9
food additives concern, since chemical sanitizing solutions are not rinsed off in this
10
country. For example, 40 CFR 180.940(a) lists several quaternary ammonium
11
compounds as approved for “food-contact surfaces in public eating places,
12
dairy-processing equipment, and food-processing equipment and utensils,” each
13
listing adding a Limit that states, “When ready for use, the end-use
14
concentration of all quaternary chemicals in the solution is not to exceed
15
200 ppm of active quaternary compound.” If a sanitarian determined that a
16
solution of any of these quats was at 600 ppm, section 7-204.11 would be
17
violated.
18
To summarize, a too weak sanitizing solution would be a violation of section 4-
19
501.114. A too strong solution would be a violation of section 7-204.11. Section 7-
20
202.12 would not be violated due to the existence of section 7-204.11 that
21
specifically addresses the use chemical sanitizers.
22
23
4-501.115
Manual Warewashing Equipment, Chemical
Sanitization Using Detergent-Sanitizers.
Guam Food Code Annex 1 – Public Health Reasons
227
1
Some chemical sanitizers are not compatible with detergents when a 2 compartment
2
operation is used. When using a sanitizer that is different from the detergent-
3
sanitizer of the wash compartment, the sanitizer may be inhibited by carry-over,
4
resulting in inadequate sanitization.
5
4-501.116
6
Warewashing Equipment, Determining Chemical Sanitizer
Concentration.
7
The effectiveness of chemical sanitizers is determined primarily by the concentration
8
and pH of the sanitizer solution. Therefore, a test kit is necessary to
9
accurately determine the concentration of the chemical sanitizer solution.
10
Utensils and
11
Temperature
12
and Pressure
13
Measuring Devices
14
A utensil or food temperature measuring device can act as a source of
15
contamination to the food it contacts if it is not maintained in good repair.
16
Also, if temperature or pressure measuring devices are not maintained in good
17
repair, the accuracy of the readings is questionable. Consequently, a temperature
18
problem may not be detected, or conversely, a corrective action may be
19
needlessly taken.
20
4-502.12
4-502.11
Good Repair and Calibration.
Single-Service and Single-Use Articles, Required Use.*
21
In situations in which the reuse of multiuse items could result in foodborne illness to
22
consumers, single-service and single-use articles must be used to ensure safety.
Guam Food Code Annex 1 – Public Health Reasons
228
1
4-502.13
2
Single-Service and Single-Use Articles, Use
Limitation.
3
Articles that are not constructed of multiuse materials may not be reused as they
4
are unable to withstand the rigors of multiple uses, including the ability to be
5
subjected to repeated washing, rinsing, and sanitizing.
6
4-502.14
Shells, Use Limitation.
7
The reuse of mollusk and crustacean shells as multiuse utensils is not allowed
8
in food establishments. This prohibition does not apply to the removal of the oyster
9
or other species from the shell for preparation, then returning the same animal to the
10
same shell for service.
11
The shell itself may be potentially unsafe for use as a food utensil because of
12
residues from natural and environmental contamination occurring after the mollusk
13
or crustacean is removed. In addition, natural shells are not durable or easily
14
cleanable as specified under section 4-502.13. When mollusk or crustacean
15
shells (from commercial sources) are re-used by filling them with shucked shellfish,
16
the food is considered misleading and not honestly presented.
17
Objective
4-601.11
18
Equipment, Food-Contact Surfaces, NonfoodContact Surfaces, and Utensils.*
19
The objective of cleaning focuses on the need to remove organic matter from
20
food-contact surfaces so that sanitization can occur and to remove soil from nonfood
21
contact surfaces so that pathogenic microorganisms will not be allowed to
22
accumulate and insects and rodents will not be attracted.
23
Frequency 4-602.11
Equipment Food-Contact Surfaces and Utensils.*
Guam Food Code Annex 1 – Public Health Reasons
229
1
Microorganisms may be transmitted from a food to other foods by utensils,
2
cutting boards, thermometers, or other food-contact surfaces.
3
surfaces and equipment used for potentially hazardous (time/temperature control
4
for safety) foods should be cleaned as needed throughout the day but must
5
be
6
microorganisms on those surfaces.
7
Refrigeration
8
pathogens, making it unnecessary to clean every four hours. However, the time
9
period between cleaning equipment and utensils may not exceed 24 hours. A time-
10
temperature chart is provided in subparagraph 4-602.11(D)(2) to accommodate
11
operations that use equipment and utensils in a refrigerated room or area that
12
maintains a temperature between 41oF or less and 55oF.
13
Surfaces of utensils and equipment contacting food that is not potentially hazardous
14
(time/temperature
15
carbonated beverage dispenser nozzles, beverage dispensing circuits or lines,
16
water vending equipment, coffee bean grinders, ice makers, and ice bins must
17
be cleaned on a routine basis to prevent the development of slime, mold, or soil
18
residues that may contribute to an accumulation of microorganisms.
19
equipment manufacturers and industry associations, e.g., within the tea industry,
20
develop guidelines for regular cleaning and sanitizing of equipment. If the
21
manufacturer does not provide cleaning specifications for food-contact surfaces
22
of equipment that are not readily visible, the person in charge should develop a
cleaned
no
less than every 4
temperatures
control
slow down
for
hours
to prevent
the
the
generation
time of bacterial
safety food) such as
Guam Food Code Annex 1 – Public Health Reasons
230
Food-contact
growth
of
iced tea dispensers,
Some
1
cleaning regimen that is based on the soil that may accumulate in those
2
particular items of equipment.
3
Regarding the possible adulteration from one species of meat to another
4
between cleaning of food-contact surfaces, USDA/FSIS does not automatically
5
consider species adulteration as a health hazard. FSIS stated in an Advance
6
Notice of Proposed Rulemaking that species adulteration falls into a gray area
7
between safety and economic adulteration (65 FR 14486, March 17, 2000, Other
8
Consumer Protection Activities). FSIS will review public comments received on
9
the species adulteration issue and further review the scientific literature and risk
10
assessment mechanisms before declaring species adulteration a health hazard.
11
Meanwhile, species adulteration is generally considered by FSIS as an
12
economic issue. However, investigations by FSIS of species adulteration
13
incidents
14
adulteration as a health hazard on a case-by-case basis.
15
may include a determination
4-602.12
regarding
the
impact
of
species
Cooking and Baking Equipment.
16
Food-contact surfaces of cooking equipment must be cleaned to prevent
17
encrustations that may impede heat transfer necessary to adequately cook
18
food. Encrusted equipment may also serve as an insect attractant when not in
19
use. Because of the nature of the equipment, it may not be necessary to clean
20
cooking equipment as frequently as the equipment specified in § 4-602.11.
21
4-602.13
Nonfood-Contact Surfaces.
22
The presence of food debris or dirt on nonfood contact surfaces may provide
23
a suitable environment for the growth of microorganisms which employees may
Guam Food Code Annex 1 – Public Health Reasons
231
1
inadvertently transfer to food. If these areas are not kept clean, they may also
2
provide harborage for insects, rodents, and other pests.
3
Methods
4
Dry cleaning methods are indicated in only a few operations, which are
5
limited to dry foods that are not potentially hazardous (time/temperature control
6
for safety foods). Under some circumstances, attempts at wet cleaning may
7
create microbiological concerns.
4-603.11
8
9
Dry Cleaning.
4-603.12
Precleaning.
Precleaning of utensils, dishes, and food equipment allows for the removal of
10
grease and food debris to facilitate the cleaning action of the detergent. Depending
11
upon the condition of the surface to be cleaned, detergent alone may not be
12
sufficient to loosen soil for cleaning. Heavily soiled surfaces may need to be
13
presoaked or scrubbed with an abrasive.
14
4-603.13
Loading of Soiled Items, Warewashing Machines.
15
Items to be washed in a warewashing machine must receive unobstructed
16
exposure to the spray to ensure adequate cleaning. Items which are stacked
17
or trays which are heavily loaded with silverware cannot receive complete
18
distribution of detergent, water, or sanitizer and cannot be considered to be
19
clean. 4-603.14
Wet Cleaning.
Guam Food Code Annex 1 – Public Health Reasons
232
1
Because of the variety of cleaning agents available and the many different types
2
of soil to be removed it is not possible to recommend one cleaning agent to fit
3
all situations. Each of the different types of cleaners works best under different
4
conditions (i.e., some work best on grease, some work best in warm water, others
5
work best in hot water). The specific chemical selected should be compatible
6
with any other chemicals to be used in the operation such as a sanitizer or
7
drying agent.
8
9
4-603.15
Washing, Procedures for Alternative Manual
Warewashing Equipment.
10
Some pieces of equipment are fixed or too large to be cleaned in a sink.
11
Nonetheless, cleaning of such equipment requires the application of cleaners
12
for the removal of soil and rinsing for the removal of abrasive and cleaning
13
chemicals, followed by sanitization.
14
4-603.16
Rinsing Procedures.
