Premanufacture Notification Exemption for Polymers; Amendment of Polymer Exemption Rule to Exclude Certain Perfluorinated Polymers, 11484-11504 [06-2152]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 44 (Tuesday, March 7, 2006)]
[Proposed Rules]
[Pages 11484-11504]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-2152]



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Part IV





Environmental Protection Agency





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40 CFR Part 723



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

Federal Register / Vol. 71, No. 44 / Tuesday, March 7, 2006 / 
Proposed Rules

[[Page 11484]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 723

[EPA-HQ-OPPT-2002-0051; FRL-7735-5]
RIN 2070-AD58


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to amend 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 proposed 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. If finalized as proposed, any 
person who intends to manufacture (or import) any of these polymers not 
already on the TSCA Inventory would have to complete the TSCA 
premanufacture review process prior to commencing the manufacture or 
import of such polymers. EPA believes this proposed change to the 
current regulation is necessary because, based on recent information, 
EPA can no longer conclude that these polymers ``will not present an 
unreasonable risk to human health or the environment,'' which is the 
determination necessary to support an exemption under TSCA, such as the 
polymer exemption rule.

DATES: Comments must be received on or before May 8, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2002-0051, by one of the following methods:
     https://www.regulations.gov. Follow the on-line 
instructions for submitting comments.
     E-mail: oppt.ncic@epa.gov.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID number EPA-HQ-OPPT-2002-0051. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the Docket's normal hours of operation, and 
special arrangements should be made for deliveries of boxed 
information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2002-0051. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available on-line 
at https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov your 
e-mail address will be automatically captured and included as part of 
the comment that is placed in the public docket and made available on 
the Internet. If you submit an electronic comment, EPA recommends that 
you include your name and other contact information in the body of your 
comment and with any disk or CD ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the 
regulations.gov index. Although listed in the index, some information 
is not publicly available, e.g., 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 electronically through regulations.gov or in 
hard copy at the OPPT Docket, EPA Docket Center (EPA/DC), EPA West, Rm. 
B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket 
Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Public Reading Room is (202) 566-1744, and the telephone number for the 
OPPT Docket is (202) 566-0280.

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. General Information

A. 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 proposed regulatory text (Sec.  723.250(d)(6)), this 
includes 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. Persons who import or 
intend to import polymers that are covered by the 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 a subject of this 
proposed 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

[[Page 11485]]

that would be affected by this rulemaking may be found in the public 
docket (Ref. 1). Potentially affected entities may include, but are not 
limited to:
     Chemical manufacturers or importers (NAICS 325), e.g., 
persons who manufacture (defined by statute to include import) one or 
more of the subject chemical substances.
     Chemical exporters (NAICS 325), e.g., persons who export, 
or intend to export, 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.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as 
CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket number and other identifying 
information (subject heading, Federal Register date, and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at the estimate.
    vi. Provide specific examples to illustrate your concerns and 
suggested alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What Action is the Agency Taking?

    The Agency is proposing 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. This exclusion 
includes 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. The effective date of the 
final rule would be one year from the date of publication of the final 
rule. Manufacture or import of any of these polymers not already on the 
TSCA Inventory, including polymers currently being produced under the 
polymer exemption rule, would no longer be eligible for the polymer 
exemption and, in the case of continued manufacture or import after the 
effective date of the final rule, would require completion of the 
premanufacture review requirements under TSCA section 5(a)(1)(A) and 40 
CFR part 720 prior to the effective date of the final rule. After 
expiration of the one year period between the publication date of the 
final rule and the effective date, the PMN requirement would apply in 
full to manufacturers and importers of all polymers that are subject to 
the final rule.
    EPA is actively working with industry to develop more complete data 
on affected polymers. In light of these efforts, certain publicly 
available and confidential business information regarding the specific 
chemicals manufactured, current production volumes, uses/applications, 
environmental fate and effects, and toxicity of the polymeric materials 
that would be subject to this proposed rule has been made and continues 
to be made available to EPA on an ongoing basis. Accordingly, EPA may 
supplement the public docket for this proposed rule with relevant non-
confidential business information as it is received by the Agency. Non-
confidential information related to this proposed rule may also be 
found in administrative record number (AR) AR-226, which is the public 
administrative record that the Agency has established for 
perfluorinated chemicals 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 Docket Center by telephone: (202) 566-0280 or e-mail: 
oppt.ncic@epa.gov.
    Additional information may be found in EPA Docket ID No. OPPT-2003-
0012, which covers the Agency's enforceable consent agreement (ECA) 
process for certain of these chemicals. Instructions on accessing an 
EPA public docket are provided at the beginning of this document under 
ADDRESSES.

