U.S.-Origin Statements on Seafood; Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "U.S.-Origin Statements on Seafood." The draft guidance, when finalized, will provide examples of U.S.-origin statements in seafood product labeling that FDA would consider to be truthful and not misleading.

Full Text

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<title>Federal Register, Volume 91 Issue 206 (Tuesday, October 27, 2026)</title>
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[Federal Register Volume 91, Number 206 (Tuesday, October 27, 2026)]
[Notices]
[Pages 67588-67589]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21838]



[[Page 67588]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-D-6729]


U.S.-Origin Statements on Seafood; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``U.S.-Origin 
Statements on Seafood.'' The draft guidance, when finalized, will 
provide examples of U.S.-origin statements in seafood product labeling 
that FDA would consider to be truthful and not misleading.

DATES: Submit either electronic or paper comments on the draft guidance 
by December 28, 2026 to ensure that FDA considers your comment on the 
draft guidance before we begin work on the final version of the 
guidance.

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, including 
attachments, submitted electronically 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 want 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 want to be made available to the public, 
submit the comment as a paper submission as specified in ``Paper 
Submissions'' and ``Instructions.''

Paper Submissions

    Submit paper comments by mail/hand delivery/courier to Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852. FDA will post your comment, as 
well as any attachments, except for information submitted, marked, and 
identified as confidential as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2026-D-6729 for ``U.S.-Origin Statements on Seafood.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' be 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 want to be made publicly 
available, submit your comment only as a paper submission. You should 
submit two copies total. In one copy, include the information you claim 
to be confidential with a heading or cover note that states ``THIS 
DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review this 
copy, including the claimed confidential information, in our 
consideration of comments. In the second copy, redact/black out the 
claimed confidential information; this copy will be available for 
public viewing and will be 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 want 
your name and contact information to be made publicly available, 
provide this information on the cover sheet and not in the body of your 
comments and 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 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 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 paper requests for single copies of the draft guidance to 
the Division of Food Labeling/Office of Nutrition and Food Labeling, 
Human Foods Program, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740. Send two self-addressed adhesive labels to help 
that office process your request. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: 
    With regard to the draft guidance: Pedro Cruz, Office of Nutrition 
and Food Labeling, Human Foods Program, Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-2371; or Deirdre 
Jurand, Office of Regulations and International Programs, Human Foods 
Program, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-2378.
    With regard to the proposed collection of information: Chris 
Colburn, Office of Operations, Food and Drug Administration, Three 
White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 
20852, 240-402-2093, <a href="/cdn-cgi/l/email-protection#b1e1e3f0e2c5d0d7d7f1d7d5d09fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="29797b687a5d484f4f694f4d480741415a074e465f">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``U.S.-Origin Statements on Seafood.'' We are issuing the 
draft guidance consistent with our good guidance practices regulation 
(21 CFR 10.115). The draft guidance, when finalized, will represent the 
current thinking of FDA on this topic. It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternate approach if it satisfies the requirements of the applicable 
statutes and regulations.
    In general, FDA-regulated food products may bear truthful and not 
misleading statements, including U.S.-origin statements, in their 
labeling. This draft guidance, when finalized, will provide examples of 
U.S.-origin statements in seafood product labeling that we would 
consider truthful and not misleading.
    As we develop final guidance on this topic, FDA will consider 
comments on costs or cost savings the guidance may generate, as 
relevant for Executive Order 14192.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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

[[Page 67589]]

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 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.

U.S.-Origin Statements on Seafood: Draft Guidance for Industry

OMB Control Number 0910-0381--Revision

    This draft guidance, if finalized, would provide examples of U.S.-
origin statements in seafood product labeling that FDA would consider 
truthful and not misleading. These products include both single-
ingredient seafood and the seafood components of multi-ingredient 
foods. Respondents that choose to use U.S.-origin statements on their 
seafood products should be able to substantiate the statements to show 
that they are truthful and not misleading.
    Description of respondents: Respondents to this information 
collection are manufacturers, packers, and distributors of seafood. 
Respondents are from the private sector (for-profit businesses).
    We estimate the burden of this collection of information as 
follows:

                                                      Table 1--Estimated One-Time Relabeling Burden
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                                                                       Number of
                    Activity                         Number of      disclosures per     Total annual    Average burden    Total hours     Total capital
                                                    respondents        respondent       disclosures     per disclosure                      costs \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Relabel for U.S.-origin statement...............           1,150                  5            5,750                1            5,750       $7,664,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    The burden estimates in Table 1 are based on FDA's institutional 
experience and knowledge of the seafood industry. We assume there are 
two scenarios where seafood products would be relabeled. The first 
scenario would involve a product currently labeled with a U.S.-origin 
statement, where the respondent chooses to remove such statement. The 
second scenario would involve a product not currently labeled with a 
U.S.-origin statement, where the respondent chooses to add such 
statement. Both instances involve relabeling. Because these statements 
are voluntary, we do not know how many respondents would make labeling 
changes. For the purpose of this analysis, we estimate that there are 
about 2,300 domestic manufacturers, packers, and distributors of 
seafood. Further, we estimate that approximately half of them (1,150 
firms) would change their labels to either add or remove a U.S.-origin 
statement. We estimate that each firm would change 5 labels with each 
label taking about an hour to revise for an annual third-party 
disclosure burden of 5,750 hours (1,150 firms x 5 labels x 1 hour). 
Based on our experience with other relabeling policies, we estimate 
relabeling each product that respondents choose to relabel would cost 
$1,333 assuming a three-year adoption period. That calculates to an 
annual capital cost of $7,664,750 ($1,333 x 5,750 labels). This is the 
cost of designing revised labels and incorporating them into the 
manufacturing process. We believe that this would be a one-time capital 
cost.
    This estimate also does not include maintaining records to 
substantiate a statement as respondents already maintain records as a 
usual and customary business practice.

III. Electronic Access

    You may obtain the draft guidance at: <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 
websites listed in the previous sentence to find the most current 
version of the guidance.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21838 Filed 10-23-26; 4:15 pm]
BILLING CODE 4164-01-P


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