(Comment 40) We received a comment asking us to clarify what
actions food transporters must take to assure compliance when their
food product is intended exclusively for export markets. Another
comment states that many commodities intended for export are shipped in
standard ocean containers (known in the industry as forty-foot
equivalent units (FEUs) and twenty-foot equivalent units (TEUs)), which
are owned or leased by steamship lines. This means that the shipper,
carrier, and receiver, as identified in the proposed rule, do not own
the ocean-going container, which often travels on a truck or rail
chassis before reaching a U.S. port for export. The comment asserts
that this complicates the relationships and documentation required in
the proposed rule between the shipper and the container holder for
exports.
    (Response 40) The 2005 SFTA states that we must, by regulation,
require shippers, carriers by motor vehicle or rail vehicle, receivers,
and other persons engaged in the transportation of food to use sanitary
transportation practices prescribed by the Secretary to ensure that
food is not transported under conditions that may render the food
adulterated. Further, the statute defines ``transportation'' as any
movement in commerce by motor vehicle or rail vehicle. Thus, persons
engaged in the transportation of food that is intended for export are
subject to all applicable requirements of this rule when the food is in
transit by motor vehicle or rail vehicle to the land-based U.S. border
point of export or a port facility. For example, the loader for a truck
transportation segment moving the food to a vessel port facility is
subject to the rule because it is loading a motor vehicle. The loader
for the trans-oceanic ship transport segment is not subject to the rule
because the rule does not cover transportation operations for water
borne transportation. However, the operations of the second loader are
still subject to section 402(a)(4) of the FD&C Act, which prohibits the
holding of food under insanitary conditions whereby it may be rendered
injurious to health or may become contaminated with filth.
    We recognize that under typical practices in the industry, ocean
containers are likely to be inspected and otherwise prepared for
transportation by the person who loads the container, e.g., the shipper
or loader, not by the owner or supplier of the container. As we discuss
in our response to Comment 53, this rule does not place any
requirements upon the owner or supplier of the container whether
foreign or domestic, in circumstances where they are not a shipper,
loader, or carrier, and thus we do not anticipate that there will be
relational or documentation issues for shippers to address with such
equipment owners as a result of this rule.
    (Comment 41) Another comment asks us to include an exemption for
human and animal food originating in the United States but bound for
export from the requirements of this rule. The comment notes that the
proposed rule would not apply to transportation operations for food
that is imported but is not ``consumed or distributed'' in the United
States because it is exclusively destined for subsequent export. The
comment states that food that originates in the United States and is
bound for export travels by vehicle or rail car to reach U.S. ports of
exit and, like food that is transshipped through the United States to
another country or food that is imported for export, it is neither
consumed nor distributed until it reaches foreign soil. The comment
therefore recommends that we exempt food that originates in the United
States, but that is bound for export, from this rule by including under
Sec.  1.900(b) the provision: ``Human and animal food that moves under
Customs and Border Protection (CBP) export reporting procedures
including Automated Export System (AES) and is therefore neither
consumed nor distributed in the United States.'' The comment asserts
that requiring that the shipments of the food comply with CBP export
reporting and documentation procedures ensures that cargo bound for
export will not be diverted into the U.S. food supply for domestic
consumption.
    (Response 41) We decline to exempt persons engaged in the
transportation of human and animal food originating in the United
States and bound for export from the requirements of this rule, because
food that originates in the United States and is bound for export is
handled in a fundamentally different manner than food that is
transshipped through the United States to another country, for example
from Mexico for delivery to Canada, or food that is imported for future
export in accordance with section 801(d)(3) of the FD&C Act, and that
is neither consumed nor distributed in the United States. In the cases
of import for export and transshipment, legally enforceable mechanisms
exist that ensure that the food will not be diverted for consumption or
distribution in the United States.
    With respect to food that is transshipped through the United States
to another country, CBP regulations in 19 CFR 18.10, ``Kinds of
Entry,'' list the various entries and withdrawals that may be made for
merchandise transported in bond. One kind of entry is the
transportation and exportation (T&E) entry. A party that transships
merchandise in bond through the United States must submit T&E
documentation with the CBP and the CBP supervises the shipment of the
merchandise through the United States, as well as the intact export of
the goods to foreign destinations.
    Similarly, under section 801(d)(3) of the FD&C Act, parties which
import certain articles that are intended exclusively for further
processing or incorporation into another product and for subsequent,
mandatory export because the articles cannot be distributed or used in
the United States must provide FDA with certain information at the time
of initial importation. These articles include food subject to this
rule, specifically, food additives, color additives and dietary
supplements. These parties must provide, among other things, a
statement that confirms their intent to further process such articles
or incorporate such articles into a product for purposes of subsequent
export, and must provide us with the identities of the entities in the
chain of possession of the imported articles while the articles are in
the United States. Importers also must provide us with certificates of
analysis, as necessary, to identify the article of food. In addition,
at the time of initial importation and before delivery to the importer,
initial owner, or consignee, a bond must be executed providing for
liquidated damages in the event of default, in accordance with CBP
requirements. The initial owner or consignee of the article also must
maintain records of the use and/or destruction of such imports and must
submit the records or a report to FDA upon request. The initial owner
or consignee also must destroy any article or portion thereof that is
not used in an exported product.
    The AES system, on the other hand, collects Electronic Export
Information (EEI), formerly known as Shipper's Export Declaration (or
any successor document) from persons exporting

goods from the United States, Puerto Rico, or the U.S. Virgin Islands;
between Puerto Rico and the United States; and to the U.S. Virgin
Islands from the United States or Puerto Rico. AES is the central point
through which export shipment data required by multiple Federal
Agencies is filed electronically with CBP and is operational at all
ports and for all methods of transportation. It was designed to assure
compliance with and enforcement of various export laws, improve trade
statistics, reduce duplicate reporting to multiple agencies, and
improve customer service.
    However, AES is not specifically designed to function as a legally
enforceable mechanism to ensure that food bound for export is not
diverted into the domestic supply chain and consumed in the United
States. The AES system does not become operative until food arrives at
a point of export. Therefore, if a shipper states that any given food
shipment that originates in the United States is destined for export
and transports the food without complying with the requirements of this
rule, but subsequently decides to divert the food for purposes of
domestic consumption or distribution, neither we nor the CBP would have
any way of knowing that the food had been diverted for domestic
consumption, perhaps after being transported under insanitary
conditions. In addition, unlike food transshipped through the United
States and food imported exclusively for subsequent export, food that
originates in the United States and is intended for export, whether it
is diverted for domestic consumption or is actually exported, is not
transported under a bond. Accordingly, we do not agree that a basis
comparable to that for food transshipped through the U.S., or food
imported for export, exists for exempting persons engaged in the
transportation of human and animal food that originates in the United
States but is bound for export from the requirements of this rule as
suggested by this comment.
    (Comment 42) One comment states that, when cargo is deemed to be
adulterated, one of the primary salvage markets may be destinations
outside of the United States. The comment observes that this rule
appears not to apply to food outside of the United States and argues
that, if that is the case, we should clarify that it should not apply
to food that is shipped outside of the United States to a destination
that was not the original, intended primary market.
    (Response 42) If the product has already been offered for sale in
the United States and is found to be adulterated, it cannot be legally
exported for sale in markets outside the United States. (See United
States v. Kanasco, Ltd., 123 F.3d 209 (4th Cir. 1997) (although this
case involved drug products and not food, it stands for the principle
that, if product is adulterated, it cannot be legally offered for sale
outside the United States).) The owner of the product can pursue other
lawful options, such as reconditioning the product or diverting the
product to nonfood uses. If, however, the food has not been offered for
sale in the United States and otherwise meets the requirements of
section 801(e)(1) of the FD&C Act, it can be shipped abroad and would
not be subject to the adulterated food provisions of the FD&C Act and
therefore would not be subject to this rule.
    (Comment 43) A comment requests that we address the safe disposal
of contaminated foods from a rejected delivery and the sanitization of
trailers carrying such cargo. The comment states that when a delivery
is rejected, the responsibility for and costs associated with safely
disposing of the shipment is often placed on truckers, in some cases
with little or no instructions from the shipper. Consequently,
according to the comment, drivers who need to dispose of contaminated
cargo sometimes simply dump it, give it away to the public, or sell it.
The comment states that FDA should explore, in this or a separate
rulemaking, the development of rules governing such rejections. The
comment further suggests that we should address when rule violations
can serve as the basis for the rejection of a delivery and/or a cargo
insurance claim, acceptable methods of disposing of contaminated food
products after rejection, and the apportionment of disposal costs among
parties involved in the transportation of rejected cargoes.
    (Response 43) This rule addresses the sanitary transportation of
human and animal food to prevent practices that may create food safety
risks. We recognize the burdens and uncertainties that may arise when a
load is rejected. However, the basis on which a load may be rejected,
and the disposition of and costs associated with the disposal of
rejected loads of food, are beyond the scope of this rule. We do not
agree that we should explore the development of rules to govern
rejections and/or cargo insurance claims, or rejected product disposal
issues, because they often involve purely economic considerations about
food shipments, which do not fall within our jurisdiction. Also, issues
of liability are similarly subject to Federal laws that we do not have
the authority to administer. We note, however, that if a food shipment
is rejected because it is adulterated, the person responsible for that
food cannot distribute or offer it for sale. Further, the carrier of a
rejected food shipment must ensure that the motor or rail vehicle used
to transport the rejected load complies with the vehicle and equipment
provisions of Sec.  1.906 before it is used again to transport food.

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

    The only change we made in the proposed provisions in Sec.
1.902(a) and (b), which specify that the criteria and definitions in
part 1, subpart O apply in determining whether food is adulterated
within the meaning of section 402(i) of the FD&C Act and that failure
to comply with the requirements of part 1, subpart O is a prohibited
act, was to add ``loaders'' to the list of covered entities in both
paragraphs.
    (Comment 44) One comment asks us to replace the term ``in
compliance'' throughout the final rule with the term ``in
conformance.''
    (Response 44) We decline this request. We have used the phrase ``in
compliance'' in Sec.  1.902(a) of this rule consistent with the
language of section 7202(a) of the 2005 SFTA, which amends the FD&C Act
by adding section 416 to the FD&C Act to provide that a food shall be
deemed to be adulterated ``[i]f it is transported or offered for
transport by a shipper, carrier by motor vehicle or rail vehicle,
receiver, or any other person engaged in the transportation of food
under conditions that are not in compliance with regulations
promulgated under section 416.''
    (Comment 45) Several comments express concern about food being
considered adulterated under this rule simply because of the failure of
a carrier to adhere to a shipper's specified conditions during
transport, such as maintaining a specified temperature, regardless of
whether the food is actually unsafe. In particular, these comments
speak to concerns about the impact the rule, as proposed, would have on
the cargo claims process governed by the ``Carmack Amendment'' found in
49 U.S.C. 14706. Under this provision of Federal law, a shipper or
receiver seeking to recover money for cargo loss or damage from a
carrier must show that the cargo is actually lost or damaged. The mere
possibility of damage through ``potential'' exposure is not sufficient
to prove an actual loss. One comment states that this rule is
problematic because it directly links failure to

