Document ID: FDA-2016-F-1805-0003
Agency: fda
Document Type: Rule
Title: Indirect Food Additives: Polymers
Posted Date: 2017-05-04T04:00Z

[Federal Register Volume 82, Number 85 (Thursday, May 4, 2017)]
[Rules and Regulations]
[Pages 20829-20832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08988]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

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

Indirect Food Additives: Polymers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
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. This action is in 
response to a petition filed by Keller and Heckman LLP on behalf of the 
Society of the Plastics Industry, Inc.

DATES: This rule is effective May 4, 2017. Submit either electronic or 
written objections and requests for a hearing on the final rule by June 
5, 2017. See the ADDRESSES section, and SUPPLEMENTARY INFORMATION 
section VIII of this document, for further information on the filing of 
objections.

ADDRESSES: You may submit objections and requests for a hearing as 
follows. Please note that late, untimely filed objections will not be 
considered. Electronic objections must be submitted on or before June 
5, 2017. The https://www.regulations.gov electronic filing system will 
accept comments until midnight Eastern Time at the end of June 5, 2017. 
Objections received by mail/hand delivery/courier (for written/paper 
submissions) will be considered timely if they are postmarked or the 
delivery service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your 
objection 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 objection, that information will be 
posted on https://www.regulations.gov.
     If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection 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 objections submitted to the Division of 
Dockets Management, FDA will post your objection, 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 ``Indirect Food Additives: Polymers.'' Received 
objections, those filed in a timely manner (see DATES), will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://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 an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objections 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.'' We 
will review this copy, including the claimed confidential information, 
in our 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 https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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: Vivian Gilliam, Center for Food Safety 
and Applied Nutrition (HFS-275), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740-3835, 240-402-1193.

SUPPLEMENTARY INFORMATION:

I. Background

    In a document published in the Federal Register of June 30, 2016 
(81 FR 42585), we announced that we filed a food additive petition (FAP 
6B4816) submitted on behalf of Society of the Plastics Industry, Inc. 
(SPI) by Keller and Heckman LLP, 1001 G Street NW., Suite 500 West, 
Washington, DC 20001. The petition proposed to amend Sec.  177.1210 (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.

[[Page 20830]]

    In response to food additive petitions filed in 1962, FDA 
authorized the use of 66 substances, including potassium perchlorate, 
for the use in manufacturing closure-sealing gaskets under Sec.  
177.1210 (27 FR 7092, July 26, 1962).

II. Evaluation of Abandonment

    Section 409(i) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 348(i)) states that we shall, by regulation, 
establish the procedure for amending or repealing a food additive 
regulation, and that this procedure shall conform to the procedure 
provided in section 409 of the FD&C Act. Our regulations specific to 
administrative actions for food additives provide that the Commissioner 
of Food and Drugs, on his own initiative or on the petition of any 
interested person, may propose the issuance of a regulation amending or 
repealing a regulation pertaining to a food additive (Sec.  171.130(a) 
(21 CFR 171.130(a))). These regulations further provide that any such 
petition must 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 submitted as a food additive petition must be furnished in the 
form specified in 21 CFR 171.1 and 171.100 for submitting such 
petitions (Sec.  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 and permanent for any 
intended uses in the U.S. market. Although 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 the safety of the food additive. Instead, 
the amendment or revocation is based on the fact that regulatory 
authorization is no longer necessary because the use of the food 
additive has been permanently and completely 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 present petition includes the following information to support 
the claim that the use of potassium perchlorate as a food additive in 
closure-sealing gaskets for food containers has been abandoned in the 
U.S. market: (1) None of the companies that originally petitioned for 
the inclusion of potassium perchlorate in Sec.  177.1210 use potassium 
perchlorate for food-contact applications in the United States; (2) the 
sole domestic manufacturer of potassium perchlorate does not market the 
substance into food contact applications in the United States; (3) the 
major domestic manufacturers of gaskets do not use potassium 
perchlorate in the manufacture of their products; and (4) none of the 
member companies, which include domestic and international companies, 
surveyed by SPI indicated that they had any knowledge or reason to 
believe that potassium perchlorate was being used in closures with 
sealing gaskets for food containers.
    First, the petition provided information to show that the original 
petitioners who filed the food additive petitions that resulted in the 
listing of potassium perchlorate in Sec.  177.1210 do not use potassium 
perchlorate for food-contact applications in the United States. The 
petition stated that three of the original four companies that filed 
the food additive petitions that resulted in the listing for potassium 
perchlorate in Sec.  177.1210 are still operating, and that the 
division of the fourth company that participated in the original 
petition is no longer in business. The petitioner surveyed the 
remaining three companies (or their appropriate successor(s) in 
interest) about their use of potassium perchlorate in closures with 
sealing gaskets for food containers and asked 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 included signed letters from the three 
companies confirming agreement with these four points.
    Second, the petition asserted that American Pacific Corporation, 
Western Electrochemical Company (AMPAC) is the sole known domestic 
manufacturer of potassium perchlorate and provided information to show 
that AMPAC does not market the substance for food contact applications 
in the United States. Specifically, the petition included a signed 
letter from AMPAC stating that it does not manufacture, import, or 
maintain any inventory of potassium perchlorate for sale or 
distribution for use in closures with sealing gaskets for food 
containers in the United States. In addition, AMPAC provided 
supplemental information stating that, to the best of its knowledge, 
AMPAC is the sole domestic manufacturer of potassium perchlorate in the 
United States.
    Third, the petition provided information to show that the major 
domestic manufacturers of gaskets do not use potassium perchlorate in 
the manufacture of their products. The petition stated that SPI 
conducted research to identify all major U.S.-based manufacturers of 
closures with sealing gaskets for food containers. The petition further 
stated that SPI contacted each manufacturer identified by its research, 
and that each company confirmed to SPI that it does not use potassium 
perchlorate in the manufacture of gaskets for food contact materials, 
and that potassium perchlorate may never have been used for this 
purpose. According to the petition, these manufactures believe that 
they represent the substantial majority of gasket production, not only 
domestically, but globally as well.
    Fourth, the petition stated that SPI surveyed the 53 companies in 
its Food, Drug, and Cosmetic Packaging Materials Committee (FDCPMC). 
According to the petition, the FDCPMC companies represent the full 
range of the packing supply chain of plastic food-contact material 
manufacturers and their raw material suppliers, and they include 
international companies with affiliates throughout the world. The 
petition stated that the survey asked the companies to advise whether 
they had any actual knowledge or reason to believe that ``potassium 
perchlorate is being manufactured, used, distributed, or imported into 
the U.S. for use in the manufacture of closures with sealing gaskets 
for food-contact applications.'' No company responded that it had any