15
It is important to rinse off detergents, abrasive, and food debris after the wash step
16
to avoid diluting or inactivating the sanitizer.
17
4-603.17
Returnables, Cleaning for Refilling.*
18
The refilling of consumer-owned beverage containers introduces the possibility
19
of contamination of the filling equipment or product by improperly cleaned containers
20
or the improper operation of the equipment. To prevent this contamination and
21
possible health hazards to the consumer, the refilling of consumer-owned containers
22
is limited to beverages that are not potentially hazardous (time/temperature control
Guam Food Code Annex 1 – Public Health Reasons
233
1
for safety) foods. Equipment must be designed to prevent the contamination of the
2
equipment and means must be provided to clean the containers at the facility.
3
Objective
4
Effective sanitization procedures destroy organisms of public health importance that
5
may be present on wiping cloths, food equipment, or utensils after cleaning, or
6
which have been introduced into the rinse solution. It is important that surfaces be
7
clean before being sanitized to allow the sanitizer to achieve its maximum benefit.
4-701.10
Food-Contact Surfaces and Utensils.
8
9
Frequency 4-702.11
Before Use After Cleaning.*
10
Sanitization is accomplished after the warewashing steps of cleaning and
11
rinsing so that utensils and food-contact surfaces are sanitized before coming
12
in contact with food and before use.
13
Methods
14
Efficacious sanitization depends on warewashing being conducted within certain
15
parameters. Time is a parameter applicable to both chemical and hot water
16
sanitization. The time hot water or chemicals contact utensils or food-contact
17
surfaces must be sufficient to destroy pathogens that may remain on surfaces after
18
cleaning. Other parameters, such as rinse pressure, temperature, and chemical
19
concentration are used in combination with time to achieve sanitization.
20
When surface temperatures of utensils passing through warewashing machines
21
using hot water for sanitizing do not reach the required 71ºC (160ºF), it is
22
important to understand the factors affecting the decreased surface temperature.
23
A comparison should be made between the machine manufacturer’s operating
4-703.11
Hot Water and Chemical.*
Guam Food Code Annex 1 – Public Health Reasons
234
1
instructions and the machine’s actual wash and rinse temperatures and final rinse
2
pressure. The actual temperatures and rinse pressure should be consistent with the
3
machine manufacturer’s operating instructions and within limits specified in §§ 4-
4
501.112 and 4-501.113.
5
If either the temperature or pressure of the final rinse spray is higher than the
6
specified upper limit, spray droplets may disperse and begin to vaporize
7
resulting in less heat delivery to utensil surfaces. Temperatures below the specified
8
limit will not convey the needed heat to surfaces. Pressures below the specified
9
limit will result in incomplete coverage of the heat-conveying sanitizing rinse
10
across utensil surfaces.
11
Objective
12
Linens that are not free from food residues and other soiling matter may carry
13
pathogenic microorganisms that may cause illness.
14
4-801.11
Clean Linens.
Frequency 4-802.11
Specifications.
15
Linens, cloth gloves, and cloth napkins are to be laundered between uses to
16
prevent the transfer of pathogenic microorganisms between foods or to food-contact
17
surfaces. The laundering of wet wiping cloths before being used with a fresh
18
solution of cleanser or sanitizer is designed to reduce the microbiological
19
load in the cleanser and sanitizer and thereby reduce the possible transfer of
20
microorganisms to food and nonfood-contact surfaces.
21
Methods
4-803.11
Storage of Soiled Linens.
Guam Food Code Annex 1 – Public Health Reasons
235
1
Soiled linens may directly or indirectly contaminate food. Proper storage will reduce
2
the possibility of contamination of food, equipment, utensils, and single-service and
3
single-use articles.
4
4-803.12
Mechanical Washing.
5
Proper laundering of wiping cloths will significantly reduce the possibility that
6
pathogenic microorganisms will be transferred to food, equipment, or utensils.
7
4-803.13
Use of Laundry Facilities.
8
Washing and drying items used in the operation of the establishment on the
9
premises will help prevent the introduction of pathogenic microorganisms into
10
the environment of the food establishment.
11
Drying
12
Items must be allowed to drain and to air-dry before being stacked or stored.
13
Stacking wet items such as pans prevents them from drying and may allow an
14
environment
15
equipment and utensils is
16
microorganisms to equipment or utensils.
17
4-901.11
where
Equipment and Utensils, Air-Drying Required.
microorganisms
4-901.12
can begin
prohibited to
prevent
to
grow.
Cloth drying of
the possible transfer of
Wiping Cloths, Air-Drying Locations.
18
Cloths that are air-dried must be dried so that they do not drip on food or utensils
19
and so that the cloths are not contaminated while air-drying.
20
Lubricating and
21
Reassembling
4-902.11
Food-Contact Surfaces.
Guam Food Code Annex 1 – Public Health Reasons
236
1
Food-contact surfaces must be lubricated in a manner that does not introduce
2
contaminants to those surfaces.
3
4-902.12
Equipment.
4
Equipment must be reassembled in a way that food-contact surfaces are not
5
contaminated.
6
Storing
4-903.11
7
Equipment, Utensils, Linens, and SingleService and Single-Use Articles.
8
Clean equipment and multiuse utensils which have been cleaned and sanitized,
9
laundered linens,
and single-service and single-use articles can become
10
contaminated before their intended use in a variety of ways such as through water
11
leakage, pest infestation, or other insanitary condition.
12
4-903.12
Prohibitions.
13
The improper storage of clean and sanitized equipment, utensils, laundered linens,
14
and single-service and single-use articles may allow contamination before their
15
intended use. Contamination can be caused by moisture from absorption, flooding,
16
drippage, or splash. It can also be caused by food debris, toxic materials, litter,
17
dust, and other materials.
18
employee practices, unacceptable high-risk storage locations, or improper
19
construction of storage facilities.
20
Preventing
4-904.11
Kitchenware and Tableware.
21
Contamination
4-904.12
Soiled and Clean Tableware.
4-904.13
Preset Tableware.
22
The contamination is often related to unhygienic
Guam Food Code Annex 1 – Public Health Reasons
237
1
The presentation or setting of single-service and single-use articles and cleaned and
2
sanitized utensils shall be done in a manner designed to prevent the contamination
3
of food- and lip-contact surfaces.
4
5
Chapter 5 Water, Plumbing, and Waste
6
Source
7
Water, unless it comes from a
8
contamination for food, equipment, utensils, and hands. The major concern is that
9
water may become a vehicle for transmission of disease organisms. Water can
10
also become contaminated with natural or man-made chemicals. Therefore, for
11
the protection of consumers and employees, water must be obtained from a source
12
regulated by law and must be used, transported, and dispensed in a sanitary
13
manner.
14
5-101.11
5-101.12
Approved System.*
safe
supply, may serve as a source of
System Flushing and Disinfection.*
15
During construction, repair, or modification, water systems may become
16
contaminated with microbes from soil because pipes are installed underground or
17
by chemicals resulting from soldering and welding. Floods and other incidents
18
may also cause water to become contaminated. Chemical contaminants such as
19
oils may also be present on or in the components of the system. To render the
20
water safe, the system must be properly flushed and disinfected before being placed
21
into service.
22
5-101.13
Bottled Drinking Water.*
Guam Food Code Annex 1 – Public Health Reasons
238
1
Bottled water is obtained from a public water system or from a private source
2
such as a spring or well. Either means of production must be controlled by public
3
health law to protect the consumer from contaminated water.
4
Quality
5
Bacteriological and chemical standards have been developed for public
6
drinking water supplies to protect public health. All drinking water supplies must
7
meet standards required by law.
8
9
5-102.11
Standards.*
5-102.12
Nondrinking Water.*
Food establishments may use nondrinking water for purposes such as air-
10
conditioning or fire protection.
11
bacteriological or chemical quality or safety as is drinking water. Consequently,
12
certain safety precautions must be observed to prevent the contamination of food,
13
drinking water, or food-contact surfaces. Identifying the piping designated as
14
nondrinking waterlines and inspection for cross connections are examples of safety
15
precautions.
16
Nondrinking
5-102.13
water is not monitored for
Sampling.
17
Wells and other types of individual water supplies may become contaminated
18
through faulty equipment or environmental contamination of ground water. Periodic
19
sampling is required by law to monitor the safety of the water and to detect any
20
change in quality. The controlling agency must be able to ascertain that this
21
sampling program is active and that the safety of the water is in conformance with
22
the appropriate standards. Laboratory results are only as accurate as the sample
23
submitted. Care must be taken not to contaminate samples. Proper sample
Guam Food Code Annex 1 – Public Health Reasons
239
1
collection and timely transportation to the laboratory are necessary to ensure the
2
safety of drinking water used in the establishment.
3
5-102.14
Sample Report.
4
The most recent water sampling report must be kept on file to document a safe
5
water supply.
6
Quantity and
7
Availability
8
Availability of sufficient water is a basic requirement for proper sanitation within
9
a food establishment.
