maintain consistency with guidance we have issued, we have revised the
definition of ``transportation operations'' to state that molluscan
shellfish are not included in the provision that otherwise excludes the
transportation of live food animals from this definition.
    (Comment 79) Many comments support the exclusion of transportation
activities for RACs performed by farms and voice the view that the
exemption should be retained in our final rule. Several comments
advocate for limiting

the exclusion only to RACs that will undergo further processing and a
kill step before they are consumed. The comments argue that RACs
covered by the produce safety rule will not be processed further before
being consumed and therefore are particularly at-risk for becoming
contaminated during transportation. Some comments oppose this exclusion
provision. Some of these express the view that requirements for the
same activity should not differ based on who performs the activity and
argue that farm trucks transporting RACs should be covered under this
rule. Another comment asks us to include a separate section in this
rule that would apply to transportation activities for RACs performed
by farms, and states that RACs transported by farms at a minimum should
be subject to the rule's modification or revocation procedures
applicable to waivers. One comment asks us to engage with industry and
other key stakeholders, including trade associations, to establish a
maximum distance that a farm exempt from this rule should be able to
transport RACs.
    (Response 79) We are not aware of food safety concerns related to
the transportation of RACs by farms that could be addressed through the
sanitary transportation practices set forth in this rule, as we stated
in the proposed rule (79 FR 7006 at 7016). We also stated in the
proposed rule that we are not aware of instances in which insanitary
conditions or practices, for example, improper temperature control,
improper equipment construction, or inadequate equipment cleaning
involving the transportation of RACs by farms have contributed to
foodborne illnesses. We further stated that we recognize the diversity
of farms and their transportation operations, including the size of the
operation, the nature of the crop(s) being transported (e.g., large
trailer loads of dry grain or livestock, small loads of fresh produce
or shell eggs), the nature of existing transportation equipment (e.g.,
large tractor-trailers, small farm trucks and wagons), and the
destination of the shipment (e.g., a local cooling facility, farmers
market or restaurant, a more distant market), and the challenge that
this diversity presents in developing a set of mandatory requirements
that would be practical and broadly suitable for this sector.
Therefore, we tentatively concluded that the sanitary transportation
practices that would be required by this proposed rule are not
necessary to prevent RACs from becoming adulterated during
transportation by farms. We acknowledged that transportation from farm
to market is often performed by independent carriers as arranged by
shippers or receivers that are not farms. Similarly, farms may arrange
for transportation (i.e., serve as a shipper) by a common carrier.
Transportation by independent carriers, as compared to farms, is likely
to be over long distances and to involve the use of much larger
vehicles and transportation equipment that is generally more consistent
with equipment used outside the farm sector. Furthermore, long distance
transportation operations may involve several stops for dropping and
picking up additional loads. Communication and coordination between
carriers, shippers and receivers is a critical element in properly
carrying out such transport where different parties are handling
various transportation responsibilities, as opposed to transport
performed by a farm where the farm is responsible for all of the roles
covered by this rule except the receiver. To advance best practices for
the transport of produce, the industry has developed guidance that
addresses among other things, recommended practices for independent
carriers (Ref. 27). Building on industry experience we have concluded
that the requirements of this regulation should not apply to such
carriers with regard to the transportation of food by farms. We did not
receive any comments to the proposed rule that would cause us to alter
our determination to provide this exclusion or that convince us that
modifications or qualifying conditions should be added to the proposed
exclusion for transportation of food by farms.
    Upon further consideration, we have also concluded that the
exclusion from the transportation operations definition related to
transportation activities performed by farms should not be limited to
RACs. We are aware that farms ship and receive food items that are not
RACs (e.g., feed received to sustain their livestock, value added
packaged food, such as jams, honey, baked goods) and that these food
items are transported in the same manner as described earlier in this
document for RACs. We have concluded that the diverse handling of these
non-RAC food items by farms presents the same challenge for developing
a set of mandatory requirements that would be broadly suitable for this
sector, as described earlier in this document for RACs. For this
reason, we are removing the limiting clause ``for raw agricultural
commodities'' from the exclusion of transportation activities performed
by farms from the definition of transportation operations. Consistent
with the preamble to the proposed rule, the exclusion is intended to
apply to the activities of farms, regardless of whether the farm is
serving in the role of shipper, loader, carrier, or receiver.
    Section 416(d)(1)(A) and (B) of the FD&C Act provides us with the
authority to waive any requirement of this rule with respect to any
class of persons, vehicles, food, or nonfood products, if we determine
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. As we discussed in the proposed
rule with respect to the transportation of RACs (79 FR 7006 at 7016),
and are affirming herein, and as we discussed previously in this
response with respect to other types of food transported by farms, we
are not aware of food safety concerns related to transportation
activities performed by farms that could be addressed through the
sanitary transportation practices set forth in this rule. Accordingly,
the prerequisite condition for considering whether we should waive the
requirements of this rule for transportation activities performed by
farms does not exist, i.e., we are not aware of any concerns that would
necessitate establishing sanitary transportation requirements
applicable to such transportation operations, and therefore there are
no requirements for us to consider waiving.
    (Comment 80) One comment asserts that if transportation activities
for RACs performed by a farm are excluded from this rule, we should
clarify that a carrier would not be held responsible for any
contamination that may have occurred before the RACs were loaded into
the carrier's vehicle.
    (Response 80) Under this final rule, as revised, transportation
activities for any food, including RACs, performed by farms, while not
subject to the requirements of the rule, are still subject to the
adulteration and other applicable provisions of the FD&C Act and our
applicable implementing regulations. A farm that acts as a carrier, for
example, that transports RACs and that is excluded from this rule, is
still subject to section 402(a)(4) of the FD&C Act, which prohibits the
holding of food under insanitary conditions whereby it may be rendered
injurious to health or may become contaminated with filth.
    (Comment 81) One comment asks us to clarify whether fruit
transported to a processing facility falls under the proposed exclusion
for the transportation of RACs performed by a farm.

    (Response 81) Transportation activities for RACs, including fruit,
to processing facilities are excluded from coverage under this rule,
only if the activity is performed by a farm as defined in this rule.
However, farms subject to the produce safety rule will be required to
take steps to address the transportation of covered produce under that
rule. Section 112.125 of the produce safety rule requires that
equipment subject to that rule that is used to transport covered
produce must be adequately clean before use in transporting covered
produce and adequate for use in transporting covered produce.
    (Comment 82) One comment asks us to clarify whether this rule
applies to dairy farmers who transport bulk animal feed in their own
vehicles from a facility to their own farm. A second comment asks us to
clarify whether almond hulls and shells are eligible for the rule's
RACs transported by farms exemption.
    (Response 82) As we discuss in Comment 79, we have revised this
final rule to provide that all transportation activities performed by a
farm, and not solely those activities involving the transportation of
RACs, are not subject to this rule.
    (Comment 83) Some comments ask us to clarify whether this rule
applies to non-farm carriers who transport RACs on farms or from farms
to processing facilities where additional sanitation procedures or
microbial kill steps occur, for example, when fruit RACs are processed
at the receiving facility into canned fruit. Some comments argue that
RACs that are moved on a farm or from a farm to a processing facility
should not be subject to the requirements of this rule, regardless of
who owns and operates the vehicles and transportation equipment.
    (Response 83) Non-farm carriers, unless they are non-covered
businesses, engaged in transportation operations, as defined by this
rule for RACs, are subject to this rule regardless of whether the RACs
are intended to be further processed. While the RACs in question may be
further processed, there may be circumstances in which controls, for
example, a specific vehicle cleaning procedure, are necessary to ensure
that sanitary transportation practices are followed. We have added
provisions to Sec.  1.908(a)(3) of this rule to provide sufficient
flexibility to allow persons engaged in the transport of food intended
for further processing to use sanitary transportation practices that
are appropriate for their circumstances. The movement of RACs on a farm
that have not entered commerce is not subject to this rule because such
on-farm movement is not considered to be transportation, as defined in
this rule.
    (Comment 84) One comment agrees that transportation of a shelf
stable food that is completely enclosed by a container should be
excluded from coverage under this rule, as we proposed. It states that,
in addition, the exclusion should be extended to those same materials
shipped in dedicated bulk containers, so long as the containers meet
the criteria for sanitary food transportation.
    (Response 84) We wish to make it clear that this comment addresses
transportation equipment and not vehicles. We agree with this comment
provided that the shelf stable food as packaged within the equipment,
i.e., the reusable dedicated bulk container, is completely enclosed by
the container. As provided under the revised definition of
``transportation operations,'' the described container, when used to
transport any food that does not require temperature control for
safety, meets the criteria for exclusion from the definition of
``transportation operations.''
    (Comment 85) Several comments ask us to delete the word ``solely''
from the language in the definition of transportation operations
excluding activities associated with the transportation of shelf stable
foods from this definition. One comment states that the term ``solely''
is confusing and appears to suggest that shelf stable food should be
shipped in separate loads apart from non[hyphen]food items and other
covered food items.
    (Response 85) We agree that the word ``solely,'' as used in the
proposed definition of ``transportation operations,'' may be confusing
and we have concluded upon further consideration that it is not
necessary. We, therefore, have removed the term ``solely'' from the
definition of transportation operations.
23. Vehicle
    We proposed to define the term ``vehicle'' to mean a land
conveyance that is motorized, i.e., a motor vehicle, or that moves on
rails, i.e., a railcar, which is used in transportation operations. We
are finalizing this definition as proposed.
    (Comment 86) One comment asserts that the definition of ``vehicle''
as any ``land conveyance that is motorized'' and the use of the term
``motor vehicle'' are excessively broad and could be misinterpreted to
include a wide range of motorized vehicles, including automobiles. The
comment also notes that there are instances in which railcars, trucks,
and trailers can be used to store food products. This comment asks us
to narrow this definition to read: ``Vehicle means a truck or railcar,
which is used in transportation operations and not to hold food.''
    (Response 86) We decline to make the suggested change. The
definition of vehicle is intentionally broad and could include
automobiles. We do agree that sometimes railcars, trucks, and trailers
can be used to store food products, and we will incorporate that
possibility into our implementation of this rule. A truck or trailer
used for the permanent or semi-permanent storage of ingredients or
finished food products is not within the scope of this rule and could
be considered as part of a facility and regulated under another of our
applicable regulations, e.g., the FSMA human or animal preventive
controls rules that apply to the facility. A truck, trailer, or railcar
being used, or being prepared for use, to transport human or animal
food or food ingredients, would be subject to this rule. In either
case, the equipment would need to be used in a manner consistent with
the appropriate set of regulations, and in such a way that the food is
not rendered unsafe.

