this document). It also might not be feasible for the RFE or restaurant
that makes the sale to keep and send shipping records under Sec.
1.1340, especially if the sale happens under circumstances where it may
seem like the purchaser is a consumer. Therefore, Sec.  1.1305(k)(1) of
the final rule provides that, except as specified in Sec.
1.1305(k)(2), subpart S does not apply to either entity when a purchase
is made by an RFE or restaurant from another RFE or restaurant, when
the purchase occurs on an ad hoc basis outside of the buyer's usual
purchasing practice (e.g., not pursuant to a contractual agreement to
purchase food from the seller).
    Instead of the receiving KDEs required under Sec.  1.1345, when an
RFE or restaurant purchases an FTL food on an ad hoc basis from another
RFE or restaurant in accordance with Sec.  1.1305(k)(1), the RFE or
restaurant that makes the purchase must maintain a record (such as a
sales receipt) documenting the name of the product purchased, the date
of purchase, and the name and address of the place of purchase (Sec.
1.1305(k)(2)).
    We conclude that, in these circumstances, this information would be
adequate to enable us to conduct an effective traceback of such a
product. As with other subpart S recordkeeping requirements, RFEs and
restaurants may keep the required information on such purchases in any
records they choose, including paper receipts.
    This partial exemption in Sec.  1.1305(k) does not exempt RFEs and
restaurants from the subpart S requirements when an RFE or restaurant
purchases food from another RFE or restaurant as part of the buyer's
usual purchasing practice, as opposed to on an ad hoc basis. For an ad
hoc purchase of the sort that would be eligible for this partial
exemption, the purchase is generally made through the means utilized by
consumers (e.g., through a check-out line), under circumstances where
the selling RFE or restaurant might assume that the purchaser is a
consumer. When a contractual relationship exists in which one RFE or
restaurant serves as a regular commercial supplier for another RFE or
restaurant, such purchases would be outside the scope of the partial
exemption in Sec.  1.1305(k).
13. Partial Exemption for Farm to School and Farm to Institution
Programs
    Having consulted with USDA in accordance with section 204(d)(6)(A)
of FSMA, we proposed to establish a partial exemption from the subpart
S requirements for farm to school and farm to institution programs
operated under the auspices of the USDA, State agencies, or local
jurisdictions. Proposed Sec.  1.1305(i)(1) would have provided that,
except as specified in proposed Sec.  1.1305(i)(2), the subpart S
requirements would not apply to an institution operating a child
nutrition program authorized under the Richard B. Russell National
School Lunch Act (Pub. L. 116-94) or Section 4 of the Child Nutrition
Act of 1966 (Pub. L. 111-296), or any other entity conducting a farm to
school or farm to institution program, with respect to a

food that is produced on a farm (including food produced and packaged
on the farm) and sold directly to the school or institution. Under
proposed Sec.  1.1305(i)(2), when a school or institution conducting
farm to school or farm to institution activities purchases a food
directly from a farm in accordance with (i)(1), the school food
authority or relevant food procurement entity must establish and
maintain a record documenting the name and address of the farm that was
the source of the food. Proposed Sec.  1.1305(i)(2) specified that the
school food authority or relevant food procurement entity must maintain
such records for 180 days, the same retention period that we proposed
for records maintained under the partial exemption for RFEs purchasing
food directly from a farm in proposed Sec.  1.1305(h).
    (Comment 223) Some comments support the partial exemption for
entities conducting farm to school or farm to institution programs.
Other comments oppose the exemption, maintaining that the exemption
would not be protective of public health because these programs move
large volumes of food to vulnerable populations. The comments provide
examples of food banks that hand out food in parking lots or community
centers that they maintain are not designed to allow for safe handling
and storage of food.
    (Response 223) As discussed in the preamble to the proposed rule,
having consulted with the USDA in accordance with section 204(d)(6)(A)
of FSMA, we believe it is appropriate to adopt this partial exemption
from the subpart S requirements for farm to school and farm to
institution programs, to avoid placing undue burdens on these programs.
While we disagree with comments suggesting that the partial exemption
for farm to school and farm to institution programs is inappropriate,
we recognize the potential that food supplied through such programs can
play a role in foodborne illness. It is because of this that, rather
than fully exempt such programs from the rule, we have established a
partial exemption for such programs. Section 1.1305(l)(1) of the final
rule states that, except as specified in Sec.  1.1305(l)(2), subpart S
does not apply to an institution operating a child nutrition program
authorized under the Richard B. Russell National School Lunch Act or
Section 4 of the Child Nutrition Act of 1966, or any other entity
conducting a farm to school or farm to institution program, with
respect to a food that is produced on a farm (including food produced
and packaged on the farm) and sold or donated to the school or
institution. Under Sec.  1.1305(l)(2), when a school or institution
conducting a farm to school or farm to institution program obtains a
food from a farm in accordance with Sec.  1.1305(l)(1), the school food
authority or relevant food procurement entity must maintain a record
(for 180 days) documenting the name and address of the farm that was
the source of the food. We believe this partial exemption adequately
protects public health while not placing undue burden on such programs,
in accordance with section 204(d)(6)(A) of FSMA.
    (Comment 224) Some comments recommend expanding the partial
exemption in proposed Sec.  1.1305(i) to include food that is donated
by a farm to a school or institution. Other comments ask whether the
proposed exemption would include food that is sold to schools or
institutions through distributors. Other comments suggest that food
hubs and other aggregators who work with small farms are a vital link
in the farm to institution supply chain, often working with very small
farms to aggregate their product into large enough quantities to meet
the needs of large institutional kitchens, and should also be exempt;
these comments maintain that if the food hubs or aggregators are
required to comply, their recordkeeping burden will essentially force
the small farms to comply with the requirements as well. Others suggest
that if food hubs are required to comply with the proposed
requirements, they may cease providing products on the FTL to avoid
recordkeeping required by the rule.
    (Response 224) We recognize that farm to school and farm to
institution programs may receive food through a variety of means,
including via sales or donations, and that this food may be received by
such institutions either directly or indirectly (e.g., through entities
such as brokers, buyers, or school procurement entities). Accordingly,
we have revised the partial exemption to specify, in Sec.
1.1305(l)(1), that it applies when food is sold ``or donated'' to a
school or institution, and that it does not require that a food be sold
``directly'' from a farm to a school or institution, as had been stated
in the proposed rule. To align with this change, we have revised the
partial exemption to state, in Sec.  1.1305(l)(2), that a school food
authority or relevant food procurement entity must maintain a record
documenting the name and address of the farm that was the source of the
food when a school or institution conducting a farm to school or farm
to institution program ``obtains a food'' (rather than ``purchases a
food directly'') from a farm in accordance with Sec.  1.1305(l)(1).
14. Partial Exemption for Food Obtained from Fishing Vessels
    In accordance with section 204(d)(6)(C) of FSMA, we proposed to
adopt a partial exemption from the proposed traceability recordkeeping
requirements for fishing vessels. Proposed Sec.  1.1305(j)(1) provided
that, except as specified in proposed Sec.  1.1305(j)(2), with respect
to a food produced through the use of a fishing vessel, subpart S would
not apply to the owner, operator, or agent in charge of the fishing
vessel. In accordance with section 204(d)(6)(C) of FSMA, we proposed to
define ``fishing vessel'' as that term is defined in section 3(18) of
the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C.
1802(18)), i.e., as any vessel, boat, ship, or other craft which is
used for, equipped to be used for, or of a type which is normally used
for: (1) fishing or (2) aiding or assisting one or more vessels at sea
in the performance of any activity relating to fishing, including, but
not limited to, preparation, supply, storage, refrigeration,
transportation, or processing (proposed Sec.  1.1310). Under this
partial exemption, activities of fishing vessels such as harvesting,
transporting, heading, eviscerating, and freezing fish generally would
not be subject to the proposed recordkeeping requirements.
    Under the proposed exemption, the owner, operator, or agent in
charge of a fishing vessel also would not have to keep tracing records
on the sale and shipment of food produced through the use of the
vessel, except as provided in proposed Sec.  1.1305(j)(2). In the
preamble to the proposed rule, we stated that section 204(d)(6)(C) of
FSMA somewhat ambiguously states that the section 204(d) requirements
applicable to fishing vessels would be limited to certain requirements
for vessels that are required to register with FDA ``until such time as
the food is sold by the owner, operator, or agent in charge of such
fishing vessel.'' We stated that although the phrase ``until such
time'' could be interpreted as meaning that the owner, operator, or
agent in charge of the fishing vessel could be subject to requirements
relating to the sale of the relevant food, we believed it was
appropriate to exempt the owner, operator, or agent in charge of the
fishing vessel from all requirements relating to the relevant food
(except as specified in proposed Sec.  1.1305(j)(2)).
    In accordance with section 204(d)(6)(C) and (F) of FSMA, proposed
Sec.  1.1305(j)(2) specified that if the

owner, operator, or agent in charge of the fishing vessel who receives
the exemption in proposed Sec.  1.1305(j)(1) is required to register
with FDA under section 415 of the FD&C Act with respect to the
manufacturing, processing, packing, or holding of the applicable food,
in accordance with the requirements of subpart H, that person would be
required to maintain records identifying the immediate previous source
of such food and the immediate subsequent recipient of such food in
accordance with Sec. Sec.  1.337 and 1.345. This means that fishing
vessels that must register with FDA because they process fish on the
vessel would be required to comply with the existing subpart J
traceability recordkeeping requirements in Sec. Sec.  1.337 and 1.345,
even though many such fishing vessels are currently exempt from those
requirements under Sec.  1.327(c) (21 CFR 1.327(c)). Affected fishing
vessels would be required to maintain such records for 2 years.
    We have made clarifying changes to this partial exemption, as
discussed in the following paragraphs.
    (Comment 225) Some comments assert that owners, operators, and
agents of fishing vessels should not be exempt from the rule. The
comments maintain that these entities are best placed to maintain
accurate records of the relevant KDEs, that these entities might
already be required to keep such records under national/regional catch
documentation schemes, and that excluding them risks having inaccurate
data later in the supply chain. One comment contends that the exemption
would allow unsafe and illegal seafood to enter the supply chain
because as supply moves between vessels there is opportunity for
laundering of unsafe and illegal catches.
    (Response 225) Section 204(d)(6)(C) of FSMA states that with
respect to a food that is produced through the use of a fishing vessel,
the recordkeeping requirements under this rulemaking shall, until such
time as the food is sold by the owner, operator, or agent in charge of
the fishing vessel, be limited to the requirement that entities who
register with FDA under subpart H must maintain records identifying the
immediate previous source and the immediate subsequent recipient of
such food. As discussed in the preamble to the proposed rule (85 FR
59984 at 59999), we therefore believe it is appropriate to exempt the
owner, operator, or agent in charge of the fishing vessel from all
requirements relating to the relevant food, except for the requirement
to keep certain one-up, one-back records. Section 1.1305(m)(1) of the
final rule therefore states that with respect to a food that is
obtained from a fishing vessel, subpart S does not apply to the owner,
operator, or agent in charge of the fishing vessel, except as specified
in Sec.  1.1305(m)(2). Section 1.1305(m)(1) further states that, except
as specified in Sec.  1.1305(m)(2), subpart S does not apply to persons
who manufacture, process, pack, or hold the food until such time as the
food is sold by the owner, operator, or agent in charge of the fishing
vessel. This language is meant to clarify the application of the
partial exemption in situations where the food is still owned by the
owner, operator, or agent in charge of the fishing vessel, but it is
being handled by a different entity.
    Section 1.1305(m)(2) provides that, with respect to any person who
receives the partial exemption in Sec.  1.1305(m)(1), if such person is
required to register with FDA under section 415 of the FD&C Act, such
person must maintain records identifying the immediate previous source
of such food and the immediate subsequent recipient of such food in
accordance with Sec. Sec.  1.337 and 1.345. Such records must be
maintained for 2 years. We note that the proposed rule used both the
phrase, ``food obtained from a fishing vessel,'' and the phrase, ``food
produced through a fishing vessel.'' In the final rule, for uniformity
and clarity, we use only the phrase, ``food obtained from a fishing
vessel.''
    We believe that the records that the first land-based receiver of
an FTL food obtained from a fishing vessel must keep under Sec.  1.1335
of the final rule (discussed in Section V.L of this document) should
help ensure adequate traceability of food obtained from fishing
vessels. In situations where the first land-based receiver is partially
exempt from subpart S under Sec.  1.1305(m), we believe that any
records required to be kept under Sec.  1.1305(m)(2), in combination
with the records that the first non-exempt receiver will be required to
maintain under Sec.  1.1345(b), should help ensure adequate
traceability of the food.
    Regarding the comment about laundering of unsafe and illegal
catches, we agree that this is an important concern, but it is outside
the scope of this rulemaking, especially in light of the partial
exemption Congress required us to provide for fishing vessels. However,
fishing vessels must comply with all of the laws and regulations that
apply to them, including any laws and regulations aimed at combating
such practices.
    (Comment 226) One comment supports the proposed partial exemption
for fishing vessels and regards the proposed rule's interpretation of
section 204(d)(6)(C) of FSMA to be reasonable and consistent with
Congressional intent. Some comments state that although fishing vessels
that are not required to register with FDA would be fully exempt, they
ask that we adopt an exemption for food sold directly to consumers from
fishing vessels, including food sold by fishermen who are specifically
licensed to sell their own catch directly to consumers by a ``fresh
product license'' or other authority, mirroring the exemption in
proposed Sec.  1.1305(b) for farms that sell food directly to
consumers, suggesting that section 204(d)(6)(E) of FSMA gives us the
authority to exempt entities when application of the subpart S
requirements is not necessary to protect the public health.
    (Response 226) We appreciate the support for the proposed partial
exemption for fishing vessels as being consistent with Congressional
intent. We do not think the proposed modification to Sec.  1.1305(b) is
necessary. As drafted, Sec.  1.1305(b) exempts farms with respect to
food they produce that they sell directly to the consumer. Without this
exemption, farms may otherwise be required to keep various subpart S
records relating to such food, such as records relating to the
harvesting of the food. In contrast, under Sec.  1.1305(m)(1), the
owner, operator, or agent in charge of a fishing vessel is already
exempt from the subpart S requirements. An additional exemption for
this specific circumstance is therefore unnecessary. While it is true
that some owners, operators, or agents in charge of fishing vessels may
be required to keep records identifying the immediate subsequent
recipient of a food in accordance with Sec.  1.345 (see Sec.
1.1305(m)(2)), we note that Sec.  1.345 does not apply to persons who
distribute food directly to consumers (see Sec.  1.327). Therefore,
even without a modification of Sec.  1.1305(b), it is already the case
that under subpart S the owner, operator, or agent in charge of a
fishing vessel is not required to keep any records with respect to food
obtained from a fishing vessel that such person sells or donates
directly to a consumer.
    (Comment 227) Some comments state that FDA should treat wild and
farmed shellfish production the same. The comments maintain that many
individuals participate in both sectors and would be confused by the
different requirements. The comments also maintain that most dealers
also purchase both wild and farmed shellfish. One comment states that
the

