Document ID: FDA-2021-D-0563-0001
Agency: fda
Document Type: Notice
Title: Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier 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
Posted Date: 2022-03-14T04:00Z

[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 [www.gpo.gov]
[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:
     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-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 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 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.

[[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) (https://www.fda.gov/food/guidanceregulation/fsma/ucm334114.htm) (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:
     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.
     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.
     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 https://www.fda.gov/RegulatoryInformation/Guidances/default.htm, 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. 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