[Federal Register: January 27, 2010 (Volume 75, Number 17)]
[Rules and Regulations]
[Page 4295-4305]
[DOCID:fr27ja10-20]

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ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Part 723

[EPA-HQ-OPPT-2002-0051; FRL-8805-5]
RIN 2070-AD58

Premanufacture Notification Exemption for Polymers; Amendment of
Polymer Exemption Rule to Exclude Certain Perfluorinated Polymers

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is amending the polymer exemption rule, which provides an
exemption from the premanufacture notification (PMN) requirements of
the Toxic Substances Control Act (TSCA), to exclude from eligibility
polymers containing as an integral part of their composition, except as
impurities, certain perfluoroalkyl moieties consisting of a CF3- or
longer chain length. This exclusion includes polymers that contain any
one or more of the following: Perfluoroalkyl sulfonates (PFAS),
perfluoroalkyl carboxylates (PFAC), fluorotelomers, or perfluoroalkyl
moieties that are covalently bound to either a carbon or sulfur atom
where the carbon or sulfur atom is an integral part of the polymer
molecule (affected polymers). In general, any person who intends to
manufacture (which is defined by TSCA to include import into the
customs territory of the United States) any of these polymers not
already on the TSCA Inventory (Inventory) must complete the TSCA PMN
review process prior to commencing the manufacture or import of such
polymers. Alternatively, manufacturers or importers may submit a
request for a different exemption, such as the Low Volume Exemption
(LVE) or Low Release and Exposure Exemption (LoREX), for affected
polymers that they reasonably believe may qualify for such exemptions.
Those persons who are currently manufacturing or importing affected
polymers, or who have previously manufactured or imported them but are
not doing so now, in full compliance with the 1995 polymer exemption
rule, may continue manufacturing or importing them until January 27,
2012. After that date, manufacture of these polymers will no longer be
authorized under the polymer exemption rule, and continued manufacture
or import must be authorized under a different TSCA section 5(h)(4)
exemption or under a different TSCA section 5 authority, such as TSCA
section 5(a)(1) or section 5(e). This change is necessary because,
based on current information, EPA can no longer conclude that these
polymers ``will not present an unreasonable risk to human health or the
environment'' under the terms of the polymer exemption rule, which is
the determination necessary to support an exemption under TSCA section
5(h)(4).

DATES: This final rule is effective February 26, 2010.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2002-0051. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. 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, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket 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 legal
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 general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address: TSCA-
<EMAIL_ADDRESS>    For technical information contact: Geraldine Hilton, Chemical
Control Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture
or import polymers that contain as an integral part of their
composition, except as impurities, certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length (affected polymers). As
specified in the regulatory text of this final rule (40 CFR
723.250(d)(6)), these perfluoroalkyl moieties include any one or more
of the following: PFAS, PFAC, fluorotelomers, or perfluoroalkyl
moieties that are covalently bound to either a carbon or sulfur atom
where the carbon or sulfur atom is an integral part of the polymer
molecule. Persons who import or intend to import polymers that are
covered by this final rule would be subject to TSCA section 13 (15
U.S.C. 2612) import certification requirements, and to the regulations
codified at 19 CFR 12.118 through 12.127 and 127.28. Those persons must
certify that they are in compliance with the PMN requirements. The EPA
policy in support of import certification appears at 40 CFR part 707,
subpart B. Importers of formulated products that contain a polymer that
is subject to this final rule as a component (for example, for use as a
water-proof coating for textiles or as a top anti-reflective coating
(TARC) used to manufacture integrated circuits) may also be potentially
affected. A list of potential monomers and reactants that could be used
to manufacture polymers that would be affected by this final rule may
be found in the public docket (Ref. 7). Potentially affected entities
may include, but are not limited to: Chemical manufacturers or
importers (NAICS code 325), e.g., persons who manufacture (defined by
statute to include import) one or more of the subject chemical
substances.

    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 723.250. 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.

II. Background

A. What Action is the Agency Taking?

    In the Federal Register issue of March 7, 2006 (Ref. 26), the
Agency proposed to exclude from the polymer exemption rule (40 CFR
723.250), which exempts certain chemical substances from TSCA section 5
PMN requirements, polymers containing as an integral part of their
composition, except as impurities, certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length. The proposed exclusion
included polymers that contain any one or more of the following: PFAS,
PFAC, fluorotelomers, or perfluoroalkyl moieties that are covalently
bound to either a carbon or sulfur atom where the carbon or sulfur atom
is an integral part of the polymer molecule. EPA is finalizing the rule
as proposed, with two changes related to the implementation of the
final rule. The first applies to the effective date of the final rule,
which will be 30 days after date of publication in the Federal Register
instead of 12 months, as was proposed. The second will allow persons
who are currently manufacturing or importing affected polymers, or who
have previously manufactured or imported them but are not doing so now,
in full compliance with the 1995 polymer exemption rule, 24 months to
complete the TSCA section 5 review process instead of 12 months, as was
proposed. EPA is also clarifying that manufacturers and importers of
affected polymers may submit a request for a different TSCA section
5(h)(4) exemption, such as a LVE or LoREX request, in lieu of a PMN, if
they reasonably believe that the subject polymers may qualify for those
exemptions. See Unit III.E. for additional information on
implementation of the final rule.
    Non-confidential information related to this final rule may be
found in administrative record number (AR) AR-226, which is the public
administrative record that the Agency has established for
perfluorinated chemical substances generally. Interested parties should
consult AR-226 for additional information on PFAS, PFAC,
fluorotelomers, or other perfluoroalkyl moieties. To receive an index
of AR-226, contact the EPA/DC by telephone:<PHONE_NUMBER> or e-mail:
<EMAIL_ADDRESS>    Additional information may be found in docket ID number EPA-HQ-
OPPT-2003-0012 which covers the Agency's enforceable consent agreement
(ECA) process for certain of these chemical substances. See ADDRESSES
for instructions on accessing a public docket.

B. What is the Agency's Authority for Taking this Action?

    Section 5(a)(1)(A) of TSCA requires persons to notify EPA at least
90 days before they manufacture or import a new chemical substance for
commercial purposes. Section 3(9) of TSCA defines a ``new chemical
substance'' as any chemical substance that is not on the Inventory
compiled by EPA under TSCA section 8(b). Section 5(h)(4) of TSCA
authorizes EPA, upon application and by rule, to exempt the
manufacturer or importer of any new chemical substance from part or all
of the provisions of TSCA section 5 if the Agency determines that the
manufacture, processing, distribution in commerce, use, or disposal of
such chemical substance, or any combination of such activities will not
present an unreasonable risk of injury to human health or the
environment. Section 5(h)(4) of TSCA also authorizes EPA to amend or
repeal such rules. EPA has acted under these authorities to amend the
polymer exemption rule at 40 CFR 723.250.

