[Federal Register Volume 90, Number 150 (Thursday, August 7, 2025)]
[Proposed Rules]
[Pages 38084-38088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-14967]
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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-ZC21
Requirements for Additional Traceability Records for Certain
Foods: Compliance Date Extension
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration is proposing to extend the
compliance date for the final rule, ``Requirements for Additional
Traceability Records for Certain Foods,'' due to concerns about the
amount of time affected entities will need to implement the
requirements of the rule. If finalized, this rule would extend the
compliance date by 30 months from January 20, 2026, to July 20, 2028.
DATES: Either electronic or written comments on the proposed rule must
be submitted by September 8, 2025.
ADDRESSES: You may submit comments on the extension of the compliance
date as follows. Please note that late, untimely filed comments will
not be considered. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
September 8, 2025. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-0053 for ``Requirements for Additional Traceability Records
for Certain Foods: Compliance Date Extension.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents, the
plain language summary of the proposed rule of not more than 100 words
as required by the ``Providing Accountability Through Transparency
Act,'' or the electronic and written/paper comments received, go to
https://www.regulations.gov and insert the docket number, found in
brackets in the heading of this document, into the ``Search'' box and
follow the prompts and/or go to the Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Katherine Vierk, Office of
Surveillance Strategy and Risk Prioritization, Human Foods Program,
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-2122, [email protected], or Alissa Van Wie, Office of
Policy and International Engagement, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-654-7524,
[email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. The Food Traceability Rule
B. Proposed Compliance Date
II. Legal Authority
III. Description of Proposed Rule
IV. Preliminary Economic Analysis of Impacts
V. Analysis of Environmental Impact
VI. Paperwork Reduction Act of 1995
VII. Federalism
VIII. Consultation and Coordination With Indian Tribal Governments
IX. References
I. Background
A. The Food Traceability Rule
The Food and Drug Administration (FDA, the Agency, or we) published
the final rule, ``Requirements for Additional Traceability Records for
Certain Foods'' (87 FR 70910) (Food Traceability Rule), on November 21,
2022. The final rule establishes additional recordkeeping requirements
for persons who
[[Page 38085]]
manufacture, process, pack, or hold foods the Agency has designated for
inclusion on the Food Traceability List (FTL) based on risk. The final
rule requires these entities to maintain records containing information
on critical tracking events in the supply chain for these designated
foods (FTL foods), such as initial 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. 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 FTL foods
identified as causing illness, identify and remove contaminated foods
from the marketplace, and develop mitigation strategies to prevent
future contamination. The final rule had an effective date of January
20, 2023 (60 days after publication of the final rule), and a
compliance date of January 20, 2026 (3 years after the effective date).
The Food Traceability Rule establishes first of its kind national
standards for supply chain traceability from farm to restaurant/retail,
for certain foods based on risk. The rule requires covered entities to
maintain and share specific data elements for FTL foods throughout
supply chains (and with FDA upon request). Entities along a supply
chain must therefore coordinate to share relevant data elements with
subsequent entities in the chain, in a compatible and timely manner.
Since issuing the Food Traceability Rule in 2022, FDA has conducted
extensive stakeholder outreach and education on the rule, in addition
to providing technical assistance, tools, and other resources to assist
industry with implementation. As the regulated industry has worked to
comply with the rule's requirements, entities from across the supply
chain have voiced strong concerns with the initial 3-year
implementation timeframe, stating that they need more time to come into
compliance. Specifically, FDA has heard concerns from industry that
some of the required data elements are not routinely maintained or
shared throughout supply chains, nor are many data systems currently
interoperable throughout supply chains. Industry has also expressed
concerns about the volume of data certain entities in the supply chain
(particularly distributors and retailers) would be required to manage
and challenges with implementing the requirements, including
implementing technology to manage and share the data required.
Technology solutions to assist industry in managing the data are still
being developed, piloted, and evaluated for interoperability. In
addition to the technology challenges, distributors are struggling to
obtain lot codes from their suppliers and experiencing challenges
transmitting them to retailers in a cost-effective manner.
