THE CULTURE OF CLEAN
MAY 4, 2017
TRACY GRAHAM
MANAGER, REGULATORY AFFAIRS
1
Food Safety Outbreak Visibility

Incidents increasingly visible

Improved detection & surveillance identifies broad issues
2012

2010
Supplier control essential
2006
2002
1999
1994
1997
• Ice Cream
• Ground
Beef
• Unpast. Juice
• Eggs, Chicken,
Beef, Pork
• Ground
Beef (2)
• RTE Turkey
& Chicken
2003
1998
1993
1996
2000
• QSR
Burgers
• Unpast. Juice
• Mad Cow
• Steak House
2009
2011
• Cookie Dough
•Milk Powder,
Peanut Butter,
Pistachios
• Sprouts
• Ground
Turkey,
Cantaloupe
• Cantaloupe
2007
• Green Onions
• Cereal
Salmonella
• Bagged
Spinach,
Restaurant
Lettuce
• Peppers, HVP,
Shell Eggs,
2008
Sprouts (2),
• Peppers,
Chicken
Tomatoes, Cereal Casserole, Raw
• Milk, Pork
Milk
• Lunch Meat
• Ground Beef (2)
• Pot Pies, Peanut
Butter
2005
• Chili Sauce
• Bagged Lettuce
Hepatitis A & Cyclospora
E. coli O157:H7
2
• Spinach, Mixed
Greens
• Ground Beef, Raw
Tuna, Mangoes,
Cantaloupe, Peanut
Butter
• Ricotta Cheese
Listeria
Botulism
Chemical
2013
• Chicken
• Cucumbers
• Berries
• Salad
2015 HDI Top Findings
% QSR Industry Non-Compliance
80
70
60
74.54
50
40
30
20
10
15.46
10.00
0
Food Contact Surface Clean to Sight
and Touch Total
Chemical Sanitization-Temp, pH,
Concentration, Hardness
3
Other Cleaning/Sanitation Violations
Definitions

Disinfection: a substance, or mixture of substances that destroys
or irreversibly inactivates bacteria, fungi and viruses, but not
necessarily bacterial spores, in the inanimate environment per EPA
OCSPP 810.2000

Detergent-Sanitizer: a sanitizer formulation that has been built
with specific ingredients that have the capability to clean and not to
interfere with the active ingredient so as to render our sanitizer
useless and not to be toxic if ingested in residual amounts by
humans

Soap/Detergent: a water soluble sodium or potassium salt of a
fatty acid
4
Define Your Surface

Food contact surfaces
 A surface of equipment or a utensil
with which food normally comes into
contact
 A surface of equipment or a utensil
from which may drain, drip or splash
into a food or onto a surface normally
in contact with food

Non-food contact surfaces
 Any other surfaces
5
Why Does Surface Type Really Matter?
6
Why Does Surface Type Really Matter?

Food Contact Surface
 Sanitizer
- Ingestion Tolerances
- No-rinse steps
 Disinfectants
- Potable rinse step

Non-Food Contact Surface
 Effective kill rate
 Rinse step not necessary

Important to have the right product for
the right surface type
7
Sanitizer Options
Thermal
Product
Radioactive
Typically must achieve a 99.999% reduction of representative
microorganisms *
8
Wash, Rinse, Sanitize

Washing step
 Removes soil and organic matter
 Sanitizers are designed to be applied to clean
surfaces

Rinsing step
 Removes the detergent and any excess debris
 If this step is not done properly, the excess
detergent is mixed with the sanitizer and can
neutralize the solution, thus making the
sanitizing step ineffective

