July 30, 2014
Divisions of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Via Electronic Filing: www.regulations.gov
Re: Docket No. FDA-2013-N-0013 – Sanitary Transportation of Human and Animal Food
To Whom It May Concern:
The American Trucking Associations, Inc. (ATA)1 and its affiliated conference, the Agricultural and Food
Transporters Conference (AFTC)2 are writing to comment on the Food and Drug Administration’s (FDA)
proposed rule (PR) entitled the Sanitary Transportation of Human and Animal Food (STF)3. As the
national representative of the trucking industry, ATA is interested in matters affecting the nation’s motor
carriers, including modifications to the regulations governing the transportation of food products. For this
reason, we appreciate this opportunity to comment on the PR.
The existing regulatory structure governing the transport of food in the United States has a proven track
record in preventing the outbreak of food borne illness. Prohibitions on the transportation of food in a
manner that causes adulteration combined with food industry standards specifically tailored to the types of
food, transportation methods, and subsequent food use have produced a food transportation system that is
the envy of the world. In the PR’s executive summary it states that “the goal of the PR is to ensure that
transportation practices do not create food safety risks”. From feedback that FDA has received, and given
the industry’s safety statistics, ATA believes “the goal” is already being reached. Also, given the fact that
the PR is based on the industry’s best practices, it shows that the transportation of food products is being
done properly, safely and efficiently. Understanding STF’s role in the FSMA, ATA would like to limit any
additional regulatory burden on an industry that continues to operate over and above standards currently
set.
Within the PR, a great deal of emphasis is placed on the carrier’s communication with the shipper, and
subsequently the receiver. This communication is common practice within the industry and has shown to
work well in providing successful shipments from point A to point B. It is in all parties best interests to
1
ATA is a united federation of motor carriers, state trucking associations, and national trucking conferences created to promote
and protect the interests of the trucking industry. Directly and through its affiliated organizations, ATA encompasses over 37,000
companies and every type and class of motor carrier operation.
2
The Agricultural and Food Transporters Conference is the national organization representing motor carrier and allied members of
the American Trucking Associations on critical issues affecting agricultural commodity and food transportation. Founded in 1995,
AFTC’s mission is to increase the safety, security, profitability and efficiency of transporters of agricultural commodities, food,
forest products and natural resources; and to serve as the advocate for its members within the American Trucking Associations and
before the government, other organizations and the public.
3
See 79 Federal Register 7005 (February 5, 2014)
Comments of the American Trucking Associations
Docket No. FDA-2013-N-0013
ensure proper conditions are kept for transporting all food products, and the specifics of those products
have been laid out in that communication. It is imperative, based on current industry practices, that
communication be allowed to transpire between those involved in the transaction in a way that works best
for the parties involved. The transportation industry, as is the case with many other industries, is very
diverse and the flexibility given to shippers and carriers must be allowed to continue. In many sections
within the PR this flexibility has been preserved, but there are concerns from industry on several sections
where additional burdens may be realized. The following comments are provided on content within the PR
by ATA, its members and affiliated organizations.
Cost/Benefit Analysis
ATA believes the numbers given within the PR on cost to the estimated 83,609 firms is grossly
underestimated. The first year cost of $149.1 million will be significantly higher if the firms are forced to
change their record keeping requirements from their current practice to the listed 12 month time frame
given in the recently updated guidance for recordkeeping.4 In addition to recordkeeping, the training
requirements could potentially increase that cost especially given the industry’s driver turnover rate.
Current training allows drivers the knowledge to properly transport food, but an increase or extension of
those requirements could substantially increase cost for companies. The time and effort those companies
need to expend in order to understand and comply with this rule will also contribute to the initial startup
cost.
ATA was also disappointed to see the benefit, or lack thereof, of this rule. In any successful business or
program it is imperative that a benefit will be gained if a cost will be incurred. Understanding that the
benefit will not always be monetary, increased regulatory burden on an industry that is already proven to
safely transport the nation’s food supply is unacceptable. In ATA’s 2010 comments to the 2005 STFA’s
ANPRM, the statistics show that there are 85 million shipments of food each year in the U.S., and over the
previous 36 years there were only four instances of transportation-caused food borne illness. These
statistics show an industry that has, and continues to do the right thing when it comes to transporting our
nation’s food. In addition to the statistics provided by ATA in 2010, this FDA PR makes mention to the
Interstate Food Transportation Project where they found ““little or no areas of concern” indentified with
larger (semi-tractor trailer) trucks inspected during the project’s survey.” These two points prove that the
transportation of the nation’s food supply is already meeting the “goal” of this PR, and the lack of benefits
for the rule supports that.
