[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Proposed Rules]
[Pages 48924-48934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19952]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2012-0268; FRL-9358-7]
RIN 2070-AJ95


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is 
proposing to amend a significant new use rule (SNUR) for perfluoroalkyl 
sulfonate (PFAS) chemical substances to add PFAS chemical substances 
that have completed the TSCA new chemical review process but have not 
yet commenced production or import, and to designate (for all listed 
PFAS chemical substances) processing as a significant new use. EPA is 
also proposing a SNUR for long-chain perfluoroalkyl carboxylate 
(LCPFAC) chemical substances that would designate manufacturing, 
importing, or processing for use as part of carpets or for treating 
carpet (e.g., for use in the carpet aftercare market) as a significant 
new use. For this SNUR, EPA is also proposing to make the article 
exemption inapplicable to the import of LCPFAC chemical substances as 
part of carpets. Persons subject to these SNURs would be required to 
notify EPA at least 90 days before commencing any significant new use. 
The required notifications would provide EPA with the opportunity to 
evaluate the intended use and, if necessary, to prohibit or limit that 
activity before it occurs.

DATES: Comments must be received on or before October 15, 2012.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2012-0268, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     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: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID number EPA-HQ-OPPT-2012-0268. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the DCO's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2012-0268. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or 
email. The regulations.gov Web site is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an email 
comment directly to EPA without going through regulations.gov, your 
email address will be automatically captured and included as part of 
the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov; select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov web 
site to view the docket index or access available documents. Although 
listed in the index, some information is not publicly available, e.g., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available electronically at 
http://www.regulations.gov, or, if only available in hard copy, at the 
OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/
DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW., 
Washington, DC. The EPA/DC Public Reading Room hours of operation are 
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal 
holidays. The telephone number of the EPA/DC Public Reading Room is 
(202) 566-1744, and the telephone number for the OPPT Docket is (202) 
566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Katherine Sleasman, Chemical Control Division (7405M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
202-564-7716; 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. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or import any of the chemical substances listed in Table 4 of 
this unit.
    Potentially affected entities may include, but are not limited to:

[[Page 48925]]

     Manufacturers or importers of one or more of subject 
chemical substances (North American Industrial Classification System 
(NAICS) codes 325 and 324110); e.g., chemical manufacturing and 
petroleum refineries,
     Carpet and rug mills (NAICS code 314110),
     Fiber, yarn, and thread mills (NAICS code 31311),
     Home furnishing merchant wholesalers (NAICS code 423220), 
and
     Carpet and upholstery cleaning services (NAICS code 
561740).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in 40 CFR 721.5, 40 CFR 
721.9582, and proposed 40 CFR 721.10536. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult the technical person listed under FOR FURTHER INFORMATION 
CONTACT.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Persons 
who import any chemical substance governed by a final SNUR are subject 
to the TSCA section 13 (15 U.S.C. 2612) import certification 
requirements and the corresponding regulations at 19 CFR 12.118 through 
12.127; see also 19 CFR 127.28. Those persons must certify that the 
shipment of the chemical substance complies with all applicable rules 
and orders under TSCA, including any SNUR requirements. The EPA policy 
in support of import certification appears at 40 CFR part 707, subpart 
B. In addition, any persons who export or intend to export a chemical 
substance that is the subject of this proposed rule on or after 
September 14, 2012 are subject to the export notification provisions of 
TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must 
comply with the export notification requirements in 40 CFR part 707, 
subpart D.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM 
that you mail to EPA 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.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date, and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What action is the agency taking?

    Under section 5(a)(2) of TSCA, EPA is proposing to amend a SNUR at 
Sec.  721.9582 for PFAS chemical substances to add PFAS chemical 
substances that have completed the TSCA new chemical review process but 
have not yet commenced production or import, and to designate (for all 
listed PFAS chemical substances) processing as a significant new use. 
EPA is also proposing a SNUR for LCPFAC chemical substances that would 
designate manufacturing, importing, or processing for use as part of 
carpets or for treating carpet (e.g., for use in the carpet aftercare 
market) as a significant new use. For this SNUR, EPA is also proposing 
to make the article exemption at Sec.  721.45(f) inapplicable to 
persons who import LCPFAC chemical substances as part of carpets 
because if in the future LCPFAC are incorporated in carpets and then 
imported, exposure would increase. However, the article exemption at 
Sec.  721.45(f) would be in effect for persons who import LCPFAC 
chemical substances as part of other sorts of articles. The article 
exemption at Sec.  721.45(f) relating to persons who process chemical 
substances as part of an article would also be in effect, for both the 
PFAS SNUR and the LCPFAC SNUR. On December 30, 2009, EPA issued the 
``Long-Chain Perfluorinated Chemicals (PFCs) Action Plan'' (Ref. 1). 
Today's action is consistent with the purpose of that Action Plan. EPA 
is continuing to assess these chemicals to determine what other actions 
would be warranted.
    In this proposal, the term PFAS refers to a general category of 
perfluorinated sulfonate chemical substances of any chain length. The 
PFAS chemical substances for which EPA is proposing to modify an 
existing SNUR are currently listed in Sec.  721.9582 in paragraph 
(a)(1). The PFAS chemical substances that EPA is proposing to add to an 
existing SNUR would be added to this list. All of these chemical 
substances are collectively referred to in this proposed rule as 
perfluoroalkyl sulfonates, or PFAS chemical substances.
    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. The category of LCPFAC 
chemical substances also includes the salts and precursors of these 
perfluorinated carboxylates. See Unit IV.A for the specific definition 
of the LCPFAC category.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including those listed in TSCA section 5(a)(2). Once 
EPA determines that a use of a chemical substance is a significant new 
use, TSCA section 5(a)(1)(B) requires persons to submit a significant 
new use notice (SNUN) to EPA at least 90 days before they manufacture, 
import, or process the chemical substance for that use (15 U.S.C. 
2604(a)(1)(B)). As described in Unit II.C., the general SNUR provisions 
are found at 40 CFR part 721, subpart A.

[[Page 48926]]

C. Applicability of General Provisions

    General provisions for SNURs appear under 40 CFR part 721, subpart 
A. These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the final 
rule. However, EPA is proposing that the articles exemption at 40 CFR 
721.45(f) would not apply to imports of LCPFAC chemical substances as 
part of carpets under this proposed SNUR. As a result, persons subject 
to the provisions of this proposed rule would not be exempt from 
significant new use reporting if they import LCPFAC chemical substances 
as part of carpets. However, EPA is proposing that the articles 
exemption remain in effect for persons who process chemical substances 
as part of an article because, with respect to carpets, existing stocks 
may still contain LCPFAC substances. Provisions relating to user fees 
appear at 40 CFR part 700. According to 40 CFR 721.1(c), persons 
subject to SNURs must comply with the same notice requirements and EPA 
regulatory procedures as submitters of Premanufacture Notices (PMNs) 
under TSCA section 5(a)(1)(A). In particular, these requirements 
include the information submissions requirements of TSCA section 5(b) 
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA 
receives a SNUN, EPA may take regulatory action under TSCA section 
5(e), 5(f), 6 or 7 to control the activities on which it has received 
the SNUN. If EPA does not take action, EPA is required under TSCA 
section 5(g) to explain in the Federal Register its reasons for not 
taking action.
    Persons who export or intend to export a chemical substance 
identified in a 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. 
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 EPA policy in support of import certification 
appears at 40 CFR part 707, subpart B.

