Sanitary Transportation of Human and Animal Food, 7005-7037 [2014-02188]

Agencies

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

[Federal Register Volume 79, Number 24 (Wednesday, February 5, 2014)]
[Proposed Rules]
[Pages 7005-7037]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02188]



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Vol. 79

Wednesday,

No. 24

February 5, 2014

Part II





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Part 1





Sanitary Transportation of Human and Animal Food; Proposed Rule

Federal Register / Vol. 79 , No. 24 / Wednesday, February 5, 2014 / 
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

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


Sanitary Transportation of Human and Animal Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to 
establish requirements for shippers, 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 FDA Food Safety 
Modernization Act of 2011 (FSMA).

DATES: Submit either electronic or written comments on the proposed 
rule by May 31, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0013 and/or Regulatory Information Number (RIN) 0910-AG98, by any of 
the following methods except that comments on information collection 
issues under the Paperwork Reduction Act of 1995 must be submitted to 
the Office of Information and Regulatory Affairs, Office of Management 
and Budget (OMB) (see the ``Paperwork Reduction Act of 1995'' section 
of this document):

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency 
name, Docket No. FDA-2013-N-0013, and RIN 0910-AG98 for this 
rulemaking. All comments received may be posted without change to 
https://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this document into 
the ``Search'' box and follow the prompts, and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 
    With regard to this proposed rule: Michael E. Kashtock, Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2022.
    With regard to the information collection: Domini Bean, Office of 
Operations, Food and Drug Administration, 1350 Picard Dr., PI50-400T, 
Rockville, MD 20850, domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Executive Summary

Purpose of the Proposed Rule

    The Food Safety Modernization Act 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. 
Isolated incidents of insanitary transportation practices for human and 
animal food and outbreaks and illnesses caused by contamination of 
these foods during transport there have resulted in concerns over the 
past decades about the potential that food can become contaminated 
during transportation. The goal of the proposed rule is to ensure that 
transportation practices do not create food safety risks. Practices 
that create such risk include failure to properly refrigerate food, 
inadequate cleaning of vehicles between loads, and failure to properly 
protect food during transportation. The proposed rule builds on current 
safe food transport 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. It otherwise 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. The proposed rule would 
not cover shippers, receivers, or carriers engaged in food 
transportation operations that have less than $500,000 in total annual 
sales. In addition, the requirements in the proposed rule would not 
apply to the transportation of fully packaged shelf-stable foods, live 
food animals and raw agricultural commodities (RACs) when RACs are 
transported by farms. In addition, persons subject to the rule could 
request waivers from its requirements if they can show that the waiver 
will not result in the transportation of food under conditions that 
would be unsafe for human and animal health and will not be contrary to 
the public interest.

Summary of the Major Provisions of the Proposed Rule

    As required by FSMA, the proposed rule would address the sanitary 
transportation of food (human and animal food) by establishing criteria 
and definitions that would apply in determining 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 
engaged in the transportation of food under conditions that are not in 
compliance with the sanitary food transportation regulations.
    The proposed rule would define transportation as any movement of 
food in commerce by motor vehicle or rail vehicle. The proposed rule 
would also establish requirements for sanitary transportation practices 
applicable to shippers, carriers by motor vehicle and rail vehicle, and 
receivers engaged in food transportation operations.
    Specifically, the proposed rule would 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

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controls necessary to prevent contamination and other safety hazards.
    The proposed rule is intended to ensure that persons engaged in the 
transportation of food that is at the greatest risk for contamination 
during transportation follow appropriate sanitary transportation 
practices. For example, the proposed rule would require that shippers 
inspect a vehicle for cleanliness prior to loading food that is not 
completely enclosed by its container, e.g., fresh produce in vented 
boxes, onto the vehicle. The proposed rule would also require that 
persons engaged in transportation operations for foods that require 
time/temperature control to ensure their safety (TCS food), e.g., meat, 
poultry, seafood, raw seed sprouts, or unpasteurized shell eggs, or to 
prevent microbial spoilage, e.g., pasteurized juice, take actions to 
ensure the maintenance of the transportation cold chain such as the 
pre-cooling of the vehicle by the carrier with subsequent verification 
by the shipper before the food is loaded onto the vehicle.
    The proposed rule would require that shippers specify to carriers 
in writing the sanitary requirements for a vehicle or transportation 
equipment to be provided for all food subject to this proposal and the 
temperature requirements for foods subject to temperature control 
requirements. The proposed rule would require that shippers maintain 
records that demonstrate that they provide this information to 
carriers.
    Additionally, for food subject to temperature control requirements, 
the proposed rule would require that carriers demonstrate to shippers 
and, upon request, to receivers that they have maintained appropriate 
temperature control for the food during the transportation operation. 
The proposed rule would also require carriers to provide information to 
shippers about previous cargoes hauled in bulk vehicles offered for the 
transportation of food and the intervening cleaning of those vehicles. 
The proposed rule would require that carriers develop and implement 
written procedures subject to recordkeeping that describe how they will 
provide these items of information to shippers and receivers.
    The proposed rule would establish requirements for carriers to 
develop and implement written procedures subject to recordkeeping that 
specify its practices for cleaning, sanitizing, and inspecting vehicles 
and transportation equipment as required by this rule.
    The proposed rule would establish requirements for the training of 
carrier personnel engaged in transportation operations, including a 
requirement for records that document the training.
    Further, the proposed rule would establish procedures by which FDA 
will waive any of these requirements if FDA determines 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, and procedures that FDA will follow when revoking 
such waivers.
    The proposed rule would not cover shippers, receivers, or carriers 
engaged in food transportation operations that have less than $500,000 
in total annual sales.
    We have developed this proposed rule implementing the 2005 SFTA and 
FSMA to operate in conjunction with other rules we will be issuing 
under FSMA to ensure that the safety of food during transportation is 
effectively addressed as part of FDA's comprehensive effort to 
strengthen the food safety system. Under FSMA, FDA has proposed rules 
on Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Human Food (78 FR 3646, January 16, 2013) 
and animal (78 FR 64736, October 29, 2013) food facilities (the 
proposed preventive controls rules for human and animal food, 
respectively) and on Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption (78 FR 3504, January 16, 
2013).

Costs and Benefits

    This proposed rule is estimated to cover 83,609 firms. This number 
includes carriers engaged in food transportation and food facilities 
including the U.S. Department of Agriculture (USDA) establishments that 
ship food subject to this proposed rule. Total first year cost is 
estimated to be $149.1 million (with an average of $1,784 per firm), 
and total annual cost is estimated to be $30.08 million (with an 
average of $360 per firm).
    We lack sufficient data to quantify the potential benefits of the 
proposed rule. The causal chain from inadequate food transportation to 
human and animal health and welfare can be specified but not 
quantified. Because no complete data exist to precisely quantify the 
likelihood of food becoming adulterated during its transport, we are 
unable to estimate the effectiveness of the requirements of the 
proposed rule to reduce potential adverse health effects in humans or 
animals. Furthermore, while we expect small changes in behavior (in the 
form of safer practices), we do not anticipate large scale changes in 
practices as a result of the requirements of this proposed rule. 
Nevertheless, improving food transportation systems could reduce the 
number of recalls, reduce the risk of adverse health effects related to 
such contaminated human and animal food and feed, and reduce the losses 
of contaminated human and animal food and feed ingredients and 
products.

Table of Contents

I. Background
II. Legal Authority
III. Description of the Proposed Rule
    A. Scope (Proposed Sec.  1.900)
    B. Applicability (Proposed Sec.  1.902)
    C. Definitions (Proposed Sec.  1.904)
    D. Vehicles and Transportation Equipment (Proposed Sec.  1.906)
    E. Transportation Operations (Proposed Sec.  1.908)
    F. Training (Proposed Sec.  1.910)
    G. Records (Proposed Sec.  1.912)
    H. Waivers (Proposed Sec. Sec.  1.914--1.934)
IV. Preliminary Regulatory Impact Analysis
    A. Overview
    B. Regulatory Flexibility Act
    C. Unfunded Mandates Reform Act of 1995
V. Paperwork Reduction Act of 1995
VI. Analysis of Environmental Impact
VII. Federalism
VIII. Proposed Effective and Compliance Dates
IX. Request for Comments
X. References

I. Background

    Due to illness outbreaks involving human food and animal food that 
became contaminated during transportation (Ref. 1) (Ref. 2) and 
incidents and reports of insanitary transportation practices (Ref. 3) 
(Ref. 4) (Ref. 5) (Ref. 6) (Ref. 7) (Ref. 8), 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. 9). 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 led to concern that food products could become contaminated 
and unfit for human consumption if irresponsible vehicle operators 
failed to prevent contamination of food products in vehicles that had 
been previously used to haul waste or other non-food materials. 
Congress responded to these concerns by passing the Sanitary Food 
Transportation Act of 1990 (1990 SFTA) 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

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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. 1).
    In 2005 Congress withdrew the 1990 SFTA and passed the 2005 SFTA, a 
broader food transportation safety law than the 1990 SFTA in that its 
focus was not limited only to preventing food contamination from 
nonfood sources during transportation. The 2005 SFTA directed FDA 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.
    In April of 2010 FDA issued guidance to provide the industry with 
broadly applicable recommendations for controls to prevent food safety 
problems during transport while it was in the process of implementing 
2005 SFTA (Ref. 10).
    As part of our implementation of the 2005 SFTA, we also issued an 
advance notice of proposed rulemaking in 2010 (the 2010 ANPRM; 75 FR 
22713) to request data and information on the food transportation 
industry and its practices and on the contamination of transported 
foods and any associated outbreaks.
    In the 2010 ANPRM we discussed the concerns about safe food 
transportation dating from the 1980s as well as current practices in 
the food transportation industry and areas where food is at risk for 
contamination. We discussed DOTs actions in response to the 1990 SFTA. 
We also noted findings released in 2007, of an Interstate Food 
Transportation Project carried out by a number of Midwestern states 
(Refs. 3) (Ref. 4). The purpose of the project was to determine the 
current state of food safety and food defense in the context of in-
transit food in interstate commerce. The project identified several 
areas of concern in food transport relevant to this rulemaking that 
increase the likelihood of food contamination, such as improper 
refrigeration, transport of raw meat and poultry in a manner that could 
result in cross-contamination of fresh fruits and vegetables 
transported in the same vehicle (cross-contamination is the transfer of 
harmful bacteria to food from other foods when food is improperly 
handled), improper packaging, infestation with insects, insanitary 
storage (e.g., roof leaks and moldy walls, animal blood and food on bed 
floors), low driver awareness of safe food temperatures, and inadequate 
food safety training of drivers. Most of the specific instances where 
food transportation problems were found involved smaller box trucks; 
there were ``little or no areas of concern'' identified with larger 
(semi-tractor trailer) trucks inspected during the project's survey.
    We also discussed the findings, issued in a 2009 report, of a study 
conducted for FDA by the Eastern Research Group (the ERG report) to 
characterize current baseline practices in the sectors involved in food 
transportation and to identify current areas where food is at risk for 
adulteration (Ref. 9).
    The ERG report identified a number of areas where food may be at 
risk for physical, chemical, or biological contamination during 
transport and storage:
     Improper refrigeration or temperature control of food 
products (temperature abuse).
     Improper management of transportation units or storage 
facilities to preclude cross-contamination, including improper 
sanitation, backhauling hazardous materials, not maintaining tanker 
wash records, improper disposal of wastewater, and aluminum phosphide 
fumigation methods in railcar transit;
     Improper packing of transportation units or storage 
facilities, including incorrect use of packing materials and poor 
pallet quality;
     Improper loading practices, conditions, or equipment, 
including improper sanitation of loading equipment, not using dedicated 
units where appropriate, inappropriate loading patterns, and 
transporting mixed loads that increase the risk for cross-
contamination;
     Improper unloading practices, conditions, or equipment, 
including improper sanitation of equipment and leaving raw materials on 
loading docks after hours;
     Poor pest control in transportation units or storage 
facilities;
     Lack of driver/employee training and/or supervisor/
manager/owner knowledge of food safety and/or security;
     Poor transportation unit design and construction;
     Inadequate preventive maintenance for transportation units 
or storage facilities, resulting in roof leaks, gaps in doors, and 
dripping condensation or ice accumulations;
     Poor employee hygiene;
     Inadequate policies for the safe and/or secure transport 
or storage of foods;
     Improper handling and tracking of rejected loads and 
salvaged, reworked, and returned products or products destined for 
disposal; and
     Improper holding practices for food products awaiting 
shipment or inspection, including unattended product, delayed holding 
of product, shipping of product while in quarantine, and poor rotation 
and throughput.
    To obtain data that would be current and relevant and to augment 
the information in the ERG report, we requested public comments 
containing data and information on questions associated with several 
specific issues (see the 2010 ANPRM for the issues and questions). We 
received about 45 comments from a variety of submitters including human 
and animal food processors and their trade organizations, food 
distributors and their trade organizations, food retailers and their 
trade organizations, transportation equipment manufacturers and 
suppliers, motor and rail carriers and their trade organizations, an 
organization representing independent truck owner-operators, a State 
government agency, a consumer advocacy organization, and individual 
consumers. Where comments informed specific provisions of this proposed 
rule, we discuss those comments in the relevant part of section III of 
this document.
    A few comments addressed section 416(c)(2)(A) and (c)(2)(B) of the 
2005 SFTA, which direct FDA to include in the sanitary food 
transportation regulations: (1) A list of nonfood products that the 
Secretary of Health and Human Services (the Secretary) determines may, 
if shipped in a bulk vehicle, render adulterated food that is 
subsequently transported in the same vehicle; and (2) a list of nonfood 
products that the Secretary determines 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. Some of the comments addressing this 
subject offered that lists that prohibit the transport of food and non-
food items together would be illogical because they would create 
requirements for commercial food transportation that do not reflect how 
consumers privately transport food, wherein they transport food and 
non-food items together to their homes. One comment asserted that the 
simultaneous transportation of food and hazardous materials should be 
prohibited.
    While certain combinations of non-food cargos and food cargos 
(either as a co-cargo or subsequent cargo) may

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present the potential for adulteration of the food cargo under certain 
conditions of transportation, the likelihood of such adulteration is 
very situation specific. This is because the ability of a non-food 
product to adulterate a food product in either case is dependent upon, 
among other things: The construction of the vehicle; the nature and 
concentration of the non-food product and any contaminants therein 
contained; the manner and extent of cleaning and sanitizing operations 
between the cargos; the nature, subsequent processing, and intended use 
of the food cargo; the manner in which the food and non-food cargos are 
stored in the vehicle (for non-bulk vehicles); and the manner in which 
food and non-food cargos are packaged (for non-bulk vehicles). For this 
reason, we have tentatively concluded that we cannot identify any 
specific non-food product that may, under all circumstances, adulterate 
food subsequently hauled in a bulk vehicle, such that we could propose 
a list of such products in this proposed rule. We have also tentatively 
concluded that we cannot identify any specific non-food products that 
may, under all circumstances, adulterate food subsequently or 
simultaneously hauled in a non-bulk vehicle, such that we could propose 
a list of such products in this proposed rule. However, we have also 
tentatively concluded that guidance on how the specifics of the 
transportation operation affect the potential for non-food products to 
adulterate food products would be helpful to the transportation 
industry and intend to develop such guidance upon publication of this 
final rule. We request comment on these tentative conclusions.
    Further, we recognize that within the bulk and non-bulk segments of 
the food transportation industry, carriers routinely transport non-food 
items in vehicles that subsequently or simultaneously (for non-bulk 
vehicles) haul food. Based upon the comments we received in response to 
the 2010 ANPRM, we believe that in many instances, shippers and 
carriers working together, e.g., through information sharing, establish 
procedures for transportation operations that adequately address any 
concerns that may exist about non-food prior and co-cargos. In other 
instances, transportation operations are carried out in accordance with 
various industry best practices guidelines that address non-food prior 
and co-cargos. This proposed rule, and the proposed preventive controls 
rules for human and animal food, will establish new requirements that 
will, respectively, provide for information disclosure between shippers 
and carriers and consideration of transportation practices within a 
facility's hazard analysis, that we tentatively conclude will be 
sufficient to enable shippers covered by this proposed rule and 
facilities covered by the proposed preventive controls rules to 
establish safe transportation practices for their bulk and non-bulk 
shipments where non-food prior or co-cargos are a consideration.

II. Legal Authority

    We are issuing this proposed rule under the 2005 SFTA and as 
directed by section 111(a) of FSMA.
    The 2005 SFTA amended the Federal Food, Drug, and Cosmetic Act 
(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 directed us to issue 
regulations to require shippers, carriers by motor vehicle or rail 
vehicle, receivers, and other persons engaged in the transportation of 
food 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.
    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, and new section 301(hh) in the 
FD&C Act (21 U.S.C. 331(hh)) to prohibit 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 proposed rule also derives from sections 
402(a)(1), (a)(3), (a)(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)(3) of the FD&C Act provides that a food is adulterated if it 
consists in whole or in part of any filthy, putrid, or decomposed 
substance, or if it is otherwise unfit for food. 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. The proposed rule includes requirements that are necessary to 
prevent food from being adulterated (either by becoming filthy, putrid, 
decomposed or otherwise unfit for food, or being rendered injurious to 
health from any source) during transportation operations. These 
requirements allow for the efficient enforcement of the FD&C Act.

III. Description of the Proposed Rule

    We are proposing to establish new 21 CFR part 1, subpart O, 
entitled ``Sanitary Transportation of Human and Animal Food.'' The 
proposed rule would specify sanitary transportation practices to be 
used by shippers, carriers by motor vehicle and rail vehicle, and 
receivers engaged in the transportation of food to ensure that food is 
not transported under conditions that may render the food adulterated.