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

    In table 7 we outline the revisions we have made to Sec.  1.906 in
finalizing this rulemaking. Following the table we respond to comments
about these provisions and describe the changes we have made to the
provisions in finalizing the rule.

             Table 7--Sec.   1.906 What Requirements Apply to Vehicles and Transportation Equipment?
----------------------------------------------------------------------------------------------------------------
         Proposed section (Sec.   )                      Description                        Revision
----------------------------------------------------------------------------------------------------------------
1.906(a)....................................  Specifies that vehicles and       Removed the text that described
                                               transportation equipment must     the goal of the provision to be
                                               be designed and of such           prevention of food from
                                               material and workmanship to be    becoming ``filthy, putrid,
                                               suitable and adequately           decomposed or otherwise unfit
                                               cleanable for their intended      for food, or being rendered
                                               use to prevent food from          injurious to health from any
                                               becoming adulterated.             source'' from the regulatory
                                                                                text because we have narrowed
                                                                                the focus of this rule to
                                                                                adulteration linked to food
                                                                                safety. In the final rule, we
                                                                                have replaced this text with
                                                                                ``to prevent the food . . .
                                                                                from becoming unsafe, i.e.,
                                                                                adulterated within the meaning
                                                                                of section 402(a)(1), (2), and
                                                                                (4) of the FD&C Act.''
1.906(b)....................................  Specifies that vehicles and       Added ``for their intended use''
                                               transportation equipment must     to the regulatory text for
                                               be maintained in such sanitary    clarity.
                                               condition for their intended     Removed the text that described
                                               use to prevent food from          the goal of the provision to be
                                               becoming adulterated.             prevention of food from
                                                                                becoming ``filthy, putrid,
                                                                                decomposed or otherwise unfit
                                                                                for food, or being rendered
                                                                                injurious to health from any
                                                                                source'' from the regulatory
                                                                                text because we have narrowed
                                                                                the focus of this rule to
                                                                                adulteration linked to food
                                                                                safety. In the final rule, we
                                                                                have replaced this text with
                                                                                ``to prevent the food . . .
                                                                                from becoming unsafe.''
1.906(c)....................................  Specifies that vehicles and       Removed the phrases ``that can
                                               transportation equipment used     support the rapid growth of
                                               for food requiring temperature    undesirable microorganisms in
                                               control for safety must be        the absence of temperature
                                               designed, maintained and          control'' and ``maintain the
                                               equipped, as necessary, to        food under temperature
                                               provide adequate temperature      conditions that will prevent
                                               control to prevent the food       the rapid growth of undesirable
                                               from becoming adulterated.        microorganisms'' from the
                                                                                regulatory text because our
                                                                                goal with this provision is
                                                                                prevention of adulteration
                                                                                linked to food safety.
                                                                                Revised regulatory text to
                                                                                specify that vehicles and
                                                                                transportation equipment used
                                                                                for food ``requiring
                                                                                temperature control for safety
                                                                                must be designed, maintained,
                                                                                and equipped as necessary to
                                                                                provide adequate temperature
                                                                                control to prevent the food
                                                                                from becoming unsafe.''
1.906(d)....................................  Specifies that freezers and       Removed this provision as
                                               mechanically refrigerated cold    unnecessarily prescriptive.
                                               storage compartments to be
                                               equipped with an indicating
                                               thermometer, temperature
                                               measuring device, or
                                               temperature recording device to
                                               show the temperature accurately
                                               with the compartment.
1.906(e)....................................  Specifies that vehicles and       As a consequence of eliminating
                                               transportation equipment must     former 1.906(d), this provision
                                               be stored in a manner that        is finalized as 1.906(d).
                                               prevents harborage of pests or   Removed the text that described
                                               becoming contaminated in any      the goal of the provision to be
                                               other manner that could result    prevention of food from
                                               in food becoming adulterated.     becoming ``filthy, putrid,
                                                                                decomposed or otherwise unfit
                                                                                for food, or being rendered
                                                                                injurious to health from any
                                                                                source'' from the regulatory
                                                                                text because we have narrowed
                                                                                the focus of this rule to
                                                                                adulteration linked to food
                                                                                safety. In the final rule, we
                                                                                have replaced this text with
                                                                                ``to prevent the food . . .
                                                                                from becoming unsafe.''
----------------------------------------------------------------------------------------------------------------

1. Proposed Sec.  1.906(a)
    We proposed to require that vehicles and 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.
Consistent with a decision to more narrowly focus this rule on
adulteration linked to food safety as explained in responses to
comments below, we have finalized this provision to require that
vehicles and 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 unsafe, i.e., adulterated within the meaning of
section 402(a)(1), (2), and (4) of the FD&C Act during transportation
operations.
    (Comment 87) A comment from a non-profit organization that develops
and updates equipment standards and processing practices asks us to
include a provision in the final rule stating that vehicles and
transportation equipment that have been fabricated in conformance with
its standards and/or operated in accordance with its practices, and
have been maintained in a sanitary manner, will be deemed to have met
the minimum requirements of this rule.
    (Response 87) We are not making this suggested revision. It is the
responsibility of the persons subject to this rule to determine whether
the vehicles and transportation equipment that they use or offer for
use in food transportation operations meet the requirements of this
rule.
    (Comment 88) A few comments state that this regulation should not
preclude

the use of food transportation vehicles and equipment constructed of
wood, and ask us to clarify under what conditions we would deem the use
of vehicles and equipment constructed of wood to be acceptable.
    (Response 88) Similar to statements we made in the produce safety
rule (80 FR 74353) and final human food preventive controls regulation
(80 FR 55908) about wooden bins, we are not precluding the use of
transportation vehicles and equipment constructed of wood under this
rule. However, where the intended use of the vehicle or equipment is
such that food would be in direct contact with the wooden surface of
transportation vehicles or equipment, we expect that such vehicles or
equipment would be used only to the extent they are cleanable and
unlikely to support conditions that may make the food unsafe (see
Comment 95).
    (Comment 89) Several comments address provisions of this rule for
transportation equipment used in operations involving food materials
destined for animal consumption. One comment asserts that the
provisions in proposed 1.906(a), (b), and (e), do not seem to consider
the transportation of materials that are already in a condition not
suitable for consumption without further processing, such as viscera,
offal, and other byproducts from the chicken slaughtering process. The
comment notes that firms transport these materials to facilities where
they will be further processed and treated to recondition the materials
to make them suitable for animal consumption. Although the
transportation conveyances used to transport these materials to
processing facilities may, in fact, allow the growth of microorganisms
during transport, the subsequent treatment process accounts for this
and effectively renders the materials suitable for animal consumption.
A similar comment states requiring transportation conveyances for
animal food to be free of ``filthy, putrid, or decomposed substances''
should not apply to unprocessed raw materials destined for rendering.
These materials include offal and trimmings from animal slaughter, dead
animals, and spoiled or outdated meat from retail food establishments.
They are transported by renderers in specialized equipment to prevent
leakage and spills, but requirements related to refrigeration,
microbial contamination, decomposition, and adulteration during
transportation are not germane to these raw materials destined for
further processing and hazard control. Another comment asks us to
revise the rule to state explicitly that vehicles and transportation
equipment must be designed, maintained, and stored in appropriate
sanitary condition ``for their intended use.'' According to this
comment, doing so would clarify that different sanitary food
transportation requirements can be applied to vehicles and
transportation equipment, depending on the intended uses of the
vehicles and equipment, while still making it clear that appropriate
precautions must be followed in all circumstances. The commenter notes,
for example, that although byproduct materials do not need to be
transported under conditions that prevent them from becoming decomposed
because they already are in this condition at the start of
transportation, it would not be appropriate to transport these
materials in a container that previously held a chemical contaminant
that will not be eliminated through further processing if the container
was not adequately cleaned before use.
    (Response 89) We agree that in the proposed rule, we applied
language from section 402 of the FD&C Act identifying circumstances
under which food is adulterated in an overly broad manner so as to
suggest, unintentionally, that any food in transport that exhibits any
cited criteria of section 402 is adulterated, regardless of the nature
of the food or its intended use. We understand how a reader might
interpret proposed Sec. Sec.  1.906 and 1.908 to mean that vehicles
must be maintained and operated to always preclude food from becoming
filthy, putrid, decomposed or otherwise unfit for food during
transport, and that all food, including, for example, materials
destined for rendering, that become filthy, putrid, decomposed or
otherwise unfit for food as the result of transportation operations are
adulterated. We, therefore, have revised Sec.  1.906(a), (b), and (d),
and Sec.  1.908(a) to state that the relevant requirements for
transportation vehicles, equipment and operations take the intended use
of a vehicle or equipment into account and that the intent of these
requirements is to prevent food from becoming unsafe, i.e., adulterated
within the meaning of section 402(a)(1), (2), and (4) of the FD&C Act,
during transportation. Therefore, we would not regard a transportation
vehicle used to haul materials destined for rendering, e.g., viscera,
offal, trimmings from slaughter operations, to be operating under
insanitary conditions, given that the vehicle's intended use is to haul
materials that will undergo further processing to make them suitable
for animal consumption. We also would not regard rendering materials in
transport to be adulterated for the same reason. However, we note that
those engaged in transport of materials destined for rendering should
consider whether previous cargo that could cause the material to be
unsafe due to potential chemical contamination is a relevant
consideration.
    We also recognize that provisions in Sec. Sec.  1.906 and 1.908 of
the proposed rule that refer to the need, under certain circumstances,
for temperature control of food during transport to prevent the ``rapid
growth of undesirable microorganisms'' are used without appropriate
consideration of the intended use of the food, e.g., it is intended to
undergo further processing, and also suggest that any food in
transportation in which undesirable microorganisms are present is
adulterated. The proposed provisions further suggest that vehicles or
transportation equipment that allow these conditions to prevail are
insanitary for transportation purposes. We, therefore, have revised
Sec. Sec.  1.906(c) and 1.908(a)(3)(iii) in this final rule to state
that these requirements are applicable to food that requires
temperature control for safety during transportation. Unless otherwise
stated, we use the phrase ``food that requires temperature control for
safety'' in this rule to mean that such temperature control is needed
to prevent the food from becoming unsafe during transportation.
Therefore, we would not regard an unrefrigerated transportation vehicle
used to transport bulk materials destined for rendering to be in
violation of this rule because the vehicle's intended use is to
transport materials that do not require temperature control because
they will undergo a subsequent heat processing treatment to destroy
pathogens. We also would not regard rendering materials in transport,
e.g., viscera, offal, trimmings from slaughter operations, to be
adulterated for the same reason.
    As we discuss in our response to Comment 130, regarding revisions
we have made to proposed Sec.  1.908(a)(3), we are also clarifying
that, under this rule, the consideration of the type of food and its
stage in the relevant production cycle are relevant in determining the
necessary sanitary conditions and controls for any given transportation
operation.
    (Comment 90) One comment asks us to exempt equipment used for
transporting fruit and vegetable culls, for deposit into pastures as
food for grazing animals, from the bulk vehicle requirements of this
rule. It notes that Florida fresh citrus packinghouses often

