use a movement document or any other type of document as a reference
document under the rule.
    (Comment 281) One comment states that the proposed definition of
``reference record'' may preclude commonly used data exchange standards
from GS1, including the Global Data Synchronization Network (GDSN),
Electronic Product Code Information Services (EPCIS), and Electronic
Data Interchange (EDI). The comment asserts in this regard that section
204(d) of FSMA requires FDA to adopt approaches that are
``practicable'' and ``reasonably available and appropriate.''
    (Response 281) We do not agree that the definition of ``reference
document'' (previously ``reference record'') precludes the use of GS1-
related documents as reference documents. As previously stated, the
definition's listing of types of documents that can serve as reference
documents is not exhaustive. Moreover, in changing from the term
``reference record'' to ``reference document,'' we have revised the
definition to make clear that a reference document may be a business
transaction document, record, or message, and may be in electronic or
paper form; the definition also specifies that a person subject to the
rule may establish a reference document or use one that has been
provided to them by someone else. As discussed in Section V.R of this
document, the final rule neither prescribes nor excludes the use of
specific technologies for maintaining required records or providing
required information to subsequent recipients.
36. Reference Record Number
    We proposed to define ``reference record number'' as the
identification number assigned to a reference record, such as a PO
number, BOL number, or work order number. We received no comments on
the definition but have replaced the term ``reference record number''
with ``reference document number'' in the final rule, and have revised
the definition as described above.
37. Restaurant
    We are adding a definition of ``restaurant'' as it is defined in
the food facility registration regulation (Sec.  1.227). The definition
states that ``restaurant'' means a facility that prepares and sells
food directly to consumers for immediate consumption. The definition
further states that ``restaurant'' does not include facilities that
provide food to interstate conveyances, central kitchens, and other
similar facilities that do not prepare and serve food directly to
consumers. The definition also specifies that the following are
restaurants: (1) entities in which food is provided to humans, such as
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food
stands, saloons, taverns, bars, lounges, catering facilities, hospital
kitchens, day care kitchens, and nursing home kitchens; and (2) pet
shelters, kennels, and veterinary facilities in which food is provided
to animals.
    See our responses to the comments on the proposed definition of
``retail food establishment'' for an explanation of the addition of a
definition for ``restaurant.''
38. Retail Food Establishment
    We proposed to define ``retail food establishment'' as it is
defined in the food facility registration regulation (Sec.  1.227),
i.e., as an establishment that sells food products directly to
consumers as its primary function. The definition further specified the
following:
     The term ``retail food establishment'' includes facilities
that manufacture, process, pack, or hold food if the establishment's
primary function is to sell from that establishment food, including
food that it manufactures, processes, packs, or holds, directly to
consumers;

     an RFE's primary function is to sell food directly to
consumers if the annual monetary value of sales of food products
directly to consumers exceeds the annual monetary value of sales of
food products to all other buyers;
     the term ``consumers'' does not include businesses;
     a ``retail food establishment'' includes grocery stores,
convenience stores, and vending machine locations; and
     a ``retail food establishment'' also includes certain
farm-operated businesses selling food directly to consumers as their
primary function.
    The proposed definition of ``retail food establishment'' further
specified that the sale of food directly to consumers from an
establishment located on a farm includes sales by that establishment
directly to consumers in the following circumstances:
     at a roadside stand (a stand situated on the side of or
near a road or thoroughfare at which a farmer sells food from his or
her farm directly to consumers) or farmers' market (a location where
one or more local farmers assemble to sell food from their farms
directly to consumers);
     through a CSA program. CSA program means a program under
which a farmer or group of farmers grows food for a group of
shareholders (or subscribers) who pledge to buy a portion of the
farmer's crop(s) for that season. This includes CSA programs in which a
group of farmers consolidate their crops at a central location for
distribution to shareholders or subscribers; and
     at other such direct-to-consumer sales platforms,
including door-to-door sales; mail, catalog and internet order,
including online farmers' markets and online grocery delivery;
religious or other organization bazaars; and State and local fairs.
    The proposed definition further stated that the sale of food
directly to consumers by a farm-operated business includes the sale of
food by that farm-operated business directly to consumers in the same
circumstances specified with respect to sale of food directly to
consumers from an establishment located on a farm.
    The proposed definition further stated that for the purposes of the
definition, ``farm-operated business'' means a business that is managed
by one or more farms and conducts manufacturing/processing not on the
farm(s).
    We are finalizing the definition of ``retail food establishment''
without change.
    (Comment 282) One comment asks if retail chains with in-store food
production meet the definition of an RFE under subpart S.
    (Response 282) If a retail chain store sells food products directly
to consumers as its primary function, then it meets the definition of
``retail food establishment.'' We are aware that many RFEs, such as
grocery stores, have in-store food production. As discussed in Section
V.O.3 of this document, Sec.  1.1350(c) of the final rule provides that
the recordkeeping requirements for the transformation of foods do not
apply to RFEs and restaurants with respect to foods they do not ship
(e.g., foods they sell or send directly to consumers).
    (Comment 283) One comment asks whether CSA programs are included in
the definition of ``retail food establishment.''
    (Response 283) The definition of ``retail food establishment''
specifies that a ``retail food establishment'' includes certain farm-
operated businesses selling food directly to consumers as their primary
function. The definition of ``retail food establishment'' further
specifies that the sale of food directly to consumers from an
establishment located on a farm includes sales by that establishment
directly to consumers through a CSA program, and that the sale of food
directly to consumers by a farm-operated business includes the sale of
food by that farm-operated business directly to consumers through a
CSA. The definition further states that a CSA program means a program
under which a farmer or group of farmers grows food for a group of
shareholders (or subscribers) who pledge to buy a portion of the
farmer's crop(s) for that season.
    (Comment 284) One comment asks whether the definition of ``retail
food establishment'' includes distribution centers.
    (Response 284) If a distribution center sells food products
directly to consumers as its primary function and otherwise meets the
above-stated definition of ``retail food establishment,'' it would be
an RFE for purposes of the subpart S requirements. However, we believe
it is likely that many distribution centers would not meet this
definition because most function to distribute food to wholesale or
retail locations as a primary function, rather than sell food directly
to consumers.
    (Comment 285) Many comments request clarification about whether
restaurants are included in the definition of ``retail food
establishment.'' Several comments recommend including restaurants,
online food retailers, and meal kit delivery companies in the
definition of ``retail food establishment,'' noting that we said in the
preamble to the proposed rule that we consider those operations to be
RFEs. The comments also note that the FDA Food Code includes
restaurants in the definition of ``food establishment,'' and maintain
that including restaurants in the definition of ``retail food
establishment'' would be consistent with the retail model code. Some
comments assert that issues have arisen in successfully tracing product
in the ``last mile,'' which includes many types of retail operations,
and therefore maintain that it is critical to include such operations
in the definition of ``retail food establishment.''
    (Response 285) We agree that it is important for restaurants to be
covered by subpart S, and we recognize that many commenters were
confused by the fact that restaurants were not mentioned in the
codified of the proposed rule. However, we decline to add restaurants
to the definition of a ``retail food establishment.'' We note that
``restaurant'' is a term that is defined separately from ``retail food
establishment'' in the food facility registration regulation (see Sec.
1.227), and that it is also independently defined in subpart J (see
Sec.  1.328). Therefore, to be consistent with other FDA regulations,
we are adding a definition of restaurant to Sec.  1.1310 (as described
above), and we are maintaining the proposed definition of ``retail food
establishment.'' We think this will achieve the clarity that commenters
sought regarding the application of subpart S to restaurants. The final
rule applies relevant provisions such as exemptions and CTE
requirements to both RFEs and restaurants in exactly the same manner,
using the phrase ``retail food establishments and restaurants.''
    As noted in the comment, the definition of ``food establishment''
in the FDA Food Code is different from the definition of ``retail food
establishment'' used in Sec.  1.227. We are considering how to address
this difference, but in the meantime we conclude that it is appropriate
to align subpart S with the existing definitions of ``retail food
establishment'' and ``restaurant'' in other FDA regulations.
    Regarding the request to add online food retailers and meal kit
delivery companies to the definition of ``retail food establishment,''
we have concluded that this revision is not necessary. We note that the
definition already explicitly addresses sales from establishments
located on farms and sales by farm-operated businesses on direct-to-
consumer sales platforms, including door-to-door sales and mail,

catalog, and internet order, including online farmers' markets and
online grocery delivery (see above and at Sec.  1.1310). More
generally, facilities that sell food directly to consumers via the
internet or mail-order may be RFEs, provided they meet the other
criteria of the ``retail food establishment'' definition in Sec.  1.227
(see Ref. 26).
39. Shipping
    We proposed to define ``shipping'' as an event in a food's supply
chain in which a food is arranged for transport (e.g., by truck or
ship) from a defined location to another defined location at a
different farm, a first receiver, or a subsequent receiver. The
definition further stated that shipping does not include the sale or
shipment of a food directly to a consumer or the donation of surplus
food. As explained below, we have changed the definition of
``shipping'' in the final rule.
    (Comment 286) A comment requests that we clarify the definition of
shipping and revise it to include the idea that it is movement of food
from a defined location to a customer, similar to the proposed
definition of ``receiving.''
    (Response 286) We decline to make this change. As stated in
Response 276, we have deleted the reference to a ``customer'' in the
definition of ``receiving'' because it caused confusion with respect to
the application of the receiving CTE requirements to intracompany
shipments. Consequently, we conclude that it would not be appropriate
to add a similar reference to a ``customer'' in the ``shipping''
definition. We also revised the definition of ``shipping'' to reflect
changes we are making to CTE requirements, including deletion of the
proposed requirements for the first receivers of FTL foods. Thus, the
revised definition specifies that ``shipping'' means an event in a
food's supply chain in which a food is arranged for transport (e.g., by
truck or ship) from one location to another location. Finally,
consistent with another change we made to the definition of
``receiving'' concerning intracompany shipments, we have revised the
definition of ``shipping'' to specify that it includes sending an
intracompany shipment of food from one location at a particular street
address of a firm to another location at a different street address of
the firm.
    (Comment 287) One comment asks that we clarify whether retailers
who donate food need to capture traceability information.
    (Response 287) The definition of ``shipping'' in Sec.  1.1310
specifically states that shipping does not include the donation of
surplus food. Therefore, retailers who donate food do not need to
document any traceability information relating to the donation.
However, they may need to document information relating to their
receipt of the food, unless another exemption applies.
    (Comment 288) One comment seeks clarification that shipping CTE
requirements do not apply to RACs shipped from the field or orchard to
the packinghouse.
    (Response 288) As discussed in Section V.M.3 of this document, the
shipping CTE requirements do not apply to shipment of a RAC that occurs
before the RAC is initially packed (see Sec.  1.1340(c)).
    (Comment 289) Some comments ask that we use consumer data and
reviews to help us conduct outbreak investigations. One comment
suggests that all food industry and regulated partners be required to
submit customer loyalty information and/or credit card information to
assist in the notification of customers who have purchased products
involved in outbreak investigations. One comment expresses concern that
we have substantially downplayed the utility of consumer-specific data.
The comment asserts that tracking lot numbers purchased by individual
consumers is not currently practical but asks that we encourage
industry, both conventional and e-commerce, to capture and voluntarily
submit consumer-specific data, such as customer loyalty or credit card
information. The comment asks that firms that currently maintain this
information not be inadvertently penalized or disproportionately
targeted because they have this information.
    (Response 289) As stated in the preamble to the proposed rule (85
FR 59984 at 59992), we support efforts by retailers to identify and
provide us with anonymized consumer purchase data during our
investigations into foodborne illness outbreaks. We agree that such
information can be very helpful in narrowing the scope of an
investigation and more quickly identifying the source of contamination.
We do not target or penalize firms that maintain this information;
rather, we encourage firms to make available any relevant consumer data
they might have. However, as stated in the preamble to the proposed
rule (85 FR 59984 at 60003), we believe that it would be too burdensome
to require retail facilities to keep traceability records of sales to
consumers, and we conclude that it not essential that we have access to
such records to effectively respond to threats to public health posed
by outbreaks. Therefore, the final rule does not require records of
sales to consumers. A sale of an FTL food to a consumer does not
constitute a shipping event (even if the sale involves transport of the
food, as with sales made over the internet), because the definition of
``shipping'' in Sec.  1.1310 specifies that shipping does not include
the sale or shipment of a food directly to a consumer.
40. Traceability Lot
    We proposed to define ``traceability lot'' as a lot of food that
has been originated, transformed, or created. As explained below, we
have revised the definition of ``traceability lot'' to align with
changes we have made to the proposed CTE requirements.
    (Comment 290) Some comments suggest that the definition of
``traceability lot'' is easily confused with the definition of ``lot.''
The comments express concern that the recordkeeping requirements will
be overly burdensome if FDA is not specific about the expectations for
maintaining records based on a lot or traceability lot of an FTL food.
    (Response 290) We recognize that proposing separate definitions for
``lot'' and ``traceability lot'' caused confusion among many
commenters. We have therefore deleted the definition of ``lot'' from
the rule and changed the definition of ``traceability lot'' to refer to
either a batch or lot of food. We have also revised the definition to
align with changes to the rule regarding when a traceability lot code
must be assigned (see Sec.  1.1320). The revised definition states that
a traceability lot is a batch or lot of food that has been initially
packed (for RACs other than food obtained from a fishing vessel),
received by the first land-based receiver (for food obtained from a
fishing vessel), or transformed.
    (Comment 291) One comment asks how many fish from multiple fishing
vessels can be used in one finished-product lot. Several comments
request guidance on how a lot should be created to encourage uniformity
across industry.
    (Response 291) The rule places no limits on how much of an FTL food
can be put into a lot, or how many different sources (including
different fishing vessels) the food can be from. (See Section V.E.9 of
this document for a discussion of commingling RACs, including RACs
obtained from fishing vessels.) We believe industry should have the
flexibility to determine how to create traceability lots in a manner
that works best for their operations. This approach is consistent with
the approach to the creation of lots under the regulation on preventive
controls for human food.

