Implementation of Sanitary Food Transportation Act of 2005, 22713-22723 [2010-10078]

Agencies

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

[Federal Register Volume 75, Number 83 (Friday, April 30, 2010)]
[Proposed Rules]
[Pages 22713-22723]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10078]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2010-N-0013]
RIN 0910-AG52


Implementation of Sanitary Food Transportation Act of 2005

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Advance notice of proposed rulemaking.

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SUMMARY:  The Food and Drug Administration (FDA) is issuing an advance 
notice of proposed rulemaking (ANPRM) to request data and information 
on the food transportation industry and its practices. FDA also is

[[Page 22714]]

requesting data and information on the contamination of transported 
foods and any associated outbreaks. FDA is taking this action as part 
of its implementation of the Sanitary Food Transportation Act of 2005 
(2005 SFTA), which requires the Secretary of Health and Human Services 
(HHS) to issue regulations setting forth sanitary transportation 
practices to be followed by shippers, carriers by motor vehicle or rail 
vehicle, receivers, and others engaged in food transport. This action 
is also part of a larger agency effort to focus on prevention of food 
safety problems throughout the food chain. The regulations would 
address the risks to human or animal health associated with the 
transportation of food.

DATES:  Submit electronic or written comments by August 30, 2010.

ADDRESSES:  You may submit comments, identified by Docket No. FDA-2010-
N-0013, by any of the following methods:
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, disk, or CD-ROM 
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 
and docket number 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:
    Regarding the provisions with respect to human food: Michael 
Kashtock, Center for Food Safety and Applied Nutrition (HFS-317), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740-3835, 301-436-2022.
    Regarding the provisions with respect to food for animals: Shannon 
Jordre, Center for Veterinary Medicine (HFV-235), Food and Drug 
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9229.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this ANPRM as part of its implementation of the 2005 
SFTA, which requires the Secretary of HHS to issue regulations setting 
forth sanitary transportation practices to be followed by shippers, 
carriers by motor vehicle or rail vehicle, receivers, and others 
engaged in food transport. Food is defined by section 201(f) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(f)) as 
``articles used for food or drink for man or other animals, chewing 
gum, and articles used for components of any such article.'' FDA notes 
that ``food'' includes live animals intended for food use and food such 
as meat and poultry during transport outside of official U.S. 
Department of Agriculture (USDA) establishments.\1\ \2\ This ANPRM is 
also part of a larger agency effort to focus on prevention of food 
safety problems throughout the food chain; preventing harm to consumers 
is the primary principle described in the Key Findings of the 
President's Food Safety Working Group (Ref. 3). The regulations would 
address the risks to human or animal health associated with the 
transportation of food.
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    \1\ With regard to the latter, FDA notes that, to prevent 
duplication of effort, its compliance policy is to inform the USDA's 
Food Safety and Inspection Service (FSIS) when an apparent violation 
is encountered involving a meat or poultry product that has left a 
USDA inspected establishment (Ref. 1). FDA will not normally 
initiate action involving such products unless USDA does not wish to 
do so. As FDA moves forward to implement the SFTA, FDA intends to 
consult with FSIS to harmonize new regulations with current 
regulations as practicable.
    \2\ USDA's Food Safety and Inspection Service (FSIS) has issued 
guidelines entitled ``FSIS Safety and Security Guidelines for the 
Transportation and Distribution of Meat, Poultry, and Egg Products'' 
(Ref. 2).
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A. Risk for Foodborne Illness Associated With Transportation of Food

    Over the past few decades, there have been persistent concerns 
about the potential that food might become contaminated during 
transportation; however, only a limited number of such events have been 
documented. In this section, we discuss the events we are aware of, in 
chronologic order. The first two events described in the following 
paragraphs involved contamination of food for animals; the remainder 
concerned food for humans.
    In 1974, an incident involving contamination of a component of food 
for animals in a rail car occurred. This case, which FDA investigated 
after receiving reports of several sickened dogs, involved corn gluten 
used in dog food. The corn gluten was determined to have been 
transported in a rail car that had been previously used to transport 
lead monoxide. Samples taken of the dog food in which the corn gluten 
was used revealed that it was contaminated with lead monoxide at levels 
ranging up to 28,000 parts per million. A Class I recall was issued for 
the dog food and other food for animals manufactured at the same plant 
within the same time period. Additionally, FDA successfully prosecuted 
the carrier involved in this incident. See United States v. Penn 
Central Transportation Co. (S.D. Ill 1978) (Refs. 4 and 5).
    In 1989, soybean hulls used as a component in animal feed were 
contaminated by barium carbonate, a chemical used in rat poison and 
paint, when they were transported in a rail car that had previously 
been used to transport the chemical (Refs. 6 and 7). The soybean hulls 
were incorporated into bulk dairy cow feeds distributed to farms in 
Louisiana and Texas. The contamination resulted in the deaths of dairy 
cows in herds from both Louisiana and Texas, and high levels of barium 
carbonate were detected in milk from two of the affected herds by the 
State of Louisiana. The manufacturer of the animal feed voluntarily 
recalled implicated feeds.
    During the late 1980s, there were a number of press reports that 
some trucks that hauled garbage from the New York/New Jersey area to 
Midwestern landfills were used subsequently to carry meat, poultry, and 
produce (Ref. 8). An investigation by the U.S. General Accounting 
Office (GAO, now called the Government Accountability Office) found 
only limited, anecdotal information about food being transported in 
trucks that previously carried garbage, the types of trucks doing so, 
and the foodstuffs carried (Ref. 8). However, in its report (the 1990 
GAO report), GAO concluded that long-distance transport of garbage was 
clearly on the increase. GAO also concluded that long-distance 
transport of garbage primarily originated in certain northeastern 
communities that generate more garbage than they can dispose of 
locally. In these communities, the quantity of consumer goods, 
including food, arriving by truck exceeded the quantity of goods 
leaving, and garbage had become a paying trucking

