Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule, 2885-2898 [2015-00636]
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TABLE 2 TO SUBPART JJJJJJ OF PART 63—WORK PRACTICE STANDARDS, EMISSION REDUCTION MEASURES, AND
MANAGEMENT PRACTICES—Continued
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*
*
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If your boiler is in this subcategory . . .
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You must meet the following . . .
(6) A list of the energy savings potential of the energy conservation measures identified, and
(7) A comprehensive report detailing the ways to improve efficiency, the cost of specific improvements, benefits, and the time
frame for recouping those investments.
14. Table 6 to subpart JJJJJJ is amended
by revising the entry for ‘‘2.’’ to read as
follows:
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TABLE 6 TO SUBPART JJJJJJ OF PART 63—ESTABLISHING OPERATING LIMITS
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If you have an applicable emission
limit for . . .
And your operating limits are
based on . . .
You must . . .
Using . . .
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2. Mercury ............
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Dry sorbent or
activated carbon injection
rate operating
parameters.
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Establish a site-specific minimum
sorbent or activated carbon injection rate operating limit according to § 63.11211(b).
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Data from the sorbent or activated carbon injection rate
monitors and the mercury performance stack tests.
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[FR Doc. 2014–30388 Filed 1–20–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2013–0225; FRL–9915–63]
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RIN 2070–AJ99
Long-Chain Perfluoroalkyl Carboxylate
and Perfluoroalkyl Sulfonate Chemical
Substances; Significant New Use Rule
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
Under the Toxic Substances
Control Act (TSCA), EPA is proposing to
SUMMARY:
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According to the following
requirements
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amend a significant new use rule
(SNUR) for long-chain perfluoroalkyl
carboxylate (LCPFAC) chemical
substances by designating as a
significant new use manufacturing
(including importing) or processing of
an identified subset of LCPFAC
chemical substances for any use that
will not be ongoing after December 31,
2015, and all other LCPFAC chemicals
substances for which there are currently
no ongoing uses. For this SNUR, EPA is
also proposing to make inapplicable the
exemption for persons who import
LCPFAC chemical substances as part of
articles. In addition, EPA is also
proposing to amend a SNUR for
perfluoroalkyl sulfonate (PFAS)
chemical substances that would make
inapplicable the exemption for persons
who import PFAS chemical substances
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(a) You must collect sorbent or
activated carbon injection rate
data every 15 minutes during
the entire period of the performance stack tests;
(b) Determine the average sorbent or activated carbon injection rate for each individual
test run in the three-run performance stack test by computing the average of all the
15-minute readings taken during each test run.
(c) When your unit operates at
lower loads, multiply your sorbent or activated carbon injection rate by the load fraction,
as defined in § 63.11237, to
determine the required injection rate.
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*
as part of carpets. Persons subject to
these SNURs would be required to
notify EPA at least 90 days before
commencing such manufacture or
processing. The required notifications
would provide EPA with the
opportunity to evaluate the intended
use and, if necessary, an opportunity to
protect against potential unreasonable
risks from that activity before it occurs.
DATES: Comments must be received on
or before March 23, 2015.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2013–0225, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
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Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Nicholas Nairn-Birch, Chemical Control
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001;
telephone number: (202) 564–3668;
email address: nairn-birch.nicholas@
epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
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A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture
(including import) or process any of the
chemical substances covered by this
proposed SNUR. The North American
Industrial Classification System
(NAICS) codes that are identified in this
unit are not intended to be exhaustive,
but rather provides a guide to help
readers determine whether this rule
applies to them. Potentially affected
entities may include:
• Manufacturers (including
importers) of one or more of subject
chemical substances (NAICS codes 325
and 324110); e.g., chemical
manufacturing and petroleum refineries.
• Fiber, yarn, and thread mills
(NAICS code 31311).
• Carpet and rug mills (NAICS code
314110).
• Home furnishing merchant
wholesalers (NAICS code 423220).
• Carpet and upholstery cleaning
services (NAICS code 561740).
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This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Persons who import
any chemical substance governed by a
final SNUR are subject to the TSCA
section 13 (15 U.S.C. 2612) import
certification requirements and the
corresponding regulations at 19 CFR
12.118 through 12.127; see also 19 CFR
127.28. Those persons must certify that
the shipment of the chemical substance
complies with all applicable rules and
orders under TSCA, including any
SNUR requirements. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, any persons who export or
intend to export a chemical substance
that is the subject of this proposed rule
on or after February 20, 2015 are subject
to the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b)),
(see 40 CFR 721.20), and must comply
with the export notification
requirements in 40 CFR part 707,
subpart D.
To determine whether you or your
business may be affected by this action,
you should carefully examine the
applicability provisions in 40 CFR 721.5
and 40 CFR 721.9582. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the technical person listed under FOR
FURTHER INFORMATION CONTACT.
B. What is the agency’s authority for
taking this action?
Section 5(a)(2) of TSCA (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including those listed in TSCA section
5(a)(2). Once EPA determines that a use
of a chemical substance is a significant
new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant
new use notice (SNUN) to EPA at least
90 days before they manufacture or
process the chemical substance for that
use (15 U.S.C. 2604(a)(1)(B)). As
described in Unit V., the general SNUR
provisions are found at 40 CFR part 721,
subpart A.
C. What action is the Agency taking?
EPA is proposing to amend a SNUR
at 40 CFR 721.10536 for LCPFAC
chemical substances by designating
manufacturing (including importing) or
processing of LCPFAC chemical
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substances listed in Table 1 of this unit
for any use that is no longer ongoing
after December 31, 2015, as a significant
new use; designating manufacturing
(including importing) or processing of
PFOA or its salts for any use as a
significant new use; and designating
manufacturing (including importing) or
processing of all other LCPFAC
chemical substances for any use not
ongoing as of the date on which this
proposed rule is published as a
significant new use. For this SNUR, EPA
is also proposing to make the exemption
at 40 CFR 721.45(f) inapplicable for
persons who import LCPFAC chemical
substances listed in Table 1 of this unit
and PFOA or its salts as part of articles
because exposure would increase if in
the future LCPFAC chemical substances,
including PFOA, are incorporated in
articles and then imported. EPA is also
proposing to amend a SNUR at 40 CFR
721.9582 for PFAS chemical substances
to make the exemption at 40 CFR
721.45(f) inapplicable for persons who
import of PFAS chemical substances as
part of carpets. This action is consistent
with the purpose of the ‘‘Long-Chain
Perfluorinated Chemicals Action Plan’’
(2009 Action Plan) published on
December 30, 2009 (Ref. 1). EPA is
continuing to assess these chemical
substances to determine what other
actions would be warranted. Before
promulgating a final SNUR with respect
to uses of LCPFAC chemical substances
listed in Table 1 of this unit that are
now ongoing, but are expected to be
phased out by December 31, 2015, EPA
will verify through comments on this
action, or by other means, that the
proposed significant new uses have
indeed ceased. Similarly, before
promulgating a final SNUR on LCPFAC
chemical substances other than those
listed in Table 1 of this unit, EPA will
determine based on comments on this
action and other means what if any uses
are ongoing in making significant new
use determinations in the final rule.
Persons would be required to notify
EPA at least 90 days before commencing
manufacture or processing of LCPFAC
chemical substances for the designated
significant new uses. This proposed
SNUR is intended to follow and codify
an existing voluntary industry
commitment to phase out LCPFAC
chemical substances by the end of 2015
(Ref. 2). The objectives and rationale for
this proposed SNUR are explained in
more detail in Unit III.
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TABLE 1—LCPFAC CHEMICAL SUBSTANCES SUBJECT TO REPORTING AFTER DECEMBER 31, 2015
CAS registry
No. (CASRN)
Accession CAS No.
Accession
Accession
Accession
Accession
Accession
Accession
Accession
Accession
Accession
Accession
Number
Number
Number
Number
Number
Number
Number
Number
Number
Number
Chemical name
507–63–1 .......
678–39–7 .......
865–86–1 .......
2043–53–0 .....
2043–54–1 .....
17741–60–5 ...
27905–45–9 ...
30046–31–2 ...
39239–77–5 ...
60699–51–6 ...
No
No
No
No
No
No
No
No
No
No
...
...
...
...
...
...
...
...
...
...
65510–55–6 ...
No Accession Number ...
68187–47–3 ...
No Accession Number ...
68391–08–2 ...
70969–47–0 ...
125476–71–3
No Accession Number ...
No Accession Number ...
No Accession Number ...
1078712–88–5
1078715–61–3
No Accession Number ...
No Accession Number ...
CBI .................
CBI .................
CBI .................
Octane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-heptadecafluoro-8-iodo-.
1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoro-.
1-Dodecanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,12-heneicosafluoro-.
Decane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-heptadecafluoro-10-iodo-.
Dodecane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10-heneicosafluoro-12-iodo-.
2-Propenoic acid, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11, 12,12,12-heneicosafluorododecyl ester.
2-Propenoic acid, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl ester.
Tetradecane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12-pentacosafluoro-14-iodo-.
1-Tetradecanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,14-pentacosafluoro-.
1-Hexadecanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,16nonacosafluoro-.
Hexadecane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14-nonacosafluoro-16iodo-.
1-Propanesulfonic acid, 2-methyl-, 2-[[1-oxo-3-[(.gamma.-.omega.-perfluoro- C4-16alkyl)thio]propyl]amino] derivs., sodium salts.
Alcohols, C8-14, .gamma.-.omega.-perfluoro.
Thiols, C8-20, .gamma.-.omega.-perfluoro, telomers with acrylamide.
Silicic acid (H4SiO4), sodium salt (1:2), reaction products with chlorotrimethylsilane and
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoro-1-decanol.
Thiols, C4-20, .gamma.-.omega.-perfluoro, telomers with acrylamide and acrylic acid, sodium salts.
1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-[2-[(.gamma.-.omega.-perfluoro-C420-a lkyl)thio]acetyl] derivs., inner salts.
Polyfluoroalkyl betaine.
Modified fluoroalkyl urethane.
Perfluorinated polyamine.
71217 .............................
89419 .............................
274147 ...........................
CBI = Confidential Business Information. CAS or CASRN = Chemical Abstracts Service Registry Number.
In this proposed rule, the term
LCPFAC refers to the long-chain
category of perfluorinated carboxylate
chemical substances with perfluorinated
carbon chain lengths equal to or greater
than seven carbons and less than or
equal to 20 carbons. The category of
LCPFAC chemical substances also
includes the salts and precursors of
these perfluorinated carboxylates. See
Unit II.A. for the specific definition of
the LCPFAC category.
PFOA and its salts are subject to this
proposed rule. PFOA and examples of
PFOA salts with Chemical Abstract
Service Registry Numbers (CASRN) and
chemical names are shown in Table 2 of
this unit. PFOA and its salts are
considered LCPFAC chemical
substances. EPA believes all uses of
PFOA and its salts were phased out by
December 31, 2013.
TABLE 2—PFOA AND EXAMPLES OF
ITS SALTS
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CAS registry
No. (CASRN)
335–66–0 .....
335–67–1 .....
335–93–3 .....
335–95–5 .....
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Chemical name
Octanoyl fluoride,
pentadecafluoro-.
Octanoic acid,
pentadecafluoro- (PFOA).
Octanoic acid,
pentadecafluoro-, silver
salt.
Octanoic acid,
pentadecafluoro-, sodium
salt.
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TABLE 2—PFOA AND EXAMPLES OF
ITS SALTS—Continued
CAS registry
No. (CASRN)
2395–00–8 ...
3825–26–1 ...
Chemical name
Octanoic acid,
pentadecafluoro-, potassium salt.
Octanoic acid,
pentadecafluoro-, ammonium salt (APFO).
CAS or CASRN = Chemical Abstracts Service Registry Number.
The PFAS chemical substances for
which EPA is modifying an existing
SNUR are currently listed in 40 CFR
721.9582(a)(1). All of these chemical
substances are collectively referred to in
this rule as perfluoroalkyl sulfonates, or
PFAS chemical substances. In this
proposal, the term PFAS refers to a
category of perfluorinated sulfonate
chemical substances of any chain
length.
EPA will not designate ongoing uses
as significant new uses when the final
rule is promulgated, except for uses that
will be phased out by the end of 2015.
Persons who manufacture (including
importers) or process any of the
chemical substances included in the
proposed SNUR for an ongoing use at
the time this proposed rule is published
would be free to continue without
submitting a SNUN. Note, however, that
uses not already ongoing as of the
publication date of this proposed rule,
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and ongoing uses that will be phased
out by the end of 2015, would not be
considered ongoing uses if they later
arise, even if they are in existence upon
the issuance of a final rule.
Furthermore, uses that are ongoing as of
the publication date of this proposed
rule would not be considered ongoing
uses if they have ceased by the date of
issuance of a final rule (see Units IV.
and VI. for further discussion of what
constitutes an ongoing use). Persons
who intend to begin or resume
commercial manufacture or processing
of the chemical substance(s) for a
significant new use would have to
comply with all applicable SNUN
requirements.
The LCPFAC chemical substances
identified in Table 1 of this unit are
known to have current or recent ongoing
uses on the basis of their inclusion in
reports submitted to the Agency under
the 2012 Chemical Data Reporting (CDR)
rule. EPA particularly requests comment
on whether any of the current uses of
any of the specific chemical substances
identified in Table 1 of this unit will
continue to be ongoing after December
31, 2015. EPA also requests comment on
whether there are currently any ongoing
uses, including use as part of articles, of
any of the remaining LCPFAC chemical
substances that were not identified
during the 2012 CDR. Furthermore, EPA
requests comment on whether there are
any ongoing uses of PFOA or its salts,
and whether PFAS chemical substances
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are currently imported as part of
carpets. EPA would welcome specific
documentation of any such ongoing use.
D. Why is the Agency taking this action?
These SNURs are necessary to ensure
that EPA receives timely advance notice
of any future manufacturing (including
importing) and processing of these
LCPFAC chemical substances for new
uses that may produce changes in
human and environmental exposures.
The rationale and objectives for this
SNUR are explained in Unit III.
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E. What are the estimated incremental
impacts of this action?
EPA has evaluated the potential costs
of establishing SNUR reporting
requirements for potential
manufacturers (including importers)
and processors of the chemical
substances included in this proposed
rule. The economic analysis, which is
available in the docket, is discussed in
Unit IX., and is briefly summarized
here.
In the event that a SNUN is
submitted, costs are estimated to be less
than $8,589 per SNUN submission for
large business submitters and $6,189 for
small business submitters. These
estimates include the cost to prepare
and submit the SNUN and the payment
of a user fee. In addition, for persons
exporting a chemical substance that is
the subject of a SNUR, a one-time notice
must be provided for the first export or
intended export to a particular country,
which is estimated to cost less than
$100 on average per notification. The
proposed rule may also affect firms that
plan to import articles that contain
LCFPAC chemical substances, because,
while not required by the SNUR, these
parties may take additional steps to
determine whether LCPFAC chemical
substances are part of the articles that
they are considering to import. In the
accompanying Economic Analysis for
this proposed SNUR, example steps
(and their respective costs) that an
importer might take to identify LCPFAC
chemicals in articles are provided.
These can include gathering information
through agreements with suppliers,
declarations through databases or
surveys, or use of a third party
certification system. Additionally,
importers may require suppliers to
provide certificates of testing analysis of
the products or perform their own
laboratory testing of certain articles.
EPA is unable to predict, however,
what, if any, particular steps an
importer might take; potential total costs
were not estimated.
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II. Chemical Substances Subject to This
Proposed Rule
CFR 721.10536(b)(4)(i) through
(b)(4)(iv).
A. What LCPFAC chemical substances
are subject to this proposed SNUR?
B. What PFAS chemical substances are
subject to this proposed SNUR?
PFAS refers to a category of
perfluorinated sulfonate chemical
substances of any chain length. The
PFAS chemical substances for which
EPA is proposing to modify an existing
SNUR are currently listed in 40 CFR
721.9582(a)(1).
LCPFAC chemical substances are
synthetic chemicals that do not occur
naturally in the environment. The
LCPFAC chemical substances identified
in this unit, where 5 < n < 21 or 6 <
m < 21:
1. CF3(CF2)n-COO-M where M = H∂ or
any other group where a formal
dissociation can be made.;
2. CF3(CF2)n-CH=CH2.
3. CF3(CF2)n-C(=O)-X where X is any
chemical moiety.
4. CF3(CF2)m-CH2-X where X is any
chemical moiety.
5. CF3(CF2)m-Y–X where Y = non-S,
non-N heteroatom and where X is any
chemical moiety.
This category definition of LCPFAC
chemical substances, based on the
chemical structures in this unit, refers to
a group of chemical substances
containing PFOA and its higher
homologues. The category also includes
the salts and precursors of these
chemical substances. The precursors
may be simple derivatives of PFOA and
higher homologues or polymers that
contain or may degrade to PFOA or
higher homologues. These precursors
include long-chain fluorotelomers.
LCPFAC chemical substances with
greater than 20 perfluorinated carbons
can be considered polymers within the
polymer exemption under 40 CFR
723.250 because they exceed a
molecular weight of 1,000 daltons and
contain at least 3 monomer units. As it
is not EPA’s intent to regulate
fluoropolymers in this proposed rule,
the LCPFAC category in this proposed
rule includes a perfluorinated carbon
chain length upper limit of 20.
In this proposed rule, PFOA and its
salts includes the chemical substances
listed in Table 2 of Unit II. PFOA and
its salts are considered LCPFAC
chemical substances.
Under this proposed rule, any
LCPFAC chemical substance identified
by 40 CFR 721.10536(b)(1)(i) through
(b)(1)(v) that is intentionally used
during fluoropolymer formulation, such
as an emulsion stabilizer in aqueous
dispersions, would be subject to
reporting for the significant new uses
described in 40 CFR 721.10536(b)(4)(i)
through (b)(4)(iv). For example,
ammonium perfluorooctanoate
(APFO)—when used as an aqueous
dispersion agent in fluoropolymer
production—is subject to this SNUR if
the final fluoropolymer product is used
for a significant new use described in 40
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C. What are the uses and production
levels of LCPFAC chemical substances?