B. Definitions (Proposed § 1.904)
FDA’s proposed definition of “shipper” should be clarified (consistent with the agency’s stated and
appropriate intention) to place regulatory responsibility for transportation selection and management
directly on the singular person or entity that initiates a movement of food in commerce (i.e., the “true”
shipper who decides to ship a food product and sets the transportation process in motion). The regulatory
definition of “shipper” should clarify that it does not directly include logistics providers who merely
arrange for transportation services on behalf of their clients, and who are not necessarily or readily
knowledgeable about the nature of products being transported, or the conditions or options required to
protect individual products. The regulation should identify the client alone as the “shipper.” Service
providers to the shipper are then properly governed as a matter of contract with, and supervision by, the
client.
4
Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance
Guide.
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm391329.htm?source
=govdelivery&utm_medium=email&utm_source=govdelivery
Comments of the American Trucking Associations
Docket No. FDA-2013-N-0013
The proposed definition of “shipper” under 21 C.F.R. § 1.904, as written, could be read to misplace
liability on logistics providers who are providing a transportation coordination service, but who are not the
entities determining whether, and fundamentally how, to move food products in commerce. Instead, the
clients of the logistics provider are the “true” shippers who initiate the product movement, know the most
about their products, and are appropriately positioned to determine and enforce any requirements that must
be applied during transportation. FDA should clarify that the definition of “shipper” excludes logistics
providers or other third parties who merely arrange for transportation services on behalf of their clients,
and who may not independently have access to information about the products they are transporting for
their client or the conditions necessary to transport the products.
FDA defines “shipper” in the proposed rule as “a person who initiates a shipment of food by motor vehicle
or rail vehicle” (italics added). In the preamble to the proposed rule, FDA states that it defined the term
“shipper” in such a way as to assign the responsibility of shippers upon a single person, “the initiator of a
transportation operation, as [FDA] expect[s] this person to be knowledgeable about all factors concerning
the food, e.g., its packaging and holding temperature requirements, relevant to its sanitary transport.” 79
Fed. Reg. at 7014. FDA “tentatively concluded that [this definition] will ensure that food is not
transported under conditions that may render it adulterated and also that placing these responsibilities on a
single person will help to avoid any confusion regarding who is responsible for the requirements of a
‘shipper’ set forth in this proposed rule.” Id. In public meetings on this proposed rule, FDA also indicated
that the importance that the “shipper,” as defined in the proposed rule, is the one who understands the
product and can inform the carrier about the necessary transportation conditions to protect the product.5
The ATA agrees with FDA’s intention to assign “shipper” responsibility to (i) a single entity that (ii) is
most knowledgeable and appropriate and able to direct how products will be handled. In practice,
however, the proposed regulatory definition could be read broadly to encompass participants in the
transportation system other than the “true” initial shipper who knows the most about “all factors
concerning the food … relevant to its sanitary transport.” For example, the language could be read to
encompass logistics providers who arrange certain motor or rail vehicle services on behalf of their clients
based on the specifications provided by the shipper. As an example, a logistics provider may arrange for
transportation of a shipment on behalf of its client by way of air or ocean by booking space on an airline or
ocean vessel and also might arrange for inland transportation of the shipment on a motor vehicle to or from
the airport or ocean port. It is unclear under the proposed rule whether the logistics provider may be
considered to “initiate” the inland trucking transportation (the modality subject to the proposed rule) on
behalf of its client. In the grand scheme of things, however, the logistics provider does not “initiate” the
whole shipment – its client does, and the client must be responsible for overall compliance with the shipper
rules.
Thus, the proposed definition fails to fully capture FDA’s stated (and correct) intention, which was to
place responsibility on the party who knows the most about, and is best situated to control, the product
being shipped.
To the extent the proposed rule is overbroad, this proposal also is in contrast with current industry practice.
