[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Rules and Regulations]
[Pages 70910-71088]
[FR Doc No: 2022-24417]

Vol. 87

Monday,

No. 223

November 21, 2022

Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 1

Requirements for Additional Traceability Records for Certain Foods

Federal Register / Vol. 87, No. 223 / Monday, November 21, 2022 /
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2014-N-0053]
RIN 0910-AI44

Requirements for Additional Traceability Records for Certain
Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule establishing additional recordkeeping requirements
for persons who manufacture, process, pack, or hold foods the Agency
has designated for inclusion on the Food Traceability List (FTL). The
final rule adopts provisions requiring these entities to maintain
records containing information on critical tracking events in the
supply chain for these designated foods, such as initially packing,
shipping, receiving, and transforming these foods. The requirements
established in the final rule will help the Agency rapidly and
effectively identify recipients of foods to prevent or mitigate
foodborne illness outbreaks and address credible threats of serious
adverse health consequences or death resulting from foods being
adulterated or misbranded. We are issuing this regulation in accordance
with the FDA Food Safety Modernization Act (FSMA).

DATES: This rule is effective January 20, 2023. For the applicable
compliance dates, see section VI ``Effective and Compliance Dates'' in
the SUPPLEMENTARY INFORMATION section of this document.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this final rule,
into the ``Search'' box and follow the prompts, and/or go to the
Dockets Management Staff (HFA-305), 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:
    With regard to the final rule: Katherine Vierk, Office of Analytics
and Outreach, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2122, [email protected].
    With regard to the information collection: Domini Bean, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments on the Proposed Rule
    C. General Overview of the Final Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Food Traceability List
    C. General Comments on the Proposal
    D. Scope (Sec.  1.1300)
    E. Exemptions (Sec.  1.1305)
    F. Definitions (Sec.  1.1310)
    G. Traceability Plan (Sec.  1.1315)
    H. Assignment of Traceability Lot Codes (Sec.  1.1320)
    I. Critical Tracking Events Framework
    J. Records of Harvesting and Cooling (Sec.  1.1325)
    K. Records of Initial Packing (Sec.  1.1330)
    L. Records of First Land-Based Receiving of Food Obtained From a
Fishing Vessel (Sec.  1.1335)
    M. Records of Shipping (Sec.  1.1340)
    N. Records of Receiving (Sec.  1.1345)
    O. Records of Transformation (Sec.  1.1350)
    P. Procedures for Modified Requirements and Exemptions
(Sec. Sec.  1.1360 to 1.1400)
    Q. Waiver Procedures (Sec. Sec.  1.1405 to 1.1450)
    R. Records Maintenance and Availability (Sec.  1.1455)
    S. Consequences of Failure To Comply (Sec.  1.1460)
    T. Updating the FTL (Sec.  1.1465)
    U. Other Issues
VI. Effective and Compliance Dates
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose and Coverage of the Rule

    This final rule, which is part of FDA's implementation of FSMA
(Pub. L. 111-353), establishes additional traceability recordkeeping
requirements for persons who manufacture, process, pack, or hold foods
for which the Agency has determined these additional requirements are
appropriate and necessary to protect the public health in accordance
with FSMA. These traceability recordkeeping requirements will help FDA
rapidly and effectively identify recipients of such foods to prevent or
mitigate a foodborne illness outbreak and address threats of serious
adverse health consequences or death as a result of such foods being
adulterated or misbranded (with respect to allergen labeling) under the
Federal Food, Drug, and Cosmetic Act (FD&C Act). The requirements will
reduce the harm to public health caused by foodborne illness outbreaks
and limit adverse impacts on industry sectors affected by these
outbreaks by improving the ability to quickly and efficiently trace the
movement through the supply chain of foods identified as causing
illness, identify and remove contaminated foods from the marketplace,
and develop mitigation strategies to prevent future contamination.
    We are issuing this rule because Congress directed us, in FSMA, to
establish recordkeeping requirements for foods we designate that would
be additional to the existing traceability recordkeeping requirements
in the FD&C Act and FDA regulations. The existing regulations are
designed to enable FDA to identify the immediate previous sources and
immediate subsequent recipients of foods to address credible threats of
serious adverse health consequences or death to humans or animals. This
final rule adopts additional recordkeeping requirements for foods we
have designated as high-risk foods in accordance with factors specified
by Congress in FSMA. We are listing these foods on an FTL, which is
included as a reference for the final rule. In accordance with FSMA, we
also are publishing the FTL on our website concurrently with the
issuance of the final rule. (See section V.B of this document for more
information on the FTL.)

B. Summary of the Major Provisions of the Final Rule

    The requirements of the final rule are focused on having persons
who manufacture, process, pack, or hold FTL foods maintain and provide
to their supply chain partners specific information (key data elements)
for certain critical tracking events (CTEs) in the handling of the
food, consistent with the developing industry consensus approach to
food tracing. The information that firms must keep and send forward
under the rule varies depending on the type of supply chain activities
they perform with respect to an FTL food, from harvesting or production
of the food through

processing, distribution, and receipt at retail or other point of
service. Central to the proposed requirements is the assignment,
recording, and sharing of traceability lot codes for FTL foods, as well
as linking these lot codes to other information identifying the foods
as they move through the supply chain.
    The final rule requires persons who manufacture, process, pack, or
hold an FTL food to establish and maintain a traceability plan that,
among other things, describes their procedures for maintenance of
records under the new requirements, identification of FTL foods
handled, and assignment of traceability lot codes to FTL foods.
Entities that grow or raise an FTL food (other than eggs) will also
need to keep (as part of their traceability plan) a farm map showing
the area in which the food is grown or raised, including geographic
coordinates for the growing/raising area. Harvesters and coolers of raw
agricultural commodities (RACs) (not obtained from a fishing vessel)
that are on the FTL must keep records of their activities and provide
information on them to the initial packers of these RACs. These initial
packers, along with the first land-based receivers of FTL foods
obtained from a fishing vessel, as well as entities that transform an
FTL food (by manufacturing/processing a food or by changing the food or
its packaging or labeling), must assign a traceability lot code to the
food to help ensure accurate identification of the food as it moves
through the supply chain, as well as maintain other records relating to
their activities. Shippers and receivers of FTL foods must keep records
of these actions, and shippers must provide the traceability lot code
and other information identifying the food to the recipients of the
food, including information relating to the traceability lot code
source (i.e., the entity that assigned the traceability lot code to the
food). To avoid disclosing confidential information about their
suppliers, instead of directly identifying the traceability lot code
source of an FTL food, the shipper may instead choose to provide a
traceability lot code source ``reference,'' such as an FDA Food
Facility Registration number or a web address (which could be
configured to require authentication for access), that provides an
alternative means for FDA to identify and contact the traceability lot
code source for the food. Taken together, these core subpart S
requirements establish a structure for maintaining and providing
traceability information that will enable FDA to more rapidly and
effectively identify the source of contamination when investigating a
foodborne illness outbreak than is possible under existing traceability
recordkeeping requirements.
    The final rule exempts certain small producers (including small
produce farms, shell egg producers, and other producers of RACs) and,
at the other end of the supply chain, certain small retail food
establishments (RFEs) and restaurants. The rule also provides several
other exemptions, including, but not limited to, those for the
following: farms when food is sold or donated directly to consumers;
food produced and packaged on a farm whose packaging maintains product
integrity and prevents subsequent contamination; foods that receive
certain types of processing, including produce that receives commercial
processing that adequately reduces the presence of microorganisms of
public health significance, shell eggs that receive a certain
treatment, foods that are subjected to a kill step, and foods changed
such that they are no longer on the FTL; produce rarely consumed raw;
certain raw bivalve molluscan shellfish; persons who manufacture,
process, pack, or hold FTL foods during or after the time when the food
is within the exclusive jurisdiction of the U.S. Department of
Agriculture (USDA); commingled RACs (not including fruits and
vegetables subject to the produce safety regulation); RFEs and
restaurants purchasing directly from a farm; certain ad hoc purchases
by RFEs and restaurants from other such entities; farm to school and
farm to institution programs; fishing vessels; transporters; nonprofit
food establishments; and food for research or evaluation. (See section
V.E of this document for more information on exemptions provided in the
final rule.)
    In addition to the exemptions codified in the final rule, the rule
establishes procedures under which persons may request modified
requirements or an exemption from the new traceability recordkeeping
requirements for a specific food or a type of entity on the grounds
that application of the requirements to that food or type of entity is
not necessary to protect the public health. The rule also establishes
procedures for requesting a waiver of one or more of the requirements
for an individual entity or a type of entity on the grounds that having
to meet the requirements would result in an economic hardship due to
the unique circumstances of that entity or type of entity.
    The rule specifies that persons subject to subpart S may have
another entity establish and maintain required records on their behalf,
although the person remains responsible for ensuring the records can be
provided onsite to FDA within 24 hours of our request for official
review. In addition, when necessary to help prevent or mitigate a
foodborne illness outbreak, assist in the implementation of a recall,
or otherwise address a threat to public health, firms must provide an
electronic sortable spreadsheet containing information FDA requests on
CTEs involving particular FTL foods for the date ranges or traceability
lot codes specified in our request. Certain smaller entities are exempt
from the requirement to provide this information in an electronic
sortable spreadsheet, though they must still provide the information in
other electronic or paper form. To help speed our access to information
in such exigent circumstances, we may request the information remotely
(e.g., by phone) instead of onsite at the entity's place of business.
    In response to many comments expressing concern about the ability
of some entities to come into compliance within 2 years after the
rule's effective date (as proposed), the final rule extends the
compliance date for all persons subject to the rule to 3 years after
the effective date. In this interim period, we intend to provide
outreach and training, as well as guidance and other materials, to help
all sectors of the food industry come into compliance with the new
traceability recordkeeping requirements applicable to them under the
new regulation.

C. Legal Authority

    FSMA directs FDA to publish a notice of proposed rulemaking to
establish recordkeeping requirements, in addition to the requirements
under the FD&C Act and existing regulations, for facilities that
manufacture, process, pack, or hold foods FDA designates. FSMA also
directs FDA to designate the foods for which such additional
recordkeeping requirements are appropriate and necessary to protect the
public health.

D. Costs and Benefits

    This final rule will impose compliance costs on covered entities by
increasing the number of records that are required for covered foods.
Entities that manufacture, process, pack, or hold covered foods will
incur costs to establish and maintain a traceability plan and
traceability records and one-time costs of reading and understanding
the rule. Some firms may also incur initial and recurring capital
investment and training costs for systems that will enable them to
keep, maintain, and make available to other supply chain entities (and
to us upon our request)

their traceability records. We estimate that the present value of costs
of the rule over 20 years ranges from about $0.7 billion to $24.6
billion, with a primary estimate of about $6 billion in 2020 dollars at
a 7 percent discount rate, and from $0.8 billion to $33.7 billion, with
a primary estimate of $8.2 billion at a 3 percent discount rate. At a 7
percent discount rate, annualized costs range from about $63 million to
$2.3 billion, with a primary estimate of $570 million per year. At a 3
percent discount rate, annualized costs range from about $53 million to
$2.3 billion, with a primary estimate of $551 million per year.
    By allowing faster identification of contaminated foods and
increasing rates of successful tracing completions, the rule will
result in public health benefits if foodborne illnesses directly
related to those outbreaks are averted. This might also lead to more
efficient use of FDA and industry resources needed for outbreak
investigations by potentially resulting in more precise recalls and
avoidance of overly broad market withdrawals and advisories for covered
foods. We estimate public health benefits using several case studies of
outbreak tracebacks for four pathogens associated with illnesses caused
by covered foods. We calculate these benefits based on an estimated 83
percent reduction of traceback time resulting from the requirements of
this rule. These benefits have a tendency toward underestimation of the
total public health benefits because these four pathogens do not
represent the total burden of all illnesses associated with foods on
the FTL. However, adjustments made for undiagnosed and unattributed
illnesses may have the opposite tendency of overstating both illnesses
and benefits associated with listed foods. The present value of health
benefits over 20 years ranges from about $0.6 billion to $23.7 billion,
with a primary estimate of $8.3 billion at a 7 percent discount rate,
and from about $0.9 billion to $34.5 billion, with a primary estimate
of $12.0 billion at a 3 percent discount rate. The annualized monetized
health benefits range from $59 million to $2.2 billion, with a primary
estimate of $780 million at a 7 percent discount rate, and from $61
million to $2.3 billion, with a primary estimate of $810 million at a 3
percent discount rate.
    The present value of (non-health) benefits from avoiding overly
broad recalls and market withdrawals and advisories over 20 years
ranges from about $2.5 billion to $18.8 billion, with a primary
estimate of $6.1 billion at a 7 percent discount rate, and from about
$3.6 billion to $27.3 billion, with a primary estimate of $8.9 billion
at a 3 percent discount rate. At a 7 percent discount rate over 20
years, these benefits range from $233 million to $1.8 billion, with a
primary estimate of $575 million. At a 3 percent discount rate over 20
years, these benefits range from $242 million to $1.8 billion, with a
primary estimate of $596 million. Additional benefits of the rule may
include increased food supply system efficiencies, such as improvements
in supply chain management and inventory control; more expedient
initiation and completion of recalls; avoidance of costs due to
unnecessary preventive actions by consumers; reduction of food waste;
and other food supply system efficiencies due to a standardized
approach to traceability, including an increase in transparency and
trust and potential deterrence of fraud.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

