[Federal Register: April 16, 2003 (Volume 68, Number 73)]
[Notices]
[Page 18626-18633]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ap03-64]
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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: TSCA-
Hotline@epa.gov. 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: dominiak.mary@epa.gov.
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
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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 oppt.ncic@epa.gov,
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
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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
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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