Premanufacture Notification Exemption for Polymers; Amendment of Polymer Exemption Rule to Exclude Certain Perfluorinated Polymers, 4295-4305 [2010-1477]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 17 (Wednesday, January 27, 2010)]
[Rules and Regulations]
[Pages 4295-4305]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1477]


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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 https://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 https://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: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.
    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: (202) 564-8986; e-mail 
address: hilton.geraldine@epa.gov.

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.

[[Page 4296]]

    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: (202) 566-1744 or e-mail: 
docket-customerservice@epa.gov.
    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

[[Page 4297]]

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.

[[Page 4298]]

    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

[[Page 4299]]

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

[[Page 4300]]

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.

[[Page 4301]]

    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

[[Page 4302]]

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

[[Page 4303]]

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