Notice2025-18811
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 90 Issue 186 (Monday, September 29, 2025)</title>
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[Federal Register Volume 90, Number 186 (Monday, September 29, 2025)]
[Notices]
[Pages 46610-46612]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18811]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0339]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Mitigation Strategies
To Protect Food Against Intentional Adulteration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by October 29, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0812. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#356567746641545353755351541b5d5d461b525a43"><span class="__cf_email__" data-cfemail="e0b0b2a1b394818686a0868481ce888893ce878f96">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Mitigation Strategies To Protect Food Against Intentional Adulteration
OMB Control Number 0910-0812--Reinstatement
This information collection supports FDA regulations. Under the
Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA
Food Safety Modernization Act (FSMA), certain provisions have been
established to protect against the intentional adulteration of food.
Section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional
adulteration in the context of facilities that manufacture, process,
pack, or hold food and are required to register under section 415 of
the FD&C Act (21 U.S.C. 350d). Section 419 of the FD&C Act (21 U.S.C.
350h) addresses intentional adulteration in the context of fruits and
vegetables that are raw agricultural commodities. Section 420 of the
FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the
context of high-risk foods and exempts farms except for farms that
produce milk. These provisions are codified at part 121 (21 CFR part
121) and include requirements that an owner, operator, or agent in
charge of a facility must:
<bullet> Prepare and implement a written food defense plan that
includes a vulnerability assessment to identify significant
vulnerabilities and actionable process steps, mitigation strategies,
and procedures for food defense monitoring, corrective actions, and
verification (Sec. 121.126 (21 CFR 121.126));
<bullet> identify any significant vulnerabilities and actionable
process steps by conducting a vulnerability assessment for each type of
food manufactured, processed, packed, or held at the facility using
appropriate methods to evaluate each point, step, or
[[Page 46611]]
procedure in a food operation (Sec. 121.130 (21 CFR 121.130));
<bullet> identify and implement mitigation strategies at each
actionable process step to provide assurances that the significant
vulnerability at each step will be significantly minimized or prevented
and the food manufactured, processed, packed, or held by the facility
will not be adulterated. For each mitigation strategy implemented at
each actionable process step, include a written explanation of how the
mitigation strategy sufficiently minimizes or prevents the significant
vulnerability associated with the actionable process step (Sec.
121.135 (21 CFR 121.135));
<bullet> establish and implement mitigation strategies management
components, as appropriate to ensure the proper implementation of each
such mitigation strategy, taking into account the nature of the
mitigation strategy and its role in the facility's food defense system
(21 CFR 121.138);
<bullet> establish and implement food defense monitoring
procedures, for monitoring the mitigation strategies, as appropriate to
the nature of the mitigation strategy and its role in the facility's
food defense system (Sec. 121.140 (21 CFR 121.140));
<bullet> establish and implement food defense corrective action
procedures that must be taken if mitigation strategies are not properly
implemented, as appropriate to the nature of the actionable process
step and the nature of the mitigation strategy (Sec. 121.145 (21 CFR
121.145));
<bullet> establish and implement specified food defense
verification activities, as appropriate to the nature of the mitigation
strategy and its role in the facility's food defense system (Sec.
121.150 (21 CFR 121.150));
<bullet> conduct a reanalysis of the food defense plan (21 CFR
121.157);
<bullet> ensure that all individuals who perform required food
defense activities are qualified to perform their assigned duties
(Sec. 121.4 (21 CFR 121.4)); and
<bullet> establish and maintain certain records, including the
written food defense plan (vulnerability assessment, mitigation
strategies and procedures for food defense monitoring, corrective
actions, and verification) and documentation related to training of
personnel. All records are subject to certain general recordkeeping and
record retention requirements (Sec. Sec. 121.301 through 121.330 (21
CFR 121.301 through 121.330).
Under the regulations, an owner, operator, or agent in charge of a
facility must prepare, or have prepared, and implement a written food
defense plan, including written identification of actionable process
steps, written mitigation strategies, written procedures for defense
monitoring, written food defense corrective actions, and written food
defense verification procedures.
The purpose of the information collection is to ensure compliance
with the provisions under part 121 related to protecting food from
intentional adulteration. The regulations are intended to address
hazards that may be intentionally introduced to foods, including by
acts of terrorism, with the intent to cause widespread harm to public
health. Under the regulations, domestic and foreign food facilities
that are required to register under the FD&C Act are required to
identify and implement mitigation strategies to significantly minimize
or prevent significant vulnerabilities identified at actionable process
steps in a food operation.
To facilitate the collection of information, FDA offers tools and
educational materials related to protecting food from intentional
adulteration, including the FDA Food Defense Plan Builder, a user-
friendly tool designed to help owners and operators of food facilities
develop a personalized food defense plan, and the Mitigation Strategies
Database, a database for the food industry providing a range of
preventative measures that firms may choose to implement. These and
other informational resources are available at <a href="https://www.fda.gov/food/food-defense/food-defense-tools-educational-materials">https://www.fda.gov/food/food-defense/food-defense-tools-educational-materials</a>. FDA also
offers a small entity compliance guide titled ``Mitigation Strategies
to Protect Food Against Intentional Adulteration'' (August 2017) to
inform domestic and foreign food facilities about compliance with
regulations to protect against intentional adulteration. Further, FDA
developed two draft guidance documents titled ``Mitigation Strategies
to Protect Food Against Intentional Adulteration: Draft Guidance for
Industry'' (March 2019) and ``Supplemental Draft Guidance for Industry:
Mitigation Strategies to Protect Food Against Intentional
Adulteration'' (February 2020). Once finalized, the draft guidance
documents would assist the food industry in developing and implementing
the elements of a food defense plan. These guidance documents are
available at <a href="https://www.fda.gov/food/food-defense">https://www.fda.gov/food/food-defense</a>. All Agency guidance
documents are issued in accordance with our good guidance practice
regulations in 21 CFR 10.115, which provide for public comment at any
time.
Description of Respondents: The respondents to this information
collection are manufacturers, processors, packers, and holders of
retail food products marketed in the United States.
In the Federal Register of July 2, 2025, 90 FR 29025, we published
a 60-day notice requesting public comment on the proposed collection of
information. No comments were received. We retain, therefore, our
estimate of burden for the information collection, which is as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity; 21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Exemption for food from very small 18,080 1 18,080 0.5 (30 minutes)......................... 9,040
businesses; Sec. 121.5.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity; 21 CFR 121 Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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Food Defense Plan; Sec. 121.126............ 3,247 1 3,247 23....................................... 74,681
Actionable Process Steps; Sec. 121.130..... 9,759 1 9,759 20....................................... 195,180
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Mitigation Strategies; Sec. 121.135(b)..... 9,759 1 9,759 20....................................... 195,180
Monitoring, Corrective Actions, Verification; 9,759 1 9,759 175...................................... 1,707,825
Sec. Sec. 121.140(a), 121.145(a)(1),
121.150(b).
Training; Sec. 121.4....................... 367,203 1 367,203 0.67 (40 minutes)........................ 246,026
Records; Sec. Sec. 121.305, 121.310....... 9,759 1 9,759 10....................................... 97,590
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Total.................................... .............. .............. .............. ......................................... 2,516,482
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18811 Filed 9-26-25; 8:45 am]
BILLING CODE 4164-01-P
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