[Federal Register: September 5, 2007 (Volume 72, Number 171)]
[Notices]
[Page 50954-50960]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se07-42]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2007-0490; FRL-8146-2]
TSCA Section 21 Petition on Nonylphenol and Nonylphenol
Ethoxylates; Response to Citizens' Petition
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: On June 6, 2007, the Sierra Club, the Environmental Law and
Policy Center, the Pacific Coast Federation of Fishermen's
Associations, the Washington Toxics Coalition, Physicians for Social
Responsibility, and UNITE HERE petitioned EPA under section 21 of the
Toxic Substances Control Act (TSCA) to initiate rulemaking proceedings
under sections 4 and 6 of TSCA. Specifically, petitioners requested
that EPA require manufacturers and importers to conduct certain health
and safety studies under TSCA section 4; and also require, under TSCA
section 6(a), labeling on all products containing nonylphenol (NP) and
nonylphenol ethoxylates (NPEs), and limit the use of NP and NPEs where
the use of these substances presents an unreasonable risk to public
health and the environment. For the reasons set forth in this notice,
EPA is granting the petitioners' request to initiate a proceeding for
chronic aquatic toxicity testing under TSCA section 4 and will
[[Page 50955]]
also request comment on potential additional testing related to certain
of the petitioners' requests, but is denying the petition in regard to
TSCA section 6 and to the remaining specific TSCA section 4 requests.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address:
TSCA-Hotline@epa.gov.
For technical information contact: Mary Dominiak or John Schaeffer,
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 or (202)
564-8173; e-mail address:
dominiak.mary@epa.gov or schaeffer.john@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture,
import, or distribute in commerce NP or NPEs. Potentially affected
entities may include, but are not limited to:
Chemical manufacturers (including importers) (NAICS codes
325, 32411, e.g., chemical manufacturing and petroleum refineries) of
one or more of the subject chemicals.
Surface active agent manufacturers (NAICS code 325613).
Industrial launderers (NAICS code 81233).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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 a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2007-0490. All documents
in the docket are listed in the docket's index available at http://www.regulations.gov.
Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, will be publicly
available only in hard copy. Publicly available docket materials are
available electronically at http://www.regulations.gov, or, if only
available in hard copy, at the OPPT Docket. The OPPT Docket is located
in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays. The telephone number of the EPA/DC Public
Reading Room is (202) 566-1744, and the telephone number for the OPPT
Docket is (202) 566-0280. Docket visitors are required to show
photographic identification, pass through a metal detector, and sign
the EPA visitor log. All visitor bags are processed through an X-ray
machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.
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.
II. Background
A. What is a TSCA Section 21 Petition?
Section 21 of TSCA allows citizens to petition EPA to initiate a
rulemaking proceeding for the issuance, amendment, or repeal of a rule
under TSCA section 4, 6, or 8 or an order under TSCA section 5(e) or
6(b)(2). A TSCA section 21 petition must set forth facts that the
petitioner believes establish the need for the action requested. EPA is
required to grant or deny the petition within 90 days of its filing. If
EPA grants the petition, the Agency must promptly commence an
appropriate proceeding. If EPA denies the petition, the Agency must
publish its reasons for the denial in the Federal Register. The
petitioners may commence a civil action in a U.S. district court to
compel initiation of the requested rulemaking proceeding within 60 days
of either a denial or the expiration of the 90-day period.
B. What Criteria Apply to a Decision on a TSCA Section 21 Petition?
1. TSCA section 21. TSCA section 21, itself, does not expressly
identify the basis under which EPA should decide whether to grant or
deny a citizens' petition. Rather, TSCA section 21(b)(1) requires that
the petition set forth the facts that it is claimed establish it is
``necessary'' to issue a rule or order that is the subject of the
petition. In addition, TSCA section 21 establishes standards the court
must use to decide whether to order EPA to initiate rulemaking in the
event of a lawsuit filed by the petitioner after denial of a TSCA
section 21 petition. (15 U.S.C. 2620(b)(4)(B)). Further, TSCA section
21 implicitly incorporates the statutory standards under TSCA sections
4 and 6 for issuing regulations, requiring petitioners to ``set forth
the facts which it is claimed establish that it is necessary to
issue...a rule under section [4 or 6].'' (15 U.S.C. 2620(b)(1)
(emphasis added)). Accordingly, EPA has relied on the standards in TSCA
section 21 and in TSCA sections 4 and 6 as the basis for evaluating and
deciding on the NP/NPE petition.
2. Legal standards regarding TSCA section 4 test rules. Under TSCA
section 4, EPA must make a number of findings in order to issue a rule
to require testing. In all cases, EPA must find that data on a chemical
are insufficient to evaluate its effects and that testing of the
chemical is necessary to develop the missing data. (15 U.S.C.