------------------------------------------------------------------------
       Abbreviation or acronym                   What it means
------------------------------------------------------------------------
ASN.................................  Advance shipping notice.
BOL.................................  Bill of lading.
CSA.................................  Community supported agriculture.
CTE.................................  Critical tracking event.
FDA.................................  Food and Drug Administration.
FD&C Act............................  Federal Food, Drug, and Cosmetic
                                       Act.
FOIA................................  Freedom of Information Act.
FSIS................................  Food Safety and Inspection
                                       Service.
FSMA................................  FDA Food Safety Modernization Act.
FTL.................................  Food Traceability List.
FTE.................................  Full-time equivalent employee.
GPS.................................  Global positioning system.
HACCP...............................  Hazard analysis and critical
                                       control point.
KDE.................................  Key data element.
LACF................................  Low-acid canned food.
NSSP................................  National Shellfish Sanitation
                                       Program.
OMB.................................  Office of Management and Budget.
PTI.................................  Produce Traceability Initiative.
RCR.................................  Rarely consumed raw.
RAC.................................  Raw agricultural commodity.
RTE.................................  Ready-to-eat.
RFR.................................  Reportable Foods Registry.
SECG................................  Small entity compliance guide.
SOI.................................  Standards of identity.
SME.................................  Subject matter expert.
USDA................................  U.S. Department of Agriculture.
WGS.................................  Whole genome sequencing.
------------------------------------------------------------------------

III. Background

A. Need for the Regulation/History of This Rulemaking

    On January 4, 2011, President Obama signed FSMA (Pub. L. 111-353)
into law. As a component of FSMA's overhaul of U.S. food safety law to
ensure the safety and security of the nation's food supply, section 204
of FSMA requires FDA to establish recordkeeping requirements for
facilities that manufacture, process, pack, or hold foods the Agency
designates as high risk to facilitate the rapid and effective
traceability of such foods. These recordkeeping requirements are
additional to the food traceability requirements under section 414 of
the FD&C Act (21 U.S.C. 350c) (added to the FD&C Act in title III,
subtitle A, section 306, of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L.
107-188)) and the implementing regulation in subpart J of part 1 of
title 21 of the Code of Federal Regulations (CFR) (Sec. Sec.  1.326 to
1.368) (the subpart J regulation).
    Congress directed FDA to adopt the subpart J recordkeeping
requirements to allow the Agency to identify the immediate previous
sources and immediate subsequent recipients of foods (commonly referred
to as ``one-up, one-back'' recordkeeping) to address credible threats
of serious adverse health consequences or death to humans or animals.
We issued a final rule promulgating the subpart J regulation in 2004
(69 FR 71562, December 9, 2004).
    In the case of a foodborne illness outbreak or evidence of
contaminated food, the ability to follow the movement of foods through
the supply chain--called product tracing or traceability--helps
government agencies identify the points in the food supply chain,
including the source of the product, where contamination may have
occurred and, working with industry, remove the food from the
marketplace. Efficient traceability enables the government and the food
industry to take action more quickly to prevent illnesses and reduce
economic harm.
    In the years following the adoption of the subpart J regulation,
FDA has learned that the one-up, one-back recordkeeping requirements in
those regulations do not capture all the data elements necessary to
effectively and rapidly link shipments of food through each point in
the supply chain. Among the significant gaps in the subpart J
requirements are the following:
     The lack of coverage of all sectors involved in food
production,

distribution, and sale (e.g., farms and restaurants are exempt);
     The lack of uniform data collection (e.g., regarding the
source of food ingredients used in each lot of finished product; no
requirement to record a lot code or other identifier for all foods);
and
     An inability to link incoming product with outgoing
product within a firm and from one point in the supply chain to the
next (see 85 FR 59984 at 59990, September 23, 2020).
    These shortcomings of the subpart J regulation have hindered FDA
outbreak investigations in many ways, including by making it more
difficult to obtain tracing information from point-of-service firms
that are exempt from the regulations. Even when such information is
available, the records required under subpart J often are inadequate to
facilitate swift and accurate traceback through the distribution chain
to the producer of a contaminated food.
    Recognizing the need for improvement in food traceability, in
section 204(d)(1) of FSMA, Congress directed the Agency to adopt
additional recordkeeping requirements to prevent or mitigate foodborne
illness outbreaks and address credible threats of serious adverse
health consequences or death to humans or animals resulting from foods
being adulterated under section 402 of the FD&C Act (21 U.S.C. 342) or
misbranded with respect to allergen labeling under section 403(w) of
the FD&C Act (21 U.S.C. 343(w)). The additional recordkeeping
requirements set forth in this final rule, which will be codified in 21
CFR part 1, subpart S (the subpart S regulation), will help FDA more
effectively follow the movement of food products and ingredients on the
FTL (``FTL foods'') both backward and forward throughout the supply
chain.
    Even before the enactment of FSMA, FDA had been considering ways to
improve food product traceability and increase the speed and accuracy
of our traceback and traceforward investigations, including holding
public meetings and engaging in a pilot tracing project. Following the
enactment of FSMA, FDA continued its work to improve food product
traceability and to lay the groundwork for this rulemaking. Section
204(a) of FSMA directed FDA to establish pilot projects in coordination
with the food industry to explore and evaluate methods to rapidly and
effectively identify recipients of food. At FDA's request, and in
accordance with that provision, the Institute of Food Technologists
(IFT) conducted two product tracing pilots and issued a 2012 final
report to FDA regarding those pilot studies (Ref. 1). In 2016, in
accordance with section 204(a)(3) of FSMA, FDA submitted a Report to
Congress that discussed the findings of the pilot projects and included
recommendations for improving the tracking and tracing of food (Ref.
2).
    In addition, on February 4, 2014, we issued a notice in the Federal
Register (79 FR 6596) seeking public comment, scientific data, and
other information to inform our draft approach to identifying high-risk
foods. Section 204(d)(2)(A) of FSMA requires that the designation of
high-risk foods be based on the following factors:
     The known safety risks of a particular food, including the
history and severity of foodborne illness outbreaks attributed to such
food, taking into consideration foodborne illness data collected by the
Centers for Disease Control and Prevention (CDC);
     the likelihood that a particular food has a high potential
risk for microbiological or chemical contamination or would support the
growth of pathogenic microorganisms due to the nature of the food or
the processes used to produce such food;
     the point in the manufacturing process of the food where
contamination is most likely to occur;
     the likelihood of contamination and steps taken during the
manufacturing process to reduce the possibility of contamination;
     the likelihood that consuming a particular food will
result in a foodborne illness due to contamination of the food; and
     the likely or known severity, including health and
economic impacts, of a foodborne illness attributed to a particular
food.
    On September 23, 2020, FDA published a proposed rule entitled
``Requirements for Additional Traceability Records for Certain Foods''
(85 FR 59984), to establish additional recordkeeping requirements for
foods on the FTL, a proposed version of which was made available in the
public docket for the rulemaking as well as on our website (Ref. 3). At
the same time, we made available our ``Methodological Approach to
Developing a Risk-Ranking Model for Food Tracing FSMA Section 204 (21
U.S.C. 2223)'' (RRM-FT Methodological Approach Report) (Ref. 4), which
described how we generated the results from the risk-ranking model for
food tracing (``RRM-FT'' or ``the Model'') that we used to help develop
the FTL. The Model, which was peer reviewed, used a semiquantitative,
multicriteria decision analysis risk-ranking approach, consistent with
the factors set forth in section 204(d)(2) of FSMA, and it was
operationalized with data relevant to those factors to generate results
for foods we regulate (85 FR 59984 at 59991). We also made available a
memorandum entitled ``Designation of the Food Traceability List Using
the Risk-Ranking Model for Food Tracing'' (Ref. 5), explaining how we
designated the foods on the FTL using the results of the RRM-FT.
    As stated in the preamble to the proposed rule, the proposed
traceability requirements were focused on having persons who
manufacture, process, pack, or hold FTL foods maintain and share
specific key data elements (KDEs) for certain CTEs in a food's supply
chain, consistent with the developing industry consensus approach to
food tracing. The information that firms would need to keep and send to
their supply chain partners would vary depending on the type of supply
chain activity they were performing with respect to an FTL food, from
production of the food through processing, distribution, and receipt at
retail or other point of service. Central to the proposed requirements
is the assignment, recording, and sharing of traceability lot codes and
traceability lot code sources (i.e., the entity that assigned the
traceability lot code) for FTL foods, as well as linking the
traceability lot codes to other information identifying the foods as
they move through the supply chain.
    Since the publication of the proposed rule, there is still a need
for improved traceability. Foodborne illness continues to have serious
public health impacts. In the United States, there are approximately
800 foodborne illness outbreaks reported every year from all foods
according to CDC outbreak surveillance reports, including about 200
outbreaks caused by foods covered by this rule (Refs. 6, 16). We
estimate that nearly 770,000 illnesses annually in the United States
are associated with foods covered by the rule (Ref. 16). Further, many
Americans, besides those who become ill, are impacted by supply chain
disruptions and temporary shortages due to overly broad recalls and
less than fully efficient traceback investigations. A lack of
consistent recordkeeping continues to hinder FDA's traceback
investigations (Ref. 7). As described in the proposed rule, we have
sometimes been unable to determine links between illnesses and specific
product distribution due to inconsistent, unstandardized recordkeeping,
lack of a deliberate method to connect records, and the frequent lack
of lot tracing regarding distribution to specific retail locations. A
lack of effective traceability

throughout the food supply has led to delays in product recalls and
notification to the public, allowing potentially contaminated foods to
remain on the market longer. While this rulemaking does not prevent the
occurrence of outbreaks, these recordkeeping requirements can help
identify the source of the contaminated food more quickly, potentially
reducing the severity of the outbreak.
    While parts of the industry have made progress in implementing
traceability systems, the success has been confined to a subset of
firms and product types, primarily in large firms where there is
vertical integration in the supply chain or across the production of
relatively homogenous products. Coordination through the supply chain
across a wide range of firms varying in size, product mix, and
production systems remains burdensome for many firms, especially those
not vertically integrated. It is unlikely that without regulation the
industry will ever achieve the level of systematic uniformity,
accuracy, and efficiency needed to protect public health. The final
rule--which applies only to covered foods and maintains the CTE/KDE
structure of the proposed rule, but with modifications to address
concerns raised in comments--provides a uniform set of requirements and
expectations for traceability, reducing the challenges of coordination
through the supply chain. The rule will greatly improve the efficiency
and accuracy of FDA's traceback and traceforward operations, which
should have a direct impact on the public health by allowing us to more
quickly identify the source of contaminated food and remove it from the
market.

