would have required all farms to provide information to the subsequent
receiver regarding the origination, harvesting, cooling, and packing of
each traceability lot of food they shipped, we conclude that it is more
appropriate and less burdensome to have harvesters and coolers provide
information about the activities they perform to the initial packers of
RACs. This approach also allows for flexibility to accommodate the
varying business models and types of entities that can be involved in
harvesting and cooling RACs before they are initially packed.
    For these reasons, Sec.  1.1325 of the final rule sets forth
requirements for records that persons who conduct harvesting or cooling
before initial packing must keep and provide to the initial packer.
Section 1.1325(a)(1) specifies that for each RAC (not obtained from a
fishing vessel) on the FTL that is harvested, the harvester must
maintain records containing the following information: the location
description for the immediate subsequent recipient (other than a
transporter) of the food; the commodity and, if applicable, variety of
the food; the quantity and unit of measure of the food (e.g., 75 bins,
200 pounds); the location description for the farm where the food was
harvested; for produce, the name of the field or other 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;
for aquacultured food, the name of the container (e.g., pond, pool,
tank, cage) from which the food was harvested (which must correspond to
the container name used by the aquaculture farmer) or other information
identifying the harvest location at least as precisely as the container
name; the date of harvesting; and the reference document type and
reference document number.
    Similarly, Sec.  1.1325(b)(1) specifies that for each RAC (not
obtained from a fishing vessel) on the FTL that is cooled before it is
initially packed, the cooler of the RAC must maintain records
containing the following information: the location description for the
immediate subsequent recipient (other than a transporter) of the food;
the commodity and, if applicable, variety of the food; the quantity and
unit of measure of the food (e.g., 75 bins, 200 pounds); the location
description for where the food was cooled; the date of cooling; the
location description for the farm where the food was harvested; and the
reference document type and reference document number.
    In addition to these requirements to maintain certain records,
Sec.  1.1325 of the final rule also requires harvesters and coolers to
provide certain information to the initial packer of the RAC they
harvest or cool. Section 1.1325(a)(2) specifies that for each RAC (not
obtained from a fishing vessel) on the FTL that is harvested, the
harvester must provide (in electronic, paper, or other written form)
its business name, phone number, and the information (listed above)
that it must keep (except for the reference document type or reference
document number) to the initial packer of the RAC, either directly or
through the supply chain. Similarly, Sec.  1.1325(b)(2) requires
coolers of RACs (not obtained from a fishing vessel) to provide (in
electronic, paper, or other written form) the information the cooler
must keep (except for the reference document type or reference document
number) to the initial packer of the RAC, either directly or through
the supply chain. These provisions allow flexibility for harvesters and
coolers to directly provide the required information to the initial
packer or to have another entity in the supply chain, such as the farm
where the RAC was grown, a third-party entity directing the movement of
the RAC, or a supply chain partner who will handle the food before it
reaches the initial packer, provide the information to the initial
packer. However, we note that while supply chains have the flexibility
to determine how and by whom this information is sent to the initial
packer, it is the responsibility of harvesters and coolers to somehow
send the information to the initial packer, and it is the
responsibility of the initial packer to have the required information
for each FTL food they pack.
    Consistent with these provisions requiring harvesters and coolers
to provide certain information to the initial packers of the RACs they
harvest or cool, we have added provisions to the shipping and receiving
CTE requirements specifying that, for RACs not obtained from a fishing
vessel, the shipping and receiving KDEs do not apply to any shipment or
receipt of the food that occurs before it is initially packed. This
means that entities that harvest or cool RACs (not obtained from a
fishing vessel) before they are initially packed are not required to
keep and send the shipping and receiving KDEs. We conclude that this
approach is appropriate because the shipping and receiving KDEs are
linked to the traceability lot code and are designed to be used for
products that have already been assigned a traceability lot code and
packed for commercial distribution. The separate KDEs for harvesters
and coolers that we have established in Sec.  1.1325, and which take
the place of the shipping and receiving KDEs for these entities, are
better suited to the specific situation of food that has not yet been
initially packed. Because the KDEs in Sec.  1.1325 are not tied to a
traceability lot code, they can be organized in whatever way is
practical for the operation, for example, on a shipment-by-shipment or
day-by-day basis.
    (Comment 351) One comment expresses support for the fact that the
proposed rule does not require records of recipients of a food beyond
the immediate subsequent recipient, in accordance with section
204(d)(1)(L)(ii) of FSMA.
    (Response 351) We agree, and the final rule also does not require
records of recipients of a food beyond the immediate subsequent
recipient. The harvesting and cooling CTE requirements contain the only
provisions under which an entity would potentially have a direct
interaction with a recipient of a food beyond the immediate subsequent
recipient. Under Sec.  1.1325(a)(2) and (b)(2), the harvester and
cooler of a RAC not obtained from a fishing vessel are required to
``provide'' certain information about the

food to the initial packer of the food, who might not be the immediate
subsequent recipient of the food. As discussed above, we are taking
this approach in response to comments requesting greater flexibility
regarding methods of exchanging information at the beginning of the
supply chain. A food that has not yet been initially packed may, in a
short period of time, pass through the hands of multiple entities that
would have all been considered shippers and receivers under the
proposed rule. We have concluded that the structure of the proposed
rule, which involved each of these entities keeping shipping and
receiving records and (in the case of farms) passing along information
on the harvesting and cooling of the food, was overly prescriptive and
burdensome, particularly because it is our understanding that the
entities that handle a food before it is first packed will often have a
relationship with the entity that first packs the food, even if that
entity is not the immediate subsequent recipient. The final rule's
requirements for harvesters and coolers would provide the requested
flexibility. In accordance with section 204(d)(1)(L)(ii) of FSMA, Sec.
1.1325 would not require harvesters or coolers to keep records about
any entities (such as the initial packer) who are not the immediate
subsequent recipient of the food. Nor would Sec.  1.1325 necessarily
require the harvester or packer to send information directly to the
entity that initially packs the food. As discussed above, under Sec.
1.1325(a)(2) and (b)(2), the harvester or cooler may provide the
information directly to the initial packer or they may elect to pass
the relevant information through their supply chain partners (e.g., a
harvester providing information to a cooler) until it reaches the
initial packer.
    We also note that, although the exemptions in Sec.  1.1305(d)(6)
and (h)(2) potentially involve a series of written agreements meant to
ensure that a future supply chain entity will take a certain action
(e.g., apply a kill step or commingle a RAC), these provisions do not
require the exempt entity to know the identity of the future supply
chain entity that will take that action, let alone to keep a record of
who that future recipient will be. Instead, these provisions are
structured so that each supply chain member only needs to interact with
their immediate subsequent recipient to create the required written
agreements.
    (Comment 352) One comment suggests that the KDEs required for the
growing CTE include information on chemicals (e.g., pesticides) applied
on the farm, including days, times, types, and amounts of chemicals,
information on farm inspections, and any water testing performed on the
farm. The comment maintains that the addition of these KDEs would be
consistent with stricter standards that the comment asserts are needed
to address food safety hazards at the farm level.
    (Response 352) We decline to require growers of FTL foods or any
other entities subject to the rule to keep the suggested information on
chemicals. Such a requirement would not be consistent with the purpose
of the rule, which is to establish recordkeeping requirements for foods
designated for inclusion on the FTL to help us conduct rapid and
effective traceback when investigating foodborne illness outbreaks.
    (Comment 353) One comment asserts that although the proposed rule
did not define ``growing,'' it appears from the preamble of the
proposed rule that the requirement for linking the traceability lot
code to growing area coordinates applies to produce and sprouts but not
to aquacultured foods or foods from fishing vessels.
    (Response 353) As previously stated, we have deleted the
recordkeeping requirements for growing an FTL food in proposed Sec.
1.1325, which included a requirement for growers to keep a record of
the growing area coordinates for each traceability lot of food. Under
the final rule, a traceability lot code is not assigned for a RAC until
the RAC is initially packed (in the case of food not obtained from a
fishing vessel, including aquacultured seafood) or until the RAC is
received by the first land-based receiver (for food obtained from a
fishing vessel) (see Sec.  1.1320). In the case of produce, including
sprouts, that traceability lot code will be linked in the initial
packer's records to the name of the field or other growing area from
which the food was harvested (see Sec.  1.1330(a)(5)). In the case of
aquacultured food, the traceability lot code will be linked in the
initial packer's records to the name of the container from which the
food was harvested (see Sec.  1.1330(a)(6)). In both of those
situations, the name of the field or container must correspond to the
name used by the farmer, and the farmer is required under Sec.
1.1315(a)(5) to maintain a farm map as part of their traceability plan,
which must include geographic coordinates and any other information
needed to identify the location of each field or container. This
approach replaces the requirement in the proposed rule for the grower
to maintain records linking each traceability lot of food to the
growing area coordinates where the food was grown. For eggs, Sec.
1.1315(a)(5) specifically notes that the farm map requirement does not
apply to egg farms, and there is no obligation under Sec.  1.1330 for
an initial packer to maintain a record of the specific poultry house or
field where eggs were harvested. This is because, in the case of egg
farms, we think that the information the initial packer must maintain
under Sec.  1.1330(a)(4), identifying the location description for the
farm where the food was harvested, is sufficient, and we do not see a
traceability benefit to requiring more specific information about where
a specific lot of eggs was harvested (especially in light of the fact
that eggs are often collected from multiple poultry houses via a single
conveyor belt that moves through all of the houses, thus making it
impracticable to associate an egg with a specific poultry house). For
food obtained from a fishing vessel, as discussed below, the first
land-based receiver of the food must maintain records linking each
traceability lot of the food to, among other things, the locations for
the trip during which the food was caught (see Section V.L of this
document).
    (Comment 354) One comment asks that FDA reference, in the final
rule or a future guidance document, our ``Draft Guidance for Industry:
Classification of Activities as Harvesting, Packing, Holding, or
Manufacturing/Processing for Farms and Facilities'' (Ref. 27) to help
entities subject to the subpart S requirements understand how we will
classify certain activities of farms and facilities.
    (Response 354) We will consider whether to reference the draft
guidance on ``Classification of Activities as Harvesting, Packing,
Holding, or Manufacturing/Processing for Farms and Facilities'' in a
future guidance document related to the food traceability recordkeeping
requirements in subpart S. Section 1.1305 of the final rule defines
``farm'' to mean ``farm as defined in Sec.  1.328'' (except for
producers of shell eggs). As noted in Response 250, we plan to issue a
proposed rule revising the definition of ``farm'' in several food
safety regulations, including Sec.  1.328, and we might reissue the
above-noted draft guidance to align with any revision of the farm
definition we might adopt in that rulemaking. We recognize that there
is significant interest in how the term ``farm'' is defined, and we
will provide communications as needed to ensure that entities covered
by subpart S have clarity on this topic as the rulemaking related to
the farm definition proceeds.

