restricting it to a specific method, e.g., visual inspection. We have
decided that the objective of pre-loading inspections should be a
determination that the vehicle or equipment is in appropriate sanitary
condition for the transport of food. At times, e.g., transportation of
food that is not fully enclosed by a container, such an inspection
would generally involve a visual inspection to ensure that the walls,
floors, and ceiling of the vehicle are adequately clean, such that they
are not likely to cause the food to become unsafe during
transportation. However, at other times, e.g., bulk shipments in tanker
trailers, the tanker trailer may already be washed and sealed before it
arrives at the shipper's place of business, and the inspection may be
as simple as checking for a wash ticket. We therefore have revised this
provision in Sec.  1.908(c)(1) to state that the loader must determine
through the pre-loading inspection process that the vehicle or
transportation equipment is in appropriate sanitary condition for the
transport of the food, e.g., it is in adequate physical condition, and
free of visible evidence of pest infestation and previous cargo that
could cause the food to become unsafe during transportation. We have
also revised this provision to state that this inspection may be
accomplished by any appropriate means.
    (Comment 126) One comment states that checking for the physical
condition of a vehicle during the pre-load inspection, for example,
checking for holes in the floor, walls and ceiling and the presence of
off-odors and stains that might constitute residual evidence of a
chemical spill or pooled water, is not specifically included in
proposed Sec.  1.908(b)(2). The comment recommends that we expand the
scope of the pre-loading inspection to include these items.
    (Response 126) We agree that in certain circumstances, e.g.,
transportation of food that is not fully enclosed by a container, the
items discussed in the comment should be included in a pre-loading
inspection. However, we are not specifying pre-loading inspection
requirements in this rule because the nature of these inspections may
vary from one type of operation to another depending on what would be
necessary to determine that the vehicle or equipment is in acceptable
sanitary condition for its intended use for the transportation of food.
We have added the physical condition of the vehicle as an example of
what may be included in a pre-loading inspection in Sec.  1.908(c)(1)
of this final rule.
    (Comment 127) A comment states that, during the transport of animal
feed, the carrier's driver often performs loading functions without
having a shipper's employee present. The comment notes that this
practice is established through contract stipulations between the
shipper and carrier. The shipper may also choose to inspect the truck,
depending on the feed to be loaded and customer requirements. The
comment further states that, as a practical matter, a bulk trailer is
often inspected after delivering a load to ensure that all the feed was
delivered and that it is ready for loading the next load. The commenter
asserts that this practice and verification of the last load delivered,
in addition to contract requirements, sufficiently ensures the safety
of the feed.
    (Response 127) This comment describes a situation where the carrier
is also the loader. The practices described by the comment are
consistent with the provisions of the final rule. In Sec.  1.908(c),
this rule requires loaders, in this case also the carrier, to take
actions before loading food not completely enclosed by a container onto
a vehicle or into transportation equipment to determine that the
vehicle or transportation equipment is in appropriate sanitary
condition for the transport of the food. In this case, where a
dedicated bulk truck is repeatedly used for the same cargo that does
not require refrigeration for safety, e.g., animal feed, an inspection
of the inside of the bulk vehicle after delivery of a load may be
sufficient to ensure that it is in a suitable condition for loading the
next shipment.
    (Comment 128) A few comments address proposed Sec.  1.908(b)(2)
within the context of partial load shipments, which are also known as
less-than-truckload (LTL) shipments. LTL shipments are those in which
additional loads are subsequently added to a partially loaded truck.
These comments state that the shipper of a partial load will likely be
present only for the loading of its own shipment, but not for
subsequent loads, and therefore cannot ``visually inspect the vehicle .
. . for cleanliness'' or ensure ``that the vehicle . . . is in
appropriate sanitary condition'' for subsequent loads. One of these
comments states that the rule must also account for cross-docking
situations in which cargo is transferred from the original vehicle to
another vehicle or mode of transport. In cross-docking transfers,
employees of neither the shipper nor receiver will be present during
loading into the subsequent vehicle, and the subsequent vehicle may
even be from another carrier.
    (Response 128) Under this final rule, the loader, and not the
shipper or receiver, is responsible for performing the inspection upon
loading as required by Sec.  1.908(c)(1). This requirement would apply
to the loader for each sequential loading of a vehicle that makes
multiple stops to pick up partial loads. This also applies to the
loader for a trans-loading (cross docking) operation, as we discuss in
our response to Comment 38.
c. Proposed Sec.  1.908(b)(3)
    We proposed to require that a shipper of food that can support the
rapid growth of undesirable microorganisms in the absence of
temperature control, whether a TCS food or a non-TCS food, must specify
in writing to the carrier, except to a carrier who transports the food
in a thermally insulated tank, the temperature conditions needed during
the transportation operation, including the pre-cooling phase, to
ensure that the carrier will maintain the proper temperature and meet
the requirements of Sec.  1.908(a)(3). We also proposed to make this
information subject to the records requirements in Sec.  1.912(a) of
this rule.
    (Comment 129) A large number of comments oppose our proposed
provisions in Sec.  1.908(b) and (d) for shippers and carriers engaged
in the transportation of temperature controlled foods. These comments
urge us to incorporate provisions into this rule that would allow for
the continued use of existing food transportation industry best
practices that have proven to be effective. They argued that management
of temperature control for foods during transportation is a complex
issue because it involves interactions between shippers, carriers and
receivers who must address a variety of circumstances that may arise
during the transportation of the food. We will first summarize the
numerous comments we received on this matter.
     These comments universally oppose any requirement that
carriers routinely demonstrate for each delivered load that they have
met shipper temperature specifications. They state that confirming the
functionality and settings of the refrigerator unit, or the temperature
of the compartment upon loading and

upon receipt, and visually inspecting the food upon arrival for signs
of temperature abuse is sufficient. The comments note, for example,
that when a truck arrives at its destination, the receiver checks the
trailer temperature setting. The receiver often also conducts a visual
inspection to confirm that there are no visible signs of temperature
abuse, such as sweating, the presence of ice crystals, signs of
moisture, leaking products, moisture damage to packaging, or the loss
of the structural integrity of packaging. According to these comments,
checking the temperature of the food itself after transport has not
been found to be necessary for purposes of ensuring food safety. The
comments state that this is the case, in part, because if a
refrigeration unit is turned off during shipment long enough to affect
the temperature of the food product, a visual inspection of the food
would be sufficient for purposes of determining whether a material
temperature deviation that would have affected the safety of the load
had occurred. The comments, therefore, assert that the current standard
industry practice in most cases is to request temperature information
about the load from the carrier upon delivery if there is a suspected
food safety problem, for example, as indicated by a visual inspection.
     These comments also note that truck trailers often have
devices onboard that can continuously record the refrigeration unit
temperature that can be reviewed when necessary to investigate
potential temperature deviations during transport that could affect
food safety. These comments state, however, that this recorded
information can be difficult to download and takes considerable time
and expense to analyze because the process involves, among other
things, identifying the container unit in transit, removing it from
service, and delivering it to a facility capable of downloading the
data. The comments further state that the cost of just extracting the
data can be up to $200 per load and may require the services of a
third-party vendor and that additional expense is incurred in analyzing
the data. The comments therefore conclude that requiring the routine
review of recorded onboard refrigerator temperature data is neither
practical nor necessary.
     These comments also argue that the language of proposed
Sec.  1.908(d)(2)(i) could be interpreted to require continuous
temperature monitoring during food transport and suggest that we may be
under the misimpression that the use of continuous monitoring devices
is the norm in the refrigerated food transport industry. Some comments
state that current best industry practices in many cases can give
shippers confidence that appropriate temperatures are maintained during
transit, without the use of continuous monitoring devices. One comment
urges us to permit other forms of adequate temperature monitoring, such
as documented alarm systems or properly documented manual temperature
records. Many comments state that the rule should allow the carrier to
use any means agreeable to the shipper to demonstrate the carrier's
adherence to temperature specifications, such as recording trailer
temperature settings when the vehicle is loaded and unloaded or
periodic temperature checks during transit. Finally, some of the
comments note that with the limited exception of the transportation of
highly temperature-sensitive food products, such as vacuum packed
seafood, where the shipper or receiver voluntarily may determine that
the use of continuous monitoring devices is necessary to ensure product
safety, using continuous temperature monitoring and recording devices
is not necessary for purposes of ensuring the safety of the food during
transport.
     These comments also state that a deviation from the
shipper's temperature specifications does not necessarily cause the
food to be unsafe. According to the comments, the temperature included
in a shipment's bill of lading is the temperature at which the
trailer's refrigerator unit needs to be set, but is often lower than
the temperature needed to ensure the safety of the food shipment. A
food that requires time/temperature control to ensure its safety (TCS
food) and needs to be maintained at or below 40 degrees Fahrenheit, for
example, may be transported during the winter in cold regions of the
country at refrigerator settings very close to 40 degrees because this
is adequate to ensure the temperature required for safety is not
exceeded given the low outside air temperature. If, however, this food
is transported during the summer, the shipper may direct the carrier to
set the refrigerated trailer temperature much lower than 40 degrees
Fahrenheit (e.g., 33 degrees Fahrenheit) because the warmer outside air
temperature could cause the ambient temperature in the trailer to rise
during transit. In this scenario, according to these commenters, the
ambient temperature in the trailer upon arrival at the receiver's
facility may be 36 degrees Fahrenheit, but this does not mean that the
food is unsafe, even though the temperature is higher than what was
indicated in the shipment's bill of lading. These comments conclude
that for these reasons, this rule should clearly state that a deviation
from the shipper's temperature specifications does not necessarily
cause the food to be unsafe.
     Finally, these comments urge us to accord shippers the
flexibility to assess the conditions under which the food was
transported in determining whether temperature deviations cause the
food to be unsafe. The commenters assert that, in many cases, the food
may still be fit for its original intended use, notwithstanding any
temperature deviations that might have occurred during transit. The
comments also assert that in a case where a food may no longer be fit
for its original intended use because of temperature deviations, the
food may still be fit for an alternative use. A food product that may
no longer be fit for its intended use as food for humans because of
temperature deviations that might have occurred during transit, for
example, might still be safe and fit for use as animal food. The
comments argue that automatically deeming food adulterated because
there was a temperature deviation during transit, without allowing for
an evaluation of whether that deviation affected the safety of the
food, would result in significant amounts of food waste without
providing any corresponding food safety benefit.
    (Response 129) We agree that the provisions we proposed for persons
engaged in the transportation of foods that require temperature control
for safety should be revised to clearly focus their requirements on
functions that ensure that adequate temperature control is provided,
and to permit the continued use of established industry best practices
that provide for the safe transportation of these foods. In revising
these provisions, which are now designated as Sec.  1.908(b)(2) in this
final rule, we considered the steps that occur before, during, and
after the transportation of foods that require temperature control for
safety to ensure the transportation operation is in accord with
sanitary transportation practices. Our changes to this final rule
involve revisions that affect the responsibilities of shippers (Sec.
1.908(b)), loaders (Sec.  1.908(c)), receivers (Sec.  1.908(d)), and
carriers (Sec.  1.908(e)).
    In revising this rule's provisions for foods that require
temperature control for safety during transportation, we recognized the
fact, expressed in several comments, that the temperature control
measures we are establishing in this rule may not be necessary for some

