2024-26040. Export Lists for Human Food: Request for Information

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Department of Health and Human Services

Food and Drug Administration

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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for information.

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 ( print 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 onhttps://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: ( print 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.