Indirect Food Additives: Polymers, 20829-20832 [2017-08988]
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Federal Register / Vol. 82, No. 85 / Thursday, May 4, 2017 / Rules and Regulations
at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the
date this document publishes in the
Federal Register, but Web sites are
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1. FDA, interim economic impact analysis for
‘‘Food Labeling; Nutrition Labeling of
Standard Menu Items in Restaurants and
Similar Retail Food Establishments;
Extension of Compliance Date; Request
for Comment,’’ April 2017. Available at:
https://www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/
EconomicAnalyses.
Dated: May 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–09029 Filed 5–1–17; 4:15 pm]
BILLING CODE 4164–01–P
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.
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
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SUMMARY:
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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
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20829
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/201523389.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
§ 177.1210 (21 CFR 177.1210) to no
longer provide for the use of potassium
perchlorate as an additive in closuresealing gaskets for food containers
because the use has been intentionally
and permanently abandoned.
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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 § 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 (§ 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
(§ 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 § 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
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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
§ 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 § 177.1210 do
not use potassium perchlorate for foodcontact 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 § 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
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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
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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
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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
(§ 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
§ 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
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20831
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 § 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
§ 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 § 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 § 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 § 171.1(h), we will
delete from the documents any
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Federal Register / Vol. 82, No. 85 / Thursday, May 4, 2017 / Rules and Regulations
materials that are not available for
public disclosure.
of Food and Drugs, 21 CFR part 177 is
amended as follows:
VI. Analysis of Environmental Impact
PART 177—INDIRECT FOOD
ADDITIVES: POLYMERS
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.
1. The authority citation for part 177
continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348, 379e.
§ 177.1210
[Amended]
2. In § 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]
VII. Paperwork Reduction Act of 1995
BILLING CODE 4164–01–P
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.
DEPARTMENT OF HOMELAND
SECURITY
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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
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Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2017–0002; Internal
Agency Docket No. FEMA–8477]
Suspension of Community Eligibility
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
This rule identifies
communities where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP) that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date. Also, information
identifying the current participation
status of a community can be obtained
from FEMA’s Community Status Book
(CSB). The CSB is available at https://
www.fema.gov/national-floodinsurance-program-community-statusbook.
SUMMARY:
The effective date of each
community’s scheduled suspension is
the third date (‘‘Susp.’’) listed in the
third column of the following tables.
DATES:
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If
you want to determine whether a
particular community was suspended
on the suspension date or for further
information, contact Patricia Suber,
Federal Insurance and Mitigation
Administration, Federal Emergency
Management Agency, 400 C Street SW.,
Washington, DC 20472, (202) 646–4149.
SUPPLEMENTARY INFORMATION: The NFIP
enables property owners to purchase
Federal flood insurance that is not
otherwise generally available from
private insurers. In return, communities
agree to adopt and administer local
floodplain management measures aimed
at protecting lives and new construction
from future flooding. Section 1315 of
the National Flood Insurance Act of
1968, as amended, 42 U.S.C. 4022,
prohibits the sale of NFIP flood
insurance unless an appropriate public
body adopts adequate floodplain
management measures with effective
enforcement measures. The
communities listed in this document no
longer meet that statutory requirement
for compliance with program
regulations, 44 CFR part 59.
Accordingly, the communities will be
suspended on the effective date in the
third column. As of that date, flood
insurance will no longer be available in
the community. We recognize that some
of these communities may adopt and
submit the required documentation of
legally enforceable floodplain
management measures after this rule is
published but prior to the actual
suspension date. These communities
will not be suspended and will continue
to be eligible for the sale of NFIP flood
insurance. A notice withdrawing the
suspension of such communities will be
published in the Federal Register.
In addition, FEMA publishes a Flood
Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard
Areas (SFHAs) in these communities.
The date of the FIRM, if one has been
published, is indicated in the fourth
column of the table. No direct Federal
financial assistance (except assistance
pursuant to the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act not in connection with a
flood) may be provided for construction
or acquisition of buildings in identified
SFHAs for communities not
participating in the NFIP and identified
for more than a year on FEMA’s initial
FIRM for the community as having
flood-prone areas (section 202(a) of the
Flood Disaster Protection Act of 1973,
42 U.S.C. 4106(a), as amended). This
prohibition against certain types of
Federal assistance becomes effective for
the communities listed on the date
FOR FURTHER INFORMATION CONTACT:
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Agencies
[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.
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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.
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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