[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:
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-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.
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:
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
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]]
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.
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?
For those included on export lists, please describe any
challenges you have experienced with exporting human food products
included on the export lists.
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