C. Why is the Agency Taking this Action?

    1. Polymers containing PFAS or PFAC. EPA is amending the polymer
exemption rule, last amended in 1995, to exclude polymers containing
PFAS or PFAC, because the Agency has received information which
suggests that polymers containing PFAS or PFAC may degrade and release
fluorochemical residual compounds into the environment. Once released,
PFAS or PFAC are expected to persist in the environment, may
bioaccumulate, and may be highly toxic. Accordingly, EPA can no longer
make the determination that the manufacturing, processing, distribution
in commerce, use, or disposal of polymers containing PFAS or PFAC
``will not present an unreasonable risk to human health or the
environment'' under the terms of the polymer exemption rule, as
required under TSCA section 5(h)(4).
    2. Polymers containing fluorotelomers or other perfluoroalkyl
moieties. EPA is also excluding polymers that contain fluorotelomers,
or that contain perfluoroalkyl moieties consisting of a CF3- or longer
chain length that are covalently bound to either a carbon or sulfur
atom where the carbon or sulfur atom is an integral part of the polymer
molecule. Initial studies have demonstrated toxic effects of certain
compounds containing fluorotelomers (derived from the 8-2 alcohol,
Chemical Abstracts Service Registry Number (CAS No.) 678-39-7).
Preliminary investigations have found that fluorotelomer alcohols were
present in the air above several cities, indicating that these chemical
substances may be widely distributed and that air may be a route of
exposure. Based on the available data, EPA expects that polymers
containing fluorotelomers or perfluoroalkyl moieties that are
covalently bound to either a carbon or sulfur atom where the carbon or
sulfur atom is an integral part of the polymer molecule may degrade in
the environment thereby releasing fluorotelomer alcohols or other
perfluoroalkyl-containing chemical substances. It is possible that,
once released, such moieties may potentially degrade to form PFAS or
PFAC. Accordingly, EPA can no longer conclude that polymers containing
fluorotelomers and these other perfluoroalkyl moieties ``will not
present an unreasonable risk of injury to health or the environment''
under the terms of the polymer exemption rule, as required for an
exemption under TSCA section 5(h)(4). Therefore, EPA is excluding such
polymers from the polymer exemption at 40 CFR 723.250.

III. Final Rule

A. History Subsequent to the 1995 Amendment to the Polymer Exemption
Rule

    The 1995 amendments to the polymer exemption rule published in the
Federal Register issue of March 29, 1995 (Ref. 28) expanded the polymer
exemption to include polymers made from reactants that contain certain
halogen atoms, including fluorine. The best available information in
1995 indicated that most halogen containing compounds, including
unreactive polymers containing PFAS and PFAC chemical substances, were
chemically and environmentally stable and would not

present an unreasonable risk to human health and the environment. In
1999, however, the 3M Company (3M) provided the Agency with preliminary
reports that indicated widespread distribution of perfluorooctane
sulfonate (PFOS) in humans, the environment and wildlife (Refs. 8-10).
In addition, on May 16, 2000, 3M announced that it would phase out
perfluorooctanyl chemistry in light of the persistence of certain
fluorochemicals and their detection at extremely low levels in the
blood of the general population and wildlife. 3M indicated that
production of these chemical substances would be substantially
discontinued by the end of 2000 (Ref. 11). Based on this information
from 3M, EPA began to investigate potential risks from PFOS and other
perfluorinated chemical substances, as well as polymers containing
these chemical substances. It is possible that polymers containing PFAS
or PFAC chemical substances may degrade, releasing these chemical
substances into the environment where they are expected to persist. The
number of carbon atoms on the PFAS or PFAC molecule, whether as a
single compound, or as a component of a polymer, may influence
bioaccumulation potential and toxicity. Based on the available data,
EPA expects that polymers containing fluorotelomers or perfluoroalkyl
moieties that are covalently bound to either a carbon or sulfur atom
where the carbon or sulfur atom is an integral part of the polymer
molecule may degrade, releasing these chemical substances into the
environment where they may further degrade into PFAS or PFAC.

B. EPA's Responses to Comments Received on the Proposed Rule

    EPA specifically requested comments on the following issues in the
proposed rule:
     Whether exemption is appropriate under the polymer
exemption rule for polymers containing perfluoroalkyl moieties that are
covalently bound to either a carbon or sulfur atom where the carbon or
sulfur atom is an integral part of the polymer molecule and where the
perfluoralkyl moiety consists of a CF3- or longer chain length.
     Alternatives for implementing the final rule that would
achieve the purposes of TSCA section 5 without disrupting ongoing
manufacture or import of currently exempt polymers.
    The Agency received comments on these and other aspects of the
proposed rule. Comments were submitted by the Society of the Plastics
Industry, E.I. DuPont de Nemours and Company, 3M Company, the People's
Republic of China, International Imaging Industry Association, Peach
State Labs, Inc., Dainippon Ink & Chemicals, Inc., and Clariant
Corporation. Summaries of significant comments and EPA's responses to
them are included in a separate document entitled ``Response to
Comments on the Polymer Exemption Rule Amendment'' (Ref. 2). This
document is available in the public docket established for this final
rule.

C. Defining Polymers that are Subject to this Final Rule

    1.  Polymers containing PFAS or PFAC. This final rule applies to a
large group of polymers containing one or more fully fluorinated alkyl
sulfonate or carboxylate groups. None of these polymers occur
naturally. Such polymers are considered ``new chemical substances''
under TSCA if they have not been included in the Inventory compiled and
published under TSCA section 8(b) (15 U.S.C. 2607(b)). For a list of
examples of the Ninth Collective Index of Chemical Abstracts of
chemical names and CAS numbers of chemical substances used to make
polymers that are subject to this final rule, see Ref. 7. EPA has
concerns for the perfluorinated carbon atoms in the Rf
(Rf=Perfluoroalkyl CF3- or greater) substituent, in this unit, when
that Rf unit is associated with the polymer through the carbonyl (PFAC)
or sulfonyl (PFAS) group. How these materials are incorporated into the
polymer is immaterial (they may be counter ions, terminal/end capping
agents, or part of the polymer backbone).

                                                       O                                 .......................
                                  ..................   [par]...........................
                                  PFAC..............  Rf--C--Hetero atom (typically N
                                                       or O)-Polymer.
                                                      .................................
                                                      .................................
                                                       Rf=Perfluoroalkyl CF3- or
                                                       greater.
                                                                                .......................
                                                       O                                 .......................
                                  ..................   [par]...........................
                                  PFAS..............  Rf--S--Hetero atom (typically N
                                                       or O)-Polymer.
                                                       [par]...........................
                                                       O...............................
                                                                                .......................

    This final rule specifically excludes from the polymer exemption at
40 CFR 723.250 polymers that contain any PFAS or PFAC group consisting
of a CF3- or longer chain length. EPA has increasing concerns as the
number of carbon atoms that are perfluorinated in any individual Rf
substituent increases. PFOA (perfluorooctanoate) is a PFAC (see top
structure) which has 7 carbon atoms in the Rf moiety (CAS nomenclature
rules count the carbonyl carbon atom as the eighth carbon for naming
purposes, hence the octanoate terminology). PFOS is a PFAS (see bottom
structure) which has 8 carbon atoms in the Rf moiety. Generally, the
longer the chain of perfluorinated C atoms, the greater the persistence
and retention time in the body; furthermore, the C8 chain length has
been associated with adverse health effects in laboratory animals.
    Most of the toxicity data currently available on PFAS and PFAC
chemical substances pertain to the PFOS potassium salt (PFOSK) and the
PFOA ammonium salt (APFO). There is some evidence that PFAS/PFAC
moieties with longer carbon chains may present greater concerns than
PFAS/PFAC moieties with shorter-carbon chains (Refs. 3, 12-14).
However, EPA has insufficient information at this time to determine a
limit for which shorter chain lengths ``will not present an
unreasonable risk to human health or the environment'' under the terms
of the polymer exemption rule.

