Sanitary Transportation of Human and Animal Food, 20091-20170 [2016-07330]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Rules and Regulations]
[Pages 20091-20170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07330]



[[Page 20091]]

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, 240-402-2022.

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.

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    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

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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

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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

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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

[[Page 20097]]

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

[[Page 20098]]

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

[[Page 20099]]

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

[[Page 20100]]

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

[[Page 20101]]

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

[[Page 20102]]

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: https://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.

[[Page 20103]]

    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.

[[Page 20104]]

    (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.

[[Page 20105]]

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

[[Page 20106]]

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.

[[Page 20107]]



                              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

[[Page 20108]]

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

[[Page 20109]]

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.
    (Comment 40) We received a comment asking us to clarify what 
actions food transporters must take to assure compliance when their 
food product is intended exclusively for export markets. Another 
comment states that many commodities intended for export are shipped in 
standard ocean containers (known in the industry as forty-foot 
equivalent units (FEUs) and twenty-foot equivalent units (TEUs)), which 
are owned or leased by steamship lines. This means that the shipper, 
carrier, and receiver, as identified in the proposed rule, do not own 
the ocean-going container, which often travels on a truck or rail 
chassis before reaching a U.S. port for export. The comment asserts 
that this complicates the relationships and documentation required in 
the proposed rule between the shipper and the container holder for 
exports.
    (Response 40) The 2005 SFTA states that we must, by regulation, 
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. Further, the statute defines ``transportation'' as any 
movement in commerce by motor vehicle or rail vehicle. Thus, persons 
engaged in the transportation of food that is intended for export are 
subject to all applicable requirements of this rule when the food is in 
transit by motor vehicle or rail vehicle to the land-based U.S. border 
point of export or a port facility. For example, the loader for a truck 
transportation segment moving the food to a vessel port facility is 
subject to the rule because it is loading a motor vehicle. The loader 
for the trans-oceanic ship transport segment is not subject to the rule 
because the rule does not cover transportation operations for water 
borne transportation. However, the operations of the second loader are 
still subject to section 402(a)(4) of the FD&C Act, which prohibits the 
holding of food under insanitary conditions whereby it may be rendered 
injurious to health or may become contaminated with filth.
    We recognize that under typical practices in the industry, ocean 
containers are likely to be inspected and otherwise prepared for 
transportation by the person who loads the container, e.g., the shipper 
or loader, not by the owner or supplier of the container. As we discuss 
in our response to Comment 53, this rule does not place any 
requirements upon the owner or supplier of the container whether 
foreign or domestic, in circumstances where they are not a shipper, 
loader, or carrier, and thus we do not anticipate that there will be 
relational or documentation issues for shippers to address with such 
equipment owners as a result of this rule.
    (Comment 41) Another comment asks us to include an exemption for 
human and animal food originating in the United States but bound for 
export from the requirements of this rule. The comment notes that the 
proposed rule would not apply to transportation operations for food 
that is imported but is not ``consumed or distributed'' in the United 
States because it is exclusively destined for subsequent export. The 
comment states that food that originates in the United States and is 
bound for export travels by vehicle or rail car to reach U.S. ports of 
exit and, like food that is transshipped through the United States to 
another country or food that is imported for export, it is neither 
consumed nor distributed until it reaches foreign soil. The comment 
therefore recommends that we exempt food that originates in the United 
States, but that is bound for export, from this rule by including under 
Sec.  1.900(b) the provision: ``Human and animal food that moves under 
Customs and Border Protection (CBP) export reporting procedures 
including Automated Export System (AES) and is therefore neither 
consumed nor distributed in the United States.'' The comment asserts 
that requiring that the shipments of the food comply with CBP export 
reporting and documentation procedures ensures that cargo bound for 
export will not be diverted into the U.S. food supply for domestic 
consumption.
    (Response 41) We decline to exempt persons engaged in the 
transportation of human and animal food originating in the United 
States and bound for export from the requirements of this rule, because 
food that originates in the United States and is bound for export is 
handled in a fundamentally different manner than food that is 
transshipped through the United States to another country, for example 
from Mexico for delivery to Canada, or food that is imported for future 
export in accordance with section 801(d)(3) of the FD&C Act, and that 
is neither consumed nor distributed in the United States. In the cases 
of import for export and transshipment, legally enforceable mechanisms 
exist that ensure that the food will not be diverted for consumption or 
distribution in the United States.
    With respect to food that is transshipped through the United States 
to another country, CBP regulations in 19 CFR 18.10, ``Kinds of 
Entry,'' list the various entries and withdrawals that may be made for 
merchandise transported in bond. One kind of entry is the 
transportation and exportation (T&E) entry. A party that transships 
merchandise in bond through the United States must submit T&E 
documentation with the CBP and the CBP supervises the shipment of the 
merchandise through the United States, as well as the intact export of 
the goods to foreign destinations.
    Similarly, under section 801(d)(3) of the FD&C Act, parties which 
import certain articles that are intended exclusively for further 
processing or incorporation into another product and for subsequent, 
mandatory export because the articles cannot be distributed or used in 
the United States must provide FDA with certain information at the time 
of initial importation. These articles include food subject to this 
rule, specifically, food additives, color additives and dietary 
supplements. These parties must provide, among other things, a 
statement that confirms their intent to further process such articles 
or incorporate such articles into a product for purposes of subsequent 
export, and must provide us with the identities of the entities in the 
chain of possession of the imported articles while the articles are in 
the United States. Importers also must provide us with certificates of 
analysis, as necessary, to identify the article of food. In addition, 
at the time of initial importation and before delivery to the importer, 
initial owner, or consignee, a bond must be executed providing for 
liquidated damages in the event of default, in accordance with CBP 
requirements. The initial owner or consignee of the article also must 
maintain records of the use and/or destruction of such imports and must 
submit the records or a report to FDA upon request. The initial owner 
or consignee also must destroy any article or portion thereof that is 
not used in an exported product.
    The AES system, on the other hand, collects Electronic Export 
Information (EEI), formerly known as Shipper's Export Declaration (or 
any successor document) from persons exporting

[[Page 20110]]

goods from the United States, Puerto Rico, or the U.S. Virgin Islands; 
between Puerto Rico and the United States; and to the U.S. Virgin 
Islands from the United States or Puerto Rico. AES is the central point 
through which export shipment data required by multiple Federal 
Agencies is filed electronically with CBP and is operational at all 
ports and for all methods of transportation. It was designed to assure 
compliance with and enforcement of various export laws, improve trade 
statistics, reduce duplicate reporting to multiple agencies, and 
improve customer service.
    However, AES is not specifically designed to function as a legally 
enforceable mechanism to ensure that food bound for export is not 
diverted into the domestic supply chain and consumed in the United 
States. The AES system does not become operative until food arrives at 
a point of export. Therefore, if a shipper states that any given food 
shipment that originates in the United States is destined for export 
and transports the food without complying with the requirements of this 
rule, but subsequently decides to divert the food for purposes of 
domestic consumption or distribution, neither we nor the CBP would have 
any way of knowing that the food had been diverted for domestic 
consumption, perhaps after being transported under insanitary 
conditions. In addition, unlike food transshipped through the United 
States and food imported exclusively for subsequent export, food that 
originates in the United States and is intended for export, whether it 
is diverted for domestic consumption or is actually exported, is not 
transported under a bond. Accordingly, we do not agree that a basis 
comparable to that for food transshipped through the U.S., or food 
imported for export, exists for exempting persons engaged in the 
transportation of human and animal food that originates in the United 
States but is bound for export from the requirements of this rule as 
suggested by this comment.
    (Comment 42) One comment states that, when cargo is deemed to be 
adulterated, one of the primary salvage markets may be destinations 
outside of the United States. The comment observes that this rule 
appears not to apply to food outside of the United States and argues 
that, if that is the case, we should clarify that it should not apply 
to food that is shipped outside of the United States to a destination 
that was not the original, intended primary market.
    (Response 42) If the product has already been offered for sale in 
the United States and is found to be adulterated, it cannot be legally 
exported for sale in markets outside the United States. (See United 
States v. Kanasco, Ltd., 123 F.3d 209 (4th Cir. 1997) (although this 
case involved drug products and not food, it stands for the principle 
that, if product is adulterated, it cannot be legally offered for sale 
outside the United States).) The owner of the product can pursue other 
lawful options, such as reconditioning the product or diverting the 
product to nonfood uses. If, however, the food has not been offered for 
sale in the United States and otherwise meets the requirements of 
section 801(e)(1) of the FD&C Act, it can be shipped abroad and would 
not be subject to the adulterated food provisions of the FD&C Act and 
therefore would not be subject to this rule.
    (Comment 43) A comment requests that we address the safe disposal 
of contaminated foods from a rejected delivery and the sanitization of 
trailers carrying such cargo. The comment states that when a delivery 
is rejected, the responsibility for and costs associated with safely 
disposing of the shipment is often placed on truckers, in some cases 
with little or no instructions from the shipper. Consequently, 
according to the comment, drivers who need to dispose of contaminated 
cargo sometimes simply dump it, give it away to the public, or sell it. 
The comment states that FDA should explore, in this or a separate 
rulemaking, the development of rules governing such rejections. The 
comment further suggests that we should address when rule violations 
can serve as the basis for the rejection of a delivery and/or a cargo 
insurance claim, acceptable methods of disposing of contaminated food 
products after rejection, and the apportionment of disposal costs among 
parties involved in the transportation of rejected cargoes.
    (Response 43) This rule addresses the sanitary transportation of 
human and animal food to prevent practices that may create food safety 
risks. We recognize the burdens and uncertainties that may arise when a 
load is rejected. However, the basis on which a load may be rejected, 
and the disposition of and costs associated with the disposal of 
rejected loads of food, are beyond the scope of this rule. We do not 
agree that we should explore the development of rules to govern 
rejections and/or cargo insurance claims, or rejected product disposal 
issues, because they often involve purely economic considerations about 
food shipments, which do not fall within our jurisdiction. Also, issues 
of liability are similarly subject to Federal laws that we do not have 
the authority to administer. We note, however, that if a food shipment 
is rejected because it is adulterated, the person responsible for that 
food cannot distribute or offer it for sale. Further, the carrier of a 
rejected food shipment must ensure that the motor or rail vehicle used 
to transport the rejected load complies with the vehicle and equipment 
provisions of Sec.  1.906 before it is used again to transport food.

B. How do the criteria and definitions in this subpart apply under the 
Federal Food, Drug, and Cosmetic Act? (Sec.  1.902)

    The only change we made in the proposed provisions in Sec.  
1.902(a) and (b), which specify that the criteria and definitions in 
part 1, subpart O apply in determining whether food is adulterated 
within the meaning of section 402(i) of the FD&C Act and that failure 
to comply with the requirements of part 1, subpart O is a prohibited 
act, was to add ``loaders'' to the list of covered entities in both 
paragraphs.
    (Comment 44) One comment asks us to replace the term ``in 
compliance'' throughout the final rule with the term ``in 
conformance.''
    (Response 44) We decline this request. We have used the phrase ``in 
compliance'' in Sec.  1.902(a) of this rule consistent with the 
language of section 7202(a) of the 2005 SFTA, which amends the FD&C Act 
by adding section 416 to the FD&C Act to provide that a food shall be 
deemed to be adulterated ``[i]f it 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 regulations 
promulgated under section 416.''
    (Comment 45) Several comments express concern about food being 
considered adulterated under this rule simply because of the failure of 
a carrier to adhere to a shipper's specified conditions during 
transport, such as maintaining a specified temperature, regardless of 
whether the food is actually unsafe. In particular, these comments 
speak to concerns about the impact the rule, as proposed, would have on 
the cargo claims process governed by the ``Carmack Amendment'' found in 
49 U.S.C. 14706. Under this provision of Federal law, a shipper or 
receiver seeking to recover money for cargo loss or damage from a 
carrier must show that the cargo is actually lost or damaged. The mere 
possibility of damage through ``potential'' exposure is not sufficient 
to prove an actual loss. One comment states that this rule is 
problematic because it directly links failure to

[[Page 20111]]

adhere to shipper-specified conditions for transportation with 
adulteration of, or damage to, food products during transport. 
According to this comment, the operation of this rule would mean that a 
claimant would no longer be required to prove that a shipment of food 
is actually damaged, but rather would only be required to prove the 
shipment was not maintained in accordance with a shipper's specified 
condition. One comment also states that this rule should clearly state 
in Sec.  1.902 that ``Variance from the requirements of this rule does 
not create a per se presumption of adulteration, and that the 
provisions of the Carmack Amendment, 49 U.S.C. 14706, still apply in 
determining liability of the parties regarding loss or damage to 
cargo.''
    (Response 45) We decline to make the specific change requested, but 
we have made other revisions to this rule that address the commenter's 
concerns. We have revised the provisions of this rule, for example, 
that address instances in which a carrier might not meet a shipper's 
specifications for temperature control during transportation. An 
inconsequential failure by a carrier to meet the shipper's temperature 
control specifications will not necessarily create a per se presumption 
that the affected food has become adulterated. However, as we discuss 
in our response to Comment 129, under this rule, in Sec.  1.908(a)(6), 
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. Failure to take such action may render the food 
adulterated.
    We also have revised this rule in Sec. Sec.  1.906 and 1.908, as we 
discuss in our response to Comment 89, to clearly state that the 
requirements for transportation equipment and transportation operations 
are intended to prevent food from becoming unsafe during 
transportation. This revision, in addition to others, makes it clear 
that under this rule we will apply section 402 of the FD&C Act, as it 
addresses food safety, to determine whether food has become adulterated 
during transport. Persons engaged in transportation operations should 
not expect that we will apply a different standard or different 
criteria for evaluating compliance with this rule. Therefore, we do not 
anticipate that this rule will have a significant impact on the cargo 
claims process.
    (Comment 46) Some comments state that there are other common 
occurrences that they believe could unnecessarily result in a 
presumption of adulteration under the proposed rule. These commenters 
express concern that the proposed rule can be interpreted broadly 
enough to create potential issues if broken seals or evidence of 
tampering create a presumption of adulteration, absent any evidence of 
actual threats to the public health.
    (Response 46) We have made revisions to this rule that address the 
concerns of these comments. As we stated in our response to the 
previous comment, when assessing transportation equipment and 
transportation operations, we will apply the food safety provisions of 
section 402 of the FD&C Act as the standard for determining whether 
food has become adulterated during transport. Persons engaged in 
transportation operations should not expect that we will apply a 
different standard or different criteria for evaluating compliance with 
this rule. A broken cargo seal or any evidence of food cargo tampering 
would not necessarily create a per se presumption of adulteration. 
However, we advise persons engaged in transportation operations that, 
if such situations should arise, they should carefully evaluate the 
facts and circumstances of each incident, on a case-by-case basis, to 
determine whether the safety of the food cargo may have been 
compromised.
    (Comment 47) Some comments asked that we clarify, in certain 
particulars, the interpretation of ``conditions not in compliance'' in 
section 402(i) in the FD&C Act, the statutory adulteration provision 
added to the FD&C Act by the 2005 SFTA. Under that provision, a food is 
adulterated if it 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 regulations issued under section 416 of the FD&C Act, 
i.e., this final rule. Some of these comments expressed concern that 
the application of this provision would lead to food being deemed 
adulterated by regulatory authorities in the absence of physical 
conditions indicating a food safety risk. One comment stated that non-
compliance with the recordkeeping provisions of this final rule alone 
should not be a basis for deeming food to be adulterated, assuming the 
records and documentation of the firm do not indicate a systematic and 
continued failure of a firm to implement sanitary transportation 
practices. A comment also asked us to recognize that under this rule, 
an enforcement authority will retain the discretion to consider the 
specific circumstances in each situation, e.g., if there are only minor 
deviations from the requirements of this rule, in determining whether 
food is adulterated.
    (Response 47) Under section 402(i) of the FD&C Act, ``a food shall 
be deemed adulterated if it 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 regulations promulgated under section 
416.'' Section 416(b) of the FD&C Act mandates that the Secretary 
create regulations requiring that food carriers use sanitary 
transportation practices. Section 416(c)(1)(E) of the FD&C Act states 
``the regulations under section (b) shall--(1) prescribe such practices 
as the Secretary determines to be appropriate relating to-- . . . (E) 
recordkeeping . . .'' The way that the statute is structured implies 
that lack of or incomplete records in section 416(c)(1)(E) of the FD&C 
Act would lead to the food being adulterated under section 402(i) of 
the FD&C Act. The establishment of records requirements under this rule 
is consistent with the statutory purpose of the 2005 SFTA. It is clear 
from the statute and the legislative history that Congress intended 
recordkeeping to be one of the requirements for maintaining sanitary 
food transportation practices (See section 416 of the FD&C Act and S. 
Rep. No. 109-120, at 46 (2005) (Ref. 25)).
    Furthermore, the Senate report (S. Rep. No. 109-120, at 46 (2005)) 
(Ref 25) expresses Congress' intention to grant FDA authority to deem 
food adulterated on recordkeeping grounds. That report states that SFTA 
``would amend section 402 of the Federal Food, Drug, and Cosmetic Act . 
. . to provide that food is adulterated if transported in violation of 
safe transportation practices prescribed in the new section 416 of the 
FD&C Act.''
    In the seafood HACCP final rule (60 FR 65096 at 65100) we noted 
that in National Confectioners Association v. Califano, 569 F.2d 690 
(D.C. Cir. 1978), the courts upheld FDA's authority to issue 
regulations under section 402(a)(4) of the FD&C Act that included 
recordkeeping requirements, when challenged on the grounds that they 
would permit prosecution where processing conditions were completely 
sanitary, but the records were deficient.

[[Page 20112]]

Such an outcome, it was argued, would be beyond the scope of section 
402(a)(4) of the FD&C Act. Citing Toilet Goods Association v. Gardner, 
387 U.S. 158 (1967), the court rejected this argument and held that the 
primary consideration was whether the statutory scheme as a whole, not 
just section 402(a)(4) of the FD&C Act, justified the Agency's 
regulations. (See Nat'l Confectioners Ass'n, 569 F.2d 690 at 693.) The 
court pointed out that this consideration involved an inquiry into 
practicalities as well as statutory purpose, i.e., enforcement problems 
encountered by FDA and the need for various forms of supervision in 
order to accomplish the goals of the FD&C Act. (Id.)
    Thus, the necessary conditions for compliance with these 
regulations encompass all of the requirements in this final rule, 
including those that may not appear to directly affect the safety of 
the food, such as training and records. The SFTA of 2005 does not 
differentiate between physical conditions indicating food safety risk 
and requirements, such as training and recordkeeping.
    However, we recognize the concerns expressed by these comments and 
do not believe that the SFTA of 2005 changes the way we enforce our 
regulations. Before initiating enforcement action, we will consider all 
circumstances surrounding the deviation(s), e.g., the nature of the 
deviation, from these regulations as we have in the application of 
other preventive control-type regulations, such as the seafood HACCP 
regulation and the Juice HACCP regulation.
    (Comment 48) One comment states that the rule does not address the 
obligations of carriers if shelf stable food is compromised during 
transit or while on a dock or being loaded onto a trailer. The comment 
states that when a shipment is damaged in transit, or during loading or 
unloading, the carrier will frequently transport the shipment of 
damaged goods to a location of the shipper's choice. The commenter asks 
us, if the carrier is only qualified to handle shelf stable food, can 
the carrier continue to handle the shelf stable food with compromised 
packaging? The comment also asks whether the carrier would be required 
to hire another carrier who has chosen to comply with the record 
keeping and training requirements of the proposed rule to handle the 
return of such shipments.
    (Response 48) We would have no concerns about the carrier 
transporting the damaged goods to a location specified by the shipper 
because, under Sec.  1.908(a)(6), an evaluation must be performed 
before further distribution to determine whether the food has been 
rendered unsafe.

C. What definitions apply to this subpart? (Sec.  1.904)

    We proposed to establish several definitions in Sec.  1.904. In 
table 6, we describe revisions to the proposed definitions and 
following the table we respond to comments related to these provisions. 
We did not make changes to the definitions of adequate, animal food, 
bulk vehicle, cross-contact, food not completely enclosed by a 
container, pest, transportation, and vehicle.

      Table 6--Sec.   1.904 What Definitions Apply to This Subpart?
------------------------------------------------------------------------
                   Definition                            Revision
------------------------------------------------------------------------
Carrier.........................................  Revised definition to
                                                   specify that carrier
                                                   means a person who
                                                   physically moves food
                                                   by rail or motor
                                                   vehicle in commerce
                                                   within the United
                                                   States.
Farm............................................  Applied farm
                                                   definition given in
                                                   Sec.   1.227 (21 CFR
                                                   1.227).
Food............................................  Removed the term
                                                   because it is already
                                                   defined in section
                                                   201 of the FD&C Act.
Full-time equivalent employee...................  A new definition.
                                                  Full-time equivalent
                                                   employee is a term
                                                   used to represent the
                                                   number of employees
                                                   of a business entity
                                                   for the purpose of
                                                   determining whether
                                                   the business is a
                                                   small business. The
                                                   number of full-time
                                                   equivalent employees
                                                   is determined by
                                                   dividing the total
                                                   number of hours of
                                                   salary or wages paid
                                                   directly to employees
                                                   of the business
                                                   entity and of all of
                                                   its affiliates and
                                                   subsidiaries by the
                                                   number of hours of
                                                   work in 1 year, 2,080
                                                   hours (i.e., 40 hours
                                                   x 52 weeks). If the
                                                   result is not a whole
                                                   number, round down to
                                                   the next lowest whole
                                                   number.
Microorganisms..................................  Removed the term
                                                   because not needed
                                                   with revised
                                                   provisions in Sec.
                                                   Sec.   1.906 and
                                                   1.908.
Loader..........................................  A new definition.
                                                  Loader means a person
                                                   that loads food onto
                                                   a motor or rail
                                                   vehicle during
                                                   transportation
                                                   operations.
Non-Covered Business............................  Specified the limit of
                                                   $500,000 as adjusted
                                                   for inflation, in
                                                   average annual
                                                   revenues, calculated
                                                   on a rolling basis,
                                                   during the 3-year
                                                   period preceding the
                                                   applicable calendar
                                                   year. For the purpose
                                                   of determining an
                                                   entity's 3-year
                                                   average revenue
                                                   threshold as adjusted
                                                   for inflation, the
                                                   baseline year for
                                                   calculating the
                                                   adjustment for
                                                   inflation is 2011.
                                                  Added ``loader'' to
                                                   list of potential non-
                                                   covered businesses.
Person..........................................  Removed the term
                                                   because it is already
                                                   defined in section
                                                   201.
Receiver........................................  Revised definition to
                                                   specify that receiver
                                                   means any person who
                                                   receives food at a
                                                   point in the United
                                                   States after
                                                   transportation,
                                                   whether or not that
                                                   person represents the
                                                   final point of
                                                   receipt for the food.
Shelf Stable Food...............................  Removed the
                                                   definition, not
                                                   needed for revised
                                                   definition of
                                                   ``transportation
                                                   operations''.
Shipper.........................................  Revised to specify
                                                   that shipper means a
                                                   person who arranges
                                                   for the
                                                   transportation of
                                                   food in the United
                                                   States by a carrier
                                                   or multiple carriers
                                                   sequentially.
                                                  Provided examples of
                                                   shipper, such as the
                                                   manufacturer or a
                                                   freight broker.
Small Business..................................  Specified the limit of
                                                   $27,500,000 annual
                                                   receipts.
                                                  Specified that
                                                   employee limit is
                                                   fewer than 500 full-
                                                   time equivalent
                                                   employees.
Time/Temperature Control for Safety (TCS) Food..  Removed the
                                                   definition, not
                                                   relevant to revised
                                                   temperature control
                                                   provisions.
Transportation..................................  Revised to specify
                                                   that transportation
                                                   means any movement of
                                                   food by motor vehicle
                                                   or rail vehicle in
                                                   commerce within the
                                                   United States.
Transportation Equipment........................  Removed ``other than
                                                   vehicles'' for
                                                   clarity.

[[Page 20113]]

 
Transportation Operation........................  Removed ``solely'' and
                                                   ``shelf stable'' to
                                                   specify that
                                                   transportation
                                                   operations do not
                                                   include activities on
                                                   a food completely
                                                   enclosed by a
                                                   container except a
                                                   food that requires
                                                   temperature control
                                                   for safety.
                                                  Added that
                                                   transportation
                                                   operations do not
                                                   include any
                                                   activities associated
                                                   with the
                                                   transportation of
                                                   ``food contact
                                                   substances as defined
                                                   in section 409(h)(6)
                                                   of the FD&C Act,''
                                                   ``human food
                                                   byproducts
                                                   transported for use
                                                   as animal food
                                                   without further
                                                   processing,'' or live
                                                   food animals ``except
                                                   molluscan
                                                   shellfish''.
                                                  Removed ``for raw
                                                   agricultural
                                                   commodities'' to
                                                   specify that
                                                   transportation
                                                   operations do not
                                                   include any
                                                   transportation
                                                   activities performed
                                                   by a farm.
------------------------------------------------------------------------

1. Adequate
    We proposed to define the term ``adequate'' to mean that which is 
needed to accomplish the intended purpose in keeping with good public 
health practice. We are finalizing this definition as proposed.
    (Comment 49) One comment states that the term ``adequate'' is not 
suitable for a rule intended to achieve compliance with best 
transportation practices focused on reducing the risks of the 
adulteration of food products. The comment suggests that instead we 
should use the term ``to guarantee,'' which the comment defines as 
meaning ``to ensure and protect from any risk or need,'' to avoid 
ambiguity that might cause confusion and result in public health 
hazards.
    (Response 49) We decline this request. The term ``adequate'' is a 
long-standing term that we defined in its current form when we first 
established Current Good Manufacturing Practices (cGMP) requirements 
for manufacturing, packing and holding food in 1969 (see 34 FR 6977 at 
6978, `` `Adequate' means that which is needed to accomplish the 
intended purpose in keeping with good public health practice.''). The 
requirements established in this rule address broadly applicable 
procedures and practices and our use of the term ``adequate'' is 
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. We are not aware that the term has caused 
confusion in its use with the cGMPs and the comment does not provide 
any examples of how our use of the term ``adequate'' may create 
confusion that might result in public health hazards.
2. Animal Food
    We proposed to define the term ``animal food'' to mean food for 
animals other than man, including pet food, animal feed, and associated 
raw materials and ingredients. We are finalizing this definition as 
proposed.
    (Comment 50) A few comments state that raw materials should not be 
included in this definition because processing these materials into 
feed ingredients and finished animal food products after they have been 
transported to processing facilities removes many, if not all, of the 
hazards that may be associated with the transportation of the raw 
materials. One of the comments also notes that the Association of 
American Feed Control Officials (AAFCO) Model Regulations exempt raw 
materials (such as meat scraps) from regulation because they are not 
suitable for use in animal feed without further processing.
    (Response 50) We decline to change the definition of animal food. 
While the transportation of raw materials for animal feed manufacture 
may not require the same degree of sanitary control as the transport of 
finished animal feed, there may be circumstances in which processing 
the raw materials may not remove all health hazards, e.g., fertilizer 
residue from a prior cargo hauled in a vehicle, that might be caused by 
the insanitary transportation of the raw materials. We have added 
provisions to Sec.  1.908(a)(3) of this final rule to provide 
sufficient flexibility to allow persons engaged in the transport of raw 
materials, feed ingredients, or finished animal food to use sanitary 
transportation practices that are appropriate for their circumstances.
3. Bulk Vehicle
    We proposed to define the term ``bulk vehicle'' to mean a tank 
truck, hopper truck, rail tank car, hopper car, cargo tank, portable 
tank, freight container, hopper bin, or any other vehicle in which food 
is shipped in bulk, with the food coming into direct contact with the 
interior surfaces of the vehicle. We are finalizing this definition as 
proposed.
    (Comment 51) One comment asks us to add terms such as ``gondola'' 
to the examples included in this definition in the interests of 
clarity.
    (Response 51) We decline to change the definition based on this 
request. We are using the definition of ``bulk vehicle'' in this rule 
exactly as it appears in the 2005 SFTA and as incorporated into section 
416 of the FD&C Act. However, we note that the list of examples 
included in the definition is not intended to be comprehensive or all 
inclusive with respect to the types of vehicles that are bulk vehicles. 
We define the term to include ``any other vehicles in which food is 
shipped in bulk, with the food coming into direct contact with the 
vehicle.''
    (Comment 52) Some comments state that in several respects, our 
definition of bulk vehicle is overly broad in scope. According to one 
commenter, the term ``hopper bin,'' for example, can be inferred to 
mean a grain hopper bottom storage bin that is part of a storage 
facility, and not a piece of transportation equipment. The comment 
requests that we delete the term ``hopper bin'' from this definition. 
Another comment asks us to explicitly exclude vehicles used to 
transport fruit and vegetable RACs from the definition because many 
RACs are thermally processed with a kill step or are cooked by the 
consumer before being consumed.
    (Response 52) We decline these requests. A hopper bin constructed 
as part of a facility and used for storage would not be considered 
transportation equipment and therefore would not be subject to this 
rule. A hopper bin on a truck or other conveyance subject to this rule, 
however, is a piece of transportation equipment and therefore is 
subject to this rule. We also note that while some RACs that are 
transported in a bulk vehicle may undergo a kill step process or 
cooking before being consumed, there may be circumstances in which 
controls, e.g., the cleaning of a vehicle that was last used to haul a 
nonfood item, are necessary to ensure the sanitary transportation of 
certain types of RACs. We have added provisions to Sec.  1.908(a)(3) of 
this rule to provide sufficient flexibility to allow persons engaged in 
the transport of food intended for further processing to employ 
sanitary transportation practices that are appropriate for their 
circumstances.

[[Page 20114]]

4. Carrier
    We proposed to define the term ``carrier'' to mean a person who 
owns, leases, or is otherwise ultimately responsible for the use of a 
motor vehicle or rail vehicle to transport food. The definition also 
specified that the carrier is responsible for all functions assigned to 
a carrier in this subpart even if they are performed by other persons, 
such as a driver that is employed or contracted by a trucking firm, and 
that a carrier may also be a receiver or a shipper if the person also 
performs the functions of those respective persons as defined in this 
subpart. In the final rule, as explained in the discussion of Sec.  
1.908(a)(1), we have added a general provision to that section about 
the multiple roles that can be played by a single entity to replace the 
separate provisions we had included in the proposed definitions of 
``carrier,'' ``shipper'' and ``receiver''. We are finalizing the 
definition for ``carrier'' to mean a person who physically moves food 
in commerce and clarifying that a carrier does not include any person 
who transports food while operating as a parcel delivery service. We 
explain these changes in the responses to the next 3 comments.
    (Comment 53) Some comments oppose defining the term ``carrier'' to 
mean a person who owns, leases, or is otherwise ultimately responsible 
for the use of a motor vehicle or rail vehicle to transport food. These 
commenters express concern that this definition would result in the 
inappropriate and unworkable application of this rule's requirements to 
railroad operators for the following reasons.
     Railroad operators in many cases do not own or lease the 
railcars they transport, are not responsible for their storage when 
they are stored in private facilities, and exercise no control over the 
cars other than to inspect them for mechanical soundness during the 
transportation process.
     The shipper or loader is generally responsible for 
inspecting a railcar to ensure that it is suitable for the particular 
food cargo, regardless of who owns the car.
     Railroad operators do not have the ability to ensure that 
the shipper's sanitary and temperature control requirements are met 
before or during transportation when, as is common in freight railroad 
transport, other parties, e.g., the shipper, assume the responsibility 
for preparing the railcars for loading, maintain their operating 
conditions during transportation, and deliver the loaded car to the 
railroad operator for transport.
     Railroad operators generally do not clean the cars they 
provide and do not maintain documented cleaning procedures.
     The use of railcars in interchange service, in which 
railroads convey freight cars from other companies over their lines 
would likely mean that the railroad operator would not be able to 
provide information about the identity of a bulk vehicle's previous 
cargoes and its most recent cleaning if requested by the shipper.
    The commenters note that for the stated reasons, railroad operators 
cannot meet requirements of this rule assigned to carriers under 
proposed Sec. Sec.  1.906 and 1.908.
    These comments also contrast rail carrier and motor carrier food 
transportation operations, noting that motor carriers generally own the 
vehicles they provide for transport and are directly involved in 
transportation operations, such as the loading and unloading of the 
trailers that they haul, and therefore can comply with requirements 
assigned to the carrier in Sec. Sec.  1.906 and 1.908 of the proposed 
rule.
    Finally, one comment asks us to establish separate definitions for 
motor and rail carriers which would assign appropriate responsibilities 
for each of the two distinct types of carriers. Another comment asks us 
to establish a definition specific to railroad carriers in this final 
rule, which would simply define a ``railroad carrier'' as a person 
providing railroad transportation services.
    (Response 53) We carefully considered these comments and we agree 
that our proposed definition of the term ``carrier,'' when combined 
with the structure of the proposed requirements at Sec.  1.908, which 
detail the required interrelationships between carriers, shippers and 
receivers, would establish requirements that some persons subject to 
the definition, e.g., some railroad operators, typically cannot meet, 
and which are currently performed by other parties, e.g., the shipper. 
Because it is our intent to pattern this rule on existing industry best 
practices, we agree that we should not reassign responsibilities for 
activities that affect food sanitation during transportation in this 
final rule in a manner that is so fundamentally divergent from current 
practice.
    We recognize that, in practice, the person who assumes 
responsibility for functions assigned to a carrier under Sec.  1.908 of 
the proposed rule is identified by mutual agreement between the shipper 
and that person, e.g., the trucking firm, the railroad operator, the 
railcar management firm, or that the shipper may itself assume the 
responsibility. We also recognize, as one of the comments mentions, 
that railroad operators typically do not assume these responsibilities. 
Nonetheless, we are aware that, though not common in the rail 
transportation of food, some railroad operators do perform functions 
that affect the sanitary condition of a railcar during transportation 
of the food, e.g., monitor the temperature of the car. However, we do 
not agree that a separate definition for rail carriers is the 
appropriate solution, because some rail carriers, in fact, perform 
functions that are typically performed by motor carriers. Rather, we 
have concluded that the appropriate solution with regard to the 
definition and the overall carrier regulatory requirements is: (1) A 
simplified definition of carrier that ties it to the movement of the 
food; (2) removal from the carrier definition of any assignment of 
duties; and (3) a default assignment of responsibility to the shipper 
for the activities assigned to carriers in the proposed rule, unless a 
written contract between the shipper and carrier assigns them to the 
carrier (or another party covered by this regulation, as may be the 
case). We are aware that contracts for services that impact food safety 
(e.g., monitoring temperatures, cleaning vehicles) generally are in 
place when rail or motor carriers provide such services. Therefore, 
linking responsibility for the carrier to perform such functions to the 
existence of a contract with the shipper, in which such functions are 
specified, seems appropriate and consistent with current industry best 
practice.
    For these reasons, we have revised the definition of carrier to 
mean a person who physically moves food by rail or motor vehicle in 
commerce in the United States. We have removed from the definition the 
proposed sentence that assigned duties to the carrier, because of the 
consequences of such assignment, especially relative to rail carriers, 
as discussed in this document, and because, upon further consideration, 
we view such language to be inappropriate for a definition. We have 
also removed from the definition the proposed sentence that stated that 
a carrier may also be a receiver or a shipper if the person also 
performs the functions of those respective persons. While we affirm 
that this statement is valid, we have consolidated this and similar 
statements in the proposed definitions of shippers and receivers in the 
regulatory text at Sec.  1.908(a)(1).
    (Comment 54) A few comments urge us to consider that home grocery 
delivery services may originate from locations other than food

[[Page 20115]]

establishments, such as a distribution center. According to the 
comments, the transportation of the food from distribution center to 
the consumer would be subject to the proposed requirements for a 
carrier. The commenters note, however, that there would be no receiver 
in this scenario because the definition of receiver explicitly excludes 
consumers. The comments ask us to revise the final rule so that it does 
not impose unnecessary regulatory burdens for home grocery deliveries 
originating at locations other than food establishments.
    (Response 54) Home grocery delivery operations at food distribution 
centers are generally permitted by States as retail establishments and, 
therefore, would be included in a waiver of certain transportation 
operations performed by such retail food establishments. 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 
retail food establishments 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. As we stated in section III.E., 
we intend to publish a waiver in the Federal Register addressing this 
class of persons prior to the compliance date of this final rule.
    (Comment 55) A participant in one of the public meetings we held on 
the proposed rule asked whether this rule applies to food shipped by 
the U.S. Postal Service or by private small parcel carriers. One 
submitted comment states that the impact of the rule would be 
significant and costly if it is applied to small-parcel common 
carriers, and therefore asks us to affirmatively state that small-
parcel common carriers will be excluded from the definition of 
``carrier.'' The comment notes that small-parcel common carriers handle 
millions of packages per day containing a broad range of goods, 
including clothing, shoes, food products, electronics products, and 
books. The comment asserts that requiring these carriers to understand 
the unique shipping requirements for every product that they transport 
would be unduly burdensome and nearly impossible to accomplish. The 
comment further argues that if FDA requires that small-parcel common 
carriers meet the requirements imposed on dedicated food carriers, some 
common parcel carriers, especially large-scale common carriers, will 
respond by simply excluding all food shipments from their operations. 
According to the commenter, this result would likely reduce the 
availability of some of the most cost-effective transportation channels 
for certain food shippers, even where there have been no demonstrated 
food safety risks associated with their food product delivery 
operations. Finally, the commenter suggests that the more appropriate 
way to ensure food safety under these circumstances would be to require 
the shipper of any small parcel to ensure that the selected method of 
transportation is appropriate for the food product at issue.
    (Response 55) We agree that it is not appropriate to subject the 
operations of the U. S. Postal Service or private delivery services 
delivering parcels to consumers to this rule, given that these carriers 
transport a broad range of items and do not offer transportation 
services tailored to the transportation of food products. We, 
therefore, have added a provision to the definition of the term 
``carrier'' in Sec.  1.904 of this final rule stating that the term 
does not include any person who transports food while operating as a 
parcel delivery service. Our expectation is that the person shipping 
the package would ensure that the selected method and circumstances of 
transportation are appropriate for the food product at issue, including 
food that is delivered by small-parcel common carriers.
5. Cross-Contact
    We proposed to define the term ``cross-contact'' to mean the 
unintentional incorporation of a food allergen as defined in section 
201(qq) of the FD&C Act into food, except animal food. We did not 
receive any comments on this definition and are finalizing it as 
proposed.
6. Farm
    We proposed to define the term ``farm'' to mean a facility in one 
general physical location devoted to the growing and harvesting of 
crops, the raising of animals (including seafood), or both. The 
proposed definition of ``farm'' included facilities that pack or hold 
food, regardless of whether all food used in such activities is grown, 
raised, or consumed on that farm or another farm under the same 
ownership. We are revising the definition of ``farm'' in this rule to 
be consistent with the definition of ``farm'' used in other FSMA 
rulemakings. We discuss our considerations of the comments we received 
on the definition of ``farm'' in the response to Comment 55 and, 
additionally, in our response to Comment 8.
    (Comment 56) Several comments that address provisions of the 
proposed definition of ``farm'' suggest that the definition include 
terms such as a ``facility,'' or an ``establishment,'' or a ``place.'' 
Other comments suggest that the definition should include consideration 
of the locations and the numbers of the structures that constitute a 
farm.
    (Response 56) As we explained in our response to Comment 8, we have 
revised the definition of the term ``farm'' in this final rule to align 
it with the revised definition of the term in 21 CFR 1.227, which was 
recently established in the FSMA preventive control for human food 
final rule (80 FR 55908 at 55925). The comments that we received for 
this rulemaking address provisions of the farm definition that have 
already been addressed in the rulemaking for preventive controls for 
human food. Therefore, there is no need for us to address these issues 
further in this rulemaking.
7. Food
    We included the definition of the term ``food'' in the proposed 
rule just as the term is defined in section 201(f) (21 U.S.C. 321(f)) 
of the FD&C Act. We have deleted this definition from this final rule, 
however, because Sec.  1.904 of the rule clearly states that ``[t]he 
definitions and interpretations of terms in section 201 of the [FD&C 
Act] are applicable to such terms when used'' in this rule. Food 
includes animal food and food also food subject to the FMIA, the PPIA, 
and the EPIA.
    (Comment 57) One comment asks us to explicitly exclude food contact 
shipping and storage equipment from the rule's definition of ``food.'' 
The comment also asks us to clarify that empty food contact shipping 
and storage equipment will be regulated exclusively as ``transportation 
equipment'' under this rule. Finally, the comment asks us to clarify 
that equipment suppliers, including food contact equipment suppliers, 
are not shippers, carriers or receivers of ``food.''
    (Response 57) The definition of ``food'' given in section 201(f) of 
the FD&C Act applies to this term as used in this rule. Under section 
201(f), the term ``food'' means (1) articles used for food or drink for 
man or other animals, (2) chewing gum, and (3) articles used for 
components of any such article. Shipping and storage equipment that is 
meant to contact food is not food and would be regulated exclusively as 
``transportation equipment'' under this rule. Therefore, persons 
involved in the transportation of such equipment are not shippers, 
carriers or receivers of

[[Page 20116]]

``food.'' However, the food contact surfaces of such equipment must 
comply with any other applicable regulations we have established, e.g., 
food additive regulations, for any components that may migrate into 
food under their intended conditions of use.
    (Comment 58) A few comments ask us to exclude food contact 
substances as defined in section 409(h)(6) of the FD&C Act from the 
scope of this rule by excluding them from the definition of ``food.'' 
One of the comments notes that we excluded food contact substances from 
the definition of ``food'' in the food facility registration 
regulations in 21 CFR 1.227(b)(4). It further states that requiring 
manufacturers, shippers, receivers, and carriers of food contact 
substances to comply with the sanitary transportation requirements 
would impose a significant burden with respect to the transportation of 
products that present a very low food safety risk and for which any 
risk is already effectively managed.
    (Response 58) We partially agree with these comments. In the 1990 
SFTA, Congress included food additives along with other substances 
defined in the FD&C Act in designating the scope of the regulations 
that it directed DOT to issue. We take this to mean that Congress 
recognized that food could be made unsafe as a result of insanitary 
food additive transportation practices. Food contact substances are 
``food additives'' and are also ``food'' as defined in the FD&C Act. In 
the absence of language in the 2005 SFTA that explicitly excludes food 
contact substances from regulation as food, we would not agree with the 
comment's view that food contact substances should not be considered to 
be ``food'' within the meaning of this rule.
    However, section 416(c)(1) of the 2005 SFTA states that we shall 
prescribe sanitary transportation practices that we determine to be 
appropriate in issuing this rule. We, therefore, are revising the 
definition of transportation operations to exclude food contact 
substances as defined in section 409(h)(6) of the FD&C Act. Factors 
inherent to the transportation and downstream handling of food contact 
substances, described in this section, would strongly support that 
there is little risk of food products becoming adulterated because of 
insanitary food contact substance transportation practices. We agree, 
as one comment notes, that food contact substances are protected during 
transportation with additional outer packaging. In addition, the 
pathogenic microorganisms that are deleterious to conventional foods 
are not known to be a risk for food contact substances. We also note 
that the handling and processing that these substances undergo during 
the manufacturing of finished food contact articles, such as curing, 
drying, and extrusion, often involve very high temperatures, creating 
conditions under which there is little possibility that any 
microorganisms that might be present would survive. The nature of 
finished food contact articles also ensures that the risk of microbial 
contamination is very low. We, therefore, have determined that 
requirements under this rulemaking for the sanitary transportation of 
food contact substances are not necessary.
8. Food Not Completely Enclosed by a Container
    We proposed to define the term ``food not completely enclosed by a 
container'' to mean any ``food that is placed into a container in such 
a manner that it is partially open to the surrounding environment.'' We 
stated in the proposed rule that examples of such containers would 
include an open wooden basket or crate, an open cardboard box, a vented 
cardboard box with a top, or a vented plastic bag, but would not 
include food transported in a bulk vehicles. We are finalizing this 
definition as proposed.
    (Comment 59) One comment objects to our proposed inclusion of food 
packaged in vented cardboard cartons with tops as an example of ``food 
not completely enclosed by a container.'' Several comments disagree 
that the use of vented cartons by the tree fruit industry poses a 
measurable risk of contamination to fruit during transportation. One 
comment observes that vented cardboard cartons with tops are a commonly 
used for cooling fruit and contribute to the maintenance of fruit 
quality. According to the comments, vented cartons bearing fruit are 
stacked on pallets before being placed in refrigerated trucks by 
forklifts, and they are removed the same way and without ever coming 
into direct contact with the trucks' interior surfaces. The comments 
also assert that it is rare for loads of fruit packaged this way to be 
transported with any other food products, further reducing the risk of 
cross-contamination or adulteration. Finally, the comments also assert 
that no evidence of any threat to food safety has emerged over the many 
decades that the tree fruit industry has used these types of cartons 
for packaging and transportation.
    (Response 59) We agree that when sanitary transportation practices 
are followed in the transportation of tree fruit, there should be no 
significant risk of contamination of the product. However, we decline 
the request to exclude vented cardboard cartons from the definition of 
``food not completely enclosed by a container.'' The purpose of this 
rulemaking is to prescribe sanitary transportation practices to ensure 
that food does not become unsafe during transportation. We have 
determined that it is necessary to establish requirements related to 
the transportation of foods not completely enclosed by a container, 
including food transported in vented cardboard cartons with tops, 
because food, including tree fruits, packaged this way could be 
susceptible to environmental contamination, for example, if a vehicle 
used for transport is not in appropriate sanitary condition for the 
transportation operation.
    (Comment 60) One comment states that it is unclear what we mean by 
a ``completely enclosed container'' as it relates to storage practices 
during loading and transportation operations. The comment asks whether 
this means food must be enclosed by a cardboard box or a plastic 
wrapped pallet, or whether food must be enclosed by a moisture 
impervious container such as ones made out of heavy plastic, glass or 
metal. The commenter states that it has seen ``extreme examples of 
cross contamination, such as raw poultry on ice, stored above fresh 
produce with bloody ice falling into the produce.'' The commenter asks 
us to provide clearer language.
    (Response 60) We consider a ``completely enclosed container'' to be 
one that physically separates the food from the environment and 
functionally protects the food from environmental contamination during 
transportation. We would not consider items such as pallet wrap, which 
have the primary purpose of facilitating the handling of pallets, to be 
food containers. We provided examples of such containers in the 
proposed rule (79 FR 7006 at 7015), e.g., a metal can, a glass or 
plastic bottle, or a sealed bag or box.
9. Full-Time Equivalent Employee
    ``Full-time equivalent employee'' is a new term in this rule and is 
used to represent the number of employees of a business entity for the 
purpose of determining whether the business is a small business. The 
number of full-time equivalent employees is determined by dividing the 
total number of hours of salary or wages paid directly to employees of 
the business entity and of all of its affiliates and subsidiaries by 
the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 
weeks). If the result is not a whole number, round down to the next 
lowest whole

