Indirect Food Additives: Paper and Paperboard Components, 5-8 [2015-33026]
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[FR Doc. 2015–32985 Filed 12–31–15; 8:45 am]
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[Docket No. FDA–2015–F–0714]
Indirect Food Additives: Paper and
Paperboard Components
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 three
specific perfluoroalkyl ethyl containing
food-contact substances (FCSs) as oil
and water repellants for paper and
paperboard for use in contact with
aqueous and fatty foods because new
data are available as to the toxicity of
substances structurally similar to these
compounds that demonstrate there is no
longer a reasonable certainty of no harm
from the food-contact use of these FCSs.
This action is in response to a petition
SUMMARY:
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filed by the Natural Resources Defense
Council, the Center for Food Safety, the
Breast Cancer Fund, the Center for
Environmental Health, Clean Water
Action, the Center for Science in the
Public Interest, Children’s
Environmental Health Network,
Environmental Working Group, and
Improving Kids’ Environment.
DATES: This rule is effective January 4,
2016. Submit either electronic or
written objections and requests for a
hearing by February 3, 2016. See section
VIII for further information on the filing
of objections.
ADDRESSES: You may submit objections
and requests for a hearing as follows:
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 in
the following way:
• 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–
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Federal Register / Vol. 81, No. 1 / Monday, January 4, 2016 / Rules and Regulations
2015–F–0714 for ‘‘Indirect Food
Additives: Paper and Paperboard
Components.’’ Received objections 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.’’ 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
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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
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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.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 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.
Paul
Honigfort, Center for Food Safety and
Applied Nutrition (HFS–275), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835,
240–402–1206.
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FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
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I. Background
In a notice published in the Federal
Register on March 16, 2015 (80 FR
13508), we announced that we filed a
food additive petition (FAP 4B4809)
submitted by the Natural Resources
Defense Council, 1152 15th St. NW.,
Suite 300, Washington, DC 20005; the
Center for Food Safety, 303 Sacramento
St., Second Floor, San Francisco, CA
94111; Clean Water Action, 1444 Eye St.
NW., Suite 400, Washington, DC 20005;
the Center for Science in the Public
Interest, 1220 L St. NW., Suite 300,
Washington, DC 20005; Children’s
Environmental Health Network, 110
Maryland Ave. NE., Suite 404,
Washington, DC 20002; the Breast
Cancer Fund, 1388 Sutter St., Suite 400,
San Francisco, CA 94109–5400; the
Center for Environmental Health, 2201
Broadway, Suite 302, Oakland, CA
94612; Environmental Working Group,
1436 U St. NW., Suite 100, Washington,
DC 20009; and Improving Kids’
Environment, 1915 West 18th St.,
Indianapolis, IN 46202.
The petition proposed to amend
§ 176.170 (21 CFR 176.170) to no longer
provide for the use of three
perfluoroalkyl ethyl containing FCSs as
oil and water repellants for paper and
paperboard for use in contact with
aqueous and fatty foods. The three FCSs
which are the subjects of this petition
are as follows:
1. Diethanolamine salts of mono- and bis
(1H,1H,2H,2H perfluoroalkyl) phosphates
where the alkyl group is even-numbered in
the range C8–C18 and the salts have a
fluorine content of 52.4 percent to 54.4
percent as determined on a solids basis;
2. Pentanoic acid, 4,4-bis [(gamma-omegaperfluoro-C8-20-alkyl)thio] derivatives,
compounds with diethanolamine (CAS Reg.
No. 71608–61–2); and
3. Perfluoroalkyl substituted phosphate
ester acids, ammonium salts formed by the
reaction of 2,2-bis[([gamma], [omega]perfluoro C4-20 alkylthio) methyl]-1,3propanediol, polyphosphoric acid and
ammonium hydroxide.
II. Evaluation of Safety
The three subject FCSs are regulated
as food additives under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act). Section 409 of the FD&C Act
(21 U.S.C. 348) sets forth the statutory
requirements for food additives. Section
201(s) of the FD&C Act (21 U.S.C.
321(s)) includes substances intended for
use in producing, manufacturing,
packing, processing, preparing, treating,
packaging, transporting, or holding food
among the substances defined as food
additives, provided the intended use
results or may reasonably be expected to
result in it becoming a component of
food and those uses were not sanctioned
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prior to 1958 or are not generally
recognized as safe among experts
qualified by scientific training and
experience to evaluate its safety.