41. Traceability Lot Code
    We proposed to define ``traceability lot code'' as a descriptor,
often alphanumeric, used to identify a traceability lot.
    (Comment 292) Several comments suggest that the term ``traceability
lot code'' be replaced by another phrase to indicate its special status
and avoid use of the word ``lot,'' maintaining that the concept of
``lot'' already has varied usage and might cause confusion. One comment
suggests using the term ``traceability code'' instead of ``traceability
lot code.''
    (Response 292) We disagree with the comments. The traceability lot
code, assigned to a traceability lot of a food on the FTL, is the key
to the subpart S traceability framework because it is the piece of
information to which the other KDEs for a traceability event are
linked. While we are providing flexibility for industry to determine
how to create traceability lots in a way that work best for their
operations, we think that the concept of a ``lot'' is well understood
within industry (as is the concept of lot-based traceability), and we
want our terminology to communicate that the traceability lot code is
assigned to a specific lot (i.e., the traceability lot) of the food.
Therefore, we believe it is important to retain the reference to a
``lot'' in the definition. In addition, to improve a traceability lot
code's ability to help identify a particular FTL product, and in
response to comments suggesting that the traceability lot code be
globally unique (see Response 507), we have revised the definition of
``traceability lot code'' to state that it is a descriptor, often
alphanumeric, used to uniquely identify a traceability lot within the
records of the traceability lot code source (i.e., the place where the
traceability lot code was assigned to a food).
    (Comment 293) One comment requests that we clarify that a lot code,
batch code, or production code for a food on the FTL can be the
traceability lot code if it meets the definition of a traceability lot
code.
    (Response 293) We agree that a lot code, batch code, or other
production code for an FTL food could be used as a traceability lot
code if it meets the definition of ``traceability lot code'' stated
above.
    (Comment 294) One comment suggests that the definition of
``traceability lot code'' account for the activity of harvesting, as
lots are identified when a product is harvested.
    (Response 294) We decline to make this revision. We acknowledge
that lots are sometimes identified at the point of harvesting; however,
we received several comments stating that RACs are most often assigned
lot codes at initial packing. Therefore, Sec.  1.1320 of the final rule
requires that a traceability lot code be assigned when a person
initially packs a RAC other than a food obtained from a fishing vessel,
performs the first land-based receiving of a food obtained from a
fishing vessel, or transforms a food. Under the final rule, lot-based
recordkeeping is not required at harvest or at any point before the
initial packing (or first land-based receiving) of a RAC. This topic is
further discussed in Section V.J of this document.
    (Comment 295) One comment recommends that we consider FDA
Establishment Identifier numbers, Food Facility Registration Numbers,
or DUNS numbers as alternatives to traceability lot codes under the
subpart S requirements.
    (Response 295) As previously stated, a traceability lot code is a
descriptor that must uniquely identify a traceability lot within the
records of the traceability lot code source. If a firm chooses to
create traceability lot codes incorporating numbers assigned by FDA or
DUNS, they may do so, provided the resulting code meets the definition
of a ``traceability lot code,'' including that the code uniquely
identifies a particular lot within the firm's tracing records.
42. Traceability Lot Code Generator
    We proposed to define ``traceability lot code generator'' as the
person who assigns a traceability lot code to a product. We received
several comments expressing confusion about the concept of a
``generator'' of a traceability lot code and concern about providing
information identifying the traceability lot code generator to
customers (see Response 412). As explained below, for clarity in the
final rule, we have replaced the term ``traceability lot code
generator'' with the term ``traceability lot code source.''
    (Comment 296) Several comments maintain that the proposed rule puts
too much emphasis on the traceability lot code generator and suggest
that there is confusion around capturing information about the
``person'' that assigned the traceability lot code to a product.
    (Response 296) We agree that, with respect to the assignment of
traceability lot codes, the focus for traceability should be on the
place where the code was assigned, rather than the specific individual
or entity who assigned the code. Because the traceability lot code is
an integral component of the subpart S traceability requirements, it is
important to document the physical location where the traceability lot
code for an FTL food was assigned. During outbreak situations, this
will allow FDA to more quickly identify this location and prioritize
where we need to collect tracing data, which in turn will help us more
quickly identify the origin of contaminated food. Therefore, we
conclude that it is appropriate to replace the term ``traceability lot
code generator'' with ``traceability lot code source,'' which we define
as the place where a food was assigned a traceability lot code. Unless
the relevant entity is exempt from the rule, the traceability lot code
source will be the place where the food was initially packed (for RACs
not obtained from a fishing vessel), received by the first land-based
receiver (for food obtained from a fishing vessel), or transformed.
    (Comment 297) One comment requests clarity about who is considered
the traceability lot code generator in situations of contract
manufacturing. Specifically, the comment asks whether the contract
manufacturer or the entity that initiated the contract should be
regarded as the traceability lot code generator.
    (Response 297) As discussed above, in the final rule we have
replaced the term ``traceability lot code generator'' with the term
``traceability lot code source.'' If the contract manufacturer made the
FTL product at their facility, that facility would be the traceability
lot code source for the food, consistent with the definition of
``traceability lot code source'' stated above (which refers to the
``place'' where a traceability lot code was assigned).
    (Comment 298) Some comments maintain that for businesses that use
random number generators to assign lot codes, a requirement to name the
individual who assigned a traceability lot code would be superfluous.
    (Response 298) As previously stated, we agree that it is
unnecessary to keep a record of the identity of the individual who
assigned a traceability lot code to the food. Instead, firms must
document the place where the traceability lot code was assigned, i.e.,
the traceability lot code source.
43. Traceability Lot Code Source
    As stated above, we are replacing the term ``traceability lot code
generator'' with the term ``traceability lot code source.'' The final
rule defines ``traceability lot code source'' to mean the place where a
food was assigned a traceability lot code. Unless the relevant entity
is exempt from the rule, this will be the place where the food was
initially packed (for RACs not obtained from a fishing vessel), first
processed on land

(for food obtained from a fishing vessel), or transformed.
44. Traceability Lot Code Source Reference
    We are adding a definition of ``traceability lot code source
reference.'' The final rule defines ``traceability lot code source
reference'' to mean an alternative method for providing FDA with access
to the location description for the traceability lot code source as
required under subpart S. The definition goes on to state that examples
of a traceability lot code source reference include, but are not
limited to, the FDA Food Facility Registration Number for the
traceability lot code source or a web address that provides FDA with
the location description for the traceability lot code source. If a
firm uses a web address as the traceability lot code source reference,
the associated website may employ reasonable security measures, such as
only being accessible to a government email address, provided FDA has
access to the information at no cost and without delay. We are adding
this definition and provisions concerning the use of traceability lot
code source references in response to comments expressing concern about
data privacy associated with the provision of information on the
traceability lot code generator (now the traceability lot code source)
(see Section V.M of this document).
45. Traceability Product Description
    We proposed to define ``traceability product description'' as a
description of a food product typically used commercially for
purchasing, stocking, or selling, and as including the category code or
term, category name, and trade description. The definition further
stated that for single-ingredient products, the trade description
includes the brand name, commodity, variety, packaging size, and
packaging style; for multiple-ingredient food products, the trade
description includes the brand name, product name, packaging size, and
packaging style. As previously stated, we are deleting the term
``traceability product description'' and replacing it with the term
``product description.'' In response to the comments on the proposed
definition of ``traceability product description,'' we made changes
that are incorporated into the definition of ``product description'' in
the final rule.
    (Comment 299) Several comments urge FDA to simplify the
requirements for the traceability product description. The comments
suggest that the traceability product description is unnecessary for
tracing, contains information not currently used, and is redundant and
irrelevant to food traceability. One comment suggests that category
code or term and category name (which are part of the proposed
definition of ``traceability product description'') should be optional.
This comment recommends that much of the information under a
traceability product description be required only as applicable.
    (Response 299) We agree that not all of the information included in
the proposed definition of ``traceability product description'' is
needed, and we have simplified the definition of ``product
description'' in the final rule. As discussed below, we have removed
the requirement for information on ``category'' as part of the product
description and we have removed the distinction between information
needed for single-ingredient products and multi-ingredient products. To
address differences between these types of products, the definition of
``product description'' in the final rule specifies that the product
name includes the brand name, commodity, and variety ``if applicable''
(because, for example, a multi-ingredient product might not have a
commodity or variety name).
    Although we have simplified the information required under a
product description, we do not agree that information fully describing
an FTL product is irrelevant to tracing, because it provides
information we need to be able to conduct traceback investigations and
accurately identify the source of contaminated food. Therefore, the
final rule includes requirements to keep a record of the product
description as one of the KDEs for several traceability events. The
final rule uses the term ``product description'' rather than
``traceability product description'' to eliminate potential confusion
regarding the use of a new term. The final rule defines ``product
description'' to mean a description of a food product and to include
the product name (including, if applicable, the brand name, commodity,
and variety), packaging size, and packaging style. The definition
further states that for seafood, the product name may include the
species and/or acceptable market name.
    (Comment 300) Some comments recommend adding the GS1 Global Trade
Item Number (GTIN) to the traceability product description and seek
clarification of the concept of ``category'' as a component of the
description.
    (Response 300) Having reconsidered the components of the proposed
definition of ``traceability product description,'' we conclude that it
is not necessary to include a product's category code/term or category
name as part of a product description. Regarding the suggestion to add
a GTIN to the product description, we do not believe that would be
appropriate because GTINs are not universally used in the food
industry. However, a firm that uses GTINs may choose to include that
information as part of their product description. This could be done
either by adding it to the required information, or by using it as a
shorthand for some or all of the required information, provided that a
glossary or key is maintained (and, if necessary, shared) to indicate
the full product description that corresponds to the GTIN.
46. Traceability Product Identifier
    We proposed to define ``traceability product identifier'' as a
unique identification code (such as an alphanumeric code) that an
entity assigns to designate a specific type of food product. As
explained below, we are deleting this definition from the final rule.
    (Comment 301) One comment requests examples of the traceability
product identifier and asks if we meant numbers such as a GTIN or an
Internal Item Number. The comment asserts that the need for uniqueness
would be a concern, particularly to prevent duplication with
traceability product identifiers assigned by other covered entities.
    (Response 301) The final rule does not include a definition of
``traceability product identifier'' because we have deleted the
proposed requirements to establish a product identifier for an FTL food
for certain CTEs. In the proposed rule, we included a traceability
product identifier, along with the traceability product description, as
important descriptive information for FTL foods to help us during
tracebacks, because different firms often use different names for the
same product (e.g., ``Maradol papayas'' instead of ``papayas'').
However, in response to comments requesting that we simplify the KDEs,
we conclude that it is not necessary to require firms to keep a product
identifier for a food to ensure that there is adequate information for
efficient traceability (see Section V.M.1 of this document).
    (Comment 302) One comment asks that we revise the definition of
traceability product identifier to allow covered entities to describe
the relationship between different packaging configurations of the same
product. The comment maintains that current industry standards enable
firms to declare a relationship between