2603(a)(1)(A) and (B)). In addition, EPA must either find that:
i. The chemical may present an unreasonable risk of injury or
ii. The chemical is:
a. Produced in substantial quantities, and
b. May either:
A. Result in significant or substantial human exposure, or
B. Result in substantial environmental release.
TSCA section 21 allows a court to order EPA to initiate rulemaking
if the court makes essentially the same determination after a de novo
review of the petition. However, TSCA section 21 omits the third
finding required under TSCA section 4 from the findings that a court
must make in order to require EPA to initiate TSCA section 4
rulemaking--i.e., the finding that ``testing is necessary to develop
the data.'' (15 U.S.C. 2620(b)(4)(B)(i)). Nonetheless, EPA believes
TSCA section 21(b)(4) is best interpreted as incorporating all of the
TSCA section 4 findings. The alternative would be to read the statute
as empowering a court
[[Page 50956]]
to require EPA to initiate a rule even where the Agency could not make
proposed findings consistent with TSCA section 4 or take final action
on the rule. EPA's interpretation is supported by legislative history.
(House conference report (H. Conf. Rept.) 94-1679 at 97-99 (1976)).
3. Legal standards regarding TSCA section 6 control rules. In
evaluating the request for rules under TSCA section 6 to control
chemicals, EPA assessed whether such rules are necessary to protect
against unreasonable risk. This is the same test the court would apply
under TSCA section 21.
The finding of unreasonable risk is a judgment under which the
decisionmaker determines that the risk of health or environmental
injury from a chemical outweighs the burden to society of potential
regulations. An unreasonable risk decision cannot be made considering
risk alone. Rather, the probability of harm must be considered against
the impacts of regulation. In promulgating any rule under TSCA section
6, the statute requires that the Administrator consider:
The effects of the substance or mixture on health and the
environment and the magnitude of the exposure of human beings and the
environment to the substance or mixture.
The benefits of the substance or mixture for various uses
and the availability of substitutes for such uses.
The reasonably ascertainable economic consequences of the
rule, after consideration of the effect on the national economy, small
business, technological innovation, the environment, and public health.
(15 U.S.C. 2605 (c)).
C. What Action is Requested Under this TSCA Section 21 Petition?
On June 6, 2007, the Sierra Club, the Environmental Law and Policy
Center, the Pacific Coast Federation of Fishermen's Associations, the
Washington Toxics Coalition, Physicians for Social Responsibility, and
UNITE HERE petitioned EPA to take action under TSCA section 4 for seven
categories of tests and under TSCA section 6 for four categories of
restrictions.
The requested actions under TSCA section 4 are:
1. Require testing to ``fill the gaps'' for chronic toxicity of NPE
oligomers (oligomers are the 1-2 mole ethoxylate of NP, also known as
``short-chain'' NPEs) to aquatic organisms.
2. Require the testing of mixtures to ``fill the gaps'' regarding
the additive toxicity of NP and NPE oligomers to aquatic organisms.
3. Require testing on the estrogenic disruption impact, including
multi-generational and population level impact, of NP and NPEs to
aquatic organisms.
4. Require testing of NP and NPEs for vitellogenin gene expression.
5. Require testing to ascertain certain aspects of NP and NPE
toxicity to humans, including general population exposure, metabolism,
dermal absorption, and placental development.
6. Require epidemiology testing for industrial laundry workers
exposed to NPEs.
7. Require testing to determine exposure to NPEs in residential
indoor air.
The requested actions under TSCA section 6 are:
1. Require labeling on all products containing NP and NPEs.
2. Restrict the use of NPEs where the user cannot verify that the
chemicals will receive proper wastewater treatment.
3. Ban the use of NP and NPEs in industrial and consumer
detergents.
4. Require pollution prevention planning by facilities that use
2,000 kilograms (kg) or more of NP or NPEs.
III. Disposition of Petition
Using the criteria in Unit II.B. to assess the NP/NPE petition, EPA
has concluded that, with respect to petitioners' first request for
chronic toxicity testing of ``short-chain'' NPEs, the petitioners have
provided facts demonstrating that existing data may be insufficient to
permit a reasoned evaluation of the effects of the chemicals, and that
the chemicals are produced in substantial quantities and either may
result in significant or substantial human exposure, or may result in
substantial environmental release. Accordingly, EPA grants the
petitioners' request that EPA initiate a proceeding for the issuance of
a rule under TSCA section 4 regarding chronic aquatic toxicity testing
on certain NPEs. However, EPA has determined that petitioners have not
provided facts to support the conclusion that the other tests they
requested are necessary to permit a reasoned evaluation of the
chemicals and EPA is, accordingly, denying the petitioners' remaining
specific TSCA section 4 testing requests. Further, EPA has determined
that petitioners failed to provide sufficient justification for any of
the requested control actions under TSCA section 6 and, therefore, EPA
is denying these requests. Each of the petitioners' requests is
addressed specifically in the following discussion.