    (Comment 355) One comment expresses concern about maintaining KDEs
related to cooling foods on the FTL because cooling can occur multiple
times and at multiple locations.
    (Response 355) We agree that foods can be cooled at multiple points
in the supply chain, and we believe it is important to traceability to
keep records of all of the locations where a food is held, including
all of the locations where cooling occurs. As discussed above, Sec.
1.1325(b) requires persons who cool a RAC (not obtained from a fishing
vessel) before the RAC is initially packed to keep certain records and
to provide certain information to the initial packer of the RAC. Once a
RAC is initially packed, anyone that subsequently cools the food would
be required to keep the KDEs applicable to shipping and receiving of
FTL foods under Sec. Sec.  1.1340 and 1.1345, respectively.
    (Comment 356) One comment maintains that because eggs are often
batched in lots based on weekly date of pickup and, within that large
lot, there would be many different data points on day and time of
cooling for the lot, requiring the transmission of this information to
a first receiver would be burdensome for both egg producers (especially
small ones) and first receivers. The comment suggests that compliance
with the refrigeration requirements of the egg safety regulation (21
CFR part 118 (part 118)) and the regulation for safe handling and
refrigeration of eggs (21 CFR part 115 (part 115)) should be regarded
as adequate documentation of the cooling of eggs, making additional
records under subpart S unnecessary; alternatively, the comment
suggests that records kept to meet the egg regulations should satisfy
any subpart S requirements.
    (Response 356) We disagree with the suggestion that maintaining and
providing records of cooling of eggs under subpart S is not necessary
for traceability. However, we think that revisions we have made in the
final rule will alleviate many of the concerns expressed in the
comment. As previously stated, Sec.  1.1325(b) of the final rule
requires that persons who cool RACs (including eggs) before they are
initially packed must keep and provide to initial packers certain
information on the cooling, including the date of cooling. Although
proposed Sec.  1.1350(b)(2)(iv) would have required egg farms to inform
the immediate subsequent recipient of the eggs of the time of cooling,
the time of cooling is not a required KDE under Sec.  1.1325(b).
Furthermore, under the final rule, egg producers are not required to
link the Sec.  1.1325(b) KDEs on cooling to a particular traceability
lot, as traceability lot codes are not assigned until the eggs reach
the initial packer (see Sec.  1.1320). As discussed above, the cooling
KDEs in Sec.  1.1325(b) can be organized in whatever way is practical
for the operation, such as on a shipment-by-shipment or day-by-day
basis. Finally, we agree that egg producers should be able to use
records they keep in accordance with part 115 or part 118 to comply
with applicable subpart S requirements (including those for cooling in
Sec.  1.1325(b)), and this is permitted under Sec.  1.1455(f) of the
final rule.

K. Records of Initial Packing (Sec.  1.1330)

    As previously discussed, the proposed rule included recordkeeping
requirements applicable to the first receiver of a FTL food (proposed
Sec.  1.1330), which the proposed rule defined 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. In addition to records of receipt,
the proposed rule required first receivers to establish and maintain
records containing and linking the traceability lot code of the food
received to the following information:
     The location identifier and location description of the
originator of the food;
     The business name, point of contact, and phone number of
the harvester of the food, and the date(s) and time(s) of harvesting;
     The location identifier and location description of the
place where the food was cooled, and the date and time of cooling (if
applicable); and
     The location identifier and location description of the
place where the food was packed, and the date and time of packing.
    We stated in the preamble to the proposed rule (85 FR 59984 at
60008) that we were proposing these recordkeeping requirements for
first receivers because we believed that a first receiver was the
person best positioned to maintain comprehensive information about the
origination and subsequent handling of a food, including information
identifying the persons who originated, harvested, cooled, and packed
the food. We stated that identifying the first receiver of a food as
the first person who purchases and takes physical possession of the
food would ensure that comprehensive records relating to the
origination and handling of the food are maintained by a single person
who both owns and possesses the food.
    However, in response to many comments opposing the designation of
``first receiving'' of a food as a CTE, we are deleting the proposed
first receiver requirements from the final rule. Instead, we are
establishing requirements for the initial packing of a RAC other than a
food obtained from a fishing vessel (in Sec.  1.1330) and for the
performance of the first land-based receiving of a food obtained from a
fishing vessel (in Sec.  1.1335). In accordance with this change (as
well as the deletion of the proposed CTE for growing of FTL foods,
including sprouts), Sec.  1.1330(b) specifies the requirements
applicable to the initial packing of sprouts (except soil- or
substrate-grown sprouts harvested without their roots). In the
following paragraphs, we discuss certain comments on the proposed
requirements for first receivers as they apply to the requirements for
initial packers, followed by a discussion of comments on the proposed
requirements related to sprout operations.
1. Initial Packing of a RAC Other Than a Food Obtained From a Fishing
Vessel
    (Comment 357) Several comments express opposition to the proposed
requirements for first receivers, maintaining that the requirements are
impractical, overly burdensome, unnecessary for traceback, confusing,
complicated, and challenging to implement, and that the cost of keeping
such records would exceed the benefit. Several of these comments
include suggestions for improvements if the first receiver requirements
are retained.
    Some comments maintain that, with respect to the produce industry,
most of the proposed first receiver KDEs are held by the packinghouse
where produce is initially packed and stored, but these facilities do
not meet the definition of a first receiver, either because they do not
purchase the produce or because they are considered farms. Other
comments assert that the KDEs associated with the first receiver CTE
are generally not shared between trading partners in the fresh produce
supply chain today, so requiring such sharing would be a departure from
existing industry event-based traceability practices. The comments
instead ask that the rule require that traceability event-based
information be kept by the performers of CTEs. Some comments also
express concerns about data privacy and sharing sensitive farm
information with parties that do not normally receive it, such as
brokers,

processors, retail buyers, and even competitors. Some comments maintain
that such data sharing would sometimes require changes to existing
contractual provisions that restrict this type of data sharing.
    (Response 357) We agree that the proposed requirements for first
receivers caused confusion among many commenters, might not have
aligned with some business practices in the produce industry, and could
have been challenging to implement in some cases. Therefore, we are
deleting the proposed requirements for first receivers from the final
rule. However, much of the information we had proposed to require first
receivers to keep remains critical information for traceability. We
agree with the comments stating that the traceability information we
proposed to require first receivers to maintain is often kept by
packers. Therefore, in the final rule we have replaced the proposed
requirements for first receivers of FTL foods with requirements for the
initial packing of a RAC (other than food obtained from a fishing
vessel) (Sec.  1.1330) and the first land-based receiving of a food
obtained from a fishing vessel (Sec.  1.1335).
    The KDEs that initial packers must keep under Sec.  1.1330(a) are
similar to the KDEs that a first receiver would have had to keep as a
receiver of an FTL food under proposed Sec.  1.1335 and as the first
receiver of the food under proposed Sec.  1.1330. Section 1.1330(a)(1)
of the final rule specifies that for each traceability lot of a RAC
(other than a food obtained from a fishing vessel) on the FTL that is
initially packed, the initial packer must maintain records containing
the following information and linking this information to the
traceability lot:
     The commodity and, if applicable, variety of the food
received (Sec.  1.1330(a)(1));
     The date the initial packer received the food (Sec.
1.1330(a)(2));
     The quantity and unit of measure of the food received
(e.g., 75 bins, 200 pounds) (Sec.  1.1330(a)(3));
     The location description for the farm where the food was
harvested (Sec.  1.1330(a)(4));
     For produce, the name of the field or other 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
(Sec.  1.1330(a)(5));
     For aquacultured food, the name of the container (e.g.,
pond, pool, tank, cage) from which the food was harvested (which must
correspond to the container name used by the aquaculture farmer) or
other information identifying the harvest location at least as
precisely as the container name (Sec.  1.1330(a)(6));
     The business name and phone number for the harvester of
the food (Sec.  1.1330(a)(7));
     The date of harvesting (Sec.  1.1330(a)(8));
     The location description for where the food was cooled (if
applicable) (Sec.  1.1330(a)(9));
     The date of cooling (if applicable) (Sec.  1.1330(a)(10));
     The traceability lot code the initial packer assigned
(Sec.  1.1330(a)(11));
     The product description of the packed food (Sec.
1.1330(a)(12));
     The quantity and unit of measure of the packed food (e.g.,
6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds) (Sec.
1.1330(a)(13));
     The location description for where the food was initially
packed (i.e., the traceability lot code source), and (if applicable)
the traceability lot code source reference (Sec.  1.1330(a)(14));
     The date of initial packing (Sec.  1.1330(a)(15)); and
     The reference document type and reference document number
(Sec.  1.1330(a)(16)).
    Because the information that initial packers must keep under Sec.
1.1330(a) is often shared with packers today, we do not believe that
data privacy will be as much of a concern for producers as it was with
the proposed requirement for farms to share information about the
origination, harvesting, cooling, and packing of a food with a first
receiver under proposed Sec.  1.1350(b)(2). However, we recognize that
some changes to current practices, including to contracts, may be
necessary for certain covered entities. With regard to comments asking
that information be kept only by those entities that performed an
activity and not shared with others in the supply chain, we reiterate
that the goal of this rulemaking is to increase the efficiency of
traceback investigations and therefore better protect public health.
Therefore, it is critical that we are able to determine as quickly as
possible the nodes in the supply chain where product was handled. Being
able to access information maintained by the initial packer about what
farm a RAC came from, who harvested it and when, and (if it was cooled)
where and when cooling was performed will shorten the time it takes to
perform tracebacks and, therefore, support the public health benefits
anticipated for the rule. For this reason, as discussed in Section V.J
of this document, Sec.  1.1325(a)(2) and (b)(2) require harvesters and
coolers to provide initial packers with this information.
    We also note that, in the proposed rule, we used the term
``returnable plastic containers'' as an example for unit of measure. We
have corrected that terminology in the final rule with ``reusable
plastic containers.''
    (Comment 358) One comment expresses concern that a requirement to
keep first receiver KDEs would discourage direct sourcing from farms by
RFEs and processors.
    (Response 358) As previously stated, we are deleting the proposed
first receiver requirements, which should eliminate any concerns
related to local sourcing posed by those requirements. We also note
that the final rule provides a partial exemption from the subpart S
requirements for RFEs and restaurants purchasing directly from a farm
(Sec.  1.1305(j)) and a full exemption for small RFEs and restaurants
(Sec.  1.1305(i)).
    (Comment 359) Some comments request information on how KDEs should
be linked to the traceability lot code.
    (Response 359) As stated in Response 333, Sec.  1.1330(a) requires
initial packers to maintain records that contain several KDEs
(including the traceability lot code) and that link this information to
a particular traceability lot of an FTL food. While the rule does not
prescribe how this linkage must be accomplished, examples include
placing the traceability lot code on a reference document for the
packing of the food that contains the relevant KDEs, or keeping records
in an electronic database that can sort data based on the traceability
lot code and provide the KDEs related to that traceability lot. These
are just two examples, and there are many other ways that firms might
choose to link KDEs to individual traceability lots. As set forth in
Sec.  1.1455(g), firms do not have to keep all of the information
required by subpart S in a single set of records, and firms might
maintain records for a specific traceability lot on multiple reference
documents, provided the information can all be linked together (e.g.,
by the fact that each document contains the traceability lot code). As
previously discussed, linking the traceability lot code with the other
KDEs for a CTE such as initial packing will help us efficiently trace
the movement of a product through the supply chain and appropriately
scope any regulatory or product actions.
    (Comment 360) Some comments assert that FDA's ability to conduct
investigations by navigating a single lot code being sent to multiple
firms, which