[[Page 20117]]

number. We are adding this term to the rule to clarify its use in the 
revised definition of ``small business'' in this rule. The use of this 
term is consistent with the use of the same term in the preventive 
controls rules for both human and animal food.
10. Loader
    We are adding the term ``loader'' to this rule and specifying that 
it means a person that loads food onto a motor car or rail vehicle used 
during transportation operations. We are adding this term in response 
to comments that indicated that there were certain functions assigned 
in the proposed rule that were typically performed by a segment of the 
transportation industry known as loaders and so we have added this 
function to the rule.
11. Microorganisms
    We proposed to define the term ``microorganisms'' to mean yeasts, 
molds, bacteria, viruses, protozoa, and microscopic parasites and to 
include species that have public health significance. We proposed to 
define the term ``undesirable microorganisms'' to include those 
microorganisms that are of public health significance, that subject 
food to decomposition, that indicate that food is contaminated with 
filth, or that otherwise may cause food to be adulterated. We have 
removed this term as explained in the response to Comment 61.
    (Comment 61) One comment states that although these definitions are 
familiar from the existing food cGMP regulations at 21 CFR part 110 
(which have been revised in the preventive controls for human food 
final rule and are now in 21 CFR part 117, subpart B), they provide 
little assistance for purposes of identifying foods that can support 
the rapid growth of undesirable microorganisms in the absence of 
temperature controls. Other comments state that we should clarify that 
microorganisms that have only the potential to cause spoilage, without 
posing food safety risks, should not be excluded from these definitions 
of microorganisms.
    (Response 61) We included a definition for the term 
``microorganisms'' in the proposed rule that was to be applied to 
requirements in proposed Sec. Sec.  1.906 and 1.908 that addressed 
measures necessary to prevent conditions that could lead to the rapid 
growth of undesirable microorganisms in food because of the use of 
insanitary transportation equipment and transportation practices. As we 
explained in our response to Comment 89, we have revised the language 
in these sections of this final rule to no longer refer to the term 
``undesirable microorganisms.'' As a result of this revision, there is 
no longer a need to include a definition for the term 
``microorganisms.''
12. Non-Covered Business
    We proposed to define the term ``non-covered business'' to mean a 
shipper, receiver, or carrier engaged in transportation operations that 
has less than $500,000 in total annual sales. We have changed the 
annual sales qualifier in this provision to an annual revenue qualifier 
because under this rule, this definition applies to firms, e.g., 
loaders that do not sell products. In addition, to be consistent with 
the models used in other FSMA rulemakings (e.g., the preventive 
controls final rules) for similar calculations, we have revised this 
definition to provide that the annual revenue calculation is based upon 
an average value for 3 years preceding the applicable calendar year, 
and allows for adjustment for inflation.
    (Comment 62) We received a large number of comments regarding this 
proposed provision. Most of them oppose granting any kind of size-based 
exclusion. Several themes emerge from the comments that we received 
opposing the inclusion of a size-based exclusion in this rule. Many of 
the comments ask us to create a ``very small'' category of businesses 
which would be subject to fewer requirements than other firms. Some of 
these comments state that the proposed exclusion provision leaves the 
most problematic group of transporters, operators of small box trucks, 
uncovered by this rule, citing the findings that we discussed in the 
proposed rule (79 FR 7006 at 7024), of the 2007 Interstate Food 
Transportation Assessment Project (Ref. 6). Some comments expressed the 
view that that all members of the food supply chain, regardless of 
size, must share responsibility in ensuring food safety. Some comments 
criticize the proposed exclusion for lacking a statutory basis, for not 
being risk-based, or for lacking merit and being unnecessary. One 
comment opposes the proposed exclusion on the grounds that we have 
failed to explain why the proposed rule's requirements would be 
prohibitive for those firms capable of qualifying for the exemption. 
Other commenters state that we should not grant any exclusions because 
the proposed requirements are similar to food cGMPs, which we impose on 
almost all food processors.
    (Response 62) We articulated our reasons in the proposed rule (79 
FR 7006 at 7014) for excluding certain businesses, i.e., a ``non-
covered business,'' from the requirements of this rule. We stated that 
we want to treat firms subject to this rule comparably to those firms 
that are subject to the FSMA preventive controls rules. We also stated 
that we want to treat carriers, who are not subject to the preventive 
controls rules, in the same manner as we treat other firms engaged in 
food transportation operations that are also subject to this rule. We 
chose to do this by providing an exclusion for these businesses, 
recognizing that their transportation operations are also, and will 
continue to be, covered under the adulteration provisions and other 
applicable provisions of the FD&C Act and all of our applicable 
implementing regulations. In light of this, and recognizing businesses 
that would qualify for this size-based exclusion would have fewer 
resources to dedicate to complying with this rule, we chose to exclude 
these businesses from this rule rather than create a separate category 
of very small business that would be subject to fewer requirements than 
other firms. We estimate that the removal from coverage of entities 
less than $500,000 in average annual revenues, as we have set out in 
this final rule, would result in only about 5 percent of food shipments 
not being covered by this rule. The risk of any foodborne outbreak 
associated with this narrow range of shipments therefore is, thus, 
necessarily limited in scope. Notwithstanding the information on small 
box trucks contained in the 2007 Interstate Food Transportation 
Assessment Project, we are not aware of data that supports the 
assertion of some comments that shipments by the smallest firms, i.e., 
those that would meet the definition of a non-covered business, present 
a greater food safety risk than those of larger firms. Comments we 
received on the proposed rule have not presented any information tying 
risk of adulteration to firm size to persuade us that we should apply 
the requirements of this rule to the businesses we proposed to exclude. 
Operators of small box trucks would be covered unless they meet the 
definition of a non-covered business.
    To further expand upon our thinking, we note that the preventive 
controls rules exempted ``qualified facilities'' as defined by the 
FSMA, from the requirement for hazard analysis and risk-based 
preventive controls and instead established very limited requirements 
(essentially statutorily mandated attestations by the firm to FDA) 
specific to this category of

[[Page 20118]]

facilities, e.g., ``very small businesses,'' as defined in these rules. 
While the 2005 SFTA does not address ``qualified'' facilities and does 
not require us to include provisions in this rule for very small 
businesses, we determined in considering the costs and benefits of this 
rule, that a category of businesses, i.e., ``non-covered'' businesses, 
should remain subject to the adulteration provisions and other 
applicable provisions of the FD&C Act and applicable implementing 
regulations, but not be subject to the requirements of this rule. We 
point out that many non-covered businesses that are shippers, loaders 
and receivers, would be subject to the cGMP provisions in Sec.  117.93 
of the preventive controls rule that address transportation practices. 
We also point out that our proposed approach would not absolve a non-
covered business from the responsibility to conduct its transportation 
operations in compliance with the adulteration provisions of the FD&C 
Act, upon which this rule is based.
    Therefore we are retaining the exclusion for non-covered businesses 
from the requirements of this rule. However, to further promote the 
application of sanitary transportation practices throughout the 
industry, we will also consider establishing guidance for 
transportation activities carried out by non-covered businesses.
    (Comment 63) Some comments are concerned about possible unintended 
consequences potentially associated with size-based exclusions, 
including confusion that could result when a covered firm attempts to 
do business with a non-covered firm, or the exit of small firms from 
the food transportation industry because shippers may discontinue doing 
business with carriers that are not subject to the rule. One comment 
opposed to the proposed provision expresses the view that small 
shippers, loaders, carriers, and receivers excluded from the rule based 
on size still could be penalized if the food they are transporting 
becomes adulterated because any party that introduces or receives an 
adulterated food product in interstate commerce may be held legally 
responsible.
    (Response 63) Firms engaged in food transportation, including those 
exempt from this rule, must comply with all of the generally applicable 
requirements of the FD&C Act, including those that prohibit the holding 
of food under insanitary conditions whereby the food may become 
contaminated with filth or be rendered injurious to health. While 
differing requirements have the potential to affect business 
relationships among firms and their interactions with regulatory 
agencies, we believe that agencies and the marketplace can adapt 
appropriately, and that firms will not be unduly inconvenienced by 
them. Furthermore, if firms that are not covered by this rule because 
of their size voluntarily chose to meet the rule's requirements, for 
example, for competitive business purposes, there are resources, such 
as FDA and industry issued guidance on sanitary food transportation and 
training in sanitary food transportation practices, available to them.
    (Comment 64) One comment states that the proposed exclusion may 
have the unintended consequence of motivating food transportation firms 
to create subsidiary companies for the purpose of dispersing their 
annual sales so that each newly created, related company would have 
less than $500,000 in annual sales, and therefore qualify for the 
exclusion.
    (Response 64) In the proposed rule (79 FR 7006 at 7014) and in the 
responses to the previous comments, we articulated our reasons for 
excluding a ``non-covered business'' from the requirements of this 
rule. We cannot discount the possibility that some firms might form 
separate businesses to bring their disaggregated annual sales below the 
threshold for a non-covered business, but this is not likely to be a 
common occurrence and such separation may not be advantageous for 
business reasons. Therefore, we do not believe that the possibility 
poses a reasonable basis upon which to modify this provision of the 
rule.
    (Comment 65) Among comments that we received in support of the 
proposed exclusion for non-covered businesses, some support keeping the 
provision at its proposed threshold of $500,000 in total annual sales. 
Another comment supports lowering the annual revenues threshold to 
$10,000, while a few support increasing it to $1,000,000. One comment 
supports the exclusion, but suggests defining a non-covered business 
exclusively as one that employs fewer than 500 people, regardless of 
annual revenues. According to this comment, annual revenues can vary 
from firm to firm, depending on the food products involved, for 
example, the differences between the prices of commodity items and 
premium or gourmet items. This comment proposes using a threshold of 
$1,000,000, consistent with the highest threshold in the proposed 
preventive controls for human food rule, in the event we decline to 
define a non-covered business in terms of the number of people 
employed. Another comment supports an increase in the threshold without 
explicitly suggesting a new one. Finally, one comment supporting the 
exclusion provision asks us to explicitly state that it would extend to 
foreign firms engaged in food transportation activities.
    (Response 65) We explain our reason for retaining the exclusion of 
non-covered businesses from the requirements of this rule in our 
response to Comment 62. We are retaining the threshold for a non-
covered business as a total annual revenues based threshold at the 
$500,000 level as proposed; however, we are allowing for adjustment for 
inflation and for basing the calculated value on average annual 
revenues, calculated on a rolling basis, during the 3 preceding years. 
We estimate that removing firms below this threshold from coverage by 
the rule would result in about 5 percent of food shipments not being 
covered by this rule
    To define a non-covered business as one not exceeding $10,000 in 
total annual sales, as one comment suggests, would not be consistent 
with our stated purpose of extending comparable treatment to firms 
subject to this rule and similarly situated firms subject to the FSMA 
preventive controls rules. A $10,000 total annual sales limit 
corresponds to a business of much smaller size than one that could be a 
``qualified facility'' as defined in the preventive controls rules and 
such a threshold would likely result in 100 percent of food shipments 
being covered by the rule.
    We considered changing the total annual sales limit for a non-
covered business to $1,000,000, which would be consistent with the 
definition of very small business in the Human Food Preventive Controls 
rule (the Animal Food Preventive Controls rule defined very small 
business as less than $2,500,000), but chose not to do so because it 
would result in about 10 percent of food shipments not being covered by 
this rule. While selecting a value of $1,000,000 for this rule would be 
more consistent with the Preventive Controls rules, which we believe to 
be a desirable endpoint, the percentage of food shipment not covered by 
this rule at that threshold would be vastly different than the less 
than 0.6 percent of food not covered by the Preventive Controls rules. 
We weighed the cost to this category of small businesses against the 
risk of adulteration, and determined that excluding 5 percent of 
shipments from coverage by this rule was more appropriate, because it 
would expose less food to any potential risk arising from non-coverage 
by this rule.

[[Page 20119]]

    We decline to establish the threshold for a non-covered business in 
terms of fewer than 500 people employed, because that threshold is the 
basis of the definition of a ``small business'' under this rule, which 
is a covered business category.
    (Comment 66) One comment asks us to add an additional exclusion for 
food establishments that sell to qualified end users, as defined by the 
FSMA preventive controls rules, as a separate category within the 
definition of ``non-covered business,'' or as a separate exclusion, 
rather than requiring this category of businesses to undergo the waiver 
process provided for in this rule. The comment states that such an 
exclusion would follow FSMA's mandate for the preventive controls rules 
and produce safety rule to be flexible, and scale- and supply-chain 
appropriate. The comment states that this mandate includes content 
requirements for the preventive controls rules and the produce safety 
rule to provide sufficient flexibility to be practicable for all sizes 
and types of businesses and facilities, and to provide modified 
requirements for small and mid-sized farmers and facilities engaged 
primarily in selling food through direct-to-consumer supply chains.
    (Response 66) The Preventive Controls rules for human and animal 
food provide for modified requirements for qualified facilities. 
Qualified facilities are defined in those rules to mean a facility that 
is a very small business (i.e., averaging less than $1,000,000 of 
annual sales of human or animal food), or a facility to which both of 
the following apply: (1) The average annual monetary value of the food 
manufactured, processed, packed or held at such facility that is sold 
directly to qualified end-users exceeded the average annual monetary 
value of the food sold by such facility to all other purchasers; and 
(2) the average annual monetary value of all food sold was less than 
$500,000. A qualified end-user is defined to mean the consumer of the 
food or a restaurant or retail food establishment that: (1) Is located: 
(i) In the same State or the same Indian reservation as the qualified 
facility that sold the food to such restaurant or establishment; or 
(ii) not more than 275 miles from such facility; and (2) is purchasing 
the food for sale directly to consumers at such restaurant or retail 
food establishment. In sum, facilities that sell less than $1,000,000 
of food are subject only to the modified requirements of the Preventive 
Controls rules, whether or not those sales are to qualified end users.
    As explained in our response to previous comments, we have 
attempted to make consistent, to the extent possible, the size-based 
``exemption'' from this and the Preventive Controls rules. Because we 
did not ``exempt'' from the preventive controls rules (i.e., subject to 
only the modified requirements) all firms that make sales to qualified 
end users, as suggested by the commenter, we are similarly declining to 
do so here. As a practical matter, however, the $500,000 exemption 
provided for in this rule applies whether or not the sales are to 
qualified facilities, as does the $1,000,000 threshold in the 
Preventive Controls rules. We explain in the preceding comment response 
why we did not select a $1,000,000 threshold in this rule.
    Nevertheless, 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 retail food establishments 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. As we stated 
in section III.E., we intend to publish a waiver in the Federal 
Register addressing this class of persons prior to the compliance date 
of this final rule.
13. Person
    In the proposed rule we defined ``person'' to mean individuals, 
partnerships, corporations, and associations. We have deleted this 
definition from this final rule, however, because Sec.  1.904 of the 
rule clearly states that the definitions and interpretations of terms 
in section 201 of the FD&C Act are applicable to such terms when used 
in this rule. We did not receive any comments on our definition of the 
term ``person.''
14. Pest
    We proposed to define the term ``pest'' to mean any objectionable 
animals or insects including birds, rodents, flies, and larvae. We are 
finalizing this definition as proposed.
    (Comment 67) One comment states that, while the utmost care is 
taken to ensure that natural pests of tree fruit are eliminated during 
the packing process, the presence of naturally occurring plant pests in 
tree fruit is not an indication of contamination and, if found, should 
not be cause for concluding that the tree fruit is adulterated.
    (Response 67) There is no provision in this rule by which we would 
automatically regard the presence of naturally occurring plant pests in 
tree fruit as grounds for determining that the food is unsafe. We do 
not intend to establish a standard for the adulteration of tree fruit 
because of the presence of naturally occurring pests. As we discuss in 
response to Comment 89, we have revised the provisions of the proposed 
rule that incorporated the adulteration provisions of the FD&C Act in 
addressing transportation equipment and operations. As we explained, we 
did this to avoid misinterpretation of this rule and to clarify that 
this rule only requires that transportation operations, including the 
use of transportation vehicles and equipment, must be conducted under 
conditions and controls necessary to prevent the food from becoming 
unsafe, i.e., adulterated within the meaning of sections 402(a)(1), (2) 
and (4) of the FD&C Act.
15. Receiver
    We proposed to define ``receiver'' to mean any person who receives 
food after transportation, whether or not that person represents the 
final point of receipt of the food. We further clarified in the 
proposed definition that the receiver may also be a carrier or a 
shipper and that a receiver does not include an individual consumer or 
a person who holds food on behalf of an individual consumer and who is 
not also a party to the transaction and not in the business of 
distributing food. In the final rule, as explained in the discussion of 
Sec.  1.908(a)(1), we have added a general provision about the multiple 
roles that can be played by a single entity to replace the separate 
provisions we had included in the proposed definitions of ``carrier,'' 
``shipper'' and ``receiver.'' We have also removed the specificity 
about the consumer or someone acting on his or her behalf because it 
was inappropriate for a definition, but we affirm that these entities 
are not subject to this definition. We did not receive any comments on 
our proposed definition of ``receiver.''
16. Shelf Stable
    We proposed to define the term ``shelf stable'' to mean a food that 
can be stored under ambient temperature and humidity conditions and, if 
the package integrity is maintained, will not spoil or become unsafe 
throughout its storage life. Examples of shelf stable food include 
canned juices, vegetables, and meat, bottled water, and dry food items

[[Page 20120]]

such as rice, pasta, flour, sugar, and spices. We are removing this 
definition from the final rule because the proposed exclusion (in the 
definition of ``transportation operations'') of ``shelf stable food 
that is completely enclosed by a container'' has been changed to apply 
to ``food that is completely enclosed by a container except a food that 
requires temperature control.'' We made this revision in the definition 
of ``transportation operations'' because, as we have previously 
explained, we have narrowed the focus of this rule to adulteration 
linked to food safety.
    While some non-shelf-stable foods that are completely enclosed by a 
container and do not require temperature control for safety, e.g., 
pasteurized orange juice, may spoil and become unfit for consumption if 
temperature abused, such a food will not become unsafe. The 
adulteration of food in such a circumstance, due to spoilage, would 
have been subject to this rule as proposed. This is no longer the case, 
nonetheless, FDA has authority under existing adulteration provisions 
in section 402 of the FD&C Act to address such a circumstance. We are 
addressing comments that spoke to the proposed exclusion of shelf 
stable food from the transportation operations definition to better 
inform readers about the scope of foods that would fall within the 
broader exclusion in revised definition.
    (Comment 68) One comment states that we should clarify the 
definition of ``shelf stable food'' so that it clearly applies to all 
shelf stable foods, including food ingredients such as flavoring 
substances and compounded flavors. The comment states that our proposed 
definition for ``shelf stable foods'' may be construed too narrowly 
because the examples we provided in the proposed language imply that 
the ``shelf stable food'' definition applies only to finished food 
products like canned juice, canned vegetables, or bottled water. The 
commenter voiced the view that it is unclear from the proposed rule 
whether we intend for that list to be exhaustive or exclusive. The 
comment asks us to ensure that the definition clearly applies to all 
foods, including food ingredients that meet the ``shelf stable food'' 
definition. Another comment recommends that we include examples of 
animal food, such as packaged animal food, in the definition of shelf 
stable food.
    (Response 68) We agree with these comments and affirm that food 
``completely enclosed by a container,'' as expressed in the definition 
of ``transportation operations'' encompasses food ingredients as well 
as finished food products for humans and animals. We are not including 
examples of such foods because this category of food is extremely 
broad, making any such list limited relative to the whole, and we 
believe that the revised definition describes the types of foods 
encompassed by this exclusion in an understandable manner.
    (Comment 69) Some comments state that shippers and carriers need 
more clarity on which food shipments are shelf stable. One comment 
states that the proposed definition provides a broad description of 
what constitutes shelf stable food but does not contemplate the diverse 
characteristics of food items, such as shelf-lives, packaging, and 
handling requirements that shippers and carriers will need to consider 
when determining whether food is shelf stable. The comment, for 
example, asks: How long the shelf-life of an item must be before it is 
considered shelf stable; whether packaging susceptible to humidity or 
humidity abuse would be considered to be fully enclosed, i.e., whether 
we would question if packaging susceptible to humidity or humidity 
abuse is capable of maintaining package integrity; and whether we would 
consider food items subject to spoilage when frozen and thawed at room 
temperature to be shelf stable? Another comment asks us to affirm that 
boxes with flaps that are sealed by tape qualify as acceptable 
packaging under this definition. This comment also asks us to affirm 
that this definition does not only apply to food products bound for 
retail outlets, but would also apply to food being shipped from a 
supplier to a re-packer. Another comment states that we should require 
shippers or loaders to give carriers unambiguous notice when they are 
given shipments of food that are not shelf stable.
    (Response 69) The shipper of the food, who often is also its 
manufacturer, would be the person who would be expected to know whether 
a food falls within the scope of the exclusion from the definition of 
``transportation operations'' applicable to food completely enclosed by 
a container and that does not require temperature control for safety. 
We would expect that the shipper would take the steps required under 
this rule with respect to the transportation of any food that falls 
within the scope of this definition. This rule does not require the 
shipper to inform the carrier that a shipment of food is not subject to 
this rule because it is excluded from the scope of this definition.
    In addressing the other questions raised by these comments we can 
state: (1) The requirements applicable to any food subject to this rule 
apply during transportation to all receivers that are subject to this 
rule, not just food bound for retail outlets; (2) In general, we would 
consider boxes with flaps sealed by tape to be a container that 
completely encloses the food; (3) The transportation of frozen food is 
not subject to this rule. As we stated in the proposed rule for 
preventive controls for human food (78 FR 3646 at 3774), the 
temperature and time required for a frozen food to become unsafe if not 
maintained in the frozen state would result in significant quality 
issues for the food before posing any safety risk, and as we discuss 
elsewhere in this final rule, we have narrowed the focus of this rule 
to adulteration linked to food safety; (4) There are packages which 
physically separate food from its surrounding environment that, 
nonetheless, allow for oxygen and atmospheric moisture exchange (e.g., 
paper, cardboard) under reasonably anticipated storage conditions 
during transportation, and for which we would regard the food to be 
completely enclosed by a container because the container would protect 
the food from any contamination that could directly enter the food from 
the environment; and (5) If a shelf stable food's container is 
subjected to abusive storage conditions during transportation which may 
compromise its package integrity and allow moisture to enter the food, 
the food product is not within the scope of the ``transportation 
operations'' definition, however, we would make a case-by-case 
determination as to whether the food complies with the requirements of 
FD&C Act, particularly, section 402(a)(4) which states that ``a food 
shall be deemed to be 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.''
17. Shipper
    We proposed to define the term ``shipper'' to mean a person who 
initiates a shipment of food by motor vehicle or rail vehicle. We 
further clarified in the proposed definition that the shipper would be 
responsible for all functions assigned to a shipper in this subpart, 
even if they are performed by other persons, such as a person who only 
holds food and physically transfers it onto a vehicle arranged for by 
the shipper, and that a shipper may also be a carrier or a receiver if 
the shipper also performs those functions as defined in this subpart. 
We are finalizing a simplified definition of ``shipper'' to mean a 
person who arranges for the

[[Page 20121]]

transportation of a food by a carrier or multiple carriers 
sequentially. A ``shipper'' could be a manufacturer or a freight 
broker. In the final rule, as explained in the discussion of Sec.  
1.908(a)(1), we have added a general provision about the multiple roles 
that can be played by a single entity to replace the separate 
provisions we had included in the proposed definitions of ``carrier,'' 
``shipper'' and ``receiver''. We explain our consideration of comments 
and our reasons for revising the final definition in the responses to 
Comment 70.
    (Comment 70) Several comments oppose defining a shipper as the 
person who ``initiates'' transportation. One comment states that the 
term is unnecessarily broad and would create confusion about who is 
subject to the shipper requirements. Another comment states that the 
meaning of the proposed definition is unclear because shipments of food 
can be initiated by many different types of persons during the 
transportation process, such as manufacturers, distributors, brokers 
(parties who arrange for the transportation of food held by other 
parties), and retailers. Another comment states that the shipper 
definition should describe the person who performs an activity directly 
related to the transportation process.
    Several comments suggest changes to the proposed ``shipper'' 
definition. Some stated that the shipper should be the person who 
physically loads or orders the loading of a motor vehicle trailer or 
railcar. Some comments state that the shipper should be the 
manufacturer of the food because that person is most knowledgeable 
about all relevant factors concerning sanitary transportation of the 
food. One comment states that the shipper should be the person who 
decides to ship a food product and sets the transportation process in 
motion.
    Other comments state that the shipper should be the person who owns 
the food at the time of shipment. One of these comments notes that 
product owners can best meet the responsibilities assigned to a shipper 
under the proposed rule even when another party arranges for the 
transportation of the shipment. The comment states that it is common 
industry practice for owners of the product to provide third-party 
logistics providers with instructions for the conditions required for 
shipments. Several comments advocating these revisions state that their 
suggested changes would clarify which entities in the transportation 
chain must meet this rule's requirements for shippers.
    Other comments state that the shipper definition should not place 
shipper responsibilities on persons such as brokers because they lack 
knowledge about food safety and sanitary food transportation practices. 
One comment stated that third-party logistics providers, such as 
distribution centers, should not be subject to the shipper definition. 
The comment states that, although third-party logistics providers 
arrange for the transportation of food, they lack knowledge about food 
safety and rely on product owners to provide that information in 
establishing sanitary transportation conditions.
    One comment stated that brokers are nowhere near the location where 
a shipment of food is being loaded into a motor vehicle trailer or 
railcar and, therefore, it is impossible for them to carry out duties 
assigned to a shipper, such as visually inspecting a vehicle prior to 
loading. A related comment asserts that facilities that hold the food 
for which shipment is arranged by an offsite shipper should be 
responsible for proper storage, handling, and loading or unloading of 
the food in accordance with FDA and customer requirements. Another 
comment addressed concerns that under the proposed shipper definition, 
shipper responsibilities would fall upon receivers who purchase food 
under a FOB contract in which title to the food passes at the seller's 
location, even though the receiver would not be present at the time of 
loading, and therefore could not meet this rule's shipper requirements. 
The comment states that the entity that physically loads the goods, 
instead of the receiver, is in the best position to meet a shipper's 
obligations, such as maintaining written procedures and records, and 
inspecting vehicles and transportation equipment prior to loading.
    (Response 70) We agree that our proposed definition for a shipper, 
i.e., the person who ``initiates a shipment of food'' is not 
sufficiently clear to identify the person who would be subject to this 
definition because the term ``initiates'' is not sufficiently precise. 
In considering how to revise this definition, we note that under the 
proposed rule, the shipper would be responsible for functions involving 
communication with the carrier that take place before transportation 
occurs (proposed Sec.  1.908(b)(1) and (3)), and with functions 
involving the inspection of vehicles and transportation equipment that 
take place prior to loading (proposed Sec.  1.908(b)(2) and (4)).
    We first considered which person would be best suited to perform 
those functions, which involve specifying to the carrier all necessary 
sanitary requirements for the carrier's vehicle and transportation 
equipment to ensure that the vehicle is in appropriate sanitary 
condition, and specifying temperature control parameters to the carrier 
if the food requires temperature control during transportation. 
Inasmuch as these functions involve communicating important information 
to the carrier about operating conditions during transportation, we 
have determined that the appropriate person to perform these functions 
is the person who makes the transportation arrangements with the 
carrier because this person communicates directly with the carrier and 
can directly provide the carrier with the information required by this 
rule. While the owner or the manufacturer of the food, or the person 
who loads the food onto a vehicle, may possess this information, we do 
not regard these persons as best suited to bear responsibility for 
providing information to the carrier if neither of these persons 
actually makes the transportation arrangements with the carrier.
    We also considered whether a shipper would need to be knowledgeable 
about food safety and sanitary transportation practices to perform 
functions that involve communication with a carrier before 
transportation occurs. While we agree that persons such as brokers, who 
arrange for transportation of food held by other parties, likely do not 
possess the degree of knowledge about food safety that a food 
manufacturer would, we also agree that current industry practices 
demonstrate that these persons, e.g., brokers and other third-party 
logistics providers, obtain the vehicle preparation and sanitary 
transportation information, as needed, for example, from manufacturers, 
to provide to the carriers. Therefore, we do not regard brokers and 
other third-party logistics providers as inappropriate persons to 
perform the functions assigned to a shipper that take place before 
transportation occurs.
    We have determined, therefore, that the person who arranges for the 
transportation of food by a carrier is best suited to perform the 
functions of a shipper that take place before transportation occurs and 
that the person can be someone who only arranges for the transportation 
of food, for example, a broker, as long as they have, or obtain, the 
necessary food safety information. We have incorporated these 
provisions into the revised definition of the term ``shipper'' in Sec.  
1.904.
    We also considered the second function assigned to the shipper in 
our

[[Page 20122]]

proposed definition, i.e., those involving the inspection of vehicles 
and transportation equipment and confirming that the shipper's 
specifications have been met, e.g., for cleaning and pre-cooling, which 
take place before food is loaded onto a conveyance. We agree with 
comments that state that a shipper who is not on site at the time of 
loading cannot readily perform these functions, and we do not believe 
that it would be practical to require an offsite shipper to arrange for 
a representative of the shipper to be present to perform these 
inspections. We therefore agree with the comment that states that these 
functions can be readily performed by the person who loads vehicles or 
transportation equipment if that person is not the shipper, provided 
that this person also receives the specifications for vehicle 
preparation that the shipper provides to the carrier under Sec.  
1.908(b)(1) and (2), because that person is on site and would typically 
be associated with the facility in which the food is held prior to 
loading. Further, the person likely would be knowledgeable with respect 
to basic sanitation practices applicable to loading food into vehicles 
and equipment because of his responsibilities in operating the 
facility. We also note that facilities that are subject to our cGMP 
requirements already have similar responsibilities under 21 CFR 117.93. 
This provision requires that storage and transportation of food must be 
under conditions that will protect against allergen cross-contact and 
against biological, chemical (including radiological), and physical 
contamination of food, as well as against deterioration of the food and 
the container.
    Therefore, we have determined that the shipper should not be 
responsible for the functions that person would have been assigned 
under Sec.  1.908(b)(2) and (4) of the proposed rule involving 
inspection of vehicles and transportation equipment that take place 
prior to loading. We are defining an additional term, the ``loader'' as 
described previously in this section to designate the person who will 
be responsible for those functions under this rule under Sec.  
1.908(c), which has been redesignated in this final rule as 
``Requirements applicable to loaders engaged in transportation 
operations.''
18. Small Business
    We proposed to define the term ``small business'' to mean a 
business subject to Sec.  1.900(a) that employs fewer than 500 persons, 
except that for carriers by motor vehicle that are not also shippers 
and/or receivers, this term would mean a business subject to Sec.  
1.900(a) that has less than $25,500,000 in annual receipts. In the 
final rule, we have revised the threshold for motor vehicle carriers to 
$27,500,000, consistent with the recent change made by the Small 
Business Administration in the size based standard for trucking firms 
in 13 CFR part 122.201. We have revised this final rule to base the 
calculation for ``small business'' on ``full-time equivalent 
employees.'' We used the same approach to calculate full-time 
equivalent employees for the purpose of this rule as we used to 
calculate full-time equivalent employees in the preventive controls 
rules (e.g., see response to comment 140 in the preventive controls for 
human food final rule (80 FR 55908 at 55962), and also the discussion 
of the definition of a full-time equivalent employee in that final rule 
(80 FR 55908 at 55962)). In conjunction with this revision and as 
previously described, we have established a definition for ``full-time 
equivalent employee'' as a term used to represent the number of 
employees of a business entity for the purpose of determining whether 
the business qualifies as a small business for the purpose of 
establishing its compliance date. Therefore, we are modifying the 
definition of ``small business'' to use the term ``500 full-time 
equivalent employees'' rather than ``500 persons.''
    (Comment 71) One comment states that the proposed definition of a 
small business is overly broad and would unduly delay the timeframe for 
compliance with this rule for the majority of the carriers.
    (Response 71) We do not agree that our proposed definition is 
overly broad. As we explained in the proposed rule (79 FR 7006 at 
7014), our proposed definition for a small business was based upon the 
applicable size-based standards issued by the U.S. Small Business 
Administration (SBA) under 13 CFR part 121. We believe that allowing 
businesses that are formally classified ``small'' by the SBA additional 
time to come into compliance with the requirements of this rule is 
appropriate. We also believe that small businesses that are able to 
come into compliance before their compliance date would do so and use 
that fact for promotional purposes with prospective customer's, e.g., 
shippers, rather than delay compliance with this rule.
    (Comment 72) A comment stated that we should exempt Class II and 
Class III railroads (these classifications generally relate to short 
line and regional railroads respectively) with fewer than 400,000 labor 
hours from the requirements of this rule. The comment states that the 
400,000 labor hours standard has been used by DOT from time to time as 
the standard for exempting small railroad carriers from regulatory 
requirements. The comment states that railroads are extremely capital 
intensive as they pay for their right of way and, typically, small 
business railroads invest much of their revenue into ties and track 
structure, equipment maintenance and inspections. The comment further 
states that shifting the responsibility for the sanitation of railcars 
carrying food products to the small railroad will be burdensome because 
these entities currently do not clean or sanitize cars or maintain 
facilities for such operations. Further, the comment states that it is 
difficult for railroads to know the storage condition of railcars, and 
that they cannot be reasonably held accountable for the storage 
conditions of cars in many circumstances of use.
    (Response 72) As discussed in our response to Comment 53, we have 
revised the definition of the term ``carrier'' in this final rule, in 
part, because our proposed definition would have established 
requirements that railroad operators, typically, cannot meet. We stated 
that under the revised definition of the term ``carrier'' in this final 
rule, a railroad operator only bears responsibilities under this rule 
when it has agreed to do so in a written contract with the shipper. We 
believe that this revision addresses the concerns of this comment.
19. TCS Food
    We proposed to define the term ``time/temperature control for 
safety (TCS) food'' to mean a food that requires time/temperature 
control for safety to limit pathogenic microorganism growth or toxin 
formation. As we explained in our response to Comment 111, we have not 
retained this definition in the final rule. We, therefore, do not need 
to address comments that we received that suggest revisions or 
clarifications to the proposed definition.
20. Transportation
    We proposed to define ``transportation'' to mean any movement of 
food in commerce by motor vehicle or rail vehicle. We did not receive 
any comment on our proposed definition and are finalizing it as 
proposed.
21. Transportation Equipment
    We proposed to define the term ``transportation equipment'' to mean 
equipment used in food transportation operations, other than vehicles, 
for example, bulk and non-bulk containers, bins, totes, pallets, pumps, 
fittings,

[[Page 20123]]

hoses, gaskets, and loading and unloading systems. Transportation 
equipment also includes a railcar not attached to a locomotive or a 
trailer not attached to a tractor. We are finalizing this definition as 
proposed with the exception of the removal of the phrase ``other than 
vehicles,'' which we are removing for clarity and the internal 
consistency of the definition.
    (Comment 73) One comment asks us to revise the proposed definition 
of ``transportation equipment'' to clarify that it encompasses only 
such equipment exclusively associated with a transportation conveyance. 
The comment states that the proposed definition is overly broad, and 
could be interpreted to include structures and equipment normally 
associated with storage, load-out, and receiving procedures (such as 
loading bins, spouting and other equipment located within a shipper's 
or receiver's facility), and not strictly to equipment that directly 
facilitates transportation activities. The comment suggests that we use 
the following revised definition: ``Transportation equipment means 
equipment used in food transportation operations, other than vehicles, 
e.g., bulk and non-bulk containers, totes and pallets loaded onto 
transportation conveyances, and pumps, fittings, hoses, gaskets, 
loading systems and unloading systems that are integral and affixed to 
transportation conveyances.''
    (Response 73) We decline this request. The definition of 
``transportation equipment'' already specifies that such equipment is 
used in transportation operations. While some types of equipment used 
in food transportation, such as hopper bins, may also be constructed as 
part of a facility, as we state in our response to Comment 52, we would 
not consider a hopper bin, that is constructed as part of a facility 
and that is used for storage of materials (but not the movement of 
food), to be transportation equipment. Therefore, it would not be 
subject to this rule.
22. Transportation Operations
    We proposed to define the term ``transportation operations'' to 
mean all activities associated with food transportation that may affect 
the sanitary condition of food including cleaning, inspecting, 
maintaining, loading and unloading, and operating vehicles and 
transportation equipment. We further proposed that transportation 
operations do not include any activities associated with the 
transportation of shelf stable food that is completely enclosed by a 
container, compressed food gases, or live food animals and that all 
transportation activities involving raw agricultural commodities (RACs) 
that are performed by a farm are also excluded from the definition of 
the term ``transportation operations.'' We are finalizing the 
definition of ``transportation operations'' as proposed with some 
additions. As we discuss in section IV.C., concerning our proposed 
definition of ``shelf stable,'' which we have not retained in the final 
rule, we have amended the definition of ``transportation operations'' 
to specify that this term does not include activities associated with 
transport of a food completely enclosed by a container except a food 
that requires temperature control for safety. We have also added that 
transportation operations do not include activities associated with 
transport of food contact substances as defined in section 409(h)(6) of 
the FD&C Act, human food byproducts transported for use as animal food 
without further processing, or live food animals except molluscan 
shellfish. Finally, we have revised the exclusion for transportation 
activities performed by a farm to all transportation activities 
performed by a farm, not just those related to the transport of RACs. 
We explain our consideration of comments and our reasons for the 
revisions in our responses to the next 12 comments.
    (Comment 74) A few comments ask us to consider excluding, or 
granting a waiver for, the transportation of food additives and 
substances that are generally recognized as safe (GRAS), and their 
precursors, from the proposed requirements of this rule. One comment 
states that these substances always undergo further inspection, 
testing, and processing steps, which minimizes the possibility that 
they could render the food ingredient, or the food that the ingredient 
is eventually incorporated into, adulterated. One comment states that 
exemption or waiving is appropriate because the production and supply 
chain for these substances includes controls to prevent contamination 
during production, packaging and transport, and is often certified by 
third parties. One comment urges us to apply this rule's provisions for 
prior cargo disclosures, protections from allergen cross-contact, and 
recordkeeping to these substances. The comment expresses the view 
however that a shipper should be exempted from even these requirements 
if it can demonstrate that its food additives and GRAS substances have 
not been transported in containers that have come into contact with any 
of the seven major food allergens, either because these products are 
not comingled with other foods or because the carrier does not 
transport any other food items.
    (Response 74) We decline these requests. We acknowledge that food 
additives, GRAS substances, and their precursors may undergo further 
inspection, testing, and processing that minimizes the possibility that 
they could render food adulterated, or that they may be subject to 
controls and third-party certification that address protection of the 
substance during transportation. However, this is a broad group of 
substances with diverse packaging and transportation practices (e.g., 
bulk shipments), and it is likely that there are substances for which 
the controls included in this final rule are necessary to ensure 
sanitary transportation, depending upon the nature of the substance, 
the method used to transport it, and its intended use. Therefore, 
exempting or waiving food additives and GRAS substances and their 
precursors from the requirements of this rule would not be appropriate. 
However, we have added provisions to Sec.  1.908(a)(3) of this rule to 
provide sufficient flexibility to allow persons engaged in the 
transportation of these substances to use sanitary transportation 
practices that are appropriate for their circumstances.
    (Comment 75) One comment asks us to consider excluding shippers and 
carriers who transport byproducts from a processing facility, e.g., 
spent grain from alcoholic beverage production facilities, from this 
rule. The comment states that many industries have developed 
sustainable and cost-effective ways to use these byproducts as animal 
feed. The commenter believes that the new recordkeeping and inspection 
requirements proposed in this rule would hinder a beneficial practice 
that has worked successfully for many years.
    (Response 75) We have partially accommodated this request in this 
final rule by excluding from the definition of transportation 
operations, ``human food byproducts transported for use as animal food 
without further processing.'' The intent of this new language is to 
exclude from the definition human food byproducts that are not further 
processed into a manufactured animal feed. Most commonly, we expect 
that these byproducts move directly from the human food manufacturer to 
the farm, where they are fed directly to livestock, often by spreading 
on the ground. We do not intend to exclude from the definition of 
transportation operations human food byproducts that are transported to 
a business to be used as an ingredient in a manufactured animal food, 
or to be further processed in some

