[Federal Register Volume 89, Number 154 (Friday, August 9, 2024)]
[Proposed Rules]
[Pages 65294-65296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17781]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2024-D-2977]


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Draft Guidance for Industry; Availability

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

ACTION: Notification of availability.

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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announcing the availability of a draft guidance for industry (GFI) #293 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 This draft guidance, when finalized, will communicate 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DATES: Submit either electronic or written comments on the draft 
guidance by September 9, 2024, to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 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://

[[Page 65295]]

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, [email protected].

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.
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    \1\ See 21 CFR part 570, subpart E.
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    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.
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    \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).
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    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\
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    \3\ https://www.fda.gov/animal-veterinary/animal-food-feeds/generally-recognized-safe-gras-notification-program.
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    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.
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    \4\ https://www.fda.gov/about-fda/domestic-mous/mou-225-07-7001.
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    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

[[Page 65296]]

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.
[FR Doc. 2024-17781 Filed 8-8-24; 8:45 am]
BILLING CODE 4164-01-P