III. Overview of PFAS Chemical Substances

A. What PFAS chemical substances are subject to this proposed SNUR?

    The PFAS chemical substances for which EPA is proposing to add 
additional significant new uses are already listed in Sec.  721.9582 in 
paragraph (a)(1). The PFAS chemical substances that EPA is proposing to 
add to the existing PFAS SNUR are the subjects of PMN Case Numbers P-
83-0126, P-90-0110, P-94-1508, P-94-1509B, P-98-0809, P-99-0296, and P-
01-0035. The PMN submitters for these chemicals never commenced 
manufacturing or import of these chemicals. EPA considers that the 
commencement of manufacturing, import, or processing of these chemicals 
would thus significantly increase the magnitude and duration of 
exposure to humans and the environment. Given the structural similarity 
of these chemicals to the PFAS chemicals covered under 40 CFR 721.9582 
and EPA's health and environmental concerns associated with these 
chemicals, EPA has concluded any manufacturing, import, or processing 
for any use of these uncommenced PFAS chemicals would be a significant 
new use and therefore, action on these PFAS chemicals is warranted.
    All of these chemical substances are referred collectively in this 
proposed rule as perfluoroalkyl sulfonates, or PFAS chemical 
substances.

B. What action has the agency previously taken on other PFAS chemical 
substances?

    On October 18, 2000, EPA published in the Federal Register a 
proposed SNUR (65 FR 62319) (FRL-6745-5) to regulate perfluorooctyl 
sulfonate (PFOS). The structure and definition of the chemical 
substances affected by the proposed SNUR were described on page 62325, 
Unit IV.A. of that proposed rule. The final rule was published in the 
Federal Register on March 11, 2002 (67 FR 11008) (FRL-6823-6), for 13 
PFAS chemical substances (Ref. 2). In response to comments, EPA decided 
to use the generic term perfluoroalkyl sulfonates (PFAS) for this 
category of perfluorinated compounds, which includes those with eight 
carbons as well as those with higher and lower amounts of carbon and 
the term PFOS to represent only those chemical substances that have 
predominantly eight carbons. A supplemental proposed SNUR for 75 other 
similar PFAS chemical substances was published in the Federal Register 
on March 11, 2002 (67 FR 11014) (FRL-6823-7) (Ref. 3). EPA promulgated 
a final rule for these 75 PFAS chemical substances on December 9, 2002 
(67 FR 72854) (FRL-7279-1) (Ref. 4). On March 10, 2006 (71 FR 12311) 
(FRL-7740-6), EPA proposed to add 183 PFAS chemical substances to the 
SNUR at 40 CFR 721.9582, and published a final rule for these 183 PFAS 
chemical substances on October 9, 2007 (71 FR 12311) (FRL-8150-4) (Ref. 
5).

C. What are the uses and production levels of the PFAS chemical 
substances?

    The Agency previously determined that the 271 PFAS chemical 
substances identified in 40 CFR 721.9582(a)(1) were no longer being 
manufactured or imported for any use in the United States, other than 
the uses listed under Sec.  721.9582 (a)(3), (a)(4), and (a)(5) (67 FR 
72858 and 72 FR 57225). In addition, since those chemicals are no 
longer manufactured or imported other than for the listed uses, EPA 
concluded that those chemical substances are also no longer processed 
other than for those listed uses.
    PFAS chemical substances included in Sec.  721.9582 were previously 
used in a variety of products, which can be divided into three main use 
categories: Surface treatments, paper protection, and performance 
chemicals (Ref. 6). In the past, PFAS chemical substances in the 
performance chemicals category were used in a wide variety of 
specialized industrial, commercial, and consumer applications. Specific 
applications included fire fighting foams, mining and oil well 
surfactants, acid mist suppressants for metal plating and electronic 
etching baths, alkaline cleaners, floor polishes, inks, photographic 
film, denture cleaners, shampoos, chemical intermediates, coating 
additives, carpet spot cleaners, and as an insecticide in bait stations 
for ants (Ref. 7). In 2000, the domestic production volume of the PFAS 
chemical substances containing eight carbons for the performance 
chemicals use category was estimated to be approximately 1.5 million 
pounds (Ref. 16).
    PFAS chemical substances were also used for treating textiles, 
fabrics and carpet. These upholstery and fabric protectors were 
designed to protect rugs and carpets against soiling and restore their 
original look. Prior to 2003, these formulations were based on PFOS 
compounds, which contain eight perfluorinated carbons. After 2003, 
however, 3M, the primary manufacturer of these chemical substances, 
reformulated the product to be based on perfluorobutane sulfonate 
(PFBS) compounds containing four

[[Page 48927]]

perfluorinated carbons (Ref. 8). In addition to domestic manufacture, 
articles treated with these PFAS chemical substances are also imported. 
EPA is continuing to evaluate these uses and may determine that 
regulatory action may be appropriate in the future.
    The PFAS chemical substances that EPA is proposing to add to the 
existing PFAS SNUR are chemical substances that have completed the TSCA 
new chemical review process but have not yet commenced production or 
import. Any person who commences the manufacture or import of a new 
chemical substance for which that person previously submitted a section 
5(a) notice must submit a notice of commencement of manufacture or 
import (40 CFR 720.102). EPA has not received any notices of 
commencements for these chemical substances, and there is currently no 
production or import of these chemical substances. If commenced, these 
chemical substances could be used for the PFAS uses described above, 
significantly increasing the magnitude and duration of exposure to 
humans and the environment, constituting a significant new use.

D. What are the potential health effects of these chemicals and the 
potential sources and routes of exposures to these chemicals?