could be a first receiver at different points in their supply chain,
may be disrupted if or when a lot code is changed.
    (Response 360) Although we have deleted the term ``first receiver''
from the final rule, we agree that changes to a lot code can disrupt
traceability. As previously stated, Sec.  1.1320(a) requires that a
traceability lot code be assigned to an FTL food when it is initially
packed, received by the first land-based receiver, or transformed.
Because we conclude that changing the traceability lot code in other
circumstances can hinder traceback efforts, Sec.  1.1320(b) generally
prohibits establishment of a new traceability lot code when conducting
other activities, such as shipping, with the only exceptions being for
situations where an FTL food is received from a person to whom subpart
S does not apply.
    (Comment 361) One comment suggests we focus on the traceability lot
code, including a product identifier (GTIN) and internal lot code,
rather than the product description.
    (Response 361) We agree that traceability lot codes are a
fundamental component of the subpart S recordkeeping requirements. A
traceability lot code may include a product identifier such as a GTIN
and/or an internal lot code (provided the definition of ``traceability
lot code'' in Sec.  1.1310 is met), but firms are not required to use
GTIN or any other particular coding system or technology. On the other
hand, we do not agree that the product description should not be part
of the required KDEs for traceability. The final rule requires
maintaining and providing product descriptions because they contain
important distinguishing information about the product that can help us
trace the correct product during a traceback.
    (Comment 362) One comment asserts that the proposed requirements
for first receivers to maintain information on harvesting (Sec.
1.1330(a)(2)) and packing (Sec.  1.1330(a)(4)) should be limited to
``as applicable'' because the information may not be necessary for
tracing purposes for first receivers of aquacultured seafood. On the
other hand, one comment asks that packers be required to maintain
records supporting the production of the traceability lot code,
including the harvest location or field, harvest date, and cooling and
packing information.
    (Response 362) We do not agree that maintenance of harvesting and
packing information by initial packers may not be appropriate or
relevant to tracing food, including food obtained from aquaculture
operations. To identify the source of an FTL food, it is important to
obtain information about where it was harvested and where it was
initially packed. In traceback investigations, we need access to
records documenting the movement of the food being investigated,
particularly for locations in the supply chain where the food is
handled in a way that could introduce contamination. Therefore, Sec.
1.1330(a) includes requirements for initial packers to keep information
on, among other things, the harvesting of the RAC they pack, including,
for aquacultured food, the name of the container from which the food
was harvested (which must correspond to the container name used by the
aquaculture farmer) or other information identifying the harvest
location at least as precisely as the container name (Sec.
1.1330(a)(6)).
    (Comment 363) One comment asserts that requiring the first receiver
of a food to maintain the location identifier and location description
of the originator of the food is duplicative of the growing area
coordinates tied to the lot code. Instead, the comment suggests that we
require firms to keep the growing area coordinates and contact
information for the originator.
    (Response 363) As stated in Response 350, we have deleted the
proposed growing CTE, which included the requirement to document
growing area coordinates for each traceability lot of food. Instead, a
farm that grows or raises an FTL food (other than eggs) must maintain a
farm map showing the location and name of each field or other growing
area in which FTL foods are grown (or, in the case of aquaculture, the
location and name of each container in which FTL seafood is raised),
including geographic coordinates and any other information needed to
identify the location of each field, growing area, or container. The
harvester must maintain the location description for the farm from
which the food was harvested (see Sec.  1.1325(a)). As defined in Sec.
1.1310, the location description must include the physical location
address or geocoordinates. (As previously discussed, we have deleted
proposed requirements to keep location identifiers as KDEs for certain
CTEs.) For produce, the harvester also must maintain the name of the
field or other growing area from which the food was harvested, which
must correspond to the name used by the grower; and for aquaculture,
the harvester must maintain similar information relating to the
container from which the food was harvested. Information regarding both
the location description for the farm and the fields or containers from
which the food was harvested is passed by the harvester to the initial
packer, who will assign the traceability lot code to the food it packs.
The initial packer must link that traceability lot code and the other
KDEs (including the location description for the farm and the name of
the field or container from which the food was harvested) to the
relevant traceability lot.
    We do not think it is duplicative to require both a location
description for the farm where the food was harvested and (in the case
of produce and aquacultured seafood) the name of the field or container
from which the food was harvested. The location description is
important for traceability because it helps FDA contact and visit a
farm. The field number and container number serve different
traceability purposes because they can help narrow the scope of an
action such as a recall. (They can also be helpful after the traceback
for root-cause investigations.) For small farms consisting of a single
field, the field name and farm map might not add substantially more
detail than the location description for the farm, but in most
situations this will not be the case. Most farms have multiple fields,
and some farms have fields that are not at all adjacent to each other
(in some cases they are miles apart), in which case a single location
description for the farm would provide considerably less precise
information about where the food was grown than a farm map combined
with a field name. We decline to require that geographic coordinates be
passed through the supply chain, because we received comments
expressing privacy concerns about sharing that information. By
requiring the harvester to pass along the field or container name,
while allowing the geographic coordinates to remain unshared in the
grower's traceability plan, we can achieve the necessary level of
traceability without requiring the sharing of sensitive information.
    (Comment 364) Some comments suggest that clarity is needed
concerning the proposed first receiver requirements to keep records
about the harvester of the food in situations when a harvester is the
owner of the company rather than a field employee.
    (Response 364) Under the proposed requirements, the first receiver
would have been responsible for maintaining harvesting information on
harvested FTL foods, including the business name, point of contact, and
phone number of the harvester. As discussed previously, we have removed
the proposed requirements relating to the first receiver. Under Sec.
1.1330 of the final rule, the initial packer must keep, among other
KDEs, the business name

and phone number for the harvester (Sec.  1.1330(a)(7)), which the
harvester must provide to the initial packer in accordance with Sec.
1.1325(a)(2). Because the final rule does not require harvesters to
provide the initial packer with a point of contact or the name of an
individual, this eliminates any need to distinguish between the entity
that owns the harvesting company and a field employee.
    (Comment 365) Several comments request removal of the proposed
requirement for first receivers to maintain dates of cooling and
harvesting. One comment expresses support for maintaining records
related to the date of harvesting but not the date of cooling.
    (Response 365) We decline to eliminate requirements to record the
dates of harvesting and cooling. We believe that dates for both
harvesting and cooling are critical for helping us determine whether
particular products may or may not have been impacted by a
contamination event. Because we have removed the proposed first
receiver requirements from the final rule, requirements relating to the
date of harvesting and cooling are now found in the harvesting and
cooling KDEs in Sec.  1.1325, and in the initial packing KDEs in Sec.
1.1330.
    (Comment 366) Several comments suggest that time be removed as a
KDE from all of the CTEs where it was proposed. Some comments maintain
that requiring firms to record the time an event occurred would create
an unnecessary burden, would not enhance traceability, or is not
legally permissible. One comment asserts that it is not necessary to
know when a food was packed to perform a traceback investigation, and
that it would make recordkeeping requirements overly burdensome to
maintain that information. Some comments assert that documenting time
as a KDE would be challenging due to variability as to when in the
event the time should be identified. One comment suggested that time
should be optional or only required if applicable. However, one comment
claims that packers already maintain records on the date and time of
packing, so this information could easily be shared with FDA with
little additional burden.
    (Response 366) The proposed rule included KDEs relating to the time
of cooling, packing, harvesting, receipt, and shipping. We agree with
the comments asserting that the time of day when these events occurred
is not information that is essential for effective traceability.
Therefore, we have deleted all proposed KDEs regarding the time an
event occurred. However, for operations that are able to keep records
relating to time when an event occurred, we note that such records can
be helpful during traceability, including in narrowing the scope of an
action such as a recall. We therefore encourage the keeping of such
records when possible, although the information is not required under
subpart S.
    (Comment 367) One comment asserts that any firm that packs,
packages, or ships a product should be required to maintain grower-
level records (e.g., grower/harvester, field location and/or production
location, harvest date/time).
    (Response 367) As stated in Response 350, the final rule requires
the initial packers of RACs on the FTL not obtained from a fishing
vessel to maintain much of the information mentioned in the comment.
However, once a food has been initially packed, entities other than the
initial packer who ship the food are not required to keep such
information. As discussed in Section V.M of this document, entities
that ship a packed RAC (or any other FTL food) must maintain and
provide to the immediate subsequent recipient the location description
for the traceability lot code source or the traceability lot code
source reference for the food, which should enable us to quickly
identify the initial packer in the event of an outbreak. Once the
initial packer has been identified, they can provide FDA with the type
of grower-level information the comment discusses. We conclude that
these requirements will allow for sufficient efficiency during
traceback without unnecessarily burdening entities in the supply chain
by requiring them to keep and share more information than needed.
    (Comment 368) Several comments ask that we delete requirements to
record the location identifier and location description of where the
food was packed. One comment asserts that it is not necessary to know
where a food was packed in order to perform a traceback investigation,
and maintains that keeping this information would be overly burdensome.
Some comments suggest that location information should either be
optional or eliminated entirely for multiple CTEs, including
transforming, receiving (including first receiver), and creation. One
comment asserts that location identifiers should only have to be
maintained if they are supplied by a shipper.
    (Response 368) As previously stated, we have deleted proposed
requirements to maintain a record of location identifiers. However, we
do not agree that location information (in the form of location
descriptions) is not necessary for traceability. As stated in the
preamble to the proposed rule (85 FR 59984 at 59987), traceback begins
at the end of the supply chain at the point of purchase or point of
service (e.g., grocery stores and restaurants) and follows the food
product back through the points of distribution, processing, and
production to determine the source of the product and its ingredients.
Following the movement of a food through its supply chain, including
events such as packing, receiving, shipping, and transforming, is an
essential part of any traceback investigation.
    The final rule includes recordkeeping requirements for initial
packing because packing is the point in the supply chain where RACs are
packed into a form that can be put into distribution. Because the
packed product often is the first form of the food that has a
production code assigned to it, the final rule requires initial packers
to assign a traceability lot code to the RACs they initially pack (see
Sec.  1.1320). Given the importance of packing in defining the
traceable product, we disagree with comments that it would be overly
burdensome to keep and provide information on the location where a food
was packed. Similarly, it is important to have information to identify
the location where food was transformed, as that is another location
where a traceability lot code must be assigned, and it is important to
know the locations of shippers and receivers in case we need to visit
those entities in the course of an investigation. Initially in a
traceback, we might try to skip locations that only perform shipping
and receiving, but we need to know those locations so that we can
follow each physical movement of food should an investigation lead us
to such a site. Having information on shipping and receiving locations
is also critical in traceforward activities where we are tracking the
movement of potentially contaminated food forward in distribution from
the point of production.
    (Comment 369) One comment suggests that first receivers be required
to maintain records of the quantity and unit of measure of food
received. However, one comment suggests that it is not necessary and
would be overly burdensome.
    (Response 369) Although we have deleted the proposed first receiver
requirements, we believe that quantity and unit of measure are
important KDEs for all CTEs in the final rule. These KDEs assist
industry and the Agency in understanding and tracking how much of a
product was harvested, cooled, packed, received, transformed, or