Sanitizing step
 Reduces bacterial load by 99.999%
9
Washing
FDA FOOD CODE 2013
4-601.11 Equipment, Food Contact Surfaces, NonFood Contact Surfaces, and Utensils
Equipment, food contact surfaces and utensils shall be
clean to sight and touch
4-602.11 Equipment, Food Contact Surfaces and
Utensils
(C) Except as specified in (D), if used with potentially
hazard foods, equipment food contact surfaces and
utensils shall be cleaned through the day at least every
four hours
(D) Surface and utensils and equipment contacting
potentially hazard foods may be cleaned less frequently
than every four hours if…..
10
Rinsing
FDA FOOD CODE 2013
4-603.16 Utensils and Equipment
Washed utensils and equipment shall be rinsed so that
abrasives are removed or diluted through the use of
water or a detergent-sanitizer solution
11
Sanitizing
FDA FOOD CODE 2013
Sanitation: the application of cumulative heat or
chemical on cleaned food contact surfaces that,
when evaluated for efficacy, is sufficient to yield a
reduction of 5-log, which is equal to a 99.999%
reduction, of representative disease
microorganisms of public health importance
4-701.10 Food Contact Surfaces and Utensils
Equipment, food contact surfaces and utensils shall
be sanitized before use after cleaning
12
Detergent-Sanitizer
FDA FOOD CODE 2013

What is it really?

How can it be beneficial?
4-501.115 Detergent-Sanitizer
If a Detergent-Sanitizer is used to sanitize in a cleaning and sanitizing
procedure where there is no distinct water rinse step between the washing
and sanitizing steps, the agent applied in the sanitizing step shall be the
same Detergent-Sanitizer that is used in the washing step
13
The Consequences of Improper Cleaning

Food safety concerns

Inactivation of sanitizers

Biofilms can form, preventing effective sanitation
14
Wetting Penetration
Water Only:
Beads Form
Soil
Crack
Soil
Wetted Surface
Water Plus Surfactant:
15
Wetting Penetration
Surfactants
 Suspension
Water Only:

Beads Form
Alkalinity

Soil
Electrical charge
 Anionic
 Nonionic
 Cationic
 Amphoteric
Water Plus Surfactant:
16
Soil
Wetted Surface
Chemistry of Cleaning

Cleaners interact with soils on a physical basis
 Changes the solubility characteristics

Cleaners interact with soils on a chemical basis
 Reacts with the soil, forms a new, water soluble substance
17
Cleaning
FIVE FACTORS THAT IMPACT CLEANING
Time
Temperature

Must have precise temperature range

Must have sufficient contact time

Must have agitation to penetrate surface

Must have appropriate cleaning chemical

Must have proper cleaning procedures
Procedures
Agitation
Chemical
Action
18
Formulated / Built Detergents

Handle variety of soils
 Soils generally are not a pure composition

Handle various water conditions

Clean with less caustic
 Lower alkalinity
 Lower pH

Cleaning efficiency / optimized chemistry
19
Food Contact Surface Sanitizers

Categories





Chlorine
Iodophors
Peroxyacetic Acid
Quaternary Ammonium Compounds
Considerations






Efficacy under real conditions
Cost
Ease of application
Rinse step required?
Hazard classification
Compatibility with water source
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Food Contact Surface Sanitizers
1.
Must use EPA registered product
2.
Entire surface must be clean
3.
Time and temperature
4.
Use only for purposes listed on label
5.
Don’t mix products
6.
Use per manufacturer’s instructions
7.
Rinse, if required
8.
Test concentration
21
Food Contact Surface Sanitizers
LABEL OVERVIEW
22
Food Contact Surface Sanitizers
APPLICATION
Use per label instructions
Do not mix products
Rinse, if required
Test concentration
23
US Model Food Code

A reference document for state, city,
county and tribal agencies

Guidance for food safety practices based
on science

To mitigate risk factors that are known to
cause or contribute to food borne illness
outbreaks associated with retail and
foodservice establishments
24
US Model Food Code
ADOPTION BY STATE
25
US Model Food Code

Chapter 1: Purpose And Definitions

Chapter 2: Management And Personnel

Chapter 3: Food

Chapter 4: Equipment, Utensils, And Linens

Chapter 5: Water, Plumbing, And Waste

Chapter 6: Physical Facilities

Chapter 7: Poisonous Or Toxic Materials

Chapter 8: Compliance And Enforcement
26
US Model Food Code
CHAPTER 2 – MANAGEMENT AND PERSONNEL