adhere to shipper-specified conditions for transportation with
adulteration of, or damage to, food products during transport.
According to this comment, the operation of this rule would mean that a
claimant would no longer be required to prove that a shipment of food
is actually damaged, but rather would only be required to prove the
shipment was not maintained in accordance with a shipper's specified
condition. One comment also states that this rule should clearly state
in Sec.  1.902 that ``Variance from the requirements of this rule does
not create a per se presumption of adulteration, and that the
provisions of the Carmack Amendment, 49 U.S.C. 14706, still apply in
determining liability of the parties regarding loss or damage to
cargo.''
    (Response 45) We decline to make the specific change requested, but
we have made other revisions to this rule that address the commenter's
concerns. We have revised the provisions of this rule, for example,
that address instances in which a carrier might not meet a shipper's
specifications for temperature control during transportation. An
inconsequential failure by a carrier to meet the shipper's temperature
control specifications will not necessarily create a per se presumption
that the affected food has become adulterated. However, as we discuss
in our response to Comment 129, under this rule, in Sec.  1.908(a)(6),
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. Failure to take such action may render the food
adulterated.
    We also have revised this rule in Sec. Sec.  1.906 and 1.908, as we
discuss in our response to Comment 89, to clearly state that the
requirements for transportation equipment and transportation operations
are intended to prevent food from becoming unsafe during
transportation. This revision, in addition to others, makes it clear
that under this rule we will apply section 402 of the FD&C Act, as it
addresses food safety, to determine whether food has become adulterated
during transport. Persons engaged in transportation operations should
not expect that we will apply a different standard or different
criteria for evaluating compliance with this rule. Therefore, we do not
anticipate that this rule will have a significant impact on the cargo
claims process.
    (Comment 46) Some comments state that there are other common
occurrences that they believe could unnecessarily result in a
presumption of adulteration under the proposed rule. These commenters
express concern that the proposed rule can be interpreted broadly
enough to create potential issues if broken seals or evidence of
tampering create a presumption of adulteration, absent any evidence of
actual threats to the public health.
    (Response 46) We have made revisions to this rule that address the
concerns of these comments. As we stated in our response to the
previous comment, when assessing transportation equipment and
transportation operations, we will apply the food safety provisions of
section 402 of the FD&C Act as the standard for determining whether
food has become adulterated during transport. Persons engaged in
transportation operations should not expect that we will apply a
different standard or different criteria for evaluating compliance with
this rule. A broken cargo seal or any evidence of food cargo tampering
would not necessarily create a per se presumption of adulteration.
However, we advise persons engaged in transportation operations that,
if such situations should arise, they should carefully evaluate the
facts and circumstances of each incident, on a case-by-case basis, to
determine whether the safety of the food cargo may have been
compromised.
    (Comment 47) Some comments asked that we clarify, in certain
particulars, the interpretation of ``conditions not in compliance'' in
section 402(i) in the FD&C Act, the statutory adulteration provision
added to the FD&C Act by the 2005 SFTA. Under that provision, a food is
adulterated if it is transported or offered for transport by a shipper,
carrier by motor vehicle or rail vehicle, receiver, or any other person
engaged in the transportation of food under conditions that are not in
compliance with regulations issued under section 416 of the FD&C Act,
i.e., this final rule. Some of these comments expressed concern that
the application of this provision would lead to food being deemed
adulterated by regulatory authorities in the absence of physical
conditions indicating a food safety risk. One comment stated that non-
compliance with the recordkeeping provisions of this final rule alone
should not be a basis for deeming food to be adulterated, assuming the
records and documentation of the firm do not indicate a systematic and
continued failure of a firm to implement sanitary transportation
practices. A comment also asked us to recognize that under this rule,
an enforcement authority will retain the discretion to consider the
specific circumstances in each situation, e.g., if there are only minor
deviations from the requirements of this rule, in determining whether
food is adulterated.
    (Response 47) Under section 402(i) of the FD&C Act, ``a food shall
be deemed adulterated if it is transported or offered for transport by
a shipper, carrier by motor vehicle or rail vehicle, receiver, or any
other person engaged in the transportation of food under conditions
that are not in compliance with regulations promulgated under section
416.'' Section 416(b) of the FD&C Act mandates that the Secretary
create regulations requiring that food carriers use sanitary
transportation practices. Section 416(c)(1)(E) of the FD&C Act states
``the regulations under section (b) shall--(1) prescribe such practices
as the Secretary determines to be appropriate relating to-- . . . (E)
recordkeeping . . .'' The way that the statute is structured implies
that lack of or incomplete records in section 416(c)(1)(E) of the FD&C
Act would lead to the food being adulterated under section 402(i) of
the FD&C Act. The establishment of records requirements under this rule
is consistent with the statutory purpose of the 2005 SFTA. It is clear
from the statute and the legislative history that Congress intended
recordkeeping to be one of the requirements for maintaining sanitary
food transportation practices (See section 416 of the FD&C Act and S.
Rep. No. 109-120, at 46 (2005) (Ref. 25)).
    Furthermore, the Senate report (S. Rep. No. 109-120, at 46 (2005))
(Ref 25) expresses Congress' intention to grant FDA authority to deem
food adulterated on recordkeeping grounds. That report states that SFTA
``would amend section 402 of the Federal Food, Drug, and Cosmetic Act .
. . to provide that food is adulterated if transported in violation of
safe transportation practices prescribed in the new section 416 of the
FD&C Act.''
    In the seafood HACCP final rule (60 FR 65096 at 65100) we noted
that in National Confectioners Association v. Califano, 569 F.2d 690
(D.C. Cir. 1978), the courts upheld FDA's authority to issue
regulations under section 402(a)(4) of the FD&C Act that included
recordkeeping requirements, when challenged on the grounds that they
would permit prosecution where processing conditions were completely
sanitary, but the records were deficient.

Such an outcome, it was argued, would be beyond the scope of section
402(a)(4) of the FD&C Act. Citing Toilet Goods Association v. Gardner,
387 U.S. 158 (1967), the court rejected this argument and held that the
primary consideration was whether the statutory scheme as a whole, not
just section 402(a)(4) of the FD&C Act, justified the Agency's
regulations. (See Nat'l Confectioners Ass'n, 569 F.2d 690 at 693.) The
court pointed out that this consideration involved an inquiry into
practicalities as well as statutory purpose, i.e., enforcement problems
encountered by FDA and the need for various forms of supervision in
order to accomplish the goals of the FD&C Act. (Id.)
    Thus, the necessary conditions for compliance with these
regulations encompass all of the requirements in this final rule,
including those that may not appear to directly affect the safety of
the food, such as training and records. The SFTA of 2005 does not
differentiate between physical conditions indicating food safety risk
and requirements, such as training and recordkeeping.
    However, we recognize the concerns expressed by these comments and
do not believe that the SFTA of 2005 changes the way we enforce our
regulations. Before initiating enforcement action, we will consider all
circumstances surrounding the deviation(s), e.g., the nature of the
deviation, from these regulations as we have in the application of
other preventive control-type regulations, such as the seafood HACCP
regulation and the Juice HACCP regulation.
    (Comment 48) One comment states that the rule does not address the
obligations of carriers if shelf stable food is compromised during
transit or while on a dock or being loaded onto a trailer. The comment
states that when a shipment is damaged in transit, or during loading or
unloading, the carrier will frequently transport the shipment of
damaged goods to a location of the shipper's choice. The commenter asks
us, if the carrier is only qualified to handle shelf stable food, can
the carrier continue to handle the shelf stable food with compromised
packaging? The comment also asks whether the carrier would be required
to hire another carrier who has chosen to comply with the record
keeping and training requirements of the proposed rule to handle the
return of such shipments.
    (Response 48) We would have no concerns about the carrier
transporting the damaged goods to a location specified by the shipper
because, under Sec.  1.908(a)(6), an evaluation must be performed
before further distribution to determine whether the food has been
rendered unsafe.

C. What definitions apply to this subpart? (Sec.  1.904)

    We proposed to establish several definitions in Sec.  1.904. In
table 6, we describe revisions to the proposed definitions and
following the table we respond to comments related to these provisions.
We did not make changes to the definitions of adequate, animal food,
bulk vehicle, cross-contact, food not completely enclosed by a
container, pest, transportation, and vehicle.

      Table 6--Sec.   1.904 What Definitions Apply to This Subpart?
------------------------------------------------------------------------
                   Definition                            Revision
------------------------------------------------------------------------
Carrier.........................................  Revised definition to
                                                   specify that carrier
                                                   means a person who
                                                   physically moves food
                                                   by rail or motor
                                                   vehicle in commerce
                                                   within the United
                                                   States.
Farm............................................  Applied farm
                                                   definition given in
                                                   Sec.   1.227 (21 CFR
                                                   1.227).
Food............................................  Removed the term
                                                   because it is already
                                                   defined in section
                                                   201 of the FD&C Act.
Full-time equivalent employee...................  A new definition.
                                                  Full-time equivalent
                                                   employee is a term
                                                   used to represent the
                                                   number of employees
                                                   of a business entity
                                                   for the purpose of
                                                   determining whether
                                                   the business is a
                                                   small business. The
                                                   number of full-time
                                                   equivalent employees
                                                   is determined by
                                                   dividing the total
                                                   number of hours of
                                                   salary or wages paid
                                                   directly to employees
                                                   of the business
                                                   entity and of all of
                                                   its affiliates and
                                                   subsidiaries by the
                                                   number of hours of
                                                   work in 1 year, 2,080
                                                   hours (i.e., 40 hours
                                                   x 52 weeks). If the
                                                   result is not a whole
                                                   number, round down to
                                                   the next lowest whole
                                                   number.
Microorganisms..................................  Removed the term
                                                   because not needed
                                                   with revised
                                                   provisions in Sec.
                                                   Sec.   1.906 and
                                                   1.908.
Loader..........................................  A new definition.
                                                  Loader means a person
                                                   that loads food onto
                                                   a motor or rail
                                                   vehicle during
                                                   transportation
                                                   operations.
Non-Covered Business............................  Specified the limit of
                                                   $500,000 as adjusted
                                                   for inflation, in
                                                   average annual
                                                   revenues, calculated
                                                   on a rolling basis,
                                                   during the 3-year
                                                   period preceding the
                                                   applicable calendar
                                                   year. For the purpose
                                                   of determining an
                                                   entity's 3-year
                                                   average revenue
                                                   threshold as adjusted
                                                   for inflation, the
                                                   baseline year for
                                                   calculating the
                                                   adjustment for
                                                   inflation is 2011.
                                                  Added ``loader'' to
                                                   list of potential non-
                                                   covered businesses.
Person..........................................  Removed the term
                                                   because it is already
                                                   defined in section
                                                   201.
Receiver........................................  Revised definition to
                                                   specify that receiver
                                                   means any person who
                                                   receives food at a
                                                   point in the United
                                                   States after
                                                   transportation,
                                                   whether or not that
                                                   person represents the
                                                   final point of
                                                   receipt for the food.
Shelf Stable Food...............................  Removed the
                                                   definition, not
                                                   needed for revised
                                                   definition of
                                                   ``transportation
                                                   operations''.
Shipper.........................................  Revised to specify
                                                   that shipper means a
                                                   person who arranges
                                                   for the
                                                   transportation of
                                                   food in the United
                                                   States by a carrier
                                                   or multiple carriers
                                                   sequentially.
                                                  Provided examples of
                                                   shipper, such as the
                                                   manufacturer or a
                                                   freight broker.
Small Business..................................  Specified the limit of
                                                   $27,500,000 annual
                                                   receipts.
                                                  Specified that
                                                   employee limit is
                                                   fewer than 500 full-
                                                   time equivalent
                                                   employees.
Time/Temperature Control for Safety (TCS) Food..  Removed the
                                                   definition, not
                                                   relevant to revised
                                                   temperature control
                                                   provisions.
Transportation..................................  Revised to specify
                                                   that transportation
                                                   means any movement of
                                                   food by motor vehicle
                                                   or rail vehicle in
                                                   commerce within the
                                                   United States.
Transportation Equipment........................  Removed ``other than
                                                   vehicles'' for
                                                   clarity.

