[Federal Register Volume 68, Number 73 (Wednesday, April 16, 2003)]
[Notices]
[Pages 18626-18633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9418]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPT-2003-0012; FRL-7303-8]


Perfluorooctanoic Acid (PFOA), Fluorinated Telomers; Request for 
Comment, Solicitation of Interested Parties for Enforceable Consent 
Agreement Development, and Notice of Public Meeting

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  EPA has identified potential human health concerns from 
exposure to perfluorooctanoic acid (PFOA) and its salts, although there 
remains considerable scientific uncertainty regarding potential risks. 
EPA is requesting public comment on pertinent topics of interest, as 
discussed in this document, and the submission of additional data 
concerning these chemicals. EPA is also soliciting the identification 
of interested parties who want to monitor or participate in 
negotiations on one or more enforceable consent agreements (ECAs) under 
section 4 of the Toxic Substances Control Act (TSCA) concerning PFOA 
and fluorinated telomers which may metabolize or degrade to PFOA, and 
is announcing the first public meeting for these ECA negotiations.

DATES:  Comments on this notice must be received on or before May 16, 
2003.
    Notify EPA in writing on or before May 16, 2003 of your desire to 
be accorded ``interested party'' status for the purpose of 
participating in or monitoring the negotiations for development of ECAs 
concerning PFOA and telomers.
    A public meeting has been scheduled to initiate negotiations on an 
ECA for PFOA and telomers, from 1 p.m. to 5 p.m., on Friday, June 6, 
2003.

ADDRESSES:  Submit your comments, identified by docket ID number OPPT-
2003-0012, online at http://www.epa.gov/edocket/ (EPA's preferred 
method), or by mail to EPA Docket Center (7407), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. For additional comment submission methods and detailed 
instructions, go to Unit I.C. of the SUPPLEMENTARY INFORMATION.
    Submit your notification for ``interested party'' status separately 
from any comments submitted, identified ``Attention: PFOA ECA 
Notification'' by mail to Brigitte Farren, Chemical Control Division 
(7405M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. To protect personal information from disclosure to the public, 
please submit these notifications separately from your comments and do 
not use any online electronic commenting system to submit this 
notification.
    The public meeting to initiate negotiations on ECAs for PFOA and 
telomers will be held at the Environmental Protection Agency, EPA East 
Bldg., Rm. 1153, 1201 Constitution Ave., NW., Washington, DC.

FOR FURTHER INFORMATION CONTACT:  For general information contact: 
Barbara Cunningham, Director, 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: [email protected].
    For technical information contact: Mary Dominiak, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8104; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of 
particular interest to manufacturers, importers, processors, exporters, 
distributors, and users of PFOA, fluoropolymers, fluoroelastomers, and 
telomer chemicals. Since other entities may also be interested, the 
Agency has not attempted to describe all the specific entities that may 
be affected by this action. 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. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPPT-2003-0012. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the EPA Docket Center, Rm. 
B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, 
DC. Additional information concerning the topics discussed in this 
notice can be found in Administrative Record (AR)-226: PFOS, PFOA, 
Telomers, and Related Chemicals, which was established by the Agency in 
2000 to receive information on various fluorinated chemicals, including 
PFOA. These materials are also available in the EPA Docket Center. The 
EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The EPA Docket Center Reading Room 
telephone number is (202) 566-1744 and the telephone number for the 
OPPT Docket, which is located in EPA Docket Center, is (202) 566-0280.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other

[[Page 18627]]

information whose disclosure is restricted by statute, which is not 
included in the official public docket, will not be available for 
public viewing in EPA's electronic public docket. EPA's policy is that 
copyrighted material will not be placed in EPA's electronic public 
docket but will be available only in printed, paper form in the 
official public docket. To the extent feasible, publicly available 
docket materials will be made available in EPA's electronic public 
docket. When a document is selected from the index list in EPA Dockets, 
the system will identify whether the document is available for viewing 
in EPA's electronic public docket. Although not all docket materials 
may be available electronically, you may still access any of the 
publicly available docket materials through the docket facility 
identified in Unit I.B.1. EPA intends to work towards providing 
electronic access to all of the publicly available docket materials 
through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and To Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. (Please note, however, that to protect personal 
information from disclosure to the public, you should not follow the 
instructions in this section to submit your notification for 
``interested party'' status. Such notification should be submitted 
separately from any comments on this document using the specific 
instructions provided under ADDRESSES. Do not use any online electronic 
commenting system to submit this notification.) To ensure proper 
receipt by EPA, identify the appropriate docket ID number in the 
subject line on the first page of your comment. Please ensure that your 
comments are submitted within the specified comment period. Comments 
received after the close of the comment period will be marked ``late.'' 
EPA is not required to consider these late comments. If you wish to 
submit CBI or information that is otherwise protected by statute, 
please follow the instructions in Unit I.D. Do not use EPA Dockets or 
e-mail to submit CBI or information protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. 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.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPPT-2003-0012. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPPT-2003-0012. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Document Control Office (7407M), 
Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    3. By hand delivery or courier. Deliver your comments to: OPPT 
Document Control Office (DCO) in EPA East Bldg., Rm. 6428, 1201 
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number 
OPPT-2003-0012. 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.

