
[Federal Register Volume 80, Number 50 (Monday, March 16, 2015)]
[Proposed Rules]
[Page 13508]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05938]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. FDA-2015-F-0714]


Natural Resources Defense Council et al.; Filing of Food Additive 
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 we have filed a petition, submitted by the Natural Resources 
Defense Council, the Center for Food Safety, the Breast Cancer Fund, 
the Center for Environmental Health, Clean Water Action, the Center for 
Science in the Public Interest, Children's Environmental Health 
Network, Environmental Working Group, and Improving Kids' Environment, 
proposing that we amend our food additive regulation to no longer 
provide for the use of three specific perfluoroalkyl ethyl containing 
food-contact substances (FCSs) as oil and water repellants for paper 
and paperboard for use in contact with aqueous and fatty foods.

DATES: The food additive petition was filed on January 7, 2015.

FOR FURTHER INFORMATION CONTACT: Paul Honigfort, Center for Food Safety 
and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1206.

SUPPLEMENTARY INFORMATION:

I. Background

    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 we have 
filed a food additive petition (FAP 4B4809), submitted by the Natural 
Resources Defense Council, 1152 15th St. NW., Suite 300, Washington, DC 
20005; the Center for Food Safety, 303 Sacramento St., Second Floor, 
San Francisco, CA 94111; Clean Water Action, 144 Eye St. NW., Suite 
400, Washington, DC 20005; the Center for Science in the Public 
Interest, 1220 L St. NW., Suite 300, Washington, DC 20005; Children's 
Environmental Health Network, 110 Maryland Ave. NE., Suite 402, 
Washington, DC 20002; the Breast Cancer Fund, 1388 Sutter St., Suite 
400, San Francisco, CA 94109-5400; the Center for Environmental Health, 
2201 Broadway, Suite 302, Oakland, CA, 94612; Environmental Working 
Group, 1436 U St. NW., Suite 100, Washington, DC 20009; and Improving 
Kids' Environment, 1915 West 18th St., Indianapolis, IN 46202. The 
petition proposes that we amend Sec.  176.170 (21 CFR 176.170) to no 
longer provide for the use of three perfluoroalkyl ethyl containing 
food-contact substances (FCSs) as oil and water repellants for paper 
and paperboard for use in contact with aqueous and fatty foods. The 
three FCSs which are the subjects of this petition are as follows:
    1. Diethanolamine salts of mono- and bis (1H,1H,2H,2H 
perfluoroalkyl) phosphates where the alkyl group is even-numbered in 
the range C8-C18 and the salts have a fluorine content of 52.4 percent 
to 54.4 percent as determined on a solids basis;
    2. Pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20-
alkyl)thio] derivatives, compounds with diethanolamine (CAS Reg. No. 
71608-61-2); and
    3. Perfluoroalkyl substituted phosphate ester acids, ammonium salts 
formed by the reaction of 2,2-bis[([gamma], [omega]-perfluoro C4-20 
alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and ammonium 
hydroxide.

II. Amendment of Sec.  176.170

    In accordance with procedures specified in Sec.  171.130 (21 CFR 
171.130) for amending or revoking a food additive regulation, the 
petition asks us to amend Sec.  176.170 so that it would no longer 
provide for the use of three perfluoroalkyl ethyl containing FCSs as 
oil and water repellants for paper and paperboard for use in contact 
with aqueous and fatty foods. If we determine that new data are 
available regarding the toxicity of these FCSs that justify amending 
Sec.  176.170 so that it would no longer allow their use, we will 
publish such an amendment of the regulation in the Federal Register, as 
set forth in Sec.  171.130 and Sec.  171.100 (21 CFR 171.100).
    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: March 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05938 Filed 3-13-15; 8:45 am]
BILLING CODE 4164-01-P