rule should regulate shellfish harvesters and shellfish farmers the
same as it regulates fishing vessels (i.e., partially exempt).
    (Response 227) We note that qualifying raw bivalve molluscan
shellfish are exempt from the requirements of the final rule as
discussed in Response 200. The exemption applies to both wild-caught
and aquacultured raw bivalve molluscan shellfish.
    Regarding other shellfish, we are unable to impose the requirements
that apply to farmed shellfish on fishing vessels that harvest
shellfish because, as discussed in Response 225, Congress required us
to create a partial exemption for the owners, operators, and agents in
charge of fishing vessels (see section 204(d)(6)(C) of FSMA). And we
decline to extend this partial exemption for owners, operators, or
agents in charge of fishing vessels to farmed shellfish because, as
discussed in Response 97, we think that coverage of farms is important
to effective traceability. We acknowledge that an entity that receives
both food produced on farms and food obtained from fishing vessels will
have to identify as either an initial packer (for food produced on
farms) or first land-based receiver (for food obtained from a fishing
vessel) for the relevant transactions and comply with the applicable
recordkeeping requirements. But we note that although the requirements
for initial packer and first land-based receiver are different, the
requirements through the rest of the supply chain for food from either
type of entity are the same.
    (Comment 228) One comment asserts that there should be no new
records required for wild-caught domestic shrimp vessels as many of
these vessels already must register with FDA as food facilities and
keep one-up, one-back traceability records under subpart J.
    (Response 228) To the extent that vessels engaged in catching
shrimp are ``fishing vessels'' as defined in Sec.  1.1310, they will
not be subject to any subpart S requirements unless they are registered
food facilities, in which case they would be required to maintain
records identifying the immediate previous source and immediate
subsequent recipient of the shrimp they catch in accordance with
Sec. Sec.  1.337 and 1.345 of subpart J (see Sec.  1.1305(m), as
further explained in Response 225). If the vessel is already keeping
subpart J records, those records can be used to comply with Sec.
1.1305(m)(2). As stated in Sec.  1.1455(f), an entity does not need to
duplicate existing records that it has if they contain the information
required under subpart S.
    (Comment 229) One comment asserts that the requirements for first
receivers (under proposed Sec.  1.1330) could be read as functionally
nullifying the proposed exemption for fishing vessels. The comment
suggests that to avoid this, the rule must not require that a
traceability lot code be associated with fishing events by fishers, but
the first receiver of such food from a fisher might need to assign a
traceability lot code. The comment maintains that the GDST standards
encourage the assignment of lot codes to fishing events by fishers, but
the ISSC's implementation guidelines recognize that this might not be
possible for at least several years. Therefore, the comment suggests
that FDA encourage lot code assignment at the vessel level as a best
practice.
    (Response 229) For clarity we have changed the name of the ``first
receiver'' of food obtained from a fishing vessel to the ``first land-
based receiver,'' which we have defined to mean the person taking
possession of a food for the first time on land directly from a fishing
vessel (Sec.  1.1310). Section 1.1335 sets forth the records that a
person must keep if they are the first land-based receiver. These
requirements have been modified from what the proposed rule would have
required for first receivers of food obtained from fishing vessels, and
are limited to information that a person would reasonably be expected
to know based on information that is likely provided during the normal
course of business. The fishing vessel is not expected to provide a
traceability lot code; the traceability lot code would be assigned by
the first land-based receiver in accordance with Sec.  1.1320(a). If
the first land-based receiver is exempt, the traceability lot code
would be assigned by the first non-exempt receiver of the food in
accordance with Sec.  1.1345(b)(1) (unless that entity is an RFE or
restaurant).
    (Comment 230) Some comments ask whether the definition of fishing
vessel includes boat tenders that catch and offload fish to another
fishing vessel. Specifically, the comments ask whether the definition
includes tender vessels, carrier vessels, or mother ships. One comment
maintains that boat tenders are used in many seafood harvest situations
and are an extension of the fishing vessel that is exempt under the
proposed rule. The comment also asks FDA to clarify whether the
proposed definition of ``first receiver'' includes ``over the dock
transfers.''
    (Response 230) Any vessel that meets the definition of ``fishing
vessel'' in Sec.  1.1310 is subject to the partial exemption in Sec.
1.1305(m). In situations where a tender vessel catches fish and
offloads the fish to a carrier vessel or mother ship, all of the
vessels involved in the transaction would be partially exempt under
Sec.  1.1305(m), as long as they meet the definition of a ``fishing
vessel.'' Regarding the comment that asks us to clarify the definition
of ``first receiver'' in relation to ``over the dock transfers,'' as
discussed in Response 385, the final rule omits the proposed first
receiver requirements and includes requirements for the first land-
based receiver of food obtained from a fishing vessel. It is unclear
what ``over the dock transfer'' means in the context of the subpart S
requirements. If a transfer takes place between two fishing vessels,
then each fishing vessel would be eligible for the partial exemption in
Sec.  1.1305(m), meaning the only records they might be required to
keep would be the records described in Sec.  1.1305(m)(2), if
applicable. However, if ``over the dock transfer'' refers to a transfer
and sale from the owner, operator, or agent in charge of a fishing
vessel to a separate land-based entity, then the land-based entity
would be the first land-based receiver of the food and would have to
keep the records required under Sec.  1.1335.
15. Exemption for Transporters
    We proposed to exempt transporters of food from the proposed
traceability recordkeeping requirements (proposed Sec.  1.1305(k)). We
proposed to define a ``transporter'' as a person who has possession,
custody, or control of an article of food for the sole purpose of
transporting the food, whether by road, rail, water, or air (proposed
Sec.  1.1310).
    (Comment 231) Some comments assert that the proposal to exempt
transporters is contrary to language in section 204(d) of FSMA,
suggesting that a person who has ``possession, custody, or control'' of
food (under the proposed definition of ``transporter'') would also be a
person who ``holds'' the food under the statute. Other comments
maintain that transporters should not be exempt because although they
present a lower risk of contamination, information on when and how food
is transported is still important to have. These comments suggest that
including transporters in the rule would create added benefits and
would facilitate outbreak investigations. Some comments suggest that
the Agency should acknowledge that food may become contaminated during
transport, referencing the recordkeeping requirements already in place
under the sanitary transportation regulation (part 1, subpart O). Some
comments request that transporters be exempt from the final rule
because they believe that information from

transporters is not necessary for traceability purposes. The comments
state that transporters are subject to subpart J, so if certain foods
are exempt from this rule, transporters would still have to maintain
subpart J records for those foods. Some comments request clarification
of requirements for transporters in fish supply chains.
    (Response 231) We acknowledge that food can become contaminated
during transportation, which is why in the final rule on ``Sanitary
Transportation of Human and Animal Food'' (81 FR 20092) we established
requirements for shippers, loaders, carriers by motor vehicle and rail
vehicle, and receivers engaged in the transportation of food, including
food for animals, to use sanitary transportation practices to ensure
the safety of the food they transport. As the comments state, the
sanitary transportation regulation includes recordkeeping requirements
for certain entities subject to the regulation, though we note that
these recordkeeping requirements focus on ensuring the use of sanitary
practices during transportation, not on traceability.
    As discussed in the preamble to the proposed rule (85 FR 59984 at
59999), we believe that transporters should be exempt from the subpart
S requirements because we find that in most of our investigations of
potential foodborne illness outbreaks, it is not necessary to inspect
records maintained by food transporters because we generally are able
to obtain the tracing information we need from other persons in the
food's supply chain. Thus, the final rule maintains this exemption for
transporters of food (Sec.  1.1305(n)). Additionally, we have removed
from the final rule the proposed requirements that (1) persons who
receive listed foods keep a record of the name of the transporter who
delivered the food (proposed Sec.  1.1335(h)) and (2) persons who ship
listed foods keep a record of the name of the transporter who
transported the food from the shipper (proposed Sec.  1.1350(a)(8)), as
discussed in Section V.M of this document.
    If necessary, we could review records maintained by transporters of
the food in the usual course of business or, when applicable, in
accordance with the subpart J regulations. We note that in many cases,
the shipper or receiver will have this information as a result of the
subpart J requirements.
    Regarding the comments suggesting that the proposed exemption for
transporters is contrary to the language in the statute, the proposed
rule included several full and partial exemptions from the subpart S
requirements, including some specified by Congress and some we proposed
on our own initiative, including the exemption for transporters. It is
within our rulemaking authority to create exemptions beyond what
Congress specified. For the reasons stated above, we conclude that
exempting transporters is an appropriate exercise of our authority to
implement section 204(d) of FSMA.
16. Exemption for Nonprofit Food Establishments
    We proposed in Sec.  1.1305(l) that subpart S would not apply to
nonprofit food establishments, consistent with their exclusion from the
subpart J regulations (see Sec.  1.327(l)). We proposed to define a
nonprofit food establishment as in subpart J (Sec.  1.328 (21 CFR
1.328)), i.e., as a charitable entity that prepares or serves food
directly to the consumer or otherwise provides food or meals for
consumption by humans or animals in the United States (proposed Sec.
1.1310). The definition further stated that the term ``nonprofit food
establishment'' includes central food banks, soup kitchens, and
nonprofit food delivery services. In addition, to be considered a
nonprofit food establishment, we proposed that the establishment must
meet the terms of section 501(c)(3) of the U.S. Internal Revenue Code
(26 U.S.C. 501(c)(3)).
    Although we received comments concerned that the definition of
``nonprofit food establishment'' used for this exemption was not broad
enough, we are finalizing the exemption as proposed, for the reasons
stated below.
    (Comment 232) Some comments support the proposed exemption for
nonprofit food establishments. Some comments suggest that FDA exempt
other nonprofits aside from those that meet the terms of section
501(c)(3) of the Internal Revenue Code, such as food hubs and
businesses with section 501(c)(4), (c)(5), or (c)(6) status. The
comments maintain that numerous nonprofit food hubs and businesses are
organized under other nonprofit statuses and consequently should also
be exempt under the final rule. Some comments assert that the language
in FSMA means that the rule should only apply to facilities, and that
therefore FDA should exempt all nonprofit food establishments in which
food is prepared for or served directly to the consumer.
    (Response 232) As discussed in the preamble to the proposed rule
(85 FR 59984 at 59999), and as finalized in Sec.  1.1305(o), we are
exempting nonprofit food establishments from the rule consistent with
their exclusion from the subpart J regulation. The definition of
``nonprofit food establishment'' that we proposed and are adopting in
Sec.  1.1310 of the final rule is consistent with the definitions used
in subpart J (Sec.  1.328) and the facility registration regulation
(Sec.  1.227), both of which are limited to establishments that meet
the terms of 26 U.S.C. 501(c)(3). It is not readily apparent from the
comments which entities covered under this rulemaking have section
501(c)(4), (c)(5), or (c)(6) status. Moreover, we are not aware of any
particular challenges regarding compliance with subpart S that are
faced by entities with section 501(c)(4), (c)(5), or (c)(6) status.
Therefore, we conclude that it is not necessary to revise the
definition of nonprofit food establishment for the purposes of the
subpart S requirements.
    However, we note that the rule includes procedures for requesting a
waiver of one or more of the subpart S requirements for an individual
entity or a type of entity on the grounds that having to meet the
requirements would result in an economic hardship, due to the unique
circumstances of the individual entity or type of entity (see
Sec. Sec.  1.1405 through 1.1450, as discussed in Section V.Q of this
document). Establishments with status under a different section of
section 501(c) might wish to submit a request for a waiver if they
believe that application of the subpart S requirements to them would
result in an unusual economic hardship, and that the conditions set
forth in Sec.  1.1405 are met.
    As discussed in Response 154, we do not agree that Congress's use
of the word ``facility'' prevents subpart S from applying to entities
that provide food to consumers.
    (Comment 233) One comment requests clarification on whether
shippers who supply food to exempt nonprofits would have to follow the
requirements of the rule, maintaining that to do so would not have any
public health benefit because the nonprofit would not be required to
maintain records under the rule.
    (Response 233) The exemption for nonprofit food establishments in
Sec.  1.1305(o) applies only to the nonprofit food establishment and
not to any other entities within the supply chain that supply food to
them. We do not agree that there would be no benefit to requiring
shippers who supply food to nonprofits to maintain records, as we
continue to believe that having entities maintain records up to receipt
by the nonprofit is appropriate to help ensure the traceability of
potentially contaminated food. However, we note that the definition of
shipping in Sec.  1.1310 does not include the donation