[[Page 20124]]

way (e.g., rendered) in the production of animal feed. We believe the 
scale of the public health risk posed by the former activity to be 
minimal, with the byproducts being transported to only one or several 
farms, while the scale of the public health risk posed by the latter 
would be substantially greater, with the byproducts being manufactured 
into large quantities of animal feed, possibly with a wide 
distribution. Our concern here is primarily with the potential for 
chemical contamination, as we are aware that many of the byproducts 
will be heat treated (e.g., rendered) in a way that will minimize the 
risk of microbiological contamination.
    With respect to transportation of human food byproducts for further 
processing into animal feed, we decline the request to remove such 
operations from the definition of transportation operations because we 
have determined that this final rule's recordkeeping and inspection 
requirements as applied to the transportation of such products are not 
burdensome and are appropriate for these types of transportation 
operations. The requirements we are establishing in this rule require 
that transportation operations be conducted so as to prevent food from 
becoming adulterated during transportation. We do not envision, for 
example, that carriers who transport spent grain materials to animal 
feed manufacturing facilities would have to clean or inspect their 
vehicles any more frequently under this final rule than what is already 
typically being done to facilitate safe transportation. However, if 
carriers haul intervening loads of fertilizer, for example, they would 
need to clean their vehicles before transporting spent grain intended 
for use as animal feed. In addition, as we explained in our response to 
Comment 149 and Comment 160, in Sec.  1.908(e)(4) and (e)(5) of this 
final rule, we have revised the proposed previous load and cleaning 
reporting requirements for bulk carriers in a manner that will reduce, 
and in some cases eliminate, recordkeeping requirements for these 
carriers.
    (Comment 76) Several comments support our proposed provision that 
would exclude the transport of live animals from the definition of 
``transportation operations.'' One comment disagrees with our tentative 
conclusion that sanitary transportation practices are not necessary to 
prevent live food animals from becoming adulterated during 
transportation and our proposal, therefore, to exclude their transport 
from the scope of this rule. This comment suggests that transportation 
during hot and cold weather, as well as long-distance transport, causes 
stress in the animals, resulting in increased shedding of pathogenic 
microorganisms in the manure of the animals being transported. The 
commenter asserts that these pathogenic microbes may be spread from one 
animal to another via physical contact in transportation vehicles, 
possibly resulting in a higher percentage of animals arriving at 
slaughter facilities with high levels of pathogenic microbes on their 
hides or feathers. The comment asserts that the more animals that 
arrive at slaughter with pathogens on their hides or feathers, the more 
likely that the mitigations applied by the slaughter facilities will be 
ineffective. The commenter further asserts that FSIS inspection at 
slaughter facilities is inadequate to mitigate this increase in risk 
and, therefore, asks us to require the cleaning of transportation 
vehicles with disinfectants between animal loads to mitigate the risk.
    (Response 76) We disagree with this comment. We recognize that the 
stress of transportation may increase the shedding of pathogenic 
bacteria in the manure of animals during transport, but we are not 
aware of scientific information that establishes that this leads 
directly to an increased level of pathogenic bacteria in food products 
originating from animals coming from FSIS-inspected slaughter 
facilities that could be controlled by establishing requirements 
through this rulemaking. The slaughter facilities handling the 
processing of these animals, as well as the regulatory agencies 
responsible for oversight of the facilities, such as the FSIS, are 
aware of these issues and the procedures they use to process these 
animals have been developed with this risk in mind. Slaughter 
operations at facilities subject to FSIS jurisdiction, for example, are 
already subject to requirements intended to minimize the risk of 
adulteration posed by the presence of contaminants on the external 
surfaces of live food animals.
    (Comment 77) One comment asks us to apply this rule's waiver 
provisions to determine whether to waive requirements for the transport 
of live food animals. The comment further asserts that we should use 
the waiver procedure, in part, to provide for an additional opportunity 
for public comment with respect to the risks that may be associated 
with the transportation of live food producing animals.
    (Response 77) We disagree. Section 416(d)(1)(A-B) of the FD&C Act 
provides us with the authority to waive any requirement of this rule 
with respect to any class of persons, vehicles, food, or nonfood 
products, if we determine that the waiver will not result in the 
transportation of food under conditions that would be unsafe for human 
or animal health, and will not be contrary to the public interest (21 
U.S.C. 350e(d)(1)(A-B)). As we discussed in the proposed rule (79 FR 
7006 at 7015), we are not aware of food safety concerns related to the 
transportation of live food animals intended for slaughter that could 
be addressed through this rule's sanitary transportation requirements. 
Furthermore, we also address specific concerns the commenter raised 
about this issue in our response to Comment 76, and explain why we have 
concluded that establishing requirements through this rulemaking to 
address those concerns is not necessary. The prerequisite condition for 
considering whether we should waive the requirements of this rule for 
the transportation of live food animals therefore does not exist, i.e., 
we are not aware of any concerns that would necessitate establishing 
sanitary transportation requirements applicable to live food animal 
transportation and, therefore, there are no requirements to waive. We, 
therefore, have recognized in our definition of ``transportation 
operations'' that the transportation of live food animals does not meet 
the criteria for inclusion in this definition.
    (Comment 78) One comment on our proposed definition of 
``transportation operations'' notes that the exclusion of live food 
animals from the definition possibly conflicts with our own guidance 
under the National Shellfish Sanitation Program (Ref. 26). It stated 
that some states, operating under FDA guidance, require temperature 
control during the transport of raw molluscan shellfish between the 
harvest area and the first receiver (also known as the ``dealer''). 
Participants made similar comments during the public meetings that we 
held on this proposed rule.
    (Response 78) We agree that temperature control is necessary to 
ensure the sanitary transportation of molluscan shellfish (e.g., 
oysters, clams, mussels) when transported live. As such, and to 
maintain consistency with guidance we have issued, we have revised the 
definition of ``transportation operations'' to state that molluscan 
shellfish are not included in the provision that otherwise excludes the 
transportation of live food animals from this definition.
    (Comment 79) Many comments support the exclusion of transportation 
activities for RACs performed by farms and voice the view that the 
exemption should be retained in our final rule. Several comments 
advocate for limiting

[[Page 20125]]

the exclusion only to RACs that will undergo further processing and a 
kill step before they are consumed. The comments argue that RACs 
covered by the produce safety rule will not be processed further before 
being consumed and therefore are particularly at-risk for becoming 
contaminated during transportation. Some comments oppose this exclusion 
provision. Some of these express the view that requirements for the 
same activity should not differ based on who performs the activity and 
argue that farm trucks transporting RACs should be covered under this 
rule. Another comment asks us to include a separate section in this 
rule that would apply to transportation activities for RACs performed 
by farms, and states that RACs transported by farms at a minimum should 
be subject to the rule's modification or revocation procedures 
applicable to waivers. One comment asks us to engage with industry and 
other key stakeholders, including trade associations, to establish a 
maximum distance that a farm exempt from this rule should be able to 
transport RACs.
    (Response 79) We are not aware of food safety concerns related to 
the transportation of RACs by farms that could be addressed through the 
sanitary transportation practices set forth in this rule, as we stated 
in the proposed rule (79 FR 7006 at 7016). We also stated in the 
proposed rule that we are not aware of instances in which insanitary 
conditions or practices, for example, improper temperature control, 
improper equipment construction, or inadequate equipment cleaning 
involving the transportation of RACs by farms have contributed to 
foodborne illnesses. We further stated that we recognize the diversity 
of farms and their transportation operations, including the size of the 
operation, the nature of the crop(s) being transported (e.g., large 
trailer loads of dry grain or livestock, small loads of fresh produce 
or shell eggs), the nature of existing transportation equipment (e.g., 
large tractor-trailers, small farm trucks and wagons), and the 
destination of the shipment (e.g., a local cooling facility, farmers 
market or restaurant, a more distant market), and the challenge that 
this diversity presents in developing a set of mandatory requirements 
that would be practical and broadly suitable for this sector. 
Therefore, we tentatively concluded that the sanitary transportation 
practices that would be required by this proposed rule are not 
necessary to prevent RACs from becoming adulterated during 
transportation by farms. We acknowledged that transportation from farm 
to market is often performed by independent carriers as arranged by 
shippers or receivers that are not farms. Similarly, farms may arrange 
for transportation (i.e., serve as a shipper) by a common carrier. 
Transportation by independent carriers, as compared to farms, is likely 
to be over long distances and to involve the use of much larger 
vehicles and transportation equipment that is generally more consistent 
with equipment used outside the farm sector. Furthermore, long distance 
transportation operations may involve several stops for dropping and 
picking up additional loads. Communication and coordination between 
carriers, shippers and receivers is a critical element in properly 
carrying out such transport where different parties are handling 
various transportation responsibilities, as opposed to transport 
performed by a farm where the farm is responsible for all of the roles 
covered by this rule except the receiver. To advance best practices for 
the transport of produce, the industry has developed guidance that 
addresses among other things, recommended practices for independent 
carriers (Ref. 27). Building on industry experience we have concluded 
that the requirements of this regulation should not apply to such 
carriers with regard to the transportation of food by farms. We did not 
receive any comments to the proposed rule that would cause us to alter 
our determination to provide this exclusion or that convince us that 
modifications or qualifying conditions should be added to the proposed 
exclusion for transportation of food by farms.
    Upon further consideration, we have also concluded that the 
exclusion from the transportation operations definition related to 
transportation activities performed by farms should not be limited to 
RACs. We are aware that farms ship and receive food items that are not 
RACs (e.g., feed received to sustain their livestock, value added 
packaged food, such as jams, honey, baked goods) and that these food 
items are transported in the same manner as described earlier in this 
document for RACs. We have concluded that the diverse handling of these 
non-RAC food items by farms presents the same challenge for developing 
a set of mandatory requirements that would be broadly suitable for this 
sector, as described earlier in this document for RACs. For this 
reason, we are removing the limiting clause ``for raw agricultural 
commodities'' from the exclusion of transportation activities performed 
by farms from the definition of transportation operations. Consistent 
with the preamble to the proposed rule, the exclusion is intended to 
apply to the activities of farms, regardless of whether the farm is 
serving in the role of shipper, loader, carrier, or receiver.
    Section 416(d)(1)(A) and (B) of the FD&C Act provides us with the 
authority to waive any requirement of this rule with respect to any 
class of persons, vehicles, food, or nonfood products, if we determine 
that the waiver will not result in the transportation of food under 
conditions that would be unsafe for human or animal health, and will 
not be contrary to the public interest. As we discussed in the proposed 
rule with respect to the transportation of RACs (79 FR 7006 at 7016), 
and are affirming herein, and as we discussed previously in this 
response with respect to other types of food transported by farms, we 
are not aware of food safety concerns related to transportation 
activities performed by farms that could be addressed through the 
sanitary transportation practices set forth in this rule. Accordingly, 
the prerequisite condition for considering whether we should waive the 
requirements of this rule for transportation activities performed by 
farms does not exist, i.e., we are not aware of any concerns that would 
necessitate establishing sanitary transportation requirements 
applicable to such transportation operations, and therefore there are 
no requirements for us to consider waiving.
    (Comment 80) One comment asserts that if transportation activities 
for RACs performed by a farm are excluded from this rule, we should 
clarify that a carrier would not be held responsible for any 
contamination that may have occurred before the RACs were loaded into 
the carrier's vehicle.
    (Response 80) Under this final rule, as revised, transportation 
activities for any food, including RACs, performed by farms, while not 
subject to the requirements of the rule, are still subject to the 
adulteration and other applicable provisions of the FD&C Act and our 
applicable implementing regulations. A farm that acts as a carrier, for 
example, that transports RACs and that is excluded from this rule, is 
still subject to section 402(a)(4) of the FD&C Act, which prohibits the 
holding of food under insanitary conditions whereby it may be rendered 
injurious to health or may become contaminated with filth.
    (Comment 81) One comment asks us to clarify whether fruit 
transported to a processing facility falls under the proposed exclusion 
for the transportation of RACs performed by a farm.

[[Page 20126]]

    (Response 81) Transportation activities for RACs, including fruit, 
to processing facilities are excluded from coverage under this rule, 
only if the activity is performed by a farm as defined in this rule. 
However, farms subject to the produce safety rule will be required to 
take steps to address the transportation of covered produce under that 
rule. Section 112.125 of the produce safety rule requires that 
equipment subject to that rule that is used to transport covered 
produce must be adequately clean before use in transporting covered 
produce and adequate for use in transporting covered produce.
    (Comment 82) One comment asks us to clarify whether this rule 
applies to dairy farmers who transport bulk animal feed in their own 
vehicles from a facility to their own farm. A second comment asks us to 
clarify whether almond hulls and shells are eligible for the rule's 
RACs transported by farms exemption.
    (Response 82) As we discuss in Comment 79, we have revised this 
final rule to provide that all transportation activities performed by a 
farm, and not solely those activities involving the transportation of 
RACs, are not subject to this rule.
    (Comment 83) Some comments ask us to clarify whether this rule 
applies to non-farm carriers who transport RACs on farms or from farms 
to processing facilities where additional sanitation procedures or 
microbial kill steps occur, for example, when fruit RACs are processed 
at the receiving facility into canned fruit. Some comments argue that 
RACs that are moved on a farm or from a farm to a processing facility 
should not be subject to the requirements of this rule, regardless of 
who owns and operates the vehicles and transportation equipment.
    (Response 83) Non-farm carriers, unless they are non-covered 
businesses, engaged in transportation operations, as defined by this 
rule for RACs, are subject to this rule regardless of whether the RACs 
are intended to be further processed. While the RACs in question may be 
further processed, there may be circumstances in which controls, for 
example, a specific vehicle cleaning procedure, are necessary to ensure 
that sanitary transportation practices are followed. We have added 
provisions to Sec.  1.908(a)(3) of this rule to provide sufficient 
flexibility to allow persons engaged in the transport of food intended 
for further processing to use sanitary transportation practices that 
are appropriate for their circumstances. The movement of RACs on a farm 
that have not entered commerce is not subject to this rule because such 
on-farm movement is not considered to be transportation, as defined in 
this rule.
    (Comment 84) One comment agrees that transportation of a shelf 
stable food that is completely enclosed by a container should be 
excluded from coverage under this rule, as we proposed. It states that, 
in addition, the exclusion should be extended to those same materials 
shipped in dedicated bulk containers, so long as the containers meet 
the criteria for sanitary food transportation.
    (Response 84) We wish to make it clear that this comment addresses 
transportation equipment and not vehicles. We agree with this comment 
provided that the shelf stable food as packaged within the equipment, 
i.e., the reusable dedicated bulk container, is completely enclosed by 
the container. As provided under the revised definition of 
``transportation operations,'' the described container, when used to 
transport any food that does not require temperature control for 
safety, meets the criteria for exclusion from the definition of 
``transportation operations.''
    (Comment 85) Several comments ask us to delete the word ``solely'' 
from the language in the definition of transportation operations 
excluding activities associated with the transportation of shelf stable 
foods from this definition. One comment states that the term ``solely'' 
is confusing and appears to suggest that shelf stable food should be 
shipped in separate loads apart from non[hyphen]food items and other 
covered food items.
    (Response 85) We agree that the word ``solely,'' as used in the 
proposed definition of ``transportation operations,'' may be confusing 
and we have concluded upon further consideration that it is not 
necessary. We, therefore, have removed the term ``solely'' from the 
definition of transportation operations.
23. Vehicle
    We proposed to define the term ``vehicle'' to mean a land 
conveyance that is motorized, i.e., a motor vehicle, or that moves on 
rails, i.e., a railcar, which is used in transportation operations. We 
are finalizing this definition as proposed.
    (Comment 86) One comment asserts that the definition of ``vehicle'' 
as any ``land conveyance that is motorized'' and the use of the term 
``motor vehicle'' are excessively broad and could be misinterpreted to 
include a wide range of motorized vehicles, including automobiles. The 
comment also notes that there are instances in which railcars, trucks, 
and trailers can be used to store food products. This comment asks us 
to narrow this definition to read: ``Vehicle means a truck or railcar, 
which is used in transportation operations and not to hold food.''
    (Response 86) We decline to make the suggested change. The 
definition of vehicle is intentionally broad and could include 
automobiles. We do agree that sometimes railcars, trucks, and trailers 
can be used to store food products, and we will incorporate that 
possibility into our implementation of this rule. A truck or trailer 
used for the permanent or semi-permanent storage of ingredients or 
finished food products is not within the scope of this rule and could 
be considered as part of a facility and regulated under another of our 
applicable regulations, e.g., the FSMA human or animal preventive 
controls rules that apply to the facility. A truck, trailer, or railcar 
being used, or being prepared for use, to transport human or animal 
food or food ingredients, would be subject to this rule. In either 
case, the equipment would need to be used in a manner consistent with 
the appropriate set of regulations, and in such a way that the food is 
not rendered unsafe.

D. What requirements apply to vehicles and transportation equipment? 
(Sec.  1.906)

    In table 7 we outline the revisions we have made to Sec.  1.906 in 
finalizing this rulemaking. Following the table we respond to comments 
about these provisions and describe the changes we have made to the 
provisions in finalizing the rule.

[[Page 20127]]



             Table 7--Sec.   1.906 What Requirements Apply to Vehicles and Transportation Equipment?
----------------------------------------------------------------------------------------------------------------
         Proposed section (Sec.   )                      Description                        Revision
----------------------------------------------------------------------------------------------------------------
1.906(a)....................................  Specifies that vehicles and       Removed the text that described
                                               transportation equipment must     the goal of the provision to be
                                               be designed and of such           prevention of food from
                                               material and workmanship to be    becoming ``filthy, putrid,
                                               suitable and adequately           decomposed or otherwise unfit
                                               cleanable for their intended      for food, or being rendered
                                               use to prevent food from          injurious to health from any
                                               becoming adulterated.             source'' from the regulatory
                                                                                 text because we have narrowed
                                                                                 the focus of this rule to
                                                                                 adulteration linked to food
                                                                                 safety. In the final rule, we
                                                                                 have replaced this text with
                                                                                 ``to prevent the food . . .
                                                                                 from becoming unsafe, i.e.,
                                                                                 adulterated within the meaning
                                                                                 of section 402(a)(1), (2), and
                                                                                 (4) of the FD&C Act.''
1.906(b)....................................  Specifies that vehicles and       Added ``for their intended use''
                                               transportation equipment must     to the regulatory text for
                                               be maintained in such sanitary    clarity.
                                               condition for their intended     Removed the text that described
                                               use to prevent food from          the goal of the provision to be
                                               becoming adulterated.             prevention of food from
                                                                                 becoming ``filthy, putrid,
                                                                                 decomposed or otherwise unfit
                                                                                 for food, or being rendered
                                                                                 injurious to health from any
                                                                                 source'' from the regulatory
                                                                                 text because we have narrowed
                                                                                 the focus of this rule to
                                                                                 adulteration linked to food
                                                                                 safety. In the final rule, we
                                                                                 have replaced this text with
                                                                                 ``to prevent the food . . .
                                                                                 from becoming unsafe.''
1.906(c)....................................  Specifies that vehicles and       Removed the phrases ``that can
                                               transportation equipment used     support the rapid growth of
                                               for food requiring temperature    undesirable microorganisms in
                                               control for safety must be        the absence of temperature
                                               designed, maintained and          control'' and ``maintain the
                                               equipped, as necessary, to        food under temperature
                                               provide adequate temperature      conditions that will prevent
                                               control to prevent the food       the rapid growth of undesirable
                                               from becoming adulterated.        microorganisms'' from the
                                                                                 regulatory text because our
                                                                                 goal with this provision is
                                                                                 prevention of adulteration
                                                                                 linked to food safety.
                                                                                Revised regulatory text to
                                                                                 specify that vehicles and
                                                                                 transportation equipment used
                                                                                 for food ``requiring
                                                                                 temperature control for safety
                                                                                 must be designed, maintained,
                                                                                 and equipped as necessary to
                                                                                 provide adequate temperature
                                                                                 control to prevent the food
                                                                                 from becoming unsafe.''
1.906(d)....................................  Specifies that freezers and       Removed this provision as
                                               mechanically refrigerated cold    unnecessarily prescriptive.
                                               storage compartments to be
                                               equipped with an indicating
                                               thermometer, temperature
                                               measuring device, or
                                               temperature recording device to
                                               show the temperature accurately
                                               with the compartment.
1.906(e)....................................  Specifies that vehicles and       As a consequence of eliminating
                                               transportation equipment must     former 1.906(d), this provision
                                               be stored in a manner that        is finalized as 1.906(d).
                                               prevents harborage of pests or   Removed the text that described
                                               becoming contaminated in any      the goal of the provision to be
                                               other manner that could result    prevention of food from
                                               in food becoming adulterated.     becoming ``filthy, putrid,
                                                                                 decomposed or otherwise unfit
                                                                                 for food, or being rendered
                                                                                 injurious to health from any
                                                                                 source'' from the regulatory
                                                                                 text because we have narrowed
                                                                                 the focus of this rule to
                                                                                 adulteration linked to food
                                                                                 safety. In the final rule, we
                                                                                 have replaced this text with
                                                                                 ``to prevent the food . . .
                                                                                 from becoming unsafe.''
----------------------------------------------------------------------------------------------------------------

1. Proposed Sec.  1.906(a)
    We proposed to require that vehicles and equipment used in 
transportation operations must be so designed and of such material and 
workmanship as to be suitable and adequately cleanable for their 
intended use, to prevent the food they transport from becoming filthy, 
putrid, decomposed or otherwise unfit for food, or being rendered 
injurious to health from any source during transportation operations. 
Consistent with a decision to more narrowly focus this rule on 
adulteration linked to food safety as explained in responses to 
comments below, we have finalized this provision to require that 
vehicles and equipment used in transportation operations must be so 
designed and of such material and workmanship as to be suitable and 
adequately cleanable for their intended use to prevent the food they 
transport from becoming unsafe, i.e., adulterated within the meaning of 
section 402(a)(1), (2), and (4) of the FD&C Act during transportation 
operations.
    (Comment 87) A comment from a non-profit organization that develops 
and updates equipment standards and processing practices asks us to 
include a provision in the final rule stating that vehicles and 
transportation equipment that have been fabricated in conformance with 
its standards and/or operated in accordance with its practices, and 
have been maintained in a sanitary manner, will be deemed to have met 
the minimum requirements of this rule.
    (Response 87) We are not making this suggested revision. It is the 
responsibility of the persons subject to this rule to determine whether 
the vehicles and transportation equipment that they use or offer for 
use in food transportation operations meet the requirements of this 
rule.
    (Comment 88) A few comments state that this regulation should not 
preclude

[[Page 20128]]

the use of food transportation vehicles and equipment constructed of 
wood, and ask us to clarify under what conditions we would deem the use 
of vehicles and equipment constructed of wood to be acceptable.
    (Response 88) Similar to statements we made in the produce safety 
rule (80 FR 74353) and final human food preventive controls regulation 
(80 FR 55908) about wooden bins, we are not precluding the use of 
transportation vehicles and equipment constructed of wood under this 
rule. However, where the intended use of the vehicle or equipment is 
such that food would be in direct contact with the wooden surface of 
transportation vehicles or equipment, we expect that such vehicles or 
equipment would be used only to the extent they are cleanable and 
unlikely to support conditions that may make the food unsafe (see 
Comment 95).
    (Comment 89) Several comments address provisions of this rule for 
transportation equipment used in operations involving food materials 
destined for animal consumption. One comment asserts that the 
provisions in proposed 1.906(a), (b), and (e), do not seem to consider 
the transportation of materials that are already in a condition not 
suitable for consumption without further processing, such as viscera, 
offal, and other byproducts from the chicken slaughtering process. The 
comment notes that firms transport these materials to facilities where 
they will be further processed and treated to recondition the materials 
to make them suitable for animal consumption. Although the 
transportation conveyances used to transport these materials to 
processing facilities may, in fact, allow the growth of microorganisms 
during transport, the subsequent treatment process accounts for this 
and effectively renders the materials suitable for animal consumption. 
A similar comment states requiring transportation conveyances for 
animal food to be free of ``filthy, putrid, or decomposed substances'' 
should not apply to unprocessed raw materials destined for rendering. 
These materials include offal and trimmings from animal slaughter, dead 
animals, and spoiled or outdated meat from retail food establishments. 
They are transported by renderers in specialized equipment to prevent 
leakage and spills, but requirements related to refrigeration, 
microbial contamination, decomposition, and adulteration during 
transportation are not germane to these raw materials destined for 
further processing and hazard control. Another comment asks us to 
revise the rule to state explicitly that vehicles and transportation 
equipment must be designed, maintained, and stored in appropriate 
sanitary condition ``for their intended use.'' According to this 
comment, doing so would clarify that different sanitary food 
transportation requirements can be applied to vehicles and 
transportation equipment, depending on the intended uses of the 
vehicles and equipment, while still making it clear that appropriate 
precautions must be followed in all circumstances. The commenter notes, 
for example, that although byproduct materials do not need to be 
transported under conditions that prevent them from becoming decomposed 
because they already are in this condition at the start of 
transportation, it would not be appropriate to transport these 
materials in a container that previously held a chemical contaminant 
that will not be eliminated through further processing if the container 
was not adequately cleaned before use.
    (Response 89) We agree that in the proposed rule, we applied 
language from section 402 of the FD&C Act identifying circumstances 
under which food is adulterated in an overly broad manner so as to 
suggest, unintentionally, that any food in transport that exhibits any 
cited criteria of section 402 is adulterated, regardless of the nature 
of the food or its intended use. We understand how a reader might 
interpret proposed Sec. Sec.  1.906 and 1.908 to mean that vehicles 
must be maintained and operated to always preclude food from becoming 
filthy, putrid, decomposed or otherwise unfit for food during 
transport, and that all food, including, for example, materials 
destined for rendering, that become filthy, putrid, decomposed or 
otherwise unfit for food as the result of transportation operations are 
adulterated. We, therefore, have revised Sec.  1.906(a), (b), and (d), 
and Sec.  1.908(a) to state that the relevant requirements for 
transportation vehicles, equipment and operations take the intended use 
of a vehicle or equipment into account and that the intent of these 
requirements is to prevent food from becoming unsafe, i.e., adulterated 
within the meaning of section 402(a)(1), (2), and (4) of the FD&C Act, 
during transportation. Therefore, we would not regard a transportation 
vehicle used to haul materials destined for rendering, e.g., viscera, 
offal, trimmings from slaughter operations, to be operating under 
insanitary conditions, given that the vehicle's intended use is to haul 
materials that will undergo further processing to make them suitable 
for animal consumption. We also would not regard rendering materials in 
transport to be adulterated for the same reason. However, we note that 
those engaged in transport of materials destined for rendering should 
consider whether previous cargo that could cause the material to be 
unsafe due to potential chemical contamination is a relevant 
consideration.
    We also recognize that provisions in Sec. Sec.  1.906 and 1.908 of 
the proposed rule that refer to the need, under certain circumstances, 
for temperature control of food during transport to prevent the ``rapid 
growth of undesirable microorganisms'' are used without appropriate 
consideration of the intended use of the food, e.g., it is intended to 
undergo further processing, and also suggest that any food in 
transportation in which undesirable microorganisms are present is 
adulterated. The proposed provisions further suggest that vehicles or 
transportation equipment that allow these conditions to prevail are 
insanitary for transportation purposes. We, therefore, have revised 
Sec. Sec.  1.906(c) and 1.908(a)(3)(iii) in this final rule to state 
that these requirements are applicable to food that requires 
temperature control for safety during transportation. Unless otherwise 
stated, we use the phrase ``food that requires temperature control for 
safety'' in this rule to mean that such temperature control is needed 
to prevent the food from becoming unsafe during transportation. 
Therefore, we would not regard an unrefrigerated transportation vehicle 
used to transport bulk materials destined for rendering to be in 
violation of this rule because the vehicle's intended use is to 
transport materials that do not require temperature control because 
they will undergo a subsequent heat processing treatment to destroy 
pathogens. We also would not regard rendering materials in transport, 
e.g., viscera, offal, trimmings from slaughter operations, to be 
adulterated for the same reason.
    As we discuss in our response to Comment 130, regarding revisions 
we have made to proposed Sec.  1.908(a)(3), we are also clarifying 
that, under this rule, the consideration of the type of food and its 
stage in the relevant production cycle are relevant in determining the 
necessary sanitary conditions and controls for any given transportation 
operation.
    (Comment 90) One comment asks us to exempt equipment used for 
transporting fruit and vegetable culls, for deposit into pastures as 
food for grazing animals, from the bulk vehicle requirements of this 
rule. It notes that Florida fresh citrus packinghouses often

[[Page 20129]]

load open-air dump trucks or dump trailers with culls for deposit onto 
the ground of local pastures. The cattle eating the culls are grazing 
animals and regularly feed from the ground. A similar comment asks us 
to exempt transportation operations that use certain classes of 
vehicles to transport raw and processed agricultural commodities, as 
well as feed and feed ingredients, from this rule at the outset to 
avoid a deluge of waiver petitions that this segment of the food 
transportation industry would otherwise submit to us for our 
consideration. This commenter singles out, for example, the use of 
shuttle trains and privately owned railcars that are dedicated 
exclusively to hauling grains and oilseeds as the types of 
transportation operations that it believes should be exempt from the 
rule. The comment also notes that animal feed and feed ingredient 
manufacturers often use their own dedicated truck fleets to haul large 
quantities of bulk and bagged products directly to farms and livestock 
and poultry operations. The commenter believes that these types of bulk 
vehicles and transportation equipment should be exempt from this rule 
because they pose limited risks for cross-contamination because SOPs 
for sequencing and cleaning-out these vehicles are already followed by 
these firms in order to comply with FDA's existing regulations for 
medicated animal feed.
    (Response 90) As we discuss in Comment 75, we have added a 
provision to this final rule excluding human food byproducts 
transported for use as animal food without further processing from 
coverage by this rule. Therefore, transportation operations for fruit 
and vegetable culls, for deposit into pastures as food for grazing 
animals, are not subject to this rule.
    We do not agree that the other types of vehicles described in these 
comments, or the transportation operations in which they are used, 
should be exempt from this rule. The requirements we are establishing 
for vehicles and transportation equipment, as we explained in our 
response to the previous comment, require that vehicles and 
transportation equipment be designed, maintained, and stored to prevent 
food from becoming adulterated during transportation under the 
vehicles' intended uses. These requirements are not burdensome and are 
appropriate even for vehicles used in operations where the risk of food 
adulteration is low.
    Finally, we note in response to the comment that bagged animal feed 
and bagged animal feed ingredients are exempt from this rule. These 
items fall outside of the scope of ``transportation operations'' (as 
defined in Sec.  1.904) that are subject to the rule because they are 
food completely enclosed by a container that does not require 
temperature control for safety.
    (Comment 91) A few comments ask us to address the appropriate 
sanitary conditions for the use of wood pallets. One comment observes 
that wood is a porous material and therefore is vulnerable to water 
absorption and potential contamination, but asserts that as long as the 
food is in appropriate containers and does not come into direct contact 
with wood pallet surfaces, the opportunity for contamination is slight. 
Another comment asserts that the pallet conditions that we described as 
being insanitary in the proposed rule are too restrictive for animal 
feed transport and allow an FDA inspector too much subjectivity in 
determining whether a pallet is fit for its intended use.
    (Response 91) Pallets need to be maintained so that they do not 
pose a risk of contaminating food during transportation or of 
compromising the integrity of the food containers that are supported by 
the pallet. For example, where the intended use of the pallet is such 
that food would be in direct contact with the wooden surface of the 
pallet, we expect that pallets would be used only to the extent they 
are cleanable and unlikely to support conditions that may make the food 
unsafe. (See Comment 88). In addition, pallets should not have jagged 
edges that protrude into the carrying surface in a way that could 
damage the product being shipped, e.g., wood splinters that could 
puncture food containers.
    (Comment 92) One comment asks us to amend the rule to allow 
railcars currently in use to remain in use until they are retired from 
service. The comment states that the absence of recent food safety 
incidents involving the rail transportation of food demonstrates that 
the design of railcars currently used in food transportation operations 
is adequate.
    (Response 92) There are no provisions in this rule that would 
require a railcar currently in use to be removed from service, as long 
as its condition permits the safe transport of food in accordance with 
established industry practices. If a railcar is in a condition not 
suitable for such use, we would expect that the railcar provider would 
take that car out of service for refurbishment or that the shipper 
would refuse to use the car if it is offered for food transport.
    (Comment 93) A few comments state that the term ``adequately 
cleanable'' used in proposed Sec.  1.906(a) is vague. One comment 
asserts that it fails to provide any discernable benefit to food 
transporters in preventing food contamination.
    (Response 93) As we state in our response to Comment 49, the term 
``adequate'' is a long-standing term that we defined in its current 
form when we first established cGMP requirements for the manufacturing, 
packing, and holding of human food. We are using the terms ``adequate'' 
and ``adequately cleanable'' to provide flexibility for shippers, 
loaders, carriers, and receivers to comply with the requirements of 
this rule in a way that is both effective for purposes of preventing 
the adulteration of food during transport and most suitable for their 
particular operations.
    (Comment 94) One comment states that we should recognize that not 
all transportation equipment needs to be cleaned before being used. The 
comment observes that cleaning wooden pallets can do more harm than 
good if proper precautions are not followed to prevent mold growth from 
moisture. The commenter notes that while it may be appropriate to 
expect water-based cleaning of certain types of transportation 
equipment, like hoses, for example, between every use, these kinds of 
cleaning practices should not be used for wooden pallets. The comment 
states that a visual inspection of pallets for cleanliness and 
suitability is sufficient to demonstrate that the pallets are 
acceptable for use and that the ``adequately cleanable'' standard for 
pallets should focus on the dry removal of debris like dust and dirt, 
when necessary.
    (Response 94) We agree that there are circumstances under which 
some transportation equipment would not need to be cleaned before each 
use and that pallets that are adequately clean for their intended use 
do not necessarily need to be cleaned after each use. However, when the 
cleaning of vehicles and transportation equipment is necessary for a 
transportation operation to meet the requirements of this rule, we 
would expect that appropriate cleaning practices will be followed. We 
address our principal concerns about the use of pallets in our response 
to Comment 91.
2. Proposed Sec.  1.906(b)
    We proposed to require that vehicles and transportation equipment 
be maintained in such a sanitary condition as to prevent the food they 
transport from becoming filthy, putrid, decomposed or otherwise unfit 
for food, or being rendered injurious to health from any source during 
transportation operations. Consistent with a decision to more narrowly 
focus this rule on

[[Page 20130]]

adulteration linked to food safety as explained in responses to 
comments below, we have finalized this provision to require that 
vehicles and transportation equipment must be maintained in such a 
sanitary condition for their intended use as to prevent the food they 
transport from becoming unsafe during transportation operations.
    (Comment 95) One comment states that this rule should explicitly 
distinguish between the terms ``sanitize'' and ``clean'' with respect 
to the intended use of the food being transported. The comment states 
that human food should be transported using equipment and vehicles that 
have been ``sanitized'' to prevent illness while a ``clean'' vessel is 
acceptable for the transport of animal feed.
    (Response 95) We did not define the terms ``sanitize'' or ``clean'' 
in the proposed rule and we decline the commenter's suggestion that we 
do so in this final rule. Section 1.906(b) states that vehicles and 
transportation equipment must be maintained in a ``sanitary 
condition.'' We do not consider ``sanitary condition'' to be synonymous 
with ``sanitize.'' We consider ``sanitary condition'' to be a state of 
cleanliness. The term ``sanitize'' is associated with the reduction of 
potentially harmful microorganisms. Section 1.906(b) further states 
that the requisite sanitary conditions of vehicles and transportation 
equipment are to be determined by the ``intended use'' of the vehicles 
and equipment in order ``to prevent the food they transport from 
becoming unsafe during transportation operations.'' Accordingly, as we 
state in our response to Comment 2, we recognize that the applicable 
sanitary transportation practices may vary depending on the types of 
food that are being transported. More stringent practices, for example, 
that might be necessary to ensure the sanitary transportation of one 
type of food, e.g., human food or pet food, might not be necessary to 
ensure the sanitary transportation of a different category of food, 
e.g., animal feed. Our response to Comment 2 discusses revisions we 
have made to Sec. Sec.  1.906 and 1.908 to clarify this point. However, 
whether the transportation operation involves human food or animal 
feed, the responsible persons under this rule must use all necessary 
sanitary transportation practices, given their circumstances, to 
prevent the food from becoming unsafe.
    (Comment 96) One comment states that proposed Sec.  1.906(b)'s 
requirement that vehicles and transportation equipment, such as hoses 
and pumps, be maintained in a ``sanitary'' condition is too ambiguous. 
The comment asks what it means for vehicles and equipment to be clean 
or sanitary, how we expect firms to meet this regulatory requirement, 
and what other types of transportation equipment we anticipate will be 
subject to this provision. The comment asserts that under certain 
circumstances, animal feed for livestock can still be protected from 
becoming unsafe even if the equipment used to transport it is not 
sanitary, clean, or washed out prior to shipment. The comment states, 
for example, that a firm can use dedicated equipment, product 
sequencing, and equipment flushing with water or another appropriate 
fluid followed by blowing the lines clear. Another comment states that 
railway hopper cars and semi-trailers used for transporting feed 
ingredients are not always dedicated to a single ingredient, but rather 
frequently are also used to haul RACs. This comment notes that, as a 
matter of current industry practice, cleaning between feed ingredient 
and RAC loads is minimal because there is an assumption that minor co-
mingling of different plant materials does not result in adulteration 
or otherwise present health hazards.
    (Response 96) We are requiring in Sec.  1.906(b) that vehicles and 
transportation equipment must be maintained in such a sanitary 
condition for their intended use as to prevent food from becoming 
unsafe during transportation operations. We are not prescribing, in 
this rule, methods (such as washouts) for the cleaning and maintenance 
of vehicles and equipment, nor are we establishing required intervals 
for cleaning operations. Firms may employ any cleaning procedures and 
intervals that meet the requirements of this rule.
    (Comment 97) One comment states that the term ``sanitary'' as used 
in proposed Sec.  1.906(b), and throughout the rule, is misleading 
because its general meaning infers a standard that exceeds the common 
understanding of the term ``clean.'' The comment states that 
transportation equipment and containers for animal feed for livestock 
do not need to be ``sanitary,'' but clean enough so as to prevent 
adulteration of the feed. The comment suggests that we delete the word 
``sanitary'' from the rule except when we refer to the transportation 
requirements for human or pet food.
    (Response 97) We decline to remove, or otherwise limit the use of, 
the word ``sanitary'' from this rule. We have not defined this term to 
mean ``beyond clean'' and our use of this term in the rule is not 
ambiguous. As we note in our response to Comment 95, we consider the 
term ``sanitary'' to be a state of cleanliness and we do not consider 
the term ``sanitary'' to mean that vehicles and transportation 
equipment necessarily must be ``sanitized'' to ensure that food is not 
rendered unsafe during transportation operations. We use the word 
``sanitary'' in Sec. Sec.  1.906 and 1.908 as it would apply to the 
conditions and controls employed for transportation operations, 
vehicles, and equipment to ensure that food will not be rendered unsafe 
during transportation. This is consistent with our responsibilities 
under section 7202 of the 2005 SFTA, which states that we shall, by 
regulation, 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 unsafe.
    Finally, as we also state in our response to Comment 2, we agree 
that this rule should more clearly recognize that sanitary 
transportation practices may differ depending on the types of food 
being transported, for example, human food versus animal food. Our 
response to that comment discusses revisions we have made to Sec. Sec.  
1.906 and 1.908 to clarify this point.
    (Comment 98) One comment asks us to acknowledge that polymerized 
oil residues that form on the interior steel surfaces of rail tanker 
cars during the repeated hauling of edible oils for processing into 
feed ingredients do not adulterate the oil. The comment notes that 
these residues only present food quality concerns and are removed by 
filtration and further processing.
    (Response 98) We agree. Residues that may form during edible oil 
transportation operations as described in the comment, which we would 
expect to be removed during further processing steps, are constituents 
of the oil which are not toxic by nature and do not make the food 
unsafe.
3. Proposed Sec.  1.906(c)
    We proposed to require that vehicles and transportation equipment 
that are used in transportation operations for food that can support 
the rapid growth of undesirable microorganisms in the absence of 
temperature control during transportation must be designed, maintained, 
and equipped, to maintain the food under temperature conditions that 
will prevent the rapid growth of undesirable microorganisms. Consistent 
with a decision to more narrowly focus this rule on adulteration linked 
to food safety and to add flexibility with regard to the approach to 
monitoring

[[Page 20131]]

temperature control as explained in responses to comments below, in 
this final rule we have revised proposed Sec.  1.906(c), with 
consideration of the provisions of proposed Sec.  1.906(d), such that 
final Sec.  1.906(c) requires that vehicles and transportation 
equipment used in transportation operations for food requiring 
temperature control for safety must be designed, maintained, and 
equipped, as necessary, to provide adequate temperature control to 
prevent the food from becoming unsafe during transportation operations.
    (Comment 99) Several comments ask that we acknowledge that means 
other than refrigerated vehicles can be used to keep food adequately 
cold during transport. These include the use of ice, dry ice, insulated 
coolers, and cooler totes. Another comment asks us to clarify that 
firms are not required to purchase cold foods from vendors with 
refrigerated vehicles, that is, the comment seeks clarification that 
firms can purchase cold foods from vendors who use means other than 
refrigerated vehicles for purposes of maintaining necessary temperature 
control of food products during transport.
    (Response 99) There is no requirement in this rule that foods 
subject to temperature control requirements must be transported in 
refrigerated vehicles or must be purchased from vendors with 
refrigerated vehicles. The use of the alternative methods described in 
this comment for keeping food cold during transport are acceptable 
under this rule if the vehicles, for example, catering trucks and 
commissary delivery vehicles, equipment, and transportation operations 
comply with the requirements of Sec. Sec.  1.906 and 1.908.
4. Proposed Sec.  1.906(d)
    We proposed to require that each freezer and mechanically 
refrigerated cold storage compartment in vehicles or equipment used in 
transportation operations for food that can support the rapid growth of 
microorganisms in the absence of temperature control during 
transportation must be equipped with an indicating thermometer, 
temperature measuring device, or temperature recording device to show 
the temperature accurately within the compartment. We have removed 
Sec.  1.906(d) as proposed from the rule.
    (Comment 100) A few comments address this proposed requirement. A 
participant at one of the public meetings we held on the proposed rule 
stated that we should require a temperature recording device for all 
transport vehicles that use refrigeration. One submitted comment states 
that it should not apply to a carrier if the shipper has provided its 
own device or relies on measures such as ice packs to maintain adequate 
temperature control. Another comment asks us to explicitly permit the 
use of hand-held temperature recording devices as an alternative to 
devices installed in or on a cold storage cooler. A few comments assert 
that low cost, time-temperature indicators are generally adequate for 
temperature monitoring purposes and that we should not require the use 
of expensive installed recording devices. A comment from the seafood 
industry states that ensuring continuous temperature control during the 
entire transit time requires the use of time-temperature recording 
devices (or the effective use of ice or other cooling media) and that 
indicating thermometers and temperature measuring devices are 
inadequate because they do not provide continuous documentation of 
temperature readings.
    (Response 100) We agree that there are a number of effective 
methods for monitoring temperature control during food transportation, 
some of which do not require the permanent installation of a device in 
the compartment. We reconsidered this proposed provision and have 
determined that persons subject to this rule should be able to use any 
effective means to monitor temperature control, such as those suggested 
by the comments, and that it is not necessary to retain this proposed 
requirement. Therefore, we have removed this provision from this final 
rule.
    (Comment 101) One comment also states that the proposed rule did 
not discuss the need for temperature indicating devices to be checked 
for accuracy and calibration.
    (Response 101) As we stated in our response to Comment 100, we have 
removed the requirement that vehicles and transportation equipment be 
equipped with a temperature indicating device from this final rule. 
Therefore, there is no need to establish temperature measuring 
equipment calibration requirements in this final rule.
5. Proposed Sec.  1.906(e)
    We proposed to require that vehicles and transportation equipment 
must be stored in a manner as to prevent the vehicles or transportation 
equipment from harboring pests or becoming contaminated in any other 
manner that could result in food for which they will be used becoming 
filthy, putrid, decomposed or otherwise unfit for food, or being 
rendered injurious to health from any source during transportation 
operations. Consistent with a decision to more narrowly focus this rule 
on adulteration linked to food safety as explained in responses to 
comments that follow (particularly see Comment 89), in this final rule 
we are requiring that vehicles and transportation equipment must be 
stored in a manner that prevents it from harboring pests or becoming 
contaminated in any other manner that could result in food for which it 
will be used becoming unsafe during transportation operations. In the 
final rule, this provision is redesignated Sec.  1.906(d) consistent 
with the removal of proposed Sec.  1.906(d).
    (Comment 102) One comment notes that some end-users store pallets 
used in transportation operations out-of-doors prior to use. The 
comment argues that end-users' pallet storage practices are just as, if 
not more, important for food safety than the programs and processes 
followed by pallet manufacturers and that pallets must be stored in an 
area with adequate light and airflow to prevent the formation of mold 
on the pallets.
    (Response 102) We have established requirements for the storage of 
transportation vehicles and equipment, including pallets, in Sec.  
1.906(d). The outdoor storage of pallets is permissible if the pallets 
meet the requirements of this section when they are used in 
transportation operations, i.e., they must be in such a condition that 
they will not cause the food that will be placed on them to become 
unsafe. When pallets are used to hold fully packaged foods, no or 
minimal cleaning may be necessary after outdoor storage. However, when 
they are used in such a way that ready to eat food comes into contact 
with the pallet, such as when they are used to hold some open mesh 
crates of produce, cleaning may be necessary after outdoor storage, 
especially if visible contaminants are present.
    (Comment 103) One comment states that railroad carriers shouldn't 
be responsible for how a railcar is stored at a third-party facility 
and asks us to clarify that the current industry practice of storing 
railcars on spur tracks and in rail yards is acceptable.
    (Response 103) We agree that the storage of railcars on spur tracks 
and in rail yards is acceptable if such storage meets the requirements 
of this rule (e.g., it does not become infested with rodents in such a 
way that subsequent cleaning will be ineffective). In most cases, empty 
railcars will be cleaned by or for the shipper after such storage, 
before use in holding food. However, if a railcar is stored in a manner 
that can lead to food that is subsequently loaded onto it becoming 
unsafe, that food may

[[Page 20132]]

be rendered adulterated. Determining who is responsible for such 
adulteration would be performed on a case-by-case basis, according to 
the specifics of the situation. As discussed in section IV.E.2., a 
shipper must develop and implement written procedures adequate to 
ensure that vehicles and equipment used in its transportation 
operations are in appropriate sanitary condition for the transportation 
of the food. These measures may be accomplished by the shipper or 
undertaken by the carrier or a third party.