consumer-ready packaging and higher levels of packaging used to
transport the consumer-ready packages through the supply chain to RFEs.
The comment asserts that this ability to determine the parent/child
relationship between product identifiers is important for tracking the
movement of products.
    (Response 302) As previously stated, we have deleted the proposed
requirements to keep a record of the traceability product identifier
for FTL foods. However, if the product hierarchy described in the
comment is an important component of a firm's traceability records, the
firm may wish to include product identifier information as part of the
product descriptions it keeps for FTL foods the firm handles.
    (Comment 303) One comment maintains that for molluscan shellfish
the unique product identifier would be the same as the product
description.
    (Response 303) As stated in Response 301, we have deleted the
definition of traceability product identifier as well as all of the
proposed requirements to keep a record of a product identifier. We also
note that, as discussed in Section V.E.7 of this document, the final
rule exempts certain raw bivalve molluscan shellfish from the subpart S
requirements.
47. Transformation
    We proposed to define ``transformation'' as an event in a food's
supply chain that involves changing a food on the FTL, its package,
and/or its label (regarding the traceability lot code or traceability
product identifier), such as by combining ingredients or processing a
food (e.g., by cutting, cooking, commingling, repacking, or
repackaging). The definition further stated that transformation does
not include the initial packing of a single-ingredient food or creating
a food. In the final rule, we have combined the proposed CTEs of
``transformation'' and ``creating'' into a single ``transformation''
CTE and revised the definition of ``transformation'' accordingly, as
discussed in response to the following comments.
    (Comment 304) One comment maintains that the proposed definition of
``transformation'' is well defined and aligns with current industry
practices. However, several comments recommend that we recognize that
creation and transformation are essentially the same and that any
differentiation is based solely on whether the foods used are on the
FTL. These comments maintain that, with respect to the requirements for
traceability lot code assignment and linkage, having to differentiate
between creation and transformation could become complex for processors
that have multiple manufacturing steps within their facilities that
result in different products. These comments assert that current
industry traceability standards designate all such activities as
``transformation.''
    (Response 304) We conclude that it is appropriate to use the term
``transformation'' to cover both the activities we described in the
proposed definition of that term as well as the activities described in
the proposed definition of ``creating'' (see Section V.O of this
document). Therefore, the final rule defines ``transformation'' as an
event in a food's supply chain that involves manufacturing/processing a
food or changing a food (e.g., by commingling, repacking, or
relabeling) or its packaging or packing, when the output is a food on
the FTL. The definition further states that transformation does not
include the initial packing of a food or activities preceding that
event (e.g., harvesting, cooling). We conclude that this revised
definition of ``transformation'' more closely aligns with current
industry practices while helping to ensure that firms understand the
recordkeeping requirements applicable to transformation activities.
    (Comment 305) Several comments state that farms often repack
produce from within the same lot and request that such repacking be
excluded from the definition of ``transformation.'' The comments
further ask that FDA clarify that repacking only takes place at
``facilities'' and not at ``farms.''
    (Response 305) We decline to make the changes requested by the
comments. Repacking whole fresh produce within one traceability lot is
considered transformation under subpart S. Repacking whole fresh
produce may introduce contamination, whether the repacking is done at a
facility or a farm. (Though as previously stated, transformation does
not include the initial packing of a RAC.) At the repacking stage, the
traceability lot code can be changed or the traceability lot code of
the original lot can be retained, but a new traceability lot code
source would be required to identify the repacker, and the KDEs
identified in Sec.  1.1350 would need to be maintained.
    (Comment 306) One comment asks FDA to reconsider treating
repackaging of molluscan shellfish as a transformation event. The
comment suggests that repackaging could involve dividing a traceability
lot into smaller traceability lots. The comment asserts that applying
transformation recordkeeping requirements to repackaging would impose a
significant recordkeeping burden and impair traceability by introducing
potential errors.
    (Response 306) We decline to revise the definition of
``transformation'' as requested. We consider repackaging (and
repacking) to be transformation events under subpart S because
repackaging and repacking may introduce contamination, and because in
many situations they have the potential to impede traceability by
dividing one lot into several lots, or by commingling lots. Regarding
the repackaging of molluscan shellfish (most of which are likely exempt
from the rule under Sec.  1.1305(f)), a traceability lot code could
have been assigned by the initial packer or first land-based receiver
of the shellfish at one facility and then again during repacking at
another facility, in accordance with Sec.  1.1320 of the final rule. At
the repacking stage, the traceability lot code can be changed or the
traceability lot code of the original lot can be retained (assuming
there has been no commingling of lots), but a new traceability lot code
source would be required to identify the repacker. If the second
facility was not identified as the traceability lot code source for the
repackaged product, an investigator might initially miss a potentially
important node in a traceback investigation.
    (Comment 307) One comment asks whether transformation KDEs are
required following the breaking of a master case of product into
smaller units, which the comment maintains is a common practice during
foodservice distribution.
    (Response 307) We understand that the breaking of a master case
into smaller units is a common practice during food distribution. The
breaking of a master case during foodservice distribution does not
necessarily constitute transformation. If, as part of the breaking of
the master case, the product is repacked or repackaged, then this would
constitute transformation, as described in Response 305. However, if a
distributor or other entity is simply breaking a master case (e.g., a
pallet containing 20 individual cases) into separate shipments (e.g., 4
shipments of 5 cases each), this would not constitute transformation.
In this instance, the distributor would only need to follow the
requirements for shipping and receiving under Sec. Sec.  1.1340 and
1.1345, respectively. Because no transformation event has occurred, the
distributor would not keep transformation records under Sec.  1.1350,
nor would they assign a traceability lot code or become the
traceability lot code source. If the pallet

contained cases associated with different traceability lot codes, the
shipping records would use those traceability lot codes to indicate
which traceability lots were shipped to which location.
    (Comment 308) One comment expresses concern that changing a food
label is within the definition of ``transformation.'' The comment
supports a narrow interpretation of the changes to food labels that are
regarded as transformation and maintains that changing the brand on a
label should not be considered transformation.
    (Response 308) We disagree with the comment. The final rule
specifies that the brand name (if any) is a component of the product
description of an FTL food, and changing a brand name on labeling would
be transformation under the rule. We believe that including
``relabeling'' in the definition of ``transformation'' is consistent
with current practice in much of the industry, for example for entities
following the Produce Traceability Initiative (PTI) or GS1 GTIN
standards.
48. Transporter
    We proposed to define ``transporter'' as a person who has
possession, custody, or control of an article of food for the sole
purpose of transporting the food, whether by road, rail, water, or air.
We did not receive any comments on this definition and are finalizing
it as proposed.
49. Vessel Identification Number
    We proposed to define ``vessel identification number'' to mean the
number assigned to a fishing vessel by the International Maritime
Organization, or by any entity or organization, for the purpose of
uniquely identifying the vessel. As discussed in Response 388, we are
deleting proposed requirements to record the vessel identification
number at certain CTEs, so we are deleting the definition of ``vessel
identification number'' from the rule.
    (Comment 309) One comment maintains that for molluscan shellfish,
the rule should use the aquaculture lease number instead of the vessel
identification number. The comment further states that aquaculture
farms and wild harvesters of molluscan shellfish do not use boats, and
that the harvest area or lease number would provide more useful
information.
    (Response 309) As discussed in Section V.E.7 of this document, the
final rule exempts from subpart S raw bivalve molluscan shellfish that
are covered by the requirements of the NSSP, subject to the
requirements of part 123, subpart C, and Sec.  1240.60, or covered by a
final equivalence determination by FDA for raw bivalve molluscan
shellfish. For molluscan shellfish that are subject to subpart S, the
final rule has no requirements to maintain a record of the vessel
identification number.
    (Comment 310) One comment agrees with the proposed definition of
``vessel identification number.'' One comment asks for clarification
whether vessel identification numbers assigned by agencies other than
the International Maritime Organization meet the requirements of the
rule.
    (Response 310) As stated above, because the final rule contains no
requirements for the maintenance of vessel identification numbers, we
are deleting the definition of ``vessel identification number'' from
the rule.
50. You
    We proposed to define ``you'' to mean a person subject to subpart S
under Sec.  1.1300. We did not receive any comments on this definition
and have finalized it as proposed.
51. Comments Requesting Additional Definitions
    We received comments requesting that the rule include definitions
for additional terms. We decline to add these definitions, for the
reasons set forth below.
    (Comment 311) One comment asks that we provide additional clarity
around use of the term ``broker'' in the rule. The comment maintains
that use of the term ``broker'' is confusing because food brokers and
customs brokers serve different functions.
    (Response 311) Because the final rule does not include the word
``broker,'' there is no need to specify a definition of the term. The
preamble to the proposed rule (85 FR 59984 at 60000) only mentioned
brokers in the context of saying that food brokers who negotiate sales
of food from producers to wholesalers, retail stores, and others but
never physically possess the food would not be subject to the rule.
This was just one example of how a person who does not take physical
possession of an FTL food is not engaged in the holding of the food and
therefore would not be subject to the rule.
    (Comment 312) One comment requests that we include a definition of
``facility'' that is consistent with the definition of ``facility'' in
other FSMA rules.
    (Response 312) We decline to define the term ``facility'' in the
final rule. As discussed in Section V.D of this document, although
section 204(d)(1) of FSMA refers to ``facilities'' that manufacture,
process, pack, or hold food, the final rule is phrased in terms of
``persons'' that manufacture, process, pack, or hold food, to avoid
possible confusion with other uses of the term ``facilities'' in other
FDA food regulations. Because the final rule does not include
requirements that apply specifically to ``facilities,'' we conclude
that it is not necessary to include a definition of ``facility'' in the
rule.
    (Comment 313) Several comments ask for a definition and
clarification on the meaning and application of ``fresh-cut'' regarding
activities that are considered part of harvesting, such as trimming,
field coring, and washing, as compared to activities that are
considered to take place after harvesting. The comments request that we
clarify how processing activities that result in ``fresh-cut'' produce
differ from those that are part of traditional harvesting, such as
trimming and cutting.
    (Response 313) Because the subpart S regulations do not refer to
``fresh-cut'' produce, there is no need to add a definition of ``fresh-
cut'' to the rule. In the RRM-FT, we define fresh cut commodities based
on FDA's ``Guide to Minimize Food Safety Hazards of Fresh-cut Produce:
Draft Guidance for Industry'' (https://www.fda.gov/media/117526/download), which states that ``fresh-cut produce'' means any fresh
fruit or vegetable or combination thereof that has been physically
altered from its whole state after being harvested from the field. In
addition, a description of the foods on the FTL is available on the FDA
website to aid stakeholders in determining whether a specific food is
covered.
    (Comment 314) Several comments request that we define the terms
``owner,'' ``operator,'' and ``agent in charge'' or address these terms
in guidance. One comment suggests that the rule define ``agent in
charge'' as a person who is employed by or contracted by an entity, has
responsibility for traceability recordkeeping, and is not necessarily
the owner.
    (Response 314) We decline these requests. The phrase ``owner,
operator, or agent in charge'' is statutory language (in section
204(d)(6)(C) and (d)(6)(I)(ii) of FSMA) used in subpart S only in
certain exemptions related to farms (Sec.  1.1305(b) and (j)) and
fishing vessels (Sec.  1.1305(m)). Because this phrase ``owner,
operator, or agent in charge'' is used frequently in the produce safety
regulation, which applies to farms, and the term ``operator'' is used
throughout FDA's ``Fish and Fishery Products Hazards and Controls
Guidance'' (Ref. 23), we believe that the meaning of these terms is
generally understood by

