
[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Proposed Rules]
[Pages 43093-43094]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17330]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 172 and 182

[Docket Nos. FDA-2013-F-0700 and FDA-2013-P-0472]


Richard C. Theuer; Filing of Food Additive Petition and Citizen 
Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that Richard C. Theuer, Ph.D., has filed a petition proposing that the 
food additive regulations be amended to prohibit the use of carrageenan 
and salts of carrageenan in infant formula. In addition, the petitioner 
has submitted a citizen petition, under FDA regulations, requesting 
that we amend the generally recognized as safe (GRAS) regulations to 
prohibit the use of Chondrus extract (carrageenin) in infant formula.

FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1075.

SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(b)(5)), we are 
giving notice that Richard C. Theuer, Ph.D., 7904 Sutterton Ct., 
Raleigh, NC 27615, has filed a food additive petition (FAP 3A4798; 
Docket No. FDA-2013-F-0700). The petition proposes to amend the food 
additive regulations in 21 CFR 172.620 and 172.626 to prohibit the use 
of carrageenan and salts of carrageenan in infant formula. In addition, 
Dr. Theuer has submitted a citizen petition, under 21 CFR 10.30, 
requesting that 21

[[Page 43094]]

CFR 182.7255 of the GRAS regulations be amended to prohibit the use of 
Chondrus extract (carrageenin) in infant formula (Docket No. FDA-2013-
P-0472). (Carrageenin is an alternate name for carrageenan.)
    Although the petitioner has submitted both a food additive petition 
and a citizen petition, for reasons of administrative efficiency, we 
may address all aspects of the petitions under the procedures 
established in section 409 of the FD&C Act and regulations issued under 
that section.
    We have determined under 21 CFR 25.32(m) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: July 16, 2013.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2013-17330 Filed 7-18-13; 8:45 am]
BILLING CODE 4160-01-P