B. Summary of Comments to the Proposed Rule

    Although many comments express support for the proposed rule and
its purposes, a number of comments request changes to simplify the
traceability recordkeeping and record-sending requirements and reduce
the burden of the rule on entities throughout the supply chain. Several
comments ask that we reduce and simplify the CTEs for which records
must be kept and the KDEs that firms must maintain for each event.
While many comments acknowledge the importance of documenting the
traceability lot code as an FTL food moves through the supply chain,
several question how much information on the product and its producer
is necessary or appropriate to share with downstream supply chain
members.
    Some comments ask that we broaden the circumstances under which a
traceability lot code may be assigned. Several comments express concern
about the feasibility of establishing requirements applicable to the
``first receiver'' of an FTL food, suggesting that others in the supply
chain would be better suited to having and maintaining the required
KDEs. Several comments request that we streamline the KDEs to be
documented for shipping, receiving, and transformation events, and
revise the information that shippers would be required to send to the
recipients of the FTL foods, including the requirements applicable to
farms.
    Several comments ask that we clarify the scope of proposed
exemptions from the FTL recordkeeping requirements, with some
requesting that we broaden those exemptions to cover additional foods
and/or firms. In particular, many comments maintain that having to
comply with the rule would impose an undue burden on small farms and
small RFEs, as well as other small supply chain firms. In addition,
some comments request that we establish additional exemptions
(different from those we proposed) for certain foods and supply chain
entities.
    Many comments object to the proposed requirement to make available
to FDA, when necessary to help prevent or mitigate a foodborne illness
outbreak, assist in the implementation of a recall, or otherwise
address a threat to public health, an electronic sortable spreadsheet
containing information in required traceability records for specified
FTL foods and date ranges. In addition, although the proposed rule
would permit firms to use existing records to meet the proposed
recordkeeping requirements, several comments assert that the proposed
rule would require unnecessary creation of duplicative records.
    The comments generally express support for the proposed RRM-FT we
used to determine the foods on the FTL, although some comments take
issue with certain aspects of the Model as well as how we used it to
generate the FTL. In addition, many comments request clarification as
to whether particular foods or food products are on the FTL, and
several comments ask that the final FTL not include several foods that
were on the proposed FTL.

C. General Overview of the Final Rule

    In response to comments we received, we have made several changes
to the proposed traceability recordkeeping requirements for FTL foods
that will make the final rule easier for supply chain entities to
understand and comply with, while still ensuring that the rule
substantially improves FDA's ability to respond quickly and effectively
to foodborne illness outbreaks involving foods on the FTL. We believe
the final rule more closely aligns the FTL recordkeeping requirements
with developing industry best practices and effectively addresses
stakeholder concerns about the complexity of the requirements and the
need to protect the confidentiality of commercial information regarding
suppliers.
    The final rule includes changes to the requirements for a
traceability plan (referred to in the proposed rule as ``traceability
program records''), including more streamlined requirements for what
must be included in the plan and deletion of the proposed requirement
to maintain a list of FTL foods shipped. In addition, for those who
grow or raise an FTL food, the final rule requires the retention of a
relevant farm map containing geographic coordinates instead of the
proposed records documenting the growing area coordinates for
individual traceability lots of the food.
    The final rule also includes changes to certain of the CTEs for
which persons subject to the rule must maintain KDEs. Instead of
requiring the ``first receiver'' of an FTL food (which the proposed
rule had defined as the first person other than a farm who purchases
and takes physical possession of an FTL food that has been grown,
raised, caught, or (in the case of a non-produce commodity) harvested)
to maintain information on the origination, harvesting, cooling, and
packing of food, the final rule places similar responsibility on the
initial packer of a RAC (other than a food obtained from a fishing
vessel) or the first land-based receiver of a food obtained from a
fishing vessel. The KDEs required for shipping and receiving FTL foods
have been streamlined and the shipping KDEs no longer apply to
shipments that occur before a RAC is initially packed. A new CTE has
been added to explain the requirements specific to harvesting and
cooling of RACs before they are initially packed, and the CTEs for
``transformation'' and ``creation'' of an FTL food have been combined
and clarified under a single transformation CTE.
    The final rule includes changes to protect the privacy of
individuals employed by supply chain entities and the confidentiality
of business information concerning suppliers. To address the former,
the final rule only requires firms to identify a point of contact
within their traceability plan and the point of contact can be
identified as a job title (along with a phone number), instead of the
person's

name; all of the proposed requirements to provide a point of contact as
part of the records sent to other supply chain entities have been
deleted. In response to concerns about having to pass forward
information on the traceability lot code generator for an FTL food,
which could reveal information about a firm's suppliers, the final rule
permits firms to provide a 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, such as
through a web address that provides the location description for the
traceability lot code source. If the firm uses a web address as the
traceability lot code source reference, the associated website may
employ reasonable security measures, such as only being accessible to a
government email address, provided the Agency has access to the
information at no cost and without delay.
    The final rule includes revisions to several of the proposed
exemptions from the rule (generally broadening or clarifying the
exemptions). We revised exemptions for certain small producers, and we
expanded the exemption for farms when food is sold directly to
consumers, such that it now covers donations as well as sales. We
expanded the exemptions for foods that are subjected to a kill step and
commingled RACs to extend these partial exemptions to include certain
situations where it is known that the food will be subjected to a kill
step (by an entity other than an RFE, restaurant, or consumer) or be
commingled in the future, and to include foods that will be changed
such that they are no longer on the FTL. Regarding the co-proposal for
the exemption of small RFEs (full exemption vs. exemption from the
requirement to make available, in certain circumstances, an electronic
sortable spreadsheet containing requested tracing information), we have
elected to fully exempt certain small RFEs and restaurants but also
exempt from the requirement to provide a sortable spreadsheet somewhat
larger but still relatively small RFEs and restaurants (along with
certain farms and other entities that are relatively small). In
addition, in response to comments we have added other partial or full
exemptions from the regulations, including for the following: raw
bivalve molluscan shellfish; persons who manufacture, process, pack, or
hold certain foods subject to regulation by the USDA; certain ad hoc
purchases by RFEs and restaurants from other such entities; and food
for research or evaluation.
    We have not made any changes to the risk-ranking model that we
developed, consistent with the factors set forth in section
204(d)(2)(A) of FSMA, to determine which foods should be placed on the
FTL. With respect to the FTL itself, on January 11, 2021, we provided
additional clarity on the foods on the proposed FTL in response to
stakeholder input following the release of the proposed rule (Ref. 8).
With the publication of the final rule, we are providing additional
description and clarification of FTL foods, including examples of foods
that are and are not considered part of certain commodity designations
on the FTL.
    Finally, in response to the many comments expressing concern about
the ability of farms, manufacturers, distributors, retail food
establishments, and others to come into compliance with the new
traceability recordkeeping requirements within 2 years after the
effective date of the final rule, as we had proposed, we are extending
the compliance date for all persons subject to the rule to 3 years
after its effective date (which is 60 days after the date of
publication of the final rule in the Federal Register).

IV. Legal Authority

    Under section 204(d) of FSMA, in order to rapidly and effectively
identify recipients of a food to prevent or mitigate a foodborne
illness outbreak and to address credible threats of serious adverse
health consequences or death to humans or animals as a result of such
food being adulterated under section 402 of the FD&C Act or misbranded
under section 403(w) of the FD&C Act, FDA was required to publish a
proposed rule to establish recordkeeping requirements, in addition to
the requirements under section 414 of the FD&C Act and the subpart J
regulation, for facilities that manufacture, process, pack, or hold
foods that FDA designates under section 204(d)(2) of FSMA as high-risk
foods. We published the required proposed rule on September 23, 2020,
and we are completing the rulemaking process with this final rule by
establishing the subpart S regulation. We are promulgating this
regulation under the following authorities:
     Section 204 of FSMA, the specific provisions of which are
discussed throughout this document;
     Section 701(a) of the FD&C Act (21 U.S.C. 371(a)), which
provides FDA with the authority to promulgate regulations for the
efficient enforcement of the FD&C Act; and
     Sections 311, 361, and 368 of the Public Health Service
Act (PHS Act) (42 U.S.C. 243, 264, and 271), which relate to
communicable disease, including by providing FDA with authority to make
and enforce such regulations as in FDA's judgment are necessary to
prevent the introduction, transmission, or spread of communicable
diseases from foreign countries into the States or possessions, or from
one State or possession into any other State or possession (see section
361(a) of the PHS Act).

The legal authority for this rulemaking is discussed further in the
preamble to the proposed rule (see 85 FR 59984 at 59993 and 59994).

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received approximately 1,100 comment submissions on the proposed
rule to establish traceability recordkeeping requirements for persons
who handle FTL foods (including comments on the FTL itself and the
risk-ranking model used to develop it) by the close of the comment
period, each containing one or more comments on one or more issues. We
received comments from consumers, consumer groups, trade organizations,
farmers, industry (e.g., food manufacturers, processors, distributors),
public health organizations, State and local governments, foreign
governments and organizations, and others.
    We describe and respond to the comments in Sections V.B through V.U
of this document, as well as certain comments in Sections VI through
IX. We have numbered each comment to help distinguish between different
comments. We have grouped similar comments together under the same
number, and, in some cases, we have separated different issues
discussed in the same comment and designated them as distinct comments
for purposes of our responses. The number assigned to each comment or
comment topic is purely for organizational purposes and does not
signify the comment's value or importance or the order in which
comments were received.

B. Food Traceability List

    Included as a reference to this final rule (and as seen in table 1)
is the FTL, which sets forth the foods that will be subject to the
subpart S requirements. In accordance with section 204(d)(2)(B) of FSMA
and Sec.  1.1300 of the final rule, we are publishing the FTL on our
website concurrently with the issuance of this final rule. We included
as a reference to the proposed rule the RRM-FT Methodological Approach
Report (Ref.

4), which discusses the risk-ranking model for food tracing we used to
determine the foods on the FTL. As stated in the proposed rule, the
RRM-FT uses a semiquantitative, multicriteria decision analysis risk-
ranking approach that is consistent with the factors specified in
section 204(d)(2) of FSMA for use in designating the foods that will be
subject to the additional traceability recordkeeping requirements and
is operationalized with data relevant to those factors.
    Using the results of the RRM-FT, we tentatively identified foods
for which additional traceability records will be required, as we
discussed in the Designation of the FTL Memorandum (Ref. 5). Based on
that analysis, we developed a tentative list of FTL foods (Ref. 3). In
response to questions and comments we received regarding the tentative
FTL, in January 2021 we updated the table on our website showing the
tentative FTL (Ref. 8). The updated table did not reflect a change in
which foods were on the tentative FTL, but it included text to clarify
the food products that are included in certain categories of foods on
the tentative FTL.
    Table 1 shows the current FTL that we are publishing with this
final rule. The FTL being published with the final rule has not changed
from the tentative list issued with the proposed rule. However, we have
provided additional revisions to the descriptions of the commodities on
the FTL to address some of the comments we received and provide greater
clarity. The process for changing the FTL, which includes advance
notice and an opportunity for the public to provide comment, is
discussed in Section V.T of this document. We intend to update the FTL
approximately every 5 years, subject to available resources. For the
initial update to the FTL following publication of the final rule, we
will take into consideration the compliance date for the final rule
when deciding when to begin the process.

