Natural Resources Defense Council et al.; Filing of Food Additive Petition, 13508-13510 [2015-05937]

Download as PDF 13508 Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Proposed Rules For the reasons set forth in the preamble, 7 CFR part 985 is proposed to be amended as follows: PART 985—MARKETING ORDER REGULATING THE HANDLING OF SPEARMINT OIL PRODUCED IN THE FAR WEST 1. The authority citation for 7 CFR part 985 continues to read as follows: ■ Authority: 7 U.S.C. 601–674. I. Background 2. A new § 985.234 is added to read as follows: ■ § 985.234 Salable quantities and allotment percentages—2015–2016 marketing year. The salable quantity and allotment percentage for each class of spearmint oil during the marketing year beginning on June 1, 2015, shall be as follows: (a) Class 1 (Scotch) oil—a salable quantity of 1,265,853 pounds and an allotment percentage of 60 percent. (b) Class 3 (Native) oil—a salable quantity of 1,341,269 pounds and an allotment percentage of 56 percent. Dated: March 9, 2015. Rex A. Barnes, Associate Administrator, Agricultural Marketing Service. [FR Doc. 2015–05681 Filed 3–13–15; 8:45 am] BILLING CODE 3410–02–P 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. 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 foodcontact substances (FCSs) as oil and water repellants for paper and Rmajette on DSK2VPTVN1PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 14:07 Mar 13, 2015 Jkt 235001 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: 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 § 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 [(gammaomega-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 2,2bis[([gamma], [omega]-perfluoro C4-20 alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and ammonium hydroxide. PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 II. Amendment of § 176.170 In accordance with procedures specified in § 171.130 (21 CFR 171.130) for amending or revoking a food additive regulation, the petition asks us to amend § 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 § 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 § 171.130 and § 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 170, 177, and 189 [Docket No. FDA–2015–F–0537] Natural Resources Defense Council et al.; Filing of Food Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Children’s Environmental Health Network, Center for Science in the Public Interest, Breast Cancer Fund, Center for Environmental Health, Environmental Working Group, and Improving Kids’ Environment, proposing that we amend our regulation to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers, revoke the Threshold of Regulation exemption No. 2005–006 to no longer exempt the use of sodium SUMMARY: E:\FR\FM\16MRP1.SGM 16MRP1 Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Proposed Rules perchlorate monohydrate as a conductivity enhancer in antistatic agents for use in finished articles in contact with dry foods, and issue a new regulation to prohibit the use of perchlorate in antistatic agents for use in food-contact articles. We are requesting comments on the petition and establishing a comment period of 60 days from the date of publication of this notice. DATES: The food additive petition was filed on December 31, 2014. Submit either electronic or written comments by May 15, 2015. ADDRESSES: You may submit comments by any of the following methods: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Rmajette on DSK2VPTVN1PROD with PROPOSALS Written Submissions Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Docket No. FDA– 2015–F–0537 for this rulemaking. All comments received may be posted without change to https:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov and insert the docket number(s), found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 4B4808), VerDate Sep<11>2014 14:07 Mar 13, 2015 Jkt 235001 submitted by the Natural Resources Defense Council, 1152 15th St. NW., Suite 300, Washington, DC 20005; Center for Food Safety, 303 Sacramento St., Second Floor, San Francisco, CA, 94111; Clean Water Action, 1444 I St. NW., Suite 4000, Washington, DC 20005–6538; Children’s Environmental Health Network, 110 Maryland Ave. NE., Suite 402, Washington, DC 20002; Center for Science in the Public Interest, 