    PFAS chemical substances degrade ultimately to 
perfluoroalkylsulfonic acid (PFASA), which can exist in the anionic 
form under environmental conditions. Further degradation of PFASA is 
not observed under normal environmental conditions. PFASA is highly 
persistent in the environment and has a tendency to bioaccumulate 
(Refs. 8 and 9). PFASA can continue to be formed by any PFAS containing 
chemical substances introduced into the environment.
    Studies have found PFAS chemical substances containing five to 
fourteen carbons (C5-C14) in the blood of the general human population, 
as well as in wildlife, indicating that exposure to these chemical 
substances is widespread (Refs. 1, 2, and 10). The widespread presence 
of PFAS chemical substances in human blood samples nationwide suggests 
other pathways of exposure, possibly including the release of PFAS 
treated articles. EPA's Office of Research and Development (ORD) has 
conducted research on 116 articles of commerce documenting that PFCs 
contained in articles of commerce have the potential to be released 
from those articles and be transformed into PFAC (Ref. 1).
    Biological sampling has shown the presence of certain 
perfluoroalkyl compounds in fish and in fish-eating birds across the 
United States and in locations in Canada, Sweden, and the South Pacific 
(Ref. 2). The wide distribution of the chemical substances in high 
trophic levels is strongly suggestive of the potential for 
bioaccumulation and/or bioconcentration.
    Based on currently available information, EPA believes that while 
all PFAS chemical substances are expected to persist, the length of the 
perfluorinated chain may also have an effect on bioaccumulation and 
toxicity, which are also characteristics of concern for these chemical 
substances. PFAS chemical substances with longer carbon chain lengths 
may be of greater concern than those with shorter chain lengths (Refs. 
11, 12, and 13).
    The hazard assessment published by the Organization for Economic 
Cooperation and Development (OECD) (Ref. 15) concluded that 
perfluorooctyl sulfonates (PFOS) are persistent, bioaccumulative and 
toxic to mammalian species. While most studies to date have focused 
primarily on PFOS, structure-activity relationship analysis indicates 
that the results of those studies are applicable to the entire category 
of PFAS chemical substances, which includes PFOS. Available test data 
have raised concerns about their potential developmental, reproductive, 
and systemic toxicity (Refs. 1, 2, and 3).
    For a more detailed summary of background information (e.g., 
chemistry, environmental fate, exposure pathways, and health and 
environmental effects), as well as references pertaining to PFAS 
chemical substances, please refer to EPA's proposed SNURs on PFAS 
chemical substances issued in the Federal Register of October 18, 2000 
(65 FR 62319) (FRL-6745-5) (Ref. 16) and March 10, 2006 (71 FR 12311) 
(FRL-7740-6) (Ref. 17), and also refer to December 30, 2009 Long-Chain 
Perfluorinated Chemicals Action Plan (Ref. 1).

IV. Overview of LCPFAC Chemical Substances

A. What LCPFAC chemical substances are subject to this proposed SNUR?

    LCPFAC chemical substances are synthetic chemicals that do not 
occur naturally in the environment. The LCPFAC chemical substances are 
identified as follows, where n > 5 or m > 6:

1. CF3(CF2)n-COO\-\M where M = H\+\ 
or any other group where a formal dissociation can be made;
2. CF3(CF2)n-CH = CH2;
3. CF3(CF2)n-C(=O)-X where X is any 
chemical moiety;
4. CF3(CF2)m-CH2-X where 
X is any chemical moiety;
5. CF3(CF2)m-Y-X where Y = non-S, 
non-N hetero atom and where X is any chemical moiety; and
6. Structurally similar degradation products of any of the compounds 
in 2. through 5. above.

    This category definition of LCPFAC, based on the chemical 
structures above, refers to a large group of chemical substances 
containing perfluorooctanoic acid (PFOA) and its higher homologues. The 
category also includes the salts and precursors of these chemical 
substances. The precursors may be simple derivatives of PFOA and higher 
homologues or polymers that contain or may degrade to PFOA or higher 
homologues. These precursors include certain fluoropolymers and all 
fluorotelomers.

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

    Currently, DuPont is the sole manufacturer of PFOA in the United 
States. In addition, PFOA, except possibly as part of articles, is not 
imported into the United States with the exception of the product 
manufactured by DuPont facilities overseas. According to EPA's 2006 
Inventory Update Reporting database, the aggregated production volume 
of PFOA and ammonium perfluorooctanoate (APFO) was less than 500,000 
pounds for each. APFO is the ammonium salt of PFOA, which dissociates 
to PFOA in water (Ref. 1).
    Fluoropolymers such as polytetrafluoroethylene (PTFE), which may 
contain some PFAC contamination, or that use PFOA as an emulsion 
stabilizer in aqueous dispersions, are included in the LCPFAC 
definition and have a large U.S. market. The wire and cable industry is 
one of the largest segments of the fluoropolymer market, accounting for 
more than 35 percent of total U.S. fluoropolymer use. Apparel makes up 
about 10 percent of total fluoropolymer use, based on total reported 
production volume. Fluoropolymers are used in a wide variety of 
mechanical and industrial components, such as plastic gears, gaskets 
and sealants, pipes and tubing, O-rings, and many other products. Total 
U.S. demand for fluoropolymers in 2004 was between 50,000 and 100,000 
metric tons. The United States accounted for less than 25 percent of 
the world consumption of PTFE in 2007, and between 25 and 50 percent of 
the world consumption of other fluoropolymers. PTFE is the most 
commonly used fluoropolymer, and the United States

[[Page 48928]]

