As such, freezing finfish or seafood would not be considered a change
such that the food is no longer on the FTL, so frozen finfish or
seafood would not be exempt from the subpart S requirements.
    (Comment 28) One comment asserts that additional recordkeeping
requirements are unnecessary for foods containing FTL foods as
ingredients because processors already keep records under the
preventive controls for human food regulation and the FSVP regulation,
which require documentation of application of a kill step and
verification of suppliers. In addition, the comment maintains that food
companies still have to keep records for the immediate previous source
and immediate subsequent recipient of the food under subpart J.
    (Response 28) While many food companies are required to keep
records under subpart J documenting the immediate previous source and
immediate subsequent recipient of their food, FSMA directed FDA to
develop a regulation requiring additional traceability records for
certain foods beyond what FDA already requires under subpart J. We
recognize that food processors also must keep records under other
regulations, but many of those records are for purposes other than
traceability. For records required under subpart S, Sec.  1.1455(f)
specifies that firms may use records kept for other purposes and do not
have to duplicate records (see Section V.R.3 of this document). For
example, we anticipate that many manufacturers/processors would be able
to use records required under existing regulations, such as those
requiring documentation of monitoring of a preventive control (see 21
CFR 117.190(a)(2)) or documentation of thermal processing of low-acid
canned foods (LACF) (see 21 CFR 113.100), to meet the requirement in
Sec.  1.1305(d)(3)(ii) to document application of the kill step to a
food.
    (Comment 29) One comment requests that we exclude foods from the
final rule for which the Harmonized Commodity Description and Coding
System does not provide sufficient classification of the food because
it would be too confusing, particularly for trading partners, to
clearly identify the food on the FTL if there is not a corresponding
code in that system. Another comment suggests that we use the
Harmonized Commodity Description and Coding System to provide
additional clarity on the foods on the FTL.
    (Response 29) We decline the comment's suggestion to exempt from
the final rule foods that are insufficiently classified under the
Harmonized Commodity Description and Coding System. We believe the FTL
issued with the final rule (Ref. 19) provides sufficient information
for firms to know whether a particular food is on the FTL. While
Harmonized Commodity Description and Coding System codes are typically
used for tariff and not food safety purposes, we recognize that in some
cases providing additional information on FTL foods using
classification systems used by importers could be useful. We will
explore ways to provide additional guidance for importers as needed
regarding identification of foods on the FTL.
c. Changing the Form of an FTL Food
    (Comment 30) Many comments request clarification on the version of
the food that is covered by the proposed rule and whether a fresh
version of an FTL food would be considered an ingredient in a dried or
frozen version of the food and be covered, or if the dried or frozen
version of the food would not be considered an FTL food. The comments
note that the Model contains separate commodity designations for some
frozen foods such as frozen fruits and frozen vegetables. If the dried
or frozen version is covered by the rule, the comments ask for
clarification on which KDEs would apply to the food. The comments
maintain that including on the FTL these foods that have changed their
form would result in coverage of numerous foods that do not present the
same public health risk as listed foods and would increase the rule's
economic and resource burden on covered entities.
    (Response 30) We have clarified the FTL in response to the
comments. For foods that are designated as ``fresh'' on the FTL, if the
form of the food is no longer fresh and has been changed (i.e., through
freezing, drying, or another change in the form of the food), then the
food would no longer be an FTL food. For example, frozen spinach,
frozen cut mangoes, dried peppers, or dried herbs would not be covered
by the rule if only the fresh form is listed on the FTL. The person
changing the FTL food such that it is no longer on the FTL would need
to maintain receiving records of the FTL food but would not be required
to maintain subpart S records for its subsequent handling of the food
(e.g., transformation and shipping), and subsequent recipients of the
food would not have to maintain records under the rule.
    However, as discussed in Response 75, the commodities on the FTL
related to finfish and seafood include both the fresh and frozen forms
of those products. As such, freezing finfish or seafood would not be
considered a change such that the food is no longer on the FTL, and
frozen finfish and seafood are therefore covered by the final rule.
    We believe our approach to this issue is appropriate because of how
foods are categorized within the Model. For example, the Model includes
several commodity designations that could include peppers (e.g.,
peppers (fresh), frozen vegetables, dried vegetables), but it is the
fresh peppers that had a risk score high enough to be included on the
FTL. Frozen vegetables and dried vegetables did not have a risk score
that

placed them on the FTL (see Response 26 for a description of the method
by which foods on the FTL were determined).
d. Clarify Foods on the FTL
    (Comment 31) Several comments express appreciation for the
additional clarification FDA provided on the FTL on January 11, 2021,
and request that we include those clarifications in the final rule.
Many comments ask that we provide additional clarity and specificity in
describing the foods on the FTL, maintaining that this would reduce
confusion for the food industry and regulators.
    (Response 31) As the comments note, we provided additional clarity
regarding the foods on the FTL on January 11, 2021, in response to
stakeholder input following the publication of the proposed rule. The
FTL we are issuing with the publication of the final rule maintains
those clarifications and provides additional clarifications and
descriptions for the commodities on the FTL (Ref. 19). For some
commodities, we have added examples of foods that are and are not
considered part of that commodity designation on the FTL.
    (Comment 32) Multiple comments request that we provide exhaustive
lists of the foods for each commodity on the FTL and for commodities
not on the FTL.
    (Response 32) Considering the variety and range of food products
for each commodity, it would be very challenging to provide an
exhaustive list of foods for each commodity. As stated in Response 31,
we have provided additional clarifications and descriptions for the
commodities on the FTL, and for some commodities we have added examples
of foods that are and are not considered part of that commodity
designation on the FTL. We believe these clarifications and examples
will help stakeholders better understand the foods under each commodity
on the FTL.
    (Comment 33) One comment asks where they can find the commodity
risk scores mentioned in the proposed rule.
    (Response 33) The risk scores for the commodities on the FTL are
available in the RRM-FT Methodological Approach Report (Ref. 10).
    (Comment 34) A few comments support the use of the term ``Food
Traceability List'' to identify the list of foods that are covered by
the rule. The comments note that the term is preferable to use of the
term ``high-risk list,'' which could result in consumers avoiding
certain foods such as fruits and vegetables due to public perception of
the term ``high-risk.'' One comment argues that FDA must use the term
``high-risk list'' in the food traceability regulation to be consistent
with the language and intent of FSMA.
    (Response 34) While we acknowledge that section 204(d) of FSMA uses
the phrase ``high-risk foods,'' we believe the term ``Food Traceability
List'' is appropriate for the purposes of this rule. We agree with the
concerns raised about potential negative consumer perceptions of a
``high-risk list'' and resulting efforts to avoid foods on the list.
Furthermore, the FTL is based on specific concerns related to
traceability and is not meant to encompass all possible risk factors
associated with foods. To determine which foods should be included on
the FTL, we developed the RRM-FT based on the factors that Congress
identified in section 204(d)(2)(A) of FSMA. Those factors are specific
to what Congress required under FSMA and may not reflect other
approaches to assessing risk. Furthermore, in identifying foods for
inclusion on the FTL, we focused on hazards for which improved
traceability records would help protect the public health. For example,
as discussed below (see Response 86), we concluded that enhanced
traceability recordkeeping requirements would not greatly improve our
ability to identify and respond to undeclared allergens in food.
Therefore, although undeclared allergens pose a significant risk, we
did not incorporate this risk into our decision of which foods to
designate for the FTL. Consequently, to avoid unnecessary consumer
concerns and confusion with other risk determinations, we conclude that
it is appropriate to use the term ``Food Traceability List'' rather
than ``High-Risk Foods List.''
e. Foods vs. Commodities
    (Comment 35) Several comments claim that FSMA required FDA to
designate ``particular foods'' for the FTL rather than commodities. The
comments maintain that some foods within certain commodities, if scored
separately, would not have sufficient risk scores to be listed on the
FTL. One comment argues that grouping foods into commodities does not
accurately capture the risk of individual foods. Some comments assert
that the boundaries of the commodities on the FTL are not clearly
defined, which could result in confusion and ambiguity for some parts
of the industry. These comments maintain that submitting questions
through the FDA Technical Assistance Network (TAN) to inquire about
coverage of specific foods is complicated and not timely.
    (Response 35) We interpret the term ``particular food'' in section
204(d)(2)(A)(i), (ii), (v), and (vi) of FSMA in a way that is
reasonable and consistent with section 204(d), and that accurately
reflects the specificity of data available to us in developing the FTL.
As discussed in Response 7, data on individual foods, such as specific
varietals, is sparse and inconsistent across the variety of foods in
the Model and on the FTL. For the purposes of the FTL, we determined
that the appropriate level of granularity is at the level of
``commodity,'' e.g., ``tomatoes (fresh)'' rather than ``Roma tomatoes''
or ``cherry tomatoes.'' Food items within the same ``commodity''
designation generally have similar characteristics, associated hazards,
and production and supply chain practices and conditions. Further, data
used to assess components of the Model (e.g., outbreak and illness
data, likelihood of contamination, degree to which product supports
growth, consumption, annual cost of illness) are available and adequate
at the ``commodity'' level of granularity. See also Response 68 for a
discussion on the scope of the seafood commodity categories.
    As stated in Response 31, we have provided additional
clarifications and descriptions for the commodities on the FTL, and for
some commodities we have added examples of foods that are or are not
considered part of that commodity designation on the FTL. We believe
these clarifications and examples will help stakeholders better
understand the foods under each commodity on the FTL. As part of our
outreach to stakeholders regarding the final rule (see Section V.U.4 of
this document), we will continue to use the TAN to provide timely
responses to questions about the FTL and the subpart S requirements,
recognizing that some answers may take longer depending on the nature
of the question.
    (Comment 36) One comment argues that listing commodities would make
it more difficult to remove foods from the FTL because new food safety
technologies are typically applied to individual foods rather than
commodities as a group.
    (Response 36) As discussed in Section V.T.1 of this document, we
plan to periodically conduct a review to determine whether it is
appropriate to revise the FTL in accordance with the procedures set
forth in Sec.  1.1465 of the final rule. While there are several
factors that we must consider in determining which foods are on the
FTL, changes in industry practice, such as the use of new food safety
technologies, may result in a sufficient change in the risk score of a
commodity such that it would no longer be on the FTL.