2-301.12 Cleaning Procedure (hands and arms)
 How to wash hands

2-301.14 When to Wash
 Lists all scenarios as to when a food handler must wash
one’s hands

2-301.16 Hand Antiseptics
 Should an antimicrobial hand sanitizer be used without a
potable water rinse, specific criteria must be met
 If the specific criteria are not met, the product must be
followed with a potable water rinse before hand contact
with food or by the use of gloves

2-501.11 Clean-up of Vomiting and Diarrheal
Events
 Procedures are to be in place at a Food Establishment to
properly handle vomiting or diarrheal events
27
US Model Food Code
CHAPTER 3 – FOOD

3-302.15 Washing Fruits and Vegetables
 (A) Except as specified in (B) of this section and except for
whole, raw fruits and vegetables that are intended for
washing by the CONSUMER before consumption, raw fruits
and vegetables shall be thoroughly washed in water to
remove soil and other contaminants before being cut,
combined with other ingredients, cooked, served, or offered
for human consumption in ready to eat form
 (B) Fruits and vegetables may be washed by using
chemicals as specified under § 7-204.12
 (C) Devices used for on-site generation of chemicals
meeting the requirements specified in 21 CFR 173.315,
chemicals used in the washing or to assist in the peeling of
fruits and vegetables, for the washing of raw, whole fruits
and vegetables shall be used in accordance with the
manufacturer’s instructions
28
US Model Food Code
CHAPTER 4 – EQUIPMENT, UTENSILS, AND LINENS

4-302-14 Sanitizing Solutions, Testing Devices
 A test kit or other device that accurately measures the
concentration in MG/L of SANITIZING solutions shall be provided

4-501-19 Manual Warewashing Equipment, Wash
Solution Temperature
 The temperature of the wash solution in manual warewashing
equipment shall be maintained at not less than 43C (110F) or the
temperature specified on the cleaning agent manufacturer's label
instructions

4-501.115 Manual Warewashing Equipment, Chemical
Sanitization Using Detergent-Sanitizers
 If a detergent-SANITIZER is used to SANITIZE in a cleaning and
SANITIZING procedure where there is no distinct water rinse
between the washing and SANITIZING steps, the agent applied in
the SANITIZING step shall be the same detergent-SANITIZER
that is used in the washing step
29
US Model Food Code
ANNEX

Annex 1: Compliance And Enforcement

Annex 2: References

Annex 3: Public Health Reasons/Administrative Guidelines

Annex 4: Management Of Food Safety Practices – Achieving
Active Managerial Control Of Foodborne Illness Risk Factors

Annex 5: Conducting Risk-based Inspections

Annex 6: Food Processing Criteria

Annex 7: Model Forms, Guides, And Other Aids
30
WHAT DOES ALL OF THIS MEAN FOR YOU?
REGULATORY JURISDICTION OF FOOD
ANTIMICROBIALS CAN BE COMPLICATED.
31
FOOD QUALITY PROTECTION ACT (FQPA)

Prior to 1996: Enactment of the Food Quality Protection Act
 Required FDA food additive clearance and EPA Pesticide/Antimicrobial registration
 FDA regulated hard surface food contact sanitizing solutions at 21 CFR 178.1010
 EPA registered hard food contact sanitizing solutions under the Federal, Insecticide,
Fungicide & Rodenticide Act (FIFRA) as a pesticide

1996: President Clinton signs into law the Food Quality Protection Act
 Changes regulatory landscape/jurisdiction between EPA and FDA
 Narrowed definition of Food Additive (FDA) rendering 21 CFR 178.1010 null and void
 Expanded definition of Pesticide chemical (EPA) – moved jurisdiction for all pesticide
uses to EPA
 Changed the risk assessment standard for pesticide chemical residues (FQPA Safety
Standard)
 Result – EPA gained sole regulatory authority/jurisdiction over antimicrobials applied
to hard food contact surfaces
32
ANTIMICROBIAL TECHNICAL CORRECTION ACT
(ARTCA)

