[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Rules and Regulations]
[Pages 20091-20170]
[FR Doc No: 2016-07330]

Vol. 81

Wednesday,

No. 66

April 6, 2016

Part III

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 1 and 11

Sanitary Transportation of Human and Animal Food; Final Rule

Federal Register / Vol. 81 , No. 66 / Wednesday, April 6, 2016 /
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 11

[Docket No. FDA-2013-N-0013]
RIN 0910-AG98

Sanitary Transportation of Human and Animal Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is issuing a
final rule to establish requirements for shippers, loaders, carriers by
motor vehicle and rail vehicle, and receivers engaged in the
transportation of food, including food for animals, to use sanitary
transportation practices to ensure the safety of the food they
transport. This action is part of our larger effort to focus on
prevention of food safety problems throughout the food chain and is
part of our implementation of the Sanitary Food Transportation Act of
2005 (2005 SFTA) and the Food Safety Modernization Act of 2011 (FSMA).

DATES: This rule is effective June 6, 2016. See section V for the
compliance dates.

FOR FURTHER INFORMATION CONTACT: Michael Kashtock, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
Purpose and Coverage of the Rule
Summary of the Major Provisions of the Rule
Costs and Benefits
I. Background
    A. FDA Food Safety Modernization Act
    B. What risks to humans and animals have been associated with
the transportation of food? How has this issue been addressed in the
past?
    C. What did the Sanitary Food Transportation Act of 2005 and the
Food Safety Modernization Act of 2011 do with respect to food
transportation? What other activities did we conduct for this
rulemaking?
    D. What did we propose to do?
II. What is the legal authority for this rule?
III. What general comments did we receive on the proposed rule?
    A. Purpose of This Rule
    B. What regulatory approach should we take?
    C. How does this rule relate to other FSMA rules?
    D. Effect of Other Statutes on the Applicability of This Rule
and How This Rule Affects Food Regulated by Other Federal Agencies
    E. Other Comments
IV. What comments did we receive on the specific provisions of the
proposed rule?
    A. Who is subject to this subpart? (Sec.  1.900)
    B. How do the criteria and definitions in this subpart apply
under the Federal Food, Drug, and Cosmetic Act? (Sec.  1.902)
    C. What definitions apply to this subpart? (Sec.  1.904)
    D. What requirements apply to vehicles and transportation
equipment? (Sec.  1.906)
    E. What requirements apply to transportation operations? (Sec.
1.908)
    F. What training requirements apply to carriers engaged in
transportation operations? (Sec.  1.910)
    G. What record retention and other records requirements apply to
shippers, receivers, loaders, and carriers engaged in transportation
operations? (Sec.  1.912)
    H. Waivers (Sec. Sec.  1.914-1.934)
V. Effective and Compliance Dates
    A. Effective and Compliance Dates for Part 1, Subpart O
    B. Effective Dates for Conforming Changes
VI. Executive Order 13175
VII. Economic Analysis of Impacts
VIII. How does the Paperwork Reduction Act of 1995 apply to this
final rule?
IX. What is the environmental impact of this rule?
X. What are the federalism impacts of this rule?
XI. References

Executive Summary

Purpose and Coverage of the Rule

    This rule is part of FDA's implementation of the 2005 SFTA and the
FSMA. These statutes require us to issue regulations requiring
shippers, carriers by motor vehicle or rail vehicle, receivers, and
other persons engaged in the transportation of food to use sanitary
transportation practices to ensure that food is not transported under
conditions that may render the food adulterated. This rule creates new
requirements for the sanitary transportation of human and animal food
by motor vehicle and rail vehicle to ensure that transportation
practices do not create food safety risks. Practices that create such
risk include failure to properly refrigerate food requiring temperature
control for food safety, the inadequate cleaning of vehicles between
loads, and the failure to otherwise properly protect food during
transportation. This rule builds on current safe food transportation
best practices and is focused on ensuring that persons engaged in the
transportation of food that is at the greatest risk for contamination
during transportation follow appropriate sanitary transportation
practices. The rule is flexible to allow the transportation industry to
continue to use industry best practices concerning cleaning,
inspection, maintenance, loading and unloading of, and operation of
vehicles and transportation equipment to ensure that food is
transported under the conditions and controls necessary to prevent
adulteration linked to food safety.

Summary of the Major Provisions of the Rule

    As required by the 2005 SFTA, this final rule addresses the
sanitary transportation of food (human and animal food) by establishing
criteria and definitions that apply in determining whether food is
adulterated because it has been transported or offered for transport by
a shipper, loader, carrier by motor vehicle or rail vehicle, or
receiver engaged in the transportation of food under conditions that
are not in compliance with the sanitary food transportation
regulations. This rule defines transportation as ``any movement of food
in commerce by motor vehicle or rail vehicle'' and establishes
requirements for sanitary transportation practices applicable to
shippers, loaders, carriers by motor vehicle and rail vehicle, and
receivers engaged in food transportation operations addressing:
     Vehicles and transportation equipment;
     Transportation operations;
     Training;
     Records; and
     Waivers.
    This rule allows the transportation industry to continue to use
best practices, i.e., ``commercial or professional procedures that are
accepted or prescribed as being correct or most effective,'' (Ref. 1),
concerning cleaning, inspection, maintenance, loading and unloading,
and operation of vehicles and transportation equipment that it has
developed to ensure that food is transported under the conditions and
controls necessary to prevent adulteration linked to food safety.
    We made several revisions to this final rule, in response to
comments that we received regarding the proposed rule, to affirm that
the use of current sanitary food transportation best practices as
described in these comments, e.g., the ``Rendering Industry Code of
Practice'' and ``Model Tanker Wash Guidelines For the Fruit Juice
Industry,'' will allow industry to meet the requirements of this rule.
Some of these best practices have been provided to the Agency as
industry documents submitted with comments on the proposed rule, while
others were described in the comments or the public meetings we held
for the proposed rule.

    As discussed in detail in later sections of the rule, we made
several major revisions to the provisions of this rule mainly in
response to comments that focus the rule more narrowly on food safety
and are consistent with existing safe transportation best practices.
These major revisions include the following:
     We have simplified the definitions for parties covered by
the rule to make them all activity based and added a definition for
``loader'' as a new party covered by the rule, based on comments
indicating that this was a relevant segment of the transportation
industry that we had not previously identified.
     We have amended the definition of ``transportation
operations'' such that additional transportation activities are not
covered by the rule, including transport of food completely enclosed by
a container, except food that requires temperature control for safety
(broadens proposed exclusion for transport of shelf stable food
completely enclosed by a container), food contact substances, and human
food byproducts transported for use as animal food without further
processing.
     We changed the provisions of the rule to focus on food
safety concerns and not additionally adulteration as a result of
spoilage or quality defects. Therefore, we have replaced language
indicating that the goal of the rule is prevention of both food safety
and non-safety concerns with language indicating that the goal is
prevention of food becoming ``unsafe, i.e., adulterated within the
meaning of section 402(a)(1), (2), and (4) of the FD&C Act'' during
transportation operations.
     We have removed prescriptive requirements for temperature
monitoring devices and continuous monitoring of temperature during
transport and replaced these provisions with a more flexible approach
which allows the shipper and carrier to agree to a temperature
monitoring mechanism for shipments of food that require temperature
control for safety. We have also removed the provision requiring the
carrier to demonstrate temperature control to the receiver for every
shipment requiring temperature control. In this final rule, the
demonstration must only be made if the shipper or receiver requests it,
which is consistent with industry best practices and would likely only
be done in situations in which it is suspected that there has been a
material failure of temperature control.
     We have revised this rule to require that if a person
subject to this rule becomes aware of an indication of a possible
material failure of temperature control or other conditions that may
render the food unsafe during transportation, the person must take
appropriate action, to ensure that the food is not sold or otherwise
distributed unless a determination is made by a qualified individual,
that the temperature deviation or other condition did not render the
food unsafe.
     We have revised the requirements of this final rule to
make it clear that its requirements account for the fact that the
intended use of the vehicle or equipment with respect to the type of
food that is being transported, e.g., the transportation of animal feed
versus food for humans, is relevant in establishing the applicable
sanitary transportation requirements, as is the production stage of the
food being transported, e.g., raw materials, ingredients, or finished
food products.
     Finally, we have revised the rule to primarily place the
responsibility for determinations about appropriate transportation
operations (e.g., whether food needs temperature control for safety and
the relevant operating temperature and mode of temperature monitoring,
whether particular clean out procedures are needed, and whether
previous cargo must be identified) on the shipper. The shipper may rely
on contractual agreements to assign some of these responsibilities to
other parties, such as a loader or carrier, if they agree to accept the
responsibility. We believe the shipper is in the best position of the
parties covered by this rule to know the appropriate specifications for
transport of its food.

Costs and Benefits

    This final rule implements requirements addressing the sanitary
transportation of human and animal food. It establishes requirements
for sanitary transportation practices applicable to shippers, carriers
by motor vehicle and rail vehicle, loaders, and receivers.
Specifically, these finalized requirements address design and
maintenance of vehicles and transportation equipment; sanitary
practices during transportation operations that apply to shippers,
receivers, loaders, and carriers; training of carrier employees; and
records related to, for example, training, and written procedures. As
shown in table 1, the total annualized costs are estimated to be
approximately $113 million per year, estimated with a 3 percent
discount rate, and $117 million per year, estimated at 7 percent when
discounted over 10 years. We do not have sufficient data to fully
quantify the benefits of this regulation.

                                      Table 1--Estimated Costs and Benefits
                                               [In millions of $]
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                                              Initial costs      Annual                    Benefits
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                                                     $162.7           $93.5  Not quantified.
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                                         Costs Annualized over 10 Years
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                                                          Costs                            Benefits
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3%.........................................               $113               Not quantified.
7%.........................................                117
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I. Background

A. FDA Food Safety Modernization Act

    FSMA (Pub. L. 111-353), signed into law by President Obama on
January 4, 2011, is intended to allow FDA to better protect public
health by helping to ensure the safety and security of the food supply.
FSMA enables us to focus more on preventing food safety problems rather
than relying primarily on reacting to problems after they occur. The
law also provides new enforcement authorities to help achieve higher
rates of compliance with risk-based, prevention-oriented safety
standards and to better respond to and contain problems when they do
occur. In addition, the law contains important new tools to better
ensure the safety of imported foods and encourages

partnerships with State, local, tribal, and territorial authorities and
international collaborations with foreign regulatory counterparts. A
top priority for FDA are those FSMA-required regulations that provide
the framework for industry's implementation of preventive controls and
enhance our ability to oversee their implementation for both domestic
and imported food. To that end, we proposed the seven foundational
rules listed in table 2 and requested comments on all aspects of these
proposed rules.

    Table 2--Published Foundational Rules for Implementation of FSMA
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              Title                  Abbreviation         Publication
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Current Good Manufacturing        2013 proposed       78 FR 3646,
 Practice and Hazard Analysis      human preventive    January 16, 2013.
 and Risk-Based Preventive         controls
 Controls for Human Food.          regulation.
Standards for the Growing,        2013 proposed       78 FR 3504,
 Harvesting, Packing, and          produce safety      January 16, 2013.
 Holding of Produce for Human      regulation.
 Consumption.
Current Good Manufacturing        2013 proposed       78 FR 64736,
 Practice and Hazard Analysis      animal preventive   October 29, 2013.
 and Risk-Based Preventive         controls
 Controls for Food for Animals.    regulation.
Foreign Supplier Verification     2013 proposed FSVP  78 FR 45730, July
 Programs (FSVP) for Importers     regulation.         29, 2013.
 of Food for Humans and Animals.
Accreditation of Third-Party      2013 proposed       78 FR 45782, July
 Auditors/Certification Bodies     third-party         29, 2013.
 to Conduct Food Safety Audits     certification
 and to Issue Certifications.      regulation.
Focused Mitigation Strategies To  2013 proposed       78 FR 78014,
 Protect Food Against              intentional         December 24,
 Intentional Adulteration.         adulteration        2013.
                                   regulation.
Sanitary Transportation of Human  2014 proposed       79 FR 7006,
 and Animal Food.                  sanitary            February 5, 2014.
                                   transportation
                                   regulation.
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    We also issued a supplemental notice of proposed rulemaking for the
rules listed in table 3 and requested comments on specific issues
identified in each supplemental notice of proposed rulemaking.