D. How Should I Submit CBI To the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
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 CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any 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 and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI,

[[Page 18628]]

please consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    We invite you to provide your views on the various options we 
propose, new approaches we have not considered, the potential impacts 
of the various options (including possible unintended consequences), 
and any data or information that you would like the Agency to consider 
during the development of the final action. You may find the following 
suggestions helpful for preparing your comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice or collection 
activity.
    7. Make sure to submit your comments by the deadline in this 
notice.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has prepared a preliminary risk assessment (Ref. 1) on 
perfluorooctanoic acid (PFOA) (Octanoic acid, pentadecafluoro-; 
Chemical Abstracts Service Registry Number (CAS No.) 335-67-1) and its 
salts, predominantly ammonium perfluorooctanoate (APFO) (Octanoic acid, 
pentadecafluoro-, ammonium salt (CAS No. 3825-26-1)). This preliminary 
assessment indicates potential nationwide human exposure to low levels 
of PFOA. Based on certain animal studies, there could be a potential 
risk of developmental and other adverse effects associated with these 
exposures in humans. However, this assessment also reflects substantial 
uncertainty about the interpretation of the risk. EPA has identified 
areas where additional information could be very helpful in allowing 
the Agency to develop a more accurate assessment of the potential risks 
posed by PFOA and the other compounds addressed in this notice, and to 
identify what voluntary or regulatory mitigation or other actions, if 
any, would be appropriate. EPA is making this preliminary assessment 
public in order to identify the Agency's concerns, to indicate areas 
where additional information or investigation would be useful, and to 
request the submission of data addressing these issues.
    EPA is also soliciting the identification of parties who would be 
interested in monitoring or participating in negotiations for the 
development of one or more ECAs under section 4 of TSCA on PFOA and on 
fluorinated telomers (hereafter ``telomers'') which may metabolize or 
degrade to PFOA. The intent of the ECAs would be to develop additional 
information, particularly environmental fate and transport information, 
to enhance understanding of the sources of PFOA in the environment and 
the pathways by which human exposure to PFOA is occurring.

III. Background

    In 1999, EPA began an investigation after receiving data on 
perfluorooctyl sulfonate (PFOS) indicating that PFOS was persistent, 
unexpectedly toxic, and bioaccumulative. These data also showed that 
PFOS had been found in very low concentrations in the blood of the 
general population and in wildlife around the world. 3M Company (3M), 
the sole manufacturer of PFOS in the United States and the principal 
manufacturer worldwide, announced in May 2000 that it was discontinuing 
its perfluorooctanyl chemistries, including PFOS. EPA followed the 
voluntary 3M phaseout with regulatory action under TSCA section 5 to 
limit 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. 2).
    In June 2000, EPA indicated that it was expanding its investigation 
of PFOS to encompass other fluorochemicals, including PFOA, in order to 
determine whether these other fluorochemicals might present concerns 
similar to those found with PFOS. EPA was concerned in part because 3M 
had also found PFOA in human blood during the studies on PFOS (Ref. 3).
    In September 2002, the Director of OPPT initiated a priority review 
on PFOA because the developmental toxicity data, the carcinogenicity 
data, and the blood monitoring data presented in an interim revised 
hazard assessment raised the possibility that PFOA might meet the 
criteria for consideration under TSCA section 4(f) (Refs. 4 and 5). 
When the priority review commenced, EPA anticipated completing the 
review within a few months. However, as explained in this notice, there 
remain substantial uncertainties associated with the preliminary risk 
assessment. EPA believes these uncertainties may be reduced through 
acquisition of the information described in this notice. EPA is 
therefore continuing the priority review in order to acquire this 
information and better inform the Agency's decisionmaking.

A. PFOA Sources and Uses

    PFOA and its salts are fully fluorinated organic compounds that can 
be produced synthetically and formed through the degradation or 
metabolism of certain other manmade fluorochemical products. PFOA is a 
synthetic chemical and is not naturally occurring. Consequently, all 
PFOA in the environment is attributable to human activity.
    PFOA is used primarily to produce its salts, which are used as 
essential processing aids in the production of fluoropolymers and 
fluoroelastomers. Although they are made using PFOA, finished 
fluoropolymer and fluoroelastomer products are not expected to contain 
PFOA. In recent years, less than 600 metric tons per year of PFOA and 
its salts have been manufactured or imported in the United States (Ref. 
6). The major fluoropolymers manufactured using PFOA salts are 
polytetrafluoroethylene (PTFE) and polyvinylidine fluoride (PVDF). PTFE 
has hundreds of uses in many industrial and consumer products, 
including soil, stain, grease, and water resistant coatings on textiles 
and carpet; uses in the automotive, mechanical, aerospace, chemical, 
electrical, medical, and building/construction industries; personal 
care products; and non-stick coatings on cookware. PVDF is used 
primarily in three major industrial sectors: Electrical/electronics, 
building/construction, and chemical processing.
    PFOA can be commercially manufactured by two major alternative 
processes: The Simons Electro-Chemical Fluorination (ECF) process, and 
a telomerization process. Releases from manufacturing processes are one 
source of PFOA in the environment. Historically, most U.S. production 
was by 3M using the ECF process. 3M discontinued its manufacture of 
PFOA between 2000 and 2002, and other domestic producers are using the 
telomerization process exclusively.
    In the ECF process, an electric current is passed through a 
solution of anhydrous hydrogen fluoride and an organic feedstock of 
octanoic acid or a derivative. The ECF process replaces the