of surplus food. Therefore, if a shipper is donating surplus food to a
nonprofit food establishment (or other entity), they would not be
required to keep records of the shipment of the donated food.
    (Comment 234) One comment requests clarification on how the
requirements would apply to participants in the ``food recovery
system,'' especially nonprofit organizations, maintaining that onerous
requirements might drive people away from participating in food
recovery efforts.
    (Response 234) If an organization participating in the ``food
recovery system'' meets the definition of ``nonprofit food
establishment'' in Sec.  1.1310 of the final rule, it would be exempt
from the rule. The comment did not provide information as to what kinds
of entities, other than nonprofit organizations, might be involved in
the food recovery system, and we are unable to determine whether there
are other entities involved in food recovery that would otherwise be
exempt from this rule. However, such entities might be eligible for
exemptions or partial exemptions under other provisions of the final
rule. Also, as discussed in Section V.Q of this document, the rule
includes procedures for requesting a waiver of one or more of the
subpart S requirements for an individual entity or a type of entity on
the grounds that having to meet the requirements would result in an
economic hardship, due to the unique circumstances of the individual
entity or type of entity (see Sec. Sec.  1.1405 through 1.1450).
17. Exemption for Persons Who Manufacture, Process, Pack, or Hold Food
for Personal Consumption
    We proposed that subpart S would not apply to persons who
manufacture, process, pack, or hold food for personal consumption
(proposed Sec.  1.1305(m)). In the preamble to the proposed rule, we
noted that whether a food is for personal consumption depends on many
factors, but we would consider food prepared in a private home and
transported for other than business purposes (e.g., to a ``potluck''
dinner with friends) to qualify for this exemption (see 85 FR 59984 at
59999, citing 69 FR 71562 at 71579). We received no comments on this
provision and we are finalizing the exemption as proposed in Sec.
1.1305(p) of the final rule.
18. Exemption for Certain Persons Who Hold Food on Behalf of Individual
Consumers
    We proposed (in Sec.  1.1305(n)) that subpart S would not apply to
persons who hold food on behalf of specific individual consumers,
provided that such persons are not parties to the transaction involving
the food they hold and are not in the business of distributing food.
The preamble to the proposed rule stated that the proposed exemption
would cover persons such as a hotel concierge, reception desk staff in
an apartment building, and staff at an office complex who receive and
store a food on the FTL on behalf of the consumer but are not parties
to the purchase of the food they hold and are not in the business of
distributing food (see 85 FR 59984 at 59999). We received no comments
on this provision and are finalizing the exemption as proposed under
Sec.  1.1305(q) of the final rule.
19. Exemption for Food for Research or Evaluation
    As discussed in the following paragraphs, we received comments that
have prompted us to add an exemption from the subpart S requirements
for food used in research or evaluation.
    (Comment 235) Some comments suggest we establish an additional
exemption for food for research and development purposes. Some
commenters request a full exemption and others note that it should be
similar in scope to the exemption for food for research and development
purposes under the FSVP regulation (see 21 CFR 1.501(c)). These
comments assert that food for research and development purposes poses a
low risk to public health, is subject to the one-up, one-back
requirements of subpart J, and is not intended for retail sale or
otherwise distributed to the public.
    (Response 235) We agree with the comments that food for research or
evaluation generally should be exempt, provided that certain conditions
similar to those in the FSVP regulation are met. We conclude that the
risk of a foodborne illness outbreak arising from use of food in
research or evaluation is low. Therefore, Sec.  1.1305(r) of the final
rule provides that subpart S does not apply to food for research or
evaluation use, provided such food (1) is not intended for retail sale
and is not sold or distributed to the public; and (2) is accompanied by
the statement ``Food for research or evaluation use.''
20. Other Requests for Exemption
    We received several comments requesting that we exempt other
persons or foods from the subpart S requirements. We discuss these
comments in the following paragraphs.
a. Certain Foods
    (Comment 236) Some comments assert that the rule is unnecessary for
tracing of seafood. Some comments maintain that there are existing
traceability requirements for certain seafood species and request that
such seafood be exempted from the rule.
    (Response 236) We do not agree that the rule is unnecessary for
tracing of seafood. Based on the data in the Model, the risk scores for
certain seafood commodities result in those foods being placed on to
the FTL and covered by the final rule. Except with respect to raw
bivalve molluscan shellfish (discussed in Section V.E.7 of this
document), we are not aware of existing traceability requirements
applicable to seafood that will ensure a comparable level of
traceability as outlined in the final rule.
    (Comment 237) One comment suggests that shrimp processors that have
gained certification through a third-party inspection should be exempt
from additional traceability requirements.
    (Response 237) We disagree with the comment. The certification to
which the comment refers generally concerns compliance with applicable
manufacturing/processing regulations, such as those concerning HACCP or
CGMP, which do not necessarily address traceability. Therefore, we do
not believe it would be appropriate to exempt shrimp processors that
obtain such certification from the subpart S requirements.
    (Comment 238) One comment suggests that a blue crab processor or
dock that holds either a Marine Stewardship Council (MSC) or Gulf
United for Lasting Fisheries-Responsible Fisheries Management
(G.U.L.F.-RFM) sustainability certification should be exempt from the
rule. The comment asserts that any processor or dock that sells
processed or live crab product using one of these certifications is
required to have undergone a chain of custody inspection and
demonstrate the capability to trace the product back to its origin. The
comment maintains that under these certifications, crab transport
crates are labeled with the fisherman's license and name, and that,
combined with trip tickets, this allows crabs to be tracked from vessel
to dealer and often to processor.
    (Response 238) The comment did not provide specific information
about the traceability aspects of these programs, and we do not have
information to establish that they have sufficient traceability
requirements to ensure the effective and efficient tracing of food
through the supply chain. However, any

existing records kept under these programs that contain information
required by subpart S can be used for compliance with the final rule.
Duplicate records would not need to be kept, which would reduce the
burden on entities with those certifications.
b. Food Hubs
    (Comment 239) Some comments request that FDA exempt food hubs from
the regulation due to the additional burden the regulation would pose
and the role that food hubs have played during the COVID-19 pandemic.
    (Response 239) We decline to establish an exemption for food hubs.
The term ``food hub'' covers a wide range of business models and
functions. Food hubs that pack and hold RACs are covered by the
``farm'' definition in the final rule if the farms that grow, harvest,
and/or raise the majority of the RACs packed and/or held by the food
hub own, or jointly own, a majority interest in the food hub. Some food
hubs may conduct activities that transform RACs into processed food.
Some food hubs have a farm-to-business/institution/retail model (e.g.,
selling to food cooperatives, grocery stores, institutional foodservice
companies, and restaurants), while others have a farm-to-consumer model
(i.e., selling directly to the consumer, such as through a CSA
program), and some are hybrids that sell to both businesses and
consumers. Some food hubs provide value added services such as fresh-
cut operations. Given the diverse range of activities conducted by food
hubs, we conclude that it is not appropriate to create a blanket
exemption for all food hubs. However, depending on the activities they
conduct, individual food hubs might meet the criteria for one or more
of the exemptions provided in the final rule.
c. Third-Party Cold Storage Facilities
    (Comment 240) Some comments request that certain facilities be
exempt from the final rule under section 204(d)(6)(E) of FSMA, which
allows FDA to provide modified requirements or an exemption from
subpart S for a food or type of facility when the Agency determines
that additional records are not necessary to protect public health.
These comments assert that we should grant exemptions for third-party
cold storage facilities where the customers, including manufacturers,
maintain ownership of the food and are responsible for the records,
provided the food continues to be owned by the entity that shipped the
food to the third-party facility. The comments assert that additional
records are not needed to protect public health in this situation and
would create a significant burden for the third-party cold storage
facilities.
    (Response 240) We decline to establish an exemption for third-party
cold storage facilities. In general, we believe it is necessary for
effective traceability to require entities that physically hold an FTL
food at a location, including third-party cold storage facilities, to
keep records to facilitate traceback and traceforward to other entities
in the food's supply chain. As discussed in Section V.F of this
document, the definition of ``holding'' in Sec.  1.1310 of the final
rule states that holding facilities could include cold storage
facilities. However, as discussed in Section V.R of this document, such
storage facilities may enter into an agreement with another party, such
as the owner of the FTL food, to keep records on behalf of the storage
facility.
d. Third-Party Logistics Providers
    (Comment 241) One comment asserts that third-party logistics
providers should not be covered by the rule because agreements between
such providers and food companies might need to be very complex, which
could lead some providers to decide not to receive or ship FTL foods.
The comment maintains that this could hurt small businesses who rely on
third-party logistics providers to grow their businesses.
    (Response 241) We decline to establish an exemption for third-party
logistics providers. Regardless of agreements in place between third-
party logistics providers and food companies, if the third-party
logistics provider is an entity that manufactures, processes, packs, or
holds a food on the FTL, subpart S records are needed to ensure
traceability is maintained and unbroken between supply chain partners.
As discussed in Response 259, persons who do not physically possess
food are not engaged in ``holding'' within the meaning of this final
rule. Thus, if a third-party logistics provider does not take physical
possession of the food, it would not be subject to the rule.
e. Small Wholesalers
    (Comment 242) Some comments ask whether there is an exemption for
very small wholesalers. The comments note that while there is an
exemption for small retailers, there is no mention of wholesalers. The
comments ask that if small and very small wholesale operations are
covered by the rule, FDA should provide further guidance as to how
these firms can comply in a way that aligns with their fiscal
limitations.
    (Response 242) While we understand the concerns of small
wholesalers about the potential financial impact of compliance with the
rule, we also recognize that it is necessary to ensure that essential
traceability information is kept and passed forward along the entire
supply chain. We conclude that if small wholesalers were exempt from
the rule, there might be significant gaps in the tracing information
available at critical points throughout the distribution chain. Small
RFEs and restaurants are at the end of the distribution chain, while
small producers are typically at the beginning of the distribution
chain, which means that the exemptions in Sec.  1.1305(a) and (i) do
not create gaps in the distribution chain. An exemption for small
wholesalers, however, would create a gap in the middle of the
distribution chain. Therefore, we decline to adopt a full exemption for
small wholesalers (or for any small entities not at either end of the
supply chain). However, as discussed in Response 470, the final rule
provides some relief to small wholesalers and other small entities in
the middle of the supply chain by exempting them from the requirement
to provide an electronic sortable spreadsheet containing requested
tracing information under certain circumstances.
    As previously stated, in accordance with section 204(h) of FSMA, we
will be issuing an SECG specifically aimed at assisting affected small
businesses in complying with the requirements of this rule. In
addition, we may issue other materials to help smaller entities and all
persons subject to the FTL recordkeeping requirements understand and
meet the requirements applicable to them.
f. Intracompany Shipments
    (Comment 243) Some comments suggest that intracompany shipments
should be exempt from the rule, maintaining that keeping records of
such shipments is not necessary to protect public health and would
create a significant burden. Some comments suggest that FDA revise the
definitions of ``shipping'' and ``receiving'' to expressly exclude
shipments between shippers and receivers that are under the ownership
or operational control of a single company. These comments maintain
that data related to internal movement of food products between
locations under the same ownership would fail to add value, cause
delays in providing critical traceability information to FDA, and be
overly burdensome. Noting that we proposed to define ``receiving'' as
an event in a