5-103.11
Capacity.*
An insufficient supply of safe water will prevent the
10
proper cleaning of items such as equipment and utensils and of food employees'
11
hands.
12
Hot water required for washing items such as equipment and utensils and
13
employees' hands, must be available in sufficient quantities to meet demand during
14
peak water usage periods. Booster heaters for warewashers that use hot
15
water for sanitizing are designed to raise the temperature of hot water to a level
16
that ensures sanitization. If the volume of water reaching the booster heater is
17
not sufficient or hot enough, the required temperature for sanitization can not be
18
reached. Manual washing of food equipment and utensils is most effective when
19
hot water is used. Unless utensils are clean to sight and touch, they cannot be
20
effectively sanitized.
21
5-103.12
Pressure.
22
Inadequate water pressure could lead to situations that place the public health at
23
risk. For example, inadequate pressure could result in improper handwashing
Guam Food Code Annex 1 – Public Health Reasons
240
1
or equipment operation. Sufficient water pressure ensures that equipment such
2
as mechanical warewashers operate according to manufacturer's specifications.
3
Distribution,
4
Delivery, and Retention
5
Inadequate water systems may serve as vehicles for contamination of food or
6
food- contact surfaces. This requirement is intended to ensure that sufficient
7
volumes of water are provided from supplies shown to be safe, through a distribution
8
system which is protected.
5-104.11
9
5-104.12
System.
Alternative Water Supply.
10
Water
from an approved source
11
conveyed. Improperly constructed and maintained water mains, pumps, hoses,
12
connections, and other appurtenances,
13
containers, may result in contamination of safe water and render it hazardous to
14
human health.
15
Materials
16
Plumbing systems and hoses conveying water must be made of approved
17
materials and be smooth, durable, nonabsorbent, and corrosion-resistant. If not,
18
the system may constitute a health hazard because unsuitable surfaces may
19
harbor disease organisms or it may be constructed of materials that may,
20
themselves, contaminate the water supply.
21
Design,
22
Construction,
23
and Installation
5-201.11
5-202.11
can
be
contaminated if inappropriately
as well as transport vehicles and
Approved.*
Approved System and Cleanable Fixtures.*
Guam Food Code Annex 1 – Public Health Reasons
241
1
Water within a system will leach minute quantities of materials out of the
2
components of the system. To make sure none of the leached matter is toxic
3
or in a form that may produce detrimental effects, even through long-term use,
4
all materials and components used in water systems must be of an approved
5
type.
6
current standards.
7
Improperly designed, installed, or repaired water systems can have inherent
8
deficiencies such as improper access openings, dead spaces, and areas
9
difficult or impossible to clean and disinfect. Dead spaces allow water quality
New or replacement items must be tested and approved based on
10
to degrade since
they are out of the constant circulation of the system.
11
Fixtures such as warewashing sinks that are not easily cleanable may lead to
12
the contamination of food products.
13
5-202.12
14
Warm water is more effective than cold water in removing the fatty soils encountered
15
in kitchens. An adequate flow of warm water will cause soap to lather and aid
16
in flushing soil quickly from the hands. ASTM Standards for testing the efficacy
17
of handwashing formulations specify a water temperature of 40°C + 2°C (100 to
18
108°F).
19
An inadequate flow or temperature of water may lead to poor handwashing practices
20
by food employees. A mixing valve or combination faucet is needed to
21
provide properly tempered water for handwashing. Steam mixing valves are
22
not allowed for this use because they are hard to control and injury by
23
scalding is a possible hazard.
Handwashing Facility, Installation.
Guam Food Code Annex 1 – Public Health Reasons
242
1
5-202.13
Backflow Prevention, Air Gap.*
2
During periods of extraordinary demand, drinking water systems may develop
3
negative pressure in portions of the system. If a connection exists between the
4
system and a source of contaminated water during times of negative pressure,
5
contaminated water may be drawn into and foul the entire system. Standing
6
water in sinks, dipper wells, steam kettles, and other equipment may become
7
contaminated with cleaning chemicals
8
introduction of this liquid into the water supply through back siphonage, various
9
means may be used.
or
food residue.
To
prevent
the
10
The water outlet of a drinking water system must not be installed so that it contacts
11
water in sinks, equipment, or other fixtures that use water. Providing an air gap
12
between the water supply outlet and the flood level rim of a plumbing fixture or
13
equipment prevents contamination that may be caused by backflow.
14
5-202.14
Backflow Prevention Device, Design Standard.
15
In some instances an air gap is not practical such as is the case on the lower
16
rinse arm for the final rinse of warewashers. This arm may become submerged if
17
the machine drain becomes clogged. If this failure occurs, the machine tank would
18
fill to the flood level rim, which is above the rinse arm. A backflow prevention
19
device is used to avoid potential backflow of contaminated water when an air gap
20
is not practical. The device provides a break to the atmosphere in the event of
21
a negative pressure within the system.
22
particulate matter carried in water may coat moving parts of the device or
23
become lodged between them over time.
Minerals contained in water and solid
This may render the device
Guam Food Code Annex 1 – Public Health Reasons
243
1
inoperative.
To minimize such an occurrence, only devices meeting certain
2
standards of construction, installation, maintenance, inspection, and testing for
3
that application may be used. The necessary maintenance can be facilitated by
4
installing these devices in accessible locations.
5
5-202.15
Conditioning Device, Design.
6
Water conditioning devices must be designed for easy disassembly for servicing
7
so that they can be maintained in a condition that allows them to perform the
8
function for which they were designed.
9
Numbers and
5-203.11
Handwashing Facilities.*
10
Capacities
11
Because handwashing is such an important factor in the prevention of foodborne
12
illness, sufficient facilities must be available to make handwashing not only
13
possible, but likely.
14
5-203.12
Toilets and Urinals.*
15
Adequate, sanitary toilet facilities are necessary for the proper disposal of
16
human waste, which carries pathogenic microorganisms, and for preventing
17
the spread of disease by flies and other insects.
18
Toilet facilities must be of sanitary design and kept clean and in good repair to
19
prevent food contamination and to motivate employees to use sanitary practices
20
in the establishment.
21
5-203.13
Service Sink.
22
Mop water and similar liquid wastes are contaminated with microorganisms and
23
other filth. Waste water must be disposed of in a sanitary manner that will not
Guam Food Code Annex 1 – Public Health Reasons
244
1
contaminate food or food equipment. A service sink or curbed cleaning facility
2
with a drain allows for such disposal.
3
5-203.14
Backflow Prevention Device, When Required.*
4
The delivery end of hoses attached to hose bibbs on a drinking water line may
5
be dropped into containers filled with contaminated water or left in puddles on
6
the floor or in other possible sources of contamination. A backflow prevention
7
device must be installed on the hose bibb to prevent the back siphonage of
8
contaminated liquid into the drinking water system during occasional periods of
9
negative pressure in the water line.
10
5-203.15
Backflow Prevention Device, Carbonator.*
11
When carbon dioxide is mixed with water, carbonic acid, a weak acid, is
12
formed.
13
Carbonators on soft drink dispensers form such acids as they carbonate the water
14
to be mixed with the syrups to produce the soft drinks.
15
backs up into a copper water line, carbonic acid will dissolve some of the
16
copper. The water containing the dissolved copper will subsequently be used
17
in dispensing soft drinks and the first few customers receiving the drinks are
18
likely to suffer with the symptoms of copper poisoning.
19
An air gap or a vented backflow prevention device meeting ASSE Standard
20
No. 1022 will prevent this occurrence, thereby reducing incidences of copper
21
poisoning.
Guam Food Code Annex 1 – Public Health Reasons
245
If carbon dioxide
1
Location and
2
Placement
3
Hands are probably the most common vehicle for the transmission of pathogens
4
to foods in an establishment. Hands can become soiled with a variety of
5
contaminants during routine operations. Some employees are unlikely to wash
6
their hands unless properly equipped handwashing facilities are accessible in
7
the immediate work area. Facilities which are improperly located may be blocked
8
by portable equipment or stacked full of soiled utensils and other items, rendering
9
the facility unavailable for regular employee use. Nothing must block the
10
approach to a handwashing facility thereby discouraging its use, and the facility
11
must be kept clean and well stocked with soap and sanitary towels to
12
encourage frequent use.
13
5-204.11
5-204.12
Handwashing Sinks.*
Backflow Prevention Device, Location.
14
Backflow prevention devices are meant to protect the drinking water system
15
from contamination caused
16
prevention devices will not work. If inconveniently located, these devices
17
may not be accessed when systems are extended, altered, serviced, or replaced.
18
Over a period of time, unserviced devices may fail and system contamination
19
may occur.
20
5-204.13
21
When not located for easy maintenance, conditioning devices will be inconvenient
22
to access and devices such as filters, screens, and water softeners will become
23
clogged because they are not properly serviced.
by
backflow.
If
improperly placed, backflow
Conditioning Device, Location.