                     Table 1--Food Traceability List
------------------------------------------------------------------------
      Food traceability list                     Description
------------------------------------------------------------------------
Cheeses, other than hard cheeses,
 specifically:
     Cheese (made from      Includes soft unripened/fresh soft
     pasteurized milk), fresh soft   cheeses. Examples include, but are
     or soft unripened.              not limited to, cottage, chevre,
                                     cream cheese, mascarpone, ricotta,
                                     queso blanco, queso fresco, queso
                                     de crema, and queso de puna. Does
                                     not include cheeses that are
                                     frozen, shelf stable at ambient
                                     temperature, or aseptically
                                     processed and packaged.
     Cheese (made from      Includes soft ripened/semi-soft
     pasteurized milk), soft         cheeses. Examples include, but are
     ripened or semi-soft.           not limited to, brie, camembert,
                                     feta, mozzarella, taleggio, blue,
                                     brick, fontina, monterey jack, and
                                     muenster. Does not include cheeses
                                     that are frozen, shelf stable at
                                     ambient temperature, or aseptically
                                     processed and packaged.
     Cheese (made from      Includes all cheeses made with
     unpasteurized milk), other      unpasteurized milk, other than hard
     than hard cheese \1\.           cheeses. Does not include cheeses
                                     that are frozen, shelf stable at
                                     ambient temperature, or aseptically
                                     processed and packaged.
Shell eggs........................  Shell egg means the egg of the
                                     domesticated chicken.
Nut butters.......................  Includes all types of tree nut and
                                     peanut butters. Examples include,
                                     but are not limited to, almond,
                                     cashew, chestnut, coconut,
                                     hazelnut, peanut, pistachio, and
                                     walnut butters. Does not include
                                     soy or seed butters.
Cucumbers (fresh).................  Includes all varieties of fresh
                                     cucumbers.
Herbs (fresh).....................  Includes all types of fresh herbs.
                                     Examples include, but are not
                                     limited to, parsley, cilantro, and
                                     basil. Herbs listed in 21 CFR
                                     112.2(a)(1), such as dill, are
                                     exempt from the requirements of the
                                     rule under 21 CFR 1.1305(e).
Leafy greens (fresh)..............  Includes all types of fresh leafy
                                     greens. Examples include, but are
                                     not limited to, arugula, baby leaf,
                                     butter lettuce, chard, chicory,
                                     endive, escarole, green leaf,
                                     iceberg lettuce, kale, red leaf,
                                     pak choi, Romaine, sorrel, spinach,
                                     and watercress. Does not include
                                     whole head cabbages such as green
                                     cabbage, red cabbage, or savoy
                                     cabbage. Does not include banana
                                     leaf, grape leaf, and leaves that
                                     are grown on trees. Leafy greens
                                     listed in Sec.   112.2(a)(1), such
                                     as collards, are exempt from the
                                     requirements of the rule under Sec.
                                       1.1305(e).
Leafy greens (fresh-cut)..........  Includes all types of fresh-cut
                                     leafy greens, including single and
                                     mixed greens.
Melons (fresh)....................  Includes all types of fresh melons.
                                     Examples include, but are not
                                     limited to, cantaloupe, honeydew,
                                     muskmelon, and watermelon.
Peppers (fresh)...................  Includes all varieties of fresh
                                     peppers.
Sprouts (fresh)...................  Includes all varieties of fresh
                                     sprouts (irrespective of seed
                                     source), including single and mixed
                                     sprouts. Examples include, but are
                                     not limited to, alfalfa sprouts,
                                     allium sprouts, bean sprouts,
                                     broccoli sprouts, clover sprouts,
                                     radish sprouts, alfalfa & radish
                                     sprouts, and other fresh sprouted
                                     grains, nuts, and seeds.
Tomatoes (fresh)..................  Includes all varieties of fresh
                                     tomatoes.
Tropical tree fruits (fresh)......  Includes all types of fresh tropical
                                     tree fruit. Examples include, but
                                     are not limited to, mango, papaya,
                                     mamey, guava, lychee, jackfruit,
                                     and starfruit. Does not include non-
                                     tree fruits such as bananas,
                                     pineapple, dates, soursop, jujube,
                                     passionfruit, Loquat, pomegranate,
                                     sapodilla, and figs. Does not
                                     include tree nuts such as coconut.
                                     Does not include pit fruits such as
                                     avocado. Does not include citrus,
                                     such as orange, clementine,
                                     tangerine, mandarins, lemon, lime,
                                     citron, grapefruit, kumquat, and
                                     pomelo.
Fruits (fresh-cut)................  Includes all types of fresh-cut
                                     fruits. Fruits listed in Sec.
                                     112.2(a)(1) are exempt from the
                                     requirements of the rule under Sec.
                                       1.1305(e).
Vegetables other than leafy greens  Includes all types of fresh-cut
 (fresh-cut).                        vegetables other than leafy greens.
                                     Vegetables listed in Sec.
                                     112.2(a)(1) are exempt from the
                                     requirements of the rule under Sec.
                                       1.1305(e).
Finfish (fresh and frozen),
 specifically:
     Finfish, histamine-    Includes all histamine-producing
     producing species.              species of finfish. Examples
                                     include, but are not limited to,
                                     tuna, mahi mahi, mackerel,
                                     amberjack, jack, swordfish, and
                                     yellowtail.
     Finfish, species       Includes all finfish species
     potentially contaminated with   potentially contaminated with
     ciguatoxin.                     ciguatoxin. Examples include, but
                                     are not limited to, grouper,
                                     barracuda, and snapper.
     Finfish, species not   Includes all species of finfish not
     associated with histamine or    associated with histamine or
     ciguatoxin.                     ciguatoxin. Examples include, but
                                     are not limited to, cod, haddock,
                                     Alaska pollock, salmon, tilapia,
                                     and trout.\2\ Siluriformes fish,
                                     such as catfish, are not
                                     included.\3\

Smoked finfish (refrigerated and    Includes all types of smoked
 frozen).                            finfish, including cold smoked
                                     finfish and hot smoked finfish.\4\
Crustaceans (fresh and frozen)....  Includes all crustacean species.
                                     Examples include but are not
                                     limited to shrimp, crab, lobster,
                                     and crayfish.
Molluscan shellfish, bivalves       Includes all species of bivalve
 (fresh and frozen) \5\.             mollusks. Examples include, but are
                                     not limited to, oysters, clams, and
                                     mussels. Does not include scallop
                                     adductor muscle. Raw bivalve
                                     molluscan shellfish that are (1)
                                     covered by the requirements of the
                                     National Shellfish Sanitation
                                     Program; (2) subject to the
                                     requirements of 21 CFR part 123,
                                     subpart C, and 21 CFR 1240.60; or
                                     (3) covered by a final equivalence
                                     determination by FDA for raw
                                     bivalve molluscan shellfish are
                                     exempt from the requirements of the
                                     rule under Sec.   1.1305(f).
Ready-to-eat deli salads            Includes all types of refrigerated
 (refrigerated).                     ready-to-eat deli salads. Examples
                                     include, but are not limited to,
                                     egg salad, potato salad, pasta
                                     salad, and seafood salad. Does not
                                     include meat salads.
------------------------------------------------------------------------
\1\ ``Hard cheese'' includes hard cheeses as defined in 21 CFR 133.150,
  colby cheese as defined in 21 CFR 133.118 and caciocavallo siciliano
  as defined in 21 CFR 133.111. Examples of hard cheese include, but are
  not limited to, cheddar, romano, and parmesan.
\2\ For a more comprehensive list, see Chapter 3 of the Fish and Fishery
  Products Hazards and Controls Guidance at https://www.fda.gov/media/80637/download 80637/download.
\3\ Data for catfish were excluded from the Risk-Ranking Model because
  Siluriformes fish (such as catfish) are primarily regulated by the
  U.S. Department of Agriculture.
\4\ ``Smoked finfish'' refers to a finfish product that meets the
  definition of a smoked or smoke-flavored fishery product in 21 CFR
  123.3(s).
\5\ Under 21 CFR 123.3(h), molluscan shellfish means any edible species
  of fresh or frozen oysters, clams, mussels, or scallops, or edible
  portions of such species, except when the product consists entirely of
  the shucked adductor muscle.

    We received several comments on the RRM-FT, the designation of
foods on the FTL, and whether certain foods should or should not be
included on the FTL. We respond to these comments in the following
paragraphs.
1. Risk-Ranking Model for Food Tracing
    (Comment 1) Several comments express general support for the RRM-FT
methodology and the process FDA used to develop the FTL, as well as for
our solicitation of stakeholder input. The comments maintain that the
methodology is grounded in science and the process (including peer
reviews) was rigorous, resulting in a targeted list of foods on the
FTL. Conversely, other comments assert that the FTL fails to include
key FSMA requirements and that the RRM-FT approach is not consistent
with the goal or the statutory factors in section 204(d)(2)(A) of FSMA.
These comments assert that the RRM-FT differs significantly from some
of the FSMA requirements by adding criteria not in the statute and
inappropriately merging multiple statutory factors into one Model
criterion.
    (Response 1) We appreciate the support for the RRM-FT and disagree
with the assertions that it does not align with the statutory factors
or that it differs from the FSMA requirements. As discussed in the
Response to External Peer Review--Model Review (Ref. 9), subject matter
experts (SMEs) reviewed the types of concerns raised in the comments
when developing the draft RRM-FT, and peer reviewers generally agreed
that the seven criteria we adopted were appropriately within the bounds
of the FSMA-mandated factors.
    (Comment 2) One comment claims that the RRM-FT methodology and the
weighting used were not developed according to best practices for a
multicriteria model, and the necessary expertise was not available to
develop the Model appropriately. The comment maintains that the RRM-FT
uses ``an additive weighted approach'' that is not appropriate when the
model criteria are not preferentially independent because it would
likely lead to some double counting of information.
    (Response 2) We disagree with this comment. The results of the RRM-
FT are founded on well-constructed criteria and the best available
data. FDA addressed the issues raised by the comment during the peer
review process (Ref. 9). As described in the final version of the RRM-
FT Methodological Approach Report (Ref. 10), we recognize that mutual
independence of criteria is desirable in a multicriteria-based model
such as the RRM-FT. Within the constraints of the FSMA-mandated
factors, we acknowledge that there are some correlations among the
seven criteria or overlaps of data and information used in scoring, but
we have taken steps to minimize potential overlaps. Most importantly,
in cases where criteria are correlated, the RRM-FT defines them to
represent separate aspects of value (of the data and information) to
help ensure that the criteria represent independent preferences in
ranking (see Methodological Approach Report, section 5.5 (Ref. 10)).
The RRM-FT Methodological Approach Report and the peer review-model
review report provide further explanation on how the RRM-FT
operationalizes the seven criteria to minimize potential overlaps. FDA
relied on the expertise of SMEs both within and outside of the Agency
to develop the RRM-FT.
    In developing the RRM-FT, we reviewed a number of available risk
tools, including some developed by FDA and others from the published
literature, including qualitative, semi-quantitative, and quantitative
methods. We directly addressed the criteria independence issue by
consulting with the project advisory group and multiple external expert
panels and by considering comments and suggestions provided by peer
reviewers.
    (Comment 3) Many comments suggest that data used in the RRM-FT
should be timely and reflect current food safety practices adopted by
the industry. A few comments express support for using a 20-year
timeframe (with appropriate weighting based on the year) for data for
outbreaks and recalls and suggest that data older than 20 years not be
used. Some comments express concern that the 20-year timeframe used in
the RRM-FT is too long and suggest use of a shorter timeframe, such as
10 years, to reflect current industry practices. Whether comments
prefer the use of 10 or 20 years, their concerns about older data are
that it may not represent the current state of the industry because of
advancements in science and food safety management, including the
implementation of the produce safety regulation and the regulation on
preventive controls for human food promulgated under FSMA. Furthermore,
the comments assert that because industry usually attempts to address
food safety problems and adopt enhanced food safety practices and
mitigations to prevent recurrence of outbreaks, the use of older data
may misrepresent risk. A few comments express support for the data
weighting method in the RRM-FT, in which a weight of 0.4, 0.7, or 1 is
applied