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 substance that is not on the Inventory of Chemical 
Substances compiled by EPA under section 8(b) of TSCA. 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 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) also authorizes EPA to amend or repeal 
such rules. EPA is acting 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 proposing to amend the 
polymer exemption rule, last amended in 1995, because the Agency has 
received information which suggests that polymers containing PFAS or 
PFAC may degrade and release fluorochemical

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residual compounds into the environment. Once released, PFAS or PFAC 
are expected to persist in the environment, are expected to 
bioaccumulate, and are expected to be highly toxic. Accordingly, EPA 
believes that it 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'' as required under TSCA 
section 5(h)(4).
    PFAS or PFAC are used in a variety of polymeric 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. It has been demonstrated that PFAS or PFAC-containing 
compounds can undergo degradation (chemical, microbial, or photolytic) 
of the non-fluorinated portion of the molecule leaving the remaining 
perfluorinated acid untouched (Ref. 2). Further degradation of the 
perfluoroalkyl residual compounds is extremely difficult. Even under 
routine conditions of municipal waste incinerators (MWIs), the Agency 
believes that the PFAS and PFAC produced by oxidative thermal 
decomposition of the polymers will remain intact (the typical 
conditions of a MWI are not stringent enough to cleave the carbon-
fluorine bonds) to be released into the environment. EPA has evidence 
that polymers containing PFAS or PFAC may degrade, possibly by 
incomplete incineration, and release these perfluorinated chemicals 
into the environment (Ref. 3).
    EPA has received data on the PFAS and PFAC chemicals 
perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA), 
respectively. Biological sampling recently revealed the presence of 
PFOS and PFOA in fish, birds, and mammals, including humans across the 
United States and in other countries. The widespread distribution of 
the chemicals suggests that PFOS and PFOA may bioaccumulate. PFOS and 
PFOA have a high level of toxicity and have shown liver, developmental, 
and reproductive toxicity at very low dose levels in exposed laboratory 
animals (Ref. 4).
    Although the Agency has far more data on PFOS and PFOA than on 
other PFAS and PFAC chemicals, EPA believes that other PFAS and PFAC 
chemicals of CF3- or longer chain length may share similar toxicity, 
persistence and bioaccumulation characteristics. Based on currently 
available information, EPA believes that, while all PFAS and PFAC 
chemicals are expected to persist, the length of the perfluorinated 
chain may have an effect on the other areas of concern for these 
chemicals: Bioaccumulation and toxicity. PFAS and PFAC chemicals with 
longer carbon chain lengths may be of greater concern (Refs. 5, 6, and 
7). EPA has insufficient evidence at this time, however, to 
definitively establish a lower carbon chain length limit to meet the 
``will not present an unreasonable risk'' finding, which is the 
determination necessary to support an exemption under section 5(h)(4) 
of TSCA.
    The Agency, working in cooperation with the fluorochemical 
industry, has been investigating the physicochemical properties, the 
environmental fate and distribution, and the toxicity of PFAS and PFAC 
chemicals, including polymers already in production. These data help 
the Agency to evaluate these polymers to ascertain any potential risks 
on a case-by-case basis.
    2. Polymers containing fluorotelomers or other perfluoroalkyl 
moieties. EPA is also proposing to exclude from the exemption 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. EPA has received data on various 
perfluorinated chemical substances that indicate potential concerns and 
that the Agency should evaluate polymers that contain these 
perfluoroalkyl moieties through the PMN process. For example, the 
fluorotelomer alcohol 2-(perfluorooctyl)ethanol [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 (Ref. 8).
    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 (Ref. 9).
    Preliminary investigations have demonstrated the presence of 
fluorotelomer alcohols in the air in 6 different cities (Ref. 10). This 
finding is significant because it is indicative of widespread 
fluorotelomer alcohol distribution and it further indicates that air 
may be a route of exposure to these chemicals, which can ultimately 
become 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 (Ref. 11), 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 substances, EPA believes that it 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'' as required for an exemption under section 5(h)(4) 
of TSCA. Therefore, EPA is proposing to exclude polymers that contain 
such fluorotelomers from the polymer exemption at 40 CFR 723.250.
    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 proposing to exclude 
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 indicates 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, EPA 
believes that it is possible for polymers containing these other types 
of perfluoroalkyl moieties to also degrade over time in the environment 
thereby releasing the perfluoroalkyl moiety. EPA also believes that 
once released, such moieties may potentially degrade to form PFAS or 
PFAC. EPA does not believe, therefore, that it can continue to make the 
``will not present an unreasonable risk of injury to health or the 
environment'' finding for such polymers and is proposing to exclude 
them from the polymer exemption. EPA is specifically requesting comment 
on this aspect of the proposed rule. Please see Unit VII. of this 
document for

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specific information that EPA is interested in obtaining to evaluate 
whether continued exemption for 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 is appropriate.

D. Would Manufacturers or Importers of Affected Polymers That Were 
Previously Manufactured Under the Terms of the Polymer Exemption Rule 
Need to Complete the PMN Review Process or to Cease Production?

    This proposed rule would allow manufacturers or importers of 
affected polymers, who are in full compliance with the terms of the 
polymer exemption rule, to continue manufacture or import for a period 
of one year after the date of publication of the final rule. However, 
after the one-year period, polymers that are subject to the final rule 
(including affected polymers made under the polymer exemption rule 
since promulgation of the 1995 amendment to the rule) would no longer 
be eligible for exemption under the polymer exemption rule. Therefore, 
a person who intends to continue manufacturing or importing polymers 
subject to the final rule without interruption would have to complete 
the PMN review process before the effective date in order to comply 
with the final rule. Manufacturers or importers of polymers that are 
already on the Inventory of Chemical Substances compiled and published 
under section 8(b) of TSCA (15 U.S.C. 2607(b)) would not be affected by 
this proposed amendment. The PMN requirements in section 5(a) of TSCA 
apply only to new chemical substances which are those that are not 
included on the Inventory of Chemical Substances. However, several of 
the polymers that are already included on the Inventory of Chemical 
Substances are subject to control actions under TSCA section 5, 
including section 5(e) consent orders and section 5(a)(2) Significant 
New Use Rules (SNURS).

