[Federal Register Volume 89, Number 217 (Friday, November 8, 2024)]
[Notices]
[Pages 88785-88787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-4776]


Export Lists for Human Food: Request for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) 
invites comment relating to the listing requirements of other countries 
and FDA's approach to facilitating U.S. industry compliance with these 
requirements through the issuance of export certification for human 
food products provided in the form of lists (export lists).

DATES: Submit either electronic or written comments on the request for

[[Page 88786]]

information by January 7, 2025 to ensure that the Agency considers your 
comment.

ADDRESSES: You may submit comments in the following way:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <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-2024-N-4776 for ``Export Lists for Human Food: Request for 
Information.'' 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.
    <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.'' We will review 
this copy, including the claimed confidential information, in our 
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.

FOR FURTHER INFORMATION CONTACT: Peter Fricke, Human Foods Program, 
Office of International Engagement, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2307.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 801(e)(4)(A) of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 381(e)(4)(A)), any person who exports a food, 
drug, animal drug, or device may request that FDA:
    <bullet> certify in writing that the exported food, drug, animal 
drug, or device meets the requirements of section 801(e)(1) or section 
802 of the FD&C Act (21 U.S.C. 382) or
    <bullet> certify in writing that the food, drug, animal drug, or 
device being exported meets the applicable requirements of the FD&C Act 
upon a showing that the food, drug, or device meets the applicable 
requirements of the FD&C Act.
    If we issue a written export certification within 20 days, we may 
then charge a fee up to $175 for each certification (see section 
801(e)(4)(B) of the FD&C Act). The statute also authorizes us to issue 
certifications on a basis and in a form that we determine to be 
appropriate and expressly mentions publicly available listing as a form 
of certification (see section 801(e)(4)(C) of the FD&C Act).
    Regarding export certification for human foods, FDA issues various 
types of export certificates and certification in the form of export 
lists. (For more information on the types of export certificates we 
issue for human foods, see https://www.fda.gov/food/exporting-food-products-united-states/food-export-certificates.) To request inclusion 
on an export list, parties can use our Export Listing Module, which can 
be accessed through our website at https://www.access.fda.gov/. 
Certification in the form of export lists is an intensive process due 
to both the development of a mutually acceptable listing procedure with 
foreign countries and then the maintenance of the export lists. FDA 
provides such certification to help ensure foreign market access for 
U.S. exporters of FDA-regulated food products. FDA export certification 
provides information concerning a product's regulatory status, often 
including information about the establishment in which the product was 
manufactured, packaged, prepared and/or held, based on available 
information at the time FDA issues the certification (including, as 
appropriate, attestations provided by the person seeking the export 
certification). In many cases, foreign governments are seeking official 
assurance that products exported from the United States to their 
countries can be marketed in the United States or that the products 
meet specific U.S. regulations, for example, as applicable, current 
good manufacturing practice regulations. A foreign government may also 
require export certification as part of the process to register or 
import a product into that country.
    FDA does not currently charge firms to be included on export lists 
for human food, but as authorized by the FD&C Act, we are considering 
charging fees for our export list services to offset our costs. As of 
August 2024, we provide certification in the form of export lists that 
cover 19 categories of products for six destinations: Chile, China, the 
European Union, Saudi Arabia, Taiwan, and the United Kingdom.
    To better inform the continuing development of our export list 
program for human foods, we invite public comment on the following:

[[Page 88787]]

    <bullet> There are many different types of establishment listing 
and certification procedures for establishments that produce human food 
products. Please share your experience with other countries' 
establishment listing, certification, and registration requirements.
    <bullet> FDA requires those on export lists to reapply regularly if 
they wish to remain listed. Do reapplicants experience any challenges 
with the renewal process? If you have experienced challenges, how were 
those challenges resolved?
    <bullet> For those included on export lists, please describe any 
challenges you have experienced with exporting human food products 
included on the export lists.
    <bullet> FDA is authorized to collect up to $175 per certification 
for each company and its human food products that FDA certifies through 
inclusion on an export list. For those that would be charged a fee, do 
you have any specific suggestions about how FDA should approach the 
implementation of fees? Please provide details relating to any 
suggestions you might have.

    Dated: November 4, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26040 Filed 11-7-24; 8:45 am]
BILLING CODE 4164-01-P