[Federal Register Volume 85, Number 42 (Tuesday, March 3, 2020)]
[Proposed Rules]
[Pages 12479-12489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03865]
[[Page 12479]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2013-0225; FRL-10003-21]
RIN 2070-AJ99
Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl
Sulfonate Chemical Substances; Significant New Use Rule; Supplemental
Proposal
AGENCY: Environmental Protection Agency (EPA).
ACTION: Supplemental notice of proposed rulemaking.
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SUMMARY: EPA is supplementing a proposed significant new use rule
(SNUR) issued under section 5(a)(2) of the Toxic Substances Control Act
(TSCA) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical
substances to make inapplicable the exemption for persons who import a
subset of LCPFAC chemical substances as part of surface coatings on
articles. This subset of LCPFAC chemical substances also includes the
salts and precursors of these perfluorinated carboxylates. This
supplemental proposal would require importers to notify EPA at least 90
days before commencing the import of these chemical substances in
certain articles for the significant new use described in this
document. The required significant new use notification would initiate
EPA's evaluation of the conditions of use associated with the intended
significant new use. Manufacturing (including import) or processing for
the significant new use would be prohibited from commencing until EPA
has conducted a review of the notice, made an appropriate determination
on the notice, and taken such actions as are required in association
with that determination.
DATES: Comments must be received on or before April 17, 2020.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2013-0225, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be 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 http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Tyler Lloyd, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-4016; email address:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
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), process, or distribute in commerce chemical
substances and mixtures. The following list of North American
Industrial Classification System (NAICS) codes is not intended to be
exhaustive, but rather provides a guide to help readers determine
whether this document applies to them.
Potentially affected entities may include:
Apparel Manufacturing (NAICS code 315).
Electrical Equipment, Appliance, and Component
Manufacturing (NAICS code 335).
Merchant Wholesalers, Durable Goods (NAICS codes 423).
Merchant Wholesalers, Nondurable Goods (NAICS 424).
Furniture and Home Furnishings Stores (NAICS codes 442).
Electronics and Appliance Stores (NAICS codes 443).
Building Material and Garden Equipment and Supplies
Dealers (NAICS code 444).
Clothing and Clothing Accessories Stores (NAICS code 448).
Sporting Goods, Hobby, Musical Instrument, and Book Stores
(NAICS code 449).
General Merchandise Stores (NAICS code 450).
Non-store Retailers (NAICS code 451).
This action may 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.
Additionally, persons who export or intend to export a chemical
substance that is the subject of a proposed or final SNUR are subject
to the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b); see also 40 CFR part 707, subpart D and 40 CFR 721.20). Under
the existing TSCA import certification and export notification rules,
persons who import a chemical substance covered under this proposed
rule as part of an article would be exempt from TSCA section 13 import
certification, and persons who export or intend to export a chemical
substance as part of an article would be exempt from the TSCA section
12(b) export notification requirements. See Unit V. for more
information on the applicability of the import certification and export
notification requirements.
If you have any questions regarding the applicability of this
action to a particular entity, consult the technical information
contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (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).
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) 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.
[[Page 12480]]
The extent to which a use increases the magnitude and
duration of exposure 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. Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1) requires persons to submit a significant new
use notice (SNUN) to EPA at least 90 days before they manufacture
(including import) or process the chemical substance for that use (15
U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing
or processing from commencing until EPA has conducted a review of the
notice, made an appropriate determination on the notice, and taken such
actions as are required in association with that determination (15
U.S.C. 2604(a)(1)(B)(ii)). Additionally, TSCA section 5(a)(5) (15
U.S.C. 2604(a)(5)), as amended in 2016, authorizes EPA to require
notification for the import or processing of a chemical substance as
part of an article or category of articles under TSCA section 5(a)(1)
(15 U.S.C. 2604(a)(1)(A)(ii)) if EPA makes an affirmative finding in a
rule under TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) that the
reasonable potential for exposure to the chemical substance through the
article or category of articles subject to the rule justifies
notification. This supplemental proposal proposes to exercise EPA's
authority under TSCA section 5(a)(5) to require notification for the
import of the subject chemical substances as part of the category of
articles, articles that contain certain LCPFAC chemical substances as
part of a surface coating, discussed in Unit I.C. 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?
In the Federal Register of January 21, 2015 (80 FR 2885) (FRL-9915-
63) (Ref. 1), EPA proposed a SNUR for long-chain perfluoroalkyl
carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances.
As stated in the previous proposal, the LCPFAC chemical substances also
include the salts and precursors of these perfluorinated carboxylates.
In that previously proposed rule, EPA proposed to make the exemption
from notification requirements for persons who import the chemical
substance as part of an article inapplicable for the import of a subset
of LCPFAC chemical substances in all articles. EPA is now issuing a
supplemental proposal for the import of certain LCPFAC chemical
substances; this action would make the exemption from notification
requirements inapplicable and require significant new use notification
reporting for the import of a subset of LCPFAC chemical substances only
as part of a surface coating on articles. This supplemental proposal
better defines the articles subject to the rule by defining the subject
articles as ``imported articles where certain LCPFAC chemical
substances are part of surface coating on the articles'' rather than
what was originally proposed, ``imports of articles.'' EPA is issuing
this supplemental proposal to be responsive to the article
consideration provision at TSCA section 5(a)(5), added with the passage
of the Frank R. Lautenberg Chemical Safety for the 21st Century Act
(Pub. L. 114-182), which states that articles can be subject to
notification requirements as a significant new use if the Administrator
makes an affirmative finding in a rule that the reasonable potential
for exposure to a chemical from an article or category of articles
justifies notification. Rather than making the article exemption
inapplicable for any article, as was proposed in the January 21, 2015,
proposal (Ref. 1), this action proposes to make a finding under TSCA
section 5(a)(5) and make the article exemption at 40 CFR 721.45(f)
inapplicable for persons importing the category of articles that
contain certain LCPFAC chemical substances as part of a surface coating
on articles. As to processors, it is EPA's understanding that there is
no ongoing manufacturing or processing of LCPFAC chemical substances in
the U.S. Based on that understanding, EPA does not expect that there
would be any future such processing, and EPA therefore is not proposing
that this Supplemental Proposed Rule apply to processors. EPA seeks
comment on this approach.