1220 L St. NW., Suite 300, Washington, DC 20005; Breast Cancer Fund, 1388 Sutter St., Suite 400, San Francisco, CA 94109–5400; 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: (1) Amend 21 CFR 177.1210 to no longer provide for the use of potassium perchlorate as an additive in closuresealing gaskets for food containers; (2) revoke the Threshold of Regulation (TOR) exemption No. 2005–006 to no longer exempt from regulation under the food additive provisions of the FD&C Act the use of sodium perchlorate monohydrate as a conductivity enhancer in antistatic agents for use in finished articles in contact with dry foods; and (3) issue a new regulation in 21 CFR part 189, subpart D (Substances Prohibited from Indirect Addition to Human Food Through Food-Contact Surfaces) to prohibit the use of perchlorate in antistatic agents for use in food-contact articles. Pursuant to § 189.1(c), we are requesting comments on the petition and establishing a comment period of 60 days from the date of publication of this notice. II. Amendment of 21 CFR 177.1210 The petition asks us to amend § 177.1210 so that it would no longer provide for the use of potassium perchlorate as an additive in closuresealing gaskets for food containers in accordance with procedures specified in 21 CFR 171.130 for amending or revoking a food additive regulation. Specifically, the petition notes that new perchlorate toxicity data are now available which support the requested amendment of § 177.1210. If we determine that new data are available regarding the toxicity of potassium perchlorate that justify amending § 177.1210 so that it would no longer allow the use of potassium perchlorate, we will publish such an amendment of the regulation in the Federal Register, as set forth in § 171.130 and § 171.100. PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 13509 III. Revocation of TOR Exemption No. 2005–006 The petition asks us to revoke TOR exemption No. 2005–006 to no longer exempt from regulation under the food additive provisions of the FD&C Act the use of sodium perchlorate monohydrate as a conductivity enhancer in antistatic agents for use in finished articles in contact with dry foods. Specifically, the petition notes that new toxicity and exposure data on perchlorates are now available which support the requested revocation of TOR exemption No. 2005– 006. The procedures for revoking a TOR exemption are specified in § 170.39(g), which states that if we tentatively conclude that available information on the dietary concentration or safety of sodium perchlorate monohydrate no longer supports a TOR exemption from the food additive regulations, we will notify the persons who requested the exemption of our decision and will provide them with an opportunity to show why the exemption should not be revoked. If after following all of the other procedures required by § 170.39(g) we decide to revoke TOR exemption No. 2005–006, we will publish a notice to that effect in the Federal Register. IV. Issue of a New Regulation in 21 CFR 189 Subpart D The petition asks us to issue a new regulation in part 189, subpart D to prohibit the use of perchlorate in antistatic agents for use in food-contact articles. Specifically, the petition notes that new toxicity and exposure data on perchlorates are now available which support the issue of such a regulation. The procedures for issuing a new regulation in part 189 are set forth in § 189.1. Section 189.1(a) states that ‘‘food ingredients’’ may be prohibited from uses in human food based on ‘‘a determination that [the food ingredients] present a potential risk to the public health or have not been shown by adequate scientific data to be safe for use in human food.’’ Section 189.1(c) requires FDA to publish the petition for comment if the petition contains reasonable grounds to that effect. Accordingly, we request comments on the petition with respect to the petitioners’ request for the issuance of a new regulation in part 189, subpart D to prohibit the use of perchlorate in antistatic agents for use in food-contact articles. 