Document ID: FDA-2015-F-0537-0001
Agency: fda
Document Type: Proposed Rule
Title: Natural Resources Defense Council et al.; Filing of Food Additive Petition
Posted Date: 2015-03-16T04:00Z

[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]

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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.

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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, 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: http://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 http://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 http://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 http://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 http://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