Agency Information Collection Activities; Proposed Collection; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration, 71646-71648 [2021-27285]
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Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Notices
members and 37 shall be nonvoting
members who serve as representatives
of consumer interests and of industry
interests. FDA is publishing separate
documents announcing the Request for
Nominations Notification for Nonvoting
Representatives on certain panels of the
MDAC. Persons nominated for
membership on the panels should have
adequately diversified experience
appropriate to the work of the panel in
such fields as clinical and
administrative medicine, engineering,
biological and physical sciences,
statistics, and other related professions.
The nature of specialized training and
experience necessary to qualify the
nominee as an expert suitable for
appointment may include experience in
medical practice, teaching, and/or
research relevant to the field of activity
of the panel. The current needs for each
panel are listed in table 2. Members will
be invited to serve for terms of up to 4
years.
III. Nomination Procedures
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Any interested person may nominate
one or more qualified individuals for
membership on one or more of the
advisory panels. Self-nominations are
also accepted. Nominations must
include a current, complete re´sume´ or
curriculum vitae for each nominee,
including current business address,
telephone number, and email address if
available and a signed copy of the
Acknowledgement and Consent form
available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must also specify the
advisory panel(s) for which the nominee
is recommended. Nominations must
also acknowledge that the nominee is
aware of the nomination unless selfnominated. FDA will ask potential
candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflict of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: December 13, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–27376 Filed 12–16–21; 8:45 am]
BILLING CODE 4164–01–P
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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.
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.
SUMMARY:
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
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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
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Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Notices
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-201509-18/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, PRAStaff@
fda.hhs.gov.
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
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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 (§ 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 (§ 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
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written explanation of how the
mitigation strategy sufficiently
minimizes or prevents the significant
vulnerability associated with the
actionable process step (§ 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 (§ 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 (§ 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 (§ 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
(§§ 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
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Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Notices
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-toolseducational-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
Activity; 21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Exemption for food from very small
businesses; 21 CFR 121.5 ................
18,080
1
18,080
0.5 (30 minutes)
9,040
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
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), and 121.150(c) ...........
Training; § 121.160 ................................
Records; §§ 121.305 and 121.310 ........
3,247
9,759
9,759
1
1
1
3,247
9,759
9,759
23
20
20
74,681
195,180
195,180
9,759
367,203
9,759
1
1
1
9,759
367,203
9,759
175
0.67 (40 minutes)
10
1,707,825
246,026
97,590
Total ................................................
..............................
..............................
..............................
..............................
2,516,482
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 (§ 121.160).
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Number of
records per
recordkeeper
Number of
recordkeepers
Activity; 21 CFR section
Dated: December 10, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–27285 Filed 12–16–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0241]
Inspection of Injectable Products for
Visible Particulates; Draft Guidance for
Industry; Availability
AGENCY:
ACTION:
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Food and Drug Administration,
HHS.
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The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Inspection of Injectable Products for
Visible Particulates.’’ Visible
particulates in injectable products can
jeopardize patient safety. This draft
guidance addresses the development
and implementation of a holistic, riskbased approach to visible particulate
control that incorporates product
development, manufacturing controls,
visual inspection techniques, particulate
identification, investigation, and
SUMMARY:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section Number of responses per Total annual Average burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemption for food from very small businesses; 21 18,080 1 18,080 0.5 (30 minutes) 9,040
CFR 121.5..........................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual Average burden
Activity; 21 CFR section recordkeepers per recordkeeper records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