PFOA, a member of the LCPFAC
category, is a synthetic (man-made)
chemical that does not occur naturally
in the environment. PFOA is
manufactured for use primarily as an
aqueous dispersion agent as the
ammonium salt in the manufacture of
fluoropolymers. PFOA can also be
produced unintentionally by the
degradation of some fluorotelomers,
which are not manufactured using
PFOA but could degrade to PFOA.
DuPont, which was the last company to
manufacture (including import) PFOA
and its salts in the United States, ceased
all production (including import) of
PFOA and its salts in 2013 (Ref. 3).
Fluoropolymers provide nonstick
surfaces for cookware and other
products, are used as molded
automotive parts, and have many other
applications. Polytetrafluoroethylene
(PTFE) is the dominant fluoropolymer,
accounting for 58% (by weight) of world
fluoropolymer consumption in 2012
(Ref. 4). The United States accounted for
20% of the world consumption of PTFE
in 2012 and 40% of the world
consumption of other fluoropolymers.
Fluorotelomers, oligomers of
tetrafluoroethylene, are relatively small
functionalized molecules used to make
polymers and surfactants. World-wide
production of fluorotelomer-based
polymers (FTBP) was estimated at 20
million pounds in 2006. Fluorotelomer
monomers and FTBP are included in the
LCPFAC category definition as potential
LCPFAC precursors (Ref. 5). The United
States accounts for more than 50% of
world-wide fluorotelomer/FTPB
production. Textiles and apparel
account for approximately 50% of the
volume used (Ref. 1).
In January 2006, EPA launched the
2010/2015 PFOA Stewardship Program
(PFOA Stewardship Program) in
partnership with eight companies:
DuPont, Solvay Solexis, Asahi Glass
Company, Daikin America, Inc., Clariant
International Ltd., 3M/Dyneon, Arkema
Inc., and BASF (formerly Ciba Specialty
Chemicals Corporation) (Ref. 2). These
companies represent a majority of global
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manufacture of LCPFAC chemical
substances (Ref. 6). The program set a
goal of reducing facility emissions and
product content of LCPFAC chemical
substances on a global basis by 95%, no
later than 2010, and to eliminate
emissions and product content of these
chemical substances by 2015. With the
exception of one manufacturer who has
not participated in the PFOA
Stewardship Program, these companies
accounted for the total volume of
LCPFAC chemical substances reported
on the 2012 CDR (see Table 2 of Unit I.).
Since these chemical substances are
proprietary chemicals, they are not
expected to be manufactured by any
other company. The eight participating
companies have informed EPA that they
are on track to phase out LCPFAC
chemical substances by the end of 2015
(Ref. 7).
Based on the 2012 CDR, there was one
additional manufacturer of certain
LCPFAC chemical substances who has
not participated in the PFOA
Stewardship Program. This company
manufactures a small volume of
LCPFAC chemical substances,
compared to the volume of LCPFAC
chemical substances manufactured by
PFOA Stewardship Program companies,
and those chemicals are primarily used
in firefighting foams. This company has
expressed an interest in participating in
the phase out goal of the PFOA
Stewardship Program and has already
submitted premanufacture notices
(PMNs) for chemical substitutes of their
current LCPFAC chemical substances.
Other than the PFOA Stewardship
Program companies and this one
company, there were no other
companies that reported manufacture
(including import) of LCPFAC chemical
substances in the 2012 CDR. Any
domestic companies still manufacturing
LCPFAC chemical substances are most
likely obtaining the feedstocks for that
manufacturing process from companies
participating in the PFOA Stewardship
Program. For these companies to
continue manufacturing LCPFAC
chemical substances, they would need
the feedstock and finished LCPFAC
chemical substances currently supplied
by companies participating in the PFOA
Stewardship Program. As the PFOA
Stewardship Program member
companies phase out their manufacture
of those substances and customer
demand continues to shift from LCPFAC
chemical substances to alternatives,
EPA believes that the manufacture of
LCPFAC chemical substances by
companies not participating in the
PFOA Stewardship Programs are likely
to cease by December 31, 2015. EPA
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would like to receive comments
addressing the extent to which
companies manufacturing specific
LCPFAC chemical substances for
particular uses are utilizing existing
sources that are not dependent on the
PFOA Stewardship Program member
companies and that are expected to
continue after December 31, 2015.
Because specific uses of those specific
chemical substances would be
considered ongoing, they would be
outside the scope of the significant new
use when finalized.
D. What are the uses and production
levels of PFAS chemical substances?
The Agency previously determined
that the 271 PFAS chemical substances
identified in 40 CFR 721.9582(a)(1) were
no longer being manufactured for any
use in the United States, other than for
the uses listed under 40 CFR
721.9582(a)(3), (a)(4), and (a)(5) (Refs. 8
and 9). PFAS chemical substances
included in 40 CFR 721.9582 were
previously used in a variety of products,
which can be divided into three main
use categories: Surface treatments, paper
protection, and performance chemicals.
In the past, PFAS chemical substances
in the performance chemicals category
were used in a wide variety of
specialized industrial, commercial, and
consumer applications. Specific
applications included firefighting
foams, mining and oil well surfactants,
acid mist suppressants for metal plating
and electronic etching baths, alkaline
cleaners, floor polishes, inks,
photographic film, denture cleaners,
shampoos, chemical intermediates,
coating additives, carpet spot cleaners,
and as an insecticide in bait stations for
ants (Ref. 10). In some instances, PFAS
chemical substances are no longer used
for the uses listed in 40 CFR
721.9582(a)(3), (a)(4), and (a)(5) as a
result of new substitutes developed and
production and processing changes
implemented by companies to eliminate
the need for use of PFAS chemical
substances. In addition, since those
chemicals are no longer manufactured
(including imported) other than for the
listed uses, EPA believes that those
chemical substances are also no longer
processed other than for those listed
uses.
E. What are the potential health and
environmental effects of LCPFAC
chemical substances?
The following brief summary of
chemistry, environmental fate, exposure
pathways, and health and
environmental effects of LCPFAC
chemical substances is based on the
2009 Action Plan (Ref. 1), references
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cited in the 2009 Action Plan, and
additional selected references published
after the 2009 Action Plan.
PFOA is persistent, widely present in
humans and the environment, has long
half-lives in humans, and can cause
adverse effects in laboratory animals,
including cancer and developmental
and systemic toxicity (Refs. 11, 12, 13,
14, and 15). PFOA precursors,
chemicals which degrade or may
degrade to PFOA, are also present
worldwide in humans and the
environment and, in some cases, might
be present at higher concentrations than
PFOA and be more toxic (Refs. 16, 17,
18, 19, and 20). PFOA higher
homologues are chemicals with carbon
chain lengths longer than PFOA.
Available evidence suggests that toxicity
and bioaccumulation appear to be
higher for chemical substances with
longer carbon chain lengths compared
to those with shorter chain lengths
(Refs. 21, 22, 23, and 24).
LCPFAC chemical substances have
been detected in biota, air, water, dust,
and soil samples collected throughout
the world. Some LCPFAC chemical
substances have the potential for longrange transport. They are transported
over long distances by a combination of
dissolved-phase ocean and gas-phase
atmospheric transport; however,
determining which is the predominant
transport pathway is complicated by
many factors, including the uncertainty
over water to atmosphere partitioning.
Furthermore, there is evidence that
transport and subsequent oxidation of
volatile alcohol LCPFAC chemical
substance precursors contribute to the
levels of LCPFAC chemical substances
in the environment.
For a more detailed summary of
background information (e.g., chemistry,
environmental fate, exposure pathways,
and health and environmental effects),
as well as references pertaining to
LCPFAC chemical substances, please
refer to Unit IV. of EPA’s initial
proposed SNUR on LCPFAC chemical
substances published in the Federal
Register of August 15, 2012 (Ref. 10).
F. What are the potential health and
environmental effects of PFAS chemical
substances?
PFAS chemical substances degrade
ultimately to perfluoroalkylsulfonic acid
(PFASA), which can exist in the anionic
form under environmental conditions.
Further degradation of PFASA is not
observed under normal environmental
conditions. PFASA is highly persistent
in the environment and has a tendency
to bioaccumulate (Ref. 25). PFASA can
continue to be formed by any PFAS
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containing chemical substances
introduced into the environment.
Studies have found PFAS chemical
substances containing 5 to 14 carbons
(C5–C14) in the blood of the general
human population as well as in wildlife,
indicating that exposure to these
chemical substances is widespread
(Refs. 1, 4, 26, 27, 28, and 29). The
widespread presence of PFAS chemical
substances in human blood samples
nationwide suggests other pathways of
exposure, possibly including the release
of PFAS from treated articles.
Biological sampling has shown the
presence of certain perfluoroalkyl
compounds in fish and in fish-eating
birds across the United States and in
locations in Canada, Sweden, and the
South Pacific (Refs. 26 and 27). The
wide distribution of the chemical
substances in high trophic levels is
strongly suggestive of the potential for
bioaccumulation and/or
bioconcentration.
Based on currently available
information, EPA believes that while all
PFAS chemical substances are expected
to persist, the length of the
perfluorinated chain may also have an
effect on bioaccumulation and toxicity,
which are also characteristics of concern
for these chemical substances. PFAS
chemical substances with longer carbon
chain lengths may be of greater concern
than those with shorter chain lengths
(Refs. 4, 21, and 22).
The hazard assessment published by
the Organization for Economic
Cooperation and Development (Ref. 10)
concluded that perfluorooctyl sulfonates
(PFOS) are persistent, bioaccumulative
and toxic to mammalian species. While
most studies to date have focused
primarily on PFOS, structure-activity
relationship analysis indicates that the
results of those studies are applicable to
the entire category of PFAS chemical
substances, which includes PFOS.
Available test data have raised concerns
about their potential developmental,
reproductive, and systemic toxicity
(Refs. 1, 16, 26, and 27).
For a more detailed summary of
background information (e.g., chemistry,
environmental fate, exposure pathways,
and health and environmental effects),
as well as references pertaining to PFAS
chemical substances, please refer to
EPA’s proposed SNURs on PFAS
chemical substances published in the
Federal Register of October 18, 2000
(Ref. 30), March 11, 2002, and March 10,
2006 (Refs. 26 and 31). Also, refer to the
2009 Action Plan (Ref. 1).
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III. Rationale and Objectives
A. Rationale
EPA is concerned about the effects
LCPFAC and PFAS chemical substances
may have on human health and the
environment. As discussed in Unit II.,
LCPFAC and PFAS chemical substances
are found world-wide in the
environment, wildlife, and humans.
They are bioaccumulative in wildlife
and humans, and are persistent in the
environment. They are toxic to
laboratory animals, producing
reproductive, developmental, and
systemic effects in laboratory tests. The
exact sources and pathways by which
these chemicals move into and through
the environment and allow humans and
wildlife to become exposed are not fully
understood, but are likely to include
releases from manufacturing of the
chemicals, processing of these
chemicals into products, and aging,
wear, and disposal of products
containing them.
Since the manufacture and processing
of LCPFAC chemical substances listed
in Table 1 of Unit I. will be
discontinued after December 31, 2015,
as committed by the principal
manufacturers of LCPFAC chemical
substances participating in the PFOA
Stewardship Program, EPA expects the
presence of LCPFAC chemical
substances in humans and the
environment to decline over time as has
been observed in the past when
production and use of other persistent
chemicals has ceased (Ref. 32).
Similarly, EPA expects other LCPFAC
chemicals substances to decline as well
since the manufacture and processing of
those has ceased, as observed by the
absence of reporting in the CDR 2012
reporting period. In addition, EPA
expects the presence of PFAS chemical
substances to decline in humans and the
environment since PFAS is no longer
imported as part of carpets. EPA is
concerned that the manufacturing or
processing of these chemical substances
for the proposed significant new uses
could be reinitiated in the future. If
reinitiated, EPA believes that such use
would significantly increase the
magnitude and duration of exposure to
humans and the environment to these
chemical substances.
Accordingly, EPA wants the
opportunity to evaluate and control,
where appropriate, activities associated
with those uses, if such manufacturing
(including importing) or processing
were to start or resume. The required
notification provided by a SNUN would
provide EPA with the opportunity to
evaluate activities associated with a
significant new use and an opportunity
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to protect against unreasonable risks, if
any, from exposure to LCPFAC chemical
substances.
Consistent with EPA’s past practice
for issuing SNURs under TSCA section
5(a)(2), EPA’s decision to propose a
SNUR for a particular chemical use
need not be based on an extensive
evaluation of the hazard, exposure, or
potential risk associated with that use.
Rather, the Agency’s action is based on
EPA’s determination that if the use
begins or resumes, it may present a risk
that EPA should evaluate under TSCA
before the manufacturing or processing
for that use begins. Since the new use
does not currently exist, deferring a
detailed consideration of potential risks
or hazards related to that use is an
effective use of resources. If a person
decides to begin manufacturing or
processing the chemical for the use, the
notice to EPA allows EPA to evaluate
the use according to the specific
parameters and circumstances
surrounding that intended use.
B. Objectives
Based on the considerations in Unit
III.A., EPA wants to achieve the
following objectives with regard to the
significant new use(s) that are
designated in this proposed rule:
1. EPA would receive notice of any
person’s intent to manufacture or
process LCPFAC chemical substances,
PFOA or its salts, or PFAS chemical
substances for the described significant
new use before that activity begins.
2. EPA would have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing or processing
these chemical substances for the
described significant new use.
3. EPA would be able to regulate
prospective manufacturers or processors
of these chemical substances before the
described significant new use of the
chemical substance occurs, provided
that regulation is warranted pursuant to
TSCA sections 5(e), 5(f), 6, or 7.
IV. Significant New Use Determination
Section 5(a)(2) of TSCA states that
EPA’s determination that a use of a
chemical substance is a significant new
use must be made after consideration of
all relevant factors including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
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of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In addition to these factors
enumerated in TSCA section 5(a)(2), the
statute authorizes EPA to consider any
other relevant factors.
To determine what would constitute a
significant new use of the LCPFAC and
PFAS chemical substances subject to
this proposed rule, as discussed in this
unit. EPA considered relevant
information about the toxicity of these
substances, trends in blood levels, likely
human exposures and environmental
releases associated with possible uses,
and the four factors listed in TSCA
section 5(a)(2).
As discussed in Unit III.A., once the
manufacture (including import) and
processing of LCPFAC chemical
substances for these uses discontinue in
the United States, exposure will
decrease over time. EPA expects their
presence in humans and the
environment to concomitantly decline
over time. If any of the new use of
LCPFAC chemical substances were to
begin after phasing out, EPA believes
that such use could both change the
type and form and increase the
magnitude and duration of human and
environmental exposure to the
substances, constituting a significant
new use. Based on consideration of the
statutory factors discussed herein, EPA
has preliminary determined the
following uses as significant new uses:
• Manufacturing (including
importing) or processing of LCPFAC
chemical substances listed in Table 1 of
Unit I. for any uses that are no longer
ongoing after December 31, 2015.
• Manufacturing (including
importing) or processing of PFOA or its
salts for any use.
• Manufacturing (including
importing) or processing of all other
LCPFAC chemical substances for any
use not ongoing as of the date on which
this proposed rule is published.
EPA’s Office of Research and
Development has conducted research
demonstrating that perfluorinated
chemicals contained in articles of
commerce can be released from those
articles. For instance, one study
observed the removal of perfluorinated
chemicals from treated carpet as a result
of carpet cleaning and showed that
perfluorinated chemicals contained in
treated carpet could be released to the
environment (Ref. 33). A second study
indicated that perfluorinated chemicals
could be released from treated medical
garments with water alone (Ref. 34).
LCPFAC chemical substances may be
similarly released from related articles.
EPA believes that once manufacturing of
LCPFAC chemical substances have been
phased out, there will be fewer articles
containing the chemicals substances in
the public domain over time and thus,
exposure through articles will decrease
over time. EPA believes any new use of
LCPFAC chemical substances as part of
articles would increase the duration and
magnitude of human and environmental
exposure to the substances. Based on
these considerations, EPA has
preliminarily determined that importing
LCPFAC chemical substances listed in
Table 1 of Unit I. and PFOA or its salts
as part of articles both constitutes a
significant new use and warrants
making the exemption at 40 CFR
721.45(f) inapplicable to importers of
articles. However, import of
fluoropolymer dispersions and
emulsions, and fluoropolymers as part
of articles, containing PFOA or its salts
2891
was not determined to be a significant
new use because this use is currently
ongoing and EPA is not making
inapplicable any of the standard
exemptions at 40 CFR 721.45 for PFOA.
In a previous rule EPA designated all
uses of the PFAS chemicals identified in
40 CFR 721.9582 as significant new
uses, except the ongoing uses specified
in 40 CFR 721.9582 (a)(3) through (a)(5),
the Agency believes the manufacture
(including import) and processing of
any of the PFAS chemical substances
subject to this rule has been
discontinued, including the importing
of these chemical substances as part of
carpets. Based on EPA’s Office of
Research and Development’s research
and the considerations in the preceding
paragraphs (see, e.g., Ref. 30), EPA
believes that if the import of carpets
containing these chemical substances
were to resume, people and the
environment could be exposed to these
chemical substances in articles. The
existing regulation at 40 CFR 721.9582
broadly defined the significant use in a
way that encompassed import of these
chemical substances as part of carpets,
but for clarity EPA is proposing to
expressly list import as part of carpets
as a significant new use for the
chemicals covered by 40 CFR 721.9582,
and in light of the referenced
considerations, EPA is now proposing to
make inapplicable the exemption at 40
CFR 721.45 to importers of these
chemical substances as part of articles.