depending on the age of the data, but they request clarification as to
whether we will always use the most recent 20 years of data and whether
we will continue to use the same data weighting method in future
updates of the Model.
    (Response 3) We concur that data used in the RRM-FT should be
timely and agree with the comment suggesting that a 20-year timeframe
for outbreak and recall data is appropriate, while giving lower weight
to (down-weighting) the older data. The RRM-FT incorporates a rolling
data window in which the most recent 20-year data is used for scoring
Criterion 1 (Frequency of Outbreaks and Occurrence of Illnesses),
Criterion 7 (Cost of Illness), and Criterion 3 (Likelihood of
Contamination), and within the 20-year timeframe, we down-weight older
data. We believe a 20-year timeframe with down-weighting for older data
provides an appropriate time window and scoring method to accurately
capture the history of outbreaks and contamination associated with a
commodity.
    Criterion 5 (Manufacturing Process Contamination Probability and
Industry-Wide Intervention) in the RRM-FT considers the current state
of industry-wide interventions applied to each commodity-hazard pair.
We acknowledge that industry may make concerted efforts to address food
safety problems such as in response to outbreaks, and that food safety
management practices may improve because of the implementation of
regulations such as those for produce safety or preventive controls for
human food, and these efforts are accounted for in the RRM-FT through
the scoring of Criterion 5. Furthermore, to the extent that industry-
wide preventive controls and interventions reduce food safety risk, the
reduction in risk would also be reflected in the scoring, such as when
the number of recent outbreaks (not down-weighted) is declining
compared to older outbreaks, which would be down-weighted.
    (Comment 4) Many comments state the RRM-FT criteria should be
weighted differently, with more emphasis given to foods with validated
preventive controls and less to epidemiological data. Specifically,
some comments claim that the RRM-FT does not give sufficient weight to
the three factors specified by Congress in FSMA section 204(d)(2)(A)
that are related to contamination and production and processing
activities, i.e., factors (ii) (the likelihood that a particular food
has a high potential risk for microbiological or chemical contamination
or would support the growth of pathogenic microorganisms due to the
nature of the food or the processes used to produce such food), (iii)
(the point in the manufacturing process of the food where contamination
is most likely to occur), and (iv) (the likelihood of contamination and
steps taken during the manufacturing process to reduce the possibility
of contamination). According to the comments, the RRM-FT gives too much
weight to the other three FSMA factors, which are related to outbreaks
or are epidemiological in nature. The comments assert that because the
RRM-FT has five criteria to represent the three factors that are
epidemiological in nature, this places too much emphasis on those
factors in comparison to the two criteria that represent the factors
related to the nature of food and manufacturing activities. The
comments maintain that the over-emphasis of epidemiology in the Model
contradicts Congressional intent and results in certain RACs such as
leafy greens, herbs, tomatoes, cucumbers, peppers, and melons being
deemed risky when, in the view of the comments, industry and the
scientific community have greater food safety concerns about further
processing of fresh produce such as fresh-cut fruits and vegetables
(e.g., because of a greater potential for contamination and for
pathogen growth).
    Conversely, other comments maintain that the Model puts too much
weight on poor processing conditions rather than on inherent risk. The
comments recommend that we weight criteria so that when a food goes
through a validated kill step or other preventive control (including
hurdle technology), the food is not on the FTL. Similarly, some
comments ask FDA to weight Criterion 5 most heavily and not give too
much weight to Criterion 6 (Consumption), maintaining that if there are
strong industry interventions, the amount consumed is less relevant.
Finally, some comments claim the sensitivity analysis in the RRM-FT is
very limited and that we have not provided sufficient information to
justify equal weighting of the criteria in the Model or the impact of
such equal weighting on the ranking.
    (Response 4) We do not agree with these comments concerning the
appropriate weighting of the statutory risk factors, and the comments
have not provided data to support their recommendations. As indicated
in the RRM-FT Methodological Approach Report (Ref. 10), the RRM-FT uses
the FSMA statutory factors to define the seven criteria used in the
Model, and FDA considered different criteria weighting schemes in the
approach that was peer reviewed. Peer reviewers generally agreed the
Model's seven criteria were appropriate, and there was no general
consensus for use of a different weighting scheme other than equal
weighting of the criteria (Ref. 9). Therefore, we decided to weight the
seven criteria equally in the RRM-FT. With regard to the comments
requesting acknowledgment of the importance of a kill step in risk
reduction, we agree and, as discussed in Section V.E.5 of this
document, Sec.  1.1305(d) of the final rule sets forth exemptions and
partial exemptions for FTL foods that receive or will receive a kill
step.
    (Comment 5) Several comments suggest that FDA consider relevant
data representative of the inherent food safety risk, including data
relevant to intrinsic characteristics of the food (e.g., pH,
application of a validated kill step) and outbreak data from credible
sources (both State and Federal Agencies). The comments assert that it
is not appropriate to use outbreak data and other information from
isolated events or problems specific to a particular facility or
consumer misuse of the food, such as data from the Reportable Food
Registry (RFR), because this information concerns facility-specific
incidents that do not reflect overall risks to public health. The
comments also suggest that FDA should have a scientific basis for
including any food on the FTL.
    (Response 5) The RRM-FT provides the scientific basis for the
designation of the foods on the FTL. As described in the RRM-FT
Methodological Approach Report (Ref. 10), the RRM-FT uses data and
information on the intrinsic characteristics of the food and considers
information on validated control measures in risk scoring. The RRM-FT
uses the FDA Coordinated Outbreak Response and Evaluation (CORE)
outbreak dataset (Ref. 11) that includes the CDC outbreak data for
outbreaks in which the outbreak investigation demonstrated an
association with FDA-regulated products. In addition, for outbreaks
involving Vibrio spp. and marine and plant biotoxins, the Model uses
data from CDC's National Outbreak Reporting System (NORS). To the
extent that State agencies and other health departments report their
foodborne illness outbreaks involving microbial and chemical hazards to
the NORS, outbreaks relevant to FDA-regulated human foods have been
considered in the RRM-FT. To apply the factors specified in FSMA
section 204(d)(2)(A), it is necessary to consider both the
characteristics of foods and hazards. In the RRM-FT, we classify FDA-
regulated human foods into 47 commodity categories. Within each
commodity

category, we identify food commodities and associated known or
reasonably foreseeable hazards, i.e., commodity-hazard pairs, using
outbreak data, contamination data, and other information from multiple
sources (Ref. 10). The RRM-FT uses RFR data as a source for scoring
Criterion 3 only when sampling data are not available. When RFR data
are used in the RRM-FT, these data are aggregated, e.g., RFR reports
from 2009 to 2019 are attributed to a commodity-hazard pair (a specific
hazard in a specific food such as Shiga toxin-producing Escherichia
coli O157 (STEC O157) in leafy greens), which minimizes the potential
issue raised in the comments about overemphasis of facility-specific
problems.
    (Comment 6) Several comments state that the FTL should exclude
foods that, according to the comments, are ``not inherently
dangerous.'' Many comments maintain that fresh produce commodities have
varying degrees of food safety risk; furthermore, the comments assert
that fresh produce itself is not inherently risky and that risks are
introduced by food production conditions and processing activities.
These comments maintain that the risk of contamination is much greater
with fresh-cut produce than intact RACs and that covering unprocessed
produce under the food traceability rule will not improve public
health. Several comments suggest that we factor production methods
(e.g., controlled environment vs. field environments for growing
produce) and growing conditions for RACs into the RRM-FT, or that the
designation of foods on the list be specific to where the food was
produced. One comment states that the likelihood of contamination for
fresh produce varies greatly because growing conditions vary greatly
across farms and regions. The comment provides contrasting examples of
fresh produce sourced from protected high tunnels irrigated with well
water vs. from open fields irrigated with water from a canal near
concentrated animal feeding operations. According to the comment, the
risk of a fresh produce commodity (e.g., leafy greens) is related to
the latter type of growing environment and conditions. Therefore, the
comment maintains that FDA should not require all leafy greens to meet
the same traceability requirements because this would not be science-
based or consistent with requirements in FSMA. Another comment asserts
that, compared to field-grown leafy greens, those produced under
controlled environments have a significantly lower risk of causing
foodborne illness because of different risk factors (including minimal
exposure to animals, potable water irrigation through root systems,
minimal impacts from weather events, and other control measures). The
comment suggests that such ``controlled environment-produced leafy
greens'' should be given different consideration in the RRM-FT than
other leafy greens.
    (Response 6) We disagree with these comments, and the comments do
not provide scientific data to support their assertions. As previously
stated, the RRM-FT scores commodity-hazard pairs according to data and
information relevant for seven criteria that account for the factors
specified in FSMA section 204(d)(2)(A). As discussed in the RRM-FT
Methodological Approach Report (Ref. 10), the RRM-FT criteria are
related not only to the characteristics of the food but also to the
production and manufacturing processes at the commodity level. For
example, we evaluate the impact of fresh-cut processing by first
identifying a variety of commodities under the Produce--RAC commodity
category, and a variety of commodities under the Produce--Fresh Cut
commodity category; for each of the commodities, we then identify known
or reasonably foreseeable hazards, i.e., commodity-hazard pairs for the
commodities of Leafy Greens and Leafy Greens (Fresh-cut). Thus, the
methodology accommodates on-farm production practices by identifying
and evaluating hazards introduced on-farm (e.g., STEC O157 in Leafy
Greens), and it accommodates processing activities by identifying and
evaluating hazards introduced in a processing facility (e.g., Listeria
monocytogenes (L. monocytogenes) in Leafy Greens (Fresh-cut)). The
Model then scores each commodity-hazard pair using data and information
relevant to the seven RRM-FT criteria. For example, the impacts of
production conditions and processing activities are reflected, on an
industry-wide basis, in the data used to score Criterion 3 (Likelihood
of Contamination) and the expert judgment used to score Criterion 5
(Manufacturing Process Contamination Probability and Industry-Wide
Intervention). As such, the Model does consider production and
manufacturing risks, as well as other aspects of risks such as the
potential for the food to support growth of a pathogen (if present).
    We agree with the comments that not all fresh produce is the same.
Therefore, the Model identifies approximately two dozen fresh produce
commodities based on the nature of the food and evaluates each of them
separately, e.g., Leafy Greens, Melons, Tomatoes, Stem Vegetables (see
Ref. 10, Table A-2). In the Model, the identification of commodity-
hazard pairs is based on available data and information, e.g., foods
and hazards associated with outbreaks and illnesses and detection of
hazards in foods. The Model does not rank fresh produce at a more
granular level than at the commodity level. Regardless of production
practices (e.g., field-grown vs. controlled environment), fresh produce
within the same commodity group typically share similar characteristics
in the potential for the food to support pathogen growth, and many
contamination risk factors in controlled environments are similar to
those found in traditional agriculture (Ref. 12). Moreover, we are not
aware of data that warrant a separate evaluation based on production
practices, and data are not available to evaluate commodity-hazard
pairs at that level of granularity for the various criteria in the
Model.
    (Comment 7) Several comments maintain that the RRM-FT
inappropriately grouped foods of different natures. According to the
comments, FDA's approach to risk ranking is problematic because it
groups different types of commodities together without consideration of
the variety in each commodity, and, the comment claims, the risk of the
commodity (e.g., melons, leafy greens) varies depending on the variety
(e.g., watermelon vs. cantaloupe, spinach vs. lettuce). Several
comments state that there are no data to suggest certain fresh herbs
(e.g., fresh bay leaf, makrut lime leaf, curry leaf, rosemary leaf)
present any significant risk to human health or to support
identification of many tropical fruits and leafy greens as high-risk
foods. One comment asserts that while foods within a category may share
similar characteristics in production and processing, the RRM-FT's
analysis of a broad food category cannot adequately consider all the
criteria because some criteria are specific to varieties, not
commodities (e.g., food safety technologies and innovations are usually
developed for particular foods, not commodity groups). The comments
suggest that we conduct individual analyses for particular foods and
revise the FTL accordingly.
    (Response 7) The RRM-FT considers the nature of the food through a
categorization scheme that classifies FDA-regulated foods into 47
commodity categories. Furthermore, within each commodity category, the
RRM-FT identifies individual commodities. In total, the RRM-FT
identifies more than 200 commodities (see Ref. 10, Table A-2).