In the proposed rule issued in the Federal Register of January 21,
2015 (Ref. 1), EPA also proposed: (1) An amendment to a SNUR for LCPFAC
chemical substances by designating as a significant new use
manufacturing (including importing) or processing of a subset of LCPFAC
chemical substances for any use that was no longer ongoing after
December 31, 2015; (2) an amendment to a SNUR for LCPFAC chemical
substances by designating as a significant new use manufacturing
(including importing) or processing of all other LCPFAC chemicals
substances for any use that was no longer ongoing after January 21,
2015; and (3) an amendment to a SNUR for perfluoroalkyl sulfonate
chemical substances that would make inapplicable the exemption from
notification requirements for persons who import perfluoroalkyl
sulfonate chemical substances as part of carpets. These other
amendments, as proposed on January 21, 2015 (Ref. 1), are not the
subject of this supplemental proposal. EPA is considering the comments
received on the January 21, 2015, proposal (Ref. 1) and will respond to
them with publication of the final rule.
During the public comment period for the rule proposed in the
Federal Register of January 21, 2015 (Ref. 1), EPA received comments
about ongoing uses of LCPFAC and perfluorooctanoic acid (PFOA) chemical
substances and requests that EPA modify the proposed SNUR to
specifically recognize and exclude from the significant new uses
certain ongoing activities. EPA received public comments claiming
several ongoing uses. EPA continues to review these claims of ongoing
use to understand whether these uses remain ongoing. EPA intends to
undertake further outreach to commenters to confirm and better
understand the ongoing uses. In the final rule, EPA will recognize and
exclude from the significant new uses any ongoing activities for these
chemicals. The final rule would take final action on both the
previously proposed rule and this supplemental proposal. For further
background information for this supplemental proposal, consult the
proposal issued in the Federal Register of January 21, 2015 (Ref. 1)
and the corresponding docket for this rulemaking (EPA-HQ-OPPT-2013-
0225).
This supplemental proposal to the proposed SNUR would require
persons who intend to import these LCPFAC chemical substances as part
of a surface coating on articles for a significant new use, consistent
with the requirements at 40 CFR 721.25, to notify EPA at least 90 days
before commencing such import. This supplemental proposal to the
proposed SNUR would furthermore preclude the commencement of import of
such articles until EPA has conducted a review of the notice, made an
appropriate determination on the notice, and taken such actions as are
required in association with that determination. As discussed in the
Federal Register of April 24, 1990 (55 FR 17376), EPA has decided that
the intent of the TSCA section 5(a)(1)(B) is best served by designating
a use as a significant new
[[Page 12481]]
use as of the date of publication of the proposed rule rather than as
of the effective date of the final rule. This rule was proposed on
January 21, 2015. 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.
D. Why is the Agency taking this action?
Enacted on June 22, 2016, the Frank R. Lautenberg Chemical Safety
for the 21st Century Act (Pub. L. 114-182) amended several sections of
TSCA and added section 5(a)(5), Article Consideration. As a
precondition to authorizing EPA to ``require notification under this
section for the import or processing of a chemical substance as part of
an article or category of articles under paragraph (1)(A)(ii),'' this
provision requires that EPA affirmatively find in a rule under section
5(a)(2) that the reasonable potential for exposure to a chemical
substance through the article or category of articles justifies
notification. After considering the reasonable potential for exposure
from articles under TSCA section 5(a)(5), EPA is now issuing a
supplemental proposal to make inapplicable the exemption for persons
who import certain LCPFAC chemical substances when those LCPFAC
chemical substances are part of a surface coating on articles.
If finalized as proposed, the January 21, 2015, proposed SNUR would
require timely advance notice to EPA of any future import of LCPFAC
chemical substances for new uses that may produce changes in human and
environmental exposures, and would ensure that an appropriate
determination (relevant to the risks associated with such importing,
processing, and use) has been issued prior to the commencement of such
importing. The proposed SNUR is furthermore necessary to ensure that
manufacturing (including importing) or processing for the significant
new use cannot proceed until EPA has responded to the circumstances by
taking the required actions under TSCA sections 5(e) or 5(f) in the
event that EPA determines any of the following: (1) That the
significant new use presents an unreasonable risk under the conditions
of use (without consideration of costs or other non-risk factors, and
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant by EPA); (2) that the information
available to EPA is insufficient to permit a reasoned evaluation of the
health and environmental effects of the significant new use; (3) that,
in the absence of sufficient information, the manufacturing (including
importing), processing, distribution in commerce, use, or disposal of
the substance, or any combination of such activities, may present an
unreasonable risk (without consideration of costs or other non-risk
factors, and including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant by EPA); or (4) that
there is substantial production and sufficient potential for
environmental release or human exposure (as defined in TSCA section
5(a)(3)(B)(ii)(II)).
The rationale and objectives for this supplemental proposal 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 importers of articles containing
the chemical substances included in this supplemental proposal when
they are part of a surface coating on articles. This analysis (Ref. 2),
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
approximately $23,000 per SNUN submission for large business submitters
and about $10,000 for small business submitters. The rule may also
affect firms that plan to import or process articles that may be
subject to the SNUR. Although there are no specific requirements in the
rule for these firms, they may choose to undertake some activity to
assure themselves that they are not undertaking a significant new use.
In the accompanying Economic Analysis for this SNUR (Ref. 2), EPA
provides example steps (and their respective costs) that an importer or
processor might take to identify LCFPAC chemical substances in
articles. 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; thus, potential total costs were not estimated.
F. Do you have comments or information about ongoing uses?
EPA welcomes comment on all aspects of this supplemental proposal.
EPA based its understanding of the use profile of these chemicals on
the published literature, company progress reports submitted during the
2010/2015 PFOA Stewardship Program, the 2016 CDR submissions, market
research, and review of Safety Data Sheets. To confirm EPA's
understanding, the Agency is requesting public comment on all aspects
of this supplemental proposal. In providing comments on the reasonable
potential for exposure to LCPFAC chemical substances in articles,
commenters are urged to provide sufficient information for EPA to
substantiate any assertions of use and of exposure. Additionally, EPA
requests comment on the assumption that article importers that choose
to investigate their products will incur costs at the lower end of the
ranges presented in the Economic Analysis for this supplemental
proposed rule.
G. Additional Considerations for Comment
TSCA section 5(a)(5) provides that the EPA Administrator ``may
require notification under this section for the import or processing of
a chemical substance as part of an article or category of articles
under paragraph (1)(A)(ii) if the Administrator makes an affirmative
finding in a rule under paragraph (2) that the reasonable potential for
exposure to the chemical substance through the article or category of
articles subject to the rule justifies notification.'' (Emphasis
added.) Thus, Congress provided EPA with considerable discretion to
determine (1) what is a ``reasonable'' potential for exposure; (2) what
kind of reasonable potential ``justifies'' notification; and (3)
whether, in EPA's discretion (``may require''), to require notification
in a case in which such a reasonable potential exists. By making
notification contingent on the existence of a ``reasonable'' potential
for exposure, TSCA section 5(a)(5) implies that there is some category
of less than reasonable potentials for exposure that could not give
rise to notification.
