Agency Information Collection Activities; Proposed Collection; Comment Request; Focused Mitigation Strategies To Protect Food Against Intentional Adulteration, 6009-6011 [2019-03197]
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Federal Register / Vol. 84, No. 37 / Monday, February 25, 2019 / Notices
nonclinical testing and clinical
considerations. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Implanted Brain-Computer Interface
Devices for Patients with Paralysis or
Amputation—Nonclinical Testing and
Clinical Considerations’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 1500045 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations
and guidance. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in the
following FDA regulations and guidance
have been approved by OMB as listed in
the following table:
OMB control
No.
21 CFR part or guidance
Topic
812 ..............................................................................................
‘‘Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug
Administration Staff’’.
801 ..............................................................................................
820 ..............................................................................................
Investigational Device Exemption ..............................................
Q-submissions ...........................................................................
0910–0078
0910–0756
Medical Device Labeling Regulations ........................................
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.
Protection of Human Subjects: Informed Consent; Institutional
Review Boards.
0910–0485
0910–0073
50, 56 ..........................................................................................
Dated: February 14, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–03144 Filed 2–22–19; 8:45 am]
BILLING CODE 4164–01–P
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:
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
VerDate Sep<11>2014
16:22 Feb 22, 2019
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
Notice.
SUMMARY:
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6009
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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
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0910–0755
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
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6010
Federal Register / Vol. 84, No. 37 / Monday, February 25, 2019 / Notices
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/201523389.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
VerDate Sep<11>2014
16:22 Feb 22, 2019
Jkt 247001
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:
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• 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 (§ 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
(§ 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 (§ 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
(§ 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
(§ 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 (§ 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
(§ 121.150);
• conduct a reanalysis of the food
defense plan (§ 121.157);
• ensure that all individuals who
perform required food defense activities
are qualified to perform their assigned
duties (§ 121.4); and
• establish and maintain certain
records, including the written food
defense plan (vulnerability assessment,
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Federal Register / Vol. 84, No. 37 / Monday, February 25, 2019 / Notices
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
(§§ 121.301 to 121.330).
Description of Respondents: The
respondents to this information
6011
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
Number of
respondents
Activity; 21 CFR section
Exemption for food from very small businesses;
§ 121.5.
1 There
Number of
responses per
respondent
18,080
Total annual
responses
1
Average burden per
response
18,080
Total hours
0.5 (30 minutes) .....
9,040
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 × 18,080 firms).
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity; 21 CFR section
Total annual
records
Average burden per
recordkeeping
Total hours
Food Defense Plan; § 121.126 ....................................
Actionable Process Steps; § 121.130 ..........................
Mitigation Strategies; § 121.135(b) ..............................
Monitoring
Corrective
Actions,
Verification;
§ 121.140(a), § 121.145(a)(1).
Training; § 121.160 ......................................................
Records; § 121.305, § 121.310, ...................................
3,247
9,759
9,759
9,759
1
1
1
1
3,247
9,759
9,759
9,759
23 ...........................
20 ...........................
20 ...........................
175 .........................
74,681
195,180
195,180
1,707,825
367,203
9,759
1
1
367,203
9,759
0.67 (40 minutes) ...
10 ...........................
244,802
97,590
Total ......................................................................
........................
........................
........................
................................
2,515,258
1 There
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Number of
records per
recordkeeper
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 § 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 § 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
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manager incurs a burden of 20 hours for
this activity, as reflected in table 2,
row 2.
Under § 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
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Fmt 4703
Sfmt 9990
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
§ 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
§§ 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
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[[Page 6011]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