 Table 3--Published Supplemental Notices of Proposed Rulemaking for the
              Foundational Rules for Implementation of FSMA
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              Title                  Abbreviation         Publication
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Current Good Manufacturing        2014 supplemental   79 FR 58524,
 Practice and Hazard Analysis      human preventive    September 29,
 and Risk-Based Preventive         controls notice.    2014.
 Controls for Human Food.
Standards for the Growing,        2014 supplemental   79 FR 58434,
 Harvesting, Packing, and          produce safety      September 29,
 Holding of Produce for Human      notice.             2014.
 Consumption.
Current Good Manufacturing        2014 supplemental   79 FR 58476,
 Practice and Hazard Analysis      animal preventive   September 29,
 and Risk-Based Preventive         controls notice.    2014.
 Controls for Food for Animals.
Foreign Supplier Verification     2014 supplemental   79 FR 58574,
 Programs (FSVP) for Importers     FSVP notice.        September 29,
 of Food for Humans and Animals.                       2014.
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    We finalized five of the foundational rulemakings listed in table 4
in September and November 2015.

    Table 4--Published Foundational Rules for Implementation of FSMA
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              Title                  Abbreviation         Publication
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Current Good Manufacturing        Final human         80 FR 55908,
 Practice, Hazard Analysis, and    preventive          September 17,
 Risk-Based Preventive Controls    controls            2015.
 for Human Food.                   regulation.
Current Good Manufacturing        Final animal        80 FR 56170,
 Practice, Hazard Analysis, and    preventive          September 17,
 Risk-Based Preventive Controls    controls            2015.
 for Food for Animals.             regulation.
Foreign Supplier Verification     Final FSVP          80 FR 74225,
 Programs for Importers of Food    regulation.         November 27,
 for Humans and Animals.                               2015.
Standards for the Growing,        Final produce       80 FR 74353,
 Harvesting, Packing, and          safety regulation.  November 27,
 Holding of Produce for Human                          2015.
 Consumption.
Accreditation of Third-Party      N/A...............  80 FR 74569,
 Certification Bodies To Conduct                       November 27,
 Food Safety Audits and To Issue                       2015.
 Certifications.
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    As FDA finalizes these seven foundational rulemakings, we are
putting in place a modern, risk-based framework for food safety, based
on the most recent science, that focuses efforts where the hazards are
reasonably likely to occur, and that is flexible and practical given
our current knowledge of food safety practices. To achieve this, FDA
has engaged in a significant amount of outreach to the stakeholder
community to find the right balance between flexibility and
accountability in these regulations.
    After FSMA was enacted in 2011, we have been involved in
approximately 600 stakeholder engagements on FSMA and the proposed
rules, including public meetings, Webinars, listening sessions, farm
tours, and extensive presentations and meetings with various

stakeholder groups (Refs. 2 and 3). As a result of this stakeholder
dialogue, FDA decided to issue the four supplemental notices of
proposed rulemaking to share our current thinking on key issues and get
additional stakeholder input on those issues. As we move forward into
the next phase of FSMA implementation, we intend to continue this
dialogue and collaboration with our stakeholders, through guidance,
education, training, and assistance, to ensure that stakeholders
understand and engage in their respective roles in food safety. FDA
believes these seven foundational final rules, when implemented, will
affect the paradigm shift toward prevention that was envisioned in FSMA
and be a major step forward for food safety that will help protect
consumers into the future.

B. What risks to humans and animals have been associated with the
transportation of food? How has this issue been addressed in the past?

    Due to illness outbreaks involving human food and animal food that
became contaminated during transportation (Refs. 4 and 5), and
incidents and reports of insanitary transportation practices (Refs. 6
to 11), there have been concerns over the past few decades about the
need to ensure that food is transported in the United States in a
sanitary manner (Ref. 12). Press accounts in the late 1980s of trucks
carrying food from the Midwest to both the East and West Coasts and
returning with garbage for Midwest landfills caused concern that food
products could become contaminated and unfit for human consumption if
irresponsible vehicle operators failed to properly clean vehicles that
had been previously used to haul waste or other nonfood materials
(Refs. 13 to 15). Congress responded to these concerns by passing the
Sanitary Food Transportation Act of 1990 (1990 SFTA) (Pub. L. 101-500),
which directed the Department of Transportation (DOT) to establish
regulations to prevent food or food additives transported in certain
types of bulk vehicles from being contaminated by nonfood products that
were simultaneously or previously transported in those vehicles.
Following the passage of the 1990 SFTA it became clear that potential
sources of food contamination during transport were not just limited to
nonfood products. Most notably, a 1994 outbreak of salmonellosis
occurred in which ice cream mix became contaminated during transport in
tanker trucks that had previously hauled raw liquid eggs. That outbreak
affected an estimated 224,000 persons nationwide (Ref. 4). In 2005,
Congress reallocated authority for food transportation safety to FDA,
DOT, and USDA by passing the 2005 SFTA, a broader food transportation
safety law than the 1990 SFTA. The focus of the 2005 SFTA was not
limited only to preventing food contamination from nonfood sources
during transportation.

C. What did the Sanitary Food Transportation Act of 2005 and the Food
Safety Modernization Act of 2011 do with respect to food
transportation? What other activities did we conduct for this
rulemaking?

    The 2005 SFTA directed us to establish regulations prescribing
sanitary transportation practices to be followed by shippers, carriers
by motor vehicle or rail vehicle, receivers, and other persons engaged
in the transportation of food. Section 111(a) of FSMA also directed FDA
to issue these sanitary transportation regulations. In April of 2010,
we issued guidance to provide the industry with broadly applicable
recommendations for controls to prevent food safety problems during
transport while we worked toward implementing the 2005 SFTA (Ref. 16).
We also published a Federal Register advance notice of proposed
rulemaking in 2010 (the 2010 ANPRM; 75 FR 22713, April 30, 2010) to
request data and information on the food transportation industry and
its practices to prevent the contamination of transported foods and any
associated outbreaks.

D. What did we propose to do?

    We subsequently published a proposed rule in the Federal Register
of February 5, 2014 (79 FR 7006), to establish sanitary transportation
requirements for shippers, carriers by motor vehicle and rail vehicle,
and receivers engaged in the transportation of both human and animal
food to ensure the safety of the food they transport.
    In brief, we proposed to address the sanitary transportation of
food for humans and animals by establishing definitions and criteria
that would apply to determine whether food is adulterated because it
has been transported or offered for transport by a shipper, carrier by
motor vehicle or rail vehicle, or receiver under conditions that are
not in compliance with the sanitary food transportation regulations. We
proposed to define transportation as any movement of food in commerce
by motor vehicle or rail vehicle. We proposed to establish requirements
for sanitary transportation practices applicable to shippers, carriers
by motor vehicle and rail vehicle, and receivers engaged in food
transportation operations. Specifically, we proposed to establish
requirements for:
     Vehicles and transportation equipment;
     Transportation operations;
     Training;
     Records; and
     Waivers.
    The proposed rule would allow the transportation industry to
continue to use best practices concerning cleaning, inspection,
maintenance, loading and unloading of, and operation of vehicles and
transportation equipment that it has developed to ensure that food is
transported under the conditions and controls necessary to prevent
contamination and other safety hazards.
    We received about 240 submissions in response to the proposed rule.
We received comments from individuals, industry and trade associations,
consumer and advocacy groups, academia, law firms, professional
organizations, Federal and State, tribal and foreign government
agencies and other organizations. In this document, we describe these
comments, respond to them, and explain any revisions we made to the
proposed rule in response to those comments. In addition, we held three
public meetings to discuss the proposed rule. The meetings took place
on February 27, 2014, in Chicago, IL; March 13, 2014, in Anaheim, CA;
and March 20, 2014, in Washington, DC.
    Some comments address issues that are outside the scope of this
rule. For example, a comment suggests that we undertake a comprehensive
examination of transportation that occurs by ship or barge within,
into, or out of the United States to provide Congress with sufficient
information to reevaluate our safe food transportation statutory
authority (see responses to Comment 9 and Comment 30). Another comment
states that this rule should identify the parties who are responsible
for paying attorney's fees in cases where claims are made for damage
that occurs during truck or rail transport of food. We do not discuss
these types of comments in this document.

II. What is the legal authority for this rule?

    We are issuing this rule under authority of the 2005 SFTA and as
directed by section 111(a) of FSMA.
    The 2005 SFTA amended the Federal Food, Drug, and Cosmetic Act (the
FD&C Act), in part, by creating a new section, 416 of the FD&C Act (21
U.S.C. 350e). Section 416(b) of the FD&C Act directs us to issue
regulations to require shippers, carriers by motor vehicle or rail
vehicle, receivers, and other persons

engaged in the transportation of food in the United States to use
prescribed sanitary transportation practices to ensure that food is not
transported under conditions that may render the food adulterated.
Section 416(c) of the FD&C Act specifies that we shall prescribe those
practices that we determine are appropriate relating to: (1)
Sanitation; (2) packaging, isolation, and other protective measures;
(3) limitations on the use of vehicles; (4) information to be disclosed
to carriers and to manufacturers; and (5) recordkeeping. Section 416(c)
of the FD&C Act also states that the regulations are to include a list
of nonfood products that may, if shipped in a bulk vehicle, render
adulterated food that is subsequently transported in the same vehicle,
and a list of nonfood products that may, if shipped in a motor vehicle
or rail vehicle (other than a tank vehicle or bulk vehicle), render
adulterated food that is simultaneously or subsequently transported in
the same vehicle. Section 111(a) of FSMA directed us to issue these
sanitary transportation regulations not later than 18 months after the
date of enactment of FSMA.
    In addition, the 2005 SFTA created new section 402(i) in the FD&C
Act (21 U.S.C. 342(i)) which provides that food that is transported or
offered for transport by a shipper, carrier by motor vehicle or rail
vehicle, receiver, or any other person engaged in the transportation of
food under conditions that are not in compliance with the regulations
issued under section 416 is adulterated. Also, new section 301(hh) in
the FD&C Act (21 U.S.C. 331(hh)) prohibits the failure by a shipper,
carrier by motor vehicle or rail vehicle, receiver, or any other person
engaged in the transportation of food to comply with the regulations
issued under section 416. The 2005 SFTA also amended section 703 of the
FD&C Act (21 U.S.C. 373) by adding section 703(b), which provides that
a shipper, carrier by motor vehicle or rail vehicle, receiver, or other
person subject to section 416 shall, on request of an officer or
employee designated by FDA, permit the officer or employee, at
reasonable times, to have access to and to copy all records that are
required to be kept under the regulations issued under section 416.
    FDA's authority for this rule is also derived from sections
402(a)(1), (2), and (4) and 701(a) of the FD&C Act (21 U.S.C. 371(a)).
Section 402(a)(1) of the FD&C Act provides, in part, that a food is
adulterated if it bears or contains any added poisonous or deleterious
substance, which may render it injurious to health. Section 402(a)(2)
of the FD&C Act provides that a food is adulterated if it bears or
contains any added poisonous or added deleterious substance (other than
a substance that is a pesticide chemical residue in or on a raw
agricultural commodity (RAC) or processed food, a food additive, a
color additive, or a new animal drug) that is unsafe within the meaning
of 21 U.S.C. 346; if it bears or contains a pesticide chemical residue
that is unsafe within the meaning of 21 U.S.C 346a(a); or if it is or
if it bears or contains (1) any food additive that is unsafe within the
meaning of 21 U.S.C. 348; or (2) a new animal drug (or conversion
product thereof) that is unsafe within the meaning of 21 U.S.C. 360b.
Section 402(a)(4) of the FD&C Act provides that a food is adulterated
if it has been prepared, packed, or held under insanitary conditions
whereby it may have become contaminated with filth, or whereby it may
have been rendered injurious to health. Under section 701(a) of the
FD&C Act, FDA is authorized to issue regulations for the efficient
enforcement of the FD&C Act. This rule includes requirements that are
necessary to prevent food from becoming unsafe, i.e., adulterated under
the aforementioned provisions of section 402 of the FD&C Act, due to
insanitary transportation practices. These requirements allow for the
efficient enforcement of the FD&C Act.