Transportation Operation........................  Removed ``solely'' and
                                                   ``shelf stable'' to
                                                   specify that
                                                   transportation
                                                   operations do not
                                                   include activities on
                                                   a food completely
                                                   enclosed by a
                                                   container except a
                                                   food that requires
                                                   temperature control
                                                   for safety.
                                                  Added that
                                                   transportation
                                                   operations do not
                                                   include any
                                                   activities associated
                                                   with the
                                                   transportation of
                                                   ``food contact
                                                   substances as defined
                                                   in section 409(h)(6)
                                                   of the FD&C Act,''
                                                   ``human food
                                                   byproducts
                                                   transported for use
                                                   as animal food
                                                   without further
                                                   processing,'' or live
                                                   food animals ``except
                                                   molluscan
                                                   shellfish''.
                                                  Removed ``for raw
                                                   agricultural
                                                   commodities'' to
                                                   specify that
                                                   transportation
                                                   operations do not
                                                   include any
                                                   transportation
                                                   activities performed
                                                   by a farm.
------------------------------------------------------------------------

1. Adequate
    We proposed to define the term ``adequate'' to mean that which is
needed to accomplish the intended purpose in keeping with good public
health practice. We are finalizing this definition as proposed.
    (Comment 49) One comment states that the term ``adequate'' is not
suitable for a rule intended to achieve compliance with best
transportation practices focused on reducing the risks of the
adulteration of food products. The comment suggests that instead we
should use the term ``to guarantee,'' which the comment defines as
meaning ``to ensure and protect from any risk or need,'' to avoid
ambiguity that might cause confusion and result in public health
hazards.
    (Response 49) We decline this request. The term ``adequate'' is a
long-standing term that we defined in its current form when we first
established Current Good Manufacturing Practices (cGMP) requirements
for manufacturing, packing and holding food in 1969 (see 34 FR 6977 at
6978, `` `Adequate' means that which is needed to accomplish the
intended purpose in keeping with good public health practice.''). The
requirements established in this rule address broadly applicable
procedures and practices and our use of the term ``adequate'' is
intended to provide flexibility for shippers, loaders, carriers, and
receivers to comply with the requirements in a way that is most
suitable for their practices. We are not aware that the term has caused
confusion in its use with the cGMPs and the comment does not provide
any examples of how our use of the term ``adequate'' may create
confusion that might result in public health hazards.
2. Animal Food
    We proposed to define the term ``animal food'' to mean food for
animals other than man, including pet food, animal feed, and associated
raw materials and ingredients. We are finalizing this definition as
proposed.
    (Comment 50) A few comments state that raw materials should not be
included in this definition because processing these materials into
feed ingredients and finished animal food products after they have been
transported to processing facilities removes many, if not all, of the
hazards that may be associated with the transportation of the raw
materials. One of the comments also notes that the Association of
American Feed Control Officials (AAFCO) Model Regulations exempt raw
materials (such as meat scraps) from regulation because they are not
suitable for use in animal feed without further processing.
    (Response 50) We decline to change the definition of animal food.
While the transportation of raw materials for animal feed manufacture
may not require the same degree of sanitary control as the transport of
finished animal feed, there may be circumstances in which processing
the raw materials may not remove all health hazards, e.g., fertilizer
residue from a prior cargo hauled in a vehicle, that might be caused by
the insanitary transportation of the raw materials. We have added
provisions to Sec.  1.908(a)(3) of this final rule to provide
sufficient flexibility to allow persons engaged in the transport of raw
materials, feed ingredients, or finished animal food to use sanitary
transportation practices that are appropriate for their circumstances.
3. Bulk Vehicle
    We proposed to define the term ``bulk vehicle'' to mean a tank
truck, hopper truck, rail tank car, hopper car, cargo tank, portable
tank, freight container, hopper bin, or any other vehicle in which food
is shipped in bulk, with the food coming into direct contact with the
interior surfaces of the vehicle. We are finalizing this definition as
proposed.
    (Comment 51) One comment asks us to add terms such as ``gondola''
to the examples included in this definition in the interests of
clarity.
    (Response 51) We decline to change the definition based on this
request. We are using the definition of ``bulk vehicle'' in this rule
exactly as it appears in the 2005 SFTA and as incorporated into section
416 of the FD&C Act. However, we note that the list of examples
included in the definition is not intended to be comprehensive or all
inclusive with respect to the types of vehicles that are bulk vehicles.
We define the term to include ``any other vehicles in which food is
shipped in bulk, with the food coming into direct contact with the
vehicle.''
    (Comment 52) Some comments state that in several respects, our
definition of bulk vehicle is overly broad in scope. According to one
commenter, the term ``hopper bin,'' for example, can be inferred to
mean a grain hopper bottom storage bin that is part of a storage
facility, and not a piece of transportation equipment. The comment
requests that we delete the term ``hopper bin'' from this definition.
Another comment asks us to explicitly exclude vehicles used to
transport fruit and vegetable RACs from the definition because many
RACs are thermally processed with a kill step or are cooked by the
consumer before being consumed.
    (Response 52) We decline these requests. A hopper bin constructed
as part of a facility and used for storage would not be considered
transportation equipment and therefore would not be subject to this
rule. A hopper bin on a truck or other conveyance subject to this rule,
however, is a piece of transportation equipment and therefore is
subject to this rule. We also note that while some RACs that are
transported in a bulk vehicle may undergo a kill step process or
cooking before being consumed, there may be circumstances in which
controls, e.g., the cleaning of a vehicle that was last used to haul a
nonfood item, are necessary to ensure the sanitary transportation of
certain types of RACs. We have added provisions to Sec.  1.908(a)(3) of
this rule to provide sufficient flexibility to allow persons engaged in
the transport of food intended for further processing to employ
sanitary transportation practices that are appropriate for their
circumstances.

4. Carrier
    We proposed to define the term ``carrier'' to mean a person who
owns, leases, or is otherwise ultimately responsible for the use of a
motor vehicle or rail vehicle to transport food. The definition also
specified that the carrier is responsible for all functions assigned to
a carrier in this subpart even if they are performed by other persons,
such as a driver that is employed or contracted by a trucking firm, and
that a carrier may also be a receiver or a shipper if the person also
performs the functions of those respective persons as defined in this
subpart. In the final rule, as explained in the discussion of Sec.
1.908(a)(1), we have added a general provision to that section about
the multiple roles that can be played by a single entity to replace the
separate provisions we had included in the proposed definitions of
``carrier,'' ``shipper'' and ``receiver''. We are finalizing the
definition for ``carrier'' to mean a person who physically moves food
in commerce and clarifying that a carrier does not include any person
who transports food while operating as a parcel delivery service. We
explain these changes in the responses to the next 3 comments.
    (Comment 53) Some comments oppose defining the term ``carrier'' to
mean a person who owns, leases, or is otherwise ultimately responsible
for the use of a motor vehicle or rail vehicle to transport food. These
commenters express concern that this definition would result in the
inappropriate and unworkable application of this rule's requirements to
railroad operators for the following reasons.
     Railroad operators in many cases do not own or lease the
railcars they transport, are not responsible for their storage when
they are stored in private facilities, and exercise no control over the
cars other than to inspect them for mechanical soundness during the
transportation process.
     The shipper or loader is generally responsible for
inspecting a railcar to ensure that it is suitable for the particular
food cargo, regardless of who owns the car.
     Railroad operators do not have the ability to ensure that
the shipper's sanitary and temperature control requirements are met
before or during transportation when, as is common in freight railroad
transport, other parties, e.g., the shipper, assume the responsibility
for preparing the railcars for loading, maintain their operating
conditions during transportation, and deliver the loaded car to the
railroad operator for transport.
     Railroad operators generally do not clean the cars they
provide and do not maintain documented cleaning procedures.
     The use of railcars in interchange service, in which
railroads convey freight cars from other companies over their lines
would likely mean that the railroad operator would not be able to
provide information about the identity of a bulk vehicle's previous
cargoes and its most recent cleaning if requested by the shipper.
    The commenters note that for the stated reasons, railroad operators
cannot meet requirements of this rule assigned to carriers under
proposed Sec. Sec.  1.906 and 1.908.
    These comments also contrast rail carrier and motor carrier food
transportation operations, noting that motor carriers generally own the
vehicles they provide for transport and are directly involved in
transportation operations, such as the loading and unloading of the
trailers that they haul, and therefore can comply with requirements
assigned to the carrier in Sec. Sec.  1.906 and 1.908 of the proposed
rule.
    Finally, one comment asks us to establish separate definitions for
motor and rail carriers which would assign appropriate responsibilities
for each of the two distinct types of carriers. Another comment asks us
to establish a definition specific to railroad carriers in this final
rule, which would simply define a ``railroad carrier'' as a person
providing railroad transportation services.
    (Response 53) We carefully considered these comments and we agree
that our proposed definition of the term ``carrier,'' when combined
with the structure of the proposed requirements at Sec.  1.908, which
detail the required interrelationships between carriers, shippers and
receivers, would establish requirements that some persons subject to
the definition, e.g., some railroad operators, typically cannot meet,
and which are currently performed by other parties, e.g., the shipper.
Because it is our intent to pattern this rule on existing industry best
practices, we agree that we should not reassign responsibilities for
activities that affect food sanitation during transportation in this
final rule in a manner that is so fundamentally divergent from current
practice.
    We recognize that, in practice, the person who assumes
responsibility for functions assigned to a carrier under Sec.  1.908 of
the proposed rule is identified by mutual agreement between the shipper
and that person, e.g., the trucking firm, the railroad operator, the
railcar management firm, or that the shipper may itself assume the
responsibility. We also recognize, as one of the comments mentions,
that railroad operators typically do not assume these responsibilities.
Nonetheless, we are aware that, though not common in the rail
transportation of food, some railroad operators do perform functions
that affect the sanitary condition of a railcar during transportation
of the food, e.g., monitor the temperature of the car. However, we do
not agree that a separate definition for rail carriers is the
appropriate solution, because some rail carriers, in fact, perform
functions that are typically performed by motor carriers. Rather, we
have concluded that the appropriate solution with regard to the
definition and the overall carrier regulatory requirements is: (1) A
simplified definition of carrier that ties it to the movement of the
food; (2) removal from the carrier definition of any assignment of
duties; and (3) a default assignment of responsibility to the shipper
for the activities assigned to carriers in the proposed rule, unless a
written contract between the shipper and carrier assigns them to the
carrier (or another party covered by this regulation, as may be the
case). We are aware that contracts for services that impact food safety
(e.g., monitoring temperatures, cleaning vehicles) generally are in
place when rail or motor carriers provide such services. Therefore,
linking responsibility for the carrier to perform such functions to the
existence of a contract with the shipper, in which such functions are
specified, seems appropriate and consistent with current industry best
practice.
    For these reasons, we have revised the definition of carrier to
mean a person who physically moves food by rail or motor vehicle in
commerce in the United States. We have removed from the definition the
proposed sentence that assigned duties to the carrier, because of the
consequences of such assignment, especially relative to rail carriers,
as discussed in this document, and because, upon further consideration,
we view such language to be inappropriate for a definition. We have
also removed from the definition the proposed sentence that stated that
a carrier may also be a receiver or a shipper if the person also
performs the functions of those respective persons. While we affirm
that this statement is valid, we have consolidated this and similar
statements in the proposed definitions of shippers and receivers in the
regulatory text at Sec.  1.908(a)(1).
    (Comment 54) A few comments urge us to consider that home grocery
delivery services may originate from locations other than food