III. Summary of This Proposed Rule

A. Polymers Containing PFAS or PFAC

    EPA is proposing to amend the polymer exemption rule (40 CFR 
723.250) to exclude polymers containing PFAS or PFAC consisting of a 
CF3- or longer chain length from eligibility under the polymer 
exemption. This exclusion would be codified at 40 CFR 723.250(d)(6). 
EPA has received data on PFOS (a PFAS chemical containing a 
perfluoroalkyl moiety with eight carbon atoms) and PFOA (a PFAC 
chemical containing a perfluoroalkyl moiety with seven perfluorinated 
carbon atoms), that indicate that these chemicals are expected to 
persist and have the potential to bioaccumulate and be hazardous to 
human health and the environment. PFOS and PFOA have been found in the 
blood of workers exposed to the chemicals and in the general 
populations of the United States and other countries. They have also 
been found in many terrestrial and aquatic animal species worldwide. 
PFAS and PFAC chemicals 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 environmental 
distribution is uncertain.
    Animal test data for PFOS and PFOA have shown liver, developmental, 
and reproductive toxicity at very low exposure levels. Animal test data 
indicate that PFOA may cause cancer, and an epidemiologic study 
reported an increased incidence of bladder cancer mortality in a small 
number of workers at a plant that manufactures perfluorinated 
chemicals. The number of carbon atoms on the PFAS/PFAC component may 
influence the bioaccumulation potential and the toxicity. In 
particular, there is some 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 (Refs. 5, 6, and 7). Although there is insufficient 
understanding available at present to determine the carbon number below 
which PFAS and PFAC chemicals ``will not present an unreasonable 
risk,'' efforts are underway to develop a better understanding of the 
environmental fate, bioaccumulation potential, and human and 
environmental toxicity of PFAS and PFAC chemicals with shorter carbon 
chains. At this time, however, EPA can no longer conclude that polymers 
containing PFAS or PFAC will not present an unreasonable risk to human 
health or the environment. Therefore, this proposed amendment would 
exclude polymers containing PFAS or PFAC from eligibility for exemption 
from TSCA section 5(a)(1)(A) reporting requirements for new chemical 
substances.

B. Polymers Containing Fluorotelomers or Other Perfluoroalkyl Moieties

    EPA is also proposing to exclude from the polymer exemption rule 
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 polymers molecule. EPA has concerns with respect 
to the potential health and environmental effects of these substances 
and the Agency believes that polymers containing such moieties should 
be subject to the premanufacture review process so that EPA can better 
evaluate and address these concerns.
    As discussed in Unit IV.E., there is a growing body of data 
demonstrating that fluorotelomer alcohols metabolize or degrade to 
generate PFOA. Initial studies have also demonstrated toxic effects of 
certain compounds containing fluorotelomers (derived from the 8-2 
alcohol). Preliminary investigations have found that fluorotelomer 
alcohols were present in the air above several cities, indicating that 
these substances may be widely distributed and that air may be a route 
of exposure. EPA believes 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 
polymers molecule may degrade in the environment thereby releasing 
fluorotelomer alcohols or other perfluoroalkyl-containing substances. 
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'' 
as required for an exemption under section 5(h)(4) of TSCA. Therefore, 
EPA is proposing to exclude such polymers from the polymer exemption at 
40 CFR 723.250.

C. Proposed Implementation

    EPA is proposing to delay the implementation of the final rule in 
order to provide current manufacturers or importers of the affected 
polymers who are in full compliance with the terms of the existing 
polymer exemption rule, additional time to come into compliance with 
the amendment proposed without disrupting their ability to manufacture 
or import those polymers.
    To do this, EPA is proposing to establish an effective date for the 
final rule that is one year after the date of publication of the final 
rule. After expiration of the one year implementation period, polymers 
that

[[Page 11488]]

are subject to the final rule (including affected polymers made under 
the polymer exemption rule) would no longer be eligible for exemption. 
Therefore, a person who intends to manufacture or import polymers 
subject to the final rule must complete the TSCA premanufacture review 
process before the effective date. EPA believes that the one year 
period between the publication date of the final rule and the effective 
date of the final rule would provide adequate time for current 
manufacturers and importers of the polymers subject to the final rule 
to prepare and submit PMNs for those polymers and for EPA to review the 
PMNs.
    As an alternative to the one year effective date, EPA could 
establish an effective date of the final rule as 30 days after its 
publication in the Federal Register, the minimum required by section 
553(c) of the Administrative Procedure Act, but provide an extended 
compliance date for those who, prior to the effective date of the final 
rule, had already initiated the manufacture or import of polymers that 
are subject to the final rule. Under this approach, the TSCA section 
5(a)(1)(A) requirement to submit a PMN for a new chemical substance 
would be re-established with respect to polymers that are subject to 
the final rule, beginning 30 days after publication of the final rule 
in the Federal Register. However, those who are manufacturing or 
importing polymers under the existing exemption would have one year 
from the effective date to complete the PMN process. EPA is 
specifically requesting comment on this or other 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.