A. Scope (Proposed Sec.  1.900)

    Proposed Sec.  1.900 addresses who is subject to the requirements 
of subpart O. Proposed Sec.  1.900(a) would provide that except for 
non-covered businesses as defined in proposed Sec.  1.904 (who would 
not be subject to this rule as discussed

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in section III.C of this document), the requirements of subpart O would 
apply to shippers, receivers, and carriers engaged in transportation 
operations for food whether or not the food is offered for or enters 
interstate commerce. Proposed Sec.  1.900(b) would provide that the 
requirements of subpart O do not apply to shippers, receivers, or 
carriers when they are engaged in transportation operations of: (1) 
Food that is transshipped through the United States to another country; 
or (2) food that is imported for future export and that is neither 
consumed or distributed in the United States.
1. Other Persons Engaged in the Transportation of Food
    Section 416(b) of the FD&C Act explicitly states that these 
regulations should address ``other persons'' engaged in the 
transportation of food. We considered what other entities could 
constitute ``other persons'' engaged in the transportation of food who 
are not shippers, receivers, or carriers and whether proposing 
requirements for ``other persons'' engaged in the transportation of 
food was necessary to ensure that food is not transported under 
conditions that may render the food adulterated. As part of that 
consideration we reviewed the comments to the 2010 ANPRM for any 
information that might suggest that applying the provisions of this 
proposed rule to such persons might substantially further the use of 
sanitary food transportation practices. After reviewing these comments 
and other information available to us about the transportation 
industry, and considering the definitions we are proposing for 
shippers, carriers, and receivers, we have tentatively concluded that 
there are not ``other persons'' engaged in the transportation of food 
whose function in food transportation would be expected to affect the 
sanitary condition of food, and as such, should be subject to the 
requirements of this rule. Therefore we are not proposing to subject 
persons other than shippers, receivers, and carriers to the 
requirements of this proposed rule. We request comment on whether any 
other persons should be subject to this proposed rule under the 
authority provided by section 416(b) of the FD&C Act. The comments 
should identify the specific function of the person in food 
transportation, explain how that person does not meet the definition of 
shipper, carrier, or receiver, describe how that person's actions may 
affect the sanitary condition of food, and describe the kinds of 
regulatory provisions that should be applied to that person.
2. Intrastate Activities
    FDA tentatively concludes that the provisions in the proposed rule 
should be applicable to activities that are intrastate in character. 
The plain language of section 416(a)(2) of the FD&C Act defines the 
term ``transportation'' as any movement in commerce by motor vehicle or 
rail vehicle. Section 416(b) of the FD&C Act directs FDA 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. Section 416 does not include a 
limitation to interstate commerce. FDA seeks comment on whether the 
provisions should be applicable to activities that are intrastate in 
character.
3. Activities Outside the United States
    This proposed rule sets forth sanitary transportation practices for 
shippers, carriers, and receivers who transport food that will be 
consumed or distributed in the United States. However, some food may 
enter the United States and be transported within the United States but 
not be consumed or distributed into the U.S. market. For example, some 
food is transshipped from a foreign country through the United States 
to a different country (e.g., food that is driven from Mexico through 
the United States into Canada). In addition, food may be imported into 
the United States, transported to a facility for further processing, 
and exported to another country without being consumed or distributed 
in U.S. commerce.
    We have tentatively concluded that section 416 of the FD&C Act is 
not intended to apply to the transportation of food that is neither 
consumed nor distributed in the United States. Therefore, proposed 
Sec.  1.900(b) would provide that the requirements of subpart O do not 
apply to shippers, receivers, or carriers when they are engaged in 
transportation operations of: (1) Food that is transshipped through the 
United States to another country; or (2) food that is imported for 
future export and that is neither consumed nor distributed in the 
United States.
    However, the proposal would apply to the transportation operations 
of food that will be directly transported into the United States by 
motor or rail vehicle. By contrast, the requirements of this proposal 
would not apply to the transportation operations of food that may 
ultimately be intended for U.S. commerce, but will not be directly 
transported into the United States by motor or rail vehicle. For 
example, the requirements of this proposed rule would apply to a 
shipper and carrier who conduct a transportation operation abroad that 
includes direct shipment of the food into the United States by motor 
vehicle or rail vehicle (e.g., food that is shipped from Mexico by 
truck and that will enter the United States on that truck and be 
transported further within the United States). However, the 
requirements of this proposed rule would not apply to a shipper and 
carrier who conduct a transportation operation abroad for food that is 
ultimately intended for the United States, other than the direct 
shipment of the food to the United States by motor or rail vehicle 
(e.g., food that is shipped, carried, and received within China but 
that will ultimately be transported to the United States by air). As a 
further example, the requirements of this proposed rule would also 
apply to a person outside of the United States, such as an exporter, 
who ships food to the United States in an international freight 
container by oceangoing vessel or in an air freight container, and 
arranges for the transfer of the intact container in the United States 
onto a motor vehicle or rail vehicle for transportation in U.S. 
commerce, if that food will be consumed or distributed in the United 
States. We would consider this person to be a shipper under this 
proposed rule because he would be initiating a shipment of food by 
motor vehicle or rail vehicle, even if doing so from abroad, that would 
be entering U.S. commerce. If that shipper fails to comply with the 
requirements of this proposed rule and FDA determines that food shipped 
to the United States by that shipper may as a result be adulterated, 
such shipments of food would be subject to refusal of admission when 
offered for entry into the United States.
4. Other Requirements Applicable to Food Transportation
    Proposed Sec.  1.900 would also provide that the requirements of 
subpart O apply in addition to any other requirements of FDA that are 
applicable to food transportation. For example, FDA has established 
regulations setting forth current good manufacturing practices (CGMP) 
for medicated animal feeds in part 225 (21 CFR part 225), which include 
a provision in section 225.65 ``Equipment and cleanout procedures,'' 
that addresses requirements for the cleaning of equipment used in the 
distribution of medicated feeds to avoid

[[Page 7011]]

unsafe contamination of feeds with drugs. Similarly, FDA has 
established regulations addressing substances prohibited from use in 
animal food or feed in part 589 (21 CFR part 589), which include 
provisions in Sec. Sec.  589.2000 ``Animal proteins prohibited in 
ruminant feed'' and 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.

B. Applicability (Proposed Sec.  1.902)

    Under section 402(i) of the FD&C Act (21 U.S.C. 342(i)), a food 
shall be deemed to be 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 2005 SFTA.
    Proposed Sec.  1.902(a) would provide that the criteria and 
definitions of subpart O apply in determining whether food is 
adulterated within the meaning of section 402(i) of the FD&C Act in 
that the food has been transported or offered for transport by a 
shipper, carrier by motor vehicle or rail vehicle, or receiver engaged 
in the transportation of food under conditions that are not in 
compliance with subpart O.
    Under section 301(hh) of the FD&C Act, the following act, and the 
causing thereof, is prohibited: 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 sanitary transportation 
practices prescribed by the Secretary under section 416. To clearly 
communicate that failure to comply with regulations established under 
section 416 of the FD&C Act is a prohibited act, proposed Sec.  
1.902(b) would provide that the failure by a shipper, carrier by motor 
vehicle or rail vehicle, or receiver engaged in food transportation 
operations to comply with the requirements of subpart O is a prohibited 
act under section 301(hh) of the FD&C Act.

C. Definitions (Proposed Sec.  1.904)

    Proposed Sec.  1.904 would define ``adequate'' as that which is 
needed to accomplish the intended purpose in keeping with good public 
health practice. This proposed definition is identical to the 
definition for this term in the existing CGMP regulations (see 21 CFR 
110.3(b)). We have retained this definition in the proposed updates to 
the CGMP provisions of the proposed preventive controls rule for human 
food and have also included the same definition in the CGMP provisions 
of the proposed preventive controls rule for animal food. Given the 
broad applicability of this term in describing essential principles and 
practices for the sanitary handling of food, we have tentatively 
concluded that using this term to express relevant requirements in this 
proposed rule, e.g., transportation equipment must be designed to be 
``adequately'' cleanable, will be understood by industry and will be 
effective in ensuring that food is not transported under conditions 
that may render it adulterated. Several provisions of this proposed 
rule are comparable (see Table 1) to provisions of our CGMP regulations 
and reflect established principles of sanitary operations involving 
food, whether those operations are carried out in a food facility or in 
a food transportation operation. As a result, many firms are likely to 
already be in compliance with the proposed provisions of this rule.

      Table 1--Provisions of This Proposed Rule That Are Comparable to Provisions of FDA's CGMP Regulations
----------------------------------------------------------------------------------------------------------------
            Provision                        As proposed in this rule                   Comparable to CGMP
----------------------------------------------------------------------------------------------------------------
Sec.   1.904....................  Defines ``adequate'' as that which is needed   21 CFR 110.3(b)--``Adequate
                                   to accomplish the intended purpose in          means that which is needed to
                                   keeping with good public health practice.      accomplish the intended
                                                                                  purpose in keeping with good
                                                                                  public health practice.''
Sec.   1.906(b).................  Requires that vehicles and transportation      21 CFR 110.40(a)--``All plant
                                   equipment be maintained in such a sanitary     equipment and utensils shall
                                   condition as to prevent the food that they     be so designed and of such
                                   transport from becoming filthy, putrid,        material and workmanship as to
                                   decomposed, or otherwise unfit for food, or    be adequately cleanable, and
                                   being rendered injurious to health from any    shall be properly
                                   source during transportation operations.       maintained.''
Sec.   1.906(c).................  Requires that vehicles and transportation      21 CFR 110.80(b)(6)--``Food
                                   equipment that are used in transportation      that can support the rapid
                                   operations for food that can support the       growth of undesirable
                                   rapid growth of undesirable microorganisms     microorganisms, particularly
                                   in the absence of temperature control during   those of public health
                                   transportation be designed, maintained, and    significance, shall be held in
                                   equipped, to maintain the food under           a manner that prevents the
                                   temperature conditions that will prevent the   food from becoming adulterated
                                   rapid growth of undesirable microorganisms.    within the meaning of the
                                                                                  act.''
Sec.   1.906(d).................  Requires that each freezer and mechanically    21 CFR 110.40(e)--``Each
                                   refrigerated cold storage compartment in       freezer and cold storage
                                   vehicles or transportation equipment used in   compartment used to store and
                                   transportation operations for food that can    hold food capable of
                                   support the rapid growth of undesirable        supporting growth of
                                   microorganisms in the absence of temperature   microorganisms shall be fitted
                                   control during transportation be equipped      with an indicating
                                   with an indicating thermometer, temperature-   thermometer, temperature-
                                   measuring device, or temperature-recording     measuring device, or
                                   device so installed as to show the             temperature-recording device
                                   temperature accurately within the              installed to show the
                                   compartment.                                   temperature accurately within
                                                                                  the compartment . . . ''

[[Page 7012]]

 
Sec.   1.906(e).................  Requires that vehicles and transportation      21 CFR 110.35(e)--``Cleaned and
                                   equipment be stored in such a manner as to     sanitized portable equipment
                                   prevent the vehicles or transportation         with food-contact surfaces and
                                   equipment from harboring pests or becoming     utensils should be stored in a
                                   contaminated in any other manner that could    location and manner that
                                   result in food for which they will be used     protects food-contact surfaces
                                   becoming filthy, putrid, decomposed, or        from contamination.''
                                   otherwise unfit for food, or being rendered
                                   injurious to health from any source during
                                   transportation operations.
Sec.   1.908(a)(2)..............  Requires that responsibility for ensuring      21 CFR 110.10(d)--
                                   that transportation operations are carried     ``Responsibility for assuring
                                   out in compliance with all requirements of     compliance by all personnel
                                   subpart O be assigned to competent             with all requirements of this
                                   supervisory personnel.                         part shall be clearly assigned
                                                                                  to competent supervisory
                                                                                  personnel.''
Sec.   1.908(c)(1)..............  Requires that shippers and receivers provide   21 CFR 110.10(b)--``All persons
                                   vehicle operators who are expected to handle   working in direct contact with
                                   food not completely enclosed by a container    food, food-contact surfaces,
                                   during loading and unloading operations with   and food-packaging materials
                                   access to a hand-washing facility that is      shall conform to hygienic
                                   convenient and that provides running water.    practices while on duty to the
                                                                                  extent necessary to protect
                                                                                  against contamination of
                                                                                  food.''
                                                                                 21 CFR 110.10(b)(3)--``Washing
                                                                                  hands thoroughly (and
                                                                                  sanitizing if necessary to
                                                                                  protect against contamination
                                                                                  with undesirable
                                                                                  microorganisms) in an adequate
                                                                                  hand-washing facility . . .''
                                                                                 21 CFR 110.37(e)--``Hand-
                                                                                  washing facilities shall be
                                                                                  adequate and convenient and be
                                                                                  furnished with running water
                                                                                  at a suitable temperature.''
----------------------------------------------------------------------------------------------------------------

    Proposed Sec.  1.904 would define ``animal food'' as food for 
animals other than man, and includes pet food, feed, and raw materials 
and ingredients. This definition is identical to the definition of 
``animal food'' in the proposed preventive controls rule for animal 
food.
    Proposed Sec.  1.904 would define a ``bulk vehicle'' as 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. This proposed definition is taken directly from section 
416(a)(1) of the FD&C Act (21 U.S.C. 350e(a)(1)). This definition 
differentiates a subset of motor vehicles and rail vehicles subject to 
this proposed rule, i.e., ``bulk vehicles,'' from other types of 
vehicles subject to this proposed rule, i.e., non-bulk vehicles such as 
trailers. As discussed in section III.E, we have proposed to establish 
several specific requirements applicable to transportation operations 
involving bulk vehicles to ensure that food is adequately protected 
from adulteration during such operations.
    This proposed definition would include equipment used in food 
transportation because they are attached to and carried on a motor or 
rail vehicle, e.g., a cargo tank. We tentatively conclude that defining 
bulk vehicles as we have proposed would ensure that the provisions of 
this rule relating to bulk vehicles apply to all possible 
transportation operations in which food is hauled in bulk conveyances, 
ranging from tank trucks to cargo tanks.
    Proposed Sec.  1.904 would define a ``carrier'' as a person who 
owns, leases, or is otherwise ultimately responsible for the use of a 
motor vehicle or rail vehicle to transport food. This definition would 
further provide that the carrier is responsible for all functions 
assigned to a carrier in subpart O even if they are performed by other 
persons, such as a driver that is either employed or contracted by a 
trucking firm to operate the vehicle. Furthermore, a carrier may also 
be a receiver or a shipper if the person also performs the functions of 
those respective persons as defined in subpart O.
    The transportation of food may be carried out in different ways 
that involve different entities. For example, a manufacturing facility 
that does not have its own private truck fleet, drivers, or contracted 
drivers may enter into a contract of carriage with a trucking company 
for the trucking company to physically transport a food shipment using 
the trucking company's vehicle to another facility designated in the 
contract. In another instance, a distributor who has possession of the 
food in a holding facility may operate leased vehicles to deliver food 
to his customers. In both of these examples, the entity ultimately 
responsible for the use of the vehicle that transports the food, i.e., 
the trucking company in the first case and the distributor in the 
second case, would be subject to the requirements applicable to the 
carrier under this proposed rule. In the second case, the distributor 
may also be subject to additional requirements applicable to shippers 
under this proposed rule due to his operation of the holding facility.
    This proposed definition would provide that the carrier is 
responsible for all functions assigned to that person in subpart O, 
even if they are performed by other persons such as a driver that is 
employed or contracted by the carrier. Thus the carrier, being the 
entity ultimately responsible for the use of the vehicle to physically 
transport food, would be responsible for ensuring that a driver, who 
operates the vehicle, functions in a manner that enables the carrier to 
comply with all of his responsibilities under this proposed rule. For 
example, after a transportation operation, the carrier may under 
proposed Sec.  1.908(d)(2), discussed in section III.E, provide a log 
of temperature measurements to the shipper to demonstrate that it has 
maintained temperature conditions during the transportation operation 
consistent with those specified by the shipper in accordance with 
proposed Sec.  1.908(b)(3). In practice, the driver of the vehicle 
would likely be the person who compiles or retrieves this log from the 
temperature recording device; however it would be the responsibility of 
the carrier to ensure that the driver actually compiles or retrieves 
the log as

[[Page 7013]]

part of his duties during the transportation operation and makes it 
available to be provided to the shipper.
    The definition of the term ``carrier'' acknowledges the potential 
distinction between the carrier, who is the entity responsible for the 
use of the vehicle, from the operator of the vehicle. The Federal Motor 
Carrier Safety Administration, part of DOT, makes a similar distinction 
in its federal motor carrier safety regulations (49 CFR part 390) which 
define a ``driver'' as any person who operates a commercial motor 
vehicle and specify that a driver could be employed by a motor carrier 
(49 CFR 390.5). These regulations also hold motor carriers responsible 
for, among other things, the oversight of drivers. We have acknowledged 
the potential for a distinction between the carrier and the driver for 
the purpose of placing the responsibilities assigned to the carrier 
under this proposed rule upon a single person. Further, we have 
tentatively concluded that placing these responsibilities on a single 
person will help to avoid any confusion regarding who is responsible 
for the requirements for carriers set forth in this proposed rule.
    Proposed Sec.  1.904 would define ``cross-contact'' to mean the 
unintentional incorporation of a food allergen as defined in section 
201(qq) of the FD&C Act (21 U.S.C. 321(qq)) into food, except animal 
food. We are proposing to establish essentially the same definition for 
the term ``cross-contact'' that we included in the proposed preventive 
controls rule for human food (see discussion in 78 FR 3646 at 3693), 
except that we are adding the term ``except animal food'' to our 
proposed definition because, as discussed in the preamble of the 
proposed preventive controls rule for animal food (78 FR 64736 at 
64771, October 29, 2013), we are not aware of evidence indicating that 
foodborne allergens pose a significant health risk to animals, or to 
humans through handling animal food.
    Proposed Sec.  1.904 would define ``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. Further, we 
are proposing that the term ``farm'' includes 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. Our proposed definition of the term ``farm'' differs from 
the definition of a farm in Sec.  1.227(b)(3) of this chapter, which is 
used to delineate which entities are required to register under section 
415 of the FD&C Act. The reason why we are proposing to define a farm 
differently for the purposes of this proposed rule is discussed in our 
proposed definition for ``transportation operations'' later in this 
section.
    Proposed Sec.  1.904 would define ``food'' to mean food as defined 
in section 201(f) of the FD&C Act, which includes raw materials and 
ingredients. This definition is identical to the definition of ``food'' 
in the proposed preventive controls rules for human and animal food. To 
ensure that the reader understands the scope of food covered by this 
proposed rule, this definition provision would also state consistent 
with the definition of ``food'' in the FD&C Act, food includes animal 
food and food subject to the Federal Meat Inspection Act, the Poultry 
Products Inspection Act, and the Egg Products Inspection Act \1\ 
administered by the Food Safety and Inspection Service (FSIS) of the 
USDA.
---------------------------------------------------------------------------

    \1\ FDA notes that, to prevent duplication of effort, its 
compliance policy is to inform FSIS when an apparent violation is 
encountered involving a meat or poultry product that has left a USDA 
inspected establishment (Ref. 12).
---------------------------------------------------------------------------

    FSIS carries out in-commerce surveillance activities to verify that 
entities whose business activities involve FSIS-regulated products 
prepare, store, transport, sell, offer for sale or transportation, 
import, and export such products in compliance with FSIS statutory and 
regulatory requirements. FSIS has issued guidance for the safe 
transportation and distribution of meat, poultry and egg products (Ref. 
11), however, they do not have requirements that directly address 
transportation operations for these foods. This rulemaking will 
complement FSIS's efforts to promote the application of sanitary food 
transportation practices for FSIS-regulated meat, poultry, and egg 
products. We intend to work together with FSIS to facilitate this 
shared objective while carrying out our respective regulatory programs.
    Proposed Sec.  1.904 would define ``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. This 
proposed definition is used to designate a category of food that is 
subject to specific provisions of this proposed rule intended to ensure 
that such food is not potentially rendered adulterated during 
transportation because it is at increased risk of contamination due to 
being exposed to the environment. This definition provision includes 
examples of such containers such as an open wooden basket or crate, an 
open cardboard box, a vented cardboard box with a top, or a vented 
plastic bag. The definition also provides that this term does not 
include food transported in a bulk vehicle as defined in this proposed 
rule.
    This approach is consistent with how we addressed unexposed 
refrigerated packaged foods in the proposed preventive controls rules 
for human and animal food. For instance in the proposed preventive 
controls rule for human food we stated that some of the requirements of 
that rule would not apply to facilities solely engaged in the storage 
of packaged foods not exposed to the environment (78 FR 3646 at 3713), 
and instead proposed to establish modified requirements for such foods 
that are TCS foods (78 FR 3646 at 3773). In that proposed rule we 
stated that we considered ``unexposed packaged food,'' to mean packaged 
food not exposed to the environment (78 FR 3646 at 3712).
    In considering how unexposed packaged food should be addressed in 
the human preventive controls rule we recognized that in general, there 
are limited routes of contamination for unexposed packaged food due to 
the protective nature of the food's packaging (78 FR 3646 at 3713). The 
same was stated in the proposed preventive controls rule for animal 
food (provide FR cite when published). In this proposed rule, we 
recognize that the converse is true, i.e., we are recognizing that food 
not completely enclosed by a container is at greater risk of 
contamination during transportation, and as such, we tentatively 
conclude that it is appropriate to propose certain requirements that 
apply exclusively to such food.
    Proposed Sec.  1.904 would define ``microorganisms'' to mean 
yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites 
and includes species having public health significance. Proposed Sec.  
1.904 would also specify that the term ``undesirable microorganisms'' 
includes 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. This proposed definition is identical to the definition 
for this term in the proposed preventive controls rules for human and 
animal food. Because they can adulterate food, we consider the types of 
microorganisms identified in this proposed definition to be of 
importance to sanitary transportation of foods as well as to the safe 
and sanitary production of human and animal food.