[[Page 20831]]

knowledge or reason to believe that potassium perchlorate was being 
used in closures with sealing gaskets for food containers. Moreover, 
the petition stated that, in its effort to gather supporting 
information, the petitioner was unable to identify any company with 
memory of, or records indicating, that potassium perchlorate had ever 
been used commercially as a component of closures with sealing gaskets.

III. Comments on the Filing Notification

    We provided 60 days for comments on the filing notification. We 
received two comments. For ease of reading, we preface each comment 
discussion with a numbered ``Comment,'' and the word ``Response'' 
appears before FDA's response. The number assigned is for 
organizational purposes only and does not signify any individual 
comment's value, importance, or order in which it was received.
    (Comment 1) The comment requested that we not make a final decision 
on the petition until after we make a final decision on the petition 
(FAP 4B4808) submitted in 2014 by Natural Resources Defense Council et 
al. (Docket No. FDA-2015-F-0537), asking us to remove certain 
authorizations, including the use of potassium perchlorate that is the 
subject of this petition. The comment stated that we are statutorily 
required to regulate food additives and prevent the use of those that 
are unsafe and that FDA's failure to make a determination based on 
safety would fall short of FDA's statutory duty. The comment stated 
that if we make a decision on the petition based on abandonment before 
making a decision on FAP 4B4808 based on safety, a company may conclude 
that the use of potassium perchlorate in closures with sealing gaskets 
for food containers is generally recognized as safe (GRAS) without 
notifying us. The comment also stated that making a decision on the 
abandonment petition first encourages industry to only consider whether 
a use of a food additive has been abandoned in order to preempt a 
safety decision.
    (Response) FDA disagrees. We are not required to make a final 
decision on FAP 4B4808 before the current petition. With regard to the 
assertion that FDA is required to make a safety determination, FDA has 
numerous responsibilities related to food additives. Each year, FDA 
receives and responds to hundreds of submissions under the various 
petition and notification programs it administers. Therefore, if the 
use of a food additive is no longer authorized in response to an 
abandonment petition, FDA may determine that it is neither necessary 
nor an efficient use of its limited resources to address safety 
arguments related to an abandoned use.
    With regard to the comment's concern that a manufacturer may 
conclude that the use of potassium perchlorate in closures with sealing 
gaskets for food containers is GRAS without notifying us, we note that, 
for a substance to be GRAS based on scientific procedures, the 
scientific data and information about the use of a substance must be 
generally available and there must be general recognition among 
qualified experts that those data and information establish that the 
substance is safe under the conditions of its intended use (Sec.  
170.30). Prior approval as a food additive does not necessarily mean 
that the use of a substance is GRAS (see 81 FR 54960 at 54976, August 
17, 2016). FDA encourages firms to seek our evaluation of any 
conclusion of GRAS status before they introduce the substance into the 
market. In the event that, after the authorization in Sec.  177.1210 
has been removed based on abandonment, a manufacturer later wishes to 
use potassium perchlorate for this intended use, we would expect the 
manufacturer to seek re-authorization through submission of a food 
contact notification or food additive petition because this intended 
use was previously authorized under section 409 of the FD&C Act.
    With regard to the assertion that an abandonment petition could be 
used by industry to preempt a safety determination by FDA, we have the 
discretion to make a safety determination regardless of whether there 
is an abandonment petition.
    (Comment 2) The comment stated that SPI has not considered overseas 
use and manufacturing of potassium perchlorate in closures with sealing 
gaskets for food containers. The comment indicated that SPI had not 
provided sufficient assurances that the uses of potassium perchlorate 
had been abandoned.
    (Response) FDA disagrees. According to the petition, SPI gathered 
information about the use of potassium perchlorate used in closures 
with sealing gaskets for food containers from its member companies, 
which include international companies with affiliates throughout the 
world, and from major domestic manufacturers of gaskets, and these 
manufacturers believe that they represent the substantial majority of 
gasket production, not only domestically, but globally as well. None of 
the companies surveyed reported that they had any reason to believe 
that potassium perchlorate is used to make closures with sealing 
gaskets for food containers. We note that the comment did not provide 
information to show that this use has not been abandoned.
    In addition, when we publish a notice of filing of a food additive 
petition, we notify the World Trade Organization (WTO) of the FAP 
filing. The WTO provides notice of the potential action (in this case, 
the removal of authorization for potassium perchlorate in Sec.  
177.1210 based upon abandonment) to the WTO contact point for each WTO 
member country. The WTO contact point for each country distributes the 
notices to the relevant regulatory agencies and industry bodies within 
that country. If the proposed action affects a member country's trade 
of affected products, it would provide comment to the WTO notice by 
commenting to the appropriate docket established for the petition. We 
did not receive any comments to the WTO notice on the filing of this 
petition.