shipped as the food was handled and moved through the supply chain, as
well as how much product would have been available for purchase in a
given time period at RFEs and restaurants. Information on quantity and
unit of measure is also critical when there is a need for an action,
such as a recall, as a result of a traceback or traceforward.
    (Comment 370) One comment maintains that the send-only KDEs in
proposed Sec.  1.1350(b)(2) effectively duplicate the KDEs kept by the
first receiver.
    (Response 370) As previously stated, we have deleted the proposed
requirements for first receivers. We have also deleted the requirement
in proposed Sec.  1.1350(b)(2) that would have required all farms to
pass certain information through the supply chain until it reached the
first receiver. As discussed in Response 351, we conclude that it is
more appropriate and less burdensome to have harvesters and coolers
provide information about the activities they perform to the initial
packers of RACs.
    More generally, we recognize that in many cases the KDEs that must
be sent by an entity to the immediate subsequent recipient are closely
aligned with the KDEs that the recipient is required to maintain. This
is intentional, as it helps ensure that the entity receiving the food
will have the information they need, that any inaccuracies in the data
can be quickly identified, and that both entities will maintain the
information in a similar way, which helps us link shipments to each
other. It is this linkage in records that will allow for efficient
tracing of product during an investigation and assist in any needed
traceforward operations.
    (Comment 371) One comment maintains that it would be difficult for
harvesters or initial buyers of seafood in foreign countries to
determine if they need to comply with the first receiver requirements
of the rule because they may not know the final destination of the
product.
    (Response 371) As noted above, we have deleted the first receiver
requirements, which should alleviate some of the concerns expressed in
the comment. Nevertheless, we understand that under the final rule,
foreign suppliers will still need to know whether their product will be
exported to the United States. Because the rule applies to both
domestic and imported foods on the FTL, importers and other U.S.-based
entities will need to work with their foreign suppliers to ensure that
they understand their responsibilities under subpart S. However,
because many of FDA's existing food safety regulations require
compliance from foreign suppliers, we anticipate that many foreign
suppliers already have mechanisms in place to determine if their foods
will be exported to the United States.
    (Comment 372) Several comments maintain that it is difficult to
understand how the proposed first receiver requirements would apply
under various scenarios where responsibility, ownership, and possession
are not coincidental, such as when contract manufacturing and packing,
consignment, brokerage, third-party logistics warehouses, co-
operatives, or consolidators are involved.
    (Response 372) As previously stated, we have deleted the proposed
requirements for first receivers from the final rule and replaced them
with requirements for the initial packing of a RAC (other than food
obtained from a fishing vessel) (Sec.  1.1330) and the first land-based
receiving of a food obtained from a fishing vessel (Sec.  1.1335).
These requirements are not tied to ownership of the FTL food, which
should reduce the confusion expressed in the comments. Physical
possession of the food and performance of the activity (e.g., initial
packing) are what determines who must comply with Sec. Sec.  1.1330 and
1.1335, as well as with the other CTEs and KDEs in the final rule.
Thus, for example, if a contract manufacturer performed the initial
packing of an FTL food, it would be required to comply with the initial
packing requirements in Sec.  1.1330. Similarly, if a third-party
logistics warehouse received a food after it was initially packed, it
would be subject to Sec.  1.1345 due to its taking physical possession
of the food in receiving it. As discussed in Section V.R of this
document, entities that are subject to the subpart S requirements are
allowed to have another entity (such as the owner of the food)
establish and maintain the required records on their behalf; but it is
the entity that manufactures, process, packs, or holds the food that is
ultimately responsible for compliance, regardless of whether or not
they own the food.
    (Comment 373) One comment maintains that the effort to send certain
KDEs to first receivers will be ineffectual if there is no mechanism
for ensuring accuracy. According to the comment, because the KDEs are
not all related to the immediate previous source of an FTL food, the
first receiver would not be able to verify their accuracy. Some
comments ask who will be held accountable if the data firms receive are
not accurate. The comments maintain that in some cases the first
receiver may not know they are the first receiver, or the shipper may
not identify themselves as a farm, possibly leading to inadvertent non-
compliance. One comment maintains that such a situation may arise
because shipments of the exact same product with different traceability
lot codes could have different first receiver recordkeeping
requirements at the same receiver, depending on the path the foods took
to the receiver.
    (Response 373) As previously stated, we have deleted the proposed
requirements for first receivers from the final rule, which should
alleviate some of the concerns expressed in the comment. We believe it
will be clear which entity in the supply chain is the initial packer or
the first land-based receiver of an FTL food because those entities are
performing specific activities. This is in contrast to the situation
that would have existed under the proposed rule, in which the first
receiver would have had to rely in part on information from their
supplier that the supplier was a farm, which meant that they were the
first receiver of the food.
    More generally, we agree that data accuracy is critical to
effective tracking and tracing of food. This is a principal reason why
the final rule requires harvesters and coolers to provide the
applicable KDEs to the initial packer of a RAC, and why it also
requires shippers to provide the applicable KDEs to receivers. Every
entity that is covered by subpart S is required to accurately maintain
and (when applicable) pass along the required information. Where there
are concerns about data accuracy, we encourage supply chain partners to
work together to address those concerns.
    (Comment 374) One comment states that first receivers may have
challenges in obtaining required first receiver KDEs from ``small
originators'' that are exempt from the rule.
    (Response 374) Although we have removed the first receiver
requirements from the final rule, we recognize that similar concerns
could arise for an initial packer if the harvester and/or cooler that
would usually be required to send required information to the initial
packer is exempt from the rule. Therefore, the initial packing
requirements include a provision specifying the records that initial
packers must keep when they receive a RAC from someone to whom the
subpart S requirements do not apply. Section 1.1330(c) specifies that
for each traceability lot of a RAC (other than a food obtained from a
fishing vessel) on

the FTL that a firm initially packs that it receives from a person to
whom subpart S does not apply, the initial packer must maintain records
containing the following information and linking this information to
the traceability lot:
     The commodity and, if applicable, variety of the food
received (Sec.  1.1330(c)(1));
     The date the initial packer received the food (Sec.
1.1330(c)(2));
     The quantity and unit of measure of the food received
(e.g., 75 bins, 200 pounds) (Sec.  1.1330(c)(3));
     The location description for the person from whom the
initial packer received the food (Sec.  1.1330(c)(4));
     The traceability lot code the initial packer assigns
(Sec.  1.1330(c)(5));
     The product description of the packed food (Sec.
1.1330(c)(6));
     The quantity and unit of measure of the packed food (e.g.,
6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds) (Sec.
1.1330(c)(7));
     The location description for where the food was initially
packed (i.e., the traceability lot code source) and (if applicable) the
traceability lot code source reference (Sec.  1.1330(c)(8));
     The date of initial packing (Sec.  1.1330(c)(9)); and
     The reference document type and reference document number
(Sec.  1.1330(c)(10)).
    We think the information required under Sec.  1.1330(c) is
information that initial packers can be reasonably expected to know in
situations where they receive a RAC from someone who is exempt from
subpart S. Section 1.1330(c) does not require initial packers to
maintain records relating to information they would have needed to rely
on the harvester or cooler to provide, such as the name of the field
from which the food was harvested.
    (Comment 375) One comment requests clarification on how information
will be shared downstream, specifically among firms before the first
receiver if a lot code has not yet been assigned to the food. Some
comments express concern about whether FDA would bring enforcement
actions against first receivers that were not provided a traceability
lot code.
    (Response 375) As previously discussed, the final rule deletes the
first receiver requirements and shifts the requirement to assign a
traceability lot code from the grower of the food to the initial
packer. This should eliminate any concerns about what a first receiver
(or a packer) should do if it receives a food to which a traceability
lot code has not been assigned. Furthermore, as discussed in Section
V.N of this document, we have created modified requirements under the
receiving CTE for any covered entity that receives an FTL food from a
person to whom subpart S does not apply (Sec.  1.1345(b)). In that
circumstance, the receiver of the food must assign a traceability lot
code if one has not already been assigned (Sec.  1.1345(b)(1)).
However, that is the only circumstance under which someone receiving
the food (who is not the initial packer or the first land-based
receiver, and who is not transforming the food) may assign a
traceability lot code to the food. In all other circumstances, a
traceability lot code must be provided by the person who ships the
food, and must be maintained by the person who receives the food. If a
required KDE, such as the traceability lot code, is not provided by the
shipper, we encourage the receiver to address this concern with the
shipper.
    (Comment 376) One comment asserts that retailers will be challenged
to determine if they are the first receiver when they purchase foods
from brokers, because brokers are not covered by the rule and are not
required to provide first receiver KDEs.
    (Response 376) Because we have deleted the proposed first receiver
requirements, we do not believe that RFEs and restaurants that purchase
food from brokers will be challenged in understanding their
recordkeeping responsibilities under subpart S. In most cases, the only
KDEs that an RFE or restaurant will be required to maintain are the
receiving KDEs under Sec.  1.1345. RFEs and restaurants that purchase
foods from brokers will need to work with their suppliers and/or
brokers to ensure they receive the information provided by the shipper
of the food in accordance with Sec.  1.1340(b) (see Section V.N of this
document).
    (Comment 377) One comment suggests that, if FDA retains the first
receiver requirements in the final rule, the Agency should make clear
that covered entities may rely on other parties to establish and
maintain records on their behalf.
    (Response 377) As previously stated, we have deleted the proposed
first receiver requirements. We discussed in the preamble to the
proposed rule that entities subject to the rule may have third parties
maintain records on their behalf. However, to be more explicit in the
final rule that covered entities may do this, we have added language to
specify that a person subject to the rule may have another entity
establish and maintain records required under subpart S on their
behalf, but the person is responsible for ensuring that such records
can be retrieved and provided onsite within 24 hours of request for
official review (see Sec.  1.1455(b)).
    (Comment 378) One comment requests clarification on whether an egg
processing plant that is owned by an egg farmer but not necessarily co-
located with the farm (e.g., it is separated by a few miles) would be
the first receiver of the eggs.
    (Response 378) As previously discussed, we have deleted the
proposed first receiver requirements and have added requirements for
the initial packing of RACs other than food obtained from a fishing
vessel. In the situation described in the comment, it seems likely that
the egg farmer is the harvester of the eggs, and the egg processing
plant is the initial packer. This is based on the activities performed
and does not depend on ownership or location. The final rule provides
flexibility as to how the harvester of the eggs provides the initial
packer with the information on harvesting required under Sec.
1.1325(a)(2). Additionally, as discussed in Response 206, if an egg
processing plant commingles eggs from a farm it owns with eggs from
other farms under different company management, and it does so after
harvesting but before processing, the commingled eggs are partially
exempt from the final rule (see Sec.  1.1305(h)).
2. Additional Records for Initial Packing of Sprouts
    In the proposed rule as part of the growing CTE, we proposed to
require that sprout growers establish and maintain records linking the
traceability lot code for each lot of sprouts to certain information
about the seeds they use for sprouting (proposed Sec.  1.1325(b)).
Specifically, we proposed to require sprout growers to establish and
maintain records containing the following information, if applicable:
    (1) The location identifier and location description of the grower
of seeds for sprouting, the associated seed lot code assigned by the
seed grower, and the date of seed harvesting;
    (2) The location identifier and location description of the seed
conditioner or processor, the associated seed lot code assigned by the
seed conditioner or processor, and the date of conditioning or
processing;
    (3) The location identifier and location description of the seed
packinghouse (including any repackers, if applicable), the associated
seed lot code assigned by the seed packinghouse, and the date of
packing (and of repacking, if applicable);
    (4) The location identifier and location description of the seed
supplier;

    (5) A description of the seeds, including the seed type or
taxonomic name, growing specifications, volume, type of packaging, and
antimicrobial treatment;
    (6) The seed lot code assigned by the seed supplier, including the
master lot and sub-lot codes, and any new seed lot code assigned by the
sprouter;
    (7) The date of receipt of the seeds by the sprouter; and
    (8) For each lot code for seeds received by the sprouter, the
sprout traceability lot code(s) and the date(s) of production
associated with that seed lot code.
    As discussed in the following paragraphs, in response to comments
we have made changes to the requirements for sprout growers and we have
moved these requirements to the CTE for initial packers, so that the
requirements apply to initial packers of sprouts. In addition, on our
own initiative, we have clarified that these requirements for the
initial packers of sprouts do not apply to soil- or substrate-grown
sprouts harvested without their roots, consistent with the types of
sprouts that are subject to subpart M (``Sprouts'') of the produce
safety regulation. In the preamble to the final rule adopting the
produce safety regulation (80 FR 74353 at 74497), we stated that soil-
or substrate-grown sprout shoots that are harvested above the soil or
substrate line, such that their roots are not harvested for human
consumption, do not present the same risks as other types of sprouts.
Therefore, soil- or substrate-grown sprouts that are harvested without
their roots are not covered by the sprout-specific provisions in
subpart M, but are covered by the remainder of the produce safety
regulation. Similarly, we conclude that soil- or substrate-grown
sprouts that are harvested without their roots should not be covered by
the sprout-specific provisions in Sec.  1.1330(b), but they are covered
by the remainder of the requirements in subpart S.
    (Comment 379) One comment requests clarification on who is
responsible for maintaining the proposed records of sprout growing.
Some comments maintain that entities other than the sprout grower would
be better positioned to establish and maintain the required KDEs. For
example, several comments suggest that either the growers of seed for
sprouting, the suppliers of seed for sprouting, or both should be
required to maintain the records. A few comments assert that sprout
growers should only be required to maintain records that trace back to
the seed supplier, contending that the proposed requirements would
place too great a burden on sprout growers by requiring them to have
information to which they might not have access (e.g., information on
seed growers). One comment suggests that the records should be
maintained by the seed grower and seed supplier, as appropriate, and
only be provided to the sprout grower during an investigation of an
outbreak of foodborne illness, citing concerns related to sharing
proprietary business information through the supply chain.
    (Response 379) As discussed above, we have revised the final rule
so that the sprout-specific KDEs are kept by the initial packer of the
sprouts, not the grower. (We recognize that in many cases the grower is
also the initial packer.) We do not agree that entities such as the
seed supplier or seed grower should be required to maintain these KDEs.
Because sprouts are the commodity that is on the FTL, we do not think
it is appropriate to require entities in the supply chain before the
sprouts have been grown (e.g., seed suppliers) to maintain information
under subpart S. However, under Sec.  1.1455(b), an initial packer of
sprouts may arrange for a seed supplier or another entity to maintain
information required by the rule on their behalf, as long as the
initial packer can provide the required information to FDA within 24
hours of a request.
    (Comment 380) Several comments express support for some or all of
the proposed KDEs related to sprouts and seed for sprouting. However,
one comment asserts that the proposed requirements fail to reflect the
complexity of the international supply chain for seeds for sprouting,
especially mung beans. The comment describes challenges associated with
tracing mung beans grown overseas, specifically with obtaining
information such as the location identifier and location description of
the grower of seed for sprouting, the seed lot code assigned by the
seed grower, and the date of seed harvesting. The comment maintains
that tracing to the seed level would prevent importation of
internationally sourced mung beans and suggests revising the provisions
to require traceback of seed lots to the farm level only when such
information is reasonably available and obtainable.
    (Response 380) We agree that some of the proposed recordkeeping
requirements related to seed growers may be challenging for sprout
growers to obtain and we have made changes to the requirements in the
final rule. As previously discussed, we have deleted the proposed
requirements for the growing and first receiver CTEs and have added
requirements for initial packing of RACs other than food obtained from
a fishing vessel that include specific requirements for sprout growers.
Regarding the proposed sprout-specific requirements, we agree with the
comments that it would be challenging for sprout growers (and initial
packers of sprouts) to consistently obtain information related to the
growing and harvesting of seed used for sprouting, particularly in
situations where the seed was sourced from multiple small entities.
Therefore, in Sec.  1.1330(b)(1) we have deleted the requirement to
keep the seed lot code assigned by the seed grower (proposed Sec.
1.1325(b)(1)) and are requiring information related to the location
description for the seed grower and the date of harvesting of the seed
(proposed Sec.  1.1325(b)(1)) only if either is available to the
initial packer of sprouts. We deleted the requirement to maintain
information on the seed lot code assigned by the seed grower because it
might be especially burdensome, as there might be a considerable number
of small farms growing seed for sprouting, which could result in having
to record a large number of seed lot codes for a single shipment of
seeds. However, we encourage initial packers of sprouts to maintain the
seed lot code assigned by the seed grower, if it is available to them.
We have changed the language relating to seed lot codes in final Sec.
1.1330(b)(2) through (4) to better reflect the variation in industry
practices regarding the assignment of seed lot codes. Thus, while
proposed Sec.  1.1325(b)(2) required a record of the seed lot code
assigned by the seed conditioner or processor, final Sec.  1.1330(b)(2)
omits the language ``assigned by the seed conditioner or processor,''
in recognition of the fact that the lot code associated with the
conditioning or processing of the seeds might not have been assigned by
the conditioner/processor. Final Sec.  1.1330(b)(3) and (4) both
contain language about ``any'' seed lot code that may have been
assigned by the packinghouse (Sec.  1.1330(b)(3)), the supplier, or the
sprouter (Sec.  1.1330(b)(4)). This revised language recognizes that
new seed lot codes might not always be assigned by these entities;
however, any new seed lot codes that are assigned must be maintained.
    As previously stated, we are deleting all proposed requirements
regarding location identifier, including in proposed Sec.  1.1325(b)(1)
through (4). We have also removed the requirement to keep information
on volume for the description of the seeds in final