transportation operations, e.g., those conducted during winter in cold
areas or for short distance transportation of food in appropriate
circumstances. As such, we are using in Sec.  1.908(b)(2), the phrase,
``food that requires temperature control for safety under the
conditions of shipment,'' to indicate that the requirements of this
provision do not apply in situations in which the shipper determines
that they are not necessary to ensure that the food does not become
unsafe during transportation. We would expect that a shipper would be
able to articulate the basis for any such determination if asked why
temperature control is not necessary under the conditions of shipment.
    Under conditions of shipment where it is necessary to provide
temperature control to ensure that food does not become unsafe during
transportation, the shipper must provide written instructions to the
carrier and, when necessary (e.g., if the shipper is not also the
loader), to the loader, specifying temperature conditions to be
maintained during transport.
    The comments we received clearly state that this provision, as
proposed, may be interpreted to mean that we are requiring the shipper
to specify a critical limit for the transport of the food, such that
food held in a vehicle that exceeds the specified temperature may be
unsafe and, therefore, adulterated. We recognize that under established
industry practices, the temperature specification provided to a carrier
is often lower than the temperature needed to ensure food safety and
that if the ambient temperature in a trailer were to exceed the
specified temperature, the food would not necessarily be unsafe. We
agree with the comments that ask us to clarify that a deviation from
the shipper's temperature specifications does not necessarily and
automatically cause the food to be unsafe, and, therefore, adulterated.
Therefore, we are revising this provision in Sec.  1.908(b)(2) to
require that the shipper specify to the carrier, and, when necessary,
to the loader, an operating temperature required for the given
transportation operation, including, if necessary, the pre-cooling
phase. We are adding a definition for the term ``operating
temperature'' in Sec.  1.904 to state that this term means a
temperature sufficient to ensure that under foreseeable circumstances
of temperature variation during transport, e.g., seasonal conditions,
refrigeration unit defrosting, multiple vehicle loading and unloading
stops, the operation will meet the requirements of Sec.  1.908(a)(3).
This revision clarifies that we do not intend for the temperature
specified by the shipper to the carrier to be used as a critical limit,
and that we understand that the specified temperature might be exceeded
because of foreseeable circumstances that occur during transport, and
that such deviations do not necessarily cause the food to become
unsafe, and, therefore, adulterated.
    We next considered how this rule should address temperature
monitoring during transportation and under what conditions data
acquired during temperature monitoring should be communicated by a
carrier to a receiver or shipper. The comments we received clearly
state that under established industry practices, parties involved in
food transportation use a wide variety of approaches for monitoring
temperature conditions. In some instances, for example, the
transportation of some vacuum packaged seafood products, the continuous
monitoring of temperature during transportation is necessary to ensure
that the food is maintained under safe conditions. In most other
instances, the transportation industry relies primarily on means, other
than reviewing temperature monitoring information acquired during
transit, to establish that adequate temperature control was provided
during transportation, e.g., vehicle temperature checks at loading and
unloading, product temperature checks at receiving. In some instances,
e.g., cross-country shipments, manual vehicle temperature checks may be
made periodically during transit.
    We agree with comments that state that the proposed rule could be
interpreted to require continuous temperature monitoring during
transit, due in part to the proposed requirement at Sec.
1.908(d)(2)(i) that a carrier must, once the transportation operation
is complete, demonstrate to the shipper, and if requested, to the
receiver, that it maintained temperature conditions during the
transportation operation as specified by the shipper. We affirm that
the carrier bears the responsibility for demonstrating, when necessary,
that it transported food under appropriate temperature control
conditions consistent with those specified by the shipper. However, we
have revised this final rule at Sec.  1.908(e)(2) to allow that
demonstration to be made by any appropriate means agreeable to the
carrier and shipper, such as the carrier presenting recordings of the
ambient temperature of a trailer when it was loaded and unloaded, or in
the form of time/temperature data recorded during the shipment. This
revision also clarifies that we are not requiring that the carrier
conduct continuous monitoring of the temperature conditions on a
vehicle during transport, but it also recognizes that in some
circumstances it may be necessary to ensure the safety of the food and
that, in these circumstances, the shipper and carrier may agree to this
approach.
    We also considered circumstances in which it would be necessary for
a carrier to provide information to the shipper about temperature
conditions during shipment. We agree with comments that state that
requiring a carrier to routinely demonstrate for each delivered load
that it had met the shipper's temperature specifications is not
necessary for purposes of ensuring food safety and is not consistent
with current industry best practice. Therefore, we have revised this
rule at Sec.  1.908(e)(2) to provide that the carrier's demonstration
must be made only upon request by the shipper or the receiver. This
revision clarifies that a carrier is not required to routinely provide
this demonstration, but requires such a demonstration when, for
example, as explained below, the receiver assesses the food upon
receipt and determines that there may have been a material failure of
temperature control during the shipment, or when the shipper and
receiver have agreed that it is necessary to ensure the safety of the
food (e.g., some shipments of vacuum packaged seafood).
    We also considered what measures, if any, should be required after
a food transportation operation has been completed. Many of the
comments that we received observe that receivers currently routinely
check the function and settings of the transportation vehicle's
refrigeration unit and conduct visual inspections of the delivered food
products for which temperature control is required for signs of
temperature abuse. We regard these types of inspections as essential
for ensuring that the food was transported in accordance with
appropriate sanitary transportation practices and was not rendered
unsafe because of inadequate temperature control. Accordingly, we have
revised this final rule in Sec.  1.908(d), which now includes
requirements applicable to receivers, to provide that upon receipt of
food that requires temperature control, a receiver must take steps to
determine whether the food was subjected to significant temperature
abuse. We also have provided examples of measures a receiver could
employ for this purpose, such as determining the food product's
temperature, the ambient temperature of the vehicle and its
refrigeration unit's temperature settings and conducting a sensory
inspection to

ascertain whether there are signs of temperature abuse, such as off-
odor. We also note that the receiver at this stage may review
temperature monitoring information from an onboard temperature
monitoring device that might have been employed during the food
transportation process, and that such an approach would meet the
requirements of this rule.
    We also added a provision to the general requirements of this rule
Sec.  1.908(a)(6) that is applicable to circumstances in which
temperature abuse of a food may have occurred or another event may have
occurred that could have jeopardized the safety of the food (e.g.,
spillage of a toxic substance on food items in the same load). This
provision states that if a person subject to this rule becomes aware of
an indication of a possible material failure of temperature control or
other conditions that may render the food unsafe during transportation,
the person must take appropriate action, to ensure that the food is not
sold or otherwise distributed unless a determination is made by a
qualified individual, that the temperature deviation or other condition
did not render the food unsafe.
    This provision would, for example, require a receiver of food that
requires temperature control for safety, that has performed a check of
the vehicle compartment temperature as a way to comply with Sec.
1.908(d), and determined that the temperature is above the operating
temperature specified by the shipper, to hold the product until it can
make a determination that the temperature deviation did not make the
food unsafe. It could make that determination on its own, if it is
qualified to do so, or could consult with the carrier, loader, shipper,
or a third party to make such a determination or to assist it in making
such a determination. Whomever makes such a determination should be
qualified by training or experience to make such a determination, i.e.,
he should have a scientific understanding of how the temperature
deviation could affect the growth of pathogens or production of toxins
in the food. It is our expectation that, under such a circumstance, the
receiver (or shipper, if that is the more appropriate party to make the
determination) would request temperature control information from the
carrier. The carrier would be obligated to provide that information to
the shipper or receiver under the provisions of Sec.  1.908(e)(2).
    We have included in Sec.  1.908(a)(6) a provision that, if
requested by the receiver, the carrier must provide to the receiver the
operating temperature specified by the shipper in accordance with Sec.
1.908(b)(2). This is a necessary exchange of information to facilitate
the receiving examination provided for in Sec.  1.908(d), when the
receiver may not be aware of the operating temperature that the shipper
provided to the carrier.
    The new provision at Sec.  1.908(a)(6) would also, for example,
require the carrier of a food that notices leakage of liquid from boxes
of raw poultry onto partially enclosed crates of produce during a stop
in transportation to hold the food until the carrier can obtain a
determination from a qualified individual, e.g., the shipper, that the
condition did not cause the food to be unsafe for its intended use.
    We agree with the comments that we received that argued that if a
food has become unfit for its intended use because of material
temperature abuse during transportation, the food may still be fit to
an alternative use, such as for animal food. We would judge such
circumstances on a case-by-case basis.
    We have further modified the provisions of proposed Sec.
1.908(b)(3) (now Sec.  1.908(b)(2)) 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 pre-cooling 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 proposed phrase ``food that can
support the rapid growth of undesirable microorganisms in the absence
of temperature control during transportation, whether a TCS food or a
non-TCS food'' to ``food that requires temperature control for safety''
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)(5) of
this section to ensure that adequate temperature control is provided
during the transportation of food that requires temperature control for
safety.'' 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 temperature control 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 is operated during transportation
at a temperature that prevents the food from becoming unsafe 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 temperature conditions are met),
when that is consistent with the shipper's written SOPs, as provided
for in Sec.  1.908(b)(5). 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 temperature
control conditions for the railcar.
    (Comment 130) Several comments state that the proposed temperature
control requirements are excessive and inappropriate for the animal
food industry, and ask us to revise and better align them with risk-
based practices that are commonly used in that industry. One comment
states that refrigeration and temperature control are not relevant to
rendering industry ingredients because the high-temperature cooking
process of rendering destroys the pathogens contained in the raw
materials. Another comment states that maintaining temperature
conditions should only be considered when a firm has identified a
hazard that needs to be controlled.
    (Response 130) We have revised Sec.  1.908(a)(3), as we discussed
in our response to Comment 2, to clarify that the type of food
involved, for example, animal feed, pet food, human food, and the
food's given stage in the production process, for example, whether the
food is a raw material, an ingredient, or a finished food product, must
be considered when determining the conditions and controls, including
temperature controls, that may be necessary to ensure the sanitary
transportation of the food. We, therefore, agree that it would not be
necessary to provide temperature control during the transportation of
ingredients destined for rendering because these materials will
eventually be treated with high heat to destroy pathogens. As we have
previously stated, we have revised this final rule so that it focuses
entirely on food safety issues. For this reason, control of temperature
during transportation would not be required by the rule if