food's supply chain in which a food is received by a customer (other
than a consumer) at a defined location after being transported from
another defined location, the comments assert that intracompany
movements do not involve a ``customer'' because the typical industry
understanding of ``customer'' means the purchaser of the food. The
comments also maintain that companies already have appropriate internal
controls and recordkeeping requirements in place for traceability of
food that moves within a company. In addition, the comments assert that
each CTE will trigger voluminous records and that exempting
intracompany movement of FTL foods will significantly reduce the burden
of the rule.
    (Response 243) We decline to exempt intracompany shipments from the
subpart S requirements. We conclude that effective traceability
requires that records be kept when a product changes physical location,
regardless of whether the shipper and receiver are under the ownership
or operational control of the same company as in intracompany shipment
(as the comments have described that term). Therefore, as discussed
more fully in Section V.F of this document, we have revised the
definition of ``shipping'' to specify that it includes sending an
intracompany shipment of food from one location at a particular street
address of a firm to another location at a different street address of
the firm; we have added a similar clarification to the definition of
``receiving.'' However, we note that movement of a product within a
particular location of a firm (i.e., at a particular street address)
does not constitute ``shipping'' or ``receiving'' under the final rule.
g. Cross-Docking
    (Comment 244) Some comments suggest that we provide an exemption
for cross-docking activities and describe cross-docking as when a
pallet of food products is sent from a firm through a distribution
center or cross-docker and then sent on to the next point in the supply
chain. The comments maintain that during cross-docking, a product
passes over a loading dock from one transporter to another without
being held at the cross-docking facility for an appreciable amount of
time, and the product is held under procedures that maintain essential
transportation conditions, such as temperature. The comments maintain
that the food is not entered into the inventory of the distribution
center or cross-docker, and that the shipping records for such food are
primarily paper invoices. The comments assert that shipping and
receiving requirements should not apply to food that is shipped in this
way and request clarity regarding the common logistical practice of
``cross-docking'' and whether it is covered under subpart S.
    (Response 244) We do not think it is necessary to exempt cross-
docking activities from the subpart S requirements. The final rule
defines shipping to mean an event in a food's supply chain in which a
food is arranged for transport (e.g., by truck or ship) from one
location to another location. Records must be kept regarding both
locations, i.e., the location where the shipping event began and the
location where it ended (i.e., where the food was received). It is not
necessary to have records of the route the food took, including any
instances where it may have been moved from one carrier to another.
Thus, in a cross-docking situation where food is arranged for transport
from point A to point B, but it is briefly placed on a loading dock at
point X in order to be transferred from one truck to another truck, we
would not consider the food to have been shipped to point X (or to have
been received at point X). Thus, no records would need to be kept
regarding point X; the required shipping and receiving records would
reflect that the food was shipped from point A and received at point B.
A full discussion of the requirements applicable to the shipping (under
Sec.  1.1340) and receiving (under Sec.  1.1345) of FTL foods is set
forth in Sections V.M and V.N, respectively, of this document.
    We recognize that questions might arise in situations where food is
arranged for transport from point A to point B, with an understanding
that there will be an intermediary step during which the food is held
at point X for a period of time. To determine whether the food was
received at point X (and then subsequently shipped to point B), we
would consider factors such as how long the food was held at point X,
whether it was held there under temperature-controlled conditions that
differ from transportation conditions, and whether it was taken into
inventory at point X.

F. Definitions (Sec.  1.1310)

    We proposed to codify definitions of several terms we use in the
subpart S traceability recordkeeping regulation (proposed Sec.
1.1310). As discussed in the following paragraphs, we have revised
several of the proposed definitions in response to comments we
received, and we have added and deleted definitions in accordance with
other changes to the proposed requirements we are making in the final
rule.
    (Comment 245) Several comments request that we ensure that
definitions of terms used in the subpart S are consistent with the
definitions of those terms in other FSMA regulations.
    (Response 245) We agree that the definitions should be aligned as
much as possible. In most cases, the definitions used in the final rule
are identical to the definitions in other FDA regulations, including
other FSMA regulations. To the extent there are minor differences in
certain definitions, we discuss them in response to the comments below.
1. Category
    We proposed to define ``category'' to mean a code or term used to
classify a food product in accordance with a recognized industry or
regulatory classification scheme, or a classification scheme a person
develops for their own use. We did not receive any comments on the
definition of ``category.'' The term ``category'' is not included in
the final rule as it was a component of the definition of
``traceability product description,'' which we have also deleted (see
Response 299 regarding deletion of the term ``traceability product
description'').
2. Commingled Raw Agricultural Commodity
    Although the proposed rule included a definition of ``commingled
raw agricultural commodity'' within the text of the partial exemption
for commingled RACs (proposed Sec.  1.1305(f)), we have revised the
definition and moved it to the definitions section of the final rule
(Sec.  1.1310). In accordance with section 204(d)(6)(D) of FSMA, we
proposed to define ``commingled raw agricultural commodity'' as any
commodity that is combined or mixed after harvesting but before
processing, except that the term ``commingled raw agricultural
commodity'' does not include types of fruits and vegetables that are
RACs to which the standards for the growing, harvesting, packing, and
holding of produce for human consumption in part 112 apply. We further
stated that for the purpose of this definition, a commodity is
``combined or mixed'' only when the combination or mixing involves food
from different farms; in addition, the term ``processing'' would mean
operations that alter the general state of the commodity, such as
canning, cooking, freezing, dehydration, milling, grinding,
pasteurization, or homogenization.
    As discussed in Response 206, we have revised the definition of

``commingled raw agricultural commodity'' to specify that a commodity
is ``combined or mixed'' only when the combination or mixing involves
food from different farms under different company management,
consistent with the statement in the preamble to the proposed rule that
we would not consider packed eggs that are from a single farm or
separate farms under the same management to be commingled shell eggs
(see 85 FR 59984 at 59997). In addition, as discussed in Response 208,
we have revised the definition of ``commingled raw agricultural
commodity'' to specify that, for food obtained from a fishing vessel, a
commodity is ``combined or mixed'' only when the combination or mixing
involves food from different landing vessels and occurs after the
vessels have landed. We are finalizing the remainder of the definition
of ``commingled raw agricultural commodity'' as proposed.
3. Cooling
    We proposed to define ``cooling'' to mean active temperature
reduction of a food using hydrocooling, icing, forced air cooling,
vacuum cooling, or a similar process, either before or after packing.
We have modified the definition of ``cooling'' for clarity as explained
below.
    (Comment 246) One comment asks FDA to confirm that re-cooling is
considered part of cooling under the rule.
    (Response 246) We recognize that cooling of food can take place at
multiple points along the supply chain. To more precisely specify the
entities required (under Sec.  1.1325 of the final rule) to keep
certain records of cooling that occurs before a RAC is initially
packed, we have revised the definition to refer to active temperature
reduction of a RAC, rather than a ``food.'' Under this revised
definition, re-cooling would be considered ``cooling'' if the food in
question was still a RAC, and if the other elements of the definition
were met. In addition, we have clarified that ``cooling'' does not
include icing of seafood, because seafood is generally iced to maintain
product quality during holding rather than to reduce the temperature of
the food.
4. Creating
    We proposed to define ``creating'' to mean making or producing a
food on the FTL (e.g., through manufacturing or processing) using only
ingredient(s) that are not on the FTL. The definition further stated
that ``creating'' does not include originating or transforming a food.
As explained below, we have removed this term from the final rule.
    (Comment 247) As part of requests for FDA to align the final rule
with industry traceability standards, some comments request that the
Agency use the International Organization for Standardization (ISO)/
International Electrotechnical Commission (IEC) 19987 and 19988
standard term of ``commissioning'' instead of the proposed ``growing''
and ``creating'' terms. Other comments assert that the terms
``creating'' and ``transforming'' are confusing, as they are
essentially the same thing.
    (Response 247) We agree that the term ``creating'' appears to have
caused some confusion, based on comments. In the final rule, we have
removed the term ``creating'' and merged the concept and definition of
``creating'' with the concept and definition of ``transformation.''
Thus, the final rule defines ``transformation'' in part as an event in
a food's supply chain that involves manufacturing/processing a food or
changing a food (e.g., by commingling, repacking, or relabeling) or its
packaging or packing, when the output is a food on the FTL. This
definition encompasses both ``transformation'' and ``creating'' as
those terms were defined in the proposed rule. While we appreciate the
value of industry standards for traceability, we decline to use the
term ``commissioning'' in the final rule, as we believe it is not
needed. We believe that the concept of ``transformation'' as defined in
the final rule is widely used in industry and, because it streamlines
two concepts into one, should reduce potential confusion. We also do
not believe it would be appropriate to combine the ``growing'' activity
(there was no proposed definition of ``growing'') into the
``transformation'' definition because we conclude it is more consistent
with the framework of the FTL traceability rule to focus the concept of
``transformation'' primarily on manufacturing/processing and related
activities.
5. Critical Tracking Event
    We proposed to define ``critical tracking event'' to mean an event
in the supply chain of a food involving the growing, receiving
(including receipt by a first receiver), transforming, creating, or
shipping of the food. We did not receive any comments on the definition
of ``critical tracking event.'' In the final rule, we have modified the
definition of ``critical tracking event'' to align with other changes
to the proposed codified provisions. In response to comments, the CTEs
in the final rule consist of harvesting, cooling (before initial
packing), initial packing of RACs other than food obtained from a
fishing vessel, first land-based receiving of food obtained from a
fishing vessel, shipping, receiving, and transformation (see Sections
V.H through V.O of this document for a discussion of changes to the
CTEs). As a result of these changes, we define ``critical tracking
event'' in the final rule as an event in the supply chain of a food
involving the harvesting, cooling (before initial packing), initial
packing of a RAC other than a food obtained from a fishing vessel,
first land-based receiving of a food obtained from a fishing vessel,
shipping, receiving, or transformation of the food.
6. Farm
    We proposed to define ``farm'' as it is defined in Sec.  1.328. The
definition further stated that, for producers of shell eggs, ``farm''
means all poultry houses and grounds immediately surrounding the
poultry houses covered under a single biosecurity program, as set forth
in Sec.  118.3. We have retained this definition in the final rule.
    (Comment 248) One comment asks whether oyster leaseholders are
considered farms.
    (Response 248) The definition of ``farm'' in Sec.  1.328 states
that, among other things, a farm is an operation under one management
in one general (but not necessarily contiguous) physical location
devoted to the growing of crops, the harvesting of crops, the raising
of animals (including seafood), or any combination of these activities.
Therefore, if an oyster leasehold is used for the raising of seafood,
it is a farm for the purposes of this rule.
    (Comment 249) One comment requests that FDA clearly state that
aquaculture operations are farms, and asks that we require that growing
area coordinates or the equivalent be maintained for aquaculture farms,
not just harvest information.
    (Response 249) As discussed above, operations devoted to the
raising of seafood, such as aquaculture operations, are farms. As
discussed in Response 328, the final rule requires that aquaculture
farms maintain a farm map showing the areas in which they raise FTL
foods, and the map must show the location and name of each container
(e.g., pond, pool, tank, cage) in which the seafood is raised,
including geographic coordinates and any other information needed to
identify the location of each container (see Sec.  1.1315(a)(5) and
(a)(5)(ii)). As discussed in Section V.J of this document, persons who
harvest an aquacultured food are required to keep (among other KDEs)
information

