ensure that additional technology is not included as a requirement in
the final rule or encouraged in the preamble to the final rule.
    (Response 461) As stated in Response 460, the final rule does not
require the use of electronic records. Although we continue to
encourage all parts of the food industry to adopt electronic
recordkeeping for traceability, firms are not required to do so, and we
will not take any regulatory action against a firm for keeping required
subpart S records in paper form. (Indeed, Sec.  1.1455(a)(1) makes it
clear that we could not take any such action.) With respect to the
electronic sortable spreadsheet requirement in Sec.  1.1455(c)(3)(ii)
of the final rule, as discussed in Section V.R.3 of this document, this
provision requires that information on certain FTL foods be provided to
us in an electronic sortable spreadsheet format only in certain limited
circumstances involving an outbreak investigation, a product recall, or
some other public health threat; it does not require the maintenance of
records in electronic form. We also note that the final rule includes
exemptions from the sortable spreadsheet requirement (see Sec.
1.1455(c)(3)(iii)), which we have included in response to comments
arguing that smaller entities would have difficulty complying with this
requirement. This includes an exemption in Sec.  1.1455(c)(3)(iii)(A)
for farms with average annual sales of $250,000 or less (see Section
V.R.3 of this document).
    (Comment 462) One comment asks whether paper records would also be
required if a firm keeps records in electronic form.
    (Response 462) If a firm keeps records in electronic form, it is
not also required to keep paper versions of those records. Under Sec.
1.1315(a)(1), a firm's traceability plan must include a description of
the procedures the firm uses to maintain the required subpart S
records, including the format and location of such records. When FDA
makes a records request under Sec.  1.1455(c), we will expect the
records to be in the format described in the traceability plan. If the
traceability plan states that the firm maintains its records
electronically and the firm provides us with electronic records, we
would not expect to also be provided with paper records.
    (Comment 463) One comment requests clarity on what information
firms will be required to made available to FDA vs. what must be shared
with the supply chain.
    (Response 463) All records required under the rule must be made
available to the Agency upon request in accordance with Sec.  1.1455.
This includes the traceability plan that is described in Sec.  1.1315,
the records of CTEs that are described in Sec. Sec.  1.1325 through
1.1350, and (under specified circumstances) the sortable spreadsheet
that is described in Sec.  1.1455(c)(3)(ii).
    The only information that is required to be shared within the
supply chain is the information for which this is explicitly stated in
the rule.

Specifically, certain information must be provided to other entities in
the supply chain by harvesters and coolers of FTL foods in accordance
with Sec.  1.1325(a)(2) and (b)(2) (see Section V.J of this document)
and by shippers in accordance with Sec.  1.1340(b) (see Section V.M of
this document).
    (Comment 464) Some comments urge us to provide a written request
that includes the specific records that we request.
    (Response 464) As further discussed below, we have concluded that
in the exigent circumstances described in Sec.  1.1455(c)(3), it may be
necessary for us to make a records request by phone. Section
1.1455(c)(3)(i) specifies that if the request is made by phone, we will
also provide the request to the firm in writing if asked to do so by
the firm. For requests that are made in person--either under the
exigent circumstances described in Sec.  1.1455(c)(3) or during a
routine inspection--we will work with the firm to ensure that the
request is understood, including by providing the request in writing as
needed.
2. Establishment and Maintenance of Records by Another Entity
    We received several comments asking whether third parties may keep
records on behalf of a covered entity. In response to the comments, we
are adding a provision to the codified (in Sec.  1.1455(b)) concerning
establishment and maintenance of records by another entity, as
discussed in the following paragraphs.
    (Comment 465) One comment requests clarity on the ability of
previous handlers of the food to maintain records on an entity's behalf
with the understanding that the records must be accessible within 24
hours. Some comments express appreciation for FDA indicating in the
preamble to the proposed rule that firms can enter into agreements with
a third party to create records for them. One comment maintains that
such agreements would be a viable option for entities that only hold
FTL foods but do not own them. One comment asks if a shipper could
maintain records of a product specifically grown for that shipper, or
if both the grower and shipper had to maintain the records. Some
comments request that we adopt a provision to accommodate agreements to
keep records on behalf of entities subject to subpart S.
    (Response 465) As stated in the preamble to the proposed rule (85
FR 59984 at 60004), we believe it is appropriate that persons subject
to subpart S be allowed to enter into agreements with individuals or
firms to create and keep the records they are required to maintain
under the rule, including, but not limited to, records documenting KDEs
for the CTEs the person performs. As we stated, this might entail firms
hiring consultants or other outside entities to conduct their required
recordkeeping, or relying on supply chain partners such as brokers or
suppliers to establish and maintain records on their behalf. In
response to comments requesting further clarity on this topic, Sec.
1.1455(b) of the final rule specifies that a person subject to subpart
S may have another entity establish and maintain records required under
subpart S on that person's behalf, although the person subject to
subpart S requirements is responsible for ensuring that such records
can be retrieved and provided onsite within 24 hours of request for
official review. In addition, it should be noted that if a person
covered by the rule has another entity establish and maintain required
subpart S records on its behalf, the covered person must include
information on the arrangement in its traceability plan in accordance
with Sec.  1.1315(a)(1).
    In response to the question about shippers maintaining records of a
product grown specifically for the shipper, we note that the final rule
no longer has requirements for the CTE of growing. However, Sec.
1.1455(b) allows for the flexibility to make arrangements for any
entity to establish and maintain records on behalf of a covered entity,
as described above. This could include, for example, an arrangement
between a shipper (who may also be the initial packer) and a harvester
under which the shipper maintains the required harvesting records under
Sec.  1.1325(a) on behalf of the harvester. If requested by FDA, it
would still be the responsibility of the harvester to make the records
available within 24 hours.
3. Record Availability (Sec.  1.1455(c))
a. Making Records Available Within 24 Hours of Request
    We proposed to require that persons make all records required under
subpart S available to an authorized FDA representative as soon as
possible but not later than 24 hours after the request (proposed Sec.
1.1455(b)(1)).
    On our own initiative, we have added a clarification that records
must be made available to an authorized FDA representative ``upon
request.'' We also have added a requirement that, in addition to
records required under subpart S, firms must make available any
information needed to understand the records, such as internal or
external coding systems, glossaries, abbreviations, and a description
of how the records the firm provides correspond to the information
required under subpart S. We conclude that it is more appropriate that
this information be provided in response to our requests to review
records under Sec.  1.1455(c) rather than maintained as a part of a
firm's traceability plan (formerly ``traceability program records''),
as would have been required under proposed Sec.  1.1315(a)(4).
    In response to comments received, we have made other changes to
proposed Sec.  1.1455(b)(1) (finalized as Sec.  1.1455(c)(1)), as
discussed in the following paragraphs.
    (Comment 466) One comment asserts that the proposed rule would
permit FDA to request records only after a foodborne illness outbreak
has occurred, limiting an entity's incentive to comply with the
requirements of the rule and reducing FDA's ability to conduct an
effective traceback in the event of an outbreak. The comment maintains
that firms would be more likely to comply with the regulations if FDA
were granted the authority to inspect records on a periodic basis. The
comment further asserts that periodic inspections would help ensure the
accuracy and efficiency of traceback investigations, which would
improve public health, limit the scope of recalls, and limit
unnecessary disposal of food.
    (Response 466) The comment misunderstands the proposed rule, which
stated (in proposed Sec.  1.1455(b)(1)) that covered entities must make
all records required under subpart S available to an authorized FDA
representative as soon as possible but not later than 24 hours after
the request. That provision was not limited to outbreak situations.
Similarly, under Sec.  1.1455(c)(1) of the final rule, FDA may request
review of a firm's subpart S records at any time, regardless of whether
we have reason to believe that the firm might have handled an FTL food
suspected of being a source of a foodborne illness outbreak. This is in
keeping with section 204(d)(1)(H) of FSMA, which states that this
rulemaking must allow covered entities to maintain the required records
at a central or reasonably accessible location provided that such
records can be made available to FDA not later than 24 hours after the
Agency's request.
    We agree with the comment that periodic inspections of traceability
records can have a positive impact on public health by ensuring that
covered entities are appropriately maintaining the required records
such that they will be available and complete when needed during a
traceback investigation. As

discussed in Section V.U of this document, we expect to conduct routine
records inspections to ensure that entities subject to the final rule
are satisfying the rule's requirements.
    We note that Sec.  1.1455(c)(3) (discussed below) contains specific
requirements that would only apply in the event of a foodborne illness
outbreak, recall, or other public health threat. This includes the
electronic sortable spreadsheet requirement set forth in Sec.
1.1455(c)(3)(ii). Thus, covered entities would only be required to
provide FDA with an electronic sortable spreadsheet during the
circumstances described in Sec.  1.1455(c)(3). During a routine
inspection that does not meet the conditions described in Sec.
1.1455(c)(3), a covered entity would not be required to provide FDA
with an electronic sortable spreadsheet.
    (Comment 467) Some comments ask that any request we make for
traceability records maintained by a foreign entity and related to an
imported food be communicated through the U.S. importer of the food.
The comments express concern that we will place direct responsibility
on foreign entities to comply with reporting obligations.
    (Response 467) We decline this request. For the subpart S
requirements to function as intended, all covered supply chain
entities, both domestic and foreign, must maintain and provide
traceability information as required under the rule. FDA may conduct
onsite inspections of foreign entities to determine compliance with
regulatory requirements, including those in subpart S, and we may
communicate directly with foreign entities during our evaluation of
inspectional outcomes or corrective actions. During an outbreak
investigation involving an FTL food, we might seek to obtain
information directly from foreign entities in the food's supply chain,
through the U.S. importer of the food, or through other means. All
entities in the supply chain who manufacture, process, pack, or hold
the FTL food, whether foreign or domestic, will need to determine how
they will maintain required records and make them available to us upon
request (unless the entity is subject to an exemption). As previously
stated, Sec.  1.1455(b) of the final rule allows firms to have another
entity establish and maintain subpart S records on their behalf,
although covered firms remain responsible for ensuring that the records
are provided onsite to us within 24 hours of our request for the
records. Thus, foreign entities may enter into an agreement with their
U.S. importer or another entity to maintain records on their behalf,
while remaining responsible for compliance with applicable subpart S
requirements.
    (Comment 468) Several comments request that the rule allow 48 hours
rather than 24 hours in which to make requested records available.
    (Response 468) We continue to believe that in most cases 24 hours
is an adequate length of time in which to make requested subpart S
records available to us, and we note that this is in keeping with
section 204(d)(1)(H) of FSMA, which states that this rulemaking must
allow covered entities to maintain the required records at a central or
reasonably accessible location provided that such records can be made
available to FDA not later than 24 hours after the Agency's request.
However, we recognize that additional time might be appropriate in
certain situations, such as when we are requesting a particularly large
volume of records. Therefore, Sec.  1.1455(c)(1) of the final rule
specifies that records must be made available to us within 24 hours
after our request or within some reasonable time to which FDA has
agreed. Similar language has been added to Sec.  1.1455(c)(3), which
addresses records requests that are necessary to help FDA prevent or
mitigate a foodborne illness outbreak, or to assist in the
implementation of a recall, or to otherwise address a threat to the
public health. As discussed below, in the circumstances described in
Sec.  1.1455(c), the 24-hour time period can begin with a remote
request (e.g., a request made by phone).
    (Comment 469) Some comments ask who is responsible for providing
records to FDA and who will receive records at FDA.
    (Response 469) The covered entity who receives a request for
records from FDA is responsible for providing the records they are
required to maintain under the rule. It is possible that we might
request records for a particular FTL food from multiple covered
entities in the same supply chain. Regardless of whether or not this is
the case, each entity of whom we request records is required to provide
us with the records they are required to maintain under subpart S. We
will provide the firm from which we request records with a point of
contact for submitting the records to us, as we currently do when we
request records from industry. In many situations the point of contact
is the local FDA office, but in some cases in might be the offices of
our regulatory partners, such as a State regulatory agency. In
accordance with section 204(c) of FSMA, we intend to establish a
product tracing system for the receipt of food traceability
information, which could include an electronic portal for the
submission of information to the Agency.
b. Offsite Storage of Records
    We proposed that offsite storage of records would be permitted if
such records can be retrieved and provided onsite within 24 hours of
request for official review, and that electronic records would be
considered onsite if they are accessible from an onsite location
(proposed Sec.  1.1455(b)(2)). We did not receive any comments on this
provision and are finalizing it (in Sec.  1.1455(c)(2)) as proposed.
c. Provision of Electronic Sortable Spreadsheet in Outbreak/Recall/
Public Health Threat Situation
    In Sec.  1.1455(b)(3), we proposed to require, when necessary to
help FDA prevent or mitigate a foodborne illness outbreak, or to assist
in the implementation of a recall, or to otherwise address a threat to
the public health, including but not limited to situations where FDA
has a reasonable belief that an article of food (and any other article
of food that FDA reasonably believes is likely to be affected in a
similar manner) presents a threat of serious adverse health
consequences or death to humans or animals as a result of the food
being adulterated under section 402 of the FD&C Act or misbranded under
section 403(w) of the FD&C Act, that entities must make available,
within 24 hours of request by an authorized FDA representative, an
electronic sortable spreadsheet containing the information in the
records they are required to maintain under subpart S, for the foods
and date ranges specified in FDA's request. We also proposed that we
would withdraw a request for such a spreadsheet when necessary to
accommodate a religious belief of a person asked to provide such a
spreadsheet.
    In response to comments received, we have made several changes to
these proposed requirements, including exempting certain small entities
from the requirement to provide an electronic sortable spreadsheet, as
discussed in the following paragraphs.
    (Comment 470) Many comments state that producing and providing an
electronic sortable spreadsheet to FDA within 24 hours would be
prohibitively difficult for entities of all sizes. One comment
maintains that compiling location data into an electronic sortable
spreadsheet in 24 hours is particularly burdensome. One comment
maintains that the 24-hour deadline could result in data errors. Some
comments urge us to create a mechanism by which industry