E. What requirements apply to transportation operations? (Sec.  1.908)

    In table 8, we describe revisions to proposed Sec.  1.908 and 
following the table we respond to comments related to these provisions.

                   Table 8--Sec.   1.908 What Requirements Apply to Transportation Operations?
----------------------------------------------------------------------------------------------------------------
              Proposed section                           Description                        Revision
----------------------------------------------------------------------------------------------------------------
                  1.908(a)                    General Requirements
1.908(a)(1).................................  Requirements apply to all         Added ``loaders'' to the
                                               shippers, carriers, loaders,      provision and moved statement
                                               and receivers and a person may    out of individual definitions
                                               be subject to these               that a person could be, for
                                               requirements in multiple          example, both a shipper and a
                                               capacities.                       carrier.
1.908(a)(2).................................  Ensuring compliance with          No change.
                                               requirements must be assigned
                                               to competent supervisory
                                               personnel.
1.908(a)(3)(i)-(iii)........................  Transportation operations must    Replaced ``filthy, putrid,
                                               be conducted so as to prevent     decomposed or otherwise unfit
                                               food from becoming unsafe,        for food, or being rendered
                                               including taking measures such    injurious to health'' with
                                               as segregation, isolation, and    ``unsafe'' in 1.908(a)(3) and
                                               packaging to separate foods;      replaced description of ``food
                                               taking protective measures for    that can support the rapid
                                               food in bulk vehicles or not      growth of undesirable
                                               completely enclosed in a          microorganisms in the absence
                                               container from contamination      of temperature control'' with
                                               and cross contact; and ensuring   ``food that requires
                                               that food that requires           temperature control for
                                               temperature control for safety    safety'' in 1.908(a)(3)(iii).
                                               is transported under adequate
                                               temperature control.
1.908(a)(4).................................  Specify relevant factors (e.g.,   New provision.
                                               animal food vs. human food, raw
                                               material vs. finished food) in
                                               determining the necessary
                                               conditions and controls for the
                                               transportation operation.
1.908(a)(5).................................  Specify that shippers,            New provision.
                                               receivers, loaders and carriers
                                               which are under the ownership
                                               or operational control of a
                                               single legal entity, as an
                                               alternative to meeting the
                                               requirements of paragraphs (b),
                                               (d), and (e) of this section
                                               may conduct transportation
                                               operations in conformance with
                                               common, integrated, written
                                               procedures that ensure the
                                               sanitary transportation of food
                                               consistent with the
                                               requirements of this section.
1.908(a)(6).................................  If a covered entity becomes       New general requirement, which
                                               aware of an indication of a       was previously assigned to the
                                               possible material failure of      receiver in consultation with
                                               temperature control or other      the carrier and the shipper.
                                               conditions that may render the
                                               food unsafe 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.
                  1.908(b)                       Requirements applicable to
                                                           shippers
1.908(b)(1).................................  Requires that the shipper         Added ``loaders'' to the
                                               provide in writing to the         provision and the clause that a
                                               carrier and, when necessary,      shipper may take other measures
                                               the loader all necessary          in accordance with 1.908(b)(3).
                                               sanitary specifications for the   Added that a one-time
                                               carrier's vehicle and             notification of the sanitary
                                               transportation equipment to       specifications shall be
                                               prevent the food from becoming    sufficient unless the design
                                               unsafe. The shipper may take      requirements and cleaning
                                               other measures in accordance      procedures required for
                                               with 1.908(b)(3).                 sanitary transport change based
                                                                                 upon the type of food being
                                                                                 transported.
1.908(b)(2).................................  Shipper must specify in writing   Was proposed as 1.908(b)(3) and
                                               to the carrier, except a          required the shipper of a
                                               carrier who transports food in    ``Time/temperature control for
                                               a thermally insulated tank, and   safety'' (TCS) food to provide
                                               when necessary the loader an      information on the temperature
                                               operating temperature             conditions necessary for
                                               including, if necessary, the      transport in writing to the
                                               pre-cooling phase for a food      carrier to prevent the food
                                               requiring temperature control     from becoming filthy, putrid,
                                               for safety. Shipper may take      decomposed or otherwise unfit
                                               other measures in accordance      for food, or being injurious to
                                               with 1.908(b)(5) to ensure        health. The revised provision
                                               adequate temperature control.     focuses on the food safety
                                                                                 concerns with temperature
                                                                                 control.
1.908(b)(3).................................  Shipper must develop and          New provision.
                                               implement written procedures
                                               adequate to ensure that
                                               vehicles and equipment are in
                                               appropriate sanitary condition
                                               for the transport of food.
                                               Measures to implement the
                                               procedures may be done by the
                                               shipper or another party under
                                               the terms of a written
                                               agreement.
1.908(b)(4).................................  Shipper of food transported in    New provision.
                                               bulk must develop and implement
                                               written procedures adequate to
                                               ensure that a previous cargo
                                               does not make the food unsafe.
                                               Measures to implement the
                                               procedures may be done by the
                                               shipper or another party under
                                               the terms of a written
                                               agreement.

[[Page 20133]]

 
1.908(b)(5).................................  Shipper of food that requires     New provision.
                                               temperature control for safety
                                               must develop and implement
                                               written procedures to ensure
                                               the food is transported under
                                               adequate temperature control.
                                               Measures to implement the
                                               procedures may be done by the
                                               shipper or another party under
                                               the terms of a written
                                               agreement and must include
                                               measures equivalent to those
                                               specified for carriers under
                                               1.908(e)(1)-(3).
                  1.908(c)                       Requirements applicable to
                                                           loaders
1.908(c)(1).................................  Before loading food not           This new requirement for loaders
                                               completely enclosed by a          is similar to requirements that
                                               container, the loader must        were proposed for the shipper
                                               determine, based as appropriate   at proposed 1.908(b)(2), but
                                               on shipper specifications, that   the shipper may not be on site.
                                               the vehicle or transportation     Proposed 1.908(c)(1) was about
                                               equipment is in appropriate       access to handwashing
                                               sanitary condition (e.g.,         facilities and has been removed
                                               adequate physical condition,      from the rule.
                                               free of visible evidence of
                                               pest infestation, and previous
                                               cargo that could make the food
                                               unsafe).
1.908(c)(2).................................  Before loading food requiring     This new requirement for loaders
                                               temperature control for safety,   is similar to proposed
                                               the loader must verify,           1.908(c)(2), which required
                                               considering as appropriate the    shippers and receivers of food
                                               shipper specifications, that      that can support the rapid
                                               each mechanically refrigerated    growth of undesirable
                                               cold storage compartment or       microorganisms in the absence
                                               container is adequately           of temperature control to load
                                               prepared, including proper pre-   and unload under conditions
                                               cooling if necessary.             that would not support such
                                                                                 growth. This new loader
                                                                                 requirement is also similar to
                                                                                 proposed 1.908(b)(4) which
                                                                                 required shippers to verify
                                                                                 that each mechanically
                                                                                 refrigerated cold storage
                                                                                 compartment or freezer has been
                                                                                 properly pre-cooled.
1.908(d)....................................  Requirements applicable to        This provision specifically for
                                               receivers engaged in              receivers is new, resulting
                                               transportation operations.        from comments and our
                                              Upon receipt of a food requiring   understanding that receivers
                                               temperature control for safety,   would typically make a
                                               receivers must take steps to      determination that a shipment
                                               adequately assess that the food   may have been subject to
                                               was not subjected to              significant temperature abuse.
                                               significant temperature abuse,    Proposed 1.908(d) contained the
                                               such as determining the food's    provisions applicable to
                                               temperature, the ambient          carriers, which are finalized
                                               temperature of the vehicle, or    as 1.908(e) in this rule.
                                               smelling for off-odors.
                  1.908(e)                       Requirements applicable to
                                                           carriers
1.908(e)(1).................................  Per an agreement with the         Similar to proposed 1.908(d)(1)
                                               shipper that the carrier is       except ``filthy, putrid,
                                               responsible, the carrier must     decomposed or otherwise unfit
                                               ensure that vehicles and          for food, or being rendered
                                               equipment meet the shipper's      injurious to health'' has been
                                               specifications in accordance      replaced with ``unsafe'' per
                                               with 1.908(b)(1) is otherwise     our focus on adulteration
                                               appropriate to prevent the food   linked to food safety.
                                               from becoming unsafe.
1.908(e)(2).................................  Per an agreement with the         Similar to proposed 1.908(d)(2)
                                               shipper that the carrier is       which would have required the
                                               responsible, upon completion of   carrier to demonstrate to
                                               the transport and if requested    shippers and, if requested, to
                                               by the receiver, provide the      the receiver that temperature
                                               operating temperature specified   conditions were maintained
                                               by the shipper and, if            consistent with shipper
                                               requested by the shipper or       specifications. The revisions
                                               receiver, demonstrate that        in final 1.908(e)(2) are
                                               temperature conditions were       consistent with our new
                                               maintained during transport       provision in 1.908(d) that
                                               consistent with shipper           receivers take steps to
                                               specifications.                   adequately assess that the food
                                                                                 was not subjected to
                                                                                 significant temperature abuse.
1.908(e)(3).................................  Per an agreement with the         Similar to proposed 1.908(d)(3)
                                               shipper that the carrier is       except that the focus is on
                                               responsible, carriers must pre-   food requiring temperature
                                               cool each mechanically            control for safety rather than
                                               refrigerated cold storage         foods that support the rapid
                                               compartment as specified by the   growth of undesirable
                                               shipper before offering a         microorganisms, such as those
                                               vehicle for transport of food     that cause spoilage. The focus
                                               requiring temperature control     on food safety is also why the
                                               for safety.                       final provisions regarding pre-
                                                                                 cooling have eliminated
                                                                                 references to freezers, since
                                                                                 it is likely that there would
                                                                                 be significant quality defects
                                                                                 with time/temperature abused
                                                                                 frozen foods prior to the point
                                                                                 at which they would become
                                                                                 unsafe.
1.908(e)(4).................................  Per an agreement with the         Similar to proposed 1.908(d)(4),
                                               shipper that the carrier is       which would have required the
                                               responsible and if requested by   carrier to identify the three
                                               a shipper, a carrier that         previous cargoes. We realized
                                               offers a bulk vehicle must        that requiring provision of
                                               identify the previous cargo.      three previous cargoes was not
                                                                                 necessary for food safety and
                                                                                 we heard in comments that a
                                                                                 carrier may not have any
                                                                                 previous cargo information in
                                                                                 the normal course of its
                                                                                 business. Therefore, our final
                                                                                 provision specifies that this
                                                                                 information must be provided by
                                                                                 the carrier if it agrees to
                                                                                 provide the information.
                                                                                 Otherwise, the shipper is
                                                                                 responsible for considering the
                                                                                 sanitary requirements necessary
                                                                                 to prevent food from becoming
                                                                                 unsafe during transport.

[[Page 20134]]

 
1.908(e)(5).................................  Per an agreement with the         Similar to proposed 1.908(d)(5),
                                               shipper that the carrier is       which would have required the
                                               responsible and if requested by   carrier to describe the most
                                               a shipper, a carrier that         recent cleaning of the bulk
                                               offers a bulk vehicle must        vehicle to the shipper. We
                                               provide information that          heard in comments that a
                                               describes the most recent         carrier may not have any
                                               cleaning of the vehicle.          previous cleaning information
                                                                                 in the normal course of its
                                                                                 business. Therefore, our final
                                                                                 provision specifies that this
                                                                                 information must be provided by
                                                                                 the carrier if it agrees to
                                                                                 provide the information.
                                                                                 Otherwise, the shipper is
                                                                                 responsible for considering the
                                                                                 sanitary requirements necessary
                                                                                 to prevent food from becoming
                                                                                 unsafe during transport.
1.908(e)(6)(i)--(iii).......................  Carriers must develop and         No change from proposed
                                               implement written procedures      1.908(d)(6), except to change
                                               that (i) specify practices for    references to paragraph (d) to
                                               cleaning, sanitizing if           (e).
                                               necessary, and inspecting
                                               vehicles and transportation
                                               equipment to maintain them in
                                               appropriate sanitary condition,
                                               (ii) describe how it will
                                               comply with the temperature
                                               control requirements in
                                               1.908(e)(2), and (iii) describe
                                               how it will comply with the
                                               provisions for use of bulk
                                               vehicles in 1.908(d)(4) and
                                               (d)(5).
----------------------------------------------------------------------------------------------------------------

1. General Requirements (Proposed Sec.  1.908(a))
    We set forth in proposed Sec.  1.908(a) general provisions and 
requirements applicable to transportation operations.
    (Comment 104) We received many comments expressing concern that the 
proposed rule did not sufficiently recognize that practices for the 
transportation of raw materials may differ from those for finished food 
products, and that practices for the transportation of animal feed may 
differ from those used to transport pet food and finished human food.
    (Response 104) We agree with the comments and have added new Sec.  
1.908(a)(4) to make it clear that the type of food e.g., animal feed, 
pet food, human food, and its' production stage e.g., raw material, 
ingredient or finished food, are relevant to and must be considered in 
determining the necessary conditions and controls for transportation 
operations.
    (Comment 105) One comment expresses concern about the potential for 
cross contamination during the transportation of RACs. The comment 
states that the cross utilization of any equipment, including 
transportation vehicles, should be conducted in a manner that does not 
subject RACs to contamination and that equipment used to transport any 
food products that are minimally processed and consumed raw should be 
subject to sanitary requirements tailored to ensure the safety of the 
products.
    (Response 105) We agree that cross utilization of vehicles and 
equipment should not subject any food, including RACs, to cross 
contamination during transport. The provisions of Sec.  1.906 require 
the design, maintenance and storage of vehicles and transportation 
equipment, to be such that they will not cause food to become unsafe 
during transportation operations. In addition, Sec.  1.908(a)(3), which 
in part addresses the proper use of vehicles and equipment in 
transportation operations, requires that all transportation operations 
must be conducted under such conditions and controls necessary to 
prevent the food from becoming unsafe.
a. Proposed 1.908(a)(1)
    As previously discussed in the sections of this document related to 
the definitions of carrier, shippers and receivers, we have removed 
from these definitions the proposed sentence in each definition that 
stated that a party may serve in more than one capacity under this 
rule, e.g., a carrier may also be a receiver or a shipper, if the 
person also performs the functions of those respective persons. While 
we affirm that these statements are valid, we have consolidated them 
into a new sentence at Sec.  1.908(a)(1), which states that a person 
may be subject to these requirements in multiple capacities, e.g., the 
shipper may also be the loader and the carrier, if the person also 
performs the functions of those respective persons as defined in this 
subpart.
b. Proposed 1.908(a)(3)
    (Comment 106) One comment asserts that the requirements of this 
rule appear to duplicate warehousing and distribution requirements that 
appear in the FSMA preventive controls for human food rule, which 
require that food storage and transportation must be conducted under 
conditions that will protect against cross-contact and biological, 
chemical, physical, and radiological contamination of food, as well as 
against deterioration of the food and its container.
    (Response 106) The preventive controls rule for human food 
requirements in 21 CFR 117.93 provide broad good manufacturing practice 
(GMP) standards for warehousing and transportation-related activities 
that occur within the context of warehousing and distribution 
operations of facilities engaged in the manufacturing, packing, and 
holding of human food. This rule is intended to be complimentary to 
those and other provisions of the Preventive Controls rules for human 
and animal food and establishes more detailed requirements for 
shippers, loaders, receivers, and carriers to use sanitary 
transportation practices to ensure that food is transported under 
conditions that will prevent it from becoming unsafe. This is FDA's 
only rule that addresses the transportation of food in an integrated 
manner from beginning to end by establishing the interactions that must 
occur between shippers, loaders, carriers, and receivers to ensure that 
sanitary food transportation practices are used by the food industry. 
It is also the only rule to which carriers are directly subject. 
Accordingly, this rule is not redundant, as asserted by this comment, 
because it expands on the transportation-related requirements contained 
in the GMPs.
    (Comment 107) A few comments question the appropriateness of using 
the terms ``under such conditions and controls necessary to prevent the 
food from becoming . . . decomposed or otherwise unfit for food'' to 
describe requirements for transportation

[[Page 20135]]

operations. The comments state that fresh fruits and vegetables are 
perishable food products and therefore by their very nature eventually 
enter the senescence stage and begin to degrade (decompose) after they 
are harvested. The comments further state that such foods can be in 
this stage during transportation without yet becoming unfit for food. 
These comments assert that we are confusing the concepts of food safety 
and food quality by including these terms in this rule. The comments 
state that the terms should be removed and that the final rule should 
be strictly limited to ensuring the safe transportation of human and 
animal food.
    (Response 107) We acknowledge in our response to Comment 89 that we 
applied the language from section 402 of the FD&C Act in an overly 
broad manner in the proposed rule, so as to suggest, unintentionally, 
that any food in transport that is undergoing a natural process, i.e., 
senescense, is per se adulterated under this rule. As we also note in 
our response to Comment 89, we have revised Sec.  1.908(a) in this 
final rule to state that the intent of this provision is to prevent 
food from becoming unsafe. We would not regard perishable fruits and 
vegetables that are senescing during transport to be adulterated or 
unsafe.
    (Comment 108) One comment encourages us to ensure that time/
temperature control provisions of this final rule will complement 
related provisions contained in our seafood HACCP regulation.
    (Response 108) Our intent in drafting this final rule is to make it 
compatible with the seafood HACCP rule, which does not include 
requirements applicable to carriers. Under the seafood HACCP 
regulation, receivers are required to ensure that transportation was 
performed under appropriate temperature control, where such control is 
necessary for the safety of the food. To accomplish this, receivers of 
seafood often request temperature monitoring information from the 
carrier upon receipt. As we discuss in our response to Comment 129, 
this rule should assist receivers of seafood products by requiring 
that, upon their request, carriers must provide the operating 
temperature specified by the shipper and demonstrate that it has 
maintained temperature conditions during the transportation operation 
consistent with that operating temperature.
c. Proposed 1.908(a)(3)(i)
    We proposed to require that persons take effective measures, such 
as segregation or isolation, to prevent raw foods and nonfood items 
from contaminating other food products that might be shipped in the 
same load during transportation operations.
    (Comment 109) One comment addressing proposed Sec.  1.908(a)(3)(i) 
asserts that current industry practices ensure the adequate separation 
of ready-to-eat food items from raw foods and nonfood items through the 
use of packaging and impermeable barriers. The comment also states that 
our Food Code (Ref. 28) also considers packaging to be an adequate 
barrier for protecting food from contamination. Section 3-302.11 A. (4) 
of the Food Code states that ``[f]ood shall be protected from cross-
contamination by storing the food in packages, covered containers, or 
wrappings.'' The comment argues that because we acknowledged in the 
proposed rule that industry has developed practices that ``ensure that 
food is adequately protected from contamination by raw food items on 
the same load,'' there is no need to include the ``segregation and 
isolation'' language in this rule. The commenter further stated, 
however, that if we retain this language in the final rule, we should 
revise it to clarify that this provision should not be interpreted as 
requiring the complete isolation of raw foods from ready-to-eat foods 
during transportation.
    (Response 109) The 2005 SFTA mandates that we issue regulations to 
require that shippers, carriers, receivers and other persons engaged in 
the transportation of food use sanitary transportation practices to 
ensure that food does not become adulterated during transportation. We 
agree that both packaging, and segregation or isolation can be 
effective means of protecting food from contamination by raw foods or 
nonfood items in the same load. Therefore, we have revised proposed 
Sec.  1.908(a)(3)(i) to include packaging as one of the examples of 
such preventive measures during transportation operations.
d. Proposed 1.908(a)(3)(ii)
    We proposed to require that persons engaged in transportation 
operations take effective measures such as segregation, isolation, or 
other preventive measures such as hand washing, to protect food 
transported in bulk vehicles or food not completely enclosed by a 
container from contamination and cross-contact during transportation 
operations.
    (Comment 110) One comment addressing proposed Sec.  1.908(a)(3)(ii) 
asserts that persons who handle animal feed or raw feed ingredients 
without using gloves or washing their hands are not going to 
contaminate or adulterate food while engaged in loading, unloading, or 
transportation activities. The comment, therefore, asks us to exempt 
persons who handle animal feed from this provision.
    (Response 110) This provision does not require that persons who 
handle animal feed or raw feed ingredients always wear gloves and/or 
wash their hands. These measures are provided only as examples of steps 
persons may take to meet the requirements of this rule. As proposed, 
Sec.  1.908(a)(3)(ii) provides persons engaged in food transportation 
the flexibility to determine for themselves which measures are 
necessary to protect food transported in bulk vehicles or food not 
completely enclosed by a container from contamination and cross-contact 
during transportation operations. For this reason, we have not modified 
this section.
e. Proposed 1.908(a)(3)(iii)
    We proposed to require persons engaged in the transportation of 
food that can support the rapid growth of undesirable microorganisms in 
the absence of temperature control during transportation to follow 
transportation practices, including attention to temperature 
conditions, to prevent the food from becoming filthy, putrid, 
decomposed or otherwise unfit for food, or being rendered injurious to 
health from any source.
    (Comment 111) Several comments ask us to reconsider including 
temperature control requirements for non-TCS foods that require 
temperature control only for purposes of preventing spoilage and not 
for purposes of ensuring food safety.
    One comment states that because there are no potential safety 
hazards associated with such non-TCS foods, strict transportation 
temperature control requirements are not warranted. One comment 
observes that we proposed to exempt facilities that hold completely 
packaged refrigerated food from the requirements of the proposed FSMA 
preventive controls rule for human food, with the exception of 
facilities that hold TCS food. Under the preventive controls rule, 
facilities that hold such TCS food are only subject to preventive 
controls requirements to provide appropriate temperature control for 
such food. The comment asserts that we should not impose more stringent 
requirements on the transportation of food than we require for the 
holding of food under the preventive controls rule. The comment asserts 
that this rule, therefore, should not apply transportation requirements 
for temperature control to non-TCS foods that require temperature 
control

[[Page 20136]]

only for purposes of preventing spoilage.
    One comment acknowledges that the language of the 2005 SFTA is 
somewhat different from the language FSMA in that it directs us to 
issue regulations that are meant to ensure that food is not transported 
under conditions that may render the food adulterated. The comment 
further notes that adulteration is broadly defined by the FD&C Act and 
can encompass issues such as food spoilage in addition to the narrower 
issue of food safety. However, this comment states that such 
considerations are already addressed by the FD&C Act's adulteration 
provisions in section 402, and notes that FDA has the discretion to 
implement the provisions of the 2005 SFTA in a manner consistent with a 
risk-based framework focused more narrowly on food safety risks.
    Another comment states that while the temperature control 
provisions of this rule should not address non-TCS foods, it does not 
object to the inclusion of references in Sec.  1.906 to the prevention 
of the rapid growth of undesirable microorganisms (which would include 
microorganisms that cause spoilage) with respect to the design and 
maintenance of vehicles and transportation equipment, and in Sec.  
1.908 with respect to conditions for loading and unloading food, 
because these provisions do not relate to the maintenance of 
temperature control during transportation.
    (Response 111) We agree with the comments and explain in our 
response to Comment 89 that we have revised this rule to require 
temperature control only for foods that require temperature control for 
safety. Conversely, the temperature control requirements do not apply 
to food that is transported under temperature control for other 
reasons, for example, for marketability purposes, or to prevent 
spoilage of the food. In particular, we agree with the comment that 
stated that nonsafety considerations are already adequately addressed 
by the FD&C Act's adulteration provisions in section 402, and that we 
have the discretion to implement the provisions of the 2005 SFTA in a 
manner consistent with a risk-based framework focused more narrowly on 
food safety hazards.
    We also have reconsidered whether to define a descriptive category 
for the type of food (i.e., ``Time/Temperature Control for Safety (TCS) 
Food'') that would be subject to the temperature control provisions of 
this rule. We conclude that such a definition would serve no purpose 
because the revision we discuss in the preceding paragraph adequately 
designates the foods that would be subject to this rule's temperature 
control requirements. Therefore, we have removed the term ``Time/
Temperature Control for Safety (TCS) Food'' in the definitions section 
of this final rule in Sec.  1.904 and we have removed from this final 
rule the descriptive categories, ``TCS and non-TCS,'' which appeared in 
Sec.  1.908(b)(3) of the proposed rule.
    The temperature control requirements of this rule apply to any food 
that requires temperature control for safety during transport, and 
foods in the latter category, though not subject to the temperature 
control requirements of this rule, are still subject to the 
adulteration provisions and other applicable provisions of the FD&C Act 
and applicable implementing regulations.
    (Comment 112) One comment asks us to rewrite the temperature 
control provisions of this rule to clarify the requirements applicable 
to TCS and non-TCS foods. Other comments recommend that we establish 
temperatures for use by shippers in crafting instructions to be given 
to carriers, to prevent discrepancies in temperature control 
recommendations among shippers. Some comments also suggest that we 
should provide guidance to the transportation industry for temperature 
control that would include extensive lists of TCS and non-TCS foods. 
One of these comments states that clarifying temperature controlled 
food requirements and providing such guidance would have the added 
benefit of assisting regulators tasked with the responsibility of 
enforcing this rule. One comment asks us to establish a maximum 
transportation temperature of 45 degrees Fahrenheit for TCS foods.
    (Response 112) We decline these requests. As we explain in our 
response to the preceding comment, we have removed the term ``Time/
Temperature Control for Safety (TCS) Food'' from the definitions 
section of this final rule in Sec.  1.904, and we have removed from 
this final rule the descriptive categories ``TCS and non-TCS,'' which 
appeared in Sec.  1.908(b)(3) of the proposed rule. We have replaced 
the definition with the concept of ``foods that require refrigeration 
for safety.''
    Because of the vast diversity of human and animal food types, FDA 
does not have the resources to compile exhaustive lists of foods that 
require or do not require temperature control for refrigeration nor a 
list of the appropriate temperature controls for foods. Such a task is 
made even more daunting because similar foods produced by different 
manufacturers may have different temperature control requirements, 
because of differences in formulation. We expect shippers of food to be 
aware of whether the foods that they are shipping require refrigeration 
for safety, either because they are the manufacturer of the food or are 
otherwise knowledgeable about the food safety attributes of the food, 
or because they have obtained such information from the manufacturer or 
another knowledgeable person. The Preventive Controls rules for human 
and animal food require the manufacturer of a food to consider the 
transportation needs of foods that they manufacture when they develop 
their food safety plans.
    Furthermore, as we explain in our response to Comment 129, we are 
no longer requiring shippers to specify temperatures to carriers that 
would be regarded as critical limits for food safety purposes. In many 
circumstances, the shipper is required to specify an operating 
temperature to the carrier, and the food is not necessarily unsafe or 
otherwise adulterated if that temperature is exceeded during 
transportation. Operating temperatures are generally set to allow for 
refrigeration compartment temperature fluctuations due to normal 
activities such as defrosting and opening and closing doors. They also 
are often set to minimize product deterioration, which is usually a 
more restrictive requirement than food safety. Regulatory limits for 
operating temperatures would need to integrate all of these factors for 
the diversity of foods and operations on the market. We will consider 
establishing guidance in the future for operating temperatures for the 
transportation of foods that require temperature control, should the 
need arise.
    We disagree with the suggestion that we should establish a maximum 
transportation temperature of 45 degrees Fahrenheit for TCS foods. As 
we explain in our response to Comment 129, we have established 
requirements, as revised in this final rule, that would preclude the 
sale or distribution of any food that upon receipt presents an 
indication of a possible temperature control material failure during 
transport, unless it can be determined that the temperature deviation 
has not rendered the food unsafe. We conclude that this is an 
appropriate science-based approach to apply when assessing whether a 
potentially significant temperature deviation has occurred during 
transport because it provides for consideration of all significant 
factors, e.g., the ability of the specific food to support pathogens 
that are reasonably likely to be present in the food, and the duration 
of the temperature deviation, rather than simply whether a

[[Page 20137]]

temperature limit was exceeded. Furthermore, allowing a TCS food to be 
transported at temperatures up to 45 degrees Fahrenheit would not 
provide appropriate temperature control for some TCS foods, which may 
have to be transported at lower temperatures to ensure the safety of 
the food, e.g., some vacuum packaged fish.
    (Comment 113) We requested comment in the proposed rule regarding 
whether, unlike the proposed regulation, the final regulation should 
apply to the transportation by farms of TCS RACs, which require time/
temperature control for food safety purposes, e.g., raw seed sprouts. 
One comment offers the view that we should not include transportation 
by farms of TCS RACs in this regulation and that the industry's current 
best practices, which were not identified in the comment, sufficiently 
protect TCS RACs from adulteration during transportation.
    (Response 113) As we discuss in our response to Comment 111, we 
have removed the term ``Time/Temperature Control for Safety (TCS) 
Food'' from the definitions section of this final rule in Sec.  1.904, 
and we have removed from this final rule the descriptive categories 
``TCS and non-TCS,'' which appeared in Sec.  1.908(b)(3) of the 
proposed rule. Nonetheless, we received no comments that provided any 
information that changed our tentative conclusion to exclude from 
coverage TCS RACs when they are being transported by farms. 
Consequently, we have made no change in that regard. However, when such 
a RAC is being transported by a person other than a farm, it is subject 
to the applicable provisions of Sec. Sec.  1.906 and 1.908 of this rule 
that require transportation temperature control when it is necessary to 
prevent the food from becoming unsafe.
    (Comment 114) One comment asks us to acknowledge that fresh whole 
apples, pears, and cherries are transported under temperature control 
exclusively for quality purposes. The comment also asks us to 
acknowledge that we regard these fruits as being comparable to bananas, 
which we stated in the proposed rule are not subject to proposed Sec.  
1.908(a)(3)(iii) because there is no risk they will become adulterated 
if they are transported under conditions that are not temperature 
controlled. Another comment asks us to provide more examples of foods 
that would not be subject to proposed Sec.  1.908(a)(3)(iii), and 
suggests that these additional examples should include potatoes 
intended for processing into potato chips and chocolate and dairy based 
seasoning ingredients. The comment also asks us to train FDA inspectors 
to understand the circumstances under which foods would or would not 
require temperature control under this rule. Another comment asks us to 
exclude nuts, which are sometimes refrigerated during transport for 
quality purposes, from the scope of proposed Sec.  1.908(a)(3)(iii).
    (Response 114) This rule only requires temperature control during 
transportation when it is necessary to prevent the food from becoming 
unsafe. This rule does not establish requirements for the use of 
temperature control during food transportation for any other purpose, 
such as for marketability purposes, or to preclude the spoilage of food 
subject to this rule. We will ensure that our inspectors understand 
which factors generally distinguish foods that require temperature 
control to prevent the food from becoming unsafe from other foods that 
are transported under temperature control for quality purposes. As 
discussed earlier in this document, shippers are responsible for 
determining whether a food is subject to the temperature control 
provisions of this rule, because they require temperature control for 
safety. Whole, fresh apples, cherries, pears and potatoes are all 
examples of foods that generally do not require temperature control for 
safety. As we state in our response to Comment 112, we do not have the 
resources to provide an exhaustive list of foods that are transported 
under temperature control only for marketability purposes.
    (Comment 115) One comment asserts that the temperature control 
provisions of this rule do not apply to the transportation of refined 
fats and oils. The comment notes that the presence of temperature 
specifications in transportation documents such as bills of lading is 
related to quality and performance attributes of the refined fats or 
oils, and therefore should not serve as a basis for extending this 
rule's temperature control provisions to the transportation of refined 
fats and oils. The comment also notes that refined fats and oils are 
manufactured in closed systems and that the final product does not 
support the growth of undesirable microorganisms.
    (Response 115) We recognize that there may be occasions where 
temperature control is necessary for maintaining certain product 
attributes such as product quality, but not to prevent the food from 
becoming unsafe, as is the case, generally, for refined fats and oils. 
If temperature control is not required to prevent the food from 
becoming unsafe during transportation, the temperature control 
provisions of this rule do not apply to those transportation 
operations.
2. Requirements Applicable to Shippers Engaged in Transportation 
Operations (Proposed Sec.  1.908(b))
a. Proposed Sec.  1.908(b)(1)
    We proposed to require that the shipper must specify to the 
carrier, in writing, all necessary sanitary requirements for the 
carrier's vehicle and transportation equipment, including any specific 
design requirements and cleaning procedures to ensure that the vehicle 
is in appropriate sanitary condition for the transportation of the 
food, e.g., that will prevent the food from becoming filthy, putrid, 
decomposed or otherwise unfit for food, or being rendered injurious to 
health from any source during the transportation operation. The 
information submitted by the shipper to the carrier is subject to the 
records requirements in Sec.  1.912(a) of this rule.
    (Comment 116) One comment states that proposed Sec.  1.908(b)(1) 
should be revised so that it would apply only to requirements for the 
carrier's vehicle and transportation equipment that exceed the 
carrier's basic obligation to provide vehicles and transportation 
equipment that are clean, appropriate, and in safe condition for 
transportation of the food intended to be shipped.
    (Response 116) As we state in our response to Comment 119, we are 
aware that written information sharing between shippers and carriers 
currently is a routine part of the working relationship between these 
entities. We are retaining Sec.  1.908(b)(1) to ensure that all 
necessary requirements for the preparation of a vehicle or 
transportation equipment are communicated to carriers. However, this 
provision allows the shipper to use reasonable judgment in deciding 
what information must be communicated to a carrier to meet the 
requirements of this rule. We understand that a shipper could 
reasonably determine that it is not necessary to specify any procedures 
that are commonly understood by carriers such as those described by the 
comment.
    We have, however, modified this provision in several ways. First, 
because we have added a definition of loader, in response to comments 
that urged that we account for activities performed by the person 
loading a vehicle when that person is not also the shipper, receiver or 
carrier (see Comment 70). We recognize that there will be times when 
the shipper must provide instructions to the loader in addition to the 
carrier, e.g., instructions about any special sanitary

[[Page 20138]]

conditions to look for during the a preloading inspection. For this 
reason, we have included the loader as a person to whom the shipper 
must provide instructions about the sanitary specifications for the 
carrier's vehicle, when necessary. Second, we have changed the word 
``requirements'' to ``specifications'' in two places in this provision. 
We believe that this word better conveys the idea of conditions set out 
by the shipper to the carrier and loader, and is less likely to be 
confused with regulatory requirements of the rule. Third, we have 
changed the proposed phrase ``prevent the food from becoming filthy, 
putrid, decomposed or otherwise unfit for food, or being rendered 
injurious to health'' to ``prevent the food from becoming unsafe'' for 
consistency with our previously stated objective of focusing this final 
rule on food safety only. Finally, we have prefaced the requirement 
with the phrase, ``unless the shipper takes other measures in 
accordance with paragraph (b)(3) of this section, to ensure that 
vehicles and equipment used in its transportation operations are in 
appropriate sanitary condition for the transportation of the food.'' We 
have added this language in response to comments from the railroad 
industry (see Comment 53) that stated that they generally do not have a 
relationship with shippers whereby the shipper provides them with 
instructions relative to the sanitary condition of the railcar that 
they are to deliver. Our intent is that the language will establish the 
requirements of Sec.  1.908(b)(1) as the default arrangement whereby 
the shipper ensures that the vehicle and equipment meet appropriate 
sanitary conditions by providing instructions to the carrier and, when 
necessary, the loader, while also allowing for alternative arrangements 
(e.g., whereby the shipper personally ensures that the specifications 
are met), when that is consistent with the shipper's written SOPs, as 
provided for in Sec.  1.908(b)(3). We expect that many shippers that 
work with rail carriers will elect this latter approach, relieving them 
of the necessity to instruct the carrier about the necessary sanitary 
conditions for the railcar.
    (Comment 117) One comment states that while obtaining written 
specifications from a shipper about vehicle and equipment sanitation, 
cleanliness procedures, and temperature requirements is an industry 
best practice, it is not always feasible or practical. The comment 
asserts that there is no evidence to suggest that shipper 
specifications communicated verbally to the carrier instead of in 
writing create a higher food safety risk.
    (Response 117) We continue to assert that written specifications 
are consistent with industry best practice and are necessary to avoid 
confusion about the responsibilities of the various parties engaged in 
transportation operations. Such records are also valuable to assist FDA 
and other regulatory agencies in their verification role.
    (Comment 118) One comment singles out proposed Sec.  1.908(b)(1) as 
an example of a requirement for which we should afford firms 
flexibility and latitude to vary the content and level of detail 
contained in written specifications. The comment states that 
flexibility is needed, for example, to account for variations in the 
type of food type being transported, packaging, equipment, the 
transportation environment, and the shipper's experience with the 
carrier.
    (Response 118) We acknowledge that numerous, variable factors can 
affect the types of procedures that are required to prepare a vehicle 
or equipment to be offered to a shipper. For example, the nature of the 
previous cargo transported in a tanker truck might affect the type of 
cleaning procedure that would need to be followed to prepare the tanker 
truck for its next cargo. We would expect that these types of factors 
will affect the content and degree of detail contained in written 
specifications that shippers would provide to carriers and loaders 
under Sec.  1.908(b)(1). Nevertheless, the shipper must provide 
specifications to the carrier, and loader as necessary, that are 
adequate to enable them to ensure that the vehicle or transportation 
equipment is in appropriate sanitary condition for the transportation 
of the food, e.g., that will prevent the food from becoming unsafe 
during the transportation operation.
    (Comment 119) One comment asserts that the food transportation 
industry already has proven its ability to manage successfully 
information sharing between shippers and carriers through, for example, 
contractual agreements. The comment also asserts that proposed Sec.  
1.908(b)(1) will only add an additional, unnecessary layer of 
recordkeeping that will not add to the goal of feed safety, and that 
Sec.  1.908(b)(1) seems unnecessary, given that we require carriers to 
inspect transportation vehicles prior to loading. Finally, the comment 
states that we should provide clarification regarding how frequently 
information must be shared between shippers and carriers if we decide 
to retain this provision.
    (Response 119) As this comment observes, written information 
sharing between shippers and carriers engaged in food transportation 
already is a part of the routine working relationship between these 
entities. We do not envision that Sec.  1.908(b)(1) would require 
additional information sharing above and beyond that which routinely 
occurs and is necessary for purposes of enabling a carrier to offer a 
vehicle or transportation equipment in appropriate sanitary condition 
for the transportation of the food. Furthermore, the requirement in 
proposed Sec.  1.908(b)(2), that a vehicle or transportation equipment 
be inspected prior to loading prescribed cargoes, is a verification 
step that also reflects existing best practice and does not obviate the 
need for shippers to provide specifications to carriers that are 
adequate to enable a carrier to offer a vehicle or transportation 
equipment in appropriate sanitary condition for the transportation of 
the food. Therefore, we are retaining this requirement.
    However, as we note in our response to Comment 124, we have added 
language to Sec.  1.908(b)(1) stating that a one-time notification by a 
shipper to a carrier, and, when necessary, to a loader, shall be 
sufficient, unless there is a factor, e.g., the food or the conditions 
of shipment change, necessitating a change in the design requirements 
or cleaning procedures, in which case the shipper shall so notify the 
carrier and, as necessary, the loader in writing before the shipment.
    (Comment 120) A comment observes that a shipment may change hands 
many times during transit as it is transferred between carriers. The 
comment notes that in these instances, the shipper is not in contact 
with all of the subsequent carriers that may be involved and, 
therefore, would not be in a position to ensure its original 
requirements are met from start to finish. Therefore, the commenter 
argues that the original carrier, which has initial responsibility for 
ensuring that the food is handled in accordance with the shipper's 
requirements, should be responsible for transferring that 
responsibility to the next carrier down the line. The comment also 
states that, although an overseas shipper is in the best position to 
know the transportation conditions appropriate for a given food 
shipment when it is initiated, the shipment could change hands after it 
arrives in the United States and the sequential carriers, therefore, 
should bear responsibility for ensuring that the food is handled in 
accordance with the shipper's requirements.
    (Response 120) This rule would require that the shipper meet the 
requirements of Sec.  1.908(b)(1) for all