    2. Polymers containing fluorotelomers or other perfluoroalkyl
moieties. EPA is also excluding from the polymer exemption at 40 CFR
723.250 polymers that contain fluorotelomers, or that contain
perfluoroalkyl moieties of a CF3- or longer chain length that are
covalently bound to either a carbon or sulfur atom where the carbon or
sulfur atom is an integral part of the polymer molecule.
    i. Fluorotelomers. One method that is commonly used to incorporate
perfluorinated compounds into polymers is to use fluorotelomers, such
as perfluoroalkyl ethanol or its derivatives. Telomerization is the
reaction of a telogen with a polymerizable ethylenic compound to form
low molecular weight polymeric compounds, commonly referred to as a
telomer. For example, the reaction of pentafluoroethyl iodide (a
telogen) with tetrafluoroethylene forms a fluorotelomer iodide
intermediate which is then reacted with ethylene and converted into
perfluoroalkyl ethanol. This chemical substance can be further reacted
to form a variety of useful intermediates which may subsequently be
incorporated into the polymer (Ref. 15). The fluorochemical group
formed by the telomerization process is predominantly straight chain,
and depending on the telogen used produces a product having an even
number of carbon atoms. However, the chain length of the fluorotelomer
varies widely. A representative structure for these compounds is:

    F-(CF2-CF2)x-Anything (often CH2-
CH2-O-Polymer) x >= 1

    ii. Other perfluoroalkyl moieties. Perfluoroalkyl moieties that are
covalently bound to either a carbon or sulfur atom where the carbon or
sulfur atom is an integral part of the polymer molecule can be attached
to the polymers using conventional chemical reactions. A representative
structure for these compounds is:

    F-(CF2)x-(C,S)-Polymer x >= 1

D. Concerns with Respect to Polymers Containing PFAS, PFAC,
Fluorotelomers, or Other Perfluoroalkyl Moieties

    1. Polymers containing PFAS or PFAC. EPA has received and reviewed
data on the PFAS and PFAC chemical substances PFOS and PFOA,
respectively, and on other perfluoroalkyl acids. PFAS and PFAC are used
in a variety of polymeric chemical substances to impart oil and water
resistance, stain and soil protection, and reduced flammability. The
same features that make the polymeric coatings containing PFAS or PFAC
useful, allow the polymeric compound to be stable to the natural
environmental conditions that produce degradation. However, it has been
demonstrated in certain circumstances that PFAS and PFAC-containing
compounds will undergo degradation (chemical, microbial, or photolytic)
of the non-fluorinated portion of the molecule leaving the remaining
perfluorinated acid untouched (Ref. 22). Further degradation of the
perfluoroalkyl residual compounds is extremely difficult. In
particular, EPA has evidence that polymers containing PFAS or PFAC may
degrade, possibly by incomplete incineration, and that these
perfluorinated chemical substances may be released into the environment
(Ref. 16). Under routine conditions of municipal waste incinerators
(MWIs), incinerated chemical substances are exposed to 1,000[deg]C
temperature for long retention times. Those conditions are sufficient
to cleave the normally stable C-F bonds. However, when MWIs do not
maintain sufficiently high temperatures or sufficiently long retention
times to cleave the stable C-F bond, it is possible that the PFAS and
PFAC produced by oxidative thermal decomposition of the polymers will
remain intact and can be released into the environment (Ref. 16).
    PFOS and PFOA have been found in the blood of workers exposed to
the chemical substances and in the general populations of the United
States and other countries (Refs. 3, 17, and 18). They have also been
found in many terrestrial and aquatic animal species worldwide (Refs.
3, 17, and 18). As discussed in this unit, PFAS and PFAC chemical
substances used in the production of polymers may be released into the
environment by degradation. It is possible, therefore, that the
widespread presence of PFOS and PFOA in the environment may be due, in
part, to the degradation of such polymers and the subsequent release of
the PFAS and PFAC components into the environment. However, the method
of degradation and global distribution is uncertain. The widespread
distribution of the chemical substances also suggests, and
biomonitoring studies confirm, that human exposure to PFOS and PFOA may
be widespread. In particular, in a 2007 National Health and Nutrition
Examination Survey (NHANES) report, PFOS, PFOA, perfluorohexane
sulfonic acid (PFHxS) and perfluorononanoic acid (PFNA) were detected
in > 98% of the serum samples from a representative sample of the
general U.S. population >= 12 years of age (Ref. 21 and see also the
Response to Comments Document (Ref. 2)).
    PFOS and PFOA have shown liver, developmental, and reproductive
toxicity in animal studies (Ref. 3). Animal test data indicate that
PFOS and PFOA may cause cancer (Ref. 3). An occupational study reported
an excess of bladder cancer in a small number of workers at a plant
that manufactured perfluorinated chemical substances; however, follow
up studies have not confirmed an increase in bladder cancer incidence
in workers (Ref. 3). EPA included a comprehensive discussion of use and
production volume data, exposure data, and environmental fate and
health effects data for PFOS and PFOA and other PFAS and PFAC chemical
substances in the proposed rule (Ref. 26, pp. 11489-11497). That
comprehensive discussion is incorporated here as modified by EPA's
responses to public comments received by the Agency on aspects of that
discussion (Ref. 2). Although the Agency has far more data on PFOS and
PFOA than on other PFAS and PFAC chemical substances, EPA expects that,
based on available data, other PFAS and PFAC chemical substances of
CF3- or longer chain length may share similar toxicity, persistence,
and bioaccumulation characteristics that need to be evaluated.
    Some commenters objected to EPA's statement in the proposed rule
that it believes other PFAS and PFAC chemical substances of CF3- or
longer chain length may share similar toxicity, persistence, and
bioaccumulation characteristics that need to be evaluated and what they
asserted were other ``generalized'' statements in the proposed rule,
noting that each PFAS and PFAC chemical substance should be examined on
its own merits with respect to toxicity, bioaccumulation, and
persistence. EPA agrees that individual PFAS and PFAC chemical
substances, like the polymers that contain them, should be evaluated
based on their own merits. That is precisely why it has excluded
affected polymers from the polymer exemption rule. This action will
allow EPA to evaluate affected polymers individually, based on their
own merits, through the PMN process or under other appropriate
exemption criteria. EPA also emphasizes that it has not stated in the
preambles to the proposed rule or this final rule that other PFAS or
PFAC chemical substances categorically share similar toxicity,
bioaccumulation, and persistence characteristics with PFOS and PFOA.
EPA has only stated that it believes that they may, or are expected to,
share similar characteristics, based