load open-air dump trucks or dump trailers with culls for deposit onto
the ground of local pastures. The cattle eating the culls are grazing
animals and regularly feed from the ground. A similar comment asks us
to exempt transportation operations that use certain classes of
vehicles to transport raw and processed agricultural commodities, as
well as feed and feed ingredients, from this rule at the outset to
avoid a deluge of waiver petitions that this segment of the food
transportation industry would otherwise submit to us for our
consideration. This commenter singles out, for example, the use of
shuttle trains and privately owned railcars that are dedicated
exclusively to hauling grains and oilseeds as the types of
transportation operations that it believes should be exempt from the
rule. The comment also notes that animal feed and feed ingredient
manufacturers often use their own dedicated truck fleets to haul large
quantities of bulk and bagged products directly to farms and livestock
and poultry operations. The commenter believes that these types of bulk
vehicles and transportation equipment should be exempt from this rule
because they pose limited risks for cross-contamination because SOPs
for sequencing and cleaning-out these vehicles are already followed by
these firms in order to comply with FDA's existing regulations for
medicated animal feed.
    (Response 90) As we discuss in Comment 75, we have added a
provision to this final rule excluding human food byproducts
transported for use as animal food without further processing from
coverage by this rule. Therefore, transportation operations for fruit
and vegetable culls, for deposit into pastures as food for grazing
animals, are not subject to this rule.
    We do not agree that the other types of vehicles described in these
comments, or the transportation operations in which they are used,
should be exempt from this rule. The requirements we are establishing
for vehicles and transportation equipment, as we explained in our
response to the previous comment, require that vehicles and
transportation equipment be designed, maintained, and stored to prevent
food from becoming adulterated during transportation under the
vehicles' intended uses. These requirements are not burdensome and are
appropriate even for vehicles used in operations where the risk of food
adulteration is low.
    Finally, we note in response to the comment that bagged animal feed
and bagged animal feed ingredients are exempt from this rule. These
items fall outside of the scope of ``transportation operations'' (as
defined in Sec.  1.904) that are subject to the rule because they are
food completely enclosed by a container that does not require
temperature control for safety.
    (Comment 91) A few comments ask us to address the appropriate
sanitary conditions for the use of wood pallets. One comment observes
that wood is a porous material and therefore is vulnerable to water
absorption and potential contamination, but asserts that as long as the
food is in appropriate containers and does not come into direct contact
with wood pallet surfaces, the opportunity for contamination is slight.
Another comment asserts that the pallet conditions that we described as
being insanitary in the proposed rule are too restrictive for animal
feed transport and allow an FDA inspector too much subjectivity in
determining whether a pallet is fit for its intended use.
    (Response 91) Pallets need to be maintained so that they do not
pose a risk of contaminating food during transportation or of
compromising the integrity of the food containers that are supported by
the pallet. For example, where the intended use of the pallet is such
that food would be in direct contact with the wooden surface of the
pallet, we expect that pallets would be used only to the extent they
are cleanable and unlikely to support conditions that may make the food
unsafe. (See Comment 88). In addition, pallets should not have jagged
edges that protrude into the carrying surface in a way that could
damage the product being shipped, e.g., wood splinters that could
puncture food containers.
    (Comment 92) One comment asks us to amend the rule to allow
railcars currently in use to remain in use until they are retired from
service. The comment states that the absence of recent food safety
incidents involving the rail transportation of food demonstrates that
the design of railcars currently used in food transportation operations
is adequate.
    (Response 92) There are no provisions in this rule that would
require a railcar currently in use to be removed from service, as long
as its condition permits the safe transport of food in accordance with
established industry practices. If a railcar is in a condition not
suitable for such use, we would expect that the railcar provider would
take that car out of service for refurbishment or that the shipper
would refuse to use the car if it is offered for food transport.
    (Comment 93) A few comments state that the term ``adequately
cleanable'' used in proposed Sec.  1.906(a) is vague. One comment
asserts that it fails to provide any discernable benefit to food
transporters in preventing food contamination.
    (Response 93) As we state in our response to Comment 49, the term
``adequate'' is a long-standing term that we defined in its current
form when we first established cGMP requirements for the manufacturing,
packing, and holding of human food. We are using the terms ``adequate''
and ``adequately cleanable'' to provide flexibility for shippers,
loaders, carriers, and receivers to comply with the requirements of
this rule in a way that is both effective for purposes of preventing
the adulteration of food during transport and most suitable for their
particular operations.
    (Comment 94) One comment states that we should recognize that not
all transportation equipment needs to be cleaned before being used. The
comment observes that cleaning wooden pallets can do more harm than
good if proper precautions are not followed to prevent mold growth from
moisture. The commenter notes that while it may be appropriate to
expect water-based cleaning of certain types of transportation
equipment, like hoses, for example, between every use, these kinds of
cleaning practices should not be used for wooden pallets. The comment
states that a visual inspection of pallets for cleanliness and
suitability is sufficient to demonstrate that the pallets are
acceptable for use and that the ``adequately cleanable'' standard for
pallets should focus on the dry removal of debris like dust and dirt,
when necessary.
    (Response 94) We agree that there are circumstances under which
some transportation equipment would not need to be cleaned before each
use and that pallets that are adequately clean for their intended use
do not necessarily need to be cleaned after each use. However, when the
cleaning of vehicles and transportation equipment is necessary for a
transportation operation to meet the requirements of this rule, we
would expect that appropriate cleaning practices will be followed. We
address our principal concerns about the use of pallets in our response
to Comment 91.
2. Proposed Sec.  1.906(b)
    We proposed to require that vehicles and transportation equipment
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. Consistent with a decision to more narrowly
focus this rule on

adulteration linked to food safety as explained in responses to
comments below, we have finalized this provision to require that
vehicles and transportation equipment must be maintained in such a
sanitary condition for their intended use as to prevent the food they
transport from becoming unsafe during transportation operations.
    (Comment 95) One comment states that this rule should explicitly
distinguish between the terms ``sanitize'' and ``clean'' with respect
to the intended use of the food being transported. The comment states
that human food should be transported using equipment and vehicles that
have been ``sanitized'' to prevent illness while a ``clean'' vessel is
acceptable for the transport of animal feed.
    (Response 95) We did not define the terms ``sanitize'' or ``clean''
in the proposed rule and we decline the commenter's suggestion that we
do so in this final rule. Section 1.906(b) states that vehicles and
transportation equipment must be maintained in a ``sanitary
condition.'' We do not consider ``sanitary condition'' to be synonymous
with ``sanitize.'' We consider ``sanitary condition'' to be a state of
cleanliness. The term ``sanitize'' is associated with the reduction of
potentially harmful microorganisms. Section 1.906(b) further states
that the requisite sanitary conditions of vehicles and transportation
equipment are to be determined by the ``intended use'' of the vehicles
and equipment in order ``to prevent the food they transport from
becoming unsafe during transportation operations.'' Accordingly, as we
state in our response to Comment 2, we recognize that the applicable
sanitary transportation practices may vary depending on the types of
food that are being transported. More stringent practices, for example,
that might be necessary to ensure the sanitary transportation of one
type of food, e.g., human food or pet food, might not be necessary to
ensure the sanitary transportation of a different category of food,
e.g., animal feed. Our response to Comment 2 discusses revisions we
have made to Sec. Sec.  1.906 and 1.908 to clarify this point. However,
whether the transportation operation involves human food or animal
feed, the responsible persons under this rule must use all necessary
sanitary transportation practices, given their circumstances, to
prevent the food from becoming unsafe.
    (Comment 96) One comment states that proposed Sec.  1.906(b)'s
requirement that vehicles and transportation equipment, such as hoses
and pumps, be maintained in a ``sanitary'' condition is too ambiguous.
The comment asks what it means for vehicles and equipment to be clean
or sanitary, how we expect firms to meet this regulatory requirement,
and what other types of transportation equipment we anticipate will be
subject to this provision. The comment asserts that under certain
circumstances, animal feed for livestock can still be protected from
becoming unsafe even if the equipment used to transport it is not
sanitary, clean, or washed out prior to shipment. The comment states,
for example, that a firm can use dedicated equipment, product
sequencing, and equipment flushing with water or another appropriate
fluid followed by blowing the lines clear. Another comment states that
railway hopper cars and semi-trailers used for transporting feed
ingredients are not always dedicated to a single ingredient, but rather
frequently are also used to haul RACs. This comment notes that, as a
matter of current industry practice, cleaning between feed ingredient
and RAC loads is minimal because there is an assumption that minor co-
mingling of different plant materials does not result in adulteration
or otherwise present health hazards.
    (Response 96) We are requiring in Sec.  1.906(b) that vehicles and
transportation equipment must be maintained in such a sanitary
condition for their intended use as to prevent food from becoming
unsafe during transportation operations. We are not prescribing, in
this rule, methods (such as washouts) for the cleaning and maintenance
of vehicles and equipment, nor are we establishing required intervals
for cleaning operations. Firms may employ any cleaning procedures and
intervals that meet the requirements of this rule.
    (Comment 97) One comment states that the term ``sanitary'' as used
in proposed Sec.  1.906(b), and throughout the rule, is misleading
because its general meaning infers a standard that exceeds the common
understanding of the term ``clean.'' The comment states that
transportation equipment and containers for animal feed for livestock
do not need to be ``sanitary,'' but clean enough so as to prevent
adulteration of the feed. The comment suggests that we delete the word
``sanitary'' from the rule except when we refer to the transportation
requirements for human or pet food.
    (Response 97) We decline to remove, or otherwise limit the use of,
the word ``sanitary'' from this rule. We have not defined this term to
mean ``beyond clean'' and our use of this term in the rule is not
ambiguous. As we note in our response to Comment 95, we consider the
term ``sanitary'' to be a state of cleanliness and we do not consider
the term ``sanitary'' to mean that vehicles and transportation
equipment necessarily must be ``sanitized'' to ensure that food is not
rendered unsafe during transportation operations. We use the word
``sanitary'' in Sec. Sec.  1.906 and 1.908 as it would apply to the
conditions and controls employed for transportation operations,
vehicles, and equipment to ensure that food will not be rendered unsafe
during transportation. This is consistent with our responsibilities
under section 7202 of the 2005 SFTA, which states that we shall, by
regulation, require shippers, carriers by motor vehicle or rail
vehicle, receivers, and other persons engaged in the transportation of
food to use sanitary transportation practices prescribed by the
Secretary to ensure that food is not transported under conditions that
may render the food unsafe.
    Finally, as we also state in our response to Comment 2, we agree
that this rule should more clearly recognize that sanitary
transportation practices may differ depending on the types of food
being transported, for example, human food versus animal food. Our
response to that comment discusses revisions we have made to Sec. Sec.
1.906 and 1.908 to clarify this point.
    (Comment 98) One comment asks us to acknowledge that polymerized
oil residues that form on the interior steel surfaces of rail tanker
cars during the repeated hauling of edible oils for processing into
feed ingredients do not adulterate the oil. The comment notes that
these residues only present food quality concerns and are removed by
filtration and further processing.
    (Response 98) We agree. Residues that may form during edible oil
transportation operations as described in the comment, which we would
expect to be removed during further processing steps, are constituents
of the oil which are not toxic by nature and do not make the food
unsafe.
3. Proposed Sec.  1.906(c)
    We proposed to require that 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. Consistent
with a decision to more narrowly focus this rule on adulteration linked
to food safety and to add flexibility with regard to the approach to
monitoring