[[Page 18629]]

carbon-hydrogen bonds on molecules of the organic feedstock with 
carbon-fluorine bonds. Perfluorination occurs when all the carbon-
hydrogen bonds are replaced with carbon-fluorine ones. The ECF process 
yields between 30-45% straight chain (normal) perfluorooctanonyl 
fluoride (PFOF), along with a variable mixture of byproducts and 
impurities. The output of the ECF process consists of a complex 
combination of chemical substances with varying molecular weights, 
including higher and lower straight-chain homologues; branched-chain 
perfluoroalkyl fluorides of various chain lengths; straight-chain, 
branched, and cyclic perfluoroalkanes and ethers; and other byproducts. 
After disposal or recovery of some of the byproducts and impurities, 
the acid fluoride is base hydrolyzed in batch reactors to yield PFOA. 
The PFOA salts are synthesized by base neutralization of the acid to 
the salt in a separate reactor.
    In the telomerization process, tetrafluoroethylene is reacted with 
other fluorine-bearing chemicals to yield fluorinated intermediates 
which are readily converted into PFOA. This process yields 
predominantly straight-chain acids with an even number of carbon atoms. 
Distillation can be used to obtain pure components. Commercial products 
manufactured through the telomerization process, sometimes known as 
telomers, are generally mixtures of perfluorinated compounds with even 
carbon numbers, although the process can also produce compounds with 
odd carbon numbers.
    In addition to releases from the deliberate manufacture of PFOA 
through either the ECF or telomerization processes, and from the use of 
PFOA and its salts in the manufacture and processing of fluoropolymers 
and fluoroelastomers, PFOA may have entered the environment through 
other sources. 3M has indicated that PFOA may have been present as a 
trace contaminant in some of the fluorochemical products which it 
discontinued manufacturing between 2000 and 2002 (Ref. 7). Because 
these products are no longer being manufactured, they will likely not 
be a significant potential future source of PFOA.
    EPA has also received data which indicate that the 8-2 telomer 
alcohol (1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
heptadecafluoro- (CAS No. 678-39-7)) although not itself made with 
PFOA, can be metabolized by living organisms or biodegrade under 
environmental conditions to produce PFOA (Refs. 8 and 9). Other telomer 
chemicals have not been tested to determine whether they may also 
metabolize or degrade to form PFOA. Telomers are used widely in a range 
of commercial products, including some that are directly released into 
the environment, such as fire fighting foams, as well as soil, stain, 
and grease resistant coatings on carpets, textiles, paper, and leather. 
The extent to which these telomer-containing products might degrade to 
release PFOA is unknown. However, anecdotal evidence of the atmospheric 
presence of telomer alcohols in a multi-city North American survey 
suggests that telomers may be one source of environmental PFOA (Ref. 
10). Additional fate information is necessary to determine whether and 
the extent to which telomer product degradation may be a source of 
PFOA.
    EPA is not currently aware of any other potential sources of PFOA 
in the environment. EPA specifically requests comment on this issue, 
and the submission of any data identifying or characterizing PFOA 
sources. EPA is especially interested in the thermal stability and 
oxidative degradation products of materials containing PFOA or telomer 
chemicals which are incinerated.

B. Hazard and Exposure

    EPA has conducted a detailed review of all available hazard and 
exposure information on PFOA. This review is available in the Agency's 
Revised Draft Hazard Assessment on PFOA and Its Salts (Ref. 11). This 
draft hazard assessment has not been formally peer reviewed, but has 
been reviewed internally by the EPA Office of Research and Development 
(ORD).
    PFOA is persistent in the environment. It does not hydrolyze, 
photolyze, or biodegrade under environmental conditions. Based on 
recent human biomonitoring data provided by industry, which found PFOA 
in the blood of workers and the general population in all geographic 
regions of the United States, exposure to PFOA is potentially 
nationwide, although the routes of exposure for the general population 
are unknown.
    Several epidemiological studies on the effects of PFOA in humans 
have been conducted on workers. An association with PFOA exposure and 
prostate cancer was reported in one study; however, this result was not 
observed in an update to the study in which the exposure categories 
were modified. A non-statistically significant increase in the levels 
of the hormone estradiol in workers with high serum PFOA levels (>30 
parts per million (ppm)) was also reported, but none of the other 
hormone levels analyzed indicated any adverse effects.
    APFO is the most widely used salt of PFOA, and most animal toxicity 
studies have been conducted with APFO. An extensive array of animal 
toxicity studies have been conducted in rodents and monkeys. These 
studies have shown that APFO exposure can result in a variety of toxic 
effects in animals including liver toxicity, developmental toxicity, 
and immunotoxicity. In addition, rodent bioassays have shown that 
chronic APFO exposure is associated with a variety of tumor types. The 
mechanisms of APFO tumorigenesis are not clearly understood. At this 
time, EPA is evaluating the scientific evidence and has not reached any 
conclusions on the potential significance to humans of the rodent 
cancer data.
    There are marked gender differences in the elimination of PFOA in 
rats. In addition, there are substantial differences in the half-life 
of PFOA in rats, monkeys, and humans. The gender and species 
differences are not completely understood and therefore the extent of 
potential risks to humans is uncertain.