Sec.  1.1330(b)(5) in response to comments asking that we simplify and
streamline the KDEs, and because we determined that this information
was not necessary. We removed the proposed requirement to keep, for
each lot code of seeds received by the sprouter, the sprout
traceability lot code(s) and the date(s) of production associated with
that seed lot code (proposed Sec.  1.1325(b)(8)) because the
information necessary for traceability is captured in the KDEs required
for the initial packer in the final rule. Finally, we added the
requirement to keep reference document type and reference document
number (final Sec.  1.1330(b)(7)) for the sprout-related records for
consistency with the KDEs required for other CTEs in the final rule.
    As a result of these changes, Sec.  1.1330(b) of the final rule
specifies that for each traceability lot of sprouts (except soil- or
substrate-grown sprouts harvested without their roots) that is
initially packed, in addition to maintaining the initial packing KDEs
set forth in Sec.  1.1330(a), the initial packer must also maintain
records containing the following information and linking it to the
traceability lot of sprouts:
     The location description for the grower of seeds for
sprouting and the date of seed harvesting, if either is available
(Sec.  1.1330(b)(1));
     The location description for the seed conditioner or
processor, the associated seed lot code, and the date of conditioning
or processing (Sec.  1.1330(b)(2));
     The location description for the seed packinghouse
(including any repackers), the date of packing (and of repacking, if
applicable), and any associated seed lot code assigned by the seed
packinghouse (Sec.  1.1330(b)(3));
     The location description for the seed supplier, any seed
lot code assigned by the seed supplier (including the master lot and
sub-lot codes), and any new seed lot code assigned by the sprouter
(Sec.  1.1330(b)(4));
     A description of the seeds, including the seed type or
taxonomic name, growing specifications, type of packaging, and (if
applicable) antimicrobial treatment (Sec.  1.1330(b)(5));
     The date of receipt of the seeds by the sprouter (Sec.
1.1330(b)(6)); and
     The reference document type and reference document number
(Sec.  1.1330(b)(7)).
    Other than the deletion of the location identifier KDEs and the
changes regarding seed lot codes, the final requirements related to the
maintenance of information concerning seed conditioning, seed
packinghouses, and seed suppliers are the same as the proposed
requirements. We did not receive comments indicating that this
information would be difficult to obtain for sprout growers and we
continue to believe this information is needed to facilitate the
tracing of seed used for sprouting. The specific food safety concerns
relating to sprouts (including concerns about the seeds used for
sprouting) are discussed in the preamble to the proposed rule (see 85
FR 59984 at 60007).
    (Comment 381) Several comments maintain that there is overlap
between the subpart S requirements and organic certification, and one
comment asserts that current industry best practices cover the proposed
requirements for sprouts.
    (Response 381) As discussed in Response 119, any records that an
organic farm may keep under the National Organic Program (or other
certification program) that contain information required by subpart S,
such as the field where product was harvested or the date of harvest,
can be used to comply with this subpart. Therefore, to the extent that
initial packers of sprouts maintain records for organic certification
(or for any other purpose) that contain information required in Sec.
1.1330 or other applicable subpart S requirements, they may use such
records to meet the requirements of this rule (see Sec.  1.1455(f)).
    (Comment 382) Several comments ask whether the requirement in
proposed Sec.  1.1325(b)(1) refers to the date of seed (for sprouting)
harvest or the date of sprout harvest.
    (Response 382) Proposed Sec.  1.1325(b)(1) referred to the ``date
of seed harvesting,'' by which we meant the date of harvesting of the
seeds used for sprouting. Section 1.1330(b)(1) of the final rule
requires initial packers of sprouts to maintain records including,
among other information, the ``date of seed harvesting,'' if it is
available. This refers to the harvest date for the seeds used for
sprouting, not of the sprouts themselves. Initial packers of sprouts
also must maintain records identifying the harvest date of the sprouts
(Sec.  1.1330(a)(8)).
    (Comment 383) Several comments suggest adding a requirement for
sprout growers to maintain records of seed testing results (e.g., tests
for pathogens, germination, and/or purity).
    (Response 383) We decline to make this change because we conclude
that a requirement for sprout operations to maintain records of seed
testing would be beyond the scope of this rulemaking. Such records
would not improve the efficiency of traceback for sprouts in the event
of an outbreak of foodborne illness, which is the purpose of this
rulemaking. However, we note that there are sprout testing requirements
in subpart M of the produce safety regulation, including a requirement
to establish and keep records documenting the results of all analytical
tests conducted for purposes of compliance with subpart M (see 21 CFR
112.150(b)(4)).
    (Comment 384) One comment disagrees with the statement in the
preamble to the proposed rule that seeds that are primarily intended
for livestock or field cultivation are sometimes diverted for sprouting
for human consumption (see 85 FR 59984 at 60007). The comment maintains
that their firm only sources seed for sprouting from growers that
produce seed specifically for sprouting for human consumption.
    (Response 384) We acknowledge that some sprout growers may use
seeds from growers that produce seed specifically for sprouting for
human consumption, and we support and encourage those efforts. However,
we are aware that the intended use of seed when it is grown (e.g.,
animal consumption or field cultivation) is not always commensurate
with how it is ultimately used (Ref. 28).

L. Records of First Land-Based Receiving of Food Obtained From a
Fishing Vessel (Sec.  1.1335)

    We proposed to require first receivers of seafood products on the
FTL that were obtained from a fishing vessel to keep, in addition to
records of receipt of food required under proposed Sec.  1.1335,
records containing and linking the traceability lot code of the seafood
product received to the harvest date range and locations (National
Marine Fisheries Service Ocean Geographic Code or geographical
coordinates) for the trip during which the seafood was caught (proposed
Sec.  1.1330(b)). Included among the proposed KDEs for receivers of FTL
foods was the location identifier and location description for the
immediate previous source (other than a transporter) of the food
(proposed Sec.  1.1335(a)), which for food obtained from a fishing
vessel meant the vessel identification number or license number (both
if available) for the fishing vessel (under the proposed definition of
``location identifier'') and 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 (under the
proposed definition of ``location description'') (see proposed Sec.
1.1310).

