ensure that food is not transported under conditions that may render
the food adulterated.
    Based upon comments we received in response to the 2010 ANPRM, we
understand that in accordance with best industry practices, pre-loading
verification by shippers of the pre-cooling of refrigerated vehicles
and containers is commonly carried out in transportation operations
(although we understand that during such a verification check, the
refrigeration system may be turned off when its doors are open, e.g.,
in humid conditions, to prevent water condensation on surfaces such as
fiberboard packages that could be damaged by the water). Accordingly,
we do not believe that the requirement placed on the shipper by
proposed Sec.  1.908(b)(4) would require substantial efforts beyond
those which are already common within the food transportation industry.
    Proposed Sec.  1.908(b)(5) would provide that the shipper assumes
the requirements applicable to the carrier in proposed Sec.
1.908(d)(2)(i) (discussed later in this section) with respect to
providing a demonstration to the receiver, if the shipper and carrier
have agreed in writing pursuant to proposed Sec.  1.908(d)(2)(ii) (also
discussed later in this section) that the shipper is responsible for
ensuring that the food was held under acceptable temperature conditions
during transportation operations. Proposed Sec.  1.908(b)(5) would also
provide that the shipper assumes the corresponding records requirements
applicable to the carrier under proposed Sec.  1.908(d)(6)(ii) and
proposed Sec.  1.912(c) (also discussed later in this section).
    We refer the reader to the discussion in this section of the
requirement in proposed Sec.  1.908(d)(2)(i) that the carrier
demonstrate to the shipper and, if requested, to the receiver, that it
has maintained temperature conditions during the transportation
operation consistent with those specified by the shipper. Proposed
Sec.  1.908(d)(2)(ii) would discharge the carrier from this requirement
if the carrier and shipper agree, in writing and before transportation
operations, that the shipper is responsible for monitoring the
temperature conditions or otherwise assuring that the food was held
under acceptable temperature conditions during the transportation
operation.
    In the circumstance addressed by proposed Sec.  1.908(d)(2)(ii),
e.g., a shipment by refrigerated rail car wherein the shipper controls
the operation of the refrigeration equipment in a leased rail car,
inasmuch as the shipper would be assuming responsibilities otherwise
assigned to the carrier under this proposed rule, proposed Sec.
1.908(b)(5) would make it clear that the shipper is also required to
provide to the receiver, if requested, the specified demonstration that
would have otherwise been provided by the carrier. Proposed Sec.
1.908(b)(5) also makes it clear that the shipper assumes the
corresponding records requirements that would otherwise be applicable
to the carrier under proposed Sec. Sec.  1.908(d)(6)(ii) and proposed
Sec.  1.912(b). Proposed Sec.  1.908(b)(5) thus would ensure that the
shipper is subject to the same requirements to provide information to
the receiver, and the same corresponding records requirements as the
carrier would otherwise be, in circumstances where the shipper has
assumed a responsibility that would otherwise be borne by the carrier.
3. Requirements Applicable to Shippers and Receivers
    Proposed Sec.  1.908(c) would set forth requirements applicable to
both shippers and receivers engaged in transportation operations.