can request additional time to make the information available,
particularly if the records request is large; alternatively, these
comments ask that we consider prioritizing what information might be
made available to us most quickly for a large request. Some comments
recommend either removing the requirement entirely or providing more
time to provide the spreadsheet. One comment asks that we consider
exercising enforcement discretion regarding this requirement when
entities make a good faith effort to comply in a timely manner.
    (Response 470) As discussed in the preamble to the proposed rule
(85 FR 59984 at 60018), we believe that the electronic sortable
spreadsheet requirement will be one of the most effective ways to
improve the speed and efficiency of our traceback efforts during a
foodborne illness outbreak or other threat to public health. We will
only request an electronic sortable spreadsheet when we conclude that
obtaining the information in this format is necessary to help us
prevent or mitigate a foodborne illness outbreak, assist in
implementation of a recall, or otherwise address a threat to the public
health, and we will only request information on the FTL foods that may
be associated with the outbreak, recall, or other threat to public
health.
    We believe 24 hours generally is a reasonable timeframe in which to
provide a requested electronic sortable spreadsheet given the limited
circumstances, limited scope, and urgent nature of these requests. Such
spreadsheets can be created using software that is readily available
and commonly used for other general business purposes. However, in some
circumstances we agree it may be appropriate to provide a firm with
additional time to make the electronic sortable spreadsheet available
to FDA. For a large records request, for example, a firm that does not
maintain records electronically may need to manually enter a
considerable amount of information into such software to create an
electronic sortable spreadsheet. We agree that it may be reasonable for
FDA to extend the 24-hour timeframe in such circumstances, for some or
all of the information we request. Therefore, Sec.  1.1455(c)(3) of the
final rule specifies that, as under Sec.  1.1455(c)(1), the information
requested in these exigent circumstances must be made available to us
within 24 hours or within some reasonable time to which FDA has agreed.
In determining what timeframes are reasonable, we will consider the
specific circumstances, including an entity's effort to comply in a
timely manner.
    However, we recognize that some smaller entities may be less likely
to have the resources to produce the traceability information requested
in these exigent circumstances in an electronic sortable spreadsheet
format. Therefore, we are exempting certain smaller entities, including
certain smaller farms, RFEs, restaurants, and other entities, from the
requirement to provide the requested information in an electronic
sortable spreadsheet. To make clear what information must be included
in an electronic sortable spreadsheet while specifying that certain
smaller entities may provide this information in a different form,
Sec.  1.1455(c)(3)(ii) provides that except as specified in Sec.
1.1455(c)(3)(iii) and (iv), when the information FDA requests under
Sec.  1.1455(c)(3) is information a person is required to maintain
under Sec. Sec.  1.1325 through 1.1350 (i.e., records of CTEs), the
person must provide the information in an electronic sortable
spreadsheet, along with any other information needed to understand the
information in the spreadsheet. Under Sec.  1.1455(c)(3)(iii), a person
may provide the information we request under Sec.  1.1455(c)(3) in a
form other than an electronic sortable spreadsheet if they are:
     A farm whose average annual sum of the monetary value of
their sales of RACs and the market value of RACs they manufacture,
process, pack, or hold without sale (e.g., held for a fee) during the
previous 3-year period is no more than $250,000 (on a rolling basis),
adjusted for inflation using 2020 as the baseline year for calculating
the adjustment (Sec.  1.1455(c)(3)(iii)(A));
     An RFE or restaurant with an average annual monetary value
of food sold or provided during the previous 3-year period of no more
than $1 million (on a rolling basis), adjusted for inflation using 2020
as the baseline year for calculating the adjustment (Sec.
1.1455(c)(3)(iii)(B)); or
     A person (other than a farm, RFE, or restaurant) whose
average annual sum of the monetary value of their sales of food and the
market value of food they manufacture, process, pack, or hold without
sale (e.g., held for a fee) during the previous 3-year period is no
more than $1 million (on a rolling basis), adjusted for inflation using
2020 as the baseline year for calculating the adjustment (Sec.
1.1455(c)(3)(iii)(C)).
    Entities not required to make the requested information available
to us in an electronic sortable spreadsheet format must provide the
information in a different form, such as paper records or electronic
records that are not compiled in a sortable spreadsheet. For firms that
are not exempt from the electronic sortable spreadsheet requirement in
Sec.  1.1455(c)(3)(ii), we intend to provide guidance and technical
assistance to help entities comply, including potentially providing an
electronic template for entering information into a sortable
spreadsheet format.
    (Comment 471) One comment requested flexibility for the requirement
to provide electronic records to the FDA for firms that, for religious
reasons, do not use electronic recordkeeping.
    (Response 471) As indicated in proposed Sec.  1.1455(b)(3), we
agree that it is appropriate to accommodate the religious beliefs of
persons asked to provide an electronic sortable spreadsheet. Therefore,
the final rule specifies that we will withdraw a request for an
electronic sortable spreadsheet under Sec.  1.1455(c)(3)(ii), as
appropriate, to accommodate a religious belief of a person asked to
provide such a spreadsheet (Sec.  1.1455(c)(3)(iv)).
    (Comment 472) One comment states that the electronic sortable
spreadsheet requirement in proposed Sec.  1.1455(b)(1)(3) violates
section 204(d)(1)(E) of FSMA, which states that the recordkeeping
requirements for FTL foods must not require the creation and
maintenance of duplicate records where the information is contained in
other company records kept in the normal course of business. The
comment maintains that because the electronic sortable spreadsheet
would have to be provided within 24 hours of request, some firms might
be concerned with their ability to assemble such a spreadsheet in that
timeframe and might therefore consolidate their records daily to be
prepared for the possibility of a request, thereby creating duplicate
records.
    (Response 472) We do not agree that the electronic sortable
spreadsheet requirement necessitates the creation and maintenance of
duplicate records. FDA may request an electronic sortable spreadsheet
containing information on certain FTL foods in the limited exigent
circumstance specified in Sec.  1.1455(c)(3). Firms are not required to
prepare an electronic sortable spreadsheet daily or to otherwise
consolidate or duplicate records in preparation for such a request.
While we encourage firms to prepare for having to respond to a request
for an electronic sortable spreadsheet under Sec.  1.1455(c)(3)(ii),
including maintaining their records in an organized manner to
facilitate the preparation of such a spreadsheet, we do not anticipate
that firms will choose

to maintain their subpart S records in one manner and then duplicate
those records each day to be prepared for a spreadsheet request from
FDA.
    (Comment 473) One comment asks what information each firm will
receive from FDA (e.g., during an outbreak investigation) to use for
looking up the records they must include in their electronic sortable
spreadsheet. Some comments suggest that our implementation of the rule
should limit the scope of information requested and the number of
requests.
    (Response 473) Under Sec.  1.1455(c)(3), when necessary to
facilitate an outbreak investigation, assist in a recall, or otherwise
address a threat to the public health, FDA will specify the particular
FTL foods for which we need to review CTE/KDE records, focusing on
particular dates on which the food was handled and/or particular
traceability lot codes of such foods. Our request will make clear the
specific foods and the date ranges (or traceability lot codes) for
which we seek required traceability information. We will strive to
tailor the information request as much as possible so that firms can
focus their efforts on the most relevant information. As discussed
below, we have concluded that in the exigent circumstances described in
Sec.  1.1455(c)(3), it may be necessary for us to make a records
request by phone. Section 1.1455(c)(3)(i) specifies that if the request
is made by phone, we will also provide the request in writing upon the
firm's request; however, the firm must provide the requested
information within 24 hours (or within some reasonable time to which
FDA has agreed) of the phone request. For requests that we make in
person, we will work with the firm to ensure that the request is
understood, including by providing the request in writing as needed.
    (Comment 474) Several comments ask that we clarify how we will
request an electronic sortable spreadsheet containing the required
information. Some comments ask whether we will make the request
verbally or in writing. One comment asks that we clarify how an
electronic sortable spreadsheet containing the information we request
may be made available to FDA.
    (Response 474) We have revised the proposal to specify that our
request for information under Sec.  1.1455(c)(3) of the final rule may
be made in-person or remotely (e.g., by phone) by an authorized FDA
representative. In addition, Sec.  1.1455(c)(3)(i) specifies that if
our request for the information specified in Sec.  1.1455(c)(3) is made
by phone, we will also provide the request in writing upon request;
however, the requested information must be provided within 24 hours (or
within some reasonable time to which FDA has agreed) of the phone
request. This is the case for any information we request under the
exigent circumstances described in Sec.  1.1455(c)(3), even if we are
not requesting that the information be provided in an electronic
sortable spreadsheet (e.g., if the entity is exempt from the electronic
sortable spreadsheet requirement under Sec.  1.1455(c)(3)(iii)).
    We are currently considering various mechanisms by which electronic
sortable spreadsheets, as well as digitized records and other requested
information, can be made available to FDA. Approaches under
consideration include sending requested information to a dedicated
email box or through an online reporting mechanism, such as a web-based
portal to allow for submission of traceability information that we
might create in accordance with section 204(c) of FSMA (see Response
522). A request for records under Sec.  1.1455(c)(3) will specify how
the information may be shared with FDA. In addition, we expect to issue
communication on how firms may make electronic sortable spreadsheets
and records (whether in paper or electronic form) available to FDA.
    (Comment 475) Some comments ask that we clarify when the 24-hour
deadline associated with the electronic sortable spreadsheet
requirement begins.
    (Response 475) Under Sec.  1.1455(c)(3) of the final rule, the 24-
hour period (or other reasonable time to which FDA has agreed) in which
the requested information must be provided begins when we issue the
request, whether we do so in person or remotely (e.g., by phone).
    (Comment 476) Some comments assert that use of electronic
spreadsheets might compromise data quality and impede analysis. The
comments suggest that we specify a structured data format such as
Extensible Markup Language (XML) or JavaScript Object Notation (JSON)
to maintain accuracy and data integrity during large-scale information
exchange.
    (Response 476) We do not agree that use of an electronic sortable
spreadsheet will adversely affect the quality of firms' data or our
ability to analyze the data. Although there is a potential for human
error for firms that input information from paper records into an
electronic spreadsheet, we do not believe this will be a particularly
difficult or complex process, and any accuracy concerns will be far
outweighed by the benefits of having access to comprehensive
information in a sortable manner, considerably enhancing our ability to
analyze the data more quickly and effectively. As discussed in Response
400, one of the KDEs that we may request as part of the electronic
sortable spreadsheet is the reference document type and number for a
given CTE. This information will allow us to refer back to the original
reference document (whether paper or electronic) where the information
was maintained, which may help reconcile any data errors that may occur
in the spreadsheet.
    We agree that structured data formats promote data accuracy and
integrity, especially during large-scale information exchange. We will
take this into consideration as an option as we work to develop a range
of methods for providing the data required in the electronic sortable
spreadsheet to FDA.
d. English Translation of Records in Another Language
    We proposed in Sec.  1.1455(b)(4) that upon FDA request, a person
subject to the rule must provide within a reasonable time an English
translation of records maintained in a language other than English. On
our own initiative, we are adding language to clarify that proposed
Sec.  1.1455(b)(4) (which is finalized as Sec.  1.1455(c)(4)) refers
only to records required under subpart S. We are otherwise finalizing
the provision as proposed.
    (Comment 477) One comment asserts that we made assumptions that
downplay the complexity of the supply chain in putting together supply
chain examples. The comment asserts that we assumed any required KDEs
would be in English or easily understood as information passes through
the supply chain, and maintains that some foods on the FTL,
particularly seafood, move through many countries where English is not
the first language.
    (Response 477) For the purposes of creating supply chain examples,
we chose to provide examples in which all the KDEs were maintained in
English. However, covered entities may keep records required under
subpart S in any language, provided that, in accordance with Sec.
1.1455(c)(4) of the final rule, the entity can make available to us
within a reasonable time an English translation of subpart S records
that are maintained in another language. Records in a language other
than English have to be translated into English only if we request such
a translation. We recognize that the fact that subpart S records may be
maintained in any language may necessitate that firms work with their
supply chain partners to ensure that information provided (such as by
shippers to their customers) is readily

