[Federal Register Volume 80, Number 50 (Monday, March 16, 2015)]
[Proposed Rules]
[Pages 13508-13510]
From the Federal Register Online via the Government Publishing 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
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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]
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