Under section 402(a)(2)(c)(1) of the
FD&C Act (21 U.S.C. 342(a)(2)(c)(1)),
food shall be deemed to be adulterated
if it is or if it bears or contains any food
additive that is unsafe within the
meaning of section 409 of the FD&C Act.
A food additive shall be deemed to be
unsafe under section 409 of the FD&C
Act, in relevant part, unless its use
conforms to a food additive regulation
or an effective food contact notification.
Section 409(i) of the FD&C Act states
that the procedure for amending or
repealing a regulation shall conform to
the procedure for the promulgation of
such regulations. FDA’s regulations
specific to the administrative actions for
food additives provide that the
Commissioner, either 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 appeal. New
data must be furnished in the form
specified in § 171.1 (21 CFR 171.1) and
21 CFR 171.100 for submitting petitions
(see § 171.130(b)). Under these
regulations, a petitioner may propose
that we amend a food additive
regulation if the petitioner can
demonstrate that new data are available
as to the toxicity of the food additive
that may justify amendment of the food
additive regulation.
Under section 409(c)(3) of the FD&C
Act we will not establish a regulation
for the use of a food additive if a fair
evaluation of the data fails to establish
that the proposed use of the food
additive, under the conditions of use to
be specified in the regulation, will be
safe. Our regulations, at 21 CFR
170.3(h)(i), define safety as ‘‘a
reasonable certainty in the minds of
competent scientists that the substance
is not harmful under the intended
conditions of use.’’ In order for FDA to
grant a petition that seeks an
amendment to a food additive
regulation based upon new data
concerning the toxicity of the food
additive, such data must be adequate for
FDA to conclude that there is no longer
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a reasonable certainty of no harm for the
intended use of the substance.
The petition asserts that publically
available information on long-chain
perfluorinated compounds as a
chemical class, which has become
available after the food contact use of
the three FCSs was approved,
demonstrates that there is no longer a
reasonable certainty of no harm from the
food contact use of the three FCSs as
listed in § 176.170.
All three of the FCSs subject to the
petition contain extended alkyl chains
where all of the hydrogens are replaced
by fluorine (hence the FCSs are
‘‘perfluorinated’’). The toxicological
profile of extended perfluorinated alkyl
chains varies with chain length: On a
general basis, those with extended
perfluorinated alkyl chains greater than
or equal to eight carbons in length
demonstrate biopersistence in chronic
feeding studies, while those with
extended perfluorinated alkyl chains
less than eight carbons in length do not
(Ref. 1). Biopersistence is defined as
persistence and accumulation of a
material in a biological tissue due to
preferential deposition of the material in
the tissue combined with resistance of
the material to removal from the tissue
by natural clearance mechanisms (Ref.
2). As such, compounds containing
extended perfluorinated alkyl chains are
often classified as long- (i.e., ≥ eight
carbons in length) or short-chain
perfluorinated compounds, with
implications for toxicology analysis
including consideration of
biopersistence. All three of the FCSs
contain extended perfluorinated alkyl
chains ≥ eight carbons in length and as
such are long-chain perfluorinated
compounds (PFCs).
The petition cites a 2010 FDA
comprehensive review memorandum on
the available literature for long-chain
PFCs (Ref. 3). This memorandum noted
that available data on long-chain
perfluorocarboxylic acids and
fluorotelomer alcohols, both of which
are subsets of long-chain PFCs,
demonstrate reproductive and
developmental toxicity in animal
models. The FDA memorandum
determined that, based on structural
similarity to long-chain
perfluorocarboxylic acids and
fluorotelomer alcohols, and in the
absence of contradictory data, data
demonstrating reproductive and
developmental toxicity for long-chain
perfluorocarboxylic acids and
fluorotelomer alcohols was applicable to
long-chain PFCs on a general basis. The
petition asserts that, as the three subject
FCSs are long-chain PFCs, the concern
for reproductive and developmental
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toxicity for long-chain PFCs as
determined in FDA’s 2010
comprehensive review memorandum is
applicable to these three FCSs. The
petition also provides the results of an
updated comprehensive literature
search, which the petition asserts
reinforces the concern for reproductive
and developmental toxicity for longchain PFCs. The petition also asserts
that the updated literature search did
not discover any information which
would contradict FDA’s 2010
determination that data demonstrating
reproductive and developmental
toxicity for long-chain
perfluorocarboxylic acids and
fluorotelomer alcohols was applicable to
long-chain PFCs on a general basis.