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

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

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

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

F. Training (Proposed Sec.  1.910)

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

G. Records (Proposed Sec.  1.912)

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

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

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

1. Statutory Authority
    Section 416(d) of the FD&C Act provides the Secretary with the
authority to waive any requirement under section 416 of the FD&C Act,
which would include the requirements of this proposed rule, with
respect to any class of persons, vehicles, food, or nonfood products,
if the Secretary determines that the waiver will not result in the
transportation of food under conditions that would be unsafe for human
and animal health and will not be contrary to the public interest.
Section 416(d)(2) of the FD&C Act further provides that the Secretary
shall publish in the Federal Register any waiver and the reasons for
the waiver. Aside from section 416(d)(2), section 416 does not
expressly prescribe the procedures for granting a waiver under section
416(d) or for revoking or amending a waiver that has already been
granted under section 416(d).
2. Proposed Requirements
    Consistent with the statutory provisions mentioned previously, we
are proposing a process by which FDA will grant waivers from one or
more requirements of subpart O on its own initiative or in response to
a petition from an interested person, including information that must
accompany such petitions, and the procedures and circumstances under
which FDA may grant or deny such petitions, and modify or revoke any
waivers that have already been granted. Waivers granted by FDA would be
limited to the requirements of subpart O specified by FDA in the
Federal Register notice announcing the waiver, and would have no effect
on the application of other provisions of the FD&C Act or FDA
regulations.
    Proposed Sec.  1.914 would provide that FDA may waive a requirement
of subpart O with respect to any class of persons, vehicles, food, or
nonfood products, if FDA determines that the waiver will not result in
the transportation of food under conditions that would be unsafe for
human or animal health and the waiver will not be contrary to the
public interest. This proposed provision is identical to the standard
set forth in section 416(d)(1) of the FD&C Act. Under this standard, a
waiver could be granted with regard to a specific requirement or subset
of requirements of subpart O or with regard to all requirements set
forth in subpart O. Similarly, under this standard, a waiver could be
granted with regard to any class of persons, vehicles, food, and/or
nonfood products and the transportation operations in which they
engage.
    Proposed Sec.  1.916 would provide that FDA will consider whether
to waive a requirement of subpart O on FDA's own initiative or on the
petition submitted under Sec.  10.30 (21 CFR 10.30) by any person who
is subject to the requirements of subpart O with respect to any class
of persons, vehicles, food, or nonfood products. FDA would welcome
requests for pre-petition consultations, including meetings, with
interested persons to facilitate the development of petitions seeking a
waiver of some or all of the requirements of subpart O, including data
and information necessary to demonstrate that the waiver will not
result in the transportation of food under conditions that would be
unsafe for human or animal health and that the waiver will not be
contrary to the public interest.
    Proposed Sec.  1.918 would provide that, in addition to the
requirements set forth in Sec.  10.30, the Statement of Grounds (which
is addressed under Sec.  10.30(b)) of a petition requesting a waiver
must describe with particularity the waiver requested, including the
persons, vehicles, food, or nonfood product(s) to which the waiver
would apply and the requirement(s) of subpart O to which the waiver
would apply (proposed Sec.  1.918(a)). In addition, the Statement of
Grounds would also be required to present information demonstrating
that the waiver will not result in the transportation of food under
conditions that would be unsafe for human or animal health and will not
be contrary to the public interest (proposed Sec.  1.918(b)). Under
these provisions, an interested person would be required to submit
relevant and scientifically-valid information or materials specific to
the requested waiver to demonstrate that the waiver will not result in
the transportation of food under conditions that would be unsafe for
human or animal health and will not be contrary to the public interest.
This could include information about the nature of the food, the manner
in which it is transported, the controls in place to mitigate any food
safety issues, and government and/or non-government oversight of the
transportation of the food.
    Proposed Sec.  1.920 establishes our presumption that information
submitted in a petition requesting a waiver and comments submitted on
such a petition does not contain information exempt from public
disclosure under part 20 of this chapter and would be made public as
part of the docket associated with this request. We do not believe that

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

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

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

IV. Preliminary Regulatory Impact Analysis

A. Overview

    FDA has examined the impacts of this proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). We have developed a Preliminary Regulatory Impact Analysis
(PRIA) that presents the benefits and costs of this proposed rule (Ref.
33). We believe that the proposed rule will be a significant regulatory
action as defined by Executive Order 12866. We request comments on the
PRIA.
    The summary analysis of benefits and costs included in this
document is drawn from the detailed PRIA (Ref. 33) which is available
at http://www.regulations.gov (Docket No. FDA-2013-N-0013) and is also
available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

B. Regulatory Flexibility Act

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

C. Unfunded Mandates Reform Act of 1995

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2012) Implicit
Price Deflator for the Gross Domestic Product. FDA expects that this
proposed rule will result in a 1-year expenditure that would meet or
exceed this amount.
    The analyses that we have performed to examine the impacts of this
proposed rule under Executive Order 12866, Executive Order 13563, the
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of
1995 are available to the public in the docket for this proposed rule
(Ref. 33).

V. Paperwork Reduction Act of 1995

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

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

VI. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(j) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive Order requires agencies to ``construe . . . a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Federal law includes an express preemption
provision at section 416(e) of the FD&C Act, which provides that a
requirement of a State or political subdivision of a State that
concerns the transportation of food is preempted if: (1) Complying with
the requirement of the State or political subdivision and with a
requirement of section 416 of the FD&C Act, or with a regulation issued
under section 416 of the FD&C Act, is not possible; or (2) the
requirement of the State or political subdivision as applied or
enforced is an obstacle to accomplishing and carrying out section 416
of the FD&C Act or a regulation issued under section 416 of the FD&C
Act. Section 416(e) further provides that the express preemption
provision applies to transportation that occurs on or after the
effective date of regulations issued under section 416 of the FD&C Act.
This express preemption provision would apply to the requirements of
this proposed rule, when finalized.

