
[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Proposed Rules]
[Pages 64045-64046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26949]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2018-C-4464]


Impossible Foods, Inc.; Filing of Color 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 Impossible Foods, Inc., 
proposing that the color additive regulations be amended to provide for 
the safe use of soy leghemoglobin as a color additive in plant-based, 
non-animal derived ground beef analogue products.

DATES: The color additive petition was filed on November 5, 2018.

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: Ellen Anderson, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1309.

SUPPLEMENTARY INFORMATION: Under section 721(d)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice 
that we have filed a color additive petition (CAP

[[Page 64046]]

9C0314), submitted by Impossible Foods, Inc., c/o Exponent, Inc., 1150 
Connecticut Avenue NW, Suite 1100, Washington, DC 20036. The petition 
proposes to amend the color additive regulations in part 73 (21 CFR 
part 73), ``Listing of Color Additives Exempt From Certification,'' to 
provide for the safe use of soy leghemoglobin as a color additive in 
plant-based, non-animal derived ground beef analogue products.
    The petitioner has claimed that this action is categorically 
excluded under 21 CFR 25.32(k) because soy leghemoglobin would be added 
directly to food and is intended to remain in food through ingestion by 
consumers and is not intended to replace macronutrients in food. 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: December 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26949 Filed 12-12-18; 8:45 am]
 BILLING CODE 4164-01-P