Upon review of the available
information, FDA has confirmed our
2010 determination that data
demonstrating reproductive and
developmental toxicity for long-chain
perfluorocarboxylic acids and
fluorotelomer alcohols are applicable to
long-chain PFCs on a general basis (Ref.
4). FDA’s updated review noted that
there are no available toxicological
studies conducted with the three FCSs
that address the endpoints of
reproductive or developmental toxicity.
As all three FCSs are long-chain PFCs,
and in the absence of data specific to the
three FCSs to address these endpoints,
FDA utilized the available data
demonstrating reproductive and
developmental toxicity for long-chain
perfluorocarboxylic acids and
fluorotelomer alcohols to assess the
safety of the approved food-contact use
of the FCSs. FDA’s updated review
noted deficiencies in the available
information used to determine
migration of the FCSs into food as a
result of their approved food-contact use
(Ref. 5). For this reason FDA was unable
to calculate consumer exposure to the
FCSs in a manner which would allow a
quantitative assessment of the safety of
that exposure in the context of the
available data demonstrating
reproductive and developmental
toxicity for long-chain
perfluorocarboxylic acids and
fluorotelomer alcohols. However, FDA’s
review noted that available data
demonstrate that long-chain
perfluorocarboxylic acids and
fluorotelomer alcohols biopersist in
animals and that this biopersistence also
occurs in humans (Ref. 4). Although
available migration information does
not allow a quantitative assessment of
the safety of exposure to these FCSs, the
reproductive and development toxicity
of the three FCSs can be qualitatively
assessed in the context of biopersistence
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and the expectation that chronic dietary
exposure to these FCSs would result in
a systemic exposure to the FCSs or their
metabolic by-products at levels higher
than their daily dietary exposure (Ref.
4).
III. Comments on the Filing Notice
We received very few comments on
the petition. These comments stated that
the use of the three FCSs as listed in
§ 176.170 has been abandoned.
The basis for the action requested in
the petition is that new data are
available as to the toxicity of substances
structurally similar to the subject FCSs
that justify amending § 176.170. The
petition is not based on abandonment of
the approved food contact use of these
three FCSs. We have made a
determination that the information
provided in the petition and other
publicly available relevant data
demonstrates that there is no longer a
reasonable certainty of no harm for the
food contact use of the three FCS.
IV. Conclusion
We reviewed the data and information
in the petition and other available
relevant material to evaluate whether
new data are available as to the toxicity
of the subject FCSs that justify
amendment of § 176.170. As a result of
this review, we concluded that data for
subsets of long-chain PFCs
(demonstrating biopersistence and
reproductive and developmental
toxicity) are applicable to long-chain
PFCs on a general basis and that this
data raises significant questions as to
the safety of the authorized uses of the
three FCSs subject to the petition (Ref.
4). We also concluded that there is a
lack of data specific to the three subject
FCSs subject to the petition to address
these questions (Ref. 4). For these
reasons, in the absence of data specific
to the three FCSs to address
reproductive and developmental
toxicity, adequate migration data to
determine dietary exposure to the FCSs
from the food-contact use, and sufficient
data to account for a consumer’s
systemic exposure resulting from
chronic dietary exposure to these FCSs,
we conclude that there is no longer a
reasonable certainty of no harm for the
food contact use of these FCSs.
Therefore, we are amending part 176 as
set forth in this document. Upon the
effective date (see DATES), these food
additive uses are no longer authorized.
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
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be made available for public disclosure
(see FOR FURTHER INFORMATION CONTACT).
As provided in § 171.1(h), we will
delete from the documents any
materials that are not available for
public disclosure.
VI. Environmental Impact
We have considered the
environmental effects of this rule. As
stated in the March 16, 2015, Federal
Register notice of petition for FAP
4B4809 (80 FR 13508), we have
determined, under 21 CFR 25.15(c), 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, as set forth in 21 CFR
25.32(m). 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.
received or lack thereof in the Federal
Register.
IX. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and are available for viewing by
interested persons between 9 a.m. and 4
p.m., Monday through Friday; they are
also available electronically 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 subject to
change over time.