    We encourage the development and adoption of new food safety
technologies to improve the safety of specific foods. If a company
develops a new food safety technology which they believe provides an
additional level of food safety for the food they produce, that company
might consider submitting a citizen petition requesting modified
requirements or an exemption from subpart S for certain products based
on use of that technology, using the procedure set forth in Sec.
1.1370 (see Section V.P of this document). We note that if new
technologies provide a ``kill step'' to FTL foods, the food might be
exempt from subpart S under Sec.  1.1305(d) of the final rule.
f. Add Foods to the FTL
    (Comment 37) Several comments suggest additions to the FTL. A few
comments suggest the FTL should be expanded to include all foods or all
foods that have caused foodborne illness. A few comments suggest
expanding the FTL to include all produce and all seafood. One comment
suggests expanding the FTL to include additional foods associated with
outbreaks, such as dried and frozen fruits, tahini, pistachios,
hazelnuts, and flour.
    (Response 37) We decline to make these changes to the FTL. Congress
explicitly directed us to establish additional recordkeeping
requirements for traceability for foods that meet certain risk-based
criteria. To determine which foods should be included on the FTL, we
developed the RRM-FT based on the factors that Congress identified in
section 204(d)(2)(A) of FSMA. The Model scores commodity-hazard pairs
according to data and information relevant to seven criteria described
in the RRM-FT Methodological Approach Report (Ref. 10). A commodity was
included on the FTL if its risk score, aggregated across all associated
hazards, was 330 or higher in the Model or if the evidence of outbreaks
and illnesses and cost of illness scores for one or more associated
commodity hazard pairs was ``strong'' (Ref. 15). If the foods suggested
by the comments are not on the FTL, it is because their risk scores
were not high enough to warrant inclusion on the FTL. As noted
elsewhere, we intend to revise the FTL on a regular basis based on
updates of the data in the Model. If the risk scores for foods
(including those specified in the comments) change, those foods could
be added to the FTL in a subsequent update to the list.
    We recognize that there are foods that have been linked to past
outbreaks but that are not on the FTL. Future outbreaks might also
occur among foods not on the FTL. No food is completely risk-free, and
we encourage all supply chain members to have systems and procedures in
place to enable them to rapidly and effectively engage in traceback and
traceforward activities for all of their foods, including those not on
the FTL. However, Congress made clear that the additional recordkeeping
requirements established by this rulemaking should only apply to foods
that FDA designated for inclusion on the FTL, and that these
requirements should have no effect on foods that are not so designated
(see section 204(d)(7) of FSMA).
g. The FTL and the High-Risk Designation
    (Comment 38) One comment requests that we not use the FTL for
purposes other than the traceability recordkeeping requirements, such
as establishing inspection frequencies or setting performance
standards. The comment asserts that ``high-risk'' is defined
differently depending on its context or use.
    (Response 38) We agree that ``high-risk'' is defined differently
depending on its context or use. Congress directed us to consider
specific factors in determining which foods should have additional
recordkeeping requirements for traceability. Those factors were
specific to section 204(d) of FSMA. Section 201 of FSMA, which is
codified as section 421 of the FD&C Act (21 U.S.C. 350j), directs FDA
to consider a different set of factors to identify high-risk facilities
for the purpose of determining the frequency of domestic inspections.
Performance standards can be used in a wide range of settings, and any
risk determination used for a performance standard would have to be
appropriate to that context.
h. Description of Foods on the FTL
    (Comment 39) One comment requests that we provide the scientific
name of plants and animals on the FTL. Another comment requests that we
use the naming conventions of the Codex Alimentarius or the Code of
Federal Regulations in identifying foods on the FTL.
    (Response 39) We decline these requests. The foods identified on
the FTL were based, in part, on data from FDA's RFR and facility
registration systems, which have existing naming conventions within FDA
systems. Further, FDA typically uses the common name of plants and
animals in its documents to help ensure that all stakeholders have an
understanding of the foods to which regulations or guidance apply.
Regarding requests to use other naming conventions, such as those in
the Codex Alimentarius or the Code of Federal Regulations, those naming
conventions were not developed for traceability, nor do they
necessarily conform to FDA's typical naming conventions.
i. Produce
    (Comment 40) Several comments ask for clarifications on the types
of melons that would be covered in the ``melon'' category and how
melons were deemed to be high-risk foods. The comments also request
that whole fresh watermelon be excluded from the FTL.
    (Response 40) In the melon category, the FTL includes all types of
fresh melons. Examples include, but are not limited to, cantaloupe,
honeydew, muskmelon, winter melon, bitter melon, and watermelon. As
previously stated, a commodity was included on the FTL if its risk
score, aggregated across all associated hazards, was 330 or higher in
the Model, or if the evidence of outbreaks and illnesses and cost of
illness scores for one or more associated commodity hazard pairs was
``strong.'' Based on the seven criteria used in the Model and the data
we have for melons, this commodity has a risk score that warrants its
inclusion on the FTL. Response 26 provides a description of the method
by which foods, including melons, on the FTL were determined, while
Response 6 discusses why the list uses commodity groupings (such as
melons) rather than individual foods (such as watermelons).
    (Comment 41) Several comments ask for clarification on how tropical
fruits were determined to be in the tropical tree fruit category and
whether certain fruits like bananas, avocado, and citrus are in that
category.
    (Response 41) The RRM-FT Methodological Approach Report (Ref. 10)
describes the classification of food commodities, including tropical
tree fruits. The tropical tree fruit designation allows for a grouping
of similar tree fruits, not other tropical fruit, that are typical to
locations that are hot and humid and whose longer day lengths allow for
fruit maturity. Examples of tropical tree fruits include (but are not
limited to) mango, papaya, mamey, guava, lychee, jackfruit, and
starfruit. Tropical tree fruits do not include non-tree fruits (such as
bananas, pineapple, dates, soursop, jujube, passionfruit, loquat,
pomegranate, sapodilla, and figs); tree nuts (such as coconut); pit
fruit (such as avocado); or citrus (such as orange, clementine,
tangerine, mandarins, lemon, lime, citron, grapefruit, kumquat, and
pomelo). However, derivatives or components of

some of the fruits that are not considered tropical tree fruits may be
on the FTL in other commodity categories, such as coconut butter in the
nut butter category, as discussed in this document.
    (Comment 42) Several comments ask whether the ``Tropical Tree
Fruits (fresh)'' category is limited to high-risk tree fruits and
includes other tropical tree fruit products that have undergone
processing but not a validated kill step, such as guava paste.
    (Response 42) The ``Tropical Tree Fruits (fresh)'' commodity is one
of two dozen commodities we identify in the commodity category
``Produce--RAC (raw agricultural commodity)'' based on the
consideration of the characteristics of the foods and production and
supply chain practices and conditions. The RRM-FT evaluates several
commodities for fresh fruits, including Tropical Tree Fruits (e.g.,
papaya), Tropical Fruits NEC. (e.g., banana), Citrus (e.g., orange),
Pome Fruits (e.g., apple), and Pit Fruits (e.g., avocado), and finds
that only the Tropical Tree Fruits commodity has a high enough risk
score to meet the threshold for inclusion on the FTL. Therefore, the
FTL includes fresh tropical tree fruits but does not include other
fresh tropical fruits. Fresh guava is covered under the ``Tropical Tree
Fruits (fresh)'' commodity. If fresh guava is used as an ingredient in
guava paste, the guava paste would also be included on the FLT.
However, if the guava paste is subjected to a kill step, the exemption
language in Sec.  1.1305(d) would apply.
    (Comment 43) Several comments request that we clarify the scope and
definition of leafy greens that are on the FTL. Some comments also
suggest that the FTL align with the Leafy Greens Marketing Association
(LGMA) definition of leafy greens.
    (Response 43) We have provided additional clarification to the
description of the commodity ``Leafy Greens (fresh)'' on the FTL,
specifying that it includes all types of fresh leafy greens (Ref. 19).
Examples include, but are not limited to, arugula, baby leaf, butter
lettuce, chard, chicory, endive, escarole, green leaf, iceberg lettuce,
kale, red leaf, pak choi, Romaine, sorrel, spinach, and watercress. The
``Leafy Greens (fresh)'' category does not include whole head cabbages
such as green cabbage, red cabbage, and savoy cabbage, nor does it
include banana leaf, grape leaf, and leaves that grow on trees. Also
note that fresh leafy greens listed as rarely consumed raw in Sec.
112.2(a)(1), such as collards, are exempt from the requirements of
subpart S under Sec.  1.1305(e) of the final rule.
    We believe the description of ``Leafy Greens (fresh)'' that is on
the FTL is generally aligned with the LGMA list of leafy greens.
However, we acknowledge that there are some differences. The LGMA list
includes whole head cabbages, which are not on the FTL, and spring mix,
which is not part of the ``Leafy Greens (fresh)'' category on the FTL
(but which is nonetheless on the FTL as part of the commodity ``Leafy
Greens (fresh-cut)''). The FTL description of ``Leafy Greens (fresh)''
includes some leafy greens that are not on the LGMA list, such as
chicory, watercress, pak choi, and sorrel.
    (Comment 44) A few comments request that collards be removed from
the proposed FTL as they are listed in the produce safety regulation
(in Sec.  112.2(a)(1)) as rarely consumed raw.
    (Response 44) Collards are exempt from the subpart S requirements
under Sec.  1.1305(e) of the final rule because they are currently
listed as rarely consumed raw in Sec.  112.2(a)(1). Otherwise, collards
would be subject to subpart S because they are part of the leafy greens
commodity category. To avoid confusion, we have removed collards from
the list of examples of leafy greens on the FTL.
    (Comment 45) One comment requests that we individually list, with
the applicable plant part(s), every fruit, vegetable, and culinary herb
that is subject to the rule, or expand the language in each category to
fully describe the intended subjects, including information such as the
species name(s), the plant part(s), the botanical characteristics
(e.g., whether the plant grows on the ground vs. a tree or a climbing
vine) and other information as appropriate to provide clear and
accurate descriptions.
    (Response 45) We do not agree that this level of detail is
necessary. Furthermore, adding botanical names could inadvertently
include or exclude commodities not intended to be on or off the FTL.
However, the revised FTL (Ref. 19) points out differences when
necessary, such as between beet root and beet greens, as well as dill
leaves and dill seed. The revised FTL also includes additional examples
of foods on the FTL.
    (Comment 46) Some comments ask that we confirm that ``frozen'' and
``fresh-frozen'' vegetables are not included on the FTL.
    (Response 46) Vegetables that are sold as ``frozen'' or ``fresh-
frozen'' are not included on the FTL because this product category was
analyzed separately from vegetables that are sold in other forms (e.g.,
fresh, dried), and frozen/fresh-frozen vegetables did not meet the
scoring criteria for inclusion on the FTL.
    (Comment 47) One comment agrees with FDA that whole apples, pears,
cherries, and fresh berries should not be on the FTL.
    (Response 47) Whole apples, pears, cherries, and fresh berries did
not have risk scores high enough to be included on the FTL and
therefore are not covered by the final rule.
    (Comment 48) Several comments request that we limit the FTL to
sprouts, fresh produce, and/or high-risk herbs like cilantro with risk
scores above the cutoff threshold of 330, and then phase in other foods
as part of subsequent FTL updates. The comments maintain that this
would allow FDA to ``test'' its traceability approach in the final
rule, especially since some sectors of the produce industry have
experience with traceability via participation in private traceability
initiatives.
    (Response 48) We decline to adopt the phased-in approach suggested
by the comments. Congress directed FDA to identify foods for which
additional recordkeeping requirements for traceability are necessary to
protect the public health. Limiting the foods on the FTL to a subset of
the commodities that had risk scores that merited inclusion on the list
would not be based in science and would reduce the public health
protections anticipated for the food traceability regulation.
    (Comment 49) A comment suggests that we clarify whether fresh-cut
produce that is ``rarely consumed raw'' under the produce safety
regulation falls under the subpart S requirements for fresh-cut
produce. One comment suggests that we provide more clarity about which
fresh-cut produce is included on the FTL, and additional clarity on the
methodology used to reach these conclusions.
    (Response 49) Produce that is ``rarely consumed raw'' according to
the produce safety regulation (Sec.  112.2(a)(1)) is exempt from the
subpart S regulations under Sec.  1.1305(e) for the entirety of the
supply chain, regardless of whether it is fresh-cut. For example,
although all fresh-cut fruits and vegetables are on the FTL, a fresh-
cut ``rarely consumed raw'' vegetable such as fresh diced butternut
squash would be exempt under Sec.  1.1305(e) because the fact that the
butternut squash is fresh-cut does not change its status as ``rarely
consumed raw.''
    (Comment 50) Some comments suggest that we reevaluate coverage of
mung bean sprouts under the FTL. These comments maintain that mung bean
sprouts should be considered rarely consumed raw and assert that few
food safety issues have been linked to mung bean sprouts and mung
beans.