C. Preliminary Risk Assessment

    Because TSCA section 4(f) is focused narrowly on the specific 
toxicity endpoints of cancer, birth defects, and gene mutation, the 
preliminary risk assessment prepared as part of this priority review 
focused on the potential risks for developmental toxicity in humans. 
EPA did not include cancer risk in this preliminary assessment due to 
questions concerning the potential significance to humans of the rodent 
cancer data. Because data indicate that PFOA is not mutagenic, concern 
for gene mutation was not an issue for this preliminary assessment.
    The preliminary risk assessment used a margin of exposure (MOE) 
approach (Ref. 1). For many risk assessments, the MOE is calculated as 
the ratio of the administered dose from the animal toxicology study to 
the estimated human exposure level. The human exposure is estimated 
from a variety of potential exposure scenarios, each of which requires 
a variety of assumptions.
    A more accurate estimate of the MOE can be derived if measures of 
internal dose are available for humans and the animal model. In this 
preliminary risk assessment, serum levels of PFOA, which are a measure 
of internal dose, were available for some administered dose levels in 
the rat 2-generation reproductive toxicology study and from human 
biomonitoring studies. Thus, internal dose was used for the

[[Page 18630]]

calculation of MOEs in this assessment. The actual values of the MOEs 
derived must be viewed with caution, however, due to the differences in 
kinetics between humans and rodents. The range of MOEs in the 
preliminary assessment encompasses some values that would indicate 
potential concern and other values that would indicate a low level of 
concern. Due to the uncertainties in the assessment, and the 
possibility that the additional information discussed in this notice 
might reduce those uncertainties, the Agency has not attempted further 
interpretation of these MOEs at this time. The interpretation of the 
significance of the MOEs for ascertaining potential levels of concern 
will necessitate a better understanding of the appropriate dose metric 
in rats, and the relationship of the dose metric to the human serum 
levels.
    As this priority review of PFOA progresses, EPA will continue to 
develop the characterization of hazard and potential risk associated 
with exposure to PFOA. Because the scientific interpretation issues in 
this case are particularly complex, given the unusual properties and 
behavior of PFOA and the absence of data on exposure pathways and 
levels, EPA anticipates that a more comprehensive risk analysis will be 
taken to the Agency's Science Advisory Board for review and comment in 
fall 2003. The preliminary risk assessment described in this notice has 
not been formally peer reviewed, but has gone through internal review 
by multiple EPA offices, including ORD, the Office of Science 
Coordination and Policy (OSCP), the Office of Pesticide Programs (OPP), 
and the Office of Policy, Economics, and Innovation (OPEI). The 
preliminary risk assessment has also been the subject of an external 
letter peer review.

