[Federal Register: April 30, 2010 (Volume 75, Number 83)]
[Proposed Rules]
[Page 22713-22723]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap10-17]
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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: http://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 http://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 http://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)]
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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
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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
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[[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
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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
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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
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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
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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
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[[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
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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
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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 http://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
http://www.foodsafetyworkinggroup.gov/ContentKeyFindings/
HomeKeyFindings.htm. Accessed and printed on January 22, 2010.
4. FDA, 1982, FDA Notice of Judgment No. 31, FDA Consumer, Vol.
16, No. 7, pp. 33-34.
5. FDA, 1975, Memorandum dated June 9, 1975, from Bureau of
Veterinary Medicine to General Counsel regarding 026-137G, Doc 096-
447H, Corn Gluten Meal, Veterinary.
6. Schneider, K., 1989, ``Tainted Milk and Meat Raise
Vigilance,'' New York Times, May 11, 1989, Available at http://
www.nytimes.com/1989/05/11/us/tainted-milk-and-meat-raise-
vigilance.html, Accessed and printed on July 24, 2009.
7. FDA, 1989, Memorandum dated November 15, 1989, from Case
Guidance Branch, Division of Compliance, Center for Veterinary
Medicine to New Orleans District Office Regarding Barium Carbonate
Contamination, EIR 5/8-25/89, 89-559-371/382, Feeds and Ingredients.
8. U.S. Government Accounting Office, 1990, Report to
Congressional Requesters, Truck Transport: Little is Known About
Hauling Garbage and Food in the Same Vehicles, GAO/RCED-90-161,
Available at http://archive.gao.gov/d23t8/141739.pdf, Accessed and
printed on June 3, 2009.
9. Hennessy T.W., Hedberg, C.W., Slutsker, L. et al., 1996, ``A
National Outbreak of Salmonella Enteriditis Infections From Ice
Cream,'' New England Journal of Medicine, Vol. 334, No. 20, pp.
1281-1286.
10. Motor Carrier Division, Michigan State Police, 2007,
Commercial Motor Vehicle Enforcement Quarterly, Available at http://
www.michigan.gov/documents/msp/CMV_Quarterly_January_2007_
205099_7.pdf, Accessed and printed on May 28, 2009.
11. FDA, 2009, Recall of Products Containing Peanut Butter;
Salmonella Typhimurium, Printed February 4, 2009.
12. FDA, 2009, Safety, FDA's Investigation, (Peanut Products
Recall), Printed June 4, 2009.
13. Peanut Corporation of America, 2009, Press release, January
18, 2009, Available at http://www.fda.gov/Safety/Recalls/
ArchiveRecalls/2009/ucm128828.htm, Accessed and printed on June 2,
2009.
14. U.S. Department of Transportation, Office of Inspector
General, 1998, Audit Report, Review of Departmental Actions
Concerning the Sanitary Food Transportation Act of 1990, Research
and Special Programs Administration, TR-1998-100, Available at
http://www.oig.dot.gov/StreamFile?file=/data/pdfdocs/tr1998100.pdf,
Accessed and printed on June 3, 2009.
15. FDA, 2009, Food Code, Chapter 1, Purpose and Definitions,
Available at http://www.fda.gov/Food/FoodSafety/
RetailFoodProtection/FoodCode/FoodCode2009/ucm186464.htm, Accessed
and printed on November 24, 2009.
16. FDA, 2003, Guidance on Bulk Transport of Juice Concentrates
and Certain Shelf Stable Juices, Available at http://www.fda.gov/
Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
default.htm, Accessed and printed on June 4, 2009.
17. FDA, 2007, Dairy Farms, Bulk Milk Transporters, Bulk Milk
Transfer Stations and Fluid Milk Processors: Food Security
Preventive Measures Guidance, Available at http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
default.htm, Accessed and printed on June 4, 2009.
18. FDA, 2007, Food Producers, Processors, and Transporters:
Food Security Preventive Measures Guidance, Available at http://
www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/
GuidanceDocuments/default.htm, Accessed and printed on June 4, 2009.
19. FDA, 1998, FDA Guidance for Industry 68, Small
Entities Compliance Guide for Protein Blenders, Feed Manufacturers,
and Distributors, Available at http://www.fda.gov/downloads/
AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/
UCM052382.pdf, Accessed and printed on August 4, 2009.
20. FDA, 1998, Guide to Minimize Microbial Food Safety Hazards
for Fresh Fruits and Vegetables, Available at http://www.fda.gov/
Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
default.htm, Accessed and printed on June 4, 2009.
21. The White House, Office of the Press Secretary, 1997,
President Clinton Announces Initiative to Ensure the Safety of
Imported and Domestic Fruits and Vegetables, Available at http://
clinton4.nara.gov/textonly/WH/New/html/19971002-8886.html, Accessed
and printed on November 30, 2009.
22. FDA, 2003, Guidance for Industry: Juice HACCP; Small Entity
Compliance Guide, Available at http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
default.htm, Accessed and printed on September 23, 2009.
23. FDA, 2004, Guidance for Industry 122, Manufacture
and Labeling of Raw Meat Foods for Companion and Captive
Noncompanion Carnivores and Omnivores, Available at http://
www.fda.gov/downloads/AnimalVeterinary/
GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052662.pdf,
Accessed and printed on August 4, 2009.
24. FDA, 2004, What You Need to Know About Establishment and
Maintenance of Records, Available at http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
default.htm, Accessed and printed on September 23, 2009.
25. FDA, 2006, A Notice from FDA to Growers, Food Manufacturers,
Food Warehouse Managers, and Transporters of Food Products on
Decontamination of Transport Vehicles, Available at http://
www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/
GuidanceDocuments/default.htm, Accessed and printed on November 30,
2009.
26. Grade A Pasteurized Milk Ordinance, Appendix B--Milk
Sampling, Hauling and Transportation, Available at http://
www.fda.gov/Food/FoodSafety/Product-SpecificInformation/MilkSafety/
NationalConferenceonInterstateMilkShipmentsNCIMSModelDocuments/
PasteurizedMilkOrdinance2007/ucm064241.htm, Accessed and printed on
July 13, 2009.
27. FDA, 2008, Guidance for Industry: Guide to Minimize
Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables,
Available at http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
default.htm, Accessed and printed on January 20, 2010.
28. Wojtala, G., 2007, Interstate Food Transportation Assessment
Project. Presented at the June 16 through 20, 2007, Conference of
the Association of Food and Drug Officials, Available at http://
www.michigan.gov/documents/mda/truckproj_224450_7.pdf, Accessed
and printed on May 28, 2009.
29. Eastern Research Group, Inc., 2009, Characteristics of
Current Food Transportation and Holding Practices for Food
Commodities, GSA MOBIS SIN 874-1, Contract No. GS-10F-0125P, Order
No.
[[Page 22723]]
HHSF223200730236G, ERG Task No. 0193.16.001.001.
Dated: April 26, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10078 Filed 4-29-10; 8:45 am]
BILLING CODE 4160-01-S