[[Page 22715]]

commodity on what might otherwise be an empty return trip (Ref. 8). GAO 
concluded that the extent to which the same trucks might subsequently 
carry food could not be determined at the time of the report because 
federal regulations did not require that type of recordkeeping.
    In 1994, a large multi-state outbreak of salmonellosis was 
associated with an ice cream mix that became contaminated during 
transport in tanker trucks that had previously hauled raw liquid eggs 
(Ref. 9). Public health officials who analyzed data and information 
associated with 150 confirmed cases of salmonellosis in the State of 
Minnesota concluded that the outbreak may have affected more than 
29,000 persons in Minnesota and more than 224,000 persons nationwide 
(Ref. 9).
    In July 1999, an outbreak of Salmonella Muenchen occurred in 15 
States and 2 Canadian provinces with more than 300 cases reported (66 
FR 6138 at 6172, January 19, 2001). The product was fresh orange juice, 
a portion of which was imported. Several serotypes of Salmonella were 
isolated from tanker truckloads of juice tested at the United States/
Mexican border. In such circumstances, there is a potential that 
Salmonella from one contaminated shipment could contaminate future 
shipments.
    In 2007, the Motor Carrier Division of the Michigan State Police 
reported 22 cases of illegal and unsafe food transport on Michigan 
highways during 2006 (Ref. 10). The report listed findings such as:
     Raw poultry hanging from the roof inside the cargo area of 
a truck, with juices dripping onto open boxes of produce below, and 
with juices from the raw poultry dripping out onto the pavement from 
under the rear cargo box doors. The food was being transported in an 
unrefrigerated truck with an internal temperature greater than 70[deg] 
F;
     Truck(s) with no refrigeration unit;
     Truck(s) with the refrigeration unit turned off or not 
working; and
     Truck(s) with a working refrigeration unit that was not 
set at the correct temperature.
    As with the 1999 transport of contaminated orange juice in tanker 
truckloads, recent outbreaks of foodborne disease demonstrate the 
possibility of contaminated foods being widely transported, which could 
lead to cross-contamination between shipments. For example, in 2009, 
peanut butter and peanut paste were confirmed as the source of a large 
multi-state outbreak caused by Salmonella Typhimurium (74 FR 10598, 
March 11, 2009). These peanut-derived products were manufactured by two 
facilities owned by a single firm and distributed through various 
channels (Refs. 11 and 12). The firm recalled a large number of its 
products, including products distributed in 1,700-pound tanker 
containers, because the products had the potential to be contaminated 
with Salmonella (Ref. 13).

B. Sanitary Food Transportation Act of 1990 and Associated Actions by 
the U.S. Department of Transportation

    After receiving the 1990 GAO report, Congress enacted the Sanitary 
Food Transportation Act of 1990 (1990 SFTA) (49 U.S.C. 5701 et seq. 
(2000), amended by Public Law 109-59 (2005)). The 1990 SFTA directed 
the U.S. Department of Transportation (DOT) to prescribe regulations 
regarding the transportation of food and food additives (including food 
and food additives intended for consumption by animals) in motor 
vehicles and rail vehicles that are used to transport nonfood products 
that would make the food or food additives unsafe to humans or 
animals.\3\ In essence, the 1990 SFTA directed DOT to establish 
regulations to prevent food or food additives transported in tank 
trucks, rail tank cars, or cargo tanks (tank vehicles) from being 
contaminated by nonfood products that are simultaneously or previously 
transported in those tank vehicles. Section 5704(b) of the 1990 SFTA 
specifically directed DOT to publish a list of acceptable nonfood 
products that DOT (in consultation with the Secretaries of the USDA, 
U.S. Department of Health and Human Services (HHS), and the 
Administrator of the Environmental Protection Agency) determined would 
not make food or food additives unsafe to humans or animals because of 
transportation of the nonfood products in a tank vehicle used to 
transport food or food additives.
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    \3\ The 1990 SFTA also directed DOT to prescribe regulations 
regarding the transportation of cosmetics, devices, or drugs in 
motor vehicles and rail vehicles that are used to transport nonfood 
products that would make the cosmetics, devices, or drugs unsafe to 
humans. We do not discuss those provisions in this document.
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    On May 21, 1993, DOT's Research and Special Programs Administration 
(RSPA) issued a notice of proposed rulemaking (the 1993 NPRM) (58 FR 
29698) that would restrict a cargo tank, tank car, or portable tank to 
carrying either food products or nonfood products. Under the 1993 NPRM, 
a cargo tank, tank car, or portable tank that carried food products 
would have been prohibited from carrying nonfood products. In the 1993 
NPRM, RSPA stated that it had not identified any nonfood products that 
were acceptable to be carried in a tank vehicle that carries food 
products and, therefore, was not issuing a list of acceptable nonfood 
products within the meaning of section 5704(b) of the 1990 SFTA. For 
motor and rail vehicles other than tank vehicles, RSPA also proposed to 
forbid the transportation of food products in the same vehicle as 
poisons, infectious substances, hazardous wastes, or solid wastes 
(i.e., ``unacceptable nonfood products''). However, such vehicles would 
be allowed to carry unacceptable nonfood products before or after they 
carried food products, provided the vehicles were free of any 
contaminating residues.
    Subsequent to the publication of the 1993 NPRM, in a report issued 
on March 27, 1998, DOT's Office of the Inspector General (DOT/OIG) 
found that (1) DOT did not have the expertise to implement the 1990 
SFTA, (2) performing food inspections could be incompatible with 
significant aspects of DOT's safety inspection operations, and (3) FDA 
had the requisite expertise, capability, and a directly related primary 
mission for regulating food safety (Ref. 14). DOT/OIG concluded that 
HHS/FDA should have primary responsibility for food transportation 
safety (Ref. 14).
    Comments to the 1993 NPRM generally opposed its proposed provisions 
and recommended that DOT defer to FDA and USDA on food safety issues 
(69 FR 76423, December 21, 2004). In light of both these comments and 
the 1998 report of DOT/OIG, RSPA issued a supplemental notice of 
proposed rulemaking (69 FR 76423, December 21, 2004) (the 2004 SNPRM). 
Under the 2004 SNPRM, RSPA's regulations would reference requirements 
and recommendations, established by USDA or FDA, applying to persons 
who transport (or offer for transportation) food or food products by 
motor vehicle or rail car.
    RSPA did not issue a final rule based on the 2004 SNPRM. Following 
the enactment of the 2005 SFTA (see discussion in section I.D of this 
document), which amended the 1990 SFTA and directed HHS (and, by 
delegation, FDA) to issue regulations prescribing sanitary 
transportation practices to ensure the safe transportation of food, 
DOT's Pipeline and Hazardous Materials Safety Administration (formerly 
RSPA) withdrew both the 1993 NPRM and the 2004 SNPRM (70 FR 76228, 
December 23, 2005).