At FDA's request, the Reagan-Udall Foundation for the Food and Drug
Administration (the Foundation) held a series of roundtables over the
summer of 2024 to hear from industry about challenges with
implementation and to help facilitate cross-sector dialogue on
potential solutions. The Foundation issued a summary of feedback
received via the roundtables (Ref. 1). On October 7, 2024, the
Foundation held a public meeting to allow all interested parties to
comment on the feedback gleaned via the roundtables (Ref. 2). The
Foundation also accepted public feedback in writing (Ref. 3).
The feedback received during the roundtables, the public meeting,
and the comments submitted to the Foundation was consistent with what
FDA has been hearing in our other interactions with stakeholders. While
members of industry have expressed a range of views on the challenges
of implementation, very few of them have indicated that they expect to
be able to comply with the Food Traceability Rule by the January 2026
deadline. Even the entities that have been able to devote significant
efforts to compliance have expressed concern about the timeline, in
part because they rely on receiving accurate data from their supply
chain partners, who might not be similarly situated. Moreover, although
the rule does not require electronic recordkeeping or any specific
technologies for records maintenance or supply chain communications,
many industry members using or intending to use electronic data systems
have expressed that they need additional time to develop interoperable
systems for maintaining and sharing traceability data. However, some
consumer group representatives have expressed concern with postponing
implementation of the rule as that would delay the benefits of enhanced
foodborne illness outbreak response.
After carefully considering the public comments, feedback, and
other information gathered since issuing the rule, including from the
Foundation-led efforts, meetings with stakeholders, onsite visits to
covered entities, and other outreach, we have tentatively concluded
that additional time is needed for covered entities to prepare,
including working with their supply chain partners, to help ensure
successful implementation. As stated in the preamble to the final rule
(87 FR 70910 at 71067), because the traceability requirements operate
via a chain of information being maintained and passed forward through
covered entities in the supply chain, if entities in the supply chain
fail to provide required information to their supply chain partners,
the chain would be broken. This means that even if most of the entities
in that particular supply chain were prepared to comply with the rule,
accurate traceability data would still not reach the retail location,
which is where FDA generally must begin its outbreak investigations.
Therefore, the possibility that a significant number of supply chain
entities may have great difficulty coming into compliance by the
current compliance date (January 20, 2026) could substantially diminish
the rule's effectiveness.
We have tentatively concluded that a partial or phased approach to
compliance is not feasible. For the reasons described above, any break
in the chain of information would affect the availability of
traceability data if FDA needed to investigate an outbreak. Moreover,
the complex, interconnected nature of supply chains (with many entities
both sending and receiving required traceability information) makes
extending the compliance date for all covered entities more
operationally feasible than a phased approach that would require
compliance by different types of entities according to different
schedules. Implementing a phased approach would likely require FDA to
describe and classify different steps in the supply chain, which would
be difficult in light of the varied and complicated supply chains that
exist for different types of products. More generally, the focus of
both FDA and industry would be likely to shift to the logistics of
describing and implementing a partial or phased approach to compliance.
We think the public health benefits will be greater if the compliance
date is delayed by 30 months for all of industry, allowing time to
focus on successful implementation of the entire rule throughout the
full supply chain. During the additional time for achieving compliance
that the proposed rule would allow, FDA would continue to support
industry by providing education and other forms of
[[Page 38086]]
engagement to help facilitate the implementation process.
This proposed rule, if finalized as proposed, is expected to be an
Executive Order 14192 deregulatory action.
B. Proposed Compliance Date
The current compliance date for the Food Traceability Rule is
January 20, 2026. FDA is proposing to extend the compliance date
deadline by 30 months to July 20, 2028. This proposed rule is limited
in scope to the Food Traceability Rule compliance date; therefore,
comments should address the proposed compliance date extension. This
compliance date extension does not amend, nor do we intend to amend,
the requirements of the final rule, which will improve food safety and
protect public health.
II. Legal Authority
The Food Traceability Rule was promulgated under section 204(d)(1)
of the FDA Food Safety Modernization Act (FSMA) (21 U.S.C. 2223(d)(1)),
which directed FDA to establish recordkeeping requirements, in addition
to the requirements under section 414 of the FD&C Act (21 U.S.C. 350c)
and FDA regulations in 21 CFR part 1, subpart J (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. The proposed compliance date discussed in this document is
consistent with our authority under section 204(d) of FSMA. We discuss
our legal authority in greater detail in the Final Rule on the
Requirements for Additional Traceability Records for Certain Foods (87
FR 70910 at 70915).
