[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Pages 27131-27133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12288]


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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, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the 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: Fax written comments on the collection of information by July 
11, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 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, 
PRAStaff@fda.hhs.gov.

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.

[[Page 27132]]

Focused 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, 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);
     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 to 121.330).
    Description of Respondents: The respondents to this information 
collection are manufacturers of retail food products marketed in the 
United States.
    In the Federal Register of February 25, 2019 (84 FR 6009), we 
published a 60-day notice soliciting public comment of the proposed 
collections of information. Several comments were received in response 
to the notice and are summarized here. Minor comments included general 
support for efforts at protecting food against intentional 
adulteration. Other comments, however, questioned the estimates we 
ascribed to meeting the requirements found in subpart C of the 
applicable regulations: Food defense measures (Sec. Sec.  121.126 
through 121.157 (21 CFR 121.126 through 121.157)). The comments offered 
alternative estimates ranging from few to several hours, and most 
correlated this time to aspects of developing plans, conducting 
vulnerability assessments, and documenting procedures, activities which 
we attribute to the initial review and implementation of new 
regulations. We also note that alternative compliance dates were 
established for the covered entities and have yet to be realized. In 
addition, to assist respondents in complying with the regulation, 
including the information collection requirements, we offer both Agency 
guidance as well as an FDA Food Defense Plan Builder, a user-friendly 
tool designed to help owners and operators of food facilities develop a 
personalized food defense plan, which is currently under development 
with stakeholder input. These and other resources are available from 
our website at https://www.fda.gov. Finally, none of the comments 
appeared to question the applicability of the recordkeeping or the 
associated retention requirements found in part 121, subpart D.
    While we continue to invite comment regarding our burden estimates, 
we note that they reflect what we believe is representative of the 
industry average. This information collection covers numerous 
respondents with varying facility sizes and with differing product 
inventories. As compliance with the regulatory requirements continues 
to take effect, we will continue to evaluate the associated information 
collection burden accordingly. Although we always appreciate feedback 
regarding ways to improve efficiencies associated with our information 
collection activities, we decline to adopt alternative burden estimates 
for the information collection at this time. Rather, we retain the 
current estimates, which are as follows:

[[Page 27133]]



                                                     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. We estimate 18,080 respondents will prepare and 
update relevant files an average of 30 minutes annually, for a total 
annual burden of 9,040 hours (30 minutes x 18,080 firms).

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                  Number of
           Activity; 21 CFR section               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
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) and 121.145(a)(1).
Training; Sec.   121.4.......................         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.

    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 estimated recordkeeping burden 
associated with these activities totals 2,516,482 annual recordkeeping 
burden hours and 409,486 annual recordkeeping responses.
    We estimate an average of 3,247 firms will continue to need to 
create a food defense plan under Sec.  121.126, that a one-time burden 
of 60 hours will be needed to create a plan, and that a burden of 10 
hours will be required to update the plan. We annualize this estimate 
by dividing the total number of burden hours (70) over a 3-year period 
as reflected in table 2, row 1.
    Under Sec.  121.130, each of the estimated 9,759 food production 
facilities will identify and specify actionable process steps for its 
food defense plan. We estimate that an individual at the level of an 
operations manager incurs a burden of 20 hours for this activity, as 
reflected in table 2, row 2.
    Under Sec.  121.135(b), each of the estimated 9,759 food production 
facilities must identify and implement mitigation strategies to provide 
assurances that any significant vulnerability at each step is 
significantly minimized or prevented, ensuring that the food 
manufactured, processed, packed, or held by the facility will not be 
adulterated. We do not specify a specific number or set of mitigation 
strategies to be implemented. Some of the covered facilities are 
already implementing mitigation strategies. We estimate that it 
requires an average of 20 hours per facility to satisfy the 
recordkeeping burden associated with these activities for a total of 
195,180 hours, as reflected in table 2, row 3.
    We estimate that the recordkeeping activities associated with 
monitoring, documenting mitigation strategies, and implementing 
necessary corrective actions require first-line supervisors or others 
responsible for quality control an average of 175 hours for each 
recordkeeping, and that these provisions apply to each of the 9,759 
facilities. This results in a total of 1,707,825 annual burden hours, 
as reflected in table 2, row 4.
    We estimate that recordkeeping activities associated with training 
under Sec.  121.4 total 244,802 annual burden hours, as reflected in 
table 2, row 5. We estimate that there are 1.2 million employees 
working at the regulated facilities and that 30 percent of them 
(367,203) require training. We estimate that the average burden for the 
associated recordkeeping activity is approximately 40 minutes (or 0.67 
hours) per record.
    Finally, we estimate the 9,759 food production facilities will 
fulfill the recordkeeping requirements under Sec. Sec.  121.305 and 
121.310, and that it will require an average of 10 hours per record, as 
reflected in table 2, row 6.

    Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12288 Filed 6-10-19; 8:45 am]
 BILLING CODE 4164-01-P