Guam Food Code Annex 1 – Public Health Reasons
246
1
Operation and
2
Maintenance
3
Facilities must be maintained in a condition that promotes handwashing and
4
restricted for that use.
5
encourages timely handwashing which provides a break in the chain of
6
contamination from the hands of food employees to food or food-contact surfaces.
7
Sinks used for food preparation and warewashing can become sources of
8
contamination if used as handwashing facilities by employees returning from the
9
toilet or from duties which have contaminated their hands.
10
5-205.11
5-205.12
Using a Handwashing Sink.
Convenient accessibility of a handwashing facility
Prohibiting a Cross Connection.*
11
Nondrinking water may be of unknown or questionable origin. Waste water is
12
either known or suspected to be contaminated. Neither of these sources can be
13
allowed to contact and contaminate the drinking water system.
14
5-205.13
15
Water system devices, such as filters and backflow preventers, are affected by
16
the water in the system. How devices are affected depends on water quality,
17
especially pH, hardness, and
18
Complexity of the device is also a factor. Manufacturer recommendations, as
19
well as inspection and maintenance schedules for these devices, must be strictly
20
followed to prevent failure during operation.
21
Cleaning
22
Scheduling Inspection and Service for a Water System Device.
5-205.14
suspended particulate matter in the water.
Water Reservoir of Fogging
Devices, Cleaning.*
Guam Food Code Annex 1 – Public Health Reasons
247
1
Water reservoirs that have poor water exchange rates, such as reservoirs for
2
some humidifiers or aerosol or fogging devices, and that are directly or indirectly
3
open to the atmosphere, may be contaminated with respiratory pathogens such
4
as Legionella pneumophila. This organism is extremely infectious and can be
5
transmitted through very small droplets of a fogger or humidifier. It is important
6
that the manufacturer's cleaning and maintenance schedule be scrupulously
7
followed to prevent a reservoir from colonization by this bacterium.
8
9
5-205.15
System Maintained in Good Repair.*
Improper repair or maintenance of any portion of the plumbing system may
10
result
in potential health hazards such
11
leakage. These conditions may result in the contamination of food, equipment,
12
utensils, linens, or single-service or single-use articles.
13
maintenance may result in the creation of obnoxious odors or nuisances, and may
14
also adversely affect the operation of warewashing equipment or other equipment
15
which depends on sufficient volume and pressure to perform its intended functions.
16
Materials
17
Materials used in the construction of a mobile water tank are affected by the
18
water they contact. Tank liners may deteriorate and flake. Metals or platings
19
can be toxic. To prevent the degradation of the quality of the water, it is important
20
that the materials used in the construction of the tank are suitable for such
21
use.
5-301.11
as cross connections, backflow,
or
Improper repair or
Approved.
Guam Food Code Annex 1 – Public Health Reasons
248
1
Design and
5-302.11
Enclosed System, Sloped to Drain.
2
Construction
5-302.12
Inspection and Cleaning Port, Protected and
3
Secured.
4
The tank must be a closed system from the filling inlet to the outlet to prevent
5
contamination of water. It is important that the bottom of the tank be sloped
6
to the outlet to allow the tank to drain completely, to facilitate the proper
7
cleaning and disinfection of the tank, and to prevent the retention of water or
8
solutions after cleaning.
9
Some tanks are designed with an access opening to facilitate the cleaning and
10
servicing of the water tank. The access must be constructed to prevent the opening
11
from becoming a source of contamination of the water.
12
5-302.13
“V” Type Threads, Use Limitation.
13
V-type threads are difficult to clean if contaminated with food or waste. To
14
prevent the contamination of the drinking water, this type of thread should
15
only be used on water tank inlets and outlets if the connection is permanent
16
which eliminates exposed, difficult-to-clean threads.
17
5-302.14
18
Water tanks are equipped with a vent to preclude distortion during filling or
19
draining. The vent should be equipped with a suitable screen or filter to
20
protect the tank against the entry of insects or other vermin that may contaminate
21
the water supply.
22
Tank Vent, Protected.
5-302.15
Inlet and Outlet, Sloped to Drain.
Guam Food Code Annex 1 – Public Health Reasons
249
1
Both the inlet and outlet must be sloped to drain to prevent the pooling of
2
possibly contaminated water or sanitizing solution.
3
5-302.16
Hose, Construction and Identification.
4
Hoses used to fill potable water tanks should be dedicated for that one task
5
and should be identified
6
water. Hoses must be made of a material that will not leach detrimental
7
substances into the water.
8
Numbers and
9
Capacities
for that use only to prevent contaminating the
5-303.11
Filter, Compressed Air.
10
Compressor pistons are lubricated with oil to minimize wear. Some of the oil is
11
carried into the air lines and if not intercepted may contaminate the tank and
12
water lines.
13
5-303.12
Protective Cover or Device.
14
Protective equipment provided for openings of the water supply must be in
15
use to prevent contamination which may be present where the supply is
16
exposed to the environment, i.e., at water inlets or outlets or the ends of
17
transfer hoses.
18
5-303.13
Mobile Food Establishment Tank Inlet.
19
Mobile units may be particularly vulnerable to environmental contamination if
20
soiled hose connections are coupled to the tank inlet.
21
Operation and
22
Maintenance
5-304.11
System Flushing and Disinfection.*
Guam Food Code Annex 1 – Public Health Reasons
250
1
Contaminants of various types may be introduced into a water system during
2
construction or repair or other incidents. The system must be flushed and sanitized
3
after maintenance and before it is placed into service to prevent contamination of
4
the water introduced into the tank.
5
5-304.12
Using a Pump and Hoses, Backflow Prevention.
6
When a water system includes a pump, or a pump is used in filling a water
7
tank, care must be taken during hookup to prevent negative pressure on the
8
supplying water system.
9
especially necessary during cleaning and sanitizing operations on a mobile system.
10
5-304.13
Backflow prevention to protect the water supply is
Protecting Inlet, Outlet, and Hose Fitting.
11
When not connected for use, water inlets, outlets, and hose fittings should be
12
closed to the environment. Unless capped or otherwise protected, filling inlets,
13
outlets, and hoses may become contaminated by dust or vermin.
14
5-304.14
Tank, Pump, and Hoses, Dedication.
15
Hoses, pumps, and tanks used for food or water may not be used for other
16
liquids because this may contaminate the water supply. If a hose, tank, or pump
17
has been used to transfer liquid food, the equipment must be cleaned and
18
sanitized before using it for water delivery. Failure to properly clean and sanitize
19
the equipment would introduce nutrients, and possibly bacteria, into the water
20
as well as inactivate residual chlorine from public water supplies.
21
Mobile
5-401.11
Capacity and Drainage.
Guam Food Code Annex 1 – Public Health Reasons
251
1
Holding Tank
2
Liquid waste from a mobile or temporary food establishment must be stored
3
in a properly constructed waste tank to discourage the attraction of flies and
4
other vermin. The waste tank must be 15% larger than the water storage
5
tank to allow for storage of wastes and used water from the drinking water
6
supply tank. The drain from the waste tank must be larger than the filling
7
hose to prevent the use of the drinking water filling hose to drain the waste
8
tank.
9
Retention,
5-402.10
Establishment Drainage System.
10
Drainage, and
11
Delivery
12
The drainage system must be designed and installed properly to prevent the
13
backup of sewage and the possible contamination of foods or food-contact surfaces
14
in the establishment.
15
5-402.11
Backflow Prevention.*
16
Improper plumbing installation or maintenance may result in potential health hazards
17
such as cross connections, back siphonage or backflow. These conditions may
18
result in the contamination of food, utensils, equipment, or other food-contact
19
surfaces. It may also adversely affect the operation of equipment such as
20
warewashing machines.
21
The exception in paragraph 5-402.11(B) allows for a direct connection to the sanitary
22
sewer system for floor drains originating in refrigerated spaces that are
23
constructed
as
an
integral
part
of
the building structure.
Guam Food Code Annex 1 – Public Health Reasons
252
Examples of
1
refrigerated spaces that are considered an integral part of the building include
2
refrigerated prep rooms, meat cutting rooms, and refrigerated storage rooms.
3
The exception specifically targets refrigerated spaces that are considered an integral
4
part of the building. It does not apply to prefabricated walk-in refrigerators and
5
freezers with prefabricated floors. It is not intended to apply to pieces of
6
equipment, including those which may be located in a refrigerated room and
7
which indirectly drain to a floor drain within the room. Drainage from equipment is
8
addressed under paragraph 5-402.11(A).
9
5-402.12
Grease Trap.
10
Failure to locate a grease trap so that it can be properly maintained and
11
cleaned could result in the harborage of vermin and/or the failure of the sewage
12
system.
13
5-402.13
Conveying Sewage.*
14
5-402.14
Removing Mobile Food Establishment Waste.
15
Improper disposal of waste provides a potential for contamination of food, utensils,
16
and equipment and, therefore, may cause serious illness or disease outbreaks.