IV. Proposed Rule

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

    The 1995 amendments to the polymer exemption rule 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 chemicals, 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 PFOS in humans and 
animals (Refs. 12, 13, and 14). 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 
animals. 3M indicated that production of these chemicals would be 
substantially discontinued by the end of 2000 (Ref. 15). Based on this 
information from 3M, EPA began to investigate potential risks from PFOS 
and other perfluorinated chemicals, as well as polymers containing 
these chemicals. EPA believes that polymers containing PFAS or PFAC 
chemicals may degrade, releasing these chemicals 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. EPA 
also believes 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 substances into the environment 
where they may further degrade into PFAS or PFAC.

B. Defining Polymers That Are Subject to This Proposed Rule

    1. Polymers containing PFAS or PFAC. This proposed 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 of Chemical 
Substances compiled and published under section 8(b) of TSCA (15 U.S.C. 
2607(b)). For a list of examples of the Ninth Collective Index of 
chemical names and CAS Registry Numbers (CASRN) of chemical substances 
used to make polymers that are subject to this proposed rule amendment, 
see Ref.1. EPA has concerns for the perfluorinated carbon atoms in the 
Rf substituent, below, 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 proposed rule would specifically exclude 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 
(perfluorooctane sulfonate) 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.
    Most of the toxicity data currently available on PFAS and PFAC 
chemicals pertain to the PFOS potassium salt (PFOSK) and the PFOA 
ammonium salt

[[Page 11489]]

(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. 5, 6, and 7). 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.''
    2. Polymers containing fluorotelomers or other perfluoroalkyl 
moieties. EPA is also proposing to exclude 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.
    Fluorotelomers: One method that is commonly used to incorporate 
perfluorinated compounds into polymers is to use fluorotelomers, such 
as perfluoroalkyl ethanol. Telomerization is the reaction of a telogen 
with a polymerizable ethylenic compound to form low molecular weight 
polymeric compounds, commonly referred to as ``telomers.'' 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 can be further reacted to form a variety of useful 
materials which may subsequently be incorporated into the polymer (Ref. 
16). 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
    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

C. Concerns With Respect to Polymers Containing PFAS, PFAC, 
Fluorotelomers, or Other Perfluoroalkyl Moieties

    EPA is proposing to amend the polymer exemption rule because the 
Agency has received information which suggests that polymers containing 
certain perfluoroalkyl moieties consisting of a CF3- or longer chain 
length (i.e., 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) may 
degrade and release fluorochemical residual compounds into the 
environment. Once released, these substances are expected to persist in 
the environment, may bioaccumulate, and may be highly toxic. The 
evidence suggests that fluorotelomers and 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 do persist 
in the environment, and that they can be metabolically transformed into 
PFAC, which bioaccumulates and is toxic. The following sections will 
summarize the concerns the Agency has for 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.

D. Summary of Data on PFAS and PFAC

    1. Use and production volume data for PFOS. PFAS chemicals have 
been in commercial use since the 1950's. There were three main 
categories of use: Surface treatments, paper protectors (including food 
contact papers), and performance chemicals (Ref. 3). The various 
surface treatment and paper protection uses constituted the largest 
volume of PFOS production and therefore, were believed to present the 
greatest source of widespread human and environmental exposure to PFOS.
    Until the year 2000, 3M was the largest manufacturer of PFAS 
chemicals in the United States. On May 16, 2000, following discussions 
with the Agency, 3M issued a press release announcing that it would 
discontinue the production of perfluorooctanyl chemicals used in the 
manufacture of some of its repellent and surfactant products. In its 
statement, 3M committed to ``substantially phase out production'' by 
the end of calendar year 2000 (Ref. 17). In subsequent correspondence 
with the Agency, 3M provided a schedule documenting its complete plan 
for discontinuing all manufacture of specific PFOS and related 
chemicals for most surface treatment and paper protection uses 
(including food contact uses regulated by the Food and Drug 
Administration (FDA)) by the end of 2000, and for discontinuing all 
manufacture for any uses by the end of 2002 (Ref. 15).
    The 3M phase-out plan eliminated many of these chemicals from 
further distribution in commerce. The largest production volume (both 
initially produced and removed from commerce) was for polymers. Other 
PFAS chemicals, however, continue to be manufactured or imported by 
other companies and may be of concern. EPA followed the voluntary 3M 
phase-out with the promulgation of a SNUR under TSCA section 5. The 
SNUR limits any future manufacture or importation of PFOS before EPA 
has had an opportunity to review activities and risks associated with 
the proposed manufacture or importation (Ref. 17a).
    PFAS chemicals produced for surface treatment applications provide 
soil, oil, and water resistance to personal apparel and home 
furnishings. Specific applications in this use category include 
protection of apparel and leather, fabric/upholstery, and carpeting. 
Applications are undertaken in industrial settings such as textile 
mills, leather tanneries, finishers, fiber producers, and carpet 
manufacturers. PFAS chemicals are also used in aftermarket treatment of 
apparel and leather, upholstery, carpet, and automobile interiors, with 
the application performed by both the general public and professional 
applicators (Ref. 3). In 2000, the domestic production volume of PFAS 
chemicals for this use category was estimated to be 2.4 million pounds 
(Ref. 15).
    PFAS chemicals produced for paper protection applications provide 
grease, oil, and water resistance to paper and paperboard as part of a 
sizing agent formulation. Specific applications in this use category 
include food contact applications (plates, food containers, bags, and 
wraps) regulated by the FDA under 21 CFR 176.170, as well as non-food 
contact applications (folding cartons, containers, carbonless forms, 
and masking papers). The application of sizing agents is undertaken 
mainly by paper mills and, to some extent, converters, who manufacture 
bags, wraps, and other products from paper and paperboard (Ref. 3). In 
2000, the domestic production volume of PFOS chemicals for this use 
category was estimated to be 2.7 million pounds (Ref. 15).
    PFAS chemicals in the performance chemicals category are used in a 
wide variety of specialized industrial, commercial, and consumer 
applications. Specific applications include fire fighting foams, mining 
and oil well surfactants, acid mist suppressants for metal plating and 
electronic etching baths, alkaline cleaners, floor polishes, 
photographic film, denture cleaners,

