Arcadia Biosciences, Inc.; Filing of Food Additive Petition (Animal Use)

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Petition for rulemaking.

SUMMARY:

The Food and Drug Administration (FDA or we) is announcing that Arcadia Biosciences, Inc. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of gamma-linolenic acid (GLA) safflower oil as a source of omega-6 fatty acids in dry food for adult cats in the maintenance life stage.

DATES:

The food additive petition was filed on May 1, 2017.

ADDRESSES:

For access to the docket, 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:

Carissa Doody, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6283, carissa.doody@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a food additive petition (FAP 2302) has been filed by Arcadia Biosciences Inc., 202 Cousteau Pl., Suite 200, Davis, CA 95618. The petition proposes to amend Title 21 of the Code of Federal Regulations (CFR) in part 573 (21 CFR part 573) Food Additives Permitted in Feed and Drinking Water of Animals to provide for the safe use of GLA safflower oil as a source of omega-6 fatty acids in dry food for adult cats in the maintenance life stage.

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.