As noted in Unit V., EPA is proposing
that the exemption at 40 CFR 721.45(f)
remain in effect for persons who process
chemical substances as part of articles
because existing stocks of articles may
still contain LCPFAC or PFAS chemical
substances.
Table 3 of this unit is a summary of
the dates relevant to EPA’s preliminary
determinations.
TABLE 3—SIGNIFICANT NEW USES FOR LCPFAC CHEMICAL SUBSTANCES, PFOA AND ITS SALTS, OTHER LCPFAC
CHEMICAL SUBSTANCES, AND PFAS CHEMICAL SUBSTANCES
New use
LCPFAC in Table 1 of
Unit I.
PFOA and
its salts
Other
LCPFAC
Manufacture or processing for any use .......
After 12/31/2015 ..........
1/21/2015
1/21/2015
PFAS
In effect (see 40 CFR 721.9582).
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LCPFAC = Long-chain perfluoroalkyl carboxylate. PFAS = Perfluoroalkyl sulfonate. PFOA = Perfluorooctanoic acid.
V. Importers and Processors of These
Chemical Substances as Part of Articles
Once the determination of a
significant new use under TSCA section
5(a)(2) has been made, EPA may
separately determine whether it would
be appropriate to make the regulatory
exemption for some or all persons who
import or process a chemical substance
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as part of an article (40 CFR 721.45(f))
inapplicable to a SNUR. In this case,
EPA believes that the assumption
underpinning this exemption, that
people and the environment will
generally not be exposed to chemical
substances as part of articles, does not
hold true. See Unit IV. for a discussion
of why EPA believes this assumption is
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incorrect. Thus EPA is proposing to
make this exemption inapplicable to
importers of the PFAS chemicals
identified in 40 CFR 721.9582 as part of
carpets and importers of the chemical
substances listed in Table 1 and Table
2 of Unit I.C. as part of an article for the
corresponding significant new uses.
EPA is requesting comment on the
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potential for exposure to these chemical
substances via these articles and for
comments on the ongoing uses of these
chemical substances as part of an
article. EPA is not proposing to make
this exemption inapplicable to
processors of these chemical substances
as part of an article. EPA previously
determined in a prior rulemaking and is
not reopening its determination to make
this exemption inapplicable to
importers of the LCPFAC chemical
substances identified in 40 CFR
721.10536(b)(1) as part of carpets.
VI. Applicability of General Provisions
General provisions for SNURs appear
under 40 CFR part 721, subpart A.
These provisions describe persons
subject to the rule, recordkeeping
requirements, exemptions to reporting
requirements, and applicability of the
rule to uses occurring before the
effective date of the final rule. However,
EPA is proposing that the exemption at
40 CFR 721.45(f) not apply to persons
who import LCPFAC chemicals
substances listed in Table 1 of Unit I.,
PFOA or its salts (See Table 2 of Unit
I. for examples of PFOA salts), and
PFAS chemicals substances listed in 40
CFR 721.9582. As a result, persons
subject to the provisions of this
proposed rule would not be exempt
from significant new use reporting if
they import those LCPFAC chemical
substances or PFOA or its salts as part
of articles or if they import PFAS
chemical substances as part of carpets.
However, EPA is also proposing that the
exemption at 40 CFR 721.45(f) remain in
effect for persons who process chemical
substances as part of an article because
existing stocks of articles may still
contain LCPFAC or PFAS chemical
substances. Provisions relating to user
fees appear at 40 CFR part 700.
According to 40 CFR 721.1(c), persons
subject to SNURs must comply with the
same notice requirements and EPA
regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In
particular, these requirements include
the information submissions
requirements of TSCA section 5(b) and
5(d)(1), the exemptions authorized by
TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR
part 720. Once EPA receives a SNUN,
EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control
the activities on which it has received
the SNUN. If EPA does not take action,
EPA is required under TSCA section
5(g) to explain in the Federal Register
its reasons for not taking action.
Persons who export or intend to
export a chemical substance identified
in the proposed or final SNUR are
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subject to the export notification
provisions of TSCA section 12(b). The
regulations that interpret TSCA section
12(b) appear at 40 CFR part 707, subpart
D. In accordance with 40 CFR 707.60(b),
this proposed SNUR does not trigger
notice of export for articles. Persons
who import a chemical substance
identified in a final SNUR are subject to
the TSCA section 13 import certification
requirements, codified at 19 CFR 12.118
through 12.127; see also 19 CFR 127.28.
Such persons must certify that the
shipment of the chemical substance
complies with all applicable rules and
orders under TSCA, including any
SNUR requirements. The TSCA section
13 import certification requirement
applies to articles containing a chemical
substance or mixture if so required by
the Administrator by a specific rule
under TSCA. At this time EPA is not
proposing to require import certification
for these chemical substances as part of
articles. The EPA policy in support of
import certification appears at 40 CFR
part 707, subpart B.
VII. Applicability of Rule to Uses
Occurring Before Effective Date of the
Final Rule
As discussed in the Federal Register
of April 24, 1990 (55 FR 17376), EPA
has decided that the intent of TSCA
section 5(a)(1)(B) is best served by
designating a use as a significant new
use as of the date of publication of the
proposed rule rather than as of the
effective date of the final rule. If uses
begun after publication of the proposed
rule were considered ongoing rather
than new, it would be difficult for EPA
to establish SNUR notice requirements,
because a person could defeat the SNUR
by initiating the proposed significant
new use before the document became
final, and then argue that the use was
ongoing as of the effective date of the
final rule. Thus, persons who begin
commercial manufacture or processing
of the chemical substance(s) that would
be regulated through this proposed rule,
if finalized, would have to cease any
such activity before the effective date of
the rule if and when finalized. To
resume their activities, these persons
would have to comply with all
applicable SNUR notice requirements
and wait until the notice review period,
including all extensions, expires. Uses
arising after the publication of the
proposed rule are distinguished from
uses that exist at publication of the
proposed rule. The former would be
new uses, the latter ongoing uses, except
that uses that are ongoing as of the
publication of the proposed rule would
not be considered ongoing uses if they
have ceased by the date of issuance of
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a final rule (as EPA expects for the
LCPFAC chemical substances listed in
Table 1 of Unit I. and PFOA or its salts).
To the extent that additional ongoing
uses are found in the course of
rulemaking, EPA would exclude those
specific chemical substances for those
specific uses from the final SNUR. EPA
has promulgated provisions to allow
persons to comply with the final SNUR
before the effective date. If a person
were to meet the conditions of advance
compliance under 40 CFR 721.45(h),
that person would be considered to have
met the requirements of the final SNUR
for those activities.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5
does not usually require developing any
particular test data before submission of
a SNUN. There are two exceptions:
• Development of test data is required
where the chemical substance subject to
the SNUR is also subject to a test rule
under TSCA section 4 (see TSCA
section 5(b)(1)).
• Development of test data may be
necessary where the chemical substance
has been listed under TSCA section
5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4
test rule or a TSCA section 5(b)(4)
listing covering the chemical substance,
persons are required only to submit test
data in their possession or control and
to describe any other data known to or
reasonably ascertainable by them (15
U.S.C. 2604(d); 40 CFR 721.25; and 40
CFR 720.50). However, as a general
matter, EPA recommends that SNUN
submitters include data that would
permit a reasoned evaluation of risks
posed by the chemical substance during
its manufacture, processing, use,
distribution in commerce, or disposal.
EPA encourages persons to consult with
the Agency before submitting a SNUN.
As part of this optional pre-notice
consultation, EPA would discuss
specific data it believes may be useful
in evaluating a significant new use.
SNUNs submitted for significant new
uses without any test data may increase
the likelihood that EPA will take action
under TSCA section 5(e) to prohibit or
limit activities associated with this
chemical.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs that provide detailed
information on:
1. Human exposure and
environmental releases that may result
from the significant new uses of the
chemical substance.
2. Potential benefits of the chemical
substance.
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3. Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
IX. SNUN Submissions
EPA recommends that submitters
consult with the Agency prior to
submitting a SNUN to discuss what data
may be useful in evaluating a significant
new use. Discussions with the Agency
prior to submission can afford ample
time to conduct any tests that might be
helpful in evaluating risks posed by the
substance. According to 40 CFR
721.1(c), persons submitting a SNUN
must comply with the same notice
requirements and EPA regulatory
procedures as persons submitting a
PMN, including submission of test data
on health and environmental effects as
described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No.
7710–25, generated using e-PMN
software, and submitted to the Agency
in accordance with the procedures set
forth in 40 CFR 721.25 and 40 CFR
720.40. e-PMN software is available
electronically at https://www.epa.gov/
opptintr/newchems.
X. Economic Analysis
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
A. SNUNs
EPA has evaluated the potential costs
of establishing SNUR reporting
requirements for potential
manufacturers and processors of the
chemical substance included in this
proposed rule (Ref. 35). In the event that
a SNUN is submitted, costs are
estimated at approximately $8,589 per
SNUN submission for large business
submitters and $6,189 for small
business submitters. These estimates
include the cost to prepare and submit
the SNUN, and the payment of a user
fee. Businesses that submit a SNUN
would be subject to either a $2,500 user
fee required by 40 CFR 700.45(b)(2)(iii),
or, if they are a small business with
annual sales of less than $40 million
when combined with those of the parent
company (if any), a reduced user fee of
$100 (40 CFR 700.45(b)(1)). The costs of
submission of SNUNs will not be
incurred by any company unless a
company decides to pursue a significant
new use as defined in this proposed
SNUR.
The proposed SNUR would require
notification to EPA before the
importation of articles containing
LCPFAC chemical substances listed in
Table 1 of Unit I. or PFOA and its salts.
While not required by the proposed
SNUR, companies importing articles
containing these chemical substances
may take additional steps to determine
whether these chemical substances are
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part of the articles they are considering
to import. Companies typically have an
understanding of the contents of the
articles they import or process;
however, there may be instances when
companies decide to gather additional
information about these articles from
suppliers if not currently available. EPA
believes that the costs associated with
such information gathering activities
would be minimal for this proposed
SNUR because these chemical
substances are unlikely to be available
for use in articles after December 31,
2015. EPA’s complete economic
analysis is available in the public docket
for this proposed rule (Ref. 35).
B. Export Notification
Under TSCA section 12(b) and the
implementing regulations at 40 CFR part
707, subpart D, exporters must notify
EPA if they export or intend to export
a chemical substance or mixture for
which, among other things, a rule has
been proposed or promulgated under
TSCA section 5. For persons exporting
a chemical substance that is the subject
of a SNUR, a one-time notice must be
provided for the first export or intended
export to a particular country. The total
costs of export notification will vary by
chemical, depending on the number of
required notifications (i.e., the number
of countries to which the chemical
substance is exported). While EPA is
unable to make any estimate of the
likely number of export notifications for
the chemical substance covered in this
proposed rule SNUR, as stated in the
accompanying EA of this proposed
SNUR, the estimated cost of the export
notification requirement on a per unit
basis is $81.04.
C. Import Chemical Substances as Part
of an Article
In proposing to make inapplicable the
exemption relating to persons that
import certain chemical substances as
part of an article, this action may affect
firms that plan to import types of
articles that may contain the subject
chemical substance. Some firms have an
understanding of the contents of the
articles they import. However, EPA
acknowledges that importers of articles
may have varying levels of knowledge
about the chemical content of the
articles that they import. These parties
may need to become familiar with the
requirements of the proposed rule. And,
while not required by the SNUR, these
parties may take additional steps to
determine whether the subject chemical
substances are part of the articles that
they are considering to import. This
determination may involve activities
such as gathering information from
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suppliers along the supply chain, and/
or testing samples of the article itself.
Costs vary across the activities chosen
and the extent of familiarity a firm has
regarding the articles it imports. Cost
ranges are presented in the Agency’s
Economic Analysis for this proposed
rule (Ref. 35). Based on available
information, EPA believes that article
importers that choose to investigate
their products would incur costs at the
lower end of the ranges presented in the
Economic Analysis. For those
companies choosing to undertake
actions to assess the composition of the
articles they import, EPA expects that
importers would take actions that are
commensurate with the company’s
perceived likelihood that a chemical
substance might be a part of an article,
and the resources it has available.
Example activities and their costs are
provided in the accompanying
Economic Analysis of this proposed rule
(Ref. 32).
XI. Alternatives
Before proposing this SNUR, EPA
considered the following alternative
regulatory actions:
A. Promulgate a TSCA Section 8(a)
Reporting Rule
Under a TSCA section 8(a) rule, EPA
could, among other things, generally
require persons to report information to
the Agency when they intend to
manufacture or process a listed
chemical for a specific use or any use.
However, for LCPFAC and PFAS
chemical substances, the use of TSCA
section 8(a) rather than SNUR authority
would have several limitations. First, if
EPA were to require reporting under
TSCA section 8(a) instead of TSCA
section 5(a), EPA would not have the
opportunity to review human and
environmental hazards and exposures
associated with the proposed significant
new use and, if necessary, take
immediate follow-up regulatory action
under TSCA section 5(e) or 5(f) to
prohibit or limit the activity before it
begins. In addition, EPA may not
receive important information from
small businesses, because such firms
generally are exempt from TSCA section
8(a) reporting requirements. In view of
the level of health and environmental
concerns about LCPFAC and PFAS
chemical substances if used for the
proposed significant new use, EPA
believes that a TSCA section 8(a) rule
for this chemical substance would not
meet EPA’s regulatory objectives.
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B. Regulate LCPFAC Chemical
Substances Under TSCA Section 6
EPA may regulate under TSCA
section 6 if ‘‘the Administrator finds
that there is a reasonable basis to
conclude that the manufacture,
processing, distribution in commerce,
use or disposal of a chemical substance
or mixture . . . presents or will present
an unreasonable risk of injury to health
or the environment.’’ (TSCA section
6(a)). Given that these chemical
substances are believed to be phasing
out, EPA concluded that risk
management action under TSCA section
6 is not necessary at this time. However,
if EPA determines that there are persons
who intend to manufacture or process
these chemicals, EPA may decide to
regulate LCPFAC chemical substances
under TSCA section 6. This proposed
SNUR would allow the Agency to
address the potential risks associated
with the proposed significant new use.
XII. Request for Comment
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
A. Do you have comments or
information about ongoing uses?
EPA welcomes comments on any
aspect of this proposed SNUR. EPA
particularly requests comment on
whether any of the current uses of any
of the specific LCPFAC chemical
substances identified in Table 1 of Unit
I. will continue to be ongoing after
December 31, 2015, or whether there are
any ongoing uses of those identified in
Table 2 of Unit I. EPA also requests
comment on whether there are currently
any ongoing uses, including use as part
of articles, of any of the remaining
LCPFAC chemical substances that were
not identified in the 2012 CDR. EPA
would welcome specific documentation
of any such ongoing use.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. It is EPA’s policy
to include all comments received in the
public docket without change or further
notice to the commenter and to make
the comments available online at https://
www.regulations.gov, including any
personal information provided, unless a
comment includes information claimed
to be CBI or other information whose
disclosure is restricted by statute. Do
not submit this information to EPA
through regulations.gov or email.
Clearly mark the part or all of the
information that you claim to be CBI.
For CBI information in a disk or CD–
ROM that you mail to EPA, mark the
outside of the disk or CD–ROM as CBI
and then identify electronically within
the disk or CD–ROM the specific
information that is claimed as CBI. In
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addition to one complete version of the
comment that includes information
claimed as CBI, a copy of the comment
that does not contain the information
claimed as CBI must be submitted for
inclusion in the public docket.
Information so marked will not be
disclosed except in accordance with
procedures set forth in 40 CFR part 2,
subpart B.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
XIII. References
The following is a listing of the
documents that are specifically
referenced in this document. The docket
includes these documents and other
information considered by EPA,
including documents that are referenced
within the documents that are in the
docket, even if the referenced document
is not physically located in the docket.
For assistance in locating these other
documents, please consult the technical
person listed under FOR FURTHER
INFORMATION CONTACT.
1. EPA. Long-Chain Perfluorinated Chemicals
Action Plan. December 30, 2009.
2. EPA. 2010/2015 PFOA Stewardship
Program. 2006. https://www.epa.gov/
oppt/pfoa/pubs/stewardship/.
3. Rizzuto, Pat. DuPont Ceases PFOA
Manufacture, Is on Track to Stop All
Uses By End of 2014. Bloomberg BNA
Daily Environmental Report. December
5, 2013.
4. 3M Company. Perfluorooctane Sulfonate:
Current Summary of Human Sera, Health
and Toxicology Data. St. Paul,
Minnesota. January 21, 1999.
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5. Washington, J.W., et al. Degradability of an
Acrylate-Linked Fluorotelomer Polymer
in Soil. Environmental Science and
Technology. 43: 6617–6623. 2009.
6. EPA. PFOA Stewardship Program Baseline
Year Summary Report. 2007. https://
epa.gov/oppt/pfoa/pubs/stewardship/
sumrpt.html#background.
7. EPA. Industry Progressing in Voluntary
Effort to Reduce Toxic Chemicals.
February 10, 2012.
8. EPA. Perfluoroalkyl Sulfonates; Significant
New Use Rule. Final Rule. Federal
Register (67 FR 72854, December 9,
2002) (FRL–7279–1).
9. EPA. Perfluoroalkyl Sulfonates; Significant
New Use Rule. Final Rule. Federal
Register (72 FR 57222, October 9, 2007)
(FRL–8150–4).
10. EPA. Perfluoroalkyl Sulfonates and LongChain Perfluoroalkyl Carboxylate
Chemical Substances; Proposed
Significant New Use Rule; Proposed
Rule. Federal Register (77 FR 48924,
August 15, 2012) (FRL–9358–7).
11. Butt, C.M., et al. Levels and Trends of
Poly- and Perfluorinated Compounds in
the Arctic Environment. Science Total
Environment. 408: 2936–2965. 2010.
12. Houde M., et al. Biological Monitoring of
Polyfluoroalkyl Substances: A Review.
Environmental Science and Technology.