on available information and its professional judgment and experience.
    Consideration of available information on specific chemical
substances in light of EPA's professional judgment and expertise, in
order to draw reasonable conclusions about the potential risks of
similar chemical substances, has long been an integral component of
EPA's implementation of the polymer exemption rule. This has been the
case whether EPA is expanding the scope of the exemption (see, for
example, Ref. 27, pp. 7679, 7682-7683, in which EPA explained the basis
for expanding the scope of the exemption to include polymers that
contain halogen groups, based on analysis of health and ecotoxicity
data for specific polymers that previously had been evaluated under the
PMN program) or narrowing it (see, for example, Ref. 28, pp. 16316,
16319-16320, in which EPA excluded a category of water-absorbing
polymers from the exemption, based on a single toxicity study submitted
under TSCA section 8(e)).
    In this instance, EPA stated in the proposed rule that, based on
currently available information, EPA believed that, while all PFAS and
PFAC chemical substances are expected to persist, the length of the
perfluorinated chain may have an effect on the other areas of concern
for these chemical substances, such as bioaccumulation and toxicity.
EPA also stated that there was evidence that PFAS/PFAC moieties with
longer carbon chains may present greater concerns for bioaccumulation
potential and toxicity than PFAS/PFAC moieties with shorter-carbon
chains. However, carbon chain length may only be one factor in
determining retention time. As discussed in the Response to Comments
document (Ref. 2), data received since the proposed rule was published
generally supports these statements.
    The Agency continues to investigate the physicochemical properties,
the environmental fate and distribution, and the toxicity of PFAS and
PFAC chemical substances, including polymers already in production. A
recent journal article provides an overview of the monitoring data
available for the environment, wildlife, and humans, as well as recent
advances in the toxicology and mode of action for this class of
compounds (Ref. 3). These data help the Agency to evaluate these
polymers to ascertain any potential risks on a case-by-case basis.
However, available data are still insufficient to determine the carbon
number below which PFAS and PFAC chemical substances ``will not present
an unreasonable risk.'' At this time, therefore, EPA can no longer
conclude that polymers containing PFAS or PFAC will not present an
unreasonable risk to human health or the environment under the terms of
the polymer exemption rule. Therefore, this final rule excludes
polymers containing PFAS or PFAC from eligibility for exemption from
TSCA section 5(a)(1)(A) reporting requirements for new chemical
substances under the polymer exemption rule.
    2. Polymers containing fluorotelomers or other perfluoroalkyl
moieties. EPA has received data on various perfluorinated chemical
substances that indicate that the Agency should evaluate polymers that
contain these perfluoroalkyl moieties through the PMN process. As
discussed in the proposed rule (Ref. 26, p. 11497), there is a growing
body of data demonstrating that fluorotelomer alcohols metabolize or
degrade to generate PFOA. For example, the fluorotelomer alcohol [CA
Index Name: 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-Heptadecafluorodecan-
1-ol; CAS No. 678-39-7], also known as 8-2 alcohol, has been shown to
degrade to form PFOA when exposed to activated sludge during
accelerated biodegradation studies (Refs. 3, 19, and 20).
    Initial test data from a study in rats dosed with fluorotelomer
alcohol and other preliminary animal studies on various telomeric
products containing fluorocarbons structurally similar to PFAC or PFAS
have demonstrated a variety of adverse effects including liver, kidney
and thyroid effects (Refs. 3 and 5).
    Preliminary investigations have demonstrated the presence of
fluorotelomer alcohols in the air in six different cities (Ref. 6).
This finding is significant because it is indicative of not only
widespread fluorotelomer alcohol distribution, but also it further
indicates that air may be a route of direct or indirect exposure to
these chemical substances, which can be degraded or metabolized to form
PFOA. Fluorotelomer alcohols are generally incorporated into the
polymers via covalent ester linkages, and it is possible that
degradation of the polymers may result in release of the fluorotelomer
alcohols to the environment.
    Based on the presence of fluorotelomer alcohols in the air, the
growing data demonstrating that fluorotelomer alcohols metabolize or
degrade to generate PFOA, the preliminary toxicity data on certain
compounds containing fluorotelomers (such as the 8-2 alcohol), and the
possibility that polymers containing fluorotelomers as an integral part
of the polymer composition may degrade in the environment thereby
releasing fluorotelomer alcohols or other perfluoroalkyl-containing
chemical substances, EPA can no longer conclude that polymers
containing fluorotelomers as an integral part of the polymer
composition ``will not present an unreasonable risk of injury to health
or the environment'' under the terms of the polymer exemption rule as
required for an exemption under TSCA section 5(h)(4).
    Although EPA does not have specific data demonstrating that
polymers containing perfluoroalkyl moieties other than PFAS, PFAC, or
fluorotelomers present the same concerns as those containing PFAS,
PFAC, or fluorotelomers, EPA is nevertheless excluding polymers
containing perfluoroalkyl groups, consisting of a CF3- or longer chain
length, that are covalently bound to either a carbon or sulfur atom
where the carbon or sulfur atom is an integral part of the polymer
molecule from the polymer exemption. Based on available data which
indicate that compounds containing PFAS or PFAC may degrade in the
environment thereby releasing the PFAS or PFAC moiety, and that
fluorotelomers may degrade in the environment to form PFAC, it is
possible that polymers containing these other types of perfluoroalkyl
moieties may also degrade over time in the environment thereby
releasing the perfluoroalkyl moiety. Based on available data, EPA
expects that once released, such moieties may potentially degrade to
form PFAS or PFAC. EPA therefore cannot continue to make the ``will not
present an unreasonable risk of injury to health or the environment''
finding under the terms of the polymer exemption rule for such
polymers.

E. Implementation

    The proposed rule would have established an effective date for the
final rule that was 1 year after the date of publication of the final
rule. This would have allowed manufacturers or importers of affected
polymers who were already manufacturing or importing such polymers in
full compliance with the terms of the polymer exemption rule, to
continue manufacture or import for a period of 1 year after the date of
publication of the final rule. However, in order to continue
manufacturing or importing affected polymers after the 1-year period,
manufacturers or importers would have had to complete the PMN review
process within the 1-year period before the final rule became
effective.
    As an alternative to the 1 year effective date, EPA also
specifically