[[Page 22716]]

C. The 1996 Joint ANPRM

    In 1996, FDA and FSIS jointly issued an advance notice of proposed 
rulemaking (61 FR 59372, November 22, 1996) (the 1996 joint ANPRM). FDA 
and FSIS issued the 1996 joint ANPRM in part to address FDA's safety 
concerns regarding the transportation of food raised by a 1994 outbreak 
of salmonellosis involving ice cream mix that became contaminated 
during transport in tanker trucks that had previously hauled raw liquid 
eggs (Ref. 9). In the 1996 joint ANPRM, FDA and FSIS requested comments 
and information about approaches FDA and FSIS might take, under 
existing legal authorities, to foster food safety improvements that may 
be needed in the transportation and storage of potentially hazardous 
foods.\4\
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    \4\ As discussed in the 1996 joint ANPRM (61 FR 59372), 
potentially hazardous foods, including meat, poultry, eggs and egg 
products, fish, seafood, and dairy products, are those that are 
capable of supporting the rapid multiplication of microorganisms 
that cause foodborne illness. Currently, we generally use the term 
``Time/Temperature Control for Safety (TCS) Food'' rather than 
``potentially hazardous food'' and define a TCS food as a food that 
requires time/temperature control for safety to limit pathogenic 
microorganism growth or toxin formation (Ref. 14). Examples of TCS 
foods include the foods identified as potentially hazardous foods in 
the 1996 joint ANPRM, and plant foods such as raw seed sprouts and 
cut melons (Ref. 14).
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    FDA took no subsequent action on the 1996 joint ANPRM. Data and 
information received in response to the 1996 joint ANPRM are now more 
than 10 years old.