40: 3463–3473. 2006.
13. Calafat A.M., et al. Polyfluoroalkyl
Chemicals in the U.S. Population: Data
From the National Health and Nutrition
Examination Survey (NHANES) 2003–
2004 and Comparisons with NHANES
1999–2000. Environmental Health
Perspective. 115(11), 1596–1602. 2007.
14. Lau C., et al. Effects of Perfluoroctanoic
Acid Exposure During Pregnancy in the
Mouse. Toxicology Science. 90(2): 510–
518. 2006.
15. Lau C., et al. Perfluoroalkyl Acids: A
Review of Monitoring and Toxicological
Findings. Toxicological Sciences. 99(2):
366–394. 2007.
16. Ahrens L., et al. Polyfluoroalkyl
Compounds in the Aquatic Environment:
A Review of Their Occurrence and Fate.
Journal of Environmental Monitoring. 13:
20–31. 2011.
17. Sturm R., et al. Trends of Polyfluoroalkyl
Compounds in Marine Biota and in
Humans. Environmental Chemistry. 7:
457–484. 2010.
18. Lau, C. Perfluorinated Compounds.
Molecular, Clinical and Environmental
Toxicology Experientia Supplementum.
Volume 101, pp. 47–86. 2012.
19. Yoo, H., et al. Concentrations,
Distribution and Persistence of
Fluorotelomer Alcohols in Sludgeapplied Soils Near Decatur, Alabama,
USA. Environmental Science &
Technology. 44: 8397–8402. 2010.
20. Washington, J.W., et al. Concentrations,
Distribution and Persistence of
Perfluoroalkylates in Sludge-applied
Soils Near Decatur, Alabama, USA.
Environmental Science and Technology.
44: 8390–8396. 2010.
21. Kudo, N., et.al. Comparison of the
Elimination Between Perfluorinated
Fatty Acids with Different Carbon Chain
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Lengths in Rats. Chemico-Biological
Interactions. Volume 134(2), pp. 203–
216. 2001.
22. Goecke-Flora, C.M., et al. Influence of
Carbon Chain Length on the Hepatic
Effects of Perfluorinated Fatty Acids,
A\19\ F- and \31\P–NMR Investigation.
Chemical Research in Toxicology. 9(4),
pp. 689–695. 1996.
23. Lasier, P.J., et al. Perfluorinated
Chemicals in Surface Waters and
Sediments from Northwest Georgia,
USA, and Their Bioaccumulation in
Lumbriculus Variegates. Environmental
Toxicology andChemistry. 30: 2194–
2201. 2011.
24. 3M Company. Fluorochemical Use,
Distribution, and Release Overview. St.
Paul, Minnesota. May 26, 1999.
25. Lua, C. Perfluorinated Compounds.
Molecular, Clinical and Environmental
Toxicology Experientia Supplementum.
Volume 101, pp. 47–86. 2012.
26. EPA. Perfluoroalkyl Sulfonates; Proposed
Significant New Use Rule; Proposed
Rule. Federal Register (67 FR 11014,
March 11, 2002) (FRL–6823–7).
27. EPA. Perfluoroalkyl Sulfonates;
Significant New Use Rule; Final Rule.
Federal Register (67 FR 11008, March
11, 2002) (FRL–6823–6).
28. 3M Company. The Science of Organic
Fluorochemistry. St. Paul, Minnesota.
February 5, 1999.
29. Centers for Disease Control and
Prevention. Fourth National Report on
Human Exposure to Environmental
Chemicals. Updated Tables. March 2013.
30. EPA. Perfluoroalkyl Sulfonates;
Significant New Use Rule; Proposed
Rule. Federal Register (65 FR 62319,
October 18, 2000) (FRL–6745–5).
31. EPA. Perfluoroalkyl Sulfonates; Proposed
Significant New Use Rule; Proposed
Rule. Federal Register (71 FR 12311,
March 10, 2006) (FRL–7740–6).
32. Kato, K. et al. Trends in Exposure to
Polyfluoroalkyl Chemicals in the U.S.
Population: 1999–2008. Environmental
Science and Technology. 45: 8037–8045.
2011.
33. Hubbard, H. et al. Removal of
Perfluorocarboxylic Acids (PFCAs) from
Carpets Treated with Stain-Protection
Products by Using Carpet Cleaning
Machines. EPA, Report EPA/600–12/703.
2012.
34. Liu, X. et al. Trends of Perfluoroalkyl
Acid Content in Articles of Commerce.
EPA, Report EPA/600/R–12/585. 2012.
35. EPA. Economic Analysis of the
Significant New use Rule for Long-Chain
Perfluoroalkyl Carboxylate Chemical
Substances. August 20, 2013.
36. EPA. Modification of Significant New Use
Rules for Certain Substances; Final Rule.
Federal Register (62 FR 42690, August 8,
1997) (FRL–5735–4).
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XIV. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This proposed SNUR has been
designated by the Office of Management
and Budget (OMB) as a ‘‘significant
regulatory action’’ under section 3(f) of
Executive Order 12866 (58 FR 51735,
October 4, 1993). Accordingly, EPA
submitted this proposed action to OMB
for review under Executive Order 12866
and 13563 (76 FR 3821, January 21,
2011), and any changes made in
response to OMB recommendations are
documented in the docket.
B. Paperwork Reduction Act (PRA)
This action would not impose any
new information collection burden
under PRA, 44 U.S.C. 3501 et seq.
Burden is defined in 5 CFR 1320.3(b).
The information collection activities
associated with existing chemical
SNURs are already approved by OMB
under OMB control number 2070–0038
(EPA ICR No. 1188); and the
information collection activities
associated with export notifications are
already approved by OMB under OMB
control number 2070–0030 (EPA ICR
No. 0795). If an entity were to submit a
SNUN to the Agency, the annual burden
is estimated to be less than 100 hours
per response, and the estimated burden
for an export notifications is less than
1.5 hours per notification. In both cases,
burden is estimated to be reduced for
submitters who have already registered
to use the electronic submission system.
Additional burden, estimated to be less
than 10 hours, could be incurred where
additional recordkeeping requirements
are specified under 40 CFR 721.125(a),
(b), and (c).
An Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument, or form, if
applicable.
C. Regulatory Flexibility Act (RFA)
Pursuant to RFA section 605(b), 5
U.S.C. 601 et seq., I hereby certify that
promulgation of this proposed SNUR
would not have a significant economic
impact on a substantial number of small
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entities. The rationale supporting this
conclusion is as follows.
EPA generally finds that proposed
and final SNURs are not expected to
have a significant economic impact on
a substantial number of small entities
(See, e.g., Ref. 36). Since these proposed
SNURs would require a person who
intends to engage in such activity in the
future to first notify EPA by submitting
a SNUN, no economic impact would
occur unless someone files a SNUN to
pursue a significant new use in the
future or forgoes profits by avoiding or
delaying the significant new use.
Although some small entities may
decide to engage in such activities in the
future, EPA cannot presently determine
how many, if any, there may be.
However, EPA’s experience to date is
that, in response to the promulgation of
SNURs covering over 1,000 chemical
substances, the Agency receives only a
handful of notices per year. During the
six year period from 2005–2011, only
three submitters self-identified as small
in their SNUN submission (Ref. 35).
EPA believes the cost of submitting a
SNUN is relatively small compared to
the cost of developing and marketing a
chemical new to a firm and that the
requirement to submit a SNUN
generally does not have a significant
economic impact.
A SNUR applies to any person
(including small or large entities) who
intends to engage in any activity
described in the rule as a ‘‘significant
new use.’’ EPA has preliminarily
determined, based in part, on the
Agency’s market research, that these
chemical substances are not being
manufactured (including imported) or
processed for a significant new use. This
preliminary determination also includes
importation of these chemical
substances as part of articles for the
significant new use (Unit IV.).
In addition, given existing regulatory
limitations both internationally and
within the U.S., industry-wide
processes, resources that support
companies in understanding and
managing their supply chains, and the
evidence showing minimal worldwide
availability of the LCPFACs regulated
under the SNUR, EPA believes that
there will be minimal impact to
importers of these chemical substances
as part of articles from this proposed
SNUR. Therefore, based on current
knowledge, EPA has preliminarily
determined that these uses, including
the importation of these chemical
substances as part of articles, are not
ongoing, and that no small entities
presently manufacture for the
significant new uses addressed in this
proposed rule. EPA will consider
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information received during the
comment period that might indicate that
this preliminary determination is
incorrect. The SNUR does not require
importers of articles to conduct specific
activities to ascertain if they are
importing an article that uses a chemical
subject to the proposed rule. EPA
expects importers would take actions
that are commensurate with their
perceived likelihood of a chemical
substance subject to the SNUR being
part of an article, and the resources it
has available. EPA has no reason to
believe that a firm would voluntarily
incur substantial costs to comply with
the SNUR, but rather each firm will
choose the most efficient route to
identify whether it is importing the
subject chemical substances in articles.
Therefore, EPA believes that the
potential economic impact of complying
with this proposed SNUR is not
expected to be significant or adversely
impact a substantial number of small
entities.
D. Unfunded Mandates Reform Act
(UMRA)
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reason to
believe that any State, local, or Tribal
government would be impacted by this
proposed rulemaking. As such, the
requirements of UMRA sections 202,
203, 204, or 205, 2 U.S.C. 1531–1538, do
not apply to this proposed action.
E. Executive Order 13132: Federalism
This action would not have a
substantial direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132 (64 FR 43255,
August 10, 1999).
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This proposed rule does not have
Tribal implications because it is not
expected to have any effect (i.e., there
would be no increase or decrease in
authority or jurisdiction) on Tribal
governments, on the relationship
between the Federal Government and
the Indian Tribes, or on the distribution
of power and responsibilities between
the Federal Government and Indian
Tribes. Thus, Executive Order 13175 (65
FR 67249, November 9, 2000) does not
apply to this proposed rule.
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G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This proposed action is not subject to
Executive Order 13045 (62 FR 19885,
April 23, 1997), because this proposed
action is not intended to address
environmental health or safety risks for
children.
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
This proposed rule is not subject to
Executive Order 13211 (66 FR 28355,
May 22, 2001), because this action is not
expected to affect energy supply,
distribution, or use.
I. National Technology Transfer
Advancement Act (NTTAA)
Since this proposed action does not
involve any technical standards, section
12(d) of the NTTAA, 15 U.S.C. 272 note,
does not apply to this proposed action.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
This proposed action does not entail
special considerations of environmental
justice related issues as delineated by
Executive Order 12898 (59 FR 7629,
February 16, 1994), because EPA has
determined that this proposed action
would not have disproportionately high
and adverse human health or
environmental effects on minority or
low-income populations. This proposed
action would not affect the level of
protection provided to human health or
the environment.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: December 18, 2014.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
PART 721—[AMENDED]
1. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. In § 721.9582:
a. Redesignate paragraph (a) as (b).
b. Add new paragraph (a).
c. Revise newly designated paragraph
(b)(2)(iv).
■ d. Add paragraph (c).
The amendments read as follows:
■
■
■
■
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§ 721.9582 Certain perfluoroalkyl
sulfonates.
(a) Definitions. The definitions in
§ 721.3 apply to this section. In
addition, the following definition
applies:
Carpet means a finished fabric or
similar product intended to be used as
a floor covering. This definition
excludes resilient floor coverings such
as linoleum and vinyl tile.
(b) * * *
(2) * * *
(iv) Import as part of carpets.
*
*
*
*
*
(c) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (c).
(1) Revocation of certain notification
exemptions. With respect to imports of
carpets, the provisions of § 721.45(f) do
not apply to this section. A person who
imports a chemical substance identified
in this section as part of a carpet is not
exempt from submitting a significant
new use notice. The other provision of
§ 721.45(f), respecting processing a
chemical substance as part of an article,
remains applicable.
(2) [Reserved]
■ 3. Revise § 721.10536 to read as
follows:
§ 721.10536 Long-chain perfluoroalkyl
carboxylate chemical substances.
(a) Definitions. The definitions in
§ 721.3 apply to this section. In
addition, the following definition
applies:
Carpet means a finished fabric or
similar product intended to be used as
a floor covering. This definition
excludes resilient floor coverings such
as linoleum and vinyl tile.
(b) Chemical substances and
significant new uses subject to reporting.
(1) The chemical substances identified
below, where 5 < n < 21 or 6 < m < 21,
are subject to reporting under this
section for the significant new uses
described in paragraph (b)(4)(i) and
(b)(4)(iv) of this section.
(i) CF3(CF2)n-COO M where M = H+
or any other group where a formal
dissociation can be made.
(ii) CF3(CF2)n-CH=CH2.
(iii) CF3(CF2)n-C(=O)-X where X is any
chemical moiety.
(iv) CF3(CF2)m-CH2-X where X is any
chemical moiety.
(v) CF3(CF2)m-Y–X where Y = non-S,
non-N heteroatom and where X is any
chemical moiety.
(2) The chemical substances listed in
Table 1 of this paragraph are subject to
reporting under this section for the
significant new uses described in
paragraph (b)(4)(ii) of this section.
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2897
TABLE 1—LCPFAC CHEMICAL SUBSTANCES SUBJECT TO REPORTING AFTER DECEMBER 31, 2015
CAS registry no.
(CASRN)
Accession no.
Accession
Accession
Accession
Accession
Accession
Accession
Chemical name
507–63–1 ......................
678–39–7 ......................
865–86–1 ......................
2043–53–0 ....................
2043–54–1 ....................
17741–60–5 ..................
No
No
No
No
No
No
Number
Number
Number
Number
Number
Number
27905–45–9 ..................
30046–31–2 ..................
No Accession Number
No Accession Number
39239–77–5 ..................
No Accession Number
60699–51–6 ..................
No Accession Number
65510–55–6 ..................
No Accession Number
68187–47–3 ..................
No Accession Number
68391–08–2 ..................
70969–47–0 ..................
125476–71–3 ................
No Accession Number
No Accession Number
No Accession Number
1078712–88–5 ..............
No Accession Number
1078715–61–3 ..............
No Accession Number
CBI ................................
CBI ................................
CBI ................................
71217 ..........................
89419 ..........................
274147 ........................
Octane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-heptadecafluoro-8-iodo1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoro1-Dodecanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,12-heneicosafluoroDecane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-heptadecafluoro-10-iodoDodecane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10 ,10-heneicosafluoro-12-iodo2-Propenoic acid, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11, 12,12,12-heneicosafluorododecyl
ester
2-Propenoic acid, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl ester
Tetradecane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12-pentacosafluoro-14iodo1-Tetradecanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,14pentacosafluoro1-Hexadecanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,16nonacosafluoroHexadecane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14nonacosafluoro-16-iodo1-Propanesulfonic acid, 2-methyl-, 2-[[1-oxo-3-[(.gamma.-.omega.-perfluoro- C4–16alkyl)thio]propyl]amino] derivs., sodium salts
Alcohols, C8–14, .gamma.-.omega.-perfluoro
Thiols, C8–20, .gamma.-.omega.-perfluoro, telomers with acrylamide
Silicic acid (H4SiO4), sodium salt (1:2), reaction products with chlorotrimethylsilane and
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoro-1-decanol
Thiols, C4–20, .gamma.-.omega.-perfluoro, telomers with acrylamide and acrylic acid, sodium salts
1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-[2-[(.gamma.-.omega.perfluoro-C4–20-a lkyl)thio]acetyl] derivs., inner salts
Polyfluoroalkyl betaine
Modified fluoroalkyl urethane
Perfluorinated polyamine
CBI = Confidential Business Information. CAS or CASRN = Chemical Abstracts Service Registry Number.
(3) The chemical substances
identified as perfluorooctanoic acid
(PFOA) and its salts, including those
listed in Table 2 of this paragraph, are
subject to reporting under this section
for the significant new uses described in
paragraph (b)(4)(iii) of this section.
TABLE 2—PFOA AND EXAMPLES OF ITS SALTS
CAS registry no. (CASRN)
335–66–0 .............................
335–67–1 .............................
335–93–3 .............................
335–95–5 .............................
2395–00–8 ...........................
3825–26–1 ...........................
Chemical name
Octanoyl
Octanoic
Octanoic
Octanoic
Octanoic
Octanoic
fluoride, pentadecafluoroacid, pentadecafluoro- (PFOA)
acid, pentadecafluoro-, silver salt
acid, pentadecafluoro-, sodium salt
acid, pentadecafluoro-, potassium salt
acid, pentadecafluoro-, ammonium salt (APFO)
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
CAS or CASRN = Chemical Abstracts Service Registry Number.
(4) Significant new uses. (i) The
significant new use for chemical
substances identified in paragraph (b)(1)
of this section are: Manufacture
(including import) or processing for use
as part of carpets or to treat carpets (e.g.,
for use in the carpet aftercare market).
(ii) The significant new use for
chemical substances identified in
paragraph (b)(2) of this section are:
Manufacture (including import) or
processing for any use after December
31, 2015.
(iii) The significant new use for
chemical substances identified in
paragraph (b)(3) of this section are:
Manufacture (including import) or
processing for any use. Import of
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16:28 Jan 20, 2015
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fluoropolymer dispersions and
emulsions, and fluoropolymers as part
of articles, containing chemical
substances identified in paragraph (b)(3)
of this section shall not be considered
as a significant new use subject to
reporting.
(iv) The significant new use for
chemical substances identified in
paragraph (b)(1) of this section, except
for those chemicals identified in Table
1 of paragraph (b)(2) of this section are:
Manufacture (including import) or
processing for any use other than that
use already covered by paragraph
(b)(4)(i) of this section.
(c) Specific requirements. The
provisions of subpart A of this part
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apply to this section except as modified
by this paragraph (c).