relevant covered entities. Therefore, we conclude that it is not
necessary to add definitions of these terms to the rule.
    (Comment 315) Some comments request that we add a definition of
``smoked'' to the rule.
    (Response 315) We decline this request because the word ``smoked''
does not appear in the subpart S regulations. In the RRM-FT, we define
smoked finfish based on FDA's ``Fish and Fishery Products Hazards and
Controls Guidance,'' which has the same definition for ``smoked or
smoke-flavored fishery products'' as that in the seafood HACCP
regulation (Sec.  123.3(s)). We believe that relevant covered entities
understand the term ``smoked.'' In addition, a description of the foods
on the FTL is available on the FDA website to aid stakeholders in
determining whether a specific food is covered.
    (Comment 316) Several comments request that we define ``sprouts''
in the final rule.
    (Response 316) We decline to define ``sprouts'' in the final rule.
The produce safety regulation (part 112), which includes a sprout-
specific section (subpart M), does not define the term ``sprouts.''
However, subpart M makes a distinction between soil- or substrate-grown
sprouts harvested without their roots, and all other sprouts (see 21
CFR 112.141). Therefore, we believe that sprout growers will understand
the use of the term ``sprouts'' in this final rule. We have clarified
in the final rule that the sprout-specific provisions of Sec.
1.1330(b) do not apply to soil- or substrate-grown sprouts harvested
without their roots.

G. Traceability Plan (Sec.  1.1315)

    In the provisions of proposed subpart S that are under the heading
``Traceability Program Records,'' we proposed to require entities
subject to the rule to keep traceability program records for the FTL
foods they handle (proposed Sec.  1.1315), and we specified when
entities must assign traceability lot codes to FTL foods (proposed
Sec.  1.1320). Proposed Sec.  1.1315 stated that covered entities must
establish and maintain records related to their traceability program.
These records would include a description of the reference records in
which the required information is maintained, an explanation of where
on the records the required information appears, and if, applicable, a
description of how reference records for different tracing events for a
food are linked (proposed Sec.  1.1315(a)(1)). We also proposed that
required entities must establish and maintain a list of foods on the
FTL that they ship, including the traceability product identifier and
traceability product description for each food, and a description of
how the entity establishes and assigns traceability lot codes to foods
on the FTL they originate, transform, or create, as well as any
additional information necessary to understand the data provided within
any of the records required under subpart S, such as internal or
external coding systems, glossaries, and abbreviations (proposed Sec.
1.1315(a)(2) through (4)). We proposed that these traceability program
records be retained for 2 years after their use is discontinued
(proposed Sec.  1.1315(b)).
    To better capture the intent of this section and to align our
approach with other FSMA regulations, we have revised Sec.  1.1315 to
set forth the requirements for a firm's ``traceability plan.'' Rather
than describe the reference records that a firm uses to document
required information, revised Sec.  1.1315(a)(1) requires firms to
describe their procedures for maintaining FTL records; and rather than
maintaining a list of FTL foods shipped, revised Sec.  1.1315(a)(2)
requires firms to describe their procedures for identifying FTL foods
they handle. In alignment with other changes we are making concerning
requirements applicable to farms, revised Sec.  1.1315(a)(5) requires
persons who grow or raise an FTL food (other than eggs) to maintain a
farm map as part of their traceability plan. These and other changes to
proposed Sec.  1.1315 are discussed in response to the comments set
forth below.
1. General
    (Comment 317) One comment asks that we require firms have a product
tracing plan. The comment refers to the 2012 IFT Final Report (Ref. 1),
which includes a recommendation that FDA require that each member of
the food supply chain develop, document, and exercise a product tracing
plan containing the following elements: identified CTEs and KDEs;
identification of how information is recorded and linked; identified
authorized points of contact; metrics for trace data reporting response
times; and frequency of trace plan exercises and review. One comment
recommends that the subtitle of ``Traceability Program Records''
(encompassing proposed Sec. Sec.  1.1315 and 1.1320) should be renamed
because, according to the comment, that terminology does not align with
language used in other FSMA regulations, such as those for allergen
control or supply chain verification.
    (Response 317) We agree with the comments that it is appropriate
for entities to have a traceability plan for the FTL foods they handle.
As stated in the preamble to the proposed rule (85 FR 59984 at 60004),
we believe it is important that firms be able to provide information on
how they conduct their required traceability operations to help us
understand the records we review in an outbreak investigation. To make
this clear in the final rule, we have revised the subtitle
``Traceability Program Records'' to ``Traceability Plan,'' and we have
revised Sec.  1.1315(a) to state that if an entity is subject to the
subpart S requirements, it must establish and maintain a traceability
plan containing, as discussed below, a description of the procedures
the firm uses to maintain its traceability records (including the
format and location of the records), a description of the procedures
used to identify foods on the FTL that the firm handles, a description
of how the entity assigns traceability lot codes, a statement
identifying a point of contact for questions regarding the traceability
plan and records, and, if the entity grows or raises foods on the FTL
(other than eggs), a farm map. In addition, the final rule requires
entities to update their traceability plans as needed to ensure that
the information provided reflects the entity's current practices and to
ensure compliance with subpart S (see Section V.F.8 of this document).
The previous plan must be retained for 2 years after any updates (Sec.
1.1315(b)).
    (Comment 318) Several comments ask if the proposed traceability
program records requirements would apply to each SKU, ingredient, or
commodity.
    (Response 318) As stated in Response 317, Sec.  1.1315(a) of the
final rule requires covered entities to establish and maintain a
traceability plan containing information relating to their traceability
procedures. Persons subject to subpart S are not required to have a
separate plan for each food on the FTL they handle; instead, they can
have a single plan that covers all FTL foods they handle, provided that
the plan describes, among other things, the procedures used to maintain
the records required to be kept for all such foods.
    (Comment 319) One comment asks how the requirement to establish and
maintain traceability program records would be applied to foreign
exporters and establishments.
    (Response 319) The subpart S requirements apply to all entities,
domestic and foreign, that manufacture, process, pack, or hold foods on
the FTL (unless an exemption applies). Thus, foreign exporters and
other firms that manufacture, process, pack, or hold FTL foods will be
required to maintain a traceability plan under Sec.  1.1315 of the
final rule.

2. Description of Procedures Used To Maintain Records
    (Comment 320) Several comments request clarity on the requirement
in proposed Sec.  1.1315(a)(1) to maintain a description of the
reference records in which information required under subpart S is
maintained. One comment supports the flexibility FDA provided in
allowing covered entities to use whatever reference record suits their
operations (e.g., BOLs, ASNs) rather than requiring that information be
maintained in a particular record.
    (Response 320) As stated in section V.F.33 of this document,
elsewhere in the final rule we have replaced the term ``reference
record'' with ``reference document,'' which the final rule defines as a
business transaction document, record, or message, in electronic or
paper form, that may contain some or all of the KDEs for a CTE in the
supply chain of a food. In addition, to address confusion about the
meaning (in proposed Sec.  1.1315(a)(1)) of a ``description of the
reference records'' in which a firm keeps information required under
the rule, we conclude that the focus of a firm's traceability plan
should be on the procedures it uses to maintain records required under
subpart S. Therefore, we have deleted from Sec.  1.1305(a)(1) the
proposed requirement to describe the reference records a firm uses;
instead, Sec.  1.1305(a)(1) requires that an entity's traceability plan
include a description of the procedures the entity uses to maintain the
records it is required to keep under subpart S, including the format
and location of these records. Under Sec.  1.1305(a)(1), firms will not
need to identify each reference document it has used to record the KDEs
of each CTE for each FTL food it handles, but rather to describe the
general recordkeeping procedures it follows in meeting its subpart S
requirements, including the format in which it keeps these records and
where they are stored. Information on the format and location can
include, for example, a description of the electronic system of FTL
records that contains the KDEs, if that is the firm's practice. As
another example, information on the format and location may include a
description of the firm's receipt and storage of business documents as
FTL records, or practice of scanning or data entry from such records
that contain the KDEs, if that is the firm's practice.
    (Comment 321) One comment requests that the final rule clarify how
reference records for different CTEs are linked and whether records
must be linked electronically. The comment suggests that linking be
defined as the ability of a covered entity to use information on one
record to identify additional relevant records. Another comment opposes
the proposed requirement to describe how the reference records used for
different tracing events are linked because two firms might assign
different lot codes to a product shipment that are not connected by
records to the incoming product.
    (Response 321) As stated in Response 320, we are deleting the
proposed requirement to describe reference records used and to describe
how reference records for different tracing events are linked. The
final rule does not require that the traceability plan include a
description of how reference documents for different CTEs for an FTL
food are linked. However, the provisions applicable to each CTE require
entities to link the required KDEs for the event (including the
traceability lot code) to the particular traceability lot. Because the
traceability lot code is documented at each CTE, these requirements
will enable FDA to effectively trace a specific traceability lot across
multiple CTEs.
    Although the final rule does not define ``linking,'' we agree with
the comment that linking can involve connecting information about a CTE
that appears on one record with another record that contains other KDEs
for that event or with a record that contains KDEs for the next event
in the supply chain. For all CTEs, the final rule requires firms to
maintain records containing and linking certain KDEs to a particular
traceability lot. KDEs for a CTE could be ``linked'' in different ways,
including by being listed together in single row of an electronic
sortable spreadsheet, stored together as a record in a database, shared
to a subsequent recipient as an electronic message, or printed on the
same commercial document (e.g., BOL). KDEs may also be linked together
using a common identifier on multiple records, such as the traceability
lot code or the reference document number (e.g., a PO number attached
to a buyer's PO; a supplier's BOL that connects to a customer's
invoice).
3. Description of Procedures Used To Identify Foods on the Food
Traceability List
    (Comment 322) Several comments ask that we delete the proposed
requirement to maintain a list of foods on the FTL that a firm ships,
asserting that meeting the requirement would require substantial time
and resources because products and circumstances change often, which
would necessitate frequent updating of the list. The comments also
maintain that the list would become outdated almost immediately and
would not be helpful to FDA in protecting public health. The comments
further state that the list would include foods subject to a kill step
and shipments of ingredients and semi-finished foods, all of which
would require a burdensome case-by-case review. The comments maintain
that in the event of a food safety investigation, firms can generate
automated reports to gather current information about products, such as
a list of finished goods that contain a specific ingredient. Some
comments assert that when FDA conducts a traceforward it has already
identified a food or foods it is investigating, making it unnecessary
for firms to keep a list. Some comments maintain that most firms keep
shipping records for all their products, and they ask that if the final
rule includes this listing requirement, firms should be allowed to
include FTL foods within their existing records, rather than create a
separate list. One comment maintains that although they see the
usefulness in having a master list of all the FTL foods shipped, they
do not understand why this is essential for facilitating foodborne
illness investigations because all shippers will be required to
maintain and send the KDEs associated with FTL foods. The comment
contends that it is unrealistic for entities that only receive and ship
foods to establish this master list because they must rely on
information provided by the previous shipper.
    Some comments ask that we exempt food service distributors,
including fresh produce distribution centers, from the requirement to
keep a list of FTL foods shipped. The comments maintain that the
requirement would burden small specialty food distributors and
ingredient distributors because distributors ship large volumes of
product from many different firms daily. Another comment maintains that
this requirement would impose a burden on fresh produce distribution
centers because of the large number of listed products and the need to
frequently change the list; one comment estimated that based on current
practices, the FTL list could change, on average, every 3 minutes. The
comments also maintain that requiring the traceability identifier and
traceability product description as part of the list of FTL foods
shipped would further increase the burden on distributors because they
would have to maintain a list of each individual supplier for each
covered product they ship. The comments assert that