October 1998: President Clinton signed into law the Antimicrobial
Technical Correction Act
 To revert regulatory jurisdiction back to FDA
 While some jurisdiction was reverted back to FDA, EPA retained sole jurisdiction of
hard food contact surface sanitizers

July 1999: FDA issues Antimicrobials Food Additive Guidance
 Issued in consultation with EPA
 Clarifies in the wake of FQPA and ARTCA FDA’s jurisdiction over antimicrobials that
are use used in or on food, food uses of antimicrobials that are excluded from FDA’s
regulatory authority, and when an EPA FIFRA product registration is required
 Section 4 b. – Food contact substance antimicrobials
33
T he m icrobes to be controlled are in or on a . . .
Food-Contact
Substance
Processed
Food
Raw Ag.
Com m odity
W ash
W ater
or
Is the treatm ent in a food
processing facility, or during
transportation to such a facility?
Is the substance
EtO or PrO ?
Yes
No
EP A
FDA
Yes
No
FDA
EP A
Is the substance
used against m icrobes
in or on . . .
M ay also be
subject to FIFR A
Any Food Packaging
FDA
Surfaces of Food-Contact Articles & Equipm ent
EP A
Any Part of the Food-Contact Article other than the Surface,
O r, if it has no Antimicrobial Effect in or on the Finished Article
FDA
34
M ay also be
subject to FIFR A
M ay also be
subject to FIFR A
Pesticide Chemical residues regulated by EPA

Residues of antimicrobials applied to or in water containing Raw
Agricultural Commodities (RACs – whole fruit and vegetables) in the
field, during transportation to or in a facilities that is NOT a food
processing facility
 Antimicrobial Fruit and Vegetable treatments

Residues of hard surface food contact sanitizers used on permanent or
semi-permanent food contact surfaces (i.e. eating utensils, dishware,
countertops, tables, processing equipment)
35
Hard Surface Food Contact Sanitizer
Requirements

The product must be EPA registered as a hard surface food contact
sanitizer to be legally marketed
 EPA must conduct Section 408 of the Federal, Food, Drug and Cosmetic Act (FFDCA)
and make a safety finding which includes:
- Toxicity of the end use product and any break down products
- Aggregate exposure to the pesticide in foods and from other sources of exposure
- Special risks to infants and children
- Reasonable certainty that no harm will result from aggregate exposure to pesticide residues
 For commercial food use antimicrobial products EPA must:
- Issue food tolerances or maximum residue limits for residues on food or
- Issue exemptions from the requirement of a food tolerance (pesticide residues do not pose a dietary
risk under reasonably foreseeable circumstances)
- Tolerance or tolerance exemption is required for each formula ingredient (active and inert)
36
Hard Surface Food Contact Sanitizer
Requirements

EPA’s list of food tolerance exemptions are located at 40 CFR 180.940
“Tolerance exemptions for active and inert ingredients for use in
antimicrobial formulations (Food-contact surface sanitizing solutions)”

The food tolerance exemptions are divided into 3 subsections in
180.940 (a), (b), and (c)
 (a) Food contact surfaces in public eating places, dairy processing equipment and
food-processing equipment
 (b) Dairy processing equipment and food processing equipment and utensils
 (c) Food processing equipment and utensils
37
Hard Surface Food Contact Sanitizer
Requirements

EPA’s 40 CFR 180.940 replaces the former FDA 178.1010 “sanitizing
solutions” (no longer relevant)

Tolerances or exemptions from food tolerance are not required for
antimicrobials used on household food contact surfaces.
 EPA conducts a dietary risk assessment

EPA holds sole jurisdiction over hard surface food contact
sanitizers due to the passage of FQPA and ARTCA
38
WHAT MATTERS TO YOU
39