consumed less than 50,000 metric tons of PTFE in 2008 (Ref. 1).
    Fluorotelomers, oligomers of tetrafluoroethylene, are relatively 
small functionalized molecules used to make polymers. World-wide 
production of fluorotelomer-based polymers (FTBP), was estimated at 20 
million pounds in 2006. Fluorotelomer monomers and FTBP are included in 
the LCPFAC category definition as potential LCPFAC precursors. The 
United States accounts for more than 50 percent of world-wide 
fluorotelomer/FTPB production. Textiles and apparel account for 
approximately 50 percent of the volume, with carpet and carpet care 
products accounting for the next largest share in consumer product 
uses. Polymeric coatings, including those for paper products, are the 
third largest category of consumer product uses (Ref. 1). Articles 
tested and found to contain the highest levels of PFAC were carpet and 
carpet treatment products, various types of apparel, home textiles, 
thread sealant tape, floor wax and other sealants, and food contact 
paper and paper coatings.
    LCPFAC chemical substances, including FTBP, were used in the 
textile market because of their thermo-stability, ability to adapt to a 
variety of surface characteristics, low refractive indexes, low 
dielectric constants, and high chemical stability. FTBP are used as 
soil retardants and stain repellents in carpets. FTBP are used to treat 
textiles which cannot be laundered, including carpets, by preventing or 
reducing the adhesion of liquid or solid contaminants to the textile 
fibers. Fluorotelomer carpet treatments are incorporated in polymers 
including fluorinated polyurethanes, fluorinated vinyl polymers and 
fluorinated acrylate and methacrylate polymers. Most of these 
fluorinated polymers have a non-fluorinated backbone with fluorinated 
alkyl chains which provide the desired physical characteristics. 
Fluorinated polyurethanes are noted to be tough but resilient and can 
withstand foot traffic on carpets (Ref. 18).
    PFAS and LCPFAC chemical substances were used in carpets to impart 
stain, soil, and grease repellant properties (Ref. 18). There are four 
typical scenarios for chemical application that could lead to the 
presence of these chemical substances in carpet products, and this SNUR 
would apply to all of them. First, these chemical substances could be 
applied to carpet at a carpet and rug mill during the manufacturing 
process. Second, these chemical substances could be applied to carpet 
after the manufacturing process at a separate finishing facility. 
Third, treatment products containing these chemical substances could be 
applied to carpets in the aftermarket by consumers or professional 
carpet cleaners. In the described scenarios, LCPFAC chemical substances 
could have been domestically produced or imported. Fourth, treated 
carpet fabrics or treated carpet could be imported as articles. 
Domestically produced carpets could be made using imported fabrics that 
had been treated with PFAS or LCPFAC chemical substances or carpet 
containing these chemical substances could be imported into the United 
States as a final product.
    The Agency believes that the LCPFAC chemical substances included in 
this proposal are no longer being manufactured, processed, or imported 
for use as part of carpet or for treating carpet (e.g., for use in the 
carpet aftercare market) in the United States. The Agency also believes 
that LCPFAC chemical substances are not being imported as part of 
carpet. In January 2012, The Carpet and Rug Institute (CRI) informed 
EPA that all members of CRI have voluntarily discontinued the use of 
LCPFAC chemical substances and have switched to alternative compounds 
beginning prior to 2003 and completing sometime near the end of 2005 or 
beginning of 2006 (Ref. 19). CRI is a nonprofit trade association 
representing the manufacturers of more than 95 percent of all carpet 
made in the United States, as well as their suppliers and service 
providers. Although CRI does not track data from non-United States 
manufacturers or the few domestic manufacturers who are not members of 
CRI, EPA's market analysis showed no indication that imported carpet 
products contain PFAS and LCPFAC chemical substances covered by this 
proposal, nor did it show any evidence that these chemical substances 
are manufactured or imported for use as part of carpets (Refs. 20 and 
21). The Agency is concerned that LCPFAC chemicals may in the future be 
used again as part of carpet or for treating carpet, and is hence 
proposing to include these uses among the significant new uses to be 
designated for those chemical substances.

D. What are the potential health and environmental effects of LCPFAC 
chemical substances and the potential sources and routes of exposure to 
these substances?

    The following summary of chemistry, environmental fate, exposure 
pathways, and health and environmental effects of LCPFAC chemical 
substances is based on the December 30, 2009 Long-Chain Perfluorinated 
Chemicals Action Plan (Ref. 1), as well as references cited in the 2009 
Action Plan.
    PFOA is the most studied chemical of the LCPFAC chemical 
substances. PFOA is manufactured for use primarily as an aqueous 
dispersion agent, as the ammonium salt, in the manufacture of 
fluoropolymers, such as PTFE, which have thousands of important 
manufacturing and industrial applications. PFOA can also be produced 
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.
    FTBP can be applied to articles both at the factory and by 
consumers and commercial applicators in after-market uses such as 
carpet treatments and water repellent sprays for apparel and footwear 
(Ref. 18). Therefore, exposure to carpet treatment chemicals may occur 
both during and after the carpet manufacturing process. In 2008, EPA's 
ORD conducted research on 116 articles of commerce and found high 
levels of LCPFAC in carpet and carpet treatment products (levels were 
from 0.04-40,200 nanograms per gram) (Ref. 1). This is of particular 
concern for children since they engage in a variety of activities on 
carpets for longer periods of time in their earliest years and can be 
exposed to chemical substances in carpets via inhalation and dust 
ingestion (Ref. 1).
    PFOA and its higher homologues are highly persistent chemical 
substances that are resistant to degradation under environmental 
conditions. The chemical substances which degrade to form these 
chemicals are called LCPFAC precursors. These precursors may be present 
in the final polymer product as residuals and the amount present in the 
polymer as perfluoroalkyl group (Rf) moieties. The 
availability of LCPFAC precursor from the content of residuals in 
fluorotelomer based polymer products (FTBP) would be small in 
comparison to the amount released should polymeric materials biodegrade 
in the environment. Potentially all monomeric and most if not all 
polymeric products, not just the small amounts of residual monomers and 
other monomer raw material and intermediates, could be LCPFAC 
precursors. LCPFAC can continue to be formed by LCPFAC precursors

[[Page 48929]]

introduced into the environment as they biodegrade with time.
    A limited number of studies on the degradation of fluorotelomers 
have been submitted in support of PMN submissions and existing chemical 
substances, and they have been published in the open literature. Based 
on studies, some fluorotelomer-based polymers are subject to 
hydrolysis, photolysis and biodegradation to some extent. Studies have 
shown half-lives of a few days to hundreds of years. In addition, 
existing research on degradation of fluorotelomers has shown that some 
urethanes and acrylates biodegrade; however, half-lives and kinetics of 
the fluorotelomers are not yet well defined (Ref. 22). Nevertheless, 
these studies have shown unambiguously 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.
    LCPFAC have been detected in biota, air, water, dust, and soil 
samples collected throughout the world. Some LCPFAC chemical substances 
have the potential for long-range transport. They are transported over 
long distances by a combination of dissolved-phase ocean and gas-phase 
atmospheric transport; however, determining which is the predominant 
transport pathway is complicated by many factors including the 
uncertainty over water to atmosphere partitioning. Furthermore, there 
is evidence that transport and subsequent oxidation of volatile alcohol 
LCPFAC precursors contribute to the levels of LCPFAC in the 
environment.
    LCPFAC chemical substances have been detected in human blood 
samples throughout the United States and the world. These compounds 
have also been detected in human breast milk, liver, umbilical cord 
blood, and seminal plasma. Individual samples collected on 
perfluorinated chemical substances in the most recent National Health 
and Nutrition Examination Survey (NHANES) 1999-2009 are similar across 
teens and adults (Ref. 1); however, pooled data from NHANES 2001-2002 
indicate that most of the levels of perfluorinated compounds are higher 
in children ages 3-11 years compared to adults. In addition, a 2009 
Texas survey of 300 children reported PFOS, PFOA, 
perfluorohexanesulfonate (PFHS) and perfluorononanoic acid (PFNA) at 
higher levels in children 9 to 13 years than in 0 to 2 years (Ref. 1).
    Multiple studies have reported a global distribution of LCPFAC in 
wildlife tissue and blood samples. LCPFAC have also been found in a 
variety of aquatic organisms. In general, the highest concentrations in 
wildlife have been found in the livers of fish-eating animals close to 
industrialized areas.
    Animal studies of the straight-chain LCPFAC have shown that these 
compounds are well absorbed orally, but poorly eliminated; they are not 
metabolized, and they undergo extensive uptake from enterohepatic 
circulation. Studies of PFOA have shown that these compounds are 
distributed mainly to the serum, kidney, and liver, with liver 
concentrations being several times higher than serum concentrations; 
the distribution is mainly extracellular. PFOA has a high affinity for 
binding to B-lipoproteins, albumin, and liver fatty acid-binding 
protein. Studies have reported several LCPFAC chemical substances in 
umbilical cord blood, in amniotic fluid, and in blood samples from 
infants and toddlers (Ref. 1).
    In general, the rate of elimination decreases with increasing chain 
length. Elimination in humans takes years (elimination half-life of 
PFOA is 2.3-3.8 years). These compounds will persist and bioaccumulate 
in humans, which means that comparatively low exposures may result in 
large body burdens.
    LCPFAC bioaccumulate and persist in protein-rich compartments of 
fish, birds, and marine mammals, such as carcass, blood, and liver. 
Studies have found fish bioconcentration factor (BCF) values for C8 to 
C14 LCPFAC ranging from 4-40,000 in rainbow trout. Available evidence 
shows the likely potential for bioaccumulation or biomagnifications in 
marine or terrestrial species. Additional evidence that C14 and C15 
LCPFAC bioaccumulate and are bioavailable is their presence in fish, 
invertebrates, and polar bears. The bioaccumulation of LCPFAC is 
thought to represent biomagnification due to high gastrointestinal 
uptake and slow elimination.
    The toxicity of PFOA has been extensively studied and available 
data have raised concerns about LCPFAC chemical substances' potential 
developmental, reproductive, and systemic toxicity (Ref. 1). Although 
there is an extensive database for PFOA, few studies have examined the 
toxicity of other LCPFAC chemical substances. However, the data suggest 
that the toxicity profile is quite similar to that of PFOA, albeit at 
different dose levels.