[[Page 20139]]

segments of a shipment's transit, no matter how many carriers might be 
involved in the transportation process. As we discuss in our response 
to Comment 70, those requirements have been established for the shipper 
based upon our determination that the person who arranges for the 
transportation of food by a carrier, i.e., the shipper, is best suited 
to perform these functions.
    (Comment 121) A comment addressing vehicle cleaning procedures 
states that with the exception of food-grade tanker trucks, there are 
no industry standards or protocols for cleaning and sanitizing vehicles 
that transport food. The comment opines that, other than general 
statements regarding the need to supply vehicles and transportation 
equipment that prevent food from becoming adulterated, the rule seems 
to allow shippers and carriers to agree upon the required cleaning 
practices. The comment also offers the view that the flexibility 
provided for by the rule may not be adequate, given the lack of any 
industry standards or vehicle and equipment cleaning best practices. 
Finally, the comment notes that if we elect to impose vehicle and 
equipment cleaning standards, we must recognize that there are a 
limited number of vehicle washout facilities available to the 
transportation industry, and that they vary in the type of services 
they are capable of providing.
    (Response 121) The commenter is correct that this rule provides 
flexibility to shippers and carriers to determine the appropriate 
protocols for cleaning transportation vehicles and equipment to comply 
with the requirements of this rule. In general, we do not expect that 
the requirements of this rule will necessitate a change in the 
procedures for vehicle and equipment cleaning. Nonetheless, Sec.  
1.908(b)(1) will require that these procedures be communicated to the 
carrier in writing. However, as we stated in response to Comment 116, 
this provision allows the shipper to use reasonable judgment in 
deciding what information must be communicated to a carrier to meet the 
requirements of this rule. We understand that a shipper could 
reasonably determine that it is not necessary to specify any procedures 
that are commonly understood by carriers, e.g., removal of dunnage, 
sweeping. To the extent that there is a need for guidance on cleaning 
procedures that go beyond those that are commonly understood, but not 
as extensive as those for bulk tankers (for which there is written 
industry best practice, as noted by the comment) we will consider 
issuing guidance or working with industry trade associations to develop 
written industry best practice on this subject.
    We are not establishing vehicle cleaning standards in this 
rulemaking. This rule provides flexibility to shippers and carriers to 
determine the appropriate protocols for cleaning transportation 
vehicles and equipment to comply with the requirements of this rule. We 
will consider issuing guidance on this subject in the future should the 
need arise.
    (Comment 122) One comment asserts that the proposed rule lacks 
sufficient flexibility to ensure that it can be implemented effectively 
by the food transportation industry. According to the comment, shippers 
are not always sufficiently knowledgeable to be able to specify ``all 
necessary sanitary requirements for the carrier's vehicle and 
transportation equipment.'' The comment also observes that shippers, 
carriers, and receivers typically work together to establish sanitary 
requirements that are appropriate for each particular type of food 
shipment.
    (Response 122) Persons responsible for complying with this rule may 
work with any other persons covered by this rule or third-party 
experts, for assistance in developing their specifications. For 
example, a shipper that is not the manufacturer may consult with the 
manufacturer or with a third-party expert.
    (Comment 123) One comment states that the design and construction 
of tanker trucks varies across the transportation industry and that 
variations can occur even within a given vehicle manufacturer's model 
lines. According to this comment, a preparatory procedure that is 
suitable and adequate for one tanker, therefore, may not necessarily be 
suitable and adequate for a differently designed or constructed tanker, 
and only an individual carrier has the best knowledge of the 
characteristics of its particular tanker.
    (Response 123) In order to prescribe the appropriate sanitary 
conditions for shipment of a bulk cargo, the shipper must have 
knowledge of the safety requirements of the food, as well as the 
construction of the vehicle and transportation equipment. We expect 
that the shipper will either have that knowledge based on prior 
training or experience, or will obtain information from someone with 
the necessary expertise. In the case of knowledge about the 
construction of tankers, it may well be that the shipper's best source 
of information will be from the carrier. An exchange of information 
between the carrier and the shipper, leading to a written specification 
from the shipper to the carrier, is fully consistent with the intent 
and language of Sec.  1.908(b)(1).
    (Comment 124) One comment asks us to confirm that a shipper's 
written communication required by proposed Sec.  1.908(b)(1) can be 
executed for a particular commodity for the duration of its agreement 
with each carrier rather than just for each particular product load. A 
second comment suggests that this requirement should specify that one-
time notifications will be sufficient unless the design requirements 
and cleaning procedures required by the shipper change because of 
changes in the types of food being transported, in which case the 
shipper would be required to supply the carrier with a new written 
notification.
    (Response 124) We agree with both commenters. Therefore we have 
added the language to Sec.  1.908(b)(1) in this final rule that states 
that one-time notification shall be sufficient unless a factor, e.g., 
the food or the conditions of shipment, changes, necessitating a change 
in the design requirements or cleaning procedures, in which case the 
shipper shall so notify the carrier, and, as necessary, the loader, in 
writing before the shipment.
b. Proposed Sec.  1.908(b)(2)
    We proposed to require that a shipper must visually inspect the 
vehicle or the transportation equipment provided by a carrier for 
cleanliness before loading food that is not completely enclosed by a 
container onto a vehicle or into transportation equipment provided by 
the carrier. We proposed that the shipper would have to determine that 
the vehicle or transportation equipment is in appropriate sanitary 
condition for the transport of the food, for example, that it is free 
of visible evidence of pest infestation and of debris, of previous 
cargo, or of dirt that could cause the food to become adulterated 
(revisions to the proposed provision are discussed in Comment 89). As 
we previously discuss in several sections of this document, 
responsibility for the pre-loading inspection no longer resides with 
the shipper, as we had initially proposed. Rather, in this final rule, 
the loader now bears this responsibility under Sec.  1.908(c)(1).
    (Comment 125) One comment states that proposed Sec.  1.908(b)(2) is 
inapplicable to bulk liquid tanker shipments because personnel do not 
enter the cavity of a tanker after it has been cleaned and made ready 
for loading. The comment recommends that we modify this requirement to 
make it goal-based by requiring the shipper to determine that the 
vehicle or transportation equipment is in sanitary

[[Page 20140]]

condition for the transport of the food by any appropriate means. The 
comment also asks us to provide examples of ways to accomplish this, 
for example, through the use of visual inspection, documentation, or 
cleaning.
    (Response 125) We agree that the pre-loading inspection requirement 
in this final rule should specify the inspection's objective without 
restricting it to a specific method, e.g., visual inspection. We have 
decided that the objective of pre-loading inspections should be a 
determination that the vehicle or equipment is in appropriate sanitary 
condition for the transport of food. At times, e.g., transportation of 
food that is not fully enclosed by a container, such an inspection 
would generally involve a visual inspection to ensure that the walls, 
floors, and ceiling of the vehicle are adequately clean, such that they 
are not likely to cause the food to become unsafe during 
transportation. However, at other times, e.g., bulk shipments in tanker 
trailers, the tanker trailer may already be washed and sealed before it 
arrives at the shipper's place of business, and the inspection may be 
as simple as checking for a wash ticket. We therefore have revised this 
provision in Sec.  1.908(c)(1) to state that the loader must determine 
through the pre-loading inspection process that the vehicle or 
transportation equipment is in appropriate sanitary condition for the 
transport of the food, e.g., it is in adequate physical condition, and 
free of visible evidence of pest infestation and previous cargo that 
could cause the food to become unsafe during transportation. We have 
also revised this provision to state that this inspection may be 
accomplished by any appropriate means.
    (Comment 126) One comment states that checking for the physical 
condition of a vehicle during the pre-load inspection, for example, 
checking for holes in the floor, walls and ceiling and the presence of 
off-odors and stains that might constitute residual evidence of a 
chemical spill or pooled water, is not specifically included in 
proposed Sec.  1.908(b)(2). The comment recommends that we expand the 
scope of the pre-loading inspection to include these items.
    (Response 126) We agree that in certain circumstances, e.g., 
transportation of food that is not fully enclosed by a container, the 
items discussed in the comment should be included in a pre-loading 
inspection. However, we are not specifying pre-loading inspection 
requirements in this rule because the nature of these inspections may 
vary from one type of operation to another depending on what would be 
necessary to determine that the vehicle or equipment is in acceptable 
sanitary condition for its intended use for the transportation of food. 
We have added the physical condition of the vehicle as an example of 
what may be included in a pre-loading inspection in Sec.  1.908(c)(1) 
of this final rule.
    (Comment 127) A comment states that, during the transport of animal 
feed, the carrier's driver often performs loading functions without 
having a shipper's employee present. The comment notes that this 
practice is established through contract stipulations between the 
shipper and carrier. The shipper may also choose to inspect the truck, 
depending on the feed to be loaded and customer requirements. The 
comment further states that, as a practical matter, a bulk trailer is 
often inspected after delivering a load to ensure that all the feed was 
delivered and that it is ready for loading the next load. The commenter 
asserts that this practice and verification of the last load delivered, 
in addition to contract requirements, sufficiently ensures the safety 
of the feed.
    (Response 127) This comment describes a situation where the carrier 
is also the loader. The practices described by the comment are 
consistent with the provisions of the final rule. In Sec.  1.908(c), 
this rule requires loaders, in this case also the carrier, to take 
actions before loading food not completely enclosed by a container onto 
a vehicle or into transportation equipment to determine that the 
vehicle or transportation equipment is in appropriate sanitary 
condition for the transport of the food. In this case, where a 
dedicated bulk truck is repeatedly used for the same cargo that does 
not require refrigeration for safety, e.g., animal feed, an inspection 
of the inside of the bulk vehicle after delivery of a load may be 
sufficient to ensure that it is in a suitable condition for loading the 
next shipment.
    (Comment 128) A few comments address proposed Sec.  1.908(b)(2) 
within the context of partial load shipments, which are also known as 
less-than-truckload (LTL) shipments. LTL shipments are those in which 
additional loads are subsequently added to a partially loaded truck. 
These comments state that the shipper of a partial load will likely be 
present only for the loading of its own shipment, but not for 
subsequent loads, and therefore cannot ``visually inspect the vehicle . 
. . for cleanliness'' or ensure ``that the vehicle . . . is in 
appropriate sanitary condition'' for subsequent loads. One of these 
comments states that the rule must also account for cross-docking 
situations in which cargo is transferred from the original vehicle to 
another vehicle or mode of transport. In cross-docking transfers, 
employees of neither the shipper nor receiver will be present during 
loading into the subsequent vehicle, and the subsequent vehicle may 
even be from another carrier.
    (Response 128) Under this final rule, the loader, and not the 
shipper or receiver, is responsible for performing the inspection upon 
loading as required by Sec.  1.908(c)(1). This requirement would apply 
to the loader for each sequential loading of a vehicle that makes 
multiple stops to pick up partial loads. This also applies to the 
loader for a trans-loading (cross docking) operation, as we discuss in 
our response to Comment 38.
c. Proposed Sec.  1.908(b)(3)
    We proposed to require that a shipper of food that can support the 
rapid growth of undesirable microorganisms in the absence of 
temperature control, whether a TCS food or a non-TCS food, must specify 
in writing to the carrier, except to a carrier who transports the food 
in a thermally insulated tank, the temperature conditions needed during 
the transportation operation, including the pre-cooling phase, to 
ensure that the carrier will maintain the proper temperature and meet 
the requirements of Sec.  1.908(a)(3). We also proposed to make this 
information subject to the records requirements in Sec.  1.912(a) of 
this rule.
    (Comment 129) A large number of comments oppose our proposed 
provisions in Sec.  1.908(b) and (d) for shippers and carriers engaged 
in the transportation of temperature controlled foods. These comments 
urge us to incorporate provisions into this rule that would allow for 
the continued use of existing food transportation industry best 
practices that have proven to be effective. They argued that management 
of temperature control for foods during transportation is a complex 
issue because it involves interactions between shippers, carriers and 
receivers who must address a variety of circumstances that may arise 
during the transportation of the food. We will first summarize the 
numerous comments we received on this matter.
     These comments universally oppose any requirement that 
carriers routinely demonstrate for each delivered load that they have 
met shipper temperature specifications. They state that confirming the 
functionality and settings of the refrigerator unit, or the temperature 
of the compartment upon loading and

[[Page 20141]]

upon receipt, and visually inspecting the food upon arrival for signs 
of temperature abuse is sufficient. The comments note, for example, 
that when a truck arrives at its destination, the receiver checks the 
trailer temperature setting. The receiver often also conducts a visual 
inspection to confirm that there are no visible signs of temperature 
abuse, such as sweating, the presence of ice crystals, signs of 
moisture, leaking products, moisture damage to packaging, or the loss 
of the structural integrity of packaging. According to these comments, 
checking the temperature of the food itself after transport has not 
been found to be necessary for purposes of ensuring food safety. The 
comments state that this is the case, in part, because if a 
refrigeration unit is turned off during shipment long enough to affect 
the temperature of the food product, a visual inspection of the food 
would be sufficient for purposes of determining whether a material 
temperature deviation that would have affected the safety of the load 
had occurred. The comments, therefore, assert that the current standard 
industry practice in most cases is to request temperature information 
about the load from the carrier upon delivery if there is a suspected 
food safety problem, for example, as indicated by a visual inspection.
     These comments also note that truck trailers often have 
devices onboard that can continuously record the refrigeration unit 
temperature that can be reviewed when necessary to investigate 
potential temperature deviations during transport that could affect 
food safety. These comments state, however, that this recorded 
information can be difficult to download and takes considerable time 
and expense to analyze because the process involves, among other 
things, identifying the container unit in transit, removing it from 
service, and delivering it to a facility capable of downloading the 
data. The comments further state that the cost of just extracting the 
data can be up to $200 per load and may require the services of a 
third-party vendor and that additional expense is incurred in analyzing 
the data. The comments therefore conclude that requiring the routine 
review of recorded onboard refrigerator temperature data is neither 
practical nor necessary.
     These comments also argue that the language of proposed 
Sec.  1.908(d)(2)(i) could be interpreted to require continuous 
temperature monitoring during food transport and suggest that we may be 
under the misimpression that the use of continuous monitoring devices 
is the norm in the refrigerated food transport industry. Some comments 
state that current best industry practices in many cases can give 
shippers confidence that appropriate temperatures are maintained during 
transit, without the use of continuous monitoring devices. One comment 
urges us to permit other forms of adequate temperature monitoring, such 
as documented alarm systems or properly documented manual temperature 
records. Many comments state that the rule should allow the carrier to 
use any means agreeable to the shipper to demonstrate the carrier's 
adherence to temperature specifications, such as recording trailer 
temperature settings when the vehicle is loaded and unloaded or 
periodic temperature checks during transit. Finally, some of the 
comments note that with the limited exception of the transportation of 
highly temperature-sensitive food products, such as vacuum packed 
seafood, where the shipper or receiver voluntarily may determine that 
the use of continuous monitoring devices is necessary to ensure product 
safety, using continuous temperature monitoring and recording devices 
is not necessary for purposes of ensuring the safety of the food during 
transport.
     These comments also state that a deviation from the 
shipper's temperature specifications does not necessarily cause the 
food to be unsafe. According to the comments, the temperature included 
in a shipment's bill of lading is the temperature at which the 
trailer's refrigerator unit needs to be set, but is often lower than 
the temperature needed to ensure the safety of the food shipment. A 
food that requires time/temperature control to ensure its safety (TCS 
food) and needs to be maintained at or below 40 degrees Fahrenheit, for 
example, may be transported during the winter in cold regions of the 
country at refrigerator settings very close to 40 degrees because this 
is adequate to ensure the temperature required for safety is not 
exceeded given the low outside air temperature. If, however, this food 
is transported during the summer, the shipper may direct the carrier to 
set the refrigerated trailer temperature much lower than 40 degrees 
Fahrenheit (e.g., 33 degrees Fahrenheit) because the warmer outside air 
temperature could cause the ambient temperature in the trailer to rise 
during transit. In this scenario, according to these commenters, the 
ambient temperature in the trailer upon arrival at the receiver's 
facility may be 36 degrees Fahrenheit, but this does not mean that the 
food is unsafe, even though the temperature is higher than what was 
indicated in the shipment's bill of lading. These comments conclude 
that for these reasons, this rule should clearly state that a deviation 
from the shipper's temperature specifications does not necessarily 
cause the food to be unsafe.
     Finally, these comments urge us to accord shippers the 
flexibility to assess the conditions under which the food was 
transported in determining whether temperature deviations cause the 
food to be unsafe. The commenters assert that, in many cases, the food 
may still be fit for its original intended use, notwithstanding any 
temperature deviations that might have occurred during transit. The 
comments also assert that in a case where a food may no longer be fit 
for its original intended use because of temperature deviations, the 
food may still be fit for an alternative use. A food product that may 
no longer be fit for its intended use as food for humans because of 
temperature deviations that might have occurred during transit, for 
example, might still be safe and fit for use as animal food. The 
comments argue that automatically deeming food adulterated because 
there was a temperature deviation during transit, without allowing for 
an evaluation of whether that deviation affected the safety of the 
food, would result in significant amounts of food waste without 
providing any corresponding food safety benefit.
    (Response 129) We agree that the provisions we proposed for persons 
engaged in the transportation of foods that require temperature control 
for safety should be revised to clearly focus their requirements on 
functions that ensure that adequate temperature control is provided, 
and to permit the continued use of established industry best practices 
that provide for the safe transportation of these foods. In revising 
these provisions, which are now designated as Sec.  1.908(b)(2) in this 
final rule, we considered the steps that occur before, during, and 
after the transportation of foods that require temperature control for 
safety to ensure the transportation operation is in accord with 
sanitary transportation practices. Our changes to this final rule 
involve revisions that affect the responsibilities of shippers (Sec.  
1.908(b)), loaders (Sec.  1.908(c)), receivers (Sec.  1.908(d)), and 
carriers (Sec.  1.908(e)).
    In revising this rule's provisions for foods that require 
temperature control for safety during transportation, we recognized the 
fact, expressed in several comments, that the temperature control 
measures we are establishing in this rule may not be necessary for some

[[Page 20142]]

transportation operations, e.g., those conducted during winter in cold 
areas or for short distance transportation of food in appropriate 
circumstances. As such, we are using in Sec.  1.908(b)(2), the phrase, 
``food that requires temperature control for safety under the 
conditions of shipment,'' to indicate that the requirements of this 
provision do not apply in situations in which the shipper determines 
that they are not necessary to ensure that the food does not become 
unsafe during transportation. We would expect that a shipper would be 
able to articulate the basis for any such determination if asked why 
temperature control is not necessary under the conditions of shipment.
    Under conditions of shipment where it is necessary to provide 
temperature control to ensure that food does not become unsafe during 
transportation, the shipper must provide written instructions to the 
carrier and, when necessary (e.g., if the shipper is not also the 
loader), to the loader, specifying temperature conditions to be 
maintained during transport.
    The comments we received clearly state that this provision, as 
proposed, may be interpreted to mean that we are requiring the shipper 
to specify a critical limit for the transport of the food, such that 
food held in a vehicle that exceeds the specified temperature may be 
unsafe and, therefore, adulterated. We recognize that under established 
industry practices, the temperature specification provided to a carrier 
is often lower than the temperature needed to ensure food safety and 
that if the ambient temperature in a trailer were to exceed the 
specified temperature, the food would not necessarily be unsafe. We 
agree with the comments that ask us to clarify that a deviation from 
the shipper's temperature specifications does not necessarily and 
automatically cause the food to be unsafe, and, therefore, adulterated. 
Therefore, we are revising this provision in Sec.  1.908(b)(2) to 
require that the shipper specify to the carrier, and, when necessary, 
to the loader, an operating temperature required for the given 
transportation operation, including, if necessary, the pre-cooling 
phase. We are adding a definition for the term ``operating 
temperature'' in Sec.  1.904 to state that this term means a 
temperature sufficient to ensure that under foreseeable circumstances 
of temperature variation during transport, e.g., seasonal conditions, 
refrigeration unit defrosting, multiple vehicle loading and unloading 
stops, the operation will meet the requirements of Sec.  1.908(a)(3). 
This revision clarifies that we do not intend for the temperature 
specified by the shipper to the carrier to be used as a critical limit, 
and that we understand that the specified temperature might be exceeded 
because of foreseeable circumstances that occur during transport, and 
that such deviations do not necessarily cause the food to become 
unsafe, and, therefore, adulterated.
    We next considered how this rule should address temperature 
monitoring during transportation and under what conditions data 
acquired during temperature monitoring should be communicated by a 
carrier to a receiver or shipper. The comments we received clearly 
state that under established industry practices, parties involved in 
food transportation use a wide variety of approaches for monitoring 
temperature conditions. In some instances, for example, the 
transportation of some vacuum packaged seafood products, the continuous 
monitoring of temperature during transportation is necessary to ensure 
that the food is maintained under safe conditions. In most other 
instances, the transportation industry relies primarily on means, other 
than reviewing temperature monitoring information acquired during 
transit, to establish that adequate temperature control was provided 
during transportation, e.g., vehicle temperature checks at loading and 
unloading, product temperature checks at receiving. In some instances, 
e.g., cross-country shipments, manual vehicle temperature checks may be 
made periodically during transit.
    We agree with comments that state that the proposed rule could be 
interpreted to require continuous temperature monitoring during 
transit, due in part to the proposed requirement at Sec.  
1.908(d)(2)(i) that a carrier must, once the transportation operation 
is complete, demonstrate to the shipper, and if requested, to the 
receiver, that it maintained temperature conditions during the 
transportation operation as specified by the shipper. We affirm that 
the carrier bears the responsibility for demonstrating, when necessary, 
that it transported food under appropriate temperature control 
conditions consistent with those specified by the shipper. However, we 
have revised this final rule at Sec.  1.908(e)(2) to allow that 
demonstration to be made by any appropriate means agreeable to the 
carrier and shipper, such as the carrier presenting recordings of the 
ambient temperature of a trailer when it was loaded and unloaded, or in 
the form of time/temperature data recorded during the shipment. This 
revision also clarifies that we are not requiring that the carrier 
conduct continuous monitoring of the temperature conditions on a 
vehicle during transport, but it also recognizes that in some 
circumstances it may be necessary to ensure the safety of the food and 
that, in these circumstances, the shipper and carrier may agree to this 
approach.
    We also considered circumstances in which it would be necessary for 
a carrier to provide information to the shipper about temperature 
conditions during shipment. We agree with comments that state that 
requiring a carrier to routinely demonstrate for each delivered load 
that it had met the shipper's temperature specifications is not 
necessary for purposes of ensuring food safety and is not consistent 
with current industry best practice. Therefore, we have revised this 
rule at Sec.  1.908(e)(2) to provide that the carrier's demonstration 
must be made only upon request by the shipper or the receiver. This 
revision clarifies that a carrier is not required to routinely provide 
this demonstration, but requires such a demonstration when, for 
example, as explained below, the receiver assesses the food upon 
receipt and determines that there may have been a material failure of 
temperature control during the shipment, or when the shipper and 
receiver have agreed that it is necessary to ensure the safety of the 
food (e.g., some shipments of vacuum packaged seafood).
    We also considered what measures, if any, should be required after 
a food transportation operation has been completed. Many of the 
comments that we received observe that receivers currently routinely 
check the function and settings of the transportation vehicle's 
refrigeration unit and conduct visual inspections of the delivered food 
products for which temperature control is required for signs of 
temperature abuse. We regard these types of inspections as essential 
for ensuring that the food was transported in accordance with 
appropriate sanitary transportation practices and was not rendered 
unsafe because of inadequate temperature control. Accordingly, we have 
revised this final rule in Sec.  1.908(d), which now includes 
requirements applicable to receivers, to provide that upon receipt of 
food that requires temperature control, a receiver must take steps to 
determine whether the food was subjected to significant temperature 
abuse. We also have provided examples of measures a receiver could 
employ for this purpose, such as determining the food product's 
temperature, the ambient temperature of the vehicle and its 
refrigeration unit's temperature settings and conducting a sensory 
inspection to

[[Page 20143]]

ascertain whether there are signs of temperature abuse, such as off-
odor. We also note that the receiver at this stage may review 
temperature monitoring information from an onboard temperature 
monitoring device that might have been employed during the food 
transportation process, and that such an approach would meet the 
requirements of this rule.
    We also added a provision to the general requirements of this rule 
Sec.  1.908(a)(6) that is applicable to circumstances in which 
temperature abuse of a food may have occurred or another event may have 
occurred that could have jeopardized the safety of the food (e.g., 
spillage of a toxic substance on food items in the same load). This 
provision states 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.
    This provision would, for example, require a receiver of food that 
requires temperature control for safety, that has performed a check of 
the vehicle compartment temperature as a way to comply with Sec.  
1.908(d), and determined that the temperature is above the operating 
temperature specified by the shipper, to hold the product until it can 
make a determination that the temperature deviation did not make the 
food unsafe. It could make that determination on its own, if it is 
qualified to do so, or could consult with the carrier, loader, shipper, 
or a third party to make such a determination or to assist it in making 
such a determination. Whomever makes such a determination should be 
qualified by training or experience to make such a determination, i.e., 
he should have a scientific understanding of how the temperature 
deviation could affect the growth of pathogens or production of toxins 
in the food. It is our expectation that, under such a circumstance, the 
receiver (or shipper, if that is the more appropriate party to make the 
determination) would request temperature control information from the 
carrier. The carrier would be obligated to provide that information to 
the shipper or receiver under the provisions of Sec.  1.908(e)(2).
    We have included in Sec.  1.908(a)(6) a provision that, if 
requested by the receiver, the carrier must provide to the receiver the 
operating temperature specified by the shipper in accordance with Sec.  
1.908(b)(2). This is a necessary exchange of information to facilitate 
the receiving examination provided for in Sec.  1.908(d), when the 
receiver may not be aware of the operating temperature that the shipper 
provided to the carrier.
    The new provision at Sec.  1.908(a)(6) would also, for example, 
require the carrier of a food that notices leakage of liquid from boxes 
of raw poultry onto partially enclosed crates of produce during a stop 
in transportation to hold the food until the carrier can obtain a 
determination from a qualified individual, e.g., the shipper, that the 
condition did not cause the food to be unsafe for its intended use.
    We agree with the comments that we received that argued that if a 
food has become unfit for its intended use because of material 
temperature abuse during transportation, the food may still be fit to 
an alternative use, such as for animal food. We would judge such 
circumstances on a case-by-case basis.
    We have further modified the provisions of proposed Sec.  
1.908(b)(3) (now Sec.  1.908(b)(2)) in several ways. First, because we 
have added a definition of loader, in response to comments that urged 
that we account for activities performed by the person loading a 
vehicle when that person is not also the shipper, receiver or carrier 
(see Comment 70), we recognize that there will be times when the 
shipper must provide instructions to the loader in addition to the 
carrier, e.g., instructions about pre-cooling conditions to look for 
during the a preloading inspection. For this reason, we have included 
the loader as a person to whom the shipper must provide instructions 
about the sanitary specifications for the carrier's vehicle, when 
necessary. Second, we have changed the proposed phrase ``food that can 
support the rapid growth of undesirable microorganisms in the absence 
of temperature control during transportation, whether a TCS food or a 
non-TCS food'' to ``food that requires temperature control for safety'' 
for consistency with our previously stated objective of focusing this 
final rule on food safety only.
    Finally, we have prefaced the requirement with the phrase, ``Unless 
the shipper takes other measures in accordance with paragraph (b)(5) of 
this section to ensure that adequate temperature control is provided 
during the transportation of food that requires temperature control for 
safety.'' We have added this language in response to comments from the 
railroad industry (see Comment 53) that stated that they generally do 
not have a relationship with shippers whereby the shipper provides them 
with instructions relative temperature control of the railcar that they 
are to deliver. Our intent is that the language will establish the 
requirements of Sec.  1.908(b)(1) as the default arrangement whereby 
the shipper ensures that the vehicle is operated during transportation 
at a temperature that prevents the food from becoming unsafe by 
providing instructions to the carrier and, when necessary, the loader, 
while also allowing for alternative arrangements (e.g., whereby the 
shipper personally ensures that the temperature conditions are met), 
when that is consistent with the shipper's written SOPs, as provided 
for in Sec.  1.908(b)(5). We expect that many shippers that work with 
rail carriers will elect this latter approach, relieving them of the 
necessity to instruct the carrier about the necessary temperature 
control conditions for the railcar.
    (Comment 130) Several comments state that the proposed temperature 
control requirements are excessive and inappropriate for the animal 
food industry, and ask us to revise and better align them with risk-
based practices that are commonly used in that industry. One comment 
states that refrigeration and temperature control are not relevant to 
rendering industry ingredients because the high-temperature cooking 
process of rendering destroys the pathogens contained in the raw 
materials. Another comment states that maintaining temperature 
conditions should only be considered when a firm has identified a 
hazard that needs to be controlled.
    (Response 130) We have revised Sec.  1.908(a)(3), as we discussed 
in our response to Comment 2, to clarify that the type of food 
involved, for example, animal feed, pet food, human food, and the 
food's given stage in the production process, for example, whether the 
food is a raw material, an ingredient, or a finished food product, must 
be considered when determining the conditions and controls, including 
temperature controls, that may be necessary to ensure the sanitary 
transportation of the food. We, therefore, agree that it would not be 
necessary to provide temperature control during the transportation of 
ingredients destined for rendering because these materials will 
eventually be treated with high heat to destroy pathogens. As we have 
previously stated, we have revised this final rule so that it focuses 
entirely on food safety issues. For this reason, control of temperature 
during transportation would not be required by the rule if

[[Page 20144]]

such control is not necessary to ensure its safety, e.g., where its 
only purpose is to minimize decomposition of the food.
    (Comment 131) Two comments observe that the proposed rule does not 
address the issue of how a shipment of food requiring temperature 
control, for which a material failure of temperature control during 
transport is suspected, should be handled. One of these comments 
expresses the view that that the rule should remain silent on this 
matter. The other comment argues that the issue is beyond the scope of 
this rule and the matter would be best resolved by a risk assessment to 
be conducted by the receiver and/or shipper.
    (Response 131) As we explained in our response to Comment 129, we 
have revised Sec.  1.908(a)(6) of this final 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.
    While we agree that it is unnecessary to prescribe the details of 
the mechanics of how such a determination is made, we do not agree that 
the actions of a receiver after taking delivery of a food shipment that 
may have been transported without appropriate temperature control, for 
example, are beyond the scope of this rule. We are charged under the 
2005 SFTA to establish sanitary transportation practices to be used by 
shippers, carriers by motor vehicle or rail vehicle, receivers and 
other persons engaged in the transportation of food to ensure that food 
is not transported under conditions that may render it adulterated.
    As we discussed in our response to Comment 129, we revised Sec.  
1.908(d) to establish duties for receivers of foods that require 
temperature control because we have determined that they are essential 
for ensuring that the food was transported in accordance with 
appropriate sanitary transportation practices, consistent with industry 
best practices. The new provisions at Sec.  1.908(a)(6) are an 
appropriate extension of the provisions at Sec.  1.908(a)(6), in that 
they ensure that the safety of the food is verified before a suspect 
food is moved further in commerce.
    (Comment 132) A comment asserts that if a shipper is shipping a TCS 
food product and holds it unrefrigerated on a dock before the food is 
loaded into a transportation vehicle, the temperature of the product 
will rise, which will increase the ambient temperature of the 
refrigerated trailer compartment after the food is loaded, perhaps 
causing a deviation from the shipper's temperature control 
specifications. The comment argues that this outcome is completely 
beyond the carrier's control and that it needs to be taken into account 
when monitoring the temperature of the transportation vehicle 
throughout the transport process.
    (Response 132) Under Sec.  1.908(a)(3)(iii), persons subject to 
this rule must ensure that food that requires temperature control to 
prevent it from becoming adulterated during transportation is 
transported under adequate temperature control. This requirement also 
applies to the holding of food on a loading dock. Responsibility for 
complying with this requirement resides with the loader and not with 
the carrier. Although this rule does not require the use of temperature 
controlled loading docks, it does require that the loader handle food 
that requires refrigeration for safety in such a way that will prevent 
it from becoming unsafe. This may be accomplished by a loader by, for 
example, rapidly moving the refrigerated product from its refrigerated 
storage to a precooled vehicle, or by temporarily holding the 
refrigerated product in a refrigerated loading dock prior to loading 
onto a precooled vehicle backed up to the loading dock.
    (Comment 133) Several comments ask us to clarify that the written 
temperature condition specifications that shippers must provide to 
carriers can appear in existing documents, such as contracts or bills 
of lading, and that they do not have to be conveyed by shippers to 
carriers in new, separate, dedicated documents.
    (Response 133) We agree. The shipper may meet the requirements of 
Sec.  1.908(b)(2) by communicating written information to the carrier 
in the form of existing contracts or bills of lading. Shippers do not 
need to create new, separate written temperature conditions 
specification documents for transmittal to carriers.
    (Comment 134) Some comments state that the proposed rule can be 
interpreted to require pre-cooling only when it is necessary to 
maintain temperature conditions during transport, and ask us to clarify 
this point. One comment, for example, states that pre-cooling may not 
be required for transportation during the winter in cold areas or for 
short distance transportation of food.
    (Response 134) We did not intend to suggest in the proposed rule 
that a shipper must always provide pre-cooling parameters to a carrier 
for the transportation of foods subject to the temperature control 
requirements of this rule. We agree that pre-cooling may not be 
required for transportation operations conducted during winter in cold 
areas or for short distance transportation of food in appropriate 
circumstances. Under this rule, the shipper must determine whether pre-
cooling a vehicle or transportation equipment by the carrier is 
necessary for the sanitary transportation of the food being shipped. We 
have revised Sec.  1.908(b)(2) to clarify this point by specifying that 
the shipper must provide pre-cooling specifications to the carrier and 
when necessary, to the loader (e.g., if the shipper is not also the 
loader), only if the shipper deems this step to be necessary to ensure 
that the transportation operation will be conducted under such 
conditions and controls necessary to prevent the food from becoming 
unsafe.
    (Comment 135) One comment states that pre-cooling transportation 
equipment is inadequate without pre-cooling the product. The comment 
singles out RACs as an example, noting that if the RACs are not 
adequately pre-cooled prior to transportation, they will cause the 
temperature of the pre-cooled carrier container to rise above the 
specified temperature limits, thereby potentially creating conditions 
for bacterial growth. Another comment asks us to modify the language of 
this rule to clarify that it does not prevent the loading of harvested 
RACs directly from the field into pre-cooled trailers provided by 
carriers. This comment states that although under these circumstances, 
the temperature in the trailer will increase after is has been loaded, 
this is still a beneficial practice because it begins decreasing the 
field heat of RACs as soon as possible. The commenter asks us to allow 
this practice to continue even though it may not be possible for a 
carrier operating under these circumstances to meet the proposed 
requirement that the carrier follow the shipper's temperature controls.
    (Response 135) Under Sec.  1.908(a)(3) of this rule, all 
transportation operations must be conducted under such conditions and 
controls necessary to prevent the food from becoming unsafe. In 
addition, it is the shipper's responsibility under Sec.  1.908(b)(2) 
(revised from proposed Sec.  1.908(b)(3)) to specify to the carrier 
and, when necessary, the loader, whether pre-cooling a vehicle or 
transportation

[[Page 20145]]

equipment is necessary for purposes of compliance with this rule. We 
have added the term ``if necessary'' to the pre-cooling provision of 
Sec.  1.908(b)(2) to clarify that we are not requiring pre-cooling in 
all circumstances. If pre-cooling the food product is necessary to meet 
the requirements of this rule, we would expect that the shipper and the 
loader would ensure that this step is effectively applied as part of 
their responsibilities under this rule. As we discuss in our response 
to Comment 129, however, we have made it clear in this rule, as 
revised, that we are not requiring shippers to specify temperatures to 
carriers and loaders that would be regarded as critical limits for food 
safety purposes. Accordingly, an increase in the temperature of the 
food compartment of a pre-cooled vehicle after products that have not 
been pre-cooled have been loaded into the compartment would not 
necessarily be of concern, as long as the temperature control measures 
applied during the operation ensure that the food will not become 
unsafe during transportation. Finally, nothing in this rule 
specifically precludes the loading of harvested RACs directly from the 
field into pre-cooled trailers provided by carriers because most RACs 
are refrigerated during transportation to minimize spoilage and not to 
ensure their safety. Exceptions include seed sprouts and raw molluscan 
shellfish.
    (Comment 136) Some comments ask us to acknowledge that pre-cooling 
procedures should account for the potential for condensation formation 
during loading operations. One of these comments states that a transit 
container should be pre-cooled only if it is connected to a cold 
storage unit because product temperature and container temperature need 
to be in equilibrium to prevent hotter air from entering the container 
when its doors are opened during loading. The entry of hotter air into 
the container causes condensation, which can create a number of 
problems, including the formation of ice and structural damage to 
shipping containers.
    (Response 136) Under Sec.  1.908(a)(3) of this rule, all 
transportation operations, including loading operations, must be 
conducted under such conditions and controls as necessary to prevent 
the food from becoming unsafe. It is the shipper's responsibility under 
Sec.  1.908(b)(2) to specify to the carrier whether pre-cooling a 
vehicle or transportation equipment is necessary for purposes of 
complying with this rule. We would expect that, if necessary under the 
requirements of this rule, the shipper (who is often also the loader), 
and the loader (if the loader is a different entity), will follow 
appropriate procedures to address the formation of condensation during 
the loading of a pre-cooled vehicle.
    (Comment 137) One comment expresses the view that the carrier needs 
to have unambiguous notice that it is being tendered a shipment of food 
that is not shelf stable and that such notices should be uniform and 
clearly noted in shipping documents so the carrier can make an informed 
decisions regarding the handling of the shipment. Another comment 
recommends that the carrier should be notified in writing when a 
shipment includes a TCS food.
    (Response 137) As we have previously stated, this final rule is 
focused only on food safety, and we have accordingly revised language 
that previously referred to ``foods that are not shelf stable'' to 
``foods that require refrigeration for safety.'' We are using the 
latter term instead of the term TCS food. We agree that it is 
imperative that a carrier that takes responsibility for ensuring that a 
food that requires refrigeration for safety be informed by the shipper 
the operating temperature of the vehicle that is necessary to safely 
transport the food. Such disclosure is now required by revised Sec.  
1.908(b)(2).
    (Comment 138) One comment asserts that thermally insulated tankers 
should be pre-cooled after a high temperature wash. The comment is 
concerned that the contents of the tanker would increase in temperature 
if a tanker is not pre-cooled. The comment suggests removing the 
exclusion for a carrier who transports food in a thermally insulated 
tank from the requirement of proposed 1.908(b)(3).
    (Response 138) We decline this request. It is our understanding 
that it is a common industry practice to clean thermally insulated 
tankers right after unloading products rather than immediately before 
loading. The practice would allow the tankers to cool down after a hot 
temperature wash. Even if a product is loaded into a thermally 
insulated tanker that has just been cleaned with a high temperature 
wash, considering the small surface to volume ratio, we do not believe 
that the product temperature would be raised to a degree that is 
significant with respect to the maintenance of appropriate temperature 
control.
    In addition, thermally insulated tankers are designed and built to 
limit the degree of temperature increase of a food in a given amount of 
time. Therefore, we are retaining the exclusion relating to food in a 
thermally insulated tank from the requirement of 1.908(b)(3).
d. New Sec.  1.908(b)(3) to (5)
    Many of the previously discussed comments depicted a food 
transportation system that is highly diverse, with shippers, receivers, 
loaders, and carriers developing and implementing food safety controls 
that are tailored to their specific circumstances. These controls take 
into account the nature of the food (e.g., ready-to-eat vs. RACs for 
further processing, animal feed vs. human food), the manner of 
transportation (e.g., motor freight vs. rail freight), the nature of 
the transportation vehicle (e.g., owned or leased by the shipper, 
receiver or carrier, tanker vs. hopper vs. boxcar, refrigerated vs. 
unrefrigerated), the location and distance between shipper and 
receiver), the relationship between the shipper and the carrier (e.g., 
simply providing a working boxcar to providing full service 
transportation including temperature control assurance), and the 
involvement of third parties (e.g., brokers, contract loaders at remote 
sites), among other factors. Many comments urged flexibility to allow 
the best practices that have evolved over time for these various 
scenarios to continue to be implemented as long as they are effective 
in assuring food safety. Perhaps the starkest differences raised in the 
comments were between common practices in the motor freight and rail 
freight sectors. Notwithstanding those differences, some members of the 
rail freight sector informed us that they operated in a manner similar 
to many of those in the motor freight sector (for example, providing 
services such as refueling and monitoring refrigerated units and 
arranging for cleaning of bulk cargo cars), and vice versa. These 
commenters argued that assigning specific duties to specific categories 
of entities (e.g., shippers, carriers, even within a sector) could, in 
many cases, have the effect of making some arrangements that have 
worked over time difficult or impossible.
    We acknowledge this diversity and agree that the final rule should 
be structured to accommodate it. We also agree that the rule should be 
structured as much as possible so as not to restrict innovation in the 
relationships between the parties covered by the rule. On the other 
hand, we are compelled to develop a rule that is not so fluid that it 
is unenforceable. Especially when things go wrong, it is important to 
know who is responsible for what functions and to be able to hold them 
accountable. Even during day to day operations, it is important for the 
interacting parties to know where they are responsible and the 
responsibilities of the other parties,

[[Page 20146]]

in order that all parties understand their roles and are sufficiently 
motivated to accomplish their piece of the system.
    In response to Comment 70, we have explained our thinking relative 
to the revised definition of shipper, which reads, ``a person who 
arranges for the transportation of food by a carrier or multiple 
carriers sequentially.'' We explained that we have concluded that this 
is the entity that is in the best position to determine the necessary 
conditions for safe transportation of food. Further, this is the party 
that causes the food to move in commerce, and, as a result, we believe, 
should bear the burden of setting out the safe conditions for that 
movement and assuring that they are met. As a result of these 
determinations, we have concluded that the shipper should be charged by 
this rule with developing and implementing written procedures that 
address how the safety of the food will be assured relative to the 
three major focus areas of this rule, to the extent that they apply to 
the foods that they ship. The three major focus areas are: (1) 
Assurance that vehicles and equipment used in its transportation 
operations are in appropriate sanitary condition; (2) assurance that, 
for bulk cargo, a previous cargo does not make the food unsafe; and (3) 
assurance that, for foods that require refrigeration for safety, the 
food is transported under adequate temperature control. It is necessary 
for these procedures to be in writing in order to facilitate consistent 
implementation by the shipper, especially with changes in personnel, 
and to provide for effective enforcement by FDA and other regulatory 
agencies. We expect that shippers would maintain such written 
procedures to facilitate their operations.
    We recognize that, while the shipper is charged with developing and 
implementing these procedures, in many scenarios the shipper will need 
to secure the services of other parties, such as the receiver, loader, 
or carrier, to accomplish some or all of the measures. We expect that 
those services will be secured under a written agreement, subject to 
the records requirements of Sec.  1.912(a). It is necessary for these 
agreements to be in writing in order to facilitate a consistent 
understanding of responsibilities and consistent implementation of the 
provisions by the shipper, carrier, loader and receiver, and to provide 
for effective enforcement by FDA and other regulatory agencies. Again, 
it is our understanding, based in part on comments discussed earlier in 
this document, that such agreements, usually in the form of contracts, 
are consistent with industry best practice.
    Consequently, we have added three new sections to the proposed rule 
at Sec.  1.908(b)(3) to (5). These new sections require that:
     A shipper must develop and implement written procedures, 
subject to the records requirements of Sec.  1.912(a), adequate to 
ensure that vehicles and equipment used in its transportation 
operations are in appropriate sanitary condition for the transportation 
of the food, i.e., that will prevent the food from becoming unsafe 
during the transportation operation. Measures to implement these 
procedures may be accomplished by the shipper or by the carrier or 
another party covered by this rule under a written agreement, subject 
to the records requirements of Sec.  1.912(a).
     A shipper of food transported in bulk must develop and 
implement written procedures, subject to the records requirements of 
Sec.  1.912(a), adequate to ensure that a previous cargo does not make 
the food unsafe. Measures to ensure the safety of the food may be 
accomplished by the shipper or by the carrier or another party covered 
by this rule under a written agreement, subject to the records 
requirements of Sec.  1.912(a).
     The shipper of food that requires temperature control for 
safety under the conditions of shipment must develop and implement 
written procedures subject to the records requirements of Sec.  
1.912(a), to ensure that the food is transported under adequate 
temperature control. Measures to ensure the safety of the food may be 
accomplished by the shipper or by the carrier or another party covered 
by this rule under a written agreement, subject to the records 
requirements of Sec.  1.912(a), and must include measures equivalent to 
those specified for carriers under Sec.  1.908(e)(1) to (3).
    We proposed at Sec.  1.908(b)(5) that the shipper assumes the 
requirements applicable to the carrier in Sec.  1.908(d)(2)(i) with 
respect to providing a demonstration to the receiver if the shipper and 
carrier have agreed in writing under Sec.  1.908(d)(2)(ii) that the 
shipper is responsible for ensuring that the food was held under 
acceptable temperature conditions during transportation operations. 
When the shipper and carrier have established such an agreement, the 
shipper also assumes the corresponding records requirements of 
Sec. Sec.  1.908(d)(6)(ii) and 1.912(b). This provision was proposed to 
provide flexibility in the manner in which temperature control was 
assured during transportation, and, in particular, who was responsible 
for demonstrating to the receiver that such control was maintained. 
This provision is no longer necessary, and has been deleted from the 
final rule, because the new provision at Sec.  1.908(b)(5) provides the 
same kind of flexibility for temperature control assurance, for foods 
that require refrigeration for safety, as discussed earlier in this 
document.
3. Requirements Applicable to Shippers and Receivers Engaged in 
Transportation Operations (Proposed Sec.  1.908(c))
    We had proposed to establish requirements for shippers and 
receivers addressing food handling during loading and unloading, in 
proposed Sec.  1.908(c). As we discuss in this section, we have 
determined that it is not necessary to include these requirements, as 
they were proposed, in this final rule. We have redesignated Sec.  
1.908(c) in this final rule to specify requirements applicable to 
loaders engaged in transportation operations, which we discuss in the 
following section.
    (Comment 139) One comment states that we should ensure that 
receivers have the ability to test a food product before automatically 
discarding it because the shipper's temperature control specifications 
were exceeded during transport.
    (Response 139) Nothing in this rule requires receivers to discard 
food if the food was subject to deviations from a shipper's temperature 
control specifications during transport. We discuss a receiver's 
responsibilities for handling food that requires temperature control in 
our response to Comment 129.
    (Comment 140) Several comments oppose proposed Sec.  1.908(c)(1) on 
the grounds that the provision would be unnecessarily burdensome and 
would not improve food safety or otherwise contribute to the sanitary 
transportation of food.
    One comment states that foods that are shipped without being 
completely enclosed in packaging, such as RACs, are freely handled by 
consumers when offered for sale in retail establishments. The comment 
notes that no rule currently requires consumers to wash their hands 
prior to the handling these foods and that there is no evidence to 
suggest that transportation vehicle operators present a greater risk of 
contaminating food not completely enclosed in packaging than do a food 
retailer's employees or consumers who also handle these food products 
prior to consumption. The comment also argues that while our proposed 
rule compares Sec.  1.908(c)(1) to requirements in the cGMP regulations 
for human food, particularly 21 CFR 110.10(b), they are

