Rules and Regulations. Notice; request for comments

Agency: Food and Drug Administration, HHS
Action: Notice; request for comments
Citation: FR Doc. 2024-17779 · Docket No. FDA-2024-N-2979

Summary

The Food and Drug Administration (FDA, we, or Agency) is soliciting comments from the public regarding the Food Additive Petition and Generally Recognized as Safe (GRAS) Notification programs to determine if changes are needed to promote their efficiency. Specific questions and information requests are included in this notice to help guide input from stakeholders and other members of the public.

Dates

Submit either electronic or written comments on the notice by December 9, 2024.

Supplementary Information

I. Background 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 it 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. 1 See 21 CFR part 570, subpart E. 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. 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. Importantly, these lists are not all-inclusive. FDA's Animal Food GRAS Notification Program allows individuals and firms to voluntarily notify FDA that they have concluded that an animal food substance is GRAS under the conditions of its intended use. FDA evaluates the notifier's supporting data and responds to the notifier with a letter stating whether FDA has questions about the notifier's conclusion. If FDA does not have questions, it issues a “no questions” letter. A “no questions” letter is not a legal determination by FDA that the use of a substance is GRAS. These notices are posted on FDA's website under “Current Animal Food GRAS Notices Inventory,” along with FDA's letter to the notifier regarding its evaluation of the notice. 2 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. 2 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory. The Association of American Feed Control Officials (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 and regulations in their jurisdictions pertaining to the production, labeling, distribution, use, or sale of animal food (including ingredients). FDA is a member of AAFCO and provides scientific and technical expertise to the organization. Since 1920, AAFCO has maintained the AAFCO Official Publication, which contains, among other things, a comprehensive list of animal food ingredients, many of which include definitions established through the AAFCO ingredient definition request process. In 2007, FDA entered into a memorandum of understanding (MOU) with AAFCO that outlines how FDA would provide its scientific and technical expertise to AAFCO in reviewing requested ingredient definitions. This MOU has been renewed and revised several times. The current MOU 225-07-7001 expires on October 1, 2024, and will not be renewed. See https://www.fda.gov/animal-veterinary/animal-food-feeds/fda-letter-stakeholders-acknowledgment-expiring-fda-aafco-mou. Elsewhere in this issue of the Federal Register , we are publishing a notice of availability for a draft guidance for industry #293, “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.” This draft guidance, when finalized, will communicate FDA's current thinking on an enforcement policy regarding certain ingredients listed in chapter six of the 2024 AAFCO OP after the expiration of the Agency's MOU with AAFCO. Elsewhere in this issue of the Federal Register , we also are publishing a notice of availability for a draft guidance on our new Animal Food Ingredient Consultation (AFIC) process to provide an additional way for firms developing animal food ingredients to consult with CVM following the expiration of the MOU with AAFCO while FDA evaluates the Food Additive Petition and GRAS Notification programs to determine if changes are needed to promote their efficiency. II. Questions for Consideration We seek input on the following questions regarding the oversight of animal food ingredients: 1. What do you perceive as barriers and/or benefits to pursuing a Food Additive Petition or GRAS Notification? 2. Are there changes that could make the Food Additive Petition and GRAS Notification programs more feasible, such as regulatory changes, changes to guidance, or changes to FDA policy or processes? 3. Is there information that is currently required to be submitted in a Food Additive Petition or GRAS Notification that you do not think is necessary for evaluating the ingredient? 4. Is there information that is not currently required to be submitted in a Food Additive Petition or GRAS Notification, but should be to better enable FDA's evaluation? 5. What review process for proposed animal food ingredients would best enable FDA to review their safety? 6. If you have submitted a request for an ingredient definition through the AAFCO ingredient definition process, what was your reason for doing so instead of filing a Food Additive Petition or submitting a GRAS Notification with FDA? Dated: August 6, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-17779 Filed 8-8-24; 8:45 am]