identifying where the food was harvested (see Sec.  1.1325(a)(1)(vi)).
Similarly, as discussed in Section V.K of this document, persons who
initially pack an aquacultured food must also keep this information
(see Sec.  1.1330(a)(6)).
    (Comment 250) Several comments request that we update the
definition of ``farm'' in this rulemaking or update it elsewhere before
finalizing the rule. These comments suggest that there is a need for a
revised and clear definition of ``farm'' that is consistent across all
the FSMA rulemakings. One comment maintains that the question of how to
handle intracompany shipments is complicated by the fact that the
definition of farm in Sec.  1.328 does not clearly define whether an
operation is one farm or multiple farms.
    (Response 250) We agree that, to the extent possible, the
definition of ``farm'' in the subpart S food traceability regulation
should be consistent with other FDA regulations, including other FSMA
rules. The final rule defines ``farm'' to mean farm as defined in Sec.
1.328, except that for producers of shell eggs, ``farm'' means all
poultry houses and grounds immediately surrounding the poultry houses
covered under a single biosecurity program, as set forth in Sec.
118.3. By referencing the farm definition in Sec.  1.328, we are
aligning our definition not only with subpart J (which is where Sec.
1.328 appears), but also with several regulations that have adopted the
identical farm definition, including the food facility registration
regulation (see Sec.  1.227), the produce safety regulation (see Sec.
112.3), and the preventive controls for human food regulation (see 21
CFR 117.3). We think it is appropriate for the farm definition in the
food traceability regulation to include additional language about egg
farms so that our rule is also aligned with the definition of ``farm''
in the egg safety regulation (see Sec.  118.3).
    As discussed in the January 2018 document, ``Guidance for Industry:
Policy Regarding Certain Entities Subject to the Current Good
Manufacturing Practice and Preventive Controls, Produce Safety, and/or
Foreign Supplier Verification Programs,'' FDA intends to initiate a
future rulemaking related to farm activities, which may change the farm
definition that is used in those three FSMA regulations (which is
identical to the farm definition used in this final rule). If the
definition of ``farm'' in Sec.  1.328 is revised through that separate
rulemaking, those revisions will be incorporated into the subpart S
food traceability regulation, because our definition of ``farm''
directly references Sec.  1.328.
7. First Land-Based Receiver
    We are adding a definition of ``first land-based receiver'' to the
final rule to clarify the scope of changes we have made concerning
recordkeeping requirements for the first land-based receiver of food
obtained from a fishing vessel (see Section V.L of this document). For
the purposes of subpart S, ``first land-based receiver'' means the
person taking possession of a food for the first time on land directly
from a fishing vessel.
8. First Receiver
    We proposed to define ``first receiver'' as the first person (other
than a farm) who purchases and takes physical possession of a food on
the FTL that has been grown, raised, caught, or (in the case of a non-
produce commodity) harvested. Because we have deleted from the rule the
proposed requirements applicable to the first receiver of an FTL food
(see Section V.K of this document), we are also deleting the definition
for ``first receiver.''
    (Comment 251) One comment asks that we include a definition of a
``first shipper'' to allow the first receiver to know what data must be
sent with each shipment.
    (Response 251) Because we have deleted the proposed requirements
that would have applied to first receivers, there is no need to define
``first shipper.''
    (Comment 252) One comment asks that the first receiver definition
be amended to include fresh produce packinghouses because they maintain
many of the first receiver KDEs linked to a lot code assigned by the
packinghouse at the time of packing. The comment contends that growers
are comfortable with packers maintaining this information on their
behalf.
    (Response 252) As previously stated, the final rule deletes the
proposed requirements for first receivers, so there is no need to
revise the definition as suggested. However, in response to comments,
we have replaced the requirements for first receivers with requirements
for persons who either (1) perform the initial packing of a RAC other
than a food obtained from a fishing vessel or (2) are the first land-
based receiver of a food obtained from a fishing vessel (see Sections
V.J and V.K of this document). As discussed below, ``initial packing''
is defined as packing a RAC (other than a food obtained from a fishing
vessel) for the first time. Under Sec.  1.1330 of the final rule, an
entity (such as a produce packinghouse) that initially packs a RAC not
obtained from a fishing vessel must assign a traceability lot code and
maintain harvest and (when applicable) cooling KDEs, among others,
linked to the traceability lot code.
    (Comment 253) One comment requests that we clarify situations when
an RFE might meet the definition of a ``first receiver,'' such as when
an RFE purchases from a vendor that received food from a farm.
    (Response 253) As previously stated, we have deleted the proposed
requirements for first receivers of FTL foods. We have replaced the
first receiver concept with the concepts of initial packing (for RACs
not obtained from a fishing vessel) and first land-based receiving (for
food obtained from a fishing vessel). We think it is unlikely that an
RFE or restaurant would engage in the initial packing of a food. We
also do not think that most RFEs or restaurants would be the first
land-based receiver of a food obtained from a fishing vessel, although
there are situations where this might be the case. In most
circumstances we anticipate that the only CTE performed by an RFE or
restaurant would be receiving.
    (Comment 254) One comment expresses concern that the inclusion of
ownership in the proposed definition of ``first receiver'' would create
confusion with FDA's definition of ``secondary activities farm'' in the
produce safety regulation.
    (Response 254) Because the final rule does not include requirements
for first receivers, this should eliminate any possible confusion of
the term ``first receiver'' with definitions of terms in other
regulations. We also note that the definitions of ``initial packing''
and ``first land-based receiver'' (which define the events that
replaced the first receiver CTE) do not include ownership of the food
as part of the definition.
    (Comment 255) One comment requests that FDA define ``non-farm
entity,'' which is a phrase we used in the preamble to the proposed
rule to explain the proposed definition of ``first receiver.''
    (Response 255) Because the final rule does not include requirements
for ``first receivers,'' there is no need to clarify the meaning of
``non-farm entity.''
9. Fishing Vessel
    We proposed to define ``fishing vessel'' as any vessel, boat, ship,
or other craft which is used for, equipped to be used for, or of a type
which is normally used for fishing or aiding or assisting one or more
vessels at sea in the performance of any activity relating to fishing,
including, but not limited to,

preparation, supply, storage, refrigeration, transportation, or
processing. On our own initiative, we have added text at the end of the
definition stating that the definition is as set forth in the Magnuson-
Stevens Fishery Conservation and Management Act, 16 U.S.C. 1802(18),
which is the definition for ``fishing vessel'' specified in section
204(d)(6)(C) of FSMA.
    (Comment 256) One comment requests that we revise the definition of
``fishing vessel'' to include aquaculture farm vessels or trucks,
because shellfish farms do not use boats to access their farms. The
comment maintains that the Magnuson-Stevens Act definition of ``fishing
vessel'' does not apply to aquaculture.
    (Response 256) We decline to make this change. Section 204(d)(6)(C)
of FSMA requires a partial exemption for ``fishing vessel'' as that
term is defined in section 3(18) of the Magnuson-Stevens Fishery
Conservation and Management Act. If a conveyance used on an aquaculture
farm does not meet this definition, it would not be considered a
``fishing vessel'' for the purposes of subpart S.
10. Food Traceability List
    We proposed to define ``Food Traceability List'' to mean the list
of foods for which additional traceability records are required to be
maintained, as designated in accordance with section 204(d)(2) of FSMA.
The definition further stated that the term ``Food Traceability List''
includes both the foods specifically listed and foods that contain
specifically listed foods as ingredients. We did not receive any
comments on the proposed definition, but we received several comments
asking whether certain foods were on the FTL, some of which indicated
confusion with how the FTL was defined. We are revising the definition
in the final rule for clarity, consistent with determinations we have
made regarding the description of foods on the FTL (see Response 27).
Therefore, the final rule defines ``Food Traceability List'' as the
list of foods for which additional traceability records are required to
be maintained, as designated in accordance with section 204(d)(2) of
FSMA, and further states that the term ``Food Traceability List''
includes both the foods specifically listed and foods that contain
listed foods as ingredients, provided that the listed food that is used
as an ingredient remains in the same form (e.g., fresh) in which it
appears on the list.
11. Growing Area Coordinates
    We proposed to define ``growing area coordinates'' as the
geographical coordinates (under the global positioning system (GPS) or
latitude/longitude) for the entry point of the physical location where
the food was grown and harvested.
    (Comment 257) One comment requests that the final rule emphasize
that the term ``growing area coordinates'' applies to where a food was
both grown and harvested.
    (Response 257) Because growing area coordinates was one of the KDEs
we proposed to require for the CTE of growing an FTL food, and the
final rule deletes the proposed CTE for growing of foods (see Section
V.J of this document), we are also deleting the definition of ``growing
area coordinates.'' As discussed in Section V.G of this document, the
final rule instead requires certain farms to keep, as part of their
traceability plan, a farm map showing the location and name of each
field (or other growing area) in which an FTL food is grown, including
geographic coordinates and any other information needed to identify the
location of each field or growing area. As discussed in Section V.J of
this document, harvesters of produce covered by the rule also will be
required to keep, among other KDEs, the name of the field or growing
area from which the food was harvested (which must correspond to the
name used by the grower), or other information identifying the harvest
location at least as precisely as the field or other growing area name.
Similar requirements apply to aquacultured food, as discussed in
Section V.J.
12. Harvesting
    We proposed to define ``harvesting'' to mean activities of farms
and farm mixed-type facilities that are traditionally performed on
farms for the purpose of removing RACs from the place they were grown
or raised and preparing them for use as food. The definition further
stated that ``harvesting'' is limited to activities performed on RACs,
or on processed foods created by drying/dehydrating a RAC without
additional manufacturing/processing, on a farm. The proposed definition
went on to state that ``harvesting'' does not include activities that
transform a RAC into a processed food as defined in section 201(gg) of
the FD&C Act, and provided examples of harvesting, including cutting
(or otherwise separating) the edible portion of the RAC from the crop
plant and removing or trimming part of the RAC (e.g., foliage, husks,
roots, or stems). Additional examples of harvesting in the proposed
definition included collecting eggs, taking of fish and other seafood
in aquaculture operations, milking, field coring, filtering, gathering,
hulling, shelling, sifting, threshing, trimming of outer leaves of, and
washing RACs grown on a farm.
    (Comment 258) Several comments state that the proposed definition
of ``harvesting'' does not include ``cooling,'' unlike the definition
of ``harvesting'' in other FSMA regulations. The comments ask that we
include ``cooling'' in the definition of ``harvesting'' to make the
definition consistent with the other FSMA regulations.
    (Response 258) We agree that it is important to maintain
consistency in definitions, when possible, in situations where the same
term is defined in multiple FDA regulations. Because of this, we have
aligned many of the subpart S definitions with Sec.  1.227, which is a
provision with which many other FSMA rules have also aligned their
definitions. We are therefore revising the definition of ``harvesting''
in the final rule so that it is the same as the definition in Sec.
1.227. We had proposed not to include ``cooling'' in the definition
because the rule includes KDEs related to cooling and we believed it
would be helpful to distinguish cooling from harvesting. However, to
maintain consistency across FDA regulations, the final rule includes
cooling in ``harvesting,'' while maintaining separate KDEs for the two
different events of harvesting and cooling. As discussed above, the
final rule continues to include a definition of ``cooling,'' to clarify
the application of the KDEs that relate to cooling. When a person
performs ``cooling'' as defined in the final rule and that person does
not otherwise perform any activities associated with harvesting, they
would not be required to maintain the harvesting KDEs in Sec.
1.1325(a). If applicable, such a person would be required to maintain
the cooling KDEs in Sec.  1.1325(b).
    In accordance with finalizing the definition of ``harvesting'' as
it appears in Sec.  1.227, we are removing from the proposed definition
a few of the additional examples of harvesting that we had proposed to
include, specifically ``collecting eggs, taking of fish and other
seafood in aquaculture operations, [and] milking.'' We continue to
consider these activities to be harvesting activities, even though we
are removing them from the definition for the sake of consistency.
Other than the removal of these additional examples and the