The comments also ask us to reevaluate mung bean sprout consumption
data using more recent datasets.
    (Response 50) Fresh mung bean sprouts, as well as other types of
fresh sprouts, are covered by the produce safety regulation and are not
considered to be ``rarely consumed raw'' under Sec.  112.2(a)(1).
Section 112.2(a)(1) codifies an exhaustive list of all produce that is
considered ``rarely consumed raw,'' and revising that list is outside
the scope of this rulemaking. The commodity risk scores for fresh
sprouts, including mung bean sprouts, qualified this commodity for
inclusion on the FTL, as it has associated commodity-hazard pairs with
criteria scores in the moderate to strong range (Ref. 15, Table 1 and
Appendix I). We further note that, according to the FDA CORE Outbreak
Dataset (Ref. 11), between 1999-2019 there were eight documented
outbreaks related to consumption of mung bean sprouts, resulting in 319
illnesses and at least 2 deaths.
j. Herbs and Spices
    (Comment 51) One comment asks that we clarify that it is the fresh
version of herbs that are on the FTL and not the dried form (i.e.,
spices). The comment further maintains that tomatoes and peppers that
are dried or will be dried for spices or seasonings should not be
included on the FTL. The comment also asks for clarification on whether
capsicum annum pepper, if grown to become a spice, would be covered by
the rule. Another comment asserts that herbs that are destined to be
dried should not be covered by the rule because those herbs are grown,
processed, and consumed differently than fresh herbs. Another comment
recommends that spices, seasonings, and flavorings not be included on
the FTL. Another comment states that it understands that dried herbs
and spices are not covered by the rule because they are a separate
commodity in the Model and are not on the FTL.
    (Response 51) In the additional information on the FTL that we
provided on January 11, 2021, we noted that the form of herbs on the
FTL is the fresh form. Spices, seasonings, and flavorings are not
included on the FTL and therefore are not covered by the final rule. In
Response 30, we provide additional clarity regarding foods on the FTL
that are designated as ``fresh.'' Section 1.1305(d)(4) and (d)(5) of
the final rule (see Section V.E.5 of this document) provide further
clarification that if a food is changed such that it is no longer on
the FTL, then the food would not be covered. Therefore, dried herbs,
dried tomatoes, and dried peppers would not be covered by the final
rule because the FTL only includes the fresh versions of those foods.
    In addition, under Sec.  1.1305(d)(6), if an FTL food is destined
to be changed (e.g., through freezing, drying, or another change in
form of the food) such that it is no longer on the FTL, then that food
would not be covered from the point at which it is known that the FTL
food is destined to be changed, provided that the entities have a
written agreement as described in Response 196.
    Regarding the capsicum annum pepper, if the peppers are destined to
be dried for spices and the pepper shipper has a written agreement with
the receiver that the peppers will be dried, then, as noted above, the
shipper and receiver of the pepper would not be required to keep
subpart S records for the food. However, if the pepper shipper does not
have a written agreement, the shipper would need to maintain the
relevant subpart S records.
    (Comment 52) Comments request that we provide more clarity
regarding the specific part of the herb plant that is covered under the
FTL.
    (Response 52) For fresh herbs, any part of the herb that is fresh
and sold for human consumption would be covered under the FTL.
    (Comment 53) One comment asks that we limit the FTL to fresh
culinary herbs rather than all herbs.
    (Response 53) As discussed in Response 51, we have clarified that
the form of herbs on the FTL is the fresh form. We believe that further
clarification and distinction as ``culinary'' herbs is not necessary.
The ``Herbs (fresh)'' commodity is one of two dozen commodities we
identify in the commodity category ``Produce--RAC'' based on the
consideration of the characteristics of the foods and production and
supply chain practices and conditions. The Model scores the commodity-
hazard pairs at the commodity level (e.g., all fresh herbs) regardless
of the purpose of use because we are not aware of scientific evidence
that fresh produce within the same commodity does not share a
similarity in the characteristics of the food and in how they are
produced. Furthermore, we are not sure how the phrase ``culinary
herbs'' would be defined. In the Model, the ``Herbs (fresh)'' commodity
has criteria scores high enough to meet the threshold for inclusion on
the FTL.
k. Deli Salads
    (Comment 54) Several comments assert that ``deli salad'' is a vague
term that has different meanings in some sectors of the food industry,
and other comments request that we clarify how we interpret the deli
salad category for the RRM-FT. Some comments ask that we specify
whether an ``antipasti'' salad would be considered a deli salad.
    (Response 54) The ready-to-eat (RTE) deli salads commodity in the
RRM-FT includes prepared refrigerated and RTE deli salads (e.g., potato
salad, egg salad, pasta salad, seafood salad). While the term ``deli
salad'' appears to be a broad term, it is intended to capture multiple
types of RTE deli salads, including the aforementioned examples as well
as a prepared antipasti salad. However, a prepared, RTE antipasti salad
could include meat as an ingredient, which may place it under the
jurisdiction of USDA and therefore make it exempt from the requirements
of subpart S under Sec.  1.1305(g).
    (Comment 55) Several comments request exemption of deli salads from
the subpart S requirements. Some comments assert that RTE deli salads
like pasta and potato salad that are processed and prepared using
hurdle technology or other controls to minimize pathogen growth should
not be included on the FTL. Similarly, other comments assert that these
types of RTE salads that are processed and prepared using controls such
as pH and preservatives (e.g., antimicrobials and Listeria inhibitors)
do not pose the same risk as RTE salads that do not use the hurdle
approach.
    (Response 55) While we acknowledge that the use of preservatives
and antimicrobials in deli salads helps to minimize bacterial growth,
the data provided in the comments do not change how we score deli
salads in the RRM-FT. The hurdle approach, as opposed to a kill step,
can vary widely in terms of procedure and is not consistently applied
throughout industry.
    Therefore, based on the available data, we conclude it is not
appropriate to grant a blanket exemption for deli salads processed
using hurdle technology or related procedures.
l. Nut Butters
    (Comment 56) Some comments ask us to include all butters (nut, soy,
and seed) on the FTL that are considered allergenic. Other comments
question why soy and seed butters in general were not included on the
FTL. These comments assert that soy and seed butters have similar
manufacturing processes and supply chain standards, and thus pose the
same risk as nut butters. Additionally, some comments assert that
consumption patterns might be shifting from peanut butter to seed
butter due to allergies.

    (Response 56) We decline to include all butters considered
allergenic or all soy and seed butters on the FTL. As previously
stated, we developed a risk-ranking model for food tracing based on the
factors in section 204(d)(2)(A) of FSMA. A commodity was included on
the FTL if its risk score, aggregated across all associated hazards,
was 330 or higher in the Model, or if the evidence of outbreaks and
illnesses and cost of illness scores for one or more associated
commodity hazard pairs was ``strong.'' Using the RRM-FT, we evaluated
nut butters (e.g., made from tree nuts and peanuts) and soy and seed
butters (e.g., made from edible seeds) as separate commodities and
found that only the nut butters had a risk score high enough to meet
the threshold for inclusion on the FTL. Therefore, only nut butters are
covered by the rule. As previously stated, we will periodically review
data and information relevant to the RRM-FT criteria for commodity-
hazard pairs, including the consideration of consumption patterns and
food safety improvements across commodities.
    The inclusion of nut butters on the FTL does not relate to the fact
that nut butters can be allergenic. See Response 86 for a discussion of
how we assessed the risks that are related to allergens.
    (Comment 57) Several comments request clarification on whether nut
butters made with raw nuts pose the same level of risk as nuts that are
roasted, even when applying a process control during the roasting
process that results in a 4- to 5-log reduction of the pertinent
pathogen.
    (Response 57) We acknowledge that adequate process controls
resulting in a 4- to 5-log reduction in the pertinent pathogen should
minimize the risk associated with nuts. However, it is the nut butter,
not the nuts, that is on the FTL and covered by the final rule. The nut
butters commodity, regardless of whether the ingredient nuts were raw
or roasted, ranked high in the RRM-FT, which is why nut butters are
included on the FTL. While applying a validated roasting process
control for peanuts may mitigate the associated hazard, we continue to
see multiple outbreaks associated with recontamination of peanuts and
peanut butter after the roasting step. We also know from previous FDA
investigations that there are sources of environmental pathogens (e.g.,
Salmonella spp., L. monocytogenes) in facilities, and routes of
contamination for these pathogens into the nut butters have been
associated with employee practices, insanitary conditions, and
inadequate sanitation practices. Using roasted nuts that have undergone
a properly designed and implemented process control should mitigate the
hazard associated with this ingredient; however, it does not reduce the
risk of the potentially significant hazards posed by the exposed nut
butters in the post-processing environment.
    (Comment 58) Several comments ask whether nut meals and powders,
nut flours, nut flavoring extracts, and similar commodities are on the
FTL. Some comments request that we clarify whether peanut butter chips
fall under the nut butter category on the FTL. Some comments assert
that peanut butter chips should not be considered nut butters but
should be a separate commodity that is exempt from the rule.
    (Response 58) ``Nut meals and powders,'' ``Flours (wheat, rice or
soy),'' and ``Flavorings'' are all separate commodity designations from
the ``nut butters'' designation. These commodities were assessed
separately in the RRM-FT and did not have risk scores that would
include them on the FTL.
    Peanut butter chips are not in the ``nut butters'' commodity.
However, if peanut butter chips are produced using peanut butter as an
ingredient, they are covered by the rule because they contain an
ingredient on the FTL (peanut butter). However, if a kill step is
applied to the peanut butter chips, the exemption in Sec.  1.1305(d)
would apply.
    (Comment 59) Some comments request that we clarify whether
``coconut butter'' and ``Chinese chestnut butter'' are covered by the
rule under the nut butter category. The comments maintain that
``coconut'' qualifies as a ``tree nut'' for purposes of the Food
Allergen Labeling and Consumer Protection Act of 2004, but that in many
countries it is not considered a ``tree nut'' because it does not meet
common definitions of ``nut,'' nor does it grow on ``trees.'' The
comments suggest that if we intend ``nut butter'' to include coconut
butter, we should say so explicitly in the FTL and have data
appropriate to deem coconut nut butter a ``high-risk food.''
    (Response 59) As discussed in Response 39, we use data from FDA's
RFR and facility registration systems to help determine commodity
designations for the FTL. Based on those classification systems, we
consider coconut to be a nut; therefore, coconut butter is included on
the FTL as a nut butter. This is consistent with 21 CFR 170.3, which
also classifies coconut as a nut. We consider Chinese chestnut to be a
tree nut and, therefore, Chinese chestnut butter also is an FTL food
subject to the subpart S requirements. We have added both coconut
butter and chestnut butter to the FTL as examples of ``nut butters'' to
clarify that they are included in this category. See the RRM-FT results
tool (Ref. 17) for information about risks associated with nut butters.
    (Comment 60) One comment expresses support for the fact that
almonds/tree nuts are not on the FTL. The comment further asserts that
domestically sold almonds are required to apply a kill step, which the
comment argues is relevant when considering risk of a created product
that is on the FTL, such as nut butter.
    (Response 60) Nuts are not on the FTL; however, nut butters are on
the FTL and subject to the rule, regardless of how the raw ingredients
are processed. For example, almond butter is on the FTL and is covered
by the rule regardless of whether the almonds received a kill step
before being processed into almond butter. The RRM-FT considers
potential hazards that may be introduced from exposure to the
processing environment after a lethality treatment (Refs. 20 and 21),
e.g., contamination of Salmonella spp. in a nut butter after roasting
(which is a kill step for the nut, but not a kill step for the nut
butter). Based on available data for the seven criteria in the RRM-FT,
the risk score for the commodity ``nut butters'' meets the criteria for
inclusion on the FTL.
    (Comment 61) Several comments outline initiatives the peanut butter
industry has undertaken to significantly reduce the risk of outbreaks
and illness from peanut butter and peanut butter products. Some
comments maintain that nut butter scored low on contamination under the
RRM-FT, but peanut butter scored high for frequency of consumption,
number of outbreaks, and severity of illness. Other comments assert
that nut butter was included on the FTL primarily due to the high-
profile recalls that occurred before the adoption of the preventive
controls for human food regulation. The comments argue that because of
the efforts by industry and the fact that major peanut butter outbreaks
occurred several years in the past, peanut butter should not be
included on the FTL.
    (Response 61) We appreciate the industry interventions to reduce
the risk of outbreaks and illnesses caused by peanut butter and peanut
butter products. However, we disagree that these efforts justify
removal of peanut butter from the FTL at this time. As previously
stated, a commodity was included on the FTL if its risk score,
aggregated across all associated hazards, was 330 or higher in the
Model, or if the evidence of outbreaks and illnesses and cost of
illness scores for one or more