III. What general comments did we receive on the proposed rule?

A. Purpose of This Rule

    (Comment 1) We stated in the proposed rule that the goal of this
rulemaking is to ensure that transportation practices do not create
food safety risks and that this rule builds on current food transport
industry best practices. The rule is focused on ensuring that persons
engaged in the transportation of food that is at the greatest risk for
contamination during transportation follow appropriate sanitary
transportation practices. This rule allows the food transportation
industry to continue to use best practices concerning the cleaning,
inspection, maintenance, loading and unloading of, and operation of
vehicles and transportation equipment that it has developed to ensure
that food is transported under the conditions and controls necessary to
prevent contamination and other safety hazards.
    Several comments support our intent to provide shippers, loaders,
carriers and receivers with the flexibility to continue to utilize
appropriate sanitary transportation industry best practices. A comment
states that this approach allows companies to tailor their practices,
as appropriate and necessary, based on the nature of the food and the
transportation conveyance used, and to adopt new practices when there
are advances in technology. Other comments agree with many aspects of
the proposed rule, but conclude that some aspects need further
refinement to reflect current industry best practices.
    On the other hand, one comment states that this rulemaking is not
necessary and that the food transportation industry, instead, should be
given the flexibility to meet the standards placed upon it by the
shippers without undue interference, or rules and regulations, that
hinder the safe and efficient movement of human and animal food. One
comment states that there are no systemic food safety issues related to
the sanitary transport of food and that, therefore, this rulemaking is
unnecessary.
    (Response 1) As stated in the proposed rule, the SFTA requires FDA
to issue regulations requiring shippers, carriers by motor vehicle or
rail vehicle, receivers, and other persons engaged in the
transportation of food to use sanitary transportation practices to
ensure that food is not transported under conditions that may render
the food adulterated. We have met this mandate, in part, by
incorporating current best practices into this rule to the extent that
we believe they are effective in achieving the goal of this rule. We
disagree with the comments that stated this rule is unnecessary because
Congress found that there was an adequate need to mandate that FDA
issue these regulations in the 2005 SFTA and FSMA.

B. What regulatory approach should we take?

    (Comment 2) Several comments express concern that the proposed rule
applies the same requirements to human food and animal food. Many of
these comments state that we should issue a separate rule for the
sanitary transportation of animal food that is appropriately risk-based
and specific to the types of ingredients and manufacturing processes
used for animal food. Other comments state that we should distinguish
between sanitary transportation requirements for animal food and human
food in this rule to allow it to be reasonable and practical for the
animal food industry.
    (Response 2) We agree that this rule should more clearly recognize
that sanitary transportation practices may differ for different types
of food being transported to avoid confusion in its

interpretation and application. Accordingly, and as discussed in our
responses to Comment 89, we have revised the requirements of this rule
for vehicles and transportation equipment (Sec.  1.906), and for
transportation operations (Sec.  1.908), to make it clear that these
requirements take into account the intended use of the vehicle or
equipment, e.g., the transportation of animal feed. Also, as discussed
in our response to Comment 130, we have also revised the requirements
of this rule for transportation operations (Sec.  1.908) to state that
the type of food being transported, e.g., human food or animal feed,
must be considered in establishing the applicable sanitary
transportation practices.
    (Comment 3) One comment states that there are two distinct animal
food industries, the pet food industry, which employs standards and
practices equivalent or close to those used for human food, and the
animal feed industry, for which product is not normally handled with
the same equipment used for human food transportation operations. This
comment encourages us to recognize the significant difference between
the purpose and function of these two ``markets'' for animal food, so
that livestock feed transportation is not held to the same standards as
pet food transportation. A related comment encourages us not to
establish a pet food standard for all animal food and stated that the
final rule should not require significant conversion of equipment used
in animal feed sourcing and transport operations to pet food standards
which necessitate the use of stainless steel equipment.
    (Response 3) We agree that sanitary transportation practices for
pet food differ from those for animal feed. The revisions we have made
to this rule in Sec.  1.906 and Sec.  1.908, as explained in our
response to Comment 2, will allow practices employed for the transport
of pet food and animal feed to be appropriately tailored to the unique
needs of those operations. This rule, therefore, will not necessitate
the conversion of equipment used in animal feed operations to meet
standards for pet food.
    (Comment 4) Some comments suggest that produce safety could be
improved by establishing general requirements under the FSMA produce
safety rule for the transportation of produce after it leaves the farm,
if the farm assumes the role of either the shipper or the carrier.
These comments suggest that these FSMA produce safety requirements
should be similar to the practices outlined in the proposed rule for
the transport of food that can support the rapid growth of undesirable
microorganisms in the absence of temperature control. These comments
also state that, by covering produce under a transportation provision
in the FSMA produce safety rule, enforcement for sanitary
transportation practices would be performed by Agencies already tasked
with implementing the produce safety rule. One comment states that
regulating the transportation of produce in this manner would provide a
single source for compliance requirements and would likely reduce the
possibility that any requirements might be overlooked.
    (Response 4) The produce safety rule establishes science-based
minimum standards for the safe production and harvesting of fruits and
vegetables to minimize the risk of serious adverse health consequences
or death, focusing on the most important routes of on-farm
contamination of produce with biological hazards. By contrast this rule
requires persons engaged in the transportation of all foods, including
fresh fruits and vegetables, to use sanitary transportation practices
in their operations to ensure that food is transported under conditions
that prevent it from becoming unsafe. The sanitary transportation
practices required by this rule are not limited to those that address
potential contamination of food with biological hazards, they also
apply to other forms of contamination, e.g., with chemical and physical
hazards, that could cause food to become unsafe. We believe it is most
appropriate to establish requirements related to transportation of
produce after it leaves the farm in this rule.
    (Comment 5) One comment expresses concern that this rule's
requirements would apply uniformly across the entire U.S. food
transportation sector, despite the fact that current railroad industry
best practices have resulted in very few reported cases of foodborne
illnesses directly attributable to rail carriers. Another comment
asserts that we should defer issuing this rule as it applies to
railroads. It states that, in view of the absence of reported incidents
of insanitary food rail transportation and the existing rail industry
practices to prevent such incidents, applying the rule to the rail
industry is not necessary at this time.
    (Response 5) The 2005 SFTA directs us to issue regulations that
require shippers, carriers by motor vehicle or rail vehicle, receivers,
and other persons engaged in the transportation of food to use sanitary
transportation practices to ensure that food is not transported under
conditions that may render the food adulterated. We are issuing this
rule as directed by Congress. It is unlikely carriers who have
successfully employed best practices for food transportation, whether
they be motor or rail carriers, will need to alter their transportation
practices significantly to comply with this rule, although we
acknowledge that there are new costs associated with training and
recordkeeping.
    (Comment 6) One comment identifies smaller box trucks making local
deliveries as a particular sanitary food transport problem. The comment
states that most of the instances where food transportation problems
were found in the 2007 Interstate Food Transportation Assessment
Project study (Ref. 6) involved smaller box trucks as discussed in the
proposed rule (79 FR 7006 at 7008). The comment suggests that FDA
develop an enforcement plan focused on smaller box trucks engaged in
local food delivery operations.
    (Response 6) As we implement this rule, we will work with our
partners, i.e., DOT, and State, local, territorial and tribal
officials, to direct our efforts to address the areas of greatest need
with respect to practices that create potential food safety risks for
local deliveries. To the extent that smaller box trucks making local
deliveries fall below the ``Non-Covered Business'' cutoff of $500,000,
we note that these trucks remain subject to the provisions, including
the adulteration provisions, of the FD&C Act with regard to their
transport of food.
    (Comment 7) One comment states that the provisions of this rule are
not specific and so broad based that they should be viewed only as non-
binding recommendations. It further asserts that the only way we can
protect the food supply is by implementing enforceable laws like the
Sanitary Food Transportation Act of 1990 and that DOT already has a
system in place in which vehicles are inspected wherein they could use
an F (signifying food vehicle) on the inspection sticker of the trucks
and trailers that transport food.
    (Response 7) We reject this interpretation of this rule. The
provisions of this rule are not guidance nor are they recommendations.
Many of the requirements established in this rule address broadly
applicable procedures and practices intended to provide flexibility for
shippers, loaders, carriers, and receivers to comply with the
requirements in a way that is most suitable for their practices, as
many are already implementing the industry best practices on which the
rule is based. Furthermore, Congress enacted the 2005

SFTA to grant FDA, DOT, and USDA shared responsibility over regulating
the sanitary transportation of food.

C. How does this rule relate to other FSMA rules?

    (Comment 8) Several of the comments express a preference for the
farm definition in the proposed transportation rule over the
definitions in other FSMA proposed rules because it does not limit the
facility's activities to the packing and holding of a farm's own food.
These comments recommend that we apply the sanitary transportation
rule's farm definition throughout all of the FSMA rules. Conversely,
another comment suggests that we use different definitions for entities
such as ``farms'' in the various FSMA rules, allowing us to take a
customized approach to each specific rule.
    (Response 8) We agree that using a definition of the term ``farm''
in this rule that, to the extent practicable, is aligned with this term
as defined in other FDA regulations, including the regulations we have
established under FSMA, would be functionally efficient for us and for
stakeholders. We explained in the proposed rule that we tentatively
defined the term ``farm'' differently than it was defined in 21 CFR
1.227(b)(3), which is used to establish which facilities are required
to register under section 415 of the FD&C Act (21 U.S.C. 350d), because
21 CFR 1.227(b)(3) applies only to facilities that pack or hold food if
the food used in such activities is grown, raised, or consumed on that
farm or a farm under the same ownership. We had tentatively concluded
that the sanitary transportation practices that would be required by
our proposed rule would not be necessary to prevent RACs from becoming
adulterated during transportation by farms, regardless of whether the
farms are conducting transportation operations for RACs that were
grown, raised, or consumed on the same farm or on another farm under
different ownership. We therefore tentatively concluded to use a
different definition of the term ``farm'' for purposes of this
rulemaking.
    In the FSMA preventive controls for human food final rule (80 FR
55908 at 55925), we revised our definition of the term ``farm'' in 21
CFR 1.227 to clarify the types of activities that are included as part
of the definition of the term ``facility'' and to clarify the scope of
the exemption from the registration requirement for ``farms''
established in section 415 of the FD&C Act. This revised definition no
longer requires that farms that pack or hold food only carry out these
activities for food that was grown, raised, or consumed on that farm or
a farm under the same management. This revised definition now governs
the applicability of the provision in this final rule that excludes
transportation operations performed by farms from coverage under this
rule. We, therefore, have aligned this rule with the revised definition
of the term ``farm'' in 21 CFR 1.227 by revising 21 CFR 1.904 to state
that this term has the new meaning contained in 21 CFR 1.227. This
action also aligns the definition in this rule with this term as
defined in other FSMA rules, i.e., the preventive controls rule for
animal food and the produce safety rule.
    (Comment 9) One comment urges us to create a party with the same
responsibilities as the ``importer'' in the FSMA Foreign Supplier
Verification Programs for Importers of Food for Humans and Animals
(FSVP) rule who would be responsible for verifying that the practices
of foreign suppliers are in compliance with our regulations. The
comment states that this person would be responsible for verifying the
safe transportation of imported products before and after the products
arrive in the United States. The comment explains that in the preamble
to the FSVP proposed rule, we stated that the person responsible for
verifying the safety of the foreign supplier ``has a direct financial
interest in the food and is most likely to have knowledge and control
over the product's supply chain.'' The comment asserts that for
imported food, the safety of the food transport is inextricably linked
with the safety of the supply chain, starting with the foreign
supplier. The comment further states that the person with a direct
financial interest in the food product is the party most likely to have
the knowledge and control necessary to ensure not just the safety of
the foreign supplier, but also the safety of the transportation after
the food arrives in the United States. The comment argues that there
should be consistency between these two rules for imported products.
    (Response 9) The 2005 SFTA direct us to issue regulations to
require shippers, carriers by motor vehicle or rail vehicle, receivers,
and other persons engaged in the transportation of food in the United
States to use prescribed sanitary transportation practices to ensure
that food is not transported under conditions that may render the food
adulterated. It does not direct us to establish requirements for the
transport of food destined for the United States before it reaches the
United States. Shipments of food destined for consumption in the United
States remain subject to the provisions of the FD&C Act, including the
adulteration provisions.
    (Comment 10) One comment states that the treatment of small
businesses in the FSMA rules is not consistent. The comment states that
modified requirements, compliance dates, and exemptions have been based
on annual sales throughout the FSMA proposed rules, but the annual
sales metrics have not been consistent, i.e., the rules have addressed
business size alternatively on the basis of total annual sales, rolling
averages of total annual sales, numbers of employees, total annual food
sales, and total sales in combination with qualified end user sales.
The comment recommends that we create a simpler, consistent approach so
that businesses can clearly discern whether they must comply with the
regulations.
    (Response 10) The only provisions of this final rule that are
related to the business size or business volume are the number of
employees threshold for businesses, other than carriers by motor
vehicle, in the definition of a ``small business,'' the annual receipts
threshold for carriers by motor vehicle in the definition of a ``small
business,'' and the annual revenue threshold in the definition of a
``non-covered business.''
    With respect to the number of employees threshold for businesses
that are not carriers by motor vehicle, as explained in the proposed
rule (79 FR 7006 at 7014) and the discussion of this definition in
section IV.C. of this final rule, this provision is based upon the size
based standard (expressed in terms of numbers of employees) that has
been established by the U.S. Small Business Administration under 13 CFR
121.201 for most food manufacturers. This provision of the ``small
business'' definition incorporates the same size based standard as we
included in the preventive controls final rules for human and animal
food.
    With respect to the annual receipts threshold for small businesses
that are motor carriers, as explained in the proposed rule (79 FR 7006
at 7014) and the discussion of this definition in section IV.C. of this
final rule, this provision is based upon the size based standard of the
U.S. Small Business Administration for truck transportation firms in 13
CFR 121.201. This provision of the ``small business'' definition is
unique to this rule and has no relation to other FSMA rules, because
only this rule establishes requirements for carriers.
    With respect to the annual revenue threshold in the definition of a
``non-covered business,'' as we state in our response to Comment 62, we
proposed