A. Grant of Request to Initiate a Section 4 Test Rule
Petitioners' first request was that EPA initiate testing to
determine the chronic toxicity of NPEs, especially ``short-chain''
NPEs, ``for development of protective water quality criteria and
standards that account for the full range of negative impacts from NP
and NPEs.'' EPA agrees that data concerning the chronic effects of
``short-chain'' NPEs appear to be limited (Refs. 1 and 2) and may be
insufficient to adequately evaluate the risk of chronic exposures to
aquatic organisms from ``short-chain'' NPEs. However, to develop a
properly tailored test requirement that would provide EPA with
sufficient data, EPA believes it would be most productive to examine a
number of additional considerations prior to the issuance of a proposed
rule. These considerations include determining which NPEs might be
studied to adequately characterize the potential risk presented by
chronic exposures to these chemicals, based on such factors as the
potential for aquatic organisms to be exposed to them. For example,
NP1EO and NP2EO have been detected in the environment and may be the
candidates for further testing, but other NPEs, including various
derivatives and degradation products, may not need to be considered.
EPA further notes that, if adequate acute aquatic toxicity testing data
are not already available on specific NPEs in the same species
appropriate for chronic testing, those acute data may need to be
developed in order to set appropriate concentration levels for chronic
testing and for calculating acute-to-chronic ratios. Additional
considerations may include determining how many taxa are needed, and
which species in those taxa would be most appropriate in order to
properly characterize the potential aquatic toxicity of the chemicals
present in freshwater and saltwater systems. EPA may also consider
whether chronic aquatic toxicity testing for NP in saltwater fish
species may be warranted, and whether testing to assess the toxicity
and fate of sediment-bound NP in both freshwater and marine/estuarine
habitats should be considered, since these data are limited (Refs. 2,
3, and 4). Finally, EPA notes that the apparent focus of the petition
is the development of water quality criteria (WQC). Although
petitioners have referenced testing designed to satisfy the
requirements imposed by States and EPA for data sufficient for setting
WQC values, EPA notes that the standards for setting WQC are different
than the standard for requiring testing under TSCA section 4, and a
reasoned
[[Page 50957]]
evaluation of the chemicals under TSCA may require different tests than
the full battery of studies necessary to issue such criteria.
Accordingly, rather than initially proposing a rule pursuant to TSCA
section 4, where the Agency would present its preliminary conclusions
on these points, EPA will publish an Advanced Notice of Proposed
Rulemaking (ANPRM) initiating proceedings under TSCA section 4. The
ANPRM will identify these issues for public comment. The information
received from this process would guide EPA in developing a proposed
testing program under TSCA section 4.
B. Denials of Requests to Initiate TSCA Section 4 Test Rules
Petitioners' second request was that EPA ``fill the data gaps
regarding the additive toxicity of NP and NPE oligomers to species.''
Petitioners requested testing of unspecified mixtures of NP and NPEs in
acute and chronic assays to address this perceived gap. The petitioners
noted that, given their similar structure and mode of action, the
toxicity of NP and NPEs may be additive. EPA currently believes that
the question of additive toxicity of various NPEs would not be
addressed effectively by requiring the testing of unspecified mixtures
of them. Additive toxicity is often more pragmatically addressed by
using methods to combine the results of testing the individual
components of mixtures. Petitioners provided no rationale to explain
why this more pragmatic approach of testing individual chemicals would
be inadequate in this instance. Therefore, EPA does not believe it has
the basis at this time to support the finding required under TSCA
section 4(a)(2) for ordering the testing of mixtures: That the effects
of the mixture ``may not be reasonably and more efficiently
determined...by testing the chemical substances which comprise the
mixture.'' EPA considers that obtaining certain acute and chronic
aquatic toxicity data on the appropriate individual NPE, as described
in this unit in the response to petitioners' first request, could
provide useful information addressing the additive toxicity question
raised by petitioners. EPA thus denies the specific request that EPA
order the testing of mixtures, but EPA may consider multiple approaches
to addressing the questions concerning possible additive toxicity in
the ANPRM.
