Document ID: FDA-2016-F-0784-0001
Agency: fda
Document Type: Proposed Rule
Title: Global Nutrition International; Filing of Food Additive Petition (Animal Use)
Posted Date: 2016-03-21T04:00Z

[Federal Register Volume 81, Number 54 (Monday, March 21, 2016)]
[Proposed Rules]
[Page 14995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06199]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2016-F-0784]

Global Nutrition International; Filing of Food Additive Petition 
(Animal Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA) is announcing we have 
filed a petition, submitted by Global Nutrition International, 
proposing that the food additive regulations be amended to provide for 
the safe use of calcium butyrate as a source of energy in dairy cattle 
feed.

DATES: The food additive petition was filed on February 12, 2016.

FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855, 240-402-6729, chelsea.trull@fda.hhs.gov.

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 2294), submitted by 
Global Nutrition International, Zac de Paron, 5 Rue des Compagnons 
d'Emma[uuml]s, BP 70166, 35301 Foug[egrave]res Cedex, France. The 
petition proposes to amend the 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 calcium butyrate as a source of energy in 
dairy cattle feed.
    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. 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: March 15, 2016.
Tracey H. Forfa,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-06199 Filed 3-18-16; 8:45 am]
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