to establish this provision, in part, to treat firms subject to this
rule comparably to those firms that are subject to FSMA preventive
controls rules. As also explained in the discussion of this definition
in section IV.C., we have revised this definition in this final rule to
apply the same method for calculating a firm's annual revenue that we
used in very small business definitions of the preventive controls
rules.
    (Comment 11) One comment states that we did not address the issue
of routine security measures, such as the use of truck seals, in the
proposed transportation rule and other proposed FSMA rules. The comment
states that these measures provide a benefit in transportation similar
to that of underlying prerequisite programs in the context of a food
manufacturer's hazard analysis and critical control point (HACCP)
system. The comment further states that these measures need to be
addressed by the FSMA rules to ensure that potential contamination
risks (that do not rise to the level of the massive, catastrophic
threats that are the subject of the proposed FSMA intentional
adulteration rule) are addressed.
    (Response 11) This suggestion is outside the scope of this
rulemaking. We agree that persons engaged in food transportation should
consider the use of routine security measures. We have issued guidance
on this subject: ``FDA Guidance on Food Security Preventive Measures
for Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations,
and Fluid Milk Processors;'' and ``FDA Guidance on Food Security
Preventive Measures for Food Producers, Processors, and Transporters''
(Refs. 17 and 18). However, the purpose of this rule is to establish
sanitary transportation practices to be used by shippers, carriers by
motor vehicle and rail vehicle, receivers, and other persons engaged in
food transportation to ensure that food is not rendered adulterated
during transportation, which is distinct from the issue of the security
of food transportation. FDA will be addressing food defense concerns in
its upcoming final rulemaking on Intentional Adulteration; however, to
the extent that certain food defense issues are not covered in the FSMA
rulemakings, and it becomes apparent as we implement the rules that
there are food defense concerns that would benefit from additional
regulation, we will consider initiating such rulemakings in the future.

D. Effect of Other Statutes on the Applicability of This Rule and How
This Rule Affects Food Regulated by Other Federal Agencies

    (Comment 12) Several comments note that FDA lacks jurisdiction over
meat, poultry, and egg products within meat, poultry, and egg product
establishments that are subject to USDA regulation and inspection by
USDA's Food Safety and Inspection Service (FSIS) under the Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601 et seq.), the Poultry Products
Inspection Act (PPIA) (21 U.S.C. 451 et seq.), and the Egg Products
Inspection Act (EPIA) (21 U.S.C. 1031 et seq.). Some of these comments
ask us to explicitly acknowledge in this rule that USDA has exclusive
jurisdiction over meat, poultry, and egg products operations conducted
in these establishments and over the meat, poultry, and egg products up
until the time these food products leave these establishments. They
also observed that the requirements of this rule would only apply to
meat, poultry, and egg products after they have left the FSIS-inspected
establishments and, therefore, that the requirements of this rule only
apply to carriers as they transport meat, poultry, and egg products and
receivers of those products, provided that the receiver is not
exclusively inspected by FSIS.
    In addition to the FDA-USDA jurisdictional issue, some comments
state that a new layer of FDA sanitary food transportation regulation
is unnecessarily duplicative with respect to the meat and poultry
industries because meat and poultry establishments are already subject
to FSIS regulations that address the transportation of meat and poultry
products (see, 9 CFR part 325 and 9 CFR part 381, subpart S), as well
as by guidance issued by USDA. These comments also state that FSIS's
existing meat and poultry safety regulations and oversight activities
are adequate and sufficiently robust, and are based on established
industry best practices. Another comment suggests that we should
dispense with any unnecessarily duplicative sanitary food
transportation regulation of meat, poultry, and egg products by issuing
a waiver, as provided for under this rule, or by establishing a
Memorandum of Understanding (MOU) with FSIS that provides for FSIS to
regulate transportation of these products from FSIS-regulated
facilities.
    (Response 12) We agree that FDA lacks jurisdiction for meat,
poultry, and egg product activities that occur within meat, poultry,
and egg product processing facilities regulated exclusively by USDA. We
have consulted with USDA and modified Sec.  1.900(b) in this rule by
adding a third category of persons exempt from the requirements of this
subpart. In this final rule, Sec.  1.900(b)(3) excludes shippers,
loaders, receivers, or carriers when they are engaged in transportation
operations of food while the food is located in food facilities as
defined in Sec.  1.227, that are regulated exclusively, throughout the
entire facility, by the U.S. Department of Agriculture under the FMIA,
the PPIA, or the EPIA. However, there are dual jurisdiction
establishments that prepare, pack, hold, or otherwise handle both foods
regulated by USDA and foods regulated by FDA. In the case of dual
jurisdiction establishments, FDA would inspect in accordance with its
existing MOU with USDA (Ref. 19).
    In addition, we did not tentatively conclude in the proposed rule
that USDA guidance on the safe transportation and distribution of meat,
poultry, and egg products is not adequate to ensure their safety.
Rather, we stated that FSIS does not have requirements that directly
address transportation operations for these foods once they leave FSIS-
inspected facilities. However, FSIS has regulations that require that
FSIS-regulated establishments to address sanitation during
transportation, e.g., 9 CFR 416.4(d) and 9 CFR 417.2(a)(1), and this
rulemaking will complement FSIS's efforts to promote the application of
sanitary food transportation practices for FSIS-regulated meat,
poultry, and egg products.
    (Comment 13) One comment opposes applying the sanitary food
transportation rule to shell eggs on the grounds that the
transportation of shell eggs is already regulated by FDA under 21 CFR
part 118, and that the transportation of egg products is already
regulated by USDA under requirements established under the EPIA. The
comment further states that most shell egg producers also are subject
to additional transportation safeguards either because of customers'
proprietary specifications or customers' requests that the egg
producers participate in voluntary quality-assurance programs, such as
the Safe Quality Food (SQF-2000) standards or the United Egg Producer's
5-Star Egg Safety Program.
    (Response 13) We disagree with this comment. The transportation
requirements in 21 CFR part 118 address only the ambient temperature of
vehicles used to transport shell eggs and do not include requirements
for the design, condition, and sanitation of the vehicles or specific
procedures to

ensure that the specified temperatures are consistently achieved.
Similarly, USDA's requirements for the transportation and storage of
eggs packed for the ultimate consumer (9 CFR 590.50) refer only to the
ambient temperature at which shell eggs must be stored and transported.
By contrast, this rule addresses the design, condition, and sanitation,
as well as the temperature, of vehicles used to transport food.
    With regard to customers' specifications and quality assurance
programs, many types of foods are subject to customers' transportation
specifications and quality assurance programs. However, we cannot rely
on them, exclusively and under all circumstances, to keep food safe
during transportation because they vary in effectiveness and are not
uniformly administered. This rule establishes uniform, nationwide
requirements for the sanitary transportation of food, including shell
eggs. To the extent that transportation practices are covered under egg
quality assurance programs, these egg producers should find it easier
to comply with our requirements.
    (Comment 14) A few comments ask us to amend this rule to clarify
that under section 116(a) of the FSMA, a facility engaged in the
manufacturing, processing, packing, or holding of beverage alcohol
products is exempt from this rulemaking. The comments also suggest that
we should exempt the transport of all bulk or packaged beverage alcohol
products from this rule, including the transport of ingredients and the
co-products or by-products of beverage alcohol manufacture. The
comments state that the language of section 116 of FSMA specifies which
sections of the statute apply to a facility engaged in the
manufacturing, processing, packing, or holding of one or more beverage
alcohol products, and note that unless a rule falls under sections 102,
206, 207, 302, 304, 402, 403 or 404 of FSMA, Congress does not intend
for it to apply to a facility engaged in manufacturing, processing,
packing, or holding beverage alcohol products. The comments further
assert that because section 111(a) of the FSMA, which directs us to
issue this rule, is not one of the listed sections, a facility that is
exempt under section 116 should also be exempt from the sanitary food
transportation rule. Some of the comments also state that we should
exempt the transport of alcoholic beverage products, as well as any
oversight of their production facilities, from this rule to avoid
duplicative regulatory schemes implemented by both FDA and the U.S. Tax
and Trade Bureau (TTB).
    (Response 14) There is nothing in FSMA that indicates that
transportation operations for beverage alcohol should be exempt from
the requirements of this rule. Section 111(a) of the FSMA only creates
a deadline for the implementation of the 2005 SFTA final rule, and
nothing in the FSMA otherwise addresses the 2005 SFTA. Therefore, it
seems that, based on a plain reading of the statute, transportation
operations for beverage alcohol can be covered by this rule. In
addition, we are not aware of TTB regulatory requirements that would
duplicate the requirements of this rule. However, this final rule, as
provided under the revised definition of ``transportation operations''
in Sec.  1.904, does not apply to the transportation of food fully
enclosed by a container that does not require temperature control to
prevent it from becoming unsafe. This provision essentially excludes
packaged beverage alcohol products from coverage under this rule.
    (Comment 15) One comment asks that we consider issues regarding the
rejection of produce shipments under this rule that are also subject to
the Perishable Agricultural Commodities Act (PACA). The comment states
that under the PACA, sellers and buyers must legally ship and accept
the quantity and quality of produce specified in their contracts, and
receivers must accept produce that is damaged and decayed, up to a
certain percentage, depending on the product's grade standards. The
comment contemplates a situation where a receiver would be required to
accept shipments under the PACA, but, according to the comment, might
be required to reject them under this rule for deviation from quality
standards set by the shipper.
    (Response 15) This rule does not require a receiver to reject a
shipment that is transported under conditions that deviate from those
specified by the shipper to the carrier and loader in accordance with
Sec.  1.908(b)(1). As explained in our response to Comment 129, the
rule establishes requirements for shippers, loaders, carriers, and
receivers in Sec.  1.908(a)(6) that precludes the sale or distribution
of any food subject to this rule where there is an indication of a
material failure of temperature control or other conditions during
transportation that may render the food unsafe, unless a determination
is made by a qualified individual that the temperature deviation or
other condition did not render the food unsafe. Contrary to the
comment's assertions, this rule does not address the disposition of any
produce delivered to a receiver that might deviate from quality
standards set by a shipper.