VIII. Proposed Effective and Compliance Dates

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

IX. Request for Comments

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

X. References

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

1. Hennessy T.W., Hedberg, C.W., Slutsker, L. et al., 1996, ``A
National Outbreak of Salmonella Enteriditis Infections From Ice
Cream,'' New England Journal of Medicine, Vol. 334, No. 20, pp.
1281-1286, available at http://www.nejm.org/doi/full/10.1056/NEJM199605163342001#t=articleTop, accessed and printed on September
10, 2013.
2. FDA Memorandum, ``Feed RFRs Related to Transportation Problems,''
2012.
3. Wojtala, G., 2007, Interstate Food Transportation Assessment
Project, presented at the June 16 through 20, 2007, Conference of
the Association of Food and Drug Officials, available at http://www.michigan.gov/documents/mda/truckproj_224450_7.pdf, accessed
and printed on September 9, 2013.
4. Michigan Department of Agriculture, ``Food Truck Assessment
Project, April 18/19, 2006.''
5. The Indy Channel, ``200 Pounds of Contaminated Food Headed to
Central Indiana Restaurants in Semi Destroyed, Police: Raw Chicken,
Veggies Found Together,'' (http://www.theindychannel.com/news/local-news/200-pounds-of-contaminated-food-headed-to-central-indiana-restaurants-in-semi-destroyed), 2013, accessed and printed on
September 9, 2013.
6. Caledonia Record, ``DMV Stops Truck, Finds Spoiled Food,'' August
18, 2012.
7. Courier Journal, ``Overheated Transport Trucks Spark Concerns
About Spoilage,'' August 10, 2012.
8. Motor Carrier Division, Michigan State Police, ``Commercial Motor
Vehicle Enforcement Quarterly,'' (http://www.michigan.gov/documents/msp/CMV_Quarterly_January_2007_205099_7.pdf), 2007, accessed
and printed on September 9, 2013.
9. Eastern Research Group, Inc., 2009, Characteristics of Current
Food Transportation and Holding Practices for Food Commodities, GSA
MOBIS SIN 874-1, Contract No. GS-10F-0125P, Order
No.HHSF223200730236G, ERG Task No. 0<IP_ADDRESS>)
10. FDA, ``Guidance for Industry: Sanitary Transportation of Food,''
(http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/sanitationtransportation/ucm208199.htm), accessed and printed on January 28, 2014.
11. FSIS, ``FSIS Safety and Security Guidelines for the
Transportation and Distribution of Meat, Poultry, and Egg
Products,'' (http://www.fsis.usda.gov/shared/PDF/Transportation_Security_Guidelines.pdf), 2005, accessed and printed on September
9, 2013.

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

List of Subjects in 21 CFR Part 1

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

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 1 be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 is revised to read as
follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21
U.S.C. 321, 331, 333, 334, 335a, 343, 350c, 350d, 350e, 352, 355,
360b, 362, 371, 374, 381, 382, 387, 387a, 393; 42 U.S.C. 216, 241,
243, 262, 264.

0
2. Add subpart O, consisting of Sec. Sec.  1.900 through 1.934, to part
1 to read as follows:
Subpart O--Sanitary Transportation of Human and Animal Food

General Provisions

Sec.
1.900 Who is subject to this subpart?
1.902 How do the criteria and definitions in this subpart apply
under the Federal Food, Drug, and Cosmetic Act?
1.904 What definitions apply to this subpart?

Vehicles and Transportation Equipment

1.906 What requirements apply to vehicles and transportation
equipment?

Transportation Operations

1.908 What requirements apply to transportation operations?

Training

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

Records

1.912 What record retention and other records requirements apply to
shippers and carriers engaged in transportation operations?

Waivers

1.914 Under what circumstances will FDA waive a requirement of this
subpart?
1.916 When will FDA consider whether to waive a requirement of this
subpart?
1.918 What must be included in the Statement of Grounds in a
petition requesting a waiver?
1.920 What information submitted in a petition requesting a waiver
or submitted in comments on such a petition are publicly available?
1.922 Who will respond to a petition requesting a waiver?
1.924 What process applies to a petition requesting a waiver?
1.926 Under what circumstances may FDA deny a petition requesting a
waiver?
1.928 What process will FDA follow when waiving a requirement of
this subpart on FDA's own initiative?
1.930 When will a waiver granted by FDA become effective?
1.932 Under what circumstances may FDA modify or revoke a waiver?
1.934 What procedures apply if FDA determines that a waiver should
be modified or revoked?