    However, as previously discussed, we are deleting the proposed
first receiver recordkeeping requirements and replacing them with
requirements related to the initial packing of RACs other than food
obtained from a fishing vessel (Sec.  1.1330) and the first land-based
receiving of food obtained from a fishing vessel (Sec.  1.1335). As
previously stated, the final rule defines ``first land-based receiver''
as the person taking possession of a food for the first time on land
directly from a fishing vessel (see Sec.  1.1310). We are also removing
the concept of a ``location identifier'' from the final rule (including
the parts of that term that were specific to fishing vessels), and we
are revising the definition of ``location description'' so that it no
longer includes information specific to fishing vessels.
    Section 1.1335 of the final rule specifies that for each
traceability lot of a food obtained from a fishing vessel for which a
person is the first land-based receiver, such person must maintain
records containing the following information and linking this
information to the traceability lot:
     The traceability lot code they assigned (Sec.  1.1335(a));
     The species and/or acceptable market name for unpackaged
food, or the product description for packaged food (Sec.  1.1335(b));
     The quantity and unit of measure of the food (e.g., 300
kg) (Sec.  1.1335(c));
     The harvest date range and location (as identified under
the National Marine Fisheries Service Ocean Geographic Code, the United
Nations Food and Agriculture Organization Major Fishing Area list, or
any other widely recognized geographical location standard) for the
trip during which the food was caught (Sec.  1.1335(d));
     The location description for the first land-based receiver
(i.e., the traceability lot code source), and (if applicable) the
traceability lot code source reference (Sec.  1.1335(e));
     The date the food was landed (Sec.  1.1335(f)); and
     The reference document type and reference document number
(Sec.  1.1335(g)).
    These records required for first land-based receivers of food
obtained from a fishing vessel are similar to the records that first
receivers of food obtained from a fishing vessel would have been
required to keep under proposed Sec. Sec.  1.1330(b) and 1.1335,
although as discussed below we have removed information that would have
identified specific fishing vessels. In the following paragraphs, we
discuss in more detail the requirements applicable to the first land-
based receivers of foods obtained from a fishing vessel in response to
comments we received on the proposed requirements for first receivers
of food obtained from a fishing vessel.
    (Comment 385) One comment maintains that because the first receiver
in the shrimp industry will likely be the unloading dock or a fish
house, it will be difficult for these entities to meet the requirements
to create and maintain the required first receiver records.
    (Response 385) As previously stated, we have deleted the proposed
first receiver requirements. If the shrimp was obtained from a fishing
vessel, and an unloading dock or fish house is the first entity that
takes possession of the shrimp on land, they would be required to
comply with the requirements for first land-based receivers of food
obtained from a fishing vessel in Sec.  1.1335. We think these entities
will be well-positioned to comply with these requirements. Information
regarding harvest location and harvest date ranges (Sec.  1.1335(d))
will be more readily available to the first land-based receiver because
they are receiving fish directly from the vessels, and the unloading
dock or fish house should readily know the other information required
under Sec.  1.1335, which includes the traceability lot code they must
assign (in accordance with Sec.  1.1320(a)) as the first land-based
receiver of the food (Sec.  1.1335(a)), and the species and/or
acceptable market name for unpackaged food or the product description
for packaged food (Sec.  1.1335(b)). Species name is information often
used to describe seafood, as is the acceptable market name, examples of
which can be found in FDA's ``Guidance for Industry: The Seafood List''
(Ref. 29). The first land-based receiver also must keep a record of the
quantity and unit of measure of the food received (Sec.  1.1335(c)) and
the date the food was landed (Sec.  1.1335(f)), which is the date when
the food is transferred for the first time from a fishing vessel to
land. In addition, the first land-based receiver must keep a record of
its own location description (Sec.  1.1335(e)), which is also the
traceability lot code source (because the first land-based receiver
assigns the traceability lot code to the food), and, if applicable, the
traceability lot code source reference (if the first land-based
receiver elects to provide a traceability lot code source reference to
its customers when it ships the food) (see Sec.  1.1340(b) and Section
V.F of this document). Lastly, the first land-based receiver must keep
a record of the reference document type and number for the reference
document (or documents) associated with their receipt of the food.
    (Comment 386) Several comments agree that the first receiver of
seafood products should be the buyer or the first person (other than a
fishing vessel or aquaculture farm) who purchases and takes physical
possession of a food on the FTL. However, one comment asks that we
allow fishing vessels that process fish and that are registered food
facilities to fulfill the first receiver recordkeeping requirements
because they are best suited to meet these requirements based on their
role in the supply chain. This comment suggests that some companies may
be integrated such that the food remains in their control from harvest
through processing (first and secondary), and the end point of service
may be the first transfer of ownership of the food.
    (Response 386) As discussed above, fishing vessels are exempt from
most of the requirements of subpart S (see Sec.  1.1305(m)), and a
fishing vessel, including one that processes on the vessel, would not
meet the definition of a first land-based receiver. However, a fishing
vessel could establish and maintain the required records on behalf of
the first land-based receiver, in accordance with Sec.  1.1455(b). More
generally, a fishing vessel could assign a lot code to the lot it
processes and provide the lot code and other relevant information
(e.g., harvest date range and location) to the first land-based
receiver to assist that entity in meeting the requirements of Sec.
1.1335. The first land-based receiver would then have the option of
retaining the lot code assigned on the vessel as the traceability lot
code for the food or assigning its own traceability lot code. Under
either option, the first land-based receiver would be the traceability
lot code source for the food.
    Regarding an integrated company such as is described in the
comment, Sec.  1.1305(m)(1) specifies that (except as stated in Sec.
1.1305(m)(2)) subpart S does not apply to entities that manufacture,
process, pack, or hold food obtained from a fishing vessel until such
time as the food is sold by the owner, operator, or agent in charge of
the fishing vessel. Thus, in a situation where the owner, operator, or
agent in charge of the fishing vessel retains ownership of the food
obtained from the fishing vessel after the food is received on land,
the partial exemption in Sec.  1.1305(m) would continue to apply even
though the food is now on land. As discussed in Response 225, this may
lead to situations where the first land-based receiver is partially
exempt under Sec.  1.1305(m), and where a traceability lot code is
therefore not required until the food is sold to a non-exempt receiver,

who would be required to assign a traceability lot code under Sec.
1.1345(b)(1) (unless they are an RFE or restaurant). Similar to the
discussion above, an integrated company of this sort could assign lot
codes to the food it handles and could provide those lot codes and
other relevant traceability information to the first non-exempt
receiver to assist that entity in meeting the requirements of Sec.
1.1345(b). More generally, we recognize that many integrated companies
of this sort are adopting practices to improve traceability, and we
encourage such efforts even in situations where a company's activities
are partially exempt under Sec.  1.1305(m).
    (Comment 387) One comment asserts that for molluscan shellfish, the
permitted dealer who makes the first purchase of the shellfish should
be considered the first receiver under the rule. The comment maintains
that if the permitted dealer is a harvester or aquaculture farmer, they
would become the first receiver once the product is landed and taken to
a land-based facility for processing and sale.
    (Response 387) If the permitted dealer described in the comment
meets the definition of the first land-based receiver of the shellfish
(i.e., it is the person taking possession of the food for the first
time on land directly from the fishing vessel), that permitted dealer
would be responsible for maintaining the relevant KDEs for the
shellfish in accordance with Sec.  1.1335. However, we note that raw
bivalve molluscan shellfish that meets the criteria in Sec.  1.1305(f)
is exempt from the rule.
    (Comment 388) One comment states that transshipment of fish between
vessels of different ownership is a common business practice in the
seafood industry that increases the efficiency of fishing fleets, but
may also be used to conceal illegal, unreported, and unregulated (IUU)
catch. The comment asserts that, to combat IUU catch, many seafood
industry leaders and retailers have published at-sea transshipment
policies that require data collection on the occurrence of
transshipment. The comment recommends that the first receiver KDEs
include vessel identification numbers of both harvesting and
transshipment vessels and dates of harvest and transshipment. The
comment also suggests that mass balance recalculations be required at
each CTE for the fish (i.e., accounting for the amount of fish before
and after the event, including transformation of fish into another form
(e.g., processing) and movement of fish out of a person's control
(e.g., transfer to another boat)).
    (Response 388) As previously discussed, for food obtained from a
fishing vessel, we have replaced the proposed first receiver
requirements with the first land-based receiver requirements in Sec.
1.1335. The KDEs for first land-based receivers include information on
the harvest location and harvest date range for the food obtained from
a fishing vessel (Sec.  1.1335(d)). However, we have deleted the
proposed requirements to maintain information identifying the fishing
vessel, whether a landing or transshipment vessel. Specifically, we
have deleted the proposed requirements for first receivers of food
obtained from fishing vessels to maintain the ordinary records of
receipt of foods (see proposed Sec.  1.1330(b)), including the location
identifier and location description for the immediate previous source
(other than a transporter) of the food (proposed Sec.  1.1335(a)),
which, under the definitions set forth in proposed Sec.  1.1310, would
have included the name of the fishing vessel that caught the seafood,
the vessel identification number or license number (both if available)
for the fishing vessel, the country in which the fishing vessel's
license (if any) was issued, and a point of contact for the fishing
vessel. We conclude that it is not necessary to require first land-
based receivers to maintain information identifying the fishing vessel
because that is generally not information we need to identify
contaminated food during a traceback, and it is unlikely we would go to
a fishing vessel during an investigation of foodborne illness.
Moreover, we decline to adopt fishing vessel identification
requirements to facilitate identification of IUU fishing because that
concern is beyond the scope of subpart S, which is intended to assist
with traceback and traceforward operations in response to foodborne
illness outbreaks. However, we support efforts to combat IUU fishing
practices, including efforts to maintain records beyond those required
under subpart S that might provide additional information on the
movement of seafood and seafood products.
    Regarding the request that we require mass balance calculations for
fish at each CTE, the final rule requires the first land-based receiver
to maintain a record of the quantity and unit of measure of food
obtained from a fishing vessel (Sec.  1.1335(c)). Quantity and unit of
measure are also required as part of the shipping, receiving, and
transformation KDEs. However, we cannot require fishing vessels to keep
information on the amount of fish that is transferred among vessels at
sea, as fishing vessels are largely exempt from the subpart S
requirements under Sec.  1.1305(m).
    (Comment 389) One comment recommends that a transshipment vessel
capture first receiver KDEs, rather than designating the first receiver
as the first person other than a fishing vessel or farm to take
possession of the food. The comment maintains that some seafood
products have long journeys before being landed with a first receiver,
during which the seafood must be kept at a proper temperature to
maintain freshness and prevent foodborne illness. Therefore, the
comment suggests that first receivers be required to keep a record of
the first frozen date and location and the packing date and location.
    (Response 389) Because section 204(d)(6)(C) of FSMA (codified in
Sec.  1.1305(m) of the final rule) partially exempts owners, operators,
and agents in charge of a fishing vessel from the subpart S
recordkeeping requirements, we cannot require that operators of fishing
vessels maintain the suggested KDEs. However, the rule requires the
first land-based receivers of food obtained from a fishing vessel to
maintain certain KDEs, including information on the harvest date range
and harvest location of the food, the description of the food, and the
quantity and unit of measure of the food, which could include
information on whether the product was frozen and how it was packed.
First land-based receivers are not required to record the dates of any
freezing or packing of the food on the fishing vessel. However,
information on any processing that occurs on vessels may need to be
kept for compliance with other FDA regulations, such as the seafood
HACCP regulation in part 123.
    (Comment 390) Some comments express concern that harvesters and
initial buyers might be unlikely to know the final destination or
market form of the fish they capture or purchase. The comments request
additional information on how the rule would apply in this situation.
    (Response 390) As previously stated, the final rule requires that
first land-based receivers of food obtained from a fishing vessel
maintain certain KDEs about the food as it was caught (e.g., harvest
date range and harvest location) and information on the food as it was
handled by them (e.g., the quantity and unit of measure of the food,
the date of landing). It is not necessary for entities such as
harvesters and initial buyers to know the final destination or market
form of the food to maintain the KDEs for which they are responsible.
However, if such firms know that the

food they harvest or buy will eventually be subjected to a kill step or
changed such that it is no longer on the FTL, they may be eligible for
an exemption under Sec.  1.1305(d)(6) of the final rule if they enter
into a written agreement specifying that a kill step will be applied or
the food will be changed such that it is no longer on the FTL.
Similarly, if the seafood is a RAC and they know that it will be
commingled after it is harvested but before it is processed, they may
be eligible for an exemption under Sec.  1.1305(h)(2), if they enter
into a written agreement as set forth in that provision.
    (Comment 391) One comment recommends separately listing first
receiver KDEs required for aquacultured products and seafood products
from a fishing vessel to make the rule easier to understand. The
comment also suggests specifying that the KDEs for harvesting and
packing be considered ``as applicable'' because some may not apply to
aquaculture.
    (Response 391) We agree that the requirements for food from
aquaculture farms and food obtained from fishing vessels should be
listed separately. As previously stated, the final rule deletes the
proposed first receiver requirements and replaces them with
requirements applicable to the initial packing of RACs other than food
obtained from a fishing vessel, which includes food from aquaculture
farms (see Sec.  1.1330(a)(6)), and requirements for the first land-
based receiving of food obtained from a fishing vessel (Sec.  1.1335).
Under Sec.  1.1330(a), the initial packer of aquacultured food must
keep information on the harvesting and packing (among other things) of
food from aquaculture farms. We believe that all of the information
required under Sec.  1.1330(a) is relevant to aquaculture (see Response
122 for a discussion of initial packing of aquacultured food).
    (Comment 392) One comment suggests that ``location identifier'' be
an optional requirement because most organizations do not assign
``identifiers'' to locations that are referenced by their organization
and their customers. The comment maintains that the proposed rule's
reference to a fishing vessel as a ``location'' is confusing because of
the artificial distinction between an identifier and a description.
Another comment suggests that maintaining the location identifier and
location description for a fishing vessel should only be required if
there are hazards associated with the harvest location. Both comments
ask why fishing vessels are the only location descriptions that require
a point of contact. One comment also recommends that the location
description for fishing vessels be any of the applicable proposed
attributes, including vessel identification number, license number,
name of the vessel, or the country in which the vessel is licensed.
    (Response 392) We agree with the comment that requiring both a
location identifier and location description would be confusing for
organizations that do not assign identifiers to locations or for
locations with multiple location identifiers. Therefore, we have
deleted the proposed definition for ``location identifier'' along with
all proposed requirements to keep a record of the location identifier.
With respect to fishing vessels, we have deleted the proposed
definition of ``location description'' as specifically applicable to
fishing vessels (i.e., 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), and we have
deleted all proposed requirements to record fishing vessel
identification information. Instead, the rule requires the first land-
based receiver of food obtained from a fishing vessel to maintain
records linking the traceability lot to the harvest date range and
locations (as identified under the National Marine Fisheries Service
Ocean Geographic Code, the United Nations Food and Agriculture
Organization Major Fishing Area list, or any other widely recognized
geographical location standard) for the trip during which the food was
caught. The first land-based receiver must maintain this information
regardless of whether the relevant fishing waters are associated with
known hazards.
    (Comment 393) Several comments state that seafood catches from
multiple fishing vessels are commingled at various points in the supply
chain, including while at sea, immediately following landing before
receipt by a first receiver, or both. The comments assert that it will
be challenging to maintain traceability information on the catches
given the commingling opportunities, and they contend that it would be
impossible to separate the catches from each other once they are
commingled.
    (Response 393) As discussed in Section V.E.14 of this document,
fishing vessels are largely exempt from the requirements of this rule
(see Sec.  1.1305(m)). The first land-based receiver of food obtained
from a fishing vessel is required to designate a traceability lot (or
multiple traceability lots) of food obtained from the fishing vessel
and assign a traceability lot code or codes to each traceability lot
(Sec. Sec.  1.1320(a) and 1.1335). Among other KDEs, the first land-
based receiver must keep harvest information (location and date range)
for each traceability lot. However, multiple harvest dates can be kept
as a date range representing the entire catch on a vessel, rather than
lists of dates of each catch. Similarly, multiple harvest locations can
be kept as a single, larger harvest location, encompassing all of the
locations of multiple catches. Thus, the rule does not require a vessel
that has multiple catches to keep the fish separate or maintain
information on dates or locations that is linked to a specific subset
of fish on the vessel (i.e., there is no need to identify a date or
location a given fish was caught if the vessel contains fish harvested
over multiple dates at multiple locations). Finally, we note that there
is a partial exemption from subpart S for commingled RACs (Sec.
1.1305(h)), which for food obtained from a fishing vessel means that
food from different landing vessels was combined or mixed after the
vessels landed but before processing (see the definition of
``commingled raw agricultural commodity'' in Sec.  1.1310).
    (Comment 394) Some comments assert that the harvest location for a
fishing vessel trip should not be restricted to the National Marine
Fisheries Service Ocean Geographic Code or geographical coordinates (as
specified in proposed Sec.  1.1330(b)). The comments maintain that
there are other methods used in the industry to identify harvest
location, including Food and Agriculture Organization Fishing Areas or
approved harvest areas used under the NSSP (which requires an area
identifier code maintained by each state).
    (Response 394) We agree with the comments that other standards may
be used to identify the harvest location for a fishing vessel trip.
Section 1.1335(d) specifies that the harvest location for food obtained
from a fishing vessel may be identified under the National Marine
Fisheries Service Ocean Geographic Code, the United Nations Food and
Agriculture Organization Major Fishing Area list, or any other widely
recognized geographical location standard. With regard to the NSSP, we
note that raw bivalve molluscan shellfish that are covered by the
requirements of the NSSP are exempt from subpart S, as are all raw
bivalve molluscan shellfish that meet the criteria in Sec.  1.1305(f).
    (Comment 395) One comment states that the location identifier,
location description, and point of contact for the traceability lot
code generator, which shippers of shellfish would be required

