Rule2023-00391
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 11, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 The guidance announced in this notice finalizes the draft guidance of the same title dated January 24, 2018.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 7 (Wednesday, January 11, 2023)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00391]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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draft guidance of the same title dated January 24, 2018.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:
<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
[[Page 1504]]
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-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 <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.
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,
<a href="/cdn-cgi/l/email-protection#d2919481939c91bdbfa2bebbb3bcb1b782bdbebbb1ab92b4b6b3fcbabaa1fcb5bda4"><span class="__cf_email__" data-cfemail="e9aaafbaa8a7aa868499858088878a8cb98685808a90a98f8d88c781819ac78e869f">[email protected]</span></a>.
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.
[[Page 1505]]
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 <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</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: 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 11, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.