V. Rationale and Objectives

A. Rationale

    As discussed in Units III and IV, PFAS and LCPFAC chemical 
substances are found world-wide in the environment, wildlife, and 
humans. They are bioaccumulative in wildlife and humans, and are 
persistent in the environment. They are toxic to laboratory animals, 
producing reproductive, developmental, and systemic effects in 
laboratory tests. The exact sources and pathways by which these 
chemicals move into and through the environment and allow humans and 
wildlife to become exposed are not fully understood, but are likely to 
include releases from manufacturing of the chemicals, processing of 
these chemicals into products like carpets and textiles, and aging and 
wear of products containing them.
    Since the manufacture, import, and processing of PFAS and LCPFAC 
chemical substances for the proposed uses have been discontinued, EPA 
expects their presence in humans and the environment to decline over 
time as has been observed in the past when production and use of other 
persistent chemicals has ceased. EPA is concerned that the 
manufacturing, import (including import as part of certain articles), 
or processing of these chemical substances for the proposed new uses 
could be reinitiated in the future. If reinitiated, EPA believes that 
such use would increase the magnitude and duration of exposure to 
humans and the environment to these chemical substances, constituting a 
significant new use.
    EPA is concerned about the potential for PFAS or LCPFAC chemical 
substances (manufactured or imported for an ongoing use) to be 
redirected to other uses without prior notice to the Agency. For 
example, a chemical substance may be initially manufactured or imported 
for a uses listed under Sec.  721.9582(a)(3), (a)(4), or (a)(5), and 
then redirected for another use after its initial manufacture or 
import. EPA is therefore proposing to add the processing of a PFAS 
chemical substances (for any use in the United States, other than the 
uses listed under Sec.  721.9582(a)(3), (a)(4), and (a)(5)) to the 
significant new uses of those chemical substances. For similar reasons, 
EPA is proposing to include the processing of LCPFAC chemical 
substances (for use as part of carpets or to treat carpet) among the 
significant new uses to be designated for those chemical substances. 
While the processing of articles containing PFAS and LCPFAC would 
remain exempt from notice

[[Page 48930]]

requirements, pursuant to Sec.  721.45(f), persons who otherwise 
process PFAS or LCPFAC for a use other than the above-listed uses where 
applicable would be required to first notify EPA, even if they are not 
themselves manufacturers or importers of the chemical substance.
    Accordingly, EPA wants the opportunity to evaluate and control, 
where appropriate, activities associated with those uses, if such 
manufacturing, importing, or processing were to start or resume. The 
required notification provided by a SNUN would provide EPA with the 
opportunity to evaluate activities associated with a significant new 
use and an opportunity to protect against unreasonable risks, if any, 
from exposure to PFAS and LCPFAC chemical substances.
    Consistent with EPA's past practice for issuing SNURs under TSCA 
section 5(a)(2), EPA's decision to propose a SNUR for a particular 
chemical use need not be based on an extensive evaluation of the 
hazard, exposure, or potential risk associated with that use. Rather, 
the Agency's action is based on EPA's determination that if the use 
begins or resumes, it may present a risk that EPA should evaluate under 
TSCA before the manufacturing or processing for that use begins. Since 
the new use does not currently exist, deferring a detailed 
consideration of potential risks or hazards related to that use is an 
effective use of resources. If a person decides to begin manufacturing 
or processing the chemical for the use, the notice to EPA allows EPA to 
evaluate the use according to the specific parameters and circumstances 
surrounding that intended use.
    While the Agency is currently only proposing as significant new 
uses of LCPFAC chemical substances use as part of carpet or to treat 
carpet, the Agency believes the 2010/2015 PFOA Stewardship Program will 
eliminate many other ongoing uses of LCPFAC chemical substances. As 
those uses are phased out in the United States, EPA anticipates taking 
additional regulatory actions to prevent resumption of the uses without 
prior notice to EPA.

B. Objectives

    Based on the considerations in Unit V.A., EPA wants to achieve the 
following objectives with regard to the significant new use(s) that are 
designated in this proposed rule:
    1. EPA would receive notice of any person's intent to manufacture, 
import, or process PFAS or LCPFAC chemicals 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, 
importing, or processing PFAS or LCPFAC chemicals for the described 
significant new use.
    3. EPA would be able to regulate prospective manufacturers, 
importers, or processors of PFAS or LCPFAC chemicals before the 
described significant new use of the chemical substance occurs, 
provided that regulation is warranted pursuant to TSCA sections 5(e), 
5(f), 6 or 7.

VI. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use of the 
PFAS and LCPFAC chemical substances subject to this proposed rule, as 
discussed herein, EPA considered relevant information about the 
toxicity of these substances, likely human exposures and environmental 
releases associated with possible uses, and the four factors listed in 
section 5(a)(2) of TSCA.
    EPA has preliminarily determined that the manufacture, import, 
processing of any of the PFAS chemical substances subject to this 
proposed rule, for any use except ongoing uses specified in Sec.  
721.9582(a)(3) through (a)(5) of the regulatory text in this document, 
is a significant new use. EPA has also preliminarily determined that 
the manufacture, import, or processing of any of the LCPFAC chemical 
substances subject to this proposed rule for use as part of carpet or 
to treat carpets, is a significant new use, and further determined that 
importing any of the LCPFAC chemical substances subject to this 
proposed rule as part of carpet constitutes a significant new use and 
warrants making inapplicable the article exemption at Sec.  721.45(f).

