[Federal Register Volume 88, Number 7 (Wednesday, January 11, 2023)]
[Rules and Regulations]
[Pages 1503-1505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00391]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2017-D-5225]


Foreign Supplier Verification Programs for Importers of Food for 
Humans and Animals: 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 or we) is announcing the 
availability of a final guidance entitled ``Foreign Supplier 
Verification Programs for Importers of Food for Humans and Animals: 
Guidance for Industry.'' This guidance document provides our thinking 
on how importers of food for humans and animals can comply with the 
regulation on foreign supplier verification programs (FSVPs) issued on 
November 27, 2015. The guidance announced in this notice finalizes the 
draft guidance of the same title dated January 24, 2018.

DATES: The announcement of guidance is published in the Federal 
Register on January 11, 2023.

ADDRESSES: You may submit comments on any guidance 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

[[Page 1504]]

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-2017-D-5225 for ``Foreign Supplier Verification Programs for 
Importers of Food for Humans and Animals: Guidance for Industry.'' 
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.
    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 draft 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 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Compliance Policy Staff, Office of 
Compliance, Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 27, 2015 (80 FR 74226), we 
issued a final rule adopting a regulation on FSVPs for importers of 
food for humans and animals (FSVP final rule) (see, 21 CFR part 1, 
subpart L). The FSVP final rule implements section 301 of the FDA Food 
Safety Modernization Act (FSMA) (Pub. L. 111-353), which enables the 
Agency to better protect public health by helping to ensure the safety 
and security of the food supply.
    Section 301 of FSMA added section 805 to the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) to require persons who 
import food into the United States to perform risk-based foreign 
supplier verification activities. In addition to directing FDA to issue 
regulations on the content of FSVPs, section 805 of the FD&C Act 
directs FDA to issue guidance to assist importers in developing FSVPs.
    In accordance with section 805 of the FD&C Act, we are announcing 
the availability of a final guidance entitled, ``Foreign Supplier 
Verification Programs for Importers of Food for Humans and Animals: 
Guidance for Industry.'' This guidance provides our thinking on how to 
comply with the FSVP regulation, including, but not limited to, 
requirements to analyze the hazards in food, evaluate a potential 
foreign supplier's performance and the risk posed by a food, and 
determine and conduct appropriate foreign supplier verification 
activities. The guidance also addresses how importers can meet the 
modified FSVP requirements for importers of dietary supplements, very 
small importers, importers of food from certain small foreign 
suppliers, and importers of food from countries whose food safety 
systems we have officially recognized as comparable or determined to be 
equivalent to that of the United States.
    In the Federal Register of January 24, 2018 (83 FR 3443) we made 
available a draft guidance for industry entitled ``Foreign Supplier 
Verification Programs for Importers of Food for Humans and Animals'' 
and gave interested parties an opportunity to submit comments by May 
25, 2018, for us to consider before beginning work on the final version 
of the guidance. We received several comments on the draft guidance and 
those comments were considered as the guidance was finalized. A summary 
of changes includes additional clarification regarding to what foods 
the FSVP regulation applies, what information must be included in the 
FSVP, who may develop and perform FSVP activities, what hazard analysis 
must be conducted, what foreign supplier approval and verification 
activities must be conducted, what requirements apply for importing a 
food for which the hazards will be controlled after importation, how 
FSVP records must be maintained, what FSVP requirements apply for 
imported dietary supplement components, and what FSVP requirements 
apply to very small importers or when importing food for certain small 
foreign suppliers. In addition, editorial changes were made to improve 
clarity. The guidance announced in this notice finalizes the draft 
guidance dated January 24, 2018.
    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 on ``Foreign Supplier Verification Programs for 
Importers of Food for Humans and Animals: Guidance for Industry.'' 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.

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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 21 CFR part 1, subpart L have been approved under OMB 
control number 0910-0752.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/FoodGuidances, 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: January 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00391 Filed 1-10-23; 8:45 am]
BILLING CODE 4164-01-P