to keep under proposed Sec.  1.1350(a)(4), are all contained in the
State Shellfish Control Authority Dealer permit, which uses the
standards outlined by the NSSP to certify shellfish dealers to ship or
process shellfish for shipment. The comment recommends that for raw
bivalve molluscan shellfish covered by the requirements of the NSSP,
the shellfish dealer should be regarded as the first receiver of the
shellfish and the traceability lot code generator. The comment asserts
that because FDA's Interstate Certified Shellfish Shippers List (ICSSL)
already has the location and point of contact information for the
shellfish dealer, a simple reference code containing the state, dealer
type, and dealer number is all that would be needed to access the
traceability lot code generator information for the first receiver.
    (Response 395) We agree that the NSSP requires robust traceability
information for raw bivalve molluscan shellfish. We also understand
that each Authority will certify shellfish facilities and subsequently
request that FDA list them on the ICSSL via the form FDA 3038. This
form does contain the dealer's name and a contact name and address. As
previously stated, the final rule exempts from subpart S raw bivalve
molluscan shellfish that is covered by the requirements of the NSSP
(see Sec.  1.1305(f)).

M. Records of Shipping (Sec.  1.1340)

    We proposed to require that for each food on the FTL that is
shipped, the shipper must establish and maintain records containing and
linking the traceability lot code of the food to the following
information: the entry number(s) assigned to the food (if the food is
imported) (proposed Sec.  1.1350(a)(1)); the quantity and unit of
measure of the food (e.g., 6 cases, 25 returnable plastic containers,
100 tanks, 200 pounds) (proposed Sec.  1.1350(a)(2)); the traceability
product identifier and traceability product description for the food
(proposed Sec.  1.1350(a)(3)); the location identifier, location
description, and point of contact for the traceability lot code
generator (proposed Sec.  1.1350(a)(4)); the location identifier and
location description for the immediate subsequent recipient (other than
a transporter) of the food (proposed Sec.  1.1350(a)(5)); the location
identifier and location description for the location from which the
food was shipped, and the date and time the food was shipped (proposed
Sec.  1.1350(a)(6)); the reference record type(s) and reference record
number(s) (e.g., ``BOL No. 123,'' ``ASN 10212025'') for the document(s)
containing the previously stated information (proposed Sec.
1.1350(a)(7)); and the name of the transporter who transported the food
from the shipper (proposed Sec.  1.1350(a)(8)). As discussed below, in
response to comments as well as on our own initiative (to align the
shipping KDEs with other changes we are making to the proposed rule),
we have deleted some of the proposed shipping KDEs and have revised
others.
    In addition to the records that shippers of FTL foods must
maintain, we proposed to require shippers to send records (in
electronic or other written form) containing the information the
shipper was required to keep (except for the information on reference
record types and numbers) to the immediate subsequent recipient (other
than a transporter) of each traceability lot shipped (proposed Sec.
1.1350(b)(1)). We further proposed to require that farms must also send
the following information to the recipient: a statement that the entity
is a farm; the location identifier and location description of the
originator of the food (if not the farm providing this information);
the business name, point of contact, and phone number of the harvester
of the food (if not the farm providing this information), and the
date(s) and time(s) of harvesting; the location identifier and location
description of the place where the food was cooled (if not the farm
providing this information), and the date and time of cooling; and the
location identifier and location description of the place where the
food was packed (if not by the farm providing this information), and
the date and time of packing (proposed Sec.  1.1350(b)(2)). As
discussed below, we have maintained the proposed requirement specifying
that for most of the KDEs that a shipper must maintain, they must also
send that information to the recipient of the food; however, we have
deleted the proposed requirement for farms to send additional, farm-
related information to the recipient.
    Finally, we have added a provision to the shipping CTE requirements
to specify that these requirements do not apply to any shipment of food
that occurs before the food is initially packed (if the food is a RAC
not obtained from a fishing vessel). This change means that the
recordkeeping requirements for shippers do not apply to farms (or other
entities) that perform activities such as growing, harvesting, or
cooling before a RAC is initially packed (unless the entity is also the
initial packer, in which case it must keep records regarding the
shipping of the packed food). Because fishing vessels are exempt under
Sec.  1.1305(m) from most of the subpart S requirements, including the
shipping CTEs, we did not think it was necessary to add a parallel
provision stating that the shipping requirements under Sec.  1.1340 do
not apply to the shipment of food that occurs before the first land-
based receiving of food obtained from a fishing vessel.
1. Records of Shipment That Must Be Maintained
    (Comment 396) One comment asks for clarification of the ``name of
the transporter'' and whether that refers to a broker, a transport
company, or the driver of the vehicle.
    (Response 396) By the ``name of the transporter,'' we meant the
name of the transport company that transported the food. However, we
have deleted the proposed requirements for shippers and receivers to
maintain a record of the name of the transporter.
    In addition to this deletion to the proposed requirements for
shipping, we also made the following changes:
     We moved the reference to the traceability lot codes from
the ``introductory'' paragraph (proposed Sec.  1.1350(a)) to the
listing of required KDEs;
     We deleted requirements related to the entry number
assigned to imported food (as discussed below);
     We changed ``returnable plastic containers'' to ``reusable
plastic containers'' (as discussed in Response 357);
     We deleted requirements concerning product identifiers and
location identifiers (as discussed in Section V.F of this document);
     We deleted the requirement to record the time of shipment
(as discussed in Response 366);
     We replaced the term ``traceability lot code generator''
with ``traceability lot code source,'' and we are allowing entities to
provide to their customers a traceability lot code source reference
instead of the location description for the traceability lot code
source (as discussed in Section V.F of this document); and
     We changed ``reference record type(s)'' and ``reference
record number(s)'' to ``reference document type'' and ``reference
document number'' (as discussed in Section V.F of this document). (We
note that 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). However, having or
using more than one

of such items is permissible; for example, a firm might use two
different reference documents (with different numbers) to maintain the
KDEs required for shipment of an FTL food, or a firm might have
multiple points of contact who are tasked with traceability
responsibilities.)
    As a result, Sec.  1.1340(a) of the final rule specifies that for
each traceability lot of a food on the FTL that an entity ships, the
entity must maintain records containing the following information and
linking this information to the traceability lot:
     The traceability lot code for the food (Sec.
1.1340(a)(1));
     The quantity and unit of measure of the food (e.g., 6
cases, 25 reusable plastic containers, 100 tanks, 200 pounds) (Sec.
1.1340(a)(2));
     The product description for the food (Sec.  1.1340(a)(3));
     The location description for the immediate subsequent
recipient (other than a transporter) of the food (Sec.  1.1340(a)(4));
     The location description for the location from which the
food was shipped (Sec.  1.1340(a)(5));
     The date the food was shipped (Sec.  1.1340(a)(6));
     The location description for the traceability lot code
source or the traceability lot code source reference (Sec.
1.1340(a)(7)); and
     The reference document type and reference document number
(Sec.  1.1340(a)(8)).
    (Comment 397) Some comments suggest that we eliminate the proposed
requirement for persons who ship a food on the FTL to establish and
maintain records containing and linking the traceability lot code for
the food to the entry number assigned to the food if the food is
imported. One comment suggests that we make the requirement to maintain
the entry number optional. Some comments assert that the entry numbers
for food imports are irrelevant to the question of food traceability
and that maintaining import entry numbers for FTL foods would be
duplicative and unnecessary.
    (Response 397) We agree that it is not necessary to require
shippers to keep records of the entry numbers for imported foods.
Therefore, we have deleted this proposed requirement from the shipping
KDEs.
    (Comment 398) Some comments suggest that requiring shippers and
receivers to keep information on the traceability lot code generator is
inconsistent with FSMA section 204(d)(1)(L)(i)'s prohibition against
requiring a full pedigree because this information represents the point
of origin of the food. One comment expresses concern about the extent
of the responsibility of an entity to maintain information about
previous CTEs associated with an FTL food they manufacture, process,
pack, or hold. The comment urges us to make clear that companies do not
have to maintain records for CTEs that occurred several steps back in
the supply chain (which the comment refers to as a ``product
pedigree'').
    (Response 398) The final rule does not require a full pedigree or a
record of the complete previous distribution history of the food from
the point of origin of such food. Under Sec.  1.1340(a)(7) and (b), the
shipper of an FTL food must keep and provide to its customer the
location description for the traceability lot code source or the
traceability lot code source reference, which provides a means of
identifying and locating the person who assigned the traceability lot
code to the food. However, maintaining a record of the traceability lot
code source or source reference is not the same as maintaining a full
pedigree of the food, or a record of the complete previous distribution
history of the food from the point of origin of such food. The
traceability lot code source is just one part of a food's distribution
history, and for most foods there will be other elements of the
distribution history for which the shipper and receiver of the food
will not be required to maintain records.
    (Comment 399) One comment recommends that phone numbers for
traceability lot code generators not be required.
    (Response 399) We decline this request. Among the required KDEs for
shipping (and other CTEs) is the location description for the
traceability lot code source, which includes the phone number for the
place where the traceability lot code was assigned to the food. We
believe that the phone number for the traceability lot code source is a
critical piece of information during an outbreak investigation or
recall event because it enables FDA to communicate directly with the
entity that assigned the traceability lot code to the food. As
previously stated, a firm may keep and provide to customers a
traceability lot code source reference instead of the location
description for the traceability lot code source. A traceability lot
code source reference will enable FDA to have access to the phone
number and other key contact information for the traceability lot code
source.
    (Comment 400) One comment asserts that the proposed rule is
inconsistent with section 204(d)(1)(E) of FSMA (which specifies, in
part, that the rule may not require the creation and maintenance of
duplicate records where the information is contained in other company
records kept in the normal course of business) because the proposed
requirement to maintain the reference record type and number would
require duplication of existing records, such as invoices.
    (Response 400) We do not agree. We realize that the proposed
requirements for covered entities to maintain the reference record type
and reference record number for certain CTEs could have been
interpreted as requiring duplicative records, but this is not our
intent. As discussed in Section V.F of this document, we are deleting
the terms ``reference record'' and ``reference record number'' from the
rule and adding definitions of ``reference document'' and ``reference
document number.'' Because they are KDEs for certain CTEs, firms would
have to list the applicable reference document types and corresponding
reference document numbers in any electronic sortable spreadsheet they
might provide to FDA in accordance with Sec.  1.1455(c)(3)(ii) (see
Section V.R of this document) to indicate the specific reference
documents that contain the information included in the spreadsheet. For
the CTEs, such as shipping, where this information is required,
maintaining the reference document type and number does not require
creation of a duplicate record because firms may rely on the reference
document itself, such as a BOL, invoice, or ASN, to meet the
requirement to keep a record of the reference document type and number.
For example, if an invoice created by a shipper contains some of the
information required under Sec.  1.1340, such as the date the food was
shipped, the product description for the food, the quantity and unit of
measure of the shipped food, and the traceability lot code for the
shipped food, that invoice (which bears the corresponding invoice
number) can itself serve to document the reference document type and
reference document number. The shipper could also use another reference
document, such as a BOL or PO, as a record for the remaining required
shipping KDEs. (By also including the traceability lot code of the
shipped product on this document, a linkage would be established
between this document and the invoice that contains the other required
KDEs for the same traceability lot.) If the firm's practice, as
described in its traceability plan, is to retain these reference
documents (i.e., the invoice and the BOL or PO) as a means of complying
with Sec.  1.1340(a), then the documents themselves--each