associated commodity hazard pairs was ``strong.'' Based on the seven
criteria used in the Model and the data we have for peanut and tree nut
butters, these products have risk scores that warrant their inclusion
on the FTL. We further disagree with the comments asserting that the
high-profile nut butter recalls that occurred before the adoption of
the preventive controls for human food regulation were the primary
reason nut butters made the FTL. As with all commodities, the RRM-FT
scores for nut butters are specific to data and information on these
foods relevant to the seven criteria used in the Model. The most recent
information concerning industry intervention efforts considered in the
RRM-FT was from 2019. Further, the RRM-FT down-weights older data. As
stated in Response 488, we will periodically review data and
information relevant to the RRM-FT seven criteria for commodity-hazard
pairs, including the consideration of food safety improvements across
commodities, to determine whether revisions to the FTL may be
appropriate.
m. Cheese
    (Comment 62) One comment asks for an explanation of why the RRM-FT
ranks some cheese commodities from pasteurized milk higher than some
cheese commodities from unpasteurized milk.
    (Response 62) The RRM-FT scores commodity-hazard pairs according to
data and information relevant to seven criteria described in the
Methods report (Ref. 10). The semi-quantitative RRM-FT model does not
directly quantify the probability of illnesses (e.g., the risk of
illnesses per year or per serving for a consumer) but rather provides a
ranking of commodities based on risk scores. The model results ranked
the ``Cheese (made from pasteurized milk), soft ripened or semi-soft''
commodity and the ``Cheese (made from pasteurized milk), fresh soft or
soft unripened'' commodity higher than the ``Cheese (made from
unpasteurized milk), other than hard cheese'' commodity.
    A 2015 FDA/Health Canada quantitative risk assessment (Ref. 22) of
soft-ripened cheese showed that on a per serving basis, the risk to
consumers was higher for raw (unpasteurized) milk soft-ripened cheese
than for pasteurized milk soft-ripened cheese. The RRM-FT results do
not conflict with the quantitative risk assessment results. However,
the RRM-FT is more aligned with a risk estimate on a population basis.
For example, it includes a criterion that captures the percentage of
the population that consumes the food in addition to the amount
consumed per serving. When contaminated foods are consumed by a large
percentage of the population, they are more likely to cause outbreaks
or multiple illnesses compared to contaminated foods consumed by only a
limited percentage of the population, given similar prevalence and
levels of contamination and serving size. While all seven criteria
contribute to the overall risk score of each of these commodities, the
consumption criterion (Criterion 6) is the key to understanding the
relative ranking of cheese made from unpasteurized milk to cheese made
from pasteurized milk. In the RRM-FT, data indicated that cheeses made
with unpasteurized milk are consumed by a much smaller percentage of
the population than counterpart cheeses made with pasteurized milk,
while the amount consumed per serving was approximately the same. If
the percentage of the population consuming unpasteurized milk cheese
was more comparable to that of the other cheeses, the risk score for
the ``Cheese (made from unpasteurized milk), other than hard cheese''
commodity would have been at least as high as the risk score for the
highest scoring pasteurized milk cheese commodity on the FTL. The RRM-
FT results tool (Ref. 17) provides more information on the risk scores
for relevant commodity-hazard pairs.
    (Comment 63) One comment suggests that the cheeses on the FTL
should be limited to Hispanic soft cheese made from raw milk, queso
fresco, Latin-style soft cheeses, and soft cheeses. Another comment
suggests that cheeses on the FTL be limited to soft uncured cheeses
with no kill step, asserting that those are the only cheeses that have
triggered a specific FDA warning and related consumer food safety
education.
    (Response 63) We decline to limit the cheeses on the FTL to
Hispanic soft cheese made from raw milk, queso fresco, Latin-style soft
cheeses, and soft cheeses, in particular soft uncured cheeses. Cheeses
other than these had commodity risk scores under the RRM-FT that
warranted their inclusion on the FTL. The commodity risk score for
cheese (made from pasteurized milk) soft ripened or semi-soft was 490;
the commodity risk score for cheese (made from pasteurized milk) fresh
soft or soft unripened was 430; and the commodity risk score for cheese
(made from unpasteurized milk) other than hard cheese was 410. Because
each of these cheese commodities had a commodity risk score above 330,
they are all included on the FTL.
    (Comment 64) Several comments request that various cheeses be
removed from the FTL, including cream cheese, processed mozzarella
cheese, cheese made from pasteurized milk, processed cheese, process
cheese products, and LACF cheese. One comment notes that cottage cheese
is typically produced in Grade ``A'' milk plants regulated under the
Pasteurized Milk Ordinance (PMO) and argues that the production process
in those plants results in a product that does not support the survival
and/or growth of bacteria. Another comment asks whether pasteurization
of the milk that is used to make cheese is considered a kill step.
    (Response 64) Cottage cheese is covered by the final rule because
it is included on the FTL in the commodity ``Cheese (made from
pasteurized milk), fresh soft or soft unripened.'' However, we
recognize that much of the cottage cheese produced in the United States
is regulated under the PMO, a Federal program that includes specific
requirements for processing and frequent testing and inspection by
regulatory authorities. Therefore, we are considering initiating a
process under Sec.  1.1360 to determine whether to exempt cottage
cheese regulated under the PMO from the subpart S requirements.
    As discussed in Section V.E.5 of this document, if a person applies
a kill step, such as pasteurization, to a cheese on the FTL, the person
is eligible for a partial exemption from subpart S under Sec.
1.1305(d)(3). Therefore, pasteurized process and pasteurized prepared
cheese and cheese products (e.g., pasteurized process cheese,
pasteurized process cheese food, pasteurized cheese spread, pasteurized
blended cheese, pasteurized prepared cheese product), as well as
processed mozzarella cheese, would be eligible for the partial
exemption in Sec.  1.1305(d)(3). LACF cheeses are a separate category
in the RRM-FT and are not on the FTL.
    Regarding cheese made with pasteurized milk, as discussed in
Response 62, the commodity risk scores for both ``Cheese (made from
pasteurized milk), soft ripened or semi-soft'' and ``Cheese (made from
pasteurized milk), fresh soft or soft unripened'' were both high enough
to merit inclusion on the FTL. Similar to the previous discussion in
Response 60 regarding peanut butter made from roasted peanuts, these
two categories of cheeses made from pasteurized milk are on the list
regardless of the fact that one of their ingredients was previously
subjected to a kill step.
    (Comment 65) Many comments request clarity and definitions for the
cheese categories, as well as information on which specific cheeses
within the categories are on the FTL. The

comments ask that the categories be based on a science- and risk-based
assessment. Some comments question whether the cheese categories are
based on relevant standards of identity (SOI) or moisture level in the
cheeses, further noting that there is no SOI that defines the term
``soft cheese'' or academic consensus on the definition of ``soft
cheese.'' The comments maintain that the category ``Cheeses, other than
hard cheeses'' could include many low-risk and semi-soft cheeses (e.g.,
Asiago and Manchego), and they ask whether the category also includes
non-hard cheeses packed in wax (e.g., fontina in wax). In addition,
some comments express concern that FDA inspectors may apply terms like
``soft cheese'' inconsistently and over-inclusively due to a lack of
clarity and definitions for the cheese categories.
    (Response 65) The commodity ``Cheese'' is broken down into three
categories on the FTL:
     Cheese (made from pasteurized milk), fresh soft or soft
unripened. Examples include, but are not limited to, cottage, chevre,
cream cheese, mascarpone, ricotta, queso blanco, queso fresco, queso de
crema, and queso de puna;
     Cheese (made from pasteurized milk), soft ripened or semi-
soft. Examples include, but are not limited to, brie, camembert, feta,
mozzarella, taleggio, blue, brick, fontina, Monterey jack, and
muenster; and
     Cheese (made from unpasteurized milk), other than hard
cheese, which includes all cheeses made with unpasteurized milk, other
than hard cheeses.
    These three categories encompass all cheeses except hard cheeses.
Although we cannot provide an exhaustive list of cheeses on the FTL, we
have revised the FTL to provide additional clarification of the cheese
categories, better align with the RRM-FT, and provide examples of
cheeses in each category. The FTL now states the commodity is
``Cheeses, other than hard cheeses'' and specifies that ``hard
cheeses'' include hard cheeses as defined in Sec.  133.150 (21 CFR
133.150), Colby cheese as defined in 21 CFR 133.118, and caciocavallo
siciliano cheese as defined in 21 CFR 133.111. Examples of hard cheese
include, but are not limited to, cheddar, Romano, and parmesan. Even
though there is not a clear definition of ``fresh soft'' or ``soft
unripened'' cheese (note that ``soft ripened'' cheese is defined in 21
CFR 133.182), the fact that the only category of cheese that is not on
the FTL is hard cheese should eliminate concerns of inconsistency in
applying the final rule. Packaging and wrapping do not affect whether
or not a cheese is on the FTL.
    We have further clarified that the cheese commodities that are on
the FTL do not include cheeses that are frozen, shelf stable at ambient
temperature, or aseptically processed and packaged. This is a result of
how foods are categorized within the Model (see Response 26 for a
description of the method by which foods on the FTL were determined).
Therefore, if a cheese that is on the FTL in its unfrozen form becomes
frozen--for example, as part of a frozen pizza--that would be
considered a change such that the food is no longer on the FTL and
therefore no longer covered by the final rule (see Response 27).
Cheeses that are shelf stable at ambient temperature or aseptically
processed and packaged are also not on the FTL and are therefore not
covered by the final rule.
    (Comment 66) One comment asks how firms can ensure that the
preceding entity in the supply chain has properly classified the cheese
so that it does not create an undue burden or put the receiving firm's
own compliance at risk.
    (Response 66) We expect persons who manufacture, process, pack, or
hold any FTL food covered by the final rule to be in compliance with
the regulations. Persons subject to the rule are responsible for
knowing whether they must keep subpart S records, independent of any
assessment or classifications made by persons preceding them in the
supply chain. We expect firms to work with their suppliers to be
familiar with the products they are providing, and we note that other
regulations, such as those on preventive controls for human food and
foreign supplier verification programs (FSVP), require covered entities
to work with their suppliers to help ensure compliance with those
regulations.
n. Seafood
    (Comment 67) Comments specific to seafood assert that the scope of
the FTL exceeds the definition of ``high-risk'' stated in section 204
of FSMA. The comments ask that we modify the RRM-FT risk criteria by
limiting it to outbreak and recall data, and be more specific in
identifying high-risk commodities (e.g., scombrotoxin-forming species,
RTE seafood) rather than using broad categories (e.g., finfish).
    (Response 67) As discussed in Response 4, section 204(d)(2)(A) of
FSMA sets forth the factors that FDA is required to consider in
designating foods for inclusion on the FTL. Because the factors are
established in the statute, we cannot limit the risk criteria in the
RRM-FT to outbreak and recall data.
    As discussed in Response 35, we determined that the appropriate
level of granularity for designating foods on the list is at the level
of ``commodity'' (e.g., ``Finfish (histamine-producing species'')). In
the FTL published with the final rule, we have provided additional
clarifications and descriptions for the commodities on the FTL, for
example by separately identifying the finfish commodities and providing
additional examples for each commodity designation.
    (Comment 68) Some comments suggest that the RRM-FT fails to
recognize the variability of hazards associated with individual seafood
species and products in identifying foods for inclusion on the list,
and instead focuses on overly broad commodity groups with limited
commonalities. Some comments object to the assumption that ``items
within the same `commodity' designation generally have similar
characteristics, associated hazards, and production and supply-chain
practices and conditions.''
    (Response 68) We disagree with the comments. The RRM-FT considers
the nature of the food through a categorization scheme that classifies
FDA-regulated foods into 47 commodity categories. The 47 commodity
categories represent categories of foods available to consumers from
various supply chains and different production, manufacturing, and
handling processes and practices. Furthermore, within each commodity
category, the RRM-FT identifies more than 200 individual commodities,
again taking into consideration the nature of foods as well as the
characteristics of their production and manufacturing processes. For
example, the commodity category ``Seafood-Finfish'' includes four
commodities that are on the FTL because they have a risk score that
meets the threshold for inclusion on the FTL: ``Finfish--finfish--
histamine-producing species,'' ``Finfish--finfish--species not
associated with histamine or ciguatoxin,'' ``Smoked finfish,'' and
``Finfish--finfish--species potentially contaminated with ciguatoxin.''
The identification of individual commodities allows for consideration
of the differences in the nature of the food, the range of hazards, and
the production and manufacturing processes. Therefore, we have
considered variability of hazards through the identification of
species-specific hazards and hazards associated with processing. The
identification of commodity-hazard pairs is based on available data and
information, e.g., foods and hazards