D. The 2005 SFTA

    In 2005, Congress passed the 2005 SFTA, Public Law 109-59, 119 
Stat. 1911, which:
     Requires the Secretary of HHS to issue regulations setting 
forth sanitary transportation practices to be followed by shippers, 
carriers by motor vehicle or rail vehicle, receivers, and others 
engaged in food transport; and
     Requires the Secretary of DOT, in consultation with the 
Secretaries of HHS and USDA, to establish procedures for transportation 
safety inspections for the purpose of identifying suspected incidents 
of contamination or adulteration of a food.\5\
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    \5\ The procedures DOT would establish are outside the scope of 
this document. We intend to assist DOT as appropriate in developing 
DOT's procedures for these inspections.
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1. Our Responsibilities Under Section 416 of the Act
    The statutory authority in section 416 of the act extends to 
broader aspects of the sanitary transportation of food than the 
statutory authority in the 1990 SFTA, which was primarily directed 
toward preventing the contamination of food products by previously 
hauled nonfood products. The authority in section 416 of the act places 
a statutory obligation upon HHS (and, by delegation, to FDA) to issue 
regulations establishing requirements for the food transportation 
industry to use sanitary transportation practices to ensure that food 
is not transported under conditions that may render food adulterated. 
We describe key provisions of section 416 of the act in the following 
bulleted paragraphs.
     Section 416(b) (21 U.S.C. 350e(b)) requires us to 
establish regulations requiring shippers, carriers by motor vehicle or 
rail vehicle, receivers, and other persons engaged in the 
transportation\6\ of food to use sanitary transportation practices 
prescribed by us to ensure that food is not transported under 
conditions that may render the food adulterated.
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    \6\ ``Transportation'' is defined by section 416(a)) of the act 
(21 U.S.C. 350e(a)) as ``any movement in commerce by a motor vehicle 
or rail vehicle.''
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     Section 416(c) (21 U.S.C. 350e(c)) addresses the content 
of the regulations to be established under section 416(b).
    [cir] Section 416(c)(1) (21 U.S.C. 350e(c)(1)) requires these 
regulations to prescribe such practices as we determine to be 
appropriate relating to: (A) sanitation; (B) packaging, isolation, and 
other protective measures; (C) limitations on the use of vehicles; (D) 
information to be disclosed (to a carrier by a person arranging for the 
transportation 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\7\ for the transportation of food); and 
(E) recordkeeping.
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    \7\ ``Bulk vehicle`` is defined by section 416(a) of the act as 
``a tank truck, hopper truck, rail tank car, hopper car, cargo tank, 
portable tank, freight container, or hopper bin, and any other 
vehicle in which food is shipped in bulk, with the food coming into 
direct contact with the vehicle.''
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    [cir] Section 416(c)(2) (21 U.S.C. 350e(c)(2)) requires these 
regulations to include: (A) a list of nonfood products that we 
determine may, if shipped in a bulk vehicle, render adulterated food 
that is subsequently transported in the same vehicle; and (B) a list of 
nonfood products that we determine 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 416(d) (21 U.S.C. 350e(d)) provides that we may 
waive any requirement under section 416, with respect to any class of 
persons, vehicles, food, or nonfood products, if we determine that the 
waiver (A) will not result in the transportation of food under 
conditions that would be unsafe for human or animal health; and (B) 
will not be contrary to the public interest. We must publish in the 
Federal Register any waiver and the reasons for the waiver.
     Section 416(e) (21 U.S.C. 350e(e)) provides that State or 
local requirements concerning transportation of food are preempted if: 
(A) complying with both the State or local requirement and section 416, 
or a regulation prescribed under section 416, is not possible; or (B) 
the State or local requirement as applied or enforced is an obstacle to 
accomplishing and carrying out section 416 or a regulation prescribed 
under section 416.
2. Amendments to Sections 301, 402, and 703 of the Act
    The 2005 SFTA also amended the act to add or revise provisions as 
follows:
     Sections 402(i) and 301(hh) (21 U.S.C. 342(i) and 
331(hh)): Section 402(i) provides that a food shall be deemed 
adulterated if it is transported or offered for transport by a shipper, 
carrier by motor vehicle or rail vehicle, receiver, or any other person 
engaged in the transportation of food under conditions that are not in 
compliance with regulations issued under section 416 of the act. Under 
section 301(hh), the failure (or the causing thereof) 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 us under section 416 is a 
prohibited act subject to the sanctions and penalties provided in 
Chapter III of the act.
     Sections 703(b) and 301(e) (21 U.S.C. 373(b) and 331(e)): 
Section 703(b) requires any person subject to section 416 to permit a 
designated officer or employee who requests required records (i.e., 
records required to be kept in accordance with section 416(c)(1)(E)) to 
have access to all such records at reasonable times and to copy all 
such records. Under section 301(e), the refusal to permit access to or 
copying of any record as required by section 416, or the failure to 
establish or maintain any record required under section 416, or the 
refusal to permit access to or verification or copying of any such 
required record is a prohibited act subject to the sanctions and 
penalties provided in Chapter III of the act.

[[Page 22717]]

E. Our Current Regulations and Guidance Documents Addressing 
Transportation of Food

    We have addressed the transportation of food in several regulations 
(in Title 21 of the Code of Federal Regulations (21 CFR)) and guidance 
documents that are limited in scope. We describe the most relevant 
regulations and guidance documents in table 1 of this document. The 
regulations DOT proposed in the 2004 SNPRM would have included a 
recommendation that each person who offers for transportation or 
transports food or food products by motor vehicle or rail car use 
guidance documents and materials issued by FDA and USDA, and 
specifically identified three of FDA's guidance documents that were 
then in effect: FDA Guidance on Bulk Transport of Juice Concentrates 
and Certain Shelf Stable Juices; FDA Guidance on Food Security 
Preventive Measures for Dairy Farms, Bulk Milk Transporters, Bulk Milk 
Transfer Stations, and Fluid Milk Processors; and FDA Guidance on Food 
Security Preventive Measures for Food Producers, Processors, and 
Transporters (i.e., the guidances in Refs. 16, 17, and 18).

                  Table 1.--FDA Regulations and Guidances Addressing the Transportation of Food
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     Year &
   Reference*              Title                  Type              Description               Circumstances
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1976 (Sec.       Current Good               Regulation       Requires adequate          Implemented requirements
 225.65; 41 FR    Manufacturing Practice                      cleanout procedures for    in section 501(a)(2)(B)
 52612 at         for Medicated Feeds;                        all equipment used in      of the act (21 U.S.C.
 52618,           Equipment Cleanout                          the manufacture or         351(a)(2)(B))
 November 30,     Procedures                                  distribution of
 1976)                                                        medicated feeds that are
                                                              essential to avoiding
                                                              unsafe contamination of
                                                              feeds with drugs
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1986; (Sec.      Current Good               Regulation       Requires that storage and  Issued as part of a
 110.93 51 FR     Manufacturing Practice                      transportation of          broad revision to our
 22458, June      In Manufacturing,                           finished food be under     current good
 19, 1986)        Packing, Or Holding                         conditions that will       manufacturing practice
                  Human Food; Warehousing                     protect food against       (CGMP) regulations for
                  and Distribution                            physical, chemical, and    food
                                                              microbial contamination
                                                              as well as against
                                                              deterioration of the
                                                              food and the container
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1997 (Sec.       Listing of Specific        Regulation       Requires distributors of   To provide animal feed
 Sec.             Substances Prohibited                       mammalian and              protections by
 589.2000(c)      From Use in Animal Food                     nonmammalian materials     prohibiting the feeding
 through (e);     or Feed; Requirements                       for animal food to         of mammalian protein to
 62 FR 30936,     for renderers;                              provide for measures to    ruminant animals
 June 5, 1997),   Requirements for protein                    avoid commingling or
 updated in       blenders, feed                              cross-contamination of
 2008 (Sec.       manufacturers, and                          the materials
 Sec.             distributors; and
 589.2000(c)      Requirements for persons
 through (e);     that intend to separate
 73 FR 22720,     mammalian and
 April 25,        nonmammalian materials
 2008)
[Related Small
 Entity
 Compliance
 Guide (SECG)
 published in
 1998 (Ref.
 19)]
----------------------------------------------------------------------------------------------------------------
1998; (Ref. 20)  Guide to Minimize          Guidance         Includes recommendations   Issued as part of the
                  Microbial Food Safety                       regarding microbial food   1997 Presidential
                  Hazards for Fresh Fruits                    safety hazards and good    ``Initiative to Ensure
                  and Vegetables\**\                          agricultural and           the Safety of Imported
                                                              management practices       and Domestic Fruits and
                                                              common to the growing,     Vegetables'' (Ref. 21)
                                                              packing, and
                                                              transporting of most
                                                              fresh fruits and
                                                              vegetables
----------------------------------------------------------------------------------------------------------------
2001; (Sec.      Hazard Analysis And        Regulation       Requires that juice        Added to the final rule
 120.24(c)); 66   Critical Control Point                      processors complete a 5-   to address comments
 FR 6138 at       (HACCP) Systems; Process                    log pathogen reduction     expressing concern
 6172, January    Controls                                    treatment and final        about the potential for
 19, 2001)                                                    product packaging within   recontamination or
[Related SECG                                                 a single processing        regrowth of surviving
 published in                                                 facility operating under   pathogens if individual
 2003 (Ref.                                                   CGMPs\***\ (``single       treatments designed to
 22)]                                                         facility requirement'')    achieve a 5-log
                                                                                         reduction are separated
                                                                                         by time or space
----------------------------------------------------------------------------------------------------------------