(1) Revocation of certain notification
exemptions. With respect to imports of
carpets, the provisions of § 721.45(f) do
not apply to this section. With respect
to imports of articles, the provisions of
§ 721.45(f) also do not apply to a
chemical substance identified in
paragraphs (b)(2) or (b)(3) of this
section. A person who imports a
chemical substance identified in
paragraph (b)(1) of this section as part
of a carpet or who imports a chemical
substance identified in paragraphs (b)(2)
or (b)(3) of this section as part of an
article is not exempt from submitting a
significant new use notice. The other
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provision of § 721.45(f), respecting
processing a chemical substance as part
of an article, remains applicable.
(2) [Reserved]
[FR Doc. 2015–00636 Filed 1–20–15; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[MB Docket No. 14–253; RM–11741; DA 15–
11]
Radio Broadcasting Services;
Sagaponack, New York
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
This document requests
comments on a Petition for Rule Making
filed by Red Wolf Broadcasting
Corporation, proposing to amend the
FM Table of Allotments, Section
73.202(b) of the Commission’s Rules, by
allotting Channel 233A at Sagaponack,
New York, as a first local service. A staff
engineering analysis indicates that
Channel 233A can be allotted to
Sagaponack consistent with the
minimum distance separation
requirements of the Commission’s Rules
with a site restriction located 3.2
kilometers (2 miles) northwest of the
community. The reference coordinates
are 40–56–01 NL and 72–18–55 WL.
DATES: Comments must be filed on or
before March 2, 2015, and reply
comments on or before March 17, 2015.
ADDRESSES: Secretary, Federal
Communications Commission, 445 12th
Street SW., Washington, DC 20554. In
addition to filing comments with the
FCC, interested parties should serve the
petitioner as follows: Scott Woodworth,
Esq., Edinger Associates PLLC, 1875 I
Street NW., Suite 500, Washington, DC
20006.
FOR FURTHER INFORMATION CONTACT:
Rolanda F. Smith, Media Bureau, (202)
418–2700.
SUPPLEMENTARY INFORMATION: This is a
synopsis of the Commission’s Notice of
Proposed Rule Making, MB Docket No.
14–253, adopted January 8, 2015, and
released January 9, 2015. The full text
of this Commission decision is available
for inspection and copying during
normal business hours in the FCC’s
Reference Information Center at Portals
II, CY–A257, 445 12th Street SW.,
Washington, DC 20554. This document
may also be purchased from the
Commission’s duplicating contractors,
Best Copy and Printing, Inc., 445 12th
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
16:28 Jan 20, 2015
Jkt 235001
Street SW., Room CY–B402,
Washington, DC 20554, telephone 1–
800–378–3160 or via email
www.BCPIWEB.com. This document
does not contain proposed information
collection requirements subject to the
Paperwork Reduction Act of 1995,
Public Law 104–13. In addition,
therefore, it does not contain any
proposed information collection burden
‘‘for small business concerns with fewer
than 25 employees,’’ pursuant to the
Small Business Paperwork Relief Act of
2002, Public Law 107–198, see 44 U.S.C.
3506(c)(4).
Provisions of the Regulatory
Flexibility Act of 1980 do not apply to
this proceeding.
Members of the public should note
that from the time a Notice of Proposed
Rule Making is issued until the matter
is no longer subject to Commission
consideration or court review, all ex
parte contacts are prohibited in
Commission proceedings, such as this
one, which involve channel allotments.
See 47 CFR 1.1204(b) for rules
governing permissible ex parte contacts.
For information regarding proper
filing procedures for comments, see 47
CFR 1.415 and 1.420.
List of Subjects in 47 CFR Part 73
Radio, Radio broadcasting.
Federal Communications Commission.
Nazifa Sawez,
Assistant Chief, Audio Division, Media
Bureau.
For the reasons discussed in the
preamble, the Federal Communications
Commission proposes to amend 47 CFR
part 73 as follows:
PART 73—RADIO BROADCAST
SERVICES
1. The authority citation for part 73
continues to read as follows:
■
Authority: 47 U.S.C. 154, 303, 334, 336
and 339.
§ 73.202
[Amended]
2. Section 73.202(b), the Table of FM
Allotments under New York, is
amended by adding Sagaponack,
Channel 233A.
■
[FR Doc. 2015–00799 Filed 1–20–15; 8:45 am]
BILLING CODE 6712–01–P
PO 00000
Frm 00060
Fmt 4702
Sfmt 4702
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 140904749–4999–01]
RIN 0648–BE50
Magnuson-Stevens Fishery
Conservation and Management Act
Provisions; Fisheries of the
Northeastern United States;
Standardized Bycatch Reporting
Methodology Omnibus Amendment
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Proposed rule; request for
comments.
AGENCY:
NMFS proposes regulations to
implement the Standardized Bycatch
Reporting Methodology Omnibus
Amendment developed by the MidAtlantic and New England Fishery
Management Councils. This amendment
was developed, in part, to respond to a
remand by the U.S. District of Columbia
Court of Appeals decision in Oceana v.
Locke. The amendment also adds
various measures to improve and
expand on the Standardized Bycatch
Reporting Methodology previously in
place. The proposed measures include:
A new prioritization process for
allocation of observers if agency funding
is insufficient; bycatch reporting and
monitoring mechanisms; analytical
techniques and allocation of at-sea
fisheries observers; a performance
standard; a review and reporting
process; framework adjustment and
annual specifications provisions; and
provisions for industry-funded
observers and observer set-aside
programs. In addition to responding to
the DC Court of Appeals remand, this
action is necessary to re-establish and
improve the Standardized Bycatch
Reporting Methodology for all 13
Greater Atlantic Region Fishery
Management Plans, as required under
the Magnuson-Stevens Fishery
Conservation and Management Act,
after the previous methodology was
vacated by the 2011 Court order.
DATES: Comments must be received on
or before February 20, 2015.
ADDRESSES: You may submit comments,
identified by NOAA–NMFS–2014–0114,
by any one of the following methods:
• Electronic Submissions: Submit all
electronic public comments via the
Federal e-Rulemaking Portal. Go to
www.regulations.gov/
SUMMARY:
E:\FR\FM\21JAP1.SGM
21JAP1
]]>Agencies
[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Proposed Rules]
[Pages 2885-2898]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00636]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2013-0225; FRL-9915-63]
RIN 2070-AJ99
Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl
Sulfonate Chemical Substances; Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is
proposing to amend a significant new use rule (SNUR) for long-chain
perfluoroalkyl carboxylate (LCPFAC) chemical substances by designating
as a significant new use manufacturing (including importing) or
processing of an identified subset of LCPFAC chemical substances for
any use that will not be ongoing after December 31, 2015, and all other
LCPFAC chemicals substances for which there are currently no ongoing
uses. For this SNUR, EPA is also proposing to make inapplicable the
exemption for persons who import LCPFAC chemical substances as part of
articles. In addition, EPA is also proposing to amend a SNUR for
perfluoroalkyl sulfonate (PFAS) chemical substances that would make
inapplicable the exemption for persons who import PFAS chemical
substances as part of carpets. Persons subject to these SNURs would be
required to notify EPA at least 90 days before commencing such
manufacture or processing. The required notifications would provide EPA
with the opportunity to evaluate the intended use and, if necessary, an
opportunity to protect against potential unreasonable risks from that
activity before it occurs.
DATES: Comments must be received on or before March 23, 2015.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2013-0225, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be
[[Page 2886]]
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Nicholas Nairn-Birch, Chemical
Control Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (202) 564-3668; email
address: nairn-birch.nicholas@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(including import) or process any of the chemical substances covered by
this proposed SNUR. The North American Industrial Classification System
(NAICS) codes that are identified in this unit are not intended to be
exhaustive, but rather provides a guide to help readers determine
whether this rule applies to them. Potentially affected entities may
include:
Manufacturers (including importers) of one or more of
subject chemical substances (NAICS codes 325 and 324110); e.g.,
chemical manufacturing and petroleum refineries.
Fiber, yarn, and thread mills (NAICS code 31311).
Carpet and rug mills (NAICS code 314110).
Home furnishing merchant wholesalers (NAICS code 423220).
Carpet and upholstery cleaning services (NAICS code
561740).
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final SNUR are subject
to the TSCA section 13 (15 U.S.C. 2612) import certification
requirements and the corresponding regulations at 19 CFR 12.118 through
12.127; see also 19 CFR 127.28. Those persons must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA, including any SNUR requirements. The EPA policy
in support of import certification appears at 40 CFR part 707, subpart
B. In addition, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule on or after
February 20, 2015 are subject to the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must
comply with the export notification requirements in 40 CFR part 707,
subpart D.
To determine whether you or your business may be affected by this
action, you should carefully examine the applicability provisions in 40
CFR 721.5 and 40 CFR 721.9582. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
B. What is the agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires persons to submit a significant
new use notice (SNUN) to EPA at least 90 days before they manufacture
or process the chemical substance for that use (15 U.S.C.
2604(a)(1)(B)). As described in Unit V., the general SNUR provisions
are found at 40 CFR part 721, subpart A.
C. What action is the Agency taking?
EPA is proposing to amend a SNUR at 40 CFR 721.10536 for LCPFAC
chemical substances by designating manufacturing (including importing)
or processing of LCPFAC chemical substances listed in Table 1 of this
unit for any use that is no longer ongoing after December 31, 2015, as
a significant new use; designating manufacturing (including importing)
or processing of PFOA or its salts for any use as a significant new
use; and designating manufacturing (including importing) or processing
of all other LCPFAC chemical substances for any use not ongoing as of
the date on which this proposed rule is published as a significant new
use. For this SNUR, EPA is also proposing to make the exemption at 40
CFR 721.45(f) inapplicable for persons who import LCPFAC chemical
substances listed in Table 1 of this unit and PFOA or its salts as part
of articles because exposure would increase if in the future LCPFAC
chemical substances, including PFOA, are incorporated in articles and
then imported. EPA is also proposing to amend a SNUR at 40 CFR 721.9582
for PFAS chemical substances to make the exemption at 40 CFR 721.45(f)
inapplicable for persons who import of PFAS chemical substances as part
of carpets. This action is consistent with the purpose of the ``Long-
Chain Perfluorinated Chemicals Action Plan'' (2009 Action Plan)
published on December 30, 2009 (Ref. 1). EPA is continuing to assess
these chemical substances to determine what other actions would be
warranted. Before promulgating a final SNUR with respect to uses of
LCPFAC chemical substances listed in Table 1 of this unit that are now
ongoing, but are expected to be phased out by December 31, 2015, EPA
will verify through comments on this action, or by other means, that
the proposed significant new uses have indeed ceased. Similarly, before
promulgating a final SNUR on LCPFAC chemical substances other than
those listed in Table 1 of this unit, EPA will determine based on
comments on this action and other means what if any uses are ongoing in
making significant new use determinations in the final rule. Persons
would be required to notify EPA at least 90 days before commencing
manufacture or processing of LCPFAC chemical substances for the
designated significant new uses. This proposed SNUR is intended to
follow and codify an existing voluntary industry commitment to phase
out LCPFAC chemical substances by the end of 2015 (Ref. 2). The
objectives and rationale for this proposed SNUR are explained in more
detail in Unit III.
[[Page 2887]]
Table 1--LCPFAC Chemical Substances Subject to Reporting After December 31, 2015
----------------------------------------------------------------------------------------------------------------
CAS registry No. (CASRN) Accession CAS No. Chemical name
----------------------------------------------------------------------------------------------------------------
507-63-1............................. No Accession Number.... Octane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-
heptadecafluoro-8-iodo-.
678-39-7............................. No Accession Number.... 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
heptadecafluoro-.
865-86-1............................. No Accession Number.... 1-Dodecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,1
2-heneicosafluoro-.
2043-53-0............................ No Accession Number.... Decane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-
heptadecafluoro-10-iodo-.
2043-54-1............................ No Accession Number.... Dodecane,
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10-
heneicosafluoro-12-iodo-.
17741-60-5........................... No Accession Number.... 2-Propenoic acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,
12,12,12-heneicosafluorododecyl ester.
27905-45-9........................... No Accession Number.... 2-Propenoic acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
heptadecafluorodecyl ester.
30046-31-2........................... No Accession Number.... Tetradecane,
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,
11,12,12-pentacosafluoro-14-iodo-.
39239-77-5........................... No Accession Number.... 1-Tetradecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,1
3,13,14,14,14-pentacosafluoro-.
60699-51-6........................... No Accession Number.... 1-Hexadecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,1
3,13,14,14,15,15,16,16,16-nonacosafluoro-.
65510-55-6........................... No Accession Number.... Hexadecane,
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,
11,12,12,13,13,14,14-nonacosafluoro-16-iodo-.
68187-47-3........................... No Accession Number.... 1-Propanesulfonic acid, 2-methyl-, 2-[[1-oxo-3-
[(.gamma.-.omega.-perfluoro- C4-16-
alkyl)thio]propyl]amino] derivs., sodium salts.
68391-08-2........................... No Accession Number.... Alcohols, C8-14, .gamma.-.omega.-perfluoro.
70969-47-0........................... No Accession Number.... Thiols, C8-20, .gamma.-.omega.-perfluoro,
telomers with acrylamide.
125476-71-3.......................... No Accession Number.... Silicic acid (H4SiO4), sodium salt (1:2),
reaction products with chlorotrimethylsilane
and 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
heptadecafluoro-1-decanol.
1078712-88-5......................... No Accession Number.... Thiols, C4-20, .gamma.-.omega.-perfluoro,
telomers with acrylamide and acrylic acid,
sodium salts.
1078715-61-3......................... No Accession Number.... 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-
dimethyl-, N-[2-[(.gamma.-.omega.-perfluoro-C4-
20-a lkyl)thio]acetyl] derivs., inner salts.
CBI.................................. 71217.................. Polyfluoroalkyl betaine.
CBI.................................. 89419.................. Modified fluoroalkyl urethane.
CBI.................................. 274147................. Perfluorinated polyamine.
----------------------------------------------------------------------------------------------------------------
CBI = Confidential Business Information. CAS or CASRN = Chemical Abstracts Service Registry Number.
In this proposed rule, the term LCPFAC refers to the long-chain
category of perfluorinated carboxylate chemical substances with
perfluorinated carbon chain lengths equal to or greater than seven
carbons and less than or equal to 20 carbons. The category of LCPFAC
chemical substances also includes the salts and precursors of these
perfluorinated carboxylates. See Unit II.A. for the specific definition
of the LCPFAC category.
PFOA and its salts are subject to this proposed rule. PFOA and
examples of PFOA salts with Chemical Abstract Service Registry Numbers
(CASRN) and chemical names are shown in Table 2 of this unit. PFOA and
its salts are considered LCPFAC chemical substances. EPA believes all
uses of PFOA and its salts were phased out by December 31, 2013.
Table 2--PFOA and Examples of Its Salts
------------------------------------------------------------------------
CAS registry No. (CASRN) Chemical name
------------------------------------------------------------------------
335-66-0............................ Octanoyl fluoride, pentadecafluoro-
.
335-67-1............................ Octanoic acid, pentadecafluoro-
(PFOA).
335-93-3............................ Octanoic acid, pentadecafluoro-,
silver salt.
335-95-5............................ Octanoic acid, pentadecafluoro-,
sodium salt.
2395-00-8........................... Octanoic acid, pentadecafluoro-,
potassium salt.
3825-26-1........................... Octanoic acid, pentadecafluoro-,
ammonium salt (APFO).
------------------------------------------------------------------------
CAS or CASRN = Chemical Abstracts Service Registry Number.
The PFAS chemical substances for which EPA is modifying an existing
SNUR are currently listed in 40 CFR 721.9582(a)(1). All of these
chemical substances are collectively referred to in this rule as
perfluoroalkyl sulfonates, or PFAS chemical substances. In this
proposal, the term PFAS refers to a category of perfluorinated
sulfonate chemical substances of any chain length.
EPA will not designate ongoing uses as significant new uses when
the final rule is promulgated, except for uses that will be phased out
by the end of 2015. Persons who manufacture (including importers) or
process any of the chemical substances included in the proposed SNUR
for an ongoing use at the time this proposed rule is published would be
free to continue without submitting a SNUN. Note, however, that uses
not already ongoing as of the publication date of this proposed rule,
and ongoing uses that will be phased out by the end of 2015, would not
be considered ongoing uses if they later arise, even if they are in
existence upon the issuance of a final rule. Furthermore, uses that are
ongoing as of the publication date of this proposed rule would not be
considered ongoing uses if they have ceased by the date of issuance of
a final rule (see Units IV. and VI. for further discussion of what
constitutes an ongoing use). Persons who intend to begin or resume
commercial manufacture or processing of the chemical substance(s) for a
significant new use would have to comply with all applicable SNUN
requirements.
The LCPFAC chemical substances identified in Table 1 of this unit
are known to have current or recent ongoing uses on the basis of their
inclusion in reports submitted to the Agency under the 2012 Chemical
Data Reporting (CDR) rule. EPA particularly requests comment on whether
any of the current uses of any of the specific chemical substances
identified in Table 1 of this unit will continue to be ongoing after
December 31, 2015. EPA also requests comment on whether there are
currently any ongoing uses, including use as part of articles, of any
of the remaining LCPFAC chemical substances that were not identified
during the 2012 CDR. Furthermore, EPA requests comment on whether there
are any ongoing uses of PFOA or its salts, and whether PFAS chemical
substances
[[Page 2888]]
are currently imported as part of carpets. EPA would welcome specific
documentation of any such ongoing use.
D. Why is the Agency taking this action?
These SNURs are necessary to ensure that EPA receives timely
advance notice of any future manufacturing (including importing) and
processing of these LCPFAC chemical substances for new uses that may
produce changes in human and environmental exposures. The rationale and
objectives for this SNUR are explained in Unit III.
E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substances included in this
proposed rule. The economic analysis, which is available in the docket,
is discussed in Unit IX., and is briefly summarized here.
