Proposed Rule2025-14335
APIX Biosciences US LLC; Filing of Food Additive Petition (Animal Use)
Primary source
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Published
July 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by APIX Biosciences US LLC, proposing that we amend our food additive regulations to provide for the safe use of cholesterol as a source of sterol in food for honeybees at a level between 0.009 and 0.5% by weight of the food.
Full Text
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<title>Federal Register, Volume 90 Issue 143 (Tuesday, July 29, 2025)</title>
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[Federal Register Volume 90, Number 143 (Tuesday, July 29, 2025)]
[Proposed Rules]
[Page 35645]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14335]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2025-F-2423]
APIX Biosciences US LLC; Filing of Food Additive Petition (Animal
Use)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of petition.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a food additive petition, submitted by APIX
Biosciences US LLC, proposing that we amend our food additive
regulations to provide for the safe use of cholesterol as a source of
sterol in food for honeybees at a level between 0.009 and 0.5% by
weight of the food.
DATES: The food additive petition was filed on July 11, 2025.
ADDRESSES: For access to the docket to read background documents or
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.
FOR FURTHER INFORMATION CONTACT: Wasima Wahid, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Place, Rockville,
MD 20855, 240-402-5857, <a href="/cdn-cgi/l/email-protection#f4a395879d9995daa3959c9d90b4929095da9c9c87da939b82"><span class="__cf_email__" data-cfemail="abfccad8c2c6ca85fccac3c2cfebcdcfca85c3c3d885ccc4dd">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that
we have filed a food additive petition (FAP 2322), submitted by APIX
Biosciences US LLC, 2580 NE Rivercrest Rd., Fayetteville, AR 72701. The
petition proposes that we amend our food additive regulations in 21 CFR
part 573--Food Additives Permitted in Feed and Drinking Water of
Animals to provide for the safe use of cholesterol as a source of
sterol in food for honeybees at a level between 0.009 and 0.5% by
weight of the food.
The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(r) because it is of a type that does not
individually or cumulatively have a significant effect on the human
environment. In addition, the petitioner has stated that, to their
knowledge, no extraordinary circumstances exist that may significantly
affect the quality of the human environment. If FDA determines a
categorical exclusion applies, neither an environmental assessment nor
an environmental impact statement is required. If FDA determines a
categorical exclusion does not apply, we will request an environmental
assessment and make it available for public inspection.
Dated: July 25, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14335 Filed 7-28-25; 8:45 am]
BILLING CODE P
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