associated with outbreaks and illnesses and detection of hazards in
foods. We use information from RFR reports, published literature,
scientific studies, technical reports from governmental and other
organizations, FDA surveillance and testing data, a review of world-
wide published risk assessments, and expert knowledge. As discussed in
Response 35, in reviewing the data and developing the FTL, we
determined that the appropriate level of granularity is at the level of
``commodity.'' The peer reviewers for the Model (Ref. 13) made a
variety of suggestions on the food classification, particularly
modifications at the commodity level, so that it would be appropriate
and supportable by available data. The peer reviewers supported
grouping foods with similar ecology and manufacturing conditions (even
if not yet involved in documented outbreaks). Further, data used to
assess components of the Model (e.g., outbreak and illness data,
likelihood of contamination, degree to which product supports growth,
consumption, and annual cost of illness) are available and adequate at
the ``commodity'' level of granularity.
    (Comment 69) Many comments address the seafood species and products
included on the FTL and compare these seafood products to FDA's seafood
safety guidance, ``Fish and Fishery Products Hazards and Controls''
(Ref. 23), which is used by regulators and industry in identifying
likely food safety hazards associated with fish and fishery products.
The comments assert that the FTL is inconsistent with FDA's existing
guidance and ask that the final rule provide a rationale for this
purported inconsistency.
    (Response 69) The purpose of the Fish and Fishery Products Hazards
and Controls guidance is to help firms identify hazards reasonably
likely to occur and develop a seafood hazard analysis critical control
point (HACCP) plan to control these hazards. The guidance is a science-
based tool firms use to help develop preventive controls for the
seafood they handle. The purpose of the FTL, however, is to improve
traceability in the event of a foodborne illness outbreak involving
foods on the list. As discussed in Response 5, the FTL is a list of
food commodities informed by a risk-ranking model that ranks food-
hazard pairs based on seven criteria.
    (Comment 70) Some comments assert that very few seafood species and
products were associated with food safety hazards that originate from
the growing environment. The comments suggest that FDA exclude products
that have only been associated with recalls related to hazards
introduced during processing from the burden of tracing back to the
harvest waters.
    (Response 70) We disagree with these comments. Seafood food safety
hazards can be introduced throughout the supply chain. Natural marine
toxins and pathogens are examples of the hazards that are in the
growing environment and can contaminate seafood. In the RRM-FT, we
identify and evaluate both species-related (from the growing
environment) and process-related hazards that are known or reasonably
foreseeable for more than a dozen seafood commodities (Ref. 17), which
is consistent with the intent of this regulation to enhance FDA's
ability to trace foods on the FTL throughout the supply chains of those
foods.
    (Comment 71) Several comments contend that very few illnesses can
be attributed to the consumption of shrimp in general and that domestic
wild-caught shrimp have a drastically lower rate of consumption in the
United States when compared to aquacultured shrimp. The comments
further maintain that the open ocean environment in which domestic
wild-caught shrimp are harvested is unlikely to present any safety
hazards, and they recommend removing domestic wild-caught shrimp from
the FTL. Conversely, the comments assert that aquacultured shrimp,
whose growing conditions have been associated with introduction of food
safety hazards, is more likely to present a potential health hazard.
The comments do not request that we exclude foreign wild-caught shrimp
from the FTL.
    (Response 71) The RRM-FT did not differentiate between wild-caught
and aquacultured shrimp. We acknowledge that hazards introduced from
the growing waters for wild-caught shrimp and aquacultured shrimp may
differ. However, there are commonalities in hazards being introduced
after harvest, such as the addition of sodium metabisulfites to prevent
melanosis and pathogen hazards introduced during handling and
processing after capture, as well as commonalities in the potential for
shrimp (regardless of wild-caught or aquaculture) to support pathogen
growth. The RRM-FT considers the totality of the food chain in the
interest of public safety. As previously discussed, we balanced a
number of factors in determining the granularity of commodity
definitions, including the characteristics of the food and availability
of data used to evaluate the seven criteria for commodity-hazard pairs.
Shrimp (both wild-caught and aquaculture) is evaluated in the commodity
``Crustaceans'' (see Response 35 for further discussion of why we
evaluate risks at the ``commodity'' level).
    (Comment 72) Several comments assert that the requirements of the
proposed rule are duplicative and not beneficial in the case of canned
tuna. The comments maintain that: existing harvest certification
requirements provide traceability to the vessel; LACF product coding
requirements and National Oceanic and Atmospheric Administration (NOAA)
product traceability requirements provide traceability throughout the
food chain; FDA's safety requirements and recommendations in other
regulations and guidance documents address food safety hazards; and
canned tuna has a history of being safe based on global recall data.
    (Response 72) Because the commodity ``Canned Seafood'' in the RRM-
FT, which includes canned tuna, did not score high enough to be on the
FTL, canned tuna is not on the FTL and therefore is not covered by the
final rule.
    (Comment 73) Some comments request that the allowance for a ``kill
step'' exemption not exclude smoked fish from the FTL given the history
of contamination in the finished product due to cross-contamination
after smoking.
    (Response 73) We agree that smoked finfish should be included on
the FTL. The ``smoked finfish'' commodity in the RRM-FT includes both
hot and cold smoked finfish. Based on available data for the seven
criteria in the RRM-FT, the risk score for ``smoked finfish'' is high
enough to merit inclusion on the FTL. Therefore, both hot and cold
smoked finfish are included on the FTL. We note that the hot smoking
step typically is not applied to the finished product, so it does not
address potential environmental contamination introduced after smoking
when the finfish is sliced and otherwise handled before packaging. The
RRM-FT demonstrated that food safety hazards can be introduced from
exposure to the processing environment after the lethality treatment
(e.g., contamination of L. monocytogenes in smoked finfish after
smoking).
    (Comment 74) Many comments object to the inclusion on the FTL of
the category ``Finfish, species not associated with histamine or
ciguatoxin.'' The comments argue that those species have no associated
species-related safety hazards or have only species-related hazards
that are controlled because the

products are normally consumed cooked.
    (Response 74) Finfish species not associated with histamine or
ciguatoxin are on the FTL in part because they are highly consumed and
may be contaminated with microbial hazards that can cause severe
illnesses (e.g., L. monocytogenes, Vibrio parahaemolyticus, Salmonella
spp.). While there are relatively few documented outbreaks for this
finfish commodity, it is often difficult to identify the source
associated with L. monocytogenes outbreaks due to factors such as long
incubation time and sporadic illnesses, which complicates outbreak
investigations. Further, data for this commodity in the RRM-FT indicate
the likelihood of contamination is above 1 percent (i.e., Criterion 3
score of 9), and consumption and severity of illness both score high.
Given these high scores, the risk score for the finfish commodity is
above the line for inclusion on the FTL.
    (Comment 75) Some comments assert that frozen seafood products
present less of a risk than refrigerated products because maintaining
seafood in frozen form inhibits pathogen growth and potentially
eliminates parasites. The comments request that we consider the safety
effects of freezing as part of risk profiles when identifying high-risk
products.
    (Response 75) We agree that freezing can inhibit the growth of pre-
existing pathogens and additional development of scombrotoxin and
potentially can eliminate parasites. However, freezing does not remove
the presence of pathogens in the way that a kill step does; it does not
eliminate scombrotoxin that may have formed before freezing and it does
not eliminate the presence of ciguatoxin. In addition, thawing of the
product within the commercial seafood chain re-introduces the potential
for pathogen growth and scombrotoxin formation. It is not uncommon for
seafood products to be thawed and then refrozen as they move through
the supply chain, and because the description of a commodity within the
RRM-FT refers to the state in which the product appears at retail, such
seafood is classified as ``frozen'' despite having previously been
thawed. This is one reason why, for many seafood commodities, we have
classified fresh and frozen products together within the Model, rather
than separating them into different commodities. Because the Model
identified many such seafood commodities as scoring high enough to be
included on the FTL, the enhanced traceability recordkeeping
requirements of subpart S apply to these types of seafood regardless of
whether they are sold fresh or frozen. The updated version of the FTL
we are publishing with this final rule specifies when the frozen form
of a product is included on the list.
    (Comment 76) Several comments support expanding the FTL to include
all seafood products, most notably Siluriformes such as catfish, which
are regulated by USDA, and scallop adductor muscles, which the RRM-FT
identifies as ``low risk.''
    (Response 76) All fish of the order Siluriformes, including
catfish, are considered ``amenable species'' under the Federal Meat
Inspection Act (see 21 U.S.C. 601(w)(2)) and are subject to exclusive
USDA jurisdiction at certain points in the food production chain. FDA
does not have the authority to impose recordkeeping requirements on
facilities that are under exclusive USDA jurisdiction. Consequently, as
discussed in Section V.E.8 of this document, the final rule (in Sec.
1.1305(g)) provides an exemption for such food during the time it is
within the exclusive jurisdiction of the USDA under the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection
Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21
U.S.C. 1031 et seq.). In addition, we are choosing not to cover food
after it is within the exclusive jurisdiction of USDA because the most
successful traceability efforts will have an unbroken chain of records.
Similarly, we chose not to include Siluriformes such as catfish in the
risk-ranking model that we used to identify foods for inclusion on the
FTL. Because Siluriformes are subject to exclusive USDA jurisdiction at
certain points in the food production chain, we are unable to ensure an
unbroken chain of traceability records. Therefore, we are not expanding
the FTL to include Siluriformes such as catfish as requested.
    We also decline to expand the FTL to include scallop adductor
muscle. As discussed in Section V.E.7 of this document, the final rule
(in Sec.  1.1305(f)) exempts from the subpart S requirements raw
bivalve molluscan shellfish, including scallops, that are: covered by
the requirements of the National Shellfish Sanitation Program (NSSP);
subject to the requirements of part 123, subpart C (21 CFR part 123,
subpart C), and Sec.  1240.60 (21 CFR 1240.60); or covered by a final
equivalence determination by FDA for raw bivalve molluscan shellfish.
The final product form of the adductor muscle only is not covered by
the NSSP requirements or subject to the requirements of part 123,
subpart C, and Sec.  1240.60 (Ref. 23). We have adopted this same
approach and rationale in the final rule.
    (Comment 77) Several comments recommend expanding the FTL to
include all seafood products as a means of preventing economic fraud,
including species substitution, by ensuring product traceability
throughout the supply chain. One comment suggests that feed for
aquaculture be covered under the rule to help ensure that products that
may have been created through forced labor or illegal fishing do not
enter the U.S. market.
    (Response 77) FSMA section 204(d) defines the scope of this rule
and limits its coverage to only those foods that FDA designates for
inclusion on the FTL, based on the factors Congress provided in section
204(d)(2)(A). The purpose of the rule is to enhance traceability to be
able to rapidly and effectively identify recipients of a food on the
FTL to prevent or mitigate a foodborne illness outbreak and to address
credible threats of serious adverse health consequences or death. We
cannot expand the scope of the rule to address other concerns, such as
forced labor or illegal fishing. However, under FDA's New Era of
Smarter Food Safety initiative, we will continue to explore ways to
encourage all entities in the supply chain to adopt tracing
technologies and harmonize tracing activities to support end-to-end
traceability throughout the food safety system. Additional information
on this initiative can be found in FDA's Blueprint for New Era of
Smarter Food Safety (Ref. 18).
o. Dietary Supplements
    (Comment 78) One comment supports the fact that dietary supplements
are not on the FTL and therefore not covered by the rule, as the
comment maintains that dietary supplements are rarely implicated in
foodborne illness outbreaks. One comment suggests that because dried
spices and dried vegetables are not covered by the rule, dietary
supplements that include dried herbs and vegetables also should not be
covered by the rule. The comment further suggests that dietary
supplements that include fish or krill oil also should not be covered.
One comment asserts that herbs used in dietary supplements should not
be covered by the rule because dietary supplements are not covered.
Another comment maintains that including fresh herbs used in dietary
supplements under the commodity ``Herbs (fresh)'' is not supported by
evidence because, according to the comment, FDA uses RFR data to
identify hazards for fresh