Subpart O--Sanitary Transportation of Human and Animal Food

General Provisions

Sec.  1.900  Who is subject to this subpart?

    (a) Except for non-covered businesses as defined in Sec.  1.904,
the requirements of this subpart apply to shippers, receivers, and
carriers engaged in transportation operations whether or not the food
is being offered for or enters interstate commerce. The requirements of
this subpart apply in addition to any other requirements of this
chapter that are applicable to the transportation of food, e.g., in 21
CFR parts 1, 110, 118, 225, and 589).
    (b) The requirements of this subpart do not apply to shippers,
receivers, or carriers when they are engaged in transportation
operations of:
    (1) Food that is transshipped through the United States to another
country; or
    (2) Food that is imported for future export and that is neither
consumed nor distributed in the United States.

Sec.  1.902  How do the criteria and definitions in this subpart apply
under the Federal Food, Drug, and Cosmetic Act?

    (a) The criteria and definitions of this subpart apply in
determining whether food is adulterated within the meaning

of section 402(i) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 342(i)) in that the food has been transported or offered for
transport by a shipper, carrier by motor vehicle or rail vehicle, or
receiver engaged in transportation operations under conditions that are
not in compliance with this subpart.
    (b) The failure by a shipper, carrier by motor vehicle or rail
vehicle, or receiver engaged in transportation operations to comply
with the requirements of this subpart is a prohibited act under section
301(hh) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
331(hh)).

Sec.  1.904  What definitions apply to this subpart?

    The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) are applicable to
such terms when used in this part. The following definitions also
apply:
    Adequate means that which is needed to accomplish the intended
purpose in keeping with good public health practice.
    Animal food means food for animals other than man, and includes pet
food, animal feed, and raw materials and ingredients.
    Bulk vehicle means a tank truck, hopper truck, rail tank car,
hopper car, cargo tank, portable tank, freight container, or hopper
bin, or any other vehicle in which food is shipped in bulk, with the
food coming into direct contact with the vehicle.
    Carrier means a person who owns, leases, or is otherwise ultimately
responsible for the use of a motor vehicle or rail vehicle to transport
food. The carrier is responsible for all functions assigned to a
carrier in this subpart even if they are performed by other persons,
such as a driver that is employed or contracted by a trucking firm. A
carrier may also be a receiver or a shipper if the person also performs
the functions of those respective persons as defined in this subpart.
    Cross-contact means the unintentional incorporation of a food
allergen as defined in section 201(qq) of the Federal Food, Drug, and
Cosmetic Act into food, except animal food.
    Farm means a facility in one general physical location devoted to
the growing and harvesting of crops, the raising of animals (including
seafood), or both. The term ``farm'' includes facilities that pack or
hold food, regardless of whether all food used in such activities is
grown, raised, or consumed on that farm or another farm under the same
ownership.
    Food means food as defined in section 201(f) of the Federal Food,
Drug, and Cosmetic Act and includes raw materials and ingredients. Food
includes animal food and food also subject to the Federal Meat
Inspection Act, the Poultry Products Inspection Act, and the Egg
Products Inspection Act.
    Food not completely enclosed by a container means any food that is
placed into a container in such a manner that it is partially open to
the surrounding environment. Examples of such containers include an
open wooden basket or crate, an open cardboard box, a vented cardboard
box with a top, or a vented plastic bag. This term does not include
food transported in a bulk vehicle as defined in this subpart.
    Microorganisms means yeasts, molds, bacteria, viruses, protozoa,
and microscopic parasites and includes species having public health
significance. The term ``undesirable microorganisms'' includes those
microorganisms that are of public health significance, that subject
food to decomposition, that indicate that food is contaminated with
filth, or that otherwise may cause food to be adulterated.
    Non-covered business means a shipper, receiver, or carrier engaged
in transportation operations that has less than $500,000 in total
annual sales.
    Pest means any objectionable animals or insects including birds,
rodents, flies, and larvae.
    Receiver means any person who receives food after transportation,
whether or not that person represents the final point of receipt for
the food. A receiver may also be a carrier or a shipper if the person
also performs those functions as defined in this subpart. A receiver
does not include an individual consumer or a person who receives or
holds food on behalf of an individual consumer and who is not also a
party to the transaction and who is not in the business of distributing
food.
    Shelf stable food means a food that can be stored under ambient
temperature and humidity conditions and, if the package integrity is
maintained will not spoil or become unsafe throughout its storage life.
Examples of shelf stable food include canned juice, canned vegetables,
canned meat, bottled water and dry food items such as rice, pasta,
flour, sugar, and spices.
    Shipper means a person who initiates a shipment of food by motor
vehicle or rail vehicle. The shipper is responsible for all functions
assigned to a shipper in this subpart even if they are performed by
other persons, such as a person who only holds food and physically
transfers it onto a vehicle arranged for by the shipper. A shipper may
also be a carrier or a receiver if the shipper also performs those
functions as defined in this subpart.
    Small business means a business subject to Sec.  1.900(a) employing
fewer than 500 persons except that for carriers by motor vehicle that
are not also shippers and/or receivers, this term would mean a business
subject to Sec.  1.900(a) having less than $25,500,000 in annual
receipts.
    Time/temperature control for safety (TCS) Food means a food that
requires time/temperature control for safety to limit pathogenic
microorganism growth or toxin formation.
    Transportation means any movement of food in commerce by motor
vehicle or rail vehicle.
    Transportation equipment means equipment used in food
transportation operations, other than vehicles, e.g., bulk and non-bulk
containers, bins, totes, pallets, pumps, fittings, hoses, gaskets,
loading systems and unloading systems. Transportation equipment also
includes a railcar not attached to a locomotive or a trailer not
attached to a tractor.
    Transportation operations means all activities associated with food
transportation that may affect the sanitary condition of food including
cleaning, inspection, maintenance, loading and unloading, and operation
of vehicles and transportation equipment. Transportation operations do
not include any activities associated with the transportation solely of
shelf stable food that is completely enclosed by a container,
compressed food gases or live food animals. In addition, transportation
operations do not include any transportation activities for raw
agricultural commodities that are performed by a farm.
    Vehicle means a land conveyance that is motorized, e.g., a motor
vehicle, or that moves on rails, e.g., a railcar, which is used in
transportation operations.

