[Federal Register Volume 89, Number 154 (Friday, August 9, 2024)]
[Notices]
[Pages 65363-65364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17779]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2979]
Pre-Market Animal Food Ingredient Review Programs; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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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.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 9, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
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-2979 for ``Pre-Market Animal Food Ingredient Review
Programs, Request for Comments.'' Received comments, those filed in a
timely manner (see ADDRESSES), 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://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.
[[Page 65364]]
FOR FURTHER INFORMATION CONTACT: Charlotte Conway, Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-6768, [email protected].
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.
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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. 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.
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\2\ https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory.
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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]
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