Rule2022-05315
Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions; Guidance for Industry; Availability
Primary source
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Published
March 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance for industry entitled "Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions." This guidance states Agency policy regarding enforcement of certain requirements related to supply-chain programs for contract manufacturers/processors, the intentional adulteration regulation, and supplier approval and verification requirements in the Current Good Manufacturing Practice and Preventive Controls Regulations and the Foreign Supplier Verification Programs (FSVP) Regulation.
Full Text
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<title>Federal Register, Volume 87 Issue 49 (Monday, March 14, 2022)</title>
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[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Rules and Regulations]
[Pages 14169-14170]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05315]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 112, 117, 121, and 507
[Docket No. FDA-2021-D-0563]
Current Good Manufacturing Practice and Preventive Controls,
Foreign Supplier Verification Programs, Intentional Adulteration, and
Produce Safety Regulations: Enforcement Policy Regarding Certain
Provisions; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of a final guidance for industry entitled
``Current Good Manufacturing Practice and Preventive Controls, Foreign
Supplier Verification Programs, Intentional Adulteration, and Produce
Safety Regulations: Enforcement Policy Regarding Certain Provisions.''
This guidance states Agency policy regarding enforcement of certain
requirements related to supply-chain programs for contract
manufacturers/processors, the intentional adulteration regulation, and
supplier approval and verification requirements in the Current Good
Manufacturing Practice and Preventive Controls Regulations and the
Foreign Supplier Verification Programs (FSVP) Regulation.
DATES: The announcement of the guidance is published in the Federal
Register on March 14, 2022.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2021-D-0563 for ``Current Good Manufacturing Practice and
Preventive Controls, Foreign Supplier Verification Programs,
Intentional Adulteration, and Produce Safety Regulations: Enforcement
Policy Regarding Certain Provisions.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
[[Page 14170]]
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
For questions relating to CGMP, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food: Jenny Scott, Center for Food Safety
and Applied Nutrition (HFS-300), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-2166.
For questions relating to CGMP, Hazard Analysis, and Risk-Based
Preventive Controls for Food for Animals: Jennifer Erickson, Center for
Veterinary Medicine (HFV-200), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-7382.
For questions relating to Foreign Supplier Verification Programs
for Importers of Food for Humans and Animals: Kevin Kwon, Center for
Food Safety and Applied Nutrition (HFS-600), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 703-785-1125.
For questions relating to Mitigation Strategies to Protect Food
Against Intentional Adulteration: Ryan Newkirk, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-3712.
For questions relating to Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption: Samir Assar,
Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1636.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``Current Good Manufacturing Practice and Preventive Controls,
Foreign Supplier Verification Programs, Intentional Adulteration, and
Produce Safety Regulations: Enforcement Policy Regarding Certain
Provisions.'' We are issuing the guidance consistent with our good
guidance practices regulation (21 CFR 10.115). We are implementing the
guidance without prior public comment because we have determined that
prior public participation is not feasible or appropriate (Sec.
10.115(g)(2)). We made this determination because the guidance presents
a less burdensome policy consistent with the public health. Although
this guidance is immediately in effect, it remains subject to comment
in accordance with FDA's good guidance practices regulation.
This guidance concerns five of the seven foundational rules that we
have established in Title 21 of the Code of Federal Regulations (21
CFR) as part of our implementation of the FDA Food Safety Modernization
Act (Pub. L. 111-353). The five final rules are entitled ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food'' (published in the Federal Register of
September 17, 2015, 80 FR 55908) (part 117); ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Food for Animals'' (published in the Federal Register of
September 17, 2015, 80 FR 51670) (part 507); ``Foreign Supplier
Verification Programs for Importers of Food for Humans and Animals''
(published in the Federal Register of November 27, 2015, 80 FR 74226)
(FSVP regulation); ``Mitigation Strategies to Protect Food Against
Intentional Adulteration'' (published in the Federal Register of May
27, 2016, 81 FR 34166) (IA regulation or part 121); and ``Standards for
the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption'' (published in the Federal Register of November 27, 2015,
80 FR 74354) (<a href="https://www.fda.gov/food/guidanceregulation/fsma/ucm334114.htm">https://www.fda.gov/food/guidanceregulation/fsma/ucm334114.htm</a>) (Produce Safety regulation or part 112).
In the guidance we state that, at this time and based on our
current understanding of the risks, we do not intend to enforce certain
regulatory requirements for certain entities and/or activities covered
by these five rules:
<bullet> Extension of FDA's intent not to take enforcement action
in certain circumstances against a receiving facility that is a
contract manufacturer/processor not in compliance with certain supply-
chain program requirements for food manufactured for a brand owner.
<bullet> Under the intentional adulteration regulation:
[cir] Intent not to enforce the intentional adulteration regulation
requirements for facilities under the preexisting farm-activity related
enforcement policy, and
[cir] Intent not to enforce the requirement for reanalysis in
certain circumstances, for example, when there is a single failure that
is addressed through implementation of corrective action procedures.
<bullet> Intent not to enforce the supplier approval and
verification requirements in parts 117 and 507 and the FSVP regulation
with regard to supplier compliance with requirements that are already
associated with an enforcement discretion policy.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA. 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in part 117 have been approved under OMB control number
0910-0751. The collections of information in part 507 have been
approved under OMB control number 0910-0789. The collections of
information in 21 CFR part 1, subpart L have been approved under OMB
control number 0910-0752. The collections of information in 21 CFR part
121 have been approved under OMB control number 0910-0812. The
collections of information in part 112 have been approved under OMB
control number 0910-0816.
III. Electronic Access
Persons with access to the internet may obtain the document at
either <a href="https://www.fda.gov/RegulatoryInformation/Guidances/default.htm">https://www.fda.gov/RegulatoryInformation/Guidances/default.htm</a>,
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the FDA website listed
in the previous sentence to find the most current version of the
guidance.
Dated: March 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05315 Filed 3-11-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on March 14, 2022.
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