    The Model does not rank commodities such as fresh produce at a more
granular level than at the commodity level. We are not aware of
scientific evidence that warrants a separate evaluation based on the
varieties within a fresh produce commodity. Moreover, data on
individual foods, such as specific varietals, are sparse and
inconsistent across the variety of foods in the Model and on the FTL.
For the purposes of the FTL, we determined that the appropriate level
of granularity is at the level of ``commodity,'' e.g., ``tomatoes
(fresh)'' rather than ``Roma tomatoes'' or ``cherry tomatoes.'' Food
items within the same ``commodity'' designation generally have similar
characteristics, associated hazards, and production and supply chain
practices and conditions, and peer review for the RRM-FT supported this
approach (Ref. 13). Further, data used to assess components of the
Model (e.g., outbreak and illness data, likelihood of contamination,
degree to which product supports growth, consumption, annual cost of
illness) are available and adequate at the ``commodity'' level of
granularity.
    (Comment 8) A few comments assert that the RRM-FT does not
adequately represent FSMA section 204(d)(2)(A) factors (iii) and (iv)
(i.e., ``the point in the manufacturing process of the food where
contamination is most likely to occur'' and ``the likelihood of
contamination and steps taken during the manufacturing process to
reduce the possibility of contamination'') and that the Model does not
appropriately reflect differences in production systems and practices.
According to the comments, the RRM-FT uses one criterion (Criterion 5:
Manufacturing Process Contamination Probability and Industry-wide
Intervention) to represent the two FSMA factors, which minimizes their
impact on risk ranking, especially if there is a validated kill step
for pathogens in the manufacturing process. The comments suggest that
we consider more broadly the point in the overall supply chain where
contamination is most likely to occur and include data to represent
differences in potential contamination associated with different
production, manufacturing, and handling processes and practices. The
comments request that we revise the RRM-FT and the FTL to address their
concerns and provide the public with an opportunity to comment on the
revisions.
    (Response 8) We decline to revise the RRM-FT and to solicit
additional public comment before issuing the final rule. Regarding FSMA
section 204(d)(2)(A) factors (iii) and (iv), these are incorporated
into Criterion 5 of the RRM-FT (Manufacturing Process Contamination
Probability and Industry-wide Intervention) as well as through the
identification of commodity-hazard pairs under the broad range of
commodity categories of FDA-regulated human foods. The commodities and
the commodity categories (see Table A-1 in the RRM-FT Methodological
Approach Report (Ref. 10)) represent a broad range of foods at
different points in the supply chain with differences in production,
manufacturing, and handling processes and practices. As discussed in
the Response to External Peer Review--Model Review (Ref. 9), subject
matter experts reviewed and addressed the types of concerns raised in
the comments during the development of the draft RRM-FT, and peer
reviewers generally agreed that the seven criteria we adopted were
appropriately within the bounds of the FSMA-mandated factors, including
the representation of FSMA factors (iii) and (iv) in the Model.
    (Comment 9) Many comments assert that fresh produce from smaller-
scale farms with relatively short supply chains (sometimes just a few
miles) have lower risk than produce grown on larger farms, shipped long
distance, or transformed without a kill step and shipped long distance.
The comments maintain that locally grown commodities on the FTL, such
as tomatoes, leafy greens, peppers, and cucumbers, do not have a
greater risk than fresh crops not on the FTL. Some comments also assert
that it is not scientifically sound to group locally grown and non-
locally grown produce into one commodity in the RRM-FT because supply
chain conditions and complexity vary between the two, so the food
safety risk varies. The comments express concerns that such broad
grouping will hurt the local food system, drive up the price of food,
and limit the availability of fresh produce without reducing the risk
of foodborne illness. Similarly, several comments claim the scoring of
Criterion 5 in the RRM-FT is subjective, subject to change over time,
and might not adequately represent small farms or local and regional
food systems (LRFS). According to the comments, the scoring of
Criterion 5, which is based on expert elicitations with several expert
panels, reflects outcomes rather than root causes. One comment
maintains that the size and type of production system and the length of
supply chain are among the root causes of foodborne illness from fresh
produce, but these factors are not adequately considered in the Model.
Comments also note that the Criterion 5 score could change when
industry improves production and manufacturing processes to better
manage risk, which could affect both large and small operations. The
comments suggest FDA obtain and use qualitative data that represent the
scale and diversity of small, local farms and food businesses serving
LRFS supply chains for scoring Criterion 5 and for use otherwise in the
Model.
    (Response 9) We do not agree that locally produced foods are
inherently less risky than non-locally produced foods, and the comments
do not provide scientific data to support their assertions. The Model
does not differentiate locally grown fresh produce because how near to
the point of sale the produce was grown does not change the
characteristics of the food (e.g., the potential for supporting
pathogen growth) or the potential for on-farm contamination. The RRM-FT
considers customary shelf life of fresh produce in scoring the
potential for growth at a temperature at which the commodity (locally
grown or not) is intended to be held and stored. While locally grown
produce might be purchased and consumed within a time period shorter
than that for non-locally grown produce, data are not available to show
the potential for pathogen growth is sufficiently different between the
two to result in a different score in Criterion 4 (Growth Potential,
with Consideration of Shelf Life). Fresh produce commodities on the
FTL, including locally grown produce, score higher than fresh produce
commodities not on the FTL based on data relevant to the seven criteria
in the RRM-FT. While we do not agree that locally grown FTL food is
less risky than non-locally grown food, we understand that small
operations may be particularly burdened by the provisions of the rule.
We also understand that full traceability records may not be necessary
when a consumer or RFE purchases food directly from a farm. Therefore,
the final rule provides exemptions from some or all of the provisions
of subpart S for certain smaller operations and in certain short supply
chain situations, as discussed in sections V.E.2 and V.E.3,
respectively, of this document.
    With regard to the scoring of Criterion 5, FDA scores the seven
criteria in the Model based on available data, both quantitative and
qualitative. If quantitative data are not available for a certain
criterion, the criterion is scored based on qualitative data. The RRM-
FT relies on qualitative information from consultations with SMEs,
including external expert panels, to score Criterion 5. The scoring of
Criterion 5 is based on

the SMEs' assessments of each of the commodity-hazard pairs based on
the status of industry-wide interventions as of 2019 (Ref. 10). The
SMEs' assessment is based on the entire industry sector, including
consideration of farms and operations of all sizes and scale
collectively. It is not feasible to assess a commodity specific to the
scale of a farm or LRFS supply chain because data for the seven
criteria are unavailable at that level of granularity. In the peer
review process, we specifically inquired about the adequacy of the
expert elicitation process used to obtain qualitative data and address
data gaps in the RRM-FT (Ref. 13), and there was general consensus
among the peer reviewers that the process was adequate for the purpose.
Changes in industry-wide interventions over time will be assessed as
the data in the Model are updated in the future (see Response 488 about
updating the Model).
    (Comment 10) Several comments state that certain ingredients (e.g.,
peanut butter) could be considered low risk but, because of their
incorporation into many diverse foods, the magnitude of the impact if a
contamination issue arises becomes greater, especially if no kill step
is applied.
    (Response 10) We agree that ingredients that are incorporated into
many different foods have the potential to introduce widespread
contamination. In the Model, we consider this possibility by including
multi-ingredient foods, identifying and evaluating multi-ingredient
commodity-hazard pairs based on data (e.g., from outbreaks, recalls,
and surveillance studies) and expert knowledge.
    (Comment 11) One comment maintains that the RRM-FT does not provide
justification for the criteria scores of 1, 3, and 9. According to the
comment, these values can inappropriately inflate risk scores, and it
is unusual to have the same value for a high, medium, and low score for
all criteria when the ranges of values in each of the criteria are
different. The comment also maintains that a multi-criteria model
should include the elicitation of the value function, but the RRM-FT
does not show that such an elicitation was done. The comment asserts
that the RRM-FT uses arbitrary scoring bins of 0, 1, 3, and 9, leading
to the top bin score of 9 being 9 times as bad as the bin score of 1,
and FDA does not justify this difference. Another comment suggests that
FDA use more evenly distributed scoring bins, claiming the 0-1-3-9
binning approach could over-inflate the criterion score, especially for
Criterion 1 (Frequency of Outbreaks and Occurrence of Illnesses),
Criterion 4 (Growth Potential, with Consideration of Shelf Life), and
Criterion 5 (Manufacturing Process Contamination Probability and
Industry-wide Intervention).
    (Response 11) In developing the RRM-FT, we evaluated multiple value
functions, including using an evenly distributed scale (1-2-3-4) and
essentially a logarithmic scale (0-1-3-9) for scoring Model criteria.
The scoring and binning methodology chosen was based on extensive
consultations with external and internal SMEs as well as peer review.
Given the intended use of the Model, an essentially logarithmic scale
was recommended by multiple external panels in the expert elicitation
process and the peer reviewers in the Model review panel. A
justification of the chosen methodology is provided in the RRM-FT
Methodological Approach Report (Ref. 10). The rationale behind using
the scoring scale of 0-1-3-9 is that risk is not necessarily operating
on a linear scale. Furthermore, using the 0-1-3-9 scale facilitates a
greater degree of differentiation between higher- and lower-ranked
food-hazard pairs, which is useful for informing the designation of the
FTL. The RRM-FT methodology does not consider a criterion score of 9 to
be 9 times ``as bad as'' a score of 1. Rather, as is the case with all
multi-criteria decision analysis models, results from the RRM-FT
provide a risk ranking of alternatives but do not directly quantify
risk to the consumer (e.g., the probability of illnesses), which
requires a different methodology such as a quantitative risk
assessment. The RRM-FT methodology appropriately gives the same
criterion score to a range of data points that fall into the same
scoring bin because, for its intended purpose, the RRM-FT does not
attempt to quantify risk on a continuous risk basis, as would be done
in a quantitative risk assessment.
    (Comment 12) One comment claims the RRM-FT uses a method to
determine the contribution of multiple hazards in which the total risk
score for a food is determined by summing the risk scores of the food-
hazard pairs associated with the food. According to the comment, this
method makes a food associated with multiple hazards more likely to be
designated high-risk because it would have a higher score. Furthermore,
the comment suggests that FDA consider other factors (such as
processing controls) so that a food is not more likely to be designated
high-risk simply because it is associated with multiple hazards.
    (Response 12) The RRM-FT does not use the summing method stated by
the comment; instead, the Model uses an aggregation method that
involves exponential transformation, summing, and log transformation
taking into consideration the risk scores for all food-hazard pairs
under the food. This aggregation method is not sensitive to the number
of hazards associated with the commodity, but rather the risk score for
the commodity is driven by the highest-scored commodity-hazard pair(s).
With regard to considering processing controls, the RRM-FT considers
processing controls when scoring Criterion 5, which accounts for steps
taken to reduce contamination and industry-wide interventions.
    (Comment 13) Several comments claim that Criterion 6 (Consumption)
in the RRM-FT does not align with FSMA section 204(d)(2)(A)(v), which
directs FDA to consider the ``likelihood that consuming a particular
food will result in a foodborne illness due to contamination of the
food. . . .'' The comments maintain that section 204(d)(2)(A)(v) was
intended to be more about consumer handling of the food, such as
whether there is temperature abuse, whether the food is cooked
properly, and amount consumed. The comments maintain that the
consumption criterion in the RRM-FT (which focuses on frequency and
amount of consumption) may skew risk ranking, especially for popular
foods. One comment acknowledges that higher consumption of a food could
cause an outbreak with greater public health consequences but argues
that is not what Congress directed FDA to evaluate.
    (Response 13) We disagree with the comments and believe that
Criterion 6 in the Model appropriately reflects FSMA factor (v) because
consumption patterns affect the likelihood that consuming a particular
food will result in a foodborne illness when the food is contaminated.
Inclusion of the consumption criterion in the RRM-FT is based on
extensive consultation with SMEs including external expert panels, and
it has been subject to peer review (Refs. 9 and 13). Additionally,
consumption is a standard component of a risk assessment, as described
in the Food and Agriculture Organization (FAO)/World Health
Organization (WHO) microbiological risk assessment guidance for food
(Ref. 14). FDA defines Criterion 6 by using two data indicators,
consumption rate and amount consumed (Ref. 10). When contaminated,
products that are consumed frequently, in large amount, or both are
more likely to cause widespread outbreaks. We think that FSMA factor
(ii) (``the likelihood that a particular food has a high potential risk
for microbiological or chemical