temperature control as explained in responses to comments below, in
this final rule we have revised proposed Sec.  1.906(c), with
consideration of the provisions of proposed Sec.  1.906(d), such that
final Sec.  1.906(c) requires that vehicles and transportation
equipment used in transportation operations for food requiring
temperature control for safety must be designed, maintained, and
equipped, as necessary, to provide adequate temperature control to
prevent the food from becoming unsafe during transportation operations.
    (Comment 99) Several comments ask that we acknowledge that means
other than refrigerated vehicles can be used to keep food adequately
cold during transport. These include the use of ice, dry ice, insulated
coolers, and cooler totes. Another comment asks us to clarify that
firms are not required to purchase cold foods from vendors with
refrigerated vehicles, that is, the comment seeks clarification that
firms can purchase cold foods from vendors who use means other than
refrigerated vehicles for purposes of maintaining necessary temperature
control of food products during transport.
    (Response 99) There is no requirement in this rule that foods
subject to temperature control requirements must be transported in
refrigerated vehicles or must be purchased from vendors with
refrigerated vehicles. The use of the alternative methods described in
this comment for keeping food cold during transport are acceptable
under this rule if the vehicles, for example, catering trucks and
commissary delivery vehicles, equipment, and transportation operations
comply with the requirements of Sec. Sec.  1.906 and 1.908.
4. Proposed Sec.  1.906(d)
    We proposed to require that each freezer and mechanically
refrigerated cold storage compartment in vehicles or 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 to show
the temperature accurately within the compartment. We have removed
Sec.  1.906(d) as proposed from the rule.
    (Comment 100) A few comments address this proposed requirement. A
participant at one of the public meetings we held on the proposed rule
stated that we should require a temperature recording device for all
transport vehicles that use refrigeration. One submitted comment states
that it should not apply to a carrier if the shipper has provided its
own device or relies on measures such as ice packs to maintain adequate
temperature control. Another comment asks us to explicitly permit the
use of hand-held temperature recording devices as an alternative to
devices installed in or on a cold storage cooler. A few comments assert
that low cost, time-temperature indicators are generally adequate for
temperature monitoring purposes and that we should not require the use
of expensive installed recording devices. A comment from the seafood
industry states that ensuring continuous temperature control during the
entire transit time requires the use of time-temperature recording
devices (or the effective use of ice or other cooling media) and that
indicating thermometers and temperature measuring devices are
inadequate because they do not provide continuous documentation of
temperature readings.
    (Response 100) We agree that there are a number of effective
methods for monitoring temperature control during food transportation,
some of which do not require the permanent installation of a device in
the compartment. We reconsidered this proposed provision and have
determined that persons subject to this rule should be able to use any
effective means to monitor temperature control, such as those suggested
by the comments, and that it is not necessary to retain this proposed
requirement. Therefore, we have removed this provision from this final
rule.
    (Comment 101) One comment also states that the proposed rule did
not discuss the need for temperature indicating devices to be checked
for accuracy and calibration.
    (Response 101) As we stated in our response to Comment 100, we have
removed the requirement that vehicles and transportation equipment be
equipped with a temperature indicating device from this final rule.
Therefore, there is no need to establish temperature measuring
equipment calibration requirements in this final rule.
5. Proposed Sec.  1.906(e)
    We proposed to require that 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. Consistent with a decision to more narrowly focus this rule
on adulteration linked to food safety as explained in responses to
comments that follow (particularly see Comment 89), in this final rule
we are requiring that vehicles and transportation equipment must be
stored in a manner that prevents it from harboring pests or becoming
contaminated in any other manner that could result in food for which it
will be used becoming unsafe during transportation operations. In the
final rule, this provision is redesignated Sec.  1.906(d) consistent
with the removal of proposed Sec.  1.906(d).
    (Comment 102) One comment notes that some end-users store pallets
used in transportation operations out-of-doors prior to use. The
comment argues that end-users' pallet storage practices are just as, if
not more, important for food safety than the programs and processes
followed by pallet manufacturers and that pallets must be stored in an
area with adequate light and airflow to prevent the formation of mold
on the pallets.
    (Response 102) We have established requirements for the storage of
transportation vehicles and equipment, including pallets, in Sec.
1.906(d). The outdoor storage of pallets is permissible if the pallets
meet the requirements of this section when they are used in
transportation operations, i.e., they must be in such a condition that
they will not cause the food that will be placed on them to become
unsafe. When pallets are used to hold fully packaged foods, no or
minimal cleaning may be necessary after outdoor storage. However, when
they are used in such a way that ready to eat food comes into contact
with the pallet, such as when they are used to hold some open mesh
crates of produce, cleaning may be necessary after outdoor storage,
especially if visible contaminants are present.
    (Comment 103) One comment states that railroad carriers shouldn't
be responsible for how a railcar is stored at a third-party facility
and asks us to clarify that the current industry practice of storing
railcars on spur tracks and in rail yards is acceptable.
    (Response 103) We agree that the storage of railcars on spur tracks
and in rail yards is acceptable if such storage meets the requirements
of this rule (e.g., it does not become infested with rodents in such a
way that subsequent cleaning will be ineffective). In most cases, empty
railcars will be cleaned by or for the shipper after such storage,
before use in holding food. However, if a railcar is stored in a manner
that can lead to food that is subsequently loaded onto it becoming
unsafe, that food may

be rendered adulterated. Determining who is responsible for such
adulteration would be performed on a case-by-case basis, according to
the specifics of the situation. As discussed in section IV.E.2., a
shipper must develop and implement written procedures adequate to
ensure that vehicles and equipment used in its transportation
operations are in appropriate sanitary condition for the transportation
of the food. These measures may be accomplished by the shipper or
undertaken by the carrier or a third party.

E. What requirements apply to transportation operations? (Sec.  1.908)

    In table 8, we describe revisions to proposed Sec.  1.908 and
following the table we respond to comments related to these provisions.

                   Table 8--Sec.   1.908 What Requirements Apply to Transportation Operations?
----------------------------------------------------------------------------------------------------------------
              Proposed section                           Description                        Revision
----------------------------------------------------------------------------------------------------------------
                  1.908(a)                    General Requirements
1.908(a)(1).................................  Requirements apply to all         Added ``loaders'' to the
                                               shippers, carriers, loaders,      provision and moved statement
                                               and receivers and a person may    out of individual definitions
                                               be subject to these               that a person could be, for
                                               requirements in multiple          example, both a shipper and a
                                               capacities.                       carrier.
1.908(a)(2).................................  Ensuring compliance with          No change.
                                               requirements must be assigned
                                               to competent supervisory
                                               personnel.
1.908(a)(3)(i)-(iii)........................  Transportation operations must    Replaced ``filthy, putrid,
                                               be conducted so as to prevent     decomposed or otherwise unfit
                                               food from becoming unsafe,        for food, or being rendered
                                               including taking measures such    injurious to health'' with
                                               as segregation, isolation, and    ``unsafe'' in 1.908(a)(3) and
                                               packaging to separate foods;      replaced description of ``food
                                               taking protective measures for    that can support the rapid
                                               food in bulk vehicles or not      growth of undesirable
                                               completely enclosed in a          microorganisms in the absence
                                               container from contamination      of temperature control'' with
                                               and cross contact; and ensuring   ``food that requires
                                               that food that requires           temperature control for
                                               temperature control for safety    safety'' in 1.908(a)(3)(iii).
                                               is transported under adequate
                                               temperature control.
1.908(a)(4).................................  Specify relevant factors (e.g.,   New provision.
                                               animal food vs. human food, raw
                                               material vs. finished food) in
                                               determining the necessary
                                               conditions and controls for the
                                               transportation operation.
1.908(a)(5).................................  Specify that shippers,            New provision.
                                               receivers, loaders and carriers
                                               which are under the ownership
                                               or operational control of a
                                               single legal entity, as an
                                               alternative to meeting the
                                               requirements of paragraphs (b),
                                               (d), and (e) of this section
                                               may conduct transportation
                                               operations in conformance with
                                               common, integrated, written
                                               procedures that ensure the
                                               sanitary transportation of food
                                               consistent with the
                                               requirements of this section.
1.908(a)(6).................................  If a covered entity becomes       New general requirement, which
                                               aware of an indication of a       was previously assigned to the
                                               possible material failure of      receiver in consultation with
                                               temperature control or other      the carrier and the shipper.
                                               conditions that may render the
                                               food unsafe the food shall not
                                               be sold or otherwise
                                               distributed until it is
                                               determined that the temperature
                                               deviation or other condition
                                               did not render the food unsafe.
                  1.908(b)                       Requirements applicable to
                                                           shippers
1.908(b)(1).................................  Requires that the shipper         Added ``loaders'' to the
                                               provide in writing to the         provision and the clause that a
                                               carrier and, when necessary,      shipper may take other measures
                                               the loader all necessary          in accordance with 1.908(b)(3).
                                               sanitary specifications for the   Added that a one-time
                                               carrier's vehicle and             notification of the sanitary
                                               transportation equipment to       specifications shall be
                                               prevent the food from becoming    sufficient unless the design
                                               unsafe. The shipper may take      requirements and cleaning
                                               other measures in accordance      procedures required for
                                               with 1.908(b)(3).                 sanitary transport change based
                                                                                upon the type of food being
                                                                                transported.
1.908(b)(2).................................  Shipper must specify in writing   Was proposed as 1.908(b)(3) and
                                               to the carrier, except a          required the shipper of a
                                               carrier who transports food in    ``Time/temperature control for
                                               a thermally insulated tank, and   safety'' (TCS) food to provide
                                               when necessary the loader an      information on the temperature
                                               operating temperature             conditions necessary for
                                               including, if necessary, the      transport in writing to the
                                               pre-cooling phase for a food      carrier to prevent the food
                                               requiring temperature control     from becoming filthy, putrid,
                                               for safety. Shipper may take      decomposed or otherwise unfit
                                               other measures in accordance      for food, or being injurious to
                                               with 1.908(b)(5) to ensure        health. The revised provision
                                               adequate temperature control.     focuses on the food safety
                                                                                concerns with temperature
                                                                                control.
1.908(b)(3).................................  Shipper must develop and          New provision.
                                               implement written procedures
                                               adequate to ensure that
                                               vehicles and equipment are in
                                               appropriate sanitary condition
                                               for the transport of food.
                                               Measures to implement the
                                               procedures may be done by the
                                               shipper or another party under
                                               the terms of a written
                                               agreement.
1.908(b)(4).................................  Shipper of food transported in    New provision.
                                               bulk must develop and implement
                                               written procedures adequate to
                                               ensure that a previous cargo
                                               does not make the food unsafe.
                                               Measures to implement the
                                               procedures may be done by the
                                               shipper or another party under
                                               the terms of a written
                                               agreement.

1.908(b)(5).................................  Shipper of food that requires     New provision.
                                               temperature control for safety
                                               must develop and implement
                                               written procedures to ensure
                                               the food is transported under
                                               adequate temperature control.
                                               Measures to implement the
                                               procedures may be done by the
                                               shipper or another party under
                                               the terms of a written
                                               agreement and must include
                                               measures equivalent to those
                                               specified for carriers under
                                               1.908(e)(1)-(3).
                  1.908(c)                       Requirements applicable to
                                                           loaders
1.908(c)(1).................................  Before loading food not           This new requirement for loaders
                                               completely enclosed by a          is similar to requirements that
                                               container, the loader must        were proposed for the shipper
                                               determine, based as appropriate   at proposed 1.908(b)(2), but
                                               on shipper specifications, that   the shipper may not be on site.
                                               the vehicle or transportation     Proposed 1.908(c)(1) was about
                                               equipment is in appropriate       access to handwashing
                                               sanitary condition (e.g.,         facilities and has been removed
                                               adequate physical condition,      from the rule.
                                               free of visible evidence of
                                               pest infestation, and previous
                                               cargo that could make the food
                                               unsafe).
1.908(c)(2).................................  Before loading food requiring     This new requirement for loaders
                                               temperature control for safety,   is similar to proposed
                                               the loader must verify,           1.908(c)(2), which required
                                               considering as appropriate the    shippers and receivers of food
                                               shipper specifications, that      that can support the rapid
                                               each mechanically refrigerated    growth of undesirable
                                               cold storage compartment or       microorganisms in the absence
                                               container is adequately           of temperature control to load
                                               prepared, including proper pre-   and unload under conditions
                                               cooling if necessary.             that would not support such
                                                                                growth. This new loader
                                                                                requirement is also similar to
                                                                                proposed 1.908(b)(4) which
                                                                                required shippers to verify
                                                                                that each mechanically
                                                                                refrigerated cold storage
                                                                                compartment or freezer has been
                                                                                properly pre-cooled.
1.908(d)....................................  Requirements applicable to        This provision specifically for
                                               receivers engaged in              receivers is new, resulting
                                               transportation operations.        from comments and our
                                              Upon receipt of a food requiring   understanding that receivers
                                               temperature control for safety,   would typically make a
                                               receivers must take steps to      determination that a shipment
                                               adequately assess that the food   may have been subject to
                                               was not subjected to              significant temperature abuse.
                                               significant temperature abuse,    Proposed 1.908(d) contained the
                                               such as determining the food's    provisions applicable to
                                               temperature, the ambient          carriers, which are finalized
                                               temperature of the vehicle, or    as 1.908(e) in this rule.
                                               smelling for off-odors.
                  1.908(e)                       Requirements applicable to
                                                           carriers
1.908(e)(1).................................  Per an agreement with the         Similar to proposed 1.908(d)(1)
                                               shipper that the carrier is       except ``filthy, putrid,
                                               responsible, the carrier must     decomposed or otherwise unfit
                                               ensure that vehicles and          for food, or being rendered
                                               equipment meet the shipper's      injurious to health'' has been
                                               specifications in accordance      replaced with ``unsafe'' per
                                               with 1.908(b)(1) is otherwise     our focus on adulteration
                                               appropriate to prevent the food   linked to food safety.
                                               from becoming unsafe.
1.908(e)(2).................................  Per an agreement with the         Similar to proposed 1.908(d)(2)
                                               shipper that the carrier is       which would have required the
                                               responsible, upon completion of   carrier to demonstrate to
                                               the transport and if requested    shippers and, if requested, to
                                               by the receiver, provide the      the receiver that temperature
                                               operating temperature specified   conditions were maintained
                                               by the shipper and, if            consistent with shipper
                                               requested by the shipper or       specifications. The revisions
                                               receiver, demonstrate that        in final 1.908(e)(2) are
                                               temperature conditions were       consistent with our new
                                               maintained during transport       provision in 1.908(d) that
                                               consistent with shipper           receivers take steps to
                                               specifications.                   adequately assess that the food
                                                                                was not subjected to
                                                                                significant temperature abuse.
1.908(e)(3).................................  Per an agreement with the         Similar to proposed 1.908(d)(3)
                                               shipper that the carrier is       except that the focus is on
                                               responsible, carriers must pre-   food requiring temperature
                                               cool each mechanically            control for safety rather than
                                               refrigerated cold storage         foods that support the rapid
                                               compartment as specified by the   growth of undesirable
                                               shipper before offering a         microorganisms, such as those
                                               vehicle for transport of food     that cause spoilage. The focus
                                               requiring temperature control     on food safety is also why the
                                               for safety.                       final provisions regarding pre-
                                                                                cooling have eliminated
                                                                                references to freezers, since
                                                                                it is likely that there would
                                                                                be significant quality defects
                                                                                with time/temperature abused
                                                                                frozen foods prior to the point
                                                                                at which they would become
                                                                                unsafe.
1.908(e)(4).................................  Per an agreement with the         Similar to proposed 1.908(d)(4),
                                               shipper that the carrier is       which would have required the
                                               responsible and if requested by   carrier to identify the three
                                               a shipper, a carrier that         previous cargoes. We realized
                                               offers a bulk vehicle must        that requiring provision of
                                               identify the previous cargo.      three previous cargoes was not
                                                                                necessary for food safety and
                                                                                we heard in comments that a
                                                                                carrier may not have any
                                                                                previous cargo information in
                                                                                the normal course of its
                                                                                business. Therefore, our final
                                                                                provision specifies that this
                                                                                information must be provided by
                                                                                the carrier if it agrees to
                                                                                provide the information.
                                                                                Otherwise, the shipper is
                                                                                responsible for considering the
                                                                                sanitary requirements necessary
                                                                                to prevent food from becoming
                                                                                unsafe during transport.

1.908(e)(5).................................  Per an agreement with the         Similar to proposed 1.908(d)(5),
                                               shipper that the carrier is       which would have required the
                                               responsible and if requested by   carrier to describe the most
                                               a shipper, a carrier that         recent cleaning of the bulk
                                               offers a bulk vehicle must        vehicle to the shipper. We
                                               provide information that          heard in comments that a
                                               describes the most recent         carrier may not have any
                                               cleaning of the vehicle.          previous cleaning information
                                                                                in the normal course of its
                                                                                business. Therefore, our final
                                                                                provision specifies that this
                                                                                information must be provided by
                                                                                the carrier if it agrees to
                                                                                provide the information.
                                                                                Otherwise, the shipper is
                                                                                responsible for considering the
                                                                                sanitary requirements necessary
                                                                                to prevent food from becoming
                                                                                unsafe during transport.
1.908(e)(6)(i)--(iii).......................  Carriers must develop and         No change from proposed
                                               implement written procedures      1.908(d)(6), except to change
                                               that (i) specify practices for    references to paragraph (d) to
                                               cleaning, sanitizing if           (e).
                                               necessary, and inspecting
                                               vehicles and transportation
                                               equipment to maintain them in
                                               appropriate sanitary condition,
                                               (ii) describe how it will
                                               comply with the temperature
                                               control requirements in
                                               1.908(e)(2), and (iii) describe
                                               how it will comply with the
                                               provisions for use of bulk
                                               vehicles in 1.908(d)(4) and
                                               (d)(5).
----------------------------------------------------------------------------------------------------------------

