81 FR 42585 - Society of the Plastics Industry, Inc.; Filing of Food Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 126 (June 30, 2016)

Page Range		42585-42587
FR Document		2016-15474

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Keller and Heckman LLP on behalf of the Society of the Plastics Industry, Inc. (Petitioner or SPI), requesting that we amend our food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers because this use has been abandoned.

Federal Register, Volume 81 Issue 126 (Thursday, June 30, 2016)

[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Proposed Rules]
[Pages 42585-42587]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-15474]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. FDA-2016-F-1805]

Society of the Plastics Industry, Inc.; 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 Keller and Heckman LLP on
behalf of the Society of the Plastics Industry, Inc. (Petitioner or
SPI), requesting that we amend our food additive regulations to no
longer provide for the use of potassium perchlorate as an additive in
closure-sealing gaskets for food containers because this use has been
abandoned.

DATES: The food additive petition was filed on May 11, 2016. Submit
either electronic or written comments by August 29, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-F-1805 for ``Filing of Food Additive Petition: Society of the
Plastics Industry, Inc.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions: To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be

[[Page 42586]]

made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, 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: Thomas C. Zebovitz, Center for Food
Safety and Applied Nutrition (HFS-275), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1244.

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 6B4816) submitted on behalf of the
Society of the Plastics Industry, Inc. (Petitioner or SPI) by Keller
and Heckman LLP, 1001 G Street NW., Suite 500 West, Washington, DC
20001. The petition proposes that we 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 because the use has been
intentionally and permanently abandoned.

II. Abandonment

Under section 409(i) of the FD&C Act, we ``shall by regulation
prescribe the procedure by which regulations under the foregoing
provisions of this section may be amended or repealed, and such
procedure shall conform to the procedure provided in this section for
the promulgation of such regulations.'' Our regulations specific to
administrative actions for food additives provide that the
Commissioner, on his own initiative or on the petition of any
interested person, under 21 CFR part 10, may propose the issuance of a
regulation amending or repealing a regulation pertaining to a food
additive or granting or repealing an exception for such additive (21
CFR 171.130(a)). These regulations further provide that any such
petition shall include an assertion of facts, supported by data,
showing that new information exists with respect to the food additive
or that new uses have been developed or old uses abandoned, that new
data are available as to toxicity of the chemical, or that experience
with the existing regulation or exemption may justify its amendment or
repeal. New data must be furnished in the form specified in 21 CFR
171.1 and 171.100 for submitting petitions (21 CFR 171.130(b)). Under
these regulations, a petitioner may propose that we amend a food
additive regulation if the petitioner can demonstrate that there are
``old uses abandoned'' for the relevant food additive. Such abandonment
must be complete for any intended uses in the U.S. market. While
section 409 of the FD&C Act and Sec. 171.130 also provide for amending
or revoking a food additive regulation based on safety, an amendment or
revocation based on abandonment is not based on safety, but is based on
the fact that regulatory authorization is no longer necessary because
the use of the food additive has been abandoned.
Abandonment may be based on the abandonment of certain authorized
food additive uses for a substance (e.g., if a substance is no longer
used in certain product categories), or on the abandonment of all
authorized food additive uses of a substance (e.g., if a substance is
no longer being manufactured). If a petition seeks an amendment to a
food additive regulation based on the abandonment of certain uses of
the food additive, such uses must be adequately defined so that both
the scope of the abandonment and any amendment to the food additive
regulation are clear.
The SPI petition includes the following information to support the
claim that the use of potassium perchlorate as an additive in closure-
sealing gaskets for food containers has been abandoned in the U.S.
market. The petition states that three of the four companies that filed
the food additive petitions that resulted in the listing for potassium
perchlorate in 21 CFR 177.1210 are still operating, and that the fourth
company is no longer in business. The Petitioner polled the three
companies about their use of potassium perchlorate in closure-sealing
gaskets for food containers asking them to verify that they do not: (1)
Currently manufacture potassium perchlorate for use as a component of
closures with sealing gaskets for food containers in the United States;
(2) currently import potassium perchlorate for use as a component of
closures with sealing gaskets for food containers in the United States;
(3) intend to manufacture or import potassium perchlorate for use as a
component of closures with sealing gaskets for food containers in the
United States in the future; or (4) currently maintain any inventory of
potassium perchlorate for sale or distribution into commerce that is
intended to be marketed for use as a component of closures with sealing
gaskets for food containers in the United States. The petition includes
signed letters from the three companies confirming agreement to these
four points.
The petition also includes a signed letter from American Pacific
Corporation, Western Electrochemical Company (AMPAC), which the
Petitioner states is the sole domestic manufacturer of potassium
perchlorate in the United States. The letter states that AMPAC does not
manufacture, import, or maintain any inventory of potassium perchlorate
for sale or distribution into commerce into the food-contact market for
use in closure-sealing gaskets for food containers in the United
States.
The petition also asserts that SPI surveyed the member companies
that make up SPI's Food, Drug, and Cosmetic Packaging Materials
Committee (FDCPMC). According to the petition, no FDCPMC member company
responded that it had any knowledge or reason to believe that potassium
perchlorate was being manufactured, used, distributed, or imported into
the United States for use in the manufacture of closures with sealing
gaskets for food-contact applications. The petition also states that
SPI has been unable to identify any company with records indicating
that potassium perchlorate was actually used as a component of closure-
sealing gaskets for food containers.
A supplement to the petition, dated May 16, 2016, asserts that SPI
contacted all known U.S.-based manufacturers of gaskets for food-
contact applications, which the Petitioner asserts constitute the
substantial majority, if not all of such manufacturers. The supplement
asserts that each company indicated to SPI that it does not continue to
use potassium perchlorate in the manufacture of gaskets for food-
contact materials.
We expressly request comments on the Petitioner's request to amend
21 CFR 177.1210 of the food additive regulations to no longer permit
the use