contamination or would support the growth of pathogenic microorganisms
due to the nature of the food or the processes used to produce such
food'') is the factor that relates more directly to the consequence
from the potential for temperature abuse during the customary shelf
life of the food, and we therefore considered that issue in the scoring
of Criterion 4 (Growth Potential, with Consideration of Shelf Life) for
the commodity-hazard pair. The RRM-FT does not consider consumer
cooking because the commodities in the RRM-FT are defined as foods
available for purchase by consumers.
    (Comment 14) One comment asserts that the Model does not identify
or explain a ``cut-off'' risk score above which foods are on the FTL,
which makes it impossible to evaluate the impacts of the Model.
    (Response 14) The RRM-FT methodology is designed to evaluate what
the risk score is, not what risk score is used to designate a line
above which foods are on the FTL. The final version of the Designation
of the FTL Memorandum (Ref. 15) describes this cut-off score and
explains how FDA uses results from the Model to determine whether a
food is on the FTL.
    (Comment 15) One comment asserts that the Model attributes fresh-
cut leafy green outbreaks to both fresh-cut and RAC leafy green
commodities. According to the comment, this inappropriately inflates
the risk scores for both categories, particularly in the case of RAC
products where it is often unknown if the contamination occurred after
processing, and results in the RRM-FT scoring RAC leafy greens as
higher risk than fresh-cut leafy greens. The comment asserts that this
contradicts industry understanding and well-known science that fresh-
cut produce by its very nature presents a higher risk than the same
produce in RAC form.
    (Response 15) The RRM-FT does not attribute outbreaks associated
with fresh-cut leafy greens to both fresh-cut and RAC leafy green
commodities. The Model does not ``double count'' outbreaks; each
outbreak is attributed to a single commodity-hazard pair, e.g., either
the RAC or the fresh-cut product, depending on the source of the
outbreak. FDA scores Criterion 1 (Frequency of Outbreaks and Occurrence
of Illnesses) in the RRM-FT based on the Agency's determination of the
source implicated in an outbreak, i.e., whether it was determined to be
a food vehicle (such as fresh salsa) or a contaminated ingredient used
in the vehicle (such as contaminated tomatoes used in the fresh salsa)
(Ref. 10). We attribute the number of illnesses and outbreaks to a
commodity-hazard pair according to information on the contaminated
ingredient (i.e., the source of the contamination), not to the food
vehicle implicated (if it is different from the contaminated
ingredient), when both the contaminated ingredient and the food vehicle
were identified in the outbreak investigation. For example, if fresh
salsa was implicated in a foodborne illness outbreak but tomatoes were
identified as the contaminated ingredient, the outbreak would be
attributed to tomatoes and not fresh salsa.
    We disagree with the comment's assertion that the RRM-FT
methodology contradicts the current scientific understanding of the
route of pathogen contamination in fresh produce. We considered public
comments on the 2014 draft methodological approach in the development
of the RRM-FT (Ref. 4), and we had the methodological approach peer
reviewed in 2016 (Refs. 9 and 13). Based on the peer-reviewed approach,
we updated the underlying data, where major data sources for scoring in
the Model were updated to 2019 or the latest available data (Ref. 10).
Consequently, our approach to outbreak attribution is based on the best
available information on the source of contamination, which remains
consistent with current scientific understanding. For example, the fact
that the commodity-hazard pair risk score is higher for the pair
``Leafy greens--STEC O157'' than for the pair ``Leafy greens (fresh-
cut)--STEC O157'' (risk score of 430 vs. 310) (Ref. 10) reflects the
fact that STEC O157 is more likely to originate in RAC leafy greens
(but can sometimes remain in fresh-cut leafy greens after processing).
However, for a hazard associated with leafy greens for which the
processing environment is a typical route of contamination (such as L.
monocytogenes), the risk score is higher for ``Leafy greens (fresh-
cut)--L. monocytogenes'' than ``Leafy greens--L. monocytogenes'' (risk
score of 370 vs. 330). The RRM-FT systematically scores relevant
commodity-hazard pairs for RAC leafy greens and fresh-cut leafy greens.
The Model then calculates a risk score for each commodity using an
appropriate aggregation method (Ref. 10), where the risk score for the
commodity is driven by the risk score for the highest-scored commodity-
hazard pair(s); this results in a commodity risk score that is higher
for RAC leafy greens than fresh-cut leafy greens.
    (Comment 16) One comment suggests that we consider the wide
variations in shelf life and pathogen growth potential among dairy
products. As an example, the comment compares a pathogen like L.
monocytogenes in a soft Hispanic-style cheese, which has strong growth
potential, to any pathogen in ice cream, which has effectively zero
growth potential. The comment maintains that having two indicators for
scoring Criterion 4 (i.e., using a scoring matrix of Growth Potential
and Shelf Life) is problematic and may skew the criterion score for a
commodity as a whole compared to the scores for individual foods. For
example, the comment maintains that it does not seem accurate to have
the same Criterion 4 score for a dairy product with a short shelf life/
strong growth potential as for a dairy product with a moderate shelf
life/moderate growth potential.
    (Response 16) We agree that it is important to consider the
variations in pathogen growth potential. Consistent with the comment's
suggestion, results from the Model show a wide range of Criterion 4
scores among commodity-hazard pairs for dairy commodities. To determine
the score for Criterion 4, we use a single indicator based on the
potential that a food would support the growth of pathogenic
microorganisms due to the nature of the food, and the extent of growth
as affected by the customary shelf life of the food and the temperature
at which the food is intended to be held and stored. This reflects a
revision that we made to the draft approach, taking into consideration
comments we had received from the public and from peer reviews of the
RRM-FT (Refs. 9, 13). The commenter incorrectly stated that Criterion 4
in the 2020 RRM-FT Methodological Approach Report (Ref. 4) used for the
proposed rule included two indicators. We changed the Criterion 4
scoring definition to one indicator in the revised Model (2020) in
response to comments peer reviewers and stakeholders had made on the
2014 draft. As a result, the revised Model uses only one indicator to
score Criterion 4, which is ``Growth potential, with consideration of
shelf life,'' instead of using ``Growth potential/shelf life,'' which
was evaluated as two separate indicators in the draft approach. The
scoring definition for Criterion 4 includes the amount of growth
(log10 increase) given customary shelf life. As described in
the RRM-FT Methodological Approach Report (Ref. 10), the revised
definition allows us to appropriately apply data from growth studies
and predictive microbiology databases, as well as avoid potentially
skewing the criterion score if two indicators were used.

    (Comment 17) One comment expresses concern about treating ``Dairy''
as one group in the RRM-FT and asserts that foods selected in the RRM-
FT are not representative of the wide diversity of the dairy industry.
The comment states that the dairy industry makes a wide variety of
products, including ice cream, yogurt and cultured dairy products,
butter, hard cheeses, soft cheeses, sour cream, cottage cheese, dips,
canned sweetened condensed and evaporated milks, pasteurized flavored
and unflavored fluid milks, dried milk, whey powders, raw milk, and raw
milk products. The comment asserts that each of these products has
unique intrinsic characteristics and that the manufacturing process of
each product may involve a unique combination of processing steps. The
comment further maintains that it is not appropriate to combine
pasteurized and unpasteurized dairy products into a single category
because some dairy products are virtually risk-free, while raw milk and
raw milk products are inherently risky. For support, the comment cites
CDC data indicating that over 70 percent of outbreaks associated with
dairy products are attributed to raw milk and raw milk cheeses.
Therefore, the comment suggests that we revise the dairy food
classification considering intrinsic properties (e.g., pH and
aw) and potential for pathogen growth in the product, choose
representative dairy foods that reflect the diversity of the industry,
and ensure that risks from raw milk and raw milk products do not affect
the risk scores of other dairy products. The comment specifically
recommends that we separate dairy products into three categories--
cheese, ice cream, and milk--and further divide the cheese category
into four subcategories: soft ripened cheese, semi-soft cheese, hard
cheese, and other cheese. The comment also suggests that we amend the
food facility registration classification scheme by adding a new
category for yogurt and other fermented milks and cultured dairy
products because of their unique intrinsic properties. Finally, the
comment urges us to put raw milk and raw milk products in a stand-alone
category named ``Raw Milk for Consumption and Raw Milk Products.''
    (Response 17) We do not believe it is necessary to make the
revisions suggested by the comment. We agree that each of the dairy
commodities has its unique food characteristics and manufacturing
processes. In fact, the RRM-FT considers such unique characteristics
and processes, as well as most of the dairy products suggested by the
comment, in scoring each of the dairy commodities and associated
commodity-hazard pairs.
    The RRM-FT does not treat ``Dairy'' as one group but instead
includes six separate commodity categories for dairy products (see Ref.
10, Table A-1), several of which contain multiple specific commodities
(see Ref. 10, Table A-2). The Model identifies as separate commodities
different types of cheeses (fresh cheese, soft-ripened cheese, and hard
cheese) made from pasteurized milk. Furthermore, cheeses made from raw
milk are classified into their own commodities separate from cheeses
made from pasteurized milk. Ultimately the RRM-FT identifies and
evaluates 21 individual dairy commodities (see Ref. 10, Table A-2).
    The concerns expressed in the comment do not reflect the handling
of the dairy commodity categories in the Model (Ref. 10). The RRM-FT
uses data relevant to seven criteria for each commodity and associated
commodity-hazard pairs to generate risk scores, taking into
consideration the intrinsic characteristics of the food (such as the
low pH of yogurt) in scoring Criterion 4 (Growth Potential, with
Consideration of Shelf Life), among other data. The RRM-FT does
consider ``Dairy--Fermented dairy products other than cheese'' as a
stand-alone commodity category that includes two separate commodities
(Yogurt and Cultured Products (excluding yogurt)) and associated
commodity-hazard pairs. Amending the food facility registration scheme
to add a new category for yogurt as the comment suggests is beyond the
scope of this rulemaking. Additionally, while the RRM-FT does not
include a raw milk commodity because FDA prohibits the sale of raw milk
in interstate commerce, the RRM-FT evaluates raw milk in two separate
commodities, one for hard cheeses made from unpasteurized milk and one
for cheeses other than hard made from unpasteurized milk.
    (Comment 18) One comment asserts that FDA did not include or
consider costs of complying with the FTL traceability rule in Criterion
7 (Cost of Illness) of the RRM-FT and recommends that we include these
costs.
    (Response 18) The RRM-FT includes public health risk criteria as
specified by FSMA section 204(d)(2)(A). Criterion 7 of the RRM-FT is
defined as the cost of illness for the commodity-hazard pair;
therefore, it is not appropriate to include in this criterion non-
public health economic impacts such as the cost of complying with the
rule. FDA considers the costs and benefits associated with the rule in
the Final Regulatory Impact Analysis (FRIA) (Ref. 16).
    (Comment 19) One comment requests clarification on how FDA will
address changes in consumer habits. Specifically, for a food that is
not on the FTL because FDA has determined that the food is rarely
consumed raw, the comment requests clarification on whether covered
entities are responsible for knowing that consumer habits have changed
such that the product is no longer rarely consumed raw or if the FTL
remains the same until FDA changes it. The comment also asks if we will
indicate that we are planning to update the FTL due to changes in
consumer habits.
    (Response 19) The FTL will remain the same until we change it. The
process for changing the FTL, which includes advance notice and an
opportunity for the public to provide comment, is discussed in Section
V.S of this document.
    It is possible for a food to be part of a commodity that is on the
FTL but to nonetheless be exempt under Sec.  1.1305(e) of the final
rule because it is listed as rarely consumed raw in Sec.  112.2(a)(1)
(21 CFR 112.2(a)(1)). For example, collards fall within the commodity
``Leafy Greens,'' but they are exempt from the subpart S requirements
because they are listed as rarely consumed raw in Sec.  112.2(a)(1).
Because any changes to the rarely consumed raw list in Sec.
112.2(a)(1) would have to be made through notice and comment
rulemaking, firms would receive notice that the rarely consumed raw
list might change and would have an opportunity to provide comments on
the potential change.
    (Comment 20) Some comments ask FDA to clarify the growing and
production processes that were evaluated and used to place foods on the
FTL. The comments also request that we clarify, if processes and
practices change, how that type of information will be used to support
inclusion or removal of foods from the FTL.
    (Response 20) The growing and production processes that we
evaluated and used to place foods on the FTL are described in the RRM-
FT Methodological Approach Report (Ref. 10), specifically in section 3
of the report (``Identification of Food-Hazard Pairs''), where we
describe the food classification scheme, and in the description of
Criterion 5 (Manufacturing Process Contamination Probability and
Industry-wide Intervention), which evaluates the possibility of hazard
introduction

