[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19952]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl
Carboxylate Chemical Substances; Proposed Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is
proposing to amend a significant new use rule (SNUR) for 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@example.com.
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.
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
Potentially affected entities may include, but are not limited to:
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
Carpet and rug mills (NAICS code 314110),
Fiber, yarn, and thread mills (NAICS code 31311),
Home furnishing merchant wholesalers (NAICS code 423220),
Carpet and upholstery cleaning services (NAICS code
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
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,
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,
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
vi. Provide specific examples to illustrate your concerns and
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
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.
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
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
B. What action has the agency previously taken on other PFAS chemical
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.
C. What are the uses and production levels of the PFAS chemical
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
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
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
B. What are the uses and production levels of LCPFAC chemical
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
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
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
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
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
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
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
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
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.
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
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
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
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.
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
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
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
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.
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
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
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,
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.
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,
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,
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,
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
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
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
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
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.
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
1. The authority citation for part 721 continues to read as
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
(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.
where M = H\+\ or any other group where a formal dissociation can be
(iii) CF3(CF2)n-C(=O)-X where X is
any chemical moiety;
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,
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
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.
* * * * *
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
(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
(iv) Manufacturing, importing, or processing of any chemical
substance listed in Table 4 of paragraph (a)(1) of this section for any
(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
(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
(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-
pentadecafluoro- (CAS No. 68957-62-0); Poly(oxy-1,2-ethanediyl),
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