[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71646-71648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-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 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

[[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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents 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: 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, 
[email protected].

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:
     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));
     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));
     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));
     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);
     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));
     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));
     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));
     conduct a reanalysis of the food defense plan (21 CFR 
121.157);
     ensure that all individuals who perform required food 
defense activities are qualified to perform their assigned duties (21 
CFR 121.4); and
     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 https://www.fda.gov/food/food-defense/food-defense-tools-educational-materials. 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 https://www.fda.gov/food/food-defense. 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
                                                          ----------------------------------------------------------------------------------------------
    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