Petitioners' third request was that EPA conduct research on
individual endocrine disruption impacts and on the relationship between
individual endocrine disruption impacts and population-level impacts,
including multi-generation effects. In general, EPA questions whether
such mechanism-specific testing is needed to permit a reasoned
evaluation of these chemicals given other data that exist and the
additional data that EPA would consider in the ANPRM. Available studies
already evaluate effects on the test organisms' mortality, growth, and
reproduction, which are apical to any endocrine disruption that may
occur. As summarized in EPA's Office of Water Ambient Water Quality
Criteria (WQC) Document for NP, the ability of nonylphenol to induce
estrogenic effects has seldom been reported at concentrations below the
freshwater final chronic value of 6.6 micrograms/Liter ([micro]g/L)
(Ref. 3). EPA considers at this time that the existing data,
particularly combined with the acute and chronic aquatic toxicity data
that EPA proposes to discuss in its ANPRM, would be sufficient to
evaluate effects on individuals and populations (Refs. 3, 5, and 6). In
addition, test methods to assess multi-generational impacts are not
currently available, and it is not yet certain that such methods would
provide data that would significantly advance understanding beyond
existing chronic study data with regard to NP, given that NP
demonstrates estrogenic effects at concentrations at or above which
chronic effects are also seen. The Office of Prevention, Pesticides,
and Toxic Substances (OPPTS) Endocrine Disruptor Screening Program
(EDSP) is currently developing and validating freshwater and saltwater
fish 2-generation test methods and also a crustacean (mysid) 2-
generation test method. However, those methods are not expected to be
fully validated before 2010, and additional work with the test method
will be required to demonstrate the benefit of performing these
studies. As noted in the WQC document, when the appropriate EDSP
testing protocols have been developed and validated, EPA may consider
whether additional testing of NP and NPE might be warranted (Ref. 3).
For these reasons, EPA cannot conclude that the available information
relevant to this requested testing is insufficient to permit a reasoned
evaluation of the health or environmental effects of these chemicals or
that the requested testing is necessary, and EPA, therefore, denies
this request.
Petitioners' fourth request was that EPA apply a specific
vitellogenin gene expression assay to NP and each individual NPE. In
general, EPA questions whether such mechanism-specific testing is
needed to permit a reasoned evaluation of these chemicals given other
data that exist. Several different vitellogenin gene expression tests
exist (Refs. 7, 8, and 9), but each serves the same purpose of
demonstrating the potential of a chemical for estrogenic expression.
The Agency considers that available information on NP and various NPEs
is sufficient to adequately demonstrate and evaluate the estrogenic
expression of NP and also to provide enough of a basis on which to
project the lesser contribution of various NPEs, making further
vitellogenin assays unnecessary (Refs. 5, 6, 10, and 11). Accordingly,
EPA cannot conclude that the available information relevant to this
requested testing is insufficient to permit a reasoned evaluation of
the health or environmental effects of these chemicals or that the
requested testing is necessary, and EPA, therefore, denies the request
for a TSCA section 4 test rule requiring the vitellogenin gene
expression assay.
Petitioners' fifth request encompasses a diverse cluster of
testing, including dermal absorption, oxidative metabolism, the effects
of NP on human placental development, and NP and NPE exposure to the
general population of the United States. Data to evaluate these effects
either already exist or are being generated under other programs and
need not be duplicated. For example, a combination of existing human
and animal studies provides a reasonable understanding of the
metabolism of NP in humans. The data available indicate a metabolic
profile common to phenols (Refs. 12, 13, and 14). In addition, studies
on dermal absorption of NP and NPEs have already been conducted and
have concluded that dermal absorption of NP is negligible, and that
dermal absorption of NPEs through human and animal skin is less than 1%
(Ref. 15). The petitioners cited a study done on human placental tissue
suggesting that NP may have some effect on trophoblastic cells of the
placenta, and specifically requested that a similar study be repeated.
EPA does not believe that repeating this non-standard study or
attempting to design a similar one would add to the understanding of
these chemicals, because existing studies on whole organisms have
already more fully addressed reproductive and other health effects
(Ref. 16). Reproductive studies of NP in mammals have been conducted
(Refs. 17 and 18), as well as other studies which have examined the
estrogenic effects of NP in mammals (e.g., uterotrophic assay) (Refs.
19, 20, and 21), and, on the basis of these data,
[[Page 50958]]
EPA believes it has sufficient information to evaluate NP's
reproductive risks to human health without conducting a non-standard
placental study of the type requested by petitioners. With regard to
assessing NP and NPE exposure to the general U.S. population, EPA notes
that the Centers for Disease Control and Prevention (CDC) indicated
through a notice published in 2003 that NP has already been slated for
inclusion in the National Report on Human Exposure to Environmental
Chemicals, and there is thus no need for EPA to duplicate that activity
(Ref. 22). For these reasons, EPA cannot conclude that the available
information relevant to this requested testing is insufficient to
permit a reasoned evaluation of the health or environmental effects of
these chemicals or that the requested testing is necessary, and EPA,
therefore, denies these requests for testing under TSCA section 4.