[[Page 22718]]

 
2003; (Ref. 16)  Guidance on Bulk           Guidance         Provides industry with     Issued in response to a
                  Transport of Juice                          recommendations for        citizen petition
                  Concentrates and Certain                    appropriate control        requesting an exemption
                  Shelf Stable Juices                         measures to use in the     from the requirement in
                                                              bulk transport of          Sec.   120.24(c) when
                                                              covered juice products     certain products
                                                              to ensure that the         manufactured in one
                                                              products do not become     facility are sent to
                                                              contaminated or re-        another facility for
                                                              contaminated with          final packaging
                                                              microbial pathogens
                                                              during bulk transport,
                                                              and stated FDA's intent
                                                              to consider the exercise
                                                              of enforcement
                                                              discretion with respect
                                                              to the single facility
                                                              requirement in Sec.
                                                              120.24(c) provided that
                                                              certain conditions are
                                                              met.
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2003 (updated    Dairy Farms, Bulk Milk     Guidance         Identifies the kinds of    Issued in light of the
 2007); (Ref.     Transporters, Bulk Milk                     preventive measures        potential for tampering
 17)              Transfer Stations and                       operators of bulk milk     or other malicious,
                  Fluid Milk Processors:                      transportation             criminal, or terrorist
                  Food Security Preventive                    operations may take to     actions
                  Measures Guidance                           minimize the risk that
                                                              fluid milk under their
                                                              control will be subject
                                                              to tampering or other
                                                              malicious, criminal, or
                                                              terrorist actions
----------------------------------------------------------------------------------------------------------------
2003 (updated    Food Producers,            Guidance         Identifies the kinds of    Issued in light of the
 2007) (Ref.      Processors, and                             preventive measures        potential for tampering
 18)              Transporters: Food                          operators of human or      or other malicious,
                  Security Preventive                         animal food                criminal, or terrorist
                  Measures Guidance                           establishments             actions
                                                              (including firms that
                                                              distribute or transport
                                                              food or food
                                                              ingredients) may take to
                                                              minimize the risk that
                                                              food under their control
                                                              will be subject to
                                                              tampering or other
                                                              malicious, criminal, or
                                                              terrorist actions
----------------------------------------------------------------------------------------------------------------
2004 (Ref. 19)   Guidance for Industry      Guidance         Provides guidance on       Issued to address health
                  122:                               transport of foods that    risks when raw meat
                  Manufacture and Labeling                    contain raw meat, or       foods are used,
                  of Raw Meat Foods for                       other raw animal           particularly by pet
                  Companion and Captive                       tissues, for consumption   owners
                  Noncompanion Carnivores                     by dogs, cats, other
                  and Omnivores                               companion or pet
                                                              animals, and captive
                                                              noncompanion animal
                                                              carnivores and omnivores
----------------------------------------------------------------------------------------------------------------
2004 (Sec.       Establishment,             Regulation       Requires persons who       Implementation of
 1.352 and Sec.   Maintenance, and                            transport food for         section 306 of the 2002
  Sec.   1.360    Availability of Records:                    humans and animals to      Bioterrorism Act, which
 through 1.363;   What information must                       establish and maintain     directs the HHS
 69 FR 71562,     transporters establish                      records identifying the    Secretary to issue
 December 9,      and maintain?; What are                     immediate previous         regulations requiring
 2004)            the record retention                        source of all food         persons who
[Related SECG     requirements?; What are                     received, and the          manufacture, process,
 published in     the record availability                     immediate subsequent       pack, transport,
 2004 (Ref.       requirements?; What                         recipient of all food      distribute, receive,
 24)]             records are excluded                        released, as well as       hold, or import food
                  from this subpart?; What                    certain other              for humans and animals
                  are the consequences of                     information related to     to establish and
                  failing to establish or                     the transported food;      maintain records
                  maintain records or make                    Sets forth the record      identifying the
                  them available to FDA?                      retention and record       immediate previous
                                                              availability               source of all food
                                                              requirements for           received, and the
                                                              transporters               immediate subsequent
                                                                                         recipient of all food
                                                                                         released
----------------------------------------------------------------------------------------------------------------
2005 (revised    Notice from FDA to         Guidance         Provides information and   Developed following
 2006) (Ref.      Growers, Food                               references that can be     Hurricanes Katrina and
 25)              Manufacturers, Food                         used for the               Rita in August and
                  Warehouse Managers, and                     decontamination of food    September 2005
                  Transporters of Food                        transport vehicles that
                  Products on                                 have been flooded or
                  Decontamination of                          otherwise impacted by
                  Transport Vehicles                          hurricanes, before being
                                                              placed back in service
                                                              to transport or store
                                                              food
----------------------------------------------------------------------------------------------------------------