In the event that a SNUN is submitted, costs are estimated to be
less than $8,589 per SNUN submission for large business submitters and
$6,189 for small business submitters. These estimates include the cost
to prepare and submit the SNUN and the payment of a user fee. In
addition, for persons exporting a chemical substance that is the
subject of a SNUR, a one-time notice must be provided for the first
export or intended export to a particular country, which is estimated
to cost less than $100 on average per notification. The proposed rule
may also affect firms that plan to import articles that contain LCFPAC
chemical substances, because, while not required by the SNUR, these
parties may take additional steps to determine whether LCPFAC chemical
substances are part of the articles that they are considering to
import. In the accompanying Economic Analysis for this proposed SNUR,
example steps (and their respective costs) that an importer might take
to identify LCPFAC chemicals in articles are provided. These can
include gathering information through agreements with suppliers,
declarations through databases or surveys, or use of a third party
certification system. Additionally, importers may require suppliers to
provide certificates of testing analysis of the products or perform
their own laboratory testing of certain articles. EPA is unable to
predict, however, what, if any, particular steps an importer might
take; potential total costs were not estimated.
II. Chemical Substances Subject to This Proposed Rule
A. What LCPFAC chemical substances are subject to this proposed SNUR?
LCPFAC chemical substances are synthetic chemicals that do not
occur naturally in the environment. The LCPFAC chemical substances
identified in this unit, where 5 < n < 21 or 6 < m < 21:
1. CF3(CF2)n-COO-M
where M = H+ or any other group where a formal dissociation
can be made.;
2. CF3(CF2)n-CH=CH2.
3. CF3(CF2)n-C(=O)-X where X is
any chemical moiety.
4. CF3(CF2)m-CH2-X
where X is any chemical moiety.
5. CF3(CF2)m-Y-X where Y = non-S,
non-N heteroatom and where X is any chemical moiety.
This category definition of LCPFAC chemical substances, based on
the chemical structures in this unit, refers to a group of chemical
substances containing PFOA and its higher homologues. The category also
includes the salts and precursors of these chemical substances. The
precursors may be simple derivatives of PFOA and higher homologues or
polymers that contain or may degrade to PFOA or higher homologues.
These precursors include long-chain fluorotelomers. LCPFAC chemical
substances with greater than 20 perfluorinated carbons can be
considered polymers within the polymer exemption under 40 CFR 723.250
because they exceed a molecular weight of 1,000 daltons and contain at
least 3 monomer units. As it is not EPA's intent to regulate
fluoropolymers in this proposed rule, the LCPFAC category in this
proposed rule includes a perfluorinated carbon chain length upper limit
of 20.
In this proposed rule, PFOA and its salts includes the chemical
substances listed in Table 2 of Unit II. PFOA and its salts are
considered LCPFAC chemical substances.
Under this proposed rule, any LCPFAC chemical substance identified
by 40 CFR 721.10536(b)(1)(i) through (b)(1)(v) that is intentionally
used during fluoropolymer formulation, such as an emulsion stabilizer
in aqueous dispersions, would be subject to reporting for the
significant new uses described in 40 CFR 721.10536(b)(4)(i) through
(b)(4)(iv). For example, ammonium perfluorooctanoate (APFO)--when used
as an aqueous dispersion agent in fluoropolymer production--is subject
to this SNUR if the final fluoropolymer product is used for a
significant new use described in 40 CFR 721.10536(b)(4)(i) through
(b)(4)(iv).
B. What PFAS chemical substances are subject to this proposed SNUR?
PFAS refers to a category of perfluorinated sulfonate chemical
substances of any chain length. The PFAS chemical substances for which
EPA is proposing to modify an existing SNUR are currently listed in 40
CFR 721.9582(a)(1).
C. What are the uses and production levels of LCPFAC chemical
substances?
PFOA, a member of the LCPFAC category, is a synthetic (man-made)
chemical that does not occur naturally in the environment. PFOA is
manufactured for use primarily as an aqueous dispersion agent as the
ammonium salt in the manufacture of fluoropolymers. PFOA can also be
produced unintentionally by the degradation of some fluorotelomers,
which are not manufactured using PFOA but could degrade to PFOA.
DuPont, which was the last company to manufacture (including import)
PFOA and its salts in the United States, ceased all production
(including import) of PFOA and its salts in 2013 (Ref. 3).
Fluoropolymers provide nonstick surfaces for cookware and other
products, are used as molded automotive parts, and have many other
applications. Polytetrafluoroethylene (PTFE) is the dominant
fluoropolymer, accounting for 58% (by weight) of world fluoropolymer
consumption in 2012 (Ref. 4). The United States accounted for 20% of
the world consumption of PTFE in 2012 and 40% of the world consumption
of other fluoropolymers.
Fluorotelomers, oligomers of tetrafluoroethylene, are relatively
small functionalized molecules used to make polymers and surfactants.
World-wide production of fluorotelomer-based polymers (FTBP) was
estimated at 20 million pounds in 2006. Fluorotelomer monomers and FTBP
are included in the LCPFAC category definition as potential LCPFAC
precursors (Ref. 5). The United States accounts for more than 50% of
world-wide fluorotelomer/FTPB production. Textiles and apparel account
for approximately 50% of the volume used (Ref. 1).
In January 2006, EPA launched the 2010/2015 PFOA Stewardship
Program (PFOA Stewardship Program) in partnership with eight companies:
DuPont, Solvay Solexis, Asahi Glass Company, Daikin America, Inc.,
Clariant International Ltd., 3M/Dyneon, Arkema Inc., and BASF (formerly
Ciba Specialty Chemicals Corporation) (Ref. 2). These companies
represent a majority of global
[[Page 2889]]
manufacture of LCPFAC chemical substances (Ref. 6). The program set a
goal of reducing facility emissions and product content of LCPFAC
chemical substances on a global basis by 95%, no later than 2010, and
to eliminate emissions and product content of these chemical substances
by 2015. With the exception of one manufacturer who has not
participated in the PFOA Stewardship Program, these companies accounted
for the total volume of LCPFAC chemical substances reported on the 2012
CDR (see Table 2 of Unit I.). Since these chemical substances are
proprietary chemicals, they are not expected to be manufactured by any
other company. The eight participating companies have informed EPA that
they are on track to phase out LCPFAC chemical substances by the end of
2015 (Ref. 7).
Based on the 2012 CDR, there was one additional manufacturer of
certain LCPFAC chemical substances who has not participated in the PFOA
Stewardship Program. This company manufactures a small volume of LCPFAC
chemical substances, compared to the volume of LCPFAC chemical
substances manufactured by PFOA Stewardship Program companies, and
those chemicals are primarily used in firefighting foams. This company
has expressed an interest in participating in the phase out goal of the
PFOA Stewardship Program and has already submitted premanufacture
notices (PMNs) for chemical substitutes of their current LCPFAC
chemical substances. Other than the PFOA Stewardship Program companies
and this one company, there were no other companies that reported
manufacture (including import) of LCPFAC chemical substances in the
2012 CDR. Any domestic companies still manufacturing LCPFAC chemical
substances are most likely obtaining the feedstocks for that
manufacturing process from companies participating in the PFOA
Stewardship Program. For these companies to continue manufacturing
LCPFAC chemical substances, they would need the feedstock and finished
LCPFAC chemical substances currently supplied by companies
participating in the PFOA Stewardship Program. As the PFOA Stewardship
Program member companies phase out their manufacture of those
substances and customer demand continues to shift from LCPFAC chemical
substances to alternatives, EPA believes that the manufacture of LCPFAC
chemical substances by companies not participating in the PFOA
Stewardship Programs are likely to cease by December 31, 2015. EPA
would like to receive comments addressing the extent to which companies
manufacturing specific LCPFAC chemical substances for particular uses
are utilizing existing sources that are not dependent on the PFOA
Stewardship Program member companies and that are expected to continue
after December 31, 2015. Because specific uses of those specific
chemical substances would be considered ongoing, they would be outside
the scope of the significant new use when finalized.
D. What are the uses and production levels of PFAS chemical substances?
The Agency previously determined that the 271 PFAS chemical
substances identified in 40 CFR 721.9582(a)(1) were no longer being
manufactured for any use in the United States, other than for the uses
listed under 40 CFR 721.9582(a)(3), (a)(4), and (a)(5) (Refs. 8 and 9).
PFAS chemical substances included in 40 CFR 721.9582 were previously
used in a variety of products, which can be divided into three main use
categories: Surface treatments, paper protection, and performance
chemicals. In the past, PFAS chemical substances in the performance
chemicals category were used in a wide variety of specialized
industrial, commercial, and consumer applications. Specific
applications included firefighting foams, mining and oil well
surfactants, acid mist suppressants for metal plating and electronic
etching baths, alkaline cleaners, floor polishes, inks, photographic
film, denture cleaners, shampoos, chemical intermediates, coating
additives, carpet spot cleaners, and as an insecticide in bait stations
for ants (Ref. 10). In some instances, PFAS chemical substances are no
longer used for the uses listed in 40 CFR 721.9582(a)(3), (a)(4), and
(a)(5) as a result of new substitutes developed and production and
processing changes implemented by companies to eliminate the need for
use of PFAS chemical substances. In addition, since those chemicals are
no longer manufactured (including imported) other than for the listed
uses, EPA believes that those chemical substances are also no longer
processed other than for those listed uses.
E. What are the potential health and environmental effects of LCPFAC
chemical substances?
The following brief summary of chemistry, environmental fate,
exposure pathways, and health and environmental effects of LCPFAC
chemical substances is based on the 2009 Action Plan (Ref. 1),
references cited in the 2009 Action Plan, and additional selected
references published after the 2009 Action Plan.
PFOA is persistent, widely present in humans and the environment,
has long half-lives in humans, and can cause adverse effects in
laboratory animals, including cancer and developmental and systemic
toxicity (Refs. 11, 12, 13, 14, and 15). PFOA precursors, chemicals
which degrade or may degrade to PFOA, are also present worldwide in
humans and the environment and, in some cases, might be present at
higher concentrations than PFOA and be more toxic (Refs. 16, 17, 18,
19, and 20). PFOA higher homologues are chemicals with carbon chain
lengths longer than PFOA. Available evidence suggests that toxicity and
bioaccumulation appear to be higher for chemical substances with longer
carbon chain lengths compared to those with shorter chain lengths
(Refs. 21, 22, 23, and 24).
LCPFAC chemical substances have been detected in biota, air, water,
dust, and soil samples collected throughout the world. Some LCPFAC
chemical substances have the potential for long-range transport. They
are transported over long distances by a combination of dissolved-phase
ocean and gas-phase atmospheric transport; however, determining which
is the predominant transport pathway is complicated by many factors,
including the uncertainty over water to atmosphere partitioning.
Furthermore, there is evidence that transport and subsequent oxidation
of volatile alcohol LCPFAC chemical substance precursors contribute to
the levels of LCPFAC chemical substances in the environment.
For a more detailed summary of background information (e.g.,
chemistry, environmental fate, exposure pathways, and health and
environmental effects), as well as references pertaining to LCPFAC
chemical substances, please refer to Unit IV. of EPA's initial proposed
SNUR on LCPFAC chemical substances published in the Federal Register of
August 15, 2012 (Ref. 10).
F. What are the potential health and environmental effects of PFAS
chemical substances?
PFAS chemical substances degrade ultimately to
perfluoroalkylsulfonic acid (PFASA), which can exist in the anionic
form under environmental conditions. Further degradation of PFASA is
not observed under normal environmental conditions. PFASA is highly
persistent in the environment and has a tendency to bioaccumulate (Ref.
25). PFASA can continue to be formed by any PFAS
[[Page 2890]]
containing chemical substances introduced into the environment.
Studies have found PFAS chemical substances containing 5 to 14
carbons (C5-C14) in the blood of the general human population as well
as in wildlife, indicating that exposure to these chemical substances
is widespread (Refs. 1, 4, 26, 27, 28, and 29). The widespread presence
of PFAS chemical substances in human blood samples nationwide suggests
other pathways of exposure, possibly including the release of PFAS from
treated articles.
Biological sampling has shown the presence of certain
perfluoroalkyl compounds in fish and in fish-eating birds across the
United States and in locations in Canada, Sweden, and the South Pacific
(Refs. 26 and 27). The wide distribution of the chemical substances in
high trophic levels is strongly suggestive of the potential for
bioaccumulation and/or bioconcentration.
Based on currently available information, EPA believes that while
all PFAS chemical substances are expected to persist, the length of the
perfluorinated chain may also have an effect on bioaccumulation and
toxicity, which are also characteristics of concern for these chemical
substances. PFAS chemical substances with longer carbon chain lengths
may be of greater concern than those with shorter chain lengths (Refs.
4, 21, and 22).
The hazard assessment published by the Organization for Economic
Cooperation and Development (Ref. 10) concluded that perfluorooctyl
sulfonates (PFOS) are persistent, bioaccumulative and toxic to
mammalian species. While most studies to date have focused primarily on
PFOS, structure-activity relationship analysis indicates that the
results of those studies are applicable to the entire category of PFAS
chemical substances, which includes PFOS. Available test data have
raised concerns about their potential developmental, reproductive, and
systemic toxicity (Refs. 1, 16, 26, and 27).
For a more detailed summary of background information (e.g.,
chemistry, environmental fate, exposure pathways, and health and
environmental effects), as well as references pertaining to PFAS
chemical substances, please refer to EPA's proposed SNURs on PFAS
chemical substances published in the Federal Register of October 18,
2000 (Ref. 30), March 11, 2002, and March 10, 2006 (Refs. 26 and 31).
Also, refer to the 2009 Action Plan (Ref. 1).
III. Rationale and Objectives
A. Rationale
EPA is concerned about the effects LCPFAC and PFAS chemical
substances may have on human health and the environment. As discussed
in Unit II., LCPFAC and PFAS chemical substances are found world-wide
in the environment, wildlife, and humans. They are bioaccumulative in
wildlife and humans, and are persistent in the environment. They are
toxic to laboratory animals, producing reproductive, developmental, and
systemic effects in laboratory tests. The exact sources and pathways by
which these chemicals move into and through the environment and allow
humans and wildlife to become exposed are not fully understood, but are
likely to include releases from manufacturing of the chemicals,
processing of these chemicals into products, and aging, wear, and
disposal of products containing them.
Since the manufacture and processing of LCPFAC chemical substances
listed in Table 1 of Unit I. will be discontinued after December 31,
2015, as committed by the principal manufacturers of LCPFAC chemical
substances participating in the PFOA Stewardship Program, EPA expects
the presence of LCPFAC chemical substances in humans and the
environment to decline over time as has been observed in the past when
production and use of other persistent chemicals has ceased (Ref. 32).
Similarly, EPA expects other LCPFAC chemicals substances to decline as
well since the manufacture and processing of those has ceased, as
observed by the absence of reporting in the CDR 2012 reporting period.
In addition, EPA expects the presence of PFAS chemical substances to
decline in humans and the environment since PFAS is no longer imported
as part of carpets. EPA is concerned that the manufacturing or
processing of these chemical substances for the proposed significant
new uses could be reinitiated in the future. If reinitiated, EPA
believes that such use would significantly increase the magnitude and
duration of exposure to humans and the environment to these chemical
substances.
Accordingly, EPA wants the opportunity to evaluate and control,
where appropriate, activities associated with those uses, if such
manufacturing (including importing) or processing were to start or
resume. The required notification provided by a SNUN would provide EPA
with the opportunity to evaluate activities associated with a
significant new use and an opportunity to protect against unreasonable
risks, if any, from exposure to LCPFAC chemical substances.
Consistent with EPA's past practice for issuing SNURs under TSCA
section 5(a)(2), EPA's decision to propose a SNUR for a particular
chemical use need not be based on an extensive evaluation of the
hazard, exposure, or potential risk associated with that use. Rather,
the Agency's action is based on EPA's determination that if the use
begins or resumes, it may present a risk that EPA should evaluate under
TSCA before the manufacturing or processing for that use begins. Since
the new use does not currently exist, deferring a detailed
consideration of potential risks or hazards related to that use is an
effective use of resources. If a person decides to begin manufacturing
or processing the chemical for the use, the notice to EPA allows EPA to
evaluate the use according to the specific parameters and circumstances
surrounding that intended use.
B. Objectives
Based on the considerations in Unit III.A., EPA wants to achieve
the following objectives with regard to the significant new use(s) that
are designated in this proposed rule:
1. EPA would receive notice of any person's intent to manufacture
or process LCPFAC chemical substances, PFOA or its salts, or PFAS
chemical substances for the described significant new use before that
activity begins.
2. EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing these chemical substances for the described significant new
use.
3. EPA would be able to regulate prospective manufacturers or
processors of these chemical substances before the described
significant new use of the chemical substance occurs, provided that
regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
IV. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure
[[Page 2891]]
of human beings or the environment to a chemical substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute a significant new use of the
LCPFAC and PFAS chemical substances subject to this proposed rule, as
discussed in this unit. EPA considered relevant information about the
toxicity of these substances, trends in blood levels, likely human
exposures and environmental releases associated with possible uses, and
the four factors listed in TSCA section 5(a)(2).
As discussed in Unit III.A., once the manufacture (including
import) and processing of LCPFAC chemical substances for these uses
discontinue in the United States, exposure will decrease over time. EPA
expects their presence in humans and the environment to concomitantly
decline over time. If any of the new use of LCPFAC chemical substances
were to begin after phasing out, EPA believes that such use could both
change the type and form and increase the magnitude and duration of
human and environmental exposure to the substances, constituting a
significant new use. Based on consideration of the statutory factors
discussed herein, EPA has preliminary determined the following uses as
significant new uses:
Manufacturing (including importing) or processing of
LCPFAC chemical substances listed in Table 1 of Unit I. for any uses
that are no longer ongoing after December 31, 2015.
Manufacturing (including importing) or processing of PFOA
or its salts for any use.
Manufacturing (including importing) or processing of all
other LCPFAC chemical substances for any use not ongoing as of the date
on which this proposed rule is published.
