[Federal Register Volume 69, Number 244 (Tuesday, December 21, 2004)]
[Proposed Rules]
[Pages 76423-76427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-27904]


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DEPARTMENT OF TRANSPORTATION

Research and Special Programs Administration

49 CFR Part 121

[Docket No. RSPA-91-13289; FS-1]
RIN 2137-AC00


Safeguarding Food From Contamination During Transportation

AGENCY: Research and Special Programs Administration (RSPA), DOT.

[[Page 76424]]


ACTION: Supplemental notice of proposed rulemaking (SNPRM).

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SUMMARY: RSPA is proposing to address the safe transportation of food 
and food products in commerce by referencing in its regulations 
requirements of the U.S. Department of Agriculture and the Food and 
Drug Administration of the U.S. Department of Health and Human Services 
that apply to persons who offer for transportation or transport food in 
commerce by motor vehicle or rail car. This action is intended to 
implement the Sanitary Food Transportation Act of 1990.

DATES: Comments must be received by January 20, 2005.

ADDRESSES: You may submit comments by any of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the 
online instructions for submitting comments.
    Web Site: http://dms.dot.gov. Follow the instructions for 
submitting comments on the DOT electronic docket site. You may view the 
public docket through the Internet at http://dms.dot.gov or in person 
at the Docket Management System office at the address indicated below 
for ``Hand Delivery.''
    E-mail: Include the Docket Identification Number, RSPA-91-13289 
(FS-1), in the subject line of the message.
    Fax: 1-202-493-2251.
    Mail: Docket management System, U.S. Department of Transportation, 
400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 
20590-0001.
    Hand Delivery: To the Dockets Management System; Room PL-401 on the 
plaza level of the Nassif Building, 400 Seventh Street, SW., 
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, 
except Federal Holidays.
    Instructions: You must include the agency name (Research and 
Special Programs Administration) and docket number (RSPA-91-13289 (FS-
1)) or the Regulatory Identification Number (RIN) for this notice at 
the beginning of your comments. You should submit two copies of your 
comments, if you submit them by mail. If you wish to receive 
confirmation that RSPA received your comments, you should include a 
self-addressed stamped postcard. Note that all comments received will 
be posted without change to http://dms.dot.gov, including any personal 
information provided, and will be accessible to Internet users. Please 
see the Privacy Act section of this document.

FOR FURTHER INFORMATION CONTACT: Helen Engrum, Office of Hazardous 
Materials Standards, RSPA, 202-366-8553.

SUPPLEMENTARY INFORMATION:

I. Background

    The Sanitary Food Transportation Act of 1990 (SFTA; 49 U.S.C. 5701 
et seq.) requires the Secretary of Transportation (the Secretary) to 
promulgate regulations to promote the safe transportation of food 
products. Among other requirements, SFTA requires the Secretary, in 
consultation with the Secretary of Health and Human Services, the 
Secretary of Agriculture, and the Administrator of the Environmental 
Protection Agency, to: (1) Issue regulations with respect to the 
transportation of food, food additives, drugs, devices, and cosmetics, 
as defined in the Food, Drug, and Cosmetic Act, in motor vehicles or 
rail cars that are used to transport either refuse or non-food products 
that could make the food unsafe as a result of such transportation; (2) 
issue regulations governing the construction and use of cargo tanks and 
rail cars used to transport food products, including prohibiting the 
transportation of food products in cargo tanks and rail cars used to 
transport non-food products that would make the products unsafe; and 
(3) designate and publish a list of non-food products that may not be 
transported in cargo tanks and tank cars that are also used to 
transport food products. The Secretary delegated the authority to issue 
regulations under SFTA to the Research and Special Administration 
(RSPA, us). 49 CFR 1.53(i).

