Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule, 45109-45126 [2020-13738]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 85, Number 144 (Monday, July 27, 2020)]
[Rules and Regulations]
[Pages 45109-45126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13738]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2013-0225; FRL-10010-44]
RIN 2070-AJ99


Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl 
Sulfonate Chemical Substances; Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Under the Toxic Substances Control Act (TSCA), the 
Environmental Protection Agency (EPA) is finalizing amendments to the 
significant new use rule (SNUR) for long-chain perfluoroalkyl 
carboxylate (LCPFAC) chemical substances that were proposed on January 
21, 2015; an amendment to a SNUR for perfluoroalkyl sulfonate chemical 
substances that was proposed on January 21, 2015; and an amendment to 
make inapplicable the exemption for persons who import a subset of 
LCPFAC chemical substances as part of surface coatings on articles, 
which was proposed on March 3, 2020. This final rule requires persons 
to notify EPA at least 90 days before commencing the manufacture 
(including import) or processing of these chemical substances for the 
significant new uses described in this notice. The required significant 
new use notification initiates EPA's evaluation of the conditions of 
use associated with the significant new use. Manufacturing (including 
import) or processing for the significant new use are 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. As with any SNUR, this 
final rule excludes ongoing uses. Ongoing uses cannot be subject to a 
SNUR.

DATES: This final rule is effective September 25, 2020.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2013-0225, is available at 
https://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW, Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public

[[Page 45110]]

Reading Room is (202) 566-1744, and the telephone number for the OPPT 
Docket is (202) 566-0280. Please review the visitor instructions and 
additional information about the docket available at https://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 in the class of long-chain perfluoroalkyl 
carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances. 
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:
     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).
     Manufacturers of computer and other electronic products, 
appliances, and components (NAICS codes 324 and 335).
     Manufacturers of surgical and medical instruments (NAICS 
339112).
     Merchant wholesalers (NAICS codes 423 and 424).
     Stores and retailers (NAICS codes 442, 442, 444, 448, 451, 
454).
     Providers of other support services (NAICS code 561990).
    Other types of entities not listed in this unit could also be 
affected. The NAICS codes have been provided to assist you and others 
in determining whether this action might apply to certain entities.
    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 final 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). TSCA 
section 5(a)(2) (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 the following factors:
     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 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)(B)(i) 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)(A)(ii) (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. 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), EPA proposed a SNUR for Long-Chain Perfluoroalkyl Carboxylate and 
Perfluoroalkyl Sulfonate Chemical Substances (Ref. 1). In the Federal 
Register of March 3, 2020 (85 FR 12479) (FRL-10003-21) (Ref. 2), EPA 
supplemented the 2015 proposed SNUR to be responsive to the article 
consideration provision at section 5(a)(5), added with the passage of 
the Frank R. Lautenberg Chemical Safety for the 21st Century Act 
(Lautenberg Act), which states that articles can be subject to 
notification requirements as a significant new use provided that EPA 
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.

[[Page 45111]]

    EPA's response to public comments received on both the 2015 
proposed rule and the 2020 supplemental proposed rule are provided in a 
Response to Comments document that is available in the docket and 
summarized in Unit XII. (Ref. 3). Please consult the Federal Register 
documents of January 21, 2015 (Ref. 1) and March 3, 2020 (Ref. 2) for 
further background information for this final rule.
    This final SNUR will require persons to notify EPA at least 90 days 
before commencing:
    1. The manufacturing (including importing) or processing of a 
subset of LCPFAC chemical substances for any use that was not ongoing 
after December 31, 2015;
    2. The manufacturing (including importing) or processing of all 
other LCPFAC chemicals substances for which there were no ongoing uses 
as of January 21, 2015 (the date of the original 2015 proposal);
    3. The import of a subset of LCPFAC chemicals as part of a surface 
coating on articles; and
    4. The import of perfluoroalkyl sulfonate chemical substances as 
part of carpets.
    This final SNUR will preclude the commencement of such 
manufacturing and processing 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.
    In the Federal Register of April 24, 1990 (55 FR 17376; FRL-3658-
5), EPA 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. 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 would be 
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. This rule was published 
on January 21, 2015 and contains two significant new use dates. The 
first significant new use date is the date that the 2015 proposed rule 
published and applies to: The manufacturing or processing of all LCPFAC 
chemicals substances, other than those listed in the list of LCPFAC 
chemical substances in Unit II.; the import of articles containing a 
subset of LCPFAC chemical substances as part of a surface coating; and 
the import of perfluoroalkyl sulfonate chemical substances as part of 
carpets. The second significant new use date is December 31, 2015, for 
the manufacturing or processing of a subset of LCPFAC chemical 
substances, those listed in the list of LCPFAC chemical substances in 
Unit II. for any use. The chemical substances listed in the list of 
LCPFAC chemical substances in Unit II. correspond to the chemical 
substances that the principal manufacturers and processors of LCPFAC 
chemical substances participating in the 2010/2015 PFOA Stewardship 
Program agreed to phaseout by the end of 2015. Ongoing uses are 
described in the Response to Comment for this rule (Unit XII. and Ref. 
3) and are reflected in updates to the regulatory text.
    In the supplement to the proposed rule (Ref. 2), EPA requested 
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. Additionally, EPA requested 
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 appreciates the 
comments received. In this final rule, EPA is not finalizing a de 
minimis threshold for determining ``reasonable potential for exposure'' 
or a safe harbor provision. EPA will, however, continue to engage with 
interested stakeholders on these two issues. A further discussion of 
the comments received relating to a de minimis threshold and a safe 
harbor provision are included in the Response to Comment for this rule 
(Unit XII. and Ref. 3).

D. Why is the Agency taking this action?

    These SNUR amendments are necessary to ensure that EPA receives 
timely advance notice of any future manufacturing (including importing) 
and processing of LCPFAC and perfluoroalkyl sulfonate chemical 
substances for new uses that may produce changes in human and 
environmental exposures. Additionally, section 7352 of the National 
Defense Authorization Act of 2020 mandates that EPA take final action 
on the 2015 proposal no later than June 22, 2020.
    The rationale and objectives for this rule 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 
final rule. This Economic Analysis (Ref. 4), 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 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. 4), EPA provides 
example steps (and their respective costs) that an importer 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. EPA is unable to predict, however, what, if any, particular 
steps an importer might take; thus, potential total costs were not 
estimated. Importers may require suppliers to provide certificates of 
testing analysis of the products or perform their own laboratory 
testing of certain articles. An estimate of article testing cost is 
provided in Exhibit 3-7 of the Economic Analysis. While testing costs 
will vary depending on the specific chemical being tested for, the 
complexity of the article and sample preparation required, and the 
exact fees of the laboratory chosen for the analysis, an average of 
$150 per article tested is given in the Exhibit.

II. Chemical Substances Subject to This Rule

    This final SNUR modifies the requirements for a subset of LCPFAC 
chemical substances in the existing SNUR at 40 CFR 721.10536 by:
    1. Designating manufacturing (including importing) or processing of 
LCPFAC chemical substances listed in the list of LCPFAC chemical 
substances in this unit for any use that was no longer ongoing after 
December 31, 2015, as a significant new use; and
    2. Designating manufacturing (including importing) or processing of 
perfluorooctanoic acid (PFOA) or its salts, which are considered LCPFAC 
chemical substances, and all other LCPFAC chemical substances for any 
use not ongoing as of January 21, 2015, the date on which the proposed 
rule was published, as a significant new use.
    For this final SNUR, EPA is also making the exemption at 40 CFR

[[Page 45112]]

721.45(f) inapplicable for persons who import LCPFAC chemical 
substances listed in the list of LCPFAC chemical substances in this 
unit and PFOA or its salts (see examples in this unit) as part of a 
surface coating on articles because there is reasonable potential for 
exposure to LCPFAC chemical substances, including PFOA, if these 
chemical substances are incorporated as surface coatings in articles 
and then imported. As was originally proposed in 2015, the article 
exemption still applies to LCPFAC chemical substances not listed in 
this unit or that are not PFOA or its salts, 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 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. of the 2015 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 are subject 
to the final rule. 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).
    EPA is also amending the existing SNUR at 40 CFR 721.9582 for 
perfluoroalkyl sulfonate chemical substances to make the exemption at 
40

[[Page 45113]]

CFR 721.45(f) inapplicable for persons who import perfluoroalkyl 
sulfonate chemical substances as part of carpets, which is being 
finalized as proposed. The perfluoroalkyl sulfonate chemical substances 
for which EPA is modifying an existing SNUR are currently listed in 40 
CFR 721.9582(a)(1). In this rule, which is consistent with the proposal 
and 40 CFR 721.9582, the term perfluoroalkyl sulfonates refers to a 
category of perfluorinated sulfonate chemical substances of any chain 
length. In the 2015 proposed rule, as was past practice, perfluoroalkyl 
sulfonates chemical substances were referred to as ``PFAS'' chemical 
substances. EPA, however, recognizes that the acronym PFAS is now used 
for ``perfluoroalkyl and polyfluoroalkyl substances.'' Moving forward, 
EPA will use PFAS as an acronym for perfluoroalkyl and polyfluoroalkyl 
substances.

III. Rationale and Objectives

A. Rationale

1. Known Exposures to LCPFAC and Perfluoroalkyl Sulfonate Substances
    LCPFAC and perfluoroalkyl sulfonate 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 (Refs. 5, 6, and 7). PFOA and its salts, which are 
considered LCPFAC chemical substances, have been a primary focus of 
studies related to the 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. 5, 8, 9, 10, and 11). 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. 12). 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 more toxic and be present at 
higher concentrations than PFOA (Refs. 13, 14, 15, 16, and 17). 
Multiple pathways of exposure, including through drinking water, food, 
house dust, and release from treated articles, are possible (Ref. 18).
    Perfluoroalkyl sulfonate chemical substances degrade ultimately to 
perfluoroalkylsulfonic acid (PFASA), which can exist in the anionic 
form under certain environmental conditions (Ref. 15). PFASA is highly 
persistent in the environment and has a tendency to bioaccumulate (Ref. 
15). While most studies of perfluoroalkyl sulfonate chemical substances 
to date have focused primarily on perfluorooctane sulfonate (PFOS), 
structure-activity relationship analysis indicates that the results of 
those studies are applicable to the entire category. Available test 
data have raised concerns about their potential developmental, 
reproductive, and systemic toxicity (Refs. 5, 6, 13, and 19).
    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 or processing for any new uses, including resumption of 
past uses, of LCPFAC and perfluoroalkyl sulfonate chemical substances 
could increase the magnitude and duration of exposure to humans and the 
environment.
    The manufacture of LCPFAC chemical substances listed in Unit II. 
was discontinued after December 31, 2015, as committed by the principal 
manufacturers and processors of LCPFAC chemical substances 
participating in the 2010/2015 PFOA Stewardship Program. Given that 
these chemical substances have been discontinued, 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 have ceased (Ref. 20). At this time, 
EPA is aware, and has provided an exemption for, the processing of 
select chemical substances listed in Unit II. that continues from the 
use of existing stocks for specific uses. The processing of existing 
stocks of these LCPFAC chemical substances is expected to decline over 
time as stocks of these chemicals are depleted. Similarly, EPA also 
expects ongoing uses of other LCPFAC chemicals substances to decline 
because the manufacture and processing for those uses have declined or 
ceased, as indicated by industry communication, market research, 
information submitted to EPA under the Chemical Data Reporting (CDR) 
rule, and comments received related to the proposed rule (Ref. 1) and 
supplement to the proposed rule (Ref. 2). In addition, EPA expects the 
presence of perfluoroalkyl sulfonate chemical substances to decline in 
humans and the environment because perfluoroalkyl sulfonates are no 
longer imported as part of carpets. EPA is concerned that the 
manufacturing or processing of these chemical substances for 
significant new uses could be reinitiated in the future. If 
reinitiated, EPA believes that such use could significantly increase 
the magnitude and duration of exposure to humans and the environment to 
these chemical substances.
2. Identification of Significant New Uses
    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 use 
of a chemical substance is not based on an extensive evaluation of the 
hazard, exposure, or potential risk associated with that use. Rather, 
EPA's determination that a use constitutes a significant new use 
requires a notice, upon receipt of which EPA would conduct an 
assessment. If a person decides to begin manufacturing or processing 
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.
3. Basis for Lifting the Article Exemption
    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, which states 
that EPA ``may require notification under this section for the import 
or processing of a chemical substance as part of an article or category 
of articles'' if EPA affirmatively finds in a rule under section 
5(a)(2) that the reasonable potential for exposure to the chemical 
substance through the article or category of articles justifies 
notification. In the 2015 proposal (Ref. 1), 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. After 
careful consideration, and in order to align the 2015 proposed rule 
with the new requirements under TSCA, EPA issued a supplemental 
proposal to require submission of a significant new use notice for the 
import of a subset of LCPFAC chemical substances ``as part of a surface 
coating on articles'' as opposed to ``all articles.'' The supplemental 
proposal better defined the articles subject to the rule by defining 
the subject articles by the category: ``imported articles where certain

[[Page 45114]]

LCPFAC chemical substances are part of a surface coating on the 
articles.'' While the 2020 supplemental and the 2015 proposed SNUR 
differ in language, EPA believes that the difference in impact will be 
minimal. LCPFAC chemical substances can be applied to articles as a 
surface coating. By lifting the articles exemption for articles that 
contain certain LCPFAC chemical substances as part of a surface 
coating, EPA believes that it has captured the majority of article 
applications of these chemical substances. Other than instances where 
LCPFAC chemicals may be used to manufacture fluoropolymer membranes, 
EPA is unaware of any other uses of LCPFAC chemical substances in 
articles other than as a surface coating. EPA may propose future SNURs 
for the import of other articles containing LCPFAC chemical substances 
as appropriate.
    Products such as paints and coatings, lubricants, and fire-fighting 
foam are not articles. As defined at 40 CFR 704.3, article means a 
manufactured item (1) which is formed to a specific shape or design 
during manufacture, (2) which has end use function(s) dependent in 
whole or in part upon its shape or design during end use, and (3) which 
has either no change of chemical composition during its end use or only 
those changes of composition which have no commercial purpose separate 
from that of the article, and that result from a chemical reaction that 
occurs upon end use of other chemical substances, mixtures, or 
articles; except that fluids and particles are not considered articles 
regardless of shape or design. Examples of articles that could contain 
LCPFAC chemical substances as part of a surface coating include, but 
are not limited to, apparel, outdoor equipment, automotive parts, 
carpets, furniture, and electronic components.
    As detailed in the March 3, 2020 supplemental proposal (Ref. 2), 
given that the release of LCPFAC chemical substances from surface 
coatings on articles has been shown to occur and that these releases 
can reasonably be expected to result in exposure to the users of 
articles and the general public (Refs. 21, 22, 23, 24, and 25), EPA has 
reason to anticipate that importing articles that have certain LCPFAC 
chemical substances as part of a surface coating would create a 
reasonable potential for exposure to these LCPFAC chemical substances, 
and that EPA should have an opportunity to review the use before such 
use could occur. Therefore, in light of the evidence before EPA 
(including the studies referenced below), 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 on articles. If a person wants to 
recommence a significant new use, existence of the SNUR ensures the 
submission of a SNUN, thereby allowing EPA to evaluate potential uses 
(before those uses would begin) for any hazards, exposures and risks 
that might exist.
    During the public comment period for the supplemental proposal 
(Ref. 2), several commenters questioned if EPA had adequately shown the 
reasonable potential for exposure from articles containing LCPFAC 
chemical substances as part of a surface coating or the risks 
associated with such potential exposure. One commenter asked that EPA 
provide linking data between presence of LCPFAC chemical substances in 
the general population and the release of LCPFAC chemical substances 
from coatings. EPA believes that the reasonable potential for exposure 
has been addressed through the studies cited in both this final rule 
and the supplement to the proposed rule (Refs. 2, 5, 23, 25, and 26). 
EPA has provided support that there is a reasonable potential for 
exposure through the citation of peer-reviewed literature, which 
documents that LCPFAC chemical substances either have the reasonable 
potential to migrate from articles or that LCPFAC chemical substances 
do migrate from articles. In order to require notification for the 
import or processing of an article under TSCA section 5, it is not 
necessary to definitively show or illustrate the mechanisms by which 
exposure to a chemical substance through an article may occur. Since 
the use designated as a significant new use does not currently exist, 
EPA defers a detailed consideration of potential exposures related to 
that use until there is a specific condition of use and data to review. 
EPA's standard for an affirmative finding is consistent with the 
statutory language requiring a reasonable potential for exposure 
(rather than a certainty of exposure.
    As stated in the supplemental proposal, 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. During the public comment 
period for the 2020 supplemental proposal (Ref. 2), several commenters 
asked EPA to define ``surface coating'' and to include a definition in 
the regulatory text. EPA does not intend to finalize a regulatory 
definition of ``surface coating.'' Rather, EPA will be issuing guidance 
within a reasonable timeframe of the final rule. EPA is not defining 
this term due to the many different ways that LCPFAC chemical 
substances could be applied to an article as part of a surface coating 
and how a given article could move through the supply chain from 
manufacture to disposal. EPA believes that this approach ensures that 
EPA will have the opportunity to conduct a detailed consideration of 
potential exposures related to these uses when there is a specific 
condition of use to review. If EPA receives a SNUN, EPA will evaluate 
the potential releases from the article with information specific to 
that article.
    Articles that have surface coatings that contain certain LCPFAC 
chemical substances that have been cured or undergone chemical reaction 
after being applied to an article are subject to this rule. Even when 
LCPFAC are bound within the matrix of the coating, they can still be 
released from the coating over time and present a reasonable potential 
for exposure. These surface coatings have been unambiguously shown to 
be a source of LCPFAC in the environment (Refs. 23, 25, 27, and 28), 
even when adhered to surfaces in accordance with practices reported in 
patents (Refs. 23 and 25), and hence, present the reasonable potential 
for exposure to the chemical substance through the category of articles 
subject to the rule.
    As noted in Unit V. of the proposed rule (Ref.1), EPA is retaining 
the exemption at 40 CFR 721.45(f) for persons who process chemical 
substances as part of articles because existing stocks of articles 
still contain LCPFAC or perfluoroalkyl sulfonate chemical substances. 
EPA considers recycling to be a form of processing (Ref. 29). Because 
the processing of articles containing LCPFAC or perfluoroalkyl 
sulfonate chemical substances is ongoing, it cannot be subject to a 
SNUR. If EPA finds reason to believe that the processing of articles 
containing LCPFAC or perfluoroalkyl sulfonate chemical substances has 
ceased, EPA may issue a future SNUR on the processing of articles that 
contain these chemical substances. See Comment-Response 7 in the 
Response to Comment document for additional discussion of the ongoing 
processing of these chemical substances (Ref. 3).

[[Page 45115]]

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 and perfluoroalkyl sulfonate chemical substances that are 
designated in the January 21, 2015, proposal (Ref. 1) and the March 3, 
2020, supplemental proposal (Ref. 2):
    1. EPA would receive notice of any person's intent to manufacture 
(including import) or process 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 manufacturing or 
processing 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. Significant New Use Determination

    According to TSCA section 5(a)(2), 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:
    1. The projected volume of manufacturing and processing of a 
chemical substance.
    2. The extent to which a use changes the type or form of exposure 
of human beings or the environment to a chemical substance.
    3. The extent to which a use increases the magnitude and duration 
of exposure of human beings or the environment to a chemical substance.
    4. 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 
perfluoroalkyl sulfonate chemical substances subject to this final 
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., since the manufacture (including 
import) and processing of LCPFAC and perfluoroalkyl sulfonate chemical 
substances for these uses has been discontinued in the United States, 
exposure will decrease over time. EPA expects their presence in humans 
and the environment to decline over time. If any of the new uses of 
LCPFAC and perfluoroalkyl sulfonate chemical substances were to resume 
after having been phased out, EPA believes that such uses 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 determined the following uses are significant 
new uses:
     Manufacturing (including importing) or processing of 
LCPFAC chemical substances listed in the list of LCPFAC chemical 
substances in Unit II. for any use that is no longer ongoing after 
December 31, 2015.
     Manufacturing (including importing) or processing of PFOA 
or its salts for any use not ongoing as of the date on which the 
proposed rule was published (Ref. 1).
     Manufacturing (including importing) or processing of all 
other LCPFAC chemical substances for any use not ongoing as of January 
21, 2015, the date on which the proposed rule was published (Ref. 1).
    EPA believes any new use of certain LCPFAC chemical substances as 
part of a surface coating of an article could increase the duration and 
magnitude of human and environmental exposure to the chemical 
substances, as discussed in the March 3, 2020, supplement to proposed 
SNUR (Ref. 2). Based on these considerations, EPA has determined that: 
Importing LCPFAC chemical substances listed in the list of LCPFAC 
chemical substances in Unit II. and PFOA or its salts (See Unit I. for 
examples of PFOA salts) as part of a surface coating of an article, for 
uses not ongoing as of the date on which the 2015 proposed rule was 
published (Ref. 1), constitutes a significant new use and warrants 
making the exemption at 40 CFR 721.45(f) inapplicable to importers of 
such articles.
    Evidence supports that there is a reasonable potential for exposure 
to the chemical substances subject to this SNUR through their 
importation as part of a surface coating of an article. EPA should have 
an opportunity to review such uses before they can resume. Persons 
subject to this SNUR are required to notify EPA at least 90 days prior 
to commencing manufacture (including import) or processing of the 
chemical substances for the new use. This required notification 
provides EPA with the opportunity to evaluate any intended significant 
new use of the regulated chemical substances and, if necessary, an 
opportunity to protect against potential unreasonable risks.
    EPA has determined that the import of fluoropolymer dispersions and 
emulsions and articles containing fluoropolymers in articles is not a 
significant new use because, at the time of the 2015 proposed rule, EPA 
believed this use to be ongoing and did not propose to include this use 
in the SNUR. Ongoing uses cannot be subject to a SNUR. Since proposing 
the SNUR in 2015, EPA has received comment that the use fluoropolymer 
dispersions and emulsions made with PFOA has ceased. Because EPA did 
not propose and take comment on lifting the exemption for the import of 
fluoropolymer dispersions and emulsions, and fluoropolymers as part of 
articles, EPA has not included it in this final rule. At this time, EPA 
is not making inapplicable any of the standard exemptions at 40 CFR 
721.45 for fluoropolymer dispersions and emulsions, and fluoropolymers 
as part of articles. Yet, EPA may issue a future SNUR on the 
manufacture and processing of fluoropolymer dispersions and emulsions 
and articles containing fluoropolymers.
    In a previous rule (78 FR 62443, October 22, 2013; FRL-9397-1), EPA 
designated all uses of the perfluoroalkyl sulfonate 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 has determined that the manufacture (including import) and 
processing of any of the perfluoroalkyl sulfonate chemical substances 
subject to this rule have been discontinued, including the importing of 
these chemical substances as part of carpets. EPA believes any new use 
of perfluoroalkyl sulfonate chemicals substances as part of carpets 
could increase the duration and magnitude of human and environmental 
exposure to the chemical substances, as discussed in the January 21, 
2015, proposed SNUR (Ref. 1). The category of articles subject to the 
SNUR has not been modified since the 2015 proposed rule; therefore, EPA 
does not need to modify any of its considerations in order to make the 
finding under section 5(a)(5). Based on the information provided in the 
2015 proposed SNUR, EPA affirmatively finds under TSCA section 5(a)(5) 
that notification for import is justified by the reasonable potential 
for exposure to perfluoroalkyl sulfonate chemicals as part of carpets. 
Based on these

[[Page 45116]]

considerations, EPA has determined that: Importing perfluoroalkyl 
sulfonate chemicals identified in 40 CFR 721.9582 as part of carpets, 
which were not ongoing as of January 21, 2015, the date on which the 
proposed rule was published (Ref. 1), constitutes a significant new use 
and warrants making the exemption at 40 CFR 721.45(f) inapplicable to 
importers of carpets.

V. Applicability of the General Provisions

    The general provisions for SNURs appear under 40 CFR part 721, 
subpart A, and they apply to this rule except as modified by the rule. 
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 making the exemption at 40 CFR 721.45(f) 
inapplicable to persons who import LCPFAC chemicals substances listed 
in the list of LCPFAC chemical substances in Unit II. and PFOA or its 
salts as part of a surface coating of an article (See Unit I. for 
examples of PFOA salts). Additionally, EPA is making the exemption at 
40 CFR 721.45(f) inapplicable to persons who import perfluoroalkyl 
sulfonate chemicals substances listed in 40 CFR 721.9582 as part of 
carpets. As a result, persons subject to the provisions of this final 
rule would not be exempt from submitting a significant new use notice 
if they import those LCPFAC chemical substances, including PFOA or its 
salts, as part of a surface coating of an article or if they import 
perfluoroalkyl sulfonate chemical substances as part of carpets. 
However, EPA is retaining the exemption at 40 CFR 721.45(f) for persons 
who process chemical substances as part of an article because existing 
stocks of articles may still contain LCPFAC or perfluoroalkyl sulfonate 
chemical substances. Provisions relating to user fees appear at 40 CFR 
part 700. Additionally, TSCA, as amended by the Lautenberg Act, makes 
the provision at 40 CFR 721.45(h) inapplicable.
    According to 40 CFR 721.1(c), persons subject to SNURs must comply 
with the same notice requirements and EPA regulatory procedures as 
described in 40 CFR part 720 for submitters of Premanufacture Notices 
(PMNs) under TSCA section 5(a)(1)(A), at least to the extent there is 
no conflict with the provisions at part 721. In addition, the 
information submission requirements of TSCA sections 5(b) and 5(d)(1) 
and the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), 
and (h)(5) apply to SNURs.
    Once EPA receives a SNUN, EPA must either determine that the 
significant new use is not likely to present an unreasonable risk of 
injury or take such other regulatory action as is required by TSCA 
section 5(a)(3) before the manufacturing (including importing) or 
processing for the significant new use can commence. If EPA determines 
that the significant new use is not likely to present an unreasonable 
risk, EPA is required under TSCA section 5(g) to make public, and 
submit for publication in the Federal Register, a statement of EPA's 
finding.
    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 final 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 requiring import 
certification for these chemical substances as part of articles. The 
EPA policy on import certification appears at 40 CFR part 707, subpart 
B.

VI. 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) (FRL-3658-5) (Ref. 30), EPA has decided that the intent of TSCA 
section 5(a)(1)(B) best served by designating a use as a significant 
new use as of the date of publication of the proposed rule (including 
the posting of a pre-publication copy of the 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 significant new uses, because a 
person could defeat the SNUR by initiating the proposed significant new 
use before the rule became final, and then argue that the use was 
ongoing as of the effective date of the final rule. Thus, persons who 
began commercial manufacture or processing of LCPFAC and perfluoroalkyl 
sulfonate chemical substances after the proposal was published on 
January 21, 2015, must cease such activity before the effective date of 
this final rule. These persons would have to comply with all applicable 
SNUR notice requirements and wait to resume the commercial manufacture 
or processing of the subject chemical substances until EPA has made a 
determination. 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 would be 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. Public commenters on the proposed 
rule and the supplement to the proposal identified ongoing uses, which 
have been captured in the Response to Comments in Unit XII. (Ref. 3) 
and are not covered by this SNUR. Ongoing uses cannot be subject to a 
SNUR.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not usually require 
developing new information (e.g., generating test data) before 
submission of a SNUN; however, there is an exception: development of 
information is required where the chemical substance subject to the 
SNUR is also subject to a rule, order, or consent agreement under TSCA 
section 4 (see TSCA section 5(b)(1)). Also pursuant to TSCA section 
4(h), which pertains to reduction of testing of vertebrate animals, EPA 
encourages consultation with the Agency on the use of alternative test 
methods and strategies (also called New Approach Methodologies or 
NAMs), if available, to generate any recommended test data. EPA 
encourages dialogue with Agency representatives to help determine how 
best the submitter can meet both the data needs and the objective of 
TSCA section 4(h).
    In the absence of a TSCA section 4 test rule covering the chemical 
substance, persons are required to submit only information in their 
possession or control and to describe any other information 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 information that would permit a reasoned evaluation 
of risks posed by the chemical substance

[[Page 45117]]

during its manufacturing (including importing), 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 
information it believes may be useful in evaluating a significant new 
use.
    Submitting a SNUN that does not itself include information 
sufficient to permit a reasoned evaluation may increase the likelihood 
that EPA will either respond with a determination that the information 
available to the Agency is insufficient to permit a reasoned evaluation 
of the health and environmental effects of the significant new use or, 
alternatively, that in the absence of sufficient information, the 
manufacturing (including importing), processing, distribution in 
commerce, use, or disposal of the chemical substance may present an 
unreasonable risk of injury to health or the environment.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs and define the terms of any potentially necessary 
controls if the submitter provides detailed information on human 
exposure and environmental releases that may result from the 
significant new uses of the chemical substance.

VIII. SNUN Submissions

    EPA recommends that submitters consult with the Agency prior to 
submitting a SNUN to discuss what information 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 chemical 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.

IX. 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 final rule (Ref. 4). 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 
$7,100), 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)). 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 final SNUR. EPA's complete 
economic analysis is available in the public docket for this rule (Ref. 
4).

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 each calendar year 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).

C. Import of Chemical Substances as Part of an Article

    In making inapplicable the exemption relating to persons who import 
certain LCPFAC chemical substances as part of the surface coating of an 
article, this action may affect firms that plan to import types of 
articles that may contain the subject chemical substances in a surface 
coating. This is because while some firms have an understanding of the 
contents of the articles they import other firms do not. 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 
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. 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 Understanding the Costs Associated with Eliminating 
Exemptions for Articles in SNURs (Ref. 31). Based on available 
information, EPA believes 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 those companies choosing 
to undertake actions to assess the composition of the articles they 
import, EPA expects that importers will 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 final rule (Ref. 4).

X. Alternatives

    Before proposing this SNUR, EPA considered the following 
alternative regulatory action: 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 
manufacture (including import) or process a chemical substance for a 
specific use or any use. However, for LCPFAC and perfluoroalkyl 
sulfonate 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), 
that action would not ensure that EPA receives timely advance notice of 
future manufacturing (including importing) or processing of LCPFAC 
chemical substances (including as part of an article and components 
thereof) for new uses that may produce changes in human and 
environmental exposures. Nor would action under 8(a) ensure that an 
appropriate determination (relevant to the risks of such manufacturing 
(including importing) or processing) has been issued prior to the 
commencement of such manufacturing (including importing) or processing. 
Furthermore, a TSCA section 8(a) rule would not ensure that 
manufacturing (including importing) or processing for the significant 
new use cannot proceed until EPA has taken 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

[[Page 45118]]

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 manufacture (including import), 
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)).
    In view of the health concerns about LCPFAC and perfluoroalkyl 
sulfonate chemical substances if used for a significant new use, EPA 
believes that a TSCA section 8(a) rule for this substance would not 
meet EPA's regulatory objectives at this time.

XI. 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), the 2020 
supplemental proposal (Ref. 2), and this final rule 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, the 2020 supplemental proposal, and 
this final rule, in Unit III. and in the references cited throughout 
the three 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 definitively.

XII. Response to Public Comment

    The Agency reviewed and considered all comments received related to 
the 2015 proposed rule (Ref. 1) and the 2020 supplement to the proposed 
rule (Ref. 2). Copies of all comments are available in the docket for 
this action (EPA-HQ-OPPT-2013-0225). Responses to all comments received 
are in the document titled: ``Response to Comments on the Proposed 
Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate 
Chemical Substances Significant New Use Rule (SNUR)'' (Ref. 3), which 
is also available in the docket. Six primary comments, covering the 
majority of the issues raised by the comments received, are included 
below.
    1. Comment: Several commenters claimed ongoing uses of LCPFAC, 
PFOA, or perfluoroalkyl sulfonate chemical substances and requested 
that EPA modify the proposed SNUR to specifically recognize and exclude 
from the definition of 'significant new uses' certain ongoing 
activities that do not appear to have been previously identified by the 
Agency to be ongoing. Some commenters reiterated ongoing uses that EPA 
had already identified as ongoing. One commenter suggested that EPA 
should define ongoing uses ``in a manner that is not company 
specific.'' Several commenters requested that EPA designate ``use in 
semiconductor processing, manufacturing or semiconductor component 
assembly'' as not a significant new use for LCPFAC chemical substances 
and maintain the exemption under 40 CFR 721.45(f) for all on-going uses 
in the semiconductor industry. Two commenters asked EPA to exempt 
medical supplies or other equipment that may be used during the COVID-
19 public health emergency. See the Response to Comment document (Ref. 
3) for the specific Docket IDs for these comments.
    Response: EPA reviewed all ongoing use claims, requested additional 
information from commenters to clarify the claims, and has recognized 
and excluded from the definition of 'significant new uses' certain 
ongoing activities for certain chemicals. Exclusions from the 
definition of 'significant new uses' are included with the regulation 
amendment at 40 CFR 721.10536(b)(5).
    While reviewing ongoing use claims, EPA found chemical substances 
that did not fall within the scope of the SNUR. Additionally, during 
communication with commenters that supplied ongoing use claims, EPA 
discovered that in some instances commenters had ceased the use of 
their reported chemical substance. Accordingly, EPA has not recognized 
and excluded from the definition of 'significant new uses' ongoing use 
claims that fall outside the scope of the SNUR, have ceased by the date 
of issuance of the final rule, or were unable to be substantiated.
    During the comment response process, EPA reached out to one 
commenter who was unable to supply substantiation of their claim, yet 
stated that their ongoing use claim was captured in communication from 
the supplier directly with EPA. As such, their ongoing use claim was 
reviewed and has been addressed in the comment submitted by commenter's 
supplier.
    With regards to the use of LCPFAC chemical substances by the 
semiconductor industry, it has not been EPA's practice to identify an 
industry as a whole when recognizing ongoing uses. Commenters stated 
that LCPFAC chemical substances used in the semiconductor industry may 
be present in surfactants, coatings, seals, gaskets, hoses, motors, 
electrical wiring, tools, robots, parts, ancillary equipment, and other 
components but were unable to provide specific information such as a 
Safety Data Sheet or other documentation to support their claim. EPA 
was only able to verify ongoing uses within the semiconductor industry 
in a subset of the claims made, which have been recognized in 40 CFR 
721.10536.
    During public comment for the supplemental rule (Ref. 2), EPA 
received two comments stating ongoing uses of LCPFAC chemical 
substances used in medical supplies, medical equipment, and for 
pharmaceutical or biopharmaceutical research applications that may be 
important to the COVID-19 pandemic response. EPA agrees that ongoing 
uses, especially ones critical to COVID-19 pandemic response, should 
not be restricted by this SNUR. TSCA section 3(2)(B) excludes devices 
regulated under the Federal Food, Drug, and Cosmetic Act from the 
definition of a chemical substance under TSCA. Gloves (21 CFR 
880.6250), gowns (21 CFR 880.6265), and masks are all listed

[[Page 45119]]

separately as devices in FDA's regulations and such devices would not 
be covered by this SNUR. However, it is important to note that other 
face masks, gloves, and personal protective equipment that are marketed 
to the general public for general, non-medical purposes, would be 
covered by the SNUR if the use is not ongoing. As with other verified 
ongoing uses, EPA has also exempted the ongoing uses of certain LCPFAC 
chemical substances used in pharmaceutical and biopharmaceutical 
research from this rule. EPA, however, has not broadly exempted all 
uses of LCPFAC chemical substances used in pharmaceutical and 
biopharmaceutical research because only a select number of applications 
are ongoing.
    When possible, EPA has made explicit chemical and use specific 
exclusions from the definition of `significant new uses' rather than 
broad industry or categorical exclusions. As reflected by the 
exclusions in the final rule, ongoing activities include manufacturing 
(including import) or processing of these chemical substances. EPA will 
continue to work with industry to phase out LCPFAC, PFOA and its salts, 
and perfluoroalkyl sulfonate chemical substances and will review the 
need to promulgate future rules as necessary. As a result of public 
comments received, EPA recognizes manufacture, import, or processing of 
certain LCPFAC chemical substances for the following uses as ongoing:
     Use of LCPFAC chemical substances for use in an 
antireflective coating, photoresists, or surfactant for use in 
photomicrolithography and other process to produce semiconductors or 
similar components of electronic or other miniaturized devices.
     Use of 2-Propenoic acid, 
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl ester (CASRN 
27905-45-9) as a coating or component of a hydrophobic and/or 
oleophobic coating or barrier applied to manufactured articles or 
component of articles using an energy source or plasma deposition 
methods, which include a pulse deposition mode. Examples of such 
articles include: electronic devices and components thereof, medical 
consumables and bio-consumables, filtration devices and filtration 
materials, clothing, footwear and fabrics.
     Use of Silane, 
trichloro(3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl)-
(CASRN 78560-44-8) as a surface treatment to make low refractive index 
resin for optical applications; surface treatment for minerals, 
particles and inorganic surfaces for hydrophobicity; and monomer to 
make specialty resins hydrophobic.
     Use of Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro- (CASRN 335-67-1) as a surfactant and coating as part 
of the following articles: Stickers, labels, and parts to which those 
stickers and labels are attached.
     Use of 1-Propanesulfonic acid, 2-methyl-, 2-[[1-oxo-3-
[(.gamma.-.omega.-perfluoro-C4-16-alkyl)thio]propyl]amino] derivs., 
sodium salts (CASRN 68187-47-3); Thiols, C8-20, .gamma.-.omega.-
perfluoro, telomers with acrylamide (CASRN 70969-47-0);or 
Perfluorinated polyamine (generic) (ACC274147) as a component in fire 
extinguishing agent.
     Use of Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro- (CASRN 335-67-1); Octanoic acid, 
2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-pentadecafluoro-, sodium salt (1:1) (CAS 
No. 335-95-5); or Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro-, ammonium salt (1:1) (CASRN 3825-26-1) in automotive 
articles, both in factory assembly and replacement parts.
     Use of Poly(difluoromethylene), .alpha.,.alpha.'-
[phosphinicobis(oxy-2,1-ethanediyl)]bis[.omega.-fluoro-, ammonium salt 
(1:1) (CASRN 65530-70-3); Poly(difluoromethylene), .alpha.-
fluoro-.omega.-[2-(phosphonooxy)ethyl]-, ammonium salt (1:1) (CASRN 
65530-71-4); or Poly(difluoromethylene), .alpha.-fluoro-.omega.-[2-
(phosphonooxy)ethyl]-, ammonium salt (1:2) (CAS No. 65530-72-5) in the 
manufacturing of architectural coatings or wood coatings, at a maximum 
concentration of 0.1% by weight.
     Use of Poly(difluoromethylene), .alpha.,.alpha.'-
[phosphinicobis(oxy-2,1-ethanediyl)]bis[.omega.-fluoro-, ammonium salt 
(1:1) (CASRN 65530-70-3); Poly(difluoromethylene), .alpha.-
fluoro-.omega.-[2-(phosphonooxy)ethyl]-, ammonium salt (1:1) (CASRN 
65530-71-4); or Poly(difluoromethylene), .alpha.-fluoro-.omega.-[2-
(phosphonooxy)ethyl]-, ammonium salt (1:2) (CAS No. 65530-72-5) in the 
manufacturing of industrial primer coatings for non-spray applications 
to metal by coil coating application, at a maximum concentration of 
0.01% by weight.
     Use of Alcohols, C8-14, .gamma.-.omega.-perfluoro (CASRN 
68391-08-2) in the manufacture of coatings and finishes for a variety 
of textile, leather, and hard surface treatments, and in the 
manufacture of wetting agents.
     Use of Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-
hydroxy-, ether with .alpha.-fluoro-.omega.-(2-
hydroxyethyl)poly(difluoromethylene) (1:1) (CASRN 65545-80-4) in water-
based inks.
     Use of Poly(difluoromethylene), .alpha.-[2-[(2-
carboxyethyl)thio]ethyl]-.omega.-fluoro-, lithium salt (1:1) (CASRN 
65530-69-0) in photo media coatings.
     Use of Ethanol, 2,2'-iminobis-, compd. with .alpha.-
fluoro-.omega.-[2-(phosphonooxy)ethyl] poly(difluoromethylene) (2:1) 
(CASRN 65530-63-4); Ethanol, 2,2'-iminobis-, compd. with 
.alpha.,.alpha.'-[phosphinicobis(oxy-2,1-ethanediyl)]bis[.omega.-
fluoropoly(difluoromethylene)] (1:1) (CASRN 65530-64-5); or Ethanol, 
2,2'-iminobis-, compd. with .alpha.-fluoro-.omega.-[2-
(phosphonooxy)ethyl]poly(difluoromethylene) (1:1) (CASRN 65530-74-7) in 
paints and coatings, grouts, and sealers.
     Use of Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-
hydroxy-, ether with .alpha.-fluoro-.omega.-(2-
hydroxyethyl)poly(difluoromethylene) (1:1) (CASRN 65545-80-4) in 
paints, coatings, ink jet inks, and ink masterbatch.
     Use of 1-Propanesulfonic acid, 2-methyl-, 2-[[1-oxo-3-
[(.gamma.-.omega.-perfluoro-C4-16-alkyl)thio]propyl]amino] derivs., 
sodium salts (CASRN 68187-47-3) in adhesives.
    2. Comment: Several commenters believe that the lack of LCPFAC CAS 
numbers and the generic identification of PFOA and its salts provide 
insufficient information for entities to understand what chemicals the 
rule encompasses. They believe that EPA must define the universe of 
covered chemicals that would be subject to the regulation. See the 
Response to Comment document (Ref. 3) for the specific Docket IDs for 
these comments.
     Response: TSCA section 26(c) expressly recognizes that an 
action may be taken with respect to a category of chemical substances 
or mixtures based on chemical structure, and EPA believes the most 
precise way to identify the chemicals subject to this SNUR is through 
the chemical structure definition. Downstream customers should have 
sufficient information from suppliers (i.e., CAS registry number and 
unique chemical identity) to generate the specific structure for any 
potentially reportable substance and compare to the LCPFAC category 
definition.
    As a convenience to the regulated community, EPA has made available 
in the public docket an illustrative list of

[[Page 45120]]

chemical substances subject to the rule (Ref. 32). As part of that 
list, EPA has provided specific examples of chemicals that meet the 
various components of the LCPFAC category definition. The list is not 
exhaustive, but rather provides a guide to help readers determine 
whether this rule applies to them.
    Additionally, Congress added certain active LCPFAC chemical 
substances to the Toxics Release Inventory (TRI) list. These chemicals 
were added to the TRI list under section 7321(b)(1) of the National 
Defense Authorization Act of fiscal year 2020. TRI added both LCPFAC 
and perfluoroalkyl sulfonate chemical substances that were identified 
as active in commerce on the TSCA inventory that was published in 
February 2019. While this list includes only LCPFAC chemicals on the 
active inventory, it may assist the regulated community in determining 
whether or not a given chemical substance is subject to this rule. The 
list can be found on EPA's website and a citation is included in Unit 
XIII. (Ref. 33).
    3. Comment: Several commenters provided 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. Some comments supported the establishment of a 
threshold while others opposed the idea of a de minimis threshold. One 
commenter recommended a standard default de minimis threshold of 0.1% 
for articles for all SNURs. One commenter did not have an opinion on 
the establishment of a threshold or as a de minimis exemption but did 
state that they were ``interested in EPA establishing a 
characterization of the `reasonable potential for exposure' what might 
be `reasonably ascertainable' with specific criteria for determining 
this.'' See the Response to Comment document (Ref. 3) for the specific 
Docket IDs for these comments.
    Response: EPA appreciates the comments received. EPA is not 
establishing a de minimis threshold for determining ``reasonable 
potential for exposure'' in this final rule. EPA will, however, 
continue to engage with interested stakeholders on this issue and 
continue to consider whether guidance for applying this standard may be 
appropriate in the future, whether as a general matter or, for 
instance, as applied to specific categories of substances or potential 
exposures.
    As a general proposition, EPA believes that TSCA section 5(a)(5) 
actions should be considered on a case-by-case basis. Each time EPA 
considers requiring notification under TSCA section 5(a)(5), EPA will 
have to consider whether the ``reasonable potential for exposure'' to 
the chemical substance through the article or category of articles 
justifies notification. Since the use designated as a significant new 
use does not currently exist, EPA is deferring a detailed consideration 
of potential exposures related to that use until there is a specific 
condition of use and data to review. If EPA receives a SNUN, EPA would 
evaluate the potential releases from the article and with information 
specific to that article.
    TSCA section 5(a)(5) does not establish an explicit threshold that 
an exposure must meet in order to be considered a ``reasonable 
potential for exposure'' or to ``justify notification.'' Rather, TSCA 
section 5(a)(5) states: ``The 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.'' If there is evidence that a 
chemical substance is or may be released from an article such that 
there is a reasonable potential of exposure to the chemical substance, 
EPA thinks the Agency can reasonably find the statutory criterion to be 
met in most or all cases.
    For this final rule, EPA believes that the reasonable potential for 
exposure was adequately demonstrated by the studies cited in both the 
2015 proposed rule (Ref. 1) and the 2020 supplement to the proposed 
rule (Ref. 2). The studies cited during the rulemaking process 
represent the exposures that could result from the significant new uses 
subject to the SNUR. In showing that releases have been documented from 
articles using LCFAC chemical substances as a surface coating (Refs. 
21, 22, 23, 24, and 25), EPA asserts that the statutory standard has 
been met to show that there is reasonable potential for exposure from 
these significant new uses. EPA also concludes, on the record before 
it, that this reasonable potential for exposure justifies notification.
    4. Comment: Several commenters provided 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. Some comments supported the establishment 
of a safe harbor provision while others opposed the idea of a safe 
harbor provision. One commenter recommended that EPA ``establish a 
rebuttable presumption that a SNUN is not required for an imported 
article if the foreign supplier of that article certifies in writing 
that the article (including all components of the article) was not 
manufactured using any of the substances identified in the Supplemental 
Proposal.'' Another commenter asked that EPA allow importers to rely on 
supplier/manufacture certifications for purposes of compliance. Related 
to the idea of a safe harbor provision, several commenters emphasized 
complex supply chains that comprise many industries and the 
difficulties this would pose when determining if an article contains a 
subject chemical substance. See the Response to Comment document (Ref. 
3) for the specific Docket IDs for these comments.
    Response: EPA appreciates the comments received. EPA is not 
establishing a safe harbor provision in this final rule. EPA makes 
every effort to notify manufacturers and processors of chemical 
substances that may be subject to a given rule, so that they may 
participate in the regulatory process. EPA provided notice to importers 
in the 2015 proposed rule and again provided notice of the proposed 
requirements in the 2020 supplemental proposal. A safe harbor approach 
undermines the regulatory process for what uses are allowed by 
permitting a manufacturer to claim a use was ongoing at the time the 
SNUR was issued. For this final rule, EPA does not believe there should 
be a safe-harbor provision for uses not identified as ongoing uses in 
the SNUR, particularly since notice of the requirements of this action 
were provided five years ago. As part of the public comment period for 
the proposed rule and supplemental to the proposed rule, EPA received 
comments of ongoing uses of LCPFAC chemical substances as part of a 
surface coating on articles and has recognized those uses as ongoing 
because ongoing uses are not subject to SNURs. Similarly, a general 
safe-harbor provision may provide incentives for importers to not 
submit comments to EPA during the public comment period regarding 
ongoing uses not recognized in a proposed rule, because an importer who 
fails to submit such comments, and thus to acknowledge such uses, would 
be more easily able to claim that it did not realize the subject 
chemical substance was in its product. An importer could potentially 
use a safe harbor provision to justify a lack of involvement in a rule 
making because the importer would have the opportunity to identify 
chemicals later.

[[Page 45121]]

The importer could avoid participation early on because he could wait 
to see if anyone else submitted comments and even if there are no 
comments on his chemical use, he has the alternative to use the safe 
harbor to challenge the rule.
    While EPA acknowledges that imported articles may have a complex 
supply chain, the most effective method to ensure that certain LCPFAC 
chemical substances in this SNUR are not present in the surface coating 
of imported articles is to encourage importers to know with specificity 
the contents of what they are importing and to work with their foreign 
manufacturers to ensure that an article does not contain certain LCPFAC 
chemical substances in surface coatings.
    Even though 19 CFR 12.119 allows EPA to establish TSCA section 13 
import certification requirements for chemicals in articles, EPA did 
not propose to require TSCA section 13 import certification for the 
subject chemical substances when part of articles. Considering the use 
of these chemicals in articles covered by this SNUR are no longer 
ongoing, requiring TSCA section 13 import certification seems an 
unnecessary requirement to include in the SNUR. This is consistent with 
EPA's past practice of making the exemption at 40 CFR 721.45(f) 
inapplicable without also requiring import certification or export 
notification for these chemical substances as part of articles (40 CFR 
721.2800; 40 CFR 721.10068). With or without an import certification 
requirement, it is the importer that is ``responsible for [e]nsuring 
that chemical importation complies with TSCA just as domestic 
manufacturers are responsible for [e]nsuring that chemical manufacture 
complies with TSCA.'' 40 CFR 707.20(b)(1).
    EPA is not establishing a rebuttable presumption for this rule as 
one commenter suggested. EPA, however, may consider the factors 
discussed in EPA's import policy that may obviate or mitigate penalties 
for violations with the import of articles, as described at 40 CFR 
707.20(c)(1)(iii). The language at 40 CR 707.20(c)(1)(iii) states that 
``[ . . . ] EPA realizes that sometimes importers may not have actual 
knowledge of the chemical composition of imported mixtures. In these 
cases, the importer should attempt to discover the chemical 
constituents of the shipment by contacting another party to the 
transaction (e.g., his principal or the foreign manufacturer). This 
person may be able to identify the components of the mixture, or at 
least state that the substances comply with TSCA. The greater the 
effort an importer makes to learn the identities of the imported 
substances and their compliance with TSCA, the smaller his chance of 
committing a violation by importing a noncomplying shipment. If a 
shipment is ultimately determined to have violated TSCA, the good faith 
efforts of the importer to verify compliance, as evidenced by documents 
contained in his files, may obviate or mitigate the assessment of a 
civil penalty under section 16 of TSCA.''
    EPA recognizes the complexities of imports. EPA will take into 
consideration compliance certification and other documents 
demonstrating that the importer relied on the supplier. EPA will also 
continue to engage with interested stakeholders on how to ensure 
compliance with this and future rules. Additionally, EPA maintains the 
TSCA Hotline and responds to questions from industry. responds to 
industry questions.
    5. Comment: Several commenters raised concern over the issue of 
impurities, stating that the impurity levels of PFOA and its salts 
cannot be completely eliminated. Additionally, commenters reported that 
fluorinated substances that do not fall into the scope of the SNUR may 
degrade into in-scope LCPFAC substances. One commenter stated that 
their imported article contained residual LCPFAC from the use of 
polytetrafluoroethylene (PTFE) production, outside the US; the 
commenter further indicated that their PTFE supplier is currently 
working to develop an LCPFAC-free product, but at this time the use is 
ongoing. Also, a comment stated that it is not possible for end users 
to determine the presence of a given chemical substance, making it 
difficult for determining ``intended use'' vs. ``impurity''.
    As a result of the impurity concerns, multiple commenters requested 
that EPA require suppliers to provide Certificate of Compliance to 
importers. One comment suggested that the SNUR include all 
fluoropolymer resins ``made with'' LCPFACs and exempt such products 
``made without'' LCPFACs, even if such products may nevertheless bear 
trace amounts of LCPFACs due to cross-contamination, to encourage 
importers to demonstrate compliance by obtaining Certificates of 
Compliance from their overseas suppliers. See the Response to Comment 
document (Ref. 3) for the specific Docket IDs for these comments.
    Response: To the extent the chemical substance subject to the SNUR 
is only ``unintentionally present'' at the point of foreign 
manufacture, it is already exempt from reporting by the importer as an 
imported impurity. See 40 CFR 721.45(d). As such, importers are not 
required to submit a SNUN for or report on a substance based simply on 
that substance's presence as an impurity (i.e., a chemical substance is 
unintentionally present with another chemical substance, 40 CFR 
720.3(m)). Additionally, the impurity exemption at 40 CFR 721.45(d) 
includes domestic manufacture and processing.
    EPA is aware of the issues related to perfluorinated chemical 
impurities and polymer degradation. Given that the Agency did not 
propose to require a certification procedure, it does not agree that a 
certification procedure should be specified and incorporated into the 
final rule. However, the Agency continues to study this issue and has 
not ruled out a later proposal to require import certification for 
these chemical substances as part of articles.
    With or without an import certification requirement, it is the 
importer that is ``responsible for [e]nsuring that chemical importation 
complies with TSCA just as domestic manufacturers are responsible for 
[e]nsuring that chemical manufacture complies with TSCA.'' 40 CFR 
707.20(b)(1).
    With regards to providing an additional exemption to importers on 
the basis of being unable to determine the presence of a given chemical 
substance, or an inability to determine whether a use is ``intended '' 
vs. an ``impurity'', any exemption would create a safe-harbor for 
importers based on lack of knowledge, thus creating incentives for 
foreign suppliers to deliberately withhold information from importers. 
This could greatly reduce the efficacy of this SNUR.
    6. Comment: Several commenters requested that EPA consider 
promulgating TSCA section 6(a) rules to directly restrict 
perfluoroalkyl and polyfluoroalkyl substances (PFAS) and complete 
planned development of a detailed assessment to determine if PFAS 
chemical substances presents an unreasonable risk. See the Response to 
Comment document (Ref. 3) for the specific Docket IDs for these 
comments.
    Response: TSCA section 6(a) states that ``[i]f the Administrator 
determines in accordance with subsection (b)(4)(A) that the 
manufacture, processing, distribution in commerce, use, or disposal of 
a chemical or mixture, or that any combination of such activities, 
presents an unreasonable risk of injury to health or the environment'' 
the Administrator shall take action under TSCA section 6(a). While EPA 
appreciates the commenters request to promulgate a rule in accordance 
with this provision, EPA is not doing so at

[[Page 45122]]

this time. Rather, at this time EPA believes that a rule under TSCA 
section 5(a)(2), in conjunction with the 2010/2015 PFOA Stewardship 
Program, is an effective method to protect human health and the 
environment from any risks posed by LCPFAC and perfluoroalkyl sulfonate 
chemical substances.
    Through the 2010/2015 PFOA Stewardship Program, a voluntary risk 
reduction program, eight major fluoropolymer and telomer manufacturers 
and processors committed to voluntarily work toward a phase-out of 
LCPFAC chemical substances (Ref. 34). As such, the reduced supply of 
long-chain perfluorinated chemicals has led industries to more quickly 
transition to alternative chemical substances, as noted in both public 
comments and industry communication. For persons subject to this SNUR, 
they are required to notify EPA at least 90 days prior to commencing 
manufacture or processing of these chemical substances. This required 
notification provides EPA with the opportunity to evaluate any 
significant new use of the regulated perfluorinated chemical substances 
and, if necessary, protect against potential unreasonable risks. EPA 
continues to review the manufacturing, import, and processing of the 
ongoing uses of these substances of concern. If EPA has reason to 
believe that either a use of these chemical substances is no longer 
ongoing or that a TSCA section 6(a) rule would better regulate LCPFAC 
and perfluoroalkyl sulfonate chemical substances, EPA will consider 
taking further regulatory action.

XIII. References

    The following is a list of the documents that are specifically 
referenced in this document. The docket includes these documents, as 
well as other information considered by EPA that are not listed below, 
including documents that are referenced within the documents that are 
included in the docket. For assistance in locating docket items, 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. Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl 
Sulfonate Chemical Substances; Significant New Use Rule. 
Supplemental Proposal. Federal Register. 85 FR 12479, March 3, 2020 
(FRL-10003-21).
3. EPA. Response to Comments on the Proposed Long-Chain 
Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical 
Substances Significant New Use Rule (SNUR). June 19, 2020.
4. EPA. Economic Analysis of the Final Significant New Use Rule for 
Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl Carboxylate 
Chemical Substances. June 19, 2020.
5. 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.
6. EPA. Perfluoroalkyl Sulfonates; Significant New Use Rule; Final 
Rule. Federal Register. 67 FR 72854, December 9, 2002 (FRL-6823-6).
7. 3M Company. The Science of Organic Fluorochemistry. St. Paul, 
Minnesota, February 5, 1999.
8. 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.
9. Houde, Magali, et al. ``Biological monitoring of polyfluoroalkyl 
substances: a review.'' Environmental Science & Technology 40.11 
(2006): 3463-3473.
10. 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.
11. Lau, Christopher, et al. ``Perfluoroalkyl acids: a review of 
monitoring and toxicological findings.'' Toxicological Sciences 99.2 
(2007): 366-394.
12. EPA. Health Effects Support Document for Perfluorooctanoic Acid 
(PFOA). EPA 822-R-16-003. May 2016.
13. 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.
14. Sturm R., et al. Trends of Polyfluoroalkyl Compounds in Marine 
Biota and in Humans. Environmental Chemistry. 7: 457-484. 2010.
15. Lau, C. Perfluorinated Compounds. Molecular, Clinical and 
Environmental Toxicology Experientia Supplementum. Volume 101, pp. 
47-86. 2012.
16. 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.
17. 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.
18. 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.
19. EPA. Perfluoroalkyl Sulfonates; Proposed Significant New Use 
Rule; Proposed Rule. Federal Register. 67 FR 11014, March 11, 2002 
(FRL-6823-7).
20. 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.
21. Gremmel, Christoph, et al. ``Systematic determination of 
perfluoroalkyl and polyfluoroalkyl substances (PFASs) in outdoor 
jackets.'' Chemosphere 160 (2016): 173-180.
22. 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.
23. 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.
24. Guo, Zhishi, et al. ``Perfluorocarboxylic acid content in 116 
articles of commerce.'' Research Triangle Park, NC: US Environmental 
Protection Agency (2009).
25. Washington, J.W., T.M. Jenkins, K. Rankin, J.E. Naile. 2015. 
Decades-Scale Degradation of Commercial, Side-Chain, Fluorotelomer-
based Polymers in Soils & Water. Environmental Science & Technology. 
49. 915-923.
26. Plastics Industry Association. Guide to the Safe Handling of 
Fluoropolymer Resins. Fifth Addition. 2018.
27. Washington, J.W., J.J. Ellington, T.M. Jenkins, J.J Evans, H. 
Yoo, S.C. Hafner. 2009. Degradability of an Acrylate-Linked 
Fluorotelomer Polymer in Soil. Environmental Science & Technology. 
43. 6617-6623.
28. Washington, J.W., K. Rankin, K., E.L. Libelo, D.G. Lynch, M. 
Cyterski. 2019. Determining global background soil PFAS loads and 
the fluorotelomer-based polymer degradation rates that can account 
for these loads. Science of the Total Environment. 651. 2444-2449.
29. EPA. Draft Scope of the Risk Evaluation for 1,2-Dichloroethane. 
April 2020. Accessed at: https://www.epa.gov/sites/production/files/2020-04/documents/casrn-107-06-2_12-dichloroethane_draft_scope.pdf.
30. EPA. Significant New Uses of Certain Chemical Substances; Final 
Rule. Federal Register. 55 FR 17376, April 24, 1990 (FRL-3658-5).
31. EPA. Understanding the Costs Associated with Eliminating 
Exemptions for Articles in SNURs. November 12, 2014.
32. EPA. Illustrative List of LCPFACs Update September 17, 2014.
33. EPA. Chemicals Added to the Toxics Release Inventory Pursuant to 
Section 7321 of the National Defense Authorization Act. April 1, 
2020. Accessed at: https://www.epa.gov/sites/production/files/2020-04/documents/tri_non-cbi_pfas_list_2_19_2020_final_clean.pdf.

[[Page 45123]]

34. EPA. 2010/2015 PFOA Stewardship Program Final Report. Accessed 
at: https://www.epa.gov/sites/production/files/2017-02/documents/2016_pfoa_stewardship_summary_table_0.pdf.

XIV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://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

    This action is a significant regulatory action that was submitted 
to the Office of Management and Budget (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 Significant New Use Rule for 
Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl Carboxylate 
Chemical Substances'' (Ref. 4), is available in the docket and is 
briefly summarized in Unit XI.

B. Executive Order 13771: Reducing Regulations and Controlling 
Regulatory Costs

    This is a regulatory action subject to Executive Order 13771 (82 FR 
9339, February 3, 2017). Details on the estimated costs and benefits of 
this final rule can be found in EPA's analysis (Ref. 4), 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 lower 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. 4). Based on this, 
EPA believes that few SNUN submissions will occur as a result of the 
rule. EPA believes the total cost of submitting a SNUN, $10,000 for 
small business submitters, is relatively small compared to annual 
revenues of the companies and does not have a significant economic 
impact as compared to the cost of developing and marketing a chemical 
new to a firm or marketing a new use of the chemical. This estimate 
does not include any costs associated with importer's identification of 
chemicals associated with the SNUR. While EPA does not have estimates 
on the cost of developing and marketing a new chemical, it has 
identified a mean reformulation cost of $31,700 and a maximum of 
$114,000, which is well above the $10,000 SNUN costs.
    Therefore, EPA believes that the potential economic impact of 
complying with this final SNUR is not expected to be significant or 
adversely impact 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.

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.

[[Page 45124]]

I. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This final 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.

J. National Technology Transfer and Advancement Act (NTTAA)

    Since this action does not involve any technical standards, section 
12(d) of NTTAA, 15 U.S.C. 272 note, does not apply to this action.

K. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This final rule does not invoke special consideration of 
environmental justice related issues as delineated by Executive Order 
12898 (59 FR 7629, February 16, 1994), because EPA has determined that 
this action will not have disproportionately high and adverse human 
health or environmental effects on minority or low-income populations.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801-808, and EPA will 
submit a rule report to each House of the Congress and to the 
Comptroller General of the United States. This action is not a ``major 
rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: June 22, 2020.
Andrew Wheeler,
Administrator.

    Therefore, for the reasons stated in the preamble, EPA amends 40 
CFR chapter I as follows:

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

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. Amend Sec.  721.9582 by:
0
a. Redesignating paragraph (a) as (b).
0
b. Adding new paragraph (a).
0
c. Adding paragraph (b)(2)(v).
0
d. Adding paragraph (c).
    The additions 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) * * *
    (v) 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) The provision at Sec.  721.45(h) does not apply to this 
section.

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 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; and
    (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)(2)--LCPFAC Chemical Substances Subject to Reporting After December 31, 2015
----------------------------------------------------------------------------------------------------------------
                                   CAS registry No.    EPA  accession
         Chemical name                 (CASRN)               No.              TSCA chemical inventory name
----------------------------------------------------------------------------------------------------------------
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-                        2043-54-1............             N/A  Dodecane,
 Tetrahydroperfluorododecyl                                             1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10
 iodide.                                                                ,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-                        27905-45-9...........             N/A  2-Propenoic acid,
 Tetrahydroperfluorodecyl                                               3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
 acrylate.                                                              heptadecafluorodecyl ester
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,  30046-31-2...........             N/A  Tetradecane,
 8,8,9,9,10,10,11,11,12,12-                                             1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10
 Pentacosafluoro-14-                                                    ,10,11,11,12,12-pentacosafluoro-14-iodo-
 iodotetradecane.                                                       .
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10  39239-77-5...........             N/A  1-Tetradecanol,
 ,10,11,11,12,12,13,13,14,14,1                                          3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,
 4-Pentacosafluorotetradecan-1-                                         12,12,13,13,14,14,14-pentacosafluoro-.
 ol.

[[Page 45125]]

 
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10  60699-51-6...........             N/A  1-Hexadecanol,
 ,10,11,11,12,12,13,13,14,14,1                                          3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,
 5,15,16,16,16-                                                         12,12,13,13,14,14,15,15,16,16,16-
 Nonacosafluorohexadecan-1-ol.                                          nonacosafluoro-.
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,  65510-55-6...........             N/A  Hexadecane,
 8,8,9,9,10,10,11,11,12,12,13,                                          1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10
 13,14,14-Nonacosafluoro-16-                                            ,10,11,11,12,12,13,13,14,14-
 iodohexadecane.                                                        nonacosafluoro-16-iodo-.
Sodium;2-methylpropane-1-       68187-47-3...........             N/A  1-Propanesulfonic acid, 2-methyl-, 2-[[1-
 sulfonate.                                                             oxo-3-[(.gamma.-.omega.-perfluoro- C4-16-
                                                                        alkyl)thio]propyl]amino] derivs., sodium
                                                                        salts
1,1,2,2-                        68391-08-2...........             N/A  Alcohols, C8-14, .gamma.-.omega.-
 Tetrahydroperfluoroalkyl (C8-                                          perfluoro.
 C14) alcohol.
Thiols, C8-20, gamma-omega-     70969-47-0...........             N/A  Thiols, C8-20, .gamma.-.omega.-perfluoro,
 perfluoro, telomers with                                               telomers with acrylamide.
 acrylamide.
Silicic acid (H4SiO4), sodium   125476-71-3..........             N/A  Silicic acid (H4SiO4), sodium salt (1:2),
 salt (1:2), reaction products                                          reaction products with
 with chlorotrimethylsilane                                             chlorotrimethylsilane and
 and                                                                    3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
 3,3,4,4,5,5,6,6,7,7,8,8,9,9,1                                          heptadecafluoro-1-decanol.
 0,10,10-heptadecafluoro-1-
 decanol.
Thiols, C4-20, gamma-omega-     1078712-88-5.........             N/A  Thiols, C4-20, .gamma.-.omega.-perfluoro,
 perfluoro, telomers with                                               telomers with acrylamide and acrylic
 acrylamide and acrylic acid,                                           acid, sodium salts.
 sodium salts).
1-Propanaminium, 3-amino-N-     1078715-61-3.........             N/A  1-Propanaminium, 3-amino-N-
 (carboxymethyl)-N,N-dimethyl-                                          (carboxymethyl)-N,N-dimethyl-, N-[2-
 , N-(2-((gamma-omega-                                                  [(.gamma.-.omega.-perfluoro-C4-20-a
 perfluoro-C4-20-                                                       lkyl)thio]acetyl] derivs., inner salts.
 alkyl)thio)acetyl) derivs.,
 inner salts.
Polyfluoroalkyl betaine         CBI..................           71217  Polyfluoroalkyl betaine (PROVISIONAL).
 (generic).
Modified fluoroalkyl urethane   CBI..................           89419  Modified fluoroalkyl urethane
 (generic).                                                             (PROVISIONAL).
Perfluorinated polyamine        CBI..................          274147  Perfluorinated polyamine (PROVISIONAL).
 (generic).
----------------------------------------------------------------------------------------------------------------

    (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)(3)--PFOA and Examples of Its Salts
----------------------------------------------------------------------------------------------------------------
                                            CAS registry
              Chemical name                 No.  (CASRN)                TSCA chemical inventory 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 is: 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 is: 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 is: Manufacture (including import) or 
processing for any use. Import or processing 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 is: Manufacture 
(including import) or processing for any use other than the use already 
covered by paragraph (b)(4)(i) of this section.
    (5) Manufacturing (including importing) or processing of certain

[[Page 45126]]

chemical substances identified in paragraph (b)(1), paragraph (b)(2), 
and paragraph (b)(3) of this section for the following specific uses 
shall not be considered as a significant new use subject to reporting 
under this section:
    (i) Use in an antireflective coating, photoresists, or surfactant 
for use in photomicrolithography and other processes to produce 
semiconductors or similar components of electronic or other 
miniaturized devices.
    (ii) Use of 2-Propenoic acid, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
heptadecafluorodecyl ester (CAS No. 27905-45-9) as a coating or 
component of a hydrophobic and/or oleophobic coating or barrier applied 
to manufactured articles or components of articles using an energy 
source or plasma deposition methods, which include a pulse deposition 
mode. Examples of such articles include: Electronic devices and 
components thereof, medical consumables and bio-consumables, filtration 
devices and filtration materials, clothing, footwear and fabrics.
    (iii) Use of Silane, 
trichloro(3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl)-
(CAS No. 78560-44-8) as a surface treatment to make low refractive 
index resin for optical applications; surface treatment for minerals, 
particles and inorganic surfaces for hydrophobicity; and monomer to 
make specialty resins hydrophobic.
    (iv) Use of Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro- (CAS No. 335-67-1) as a surfactant and coating, as 
part of articles: Stickers, labels, and parts to which those stickers 
and labels are attached.
    (v) Use of 1-Propanesulfonic acid, 2-methyl-, 2-[[1-oxo-3-
[(.gamma.-.omega.-perfluoro-C4-16-alkyl)thio]propyl]amino] derivs., 
sodium salts (CAS No. 68187-47-3); Thiols, C8-20, .gamma.-.omega.-
perfluoro, telomers with acrylamide (CAS No. 70969-47-0); or 
Perfluorinated polyamine (generic) (ACC274147) as a component in fire 
extinguishing agent.
    (vi) Use of Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro- (CAS No. 335-67-1); Octanoic acid, 
2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-pentadecafluoro-, sodium salt (1:1) (CAS 
No. 335-95-5); or Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro-, ammonium salt (1:1) (CAS No. 3825-26-1) for use in 
automotive articles, both in factory assembly and replacement parts.
    (vii) Use of Poly(difluoromethylene), .alpha.,.alpha.'-
[phosphinicobis(oxy-2,1-ethanediyl)]bis[.omega.-fluoro-, ammonium salt 
(1:1) (CAS No. 65530-70-3); Poly(difluoromethylene), .alpha.-
fluoro-.omega.-[2-(phosphonooxy)ethyl]-, ammonium salt (1:1) (CAS No. 
65530-71-4); or Poly(difluoromethylene), .alpha.-fluoro-.omega.-[2-
(phosphonooxy)ethyl]-, ammonium salt (1:2) (CAS No. 65530-72-5) for use 
in the manufacturing or processing of:
    (A) Architectural coatings or wood coatings, at a maximum 
concentration of 0.1% by weight.
    (B) Industrial primer coatings for non-spray applications to metal 
by coil coating application, at a maximum concentration of 0.01% by 
weight.
    (viii) Use of Alcohols, C8-14, .gamma.-.omega.-perfluoro (CAS No. 
68391-08-2) in the manufacture or processing of coatings and finishes 
for a variety of textile, leather, and hard surface treatments, and in 
the manufacture of wetting agents.
    (ix) Use of Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-
hydroxy-, ether with .alpha.-fluoro-.omega.-(2-
hydroxyethyl)poly(difluoromethylene) (1:1) (CAS No. 65545-80-4) in 
water-based inks.
    (x) Use of Poly(difluoromethylene), .alpha.-[2-[(2-
carboxyethyl)thio]ethyl]-.omega.-fluoro-, lithium salt (1:1) (CAS No. 
65530-69-0) in photo media coatings.
    (xi) Use of Ethanol, 2,2'-iminobis-, compd. with .alpha.-
fluoro-.omega.-[2-(phosphonooxy)ethyl]poly(difluoromethylene) (2:1) 
(CAS No. 65530-63-4); Ethanol, 2,2'-iminobis-, compd. with 
.alpha.,.alpha.'-[phosphinicobis(oxy-2,1-ethanediyl)]bis[.omega.-
fluoropoly(difluoromethylene)] (1:1) (CAS No. 65530-64-5); or Ethanol, 
2,2'-iminobis-, compd. with .alpha.-fluoro-.omega.-[2-
(phosphonooxy)ethyl]poly(difluoromethylene) (1:1) (CAS No. 65530-74-7) 
in paints and coatings, grouts, and sealers.
    (xii) Use of Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-
hydroxy-, ether with .alpha.-fluoro-.omega.-(2-
hydroxyethyl)poly(difluoromethylene) (1:1) (CAS No. 65545-80-4) in 
paints, coatings, ink jet inks, and ink masterbatch.
    (xiii) Use of 1-Propanesulfonic acid, 2-methyl-, 2-[[1-oxo-3-
[(.gamma.-.omega.-perfluoro-C4-16-alkyl)thio]propyl]amino] derivs., 
sodium salts (CAS No. 68187-47-3) in adhesives.
    (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 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) The provision at Sec.  721.45(h) does not apply to this 
section.

[FR Doc. 2020-13738 Filed 7-24-20; 8:45 am]
BILLING CODE 6560-50-P