[[Page 20147]]

not the same (the cGMP regulations for human food have been revised in 
the preventive controls for human food final rule and are now in 21 CFR 
part 117, subpart B). The commenter notes that 21 CFR 110.10(b) 
generally requires all persons who work in direct contact with food to 
conform to hygienic practices to the extent necessary to protect 
against food contamination. According to the comment, the proposed hand 
washing provision in this rule does not contemplate that the 
requirement might not be necessary to protect against contamination 
given the existing cGMP hygienic practices provisions.
    Other comments argue that proposed Sec.  1.908(c)(1) should only 
apply if the vehicle operator is reasonably expected to come in 
physical contact with the food. One comment asserts that this proposed 
requirement lacks supporting scientific data, is unnecessary, is not 
feasible in many instances, and would appear to be appropriate only if 
human contact with the food poses a risk that the food will become 
adulterated or otherwise poses a valid health risk to humans or 
animals. Another comment recommends that any requirement for hand-
washing facilities be risk-based and be linked directly to the 
effectiveness of hand-washing for purposes of reducing the risk that 
human handling of food would cause the food to be rendered injurious to 
health or otherwise adulterated.
    Another comment suggests that firms should train drivers with 
respect to safe handling practices and that we should leave the 
selection of the sanitary methods for the handling of foods not 
entirely enclosed by packaging up to the transportation firms. The 
comment suggests, for example, that vehicle operators may be instructed 
to use disposable gloves, sanitary wipes, and/or a customer's hand 
washing facilities depending on the circumstances. One comment 
expresses concern that this provision would require the installation of 
additional sinks in virtually all food distribution centers at a great 
cost to the industry.
    (Response 140) After considering these comments, we have decided to 
remove the provision in proposed Sec.  1.908(c)(1) from this final 
rule. We have determined that this provision is unnecessary because the 
specific circumstance that proposed Sec.  1.908(c)(1) would address, 
vehicle operators handling food not completely enclosed by a container, 
is already addressed by the broader requirement of Sec.  1.908(a)(3), 
which requires that all transportation operations be conducted under 
such conditions and controls necessary to prevent the food from 
becoming unsafe during transportation operations. In particular, Sec.  
1.908(a)(3)(ii) includes hand washing as an example of measures that 
can be taken to protect food transported in bulk vehicles or food not 
completely enclosed by a container from contamination and cross-contact 
during transportation operations. Providing vehicle operators access to 
hand washing facilities is one method for preventing the contamination 
of food, but we agree that it may not always be necessary. By removing 
proposed Sec.  1.908(c)(1) from this rule, we are allowing flexibility 
for the transportation industry to determine what control measures 
would be necessary in any given set of circumstances.
    Furthermore, we have reached the same conclusion concerning the 
provision in proposed Sec.  1.908(c)(2), which would have required 
shippers and receivers of food that can support the rapid growth of 
undesirable microorganisms in the absence of temperature control during 
transportation, to carry out loading and unloading operations under 
conditions that would ``prevent the food from supporting such microbial 
growth.'' We have removed that provision from this final rule because 
our expectations for temperature control during loading and unloading 
operations are set forth in new Sec.  1.908(a)(3)(iii), which requires 
persons subject to this rule to take effective measures to ensure that 
food that requires temperature control for safety is transported under 
adequate temperature control; see Comment 132 and Comment 141.
    (Comment 141) One comment states that there are no provisions in 
the rule to ensure that insanitary conditions have not contaminated the 
food before a carrier becomes involved. The comment asserts that the 
rule does not require specifications for conditions that must be 
maintained on loading and unloading docks, and that carriers are not 
given an opportunity to inspect and confirm either the condition of the 
cargo or the facilities where the food is picked-up or delivered.
    (Response 141) We disagree with the comment. The requirements of 
Sec.  1.908(a)(3) and (c), while general in nature, address sanitary 
transportation practices applicable to the loading and unloading of 
food. In addition, this rule does not preclude a carrier from 
establishing agreements with the owner or operator of the facility or 
loading dock to inspect or confirm the condition of cargo or facilities 
prior to accepting a load.
4. Requirements Applicable to Loaders Engaged in Transportation 
Operations (New Sec.  1.908(c))
    As we stated in the previous section, we have redesignated Sec.  
1.908(c) in this final rule as, ``Requirements applicable to loaders 
engaged in transportation operations.'' The provisions we have included 
in this section arise from our consideration of comments relevant to 
loading operations in other sections of this final rule; see Comment 
125, Comment 126, Comment 127, Comment 128, and Comment 129.
5. Requirements Applicable to Receivers Engaged in Transportation 
Operations (New Sec.  1.908(d))
    We have established requirements applicable to receivers engaged in 
transportation operations in Sec.  1.908(d) of this final rule and have 
moved the corresponding requirements applicable to carriers (proposed 
Sec.  1.908(d)) to new Sec.  1.908(e), discussed in the following 
section. The provisions we have included in new Sec.  1.908(d) arise 
from our consideration of comments relevant to food that requires 
temperature control for safety, which we discuss in Comment 129.
6. Requirements Applicable to Carriers Engaged in Transportation 
Operations (Proposed Sec.  1.908(d), Now New Sec.  1.908(e))
    As discussed in section IV.E.2, we have concluded that the shipper 
should be charged by this rule with developing and implementing written 
procedures that address how the safety of the food will be assured 
relative to the three major focus areas of this rule, to the extent 
that they apply to the foods that they ship. The three major focus 
areas are: (1) Assurance that vehicles and equipment used in its 
transportation operations are in appropriate sanitary condition; (2) 
assurance that, for bulk cargo, a previous cargo does not make the food 
unsafe; and (3) assurance that, for foods that require refrigeration 
for safety, the food is transported under adequate temperature control. 
We recognize that, while the shipper is charged with developing and 
implementing these procedures, in many scenarios the shipper will need 
to secure the services of other parties, such as carrier, to accomplish 
some or all of the measures. We expect that those services will be 
secured under a written agreement, subject to the records requirements 
of Sec.  1.912. It is our understanding, based in part on comments 
discussed earlier in this document, that such agreements,

[[Page 20148]]

usually in the form of contracts, are consistent with industry best 
practice.
    Consequently, we have added three new sections to the proposed rule 
at Sec.  1.908(b)(3) to (5). These new sections require that:
     A shipper must develop and implement written procedures 
subject to the records requirements of Sec.  1.912(a), adequate to 
ensure that vehicles and equipment used in its transportation 
operations are in appropriate sanitary condition for the transportation 
of the food, i.e., that will prevent the food from becoming unsafe 
during the transportation operation. Measures to implement these 
procedures may be accomplished by the shipper or by the carrier or 
another party covered by this rule under a written agreement subject to 
the records requirements of Sec.  1.912(a).
     A shipper of food transported in bulk, must develop and 
implement written procedures subject to the records requirements of 
Sec.  1.912(a), adequate to ensure that a previous cargo does not make 
the food unsafe. Measures to ensure the safety of the food may be 
accomplished by the shipper or by the carrier or another party covered 
by this rule under a written agreement subject to the records 
requirements of Sec.  1.912(a).
     The shipper of food that requires temperature control for 
safety under the conditions of shipment must develop and implement 
written procedures subject to the records requirements of Sec.  
1.912(a), to ensure that the food is transported under adequate 
temperature control. Measures to ensure the safety of the food may be 
accomplished by the shipper or by the carrier or another party covered 
by this rule under a written agreement subject to the records 
requirements of Sec.  1.912(a) and must include measures equivalent to 
those specified for carriers under Sec.  1.908(e)(1) to (3).
    Consistent with these new provisions in the previous section 
applicable to requirements for shippers, we have included language at 
Sec.  1.908(e) (proposed Sec.  1.908(d)) that makes the provisions of 
that section applicable to a carrier only when the carrier and shipper 
have a written agreement that the carrier is responsible, in whole or 
part, for sanitary conditions during the transportation operation. Each 
provision is applicable only when it is relevant to the provisions of 
the agreement between the carrier and the shipper. For example, the 
carrier and the shipper may have a written agreement that states that 
the carrier is to precool the vehicle and set and monitor operating 
temperatures in the vehicle, based on instructions from the shipper. In 
this case, the carrier would be responsible for meeting the 
requirements of Sec.  1.908(e) that are relevant to temperature control 
(i.e., Sec.  1.908(e)(2) and (3), discussed in this document). If the 
agreement did not assign responsibility for other sanitary conditions 
to the carrier, e.g., cleanliness of the vehicle, previous cargo 
control, the other provisions of Sec.  1.908(e) would not be applicable 
to the carrier.
a. Proposed Sec.  1.908(d)(1)
    We proposed to require that a carrier must supply a vehicle and 
transportation equipment that meets any requirements specified by the 
shipper in accordance with Sec.  1.908(b)(1), and is otherwise 
appropriate to prevent the food from becoming filthy, putrid, 
decomposed or otherwise unfit for food, or being rendered injurious to 
health from any source during the transportation operation.
    We have made the following revision to proposed Sec.  1.908(d)(1) 
(now Sec.  1.908(e)(1)) for consistency with changes elsewhere in the 
final rule to focus the rule on food safety only. We have changed the 
proposed phrase ``prevent the food from becoming filthy, putrid, 
decomposed or otherwise unfit for food, or being rendered injurious to 
health'' to ``prevent the food from becoming unsafe.''
    (Comment 142) One comment asks us to require LTL carriers to 
implement written procedures to ensure the compatibility of each food 
contained within an LTL load and to require that the carrier be able to 
demonstrate full compliance with each shipper's food transportation 
specifications upon request.
    (Response 142) We decline to make this change. We have assigned 
responsibility for ensuring that a vehicle onto which food not 
completely enclosed by a container is loaded is in appropriate sanitary 
condition, to the loader, giving consideration to specifications 
provided by the shipper (see Comment 70). Among other factors, the 
loader is to consider whether the vehicle is in adequate physical 
condition and whether it is free of visible evidence of pest 
infestation and previous cargo that could cause the food to become 
unsafe. In the case of an LTL load, we would expect that the loader 
would check to see if any previously loaded cargo could potentially 
contaminate food not completely enclosed by a container in a subsequent 
load. We would also expect that the shipper of food not completely 
enclosed by a container on an LTL load would generally instruct the 
loader to inspect (where the loader and the shipper are not the same 
person), consistent with the shipper's obligations under Sec.  
1.908(b)(3).
    (Comment 143) Another comment notes that the carrier has the 
responsibility for providing a container in good mechanical condition 
and that is reasonably clean of dirt, debris and foul odors. However, 
the comment states that the shipper should be responsible for any 
``sanitizing'' that might be required for the sanitary transportation 
of a particular food/beverage or commodity.
    (Response 143) We are aware that, depending upon the circumstances 
and the agreement between the parties, current practice is that either 
shippers, loaders or carriers may wash and/or sanitize vehicles before 
they are loaded, or they may contract with a third party to perform 
that function. We see no public health benefit in changing current 
practice by mandating that one party or another perform the function. 
As previously discussed, in new Sec.  1.908(b)(3) we have required that 
shippers develop and implement written procedures specifying how they 
will ensure that vehicles and equipment used in its transportation 
operations are in appropriate sanitary condition for the transportation 
of the food. We would expect such procedures to include cleaning and 
sanitizing procedures as appropriate to the food and conditions of 
shipment. However, new Sec.  1.908(b)(3) also provides that the shipper 
may reach an agreement with the carrier, or another party covered by 
this rule, to perform this function. If a carrier agrees to perform 
this function, Sec.  1.908(e)(1) requires that they ensure that the 
vehicle meets the shippers specifications in that regard.
    (Comment 144) One comment states that some jurisdictions prohibit 
carriers from washing out their truck's trailers because of local water 
quality regulations designed to protect the environment from 
contaminated water runoff. The comment further asserts that this rule, 
therefore, places carriers in the untenable position of having to 
choose which regulation to follow. The comment asks us to provide 
clarity regarding the interaction between this rule and state and local 
regulations that may restrict or prohibit truck washing.
    (Response 144) This rule is not intended to preempt state and local 
requirements regarding water runoff and water quality issues that would 
affect truck washing. Carriers affected by local requirements that 
restrict or prohibit truck washing must, even now, determine how to 
meet any

[[Page 20149]]

requirements imposed upon them by their shipper customers when faced 
with local washing restrictions. This rule does not change that fact. 
As discussed in response to the previous comment, in new Sec.  
1.908(b)(3) we have required that shippers develop and implement 
written procedures specifying how they will ensure that vehicles and 
equipment used in their transportation operations are in appropriate 
sanitary condition for the transportation of the food. We would expect 
such procedures to include cleaning and sanitizing procedures as 
appropriate to the food and conditions of shipment. However, new Sec.  
1.908(b)(3) also provides that the shipper may reach an agreement with 
the carrier, or another party covered by this rule, to perform this 
function. If a carrier agrees to perform this function Sec.  
1.908(e)(1) requires that they ensure that the vehicle meets the 
shippers specifications in that regard. In some cases the shipper may 
choose to perform the function, if it has facilities to do so.
b. Proposed 1.908(d)(2)
    We proposed to require that a carrier must, once the transportation 
operation is complete, demonstrate to the shipper and if requested, to 
the receiver, that it has maintained temperature conditions during the 
transportation operation consistent with those specified by the shipper 
in accordance with Sec.  1.908(b)(3). We proposed that these 
demonstrations may be accomplished by any appropriate means agreeable 
to the carrier and shipper, such as the carrier presenting printouts of 
a time/temperature recording device or a log of temperature 
measurements taken at various times during the shipment. We also 
proposed that a carrier would not be subject to the requirement of 
Sec.  1.908(d)(2)(i) if the carrier and shipper agree in writing, 
before initiation of the transportation operations, that the shipper 
would be responsible for monitoring the temperature conditions during 
the transportation operation or otherwise ensuring that the food was 
held under acceptable temperature conditions during the transportation 
operation. Finally, we proposed that a carrier must provide the written 
agreement to the receiver, if requested, and that this written 
agreement would be subject to the records requirements of Sec.  
1.912(b).
    Consistent with our discussion concerning the duties of the shipper 
as a result of the requirements of Sec.  1.908(b)(5), we have removed 
the provisions of proposed Sec.  1.908(d)(2)(ii), concerning 
alternative arrangements for the responsibility to provide temperature 
control information to the shipper and receiver. This provision is no 
longer needed because new Sec.  1.908(b)(5) and the new language at new 
Sec.  1.908(e) provide the same flexibility to assign responsibility 
for this function as was provided by proposed Sec.  1.908(d)(2)(ii).
    (Comment 145) One comment asserts that an LTL carrier should have 
the flexibility to deviate from the temperature specified by the 
shipper when transporting mixed loads that contain food from more than 
one shipper. The comment further asserts that we should allow LTL 
carriers to set temperatures for such mixed loads based on the lowest 
temperature needed to safely transport TCS foods in any given load, 
even though this temperature may differ from that specified by any of 
the other LTL shippers.
    (Response 145) We agree with the comment. Our expectation is that, 
generally, each of the shippers of food that require temperature 
control for safety in an LTL load would provide an operating 
temperature to the carrier. These temperatures represent temperatures 
that will ensure that the food does not become unsafe during 
transportation. In most cases, they will also assure marketability and 
quality preservation, as desired by the shipper. With regards to the 
requirements of this regulation, if a carrier who has accepted 
responsibility for temperature control during transit selects the 
coldest temperature of those provided by the shippers they will be 
meeting their responsibility under Sec.  1.908(e)(2). However, we note 
that there may be times when a shipper does not want their product to 
be exposed to excessively cold temperatures for quality reasons. In 
this case, the shipper would be well advised to so instruct the 
carrier. We would consider such instructions to be outside the scope of 
this regulation as they do not impact food safety.
    (Comment 146) Another comment asks us to develop and require 
carriers to adhere to air and product temperature-monitoring standards 
to meet the requirements specified by the shipper under proposed Sec.  
1.908(b)(3). The comment asserts that these requirements should include 
adequate and sanitary representative sampling methods, address 
appropriate temperature measurement device placement, and consider the 
effects of load configurations and other contributing factors on 
temperature control during transportation. The comment asks us to 
consider the potential need for shippers to require both air and 
product temperature monitoring and recommends that any requirements 
related to verification of product temperatures should be incorporated 
in a manner that would not involve undue or burdensome costs.
    (Response 146) We do not agree. We think these types of detailed 
provisions are better for guidance than for regulations. Because of the 
diversity of transportation operations, including the variety of foods 
transported, we have concluded that shippers need to be given 
considerable latitude to develop temperature controls for their 
operations, as long as they do, in fact, serve to prevent the food from 
becoming unsafe during transportation. Some of the recommendations 
contained in the comment, e.g., a requirement to monitor both air and 
product temperature, would, in many cases, establish a level of 
temperature control substantially more rigorous than current best 
industry practices, which have proven to be effective in providing for 
sanitary food transportation and which we have incorporated into this 
final rule.
c. Proposed Sec.  1.908(d)(3)
    We proposed to require that, before offering a vehicle or 
transportation equipment with an auxiliary refrigeration unit for use 
for the transportation of food that can support the rapid growth of 
undesirable microorganisms in the absence of temperature control, a 
carrier must precool each mechanically refrigerated freezer and cold 
storage compartment as specified by the shipper in accordance with 
paragraph (b)(3) of this section.
    We have made the following revisions to proposed Sec.  1.908(d)(3) 
(now Sec.  1.908(e)(3)) for consistency with changes elsewhere in the 
final rule to focus the rule on food safety only. We have changed the 
proposed phrase ``food that can support the rapid growth of undesirable 
microorganisms in the absence of temperature control'' to ``food that 
requires temperature control for safety.'' We have also removed the 
word ``freezer,'' because we believe that the pre-cooling of freezer 
vehicles is a step taken to preserve product quality and marketability 
and not to prevent the food from becoming unsafe.
d. Proposed Sec.  1.908(d)(4)
    We proposed to require that a carrier that offers a bulk vehicle 
for food transportation must provide information to the shipper that 
identifies the three previous cargoes transported in the vehicle. We 
proposed that the shipper and carrier would be able to agree in writing 
that the carrier would provide information identifying fewer than three

[[Page 20150]]

previous cargoes, or that the carrier would not need to provide any 
such information if procedures have been established that would ensure 
that the bulk vehicle being offered would be adequate for the intended 
transportation operation, for example, if the carrier by contract would 
agree to offer vehicles dedicated exclusively to transporting a single 
type of product. We also proposed that the written agreement would be 
subject to the records requirements of Sec.  1.912(b).
    Consistent with our discussion concerning the duties of the shipper 
as a result of the requirements of Sec.  1.908(b)(4), we have removed 
the provisions of proposed Sec.  1.908(d)(4), concerning alternative 
arrangements for the responsibility to provide previous cleaning 
information to the shipper. This provision is no longer needed because 
new Sec.  1.908(b)(4) and the new language at new Sec.  1.908(e) 
provide the same flexibility to assign responsibility for this function 
as was provided by proposed Sec.  1.908(d)(4).
    (Comment 147) A few comments support this proposed provision. One 
comment notes that the proposed requirement is an existing common 
industry practice. Another comment informs us that our proposal is 
feasible. Another comment expressed the view that requiring 
identification of the three previous loads hauled is excessive and 
unnecessary for accomplishing the goal of sanitary food transport.
    Several comments state that it is currently common for carriers to 
provide information about the single previous cargo hauled on a bulk 
transport vehicle to shippers under procedures already in place and 
widely accepted within both the human and animal food transportation 
industries. One of these comments states that for shippers, knowing the 
immediately previous load hauled in a bulk conveyance and knowing 
whether appropriate clean-out procedures have been followed, if needed 
to ensure the conveyance meets the needs of the shipper based upon the 
type of food to be loaded, is critically important. Another comment 
states that knowing what type of feed was hauled in a dedicated truck 
immediately before the present load is useful information when 
assessing the possibility of the contamination of the present load. 
Another comment offers the view that the shipper, in accordance with 
the FSMA preventive controls rules, would maintain written procedures 
as part of its food safety plan to ensure adequate cleanout of vehicles 
is performed and documented. According to this commenter, this written 
plan should suffice in lieu of any additional documentation required to 
support compliance to this rule.
    Another comment states that the request for three previous cargoes 
is impractical for LTL shipments, where tractors hauling trailers with 
packaged goods may stop at multiple locations to pick up shipments. 
Several comments assert that the carrier's release of information 
regarding multiple previous loads could result in the improper 
disclosure of sensitive business information because it could involve 
divulging to a shipper's competitors detailed information regarding the 
shipper's deliveries to their customers. A related comment asserts that 
the tracking of three previous cargoes is impractical, and perhaps 
impossible, because trailers are attached to tractor transportation 
vehicles on a continually changing basis.
    (Response 147) These comments indicate that under current industry 
practices, in some cases, shippers acquire information from carriers 
about cargo previously transported in a bulk vehicle and that this 
information has value to them in ensuring that their cargo will not be 
at risk of contamination during transportation. In other cases, 
shippers do not seek to obtain this information and instead rely on 
other measures to ensure that contamination will not occur, such as 
guarantees that the carrier will provide a vehicle dedicated to 
transporting a single type of cargo. Further, we have concluded that 
such a common practice demonstrates that this provision would not 
adversely impact businesses because of concerns about the disclosure of 
sensitive business information.
    However, none of the comments supported the need to identify more 
than the single previous shipment and some suggest that it would be 
unduly burdensome. We are persuaded by these comments, and, 
consequently, while we have retained proposed Sec.  1.908(d)(4) (new 
Sec.  1.908(e)(4)), we have revised it to require the carrier to 
provide, on request from the shipper (when such function is the subject 
of a written agreement between the shipper and the carrier as provided 
for under Sec.  1.908(b)(4)), information about the last previous cargo 
transported in a bulk vehicle. With respect to LTL shipments, we note 
that this provision does not apply in circumstances where the vehicle 
is used to transport packaged goods. This provision only applies to 
vehicles in which food is shipped in bulk, with the food coming into 
direct contact with the inner surfaces of the vehicle.
    (Comment 148) A comment asks us to exempt vehicles that transport 
raw materials to rendering operations from the requirement of 
identifying prior cargoes.
    (Response 148) While we recognize that materials destined for 
rendering will receive a heat treatment to destroy pathogens, we are 
not exempting carriers from the requirement that they identify the 
vehicle's previous cargo to the shipper supplying raw materials to a 
rendering operation because the shipper might wish to determine whether 
the bulk vehicles carried some previous cargoes that could contaminate 
the raw material in a way that would not be addressed by the heat 
processes of the rendering operation (e.g., heat stable chemical 
contaminants). We are retaining this provision to allow the shipper to 
obtain this information from the carrier, if the shipper deems it 
necessary for the purposes of ensuring that his product does not become 
unsafe during transportation.
    (Comment 149) Another comment asserts that carriers that offer bulk 
food vehicles for food transportation already comply with comparable 
requirements under the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Bioterrorism Act), and 
further asserts that compliance with these existing requirements is 
sufficient to protect food safety during transportation operations.
    (Response 149) We disagree. We have not established requirements in 
any other regulations that carriers must provide information to 
shippers that identifies previous cargoes transported in bulk vehicles 
or that describes the most recent cleaning of the vehicle. We are 
establishing these requirements in this rule pursuant to the objective 
of this rulemaking, which is to require that persons engaged in the 
transportation of food use sanitary transportation practices to ensure 
that food does not become unsafe during transportation. The regulations 
we have established under the Bioterrorism Act, as they pertain to food 
transportation, address a different purpose. Those regulations in 21 
CFR part 1 address records that must be kept by certain persons, 
including food transporters, that would be available to FDA to identify 
the immediate previous sources, and immediate subsequent recipients, of 
food, in order for FDA to address contamination that presents serious 
adverse health consequences or death to humans or animals.
    (Comment 150) A comment states that if a bulk trailer is offered 
for loading with a wash ticket, there is little reason to provide 
information about what was previously hauled therein. This commenter 
asserts that in many cases a

[[Page 20151]]

tractor operator will obtain a trailer with a wash ticket and not know 
the last food hauled in the trainer.
    (Response 150) As we discuss in our response to Comment 149, we 
revised this rule in Sec.  1.908(e)(4) so that carriers will only have 
to provide shippers with information about the previous load if the 
shipper requests the information (in cases where the carrier and 
shipper have a written agreement requiring the shipper to provide such 
information). We would not expect that a shipper would request this 
information under circumstances in which the shipper does not regard it 
as necessary under the terms of its business relationship with the 
carrier, for example, when the carrier by contract has agreed to only 
provide vehicles that have previously hauled compatible ingredients or 
to present a wash ticket to the shipper when the vehicle is offered.
    (Comment 151) Another comment notes that railroads do not maintain 
information on previous cargoes. The commenter states that there is no 
industry process to track and identify prior shipments in rail cars 
that travel throughout the general system of rail transportation in 
interchange service. Railroads would not have this information for 
privately owned rail cars and they would not necessarily have the 
information for their own rail cars that have been in service on other 
railroads or rail cars that have been placed into pool arrangements. 
Finally, the commenter asks us to revise this final rule so that a 
railroad carrier would only be required to provide information to the 
shipper that identifies the three previous movements when a shipper 
requests this information, the railroad carrier has access to the 
information through its ordinary course of business, and the 
information is not otherwise available to the shipper.
    Similar comments state that it can be difficult to obtain last-load 
hauled information from rail carriers unless the railcars being 
utilized are owned, leased, or controlled by the shipper, or the 
shipper is the one who is the consignee/consignor or payer of the 
freight bill. Currently, no consistent or reliable mechanism exists 
among rail carriers from which to obtain such information.
    One comment states that, given the complexity of the rail transport 
network and the efficiency and safety of current industry practices, 
the final rule should exclude rail carriers to avoid imposing needless 
and onerous burden on railroads. The commenter states that the shipper 
is uniquely positioned to understand the sanitary needs of the goods it 
ships and therefore can prevent cross-contamination and inspect and 
clean railcars prior to loads.
    Another comment states that section 11904 of the Interstate 
Commerce Commission Termination Act (ICCTA) prohibits railroads subject 
to the Surface Transportation Board (STB's) jurisdiction from 
disclosing any ``information about the nature, kind, quantity, 
destination, consignee, or routing of property tendered or delivered to 
that rail carrier for transportation . . . that may be used to the 
detriment of the shipper or consignee or may disclose improperly, to a 
competitor, the business transactions of the shipper or consignee.'' 49 
U.S.C. 11904(a)-(b). The commenter also notes that the statute 
prohibits other shippers from soliciting or knowingly receiving such 
information from a railroad. The commenter notes, for example, if 
loaded railcars are delivered to one shipper in a terminal area and the 
empty railcars are provided to a second shipper in the same terminal 
area, disclosing the prior load would inform the second shipper as to 
the nature of its competitor's previous cargo. The commenter argues 
that this type of disclosure is prohibited by ICCTA.
    (Response 151) We acknowledge that the use of railcars in 
interchange service as described by these comments would likely make it 
difficult or impossible for the railcar's provider, e.g., a railroad 
operator, to be able to provide information about the identity of a 
bulk vehicle's previous cargoes to the shipper as we proposed in Sec.  
1.908(d)(4). We also acknowledge the challenge that section 11904 of 
the ICCTA may pose with respect to exchanging such information for rail 
shipments. However, as discussed previously, we have revised this rule 
at Sec.  1.908(b)(4) to require the shipper to develop written 
procedures adequate to ensure that a previous cargo does not make the 
food unsafe. These procedures may describe actions that the shipper may 
take to provide this assurance (e.g., cleaning the vehicle, using a 
dedicated vehicle), or they can include actions that the carrier in 
accordance with Sec.  1.908(e), or another party covered by this 
regulation may take to provide this assurance (e.g., providing 
information about the last previous cargo of the vehicle, providing a 
dedicated vehicle). In the case of a rail operator that does not 
provide services related to the safety of bulk food cargoes to be 
loaded onto rail cars that they provide to the shipper (e.g., 
identifying previous cargos) we would not expect that there would be a 
written agreement between the shipper and the carrier to provide such 
information. Consequently, this rule would place no burden upon such a 
rail operator to provide such information.
    (Comment 152) Another comment notes that contract transportation 
haulers notify renderers and feed manufacturers about prior loads, 
including nonfoods and animal feed ingredients such as restricted use 
proteins (i.e., relative to the concern for the agent that causes 
transmissible spongiform encephalopathy). The comment asserts that 
carriers should be responsible for cleaning out the truck trailer, 
container, or railcar after hauling restricted use proteins or 
hazardous materials before hauling other animal feed ingredients.
    (Response 152) While the procedures described by the commenter may 
reflect the practices of most contract haulers handling raw materials 
for rendering, as we discussed previously, we have revised this rule at 
Sec.  1.908(b)(4) to require the shipper to develop written procedures 
adequate to ensure that a previous cargo does not make the food unsafe. 
These procedures may describe actions that the shipper may take to 
provide this assurance (e.g., cleaning the vehicle, using a dedicated 
vehicle), or they can include actions that the carrier in accordance 
with Sec.  1.908(e), or another party covered by this regulation may 
take to provide this assurance (e.g., cleaning the vehicle, providing a 
dedicated vehicle). We believe that it would be unnecessarily 
restrictive to place the burden for on food sanitation step, i.e., 
cleaning, on a specific category of persons covered by this rule, and 
that the system described at Sec.  1.908(b)(4) and (e) is sufficiently 
protective of public health.
    This rule does not address controls for specific food safety 
hazards, such as the agent that causes transmissible spongiform 
encephalopathy. As we stated in the proposed rule (79 FR 7006 at 7011), 
we have established requirements in Sec.  589.2000 (``Animal proteins 
prohibited in ruminant feed'') and Sec.  589.2001 (``Cattle materials 
prohibited in animal food or feed to prevent the transmission of bovine 
spongiform encephalopathy'') addressing cleanout requirements and 
dedicated equipment requirements for equipment used in the distribution 
of specified feed ingredients to prevent the contamination of ruminant 
feed and animal food or feed, respectively.
e. Proposed Sec.  1.908(d)(5)
    We proposed to require that a carrier that offers a bulk vehicle 
for food transportation must provide information to the shipper that 
describes the most

[[Page 20152]]

recent cleaning of the bulk vehicle, except that a shipper and carrier 
may agree in writing that the carrier need not provide any such 
information, if the carrier follows procedures that would ensure that 
the bulk vehicle offered will be adequate for the intended 
transportation operation, e.g., if the carrier has contractually agreed 
to use a specified cleaning procedure at specified intervals or if the 
shipper cleans the vehicle at his own facility, subject to the records 
requirements of Sec.  1.912(b).
    Consistent with our discussion concerning the duties of the shipper 
as a result of the requirements of Sec.  1.908(b)(4), we have removed 
the provisions of proposed Sec.  1.908(d)(5), concerning alternative 
arrangements for the responsibility to provide previous cleaning 
information to the shipper. This provision is no longer needed because 
new Sec.  1.908(b)(4) and the new language at new Sec.  1.908(e) 
provide the same flexibility to assign responsibility for this function 
as was provided by proposed Sec.  1.908(d)(5).
    (Comment 153) Some comments support the proposed provision. One 
comment states that all cleanout procedures, including wash out for 
trailers, should be documented.
    (Response 153) We have retained these provisions in this final rule 
with some modifications as noted in the paragraphs immediately 
preceding this comment.
    (Comment 154) One comment asserts that given the strict procedures 
currently in place to manage medicated feed transport, we do not need 
to include a previous vehicle cleaning provision in this rule with 
respect to the transportation of medicated feed.
    (Response 154) Under this rule as we have revised it, the shipper 
has the prerogative to request from the carrier information describing 
the bulk vehicle's most recent cleaning when a contract between the 
shipper and receiver provides for such information exchange. We are 
retaining this provision to allow the shipper to obtain this 
information from the carrier if the shipper deems it necessary under 
these circumstances for the purposes of ensuring that his product does 
not become unsafe during transportation. Our regulations addressing 
medicated feed cleanout procedures (21 CFR 225.65 and 225.165) do not 
provide shippers with access to this type of information from carriers. 
If, however, a shipper has determined that the provisions of 21 CFR 
225.65 or 225.165 adequately address his circumstances, the shipper may 
choose to not request this information from the carrier.
    (Comment 155) Another comment states that providing information to 
the shipper describing the cleaning of a bulk rail car is beyond the 
current capabilities of railroad operators. The commenter observes that 
railroads do not generally clean rail cars and do not track the 
cleaning of railcars. The commenter states that railroad operators do 
not have access to cleaning records for rail cars that they do not own 
that are cleaned by customers on site or at third-party locations. The 
commenter also states that, even if a railroad owns the railcar, 
railcar operators routinely enter into contractual arrangements whereby 
the lessee becomes responsible for cleaning the railcar, and that based 
on the lack of incidents involving food transported in bulk railcars, 
there is no reason to impose these burdensome requirements on railroad 
carriers. The commenter therefore asks us to revise this final rule to 
require a railroad carrier to provide information to the shipper that 
describes the most recent cleaning of a bulk vehicle when a shipper 
requests such information, the railroad carrier has access to the 
information through its ordinary course of business, and the 
information is not otherwise available to the shipper.
    (Response 155) We acknowledge that the use of railcars in 
interchange service as described by this these comments would likely 
make it difficult or impossible for the railcar's provider, e.g., a 
railroad operator, to be able to provide information about the previous 
cleaning of a bulk car to the shipper as we proposed in Sec.  
1.908(d)(5). However, as we discussed previously, we have revised this 
rule at Sec.  1.908(b)(4) to require the shipper to develop written 
procedures adequate to ensure that a previous cargo does not make the 
food unsafe. These procedures may describe actions that the shipper may 
take to provide this assurance (e.g., cleaning the vehicle, using a 
dedicated vehicle), or they can include actions that the carrier in 
accordance with Sec.  1.908(e), or another party covered by this 
regulation may take to provide this assurance (e.g., cleaning the 
vehicle, providing a dedicated vehicle). In the case of a rail operator 
that does not provide services related to the safety of bulk food 
cargos to be loaded onto rail cars that they provide to the shipper 
(e.g., providing information related to the cleaning of vehicles) we 
would not expect that there would be a written agreement between the 
shipper and the carrier to provide such information. Consequently, this 
rule would place no burden upon such a rail operator to provide such 
information.
    (Comment 156) Another comment asks us to permit companies to use a 
written single generic guideline for all hired carriers with procedures 
addressing prior loads and the cleaning of bulk vehicles. The comment 
states that if a carrier commits to a shipper to use dedicated bulk 
containers or compatible raw ingredients and products, there should be 
no need for further procedures unless the shipper and carrier want to 
specify further details.
    (Response 156) A shipper may operate in the manner described in 
this comment consistent with the requirements of this rule in Sec.  
1.908(e)(4) and (5). We acknowledge that an agreement provided to all 
hired carriers might state circumstances in which the shipper would 
want to know the identity of the previous cargo and information about 
the most recent cleaning of a bulk vehicle.

F. What training requirements apply to carriers engaged in 
transportation operations? (Sec.  1.910)

    We proposed to require that carriers must provide training to 
personnel engaged in transportation operations that provides an 
awareness of potential food safety problems that may occur during food 
transportation, basic sanitary transportation practices to address 
those potential problems and the responsibilities of the carrier under 
this rule. The training must be provided upon hiring and as needed 
thereafter. We also proposed to require that carriers must establish 
and maintain records documenting the aforementioned training. Such 
records must include the date of the training, the type of training, 
and the person(s) trained. These records are subject to the records 
requirements of Sec.  1.912(c). In table 9, we describe revisions to 
proposed Sec.  1.910 and following the table we respond to comments 
related to these provisions.

[[Page 20153]]



    Table 9--Sec.   1.910 What Training Requirements Apply to Carriers Engaged in Transportation Operations?
----------------------------------------------------------------------------------------------------------------
              Proposed section                           Description                        Revision
----------------------------------------------------------------------------------------------------------------
1.910(a)....................................  Requires carriers to provide      Requires carriers to provide
                                               awareness training to personnel   awareness training to personnel
                                               engaged in transportation         engaged in transportation
                                               operations.                       operations when the carrier and
                                                                                 shipper have agreed via written
                                                                                 contract that the carrier is
                                                                                 responsible for the sanitary
                                                                                 conditions during
                                                                                 transportation operations.
1.910(b)....................................  Requires that carriers maintain   No change.
                                               records documenting the
                                               training required in (a).
----------------------------------------------------------------------------------------------------------------

    (Comment 157) Several comments state that the training requirements 
should also apply to shippers and receivers who conduct loading and 
unloading operations in which they contact or handle food.
    (Response 157) We do not agree and affirm our tentative conclusion 
in the proposed rule (79 FR 7006 at 7027) that training needs for 
shippers and receivers would be most appropriately addressed through 
the training provisions in our cGMP regulations for human and animal 
food because these regulations contain provisions related to sanitation 
focused employee training specifically tailored for entities that would 
operate as shippers, receivers and loaders under this rule.
    (Comment 158) Some comments from the railroad industry state that 
railroads that do not handle food should not be subject to the training 
requirements of this rule and that these requirements should instead 
apply to shippers and receivers who actually contact and handle food 
shipped by rail.
    (Response 158) We have addressed the portion of this comment that 
relates to training for shippers and receivers in our response to 
Comment 157. We agree that carriers, including railroads, that do not 
perform food transportation activities that may affect the sanitary 
condition of food would not benefit from training related to sanitary 
food transportation. For this reason, we have modified the carrier 
training requirement to require such training when the carrier and 
shipper have agreed in a written contract that the carrier is 
responsible, in whole or part, for the sanitary conditions during 
transportation operations. This revision is designed to be consistent 
with revisions at Sec.  1.908(b)(3), (4), (5), and (e), discussed in 
the relevant sections of this document, that address when the carrier 
is made responsible for certain sanitary conditions during food 
transportation operations under this rule.
    (Comment 159) Some comments state that training should be available 
to State and local regulatory officials.
    (Response 159) As we discuss in our response to Comment 19, we are 
aware of the training needs for regulators and we will seek to 
establish partnerships with other Federal Agencies, and States and 
Tribes in implementing this rule which would include addressing these 
training needs.
    (Comment 160) A comment requests more information about what type 
and amount of training would be sufficient to meet the requirements of 
this rule. It also states that a one-size-fits-all approach would 
likely overburden carriers who have little or no contact with food in 
their operations and likewise be insufficient for carriers whose 
operations involve a high degree of contact with food. Some comments 
mention that the content, frequency and length of training should be 
within the discretion of the carrier. Some comments state that a half-
day long training seems unnecessary for this regulation. One comment 
requests that we provide flexibility in the training requirements for 
the transportation of chemical food additives and GRAS substances.
    (Response 160) Beyond the general requirements stated in Sec.  
1.910, we are not prescribing details on aspects of the training such 
as its frequency, length, and subject matter. Given the diversity of 
food transportation operations, we do not intend to require that the 
entire industry use a single training approach. Training may vary in 
particular aspects, e.g., length, provided that it meets the 
requirements of this rule. Thus, firms conducting differing types of 
transportation operations may employ training that is tailored to their 
operations provided that it meets the requirements of this rule. A firm 
that does not transport temperature controlled foods need not train 
their employees and food handlers in practices for providing 
temperature control during transportation. Transporters of chemical 
food additives may exercise the same selectivity in designing training 
programs for their operations.
    (Comment 161) Some comments ask that we acknowledge in the final 
rule that industry training on food and feed safety systems will be 
acceptable and that we will not require that training be specific to 
this rule.
    (Response 161) If industry training programs not specifically 
designed to address the requirements of this rule, nonetheless meets 
the requirements of Sec.  1.910, such training would be acceptable 
under this rule. However, note that Sec.  1.910 prescribes that the 
training, among other things, address the responsibilities of the 
carrier under this rule.
    (Comment 162) A comment states that there will not be sufficient 
time or resources to train ``qualified individuals'' during the one 
year implementation period following the publication of the final rule. 
Some comments request that we establish guidelines for the development 
of standardized training materials. A comment requests that we develop 
standardized training programs that can be downloaded from our Web 
site, similar to the educational materials we have made available for 
food defense training and education.
    (Response 162) The term ``qualified individual'' was not used in 
the proposed rule. It is used in this final rule in connection with 
determinations that food is safe when an indication of a possible 
material failure of temperature control or other conditions that may 
render the food unsafe occurs during transportation (Sec.  
1.906(a)(6)). While the Preventive Controls rules for human and animal 
feed set minimum training requirements for qualified individuals, as 
that term is used in those regulations, no training or other standards 
are set in this regulation with regard to qualified individuals.
    With regard to training for carriers, small businesses will have 2 
years after the publication of the final rule to comply with its 
requirements. All other businesses subject to this rule will have 1 
year. We believe firms will be able to comply with the training 
requirements of this rule within their allotted timeframes given these 
size based compliance dates and given the relatively brief and readily 
accessible

[[Page 20154]]

nature of the training we envision. We have given additional 
consideration to the nature of training needed to raise awareness by 
carriers of food sanitation concerns and controls and have concluded 
that it can be accomplished in less than one hour. That is not to say 
that some carriers may not find it valuable to provide more detailed 
training to individuals, for example on specific duties, such as bulk 
container cleaning. But the training that is mandated as a minimum by 
Sec.  1.910(a) is intended to raise awareness rather than set out 
carrier-specific duties. It is our intention to develop and place on 
our Web site a course that can be downloaded or taken online that would 
meet the requirements of this provision. The model for this training 
effort is our on-line food defense training materials. We anticipate 
working with interested third-party alliances in the development of 
this material. Carriers would also be able to print a copy of a 
certificate of participation in the course to satisfy the training 
recordkeeping requirement of the rule (Sec.  1.910(b)). Participation 
in the course posted on FDA's Web site would not be mandatory. Training 
from other sources, or conducted in-house by carriers, may also meet 
the requirements of 1.910(a). Our intent is to provide a low cost 
(labor cost only) means of satisfying the requirement.
    (Comment 163) A comment asks whether we have considered having this 
training be a requirement to obtain a truck driver's license.
    (Response 163) A Commercial Driver's Licenses (CDL) is required to 
operate a tractor-trailer for commercial use. CDLs are issued by the 
States and are subject to requirements of DOT's Federal Motor Carrier 
Safety Administration. FDA has no authority to establish requirements 
for obtaining a CDL. Further, we believe that a requirement for safe 
food transportation training for all CDL holders would be unnecessarily 
burdensome, since many such drivers are not involved in transporting 
food.
    (Comment 164) Some comments express willingness to work with us and 
other carrier and shipper organizations to develop sanitary food 
transportation training. Several comments state that the Seafood HACCP 
Alliance could best serve this purpose since it already has an 
established history in providing training, and has sufficient 
stakeholder involvement and the infrastructure in place to design, 
develop, and deliver training.
    (Response 164) We commend the willingness of organizations to 
partner in developing sanitary food transportation training. Training 
alliances such as the Seafood HACCP Alliance have effectively 
functioned for this purpose in the past. We believe that a similarly 
constituted alliance would be useful for developing and promoting 
training for sanitary food transportation.