II. Federal Food Safety Responsibilities

    The U.S. Department of Agriculture (USDA) is responsible for 
regulating meat, poultry, and eggs and egg products under authority of 
the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry 
Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Product 
Inspection Act (21 U.S.C. 1031 et seq.). In carrying out its 
responsibilities, USDA conducts inspections of warehouses, 
transporters, retail stores, restaurants, and other places where meat, 
poultry, and egg products are handled and stored. The Food and Drug 
Administration (FDA) of the Department of Health and Human Services 
(HHS) has responsibility for food safety (including transportation) 
under the Food, Drug, and Cosmetics Act (21 U.S.C. 332 et seq.). In 
carrying out its responsibilities, FDA conducts inspections of 
establishments not otherwise regulated by USDA that manufacture, 
process, pack, or hold foods. FDA also inspects vehicles and other 
conveyances, such as boats, trains, and airplanes, in which foods are 
transported or held in interstate commerce.

III. Previously Published NPRM

    On May 21, 1993, we published an NPRM (58 FR 29698) proposing 
regulations to implement SFTA. The NPRM proposed to restrict a cargo 
tank, tank car, or portable tank to the carriage of either food 
products or non-food products. We did not identify any non-food 
products that would be safe to transport in a tank vehicle that carries 
food products and, therefore, did not propose an ``acceptable non-food 
product list.'' For other motor vehicles and rail cars, the proposal 
would forbid the transportation of food products in the same vehicle as 
Division 6.1 (poisons) and Division 6.2 (infectious substances) 
materials, and hazardous and solid wastes. However, the NPRM proposed 
to permit these unacceptable materials to be transported in vehicles 
also used to transport food products provided the vehicle is free of 
any contaminating residues. We received 80 comments in response to the 
NPRM from food producers and processors, chemical companies, 
transportation companies, and state government agencies. The commenters 
addressed proposals in the NPRM applicable to communication standards, 
recordkeeping requirements; vehicle utilization standards; design and 
material standards for construction of cargo tanks, portable tanks, and 
tank cars; minimum insurance or liability requirements; lists of 
``acceptable non-food products'' and ``unacceptable non-food 
products''; and a waiver program. Commenters generally opposed the 
proposals in the NPRM. Several commenters recommended that DOT defer to 
FDA and USDA on food safety issues. For example, the National Food 
Processors Association, on behalf of twenty food related trade 
associations, stated that implementation of SFTA should be transferred 
from DOT to FDA and USDA. The National Institute of Oilseed Products 
and Hudson Tank Terminals Corporation recommended that RSPA incorporate 
by reference the FDA regulations applicable to food safety. Exxon 
Chemical Americas stated that ``the current FDA strictures prohibiting 
`adulteration' are sufficient to insure the safety of [food] 
additives.'' Conagra stated that ``Detailed specifications for food 
contact surfaces [of tanks and tank vehicles] is unnecessary, 
particularly in light of the existence of regulations already 
promulgated by the Food and Drug

[[Page 76425]]

Administration and the U.S. Department of Agriculture.'' GE Medical 
Systems stated that compliance with FDA regulations ``adequately 
protects medical devices from contamination during transportation,'' 
and FDA's required reports of any malfunction of a medical device make 
a separate ``DOT incident reporting system'' unwarranted.