establishments, such as a distribution center. According to the
comments, the transportation of the food from distribution center to
the consumer would be subject to the proposed requirements for a
carrier. The commenters note, however, that there would be no receiver
in this scenario because the definition of receiver explicitly excludes
consumers. The comments ask us to revise the final rule so that it does
not impose unnecessary regulatory burdens for home grocery deliveries
originating at locations other than food establishments.
    (Response 54) Home grocery delivery operations at food distribution
centers are generally permitted by States as retail establishments and,
therefore, would be included in a waiver of certain transportation
operations performed by such retail food establishments. We stated in
the proposed rule (79 FR 7006 at 7029-7030) that we had tentatively
determined that it would be appropriate to waive the applicable
requirements of this rule, if finalized as proposed, with respect to
retail food establishments holding valid permits, only when engaged in
transportation operations as receivers, or as shippers and carriers in
operations in which food is relinquished to consumers after
transportation from the establishment. As we stated in section III.E.,
we intend to publish a waiver in the Federal Register addressing this
class of persons prior to the compliance date of this final rule.
    (Comment 55) A participant in one of the public meetings we held on
the proposed rule asked whether this rule applies to food shipped by
the U.S. Postal Service or by private small parcel carriers. One
submitted comment states that the impact of the rule would be
significant and costly if it is applied to small-parcel common
carriers, and therefore asks us to affirmatively state that small-
parcel common carriers will be excluded from the definition of
``carrier.'' The comment notes that small-parcel common carriers handle
millions of packages per day containing a broad range of goods,
including clothing, shoes, food products, electronics products, and
books. The comment asserts that requiring these carriers to understand
the unique shipping requirements for every product that they transport
would be unduly burdensome and nearly impossible to accomplish. The
comment further argues that if FDA requires that small-parcel common
carriers meet the requirements imposed on dedicated food carriers, some
common parcel carriers, especially large-scale common carriers, will
respond by simply excluding all food shipments from their operations.
According to the commenter, this result would likely reduce the
availability of some of the most cost-effective transportation channels
for certain food shippers, even where there have been no demonstrated
food safety risks associated with their food product delivery
operations. Finally, the commenter suggests that the more appropriate
way to ensure food safety under these circumstances would be to require
the shipper of any small parcel to ensure that the selected method of
transportation is appropriate for the food product at issue.
    (Response 55) We agree that it is not appropriate to subject the
operations of the U. S. Postal Service or private delivery services
delivering parcels to consumers to this rule, given that these carriers
transport a broad range of items and do not offer transportation
services tailored to the transportation of food products. We,
therefore, have added a provision to the definition of the term
``carrier'' in Sec.  1.904 of this final rule stating that the term
does not include any person who transports food while operating as a
parcel delivery service. Our expectation is that the person shipping
the package would ensure that the selected method and circumstances of
transportation are appropriate for the food product at issue, including
food that is delivered by small-parcel common carriers.
5. Cross-Contact
    We proposed to define the term ``cross-contact'' to mean the
unintentional incorporation of a food allergen as defined in section
201(qq) of the FD&C Act into food, except animal food. We did not
receive any comments on this definition and are finalizing it as
proposed.
6. Farm
    We proposed to define the term ``farm'' to mean a facility in one
general physical location devoted to the growing and harvesting of
crops, the raising of animals (including seafood), or both. The
proposed definition of ``farm'' included facilities that pack or hold
food, regardless of whether all food used in such activities is grown,
raised, or consumed on that farm or another farm under the same
ownership. We are revising the definition of ``farm'' in this rule to
be consistent with the definition of ``farm'' used in other FSMA
rulemakings. We discuss our considerations of the comments we received
on the definition of ``farm'' in the response to Comment 55 and,
additionally, in our response to Comment 8.
    (Comment 56) Several comments that address provisions of the
proposed definition of ``farm'' suggest that the definition include
terms such as a ``facility,'' or an ``establishment,'' or a ``place.''
Other comments suggest that the definition should include consideration
of the locations and the numbers of the structures that constitute a
farm.
    (Response 56) As we explained in our response to Comment 8, we have
revised the definition of the term ``farm'' in this final rule to align
it with the revised definition of the term in 21 CFR 1.227, which was
recently established in the FSMA preventive control for human food
final rule (80 FR 55908 at 55925). The comments that we received for
this rulemaking address provisions of the farm definition that have
already been addressed in the rulemaking for preventive controls for
human food. Therefore, there is no need for us to address these issues
further in this rulemaking.
7. Food
    We included the definition of the term ``food'' in the proposed
rule just as the term is defined in section 201(f) (21 U.S.C. 321(f))
of the FD&C Act. We have deleted this definition from this final rule,
however, because Sec.  1.904 of the rule clearly states that ``[t]he
definitions and interpretations of terms in section 201 of the [FD&C
Act] are applicable to such terms when used'' in this rule. Food
includes animal food and food also food subject to the FMIA, the PPIA,
and the EPIA.
    (Comment 57) One comment asks us to explicitly exclude food contact
shipping and storage equipment from the rule's definition of ``food.''
The comment also asks us to clarify that empty food contact shipping
and storage equipment will be regulated exclusively as ``transportation
equipment'' under this rule. Finally, the comment asks us to clarify
that equipment suppliers, including food contact equipment suppliers,
are not shippers, carriers or receivers of ``food.''
    (Response 57) The definition of ``food'' given in section 201(f) of
the FD&C Act applies to this term as used in this rule. Under section
201(f), the term ``food'' means (1) articles used for food or drink for
man or other animals, (2) chewing gum, and (3) articles used for
components of any such article. Shipping and storage equipment that is
meant to contact food is not food and would be regulated exclusively as
``transportation equipment'' under this rule. Therefore, persons
involved in the transportation of such equipment are not shippers,
carriers or receivers of

``food.'' However, the food contact surfaces of such equipment must
comply with any other applicable regulations we have established, e.g.,
food additive regulations, for any components that may migrate into
food under their intended conditions of use.
    (Comment 58) A few comments ask us to exclude food contact
substances as defined in section 409(h)(6) of the FD&C Act from the
scope of this rule by excluding them from the definition of ``food.''
One of the comments notes that we excluded food contact substances from
the definition of ``food'' in the food facility registration
regulations in 21 CFR 1.227(b)(4). It further states that requiring
manufacturers, shippers, receivers, and carriers of food contact
substances to comply with the sanitary transportation requirements
would impose a significant burden with respect to the transportation of
products that present a very low food safety risk and for which any
risk is already effectively managed.
    (Response 58) We partially agree with these comments. In the 1990
SFTA, Congress included food additives along with other substances
defined in the FD&C Act in designating the scope of the regulations
that it directed DOT to issue. We take this to mean that Congress
recognized that food could be made unsafe as a result of insanitary
food additive transportation practices. Food contact substances are
``food additives'' and are also ``food'' as defined in the FD&C Act. In
the absence of language in the 2005 SFTA that explicitly excludes food
contact substances from regulation as food, we would not agree with the
comment's view that food contact substances should not be considered to
be ``food'' within the meaning of this rule.
    However, section 416(c)(1) of the 2005 SFTA states that we shall
prescribe sanitary transportation practices that we determine to be
appropriate in issuing this rule. We, therefore, are revising the
definition of transportation operations to exclude food contact
substances as defined in section 409(h)(6) of the FD&C Act. Factors
inherent to the transportation and downstream handling of food contact
substances, described in this section, would strongly support that
there is little risk of food products becoming adulterated because of
insanitary food contact substance transportation practices. We agree,
as one comment notes, that food contact substances are protected during
transportation with additional outer packaging. In addition, the
pathogenic microorganisms that are deleterious to conventional foods
are not known to be a risk for food contact substances. We also note
that the handling and processing that these substances undergo during
the manufacturing of finished food contact articles, such as curing,
drying, and extrusion, often involve very high temperatures, creating
conditions under which there is little possibility that any
microorganisms that might be present would survive. The nature of
finished food contact articles also ensures that the risk of microbial
contamination is very low. We, therefore, have determined that
requirements under this rulemaking for the sanitary transportation of
food contact substances are not necessary.
8. Food Not Completely Enclosed by a Container
    We proposed to define the term ``food not completely enclosed by a
container'' to mean any ``food that is placed into a container in such
a manner that it is partially open to the surrounding environment.'' We
stated in the proposed rule that examples of such containers would
include an open wooden basket or crate, an open cardboard box, a vented
cardboard box with a top, or a vented plastic bag, but would not
include food transported in a bulk vehicles. We are finalizing this
definition as proposed.
    (Comment 59) One comment objects to our proposed inclusion of food
packaged in vented cardboard cartons with tops as an example of ``food
not completely enclosed by a container.'' Several comments disagree
that the use of vented cartons by the tree fruit industry poses a
measurable risk of contamination to fruit during transportation. One
comment observes that vented cardboard cartons with tops are a commonly
used for cooling fruit and contribute to the maintenance of fruit
quality. According to the comments, vented cartons bearing fruit are
stacked on pallets before being placed in refrigerated trucks by
forklifts, and they are removed the same way and without ever coming
into direct contact with the trucks' interior surfaces. The comments
also assert that it is rare for loads of fruit packaged this way to be
transported with any other food products, further reducing the risk of
cross-contamination or adulteration. Finally, the comments also assert
that no evidence of any threat to food safety has emerged over the many
decades that the tree fruit industry has used these types of cartons
for packaging and transportation.
    (Response 59) We agree that when sanitary transportation practices
are followed in the transportation of tree fruit, there should be no
significant risk of contamination of the product. However, we decline
the request to exclude vented cardboard cartons from the definition of
``food not completely enclosed by a container.'' The purpose of this
rulemaking is to prescribe sanitary transportation practices to ensure
that food does not become unsafe during transportation. We have
determined that it is necessary to establish requirements related to
the transportation of foods not completely enclosed by a container,
including food transported in vented cardboard cartons with tops,
because food, including tree fruits, packaged this way could be
susceptible to environmental contamination, for example, if a vehicle
used for transport is not in appropriate sanitary condition for the
transportation operation.
    (Comment 60) One comment states that it is unclear what we mean by
a ``completely enclosed container'' as it relates to storage practices
during loading and transportation operations. The comment asks whether
this means food must be enclosed by a cardboard box or a plastic
wrapped pallet, or whether food must be enclosed by a moisture
impervious container such as ones made out of heavy plastic, glass or
metal. The commenter states that it has seen ``extreme examples of
cross contamination, such as raw poultry on ice, stored above fresh
produce with bloody ice falling into the produce.'' The commenter asks
us to provide clearer language.
    (Response 60) We consider a ``completely enclosed container'' to be
one that physically separates the food from the environment and
functionally protects the food from environmental contamination during
transportation. We would not consider items such as pallet wrap, which
have the primary purpose of facilitating the handling of pallets, to be
food containers. We provided examples of such containers in the
proposed rule (79 FR 7006 at 7015), e.g., a metal can, a glass or
plastic bottle, or a sealed bag or box.
9. Full-Time Equivalent Employee
    ``Full-time equivalent employee'' is a new term in this rule and is
used to represent the number of employees of a business entity for the
purpose of determining whether the business is a small business. The
number of full-time equivalent employees is determined by dividing the
total number of hours of salary or wages paid directly to employees of
the business entity and of all of its affiliates and subsidiaries by
the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52
weeks). If the result is not a whole number, round down to the next
lowest whole