Vehicles and Transportation Equipment

Sec.  1.906  What requirements apply to vehicles and transportation
equipment?

    (a) Vehicles and transportation equipment used in transportation
operations must be so designed and of such material and workmanship as
to be suitable and adequately cleanable for their intended use to
prevent the food they transport from becoming filthy, putrid,
decomposed or otherwise unfit for food, or being rendered injurious to
health from any source during transportation operations.

    (b) Vehicles and transportation equipment must be maintained in
such a sanitary condition as to prevent the food they transport from
becoming filthy, putrid, decomposed or otherwise unfit for food, or
being rendered injurious to health from any source during
transportation operations.
    (c) Vehicles and transportation equipment that are used in
transportation operations for food that can support the rapid growth of
undesirable microorganisms in the absence of temperature control during
transportation must be designed, maintained, and equipped, to maintain
the food under temperature conditions that will prevent the rapid
growth of undesirable microorganisms.
    (d) Each freezer and mechanically refrigerated cold storage
compartment in vehicles or transportation equipment used in
transportation operations for food that can support the rapid growth of
microorganisms in the absence of temperature control during
transportation, must be equipped with an indicating thermometer,
temperature-measuring device, or temperature-recording device installed
to show the temperature accurately within the compartment.
    (e) Vehicles and transportation equipment must be stored in a
manner as to prevent the vehicles or transportation equipment from
harboring pests or becoming contaminated in any other manner that could
result in food for which they will be used becoming filthy, putrid,
decomposed or otherwise unfit for food, or being rendered injurious to
health from any source during transportation operations.

Transportation Operations

Sec.  1.908  What requirements apply to transportation operations?