E. Other Comments

1. Contractual Reassignment
    (Comment 16) Several comments asserted that, to reflect common
industry practice, we should explicitly recognize that companies that
bear legal responsibility for compliance with this rule may
contractually assign specific tasks, e.g., vehicle inspections or
taking a temperature measurement, to an alternative or better suited
entity. Several comments state that we acknowledged the potential for
parties to contractually allocate tasks in the preamble discussion of
the proposed rule (79 FR 7006 at 7014) and that we should explicitly
recognize in the final rule that shippers, carriers, and receivers may
enter into contracts that allocate tasks either between them or to
another entity. For example, one comment states that a carrier should
be able to rely exclusively on a receiver to take the temperature of a
refrigerated food load upon delivery to assess the potential for
temperature abuse during transport given that the receiver may already
be engaging in this activity for its own purposes. Several comments
state that firms that contractually reassign tasks should maintain
records that FDA could review during inspections to document these
contractual agreements. One comment states that there may be entities
involved in food transportation other than those that would be subject
to the proposed rule, such as warehouses, that might contractually
assume some of the requirements described in the proposed rule.
    (Response 16) We acknowledge that industry practice is to alter, by
contract, the tasks assigned to shippers, loaders, carriers, and
receivers in this rule. Therefore, we also explicitly recognize that
companies that bear legal responsibility for compliance with this rule
may contractually assign specific tasks, e.g., cleaning a vehicle or
communicating previous loads hauled, to an alternative entity. We also
understand that industry best practice is to memorialize the assignment
of duties in a transportation operation with a written contract.
    The duty to comply with the provisions in this rule can be
reassigned via contract among parties covered by this rule (e.g., as
described in Sec.  1.908(b)(5) where the shipper assigns
responsibilities such as monitoring temperature during transit via
written

contract to a carrier). We have further clarified this point by adding
language at Sec.  1.908(a)(1) that states that an entity subject to
this rule (shipper, loader, carrier, or receiver) may reassign, in a
written agreement, its responsibilities under this rule to another
party subject to this rule. This provision also states that the written
agreement is subject to the records requirements of Sec.  1.912.
Further, parties may accomplish their duty to comply with provisions in
this rule by assigning tasks to parties not covered by this rule, as
long as such assignment is covered by a written contract (e.g., a
carrier may contract with a truck wash station to wash a bulk tanker,
where the truck wash station is not an entity that is covered by this
rule). If responsibility under this rule is assigned via contract to
another party covered by this rule (first example, aforementioned), FDA
would consider the terms of the contract in determining who is
responsible for compliance. If a task under this rule is assigned via
contract to a party who is not covered by the rule (second example,
aforementioned), FDA would hold the party covered by the rule
ultimately responsible for compliance with the provisions of the rule.
Any written agreements assigning duties in compliance with this rule
will be subject to the recordkeeping provisions in Sec.  1.912.
2. Intrastate Transportation
    (Comment 17) One comment states that the application of this rule
to both intrastate and interstate shipments would create consistent
expectations among parties engaged in food transportation. Furthermore,
the comment suggests that we consider addressing in this rule a common
practice among the parties engaged in food transportation whereby they
engage in a separate contract for the transportation of food, as
authorized by 49 U.S.C. 14101(b). The comment states that because there
is currently no standard transportation contract, parties are free to
agree to any and all terms that they choose, and the various State laws
apply to those terms. Further, the comment asked whether parties can
shift responsibilities, agree to terms more or less onerous, and change
the meaning of this rule by contract. The comment states that we should
clarify whether the rule cannot be modified by contract or specify what
parts can be modified. The comment also states that leaving these
questions unsettled in the final rule might result in numerous State
contract claims related to this rule.
    (Response 17) We agree that the application of this rule to both
intrastate and interstate shipments would create consistent
expectations among parties engaged in food transportation.
    Further, we acknowledge that under the provisions of 49 U.S.C.
14101(b), carriers by motor vehicle may ``expressly waive any and all
rights and remedies under [that] part for transportation covered [by a
contract between that carrier and a shipper].'' However, the purpose of
this rule is not to address the ability of parties to contract under
that provision. The purpose of this rule is to ensure that shippers,
loaders, carriers, and receivers use practices that ensure the sanitary
transportation of human and animal food. Therefore, as discussed in the
previous comment, the roles being played by the particular parties
involved in the transportation of food can be shifted among the parties
within the contractual relationship However, entities covered by this
rule cannot, via contract or otherwise, either change the meaning of
the rule or establish sanitary transportation requirements that are
less onerous than those contained in this rule.
    (Comment 18) One comment states that intrastate activities should
be exempt from the requirements of this rule. It asserts that the
paperwork burden required by this rule would be onerous for local bulk
animal feed facilities and that complying with this rule would make it
difficult for these types of facilities to remain in business. The
comment further states that the intrastate transportation of commercial
animal feed historically has presented little to no risk to humans and
animals.
    (Response 18) We disagree that intrastate transportation activities
should be exempt from this rule. As we noted in the proposed rule,
section 416(b) of the FD&C Act directs us to create regulations to
require shippers, carriers by motor vehicle or rail vehicle, receivers,
and other persons engaged in the transportation of food to use sanitary
transportation practices prescribed by the Secretary to ensure that
food is not transported under conditions that may render the food
adulterated. The scope of section 416(b) is not limited to interstate
commerce. We are sensitive to the concerns voiced by this comment about
the burden this rule might impose upon small facilities. As we discuss
in sections IV.E.2 and 5, we have revised the requirements regarding
the exchange of information between shippers and carriers (Sec.
1.908(b) and (e)), which in many cases will reduce or eliminate
paperwork burdens imposed on parties subject to this rule, including
facilities engaged exclusively in the intrastate shipment of bulk
animal feed. In addition, feed facilities engaged in intrastate
transportation operations are not subject to this rule if they are a
``non-covered business'' as defined in this rule. This final rule
establishes appropriate requirements for such facilities and will not
impose undue cost or paperwork burdens. Since the rule has its basis in
industry best practices, many persons should be in substantial
compliance with its provisions and should not find compliance
burdensome. Accordingly, this comment does not persuade us that it
would be appropriate or in keeping with the purpose of this statute to
exclude intrastate activities from the scope of this rule.
3. Enforcement Issues Related to This Rule
    (Comment 19) We received many comments regarding the enforcement of
this rule. The comments cover a broad range of topics, such as: The
need for clarification of the roles of various Agencies including DOT
and State and local regulatory authorities in enforcing the rule; FDA's
need to establish enforcement partnerships with other Agencies; how
variations in the applicability of this rule (e.g., those entities that
are subject to the rule and those that are not, and the effects of the
varying size of the entities covered by the rule) will be addressed;
whether enforcement during transportation, as opposed to at points of
origin and destination, is practical and/or necessary to ensure food
safety; how enforcement actions might vary depending on the severity of
a violation and the potential threat posed to food safety resulting
from a violation; the training that inspectors will likely need to
properly enforce this rule; how inspections will be carried out without
compromising the safety of the food shipment; and the need for
enforcement guidance for industry. Some comments express concern about
unequal enforcement of this rule directed toward trucking as compared
to railroad operations, because regulators can more readily develop and
execute truck surveillance and inspection programs. Comparable
surveillance and inspection activities are more difficult for railroad
operations, e.g., access to rail yards may be more limited and trains
cannot be stopped for inspection during transit. One comment addresses
the importance of ensuring that enforcement has a minimal impact on
international trade, especially in the case of rail carriers operating
between the United States, Canada, and Mexico. Some comments express
concern that we currently lack the resources to carry out inspections

and that we will face staffing and training challenges in
operationalizing this rule to achieve consistent enforcement of the
rule.
    (Response 19) The Secretary of Transportation, in consultation with
the Secretary of Health and Human Services and the Secretary of
Agriculture, is required by section 5701(a)(1) of the 2005 SFTA to
establish procedures for transportation safety inspections to identify
suspected incidents of contamination or adulteration of: Food in
violation of regulations issued under section 416 of the FD&C Act;
carcasses, parts of carcasses, meat, meat food products, or animals
subject to detention under section 402 of the FMIA (21 U.S.C. 672) and
the DOT's food transportation safety inspection requirements that
appear at 49 U.S.C. 5701; and poultry products and poultry subject to
detention under section 19 of the PPIA (21 U.S.C. 467a). The 2005 SFTA
further states in section 5701(b) that the Secretary of Transportation
shall promptly notify the Secretary of Health and Human Services or the
Secretary of Agriculture, as applicable, of any instances of potential
food contamination or adulteration of a food identified during DOT
transportation safety inspections. We note that DOT and USDA have
jointly produced a training video, entitled ``Considerations for the
Safe Transportation of Food Video,'' that is available via the
Department of Homeland Security at the University of Tennessee
Knoxville's Web site: http://www.vet.utk.edu/cafsp/online/ftsvideo.php.
DOT also has trained its enforcement officers to report any food safety
violation they encounter to FDA or USDA, depending on the nature of the
food being transported. We will work with DOT to support these
inspection efforts. However, we note that while DOT has authority to
conduct transportation safety inspections for the purpose of
identifying suspected incidents of food shipments that are not in
compliance with this rule and is authorized by section 416(f) of the
FD&C Act to provide assistance upon request by FDA in the enforcement
of this rule, FDA will generally be responsible for taking action when
food or persons are found to be in violation of the statutes and
regulations it administers.
    We intend to allocate our resources for the enforcement of this
rule by following up on information that DOT provides us or by
initiating inspections and investigations. These comments raise issues
that we will consider when developing enforcement strategies. The
details of our prospective enforcement strategies, however, are beyond
the scope of this rulemaking; however we believe that the impact of our
enforcement activities upon international trade will be minimal since
this rule allows the transportation industry to continue to use
existing practices that have proven to be effective for the safe
transportation of food. We know that we will need to address staffing
and training needs, and we will seek to establish partnerships with
other Federal Agencies and with State, local, and tribal governments to
implement this rule. We also will communicate with the public,
including with regulated industry, as appropriate, throughout the
process of developing and implementing our enforcement efforts for this
rule.
4. Intra-Corporate Operations
    We received several comments asking us to include provisions in
this final rule for food transportation operations that are conducted
under the ownership or operational control of a single corporate/legal
entity, i.e., food shipments involving shippers, loaders, carriers,
and/or receivers that are corporate subsidiaries or affiliates of a
common corporate parent company/legal entity. The comments refer to
these types of activities alternatively as ``intra-corporate'' or
``intra-company'' food transportation operations.
    (Comment 20) Several comments state that intra-corporate
transportation operations should be completely and expressly exempt
from this final rule. Some of these comments suggest that we should
define the term intra-corporate/intra-company in Sec.  1.904 of the
final rule and exempt these types of activities from the definition of
``transportation operations'' as that term is defined in Sec.  1.904.
Some of the comments ask us to exempt intra-corporate transportation
operations by issuing a waiver as provided for under Sec. Sec.  1.914
and 1.916 of this final rule. Most of these comments assert that intra-
corporate shipments typically are conducted in accordance with
integrated, intra-corporate Standard Operating Procedures (SOPs) and
good sanitary food transportation practices and therefore should be
exempt from the final rule. Some of the comments argue that food
transportation operations that are predominantly, but not entirely
intra-corporate, for example, in which a shipper and a receiver share a
common corporate ownership, but in which the loader or carrier might be
an independent, third-party entity operating under a contract with the
shipper, also should be entirely and expressly exempt from this final
rule.
    Some of these comments assert that we should exempt intra-corporate
food shipments from this rule because we contemplated exempting
similarly situated entities under our FSMA FSVP proposed rule (78 FR
45730 at 45743). Two comments argue that exempting all intra-corporate
food transportation operations from this rule is warranted because
intra-corporate transfers would be addressed under the FSMA preventive
controls rules for human and animal food. These comments assert that
subjecting intra-corporate shipments to additional regulation and
recordkeeping requirements under this sanitary food transportation rule
therefore would be unnecessary and redundant.
    One of the comments observes that the SFTA of 2005 and Sec.  1.904
of the proposed rule define the term ``transportation'' to mean ``any
movement in commerce by motor vehicle or rail vehicle.'' The comment
asserts that intra-corporate food shipments therefore should be exempt
from this rule because, for example, food shipped between facilities
owned, leased, or operated by the same corporate entity ``does not
enter the stream of commerce.''
    (Response 20) We decline to establish a blanket exemption from all
of this rule's requirements for food transportation operations that are
conducted between shippers, loaders, carriers, and/or receivers that
are part of the same corporate/legal entity either by revising the
definition of ``transportation operations'' in the final rule, by
issuing a waiver for intra-corporate shipments, or by any other
mechanism. We conclude that the fact that shippers, loaders, carriers,
and/or receivers may be operating within a unified corporate/legal
entity or sanitary food transportation system does not necessarily
ensure that all of the involved parties are operating in compliance
with the portions of section 402 of the FD&C Act that are relevant to
this rulemaking. While we acknowledge that parties involved in intra-
corporate food transportation operations can lessen their recordkeeping
burden by adopting a unified, company-wide approach to sanitary food
transportation operations, e.g., by creating comprehensive SOPs that
are to be followed by shippers, loaders, carriers, and/or receivers
that operate under common corporate ownership or control, such unified,
company-wide SOPs must ensure that the food is transported in
compliance with the requirements of this final rule. We address the use
of contracts to assign specific food transportation tasks to
independent, third parties in our response to Comment 16.