maintaining the list would provide little traceability value and would
be less relevant to distributors because they do not create or
transform food.
    (Response 322) We agree with the comments that the requirement to
keep a list of FTL foods shipped could be burdensome and is not
necessary to ensure adequate traceability of these foods. Therefore, we
are deleting the proposed requirement from the final rule. Instead,
Sec.  1.1315(a)(2) of the final rule specifies that an entity's
traceability plan must include a description of the procedures the
entity uses to identify foods on the FTL that it manufactures,
processes, packs, or holds. We conclude that this requirement will help
us understand how a firm identifies which of the foods it handles
require records under subpart S.
    (Comment 323) Several comments ask that we clarify how frequently
an entity must update the list of foods on the FTL that it ships.
    (Response 323) Because we are deleting the proposed requirement to
maintain a list of FTL foods shipped, there is no need to specify how
frequently the list should be updated.
4. Description of How Traceability Lot Codes Are Assigned
    (Comment 324) Some comments request additional guidance on the
creation and assignment of traceability lot codes, including more
information about the entity that creates the code and whether the code
will be maintained throughout the supply chain, how to identify foods
with a traceability lot code, and how to communicate the traceability
lot code to subsequent recipients. The comments also recommend that we
adopt a specific format or system for use in creating and assigning
traceability lot codes. Some comments suggest that compliance and
enforcement will be difficult to attain if the rule allows companies to
choose how they wish to assign traceability lot codes.
    (Response 324) We decline to specify a particular method or system
by which firms must assign traceability lot codes, because we think it
is appropriate for firms to have the flexibility to choose the approach
that best suits their needs. Several food industry-supported
traceability initiatives offer best practices and standards for
uniquely identifying a food using a combination of a globally unique
product identifier, firm-assigned internal lot code, and standard date
code. This information, taken together, could be used as a traceability
lot code, provided it meets the definition of ``traceability lot code''
in Sec.  1.1310 of the final rule. Because traceability lot codes are
central to subpart S, and because we are providing flexibility
regarding how a firm chooses to assign such codes, Sec.  1.1315(a)(3)
requires that, for firms that assign traceability lot codes, their
traceability plan must include a description of how they assign them.
    Although the rule allows for flexibility in the structure and
format of traceability lot codes, Sec.  1.1320 of the final rule limits
the circumstances under which traceability lot codes may be assigned.
As discussed in Section V.H of this document, Sec.  1.1320(a) of the
final rule specifies that firms must assign a traceability lot code
when they initially pack a RAC other than a food obtained from a
fishing vessel, perform the first land-based receiving of a food
obtained from a fishing vessel, or transform a food. Under Sec.
1.1320(b), except as specified otherwise in subpart S (see Sections V.H
and V.N of this document), firms must not establish a new traceability
lot code when they conduct other activities (e.g., shipping) for an FTL
food.
5. Statement Identifying a Point of Contact
    (Comment 325) One comment suggests that the final rule include a
requirement that entities have a ``qualified individual'' who can
perform the recordkeeping activities required under the rule. The
comment maintains that some businesses subject to the rule that create
or transform FTL foods do not use lot coding systems and rely on the
date the product was produced or a ``best by'' date. The comment
maintains that for such businesses, building their first lot code will
pose a significant challenge. But the comment notes that, unlike other
FSMA regulations (e.g., FSVP, preventive controls for human food), the
traceability rule has no requirement to designate a specific employee
and level of expertise to be responsible for a firm's traceability
system. The comment asserts that the rule constitutes the first time
specific traceability information will be required by a regulation,
which presents a difficult educational challenge because some firms
already collect more information than will be required under the final
rule, though possibly in different formats, while others will be
starting completely from scratch. The comment also maintains that, more
than any other FSMA rule, the compliance of downstream entities in the
supply chain is predicated on the understanding and ability of previous
entities in the supply chain to implement the rule, because downstream
entities must be able to collect correct and compliant information to
meet their own responsibilities. The comment questions how this will
occur without a developed and standardized curriculum to ensure
effective implementation of the requirements.
    (Response 325) We do not agree that it is necessary to codify in
the regulation a requirement that persons subject to the final rule
have a ``qualified individual'' with a specified level of expertise who
has studied a standardized curriculum. We do not believe it is
necessary to establish qualifications for individuals who conduct
traceability operations to ensure compliance with the subpart S
recordkeeping requirements, and developing a standardized curriculum
would be impractical because individual firms vary widely in their
approaches to traceability recordkeeping. However, we have revised
Sec.  1.1315(a) to specify (in Sec.  1.1315(a)(4)) that an entity's
traceability plan must include a statement identifying a point of
contact for questions regarding the entity's traceability plan and
records. As previously stated, the rule defines ``point of contact'' as
an individual having familiarity with an entity's procedures for
traceability, including their name and/or job title, and their phone
number. Thus, an entity subject to subpart S must have someone
available as a point of contact who is familiar with the firm's
traceability plan and traceability records. This means that firms will
have to employ or obtain the services of at least one person who
understands how the firm conducts its internal traceability procedures,
including how traceability information is received and/or provided to
its supply chain partners. We conclude that this requirement to
identify a point of contact will help ensure that traceability
information for FTL foods is made available to FDA and other supply
chain entities on a timely basis.
    (Comment 326) Several comments suggest that FDA can obtain
information necessary for traceback by contacting a firm's facility
registration contact. The comments suggest that FDA could communicate
this expectation to industry either through guidance in support of this
rule, guidance in support of facility registration renewal, or as part
of the facility registration process. The comments maintain that
contacting the facility registration contact would obviate the need for
firms in the supply chain to provide point of contact information to
customers, since FDA already has access to facility registration
information.
    (Response 326) We decline to specify that a firm's point of contact
for

purposes of the subpart S requirements must be its facility
registration contact. Although facility registration data may provide
information on points of contact for some firms subject to subpart S,
not every covered entity is required to register with FDA as a food
facility. For example, farms, RFEs, and restaurants are not required to
register with the Agency. Furthermore, a firm's facility registration
contact might not have knowledge of the firm's traceability program and
therefore would not be best positioned to respond to questions about
the program. As stated in Response 274, we have addressed concerns
about the privacy of points of contact by revising the definition of
``point of contact'' so that firms may provide the job title (instead
of the name) of their point of contact.
6. Farm Map
    In response to comments we received about the proposed requirement
(in Sec.  1.1325(a)) that those who grow FTL foods maintain records
linking the traceability lot code of the food to the growing area
coordinates for the food, we are deleting that requirement and
replacing it with a requirement that those who grow or raise an FTL
food (other than eggs) must include in their traceability plan a farm
map showing the location and name of each field (or, for aquaculture
farms, each container) in which the food on the FTL was grown or
raised, including geographic coordinates and any other information
needed to identify the location of each field (or, for aquaculture
farms, each container). (As stated in Section V.F of this document, we
had proposed to define ``growing area coordinates'' as geographical
coordinates (under GPS or latitude/longitude) for the entry point of
the physical location where the food was grown and harvested.) We
discuss the farm map requirements in response to the following comments
on the proposed requirement concerning growing area coordinates.
    (Comment 327) Many comments request the removal of growing area
coordinates as a KDE for the growing of an FTL food. The comments
maintain that GPS coordinates are susceptible to documentation error
due to misplaced decimal places or other recording errors. The comments
also assert that obtaining and maintaining growing area coordinates for
the entrances to fields where seed for sprouting is grown would place
an undue burden on small and mid-size farms, and ask that we clarify if
the proposed requirement applies to operations that grow sprouts. The
comments suggest several alternatives to the use of growing area
coordinates, including satellite printouts, field numbers, Farm Service
Agency records, mailing addresses, written directions, and GS1 US GLNs.
Some comments express concerns about scalability and privacy concerns
with the growing area coordinates requirement. A few comments seek
clarification on whether growing area coordinates must be shared with
trading partners.
    (Response 327) As discussed more fully in Section V.J of this
document, we have deleted from the final rule the proposed requirements
for persons who grow an FTL food, including the requirement to keep a
record of the growing area coordinates for each traceability lot of an
FTL food. However, we believe that geographic coordinates provide
important information for identifying the location where a food is
sourced. We also believe that geographic coordinates are accessible to
all farms. Therefore, Sec.  1.1315(a)(5) of the final rule specifies
that if an entity grows or raises a food on the FTL (other than eggs,
as discussed in Response 349), its traceability plan must include a
farm map showing the area in which the food is grown or raised. Except
with respect to aquaculture farms (discussed in Response 328), the farm
map must show the location and name of each field (or other growing
area) in which a food on the FTL is grown, including geographic
coordinates and any other information needed to identify the location
of each field or growing area (Sec.  1.1315(a)(5)(i)). The requirement
to maintain a farm map as specified in Sec.  1.1315(a)(5)(i) applies to
indoor growing operations (e.g., greenhouses, hydroponic farms), as
well as outdoor operations. We added the phrase ``or other growing
area'' to describe situations where the location in which a food is
grown is not a field. Like outdoor operations, indoor operations may
consist of multiple growing areas, in which case farm maps will be
particularly useful during an outbreak investigation to assist in
pinpointing the area where an implicated FTL food was grown. With
regard to the comment asking about sprout operations and sprout seed
operations, Sec.  1.1315(a)(5)(i) applies to anyone who grows or raises
a food on the FTL other than eggs (except it does not apply to
aquaculture farms, which are discussed below and in Sec.
1.1315(a)(5)(ii)). Because sprouts are on the FTL, this provision
applies to growers of sprouts. Seeds for sprouting, however, are not on
the FTL, so this provision does not apply to growers of seeds for
sprouting.
    With respect to the sharing of growing area coordinates with
trading partners, as discussed in Section V.J of this document, the
final rule requires harvesters and coolers of FTL foods to provide to
the initial packer of the food the location description for the farm
where the food was harvested, which can be done by providing either the
physical location address or geographic coordinates for the farm (in
addition to the other information identified in the definition of
``location description''). The final rule also requires harvesters of
FTL produce to provide 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. Because the
field name provided to the initial packer must match the field name
used by the grower, this requirement will allow FDA to connect the
information we obtain from the initial packer with the farm map that
the grower is required to maintain under Sec.  1.1315(a)(5), thus
enabling us to identify the specific field where the produce was grown.
We conclude that these requirements relating to the location of the
farm where the food was harvested and the name of the field from which
the food was harvested are essential to ensuring adequate traceability.
    (Comment 328) One comment supports the use of GPS coordinates to
identify pond-specific harvest of fish and to identify small-scale
aquaculture farms.
    (Response 328) We agree with the comment that this information is
important to accurately identify and locate aquaculture operations.
Therefore, Sec.  1.1315(a)(5)(ii) of the final rule specifies that for
aquaculture farms, the farm map required as part of the traceability
plan must show the location and name of each container (e.g., pond,
pool, tank, cage) in which the seafood on the FTL is raised, including
geographic coordinates and any other information needed to identify the
location of each container. Use of GPS could be one way in which
aquaculture farms could meet the requirement to document the relevant
geographic coordinates.
    (Comment 329) One comment expresses concern over the amount of
paperwork that would be necessary to maintain growing area coordinates
for multiple commodities over a long period of time.
    (Response 329) As previously stated, rather than keeping records on
the growing area coordinates for each traceability lot of FTL food
grown, the final rule requires entities that grow or