[[Page 7014]]

    Proposed Sec.  1.904 would define ``non-covered business'' as a 
shipper, receiver, or carrier engaged in transportation operations that 
has less than $500,000 in total annual sales.
    Our proposed definition for a non-covered business is similar to 
one of the proposed definitions for a very small business in the 
proposed preventive controls rule for human food for which we requested 
comment (78 FR 3646 at 3701). Under that proposed rule a very small 
business would be subject to modified requirements that include 
provisions for an exemption from the requirements for hazard analysis 
and preventive controls. We are proposing to exclude these businesses 
from coverage under this rule to provide for comparable treatment of 
these firms between this proposed rule and the proposed preventive 
controls rules. Additionally, for firms that only function as carriers 
and thus would not be subject to the proposed preventive controls 
rules, excluding carriers with less than $500,000 in total annual sales 
from coverage by this proposed rule would treat carriers in a manner 
consistent with the treatment of shippers and receivers subject to this 
proposed rule. We estimate that not covering carriers with less than 
$500,000 in total annual sales would still result in an average of 97 
percent of all food shipments by motor vehicle or rail being subject to 
this proposed rule. We note that a non-covered business is and will 
continue to be covered under the adulteration provisions and other 
applicable provisions of the FD&C Act and applicable implementing 
regulations, irrespective of whether that business is included within 
the scope of this proposed rule. We are requesting comment on whether 
the foods that comprise the $500,000 in total annual sales should be 
limited in some way, such as to those subject to this rule or to any of 
the FSMA rules when finalized.
    Proposed Sec.  1.904 would define ``pest'' to mean any 
objectionable animals or insects including birds, rodents, flies, and 
larvae. This proposed definition is identical to the definition for 
this term in the proposed preventive controls rule for human food. That 
proposed rule also includes a discussion, which is relevant to this 
proposal, of some circumstances under which animals would not be 
considered ``objectionable'' (78 FR 3646 at 3721). We consider the 
types of pests identified in this proposed definition to be of 
importance to sanitary transportation of foods as well as to the safe 
and sanitary production of human and animal food.
    Proposed Sec.  1.904 would define ``receiver'' to mean any person 
who receives food after transportation, whether or not that person 
represents the final point of receipt for the food. This definition 
also states that a receiver may also be a carrier or a shipper if the 
person also performs the functions of those respective persons as 
defined in this proposed rule. Proposed Sec.  1.904 would also provide 
that a receiver does not include an individual consumer or a person who 
receives or holds food on behalf of an individual consumer and who is 
not also a party to the transaction and who is not in the business of 
distributing food, e.g., such as a hotel concierge or the reception 
desk in an apartment building who is not holding the food for 
commercial purposes.
    Within the transportation industry, shippers may direct goods to 
receivers in a single segment trip wherein the shipment proceeds 
directly to the ultimate consignee, or in multi-segment trips that 
proceed through intermediate destinations, such as a temporary storage 
point. Therefore, this proposed definition will provide that all 
persons who receive food after transportation, not just the ultimate 
consignee, are subject to the requirements applicable to receivers in 
this proposed rule.
    Proposed Sec.  1.904 would define ``shelf-stable food'' 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. We based this proposed 
definition on several inherently similar definitions of this term in 
the literature (Ref. 13) (Ref. 14) (Ref. 15) (Ref. 16). This definition 
provision would also provide some examples of shelf stable food, 
including canned juice, canned vegetables, canned meat, bottled water, 
and dry food items.
    Proposed Sec.  1.904 would define ``shipper'' to mean a person who 
initiates a shipment of food by motor vehicle or rail vehicle. This 
definition further provides that the shipper is responsible for all 
functions assigned to a shipper in subpart O 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. For example, a 
produce distributor (the shipper) may initiate a shipment of food by 
arranging for a carrier to pick up a shipment of fresh produce at a 
holding facility for transport by truck to a produce distribution 
facility hundreds of miles away. Employees of the holding facility who 
are not employed by the distributor may load the produce onto the 
truck. Under this proposed rule, the distributor would be responsible, 
e.g., through contractual arrangements, for ensuring that the employees 
of the holding facility visually inspect the vehicle for cleanliness 
and determine that it appears to be in appropriate sanitary condition 
for the transport of the food, as required by proposed Sec.  
1.908(b)(2), discussed in section III.E, and that all other 
requirements of this proposed rule are met. We believe that 
periodically reviewing and updating contractual relationships is a 
common and regular industry practice.
    This definition also states that a shipper may also be a carrier or 
a receiver if the shipper also performs the functions of those 
respective persons as defined in subpart O, e.g., a supermarket chain 
may arrange for the shipment of fresh produce to be received at its 
distribution center.
    We have defined the term ``shipper'' in this manner to place the 
responsibilities assigned to shippers, discussed in section III.E, upon 
a single person, the initiator of a transportation operation, as we 
expect this person to be knowledgeable about all factors concerning the 
food, e.g., its packaging and holding temperature requirements, 
relevant to its sanitary transport. We have tentatively concluded that 
defining shipper in this manner will ensure that food is not 
transported under conditions that may render it adulterated and also 
that placing these responsibilities on a single person will help to 
avoid any confusion regarding who is responsible for the requirements 
of a shipper set forth in this proposed rule.
    Proposed Sec.  1.904 would define ``small business'' to mean ``a 
business, subject to proposed Sec.  1.900(a) (discussed in section 
III.A) employing 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 proposed Sec.  1.900(a) having less 
than $25,500,000 in annual receipts, consistent with the size based 
standard that has been established by the U.S. Small Business 
Administration for truck transportation firms.'' The proposed limit of 
500 employees would include all employees of the business rather than 
be limited to the employees at a particular facility. For all persons 
subject to this rule except carriers by motor vehicle, we are proposing 
to establish the same definition for a small business as 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 part 
121 for most food manufacturers. For carriers by motor vehicle, we are 
proposing to establish essentially the same definition for a

[[Page 7015]]

small business as the size based standard (expressed in terms of 
millions of dollars) that has been established by the U.S. Small 
Business Administration under 13 CFR part 121 for truck transportation 
firms. The definition of a small business affects what the compliance 
date is for such entities.
    Proposed Sec.  1.904 would define ``Time/Temperature Control for 
Safety Food (TCS Food)'' as a food that requires time/temperature 
control for safety to limit pathogenic microorganism growth or toxin 
formation. This proposed definition is identical to that for the term 
``Potentially Hazardous Food (Time/Temperature Control for Safety 
Food)'' in the 2009 Edition of FDA's Food Code (Ref. 17) and this term, 
having the same meaning, is also used within the proposed preventive 
controls rules for human and animal food (78 FR 3646 at 3712 and 78 FR 
64736 at 64768).
    Proposed Sec.  1.904 would define ``transportation'' as any 
movement of food in commerce by motor vehicle or rail vehicle. This 
proposed definition is identical to the definition of this term in 
section 416(a)(2) of the FD&C Act except that we added the words ``of 
food'' for clarity.
    Proposed Sec.  1.904 would define ``transportation equipment'' to 
mean equipment used in transportation operations, other than vehicles, 
e.g., bulk and non-bulk containers, bins, totes, pallets, pumps, 
fittings, hoses, gaskets, and loading and unloading systems and also 
state that transportation equipment would also include a railcar not 
attached to a locomotive or a trailer not attached to a tractor. We 
tentatively conclude that this definition, which encompasses all of the 
basic types of equipment that may be used in food transportation, is 
necessary to help ensure the safe transportation of food. The examples 
of transportation equipment in this definition are not all inclusive, 
but are broadly representative of the types of equipment used in food 
transportation as identified in the ERG report and in comments to the 
2010 ANPRM.
    Proposed Sec.  1.904 would define ``transportation operations'' to 
mean all activities associated with food transportation that may affect 
the sanitary condition of food including the cleaning, inspection, 
maintenance, loading and unloading of, and operation of vehicles and 
transportation equipment. This proposed definition would further 
provide that transportation operations do not include any activities 
associated with the transportation solely of shelf stable food that is 
completely enclosed by a container, compressed food gases, or live food 
animals.
    As noted previously in this section, section 416(a)(2) of the FD&C 
Act defines ``transportation'' to mean any movement in commerce by 
motor vehicle or rail vehicle. In establishing this definition of 
``transportation operations,'' we intend to more precisely define the 
scope of certain requirements of this proposed rule by distinguishing 
between activities that occur in association with food transportation 
that may render the food adulterated and other activities that do not 
pose this potential. The requirements of this proposed rule would only 
apply to those activities that may render the food adulterated if 
carried out in an insanitary manner. An example of such an activity 
would be the transfer of juice from a bulk tank truck into a receiver's 
stationary storage tanks. An example of an activity that would not be 
considered to be a transportation operation under this proposed rule 
would be the filling of a vehicle's fuel tank while it is transporting 
food.
    In addition, the proposed definition of transportation operations 
would exclude activities associated with the transportation of shelf 
stable food that is completely enclosed by a container, compressed food 
gases, and live food animals. We have tentatively concluded that shelf 
stable foods completely enclosed by a container are at little risk of 
adulteration during transportation. They do not require temperature 
control and as such, are not at risk of microbial spoilage or the 
growth of microorganisms of public health significance, and they are 
not directly exposed to the transportation environment due to their 
being fully enclosed by their container, e.g., a metal can, a glass or 
plastic bottle, or a sealed bag or box. Therefore, we have tentatively 
concluded that requirements for sanitary transportation practices do 
not need to apply to such foods.
    Comments to the 2010 ANPRM (Ref. 18) (Ref. 19) stated that 
compressed food gases such as carbon dioxide used for carbonating 
beverages, are transported in cylinders or bulk containers or in bulk 
vehicles such as trailers or railcars that are dedicated to the 
transport of a single product. These comments also stated that 
compressed food gases do not support microbial growth and are 
transported under pressure in containers and vehicles that protect 
against chemical and physical contamination because they have no man-
holes and only provide for exit and entry through valving. As such, we 
have tentatively concluded that compressed food gases are at little 
risk for adulteration during transport due to the manner in which they 
are transported and are proposing to exclude such foods from the scope 
of these requirements.
    We are not aware of food safety concerns related to the 
transportation of live food animals intended for slaughter that could 
be addressed through the sanitary transportation practices set forth in 
this proposed rule. No comments to the 2010 ANPRM raised any such 
concerns. Furthermore, slaughter operations at facilities subject to 
FSIS jurisdiction are subject to requirements intended to minimize the 
risk of adulteration posed by the presence of contaminants on the 
external surfaces of live food animals. Therefore, we have tentatively 
concluded that sanitary transportation practices are not necessary to 
prevent live food animals from becoming adulterated during 
transportation, and are proposing to exclude such foods from the scope 
of these requirements.
    We are specifically requesting comment on our tentative conclusion 
that shelf stable food that is completely enclosed by a container, 
compressed food gases, and live food animals should be excluded from 
the scope of this proposed rule.
    Further, the proposed definition of transportation operations would 
exclude transportation activities for RACs that are performed by a 
farm. We use the term raw agricultural commodities as it is defined in 
section 201(r) of the FD&C Act. We discuss the meaning of the term in 
the proposed rule for preventive controls for human food (78 FR 3646 at 
3678). Previously in this section, we proposed that, for the purposes 
of this proposed rule, the term ``farm'' means ``a facility in one 
general physical location devoted to the growing and harvesting of 
crops, the raising of animals (including seafood), or both'' and that 
the term ``includes 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.'' For purposes 
of this proposed regulation, a farm could be a facility that also 
performs activities other than the growing and harvesting of crops and 
the raising of animals; however, only transportation activities for raw 
agricultural commodities would be excluded from the proposed definition 
of transportation operations.
    We note previously in this section that the definition of the term 
``farm'' in this proposed rule differs from the definition of a farm in 
Sec.  1.227(b)(3) of this chapter. The definition of a farm in

[[Page 7016]]

Sec.  1.227(b)(3) applies only to facilities that pack or hold food if 
the food used in such activities was grown, raised, or consumed on that 
farm or a farm under the same ownership. The definition in Sec.  
1.227(b)(3) was developed for the purposes of implementing the 
registration requirements of section 415 of the FD&C Act. However, as 
discussed further in the paragraphs that follow, we have tentatively 
concluded that 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 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, and therefore have concluded that a 
different definition of the term ``farm'' for the purposes of this 
proposed rule is necessary.
    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 proposed rule. No 
comments to the 2010 ANPRM raised any such concerns. Specifically, we 
are not aware of instances in which insanitary conditions or practices 
(e.g., improper temperature control, improper equipment construction, 
inadequate equipment cleaning) with regard to transportation operations 
conducted by farms involving the transportation of RACs have 
contributed to foodborne illness. We note that this is the case 
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 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 broadly suitable for this sector. Therefore, 
we have 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, and are proposing to exclude such foods from 
the scope of these requirements.
    The proposed exclusion is intended to apply to the activities of 
farms, regardless of whether the farm is serving in the role of 
shipper, carrier, or receiver. We acknowledge 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. 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. 20). Building on industry experience we have 
tentatively concluded that the requirements of this proposed regulation 
should apply to such carriers with regard to the transportation of RACs 
from farms.
    We are specifically requesting comment on our tentative conclusion 
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. Further, we are requesting 
comment on whether the definition of ``transportation operations'' 
should include TCS raw agricultural commodities (e.g., sprouts, raw 
molluscan shellfish) because the temperature control requirements of 
these commodities warrant coverage under this proposed rule, and if so, 
what requirements would be appropriate.
    Proposed Sec.  1.904 would define ``vehicle'' to mean 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. We 
are proposing a broad definition of vehicle in order to encompass all 
of the types of motorized and rail conveyances that may be used in food 
transportation to ensure that all such conveyances are subject to the 
provisions of this proposed rule. Although a trailer is not motorized, 
we would consider a trailer to be a vehicle when attached to a tractor 
and used for food transportation because the trailer functions as part 
of the conveyance. Similarly, railcars would be considered to be 
vehicles when attached to a locomotive. The examples of vehicles in 
this definition are not all inclusive, but are broadly representative 
of the types of land conveyances used in food transportation as 
identified in the comments to the 2010 ANPRM.

D. Vehicles and Transportation Equipment (Proposed Sec.  1.906)

    Proposed Sec.  1.906(a) would require that the design of vehicles 
and transportation equipment used in transportation operations, the 
materials used in their manufacture, and their workmanship be suitable 
and that they be adequately cleanable for their intended use to prevent 
the food that they transport from becoming filthy, putrid, decomposed 
or otherwise unfit for food, or being rendered injurious to health from 
any source during transportation operations.
    Comments we received in response to the 2010 ANPRM stated that 
vehicles and transportation equipment are generally made to meet 
industry and third party standards for sanitary fabrication, design, 
and construction. For example, a comment stated that standards for 
coatings may require that they maintain corrosion resistance, and be 
free of surface delamination, pitting, flaking, chipping, blistering, 
and distortion under conditions of intended use. However, vehicles and 
transportation equipment that are poorly designed can be a source of 
contamination of food during transport. For example, food contact 
surface coatings on vehicles or transportation equipment that are not 
corrosion resistant or are flaking or chipping, for example, could 
contaminate food transported in bulk, due to chemical contamination or 
by causing the food to become unfit, and would render the vehicles or 
equipment as not suitable for their intended use.
    Similarly, vehicles and transportation equipment that are not 
adequately cleanable can be a source of contamination of food during 
transport. For example, wood containers used to hold raw meat or 
poultry during transportation typically cannot be brought to a sanitary 
condition to hold ready to consume produce during transportation due to 
the potential for the wood to retain contaminants such as harmful 
microorganisms in its porous structure (Ref. 21). Thus, wood containers 
used to hold ready to consume produce after their use to hold raw meat 
or poultry could be a source

[[Page 7017]]

of contamination of the produce and FDA would not consider such 
containers to be adequately cleanable for the transportation of produce 
following the transportation of raw meat or poultry.
    We have tentatively concluded that proposed Sec.  1.906(a) is 
consistent with best practices that have been established within the 
food transportation industry relative to vehicle and equipment design 
based upon the preceding discussion and the comments to the 2010 ANPRM.
    Proposed Sec.  1.906(b) would require that vehicles and 
transportation equipment be maintained in such a sanitary condition as 
to prevent the food that they transport from becoming filthy, putrid, 
decomposed, or otherwise unfit for food, or being rendered injurious to 
health from any source during transportation operations. Vehicles and 
transportation equipment that are not maintained in a sanitary 
condition can become a source of contamination of food or of allergens 
being incorporated into food through cross-contact during transport 
(Ref. 1). For example, FDA would not consider equipment used in bulk 
food transfer operations, such as pumps and hoses, to be maintained in 
an appropriate sanitary condition if the equipment was not cleaned 
after its use in handling milk, because this failure could lead to the 
incorporation of milk (a major food allergen) through cross-contact 
into food that was subsequently handled on the equipment. We note that 
proposed Sec.  1.906(b) would be consistent with measures routinely 
practiced within the juice industry to avoid the incorporation of 
allergens into juice by cross contact (Ref. 22).
    Similarly, FDA would not consider pallets to be maintained in an 
appropriate sanitary condition if they are in such poor repair, e.g., 
jagged wood edges, that they could damage food packaging causing a loss 
of container integrity and increasing the potential that the food is 
directly contaminated. We note that proposed Sec.  1.906(b) would also 
be consistent with pallet control measures practiced within the food 
transportation industry as described in a comment to the 2010 ANPRM 
which stated that pallets used within food distribution centers are 
cleaned and rotated or disposed of on a regular basis.
    Furthermore, proposed Sec.  1.906(b) is consistent with FDA's CGMP 
regulations in part 110 (21 CFR part 110) (see Sec.  110.40(a) and 
Table 1) and the CGMP provisions of the proposed preventive controls 
rules for human and animal food that require that equipment and 
utensils in food plants be properly maintained. As such, proposed Sec.  
1.906(b) would similarly apply sanitary maintenance requirements to 
food transportation vehicles and equipment as such requirements have 
been and will continue to be applied to equipment and utensils that are 
used to produce food in facilities.
    Proposed Sec.  1.906(c) would require that vehicles and 
transportation equipment used in transportation operations for food 
that can support the rapid growth of undesirable microorganisms in the 
absence of temperature control during transportation (any food that 
requires time/temperature control either to ensure its safety or to 
prevent microbial spoilage, e.g., meat, poultry, seafood, raw seed 
sprouts, unpasteurized shell eggs, or pasteurized juice) be so 
designed, maintained, and equipped to be able to maintain the food 
under temperature conditions that will prevent it from supporting such 
microbial growth. As discussed previously, FDA is proposing in Sec.  
1.904 that the term ``undesirable microorganisms'' includes 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.
    The use of vehicles and transportation equipment not designed, 
maintained, or otherwise equipped to maintain food under appropriate 
temperature conditions can, if used to transport TCS foods result in 
increased levels of microorganisms capable of causing human illness, 
and cause such foods to be adulterated. For instance, temperature 
control is used to minimize the growth of pathogens in TCS foods such 
as Salmonella enteritidis (SE) in unpasteurized shell eggs and Listeria 
monocytogenes, Salmonella spp., and other pathogens in other TCS foods 
(Ref. 17) (Ref. 23) (Ref. 24) (Ref. 25) (Ref. 26). Given this, we 
tentatively conclude that certain temperature controls are necessary to 
prevent TCS food from becoming adulterated during transportation.
    In addition, the use of vehicles and transportation equipment not 
designed, maintained, or otherwise equipped to maintain food under 
appropriate temperature conditions can, if used to transport foods 
subject to microbial spoilage, result in food spoilage and cause such 
foods to be adulterated. For example, some foods that are pasteurized 
to ensure their safety are not processed to be shelf-stable. These 
pasteurized foods would still require refrigeration during 
transportation to prevent the spoilage of the food due to the growth of 
non-pathogenic spoilage microorganisms. For instance, pasteurized 
citrus juice (this term as used in this proposal excludes shelf-stable 
juice) requires refrigeration during distribution to control the growth 
of non-pathogenic spoilage microorganisms that are not killed by the 
pasteurization process, e.g., yeasts and lactobacilli (Ref. 27) (Ref. 
28). Given this, we tentatively conclude that certain temperature 
controls are necessary to prevent food subject to microbial spoilage 
from becoming adulterated during transportation.
    We continue to receive reports or otherwise learn of foods, such as 
meat and some seafood products, that require time/temperature control 
to ensure their safety, as well as foods subject to microbial spoilage 
if temperature abused, being transported in unrefrigerated vehicles not 
otherwise equipped, e.g., with insulated coolers and ice packs, to 
maintain the food under appropriate temperature conditions (Ref. 5) 
(Ref. 6) (Ref. 7) (Ref. 8). We would consider unrefrigerated vehicles 
or equipment used to transport foods requiring temperature control to 
prevent the growth or undesirable microorganisms to comply with 
proposed Sec.  1.906(c) only if they incorporate design features such 
as thermal insulation for maintaining food in a chilled state or are 
otherwise equipped to maintain the food under appropriate temperature 
conditions, e.g., with insulated coolers and ice packs.
    The intent of proposed Sec.  1.906(c) is consistent with our CGMP 
regulations in part 110 (see Sec.  110.80(b)(6) and Table 1) and the 
proposed preventive controls rules for human and animal food that 
require that food subject to these respective regulations that can 
support the rapid growth of undesirable microorganisms be held at 
temperatures that will prevent the food from becoming adulterated 
during prescribed operations. Proposed Sec.  1.906(c) would apply 
appropriate holding temperature requirements to food transportation 
vehicles and equipment as such requirements have been and will continue 
to be applied to facilities in which food is produced.
    Proposed Sec.  1.906(d) would require that each freezer and 
mechanically refrigerated cold storage compartment in vehicles or 
transportation equipment used in transportation operations for food 
that can support the rapid growth of undesirable microorganisms in the 
absence of temperature control during transportation be equipped with 
an indicating thermometer, temperature-