[[Page 11490]]

shampoos, chemical intermediates, coating additives, carpet spot 
cleaners, and as an insecticide in bait stations for ants (Ref. 3). In 
2000, the domestic production volume of PFAS chemicals for this use 
category was estimated to be 1.5 million pounds (Ref. 15).
    2. Use and production volume data for PFOA. The largest use for 
PFOA is as a chemical intermediate. Its salts are used in emulsifier 
and surfactant applications, including as a fluoropolymer 
polymerization aid in the production of fluoropolymers and 
fluoroelastomers. This proposed rule does not require PMN notification 
for polymers where APFO is used exclusively as a polymerization aid and 
is not incorporated into the polymer structure.
    Until the year 2000, 3M was also the largest manufacturer and 
importer of PFOA and its salts in the United States. Subsequent to its 
May 16, 2000 announcement (see Unit IV.D.1.), 3M provided clarification 
that this announcement included PFOA as well as PFOS, indicating that 
it was phasing out certain FLUORAD Brand specialty materials that 
contained PFOA and its salts (Ref. 4). Following the phase-out by 3M, 
DuPont began to manufacture PFOA in the United States, and is currently 
the sole U.S. producer (Ref. 18). The Fluoropolymer Manufacturers Group 
has stated that DuPont will not sell APFO outside the fluoropolymer 
industry (Ref. 18a).
    The four principal use categories for salts of PFOA include uses 
as:
     A fluoropolymer polymerization aid in the industrial 
synthesis of fluoropolymers and fluoroelastomers such as 
polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF), with 
a variety of industrial and consumer uses (Refs. 19, 20, and 21).
     A post-polymerization processing aid to stabilize 
suspensions of fluoropolymers and fluoroelastomers prior to further 
industrial processing (Ref. 19).
     A processing aid for factory-applied fluoropolymer 
coatings on architectural fabrics, metal surfaces, and fabricated or 
molded parts (Ref. 20).
     An extraction agent in ion-pair reversed-phased liquid 
chromatography (Ref. 22).
    PTFE and PVDF account for the largest volumes of fluoropolymer 
production (Ref. 23). PFOA is also used in other fluoropolymer and 
fluoroelastomer manufacturing and processing. In addition, 3M used PFOA 
in the industrial synthesis of a fluoroacrylic ester, which is used in 
an industrial coating application (Ref. 19).
    The fluoropolymers manufactured with PFOA as a polymerization aid 
are used to produce a wide variety of industrial and consumer products. 
These products include: High performance lubricants; personal care 
products; architectural fabrics; films; cookware, breathable membranes 
for apparel; protective industrial coatings; wire and cable insulation; 
semiconductor chip manufacturing equipment; pump seals, liners and 
packing; medical tubing; aerospace devices; automotive hoses and 
tubing; and, a wide variety of electronic products (Ref. 24). The 
fluoropolymer industry has informed EPA that it does not intend to 
incorporate PFOA into the polymer structure for these uses (Ref. 24). 
However, if PFOA were to be incorporated into the structure of a 
polymer, this proposed rule amendment would require PMN notification.
    3. Exposure data for PFOS and PFOA. PFOS and PFOA have been 
detected at low levels in the blood of humans and wildlife throughout 
the United States, providing clear evidence of widespread exposure to 
these chemicals (Refs. 4 and 25). Studies are underway to determine the 
sources of exposure for PFOS and PFOA. Several potential pathways may 
account for the widespread exposure to these chemicals.
    For PFOS, these pathways may have included:
     Dietary intake from the consumption of food wrapped in 
paper containing PFOS derivatives.
     Inhalation from aerosol applications of PFOS-containing 
consumer products.
     Inhalation, dietary, or dermal exposures resulting from 
manufacturing, as well as industrial, commercial, and consumer use and 
disposal of PFOS-containing chemicals and products.
    Because PFOA is not used directly in consumer products, its 
exposure pathways may result from manufacturing and industrial uses and 
disposal of PFOA-derived chemicals and products, typically used as 
processing aids for fluoropolymer manufacturing. EPA has data 
indicating that PFOA is released into the environment from industrial 
discharges to air, water, and land (Refs. 19, 20, 26). Canadian 
research has found that thermolysis of fluoropolymers, e.g., PTFE, can 
liberate small quantities of perfluorocarboxylic acids, which include 
PFOA (Ref. 27). However, the extreme conditions needed to produce these 
PFAC products make this source of PFAC an improbable contributor to the 
environmental availability of PFAC.
    Data indicate that PFOA may also be produced by the degradation or 
metabolism of fluorotelomer alcohols (Refs. 8 and 48), suggesting 
exposures to PFOA may result from releases from fluorotelomer 
manufacturing and processing, and from the use and disposal of 
fluorotelomer-containing products.
    4. Environmental fate of PFAS and PFAC. Little information is 
available on the fate of high molecular weight PFAS and PFAC polymers 
in the environment. Based on their chemical structures they are 
expected to be stable, with many derivatives being non-volatile, but 
few studies are available to allow confirmation.
    EPA cannot currently conduct a definitive assessment of the 
environmental fate and transport of PFOS- and PFOA-derived chemicals. 
Conventional modeling programs are based on ``traditional'' organic 
compounds which contain carbon and hydrogen. These models are not 
designed to account for the physical-chemical properties and 
environmental behavior of perfluorinated compounds. Therefore, these 
models provide results that are not representative of perfluorinated 
chemicals.
    PFOS and PFOA may be expected to be similar in their resistance to 
hydrolysis, biodegradation and photolysis, however, they may have 
differences in adsorption/desorption, transport, distribution and 
bioaccumulation. Based on available data, PFOS and PFOA are expected to 
persist in the environment.
    PFOS and PFOA are stable to hydrolysis. The 3M Environmental 
Laboratory (Refs. 28 and 29) performed studies of the hydrolysis of 
PFOS and PFOA. The study procedures were based on EPA's OPPTS 
Harmonized Test Guideline 835.2110. Results were based on the observed 
concentrations of PFOS and PFOA in buffered aqueous solutions as a 
function of time. Based on these studies, it was estimated that the 
hydrolytic half-lives of PFOS and PFOA at 25[deg]C are greater than 41 
and 92 years, respectively.
    PFOS and PFOA do not measurably biodegrade in the environment. The 
biodegradation of PFOA was investigated using acclimated sludge 
microorganisms and a shake culture study modeled after the Soap and 
Detergent Association's presumptive test for degradation (Ref. 30). 
Neither thin-layer nor liquid chromatography detected the presence of 
any metabolic products over the course of 2 
1/89/21/13/23/85/83/8 months, indicating that PFOA does not 
readily undergo biodegradation. In a related study PFOA was not 
measurably degraded in activated sludge inoculum (Ref. 31). Several 
other studies conducted between 1977 to 1987 did