herbs, but dietary supplements are not included in RFR reporting.
    (Response 78) The RRM-FT includes data regarding dietary
supplements, and dietary supplements are a separate commodity in the
Model. The commodity ``Dietary supplements'' did not score high enough
to merit inclusion on the FTL. Many ingredients that are often found in
dietary supplements, such as dried herbs, dried vegetables, fish oil,
and krill oil, are also not on the FTL. Dietary supplements containing
these ingredients are therefore not covered by the rule. However, if a
dietary supplement uses fresh herbs, such as in some refrigerated
dietary supplements, those supplements would be covered by the rule
because, as discussed in Response 27, the rule covers multi-ingredient
products that contain specifically listed FTL foods as ingredients, as
long as the form of the ingredient is the same as the form that appears
on the FTL (e.g., ``fresh'').
p. Animal Food
    In the preamble to the proposed rule, we stated that although
section 204(d) of FSMA does not exclude food for animals, we did not
include animal foods in the RRM-FT. We stated that the RRM-FT was
designed to account only for humans and cannot accommodate
applicability to other animal species. However, we stated that we might
revisit the issue of animal foods when we conduct any future
reassessments of the Model (see 85 FR 59984 at 59991).
    (Comment 79) Some comments agree that animal food should not be
covered under the same risk-ranking model as human food. These comments
generally agree that a primary reason the RRM-FT should not be used for
animal food is because animal illness data associated with animal food
is not tracked, not generally available, or not tracked accurately.
Some comments maintain that because animal food should not be covered
by the same risk-ranking model as human food, the RRM-FT cannot be used
to place animal food on the FTL.
    On the other hand, some comments assert that animal food should be
included on the FTL. These comments state that animal food was not
excluded from section 204(d) of FSMA, and they maintain that because
illness in both humans and animals has been attributed to animal food,
animal food should not be excluded from the subpart S requirements. One
comment maintains that tracing of animal feed could help ensure that
pathogens and bacteria are not introduced at the feed stage of the
supply chain.
    (Response 79) We agree with the comments asserting that animal food
should not be covered under the same risk-ranking model as human food.
Information on some of the key criteria used to develop the Model,
including factors specified by Congress in section 204(d)(2)(A) of
FSMA, does not exist for animal food. As discussed in the preamble to
the proposed rule, we do not at this time have reliable data sources or
ways to generate data related to animal illness caused by consumption
of animal food. In addition, the RRM-FT does not consider the variation
in species that would be needed, as risk of hazards may be species-
dependent and vary within a species, and can be dependent on the
animal's life stage or class of production (e.g., a dry dairy cattle
vs. a lactating dairy cow). For these reasons, the current RRM-FT is
not appropriate for animal food, and there are no animal foods on the
FTL. However, we may consider development of an animal food risk-
ranking model in the future.
    (Comment 80) Some comments ask that we confirm that animal food
made with food or the by-products of foods on the FTL is not subject to
the regulation.
    (Response 80) We agree that animal food that is made with food (or
by-products from production of food) on the FTL would not be subject to
the subpart S requirements.
    (Comment 81) Some comments ask us to use a formal notice and
comment process if we intend to update or develop a risk-ranking model
specific to animal food that would be used to place animal food on the
FTL.
    (Response 81) We intend to seek public input on an animal food
risk-ranking model if, in the future, we opt to develop such a model.
We have a variety of ways (e.g., public meeting, formal notice and
comment) we can seek public input if we were to undertake work on an
animal food risk-ranking model. Although we cannot commit to a specific
mechanism for obtaining public input, we are committed to seeking
public input on any potential risk-ranking model for animal food.
q. Foods Regulated by the USDA
    (Comment 82) Some comments ask for clarity on whether a multi-
ingredient food that is regulated by USDA's Food Safety and Inspection
Service (FSIS) but contains an FTL food as an ingredient would be
covered by the rule. The comment cites an as example a chicken salad
containing diced celery.
    (Response 82) As discussed in Response 76, we have provided clarity
on this topic by adding Sec.  1.1305(g) to the final rule. Section
1.1305(g) states that the subpart S requirements do not apply to
persons who manufacture, process, pack, or hold food on the FTL during
or after the time when the food is within the exclusive jurisdiction of
the USDA under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.),
the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg
Products Inspection Act (21 U.S.C. 1031 et seq.).
    Thus, when an FDA-regulated facility ships an FTL food to an
exclusively FSIS-regulated facility, the shipper must maintain and send
shipping KDEs to the FSIS facility in accordance with the final rule.
These records can be used by the FSIS facility if traceback of the food
products is necessary. KDEs are not required to be maintained by the
FSIS facility or any subsequent receivers of food from the FSIS
facility.
    While FDA maintains regulatory jurisdiction at retail for all
foods, including any food that contains an FTL food as an ingredient,
we are choosing not to exercise our authority in these specific
circumstances for the purposes of the final rule. The most successful
traceability efforts will have an unbroken chain of records. FDA does
not have the authority to impose recordkeeping requirements on
facilities that are under exclusive USDA jurisdiction. When an FTL food
is used as an ingredient in a food regulated by FSIS and tracing
records are not kept by the FSIS-regulated facility, the chain of
traceability records is broken, and it would be difficult for the RFE
that receives the food to maintain the required records. Therefore, we
are exempting from the subpart S requirements all persons who
manufacture, process, pack, or hold food on the FTL both during and
after the time when the food is within the exclusive jurisdiction of
the USDA.
    In the case of the specific example cited by the comment, chicken
salad would be regulated by FSIS and would not be subject to the FTL
traceability regulation, even if the chicken salad contains foods like
fresh-cut celery or fresh-cut onions that are on the FTL. However, the
supplier of the FTL food, such as fresh-cut celery or fresh-cut onions,
must maintain and send shipping KDEs to the chicken salad manufacturer.
If that chicken salad was subsequently used as an ingredient in another
product, such as a closed-faced sandwich, that is regulated by FDA, we
would still not consider that chicken salad sandwich to be covered by
the rule because the food was previously held in a facility that was
within the exclusive jurisdiction of the USDA.
    (Comment 83) One comment asks that we coordinate with the USDA and
consider covering animal proteins under

the FTL traceability regulation in the future.
    (Response 83) Some animal proteins, including beef, lamb, chicken,
turkey, and pork, are under the exclusive jurisdiction of the USDA at
certain points in the food production chain. Similar to our decision
regarding Siluriformes such as catfish (see Response 76), we chose not
to include these animal proteins in the Model because we would be
unable to ensure an unbroken chain of traceability records. Congress
directed FDA to coordinate with the USDA on section 204(d)(6)(A) of
FSMA related to farm to school and farm to institution programs, which
we have done, and we will continue to coordinate with the USDA as we
implement the final rule.
r. Root-Cause Analyses
    (Comment 84) One comment suggests that conducting more root-cause
analyses of foodborne illness outbreaks could provide additional
information useful for inclusion in the Model and may provide
additional clarity for certain commodity designations.
    (Response 84) We agree that root-cause analyses of outbreaks are an
important tool to help better understand how foods become contaminated
with certain pathogens. The RRM-FT used data available at the time we
developed the Model and produced the FTL. Results of some root-cause
analyses were available and considered when identifying food/hazard
pairs in the Model. For example, we reviewed some outbreaks for which
we were able to identify post-kill step contamination in processing
facilities as a root cause of the outbreak, and data concerning these
outbreaks were included in the Model. As we update the data for the
Model in the future, any additional available information from root-
cause analyses will be included.
s. Other Factors
    (Comment 85) Several comments urge us to consider additional
factors in developing the FTL, such as the fact that traceability
records are already required under subpart J; that food manufacturers
keep records under the regulation on preventive controls for human
food, some of which they argue may be traceability-related; and that
food manufacturers have greater insight into their supply chains as a
result of other FSMA regulations, including the preventive controls and
FSVP regulations.
    (Response 85) Congress required FDA to designate foods for which
additional traceability recordkeeping requirements are appropriate and
necessary to protect the public health, based on specific factors
outlined in section 204(d)(2)(A) of FSMA. While many food companies are
required to keep records under subpart J documenting the immediate
previous source and immediate subsequent recipient of their food, FSMA
directed FDA to develop a regulation requiring additional traceability
records for foods designated as high-risk. We recognize that food
processors must keep records under other regulations, but many of those
records are for purposes other than facilitating traceability. To meet
requirements under the FTL traceability rule, the final rule allows
firms to use records kept for other purposes and does not require firms
to duplicate existing records (see Sec.  1.1455(f)).
t. Hazards
    (Comment 86) One comment agrees with FDA's decision, as described
in the Designation of the FTL Memorandum (Ref. 5), to consider
biological hazards and acute hazards, and not chemical hazards related
to chronic exposure or food allergens, in developing the FTL. Another
comment cites reports about heavy metals in baby food and recommends
that we consider whether traceability records would be useful for
addressing chronic exposures to chemical hazards such as lead.
    (Response 86) We appreciate the comments that agree with the focus
on biological and acute hazards for the FTL traceability regulation.
Our traceability activities generally focus on foods contaminated with
biological or acute chemical toxins that present an immediate public
health risk. In contrast, enhanced recordkeeping for traceability would
not be similarly useful for addressing adverse health effects of
chronic exposure to chemical hazards such as lead or other toxic
elements. For food allergens, we have found that consumers with food
allergies usually can identify the food or ingredient that most likely
caused the allergic reaction, including the brand and packaging of the
food in most cases. We can then rapidly identify the source of the
allergen-containing food and take appropriate regulatory action.
Therefore, additional recordkeeping for traceability would not greatly
enhance our ability to identify and respond to undeclared allergens in
food. Therefore, we have determined that for the purposes of developing
the FTL, we will only consider results from the Model for microbial
hazards and acute chemical toxins.
u. Food Code
    (Comment 87) One comment notes that the foods on the FTL are
different from foods identified as potentially hazardous in the Food
Code. The comment maintains that this could be potentially confusing
for restaurants and restaurant employees. Therefore, the comment
suggests that the Food Code be updated to reflect the foods on the FTL
and that guidance for control of the hazards be provided.
    (Response 87) The Food Code is a separate program and modifications
to it are beyond the scope of this rulemaking. Changes to the Food Code
are made through the Conference for Food Protection, which has a
separate process for revisions and updates.

C. General Comments on the Proposal

    Many comments make general remarks supporting or opposing the
proposed rule without focusing on a particular proposed provision. In
addition, many comments address issues with the proposed rule that do
not involve a specific proposed provision or that concern multiple
provisions. In the following paragraphs, we discuss and respond to such
general comments.
1. General Support for and Opposition to the Proposed Rule
    (Comment 88) Many comments express general support for the proposed
rule. Some comments state that existing traceability recordkeeping
requirements are inadequate, current traceability capability in the
industry is lacking, and there is a need to modernize and standardize
traceability processes. Some comments suggest that the rule will: save
lives and reduce illnesses by enabling faster identification of
contaminated food and recipients of the food; help FDA conduct
investigations and enable the Agency to skip steps in the supply chain;
facilitate faster, more targeted recalls at lower cost and reduce broad
market withdrawals; reduce the number and frequency of public health
warnings and recall announcements; help consumers feel safer about the
food they eat by increasing the transparency between consumers and
producers; help prevent needless food waste when possibly unsafe
products must be discarded; yield improvements in inventory control and
firms' ability to keep accurate shipping and receiving records; prevent
underconsumption of FTL foods due to safety concerns; and reduce
liability damage costs to manufacturers. Several comments maintain that
the benefits of the rule,

including a reduced risk of adverse economic consequences for entities
in the supply chain, outweigh the costs of meeting the additional
recordkeeping requirements.
    On the other hand, many comments express opposition to the proposed
rule. One comment maintains that the rule would cause hardships for
producers and force more importation of food produced in less sanitary
systems. Several comments maintain that compliance with the rule would
be infeasible or too costly for many supply chain entities, including
many farms, producers, and RFEs, and that the costs of the rule would
outweigh its public health benefits. Some comments contend that the
rule would increase costs to consumers and limit consumers' ability to
obtain fresh, local food. Some comments assert that existing
traceability requirements are adequate and additional regulation of
farms and firms would be unnecessary and burdensome. Some comments
maintain that many common industry supply chain operations would not
fit within the proposed rule's framework for CTEs. Some comments
contend that the rule would create a barrier to firms looking to enter
the industry or the U.S. market, as well as to firms that are reluctant
to adopt technology. Some comments assert that while other FSMA rules
have essentially codified existing food safety best practices, the
proposed rule would create an entirely new and at times duplicative
recordkeeping system. Several comments claim that the rule assigns
demanding responsibilities to industry with little or no additional
safety benefits beyond existing controls.
    (Response 88) As directed by Congress in section 204(d)(1) of FSMA,
we are establishing additional traceability recordkeeping requirements
for foods we have designated as high-risk in accordance with the
criteria Congress specified in section 204(d)(2)(A) of FSMA. Consistent
with Congress' directive, we believe that the requirements of the final
rule will help the Agency better protect the public health by enabling
us to more rapidly and effectively identify recipients of a food to
prevent or mitigate foodborne illness outbreaks and address credible
threats of serious adverse health consequences or death. We believe
that the final rule addresses many of the limitations of the existing
traceability recordkeeping requirements in subpart J as discussed in
Response 105, and will help us respond more quickly and effectively to
foodborne illness outbreaks and recall events involving FTL foods,
which will benefit both public health and the food industry. As
discussed later in this document, the final rule includes several
changes to, and additional exemptions from, the proposed requirements
that we believe will reduce the burden of the rule on entities
throughout the supply chain while still producing the benefits of
faster and more efficient traceability. We note that the rule will
apply to imported FTL foods as well as domestically produced FTL foods,
and that the rule would not require duplication of records. Specific
comments relating to the costs and benefits of the rule are discussed
in Section VII of this document.
    (Comment 89) Some comments maintain that the rule would increase
the costs of production and cause the price of food to increase for
consumers and throughout the supply chain.
    (Response 89) The FRIA (Ref. 16) attempts to comprehensively
represent the total costs of compliance with the rule to industry and
society as a whole. Section II.F of the FRIA estimates compliance costs
to various covered domestic entities depending on their size and role
in the supply chain, and section II.H discusses costs to foreign
entities. However, we do not determine the exact incidence of those
costs, which might be passed on to other entities in the supply chain.
We acknowledge consumer concerns about food prices, but we do not think
that the rule will cause food and ingredient prices to rise
substantially, although depending on entities' market power some costs
of the rule might be passed all the way to consumers and retail buyers.
We believe that the exemptions and partial exemptions in the final rule
(see Section V.E of this document), along with the streamlining and
simplification of certain requirements (see Response 104), should help
to limit the potential impact of the rule on prices for ingredients and
final goods if some of the costs of the rule are passed on to consumers
and retail buyers.
    (Comment 90) Some comments assert that the rule would decrease food
availability because the difficulty of complying would force some small
producers to close. Some comments maintain that small operations have
proven key to local food security when larger operations have been
forced to temporarily shut down during emergencies, such as the COVID-
19 pandemic. Some comments assert that if small farms shut down there
will be reduced access to healthy food.
    (Response 90) We do not agree that the rule will substantially
reduce food availability, reduce access to healthy food, or force
businesses to close. The comments did not provide any evidence that
shutdowns would occur or that food access would be restricted because
of the rule. As previously discussed, we have made changes in the final
rule to reduce the chances that any business, especially smaller firms
and farms, will feel so burdened by the requirements that it must shut
down.
    (Comment 91) One comment asserts that the unintended consequences
of the rule could include increasing food waste from the elimination of
grocery returns.
    (Response 91) We disagree with the comment that the rule will
increase food waste by discouraging or eliminating grocery returns. The
rule does not create any recordkeeping requirements relating to the
sale of food to consumers or to the return of such food by consumers.
2. Treatment of Different Sizes and Types of Entities
    (Comment 92) Several comments assert that the rule favors and is
intended for larger entities in food supply chains. Some comments
contend that FDA failed to seek input on the proposed recordkeeping
requirements from smaller firms and farms. Some comments assert that by
unnecessarily burdening small businesses, the rule would further
encourage the consolidation of the food system, which the comments
maintain has led to more outbreaks. Some comments assert that many
smaller firms and farms lack the money, technology, and infrastructure
to meet the proposed requirements, and that the rule will have a more
severe impact on smaller firms that will need to develop a traceability
system from scratch. Some comments maintain that the cost of complying
with the rule will force many smaller firms out of business without any
corresponding benefit to the public health. Some comments assert that
many smaller retailers will stop doing business with local food vendors
because many of those small suppliers will be unable to meet the new
requirements. Some comments assert that the exemptions in the proposed
rule are overly narrow in scope or inappropriately targeted, so changes
are needed to ensure the rule can be feasibly implemented by smaller
entities.
    (Response 92) We do not agree that the final rule favors or is
intended for larger firms. As discussed later in this document, the
final rule includes several full and partial exemptions that apply to
smaller entities such as small farms, RFEs, and other entities,
including additional exemptions not included in the proposed rule. In
addition, we believe that all entities subject to the rule will be able
to meet