raise FTL foods to keep a farm map as part of their traceability plan.
Documenting the relevant field (or container) names and locations,
including the geographic coordinates, on the farm map might be a one-
time event and would only need to be repeated if the field or container
locations change, which should result in a reduced burden compared to
the proposed requirement on growing area coordinates.
    (Comment 330) One comment suggests that we reference the GPS
standard released in April 2020 that GPS coordinates must be accurate
to within 5 meters (3 meters longitude and 5 meters latitude).
    (Response 330) Although we recognize the importance of the GPS in
meeting requirements to record geographic coordinates of farms, because
the final rule does not use the term ``global positioning system,''
there is no need to reference any particular GPS standard in the rule.
    (Comment 331) Some comments ask for additional clarity regarding
how growing area coordinates would help identify fields on a farm. One
comment states that farms may have multiple points of entry or maintain
properties over multiple jurisdictions and suggests that physical
location may be more useful than growing area coordinates. One comment
maintains that the reference in the proposed rule to the geographical
coordinates of the field entrance does not provide sufficient
information about field location, and that without greater specificity,
entire farms rather than individual fields might be implicated in a
product recall. One comment asks whether a farm needs to assign names
to each field.
    (Response 331) As previously stated, the final rule deletes the
proposed requirement concerning growing area coordinates and replaces
it with a requirement for farms to include farm maps in their
traceability plans. The farm maps must show the location and name of
each field or container in which a food on the FTL is grown or raised,
including geographic coordinates and any other information needed to
identify the location of each field or container. Presenting this
information in the form of a map will provide a greater level of
specificity and visual perspective for each field or container on the
farm, because it will provide a fuller context to understand the size
and location of a field or container as compared to what would be
provided by a single set of geographic coordinates in isolation (i.e.,
not as part of a map). Additional information that may be provided,
such as adjacent road names or other identifying information, will help
position the farm in its geographic area and provide a better
understanding of the farm and where foods are grown or raised than the
physical location alone. In some cases, if the size of the farm is
small and there are only a few adjacent fields or containers on the
farm, it might be sufficient to specify only one set of geographic
coordinates.
    (Comment 332) One comment maintains that tracking a lot code to a
growing location using coordinates is complicated by transplanting.
    (Response 332) As stated in Response 327, we have deleted from the
final rule the proposed requirement for persons who grow an FTL food to
keep a record of the growing area coordinates for each traceability lot
of the food. The final rule states that growers need to maintain a farm
map showing the location and name of each field (or other growing area)
in which food on the FTL is grown, including geographic coordinates and
any other information needed to identify the location of each field or
growing area. If an FTL food is initially grown in one field and then
transplanted to another field, both fields must appear on the farm map,
because they are both fields in which an FTL food is grown.
    As previously stated, the harvester of an FTL food must provide
certain information to the initial packer, including the location
description for the farm where the food was harvested and (for
harvesters of produce) the name of the field or other growing area from
which the food was harvested. Where transplanting had occurred, the
harvester would only need to provide the name of the field from which
the food was harvested (not information on previous growing locations
of the transplanted food).
7. Deleted Requirement To Maintain Other Information Needed To
Understand Data
    We proposed to require firms to establish and maintain, as part of
their traceability program records, any other information needed to
understand the data provided within any records required by subpart S,
such as internal or external coding systems, glossaries, and
abbreviations (proposed Sec.  1.1315(a)(4)). On our own initiative, we
have determined that this information needed to understand data in a
firm's records is more relevant in the context of an Agency request to
review a firm's subpart S records than as a part of a firm's
traceability plan. Therefore, as discussed in Section V.R of this
document, Sec.  1.1455(c)(1) of the final rule specifies that an entity
must make all records required under subpart S available to an
authorized FDA representative, upon request, within 24 hours (or within
some reasonable time to which FDA has agreed) after the request, along
with any information needed to understand these records, such as
internal or external coding systems, glossaries, abbreviations, and a
description of how the records provided correspond to the information
required under subpart S. Consistent with this determination, we have
deleted the proposed requirement to keep records of information needed
to understand the data in subpart S records from Sec.  1.1315.
8. Updating and Maintaining the Traceability Plan
    We proposed to require that covered entities must retain the
records required under proposed Sec.  1.1315(a) (i.e., traceability
program records) for 2 years after their use is discontinued (e.g.,
because the entity changes the records in which it maintains the
required information, updates the list of foods on the FTL it ships, or
changes its procedures for establishing and assigning traceability lot
codes) (proposed Sec.  1.1315(b)).
    On our own initiative, we are revising Sec.  1.1315(b) to reflect
changes made to Sec.  1.1315(a) and to make explicit what was implied
by the parenthetical in the proposed rule, i.e., that we expect a
firm's traceability plan to reflect its current practices. Section
1.1315(b) of the final rule therefore states that entities must update
their traceability plan as needed to ensure that the information
provided reflects their current practices and to ensure that they are
in compliance with the subpart S requirements. Consistent with the
proposed rule, Sec.  1.1315(b) further specifies that firms must retain
their previous traceability plan for 2 years after they update their
plan.

H. Assignment of Traceability Lot Codes (Sec.  1.1320)

    We proposed to require entities to establish and assign a
traceability lot code when they originate, transform, or create a food
on the FTL (proposed Sec.  1.1320(a)). We further proposed that, except
as specified elsewhere in subpart S, a person may not establish a new
traceability lot code when they conduct other activities (such as
shipping or receiving) in the supply chain for an FTL food (proposed
Sec.  1.1320(b)). As discussed below, to align with changes we are
making to CTE requirements, we have revised the circumstances under
which persons are required to assign a traceability lot code, while
making only minor changes to proposed Sec.  1.1320(b).

    (Comment 333) One comment recommends that we delete the requirement
for farmers and harvesters to create lot codes. The comment maintains
that retaining this requirement would impose financial hardship, while
deleting it would eliminate duplication of regulations imposed by
states. Several comments suggest that entities responsible for packing
RACs such as produce, eggs, and seafood should be responsible for
assigning a traceability lot code to the food. The comments maintain
that these entities are better positioned in the supply chain to assign
lot codes, and are more likely to have systems in place for storing
KDEs for events like growing and harvesting.
    (Response 333) We agree with the comments that entities that pack a
RAC for the first time generally are better positioned than growers and
harvesters to assign a traceability lot code to the food. It is the
packed form of the RAC that is distributed throughout the supply chain,
and RACs often are harvested into temporary holding containers in a
process that does not lend itself well to assigning traceability lot
codes. In recognition of this, we have revised the proposed CTE
requirements to delete the requirement for growers of FTL foods to
establish a traceability lot code (see Section V.J of this document)
and to add requirements applicable to the initial packers of RACs other
than food obtained from a fishing vessel (see Section V.K of this
document), including a requirement to assign a traceability lot code
for such food. Regarding food obtained from a fishing vessel, we have
identified the first land-based receiver of the food as the entity best
positioned to assign a traceability lot code for the food (see Section
V.K of this document). In accordance with these and other changes to
the CTE requirements, Sec.  1.1320(a) of the final rule specifies that
a person must assign a traceability lot code when they initially pack a
RAC other than a food obtained from a fishing vessel, perform the first
land-based receiving of a food obtained from a fishing vessel, or
transform a food.
    (Comment 334) One comment requests that all shellfish growers and
harvesters be exempt from the requirement to assign or keep lot codes
because most shellfish growers and harvesters would be exempt from
subpart S, since they produce less than $25,000 in shellfish annually.
    (Response 334) As previously discussed, Sec.  1.1305(f) of the
final rule exempts from subpart S raw bivalve molluscan shellfish that
are: (1) covered by the requirements of the NSSP; (2) subject to the
requirements of part 123, subpart C, and Sec.  1240.60; or (3) covered
by a final equivalence determination by FDA for raw bivalve molluscan
shellfish. This means that nearly all raw bivalve molluscan shellfish
will not be subject to the rule. However, for shellfish growers and
harvesters that are not exempt from the rule under Sec.  1.1305(f) or
any other exemption (e.g., the exemption for certain small producers of
RACs other than produce or shell eggs in Sec.  1.1305(a)(3)), we
conclude that it would not be appropriate to exempt them from the
requirements to assign and keep lot codes as may apply to them under
subpart S.
    (Comment 335) Several comments assert that firms should be required
to link the incoming lot code of an FTL food to an outgoing lot code at
every node in the distribution chain, and that each entity in the chain
be permitted to assign their own lot code to the FTL food in accordance
with their internal traceability protocols. Some comments maintain that
such a system would be particularly helpful in the case of imported
products, where it might not be known at the beginning of the supply
chain that the product will eventually be exported to the United
States; the comments contend that such an approach would be consistent
with Codex recommendations regarding product tracing. The comments
assert that this would effectively constitute ``one-up, one-back''
tracing via lot code.
    (Response 335) We do not agree that firms should be allowed to
create a new traceability lot code for an FTL food whenever they deem
it appropriate. Firms that wish to do so may assign their own internal
lot codes to FTL foods for the purposes of internal tracing, but they
must comply with the subpart S requirement to keep the traceability lot
code unchanged except under specified circumstances. As discussed in
the preamble to the proposed rule (85 FR 59984 at 60006), assigning a
new traceability lot code for a food that has not been transformed can
lead to confusion that can hinder traceback and traceforward efforts
during investigation of foodborne illness outbreaks.
    The use of traceability lot codes that remain unchanged as the food
passes through supply chain nodes such as distribution centers will
allow us to skip these nodes, at least initially, in a traceback
investigation and more quickly identify the firm that initially packed,
first received on land, or transformed the food, because firms that
receive FTL foods will be required to keep a record of the traceability
lot code and the traceability lot code source. For these reasons, we
conclude that it is appropriate to specify, in Sec.  1.1320(b) of the
final rule, that new traceability lot codes must not be established
when conducting activities other than those specified in Sec.
1.1320(a), except as specified otherwise in subpart S. (As discussed in
Sections V.K and V.N of this document, the final rule requires firms to
assign a traceability lot code upon receipt of an FTL food from a
person to whom subpart S does not apply, if one has not already been
assigned (see Sec.  1.1345(b)).)
    As discussed in Response 525, we believe the rule conforms to the
Codex principles for traceability (CAC/GL60-2006), and while the final
rule goes beyond one-up, one-back tracing, this is not in conflict with
Codex principles. Regarding the concern about imported products for
which it might not be known at the beginning of the supply chain that
the product will eventually be exported to the United States, as stated
in Response 103, U.S. importers will need to work with their foreign
suppliers to ensure they are aware of the subpart S traceability
requirements. We note that many existing FDA regulations include
requirements for imported foods, including requirements regarding the
beginning of the supply chain (for example, requirements relating to
the growing of produce in the produce safety regulation), and we
believe it is reasonable to expect that foreign entities will be able
to comply with the final rule. We also note that many foreign entities
that produce food that is ultimately exported to the United States
already have procedures in place for identifying such food, and the
final rule provides flexibility to allow firms to rely on existing
procedures and information to meet the rule's requirements.
    (Comment 336) One comment asserts that because supply chain systems
are not fully interoperable, a traceability lot code designated at the
beginning of the supply chain may not be compatible with downstream
systems. Therefore, the comment maintains that each covered entity
should be able to establish their own traceability lot codes, provided
one-up, one-back traceability is maintained.
    (Response 336) We do not agree with the comment. As previously
stated, limiting the circumstances under which a traceability lot code
may be assigned to a product increases the chances that we will be able
to rapidly identify and contact the source of a food when conducting an
outbreak investigation. This use of traceability lot codes (and
traceability lot code source information, as discussed in Section I.B
of this

