
[Federal Register Volume 84, Number 37 (Monday, February 25, 2019)]
[Notices]
[Pages 6009-6011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03197]


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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; Focused 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 or Agency) 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 April 26, 2019.

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 April 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 26, 2019. 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; Focused 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

[[Page 6010]]

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.
     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 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.gpo.gov/fdsys/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.

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: Under the PRA (44 U.S.C. 3501-3520), 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.

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 (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 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,

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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.
    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 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.   121.140(a), Sec.   121.145(a)(1).
Training; Sec.   121.160.....................         367,203               1         367,203  0.67 (40 minutes)........................         244,802
Records; Sec.   121.305, Sec.   121.310,.....           9,759               1           9,759  10.......................................          97,590
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    Total....................................  ..............  ..............  ..............  .........................................       2,515,258
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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 2,515,258 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.  121.60 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 .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.
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: February 19, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03197 Filed 2-22-19; 8:45 am]
 BILLING CODE 4164-01-P