[[Page 11491]]

not show PFOA biodegradation either; however, the results are 
questionable due to methodological problems (Refs. 32, 33, 34, and 35). 
Similar results have been reported for PFOS. No measurable 
biodegradation of PFOS in activated sludge, sediment, aerobic soil, 
anaerobic sludge, or pure culture studies were found (Ref. 36).
    PFOS and PFOA appear to be stable to photolysis. Direct photolysis 
of PFOA was examined by Todd (Ref. 37) and photodegradation was not 
observed. Hatfield (Ref. 38) studied both direct and indirect 
photolysis utilizing techniques based on EPA and the Organization for 
Economic Cooperation and Development (OECD) guidance documents. There 
was no conclusive evidence of direct or indirect photolysis. A PFOA 
half-life in the environment was estimated to be greater than 349 days.
    PFOA appears to be mobile in soils, and there is conflicting data 
on the mobility of PFOS in soils. The adsorption-desorption of PFOA and 
PFOS were studied by 3M using 14C-labeled test chemicals in distilled 
water with a Brill sandy loam soil. The study reported a soil 
adsorption coefficient (Koc) of 14 for PFOA, and a 
Koc of 45 for PFOS, indicating that both PFOS and PFOA have 
high mobility in Brill sandy loam soil. The Koc value for 
PFOA, and possibly PFOS, however, is questionable due to the lack of 
accurate information on the purity of the 14C-labeled test substance 
(Refs. 39 and 40). In another 3M study using OECD method 106 to measure 
the sorption of PFOS (Ref. 41), it was reported that the chemical 
strongly adsorbed to all of the soil/sediment/sludge matrices tested. 
The test substance, once adsorbed, did not desorb readily, even when 
extracted with an organic solvent. Koc values more than 3 
orders of magnitude higher than those reported by Welsh were observed. 
DuPont evaluated PFOA in a soil absorption/desorption study and found 
that the average absorption of PFOA in various soils tested at 1:1 
soil:solution ratio ranged from 40.8% to 81.8%, and the highest average 
desorption coefficient (Kd) value, 22.5 mL/g, was found in 
sludge (Ref. 42). The data from the 3M and DuPont studies, while of 
high quality, are of limited utility in understanding the movement of 
PFOA released to soil. Batch sorption studies, because of their limited 
nature, do not provide all the information needed to understand the 
behavior of PFOA in the environment. The data raised additional 
questions, and are not sufficient to understand the behavior of PFOA in 
soil to allow EPA to determine whether soil is an important pathway for 
human and environmental exposure to PFOA.
    Both substances have low vapor pressures and Henry's Law constants 
(HLCs ), which suggest low potential for volatilization from water. The 
estimated HLCs for PFOS are 1.4 E-7, 2.4 E-8, 4.7 E-9 , 3 E-9 atm-m\3\/
mole (atmospheres per meter cubed per mole), utilizing the vapor 
pressure of 3.3 E-9 atm at 20[deg]C and water solubility values of 12, 
25, 370, and 570 (mg/L) in unfiltered seawater, filtered seawater, 
fresh water and pure water, respectively. For PFOA, the estimated HLCs 
is < 3.8 x 10E-10 atm-m\3\/mole based on a vapor pressure of 9.1 E-8 
atm and > 100 g/L solubility in water.
    Even though PFOS and PFOA have relatively low vapor pressures, it 
is possible that they can be adsorbed on suspended particles. This is 
because PFOS and PFOA are considered semi-volatile organic compounds, 
i.e., substances with vapor pressures between about 10 E-4 to 10 E-11 
atm at ambient temperatures (Ref. 43). The potential adsorption of PFOS 
and PFOA onto particulate matter might also create an exposure pathway.
    EPA believes that PFAS and PFAC chemicals may bioaccumulate, but is 
uncertain as to the mechanism. Three studies have been conducted that 