the requirements that apply to them. As discussed later in this
document, we have reduced the amount of information on CTEs that
entities are required to keep and to provide to their customers. And
although we encourage the use of electronic records and communications
for traceability, the final rule does not require electronic
recordkeeping or any technologies for records maintenance or supply
chain communications. Nevertheless, we understand that coming into
compliance with the final rule might pose more challenges for entities
with fewer resources and less experience in traceability, and we intend
to provide outreach and guidance to help smaller entities understand
and comply with the applicable requirements of the final rule. In
addition, in accordance with section 204(h) of FSMA, not later than 180
days after promulgation of this final rule we will issue a small entity
compliance guide (SECG) that explains the requirements of subpart S in
plain language, with the goal of assisting small entities, including
farms and small businesses, in complying with these new requirements.
    (Comment 93) Some comments assert that the proposed rule places an
undue burden on small farms, including those just above the proposed
exemption threshold; that small farms could not comply or would have
significant difficulty complying with the rule; and that the rule could
cause some small farms to go out of business and cause consolidation in
the industry. Some comments state that FDA should support small farms,
not burden them. Some comments provide the following reasons why the
rule would potentially hurt small farms: (1) the industry is already
overregulated, and the COVID-19 pandemic and the current state of the
economy mean any new burden will be difficult for small farms to bear;
(2) the proposed requirements are too numerous and too stringent; (3)
small farms would have to hire additional staff to keep the records, or
the rule would depress worker ``profits'' by forcing them to perform
additional unpaid recordkeeping work; (4) small farms do not have
electronic capabilities, especially in underserved (in electronic
infrastructure) geographic regions and in some religious communities;
(5) the requirements of the rule would be a barrier to entry and growth
for small-scale farms, and the rule would make it difficult for them to
compete with larger farms; and (6) many of the crops on the FTL are
mainstays of small farms. Some comments simply maintain that the rule
is overburdensome, while others ask that we exempt small farms or
small-scale farms from the rule, or simply not issue any final rule.
    (Response 93) We appreciate that this rule for the first time will
establish traceability recordkeeping requirements applicable to farms,
and that complying with the subpart S requirements may place a burden
on many smaller farms, particularly in the economic environment
accompanying the COVID-19 pandemic. We agree it is important to try to
reduce the burden of the rule on businesses that may have fewer
resources to apply to compliance, while minimizing the additional
health risk caused by consumer exposure to products that would
otherwise be covered by the regulation. Therefore, as discussed in
Section V.E.2 of this document, the final rule includes exemptions and
partial exemptions for smaller farms. Furthermore, as discussed in
Section V.I, the final rule streamlines the KDE requirements, including
by eliminating the proposed requirements for growers. Because of these
exemptions, revised KDEs, and the flexibility provided in the final
rule, we conclude that the rule will not establish significant barriers
to entry for farms or be the cause of significant consolidation in the
industry. Further, as discussed in Section V.U.4 of this document, we
will provide education, training, and technical assistance to farmers,
and we will be issuing materials, including an SECG, specifically aimed
at assisting smaller farms in complying with the requirements of this
rule.
    Regarding the comments about electronic capabilities, we note that
the only portion of the final rule that requires such capabilities is
the electronic sortable spreadsheet requirement in Sec.
1.1455(c)(3)(ii). Under Sec.  1.1455(c)(3)(iii)(A), farms with annual
sales of no more than $250,000 are exempt from this requirement.
Furthermore, under Sec.  1.1455(c)(3)(iv), FDA will withdraw a request
for an electronic sortable spreadsheet to accommodate a religious
belief of a person asked to provide such a spreadsheet.
    (Comment 94) One comment states that, in addition to exempting
small and medium producers and retailers, larger retailers should only
be required to obtain tracking information from very large producers so
as not to overburden small producers that would otherwise be exempt.
    (Response 94) We do not agree that large retailers should only have
to keep records of FTL foods obtained from very large producers, as
this could significantly reduce the traceability information available
to FDA in some circumstances. However, we recognize that when firms
obtain food from suppliers that are not subject to subpart S, they
might not receive certain information their supplier would be required
to provide if they were subject to the rule. Therefore, as discussed in
Section V.N.2 of this document, the final rule clarifies the
traceability information to be kept when a person receives an FTL food
from a person to whom subpart S does not apply.
    (Comment 95) Some comments assert that Congress recognized in the
2002 Bioterrorism Act that foods can be traced without imposing
requirements on the first or last links in the supply chain, i.e., the
farmer/rancher and the entity that sells or serves the food to the
consumer, and that Congress reaffirmed this approach to traceability in
FSMA. These comments also maintain that, in FSMA, Congress also
recognized the importance of protecting small and local food businesses
from expensive regulations not needed for small operations, and that
FDA incorporated this principle in adopting other regulations under
FSMA, such as the provisions for ``very small businesses'' in the
preventive controls regulation. The comments maintain that FDA is
contradicting these principles and imposing costly, burdensome
requirements on farms, RFEs, and very small businesses.
    (Response 95) We do not agree with the comments' characterizations.
Unlike the Bioterrorism Act traceability provisions (section 414(b) of
the FD&C Act), section 204(d)(1) of FSMA does not exclude entities at
the beginning (e.g., farms) or end (e.g., restaurants) of the supply
chain from the scope of the law. Rather, in referring to entities such
as farms and grocery stores, Congress recognized the importance of
ensuring traceability to both ends of the supply chain. With respect to
smaller businesses, the different components of FSMA were designed to
serve different food safety purposes, and they do not specify a uniform
approach to the application of implementing regulations to smaller
firms and farms. In any event, as discussed later in this document, the
final rule fully exempts from subpart S certain small food producers
and small RFEs and restaurants, and provides partial exemptions for
certain other smaller entities, as well as exemptions relating to short
supply chains.
    (Comment 96) Some comments maintain that the proposed requirements
should only be applied to large firms because foodborne illness
outbreaks are only a concern with large firms. One comment asserts that
the rule

could lead to an increase in foodborne illnesses since small firms
cause fewer illnesses and have the highest level of traceability, and
they will likely cease production due to the cost of compliance. Some
comments state that foodborne illness outbreaks are always traced back
to large farming operations, such as ``mega-farm'' facilities,
concentrated animal-feeding operations (CAFOs), monocrop operations,
and those that sell through aggregators and large distributors. One
comment suggests that small firms have every incentive to ensure their
foods are safe because their customers know the source of the products
and will make it known if their products cause illness. One comment
maintains that outbreaks only become a factor with central processing
facilities, where items from across the country are processed and
packaged, and that there is no reason to impose the recordkeeping
requirements on items with a short supply chain from producer to
consumer. One comment asserts that, although the rule is intended to
fix a problem caused by firms being too large to maintain healthy
standards, it will ruin the small producers who are not the source of
the problem.
    (Response 96) We do not agree with the comments that foodborne
illness outbreaks are only associated with larger food producers and
facilities, and the comments do not provide data to support this
assertion. Firm size does not change the characteristics of the food
(e.g., the potential for supporting pathogen growth). Nevertheless, as
stated in section V.E.2 of this document, the final rule includes
several exemptions and partial exemptions for smaller entities,
including those involved in shorter supply chains, and we do not
believe that the rule imposes an unnecessary or unreasonable burden on
those entities that are subject to these recordkeeping requirements.
    (Comment 97) Some comments suggest that most foodborne illnesses
result from contamination in the middle of the supply chain and ask
that the rule account for the lower risk associated with farms and
restaurants.
    (Response 97) As discussed in the preamble to the proposed rule (85
FR 59984 at 59990), point-of-service firms (foodservice and retail)
affect almost every traceback investigation FDA conducts because
information concerning consumer purchases from point-of-service firms
often is used to initiate a traceback. Coverage of RFEs and restaurants
is therefore a vital part of the subpart S requirements.
    By including section 204 in FSMA, Congress recognized the need for
improvement of food tracking and tracing generally and traceability
recordkeeping requirements in particular. In not excluding farms and
restaurants from the scope of these requirements, Congress also
recognized the importance of ensuring traceability to both ends of the
supply chain. While we realize that contamination in the middle of the
supply chain can result in foodborne illness outbreaks, in recent
years, numerous outbreaks that CORE has worked on related to FTL foods
have been linked to growers and other entities at the start of the
supply chain (Ref. 7). The requirements of this rule will help ensure
that the food industry maintains the traceability information we have
determined is needed to enable us to respond quickly and effectively to
foodborne illness outbreaks and recall events.
    While we continue to believe that traceability is important at the
beginning and end of the supply chain, we recognize that various full
or partial exemptions are appropriate to provide certain farms as well
as RFEs and restaurants with flexibility and/or relief in meeting the
subpart S requirements, while ensuring that appropriate measures are in
place to allow for efficient traceability activities when needed. These
full and partial exemptions are discussed in Section V.E of this
document.
    (Comment 98) One comment asserts that because many growers take on
a significant recordkeeping burden to comply with food safety
requirements at the request of their customers, FDA should ensure that
the subpart S requirements can easily integrate with a farm's existing
food safety protocols and complement rather than duplicate food safety
efforts already occurring in the marketplace.
    (Response 98) We agree with the comment. We believe that the
requirements in the final rule applicable to farms coordinate well with
food safety measures many farms have adopted in recent years in
response to the demands of their customers. In addition, as discussed
in Response 104, we believe the KDEs-for-CTEs recordkeeping approach
the final rule establishes is generally consistent with traceability
plans and systems in place in many supply chains. Moreover, as
discussed in Section V.E.2 of this document, smaller farms that might
be especially burdened by additional traceability requirements for FTL
foods are exempt from the final rule.
    (Comment 99) One comment maintains that the rule would penalize a
farm for being diversified and having total sales that prevent
exemption. The comment maintains that while the inclusion of an
exemption by reference to the produce safety regulation is laudable,
the rule would nevertheless have a disproportionate impact on
diversified farms.
    (Response 99) We do not agree that the rule has a disproportionate
or improper impact on diversified farms. In accordance with section
204(d)(1) of FSMA, the rule applies to persons who manufacture,
process, pack, or hold foods on the FTL. Although the fact that a farm
grows several different RACs might increase the chances that the farm
grows a RAC that is on the FTL, being subject to the rule with respect
to that FTL food would not constitute a penalty but rather the
appropriate application of the recordkeeping requirements Congress
concluded were necessary to protect against the risks posed by such
foods. Furthermore, if growing several crops enables a farm to achieve
a level of sales making it ineligible for exemption as a small
producer, the size of its earnings would make it less likely that
compliance with subpart S would pose an undue burden on the farm.
3. Application of the Rule to All Foods
    (Comment 100) Some comments suggest that the proposed traceability
recordkeeping requirements be applied to all foods, not just foods on
the FTL. One comment acknowledges that FSMA limited the additional
recordkeeping requirements to foods on the FTL but maintains that this
approach is flawed and suggests that it be reconsidered. One comment
asserts that FDA could have relied on other provisions of the FD&C Act
to more broadly apply the proposed traceability requirements, and they
encourage all food producers and processers to voluntarily follow the
final rule. One comment commends FDA for recommending adoption of end-
to-end digital traceability systems for all foods but recognizes that
the Agency is statutorily restricted from requiring traceability for
foods beyond those on the FTL.
    On the other hand, several comments raise concerns that firms may
have to keep traceability records for all foods, not just FTL foods,
based on supply chain pressures. One comment asserts that to ensure
compliance, some firms likely will request all information required
under the rule for receivers from all their suppliers, regardless of
whether the food or the supplier is exempt from the rule, which will
effectively force all manufacturers to comply with the rule's
requirements for shipping records. Some comments maintain that the rule
will indirectly affect non-FTL foods because many