such control is not necessary to ensure its safety, e.g., where its
only purpose is to minimize decomposition of the food.
    (Comment 131) Two comments observe that the proposed rule does not
address the issue of how a shipment of food requiring temperature
control, for which a material failure of temperature control during
transport is suspected, should be handled. One of these comments
expresses the view that that the rule should remain silent on this
matter. The other comment argues that the issue is beyond the scope of
this rule and the matter would be best resolved by a risk assessment to
be conducted by the receiver and/or shipper.
    (Response 131) As we explained in our response to Comment 129, we
have revised Sec.  1.908(a)(6) of this final rule to require that if a
person subject to this rule becomes aware of an indication of a
possible material failure of temperature control or other conditions
that may render the food unsafe during transportation, the person must
take appropriate action, to ensure that the food is not sold or
otherwise distributed unless a determination is made by a qualified
individual, that the temperature deviation or other condition did not
render the food unsafe.
    While we agree that it is unnecessary to prescribe the details of
the mechanics of how such a determination is made, we do not agree that
the actions of a receiver after taking delivery of a food shipment that
may have been transported without appropriate temperature control, for
example, are beyond the scope of this rule. We are charged under the
2005 SFTA to establish sanitary transportation practices to be used by
shippers, carriers by motor vehicle or rail vehicle, receivers and
other persons engaged in the transportation of food to ensure that food
is not transported under conditions that may render it adulterated.
    As we discussed in our response to Comment 129, we revised Sec.
1.908(d) to establish duties for receivers of foods that require
temperature control because we have determined that they are essential
for ensuring that the food was transported in accordance with
appropriate sanitary transportation practices, consistent with industry
best practices. The new provisions at Sec.  1.908(a)(6) are an
appropriate extension of the provisions at Sec.  1.908(a)(6), in that
they ensure that the safety of the food is verified before a suspect
food is moved further in commerce.
    (Comment 132) A comment asserts that if a shipper is shipping a TCS
food product and holds it unrefrigerated on a dock before the food is
loaded into a transportation vehicle, the temperature of the product
will rise, which will increase the ambient temperature of the
refrigerated trailer compartment after the food is loaded, perhaps
causing a deviation from the shipper's temperature control
specifications. The comment argues that this outcome is completely
beyond the carrier's control and that it needs to be taken into account
when monitoring the temperature of the transportation vehicle
throughout the transport process.
    (Response 132) Under Sec.  1.908(a)(3)(iii), persons subject to
this rule must ensure that food that requires temperature control to
prevent it from becoming adulterated during transportation is
transported under adequate temperature control. This requirement also
applies to the holding of food on a loading dock. Responsibility for
complying with this requirement resides with the loader and not with
the carrier. Although this rule does not require the use of temperature
controlled loading docks, it does require that the loader handle food
that requires refrigeration for safety in such a way that will prevent
it from becoming unsafe. This may be accomplished by a loader by, for
example, rapidly moving the refrigerated product from its refrigerated
storage to a precooled vehicle, or by temporarily holding the
refrigerated product in a refrigerated loading dock prior to loading
onto a precooled vehicle backed up to the loading dock.
    (Comment 133) Several comments ask us to clarify that the written
temperature condition specifications that shippers must provide to
carriers can appear in existing documents, such as contracts or bills
of lading, and that they do not have to be conveyed by shippers to
carriers in new, separate, dedicated documents.
    (Response 133) We agree. The shipper may meet the requirements of
Sec.  1.908(b)(2) by communicating written information to the carrier
in the form of existing contracts or bills of lading. Shippers do not
need to create new, separate written temperature conditions
specification documents for transmittal to carriers.
    (Comment 134) Some comments state that the proposed rule can be
interpreted to require pre-cooling only when it is necessary to
maintain temperature conditions during transport, and ask us to clarify
this point. One comment, for example, states that pre-cooling may not
be required for transportation during the winter in cold areas or for
short distance transportation of food.
    (Response 134) We did not intend to suggest in the proposed rule
that a shipper must always provide pre-cooling parameters to a carrier
for the transportation of foods subject to the temperature control
requirements of this rule. We agree that pre-cooling may not be
required for transportation operations conducted during winter in cold
areas or for short distance transportation of food in appropriate
circumstances. Under this rule, the shipper must determine whether pre-
cooling a vehicle or transportation equipment by the carrier is
necessary for the sanitary transportation of the food being shipped. We
have revised Sec.  1.908(b)(2) to clarify this point by specifying that
the shipper must provide pre-cooling specifications to the carrier and
when necessary, to the loader (e.g., if the shipper is not also the
loader), only if the shipper deems this step to be necessary to ensure
that the transportation operation will be conducted under such
conditions and controls necessary to prevent the food from becoming
unsafe.
    (Comment 135) One comment states that pre-cooling transportation
equipment is inadequate without pre-cooling the product. The comment
singles out RACs as an example, noting that if the RACs are not
adequately pre-cooled prior to transportation, they will cause the
temperature of the pre-cooled carrier container to rise above the
specified temperature limits, thereby potentially creating conditions
for bacterial growth. Another comment asks us to modify the language of
this rule to clarify that it does not prevent the loading of harvested
RACs directly from the field into pre-cooled trailers provided by
carriers. This comment states that although under these circumstances,
the temperature in the trailer will increase after is has been loaded,
this is still a beneficial practice because it begins decreasing the
field heat of RACs as soon as possible. The commenter asks us to allow
this practice to continue even though it may not be possible for a
carrier operating under these circumstances to meet the proposed
requirement that the carrier follow the shipper's temperature controls.
    (Response 135) Under Sec.  1.908(a)(3) of this rule, all
transportation operations must be conducted under such conditions and
controls necessary to prevent the food from becoming unsafe. In
addition, it is the shipper's responsibility under Sec.  1.908(b)(2)
(revised from proposed Sec.  1.908(b)(3)) to specify to the carrier
and, when necessary, the loader, whether pre-cooling a vehicle or
transportation

equipment is necessary for purposes of compliance with this rule. We
have added the term ``if necessary'' to the pre-cooling provision of
Sec.  1.908(b)(2) to clarify that we are not requiring pre-cooling in
all circumstances. If pre-cooling the food product is necessary to meet
the requirements of this rule, we would expect that the shipper and the
loader would ensure that this step is effectively applied as part of
their responsibilities under this rule. As we discuss in our response
to Comment 129, however, we have made it clear in this rule, as
revised, that we are not requiring shippers to specify temperatures to
carriers and loaders that would be regarded as critical limits for food
safety purposes. Accordingly, an increase in the temperature of the
food compartment of a pre-cooled vehicle after products that have not
been pre-cooled have been loaded into the compartment would not
necessarily be of concern, as long as the temperature control measures
applied during the operation ensure that the food will not become
unsafe during transportation. Finally, nothing in this rule
specifically precludes the loading of harvested RACs directly from the
field into pre-cooled trailers provided by carriers because most RACs
are refrigerated during transportation to minimize spoilage and not to
ensure their safety. Exceptions include seed sprouts and raw molluscan
shellfish.
    (Comment 136) Some comments ask us to acknowledge that pre-cooling
procedures should account for the potential for condensation formation
during loading operations. One of these comments states that a transit
container should be pre-cooled only if it is connected to a cold
storage unit because product temperature and container temperature need
to be in equilibrium to prevent hotter air from entering the container
when its doors are opened during loading. The entry of hotter air into
the container causes condensation, which can create a number of
problems, including the formation of ice and structural damage to
shipping containers.
    (Response 136) Under Sec.  1.908(a)(3) of this rule, all
transportation operations, including loading operations, must be
conducted under such conditions and controls as necessary to prevent
the food from becoming unsafe. It is the shipper's responsibility under
Sec.  1.908(b)(2) to specify to the carrier whether pre-cooling a
vehicle or transportation equipment is necessary for purposes of
complying with this rule. We would expect that, if necessary under the
requirements of this rule, the shipper (who is often also the loader),
and the loader (if the loader is a different entity), will follow
appropriate procedures to address the formation of condensation during
the loading of a pre-cooled vehicle.
    (Comment 137) One comment expresses the view that the carrier needs
to have unambiguous notice that it is being tendered a shipment of food
that is not shelf stable and that such notices should be uniform and
clearly noted in shipping documents so the carrier can make an informed
decisions regarding the handling of the shipment. Another comment
recommends that the carrier should be notified in writing when a
shipment includes a TCS food.
    (Response 137) As we have previously stated, this final rule is
focused only on food safety, and we have accordingly revised language
that previously referred to ``foods that are not shelf stable'' to
``foods that require refrigeration for safety.'' We are using the
latter term instead of the term TCS food. We agree that it is
imperative that a carrier that takes responsibility for ensuring that a
food that requires refrigeration for safety be informed by the shipper
the operating temperature of the vehicle that is necessary to safely
transport the food. Such disclosure is now required by revised Sec.
1.908(b)(2).
    (Comment 138) One comment asserts that thermally insulated tankers
should be pre-cooled after a high temperature wash. The comment is
concerned that the contents of the tanker would increase in temperature
if a tanker is not pre-cooled. The comment suggests removing the
exclusion for a carrier who transports food in a thermally insulated
tank from the requirement of proposed 1.908(b)(3).
    (Response 138) We decline this request. It is our understanding
that it is a common industry practice to clean thermally insulated
tankers right after unloading products rather than immediately before
loading. The practice would allow the tankers to cool down after a hot
temperature wash. Even if a product is loaded into a thermally
insulated tanker that has just been cleaned with a high temperature
wash, considering the small surface to volume ratio, we do not believe
that the product temperature would be raised to a degree that is
significant with respect to the maintenance of appropriate temperature
control.
    In addition, thermally insulated tankers are designed and built to
limit the degree of temperature increase of a food in a given amount of
time. Therefore, we are retaining the exclusion relating to food in a
thermally insulated tank from the requirement of 1.908(b)(3).
d. New Sec.  1.908(b)(3) to (5)
    Many of the previously discussed comments depicted a food
transportation system that is highly diverse, with shippers, receivers,
loaders, and carriers developing and implementing food safety controls
that are tailored to their specific circumstances. These controls take
into account the nature of the food (e.g., ready-to-eat vs. RACs for
further processing, animal feed vs. human food), the manner of
transportation (e.g., motor freight vs. rail freight), the nature of
the transportation vehicle (e.g., owned or leased by the shipper,
receiver or carrier, tanker vs. hopper vs. boxcar, refrigerated vs.
unrefrigerated), the location and distance between shipper and
receiver), the relationship between the shipper and the carrier (e.g.,
simply providing a working boxcar to providing full service
transportation including temperature control assurance), and the
involvement of third parties (e.g., brokers, contract loaders at remote
sites), among other factors. Many comments urged flexibility to allow
the best practices that have evolved over time for these various
scenarios to continue to be implemented as long as they are effective
in assuring food safety. Perhaps the starkest differences raised in the
comments were between common practices in the motor freight and rail
freight sectors. Notwithstanding those differences, some members of the
rail freight sector informed us that they operated in a manner similar
to many of those in the motor freight sector (for example, providing
services such as refueling and monitoring refrigerated units and
arranging for cleaning of bulk cargo cars), and vice versa. These
commenters argued that assigning specific duties to specific categories
of entities (e.g., shippers, carriers, even within a sector) could, in
many cases, have the effect of making some arrangements that have
worked over time difficult or impossible.
    We acknowledge this diversity and agree that the final rule should
be structured to accommodate it. We also agree that the rule should be
structured as much as possible so as not to restrict innovation in the
relationships between the parties covered by the rule. On the other
hand, we are compelled to develop a rule that is not so fluid that it
is unenforceable. Especially when things go wrong, it is important to
know who is responsible for what functions and to be able to hold them
accountable. Even during day to day operations, it is important for the
interacting parties to know where they are responsible and the
responsibilities of the other parties,