    (a) General requirements. (1) Unless stated otherwise in this
section, the requirements of this section apply to all shippers,
carriers, and receivers engaged in transportation operations.
    (2) Responsibility for ensuring that transportation operations are
carried out in compliance with all requirements in this subpart must be
assigned to competent supervisory personnel.
    (3) All transportation operations must be conducted under such
conditions and controls necessary to prevent the food from becoming
filthy, putrid, decomposed or otherwise unfit for food, or being
rendered injurious to health from any source during transportation
operations, including:
    (i) Taking effective measures such as segregation or isolation to
protect food from contamination by raw foods and non-food items in the
same load.
    (ii) Taking effective measures such as segregation, isolation, or
other protective measures such as hand washing, to protect food
transported in bulk vehicles or food not completely enclosed by a
container from contamination and cross-contact during transportation
operations.
    (iii) For food that can support the rapid growth of undesirable
microorganisms in the absence of temperature control during
transportation, ensuring that the food is transported in a manner,
including the temperature conditions, such that the transportation
operation meets the requirements of paragraph (a)(3) of this section.
    (b) Requirements applicable to shippers engaged in transportation
operations. (1) The shipper must specify to the carrier, in writing,
all necessary sanitary requirements for the carrier's vehicle and
transportation equipment, including any specific design requirements
and cleaning procedures to ensure that the vehicle is in appropriate
sanitary condition for the transportation of the food, e.g., that will
prevent the food from becoming filthy, putrid, decomposed or otherwise
unfit for food, or being rendered injurious to health from any source
during the transportation operation. The information submitted by the
shipper to the carrier is subject to the records requirements in Sec.
1.912(a).
    (2) Before loading food not completely enclosed by a container onto
a vehicle provided by a carrier or into transportation equipment
provided by a carrier, the shipper must visually inspect the vehicle or
the transportation equipment provided by the carrier for cleanliness.
The shipper must determine that the vehicle or transportation equipment
is in appropriate sanitary condition for the transport of the food,
e.g., it is free of visible evidence of pest infestation and of debris,
previous cargo, or dirt that could cause the food to become
adulterated.
    (3) A shipper of food that can support the rapid growth of
undesirable microorganisms in the absence of temperature control during
transportation, whether a TCS food or a non-TCS food, must specify in
writing to the carrier, except a carrier who transports the food in a
thermally insulated tank, the temperature conditions necessary during
the transportation operation, including the pre-cooling phase, to
ensure that the operation will maintain the temperature conditions and
meet the requirements of paragraph (a)(3) of this section. The
information submitted by the shipper to the carrier is subject to the
records requirements in Sec.  1.912(a).
    (4) Before loading food, a shipper of food that can support the
rapid growth of undesirable microorganisms in the absence of
temperature control during transportation, must verify that each
freezer and mechanically refrigerated cold storage compartment or
container has been pre-cooled in accordance with information submitted
by the shipper as required by paragraph (b)(3) of this section.
    (5) The shipper assumes the requirements applicable to the carrier
in Sec.  1.908(d)(2)(i) with respect to providing a demonstration to
the receiver if the shipper and carrier have agreed in writing under
Sec.  1.908(d)(2)(ii) that the shipper is responsible for ensuring that
the food was held under acceptable temperature conditions during
transportation operations. When the shipper and carrier have
established such an agreement, the shipper also assumes the
corresponding records requirements of Sec. Sec.  1.908(d)(6)(ii) and
1.912(b).
    (c) Requirements applicable to shippers and receivers engaged in
transportation operations. (1) Shippers and receivers must provide
vehicle operators who are expected to handle food not completely
enclosed by a container during loading and unloading operations with
access to a hand washing facility. The hand washing facility must be
convenient and provide running water to enable vehicle operators to
wash their hands and avoid contamination of food.
    (2) Shippers and receivers of food that can support the rapid
growth of undesirable microorganisms in the absence of temperature
control during transportation must carry out loading and unloading
operations under conditions that will prevent the food from supporting
such microbial growth.
    (d) Requirements applicable to carriers engaged in transportation
operations. (1) A carrier must supply a vehicle and transportation
equipment that meets any requirements specified by the shipper in
accordance with paragraph (b)(1) of this section and is otherwise
appropriate to prevent the food from becoming filthy, putrid,
decomposed or otherwise unfit for food, or being rendered injurious to
health from any source during the transportation operation.
    (2) A carrier:
    (i) Must, once the transportation operation is complete,
demonstrate to the shipper and if requested, to the receiver, that it
has maintained