Petitioners' sixth request was that EPA conduct an epidemiology
study of industrial laundry workers who may be exposed to NP and NPEs
in detergents. Before an epidemiology study can be effectively designed
or conducted, however, there needs to be evidence that there are
sufficient exposures to a substance to warrant a study of human health
effects potentially attributable to those exposures. As noted in the
comments submitted by the Uniform and Textile Service Association
(UTSA) and the Textile Rental Services Association (TRSA),
approximately 90% of industrial laundries use injected liquid detergent
(Ref. 23). Given the low volatility (Ref. 24) and the negligible dermal
absorption of NP and NPE (Ref. 15), these industrial laundry operations
would not present significant exposure potential. Accordingly, there is
no evidence to support a conclusion that significant exposures exist
that would warrant an epidemiological study in this overall industry.
However, for the approximate 10% of industrial laundry operations and
an unknown number of institutional laundry operations that may use
powdered detergent, EPA considers that there is potential for
inhalation exposure to dust containing NP and NPE by workers and that
the number of potentially exposed workers involved could be substantial
(Ref. 25). As these concerns are based on estimates and not actual
exposure monitoring data, they would not support a conclusion that
there are sufficient exposures to warrant an epidemiology study.
However, EPA considers that obtaining additional exposure information
may be warranted to reasonably assess the potential for risk associated
with this one exposure scenario. Accordingly, EPA denies the
petitioners' specific request for an epidemiology study, but plans to
include in the ANPRM a discussion of the need for data concerning NP
and NPE exposures of laundry workers where powdered detergents are
used, and to solicit comment on the best means to obtain that
information (e.g., whether through requiring an exposure study,
workplace exposure monitoring, the voluntary submission of existing
monitoring data, or other means).
Finally, the petitioners' seventh request concerned ordering a
nationwide study of residential exposures based on one study which
found levels of NP and NPEs in dust and indoor air in all homes in the
study. However, in both the study cited by petitioners and in a second
study that found NP or NPEs in only 10% of the homes studied (Refs. 26
and 27), the levels of NP found were far below any level of concern
suggested in reviews (e.g., Ref. 16). Neither study could be assumed to
be representative of households across the United States, but both
studies would suggest that residential indoor air and dust do not
contribute significantly to household exposure. Therefore, EPA cannot
conclude that the available information relevant to this requested
testing is insufficient to permit a reasoned evaluation of the health
effects of these chemicals. Similarly, EPA believes there is no
evidence indicating that exposures of the general population to NP and
NPEs are of concern at the present, and notes that the CDC human
biomonitoring work will provide nationally representative data on the
levels of general population exposures to NP irrespective of exposure
source. Accordingly, EPA denies the request for a nationwide
residential exposure study under TSCA section 4.
C. Denial of Requests to Issue TSCA Section 6 Control Rules
EPA has concluded that the petitioners have not set forth the facts
establishing the need for the control actions requested under TSCA
section 6. Although the petition asserts that an unreasonable risk
exists, the petition does not present a reasonable basis to conclude
both that the chemicals present or will present an unreasonable risk
and that the specific actions requested by petitioners would be
necessary to protect adequately against such risk using the least
burdensome requirements. Accordingly, EPA denies the petitioners'
requests for control actions under TSCA section 6.
The petitioners requested that EPA issue TSCA section 6 actions to
require labeling, not just Material Safety Data Sheets (MSDSs), on all
products containing NP and NPE; to restrict the use of NP and NPE where
the user (including the 25% of U.S. households that rely on septic
systems) cannot verify that the chemical will receive proper/effective
treatment at a well-managed sewage treatment plant from an activated
sludge treatment process designed to nitrify; to ban the use of the
chemicals in industrial and consumer detergents in favor of existing,
less toxic alternatives; and, similar to Canada, to require facilities
that use 2,000 kg or more of NP or NPEs to develop formal pollution
prevention plans, and to consider safer substitutes consistent with
OPPT's Safer Detergents Stewardship Initiative (SDSI).
As noted in Unit III.B., in order to issue a rule under TSCA
section 6, EPA must affirmatively find that the risks are unreasonable,
and in making that determination, must consider a number of specified
issues. These relate not merely to the effects of the chemical(s), but
also to:
1. The benefits of the substance(s) for various uses and the
availability of substitutes for such uses.
2. The reasonably ascertainable economic consequences of the
control mechanisms proposed to control the risk, including the effect
on the national economy and small business and technical innovation.
These considerations are integral to the determination that a substance
presents an unreasonable risk, and the petitioners have not presented
sufficient facts to allow EPA to evaluate the issues. It is not
sufficient in a petition under TSCA section 21 to assert that an
unreasonable risk exists without providing the facts that would support
that assertion.