17
Proper removal is required to prevent contamination of ground surfaces and water
18
supplies, or creation of other insanitary conditions that may attract insects and other
19
vermin.
20
5-402.15
Flushing a Waste Retention Tank.
21
Thoroughly flushing the liquid waste retention tank will prevent the buildup of
22
deposits within the tank which could affect the proper operation of the tank.
23
Disposal
5-403.11
Approved Sewage Disposal System.*
Guam Food Code Annex 1 – Public Health Reasons
253
1
Facility
2
Many diseases can be transmitted from one person to another through fecal
3
contamination of food and water. This transmission can be indirect. Proper disposal
4
of human wastes greatly reduces the risk of fecal contamination. This Code
5
provision is intended to ensure that wastes will not contaminate ground surfaces or
6
water supplies; pollute surface waters; be accessible to children or pets; or allow
7
rodents or insects to serve as vectors of disease from this source.
8
9
5-403.12
Liquid food
Other Liquid Waste and Rainwater.
wastes and
rainwater
can
provide a
source of bacterial
10
contamination and support populations of pests. Proper storage and disposal
11
of wastes and drainage of rainwater eliminate these conditions.
12
Facilities
5-501.10
Indoor Storage Area.
13
on
5-501.11
Outdoor Storage Surface.
14
the Premises
5-501.12
Outdoor Enclosure.
15
5-501.13
Receptacles.
16
5-501.14
Receptacles in Vending Machines.
17
5-501.15
Outside Receptacles.
18
5-501.16
Storage Areas, Rooms, and Receptacles,
19
Capacity and Availability.
20
5-501.17
Toilet Room Receptacle, Covered.
21
5-501.18
Cleaning Implements and Supplies.
Guam Food Code Annex 1 – Public Health Reasons
254
1
5-501.19
Storage
Areas,
Redeeming
Machines,
2
Receptacles and Waste Handling Units,
3
Location.
4
5-501.110
5
6
Storage
Refuse,
Recyclables,
and
Returnables.
5-501.111
7
Areas, Enclosures, and Receptacles, Good
Repair.
8
5-501.112
Outside Storage Prohibitions.
9
5-501.113
Covering Receptacles.
10
5-501.114
Using Drain Plugs.
11
5-501.115
Maintaining Refuse Areas and Enclosures.
12
5-501.116
Cleaning Receptacles.
13
Proper storage and disposal of garbage and refuse are necessary to minimize
14
the development of odors, prevent such waste from becoming an attractant and
15
harborage or breeding place for insects and rodents, and prevent the soiling of
16
food preparation and food service areas. Improperly handled garbage creates
17
nuisance conditions, makes housekeeping difficult, and may be a possible
18
source of contamination of food, equipment, and utensils.
19
Storage areas for garbage and refuse containers must be constructed so that
20
they can be thoroughly cleaned in order to avoid creating an attractant or
21
harborage for insects or rodents. In addition, such storage areas must be
22
large enough to accommodate all the containers necessitated by the operation in
23
order to prevent scattering of the garbage and refuse.
Guam Food Code Annex 1 – Public Health Reasons
255
1
All containers must be maintained in good repair and cleaned as necessary in
2
order to store garbage and refuse under sanitary conditions as well as to
3
prevent the breeding of flies.
4
Garbage containers should be available wherever garbage is generated to aid
5
in the proper disposal of refuse.
6
Outside receptacles must be constructed with tight-fitting lids or covers to prevent
7
the scattering of the garbage or refuse by birds, the breeding of flies, or the
8
entry of rodents. Proper equipment and supplies must be made available to
9
accomplish thorough and proper cleaning of garbage storage areas and
10
receptacles so that unsanitary conditions can be eliminated.
11
Removal
12
5-502.11
Frequency.
5-502.12
Receptacles or Vehicles.
13
Refuse, recyclables, and returnable items, such as beverage cans and
14
bottles, usually contain a residue of the original contents. Spillage from these
15
containers soils receptacles and storage areas and becomes an attractant for
16
insects, rodents, and other pests. The handling of these materials entails some
17
of the same problems and solutions as the handling of garbage and refuse.
18
Problems are minimized when all of these materials are removed from the
19
premises at a reasonable frequency.
20
Facilities
21
for Disposal
22
and Recycling
5-503.11
Community or Individual Facility.
Guam Food Code Annex 1 – Public Health Reasons
256
1
Alternative means of solid waste disposal must be conducted properly to prevent
2
environmental consequences and the attraction of insects, rodents, and other
3
pests.
4
5
Chapter 6 Physical Facilities
6
Indoor Areas
7
Floors, walls, and ceilings that are constructed of smooth and durable surface
8
materials are more easily cleaned.
9
Floor surfaces that are graded to drain and consist of effectively treated materials
6-101.11
Surface Characteristics.
10
will prevent contamination of
11
moisture.
12
The special requirements for carpeting materials and nonabsorbent materials in
13
areas subject to moisture are intended to ensure that the cleanability of these
14
surfaces is retained.
15
Although food served from temporary food establishments is subject to the same
16
potential for contamination as food served in permanent establishments, the
17
limited capabilities and short duration of operation are recognized by less stringent
18
requirements for surface characteristics.
19
Outdoor Areas
20
The requirements concerning surface
21
intended to facilitate maintenance and minimize the accumulation of dust and
22
mud on walking and driving areas, provide durable exterior building surfaces,
6-102.11
foods from dust and organisms
from
pooled
Surface Characteristics.
characteristics
Guam Food Code Annex 1 – Public Health Reasons
257
of outdoor areas are
1
and prevent the attracting, harboring, or breeding of insects, rodents, and
2
other pests where refuse, recyclables, or returnables are stored.
3
Cleanability
4
6-201.11
Floors, Walls, and Ceilings.
6-201.12
Floors, Walls, and Ceilings, Utility Lines.
5
Floors that are of smooth, durable construction and that are nonabsorbent are more
6
easily cleaned. Requirements and restrictions regarding floor coverings, utility
7
lines, and floor/wall junctures are intended to ensure that regular and effective
8
cleaning is possible and that insect and rodent harborage is minimized.
9
6-201.13
Floor and Wall Junctures, Coved, and Enclosed or Sealed.
10
When cleaning is accomplished by spraying or flushing, coving and sealing of the
11
floor/wall junctures is required to provide a surface that is conducive to water
12
flushing.
13
Grading of the floor to drain allows liquid wastes to be quickly carried away, thereby
14
preventing pooling which could attract pests such as insects and rodents or
15
contribute to problems with certain pathogens such as Listeria monocytogenes.
16
6-201.14
Floor Carpeting, Restrictions and Installation.
17
Requirements and restrictions regarding floor carpeting are intended to ensure
18
that regular and effective cleaning is possible and that insect harborage is
19
minimized.
20
designed to ensure cleanability of surfaces where accumulation of moisture or waste
21
is likely.
22
The restrictions for areas not
6-201.15
suited for carpeting materials are
Floor Covering, Mats and Duckboards.
Guam Food Code Annex 1 – Public Health Reasons
258
1
Requirements regarding mats and duckboards are intended to ensure that regular
2
and effective cleaning is possible and that accumulation of dirt and
3
waste is prevented.
4
6-201.16
Wall and Ceiling Coverings and Coatings.
5
6-201.17
Walls and Ceilings, Attachments.
6
6-201.18
Walls and Ceilings, Studs, Joists, and Rafters.
7
Walls and ceilings that are of smooth construction, nonabsorbent, and in good
8
repair can be easily and effectively cleaned. Special requirements related to the
9
attachment of accessories and exposure of wall and ceiling studs, joists, and
10
rafters are intended to ensure the cleanability of these surfaces.
11
Functionality
12
Shielding of light bulbs helps prevent breakage. Light bulbs that are shielded,
13
coated, or otherwise shatter-resistant are necessary to protect exposed food,
14
clean equipment, utensils and linens, and unwrapped single-service and single-
15
use articles from glass fragments should the bulb break.
16
6-202.12
17
Heating and air conditioning system vents that are not properly designed and
18
located may be difficult to clean and result in the contamination of food, food
19
preparation surfaces, equipment, or utensils by dust or other accumulated soil
20
from the exhaust vents.
21
6-202.11
Light Bulbs, Protective Shielding.
Heating, Ventilating, Air Conditioning System Vents.
6-202.13
Insect Control Devices, Design and Installation.
22
Insect electrocution devices are considered supplemental to good sanitation
23
practices in meeting the Code requirement for controlling the presence of flies
Guam Food Code Annex 1 – Public Health Reasons
259
1
2
and other insects in a food establishment.
3
Improper design of the device and dead insect collection tray could allow dead
4
insect parts and injured insects to escape, rendering the device itself a
5
source of contamination.
6
Exposed
7
contamination by insects or insect parts. Installation of the device over food
8
preparation areas or in close proximity to exposed food and/or food-contact
9
surfaces could allow dead insects and/or insect parts to be impelled by the
10
electric charge, fall, or be blown from the device onto food or food-contact
11
surfaces.
food
12
and
food-contact
6-202.14
surfaces
must
be
protected
from
Toilet Rooms, Enclosed.