1. General Requirements (Proposed Sec.  1.908(a))
    We set forth in proposed Sec.  1.908(a) general provisions and
requirements applicable to transportation operations.
    (Comment 104) We received many comments expressing concern that the
proposed rule did not sufficiently recognize that practices for the
transportation of raw materials may differ from those for finished food
products, and that practices for the transportation of animal feed may
differ from those used to transport pet food and finished human food.
    (Response 104) We agree with the comments and have added new Sec.
1.908(a)(4) to make it clear that the type of food e.g., animal feed,
pet food, human food, and its' production stage e.g., raw material,
ingredient or finished food, are relevant to and must be considered in
determining the necessary conditions and controls for transportation
operations.
    (Comment 105) One comment expresses concern about the potential for
cross contamination during the transportation of RACs. The comment
states that the cross utilization of any equipment, including
transportation vehicles, should be conducted in a manner that does not
subject RACs to contamination and that equipment used to transport any
food products that are minimally processed and consumed raw should be
subject to sanitary requirements tailored to ensure the safety of the
products.
    (Response 105) We agree that cross utilization of vehicles and
equipment should not subject any food, including RACs, to cross
contamination during transport. The provisions of Sec.  1.906 require
the design, maintenance and storage of vehicles and transportation
equipment, to be such that they will not cause food to become unsafe
during transportation operations. In addition, Sec.  1.908(a)(3), which
in part addresses the proper use of vehicles and equipment in
transportation operations, requires that all transportation operations
must be conducted under such conditions and controls necessary to
prevent the food from becoming unsafe.
a. Proposed 1.908(a)(1)
    As previously discussed in the sections of this document related to
the definitions of carrier, shippers and receivers, we have removed
from these definitions the proposed sentence in each definition that
stated that a party may serve in more than one capacity under this
rule, e.g., a carrier may also be a receiver or a shipper, if the
person also performs the functions of those respective persons. While
we affirm that these statements are valid, we have consolidated them
into a new sentence at Sec.  1.908(a)(1), which states that a person
may be subject to these requirements in multiple capacities, e.g., the
shipper may also be the loader and the carrier, if the person also
performs the functions of those respective persons as defined in this
subpart.
b. Proposed 1.908(a)(3)
    (Comment 106) One comment asserts that the requirements of this
rule appear to duplicate warehousing and distribution requirements that
appear in the FSMA preventive controls for human food rule, which
require that food storage and transportation must be conducted under
conditions that will protect against cross-contact and biological,
chemical, physical, and radiological contamination of food, as well as
against deterioration of the food and its container.
    (Response 106) The preventive controls rule for human food
requirements in 21 CFR 117.93 provide broad good manufacturing practice
(GMP) standards for warehousing and transportation-related activities
that occur within the context of warehousing and distribution
operations of facilities engaged in the manufacturing, packing, and
holding of human food. This rule is intended to be complimentary to
those and other provisions of the Preventive Controls rules for human
and animal food and establishes more detailed requirements for
shippers, loaders, receivers, and carriers to use sanitary
transportation practices to ensure that food is transported under
conditions that will prevent it from becoming unsafe. This is FDA's
only rule that addresses the transportation of food in an integrated
manner from beginning to end by establishing the interactions that must
occur between shippers, loaders, carriers, and receivers to ensure that
sanitary food transportation practices are used by the food industry.
It is also the only rule to which carriers are directly subject.
Accordingly, this rule is not redundant, as asserted by this comment,
because it expands on the transportation-related requirements contained
in the GMPs.
    (Comment 107) A few comments question the appropriateness of using
the terms ``under such conditions and controls necessary to prevent the
food from becoming . . . decomposed or otherwise unfit for food'' to
describe requirements for transportation

operations. The comments state that fresh fruits and vegetables are
perishable food products and therefore by their very nature eventually
enter the senescence stage and begin to degrade (decompose) after they
are harvested. The comments further state that such foods can be in
this stage during transportation without yet becoming unfit for food.
These comments assert that we are confusing the concepts of food safety
and food quality by including these terms in this rule. The comments
state that the terms should be removed and that the final rule should
be strictly limited to ensuring the safe transportation of human and
animal food.
    (Response 107) We acknowledge in our response to Comment 89 that we
applied the language from section 402 of the FD&C Act in an overly
broad manner in the proposed rule, so as to suggest, unintentionally,
that any food in transport that is undergoing a natural process, i.e.,
senescense, is per se adulterated under this rule. As we also note in
our response to Comment 89, we have revised Sec.  1.908(a) in this
final rule to state that the intent of this provision is to prevent
food from becoming unsafe. We would not regard perishable fruits and
vegetables that are senescing during transport to be adulterated or
unsafe.
    (Comment 108) One comment encourages us to ensure that time/
temperature control provisions of this final rule will complement
related provisions contained in our seafood HACCP regulation.
    (Response 108) Our intent in drafting this final rule is to make it
compatible with the seafood HACCP rule, which does not include
requirements applicable to carriers. Under the seafood HACCP
regulation, receivers are required to ensure that transportation was
performed under appropriate temperature control, where such control is
necessary for the safety of the food. To accomplish this, receivers of
seafood often request temperature monitoring information from the
carrier upon receipt. As we discuss in our response to Comment 129,
this rule should assist receivers of seafood products by requiring
that, upon their request, carriers must provide the operating
temperature specified by the shipper and demonstrate that it has
maintained temperature conditions during the transportation operation
consistent with that operating temperature.
c. Proposed 1.908(a)(3)(i)
    We proposed to require that persons take effective measures, such
as segregation or isolation, to prevent raw foods and nonfood items
from contaminating other food products that might be shipped in the
same load during transportation operations.
    (Comment 109) One comment addressing proposed Sec.  1.908(a)(3)(i)
asserts that current industry practices ensure the adequate separation
of ready-to-eat food items from raw foods and nonfood items through the
use of packaging and impermeable barriers. The comment also states that
our Food Code (Ref. 28) also considers packaging to be an adequate
barrier for protecting food from contamination. Section 3-302.11 A. (4)
of the Food Code states that ``[f]ood shall be protected from cross-
contamination by storing the food in packages, covered containers, or
wrappings.'' The comment argues that because we acknowledged in the
proposed rule that industry has developed practices that ``ensure that
food is adequately protected from contamination by raw food items on
the same load,'' there is no need to include the ``segregation and
isolation'' language in this rule. The commenter further stated,
however, that if we retain this language in the final rule, we should
revise it to clarify that this provision should not be interpreted as
requiring the complete isolation of raw foods from ready-to-eat foods
during transportation.
    (Response 109) The 2005 SFTA mandates that we issue regulations to
require that shippers, carriers, receivers and other persons engaged in
the transportation of food use sanitary transportation practices to
ensure that food does not become adulterated during transportation. We
agree that both packaging, and segregation or isolation can be
effective means of protecting food from contamination by raw foods or
nonfood items in the same load. Therefore, we have revised proposed
Sec.  1.908(a)(3)(i) to include packaging as one of the examples of
such preventive measures during transportation operations.
d. Proposed 1.908(a)(3)(ii)
    We proposed to require that persons engaged in transportation
operations take effective measures such as segregation, isolation, or
other preventive 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.
    (Comment 110) One comment addressing proposed Sec.  1.908(a)(3)(ii)
asserts that persons who handle animal feed or raw feed ingredients
without using gloves or washing their hands are not going to
contaminate or adulterate food while engaged in loading, unloading, or
transportation activities. The comment, therefore, asks us to exempt
persons who handle animal feed from this provision.
    (Response 110) This provision does not require that persons who
handle animal feed or raw feed ingredients always wear gloves and/or
wash their hands. These measures are provided only as examples of steps
persons may take to meet the requirements of this rule. As proposed,
Sec.  1.908(a)(3)(ii) provides persons engaged in food transportation
the flexibility to determine for themselves which measures are
necessary to protect food transported in bulk vehicles or food not
completely enclosed by a container from contamination and cross-contact
during transportation operations. For this reason, we have not modified
this section.
e. Proposed 1.908(a)(3)(iii)
    We proposed to require persons engaged in the transportation of
food that can support the rapid growth of undesirable microorganisms in
the absence of temperature control during transportation to follow
transportation practices, including attention to temperature
conditions, to prevent the food from becoming filthy, putrid,
decomposed or otherwise unfit for food, or being rendered injurious to
health from any source.
    (Comment 111) Several comments ask us to reconsider including
temperature control requirements for non-TCS foods that require
temperature control only for purposes of preventing spoilage and not
for purposes of ensuring food safety.
    One comment states that because there are no potential safety
hazards associated with such non-TCS foods, strict transportation
temperature control requirements are not warranted. One comment
observes that we proposed to exempt facilities that hold completely
packaged refrigerated food from the requirements of the proposed FSMA
preventive controls rule for human food, with the exception of
facilities that hold TCS food. Under the preventive controls rule,
facilities that hold such TCS food are only subject to preventive
controls requirements to provide appropriate temperature control for
such food. The comment asserts that we should not impose more stringent
requirements on the transportation of food than we require for the
holding of food under the preventive controls rule. The comment asserts
that this rule, therefore, should not apply transportation requirements
for temperature control to non-TCS foods that require temperature
control