[[Page 7018]]

measuring device, or temperature-recording device so installed as to 
show the temperature accurately within the compartment. This proposed 
requirement would provide a means by which the shipper, receiver or 
carrier, through checking the compartment temperature during the 
operation, can ensure as required by proposed Sec.  1.908(a)(3)(iii) 
(discussed in section III.E), that the temperature conditions during 
the transportation operation are such that the operation meets the 
requirements of proposed Sec.  1.908(a)(3) and are adequate to ensure 
that the food is not rendered adulterated during transportation. 
Furthermore, this proposed requirement would provide a means by which a 
shipper could verify before loading food that each freezer and 
mechanically refrigerated cold storage compartment or container offered 
by a carrier has been pre-cooled in accordance with information 
submitted by the shipper, as required by proposed Sec.  1.908(b)(4) 
(discussed in section III.E). This proposed requirement would also 
provide a means by which officials carrying out transportation safety 
inspections can, along with other inspectional observations, assess 
whether the transportation operation is being carried out in accord 
with proposed Sec.  1.908(a)(3) (discussed in section III.E).
    The intent of proposed Sec.  1.906(d) is consistent with FDA's CGMP 
regulations in part 110 (see Sec.  110.40(e) and Table 1) and the 
proposed preventive controls rules for human and animal food that 
require that each freezer and cold storage compartment used to store 
and hold food capable of supporting growth of microorganisms be fitted 
with an indicating thermometer, temperature-measuring device, or 
temperature-recording device installed to show the temperature 
accurately within the compartment. As such, proposed Sec.  1.906(d) 
would establish requirements for food temperature displaying devices 
for food transportation vehicles and equipment as such requirements 
have been and will continue to be applied to facilities in which food 
is produced.
    Proposed Sec.  1.906(e) would require that vehicles and 
transportation equipment be stored in such 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. Vehicles and transportation equipment 
that harbor pests or are otherwise contaminated while they are stored 
can contaminate food during transport if the vehicles and equipment 
cannot be adequately cleaned before being used for the transport of 
food. For example, FDA would not consider trucks, railcars, or 
containers stored in such a manner that they could develop persistent 
rodent populations in food holding areas to meet the requirements of 
proposed Sec.  1.906(e).
    The requirements of proposed Sec.  1.906(e) clearly represent a 
sanitary transportation practice and we have tentatively concluded that 
these requirements are necessary to ensure that food is not transported 
under conditions that may render it adulterated. Furthermore, the 
intent of this provision is consistent with our CGMP regulations in 
part 110 (see Sec.  110.35(e) and Table 1) that recommend that cleaned 
and sanitized portable equipment with food-contact surfaces and 
utensils be stored in a location and manner that protects food-contact 
surfaces from contamination.

E. Transportation Operations (Proposed Sec.  1.908)

1. General Requirements
    Proposed Sec.  1.908(a) would set forth general provisions and 
requirements applicable to transportation operations.
    Proposed Sec.  1.908(a)(1) would provide that the requirements of 
proposed Sec.  1.908 apply to all shippers, carriers, and receivers 
engaged in transportation operations unless specifically stated 
otherwise. We have included this provision to make it clear that unless 
a requirement of proposed Sec.  1.908 specifically only applies to 
shippers, receivers or carriers, the requirement applies to all of 
these persons.
    Proposed Sec.  1.908(a)(2) would require that responsibility for 
ensuring that transportation operations are carried out in compliance 
with all requirements of subpart O be assigned to competent supervisory 
personnel. Proposed Sec.  1.908(a)(2) is intended to ensure that 
shippers, receivers, and carriers engaged in food transportation 
operations will identify the requirements they must meet under this 
proposed rule and establish accountability at the individual level for 
ensuring that transportation operations are carried out in compliance 
with those requirements and in a way that prevents food from becoming 
adulterated during transportation. This provision mirrors a 
longstanding provision in the current CGMP regulation regarding the 
manufacturing, processing, packing, or holding of human food (see Sec.  
110.10(d) and Table 1) and essentially equivalent provisions in the 
proposed preventive controls for both human and animal food, which 
require that competent supervisory personnel be assigned responsibility 
for ``assuring'' (or ``ensuring,'' in the case of the two proposed 
rules) compliance with the requirements of the regulations.
    Proposed Sec.  1.908(a)(3) would require that all transportation 
operations be conducted under such conditions and controls as are 
necessary to prevent the food that they are transporting from becoming 
filthy, putrid, decomposed, or otherwise unfit for food, or being 
rendered injurious to health from any source during transportation 
operations.
    This proposed provision sets forth circumstances under which we 
envision that food could be rendered adulterated as a result of 
contamination or insanitary conditions that could occur during a 
transportation operation. For example, if animal feed became 
contaminated by glass fragments during transport in an inadequately 
cleaned bulk vehicle, FDA would consider that the transportation 
operation was not conducted under conditions and controls necessary to 
prevent the food from being rendered injurious to animal health. 
Similarly, if a product such as shell eggs, which requires 
refrigeration during transportation to ensure its safety, was left 
unattended for several hours on a loading dock on a warm day, FDA would 
consider that the receiving stage of the transportation operation was 
not conducted under conditions and controls necessary to prevent the 
food from being rendered injurious to human health. Further, if 
pasteurized citrus juice became spoiled during transport due to 
inadequate refrigeration of the product, FDA would consider that the 
transportation operation was not conducted under conditions and 
controls necessary to prevent the food from becoming unfit for food.
    Proposed Sec.  1.908(a)(3)(i), (a)(3)(ii), and (a)(3)(iii) would 
identify specific actions that persons engaged in transportation 
operations must take to ensure that the operation complies with the 
requirements of proposed Sec.  1.908(a)(3).
    Proposed Sec.  1.908(a)(3)(i) would require that persons take 
effective measures such as segregation or isolation to protect food 
from contamination during transportation operations by raw foods and 
non-food items in the same load. The failure to take effective 
measures, e.g., the proper loading of raw and ready to consume foods, 
to protect food from contamination during transportation

[[Page 7019]]

operations by raw foods and non-food items in the same load can lead to 
conditions, such as the dripping of raw poultry onto open containers of 
fresh produce, that could result in the adulteration of unprotected 
food by filth, chemical, or microbial contaminants (Ref. 3) (Ref. 5).
    We received a number of comments to the 2010 ANPRM that asserted 
that food transporters routinely safely transport food and non-food 
items in the same load. We agree with these comments that this can be 
safely accomplished as long as appropriate practices, such as those 
that the industry has developed to ensure that food is adequately 
protected from contamination by non-food items on the same load, are 
consistently followed. These practices vary within the industry as 
discussed in the comments to the 2010 ANPRM. For example, in some 
operations, non-food items transported in the same load with food are 
placed in sealed containers with seamless bottoms. These non-food items 
are then placed on pallets that hold only non-food items. In other 
operations, non-food items may be directly stacked in their shipping 
boxes on pallets that hold only non-food items. In other operations, 
food and non-food items may be stacked on the same pallet, with the 
non-food items being positioned below the food items on the pallet so 
that if any containers of the non-food items were damaged or improperly 
sealed, their contents would not leak onto food. FDA would consider 
these practices to be effective in protecting food from contamination, 
as required by proposed Sec.  1.908(a)(3)(i), if the non-food items are 
isolated by their packaging and the load is properly secured in the 
vehicle or shipping container. However, we would consider the 
transportation of food with non-food items that are not protectively 
packaged or that are loaded into a vehicle or a shipping container in a 
non-secured manner whereby the non-food item could contaminate food as 
a failure to take effective measures to protect food from contamination 
as proposed Sec.  1.908(a)(3)(i) would require.
    Further, as stated in the discussion of proposed Sec.  1.906(c) in 
section III.D, we continue to receive or otherwise learn of reports of 
the improper loading of trucks carrying raw animal foods and ready to 
eat foods resulting in observable cross-contamination of ready to eat 
food items during transportation, e.g., the dripping of raw meat juices 
onto fresh produce (Ref. 4) (Ref. 5) (Ref. 7). For example, we would 
regard the loading of vehicles or portable containers in a manner that 
could allow for the contamination of ready to eat food by raw animal 
foods as a failure to take effective measures to protect food from 
contamination by raw foods as required by proposed Sec.  
1.908(a)(3)(i).
    Proposed Sec.  1.908(a)(3)(ii) would require that persons engaged 
in transportation operations take 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.
    The failure to take effective measures to protect foods that are 
exposed to the environment, that may be contacted by handlers of the 
shipment, or that directly contact a vehicle from contamination or 
cross-contact during transportation operations could result in the 
adulteration of the unprotected food by filth, chemical, or microbial 
contaminants or by allergens. We recognize that food transporters 
routinely safely transport foods in bulk vehicles and foods not 
completely enclosed by a container. We believe that this fact is 
substantially attributable to the practices the industry has developed 
as described in comments to the 2010 ANPRM to ensure that vehicles and 
containers used in the transport of such foods are cleaned and are in 
appropriate sanitary condition when offered for food transport and to 
ensure that sanitary procedures are employed during loading and 
unloading operations. However, we have tentatively concluded that 
persons engaged in transportation operations must also consider other 
factors related to their transportation operations to completely ensure 
that exposed or bulk-shipped foods are not adulterated during 
transport.
    For example, a shipper of ready to consume fresh produce items that 
will not be completely enclosed by a container when shipped may, to 
protect the shipment, require by contractual arrangement that a carrier 
who intends to make additional pickups during the transportation 
operation only load other fresh produce items or items packaged in 
sealed containers onto the vehicle containing his shipment. To comply 
with proposed Sec.  1.908(a)(3)(ii), the shipper and the carrier must 
ensure that such protective measures are taken in order to avoid 
contamination of the raw produce during transportation.
    Furthermore, a driver of a vehicle transporting fresh produce items 
not completely enclosed by a container may be expected to handle 
containers during unloading. If during transport, the driver had to 
address a vehicle problem such as changing a flat tire, the driver's 
hands may have become soiled or contaminated with grease; in such a 
situation, this provision would require the driver to wash his or her 
hands before handling the containers of produce to reduce the potential 
for the food to become contaminated during handling.
    Moreover, a firm that ships corn syrup by bulk tanker may use 
different carriers for their shipments, some of which may also haul 
milk and some of which only haul corn syrup. To ensure that milk, a 
food allergen, is not introduced into the corn syrup during transport 
through cross-contact, that shipper might establish different 
operational procedures for shipments to be transported by these 
respective carriers. For transportation operations using the carrier 
who also transports milk, the shipper could have the operator of each 
incoming tanker provide a wash ticket and also have the wash station 
operator apply a seal on access points to the tanker after cleaning. 
For the carrier that only hauls corn syrup, the shipper may choose to 
rely on the carrier's contractual assurance that only tankers dedicated 
to hauling corn syrup and cleaned at a mutually agreed frequency will 
be offered. The shipper would comply with proposed Sec.  
1.908(a)(3)(ii) if the shipper took measures, such as those discussed 
previously, to ensure that the corn syrup is not adulterated by 
contamination or cross-contact during transport. We note that, to 
facilitate the conduct of bulk transportation operations in a sanitary 
manner, proposed Sec.  1.908(d)(4) and (d)(5), discussed in more detail 
in section III.E.4., would establish provisions regarding the 
disclosure to shippers of information about prior cargoes and 
subsequent vehicle cleaning by carriers that transport food in bulk 
vehicles.
    Proposed Sec.  1.908(a)(3)(iii) would require persons to ensure 
that food that can support the rapid growth of undesirable 
microorganisms in the absence of temperature control during 
transportation (see examples in the discussion of proposed Sec.  
1.906(c)) is transported in a manner, including the 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.
    The provisions of this proposed rule and the proposed preventive 
controls rules for human and animal food are intended to function in a 
complementary manner to address the transportation of foods that 
require time/temperature control to control the growth of 
microorganisms that may cause illness.

[[Page 7020]]

    The importance of maintaining temperature control during the 
transportation of TCS foods and foods subject to microbial spoilage if 
held under inadequate temperature control was addressed in the 
discussion of proposed Sec.  1.906(c) in section III.D. For a TCS food 
that would be subject to either of the proposed preventive controls 
rules, if failure to provide adequate temperature control during 
transportation could result in a food safety hazard, in most cases, the 
owner, operator, or agent in charge of the facility that manufactures, 
processes, packs or holds the food would be responsible for 
establishing preventive controls for the food to prevent the occurrence 
of that hazard (78 FR 3646 at 3737, 3744, and 3773; 78 FR 64736 at 
64784). Therefore, we have tentatively concluded that a person subject 
to either of the proposed preventive controls regulations would (when 
those regulations become final) be required to identify and take the 
steps necessary for that person to comply with proposed Sec.  
1.908(a)(3)(iii).
    As previously noted, pasteurized citrus juice is an example of a 
non-TCS food that requires temperature control during distribution to 
control the growth of non-pathogenic spoilage microorganisms, which, in 
the case of juice, may not be killed by the pasteurization process. If 
such a food is not maintained under temperature conditions to prevent 
the food from undergoing microbial spoilage and becoming unfit for 
food, such food may become adulterated during transport. However, the 
specific temperature conditions necessary to prevent the food from 
undergoing microbial spoilage would depend upon the interaction of 
numerous factors concerning the food and its holding conditions that is 
sufficiently complex such that it is not possible to establish broadly 
applicable temperature conditions under which such foods must be held 
during transportation to prevent the microbial spoilage of the food. 
Therefore, we are not proposing to establish specific temperature 
requirements for non-TCS foods subject to proposed Sec.  
1.908(a)(3)(iii).
    However, under proposed Sec.  1.908(a)(3)(iii), persons subject to 
this proposed rule must provide adequate temperature control during 
transportation operations as necessary to control the growth of 
undesirable microorganisms. Persons engaged in transportation 
operations that result in the transportation of non-TCS food subject to 
microbial spoilage e.g., pasteurized juice, under conditions of 
inadequate temperature control, would not meet the requirements of 
proposed Sec.  1.908(a)(3)(iii), and we may deem the food to be 
adulterated under section 402(i) of the FD&C Act in that the food has 
been transported under conditions that are not in compliance with the 
sanitary food transportation regulations.
    With respect to frozen foods, in the preamble of the proposed 
preventive controls rule for human food (78 FR 3646 at 3774), FDA 
stated that 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. We noted that although there 
have been occasional problems with frozen food being subject to 
temperatures that allow some thawing in storage and distribution, we 
are not aware of situations in which frozen foods have been associated 
with the food becoming unsafe. Thus, we stated that we believe that it 
would be rare for a frozen food product to be a TCS food.
    However, the same considerations discussed previously regarding the 
transportation of pasteurized juice apply to the transportation of 
frozen food. The transportation of frozen food under conditions of 
inadequate temperature control or temperature abuse whereby the food 
could undergo microbial spoilage would not comply with proposed Sec.  
1.908(a)(3)(iii), and we may deem the food to be adulterated under 
section 402(i) of the FD&C Act in that the food has been transported 
under conditions that are not in compliance with the sanitary food 
transportation regulations.
    Finally, some foods that are typically transported under 
temperature control are not at risk of becoming adulterated if 
temperature control is not provided. An example of such a food would be 
fruit, such as bananas, that is transported under temperature control 
to delay ripening for marketability purposes. FDA would not consider 
bananas and other foods that are similar in this regard and typically 
transported under temperature control solely for marketability purposes 
to be food that can support the rapid growth of undesirable 
microorganisms in the absence of temperature control and these foods 
therefore would not be subject to proposed Sec.  1.908(a)(3)(iii).
2. Requirements Applicable to Shippers
    Proposed Sec.  1.908(b) would set forth requirements applicable to 
shippers engaged in transportation operations.
    Proposed Sec.  1.908(b)(1) would require that the shipper 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 deemed necessary by the 
shipper, to ensure that the vehicle and equipment are 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. Proposed Sec.  1.908(b)(1) would 
also provide that the information submitted by the shipper to the 
carrier is subject to the records requirements in proposed Sec.  
1.912(a).
    Proposed Sec.  1.908(b)(1) and similar requirements in this 
proposed rule (i.e., proposed Sec.  1.908(b)(3), (d)(2), (d)(4), and 
(d)(5)) would address the provision of information by one party engaged 
in transportation operations to another party. Section 416(c)(1)(D) of 
the FD&C Act (21 U.S.C. 350e(c)(1)(D)) provides that, in issuing these 
regulations, the Secretary (and by delegation, FDA) must prescribe such 
practices as the Secretary determines appropriate relating to, among 
other things, information to be disclosed to a carrier by a person 
arranging for the transport of food and to a manufacturer or other 
person that arranges for the transportation of food by a carrier or 
furnishes a tank vehicle or bulk vehicle for the transportation of 
food. Proposed Sec.  1.908(b)(1) establishes requirements for the 
information to be disclosed by a shipper to carrier that FDA has 
determined is necessary to ensure that food is not transported under 
conditions that would render the food adulterated. We discuss 
additional information sharing requirements for shippers and carriers 
in sections that follow.
    Carriers in the food transportation industry commonly use standard 
procedures to deploy and prepare vehicles and transportation equipment 
to transport food. For example, comments to the 2010 ANPRM noted that 
thermally insulated tankers are used to haul foods that require 
temperature control. These tankers are typically designed and built to 
comply with industry standards that control the degree to which the 
temperature of the food will increase in a given amount of time. In 
addition, comments to the 2010 ANPRM stated that dry trailers used to 
haul non-refrigerated, fully packaged food items are swept or vacuum 
cleaned before being offered for loading. There are, however, 
circumstances in which a shipper may determine that specific procedures 
are necessary to prepare the vehicle or transportation equipment to 
ensure that they are in appropriate sanitary condition for the 
transport of a