    In the FSVP final rule, we declined to establish ``an exemption
from the FSVP requirements for food that an importer obtains from a
foreign supplier that is part of the same corporate structure as the
importer,'' and we further declined ``to establish an exemption from
the FSVP requirements where the foreign supplier and importer may
otherwise be affiliated, and where the foreign supplier and importer
are part of the same company-wide `approach' to food safety'' (80 FR
74225 at 74255-56).
    We also decline to exempt intra-corporate food transportation
operations from this rule on the grounds that such activities will be
covered by the requirements of the preventive controls rules for human
and animal food. The primary purpose of the preventive controls rules
is to establish modern science- and risk-based preventive controls
requirements for the manufacturing, processing, packing, or holding of
human and animal food. Although facilities under the preventive
controls rules may identify refrigeration during transport as a
preventive control, for example, the preventive controls rule, unlike
this final rule, does not directly regulate carriers. We also note that
SFTA was signed into law in 2005 and FSMA was signed into law in 2011.
If Congress had intended for FSMA's preventive controls rules to
supplant the sanitary food transportation statutory requirements set
forth in SFTA under any circumstances, including but not limited to
intra-corporate food shipments, Congress presumably would have stated
so explicitly in FSMA's statutory language.
    Finally, we also decline to completely exempt intra-corporate food
transportation operations from this final rule on the commenter's
theory that food shipments between shippers, loaders, carriers, and/or
receivers that share a common corporate ownership do not fall within
the rule's definition of ``transportation'' because such food shipments
do not enter the stream of commerce. Although not explicitly stated in
the comment that asserts this theory, the comment appears to suggest
that the shipment of food between entities that operate under a common
corporate ownership or control does not enter into the stream of
``commerce'' presumably because the food is not being offered for sale
between the parties involved in the transportation operations. We
conclude that this interpretation of the 2005 SFTA's statutory
definition and the parallel definition of ``transportation'' in Sec.
1.904 of this final rule is incorrect. The 2005 SFTA does not define
the term ``in commerce'' and therefore does not explicitly limit the
scope of the rule, for example, only to those transportation operations
that involve the shipment of food that is offered for sale.
    (Comment 21) We received several comments asking us to apply
modified requirements regarding this rule's information sharing and
recordkeeping provisions to shippers, loaders, carriers, and/or
receivers engaged in intra-corporate food transportation operations.
These comments state, for example, that to require a shipper under this
rule that owns its own carrier fleet to provide to the carrier, in
writing, all necessary sanitary requirements for the carrier's vehicles
and transportation equipment would be redundant and serve no purpose
because the information sharing required by this rule, under these
circumstances, would presumably already be established by written
intra-corporate food transportation SOPs.
    Some of these comments assert that a precedent for exempting intra-
corporate food shipments from the information sharing and recordkeeping
provisions of this rule can be found in the recordkeeping final rule
that we issued under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (Bioterrorism Act), at 21 CFR
part 1, subpart J.
    (Response 21) We agree with these comments and have revised the
regulatory text accordingly. Section 1.908(a)(5) of this final rule
stipulates that as an alternative to meeting this rule's applicable
requirements, shippers, receivers, loaders, and carriers that are under
the ownership or operational control of a single legal entity may
conduct transportation operations in conformance with common,
integrated, written procedures that ensure the sanitary transportation
of food consistent with the rule. Section 1.908(a)(5) also states that
these written procedures are subject to the records requirements of
this rule in Sec.  1.912, which are discussed in section IV.G of this
document.
    Finally, as we already mentioned earlier in this document, some of
the comments invoked the Bioterrorism Act recordkeeping rule as a
precedent for granting the revised information sharing and
recordkeeping requirements of this rule for intra-corporate food
transportation operations. As we explained in the preamble to the
Bioterrorism Act recordkeeping rule, ``intra-corporate'' interactions,
for purposes of the implementation of that rule, are limited to
interactions between entities that are part of a ``vertically
integrated company,'' for example, a food manufacturer that owns its
own suppliers, carriers, distributors, and food retail outlets and,
therefore, never releases the food to persons outside of its vertically
controlled production path (69 FR 71562 at 71568-71569, December 9,
2004).
    The definition of a vertically integrated company as used in the
Bioterrorism Act recordkeeping rule is narrower in scope than the
definition of ``intra-corporate'' in this rule. As we explain in our
February 2012 guidance to industry entitled ``Questions and Answers
Regarding Establishment and Maintenance of Records by Persons Who
Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or
Import Food (Edition 5)'' (Ref. 20), two corporate entities that have
the same controlling corporate parent are not always part of a
vertically integrated company. They may be legally distinct persons,
for example, and therefore would not be exempt from the Bioterrorism
Act rule's recordkeeping requirements. Similarly, two corporate
subsidiaries that are legally distinct persons, but that are managed
operationally as a single entity, would not be exempt from the
Bioterrorism Act recordkeeping rule. We conclude that the information
exchange and recordkeeping provisions set forth in Sec.  1.908(a)(5) of
this final rule are appropriate because shippers, carriers, receivers,
and loaders operating under the control of a single legal entity can
effectively use common integrated written procedures that prescribe
sanitary food transportation practices. Accordingly, the provisions set
forth in Sec.  1.908(a)(5) of this rule will not be strictly limited to
vertically integrated companies, like the Bioterrorism Act's
recordkeeping rule.
    (Comment 22) One comment asks us to exempt from this final rule's
information exchange and recordkeeping requirements food transportation
operations that involve shipments of food from centralized charitable
food distribution centers that act as shippers, and sometimes also
carriers, to member food banks that are separate legal entities, but
are closely affiliated with the shippers. The comment also asks us to
exempt shipments between food banks. This comment asserts that these
types of operations are similar to intra-corporate food transportation
operations and, therefore, adherence to this rule's information
exchange and recordkeeping requirements should not be required because
internal written SOPs are sufficient for ensuring the sanitary
transportation of food between these types of entities.

    (Response 22) We decline to exempt food transportation operations
that involve shipments from centralized charitable food distribution
centers to food banks, as well, as food shipments between food banks,
from this rule's information exchange and recordkeeping requirements.
The commenter describes itself as being a national, domestic hunger
relief charity that acts as a shipper to distribute food to and through
a network of 200 member community food banks. The comment also states
that the individual food banks that form the network ``are separate
legal entities,'' but are ``closely affiliated with the national
organization.'' We decline to exempt these types of transportation
operations from this rule because we do not believe that they are
comparable to intra-corporate food transportation operations in which
shippers, loaders, carriers, and/or receivers operate under the
ownership or operational control of a single corporate/legal entity.
The commenter and its network of independent food banks are
``affiliated'' only in the sense that they cooperate closely to advance
their shared mission of delivering food assistance to people in need.
    However, we have made revisions in this final rule that may lessen
the information sharing and corresponding records requirements for
organizations such as the ones described by this comment. As we note in
our response to Comment 124, we have revised the information sharing
provisions in Sec.  1.908(b)(1) to only require one-time notification
to the carrier and when necessary, to the loader, by the shipper,
unless the design requirements and cleaning procedures required for
sanitary transport change because of the type of food being
transported. In addition, as we note in our response to Comment 129 and
Comment 134, we have revised Sec.  1.908(b)(2) to recognize that the
specification of pre-cooling and operating temperature parameters by
the shipper to the carrier, and to the loader, may not be necessary for
transportation operations conducted during winter in cold areas or for
short distance transportation of food in appropriate circumstances.
5. Lists of Nonfood Cargo That May Adulterate Food
    We requested comments in the preamble to the proposed rule in
response to our tentative decision not to identify and include, in this
rulemaking, specific nonfood products that, under all circumstances,
may adulterate food subsequently hauled in bulk or non-bulk vehicles.
We also requested comment on our tentative conclusion that issuing
guidance instead, regarding how some transportation practices may
affect the potential for nonfood products to adulterate food products,
and would be helpful to the transportation industry.
    (Comment 23) Many comments support our decision not to issue lists
of nonfood items that may adulterate food if transported simultaneously
with food in a non-bulk vehicle, or prior to the transport of food in a
bulk vehicle. Several comments agree with our tentative conclusion that
issuing guidance regarding how specific transportation practices may
affect the potential for nonfood products to adulterate food products
would be helpful to the transportation industry. One comment states
that the oilseed industry already uses lists of acceptable and
unacceptable previous cargos to prevent the adulteration of edible oils
during transport and encourages us to incorporate these lists as
reference documents in this rulemaking or to establish corresponding
guidance documents.
    (Response 23) Based upon these comments, we affirm our decision not
to include lists of nonfood items that may adulterate food if
transported simultaneously with food in a non-bulk vehicle, or prior to
the transport of food in a bulk vehicle, as part of this rulemaking.
However, we will consider the utility of using such lists as references
in any guidance we may issue on this subject in the future.
6. Need for Guidance
    (Comment 24) Several comments express the need for guidance
documents related to this rule. These comments state that guidance will
be important for explaining our expectations (e.g., what measures are
``effective'' or ``adequate''). Some comments state that, we should
provide specific guidance for foreign individuals and entities to
clarify who would be responsible for complying with the rule in complex
transportation operations involving international shipments into the
United States. In addition, a comment states that specific quantitative
requirements should be included in guidance rather than in this rule to
avoid implementation difficulties.
    (Response 24) We agree that guidance are important for helping
stakeholders to understand the application of this rule to their
operations. As we note elsewhere in this document, we may issue future
guidance, as resources allow, regarding issues such as the granting of
waivers, transportation activities performed by farms, and how
transportation practices may affect the potential for the adulteration
of food products by nonfood products during transportation operations.
We will consider whether guidance on these or other matters would be
useful to clarify measures that entities engaged in the transportation
of food may take to comply with this rule. We would not include
requirements in any guidance because under our good guidance practices
regulation (21 CFR 10.115), guidance documents do not establish legally
enforceable rights or responsibilities.
    (Comment 25) A comment addressing the transportation of RACs by
farms agrees with our tentative conclusion in the proposed rule that
the sanitary transportation practices that would be required by this
rule are not necessary to prevent RACs from becoming adulterated during
transportation by farms. However, to minimize the potential for
adulteration, this commenter recommends that we develop a guidance
document on good transportation practices, as well as user-friendly
education materials. The comment suggests that such guidance should
stress the importance of cleanout procedures in non-dedicated farm
transportation conveyances and equipment used to haul RACs and other
products, and provide sample clean-out procedures for such conveyances.
The comment also suggests that the guidance could encourage farms that
transport RACs to inform receivers about the previous load hauled in
the conveyance.
    (Response 25) We discussed the exemption of transportation
activities for RACs performed by farms from this rule in the proposed
rule (79 FR 7006 at 7016) and noted that the diversity of farms and
their transportation operations pose challenges in developing mandatory
requirements via rulemaking that would be broadly suitable and
meaningful for this sector of the food transportation industry. As we
discuss in Comment 79, we have revised this final rule to provide that
all transportation activities performed by a farm are not subject to
this rule. However, we agree that issuing a guidance document on farm
transportation operations may be useful in setting forth good
transportation practices, given the diverse practices that occur within
this sector. We, therefore, intend to consider establishing such
guidance and will consider the role that we might be able to play in
promoting educational and training activities to address this issue.