number. We are adding this term to the rule to clarify its use in the
revised definition of ``small business'' in this rule. The use of this
term is consistent with the use of the same term in the preventive
controls rules for both human and animal food.
10. Loader
    We are adding the term ``loader'' to this rule and specifying that
it means a person that loads food onto a motor car or rail vehicle used
during transportation operations. We are adding this term in response
to comments that indicated that there were certain functions assigned
in the proposed rule that were typically performed by a segment of the
transportation industry known as loaders and so we have added this
function to the rule.
11. Microorganisms
    We proposed to define the term ``microorganisms'' to mean yeasts,
molds, bacteria, viruses, protozoa, and microscopic parasites and to
include species that have public health significance. We proposed to
define the term ``undesirable microorganisms'' to include those
microorganisms that are of public health significance, that subject
food to decomposition, that indicate that food is contaminated with
filth, or that otherwise may cause food to be adulterated. We have
removed this term as explained in the response to Comment 61.
    (Comment 61) One comment states that although these definitions are
familiar from the existing food cGMP regulations at 21 CFR part 110
(which have been revised in the preventive controls for human food
final rule and are now in 21 CFR part 117, subpart B), they provide
little assistance for purposes of identifying foods that can support
the rapid growth of undesirable microorganisms in the absence of
temperature controls. Other comments state that we should clarify that
microorganisms that have only the potential to cause spoilage, without
posing food safety risks, should not be excluded from these definitions
of microorganisms.
    (Response 61) We included a definition for the term
``microorganisms'' in the proposed rule that was to be applied to
requirements in proposed Sec. Sec.  1.906 and 1.908 that addressed
measures necessary to prevent conditions that could lead to the rapid
growth of undesirable microorganisms in food because of the use of
insanitary transportation equipment and transportation practices. As we
explained in our response to Comment 89, we have revised the language
in these sections of this final rule to no longer refer to the term
``undesirable microorganisms.'' As a result of this revision, there is
no longer a need to include a definition for the term
``microorganisms.''
12. Non-Covered Business
    We proposed to define the term ``non-covered business'' to mean a
shipper, receiver, or carrier engaged in transportation operations that
has less than $500,000 in total annual sales. We have changed the
annual sales qualifier in this provision to an annual revenue qualifier
because under this rule, this definition applies to firms, e.g.,
loaders that do not sell products. In addition, to be consistent with
the models used in other FSMA rulemakings (e.g., the preventive
controls final rules) for similar calculations, we have revised this
definition to provide that the annual revenue calculation is based upon
an average value for 3 years preceding the applicable calendar year,
and allows for adjustment for inflation.
    (Comment 62) We received a large number of comments regarding this
proposed provision. Most of them oppose granting any kind of size-based
exclusion. Several themes emerge from the comments that we received
opposing the inclusion of a size-based exclusion in this rule. Many of
the comments ask us to create a ``very small'' category of businesses
which would be subject to fewer requirements than other firms. Some of
these comments state that the proposed exclusion provision leaves the
most problematic group of transporters, operators of small box trucks,
uncovered by this rule, citing the findings that we discussed in the
proposed rule (79 FR 7006 at 7024), of the 2007 Interstate Food
Transportation Assessment Project (Ref. 6). Some comments expressed the
view that that all members of the food supply chain, regardless of
size, must share responsibility in ensuring food safety. Some comments
criticize the proposed exclusion for lacking a statutory basis, for not
being risk-based, or for lacking merit and being unnecessary. One
comment opposes the proposed exclusion on the grounds that we have
failed to explain why the proposed rule's requirements would be
prohibitive for those firms capable of qualifying for the exemption.
Other commenters state that we should not grant any exclusions because
the proposed requirements are similar to food cGMPs, which we impose on
almost all food processors.
    (Response 62) We articulated our reasons in the proposed rule (79
FR 7006 at 7014) for excluding certain businesses, i.e., a ``non-
covered business,'' from the requirements of this rule. We stated that
we want to treat firms subject to this rule comparably to those firms
that are subject to the FSMA preventive controls rules. We also stated
that we want to treat carriers, who are not subject to the preventive
controls rules, in the same manner as we treat other firms engaged in
food transportation operations that are also subject to this rule. We
chose to do this by providing an exclusion for these businesses,
recognizing that their transportation operations are also, and will
continue to be, covered under the adulteration provisions and other
applicable provisions of the FD&C Act and all of our applicable
implementing regulations. In light of this, and recognizing businesses
that would qualify for this size-based exclusion would have fewer
resources to dedicate to complying with this rule, we chose to exclude
these businesses from this rule rather than create a separate category
of very small business that would be subject to fewer requirements than
other firms. We estimate that the removal from coverage of entities
less than $500,000 in average annual revenues, as we have set out in
this final rule, would result in only about 5 percent of food shipments
not being covered by this rule. The risk of any foodborne outbreak
associated with this narrow range of shipments therefore is, thus,
necessarily limited in scope. Notwithstanding the information on small
box trucks contained in the 2007 Interstate Food Transportation
Assessment Project, we are not aware of data that supports the
assertion of some comments that shipments by the smallest firms, i.e.,
those that would meet the definition of a non-covered business, present
a greater food safety risk than those of larger firms. Comments we
received on the proposed rule have not presented any information tying
risk of adulteration to firm size to persuade us that we should apply
the requirements of this rule to the businesses we proposed to exclude.
Operators of small box trucks would be covered unless they meet the
definition of a non-covered business.
    To further expand upon our thinking, we note that the preventive
controls rules exempted ``qualified facilities'' as defined by the
FSMA, from the requirement for hazard analysis and risk-based
preventive controls and instead established very limited requirements
(essentially statutorily mandated attestations by the firm to FDA)
specific to this category of

facilities, e.g., ``very small businesses,'' as defined in these rules.
While the 2005 SFTA does not address ``qualified'' facilities and does
not require us to include provisions in this rule for very small
businesses, we determined in considering the costs and benefits of this
rule, that a category of businesses, i.e., ``non-covered'' businesses,
should remain subject to the adulteration provisions and other
applicable provisions of the FD&C Act and applicable implementing
regulations, but not be subject to the requirements of this rule. We
point out that many non-covered businesses that are shippers, loaders
and receivers, would be subject to the cGMP provisions in Sec.  117.93
of the preventive controls rule that address transportation practices.
We also point out that our proposed approach would not absolve a non-
covered business from the responsibility to conduct its transportation
operations in compliance with the adulteration provisions of the FD&C
Act, upon which this rule is based.
    Therefore we are retaining the exclusion for non-covered businesses
from the requirements of this rule. However, to further promote the
application of sanitary transportation practices throughout the
industry, we will also consider establishing guidance for
transportation activities carried out by non-covered businesses.
    (Comment 63) Some comments are concerned about possible unintended
consequences potentially associated with size-based exclusions,
including confusion that could result when a covered firm attempts to
do business with a non-covered firm, or the exit of small firms from
the food transportation industry because shippers may discontinue doing
business with carriers that are not subject to the rule. One comment
opposed to the proposed provision expresses the view that small
shippers, loaders, carriers, and receivers excluded from the rule based
on size still could be penalized if the food they are transporting
becomes adulterated because any party that introduces or receives an
adulterated food product in interstate commerce may be held legally
responsible.
    (Response 63) Firms engaged in food transportation, including those
exempt from this rule, must comply with all of the generally applicable
requirements of the FD&C Act, including those that prohibit the holding
of food under insanitary conditions whereby the food may become
contaminated with filth or be rendered injurious to health. While
differing requirements have the potential to affect business
relationships among firms and their interactions with regulatory
agencies, we believe that agencies and the marketplace can adapt
appropriately, and that firms will not be unduly inconvenienced by
them. Furthermore, if firms that are not covered by this rule because
of their size voluntarily chose to meet the rule's requirements, for
example, for competitive business purposes, there are resources, such
as FDA and industry issued guidance on sanitary food transportation and
training in sanitary food transportation practices, available to them.
    (Comment 64) One comment states that the proposed exclusion may
have the unintended consequence of motivating food transportation firms
to create subsidiary companies for the purpose of dispersing their
annual sales so that each newly created, related company would have
less than $500,000 in annual sales, and therefore qualify for the
exclusion.
    (Response 64) In the proposed rule (79 FR 7006 at 7014) and in the
responses to the previous comments, we articulated our reasons for
excluding a ``non-covered business'' from the requirements of this
rule. We cannot discount the possibility that some firms might form
separate businesses to bring their disaggregated annual sales below the
threshold for a non-covered business, but this is not likely to be a
common occurrence and such separation may not be advantageous for
business reasons. Therefore, we do not believe that the possibility
poses a reasonable basis upon which to modify this provision of the
rule.
    (Comment 65) Among comments that we received in support of the
proposed exclusion for non-covered businesses, some support keeping the
provision at its proposed threshold of $500,000 in total annual sales.
Another comment supports lowering the annual revenues threshold to
$10,000, while a few support increasing it to $1,000,000. One comment
supports the exclusion, but suggests defining a non-covered business
exclusively as one that employs fewer than 500 people, regardless of
annual revenues. According to this comment, annual revenues can vary
from firm to firm, depending on the food products involved, for
example, the differences between the prices of commodity items and
premium or gourmet items. This comment proposes using a threshold of
$1,000,000, consistent with the highest threshold in the proposed
preventive controls for human food rule, in the event we decline to
define a non-covered business in terms of the number of people
employed. Another comment supports an increase in the threshold without
explicitly suggesting a new one. Finally, one comment supporting the
exclusion provision asks us to explicitly state that it would extend to
foreign firms engaged in food transportation activities.
    (Response 65) We explain our reason for retaining the exclusion of
non-covered businesses from the requirements of this rule in our
response to Comment 62. We are retaining the threshold for a non-
covered business as a total annual revenues based threshold at the
$500,000 level as proposed; however, we are allowing for adjustment for
inflation and for basing the calculated value on average annual
revenues, calculated on a rolling basis, during the 3 preceding years.
We estimate that removing firms below this threshold from coverage by
the rule would result in about 5 percent of food shipments not being
covered by this rule
    To define a non-covered business as one not exceeding $10,000 in
total annual sales, as one comment suggests, would not be consistent
with our stated purpose of extending comparable treatment to firms
subject to this rule and similarly situated firms subject to the FSMA
preventive controls rules. A $10,000 total annual sales limit
corresponds to a business of much smaller size than one that could be a
``qualified facility'' as defined in the preventive controls rules and
such a threshold would likely result in 100 percent of food shipments
being covered by the rule.
    We considered changing the total annual sales limit for a non-
covered business to $1,000,000, which would be consistent with the
definition of very small business in the Human Food Preventive Controls
rule (the Animal Food Preventive Controls rule defined very small
business as less than $2,500,000), but chose not to do so because it
would result in about 10 percent of food shipments not being covered by
this rule. While selecting a value of $1,000,000 for this rule would be
more consistent with the Preventive Controls rules, which we believe to
be a desirable endpoint, the percentage of food shipment not covered by
this rule at that threshold would be vastly different than the less
than 0.6 percent of food not covered by the Preventive Controls rules.
We weighed the cost to this category of small businesses against the
risk of adulteration, and determined that excluding 5 percent of
shipments from coverage by this rule was more appropriate, because it
would expose less food to any potential risk arising from non-coverage
by this rule.