sought comment on an implementation approach that would have
established an effective date 30 days after publication of the final
rule, but provide an extended compliance date for those who, prior to
the effective date, had already initiated the manufacture or import of
affected polymers (see Ref. 26, pp. 11484, 11488). Under the
alternative approach, the TSCA section 5(a)(1)(A) requirement to submit
a PMN for a new chemical substance would have been re-established with
respect to affected polymers beginning 30 days after publication of the
final rule. However, those who were manufacturing or importing affected
polymers in full compliance with the existing exemption would have had
1 year from the effective date to complete the PMN process. EPA
specifically requested comment on these or other implementation
approaches.
    Commenters generally asserted that 1 year was not enough time to
develop a PMN and to complete the PMN review process. Several
commenters suggested as an alternative that EPA require submission of a
PMN within a year or that it extend the 1-year ``grace period'' to 3
years. One commenter also requested clarification regarding whether a
LVE request could be submitted in lieu of a PMN in order to comply with
this final rule. Upon review of these comments and proposed
alternatives, EPA agrees that 1 year would likely not provide
sufficient time to complete the PMN review process for all affected
polymers currently being manufactured or imported under the polymer
exemption rule. The Agency has therefore changed the proposed approach,
and is also clarifying that requests for different TSCA section 5(h)(4)
exemptions, such as a LVE or LoREX request, may be submitted to comply
with the final rule, if manufacturers or importers reasonably believe
affected polymers may qualify for such exemptions.
    The effective date of this final rule will be 30 days after its
publication in the Federal Register, which is the minimum required by
section 553(c) of the Administrative Procedure Act. Accordingly, the
TSCA section 5(a)(1)(A) requirement to submit a PMN (or alternate
exemption request, if appropriate) for a new chemical substance applies
to all affected polymers beginning 30 days after publication of the
final rule in the Federal Register. However, EPA is providing an
extended compliance date for those who, prior to the effective date of
the final rule, had already initiated the manufacture or import of
affected polymers in full compliance with the 1995 polymer exemption
rule. Specifically, this final rule allows manufacturers or importers
of affected polymers, who are in full compliance with the terms of the
1995 polymer exemption rule, to continue manufacture or import of such
polymers under the polymer exemption rule until January 27, 2012. If
PMNs for these polymers have not been reviewed by the Agency and the
polymers have not been listed on the TSCA Inventory or, in the case of
exemption requests, EPA has not granted the exemption request by
January 27, 2012, such manufacture or import must cease. With respect
to PMN submissions, the company must submit a notice of commencement
(NOC) within 30 days of commencing non-exempt manufacturing (see 40 CFR
720.102), so that the polymer can be placed on the TSCA Inventory where
appropriate, after the review of the PMN submission. The NOC must be
filed as a condition of continued manufacture or import. A company may
at any time during the review process elect to withdraw its PMN or
exemption request. If a manufacturer or importer elects to withdraw its
PMN or exemption request, all manufacturing or importing activity must
cease as of January 27, 2012.
    EPA will strive to complete the review of the PMN (or alternate
exemption request) submitted in response to this final rule promptly.
For those PMNs for which EPA determines that action under TSCA section
5(e) may be necessary, the 90-day review period is generally suspended
by the reviewer as the consent order is developed/negotiated. In
addition, at any time in the review period, EPA may determine that good
cause exists to extend the PMN notice review period for a total period
of extension not to exceed 90 days (see 40 CFR 720.75). However, for
polymers currently being manufactured under the terms of the existing
polymer exemption rule, the TSCA section 5 review process must be
completed by January 27, 2012. Therefore, the Agency recommends that
manufacturers currently manufacturing affected polymers under the
polymer exemption rule submit their PMNs early in the 24 months
following the publication of this final rule. In particular,
manufacturers intending to submit an LVE or LoREX should do so as soon
after the effective date as possible to ensure that they have adequate
time to submit a PMN in case the Agency denies the LVE or LoREX. In
addition to reviewing the applicable regulations pertaining to
submission of PMNs and alternate TSCA section 5(h)(4) exemption
requests, manufacturers may consult with the OPPT New Chemicals
Management Branch ((202) 564-9373) in the TSCA New Chemicals Program to
determine what information will enable timely review.
    EPA decided on this approach because the proposed rule would have
inadvertently allowed polymers not already being manufactured under the
polymer exemption rule to be manufactured or imported for a year
without going through the PMN or other TSCA section 5 review process.
As noted in the proposed rule, the delayed effective date was intended
to provide current manufacturers or importers of affected polymers who
are in full compliance with the terms of the existing polymer exemption
rule additional time to come into compliance with the final rule,
without disrupting their ability to manufacture or import those
polymers. (Ref. 26, p. 11487). Those who are not currently
manufacturing or importing affected polymers would not experience such
disruptions. Accordingly, EPA believes it is reasonable to make the
effective date of the final rule 30 days after publication in the
Federal Register, but provide additional time to complete the TSCA
section 5 review process for manufacturers or importers who began
manufacturing or importing affected polymers in full compliance with
the terms of the existing polymer exemption rule prior to the effective
date of the final rule.
    EPA has extended by 12 months the time that manufacturers and
importers who are currently manufacturing or importing affected
polymers would have had under the proposed rule to complete the TSCA
section 5 review process. Under the proposed rule, such manufacturers
would have had to submit a PMN to EPA within 6 months after publication
of the final rule in order for EPA to have had the entire 180 day
period authorized by TSCA section 5 to complete the PMN review. This
time frame may have been too short in some circumstances. For example,
one trade group indicated that notifications for imported affected
polymers might take longer than normal to prepare because its members
would need to coordinate with non-domestic suppliers to obtain
information, which may be proprietary, on formulations that they
import. Another commenter observed that manufacturers or importers may
need to submit bona fide letters of intent prior to submitting a PMN to
determine whether affected polymers that they manufacture or import are
already listed on the Inventory.

    Under this final rule, such manufacturers and importers will have
up to 18 months to submit a PMN in order for EPA to have the entire 180
day review period (90 days plus opportunity for up to a 90-day
extension under TSCA section 5(c)) to complete the review. This
approach will allow such manufacturers and importers additional time to
compile the information necessary to prepare and submit PMNs or
exemption requests. However, EPA encourages manufacturers and importers
to submit PMNs or alternate exemption requests as soon as possible
after publication of the final rule. Doing so will provide EPA with
more time to complete consent orders and, if necessary, establish
testing requirements for those polymers for which EPA may have concerns
of potential unreasonable risk to human health or the environment.
    The proposed regulatory text in 40 CFR 723.250(d)(6)(i) has
therefore been changed from ``Except ... may no longer be manufactured
after January 27, 2011 unless that polymer has undergone a
premanufacture review ...'' to: ``Any polymer that has been
manufactured previously in full compliance with the requirements of
this section prior to February 26, 2010 may no longer be manufactured
under this section after January 27, 2012.''
    Manufacturers or importers of affected polymers that are already on
the Inventory compiled and published under TSCA section 8(b) (15 U.S.C.
2607(b)) are not impacted by this final rule. The PMN requirements in
TSCA section 5(a) apply only to new chemical substances which are those
that are not included on the Inventory of Chemical Substances.

IV. Objective and Rationale for this Final Rule

    The objective of this final rule is to amend the polymer exemption
rule to exclude polymers containing as an integral part of the polymer
composition, except as impurities, any one or more of certain
perfluoroalkyl moieties consisting of a CF3- or longer chain length
from eligibility for the exemption from TSCA section 5 reporting
requirements allowed under the 1995 amendments to the polymer exemption
rule. In TSCA section 5(a)(1)(A), Congress prohibited persons from
manufacturing (including importing) new chemical substances unless such
persons submitted a PMN to EPA at least 90 days before such
manufacture. Pursuant to TSCA section 5(h)(4), EPA is authorized to
exempt the manufacturer of any new chemical substance from all or part
of the requirements of TSCA section 5 if the Agency determines that the
manufacture, processing, distribution in commerce, use, or disposal of
the chemical substance, or any combination of such activities, will not
present an unreasonable risk of injury to health or the environment.
Section 5(h)(4) of TSCA also authorizes EPA to amend or repeal such
rules.
    The polymer exemption rule is intended to exempt certain polymers
from certain TSCA section 5 requirements polymers because EPA believes
those exempted polymers pose a low risk of injury to health or the
environment. The exemption criteria are therefore designed to exempt
polymers that are of low concern because of their stability, molecular
size, and lack of reactivity, among other properties. EPA has excluded
certain polymers from the exemption where:
     The Agency has insufficient data and review experience to
support a finding that they will not present an unreasonable risk; or
     The Agency has found that under certain conditions, the
polymers may present risks which require a closer examination of the
conditions of manufacturing, processing, distribution, use, and
disposal during a full 90-day PMN review (i.e., the Agency has
information suggesting that the conditions for an exemption under TSCA
section 5(h)(4) are not met).
    This approach allows the Agency to maintain full regulatory
oversight over potentially higher risk polymers while streamlining the
review process for low-risk polymers.
    Based on the data currently available, for the reasons stated
herein, EPA can no longer can make a generally applicable finding,
without additional information, that the manufacture, processing,
distribution in commerce, use, and/or disposal of affected polymers
will not present an unreasonable risk of injury to health or the
environment under the terms of the polymer exemption rule.