attempted to determine the bioaccumulation potential of PFOS and PFOA. 
In the first study using the fathead minnow, the calculated 
bioconcentration factor (BCF) was 1.8 for APFO (Ref. 46). However, 
questions were raised about the analytical techniques, high test 
chemical concentration and short test duration of the study. In a 
Japanese study using carp, the bioaccumulation potential of PFOA was 
low, with apparent bioaccumulation factors ranging from 3.1-9.1 (Ref. 
45). In the final study using bluegill sunfish from the 3M Decatur 
plant, no fluorochemicals were detected in the river water-exposed fish 
(Ref. 44). However, interpretation of the study was problematic. For 
instance, effluent concentrations of subject fluorochemicals were not 
characterized; the protocol for fish exposure was not found; there was 
no information on the Tennessee river water or effluent used, whether 
there was an opportunity for depuration of the fish prior to sacrifice, 
or the cause of death for the 12 dead fish; and the study did not 
differentiate between bioaccumulation of the test compound and sorption 
onto the fish surface. These studies in fish on the bioaccumulation of 
these chemicals suggest relatively low bioaccumulation potential. 
However, the detection of PFOS and to a lesser extent PFOA in wild 
animals indicates the possibility of accumulation of the chemicals in 
biota. PFOS and PFOA appear to have higher bioaccumulation factors than 
other PFAS and PFAC chemicals. Thus, the widespread presence of these 
chemicals in living organisms also suggests that PFOS and PFOA may 
bioaccumulate.
    5. Health effects of PFAS and PFAC. Most of the Agency's concerns 
for the health effects of polymers subject to this proposed rule focus 
on the perfluoroalkyl moiety, which may be released into the 
environment. The Agency's non-confidential data for health effects of 
PFAS and PFAC chemicals are on PFOS (as PFOSK) and PFOA (as APFO). EPA 
has insufficient evidence to determine that polymers containing PFAS or 
PFAC with any number of carbons on the perfluoroalkyl moiety ``will not 
present an unreasonable risk to human health or the environment'' and 
is proposing to exclude polymers that contain these chemicals from 
eligibility for the exemption. Below is a summary of the results of 
toxicological and epidemiological studies on PFOS and PFOA.
    i. Health effects of PFOS. All of the data summarized in Unit 
IV.D.5.i., as well as the primary references, are detailed in the OECD 
``Hazard Assessment of Perfluorooctane sulfonate (PFOS) and its Salts'' 
(Ref. 25).
    Toxicology studies show that PFOS is well absorbed orally and 
distributes primarily in the serum and liver. PFOS can also be formed 
as a metabolite of other perfluorinated sulfonates. It does not appear 
to be further metabolized. Elimination from the body is slow and occurs 
via both urine and feces. The elimination half-life for an oral dose is 
7.5 days in adult rats and approximately 200 days in Cynomolgus 
monkeys. In humans, the mean elimination half-life of PFOS reported in 
9 retired workers appears to be considerably longer, on the order of 
years (mean = 8.67 years; range = 2.29-21.3 years; standard deviation = 
6.12).
    PFOS has shown moderate acute toxicity by the oral route with a 
combined (male and female) rat LD50 of 251 mg/kg. The 
LD50 was 233 mg/kg in males and 271 mg/kg in females. A 1-
hour LC50 of 5.2 mg/L in rats has been reported. PFOS was 
found to be mildly irritating to the eyes and non-irritating to the 
skin of rabbits. PFOS does not induce gene mutation in selected strains 
of Salmonella typhimurium or Escherichia coli nor does it induce 
chromosomal aberrations in human lymphocytes in culture when tested in 
vitro either with or without metabolic activation. PFOS does not induce