temperature conditions during the transportation operation consistent
with those specified by the shipper in accordance with Sec.
1.908(b)(3). Such demonstration may be accomplished by any appropriate
means agreeable to the carrier and shipper such as the carrier
presenting printouts of a time/temperature recording device or a log of
temperature measurements taken at various times during the shipment.
    (ii) Is not subject to the requirement of paragraph (d)(2)(i) of
this section if the carrier and shipper agree in writing, before
transportation operations, that the shipper is responsible for
monitoring the temperature conditions during the transportation
operation or otherwise ensuring that the food was held under acceptable
temperature conditions during the transportation operation. The carrier
must provide the written agreement to the receiver, if requested. The
written agreement is subject to the records requirements of Sec.
1.912(b).
    (3) Before offering a vehicle or transportation equipment with an
auxiliary refrigeration unit for use for the transportation of food
that can support the rapid growth of undesirable microorganisms in the
absence of temperature control, a carrier must pre-cool each
mechanically refrigerated freezer and cold storage compartment as
specified by the shipper in accordance with paragraph (b)(3) of this
section.
    (4) A carrier that offers a bulk vehicle for food transportation
must provide information to the shipper that identifies the three
previous cargoes transported in the vehicle. The shipper and carrier
may agree in writing that the carrier will provide information that
identifies fewer than three previous cargoes or that the carrier need
not provide any such information if procedures have been established
that would ensure that the bulk vehicle offered will be adequate for
the intended transportation operation, e.g., if the carrier by
contract, will only offer vehicles dedicated to hauling a single type
of product. The written agreement is subject to the records
requirements of Sec.  1.912(b).
    (5) A carrier that offers a bulk vehicle for food transportation
must provide information to the shipper that describes the most recent
cleaning of the bulk vehicle, except that a shipper and carrier may
agree in writing that the carrier need not provide any such
information, if the carrier follows procedures that would ensure that
the bulk vehicle offered will be adequate for the intended
transportation operation, e.g., if the carrier has contractually agreed
to use a specified cleaning procedure at specified intervals or if the
shipper cleans the vehicle at his own facility. The written agreement
is subject to the records requirements of Sec.  1.912(b).
    (6) A carrier must develop and implement written procedures subject
to the records requirements of Sec.  1.912(b) that:
    (i) Specify practices for cleaning, sanitizing if necessary, and
inspecting vehicles and transportation equipment that the carrier
provides for use in the transportation of food to maintain the vehicles
and the transportation equipment in appropriate sanitary condition as
required by Sec.  1.906(b);
    (ii) Describe how it will comply with the provisions for
temperature control in paragraph (2) of this section, and;
    (iii) Describe how it will comply with the provisions for the use
of bulk vehicles in paragraphs (d)(4) and (d)(5) of this section.

Training

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

    (a) Carriers must provide training to personnel engaged in
transportation operations that provides an awareness of potential food
safety problems that may occur during food transportation, basic
sanitary transportation practices to address those potential problems
and the responsibilities of the carrier under this part. The training
must be provided upon hiring and as needed thereafter.
    (b) Carriers must establish and maintain records documenting the
training described in paragraph (a) of this section. Such records must
include the date of the training, the type of training, and the
person(s) trained. These records are subject to the records
requirements of Sec.  1.912(c).

Records

Sec.  1.912  What record retention and other records requirements apply
to shippers and carriers engaged in transportation operations?

    (a) Shippers must retain records that demonstrate that they provide
information to carriers as required by Sec.  1.908(b)(1) and (3) as a
regular part of their transportation operations for a period of 12
months beyond when the shipper is subject to any requirement to provide
such information.
    (b) Carriers must retain any written agreements required by Sec.
1.908(d)(2)(ii) of this subpart and records of the written procedures
required by Sec.  1.908(d)(6) for a period of 12 months beyond when the
agreements and procedures are in use in their transportation
operations.
    (c) Carriers must retain training records required by Sec.
1.910(b) for a period of 12 months beyond when the person identified in
any such records continues to perform the duties for which the training
was provided.
    (d) Shippers and carriers must make all records required by this
subpart available to a duly authorized individual promptly upon oral or
written request.
    (e) All records required by this subpart must be kept as original
records, true copies (such as photocopies, pictures, scanned copies,
microfilm, microfiche, or other accurate reproductions of the original
records), or electronic records, which must be kept in accordance with
part 11 of this chapter.
    (f) Except for the written procedures required by Sec.
1.908(d)(6), offsite storage of records is permitted after 6 months
following the date that the record was made if such records can be
retrieved and provided onsite within 24 hours of request for official
review. The written procedures required by Sec.  1.908(d)(6) must
remain onsite as long as the procedures are in use in transportation
operations. Electronic records are considered to be onsite if they are
accessible from an onsite location.
    (g) All records required by this subpart are subject to the
disclosure requirements under part 20 of this chapter.