understood, but the need to understand information from other supply
chain entities exists regardless of traceability recordkeeping
requirements.
4. Record Retention
    We proposed to require, except as specified otherwise in subpart S,
that persons subject to the rule maintain records containing the
information required by subpart S for 2 years from the date the person
created the records (proposed Sec.  1.1455(c)). We are finalizing this
provision at Sec.  1.1455(d), with one minor edit as described below.
    (Comment 478) One comment recommends that FDA require only the
program records to be maintained for 2 years. The comment suggests that
all other traceability records should only be maintained for 1 year.
    (Response 478) We decline to make this change. As stated in the
preamble to the proposed rule (85 FR 59984 at 60018), although a highly
perishable food might pose a risk to consumers for only a few weeks,
illnesses caused by a contaminated food can be linked retrospectively
to past illnesses through whole genome sequencing (WGS) and other
evidence months or even years after the food was sold. Exposure and
consumption information collected from illness cases can be compared to
information from past cases of illness with the same WGS pattern, and
having access to traceability records for the food for up to 2 years
after the records were created could greatly aid our investigation into
an illness outbreak involving the food. In addition, reviewing food
production records up to 2 years old could help us determine whether a
current foodborne illness outbreak was part of a long-standing
contamination problem with a food or firm. There are also some foods on
the FTL with a long shelf life, such as various frozen seafood
products. Therefore, Sec.  1.1455(d) of the final rule requires that,
except as specified otherwise in subpart S (e.g., records maintained by
an RFE or restaurant that is subject to the partial exemption in Sec.
1.1305(j) because they purchase food directly from a farm), persons
subject to the rule must maintain records containing the information
required by subpart S for 2 years from the date the entity created or
obtained the records. (On our own initiative, we added the reference to
records ``obtained'' to reflect that in some situations firms may rely
on records they receive from others rather than creating the records
themselves.)
5. Electronic Records
    We proposed to specify that records that are established or
maintained to satisfy the requirements of subpart S and that meet the
definition of electronic records in 21 CFR 11.3(b)(6) are exempt from
the requirements of part 11 (21 CFR part 11), which concern electronic
records and signatures (proposed Sec.  1.1455(d)). We further proposed
that records that satisfy the requirements of subpart S, but that also
are required under other applicable statutory provisions or
regulations, remain subject to part 11, if not otherwise exempt. We did
not receive any comments on these provisions and are finalizing them
(at Sec.  1.1455(e)) as proposed.
6. Use of Existing Records and Multiple Sets of Records
    We proposed to require that persons subject to the rule do not need
to duplicate existing records (e.g., records kept in the ordinary
course of business or maintained to comply with other Federal, State,
Tribal, territorial, or local regulations) if they contain the
information required by subpart S (proposed Sec.  1.1455(e)). We
further proposed that a covered person may supplement any such existing
records as necessary to include all of the information required by
subpart S. Finally, we proposed that persons do not have to keep all of
the information required by subpart S in one set of records, but they
must indicate the different records in which the information is kept in
accordance with proposed Sec.  1.1315(a)).
    In Sec.  1.1455(f) of the final rule, we are finalizing the
provisions on the use of existing records as proposed. On our own
initiative, we have moved the provision on the use of more than one set
of records to a new paragraph, Sec.  1.1455(g), and revised it to align
with changes we are making regarding traceability plans in Sec.
1.1315. Therefore, Sec.  1.1455(g) specifies that a person subject to
subpart S does not have to keep all of the information required by this
subpart in a single set of records; however, the person's traceability
plan must indicate the format and location of the records the person is
required to keep under the subpart, in accordance with Sec.
1.1315(a)(1).
    (Comment 479) Several comments request that FDA allow firms to
leverage existing records.
    (Response 479) We agree with the comments. Under Sec.  1.1455(f) of
the final rule, firms may use existing records they keep for other
purposes to meet the requirements applicable to them under subpart S,
provided those records contain the required information.
    (Comment 480) One comment urges us to coordinate with other
government and non-governmental agencies to identify existing practices
and records that might also satisfy traceability requirements.
    (Response 480) As stated in Response 536, FDA coordinates with
State and other Federal agencies, where appropriate, in conducting its
traceability operations. However, persons subject to the rule are
responsible for keeping and providing the records required under
subpart S. As previously stated, Sec.  1.1455(f) allows firms to use
records they keep in accordance with other regulations or for any other
purposes to meet their applicable recordkeeping requirements under the
final rule.
7. Public Disclosure
    We did not propose requirements related to public disclosure but
have added Sec.  1.1455(h) to the final rule in response to comments.
    (Comment 481) One comment asserts that FDA has a duty to protect
from the disclosure of a company's trade secret or confidential
commercial information under section 414(c) of the FD&C Act and
questions whether we will be able to prevent disclosure if a Freedom of
Information Act (FOIA) request is made for information related to
subpart S. The comment requests that FDA explain how we intend to
protect information from disclosure under FOIA.
    (Response 481) FDA protects confidential information from
disclosure in accordance with all applicable statutes and regulations,
including 5 U.S.C. 552(b)(4), 18 U.S.C. 1905, and part 20. Consistent
with other FSMA regulations, we have added Sec.  1.1455(h), which
states that records obtained by FDA in accordance with subpart S are
subject to the disclosure requirements under part 20. This provision
makes clear that traceability records that are provided to FDA under
subpart S are subject to the information disclosure requirements in
part 20, including, but not limited to, provisions protecting against
the public disclosure of information concerning trade secrets and
commercial or financial information that is privileged or confidential
(see 21 CFR 20.61).

S. Consequences of Failure to Comply (Sec.  1.1460)

    We proposed to codify in subpart S certain FSMA provisions related
to the consequences of failing to comply with these traceability
recordkeeping requirements. Section 204(j)(1) of FSMA

amends section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to make it a
prohibited act to violate any recordkeeping requirement under section
204 of FSMA (except when such violation is committed by a farm). We
therefore proposed, in Sec.  1.1460(a), to specify that the violation
of any recordkeeping requirement under section 204 of FSMA, including
the violation of any requirement of subpart S, is prohibited under
section 301(e) of the FD&C Act, except when such violation is committed
by a farm.
    Section 204(j)(2) of FSMA amended section 801(a) of the FD&C Act
(21 U.S.C. 381(a)) by adding paragraph (a)(4), which states that FDA
shall refuse admission to an article of food if it appears from
examination of samples of the food or otherwise that the recordkeeping
requirements under section 204 of FSMA (other than the requirements
under section 204(f), which concern FDA requests for information from
farms under certain circumstances, and which are not addressed in this
rulemaking) have not been complied with regarding such article. We
therefore proposed, in Sec.  1.1460(b), to specify that an article of
food is subject to refusal of admission under section 801(a)(4) of the
FD&C Act if it appears that the recordkeeping requirements under
section 204 of FSMA (other than the requirements under section 204(f)),
including the requirements of subpart S, have not been complied with
regarding such article.
    Although we are finalizing these provisions as proposed, in the
following paragraphs we respond to comments regarding actions FDA might
take in response to the commission of prohibited acts under Sec.
1.1460(a) and comments on implementation of the refusal of admission
provision in Sec.  1.1460(b).
1. FDA Response To Commission of a Prohibited Act
    (Comment 482) Several comments ask that we specify the types of
consequences that could result from failing to comply with the FTL
traceability requirements. One comment asks whether we will follow a
tiered approach to imposing consequences that progresses from issuing a
warning letter, to levying a fine, to issuing a stop sale order. One
comment recommends that we levy fines for producers that do not comply
with the regulation. One comment requests clarification regarding the
consequences of non-compliance by RFEs. One comment asks whether a
State agency with an established produce safety program may determine
the consequences for farms that fail to comply with subpart S.
    (Response 482) Under Sec.  1.1460(a) of the final rule, the
violation of any recordkeeping requirement under section 204 of FSMA or
subpart S (except when such violation is committed by a farm) is a
prohibited act under section 301(e) of the FD&C Act. While we intend to
work to educate industry before and while we regulate to assist
industry in understanding and coming into compliance with the subpart S
requirements, there are various actions the Federal government may take
if an entity commits a prohibited act under section 301(e) of the FD&C
Act. Depending on the nature of the violation, it is generally FDA's
practice to give individuals and firms an opportunity to take prompt
and voluntary corrective action before we initiate an enforcement
action. We may issue advisory action letters, which include Untitled
and Warning Letters, to notify firms of violations and to prompt
voluntary compliance. When voluntary compliance is not forthcoming, the
Federal government may bring a civil action in Federal court to enjoin
persons who commit a prohibited act. The Federal government may also
bring a criminal action in Federal court to prosecute persons who
commit a prohibited act. (FDA does not have the authority to impose
fines for violations of section 204 of FSMA or subpart S.) As
appropriate, FDA may hold multiple entities responsible for the failure
to maintain traceability records in accordance with subpart S.
    As discussed in Section V.U of this document, we are in the process
of developing our compliance strategy for the traceability rule. We
plan to work with our State, Local, Tribal, and Territorial (SLTT) and
other regulatory partners to implement efficient enforcement of the
rule, including coordinating actions or deferring to each other when a
particular agency is best situated to act swiftly to protect consumers.
We are still determining how we will work with our SLTT and other
regulatory partners in the implementation and enforcement of the rule.
2. Refusal of Admission
    (Comment 483) One comment expresses support for proposed Sec.
1.1460(b) and asserts that any seafood offered for importation by an
importer that cannot meet the traceability requirements of proposed
Sec.  1.1330(a)(2) (which were the proposed first receiver requirements
relating to the harvesting of a food) should not be allowed entry into
the United States. The comment maintains that there have been many
instances in which a foreign shrimp exporter has been incapable of
identifying the source of shrimp packaged for export, and the comment
contends that FDA has identified this inability to trace imported
seafood back to its source as a significant threat to the health of
U.S. consumers. In contrast, one comment maintains that there seem to
be harsher penalties for foreign entities than domestic entities that
fail to comply with the rule, including the fact that imported food may
be refused entry under proposed Sec.  1.1460(b). The comment asks that
FDA be mindful of its obligations under the World Trade Organization
(WTO) to ensure that foreign entities are not held to different
standards than those applicable to domestic firms.
    (Response 483) As previously stated, Sec.  1.1460(b) incorporates
into subpart S section 801(a)(4) of the FD&C Act, which states that FDA
shall refuse admission to an article of food if it appears from
examination of samples of the food or otherwise that the recordkeeping
requirements under section 204 of FSMA (other than the requirements
under section 204(f)) have not been complied with regarding such
article. The ability to refuse admission to a food under section
801(a)(4) of the FD&C Act is one of the tools Congress gave FDA to help
ensure compliance with subpart S. Other tools available to FDA include
those related to the prohibited act in section 301(e) of the FD&C Act
(as referenced in Sec.  1.1460(a)), as discussed in Response 482. As
discussed in Section V.U.3 of this document, we believe the final rule
is consistent with U.S. international trade obligations, including
those under the WTO, because the same traceability recordkeeping
requirements that apply to foreign entities also apply to domestic
entities.
    (Comment 484) One comment urges us not to require importers to
ensure their supply chains are fully compliant with the rule as a
condition of importation of their food. The comment asks whether we
intend to check traceability records or conduct tracebacks as a
condition of importation of their food.
    (Response 484) Importers that do not physically possess food on the
FTL are not subject to subpart S requirements. The final rule does not
require importers of FTL foods to verify that entities in their supply
chain are in compliance with the subpart S requirements as a condition
of importation. However, importers may wish to be aware of whether
their suppliers are subject to, and in

