Proposed Rule2024-17781
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Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Draft Guidance for Industry; Availability
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Published
August 9, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #293 entitled "FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients." This draft guidance, when finalized, will communicate FDA's enforcement policy regarding ingredients listed in chapter six of the 2024 Association of American Feed Control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.
Full Text
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<title>Federal Register, Volume 89 Issue 154 (Friday, August 9, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Draft Guidance for Industry; Availability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announcing the availability of a draft guidance for industry (GFI) #293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 This draft guidance, when finalized, will communicate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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#01626960736d6e7575642f626e6f766078416765602f6969722f666e77"><span class="__cf_email__" data-cfemail="cfaca7aebda3a0bbbbaae1aca0a1b8aeb68fa9abaee1a7a7bce1a8a0b9">[email protected]</span></a>.
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\ <a href="https://www.fda.gov/animal-veterinary/animal-food-feeds/generally-recognized-safe-gras-notification-program">https://www.fda.gov/animal-veterinary/animal-food-feeds/generally-recognized-safe-gras-notification-program</a>.
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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
<a href="https://www.fda.gov/animal-veterinary/animal-food-feeds/fda-letter-stakeholders-acknowledgment-expiring-fda-aafco-mou">https://www.fda.gov/animal-veterinary/animal-food-feeds/fda-letter-stakeholders-acknowledgment-expiring-fda-aafco-mou</a>.
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\4\ <a href="https://www.fda.gov/about-fda/domestic-mous/mou-225-07-7001">https://www.fda.gov/about-fda/domestic-mous/mou-225-07-7001</a>.
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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
<a href="https://www.fda.gov/animal-veterinary/animal-food-feeds/animal-food-ingredient-consultations-afics">https://www.fda.gov/animal-veterinary/animal-food-feeds/animal-food-ingredient-consultations-afics</a>. 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 <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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