Waivers

Sec.  1.914  Under what circumstances will FDA waive a requirement of
this subpart?

    FDA will waive any requirement of this subpart with respect to any
class of persons, vehicles, food, or nonfood products, when FDA
determines that:
    (a) The waiver will not result in the transportation of food under
conditions that would be unsafe for human or animal health; and
    (b) The waiver will not be contrary to the public interest.

Sec.  1.916  When will FDA consider whether to waive a requirement of
this subpart?

    FDA will consider whether to waive a requirement of this subpart on
FDA's own initiative or on the petition submitted under Sec.  10.30 of
this chapter by any person who is subject to the requirements of this
subpart with respect to any class of persons, vehicles, food, or
nonfood products.

Sec.  1.918  What must be included in the Statement of Grounds in a
petition requesting a waiver?

    In addition to the requirements set forth in Sec.  10.30 of this
chapter, the Statement of Grounds in a petition requesting a waiver
must:

    (a) Describe with particularity the waiver requested, including the
persons, vehicles, food, or nonfood product(s) to which the waiver
would apply and the requirement(s) of this subpart to which the waiver
would apply; and
    (b) Present information demonstrating that the waiver will not
result in the transportation of food under conditions that would be
unsafe for human or animal health and will not be contrary to the
public interest.

Sec.  1.920  What information submitted in a petition requesting a
waiver or submitted in comments on such a petition are publicly
available?

    We will presume that information submitted in a petition requesting
a waiver and comments submitted on such a petition does not contain
information exempt from public disclosure under part 20 of this chapter
and would be made public as part of the docket associated with this
request.

Sec.  1.922  Who will respond to a petition requesting a waiver?

    The Director or Deputy Directors of the Center for Food Safety and
Applied Nutrition (CFSAN) or the Center for Veterinary Medicine (CVM),
or the Director, Office of Compliance, CFSAN, or the Director, Office
of Surveillance and Compliance, CVM, will respond to a petition
requesting a waiver.

Sec.  1.924  What process applies to a petition requesting a waiver?

    (a) In general, the procedures set forth in Sec.  10.30 of this
chapter govern our response to a petition requesting a waiver.
    (b) Under Sec.  10.30(h)(3) of this chapter, we will publish a
notice in the Federal Register, requesting information and views on a
filed petition, including information and views from persons who could
be affected by the waiver if the petition were to be granted.
    (c) Under Sec.  10.30(e)(3) of this chapter, we will respond to the
petitioner in writing.
    (1) If we grant the petition, either in whole or in part, we will
publish a notice in the Federal Register setting forth any waiver and
the reasons for such waiver.
    (2) If we deny the petition (including partial denials), our
written response to the petitioner will explain the reason(s) for the
denial.
    (d) We will make readily accessible to the public, and periodically
update, a list of filed petitions requesting waivers, including the
status of each petition (for example, pending, granted, or denied).

Sec.  1.926  Under what circumstances may FDA deny a petition
requesting a waiver?

    We may deny a petition requesting a waiver if the petition does not
provide the information required under Sec.  1.918 (including the
requirements of Sec.  10.30 of this chapter), or if we determine that
the waiver could result in the transportation of food under conditions
that would be unsafe for human or animal health, or that the waiver
could be contrary to the public interest.

Sec.  1.928  What process will FDA follow when waiving a requirement of
this subpart on FDA's own initiative?

    If FDA, on its own initiative, determines that a waiver is
appropriate, FDA will publish a notice in the Federal Register setting
forth the waiver and the reasons for such waiver.

Sec.  1.930  When will a waiver granted by FDA become effective?

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

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

    FDA may modify or revoke a waiver if FDA determines that the waiver
could result in the transportation of food under conditions that would
be unsafe for human or animal health or that the waiver could be
contrary to the public interest.

Sec.  1.934  What procedures apply if FDA determines that a waiver
should be modified or revoked?

    (a) We will provide the following notifications:
    (1) We will notify the entity that initially requested the waiver,
in writing at the address identified in its petition, if we determine
that a waiver granted in response to its petition should be modified or
revoked.
    (2) We will publish a notice of our determination that a waiver
should be modified or revoked in the Federal Register. This notice will
establish a public docket so that interested parties may submit written
submissions on our determination.
    (b) We will consider timely written submissions submitted to the
public docket from interested parties.
    (c) We will publish a notice of our decision in the Federal
Register. The effective date of the decision will be the date of
publication of the notice.

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