document) is central to subpart S because it enables traceability that
is more efficient than what can be attained through one-up, one-back
tracing. Allowing firms to assign new traceability lot codes to foods
at any point in the supply chain would undermine this key element of
subpart S and would create obstacles to efficient traceability. While
we agree with the comment that supply chain systems are not fully
interoperable, we do not think full interoperability is necessary to
accommodate a variety of incoming traceability lot codes.
    (Comment 337) One comment asserts that the prohibition in proposed
Sec.  1.1320(b) against assigning traceability lot codes other than in
the specified circumstances violates section 204(d)(1)(E) of FSMA,
which states that we 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. The comment maintains
that many covered entities have functioning, efficient traceability
systems that assign internal lot codes to incoming product that allows
the connection of incoming product to outgoing product, and not
allowing the use of these systems instead of a traceability lot code
that cannot be changed means that information must be duplicated to
comply with the rule.
    (Response 337) We do not agree that limiting the circumstances in
which a traceability lot code may be assigned means that firms must
create and maintain duplicate records. Covered entities are free to
continue to use tracing systems that assign internal lot codes to
products as they come into their systems for internal tracing purposes,
but they are not required to do so. To the extent that a firm chooses
to assign internal lot codes to FTL foods they receive, and to keep
records of those internal lot codes, the requirement to maintain the
existing traceability lot code is not a duplication of those records.
    As previously discussed, for the rule to improve traceability as
intended, the circumstances under which traceability lot codes may be
assigned must be limited to allow the applicable traceability lot code
to continue to be linked to an FTL food as the food moves through the
supply chain, which will enable us to more quickly trace the food. We
note that firms that assign traceability lot codes (in accordance with
Sec.  1.1320) may opt to use their existing internal lot coding systems
in assigning the traceability lot codes.
    (Comment 338) One comment suggests that we revise proposed Sec.
1.1320(b) to state that a person ``shall not'' rather than ``may not''
establish a new traceability lot code except under circumstance stated
elsewhere in subpart S.
    (Response 338) We agree that Sec.  1.1320(b) should be changed to
more clearly state that assignment of a traceability lot code except
under the specified circumstances is prohibited. Therefore, we are
revising Sec.  1.1320(b) to state that except as specified otherwise in
subpart S, a person ``must not'' establish a new traceability lot code
when they conduct other activities (e.g., shipping) for a food on the
FTL.
    (Comment 339) One comment asks that we clarify whether a new
traceability lot code must be assigned by a third-party warehouse that
is within the control of the manufacturer.
    (Response 339) Under Sec.  1.1320(a) of the final rule, a firm must
assign a traceability lot code to an FTL food when it does any of the
following: initially packs a RAC other than a food obtained from a
fishing vessel, performs the first land-based receiving of a food
obtained from a fishing vessel, or transforms a food. Unless the
warehouse is engaging in one of those activities (or unless it received
the food from an entity that is not subject to subpart S, as discussed
in Section V.N.2 of this document), it would not be required to assign
a traceability lot code to the food, and indeed it would not be
permitted to do so under Sec.  1.1320(b).
    (Comment 340) Some comments suggest that the first receiver of
shellfish (under proposed Sec.  1.1330) should assign the traceability
lot code rather than the shellfish harvester or aquaculture farm. The
comments assert that many shellfish harvesters and small farms are not
computer-literate and would either not be able to comply with the
requirement to assign a traceability lot code or would be exempt from
the rule.
    (Response 340) We agree with the comments that harvesters of
shellfish are often not the best-positioned entity in the supply chain
to assign a traceability lot code. As stated above, we have deleted the
proposed requirement for ``originators'' of FTL foods (i.e., entities
that grow, raise, or catch a food) to assign a traceability lot code to
the food. Instead, Sec.  1.1320(a) specifies that a traceability lot
code must be assigned either by the initial packer, for a food not
obtained from a fishing vessel (which could include aquacultured
shellfish); or else by the first land-based receiver, for a food
obtained from a fishing vessel. Note that most raw bivalve molluscan
shellfish are exempt from subpart S (see Section V.E.7 of this
document).
    (Comment 341) One comment asserts that the proposed KDEs would not
be necessary if lot codes were required to be printed on all product
packaging and related documents for every transaction. Some comments
assert that an important precondition for the rule is the
identification of physical product with the traceability lot code using
industry standards such as those used in the PTI.
    (Response 341) The final rule does not require that the
traceability lot code for a food appear on the food's labeling or
packaging. However, we recognize the potential value of physically
identifying foods with the traceability lot code, and we welcome the
use of industry-supported standards and best practices, such as those
in the PTI, in meeting subpart S requirements, including those
regarding assignment and communication of traceability lot codes.
    (Comment 342) Many comments assert that the proposed rule would
impose a case-level tracking requirement throughout the supply chain,
in violation of section 204(d)(1)(L)(iii) of FSMA, because it would
require distributors to maintain and send shipping KDEs linked to the
specific traceability lot codes of the products in each shipment. The
comments maintain that distributors receive shipments with multiple lot
codes from their suppliers that would have to be tracked as they
fulfill orders for their customers, especially in situations where a
mixed pallet is being shipped or smaller quantities of products are
being sold; the comments claim that tracking to the case level would be
the only way to know the traceability lot code for each case sent to a
customer. The comments also maintain that shipments to RFEs move not by
an entire traceability lot, but rather by case count. The comments
further assert that in circumstances where a pallet-level barcode with
a case-level GTIN and applicable date and batch/lot numbers for
products on the pallet is not available, distribution centers would
need to break down the pallets to record the case-level information. In
addition, the comments assert that a case-level tracking requirement is
unnecessary because current tracing systems, which link product through
POs, BOLs, or other reference records, is equally effective when
conducting traceback activities. The comments also suggest that the
proposed rule would require entities to place labels on every case,
which they maintain would be costly. The comments contend that
distribution centers using voice picking would not be able to track
individual cases and

would need to shift to case-scanning technology. The comments also
claim that in situations where product types are not conducive to paper
labeling, firms may need to switch to a reusable plastic container,
resulting in additional costs and transportation expenses. In addition,
the comments maintain that when an RFE receives a pallet with products
from different traceability lots, the RFE would have to keep different
sets of KDEs for the same food item if they represent different
traceability lots, which would create confusion and complexity. The
comments also state that sometimes cases fall off pallets, which can
affect traceability.
    (Response 342) We disagree with the comments that the rule requires
case-level tracking. For each CTE performed by a covered entity, the
final rule requires the applicable KDEs to be maintained for each
traceability lot of an FTL food, linked with a traceability lot code.
We have provided flexibility for how a firm identifies a traceability
lot; a firm could define a lot as a case, a pallet, a day's production,
or some other amount of product. We recognize that entities such as
distribution centers are generally not allowed to assign a new
traceability lot code under Sec.  1.1320, and therefore cannot control
the size of the traceability lot. This can lead to situations where a
single incoming traceability lot gets broken up and shipped to multiple
destinations, or to multiple traceability lots being combined into a
single pallet or a single shipment. Subpart S does not require case-
level tracking in such situations, and we think the final rule provides
adequate flexibility for firms to decide how to manage these
situations, depending on their individual practices.
    One reason why the rule requires KDEs in addition to the
traceability lot code is that we recognize that in some situations,
parts of a single traceability lot might end up in multiple places. If
an entity such as a distribution center breaks up a single traceability
lot and ships the product to multiple locations, each shipment will
have its own set of KDEs associated with it, and the combination of the
traceability lot code and the information regarding the shipping event
(e.g., information about the food's recipient) will provide a
sufficiently descriptive record of that event despite the fact that
another portion of the same traceability lot (with the same
traceability lot code) was shipped elsewhere. This approach does not
constitute case-level tracking, because there is no requirement to have
case identifiers to track which cases are sent to which destination.
Conversely, if an entity such as a distribution center receives several
small traceability lots of the same product, and therefore needs to
combine multiple lots into a single shipment, the records for that
shipping event would need to be specific to each traceability lot;
however, this too does not constitute case-level tracking, because
records would not need to be kept to uniquely identify each individual
case. We recognize that if an entity chooses to identify a single case
as an entire traceability lot, or to divide a traceability lot into
single-case shipments, the result would be recordkeeping for individual
cases. However, this would be due to the decisions made by the firm,
not to any requirement to engage in case-level tracking.
    Regarding the statement that other tracing systems linking products
through POs or BOLs are equally effective, we note that those systems
can be used as long as such reference documents enable a firm to meet
the requirements of subpart S, including linking the traceability lot
code of an incoming FTL food to the traceability lot code of an
outgoing FTL food. For some points in the supply chain (e.g., those
entities performing only shipping and receiving), the traceability lot
code will remain the same for the incoming and outgoing food.
    The final rule does not require firms to label every case of FTL
food (with paper labels or otherwise). However, we realize that for
some businesses, this might be the most efficient way to keep track of
the quantity and unit of measure of a particular traceability lot that
has been received or is being shipped to a customer. Alternate business
practices are available, such as labeling a slot or bin in a warehouse
with a traceability lot code if all the cases in that holding area have
the same traceability lot code.
    As comments note, when cases lack any identifying information that
links to a traceability lot code and there are multiple traceability
lots of the same FTL food, such as in a warehouse, if one case falls
off a pallet or gets separated, it could be difficult to identify which
traceability lot the case belongs to. Individual firms can decide how
to manage this risk. For example, a firm might take steps to prevent
individual cases from getting accidentally separated from their
pallets; firms might decide to label each individual case; or firms
might decide that if a case is separated, they will perform an
inventory of all identical product on hand to determine which
traceability lot is missing a case.
    (Comment 343) Some comments request that FDA allow distribution
centers to maintain and send KDEs related to multiple traceability lot
codes on a pallet, or a new traceability lot code assigned by the
distribution center representing the traceability lot codes on a
pallet, rather than the exact traceability lot codes received from the
previous source.
    (Response 343) We decline to make this change to allow distributors
to create new traceability lot codes for foods they do not transform,
or to create records that do not distinguish between different
traceability lots on a pallet. Except when a distributor receives an
FTL food from a person to whom subpart S does not apply (see Sec.
1.1345(b)), a distributor generally would not be permitted to establish
a new traceability lot code for a food under Sec.  1.1320(b). An
important part of the subpart S requirements is that covered entities
must keep a record of the traceability lot code and information on the
traceability lot code source or a source reference for each
traceability lot of an FTL food they handle and must pass that
information along when they ship the food. The final rule does not
prescribe how an entity such as a distribution center must maintain
this information and provide it to the subsequent recipient, but it
should be clear which traceability lots the distribution center handled
and which specific traceability lots were included in the shipment. If
the information maintained by the distribution center or provided to
the subsequent recipient is ambiguous, the information provided to FDA
may be unclear, which could slow our investigation.
    (Comment 344) Some comments ask that flexibility be incorporated
into lot-level identification so that a packer may assign a
traceability lot code if the grower has not done so or if a RAC is
commingled between harvesting and processing.
    (Response 344) As previously stated, we have removed the proposed
requirement for growers to assign traceability lot codes. Instead,
Sec.  1.1320(a) of the final rule specifies that the initial packer of
a RAC other than a food obtained from a fishing vessel must assign a
traceability lot code to the newly packed food. If a RAC is commingled
before it is initially packed, the initial packer's records will
reflect that the traceability lot is associated with multiple fields
and/or multiple farms, but there is no requirement to track which parts
of the lot come from which fields or farms. If a non-produce RAC is
commingled after harvesting and before processing, it may be partially
exempt from subpart S under Sec.  1.1305(h) (see Section V.E.9 of this

document). For food obtained from a fishing vessel, see the discussion
of commingling in Response 208; for eggs, see the discussion of
commingling in Response 206.
    (Comment 345) One comment expresses concern that a lack of
specificity regarding traceability lot codes and the requirement to
pass traceability lot codes along the supply chain may prove to be
burdensome for small entrepreneurs.
    (Response 345) We disagree with the comment. The assignment of
traceability lot codes and the provision of these codes (along with
other KDEs for a food) to downstream entities in the supply chain of a
food are critical components of recordkeeping requirements that will
enable the Agency to more swiftly and efficiently conduct product
tracing during an investigation of a foodborne illness outbreak or a
recall. We are uncertain as to what aspect of traceability lot codes
the comment believes lacks specificity. We believe that the rule
provides appropriate flexibility to firms regarding the form and
content of traceability lot codes and the manner in which they are
assigned to FTL foods. However, because we recognize that meeting the
subpart S requirements may be more burdensome for smaller firms, the
final rule includes exemptions for certain types of smaller entities,
including small producers and small RFEs and restaurants, as discussed
in Sections V.E and V.R.3 of this document.
    (Comment 346) One comment asks if FDA needs to be able to tie
traceability lot codes to a specific production line or facility.
    (Response 346) The rule does not require that firms construct
traceability lot codes such that they identify particular production
lines or facilities. However, consistent with the definition of
``traceability lot code,'' the traceability lot codes that a firm
assigns must be able to uniquely identify a traceability lot within the
firm's records. Therefore, a firm might choose to, but is not required
to, assign traceability lot codes that reflect production on a
particular production line or at a particular facility. Furthermore, we
note that subpart S contains requirements relating to the traceability
lot code source, which is the place where a food was assigned a
traceability lot code. For many of the CTEs, records must be maintained
that contain either the location description for the traceability lot
code source or the traceability lot code source reference. This
information allows FDA to identify the place where a specific
traceability lot code was assigned, which will often be the facility
where the food was manufactured or otherwise transformed (see Response
265). There is no requirement that this information enable FDA to
identify the specific production line where the food was manufactured.