[[Page 22719]]

 
2007 (Ref. 26)   Grade A Pasteurized Milk   Model standard   Sets forth training        To facilitate the
                  Ordinance, Appendix B,     for voluntary    requirements, evaluation   shipment and acceptance
                  Milk Sampling, Hauling     adoption by      criteria, and standards    of milk and milk
                  and Transportation         State and        to be met by bulk milk     products of high
                                             local            haulers and milk           sanitary quality in
                                             authorities      transporters               interstate and
                                                                                         intrastate commerce
----------------------------------------------------------------------------------------------------------------
2008 (Ref. 27)   Guidance for Industry:     Guidance         Recommends practices for   Part of recommendations
                  Guide to Minimize                           transporting fresh-cut     to enhance the safety
                  Microbial Food Safety                       produce under conditions   of fresh-cut produce by
                  Hazards of Fresh-Cut                        that will protect the      minimizing microbial
                  Fruits and Vegetables                       food against physical,     food safety hazards
                                                              chemical, and
                                                              microbiological
                                                              contamination
----------------------------------------------------------------------------------------------------------------
2008 (Sec.       Cattle Materials           Regulation       Requires the use of        To provide an additional
 589.2001(c);     Prohibited in Animal                        dedicated equipment for    layer of animal feed
 73 FR 22720;     Food or Feed to Prevent                     handling and               protections by removing
 April 25,        the Transmission of                         transporting cattle        that material at
 2008)            Bovine Spongiform                           materials prohibited in    highest risk for
                  Encephalopathy                              animal feed                transmitting BSE
                                                                                         through animal feed
----------------------------------------------------------------------------------------------------------------
2009 (21 CFR     Production, Storage, And   Regulation       Establishes requirements   Part of a rule requiring
 118.1(b) and     Transportation Of Shell                     for refrigeration of       measures to prevent
 118.4(e); 74     Eggs                                        shell eggs during          Salmonella Enteritidis
 FR 33030, July                                               transportation             in shell eggs during
 9, 2009)                                                                                production, storage,
                                                                                         and transportation
----------------------------------------------------------------------------------------------------------------
\*\ All section numbers cited in Table 1 refer to sections in 21 CFR.
\**\ We have requested comments and scientific data to enable us to improve this guidance (73 FR 51306,
  September 2, 2008).
\***\ If a treated juice is transported to another facility for final packaging or blending and packaging
  operations, the entire 5-log reduction must be repeated (66 FR 6138 at 6172, January 19, 2001).

F. Current Industry Practices and Areas Where Food Is At Greatest Risk 
For Contamination

1. Interstate Food Transportation Assessment Project
    In 2007, the Michigan Department of Agriculture released 
information obtained from its Interstate Food Transportation Assessment 
Project, conducted with the States of Michigan, Illinois, Indiana, and 
Ohio (Ref. 28). 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 that increase the likelihood of food contamination, 
such as improper refrigeration, transport of raw meat and poultry 
simultaneously or sequentially in trucks also used to carry fruit and 
vegetables, food products lacking label or source information, improper 
packaging, infestation with insects, insanitary storage (e.g., roof 
leaks and moldy walls, animal blood and food on bed floors), lack of 
security seals or locks, low driver awareness of safe food 
temperatures, and inadequate food safety training of drivers (Refs. 28 
and 29). Most of the specific instances where food transportation 
problems were found involved smaller box trucks and transporters of 
ethnic food; there were ``little or no areas of concern'' identified 
with larger (semi-tractor trailer) trucks inspected during the survey 
(Ref. 28).
2. Report by Eastern Research Group, Inc.
    The data and information we received in response to the 1996 joint 
ANPRM are now dated. To obtain more current data and information, we 
recently contracted with Eastern Research Group, Inc. (ERG) to 
undertake a study designed 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. 29). In 2009, ERG 
issued a report (the ERG report) with its findings (Ref. 29). The ERG 
report describes the results of a comprehensive literature review 
pertaining to food handling practices in the food transportation 
industry. The ERG report also presents the findings from an expert 
opinion elicitation study, which ERG conducted to identify the main 
problems that pose microbiological, chemical, and/or physical safety 
hazards to food during transportation and storage, and to determine the 
preventive controls needed to address each of the problems identified. 
The ERG report largely discusses its findings from the perspective of 
food intended for consumption by humans (e.g., raw seafood, meat, 
poultry, produce, eggs, and refrigerated foods that are ready-to-eat) 
but also reports some findings related to animal feed.
    In its report, ERG provides an overview of the domestic food supply 
chain (Ref. 29). A manufacturing facility may be served by a tier of 
suppliers. These manufacturing facilities then serve distribution 
facilities, which eventually serve retailer outlets, including 
restaurant retail facilities that serve the end consumer. Some food 
manufacturers use third-party logistics providers to outsource 
transportation procurement, while others organize the transport of 
their goods internally. (A third-party logistics provider is a firm 
that provides outsourced or ``third party'' logistics services to 
companies for part or sometimes all of their supply chain management 
function.) In this complex system, risk associated with an undetected 
problem increases the further one moves back in the supply chain, 
because a problem that is introduced further back in the supply chain 
system can spread out to many distributors and retailers who serve 
consumers.
    Through its literature review, ERG identified:
     Existing food transportation guidelines prepared by 
Federal agencies, foreign countries, international organizations, and 
trade associations;
     Three types of potential contamination that could arise 
during