III. Description of the Proposed Rule
This proposed rule proposes to extend the compliance date for the
Food Traceability Rule to address concerns about the amount of time
affected entities will need to implement the requirements. If
finalized, this rule would extend the compliance date by 30 months from
January 20, 2026, to July 20, 2028. FDA anticipates that this
additional time is sufficient for affected entities to implement the
requirements of the Food Traceability Rule--including coordinating with
their supply chain partners as needed--so that the anticipated public
health benefits of the rule can be fully realized.
IV. Preliminary Economic Analysis of Impacts
We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 14192, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 12866 and 13563 direct us to assess all benefits
and costs of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits.
Rules are economically significant under Executive Order 12866 if they
have an annual effect on the economy of $100 million or more; or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities. The Office of Information and Regulatory Affairs (OIRA)
has determined that this proposed rule is an economically significant
regulatory action under section 3(f)(1) of Executive Order 12866.
Executive Order 14192 requires that any new incremental costs
associated with certain significant regulatory actions ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least 10 prior regulations.'' This proposed rule, if
finalized as proposed, is expected to be an Executive Order 14192
deregulatory action.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this proposed rule will reduce the burden on covered
food entities by extending the compliance date of the final rule titled
``Requirements for Additional Traceability Records for Certain Foods''
(the Food Traceability Rule), we propose to certify that the proposed
rule will not have a significant economic impact on a substantial
number of small entities.
The Unfunded Mandates Reform Act of 1995 (Section 202(a)) requires
us to prepare a written statement, which includes estimates of
anticipated impacts, before proposing ``any rule that includes any
Federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any 1 year.''
The current threshold after adjustment for inflation is $187 million,
using the most current (2024) Implicit Price Deflator for the Gross
Domestic Product. This proposed rule would not result in an expenditure
in any year that meets or exceeds this amount.
The benefits of this proposed rule comprise the foregone benefits
associated with extending the compliance date of the Food Traceability
Rule by 2.5 years. We estimate that the present value of the benefits
of the proposed rule over 20 years ranges from -$3,866 million to -$102
million, with a primary estimate of -$1,348 million, using a 3 percent
discount rate and from -$3,408 million to -$90 million, with a primary
estimate of -$1,188 million, using a 7 percent discount rate. The
annualized benefits of the proposed rule range from -$260 million per
year to -$7 million per year, with a primary estimate of -$91 million
per year, using a 3 percent discount rate and from -$322 million per
year to -$8 million per year, with a primary estimate of -$112 million
per year, using a 7 percent discount rate.
The costs of this proposed rule comprise the cost savings
associated with extending the compliance date of the Food Traceability
Rule by 2.5 years. The present value of the costs of the proposed rule
over 20 years ranges from -$3,381 million to -$46 million, with a
primary estimate of -$797 million, using a 3 percent discount rate and
from -$3,258 million to -$56 million, with a primary estimate of -$775
million, using a 7 percent discount rate. Annualized, the costs of the
proposed rule range from -$227 million per year to -$3 million per
year, with a primary estimate of -$54 million per year, using a 3
percent discount rate and from -$308 million per year to -$5 million
per year, with a primary estimate of -$73 million per year, using a 7
percent discount rate.
[[Page 38087]]
Table 1--Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule
[Millions of 2024 dollars]
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Units
Primary Low High ------------------------------------
Category estimate estimate estimate Year Discount Period Notes
dollars rate (%) covered
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Benefits:
Annualized Monetized $millions/year....... -$112 -$322 -$8 2024 7 2024-2043 Foregone benefits associated
-91 -260 -7 2024 3 2024-2043 with extending the compliance
date of the Food Traceability
Rule by 2.5 years.
Annualized Quantified..................... .......... .......... .......... .......... 7 ..........
3 ..........
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Qualitative...............................
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Costs:
Annualized Monetized $millions/year....... -73 -308 -5 2024 7 2024-2043 The costs of this proposed rule
-54 -227 -3 2024 3 2024-2043 comprise the cost savings
associated with extending the
compliance date of the Food
Traceability Rule by 2.5 years.