1. Rice, P.A. ‘‘C6-Perfluorinated
Compounds: The New Greaseproofing Agents
in Food Packaging,’’ Current Environmental
Health Reports, 2:1, pp. 33–40, 2015.
2. International Agency for Research on
Cancer, https://monographs.iarc.fr/ENG/
Monographs/vol81/mono81–8.pdf.
3. FDA Memorandum from P. Rice to P.
Honigfort, September 30, 2010.
4. FDA Memorandum from P. Rice to P.
Honigfort, July 27, 2015.
5. FDA Memorandum from J. Cooper to P.
Honigfort, July 23, 2015.
List of Subjects in 21 CFR Part 176
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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. We will publish
notice of the objections that we have
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Food additives, Food packaging.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and re-delegated to
the Director, Center for Food Safety and
Applied Nutrition, 21 CFR part 176 is
amended as follows:
PART 176—INDIRECT FOOD
ADDITIVES: PAPER AND
PAPERBOARD COMPONENTS
1. The authority citation for 21 CFR
part 176 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 346, 348,
379e.
§ 176.170
[Amended]
2. Amend § 176.170 in the table in
paragraph (a)(5) by removing the entries
for ‘‘Diethanolamine salts of mono- and
bis,’’ ‘‘Pentanoic acid,’’ and
‘‘Perfluoroalkyl substituted phosphate
ester acids.’’
■
Dated: December 29, 2015.
Susan Bernard,
Director, Office of Regulations, Policy and
Social Sciences, Center for Food Safety and
Applied Nutrition.
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DEPARTMENT OF DEFENSE
Department of the Navy
32 CFR Part 706
Certifications and Exemptions Under
the International Regulations for
Preventing Collisions at Sea, 1972
Department of the Navy, DoD.
Final rule.
AGENCY:
ACTION:
The Department of the Navy
(DoN) is amending its certifications and
exemptions under the International
Regulations for Preventing Collisions at
Sea, 1972, as amended (72 COLREGS),
to reflect that the Deputy Assistant
Judge Advocate General
(DAJAG)(Admiralty and Maritime Law)
has determined that USS ZUMWALT
(DDG 1000) is a vessel of the Navy
which, due to its special construction
and purpose, cannot fully comply with
certain provisions of the 72 COLREGS
without interfering with its special
function as a naval ship. The intended
effect of this rule is to warn mariners in
waters where 72 COLREGS apply.
DATES: This rule is effective January 4,
2016 and is applicable beginning
November 18, 2015.
FOR FURTHER INFORMATION CONTACT:
Commander Theron R. Korsak,
(Admiralty and Maritime Law), Office of
the Judge Advocate General, Department
of the Navy, 1322 Patterson Ave. SE.,
Suite 3000, Washington Navy Yard, DC
20374–5066, telephone 202–685–5040.
SUPPLEMENTARY INFORMATION: Pursuant
to the authority granted in 33 U.S.C.
1605, the DoN amends 32 CFR part 706.
This amendment provides notice that
the DAJAG (Admiralty and Maritime
Law), under authority delegated by the
Secretary of the Navy, has certified that
USS ZUMWALT (DDG 1000) is a vessel
of the Navy which, due to its special
construction and purpose, cannot fully
comply with the following specific
provisions of 72 COLREGS without
interfering with its special function as a
naval ship: Annex I paragraph 2 (a)(i),
pertaining to the location of the forward
masthead light at a height not less than
6 meters above the hull; Annex I,
paragraph 2(g) pertaining to the
placement of sidelights above the hull of
the vessel; Annex I, paragraph 2(i)(iii),
pertaining to the equally spaced vertical
separation of three task lights; and
Annex I, paragraph 2(k) as described in
Rule 30 (a)(i), pertaining to the vertical
separation between anchor lights, and
the location of the forward anchor light
at a height of not less than 6 meters
above the hull; Annex I, paragraph 3(a),
pertaining to the location of the forward
SUMMARY:
E:\FR\FM\04JAR1.SGM
04JAR1
]]>Agencies
[Federal Register Volume 81, Number 1 (Monday, January 4, 2016)]
[Rules and Regulations]
[Pages 5-8]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-33026]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 176
[Docket No. FDA-2015-F-0714]
Indirect Food Additives: Paper and Paperboard Components
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 three
specific perfluoroalkyl ethyl containing food-contact substances (FCSs)
as oil and water repellants for paper and paperboard for use in contact
with aqueous and fatty foods because new data are available as to the
toxicity of substances structurally similar to these compounds that
demonstrate there is no longer a reasonable certainty of no harm from
the food-contact use of these FCSs. This action is in response to a
petition filed by the Natural Resources Defense Council, the Center for
Food Safety, the Breast Cancer Fund, the Center for Environmental
Health, Clean Water Action, the Center for Science in the Public
Interest, Children's Environmental Health Network, Environmental
Working Group, and Improving Kids' Environment.