addition of ``cooling'' to the list of additional examples, the
remainder of the proposed definition of ``harvesting'' was already
identical to the definition in Sec.  1.227.
13. Holding
    We proposed to define ``holding'' to mean storage of food and also
include activities performed incidental to storage of a food (e.g.,
activities performed for the safe or effective storage of that food,
such as fumigating food during storage, and drying/dehydrating RACs
when the drying/dehydrating does not create a distinct commodity (such
as drying/dehydrating hay or alfalfa)). The definition further stated
that ``holding'' also includes activities performed as a practical
necessity for the distribution of that food (such as blending of the
same RAC and breaking down pallets) but does not include activities
that transform a RAC into a processed food as defined in section
201(gg) of the FD&C Act. The proposed definition notes that holding
facilities include warehouses, cold storage facilities, storage silos,
grain elevators, and liquid storage tanks.
    (Comment 259) One comment asks that we confirm that the definition
of ``holding'' requires physical possession of food and expresses
support for that definition.
    (Response 259) We confirm that the definition of ``holding''
requires physical possession of the food. However, to ensure that
``holding'' is defined consistently in FDA regulations, we are not
adding this clarification to the text of the definition. The final rule
maintains the same definition of ``holding'' that we proposed with one
edit (explained below), which makes the definition in the final rule
identical to that in Sec.  1.227 and consistent with other FDA
regulations, including the FSMA regulations.
    (Comment 260) Some comments assert that the ``exemption'' of
brokers and importers who do not physically possess FTL foods will
complicate successful implementation of the rule. The comments do not
believe that most importers also hold food, and they maintain that, in
FSMA's FSVP provisions, Congress recognized the need to hold importers
accountable for the safety of the foods they import, regardless of
whether they take physical possession of the food. The comments
maintain that importers should retain and share with key partners
essential traceability data to enable FDA to access the lot number and
necessary information at the point of sale. The comments also state
that, in the sanitary transportation regulation, freight brokers are
identified as a type of ``shipper'' that is subject to that regulation.
The comments assert that because other FSMA regulations recognize the
role that importers and brokers play in food safety, importers and
brokers should not be excluded from the subpart S requirements.
    A few comments urge FDA to ensure that brokers and importers help
facilitate compliance for other entities in the supply chain. The
comments acknowledge that brokers may not hold the food and therefore
would not be covered by the rule, but the comments maintain that such
brokers may still possess relevant information for traceability. The
comments also question whether excluding such brokers from the rule
would place an unfair burden on manufacturers to ensure that
information is shared across the supply chain if the broker is the
entity that moves the food.
    (Response 260) Section 204(d)(1) of FSMA directs FDA to establish
recordkeeping requirements for facilities that manufacture, process,
pack, or hold foods for which we have determined that the additional
requirements are appropriate and necessary to protect the public
health. As discussed in the preamble to the proposed rule (85 FR 59984
at 60000), we believe that persons who do not physically possess food
are not engaged in holding of food within the meaning of the rule. This
means, for example, that a person who coordinates the import of a FTL
food but never takes physical possession of the food would not be
subject to the rule, while a person who imports a listed food and
physically possesses the food would be subject to the rule unless an
exemption applies. Similarly, food brokers who negotiate sales of food
from producers to wholesalers, retail stores, and others but never
physically possess the food would not be subject to the rule. Although,
as noted by the comments, brokers and importers that do not physically
possess food are subject to other FSMA regulations, the inapplicability
of the subpart S requirements to such firms does not constitute a
conflict, as the different regulations serve different food safety
purposes and are based on different statutory authorities. Given the
many different business models and persons that may be involved within
a supply chain, we encourage all supply chain partners to work together
to provide the required information to each other to ensure end-to-end
traceability.
    We also note that entities that are covered by the rule may
designate entities that are not covered, such as importers or brokers
who do not hold the food, to maintain traceability records on behalf of
the covered entity (see Sec.  1.1455(b)). However, the covered entity
would remain responsible for ensuring that the subpart S requirements
are met for the FTL foods that they manufacture, process, pack, or
hold.
    (Comment 261) One comment notes that the proposed definition of
``holding'' omits the word ``could'' from the statement in the
definition of ``holding'' in the preventive controls regulation that
``[h]olding facilities could include warehouses, cold storage
facilities, storage silos, grain elevators, and liquid storage tanks.''
The comment asks if the omission was intended to convey a different
meaning.
    (Response 261) We did not intend to convey a different meaning of
``holding'' from that in the preventive controls regulation. To ensure
that we are defining ``holding'' consistently, the final rule specifies
that holding facilities ``could include'' warehouses, cold storage
facilities, storage silos, grain elevators, and liquid storage tanks.
    (Comment 262) One comment requests that we replace the example of
``drying/dehydrating hay or alfalfa'' in the definition of ``holding''
with an example that is relevant to the current list of FTL foods.
    (Response 262) We disagree with the comment that we should delete
the example of drying/dehydrating hay or alfalfa from the definition of
``holding'' in the final rule. As noted above, we believe it is
important to maintain consistency with definitions that are common
across various FDA regulations (including the FSMA regulations);
therefore, we are finalizing the definition of ``holding'' as it
appears in Sec.  1.227.
    (Comment 263) One comment asks whether the definition of holding
includes holding of live animals, such as lobsters in a lobster pond.
    (Response 263) Crustaceans such as lobsters are included on the FTL
and are therefore covered by the final rule. Because ``holding'' means
storage of food, including activities performed incidental to storage
of a food, holding crustaceans such as lobsters in ponds or other
containers is ``holding'' under the final rule.
    (Comment 264) One comment requests that we clarify the difference
between drying alfalfa and drying raisins, and asks why drying alfalfa
is considered a harvesting activity while drying raisins is considered
a manufacturing/processing activity.
    (Response 264) We regard the drying of hay and alfalfa as a holding
activity (rather than a ``harvesting'' activity as

the comment asserts) because the drying is done to effectuate the safe
storage of hay/alfalfa and is not a process that transforms the hay/
alfalfa into a distinct commodity. The drying of grapes into raisins is
considered a manufacturing/processing activity because the process
transforms the grapes (a RAC) into a distinct commodity (raisins),
which is not a RAC.
14. Initial Packing
    We are adding a definition of ``initial packing'' to clarify the
scope of the CTE for the initial packing of a food, as discussed in
Section V.K of this document. The final rule defines ``initial
packing'' to mean packing a RAC (other than a food obtained from a
fishing vessel) for the first time.
15. Key Data Element
    We proposed to define ``key data element'' to mean information
associated with a CTE for which a record must be established and
maintained in accordance with this subpart. We did not receive any
comments on this definition. On our own initiative, we are revising the
definition to specify that a KDE is information associated with a CTE
for which a record must be maintained ``and/or provided'' in accordance
with subpart S, to reflect that certain KDEs must be provided to other
supply chain entities as well as maintained. Also on our own
initiative, we removed ``established and'' in the phrase ``for which a
record must be established and maintained in accordance with this
subpart,'' because in some situations an entity might receive the
relevant record from a supply chain partner (e.g., the shipper), rather
than establish a new record.
16. Kill Step
    We proposed to define ``kill step'' to mean processing that
significantly minimizes pathogens in a food. We did not receive any
comments on this definition, but we received questions about what
constitutes a kill step, some of which indicated confusion about how to
apply the definition. As discussed in Section V.B of this document, we
have added the word ``lethality'' before ``processing'' in the
definition to clarify that the processing must be robust and not
something that simply reduces pathogens (e.g., a washing process).
17. Location Description
    We proposed to define ``location description'' to mean a complete
physical address and other key contact information, specifically the
business name, physical location name, primary phone number, physical
location street address (or geographical coordinates), city, state, and
zip code for domestic facilities and comparable information for foreign
facilities, including country; except that for fishing vessels,
``location description'' means the name of the fishing vessel that
caught the seafood, the country in which the fishing vessel's license
(if any) was issued, and a point of contact for the fishing vessel.
    (Comment 265) Several comments state that requiring both a
``physical location name'' and a ``physical location description'' is
confusing. The comments maintain that a physical location description
typically means a complete physical address and other key contact
information; another comment states that ``location description''
should be defined as the business name, phone number, and physical
address. Some comments request that we clarify which KDEs are required
for a location description; several other comments suggest that we
allow flexibility in how an entity's location is communicated.
    (Response 265) We agree that the proposed definition of ``location
description'' was somewhat unclear. To address this, we have deleted
``physical location name'' from the definition and removed the word
``primary'' preceding ``phone number'' as it was not adding clarity. We
also removed the phrase ``complete physical address'' from the
beginning of the definition because it was redundant with the
information that followed. The revised definition also specifies that
the key contact information should be for the location where a food is
handled (as opposed to the address of the corporate headquarters of a
brand owner or parent company), because that is the information that is
most useful during a traceback investigation. The final rule therefore
defines ``location description'' to mean key contact information for
the location where a food is handled, specifically the business name,
phone number, physical location address (or geographic coordinates),
and city, state, and zip code for domestic locations and comparable
information for foreign locations, including country.
    We are providing flexibility in allowing a physical location
address or geographic coordinates. However, there is only so much
flexibility we can allow in the location description because it is
important for the location description to be a complete set of
information to allow us to quickly identify, during an outbreak of
foodborne illness, the physical location of the entity that handled the
FTL food, as well as to have an accurate phone number that will allow
us to contact that location quickly.
    (Comment 266) One comment maintains that, for fishing vessels,
location description is not a KDE used by other traceability programs
and should be changed to vessel flag state. Another comment says that
location description is a confusing term with respect to fishing
vessels because it could include the vessel identification number,
license number, name of vessel, and country in which the vessel is
licensed. The comment also asks why a point of contact is needed and
suggests that this KDE be optional for fishing vessels.
    (Response 266) The final rule omits from the definition of
``location description'' the proposed text on what the definition meant
specifically for fishing vessels. Instead, Sec.  1.1335 of the final
rule specifies that if a person is the first land-based receiver of a
food that was obtained from a fishing vessel, the only location
description record the person must maintain is the location description
for itself, which also serves as the traceability lot code source for
the food, since the first land-based receiver must assign a
traceability lot code to the food (see Section V.H of this document).
We have removed requirements to maintain records related to the
identity of the fishing vessel, such as the country of license of the
vessel and a point of contact for the vessel (which we had proposed as
part of the location description) and the vessel identification number
(which we had proposed as part of the location identifier), to simplify
the requirements of the final rule, as we have determined that this
information is not essential for traceability under subpart S. However,
the first land-based receiver of a food obtained from a fishing vessel
must maintain a record of the harvest date range and location for the
trip during which the food was harvested because it may be important to
know where the fish was caught for traceability purposes in the event
of an outbreak of foodborne illness.
18. Location Identifier
    We proposed to define ``location identifier'' to mean a unique
identification code that an entity assigns to the physical location
name identified in the corresponding location description, except that
for fishing vessels, location identifier would mean the vessel
identification number or license number (both if available) for the
fishing vessel. To avoid potential confusion regarding this term, we
have deleted it from the rule, as discussed in response to the comments
below.