compliance with, subpart S requirements because under section 801(a)(4)
of the FD&C Act, an article of food is subject to refusal of admission
if it appears that the requirements under subpart S have not been met
for that food (see Sec.  1.1460(b)). We are still determining our
approach to enforcement of the subpart S requirements and the
appropriate circumstances regarding refusal of admission for non-
compliance with the rule.
    (Comment 485) One comment expresses concern that an overly wide
range of foods may become subject to a refusal of admission under
proposed Sec.  1.1460(b). The comment maintains that if a problem is
detected in only one of many factories within the same company, it
would not be reasonable to automatically reject all the foods from that
company.
    (Response 485) The refusal of admission authority in section
801(a)(4) of the FD&C Act (which is referenced in Sec.  1.1460(b))
applies to apparent non-compliance with the recordkeeping requirements
under section 204 of FSMA (including subpart S), not any other FDA
regulations. We agree that in general it would not be appropriate to
deny admission to all foods from a company when a single factory
associated with that company fails to meet applicable subpart S
requirements for one or more FTL foods, particularly if the company
works to address the noncompliance in a timely manner. Under section
801(a)(4) of the FD&C Act, an article of food is subject to refusal of
admission if it appears--either from examination of the food or
otherwise--that the subpart S requirements have not been complied with.
If a company has a history of non-compliance with subpart S at one or
more of its locations, including a failure to come into compliance
after subpart S violations were brought to the company's attention, we
would consider this history in deciding whether to refuse admission to
some or all of the company's FTL foods.
    (Comment 486) Some comments ask that we revise proposed Sec.
1.1460(b) to provide a means for a foreign supplier's shipment to gain
entry following an admission refusal. The comments suggest that
importers could remedy a violation by verifying corrective actions
taken by a foreign supplier.
    (Response 486) We decline to codify a procedure for requesting
termination of a refusal of admission under Sec.  1.1460(b). To the
extent that the comment is asking about procedures for removal of food
from detention without physical examination (DWPE) under an import
alert due to non-compliance with the subpart S recordkeeping
requirements, existing procedures are likely to be applicable. An
article of food may be subject to refusal and the food and covered
entity placed on DWPE because information indicates the appearance of a
violation of an applicable FDA regulation (such as subpart S). Our
decision to remove a food and covered entity from an import alert is
based on evidence establishing that the conditions that gave rise to
the appearance of a violation have been resolved and we have confidence
that future entries will be in compliance with the relevant
requirements. FDA import alerts often provide information about
obtaining removal from the import alert, in particular how to submit
information that resolves the appearance of a violation. If we place
any food and covered entity that failed to comply with subpart S on
import alert, we plan to provide information in the import alert about
removal from the alert. Depending on the nature of the violations at
issue, we might specify that we will review traceability records from
the covered entity responsible for the violation(s) of subpart S before
granting removal. However, such a review might not always be necessary.
    (Comment 487) One comment requests that we create a unique
violation code for food entry lines refused at the border in accordance
with proposed Sec.  1.1460(b). The comment also asks that we establish
a unique charge code to facilitate the public's ability to monitor our
enforcement of the new traceability requirements as applicable to
imported foods.
    (Response 487) As stated in Section V.U.4 of this document, we are
developing our compliance and enforcement strategy for entities that
fail to comply with subpart S. It is likely that we will establish a
new charge code in FDA's import system for processing entries to
identify food that is refused entry in accordance with section
801(a)(4) of the FD&C Act and Sec.  1.1460(b). The publication of an
import alert relating to violations of subpart S would then include
this charge code, along with a description of the applicable laws and
regulations. We currently publish an Import Refusal Report (IRR) on
those products for which we determined to refuse admission, including
the charge information that identifies the reason for Agency actions.

T. Updating the FTL (Sec.  1.1465)

    In accordance with section 204(d)(2)(B) of FSMA, we proposed in
Sec.  1.1465 to establish procedures for updating the FTL to designate
new foods on the list and remove foods from the list when appropriate.
We received several comments on the proposed requirements for updating
the FTL, to which we respond in the following paragraphs.
1. Procedure for Updating the FTL
    We proposed in Sec.  1.1465(a) that when we tentatively conclude,
in accordance with section 204(d)(2) of FSMA, that it is appropriate to
revise the FTL, we will publish a notice in the Federal Register
stating the proposed changes to the list and the reasons for those
changes and requesting public input on the proposed changes. We
proposed in Sec.  1.1465(b) that after considering any information and
views submitted on the proposed changes to the FTL, we will publish a
notice in the Federal Register stating whether we are making any
changes to the list and the reasons for the decision. We also proposed
that if we revise the FTL, we will publish the revised list on our
website. We are finalizing these procedures in Sec.  1.1465 as
proposed.
    (Comment 488) Many comments suggest that updating the FTL should
take place on a scheduled timetable to ensure that FDA takes into
account changes in product safety, food safety improvements, current
risk of foods, and consumer dietary changes, and to ensure that the FTL
reflects the most recent science and knowledge from outbreaks. The
comments also maintain that updating the FTL on a regular schedule
would provide predictability to the food industry to prepare for
potential changes to the FTL. The comments suggest a range of possible
timeframes for updating the FTL, from quarterly to every 5 years.
    (Response 488) As part of our administration of the FTL, we will
periodically review data and other information relevant to the seven
criteria for commodity-hazard pairs in the RRM-FT, including the
consideration of food safety improvements across commodities. We will
also determine whether we should add new or revised commodity-hazard
pairs to the Model. We agree with the comments that we should update
the FTL on a consistent basis. Therefore, we have determined that we
intend to update the FTL approximately every 5 years, subject to
available resources. We conclude that this 5-year timeframe would allow
for the time needed to update the RRM-FT with new data and information,
develop a proposed revised FTL and accompanying materials, publish a
notice in the Federal Register stating the proposed changes to the FTL
and the reasons for these changes,

review comments from the public on the proposal, and publish a second
notice in the Federal Register stating whether we are making any
changes to the FTL and the reasons for the decision, as set forth in
Sec.  1.1465. As part of this process and before proposing any changes
to the FTL, we intend to provide stakeholders with a mechanism to
submit relevant data for our consideration as part of our update to the
RRM-FT.
    For the initial update to the FTL following the publication of the
final rule, we will take into consideration the compliance date for the
final rule when deciding when to begin the process outlined above.
    We agree with the comments that adopting a regular schedule for
updating the FTL will provide consistency and help stakeholders be
aware of any possible changes to the FTL. However, if substantial new
data or information critical to public health emerges, we may decide to
review the RRM-FT and the FTL more frequently than every 5 years. An
example of such information might be the occurrence of multiple
unrelated foodborne illness outbreaks involving a food not on the FTL
within the same year. Conversely, we may also update the RRM-FT with
new data and information and determine that no changes are needed to
the FTL. In that case, we will inform the public that the RRM-FT was
updated and the FTL has not changed.
    (Comment 489) Many comments request that we update the FTL through
notice and comment rulemaking. Some comments assert that the APA
requires that the FTL be updated through rulemaking because the FTL
defines the scope of the rule, has substantive effects on industry, and
acts as a regulation.
    (Response 489) Congress explicitly spoke to the process for
updating the FTL, and Sec.  1.1465 is in keeping with what Congress
provided. Section 204(d)(2)(B) of FSMA states that FDA may update the
FTL to designate new foods and to remove foods that are no longer
deemed necessary for inclusion, provided that each such update to the
list is consistent with the requirements of section 204(d) and notice
of the update is published in the Federal Register. Section 1.1465 of
the final rule incorporates into subpart S the requirement to provide
notice of an update of the FTL in the Federal Register. In accordance
with Sec.  1.1465(a) and (b), when we tentatively conclude that it is
appropriate to revise the FTL, we will publish a notice in the Federal
Register stating the proposed changes and the reasons for those changes
and requesting public input, after which we will review comments from
the public and publish a second notice in the Federal Register stating
whether we are making any changes to the FTL and the reasons for the
decision. We conclude that this process is in keeping with section
204(d)(2)(B) of FSMA and will give stakeholders sufficient opportunity
to provide input on any potential changes to the FTL.
    (Comment 490) Several comments request that stakeholders be able to
provide input into the development of the FTL. Some comments express
interest in engaging with FDA to ensure the most recent data is
available in developing the FTL. Many comments request that we develop
a process by which stakeholders can request that a food be removed from
or added to the FTL. One comment asks that we update the FTL upon a
request from stakeholders, including industry, regulators, or public
health officials.
    (Response 490) As described in Section V.B of this document, we
solicited and considered public input into the development of the RRM-
FT, which provides the basis for identifying the foods included on the
FTL. As discussed in Response 488, we intend to update the FTL
approximately every 5 years, subject to available resources. This
process will include updating the RRM-FT with new data and information,
developing a proposed revised FTL and accompanying materials, and, if
we tentatively conclude that it is appropriate to revise the FTL,
following the procedures set forth in Sec.  1.1465. As part of this
process and before proposing any changes to the FTL, we intend to
provide stakeholders with a mechanism to submit relevant data for our
consideration as part of our update to the RRM-FT. When updating the
RRM-FT, we will use the most recent data available, depending on
availability of data sources.
    We decline to create a process for stakeholders to request that we
update the FTL. We believe that the approach of updating the FTL
approximately every 5 years, subject to available resources, is more
appropriate considering the time and resources that are needed for this
process. We believe that the process set forth in Sec.  1.1465 will
provide stakeholders sufficient opportunity to provide input on any
changes to the FTL. If we were to set up a process for stakeholders to
request updates to the FTL, it would introduce uncertainty about the
frequency of updates and potentially necessitate the use of significant
resources. To the extent that the comments are suggesting a process
under which individual foods would be evaluated for addition to, or
removal from, the FTL, we note that when updating the RRM-FT, we want
to consistently apply new data and information across all commodities,
rather than conducting analyses of individual foods, to help ensure the
integrity of the RRM-FT and our analysis.
    (Comment 491) One comment recommends that we convene expert panels
with representation from the food industry to advise the Agency on
updating the FTL.
    (Response 491) At present we do not intend to convene expert panels
to help update the FTL. We intend to update the FTL approximately every
5 years, subject to available resources, following the process
described in Response 488. As part of that process and before proposing
any changes to the FTL, we intend to provide stakeholders with a
mechanism to submit relevant data for our consideration as part of our
update to the RRM-FT. We believe that this opportunity to submit
relevant data, combined with the opportunity to submit comment on
proposed changes to the FTL as described in Sec.  1.1465(a), will
provide all stakeholders, including different parts of the food
industry, sufficient opportunity to provide input.
    (Comment 492) A few comments request that we develop a system for
farmers to know which foods are under consideration for being added to
the FTL. The comments maintain that this would allow farmers to factor
in this information when making planting decisions.
    (Response 492) As previously stated, we intend to update the FTL
approximately every 5 years, subject to available resources. This
should enable stakeholders, including farmers, to become aware of any
new foods under consideration for being added to the FTL. Further,
Sec.  1.1465(c) (discussed below) specifies that any additions to the
FTL will become effective 2 years after the date of publication of the
Federal Register notice announcing the revised list, unless otherwise
stated in the notice. We believe this is sufficient time for entities
to ensure they are ready to comply with the rule for any new foods on
the FTL.
    (Comment 493) Several comments ask that we release to the public
the risk scores for commodity-hazard pairs and data used in the Model
for each food that is added to or removed from the FTL when it is
updated in the future.
    (Response 493) When we update the FTL, we will publish a notice in
the Federal Register stating whether we are making any changes to the
list and the reasons for the decision, in accordance with Sec.
1.1465(b). We also intend to make available the commodity and