    We decline to establish the threshold for a non-covered business in
terms of fewer than 500 people employed, because that threshold is the
basis of the definition of a ``small business'' under this rule, which
is a covered business category.
    (Comment 66) One comment asks us to add an additional exclusion for
food establishments that sell to qualified end users, as defined by the
FSMA preventive controls rules, as a separate category within the
definition of ``non-covered business,'' or as a separate exclusion,
rather than requiring this category of businesses to undergo the waiver
process provided for in this rule. The comment states that such an
exclusion would follow FSMA's mandate for the preventive controls rules
and produce safety rule to be flexible, and scale- and supply-chain
appropriate. The comment states that this mandate includes content
requirements for the preventive controls rules and the produce safety
rule to provide sufficient flexibility to be practicable for all sizes
and types of businesses and facilities, and to provide modified
requirements for small and mid-sized farmers and facilities engaged
primarily in selling food through direct-to-consumer supply chains.
    (Response 66) The Preventive Controls rules for human and animal
food provide for modified requirements for qualified facilities.
Qualified facilities are defined in those rules to mean a facility that
is a very small business (i.e., averaging less than $1,000,000 of
annual sales of human or animal food), or a facility to which both of
the following apply: (1) The average annual monetary value of the food
manufactured, processed, packed or held at such facility that is sold
directly to qualified end-users exceeded the average annual monetary
value of the food sold by such facility to all other purchasers; and
(2) the average annual monetary value of all food sold was less than
$500,000. A qualified end-user is defined to mean the consumer of the
food or a restaurant or retail food establishment that: (1) Is located:
(i) In the same State or the same Indian reservation as the qualified
facility that sold the food to such restaurant or establishment; or
(ii) not more than 275 miles from such facility; and (2) is purchasing
the food for sale directly to consumers at such restaurant or retail
food establishment. In sum, facilities that sell less than $1,000,000
of food are subject only to the modified requirements of the Preventive
Controls rules, whether or not those sales are to qualified end users.
    As explained in our response to previous comments, we have
attempted to make consistent, to the extent possible, the size-based
``exemption'' from this and the Preventive Controls rules. Because we
did not ``exempt'' from the preventive controls rules (i.e., subject to
only the modified requirements) all firms that make sales to qualified
end users, as suggested by the commenter, we are similarly declining to
do so here. As a practical matter, however, the $500,000 exemption
provided for in this rule applies whether or not the sales are to
qualified facilities, as does the $1,000,000 threshold in the
Preventive Controls rules. We explain in the preceding comment response
why we did not select a $1,000,000 threshold in this rule.
    Nevertheless, we stated in the proposed rule (79 FR 7006 at 7029-
7030) that we had tentatively determined that it would be appropriate
to waive the applicable requirements of this rule, if finalized as
proposed, with respect to retail food establishments holding valid
permits, only when engaged in transportation operations as receivers,
or as shippers and carriers in operations in which food is relinquished
to consumers after transportation from the establishment. As we stated
in section III.E., we intend to publish a waiver in the Federal
Register addressing this class of persons prior to the compliance date
of this final rule.
13. Person
    In the proposed rule we defined ``person'' to mean individuals,
partnerships, corporations, and associations. We have deleted this
definition from this final rule, however, because Sec.  1.904 of the
rule clearly states that the definitions and interpretations of terms
in section 201 of the FD&C Act are applicable to such terms when used
in this rule. We did not receive any comments on our definition of the
term ``person.''
14. Pest
    We proposed to define the term ``pest'' to mean any objectionable
animals or insects including birds, rodents, flies, and larvae. We are
finalizing this definition as proposed.
    (Comment 67) One comment states that, while the utmost care is
taken to ensure that natural pests of tree fruit are eliminated during
the packing process, the presence of naturally occurring plant pests in
tree fruit is not an indication of contamination and, if found, should
not be cause for concluding that the tree fruit is adulterated.
    (Response 67) There is no provision in this rule by which we would
automatically regard the presence of naturally occurring plant pests in
tree fruit as grounds for determining that the food is unsafe. We do
not intend to establish a standard for the adulteration of tree fruit
because of the presence of naturally occurring pests. As we discuss in
response to Comment 89, we have revised the provisions of the proposed
rule that incorporated the adulteration provisions of the FD&C Act in
addressing transportation equipment and operations. As we explained, we
did this to avoid misinterpretation of this rule and to clarify that
this rule only requires that transportation operations, including the
use of transportation vehicles and equipment, must be conducted under
conditions and controls necessary to prevent the food from becoming
unsafe, i.e., adulterated within the meaning of sections 402(a)(1), (2)
and (4) of the FD&C Act.
15. Receiver
    We proposed to define ``receiver'' to mean any person who receives
food after transportation, whether or not that person represents the
final point of receipt of the food. We further clarified in the
proposed definition that the receiver may also be a carrier or a
shipper and that a receiver does not include an individual consumer or
a person who holds food on behalf of an individual consumer and who is
not also a party to the transaction and not in the business of
distributing food. In the final rule, as explained in the discussion of
Sec.  1.908(a)(1), we have added a general provision about the multiple
roles that can be played by a single entity to replace the separate
provisions we had included in the proposed definitions of ``carrier,''
``shipper'' and ``receiver.'' We have also removed the specificity
about the consumer or someone acting on his or her behalf because it
was inappropriate for a definition, but we affirm that these entities
are not subject to this definition. We did not receive any comments on
our proposed definition of ``receiver.''
16. Shelf Stable
    We proposed to define the term ``shelf stable'' to mean a food that
can be stored under ambient temperature and humidity conditions and, if
the package integrity is maintained, will not spoil or become unsafe
throughout its storage life. Examples of shelf stable food include
canned juices, vegetables, and meat, bottled water, and dry food items

such as rice, pasta, flour, sugar, and spices. We are removing this
definition from the final rule because the proposed exclusion (in the
definition of ``transportation operations'') of ``shelf stable food
that is completely enclosed by a container'' has been changed to apply
to ``food that is completely enclosed by a container except a food that
requires temperature control.'' We made this revision in the definition
of ``transportation operations'' because, as we have previously
explained, we have narrowed the focus of this rule to adulteration
linked to food safety.
    While some non-shelf-stable foods that are completely enclosed by a
container and do not require temperature control for safety, e.g.,
pasteurized orange juice, may spoil and become unfit for consumption if
temperature abused, such a food will not become unsafe. The
adulteration of food in such a circumstance, due to spoilage, would
have been subject to this rule as proposed. This is no longer the case,
nonetheless, FDA has authority under existing adulteration provisions
in section 402 of the FD&C Act to address such a circumstance. We are
addressing comments that spoke to the proposed exclusion of shelf
stable food from the transportation operations definition to better
inform readers about the scope of foods that would fall within the
broader exclusion in revised definition.
    (Comment 68) One comment states that we should clarify the
definition of ``shelf stable food'' so that it clearly applies to all
shelf stable foods, including food ingredients such as flavoring
substances and compounded flavors. The comment states that our proposed
definition for ``shelf stable foods'' may be construed too narrowly
because the examples we provided in the proposed language imply that
the ``shelf stable food'' definition applies only to finished food
products like canned juice, canned vegetables, or bottled water. The
commenter voiced the view that it is unclear from the proposed rule
whether we intend for that list to be exhaustive or exclusive. The
comment asks us to ensure that the definition clearly applies to all
foods, including food ingredients that meet the ``shelf stable food''
definition. Another comment recommends that we include examples of
animal food, such as packaged animal food, in the definition of shelf
stable food.
    (Response 68) We agree with these comments and affirm that food
``completely enclosed by a container,'' as expressed in the definition
of ``transportation operations'' encompasses food ingredients as well
as finished food products for humans and animals. We are not including
examples of such foods because this category of food is extremely
broad, making any such list limited relative to the whole, and we
believe that the revised definition describes the types of foods
encompassed by this exclusion in an understandable manner.
    (Comment 69) Some comments state that shippers and carriers need
more clarity on which food shipments are shelf stable. One comment
states that the proposed definition provides a broad description of
what constitutes shelf stable food but does not contemplate the diverse
characteristics of food items, such as shelf-lives, packaging, and
handling requirements that shippers and carriers will need to consider
when determining whether food is shelf stable. The comment, for
example, asks: How long the shelf-life of an item must be before it is
considered shelf stable; whether packaging susceptible to humidity or
humidity abuse would be considered to be fully enclosed, i.e., whether
we would question if packaging susceptible to humidity or humidity
abuse is capable of maintaining package integrity; and whether we would
consider food items subject to spoilage when frozen and thawed at room
temperature to be shelf stable? Another comment asks us to affirm that
boxes with flaps that are sealed by tape qualify as acceptable
packaging under this definition. This comment also asks us to affirm
that this definition does not only apply to food products bound for
retail outlets, but would also apply to food being shipped from a
supplier to a re-packer. Another comment states that we should require
shippers or loaders to give carriers unambiguous notice when they are
given shipments of food that are not shelf stable.
    (Response 69) The shipper of the food, who often is also its
manufacturer, would be the person who would be expected to know whether
a food falls within the scope of the exclusion from the definition of
``transportation operations'' applicable to food completely enclosed by
a container and that does not require temperature control for safety.
We would expect that the shipper would take the steps required under
this rule with respect to the transportation of any food that falls
within the scope of this definition. This rule does not require the
shipper to inform the carrier that a shipment of food is not subject to
this rule because it is excluded from the scope of this definition.
    In addressing the other questions raised by these comments we can
state: (1) The requirements applicable to any food subject to this rule
apply during transportation to all receivers that are subject to this
rule, not just food bound for retail outlets; (2) In general, we would
consider boxes with flaps sealed by tape to be a container that
completely encloses the food; (3) The transportation of frozen food is
not subject to this rule. As we stated in the proposed rule for
preventive controls for human food (78 FR 3646 at 3774), the
temperature and time required for a frozen food to become unsafe if not
maintained in the frozen state would result in significant quality
issues for the food before posing any safety risk, and as we discuss
elsewhere in this final rule, we have narrowed the focus of this rule
to adulteration linked to food safety; (4) There are packages which
physically separate food from its surrounding environment that,
nonetheless, allow for oxygen and atmospheric moisture exchange (e.g.,
paper, cardboard) under reasonably anticipated storage conditions
during transportation, and for which we would regard the food to be
completely enclosed by a container because the container would protect
the food from any contamination that could directly enter the food from
the environment; and (5) If a shelf stable food's container is
subjected to abusive storage conditions during transportation which may
compromise its package integrity and allow moisture to enter the food,
the food product is not within the scope of the ``transportation
operations'' definition, however, we would make a case-by-case
determination as to whether the food complies with the requirements of
FD&C Act, particularly, section 402(a)(4) which states that ``a food
shall be deemed to be adulterated if it has been prepared, packed or
held under insanitary conditions whereby it may have become
contaminated with filth or whereby it may have been rendered injurious
to health.''
17. Shipper
    We proposed to define the term ``shipper'' to mean a person who
initiates a shipment of food by motor vehicle or rail vehicle. We
further clarified in the proposed definition that the shipper would be
responsible for all functions assigned to a shipper in this subpart,
even if they are performed by other persons, such as a person who only
holds food and physically transfers it onto a vehicle arranged for by
the shipper, and that a shipper may also be a carrier or a receiver if
the shipper also performs those functions as defined in this subpart.
We are finalizing a simplified definition of ``shipper'' to mean a
person who arranges for the