D. Uncertainties and Data Needs

    Although EPA has concerns with respect to the potential nationwide 
presence of PFOA in blood and with the potential for developmental and 
other effects suggested by animal studies, there are significant 
uncertainties in the Agency's quantitative assessment of the risks of 
PFOA. In addition, the uncertainties discussed in this unit with 
respect to the identification of the pathway or pathways that result in 
human exposure to PFOA (air, water, food, etc.), and the uncertainties 
associated with how PFOA gets into those pathways (including the 
products or processes that are responsible for the presence of PFOA in 
the environment) make it difficult to determine what, if any, 
particular risk mitigation measures would be appropriate. The Agency 
believes that the additional information identified in this notice 
would better inform this priority review and Agency decisionmaking with 
respect to PFOA.
    The sources of PFOA in the environment, as described in Unit II.A., 
are not fully defined or understood. Historically, direct PFOA releases 
during the manufacture of PFOA and its use in the manufacture and 
processing of fluoropolymers and fluoroelastomers have been quantified 
at some sites. Industry has identified and implemented voluntary 
control technologies to reduce releases, as well as to improve PFOA 
recovery for recycling or destruction, as described in Unit II.E. The 
effectiveness of these programs could be assessed, possibly through the 
ECA process described in Unit V., by monitoring PFOA levels at the 
respective facilities and determining if the release reduction and 
waste management programs are reducing the PFOA levels in the media 
surrounding the affected facilities. PFOA exposures and releases to the 
environment may also come from the distribution of PFOA in aqueous 
dispersions of fluoropolymers used by processors to apply coatings to 
metals and textiles, a topic which industry is also attempting to 
resolve.
    In addition, the question of the potential contribution to PFOA 
levels from telomer manufacture and from telomer product degradation 
remains. The universe of specific telomer chemicals that may ultimately 
degrade or metabolize to PFOA has not been fully defined. Preliminary 
data suggest that only higher perfluorinated homologues (chemicals with 
carbon chain lengths of eight and higher) would be converted into PFOA 
via normal environmental pathways. The 8-2 telomer alcohol has been 
shown to biodegrade and metabolize to form PFOA, but other telomer 
chemicals, including telomer iodides and telomer-derived polymers, have 
not yet been tested. Determining possible telomer product sources of 
PFOA may be particularly difficult because these fluorochemicals are 
typically used in products in very low concentrations, indicating that 
any individual source contribution by specific products could be very 
small, widely distributed, and difficult to detect. For example, 
products contaminated with volatile, unreacted telomer alcohol 
residuals could potentially release those residuals into the 
environment where they could be subject to biodegradation.
    The exposure routes leading to the presence of PFOA in human blood 
are not known. The nationwide presence of PFOA in human blood, 
contrasted with the limited geographic locations of fluorochemical 
plants making or using the chemical, suggests that there must be 
additional sources of PFOA in the environment, and exposures beyond 
those attributable to direct releases from industrial facilities. But 
whether these exposures are due to PFOA in the air, the water, on dusts 
or sediments, in dietary sources, or through some combination of routes 
is currently unknown. Data evaluating the environmental presence of 
PFOA in water are very limited and site-specific. Data on the presence 
of PFOA in air or soil are not currently available. Data on the 
presence of PFOA in wildlife suggest that animals are not as likely as 
humans to have PFOA in their blood, and that PFOA is not found as 
widely in animals as PFOS. Whether these differences may be due to 
different exposure pathways or to differences in how the chemicals are 
processed or retained by animals and humans is unknown. The technical 
difficulties of detecting and accurately measuring the chemical in all 
these various media, particularly in the low concentrations that EPA 
would anticipate, are considerable.
    The preliminary risk assessment on potential developmental toxicity 
was based on a comparison of serum levels in the 2-generation rat 
reproductive study with those found in the human population. However, 
there are considerable species differences in the kinetics of PFOA. 
Interpretation of the significance of the MOEs for ascertaining 
potential levels of concern will necessitate a better understanding of 
the appropriate dose metric in rats, and the relationship of the dose 
metric to the human serum levels.
    Finally, there are some uncertainties regarding the use of the 
human biomonitoring data. Although the available data include a range 
of populations with various demographics in many States and all 
geographic areas of the country, there may be some populations that are 
not represented. Because it is unknown how the human exposures are 
occurring, proximity to a manufacturing facility may or may not be a 
factor in exposure. However, populations living near these facilities 
were not sampled. Therefore, it is possible that PFOA serum levels may 
be underestimated for certain portions of the U.S. population. The 
children's sample was derived from blood collected in 1994/1995; 
therefore, it may not reflect the current status of PFOA in children's 
blood.
    Voluntary activities by industry are underway as described in Unit 
II.E. to help address some of these uncertainties

[[Page 18631]]

and data gaps. For example, pharmacokinetics studies examining the 
biological processing of PFOA in rats are expected to be completed in 
the summer and fall of 2003. These studies may help to reduce the 
uncertainty in the estimation of risk to humans. In addition, EPA has 
submitted a nomination to the Centers for Disease Control and 
Prevention (CDC) to include PFOS, PFOA, and certain related 
fluorochemicals in the next National Health and Nutrition Examination 
Survey (NHANES). This would provide a national baseline of PFOA 
exposure, both to indicate whether current data are representative of 
the U.S. population and to offer a gauge with which to measure the 
effectiveness of actions to reduce exposures.
    EPA will continue to develop and clarify issues relating to hazard, 
exposure, and risk as the priority review continues and the Agency 
receives additional information that allows further resolution of the 
uncertainties identified in this unit.
    Additional data beyond EPA's current activities and the voluntary 
efforts undertaken by the industry may be necessary to resolve the 
existing uncertainties and fill remaining data gaps, including gaps not 
yet identified. EPA requests comment on these issues, and particularly 
requests that comments include the submission of any additional data 
that may help to fill these gaps. Certain specific information requests 
are identified in Unit IV.