Standard industry practice is for the “true” shipper to specify requirements to a logistics provider; the
logistics provider makes arrangements with transportation providers that offer the necessary services to
transport a product (i.e., requested refrigeration, timing, etc.). Then, the shipper provides the necessary
specifications by contract that are flowed down to the transportation providers. Furthermore, logistics
providers often perform this service across a variety of industries, not just food. To impose a shipper’s
5
FSMA Proposed Rules on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration and Sanitary
Transportation of Human and Animal Food, FDA Transcript (Feb. 27, 2014), at 195-96.
Comments of the American Trucking Associations
Docket No. FDA-2013-N-0013
burdens directly on the logistics provider would be unduly burdensome and inappropriately hinder
commerce.
Importantly, logistics providers and transportation providers that fail to comply with the shipping
obligations are not immune from liability. It is standard practice for the originating shipper to contract
with its logistics provider and transportation provider(s), identifying expected levels of service and
potential penalties for failure, as part of their contractual agreement.
The transportation system is a complex and varied network of shippers, brokers, logistics providers, and
transportation providers, but it is a system that maintains accountability throughout all channels based on
proposed regulations, existing regulations, and contracting provisions. FDA’s proposed definition of
“shipper” blurs the distinction between shippers, transportation providers, and logistics providers in the
supply chain. The conventional notion of a shipper is the party that puts the product into commerce and
sets the transportation process in motion. The logistics provider seeks to understand the client’s needs and
to arrange for appropriate, available transportation providers. The originating shipper remains in the best
position to understand, communicate, and contractually enforce necessary conditions to transport food
products under safe conditions.
We respectfully request that FDA revise the definition of “shipper” to clarify that the originating entities
dispatching product into transportation are directly and solely responsible “shippers” for purposes of the
final rule.
FDA should exclude small-parcel common carriers from its definition of “carrier” under the proposed rule.
The proposed rule defines “carrier” as a “person who owns, leases, or is otherwise ultimately responsible
for the use of a motor vehicle or rail vehicle to transport food.” This definition, as it stands, could
encompass small-parcel common carriers, such as the United States Postal Service (USPS), United Parcel
Service, and Federal Express. The implications of this proposed rule on these small-parcel common
carriers are significant and costly. As such, we respectfully request that FDA clarify that these smallparcel common carriers are excluded from the definition of “carrier” under the proposed rule.
In a public meeting, Dr. Kashtock of FDA expressed skepticism that USPS and other similar small-parcel
common carriers were ever intended to be considered “carriers” under the proposed definition.6 In the
meeting, Dr. Kashtock states, “I don't know that I would go so far as to call the Postal Service a carrier.”
For reasons similar to those described in the preceding section, the responsibility is properly on the parcel
“shippers” to take necessary precautions to transport food. (“I think the first thing we would want to know
is what the shipper is doing to ensure that those risks aren’t real food safety problems. Is [the shipper]
providing insulated packs, for instance, because, again, he’s not dealing with an entity that can take on the
traditional responsibilities of the carrier?”). Dr. Kashtock acknowledged that FDA did not address the
concept of including small-parcel common carriers in the proposed rulemaking.7
As Dr. Kashtock highlighted in his response, the party tendering the shipment, i.e. the true shipper, is in
the best position to know the nature of the goods being shipped and is in the best position to take measures
to protect the product during transportation (again, for example, using a cold pack for temperaturesensitive shipments, or selecting overnight delivery to enable timely transportation as necessary to preserve
product integrity). Small-parcel common carriers handle millions of packages per day with a range of the
contents from clothing to shoes to food to electronics to books. To place any burden on a common carrier
to understand the unique shipping requirements for every product that it transports is unduly burdensome
and nearly impossible to accomplish. Furthermore, due to the nature of a small-parcel common carriers’
network, which relies on a web-like network for consolidating, sorting, and transporting parcels across an
6
7
FSMA Proposed Rule on Sanitary Transportation of Human and Animal Food, FDA Transcript (March 20, 2014), at 127-29.
Id. at 129.
Comments of the American Trucking Associations
Docket No. FDA-2013-N-0013
extremely wide range of geographic locations, it is impractical for a common carrier to segregate parcels
within transportation vehicles.
As such, if FDA intends to include small-parcel common carriers in the definition of “carrier” under the
proposed rule and to subject these companies to the same requirements as true carriers, then the practical
effect is that some common carriers, especially those large-scale common carriers, will simply exclude
food shipments from their network. This would reduce the availability of some of the most cost-effective
transportation channels for certain food shippers, even where there has been no demonstrated danger to
food safety in this channel. The more appropriate way to preserve food safety is to require the shipper of
any small parcel to ensure that the selected method and circumstances of transportation are appropriate for
the food product at issue.