I. Critical Tracking Events Framework

    At the core of the subpart S traceability recordkeeping
requirements are provisions requiring entities that manufacture,
process, pack, or hold FTL foods to keep and, at times, provide to
immediate subsequent recipients of food certain information related to
CTEs in the food's supply chain. The proposed rule included growing,
transformation, creating, shipping, and receiving (including
requirements for the ``first receiver'' of a food) as CTEs for which
KDEs must be maintained. As discussed previously, we received many
comments concerning the proposed CTEs, particularly the requirements
associated with the first receiver CTE and which entities in the supply
chain are best suited to assigning lot codes to FTL foods. In response
to these comments, which we discuss below and in the following sections
concerning specific CTEs, we have made several changes in the final
rule to the CTE framework.
    As discussed in Section V.J of this document, many comments
maintain that lot codes are often assigned when a harvested food is
packed for distribution into commerce rather than during the growing
phase. We agree and therefore have placed the responsibility for the
assignment of traceability lot codes for RACs not obtained from a
fishing vessel on the initial packer of such food. We are deleting
entirely the proposed CTE for growing an FTL food, which included
requirements to assign traceability lot codes, document growing area
coordinates for each traceability lot, and document particular KDEs for
sprouts. Instead, as previously discussed, the final rule requires
persons who grow or raise an FTL food (other than eggs) to maintain, as
part of their traceability plan, a farm map showing the area, including
geographic coordinates, in which they grow or raise the FTL food. The
specific information related to sprouts is now included in the
requirements for the initial packing CTE (see Section V.K of this
document).
    The proposed provisions for the first receiver CTE would have
placed certain recordkeeping requirements on the first person (other
than a farm) who purchases and takes physical possession of an FTL food
that has been grown, raised, caught, or (in the case of a non-produce
commodity) harvested. As previously discussed, several comments express
confusion regarding the first receiver concept and suggest that the
proposed first receiver requirements would make more sense as
requirements for the person who initially packs an FTL food, because
packers often have much of the information that would have been
required of first receivers. Comments also indicate concern than an
entity could be a first receiver and may not know it, including
entities that would not typically have the required information on
growing, harvesting, cooling, and packing, such as distributors and
third-party warehouses.
    In response to these comments, we have replaced the proposed
requirements of the first receiver CTE with requirements for entities
that initially pack or (in the case of food obtained from a fishing
vessel) perform the first land-based receiving of certain FTL foods.
This places recordkeeping responsibilities on the entity performing a
certain activity (e.g., initial packing) and therefore reduces
confusion about the type of entity that is required to maintain these
KDEs. We had proposed separate requirements for first receivers of (1)
seafood products on the FTL obtained from a fishing vessel and (2) all
other FTL foods. Similarly, the final rule establishes separate
requirements for the CTE of the initial packing of RACs other than food
obtained from a fishing vessel (Sec.  1.1330) and requirements for the
CTE of the first land-based receiving of a food obtained from a fishing
vessel (Sec.  1.1335).
    We also received comments requesting clarity as to what activities
constitute ``transformation'' rather than ``creation'' of an FTL food
and asking that the requirements for the transformation and creating
events be combined into a single CTE. As discussed in Section V.O of
this document, we agree with the comments and have merged the
requirements for the creating CTE with the requirements for the
transformation CTE in Sec.  1.1350 of the final rule. This action
simplifies the requirements by removing the distinction between
production of an FTL food with an ingredient(s) on the FTL (e.g.,
bagged salad) and production of an FTL food without ingredients on the
FTL (e.g., peanut butter).
    Although the shipping and receiving CTEs in the final rule
(Sec. Sec.  1.1340 and 1.1345, respectively) are similar to those we
had proposed, we have made some changes to the proposed requirements
for these CTEs. First, we have deleted from the shipping CTE the
proposed requirement for farms to provide certain information on the
production of a food to the immediate subsequent recipient of the food
they ship. Instead, to ensure

that firms that conduct the initial packing of RACs (other than food
obtained from fishing vessels) have this important information, we have
adopted requirements for harvesters and coolers of such RACs to keep
certain records of their activities and provide that information,
including information about the farm where the food was harvested, to
the initial packer. In addition, we have revised the shipping and
receiving CTEs to specify that they do not apply to shipment or receipt
of a food (if the food is a RAC not obtained from a fishing vessel)
that occurs before the food is initially packed, or to the receipt of a
food by the first land-based receiver of the food (if the food is
obtained from a fishing vessel). Finally, in response to comments about
what requirements apply when a firm receives food from an entity that
is exempt from subpart S, we have revised the receiving CTE (as well as
the initial packing CTE) to specify certain KDEs that must be kept when
a receiver or initial packer receives food from a person to whom
subpart S does not apply.
    We respond to certain general comments on the proposed CTE
framework in the following paragraphs.
    (Comment 347) Some comments express support for FDA specifying
KDEs.
    (Response 347) We agree with the comments that support the rule's
framework of KDEs organized by CTEs. We believe that this framework
forms the foundation for effective and efficient tracing and clearly
communicates the information that FDA needs to perform such tracing.
    (Comment 348) One comment maintains that growing fresh produce in a
controlled environment is fundamentally different than growing fresh
produce outdoors in a field. The comment requests clarification of the
difference between the growing, transforming, and creating CTEs for an
indoor produce grower who grows, packs, and processes produce.
    (Response 348) We do not agree that growing produce in a controlled
environment differs fundamentally from growing produce outdoors
regarding the general level of safety risk or the type of recordkeeping
requirements that are appropriate for facilitating traceability. As
previously stated, we have incorporated the proposed requirements
applicable to creating an FTL food into the transformation CTE in Sec.
1.1350 of the final rule, and we have eliminated the proposed CTE for
growing an FTL food (although, as with farms that grow produce
outdoors, indoor produce farmers will have to establish a traceability
plan that includes a farm map in accordance with Sec.  1.1315 of the
final rule). If an indoor produce farmer harvests and/or cools the
produce, the requirements in Sec.  1.1325 of the final rule will apply.
If an indoor produce farmer packs the produce, it will be required to
comply with the requirements applicable to initial packers under Sec.
1.1330 of the final rule, and it would be required to maintain shipping
records for its distribution of the packed produce in accordance with
Sec.  1.1340. As discussed in Section V.U of this document, to help
covered entities understand their responsibilities under the rule, we
intend to provide communication and outreach materials that will
provide examples of required records for different supply chain
entities for specific FTL foods.

J. Records of Harvesting and Cooling (Sec.  1.1325)

    As discussed in Section V.I of this document, the proposed rule
included requirements for persons who grow an FTL food to establish and
maintain records containing and linking the traceability lot code of
the food to the growing area coordinates for the food (proposed Sec.
1.1325(a)). (Proposed additional requirements applicable to growers of
sprouts are discussed in Section V.K of this document.) Proposed Sec.
1.1350(b)(2) would have required farms to send information about the
origination, harvesting, cooling, and packing of a food when shipping
the food, while proposed Sec.  1.1330 would have required the first
receivers of food to maintain a record of this information.
    In response to many comments asserting that these proposed
requirements would impose significant recordkeeping burden on farms and
do not align with current industry practices (including with respect to
the assignment of lot codes), we have made several changes to the
requirements as they relate to the information about the growing,
harvesting, cooling, and packing of FTL foods. As previously discussed,
we have removed the requirement for growers to assign traceability lot
codes. Instead, the final rule specifies that traceability lot codes
must be assigned when a food is initially packed or (in the case of
food obtained from a fishing vessel) when it is first received on land,
and also when the food is transformed. As previously discussed, we have
deleted the proposed growing CTE requirements (including the
requirement to maintain growing area coordinates for each traceability
lot of a food) and replaced them (in part) with requirements for those
who grow or raise an FTL food (other than eggs) to keep a farm map as
part of their traceability plan. Under the final rule, some farms will
only need to maintain a traceability plan and will not have additional
KDE requirements. Finally, to ensure that the initial packer of a RAC
has information about the farm where the RAC was grown along with
information on the harvesting and cooling of the RAC, Sec.  1.1325 of
the final rule establishes certain recordkeeping and sending
requirements for persons who harvest or cool RACs, as discussed in
response to the following comments on the growing, harvesting, and
cooling of foods.
    (Comment 349) One comment expresses concern about the requirement
for growers to record the growing area coordinates for each harvested
traceability lot of food under proposed Sec.  1.1325(a). The comment
states that its farm grows many different crops that are very near each
other and that are rotated annually. The comment estimates that the GPS
technology required to comply would cost $1,000 to $3,000, representing
a significant percentage of the farm's revenue (which the comment
states may be less than $25,000 in some years). The comment asserts
that the growing CTE requirement is better suited for larger farms that
do not rotate crops and have more financial resources and staff.
    (Response 349) We note initially that, as discussed in Section
V.E.2 of this document, the final rule exempts from subpart S certain
small producers, including produce farms that make less than $25,000
annually in sales of produce (see Sec.  1.1305(a)). Furthermore, as
stated above, the final rule deletes the requirements for growers in
proposed Sec.  1.1325. Under Sec.  1.1315(a)(5) of the final rule,
farms that grow or raise a food other than eggs are required to keep,
as part of their traceability plan, a farm map showing (for non-
aquaculture farms) the location and name of each field (or other
growing area) in which they grow a food on the FTL. The map must
include geographic coordinates and any other information needed to
identify the location of each field or growing area. In the
circumstances described in the comment, a farm could maintain a map
showing all the fields or growing areas on the farm and labeling them
by name, with sufficient geographic coordinates to identify the
location of each field or growing area. The map would not have to be
altered to show the rotation of crops, because records maintained by
the harvester will identify what food was harvested from a specific
field on a specific day. Therefore, creation of the farm map could be a
one-time action

unless the location or names of fields or growing areas change.
    (Comment 350) Several comments recommend that the ``growing''
requirements in proposed Sec.  1.1325 should be replaced with
``harvesting'' requirements to reflect the step in the process where
tracing begins. Alternatively, the comments suggest that harvesting
should be a separate CTE, in addition to growing, where the lot code is
assigned.
    (Response 350) We agree with the comments that harvesting should be
a separate CTE, although not an event at which a traceability lot code
should be assigned. As previously discussed, we have deleted the
growing and first receiver CTEs. Under Sec.  1.1320(a) of the final
rule, an entity must assign a traceability lot code when it initially
packs a RAC other than a food obtained from a fishing vessel, performs
the first land-based receiving of a food obtained from a fishing
vessel, or transforms a food. We have determined that initial packers
are better suited to assigning traceability lot codes than growers of
RACs. However, we also believe that for initial packers to be able to
maintain the records of harvesting and cooling of RACs that we need
them to make available to us in an outbreak investigation, the rule
must require that certain entities provide the initial packers with
this information. Although the proposed rule (under Sec.  1.1350(b)(2))