[Federal Register: April 30, 2010 (Volume 75, Number 83)]
[Proposed Rules]
[Page 22713-22723]
[DOCID:fr30ap10-17]

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

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:<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.
    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,<PHONE_NUMBER>.

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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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).

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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.''
---------------------------------------------------------------------------

     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.
---------------------------------------------------------------------------

    \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.''
---------------------------------------------------------------------------

    [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.

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
----------------------------------------------------------------------------------------------------------------
     Year &
   Reference*              Title                  Type              Description               Circumstances
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

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.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

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

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

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.

    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.

HHSF223200730236G, ERG Task No. 0<IP_ADDRESS>.

    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


[Federal Register Volume 77, Number 13 (Friday, January 20, 2012)]
[Notices]
[Page 3030]
[FR Doc No: 2012-1048]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Twenty-Eighth Meeting: RTCA Special Committee 206: Aeronautical
Information and Meteorological Data Link Services

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Notice of RTCA Special Committee 206: Aeronautical Information
and Meteorological Data Link Services.

-----------------------------------------------------------------------

SUMMARY: The FAA is issuing this notice to advise the public of the
twenty-eighth meeting of RTCA Special Committee 206: Aeronautical
Information and Meteorological Data Link Services

DATES: The meeting will be held February 6-10, 2012, from 8 a.m.-5 p.m.

ADDRESSES: The meeting will be held at the Doubletree Suites by Hilton
Melbourne Beach Oceanfront, 1665 N. Highway A1A, Melbourne, Florida
32903

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC, 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a) (2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 206, Aeronautical
Information and Meteorological data Link Services. The agenda will
include the following:

February 6, 2012

 Welcome, Introductions, and Administrative Remarks
 Approval of Previous Meeting Minutes
 Review and approve meeting agenda
 Introduce advisory and normal definitions
 Review proposed TOR changes
 ConUse Review

February 7, 2012

 ConUse Review

February 8, 2012

 SG1, SG2, and SG3 Meetings

February 9, 2012

 SG1, SG2, and SG3 Meetings

February 10, 2012

 Plenary Session
 Sub-Group 1 Report
 Sub-Group 2 Report
 Sub-Group 3 Report
 Action item review
 Future meeting plans and dates
 Plenary presentation selection process
 Approve advisory and normal definitions
 Approve proposed TOR changes and new or modified Sub-groups'
roles and responsibilities
 Decision to release ConUse document for FRAC process
 Other business
 Adjourn

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on January 12, 2012.
John Raper,
Manager, Business Operations Branch, Federal Aviation Administration.
[FR Doc. 2012-1048 Filed 1-19-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 19 (Monday, January 30, 2023)]
[Notices]
[Pages 5876-5877]
[FR Doc No: 2023-01784]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OLEM-2018-0317; FRL-10627-01-OMS]

Agency Information Collection Activities; Submission to the
Office of Management and Budget for Review and Approval; Comment
Request; Criteria for Classification of Solid Waste Disposal Facilities
and Practices (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Criteria for Classification of
Solid Waste Disposal Facilities and Practices, Recordkeeping and
Reporting Requirements (EPA ICR Number 1745.10, OMB Control Number
2050-0154) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. This is a
proposed extension of the ICR, which is currently approved through
February 28, 2023. Public comments were previously requested, via the
Federal Register, on July 5, 2022 during a 60-day comment period. This
notice allows for an additional 30 days for public comments.

DATES: Comments may be submitted on or before March 1, 2023.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OLEM-
2018-0317, to EPA online using www.regulations.gov (our preferred
method), or by mail to: RCRA Docket (2822T), U.S. Environmental
Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Richard Huggins, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION: This is a proposed extension of the ICR,
which is currently approved through February 28, 2023. An agency may
not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.
    Public comments were previously requested via the Federal Register
(87 FR 39830) on July 5, 2022 during a 60-day comment period. This
notice allows for an additional 30 days for public comments. Supporting
documents, which explain in detail the information that the EPA will be
collecting, are available in the public docket for this ICR. The docket
can be viewed online at www.regulations.gov. Materials can

also be viewed at the Reading Room located at the EPA Docket Center,
WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington,
DC 20004. The Docket Center's hours of operations are 8:30 a.m.-4:30
p.m., Monday-Friday (except Federal Holidays). The telephone number for
the Docket Center is<PHONE_NUMBER>.
    Abstract: In order to effectively implement and enforce final
changes to 40 CFR part 257--subpart B on a State level, owners/
operators of construction and demolition waste landfills that receive
CESQG hazardous wastes will have to comply with the final reporting and
recordkeeping requirements. This continuing ICR documents the
recordkeeping and reporting burdens associated with the location and
ground-water monitoring provisions contained in 40 CFR part 257--
subpart B.
    Form numbers: None.
    Respondents/affected entities: Entities potentially affected by
this action are the private sector, as well as State, Local, or Tribal
Governments.
    Respondent's obligation to respond: Mandatory under Section
4010(copyright) and 3001(d)(4) of the Resource Conservation and
Recovery Act (RCRA) of 1976.
    Estimated number of respondents: 152.
    Frequency of response: On occasion.
    Total estimated burden: 11,219 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $1,951,843 per year, which includes
$1,577,659 annualized capital or operation & maintenance costs.
    Changes in the estimates: There is no change in the number of hours
in the total estimated respondent burden compared with the ICR
currently approved by OMB.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2023-01784 Filed 1-27-23; 8:45 am]
BILLING CODE 6560-50-P