commodity-hazard pair risk scores and additional information to provide
the public with a clear understanding of why certain foods are on the
FTL.
    (Comment 494) Many comments ask that we clarify how foods can be
added to and removed from the FTL, as well as the factors we will
consider when reanalyzing the FTL and the scientific basis to support
updates to the FTL.
    (Response 494) As discussed in Response 5, to determine which foods
should be included on the FTL, we developed a risk-ranking model for
food tracing based on the factors that Congress identified in section
204(d)(2)(A) of FSMA. To determine whether any foods should be added to
or removed from the FTL, we intend to use the same approach we used
when developing the initial FTL for the proposed rule. This includes
use of the same factors specified in section 204(d)(2)(A) of FSMA as
operationalized in the RRM-FT. We will update the RRM-FT with new data
and information based on the criteria and approach outlined in the
Methodological Approach Report.
    In the future, as additional data streams, risk assessment methods,
and computational methods arise, we may decide to modify how we
implement the factors in section 204(d)(2)(A) of FSMA into a risk-
ranking model. However, we do not anticipate developing a new model
every 5 years.
    (Comment 495) Some comments ask that we exercise enforcement
discretion for a food that we have proposed to remove from the FTL for
the period of time that the proposal is pending notice and comment. The
comments assert that unless we are seeking records for such a food to
address a threat to the public health under proposed Sec.
1.1455(b)(3), we should not enforce the recordkeeping requirements
because the proposal to remove the food demonstrates that we no longer
consider it to pose a high risk.
    (Response 495) We do not intend to exercise enforcement discretion
as suggested, although we may consider the status of these foods as we
prioritize limited inspection resources. In accordance with Sec.
1.1465(a), when we tentatively conclude that it is appropriate to
remove a food from the FTL, we will publish a notice in the Federal
Register stating the proposed removal and the reasons for the change,
and requesting information and views on the removal. Submitted comments
may provide data or information that could change our mind about
removing the food from the FTL. Any deletions from the FTL would become
effective as soon as FDA updates the FTL, which would happen only after
we had considered any information and views submitted on the proposed
removal, and after we had published a notice in the Federal Register
stating our decision to remove the food from the list (see Sec.
1.1465(b) and (c)).
    (Comment 496) A few comments urge us to ensure the FTL is updated
based on the most recent available data. One comment asks how we will
address data gaps in updating the Model and the FTL.
    (Response 496) When updating the RRM-FT, we will use the most
recent data available, depending on availability of data sources. For
example, while we will use the most recent version of NHANES data
available, those data reflect events from a few years before the public
availability of the data based on how NHANES releases their data. As
described in the Methodological Approach Report (Ref. 10), we scored
the seven criteria in the Model based on available data, both
quantitative and qualitative. If quantitative data was not available
for a certain criterion, the criterion was scored based on qualitative
data, which sometimes included expert elicitations. We plan to take a
similar approach in the future.
    (Comment 497) A few comments maintain that as food safety
technologies improve and adoption of them increases, and if risks
decrease, we should seek to decrease the number of foods on the FTL.
    (Response 507) As discussed in Response 498, we will periodically
review data and other information relevant to the seven criteria for
commodity-hazard pairs in the RRM-FT. This could include the
consideration of food safety improvements across commodities and
information on any new technologies that may affect food safety for
specific commodities or industries. Updating the Model might result in
foods coming off the FTL, but that would depend on any changes we might
make to the Model as well as the risk scores of the foods based on the
data in the Model.
2. Timeframe for Implementation of FTL Changes
    We proposed in Sec.  1.1465(c) that when FDA updates the FTL, any
deletions from the list will become effective immediately, while any
additions to the list will become effective 1 year after the date of
publication of the Federal Register notice announcing the revised list,
unless otherwise stated in the notice.
    (Comment 498) Many comments request that when a food is added to
the FTL, entities be given 2 years, rather than just 1 year, before
firms that manufacture, process, pack, or hold this food must be in
compliance with the rule. The comments maintain that 2 years are needed
to allow entities handling foods added to the FTL sufficient time to
update their recordkeeping practices and make any relevant changes to
their supply chains. The comments also maintain that supply chains for
new foods added to the FTL will need the same transition time as the
supply chains associated with foods on the first iteration of the FTL.
Some comments maintain that some products may have a shelf life of more
than 12 months, so that it would take longer than 1 year to go through
any old product inventory in the supply chain.
    (Response 498) We agree that more than 1 year may be needed for
firms to revise or update their traceability operations when new foods
are added to the FTL, and we believe that 2 years will generally
provide sufficient time in which to take these actions and come into
compliance with the rule with respect to the added foods. Therefore, we
have revised Sec.  1.1465(c) to specify that any additions to the FTL
will become effective 2 years after the date of publication of the
Federal Register notice announcing the revised list, unless otherwise
stated in the notice. Section 1.1465(c) further states that any
deletions from the FTL will become effective as soon as FDA updates the
FTL.
    Although we do not anticipate that it would occur frequently, there
may be situations in which we decide that the 2-year timeframe for the
effective date of additions to the FTL should not apply. For example,
in the case of an urgent public health concern related to a particular
food that is added to the FTL, we might determine it is necessary to
require firms handling that food to maintain and provide subpart S
records sooner than 2 years. Conversely, if coming into compliance with
subpart S within 2 years may be especially challenging for firms
handling a particular food, we may determine that more time is needed
for that industry to come into compliance. Any differences in the
effective date from the standard 2-year timeframe would be stated
specifically in the Federal Register notice announcing the revised FTL.
    We do not intend to conduct our first update to the FTL until after
the initial compliance date for the final rule. This will allow
industries with foods currently on the FTL to work towards compliance
without concern about changes to the FTL before implementation. We
describe our

process for updating the FTL in Response 488.
    We recognize that the final rule provides 3 years from the rule's
effective date for firms to come into compliance, as discussed in
Section VI of this document. We have concluded that it is appropriate
for this initial compliance period to be longer than the 2 years we are
providing in Sec.  1.1465(c) for additions to the FTL to become
effective. Many of the traceability systems that will be
operationalized in advance of the first compliance date will be in
place when the FTL is updated. Therefore, we have determined that 2
years for any new additions to the FTL will be sufficient.
    (Comment 499) One comment raises concerns about the impact of
changes to the FTL on small farmers, which the comment asserts have
less time and fewer resources than larger entities to come into
compliance with the rule.
    (Response 499) We agree that some small farms might have fewer
resources for traceability recordkeeping than some larger entities,
although they also might handle fewer FTL foods than larger firms. As
previously discussed, the final rule exempts some small farms from
subpart S and adopts other exemptions that might apply to some smaller
farms or certain FTL foods from these farms. As stated in Response 498,
when we update the FTL, any additions to the list will not become
effective until 2 years after we publish the revised list, so any
smaller farms that are subject to the rule would have 2 years to
prepare for compliance with subpart S with respect to the foods that
have been added to the FTL. We believe this will provide sufficient
time even for smaller entities to come into compliance with the rule
regarding the FTL foods they handle.

U. Other Issues

    We received comments on several other matters related to the rule,
including traceability technology and standards, international trade
concerns, outreach and training, and implementation and enforcement of
the rule. We respond to the comments in the following paragraphs.
1. Traceability Technology and Standards
    (Comment 500) Some comments maintain that entities would have to
update their traceability systems to maintain and share the required
KDEs. The comments further assert that this would have a financial
impact on entities shipping FTL foods, as they will have to invest in
technology to produce information whose format might not be compatible
with that used by their customers. One comment asserts that this need
to purchase technology would have an impact across the entire food
industry but would especially affect small businesses, contrary to the
directive in section 204(d)(1)(E) of FSMA that the traceability
recordkeeping requirements be scale-appropriate and practicable for
facilities of varying sizes and capabilities. One comment asserts that
examples of sending tracing information to customers provided in the
preamble to the proposed rule and at public meetings assume use of
technology that may not be widely adopted in the seafood industry. One
comment maintains that the proposed rule would force many companies to
move to EDI ASNs, which the comment contends would be expensive to set
up, validate, and maintain for businesses with thousands of suppliers.
The comments ask that we modify the proposed rule to allow firms to
comply with limited or no access to such technology.
    (Response 500) The final rule does not require covered entities to
adopt new technologies to meet their subpart S requirements. While we
recognize that some firms may want to invest in certain technological
tools or systems, not all firms want to or are financially able to do
so. Therefore, the final rule provides firms with considerable
flexibility in how they can meet their requirements, including the
ability to keep records in paper or electronic form and to use existing
records to the extent that they contain required information (see Sec.
1.1455(a) and (f)). We recognize that covered entities vary widely in
their traceability procedures and practices, and that coming into
compliance with subpart S might have a greater financial impact on
certain entities, especially smaller ones. Consequently, the final rule
fully exempts certain smaller entities from subpart S and exempts
others from the requirement to provide an electronic sortable
spreadsheet containing requested traceability information in certain
circumstances.
    (Comment 501) Several comments suggest that traceability will be
improved by the use of digitization and electronic records. One comment
maintains that technologies can help address issues raised by farmers
and food processors, including by easing the burden for small farms,
reducing the burden of duplicative recordkeeping requirements by
different regulatory bodies, and protecting against unnecessary
exposure of trade secrets. One comment contends that the use of
electronic records for traceability could reduce the scope of recalls
and result in improved consumer confidence in producers. One comment
asserts that the continued use of paper records may hinder information
sharing or compromise accuracy during outbreak investigations. Some
comments ask that the rule require electronic recordkeeping for
traceability to facilitate sharing of data and information, while other
comments assert that use of electronic records should be voluntary.
Several comments ask that we encourage the use of electronic
recordkeeping. On the other hand, some comments support the fact that
all-digital systems are not required, and some assert that it will take
years for some entities, even some larger ones, to adopt electronic
recordkeeping.
    (Response 501) As stated in the preamble to the proposed rule (85
FR 59984 at 60017), although we strongly encourage all entities in the
supply chain to adopt electronic recordkeeping for traceability, we
recognize that not all firms have systems in place to maintain and
provide information in electronic form, and that adopting such systems
to meet subpart S requirements could be burdensome for some firms.
Therefore, the rule allows persons subject to subpart S to keep
required records in either paper or electronic form (see Sec.
1.1455(a)). Under FDA's New Era of Smarter Food Safety initiative, we
will continue to explore ways to encourage entities to voluntarily
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 New Era of Smarter
Food Safety Blueprint (Ref. 18).
    (Comment 502) One comment expresses concern that the proposed rule
will be challenging for companies that rely on paper records,
particularly small companies, due to the volume and type of KDEs
required. The comment maintains that their direct suppliers can meet
some of the proposed requirements but they may be challenged in
collecting and passing along their suppliers' information due to the
digitization effort required, particularly with respect to bulk
ingredients received from distributors. The comment states that
coordination by the industry is required to achieve the goal of rapid
traceability under the rule.
    (Response 502) As previously stated, firms are not required to keep
their records in electronic form or to digitize records they received
in paper form. However, we recognize that firms that maintain records
electronically may incur costs in digitizing information they receive
in paper records, and that

