[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Pages 34879-34880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12361]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1425]


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, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 July 8, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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: 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: 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--21 CFR Part 121

OMB Control Number 0910-0812--Extension

    Under the Federal Food, Drug, and Cosmetic Act (FD&C Act) certain 
provisions 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 21 CFR part 121 (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);
     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);
     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);
     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 
(Sec.  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);
     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);
     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);
     conduct a reanalysis of the food defense plan (Sec.  
121.157);
     ensure that all individuals who perform required food 
defense activities are qualified to perform their assigned duties 
(Sec.  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).
    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,

[[Page 34880]]

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 FDA's 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 entitled ``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 entitled ``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.
    In the Federal Register of December 17, 2021 (86 FR 71646), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information 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.

    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        No. of records      Total annual
        Activity; 21 CFR Section           recordkeepers     per recordkeeper       records         Average burden 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.                       9,759                  1              9,759  20.................................            195,180
 121.130.
Mitigation Strategies; Sec.                          9,759                  1              9,759  20.................................            195,180
 121.135(b).
Monitoring Corrective Actions,                       9,759                  1              9,759  175................................          1,707,825
 Verification; Sec.  Sec.   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                    9,759                  1              9,759  10.................................             97,590
 121.310.
                                        ----------------------------------------------------------------------------------------------------------------
    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: June 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12361 Filed 6-7-22; 8:45 am]
BILLING CODE 4164-01-P