IV. Proposals in This SNPRM

    Since publication of the NPRM in 1993, the Department, in 
coordination with USDA and FDA, has concluded that the expertise for 
ensuring the safety of our nation's food supply, including 
transportation, lies with USDA and FDA. These agencies agree that the 
public interest regarding the safe transportation of food will be more 
effectively served and better addressed by building on the present 
statutory authority, existing enforcement and technical expertise, and 
operational framework already established within USDA and FDA. 
Implementation of a food transportation safety program under DOT would 
require unnecessary duplication of personnel and funds to promulgate 
regulations and to conduct certain training, research, and testing 
activities and could result in duplication, overlap, or conflict with 
current or pending HHS or USDA regulations.
    Moreover, both FDA and USDA have regulations in place or have 
issued guidelines and recommendations that address the sanitary food 
issues highlighted in SFTA. For example, on July 25, 1996 (61 FR 
38805), USDA published a final rule requiring food processors who 
handle meat, poultry, or egg products to implement Hazard Analysis and 
Critical Control Point (HACCP) systems to identify points in the food 
production process where contamination or adulteration could occur and 
implement measures to reduce or eliminate the possibility of 
contamination (9 CFR Part 417 and related provisions in 9 CFR Parts 
304, 327, and 381). The hazard analysis required by the USDA HACCP 
regulations must address food safety hazards that can occur before, 
during, and after entry of the food or food product into the 
establishment, including hazards that can occur during transportation. 
USDA regulations require transport vehicles used to transport meat, 
poultry, and egg products to be reasonably free of foreign matter (such 
as dust, dirt, rust, or other articles or residues) and free of 
chemical residues so that products will not be adulterated. Further, 
any cleaning compound, lye, soda solution, or other chemical used in 
cleaning a transport vehicle must be thoroughly removed prior to its 
use (see 9 CFR Parts 326 and 381).
    On January 19, 2001 (66 FR 6138), FDA adopted regulations requiring 
juice processors to develop and implement HACCP systems for their 
processing operations (9 CFR Part 120). The regulations are similar to 
the USDA HACCP regulations and require each processor to conduct a 
hazard analysis of food hazards that can be introduced both within and 
outside the processing plant environment, including food hazards that 
can occur before, during, and after harvest and during transportation. 
In addition, FDA regulations establish current good manufacturing 
practices for manufacturing, packing, or holding human food. These 
regulations include requirements for protecting food from contamination 
or adulterations during manufacture and transportation. FDA requires 
finished food to be stored and transported under conditions that will 
protect it against physical, chemical, and microbial contamination (see 
21 CFR 110.93).
    Both USDA and FDA have issued guidelines to assist food processors 
to comply with the HACCP and good manufacturing practices regulations. 
USDA's Food Safety and Inspection Service (FSIS) on August 4, 2003, 
issued ``FSIS Safety and Security Guidelines for the Transportation and 
Distribution of Meat, Poultry, and Egg Products'' (FSIS Guidelines; 68 
FR 45789). The FSIS Guidelines address food safety measure that should 
be taken by shippers from the point of food production through 
delivery. Among other measures, the FSIS Guidelines recommend that 
processors and distributors identify all points of vulnerability where 
there is the potential for vulnerability or contamination to occur and 
define controls to prevent product adulteration and contamination 
during transportation and storage. The FSIS Guidelines address the 
design and construction of vehicles used to transport food and 
sanitizing and maintaining food transportation vehicles. Importantly, 
the FSIS Guidelines recommend that transport vehicles, containers, and 
conveyances should be designated and marked ``for food use only'' and 
be used only for transporting foods and, if feasible, restricted to a 
single commodity. The FSIS Guidelines also include recommendations for 
loading and unloading facilities, loading and unloading procedures, in-
transit procedures to prevent contamination or adulteration, and 
unloading procedures. Finally, the FSIS Guidelines include 
recommendations for enhancing food security before, during, and after 
transportation.
    On April 24, 2003, FDA published ``Guidance on Bulk Transport of 
Juice Concentrates and Certain Shelf Stable Juices'' (Juice Guidance; 
68 FR 20159). The Juice Guidance was developed to assist producers and 
users to develop measures to prevent, reduce to acceptable levels, or 
eliminate the risk of contamination or recontamination of juice 
products during bulk transportation. The guidance describes five major 
areas of concern with bulk transport systems, special considerations 
for tankers, and examples of control measures for loading and unloading 
juice products into tankers. The Juice Guidance recommends that a 
producer or user conduct a hazard analysis focused on five areas of 
concern with bulk transport: (1) Sanitation operations, (2) equipment 
design, (3) equipment maintenance, (4) employee practices, and (5) 
loading and unloading areas. The Juice Guidance includes 
recommendations for designing vehicles used for the transportation of 
bulk amounts of juice products, preventive maintenance programs to 
ensure proper functioning of equipment and integrity of food contact 
surfaces, and measures for cleaning and sanitizing tanker trucks used 
to transport juice. The Juice Guidelines recommend that producers use 
tankers that are dedicated to the transportation of juice products. The 
Juice Guidelines also include recommendations for loading and unloading 
a tanker.
    Taken together, the USDA and FDA regulations and implementing 
guidance adequately address the overarching SFTA goal of protecting 
food and food products from contamination during transportation. 
Indeed, the USDA and FDA regulations and implementing guidance address 
many of the specific provisions of SFTA, including the contamination or 
adulteration of food with non-food products, identification of vehicles 
used to transport food and food products, the use of dedicated 
vehicles, and the design of vehicles used to transport food and food 
products. Substantive DOT regulations in this area are, therefore, not 
necessary. Accordingly, in this SNPRM, we propose to reference the USDA 
and FDA regulations and state that persons who offer for transportation 
or transport food or food products must comply with the USDA and FDA 
regulations applicable to such transportation. This approach maintains 
current food safety