E. Ongoing Voluntary Activities

    In 2000, EPA opened a non-regulatory public docket file, 
Administrative Record AR-226, for information on PFOS, PFOA, telomers, 
and related fluorinated chemicals, and began to express its concerns to 
the global fluorochemical industry (Ref. 3). In response, the industry 
began providing information to the Agency, all of which has been placed 
into AR-226. Two industry groups, the Fluoropolymer Manufacturing Group 
(FMG) and the Telomer Research Program (TRP), formed and began pursuing 
voluntary collective actions to address issues associated with PFOA and 
the telomers. 3M continued its ongoing research efforts despite having 
discontinued the manufacture of both PFOS and PFOA. Much of the 
information reflected in the EPA's revised draft hazard assessment and 
preliminary risk assessment on PFOA was provided through these 
voluntary activities on the part of industry.
    In March 2003, EPA received letters from 3M, FMG, and TRP 
documenting their ongoing voluntary programs and outlining their plans 
for continuing research and product stewardship activities (Refs. 7, 
12, and 13). These letters have been placed in the public docket for 
this notice and can be accessed as described in Unit I.B.2. The letters 
contain substantial additional information concerning the specifics of 
the voluntary industry actions beyond what is presented in this notice.
    In its letter, 3M indicated that it would not resume the 
manufacture of PFOA for commercial sale; that it would continue its 
medical monitoring efforts for workers and provide biannual reports to 
EPA and update its epidemiological study reports to EPA every 5 years; 
and that it will continue monitoring groundwater, surface water, and 
other environmental media and provide a summary report to EPA within 2 
years. 3M also stated that it would work with other members of industry 
to conduct additional validation of PFOA analytical methods and 
sampling protocols and to participate in human health and environmental 
fate and effects studies of PFOA. 3M also indicated that the facilities 
and employees of its subsidiary, Dyneon LLC, would continue to be part 
of the 3M monitoring program.
    The members of the FMG--Asahi Glass Fluoropolymers USA, Inc.; 
Daikin America, Inc.; E.I. duPont de Nemours & Company; and Dyneon 
LLC--indicated that they and their parent companies represent most of 
the known use of APFO for the production of fluoropolymers both in the 
United States and worldwide. Their letter includes commitments to 
reduce emissions of APFO from fluoropolymer and APFO manufacturing 
facilities on a global, individual company-wide basis by a minimum of 
50% by 2006; to conduct studies on both finished polymers and finished 
products from these polymers to determine if any exposure to the 
general population can be related to the fluoropolymer industry; to 
conduct studies on emissions from fluoropolymer processing facilities 
to determine the level of current emissions; and to develop additional 
toxicological data on APFO. The companies noted that they are 
participating in activities through the Association of Plastics 
Manufacturers in Europe (APME) to conduct pharmacokinetics studies in 
rats and develop a pharmacokinetic model, and would share those data 
with EPA as they are developed, beginning in spring 2003. The companies 
indicated that they would continue to follow principles of product 
stewardship similar to those described in the Responsible Care[reg] 
programs of the American Chemistry Council and the Synthetic Organic 
Chemical Manufacturers Association in their efforts to support 
toxicological research, control occupational exposures in their own 
facilities, monitor employee health, assist customers in protecting 
their employees, and meet the general commitment to reduce emissions to 
the environment. The companies stated that they will continue to use 
appropriate criteria, including such standards as the interim air and 
water screening levels and water quality guidelines recently adopted in 
West Virginia, to evaluate operations and emissions (Refs. 14 and 15). 
The letter includes a schedule for the completion of various studies 
already underway.
    The members of the TRP--AGA Chemicals (Asahi Glass); Clariant GmbH; 
Daikin America, Inc.; and E.I. duPont de Nemours & Company--indicated 
that they comprise the major telomer producers, and that they are 
evaluating telomer products sold in the United States to determine 
whether they contribute to significant human or environmental exposure 
to PFOA. They noted that their evaluation has six key components: 
Analysis of products and articles; analysis of ``aged'' products and 
``in use'' articles; characterization of potential release of PFOA from 
telomer-based product manufacture; characterization of potential 
release of PFOA from telomer-treated article manufacture; analysis of 
possible biodegradation of telomer-based polymeric products; and 
evaluation of the ultimate fate and disposal routes for telomer-treated 
articles in the United States. The letter includes lists and schedules 
for these various evaluation components, as well as for the submission 
of additional information to the Agency.
    EPA appreciates the industry response to the Agency's concerns 
regarding PFOA and the telomers, and looks forward to continued 
cooperation on assessment and management activities. EPA invites the 
participation of additional interested persons in these efforts. EPA 
considers that the timely submission of the information which industry 
has already committed to provide will be essential to developing a 
better and more complete understanding of the potential risks of PFOA. 
However, in light of the concerns identified to date, the Agency will 
continue its ongoing expeditious review.
    While the voluntary industry activities as described in the letters 
will provide substantial additional information, EPA considers it 
likely that

[[Page 18632]]

issues will remain even after these activities are complete, and that 
the results of some of these programs may well identify additional 
questions that will need to be answered. EPA requests comment on these 
issues.

IV. Specific Requests for Comments, Data, and Information

    EPA specifically requests comments, data, and information on the 
following topics.

A. Use and Production Volume Information

    What are the specific chemical identities (by Ninth Collective 
Index name and CAS No., if available) of the telomer chemicals, 
including polymers derived from these telomers, and of the 
fluoropolymers and fluoroelastomers made with PFOA or related 
chemicals, currently in commerce? In what volumes and at what locations 
are these chemicals manufactured or imported? How and in what volumes 
are these chemicals used? What are the benefits of these chemicals and 
products in their specific uses, and what alternatives to these 
chemicals may be available for specific uses?

B. Exposure Information

    How are products containing the chemicals identified in Unit IV.A. 
used? How are these products disposed of? What environmental releases 
occur at manufacturing and processing facilities where these chemicals 
are used? What data are available on worker exposures to these 
chemicals? What data are available on exposures to the general 
population? What data are available on measured levels of these 
chemicals in humans and the environment, in all environmental media? 
What data are available on the biodegradation of these chemicals, on 
releases of these chemicals from consumer and industrial products, and 
on their breakdown during product biodegradation, incineration, and 
other disposal practices?