only for purposes of preventing spoilage.
    One comment acknowledges that the language of the 2005 SFTA is
somewhat different from the language FSMA in that it directs us to
issue regulations that are meant to ensure that food is not transported
under conditions that may render the food adulterated. The comment
further notes that adulteration is broadly defined by the FD&C Act and
can encompass issues such as food spoilage in addition to the narrower
issue of food safety. However, this comment states that such
considerations are already addressed by the FD&C Act's adulteration
provisions in section 402, and notes that FDA has the discretion to
implement the provisions of the 2005 SFTA in a manner consistent with a
risk-based framework focused more narrowly on food safety risks.
    Another comment states that while the temperature control
provisions of this rule should not address non-TCS foods, it does not
object to the inclusion of references in Sec.  1.906 to the prevention
of the rapid growth of undesirable microorganisms (which would include
microorganisms that cause spoilage) with respect to the design and
maintenance of vehicles and transportation equipment, and in Sec.
1.908 with respect to conditions for loading and unloading food,
because these provisions do not relate to the maintenance of
temperature control during transportation.
    (Response 111) We agree with the comments and explain in our
response to Comment 89 that we have revised this rule to require
temperature control only for foods that require temperature control for
safety. Conversely, the temperature control requirements do not apply
to food that is transported under temperature control for other
reasons, for example, for marketability purposes, or to prevent
spoilage of the food. In particular, we agree with the comment that
stated that nonsafety considerations are already adequately addressed
by the FD&C Act's adulteration provisions in section 402, and that we
have the discretion to implement the provisions of the 2005 SFTA in a
manner consistent with a risk-based framework focused more narrowly on
food safety hazards.
    We also have reconsidered whether to define a descriptive category
for the type of food (i.e., ``Time/Temperature Control for Safety (TCS)
Food'') that would be subject to the temperature control provisions of
this rule. We conclude that such a definition would serve no purpose
because the revision we discuss in the preceding paragraph adequately
designates the foods that would be subject to this rule's temperature
control requirements. Therefore, we have removed the term ``Time/
Temperature Control for Safety (TCS) Food'' in the definitions section
of this final rule in Sec.  1.904 and we have removed from this final
rule the descriptive categories, ``TCS and non-TCS,'' which appeared in
Sec.  1.908(b)(3) of the proposed rule.
    The temperature control requirements of this rule apply to any food
that requires temperature control for safety during transport, and
foods in the latter category, though not subject to the temperature
control requirements of this rule, are still subject to the
adulteration provisions and other applicable provisions of the FD&C Act
and applicable implementing regulations.
    (Comment 112) One comment asks us to rewrite the temperature
control provisions of this rule to clarify the requirements applicable
to TCS and non-TCS foods. Other comments recommend that we establish
temperatures for use by shippers in crafting instructions to be given
to carriers, to prevent discrepancies in temperature control
recommendations among shippers. Some comments also suggest that we
should provide guidance to the transportation industry for temperature
control that would include extensive lists of TCS and non-TCS foods.
One of these comments states that clarifying temperature controlled
food requirements and providing such guidance would have the added
benefit of assisting regulators tasked with the responsibility of
enforcing this rule. One comment asks us to establish a maximum
transportation temperature of 45 degrees Fahrenheit for TCS foods.
    (Response 112) We decline these requests. As we explain in our
response to the preceding comment, we have removed the term ``Time/
Temperature Control for Safety (TCS) Food'' from the definitions
section of this final rule in Sec.  1.904, and we have removed from
this final rule the descriptive categories ``TCS and non-TCS,'' which
appeared in Sec.  1.908(b)(3) of the proposed rule. We have replaced
the definition with the concept of ``foods that require refrigeration
for safety.''
    Because of the vast diversity of human and animal food types, FDA
does not have the resources to compile exhaustive lists of foods that
require or do not require temperature control for refrigeration nor a
list of the appropriate temperature controls for foods. Such a task is
made even more daunting because similar foods produced by different
manufacturers may have different temperature control requirements,
because of differences in formulation. We expect shippers of food to be
aware of whether the foods that they are shipping require refrigeration
for safety, either because they are the manufacturer of the food or are
otherwise knowledgeable about the food safety attributes of the food,
or because they have obtained such information from the manufacturer or
another knowledgeable person. The Preventive Controls rules for human
and animal food require the manufacturer of a food to consider the
transportation needs of foods that they manufacture when they develop
their food safety plans.
    Furthermore, as we explain in our response to Comment 129, we are
no longer requiring shippers to specify temperatures to carriers that
would be regarded as critical limits for food safety purposes. In many
circumstances, the shipper is required to specify an operating
temperature to the carrier, and the food is not necessarily unsafe or
otherwise adulterated if that temperature is exceeded during
transportation. Operating temperatures are generally set to allow for
refrigeration compartment temperature fluctuations due to normal
activities such as defrosting and opening and closing doors. They also
are often set to minimize product deterioration, which is usually a
more restrictive requirement than food safety. Regulatory limits for
operating temperatures would need to integrate all of these factors for
the diversity of foods and operations on the market. We will consider
establishing guidance in the future for operating temperatures for the
transportation of foods that require temperature control, should the
need arise.
    We disagree with the suggestion that we should establish a maximum
transportation temperature of 45 degrees Fahrenheit for TCS foods. As
we explain in our response to Comment 129, we have established
requirements, as revised in this final rule, that would preclude the
sale or distribution of any food that upon receipt presents an
indication of a possible temperature control material failure during
transport, unless it can be determined that the temperature deviation
has not rendered the food unsafe. We conclude that this is an
appropriate science-based approach to apply when assessing whether a
potentially significant temperature deviation has occurred during
transport because it provides for consideration of all significant
factors, e.g., the ability of the specific food to support pathogens
that are reasonably likely to be present in the food, and the duration
of the temperature deviation, rather than simply whether a

temperature limit was exceeded. Furthermore, allowing a TCS food to be
transported at temperatures up to 45 degrees Fahrenheit would not
provide appropriate temperature control for some TCS foods, which may
have to be transported at lower temperatures to ensure the safety of
the food, e.g., some vacuum packaged fish.
    (Comment 113) We requested comment in the proposed rule regarding
whether, unlike the proposed regulation, the final regulation should
apply to the transportation by farms of TCS RACs, which require time/
temperature control for food safety purposes, e.g., raw seed sprouts.
One comment offers the view that we should not include transportation
by farms of TCS RACs in this regulation and that the industry's current
best practices, which were not identified in the comment, sufficiently
protect TCS RACs from adulteration during transportation.
    (Response 113) As we discuss in our response to Comment 111, we
have removed the term ``Time/Temperature Control for Safety (TCS)
Food'' from the definitions section of this final rule in Sec.  1.904,
and we have removed from this final rule the descriptive categories
``TCS and non-TCS,'' which appeared in Sec.  1.908(b)(3) of the
proposed rule. Nonetheless, we received no comments that provided any
information that changed our tentative conclusion to exclude from
coverage TCS RACs when they are being transported by farms.
Consequently, we have made no change in that regard. However, when such
a RAC is being transported by a person other than a farm, it is subject
to the applicable provisions of Sec. Sec.  1.906 and 1.908 of this rule
that require transportation temperature control when it is necessary to
prevent the food from becoming unsafe.
    (Comment 114) One comment asks us to acknowledge that fresh whole
apples, pears, and cherries are transported under temperature control
exclusively for quality purposes. The comment also asks us to
acknowledge that we regard these fruits as being comparable to bananas,
which we stated in the proposed rule are not subject to proposed Sec.
1.908(a)(3)(iii) because there is no risk they will become adulterated
if they are transported under conditions that are not temperature
controlled. Another comment asks us to provide more examples of foods
that would not be subject to proposed Sec.  1.908(a)(3)(iii), and
suggests that these additional examples should include potatoes
intended for processing into potato chips and chocolate and dairy based
seasoning ingredients. The comment also asks us to train FDA inspectors
to understand the circumstances under which foods would or would not
require temperature control under this rule. Another comment asks us to
exclude nuts, which are sometimes refrigerated during transport for
quality purposes, from the scope of proposed Sec.  1.908(a)(3)(iii).
    (Response 114) This rule only requires temperature control during
transportation when it is necessary to prevent the food from becoming
unsafe. This rule does not establish requirements for the use of
temperature control during food transportation for any other purpose,
such as for marketability purposes, or to preclude the spoilage of food
subject to this rule. We will ensure that our inspectors understand
which factors generally distinguish foods that require temperature
control to prevent the food from becoming unsafe from other foods that
are transported under temperature control for quality purposes. As
discussed earlier in this document, shippers are responsible for
determining whether a food is subject to the temperature control
provisions of this rule, because they require temperature control for
safety. Whole, fresh apples, cherries, pears and potatoes are all
examples of foods that generally do not require temperature control for
safety. As we state in our response to Comment 112, we do not have the
resources to provide an exhaustive list of foods that are transported
under temperature control only for marketability purposes.
    (Comment 115) One comment asserts that the temperature control
provisions of this rule do not apply to the transportation of refined
fats and oils. The comment notes that the presence of temperature
specifications in transportation documents such as bills of lading is
related to quality and performance attributes of the refined fats or
oils, and therefore should not serve as a basis for extending this
rule's temperature control provisions to the transportation of refined
fats and oils. The comment also notes that refined fats and oils are
manufactured in closed systems and that the final product does not
support the growth of undesirable microorganisms.
    (Response 115) We recognize that there may be occasions where
temperature control is necessary for maintaining certain product
attributes such as product quality, but not to prevent the food from
becoming unsafe, as is the case, generally, for refined fats and oils.
If temperature control is not required to prevent the food from
becoming unsafe during transportation, the temperature control
provisions of this rule do not apply to those transportation
operations.
2. Requirements Applicable to Shippers Engaged in Transportation
Operations (Proposed Sec.  1.908(b))
a. Proposed Sec.  1.908(b)(1)
    We proposed to require that 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) of this rule.
    (Comment 116) One comment states that proposed Sec.  1.908(b)(1)
should be revised so that it would apply only to requirements for the
carrier's vehicle and transportation equipment that exceed the
carrier's basic obligation to provide vehicles and transportation
equipment that are clean, appropriate, and in safe condition for
transportation of the food intended to be shipped.
    (Response 116) As we state in our response to Comment 119, we are
aware that written information sharing between shippers and carriers
currently is a routine part of the working relationship between these
entities. We are retaining Sec.  1.908(b)(1) to ensure that all
necessary requirements for the preparation of a vehicle or
transportation equipment are communicated to carriers. However, this
provision allows the shipper to use reasonable judgment in deciding
what information must be communicated to a carrier to meet the
requirements of this rule. We understand that a shipper could
reasonably determine that it is not necessary to specify any procedures
that are commonly understood by carriers such as those described by the
comment.
    We have, however, modified this provision in several ways. First,
because we have added a definition of loader, in response to comments
that urged that we account for activities performed by the person
loading a vehicle when that person is not also the shipper, receiver or
carrier (see Comment 70). We recognize that there will be times when
the shipper must provide instructions to the loader in addition to the
carrier, e.g., instructions about any special sanitary