VII. Request for Comment

    EPA welcomes comments on any aspect of this proposed SNUR. EPA 
requests comment on whether any of the uses proposed to be added as 
significant new uses are in fact ongoing, and would request specific 
documentation of any such ongoing use.

VIII. Alternatives

    Before proposing this SNUR, EPA considered the following 
alternative regulatory actions:

A. Promulgate a TSCA Section 8(a) Reporting Rule

    Under a TSCA section 8(a) rule, EPA could, among other things, 
generally require persons to report information to the Agency when they 
intend to manufacture, import, or process a listed chemical for a 
specific use or any use. However, for PFAS and LCPFAC chemical 
substances, the use of TSCA section 8(a) rather than SNUR authority 
would have several limitations. First, if EPA was to require reporting 
under TSCA section 8(a) instead of TSCA section 5(a), EPA would not 
have the opportunity to review human and environmental hazards and 
exposures associated with the proposed significant new use and, if 
necessary, take immediate follow-up regulatory action under TSCA 
sections 5(e) or 5(f) to prohibit or limit the activity before it 
begins. In addition, EPA may not receive important information from 
small businesses, because such firms generally are exempt from TSCA 
section 8(a) reporting requirements. In view of the level of health and 
environmental concerns about PFAS and LCPFAC chemical substances if 
used for the proposed significant new use, EPA believes that a TSCA 
section 8(a) rule for this substance would not meet EPA's regulatory 
objectives.

B. Regulate PFAS and LCPFAC Chemical Substances under TSCA Section 6

    EPA may regulate under TSCA section 6 if ``the Administrator finds 
that there is a reasonable basis to conclude that the manufacture, 
processing, distribution in commerce, use or disposal of a chemical 
substance or mixture * * * presents or will present an unreasonable 
risk of injury to health or the environment.'' (TSCA section 6(a)). 
Given that LCPFAC chemical substances are no longer being used as part 
of a carpet, and that the PFAS chemicals subject to this action have 
not commenced production or import, EPA concluded that risk management 
action under TSCA section 6 for these uses is not necessary at this

[[Page 48931]]

time. This proposed SNUR would allow the Agency to address the 
potential risks associated with the proposed significant new use.

IX. Applicability of Rule to Uses Occurring Before Effective Date of 
the Final Rule

    As discussed in the Federal Register of April 24, 1990 (55 FR 
17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA 
is best served by designating a use as a significant new use as of the 
date of publication of the proposed rule rather than as of the 
effective date of the final rule. If uses begun after publication of 
the proposed rule were considered ongoing rather than new, it would be 
difficult for EPA to establish SNUR notice requirements, because a 
person could defeat the SNUR by initiating the proposed significant new 
use before the rule became final, and then argue that the use was 
ongoing as of the effective date of the final rule. Thus, persons who 
begin commercial manufacture, import, or processing of the chemical 
substance(s) that would be regulated through this proposed rule, if 
finalized, would have to cease any such activity before the effective 
date of the rule if and when finalized. To resume their activities, 
these persons would have to comply with all applicable SNUR notice 
requirements and wait until the notice review period, including all 
extensions, expires. Uses arising after the publication of the proposed 
rule are distinguished from uses that exist at publication of the 
proposed rule. The former would be new uses, the latter ongoing uses. 
To the extent that additional ongoing uses are found in the course of 
rulemaking, EPA would exclude those uses from the final SNUR. EPA has 
promulgated provisions to allow persons to comply with this SNUR before 
the effective date. If a person were to meet the conditions of advance 
compliance under section 721.45(h), that person would be considered to 
have met the requirements of the final SNUR for those activities.

X. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not usually require 
developing any particular test data before submission of a SNUN. There 
are two exceptions: (1) development of test data is required where the 
chemical substance subject to the SNUR is also subject to a test rule 
under TSCA section 4 (see TSCA section 5(b)(1)); and (2) development of 
test data may be necessary where the chemical substance has been listed 
under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence 
of a section 4 test rule or a section 5(b)(4) listing covering the 
chemical substance, persons are required only to submit test data in 
their possession or control and to describe any other data known to or 
reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25, and 
40 CFR 720.50). However, as a general matter, EPA recommends that SNUN 
submitters include data that would permit a reasoned evaluation of 
risks posed by the chemical substance during its manufacture, import, 
processing, use, distribution in commerce, or disposal. EPA encourages 
persons to consult with the Agency before submitting a SNUN. As part of 
this optional pre-notice consultation, EPA would discuss specific data 
it believes may be useful in evaluating a significant new use. SNUNs 
submitted for significant new uses without any test data may increase 
the likelihood that EPA will take action under TSCA section 5(e) to 
prohibit or limit activities associated with this chemical.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs that provide detailed information on:
    1. Human exposure and environmental releases that may result from 
the significant new uses of the chemical substance.
    2. Potential benefits of the chemical substance.
    3. Information on risks posed by the chemical substances compared 
to risks posed by potential substitutes.

XI. SNUN Submissions

    EPA recommends that submitters consult with the Agency prior to 
submitting a SNUN to discuss what data may be useful in evaluating a 
significant new use. Discussions with the Agency prior to submission 
can afford ample time to conduct any tests that might be helpful in 
evaluating risks posed by the substance. According to Sec.  
[emsp14]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 Sec.  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 Sec. Sec.  721.25 
and 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

XII. Economic Analysis

A. SNUNs

    EPA has evaluated the potential costs of establishing SNUR 
reporting requirements for potential manufacturers, importers, and 
processors of the chemical substance included in this proposed rule 
(Ref. 23). In the event that a SNUN is submitted, costs are estimated 
at approximately $8,571 per SNUN submission for large business 
submitters and $6,171 for small business submitters. These estimates 
include the cost to prepare and submit the SNUN, and the payment of a 
user fee. Businesses that submit a SNUN would be subject to either a 
$2,500 user fee required by 40 CFR 700.45(b)(2)(iii), or, if they are a 
small business with annual sales of less than $40 million when combined 
with those of the parent company (if any), a reduced user fee of $100 
(40 CFR 700.45(b)(1)). The costs of submission of SNUNs will not be 
incurred by any company unless a company decides to pursue a 
significant new use as defined in this proposed SNUR. EPA's complete 
economic analysis is available in the public docket for this proposed 
rule (Ref. 23).