of which presumably bears the relevant document number--would serve to
satisfy Sec.  1.1340(a)(8). If a firm's practice, as described in its
traceability plan, is to comply with subpart S without retaining
specific business documents such as invoices and BOLs--for example, if
a firm instead maintains a master database of all of the required KDEs,
rather than relying on the related business documents--then the
relevant portion (e.g., page, spreadsheet) of the database itself would
be the reference document, and any sortable spreadsheet that might be
requested under Sec.  1.1455(c)(3)(ii) could list the database entry
number, spreadsheet number, etc., as the relevant reference document
type or number.
    Consequently, the requirements to keep records of reference
document types and reference document numbers do not necessitate
maintenance of duplicate records. Existing records, such as invoices
and BOLs with document numbers, or databases with spreadsheet numbers,
can be maintained to meet the requirements of Sec.  1.1340(a)(8) and
can be listed as the applicable reference document types and numbers
(e.g., ``invoice 7534,'' ``BOL 227534,'' ``shipping spreadsheet 127'')
in an electronic sortable spreadsheet that may be provided to FDA in
accordance with Sec.  1.1455(c)(3)(ii). Note that under Sec.
1.1455(a)(1), records (including reference documents) can be kept as
original paper or electronic records or as true copies (such as
photocopies, pictures, scanned copies, or other accurate reproductions
of the original records).
    (Comment 401) One comment maintains that the most important
information to link to the lot code is the firm that originated the
product and the date when the product was produced. The comment cites
feasibility studies that identified these pieces of information as most
essential for traceability. The comment further maintains that lot
codes should be linked to a firm's underlying records so that
additional information can be provided for root-cause analysis, if
necessary.
    (Response 401) We agree with the importance of linking a food's
traceability lot code to information identifying the traceability lot
code source, which is why this information is required under several of
the CTEs, including the shipping CTE. We also agree that date of
production is an important KDE, as reflected in Sec.  1.1330(a)(15)
(date of initial packing) and Sec.  1.1350(a)(2)(iii) (date
transformation was completed). We also think that other information
about the food and its movement through the supply chain--such as the
quantity and unit of measure of the food, the product description of
the food, and the location description of the immediate subsequent
recipient--is important not only for root-cause analysis, but also for
traceability, which is why the final rule requires shippers and others
to maintain this information. We agree that linkage of traceability lot
codes to a firm's reference documents is a useful way to organize and
maintain the relevant information.
    (Comment 402) One comment maintains that for the purpose of
traceability, the product identifier and brand owner information, along
with the lot code, would be more efficient KDEs than the lot code
originator. The comment asserts that the lot code originator may not be
with the same company or may not be authorized to speak to regulators.
One comment maintains that the point of contact should be the person
authorized to speak to regulators.
    (Response 402) The phrase ``lot code originator'' did not appear in
the proposed rule, but as discussed in Section V.F of this document, we
have replaced the term ``traceability lot code generator'' with the
term ``traceability lot code source'' because we believe that the focus
for traceability should be on the place where the lot code was
assigned, rather than the specific individual or entity who assigned
the code. We recognize that the traceability lot code source might not
be the brand owner. We think that information regarding the location
where the traceability lot code was assigned (which is generally the
location where the food was initially packed, first received on land,
or transformed) is more important for traceability than the name of the
brand owner, because the goal of traceability is to follow the physical
movement of the food through the supply chain. During outbreak
situations, information about the traceability lot code source will
allow FDA to more quickly identify key locations and prioritize where
we need to collect tracing data, which in turn will help us more
quickly identify the origin of contaminated foods. Therefore, the rule
requires firms to keep a record of the location description for the
traceability lot code source (or the traceability lot code source
reference, which is an alternative method for providing FDA with access
to that information). The location description includes 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.
    However, we agree that it is also very important during outbreak
investigations that firms make someone available to FDA who is
knowledgeable about the firm's traceability operations. Therefore, a
firm's traceability plan must include a statement identifying a point
of contact for questions regarding the plan and associated records
(Sec.  1.1315(a)(4)). During a traceback investigation, when we contact
the traceability lot code source (by using the location description or
the traceability lot code source reference that shippers and others are
required to maintain), we expect the person we reach to be able to
access the firm's traceability plan and put us in touch with the point
of contact listed in the plan. The rule defines ``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
(Sec.  1.1310). Speaking to this point of contact will allow us to
conduct a more efficient investigation, and we expect the point of
contact to be a person who is authorized to speak to FDA. A firm may
choose to designate another person to speak with us during other
discussions regarding an outbreak investigation or recall; however, for
questions regarding traceability, speaking with the person most
knowledgeable to assist in understanding the firm's internal tracing
system will result in a more efficient investigation.
2. Information the Shipper Must Provide
    (Comment 403) Some comments request clarity on the format in which
records can be sent (such as by sending a link to the required
information electronically), especially as it pertains to electronic
recordkeeping. Some comments specifically ask whether sending a link to
the information required to be sent by the shipper to the subsequent
recipient under proposed Sec.  1.1350(b) is sufficient. The comments
recommend focusing on the outcome (that the information reaches the RFE
or other point at the end of the supply chain) rather than how and by
whom information is shared within the food supply chain. As an
alternative, the comments also suggest that information could be shared
through a central repository where the information is uploaded.
    (Response 403) We recognize that the industry uses numerous means,
both paper-based and electronic, to share information between supply
chain partners. The rule does not prescribe the manner in which
shippers may meet the

requirement in Sec.  1.1340(b) to send information to the immediate
subsequent recipient. Sections 1.1325(a)(2) and (b)(2) and 1.1340(b)
specify that persons may provide information to other entities in the
supply chain in electronic, paper, or other written form. We have also
added language to Sec.  1.1455(a)(1), specifying that electronic
records may include valid, working electronic links to the information
required to be maintained under subpart S. Therefore, a shipper may
provide the required information to the recipient by providing an
electronic link through which the information can be obtained. A firm
also could use a central data repository to provide the required
information as long as the recipient was able to access the information
through the repository. However, for purposes of tracing the product
through the supply chain, we think it is important that the information
somehow be provided to the immediate subsequent recipient of the food,
as opposed to focusing solely on ensuring that the information reaches
the end of the supply chain.
    (Comment 404) One comment maintains that a reference record is not
the only method for communicating the traceability lot code and
associated KDEs, and requests flexibility on when to use reference
records and how to maintain and provide KDEs. Some comments generally
support adding traceability lot codes to invoices, BOLs, ASNs, or other
bill of sale documentation, while one comment expresses concern about
this being a requirement.
    (Response 404) We agree there are multiple ways to communicate the
traceability lot code and associated KDEs between shippers and
receivers, and we have provided flexibility to do so in the final rule.
The rule does not require firms to put traceability lot codes on
documents such as BOLs or ASNs when shipping an FTL food. Covered
entities may prefer to use other methods for documenting and providing
the traceability lot code for a food, and for ensuring that all of the
relevant KDEs are linked to the specific traceability lot. However, we
believe that in most cases, including the traceability lot code on
reference documents for FTL foods will be a useful practice to help
ensure adequate traceability for that food.
    (Comment 405) One comment asserts that location identifiers and
descriptions of the places where the food was cooled and packed should
not be sent to the immediate subsequent recipient, although the comment
does support sending the packing date. The comment maintains that
cooling may happen more than once at multiple locations and that
cooling information is maintained by the cooler, not the farm, and is
typically not provided as the product is moved.
    (Response 405) In the final rule, we have deleted the requirements
in proposed Sec.  1.1350(b)(2) for farms to send information on the
originating, harvesting, cooling, and packing of the food for FTL foods
they ship. We also note that the requirements for shippers of FTL foods
in Sec.  1.1340 of the final rule do not apply to harvesters or to
entities that cool food before it is initially packed (see Response 414
below). However, we do not agree that cooling and packing locations are
not critical for traceability. Therefore, entities that harvest, cool,
or initially pack FTL foods must maintain information on the harvest
location, cooling location, and packing location in accordance with
Sec. Sec.  1.1325 and 1.1330 (as applicable), and harvesters and
coolers are required to send information on their activities to the
initial packer of the food in accordance with Sec.  1.1325(a)(2) and
(b)(2), respectively.
    (Comment 406) Some comments ask why shippers should provide
information to the subsequent recipient, including the location
identifier and description of the subsequent recipient.
    (Response 406) As discussed in the preamble to the proposed rule
(85 FR 59984 at 60012), requiring shippers of food to send certain
information on the foods and the entities that have handled it is
essential for ensuring traceability of the foods throughout the supply
chain, particularly because under current business practices, firms do
not always provide this information to their customers in a way that
can easily be linked for traceability purposes. Therefore, Sec.
1.1340(b) of the final rule requires covered entities who ship FTL
foods to provide certain information in electronic, paper, or other
written form to the immediate subsequent recipient of the food.
    We recognize that it may seem unnecessary for shippers to provide
receivers with information that the receiver is already aware of, such
as the receiver's own location description (as discussed in Response
267, we have removed the requirements relating to location identifier).
However, we have concluded that requiring shippers to send this
information will promote more efficient traceback because it will
ensure that the information is kept in the same way by both the shipper
and the receiver, which will make it easier to link the information
during a traceback. Furthermore, this approach reduces the burden on
receivers because the required information will have already been
provided to them in a format that aligns with the receiver's own
subpart S requirements under Sec.  1.1345. Because shippers will be
required to maintain this information under Sec.  1.1340(a)--and
because many shippers already communicate much of this information in
the course of their regular business practices, though not necessarily
in a format that aligns with subpart S or that can easily be linked
with the receiver's own records--we think that shippers will be well-
positioned to provide this information to the receiver.
    (Comment 407) One comment maintains that a responsible entity
should only have to pass forward certain data, such as a lot code or
GTIN, while other data (such as the case-level GTIN of the originator)
could just be maintained.