7. Preemption
    (Comment 26) Some comments expressed concern with the preemption
provision of the 2005 SFTA and its potential impact on any State with
existing transportation requirements. One comment stated that this rule
should be flexible enough to permit State laws to stay in effect if the
State law is stronger and its enforcement is superior to what is being
achieved under this rule. Some of these comments asserted that the
statutory exclusions in the coverage of the 2005 SFTA, e.g., its non-
coverage of barge transport, in combination with the preemption
provision could weaken existing State activities and regulation of
industry and prevent States from developing a unified sanitary
transportation regulation.
    (Response 26) As we stated in the proposed rule (79 FR 7006 at
7032), the 2005 SFTA includes an express preemption provision at
section 416(e) of the FD&C Act, which provides that a requirement of a
State or political subdivision of a State that concerns the
transportation of food is preempted if: (1) Complying with the
requirement of the State or political subdivision and with a
requirement of section 416, or with a regulation issued under section
416, is not possible; or (2) the requirement of the State or political
subdivision as applied or enforced is an obstacle to accomplishing and
carrying out section 416 or a regulation issued under section 416.
Section 416(e) of the FD&C Act further provides that the express
preemption provision applies to transportation that occurs on or after
the effective date of regulations issued under section 416. This
express preemption provision applies to the requirements of this final
rule upon their becoming effective. Nonetheless, a State law, including
unified State laws, should States wish to adopt such laws, concerning
the sanitary transportation of food by motor vehicle or rail vehicle,
is not preempted if such laws do not fall under either section
416(e)(1) or (2) of the FD&C Act. Furthermore, it is highly unlikely
that any State law addressing transportation operations not subject to
the 2005 SFTA, e.g., barge transport, would fall within the scope of
the 2005 SFTA's preemption provision. In most cases, a more stringent
provision in State law would not be preempted.
    (Comment 27) Some comments urge us to affirm that this rule does
not preempt related State laws when they are ``in addition to'' Federal
regulation and do not present an obstacle to advancing the purposes of
SFTA. The comments further state that we should construe the preemption
clause in the SFTA of 2005 narrowly and that we should work in tandem
with State authorities by treating this regulation as a floor, and not
a ceiling, for State public health measures such that States wishing to
enact sanitary food transportation requirements that are more rigorous
than those imposed by this rule will be permitted to do so. These
comments state that there are two ways that a Federal authority can
block State regulation--either by ``conflict (or obstacle) preemption''
or by ``field preemption''--and the comment stated that the language in
the SFTA is an example of the former. Conflict preemption only applies
when a person or entity cannot satisfy both Federal and State law, and
where State law is an obstacle to Federal goals.
    (Response 27) Under section 416(e) of the FD&C Act, this rule does
not preempt State laws or laws of a political subdivision regarding
sanitary transportation of human and animal food unless complying with
those laws and this law is impossible, or the requirement of the State
or political subdivision as applied or enforced is an obstacle to
carrying out this law. Section 416(e) of the FD&C Act further provides
that the express preemption provision applies to transportation that
occurs on or after the effective date of regulations issued under
section 416.
    We agree with the commenters that conflict preemption could apply
to any State laws governing sanitary food transportation that would
make it impossible to simultaneously comply with this rule. In
addition, another aspect of conflict preemption could apply under a
``frustration of purpose'' or ``obstacle'' theory, whereby a State law
requiring sanitary transportation practices would be preempted to the
extent the State law frustrates the purpose of, or presents an obstacle
to accomplishing the purpose of, this rule. Whether a State requirement
is preempted by Federal law depends on specific factual situations.
Therefore, although some State requirements may be preempted by Federal
law, this law does not prevent States from developing sanitary
transportation regulations at the State or local level.
8. Issuance of Sanitary Transportation Supplemental Proposed Rule
    (Comment 28) Some comments ask us to publish a revised proposed
rule or an interim rule before proceeding to a final rule because of
anticipated, significant changes resulting from comments that we
received in response to the proposed rule, as well as potentially
significant changes in the other, interrelated FSMA rules. One comment
states that because the FSMA rules are dependent on one another, all
proposed FSMA rules should be issued concurrently so that a concurrent
evaluation and comment period may be conducted. Some comments state
that re-proposal and a second opportunity for public comment also is
warranted because implementation of the sanitary transportation rule
will require the complex coordination of efforts among multiple Federal
Agencies.
    (Response 28) We considered these comments requesting that we issue
a supplemental proposal. This final rule includes numerous revisions to
the proposed rule. These revisions, however, better achieve our stated
objective in the proposed rule to align the provisions of this rule
with current safe food transportation practices and to allow industry
to continue to use existing practices that have proven to be effective.
The revisions we made to this rule are also a logical outgrowth from
the proposed rule and are supported by comments that we received in
response to the proposed rule. Therefore, we have determined that
issuing a supplemental proposal of the rule is not necessary.
    We also do not believe that we need to issue a supplemental
proposal because implementation will require complex coordination among
multiple Federal Agencies. We have sufficiently addressed in our
responses to Comment 12 and Comment 13 the application of this rule to
food that is subject to the regulatory authority of USDA. In addition,
while section 5701 of the 2005 SFTA directs DOT to establish procedures
for transportation safety inspections for the purpose of identifying
suspected incidents of contamination or adulteration of food during
transport in violation of this rule, we do not consider any
coordination that we must do with DOT on enforcement to be particularly
complex, such that it would have benefited from an additional
opportunity for public comment. Therefore, we have determined that
issuing a supplemental proposal to consider further aspects of this
rule that are relevant to our interactions and relationships with other
Federal Agencies is not necessary.
    With regard to the suggestion that we should re-issue all seven of
the FSMA foundational proposed rules simultaneously for comment, we
agree that this might have been helpful to commenters. However, given
our deadlines under a consent decree for the seven rules (Ref. 21),
this was not possible. We also believe that stakeholders were given
adequate opportunity to comment on the

proposed rules, particularly those that are interrelated and were
issued simultaneously as supplemental proposed rules in September 2014.
9. Retrospective Review
    (Comment 29) One comment states that in line with the requirements
of Executive Order 13563, the Office of Management and Budget's (OMB's)
implementation memo for that Executive order (Ref. 22), and OMB's 2013
Report to Congress (Ref. 23), it is clear that FDA should incorporate
specific plans for retrospective review and ex post evaluation into the
text of its final rule. The comment also suggests that given the
uncertainty of the underlying data used to formulate the provisions of
this rule, we commit to measuring the actual effects of the regulation
and use the data we collect during the implementation of the rule to
annually review whether the standards are having their desired effects.
    (Response 29) We disagree. As discussed in the Final Regulatory
Impact Analysis for this rule (Ref. 24), we have examined the impacts
of the proposed rule under Executive Orders 13563 and 12866, in
relevant part. Section 6 of Executive Order 13563 addresses
retrospective analysis of existing rules by agencies, but the Executive
order does not require that agencies include retrospective review plans
in the codified text. FDA is committed to reviewing its rules to ensure
their implementation is effective.
10. Transportation by Modes Other Than Motor Vehicle and Rail Vehicle
    (Comment 30) One comment expresses concern about gaps in FDA's
authority to regulate different types of food transport conveyances
under the 2005 SFTA. The comment notes that the statute specifically
limits our regulatory authority to the transportation of food by motor
carriers and rail vehicles, excluding transportation by barge or ship
and by air. The comment asserts that these omissions create critical
weaknesses in the sanitary food transportation system because
significant amounts of animal feed grain are transported by barge or
ship within the United States and because highly perishable food
products are frequently transported by aircraft. Another comment
recommends that we explicitly state in this rulemaking that these
additional conveyances are excluded and provide a rationale for their
exclusion.
    (Response 30) The 2005 SFTA, as passed by Congress and signed into
law by the President of the United States, expressly mandates that FDA
issue regulations to ``require shippers, carriers by motor vehicle or
rail vehicle, receivers, and other persons engaged in the
transportation of food to use sanitary transportation practices . . .
to ensure that food is not transported under conditions that may render
the food adulterated'' (21 U.S.C. 350e(b)). We do not believe that we
need to issue any confirmatory statements or rationales in response to
these comments because the relevant 2005 SFTA statutory language is
plain and clear on its face. The 2005 SFTA does not mandate that we
issue regulations applicable to the sanitary transportation of food by
any other conveyances, including barges or ships and aircraft. However,
if we find that there is a public health need for us to regulate air
and barge or ship transportation, we will consider whether we want to
pursue covering these routes under a non-SFTA authority in the future.
11. Waivers
    We stated in the proposed rule (79 FR 7006 at 7029-7030) that we
had tentatively determined that it would be appropriate to waive the
applicable requirements of this rule, if finalized as proposed, with
respect to the following classes of persons:
     Shippers, carriers, and receivers who hold valid permits
and are inspected under the National Conference on Interstate Milk
Shipments (NCIMS) Grade ``A'' Milk Safety Program, only when engaged in
transportation operations involving Grade A milk and milk products; and
     Food establishments, i.e., retail and food service
operations, holding valid permits, only when engaged in transportation
operations as receivers, or as shippers and carriers in operations in
which food is relinquished to consumers after transportation from the
establishment.
    We stated our intent to separately publish in the Federal Register,
at the time of publication of this final rule, waivers and the reasons
for the waivers for these two classes of persons from the applicable
requirements of this rule. We requested comment regarding whether these
proposed waivers could result in the transportation of food under
conditions that would be unsafe for human or animal health, or could be
contrary to the public interest. We did not receive any such comments.
    However, we did receive comments requesting that we modify or
expand the scope of these waivers beyond that which we discussed in the
proposed rule. While we intend to publish waivers in the Federal
Register addressing the aforementioned classes of persons prior to the
compliance date of this final rule, we are evaluating these comments to
determine whether we should modify either of these two waivers as
requested, and we intend to post a notice on our Web site of our
reasoning regarding the scope of these prospective waivers at the
soonest possible date. We will also discuss, in this subsequent notice,
our thinking on comments we received asking us to consider publishing
an additional waiver for transportation operations for molluscan
shellfish for entities that hold valid State permits under the National
Shellfish Sanitation Program.
    (Comment 31) We received comments that we should acknowledge Tribal
food codes in addition to state and local food codes in our discussion
of waivers and that we should refer to Tribal governments in this final
rule in every instance in which we mention State or foreign
governments.
    (Response 31) We acknowledge that tribal authorities, as well as
state and local government agencies, can issue permits to food
establishments under their relevant regulatory authority. In light of
comments, throughout this final rule we explicitly recognize Tribal
governments as partners we intend to work with in the implementation of
this rule,e.g., as regulatory authorities we may partner with in future
efforts to train regulators (see Comment 6, Comment 19, Comment 159,
and Comment 176).