C. Monitoring and Related Information

    EPA specifically requests that any persons who have in their 
possession existing human or environmental monitoring data indicating 
or assessing the presence of PFOA and related fluorochemicals in 
humans, in wildlife, or in any environmental media, including studies 
conducted in other countries, provide those data to the Agency in 
response to the publication of this notice to enhance the understanding 
of PFOA presence in the environment and of the pathways leading to 
exposures. EPA includes in this request any existing data not otherwise 
provided to EPA concerning the toxicity, pharmacokinetics, and half-
life of PFOA in organisms.

D. Additional Data

    Are there other pieces of information not addressed in Unit IV. A., 
B., and C., that would help EPA more accurately assess the risks of 
these chemicals and determine appropriate further action, if warranted?

V. Enforceable Consent Agreement Development

    EPA is interested in developing one or more ECAs under TSCA section 
4 and 40 CFR part 790 for PFOA and telomers that focus on identifying 
environmental fate and transport information, as well as other relevant 
information to enhance understanding of the sources of PFOA in the 
environment and the pathways by which human exposure to PFOA is 
occurring. The objective of the ECA process is to conclude one or more 
ECAs that will set in place an industry-sponsored testing program that 
will address a number of EPA's current data needs for PFOA and 
telomers. EPA expects that industry will meet the voluntary testing 
commitments made in their letters of intent, as discussed in Unit 
III.E. Therefore, EPA anticipates that the ECA process will focus 
generally on testing issues beyond or supplemental to those contained 
in the industry letters of intent.

A. Solicitation of Interested Parties

    EPA is soliciting interested parties to monitor or participate in 
negotiations on ECAs for PFOA and telomers. As discussed in Unit 
III.E., 3M; AGA Chemicals; Asahi Glass Fluoropolymers USA, Inc.; 
Clariant GmbH; Daikin America, Inc.; Dyneon LLC; and E.I. duPont de 
Nemours & Company, have been pursuing voluntary collective actions to 
address issues associated with PFOA and telomers and have been keeping 
EPA informed of these activities. Any person who desires treatment as 
an ``interested party'' during the development of the ECAs must respond 
in writing to this notice on or before May 16, 2003 following the 
instructions in Unit I., and must specifically request that they be 
given ``interested party'' status. These interested parties will not 
incur any obligations by being so designated. Negotiations will be 
conducted in one or more meetings, all of which will be open to the 
public. EPA will contact all interested parties who have expressed a 
desire to participate in or monitor the ECA negotiations and advise 
them of all meeting dates. EPA will also notify the public of such 
meeting dates in the electronic public docket for this action. The 
negotiation time schedule for PFOA and telomers will be established at 
the first negotiation meeting. It is EPA's current intent to move 
quickly to attempt to finalize any ECAs, if possible. If an ECA is not 
established in principle within a reasonable time-frame, negotiations 
will be terminated, and any unmet data needs may be pursued via a test 
rule promulgated under TSCA section 4. If the data generated from the 
ECA do not meet the Agency's needs, EPA reserves the right to proceed 
with rulemaking to obtain the needed data. EPA also reserves the right 
to announce and convene subsequent ECA negotiations for additional 
data, if the testing from voluntary activities, the initial ECA, or 
from a test rule identify additional data gaps which must be filled.

B. ECA Process and Public Participation in Negotiations

    EPA will provide the public with an opportunity to comment on and 
participate in the development of any ECAs on PFOA and telomers to 
ensure that the views of interested parties are taken into account 
during the ECA process. This process is described generally in this 
unit, and is more fully addressed in 40 CFR part 790.
    Individuals and groups who respond to this notice by May 16, 2003 
and request treatment as interested parties will have the status of 
interested parties. All negotiating meetings for the development of 
this ECA will be open to the public and minutes of each meeting will be 
prepared by EPA and placed in the official public docket for this 
action. The Agency will advise interested parties and the public of 
meeting dates and make available meeting minutes, testing proposals, 
background documents, and other relevant materials exchanged at or 
prepared for negotiating meetings. Where tentative agreement is reached 
on an acceptable testing program, a draft ECA will be made available 
for comment by interested parties and, if necessary, EPA will hold a 
public meeting to discuss any comments that have been received and 
determine whether revisions to the ECA are appropriate. EPA will not 
reimburse costs incurred by non-EPA participants in this ECA 
negotiation process.
    Enforceable consent agreements will only be concluded where an 
agreement can be obtained, which is satisfactory to the Agency, 
manufacturers or processors who are potential test sponsors, and other 
interested parties, concerning the need for and scope of testing. In 
the