A portion of foreign cost
savings could be passed on to
domestic consumers. We estimate
that between 0% and 100% of $5
million in annualized costs
savings (7%, 20 years) to
foreign facilities could be
passed on to domestic
consumers. This estimate is not
included in total cost savings
reported in this table.
Annualized Quantified..................... .......... .......... .......... .......... 7 .......... ................................
.......... .......... .......... .......... 3 ..........
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Qualitative............................... Farming-, manufacturing- or cooking-related actions form a necessary link between direct compliance
activities and changing risks of foodborne illness; thus, negative benefits estimates imply cost savings
in this unquantified category.
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Transfers:
Federal Annualized Monetized $millions/ .......... .......... .......... .......... 7 .......... ................................
year. 3
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From/To................................... From:
To:
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Other Annualized Monetized $millions/year..... .......... .......... .......... .......... 7 .......... ................................
3
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From/To................................... From:
To:
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Effects:
State, Local or Tribal Government: None.............................................................................................................
Small Business: We estimate that small, covered food entities will experience a collective cost savings of between $16 million and $22 million
annually..
Wages: None.........................................................................................................................................
Growth: None........................................................................................................................................
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In line with Executive Order 14192, in Table 2 we estimate present
and annualized values of costs, cost savings, and net costs over a
perpetual time horizon. This proposed rule, if finalized as proposed,
is expected to be an Executive Order 14192 deregulatory action. We
estimate that this proposed rule would generate $54 million in
annualized net cost savings at a 7 percent discount rate, discounted
relative to year 2024 over a perpetual time horizon.
Table 2--Executive Order 14192 Summary Table
[Millions of 2024 dollars, discounted over a perpetual time horizon relative to year 2024 at a 7 percent
discount rate]
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Primary estimate Low estimate High estimate
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Present Value of Costs..................................... $0 $0 $0
Present Value of Cost Savings.............................. 771 3,239 56
Present Value of Net Costs................................. -771 -3,239 -56
Annualized Costs........................................... 0 0 0
Annualized Cost Savings.................................... 54 227 4
Annualized Net Costs....................................... -54 -227 -4
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We have developed a Preliminary Economic Analysis of Impacts that
assesses the impacts of the proposed rule. The full preliminary
analysis of economic impacts is available in the docket for this
proposed rule (Ref. 4).
V. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively
[[Page 38088]]
have a significant effect on the human environment. Therefore, neither
an environmental assessment nor an environmental impact statement is
required.
VI. Paperwork Reduction Act of 1995
This proposed rule contains no new or revised collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
VII. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.
VIII. Consultation and Coordination With Indian Tribal Governments
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175.We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.
IX. References
The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. Although FDA
verified the website addresses in this document, please note that
websites are subject to change over time.
1. Reagan-Udall Foundation for the FDA, ``Industry Roundtable Series
on the FSMA Final Rule of Requirements for Additional Traceability
Records for Certain Foods Top-Line Learnings Summary''. September
2024. Available at: https://reaganudall.org/sites/default/files/2024-09/Food%20Traceability%20Top-Line%20Summary%20090424_0.pdf.
2. Reagan-Udall Foundation for the FDA, ``Virtual Public Meeting on
FDA's Final Rule on Requirements for Additional Traceability Records
for Certain Foods''. October 7, 2024. Available at: https://reaganudall.org/news-and-events/events/virtual-public-meeting-fdas-final-rule-requirements-additional-traceability.
3. Reagan-Udall Foundation for the FDA, ``FDA's Final Rule on
Requirements for Additional Traceability Records for Certain Foods
(Written Comments)''. Available at: https://reaganudall.org/sites/default/files/2024-11/FDA%27s%20Final%20Rule%20on%20Requirements%20for%20Additional%20Traceability%20Records%20for%20Certain%20Foods%20%28Written%20Comments%29.pdf.
4. FDA, ``Preliminary Regulatory Impact Analysis, Preliminary
Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act
Analysis for Requirements for Additional Traceability Records for
Certain Foods: Compliance Date Extension,'' 2025. Available at:
https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-14967 Filed 8-6-25; 8:45 am]
BILLING CODE 4164-01-P