13
Completely enclosed toilet facilities minimize the potential for the spread of disease
14
by the movement of flies and other insects between the toilet facility and food
15
preparation areas.
16
6-202.15
Outer Openings, Protected.
17
Insects and rodents are vectors of disease-causing microorganisms which may
18
be transmitted to humans by contamination of food and food-contact surfaces. The
19
presence of insects and rodents is minimized by protecting outer openings to
20
the food establishment.
21
In the National Fire Protection Association’s NFPA 101, Life Safety Code, 2003
22
Edition, doors to exit enclosures such as stairs, horizontal exits, or exit passageways
Guam Food Code Annex 1 – Public Health Reasons
260
1
are required to be self closing. The Life Safety Code does not require exterior
2
doors used as exits to be self closing, but they can be.
3
The intent of subparagraph 6-202.15(A)(3) is to protect food establishments from
4
the entry of insects and rodents by keeping doors closed when not in use.
5
Self-closing devices allow a door to return to its closed position after use. If an
6
exterior door is not routinely used for entry or exit because its use is restricted by
7
the fire protection authority for emergency use only, it is not a portal for the entry of
8
pests and does not need a self-closing device. Doors not requiring a self-closing
9
device include exterior emergency exit doors that open into a public way from a
10
11
fire and that meet the criteria in ¶ 6-202.15(C).
6-202.16
Exterior Walls and Roofs, Protective Barrier.
12
Walls and roofs provide a barrier to protect the interior and foods from the weather,
13
windblown dirt and debris, and flying insects.
14
6-202.17
Outdoor Food Vending Areas, Overhead Protection.
15
The potential for contamination from airborne dust and particulates or inclement
16
weather is present in outside areas. Overhead protection minimizes the potential
17
for contamination of food under such conditions.
18
6-202.18
Outdoor Servicing Areas, Overhead Protection.
19
Pooled water, which may result if overhead protection is not provided for
20
outdoor servicing areas, attracts wild animals and birds and creates a
21
condition suitable for the breeding of insects.
22
6-202.19
Outdoor Walking and Driving Surfaces, Graded to Drain.
Guam Food Code Annex 1 – Public Health Reasons
261
1
If foot traffic is allowed to occur from undrained areas, contamination will be
2
tracked into the establishment. Surfaces graded to drain minimize these conditions.
3
Pooled water on exterior walking and driving surfaces may also attract rodents
4
and breed insects.
5
6-202.110
Outdoor Refuse Areas, Curbed and Graded to Drain.
6
If refuse areas are not graded properly, waste water will pool and attract insects
7
and rodents.
8
6-202.111
9
Private Homes and Living or Sleeping Quarters, Use Prohibited.
6-202.112
Living or Sleeping Quarters, Separation.
10
Areas or facilities that are not compatible with sanitary food establishment
11
operations must be located or separated from other areas of the establishment
12
to preclude potential contamination of food and food-contact surfaces from
13
poisonous or toxic materials, dust or debris, the presence of improperly
14
designed facilities and equipment, and the traffic of unauthorized and/or
15
unnecessary persons or pets.
16
Further, Article IV of the Amendments to the U.S. Constitution ensures the right
17
of persons to be secure in their homes against unreasonable search and seizure.
18
This provision could hinder the regulatory authority's access to conduct routine
19
inspections of a food establishment operated in the living area of a private
20
home. A search warrant may be the only mechanism by which to gain entry; yet, it
21
may be difficult to obtain and might not authorize the necessary inspectional
22
activities.
23
Handwashing
6-301.10
Minimum Number.
Guam Food Code Annex 1 – Public Health Reasons
262
1
Sinks
2
Refer to the public health reason for § 5-203.11.
3
6-301.11
Handwashing Cleanser, Availability.
4
Hand cleanser must always be present to aid in reducing microorganisms and
5
particulate matter found on hands.
6
6-301.12
Hand Drying Provision.
7
Provisions must be provided for hand drying so that employees will not dry their
8
hands on their clothing or other unclean materials.
9
10
6-301.14
Handwashing Signage.
A sign or poster is required to remind food employees to wash their hands.
11
6-301.20
Disposable Towels, Waste Receptacle.
12
Waste receptacles at handwashing sinks are required for the collection of disposable
13
towels so that the paper waste will be contained, will not contact food directly or
14
indirectly, and will not become an attractant for insects or rodents.
15
Toilets and
16
Urinals
17
Refer to the public health reason for § 5-203.12.
18
6-302.10
6-302.11
Minimum Number.
Toilet Tissue, Availability.
19
To minimize hand contact with fecal waste, toilet tissue is necessary for hygienic
20
cleaning following use of toilet facilities. Toilet tissue must be supplied to meet
21
the demand.
22
Lighting
6-303.11
Intensity.
Guam Food Code Annex 1 – Public Health Reasons
263
1
Lighting levels are specified so that
sufficient
light is available to enable
2
employees to perform certain functions such as reading labels; discerning the
3
color of
4
food, utensils, and supplies; and safely conducting general food establishment
5
operations and clean-up. Properly distributed light makes the need for cleaning
6
apparent by making accumulations of soil conspicuous.
7
Ventilation 6-304.11
8
When mechanical ventilation is necessary, it must have adequate capacity to ensure
9
that soiling of walls, ceilings, and other equipment is minimized; obnoxious odors
10
or toxic fumes are effectively removed; and no hazards or nuisances involving
11
accumulation of fats, oils, and similar wastes are created.
12
Balancing of the exhaust and make-up air must be ensured so that the system can
13
operate efficiently.
14
Dressing Areas
15
and Lockers
16
Street clothing and personal belongings can contaminate food, food equipment, and
17
food-contact surfaces. Proper storage facilities are required for articles such as
18
purses, coats, shoes, and personal medications.
19
Service Sinks
20
A service sink or curbed facility is required so that the cleanliness of the food
21
establishment can be maintained, attractants for insects and rodents minimized,
22
and contamination of food and equipment by accumulated soil prevented.
23
Liquid wastes generated during cleaning must be disposed of in a sanitary
substances; identifying toxic materials; recognizing the condition of
Mechanical.
6-305.11
6-306.10
Designation.
Availability.
Guam Food Code Annex 1 – Public Health Reasons
264
1
manner to preclude contamination of food and food equipment.
2
sink is provided to prevent the improper disposal of wastes into other sinks
3
such as food preparation and handwashing sinks.
4
Handwashing
5
Sinks
6
Facilities must be located in or adjacent to toilet rooms and convenient to the
7
different work stations of the food employee for proper and routine handwashing
8
to prevent contamination of the food and food-contact surfaces.
9
Toilet Rooms
6-401.10
A service
Conveniently Located.
6-402.11
Convenience and Accessibility.
10
Toilet rooms must be conveniently accessible to food employees at all times to
11
encourage employee use of appropriate facilities for the disposing of human wastes
12
as needed followed by the washing of hands.
13
Employee
14
Accommodations
15
Because employees could introduce pathogens to food by hand-to-mouth-to-
16
food contact and because
17
contaminants, areas designated to accommodate employees' personal needs
18
must be carefully located. Food, food equipment and utensils, clean linens, and
19
single-service and single-use articles must not be in jeopardy of contamination
20
from these areas.
21
Distressed 6-404.11
22
Merchandise
6-403.11
Designated Areas.
street clothing
and personal
Segregation and Location.
Guam Food Code Annex 1 – Public Health Reasons
265
belongings carry
1
Products which are damaged, spoiled, or otherwise unfit for sale or use in a
2
food establishment may become mistaken for safe and wholesome products and/or
3
cause contamination of other foods, equipment, utensils, linens, or single-service
4
or single-use articles. To preclude this, separate and segregated areas must
5
be designated for storing unsalable goods.
6
Refuse,
7
Recyclables,
8
and Returnables
9
Waste materials and empty product
6-405.10
Receptacles, Waste Handling Units, and
Designated Storage Areas.
containers are unclean and can be an
10
attractant to insects and rodents. Food, equipment, utensils, linens, and single-
11
service and single-use articles must be protected from exposure to filth and unclean
12
conditions and other contaminants. This Code provision addresses these
13
concerns by requiring the facility to be segregated, to be located to allow
14
cleaning of adjacent areas, and to preclude creation of a nuisance.
15
Premises,
16
Structures,
17
Attachments,
18
and Fixtures,
19
- Methods
20
Poor repair and maintenance compromises the functionality of the physical facilities.
21
This requirement is intended to ensure that the physical facilities are properly
22
maintained in order to serve their intended purpose.
23
6-501.11
6-501.12
Repairing.
Cleaning, Frequency and Restrictions.
Guam Food Code Annex 1 – Public Health Reasons
266
1
Cleaning of the physical facilities is an
2
protection and sanitary preparation of food. A regular cleaning schedule should be
3
established and followed to maintain the facility in a clean and sanitary manner.