    (Comment 267) Several comments maintain that including both a
location description and location identifier for an entity is redundant
and that use of the term ``identifier'' is confusing, offers more
detail than is necessary, and could be difficult to obtain, while other
comments suggest that either location description or location
identifier but not both should be required. One comment maintains that
having both a location description and a location identifier could be
confusing to FDA during an investigation. One comment suggests allowing
for flexibility for the location identifier, with options to provide a
name and physical location or a unique identifier, potentially using
the last 5 to 6 digits of the FDA registration number. However, one
comment suggests that FDA facility registration numbers should not be
used as a location identifier. One comment suggests that FDA assign
location identifiers for all establishments that produce, transform,
package, or label foods covered by this rule. Finally, some comments
state that location identifiers are not commonly used in business at
all or are not commonly used to refer to the physical location of
production; instead, the comments maintain that a location identifier
often refers to a commercial location such as headquarters, sales, or
customer service locations.
    (Response 267) We recognize that the proposed requirements to keep
both a ``location description'' and a ``location identifier'' for an
entity were confusing to many commenters. Therefore, we have removed
the requirement to keep a ``location identifier'' and deleted the
definition of ``location identifier'' from the final rule. We conclude
that the information specified in the definition of ``location
description'' is adequate to identify where an entity is physically
located, and comments indicate that some covered entities do not
currently use location identifiers. Businesses that use location
identifiers, such as to differentiate between intracompany locations
(e.g., store numbers), may choose to include that information as part
of their location description. This could be done either by adding it
to the required information or by using it as a shorthand for some or
all of the required information, provided that a glossary or key is
maintained (and, if necessary, shared) to indicate the complete
physical address and other required information relating to the
specific location.
    (Comment 268) Several comments recommend expanding the definition
of ``location identifier'' to include the GS1 Global Location Number
(GLN). According to comments, the GLN has wide global acceptance and is
endorsed by the FAO. Comments suggest adopting the GLN as the location
identifier, maintaining that the GLN better identifies fishing vessels
and that it would be useful for identifying packing and cooling
locations. On the other hand, one comment supports the definition of
``location identifier'' for fishing vessels as proposed.
    (Response 268) We have deleted the proposed requirement to maintain
a location identifier (including, where applicable, a fishing vessel
identifier) for all CTEs. Consequently, we have also deleted the
definition of ``location identifier.'' However, businesses that use
GLNs may choose to include that information as part of their location
description. This could be done either by adding it to the required
information or by using it as a shorthand for some or all of the
required information, provided that a glossary or key is maintained
(and, if necessary, shared) to indicate the complete physical address
and other required information relating to the specific location.
19. Lot
    We proposed to define ``lot'' to mean the food produced during a
period of time at a single physical location and identified by a
specific code. The proposed definition further stated that a lot may
also be referred to as a batch or production run. As discussed below,
we are deleting this definition to avoid possible confusion with the
term ``traceability lot.''
    (Comment 269) Several comments express confusion about the
difference between ``lot'' and ``traceability lot,'' maintaining that
the need for two terms was unclear. (As discussed below, we proposed to
define ``traceability lot'' as a lot of food that has been originated,
transformed, or created.) Some comments recommend that FDA should
define ``lot'' by using current industry terminology to better align
with currently used processes and standards, and remove new terms that
are causing confusion, such as ``traceability lot.''
    (Response 269) We agree there was potential for confusion between
the terms ``lot'' and ``traceability lot.'' We have deleted the
definition of ``lot'' from the final rule. Because the rule is focused
on keeping and providing to subsequent supply chain entities the
traceability lot code, which applies to a ``traceability lot'' of an
FTL food, we conclude that it is not necessary to have an additional
definition for ``lot.'' Regarding consensus terminology, we have
reviewed traceability standards and initiatives both domestically and
internationally and we are not aware of a consensus definition of
``lot.'' For the purposes of subpart S, we think the important thing is
to have a shared understanding of the term ``traceability lot,'' the
definition of which is discussed below. Businesses may choose to assign
additional lot codes that are internal to their operations, but such
practices are beyond the scope of this rule and therefore do not
require a definition of ``lot.''
20. Manufacturing/Processing
    We proposed to define ``manufacturing/processing'' to mean making
food from one or more ingredients, or synthesizing, preparing,
treating, modifying, or manipulating food, including food crops or
ingredients. The proposed definition further stated that examples of
manufacturing/processing activities include baking, boiling, bottling,
canning, cooking, cooling, cutting, distilling, drying/dehydrating RACs
to create a distinct commodity (such as drying/dehydrating grapes to
produce raisins), evaporating, eviscerating, extracting juice,
formulating, freezing, grinding, homogenizing, irradiating, labeling,
milling, mixing, packaging (including modified atmosphere packaging),
pasteurizing, peeling, rendering, treating to manipulate ripening,
trimming, washing, or waxing. Finally, the proposed definition noted
that, for farms and farm mixed-type facilities, manufacturing/
processing does not include activities that are part of harvesting,
packing, or holding. We did not receive any comments on this definition
and are finalizing it as proposed, which is identical to the definition
in Sec.  1.227.
21. Mixed-Type Facility
    We proposed to define ``mixed-type facility'' to mean an
establishment that engages in both activities that are exempt from
registration under section 415 of the FD&C Act and activities that
require the establishment to be registered. The definition further
states that an example of such a facility is a ``farm mixed-type
facility,'' which is an establishment that is a farm, but also conducts
activities outside the farm definition that require the establishment
to be registered. We did not receive any comments on the definition of
``mixed-type facility'' and are finalizing it as proposed, which is
identical to the definition in Sec.  1.227.
22. Nonprofit Food Establishment
    We proposed to define ``nonprofit food establishment'' to mean a
charitable entity that prepares or serves food directly to the consumer
or

otherwise provides food or meals for consumption by humans or animals
in the United States. The definition further stated that the term
includes central food banks, soup kitchens, and nonprofit food delivery
services and notes that to be considered a nonprofit food
establishment, the establishment must meet the terms of section
501(c)(3) of the U.S. Internal Revenue Code.
    (Comment 270) One comment asks whether hospitals and nursing homes
are considered nonprofit food establishments.
    (Response 270) Hospitals and nursing homes are nonprofit food
establishments under the rule (and thus would be exempt from subpart S
under Sec.  1.1305(o)) if they meet the definition of ``nonprofit food
establishment'' that we proposed and are finalizing, i.e., they are a
charitable entity that prepares or serves food directly to consumers or
otherwise provides food or meals for consumption by humans or animals
in the United States, and they meet the terms of section 501(c)(3) of
the U.S. Internal Revenue Code. Hospitals and nursing homes that are
not nonprofit food establishments might be eligible for other
exemptions or partial exemptions, such as the exemption for small RFEs
and restaurants in Sec.  1.1305(i).
23. Originating
    We proposed to define ``originating'' as an event in a food's
supply chain involving the growing, raising, or catching of a food
(typically on a farm, a ranch, or at sea), or the harvesting of a non-
produce commodity. As explained below, we have removed this term from
the final rule.
    (Comment 271) One comment asks that we replace ``growing'' with
``harvesting'' in the definition of ``originating.'' The comment
maintains that traceability lot codes normally are not assigned to food
before it is harvested.
    (Response 271) We agree that traceability lot codes usually are not
assigned to a food until after it is harvested, and we have made
several changes to the rule to reflect this, including adoption of
requirements applicable to the initial packer of a food not obtained
from a fishing vessel and the first land-based receiver of a food
obtained from a fishing vessel (see Sec. Sec.  1.1330 and 1.1335). As a
result of these and other changes, the final rule no longer includes
requirements concerning originators or originating of foods, and we are
deleting the definition of ``originating.''
24. Originator
    We proposed to define ``originator'' to mean a person who grows,
raises, or catches a food, or harvests a non-produce commodity. We did
not receive any comments on this definition. Consistent with the
deletion of the term ``originating,'' we are deleting the definition of
``originator'' from the rule.
25. Packing
    We proposed to define ``packing'' to mean placing food into a
container other than packaging the food, including re-packing and
activities performed incidental to packing or re-packing a food (e.g.,
activities performed for the safe or effective packing or re-packing of
that food (such as sorting, culling, grading, and weighing or conveying
incidental to packing or re-packing)), but not including activities
that transform a RAC, as defined in section 201(r) of the FD&C Act,
into a processed food as defined in section 201(gg) of the FD&C Act.
The proposed definition was identical to the definition in Sec.  1.227.
We are finalizing the definition of ``packing'' as proposed, except
that we are deleting the reference to the definition of ``raw
agricultural commodity'' in section 201(r) of the FD&C because we are
adding a definition of ``raw agricultural commodity'' to the rule,
stating that the term means ``raw agricultural commodity'' as defined
in section 201(r) of the FD&C Act. We note that, in general, packing
means putting a product into a container that is distributed in
commerce (e.g., packing clamshell containers into a cardboard box for
shipment), and does not include placing a product into a temporary
container to move it, such as from a field to a packinghouse.
    (Comment 272) Some comments state that the proposed definition of
``packing'' conflicts with practices used for seafood, especially
molluscan shellfish. The comments maintain that activities such as
sorting and culling are associated with harvesting for seafood,
particularly molluscan shellfish. The comments ask that we revise the
definition of ``packing'' to focus on activities associated with the
first receiver KDEs to be more consistent with the seafood HACCP
regulation.
    (Response 272) We understand that industries handling different FTL
foods sometimes use the same terms differently. The definition of
``packing'' we proposed is used in other FDA regulations, and we are
finalizing it as proposed (except for the small edit described above,
which matches other FSMA regulations that also define ``raw
agricultural commodity'' separately) for consistency with those
regulations. In response to comments, the final rule deletes proposed
requirements associated with the first receiver of an FTL food; KDEs
related to packing will need to be kept when an entity performs the
initial packing of a RAC (other than a food obtained from a fishing
vessel) (see Section V.K of this document). As the comment mentions
molluscan shellfish, we note that the final rule includes an exemption
for certain raw bivalve molluscan shellfish (Sec.  1.1305(f)).
26. Person
    We proposed to define ``person'' as it is defined in section 201(e)
of the FD&C Act, i.e., as including an individual, partnership,
corporation, and association. We are finalizing the definition of
``person'' as proposed.
    (Comment 273) Some comments request that we reconsider using
``person'' to describe both people and companies. One comment asks how
``person'' applies to multi-location corporations.
    (Response 273) We decline to revise the definition of ``person,''
which is a term and definition used in the subpart J regulation and
throughout the FD&C Act. Because persons who manufacture, process,
pack, or hold FTL foods under Sec.  1.1300 of the final rule could
include both individuals and companies, it is appropriate that the
definition include individuals along with partnerships, corporations,
and associations. Multi-location corporations might have different
corporate structures and practices, and the final rule includes
flexibility to account for this fact. For example, a multi-location
corporation may choose to maintain all of the required records
associated with its various branches in a central location, as long as
such records can be provided to FDA within 24 hours of request for
official review (see Sec.  1.1455(c)(2)). We also note that, as
discussed in Response 276, the final rule specifies that ``shipping''
includes sending an intracompany shipment of food from one location at
a particular street address of a firm to another location at a
different street address of the firm.
27. Physical Location Name
    We proposed to define ``physical location name'' to mean the
word(s) used to identify the specific physical site of a business
entity where a particular critical tracking event occurs. The
definition further stated that a physical location name might be the
same as an entity's business name if the entity has only one physical
location. We did not receive any comments on