DATES: This rule is effective January 4, 2016. Submit either electronic
or written objections and requests for a hearing by February 3, 2016.
See section VIII for further information on the filing of objections.
ADDRESSES: You may submit objections and requests for a hearing as
follows:
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 in the following way:
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-
[[Page 6]]
2015-F-0714 for ``Indirect Food Additives: Paper and Paperboard
Components.'' Received objections 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.'' 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 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.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 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: Paul Honigfort, Center for Food Safety
and Applied Nutrition (HFS-275), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1206.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register on March 16, 2015 (80
FR 13508), we announced that we filed a food additive petition (FAP
4B4809) submitted by the Natural Resources Defense Council, 1152 15th
St. NW., Suite 300, Washington, DC 20005; the Center for Food Safety,
303 Sacramento St., Second Floor, San Francisco, CA 94111; Clean Water
Action, 1444 Eye St. NW., Suite 400, Washington, DC 20005; the Center
for Science in the Public Interest, 1220 L St. NW., Suite 300,
Washington, DC 20005; Children's Environmental Health Network, 110
Maryland Ave. NE., Suite 404, Washington, DC 20002; the Breast Cancer
Fund, 1388 Sutter St., Suite 400, San Francisco, CA 94109-5400; the
Center for Environmental Health, 2201 Broadway, Suite 302, Oakland, CA
94612; Environmental Working Group, 1436 U St. NW., Suite 100,
Washington, DC 20009; and Improving Kids' Environment, 1915 West 18th
St., Indianapolis, IN 46202.
The petition proposed to amend Sec. 176.170 (21 CFR 176.170) to no
longer provide for the use of three perfluoroalkyl ethyl containing
FCSs as oil and water repellants for paper and paperboard for use in
contact with aqueous and fatty foods. The three FCSs which are the
subjects of this petition are as follows:
1. Diethanolamine salts of mono- and bis (1H,1H,2H,2H
perfluoroalkyl) phosphates where the alkyl group is even-numbered in
the range C8-C18 and the salts have a fluorine content of 52.4
percent to 54.4 percent as determined on a solids basis;
2. Pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20-
alkyl)thio] derivatives, compounds with diethanolamine (CAS Reg. No.
71608-61-2); and
3. Perfluoroalkyl substituted phosphate ester acids, ammonium
salts formed by the reaction of 2,2-bis[([gamma], [omega]-perfluoro
C4-20 alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and
ammonium hydroxide.
II. Evaluation of Safety
The three subject FCSs are regulated as food additives under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act). Section 409 of the
FD&C Act (21 U.S.C. 348) sets forth the statutory requirements for food
additives. Section 201(s) of the FD&C Act (21 U.S.C. 321(s)) includes
substances intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food among the substances defined as food additives, provided the
intended use results or may reasonably be expected to result in it
becoming a component of food and those uses were not sanctioned prior
to 1958 or are not generally recognized as safe among experts qualified
by scientific training and experience to evaluate its safety.
Under section 402(a)(2)(c)(1) of the FD&C Act (21 U.S.C.
342(a)(2)(c)(1)), food shall be deemed to be adulterated if it is or if
it bears or contains any food additive that is unsafe within the
meaning of section 409 of the FD&C Act. A food additive shall be deemed
to be unsafe under section 409 of the FD&C Act, in relevant part,
unless its use conforms to a food additive regulation or an effective
food contact notification. Section 409(i) of the FD&C Act states that
the procedure for amending or repealing a regulation shall conform to
the procedure for the promulgation of such regulations. FDA's
regulations specific to the administrative actions for food additives
provide that the Commissioner, either 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 appeal. New data must be furnished in the
form specified in Sec. 171.1 (21 CFR 171.1) and 21 CFR 171.100 for
submitting petitions (see Sec. 171.130(b)). Under these regulations, a
petitioner may propose that we amend a food additive regulation if the
petitioner can demonstrate that new data are available as to the
toxicity of the food additive that may justify amendment of the food
additive regulation.
