Document ID: FDA-2023-F-0147-0001
Agency: fda
Document Type: Proposed Rule
Title: Micro-Tracers, Inc.; Filing of Food Additive Petition
Posted Date: 2023-02-06T05:00Z

[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Proposed Rules]
[Page 7657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02449]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2023-F-0147]

Micro-Tracers, Inc.; Filing of Food Additive Petition

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 petition, submitted by Micro-Tracers, Inc., 
proposing that the food additive regulations be amended to permit the 
use of ethyl cellulose as a matrix scaffolding in tracers for use in 
feeds at no more than 0.09 grams per ton of feed (0.1 ppm).

DATES: The food additive petition was filed on December 12, 2022.

ADDRESSES: For access to the docket to read background documents or 
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.

FOR FURTHER INFORMATION CONTACT: Megan Hall, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-221), 
Rockville, MD 20855, 301-796-3801.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice 
that we have filed a food additive petition (FAP 2316), submitted by 
Micro-Tracers, Inc., 1375 Van Dyke Ave., San Francisco, CA 94124. The 
petition proposes to amend Title 21 of the Code of Federal Regulations 
(CFR) in 21 CFR part 573, Food Additives Permitted in Feed and Drinking 
Water of Animals, to provide for the safe use of ethyl cellulose as a 
matrix scaffolding in tracers for use in feeds at no more than 0.09 
grams per ton of feed (0.1 ppm).
    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: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02449 Filed 2-3-23; 8:45 am]
BILLING CODE 4164-01-P