this definition, but we received comments about the proposed definition
of ``location description,'' which included the phrase ``physical
location name.'' As discussed previously, we have deleted ``physical
location name'' as a component of ``location description'' and are
therefore deleting the definition of ``physical location name'' from
the rule.
28. Point of Contact
    We proposed to define ``point of contact'' as an individual having
familiarity with an entity's procedures for traceability, including
their name, telephone number, and, if available, their email address
and Fax number. As explained below, we have made changes to the
definition of ``point of contact'' in response to comments.
    (Comment 274) Many comments express concern about proposed
provisions requiring the identification of a point of contact. Some
comments maintain that, with employee turnover rates, requiring an
individual's name for the point of contact would increase costs and
paperwork burden, introduce an opportunity for updating errors, and
create privacy issues in sharing the information. Some comments
maintain that requiring names and phone numbers of points of contact to
be passed through the entire chain puts individuals at unnecessary risk
for the compromise of their privacy, and could potentially make them an
information target for a criminal organization and raise liability
concerns if such an individual is targeted for information after a data
breach of information stored by a downstream entity. Some comments
acknowledge the importance of maintaining a record of the point of
contact but maintain that this information is not currently
communicated within most of the produce industry, and the comments
request guidance on feasible options to demonstrate compliance with
this requirement. Many comments oppose the proposed requirements to
provide a point of contact for the lot code generator, stating that
sharing this information may disclose confidential information about a
firm's suppliers. Some comments ask that we provide additional
justification to explain the benefit of including a point of contact
requirement, asserting that it is unnecessary to have the name of the
individual responsible for a covered entity's traceback program for FDA
to perform an efficient traceback. Other comments ask that we provide
more flexibility to allow firms to determine the best way to provide
information on the designated point of contact. These comments
recommend changing the definition of ``point of contact'' to allow for
reference to a job title or a more general reference to a responsible
individual, rather than stating an individual's name.
    (Response 274) We appreciate the comments' concerns about the
privacy of individuals serving as a firm's point of contact. To address
these privacy concerns, we have deleted proposed requirements for firms
to provide point of contact information to other entities in the supply
chain. In the final rule, the only requirements regarding a point of
contact are in the traceability plan (which is not shared with other
entities in the supply chain) (Sec.  1.1315(a)(4)) and in the
procedures for requesting a waiver for an individual entity (Sec.
1.1415(a)).
    To further address the concerns raised in the comments, we have
revised the definition of ``point of contact'' to mean an individual
having familiarity with an entity's procedures for traceability,
including their name and/or job title, and phone number. We conclude
that providing a job title in place of (or in addition to) an
individual's name allows firms to provide essential point of contact
information without infringing on the privacy of employees and provides
flexibility for firms to decide how best to identify the individual or
individuals who have familiarity with the firm's procedures for
traceability.
    On our own initiative, we have removed the proposed requirement to
provide the email address and Fax number for the point of contact. The
proposed requirement was to provide these pieces of information ``if
available,'' and we determined that neither was necessary. When
reaching out to a point of contact, we will generally do so by phone,
and at that point we can get any other contact information that is
needed.
    (Comment 275) Several comments recommend that the rule provide
flexibility in the number of points of contact a firm can provide to
fulfill a point of contact requirement, noting that some covered
entities may have an entire team of people tasked with this
responsibility.
    (Response 275) We agree with the comments. As stated above, we are
revising the definition of ``point of contact'' to allow for the use of
job titles in place of (or in addition to) an individual's name. As
noted in Response 450, we have deleted as unnecessary the use of
``(s)'' (indicating pluralization of terms as applicable) from all
provisions in which we had proposed to include it (except with respect
to the definition of ``retail food establishment,'' where we have
retained it so that the definition is the same as in other FDA
regulations).
29. Produce
    We proposed to define ``produce'' as it is defined in Sec.  112.3
in the produce safety regulation. We did not receive any comments on
this definition and are finalizing it as proposed.
30. Product Description
    We are deleting the proposed definition of ``traceability product
description'' and replacing it with a definition of ``product
description.'' The final rule defines ``product description'' to mean a
description of a food product, which includes the product name
(including, if applicable, the brand name, commodity, and variety),
packaging size, and packaging style. The definition further states that
for seafood, the product name may include the species and/or acceptable
market name. We discuss comments on the proposed definition of
``traceability product description''--which are relevant to the
definition of ``product description''--in Response 299.
31. Raw Agricultural Commodity
    For clarity in understanding certain provisions of subpart S that
include the term ``raw agricultural commodity,'' we are adding a
definition of the term identical to that found in other FDA
regulations, including the produce safety regulation. Thus, ``raw
agricultural commodity'' means ``raw agricultural commodity'' as
defined in section 201(r) of the FD&C Act.
32. Receiving
    We proposed to define ``receiving'' as an event in a food's supply
chain in which a food is received by a customer (other than a consumer)
at a defined location after being transported (e.g., by truck or ship)
from another defined location. As discussed below, we are making
several changes to the definition of ``receiving'' in response to
comments.
    (Comment 276) One comment supports specifying that ``receiving''
only involves receipt of food by a ``customer'' other than a consumer.
On the other hand, several comments recommend changing ``customer'' to
``received by a different facility'' in the receiving definition. The
comments maintain that the proposed rule's inclusion of ``customer'' in
the definition of ``receiving'' makes it unclear whether the rule
applies to shipments among different locations under a single corporate
umbrella. One comment supports requiring records of intracompany
movements under the

rule. The comment describes shipments of foods on the FTL from a
retailer's distribution center to the retailer's stores, which the
comment asserts might be excluded under the proposed rule because the
ownership of the food does not change and the receiver is not a
``customer.'' The comment claims that this would create a serious gap
in traceability. To avoid this potential, the comment recommends
revising the definition of ``receiving'' to clarify that product
movement is between distinct or noncontiguous physical locations,
regardless of ownership.
    Conversely, several comments request that FDA exempt from the final
rule intracompany shipments of food, such as shipments between
manufacturers and internal warehouses and shipments between
manufacturers and third-party warehouses under the same company's
control. The comments assert that intracompany shipments do not provide
necessary traceback information because the records do not contain
either the supplier or the customer of the food. Further, the comments
state that additional recordkeeping is not needed for intracompany
movements because they would already be captured in a company's one-up,
one-back records because, according to the comments, subpart J has a
relevant exemption that is narrowly focused on vertically integrated
companies. A few of the comments request that food transported between
facilities owned or controlled by the same company be excluded from
maintaining shipping and receiving records, provided a record is
maintained of all locations where the product was stored or produced.
The comments argue that recordkeeping would be challenging due to the
frequency of intracompany movement of food, would require entities to
maintain redundant records, and would force companies to maintain
electronic recordkeeping. Another comment asserts that a new
traceability lot code should not be required when an ingredient is
transferred from one site to another within the same company. One
comment recommends that the final rule exclude movements between
entities that are ``under the ownership or operational control of a
single legal entity which may establish and maintain traceability
records in conformance with common, integrated, written procedures,''
to be consistent with the sanitary transportation of human and animal
food regulation exemption for intracompany food shipments.
    (Response 276) We decline to exempt intracompany shipments from the
final rule. We generally agree with the comments that are concerned
that failure to record certain intracompany movements of food could
create the potential for gaps in traceability, and we have revised the
definition of ``receiving'' to address this concern. First, we have
deleted the reference to ``customer'' so that receiving is now defined
as an event in a food's supply chain in which a food is received by
someone other than a consumer after being transported (e.g., by truck
or ship) from another location. Second, we have added to the definition
a statement that receiving includes receipt of an intracompany shipment
of food from one location at a particular street address of a firm to
another location at a different street address of the firm. Under the
revised definition, the example provided in the comment of movement of
an FTL food between a retailer's distribution center to the retailer's
stores would be considered a receiving event at the stores. If this
were not the case, FDA would not be able to determine precisely which
traceability lot codes were available for purchase at an RFE during a
timeframe of interest. We would need to rely on receiving records at
the distribution center and the firm's inventory practices, which might
significantly expand the number of suspect traceability lot codes to be
traced, increasing investigation time and reducing effectiveness.
    Contamination of foods may occur at any point in the supply chain,
including warehouses. Therefore, records of intracompany movements
between warehouses are important for traceability and may help identify
where contamination occurred. Relying on a firm's business practices,
as some comments propose, rather than the KDEs required by the final
rule may reduce traceback effectiveness and increase investigation
time.
    Movement of a food within a single location (at a particular street
address) of a firm does not constitute receiving. Examples of movements
within a location that would not be considered receiving events include
the following: (1) moving received foods from the loading dock to the
warehouse; (2) moving ingredients from storage to processing; and (3)
moving foods from processing to the warehouse or shipping dock.
Intracompany movements of ingredients would not require a new
traceability lot code (Sec.  1.1320 describes the situations in which a
traceability lot code must be assigned).
    The final rule does not prescribe how firms should maintain
records, only what information should be maintained. Electronic records
of intracompany shipments are not required. Further, firms do not need
to duplicate existing records, if those records contain some or all of
the required information (Sec.  1.1455(f)); in addition, firms do not
need to keep all of the required information in a single set of records
(Sec.  1.1455(g)).
    Finally, the goals of the food traceability regulation are
different from the goals of the sanitary transportation regulation.
Knowing where food has been is important for traceability. Therefore,
we are not providing an exemption for intracompany food shipments.
    (Comment 277) Comments in favor of excluding cross-docking from the
rule argue in favor of including the word ``customer'' in the
definition of ``receiving'' so as to exclude the cross-docking
facility, which is not a ``customer.''
    (Response 277) We have removed the word ``customer'' from the
definition of ``receiving'' (see Response 276). We discuss handling of
cross-docking under the final rule in Section V.E.20.g of this document
and Response 244.
    (Comment 278) One comment seeks clarification on whether the term
``receiving'' would apply to transporting RACs from the orchard or
field to the packinghouse, because the grower often maintains ownership
of the food and therefore there is no ``customer.''
    (Response 278) While the term ``receiving'' as defined in subpart S
could include movement of RACs from an orchard or field to a
packinghouse at a different physical address, we have excluded such
movements from the receiving CTE in the final rule. As discussed in
Section V.N.3 of this document, Sec.  1.1345(c) of the final rule
specifies that Sec.  1.1345 (concerning records to kept when receiving
a food) does not apply to receipt of a food that occurs before the food
is initially packed (if the food is a RAC not obtained from a fishing
vessel) or to the receipt of a food by the first land-based receiver
(if the food is obtained from a fishing vessel).
    (Comment 279) One comment asks that we not consider receipt of a
product at a third-party warehouse under the control of a given
manufacturer to be a ``receiving'' event, maintaining that a
requirement that the third-party warehouse assign a new traceability
lot code when receiving an FTL food would not lead to efficient
tracing.
    (Response 279) We do not agree that receipt of an FTL food by a
third-party warehouse should not be a ``receiving'' event. We conclude
that having the third-party warehouse keep a record of its receipt of
the food is necessary to ensure adequate traceability of the food.

However, we agree that the third-party warehouse should not assign a
new traceability lot code to the food. The third-party warehouse's
receipt of the food at its physical site would constitute ``receiving''
and would therefore be subject to the requirements in Sec.  1.1345.
However, a firm that receives an FTL food and only holds it at a
location (and perhaps subsequently ships it from that location)
generally may not give the food a new traceability lot code. The
circumstances in which a firm may assign a traceability lot code are
limited (see Sec.  1.1320), and a firm may not assign a traceability
lot code solely due to its receipt of a food unless it receives a food
that has no traceability lot code from an entity that is exempt from
the rule (see Sec.  1.1345(b)(1)).
33. Reference Document
    In partial response to comments about the proposed definition of
``reference record,'' which is discussed below, we are deleting that
term from the rule and we are adding a definition of ``reference
document.'' The final rule defines ``reference document'' to mean a
business transaction document, record, or message, in electronic or
paper form, that may contain some or all of the KDEs for a CTE in the
supply chain of a food. The definition further states that a reference
document may be established by a person or obtained from another
person. The definition also states that reference document types may
include, but are not limited to, BOLs, POs, ASNs, work orders,
invoices, database records, batch logs, production logs, field tags,
catch certificates, and receipts.
34. Reference Document Number
    Consistent with the change from ``reference record'' to ``reference
document,'' we are deleting the proposed definition of ``reference
record number'' as described below, and adding a definition of
``reference document number'' to mean the identification number
assigned to a specific reference document. The proposed definition of
``reference record number'' had included similar language and had also
provided the examples of a PO number, BOL number, or work order number.
We have deleted these examples from the definition of ``reference
document number'' because examples of reference documents are provided
in the definition of ``reference document.'' We note that, in addition
to being KDEs for certain CTEs, reference document numbers might be
used in an electronic sortable spreadsheet requested by FDA in
accordance with Sec.  1.1455(c)(3) to indicate the particular reference
documents that contain information included in the spreadsheet.
35. Reference Record
    We proposed to define ``reference record'' as a record used to
identify an event in the supply chain of a food, such as a shipping,
receiving, growing, creating, or transformation event. The proposed
definition further stated that types of reference records include, but
are not limited to, BOLs, POs, ASNs, work orders, invoices, batch logs,
production logs, and receipts.
    As discussed above, in the final rule we are replacing the term
``reference record'' with ``reference document.'' We are also changing
the definition in response to comments, as discussed below.
    (Comment 280) One comment suggests adding ``movement documents'' to
the definition's list of types of reference records to provide
flexibility to allow companies to use existing records to meet the
requirements of the rule.
    (Response 280) We decline to make this change because we are not
certain that ``movement document'' is a widely used term in the food
industry. However, the list of types of reference documents in the
definition of ``reference document'' is non-exclusive, and firms may