procedures to identify and document FTL ingredients, regardless of
whether or not they are in bulk form, might involve coordination with
suppliers. We encourage coordination and communication by industry to
ensure supply chain traceability for FTL foods and for entities to work
with their supply chain partners to send and receive records to meet
the requirements of subpart S. One option for coordinating and
communicating the required traceability information to be shared
between firms would be through contractual agreements often associated
with commercial POs. By using options such as this, firms can clarify
the KDEs that must be provided.
    (Comment 503) One comment asks that we address what systems firms
should use to receive, store, and access digital traceability records.
The comment also requests that we clarify how we will receive records
from small businesses, including how we will secure the data and
mitigate company privacy concerns.
    (Response 503) As previously stated, the rule does not prescribe
specific technologies for records maintenance or communication with
subsequent recipients or the Agency. For those firms wishing to keep
subpart S records in electronic form, there are several systems and
technologies they might consider using to help them meet their
requirements under the rule. We will review firms' subpart S records
when they are made available upon the request of an authorized FDA
representative in accordance with Sec.  1.1455(c) of the final rule. We
intend to develop materials addressing how firms can provide records
and electronic sortable spreadsheets to us. As discussed in Section V.R
of this document, in response to concerns about maintaining the
confidentiality of traceability information provided to FDA, we are
adding a provision (Sec.  1.1455(h)) specifying that records we obtain
in accordance with subpart S are subject to the disclosure requirements
in part 20 of FDA's regulations, which include provisions concerning
the non-disclosure of trade secrets and commercial or financial
information that is privileged or confidential.
    (Comment 504) One comment maintains that the proposed rule does not
discuss the importance of data sharing among supply chain partners and
focuses too narrowly on data collection between the covered entity and
FDA. The comment asserts that sharing data and records is most widely
and commonly facilitated using digital data-sharing standards such as
GS1's GDSN for product information (Trade Item Data), EDI for
transactional data, and GS1's EPCIS for physical event data. The
comment asks FDA to highlight widely used marketplace standards for
digital data sharing, such as GDSN, EDI, and EPCIS, in any FDA guidance
that may accompany the final rule.
    (Response 504) We disagree that the rule does not acknowledge the
importance of data sharing among supply chain partners. In fact, we
recognize that such information sharing is vital to ensuring effective
and efficient traceability. It is for this reason that the framework of
the rule includes requirements outlining the specific KDEs for the
different CTEs in the supply chain, and specifying which KDEs must be
provided to an entity's supply chain partners (for example, by shippers
to receivers). As previously stated, although we encourage firms to use
available technologies to facilitate their sharing of information with
supply chain partners, the rule does not require the use of electronic
records and does not prescribe any specific technologies for records
maintenance or sharing. Therefore, firms may use any system or
standards that help them meet their requirements to keep and provide
information under subpart S. We might consider addressing how firms
might use existing systems and standards to meet subpart S requirements
in future guidance for industry.
    (Comment 505) Some comments recommend that the rule address the use
of product barcodes as a traceability tool. One comment suggests that
we select a barcode type such as GS1-128 that would allow for
distribution hubs and other locations to apply for numbers. Some
comments request recognition that their implemented system for lot-
level tracking using a GS1-128 barcode applied to the shipping
container would meet the subpart S requirements. One comment asserts
that firms are using different barcodes and different dating systems,
and contends that there must be some type of standard for the
traceability rule to be effective. One comment states that the proposed
rule does not address the importance of capturing product identities
physically on food products for robust food traceability in conjunction
with sharing traceability data. The comment maintains that automatic
identification and data capture (AIDC) tools, such as barcodes and
radio-frequency identification (RFID) tags, which capture food product
identities and other pertinent data affixed to the physical object,
play a vital role in ensuring congruence between traceability data
exchanged and events in food supply chains, and asks FDA to recognize
AIDC standards and encourage the use of AIDC tools in any guidance
accompanying the final rule.
    (Response 505) While we recognize the utility of product barcodes
and that having industry adopt standards for their use could enhance
traceability, section 204(d)(1)(C) of FSMA prohibits us from
prescribing specific technologies for the maintenance of records, while
section 204(d)(1)(G) specifies that, to the extent practicable, the
regulations must not require a facility to change business systems to
comply with the requirements. Because the food industry has already
developed and adopted the use of various data carriers, if we were to
require use of a specific data carrier for any of the KDEs passed from
shipper to receiver, a significant number of firms would have to
replace their current systems (including firms that currently use
paper-based systems). Moreover, if we were to require the use of a
specific data carrier or to structure the rule around a specific
carrier or type of technology, we would run the risk of having the rule
become outdated as new technologies are developed. We have therefore
opted to allow for significant flexibility in how firms choose to
comply with the rule. We will consider the usefulness of issuing
materials that address the use of existing technologies, including
product barcodes, for the maintenance and sharing of traceability
information.
    (Comment 506) One comment asks that we recognize the utility of
serial shipping container codes (SSCC) to complement batch/lot level
tracing of food products and include the SSCC in any guidance
accompanying the final rule. The comment maintains that use of an SSCC
aids in tracing the path of a food product in a traceback situation,
working in conjunction with batch/lot level identification and without
necessitating item-level serialization.
    (Response 516) 506) We recognize that the use of SSCCs can be a
helpful tool for improving traceability, and firms may wish to use them
together with the required traceability lot codes. While SSCCs are not
required under subpart S, we encourage the use of any tools that will
improve a firm's procedures for traceability and support the
maintenance and sharing of the required traceability records under the
final rule.
    (Comment 507) Several comments ask that we consider requiring the
use of globally unique product identifiers (e.g., GS1 GTIN, GS1 GLN,
unique resource locators (URL), universal unique identifiers (UUID)),
assigned according to recognized industry standards (e.g.,

GS1, American National Standards Institute (ANSI), International
Organization for Standards (ISO)), encoded into machine-readable data
carriers (e.g., 1D and 2D barcodes, RFID, or internet-of-things devices
(IoT)) and attached to traceable objects, to facilitate electronic
capture of globally unique traceability lot codes and associated KDEs.
    (Response 507) We recognize that the use of globally unique product
identifiers can be a helpful tool for improving traceability, and firms
may wish to use them in establishing required traceability lot codes,
including by encoding and attaching them as described in the comments.
However, we are not making this a requirement under the final rule. We
recognize that while some firms and systems may use these specific
standards, not all firms and systems maintain and provide information
in this way, and we want to allow sufficient flexibility for firms to
maintain and provide the required KDEs based on their preferred
systems. Therefore, the rule does not require traceability lot codes to
be globally unique, nor does it require them to be encoded into
machine-readable data carriers and attached to traceable objects. We
believe that the traceability lot code for an FTL food combined with
the product description and other required KDEs should be sufficiently
unique for our traceability purposes during an outbreak investigation,
and we believe there are a variety of ways that firms can provide the
required KDEs to their supply chain partners.
    (Comment 508) One comment recommends that we require the use of
case-level GTINs to identify the originator or brand owner of the food.
Another comment suggests that the primary information needed for
traceability is the lot number of the food, the identification of the
product such as the GTIN, and contact information for the entity that
assigned the lot number. The comment asserts that additional
descriptors about the food are unnecessary if a GTIN is available.
    (Response 508) We recognize that GTINs can be a helpful tool for
improving traceability, and firms may wish to use them as part of their
traceability systems. However, we do not think it is appropriate to
require their use. As discussed above, we have designed the rule to be
flexible so that firms may use a range of methods or standards to
comply.
    As discussed in Section V.C of this document, we believe that the
KDEs we are requiring in the final rule are all necessary to ensure
efficient and effective traceability of FTL foods. Regarding the
comment that additional descriptors about the food are unnecessary if a
GTIN is available, we recognize that some of the required KDEs, such as
elements of the product description that may be contained within the
GTIN trade item identification, may be linked to a GTIN in a database.
When this is the case, firms would not need to maintain that
information separately, provided they meet the requirements of the rule
relating to those data elements (e.g., by maintaining the information
for 2 years in accordance with Sec.  1.1455(d); and by providing the
product description, as defined, to FDA upon request in accordance with
Sec.  1.1455(c), and to immediate subsequent recipients in accordance
with Sec.  1.1340(b)).
    (Comment 509) One comment requests that the final rule focus on
permissioned access to data throughout the supply chain using data
standards such as GS1 Digital Link and ISO/IEC 20248:2018 Digital
Signature Meta Data Structure, together with AIDC.
    (Response 509) The final rule permits (but does not require) the
use of permissioned access to data, for example in the context of
shippers providing required KDEs to receivers under Sec.  1.1340(b). As
discussed above, we have designed the rule to be flexible so that firms
may use a range of methods or standards to comply.
    As discussed in Response 412, the final rule establishes the
concept of the traceability lot code source reference, which is an
alternative method through which information on the traceability lot
code source could be made available to FDA while protecting the
confidentiality of that information. Various methods for offering
permissioned access to data, such as those described in the comments,
could be used in this context. For example, a shipper of an FTL food
may choose to use a web address in a QR code or a GS1 Digital Link as a
traceability lot code source reference that they provide to the
recipient of the food. Such a web address may employ reasonable
security measures, such as only being accessible to a government email
address, provided the Agency has access to the information at no cost
and without delay.
    (Comment 510) One comment suggests that FDA work with producers to
create a software program that would allow them to track and share
traceability data. The comment suggests that the software could be in
Excel or a unique software program.
    (Response 510) We intend to develop materials with examples on how
firms can maintain and share with supply chain entities information
required under subpart S. As part of FDA's New Era of Smarter Food
Safety initiative, we sponsored a Low- or No-Cost Tech-Enabled
Traceability Challenge (Ref. 30) to encourage the development of low-
to no-cost traceability solutions to help enable food operations of all
sizes to participate in traceability efforts in a scalable, cost-
effective way. However, at present we do not plan to develop a software
program for use by persons subject to the rule.
    (Comment 511) Some comments request that we establish a single
digital system or de-centralized database such as blockchain for
storage of traceability information to simplify implementation, help
producers obtain initial licensing rights, speed investigations and
recalls, provide data uniformity, reduce manual data entry, and support
the adoption of 2D QR codes linked to KDEs and CTEs to ease data
communication. One comment asserts that lack of a single system for
transaction data storage creating seamless electronic interoperability
among many disparate and highly competitive entities has been a
significant challenge for implementation of drug product tracing under
the Drug Supply Chain Security Act (DSCSA) and would present a similar
challenge for food traceability. On the other hand, one comment
maintains that a single method for collecting all food supply chain
data or a single repository for holding and sharing such information is
neither feasible nor desirable.
    (Response 511) We do not believe it is necessary or appropriate to
establish a single system or database to achieve the rule's purpose of
facilitating traceability of FTL foods. Participating in such a system
or database could be costly or otherwise infeasible for some covered
entities because it would require electronic recordkeeping, and
mandating participation in such a system or database may be
inconsistent with section 204(d)(1)(C) and (E) of FSMA. We believe that
the rule can achieve its intended goal of improving the traceability of
FTL foods without requiring participation in a single electronic
records system or database.
    (Comment 512) One comment asserts that although the proposed rule
defines discrete CTEs, it does not require companies to indicate the
CTEs in data submissions to FDA, which the comment maintains could be a
critical aid for interpreting the data quickly. The comment asserts
that EPCIS includes classifications of events to help