IV. Conclusion

    We reviewed the data and information in the petition and other 
available relevant material to determine whether the use of potassium 
perchlorate as an additive in closure-sealing gaskets for food 
containers has been permanently and completely abandoned. Based on the 
available information, we conclude that the use of potassium 
perchlorate has been abandoned for use as an additive in closure-
sealing gaskets for food containers. Therefore, we are amending part 
177 as set forth in this document to no longer provide for the use of 
potassium perchlorate as an additive in closure-sealing gaskets for 
food containers.
    Because the authorization for this intended use has been removed 
from Sec.  177.1210 based on abandonment, we do not anticipate that 
industry will resume this intended use in the future. In the event 
that, after the authorization in Sec.  177.1210 has been removed based 
on abandonment, a manufacturer later wishes to use potassium 
perchlorate for this intended use, we would expect the manufacturer to 
seek re-authorization through submission of a food contact notification 
or food additive petition because this intended use was previously 
authorized under section 409 of the FD&C Act.

V. Public Disclosure

    In accordance with Sec.  171.1(h), the petition and the documents 
that we considered and relied upon in reaching our decision to approve 
the petition will be made available for public disclosure (see FOR 
FURTHER INFORMATION CONTACT). As provided in Sec.  171.1(h), we will 
delete from the documents any

[[Page 20832]]

materials that are not available for public disclosure.

VI. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as 
stated in the Federal Register of June 30, 2016, notice of petition for 
FAP 6B4816. We stated that we had 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,'' such 
that neither an environmental assessment nor an environmental impact 
statement is required. We have not received any new information or 
comments that would affect our previous determination.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VIII. Objections

    If you will be adversely affected by one or more provisions of this 
regulation, you may file with the Division of Dockets Management (see 
ADDRESSES) either electronic or written objections. You must separately 
number each objection, and within each numbered objection you must 
specify with particularity the provision(s) to which you object, and 
the grounds for your objection. Within each numbered objection, you 
must specifically state whether you are requesting a hearing on the 
particular provision that you specify in that numbered objection. If 
you do not request a hearing for any particular objection, you waive 
the right to a hearing on that objection. If you request a hearing, 
your objection must include a detailed description and analysis of the 
specific factual information you intend to present in support of the 
objection in the event that a hearing is held. If you do not include 
such a description and analysis for any particular objection, you waive 
the right to a hearing on the objection.
    Any objections received in response to the regulation 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.

List of Subjects in 21 CFR Part 177

    Food additives, Food packaging.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
177 is amended as follows:

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

0
1. The authority citation for part 177 continues to read as follows:

    Authority: 21 U.S.C. 321, 342, 348, 379e.

Sec.  177.1210  [Amended]

0
2. In Sec.  177.1210, in paragraph (b)(5), in table 1, remove the entry 
for ``Potassium perchlorate.''

    Dated: April 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08988 Filed 5-3-17; 8:45 am]
BILLING CODE 4164-01-P