conditions to look for during the a preloading inspection. For this
reason, we have included the loader as a person to whom the shipper
must provide instructions about the sanitary specifications for the
carrier's vehicle, when necessary. Second, we have changed the word
``requirements'' to ``specifications'' in two places in this provision.
We believe that this word better conveys the idea of conditions set out
by the shipper to the carrier and loader, and is less likely to be
confused with regulatory requirements of the rule. Third, we have
changed the proposed phrase ``prevent the food from becoming filthy,
putrid, decomposed or otherwise unfit for food, or being rendered
injurious to health'' to ``prevent the food from becoming unsafe'' for
consistency with our previously stated objective of focusing this final
rule on food safety only. Finally, we have prefaced the requirement
with the phrase, ``unless the shipper takes other measures in
accordance with paragraph (b)(3) of this section, to ensure that
vehicles and equipment used in its transportation operations are in
appropriate sanitary condition for the transportation of the food.'' We
have added this language in response to comments from the railroad
industry (see Comment 53) that stated that they generally do not have a
relationship with shippers whereby the shipper provides them with
instructions relative to the sanitary condition of the railcar that
they are to deliver. Our intent is that the language will establish the
requirements of Sec.  1.908(b)(1) as the default arrangement whereby
the shipper ensures that the vehicle and equipment meet appropriate
sanitary conditions by providing instructions to the carrier and, when
necessary, the loader, while also allowing for alternative arrangements
(e.g., whereby the shipper personally ensures that the specifications
are met), when that is consistent with the shipper's written SOPs, as
provided for in Sec.  1.908(b)(3). We expect that many shippers that
work with rail carriers will elect this latter approach, relieving them
of the necessity to instruct the carrier about the necessary sanitary
conditions for the railcar.
    (Comment 117) One comment states that while obtaining written
specifications from a shipper about vehicle and equipment sanitation,
cleanliness procedures, and temperature requirements is an industry
best practice, it is not always feasible or practical. The comment
asserts that there is no evidence to suggest that shipper
specifications communicated verbally to the carrier instead of in
writing create a higher food safety risk.
    (Response 117) We continue to assert that written specifications
are consistent with industry best practice and are necessary to avoid
confusion about the responsibilities of the various parties engaged in
transportation operations. Such records are also valuable to assist FDA
and other regulatory agencies in their verification role.
    (Comment 118) One comment singles out proposed Sec.  1.908(b)(1) as
an example of a requirement for which we should afford firms
flexibility and latitude to vary the content and level of detail
contained in written specifications. The comment states that
flexibility is needed, for example, to account for variations in the
type of food type being transported, packaging, equipment, the
transportation environment, and the shipper's experience with the
carrier.
    (Response 118) We acknowledge that numerous, variable factors can
affect the types of procedures that are required to prepare a vehicle
or equipment to be offered to a shipper. For example, the nature of the
previous cargo transported in a tanker truck might affect the type of
cleaning procedure that would need to be followed to prepare the tanker
truck for its next cargo. We would expect that these types of factors
will affect the content and degree of detail contained in written
specifications that shippers would provide to carriers and loaders
under Sec.  1.908(b)(1). Nevertheless, the shipper must provide
specifications to the carrier, and loader as necessary, that are
adequate to enable them to ensure that the vehicle or transportation
equipment is in appropriate sanitary condition for the transportation
of the food, e.g., that will prevent the food from becoming unsafe
during the transportation operation.
    (Comment 119) One comment asserts that the food transportation
industry already has proven its ability to manage successfully
information sharing between shippers and carriers through, for example,
contractual agreements. The comment also asserts that proposed Sec.
1.908(b)(1) will only add an additional, unnecessary layer of
recordkeeping that will not add to the goal of feed safety, and that
Sec.  1.908(b)(1) seems unnecessary, given that we require carriers to
inspect transportation vehicles prior to loading. Finally, the comment
states that we should provide clarification regarding how frequently
information must be shared between shippers and carriers if we decide
to retain this provision.
    (Response 119) As this comment observes, written information
sharing between shippers and carriers engaged in food transportation
already is a part of the routine working relationship between these
entities. We do not envision that Sec.  1.908(b)(1) would require
additional information sharing above and beyond that which routinely
occurs and is necessary for purposes of enabling a carrier to offer a
vehicle or transportation equipment in appropriate sanitary condition
for the transportation of the food. Furthermore, the requirement in
proposed Sec.  1.908(b)(2), that a vehicle or transportation equipment
be inspected prior to loading prescribed cargoes, is a verification
step that also reflects existing best practice and does not obviate the
need for shippers to provide specifications to carriers that are
adequate to enable a carrier to offer a vehicle or transportation
equipment in appropriate sanitary condition for the transportation of
the food. Therefore, we are retaining this requirement.
    However, as we note in our response to Comment 124, we have added
language to Sec.  1.908(b)(1) stating that a one-time notification by a
shipper to a carrier, and, when necessary, to a loader, shall be
sufficient, unless there is a factor, e.g., the food or the conditions
of shipment change, necessitating a change in the design requirements
or cleaning procedures, in which case the shipper shall so notify the
carrier and, as necessary, the loader in writing before the shipment.
    (Comment 120) A comment observes that a shipment may change hands
many times during transit as it is transferred between carriers. The
comment notes that in these instances, the shipper is not in contact
with all of the subsequent carriers that may be involved and,
therefore, would not be in a position to ensure its original
requirements are met from start to finish. Therefore, the commenter
argues that the original carrier, which has initial responsibility for
ensuring that the food is handled in accordance with the shipper's
requirements, should be responsible for transferring that
responsibility to the next carrier down the line. The comment also
states that, although an overseas shipper is in the best position to
know the transportation conditions appropriate for a given food
shipment when it is initiated, the shipment could change hands after it
arrives in the United States and the sequential carriers, therefore,
should bear responsibility for ensuring that the food is handled in
accordance with the shipper's requirements.
    (Response 120) This rule would require that the shipper meet the
requirements of Sec.  1.908(b)(1) for all

segments of a shipment's transit, no matter how many carriers might be
involved in the transportation process. As we discuss in our response
to Comment 70, those requirements have been established for the shipper
based upon our determination that the person who arranges for the
transportation of food by a carrier, i.e., the shipper, is best suited
to perform these functions.
    (Comment 121) A comment addressing vehicle cleaning procedures
states that with the exception of food-grade tanker trucks, there are
no industry standards or protocols for cleaning and sanitizing vehicles
that transport food. The comment opines that, other than general
statements regarding the need to supply vehicles and transportation
equipment that prevent food from becoming adulterated, the rule seems
to allow shippers and carriers to agree upon the required cleaning
practices. The comment also offers the view that the flexibility
provided for by the rule may not be adequate, given the lack of any
industry standards or vehicle and equipment cleaning best practices.
Finally, the comment notes that if we elect to impose vehicle and
equipment cleaning standards, we must recognize that there are a
limited number of vehicle washout facilities available to the
transportation industry, and that they vary in the type of services
they are capable of providing.
    (Response 121) The commenter is correct that this rule provides
flexibility to shippers and carriers to determine the appropriate
protocols for cleaning transportation vehicles and equipment to comply
with the requirements of this rule. In general, we do not expect that
the requirements of this rule will necessitate a change in the
procedures for vehicle and equipment cleaning. Nonetheless, Sec.
1.908(b)(1) will require that these procedures be communicated to the
carrier in writing. However, as we stated in response to Comment 116,
this provision allows the shipper to use reasonable judgment in
deciding what information must be communicated to a carrier to meet the
requirements of this rule. We understand that a shipper could
reasonably determine that it is not necessary to specify any procedures
that are commonly understood by carriers, e.g., removal of dunnage,
sweeping. To the extent that there is a need for guidance on cleaning
procedures that go beyond those that are commonly understood, but not
as extensive as those for bulk tankers (for which there is written
industry best practice, as noted by the comment) we will consider
issuing guidance or working with industry trade associations to develop
written industry best practice on this subject.
    We are not establishing vehicle cleaning standards in this
rulemaking. This rule provides flexibility to shippers and carriers to
determine the appropriate protocols for cleaning transportation
vehicles and equipment to comply with the requirements of this rule. We
will consider issuing guidance on this subject in the future should the
need arise.
    (Comment 122) One comment asserts that the proposed rule lacks
sufficient flexibility to ensure that it can be implemented effectively
by the food transportation industry. According to the comment, shippers
are not always sufficiently knowledgeable to be able to specify ``all
necessary sanitary requirements for the carrier's vehicle and
transportation equipment.'' The comment also observes that shippers,
carriers, and receivers typically work together to establish sanitary
requirements that are appropriate for each particular type of food
shipment.
    (Response 122) Persons responsible for complying with this rule may
work with any other persons covered by this rule or third-party
experts, for assistance in developing their specifications. For
example, a shipper that is not the manufacturer may consult with the
manufacturer or with a third-party expert.
    (Comment 123) One comment states that the design and construction
of tanker trucks varies across the transportation industry and that
variations can occur even within a given vehicle manufacturer's model
lines. According to this comment, a preparatory procedure that is
suitable and adequate for one tanker, therefore, may not necessarily be
suitable and adequate for a differently designed or constructed tanker,
and only an individual carrier has the best knowledge of the
characteristics of its particular tanker.
    (Response 123) In order to prescribe the appropriate sanitary
conditions for shipment of a bulk cargo, the shipper must have
knowledge of the safety requirements of the food, as well as the
construction of the vehicle and transportation equipment. We expect
that the shipper will either have that knowledge based on prior
training or experience, or will obtain information from someone with
the necessary expertise. In the case of knowledge about the
construction of tankers, it may well be that the shipper's best source
of information will be from the carrier. An exchange of information
between the carrier and the shipper, leading to a written specification
from the shipper to the carrier, is fully consistent with the intent
and language of Sec.  1.908(b)(1).
    (Comment 124) One comment asks us to confirm that a shipper's
written communication required by proposed Sec.  1.908(b)(1) can be
executed for a particular commodity for the duration of its agreement
with each carrier rather than just for each particular product load. A
second comment suggests that this requirement should specify that one-
time notifications will be sufficient unless the design requirements
and cleaning procedures required by the shipper change because of
changes in the types of food being transported, in which case the
shipper would be required to supply the carrier with a new written
notification.
    (Response 124) We agree with both commenters. Therefore we have
added the language to Sec.  1.908(b)(1) in this final rule that states
that one-time notification shall be sufficient unless a factor, e.g.,
the food or the conditions of shipment, changes, necessitating a change
in the design requirements or cleaning procedures, in which case the
shipper shall so notify the carrier, and, as necessary, the loader, in
writing before the shipment.
b. Proposed Sec.  1.908(b)(2)
    We proposed to require that a shipper must visually inspect the
vehicle or the transportation equipment provided by a carrier for
cleanliness before loading food that is not completely enclosed by a
container onto a vehicle or into transportation equipment provided by
the carrier. We proposed that the shipper would have to determine that
the vehicle or transportation equipment is in appropriate sanitary
condition for the transport of the food, for example, that it is free
of visible evidence of pest infestation and of debris, of previous
cargo, or of dirt that could cause the food to become adulterated
(revisions to the proposed provision are discussed in Comment 89). As
we previously discuss in several sections of this document,
responsibility for the pre-loading inspection no longer resides with
the shipper, as we had initially proposed. Rather, in this final rule,
the loader now bears this responsibility under Sec.  1.908(c)(1).
    (Comment 125) One comment states that proposed Sec.  1.908(b)(2) is
inapplicable to bulk liquid tanker shipments because personnel do not
enter the cavity of a tanker after it has been cleaned and made ready
for loading. The comment recommends that we modify this requirement to
make it goal-based by requiring the shipper to determine that the
vehicle or transportation equipment is in sanitary

condition for the transport of the food by any appropriate means. The
comment also asks us to provide examples of ways to accomplish this,
for example, through the use of visual inspection, documentation, or
cleaning.
    (Response 125) We agree that the pre-loading inspection requirement
in this final rule should specify the inspection's objective without