users and software tools quickly interpret the structure of data
contained within the event.
    (Response 512) The rule requires covered persons to keep KDEs for
particular CTEs involving an FTL food, and we may request that persons
make subpart S records for particular FTL foods available to us in a
manner that indicates the particular CTE to which maintained KDEs
apply. We anticipate that grouping KDEs by CTE would be the most
efficient and effective way for firms to provide us with information on
specific FTL foods. We also note that under Sec.  1.1455(c)(3)(ii), we
may request that firms provide to us in an electronic sortable
spreadsheet the information they are required to keep under the CTE
requirements in Sec. Sec.  1.1325 through 1.1350, for the foods and
date ranges or traceability lot codes specified in our request.
    (Comment 513) One comment asserts that although the proposed
exemptions for small entities will help reduce the pressure on small
operations that currently have limited financial or technological
resources, ultimately market demands, access to premium pricing, and
other initiatives will require a more comprehensive traceability rule
in the future with a focus on digitization.
    (Response 513) The final rule is intended to allow for traceability
across the supply chain in a technologically neutral way, while
providing certain exemptions (including for some small entities) for
the reasons described in Section V.E of this document. The rule does
not mandate digitization for the reasons discussed in Response 460.
However, we recognize the importance of digitization in traceability,
and under our 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 activities to support end-
to-end traceability throughout the food safety system, including
enabling food producers of all sizes to participate in a scalable,
cost-effective way. We do not currently have plans to issue a more
comprehensive or digitally focused traceability rule in the future. We
intend to focus on helping covered entities come into compliance with
the final rule and then assessing the effectiveness of the subpart S
requirements.
    (Comment 514) One comment compares this rule with the DSCSA, which
outlines steps to build an electronic, interoperable system to identify
and trace prescription drugs as they are distributed in the United
States. The comment maintains that the DSCSA achieves its traceability
goals through unique (serialized) product identifiers applied to all
packages and homogeneous cases of covered products. The comment
contends that the lot-level traceability envisioned by the proposed
rule would not enable the same level of specificity as serialization.
As an example, the comment describes a situation in which multiple
deliveries of the same traceability lot code of a food to the same
recipient would yield ambiguous results when trying to match a specific
food in inventory at that recipient to a specific reference record and
associated KDEs, such as date of receipt. The comment maintains that if
food cases and items were serialized, it would be possible to link a
specific case of food to a reference record and associated KDEs.
    (Response 514) We believe the comment's comparison of the DSCSA to
subpart S is inapt because the goals and requirements of the provisions
differ. The DSCSA is intended, in part, to protect consumers from
exposure to drugs that may be counterfeit, diverted, stolen, or
otherwise unfit for distribution. While serialization is an important
tool for detecting counterfeit, diverted, or stolen packages or
homogenous cases of drugs, lot-level traceability for foods is
important to determine if contamination found in one package of a
traceability lot of food could be present in another package from the
same traceability lot or other lots of food from the same traceability
lot code source and to help meet the goal of preventing or mitigating
foodborne illness outbreaks as a result of contamination. Moreover, in
contrast to the DSCSA, section 204(d)(1)(L)(iii) of FSMA prohibits
requiring product tracing of FTL foods to the case level. Consequently,
the final rule is designed to facilitate lot-level tracing of FTL
foods, rather than tracing to the case level.
    (Comment 515) Many comments urge FDA to adopt existing global
standards. One comment encourages us to adopt a digital traceability
standard to minimize data capture and sharing errors, despite the
initial costs to small growers and distributors. The comment maintains
that without universal adoption of such a standard, effective food
supply chain traceability will not be possible. Several comments assert
that FDA has successfully partnered with a consensus-based standards
group for the implementation of other healthcare laws, such those
regarding unique device identifiers and the DSCSA. Several comments
assert that GS1 sets forth a comprehensive set of standards that is
widely used in the food industry, and the comments ask that FDA require
or recommend the use of GS1 standards in meeting subpart S traceability
requirements. Some comments assert that we have proposed requirements
that are similar to but different from GS1 standards, and the comments
maintain that these differences could create confusion and
inefficiencies. One comment states that industry has worked with GS1 to
establish a common language and standards for communication of product
data among trading partners and has taken steps to use these standards
to create a process for traceability with the PTI. The comment
maintains that building on this existing platform would avoid confusion
and provide a sound foundation for the implementation of the rule. Some
comments recommend the use of EPCIS standards, maintaining that they
would bring alignment with currently accepted taxonomy and enable more
rapid adoption of new traceability requirements.
    One comment maintains that the final rule should accommodate
different ``data sharing architectures'' within supply chains,
including architectures that do not allow all actors to have access to
full product pedigrees. The comment asserts that GDST interoperability
standards are designed to enable rapid and direct verification of
traceability data. The comment further states that the seafood industry
uses multiple data sharing practices or architectures, some of which
eschew sharing of all product pedigree information with all supply
chain actors. The comment asserts that GDST's approach to
interoperability through standardized CTEs/KDEs and data standards
conducive to digital linking would provide a robust means of achieving
the outcome-based results mandated by the rule while respecting the
diversity of data sharing architectures necessary to the current
business realities of the seafood sector. Therefore, the comment
recommends that we include a reference to the use of GDST standards for
information required under the rule for seafood.
    One comment maintains that although blockchain has been raised as a
possibility for ensuring interoperability, it would be unrealistic to
expect many supply chain entities who still use paper records to be
able to install and operate a technology like blockchain within 2
years. On the other hand, one comment asserts that a platform with
blockchain characteristics and the support for records and
transactional information to fit various production systems may
minimize any data gaps and could lower barriers to entry or

other challenges that may decrease diversification. One comment
suggests that BlockApps would provide a network blockchain-backed
solution for traceability in the agriculture industry. One comment
asserts that any business process that uses fielded data involving
entities, actions, and interplay needs modeling of the data and
associated relationships, and requests that FDA develop entity
relationship diagrams for the proposed rule.
    (Response 515) Although we acknowledge the benefits to enhanced
traceability that many of the systems and technologies discussed in the
comments might provide, as previously stated we have decided to make
subpart S technologically neutral. We think this approach provides
firms with maximal flexibility, allows for changing approaches as new
technology is developed, and is in keeping with Congress's intent as
expressed in section 204(d) of FSMA. Under the final rule, firms may
use any traceability standards or approaches that suit their needs
(including paper records) as long as they enable firms to keep and
provide the information specified under applicable subpart S
requirements. However, we intend to participate in traceability
governance and harmonization efforts with international regulatory
counterparts, including in bodies such as GS1, as part of the New Era
for Smarter Food Safety initiative.
    (Comment 516) Some comments assert that FDA has the statutory
authority to recognize GS1 and other ``voluntary consensus standards''
under the National Technology Transfer and Advancement Act (NTTAA)
(Pub. L. 104-113) and OMB Circular A-119, which the comments describe
as requiring federal agencies to use voluntary consensus standards in
lieu of government-unique standards in their procurement and regulatory
activities, except where inconsistent with law or otherwise
impractical.
    (Response 516) Although we agree that firms may use GS1 and other
standards to facilitate compliance with their subpart S requirements,
we are not prescribing specific standards for the maintenance or
transmission of information required under subpart S. Regarding the
NTTAA and OMB Circular A-119, we note that this rule does not establish
government-unique standards in lieu of voluntary standards. Rather, we
are not prescribing any specific technological standards for the
maintenance and transmission of required traceability information. The
approach we have taken is consistent with the Agency's options under
the framework of the NTTAA and OMB Circular A-119, as well as the
requirement in section 204(d)(1)(C) of FSMA that FDA not prescribe
specific technologies for the maintenance of records.
    (Comment 517) One comment asserts that FDA should adopt category-
specific (e.g., field-grown leafy greens, seafood) global data
standards to meet subpart S requirements, and asks that we convene
meetings and technical working processes to develop these category-
specific global standards.
    (Response 517) To the extent that the comment asks us to adopt
category-specific electronic data standards for use in subpart S, we
decline to do so for the same reasons we decline to adopt specific
electronic data standards more generally (see Response 515). However,
we regularly participate in working groups and workshops that are
engaged in the development of standards for traceability, which often
discuss standards that are specific to certain commodities. We intend
to continue participating in these efforts and providing relevant input
as needed.
    (Comment 518) A few comments ask FDA to recognize approaches such
as the PTI, which the comments maintain goes beyond the requirements of
the rule and includes lot-level tracing via a barcode with a GTIN and
lot number. The comments request that firms that are following other
programs such as the PTI be considered compliant with the requirements
in the final rule.
    (Response 518) Although conducting traceability operations
consistent with the PTI or a similar program might help firms meet many
applicable subpart S requirements, we will not regard such firms to be
in compliance with those requirements simply because they follow such a
program. The PTI and other programs were not designed to ensure
compliance with subpart S, which is not yet in effect. Firms will need
to ensure they are in compliance with applicable subpart S requirements
by the compliance date regardless of their participation in the PTI or
other traceability programs.
    (Comment 519) Several comments ask that FDA not regard the proposed
rule as a component of the Agency's New Era of Smarter Food Safety
initiative. The comments assert that the technology-enabled
traceability envisioned under the New Era initiative will not be
possible until data harmonization and interoperability standards are in
place. Some comments maintain that the rule would prematurely
incorporate recordkeeping requirements that reflect New Era
capabilities without considering criticisms of the initiative itself.
One comment asserts that the rule should not be used as a vehicle to
promote the agenda of the New Era and, as a result, push smaller,
limited-resource firms out of the food industry. Some comments maintain
that there are significant challenges to overcome before the digital
end-to-end traceability system for all foods envisioned in the New Era
initiative can be achieved, including continued industry reliance on
paper recordkeeping and significant diversity in electronic
recordkeeping systems in use. However, one comment requests that we
continue to assist regulated entities in electronic data migration,
tracking, and management under the New Era initiative.
    (Response 519) As noted in our New Era of Smarter Food Safety
Blueprint (Ref. 18), the final rule will serve as the foundation for
much of our traceability work because it will harmonize the KDEs and
CTEs needed for enhanced traceability. We believe that establishing
this foundation for traceability will allow stakeholders in the supply
chain to adopt and leverage digitally enabled technologies, foster
improved data sharing, and introduce approaches that greatly reduce the
time it takes to identify the origin of a contaminated food tied to an
outbreak and/or recall. Although the rule does not require the use of
electronic tracing records, we intend to work collaboratively with the
food industry, including through the New Era of Smarter Food Safety
initiative, to explore ways to encourage firms to voluntarily adopt
tracing technologies and ways to harmonize tracing activities, which
will support interoperability across a variety of technology solutions,
working towards outcomes that are achievable for all sectors.
    (Comment 520) Several comments urge FDA to work with industry to
define best practices and develop standards for interoperability that
will facilitate effective, secure data sharing among all entities in
the supply chain. Several comments urge us to adopt standards for
language and data structure to help ensure that food traceability
systems are interoperable, allowing for swift and accurate exchange of
information throughout the supply chain. Some comments assert that
although we have specified the information we believe is essential for
effective traceability, failing to specify the language/terminology to
be used and the structure/format for the retention and exchange of data
would impair or even prevent effective traceability. One comment
asserts that adopting a standard format would reduce human
transcription errors, reduce database costs, and help prevent trade
barriers.