G. What record retention and other records requirements apply to 
shippers, receivers, loaders, and carriers engaged in transportation 
operations? (Sec.  1.912)

    We proposed that shippers and carriers: (1) Must retain all records 
required under this rule for a period of 12 months beyond a specified 
date when these records are used in their operations; (2) must retain 
all training records for a period of 12 months beyond when the person 
identified in the records continues to perform the duties for which the 
training was provided; (3) must make these records available to a duly 
authorized individual promptly upon oral or written request; (4) must 
keep required records as original records, true copies or as electronic 
records, which must be kept in accordance with part 11 (21 CFR part 
11); and (5) may store specified records offsite after 6 months 
following the creation of the record, if the records can be retrieved 
and provided onsite within 24 hours of requests for official review. We 
also specified that all records required by this rule are subject to 
the disclosure requirements of part 20 (21 CFR part 20). In table 10, 
we describe revisions to proposed Sec.  1.912 and following the table 
we respond to comments related to these provisions.

    Table 10--Sec.   1.912 What Record Retention and Other Records Requirements Apply to Shippers, Receivers,
                           Loaders, and Carriers Engaged in Transportation Operations?
----------------------------------------------------------------------------------------------------------------
              Proposed section                           Description                        Revision
----------------------------------------------------------------------------------------------------------------
1.912.......................................  Records requirements for          Add ``receiver'' and ``loader''
                                               shippers and carriers.            to be subject to certain
                                                                                 records requirements.
1.912(a)....................................  Records that shippers must        Split requirement into 2 parts:
                                               retain to demonstrate that they  (1) Requires shippers to retain
                                               provide information to carriers   records that demonstrate that
                                               as a regular part of their        they provide specifications and
                                               operations for 12 months beyond   operating temperatures to
                                               when the shipper may need to      carriers for 12 months beyond
                                               provide such information.         termination of the agreement
                                                                                 with the carriers
                                                                                (2) Requires shippers to retain
                                                                                 records of written agreements
                                                                                 and procedures required by
                                                                                 1.908(b)(3), (4), and (5) for a
                                                                                 period of 12 months beyond when
                                                                                 the agreements and procedures
                                                                                 are in use.
1.912(b)....................................  Carriers must retain certain      Removed reference to retention
                                               written agreements and records    of written agreements required
                                               of written procedures for 12      by 1.908(d)(2)(ii) and
                                               months beyond when the            redesignated 1.908(d) to (c).
                                               agreements and procedures are
                                               in use.
1.912(c)....................................  Carriers must retain training     Revised ``continues to perform''
                                               records for 12 months beyond      to ``stops performing''.
                                               when the person identified in
                                               records continues to perform
                                               the duties for which they were
                                               trained.
1.912(d)....................................  Requires persons subject to the   New provision in the final rule.
                                               rule to retain written
                                               agreements assigning tasks
                                               covered by the rule for 12
                                               months beyond the termination
                                               of the agreement.
1.912(e)....................................  Requires covered parties which    New provision in the final rule.
                                               operate under ownership or
                                               control of a single legal
                                               entity must retain records of
                                               their written procedures for 12
                                               months beyond when the
                                               procedures are in use.
1.912(f)....................................  Requires that cover parties make  Adds ``loaders'' and
                                               all records available to duly     ``receivers'' to this provision
                                               authorized individuals upon      Provision was proposed as
                                               request.                          1.912(d).

[[Page 20155]]

 
1.912(g)....................................  Records must be kept as original  Remove the requirement that
                                               records, true copies, or          electronic records must be kept
                                               electronic records.               in accordance with part 11 of
                                                                                 this chapter.
                                                                                Provision was proposed as
                                                                                 1.912(e).
1.912(h)....................................  Clarifies that electronic         New provision resulting from the
                                               records are exempt from the       change to 1.912(g).
                                               requirements of part 11.
1.912(i)....................................  Allows for offsite storage of     Remove ``after 6 months
                                               records after 6 months and        following the date that the
                                               clarifies that electronic         record was made'' limitation
                                               records are onsite if they are    for offsite storage of records.
                                               accessible from an onsite        Provision was proposed as
                                               location.                         1.912(f).
1.912(j)....................................  All records subject to            No change. Provision was
                                               disclosure requirements of part   proposed as 1.912(g).
                                               20.
----------------------------------------------------------------------------------------------------------------

    (Comment 165) Several comments assert that we should exempt 
sanitary food transportation electronic records from compliance with 
part 11 and instead should take a more practical and simpler approach 
to requiring the authentication of electronic records. Some of these 
comments assert that requiring compliance with part 11 would be overly 
burdensome and cost-prohibitive and that this requirement is 
unnecessary because it would not significantly benefit the public 
health and is disproportionate to the regulatory need. Other comments 
assert that few, if any, entities engaged in the transportation of food 
would be able to meet this requirement because of the complexities 
involved with complying with part 11.
    Some comments state complying with part 11 would mean that current 
electronic records and recordkeeping systems would have to be 
redesigned and would require the use of specialized and expensive 
software, which many small shippers, carriers and receivers might not 
be able to afford. Another comment states that compliance with the 
electronic records requirements in part 11 would be onerous for 
operations that currently use a combination of paper and electronic 
recordkeeping systems and that the effective integration of electronic 
recordkeeping systems throughout the food transportation chain might 
not be achievable given the diverse nature of the parties involved in 
the food transportation system and the different types of electronic 
systems that are currently used by the industry.
    One comment acknowledges the importance of requiring that firms 
have adequate safeguards in place to ensure that electronic records 
cannot be altered, but asks us to provide the transportation industry 
with the flexibility to allow it to continue using, or to begin using, 
any existing electronic recordkeeping system that accomplishes this 
goal without mandating complete compliance with the prescriptive 
requirements in part 11. According to these comments, allowing the 
transportation industry to use existing electronic recordkeeping 
systems would enable industry to achieve our stated electronic 
recordkeeping goals efficiently and cost-effectively. A related comment 
urges us to provide a clear statement that companies may use any 
electronic recordkeeping systems as long as they ensure that all 
records are valid, accurate, and cannot be surreptitiously altered even 
if those electronic recordkeeping systems do not meet the prescriptive 
requirements of part 11.
    (Response 165) We agree that redesigning large numbers of existing 
electronic records and recordkeeping systems would create a substantial 
burden disproportionate to the public health need. Therefore, we are 
providing in new Sec.  1.912(g) of this final rule that records that 
are established or maintained to satisfy the requirements of this rule, 
and that meet the definition of electronic records in Sec.  11.3(b)(6) 
are exempt from the requirements of part 11. We also are specifying 
that records that satisfy the requirements of this rule, but that also 
are required under other applicable statutory provisions or 
regulations, remain subject to part 11. The rule provides that parties 
covered by this rule may rely on existing records to satisfy the 
requirements of this rule, and this rule does not change the status 
under part 11 of any such records if those records are currently 
subject to part 11. We are also establishing a conforming change in 
part 11, as new Sec.  11.1(n), which says that part 11 does not apply 
to records required to be established or maintained by this rule, and 
that records that satisfy the requirements of this rule, but that also 
are required under other applicable statutory provisions or 
regulations, remain subject to part 11.
    Although we are not specifying that part 11 applies, we expect 
parties covered by this rule to take appropriate measures to ensure 
that records are trustworthy, reliable, and generally equivalent to 
paper records and handwritten signatures executed on paper.
    (Comment 166) Some comments assert that the 12 month record 
retention requirement in proposed Sec.  1.912(a) is unnecessary and 
burdensome. One comment states that the time and costs required to 
create and maintain records for this rule will far outweigh the 
benefits of collecting and storing the information. One comment states 
that requiring record retention for 12 months beyond the last date of 
the activity described by the record as set forth in proposed Sec.  
1.912(a) is confusing. The comment interprets the language of proposed 
Sec.  1.912(a) as requiring perpetual record retention activity for 
persons covered by this rule by continually adding an additional 12 
month record retention period beyond the latest requirement. The 
comment also states that the proposed requirement that carriers retain 
training records for a period of 12 months beyond when the person 
identified in such records continues to perform the duties for which 
the training was provided is confusing, and asks us to restate the 
requirement more clearly. The comment asks, for example, if a person 
receives a refresher training course 11 months after the initial 
training, and then receives another refresher training course 13 months 
later, all the while continuing to perform the duties for which the 
training was provided, how long must the original and refresher 
training records be retained?
    (Response 166) We are requiring that records be retained for a 
period 12 months beyond the last date of the activity described by the 
record, so that we can review the past practices of a shipper or 
carrier that may not currently be engaged in food transportation 
operations. Maintaining such records on

[[Page 20156]]

an ongoing basis will not be burdensome because the practices described 
in such records, e.g., vehicle cleaning practices, procedures for 
providing information to shippers and carriers, etc., are likely to be 
ongoing operating practices that change very little over time. We 
therefore do not believe that further clarification of Sec.  1.912(a) 
is necessary. With respect to refresher training, we would only expect 
records of the refresher training to be retained for our examination if 
such training was necessary for the person to continue to meet the 
training requirement of Sec.  1.910(a). For example, if a carrier 
previously only transported food that does not require temperature 
control for safety, e.g., was refrigerated strictly for quality 
purposes, and thus, not subject to this rule, but was beginning to 
transport shell eggs, it would be necessary to ensure that a vehicle 
operator was aware of the potential food safety problems and associated 
temperature control needs for shell egg transportation.
    (Comment 167) A few comments commend our ``practical approach'' of 
not proposing that carriers or shippers would have to maintain a 
``roomful of records'' documenting conditions for individual shipments. 
These comments state that while our generally practical approach has 
been conveyed to the food transportation industry repeatedly at FDA's 
public meetings, it was not discussed in detail in the preamble to the 
proposed rule. These comments encourage us to explain our regulatory 
philosophy in the preamble to this final rule in order to prevent 
deviations from our public statements in the future and to reinforce 
our intent. These comments also state that our field inspectors should 
be trained to understand that this regulation's recordkeeping 
requirements differ from the requirements under other FSMA regulations 
and that FDA inspectors should be trained not to ask for transportation 
records beyond those that are legally required under this final rule. A 
similar comment states that this rule is silent with respect to the 
retention of shipment records related to truck inspections, pre-cooling 
activities, and temperature monitoring, and asks us to make clear that 
the retention of such records is outside the scope of the rule.
    (Response 167) Some of these comments refer to statements that we 
made in public meetings (Refs. 29 and, 30) in Chicago, IL and College 
Park, MD regarding the proposed rule.
    In the Chicago meeting, for example, we stated: ``[A] carrier will 
have to provide information to shippers if it's a bulk carrier, about 
prior cargoes in its vehicle. We're not looking for a record of every 
prior cargo that was transported in every bulk vehicle the carrier 
operates. What we want to see is an SOP, that's the carrier's record . 
. . that states how it provides this information to the shipper.'' We 
further stated during the Chicago meeting that: [W]e're not looking for 
operational records that are going to fill a room up to the ceiling--
[for example,] time, temperature, strip chart recordings--for every 
transportation operation for refrigerated food or cleaning records for 
every bulk tanker, we're looking for a procedure from the carrier that 
describes how he will provide this information to the shipper.'' 
Finally, we also said during the Chicago public meeting that: ``[W]e've 
done all that we can to minimize the burden of this recordkeeping 
requirement, but enable us to verify that this information exchange, 
which we think is an important part of sanitary transportation 
practices, is taking place.'' We stated during the College Park public 
meeting that: ``[W]e are not looking for carriers to fill up some room 
with time-temperature strip chart recordings for every load of 
refrigerated food that they transport and show those records for every 
operation that they conduct to the FDA. We are looking for the carrier 
to, in the form of a record, provide FDA [with] records that 
demonstrate that they do conduct this information exchange with 
shippers, that they do provide, as a part of their operation, 
information about the maintenance of temperature control to shippers.'' 
We again emphasized during the College Park public meeting that we 
``tried to develop this recordkeeping provision in a way that minimizes 
the burden but recognizes the accountability of the carrier to 
demonstrate to shippers that they are transporting refrigerated foods 
or bulk foods under conditions that comply with requirements of the 
rule.'' Accordingly, these comments are correct in observing that the 
records retention requirements of this rule do not require carriers or 
shippers to maintain for our examination, records documenting 
conditions, such as temperature conditions, for individual shipments. 
Carriers may, however, choose to retain such information to provide to 
shippers upon request in accordance with Sec.  1.908(e)(2)(i).
    These comments also are correct in stating that this rule differs 
from other FSMA rules because this rule does not require the 
maintenance of records of ongoing transportation operations in the same 
way that some other FSMA rules require the retention of specific 
operating records. This rule, for example, does not mandate that 
persons covered by this rule must maintain monitoring records as does 
the FSMA preventive controls rules. We will ensure that our 
investigators are trained to understand the unique recordkeeping 
requirements of this rule.
    Finally, there are no requirements in this rule concerning the 
retention of individual shipment records for our examination related to 
truck inspections, or precooling and temperature monitoring activities. 
Shippers and carriers, however, may choose to retain such information 
for business purposes.
    (Comment 168) One comment states that the proposed rule requires 
carriers to demonstrate the temperature conditions that are maintained 
during transport, but fails to specify how long a carrier must maintain 
these temperature condition records.
    (Response 168) A carrier may, but is not required to, create 
records of temperature conditions maintained during the transportation 
of food to provide to a shipper or a receiver upon request pursuant to 
Sec.  1.908(e)(2)(i). This rule does not establish any retention time 
requirements for these optional temperature condition records.
    (Comment 169) Some comments state that the proposed requirements to 
store records onsite are contrary to accepted and effective 
recordkeeping practices. Some of these comments state that companies 
frequently keep records of food safety activities, as well as 
transportation, cleaning, and training records at their corporate 
offices and not at operating facilities and asks us to allow this 
practice to continue. These comments also state that there is little 
practical difference between maintaining records onsite at food 
transportation facilities versus maintaining them offsite, for example, 
at corporate offices, provided that they can be provided to duly 
authorized individuals promptly upon an oral or written request, that 
is, within 24 hours.
    (Response 169) We agree with this comment. Therefore, we have 
revised Sec.  1.912(h) of this final rule to allow offsite storage of 
all records, except for the written procedures required by Sec.  
1.908(e)(6)(i), provided that the records can be retrieved and made 
available to us within 24 hours of a request for official review. As 
proposed, we will continue to require that the written procedures 
required by Sec.  1.908(e)(6)(i) remain onsite as long as the 
procedures are in use in transportation operations. These written 
procedures comprise cleaning, sanitizing and inspection procedures for

[[Page 20157]]

vehicles and equipment, and we believe that they would normally be kept 
on site because they are used in operations at the site. We are not 
requiring that carriers maintain records of their actual cleaning, 
sanitizing and inspection operations they perform on vehicles and 
equipment. We anticipate that many records will be stored 
electronically and therefore will be accessible from an onsite food 
transportation facility.
    (Comment 170) A few comments state that it may be difficult for 
some carriers to promptly provide records, depending on what we mean by 
the term ``promptly.'' The comment provided an example of a small 
carrier such as a motor vehicle owner/driver who might own a single 
motor vehicle used to transport food, who may not carry required 
records (e.g., training records) while in transit and who might 
maintain the required records in a private residence. One of these 
comments asks us to apply reasonable and flexible records production 
timeframes in these circumstances.
    (Response 170) We anticipate that, to the extent feasible, we will 
carry out records examinations at a carrier's fixed business location. 
If we were to determine for any reason that it is necessary to request 
records for examination from a small carrier while the carrier is in 
transit, we would not necessarily expect the carrier to have the 
records in its immediate possession, and would provide the carrier with 
a reasonable amount of time to provide the records. Similarly, if for 
any reason we were to request records that a carrier maintains at a 
private residence, we would take into account the circumstances of the 
of the transportation operation as they may affect the carrier's 
ability to produce the records promptly.
    (Comment 171) One comment states that the records requirements of 
the proposed rule would be difficult to comply with because the 
shipper, carrier and receiver roles are not always easily identifiable 
when food is transported sequentially by more than one person between 
its point of origin and final destination.
    (Response 171) We understand that the sequential shipment of food 
by multiple persons might involve many persons such as brokers, rail 
carriers, motor carriers, distributors, etc., and that the roles of 
these persons may vary from one circumstance to another. Therefore, we 
have revised this final rule to better define the persons who are 
subject to the requirements of this rule. As we explained in our 
response to Comment 70, we have revised the definition of the term 
``shipper'' to clarify the scope of this definition. As we also 
discussed in our response to Comment 53, we have revised the definition 
of the term ``carrier'' to focus it more narrowly on the person who is 
responsible for the sanitary condition of the vehicle or transportation 
equipment used to transport food and to exclude from the definition, a 
person who is solely responsible for the movement of the vehicle or 
equipment. We believe the clarity we have added to the shipper, loader, 
carrier and receiver roles will make recordkeeping easier.
    (Comment 172) Some comments state that written agreements assigning 
duties in compliance with this rule to other persons, as discussed in 
our response to Comment 16, should be subject to the record keeping 
provisions of this rule.
    (Response 172) We agree. As we discussed in our response to Comment 
16, we expect that the parties would have a written contract as proof 
of their agreement. To enable us to determine which party has 
responsibility to fulfill a duty assigned by this rule, we are 
establishing in Sec.  1.912(b) that written agreements assigning duties 
in compliance with this rule are subject to the record keeping 
provisions of this rule.
    (Comment 173) Some comments express concern that this rule's 
recordkeeping requirements will pose a burden on businesses. One of 
these comments states that this rule adds to other FDA records 
requirements. Another comment questioning the necessity of the records 
requirements of this rule, states that food transportation vehicles are 
pre-cooled and inspected before they are loaded and if they do not meet 
the required sanitary standards, they are refused or sent to be washed 
out and that this information is recorded in the shipping paperwork and 
can be provided to shippers, receivers, and FDA if necessary. Another 
comment acknowledges that it is important for a carrier to be able to 
demonstrate that a process is in place for training, sanitizing and 
cleaning, but asserts that retaining records that document these 
activities for one year would not serve any meaningful food 
transportation safety purpose.
    (Response 173) We have made several revisions to this final rule in 
response to comments that we received on the proposed rule that will 
lessen the recordkeeping requirements for persons who are subject to 
the rule (see Comment 129, Comment 149, Comment 165, and Comment 169). 
Section 7202(b) of the 2005 SFTA requires us to issue a regulation that 
``require[s] 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.'' Section 7202(c) also states that we must 
prescribe practices that we deem to be appropriate and necessary 
relating to, among other things, recordkeeping. As we have explained 
throughout the preamble to this final rule, we have determined that the 
records provisions in this final rule are appropriate for this purpose 
and required of us by our statutory mandate.
    (Comment 174) One comment asks us to codify all of the 
recordkeeping requirements that apply to both the manufacture and 
transportation of animal feed in one location for ease of accessibility 
by the animal industry.
    (Response 174) We have issued this rule for the sanitary 
transportation of human and animal food under the 2005 SFTA and the 
preventive controls rule for animal food under the FSMA, which are two 
separate grants of statutory authority given to us by Congress. These 
rules and their records requirements have been codified in distinct 
parts of Title 21 of the Code of Federal Regulations to reflect these 
two different authorizing statutes. However, FDA maintains a Web site 
dedicated to the FSMA, which can be found at https://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm, from which industry can quickly 
access information about this sanitary food transportation rule and the 
other FSMA rules.
    (Comment 175) One comment notes that records that are required by 
our seafood and juice HACCP rules are exempt from public disclosure 
under the Freedom of Information Act (FOIA), and asks us to similarly 
exempt the records required by this final rule from public disclosure. 
The comment's concern is that the records required by this rule may 
contain proprietary and confidential information (e.g., contracts 
between carriers and shippers under proposed Sec.  1.908(d)(2)(ii)), 
may contain information that could be used to compromise food safety 
measures (e.g., carrier's written procedures for cleaning and 
inspecting vehicles and transportation equipment), and could be 
misunderstood if taken out of context.
    (Response 175) We first note that in the rulemaking for the seafood 
and juice HACCP rules we did not state that records required by these 
rules are exempt from public disclosure. In this regard, the Agency 
concluded in the seafood HACCP final rule (60 FR 65096 at 65138), that 
HACCP plans, as a general rule, meet the definition of trade

[[Page 20158]]

secret information, and thus, even if these plans are in Agency files, 
they likely would not be available under FOIA. However, because FDA is 
bound by FOIA and the Agency's implementing regulation in 21 CFR part 
20, the Agency is unable to exclude categorically all HACCP records in 
Agency files from public disclosure.
    We would determine whether records required by this rule that we 
copy are either publicly disclosable or protected from public release 
under the FOI Act on a case-by-case basis. We copy records on a case-
by-case basis as necessary and appropriate. We primarily intend to copy 
such records if the preliminary assessment by our investigator during a 
routine inspection is that regulatory followup may be appropriate 
(e.g., if these records demonstrate that cleaning procedures to 
maintain vehicles in appropriate sanitary condition are not being 
followed in a food transportation operation). We may consider it 
necessary to copy records when, for example, our investigators may need 
assistance in reviewing a certain record from relevant experts in 
headquarters. If we are unable to copy the records, we would have to 
rely solely on our investigators' notes and reports when drawing 
conclusions. In addition, copying records will facilitate followup 
regulatory actions. Even in these circumstances, however, certain 
information in the records could be considered confidential within the 
scope of the FOI Act and would be redacted from any records that would 
otherwise be publicly disclosable.

H. Waivers (Sec. Sec.  1.914-1.934)

    In table 11, we describe revisions to proposed Sec. Sec.  1.914 to 
1.934 and following the table we respond to comments related to these 
provisions.

                                  Table 11--Sec.  Sec.   1.914 to 1.934 Waivers
----------------------------------------------------------------------------------------------------------------
              Proposed section                           Description                        Revision
----------------------------------------------------------------------------------------------------------------
1.914(a) and (b)............................  Under what circumstances will     Replaced ``FDA'' with ``we''.
                                               FDA waive a requirement of this
                                               subpart?
1.916.......................................  When will FDA consider whether    Replaced ``FDA'' with ``we''.
                                               to waive a requirement of this
                                               subpart?
1.918(a) and (b)............................  What must be included in the      No change.
                                               Statement of Grounds in a
                                               petition requesting a waiver?
1.920.......................................  What information submitted in a   No change.
                                               petition requesting a waiver or
                                               submitted in comments on such a
                                               petition is publicly available?
1.922.......................................  Who will respond to a petition    No change.
                                               requesting a waiver?.
1.924(a)-(d)................................  What process applies to a         No change.
                                               petition requesting a waiver?.
1.926.......................................  Under what circumstances may FDA  Replaced ``FDA'' with ``we''.
                                               deny a petition requesting a
                                               waiver?
1.928.......................................  What process will FDA follow      Replaced ``FDA'' with ``we''.
                                               when waiving a requirement of     Replaced ``FDA'' with ``our''.
                                               this subpart on FDA's own
                                               initiative?
1.930.......................................  When will a waiver granted by     Replaced ``granted by FDA'' with
                                               FDA become effective.             ``that we grant''.
1.932.......................................  Under what circumstances may FDA  Replaced ``FDA'' with ``we''.
                                               modify or revoke a waiver?
1.934(a)-(c)................................  What procedures apply if FDA      Replaced ``FDA determines'' with
                                               determines that a waiver should   ``we determine''.
                                               be modified or revoked?
----------------------------------------------------------------------------------------------------------------

    (Comment 176) A comment asks that we clarify how we would waive 
requirements if we determine that the waiver will not result in the 
transportation of food under conditions that would be unsafe for human 
or animal health and that is in the public interest, and how we would 
communicate these waivers to state agencies.
    (Response 176) In Sec. Sec.  1.924 and 1.928 of the proposed rule, 
we outlined the processes we will follow when waiving a requirement of 
this subpart, depending on whether the waiver is granted in response to 
a submitted petition or on our own initiative. In both cases, we will 
publish a notice in the Federal Register setting forth the waiver and 
the reasons for such waiver. We believe this explanation is clear; 
therefore, we are retaining the language in Sec. Sec.  1.924 and 1.928 
in this final rule. Additionally, publication in the Federal Register 
provides notice to all interested parties, including State and Tribal 
agencies.
    (Comment 177) Some comments support our proposal to include in the 
final rule a petition process whereby we can grant a waiver from the 
proposed requirements of this rule. Additionally, a few comments urge 
us to not make such a petition too onerous or burdensome for 
individuals, small shippers, and owner/operator carriers and to provide 
lenience and guidance for such situations.
    (Response 177) We agree that we should allow a petition process to 
grant waivers from the requirements of this rule. In Sec.  1.916 of the 
proposed rule, we stated that we will consider whether to waive a 
requirement of this rule on our own initiative or on a petition 
submitted under 21 CFR 10.30. In proposed Sec.  1.918 we outlined what 
must be included in the Statement of Grounds in the petition. And in 
proposed Sec.  1.924 we outlined the process that will apply to a 
petition requesting a waiver. We do not believe that the petition 
described in Sec.  10.30, the Statement of Grounds described in Sec.  
1.918, or the process described in Sec.  1.924 is onerous or burdensome 
and, therefore, are retaining the language in these sections in the 
final rule. We do not plan to publish guidance on the petition itself, 
since it is explained in detail in 21 CFR 10.30.
    (Comment 178) A comment strongly urges that we issue public notice 
of potential waivers and petitions for waivers in the Federal Register 
and allow public comment on each proposed waiver. The comment states 
that our proposed system of granting waivers for some sanitary 
transportation requirements without first soliciting public comment is 
inconsistent with the FD&C Act and the Administrative Procedures Act 
(APA), since the FD&C Act requires the Secretary to publish waivers and 
any reasons for the waiver in the Federal Register (21 U.S.C. 
350e(d)(2)). The comment states that this demonstrates Congress's 
intent to have the public involved in the waiver process and notes that 
FDA itself recognized that public comment may be necessary to inform 
its determination

[[Page 20159]]

whether to grant a waiver (79 FR 7006 at 7029).
    (Response 178) We will consider whether to waive a requirement of 
this subpart in one of two ways: (1) On a petition submitted under 21 
CFR 10.30 or (2) on our own initiative. For a filed petition, Sec.  
1.924(b) states that we will publish a notice in the Federal Register 
requesting information and views on the petition, including information 
and views from persons who could be affected by the waiver if the 
petition were to be granted. For waivers to be established on our own 
initiative, Sec.  1.928 states that we will publish a notice in the 
Federal Register setting forth the waiver and the reasons for such 
waiver. We disagree that our system of granting waivers for some 
sanitary transportation requirements without first soliciting public 
comment is inconsistent with the FD&C Act and the APA. As we discussed 
in the proposed rule (79 FR 7006 at 7028), when we have determined that 
a waiver is appropriate in accordance with the standard set forth in 
section 416(d)(1) of the FD&C Act and proposed Sec.  1.914, we may 
grant a waiver without first soliciting public comment. We have 
concluded that this process is sufficient for us granting a waiver on 
our own initiative because it is the process set forth in section 
416(d)(2) of the FD&C Act.
    (Comment 179) Some comments recommend that we expedite written 
responses to waiver petitions and include in the final rule a timeframe 
for our decision on a petition (e.g., 180 days) and steps to be taken 
if the deadline is missed.
    (Response 179) We disagree with these comments. In proposed Sec.  
1.924, we stated that the procedures set forth in 21 CFR 10.30 govern 
our response to a petition requesting a waiver. 21 CFR 10.30 outlines 
the petition process and states that we will respond to the petitioner 
within 180 days of receipt of the petition. 21 CFR 10.30 does not 
address steps to be taken if the 180-day timeframe is missed.
    (Comment 180) Some comments request that we establish a waiver 
application process that resembles the process for granting a variance 
under the proposed FSMA produce safety regulation and ensures 
engagement with the applicant. One of the comments suggests that this 
process provide an avenue for an industry or a person to request a 
waiver without the involvement of a state or foreign government. These 
comments also state that the process should include an opportunity to 
re-obtain a revoked waiver after a period of time to incentivize long-
term commitments to food safety improvement.
    (Response 180) The process for granting a variance under the FSMA 
produce safety rule is very similar to the waiver petition process 
described in Sec. Sec.  1.914 to 1.934 of this final rule. Both require 
the submission of a petition under 21 CFR 10.30, and both require that 
we publish a notice in the Federal Register requesting information and 
views on the filed petition. Also, in both cases, we will respond to 
the petitioner in writing and also will make public a notice on our Web 
site announcing our decision to either grant or deny the petition. Much 
of the rest of the processes are similar, as well. Both ensure our 
engagement with the applicant by requiring us to provide a written 
response to the applicant. Additionally, the process in this final rule 
does not require involvement of a state or foreign government. Finally, 
while the waiver petition process doesn't specifically address the 
opportunity to re-obtain a revoked waiver, it does not preclude an 
interested party from reapplying for a revoked waiver using the 
petition process described in this final rule.
    (Comment 181) Some comments request clarification regarding whether 
a waiver can be revoked in whole or part from the group to which it was 
granted. A few comments suggest that we develop a policy that would 
allow us to revoke a waiver from a single ``bad actor,'' even when the 
waiver has been granted to an entire industry. The comments state that 
by doing so, each member of the industry still maintains individual 
responsibility for ensuring compliance.
    (Response 181) We outlined the process we will follow for 
modification and revocation of waivers in Sec. Sec.  1.932 and 1.934 of 
the proposed rule. Specifically, we stated in Sec.  1.932 that we may 
modify or revoke a waiver if we determine that the waiver could result 
in the transportation of food under conditions that would be unsafe for 
human or animal health or that the waiver could be contrary to the 
public interest. We believe the language in Sec. Sec.  1.932 and 1.934 
is clear and, therefore, are retaining it in the final rule. We do not 
agree that we should establish a policy for revoking a waiver from a 
single firm. The Sanitary Food Transportation Act of 2005 states that 
``the Secretary may waive any requirement under this section, with 
respect to any class of persons, vehicles, food, or nonfood products . 
. . .'' Since the SFTA gives FDA the authority to issue waivers to 
cover any class of persons, vehicles, food, or nonfood products, we 
believe that revocation of a waiver must also cover that same class of 
persons, vehicles, food, or nonfood products to which it was issued and 
not a subset thereof. Nonetheless, FDA can take appropriate action 
against an individual firm, such as described by this comment, if the 
firm fails to comply with the requirements of this rule.
    (Comment 182) A comment urges us to adopt appropriate provisions in 
the regulation governing waivers to protect against the disclosure of 
confidential business information of shippers, carriers, and receivers.
    (Response 182) We have adopted appropriate provisions in this 
regulation related to protection of confidential information. Proposed 
Sec.  1.920 states that we will presume that information submitted in a 
petition requesting a waiver and comments submitted on such a petition 
does not contain information exempt from public disclosure under 21 CFR 
part 20 and would be made public as part of the docket associated with 
this request. As we stated in the proposed rule, we do not believe that 
information exempt from disclosure under 21 CFR part 20 is the type of 
information that we are requiring to be submitted in such a petition or 
that would be relevant in any comments submitted on such a petition. We 
will publicly disclose a petition for waiver or comments on such a 
petition unless information in those documents falls within the 
exemption for confidential commercial or trade secret information in 21 
CFR part 20.
    (Comment 183) A few comments suggest that we provide a window of 60 
days for industry to come into compliance with the regulation when a 
waiver is revoked. The comments state that regulators could increase 
food safety surveillance of the product or industry during this short 
time.
    (Response 183) We disagree with these comments. In proposed Sec.  
1.934(a)(2) we stated that we will publish a notice of our 
determination that a waiver should be revoked in the Federal Register. 
We believe that this will serve as a notification to the affected 
industry that we are considering revocation of the waiver and will 
allow affected parties to plan for changes, should the waiver, in fact, 
be revoked. Therefore, we are retaining this language in the final 
rule. After considering written comments on the revocation notice, we 
will publish our decision in the Federal Register. The effective date 
of the revocation will be the date of publication of the notice.

[[Page 20160]]

V. Effective and Compliance Dates

A. Effective and Compliance Dates for Part 1, Subpart O

    We proposed that any final rule based on proposed part 1, subpart O 
become effective 60 days after its date of publication in the Federal 
Register, with staggered compliance dates (79 FR 7006 at 7032). 
Businesses other than small businesses would have 1 year from the date 
of publication of the final rule to comply with the rule, whereas small 
businesses would have 2 years to comply with the rule.
    After considering the following comments addressing the proposed 
compliance dates for this rule, we are establishing the effective and 
compliance dates as proposed.
    (Comment 184) One comment encourages us to allow a phased-in 
timeframe for compliance with this rule because companies will need 
time to develop written protocols and train company personnel. One 
comment states that it is not reasonable to expect the industry to be 
in compliance in 1 or 2 years, given the cultural changes required by 
the proposed regulation. One comment states that the 2-year period for 
compliance for small businesses seems overly generous because many, if 
not most, of the requirements of this rule should already be in place 
under existing rules and regulations. A comment states that it will be 
difficult to implement phased-in compliance dates because inspectors 
will not be able to determine a business' size when performing single 
vehicle inspections. The comment recommends that we establish a single 
compliance date that is possible for all businesses to meet.
    (Response 184) It is our general practice for this type of 
rulemaking, which does not address a public health emergency or other 
matter that would require a uniform compliance date for all businesses, 
to consider business size in establishing timeframes for businesses to 
come into compliance with the rule. After considering these comments, 
we are retaining the proposed compliance dates for this rule, i.e., 1 
year after the date of publication of the final rule for businesses 
other than small businesses, and 2 years after the date of publication 
of the final rule for small businesses, because we believe that they 
are reasonable for businesses subject to this rule. We do expect that 
questions, such as how would an inspector determine a business' size, 
may arise during the implementation of this rule. We intend to work 
closely with the food transportation industry, extension and education 
organizations, and State, local, and tribal partners to facilitate 
implementation of this rule. Furthermore, this rule is based upon 
industry best practices already in place, which should minimize the 
time for industry to come into compliance.

B. Effective Dates for Conforming Changes

    The conforming amendment to part 11 adds a reference to the scope 
of part 11 that the records required under part 1, subpart O are not 
subject to part 11. This conforming amendment is effective on June 6, 
2016, the same date as the effective date of part 1, subpart O. We are 
not establishing compliance dates for these conforming amendments. As a 
practical matter, compliance dates will be determined by the dates for 
compliance with part 1, subpart O.

VI. Executive Order 13175

    In accordance with Executive Order 13175, FDA has consulted with 
tribal government officials. A Tribal Summary Impact Statement has been 
prepared that includes a summary of tribal officials' concerns and how 
FDA has addressed them (Ref. 31). Persons with access to the Internet 
may obtain the Tribal Summary Impact Statement at https://www.fda.gov or 
at https://www.regulations.gov. Copies of the Tribal Summary Impact 
Statement also may be obtained by contacting the person listed under 
FOR FURTHER INFORMATION CONTACT.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety effects, distributive impacts, and equity). We believe that 
this final rule is a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. This final rule defines small business as one subject to this 
rule employing fewer than 500 full-time equivalent employees except 
that for carriers by motor vehicle that are not also shippers and/or 
receivers, this term would mean a business subject to this rule having 
less than $27,500,000 in annual receipts. The Agency concludes that the 
final rule will have a significant economic impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $144 
million, using the most current (2014) Implicit Price Deflator for the 
Gross Domestic Product. FDA expects this final rule to result in a 1-
year expenditure that would meet or exceed this amount.
    The final analysis conducted in accordance with these Executive 
orders and statutes is available in the docket for this rulemaking 
(Ref. 24) and at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses.

VIII. How does the Paperwork Reduction Act of 1995 apply to this final 
rule?

    This final rule contains information collection requirements that 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3521) (PRA). A description of these provisions is given 
in the following paragraphs with an estimate of the annual 
recordkeeping and reporting burdens. Included in the burden estimate is 
the time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    Title: Sanitary Transportation of Human and Animal Food.
    Description: This new collection of information will be performed 
by shippers, receivers, loaders, and carriers of human and animal food. 
The records requirements of this final rule include records pertaining 
to: Sanitary specifications, temperature during transportation 
operations, cleaning of bulk vehicles, training, and written 
procedures. In addition, this final rule includes submission 
requirements pertaining to waiver petitions, when appropriate.
    We have concluded that recordkeeping and submissions are necessary 
for the success of the food transportation operation. Records of 
actions taken due to each requirement are essential for manufacturers 
to

[[Page 20161]]

implement this rule effectively. Further, records and reports are 
essential for us to be able to determine whether a firm is in 
compliance with the rule.

Analysis of Burden Estimates Resulting From This Final Rule

    Description of Respondents: Shippers, receivers, loaders, and 
carriers of human and animal food.
    In the following paragraphs, we describe and respond to the 
comments that we received on the PRA for our 2014 proposed rule. We 
numbered each comment to help distinguish between different comments. 
The number assigned to each comment is purely for organizational 
purposes and does not signify the comment's value, importance, or the 
order in which it was received.
    (Comment 185) We received many comments regarding the burden of 
proposed Sec.  1.908(d)(2)(i), which required demonstration of 
temperature conditions during a shipment. The comments stated that 
these burdens can include adoption of a method of monitoring and 
recording temperatures during shipment, purchase of equipment, 
implementation of those systems, and the costs of downloading data. One 
comment stated that, although most carriers have temperature data on 
temperature-controlled shipments, this data is not readily available 
and easily retrievable without incurring significant costs. 
Furthermore, as another comment stated, if the proposed requirement 
were finalized, far more than the 1 percent of industry estimated in 
the economic analysis would have to incur these costs. Another comment 
stated that, while ``reefer'' trailers are generally equipped with 
thermometers, they do not ordinarily create any kind of permanent 
printout record to be shown to the receiver. The comment emphasized 
that any requirement to have this would put unnecessary burdens on 
industry, particularly small firms. One comment stated that the current 
practice is for such records to be provided only if there is an 
indication of a problem (i.e., signs of temperature abuse) upon receipt 
of the load.
    (Response 185) We acknowledge the lack of data available to us when 
estimating the cost of this proposed requirement. However, as a result 
of public comment, this requirement has been amended (final Sec.  
1.908(e)(2)(i)) to require this demonstration of temperature conditions 
only when the carrier has agreed by contract with the shipper to assume 
this responsibility, and only if requested by the shipper or receiver 
and in a way agreeable to the shipper and carrier, which can include 
measurements of ambient temperature. We believe this is aligned with 
current industry practices and is not estimated to represent new cost 
to industry.
    (Comment 186) One commenter stated that proposed Sec.  1.908(d)(4), 
requiring carriers offering bulk vehicles for food transportation to 
provide written documentation to the shipper that identifies the three 
previous cargoes transported in the vehicle, would be overly 
burdensome. Another comment stated that the estimated burden of this 
requirement did not include the cost of implementing industry-wide 
software changes for railroads, as tracking this information is not 
current industry practice.
    (Response 186) These comments did not provide any data to allow us 
to calculate this burden, and we acknowledge the simplicity of our 
assumptions in the estimations of the cost related to this provision. 
However, in response to comments on the proposed rule, this provision 
has been amended (final Sec.  1.908(e)(4)) to require carriers to 
provide information identifying the last previous cargo only when they 
have agreed by contract with the shipper to assume this responsibility, 
and only if requested by the shipper. We believe this provision is 
aligned with current industry practice. No new burden is estimated for 
this information collection.
    (Comment 187) A commenter stated that proposed Sec.  1.908(d)(5), 
which required carriers to provide information to shippers describing 
the most recent cleaning of bulk vehicles, would be beyond the current 
capabilities of railroads. The comment stated that compliance with this 
requirement would likely require expensive investments to track this 
information, as this is not current industry practice.
    (Response 187) This comment did not provide any data that would 
allow us to estimate this burden. However, in response to comments on 
the proposed rule, this provision has been amended (final Sec.  
1.908(e)(5)) to require information describing the most recent cleaning 
of bulk vehicles only when the carrier has agreed by contract with the 
shipper to assume this responsibility, and only if requested by the 
shipper. This provision is believed to be aligned with current industry 
practice. No new burden is estimated for this information collection.
    (Comment 188) One commenter stated that requiring firms to retain 
records for 1 year would not benefit those along the supply chain and 
would be unnecessarily burdensome.
    (Response 188) This comment does not describe how the 12-month 
retention requirement would be more burdensome. This final rule reduces 
the total number of records related to sanitary food transport, which 
will reduce new burden to industry. Furthermore, the codified provides 
a wide range of options on how these records must be kept. We estimate 
that firms will maintain electronic records, which further reduces 
burden.
    (Comment 189) One comment expressed appreciation regarding the 
ability of industry to diverge from certain proposed requirements, such 
as those for bulk shipments, by contractual agreement. This comment 
stated that reflects a practical understanding of the way business is 
conducted and how flexibility is essential because of the highly 
complex nature of the transportation chain. This comment went on to 
state that FDA should permit flexibility to allow businesses to enter 
into contractual agreements allocating the responsibilities for 
shippers, carriers, and receivers to other parties.
    (Response 189) While this comment did not address the PRA of the 
proposed rule specifically, it does allow us to estimate that 
contractual agreements, such as those addressed in Sec.  1.908(b)(3), 
are common business practice. No additional information collection 
burden to industry is estimated for such agreements.
    FDA estimates the burden of this collection of information as 
follows:
    The total one-time estimated burden imposed by this collection of 
information is 254,923 hours (228,832 recordkeeping hours + 144 
submission hours + 25,947 third-party disclosure hours). The total 
annual estimated burden imposed by this collection of information is 
120,342 hours (120,163 recordkeeping hours + 48 submission hours + 113 
third-party disclosure hours). There are no capital costs or operating 
and maintenance costs associated with this collection of information. 
FDA estimates that firms will be able to fulfill recordkeeping 
requirements with existing record systems; that is, FDA estimates that 
it will not be necessary for firms involved in food transportation to 
invest in new recordkeeping systems.
    One-time burdens are estimated for establishing written procedures 
regarding integrated transportation operations, written procedures for 
transportation operations with respect to sanitary condition of 
vehicles and equipment, previous cargoes, and adequate temperature 
control; written procedures for cleaning and sanitizing; procedures for 
use of bulk vehicles; training; notification of operating temperature 
and written sanitary

[[Page 20162]]

specifications, disclosure of information; and submission of waiver 
petitions, when appropriate. Annual burdens are related to disclosure 
of written sanitary specifications, operating temperatures, and 
training records.
    First-year and annual burdens related to recordkeeping requirements 
are presented in table 12. In the economic analysis of this final rule, 
cost estimations were estimated based on a percentage of, for example, 
shippers that may have to change behavior as a result of this final 
rule, or shipments that would have new records associated with them. 
Calculating percentages of firms or shipments often resulted in 
fractions; these numbers were rounded to the nearest whole number to be 
presented in the analysis. Therefore, any discrepancies in table 12 are 
attributable to rounding.
    It is estimated that about 343 recordkeepers will each spend 2 
hours (one-time) developing written procedures related to integrated 
transportation operations, as required by Sec.  1.908(a)(4). Therefore, 
343 x 2 = 686 (686.13) one-time hours, as presented in line 1.
    The one-time cost of developing written procedures to ensure 
sanitary condition of vehicles and equipment, as required by Sec.  
1.908(b)(3), is estimated at the shipper level. It is estimated that 
these written procedures are relatively simple and easy to assemble, 
and that one recordkeeper for about 4,483 firms will spend 0.5 hour 
adjusting current practices with respect to this requirement. 
Therefore, 0.5 hours x 4,483 = 2,242 (2,241.69) one-time hours for 
Sec.  1.908(b)(3), as shown in line 2.
    The one-time cost of developing written procedures to ensure that 
previous cargo does not make food unsafe, as required by Sec.  
1.908(b)(4), is estimated at the shipper level. It is estimated that 
these written procedures are relatively simple and easy to assemble, 
and that one recordkeeper for about 4,483 firms will spend 0.5 hour 
adjusting current practices with respect to this requirement. 
Therefore, 0.5 hours x 4,483 = 2,242 (2,241.69) one-time hours for 
Sec.  1.908(b)(4), as shown in line 3.
    The one-time cost of developing written procedures to ensure that 
food is transported under adequate temperature control, as required by 
Sec.  1.908(b)(5), is estimated at the shipper level. It is estimated 
that these written procedures are relatively simple and easy to 
assemble, and that one recordkeeper for about 4,483 firms will spend 
0.5 hour aligning current practices with this requirement. Therefore, 
0.5 hours x 4,483 = 2,242 (2,241.69) one-time hours for Sec.  
1.908(b)(5), as shown in line 4.
    The one-time cost of development of written procedures related to 
cleaning and sanitation, as required by Sec.  1.908(e)(6)(i), is 
estimated at the carrier level. It is estimated that one recordkeeper 
for about 37,249 firms will spend 2 hours developing written 
procedures. Therefore, 2 hours x 37,249 = 74,498 (74,498.48) one-time 
hours for Sec.  1.908(e)(6)(i), as shown in line 5.
    The one-time cost of development of written procedures related to 
bulk vehicles, as required by Sec.  1.908(e)(6)(iii), is estimated at 
the bulk carrier level. It is estimated that one recordkeeper for about 
6,713 firms will spend 2 hours developing written procedures. 
Therefore, 2 hours x 6,713 = 13,426 (13,426.48) one-time hours for 
Sec.  1.908(e)(6)(iii), as shown in line 6.
    The one-time cost of establishing training records, as required by 
Sec.  1.910(b), is estimated at the employee level. It is estimated 
that one recordkeeper will establish a record for about 1,668,698 
workers, and this will take 5 minutes (0.08 hours) for each worker. 
Therefore, 0.08 hour x 1,668,698 = 133,496 (133,495.86) one-time hours 
for Sec.  1.910(b), as shown in line 7.
    The total one-time hourly recordkeeping burden is 228,832 
(228,832.02) hours.
    The annual cost of training records, as required by final Sec.  
1.910(b), is estimated at the worker level. It is estimated that one 
recordkeeper for each of about 1,502,032 workers will spend 5 minutes 
(0.08 hour) minutes completing records related to annual training (the 
time spent training is estimated separately and not included in this 
PRA analysis). We believe recordkeeping will be very simple and can 
consist of, for example, printing off a certificate of completion. 
Therefore, 0.08 hour x 1,502,032 workers = 120,163 (120,162.59) annual 
hours for Sec.  1.910(b), as shown in line 8. Therefore, the annual 
hourly recordkeeping burden is 120,163 hours.