Under section 409(c)(3) of the FD&C Act we will not establish a
regulation for the use of a food additive if a fair evaluation of the
data fails to establish that the proposed use of the food additive,
under the conditions of use to be specified in the regulation, will be
safe. Our regulations, at 21 CFR 170.3(h)(i), define safety as ``a
reasonable certainty in the minds of competent scientists that the
substance is not harmful under the intended conditions of use.'' In
order for FDA to grant a petition that seeks an amendment to a food
additive regulation based upon new data concerning the toxicity of the
food additive, such data must be adequate for FDA to conclude that
there is no longer
[[Page 7]]
a reasonable certainty of no harm for the intended use of the
substance.
The petition asserts that publically available information on long-
chain perfluorinated compounds as a chemical class, which has become
available after the food contact use of the three FCSs was approved,
demonstrates that there is no longer a reasonable certainty of no harm
from the food contact use of the three FCSs as listed in Sec. 176.170.
All three of the FCSs subject to the petition contain extended
alkyl chains where all of the hydrogens are replaced by fluorine (hence
the FCSs are ``perfluorinated''). The toxicological profile of extended
perfluorinated alkyl chains varies with chain length: On a general
basis, those with extended perfluorinated alkyl chains greater than or
equal to eight carbons in length demonstrate biopersistence in chronic
feeding studies, while those with extended perfluorinated alkyl chains
less than eight carbons in length do not (Ref. 1). Biopersistence is
defined as persistence and accumulation of a material in a biological
tissue due to preferential deposition of the material in the tissue
combined with resistance of the material to removal from the tissue by
natural clearance mechanisms (Ref. 2). As such, compounds containing
extended perfluorinated alkyl chains are often classified as long-
(i.e., >= eight carbons in length) or short-chain perfluorinated
compounds, with implications for toxicology analysis including
consideration of biopersistence. All three of the FCSs contain extended
perfluorinated alkyl chains >= eight carbons in length and as such are
long-chain perfluorinated compounds (PFCs).
The petition cites a 2010 FDA comprehensive review memorandum on
the available literature for long-chain PFCs (Ref. 3). This memorandum
noted that available data on long-chain perfluorocarboxylic acids and
fluorotelomer alcohols, both of which are subsets of long-chain PFCs,
demonstrate reproductive and developmental toxicity in animal models.
The FDA memorandum determined that, based on structural similarity to
long-chain perfluorocarboxylic acids and fluorotelomer alcohols, and in
the absence of contradictory data, data demonstrating reproductive and
developmental toxicity for long-chain perfluorocarboxylic acids and
fluorotelomer alcohols was applicable to long-chain PFCs on a general
basis. The petition asserts that, as the three subject FCSs are long-
chain PFCs, the concern for reproductive and developmental toxicity for
long-chain PFCs as determined in FDA's 2010 comprehensive review
memorandum is applicable to these three FCSs. The petition also
provides the results of an updated comprehensive literature search,
which the petition asserts reinforces the concern for reproductive and
developmental toxicity for long-chain PFCs. The petition also asserts
that the updated literature search did not discover any information
which would contradict FDA's 2010 determination that data demonstrating
reproductive and developmental toxicity for long-chain
perfluorocarboxylic acids and fluorotelomer alcohols was applicable to
long-chain PFCs on a general basis.