One comment asserts that the proposed rule appears not to recognize the
necessary standardized data structures for rapid and effective food
traceability and recall; the comment recommends the use of standards
for both globally unique product identifiers and data structures (or
syntax). The comment maintains that with such standards, once a product
is uniquely identified, the data can be pieced together or structured
in a specific order that conveys the history of that product and how it
is transformed and moves through complex supply chains. But the comment
maintains that globally unique identification is lost if this structure
or syntax is garbled, just as the syntax is lost if the product lacks
globally unique identification.
    Some comments maintain that, given the diversity in the food supply
chain, interoperability is necessary for achieving scalability,
lowering adoption costs, and preventing the exclusion or elimination of
smaller supply chain participants. One comment asserts that to ensure
continued market access for small producers, the technology for
traceability must be accessible for all types of operations, and open
source and cost-effective solutions should be promoted. One comment
suggests that FDA encourage food traceability technology providers to
develop solutions that will add little or no overhead so food retailers
of all sizes can participate in a technologically based food safety
system. One comment asserts that being overly prescriptive in the rule
could impede technological evolution and the efficiency with which the
rule is implemented; therefore, the comment suggests that we provide
additional guidance on options for appropriate digital solutions to
ease the burden of compliance and aid successful implementation.
    Some comments recommend that, consistent with GS1 standards, FDA
should better define the need for both data and data structure in its
final rule and acknowledge their shared importance in achieving
interoperability and traceability across the supply chain. One comment
maintains that although adoption of a universal traceability standard
would cause hardship for several entities in the food supply chain,
particularly small growers and even some small distributors, hardships
would be borne across the supply chain and consumers would share in
that cost. One comment maintains that providing support or a platform
for electronic submissions that is secure, interoperable, and not
limited in regard to regions, products, or otherwise may mitigate
issues for scalability across complex supply chains and decrease the
ambiguity of exemptions while addressing issues of technology
implementation and data liability.
    (Response 520) As previously stated, the final rule provides
flexibility to entities subject to subpart S regarding the format and
manner in which required information is kept and provided to subsequent
recipients. However, we recognize the importance of interoperability of
standards and systems for food traceability to be conducted at an
optimal level. We believe that establishing the KDE/CTE requirements
for FTL foods in the final rule is a necessary first step in achieving
standardization and interoperability between tracing systems. As
previously stated, we intend to explore ways to encourage firms to
voluntarily adopt tracing technologies and harmonize tracing
activities, which should enhance interoperability and traceability
throughout the supply chain.
    (Comment 521) Some comments express support for FDA-industry
dialogue or partnerships to develop interoperability standards.
    (Response 521) As previously stated, through the New Era of Smarter
Food Safety initiative and other efforts, we intend to explore ways to
encourage firms to voluntarily adopt tracing technologies and to
harmonize tracing activities to foster interoperability. We welcome all
opportunities to work with the food industry and others to achieve
these goals.
    (Comment 522) Several comments ask that we share information
regarding the systems we will use to receive, store, and access
traceability records required under the rule. The comments also ask for
information on the interoperability of technology systems between FDA
and small businesses, expressing concerns regarding the security and
privacy of data submitted to the Agency.
    (Response 522) In accordance with section 204(c) of FSMA, we are in
the process of developing a product tracing system that would allow
information to be provided to FDA in a secure way and in a variety of
formats similar to other FDA systems that allow industry to provide
information to us. As we progress in the development of this system, we
will keep stakeholders informed on the details of the system, including
options for data formats and sharing the required records and
electronic sortable spreadsheet with FDA. In addition, with respect to
the concerns about the security and privacy of data we receive from
industry, as previously stated, Sec.  1.1455(h) of the final rule
specifies that records we obtain in accordance with subpart S are
subject to the disclosure requirements in part 20, which include, among
other things, provisions regarding the non-disclosure of trade secrets
and commercial or financial information that is privileged or
confidential.
2. Labeling Issues
    (Comment 523) Some comments request clarification on whether we
will provide standards for labels or specify package labeling practices
or label printing standards to ensure data integrity and quality. One
comment encouraged us to require a lot code on consumer pre-packed
products in accordance with the Codex General Standard for Labeling
Prepackaged Foods, section 4.6.
    (Response 523) The rule does not establish labeling requirements
for FTL foods, and in particular does not prescribe standards for
labels or labeling that might include KDE information for FTL foods,
including traceability lot codes. For example, although shippers of FTL
foods are required to provide certain information, including the
traceability lot code, to the immediate subsequent recipient of the
food, the rule does not require that the information be stated on the
label or package of the product.
    (Comment 524) Some comments suggest that we include requirements
for food labels to facilitate traceability. One comment asserts that
for food safety and insurance concerns, all products must be labeled in
a way that is easily traceable to the producer. The comment suggests
that this may be achieved in a variety of ways, such as through the use
of twist ties, bags, food grade stickers, and labels on produce or on
customer order forms. One comment maintains that label requirements
should include at least the lot code, pack date, and brand of the
product. One comment asserts that to allow for adequate tracing, firms
must be required to label all ingredients. The comment maintains that
permitting companies to group many ingredients into spices and natural
flavors can make it impossible to conduct traceback when issues arise.
One comment asserts that it is important that FDA remain technology-
neutral and not place undue requirements on specific data carried
within labels and packaging, but instead retain flexibility for
advances in the means to associate unique identification with
corresponding event data in the database. The comment therefore
encourages us to discuss and approve technology-neutral and ever-
evolving methods of complying with the recordkeeping requirements, but
not to

specify how or where data are stored in data carriers.
    (Response 524) Although the rule includes requirements to provide
certain information to receiving entities in the supply chain, it does
not prescribe the form in which this information must be provided. We
conclude that it is not necessary for the rule to require that
traceability information be placed on food labels to ensure adequate
traceability of FTL foods. Nevertheless, firms may use product labels
to provide information required under subpart S to their supply chain
partners if that suits their business practices.
3. U.S. International Obligations and Standards
    (Comment 525) One comment maintains that the proposed rule would
establish higher standards than those in the Codex Principles for
Traceability/Product Tracing as a Tool Within a Food Inspection and
Certification System (CAC/GL 60-2006) (Ref. 31), and requests that we
provide justification of the necessity of requiring higher levels in
accordance with Article 3.3 of the WTO Agreement on the Application of
Sanitary and Phytosanitary Measures (SPS Agreement). The comment
asserts that although Article 6 of the Codex Principles for
Traceability requires that exporting countries not be required to
replicate the traceability/product tracing tools used by the importing
country, the proposed rule would require exporting countries to adopt
the same traceability standards as those used in the United States. The
comment also maintains that while Article 12 of the Codex Principles
for Traceability specifies that a traceability tool should be able to
identify where the food came from and where it was sent, the proposed
rule would go beyond one step forward/one step back tracing by
requiring that traceability lot codes assigned at food origination be
linked to the KDEs in all CTEs. In addition, the comment asserts that
under Article 16 of the Codex Principles for Traceability, a food
inspection and certification system within which a traceability tool is
applied should not be more trade restrictive than necessary; under
Article 17, application of the traceability tool should be practical,
technically feasible, and economically viable; and under Article 19, a
traceability tool should be implemented when appropriate on a case-by-
case basis. The comment maintains it is often unknown at the earliest
point in the food chain whether foreign agricultural and fishery
products eventually will be exported to the United States. But the
comment asserts that under the proposed rule, all the stakeholders
throughout the food chain must use the same traceability lot code even
for products with only a slight possibility of being exported to the
United States, which the comment contends would require all
stakeholders to entirely update their traceability systems currently in
place, resulting in practically, technically, and economically
difficult situations.
    (Response 525) We believe the rule is consistent with CAC/GL 60-
2006. When developing our proposed rule and in considering comments
when finalizing this rule, we took into account the Codex Principles
for Traceability. To the extent that the rule adopts a more stringent
standard than the Codex Principles for Traceability (CAC/GL 60-2006),
the more stringent approach is limited to achieve the U.S. level of
food safety protection and is based on principles of science and risk.
We do not agree that the rule's recordkeeping requirements are in
conflict with Article 12 because the rule's more extensive
recordkeeping specifications are limited in their application and
justified by risk. Specifically, these requirements apply only to foods
on the FTL, which we developed using the RRM-FT in accordance with the
risk-based factors specified in section 204(d)(2)(A) of FSMA. Also, the
rule provides flexibility to domestic and foreign facilities in that it
does not dictate any specific product or technology that persons
subject to the rule must use to comply with its requirements.
    In addition, the rule's recordkeeping requirements are consistent
with Article 6 of the Codex Principles for Traceability, and we do not
agree with the comment that the rule requires exporting countries to
adopt the same traceability standards as those used in the United
States. Rather, the rule places additional recordkeeping requirements
on specific persons who manufacture, process, pack, or hold foods on
the FTL only if the food will be offered for sale in the United States.
Food imported into the United States must comply with all applicable
FDA requirements; the new traceability requirements would be no
different. We believe that foreign entities are able to anticipate
whether their products will be exported to the United States, and we
note that several existing FDA regulations (such as those concerning
produce safety, preventive controls for human food, egg safety, and
seafood HACCP) apply to food that is imported into the United States.
Because most of the entities that manufacture, process, pack, or hold
foods on the FTL also perform activities that would be covered by one
or more of these existing regulations (if the food is to be exported to
the United States), we believe that these entities will already have
procedures in place to identify whether or not their products will be
exported to the United States. As discussed in Responses 103 and 335,
we believe that U.S. importers will work with their foreign suppliers
to help ensure there is an understanding of the potential for foods on
the FTL to be exported to the United States and the traceability
information required for these products.
    Further, we believe the rule is consistent with our international
trade obligations because it is consistent with the Codex Principles
for Traceability and, to the extent that the rule adopts a more
stringent standard than the relevant Codex guidelines, the more
stringent approach is limited to achieve the U.S. level of food safety
protection and is based on principles of science and risk. For high-
risk foods, the rule sets a higher standard of protection and includes
additional requirements. This approach is consistent with relevant
trade obligations, and the more stringent approach that it takes is
scientifically justified based on public health concerns associated
with the foods subject to the rule, i.e., the foods on the FTL. We
developed the FTL using our RRM-FT, which uses a semiquantitative,
multicriteria decision analysis risk-ranking approach that is
consistent with the factors specified in section 204(d)(2)(A) of FSMA
for use in designating the foods that will be subject to the additional
traceability recordkeeping requirements of the final rule, and which is
operationalized with data relevant to those factors. Using the results
of the RRM-FT, we identified foods to be placed on the FTL, which lists
the foods for which additional traceability records are required under
the final rule. This is consistent with Article 18 of the Codex
Principles for Traceability, which recommends countries take into
account the assessed food safety risks of food products, as well as
Article 19, which states that a traceability tool should be
implemented, when appropriate, on a case-by-case basis.
    The requirements we are establishing are necessary for the
protection of human, animal, or plant life or health, and are
consistent with our international trade obligations, including that the
regulatory requirements are not more trade restrictive than necessary
to achieve the level of food safety protection FDA has established for
U.S. consumers (see also Article 16 of the Codex Principles for
Traceability). The traceability

recordkeeping requirements in the final rule help FDA rapidly and
effectively identify recipients of certain foods to prevent or mitigate
foodborne illness outbreaks and address credible threats of serious
adverse health consequences or death, are tailored to apply to only
high-risk foods offered for sale in the U.S. market, and apply both to
domestic and foreign firms. When developing the final rule, we also
carefully considered the costs of compliance, as recommended by the
Codex guideline, and we have provided flexibility in how firms may meet
the rule's requirements. In addition, we recognize that meeting the
rule's requirements may be especially burdensome for entities with
limited resources, which is why the rule provides certain types of
small entities with a full or partial exemption.
    (Comment 526) One comment, noting that part 5 (``Traceability'') of
Canada's Safe Food for Canadians Regulations (SFCR) has tracing
requirements for fresh produce, suggests that we work together with the
Canadian Food Inspection Agency (CFIA) to standardize requirements on
tracing to reduce the burden on the fresh produce industry.
    (Response 526) We will continue our close cooperation with our
colleagues at the CFIA. As discussed in Response 479, Sec.  1.1455(f)
of the final rule states that entities do not need to duplicate
existing records so long as those records contain the information
required by subpart S, and entities may supplement any such existing
records as necessary to include only the specific information required
by subpart S that is not already contained in their existing records.
Thus, any records that entities maintain to comply with part 5 of the
SFCR can be used to meet the requirements of subpart S, if those
records contain or are amended to contain the required information.
    (Comment 527) One comment asserts that the competent authorities
from other countries will not support the rule and will reciprocate
with equally burdensome rules that will be different and create another
unintended hurdle for U.S. firms that export products to those
countries.
    (Response 527) As we have done throughout this entire rulemaking
process, we intend to continue to work closely with our international
regulatory counterparts, including working toward harmonizing
approaches to traceability internationally. While we received comments
from several countries that expressed concerns about certain aspects of
the rule, such as how records should be maintained by supply chain
entities, the role of importers, and the proposed compliance date, they
nonetheless expressed support for the rule overall. Principally, we
will continue to work with our regulatory counterparts in Codex and in
other international fora to promote food safety by using efficient and
effective global supply chain traceability measures, while minimizing
the regulatory burden on exporters, to the extent practicable.