80_FR_13558 80 FR 13508 - Natural Resources Defense Council et al.; Filing of Food Additive Petition

80 FR 13508 - Natural Resources Defense Council et al.; Filing of Food Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 50 (March 16, 2015)

Page Range13508-13508
FR Document2015-05938

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.

Federal Register, Volume 80 Issue 50 (Monday, March 16, 2015) 
[Federal Register Volume 80, Number 50 (Monday, March 16, 2015)]
[Proposed Rules]
[Page 13508]
From the Federal Register Online  [www.thefederalregister.org]
[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

13508 Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Proposed Rules For the reasons set forth in the paperboard for use in contact with II. Amendment of § 176.170 preamble, 7 CFR part 985 is proposed to aqueous and fatty foods. In accordance with procedures be amended as follows: DATES: The food additive petition was specified in § 171.130 (21 CFR 171.130) filed on January 7, 2015. for amending or revoking a food PART 985—MARKETING ORDER FOR FURTHER INFORMATION CONTACT: Paul additive regulation, the petition asks us REGULATING THE HANDLING OF Honigfort, Center for Food Safety and to amend § 176.170 so that it would no SPEARMINT OIL PRODUCED IN THE Applied Nutrition (HFS–275), Food and longer provide for the use of three FAR WEST Drug Administration, 5100 Paint Branch perfluoroalkyl ethyl containing FCSs as ■ 1. The authority citation for 7 CFR Pkwy., College Park, MD 20740–3835, oil and water repellants for paper and part 985 continues to read as follows: 240–402–1206. paperboard for use in contact with SUPPLEMENTARY INFORMATION: aqueous and fatty foods. If we determine Authority: 7 U.S.C. 601–674. that new data are available regarding the ■ 2. A new § 985.234 is added to read I. Background toxicity of these FCSs that justify as follows: Under section 409(b)(5) of the Federal amending § 176.170 so that it would no Food, Drug, and Cosmetic Act (the longer allow their use, we will publish § 985.234 Salable quantities and allotment FD&C Act) (21 U.S.C. 348(b)(5)), we are such an amendment of the regulation in percentages—2015–2016 marketing year. giving notice that we have filed a food the Federal Register, as set forth in The salable quantity and allotment additive petition (FAP 4B4809), § 171.130 and § 171.100 (21 CFR percentage for each class of spearmint submitted by the Natural Resources 171.100). oil during the marketing year beginning Defense Council, 1152 15th St. NW., We have determined under 21 CFR on June 1, 2015, shall be as follows: Suite 300, Washington, DC 20005; the 25.32(m) that this action is of a type that (a) Class 1 (Scotch) oil—a salable Center for Food Safety, 303 Sacramento does not individually or cumulatively quantity of 1,265,853 pounds and an St., Second Floor, San Francisco, CA have a significant effect on the human allotment percentage of 60 percent. 94111; Clean Water Action, 144 Eye St. environment. Therefore, neither an (b) Class 3 (Native) oil—a salable NW., Suite 400, Washington, DC 20005; environmental assessment nor an quantity of 1,341,269 pounds and an the Center for Science in the Public environmental impact statement is allotment percentage of 56 percent. Interest, 1220 L St. NW., Suite 300, required. Dated: March 9, 2015. Washington, DC 20005; Children’s Dated: March 9, 2015. Rex A. Barnes, Environmental Health Network, 110 Leslie Kux, Associate Administrator, Agricultural Maryland Ave. NE., Suite 402, Associate Commissioner for Policy. Marketing Service. Washington, DC 20002; the Breast [FR Doc. 2015–05938 Filed 3–13–15; 8:45 am] [FR Doc. 2015–05681 Filed 3–13–15; 8:45 am] Cancer Fund, 1388 Sutter St., Suite 400, BILLING CODE 4164–01–P BILLING CODE 3410–02–P San Francisco, CA 94109–5400; the Center for Environmental Health, 2201 Broadway, Suite 302, Oakland, CA, DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND 94612; Environmental Working Group, HUMAN SERVICES HUMAN SERVICES 1436 U St. NW., Suite 100, Washington, DC 20009; and Improving Kids’ Food and Drug Administration Food and Drug Administration Environment, 1915 West 18th St., Indianapolis, IN 46202. The petition 21 CFR Parts 170, 177, and 189 21 CFR Part 176 proposes that we amend § 176.170 (21 CFR 176.170) to no longer provide for [Docket No. FDA–2015–F–0537] [Docket No. FDA–2015–F–0714] the use of three perfluoroalkyl ethyl Natural Resources Defense Council et Natural Resources Defense Council et containing food-contact substances al.; Filing of Food Additive Petition al.; Filing of Food Additive Petition (FCSs) as oil and water repellants for paper and paperboard for use in contact AGENCY: Food and Drug Administration, AGENCY: Food and Drug Administration, with aqueous and fatty foods. The three HHS. HHS. FCSs which are the subjects of this ACTION: Notice of petition. ACTION: Notice of petition. petition are as follows: 1. Diethanolamine salts of mono- and SUMMARY: The Food and Drug SUMMARY: The Food and Drug bis (1H,1H,2H,2H perfluoroalkyl) Administration (FDA or we) is Administration (FDA or we) is phosphates where the alkyl group is announcing that we have filed a announcing that we have filed a even-numbered in the range C8-C18 and petition, submitted by the Natural petition, submitted by the Natural the salts have a fluorine content of 52.4 Resources Defense Council, Center for Resources Defense Council, the Center percent to 54.4 percent as determined Food Safety, Clean Water Action, for Food Safety, the Breast Cancer Fund, on a solids basis; Children’s Environmental Health the Center for Environmental Health, 2. Pentanoic acid, 4,4-bis [(gamma- Network, Center for Science in the Clean Water Action, the Center for omega-perfluoro-C8-20-alkyl)thio] Public Interest, Breast Cancer Fund, Science in the Public Interest, derivatives, compounds with Center for Environmental Health, Children’s Environmental Health diethanolamine (CAS Reg. No. 71608– Environmental Working Group, and Rmajette on DSK2VPTVN1PROD with PROPOSALS Network, Environmental Working 61–2); and Improving Kids’ Environment, Group, and Improving Kids’ 3. Perfluoroalkyl substituted proposing that we amend our regulation Environment, proposing that we amend phosphate ester acids, ammonium salts to no longer provide for the use of our food additive regulation to no longer formed by the reaction of 2,2- potassium perchlorate as an additive in provide for the use of three specific bis[([gamma], [omega]-perfluoro C4-20 closure-sealing gaskets for food perfluoroalkyl ethyl containing food- alkylthio) methyl]-1,3-propanediol, containers, revoke the Threshold of contact substances (FCSs) as oil and polyphosphoric acid and ammonium Regulation exemption No. 2005–006 to water repellants for paper and hydroxide. no longer exempt the use of sodium VerDate Sep<11>2014 14:07 Mar 13, 2015 Jkt 235001 PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 E:\FR\FM\16MRP1.SGM 16MRP1


Document Created: 2018-02-21 09:37:38
Document Modified: 2018-02-21 09:37:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of petition.
DatesThe food additive petition was filed on January 7, 2015.
ContactPaul 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.
FR Citation80 FR 13508 
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