[[Page 42587]]

of potassium perchlorate in closure-sealing gaskets used for food
containers. As noted, the basis for the proposed amendment is that the
use of potassium perchlorate in closure-sealing gaskets for food
containers has been permanently and completely abandoned. Accordingly,
we request comments that address whether this use of potassium
perchlorate has been completely abandoned, such as information on
whether closure-sealing gaskets containing potassium perchlorate are
currently being introduced or delivered for introduction into the U.S.
market. We are not aware of information that suggests continued use of
potassium perchlorate as a component of closure-sealing gaskets in
contact with food.
We are providing the public with 60 days to submit comments. We
anticipate that some interested persons may wish to provide FDA with
certain information they consider to be trade secret or confidential
commercial information (CCI) that would be exempt under Exemption 4 of
the Freedom of Information Act (5 U.S.C. 552). Interested persons may
claim information that is submitted to FDA as CCI or trade secret by
clearly marking both the document and the specific information as
``confidential.'' Information so marked will not be disclosed except in
accordance with the Freedom of Information Act (5 U.S.C. 552) and our
disclosure regulations (21 CFR part 20). For electronic submissions to
http://www.regulations.gov, indicate in the ``comments'' box of the
appropriate docket that your submission contains confidential
information. Interested persons must also submit a copy of the comment
that does not contain the information claimed as confidential for
inclusion in the public version of the official record. Information not
marked confidential will be included in the public version of the
official record without prior notice.
We are not requesting comments on the safety of the use of
potassium perchlorate in closure-sealing gaskets for food containers
because such information is not relevant to abandonment, which is the
basis of the proposed action. We will not consider any comments
addressing the safety of potassium perchlorate or containing safety
information on this substance in our evaluation of this petition. In
addition to our consideration of this petition, we are considering
information on the safety of potassium perchlorate as an additive in
closure-sealing gaskets for food containers as part of our
consideration of a petition designated for reference as FAP 4B4808 (see
80 FR 13508 (March 16, 2015)). 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: June 24, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2016-15474 Filed 6-29-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Proposed Rules 42587