4
Primary cleaning should be done at times when foods are in protected storage and
5
when food is not being served or prepared.
6
6-501.13
important
measure in ensuring the
Cleaning Floors, Dustless Methods.
7
Dustless floor cleaning methods must be used so that food; equipment, utensils,
8
and linens; and single-service and single-use articles are not contaminated.
9
6-501.14
10
Cleaning Ventilation Systems, Nuisance and Discharge
Prohibition.
11
Both intake and exhaust ducts can be a source of contamination and must be
12
cleaned regularly. Filters that collect particulate matter must be cleaned or changed
13
frequently to prevent overloading of the filter. Outside areas under or adjacent to
14
exhaust duct outlets at the exterior of the building must be maintained in a clean
15
and sanitary manner to prevent pest attraction.
16
6-501.15
17
Maintenance tools used to repair the physical facilities must be cleaned in a
18
separate area to prevent contamination of food and food preparation and
19
warewashing areas.
20
Cleaning Maintenance Tools, Preventing Contamination.*
6-501.16
Drying Mops.
21
Mops can contaminate food and food preparation areas if not properly cleaned
22
and stored after use. Mops should be cleaned and dried in a sanitary manner
23
Guam Food Code Annex 1 – Public Health Reasons
267
1
2
away from food flow areas.
6-501.17
Absorbent Materials on Floors, Use Limitation.
3
Cleanliness of the food establishment is important to minimize attractants for insects
4
and rodents, aid in preventing the contamination of food and equipment
5
and prevent nuisance conditions. A clean and orderly food establishment is also
6
conducive to positive employee attitudes which can lead to increased attention to
7
personal hygiene and improved food preparation practices.
8
cleaning procedures is important in precluding avoidable contamination of food and
9
equipment and nuisance conditions.
Use of specified
10
Temporary floor coverings such as sawdust can contaminate food, attract insects
11
and rodents, and become a nuisance to the food operation.
12
6-501.18
Maintaining and Using Handwashing Sinks.
13
Handwashing facilities are critical to food protection and must be maintained
14
in operating order at all times so they will be used.
15
Refer also to the public health reason for § 5-205.11.
16
6-501.19
Closing Toilet Room Doors.
17
Toilet room doors must remain closed except during cleaning operations to prevent
18
insect and rodent entrance and the associated potential for the spread of
19
disease.
20
6-501.110
Using Dressing Rooms and Lockers.
21
Street clothing and personal belongings can contaminate food, food equipment,
22
and food preparation surfaces and consequently must be stored
23
in properly designated areas or rooms.
Guam Food Code Annex 1 – Public Health Reasons
268
1
6-501.111
Controlling Pests.*
2
Insects and other pests are capable of transmitting disease to man by contaminating
3
food and food-contact surfaces. Effective measures must be taken to control their
4
presence in food establishments.
5
6-501.112
6
Removing Dead or Trapped Birds, Insects, Rodents, and Other
Pests.
7
Dead rodents, birds, and insects must be removed promptly from the facilities to
8
ensure clean and sanitary facilities and to preclude exacerbating the situation
9
by allowing carcasses to attract other pests.
10
6-501.113
Storing Maintenance Tools.
11
Brooms, mops, vacuum cleaners, and other maintenance equipment can contribute
12
contamination to food and food-contact surfaces. These items must be stored
13
in a manner that precludes such contamination.
14
To prevent harborage and breeding conditions for rodents and insects, maintenance
15
equipment must be stored in an orderly fashion to permit cleaning of the area.
16
6-501.114
Maintaining Premises, Unnecessary Items and Litter.
17
The presence of unnecessary articles, including equipment which is no longer used,
18
makes regular and effective cleaning more difficult and less likely. It can also
19
provide harborage for insects and rodents.
20
Areas designated as equipment storage areas and closets must be maintained
21
in a neat, clean, and sanitary manner. They must be routinely cleaned to avoid
22
attractive or harborage conditions for rodents and insects.
23
6-501.115
Prohibiting Animals.*
Guam Food Code Annex 1 – Public Health Reasons
269
1
Animals carry disease-causing organisms and can transmit pathogens to humans
2
through direct and/or indirect contamination of food and food-contact surfaces.
3
The restrictions apply to live animals with limited access allowed only in specific
4
situations and under controlled conditions and to the storage of live and dead fish
5
bait. Employees with service animals are required under § 2-301.14 to wash
6
their hands after each contact with animals to remove bacteria and soil.
7
Animals shed hair continuously and may deposit liquid or fecal waste, creating
8
the need for vigilance and more frequent and rigorous cleaning efforts.
9
The definition for “service animal” is adapted from 28 CFR 36.104 adopted pursuant
10
to the Americans with Disabilities Act (ADA) of 1990 (42 U.S.C. 12101 et seq.).
11
A service animal performs some of the functions that persons with a disability
12
cannot perform for themselves, such as those provided by “seeing eye dogs”;
13
alerting persons with hearing impairments to sounds; pulling wheelchairs or
14
carrying and picking up things for persons with mobility impairments; and assisting
15
persons with mobility impairments with balance. A service animal is not considered
16
to be a pet.
17
Under Title III of the ADA, privately owned businesses that serve the public are
18
prohibited from discriminating against individuals with disabilities. The ADA requires
19
these businesses to allow people with disabilities to bring their service animals onto
20
business premises in whatever areas customers are generally allowed. Some, but
21
not all, service animals wear special collars or harnesses. Some, but not all, are
22
licensed or certified and have identification papers.
Guam Food Code Annex 1 – Public Health Reasons
270
1
Decisions regarding a food employee or applicant with a disability who needs to
2
use a service animal should be made on a case-by-case basis. An employer
3
must comply with health and safety requirements, but is obligated to consider
4
whether there is a reasonable accommodation that can be made. Guidance is
5
available from the U.S. Department of Justice, Civil Rights Division, Disability Rights
6
Section or the U.S. Equal Employment Opportunity Commission, the Federal
7
agency which has the lead in these matters, in documents such as, “Commonly
8
Asked Questions About Service Animals in Places of Business”; “The Americans
9
with Disabilities Act Questions and Answers”; “A Guide to Disability Rights Laws”;
10
and “Americans with Disabilities Act Title III Technical Assistance Manual, 1994
11
Supplement.” The ADA Information Line is 800-514-0301 (voice) or 800-514-
12
0383
13
http://www.usdoj.gov/crt/ada/adahom1.htm.
(TDD)
and
the
Internet
Home
Page
address
is
14
Chapter 7 Poisonous or Toxic Materials
15
16
Original
17
Containers
18
The accidental contamination of food or food-contact surfaces can cause serious
19
illness. Prominent and distinct labeling helps ensure that poisonous and toxic
20
materials including personal care items are properly used.
21
Working
22
Containers
7-101.11
7-102.11
Identifying Information, Prominence.*
Common Name.*
Guam Food Code Annex 1 – Public Health Reasons
271
1
It is common practice in food establishments to purchase many poisonous or toxic
2
materials including cleaners and sanitizers in bulk containers. Working containers
3
are frequently used to convey these materials to areas where they will be
4
used, resulting in working containers being stored in different locations in the
5
establishment. Identification of these containers with the common name of the
6
material helps prevent the dangerous misuse of the contents.
7
Storage
7-201.11
Separation.*
8
9
Separation of poisonous and toxic materials in accordance with the requirements
10
of this section ensures that food, equipment, utensils, linens, and single-service
11
and single-use articles are properly protected
12
example, the storage of these types of materials directly above or adjacent to
13
food could result in contamination of the food from spillage.
14
Presence
15
and Use
16
The presence in the establishment of poisonous or toxic materials that are
17
not required for the maintenance and operation of the establishment represents
18
an unnecessary risk to both employees and consumers.
19
Preserving food safety depends in part on the appropriate and proper storage
20
and use of poisonous or toxic materials that are necessary to the maintenance
21
and operation of a food establishment. Even those that are necessary can pose
22
a hazard if they are used in a manner that contradicts the intended use of
23
the material as described by the manufacturer on the material's label. If additional
7-202.11
from contamination.
For
Restriction.*
Guam Food Code Annex 1 – Public Health Reasons
272
1
poisonous or toxic materials are present, there is an unwarranted increased
2
potential for contamination due to improper storage (e.g., overhead spillage that
3
could result in the contamination of food, food-contact surfaces, or food equipment)
4
or inappropriate application.
5
7-202.12
Conditions of Use.*
6
Failure to properly use poisonous or toxic materials can be dangerous. Many
7
poisonous or toxic materials have general use directions on their label. Failure to
8
follow the stated instructions could result in injury to employees and consumers
9
through direct contact or the contamination of food.
10
Particular precautions must be taken during the application of poisonous or toxic
11
materials to prevent the contamination of food and other food-contact surfaces.
12
Residues of certain materials are not discernible to the naked eye and present an
13
additional risk to the employee and consumer.
14
Because of the toxicity of restricted use pesticides, they can only be applied by
15
certified operators. A certified operator would be aware of the dangers involved in
16
the contamination of food and food-contact surfaces during the application of these
17
materials. Improperly applied pesticides present health risks to employees as well
18
as consumers and special precautions must be taken when restricted use
19
pesticides are applied.
20
Container
21
Prohibitions
22
Use of poisonous or toxic material containers to store, transport, or dispense
23
food is prohibited because of the potential for contamination of the food. The risk
7-203.11
Poisonous or Toxic Material Containers.*
Guam Food Code Annex 1 – Public Health Reasons
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1
of serious medical consequences to anyone consuming food stored in these
2
containers coupled with the lack of confidence that all of the material could or would
3
be removed in the wash and sanitizing procedures are reasons for prohibiting this
4
practice.
5
Chemicals
6
See explanation in § 4-501.114.
7
Chemical sanitizers are included with poisonous or toxic materials because
8
they may be toxic if not used in accordance with requirements listed in the Code
9
of Federal Regulations (CFR). Large concentrations of sanitizer in excess of
10
the CFR requirements can be harmful because residues of the materials remain.
11
The CFR reference that is provided lists concentrations of sanitizers that are
12
considered safe.
13
7-204.11
7-204.12
14
Sanitizers, Criteria.*
Chemicals for Washing Fruits and Vegetables,
Criteria.*
15
7-204.13
Boiler Water Additives, Criteria.*
16
7-204.14
Drying Agents, Criteria.*
17
If the chemical wash, boiler water additive, or drying agent used is not made
18
up of components that are approved as food additives or generally recognized
19
as safe, illness may result. This could be due to residues that may remain
20
from the use of compounds such as unrecognized drying agents. This is why
21
only those chemicals that are listed in the CFR can be used.
22
Chemicals that are not listed for these uses may be submitted for review by filing
23
a Food Additive Petition.
Wash chemicals, boiler water additives, and drying
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1
agents are classified as food additives because of the possibility that they may
2
end up in food. Therefore, they are subject to review before being used or listed
3
in the CFR.
4
21 CFR Section 173.315 specifically identifies chemicals that may be used in
5
washing fruits and vegetables, but it
6
(2000 ppm or otherwise) of chemical usage for sodium hypochlorite.
7
acknowledges the use of sodium hypochlorite on fruits and vegetables and also
8
allows calcium hypochlorite to be used interchangeably with sodium hypochlorite
9
under 21 CFR 173.315.
does not specify any maximum level
FDA
10
Boiler water additives that may be safely used in the preparation of steam that
11
may contact food, and their condition of use, are identified in 21 CFR 173.310
12
Boiler Water Additives.
13
Lubricants 7-205.11
14
Lubricants used on food equipment may directly or indirectly end up in the food.
15
Therefore, the lubricants used must be approved as food additives or generally
16
recognized as safe and listed in the CFR. Lubricants that are not safe present the
17
possibility of foodborne illness if they find their way into the food.
18
Pesticides
19
Incidental Food Contact, Criteria.*
7-206.11
Restricted Use Pesticides, Criteria.*
7-206.12
Rodent Bait Stations.*
20
Open bait stations may result in the spillage of the poison being used. Also,
21
it is easier for pests to transport the potentially toxic bait
22
establishment. Consequently, the bait may end up on food-contact surfaces and
23
ultimately in the food being prepared or served.
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throughout
the
1
7-206.13
Tracking Powders, Pest Control and Monitoring.*
2
The use of tracking powder pesticides presents the potential for the powder to
3
be dispersed throughout the establishment.
4
directly or indirectly contaminate food being prepared. This contamination could
5
adversely affect both the safety and quality of the food and, therefore, tracking
6
powder pesticides are not allowed.
7
Medicines
8
Medicines that are not necessary for the health of employees present an unjustified
9
risk to the health of other
7-207.11
Consequently, the powder could
Restriction and Storage.*
employees and consumers due to misuse and/or
10
improper storage.
11
There are circumstances that require employees or children in a day care center
12
to have personal medications on hand in the establishment.
13
misuse, personal medications must be labeled and stored in accordance with
14
the requirements stated for poisonous or toxic materials. Proper labeling and
15
storage of medicines to ensure that they are not accidentally misused or
16
otherwise contaminate food or food-contact surfaces.
17
7-207.12
To prevent
Refrigerated Medicines, Storage.*
18
Some employee medications may require refrigerated storage. If employee
19
medications are stored in a food refrigerator, precautions must be taken
20
to prevent the contamination of other items stored in the same refrigerator.
21
First Aid
22
Supplies
7-208.11
Storage.*
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1
First aid supplies for employee use must be identified and stored in accordance with
2
the requirements of this Code in order to preclude the accidental contamination of
3
food, food equipment, and other food-contact surfaces.
4
Other Personal
5
Care Items
6
Employee personal care items may serve as a source of contamination and
7
May contaminate food, food equipment, and food-contact surfaces if they are
8
not properly labeled and stored.
9
Storage and
7-209.11
7-301.11
Storage.
Separation.*
10
Display
11
Poisonous or toxic materials held for sale on store shelves or stored in stock rooms
12
present a risk of contamination of food, equipment, utensils, linens, and single-
13
service and single-use articles if not stored properly.
14
Chapter 8 Compliance and Enforcement
15
16
Construction
8-201.12
Contents of the Plans and Specifications.
17
Inspection and
8-203.10
Preoperational Inspections.
18
Approval
19
In conjunction with the Conference for Food Protection Plan Review committee,
20
FDA has participated in developing a document that is intended to assist regulators
21
in reviewing food establishment plans, and industry in understanding what is
22
expected in the plan review process. For several years, this FDA/CFP Food
23
Establishment Plan Review Guide – 2000 has been used in the FDA State
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1
Training Team
2
http://www.cfsan.fda.gov/~dms/prev-toc.html.
3
At the plan review stage, the
4
agent of the permit applicant who is seeking a building permit and who is
5
not in a position to discuss plans for safely conducting the food operation.
6
Nonetheless, the plan review step
7
foundation that enables the proposed operation to proactively sustain compliance
8
with the Code over time. Standard operating procedures (SOPs) are a part of
9
that foundation and ideally are developed in tandem with designing the facility.
10
Consequently, as an integral part of the plan review process, discussion needs to
11
occur about such procedures and their scope.
12
SOPs need to be developed by the time of the preoperational inspection and
13
put into effect when the food operation begins. It is recommended that such
14
procedures be written, available for reference by the person in charge, conveyed
15
to the appropriate employees, and available for review by the regulatory authority
16
during inspections. Operating procedures should include definitive practices and
17
expectations that ensure that:
18
(1)
Plan
The
Review courses.
transmission
It can be accessed through
regulatory authority may be dealing with an
presents
of
a unique opportunity to lay a
foodborne
disease is
prevented by
19
managing job applicants and food employees as specified under
20
Subpart 2-201,
21
22
(2)
Food is received from approved sources as specified under
§ 3-201.11,
Guam Food Code Annex 1 – Public Health Reasons
278
1
(3)
Food is managed so that the safety and integrity of the food from
2
the time of delivery to the establishment throughout its storage,
3
preparation, and transportation to the point of sale or service to the
4
consumer is protected,
5
(4)
Potentially hazardous (time/temperature control for safety) food is
6
maintained, including freezing, cold holding, cooking, hot holding,
7
cooling,
8
temperature and time requirements specified under Parts 3-4 and
9
3-5,
10
(5)
reheating,
and serving
in
conformance with the
Warewashing is effective, including assurance that the chemical
11
solutions and exposure times necessary for cleaning and sanitizing
12
utensils and food-contact surfaces of equipment are provided as
13
specified under Parts 4-6 and 4-7, and
14
15
(6)
Records that are specified
under §§ 3-203.11, 3-203.12, and
5-205.13 are retained for inspection.
16
During the plan review stage, the regulatory authority and a management
17
representative of the proposed food establishment should discuss available training
18
options that may be used to train food employees and the person in charge
19
regarding food safety as it relates to their assigned duties. By the time of the
20
preoperational inspection, operating procedures for training should include definitive
21
practices and expectations of how the management of the proposed food
22
establishment plans to comply with & 2-103.11(L) of this Code which requires the
Guam Food Code Annex 1 – Public Health Reasons
279
1
person in charge to assure that food employees are properly trained in food safety
2
as it relates to their assigned duties.
3
8-402.10
Competency of Inspectors.
4
Regulatory agencies are encouraged to use Standard #2 of the draft FDA’s
5
Recommended
6
(http://www.cfsan.fda.gov/~dms/ret-toc.html) to ensure employees who inspect
7
food establishments are properly trained.
8
encouraged to seek food safety certification through a nationally recognized and
9
accredited program.
National
Retail
Food
Regulatory
Standards
Regulatory inspectors are also
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280
Program