in order that all parties understand their roles and are sufficiently
motivated to accomplish their piece of the system.
    In response to Comment 70, we have explained our thinking relative
to the revised definition of shipper, which reads, ``a person who
arranges for the transportation of food by a carrier or multiple
carriers sequentially.'' We explained that we have concluded that this
is the entity that is in the best position to determine the necessary
conditions for safe transportation of food. Further, this is the party
that causes the food to move in commerce, and, as a result, we believe,
should bear the burden of setting out the safe conditions for that
movement and assuring that they are met. As a result of these
determinations, we have concluded that the shipper should be charged by
this rule with developing and implementing written procedures that
address how the safety of the food will be assured relative to the
three major focus areas of this rule, to the extent that they apply to
the foods that they ship. The three major focus areas are: (1)
Assurance that vehicles and equipment used in its transportation
operations are in appropriate sanitary condition; (2) assurance that,
for bulk cargo, a previous cargo does not make the food unsafe; and (3)
assurance that, for foods that require refrigeration for safety, the
food is transported under adequate temperature control. It is necessary
for these procedures to be in writing in order to facilitate consistent
implementation by the shipper, especially with changes in personnel,
and to provide for effective enforcement by FDA and other regulatory
agencies. We expect that shippers would maintain such written
procedures to facilitate their operations.
    We recognize that, while the shipper is charged with developing and
implementing these procedures, in many scenarios the shipper will need
to secure the services of other parties, such as the receiver, loader,
or carrier, to accomplish some or all of the measures. We expect that
those services will be secured under a written agreement, subject to
the records requirements of Sec.  1.912(a). It is necessary for these
agreements to be in writing in order to facilitate a consistent
understanding of responsibilities and consistent implementation of the
provisions by the shipper, carrier, loader and receiver, and to provide
for effective enforcement by FDA and other regulatory agencies. Again,
it is our understanding, based in part on comments discussed earlier in
this document, that such agreements, usually in the form of contracts,
are consistent with industry best practice.
    Consequently, we have added three new sections to the proposed rule
at Sec.  1.908(b)(3) to (5). These new sections require that:
     A shipper must develop and implement written procedures,
subject to the records requirements of Sec.  1.912(a), adequate to
ensure that vehicles and equipment used in its transportation
operations are in appropriate sanitary condition for the transportation
of the food, i.e., that will prevent the food from becoming unsafe
during the transportation operation. Measures to implement these
procedures may be accomplished by the shipper or by the carrier or
another party covered by this rule under a written agreement, subject
to the records requirements of Sec.  1.912(a).
     A shipper of food transported in bulk must develop and
implement written procedures, subject to the records requirements of
Sec.  1.912(a), adequate to ensure that a previous cargo does not make
the food unsafe. Measures to ensure the safety of the food may be
accomplished by the shipper or by the carrier or another party covered
by this rule under a written agreement, subject to the records
requirements of Sec.  1.912(a).
     The shipper of food that requires temperature control for
safety under the conditions of shipment must develop and implement
written procedures subject to the records requirements of Sec.
1.912(a), to ensure that the food is transported under adequate
temperature control. Measures to ensure the safety of the food may be
accomplished by the shipper or by the carrier or another party covered
by this rule under a written agreement, subject to the records
requirements of Sec.  1.912(a), and must include measures equivalent to
those specified for carriers under Sec.  1.908(e)(1) to (3).
    We proposed at Sec.  1.908(b)(5) that the shipper assumes the
requirements applicable to the carrier in Sec.  1.908(d)(2)(i) with
respect to providing a demonstration to the receiver if the shipper and
carrier have agreed in writing under Sec.  1.908(d)(2)(ii) that the
shipper is responsible for ensuring that the food was held under
acceptable temperature conditions during transportation operations.
When the shipper and carrier have established such an agreement, the
shipper also assumes the corresponding records requirements of
Sec. Sec.  1.908(d)(6)(ii) and 1.912(b). This provision was proposed to
provide flexibility in the manner in which temperature control was
assured during transportation, and, in particular, who was responsible
for demonstrating to the receiver that such control was maintained.
This provision is no longer necessary, and has been deleted from the
final rule, because the new provision at Sec.  1.908(b)(5) provides the
same kind of flexibility for temperature control assurance, for foods
that require refrigeration for safety, as discussed earlier in this
document.
3. Requirements Applicable to Shippers and Receivers Engaged in
Transportation Operations (Proposed Sec.  1.908(c))
    We had proposed to establish requirements for shippers and
receivers addressing food handling during loading and unloading, in
proposed Sec.  1.908(c). As we discuss in this section, we have
determined that it is not necessary to include these requirements, as
they were proposed, in this final rule. We have redesignated Sec.
1.908(c) in this final rule to specify requirements applicable to
loaders engaged in transportation operations, which we discuss in the
following section.
    (Comment 139) One comment states that we should ensure that
receivers have the ability to test a food product before automatically
discarding it because the shipper's temperature control specifications
were exceeded during transport.
    (Response 139) Nothing in this rule requires receivers to discard
food if the food was subject to deviations from a shipper's temperature
control specifications during transport. We discuss a receiver's
responsibilities for handling food that requires temperature control in
our response to Comment 129.
    (Comment 140) Several comments oppose proposed Sec.  1.908(c)(1) on
the grounds that the provision would be unnecessarily burdensome and
would not improve food safety or otherwise contribute to the sanitary
transportation of food.
    One comment states that foods that are shipped without being
completely enclosed in packaging, such as RACs, are freely handled by
consumers when offered for sale in retail establishments. The comment
notes that no rule currently requires consumers to wash their hands
prior to the handling these foods and that there is no evidence to
suggest that transportation vehicle operators present a greater risk of
contaminating food not completely enclosed in packaging than do a food
retailer's employees or consumers who also handle these food products
prior to consumption. The comment also argues that while our proposed
rule compares Sec.  1.908(c)(1) to requirements in the cGMP regulations
for human food, particularly 21 CFR 110.10(b), they are

not the same (the cGMP regulations for human food have been revised in
the preventive controls for human food final rule and are now in 21 CFR
part 117, subpart B). The commenter notes that 21 CFR 110.10(b)
generally requires all persons who work in direct contact with food to
conform to hygienic practices to the extent necessary to protect
against food contamination. According to the comment, the proposed hand
washing provision in this rule does not contemplate that the
requirement might not be necessary to protect against contamination
given the existing cGMP hygienic practices provisions.
    Other comments argue that proposed Sec.  1.908(c)(1) should only
apply if the vehicle operator is reasonably expected to come in
physical contact with the food. One comment asserts that this proposed
requirement lacks supporting scientific data, is unnecessary, is not
feasible in many instances, and would appear to be appropriate only if
human contact with the food poses a risk that the food will become
adulterated or otherwise poses a valid health risk to humans or
animals. Another comment recommends that any requirement for hand-
washing facilities be risk-based and be linked directly to the
effectiveness of hand-washing for purposes of reducing the risk that
human handling of food would cause the food to be rendered injurious to
health or otherwise adulterated.
    Another comment suggests that firms should train drivers with
respect to safe handling practices and that we should leave the
selection of the sanitary methods for the handling of foods not
entirely enclosed by packaging up to the transportation firms. The
comment suggests, for example, that vehicle operators may be instructed
to use disposable gloves, sanitary wipes, and/or a customer's hand
washing facilities depending on the circumstances. One comment
expresses concern that this provision would require the installation of
additional sinks in virtually all food distribution centers at a great
cost to the industry.
    (Response 140) After considering these comments, we have decided to
remove the provision in proposed Sec.  1.908(c)(1) from this final
rule. We have determined that this provision is unnecessary because the
specific circumstance that proposed Sec.  1.908(c)(1) would address,
vehicle operators handling food not completely enclosed by a container,
is already addressed by the broader requirement of Sec.  1.908(a)(3),
which requires that all transportation operations be conducted under
such conditions and controls necessary to prevent the food from
becoming unsafe during transportation operations. In particular, Sec.
1.908(a)(3)(ii) includes hand washing as an example of measures that
can be taken to protect food transported in bulk vehicles or food not
completely enclosed by a container from contamination and cross-contact
during transportation operations. Providing vehicle operators access to
hand washing facilities is one method for preventing the contamination
of food, but we agree that it may not always be necessary. By removing
proposed Sec.  1.908(c)(1) from this rule, we are allowing flexibility
for the transportation industry to determine what control measures
would be necessary in any given set of circumstances.
    Furthermore, we have reached the same conclusion concerning the
provision in proposed Sec.  1.908(c)(2), which would have required
shippers and receivers of food that can support the rapid growth of
undesirable microorganisms in the absence of temperature control during
transportation, to carry out loading and unloading operations under
conditions that would ``prevent the food from supporting such microbial
growth.'' We have removed that provision from this final rule because
our expectations for temperature control during loading and unloading
operations are set forth in new Sec.  1.908(a)(3)(iii), which requires
persons subject to this rule to take effective measures to ensure that
food that requires temperature control for safety is transported under
adequate temperature control; see Comment 132 and Comment 141.
    (Comment 141) One comment states that there are no provisions in
the rule to ensure that insanitary conditions have not contaminated the
food before a carrier becomes involved. The comment asserts that the
rule does not require specifications for conditions that must be
maintained on loading and unloading docks, and that carriers are not
given an opportunity to inspect and confirm either the condition of the
cargo or the facilities where the food is picked-up or delivered.
    (Response 141) We disagree with the comment. The requirements of
Sec.  1.908(a)(3) and (c), while general in nature, address sanitary
transportation practices applicable to the loading and unloading of
food. In addition, this rule does not preclude a carrier from
establishing agreements with the owner or operator of the facility or
loading dock to inspect or confirm the condition of cargo or facilities
prior to accepting a load.
4. Requirements Applicable to Loaders Engaged in Transportation
Operations (New Sec.  1.908(c))
    As we stated in the previous section, we have redesignated Sec.
1.908(c) in this final rule as, ``Requirements applicable to loaders
engaged in transportation operations.'' The provisions we have included
in this section arise from our consideration of comments relevant to
loading operations in other sections of this final rule; see Comment
125, Comment 126, Comment 127, Comment 128, and Comment 129.
5. Requirements Applicable to Receivers Engaged in Transportation
Operations (New Sec.  1.908(d))
    We have established requirements applicable to receivers engaged in
transportation operations in Sec.  1.908(d) of this final rule and have
moved the corresponding requirements applicable to carriers (proposed
Sec.  1.908(d)) to new Sec.  1.908(e), discussed in the following
section. The provisions we have included in new Sec.  1.908(d) arise
from our consideration of comments relevant to food that requires
temperature control for safety, which we discuss in Comment 129.
6. Requirements Applicable to Carriers Engaged in Transportation
Operations (Proposed Sec.  1.908(d), Now New Sec.  1.908(e))
    As discussed in section IV.E.2, we have concluded that the shipper
should be charged by this rule with developing and implementing written
procedures that address how the safety of the food will be assured
relative to the three major focus areas of this rule, to the extent
that they apply to the foods that they ship. The three major focus
areas are: (1) Assurance that vehicles and equipment used in its
transportation operations are in appropriate sanitary condition; (2)
assurance that, for bulk cargo, a previous cargo does not make the food
unsafe; and (3) assurance that, for foods that require refrigeration
for safety, the food is transported under adequate temperature control.
We recognize that, while the shipper is charged with developing and
implementing these procedures, in many scenarios the shipper will need
to secure the services of other parties, such as carrier, to accomplish
some or all of the measures. We expect that those services will be
secured under a written agreement, subject to the records requirements
of Sec.  1.912. It is our understanding, based in part on comments
discussed earlier in this document, that such agreements,