Upon review of the available information, FDA has confirmed our
2010 determination that data demonstrating reproductive and
developmental toxicity for long-chain perfluorocarboxylic acids and
fluorotelomer alcohols are applicable to long-chain PFCs on a general
basis (Ref. 4). FDA's updated review noted that there are no available
toxicological studies conducted with the three FCSs that address the
endpoints of reproductive or developmental toxicity. As all three FCSs
are long-chain PFCs, and in the absence of data specific to the three
FCSs to address these endpoints, FDA utilized the available data
demonstrating reproductive and developmental toxicity for long-chain
perfluorocarboxylic acids and fluorotelomer alcohols to assess the
safety of the approved food-contact use of the FCSs. FDA's updated
review noted deficiencies in the available information used to
determine migration of the FCSs into food as a result of their approved
food-contact use (Ref. 5). For this reason FDA was unable to calculate
consumer exposure to the FCSs in a manner which would allow a
quantitative assessment of the safety of that exposure in the context
of the available data demonstrating reproductive and developmental
toxicity for long-chain perfluorocarboxylic acids and fluorotelomer
alcohols. However, FDA's review noted that available data demonstrate
that long-chain perfluorocarboxylic acids and fluorotelomer alcohols
biopersist in animals and that this biopersistence also occurs in
humans (Ref. 4). Although available migration information does not
allow a quantitative assessment of the safety of exposure to these
FCSs, the reproductive and development toxicity of the three FCSs can
be qualitatively assessed in the context of biopersistence and the
expectation that chronic dietary exposure to these FCSs would result in
a systemic exposure to the FCSs or their metabolic by-products at
levels higher than their daily dietary exposure (Ref. 4).
III. Comments on the Filing Notice
We received very few comments on the petition. These comments
stated that the use of the three FCSs as listed in Sec. 176.170 has
been abandoned.
The basis for the action requested in the petition is that new data
are available as to the toxicity of substances structurally similar to
the subject FCSs that justify amending Sec. 176.170. The petition is
not based on abandonment of the approved food contact use of these
three FCSs. We have made a determination that the information provided
in the petition and other publicly available relevant data demonstrates
that there is no longer a reasonable certainty of no harm for the food
contact use of the three FCS.
IV. Conclusion
We reviewed the data and information in the petition and other
available relevant material to evaluate whether new data are available
as to the toxicity of the subject FCSs that justify amendment of Sec.
176.170. As a result of this review, we concluded that data for subsets
of long-chain PFCs (demonstrating biopersistence and reproductive and
developmental toxicity) are applicable to long-chain PFCs on a general
basis and that this data raises significant questions as to the safety
of the authorized uses of the three FCSs subject to the petition (Ref.
4). We also concluded that there is a lack of data specific to the
three subject FCSs subject to the petition to address these questions
(Ref. 4). For these reasons, in the absence of data specific to the
three FCSs to address reproductive and developmental toxicity, adequate
migration data to determine dietary exposure to the FCSs from the food-
contact use, and sufficient data to account for a consumer's systemic
exposure resulting from chronic dietary exposure to these FCSs, we
conclude that there is no longer a reasonable certainty of no harm for
the food contact use of these FCSs. Therefore, we are amending part 176
as set forth in this document. Upon the effective date (see DATES),
these food additive uses are no longer authorized.
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
[[Page 8]]
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 materials that are not available for public disclosure.
VI. Environmental Impact
We have considered the environmental effects of this rule. As
stated in the March 16, 2015, Federal Register notice of petition for
FAP 4B4809 (80 FR 13508), we have determined, under 21 CFR 25.15(c),
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, as set forth in 21 CFR 25.32(m). 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. We will publish notice of the objections that we
have received or lack thereof in the Federal Register.
IX. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically 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
subject to change over time.
1. Rice, P.A. ``C6-Perfluorinated Compounds: The New
Greaseproofing Agents in Food Packaging,'' Current Environmental
Health Reports, 2:1, pp. 33-40, 2015.
2. International Agency for Research on Cancer, https://monographs.iarc.fr/ENG/Monographs/vol81/mono81-8.pdf.
3. FDA Memorandum from P. Rice to P. Honigfort, September 30,
2010.
4. FDA Memorandum from P. Rice to P. Honigfort, July 27, 2015.
5. FDA Memorandum from J. Cooper to P. Honigfort, July 23, 2015.
List of Subjects in 21 CFR Part 176
Food additives, Food packaging.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and re-
delegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 176 is amended as follows:
PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
0
1. The authority citation for 21 CFR part 176 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 346, 348, 379e.
Sec. 176.170 [Amended]
0
2. Amend Sec. 176.170 in the table in paragraph (a)(5) by removing the
entries for ``Diethanolamine salts of mono- and bis,'' ``Pentanoic
acid,'' and ``Perfluoroalkyl substituted phosphate ester acids.''
Dated: December 29, 2015.
Susan Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2015-33026 Filed 12-31-15; 8:45 am]
BILLING CODE 4164-01-P