[[Page 7021]]

particular food product. For example, shippers of fresh produce in non-
enclosed containers may determine that a standard power washing 
procedure for a refrigerated trailer with a sanitization procedure is 
necessary to remove and treat any residues from a previous load that 
could contaminate the shipment. Shippers of animal feed may determine 
that special flushing procedures are necessary for bulk vehicles that 
have previously hauled medicated feed before being used for a feed 
shipment.
    We have tentatively concluded that the identification by a shipper 
of the necessary sanitary requirements for vehicles and transportation 
equipment is essential for ensuring that the vehicle or transportation 
equipment to be provided by the carrier is appropriate for the intended 
transportation operation, particularly considering that certain types 
of foods, e.g., foods shipped in bulk or not completely enclosed by a 
container, may necessitate specific preparation procedures for the 
vehicle or transportation equipment. Proposed Sec.  1.908(b)(1) would 
assign this responsibility to the shipper because we have tentatively 
concluded that the shipper is in the best position to know the 
characteristics of the food to be shipped that may necessitate the 
provision of specific features for the vehicle or transportation 
equipment, e.g., thermally insulated construction of a tank, or that 
may necessitate specific preparation steps by the carrier, e.g., a 
specific wash procedure, to ensure that the vehicle or transportation 
equipment is in appropriate sanitary condition for the transportation 
operation. We have also tentatively concluded that requiring the 
shipper to communicate this information to the carrier in writing is 
necessary to ensure that the shipper identifies the necessary sanitary 
requirements for the vehicle and equipment and to enable the carrier to 
take any necessary steps in deploying and preparing vehicles or 
transportation equipment for the operation.
    Based upon comments we received in response to the 2010 ANPRM, we 
understand that in accordance with best industry practices, shippers 
and carriers frequently exchange information about requirements for 
vehicles, transportation equipment, and cleaning procedures. 
Accordingly, we do not believe that proposed Sec.  1.908(b)(1) would 
require substantial efforts beyond those which are already common 
within the food transportation industry.
    Given the importance of ensuring that vehicles and transportation 
equipment are in appropriate sanitary condition when offered for the 
transportation of food, proposed Sec.  1.908(b)(1) would also provide 
that the shipper's written specification to the carrier of sanitary 
requirements for vehicles and transportation equipment is subject to 
the records requirements of proposed Sec.  1.912(a) (discussed in 
section III.G).
    Proposed Sec.  1.908(b)(2) would require that, before loading food 
not completely enclosed by a container onto a vehicle or into 
transportation equipment, e.g., a shipping container, provided by a 
carrier, the shipper must visually inspect the vehicle or the 
transportation equipment provided by the carrier for cleanliness and 
determine that the vehicle or transportation equipment is in 
appropriate sanitary condition for the transport of the food. The 
proposal would provide the following example of what constitutes 
``appropriate sanitary condition for the transport of food'': the 
vehicle or transportation equipment is free of visible evidence of pest 
infestation and of debris, previous cargo, or dirt that could cause the 
food to become adulterated.
    In the previous discussion of proposed Sec.  1.908(a)(3)(ii) in 
this section we discussed the necessity to take effective measures 
during transportation operations to protect from adulteration foods 
that are not completely enclosed by a container and thus are exposed to 
potential contamination from the environment. Providing such protection 
depends in part upon ensuring that vehicles and transportation 
equipment in which such food will be transported are in adequate 
sanitary condition so that they will not become a source of 
contamination for the exposed food. We tentatively conclude that a pre-
loading visual inspection by the shipper of the vehicle or 
transportation equipment provided by the carrier for cleanliness to 
determine that it is in appropriate sanitary condition for the 
transport of the food as would be required by proposed Sec.  
1.908(b)(2) is necessary to ensure that the transportation operation 
will be conducted in accord with sanitary transportation practices.
    Several comments received in response to the 2010 ANPRM stated that 
pre-loading inspections are commonly carried out in transportation 
operations. One comment from a food retailers association stated that 
in such an inspection, for example, a trailer that exhibited any signs 
of mold, mildew, animal droppings, excess water, ice buildup, pest 
contamination or any holes, cracks or other breaches of the trailer 
itself that constituted conditions under which food may become 
contaminated would not generally be considered to be in an appropriate 
sanitary condition for the transport of food.
    Proposed Sec.  1.908(b)(3) would require that a shipper of 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, specify in writing to the carrier, except a 
carrier who transports the food in a thermally insulated tank, the 
temperature conditions necessary during the transportation operation, 
including the pre-cooling phase, to ensure that the operation will 
maintain the temperature conditions and meet the requirements of 
proposed Sec.  1.908(a)(3).
    As previously noted in our discussion of proposed Sec.  
1.908(a)(3)(iii), various types of food require temperature control 
during transport either to prevent the food from becoming unsafe due to 
the growth of harmful microorganisms or to prevent the growth of non-
harmful spoilage microorganisms. The shippers of such foods are 
generally expected to know the temperature control needs for these 
foods during transport. For example, our regulations for the prevention 
of SE in shell eggs during production, storage, and transportation in 
Sec.  118.4(e) and for the refrigeration of shell eggs held for retail 
distribution in Sec.  115.50(b)(2)) require eggs to be held and 
transported at a temperature not to exceed 45 [deg]F (7 [deg]C).
    We tentatively conclude that specification by the shipper to the 
carrier of the temperature conditions necessary during the 
transportation operation, including the pre-cooling phase, is necessary 
to ensure that the operation will meet the requirements of proposed 
Sec.  1.908(a)(3) with respect to the maintenance of appropriate 
temperature conditions for the food, and that the shipper is in the 
best position to identify the necessary temperature conditions because 
the shipper has the most knowledge and information about the food being 
offered for transport. We have also tentatively concluded, however, 
that such specification by the shipper would not be necessary for 
shipments of food in a thermally insulated tank because thermally 
insulated tanks are designed and built to limit the degree of 
temperature increase of a food in a given amount of time, and the 
shipper would specify the need for such a vehicle under the 
requirements of proposed Sec.  1.908(b)(1). We have also tentatively 
concluded that requiring that the shipper make this communication to 
the carrier in writing would ensure that the shipper considers these 
temperature requirements for the food and explicitly communicates them 
to the carrier who can then implement the specified

[[Page 7022]]

temperature conditions during the transportation operation.
    We expect that the information provided by shippers to carriers 
would identify appropriate holding temperatures for food to be shipped 
consistent with considerations about the food we have discussed in 
section III.D and in this section with respect to proposed Sec. Sec.  
1.906(c) and 1.908((a)(3)(iii). Shippers who would be subject to the 
proposed preventive controls rules for human food or animal food would 
know the appropriate holding temperatures for any food for which 
failure to adequately control temperature during transportation could 
make the food unsafe.
    For non-TCS foods subject to microbial spoilage if not properly 
temperature controlled, as we noted previously in this section in the 
discussion of proposed Sec.  1.908(a)(3)(iii), because of the complex 
interaction of factors that influence microbial spoilage in foods, we 
are not proposing to establish specific temperature requirements for 
non-TCS foods subject to proposed Sec.  1.908(a)(3)(iii) and (b)(3). 
Under proposed Sec.  1.908(b)(3), shippers of such foods would inform 
the carrier of the temperature control requirements for the food based 
upon their determination of the temperature conditions necessary to 
ensure that the product does not become adulterated due to the growth 
of spoilage microorganisms.
    Based upon comments we received in response to the 2010 ANPRM, we 
understand that in accordance with best industry practices, shippers 
frequently inform carriers about temperature conditions necessary 
during transportation operations. Accordingly, proposed Sec.  
1.908(b)(3) should be consistent with efforts already commonly used 
within the food transportation industry.
    Given the importance of ensuring that food is maintained under 
adequate temperature control during transportation, we tentatively 
conclude that the shipper should be able to demonstrate, through 
records, that it has specified, in writing to the carrier e.g., in a 
contract of carriage, the necessary temperature conditions for the 
food. The records will demonstrate that, within the shipper/carrier 
relationship, appropriate attention is given to maintaining the 
necessary temperature control during transportation operations to 
ensure that food does not become adulterated. Proposed Sec.  
1.908(b)(3) would also provide that the shipper's written specification 
to the carrier of the necessary temperature conditions for the food 
during the transportation operation is subject to the records 
requirements of proposed Sec.  1.912(a) (discussed in section III.G).
    Proposed Sec.  1.908(b)(4) would require that, before loading food, 
a shipper of food that can support the rapid growth of undesirable 
microorganisms in the absence of temperature control during 
transportation must verify that each freezer and mechanically 
refrigerated cold storage compartment or container has been pre-cooled 
in accordance with information submitted by the shipper as required by 
proposed Sec.  1.908(b)(3).
    In the previous discussions of proposed Sec. Sec.  1.906(c) and 
1.908(a)(3)(iii) in section III.D, we discussed the importance of 
providing temperature control during transportation operations for TCS 
foods and other foods subject to microbial spoilage, to ensure that 
these types of food do not become unsafe or otherwise adulterated. 
Providing adequate temperature control may depend in part upon the 
adequate pre-cooling of vehicles and containers into which the food 
will be loaded. If a refrigerated trailer has not been adequately pre-
cooled at the time it is loaded with food, the temperature of the food 
may increase above levels necessary to ensure the safe and sanitary 
transport of the food until such time that the refrigeration unit 
brings the food to an acceptable temperature. Therefore, proposed Sec.  
1.908(b)(4) would require the shipper to conduct a pre-loading 
verification of a vehicle's or shipping container's pre-cooling to 
ensure that food is not transported under conditions that may render 
the food adulterated.
    Based upon comments we received in response to the 2010 ANPRM, we 
understand that in accordance with best industry practices, pre-loading 
verification by shippers of the pre-cooling of refrigerated vehicles 
and containers is commonly carried out in transportation operations 
(although we understand that during such a verification check, the 
refrigeration system may be turned off when its doors are open, e.g., 
in humid conditions, to prevent water condensation on surfaces such as 
fiberboard packages that could be damaged by the water). Accordingly, 
we do not believe that the requirement placed on the shipper by 
proposed Sec.  1.908(b)(4) would require substantial efforts beyond 
those which are already common within the food transportation industry.
    Proposed Sec.  1.908(b)(5) would provide that the shipper assumes 
the requirements applicable to the carrier in proposed Sec.  
1.908(d)(2)(i) (discussed later in this section) with respect to 
providing a demonstration to the receiver, if the shipper and carrier 
have agreed in writing pursuant to proposed Sec.  1.908(d)(2)(ii) (also 
discussed later in this section) that the shipper is responsible for 
ensuring that the food was held under acceptable temperature conditions 
during transportation operations. Proposed Sec.  1.908(b)(5) would also 
provide that the shipper assumes the corresponding records requirements 
applicable to the carrier under proposed Sec.  1.908(d)(6)(ii) and 
proposed Sec.  1.912(c) (also discussed later in this section).
    We refer the reader to the discussion in this section of the 
requirement in proposed Sec.  1.908(d)(2)(i) that the carrier 
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. Proposed 
Sec.  1.908(d)(2)(ii) would discharge the carrier from this requirement 
if the carrier and shipper agree, in writing and before transportation 
operations, that the shipper is responsible for monitoring the 
temperature conditions or otherwise assuring that the food was held 
under acceptable temperature conditions during the transportation 
operation.
    In the circumstance addressed by proposed Sec.  1.908(d)(2)(ii), 
e.g., a shipment by refrigerated rail car wherein the shipper controls 
the operation of the refrigeration equipment in a leased rail car, 
inasmuch as the shipper would be assuming responsibilities otherwise 
assigned to the carrier under this proposed rule, proposed Sec.  
1.908(b)(5) would make it clear that the shipper is also required to 
provide to the receiver, if requested, the specified demonstration that 
would have otherwise been provided by the carrier. Proposed Sec.  
1.908(b)(5) also makes it clear that the shipper assumes the 
corresponding records requirements that would otherwise be applicable 
to the carrier under proposed Sec. Sec.  1.908(d)(6)(ii) and proposed 
Sec.  1.912(b). Proposed Sec.  1.908(b)(5) thus would ensure that the 
shipper is subject to the same requirements to provide information to 
the receiver, and the same corresponding records requirements as the 
carrier would otherwise be, in circumstances where the shipper has 
assumed a responsibility that would otherwise be borne by the carrier.
3. Requirements Applicable to Shippers and Receivers
    Proposed Sec.  1.908(c) would set forth requirements applicable to 
both shippers and receivers engaged in transportation operations.

[[Page 7023]]

    Proposed Sec.  1.908(c)(1) would require that shippers and 
receivers provide vehicle operators who are expected to handle food not 
completely enclosed by a container during loading and unloading 
operations with access to a hand-washing facility that is convenient 
and that provides running water. This would ensure that the operator's 
hands are not a source of contamination of food by providing facilities 
that are convenient and furnish running water. As noted in the 
discussion of proposed Sec.  1.908(a)(3)(ii) previously in this 
section, a driver of a vehicle transporting food items not completely 
enclosed by a container may be expected to handle containers during 
unloading. If, for example, during transport, the driver had to change 
a tire, the driver's hands could become soiled or contaminated with 
grease such that it would be necessary for that driver to wash his 
hands before handling the containers of produce to reduce the potential 
for the food to become contaminated during handling. Proposed Sec.  
1.908(c)(1) would require the shipper or receiver to provide access to 
an adequate hand-washing facility if the driver is expected to handle 
the food being transported to ensure that the operator's hands are not 
a source of contamination of food.
    Proposed Sec.  1.908(c)(1) is consistent with our existing CGMP 
regulations which include a provision on cleanliness whereby persons 
working in direct contact with food must conform to hygienic practices 
(see Sec.  110.10(b), (b)(3) and 110.37(e) and Table 1). These hygienic 
practices include washing hands thoroughly and sanitizing if necessary 
to protect against contamination with undesirable microorganisms (Sec.  
110.10(b)(3)). This regulation also includes provisions that address 
the hand-washing facilities that must be available to personnel (see, 
e.g., Sec.  110.37(e)). Furthermore, the proposed preventive controls 
rules for both human and animal food contain similar hygiene provisions 
for hand-washing facilities. For example, the CGMP provisions of both 
proposed preventive controls rules would establish a performance 
standard that would require that each plant provide hand-washing 
facilities designed to ensure that an employee's hands are not a source 
of contamination of food (human or animal), food-contact surfaces, or 
food packaging materials by providing facilities that are adequate, 
convenient, and furnish running water at a suitable temperature (78 FR 
3646 at 3723; 78 FR 64736 at 64774).
    Proposed Sec.  1.908(c)(2) would require that shippers and 
receivers of food that can support the rapid growth of undesirable 
microorganisms in the absence of temperature control during 
transportation carry out loading and unloading operations under 
conditions that will prevent the food from supporting such microbial 
growth. During any period of temperature abuse foods that can support 
the rapid growth of undesirable microorganisms may experience 
conditions whereby they may develop increased levels of microorganisms 
capable of causing spoilage of the food, or if present, microorganisms 
that may cause human or animal illness. While some comments to the 2010 
ANPRM stated that the docking areas of some shipping and receiving 
facilities are temperature monitored, a comment stated such temperature 
monitoring is not always practiced during loading and unloading 
operations for refrigerated and frozen foods. Nevertheless, FDA has 
tentatively concluded that the movement of these foods through non-
temperature controlled loading and unloading areas would not put the 
food at risk of adulteration if the food is not held under conditions 
that may adversely affect the food's temperature for extended time 
periods. However, FDA would not consider staging and holding of any 
food capable of supporting the rapid growth of undesirable 
microorganisms in the absence of temperature control on a non-
temperature controlled loading dock hours before a pickup is scheduled 
to be an acceptable handling practice for such food under proposed 
Sec.  1.908(c)(2) because these conditions could cause the food to be 
rendered unsafe or otherwise adulterated.
4. Requirements Applicable to Carriers
    Proposed Sec.  1.908(d) would set forth requirements applicable to 
carriers engaged in transportation operations.
    Proposed Sec.  1.908(d)(1) would require that a carrier supply a 
vehicle and transportation equipment that meets any requirements 
specified by the shipper in accordance with proposed 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.
    In the discussion of proposed Sec.  1.908(b)(1) previously in this 
section, we discussed the importance of the shipper specifying to the 
carrier the necessary sanitary requirements for vehicles and 
transportation equipment to ensure that the vehicle or equipment to be 
provided by the carrier is appropriate for the intended transportation 
operation. We discussed that we have tentatively concluded that the 
shipper is in the most appropriate person to specify these requirements 
because he would best know the characteristics of the food to be 
shipped and any specific steps that should be taken by the carrier to 
ensure that the vehicle or transportation equipment is in appropriate 
sanitary condition for the transportation operation and to ensure that 
the food does not become adulterated during transportation.
    Because a vehicle that is not in appropriate sanitary condition 
when offered for the transportation of food can be a source of 
contamination of food during transport, we tentatively conclude that it 
is of equal importance to help ensure that food does not become 
adulterated during transportation that carriers provide vehicles and 
transportation equipment that meet the sanitary requirements specified 
by the shipper and are otherwise appropriate for the sanitary 
transportation of food. Therefore, proposed Sec.  1.908(d)(1) would 
make the carrier responsible for providing a vehicle that is in 
appropriate condition for the transportation of food, including meeting 
any requirements specified by the shipper in accordance with proposed 
Sec.  1.908(b)(1), to ensure that the food being transported will not 
become filthy, putrid, decomposed, or otherwise unfit for food, or be 
rendered injurious to health from any source during the transportation 
operation.
    For example, a carrier would not be considered to be in compliance 
with this proposed provision if it offers a bulk vehicle intended for 
the transport of animal feed for loading if it had previously been used 
to transport medicated feed and the carrier had not performed a 
cleanout procedure established by the shipper to remove residues of the 
medicated feed from the vehicle.
    Proposed Sec.  1.908(d)(2) would establish requirements for 
carriers relevant to the maintenance of temperature control for foods 
subject to proposed Sec.  1.908(b)(3) discussed previously in this 
section.
    Proposed Sec.  1.908(d)(2)(i) would require a carrier, once the 
transportation operation is complete, to demonstrate to the shipper and 
if requested, to the receiver, that the carrier maintained temperature 
conditions during the transportation operation consistent with those 
specified by the shipper in accordance with proposed Sec.  1.908(b)(3). 
Proposed Sec.  1.908(d)(2)(i) would further provide that this 
demonstration may be accomplished by any appropriate means agreeable to 
the carrier and shipper. For