V. Economic Considerations

    EPA has evaluated the potential costs of eliminating the polymer
exemption for the chemical substances described in this final rule. The
results of this evaluation are contained in a document entitled
``Economic Analysis of the Amendment to the Polymer Exemption Rule to
Exclude Certain Perfluorinated Polymers'' (Ref. 1). A copy of this
economic analysis is available in the public docket for this action,
and is briefly summarized here.
    The industry costs for completing and submitting a PMN reporting
form are estimated to be $8,269 per chemical substance. Because the
final rule would eliminate the cost of complying with the recordkeeping
and reporting requirements of the polymer exemption rule, the cost for
completing and submitting a PMN as a result of this amendment is
reduced by $372, for a net cost of $7,897 per chemical substance (Ref.
1).
    Companies that currently manufacture an affected polymer under the
exemption are estimated to incur a total net cost of $7,897 per
chemical substance. Companies that do not currently manufacture an
affected polymer, but begin to manufacture such polymers in the future,
may also incur potential net costs of $14,522 associated with potential
delays in commercialization of the new chemical substance. These
companies are estimated to incur a total cost of $22,419 per chemical
substance as a result of this final rule (Ref. 1). These net costs do
not include the following per chemical substance costs that would have
been incurred had a manufacturer of an affected polymer been allowed to
continue to submit an exemption notification under the polymer
exemption rule (i.e., had this amendment to the polymer exemption rule
not been finalized):
     $372 for recordkeeping and reporting costs.
     $9,572 commercialization delay cost.
    The potential number of PMNs that may be submitted each year under
the final rule was estimated using the 292 polymer reports received by
EPA annually between 1996 and 2006 under the polymer exemption rule.
EPA estimates this final rule could affect a maximum of 6% of the 292
polymers reported annually, and, therefore, estimates that a maximum of
18 PMNs may be submitted each year under the final rule. Using the same
estimated number of 18 chemical substances per year for the 14 years
(1996 through 2009) during which affected polymers were exempt from PMN
requirements under the polymer exemption rule, 252 previously exempt
chemical substances (18 chemical substances x 14 years) could be
expected to have a PMN submitted under the final rule. EPA expects to
receive the majority of PMNs for previously exempt chemical substances
during the second year of the proposed rule. However, because EPA has
no way of predicting accurately the actual timing of the submissions,
EPA is averaging the 252 PMNs over the 2-year period and is assuming
that 126 PMNs for previously exempt chemical substances will be
submitted in each of

the first 2 years after publication of the final rule.
    In addition, EPA is expecting a maximum of 18 PMNs to be submitted
to the Agency each year for new chemical substances. Therefore, the
Agency estimates that a maximum of 144 PMNs (126 + 18) might be
submitted during each of the first 2 years after the effective date of
the final rule, and that a maximum of 18 PMNs might be submitted in
each subsequent year.
    Using the estimated per chemical substance costs and the estimated
number of PMNs anticipated, EPA estimates the potential PMN submission
costs to industry in each of the first 2 years of the final rule for
manufacturers of 144 chemical substances (126 previously exempt new
chemical substances and 18 new chemical substances) to be $1,398,564,
or $1.4 million per year, including $995,022 for previously exempt
chemical substances (126 chemical substances x $7,897 per chemical
substance) + $403,542 (18 new chemical substances x $22,419). This will
decrease to an estimated annual cost of $403,542 in the third year and
beyond for the maximum of 18 PMNs that EPA believes could be submitted
annually by manufacturers and importers of new chemical substances that
are no longer eligible for the exemption.
    While the final rule clarifies that other TSCA section 5(h)(4)
exemption requests may be submitted. EPA estimates that the cost of
preparing an LVE or a LoREX is equal to the cost of preparing a PMN.
However, LVEs and LoREXs are not subject to the $2,500 user fee.
Accordingly, if the Agency receives no LVE or LoREXs notices as a
result of this clarification, then Agency estimated costs are not
affected by this clarification. However, if the Agency does receive any
LVE or LoREX notices, then estimated costs would be overstated because
these notices would not be subject to the user fee. The Agency has
never received a photographic film exemption request and does not
expect to as a result of this final rule
    In addition, as was the case prior to the promulgation of the
polymer exemption rule in 1995, the Agency recognizes that the
submission of a PMN may lead to other regulatory actions under TSCA,
for example consent orders issued under TSCA section 5(e). Any such
actions are highly dependent on the circumstances surrounding the
individual PMN (e.g., available information and scientific
understanding about the chemical substance and its risks at the time
the PMN is being reviewed). Such potential actions and any costs
associated with them would not be a direct result of this final rule.
Nevertheless, the economic analysis does contain a brief discussion of
the Agency's previous and ongoing regulatory activities with respect to
potentially affected polymers.