usually in the form of contracts, are consistent with industry best
practice.
    Consequently, we have added three new sections to the proposed rule
at Sec.  1.908(b)(3) to (5). These new sections require that:
     A shipper must develop and implement written procedures
subject to the records requirements of Sec.  1.912(a), adequate to
ensure that vehicles and equipment used in its transportation
operations are in appropriate sanitary condition for the transportation
of the food, i.e., that will prevent the food from becoming unsafe
during the transportation operation. Measures to implement these
procedures may be accomplished by the shipper or by the carrier or
another party covered by this rule under a written agreement subject to
the records requirements of Sec.  1.912(a).
     A shipper of food transported in bulk, must develop and
implement written procedures subject to the records requirements of
Sec.  1.912(a), adequate to ensure that a previous cargo does not make
the food unsafe. Measures to ensure the safety of the food may be
accomplished by the shipper or by the carrier or another party covered
by this rule under a written agreement subject to the records
requirements of Sec.  1.912(a).
     The shipper of food that requires temperature control for
safety under the conditions of shipment must develop and implement
written procedures subject to the records requirements of Sec.
1.912(a), to ensure that the food is transported under adequate
temperature control. Measures to ensure the safety of the food may be
accomplished by the shipper or by the carrier or another party covered
by this rule under a written agreement subject to the records
requirements of Sec.  1.912(a) and must include measures equivalent to
those specified for carriers under Sec.  1.908(e)(1) to (3).
    Consistent with these new provisions in the previous section
applicable to requirements for shippers, we have included language at
Sec.  1.908(e) (proposed Sec.  1.908(d)) that makes the provisions of
that section applicable to a carrier only when the carrier and shipper
have a written agreement that the carrier is responsible, in whole or
part, for sanitary conditions during the transportation operation. Each
provision is applicable only when it is relevant to the provisions of
the agreement between the carrier and the shipper. For example, the
carrier and the shipper may have a written agreement that states that
the carrier is to precool the vehicle and set and monitor operating
temperatures in the vehicle, based on instructions from the shipper. In
this case, the carrier would be responsible for meeting the
requirements of Sec.  1.908(e) that are relevant to temperature control
(i.e., Sec.  1.908(e)(2) and (3), discussed in this document). If the
agreement did not assign responsibility for other sanitary conditions
to the carrier, e.g., cleanliness of the vehicle, previous cargo
control, the other provisions of Sec.  1.908(e) would not be applicable
to the carrier.
a. Proposed Sec.  1.908(d)(1)
    We proposed to require that a carrier must supply a vehicle and
transportation equipment that meets any requirements specified by the
shipper in accordance with Sec.  1.908(b)(1), and is otherwise
appropriate to prevent the food from becoming filthy, putrid,
decomposed or otherwise unfit for food, or being rendered injurious to
health from any source during the transportation operation.
    We have made the following revision to proposed Sec.  1.908(d)(1)
(now Sec.  1.908(e)(1)) for consistency with changes elsewhere in the
final rule to focus the rule on food safety only. 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.''
    (Comment 142) One comment asks us to require LTL carriers to
implement written procedures to ensure the compatibility of each food
contained within an LTL load and to require that the carrier be able to
demonstrate full compliance with each shipper's food transportation
specifications upon request.
    (Response 142) We decline to make this change. We have assigned
responsibility for ensuring that a vehicle onto which food not
completely enclosed by a container is loaded is in appropriate sanitary
condition, to the loader, giving consideration to specifications
provided by the shipper (see Comment 70). Among other factors, the
loader is to consider whether the vehicle is in adequate physical
condition and whether it is free of visible evidence of pest
infestation and previous cargo that could cause the food to become
unsafe. In the case of an LTL load, we would expect that the loader
would check to see if any previously loaded cargo could potentially
contaminate food not completely enclosed by a container in a subsequent
load. We would also expect that the shipper of food not completely
enclosed by a container on an LTL load would generally instruct the
loader to inspect (where the loader and the shipper are not the same
person), consistent with the shipper's obligations under Sec.
1.908(b)(3).
    (Comment 143) Another comment notes that the carrier has the
responsibility for providing a container in good mechanical condition
and that is reasonably clean of dirt, debris and foul odors. However,
the comment states that the shipper should be responsible for any
``sanitizing'' that might be required for the sanitary transportation
of a particular food/beverage or commodity.
    (Response 143) We are aware that, depending upon the circumstances
and the agreement between the parties, current practice is that either
shippers, loaders or carriers may wash and/or sanitize vehicles before
they are loaded, or they may contract with a third party to perform
that function. We see no public health benefit in changing current
practice by mandating that one party or another perform the function.
As previously discussed, in new Sec.  1.908(b)(3) we have required that
shippers develop and implement written procedures specifying how they
will ensure that vehicles and equipment used in its transportation
operations are in appropriate sanitary condition for the transportation
of the food. We would expect such procedures to include cleaning and
sanitizing procedures as appropriate to the food and conditions of
shipment. However, new Sec.  1.908(b)(3) also provides that the shipper
may reach an agreement with the carrier, or another party covered by
this rule, to perform this function. If a carrier agrees to perform
this function, Sec.  1.908(e)(1) requires that they ensure that the
vehicle meets the shippers specifications in that regard.
    (Comment 144) One comment states that some jurisdictions prohibit
carriers from washing out their truck's trailers because of local water
quality regulations designed to protect the environment from
contaminated water runoff. The comment further asserts that this rule,
therefore, places carriers in the untenable position of having to
choose which regulation to follow. The comment asks us to provide
clarity regarding the interaction between this rule and state and local
regulations that may restrict or prohibit truck washing.
    (Response 144) This rule is not intended to preempt state and local
requirements regarding water runoff and water quality issues that would
affect truck washing. Carriers affected by local requirements that
restrict or prohibit truck washing must, even now, determine how to
meet any

requirements imposed upon them by their shipper customers when faced
with local washing restrictions. This rule does not change that fact.
As discussed in response to the previous comment, in new Sec.
1.908(b)(3) we have required that shippers develop and implement
written procedures specifying how they will ensure that vehicles and
equipment used in their transportation operations are in appropriate
sanitary condition for the transportation of the food. We would expect
such procedures to include cleaning and sanitizing procedures as
appropriate to the food and conditions of shipment. However, new Sec.
1.908(b)(3) also provides that the shipper may reach an agreement with
the carrier, or another party covered by this rule, to perform this
function. If a carrier agrees to perform this function Sec.
1.908(e)(1) requires that they ensure that the vehicle meets the
shippers specifications in that regard. In some cases the shipper may
choose to perform the function, if it has facilities to do so.
b. Proposed 1.908(d)(2)
    We proposed to require that a carrier must, once the transportation
operation is complete, demonstrate to the shipper and if requested, to
the receiver, that it has maintained temperature conditions during the
transportation operation consistent with those specified by the shipper
in accordance with Sec.  1.908(b)(3). We proposed that these
demonstrations may be accomplished by any appropriate means agreeable
to the carrier and shipper, such as the carrier presenting printouts of
a time/temperature recording device or a log of temperature
measurements taken at various times during the shipment. We also
proposed that a carrier would not be subject to the requirement of
Sec.  1.908(d)(2)(i) if the carrier and shipper agree in writing,
before initiation of the transportation operations, that the shipper
would be responsible for monitoring the temperature conditions during
the transportation operation or otherwise ensuring that the food was
held under acceptable temperature conditions during the transportation
operation. Finally, we proposed that a carrier must provide the written
agreement to the receiver, if requested, and that this written
agreement would be subject to the records requirements of Sec.
1.912(b).
    Consistent with our discussion concerning the duties of the shipper
as a result of the requirements of Sec.  1.908(b)(5), we have removed
the provisions of proposed Sec.  1.908(d)(2)(ii), concerning
alternative arrangements for the responsibility to provide temperature
control information to the shipper and receiver. This provision is no
longer needed because new Sec.  1.908(b)(5) and the new language at new
Sec.  1.908(e) provide the same flexibility to assign responsibility
for this function as was provided by proposed Sec.  1.908(d)(2)(ii).
    (Comment 145) One comment asserts that an LTL carrier should have
the flexibility to deviate from the temperature specified by the
shipper when transporting mixed loads that contain food from more than
one shipper. The comment further asserts that we should allow LTL
carriers to set temperatures for such mixed loads based on the lowest
temperature needed to safely transport TCS foods in any given load,
even though this temperature may differ from that specified by any of
the other LTL shippers.
    (Response 145) We agree with the comment. Our expectation is that,
generally, each of the shippers of food that require temperature
control for safety in an LTL load would provide an operating
temperature to the carrier. These temperatures represent temperatures
that will ensure that the food does not become unsafe during
transportation. In most cases, they will also assure marketability and
quality preservation, as desired by the shipper. With regards to the
requirements of this regulation, if a carrier who has accepted
responsibility for temperature control during transit selects the
coldest temperature of those provided by the shippers they will be
meeting their responsibility under Sec.  1.908(e)(2). However, we note
that there may be times when a shipper does not want their product to
be exposed to excessively cold temperatures for quality reasons. In
this case, the shipper would be well advised to so instruct the
carrier. We would consider such instructions to be outside the scope of
this regulation as they do not impact food safety.
    (Comment 146) Another comment asks us to develop and require
carriers to adhere to air and product temperature-monitoring standards
to meet the requirements specified by the shipper under proposed Sec.
1.908(b)(3). The comment asserts that these requirements should include
adequate and sanitary representative sampling methods, address
appropriate temperature measurement device placement, and consider the
effects of load configurations and other contributing factors on
temperature control during transportation. The comment asks us to
consider the potential need for shippers to require both air and
product temperature monitoring and recommends that any requirements
related to verification of product temperatures should be incorporated
in a manner that would not involve undue or burdensome costs.
    (Response 146) We do not agree. We think these types of detailed
provisions are better for guidance than for regulations. Because of the
diversity of transportation operations, including the variety of foods
transported, we have concluded that shippers need to be given
considerable latitude to develop temperature controls for their
operations, as long as they do, in fact, serve to prevent the food from
becoming unsafe during transportation. Some of the recommendations
contained in the comment, e.g., a requirement to monitor both air and
product temperature, would, in many cases, establish a level of
temperature control substantially more rigorous than current best
industry practices, which have proven to be effective in providing for
sanitary food transportation and which we have incorporated into this
final rule.
c. Proposed Sec.  1.908(d)(3)
    We proposed to require that, before offering a vehicle or
transportation equipment with an auxiliary refrigeration unit for use
for the transportation of food that can support the rapid growth of
undesirable microorganisms in the absence of temperature control, a
carrier must precool each mechanically refrigerated freezer and cold
storage compartment as specified by the shipper in accordance with
paragraph (b)(3) of this section.
    We have made the following revisions to proposed Sec.  1.908(d)(3)
(now Sec.  1.908(e)(3)) for consistency with changes elsewhere in the
final rule to focus the rule on food safety only. We have changed the
proposed phrase ``food that can support the rapid growth of undesirable
microorganisms in the absence of temperature control'' to ``food that
requires temperature control for safety.'' We have also removed the
word ``freezer,'' because we believe that the pre-cooling of freezer
vehicles is a step taken to preserve product quality and marketability
and not to prevent the food from becoming unsafe.
d. Proposed Sec.  1.908(d)(4)
    We proposed to require that a carrier that offers a bulk vehicle
for food transportation must provide information to the shipper that
identifies the three previous cargoes transported in the vehicle. We
proposed that the shipper and carrier would be able to agree in writing
that the carrier would provide information identifying fewer than three