For example, in presenting their argument for actions under TSCA
section 6, the petitioners failed to provide information that would
permit consideration of the effect of their requested controls on the
national economy, small business and technological innovation, the
environment, and public health. Petitioners asserted that the costs of
their requested controls would be small and that the benefits of their
controls would reduce risk, but provided no data to substantiate either
their estimates of cost or of the efficacy of their proposed control
actions.
In addition, petitioners did not address the extent to which
actions taken under other statutes or voluntary programs may already be
addressing the
[[Page 50959]]
risk that may be presented by these chemicals, and whether those other
statutes or voluntary programs may provide more appropriate tools than
TSCA section 6 action to control risk to the extent necessary as
additional data are generated on chemical effects and exposure. EPA has
addressed NP and, to some extent, NPE in recent regulatory actions with
respect to water quality criteria (Refs. 3 and 28) and to the
reassessment of tolerances for pesticide inerts on food (Ref. 29). EPA
also sought public comment in May 2007 on SDSI (Ref. 30). SDSI is
intended to complement the water quality criteria for NP by promoting
the voluntary conversion by the detergent industry to alternative
surfactants that break down quickly to less toxic compounds. EPA must
assess those public comments and the potential of SDSI to impact the
need for any further regulatory controls.
The data and information supplied in the petition and the
information provided in public comments do not provide a reasonable
basis to conclude that NP or NPE pose an unreasonable risk to health or
the environment. Consequently, EPA has determined that petitioners have
failed to provide sufficient justification for any of their requests
for control actions under TSCA section 6 of TSCA, and EPA is denying
the request that EPA initiate actions under TSCA section 6.
IV. Comments Received
EPA published a notice in the Federal Register issue of July 10,
2007, announcing receipt of the petition and inviting public comment on
or before July 25, 2007 (Ref. 31). EPA received ten timely comments
from one individual, one petitioner, one State agency, and seven
nonprofit trade or professional associations, and about 1,900 mass-
mailed comments from private citizens through a mass comment campaign
evidently sponsored by one or more of the petitioners. EPA also
received a request for an extension of the comment period on July 25,
2007, submitted by UNITE HERE and the Sierra Club, two of the
petitioners. The request for extension was denied because of the
schedule for response mandated by TSCA section 21, although EPA
indicated that late comments would be considered to the extent
possible. One late comment was submitted on August 1, 2007, by another
trade association. One State agency submitted a late letter addressed
to the Administrator which was received on August 6, 2007, and was
directed to the docket as a late comment.
The petitioner (the Environmental Law and Policy Center), the
individual, the two State agencies (the New York State Department of
Environmental Conservation and the Illinois Environmental Protection
Agency), and the mass mailing campaign supported the petition, without
presenting additional significant substantive data apart from an
additional reference provided by the petitioner. This reference
concerned data already in EPA's possession.
All but one of the trade or professional organizations opposed the
petition on the grounds that existing data were already sufficient to
assess the chemicals and that no unreasonable risk was demonstrated in
the petition. Five of the organizations (the UTSA, the TRSA, the Soap
and Detergent Association, the Consumer Specialty Products Association,
and the Alkylphenols and Ethoxylates Research Council) submitted
detailed comments with references to data. These data were already in
EPA's possession. The remaining opposing organization (CropLife
America) and the association submitting late comments (the Chemical
Producers and Distributors Association) supported the position
expressed by the Alkylphenols and Ethoxylates Research Council.
The National Association of Clean Water Agencies (NAWCA) did not
comment on the substance of the petition, but indicated that any action
taken by EPA in response to the petition should not place the burden
for response on the nation's wastewater treatment utilities.
V. References
1. Staples, C.; Mihaich, E.; Carbone, J.; Woodburn, K.; and Klecka,
G. 2004. A Weight of Evidence Analysis of the Chronic Ecotoxicity of
Nonylphenol Ethoxylates, Nonylphenol Ether Carboxylates, and
Nonylphenol. Human and Ecological Risk Assessment. 10(6): 999-1017.
2. Environment Canada. Canadian Environmental Quality Guidelines
for Nonylphenol and its Ethoxylates (Water, Sediment, and Soil).
Scientific Supporting Document. Ecosystem Health: Science-based
Solutions Report No. 1-3. National Guidelines and Standards Office,
Environment Canada, Ottawa. 189 pp. August 2002.
3. EPA. 2005. Aquatic Life Ambient Water Quality Criteria -
Nonylphenol Final. EPA, Office of Water. Washington, DC. EPA-822-R-05-
005. 96 pp.
4. State of New York Department of Environmental Conservation.
Letter from Alexander Grannis, Commissioner, New York State Department
of Environmental Conservation, to Document Control Office, Office of
Pollution Prevention and Toxics (OPPT), EPA. Docket ID number EPA-HQ-
OPPT-2007-0490-0009. July 25, 2007.