VI. References

    As indicated under ADDRESSES, a docket has been established for
this final rule under docket ID number EPA-HQ-OPPT-2002-0051. The
following is a listing of the documents that are specifically
referenced in this final rule. References from the proposed rule that
have not been referenced in the final rule are relevant to EPA's
decisions in this final rule and can also be found in this docket. The
docket includes these documents and other information considered by EPA
in developing this final rule, including documents that are referenced
within the documents that are included in the docket, even if the
referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
    Reference documents identified with an ``AR'' designation are
cross-indexed to non-regulatory, publicly accessible information files
maintained in the EPA/DC. Copies of these documents can be obtained as
described in ADDRESSES.
    1. EPA. Economic Analysis of the Amendment to the Polymer Exemption
Rule To Exclude Certain Perfluorinated Polymers. Wendy Hoffman (EPA/
OPPT/Economics, Exposure and Technology Division (EETD)). October 19,
2009.
    2. EPA. Response to Comments on the Polymer Exemption Rule
Amendment. July 14, 2009.
    3. Lau, C.; Anitole, K.; Hodes, C.; Lai, D.; Pfahles-Hutchens, A.;
Seed, J. Perfluoroalkyl Acids: A Review of Monitoring and Toxicological
Findings. Toxicological Sciences. Vol. 99(2), pp. 366-394. 2007.
    4. (AR-226-1440) Hagen, D.F.; Belisle, J.; Johnson, J.D.;
Venkateswarlu, P. Characterization of fluorinated metabolites by a gas
chromatographic-helium microwave plasma detector--the biotransformation
of 1H, 1H, 2H, 2H-perfluorodecanol perfluorooctanoate. Analytical
Biochemistry. Vol. 118(2), pp. 336-343. 1981.
    5. (AR-226-1147) DuPont presentation to the Agency at the meeting
held on November 25, 2002.
    6. (AR-226-1281) Scott Mabury, P.I. Interim Annual Report of
Activities for TRP Grant to University of Toronto; Project years: 1
September, 2001 to 1 September, 2002.
    7. Memo from Dr. Gregory Fritz (EPA/OPPT/EETD) to Mary Begley (EPA/
OPPT/Chemical Control Division (CCD)) re: Polymer Feedstocks Resulting
in Excluded Polymers. April 18, 2002.
    8. (AR-226-0620) Sulfonated Perfluorochemicals in the Environment:
Sources, Dispersion, Fate, and Effects. 3M. St. Paul, MN. March 1,
2000.
    9. (AR-226-0547) The Science of Organic Fluorochemistry. 3M. St.
Paul, MN. February 5, 1999.
    10. (AR-226-0548) Perfluorooctane Sulfonate: Current Summary of
Human Sera, Health and Toxicology Data. 3M. St. Paul, MN. January 21,
1999.
    11. (AR-226-0600) Weppner, William A. Phase-out Plan for PFOS-Based
Products. 3M. St. Paul, MN. July 7, 2000.
    12. Kudo, Naomi, et al. Comparison of the Elimination Between
Perfluorinated Fatty Acids with Different Carbon Chain Lengths in Rats.
Chemico-Biological Interactions. Vol. 134(2), pp. 203-216. 2001.
    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.
Vol. 9(4), pp. 689-695. 1996.
    14. (AR-226-1030a109) Fluorochemical Decomposition Processes. 3M.
St. Paul, MN. April 4, 2001.
    15. Bultman, David and Pike, Myron. The Use of Fluorochemical
Surfactants in Floor Polish. 3M. St. Paul, MN.
    16. (AR-226-0550) Fluorochemical Use, Distribution and Release
Overview. 3M. St. Paul, MN. May 26, 1999.
    17. (AR-226-1093) Seed, Jennifer. Hazard Assessment of
Perfluorooctanoic Acid and Its Salts, Revised Draft (EPA/OPPT/Risk
Assessment Division (RAD)). Washington, DC. November 4, 2002.
    18. (AR-226-1140) Organization for Economic Co-operation and
Development (OECD), Hazard Assessment of Perfluorooctane sulfonate
(PFOS) and its Salts. OECD Publication No. ENV/JM/ RD(2002)17/FINAL.
November 21, 2002.
    19. (AR-226-1149) Biodegradation screen studies for telomer type
alcohols. 3M. November 6, 2002.
    20. (AR-226-1262) DuPont Executive Summary--Biodegradation
Screening Studies of 8-2 Telomer B Alcohol. March 20, 2003.
    21. Calafat, A.; Wong, L.; Kuklenyik, Z.; Reidy, J.; Needham, L.
Polyfluoroalky Chemicals in the U.S. Population: Data from the National
Health and Nutrition Examination

Survey (NHANES) 2003-2004 and Comparisons with NHANES 1999-2000.
Environmental Health Perspectives. Vol. 115(11), pp. 1596-1602. 2007.
    22. Remde, A. and Debus, R. Biodegradability of Fluorinated
Surfactants Under Aerobic and Anaerobic Conditions. Chemosphere. Vol.
32(8), pp. 1563-1574. 1996.
    23. OECD, Screening Information Data Sets (SIDS). Ammonium
Perfluorooctanate & Perfluorooctanoic Acid, SIDS Initial Assessment
Report (SIAR). April 2006.
    24. United Nations Environment Program/Persistent Organic
Pollutants/Persistent Organic Pollutants Review Committee (UNEP/POPS/
POPRC). Draft risk profile: Perfluorooctane sulfonate (PFOS). July
2006.
    25. Ellis, D.A.; Mabury, S.A.; Martin, J.W.; Muir, D.C.G.
Thermolysis of fluoropolymers as a potential source of halogenated
organic acids in the environment. Nature. Vol. 412, pp. 321-324. 2001.
    26. EPA. Premanufacture Notification Exemption for Polymers;
Amendment of Polymer Exemption Rule to Exclude Certain Perfluorinated
Polymers; Proposed Rule. Federal Register (71 FR 11483, March 7, 2006)
(FRL-7735-5).
    27. EPA. Premanufacture Notification Exemptions; Revisions of
Exemptions for Polymers; Proposed Rule. Federal Register (58 FR 7679,
February 8, 1993) (FRL-3890-1).
    28. EPA. Premanufacture Notification Exemptions; Revisions of
Exemptions for Polymers; Final Rule. Federal Register (60 FR 16316,
March 29, 1995) (FRL-4929-8).

VII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), and was not therefore reviewed
by the Office of Management and Budget (OMB) under Executive Order
12866.
    EPA has prepared an economic analysis of the potential impacts
associated with this action. A copy of this economic analysis,
``Economic Analysis of the Amendment to the Polymer Exemption Rule to
Exclude Certain Perfluorinated Polymers'' (Ref. 1) is available in the
public docket for this action and is briefly summarized in Unit V.

B. Paperwork Reduction Act

    The information collection requirements related to the submission
of PMNs are already approved by OMB under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq. That Information Collection Request (ICR)
document has been assigned EPA ICR number 0574 and OMB control number
2070-0012. This final rule does not impose any new requirements that
require additional OMB approval.
    Under PRA, ``burden'' means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. 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 PMN, and maintain the
required records.
    Based on the estimated burden in the existing ICR, if an entity
were to submit a PMN to the Agency, the annual reporting burden is
estimated to average between 95 and 114 hours per response, with a
midpoint respondent burden of 107 hours. This estimate was adjusted to
account for the elimination of the existing burden related to the
recordkeeping and reporting requirements in the polymer exemption rule,
which is estimated to impose a burden on industry of 6 hours per
chemical substance, i.e., 2 hours for reporting, and 4 hours for
recordkeeping. The net paperwork burden for submitting a PMN as a
result of this final amendment is therefore estimated to be 101 hours
per PMN submission. The net cost to submit a PMN under the final rule
is estimated to be $5,397. In addition, PMN submissions must be
accompanied by a user fee of $2,500 (set at $100 for small businesses
with annuals sales of less than $40 million). These net paperwork hours
and associated costs do not include the per chemical substance 6 hour
burden and $372 associated cost that would have been incurred had a
manufacturer of an affected polymer been allowed to continue to submit
an exemption notification under the polymer exemption rule (i.e., had
this amendment to the polymer exemption rule not been finalized).
    The final rule clarifies that other TSCA section 5(h)(4) exemption
requests may be submitted in lieu of PMNs. EPA estimates that the cost
of preparing an LVE or a LoREX is equal to the cost of preparing a PMN.
However, LVEs and LoREXs are not subject to the $2,500 user fee.
Accordingly, if the Agency receives no LVE or LoREXs notices as a
result of this clarification, then Agency estimated costs are not
affected by this clarification. However, if the Agency does receive any
LVE or LoREX notices, then estimated costs would be overstated because
these notices would not be subject to the user fee. The Agency has
never received a photographic film exemption request and does not
expect to as a result of this final rule.
    For the first 2 years after publication of the final rule, EPA
estimates that the one-time burden for the companies that submit PMNs
for chemical substances already in production will be a maximum of
12,726 hours (126 chemical substances x 101 hours per submission).
Based on the high-end assumption of 18 PMNs for new chemical substances
annually, the annual burden is estimated to be 1,818 hours (18 x 101
hours). Therefore, EPA estimates that the burden in each of the first
two years for the 144 PMNs will be 14,544 hours. The burden is expected
to decrease to 1,818 hours in the third year of the final rule and
beyond.
    An agency may not conduct or sponsor, and a person is not required
to respond to an information collection request subject to PRA unless
it displays a currently valid OMB control number. The OMB control
numbers for EPA's regulations are listed in 40 CFR part 9 and included
on any related collection instrument (e.g., on the form or survey).