transportation of a food by a carrier or multiple carriers
sequentially. A ``shipper'' could be a manufacturer or a freight
broker. In the final rule, as explained in the discussion of Sec.
1.908(a)(1), we have added a general provision about the multiple roles
that can be played by a single entity to replace the separate
provisions we had included in the proposed definitions of ``carrier,''
``shipper'' and ``receiver''. We explain our consideration of comments
and our reasons for revising the final definition in the responses to
Comment 70.
    (Comment 70) Several comments oppose defining a shipper as the
person who ``initiates'' transportation. One comment states that the
term is unnecessarily broad and would create confusion about who is
subject to the shipper requirements. Another comment states that the
meaning of the proposed definition is unclear because shipments of food
can be initiated by many different types of persons during the
transportation process, such as manufacturers, distributors, brokers
(parties who arrange for the transportation of food held by other
parties), and retailers. Another comment states that the shipper
definition should describe the person who performs an activity directly
related to the transportation process.
    Several comments suggest changes to the proposed ``shipper''
definition. Some stated that the shipper should be the person who
physically loads or orders the loading of a motor vehicle trailer or
railcar. Some comments state that the shipper should be the
manufacturer of the food because that person is most knowledgeable
about all relevant factors concerning sanitary transportation of the
food. One comment states that the shipper should be the person who
decides to ship a food product and sets the transportation process in
motion.
    Other comments state that the shipper should be the person who owns
the food at the time of shipment. One of these comments notes that
product owners can best meet the responsibilities assigned to a shipper
under the proposed rule even when another party arranges for the
transportation of the shipment. The comment states that it is common
industry practice for owners of the product to provide third-party
logistics providers with instructions for the conditions required for
shipments. Several comments advocating these revisions state that their
suggested changes would clarify which entities in the transportation
chain must meet this rule's requirements for shippers.
    Other comments state that the shipper definition should not place
shipper responsibilities on persons such as brokers because they lack
knowledge about food safety and sanitary food transportation practices.
One comment stated that third-party logistics providers, such as
distribution centers, should not be subject to the shipper definition.
The comment states that, although third-party logistics providers
arrange for the transportation of food, they lack knowledge about food
safety and rely on product owners to provide that information in
establishing sanitary transportation conditions.
    One comment stated that brokers are nowhere near the location where
a shipment of food is being loaded into a motor vehicle trailer or
railcar and, therefore, it is impossible for them to carry out duties
assigned to a shipper, such as visually inspecting a vehicle prior to
loading. A related comment asserts that facilities that hold the food
for which shipment is arranged by an offsite shipper should be
responsible for proper storage, handling, and loading or unloading of
the food in accordance with FDA and customer requirements. Another
comment addressed concerns that under the proposed shipper definition,
shipper responsibilities would fall upon receivers who purchase food
under a FOB contract in which title to the food passes at the seller's
location, even though the receiver would not be present at the time of
loading, and therefore could not meet this rule's shipper requirements.
The comment states that the entity that physically loads the goods,
instead of the receiver, is in the best position to meet a shipper's
obligations, such as maintaining written procedures and records, and
inspecting vehicles and transportation equipment prior to loading.
    (Response 70) We agree that our proposed definition for a shipper,
i.e., the person who ``initiates a shipment of food'' is not
sufficiently clear to identify the person who would be subject to this
definition because the term ``initiates'' is not sufficiently precise.
In considering how to revise this definition, we note that under the
proposed rule, the shipper would be responsible for functions involving
communication with the carrier that take place before transportation
occurs (proposed Sec.  1.908(b)(1) and (3)), and with functions
involving the inspection of vehicles and transportation equipment that
take place prior to loading (proposed Sec.  1.908(b)(2) and (4)).
    We first considered which person would be best suited to perform
those functions, which involve specifying to the carrier all necessary
sanitary requirements for the carrier's vehicle and transportation
equipment to ensure that the vehicle is in appropriate sanitary
condition, and specifying temperature control parameters to the carrier
if the food requires temperature control during transportation.
Inasmuch as these functions involve communicating important information
to the carrier about operating conditions during transportation, we
have determined that the appropriate person to perform these functions
is the person who makes the transportation arrangements with the
carrier because this person communicates directly with the carrier and
can directly provide the carrier with the information required by this
rule. While the owner or the manufacturer of the food, or the person
who loads the food onto a vehicle, may possess this information, we do
not regard these persons as best suited to bear responsibility for
providing information to the carrier if neither of these persons
actually makes the transportation arrangements with the carrier.
    We also considered whether a shipper would need to be knowledgeable
about food safety and sanitary transportation practices to perform
functions that involve communication with a carrier before
transportation occurs. While we agree that persons such as brokers, who
arrange for transportation of food held by other parties, likely do not
possess the degree of knowledge about food safety that a food
manufacturer would, we also agree that current industry practices
demonstrate that these persons, e.g., brokers and other third-party
logistics providers, obtain the vehicle preparation and sanitary
transportation information, as needed, for example, from manufacturers,
to provide to the carriers. Therefore, we do not regard brokers and
other third-party logistics providers as inappropriate persons to
perform the functions assigned to a shipper that take place before
transportation occurs.
    We have determined, therefore, that the person who arranges for the
transportation of food by a carrier is best suited to perform the
functions of a shipper that take place before transportation occurs and
that the person can be someone who only arranges for the transportation
of food, for example, a broker, as long as they have, or obtain, the
necessary food safety information. We have incorporated these
provisions into the revised definition of the term ``shipper'' in Sec.
1.904.
    We also considered the second function assigned to the shipper in
our

proposed definition, i.e., those involving the inspection of vehicles
and transportation equipment and confirming that the shipper's
specifications have been met, e.g., for cleaning and pre-cooling, which
take place before food is loaded onto a conveyance. We agree with
comments that state that a shipper who is not on site at the time of
loading cannot readily perform these functions, and we do not believe
that it would be practical to require an offsite shipper to arrange for
a representative of the shipper to be present to perform these
inspections. We therefore agree with the comment that states that these
functions can be readily performed by the person who loads vehicles or
transportation equipment if that person is not the shipper, provided
that this person also receives the specifications for vehicle
preparation that the shipper provides to the carrier under Sec.
1.908(b)(1) and (2), because that person is on site and would typically
be associated with the facility in which the food is held prior to
loading. Further, the person likely would be knowledgeable with respect
to basic sanitation practices applicable to loading food into vehicles
and equipment because of his responsibilities in operating the
facility. We also note that facilities that are subject to our cGMP
requirements already have similar responsibilities under 21 CFR 117.93.
This provision requires that storage and transportation of food must be
under conditions that will protect against allergen cross-contact and
against biological, chemical (including radiological), and physical
contamination of food, as well as against deterioration of the food and
the container.
    Therefore, we have determined that the shipper should not be
responsible for the functions that person would have been assigned
under Sec.  1.908(b)(2) and (4) of the proposed rule involving
inspection of vehicles and transportation equipment that take place
prior to loading. We are defining an additional term, the ``loader'' as
described previously in this section to designate the person who will
be responsible for those functions under this rule under Sec.
1.908(c), which has been redesignated in this final rule as
``Requirements applicable to loaders engaged in transportation
operations.''
18. Small Business
    We proposed to define the term ``small business'' to mean a
business subject to Sec.  1.900(a) that employs fewer than 500 persons,
except that for carriers by motor vehicle that are not also shippers
and/or receivers, this term would mean a business subject to Sec.
1.900(a) that has less than $25,500,000 in annual receipts. In the
final rule, we have revised the threshold for motor vehicle carriers to
$27,500,000, consistent with the recent change made by the Small
Business Administration in the size based standard for trucking firms
in 13 CFR part 122.201. We have revised this final rule to base the
calculation for ``small business'' on ``full-time equivalent
employees.'' We used the same approach to calculate full-time
equivalent employees for the purpose of this rule as we used to
calculate full-time equivalent employees in the preventive controls
rules (e.g., see response to comment 140 in the preventive controls for
human food final rule (80 FR 55908 at 55962), and also the discussion
of the definition of a full-time equivalent employee in that final rule
(80 FR 55908 at 55962)). In conjunction with this revision and as
previously described, we have established a definition for ``full-time
equivalent employee'' as a term used to represent the number of
employees of a business entity for the purpose of determining whether
the business qualifies as a small business for the purpose of
establishing its compliance date. Therefore, we are modifying the
definition of ``small business'' to use the term ``500 full-time
equivalent employees'' rather than ``500 persons.''
    (Comment 71) One comment states that the proposed definition of a
small business is overly broad and would unduly delay the timeframe for
compliance with this rule for the majority of the carriers.
    (Response 71) We do not agree that our proposed definition is
overly broad. As we explained in the proposed rule (79 FR 7006 at
7014), our proposed definition for a small business was based upon the
applicable size-based standards issued by the U.S. Small Business
Administration (SBA) under 13 CFR part 121. We believe that allowing
businesses that are formally classified ``small'' by the SBA additional
time to come into compliance with the requirements of this rule is
appropriate. We also believe that small businesses that are able to
come into compliance before their compliance date would do so and use
that fact for promotional purposes with prospective customer's, e.g.,
shippers, rather than delay compliance with this rule.
    (Comment 72) A comment stated that we should exempt Class II and
Class III railroads (these classifications generally relate to short
line and regional railroads respectively) with fewer than 400,000 labor
hours from the requirements of this rule. The comment states that the
400,000 labor hours standard has been used by DOT from time to time as
the standard for exempting small railroad carriers from regulatory
requirements. The comment states that railroads are extremely capital
intensive as they pay for their right of way and, typically, small
business railroads invest much of their revenue into ties and track
structure, equipment maintenance and inspections. The comment further
states that shifting the responsibility for the sanitation of railcars
carrying food products to the small railroad will be burdensome because
these entities currently do not clean or sanitize cars or maintain
facilities for such operations. Further, the comment states that it is
difficult for railroads to know the storage condition of railcars, and
that they cannot be reasonably held accountable for the storage
conditions of cars in many circumstances of use.
    (Response 72) As discussed in our response to Comment 53, we have
revised the definition of the term ``carrier'' in this final rule, in
part, because our proposed definition would have established
requirements that railroad operators, typically, cannot meet. We stated
that under the revised definition of the term ``carrier'' in this final
rule, a railroad operator only bears responsibilities under this rule
when it has agreed to do so in a written contract with the shipper. We
believe that this revision addresses the concerns of this comment.
19. TCS Food
    We proposed to define the term ``time/temperature control for
safety (TCS) food'' to mean a food that requires time/temperature
control for safety to limit pathogenic microorganism growth or toxin
formation. As we explained in our response to Comment 111, we have not
retained this definition in the final rule. We, therefore, do not need
to address comments that we received that suggest revisions or
clarifications to the proposed definition.
20. Transportation
    We proposed to define ``transportation'' to mean any movement of
food in commerce by motor vehicle or rail vehicle. We did not receive
any comment on our proposed definition and are finalizing it as
proposed.
21. Transportation Equipment
    We proposed to define the term ``transportation equipment'' to mean
equipment used in food transportation operations, other than vehicles,
for example, bulk and non-bulk containers, bins, totes, pallets, pumps,
fittings,