EPA's Office of Research and Development has conducted research
demonstrating that perfluorinated chemicals contained in articles of
commerce can be released from those articles. For instance, one study
observed the removal of perfluorinated chemicals from treated carpet as
a result of carpet cleaning and showed that perfluorinated chemicals
contained in treated carpet could be released to the environment (Ref.
33). A second study indicated that perfluorinated chemicals could be
released from treated medical garments with water alone (Ref. 34).
LCPFAC chemical substances may be similarly released from related
articles. EPA believes that once manufacturing of LCPFAC chemical
substances have been phased out, there will be fewer articles
containing the chemicals substances in the public domain over time and
thus, exposure through articles will decrease over time. EPA believes
any new use of LCPFAC chemical substances as part of articles would
increase the duration and magnitude of human and environmental exposure
to the substances. Based on these considerations, EPA has preliminarily
determined that importing LCPFAC chemical substances listed in Table 1
of Unit I. and PFOA or its salts as part of articles both constitutes a
significant new use and warrants making the exemption at 40 CFR
721.45(f) inapplicable to importers of articles. However, import of
fluoropolymer dispersions and emulsions, and fluoropolymers as part of
articles, containing PFOA or its salts was not determined to be a
significant new use because this use is currently ongoing and EPA is
not making inapplicable any of the standard exemptions at 40 CFR 721.45
for PFOA.
In a previous rule EPA designated all uses of the PFAS chemicals
identified in 40 CFR 721.9582 as significant new uses, except the
ongoing uses specified in 40 CFR 721.9582 (a)(3) through (a)(5), the
Agency believes the manufacture (including import) and processing of
any of the PFAS chemical substances subject to this rule has been
discontinued, including the importing of these chemical substances as
part of carpets. Based on EPA's Office of Research and Development's
research and the considerations in the preceding paragraphs (see, e.g.,
Ref. 30), EPA believes that if the import of carpets containing these
chemical substances were to resume, people and the environment could be
exposed to these chemical substances in articles. The existing
regulation at 40 CFR 721.9582 broadly defined the significant use in a
way that encompassed import of these chemical substances as part of
carpets, but for clarity EPA is proposing to expressly list import as
part of carpets as a significant new use for the chemicals covered by
40 CFR 721.9582, and in light of the referenced considerations, EPA is
now proposing to make inapplicable the exemption at 40 CFR 721.45 to
importers of these chemical substances as part of articles.
As noted in Unit V., EPA is proposing that the exemption at 40 CFR
721.45(f) remain in effect for persons who process chemical substances
as part of articles because existing stocks of articles may still
contain LCPFAC or PFAS chemical substances.
Table 3 of this unit is a summary of the dates relevant to EPA's
preliminary determinations.
Table 3--Significant New Uses for LCPFAC Chemical Substances, PFOA and Its Salts, Other LCPFAC Chemical
Substances, and PFAS Chemical Substances
----------------------------------------------------------------------------------------------------------------
LCPFAC in Table 1 of PFOA and its
New use Unit I. salts Other LCPFAC PFAS
----------------------------------------------------------------------------------------------------------------
Manufacture or processing for any After 12/31/2015...... 1/21/2015 1/21/2015 In effect (see 40 CFR
use. 721.9582).
----------------------------------------------------------------------------------------------------------------
LCPFAC = Long-chain perfluoroalkyl carboxylate. PFAS = Perfluoroalkyl sulfonate. PFOA = Perfluorooctanoic acid.
V. Importers and Processors of These Chemical Substances as Part of
Articles
Once the determination of a significant new use under TSCA section
5(a)(2) has been made, EPA may separately determine whether it would be
appropriate to make the regulatory exemption for some or all persons
who import or process a chemical substance as part of an article (40
CFR 721.45(f)) inapplicable to a SNUR. In this case, EPA believes that
the assumption underpinning this exemption, that people and the
environment will generally not be exposed to chemical substances as
part of articles, does not hold true. See Unit IV. for a discussion of
why EPA believes this assumption is incorrect. Thus EPA is proposing to
make this exemption inapplicable to importers of the PFAS chemicals
identified in 40 CFR 721.9582 as part of carpets and importers of the
chemical substances listed in Table 1 and Table 2 of Unit I.C. as part
of an article for the corresponding significant new uses. EPA is
requesting comment on the
[[Page 2892]]
potential for exposure to these chemical substances via these articles
and for comments on the ongoing uses of these chemical substances as
part of an article. EPA is not proposing to make this exemption
inapplicable to processors of these chemical substances as part of an
article. EPA previously determined in a prior rulemaking and is not
reopening its determination to make this exemption inapplicable to
importers of the LCPFAC chemical substances identified in 40 CFR
721.10536(b)(1) as part of carpets.
VI. Applicability of General Provisions
General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule. However, EPA is proposing that the exemption at 40 CFR 721.45(f)
not apply to persons who import LCPFAC chemicals substances listed in
Table 1 of Unit I., PFOA or its salts (See Table 2 of Unit I. for
examples of PFOA salts), and PFAS chemicals substances listed in 40 CFR
721.9582. As a result, persons subject to the provisions of this
proposed rule would not be exempt from significant new use reporting if
they import those LCPFAC chemical substances or PFOA or its salts as
part of articles or if they import PFAS chemical substances as part of
carpets. However, EPA is also proposing that the exemption at 40 CFR
721.45(f) remain in effect for persons who process chemical substances
as part of an article because existing stocks of articles may still
contain LCPFAC or PFAS chemical substances. Provisions relating to user
fees appear at 40 CFR part 700. According to 40 CFR 721.1(c), persons
subject to SNURs must comply with the same notice requirements and EPA
regulatory procedures as submitters of PMNs under TSCA section
5(a)(1)(A). In particular, these requirements include the information
submissions requirements of TSCA section 5(b) and 5(d)(1), the
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6,
or 7 to control the activities on which it has received the SNUN. If
EPA does not take action, EPA is required under TSCA section 5(g) to
explain in the Federal Register its reasons for not taking action.
Persons who export or intend to export a chemical substance
identified in the proposed or final SNUR are subject to the export
notification provisions of TSCA section 12(b). The regulations that
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. In
accordance with 40 CFR 707.60(b), this proposed SNUR does not trigger
notice of export for articles. Persons who import a chemical substance
identified in a final SNUR are subject to the TSCA section 13 import
certification requirements, codified at 19 CFR 12.118 through 12.127;
see also 19 CFR 127.28. Such persons must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA, including any SNUR requirements. The TSCA section 13 import
certification requirement applies to articles containing a chemical
substance or mixture if so required by the Administrator by a specific
rule under TSCA. At this time EPA is not proposing to require import
certification for these chemical substances as part of articles. The
EPA policy in support of import certification appears at 40 CFR part
707, subpart B.
VII. Applicability of Rule to Uses Occurring Before Effective Date of
the Final Rule
As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. If uses begun after publication of
the proposed rule were considered ongoing rather than new, it would be
difficult for EPA to establish SNUR notice requirements, because a
person could defeat the SNUR by initiating the proposed significant new
use before the document became final, and then argue that the use was
ongoing as of the effective date of the final rule. Thus, persons who
begin commercial manufacture or processing of the chemical substance(s)
that would be regulated through this proposed rule, if finalized, would
have to cease any such activity before the effective date of the rule
if and when finalized. To resume their activities, these persons would
have to comply with all applicable SNUR notice requirements and wait
until the notice review period, including all extensions, expires. Uses
arising after the publication of the proposed rule are distinguished
from uses that exist at publication of the proposed rule. The former
would be new uses, the latter ongoing uses, except that uses that are
ongoing as of the publication of the proposed rule would not be
considered ongoing uses if they have ceased by the date of issuance of
a final rule (as EPA expects for the LCPFAC chemical substances listed
in Table 1 of Unit I. and PFOA or its salts). To the extent that
additional ongoing uses are found in the course of rulemaking, EPA
would exclude those specific chemical substances for those specific
uses from the final SNUR. EPA has promulgated provisions to allow
persons to comply with the final SNUR before the effective date. If a
person were to meet the conditions of advance compliance under 40 CFR
721.45(h), that person would be considered to have met the requirements
of the final SNUR for those activities.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not usually require
developing any particular test data before submission of a SNUN. There
are two exceptions:
Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
Development of test data may be necessary where the
chemical substance has been listed under TSCA section 5(b)(4) (see TSCA
section 5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (15 U.S.C.
2604(d); 40 CFR 721.25; and 40 CFR 720.50). However, as a general
matter, EPA recommends that SNUN submitters include data that would
permit a reasoned evaluation of risks posed by the chemical substance
during its manufacture, processing, use, distribution in commerce, or
disposal. EPA encourages persons to consult with the Agency before
submitting a SNUN. As part of this optional pre-notice consultation,
EPA would discuss specific data it believes may be useful in evaluating
a significant new use. SNUNs submitted for significant new uses without
any test data may increase the likelihood that EPA will take action
under TSCA section 5(e) to prohibit or limit activities associated with
this chemical.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on:
1. Human exposure and environmental releases that may result from
the significant new uses of the chemical substance.
2. Potential benefits of the chemical substance.
[[Page 2893]]
3. Information on risks posed by the chemical substances compared
to risks posed by potential substitutes.
IX. SNUN Submissions
EPA recommends that submitters consult with the Agency prior to
submitting a SNUN to discuss what data may be useful in evaluating a
significant new use. Discussions with the Agency prior to submission
can afford ample time to conduct any tests that might be helpful in
evaluating risks posed by the substance. According to 40 CFR 721.1(c),
persons submitting a SNUN must comply with the same notice requirements
and EPA regulatory procedures as persons submitting a PMN, including
submission of test data on health and environmental effects as
described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No.
7710-25, generated using e-PMN software, and submitted to the Agency in
accordance with the procedures set forth in 40 CFR 721.25 and 40 CFR
720.40. e-PMN software is available electronically at https://www.epa.gov/opptintr/newchems.
X. Economic Analysis
A. SNUNs
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers and processors of
the chemical substance included in this proposed rule (Ref. 35). In the
event that a SNUN is submitted, costs are estimated at approximately
$8,589 per SNUN submission for large business submitters and $6,189 for
small business submitters. These estimates include the cost to prepare
and submit the SNUN, and the payment of a user fee. Businesses that
submit a SNUN would be subject to either a $2,500 user fee required by
40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual
sales of less than $40 million when combined with those of the parent
company (if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). The
costs of submission of SNUNs will not be incurred by any company unless
a company decides to pursue a significant new use as defined in this
proposed SNUR.
The proposed SNUR would require notification to EPA before the
importation of articles containing LCPFAC chemical substances listed in
Table 1 of Unit I. or PFOA and its salts. While not required by the
proposed SNUR, companies importing articles containing these chemical
substances may take additional steps to determine whether these
chemical substances are part of the articles they are considering to
import. Companies typically have an understanding of the contents of
the articles they import or process; however, there may be instances
when companies decide to gather additional information about these
articles from suppliers if not currently available. EPA believes that
the costs associated with such information gathering activities would
be minimal for this proposed SNUR because these chemical substances are
unlikely to be available for use in articles after December 31, 2015.
EPA's complete economic analysis is available in the public docket for
this proposed rule (Ref. 35).
B. Export Notification
Under TSCA section 12(b) and the implementing regulations at 40 CFR
part 707, subpart D, exporters must notify EPA if they export or intend
to export a chemical substance or mixture for which, among other
things, a rule has been proposed or promulgated under TSCA section 5.
For persons exporting a chemical substance that is the subject of a
SNUR, a one-time notice must be provided for the first export or
intended export to a particular country. The total costs of export
notification will vary by chemical, depending on the number of required
notifications (i.e., the number of countries to which the chemical
substance is exported). While EPA is unable to make any estimate of the
likely number of export notifications for the chemical substance
covered in this proposed rule SNUR, as stated in the accompanying EA of
this proposed SNUR, the estimated cost of the export notification
requirement on a per unit basis is $81.04.
C. Import Chemical Substances as Part of an Article
In proposing to make inapplicable the exemption relating to persons
that import certain chemical substances as part of an article, this
action may affect firms that plan to import types of articles that may
contain the subject chemical substance. Some firms have an
understanding of the contents of the articles they import. However, EPA
acknowledges that importers of articles may have varying levels of
knowledge about the chemical content of the articles that they import.
These parties may need to become familiar with the requirements of the
proposed rule. And, while not required by the SNUR, these parties may
take additional steps to determine whether the subject chemical
substances are part of the articles that they are considering to
import. This determination may involve activities such as gathering
information from suppliers along the supply chain, and/or testing
samples of the article itself. Costs vary across the activities chosen
and the extent of familiarity a firm has regarding the articles it
imports. Cost ranges are presented in the Agency's Economic Analysis
for this proposed rule (Ref. 35). Based on available information, EPA
believes that article importers that choose to investigate their
products would incur costs at the lower end of the ranges presented in
the Economic Analysis. For those companies choosing to undertake
actions to assess the composition of the articles they import, EPA
expects that importers would take actions that are commensurate with
the company's perceived likelihood that a chemical substance might be a
part of an article, and the resources it has available. Example
activities and their costs are provided in the accompanying Economic
Analysis of this proposed rule (Ref. 32).
XI. Alternatives
Before proposing this SNUR, EPA considered the following
alternative regulatory actions:
A. Promulgate a TSCA Section 8(a) Reporting Rule
Under a TSCA section 8(a) rule, EPA could, among other things,
generally require persons to report information to the Agency when they
intend to manufacture or process a listed chemical for a specific use
or any use. However, for LCPFAC and PFAS chemical substances, the use
of TSCA section 8(a) rather than SNUR authority would have several
limitations. First, if EPA were to require reporting under TSCA section
8(a) instead of TSCA section 5(a), EPA would not have the opportunity
to review human and environmental hazards and exposures associated with
the proposed significant new use and, if necessary, take immediate
follow-up regulatory action under TSCA section 5(e) or 5(f) to prohibit
or limit the activity before it begins. In addition, EPA may not
receive important information from small businesses, because such firms
generally are exempt from TSCA section 8(a) reporting requirements. In
view of the level of health and environmental concerns about LCPFAC and
PFAS chemical substances if used for the proposed significant new use,
EPA believes that a TSCA section 8(a) rule for this chemical substance
would not meet EPA's regulatory objectives.
[[Page 2894]]
B. Regulate LCPFAC Chemical Substances Under TSCA Section 6
EPA may regulate under TSCA section 6 if ``the Administrator finds
that there is a reasonable basis to conclude that the manufacture,
processing, distribution in commerce, use or disposal of a chemical
substance or mixture . . . presents or will present an unreasonable
risk of injury to health or the environment.'' (TSCA section 6(a)).
Given that these chemical substances are believed to be phasing out,
EPA concluded that risk management action under TSCA section 6 is not
necessary at this time. However, if EPA determines that there are
persons who intend to manufacture or process these chemicals, EPA may
decide to regulate LCPFAC chemical substances under TSCA section 6.
This proposed SNUR would allow the Agency to address the potential
risks associated with the proposed significant new use.
XII. Request for Comment
A. Do you have comments or information about ongoing uses?
EPA welcomes comments on any aspect of this proposed SNUR. EPA
particularly requests comment on whether any of the current uses of any
of the specific LCPFAC chemical substances identified in Table 1 of
Unit I. will continue to be ongoing after December 31, 2015, or whether
there are any ongoing uses of those identified in Table 2 of Unit I.
EPA also requests comment on whether there are currently any ongoing
uses, including use as part of articles, of any of the remaining LCPFAC
chemical substances that were not identified in the 2012 CDR. EPA would
welcome specific documentation of any such ongoing use.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. It is EPA's policy to include all comments
received in the public docket without change or further notice to the
commenter and to make the comments available online at https://www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be CBI or other
information whose disclosure is restricted by statute. Do not submit
this information to EPA through regulations.gov or email. Clearly mark
the part or all of the information that you claim to be CBI. For CBI
information in a disk or CD-ROM that you mail to EPA, mark the outside
of the disk or CD-ROM as CBI and then identify electronically within
the disk or CD-ROM the specific information that is claimed as CBI. In
addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2, subpart B.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
XIII. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are in the docket, even if the
referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Long-Chain Perfluorinated Chemicals Action Plan. December
30, 2009.
2. EPA. 2010/2015 PFOA Stewardship Program. 2006. https://www.epa.gov/oppt/pfoa/pubs/stewardship/.
3. Rizzuto, Pat. DuPont Ceases PFOA Manufacture, Is on Track to Stop
All Uses By End of 2014. Bloomberg BNA Daily Environmental Report.
December 5, 2013.
4. 3M Company. Perfluorooctane Sulfonate: Current Summary of Human
Sera, Health and Toxicology Data. St. Paul, Minnesota. January 21,
1999.
5. Washington, J.W., et al. Degradability of an Acrylate-Linked
Fluorotelomer Polymer in Soil. Environmental Science and Technology.
43: 6617-6623. 2009.
6. EPA. PFOA Stewardship Program Baseline Year Summary Report. 2007.
https://epa.gov/oppt/pfoa/pubs/stewardship/sumrpt.html#background.
7. EPA. Industry Progressing in Voluntary Effort to Reduce Toxic
Chemicals. February 10, 2012.
8. EPA. Perfluoroalkyl Sulfonates; Significant New Use Rule. Final
Rule. Federal Register (67 FR 72854, December 9, 2002) (FRL-7279-1).
9. EPA. Perfluoroalkyl Sulfonates; Significant New Use Rule. Final
Rule. Federal Register (72 FR 57222, October 9, 2007) (FRL-8150-4).
10. EPA. Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl
Carboxylate Chemical Substances; Proposed Significant New Use Rule;
Proposed Rule. Federal Register (77 FR 48924, August 15, 2012) (FRL-
9358-7).
11. Butt, C.M., et al. Levels and Trends of Poly- and Perfluorinated
Compounds in the Arctic Environment. Science Total Environment. 408:
2936-2965. 2010.