HES2D: SHEDS and ERDEM March 3, 2003 The Human Exposure Source to Dose Modeling ( HES2D) framework houses a number of exposure and dose models including SHEDS and ERDEM. The Stochastic Human Exposure and Dose Simulation ( SHEDS) modeling system is being developed for analyzing multimedia multipathway exposures of both the general and sensitive subpopulations, such as children and the elderly. The Exposure Related Dose Evaluation Model ( ERDEM)

Purpose: HES2D was designed to provide a scientifically robust, complete multimedia, multipathway modeling framework that can 1) estimate exposures and doses to both the general population and to identifiable susceptible subpopulations, and 2) predict and diagnose the complex relationships between source and exposure and dose. The modeling framework software and its various components and modules and other analytical tools will assist researchers engaged in the development, refinement, and interpretation of human exposure modeling techniques. In addition, the tools in HES2D will provide the risk assessment community with a set of useful modeling software packages to enable multimedia, multipathway exposures to be estimated  with explicitly quantified variability and uncertainty  for a wide variety of subpopulations and environmental contaminants. This capability will also provide EPA Program Offices with analytical software tools and algorithms to support the prioritization of pollutants and pollutant source categories in support of future mitigation strategies to evaluate human exposure and risk implications of pollutants in air, soil, food and water.

The Stochastic Human Exposure Dose Modeling System ( SHEDS) models have been developed to assess exposure to pesticides and particulate matter ( PM) and when considered collectively provide estimates of exposures through four routes of exposure: inhalation, dermal absorption, dietary ingestion, and non dietary ingestion. SHEDS is a physically based, probabilistic computer model that predicts, for user specified cohorts, exposures and doses incurred via eating contaminated foods or drinking water, inhaling contaminated air, touching contaminated surface residues, and ingesting residues from hand or object to mouth activities. To do this, it combines information on pesticide usage, human activity data ( from time/ activity diary surveys and videography studies), environmental residues and concentrations, exposure and dose factors using 1 stage or 2 stage Monte Carlo probabilistic sampling methods.

ERDEM is a modeling system that allows the development of physiologically based pharmacokinetic models for any chemical of interest. Exposure inputs are multimedia and multipathway in nature. To date the system has been applied to several pesticides, trichloroethylene and other chlorinated solvents and by products found in drinking water and air, MTBE. Current work is on extending the applications for carbamates and pyrethroid pesticides. ERDEM can examine scenario based aggregate exposure along several pathways ( e. g., dermal transfer from surfaces, inhalation within micro environments, and ingestion of food as well as extraneous matter via hand to mouth activity) as simultaneous inputs to internal dose from several routes ( e. g., dermal absorption, oral, and respiratory) as a means to assess cumulative risk.

Status: Work began in October 1, 1998 and will continue through September 30, 2003. To date, research has focused on the development of the conceptual components for a source to dose human exposure modeling framework and software system. Initial testing has been done on the framework for exposures and dosimetry using the Stochastic Human Exposure and Dose System ( SHEDS) models. Significant progress has been made in the development and refinement of important framework components such as an improved understanding of phase, spatial, and temporal distributional characteristics for various pollutants of interest and the prediction of variability and uncertainty in modeling outputs. Critical inputs to the SHEDS and ERDEM models, such as the Consolidated Human Activity Database ( CHAD) or the Human Exposure Database System ( HEDS) are being linked to HES2d.

Contact: Eric Hall ( 919) 541 3147?

Short term Followup: Discuss with HES2D, SHEDS, and ERDEM staff the status of the framework and the models to determine ways to utilize them as a screening level tool for identifying national level concerns or trends in human health and the environment.

Long term Followup: Discuss with HES2D, SHEDS, and ERDEM staff the possibility of using these tools for in depth evaluation of the stressors identified in the short term ( and their possible sources) to support the more detailed investigation phase of the 304( m) planning process.


[Federal Register: October 26, 2007 (Volume 72, Number 207)]
[Notices]
[Page 60839-60840]
[DOCID:fr26oc07-57]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12842-000]

FFP Project 19, LLC; Notice of Application Accepted for Filing
and Soliciting Motions To Intervene, Protests, and Comments

October 18, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12842-000.
    c. Date filed: July 25, 2007.
    d. Applicant: FFP Project 19, LLC.
    e. Name of Project: Brilliant Point Project.
    f. Location: The project would be located on the Mississippi River
in St James Parish, Louisiana. The project uses no dam or impoundment.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)--825(r).
    h. Applicant Contact: Mr. Dan Irvin, FFP Project 19, LLC, 69 Bridge
Street, Manchester, MA 01944, phone<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-12842-000) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project consists of: (1)
2,600 proposed 20 kilowatt Free Flow generating units having a total
installed capacity of 56 megawatts, (2) a proposed transmission line;
and (3) appurtenant facilities. The FFP Project 19, LLC, project would
have an average annual generation of 227.76 gigawatt-hours and be sold
to a local utility.
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street NE., Room 2A,
Washington DC 20426, or by calling<PHONE_NUMBER>. This filing may also
be viewed on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the

document. For assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    o. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    p. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001 (a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``COMPETING
APPLICATION'', ``RECOMMENDATIONS FOR TERMS AND CONDITIONS'',
``PROTEST'', OR ``MOTION TO INTERVENE'', as applicable, and the Project
Number of the particular application to which the filing refers. Any of
the above-named documents must be filed by providing the original and
the number of copies provided by the Commission's regulations to: The
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    t. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-21156 Filed 10-25-07; 8:45 am]

BILLING CODE 6717-01-P