EPA requests comment on whether or not the Agency should
affirmatively establish an explicit threshold at which, or explicit
criteria for determining whether, a significant new use exhibits a
reasonable potential for exposure that justifies notification. While
TSCA section 5(a)(5) does not establish a specific threshold or
specific criteria for making this determination and does not
[[Page 12482]]
require EPA to affirmatively establish such a threshold or such
criteria, EPA may establish a threshold, or criteria, for determining
reasonable potential for exposure if appropriate.
EPA seeks comment on whether EPA could adopt a de minimis threshold
for determining ``reasonable potential for exposure'' and if so, how
that de minimis threshold could be established. For example, the United
States Court of Appeals for the District of Columbia Circuit has
recognized that ``[u]nless Congress has been extraordinarily rigid,
there is likely a basis for an implication of de minimis authority to
provide exemption when the burdens of regulation yield a gain of
trivial or no value.'' Alabama Power Co. v. Costle, 636 F.2d 323, 360-
61 (D.C. Cir. 1980).
In Alabama Power, the Court has recognized that ``[c]ategorical
exemptions from statutory commands may . . . be permissible as an
exercise of agency power, inherent in most statutory schemes, to
overlook circumstances that in context may fairly be considered de
minimis. It is commonplace, of course, that the law does not concern
itself with trifling matters, and this principle has often found
application in the administrative context. Courts should be reluctant
to apply the literal terms of a statute to mandate pointless
expenditures of effort.'' 636 F.2d at 360 (citations omitted). ``The
ability . . . to exempt de minimis situations from a statutory command
is not an ability to depart from the statute, but rather a tool to be
used in implementing the legislative design.'' Id. Courts have
continued to recognize that authority to create de minimis exemptions
may be implied where ``the burdens of regulation yield a gain of
trivial or no value.'' Envtl. Def. Fund, Inc. v. EPA, 82 F.3d 451, 466
(D.C. Cir. 1996) (internal quotation marks omitted); see also, e.g.,
Ass'n of Admin Law Judges v. FLRA, 397 F.3d 957, 961-62 (D.C. Cir.
2005). As an application of the statutory requirements in the context
of this specific Significant New Use Rule, EPA could set a specific
threshold level for the content of the LCPFAC below which reporting
would not be required (in percentage of the product composition for
example). EPA requests comment both on how this threshold level could
be determined, and on what such levels might be. Establishment of a
threshold could be based on one or more of the following rationales:
(1) Below the selected threshold level, there is no ``reasonable
potential for exposure'' within the meaning of section 5(a)(5) (i.e.,
the risk of exposure is very low); and (2) below the selected threshold
level, there is a ``reasonable potential for exposure'' (or,
alternatively, there may be such a potential), but the potential does
not ``justif[y] notification'' (i.e., potential for risk is very low in
light of the low level of LCPFAC present in the surface coating). EPA
is seeking comment on whether there would be reasonable potential for
exposure under typical conditions of use of the article as contrasted
with laboratory experiments designed to release the LCPFAC under
laboratory conditions.
Alternatively, EPA could establish or use specific criteria to
determine whether or not the ``reasonable potential for exposure''
justifies notification. For example, EPA could receive from importers
information on the level of LCPFAC in the product or in the surface
coating, and determine the level is low enough to not meet the
``reasonable potential for exposure'' notification requirement. EPA
notes also that a person's exposure to LCPFAC could be impacted by
whether or not the article itself is used as a stand-alone product or
incorporated into another product, and as such receiving such
information could also be of help to the Agency. Another consideration
could be that EPA requests information on the method by which the
LCPFAC is incorporated into the surface coating and whether that method
changes the likelihood of release from the article. EPA seeks comment
on the above discussion and on criteria that the Agency could use to
determine whether or not the ``reasonable potential for exposure''
justifies notification. EPA seeks detailed input on these potential
criteria, as well as other suggestions for criteria that could be
implemented to help ensure that the notification is justified.
We invite robust comment on these and other possible thresholds or
criteria that could be implemented by EPA in a final rule.
Finally, EPA notes that diverse importers of articles could be
affected by this rule, and that some may be unfamiliar with the SNUR
process and may not identify at the time of this rulemaking that they
have an ongoing use of a LCPFAC. EPA requests comment on whether or not
the Agency should include a safe harbor provision for importers of
articles that can demonstrate their use was ongoing prior to the
effective date of this rule. EPA requests that commenters discuss the
text of section 5(a)(5) and how the discretion granted therein could be
exercised to allow for a safe harbor provision. EPA also requests
specific language that could be used in structuring such a safe harbor
provision.
H. What should I consider as I prepare my comments for EPA?
When submitting your comments, keep the following items in mind:
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 on-line at
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 is claimed 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 preparing and submitting
your comments, see the commenting tips at http://www2.epa.gov/dockets/commenting-epa-dockets#tips.
II. Chemical Substances Subject to This Proposed Rule
A. What chemicals are covered by this supplemental proposal?
This supplemental proposal would modify the requirements for a
subset of LCPFAC chemical substances at 40 CFR 721.10536 by making the
exemption at 40 CFR 721.45(f) inapplicable for persons who import
LCPFAC chemical substances listed in this unit and PFOA or its salts
(see the second bulleted list of this unit) as part of an article in
which these LCPFAC chemical substances have been applied as part of a
surface coating. The subset of LCPFAC chemical substances also includes
the salts and precursors of these perfluorinated carboxylates. EPA
proposes to make the exemption inapplicable for import of these
articles because there is reasonable potential for exposure to LCPFAC
chemical substances, including PFOA, if these chemical substances are
part of surface coatings on articles imported into the United States.
As proposed in the 2015 SNUR NPRM, the article exemption
[[Page 12483]]
would still apply to LCPFAC chemical substances not listed in this
unit, with the exception of the import of carpets, for which the import
exemption is already inapplicable (78 FR 62443; October 22, 2013) (FRL-
9397-1). The other provision of 40 CFR 721.45(f), respecting processing
a chemical substance as part of an article, remains applicable. These
LCPFAC chemical substances are:
Perfluorooctyl iodide (CAS Registry No. (CASRN) 507-63-1; TSCA
Chemical Inventory Name: Octane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-
heptadecafluoro-8-iodo-)
Tetrahydroperfluoro-1-decanol (CASRN 678-39-7; TSCA Chemical
Inventory Name: 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
heptadecafluoro-)
Perfluoro-1-dodecanol (CASRN 865-86-1; TSCA Chemical Inventory
Name: 1-Dodecanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,12-
heneicosafluoro-)
Perfluorodecyl iodide (CASRN 2043-53-0; TSCA Chemical
Inventory Name: Decane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-
heptadecafluoro-10- iodo-)
1,1,2,2-Tetrahydroperfluorododecyl iodide (CASRN 2043-54-1;
TSCA Chemical Inventory Name: 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-)
Perfluorodecylethyl acrylate (CASRN 17741-60-5; TSCA Chemical
Inventory Name: 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)
1,1,2,2-Tetrahydroperfluorodecyl acrylate (CASRN 27905-45-9;
TSCA Chemical Inventory Name: 2-Propenoic acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl ester)
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-iodotetradecane (CASRN 30046-31-2; TSCA Chemical
Inventory Name: 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-)
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-
Pentacosafluorotetradecan-1-ol (CASRN 39239-77-5; TSCA Chemical
Inventory Name: 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-)
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,16
-Nonacosafluorohexadecan-1-ol (CASRN 60699-51-6; TSCA Chemical
Inventory Name: 1-Hexadecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,16
-nonacosafluoro-)
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-iodohexadecane (CASRN 65510-55-6; TSCA Chemical
Inventory Name: 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-)
Sodium;2-methylpropane-1-sulfonate (CASRN 68187-47-3; TSCA
Chemical Inventory Name: 1-Propanesulfonic acid, 2-methyl-, 2-[[1-oxo-
3-[(.gamma.-.omega.-perfluoro- C4-16-alkyl)thio]propyl]amino] derivs.,
sodium salts)
1,1,2,2-Tetrahydroperfluoroalkyl (C8-C14) alcohol (CASRN
68391-08-2; TSCA Chemical Inventory Name: Alcohols, C8-14,
.gamma.-.omega.-perfluoro)
Thiols, C8-20, gamma-omega-perfluoro, telomers with acrylamide
(CASRN 70969-47-0; TSCA Chemical Inventory Name: 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 (CASRN
125476-71-3; TSCA Chemical Inventory Name: 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) (CASRN 1078712-88-5; TSCA Chemical
Inventory Name: 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-alkyl)thio)acetyl) derivs., inner
salts (CASRN 1078715-61-3; TSCA Chemical Inventory Name: 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 (generic) (CASRN is CBI; EPA Accession
No. 71217; TSCA Chemical Inventory Name: Polyfluoroalkyl betaine
(PROVISIONAL))
Modified fluoroalkyl urethane (generic) (CASRN is CBI; EPA
Accession No. 89419; TSCA Chemical Inventory Name: Modified fluoroalkyl
urethane (PROVISIONAL))
Perfluorinated polyamine (generic) (CASRN is CBI; EPA
Accession No. 274147; TSCA Chemical Inventory Name: Perfluorinated
polyamine (PROVISIONAL))
The term LCPFAC refers to the long-chain category of perfluoroalkyl
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. of the proposed rule (Ref. 1) for further discussion of the
LCPFAC category. In addition to the subset of LCPFAC chemical
substances identified in the list above, PFOA and its salts would be
subject to the proposal. PFOA and its salts are considered LCPFAC
chemical substances. PFOA and examples of PFOA salts with CASRNs and
chemical names are as follows:
Pentadecafluorooctanoyl fluoride (CASRN 335-66-0; TSCA
Chemical Inventory Name: Octanoyl fluoride,
2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-pentadecafluoro-)
Perfluorooctanoic acid (CASRN 335-67-1; TSCA Chemical
Inventory Name: Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro- (PFOA))
Silver perfluorooctanoate (CASRN 335-93-3; TSCA Chemical
Inventory Name: Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro-, silver (+) salt (1:1))
Sodium perfluorooctanoate (CASRN 335-95-5; TSCA Chemical
Inventory Name: Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro-, sodium salt (1:1))
Potassium perfluorooctanoate (CASRN 2395-00-8; TSCA Chemical
Inventory Name: Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro-, potassium salt (1:1))
Ammonium perfluorooctanoate (CASRN 3825-26-1; TSCA Chemical
Inventory Name: Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro-, ammonium salt (1:1) (APFO)
B. What are the uses and production volumes 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. The ammonium
salt of PFOA was manufactured in U.S. for use primarily as an aqueous
dispersion agent in the manufacture of fluoropolymers. Chemical Data
[[Page 12484]]
Reporting (CDR) rule requires manufacturers (including importers) to
report for PFOA if they meet 2,500 pounds production volume threshold
at a single site. The last time PFOA manufacture was reported to EPA as
part of this collection effort was for the 2016 reporting period. PFOA
can also be created unintentionally by the degradation of some
fluorotelomers, which are not manufactured using PFOA but could degrade
to PFOA. Fluorotelomers are used to make polymers that impart soil,
stain, grease, and water resistance to coated articles. Some
fluorotelomer based products are also used as high-performance
surfactants in products where an even flow is essential, such as
paints, coatings, cleaning products, and fire-fighting foams for use on
liquid fuel fires (Ref. 3).
Through the 2010/2015 PFOA Stewardship Program, a voluntary risk
reduction program, eight major manufacturers and processors of LCPFAC
chemical substances committed to voluntarily work toward a phase-out of
LCPFAC chemical substances (Ref. 4). All participating companies have
met the PFOA Stewardship Program goals and have ceased the manufacture
(including import) of the chemical substances listed in Tables 1 and 2
of this unit. As such, the reduced supply of long-chain perfluorinated
chemicals has led industries to transition to replacement chemical
substances for many uses, as noted in both public comments and industry
communication. However, there are still a number of ongoing uses of
these chemical substances by companies not participating in the PFOA
Stewardship Program. EPA became aware of these uses through public
comments identifying several ongoing uses. In the final rule, EPA will
recognize and exclude from the significant new uses any confirmed
ongoing activities for these chemicals. Ongoing uses identified by EPA
are not significant new uses of LCPFAC chemical substances and
therefore would not be subject to this rule and would not require a
significant new use notice submission to the Agency.
The accompanying economic analysis for this supplemental proposed
rule (Ref. 2) details which chemicals listed in Tables 1 and 2 of this
unit were reported under the CDR rule (40 CFR 711) as manufactured
(including imported) for 2015, the final year of the Stewardship
Program (see Exhibits 2-1, 2-2, and 2-3 of the Economic Analysis). The
production volumes have been withheld to protect confidential business
information.
C. What are the potential health effects of LCPFAC chemical substances?
To date, PFOA has LCPFACs have been linked to a number of health
effects, including thyroid disease and impacts on reproductive function
(Refs. 5 and 6). PFOA and its salts, which are considered LCPFAC
chemical substances, have been the primary focus of studies related to
LCPFAC class of chemical substances. PFOA is persistent, widely present
in humans and the environment, has a half-life in humans of 2.3-3.8
years, and can cause adverse effects in laboratory animals, including
cancer and developmental and systemic toxicity (Refs. 3, 7, 8, 9, and
10). Human epidemiology data report associations between PFOA exposure
and high cholesterol, increased liver enzymes, decreased vaccination
response, thyroid disorders, pregnancy-induced hypertension and
preeclampsia, and cancer (testicular and kidney) (Ref. 11).
III. Rationale and Objectives
A. Rationale
This supplemental proposal presents the basis for the reasonable
potential for exposure to LCPFAC chemical substances from this category
of articles for purposes of TSCA section 5(a)(5). LCPFAC chemical
substances have been found in the blood of the general human
population, as well as in wildlife, indicating that exposure to these
chemical substances is widespread (Ref. 3, 12, and 13). Multiple
pathways of exposure, including through drinking water, food, house
dust, and release from treated articles are possible (Ref. 14).
In the absence of a regulation, manufacture or processing for the
significant new uses proposed on January 21, 2015 (Ref. 1), may begin
at any time, without prior notice to EPA. As explained in the January
21, 2015, proposal (Ref. 1), EPA is concerned that commencement of the
manufacture (including import) or processing for any new uses,
including resumption of past uses, of LCPFAC chemical substances could
increase the magnitude and duration of exposure to humans.
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 is not based on an extensive evaluation of the hazard,
exposure, or potential risk associated with that use. Rather, the
existence of a SNUR requires a notice, upon receipt of which EPA would
conduct an assessment. If a person decides to begin importing any of
these chemicals for a significant new use, the notice to EPA allows the
Agency to evaluate the use according to the specific parameters and
circumstances surrounding the conditions of use.
In most cases, LCPFAC chemical substances are not incorporated into
the article and bound to the article matrix but are rather added or
applied as a coating or as part of coating aid. Surface coatings are
subject to mechanical and/or chemical or photolytic stress, which can
lead to degradation of the coating layer, depending on the
circumstances (e.g., depending upon the stressor and the type of
coating matrix). As an unbound, unincorporated component of a surface
coating (Refs. 15 and 16), LCPFAC chemical substances can thereby be
released from the coating as a result of this degradation of the
coating layer. Additionally, because LCPFAC chemical substances used in
this category of articles are coating the surface, if the underlying
substrate of the article is degraded and released, the LCPFAC surface
coating could be released at the same time.
Rather than making the article exemption inapplicable for any
article, as was proposed in the January 21, 2015, proposal (Ref. 1),
this action proposes to make a finding under TSCA section 5(a)(5) and
make the article exemption at 40 CFR 721.45(f) inapplicable for persons
importing the category of articles that contain certain LCPFAC chemical
substances as part of a surface coating for a non-ongoing use. EPA
defines ``articles where certain LCPFAC chemical substances are part of
surface coating on articles'' as the category of articles subject to
this rule, based on the reasonable potential for exposure as shown
through research on LCPFAC chemical substances. This category of
articles is expected to exhibit reasonable potential for exposure to
LCPFAC chemical substances, as elaborated herein. EPA is not making a
finding on the reasonable potential for exposure from articles that do
not contain LCPFAC chemical substances as a surface coating.
i. Reasonable Potential for Exposure of LCPFAC From Surface Coatings
A coating is a material applied in a thin layer to a surface as a
protective, decorative, or functional film. This term often refers to
paints such as lacquers or enamels, but also refers to films applied to
other materials including, but are not limited to, paints, varnishes,
sealants, adhesives, inks, maskants, and temporary protective coatings.
LCPFAC chemical substances have been used in surface coatings for
numerous applications given their hydrophobic and lipophobic
properties. Examples of
[[Page 12485]]
LCPFAC coating applications in articles are stain- and water-repellent
fabrics and nonstick products (e.g., coatings for cookware) (Ref. 3).
The release of LCPFAC chemical substances from coatings on articles
has been well-documented in the scientific literature. LCPFAC chemical
substances can be released continuously over years from treated
jackets, furniture, and carpets into the air due to volatilization
(Refs. 17, 18, and 19) and due to degradation of commercial LCPFAC
coatings by simple abiotic reaction with water (Ref. 20). Stone and
tile sealants have been shown to contain extractable amounts of LCPFAC
chemical substances and, for homes without carpeting, could be an
indoor source of these chemical substances (Ref. 21).
Given the reasonable potential for exposure to LCPFAC chemical
substances from articles that have LCPFAC chemical substances as part
of a surface coating, EPA is proposing to require notification for the
import of articles that have LCPFAC chemical substances as part of a
surface coating. As noted in Section 1F, EPA is also seeking robust
comment on implementing a de minimis threshold, an alternative
threshold, or other criteria to assist in determining whether the
reasonable potential for exposure justifies notification to EPA. EPA is
also seeking comment on a safe harbor provision.
Articles that could potentially have LCPFAC chemical substances as
part of a surface coating include, but are not limited to: Furniture,
medical garments, safety equipment, outdoor apparel or equipment,
automobile components, aerospace components, electronics, heavy
machinery, and household appliances. EPA cites these studies (Refs. 17,
18, 19, 20, and 21) to support the Agency's conclusion that there is
reasonable potential for exposure from the category of articles that
contain certain LCPFAC chemical substances as part of a surface
coating.
ii. Proposed Finding
Based on these considerations, EPA is proposing to make the TSCA
section 5(a)(5) finding and make inapplicable the exemption at 40 CFR
721.45(f) for persons who import any of a defined set of LCPFAC
chemical substances as part of an article where LCPFAC chemical
substances have been applied as part of a surface coating for a non-
ongoing use. The defined subset are the chemical substances phased out
through the 2010/2015 PFOA Stewardship Program, shown in Table 1 and
Table 2 of Unit II.
The article exemption at 40 CFR 721.45(f) is based on an assumption
that people and the environment will generally not be exposed to
chemical substances in articles (Ref. 22). However, when added to the
surface coating of an article, LCPFAC can be released over time with
use (Refs. 3 and 20). Studies on the degradation of fluorotelomer-based
polymers show that these polymers are subject to hydrolysis, photolysis
and biodegradation, with half-lives of a few days to hundreds of years
(Ref. 23). In addition, research by EPA on degradation of
fluorotelomers and fluoropolymers has shown that some urethanes and
acrylates biodegrade; however, half-lives and kinetics are not yet
well-defined (Ref. 16). These studies have shown that the
perfluorinated portion of some polymers is released as the polymer is
degraded by microbial or abiotic processes to form telomer alcohols or
other intermediates and that they eventually form LCPFAC. Based on this
understanding, upon receipt of a SNUN, EPA intends to evaluate the
potential risk of exposure to human health and the environment for any
intended significant new use of LCPFAC chemical substances (including
as part of a surface coating of an article).
Given that the release of LCPFAC chemical substances from surface
coatings on articles has been shown to occur and that these releases
can be expected to result in exposure to the users of articles, EPA has
reason to anticipate that importing articles that have certain LCPFAC
chemical substances as part of a surface coating would create the
potential for exposure to these LCPFAC chemical substances, and that
EPA should have an opportunity to review the intended use before such
use could occur. Therefore, EPA affirmatively finds under TSCA section
5(a)(5) that notification for import is justified by the reasonable
potential for exposure to certain LCPFAC chemical substances when part
of surface coatings for the articles identified in this SNUR. Existence
of the SNUR triggers the submission of a SNUN, thereby allowing EPA to
evaluate potential uses (before those uses would begin) whether in the
form of an article, or not, for any hazards, exposures and risks that
might exist.
A person who imports any of the chemical substances identified in
this supplemental proposed SNUR for a significant new use as part of a
surface coating on an article would be subject to the significant new
use notification requirements. No person would be able to begin
importing, as part of a surface coating for an article, any of the
LCPFAC chemical substances identified in this supplemental proposed
SNUR, for a significant new use without first submitting a SNUN to EPA.
B. Objectives
Based on the considerations in Unit III.A., EPA wants to achieve
the following objectives with regard to the significant new uses of
LCPFAC chemical substances that are designated in the January 21, 2015,
proposal (Ref. 1), including the articles identified in this
supplemental proposal:
1. EPA would receive notice of any person's intent to import the
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 importing the
chemical substances for the described significant new use.
3. EPA would be able to either determine that the significant new
use is not likely to present an unreasonable risk, or to take necessary
regulatory action associated with any other determination, before the
described significant new use of the chemical substance occurs.
IV. Economic Analysis
A. SNUNs
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential importers of the chemical
substance included in this supplemental proposal in surface coatings of
articles (Ref. 2). In the event that a SNUN is submitted, average costs
are estimated at approximately $23,000 per SNUN submission for large
business submitters and about $10,000 for small business submitters.
These estimates include the cost to prepare and submit the SNUN
(averaging about $7,300), and the payment of a user fee. Businesses
that submit a SNUN would be subject to either a $16,000 user fee
required by 40 CFR 700.45(c)(2)(ii), or, if they are a small business,
a reduced user fee of $2,800 (40 CFR 700.45(c)(1)(ii)). Businesses that
submit a SNUN are also estimated to incur average costs of $63 for rule
familiarization. First time submitters will incur an average cost of
$123 for CDX registration and associated activities. Companies
importing articles containing LCPFAC chemical substances as part of a
surface coating will incur an average cost of $79 for notifying their
customers of SNUR regulatory activities. EPA's complete economic
analysis is available in the public docket for this rule (Ref. 2).
In making inapplicable the exemption relating to persons who import
certain
[[Page 12486]]
chemical substances as part of the surface coating of an article, this
action may affect firms that plan to import or process types of
articles that may contain the subject chemical substance in a surface
coating. This is because while some firms have an understanding of the
contents of the articles they import or process other firms do not. EPA
acknowledges that importers and processors of articles may have varying
levels of knowledge about the chemical content of the articles that
they import or process. These parties may need to become familiar with
the requirements of the 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
for import or processing. 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 or processes. Cost ranges are presented in
Understanding the Costs Associated with Eliminating Exemptions for
Articles in SNURs (Ref. 24). Based on available information, EPA
believes that article importers or processors 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 or process, 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 for the significant
new uses identified in Units II. and III., and the resources it has
available. Example activities and their costs are provided in the
accompanying Economic Analysis of this supplemental proposal (Ref. 2).
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 substance that is the subject of a SNUR, a one-
time notice to EPA 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 is
exported).
V. Scientific Standards, Evidence, and Available Information
EPA has used scientific information, technical procedures,
measures, methods, protocols, methodologies, and models consistent with
the best available science, as applicable. These information sources
supply information relevant to whether a particular use would be a
significant new use, based on relevant factors including those listed
under TSCA section 5(a)(2). Consistent with EPA's past practice for
issuing SNURs under TSCA section 5(a)(2), EPA's decision to promulgate
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; as such, the January 2015 proposed rule (Ref. 1) and this
supplemental proposal are not based on an evaluation of expected risks.
The clarity and completeness of the data, assumptions, methods,
quality assurance, and analyses employed in EPA's decision are
documented, as applicable and to the extent necessary for purposes of
the January 2015 proposed rule and this supplemental proposal, in Unit
II. and in the references cited throughout the two preambles.
Considering the extent to which the various information, procedures,
measures, methods, protocols, methodologies or models used in EPA's
decision have been subject to independent verification or peer review,
EPA believes that their use is appropriate in this rule. EPA
recognizes, based on the available information, that there is
variability and uncertainty in whether any particular significant new
use would actually present an unreasonable risk. For precisely this
reason, EPA is proposing to require notice and review for these uses at
such time as they are known more definitely.
VI. 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 included 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 Perfluoroalkyl Carboxylate and Perfluoroalkyl
Sulfonate Chemical Substances; Significant New Use Rule. Proposed
Rule. Federal Register. 80 FR 2885, January 21, 2015 (FRL-9915-63).
2. EPA. Economic Analysis of the Supplemental Proposal to the
Significant New Use Rule for Perfluoroalkyl Sulfonates and Long-
Chain Perfluoroalkyl Carboxylate Chemical Substances. January 23,
2020.
3. EPA. Long-Chain Perfluorinated Chemicals Action Plan. December
30, 2009. Accessed at: https://www.epa.gov/sites/production/files/2016-01/documents/pfcs_action_plan1230_09.pdf.
4. EPA. Risk Management for Per- and Polyfluoroalkyl Substances
(PFASs) under TSCA. Accessed at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-and-polyfluoroalkyl-substances-pfass.
5. Melzer, David, et al. ``Association between serum
perfluorooctanoic acid (PFOA) and thyroid disease in the US National
Health and Nutrition Examination Survey.'' Environmental health
perspectives 118.5 (2010): 686-692.
6. Knox, Sarah S., et al. ``Implications of early menopause in women
exposed to perfluorocarbons.'' The Journal of Clinical Endocrinology
& Metabolism 96.6 (2011): 1747-1753.
7. Butt, Craig M., et al. ``Levels and trends of poly-and
perfluorinated compounds in the arctic environment.'' Science of the
Total Environment 408.15 (2010): 2936-2965.
8. Houde, Magali, et al. ``Biological monitoring of polyfluoroalkyl
substances: a review.'' Environmental Science & Technology 40.11
(2006): 3463-3473.
9. Calafat, Antonia M., et al. ``Polyfluoroalkyl chemicals in the US
population: data from the National Health and Nutrition Examination
Survey (NHANES) 2003-2004 and comparisons with NHANES 1999-2000.''
Environmental Health Perspectives 115.11 (2007): 1596.
10. Lau, Christopher, et al. ``Perfluoroalkyl acids: a review of
monitoring and toxicological findings.'' Toxicological Sciences 99.2
(2007): 366-394.
11. EPA. Health Effects Support Document for Perfluorooctanoic Acid
(PFOA). EPA 822-R-16-003. May 2016.
12. EPA. Perfluoroalkyl Sulfonates; Significant New Use Rule; Final
Rule. Federal Register. 67 FR 11008, March 11, 2002 (FRL-6823-6).
13. 3M Company. The Science of Organic Fluorochemistry. St. Paul,
Minnesota, February 5, 1999.
14. Strynar, Mark J., and Andrew B. Lindstrom. ``Perfluorinated
compounds in house dust from Ohio and North Carolina, USA.''
Environmental Science & Technology 42.10 (2008): 3751-3756.
15. Bohnet, Matthias. Ulmann's Encyclopedia of Industrial Chemistry.
Wiley-Vch, 2003.
16. Plastics Industry Association. Guide to the Safe Handling of
Fluoropolymer Resins. Fifth Addition. 2018.
17. Knepper, Thomas P., et al. ``Understanding the exposure pathways
[[Page 12487]]
of per-and polyfluoralkyl substances (PFASs) via use of PFASs-
containing products-risk estimation for man and environment.'' Texte
47 (2014): 2014.
18. Gremmel, Christoph, et al. ``Systematic determination of
perfluoroalkyl and polyfluoroalkyl substances (PFASs) in outdoor
jackets.'' Chemosphere 160 (2016): 173-180.
19. Liu, Xiaoyu, et al. ``Determination of fluorotelomer alcohols in
selected consumer products and preliminary investigation of their
fate in the indoor environment.'' Chemosphere 129 (2015): 81-86.
20. Washington, J.W., T.M. Jenkins. 2015. Abiotic hydrolysis of
fluorotelomer polymers as a source of perfluorocarboxylates at the
global scale. Environmental Science & Technology. 49. 14129-14135.
21. Guo, Zhishi, et al. ``Perfluorocarboxylic acid content in 116
articles of commerce.'' Research Triangle Park, NC: US Environmental
Protection Agency (2009).
22. EPA. Significant New Uses of Chemical Substances; Certain
Chemicals; Final Rule. Federal Register. 49 FR 35014, September 5,
1984 (FRL-2541-8).
23. Washington, John W., et al. ``Decades-scale degradation of
commercial, side-chain, fluorotelomer-based polymers in soils and
water.'' Environmental science & technology 49.2 (2015): 915-923.
24. U.S. EPA. Understanding the Costs Associated with Eliminating
Exemptions for Articles in SNURs. May 1, 2013.
VII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
The Office of Management and Budget (OMB) designated this to be a
significant regulatory action and it was submitted to OMB for review
under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563
(76 FR 3821, January 21, 2011). Any changes made in response to OMB
recommendations have been documented in the docket for this action as
required by section 6(a)(3)(E) of Executive Order 12866.
EPA prepared an economic analysis of the potential costs and
benefits associated with this action. A copy of the economic analysis,
entitled ``Economic Analysis of the Supplemental Proposal to the
Significant New Use Rule for Perfluoroalkyl Sulfonates and Long-Chain
Perfluoroalkyl Carboxylate Chemical Substances'' (Ref. 2), is available
in the docket and is briefly summarized in Unit IV.
B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
This action is expected to be subject to the requirements for
regulatory actions specified in Executive Order 13771 (82 FR 9339,
February 3, 2017). EPA prepared an analysis of the estimated costs and
benefits associated with this action (Ref. 2), which is available in
the docket and is summarized in Unit I.E.
C. Paperwork Reduction Act (PRA)
This action does not impose any new information collection burden
under the 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 under OMB control number
2070-0038 (EPA ICR No. 1188); and the information collection activities
associated with export notifications are already approved 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 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.
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 the 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, as applicable.
D. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I
certify that promulgation of this SNUR would not have a significant
economic impact on a substantial number of small entities. The
rationale supporting this conclusion is as follows.
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.'' By definition of the word ``new'' and based on
all information currently available to EPA, it appears that no small or
large entities presently engage in such activities. Since this SNUR
will require a person who intends to engage in such activity in the
future to first notify EPA by submitting a SNUN, no economic impact
will 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 conduct
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 2005-2010, only three submitters self-
identified as small in their SNUN submission (Ref. 2). Based on this,
EPA believes that few SNUN submissions will occur as a result of the
rule. EPA believes the cost of submitting a SNUN, $10,000 for small
business submitters, is relatively small compared to the cost of
developing and marketing a chemical new to a firm or marketing a new
use of the chemical and that the requirement to submit a SNUN generally
does not have a significant economic impact.
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. In a SNUR that
published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4),
the Agency presented its general determination that proposed and final
SNURs are not expected to have a significant economic impact on a
substantial number of small entities.
E. 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
rulemaking. As such, the requirements of sections 202, 203, 204, or 205
of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.
F. Executive Order 13132: Federalism
This action will not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have 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.
[[Page 12488]]
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have any effect 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.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this action does not address environmental
health or safety risks, and EPA interprets Executive Order 13045 as
applying only to those regulatory actions that concern environmental
health or safety risks that EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a significant energy action as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have any effect on energy supply, distribution, or use.
J. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve any technical standards and is
therefore not subject to considerations under section 12(d) of NTTAA,
15 U.S.C.272 note.
K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action will not have disproportionately high and adverse human
health or environmental effects on minority or low-income populations
as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
This action does 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: February 20, 2020.
Andrew R. Wheeler,
Administrator.
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. 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 in this paragraph,
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.
Table 1 to Paragraph (b)--LCPFAC Chemical Substances Subject to Reporting After December 31, 2015
----------------------------------------------------------------------------------------------------------------
EPA
Chemical name CAS registry No. accession TSCA chemical inventory name
(CASRN) No.
----------------------------------------------------------------------------------------------------------------
Perfluorooctyl iodide................. 507-63-1................ N/A Octane,
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-
heptadecafluoro-8-iodo-.
Tetrahydroperfluoro-1-decanol......... 678-39-7................ N/A 1-Decanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,
10-heptadecafluoro-.
Perfluoro-1-dodecanol................. 865-86-1................ N/A 1-Dodecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,
11,11,12,12,12-heneicosafluoro-.
Perfluorodecyl iodide................. 2043-53-0............... N/A Decane,
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-
heptadecafluoro-10-iodo-.
1,1,2,2-Tetrahydroperfluorododecyl 2043-54-1............... N/A Dodecane,
iodide. 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,
9,9,10 ,10-heneicosafluoro-12-iodo-
.
Perfluorodecylethyl acrylate.......... 17741-60-5.............. N/A 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.
1,1,2,2-Tetrahydroperfluorodecyl 27905-45-9.............. N/A 2-Propenoic acid,
acrylate. 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,
10-heptadecafluorodecyl ester.
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9, 30046-31-2.............. N/A Tetradecane,
10,10,11,11,12,12-Pentacosafluoro-14- 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,
iodotetradecane. 9,9,10,10,11,11,12,12-
pentacosafluoro-14-iodo-.
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,1 39239-77-5.............. N/A 1-Tetradecanol,
1,12,12,13,13,14,14,14- 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,
Pentacosafluorotetradecan-1-ol. 11,11,12,12,13,13,14,14,14-
pentacosafluoro-.
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,1 60699-51-6.............. N/A 1-Hexadecanol,
1,12,12,13,13,14,14,15,15,16,16,16- 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,
Nonacosafluorohexadecan-1-ol. 11,11,12,12,13,13,14,14,15,15,16,1
6,16-nonacosafluoro-.
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9, 65510-55-6.............. N/A Hexadecane,
10,10,11,11,12,12,13,13,14,14- 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,
Nonacosafluoro-16-iodohexadecane. 9,9,10,10,11,11,12,12,13,13,14,14-
nonacosafluoro-16-iodo-.
Sodium;2-methylpropane-1-sulfonate.... 68187-47-3.............. N/A 1-Propanesulfonic acid, 2-methyl-,
2-[[1-oxo-3-[(.gamma.-.omega.-
perfluoro- C4-16-
alkyl)thio]propyl]amino] derivs.,
sodium salts.
1,1,2,2-Tetrahydroperfluoroalkyl (C8- 68391-08-2.............. N/A Alcohols, C8-14, .gamma.-.omega.-
C14) alcohol. perfluoro.
Thiols, C8-20, gamma-omega-perfluoro, 70969-47-0.............. N/A Thiols, C8-20, .gamma.-.omega.-
telomers with acrylamide. perfluoro, telomers with
acrylamide.
Silicic acid (H4SiO4), sodium salt 125476-71-3............. N/A Silicic acid (H4SiO4), sodium salt
(1:2), reaction products with (1:2), reaction products with
chlorotrimethylsilane and chlorotrimethylsilane and
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10- 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,
heptadecafluoro-1-decanol. 10-heptadecafluoro-1-decanol.
Thiols, C4-20, gamma-omega-perfluoro, 1078712-88-5............ N/A Thiols, C4-20, .gamma.-.omega.-
telomers with acrylamide and acrylic perfluoro, telomers with
acid, sodium salts). acrylamide and acrylic acid,
sodium salts.
1-Propanaminium, 3-amino-N- 1078715-61-3............ N/A 1-Propanaminium, 3-amino-N-
(carboxymethyl)-N,N-dimethyl-, N-(2- (carboxymethyl)-N,N-dimethyl-, N-
((gamma-omega-perfluoro-C4-20- [2-[(.gamma.-.omega.-perfluoro-C4-
alkyl)thio)acetyl) derivs., inner 20-a lkyl)thio]acetyl] derivs.,
salts. inner salts.
Polyfluoroalkyl betaine (generic)..... CBI..................... 71217 Polyfluoroalkyl betaine
(PROVISIONAL).
[[Page 12489]]
Modified fluoroalkyl urethane CBI..................... 89419 Modified fluoroalkyl urethane
(generic). (PROVISIONAL).
Perfluorinated polyamine (generic).... CBI..................... 274147 Perfluorinated polyamine
(PROVISIONAL)
----------------------------------------------------------------------------------------------------------------
(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 to Paragraph (b)--PFOA and Examples of Its Salts
------------------------------------------------------------------------
CAS registry
Chemical name No. TSCA chemical inventory
(CASRN) name
------------------------------------------------------------------------
Pentadecafluorooctanoyl fluoride 335-66-0 Octanoyl fluoride,
2,2,3,3,4,4,5,5,6,6,7,7
,8,8,8-pentadecafluoro-
.
Perfluorooctanoic acid.......... 335-67-1 Octanoic acid,
2,2,3,3,4,4,5,5,6,6,7,7
,8,8,8-pentadecafluoro-
(PFOA).
Silver perfluorooctanoate....... 335-93-3 Octanoic acid,
2,2,3,3,4,4,5,5,6,6,7,7
,8,8,8-pentadecafluoro-
, silver (+) salt
(1:1).
Sodium perfluorooctanoate....... 335-95-5 Octanoic acid,
2,2,3,3,4,4,5,5,6,6,7,7
,8,8,8-pentadecafluoro-
, sodium salt (1:1).
Potassium perfluorooctanoate.... 2395-00-8 Octanoic acid,
2,2,3,3,4,4,5,5,6,6,7,7
,8,8,8-pentadecafluoro-
, potassium salt (1:1).
Ammonium perfluorooctanoate..... 3825-26-1 Octanoic acid,
2,2,3,3,4,4,5,5,6,6,7,7
,8,8,8-pentadecafluoro-
, ammonium salt (1:1)
(APFO).
------------------------------------------------------------------------
(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. (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 when they are part of a surface coating of an article. 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 a
surface coating on an article 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]
[FR Doc. 2020-03865 Filed 3-2-20; 8:45 am]
BILLING CODE 6560-50-P