Notice2021-27285
Agency Information Collection Activities; Proposed Collection; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration
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Published
December 17, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on collections of information describing mitigation strategies to protect food against intentional adulteration.
Full Text
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<title>Federal Register, Volume 86 Issue 240 (Friday, December 17, 2021)</title>
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[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71646-71648]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27285]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1425]
Agency Information Collection Activities; Proposed Collection;
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, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on collections of information
describing mitigation strategies to protect food against intentional
adulteration.
DATES: Submit either electronic or written comments on the collection
of information by February 15, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 15, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 15, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2013-N-1425 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Mitigation Strategies to Protect
Food Against Intentional Adulteration.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly
[[Page 71647]]
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#f7a7a5b6a483969191b7919396d99f9f84d9909881"><span class="__cf_email__" data-cfemail="a1f1f3e0f2d5c0c7c7e1c7c5c08fc9c9d28fc6ced7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Mitigation Strategies To Protect Food Against Intentional
Adulteration--21 CFR Part 121
OMB Control Number 0910-0812--Extension
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 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 (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
[[Page 71648]]
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.
In an effort to reduce burden and assist respondents, 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.
We estimate the burden of the information collection 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 Total hours
respondents respondent responses response
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Exemption for food from very small businesses; 21 18,080 1 18,080 0.5 (30 minutes) 9,040
CFR 121.5..........................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Certain facilities may qualify for an exemption under the
regulations. Because these facilities must provide documentation upon
request to verify their exempt status, we have characterized this as a
reporting burden.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Number of records Total annual Average burden
Activity; 21 CFR section recordkeepers per recordkeeper records per recordkeeping Total hours
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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
Mitigation Strategies; Sec. 121.135(b)................. 9,759 1 9,759 20 195,180
Monitoring Corrective Actions, Verification; Sec. Sec. 9,759 1 9,759 175 1,707,825
121.140(a), 121.145(a)(1), and 121.150(c)...............
Training; Sec. 121.160................................. 367,203 1 367,203 0.67 (40 minutes) 246,026
Records; Sec. Sec. 121.305 and 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 other than to
increase the burden estimate by 1,224 hours due to a corrected
calculation for the estimate related to training (Sec. 121.160).
Dated: December 10, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27285 Filed 12-16-21; 8:45 am]
BILLING CODE 4164-01-P
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