B. Export Notification

    Under section 12(b) of TSCA 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 section 5. For 
persons exporting a substance the subject of a SNUR, a one-time notice 
must be provided for the first export or intended export to a 
particular country. The total costs of export notification will vary by 
chemical, depending on the number of required notifications (i.e., the 
number of countries to which the chemical is exported). EPA is unable 
to make any estimate of the likely number of export notifications for 
the chemical covered in this proposed SNUR.

XIII. References

    As indicated under ADDRESSES, a docket has been established for 
this proposed rule under docket ID number EPA-HQ-OPPT-2012-0268. The 
following is a listing of the documents that have been placed in the 
docket for this proposed rule. The docket includes information 
considered by EPA in developing this proposed rule, including the 
documents listed in this unit, which are physically located in the 
docket. In addition, interested parties should consult documents that 
are referenced in the documents that EPA has placed in the docket, 
regardless of whether these referenced documents are physically located 
in the docket. For assistance in locating documents that

[[Page 48932]]

are referenced in documents that EPA has placed in the docket, but that 
are not physically located in the docket, please consult either 
technical person listed under FOR FURTHER INFORMATION CONTACT. The 
docket is available for review as specified under ADDRESSES.

1. USEPA. ``Long-Chain Perfluorinated Chemicals Action Plan.'' 
December 30, 2009.
2. USEPA. ``Perfluoroalkyl Sulfonates; Significant New Use Rule, 
Final Rule.'' 67 FR 11008, March 11, 2002.
3. USEPA. ``Perfluoroalkyl Sulfonates; Proposed Significant New Use 
Rule, Supplemental proposed rule.'' 67 FR 11014, March 11, 2002.
4. USEPA. ``Perfluoroalkyl Sulfonates; Significant New Use Rule, 
Final Rule.'' 67 FR 72854, December 9, 2002.
5. USEPA. ``Perfluoroalkyl Sulfonates; Proposed Significant New Use 
Rule, Final Rule.'' 72 FR 57222, October 9, 2007.
6. 3M Company. Fluorochemical Use, Distribution, and Release 
Overview. St. Paul, Minnesota, May 26, 1999.
7. Weppner, William A., 3M Company. Phase-Out Plan for POSF-Based 
Products, St. Paul, Minnesota, July 7, 2000.
8. R. Renner. 2006. ``The Long and the Short of Perfluorinated 
Replacements.'' Environmental Science and Technology. 40: 12-13.
9. 3M Company. Sulfonated Perfluorochemicals in the Environment: 
Sources, Dispersion, Fate, and Effects. St. Paul, Minnesota, March 
1, 2000.
10. 3M Company. The Science of Organic Fluorochemistry. St. Paul, 
Minnesota, February 5, 1999.
11. 3M Company. Perfluorooctane Sulfonate: Current Summary of Human 
Sera, Health and Toxicology Data. St. Paul, Minnesota, January 21, 
1999.
12. Kudo, Naomi, et. al. ``Comparison of the Elimination Between 
Perfluorinated Fatty Acids with Different Carbon Chain Lengths in 
Rats.'' Chemico-Biological Interactions. Volume 134(2), 2001, pp. 
203-216.
13. Goeke-Flora, Carol M. and Nicholas V. Reo. ``Influence of Carbon 
Chain Length on the Hepatic Effects of Perfluorinated Fatty Acids, 
A\19\ F- and \31\P-NMR Investigation.'' Chemical Research in 
Toxicology, 9(4), 1996, pp. 689-695.
14. Dixon, David A. ``Fluorochemical Decomposition Processes,'' 
Theory, Modeling, and Simulation, William R. Wiley Environmental 
Molecular Sciences Laboratory, Pacific Northwest National 
Laboratory, Richland, Washington, April 4, 2001.
15. Organization for Economic Cooperation and Development (OECD), 
Environment Directorate. ``Hazard Assessment of Perfluorooctane 
Sulfonate (PFOS) and its Salts,'' ENV/JM/RD(2002)17/FINAL, November, 
21, 2002.
16. USEPA. ``Perfluorooctyl Sulfonates; Proposed Significant New Use 
Rule.'' 65 FR 62319, October 18, 2000.
17. USEPA. ``Perfluoroalkyl Sulfonates; Proposed Significant New Use 
Rule, Proposed Rule.'' 71 FR 12311, March 10, 2006.
18. Kissa, David. Fluorinated Surfactants and Repellents. Surfactant 
Science Series. Marcel Dekker, Inc.: New York. 2001.
19. The Carpet and Rug Institute. Letter from Werner H. Braun to 
Maria Doa, Director, CCD, OPPT, USEPA. January 16, 2012.
20. USEPA. ``Market Profile for PFCs Used as Part of Carpets 
(contains proprietary information).'' Washington, DC February 17, 
2012.
21. USEPA. ``Non-Proprietary Market Profile for PFCs Used as Part of 
Carpets.'' Washington, DC February 17, 2012.
22. Washington J.W., Ellington J.J., Thomas M.J., Evans J.J., Hoon 
Yoo, Hafner S.C. (2009). Degradability of an acrylate-linked, 
fluorotelomer polymer in soil Environmental Science and Technology, 
43(17), 6617-6623.
23. USEPA. Economic Analysis of the Significant New use Rule for 
Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl Carboxylate 
Chemical Substances. Prepared by Timothy Lehman and Abt Associates 
Inc. February 16, 2012.

XIV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the 
terms of Executive Order 12866, entitled Regulatory Planning and Review 
(58 FR 51735, October 4, 1993), and was therefore not reviewed by the 
Office of Management and Budget (OMB) under Executive Orders 12866 and 
13563, entitled Improving Regulation and Regulatory Review (76 FR 
3821).
    EPA has prepared an economic analysis of this action, which is 
contained in a document entitled Economic Analysis of the Significant 
New Use Rule for Perfluoroalkyl Sulfonates and Long-Chain 
Perfluoroalkyl Carboxylate Chemical Substances (Ref. 23). A copy of the 
economic analysis is available in the docket for this final rule and is 
summarized in Unit XII.

B. Paperwork Reduction Act

    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., 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, if applicable. The information 
collection requirements related to this action have already been 
approved by OMB pursuant to the PRA under OMB control number 2070-0038 
(EPA ICR No. 1188). This action does not impose any burden requiring 
additional OMB approval. If an entity were to submit a SNUN to the 
Agency, the annual burden is estimated to average 110 hours per 
response. This burden estimate includes the time needed to review 
instructions, search existing data sources, gather and maintain the 
data needed, and complete, review, and submit the required SNUN. Send 
any comments about the accuracy of the burden estimate, and any 
suggested methods for minimizing respondent burden, including through 
the use of automated collection techniques, to the Director, Collection 
Strategies Division, Office of Environmental Information (2822T), 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this SNUR would not have a significant adverse 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 
activity. Since this proposed SNUR would require a person who intends 
to engage in such activity in the future to first notify EPA by 
submitting a SNUN, no economic impact 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 
over 1,000 SNURs, the Agency receives on average only 5 notices per 
year. Of those SNUNs submitted, only one appears to be from a small 
entity in response to any SNUR. Therefore, EPA believes that the 
potential economic impact of complying with this SNUR is not expected 
to be significant or

[[Page 48933]]

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, which was provided to the Chief 
Counsel for Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act

    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, EPA has determined that this regulatory action 
would not impose any enforceable duty, contain any unfunded mandate, or 
otherwise have any effect on small governments subject to the 
requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).

