2024-17781. Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Draft Guidance for Industry; Availability

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Department of Health and Human Services

Food and Drug Administration

1. 21 CFR Chapter I
2. [Docket No. FDA-2024-D-2977]

AGENCY:

Food and Drug Administration, Department of Health and Human Services (HHS).

ACTION:

Notification of availability.

SUMMARY:

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #293 entitled “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.” This draft guidance, when finalized, will communicate FDA's enforcement policy regarding ingredients listed in chapter six of the 2024 Association of American Feed Control Officials (AAFCO) Official Publication (OP) after the expiration of the Agency's memorandum of understanding (MOU) with AAFCO. The current MOU, which expires in October 2024, will not be renewed.

DATES:

Submit either electronic or written comments on the draft guidance by September 9, 2024, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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:

• 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-D-2977 for “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.” 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.” 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 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.

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 guidance to the Policy and Regulations Staff, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Charlotte Conway, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6768, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry #293 entitled “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.” This draft guidance sets forth FDA's proposed policy regarding the marketing of certain unapproved animal food additives, or animal food containing those food additives, in interstate commerce. The draft guidance also describes FDA's proposed policy with respect to animal food labels that identify ingredients by names defined in the AAFCO OP.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the authority to regulate substances used in animal food. Section 201(s) of the FD&C Act (21 U.S.C. 321(s)) defines a food additive, in part, as any substance whose intended use results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food . . . if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety . . . to be safe under the conditions of its intended use. Substances that are “generally recognized as safe” (GRAS) ^[1] for their intended uses in food are not food additives.

Section 409(b) of the FD&C Act (21 U.S.C. 348 (b)) and FDA's implementing regulations at title 21 of the Code of Federal Regulations (21 CFR), part 571, describe the animal food additive petition process and the data and information that must be submitted to FDA as part of an animal food additive petition to support premarket approval. In general, to be legally marketed and used, a food additive must be approved, covered by an FDA regulation, and used as described in the FDA regulation.^[2] Otherwise, the food additive is considered unsafe under section 409(a)(2) of the FD&C Act, and the food additive and any food that bears or contains it is adulterated under section 402(a)(2)(C)(i) of the FD&C Act. Approved food additives for animal food use are found in 21 CFR parts 573 and 579.

FDA has affirmed certain substances as GRAS for their intended use in animal food and these are listed in 21 CFR parts 582 and 584. Because the GRAS use of a substance is not subject to premarket review and approval by FDA, it is impracticable to list all substances that are used in food on the basis of a conclusion of GRAS status, therefore these lists are not all-inclusive. However, FDA encourages any person who intends to market a food substance on the basis of a conclusion of GRAS status to submit a GRAS notice to FDA.^[3]

AAFCO is an independent organization with voluntary membership of State and Federal regulatory officials in the United States as well as officials from government agencies in other countries, that are responsible for the execution of laws, including regulations, in their jurisdictions pertaining to the production, labeling, distribution, use, or sale of animal food (including ingredients).

Since 1920, AAFCO has maintained the AAFCO OP, which contains, among other things, a comprehensive list of substances added to animal food (commonly referred to as ingredients), many of which include definitions established through the AAFCO ingredient definition request process. Because most States adopt the ingredient definitions listed in the AAFCO OP under their State laws, the AAFCO ingredient definition request process facilitates the marketing of animal food ingredients under those State laws. In 2007, FDA entered into an MOU, 225-07-7001, with AAFCO that outlines how FDA would provide its scientific and technical expertise to AAFCO in reviewing requested ingredient definitions.^[4] This MOU has been renewed and revised several times. The current MOU expires in October 2024, and will not be renewed. See https://www.fda.gov/​animal-veterinary/​animal-food-feeds/​fda-letter-stakeholders-acknowledgment-expiring-fda-aafco-mou.

We are issuing this draft guidance to describe our policy that FDA generally does not intend to initiate enforcement action with respect to the food additive approval requirements of the FD&C Act for the ingredient, or animal food containing the ingredient, that is listed in the Official Common or Usual Names and Definitions of Feed Ingredients section of chapter six of the AAFCO 2024 OP. We have reviewed many of these ingredients through our participation in the AAFCO ingredient definition request process and recommended that the ingredient definitions, including specifications for use, be added to the AAFCO OP. For those ingredients listed in the 2024 AAFCO OP that are not approved food additives or GRAS and that we did not review as part of the AAFCO ingredient definition request process, at this time, we are not aware of any safety concerns that would cause us to request that an ingredient be withdrawn from the AAFCO OP, and many have a long history of use in animal food. We anticipate that our policy generally not to initiate enforcement action regarding the marketing of these ingredients may help minimize disruptions in access to, or shortages of, ingredients that have been commonly used and relied on for years. Additionally, this approach would allow us to focus our resources on reviewing new ingredients before they are marketed and addressing unsafe ingredients in the marketplace. In addition, the draft guidance describes FDA's policy with respect to the use of certain ingredient names listed in chapter six of the AAFCO 2024 OP on animal food labels.

There is a small set of animal food ingredients that FDA has reviewed in accordance with the procedures described in the MOU and has recommended for inclusion in the AAFCO OP, but for which AAFCO has not completed the remainder of their new ingredient definition request process. FDA is considering a similar enforcement policy that may be described in future guidance for these ingredients and we are seeking public comment on ways to make these ingredients and their uses known to the public. See the instructions included in this notice for how to comment.

Elsewhere in this issue of the Federal Register , we are publishing a notice of availability for a draft guidance on our new Animal Food Ingredient Consultation (AFIC) process to help provide an additional way for firms developing animal food ingredients to consult with the Center for Veterinary Medicine following the expiration of the MOU with AAFCO and while FDA evaluates the animal Food Additive Petition and GRAS Notification programs. To inform that evaluation, elsewhere in this issue of the Federal Register , we also are publishing a notice seeking stakeholder input regarding our current animal Food Additive Petition and GRAS Notification review programs for animal food ingredients. We also intend to hold listening sessions and will later provide scheduling information for those listening sessions. While FDA evaluates its current Food Additive Petition and GRAS Notification programs, the AFIC process will provide an additional way for firms to consult with FDA regarding new animal food ingredients and for FDA to review information regarding such ingredients and identify any safety concerns associated with them. The AFIC process also will allow for public awareness of and input on ingredients that FDA is reviewing. See https://www.fda.gov/​animal-veterinary/​animal-food-feeds/​animal-food-ingredient-consultations-afics. Our goal is to support innovation in animal food technologies while always maintaining as our priority the production of safe animal food, which includes safety of food for animals consuming the ingredient and for people who consume edible animal products. We encourage firms to have conversations with us early and often in their ingredient and process development phase.

This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.” 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.

II. Paperwork Reduction Act of 1995

FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

III. Electronic Access

Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/​animal-veterinary/​guidance-regulations/​guidance-industry, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.regulations.gov.

Dated: August 6, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.

Footnotes

1.  See 21 CFR part 570, subpart E.

2.  The Office of the Federal Register has published this document under the category “Proposed Rules” pursuant to 1 CFR 5.9(c). The Office of the Federal Register's categorization is solely for purposes of publication in the Federal Register and does not change the nature of the document and is not intended to affect its validity, content, or intent. See 1 CFR 5.1(c).

3.   https://www.fda.gov/​animal-veterinary/​animal-food-feeds/​generally-recognized-safe-gras-notification-program.

4.   https://www.fda.gov/​about-fda/​domestic-mous/​mou-225-07-7001.