5. Mills, L.J. and Chichester, C. 2005. Review of evidence: Are
endocrine-disrupting chemicals in the aquatic environment impacting
fish populations? Science of the Total Environment. 343: 1-34.
6. United States Department of Agriculture (USDA). Human and
Ecological Risk Assessment of Nonylphenol Polyethoxylate-based (NPE)
Surfactants in Forest Service Herbicide Applications. Prepared by David
Bakke, USDA, Forest Service, Region 5. May 2003. 110 pp.
7. Thorpe, K.L.; Hutchinson, T. H.; Hetheridge, M .J.; Sumpter,
J.P.; and Tyler, C.R. (2000). Development of an in vivo screening assay
for estrogenic chemicals using juvenile rainbow trout (Oncorhynchus
mykiss). Environmental Toxicology and Chemistry. 19:2812-2820.
8. Lattier, D.L.; Gordon, D.A.; Burks, D.J.; and Toth, G.P. 2001.
Vitellogenin gene transcription: A relative quantitative exposure
indicator of environmental estrogens. Environmental Toxicology and
Chemistry. 20:1979-1985.
9. Biales, A.D.; Bencic, D.C.; Flick, R.W.; Lazorchak, J.; and
Lattier, D.L. 2007. Quantification and associated variability of
induced vitellogenin gene transcripts in fathead minnow (Pimephales
promelas) by quantitative real-time polymerase chain reaction.
Environmental Toxicology and Chemistry. 26:287-296.
10. Seki, M.; Yokota, H.; Maeda, M.; Tadokoro, H.; and Kobayashi,
K. 2003. Effects of 4-nonylphenol and 4-tert-octylphenol on sex
differentiation and vitellogenin induction in medaka (Oryzias latipes).
Environmental Toxicology and Chemistry. 22(7):1507-1516.
11. Dussault, E.B.; Sherry, J.P.; Lee, H.B.; Burnison, B.K.;
Bennie, D.T.; and Servos, M.R. 2005. In vivo estrogenicity of
nonylphenol and its ethoxylates in the Canadian environment. Human and
Ecological Risk Assessment. 11(2): 353-364.
12. Muller, S.; Schmid, P.; and Schaltter, Ch. 1998.
Pharmacokinetic behavior of 4-nonylphenol in humans. Environmental
Toxicology and Pharmacology. 5, 257-265
13. Knaak, J.B.; Eldridge, J.M.; and Sullivan, L.J. 1966. Excretion
of certain polyethylene glycol ether adducts of nonylphenol by the rat.
Toxicology and Applied Pharmacology. 9, 331-340.
[[Page 50960]]
14. Fennel, T.R. and MacNeela, J.P. 1997. Disposition and
metabolism of nonylphenol in male and female. SOT conference poster
abstract.
15. Monteiro-Riviere, N.A.; Van Miller, J.P.; Simon, G.; Joiner,
R.L.; Brooks, J.D.; and Riviere, J.E. 2000. Comparative in vitro dermal
absorption of nonylphenol and nonylphenol ethoxylates (NPE-4 and NPE-9)
through human, porcine, and rat skin. Toxicology and Industrial Health.
16:49-57.
16. European Commission - Joint Research Centre. Institute for
Health and Consumer Protection. European Chemicals Bureau. 2002.
European Union Risk Assessment Report. 4-nonyl-phenol (branched) and
nonylphenol. CAS No: 84852-15-3, 25154-52-3. EINECS No: 284-325-5, 246-
672-0. Series: 2\nd\ Priority List, Volume 10. Final Report.
17. Chapin, R.E.; Delaney, J.; Wang, Y.; Lanning, L.; Davis, B.;
Collins B; Mintz, N.; and Wolfe, G. 1999. The effects of 4-nonylphenol
in rats: A multi-generation reproduction study. Toxicological Sciences.
52: 80-91.
18. de Jaeger, C.; Bornman, M.S.; and van der Horst, G. 1999. The
effect of p-nonylphenol, an environmental toxicant with oestrogenic
properties, on fertility potential in adult male rats. Andrologia. 31,
99-106.
19. Odum, J.; Lefevre, P.A; Tittensor, S.; Paton, D.; Routledge,
E.J.; Beresford, N.A.; Sumpter, J.P.; and Ashby, J. 1997. The rodent
uterotrophic assay: Critical protocol features, studies with
nonylphenols, and comparison with a yeast estrogenicity assay.
Regulatory Toxicology and Pharmacology. 25, 176-188.
20. Lee, P.C. and Lee, W. 1996. In vivo estrogenic action of
nonylphenol in immature female rats. Bulletin of Environmental
Contamination and Toxicology. 57(3): 341-348.