[[Page 11492]]

 unscheduled DNA synthesis in primary cultures of rat hepatocytes and 
is negative when tested in vivo in a mouse bone marrow micronucleus 
assay.
    Three 90-day subchronic studies of PFOS have been conducted. One 
was a dietary study in rats and two were gavage studies in rhesus 
monkeys. In addition, a four week and a 26 week capsule study in 
Cynomolgus monkeys and a two-year cancer bioassay in rats, have been 
conducted . The primary health effects of concern, based on available 
data, are liver effects, developmental effects, and mortality. 
Mortality was associated with a steep dose-response across all ages and 
species.
    In the rat subchronic study, CD rats, 5/sex/group, were 
administered dietary levels of PFOS at 0, 30, 100, 300, 1,000 or 3,000 
parts per million (ppm) for 90 days. All of the rats in the 300, 1,000 
and 3,000 ppm groups died. Before death, the rats in all groups showed 
signs of toxicity including emaciation, convulsions following handling, 
hunched back, red material around the eyes, yellow material around the 
anogenital region, increased sensitivity to external stimuli, reduced 
activity, and moist red material around the mouth or nose. Mean body 
weight and average food consumption were reduced in all groups. Animals 
in the 100 ppm and 30 ppm dose groups also showed signs of 
gastrointestinal effects and hematological abnormalities. At necropsy, 
treatment related gross lesions were present in all treated groups and 
included varying degrees of discoloration and/or enlargement of the 
liver and discoloration of the glandular mucosa of the stomach. 
Histologic examination also showed lesions in all treated groups.
    Two 90-day rhesus monkey studies were performed. In the first 
study, PFOS was administered to male and female rhesus monkeys at doses 
of 0, 10, 30, 100, or 300 mg/kg/day in distilled water by gavage for 90 
days. In the second study, PFOS was administered at doses of 0, 0.5, 
1.5, or 4.5 mg/kg/day also in distilled water by gavage for 90 days. 
None of the monkeys in the first study survived treatment. In the 
second study, all monkeys in the 4.5 mg/kg/day group died or were 
sacrificed in extremis. Before death all monkeys suffered from similar 
signs of toxicity including decreased activity, emesis with some 
diarrhea, body stiffening, general body trembling, twitching, weakness, 
convulsions, and prostration. At necropsy, several of the monkeys in 
the 100 and 300 mg/kg/day groups had a yellowish-brown discoloration of 
the liver; histologic examination showed no microscopic lesions. 
Congestion, hemorrhage, and lipid depletion of the adrenal cortex was 
noted in all treated groups in the first study.
    In the second study, animals in the 30 mg/kg/day dose group had 
reduced mean body weight, significant reduction in serum cholesterol 
and a 50% reduction in serum alkaline phosphatase activity. At 
necropsy, all males and females had marked diffuse lipid depletion in 
the adrenals. One male and two females had moderate diffuse atrophy of 
the pancreatic exocrine cells with decreased cell size and loss of 
zymogen granules. Two males and one female had moderate diffuse atrophy 
of the serous alveolar cells characterized by decreased cell size and 
loss of cytoplasmic granules. Animals in the 1.5 and 0.5 mg/kg/day dose 
group survived to the end of the study and showed signs of decreased 
activity and gastrointestinal distress.
    Two additional studies were conducted in Cynomolgus monkeys. In the 
first study, male and female Cynomologus monkeys received doses of 0, 
0.02, or 2.0 mg/kg/day PFOS in capsules placed directly into the 
stomach for 30 days. All animals survived treatment. There were no 
test-related effects on clinical observations, body weight, food 
consumption, body temperatures, hematology, enzyme levels, cell 
proliferation in the liver, testes or pancreas or macroscopic or 
microscopic pathology findings.
    In the second study, PFOS was administered to Cynomolgus monkeys by 
oral capsule at doses of 0, 0.03, 0.15, or 0.75 mg/kg/day for 26 weeks. 
Animals from the 0.15 and 0.75 mg/kg/day groups were assigned to a 
recovery group and were held for observation for an additional 26 weeks 
after treatment. Two males in the 0.75 mg/kg/day dose group did not 
survive the 26 weeks of treatment. The first animal died on day 155. In 
addition to being cold to the touch, clinical signs in the first animal 
included: Constricted pupils, pale gums, gastrointestinal distress, low 
food consumption, hypoactivity, labored respiration, dehydration, and 
recumbent position. An enlarged liver was detected by palpation. Cause 
of death was determined to be pulmonary necrosis with severe acute 
inflammation. The second male was sacrificed in a moribund condition on 
day 179. Clinical signs noted included low food consumption, excessive 
salivation, labored respiration, hypoactivity and ataxia. The cause of 
death was not determined. Males and females in the 0.75 mg/kg/day dose-
group had lower total cholesterol and males and females in the 0.15 and 
0.75 mg/kg/day groups had lower high density lipoprotein cholesterol 
during treatment. The effect on total cholesterol worsened with time. 
By day 182, mean total cholesterol for males and females in the high 
dose group were 68% and 49% lower, respectively, than levels in the 
control animals. Males in the high dose group also had lower total 
bilirubin concentrations and higher serum bile acid concentrations than 
males in either the control or other treatment groups. The effect on 
total cholesterol was reversed within 5 weeks of recovery and the 
effect on high density lipoprotein cholesterol was reversed within 9 
weeks of recovery.
    At terminal sacrifice, females in the 0.75 mg/kg/day dose-group had 
increased absolute liver weight, liver-to-body weight percentages, and 
liver-to-brain weight ratios. In males, liver-to body weight 
percentages were increased in the high-dose group compared to the 
controls. ``Mottled'' livers and centrilobular or diffuse 
hepatocellular hypertrophy and centrilobular or diffuse hepatocellular 
vacuolation were also observed in high dose males and females. No PFOS 
related lesions were observed either macroscopically or microscopically 
at recovery sacrifice indicating that the effects seen at terminal 
sacrifice may be reversible.
    The chronic toxicity and carcinogenic