                           Table 12--First Year Only and Annual Recordkeeping Burdens
----------------------------------------------------------------------------------------------------------------
                                                    First year
         21 CFR section              Number of     frequency of    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
----------------------------------------------------------------------------------------------------------------
                                          First Year Only Hourly Burden
----------------------------------------------------------------------------------------------------------------
1. Written Procedures for                    343               1             343               2             686
 Integrated Operations                                                                                  (686.13)
 (1.908(a)(4))..................
2. Written procedures to ensure            4,483               1           4,483             0.5           2,242
 sanitary condition of vehicles                                                                       (2,241.69)
 (1.908(b)(3))..................
3. Written procedures to ensure            4,483               1           4,483             0.5           2,242
 that previous cargo does not                                                                         (2,241.69)
 make food unsafe (1.908(b)(4)).
4. Written procedures to ensure            4,483               1           4,483             0.5           2,242
 that food is transported under                                                                       (2,241.69)
 adequate temperature control
 (1.908(b)(5))..................
5. Written procedures, cleaning           37,249               1          37,249               2          74,498
 and sanitation (1.908(e)(6)(i))                                                                     (74,498.48)
6. Written procedures, bulk                6,713               1           6,713               2          13,426
 vehicles (1.908(e)(6)(iii))....                                                                     (13,426.48)
7. Training Records (1.910(b))..       1,668,698               1       1,668,698            0.08         133,496
                                                                                                    (133,495.86)
                                 -------------------------------------------------------------------------------
    First Year Only Hourly                                                                               228,832
     Recordkeeping Burden.......                                                                    (228,832.02)


[[Page 20163]]


----------------------------------------------------------------------------------------------------------------
                                                    First year
         21 CFR section              Number of     frequency of    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
----------------------------------------------------------------------------------------------------------------
                                             Recurring Hourly Burden
----------------------------------------------------------------------------------------------------------------
8. Training Records (1.910(b))..       1,502,032               1       1,502,032            0.08         120,163
                                                                                                    (120,162.59)
                                 -------------------------------------------------------------------------------
    Annual Hourly Recordkeeping   ..............  ..............  ..............  ..............         120,163
     Burden.....................                                                                    (120,162.59)
----------------------------------------------------------------------------------------------------------------

    The one-time and annual hourly burdens related to submission of 
waiver petitions (Sec.  1.914) are presented in table 13. This final 
rule refers to previously approved collections of information found in 
FDA regulations. These collections of information are subject to review 
by OMB under the PRA. The collections of information in Sec.  10.30 
have been approved under OMB control number 0910-0183 (General 
Administrative Procedures: Citizen Petitions; Petition for 
Reconsideration or Stay of Action; Advisory Opinions).
    In the first year, it is estimated that one recordkeeper from each 
of a total of six firms will each spend 24 hours submitting a waiver 
petition to FDA (per the estimate for the petition process in Sec.  
10.30, approved and estimated under OMB control number 0910-0183 as 24 
hours per submission). Therefore, 6 waiver petitions x 24 hours = 144 
one-time hours for Sec.  1.914, as shown in line 1. Annually, it is 
estimated that one recordkeeper from each of a total of two firms will 
spend 24 hours submitting a waiver petition to FDA. Therefore, 2 waiver 
petitions x 24 hours = 48 annual hours for Sec.  1.914, as shown in 
line 2.

                                Table 13--First Year and Annual Submission Burden
----------------------------------------------------------------------------------------------------------------
                                                    First year
         21 CFR section              Number of     frequency of    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
----------------------------------------------------------------------------------------------------------------
                                   Estimated First Year Only Submission Burden
----------------------------------------------------------------------------------------------------------------
1. Waiver Petitions (1.914).....               6               1               6              24             144
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
                                                    First year
         21 CFR section              Number of     frequency of    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
----------------------------------------------------------------------------------------------------------------
                                       Estimated Annual Submission Burden
----------------------------------------------------------------------------------------------------------------
2. Waiver Petitions (1.914).....               2               1               2              24              48
----------------------------------------------------------------------------------------------------------------

    The one-time and hourly burdens related to third-party disclosures 
are presented in table 14. The one-time cost of developing written 
sanitary specifications necessary for transportation, as required by 
Sec.  1.908(b)(1), is estimated at the shipper level. It is estimated 
that one recordkeeper for each of about 10,163 firms will spend 30 
minutes developing written sanitary specifications. Therefore, 0.5 hour 
x 10,163 firms = 5,082 (5,081.57) one-time hours for Sec.  1.908(b)(1), 
as shown in line 1.
    The one-time cost of developing initial notifications of operating 
temperature, as required by Sec.  1.908(b)(2), is estimated at the 
shipper level. It is estimated that one recordkeeper for each of about 
5,646 firms will spend 30 minutes (0.5 hour) developing these 
notifications. Therefore, 0.5 hour x 5,646 firms = 2,823 (2,823.13) 
hours, as shown in line 2.
    The one-time cost of establishing records pertaining to disclosure 
of information, as required by Sec.  1.912(a), is estimated at the firm 
level. It is estimated that one recordkeeper will establish a record at 
a total of about 36,084 firms, and this will take 30 minutes (0.5 hour) 
for each record. Therefore, 0.5 hour x 36,084 = 18,042 (18,041.88) one-
time hours for Sec.  1.912(a), as shown in line 3.
    The total one-time hourly third-party disclosure burden is 25,947 
(25,946.57) hours.
    The annual cost of disclosing necessary sanitary specifications, as 
required by Sec.  1.908(b)(1), is estimated at the firm level. It is 
estimated that 1 recordkeeper for each of about 226 firms will spend 5 
minutes disclosing sanitary specifications. Therefore, 0.08 hour x 226 
shipments = 18 (18.07) annual hours for Sec.  1.908(b)(1), as shown in 
line 4.
    The annual cost of disclosing operating temperature conditions, as 
required by Sec.  1.908(b)(2), is estimated at the shipper level. It is 
estimated that 1 recordkeeper for each of about 226 firms will spend 30 
minutes (0.5 hour) disclosing necessary temperature conditions. 
Therefore, 0.5 hour x 226 firms = 113 (112.93) annual hours for Sec.  
1.908(b)(2), as shown in line 5.
    The total annual hourly third-party disclosure burden is 131 
(130.99) hours.

[[Page 20164]]



                                     Table 14--Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
                                                    First year
         21 CFR section              Number of     frequency of    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
----------------------------------------------------------------------------------------------------------------
                             Estimated First Year Only Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
1. Written Sanitary                       10,163               1          10,163             0.5           5,082
 Specifications (1.908(b)(1))...                                                                      (5,081.57)
2. Notification of operating               5,646               1           5,646             0.5           2,823
 temperature (1.908(b)(2))......                                                                      (2,823.13)
3. Records pertaining to                  36,084               1          36,084             0.5          18,042
 disclosure of information                                                                           (18,041.88)
 (1.912(a)).....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          25,947
                                                                                                     (25,946.57)
----------------------------------------------------------------------------------------------------------------
                                 Estimated Annual Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
4. Sanitary Specifications                   226               1             226            0.08              18
 (1.908(b)(1))..................                                                                         (18.07)
5. Operating temperature                     226               1             226             0.5             113
 conditions (1.908(b))(2).......                                                                        (112.93)
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             131
                                                                                                        (130.99)

    The information collection provisions of this final rule have been 
submitted to OMB for review. Prior to the effective date of this final 
rule, FDA will publish a notice in the Federal Register announcing 
OMB's decision to approve, modify, or disapprove the information 
collection provisions in this final rule. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

IX. What is the environmental impact of this rule?

    We have determined, under 21 CFR 25.30(j), that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment (Refs. 32 and 33). Therefore, neither 
an environmental assessment nor an environmental impact statement is 
required.

X. What are the federalism impacts of this rule?

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132 on federalism. We have examined the 
effects of the requirements of this rule on the relationship between 
the Federal Government and the States. We conclude that Federal 
preemption of State or local rules that establish requirements for the 
sanitary transportation of human and animal food such that: (1) 
Complying with the requirements of the State or political subdivision 
and with a requirement of section 416 of the FD&C Act, or with this 
rule, is not possible; or (2) the requirements of the State or 
political subdivision, as applied or enforced, is an obstacle to 
accomplishing and carrying out section 416 of the FD&C Act or this 
rule, is consistent with this Executive order. FDA has not incorporated 
text in this rule to reflect this preemptive effect because section 
416(e) of the FD&C Act expressly provides for this preemption.
    Section 3(b) of Executive Order 13132 recognizes that Federal 
action limiting the policymaking discretion of States is appropriate 
``where there is constitutional and statutory authority for the action 
and the national activity is appropriate in light of the presence of a 
problem of national significance.'' The constitutional basis for FDA's 
authority to regulate food safety is well established. Section 4(a) of 
Executive Order 13132 expressly contemplates preemption where the 
exercise of State authority conflicts with the exercise of Federal 
authority under a Federal statute. Moreover, section 4(b) of Executive 
Order 13132 authorizes preemption of State law by rulemaking when the 
exercise of State authority directly conflicts with the exercise of 
Federal authority under the Federal statute, or there is clear evidence 
to conclude that Congress intended the Agency to have the authority to 
preempt State law.
    Section 4(e) of the Executive order provides that, ``when an agency 
proposes to act through adjudication or rulemaking to preempt State 
law, the agency shall provide all affected State and local officials 
notice and an opportunity for appropriate participation in the 
proceedings.'' As required by the Executive order, FDA provided the 
States and local governments with an opportunity for appropriate 
participation in this rulemaking when it sought input from all 
stakeholders through publication of the proposed rule in the Federal 
Register on February 5, 2014 (79 FR 7006). In the proposal, FDA 
specifically described this preemptive effect. In addition, we held 
three public meetings during the comment period for the proposed rule 
to discuss the provisions of the rule, answer questions, and solicit 
comments from stakeholders, including from State and local government 
representatives. Meetings were held February 27, 2014, in Chicago, IL; 
March 13, 2014, in Anaheim, CA; and March 20, 2014, in College Park, 
MD.
    We received comments on the proposed rule from several State 
government agencies. Most of these comments addressed matters in this 
rulemaking other than the issue of preemption of State and local 
requirements for the sanitary transportation of human and animal food. 
One comment stated that the preemptive provision of section 416(e)(1) 
or (2) of the FD&C Act could function to prevent States from developing 
a unified sanitary transportation regulation that would address all 
modes of transportation. However, a State law, including unified State 
laws, should states wish to adopt such laws, concerning the sanitary 
transportation of food by motor vehicle

[[Page 20165]]

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 conclusion, we have 
determined that the preemptive effects of this final rule are 
consistent with Executive Order 13132.

XI. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at https://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

1. Oxford Dictionary (2015). ``Definition of ``Best Practice,'' 
(https://www.oxforddictionaries.com/us/definition/american_english/best-practice), accessed and printed on December 16, 2015.
2. FDA Memorandum, ``FDA Memorandum to Dockets on Records of 
Outreach,'' 2013. Available in Docket No. FDA-2011-N-0920.
3. FDA Memorandum, ``Memoranda of Outreach,'' 2015.
4. Hennessy. T.W., C.W. Hedberg, L. Slutsker, et al., ``A National 
Outbreak of Salmonella Enteritidis Infections From Ice Cream,'' New 
England Journal of Medicine, 334;1281-1286, 1996; available at 
https://www.nejm.org/doi/full/10.1056/NEJM199605163342001, accessed 
and printed on December 16, 2015.
5. FDA Memorandum, ``Feed RFRs Related to Transportation Problems,'' 
2012.
6. Wojtala, G., Interstate Food Transportation Assessment Project, 
presented at the June 16 through 20, 2007, Conference of the 
Association of Food and Drug Officials, available at https://www.michigan.gov/documents/mda/truckproj_224450_7.pdf, accessed and 
printed on December 16, 2015.
7. Michigan Department of Agriculture, ``Food Truck Assessment 
Project, April 18/19, 2006.''
8. Barfblog, ``200 Pounds of Contaminated Food Headed to Central 
Indiana Restaurants in Semi Destroyed,'' (https://barfblog.com/2013/03/200-pounds-of-contaminated-food-headed-to-central-indiana-restaurants-in-semi-destroyed/), accessed and printed on December 
16, 2015.
9. Caledonia Record, ``DMV Stops Truck, Finds Spoiled Food,'' August 
18, 2012.
10. Courier Journal, ``Overheated Transport Trucks Spark Concerns 
About Spoilage,'' August 10, 2012.
11. Motor Carrier Division, Michigan State Police, ``Commercial 
Motor Vehicle Enforcement Quarterly,'' (https://www.michigan.gov/documents/msp/CMV_Quarterly_January_2007_205099_7.pdf), accessed and 
printed on December, 16, 2015.
12. Eastern Research Group, Inc., 2009, Characteristics of Current 
Food Transportation and Holding Practices for Food Commodities.
13. Tulsa World, ``Food Carriers Doubling as Garbage Trucks,'' June 
11, 1989.
14. Philly.com, ``Food Trucks Can't Haul Waste in PA,'' March 14, 
1990.
15. Los Angeles Times, ``Column One: Some Food Trucks Put Out Trash: 
The same trucks that carry edibles to cities in the Northeast often 
carry waste on the trip back, posing what regulators say is a 
serious risk to health,'' October 20, 1989.
16. FDA, ``Guidance for Industry: Sanitary Transportation of Food,'' 
(https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/sanitationtransportation/ucm208199.htm), accessed and printed on December 16, 2015.
17. FDA, ``Guidance for Industry: Dairy Farms, Bulk Milk 
Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors: 
Food Security Preventive Measures Guidance,'' (https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm083049.htm), accessed and printed on December 17, 
2015.
18. FDA, ``Guidance for Industry: Food Producers, Processors, and 
Transporters: Food Security Preventive Measures Guide,'' (https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm083075.htm), 
accessed and printed on December 17, 2015.
19. Memorandum of Understanding Between The Food Safety and 
Inspection Service, United States Department of Agriculture, and The 
Food and Drug Administration, United States Department of Health and 
Human Services,'' (https://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm117094.htm), accessed and printed on December 16, 
2015.
20. ``Guidance for Industry: Questions and Answers Regarding 
Establishment and Maintenance of Records By Persons Who Manufacture, 
Process, Pack, Transport, Distribute, Receive, Hold, or Import Food 
(Edition 5),'' (https://www.fda.gov/Food/GuidanceRegulation/ucm292746.htm), accessed and printed on December 16, 2015.
21. Consent Decree, Center for Food Safety v. Hamburg, No. 12-cv-
04529-PJH (N.D. Cal. February 20, 2014), (https://www.centerforfoodsafety.org/files/2014-2-20-dkt-82-1-joint-consent-decree_26503.pdf), accessed and printed on December 16, 2015.
22. United States. Office of Management and Budget. Office of 
Information and Regulatory Affairs. ``Memorandum for the Heads of 
Executive Departments and Agencies: Retrospective Analysis of 
Existing Significant Regulations,'' 2011.
23. United States. Office of Management and Budget. Office of 
Information and Regulatory Affairs. ``2013 Report to Congress on the 
Benefits and Costs of Federal Regulations and Unfunded Mandates on 
State, Local, and Tribal Entities,'' 2013.
24. FDA ``Sanitary Transportation of Human and Animal Food, Final 
Regulatory Impact Analysis Final Regulatory Flexibility Analysis 
Unfunded Mandates Reform Act Analysis,'' 2016.
25. S. Rep. No. 109-120, at 46 (2005) (https://www.gpo.gov/fdsys/pkg/CRPT-109srpt120/html/CRPT-109srpt120.htm), accessed and printed 
on December 16, 2015.
26. ``National Shellfish Sanitation Program Guide for the Control of 
Molluscan Shellfish, (2013 Revision),'' (https://www.fda.gov/downloads/Food/GuidanceRegulation/FederalStateFoodPrograms/UCM415522.pdf), accessed and printed on December 16, 2015.
27. ``Produce Transportation Best Practices, North American Produce 
Transportation Working Group,'' (https://www.hortcouncil.ca/uploads/file/naptwg_produce_trans_best_practices.pdf), accessed and printed 
on December 16, 2015.
28. FDA, ``Food Code 2009: Chapter 3--Food,'' 2013.
29. FDA Food Safety Modernization Act, February 27, 2014, (https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM392282.pdf), 
accessed and printed on December 16, 2015.
30. FDA Food Safety Modernization Act (FSMA) Public Meeting, March 
20, 2014, (https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM395355.pdf), accessed and printed on December 16, 2015.
31. FDA, Tribal Impact Summary Statement, 2016.
32. FDA Memorandum, ``Sanitary Transportation of Human and Animal 
Food Regulation,'' 2011.
33. FDA Memorandum, ``Sanitary Transportation of Human and Animal 
Food Final Rule,'' 2015.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 11

    Administrative practice and procedure, Computer technology, 
Reporting and recordkeeping requirements.


[[Page 20166]]


    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
1 and 11 are amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 is revised to read as 
follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342i, 343, 
350c, 350d, 350e, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 
371, 373, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 
243, 262, 264.


0
2. Add subpart O, consisting of Sec. Sec.  1.900 through 1.934, to part 
1 to read as follows:
Subpart O--Sanitary Transportation of Human and Animal Food

General Provisions

Sec.
1.900 Who is subject to this subpart?
1.902 How do the criteria and definitions in this subpart apply 
under the Federal Food, Drug, and Cosmetic Act?
1.904 What definitions apply to this subpart?

Vehicles and Transportation Equipment

1.906 What requirements apply to vehicles and transportation 
equipment?

Transportation Operations

1.908 What requirements apply to transportation operations?

Training

1.910 What training requirements apply to carriers engaged in 
transportation operations?

Records

1.912 What record retention and other records requirements apply to 
shippers, receivers, loaders, and carriers engaged in transportation 
operations?

Waivers

1.914 Under what circumstances will we waive a requirement of this 
subpart?
1.916 When will we consider whether to waive a requirement of this 
subpart?
1.918 What must be included in the Statement of Grounds in a 
petition requesting a waiver?
1.920 What information submitted in a petition requesting a waiver 
or submitted in comments on such a petition is publicly available?
1.922 Who will respond to a petition requesting a waiver?
1.924 What process applies to a petition requesting a waiver?
1.926 Under what circumstances may we deny a petition requesting a 
waiver?
1.928 What process will we follow when waiving a requirement of this 
subpart on our own initiative?
1.930 When will a waiver that we grant become effective?
1.932 Under what circumstances may we modify or revoke a waiver?
1.934 What procedures apply if we determine that a waiver should be 
modified or revoked?

Subpart O--Sanitary Transportation of Human and Animal Food

General Provisions


Sec.  1.900  Who is subject to this subpart?

    (a) Except for non-covered businesses as defined in Sec.  1.904 and 
as provided for in paragraph (b) of this section, the requirements of 
this subpart apply to shippers, receivers, loaders, and carriers 
engaged in transportation operations whether or not the food is being 
offered for or enters interstate commerce. The requirements of this 
subpart apply in addition to any other requirements of this chapter 
that are applicable to the transportation of food, e.g., in 21 CFR 
parts 1, 117, 118, 225, 507, and 589.
    (b) The requirements of this subpart do not apply to shippers, 
receivers, loaders, or carriers when they are engaged in transportation 
operations:
    (1) Of food that is transshipped through the United States to 
another country; or
    (2) Of food that is imported for future export, in accordance with 
section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act, and that 
is neither consumed nor distributed in the United States; or
    (3) Of food when it is located in food facilities as defined in 
Sec.  1.227 of this chapter, that are regulated exclusively, throughout 
the entire facility, by the U.S. Department of Agriculture under the 
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry 
Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products 
Inspection Act (21 U.S.C. 1031 et seq.).


Sec.  1.902  How do the criteria and definitions in this subpart apply 
under the Federal Food, Drug, and Cosmetic Act?

    (a) The criteria and definitions of this subpart apply in 
determining whether food is adulterated within the meaning of section 
402(i) of the Federal Food, Drug, and Cosmetic Act in that the food has 
been transported or offered for transport by a shipper, carrier by 
motor vehicle or rail vehicle, loader, or receiver engaged in 
transportation operations under conditions that are not in compliance 
with this subpart.
    (b) The failure by a shipper, carrier by motor vehicle or rail 
vehicle, loader, or receiver engaged in transportation operations to 
comply with the requirements of this subpart is a prohibited act under 
section 301(hh) of the Federal Food, Drug, and Cosmetic Act.


Sec.  1.904  What definitions apply to this subpart?

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act are applicable to such terms when 
used in this part. The following definitions also apply:
    Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public health practice.
    Animal food means food for animals other than man, and includes pet 
food, animal feed, and raw materials and ingredients.
    Bulk vehicle means a tank truck, hopper truck, rail tank car, 
hopper car, cargo tank, portable tank, freight container, or hopper 
bin, or any other vehicle in which food is shipped in bulk, with the 
food coming into direct contact with the vehicle.
    Carrier means a person who physically moves food by rail or motor 
vehicle in commerce within the United States. The term carrier does not 
include any person who transports food while operating as a parcel 
delivery service.
    Cross-contact means the unintentional incorporation of a food 
allergen as defined in section 201(qq) of the Federal Food, Drug, and 
Cosmetic Act into food, except animal food.
    Farm has the meaning given in Sec.  1.227 of this chapter.
    Food not completely enclosed by a container means any food that is 
placed into a container in such a manner that it is partially open to 
the surrounding environment. Examples of such containers include an 
open wooden basket or crate, an open cardboard box, a vented cardboard 
box with a top, or a vented plastic bag. This term does not include 
food transported in a bulk vehicle as defined in this subpart.
    Full-time equivalent employee is a term used to represent the 
number of employees of a business entity for the purpose of determining 
whether the business is a small business. The number of full-time 
equivalent employees is determined by dividing the total number of 
hours of salary or wages paid directly to employees of the business 
entity and of all of its affiliates and subsidiaries by the number of 
hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 weeks). If 
the result is not a whole number, round down to the next lowest whole 
number.
    Loader means a person that loads food onto a motor or rail vehicle 
during transportation operations.
    Non-covered business means a shipper, loader, receiver, or carrier 
engaged in transportation operations that has less than $500,000, as 
adjusted

[[Page 20167]]

for inflation, in average annual revenues, calculated on a rolling 
basis, during the 3-year period preceding the applicable calendar year. 
For the purpose of determining an entity's 3-year average revenue 
threshold as adjusted for inflation, the baseline year for calculating 
the adjustment for inflation is 2011.
    Operating temperature means a temperature sufficient to ensure that 
under foreseeable circumstances of temperature variation during 
transport, e.g., seasonal conditions, refrigeration unit defrosting, 
multiple vehicle loading and unloading stops, the operation will meet 
the requirements of Sec.  1.908(a)(3).
    Pest means any objectionable animals or insects including birds, 
rodents, flies, and larvae.
    Receiver means any person who receives food at a point in the 
United States after transportation, whether or not that person 
represents the final point of receipt for the food.
    Shipper means a person, e.g., the manufacturer or a freight broker, 
who arranges for the transportation of food in the United States by a 
carrier or multiple carriers sequentially.
    Small business means a business employing fewer than 500 full-time 
equivalent employees except that for carriers by motor vehicle that are 
not also shippers and/or receivers, this term would mean a business 
subject to Sec.  1.900(a) having less than $27,500,000 in annual 
receipts.
    Transportation means any movement of food in by motor vehicle or 
rail vehicle in commerce within the United States.
    Transportation equipment means equipment used in food 
transportation operations, e.g., bulk and non-bulk containers, bins, 
totes, pallets, pumps, fittings, hoses, gaskets, loading systems, and 
unloading systems. Transportation equipment also includes a railcar not 
attached to a locomotive or a trailer not attached to a tractor.
    Transportation operations means all activities associated with food 
transportation that may affect the sanitary condition of food including 
cleaning, inspection, maintenance, loading and unloading, and operation 
of vehicles and transportation equipment. Transportation operations do 
not include any activities associated with the transportation of food 
that is completely enclosed by a container except a food that requires 
temperature control for safety, compressed food gases, food contact 
substances as defined in section 409(h)(6) of the Federal Food, Drug, 
and Cosmetic Act, human food byproducts transported for use as animal 
food without further processing, or live food animals except molluscan 
shellfish. In addition, transportation operations do not include any 
transportation activities that are performed by a farm.
    Vehicle means a land conveyance that is motorized, e.g., a motor 
vehicle, or that moves on rails, e.g., a railcar, which is used in 
transportation operations.

Vehicles and Transportation Equipment


Sec.  1.906  What requirements apply to vehicles and transportation 
equipment?

    (a) Vehicles and transportation equipment used in transportation 
operations must be so designed and of such material and workmanship as 
to be suitable and adequately cleanable for their intended use to 
prevent the food they transport from becoming unsafe, i.e., adulterated 
within the meaning of section 402(a)(1), (2), and (4) of the Federal 
Food, Drug, and Cosmetic Act during transportation operations.
    (b) Vehicles and transportation equipment must be maintained in 
such a sanitary condition for their intended use as to prevent the food 
they transport from becoming unsafe during transportation operations.
    (c) Vehicles and transportation equipment used in transportation 
operations for food requiring temperature control for safety must be 
designed, maintained, and equipped as necessary to provide adequate 
temperature control to prevent the food from becoming unsafe during 
transportation operations.
    (d) Vehicles and transportation equipment must be stored in a 
manner that prevents it from harboring pests or becoming contaminated 
in any other manner that could result in food for which it will be used 
becoming unsafe during transportation operations.

Transportation Operations


Sec.  1.908  What requirements apply to transportation operations?

    (a) General requirements. (1) Unless stated otherwise in this 
section, the requirements of this section apply to all shippers, 
carriers, loaders, and receivers engaged in transportation operations. 
A person may be subject to these requirements in multiple capacities, 
e.g., the shipper may also be the loader and the carrier, if the person 
also performs the functions of those respective persons as defined in 
this subpart. An entity subject to this subpart (shipper, loader, 
carrier, or receiver) may reassign, in a written agreement, its 
responsibilities under this subpart to another party subject to this 
subpart. The written agreement is subject to the records requirements 
of Sec.  1.912(d).
    (2) Responsibility for ensuring that transportation operations are 
carried out in compliance with all requirements in this subpart must be 
assigned to competent supervisory personnel.
    (3) All transportation operations must be conducted under such 
conditions and controls necessary to prevent the food from becoming 
unsafe during transportation operations including:
    (i) Taking effective measures such as segregation, isolation, or 
the use of packaging to protect food from contamination by raw foods 
and nonfood items in the same load.
    (ii) Taking effective measures such as segregation, isolation, or 
other protective measures, such as hand washing, to protect food 
transported in bulk vehicles or food not completely enclosed by a 
container from contamination and cross-contact during transportation 
operations.
    (iii) Taking effective measures to ensure that food that requires 
temperature control for safety is transported under adequate 
temperature control.
    (4) The type of food, e.g., animal feed, pet food, human food, and 
its production stage, e.g., raw material, ingredient or finished food, 
must be considered in determining the necessary conditions and controls 
for the transportation operation.
    (5) Shippers, receivers, loaders, and carriers, which are under the 
ownership or operational control of a single legal entity, as an 
alternative to meeting the requirements of paragraphs (b), (d), and (e) 
of this section may conduct transportation operations in conformance 
with common, integrated written procedures that ensure the sanitary 
transportation of food consistent with the requirements of this 
section. The written procedures are subject to the records requirements 
of Sec.  1.912(e).
    (6) If a shipper, loader, receiver, or carrier 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 food shall not be sold or otherwise distributed, and these persons 
must take appropriate action including, as necessary, communication 
with other parties 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.
    (b) Requirements applicable to shippers engaged in transportation

[[Page 20168]]

operations. (1) Unless the shipper takes other measures in accordance 
with paragraph (b)(3) of this section to ensure that vehicles and 
equipment used in its transportation operations are in appropriate 
sanitary condition for the transportation of the food, i.e., that will 
prevent the food from becoming unsafe, the shipper must specify to the 
carrier and, when necessary, the loader, in writing, all necessary 
sanitary specifications for the carrier's vehicle and transportation 
equipment to achieve this purpose, including any specific design 
specifications and cleaning procedures. One-time notification shall be 
sufficient unless the design requirements and cleaning procedures 
required for sanitary transport change based upon the type of food 
being transported, in which case the shipper shall so notify the 
carrier in writing before the shipment. The information submitted by 
the shipper to the carrier is subject to the records requirements in 
Sec.  1.912(a).
    (2) Unless the shipper takes other measures in accordance with 
paragraph (b)(5) of this section to ensure that adequate temperature 
control is provided during the transportation of food that requires 
temperature control for safety under the conditions of shipment, a 
shipper of such food must specify in writing to the carrier, except a 
carrier who transports the food in a thermally insulated tank, and, 
when necessary, the loader, an operating temperature for the 
transportation operation including, if necessary, the pre-cooling 
phase. One-time notification shall be sufficient unless a factor, e.g., 
the conditions of shipment, changes, necessitating a change in the 
operating temperature, in which case the shipper shall so notify the 
carrier in writing before the shipment. The information submitted by 
the shipper to the carrier is subject to the records requirements in 
Sec.  1.912(a).
    (3) A shipper must develop and implement written procedures, 
subject to the records requirements of Sec.  1.912(a), adequate to 
ensure that vehicles and equipment used in its transportation 
operations are in appropriate sanitary condition for the transportation 
of the food, i.e., will prevent the food from becoming unsafe during 
the transportation operation. Measures to implement these procedures 
may be accomplished by the shipper or by the carrier or another party 
covered by this subpart under a written agreement subject to the 
records requirements of Sec.  1.912(a).
    (4) A shipper of food transported in bulk must develop and 
implement written procedures, subject to the records requirements of 
Sec.  1.912(a), adequate to ensure that a previous cargo does not make 
the food unsafe. Measures to ensure the safety of the food may be 
accomplished by the shipper or by the carrier or another party covered 
by this subpart under a written agreement subject to the records 
requirements of Sec.  1.912(a).
    (5) The shipper of food that requires temperature control for 
safety under the conditions of shipment must develop and implement 
written procedures, subject to the records requirements of Sec.  
1.912(a), to ensure that the food is transported under adequate 
temperature control. Measures to ensure the safety of the food may be 
accomplished by the shipper or by the carrier or another party covered 
by this subpart under a written agreement subject to the records 
requirements of Sec.  1.912(a) and must include measures equivalent to 
those specified for carriers under paragraphs (e)(1) through (3) of 
this section.
    (c) Requirements applicable to loaders engaged in transportation 
operations. (1) Before loading food not completely enclosed by a 
container onto a vehicle or into transportation equipment the loader 
must determine, considering, as appropriate, specifications provided by 
the shipper in accordance with paragraph (b)(1) of this section, that 
the vehicle or transportation equipment is in appropriate sanitary 
condition for the transport of the food, e.g., it is in adequate 
physical condition, and free of visible evidence of pest infestation 
and previous cargo that could cause the food to become unsafe during 
transportation. This may be accomplished by any appropriate means.
    (2) Before loading food that requires temperature control for 
safety, the loader must verify, considering, as appropriate, 
specifications provided by the shipper in accordance with paragraph 
(b)(2) of this section, that each mechanically refrigerated cold 
storage compartment or container is adequately prepared for the 
transportation of such food, including that it has been properly pre-
cooled, if necessary, and meets other sanitary conditions for food 
transportation.
    (d) Requirements applicable to receivers engaged in transportation 
operations. Upon receipt of food that requires temperature control for 
safety under the conditions of shipment, the receiver must take steps 
to adequately assess that the food was not subjected to significant 
temperature abuse, such as determining the food's temperature, the 
ambient temperature of the vehicle and its temperature setting, and 
conducting a sensory inspection, e.g., for off-odors.
    (e) Requirements applicable to carriers engaged in transportation 
operations. When the carrier and shipper have a written agreement that 
the carrier is responsible, in whole or in part, for sanitary 
conditions during the transportation operation, the carrier is 
responsible for the following functions as applicable per the 
agreement:
    (1) A carrier must ensure that vehicles and transportation 
equipment meet the shipper's specifications and are otherwise 
appropriate to prevent the food from becoming unsafe during the 
transportation operation.
    (2) A carrier must, once the transportation operation is complete 
and if requested by the receiver, provide the operating temperature 
specified by the shipper in accordance with paragraph (b)(2) of this 
section and, if requested by the shipper or receiver, demonstrate that 
it has maintained temperature conditions during the transportation 
operation consistent with the operating temperature specified by the 
shipper in accordance with paragraph (b)(2) of this section. Such 
demonstration may be accomplished by any appropriate means agreeable to 
the carrier and shipper, such as the carrier presenting measurements of 
the ambient temperature upon loading and unloading or time/temperature 
data taken during the shipment.
    (3) Before offering a vehicle or transportation equipment with an 
auxiliary refrigeration unit for use for the transportation of food 
that requires temperature control for safety under the conditions of 
the shipment during transportation, a carrier must pre-cool each 
mechanically refrigerated cold storage compartment as specified by the 
shipper in accordance with paragraph (b)(2) of this section.
    (4) If requested by the shipper, a carrier that offers a bulk 
vehicle for food transportation must provide information to the shipper 
that identifies the previous cargo transported in the vehicle.
    (5) If requested by the shipper, a carrier that offers a bulk 
vehicle for food transportation must provide information to the shipper 
that describes the most recent cleaning of the bulk vehicle.
    (6) A carrier must develop and implement written procedures subject 
to the records requirements of Sec.  1.912(b) that:
    (i) Specify practices for cleaning, sanitizing if necessary, and 
inspecting vehicles and transportation equipment that the carrier 
provides for use in the transportation of food to maintain the vehicles 
and the transportation equipment in appropriate sanitary condition as 
required by Sec.  1.906(b);

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    (ii) Describe how it will comply with the provisions for 
temperature control in paragraph (e)(2) of this section, and;
    (iii) Describe how it will comply with the provisions for the use 
of bulk vehicles in paragraphs (e)(4) and (5) of this section.

 Training


Sec.  1.910  What training requirements apply to carriers engaged in 
transportation operations?

    (a) When the carrier and shipper have agreed in a written contract 
that the carrier is responsible, in whole or in part, for the sanitary 
conditions during transportation operations, the carrier must provide 
adequate training to personnel engaged in transportation operations 
that provides an awareness of potential food safety problems that may 
occur during food transportation, basic sanitary transportation 
practices to address those potential problems, and the responsibilities 
of the carrier under this part. The training must be provided upon 
hiring and as needed thereafter.
    (b) Carriers must establish and maintain records documenting the 
training described in paragraph (a) of this section. Such records must 
include the date of the training, the type of training, and the 
person(s) trained. These records are subject to the records 
requirements of Sec.  1.912(c).

Records


Sec.  1.912  What record retention and other records requirements apply 
to shippers, receivers, loaders, and carriers engaged in transportation 
operations?

    (a) Shippers must retain records:
    (1) That demonstrate that they provide specifications and operating 
temperatures to carriers as required by Sec.  1.908(b)(1) and (2) as a 
regular part of their transportation operations for a period of 12 
months beyond the termination of the agreements with the carriers.
    (2) Of written agreements and the written procedures required by 
Sec.  1.908(b)(3), (4), and (5), for a period of 12 months beyond when 
the agreements and procedures are in use in their transportation 
operations.
    (b) Carriers must retain records of the written procedures required 
by Sec.  1.908(e)(6) for a period of 12 months beyond when the 
agreements and procedures are in use in their transportation 
operations.
    (c) Carriers must retain training records required by Sec.  
1.910(b) for a period of 12 months beyond when the person identified in 
any such records stops performing the duties for which the training was 
provided.
    (d) Any person subject to this subpart must retain any other 
written agreements assigning tasks in compliance with this subpart for 
a period of 12 months beyond the termination of the agreements.
    (e) Shippers, receivers, loaders, and carriers, which operate under 
the ownership or control of a single legal entity in accordance with 
the provisions of Sec.  1.908(a)(5), must retain records of the written 
procedures for a period of 12 months beyond when the procedures are in 
use in their transportation operations.
    (f) Shippers, receivers, loaders, and carriers must make all 
records required by this subpart available to a duly authorized 
individual promptly upon oral or written request.
    (g) All records required by this subpart must be kept as original 
records, true copies (such as photocopies, pictures, scanned copies, 
microfilm, microfiche, or other accurate reproductions of the original 
records), or electronic records.
    (h) Records that are established or maintained to satisfy the 
requirements of this subpart and that meet the definition of electronic 
records in Sec.  11.3(b)(6) of this chapter are exempt from the 
requirements of part 11 of this chapter. Records that satisfy the 
requirements of this subpart, but that also are required under other 
applicable statutory provisions or regulations, remain subject to part 
11 of this chapter.
    (i) Except for the written procedures required by Sec.  
1.908(e)(6)(i), offsite storage of records is permitted if such records 
can be retrieved and provided onsite within 24 hours of request for 
official review. The written procedures required by Sec.  
1.908(e)(6)(i) must remain onsite as long as the procedures are in use 
in transportation operations. Electronic records are considered to be 
onsite if they are accessible from an onsite location.
    (j) All records required by this subpart are subject to the 
disclosure requirements under part 20 of this chapter.

Waivers


Sec.  1.914  Under what circumstances will we waive a requirement of 
this subpart?

    We will waive any requirement of this subpart with respect to any 
class of persons, vehicles, food, or nonfood products, when we 
determine that:
    (a) The waiver will not result in the transportation of food under 
conditions that would be unsafe for human or animal health; and
    (b) The waiver will not be contrary to the public interest.


Sec.  1.916  When will we consider whether to waive a requirement of 
this subpart?

    We will consider whether to waive a requirement of this subpart on 
our own initiative or on the petition submitted under Sec.  10.30 of 
this chapter by any person who is subject to the requirements of this 
subpart with respect to any class of persons, vehicles, food, or 
nonfood products.


Sec.  1.918  What must be included in the Statement of Grounds in a 
petition requesting a waiver?

    In addition to the requirements set forth in Sec.  10.30 of this 
chapter, the Statement of Grounds in a petition requesting a waiver 
must:
    (a) Describe with particularity the waiver requested, including the 
persons, vehicles, food, or nonfood product(s) to which the waiver 
would apply and the requirement(s) of this subpart to which the waiver 
would apply; and
    (b) Present information demonstrating that the waiver will not 
result in the transportation of food under conditions that would be 
unsafe for human or animal health and will not be contrary to the 
public interest.


Sec.  1.920  What information submitted in a petition requesting a 
waiver or submitted in comments on such a petition is publicly 
available?

    We will presume that information submitted in a petition requesting 
a waiver and comments submitted on such a petition does not contain 
information exempt from public disclosure under part 20 of this chapter 
and would be made public as part of the docket associated with this 
request.


Sec.  1.922  Who will respond to a petition requesting a waiver?

    The Director or Deputy Directors of the Center for Food Safety and 
Applied Nutrition (CFSAN) or the Center for Veterinary Medicine (CVM), 
or the Director, Office of Compliance, CFSAN, or the Director, Office 
of Surveillance and Compliance, CVM, will respond to a petition 
requesting a waiver.


Sec.  1.924  What process applies to a petition requesting a waiver?

    (a) In general, the procedures set forth in Sec.  10.30 of this 
chapter govern our response to a petition requesting a waiver.
    (b) Under Sec.  10.30(h)(3) of this chapter, we will publish a 
notice in the Federal Register, requesting information and views on a 
filed petition, including information and views from persons who could 
be affected by the waiver if the petition were to be granted.
    (c) Under Sec.  10.30(e)(3) of this chapter, we will respond to the 
petitioner in writing.

[[Page 20170]]

    (1) If we grant the petition, either in whole or in part, we will 
publish a notice in the Federal Register setting forth any waiver and 
the reasons for such waiver.
    (2) If we deny the petition (including partial denials), our 
written response to the petitioner will explain the reason(s) for the 
denial.
    (d) We will make readily accessible to the public, and periodically 
update, a list of filed petitions requesting waivers, including the 
status of each petition (for example, pending, granted, or denied).


Sec.  1.926  Under what circumstances may we deny a petition requesting 
a waiver?

    We may deny a petition requesting a waiver if the petition does not 
provide the information required under Sec.  1.918 (including the 
requirements of Sec.  10.30 of this chapter), or if we determine that 
the waiver could result in the transportation of food under conditions 
that would be unsafe for human or animal health, or that the waiver 
could be contrary to the public interest.


Sec.  1.928  What process will we follow when waiving a requirement of 
this subpart on our own initiative?

    If we, on our own initiative, determine that a waiver is 
appropriate, we will publish a notice in the Federal Register setting 
forth the waiver and the reasons for such waiver.


Sec.  1.930  When will a waiver that we grant become effective?

    Any waiver that we grant will become effective on the date that 
notice of the waiver is published in the Federal Register.


Sec.  1.932  Under what circumstances may we modify or revoke a waiver?

    We may modify or revoke a waiver if we determine that the waiver 
could result in the transportation of food under conditions that would 
be unsafe for human or animal health or that the waiver could be 
contrary to the public interest.


Sec.  1.934  What procedures apply if we determine that a waiver should 
be modified or revoked?

    (a) We will provide the following notifications:
    (1) We will notify the entity that initially requested the waiver, 
in writing at the address identified in its petition, if we determine 
that a waiver granted in response to its petition should be modified or 
revoked.
    (2) We will publish a notice of our determination that a waiver 
should be modified or revoked in the Federal Register. This notice will 
establish a public docket so that interested parties may submit written 
submissions on our determination.
    (b) We will consider timely written submissions submitted to the 
public docket from interested parties.
    (c) We will publish a notice of our decision in the Federal 
Register. The effective date of the decision will be the date of 
publication of the notice.

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
3. The authority citation for 21 CFR part 11 continues to read as 
follows:

    Authority:  21 U.S.C. 321-393; 42 U.S.C. 262.


0
4. Section 11.1 is amended by adding paragraph (n) to read as follows:


Sec.  11.1  Scope.

* * * * *
    (n) This part does not apply to records required to be established 
or maintained by subpart O of part 1 of this chapter. Records that 
satisfy the requirements of subpart O of part 1 of this chapter, but 
that also are required under other applicable statutory provisions or 
regulations, remain subject to this part.

    Dated: March 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07330 Filed 4-5-16; 8:45 am]
 BILLING CODE 4164-01-P