previous cargoes, or that the carrier would not need to provide any
such information if procedures have been established that would ensure
that the bulk vehicle being offered would be adequate for the intended
transportation operation, for example, if the carrier by contract would
agree to offer vehicles dedicated exclusively to transporting a single
type of product. We also proposed that the written agreement would be
subject to the records requirements of Sec.  1.912(b).
    Consistent with our discussion concerning the duties of the shipper
as a result of the requirements of Sec.  1.908(b)(4), we have removed
the provisions of proposed Sec.  1.908(d)(4), concerning alternative
arrangements for the responsibility to provide previous cleaning
information to the shipper. This provision is no longer needed because
new Sec.  1.908(b)(4) and the new language at new Sec.  1.908(e)
provide the same flexibility to assign responsibility for this function
as was provided by proposed Sec.  1.908(d)(4).
    (Comment 147) A few comments support this proposed provision. One
comment notes that the proposed requirement is an existing common
industry practice. Another comment informs us that our proposal is
feasible. Another comment expressed the view that requiring
identification of the three previous loads hauled is excessive and
unnecessary for accomplishing the goal of sanitary food transport.
    Several comments state that it is currently common for carriers to
provide information about the single previous cargo hauled on a bulk
transport vehicle to shippers under procedures already in place and
widely accepted within both the human and animal food transportation
industries. One of these comments states that for shippers, knowing the
immediately previous load hauled in a bulk conveyance and knowing
whether appropriate clean-out procedures have been followed, if needed
to ensure the conveyance meets the needs of the shipper based upon the
type of food to be loaded, is critically important. Another comment
states that knowing what type of feed was hauled in a dedicated truck
immediately before the present load is useful information when
assessing the possibility of the contamination of the present load.
Another comment offers the view that the shipper, in accordance with
the FSMA preventive controls rules, would maintain written procedures
as part of its food safety plan to ensure adequate cleanout of vehicles
is performed and documented. According to this commenter, this written
plan should suffice in lieu of any additional documentation required to
support compliance to this rule.
    Another comment states that the request for three previous cargoes
is impractical for LTL shipments, where tractors hauling trailers with
packaged goods may stop at multiple locations to pick up shipments.
Several comments assert that the carrier's release of information
regarding multiple previous loads could result in the improper
disclosure of sensitive business information because it could involve
divulging to a shipper's competitors detailed information regarding the
shipper's deliveries to their customers. A related comment asserts that
the tracking of three previous cargoes is impractical, and perhaps
impossible, because trailers are attached to tractor transportation
vehicles on a continually changing basis.
    (Response 147) These comments indicate that under current industry
practices, in some cases, shippers acquire information from carriers
about cargo previously transported in a bulk vehicle and that this
information has value to them in ensuring that their cargo will not be
at risk of contamination during transportation. In other cases,
shippers do not seek to obtain this information and instead rely on
other measures to ensure that contamination will not occur, such as
guarantees that the carrier will provide a vehicle dedicated to
transporting a single type of cargo. Further, we have concluded that
such a common practice demonstrates that this provision would not
adversely impact businesses because of concerns about the disclosure of
sensitive business information.
    However, none of the comments supported the need to identify more
than the single previous shipment and some suggest that it would be
unduly burdensome. We are persuaded by these comments, and,
consequently, while we have retained proposed Sec.  1.908(d)(4) (new
Sec.  1.908(e)(4)), we have revised it to require the carrier to
provide, on request from the shipper (when such function is the subject
of a written agreement between the shipper and the carrier as provided
for under Sec.  1.908(b)(4)), information about the last previous cargo
transported in a bulk vehicle. With respect to LTL shipments, we note
that this provision does not apply in circumstances where the vehicle
is used to transport packaged goods. This provision only applies to
vehicles in which food is shipped in bulk, with the food coming into
direct contact with the inner surfaces of the vehicle.
    (Comment 148) A comment asks us to exempt vehicles that transport
raw materials to rendering operations from the requirement of
identifying prior cargoes.
    (Response 148) While we recognize that materials destined for
rendering will receive a heat treatment to destroy pathogens, we are
not exempting carriers from the requirement that they identify the
vehicle's previous cargo to the shipper supplying raw materials to a
rendering operation because the shipper might wish to determine whether
the bulk vehicles carried some previous cargoes that could contaminate
the raw material in a way that would not be addressed by the heat
processes of the rendering operation (e.g., heat stable chemical
contaminants). We are retaining this provision to allow the shipper to
obtain this information from the carrier, if the shipper deems it
necessary for the purposes of ensuring that his product does not become
unsafe during transportation.
    (Comment 149) Another comment asserts that carriers that offer bulk
food vehicles for food transportation already comply with comparable
requirements under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (the Bioterrorism Act), and
further asserts that compliance with these existing requirements is
sufficient to protect food safety during transportation operations.
    (Response 149) We disagree. We have not established requirements in
any other regulations that carriers must provide information to
shippers that identifies previous cargoes transported in bulk vehicles
or that describes the most recent cleaning of the vehicle. We are
establishing these requirements in this rule pursuant to the objective
of this rulemaking, which is to require that persons engaged in the
transportation of food use sanitary transportation practices to ensure
that food does not become unsafe during transportation. The regulations
we have established under the Bioterrorism Act, as they pertain to food
transportation, address a different purpose. Those regulations in 21
CFR part 1 address records that must be kept by certain persons,
including food transporters, that would be available to FDA to identify
the immediate previous sources, and immediate subsequent recipients, of
food, in order for FDA to address contamination that presents serious
adverse health consequences or death to humans or animals.
    (Comment 150) A comment states that if a bulk trailer is offered
for loading with a wash ticket, there is little reason to provide
information about what was previously hauled therein. This commenter
asserts that in many cases a

tractor operator will obtain a trailer with a wash ticket and not know
the last food hauled in the trainer.
    (Response 150) As we discuss in our response to Comment 149, we
revised this rule in Sec.  1.908(e)(4) so that carriers will only have
to provide shippers with information about the previous load if the
shipper requests the information (in cases where the carrier and
shipper have a written agreement requiring the shipper to provide such
information). We would not expect that a shipper would request this
information under circumstances in which the shipper does not regard it
as necessary under the terms of its business relationship with the
carrier, for example, when the carrier by contract has agreed to only
provide vehicles that have previously hauled compatible ingredients or
to present a wash ticket to the shipper when the vehicle is offered.
    (Comment 151) Another comment notes that railroads do not maintain
information on previous cargoes. The commenter states that there is no
industry process to track and identify prior shipments in rail cars
that travel throughout the general system of rail transportation in
interchange service. Railroads would not have this information for
privately owned rail cars and they would not necessarily have the
information for their own rail cars that have been in service on other
railroads or rail cars that have been placed into pool arrangements.
Finally, the commenter asks us to revise this final rule so that a
railroad carrier would only be required to provide information to the
shipper that identifies the three previous movements when a shipper
requests this information, the railroad carrier has access to the
information through its ordinary course of business, and the
information is not otherwise available to the shipper.
    Similar comments state that it can be difficult to obtain last-load
hauled information from rail carriers unless the railcars being
utilized are owned, leased, or controlled by the shipper, or the
shipper is the one who is the consignee/consignor or payer of the
freight bill. Currently, no consistent or reliable mechanism exists
among rail carriers from which to obtain such information.
    One comment states that, given the complexity of the rail transport
network and the efficiency and safety of current industry practices,
the final rule should exclude rail carriers to avoid imposing needless
and onerous burden on railroads. The commenter states that the shipper
is uniquely positioned to understand the sanitary needs of the goods it
ships and therefore can prevent cross-contamination and inspect and
clean railcars prior to loads.
    Another comment states that section 11904 of the Interstate
Commerce Commission Termination Act (ICCTA) prohibits railroads subject
to the Surface Transportation Board (STB's) jurisdiction from
disclosing any ``information about the nature, kind, quantity,
destination, consignee, or routing of property tendered or delivered to
that rail carrier for transportation . . . that may be used to the
detriment of the shipper or consignee or may disclose improperly, to a
competitor, the business transactions of the shipper or consignee.'' 49
U.S.C. 11904(a)-(b). The commenter also notes that the statute
prohibits other shippers from soliciting or knowingly receiving such
information from a railroad. The commenter notes, for example, if
loaded railcars are delivered to one shipper in a terminal area and the
empty railcars are provided to a second shipper in the same terminal
area, disclosing the prior load would inform the second shipper as to
the nature of its competitor's previous cargo. The commenter argues
that this type of disclosure is prohibited by ICCTA.
    (Response 151) We acknowledge that the use of railcars in
interchange service as described by these comments would likely make it
difficult or impossible for the railcar's provider, e.g., a railroad
operator, to be able to provide information about the identity of a
bulk vehicle's previous cargoes to the shipper as we proposed in Sec.
1.908(d)(4). We also acknowledge the challenge that section 11904 of
the ICCTA may pose with respect to exchanging such information for rail
shipments. However, as discussed previously, we have revised this rule
at Sec.  1.908(b)(4) to require the shipper to develop written
procedures adequate to ensure that a previous cargo does not make the
food unsafe. These procedures may describe actions that the shipper may
take to provide this assurance (e.g., cleaning the vehicle, using a
dedicated vehicle), or they can include actions that the carrier in
accordance with Sec.  1.908(e), or another party covered by this
regulation may take to provide this assurance (e.g., providing
information about the last previous cargo of the vehicle, providing a
dedicated vehicle). In the case of a rail operator that does not
provide services related to the safety of bulk food cargoes to be
loaded onto rail cars that they provide to the shipper (e.g.,
identifying previous cargos) we would not expect that there would be a
written agreement between the shipper and the carrier to provide such
information. Consequently, this rule would place no burden upon such a
rail operator to provide such information.
    (Comment 152) Another comment notes that contract transportation
haulers notify renderers and feed manufacturers about prior loads,
including nonfoods and animal feed ingredients such as restricted use
proteins (i.e., relative to the concern for the agent that causes
transmissible spongiform encephalopathy). The comment asserts that
carriers should be responsible for cleaning out the truck trailer,
container, or railcar after hauling restricted use proteins or
hazardous materials before hauling other animal feed ingredients.
    (Response 152) While the procedures described by the commenter may
reflect the practices of most contract haulers handling raw materials
for rendering, as we discussed previously, we have revised this rule at
Sec.  1.908(b)(4) to require the shipper to develop written procedures
adequate to ensure that a previous cargo does not make the food unsafe.
These procedures may describe actions that the shipper may take to
provide this assurance (e.g., cleaning the vehicle, using a dedicated
vehicle), or they can include actions that the carrier in accordance
with Sec.  1.908(e), or another party covered by this regulation may
take to provide this assurance (e.g., cleaning the vehicle, providing a
dedicated vehicle). We believe that it would be unnecessarily
restrictive to place the burden for on food sanitation step, i.e.,
cleaning, on a specific category of persons covered by this rule, and
that the system described at Sec.  1.908(b)(4) and (e) is sufficiently
protective of public health.
    This rule does not address controls for specific food safety
hazards, such as the agent that causes transmissible spongiform
encephalopathy. As we stated in the proposed rule (79 FR 7006 at 7011),
we have established requirements in Sec.  589.2000 (``Animal proteins
prohibited in ruminant feed'') and Sec.  589.2001 (``Cattle materials
prohibited in animal food or feed to prevent the transmission of bovine
spongiform encephalopathy'') addressing cleanout requirements and
dedicated equipment requirements for equipment used in the distribution
of specified feed ingredients to prevent the contamination of ruminant
feed and animal food or feed, respectively.
e. Proposed Sec.  1.908(d)(5)
    We proposed to require that a carrier that offers a bulk vehicle
for food transportation must provide information to the shipper that
describes the most