[[Page 7024]]

example, the carrier could present printouts of a time/temperature 
recording device or a log of temperature measurements taken at various 
times during the shipment.
    As we noted in the discussion of proposed Sec.  1.908(b)(3), the 
specification by the shipper to the carrier of the temperature 
conditions necessary during the transportation operation, including the 
pre-cooling phase, is important for ensuring the maintenance of 
appropriate temperature conditions for the food during the operation. 
Proposed Sec.  1.908(b)(3) thus would require the shipper to make this 
specification to the carrier. Based upon comments we received in 
response to the 2010 ANPRM, we understand that shippers and carriers 
routinely exchange the type of information required by proposed Sec.  
1.908(b)(3) and furthermore, industry best practices have been 
developed for the maintenance of the cold chain.
    Nonetheless, the lack of appropriate temperature control is a 
potential problem in food transportation as evidenced by concerns about 
improper temperature control of food products cited in the ERG report 
and the continuing reports we have received of food transported without 
proper temperature control (Ref. 3) (Ref. 4) (Ref. 5) (Ref. 6) (Ref. 7) 
(Ref. 8) (Ref. 9). In light of these concerns, we propose to include a 
mechanism by which the carrier must demonstrate to the shipper that 
food which may become adulterated if its temperature is not properly 
controlled during transportation operations was transported under 
acceptable temperature conditions. Proposed Sec.  1.908(d)(2)(i) would 
require that a carrier demonstrate to the shipper, once the 
transportation operation is complete, that the carrier maintained 
temperature conditions during the transportation operation consistent 
with the shipper's specifications.
    Proposed Sec.  1.908(d)(2)(i) would further provide that the 
demonstration to be made by the carrier may be accomplished by any 
appropriate means agreeable to the carrier and shipper. This provision 
would allow the carrier to make this demonstration in different ways 
consistent with existing industry practices. For example, by agreement 
with a shipper of a TCS food, the carrier may use an onboard recording 
device to monitor compartment temperature in the vehicle during the 
transportation operation and provide the monitoring information to the 
shipper. Alternatively, by agreement with the shipper, the carrier may 
manually record the compartment temperatures in a log and provide the 
log to the shipper.
    The proper temperature control of food subject to the rapid growth 
of undesirable microorganisms in the absence of temperature control 
during transportation is also of importance to receivers because the 
carrier's failure to provide the necessary temperature control for the 
food may result in receivers receiving and then offering adulterated 
food to consumers or other customers. Therefore, proposed Sec.  
1.908(d)(2)(i) would state that the carrier, upon request by the 
receiver, must demonstrate to the receiver that the carrier maintained 
temperature conditions during the transportation operation consistent 
with the shipper's specifications.
    We recognize that in certain circumstances, a shipper may assume 
the responsibility for ensuring that food is held under acceptable 
temperature conditions during a transportation operation (Ref. 20). In 
such cases, proposed Sec.  1.908(d)(2)(ii) would provide that a carrier 
is not subject to the requirements of proposed Sec.  1.908(d)(2)(i) if 
the carrier and shipper agree in writing prior to the transportation 
operation that the shipper is 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. For example, in some cases the 
shipper may by agreement with the carrier arrange to have his own 
temperature monitoring device placed aboard the vehicle and recover the 
device upon delivery of the food.
    In another example, a shipper of pasteurized juice to be 
transported a short distance may rely on: (1) His pre-loading 
inspection to establish that the vehicle was properly pre-cooled; and 
(2) the receiver's inspection of the food upon delivery. This 
arrangement would be an alternative to the carrier providing a 
demonstration to the shipper if the shipper has determined that this 
procedure would ensure that the food was transported under acceptable 
temperature conditions.
    Thus, proposed Sec.  1.908(d)(2) would establish a flexible 
mechanism compatible with existing industry practices whereby the 
carrier is responsible for demonstrating to the shipper that the 
carrier has met the shipper's specified temperature conditions unless 
the carrier and shipper agree, in writing, that the shipper will be 
responsible for monitoring the temperature conditions or otherwise 
assuring that the food was held under acceptable temperature conditions 
during the operation.
    Proposed Sec.  1.908(d)(2)(ii) further would require the carrier to 
provide the written agreement to the receiver, if requested. This 
provision provides a practicable means for a carrier to notify a 
receiver that the shipper has assumed responsibility for ensuring that 
the food was held under acceptable temperature conditions during the 
transportation operation, should the receiver request that a carrier 
provide the demonstration required by proposed Sec.  1.908(d)(2)(i). As 
discussed previously in this section with respect to proposed Sec.  
1.908(b)(5), in such a situation, the shipper would assume the 
requirements otherwise applicable to the carrier in proposed Sec.  
1.908(d)(2)(i).
    We tentatively conclude, and have thus specified in proposed Sec.  
1.908(d)(2)(ii) that the agreement between the carrier and shipper 
should be written because the agreement transfers responsibilities 
otherwise assigned to the carrier under this proposed rule to the 
shipper, and requiring the agreement to be written would appropriately 
document that transfer of responsibility. Proposed Sec.  
1.908(d)(2)(ii) further specifies that the written agreement is subject 
to the records requirements of Sec.  1.912(b) of this subpart.
    Proposed Sec.  1.908(d)(3) would require that before offering a 
vehicle or transportation equipment with an auxiliary refrigeration 
unit for the transportation of food that can support the rapid growth 
of undesirable microorganisms in the absence of temperature control, a 
carrier must pre-cool each mechanically refrigerated freezer and cold 
storage compartment as specified by the shipper in accordance with 
proposed Sec.  1.908(b)(3).
    In the discussion of proposed Sec.  1.908(b)(3) previously in this 
section, we discussed our tentative conclusion that requiring the 
shipper to specify to the carrier the temperature conditions necessary 
during the transportation operation, including the pre-cooling phase, 
was necessary for ensuring that the operation will meet proposed Sec.  
1.908(a)(3) with respect to the maintenance of appropriate temperature 
conditions for the food. The shipper is able to specify these 
requirements because it is in the best position to know the temperature 
control requirements of the food to be shipped to ensure that the food 
does not become adulterated due to the undesirable microorganism 
growth. Proposed Sec.  1.908(b)(3) would thus make the shipper 
responsible for specifying these

[[Page 7025]]

temperature conditions to carrier in writing.
    A vehicle or transportation equipment that is not adequately pre-
cooled can, after loading, cause the food to exceed temperatures that 
are necessary to control microorganism growth. Therefore, proposed 
Sec.  1.908(d)(3) would require the carrier to pre-cool each 
mechanically refrigerated freezer and cold storage compartment as 
specified by the shipper in accordance with proposed Sec.  1.908(b)(3) 
before offering a vehicle or transportation equipment with an auxiliary 
refrigeration unit for the transportation of food that can support the 
rapid growth of undesirable microorganisms in the absence of 
temperature control. This proposed provision would only be applicable 
to vehicles or transportation equipment that maintain temperature 
control of food through the use of mechanically refrigerated freezers 
or cold storage compartments because for vehicles or transportation 
equipment that maintain temperature control by means other than 
mechanical refrigeration, e.g., thermally insulated bulk tankers, pre-
cooling is not necessary to ensure temperature control of the food 
after loading.
    Based upon comments we received in response to the 2010 ANPRM, we 
understand that in accordance with best industry practices, carriers in 
the industry generally pre-cool vehicles they intend to offer for the 
shipment of temperature controlled foods. Accordingly, we do not 
believe that the requirement placed on the carrier by proposed Sec.  
1.908(d)(3) will necessitate efforts beyond those which are already 
common within the food transportation industry.
    Proposed Sec.  1.908(d)(4) would require a carrier that offers a 
bulk vehicle for food transportation to provide information to the 
shipper that identifies the three previous cargoes transported in the 
vehicle, which is consistent with our understanding of current industry 
practice except that the shipper and carrier may agree in writing prior 
to transportation operations that the carrier will provide information 
that identifies fewer than three previous cargoes or that the carrier 
need not provide any such information if procedures have been 
established that would ensure that the bulk vehicle offered will be 
adequate for the intended transportation operation, e.g., if the 
carrier by contract will only offer bulk vehicles dedicated to hauling 
a single type of product. This provision is discussed after the 
description of proposed Sec.  1.908(d)(5). Proposed Sec.  1.908(d)(4) 
would also specify that the written agreement is subject to the records 
requirements of proposed Sec.  1.912(b).
    Proposed Sec.  1.908(d)(5) would require a carrier that offers a 
bulk vehicle for food transportation to provide information to the 
shipper that describes the most recent cleaning of the bulk vehicle, 
except that a shipper and carrier may agree in writing prior to 
transportation operations that the carrier need not provide any such 
information, if procedures have been established 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 prior to loading food 
into the bulk vehicle. Proposed Sec.  1.908(d)(5) would also specify 
that the written agreement is subject to the records requirements of 
proposed Sec.  1.912(b).
    Comments to the 2010 ANPRM stated that in transportation operations 
involving the bulk transport of human and animal food, shippers and 
carriers typically exchange information to ensure that the bulk 
vehicles will, when offered, be suitable for the operation. Shippers in 
some cases may need to know the identity of prior cargoes that were 
hauled in a bulk vehicle to determine whether they were of such a 
nature that they could affect their shipment in any manner that would 
either cause it to become adulterated or that would adversely affect 
its commercial value. Shippers may also need to know how the bulk 
vehicle was cleaned in order to determine that the cleaning procedure 
used was adequate to prepare the bulk vehicle for the transport of 
their product. As noted previously in this section in the discussion of 
proposed Sec.  1.908(b)(1), in the bulk transport of animal feed, it 
may be necessary for the shipper to obtain assurance that specified 
cleanout procedures have been carried out for bulk vehicles that have 
previously hauled medicated feed.
    A circumstance necessitating communication between shippers and 
carriers that might arise in the bulk transport of liquid non-dairy 
foods involves the need to ensure that vehicles that have previously 
hauled milk will not introduce allergens into non-dairy foods through 
cross contact. As noted in the discussion in this section of proposed 
Sec.  1.908(a)(3)(ii), depending upon whether or not a bulk carrier 
uses its vehicles to transport milk, shippers might employ different 
procedures to establish the suitability of a bulk vehicle for the 
transport of their product. For example, if a carrier only provides 
vehicles dedicated to the hauling of a single product, e.g., juice, a 
shipper of juice would not need to know what the previous cargoes of a 
bulk vehicle were before loading its product into the vehicle. If, 
however, the carrier recently hauled milk in a bulk vehicle offered to 
the same shipper, milk residues that might remain in the bulk vehicle 
could contaminate subsequent shipments in the bulk vehicle. The shipper 
may need to know from the carrier that milk was hauled and may also 
need information about the most recent cleaning procedure for the 
tanker.
    In practice, bulk carriers and shippers commonly establish mutually 
acceptable procedures concerning prior cargoes and cleanings, usually 
through contractual arrangements, to ensure that a bulk vehicle will be 
suitable for a transportation operation for which it will be offered. 
Such agreements may be based upon industry guidelines for bulk 
transport that set forth best practices for the hauling of particular 
commodities (Ref. 22) (Ref. 29). These guidelines may call for the use 
of dedicated vehicles for the transport of a particular commodity or 
may identify acceptable prior cargoes when the use of a dedicated 
vehicle is not necessary. These guidelines may also address acceptable 
cleaning procedures for the bulk vehicles.
    While shippers and carriers commonly establish mutually acceptable 
procedures for bulk shipments prior to an actual transportation 
operation, there may be instances where such procedures have not been 
established and a shipper must obtain information from the carrier 
about prior cargoes and cleaning for a bulk vehicle at the time a 
vehicle is offered for his shipment to ensure that the condition of the 
bulk vehicle is adequate to ensure that the food is not adulterated 
during transportation.
    To account for such situations, we tentatively conclude that the 
sanitary food transportation regulations should require that the 
carrier provide information to the shipper that identifies the prior 
cargoes and describes cleaning procedures for a bulk vehicle offered to 
the shipper. We also tentatively conclude that to provide flexibility 
consistent with existing practices, this proposed rule should allow for 
the shipper and carrier to mutually agree in writing to forgo the 
exchange of some or all of this information when it is not necessary to 
ensure that the bulk vehicle is adequate for the intended 
transportation operation.

[[Page 7026]]

    For example, a shipper of juice and a carrier may mutually agree in 
writing that no information need be provided to the shipper about prior 
cargoes in the bulk vehicles if the carrier agrees to only offer bulk 
vehicles that exclusively haul juice. Similarly, if a carrier 
contractually agrees to use a cleaning procedure for bulk vehicles 
deemed suitable by the shipper, these parties could, under proposed 
Sec.  1.908(d)(5), agree in writing that no information need be 
provided to the shipper about the cleaning of the vehicles.
    Under proposed Sec.  1.908(d)(4), the information to be provided by 
a carrier would identify the three previous cargoes hauled in a bulk 
vehicle. We have tentatively concluded that information about the three 
previous cargoes is sufficient to demonstrate to the shipper that the 
condition of the bulk vehicle is adequate to ensure that the food is 
not adulterated during transportation. We have based this tentative 
conclusion, in part, on two industry guidance documents, from a juice 
industry association and a broad food industry association, that 
contain recommendations that shippers obtain information from carriers 
identifying the three previous cargoes of a bulk vehicle (Ref. 22) 
(Ref. 29). We also note that we stated in a 1996 ANPRM published 
jointly with FSIS (61 FR 59372 at 59379) that we were considering 
requiring carriers of potentially hazardous foods (the designation used 
at that time for TCS foods) that are shipped in bulk to provide 
shippers with records that identify the last three cargoes for any 
conveyance being offered to the food shipper for use in transporting 
the food. However, comments to the 2010 ANPRM stated that other sectors 
of the food transportation industry, e.g., the animal feed transport 
sector, typically only exchange information about the immediate 
previous cargo of a bulk vehicle offered. We request comment on whether 
proposed Sec.  1.908(d)(4) and (d)(5) are written with the flexibility 
to enable application across multiple sectors of the bulk human and 
animal food transportation industry and still accomplish its intended 
purpose of providing for information disclosure between carriers and 
shippers as necessary to establish that the condition of the bulk 
vehicle is adequate to ensure that the food is not adulterated during 
transportation. We also request comment on whether there are 
circumstances under which bulk carriers would also need to provide this 
information upon request to receivers about the condition of bulk 
vehicles to ensure that food is not adulterated during transportation.
    We also note that additional requirements relevant to the bulk 
transport of human and animal food may apply to the owner, operator, or 
agent in charge of facilities that manufacture, process, pack, or hold 
food and are subject to the proposed preventive controls rules for 
human and animal food. For example, under the proposed preventive 
controls rule for human food, the owner, operator, or agent in charge 
of such a facility must evaluate known or reasonably foreseeable 
hazards in food, including any that may occur due to transportation 
practices.
    We are requiring in proposed Sec.  1.908(d)(4) and (d)(5) that the 
agreement required by those sections be written to appropriately 
document that a carrier and shipper have agreed to employ an 
alternative procedure available under these provisions.
    Proposed Sec.  1.908(d)(6) would require carriers to develop and 
implement specified written procedures subject to the records 
requirements of proposed Sec.  1.912(b).
    Proposed Sec.  1.908(d)(6)(i) would require that the written 
procedures 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 proposed Sec.  1.906(b).
    The cleaning and inspection of a vehicle or transportation 
equipment is a fundamental element of sanitary food transportation and 
is necessary to ensure that food is not transported under conditions 
that may render it adulterated. As we have noted previously in this 
section in the discussion of proposed Sec.  1.908(b)(1), carriers in 
the food transportation industry commonly use standard procedures to 
appropriately prepare vehicles and transportation equipment for the 
transportation of food. We also noted in that discussion that shippers 
may in some circumstances specify particular procedures to be used by 
carriers in the preparation of vehicles and transportation equipment. 
These types of cleaning procedures could be used in certain 
circumstances by a carrier to meet the proposed requirement for a 
written procedure. The proposed requirement that the procedures be 
written would help ensure that they are consistently applied, 
facilitate training on these procedures, and enable verification by FDA 
and other authorities.
    Proposed Sec.  1.908(d)(6)(ii) would require that the written 
procedures describe how the carrier will comply with the provisions for 
temperature control in proposed Sec.  1.908(d)(2), discussed previously 
in this section. For example, the carrier's written procedures might 
state that the carrier will either provide data from a time/temperature 
recording device to a shipper or (upon request) receiver, or that it 
will provide the shipper with a receipt signed by the receiver noting 
the time of delivery, which in conjunction with the shipment's time of 
the departure (known by the shipper) and the shipper's verification of 
the vehicle's pre-cooling, would be sufficient for the shipper to know 
that the food was transported in accord with the shipment's specified 
temperature conditions. In practice, the carrier might use the first 
procedure for trips of several hours because data from a temperature 
recording device would demonstrate to the shipper or receiver that 
food's temperature was maintained in accord with the shipper's 
specification to the carrier. The carrier might use the second 
procedure for relatively short distance trips where the shipper or 
receiver can be assured that temperature control for the food according 
to his specifications was provided by knowing that the shipment was in 
transit only for a short period of time after departing his facility. 
The determination of the appropriate method would be made by the 
shipper.
    A discussion of the importance of temperature control was 
previously provided in this section in the discussion of proposed Sec.  
1.908(d)(2). The proposed requirement that the procedures be written 
would help ensure that they are consistently applied, facilitate 
training on these procedures, and enable verification by FDA and other 
authorities.
    Proposed Sec.  1.908(d)(6)(iii) would require that the written 
procedures describe how the carrier will comply with the provisions for 
the use of bulk vehicles in proposed Sec.  1.908(d)(4) and (d)(5), 
discussed previously in this section. A discussion of the importance of 
prior cargo information and bulk vehicle cleaning was previously 
provided in this section in the discussion of proposed Sec.  
1.908(d)(4) and (d)(5). The proposed requirement that the procedures be 
written would help ensure that they are consistently applied, 
facilitate training on these procedures, and enable verification by FDA 
and other authorities.

[[Page 7027]]

F. Training (Proposed Sec.  1.910)

    Proposed Sec.  1.910 would establish training requirements for 
carriers. Proposed Sec.  1.910(a) would require that carriers 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 proposed rule. Proposed Sec.  1.910 would also 
require that this training be provided upon hiring and as needed 
thereafter.
    We previously noted that the ERG report identified the lack of 
driver/employee training and/or supervisor/manager/owner knowledge of 
food safety and/or security as a problem area where food may be at risk 
for physical, chemical, or biological contamination during transport 
and storage (Ref. 9). Findings released in 2007 by the Michigan 
Department of Agriculture (Ref. 3) identified low driver awareness of 
safe food temperatures and inadequate food safety training of drivers 
as areas of concern in food transport. Also, as stated in the 
discussions of proposed Sec. Sec.  1.906(c) and 1.908(a)(3)(i) in 
sections III.D and III.E, we continue to receive or otherwise learn of 
reports of foods such as meat and seafood products being transported 
under temperature abuse conditions (Ref. 5) (Ref. 6) (Ref. 7) (Ref. 8), 
and we have received reports in the 3 years since we established the 
Reportable Food Registry of animal feed becoming contaminated during 
transportation due to the insanitary condition of a vehicle (Ref. 2).
    We recognize, based upon comments to the 2010 ANPRM, that food 
transporters commonly implement training programs for their personnel 
that address sanitary food handling. However, we also note that these 
identified areas of concern and recent problems involve practices that 
would be the carrier's responsibility under this proposed rule. This 
would indicate that there is a lack of consistent implementation of 
training in sanitary food handling practices among carriers in the food 
transportation industry. For this reason we are proposing training 
requirements for carriers in this proposed rule. We would envision that 
this training could be provided in half-day online format similar to 
training referred to as DOT HM 181 basic hazmat employee training, 
readily available in the private sector. The proposed training 
provision would require that the training be provided upon hiring and 
as needed thereafter. This would ensure that carrier personnel are 
knowledgeable about food safety issues and their responsibilities 
before they engage in transportation operations. It would also ensure 
that additional training is provided when needed; e.g., when a 
carrier's operations change substantially, or when the employee's 
performance indicates a need for additional training.
    We have tentatively concluded that training needs for shippers and 
receivers would be most appropriately addressed through other 
regulations such as our CGMP regulations and our proposed preventive 
controls rules for human and animal food because these regulations and 
proposed rules contain provisions related to employee training for 
entities that would operate as shippers and carriers.
    Section 110.10(c) of our CGMP regulations for human food provides 
guidance that personnel responsible for identifying sanitation failures 
or food contamination should have a background of education or 
experience, or a combination thereof, to provide a level of competency 
necessary for production of clean and safe food. Section 110.10(c) 
further recommends that food handlers and supervisors receive 
appropriate training in proper food handling techniques and food-
protection principles and should be informed of the danger of poor 
personal hygiene and insanitary practices.
    Our proposed preventive controls rules for human and animal food 
include training requirements for individuals who perform or oversee 
specified functions, e.g., preparation of the food safety plan (78 FR 
3646 at 3761 and 78 FR 64736 at 64750).
    Proposed Sec.  1.910(b) would require that carriers establish and 
maintain records that document required training of personnel. Such 
records would be required to include the date of the training, the type 
of training, and the person(s) trained. These records would be subject 
to the records requirements of proposed Sec.  1.912 (discussed in 
section III.G). Given the importance of adequate training to the 
conduct of sanitary transportation operations by carriers, we 
tentatively conclude that this proposed rule should also require that 
carriers maintain records documenting that they have provided the 
required training to their personnel to enable the agency to verify 
compliance with the training requirement through inspection and records 
examination.