of potassium perchlorate in closure- for reference as FAP 4B4808 (see 80 FR restricted by statute. Multimedia
sealing gaskets used for food containers. 13508 (March 16, 2015)). We have submissions (audio, video, etc.) must be
As noted, the basis for the proposed determined under 21 CFR 25.32(m) that accompanied by a written comment.
amendment is that the use of potassium this action is of a type that does not The written comment is considered the
perchlorate in closure-sealing gaskets individually or cumulatively have a official comment and should include
for food containers has been significant effect on the human discussion of all points you wish to
permanently and completely environment. Therefore, neither an make. The EPA will generally not
abandoned. Accordingly, we request environmental assessment nor an consider comments or comment
comments that address whether this use environmental impact statement is contents located outside of the primary
of potassium perchlorate has been required. submission (i.e. on the web, cloud, or
completely abandoned, such as Dated: June 24, 2016.
other file sharing system). For
information on whether closure-sealing additional submission methods, please
Dennis M. Keefe,
gaskets containing potassium contact Ms. Adina Wiley, (214) 665–
perchlorate are currently being Director, Office of Food Additive Safety, 2115, wiley.adina@epa.gov. For the full
Center for Food Safety and Applied Nutrition.
introduced or delivered for introduction EPA public comment policy,
[FR Doc. 2016–15474 Filed 6–29–16; 8:45 am] information about CBI or multimedia
into the U.S. market. We are not aware
of information that suggests continued BILLING CODE 4164–01–P submissions, and general guidance on
use of potassium perchlorate as a making effective comments, please visit
component of closure-sealing gaskets in http://www2.epa.gov/dockets/
contact with food. ENVIRONMENTAL PROTECTION commenting-epa-dockets.
We are providing the public with 60 AGENCY Docket: The index to the docket for
days to submit comments. We anticipate this action is available electronically at
that some interested persons may wish 40 CFR Part 52 www.regulations.gov and in hard copy
to provide FDA with certain information [EPA–R06–OAR–2014–0221; FRL–9948–56– at the EPA Region 6, 1445 Ross Avenue,
they consider to be trade secret or Region 6] Suite 700, Dallas, Texas. While all
confidential commercial information documents in the docket are listed in
(CCI) that would be exempt under Approval and Promulgation of the index, some information may be
Exemption 4 of the Freedom of Implementation Plans; Oklahoma; publicly available only at the hard copy
Information Act (5 U.S.C. 552). Revisions to Major New Source Review location (e.g., copyrighted material), and
Interested persons may claim Permitting some may not be publicly available at
information that is submitted to FDA as either location (e.g., CBI).
AGENCY: Environmental Protection
CCI or trade secret by clearly marking FOR FURTHER INFORMATION CONTACT: Ms.
Agency (EPA).
both the document and the specific Adina Wiley, (214) 665–2115,
information as ‘‘confidential.’’ ACTION: Proposed rule.
wiley.adina@epa.gov. To inspect the
Information so marked will not be SUMMARY: The Environmental Protection hard copy materials, please schedule an
disclosed except in accordance with the Agency (EPA) is proposing to approve appointment with Ms. Adina Wiley or
Freedom of Information Act (5 U.S.C. severable portions of revisions to the Mr. Bill Deese at 214–665–7253.
552) and our disclosure regulations (21 Oklahoma New Source Review (NSR) SUPPLEMENTARY INFORMATION:
CFR part 20). For electronic submissions State Implementation Plan (SIP) Throughout this document wherever
to http://www.regulations.gov, indicate submitted by the State of Oklahoma on ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean
in the ‘‘comments’’ box of the June 24, 2010; July 16, 2010; December the EPA.
appropriate docket that your submission 27, 2010; February 6, 2012; and January
contains confidential information. I. Background
18, 2013. These revisions update the
Interested persons must also submit a Prevention of Significant Deterioration A. The CAA and SIPs
copy of the comment that does not (PSD) and Nonattainment NSR (NNSR)
contain the information claimed as The CAA at Section 110(a)(2)(C)
permit programs to be consistent with requires states to develop and submit to
confidential for inclusion in the public
federal permitting requirements and the EPA for approval into the SIP,
version of the official record.
make general updates to the Oklahoma preconstruction review and permitting
Information not marked confidential
SIP to support major NSR permitting. programs applicable to certain new and
will be included in the public version
We are proposing this action under modified stationary sources of air
of the official record without prior
section 110, parts C and D of the Clean pollutants for attainment/unclassifiable
notice.
We are not requesting comments on Air Act (CAA). and nonattainment areas that cover both
the safety of the use of potassium DATES: Written comments must be major and minor new sources and
perchlorate in closure-sealing gaskets received on or before August 1, 2016. modifications, collectively referred to as
for food containers because such ADDRESSES: Submit your comments, the NSR SIP. The CAA NSR SIP
information is not relevant to identified by Docket No. EPA–R06– program is composed of three separate
abandonment, which is the basis of the OAR–2014–0221, at http:// programs: PSD, NNSR, and Minor NSR.
proposed action. We will not consider www.regulations.gov or via email to PSD is established in part C of title I of
any comments addressing the safety of wiley.adina@epa.gov. Follow the online the CAA and applies in areas that are
potassium perchlorate or containing instructions for submitting comments. designated as meeting the National
sradovich on DSK3GDR082PROD with PROPOSALS

safety information on this substance in Once submitted, comments cannot be Ambient Air Quality Standards
our evaluation of this petition. In edited or removed from Regulations.gov. (NAAQS), i.e., ‘‘attainment areas,’’ as
addition to our consideration of this The EPA may publish any comment well as areas designated as
petition, we are considering information received to its public docket. Do not ‘‘unclassifiable’’ because there is
on the safety of potassium perchlorate submit electronically any information insufficient information to determine if
as an additive in closure-sealing gaskets you consider to be Confidential the area meets the NAAQS. The NNSR
for food containers as part of our Business Information (CBI) or other SIP program is established in part D of
consideration of a petition designated information whose disclosure is title I of the CAA and applies in areas

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Document Created: 2018-02-08 07:45:34
Document Modified: 2018-02-08 07:45:34

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notice of petition.
Dates		The food additive petition was filed on May 11, 2016. Submit either electronic or written comments by August 29, 2016.
Contact		Thomas C. Zebovitz, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1244.
FR Citation		81 FR 42585

81 FR 42585 - Society of the Plastics Industry, Inc.; Filing of Food Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 126 (June 30, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration