Document ID: EPA-HQ-OPPT-2013-0225-0112
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use: Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances
Posted Date: 2020-03-03T05:00Z

[Federal Register Volume 85, Number 42 (Tuesday, March 3, 2020)]
[Proposed Rules]
[Pages 12479-12489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03865]

[[Page 12479]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2013-0225; FRL-10003-21]
RIN 2070-AJ99

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Supplemental notice of proposed rulemaking.

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SUMMARY: EPA is supplementing a proposed significant new use rule 
(SNUR) issued under section 5(a)(2) of the Toxic Substances Control Act 
(TSCA) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical 
substances to make inapplicable the exemption for persons who import a 
subset of LCPFAC chemical substances as part of surface coatings on 
articles. This subset of LCPFAC chemical substances also includes the 
salts and precursors of these perfluorinated carboxylates. This 
supplemental proposal would require importers to notify EPA at least 90 
days before commencing the import of these chemical substances in 
certain articles for the significant new use described in this 
document. The required significant new use notification would initiate 
EPA's evaluation of the conditions of use associated with the intended 
significant new use. Manufacturing (including import) or processing for 
the significant new use would be prohibited from commencing until EPA 
has conducted a review of the notice, made an appropriate determination 
on the notice, and taken such actions as are required in association 
with that determination.

DATES: Comments must be received on or before April 17, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2013-0225, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Tyler Lloyd, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-4016; email address: 
lloyd.tyler@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
(including import), process, or distribute in commerce chemical 
substances and mixtures. The following list of North American 
Industrial Classification System (NAICS) codes is not intended to be 
exhaustive, but rather provides a guide to help readers determine 
whether this document applies to them.
    Potentially affected entities may include:
     Apparel Manufacturing (NAICS code 315).
     Electrical Equipment, Appliance, and Component 
Manufacturing (NAICS code 335).
     Merchant Wholesalers, Durable Goods (NAICS codes 423).
     Merchant Wholesalers, Nondurable Goods (NAICS 424).
     Furniture and Home Furnishings Stores (NAICS codes 442).
     Electronics and Appliance Stores (NAICS codes 443).
     Building Material and Garden Equipment and Supplies 
Dealers (NAICS code 444).
     Clothing and Clothing Accessories Stores (NAICS code 448).
     Sporting Goods, Hobby, Musical Instrument, and Book Stores 
(NAICS code 449).
     General Merchandise Stores (NAICS code 450).
     Non-store Retailers (NAICS code 451).
    This action may affect certain entities through pre-existing import 
certification and export notification rules under TSCA. Persons who 
import any chemical substance governed by a final SNUR are subject to 
the TSCA section 13 (15 U.S.C. 2612) import certification requirements 
and the corresponding regulations at 19 CFR 12.118 through 12.127; see 
also 19 CFR 127.28. Those persons must certify that the shipment of the 
chemical substance complies with all applicable rules and orders under 
TSCA, including any SNUR requirements. The EPA policy in support of 
import certification appears at 40 CFR part 707, subpart B. 
Additionally, persons who export or intend to export a chemical 
substance that is the subject of a proposed or final SNUR are subject 
to the export notification provisions of TSCA section 12(b) (15 U.S.C. 
2611(b); see also 40 CFR part 707, subpart D and 40 CFR 721.20). Under 
the existing TSCA import certification and export notification rules, 
persons who import a chemical substance covered under this proposed 
rule as part of an article would be exempt from TSCA section 13 import 
certification, and persons who export or intend to export a chemical 
substance as part of an article would be exempt from the TSCA section 
12(b) export notification requirements. See Unit V. for more 
information on the applicability of the import certification and export 
notification requirements.
    If you have any questions regarding the applicability of this 
action to a particular entity, consult the technical information 
contact listed under FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including those listed in TSCA section 5(a)(2). 
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) states that EPA's 
determination that a use of a chemical substance is a significant new 
use must be made after consideration of all relevant factors including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.

[[Page 12480]]

     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorizes EPA to consider any other relevant factors. Once 
EPA determines that a use of a chemical substance is a significant new 
use, TSCA section 5(a)(1) requires persons to submit a significant new 
use notice (SNUN) to EPA at least 90 days before they manufacture 
(including import) or process the chemical substance for that use (15 
U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing 
or processing from commencing until EPA has conducted a review of the 
notice, made an appropriate determination on the notice, and taken such 
actions as are required in association with that determination (15 
U.S.C. 2604(a)(1)(B)(ii)). Additionally, TSCA section 5(a)(5) (15 
U.S.C. 2604(a)(5)), as amended in 2016, authorizes EPA to require 
notification for the import or processing of a chemical substance as 
part of an article or category of articles under TSCA section 5(a)(1) 
(15 U.S.C. 2604(a)(1)(A)(ii)) if EPA makes an affirmative finding in a 
rule under TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) that the 
reasonable potential for exposure to the chemical substance through the 
article or category of articles subject to the rule justifies 
notification. This supplemental proposal proposes to exercise EPA's 
authority under TSCA section 5(a)(5) to require notification for the 
import of the subject chemical substances as part of the category of 
articles, articles that contain certain LCPFAC chemical substances as 
part of a surface coating, discussed in Unit I.C. As described in Unit 
V., the general SNUR provisions are found at 40 CFR part 721, subpart 
A.

C. What action is the Agency taking?

    In the Federal Register of January 21, 2015 (80 FR 2885) (FRL-9915-
63) (Ref. 1), EPA proposed a SNUR for long-chain perfluoroalkyl 
carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances. 
As stated in the previous proposal, the LCPFAC chemical substances also 
include the salts and precursors of these perfluorinated carboxylates. 
In that previously proposed rule, EPA proposed to make the exemption 
from notification requirements for persons who import the chemical 
substance as part of an article inapplicable for the import of a subset 
of LCPFAC chemical substances in all articles. EPA is now issuing a 
supplemental proposal for the import of certain LCPFAC chemical 
substances; this action would make the exemption from notification 
requirements inapplicable and require significant new use notification 
reporting for the import of a subset of LCPFAC chemical substances only 
as part of a surface coating on articles. This supplemental proposal 
better defines the articles subject to the rule by defining the subject 
articles as ``imported articles where certain LCPFAC chemical 
substances are part of surface coating on the articles'' rather than 
what was originally proposed, ``imports of articles.'' EPA is issuing 
this supplemental proposal to be responsive to the article 
consideration provision at TSCA section 5(a)(5), added with the passage 
of the Frank R. Lautenberg Chemical Safety for the 21st Century Act 
(Pub. L. 114-182), which states that articles can be subject to 
notification requirements as a significant new use if the Administrator 
makes an affirmative finding in a rule that the reasonable potential 
for exposure to a chemical from an article or category of articles 
justifies notification. Rather than making the article exemption 
inapplicable for any article, as was proposed in the January 21, 2015, 
proposal (Ref. 1), this action proposes to make a finding under TSCA 
section 5(a)(5) and make the article exemption at 40 CFR 721.45(f) 
inapplicable for persons importing the category of articles that 
contain certain LCPFAC chemical substances as part of a surface coating 
on articles. As to processors, it is EPA's understanding that there is 
no ongoing manufacturing or processing of LCPFAC chemical substances in 
the U.S. Based on that understanding, EPA does not expect that there 
would be any future such processing, and EPA therefore is not proposing 
that this Supplemental Proposed Rule apply to processors. EPA seeks 
comment on this approach.
    In the proposed rule issued in the Federal Register of January 21, 
2015 (Ref. 1), EPA also proposed: (1) An amendment to a SNUR for LCPFAC 
chemical substances by designating as a significant new use 
manufacturing (including importing) or processing of a subset of LCPFAC 
chemical substances for any use that was no longer ongoing after 
December 31, 2015; (2) an amendment to a SNUR for LCPFAC chemical 
substances by designating as a significant new use manufacturing 
(including importing) or processing of all other LCPFAC chemicals 
substances for any use that was no longer ongoing after January 21, 
2015; and (3) an amendment to a SNUR for perfluoroalkyl sulfonate 
chemical substances that would make inapplicable the exemption from 
notification requirements for persons who import perfluoroalkyl 
sulfonate chemical substances as part of carpets. These other 
amendments, as proposed on January 21, 2015 (Ref. 1), are not the 
subject of this supplemental proposal. EPA is considering the comments 
received on the January 21, 2015, proposal (Ref. 1) and will respond to 
them with publication of the final rule.
    During the public comment period for the rule proposed in the 
Federal Register of January 21, 2015 (Ref. 1), EPA received comments 
about ongoing uses of LCPFAC and perfluorooctanoic acid (PFOA) chemical 
substances and requests that EPA modify the proposed SNUR to 
specifically recognize and exclude from the significant new uses 
certain ongoing activities. EPA received public comments claiming 
several ongoing uses. EPA continues to review these claims of ongoing 
use to understand whether these uses remain ongoing. EPA intends to 
undertake further outreach to commenters to confirm and better 
understand the ongoing uses. In the final rule, EPA will recognize and 
exclude from the significant new uses any ongoing activities for these 
chemicals. The final rule would take final action on both the 
previously proposed rule and this supplemental proposal. For further 
background information for this supplemental proposal, consult the 
proposal issued in the Federal Register of January 21, 2015 (Ref. 1) 
and the corresponding docket for this rulemaking (EPA-HQ-OPPT-2013-
0225).
    This supplemental proposal to the proposed SNUR would require 
persons who intend to import these LCPFAC chemical substances as part 
of a surface coating on articles for a significant new use, consistent 
with the requirements at 40 CFR 721.25, to notify EPA at least 90 days 
before commencing such import. This supplemental proposal to the 
proposed SNUR would furthermore preclude the commencement of import of 
such articles until EPA has conducted a review of the notice, made an 
appropriate determination on the notice, and taken such actions as are 
required in association with that determination. As discussed in the 
Federal Register of April 24, 1990 (55 FR 17376), EPA has decided that 
the intent of the TSCA section 5(a)(1)(B) is best served by designating 
a use as a significant new

[[Page 12481]]

use as of the date of publication of the proposed rule rather than as 
of the effective date of the final rule. This rule was proposed on 
January 21, 2015. Uses arising after the publication of the proposed 
rule are distinguished from uses that exist at publication of the 
proposed rule. The former would be new uses, the latter ongoing uses, 
except that uses that are ongoing as of the publication of the proposed 
rule would not be considered ongoing uses if they have ceased by the 
date of issuance of a final rule.

D. Why is the Agency taking this action?

    Enacted on June 22, 2016, the Frank R. Lautenberg Chemical Safety 
for the 21st Century Act (Pub. L. 114-182) amended several sections of 
TSCA and added section 5(a)(5), Article Consideration. As a 
precondition to authorizing EPA to ``require notification under this 
section for the import or processing of a chemical substance as part of 
an article or category of articles under paragraph (1)(A)(ii),'' this 
provision requires that EPA affirmatively find in a rule under section 
5(a)(2) that the reasonable potential for exposure to a chemical 
substance through the article or category of articles justifies 
notification. After considering the reasonable potential for exposure 
from articles under TSCA section 5(a)(5), EPA is now issuing a 
supplemental proposal to make inapplicable the exemption for persons 
who import certain LCPFAC chemical substances when those LCPFAC 
chemical substances are part of a surface coating on articles.
    If finalized as proposed, the January 21, 2015, proposed SNUR would 
require timely advance notice to EPA of any future import of LCPFAC 
chemical substances for new uses that may produce changes in human and 
environmental exposures, and would ensure that an appropriate 
determination (relevant to the risks associated with such importing, 
processing, and use) has been issued prior to the commencement of such 
importing. The proposed SNUR is furthermore necessary to ensure that 
manufacturing (including importing) or processing for the significant 
new use cannot proceed until EPA has responded to the circumstances by 
taking the required actions under TSCA sections 5(e) or 5(f) in the 
event that EPA determines any of the following: (1) That the 
significant new use presents an unreasonable risk under the conditions 
of use (without consideration of costs or other non-risk factors, and 
including an unreasonable risk to a potentially exposed or susceptible 
subpopulation identified as relevant by EPA); (2) that the information 
available to EPA is insufficient to permit a reasoned evaluation of the 
health and environmental effects of the significant new use; (3) that, 
in the absence of sufficient information, the manufacturing (including 
importing), processing, distribution in commerce, use, or disposal of 
the substance, or any combination of such activities, may present an 
unreasonable risk (without consideration of costs or other non-risk 
factors, and including an unreasonable risk to a potentially exposed or 
susceptible subpopulation identified as relevant by EPA); or (4) that 
there is substantial production and sufficient potential for 
environmental release or human exposure (as defined in TSCA section 
5(a)(3)(B)(ii)(II)).
    The rationale and objectives for this supplemental proposal are 
explained in Unit III.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs of establishing SNUR 
reporting requirements for potential importers of articles containing 
the chemical substances included in this supplemental proposal when 
they are part of a surface coating on articles. This analysis (Ref. 2), 
which is available in the docket, is discussed in Unit IX., and is 
briefly summarized here.
    In the event that a SNUN is submitted, costs are estimated to be 
approximately $23,000 per SNUN submission for large business submitters 
and about $10,000 for small business submitters. The rule may also 
affect firms that plan to import or process articles that may be 
subject to the SNUR. Although there are no specific requirements in the 
rule for these firms, they may choose to undertake some activity to 
assure themselves that they are not undertaking a significant new use. 
In the accompanying Economic Analysis for this SNUR (Ref. 2), EPA 
provides example steps (and their respective costs) that an importer or 
processor might take to identify LCFPAC chemical substances in 
articles. These can include gathering information through agreements 
with suppliers, declarations through databases or surveys, or use of a 
third-party certification system. Additionally, importers may require 
suppliers to provide certificates of testing analysis of the products 
or perform their own laboratory testing of certain articles. EPA is 
unable to predict, however, what, if any, particular steps an importer 
might take; thus, potential total costs were not estimated.

F. Do you have comments or information about ongoing uses?

    EPA welcomes comment on all aspects of this supplemental proposal. 
EPA based its understanding of the use profile of these chemicals on 
the published literature, company progress reports submitted during the 
2010/2015 PFOA Stewardship Program, the 2016 CDR submissions, market 
research, and review of Safety Data Sheets. To confirm EPA's 
understanding, the Agency is requesting public comment on all aspects 
of this supplemental proposal. In providing comments on the reasonable 
potential for exposure to LCPFAC chemical substances in articles, 
commenters are urged to provide sufficient information for EPA to 
substantiate any assertions of use and of exposure. Additionally, EPA 
requests comment on the assumption that article importers that choose 
to investigate their products will incur costs at the lower end of the 
ranges presented in the Economic Analysis for this supplemental 
proposed rule.

G. Additional Considerations for Comment

    TSCA section 5(a)(5) provides that the EPA Administrator ``may 
require notification under this section for the import or processing of 
a chemical substance as part of an article or category of articles 
under paragraph (1)(A)(ii) if the Administrator makes an affirmative 
finding in a rule under paragraph (2) that the reasonable potential for 
exposure to the chemical substance through the article or category of 
articles subject to the rule justifies notification.'' (Emphasis 
added.) Thus, Congress provided EPA with considerable discretion to 
determine (1) what is a ``reasonable'' potential for exposure; (2) what 
kind of reasonable potential ``justifies'' notification; and (3) 
whether, in EPA's discretion (``may require''), to require notification 
in a case in which such a reasonable potential exists. By making 
notification contingent on the existence of a ``reasonable'' potential 
for exposure, TSCA section 5(a)(5) implies that there is some category 
of less than reasonable potentials for exposure that could not give 
rise to notification.
    EPA requests comment on whether or not the Agency should 
affirmatively establish an explicit threshold at which, or explicit 
criteria for determining whether, a significant new use exhibits a 
reasonable potential for exposure that justifies notification. While 
TSCA section 5(a)(5) does not establish a specific threshold or 
specific criteria for making this determination and does not

[[Page 12482]]

require EPA to affirmatively establish such a threshold or such 
criteria, EPA may establish a threshold, or criteria, for determining 
reasonable potential for exposure if appropriate.
    EPA seeks comment on whether EPA could adopt a de minimis threshold 
for determining ``reasonable potential for exposure'' and if so, how 
that de minimis threshold could be established. For example, the United 
States Court of Appeals for the District of Columbia Circuit has 
recognized that ``[u]nless Congress has been extraordinarily rigid, 
there is likely a basis for an implication of de minimis authority to 
provide exemption when the burdens of regulation yield a gain of 
trivial or no value.'' Alabama Power Co. v. Costle, 636 F.2d 323, 360-
61 (D.C. Cir. 1980).
    In Alabama Power, the Court has recognized that ``[c]ategorical 
exemptions from statutory commands may . . . be permissible as an 
exercise of agency power, inherent in most statutory schemes, to 
overlook circumstances that in context may fairly be considered de 
minimis. It is commonplace, of course, that the law does not concern 
itself with trifling matters, and this principle has often found 
application in the administrative context. Courts should be reluctant 
to apply the literal terms of a statute to mandate pointless 
expenditures of effort.'' 636 F.2d at 360 (citations omitted). ``The 
ability . . . to exempt de minimis situations from a statutory command 
is not an ability to depart from the statute, but rather a tool to be 
used in implementing the legislative design.'' Id. Courts have 
continued to recognize that authority to create de minimis exemptions 
may be implied where ``the burdens of regulation yield a gain of 
trivial or no value.'' Envtl. Def. Fund, Inc. v. EPA, 82 F.3d 451, 466 
(D.C. Cir. 1996) (internal quotation marks omitted); see also, e.g., 
Ass'n of Admin Law Judges v. FLRA, 397 F.3d 957, 961-62 (D.C. Cir. 
2005). As an application of the statutory requirements in the context 
of this specific Significant New Use Rule, EPA could set a specific 
threshold level for the content of the LCPFAC below which reporting 
would not be required (in percentage of the product composition for 
example). EPA requests comment both on how this threshold level could 
be determined, and on what such levels might be. Establishment of a 
threshold could be based on one or more of the following rationales: 
(1) Below the selected threshold level, there is no ``reasonable 
potential for exposure'' within the meaning of section 5(a)(5) (i.e., 
the risk of exposure is very low); and (2) below the selected threshold 
level, there is a ``reasonable potential for exposure'' (or, 
alternatively, there may be such a potential), but the potential does 
not ``justif[y] notification'' (i.e., potential for risk is very low in 
light of the low level of LCPFAC present in the surface coating). EPA 
is seeking comment on whether there would be reasonable potential for 
exposure under typical conditions of use of the article as contrasted 
with laboratory experiments designed to release the LCPFAC under 
laboratory conditions.
    Alternatively, EPA could establish or use specific criteria to 
determine whether or not the ``reasonable potential for exposure'' 
justifies notification. For example, EPA could receive from importers 
information on the level of LCPFAC in the product or in the surface 
coating, and determine the level is low enough to not meet the 
``reasonable potential for exposure'' notification requirement. EPA 
notes also that a person's exposure to LCPFAC could be impacted by 
whether or not the article itself is used as a stand-alone product or 
incorporated into another product, and as such receiving such 
information could also be of help to the Agency. Another consideration 
could be that EPA requests information on the method by which the 
LCPFAC is incorporated into the surface coating and whether that method 
changes the likelihood of release from the article. EPA seeks comment 
on the above discussion and on criteria that the Agency could use to 
determine whether or not the ``reasonable potential for exposure'' 
justifies notification. EPA seeks detailed input on these potential 
criteria, as well as other suggestions for criteria that could be 
implemented to help ensure that the notification is justified.
    We invite robust comment on these and other possible thresholds or 
criteria that could be implemented by EPA in a final rule.
    Finally, EPA notes that diverse importers of articles could be 
affected by this rule, and that some may be unfamiliar with the SNUR 
process and may not identify at the time of this rulemaking that they 
have an ongoing use of a LCPFAC. EPA requests comment on whether or not 
the Agency should include a safe harbor provision for importers of 
articles that can demonstrate their use was ongoing prior to the 
effective date of this rule. EPA requests that commenters discuss the 
text of section 5(a)(5) and how the discretion granted therein could be 
exercised to allow for a safe harbor provision. EPA also requests 
specific language that could be used in structuring such a safe harbor 
provision.

H. What should I consider as I prepare my comments for EPA?

    When submitting your comments, keep the following items in mind:
    1. Submitting CBI. It is EPA's policy to include all comments 
received in the public docket without change or further notice to the 
commenter and to make the comments available on-line at 
www.regulations.gov, including any personal information provided, 
unless a comment includes information claimed to be CBI or other 
information whose disclosure is restricted by statute. Do not submit 
this information to EPA through regulations.gov or email. Clearly mark 
the part or all of the information that is claimed to be CBI. For CBI 
information in a disk or CD ROM that you mail to EPA, mark the outside 
of the disk or CD ROM as CBI and then identify electronically within 
the disk or CD ROM the specific information that is claimed as CBI. In 
addition to one complete version of the comment that includes 
information claimed as CBI, a copy of the comment that does not contain 
the information claimed as CBI must be submitted for inclusion in the 
public docket. Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2, subpart B.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www2.epa.gov/dockets/commenting-epa-dockets#tips.

II. Chemical Substances Subject to This Proposed Rule

A. What chemicals are covered by this supplemental proposal?

    This supplemental proposal would modify the requirements for a 
subset of LCPFAC chemical substances at 40 CFR 721.10536 by making the 
exemption at 40 CFR 721.45(f) inapplicable for persons who import 
LCPFAC chemical substances listed in this unit and PFOA or its salts 
(see the second bulleted list of this unit) as part of an article in 
which these LCPFAC chemical substances have been applied as part of a 
surface coating. The subset of LCPFAC chemical substances also includes 
the salts and precursors of these perfluorinated carboxylates. EPA 
proposes to make the exemption inapplicable for import of these 
articles because there is reasonable potential for exposure to LCPFAC 
chemical substances, including PFOA, if these chemical substances are 
part of surface coatings on articles imported into the United States. 
As proposed in the 2015 SNUR NPRM, the article exemption

[[Page 12483]]

would still apply to LCPFAC chemical substances not listed in this 
unit, with the exception of the import of carpets, for which the import 
exemption is already inapplicable (78 FR 62443; October 22, 2013) (FRL-
9397-1). The other provision of 40 CFR 721.45(f), respecting processing 
a chemical substance as part of an article, remains applicable. These 
LCPFAC chemical substances are:
 Perfluorooctyl iodide (CAS Registry No. (CASRN) 507-63-1; TSCA 
Chemical Inventory Name: Octane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-
heptadecafluoro-8-iodo-)
 Tetrahydroperfluoro-1-decanol (CASRN 678-39-7; TSCA Chemical 
Inventory Name: 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
heptadecafluoro-)
 Perfluoro-1-dodecanol (CASRN 865-86-1; TSCA Chemical Inventory 
Name: 1-Dodecanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,12-
heneicosafluoro-)
 Perfluorodecyl iodide (CASRN 2043-53-0; TSCA Chemical 
Inventory Name: Decane, 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-
heptadecafluoro-10- iodo-)
 1,1,2,2-Tetrahydroperfluorododecyl iodide (CASRN 2043-54-1; 
TSCA Chemical Inventory Name: Dodecane, 
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10, 10-heneicosafluoro-12-iodo-)
 Perfluorodecylethyl acrylate (CASRN 17741-60-5; TSCA Chemical 
Inventory Name: 2-Propenoic acid, 
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,12-heneicosafluorododecyl 
ester)
 1,1,2,2-Tetrahydroperfluorodecyl acrylate (CASRN 27905-45-9; 
TSCA Chemical Inventory Name: 2-Propenoic acid, 
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl ester)
 1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12-
Pentacosafluoro-14-iodotetradecane (CASRN 30046-31-2; TSCA Chemical 
Inventory Name: Tetradecane, 
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12 
pentacosafluoro-14-iodo-)
 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,14-
Pentacosafluorotetradecan-1-ol (CASRN 39239-77-5; TSCA Chemical 
Inventory Name: 1-Tetradecanol, 
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,14-
pentacosafluoro-)
 
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,16
-Nonacosafluorohexadecan-1-ol (CASRN 60699-51-6; TSCA Chemical 
Inventory Name: 1-Hexadecanol, 
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,15,15,16,16,16
-nonacosafluoro-)
 
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14-
Nonacosafluoro-16-iodohexadecane (CASRN 65510-55-6; TSCA Chemical 
Inventory Name: Hexadecane, 
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14-
nonacosafluoro-16-iodo-)
 Sodium;2-methylpropane-1-sulfonate (CASRN 68187-47-3; TSCA 
Chemical Inventory Name: 1-Propanesulfonic acid, 2-methyl-, 2-[[1-oxo-
3-[(.gamma.-.omega.-perfluoro- C4-16-alkyl)thio]propyl]amino] derivs., 
sodium salts)
 1,1,2,2-Tetrahydroperfluoroalkyl (C8-C14) alcohol (CASRN 
68391-08-2; TSCA Chemical Inventory Name: Alcohols, C8-14, 
.gamma.-.omega.-perfluoro)
 Thiols, C8-20, gamma-omega-perfluoro, telomers with acrylamide 
(CASRN 70969-47-0; TSCA Chemical Inventory Name: Thiols, C8-20, 
.gamma.-.omega.-perfluoro, telomers with acrylamide)
 Silicic acid (H4SiO4), sodium salt 
(1:2), reaction products with chlorotrimethylsilane and 
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoro-1-decanol (CASRN 
125476-71-3; TSCA Chemical Inventory Name: Silicic acid 
(H4SiO4), sodium salt (1:2), reaction products 
with chlorotrimethylsilane and 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
heptadecafluoro-1-decanol)
 Thiols, C4-20, gamma-omega-perfluoro, telomers with acrylamide 
and acrylic acid, sodium salts) (CASRN 1078712-88-5; TSCA Chemical 
Inventory Name: Thiols, C4-20, .gamma.-.omega.-perfluoro, telomers with 
acrylamide and acrylic acid, sodium salts)
 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-
(2-((gamma-omega-perfluoro-C4-20-alkyl)thio)acetyl) derivs., inner 
salts (CASRN 1078715-61-3; TSCA Chemical Inventory Name: 1-
Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-[2-
[(.gamma.-.omega.-perfluoro-C4-20-a lkyl)thio]acetyl] derivs., inner 
salts)
 Polyfluoroalkyl betaine (generic) (CASRN is CBI; EPA Accession 
No. 71217; TSCA Chemical Inventory Name: Polyfluoroalkyl betaine 
(PROVISIONAL))
 Modified fluoroalkyl urethane (generic) (CASRN is CBI; EPA 
Accession No. 89419; TSCA Chemical Inventory Name: Modified fluoroalkyl 
urethane (PROVISIONAL))
 Perfluorinated polyamine (generic) (CASRN is CBI; EPA 
Accession No. 274147; TSCA Chemical Inventory Name: Perfluorinated 
polyamine (PROVISIONAL))
    The term LCPFAC refers to the long-chain category of perfluoroalkyl 
carboxylate chemical substances with perfluorinated carbon chain 
lengths equal to or greater than seven carbons and less than or equal 
to 20 carbons. The category of LCPFAC chemical substances also includes 
the salts and precursors of these perfluorinated carboxylates. See Unit 
II.A. of the proposed rule (Ref. 1) for further discussion of the 
LCPFAC category. In addition to the subset of LCPFAC chemical 
substances identified in the list above, PFOA and its salts would be 
subject to the proposal. PFOA and its salts are considered LCPFAC 
chemical substances. PFOA and examples of PFOA salts with CASRNs and 
chemical names are as follows:
 Pentadecafluorooctanoyl fluoride (CASRN 335-66-0; TSCA 
Chemical Inventory Name: Octanoyl fluoride, 
2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-pentadecafluoro-)
 Perfluorooctanoic acid (CASRN 335-67-1; TSCA Chemical 
Inventory Name: Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro- (PFOA))
 Silver perfluorooctanoate (CASRN 335-93-3; TSCA Chemical 
Inventory Name: Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro-, silver (+) salt (1:1))
 Sodium perfluorooctanoate (CASRN 335-95-5; TSCA Chemical 
Inventory Name: Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro-, sodium salt (1:1))
 Potassium perfluorooctanoate (CASRN 2395-00-8; TSCA Chemical 
Inventory Name: Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro-, potassium salt (1:1))
 Ammonium perfluorooctanoate (CASRN 3825-26-1; TSCA Chemical 
Inventory Name: Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
pentadecafluoro-, ammonium salt (1:1) (APFO)

B. What are the uses and production volumes of LCPFAC chemical 
substances?

    PFOA, a member of the LCPFAC category, is a synthetic (man-made) 
chemical that does not occur naturally in the environment. The ammonium 
salt of PFOA was manufactured in U.S. for use primarily as an aqueous 
dispersion agent in the manufacture of fluoropolymers. Chemical Data

[[Page 12484]]

Reporting (CDR) rule requires manufacturers (including importers) to 
report for PFOA if they meet 2,500 pounds production volume threshold 
at a single site. The last time PFOA manufacture was reported to EPA as 
part of this collection effort was for the 2016 reporting period. PFOA 
can also be created unintentionally by the degradation of some 
fluorotelomers, which are not manufactured using PFOA but could degrade 
to PFOA. Fluorotelomers are used to make polymers that impart soil, 
stain, grease, and water resistance to coated articles. Some 
fluorotelomer based products are also used as high-performance 
surfactants in products where an even flow is essential, such as 
paints, coatings, cleaning products, and fire-fighting foams for use on 
liquid fuel fires (Ref. 3).
    Through the 2010/2015 PFOA Stewardship Program, a voluntary risk 
reduction program, eight major manufacturers and processors of LCPFAC 
chemical substances committed to voluntarily work toward a phase-out of 
LCPFAC chemical substances (Ref. 4). All participating companies have 
met the PFOA Stewardship Program goals and have ceased the manufacture 
(including import) of the chemical substances listed in Tables 1 and 2 
of this unit. As such, the reduced supply of long-chain perfluorinated 
chemicals has led industries to transition to replacement chemical 
substances for many uses, as noted in both public comments and industry 
communication. However, there are still a number of ongoing uses of 
these chemical substances by companies not participating in the PFOA 
Stewardship Program. EPA became aware of these uses through public 
comments identifying several ongoing uses. In the final rule, EPA will 
recognize and exclude from the significant new uses any confirmed 
ongoing activities for these chemicals. Ongoing uses identified by EPA 
are not significant new uses of LCPFAC chemical substances and 
therefore would not be subject to this rule and would not require a 
significant new use notice submission to the Agency.
    The accompanying economic analysis for this supplemental proposed 
rule (Ref. 2) details which chemicals listed in Tables 1 and 2 of this 
unit were reported under the CDR rule (40 CFR 711) as manufactured 
(including imported) for 2015, the final year of the Stewardship 
Program (see Exhibits 2-1, 2-2, and 2-3 of the Economic Analysis). The 
production volumes have been withheld to protect confidential business 
information.

C. What are the potential health effects of LCPFAC chemical substances?

    To date, PFOA has LCPFACs have been linked to a number of health 
effects, including thyroid disease and impacts on reproductive function 
(Refs. 5 and 6). PFOA and its salts, which are considered LCPFAC 
chemical substances, have been the primary focus of studies related to 
LCPFAC class of chemical substances. PFOA is persistent, widely present 
in humans and the environment, has a half-life in humans of 2.3-3.8 
years, and can cause adverse effects in laboratory animals, including 
cancer and developmental and systemic toxicity (Refs. 3, 7, 8, 9, and 
10). Human epidemiology data report associations between PFOA exposure 
and high cholesterol, increased liver enzymes, decreased vaccination 
response, thyroid disorders, pregnancy-induced hypertension and 
preeclampsia, and cancer (testicular and kidney) (Ref. 11).

III. Rationale and Objectives

A. Rationale

    This supplemental proposal presents the basis for the reasonable 
potential for exposure to LCPFAC chemical substances from this category 
of articles for purposes of TSCA section 5(a)(5). LCPFAC chemical 
substances have been found in the blood of the general human 
population, as well as in wildlife, indicating that exposure to these 
chemical substances is widespread (Ref. 3, 12, and 13). Multiple 
pathways of exposure, including through drinking water, food, house 
dust, and release from treated articles are possible (Ref. 14).
    In the absence of a regulation, manufacture or processing for the 
significant new uses proposed on January 21, 2015 (Ref. 1), may begin 
at any time, without prior notice to EPA. As explained in the January 
21, 2015, proposal (Ref. 1), EPA is concerned that commencement of the 
manufacture (including import) or processing for any new uses, 
including resumption of past uses, of LCPFAC chemical substances could 
increase the magnitude and duration of exposure to humans.
    Consistent with EPA's past practice for issuing SNURs under TSCA 
section 5(a)(2), EPA's decision to propose a SNUR for a particular 
chemical is not based on an extensive evaluation of the hazard, 
exposure, or potential risk associated with that use. Rather, the 
existence of a SNUR requires a notice, upon receipt of which EPA would 
conduct an assessment. If a person decides to begin importing any of 
these chemicals for a significant new use, the notice to EPA allows the 
Agency to evaluate the use according to the specific parameters and 
circumstances surrounding the conditions of use.
    In most cases, LCPFAC chemical substances are not incorporated into 
the article and bound to the article matrix but are rather added or 
applied as a coating or as part of coating aid. Surface coatings are 
subject to mechanical and/or chemical or photolytic stress, which can 
lead to degradation of the coating layer, depending on the 
circumstances (e.g., depending upon the stressor and the type of 
coating matrix). As an unbound, unincorporated component of a surface 
coating (Refs. 15 and 16), LCPFAC chemical substances can thereby be 
released from the coating as a result of this degradation of the 
coating layer. Additionally, because LCPFAC chemical substances used in 
this category of articles are coating the surface, if the underlying 
substrate of the article is degraded and released, the LCPFAC surface 
coating could be released at the same time.
    Rather than making the article exemption inapplicable for any 
article, as was proposed in the January 21, 2015, proposal (Ref. 1), 
this action proposes to make a finding under TSCA section 5(a)(5) and 
make the article exemption at 40 CFR 721.45(f) inapplicable for persons 
importing the category of articles that contain certain LCPFAC chemical 
substances as part of a surface coating for a non-ongoing use. EPA 
defines ``articles where certain LCPFAC chemical substances are part of 
surface coating on articles'' as the category of articles subject to 
this rule, based on the reasonable potential for exposure as shown 
through research on LCPFAC chemical substances. This category of 
articles is expected to exhibit reasonable potential for exposure to 
LCPFAC chemical substances, as elaborated herein. EPA is not making a 
finding on the reasonable potential for exposure from articles that do 
not contain LCPFAC chemical substances as a surface coating.
i. Reasonable Potential for Exposure of LCPFAC From Surface Coatings
    A coating is a material applied in a thin layer to a surface as a 
protective, decorative, or functional film. This term often refers to 
paints such as lacquers or enamels, but also refers to films applied to 
other materials including, but are not limited to, paints, varnishes, 
sealants, adhesives, inks, maskants, and temporary protective coatings. 
LCPFAC chemical substances have been used in surface coatings for 
numerous applications given their hydrophobic and lipophobic 
properties. Examples of

[[Page 12485]]

LCPFAC coating applications in articles are stain- and water-repellent 
fabrics and nonstick products (e.g., coatings for cookware) (Ref. 3).
    The release of LCPFAC chemical substances from coatings on articles 
has been well-documented in the scientific literature. LCPFAC chemical 
substances can be released continuously over years from treated 
jackets, furniture, and carpets into the air due to volatilization 
(Refs. 17, 18, and 19) and due to degradation of commercial LCPFAC 
coatings by simple abiotic reaction with water (Ref. 20). Stone and 
tile sealants have been shown to contain extractable amounts of LCPFAC 
chemical substances and, for homes without carpeting, could be an 
indoor source of these chemical substances (Ref. 21).
    Given the reasonable potential for exposure to LCPFAC chemical 
substances from articles that have LCPFAC chemical substances as part 
of a surface coating, EPA is proposing to require notification for the 
import of articles that have LCPFAC chemical substances as part of a 
surface coating. As noted in Section 1F, EPA is also seeking robust 
comment on implementing a de minimis threshold, an alternative 
threshold, or other criteria to assist in determining whether the 
reasonable potential for exposure justifies notification to EPA. EPA is 
also seeking comment on a safe harbor provision.
    Articles that could potentially have LCPFAC chemical substances as 
part of a surface coating include, but are not limited to: Furniture, 
medical garments, safety equipment, outdoor apparel or equipment, 
automobile components, aerospace components, electronics, heavy 
machinery, and household appliances. EPA cites these studies (Refs. 17, 
18, 19, 20, and 21) to support the Agency's conclusion that there is 
reasonable potential for exposure from the category of articles that 
contain certain LCPFAC chemical substances as part of a surface 
coating.
ii. Proposed Finding
    Based on these considerations, EPA is proposing to make the TSCA 
section 5(a)(5) finding and make inapplicable the exemption at 40 CFR 
721.45(f) for persons who import any of a defined set of LCPFAC 
chemical substances as part of an article where LCPFAC chemical 
substances have been applied as part of a surface coating for a non-
ongoing use. The defined subset are the chemical substances phased out 
through the 2010/2015 PFOA Stewardship Program, shown in Table 1 and 
Table 2 of Unit II.
    The article exemption at 40 CFR 721.45(f) is based on an assumption 
that people and the environment will generally not be exposed to 
chemical substances in articles (Ref. 22). However, when added to the 
surface coating of an article, LCPFAC can be released over time with 
use (Refs. 3 and 20). Studies on the degradation of fluorotelomer-based 
polymers show that these polymers are subject to hydrolysis, photolysis 
and biodegradation, with half-lives of a few days to hundreds of years 
(Ref. 23). In addition, research by EPA on degradation of 
fluorotelomers and fluoropolymers has shown that some urethanes and 
acrylates biodegrade; however, half-lives and kinetics are not yet 
well-defined (Ref. 16). These studies have shown that the 
perfluorinated portion of some polymers is released as the polymer is 
degraded by microbial or abiotic processes to form telomer alcohols or 
other intermediates and that they eventually form LCPFAC. Based on this 
understanding, upon receipt of a SNUN, EPA intends to evaluate the 
potential risk of exposure to human health and the environment for any 
intended significant new use of LCPFAC chemical substances (including 
as part of a surface coating of an article).
    Given that the release of LCPFAC chemical substances from surface 
coatings on articles has been shown to occur and that these releases 
can be expected to result in exposure to the users of articles, EPA has 
reason to anticipate that importing articles that have certain LCPFAC 
chemical substances as part of a surface coating would create the 
potential for exposure to these LCPFAC chemical substances, and that 
EPA should have an opportunity to review the intended use before such 
use could occur. Therefore, EPA affirmatively finds under TSCA section 
5(a)(5) that notification for import is justified by the reasonable 
potential for exposure to certain LCPFAC chemical substances when part 
of surface coatings for the articles identified in this SNUR. Existence 
of the SNUR triggers the submission of a SNUN, thereby allowing EPA to 
evaluate potential uses (before those uses would begin) whether in the 
form of an article, or not, for any hazards, exposures and risks that 
might exist.
    A person who imports any of the chemical substances identified in 
this supplemental proposed SNUR for a significant new use as part of a 
surface coating on an article would be subject to the significant new 
use notification requirements. No person would be able to begin 
importing, as part of a surface coating for an article, any of the 
LCPFAC chemical substances identified in this supplemental proposed 
SNUR, for a significant new use without first submitting a SNUN to EPA.

B. Objectives

    Based on the considerations in Unit III.A., EPA wants to achieve 
the following objectives with regard to the significant new uses of 
LCPFAC chemical substances that are designated in the January 21, 2015, 
proposal (Ref. 1), including the articles identified in this 
supplemental proposal:
    1. EPA would receive notice of any person's intent to import the 
chemical substances for the described significant new use before that 
activity begins.
    2. EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins importing the 
chemical substances for the described significant new use.
    3. EPA would be able to either determine that the significant new 
use is not likely to present an unreasonable risk, or to take necessary 
regulatory action associated with any other determination, before the 
described significant new use of the chemical substance occurs.

IV. Economic Analysis

A. SNUNs

    EPA has evaluated the potential costs of establishing SNUR 
reporting requirements for potential importers of the chemical 
substance included in this supplemental proposal in surface coatings of 
articles (Ref. 2). In the event that a SNUN is submitted, average costs 
are estimated at approximately $23,000 per SNUN submission for large 
business submitters and about $10,000 for small business submitters. 
These estimates include the cost to prepare and submit the SNUN 
(averaging about $7,300), and the payment of a user fee. Businesses 
that submit a SNUN would be subject to either a $16,000 user fee 
required by 40 CFR 700.45(c)(2)(ii), or, if they are a small business, 
a reduced user fee of $2,800 (40 CFR 700.45(c)(1)(ii)). Businesses that 
submit a SNUN are also estimated to incur average costs of $63 for rule 
familiarization. First time submitters will incur an average cost of 
$123 for CDX registration and associated activities. Companies 
importing articles containing LCPFAC chemical substances as part of a 
surface coating will incur an average cost of $79 for notifying their 
customers of SNUR regulatory activities. EPA's complete economic 
analysis is available in the public docket for this rule (Ref. 2).
    In making inapplicable the exemption relating to persons who import 
certain

[[Page 12486]]

chemical substances as part of the surface coating of an article, this 
action may affect firms that plan to import or process types of 
articles that may contain the subject chemical substance in a surface 
coating. This is because while some firms have an understanding of the 
contents of the articles they import or process other firms do not. EPA 
acknowledges that importers and processors of articles may have varying 
levels of knowledge about the chemical content of the articles that 
they import or process. These parties may need to become familiar with 
the requirements of the rule. And while not required by the SNUR, these 
parties may take additional steps to determine whether the subject 
chemical substances are part of the articles that they are considering 
for import or processing. This determination may involve activities 
such as gathering information from suppliers along the supply chain, 
and/or testing samples of the article itself. Costs vary across the 
activities chosen and the extent of familiarity a firm has regarding 
the articles it imports or processes. Cost ranges are presented in 
Understanding the Costs Associated with Eliminating Exemptions for 
Articles in SNURs (Ref. 24). Based on available information, EPA 
believes that article importers or processors that choose to 
investigate their products would incur costs at the lower end of the 
ranges presented in the Economic Analysis. For those companies choosing 
to undertake actions to assess the composition of the articles they 
import or process, EPA expects that importers would take actions that 
are commensurate with the company's perceived likelihood that a 
chemical substance might be a part of an article for the significant 
new uses identified in Units II. and III., and the resources it has 
available. Example activities and their costs are provided in the 
accompanying Economic Analysis of this supplemental proposal (Ref. 2).

B. Export Notification

    Under TSCA section 12(b) and the implementing regulations at 40 CFR 
part 707, subpart D, exporters must notify EPA if they export or intend 
to export a chemical substance or mixture for which, among other 
things, a rule has been proposed or promulgated under TSCA section 5. 
For persons exporting a substance that is the subject of a SNUR, a one-
time notice to EPA must be provided for the first export or intended 
export to a particular country. The total costs of export notification 
will vary by chemical, depending on the number of required 
notifications (i.e., the number of countries to which the chemical is 
exported).

V. Scientific Standards, Evidence, and Available Information

    EPA has used scientific information, technical procedures, 
measures, methods, protocols, methodologies, and models consistent with 
the best available science, as applicable. These information sources 
supply information relevant to whether a particular use would be a 
significant new use, based on relevant factors including those listed 
under TSCA section 5(a)(2). Consistent with EPA's past practice for 
issuing SNURs under TSCA section 5(a)(2), EPA's decision to promulgate 
a SNUR for a particular chemical use need not be based on an extensive 
evaluation of the hazard, exposure, or potential risk associated with 
that use; as such, the January 2015 proposed rule (Ref. 1) and this 
supplemental proposal are not based on an evaluation of expected risks.
    The clarity and completeness of the data, assumptions, methods, 
quality assurance, and analyses employed in EPA's decision are 
documented, as applicable and to the extent necessary for purposes of 
the January 2015 proposed rule and this supplemental proposal, in Unit 
II. and in the references cited throughout the two preambles. 
Considering the extent to which the various information, procedures, 
measures, methods, protocols, methodologies or models used in EPA's 
decision have been subject to independent verification or peer review, 
EPA believes that their use is appropriate in this rule. EPA 
recognizes, based on the available information, that there is 
variability and uncertainty in whether any particular significant new 
use would actually present an unreasonable risk. For precisely this 
reason, EPA is proposing to require notice and review for these uses at 
such time as they are known more definitely.

VI. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl 
Sulfonate Chemical Substances; Significant New Use Rule. Proposed 
Rule. Federal Register. 80 FR 2885, January 21, 2015 (FRL-9915-63).
2. EPA. Economic Analysis of the Supplemental Proposal to the 
Significant New Use Rule for Perfluoroalkyl Sulfonates and Long-
Chain Perfluoroalkyl Carboxylate Chemical Substances. January 23, 
2020.
3. EPA. Long-Chain Perfluorinated Chemicals Action Plan. December 
30, 2009. Accessed at: https://www.epa.gov/sites/production/files/2016-01/documents/pfcs_action_plan1230_09.pdf.
4. EPA. Risk Management for Per- and Polyfluoroalkyl Substances 
(PFASs) under TSCA. Accessed at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-and-polyfluoroalkyl-substances-pfass.
5. Melzer, David, et al. ``Association between serum 
perfluorooctanoic acid (PFOA) and thyroid disease in the US National 
Health and Nutrition Examination Survey.'' Environmental health 
perspectives 118.5 (2010): 686-692.
6. Knox, Sarah S., et al. ``Implications of early menopause in women 
exposed to perfluorocarbons.'' The Journal of Clinical Endocrinology 
& Metabolism 96.6 (2011): 1747-1753.
7. Butt, Craig M., et al. ``Levels and trends of poly-and 
perfluorinated compounds in the arctic environment.'' Science of the 
Total Environment 408.15 (2010): 2936-2965.
8. Houde, Magali, et al. ``Biological monitoring of polyfluoroalkyl 
substances: a review.'' Environmental Science & Technology 40.11 
(2006): 3463-3473.
9. Calafat, Antonia M., et al. ``Polyfluoroalkyl chemicals in the US 
population: data from the National Health and Nutrition Examination 
Survey (NHANES) 2003-2004 and comparisons with NHANES 1999-2000.'' 
Environmental Health Perspectives 115.11 (2007): 1596.
10. Lau, Christopher, et al. ``Perfluoroalkyl acids: a review of 
monitoring and toxicological findings.'' Toxicological Sciences 99.2 
(2007): 366-394.
11. EPA. Health Effects Support Document for Perfluorooctanoic Acid 
(PFOA). EPA 822-R-16-003. May 2016.
12. EPA. Perfluoroalkyl Sulfonates; Significant New Use Rule; Final 
Rule. Federal Register. 67 FR 11008, March 11, 2002 (FRL-6823-6).
13. 3M Company. The Science of Organic Fluorochemistry. St. Paul, 
Minnesota, February 5, 1999.
14. Strynar, Mark J., and Andrew B. Lindstrom. ``Perfluorinated 
compounds in house dust from Ohio and North Carolina, USA.'' 
Environmental Science & Technology 42.10 (2008): 3751-3756.
15. Bohnet, Matthias. Ulmann's Encyclopedia of Industrial Chemistry. 
Wiley-Vch, 2003.
16. Plastics Industry Association. Guide to the Safe Handling of 
Fluoropolymer Resins. Fifth Addition. 2018.
17. Knepper, Thomas P., et al. ``Understanding the exposure pathways

[[Page 12487]]

of per-and polyfluoralkyl substances (PFASs) via use of PFASs-
containing products-risk estimation for man and environment.'' Texte 
47 (2014): 2014.
18. Gremmel, Christoph, et al. ``Systematic determination of 
perfluoroalkyl and polyfluoroalkyl substances (PFASs) in outdoor 
jackets.'' Chemosphere 160 (2016): 173-180.
19. Liu, Xiaoyu, et al. ``Determination of fluorotelomer alcohols in 
selected consumer products and preliminary investigation of their 
fate in the indoor environment.'' Chemosphere 129 (2015): 81-86.
20. Washington, J.W., T.M. Jenkins. 2015. Abiotic hydrolysis of 
fluorotelomer polymers as a source of perfluorocarboxylates at the 
global scale. Environmental Science & Technology. 49. 14129-14135.
21. Guo, Zhishi, et al. ``Perfluorocarboxylic acid content in 116 
articles of commerce.'' Research Triangle Park, NC: US Environmental 
Protection Agency (2009).
22. EPA. Significant New Uses of Chemical Substances; Certain 
Chemicals; Final Rule. Federal Register. 49 FR 35014, September 5, 
1984 (FRL-2541-8).
23. Washington, John W., et al. ``Decades-scale degradation of 
commercial, side-chain, fluorotelomer-based polymers in soils and 
water.'' Environmental science & technology 49.2 (2015): 915-923.
24. U.S. EPA. Understanding the Costs Associated with Eliminating 
Exemptions for Articles in SNURs. May 1, 2013.

VII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    The Office of Management and Budget (OMB) designated this to be a 
significant regulatory action and it was submitted to OMB for review 
under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 
(76 FR 3821, January 21, 2011). Any changes made in response to OMB 
recommendations have been documented in the docket for this action as 
required by section 6(a)(3)(E) of Executive Order 12866.
    EPA prepared an economic analysis of the potential costs and 
benefits associated with this action. A copy of the economic analysis, 
entitled ``Economic Analysis of the Supplemental Proposal to the 
Significant New Use Rule for Perfluoroalkyl Sulfonates and Long-Chain 
Perfluoroalkyl Carboxylate Chemical Substances'' (Ref. 2), is available 
in the docket and is briefly summarized in Unit IV.

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

    This action is expected to be subject to the requirements for 
regulatory actions specified in Executive Order 13771 (82 FR 9339, 
February 3, 2017). EPA prepared an analysis of the estimated costs and 
benefits associated with this action (Ref. 2), which is available in 
the docket and is summarized in Unit I.E.

C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden 
under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 
1320.3(b). The information collection activities associated with 
existing chemical SNURs are already approved under OMB control number 
2070-0038 (EPA ICR No. 1188); and the information collection activities 
associated with export notifications are already approved under OMB 
control number 2070-0030 (EPA ICR No. 0795). If an entity were to 
submit a SNUN to the Agency, the annual burden is estimated to be less 
than 100 hours per response, and the estimated burden for export 
notifications is less than 1.5 hours per notification. In both cases, 
burden is estimated to be reduced for submitters who have already 
registered to use the electronic submission system.
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information that requires OMB approval 
under the PRA, unless it has been approved by OMB and displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in Title 40 of the CFR, after appearing in the Federal 
Register, are listed in 40 CFR, part 9, and included on the related 
collection instrument, or form, as applicable.

D. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I 
certify that promulgation of this SNUR would not have a significant 
economic impact on a substantial number of small entities. The 
rationale supporting this conclusion is as follows.
    A SNUR applies to any person (including small or large entities) 
who intends to engage in any activity described in the rule as a 
``significant new use.'' By definition of the word ``new'' and based on 
all information currently available to EPA, it appears that no small or 
large entities presently engage in such activities. Since this SNUR 
will require a person who intends to engage in such activity in the 
future to first notify EPA by submitting a SNUN, no economic impact 
will occur unless someone files a SNUN to pursue a significant new use 
in the future or forgoes profits by avoiding or delaying the 
significant new use. Although some small entities may decide to conduct 
such activities in the future, EPA cannot presently determine how many, 
if any, there may be. However, EPA's experience to date is that, in 
response to the promulgation of SNURs covering over 1,000 chemical 
substances, the Agency receives only a handful of notices per year. 
During the six-year period from 2005-2010, only three submitters self-
identified as small in their SNUN submission (Ref. 2). Based on this, 
EPA believes that few SNUN submissions will occur as a result of the 
rule. EPA believes the cost of submitting a SNUN, $10,000 for small 
business submitters, is relatively small compared to the cost of 
developing and marketing a chemical new to a firm or marketing a new 
use of the chemical and that the requirement to submit a SNUN generally 
does not have a significant economic impact.
    Therefore, EPA believes that the potential economic impact of 
complying with this proposed SNUR is not expected to be significant or 
adversely impact a substantial number of small entities. In a SNUR that 
published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4), 
the Agency presented its general determination that proposed and final 
SNURs are not expected to have a significant economic impact on a 
substantial number of small entities.

E. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reason to believe that any 
State, local, or Tribal government would be impacted by this 
rulemaking. As such, the requirements of sections 202, 203, 204, or 205 
of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.

F. Executive Order 13132: Federalism

    This action will not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will 
not have substantial direct effect on States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government.

[[Page 12488]]

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will 
not have any effect on tribal governments, on the relationship between 
the Federal Government and the Indian tribes, or on the distribution of 
power and responsibilities between the Federal Government and Indian 
tribes.

H. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because this action does not address environmental 
health or safety risks, and EPA interprets Executive Order 13045 as 
applying only to those regulatory actions that concern environmental 
health or safety risks that EPA has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of the Executive Order.

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

    This action is not a significant energy action as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not 
likely to have any effect on energy supply, distribution, or use.

J. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve any technical standards and is 
therefore not subject to considerations under section 12(d) of NTTAA, 
15 U.S.C.272 note.

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

    This action will not have disproportionately high and adverse human 
health or environmental effects on minority or low-income populations 
as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). 
This action does not affect the level of protection provided to human 
health or the environment.

List of Subjects in 40 CFR Part 721

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

    Dated: February 20, 2020.
Andrew R. Wheeler,
Administrator.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

0
2. Revise Sec.  721.10536 to read as follows:

Sec.  721.10536  Long-chain perfluoroalkyl carboxylate chemical 
substances.

    (a) Definitions. The definitions in Sec.  721.3 apply to this 
section. In addition, the following definition applies:
    Carpet means a finished fabric or similar product intended to be 
used as a floor covering. This definition excludes resilient floor 
coverings such as linoleum and vinyl tile.
    (b) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified in this paragraph, 
where 5 < n < 21 or 6 < m < 21, are subject to reporting under this 
section for the significant new uses described in paragraph (b)(4)(i) 
and (b)(4)(iv) of this section.
    (i) CF3(CF2)n-COO M where M, = 
H+ or any other group where a formal dissociation can be 
made.
    (ii) CF3(CF2)n-CH=CH2.
    (iii) CF3(CF2)n-C(=O)-X, where X 
is any chemical moiety.
    (iv) CF3(CF2)m-CH2-X, 
where X is any chemical moiety.
    (v) CF3(CF2)m-Y-X, where Y = non-
S, non-N heteroatom and where X is any chemical moiety.
    (2) The chemical substances listed in Table 1 of this paragraph are 
subject to reporting under this section for the significant new uses 
described in paragraph (b)(4)(ii) of this section.

        Table 1 to Paragraph (b)--LCPFAC Chemical Substances Subject to Reporting After December 31, 2015
----------------------------------------------------------------------------------------------------------------
                                                                     EPA
             Chemical name                  CAS registry  No.     accession      TSCA chemical inventory name
                                                 (CASRN)              No.
----------------------------------------------------------------------------------------------------------------
Perfluorooctyl iodide.................  507-63-1................        N/A  Octane,
                                                                              1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-
                                                                              heptadecafluoro-8-iodo-.
Tetrahydroperfluoro-1-decanol.........  678-39-7................        N/A  1-Decanol,
                                                                              3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,
                                                                              10-heptadecafluoro-.
Perfluoro-1-dodecanol.................  865-86-1................        N/A  1-Dodecanol,
                                                                              3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,
                                                                              11,11,12,12,12-heneicosafluoro-.
Perfluorodecyl iodide.................  2043-53-0...............        N/A  Decane,
                                                                              1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8-
                                                                              heptadecafluoro-10-iodo-.
1,1,2,2-Tetrahydroperfluorododecyl      2043-54-1...............        N/A  Dodecane,
 iodide.                                                                      1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,
                                                                              9,9,10 ,10-heneicosafluoro-12-iodo-
                                                                              .
Perfluorodecylethyl acrylate..........  17741-60-5..............        N/A  2-Propenoic acid,
                                                                              3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,
                                                                              11,11, 12,12,12-
                                                                              heneicosafluorododecyl ester.
1,1,2,2-Tetrahydroperfluorodecyl        27905-45-9..............        N/A  2-Propenoic acid,
 acrylate.                                                                    3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,
                                                                              10-heptadecafluorodecyl ester.
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,  30046-31-2..............        N/A  Tetradecane,
 10,10,11,11,12,12-Pentacosafluoro-14-                                        1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,
 iodotetradecane.                                                             9,9,10,10,11,11,12,12-
                                                                              pentacosafluoro-14-iodo-.
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,1  39239-77-5..............        N/A  1-Tetradecanol,
 1,12,12,13,13,14,14,14-                                                      3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,
 Pentacosafluorotetradecan-1-ol.                                              11,11,12,12,13,13,14,14,14-
                                                                              pentacosafluoro-.
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,1  60699-51-6..............        N/A  1-Hexadecanol,
 1,12,12,13,13,14,14,15,15,16,16,16-                                          3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,
 Nonacosafluorohexadecan-1-ol.                                                11,11,12,12,13,13,14,14,15,15,16,1
                                                                              6,16-nonacosafluoro-.
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,  65510-55-6..............        N/A  Hexadecane,
 10,10,11,11,12,12,13,13,14,14-                                               1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,
 Nonacosafluoro-16-iodohexadecane.                                            9,9,10,10,11,11,12,12,13,13,14,14-
                                                                              nonacosafluoro-16-iodo-.
Sodium;2-methylpropane-1-sulfonate....  68187-47-3..............        N/A  1-Propanesulfonic acid, 2-methyl-,
                                                                              2-[[1-oxo-3-[(.gamma.-.omega.-
                                                                              perfluoro- C4-16-
                                                                              alkyl)thio]propyl]amino] derivs.,
                                                                              sodium salts.
1,1,2,2-Tetrahydroperfluoroalkyl (C8-   68391-08-2..............        N/A  Alcohols, C8-14, .gamma.-.omega.-
 C14) alcohol.                                                                perfluoro.
Thiols, C8-20, gamma-omega-perfluoro,   70969-47-0..............        N/A  Thiols, C8-20, .gamma.-.omega.-
 telomers with acrylamide.                                                    perfluoro, telomers with
                                                                              acrylamide.
Silicic acid (H4SiO4), sodium salt      125476-71-3.............        N/A  Silicic acid (H4SiO4), sodium salt
 (1:2), reaction products with                                                (1:2), reaction products with
 chlorotrimethylsilane and                                                    chlorotrimethylsilane and
 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-                                        3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,
 heptadecafluoro-1-decanol.                                                   10-heptadecafluoro-1-decanol.
Thiols, C4-20, gamma-omega-perfluoro,   1078712-88-5............        N/A  Thiols, C4-20, .gamma.-.omega.-
 telomers with acrylamide and acrylic                                         perfluoro, telomers with
 acid, sodium salts).                                                         acrylamide and acrylic acid,
                                                                              sodium salts.
1-Propanaminium, 3-amino-N-             1078715-61-3............        N/A  1-Propanaminium, 3-amino-N-
 (carboxymethyl)-N,N-dimethyl-, N-(2-                                         (carboxymethyl)-N,N-dimethyl-, N-
 ((gamma-omega-perfluoro-C4-20-                                               [2-[(.gamma.-.omega.-perfluoro-C4-
 alkyl)thio)acetyl) derivs., inner                                            20-a lkyl)thio]acetyl] derivs.,
 salts.                                                                       inner salts.
Polyfluoroalkyl betaine (generic).....  CBI.....................      71217  Polyfluoroalkyl betaine
                                                                              (PROVISIONAL).

[[Page 12489]]

 
Modified fluoroalkyl urethane           CBI.....................      89419  Modified fluoroalkyl urethane
 (generic).                                                                   (PROVISIONAL).
Perfluorinated polyamine (generic)....  CBI.....................     274147  Perfluorinated polyamine
                                                                              (PROVISIONAL)
----------------------------------------------------------------------------------------------------------------

    (3) The chemical substances identified as perfluorooctanoic acid 
(PFOA) and its salts, including those listed in Table 2 of this 
paragraph, are subject to reporting under this section for the 
significant new uses described in paragraph (b)(4)(iii) of this 
section.

        Table 2 to Paragraph (b)--PFOA and Examples of Its Salts
------------------------------------------------------------------------
                                  CAS registry
          Chemical name                No.       TSCA chemical inventory
                                     (CASRN)              name
------------------------------------------------------------------------
Pentadecafluorooctanoyl fluoride      335-66-0  Octanoyl fluoride,
                                                 2,2,3,3,4,4,5,5,6,6,7,7
                                                 ,8,8,8-pentadecafluoro-
                                                 .
Perfluorooctanoic acid..........      335-67-1  Octanoic acid,
                                                 2,2,3,3,4,4,5,5,6,6,7,7
                                                 ,8,8,8-pentadecafluoro-
                                                 (PFOA).
Silver perfluorooctanoate.......      335-93-3  Octanoic acid,
                                                 2,2,3,3,4,4,5,5,6,6,7,7
                                                 ,8,8,8-pentadecafluoro-
                                                 , silver (+) salt
                                                 (1:1).
Sodium perfluorooctanoate.......      335-95-5  Octanoic acid,
                                                 2,2,3,3,4,4,5,5,6,6,7,7
                                                 ,8,8,8-pentadecafluoro-
                                                 , sodium salt (1:1).
Potassium perfluorooctanoate....     2395-00-8  Octanoic acid,
                                                 2,2,3,3,4,4,5,5,6,6,7,7
                                                 ,8,8,8-pentadecafluoro-
                                                 , potassium salt (1:1).
Ammonium perfluorooctanoate.....     3825-26-1  Octanoic acid,
                                                 2,2,3,3,4,4,5,5,6,6,7,7
                                                 ,8,8,8-pentadecafluoro-
                                                 , ammonium salt (1:1)
                                                 (APFO).
------------------------------------------------------------------------

    (4) Significant new uses:
    (i) The significant new use for chemical substances identified in 
paragraph (b)(1) of this section are: Manufacture (including import) or 
processing for use as part of carpets or to treat carpets (e.g., for 
use in the carpet aftercare market).
    (ii) The significant new use for chemical substances identified in 
paragraph (b)(2) of this section are: Manufacture (including import) or 
processing for any use after December 31, 2015.
    (iii) The significant new use for chemical substances identified in 
paragraph (b)(3) of this section are: Manufacture (including import) or 
processing for any use. Import of fluoropolymer dispersions and 
emulsions, and fluoropolymers as part of articles, containing chemical 
substances identified in paragraph (b)(3) of this section shall not be 
considered as a significant new use subject to reporting.
    (iv) The significant new use for chemical substances identified in 
paragraph (b)(1) of this section, except for those chemicals identified 
in Table 1 of paragraph (b)(2) of this section are: Manufacture 
(including import) or processing for any use other than that use 
already covered by paragraph (b)(4)(i) of this section.
    (c) Specific requirements. (1) Revocation of certain notification 
exemptions. With respect to imports of carpets, the provisions of Sec.  
721.45(f) do not apply to this section. With respect to imports of 
articles, the provisions of Sec.  721.45(f) also do not apply to a 
chemical substance identified in paragraphs (b)(2) or (b)(3) of this 
section when they are part of a surface coating of an article. A person 
who imports a chemical substance identified in paragraph (b)(1) of this 
section as part of a carpet or who imports a chemical substance 
identified in paragraphs (b)(2) or (b)(3) of this section as part of a 
surface coating on an article is not exempt from submitting a 
significant new use notice. The other provision of Sec.  721.45(f), 
respecting processing a chemical substance as part of an article, 
remains applicable.
    (2) [Reserved]

[FR Doc. 2020-03865 Filed 3-2-20; 8:45 am]
 BILLING CODE 6560-50-P