[[Page 76426]]

responsibility with the agencies that are best equipped to meet that 
responsibility. We will continue to work with USDA and FDA to assist 
them as necessary to assure that food and food products are transported 
safely. To this end, DOT will establish procedures for transportation 
safety inspections for the purpose of recognizing suspected incidents 
of contamination or adulteration of food, and will train DOT personnel 
in the appropriate use of the procedures. DOT will promptly notify FDA 
or USDA, as applicable, of any instances of potential food 
contamination or adulteration identified during safety inspections.
    USDA/FSIS and FDA both plan to work with DOT to create a memorandum 
of understanding to ensure that the agencies work together effectively 
to assure that the Nation's food supply is safe and secure, 
particularly in the distribution channels involving transportation. 
FSIS and FDA will provide practical information regarding their 
regulations and activities concerning food safety and security. Drawing 
from vulnerability assessments and technical studies related to food 
safety and security, FSIS and FDA will work with DOT to develop a 
program to protect against vulnerabilities. Further, FSIS and FDA will 
provide guidance to and coordinate with DOT on sharing of significant 
information resulting from DOT safety inspections. FSIS and FDA will 
work with DOT to develop standard training for transportation 
inspectors to enable them to recognize suspected incidents of 
contamination or adulteration or other potential food safety or 
security concerns encountered during their inspections and to report 
these incidents to FSIS or FDA.
    In this SNPRM, we propose to add a new Part 121 to Subchapter B of 
Title 49 of the Code of Federal Regulations. As proposed, Part 121 
includes definitions applicable to the transportation of food and food 
products and states that persons engaged in such transportation must 
comply with USDA regulations in 9 CFR Parts 1 through 599 and FDA 
regulations at 21 CFR Parts 1 through 1299.
    In addition, in this SNPRM, we propose to include in Part 121 a 
recommendation that persons engaged in the transportation of food or 
food products utilize food safety standards and guidelines promulgated 
by FDA and USDA, including FDA guidance documents on food security 
applicable to dairy farms and milk processors, food producers and 
processors, and bulk transporters of juice; and USDA safety and 
security guidelines for the transportation and distribution of meat, 
poultry and egg products.

V. Rulemaking Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

    This SNPRM is a significant regulatory action under section 3(f) of 
Executive Order 12866 and, therefore, was formally reviewed by the 
Office of Management and Budget. This proposed rule is also significant 
under the Regulatory Policies and Procedures of the Department of 
Transportation (44 FR 11034). This proposed rule imposes no new 
compliance costs on the regulated industry; it merely states that 
persons who offer for transportation or transport food or food products 
must comply with current USDA and FDA requirements for such 
transportation.

B. Executive Order 13132

    This proposed rule has been analyzed in accordance with the 
principles and criteria contained in Executive Order 13132 
(``Federalism''). This proposed rule does not propose any regulation 
that has substantial direct effects on the States, the relationship 
between the national government and the States, or the distribution of 
power and responsibilities among the various levels of government. 
Therefore, the consultation and funding requirements of Executive Order 
13132 do not apply.

C. Executive Order 13175

    This proposed rule has been analyzed in accordance with the 
principles and criteria contained in Executive Order 13175 
(``Consultation and Coordination with Indian Tribal Governments''). 
Because this proposed rule does not have tribal implications and does 
not impose direct compliance costs, the funding and consultation 
requirements of Executive Order 13175 do not apply.