firms will not have the capacity to operate two sets of recordkeeping
systems for their products. One comment asserts that the rule is not
feasible for the entire food sector and that it is unlikely that food
companies could voluntarily adopt this approach for many ingredients
not on the FTL. One comment asserts that the rule should not be applied
to all foods, adding that any future decision to extend additional
traceability recordkeeping requirements to non-high-risk foods would
depend on a decision by Congress to impose additional regulatory costs
throughout the food chain, including on segments that, according to the
comment, present no or limited risks.
    (Response 100) The subpart S requirements set forth in the final
rule apply only to persons who manufacture, process, pack, or hold
foods on the FTL; the rule does not apply to non-FTL foods. Section
204(d)(7) of FSMA states that the recordkeeping requirements FDA
establishes under section 204(d)(1) shall have no effect on foods that
the Agency has not designated as high-risk foods under section
204(d)(2), and that foods not so designated are subject solely to the
one-up, one-back recordkeeping requirements under section 414 of the
FD&C Act and subpart J of the regulations. In accordance with section
204(d)(7) of FSMA, subpart S does not impose any requirements with
respect to non-FTL foods.
    However, as stated in the preamble to the proposed rule, we believe
that applying to all foods the approach to recordkeeping required under
subpart S for FTL foods would benefit both industry and American
consumers by facilitating faster traceback and identification of
contaminated food, thereby limiting the adverse impact of an outbreak
on consumers and affected sectors of the food industry. Although we
acknowledge that conducting more robust recordkeeping for all foods
might not be feasible for all firms, especially those with fewer
resources to devote to traceability measures, we hope all entities in
the supply chain recognize the importance of subpart S's emphasis on
the documenting and sharing of lot code information as a product moves
through its supply chain.
4. Application of the Rule to Imported Foods
    (Comment 101) Some comments urge FDA to uphold a ``level playing
field'' by requiring both domestic and foreign firms to comply with the
traceability recordkeeping requirements for FTL foods. One comment
contends that once a product is manufactured and shipped, imported
product traceability details are no longer maintained; if the product
does not bear the imported product's traceability information, a
traceback to the point of origin and any root-cause analysis is
limited. The comment asserts that this lack of information could
subject domestic produce and produce growing areas to a product or
market recall even though all traceability rules are followed. One
comment states that, considering the potential expense incurred, it is
critical that both domestic and imported foods adhere to the same
traceability requirements.
    (Response 101) The requirements of the final rule apply to all
persons who manufacture, process, pack, or hold foods on the FTL
(unless an exemption applies), regardless of whether the person is in
the United States or a foreign country. It is possible that, with
respect to some imported FTL foods, the rule requires documentation of
the production of the food that not all importers or other entities
currently maintain, but they will be required to do so under subpart S.
For example, regardless of whether an FTL food is domestic or foreign
in origin, the rule requires that shippers of FTL foods provide
information on the traceability lot code source of the food and that
receivers of FTL foods record the traceability lot code source
information. In short, the final rule applies equally to domestic and
foreign persons who manufacture, process, pack, or hold FTL foods.
    (Comment 102) Two comments ask that we explain how the proposed
traceability requirements and the FSVP regulation differ.
    (Response 102) The subpart S traceability recordkeeping
requirements are designed to help FDA more quickly identify the source
of a foodborne illness outbreak and remove contaminated food from the
marketplace. These requirements apply to persons who manufacture,
process, pack, or hold foods on the FTL. The FSVP regulation (subpart L
of 21 CFR part 1), on the other hand, is designed to help ensure that
persons who import food into the United States verify that the foreign
supplier uses processes and procedures that provide the same level of
public health protection as the FDA requirements on standards for
produce safety and preventive controls for human and animal food, as
applicable, and to ensure that the food is not adulterated under
section 402 of the FD&C Act or misbranded with respect to labeling for
the presence of major food allergens under section 403(w) of the FD&C
Act. In short, while this final rule focuses on improving traceability
for both domestic and foreign foods on the FTL, the FSVP regulation is
intended to help ensure that importers take certain steps to verify,
before importing food, that the imported food meets applicable FDA food
safety requirements.
    (Comment 103) Several comments express concern about foreign
compliance with the rule, particularly because some foreign suppliers
of FTL foods might not know that their products will be exported to the
United States. The comments state that this would be especially
problematic because the proposed rule would require firms to pass
traceability lot codes forward through the supply chain while
prohibiting assignment or changing of codes except at initial packing
and transformation. The comments assert that the rule would be
burdensome because the requirements might be applied to products that
might not ultimately be exported to the United States. The comments
further maintain that complying with the rule would be practically and
technically difficult for many operations because they would need to
update their traceability systems to comply.
    (Response 103) FDA is aware that many firms, both domestic and
foreign, will have to update their traceability systems to comply with
the rule. However, we think the subpart S requirements are justified in
light of the benefits associated with more efficient and effective
tracing during foodborne illness outbreaks. Regarding the concern that
some foreign suppliers may have to provide traceability information for
products that, in the end, are not exported to the United States, U.S.
importers will need to work with their upstream suppliers in foreign
countries to ensure there is an understanding of the potential for
foods on the FTL list to be exported to the United States and the
traceability information required for these products. The final rule
provides flexibility in how this information is provided, which should
make maintenance and sharing of the information easier as firms can
decide the method that is best suited to their operations. We expect
that much of the information required to be provided to customers under
the rule is already being shared between trading partners, and firms
would not be required to duplicate those records to comply with the
rule.
5. Reduction and Simplification of Requirements
    (Comment 104) Many comments request that FDA simplify the proposed
recordkeeping requirements by reducing the number of CTEs for which
firms

must keep records and streamlining the number of KDEs they must record
for each CTE. Several comments claim that the proposed rule is
needlessly complex, overly prescriptive, and goes beyond what is
necessary for traceback purposes. Several comments maintain that the
required KDEs should be limited to information that is absolutely
necessary. Some comments assert that the rule would impose redundant
requirements or requirements of minimal value. Several comments assert
that the proposed CTE/KDE structure is too complex to understand how
the rule would apply to each food a firm handles. One comment maintains
that the burden this complexity will place on industry will detract
from the effectiveness of recordkeeping programs and prevent the rule
from achieving its intended public health benefit. Some comments
suggest that a simpler system would make the rule more readily
understandable and accurately implemented by industry at a lower cost.
Some comments assert that FDA could fulfill its statutory mandate and
achieve similar public health benefits through simpler and less costly
alternatives that leverage already successful traceability
recordkeeping systems, like those of foodservice distributors.
    (Response 104) We agree with the comments that the requirements of
the rule should be as simple and few as possible while still enabling
the rule to achieve its purpose of improving the traceability of FTL
foods. In response to comments, we have made several revisions to the
CTEs for which records must be maintained, and we have streamlined and
simplified the KDEs required to be kept and provided to the recipient
of shipped food. As discussed later in this document, for each of the
CTEs we have tried to streamline the KDEs so that they include only the
information we need to conduct timely and efficient investigations into
foodborne illness outbreaks, as well as information that firms must
provide to their customers to ensure consistency and enable them to
meet their requirements under subpart S. We believe the changes we have
made to the CTE/KDE requirements will make it easier for those persons
who are subject to the rule to understand and comply with the
applicable requirements, thereby making the rule more effective yet
less burdensome. The CTE/KDE approach in the final rule is generally
consistent with approaches taken by existing traceability programs,
which we think will assist with implementation. Where appropriate and
possible, we have revised or deleted proposed requirements to avoid
unnecessary burden, provided additional opportunities for flexibility,
and better aligned the requirements with current industry practices.
    (Comment 105) Some comments maintain that the rule should focus on
key gaps in the existing traceability recordkeeping requirements in
subpart J. One comment suggests that we amend subpart J to require
covered entities to maintain lot code information and asks us to
consider ways to combine the requirements of subpart J and proposed
subpart S to enhance traceability. Some comments assert that although
creating and maintaining traceability lot codes and linking the codes
throughout the supply chain are needed to fill gaps we have identified
in the subpart J requirements, we should issue guidance to address any
other shortcomings of these requirements rather than adopt new
requirements.
    (Response 105) We agree with the comments that the rule should
focus on addressing important gaps in the subpart J recordkeeping
requirements, and that is what we have done with subpart S. The
preamble to the proposed rule cites the lack of lot codes as a key
shortcoming of subpart J, and the final rule makes recording
traceability lot codes and providing them to customers as part of
certain CTEs a critical component of the subpart S requirements. The
final rule addresses another gap in the subpart J requirements by more
completely covering the sectors of the supply chain, from farms and
other food producers at the beginning of the chain to RFEs and other
entities at the end of the chain. Further, firms that are currently
complying with subpart J recordkeeping can use those records to satisfy
many of the subpart S requirements. Consistent with Congress' directive
to establish additional recordkeeping requirements for traceability,
and because the scope of subparts J and S are not the same, we
established a new regulation. We believe that putting these
requirements into a guidance, without also issuing a regulation, would
not be appropriate.
    (Comment 106) Several comments specify each of the KDEs they
believe are unnecessary or inapplicable to some or all FTL foods,
including such KDEs as the following: the entry number for imported
products; the category code/term, category description, brand name,
commodity, and variety; the physical location name; location
identifiers; the point of contact for lot code generators; the date and
time for a CTE; location information for where the CTE occurred; and
the name of the transporter.
    (Response 106) As stated in Response 104, we have made several
changes to the KDEs that must be kept and provided for each CTE in the
supply chain. We address the comments on which KDEs are appropriate and
necessary for each CTE in the individual sections of this document
concerning the relevant CTEs.
    (Comment 107) One comment objects to imposing different
requirements for different CTEs under the rule.
    (Response 107) We do not believe it would be appropriate to require
maintenance of the same KDEs for each supply chain event, as some
information is not available at all steps in the supply chain and some
entities are better suited than others to keep and provide information
for certain CTEs. Consequently, the final rule tailors the KDEs that
must be kept and provided for each CTE according to the information it
is reasonable and appropriate for entities to maintain to facilitate
effective traceability.
    (Comment 108) Several comments object to the proposed requirements
to provide certain traceability information to their customers for
certain CTEs, such as shipping. One comment asserts that the proposed
rule would require unnecessary repeated sharing of data, rather than
focusing on just one or a few responsible parties. One comment asserts
that the rule necessitates that trading partners repeatedly reshare
attributes associated with products, locations, and business entities
instead of acknowledging that those attributes are populated by one or
a few parties who are responsible for that data.
    (Response 108) We do not agree with the comments that it is
unnecessary to require certain entities in the supply chain to share
information with persons to whom they send FTL foods. As discussed more
fully below, the final rule requires entities that engage in certain
activities with respect to FTL foods (e.g., initial packing, receiving,
transformation) to keep records of certain KDEs so that this
information is available to FDA if necessary to assist in our
investigation of a foodborne illness outbreak. To help ensure that
these firms have the required information, the rule also requires for
certain CTEs (e.g., shipping) that firms provide information to persons
to whom they send the food. In many cases, firms already provide this
information to their customers in the normal course of business,
although perhaps not all firms provide all the KDEs specified in the
final rule. To the extent that any of the required information is
already being kept within a firm's record system, the firm does not
need to duplicate these existing records

to satisfy the requirements under subpart S. In addition, as discussed
below, the final rule includes changes designed to place responsibility
for the maintenance of certain records on the entities in the supply
chain that are best suited to the task.
    (Comment 109) Several comments suggest that FDA require firms to
pass forward two standardized pieces of information (not specified in
the comment) identifying the originator or creator of a product in a
method that does not require the disclosure of confidential business
information, rather than requiring an elaborate set of additional KDEs.
The comments maintain that such a requirement, coupled with adequate
enforcement of the subpart J requirements, would allow for effective
tracking and tracing of foods on the FTL. Alternatively, the comments
suggest that FDA allow use of a linking identifier already established
by the receivers and shippers--such as a purchase order (PO) number,