E. Executive Order 13132: Federalism

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

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

    This proposed rule would not have Tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
proposed rule would not significantly or uniquely affect the 
communities of Indian Tribal governments, nor would it involve or 
impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 9, 
2000), do not apply to this proposed rule.

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

    This action is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866, and 
this action does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This proposed rule is not subject to Executive Order 13211, 
entitled Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), 
because this action is not expected to affect energy supply, 
distribution, or use.

I. National Technology Transfer Advancement Act

    Since this action does not involve any technical standards; section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does 
not apply to this action.

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

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

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

    Dated: August 7, 2012.
Wendy Cleland-Hamnett,
Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 721--[AMENDED]

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

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

    2. Add Sec.  721.10536 to subpart E to read as follows:


Sec.  721.10536  Long-chain perfluoroalkyl carboxylate chemical 
substances.

    (a) Definitions. The definitions in Sec.  721.3 apply to this 
section. In addition, the following definition applies: Carpet means a 
finished fabric or similar product intended to be used as a floor 
covering. This definition excludes resilient floor coverings such as 
linoleum and vinyl tile.
    (b) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified below, where n > 5 or 
m > 6, are subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) 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 hetero atom and where X is any chemical moiety, and
    (vi) structurally similar degradation products of any of the 
compounds in (i) through (v) of this paragraph.
    (2) Significant new uses. The significant new uses for chemical 
substance identified in paragraph (b)(1) of this section are: 
manufacture, import, or processing for use as part of carpets or to 
treat carpets (e.g., for use in the carpet aftercare market).
    (c) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Revocation of certain notification exemptions. With respect to 
imports of carpets, the provisions of Sec.  721.45(f) do not apply to 
this section. A person who imports a chemical substance identified in 
this section as part of a carpet is not exempt from submitting a 
significant new use notice. The other provision of Sec.  721.45(f), 
respecting processing a chemical substance as part of an article, 
remains applicable.
    (2) [Reserved]
    3. Section 721.9582 is amended by revising paragraph (a)(1) 
introductory text; by adding Table 4 to paragraph (a)(1) and by 
revising paragraphs (a)(2), (a)(3), (a)(4), and (a)(5) to read as 
follows:


Sec.  721.9582  Certain perfluoroalkyl sulfonates.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances listed in Table 1, Table 2, 
Table 3, and Table 4 of this section are subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
* * * * *

[[Page 48934]]



       Table 4--Fourth Set of PFAS Chemicals Subject to Reporting
------------------------------------------------------------------------
   Premanufacture notice case No.            Generic chemical name
------------------------------------------------------------------------
P-83-0126...........................  2Modified fluoroaliphatic adduct.
P-90-0110...........................  2Fluorochemical epoxide.
P-94-1508...........................  2Fluorinated polysiloxane.
P-94-1509B..........................  2Fluorinated polysiloxane.
P-98-0809...........................  2Fluorochemical esters.
P-99-0296...........................  2Fluoroalkyl derivative.
P-01-0035...........................  2Perfluorooctane sulfonate.
------------------------------------------------------------------------

     (2) The significant new uses are:
    (i) Manufacturing, importing, or processing of any chemical 
substance listed in Table 1 of paragraph (a)(1) of this section for any 
use.
    (ii) Manufacturing, importing, or processing of any chemical 
substance listed in Table 2 of paragraph (a)(1) of this section for any 
use, except as noted in paragraph (a)(3) of this section.
    (iii) Manufacturing, importing, or processing of any chemical 
substance listed in Table 3 of paragraph (a)(1) of this section for any 
use, except as noted in paragraphs (a)(3) through (a)(5) of this 
section.
    (iv) Manufacturing, importing, or processing of any chemical 
substance listed in Table 4 of paragraph (a)(1) of this section for any 
use.
    (3) Manufacturing, importing, or processing of any chemical 
substance listed in Table 2 and Table 3 of paragraph (a)(1) 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 as an anti-erosion additive in fire-resistant phosphate 
ester aviation hydraulic fluids.
    (ii) Use as a component of a photoresist substance, including a 
photo acid generator or surfactant, or as a component of an anti-
reflective coating, used in a photomicrolithography process to produce 
semiconductors or similar components of electronic or other 
miniaturized devices.
    (iii) Use in coating for surface tension, static discharge, and 
adhesion control for analog and digital imaging films, papers, and 
printing plates, or as a surfactant in mixtures used to process imaging 
films.
    (iv) Use as an intermediate only to produce other chemical 
substances to be used solely for the uses listed in paragraph 
(a)(3)(i), (ii), or (iii) of this section.
    (4) Manufacturing, importing, or processing of tetraethylammonium 
perfluorooctanesulfonate (CAS No. 56773-42-3) for use as a fume/mist 
suppressant in metal finishing and plating baths shall not be 
considered as a significant new use subject to reporting under this 
section. Examples of such metal finishing and plating baths include: 
Hard chrome plating; decorative chromium plating; chromic acid 
anodizing; nickel, cadmium, or lead plating; metal plating on plastics; 
and alkaline zinc plating.
    (5) Manufacturing, importing, or processing of: 1-Pentanesulfonic 
acid, 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-, potassium salt (CAS No. 
3872-25-1); Glycine, N-ethyl-N-[(tridecafluorohexyl)sulfonyl]-, 
potassium salt (CAS No. 67584-53-6); Glycine, N-ethyl-N-
[(pentadecafluoroheptyl)sulfonyl]-, potassium salt (CAS No. 67584-62-
7); 1-Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-
pentadecafluoro-, ammonium salt (CAS No. 68259-07-4); 1-
Heptanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-
pentadecafluoro- (CAS No. 68957-62-0); Poly(oxy-1,2-ethanediyl), 
.alpha.-[2-[ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl]-.omega.-
methoxy- (CAS No. 68958-60-1); or 1-Hexanesulfonic acid, 
1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd. with 2,2'-
iminobis[ethanol] (1:1) (CAS No. 70225-16-0) for use as a component of 
an etchant, including a surfactant or fume suppressant, used in the 
plating process to produce electronic devices shall not be considered a 
significant new use subject to reporting under this section.
* * * * *
[FR Doc. 2012-19952 Filed 8-14-12; 8:45 am]
BILLING CODE 6560-50-P