hoses, gaskets, and loading and unloading systems. Transportation
equipment also includes a railcar not attached to a locomotive or a
trailer not attached to a tractor. We are finalizing this definition as
proposed with the exception of the removal of the phrase ``other than
vehicles,'' which we are removing for clarity and the internal
consistency of the definition.
    (Comment 73) One comment asks us to revise the proposed definition
of ``transportation equipment'' to clarify that it encompasses only
such equipment exclusively associated with a transportation conveyance.
The comment states that the proposed definition is overly broad, and
could be interpreted to include structures and equipment normally
associated with storage, load-out, and receiving procedures (such as
loading bins, spouting and other equipment located within a shipper's
or receiver's facility), and not strictly to equipment that directly
facilitates transportation activities. The comment suggests that we use
the following revised definition: ``Transportation equipment means
equipment used in food transportation operations, other than vehicles,
e.g., bulk and non-bulk containers, totes and pallets loaded onto
transportation conveyances, and pumps, fittings, hoses, gaskets,
loading systems and unloading systems that are integral and affixed to
transportation conveyances.''
    (Response 73) We decline this request. The definition of
``transportation equipment'' already specifies that such equipment is
used in transportation operations. While some types of equipment used
in food transportation, such as hopper bins, may also be constructed as
part of a facility, as we state in our response to Comment 52, we would
not consider a hopper bin, that is constructed as part of a facility
and that is used for storage of materials (but not the movement of
food), to be transportation equipment. Therefore, it would not be
subject to this rule.
22. Transportation Operations
    We proposed to define the term ``transportation operations'' to
mean all activities associated with food transportation that may affect
the sanitary condition of food including cleaning, inspecting,
maintaining, loading and unloading, and operating vehicles and
transportation equipment. We further proposed that transportation
operations do not include any activities associated with the
transportation of shelf stable food that is completely enclosed by a
container, compressed food gases, or live food animals and that all
transportation activities involving raw agricultural commodities (RACs)
that are performed by a farm are also excluded from the definition of
the term ``transportation operations.'' We are finalizing the
definition of ``transportation operations'' as proposed with some
additions. As we discuss in section IV.C., concerning our proposed
definition of ``shelf stable,'' which we have not retained in the final
rule, we have amended the definition of ``transportation operations''
to specify that this term does not include activities associated with
transport of a food completely enclosed by a container except a food
that requires temperature control for safety. We have also added that
transportation operations do not include activities associated with
transport of food contact substances as defined in section 409(h)(6) of
the FD&C Act, human food byproducts transported for use as animal food
without further processing, or live food animals except molluscan
shellfish. Finally, we have revised the exclusion for transportation
activities performed by a farm to all transportation activities
performed by a farm, not just those related to the transport of RACs.
We explain our consideration of comments and our reasons for the
revisions in our responses to the next 12 comments.
    (Comment 74) A few comments ask us to consider excluding, or
granting a waiver for, the transportation of food additives and
substances that are generally recognized as safe (GRAS), and their
precursors, from the proposed requirements of this rule. One comment
states that these substances always undergo further inspection,
testing, and processing steps, which minimizes the possibility that
they could render the food ingredient, or the food that the ingredient
is eventually incorporated into, adulterated. One comment states that
exemption or waiving is appropriate because the production and supply
chain for these substances includes controls to prevent contamination
during production, packaging and transport, and is often certified by
third parties. One comment urges us to apply this rule's provisions for
prior cargo disclosures, protections from allergen cross-contact, and
recordkeeping to these substances. The comment expresses the view
however that a shipper should be exempted from even these requirements
if it can demonstrate that its food additives and GRAS substances have
not been transported in containers that have come into contact with any
of the seven major food allergens, either because these products are
not comingled with other foods or because the carrier does not
transport any other food items.
    (Response 74) We decline these requests. We acknowledge that food
additives, GRAS substances, and their precursors may undergo further
inspection, testing, and processing that minimizes the possibility that
they could render food adulterated, or that they may be subject to
controls and third-party certification that address protection of the
substance during transportation. However, this is a broad group of
substances with diverse packaging and transportation practices (e.g.,
bulk shipments), and it is likely that there are substances for which
the controls included in this final rule are necessary to ensure
sanitary transportation, depending upon the nature of the substance,
the method used to transport it, and its intended use. Therefore,
exempting or waiving food additives and GRAS substances and their
precursors from the requirements of this rule would not be appropriate.
However, we have added provisions to Sec.  1.908(a)(3) of this rule to
provide sufficient flexibility to allow persons engaged in the
transportation of these substances to use sanitary transportation
practices that are appropriate for their circumstances.
    (Comment 75) One comment asks us to consider excluding shippers and
carriers who transport byproducts from a processing facility, e.g.,
spent grain from alcoholic beverage production facilities, from this
rule. The comment states that many industries have developed
sustainable and cost-effective ways to use these byproducts as animal
feed. The commenter believes that the new recordkeeping and inspection
requirements proposed in this rule would hinder a beneficial practice
that has worked successfully for many years.
    (Response 75) We have partially accommodated this request in this
final rule by excluding from the definition of transportation
operations, ``human food byproducts transported for use as animal food
without further processing.'' The intent of this new language is to
exclude from the definition human food byproducts that are not further
processed into a manufactured animal feed. Most commonly, we expect
that these byproducts move directly from the human food manufacturer to
the farm, where they are fed directly to livestock, often by spreading
on the ground. We do not intend to exclude from the definition of
transportation operations human food byproducts that are transported to
a business to be used as an ingredient in a manufactured animal food,
or to be further processed in some

way (e.g., rendered) in the production of animal feed. We believe the
scale of the public health risk posed by the former activity to be
minimal, with the byproducts being transported to only one or several
farms, while the scale of the public health risk posed by the latter
would be substantially greater, with the byproducts being manufactured
into large quantities of animal feed, possibly with a wide
distribution. Our concern here is primarily with the potential for
chemical contamination, as we are aware that many of the byproducts
will be heat treated (e.g., rendered) in a way that will minimize the
risk of microbiological contamination.
    With respect to transportation of human food byproducts for further
processing into animal feed, we decline the request to remove such
operations from the definition of transportation operations because we
have determined that this final rule's recordkeeping and inspection
requirements as applied to the transportation of such products are not
burdensome and are appropriate for these types of transportation
operations. The requirements we are establishing in this rule require
that transportation operations be conducted so as to prevent food from
becoming adulterated during transportation. We do not envision, for
example, that carriers who transport spent grain materials to animal
feed manufacturing facilities would have to clean or inspect their
vehicles any more frequently under this final rule than what is already
typically being done to facilitate safe transportation. However, if
carriers haul intervening loads of fertilizer, for example, they would
need to clean their vehicles before transporting spent grain intended
for use as animal feed. In addition, as we explained in our response to
Comment 149 and Comment 160, in Sec.  1.908(e)(4) and (e)(5) of this
final rule, we have revised the proposed previous load and cleaning
reporting requirements for bulk carriers in a manner that will reduce,
and in some cases eliminate, recordkeeping requirements for these
carriers.
    (Comment 76) Several comments support our proposed provision that
would exclude the transport of live animals from the definition of
``transportation operations.'' One comment disagrees with our tentative
conclusion that sanitary transportation practices are not necessary to
prevent live food animals from becoming adulterated during
transportation and our proposal, therefore, to exclude their transport
from the scope of this rule. This comment suggests that transportation
during hot and cold weather, as well as long-distance transport, causes
stress in the animals, resulting in increased shedding of pathogenic
microorganisms in the manure of the animals being transported. The
commenter asserts that these pathogenic microbes may be spread from one
animal to another via physical contact in transportation vehicles,
possibly resulting in a higher percentage of animals arriving at
slaughter facilities with high levels of pathogenic microbes on their
hides or feathers. The comment asserts that the more animals that
arrive at slaughter with pathogens on their hides or feathers, the more
likely that the mitigations applied by the slaughter facilities will be
ineffective. The commenter further asserts that FSIS inspection at
slaughter facilities is inadequate to mitigate this increase in risk
and, therefore, asks us to require the cleaning of transportation
vehicles with disinfectants between animal loads to mitigate the risk.
    (Response 76) We disagree with this comment. We recognize that the
stress of transportation may increase the shedding of pathogenic
bacteria in the manure of animals during transport, but we are not
aware of scientific information that establishes that this leads
directly to an increased level of pathogenic bacteria in food products
originating from animals coming from FSIS-inspected slaughter
facilities that could be controlled by establishing requirements
through this rulemaking. The slaughter facilities handling the
processing of these animals, as well as the regulatory agencies
responsible for oversight of the facilities, such as the FSIS, are
aware of these issues and the procedures they use to process these
animals have been developed with this risk in mind. Slaughter
operations at facilities subject to FSIS jurisdiction, for example, are
already subject to requirements intended to minimize the risk of
adulteration posed by the presence of contaminants on the external
surfaces of live food animals.
    (Comment 77) One comment asks us to apply this rule's waiver
provisions to determine whether to waive requirements for the transport
of live food animals. The comment further asserts that we should use
the waiver procedure, in part, to provide for an additional opportunity
for public comment with respect to the risks that may be associated
with the transportation of live food producing animals.
    (Response 77) We disagree. Section 416(d)(1)(A-B) of the FD&C Act
provides us with the authority to waive any requirement of this rule
with respect to any class of persons, vehicles, food, or nonfood
products, if we determine that the waiver will not result in the
transportation of food under conditions that would be unsafe for human
or animal health, and will not be contrary to the public interest (21
U.S.C. 350e(d)(1)(A-B)). As we discussed in the proposed rule (79 FR
7006 at 7015), we are not aware of food safety concerns related to the
transportation of live food animals intended for slaughter that could
be addressed through this rule's sanitary transportation requirements.
Furthermore, we also address specific concerns the commenter raised
about this issue in our response to Comment 76, and explain why we have
concluded that establishing requirements through this rulemaking to
address those concerns is not necessary. The prerequisite condition for
considering whether we should waive the requirements of this rule for
the transportation of live food animals therefore does not exist, i.e.,
we are not aware of any concerns that would necessitate establishing
sanitary transportation requirements applicable to live food animal
transportation and, therefore, there are no requirements to waive. We,
therefore, have recognized in our definition of ``transportation
operations'' that the transportation of live food animals does not meet
the criteria for inclusion in this definition.
    (Comment 78) One comment on our proposed definition of
``transportation operations'' notes that the exclusion of live food
animals from the definition possibly conflicts with our own guidance
under the National Shellfish Sanitation Program (Ref. 26). It stated
that some states, operating under FDA guidance, require temperature
control during the transport of raw molluscan shellfish between the
harvest area and the first receiver (also known as the ``dealer'').
Participants made similar comments during the public meetings that we
held on this proposed rule.
    (Response 78) We agree that temperature control is necessary to
ensure the sanitary transportation of molluscan shellfish (e.g.,
oysters, clams, mussels) when transported live. As such, and to