[[Page 22720]]

transportation and storage (i.e., physical, chemical, and biological 
contamination) and risk factors during transportation and holding; and
     Best practices for food transportation and holding (i.e., 
temperature control, increased security and tracking, proper loading/
unloading practices, monitoring and ensuring the sanitation and 
condition of transportation vehicles, good communication, employee 
awareness and training, and pest control programs).
    Through its literature review and expert opinion elicitation study, 
ERG identified the following 15 problem 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). This may be intentional (abuse or 
violation of practices by drivers, i.e., turning off refrigeration 
units) or unintentional (due, for example, to improper holding 
practices or shortages of appropriate shipping containers or vessels).
     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;
     Lack of security for transportation units or storage 
facilities, including lack of or improper use of security seals and 
lack of security checks or records of transporters;
     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;
     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; and
     Lack of traceability for food products during 
transportation and storage.
    Through its literature review and expert opinion elicitation study, 
ERG identified the following seven preventive controls with the 
broadest applicability across all food sectors and modes of transport:
     Employee awareness and training;
     Management review of records;
     Good communication between shipper, transporter, and 
receiver;
     Appropriate loading procedures for transportation units;
     Appropriate unloading procedures for transportation units;
     Appropriate documentation accompanying each load (e.g., 
tanker wash record, seal numbers, temperature readings, time in-
transit, and time on docks); and
     Appropriate packaging/packing of food products and 
transportation units (e.g., good quality pallets, correct use of 
packing materials).

II. Issues and Requests for Data and Information

    As already noted, the data and information received in response to 
the 1996 joint ANPRM are dated and are of limited usefulness. The more 
recent data and information in the ERG report enhances our 
understanding of current baseline practices in the food transportation 
industry, problem areas that pose microbiological, chemical, and/or 
physical safety hazards to food during transportation and storage, and 
preventive controls that have the potential to address the problem 
areas.
    The purpose of this document is to obtain data and information that 
would be more current and of greater relevance than the data and 
information we received in response to the 1996 joint ANPRM and to 
augment the more current information in the ERG report. Specifically, 
we request public comments containing data and information on the 
issues and questions listed in sections II.A through II.G of this 
document.

A. Issue 1: Firms Subject to the 2005 SFTA

    We are seeking data and information about firms that are subject to 
the 2005 SFTA and the food for humans or animals that such firms 
transport. Firms subject to the 2005 SFTA include shippers, carriers by 
motor vehicle or rail vehicle, receivers, and any other person engaged 
in the transportation of food. These data and information will enhance 
our understanding of the characteristics of the firms that are 
providing food transportation services.
    Question 1a. What types of vehicles or methods are used to 
transport food by motor vehicle or rail vehicle (e.g., bulk tank 
trucks, cargo tanks, and freight containers)?
    Question 1b. How much food, and what percentage of food, is carried 
by each type of vehicle on an annual basis?
    Question 1c. What are the amounts and percentages of foods that are 
transported completely enclosed by packaging, not completely enclosed 
by packaging (e.g., grain, some fresh produce items), or in bulk tanks 
(e.g., juices, oils)?
    Question 1d. What proportion of vehicles is exclusively dedicated 
to transporting foods? What proportion of vehicles transport both food 
and nonfood products?

B. Issues 2 through 6: Current Practices Used By Firms Subject to the 
2005 SFTA

    We are seeking data or information on the specific sanitary 
transportation practices that must be prescribed under regulations we 
establish under section 416(c)(1) of the act.
1. Issue 2: Sanitation Practices
    Question 2a. What industry standards exist for the cleaning of food 
transportation vehicles?
    Question 2b. How are appropriate protocols established for cleaning 
vehicles (including bulk vehicles and nonbulk vehicles)?
    Question 2c. How is the adequacy of cleaning vehicles (including 
bulk vehicles and nonbulk vehicles) assessed?
2. Issue 3: Packaging, Isolation, and Other Protective Measures
    Question 3a. What procedures and practices are in place to prevent 
contamination of foods not completely enclosed by packaging during 
transport?
    Question 3b. How are the physical integrity and physical security 
of a food

[[Page 22721]]

transport vehicle ensured during its run?
    Question 3c. What operations associated with food transport (e.g., 
intermodal transfer and pumping food from transport tanks into 
receiving vessels at the destination) pose the greatest potential for 
contaminating food?
    Question 3d. What procedures and practices are in place to ensure 
temperature control for TCS foods?
3. Issue 4: Limitations on the Use of Vehicles
    Question 4a. What types of food products are typically transported 
simultaneously? What types of food products are typically transported 
sequentially?
    Question 4b. Are there any industry standards or State or local 
restrictions on the simultaneous or sequential transport of different 
categories of food?
4. Issue 5: Information Sharing Among Parties Involved in the 
Transportation of Food
    Through the 2005 SFTA, Congress provided express authority to 
specify the types of information that must be disclosed to carriers by 
persons arranging to transport food and to manufacturers or other 
persons that arrange for the transport of food or furnish a vehicle for 
the transportation of food. In our exercise of this authority, it is 
critical that we understand what sort of information exchange is 
feasible, practical, and/or desirable.
    Question 5a. What types of information are currently disclosed to 
carriers by persons arranging to transport food? In what form is this 
information disclosed? What additional information would be useful or 
necessary to achieve the goals of the 2005 SFTA?
    Question 5b. What types of information are currently disclosed to 
manufacturers or other persons that arrange for the transport of food 
by a carrier? In what form is this information disclosed? What 
additional information would be useful or necessary to achieve the 
goals of the 2005 SFTA?
    Question 5c. What types of information are currently disclosed to 
manufacturers or other persons that furnish a tank vehicle or bulk 
vehicle for the transportation of food? In what form is this 
information disclosed? What additional information would be useful or 
necessary to achieve the goals of the 2005 SFTA?
5. Issue 6. Records Currently Kept By Firms Subject to the 2005 SFTA
    Question 6a. What types of records are currently kept by persons 
arranging to transport food? What additional records would be useful or 
necessary to achieve the goals of the 2005 SFTA? How long should 
persons arranging to transport food keep applicable records?
    Question 6b. What types of information are currently kept by 
shippers and by carriers by motor vehicle or rail vehicle? What 
additional records would be useful or necessary to achieve the goals of 
the 2005 SFTA? How long should shippers and carriers by motor vehicle 
or rail vehicle keep applicable records?
    Question 6c. What types of records are currently kept by receivers 
of food? What additional records would be useful or necessary to 
achieve the goals of the 2005 SFTA? How long should persons who receive 
food keep applicable records?