21. Kim, H.S.; Shin, J-H; Moon, H.J.; Kang, I.H.; Kim, T.S.; Kim,
I.Y.; Seok, J-H; Pyo, M-Y; and Han, S.Y. 2002. Comparative estrogenic
effects of p-nonylphenol by 3-day uterotrophic assay and female
pubertal onset assay. Reproductive Toxicology. 16(3): 259-268.
22. CDC, HHS. Candidate Chemicals for Possible Inclusion in Future
Releases of the National Report on Human Exposure to Environmental
Chemicals. Federal Register (68 FR 56296, September 30, 2003) (FR Doc.
03-24671; Filed 9-29-03). Available on-line at http://www.cdc.gov/exposurereport/pdf/fr_093003.pdf
.
23. UTSA and TRSA. Letter from Tony Wagner, Director, Environmental
and Government Affairs, Uniform and Textile Service Association and
Robert Schaffer, Director, Environmental Affairs, Textile Rental
Services Association to Office of Pollution Prevention and Toxics
(OPPT), Document Control Office. Re: Comments of the Uniform and
Textile Service Association (UTSA) and Textile Rental Services
Association of America (TRSA) on TSCA Section 21 Petition on
Nonylphenol and Nonylphenol Ethoxylates: Docket ID number EPA-HQ-OPPT-
2007-0490-0010. July 25, 2007.
24. EPA. E-mail communication from Greg Fritz to John Schaeffer and
Mary Dominiak. Subject: Vapor Pressure estimates for NP and NPEs (NP1EO
and NP2EO) (with two attachments: Huntsman Corporation Technical
Bulletin: SURFONIC[reg] N-31.5 Surfactant (2005) and EPIWIN [SRC CORP.]
Program Estimates (EPI--est.doc)). August 14, 2007.
25. EPA. Draft Engineering Report of Nonylphenol (NP) and
Nonylphenol Ethoxylates (NPEs) In Response to Section 21 Petition. EPA,
OPPT, Economics, Exposure and Technology Division, Chemical Engineering
Branch. July 18, 2007. 15 pp.
26. Rudel, R.A.; Camann, D.E.; Spengler, J.D.; Korn, L.R.; and
Brody, J.G. 2003. Phthalates, Alkylphenols, Pesticides, Polybrominated
Diphenyl Ethers, and Other Endocrine-Disrupting Compounds in Indoor Air
and Dust. Environmental Science and Technology. 37 (20):4543-4553.
27. Morgan, M.K.; Sheldon, L.S.; and Croghan, C.W. 2004. A Pilot
Study of Children's Total Exposure to Persistent Pesticides and Other
Persistent Organic Pollutants (CTEPP). Volume I: Final Report to U.S.
Environmental Protection Agency, Contract Number 68-D-99-011, Task
Order 0002.
28. EPA. Notice of Availability of Final Aquatic Life Ambient Water
Quality Criteria for Nonylphenol. Notice. Federal Register (71 FR 9337,
February 23, 2006) (FRL-OW-8035-8). Available on-line at http://www.epa.gov/fedrgstr
.
29. EPA. Memorandum from Kerry Leifer, Inert Ingredient Assessment
Branch, Registration Division and Pauline Wagner, Chief, Inert
Ingredient Assessment Branch, Registration Division to Lois Rossi,
Director, Registration Division. Subject: Reassessment of Four
Exemptions from the Requirement of a Tolerance for Nonylphenol
Ethoxylates (with attached Action Memorandum: Inert Reassessments: Four
Exemptions from the Requirement of a Tolerance for Nonylphenol
Ethoxylates, dated July 31, 2006).
30. EPA. Safer Detergents Stewardship Initiative (SDSI). Available
on-line at http://www.epa.gov/dfe/pubs/projects/formulat/sdsi.htm.
Agency Information Collection Activities; Proposed Collection; Comment
Request; Safer Detergent Stewardship Initiative (SDSI) Program; EPA ICR
No 2261.01, OMB Control No. 2070-new. Notice. Federal Register (72 FR
26357, May 9, 2007) (FRL-8125-4). Available on-line at http://www.epa.gov/fedrgstr
.
31. EPA. TSCA Section 21 Petition on Nonylphenol and Nonylphenol
Ethoxylates; Notice of Receipt. Notice. Federal Register (72 FR 37530,
July 10, 2007) (FRL-8139-7). Available on-line at http://www.epa.gov/fedrgstr
.
List of Subjects
Environmental protection, Hazardous substances, Nonylphenol,
Nonylphenol Ethoxylates.
Dated: August 29, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E7-17542 Filed 9-4-07; 8:45 am]
BILLING CODE 6560-50-S