In conclusion, the proposed rule’s definitions of “shipper” and “carrier” are overbroad and do not account
for some of the unique business relationships and services provided in the transportation industry. We
respectfully request that FDA revise the definition of “shipper” and to align with the conventional notion
of a shipper, which is the party that puts the product into commerce and sets the transportation process in
motion, and to exclude intermediaries that assist the true shippers with the acts of finding and coordinating
transportation providers that meet their specifications. Furthermore, FDA should revise the definition of
“carrier” to exclude those small-parcel common carriers that thousands of packages per day from a
multitude of industries and cannot reasonably be expected to understand the unique needs of each food
shipment and/or segregate certain food shipments from other types of shipments.
It is appropriate in all of these cases to require the person dispatching food products into commerce to
ensure that person takes appropriate food protection steps. The requested clarifications here leave
accountability intact where it is appropriate and will support the food safety goals of FDA, which we
support.
In addition, under FDA’s definition of “Transportation Operations” it notes that “…transportation
operations do not include any activities associated with the transportation solely of shelf stable food that is
completely enclosed…” We are concerned that the term “solely” could be interpreted as the shelf stable
food being exempt only if it is transported with other shelf stable food. We request the term solely be
stricken from throughout the rule to clear up any confusion.
E.
Transportation Operations (Proposed § 1.908)
Under Proposed § 1.908(a)(3) the rule “requires that all transportation operations be conducted under such
conditions and controls as are necessary to prevent the food that they are transporting from becoming
filthy, putrid, decomposed, or otherwise unfit for food, or being rendered injurious to health from any
source during transportation operations.” While ATA agrees with this statement, we would like to ensure
that practices are kept in place that allow flexibility for the industry. For example, if a shipping contract for
a time/temperature controlled for safety (TCS) food states a temperature threshold for a certain shipment
that the carrier be allowed flexibility within that threshold. A refrigerated trailer may be set at the correct
temperature, but the temperature will fluctuate due to the refrigeration unit turning on and off to reach the
set temperature. If the shipping contract states the product be kept at 35 degrees Fahrenheit, and the
product fluctuates between 32 and 38 degrees, the product should not be compromised. If the temperature
reached 45 degrees during transit, but only reached that temperature for two minutes prior to being cooled,
then the product should not be compromised. However, the quality assurance (or other) official at the
receiving end should be able to ensure whether that product is adulterated or not. ATA requests FDA
modify the rule to ensure that industry flexibility is allowed to continue.
In addition, ATA requests that food temperature controlled for quality not fall under the same guidelines as
food that is temperature controlled for safety. The goal, as stated by FDA, is to ensure food is transported
Comments of the American Trucking Associations
Docket No. FDA-2013-N-0013
in a way that keeps it from becoming adulterated, not less fresh. The industry, and consumers, will dictate
the freshness of a product. If industry best practices show that shippers and receivers require certain
products to be temperature controlled for quality then the carrier will follow those practices, but it is not
within FDA’s stated goal to regulate these products. It is also important to note that carriers often transport
TCS foods above the standards for safety to preserve the quality of the product. For example, frozen
dinners need to be transported at 28 degrees to ensure the safety of the product; however, shippers may ask
that the product be transported at 0 degrees to ensure the product’s quality stays intact.
Under Proposed § 1.908(a)(3)(iii), FDA states “Persons engaged in transportation operations that result in
the transportation of non-TCS food subject to microbial spoilage e.g. pasteurized juice, under conditions of
inadequate temperature control, would not meet the requirements of proposed § 1.908(a)(3)(iii), and we
may deem the food to be adulterated under section 402(i) of the FD&C Act in that the food has been
transported under conditions that are not in compliance with the sanitary food transportation regulations.”