C. Issue 7. Simultaneous or Subsequent Shipment of Nonfood Products in 
Vehicles Used to Transport Food

    Question 7a. Are food products transported simultaneously or 
sequentially with nonfood products? If the answer to this question is 
yes, what nonfood products are commonly transported in vehicles that 
also transport food?
    Question 7b. What nonfood products may, if shipped in a bulk 
vehicle, pose a risk of contamination to food that is subsequently 
transported in the same vehicle?
    Question 7c. What nonfood products may, if shipped in a motor 
vehicle or rail vehicle (other than a tank vehicle or bulk vehicle), 
pose a risk of contamination to food that is simultaneously or 
subsequently transported in the same vehicle?
    Question 7d. Are there any industry standards or State or local 
restrictions on the simultaneous or sequential transport of food and 
nonfood products?

D. Issue 8. Acceptable Reasons for Waiver of Requirements

    Question 8. What reasons might exist for a waiver of any or all 
foreseeable requirements under section 416 with respect to any class of 
persons, vehicles, food, or nonfood products? For any such reason for 
waiver, identify and provide data and information that would support a 
possible determination that the waiver (A) will not result in the 
transportation of food under conditions that would be unsafe for human 
or animal health; and (B) will not be contrary to the public interest.

E. Issue 9. Federal Preemption of State and Local Food Transportation 
Requirements

    Section 416(e) of the act, as amended by the 2005 SFTA, states that 
a requirement of a State or political subdivision of a State that 
concerns the transportation of food is preempted if it conflicts with 
or presents an obstacle to implementing the requirements of this 
section or a regulation prescribed under this section. FDA is seeking 
comments on existing requirements of a State or political subdivision 
of a State regarding the sanitary transportation of food. FDA intends 
to solicit further comments regarding this provision in the proposed 
rule.
    Question 9. What States or political subdivisions of a State have 
requirements for the sanitary transportation of food and what are these 
requirements?

F. Issue 10. Risk for Foodborne Illness Associated With Transportation 
of Food

    We have limited data and information about outbreaks of foodborne 
illness associated with transportation of food; see sections I.A and 
I.F of this document for a description of the data and information 
currently available to us. There are, however, a number of known areas 
where food is at risk for adulteration and reported instances of unsafe 
food transport (Refs. 10, 28, and 29). We are seeking data and 
information to enable us to focus our regulatory efforts in areas that 
present the greatest risk to public health.
    Question 10a. What data or information are available on 
investigations that have shown a suspected or documented link between 
an outbreak of foodborne illness and the transport process?
    Question 10b. What data or information are available in instances 
where food was suspected or documented of being contaminated during 
transport, even if the food was not implicated in an outbreak of 
foodborne illness?
    Question 10c. What data or information are available from State or 
local authorities regarding compliance with or enforcement of State or 
local food transportation requirements?
    Question 10d. What are the problem areas where food may be at 
greatest risk for physical, chemical, or biological contamination 
during transport?

G. Issue 11. Benefits and Costs

    We are seeking data and information to enable us to estimate the 
benefits and costs of regulations implementing the 2005 SFTA and to 
estimate of the effects of regulatory options on small entities.

[[Page 22722]]

    Question 11a. What is the size of carrier firms (e.g., based on 
annual revenue or on number of vehicles)?
    Question 11b. What is the number of small entities that could be 
affected by regulations implementing the 2005 SFTA?
    Question 11c. What steps could be taken to lessen the burden on 
small entities while still protecting the public health?

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

IV. References

    We have placed the following references on display in the Division 
of Dockets Management (see ADDRESSES). You may see them between 9 a.m. 
and 4 p.m., Monday through Friday. (FDA has verified the Web site 
addresses, but FDA is not responsible for any subsequent changes to the 
Web sites after this document publishes in the Federal Register.)
    1. FDA, 2005, CPG Sec. 565.100 FDA Jurisdiction Over Meat and 
Poultry Products. Available at https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074588.htm. 
Accessed and printed on February 18, 2010.
    2. FSIS, 2005, FSIS Safety and Security Guidelines for the 
Transportation and Distribution of Meat, Poultry, and Egg Products. 
Accessed and printed on March 31, 2010.
    3. Food Safety Working Group, 2009, Key Findings, Available at 
https://www.foodsafetyworkinggroup.gov/ContentKeyFindings/HomeKeyFindings.htm. Accessed and printed on January 22, 2010.
    4. FDA, 1982, FDA Notice of Jud