recent cleaning of the bulk vehicle, except that a shipper and carrier
may agree in writing that the carrier need not provide any such
information, if the carrier follows procedures that would ensure that
the bulk vehicle offered will be adequate for the intended
transportation operation, e.g., if the carrier has contractually agreed
to use a specified cleaning procedure at specified intervals or if the
shipper cleans the vehicle at his own facility, subject to the records
requirements of Sec.  1.912(b).
    Consistent with our discussion concerning the duties of the shipper
as a result of the requirements of Sec.  1.908(b)(4), we have removed
the provisions of proposed Sec.  1.908(d)(5), concerning alternative
arrangements for the responsibility to provide previous cleaning
information to the shipper. This provision is no longer needed because
new Sec.  1.908(b)(4) and the new language at new Sec.  1.908(e)
provide the same flexibility to assign responsibility for this function
as was provided by proposed Sec.  1.908(d)(5).
    (Comment 153) Some comments support the proposed provision. One
comment states that all cleanout procedures, including wash out for
trailers, should be documented.
    (Response 153) We have retained these provisions in this final rule
with some modifications as noted in the paragraphs immediately
preceding this comment.
    (Comment 154) One comment asserts that given the strict procedures
currently in place to manage medicated feed transport, we do not need
to include a previous vehicle cleaning provision in this rule with
respect to the transportation of medicated feed.
    (Response 154) Under this rule as we have revised it, the shipper
has the prerogative to request from the carrier information describing
the bulk vehicle's most recent cleaning when a contract between the
shipper and receiver provides for such information exchange. We are
retaining this provision to allow the shipper to obtain this
information from the carrier if the shipper deems it necessary under
these circumstances for the purposes of ensuring that his product does
not become unsafe during transportation. Our regulations addressing
medicated feed cleanout procedures (21 CFR 225.65 and 225.165) do not
provide shippers with access to this type of information from carriers.
If, however, a shipper has determined that the provisions of 21 CFR
225.65 or 225.165 adequately address his circumstances, the shipper may
choose to not request this information from the carrier.
    (Comment 155) Another comment states that providing information to
the shipper describing the cleaning of a bulk rail car is beyond the
current capabilities of railroad operators. The commenter observes that
railroads do not generally clean rail cars and do not track the
cleaning of railcars. The commenter states that railroad operators do
not have access to cleaning records for rail cars that they do not own
that are cleaned by customers on site or at third-party locations. The
commenter also states that, even if a railroad owns the railcar,
railcar operators routinely enter into contractual arrangements whereby
the lessee becomes responsible for cleaning the railcar, and that based
on the lack of incidents involving food transported in bulk railcars,
there is no reason to impose these burdensome requirements on railroad
carriers. The commenter therefore asks us to revise this final rule to
require a railroad carrier to provide information to the shipper that
describes the most recent cleaning of a bulk vehicle when a shipper
requests such information, the railroad carrier has access to the
information through its ordinary course of business, and the
information is not otherwise available to the shipper.
    (Response 155) We acknowledge that the use of railcars in
interchange service as described by this these comments would likely
make it difficult or impossible for the railcar's provider, e.g., a
railroad operator, to be able to provide information about the previous
cleaning of a bulk car to the shipper as we proposed in Sec.
1.908(d)(5). However, as we discussed previously, we have revised this
rule at Sec.  1.908(b)(4) to require the shipper to develop written
procedures adequate to ensure that a previous cargo does not make the
food unsafe. These procedures may describe actions that the shipper may
take to provide this assurance (e.g., cleaning the vehicle, using a
dedicated vehicle), or they can include actions that the carrier in
accordance with Sec.  1.908(e), or another party covered by this
regulation may take to provide this assurance (e.g., cleaning the
vehicle, providing a dedicated vehicle). In the case of a rail operator
that does not provide services related to the safety of bulk food
cargos to be loaded onto rail cars that they provide to the shipper
(e.g., providing information related to the cleaning of vehicles) we
would not expect that there would be a written agreement between the
shipper and the carrier to provide such information. Consequently, this
rule would place no burden upon such a rail operator to provide such
information.
    (Comment 156) Another comment asks us to permit companies to use a
written single generic guideline for all hired carriers with procedures
addressing prior loads and the cleaning of bulk vehicles. The comment
states that if a carrier commits to a shipper to use dedicated bulk
containers or compatible raw ingredients and products, there should be
no need for further procedures unless the shipper and carrier want to
specify further details.
    (Response 156) A shipper may operate in the manner described in
this comment consistent with the requirements of this rule in Sec.
1.908(e)(4) and (5). We acknowledge that an agreement provided to all
hired carriers might state circumstances in which the shipper would
want to know the identity of the previous cargo and information about
the most recent cleaning of a bulk vehicle.

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

    We proposed to require that carriers must provide training to
personnel engaged in transportation operations that provides an
awareness of potential food safety problems that may occur during food
transportation, basic sanitary transportation practices to address
those potential problems and the responsibilities of the carrier under
this rule. The training must be provided upon hiring and as needed
thereafter. We also proposed to require that carriers must establish
and maintain records documenting the aforementioned training. Such
records must include the date of the training, the type of training,
and the person(s) trained. These records are subject to the records
requirements of Sec.  1.912(c). In table 9, we describe revisions to
proposed Sec.  1.910 and following the table we respond to comments
related to these provisions.

    Table 9--Sec.   1.910 What Training Requirements Apply to Carriers Engaged in Transportation Operations?
----------------------------------------------------------------------------------------------------------------
              Proposed section                           Description                        Revision
----------------------------------------------------------------------------------------------------------------
1.910(a)....................................  Requires carriers to provide      Requires carriers to provide
                                               awareness training to personnel   awareness training to personnel
                                               engaged in transportation         engaged in transportation
                                               operations.                       operations when the carrier and
                                                                                shipper have agreed via written
                                                                                contract that the carrier is
                                                                                responsible for the sanitary
                                                                                conditions during
                                                                                transportation operations.
1.910(b)....................................  Requires that carriers maintain   No change.
                                               records documenting the
                                               training required in (a).
----------------------------------------------------------------------------------------------------------------

    (Comment 157) Several comments state that the training requirements
should also apply to shippers and receivers who conduct loading and
unloading operations in which they contact or handle food.
    (Response 157) We do not agree and affirm our tentative conclusion
in the proposed rule (79 FR 7006 at 7027) that training needs for
shippers and receivers would be most appropriately addressed through
the training provisions in our cGMP regulations for human and animal
food because these regulations contain provisions related to sanitation
focused employee training specifically tailored for entities that would
operate as shippers, receivers and loaders under this rule.
    (Comment 158) Some comments from the railroad industry state that
railroads that do not handle food should not be subject to the training
requirements of this rule and that these requirements should instead
apply to shippers and receivers who actually contact and handle food
shipped by rail.
    (Response 158) We have addressed the portion of this comment that
relates to training for shippers and receivers in our response to
Comment 157. We agree that carriers, including railroads, that do not
perform food transportation activities that may affect the sanitary
condition of food would not benefit from training related to sanitary
food transportation. For this reason, we have modified the carrier
training requirement to require such training when the carrier and
shipper have agreed in a written contract that the carrier is
responsible, in whole or part, for the sanitary conditions during
transportation operations. This revision is designed to be consistent
with revisions at Sec.  1.908(b)(3), (4), (5), and (e), discussed in
the relevant sections of this document, that address when the carrier
is made responsible for certain sanitary conditions during food
transportation operations under this rule.
    (Comment 159) Some comments state that training should be available
to State and local regulatory officials.
    (Response 159) As we discuss in our response to Comment 19, we are
aware of the training needs for regulators and we will seek to
establish partnerships with other Federal Agencies, and States and
Tribes in implementing this rule which would include addressing these
training needs.
    (Comment 160) A comment requests more information about what type
and amount of training would be sufficient to meet the requirements of
this rule. It also states that a one-size-fits-all approach would
likely overburden carriers who have little or no contact with food in
their operations and likewise be insufficient for carriers whose
operations involve a high degree of contact with food. Some comments
mention that the content, frequency and length of training should be
within the discretion of the carrier. Some comments state that a half-
day long training seems unnecessary for this regulation. One comment
requests that we provide flexibility in the training requirements for
the transportation of chemical food additives and GRAS substances.
    (Response 160) Beyond the general requirements stated in Sec.
1.910, we are not prescribing details on aspects of the training such
as its frequency, length, and subject matter. Given the diversity of
food transportation operations, we do not intend to require that the
entire industry use a single training approach. Training may vary in
particular aspects, e.g., length, provided that it meets the
requirements of this rule. Thus, firms conducting differing types of
transportation operations may employ training that is tailored to their
operations provided that it meets the requirements of this rule. A firm
that does not transport temperature controlled foods need not train
their employees and food handlers in practices for providing
temperature control during transportation. Transporters of chemical
food additives may exercise the same selectivity in designing training
programs for their operations.
    (Comment 161) Some comments ask that we acknowledge in the final
rule that industry training on food and feed safety systems will be
acceptable and that we will not require that training be specific to
this rule.
    (Response 161) If industry training programs not specifically
designed to address the requirements of this rule, nonetheless meets
the requirements of Sec.  1.910, such training would be acceptable
under this rule. However, note that Sec.  1.910 prescribes that the
training, among other things, address the responsibilities of the
carrier under this rule.
    (Comment 162) A comment states that there will not be sufficient
time or resources to train ``qualified individuals'' during the one
year implementation period following the publication of the final rule.
Some comments request that we establish guidelines for the development
of standardized training materials. A comment requests that we develop
standardized training programs that can be downloaded from our Web
site, similar to the educational materials we have made available for
food defense training and education.
    (Response 162) The term ``qualified individual'' was not used in
the proposed rule. It is used in this final rule in connection with
determinations that food is safe when an indication of a possible
material failure of temperature control or other conditions that may
render the food unsafe occurs during transportation (Sec.
1.906(a)(6)). While the Preventive Controls rules for human and animal
feed set minimum training requirements for qualified individuals, as
that term is used in those regulations, no training or other standards
are set in this regulation with regard to qualified individuals.
    With regard to training for carriers, small businesses will have 2
years after the publication of the final rule to comply with its
requirements. All other businesses subject to this rule will have 1
year. We believe firms will be able to comply with the training
requirements of this rule within their allotted timeframes given these
size based compliance dates and given the relatively brief and readily
accessible

nature of the training we envision. We have given additional
consideration to the nature of training needed to raise awareness by
carriers of food sanitation concerns and controls and have concluded
that it can be accomplished in less than one hour. That is not to say
that some carriers may not find it valuable to provide more detailed
training to individuals, for example on specific duties, such as bulk
container cleaning. But the training that is mandated as a minimum by
Sec.  1.910(a) is intended to raise awareness rather than set out
carrier-specific duties. It is our intention to develop and place on
our Web site a course that can be downloaded or taken online that would
meet the requirements of this provision. The model for this training
effort is our on-line food defense training materials. We anticipate
working with interested third-party alliances in the development of
this material. Carriers would also be able to print a copy of a
certificate of participation in the course to satisfy the training
recordkeeping requirement of the rule (Sec.  1.910(b)). Participation
in the course posted on FDA's Web site would not be mandatory. Training
from other sources, or conducted in-house by carriers, may also meet
the requirements of 1.910(a). Our intent is to provide a low cost
(labor cost only) means of satisfying the requirement.
    (Comment 163) A comment asks whether we have considered having this
training be a requirement to obtain a truck driver's license.
    (Response 163) A Commercial Driver's Licenses (CDL) is required to
operate a tractor-trailer for commercial use. CDLs are issued by the
States and are subject to requirements of DOT's Federal Motor Carrier
Safety Administration. FDA has no authority to establish requirements
for obtaining a CDL. Further, we believe that a requirement for safe
food transportation training for all CDL holders would be unnecessarily
burdensome, since many such drivers are not involved in transporting
food.
    (Comment 164) Some comments express willingness to work with us and
other carrier and shipper organizations to develop sanitary food
transportation training. Several comments state that the Seafood HACCP
Alliance could best serve this purpose since it already has an
established history in providing training, and has sufficient
stakeholder involvement and the infrastructure in place to design,
develop, and deliver training.
    (Response 164) We commend the willingness of organizations to
partner in developing sanitary food transportation training. Training
alliances such as the Seafood HACCP Alliance have effectively
functioned for this purpose in the past. We believe that a similarly
constituted alliance would be useful for developing and promoting
training for sanitary food transportation.