ATA, carrier members, shippers and receivers have a great deal of concern with this statement. As
mentioned above, it is in the best interest of the entire supply chain, as well as consumers and insurers, to
keep current inspection standards in place. As stated in the rule, the shipper is in the best position to ensure
the products are kept at the correct temperatures, and that the equipment is properly cleaned. On the back
end, the receiver is in the best position to ensure the product is safe from adulteration. ATA wants to
ensure that receiver has flexibility to test the product if there was an issue during transport, and not be
forced to automatically decline the load because it was outside certain parameters for a short period of
time. ATA believes that if those within the supply chain were held to strict, rigid standards within a
contract that perfectly good loads would be deemed adulterated as a precaution to ensure regulations
within the STF are not violated. This action would lead to a substantial increase in cargo claims, and would
hurt, and possibly eliminate, the secondary food market (ex. correctional institutions, food banks,
secondary grocery stores, etc.). If these products are deemed adulterated then the manufacturer may not
allow those products to continue on to a secondary market for fear of again violating the STF regulations.
It is also important to note that these cargo claims are already governed by the “Carmack Amendment”
found in 49 U.S.C. 14706. In simple terms, it provides that carriers are liable for any “actual loss or injury
to the property” that are caused by the carrier. Thus, in order for a shipper or receiver to recover for cargo
loss or damage from a carrier, it must show that the cargo is actually lost or damaged. The mere
possibility of damage, though “potential” exposure is not sufficient to prove an actual loss. Title 21 U.S.C.
§ 342 (i) provides that food is considered adulterated when it is transported in noncompliance with sanitary
transportation practices, which practices are to be promulgated by regulation under section 350e of the
same title. The PR is the regulation authorized and contemplated by section 350e.
As the PR is written, food would be considered adulterated simply based on the failure of a carrier or other
party to conform to requirements of the PR, such as mandatory precooling and maintaining temperature
within specific shipper guidelines, regardless as to whether the food is actually damaged or unsafe. As a
result, the current cargo claims process would be dramatically impaired. Shippers and receivers would
understandably feel pressure to reject food products, regardless of its actual condition, if precooling did not
occur or the temperature left the requested guideline, even if only slightly and/or briefly. As was discussed
in several listening sessions with the FDA and various industry members, the temperature guidelines
provided by shippers to carriers frequently has to do with product quality, rather than actual food safety. A
slight or brief variation from temperature guidelines rarely would create a safety threat in the vast majority
of circumstances due to this distinction. The practical reality is that cargo claims would likely increase
dramatically, resulting in rejected loads due to harmless temperature fluctuations. A single cargo claim on
food products can exceed $100,000 per claim. However, the current cargo claim process under Carmack
requires a showing of liability and actual damage in order for a claim to be successful. Under the PR, a
showing liability and actual damage would be no longer be required for food to be considered adulterated.
Even if the PR only results in a single additional successful cargo claim for each firm, the cost of that
Comments of the American Trucking Associations
Docket No. FDA-2013-N-0013
claim will dramatically exceed those estimated by the FDA. As was also discussed in the listening
sessions with the FDA, the carriers, shippers, and receivers alike want to avoid increased or unnecessary
cargo litigation as it is extremely costly, time consuming, and wasteful.
Under proposed § 1.908(b)(4), FDA focuses on mandating the precooling of containers transporting “food
that can support the rapid growth of undesirable microorganisms in the absence of temperature control
during transportation…” Although precooling is often a good practice for TCS food transport, sometimes
it is not necessary or even possible to precool prior to loading. For example, carriers hauling frozen food,
e.g. ice cream, use that product to cool the trailer during transport. If Carrier A is transporting a load of ice
cream during the month of August it would not be possible to precool the trailer to the specified
temperature without getting that trailer “flash cooled” prior to loading. This practice takes time and is
costly to the carrier. The best practice is to load the product onto the refrigerated trailer and then use that
cold product to assist in reaching the proper temperature listed in the contract. Another example that
impacts both precooling and temperature requirements is the loading of warm product. If the shipper is
shipping a TCS product and brings it dockside prior to the carrier arriving, that product will begin to
increase in temperature. If that product has increased in temperature prior to loading then it will in turn
increase the trailer temperature until it has a chance to return to its proper temperature. This scenario is
completely out of the carrier’s hands and needs to be taken into account when looking at temperature of
the product and temperature of the trailer throughout transport. The precooling request should come from
the shipper, if required, and not be mandated by the regulations.
Under proposed § 1.908(d)(2) FDA requires the carrier, and if contractually obligated, the shipper, to
demonstrate to the receiver that temperature was maintained throughout the movement of the product. This
requirement would place a great burden on those in the industry with both large and small operations.