during manufacturing and the ability to control contamination with
interventions through growing and production practices and processes
throughout the supply chain. We will consider changes in industry
processes and practices when we update the Model (see Response 488).
    (Comment 21) Several comments ask that we make an interactive model
tool available for stakeholders to test hypothetical changes to the
scores for each criterion in the RRM-FT. Additionally, the comments ask
that we make the data inputs and risk scores for all foods evaluated
(not just those on the FTL) available to the public to increase
transparency and help stakeholders with future business decisions.
Comments also request that we provide the commodity category level
analyses as well as the analyses for individual commodities in the
commodity category. One comment that requests revisions to the RRM-FT
further suggests that we conduct a pilot test with an interactive
version of the revised RRM-FT to demonstrate to stakeholders how the
scores are determined for the criteria and how that results in food
being placed on the FTL. This comment suggests that stakeholders be
given an opportunity to comment on the revised Model and the
demonstration, which the comment maintains would give credibility to
the Model and promote public acceptance.
    (Response 21) We have already made public a substantial amount of
information that allows stakeholders to analyze and interact with
information relating to the RRM-FT, including testing hypothetical
changes to the Model scores. For example, we provided a web-based tool
(Ref. 17), the RRM-FT Methodological Approach Report (Ref. 10), and a
full list of references for the data and information used in the Model
(see link to references in Ref. 17). These materials provide the
details of the methods on which the analyses are based (including
examples) with all the information stakeholders need to reproduce such
analyses. The tool also provides the total score for each of the
commodities on the FTL as well as the criteria scores for the
commodity-hazard pairs that make up each commodity on the FTL. In
response to comments, we are considering making public the scores for
all the foods evaluated in the Model, including those food/hazard pairs
not included on the FTL. The Designation of the FTL Memorandum (Ref.
15) describes key aspects of how FDA uses the RRM-FT to designate the
FTL.
    With regard to the suggested pilot of the Model and additional
opportunities for stakeholder comment, we have provided stakeholders
with opportunities to comment throughout the development of the FTL. As
previously stated, we published our draft approach for developing a
risk-ranking model for public comment in 2014. We then refined the
approach, taking into consideration the public comments received. Two
separate external peer-review panels reviewed a draft model and the
data used to generate risk scores with the Model, respectively.
Concurrently with issuance of the proposed rule, we made available a
revised model and updated the data, taking into consideration comments
from the peer reviews. Additionally, we provided opportunities for
stakeholders to obtain clarity on how the scores are determined for the
criteria and which foods would be placed on the FTL during three public
meetings. When we develop a new FTL in the future, we intend to publish
a proposed updated FTL in the Federal Register for public input, review
comments from the public, and publish a final updated FTL in the
Federal Register. We believe this will provide stakeholders sufficient
opportunity to provide input on any potential changes to the FTL.
    (Comment 22) Several comments suggest that FDA use the RRM-FT to
evaluate the risk of any new food, such as a multi-ingredient food that
contains an ingredient on the FTL (FTL ingredient). The comments
maintain that the dose-response curve should be considered in each
instance and the risk of a multi-ingredient food that contains an FTL
food may change depending on the ability of the relevant microbial
pathogen(s) to survive and grow in the new food. The comments
acknowledge practical challenges in a potentially enormous number of
new foods that contain FTL ingredients that would each need to be
evaluated. The comments suggest that, if FDA does not have the
resources to evaluate all the new foods, it should apply a threshold to
the amount of an FTL food that needs to be in a multi-ingredient food
for the new food to be on the FTL, or help industry use the RRM-FT
methodology to self-assess the risk of a new food to determine whether
subpart S would apply.
    (Response 22) We decline to use the RRM-FT to make individual
evaluations of each multi-ingredient food that contains an FTL food.
This would not be practical, nor is it necessary. Elsewhere in the
final rule, we are providing additional clarity on which foods
containing FTL foods as ingredients are on the FTL (see Response 27).
For example, for a food that is specified on the FTL as being fresh or
fresh-cut, if the nature of the FTL food has not changed in the new
multi-ingredient food containing the FTL food as an ingredient (e.g.,
bagged salad mix containing lettuce, smoothie containing fresh
cantaloupe, sandwich containing fresh-cut tomato), the risk of the FTL
food used as an ingredient in the new food is not expected to decrease.
In fact, in some cases, the ability of bacterial pathogens to grow
could be greater in the fresh FTL food when it is cut or sliced and
included in the new multi-ingredient food.
    With respect to the dose-response curve, we acknowledge there might
be different levels of risk of illness when a different amount of an
FTL food is consumed. However, there is no generalizable evidence with
regard to risk of illness from a specific amount of the FTL foods that
would enable us to set a threshold amount for FTL foods used as
ingredients in other foods, as suggested by the comments.
    (Comment 23) One comment maintains that in developing the RRM-FT,
FDA should have ensured that risk managers agreed the Model criteria
were relevant to the decision for designating the FTL. The comment
maintains that FDA did not report work done in this area.
    (Response 23) We disagree with the comment. FSMA section
204(d)(2)(A) establishes six factors for assessing risk of foods and
designating the FTL that are represented by the criteria in the RRM-FT.
The RRM-FT Methodological Approach Report (Ref. 10) describes the
iterative process for developing the RRM-FT. This process included
extensive and iterative consultations with an FDA Project Advisory
Group, consisting of members from FDA's Center for Food Safety and
Applied Nutrition, Office of Foods and Veterinary Medicine, Office of
Food Policy and Response, Office of Policy, Legislation and
International Affairs, Center for Veterinary Medicine, and Office of
Regulatory Affairs, as well as the CDC (Ref. 10). The Project Advisory
Group provided both technical and policy perspectives in the
development of the Model. Furthermore, as discussed above in Response
2, during the development of the Model we consulted multiple external
expert panels and considered comments and suggestions provided by peer
reviewers.
    (Comment 24) Several comments oppose using customer reviews as data
for scoring in the RRM-FT. The comments voice concern with FDA's
expressed interest in using artificial intelligence to mine non-
traditional data

sources, specifically customer online reviews, as part of our efforts
to gather additional data to support risk modeling and inspection
prioritization. These comments do not believe customer online reviews
will meaningfully contribute to data gathering.
    (Response 24) The RRM-FT does not use customer reviews in scoring
because the Model only includes data relevant to seven criteria based
on the factors specified in section 204(d)(2)(A) of FSMA (Ref. 10),
including the number of reported outbreaks and illnesses for commodity-
hazard pairs. However, under FDA's New Era of Smarter Food Safety
initiative, we will continue to explore ways to utilize non-traditional
data sources and the use of artificial intelligence to protect the U.S.
food supply. Additional information on this effort can be found in
FDA's Blueprint for New Era of Smarter Food Safety (Ref. 18).
    (Comment 25) Several comments assert that FDA does not appear to
have considered comments they submitted on FDA's draft methodological
approach in 2014. Specifically, the comments maintain that some issues
they had submitted in 2014 remain not adequately addressed in the RRM-
FT (2020 version), including the following claims: (1) the RRM-FT is
not aligned with FSMA section 204(d)(2)(A) because it combines factors
(iii) and (iv) into one criterion (Criterion 5--Manufacturing Process
Contamination Probability and Industry-wide Intervention) and the
Model's consumption criterion does not align with FSMA; (2) foods
selected are not representative of the diversity of the dairy industry;
(3) having two indicators for Criterion 4 (i.e., using a scoring matrix
of Growth Potential and Shelf Life) is problematic; (4) use of summing
as an aggregation method (i.e., summing risk scores for commodity-
hazard pairs to calculate a risk score for the commodity) is not
appropriate; and (5) the RRM-FT does not provide a cut-off score for
foods on the FTL.
    (Response 25) We considered each of these issues that were
submitted in comments on the draft methodological approach in 2014 in
the iterative process we used to develop and refine the RRM-FT. As
previously stated, the iterative approach involved consulting with the
RRM-FT Project Advisory Group and multiple external expert panels, and
considering comments and suggestions provided by peer reviewers. As
previously discussed, we have responded to these issues in this final
rule (see Response 26 for discussion of the RRM-FT alignment with
statutory factors in FSMA section 204(d)(2)(A); Response 17 for
discussion of foods selected in the Dairy group; Response 16 for
discussion of the indicators for Criterion 4; Response 12 for
discussion of the aggregation method used for risk scores in the RRM-
FT; and Response 14 for discussion of the cut-off score for foods on
the FTL).
2. Designation of Foods on the FTL
a. General
    (Comment 26) Some comments are supportive of the designation of the
foods on the FTL. Conversely, other comments raise concerns with how we
determine which foods are on the FTL and suggest our approach was not
what Congress intended.
    (Response 26) We appreciate the comments that are supportive of the
FTL. In section 204(d)(1) of FSMA, Congress directed us to establish
recordkeeping requirements for certain designated foods that would be
additional to the traceability recordkeeping requirements in section
414 of the FD&C Act and the subpart J regulations. In section 204(d)(2)
of FSMA, Congress directed us to consider specific factors in
determining for which foods additional traceability recordkeeping
requirements are needed. To determine which foods should be included on
the FTL, we developed the RRM-FT based on the factors Congress
identified in section 204(d)(2)(A) of FSMA. The Model considers FDA-
regulated human foods, identifies commodities available for purchase at
retail, and for each commodity identifies associated known or
reasonably foreseeable hazards. The Model scores commodity-hazard pairs
according to data and information relevant to the seven criteria
described in the RRM-FT Methodological Approach Report (Ref. 10), which
are based on the factors Congress identified in section 204(d)(2)(A) of
FSMA. A commodity was included on the FTL if its risk score, aggregated
across all associated hazards, was 330 or higher in the Model or if the
evidence of outbreaks and illnesses and cost of illness scores for one
or more associated commodity hazard pairs was ``strong'' (Ref. 15).
This approach is science-based and reflects the intent of Congress in
identifying the foods for which additional traceability records are
necessary.
b. FTL Foods as Ingredients
    (Comment 27) Some comments support our proposal to include on the
FTL both foods specifically listed as well as foods that contain a
listed food as an ingredient. However, many comments oppose this
approach. Some comments claim that FDA exceeded its statutory authority
by expanding the FTL beyond ``particular'' foods (as specified in
section 204(d)(2)(A)(i), (ii), (v), and (vi) of FSMA). Some comments
assert that the proposed approach would impose a burden on industry to
identify every food that contains an FTL food as an ingredient without
a corresponding public health benefit. Other comments maintain that
this approach would lead to confusion and a lack of clarity for the
food industry and increase the burden, particularly on retailers and
distributors. One comment asserts that this approach would reduce
consumption of produce because multi-ingredient foods would be
formulated to avoid including foods on the FTL, such as certain produce
items. Some comments provide examples of products for which we should
not require additional recordkeeping for traceability, such as frozen
pizza with cheese, granola bars with dried fruit, herbed bread, and
quiches that use different types of peppers. Many comments ask that we
exempt foods containing FTL foods as ingredients unless they are
otherwise a listed food, such as a deli salad containing tomatoes, or
to specifically list on the FTL certain multi-ingredient foods that
should be covered under the final rule, such as bagged salads. Some
comments recommend that the final rule apply only to foods on the FTL
and foods containing listed foods as ingredients that will be consumed
without a kill step.
    (Response 27) We are clarifying our approach to the FTL in response
to the comments. For several of the commodities on the FTL, we have
clarified which version of the commodity is on the FTL and therefore
covered by the final rule. For example, if a commodity is specified as
``fresh'' on the FTL, then only the fresh version of the commodity is
covered by the final rule. If such a commodity is used in its fresh
form as part of a multi-ingredient food, then the multi-ingredient food
would be covered under the final rule. For example, fresh lettuce used
in a bagged salad mix, fresh cantaloupe in a commercially prepared
smoothie, or a sandwich containing a fresh tomato would be covered, but
a frozen pizza with a spinach topping or trail mix with dried papaya
would not be covered. We believe this approach is appropriate because
the risk of the fresh FTL food would not be diminished just because it
is used as an ingredient in a multi-ingredient food, if no kill step is
applied or the FTL food is not otherwise changed, for example by drying
or

freezing, such that it is no longer on the FTL. Further, the multi-
ingredient food may be a key signal in an outbreak investigation that
ultimately leads to identification of the contaminated ingredient. For
example, we may receive a signal of fresh salsa in an outbreak
investigation, and after further investigation be able to attribute the
outbreak to the fresh tomatoes in the salsa. This example demonstrates
not only why it is important to have the multi-ingredient food covered
by the rule (because it is causing illness and serves as a key signal),
but also why a commodity such as fresh salsa might not independently
appear on the list if it is associated with outbreaks that are not
attributed to it in our outbreak database because they are found to
have been caused by an ingredient such as fresh tomatoes (see Response
15). Therefore, we believe it is appropriately protective of public
health for the subpart S requirements to apply to multi-ingredient
foods with FTL foods as ingredients, provided the FTL food remains in
the same form (e.g., ``fresh'') that is specified on the FTL. We do not
think Congress's use of the word ``particular'' in section
204(d)(2)(A)(i), (ii), (v), and (vi) of FSMA precludes this approach.
    For foods on the FTL that are not designated as ``fresh,'' if those
FTL foods are used as ingredients in a multi-ingredient food and no
kill step is applied or the FTL food is not otherwise changed such that
it is no longer on the FTL, then the multi-ingredient food would be
covered by the final rule. For example, peanut butter in a sandwich
cracker for which no kill step is applied (to either the peanut butter
or the peanut butter sandwich cracker) will be covered by the rule. As
discussed in Response 75, the commodities on the FTL related to finfish
and seafood include both the fresh and frozen forms of those products.