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 this action
will not have a significant adverse economic impact on a substantial
number of small entities. The Agency's basis is briefly summarized here
and the analysis is detailed in the economic analysis (Ref. 1).
    Small entities include small businesses, small organizations, and
small governmental jurisdictions. For purposes of assessing the impacts
of this final rule on small entities, small entity is defined as:
    1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201 based on the
applicable NAICS code for the business sector impacted.
    2. A small governmental jurisdiction that is a government of a
city, county, town, school district or special district with a
population of less than 50,000.
    3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
    The regulated community does not include any small governmental
jurisdictions or small not-for-profit

organizations. For small businesses, the Agency assessed the impacts on
small chemical manufacturers in NAICS codes 325 and 324110. The SBA
size standards for sectors under NAICS code 325 range from 500 to 1,000
employees or fewer in order to be classified as small. The size
standard for NAICS code 324110, petroleum refineries, is 1,500
employees.
    As summarized in Unit V., the industry costs for completing and
submitting a PMN reporting form are estimated to be $7,897 per chemical
substance (Ref. 1). Small businesses with less than $40 million in
annual sales are entitled to a reduced user fee of $100 for submitting
a PMN, rather than the $2,500 user fee, which would reduce the per PMN
costs for small businesses to $5,497 per chemical substance.
    Based on estimates of the number of PMNs expected to be submitted
as a result of this action, it appears that 12 or fewer businesses
would be affected per year (Ref. 1). The five companies that
manufacture the majority of the volume of chemical substances that will
be affected by the polymer exemption rule belong to either or both of
the Fluoropolymer Manufacturers Group and the Telomer Research Program.
These two groups, which have no other members beyond the five
companies, have negotiated TSCA section 4 ECAs and other voluntary
testing arrangements with the Agency for testing specific chemical
substances that would be affected by the polymer exemption rule. The
two groups have told the Agency that their member companies manufacture
the majority of the volume of chemical substances that would be
affected by the final rule. None of these five companies meet the
definition of small under the Small Business Administration employee
size criteria. The remaining volume of chemical substance that could be
affected by the final rule is low enough so that even if a small
company were to be affected, a significant number of businesses would
not be affected, nor would any individual small business experience
significant impacts.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates for State, local, or
tribal governments or the private sector under the provisions of Title
II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-
1538. This action will not have an annual impact of $100 million or
more on the private sector, nor will it impact State or tribal
governments. Based on EPA's experience with past PMNs, State, local,
and tribal governments have not been affected by this reporting
requirement, and EPA does not have any reason to believe that any
State, local, or tribal government will be affected by this final rule.
As such, EPA has determined that this regulatory action does not impose
any enforceable duty, contain any unfunded mandate, or otherwise have
any affect on small governments subject to the requirements of sections
202 or 205 of UMRA.

E. Executive Order 13132

    Pursuant to Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999), EPA has determined that this action does not
have federalism implications because it will not have substantial
direct effects on the 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 the Order. Thus, Executive Order 13132 does not apply to this final
rule.

F. Executive Order 13175

    As required by Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000), EPA has determined that this action does not have tribal
implications because it will not have any affect on tribal governments,
on the relationship between the Federal government and the Indian
tribes, or on the distribution of power and responsibilities between
the Federal government and Indian tribes, as specified in the Order.
Thus, Executive Order 13175 does not apply to this final rule.

G. Executive Order 13045

    EPA interprets Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997), as applying only to those regulatory actions that
concern health or safety risks, such that the analysis required under
section 5-501 of Executive Order 13045 has the potential to influence
the regulation. This action is not subject to Executive Order 13045
because it does not establish an environmental standard intended to
mitigate health or safety risks.

H. Executive Order 13211

    This action is not a ``significant energy action'' as defined in
Executive Order 13211, entitled Actions Concerning Regulations that
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) because it is not likely to have a significant adverse
effect on the supply, distribution, or use of energy.

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

    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).
EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 723

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

    Dated: January 15, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.

0
 Therefore, 40 CFR chapter I is amended as follows:

PART 723--[AMENDED]

0
1. The authority citation for part 723 continues to read as follows:

    Authority: 15 U.S.C. 2604.

0
2. Section 723.250 is amended by adding the definitions below in
alphabetical order to paragraph (b) and by adding a new paragraph
(d)(6) to read as follows:

Sec.  723.250  Polymers.

* * * * *
     (b) * * *
    Fluorotelomers means the products of telomerization, which is the
reaction of a telogen (such as pentafluoroethyl iodide) with an
ethylenic compound (such as tetrafluoroethylene) to form low molecular
weight polymeric compounds, which contain an array of saturated carbon
atoms covalently bonded to each other (C-C bonds) and to fluorine atoms
(C-F bonds). This array is predominantly a straight chain, and
depending on the telogen used produces a compound having an even number
of carbon atoms. However, the carbon chain length of the fluorotelomer
varies widely. The perfluoroalkyl groups formed by this process are
usually, but do not have to be, connected to the polymer through a
functionalized ethylene group as indicated by the following structural
diagram: (Rf-CH2CH2-Anything).
* * * * *
    Perfluoroalkyl carboxylate (PFAC) means a group of saturated carbon
atoms covalently bonded to each other in a linear, branched, or cyclic
array and covalently bonded to a carbonyl moiety and where all carbon-
hydrogen (C-H) bonds have been replaced with carbon-fluorine (C-F)
bonds. The carbonyl moiety is also covalently bonded to a hetero atom,
typically, but not necessarily oxygen (O) or nitrogen (N).
    Perfluoroalkyl sulfonate (PFAS) means a group of saturated carbon
atoms covalently bonded to each other in a linear, branched, or cyclic
array and covalently bonded to a sulfonyl moiety and where all carbon -
hydrogen (C-H) bonds have been replaced with carbon - fluorine (C-F)
bonds. The sulfonyl moiety is also covalently bonded to a hetero atom,
typically, but not necessarily oxygen (O) or nitrogen (N).
* * * * *
    (d) * * *
     (6) Polymers which contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length. Except as provided in
paragraph (d)(6)(i), after February 26, 2010, a polymer cannot be
manufactured under this section if the polymer contains as an integral
part of its composition, except as impurities, one or more of the
following perfluoroalkyl moieties consisting of a CF3- or longer chain
length: Perfluoroalkyl sulfonates (PFAS), perfluoroalkyl carboxylates
(PFAC), fluorotelomers, or perfluoroalkyl moieties that are covalently
bound to either a carbon or sulfur atom where the carbon or sulfur atom
is an integral part of the polymer molecule.
    (i) Any polymer that has been manufactured previously in full
compliance with the requirements of this section prior to February 26,
2010 may no longer be manufactured under this section after January 27,
2012.
    (ii) [Reserved]
* * * * *

[FR Doc. 2010-1477 Filed 1-26-2010; 8:45 am]
BILLING CODE 6560-50-S