G. What record retention and other records requirements apply to
shippers, receivers, loaders, and carriers engaged in transportation
operations? (Sec.  1.912)

    We proposed that shippers and carriers: (1) Must retain all records
required under this rule for a period of 12 months beyond a specified
date when these records are used in their operations; (2) must retain
all training records for a period of 12 months beyond when the person
identified in the records continues to perform the duties for which the
training was provided; (3) must make these records available to a duly
authorized individual promptly upon oral or written request; (4) must
keep required records as original records, true copies or as electronic
records, which must be kept in accordance with part 11 (21 CFR part
11); and (5) may store specified records offsite after 6 months
following the creation of the record, if the records can be retrieved
and provided onsite within 24 hours of requests for official review. We
also specified that all records required by this rule are subject to
the disclosure requirements of part 20 (21 CFR part 20). In table 10,
we describe revisions to proposed Sec.  1.912 and following the table
we respond to comments related to these provisions.

    Table 10--Sec.   1.912 What Record Retention and Other Records Requirements Apply to Shippers, Receivers,
                           Loaders, and Carriers Engaged in Transportation Operations?
----------------------------------------------------------------------------------------------------------------
              Proposed section                           Description                        Revision
----------------------------------------------------------------------------------------------------------------
1.912.......................................  Records requirements for          Add ``receiver'' and ``loader''
                                               shippers and carriers.            to be subject to certain
                                                                                records requirements.
1.912(a)....................................  Records that shippers must        Split requirement into 2 parts:
                                               retain to demonstrate that they  (1) Requires shippers to retain
                                               provide information to carriers   records that demonstrate that
                                               as a regular part of their        they provide specifications and
                                               operations for 12 months beyond   operating temperatures to
                                               when the shipper may need to      carriers for 12 months beyond
                                               provide such information.         termination of the agreement
                                                                                with the carriers
                                                                                (2) Requires shippers to retain
                                                                                records of written agreements
                                                                                and procedures required by
                                                                                1.908(b)(3), (4), and (5) for a
                                                                                period of 12 months beyond when
                                                                                the agreements and procedures
                                                                                are in use.
1.912(b)....................................  Carriers must retain certain      Removed reference to retention
                                               written agreements and records    of written agreements required
                                               of written procedures for 12      by 1.908(d)(2)(ii) and
                                               months beyond when the            redesignated 1.908(d) to (c).
                                               agreements and procedures are
                                               in use.
1.912(c)....................................  Carriers must retain training     Revised ``continues to perform''
                                               records for 12 months beyond      to ``stops performing''.
                                               when the person identified in
                                               records continues to perform
                                               the duties for which they were
                                               trained.
1.912(d)....................................  Requires persons subject to the   New provision in the final rule.
                                               rule to retain written
                                               agreements assigning tasks
                                               covered by the rule for 12
                                               months beyond the termination
                                               of the agreement.
1.912(e)....................................  Requires covered parties which    New provision in the final rule.
                                               operate under ownership or
                                               control of a single legal
                                               entity must retain records of
                                               their written procedures for 12
                                               months beyond when the
                                               procedures are in use.
1.912(f)....................................  Requires that cover parties make  Adds ``loaders'' and
                                               all records available to duly     ``receivers'' to this provision
                                               authorized individuals upon      Provision was proposed as
                                               request.                          1.912(d).

1.912(g)....................................  Records must be kept as original  Remove the requirement that
                                               records, true copies, or          electronic records must be kept
                                               electronic records.               in accordance with part 11 of
                                                                                this chapter.
                                                                                Provision was proposed as
                                                                                1.912(e).
1.912(h)....................................  Clarifies that electronic         New provision resulting from the
                                               records are exempt from the       change to 1.912(g).
                                               requirements of part 11.
1.912(i)....................................  Allows for offsite storage of     Remove ``after 6 months
                                               records after 6 months and        following the date that the
                                               clarifies that electronic         record was made'' limitation
                                               records are onsite if they are    for offsite storage of records.
                                               accessible from an onsite        Provision was proposed as
                                               location.                         1.912(f).
1.912(j)....................................  All records subject to            No change. Provision was
                                               disclosure requirements of part   proposed as 1.912(g).
                                               20.
----------------------------------------------------------------------------------------------------------------

    (Comment 165) Several comments assert that we should exempt
sanitary food transportation electronic records from compliance with
part 11 and instead should take a more practical and simpler approach
to requiring the authentication of electronic records. Some of these
comments assert that requiring compliance with part 11 would be overly
burdensome and cost-prohibitive and that this requirement is
unnecessary because it would not significantly benefit the public
health and is disproportionate to the regulatory need. Other comments
assert that few, if any, entities engaged in the transportation of food
would be able to meet this requirement because of the complexities
involved with complying with part 11.
    Some comments state complying with part 11 would mean that current
electronic records and recordkeeping systems would have to be
redesigned and would require the use of specialized and expensive
software, which many small shippers, carriers and receivers might not
be able to afford. Another comment states that compliance with the
electronic records requirements in part 11 would be onerous for
operations that currently use a combination of paper and electronic
recordkeeping systems and that the effective integration of electronic
recordkeeping systems throughout the food transportation chain might
not be achievable given the diverse nature of the parties involved in
the food transportation system and the different types of electronic
systems that are currently used by the industry.
    One comment acknowledges the importance of requiring that firms
have adequate safeguards in place to ensure that electronic records
cannot be altered, but asks us to provide the transportation industry
with the flexibility to allow it to continue using, or to begin using,
any existing electronic recordkeeping system that accomplishes this
goal without mandating complete compliance with the prescriptive
requirements in part 11. According to these comments, allowing the
transportation industry to use existing electronic recordkeeping
systems would enable industry to achieve our stated electronic
recordkeeping goals efficiently and cost-effectively. A related comment
urges us to provide a clear statement that companies may use any
electronic recordkeeping systems as long as they ensure that all
records are valid, accurate, and cannot be surreptitiously altered even
if those electronic recordkeeping systems do not meet the prescriptive
requirements of part 11.
    (Response 165) We agree that redesigning large numbers of existing
electronic records and recordkeeping systems would create a substantial
burden disproportionate to the public health need. Therefore, we are
providing in new Sec.  1.912(g) of this final rule that records that
are established or maintained to satisfy the requirements of this rule,
and that meet the definition of electronic records in Sec.  11.3(b)(6)
are exempt from the requirements of part 11. We also are specifying
that records that satisfy the requirements of this rule, but that also
are required under other applicable statutory provisions or
regulations, remain subject to part 11. The rule provides that parties
covered by this rule may rely on existing records to satisfy the
requirements of this rule, and this rule does not change the status
under part 11 of any such records if those records are currently
subject to part 11. We are also establishing a conforming change in
part 11, as new Sec.  11.1(n), which says that part 11 does not apply
to records required to be established or maintained by this rule, and
that records that satisfy the requirements of this rule, but that also
are required under other applicable statutory provisions or
regulations, remain subject to part 11.
    Although we are not specifying that part 11 applies, we expect
parties covered by this rule to take appropriate measures to ensure
that records are trustworthy, reliable, and generally equivalent to
paper records and handwritten signatures executed on paper.
    (Comment 166) Some comments assert that the 12 month record
retention requirement in proposed Sec.  1.912(a) is unnecessary and
burdensome. One comment states that the time and costs required to
create and maintain records for this rule will far outweigh the
benefits of collecting and storing the information. One comment states
that requiring record retention for 12 months beyond the last date of
the activity described by the record as set forth in proposed Sec.
1.912(a) is confusing. The comment interprets the language of proposed
Sec.  1.912(a) as requiring perpetual record retention activity for
persons covered by this rule by continually adding an additional 12
month record retention period beyond the latest requirement. The
comment also states that the proposed requirement that carriers retain
training records for a period of 12 months beyond when the person
identified in such records continues to perform the duties for which
the training was provided is confusing, and asks us to restate the
requirement more clearly. The comment asks, for example, if a person
receives a refresher training course 11 months after the initial
training, and then receives another refresher training course 13 months
later, all the while continuing to perform the duties for which the
training was provided, how long must the original and refresher
training records be retained?
    (Response 166) We are requiring that records be retained for a
period 12 months beyond the last date of the activity described by the
record, so that we can review the past practices of a shipper or
carrier that may not currently be engaged in food transportation
operations. Maintaining such records on

an ongoing basis will not be burdensome because the practices described
in such records, e.g., vehicle cleaning practices, procedures for
providing information to shippers and carriers, etc., are likely to be
ongoing operating practices that change very little over time. We
therefore do not believe that further clarification of Sec.  1.912(a)
is necessary. With respect to refresher training, we would only expect
records of the refresher training to be retained for our examination if
such training was necessary for the person to continue to meet the
training requirement of Sec.  1.910(a). For example, if a carrier
previously only transported food that does not require temperature
control for safety, e.g., was refrigerated strictly for quality
purposes, and thus, not subject to this rule, but was beginning to
transport shell eggs, it would be necessary to ensure that a vehicle
operator was aware of the potential food safety problems and associated
temperature control needs for shell egg transportation.
    (Comment 167) A few comments commend our ``practical approach'' of
not proposing that carriers or shippers would have to maintain a
``roomful of records'' documenting conditions for individual shipments.
These comments state that while our generally practical approach has
been conveyed to the food transportation industry repeatedly at FDA's
public meetings, it was not discussed in detail in the preamble to the
proposed rule. These comments encourage us to explain our regulatory
philosophy in the preamble to this final rule in order to prevent
deviations from our public statements in the future and to reinforce
our intent. These comments also state that our field inspectors should
be trained to understand that this regulation's recordkeeping
requirements differ from the requirements under other FSMA regulations
and that FDA inspectors should be trained not to ask for transportation
records beyond those that are legally required under this final rule. A
similar comment states that this rule is silent with respect to the
retention of shipment records related to truck inspections, pre-cooling
activities, and temperature monitoring, and asks us to make clear that
the retention of such records is outside the scope of the rule.
    (Response 167) Some of these comments refer to statements that we
made in public meetings (Refs. 29 and, 30) in Chicago, IL and College
Park, MD regarding the proposed rule.
    In the Chicago meeting, for example, we stated: ``[A] carrier will
have to provide information to shippers if it's a bulk carrier, about
prior cargoes in its vehicle. We're not looking for a record of every
prior cargo that was transported in every bulk vehicle the carrier
operates. What we want to see is an SOP, that's the carrier's record .
. . that states how it provides this information to the shipper.'' We
further stated during the Chicago meeting that: [W]e're not looking for
operational records that are going to fill a room up to the ceiling--
[for example,] time, temperature, strip chart recordings--for every
transportation operation for refrigerated food or cleaning records for
every bulk tanker, we're looking for a procedure from the carrier that
describes how he will provide this information to the shipper.''
Finally, we also said during the Chicago public meeting that: ``[W]e've
done all that we can to minimize the burden of this recordkeeping
requirement, but enable us to verify that this information exchange,
which we think is an important part of sanitary transportation
practices, is taking place.'' We stated during the College Park public
meeting that: ``[W]e are not looking for carriers to fill up some room
with time-temperature strip chart recordings for every load of
refrigerated food that they transport and show those records for every
operation that they conduct to the FDA. We are looking for the carrier
to, in the form of a record, provide FDA [with] records that
demonstrate that they do conduct this information exchange with
shippers, that they do provide, as a part of their operation,