D. Regulatory Flexibility Act and Executive Order 13272

    The Regulatory Flexibility Act (5 U.S.C. 601-611) requires each 
agency to analyze proposed regulations and assess their impact on small 
businesses and other small entities to determine whether the proposed 
rule is expected to have a significant impact on a substantial number 
of small entities. The SNPRM imposes no new transportation costs. 
Therefore, RSPA certifies that this proposed rule would not have a 
significant economic impact on a substantial number of small entities.
    Need for the SNPRM. SFTA requires the Secretary of Transportation 
to promulgate regulations to promote the safe transportation of food 
products.
    Description of Actions. In this SNPRM, we are proposing to state 
that persons who offer for transportation or transport food or food 
products in commerce must comply with USDA and FDA regulations 
applicable to such transportation. In addition, we are including a 
recommendation that persons engaged in the transportation of food or 
food products utilize food safety and security standards and guidelines 
promulgated by FDA and USDA.
    Identification of potentially affected small entities. Businesses 
likely to be affected by the SNPRM are the more than 22,000 
establishments that comprise North American Industrial Classification 
System (NAICS) Group 311, which includes food processors and 
manufacturers, and the more than 2,300 establishments that comprise 
NAICS Group 312, which includes beverage processors and manufacturers. 
In addition, the SNPRM will have an impact on over 43,000 specialized 
trucking companies (NAICS 48422). Finally, the proposals in this SNPRM 
will affect approximately 1.9 million farmers and farming operations.
    Unless alternative definitions have been established by the agency 
in consultation with the Small Business Administration (SBA), the 
definition of ``small business'' has the same meaning as under the 
Small Business Act. Since no such special definition has been 
established, we employ the thresholds published by SBA for 
establishments that will be subject to the proposed sanitary food 
requirements. Based on data for 1997 compiled by the U.S. Census 
Bureau, it appears that about 97 percent of food and beverage 
processors and specialized trucking entities are small businesses. SBA 
has not established definitions for farms and farming operations. 
Therefore, we are using the definition used by USDA; USDA defines small 
farms as those with revenues under $500,000. Using this criterion, 
about 96 percent of all farms are considered small entities. These 
entities would incur no increased costs to comply with the provisions 
of this SNPRM.
    Reporting and recordkeeping requirements. This SNPRM includes no 
new requirements for reporting or recordkeeping.
    Related Federal rules and regulations. As noted earlier in this 
preamble, both USDA and FDA have comprehensive sanitary food 
regulations and guidelines. Rather than impose new and possibly 
conflicting requirements, we are incorporating the USDA and FDA 
standards into the DOT regulations.
    Alternate proposals for small businesses. The Regulatory 
Flexibility

[[Page 76427]]

Act directs agencies to establish exceptions and differing compliance 
standards for small businesses, where it is possible to do so and still 
meet the objectives of applicable regulatory statutes. In the case of 
sanitary food transportation, it is not possible to establish 
exceptions or differing standards and still accomplish the objectives 
of SFTA.
    This SNPRM was developed under the assumption that small businesses 
make up the overwhelming majority of entities that will be subject to 
its provisions. Thus, the SNPRM proposes no new requirements; rather it 
incorporates existing requirements of other agencies into the DOT 
regulations.
    Conclusion. We conclude that while this SNPRM applies to a 
substantial number of small entities, there will not be a significant 
economic impact on those small entities. There are no new compliance 
costs associated with the proposals in this SNPRM.
    This proposed rule has been developed in accordance with Executive 
Order 13272 (``Proper Consideration of Small Entities in Agency 
Rulemaking'') and DOT's procedures and policies to promote compliance 
with the Regulatory Flexibility Act to ensure that potential impacts of 
draft rules on small entities are properly considered.

F. Unfunded Mandates Reform Act of 1995

    This proposed rule would not impose unfunded mandates under the 
Unfunded Mandates Reform Act of 1995. It would not, if adopted, result 
in costs of $100 million or more, in the aggregate, to any of the 
following: State, local, or Native American tribal governments, or the 
private sector.