Many of the smaller operations may not have two way communications for downloading the information
and would then have to visit a third party which would be costly and time prohibitive. The larger
companies may have the technology, but would incur a great deal of cost to both the out of service vehicles
during the download process and the cost of downloading and sending the information. It is necessary to
have these documents available when requested, but there is no reason to mandate these temperature
reports be accessed after every transportation operation.
F.
Training (Proposed § 1.910)
As noted throughout the rule, FDA believes that the transportation industry is overall successful in safely
transporting human and animal food products. The ERG report and finding released in 2007 by the
Michigan Department of Agriculture both mention a lack of driver awareness of safe food temperatures.
ATA would disagree with these two reports, especially since the temperature requirements are to be set by
the shipper and conveyed to the carrier. The onus is on the shipper to convey these temperatures to the
carrier. Also, the two studies mentioned in the PR summary both state how safe the large truck
transportation of food products are, and the main concern targeting box trucks. ATA believes that the
industry has current training guidelines and procedures in place that properly address training in handling
and transporting of food. Each specific food type has its own specific procedures in safe handling, and it is
in the best interest of those involved to allow each specific industry to train each employee properly.
Training is an important component in keeping our food supply safe, and we should continue to let those
most educated on their particular product train within their own guidelines.
G.
Recordkeeping (Proposed § 1.912)
Recordkeeping requirement is 12 months for training, sanitizing, cleaning, and most other reporting
portions of the STF rule. ATA feels that this timeframe is unnecessary and burdensome for those in the
industry. It is important to show a process is in place for training, sanitizing and cleaning, but holding on
Comments of the American Trucking Associations
Docket No. FDA-2013-N-0013
to records for one year would not benefit those along the supply chain. Given the diversity of those hauling
food products, every carrier has different procedures for recordkeeping. However, they should only be
“required” to provide evidence of those procedures.
Exemptions
Within the stated exemptions, FDA plans to exempt those operations (shippers, carriers and receivers) that
make less than $500,000 in total annual sales. ATA believes that this exemption needs to be further
examined. In the preamble, references to those most likely to be found with adulterated food were the
smaller box trucks and those making daily deliveries. ATA wants to ensure that the final rule addresses
those who have the greatest risk of causing food borne related illness, and not exempt them from the rule
that would minimize that risk. The modifications being proposed to FDA from ATA and others in the
industry would help in significantly reducing the financial burden to businesses big and small and should
be considered when determining the details of this exemption.
It is also important to note that if a shipper is brokering loads to smaller carriers that are exempted from
this rule, the shipper may no longer utilize those carriers because they do not have to adhere to the same
guidelines and may be unfairly considered less safe than those that do. These two points show how the
exemption may be harmful to not only the safety of the food, but also to the smaller carriers.
Conclusion
The transportation of food in the U.S. has been statistically proven to be the safest in the world. The lack
of incidents of food borne illness from the transportation of food show how seriously the industry takes the
issue of food safety and how current policies and procedures are working. Those shipping the food
communicate to those carrying the food how it should be handled in transport, and those receiving the food
ensure the product arrives in satisfactory condition. The communication throughout this chain should be
the basis for how the final rule is written. Many, if not all, of the requirements should be included in the
shipping papers by the entity that knows most about the product, the shipper. The carrier then follows
those guidelines during transit and delivery at the receiver. The receiver then ensures that there were no
issues, and is able to check and verify the product if there were. ATA’s goal for the final rule is to ensure
this communication and flexibility that currently takes place within the industry is allowed to continue.
ATA would like to again thank the FDA for the opportunity to comment on the Sanitary Transportation of
Human and Animal Food. We appreciate the openness and willingness of FDA’s staff to meet with our
broad coalition and work with us on crafting a rule that everyone can be satisfied with. That being said,
there are a few sections within the rule that are of concern to the industry. ATA requests that the rule be
reopened or reproposed so as to give the public an opportunity to comment on any significant changes that
are made to the PR prior to it being finalized. This interaction and continued communication will ensure
FDA has everything they need to make an informed decision when finalizing the rule.
*Note – With the 60 day extension of the comment period, ATA worked with a third party marketing firm
–Hanover Research- to survey ATA members carrying refrigerated products. The survey focused on cost,
record keeping, temperature protocols, sanitization and training. The survey received 80 responses giving
the strong majority of the questions a statistically significant rating. The survey has been included as
Attachment #1.