[[Page 18633]]

absence of an ECA, EPA reserves the right to proceed with rulemaking.
    More specifically, EPA will not enter into an ECA if either the 
Agency and affected manufacturers or processors cannot reach an 
agreement on the provisions of the ECA, or the draft ECA is considered 
inadequate by other interested parties who have submitted timely 
objections to the draft ECA. However, EPA may reject these objections 
if the Agency concludes that:
    1. They are not made in good faith;
    2. They are untimely;
    3. They are not related to the adequacy of the proposed testing 
program or other features of the ECA that may affect EPA's ability to 
fulfill the goals and purposes of TSCA; or
    4. They are not accompanied by a specific explanation of the 
grounds on which the draft ECA is considered objectionable.
    EPA will prepare an explanation of the basis for each ECA. That 
document will summarize the agreement (including the needed data 
development), explain the objectives of the data collection/development 
activity, and outline the chemicals' use and exposure characteristics. 
That document, which will also announce the availability of the final 
ECA, will be published in the Federal Register. Upon the successful 
completion of an ECA, export notification under TSCA section 12(b) 
would be required for all signatories to the ECA who export or intend 
to export the chemicals subject to the ECA. A separate action would be 
published in the Federal Register following the announcement of the ECA 
to apply the export notification requirement to others by adding the 
ECA chemicals to the list of chemicals subject to testing consent 
orders at 40 CFR 799.5000.

VI. References

    These references have been placed in the official docket that was 
established under docket ID number OPPT-2003-0012 for this action as 
indicated in Unit I.B.2. Reference documents identified with an 
Administrative Record number (AR226-XXXX) are available in the public 
version of the official docket maintained in the OPPT Docket. Copies of 
these documents may be obtained as described in Unit I.B.2.
    1. USEPA. Preliminary Risk Assessment of the Developmental Toxicity 
Associated with Exposure to Perfluorooctanoic Acid (PFOA) and its 
Salts. OPPT, Risk Assessment Division. Washington, DC. April 10, 2003.
    2. Federal Register. (65 FR 62319, October 18, 2000) (FRL-6745-5); 
(67 FR 11008; March 11, 2002) (FRL-6823-6); (67 FR 11014, March 11, 
2002) (FRL-6823-7); (67 FR 72854, December 9, 2002) (FRL-7279-1).
    3. (AR226-0639) PFOS Presentation to CMA. Auer, Charles M., USEPA. 
Washington, DC. June 19, 2000.
    4. (AR226-1127) Revision of PFOA Hazard Assessment and Next Steps. 
Memorandum from Charles M. Auer to Oscar Hernandez, Mary Ellen Weber, 
and Ward Penberthy. USEPA. Washington, DC. September 27, 2002.
    5. Section 4(f) of TSCA (15 U.S.C. 2603 (4)).
    6. (AR226-0620) Sulfonated Perfluorochemicals in the Environment: 
Sources, Dispersion, Fate, and Effects. 3M. St. Paul, MN. March 1, 
2000.
    7. Environmental, Health And Safety Measures Relating to 
Perfluorooctanoic Acid and Its Salts (PFOA). Letter from Dr. Larry 
Wendling, 3M, to Stephen L. Johnson, USEPA. 3M. St. Paul, MN. March 13, 
2003.
    8. Characterization of Fluorinated Metabolites by a Gas 
Chromatographic-Helium Microwave Plasma Detector; The Biotransformation 
of 1H, 1H, 2H, 2H-Perfluorodecanol to Perfluorooctanoate. Hagen, Donald 
F.; Belisle, John; Johnson, James D.; and Venkateswarlu, P. Analytical 
Biochemistry. 118, 336-343 (1981).
    9. (AR226-1149). Revision 1, Biodegradation Screen Study for 
Telomer-Type Alcohols. Lange, Cleston C. Pace Analytical Services, 
Minneapolis, MN. November 6, 2002.
    10. Mabury, Scott. Annual Report of Activities for Telomer Research 
Program Grant to University of Toronto. University of Toronto, Toronto, 
Canada. September 2002.
    11. (AR226-1136) Revised Draft Hazard Assessment of 
Perfluorooctanoic Acid and Its Salts. USEPA, OPPT, Risk Assessment 
Division. Washington, DC. November 4, 2002.
    12. Voluntary Actions to Evaluate and Control Emissions of Ammonium 
Perfluorooctanoate (APFO). Letter from Charles D. Allen, Asahi Glass 
Fluoropolymers USA, Inc.; Takahiko Sakanoue, Daikin America, Inc.; 
James E. Gregory, Dyneon LLC.; and Richard J. Angiullo, E.I. duPont de 
Nemours & Company, to Stephen L. Johnson, USEPA. March 14, 2003.
    13. Letter of Intent for the Telomer Research Program from H. 
Okuno, AGA Chemicals, Inc.; Hans Ludwig Panke and Reinhard Jung, 
Clariant GmbH; Takahiko Sakanoue, Daikin America, Inc.; and Stephen H. 
Korzeniowski, E.I. duPont de Nemours & Company, to Stephen L. Johnson, 
USEPA. March 14, 2003.
    14. Order on Consent between E.I. duPont de Nemours & Company and 
USEPA, Region III and Region V. Philadelphia, PA. March 12, 2002.
    15. West Virginia Department of Environmental Protection. Final 
Ammonium Perfluorooctanoate (C8) Assessment of Toxicity Team (CATT) 
Report. Charleston, WV. August 2002.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances.


    Dated: April 14, 2003.
Stephen L. Johnson,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 03-9418 Filed 4-14-03; 1:26 pm]
BILLING CODE 6560-50-S