[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Proposed Rules]
[Pages 42585-42587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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