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 E:\FR\FM\16MRP1.SGM 16MRP1 13510 Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Proposed Rules environmental assessment nor an environmental impact statement is required. V. Comments Interested persons may submit either electronic comments to https:// www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: March 9, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–05937 Filed 3–13–15; 8:45 am] BILLING CODE 4164–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R03–OAR–2014–0816; FRL–9924–37– Region 3] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Consumer and Commercial Products, and Mobile Equipment Repair and Refinishing Operations Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the Commonwealth of Virginia. This revision consists of amendments to Virginia’s regulation for consumer and commercial products in order to apply provisions pertaining to portable fuel containers, consumer and commercial products, architectural and industrial maintenance coatings, adhesives, adhesive primers, sealants, and sealant primers to the Richmond volatile organic compound (VOC) Emissions Control Area. The revision also consists of amendments to Virginia’s regulation for existing stationary sources to apply provisions pertaining to mobile equipment repair and refinishing operations in the Richmond VOC Emissions Control Area. This action is being taken under the Clean Air Act (CAA). Rmajette on DSK2VPTVN1PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 14:07 Mar 13, 2015 Jkt 235001 Written comments must be received on or before April 15, 2015. ADDRESSES: Submit your comments, identified by Docket ID Number EPA– R03–OAR–2014–0816 by one of the following methods: A. www.regulations.gov. Follow the on-line instructions for submitting comments. B. Email: powers.marilyn@epa.gov C. Mail: EPA–R03–OAR–2014–0816, Marilyn Powers, Acting Associate Director, Office of Air Program Planning, Mailcode 3AP30, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania. D. Hand Delivery: At the previouslylisted EPA Region III address. Such deliveries are only accepted during the Docket’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to Docket ID No. EPA–R03–OAR–2014– 0816. EPA’s policy is that all comments received will be included in the public docket without change, and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through www.regulations.gov or email. The www.regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the electronic docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, i.e., CBI or other DATES: PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal are available at the Virginia Department of Environmental Quality, 629 East Main Street, Richmond, Virginia 23219. FOR FURTHER INFORMATION CONTACT: Leslie Jones Doherty, (215) 814–3409 or by email at jones.leslie@epa.gov. SUPPLEMENTARY INFORMATION: I. Background On January 26, 2012 (77 FR 3928), EPA issued a final rulemaking notice (FRN) approving a new chapter, 9VAC5 Chapter 45—Consumer and Commercial Products, for inclusion in the Virginia SIP in order to control VOC emissions from various consumer and commercial products within the Northern Virginia and Fredericksburg VOC Emissions Control Areas.1 On April 10, 2014, the Virginia Department of Environmental Quality (VADEQ) submitted a revision to the Virginia SIP. The SIP revision consists of amendments to 9VAC5 Chapter 45 in order to apply provisions pertaining to certain types of consumer and commercial products to the Richmond VOC Emissions Control Area. On June 22, 2004 (69 FR 35253), EPA issued a direct final rulemaking approving a new article, Article 48 of 9VAC5 Chapter 40—Existing Stationary Sources, for inclusion in the Virginia SIP which established emissions standards for mobile equipment repair and refinishing operations in the Northern Virginia VOC Emissions Control Area. This SIP revision consists of amendments to Article 48 of 9VAC5 Chapter 40—Existing Stationary Sources to apply provisions pertaining to mobile equipment repair and refinishing operations in the Richmond VOC Emissions Control Area. II. Summary of SIP Revision The SIP revision consists of amendments to 9VAC5 Chapter 45— Consumer and Commercial Products in order to apply provisions pertaining to portable fuel containers, consumer and commercial products, architectural and 1 ‘‘VOC Emissions Control Area’’ in Virginia is defined by 9VAC5–20–206 as certain control areas by geographic location. E:\FR\FM\16MRP1.SGM 16MRP1

Agencies

[Federal Register Volume 80, Number 50 (Monday, March 16, 2015)]
[Proposed Rules]
[Pages 13508-13510]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05937]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 170, 177, and 189

[Docket No. FDA-2015-F-0537]


Natural Resources Defense Council et al.; Filing of Food Additive 
Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by the Natural Resources 
Defense Council, Center for Food Safety, Clean Water Action, Children's 
Environmental Health Network, Center for Science in the Public 
Interest, Breast Cancer Fund, Center for Environmental Health, 
Environmental Working Group, and Improving Kids' Environment, proposing 
that we amend our regulation to no longer provide for the use of 
potassium perchlorate as an additive in closure-sealing gaskets for 
food containers, revoke the Threshold of Regulation exemption No. 2005-
006 to no longer exempt the use of sodium

[[Page 13509]]

perchlorate monohydrate as a conductivity enhancer in antistatic agents 
for use in finished articles in contact with dry foods, and issue a new 
regulation to prohibit the use of perchlorate in antistatic agents for 
use in food-contact articles. We are requesting comments on the 
petition and establishing a comment period of 60 days from the date of 
publication of this notice.

DATES: The food additive petition was filed on December 31, 2014. 
Submit either electronic or written comments by May 15, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2015-F-0537 for this rulemaking. All comments received may be 
posted without change to https://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

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 4B4808), submitted by the Natural 
Resources Defense Council, 1152 15th St. NW., Suite 300, Washington, DC 
20005; Center for Food Safety, 303 Sacramento St., Second Floor, San 
Francisco, CA, 94111; Clean Water Action, 1444 I St. NW., Suite 4000, 
Washington, DC 20005-6538; Children's Environmental Health Network, 110 
Maryland Ave. NE., Suite 402, Washington, DC 20002; Center for Science 
in the Public Interest, 1220 L St. NW., Suite 300, Washington, DC 
20005; Breast Cancer Fund, 1388 Sutter St., Suite 400, San Francisco, 
CA 94109-5400; 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: 
(1) Amend 21 CFR 177.1210 to no longer provide for the use of potassium 
perchlorate as an additive in closure-sealing gaskets for food 
containers; (2) revoke the Threshold of Regulation (TOR) exemption No. 
2005-006 to no longer exempt from regulation under the food additive 
provisions of the FD&C Act the use of sodium perchlorate monohydrate as 
a conductivity enhancer in antistatic agents for use in finished 
articles in contact with dry foods; and (3) issue a new regulation in 
21 CFR part 189, subpart D (Substances Prohibited from Indirect 
Addition to Human Food Through Food-Contact Surfaces) to prohibit the 
use of perchlorate in antistatic agents for use in food-contact 
articles.
    Pursuant to Sec.  189.1(c), we are requesting comments on the 
petition and establishing a comment period of 60 days from the date of 
publication of this notice.

II. Amendment of 21 CFR 177.1210

    The petition asks us to amend Sec.  177.1210 so that it would no 
longer provide for the use of potassium perchlorate as an additive in 
closure-sealing gaskets for food containers in accordance with 
procedures specified in 21 CFR 171.130 for amending or revoking a food 
additive regulation. Specifically, the petition notes that new 
perchlorate toxicity data are now available which support the requested 
amendment of Sec.  177.1210. If we determine that new data are 
available regarding the toxicity of potassium perchlorate that justify 
amending Sec.  177.1210 so that it would no longer allow the use of 
potassium perchlorate, we will publish such an amendment of the 
regulation in the Federal Register, as set forth in Sec.  171.130 and 
Sec.  171.100.

III. Revocation of TOR Exemption No. 2005-006

    The petition asks us to revoke TOR exemption No. 2005-006 to no 
longer exempt from regulation under the food additive provisions of the 
FD&C Act the use of sodium perchlorate monohydrate as a conductivity 
enhancer in antistatic agents for use in finished articles in contact 
with dry foods. Specifically, the petition notes that new toxicity and 
exposure data on perchlorates are now available which support the 
requested revocation of TOR exemption No. 2005-006.
    The procedures for revoking a TOR exemption are specified in Sec.  
170.39(g), which states that if we tentatively conclude that available 
information on the dietary concentration or safety of sodium 
perchlorate monohydrate no longer supports a TOR exemption from the 
food additive regulations, we will notify the persons who requested the 
exemption of our decision and will provide them with an opportunity to 
show why the exemption should not be revoked. If after following all of 
the other procedures required by Sec.  170.39(g) we decide to revoke 
TOR exemption No. 2005-006, we will publish a notice to that effect in 
the Federal Register.

IV. Issue of a New Regulation in 21 CFR 189 Subpart D

    The petition asks us to issue a new regulation in part 189, subpart 
D to prohibit the use of perchlorate in antistatic agents for use in 
food-contact articles. Specifically, the petition notes that new 
toxicity and exposure data on perchlorates are now available which 
support the issue of such a regulation.
    The procedures for issuing a new regulation in part 189 are set 
forth in Sec.  189.1. Section 189.1(a) states that ``food ingredients'' 
may be prohibited from uses in human food based on ``a determination 
that [the food ingredients] present a potential risk to the public 
health or have not been shown by adequate scientific data to be safe 
for use in human food.'' Section 189.1(c) requires FDA to publish the 
petition for comment if the petition contains reasonable grounds to 
that effect. Accordingly, we request comments on the petition with 
respect to the petitioners' request for the issuance of a new 
regulation in part 189, subpart D to prohibit the use of perchlorate in 
antistatic agents for use in food-contact articles.
    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

[[Page 13510]]

environmental assessment nor an environmental impact statement is 
required.

V. Comments

    Interested persons may submit either electronic comments to https://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at https://www.regulations.gov.

    Dated: March 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05937 Filed 3-13-15; 8:45 am]
BILLING CODE 4164-01-P
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