12. Houde M., et al. Biological Monitoring of Polyfluoroalkyl
Substances: A Review. Environmental Science and Technology. 40:
3463-3473. 2006.
13. Calafat A.M., et al. Polyfluoroalkyl Chemicals in the U.S.
Population: Data From the National Health and Nutrition Examination
Survey (NHANES) 2003-2004 and Comparisons with NHANES 1999-2000.
Environmental Health Perspective. 115(11), 1596-1602. 2007.
14. Lau C., et al. Effects of Perfluoroctanoic Acid Exposure During
Pregnancy in the Mouse. Toxicology Science. 90(2): 510-518. 2006.
15. Lau C., et al. Perfluoroalkyl Acids: A Review of Monitoring and
Toxicological Findings. Toxicological Sciences. 99(2): 366-394.
2007.
16. Ahrens L., et al. Polyfluoroalkyl Compounds in the Aquatic
Environment: A Review of Their Occurrence and Fate. Journal of
Environmental Monitoring. 13: 20-31. 2011.
17. Sturm R., et al. Trends of Polyfluoroalkyl Compounds in Marine
Biota and in Humans. Environmental Chemistry. 7: 457-484. 2010.
18. Lau, C. Perfluorinated Compounds. Molecular, Clinical and
Environmental Toxicology Experientia Supplementum. Volume 101, pp.
47-86. 2012.
19. Yoo, H., et al. Concentrations, Distribution and Persistence of
Fluorotelomer Alcohols in Sludge-applied Soils Near Decatur,
Alabama, USA. Environmental Science & Technology. 44: 8397-8402.
2010.
20. Washington, J.W., et al. Concentrations, Distribution and
Persistence of Perfluoroalkylates in Sludge-applied Soils Near
Decatur, Alabama, USA. Environmental Science and Technology. 44:
8390-8396. 2010.
21. Kudo, N., et.al. Comparison of the Elimination Between
Perfluorinated Fatty Acids with Different Carbon Chain
[[Page 2895]]
Lengths in Rats. Chemico-Biological Interactions. Volume 134(2), pp.
203-216. 2001.
22. Goecke-Flora, C.M., et al. Influence of Carbon Chain Length on
the Hepatic Effects of Perfluorinated Fatty Acids, A\19\ F- and
\31\P-NMR Investigation. Chemical Research in Toxicology. 9(4), pp.
689-695. 1996.
23. Lasier, P.J., et al. Perfluorinated Chemicals in Surface Waters
and Sediments from Northwest Georgia, USA, and Their Bioaccumulation
in Lumbriculus Variegates. Environmental Toxicology andChemistry.
30: 2194-2201. 2011.
24. 3M Company. Fluorochemical Use, Distribution, and Release
Overview. St. Paul, Minnesota. May 26, 1999.
25. Lua, C. Perfluorinated Compounds. Molecular, Clinical and
Environmental Toxicology Experientia Supplementum. Volume 101, pp.
47-86. 2012.
26. EPA. Perfluoroalkyl Sulfonates; Proposed Significant New Use
Rule; Proposed Rule. Federal Register (67 FR 11014, March 11, 2002)
(FRL-6823-7).
27. EPA. Perfluoroalkyl Sulfonates; Significant New Use Rule; Final
Rule. Federal Register (67 FR 11008, March 11, 2002) (FRL-6823-6).
28. 3M Company. The Science of Organic Fluorochemistry. St. Paul,
Minnesota. February 5, 1999.
29. Centers for Disease Control and Prevention. Fourth National
Report on Human Exposure to Environmental Chemicals. Updated Tables.
March 2013.
30. EPA. Perfluoroalkyl Sulfonates; Significant New Use Rule;
Proposed Rule. Federal Register (65 FR 62319, October 18, 2000)
(FRL-6745-5).
31. EPA. Perfluoroalkyl Sulfonates; Proposed Significant New Use
Rule; Proposed Rule. Federal Register (71 FR 12311, March 10, 2006)
(FRL-7740-6).
32. Kato, K. et al. Trends in Exposure to Polyfluoroalkyl Chemicals
in the U.S. Population: 1999-2008. Environmental Science and
Technology. 45: 8037-8045. 2011.
33. Hubbard, H. et al. Removal of Perfluorocarboxylic Acids (PFCAs)
from Carpets Treated with Stain-Protection Products by Using Carpet
Cleaning Machines. EPA, Report EPA/600-12/703. 2012.
34. Liu, X. et al. Trends of Perfluoroalkyl Acid Content in Articles
of Commerce. EPA, Report EPA/600/R-12/585. 2012.
35. EPA. Economic Analysis of the Significant New use Rule for Long-
Chain Perfluoroalkyl Carboxylate Chemical Substances. August 20,
2013.
36. EPA. Modification of Significant New Use Rules for Certain
Substances; Final Rule. Federal Register (62 FR 42690, August 8,
1997) (FRL-5735-4).
XIV. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This proposed SNUR has been designated by the Office of Management
and Budget (OMB) as a ``significant regulatory action'' under section
3(f) of Executive Order 12866 (58 FR 51735, October 4, 1993).
Accordingly, EPA submitted this proposed action to OMB for review under
Executive Order 12866 and 13563 (76 FR 3821, January 21, 2011), and any
changes made in response to OMB recommendations are documented in the
docket.
B. Paperwork Reduction Act (PRA)
This action would not impose any new information collection burden
under PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 1320.3(b).
The information collection activities associated with existing chemical
SNURs are already approved by OMB under OMB control number 2070-0038
(EPA ICR No. 1188); and the information collection activities
associated with export notifications are already approved by OMB under
OMB control number 2070-0030 (EPA ICR No. 0795). If an entity were to
submit a SNUN to the Agency, the annual burden is estimated to be less
than 100 hours per response, and the estimated burden for an export
notifications is less than 1.5 hours per notification. In both cases,
burden is estimated to be reduced for submitters who have already
registered to use the electronic submission system. Additional burden,
estimated to be less than 10 hours, could be incurred where additional
recordkeeping requirements are specified under 40 CFR 721.125(a), (b),
and (c).
An Agency may not conduct or sponsor, and a person is not required
to respond to a collection of information that requires OMB approval
under PRA, unless it has been approved by OMB and displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register, are
listed in 40 CFR part 9, and included on the related collection
instrument, or form, if applicable.
C. Regulatory Flexibility Act (RFA)
Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., I hereby
certify that promulgation of this proposed SNUR would not have a
significant economic impact on a substantial number of small entities.
The rationale supporting this conclusion is as follows.
EPA generally finds that proposed and final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities (See, e.g., Ref. 36). Since these proposed SNURs would require
a person who intends to engage in such activity in the future to first
notify EPA by submitting a SNUN, no economic impact would occur unless
someone files a SNUN to pursue a significant new use in the future or
forgoes profits by avoiding or delaying the significant new use.
Although some small entities may decide to engage in such activities in
the future, EPA cannot presently determine how many, if any, there may
be. However, EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemical substances, the
Agency receives only a handful of notices per year. During the six year
period from 2005-2011, only three submitters self-identified as small
in their SNUN submission (Ref. 35). EPA believes the cost of submitting
a SNUN is relatively small compared to the cost of developing and
marketing a chemical new to a firm and that the requirement to submit a
SNUN generally does not have a significant economic impact.
A SNUR applies to any person (including small or large entities)
who intends to engage in any activity described in the rule as a
``significant new use.'' EPA has preliminarily determined, based in
part, on the Agency's market research, that these chemical substances
are not being manufactured (including imported) or processed for a
significant new use. This preliminary determination also includes
importation of these chemical substances as part of articles for the
significant new use (Unit IV.).
In addition, given existing regulatory limitations both
internationally and within the U.S., industry-wide processes, resources
that support companies in understanding and managing their supply
chains, and the evidence showing minimal worldwide availability of the
LCPFACs regulated under the SNUR, EPA believes that there will be
minimal impact to importers of these chemical substances as part of
articles from this proposed SNUR. Therefore, based on current
knowledge, EPA has preliminarily determined that these uses, including
the importation of these chemical substances as part of articles, are
not ongoing, and that no small entities presently manufacture for the
significant new uses addressed in this proposed rule. EPA will consider
[[Page 2896]]
information received during the comment period that might indicate that
this preliminary determination is incorrect. The SNUR does not require
importers of articles to conduct specific activities to ascertain if
they are importing an article that uses a chemical subject to the
proposed rule. EPA expects importers would take actions that are
commensurate with their perceived likelihood of a chemical substance
subject to the SNUR being part of an article, and the resources it has
available. EPA has no reason to believe that a firm would voluntarily
incur substantial costs to comply with the SNUR, but rather each firm
will choose the most efficient route to identify whether it is
importing the subject chemical substances in articles.
Therefore, EPA believes that the potential economic impact of
complying with this proposed SNUR is not expected to be significant or
adversely impact a substantial number of small entities.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reason to believe that any
State, local, or Tribal government would be impacted by this proposed
rulemaking. As such, the requirements of UMRA sections 202, 203, 204,
or 205, 2 U.S.C. 1531-1538, do not apply to this proposed action.
E. Executive Order 13132: Federalism
This action would not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This proposed rule does not have Tribal implications because it is
not expected to have any effect (i.e., there would be no increase or
decrease in authority or jurisdiction) on Tribal governments, on the
relationship between the Federal Government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes. Thus, Executive Order 13175 (65 FR 67249,
November 9, 2000) does not apply to this proposed rule.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This proposed action is not subject to Executive Order 13045 (62 FR
19885, April 23, 1997), because this proposed action is not intended to
address environmental health or safety risks for children.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This proposed rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001), because this action is not expected to affect
energy supply, distribution, or use.
I. National Technology Transfer Advancement Act (NTTAA)
Since this proposed action does not involve any technical
standards, section 12(d) of the NTTAA, 15 U.S.C. 272 note, does not
apply to this proposed action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This proposed action does not entail special considerations of
environmental justice related issues as delineated by Executive Order
12898 (59 FR 7629, February 16, 1994), because EPA has determined that
this proposed action would not have disproportionately high and adverse
human health or environmental effects on minority or low-income
populations. This proposed action would not affect the level of
protection provided to human health or the environment.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: December 18, 2014.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. In Sec. 721.9582:
0
a. Redesignate paragraph (a) as (b).
0
b. Add new paragraph (a).
0
c. Revise newly designated paragraph (b)(2)(iv).
0
d. Add paragraph (c).
The amendments read as follows:
Sec. 721.9582 Certain perfluoroalkyl sulfonates.
(a) Definitions. The definitions in Sec. 721.3 apply to this
section. In addition, the following definition applies:
Carpet means a finished fabric or similar product intended to be
used as a floor covering. This definition excludes resilient floor
coverings such as linoleum and vinyl tile.
(b) * * *
(2) * * *
(iv) Import as part of carpets.
* * * * *
(c) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (c).
(1) Revocation of certain notification exemptions. With respect to
imports of carpets, the provisions of Sec. 721.45(f) do not apply to
this section. A person who imports a chemical substance identified in
this section as part of a carpet is not exempt from submitting a
significant new use notice. The other provision of Sec. 721.45(f),
respecting processing a chemical substance as part of an article,
remains applicable.
(2) [Reserved]
0
3. Revise Sec. 721.10536 to read as follows:
Sec. 721.10536 Long-chain perfluoroalkyl carboxylate chemical
substances.
(a) Definitions. The definitions in Sec. 721.3 apply to this
section. In addition, the following definition applies:
Carpet means a finished fabric or similar product intended to be
used as a floor covering. This definition excludes resilient floor
coverings such as linoleum and vinyl tile.
(b) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified below, where 5 < n <
21 or 6 < m < 21, are subject to reporting under this section for the
significant new uses described in paragraph (b)(4)(i) and (b)(4)(iv) of
this section.
(i) CF3(CF2)n-COO\-\M where M =
H\+\ or any other group where a formal dissociation can be made.
(ii) CF3(CF2)n-CH=CH2.
(iii) CF3(CF2)n-C(=O)-X where X is
any chemical moiety.
(iv) CF3(CF2)m-CH2-X
where X is any chemical moiety.
(v) CF3(CF2)m-Y-X where Y = non-S,
non-N heteroatom and where X is any chemical moiety.
(2) The chemical substances listed in Table 1 of this paragraph are
subject to reporting under this section for the significant new uses
described in paragraph (b)(4)(ii) of this section.
[[Page 2897]]
Table 1--LCPFAC Chemical Substances Subject to Reporting After December 31, 2015
----------------------------------------------------------------------------------------------------------------
CAS registry no. (CASRN) Accession no. Chemical name
----------------------------------------------------------------------------------------------------------------
507-63-1............................. No Accession Number.... Octane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-
heptadecafluoro-8-iodo-
678-39-7............................. No Accession Number.... 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
heptadecafluoro-
865-86-1............................. No Accession Number.... 1-Dodecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,1
2-heneicosafluoro-
2043-53-0............................ No Accession Number.... Decane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-
heptadecafluoro-10-iodo-
2043-54-1............................ No Accession Number.... Dodecane,
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10 ,10-
heneicosafluoro-12-iodo-
17741-60-5........................... No Accession Number.... 2-Propenoic acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,
12,12,12-heneicosafluorododecyl ester
27905-45-9........................... No Accession Number.... 2-Propenoic acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
heptadecafluorodecyl ester
30046-31-2........................... No Accession Number.... Tetradecane,
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,
11,12,12-pentacosafluoro-14-iodo-
39239-77-5........................... No Accession Number.... 1-Tetradecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,1
3,13,14,14,14-pentacosafluoro-
60699-51-6........................... No Accession Number.... 1-Hexadecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,1
3,13,14,14,15,15,16,16,16-nonacosafluoro-
65510-55-6........................... No Accession Number.... Hexadecane,
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,
11,12,12,13,13,14,14-nonacosafluoro-16-iodo-
68187-47-3........................... No Accession Number.... 1-Propanesulfonic acid, 2-methyl-, 2-[[1-oxo-3-
[(.gamma.-.omega.-perfluoro- C4-16-
alkyl)thio]propyl]amino] derivs., sodium salts
68391-08-2........................... No Accession Number.... Alcohols, C8-14, .gamma.-.omega.-perfluoro
70969-47-0........................... No Accession Number.... Thiols, C8-20, .gamma.-.omega.-perfluoro,
telomers with acrylamide
125476-71-3.......................... No Accession Number.... Silicic acid (H4SiO4), sodium salt (1:2),
reaction products with chlorotrimethylsilane
and 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
heptadecafluoro-1-decanol
1078712-88-5......................... No Accession Number.... Thiols, C4-20, .gamma.-.omega.-perfluoro,
telomers with acrylamide and acrylic acid,
sodium salts
1078715-61-3......................... No Accession Number.... 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-
dimethyl-, N-[2-[(.gamma.-.omega.-perfluoro-C4-
20-a lkyl)thio]acetyl] derivs., inner salts
CBI.................................. 71217.................. Polyfluoroalkyl betaine
CBI.................................. 89419.................. Modified fluoroalkyl urethane
CBI.................................. 274147................. Perfluorinated polyamine
----------------------------------------------------------------------------------------------------------------
CBI = Confidential Business Information. CAS or CASRN = Chemical Abstracts Service Registry Number.
(3) The chemical substances identified as perfluorooctanoic acid
(PFOA) and its salts, including those listed in Table 2 of this
paragraph, are subject to reporting under this section for the
significant new uses described in paragraph (b)(4)(iii) of this
section.
Table 2--PFOA and Examples of Its Salts
------------------------------------------------------------------------
CAS registry no. (CASRN) Chemical name
------------------------------------------------------------------------
335-66-0..................... Octanoyl fluoride, pentadecafluoro-
335-67-1..................... Octanoic acid, pentadecafluoro- (PFOA)
335-93-3..................... Octanoic acid, pentadecafluoro-, silver
salt
335-95-5..................... Octanoic acid, pentadecafluoro-, sodium
salt
2395-00-8.................... Octanoic acid, pentadecafluoro-,
potassium salt
3825-26-1.................... Octanoic acid, pentadecafluoro-, ammonium
salt (APFO)
------------------------------------------------------------------------
CAS or CASRN = Chemical Abstracts Service Registry Number.
(4) Significant new uses. (i) The significant new use for chemical
substances identified in paragraph (b)(1) of this section are:
Manufacture (including import) or processing for use as part of carpets
or to treat carpets (e.g., for use in the carpet aftercare market).
(ii) The significant new use for chemical substances identified in
paragraph (b)(2) of this section are: Manufacture (including import) or
processing for any use after December 31, 2015.
(iii) The significant new use for chemical substances identified in
paragraph (b)(3) of this section are: Manufacture (including import) or
processing for any use. Import of fluoropolymer dispersions and
emulsions, and fluoropolymers as part of articles, containing chemical
substances identified in paragraph (b)(3) of this section shall not be
considered as a significant new use subject to reporting.
(iv) The significant new use for chemical substances identified in
paragraph (b)(1) of this section, except for those chemicals identified
in Table 1 of paragraph (b)(2) of this section are: Manufacture
(including import) or processing for any use other than that use
already covered by paragraph (b)(4)(i) of this section.
(c) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (c).
(1) Revocation of certain notification exemptions. With respect to
imports of carpets, the provisions of Sec. 721.45(f) do not apply to
this section. With respect to imports of articles, the provisions of
Sec. 721.45(f) also do not apply to a chemical substance identified in
paragraphs (b)(2) or (b)(3) of this section. A person who imports a
chemical substance identified in paragraph (b)(1) of this section as
part of a carpet or who imports a chemical substance identified in
paragraphs (b)(2) or (b)(3) of this section as part of an article is
not exempt from submitting a significant new use notice. The other
[[Page 2898]]
provision of Sec. 721.45(f), respecting processing a chemical
substance as part of an article, remains applicable.
(2) [Reserved]
[FR Doc. 2015-00636 Filed 1-20-15; 8:45 am]
BILLING CODE 6560-50-P