G. Paperwork Reduction Act

    This SNPRM imposes no new information collection requirements.

H. Regulation Identifier Number (RIN)

    A regulation identifier number (RIN) is assigned to each regulatory 
action listed in the Unified Agenda of Federal Regulations. The 
Regulatory Information Service Center publishes the Unified Agenda in 
April and October of each year. The RIN number contained in the heading 
of this document may be used to cross-reference this action with the 
Unified Agenda.

I. Environmental Assessment

    The National Environmental Policy Act of 1969 (NEPA), as amended 
(42 U.S.C. 4321-4347), requires Federal agencies to consider the 
consequences of major federal actions and prepare a detailed statement 
on actions significantly affecting the quality of the human 
environment. There are no significant environmental impacts associated 
with this proposed rule.

J. Privacy Act

    Anyone is able to search the electronic form for all comments 
received into any of our dockets by the name of the individual 
submitting the comments (or signing the comment, if submitted on behalf 
of an association, business, labor union, etc.). You may review DOT's 
complete Privacy Act Statement in the Federal Register published on 
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit 
http://dms.dot.gov.

List of Subjects in 49 CFR Part 121

    Food, Transportation.

    In consideration of the foregoing, we propose to amend subchapter B 
of title 49, subtitle B, chapter I, as follows:
    1. Revise the heading for subchapter B of title 49, subtitle B, 
chapter I, to read as follows:

Subchapter B--Food Safety and Oil Transportation

    2. Add part 121 to subchapter B of title 49, subtitle B, chapter I, 
to read as follows:

PART 121--FOOD SAFETY REGULATIONS

Sec.
121.1 Purpose and scope.
121.5 Definitions.
121.10 General requirements.
121.15 Use of guidance documents and material.

    Authority: 49 U.S.C. 5701-5714; 49 CFR 1.53.


Sec.  121.1  Purpose and scope.

    This part prescribes requirements for persons who offer for 
transportation or transport food and food products by rail car or motor 
carrier in commerce.


Sec.  121.5  Definitions.

    For purposes of this part:
    FDA means the Food and Drug Administration of the U.S. Department 
of Health and Human Services.
    Food and Food product have the same meanings as in section 201 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
    Motor vehicle means a vehicle, machine, tractor, trailer, or 
semitrailer, or any combination thereof, propelled or drawn by 
mechanical power and used on the highways for the transportation of 
passengers or property.
    Person means an individual, firm, copartnership, corporation, 
company, association, or joint-stock association (including any 
trustee, receiver, assignee, or similar representative) that offers for 
transportation or transports food or food products in transportation.
    Rail car means a car designed to carry freight by rail and includes 
a box car, flat car, gondola car, hopper car, or tank car.
    Transports and Transportation mean any movement of property in 
commerce by motor vehicle or rail car.
    USDA means the U.S. Department of Agriculture.


Sec.  121.10  General requirements.

    No person may offer for transportation or transport food or food 
products by motor vehicle or rail car except in conformance with 
applicable requirements governing such transportation in 9 CFR parts 1 
through 599 and 21 CFR parts 1 through 1299.


Sec.  121.15  Use of guidance documents and material.

    Each person who offers for transportation or transports food or 
food products by motor vehicle or rail car should utilize guidance 
documents and materials promulgated by FDA and USDA, including, but not 
limited to: FDA Guidance on Bulk Transport of Juice Concentrates and 
Certain Shelf Stable Juices; FDA Guidance on Food Security Preventive 
Measures for Food Producers, Processors, and Transporters; FDA Guidance 
on Food Security Preventive Measures for Diary Farms, Bulk Milk 
Transporters, Bulk Milk Transfer Stations, and Fluid Milk Processors; 
and USDA Food Safety and Inspection Service Safety and Security 
Guidelines for the Transportation and Distribution of Meat, Poultry, 
and Egg Products.

    Issued in Washington, DC, on December 16, 2004, under authority 
delegated in 49 CFR 1.53(i).
Robert A. McGuire,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 04-27904 Filed 12-20-04; 8:45 am]
BILLING CODE 4910-60-P