G. Records (Proposed Sec.  1.912)

    Proposed Sec.  1.912 would establish requirements for the retention 
and availability of records applicable to shippers and carriers engaged 
in transportation operations. A discussion of the records we are 
requiring shippers and carriers to maintain and the necessity for the 
maintenance of such records is found in the respective discussions of 
proposed Sec.  1.908(b)(1), (b)(3) and (d)(6) in section III.E.
    Proposed Sec.  1.912(a) would require that shippers retain records 
that demonstrate that they provide information as required by proposed 
Sec.  1.908(b)(1) and (b)(3) as a regular part of their transportation 
operations for a period of 12 months beyond when the shipper is subject 
to any requirement to provide such information.
    Proposed Sec.  1.912(b) would require that carriers retain records 
of any written agreements required by proposed Sec.  1.908(d)(2)(ii) 
and of the written procedures required by proposed Sec.  1.908(d)(6) 
that describe cleaning, sanitizing and inspection procedures for 
vehicles and transportation equipment for a period of 12 months beyond 
when such agreements and procedures are in use in their transportation 
operations. Proposed Sec.  1.912(c) would require that carriers retain 
training records required by proposed Sec.  1.910(b) for a period of 12 
months beyond when the person identified in any such records continues 
to perform the duties for which the training was provided.
    The requirements of proposed Sec.  1.912(a) through (c) would 
enable us to review records of the transportation operations of 
shippers and carriers during inspections for enforcement purposes and 
to assess compliance with the requirements of this proposed rule. In 
the case of records required by proposed Sec.  1.912(a) and (b), we are 
proposing to require a retention period of 12 months to enable us to 
assess the recent operations of a shipper or carrier where it may be 
necessary to do so, e.g., in an investigation of a recent outbreak of 
foodborne illness.
    Proposed Sec.  1.912(d) would require that shippers and carriers 
make all records required by this proposed rule available to a duly 
authorized individual promptly upon oral or written request.
    Proposed Sec.  1.912(e) would require that all records required by 
this proposed rule 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, 
which must be kept in accordance with 21 CFR part 11.
    Proposed Sec.  1.912(f) would provide that except for the written 
procedures

[[Page 7028]]

required by proposed Sec.  1.908(d)(6), offsite storage of records is 
permitted after 6 months following the date that the record was made if 
such records can be retrieved and provided onsite within 24 hours of 
request for official review. Proposed Sec.  1.912(f) would also specify 
that the written procedures required by proposed Sec.  1.908(d)(6) must 
remain onsite as long as the procedures are in use in transportation 
operations.
    Providing for offsite storage of some records after 6 months would 
enable a facility with flexibility to comply with the proposed 
requirements for record retention while reducing the amount of space 
needed for onsite storage of the records without interfering with the 
purpose of record retention, because the records will be readily 
available.
    Proposed Sec.  1.912(f) also would provide that electronic records 
are considered to be onsite if they are accessible from an onsite 
location. Computerized systems within corporations can be networked, 
allowing for the sending and receiving of information in a secure 
fashion to all of the different facilities of that corporation 
worldwide. This type of system can be used to provide access at 
multiple locations to records from multiple plants or facilities.
    Proposed Sec.  1.912(f) is consistent with our Hazard Analysis and 
Critical Control Points (HACCP) regulations for seafood and juice. Our 
HACCP regulation for seafood provides for transfer of records if record 
storage capacity is limited on a processing vessel or at a remote 
processing site, if the records could be immediately returned for 
official review upon request (21 CFR 123.9(b)(3)). Our HACCP regulation 
for juice permits offsite storage of processing records after 6 months 
following the date that the monitoring occurred, if such records can be 
retrieved and provided onsite within 24 hours of request for official 
review and considers electronic records to be onsite if they are 
accessible from an onsite location (21 CFR 120.12(d)(2)).
    Proposed Sec.  1.912(g) would provide that all records required 
this proposed rule are subject to the disclosure requirements under 
part 20 (21 CFR part 20). FDA's regulations in part 20, the Freedom of 
Information Act (FOIA) (5 U.S.C. 552), the Trade Secrets Act (18 U.S.C. 
1905), and the FD&C Act, govern FDA's disclosures of information, 
including treatment of commercial confidential information (CCI) and 
trade secret information.

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

1. Statutory Authority
    Section 416(d) of the FD&C Act provides the Secretary with the 
authority to waive any requirement under section 416 of the FD&C Act, 
which would include the requirements of this proposed rule, with 
respect to any class of persons, vehicles, food, or nonfood products, 
if the Secretary determines that the waiver will not result in the 
transportation of food under conditions that would be unsafe for human 
and animal health and will not be contrary to the public interest. 
Section 416(d)(2) of the FD&C Act further provides that the Secretary 
shall publish in the Federal Register any waiver and the reasons for 
the waiver. Aside from section 416(d)(2), section 416 does not 
expressly prescribe the procedures for granting a waiver under section 
416(d) or for revoking or amending a waiver that has already been 
granted under section 416(d).
2. Proposed Requirements
    Consistent with the statutory provisions mentioned previously, we 
are proposing a process by which FDA will grant waivers from one or 
more requirements of subpart O on its own initiative or in response to 
a petition from an interested person, including information that must 
accompany such petitions, and the procedures and circumstances under 
which FDA may grant or deny such petitions, and modify or revoke any 
waivers that have already been granted. Waivers granted by FDA would be 
limited to the requirements of subpart O specified by FDA in the 
Federal Register notice announcing the waiver, and would have no effect 
on the application of other provisions of the FD&C Act or FDA 
regulations.
    Proposed Sec.  1.914 would provide that FDA may waive a requirement 
of subpart O with respect to any class of persons, vehicles, food, or 
nonfood products, if FDA determines that the waiver will not result in 
the transportation of food under conditions that would be unsafe for 
human or animal health and the waiver will not be contrary to the 
public interest. This proposed provision is identical to the standard 
set forth in section 416(d)(1) of the FD&C Act. Under this standard, a 
waiver could be granted with regard to a specific requirement or subset 
of requirements of subpart O or with regard to all requirements set 
forth in subpart O. Similarly, under this standard, a waiver could be 
granted with regard to any class of persons, vehicles, food, and/or 
nonfood products and the transportation operations in which they 
engage.
    Proposed Sec.  1.916 would provide that FDA will consider whether 
to waive a requirement of subpart O on FDA's own initiative or on the 
petition submitted under Sec.  10.30 (21 CFR 10.30) by any person who 
is subject to the requirements of subpart O with respect to any class 
of persons, vehicles, food, or nonfood products. FDA would welcome 
requests for pre-petition consultations, including meetings, with 
interested persons to facilitate the development of petitions seeking a 
waiver of some or all of the requirements of subpart O, including data 
and information necessary to demonstrate that the waiver will not 
result in the transportation of food under conditions that would be 
unsafe for human or animal health and that the waiver will not be 
contrary to the public interest.
    Proposed Sec.  1.918 would provide that, in addition to the 
requirements set forth in Sec.  10.30, the Statement of Grounds (which 
is addressed under Sec.  10.30(b)) of a petition requesting a waiver 
must 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 subpart O to which the waiver 
would apply (proposed Sec.  1.918(a)). In addition, the Statement of 
Grounds would also be required to 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 (proposed Sec.  1.918(b)). Under 
these provisions, an interested person would be required to submit 
relevant and scientifically-valid information or materials specific to 
the requested waiver to demonstrate 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. 
This could include information about the nature of the food, the manner 
in which it is transported, the controls in place to mitigate any food 
safety issues, and government and/or non-government oversight of the 
transportation of the food.
    Proposed Sec.  1.920 establishes our presumption 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. We do not believe that

[[Page 7029]]

information exempt from disclosure under part 20 of this chapter is the 
type of information that FDA is requiring to be submitted in such a 
petition or that would be relevant in any comments submitted on such a 
petition. We also believe that providing full public access to this 
information is important to ensuring transparency and for the 
opportunity for other interested parties to offer comment on the 
petition. Therefore, we expect to make these submissions publicly 
available.
    Proposed Sec.  1.922 would establish 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 of the 
Office of Compliance, CFSAN, or the Director of the Office of 
Surveillance and Compliance, CVM, as the responsible official for 
responding to a request for a waiver from one or more requirements in 
subpart O.
    Proposed Sec.  1.924 would establish the general procedures 
applying to a petition requesting a waiver from one or more 
requirements in subpart O. Proposed Sec.  1.924(a) would provide that 
the procedures sets forth in Sec.  10.30 govern the process by which 
FDA responds to a petition requesting a waiver. Section 10.30 specifies 
the requirements for any citizen petition submitted by a person 
(including a petitioner who is not a citizen of the United States) to 
FDA. Proposed Sec.  1.924(b) would establish that, under Sec.  
10.30(h)(3), we will publish a notice in the Federal Register, 
requesting information and views on the filed petition, including 
information and views from persons who could be affected by the waiver 
if the petition were to be granted (e.g., because the waiver would also 
apply to certain or all transportation operations performed by a 
person). Such persons could include those whose transportation 
operations are conducted under similar circumstances with similar 
procedures, processes, or practices as those addressed in the petition, 
or could include shippers, carriers, or receivers who are engaged in 
transportation operations of food that is similar or identical to a 
specific food addressed in the petition.
    Proposed Sec.  1.924(c) would establish that, under Sec.  
10.30(e)(3), FDA will respond to the petitioner in writing. Proposed 
Sec.  1.924(c)(1) would establish that, 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. This 
action is required by section 416(d)(2) of the FD&C Act. Proposed Sec.  
1.924(c)(2) would establish that, if FDA denies the petition (including 
partial denials), FDA will explain the reason(s) for the denial in its 
written response to the petitioner. Under proposed Sec.  1.924(d), we 
propose to 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). The 
provisions in proposed Sec.  1.924 would ensure transparency in FDA's 
activities and decision-making, which allows the public to better 
understand the agency's decisions, increasing credibility and promoting 
accountability.
    Proposed Sec.  1.926 would provide that we may deny a petition 
requesting a waiver if it does not provide the information required 
under proposed Sec.  1.918 (including the requirements of Sec.  10.30), 
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. For 
example, we would expect to deny a petition if the petitioner failed to 
submit data, information, or other materials to demonstrate that the 
requested waiver would not result in the transportation of food under 
conditions that would be unsafe for human or animal health.
    Proposed Sec.  1.928 would provide that if FDA, on its own 
initiative, determines that a waiver is appropriate, FDA will publish a 
notice in the Federal Register setting forth the waiver and the reasons 
for such waiver. Under certain circumstances, FDA may solicit public 
comment on a proposed waiver before making a final determination 
regarding whether to grant a waiver (as we have in this proposed rule, 
as discussed later in this section). However, under other 
circumstances, when FDA has 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, FDA may grant a waiver without first 
soliciting public comment. We have tentatively concluded that this 
process is sufficient for FDA granting a waiver on its own initiative 
because it is the process set forth in section 416(d)(2) of the FD&C 
Act.
    Proposed Sec.  1.930 would specify that a waiver granted by FDA 
becomes effective on the date that notice of the waiver is published in 
the Federal Register.
    Under proposed Sec.  1.932, we would be able to 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. For example, we may deem it necessary to modify terms and 
conditions of a waiver based on a review of updated scientific data or 
factual information related to the procedures, processes, or practices 
utilized by the transportation operations that are covered by the 
waiver.
    Proposed Sec.  1.934 would establish the procedures that apply if 
FDA determines that a waiver should be modified or revoked. Under 
proposed Sec.  1.934(a), we would provide notice of such a 
determination as follows: (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 a 
petition should be modified or revoked; and (2) we will publish in the 
Federal Register a notice of our determination that a waiver should be 
modified or revoked. This notice will establish a public docket so that 
interested parties may submit written submissions on our determination. 
FDA requests comments on whether it should establish requirements for 
the timely submissions to the public docket, and if so, whether it 
should do so in the final rule or whether it would be more appropriate 
to address this issue in a guidance document.
    Under proposed Sec.  1.934(b), we would consider written 
submissions submitted to the public docket from interested parties.
    Under proposed Sec.  1.934(c), we would publish a notice of our 
final decision in the Federal Register. The effective date of the 
decision will be the date of publication of the notice.
    We tentatively conclude that these provisions are necessary and 
appropriate not only to ensure transparency and accountability in FDA's 
activities and decisionmaking, but also to provide relevant parties 
with an opportunity for due process.
3. Potential Waivers
    Under the standard set forth in section 416(d)(1) and proposed 
Sec.  1.914, and as discussed further in the paragraphs that follow, we 
have tentatively determined that it would be appropriate to waive the 
applicable requirements of subpart O, 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

[[Page 7030]]

transportation operations involving Grade A milk and milk products.
     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.
    We intend 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 classes of persons from the applicable requirements 
of subpart O. We request comment regarding whether these 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.
    a. Shippers, carriers, and receivers holding valid permits under 
the NCIMS Grade ``A'' Milk Safety Program, only when engaged in 
transportation operations involving Grade A milk and milk products. The 
NCIMS Grade ``A'' Milk Safety Program, participated in by all 50 
States, the District of Columbia, and Puerto Rico, uses as its basic 
standard a model milk regulation, the Grade ``A'' Pasteurized Milk 
Ordinance (Grade ``A'' PMO) (Ref. 30) which incorporates provisions 
governing the production, storage, handling, processing, packaging, 
transportation, and sale of Grade ``A'' milk and milk products, 
including buttermilk and buttermilk products, whey and whey products, 
and condensed and dry milk products. Provisions of the Grade ``A'' PMO 
and the Grade ``A'' Milk Safety Program address milk tank trucks and 
operations involving them, including farm bulk milk pick-up tankers and 
milk transportation tanks used to transport Grade ``A'' milk and milk 
products in interstate commerce.
    The Grade ``A'' PMO, and the state regulations modeled after the 
PMO, specifies that every milk producer, milk distributor, bulk milk 
hauler/sampler, milk tank truck, milk transportation company, and each 
milk plant, receiving station, transfer station, and milk tank truck 
cleaning facility operator shall hold a valid permit issued by an 
authorized regulatory agency, i.e., a State government agency. 
Furthermore, when any requirement of the Grade ``A'' milk safety 
program is violated, the permit holder is subject to the suspension of 
their permit. The Grade ``A'' PMO also specifies that each dairy farm, 
milk plant, receiving station, transfer station, and milk tank truck 
cleaning facility whose milk or milk products are intended for 
consumption within a state's jurisdiction, and each bulk milk hauler/
sampler who collects samples of raw milk for pasteurization, for 
bacterial, chemical or temperature standards and hauls milk from a 
dairy farm to a milk plant, receiving station or transfer station and 
each milk tank truck and its appurtenances, shall be inspected/audited 
by the regulatory agency prior to the issuance of a permit and at 
specified intervals following the issuance of a permit.
    We have tentatively determined that waiving the requirements of 
subpart O, if finalized as proposed, with respect to shippers, 
carriers, and receivers who hold valid permits and are inspected under 
the NCIMS Grade ``A'' Milk Safety Program, only when engaged in 
transportation operations involving Grade A milk and milk products, 
would not result in the transportation of food under conditions that 
would be unsafe for human or animal health and would not be contrary to 
the public interest. Specifically, we have determined that shippers, 
carriers, and receivers who hold permits and are inspected under the 
NCIMS Grade ``A'' Milk Safety Program, by complying with requirements 
that are identical to those set forth in the Grade ``A'' PMO, are using 
sanitary transportation practices to ensure that Grade A milk and milk 
products are not transported under conditions that may render such 
products adulterated. For example, under such requirements, trucks that 
transport milk from one milk plant to another must be sealed and 
temperatures of all milk and milk products must be verified for every 
tank truck load of milk or milk product received at these facilities. 
Further, all tank truck loads of milk or milk product that are shipped 
from Grade A facilities must include a shipping statement that 
includes, among other things, the seal numbers from the seals that were 
applied at the shipping plant and the temperature of the product upon 
loading. Based on our of analysis these, and other similar 
requirements, and the inspection and permitting processes that 
currently exist within the NCIMS Grade ``A'' Milk Safety Program, we 
have tentatively determined that the requirements of proposed subpart 
O, if finalized as proposed, would not be necessary to ensure that 
Grade A milk and milk products are not transported under conditions 
that may render such products adulterated. Accordingly, we are 
proposing to waive the requirements of subpart O, if finalized as 
proposed, with respect to shippers, carriers, and receivers who hold 
valid permits and are inspected under the NCIMS Grade ``A'' Milk Safety 
Program, only when engaged in transportation operations involving Grade 
A milk and milk products.
    b. Food Establishments holding valid permits, only when engaged in 
transportation operations as receivers, or as shippers or carriers in 
operations in which food is relinquished to consumers after 
transportation from the establishment. For the purpose of establishing 
the scope of this potential waiver, we intend to define ``Food 
Establishment,'' using the definition set forth in the current edition 
of the Food Code (Ref. 17):
    Food establishment means an operation that:
     Stores, prepares, packages, serves, vends food directly to 
the consumer, or otherwise provides food for human consumption such as 
a restaurant; satellite or catered feeding location; catering operation 
if the operation provides food directly to a consumer or to a 
conveyance used to transport people; market; vending location; 
conveyance used to transport people; institution; or food bank; and
     Relinquishes possession of food to a consumer directly or 
indirectly through a delivery service such as home delivery of grocery 
orders or restaurant takeout orders, or delivery service that is 
provided by common carriers.
    The Food Code specifies that a person who operates a food 
establishment should hold a valid permit issued by the regulatory 
authority, i.e., a State government agency (Ref. 31). Only a food 
establishment operator who holds such a permit would fall within the 
scope of this potential waiver.
    Food establishments, with the exception of establishments subject 
to the requirements of 21 CFR parts 1240 and 1250 that provide food to 
conveyances used to transport people, are generally subject to 
regulatory oversight, including permitting, by the more than 3,000 
State, local, and tribal agencies that have primary responsibility to 
regulate the retail food and foodservice industries in the United 
States. These agencies are primarily responsible for the inspection and 
oversight of over 1 million food establishments that provide food 
directly to consumers. FDA assists these agencies and the industries 
they regulate by promoting the application of science-based food safety 
principles in retail and foodservice settings to minimize the incidence 
of foodborne illness. FDA publishes the Food Code to assist food 
control jurisdictions at all levels of government by providing them 
with a scientifically sound technical and legal model for regulating 
the retail and food service segment of the industry

[[Page 7031]]

(restaurants and grocery stores and institutions such as nursing 
homes). Local, State, tribal, and Federal regulators use the Food Code 
as a model to develop or update their own food safety rules and to be 
consistent with national food regulatory policy. State codes patterned 
after the current or previous versions of the Food Code have been 
adopted in all 50 States. FDA also assists these regulators by 
providing scientifically-based guidance, training, program evaluation, 
and technical assistance.
    FDA principally addresses aspects of sanitary food transportation 
relevant to retail food and food service operations through the 
provisions of the Food Code that address inspection and handling of 
food upon receipt to ensure that it does not appear to have been 
subject to contamination or temperature abuse. For example, since 1993 
the Food Code has contained provisions addressing the temperature of 
TCS foods at the time they are received by a food establishment that 
would ensure that these foods are not received after transportation at 
temperatures at which the food could become unsafe (Ref. 32). In 
addition, provisions of the Food Code that address preventing food 
contamination and food holding temperatures for TCS foods or the use of 
time as a public health control, in the absence of temperature control, 
would apply to the transportation of foods from a food establishment to 
a site where the food would be relinquished to a consumer (Ref. 32).
    We regard the regulatory programs of State and local agencies 
patterned upon the Food Code to be substantive, comprehensive, and 
effective in addressing food safety issues associated with retail food 
and food service operations and we intend to continue to operate 
through the Federal/State cooperative mechanism.
    We have tentatively determined that waiving the requirements of 
subpart O, if finalized as proposed, with respect to food 
establishments holding valid permits, only when engaged in 
transportation operations as receivers, or as shippers and carriers for 
operations in which food is relinquished to consumers after 
transportation from the establishment, would not result in the 
transportation of food under conditions that would be unsafe for human 
or animal health and would not be contrary to the public interest. 
Specifically, we have determined that such food establishments, by 
complying with state requirements that are modeled after the Food Code, 
are using sanitary transportation practices to ensure that food is not 
transported under conditions that may render such products adulterated. 
We note that we are proposing this waiver only with respect to such 
food establishments when engaged in transportation operations as 
receivers and as shippers or carriers for operations in which food is 
relinquished to consumers after transportation from the establishment. 
If food establishments perform other functions that cause them to meet 
the definition of shipper and/or carrier under proposed Sec.  1.904, 
e.g., transport food from a distribution facility to their 
establishment, any requirements under proposed subpart O that would 
apply to such entities as shippers and/or carriers would still be 
applicable and would not be waived.
    As previously discussed in this section, we are proposing in Sec.  
1.934 to establish a procedure whereby FDA may revoke waivers with 
appropriate notice and comment.