IV. What comments did we receive on the specific provisions of the
proposed rule?

A. Who is subject to this subpart? (Sec.  1.900)

    In table 5 we outline the revisions we have made to Sec.  1.900 in
finalizing this rulemaking. Following the table we respond to comments
about these provisions.

                              Table 5--Sec.   1.900 Who is Subject to This Subpart?
----------------------------------------------------------------------------------------------------------------
         Proposed section (Sec.   )                      Description                        Revision
----------------------------------------------------------------------------------------------------------------
1.900(a)....................................  Specifies that, except for        Added ``loaders'' to the list of
                                               certain exclusions and            covered entities.
                                               exceptions, this rule applies
                                               to shipper, loaders, carriers,
                                               and receivers engaged in
                                               transportation operations.
1.900(b)(1).................................  Specifies that the provisions do  No revisions.
                                               not apply to food that is
                                               transshipped through the United
                                               States to another country.
1.900(b)(2).................................  Specifies that the provisions do  Added ``in accordance with
                                               not apply to food that is         section 801(d)(3) of the FD&C
                                               imported for export in            Act'' to the regulatory text
                                               accordance with 801(d)(3) and     for clarity.
                                               that is neither consumed or
                                               distributed in the United
                                               States.
1.900(b)(3).................................  Specifies that the provisions do  New provision.
                                               not apply to food in facilities
                                               regulated exclusively,
                                               throughout the entire facility,
                                               by USDA.
----------------------------------------------------------------------------------------------------------------

    (Comment 32) One comment expresses concern about whether the
responsibilities that apply to persons subject to this rule would apply
to a specific, individual person rather than to an entity. The comment
notes that we indicated in the proposed rule that the intent of the
rule is to establish accountability at the individual level for
ensuring that transportation operations comply with the rule's
requirements. However, the commenter asserts that it is not appropriate
to place all responsibility onto a single individual. The comment
supports having a qualified individual supervise and provide general
oversight, but requests confirmation that the term ``person'' used in
this rule refers to legal persons--including corporations.
    (Response 32) The statement that this comment references from the
proposed rule (79 FR 7006 at 7018) addresses the proposed requirement
in Sec.  1.908(a)(2) that responsibility for ensuring that
transportation operations are carried out in compliance with all
requirements of this rule must be assigned to competent supervisory
personnel. That specific requirement does designate an individual as
being responsible for this requirement, but we did not state that the
intent of the rule is to establish accountability at the individual
level for compliance with all requirements of the rule. The term
``person'' as used in this rule will include ``individuals,
partnerships, corporations, and associations.''
    (Comment 33) One comment asked us to affirm that, for cheese
exported to the United States under ``freight on board'' (FOB)
contracts, the shipper is not responsible under this rule once the
goods are delivered to a warehouse in the United States. FOB contracts
specify that, once the goods have been turned over to the transporting
company, the purchaser assumes the risk of loss as defined by the
Agreement on International Commercial Terms.
    (Response 33) The responsibilities of a shipper under this rule are
not affected by the type of shipping arrangement, e.g., an FOB
contract, and nothing in this rule specifies which party assumes the
risk of loss.
    (Comment 34) One comment asked whether the term ``other persons''
engaged in transportation might include governmental customs agencies
that might withhold or load products during the agencies' custom
processing operations for more time than considered to be usual in
transport to their final destination. The commenter expresses concern
that such a delay might potentially create food safety issues.
    (Response 34) The 2005 SFTA authorizes us by regulation to require
shippers, carriers by motor vehicle or rail vehicle, receivers, and
other persons engaged in the transportation of food to use sanitary
transportation practices to ensure that food is not transported under
conditions that may render the food adulterated. Generally,
governmental customs officials are not engaged in food transportation
operations and typically would not be subject to this rulemaking. Their
role in inspecting food does not bring them within the scope of what
this rule is intended to cover.
    (Comment 35) A few comments asked us to address responsibility
under this rule in a few situations involving international shipments
into the United States. One comment, for example, asked if a rail bulk
container travels from Canada to a U.S. rail yard and then is
transferred to a new train, is the person or entity that initiated the
shipment in Canada the shipper, or is the shipper the person that
transferred the bulk container at the U.S. rail yard for further
transport in the United States? Another comment asks us to identify the
carrier for a closed container that is shipped into the United States
by ocean-going vessel and then is transferred, unopened, at the U.S.
port of entry onto a truck. Finally, one comment asks us who would be
held responsible under this rule if a refrigerated container is shipped
from China to the United States via ocean-going vessel and then is
transferred, unopened, at the U.S. port of entry onto a truck, and upon
receipt, the U.S. receiver discovers evidence of temperature abuse.
    (Response 35) In the first example, the shipper for any segment of
transportation of the bulk container, e.g., the Canada to U.S. rail
segment and also the rail segment originating in the United States, is
the person who arranges for that segment of the transportation of the
food by a carrier. The shipper may be the same person throughout the
transit of the container if a single person arranges for all segments
of its transport. In the second instance, the carrier is the person who
physically moves the food from the point it becomes subject to this
rule, i.e., at the origination of the truck segment in the United
States. With respect to the third example, the matter of (legal)
responsibility will depend on whether it can be established which
actor(s) (i.e., the shipper, loader, and/or carrier) failed to comply
with the applicable requirements of Sec.  1.908, and whether this non-
compliance contributed to the food becoming unsafe as a result of the
failure to provide temperature control. At any rate, whenever it is
discovered that the food may have experienced a material failure of
temperature control or other conditions that could render the food
unsafe, the provision in Sec.  1.908(a)(6) applies and the food shall
not be sold or otherwise distributed until it is determined that the
temperature deviation or other condition did not render the food
unsafe, which may involve communication among the persons subject to
this rule. The responsibilities

of persons subject to this rule are discussed in our response to
Comment 129.
    (Comment 36) One comment asks us to consider situations that
include several different transportation legs in determining how
parties are defined, or whether specific responsibilities assigned on
the basis of the roles the persons involved in transportation
operations play are even necessary. For example, corn grain is
harvested and (1) taken in a semi-trailer by a farmer to the grain
elevator, where it is (2) loaded in a rail car and transported to the
Mississippi River, and (3) loaded in a barge for additional transport.
Upon arrival, the grain is offloaded into a railcar and is then sent to
a feed mill for mixing into hog feed. The comment seeks clarification
on the applicability of the regulation if not all parties are subject
to this rule, e.g., the parties are performing a non-covered activity
(e.g., transport by barge or airplane) or are exempt by size.
    (Response 36) In this example, the initial transportation operation
would not be subject to this rule because it involves the
transportation of food by a farm. In the example described in this
comment, the grain elevator would be the receiver. The second segment
of transit is subject to this rule because the transportation operation
is by rail vehicle and the shipper, loader, carrier and receiver would
be the persons who meet the definitions of these entities in this rule.
These may not be separate persons, i.e., the shipper and the loader may
be the same person. The third segment of transit is not subject to this
rule because it involves transportation by a river barge. The fourth
segment of transit is subject to this rule in the same manner as the
second segment.
    We acknowledge that situations may occur where not all parties
involved in a transportation operation are subject to this rule, e.g.,
the shipper is a non-covered business, but the carrier is subject to
this rule. In these situations, interactive requirements among covered
entities established by this rule, e.g., communication between shippers
and carriers, would not be operative and the dialogue between the
covered entities that will ensure that safe food transport requirements
are understood and entities play their respective roles will not
necessarily happen. This situation will disadvantage the entities that
are covered businesses, especially if the shipper is not a covered
entity. In situations where the shipper (or any entity) is not covered,
we believe that the relevant information to ensure safe transport of
food (such as appropriate temperatures for refrigeration for foods that
require temperature control for safety) will be available in some form
to those entities that are covered, though it may not be provided via
written records which we consider ideal. Even if certain entities are
not covered by this rule, all parties are subject to the general food
safety requirements of the FD&C Act.
    (Comment 37) A comment expressed concern with the shipper
requirements because shipments originating abroad and destined for
interior locations in the United States are arranged in the country of
origin and the shippers in under-developed countries are not always
accessible or easy to connect with, and may not be equipped to
communicate with foreign companies and governments. There would be no
U.S. shipper in this circumstance and it is unclear how the U.S.
carrier and receiver would comply with reporting requirements related
to the shipper.
    (Response 37) International shipments such as those described in
this comment can present difficulties for U.S. firms subject to this
rule when it may be necessary to investigate the history of a shipment
because, in addition to the circumstances described by the comment, a
segment of the shipment, i.e., ocean transport, is not subject to this
rule. In circumstances where it would normally be necessary for a U.S.
receiver or carrier to contact the foreign shipper under the
requirements of this rule (e.g., if a question arose concerning
temperature control during shipment) if the shipper is not readily
accessible for any reason, the carrier or receiver would have the
responsibility under Sec.  1.908(a)(6), which we discuss in Comment
129. We have added this provision to this final rule to ensure that any
question relevant to whether the food may be adulterated is adequately
addressed before the shipment is allowed to proceed in U.S. commerce.
It is unlawful under section 301(a) of the FD&C Act (21 U.S.C. 331(a))
to introduce or deliver for introduction into interstate commerce any
food that is adulterated. Further, even in cases where there is a
foreign shipper, that shipper may be working in conjunction with a U.S.
freight broker that could be contacted in its place to evaluate whether
the food is unsafe. Moreover, if the freight broker has arranged the
U.S. land-based transportation leg of the foreign shipment, the broker
is the legally responsible ``shipper'' for purposes of the rule and
therefore subject to the applicable requirements of Sec.  1.908,
including the requirement to specify to the carrier the conditions
necessary to ensure the safe transport of the food. We also refer
readers to our response to Comment 9.
    (Comment 38) One comment states that this rule should also apply to
entities that transfer a product from one mode of transportation to
another (trans-loaders). It is common, particularly for feed
ingredients, to have the cargo trans-loaded from a railcar to a truck.
The comment recommends that FDA clarify the situations in which trans-
loaders are to be considered shippers, carriers, or receivers because a
trans-loader may be a separate (sub-contracted) entity.
    (Response 38) An entity that only transfers food cargo from one
mode of transportation to another, e.g., from a railcar to a truck,
would be subject to this rule as a receiver of food arriving by rail
vehicle and as a loader of food onto trucks. The entity would not be
considered to be a shipper if it simply holds the food pending truck
transport and does not arrange for its transport by the trucking firm.
The entity may also be subject to other FDA requirements that address
the operation of its facility, e.g., the preventive controls rules for
human or animal food.
    (Comment 39) One comment asks who acts as the shipper when a single
container is shipped using multiple modes of transportation. A
container, for example, may start its transit on a truck and then be
transferred to a rail car and remain sealed until it reaches its final
destination. The comment states that in such instances, the entity that
initiated the shipment initially should be considered the ``shipper''
throughout the voyage and not an entity that transfers the container
between conveyances. The comment states that if the second entity were
considered to be the shipper, it might have to open the container to
inspect it for cleanliness before the container continues in transit,
which could impact the safety of the shipment because this would mean
breaking the container's seal.
    (Response 39) Under this rule, the shipper is the person who
arranges for the transportation of food by the carrier. If, in the
example given in this comment, a single person arranges for the
shipment of the food via multiple modes of transportation, that person
is the shipper throughout all stages of transport. The commenter's
interpretation, that if another person becomes a subsequent shipper of
a sealed container, that person would have to open the container and
inspect it before shipment, is incorrect. Nothing in this rule would
require the second shipper to open and inspect the sealed container.
1.900(b)
    We are adding text for clarity to Sec.  1.900(b)(2) to specify that
``food that is

imported for future export'' specifically refers to articles of food
that are subject to the provisions of section 801(d)(3) of the FD&C Act
(21 U.S.C. 381(d)(3)). The added text gives definitive clarity to
inform regulated entities that, when we refer to ``food'' that lawfully
can be ``imported for export,'' ``food'' means ``a food additive, color
additive, or dietary supplement'' as specified by section 801(d)(3) of
the FD&C Act.