IV. Preliminary Regulatory Impact Analysis

A. Overview

    FDA has examined the impacts of this proposed 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 Agencies 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, and other advantages; distributive impacts; and 
equity). We have developed a Preliminary Regulatory Impact Analysis 
(PRIA) that presents the benefits and costs of this proposed rule (Ref. 
33). We believe that the proposed rule will be a significant regulatory 
action as defined by Executive Order 12866. We request comments on the 
PRIA.
    The summary analysis of benefits and costs included in this 
document is drawn from the detailed PRIA (Ref. 33) which is available 
at https://www.regulations.gov (Docket No. FDA-2013-N-0013) and is also 
available on FDA's Web site at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. This proposed rule does not cover any shipper, 
receiver or carrier with annual revenues of less than $500,000. 
Nevertheless, the Agency tentatively concludes that the final rule 
could have a significant economic impact on a substantial number of 
small entities covered by this proposed rule which would meet our 
proposed definition of a ``small business.''

C. Unfunded Mandates Reform Act of 1995

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``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 $141 million, using the most current (2012) Implicit 
Price Deflator for the Gross Domestic Product. FDA expects that this 
proposed rule will result in a 1-year expenditure that would meet or 
exceed this amount.
    The analyses that we have performed to examine the impacts of this 
proposed rule under Executive Order 12866, Executive Order 13563, the 
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of 
1995 are available to the public in the docket for this proposed rule 
(Ref. 33).

V. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information have been submitted to OMB for review under 
section 3507(d) of the Paperwork Reduction Act of 1995. FDA invites 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

[[Page 7032]]

    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, 
or emailed to oira_submission@omb.eop.gov. All comments should be 
identified with the title ``Sanitary Transportation of Human and Animal 
Food.''
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), the Agency has submitted the information collection 
provisions of this proposed rule to OMB for review. These requirements 
will not be effective until FDA obtains OMB approval. FDA will publish 
a notice concerning OMB approval of these requirements in the Federal 
Register.
    The analysis that FDA has performed in order to examine the impact 
of this proposed rule under the Paperwork Reduction Act of 1995, with 
estimates of the annual reporting, recordkeeping, and third-party 
disclosure burden, is available to the public in the docket for this 
proposed rule (Ref. 33).

VI. Analysis of Environmental Impact

    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. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive Order requires agencies to ``construe . . . a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Federal law 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 of the FD&C Act, or with a regulation issued 
under section 416 of the FD&C Act, 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 
of the FD&C Act or a regulation issued under section 416 of the FD&C 
Act. Section 416(e) further provides that the express preemption 
provision applies to transportation that occurs on or after the 
effective date of regulations issued under section 416 of the FD&C Act. 
This express preemption provision would apply to the requirements of 
this proposed rule, when finalized.

VIII. Proposed Effective and Compliance Dates

    While the current practices of many businesses are sufficient to 
satisfy some of the proposed requirements, some businesses will need to 
make at least some changes if the proposed rule is finalized. FDA 
tentatively concludes that it is appropriate to provide a sufficient 
time period following publication of the final regulation for entities 
to come into compliance. We proposed that any final rule under the 2005 
SFTA become effective 60 days after publication in the Federal 
Register, with staggered compliance dates. FDA believes that it is 
reasonable to allow for 1 year after the date of publication of the 
final rule for businesses other than small businesses to come into 
compliance with the new requirements. FDA also believes that it is 
reasonable to allow for 2 years after the date of publication of the 
final rule for small businesses to come into compliance with the new 
requirements. FDA intends to work closely with the food transportation 
industry, extension and education organizations, and State partners to 
facilitate implementation of this rule. We request comment on our 
proposed approach to compliance dates.

IX. Request for Comments

    We invite public comment on the matters specified in this document 
as well as any other matters concerning the proposed sanitary 
transportation of human and animal food regulations that are of 
interest. Interested persons may submit either electronic comments 
regarding this document to https://www.regulations.gov or written 
comments to the Division of Dockets Management (see ADDRESSES). It is 
only necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

X. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at https://www.regulations.gov. (We 
have verified the Web site addresses, but we are not responsible for 
any subsequent changes to the Web sites after this document publishes 
in the Federal Register.)

1. Hennessy T.W., Hedberg, C.W., Slutsker, L. et al., 1996, ``A 
National Outbreak of Salmonella Enteriditis Infections From Ice 
Cream,'' New England Journal of Medicine, Vol. 334, No. 20, pp. 
1281-1286, available at https://www.nejm.org/doi/full/10.1056/NEJM199605163342001#t=articleTop, accessed and printed on September 
10, 2013.
2. FDA Memorandum, ``Feed RFRs Related to Transportation Problems,'' 
2012.
3. Wojtala, G., 2007, 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 September 9, 2013.
4. Michigan Department of Agriculture, ``Food Truck Assessment 
Project, April 18/19, 2006.''
5. The Indy Channel, ``200 Pounds of Contaminated Food Headed to 
Central Indiana Restaurants in Semi Destroyed, Police: Raw Chicken, 
Veggies Found Together,'' (https://www.theindychannel.com/news/local-news/200-pounds-of-contaminated-food-headed-to-central-indiana-restaurants-in-semi-destroyed), 2013, accessed and printed on 
September 9, 2013.
6. Caledonia Record, ``DMV Stops Truck, Finds Spoiled Food,'' August 
18, 2012.
7. Courier Journal, ``Overheated Transport Trucks Spark Concerns 
About Spoilage,'' August 10, 2012.
8. Motor Carrier Division, Michigan State Police, ``Commercial Motor 
Vehicle Enforcement Quarterly,'' (https://www.michigan.gov/documents/msp/CMV_Quarterly_January_2007_205099_7.pdf), 2007, accessed 
and printed on September 9, 2013.
9. Eastern Research Group, Inc., 2009, Characteristics of Current 
Food Transportation and Holding Practices for Food Commodities, GSA 
MOBIS SIN 874-1, Contract No. GS-10F-0125P, Order 
No.HHSF223200730236G, ERG Task No. 0193.16.001.001)
10. FDA, ``Guidance for Industry: Sanitary Transportation of Food,'' 
(https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/sanitationtransportation/ucm208199.htm), accessed and printed on January 28, 2014.
11. FSIS, ``FSIS Safety and Security Guidelines for the 
Transportation and Distribution of Meat, Poultry, and Egg 
Products,'' (https://www.fsis.usda.gov/shared/PDF/Transportation_Security_Guidelines.pdf), 2005, accessed and printed on September 
9, 2013.

[[Page 7033]]

12. FDA, ``Compliance Policy Guide Sec. 565.100 FDA Jurisdiction 
Over Meat and Poultry Products,'' 2005.
13. FSIS, ``HACCP for Shelf Stable Processes,'' (https://www.fsis.usda.gov/shared/PDF/FSRE_SS_HACCP_Student.pdf), 2009, 
accessed and printed on September 9, 2013.
14. Greater Pittsburgh Community Food Bank, ``Shelf Life of Food 
Bank Products,'' (https://www.pittsburghfoodbank.org/pdf/shelflifeguide.pdf), 2012, accessed and printed on September 9, 
2013.
15. NSW Food Authority, ``Shelf Stable Acid Preserved Foods,'' 
(https://www.foodauthority.nsw.gov.au/_Documents/science/shelf-stable-acid-preserved-foods.pdf), 2011, accessed and printed on 
September 10, 2013.
16. FSIS, ``Shelf Stable Food Safety,'' (https://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safety-fact-sheets/safe-food-handling/shelf-stable-food-safety), 
2013, accessed and printed on September 9, 2013.
17. FDA, ``Food Code 2009: Chapter 1--Purpose and Definitions,'' 
2009.
18. Compressed Gas Association, letter, ``Docket No. FDA-2010-N-
0013,'' 2010.
19. Airgas, Inc., letter, ``Docket No. FDA-2010-N-0013,'' 2010.
20. North American Produce Transportation Working Group, ``Produce 
Transportation Best Practices,'' (https://www.hortcouncil.ca/uploads/file/naptwg_produce_trans_best_practices.pdf), 2012, accessed 
and printed on September 9, 2013.
21. University of Florida IFAS Extension, ``Sanitary Design and 
Construction of Food Equipment,'' (https://edis.ifas.ufl.edu/fs119), 
2011, accessed and printed on September 9, 2013.
22. Juice Products Association, ``Model Tanker Wash Guidelines for 
the Fruit Juice Industry,'' (https://www.tankerwash.org/data/archive/JPA%20Model%20Tanker%20Wash%20Guidelines%20November%202010(1).pdf), 
2010, accessed and printed on September 9, 2013.
23. FSIS, ``Kitchen Companion: Your Safe Food Handbook,'' (https://www.fsis.usda.gov/wps/wcm/connect/2bc7ada9-12a4-4b36-960c-3230904edcc2/Kitchen_Companion.pdf?MOD=AJPERES&;CACHEID=8bf06fa4-b0e7-488a-afff-
22018c3bb075), 2008, accessed and printed on September 9, 2013.
24. FDA, ``Food Code 2009: Annex 3--Public Health Reasons/
Administrative Guidelines--Chapter 3, Food,'' 2009.
25. FDA, ``Food Code 2009: Annex 3--Public Health Reasons/
Administrative Guidelines--Chapter 1, Purpose and Definitions,'' 
2009.
26. Institute of Food Technologists, ``Evaluation and Definition of 
Potentially Hazardous Foods--Chapter 2,'' (https://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/ucm094143.htm), 
2001, accessed and printed on September 9, 2013.
27. Cornell University College of Agriculture and Life Sciences, 
``Paenibacillus and Bacillus Are the Shelf-Life Limiting Microbes 
for Fluid Milk Products,'' (https://impact.cals.cornell.edu/project/paenibacillus-and-bacillus-are-shelf-life-limiting-microbes-fluid-milk-products), accessed and printed on September 9, 2013.
28. University of Guelph, ``Microorganisms in Milk,'' (https://www.uoguelph.ca/foodscience/dairy-science-and-technology/dairy-microbiology/microorganisms-milk), 2010, accessed and printed on 
September 9, 2013.
29. National Food Processors Association, letter, ``Safeguarding 
Food From Contamination During Transportation,'' 1991.
30. FDA, ``Grade 'A' Pasteurized Milk Ordinance (2011 Revision),'' 
2012.
31. FDA, ``Food Code 2009: Chapter 8--Compliance and Enforcement,'' 
2009.
32. FDA, ``Food Code 2009: Chapter 3--Food,'' 2009.
33. FDA, ``Preliminary Regulatory Impact Analysis,'' 2014.

List of Subjects in 21 CFR Part 1

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

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 1 be 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. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 
U.S.C. 321, 331, 333, 334, 335a, 343, 350c, 350d, 350e, 352, 355, 
360b, 362, 371, 374, 381, 382, 387, 387a, 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 and carriers engaged in transportation operations?

Waivers

1.914 Under what circumstances will FDA waive a requirement of this 
subpart?
1.916 When will FDA 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 are 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 FDA deny a petition requesting a 
waiver?
1.928 What process will FDA follow when waiving a requirement of 
this subpart on FDA's own initiative?
1.930 When will a waiver granted by FDA become effective?
1.932 Under what circumstances may FDA modify or revoke a waiver?
1.934 What procedures apply if FDA determines 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, 
the requirements of this subpart apply to shippers, receivers, 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, 110, 118, 225, and 589).
    (b) The requirements of this subpart do not apply to shippers, 
receivers, or carriers when they are engaged in transportation 
operations of:
    (1) Food that is transshipped through the United States to another 
country; or
    (2) Food that is imported for future export and that is neither 
consumed nor distributed in the United States.


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

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of section 402(i) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 342(i)) in that the food has been transported or offered for 
transport by a shipper, carrier by motor vehicle or rail vehicle, 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, 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 (21 U.S.C. 
331(hh)).


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 (21 U.S.C. 321) 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 owns, leases, or is otherwise ultimately 
responsible for the use of a motor vehicle or rail vehicle to transport 
food. 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. 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.
    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 means a facility in one general physical location devoted to 
the growing and harvesting of crops, the raising of animals (including 
seafood), or both. The term ``farm'' includes 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.
    Food means food as defined in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act and includes raw materials and ingredients. Food 
includes animal food and food also subject to the Federal Meat 
Inspection Act, the Poultry Products Inspection Act, and the Egg 
Products Inspection Act.
    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.
    Microorganisms means yeasts, molds, bacteria, viruses, protozoa, 
and microscopic parasites and includes species having public health 
significance. The term ``undesirable microorganisms'' includes 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.
    Non-covered business means a shipper, receiver, or carrier engaged 
in transportation operations that has less than $500,000 in total 
annual sales.
    Pest means any objectionable animals or insects including birds, 
rodents, flies, and larvae.
    Receiver means any person who receives food after transportation, 
whether or not that person represents the final point of receipt for 
the food. A receiver may also be a carrier or a shipper if the person 
also performs those functions as defined in this subpart. A receiver 
does not include an individual consumer or a person who receives or 
holds food on behalf of an individual consumer and who is not also a 
party to the transaction and who is not in the business of distributing 
food.
    Shelf stable food means 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 juice, canned vegetables, 
canned meat, bottled water and dry food items such as rice, pasta, 
flour, sugar, and spices.
    Shipper means a person who initiates a shipment of food by motor 
vehicle or rail vehicle. The shipper is 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. A shipper may 
also be a carrier or a receiver if the shipper also performs those 
functions as defined in this subpart.
    Small business means a business subject to Sec.  1.900(a) employing 
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) having less than $25,500,000 in annual 
receipts.
    Time/temperature control for safety (TCS) Food means a food that 
requires time/temperature control for safety to limit pathogenic 
microorganism growth or toxin formation.
    Transportation means any movement of food in commerce by motor 
vehicle or rail vehicle.
    Transportation equipment means equipment used in food 
transportation operations, other than vehicles, 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 solely of 
shelf stable food that is completely enclosed by a container, 
compressed food gases or live food animals. In addition, transportation 
operations do not include any transportation activities for raw 
agricultural commodities 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 filthy, putrid, 
decomposed or otherwise unfit for food, or being rendered injurious to 
health from any source during transportation operations.

[[Page 7035]]

    (b) Vehicles and transportation equipment must 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.
    (c) 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.
    (d) Each freezer and mechanically refrigerated cold storage 
compartment in vehicles or transportation 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 installed 
to show the temperature accurately within the compartment.
    (e) 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.

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, and receivers engaged in transportation operations.
    (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 
filthy, putrid, decomposed or otherwise unfit for food, or being 
rendered injurious to health from any source during transportation 
operations, including:
    (i) Taking effective measures such as segregation or isolation to 
protect food from contamination by raw foods and non-food 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) For food that can support the rapid growth of undesirable 
microorganisms in the absence of temperature control during 
transportation, ensuring that the food is transported in a manner, 
including the temperature conditions, such that the transportation 
operation meets the requirements of paragraph (a)(3) of this section.
    (b) Requirements applicable to shippers engaged in transportation 
operations. (1) 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).
    (2) Before loading food not completely enclosed by a container onto 
a vehicle provided by a carrier or into transportation equipment 
provided by a carrier, the shipper must visually inspect the vehicle or 
the transportation equipment provided by the carrier for cleanliness. 
The shipper must determine that the vehicle or transportation equipment 
is in appropriate sanitary condition for the transport of the food, 
e.g., it is free of visible evidence of pest infestation and of debris, 
previous cargo, or dirt that could cause the food to become 
adulterated.
    (3) A shipper of 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, must specify in 
writing to the carrier, except a carrier who transports the food in a 
thermally insulated tank, the temperature conditions necessary during 
the transportation operation, including the pre-cooling phase, to 
ensure that the operation will maintain the temperature conditions and 
meet the requirements of paragraph (a)(3) of this section. The 
information submitted by the shipper to the carrier is subject to the 
records requirements in Sec.  1.912(a).
    (4) Before loading food, a shipper of food that can support the 
rapid growth of undesirable microorganisms in the absence of 
temperature control during transportation, must verify that each 
freezer and mechanically refrigerated cold storage compartment or 
container has been pre-cooled in accordance with information submitted 
by the shipper as required by paragraph (b)(3) of this section.
    (5) 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).
    (c) Requirements applicable to shippers and receivers engaged in 
transportation operations. (1) Shippers and receivers must provide 
vehicle operators who are expected to handle food not completely 
enclosed by a container during loading and unloading operations with 
access to a hand washing facility. The hand washing facility must be 
convenient and provide running water to enable vehicle operators to 
wash their hands and avoid contamination of food.
    (2) Shippers and receivers of food that can support the rapid 
growth of undesirable microorganisms in the absence of temperature 
control during transportation must carry out loading and unloading 
operations under conditions that will prevent the food from supporting 
such microbial growth.
    (d) Requirements applicable to carriers engaged in transportation 
operations. (1) A carrier must supply a vehicle and transportation 
equipment that meets any requirements specified by the shipper in 
accordance with paragraph (b)(1) of this section 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.
    (2) A carrier:
    (i) Must, once the transportation operation is complete, 
demonstrate to the shipper and if requested, to the receiver, that it 
has maintained

[[Page 7036]]

temperature conditions during the transportation operation consistent 
with those specified by the shipper in accordance with Sec.  
1.908(b)(3). Such demonstration 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.
    (ii) Is not subject to the requirement of paragraph (d)(2)(i) of 
this section if the carrier and shipper agree in writing, before 
transportation operations, that the shipper is 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. The carrier 
must provide the written agreement to the receiver, if requested. The 
written agreement is subject to the records requirements of Sec.  
1.912(b).
    (3) 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 pre-cool each 
mechanically refrigerated freezer and cold storage compartment as 
specified by the shipper in accordance with paragraph (b)(3) of this 
section.
    (4) 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. The shipper and carrier 
may agree in writing that the carrier will provide information that 
identifies fewer than three previous cargoes or that the carrier need 
not provide any such information if procedures have been established 
that would ensure that the bulk vehicle offered will be adequate for 
the intended transportation operation, e.g., if the carrier by 
contract, will only offer vehicles dedicated to hauling a single type 
of product. The written agreement is subject to the records 
requirements of Sec.  1.912(b).
    (5) 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, 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. The written agreement 
is subject to the records requirements of Sec.  1.912(b).
    (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);
    (ii) Describe how it will comply with the provisions for 
temperature control in paragraph (2) of this section, and;
    (iii) Describe how it will comply with the provisions for the use 
of bulk vehicles in paragraphs (d)(4) and (d)(5) of this section.

Training


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

    (a) 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 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 and carriers engaged in transportation operations?

    (a) Shippers must retain records that demonstrate that they provide 
information to carriers as required by Sec.  1.908(b)(1) and (3) as a 
regular part of their transportation operations for a period of 12 
months beyond when the shipper is subject to any requirement to provide 
such information.
    (b) Carriers must retain any written agreements required by Sec.  
1.908(d)(2)(ii) of this subpart and records of the written procedures 
required by Sec.  1.908(d)(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 continues to perform the duties for which the training 
was provided.
    (d) Shippers and carriers must make all records required by this 
subpart available to a duly authorized individual promptly upon oral or 
written request.
    (e) 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, which must be kept in accordance with 
part 11 of this chapter.
    (f) Except for the written procedures required by Sec.  
1.908(d)(6), offsite storage of records is permitted after 6 months 
following the date that the record was made 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(d)(6) 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.
    (g) 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 FDA waive a requirement of 
this subpart?

    FDA will waive any requirement of this subpart with respect to any 
class of persons, vehicles, food, or nonfood products, when FDA 
determines 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 FDA consider whether to waive a requirement of 
this subpart?

    FDA will consider whether to waive a requirement of this subpart on 
FDA's 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:

[[Page 7037]]

    (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 are 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.
    (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 FDA 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 FDA follow when waiving a requirement of 
this subpart on FDA's own initiative?

    If FDA, on its own initiative, determines that a waiver is 
appropriate, FDA 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 granted by FDA become effective?

    Any waiver granted by FDA will become effective on the date that 
notice of the waiver is published in the Federal Register.


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

    FDA may modify or revoke a waiver if FDA determines 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 FDA determines 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.

    Dated: January 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02188 Filed 1-31-14; 11:15 am]
BILLING CODE 4160-01-P