[Federal Register Volume 74, Number 115 (Wednesday, June 17, 2009)]
[Proposed Rules]
[Pages 28654-28662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14250]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[EPA-HQ-OPPT-2007-0490; FRL-8416-8]
RIN 2070-AJ34
Testing of Certain Nonylphenol and Nonylphenol Ethoxylate
Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: On June 6, 2007, the Environmental Law and Policy Center, the
Sierra Club, the Pacific Coast Federation of Fishermen's Associations,
the Washington Toxics Coalition, Physicians for Social Responsibility,
and UNITE HERE (hereinafter ``petitioners''), petitioned EPA under
section 21 of the Toxic Substances Control Act (TSCA) to initiate
rulemaking proceedings under section 4 and section 6 of TSCA for the
substances nonylphenol (NP) and nonylphenol ethoxylates (NPEs). EPA
granted the petitioners' request for chronic aquatic toxicity testing
and a few other aspects of the petitioners' TSCA section 4 request, but
denied all of the petitioners' section 6 requests. Subsequently, on
October 24, 2007, the petitioners filed suit in the U.S. District Court
for the Northern District of California challenging EPA's denial of
their TSCA section 21 petition. The lawsuit was mediated and, in an
agreement signed on December 30, 2008, the parties settled the case.
EPA is now providing this advance notice of proposed rulemaking (ANPRM)
for aquatic and sediment toxicity testing under TSCA section 4 for
these substances, and is also requesting comment on gathering data
under TSCA and through other means to facilitate the evaluation of
industrial laundry worker exposure to NPEs.
DATES: Comments must be received on or before September 15, 2009.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2007-0490, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of
Pollution Prevention and Toxics (OPPT), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2007-0490. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-0490. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the docket index
available in regulations.gov. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, 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
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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.
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: [email protected].
For technical information contact: 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) 564-8173; e-mail
address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be interested in this action if you manufacture (defined by
statute to include import) or process 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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II.B. and Unit
II.D.1. If you have any questions regarding the applicability of this
action to a particular entity, consult the technical person listed
under FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What is the Purpose and Background of this ANPRM?
EPA is publishing this ANPRM as a follow-up to its response to
certain TSCA section 4 test rule development requests made to EPA by
the petitioners under TSCA section 21. Under TSCA section 21, any
person may petition EPA to initiate a rulemaking proceeding for the
issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8
or an order under TSCA sections 5(e) or 6(b)(2). In the petition filed
under TSCA section 21 in June 2007, the petitioners' requested that EPA
require manufacturers and importers to conduct certain health and
safety studies under TSCA section 4, and also requested certain TSCA
section 6(a) actions for NP and NPEs (Ref. 1).
In its response to the TSCA section 21 petition (Ref. 2), EPA
agreed that there may be a need for aquatic chronic toxicity testing
for the short-chain NPEs. However, as EPA noted in its response, the
particulars of a proposed testing program to evaluate aquatic toxicity
of NPEs are uncertain, including which, and how many test chemicals and
test species to include. In regard to an additional TSCA section 4
request, EPA denied that epidemiological testing is necessary, but did
conclude that there may be a need for data to determine exposure to
industrial laundry workers. However, EPA believes that additional
information is needed to resolve:
1. Whether an exposure study (or studies) of industrial laundry
workers' exposure to NPEs is warranted, and if so,
2. What kind of exposure study(ies) should be performed.
The TSCA section 21 petition and EPA's response, described in a Federal
Register document that published on September 5, 2007, are available in
the docket for this action (Refs. 1 and 2).
On October 24, 2007, the petitioners filed suit in the U.S.
District Court for the Northern District of California (Ref. 56)
challenging EPA's denial of the requests in the TSCA section 21
petition. This lawsuit was mediated and, in an agreement signed on
December 30, 2008, the parties settled the case (Ref. 57). As part of
the settlement, the parties agreed to ask the Court to dismiss the case
with prejudice within 10 days of the publication of this ANPRM. Copies
of the original filing and the final settlement agreement are available
in the docket for this action (Refs. 56 and 57).
The purpose of this ANPRM is to solicit public input and obtain
additional information relevant to whether and what kind of testing to
propose concerning aquatic toxicity testing of NP and NPEs, and also to
solicit comment relevant to establishing the necessity for, and the
type of studies useful to, determining exposure of industrial laundry
workers to NPEs. EPA is also soliciting comment on the cost of the
proposed testing and the
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capacity of laboratories to conduct the testing.
B. What are the Chemical Substances of Concern to EPA in this ANPRM?
The chemicals of concern in this ANPRM are NPEs, especially the
short-chain NPEs, and NP. NP has little direct use itself, but is used
as an intermediate to produce other chemicals, especially long-chain
NPEs (Ref. 3). NPEs are manufactured by combining NP with ethylene
oxide in an iterative process forming a mixture of NPEs of various
chain lengths of 4 to 80 ethoxylate (EO) groups (e.g., NP4EO to NP80EO)
(Refs. 3 and 4). Commercially, the commonly used NPEs have chain
lengths of 8 to 12 EO groups (Ref. 5). Commercial mixtures of NPEs may
contain a mixture of NPEs of various chain lengths; and NPEs may occur
in either straight, or, more typically, branched forms. Different chain
lengths have different properties and determine the particular
industrial application and uses of the NPE substances. Common uses of
NPEs include such consumer products as laundry detergents, shampoos,
household cleaners and latex paints. Industrial uses include their use
as surfactants, detergents, wetting agents and defoamers, among other
uses (Refs. 3, 4, 6, and 7).
C. What Testing is EPA Considering in this ANPRM?
As described in this ANPRM, the testing EPA is considering is
focused on aquatic toxicity testing for the short-chain NPEs, i.e., NP
with one or two EO groups attached (NP1EO and NP2EO) and NP. As
discussed in more detail in this unit, NP1EO, NP2EO, and NP occur in
the environment mainly as degradation products of the longer-chain
NPEs. In its response to the petitioners, EPA agreed that data
concerning the toxic effects of the short-chain NPEs appear to be
limited for aquatic organisms. In addition, for NP and short-chain
NPEs, EPA concluded that there may be insufficient data to evaluate the
effects of these substances on sediment-dwelling organisms. Data that
are available indicate that these substances are highly toxic to fish
and invertebrates, causing lethality on an acute basis and effects on
growth, reproduction, and survival with low-level chronic exposures
(Refs. 31 and 32). While data exist that are indicative of these
effects, for the short-chain NPEs, and also for sediment-dwelling
organisms, data may be insufficient for EPA to adequately evaluate the
risk to aquatic and sediment-dwelling organisms from exposures to NP
and short-chain NPEs. EPA also recognizes that at least part of the
toxic mode of action for these substances may include disruption of the
organism's endocrine system. For purposes of risk assessment, the
testing EPA is considering in this ANPRM may adequately account for
these effects. However, as additional data and test methods become
available, EPA may propose testing protocols to better address
endocrine disruption effects specifically.
NPEs and NP as a class of compounds are considered to be
inherently, though not readily, biodegradable and, compared to some
other surfactants, are relatively resistant to biodegradation (Refs. 4
and 6). In the environment and in wastewater treatment facilities
(WWTFs), the long-chain NPEs degrade relatively quickly when compared
to short-chain NPEs and NP (Refs. 8-12). Short-chain NPEs are more
resistant to further degradation to NP (Ref. 13). With sufficient time
NP is ultimately degraded to CO2 and water (mineralization),
but this process is much longer that the degradation of NPEs to NP
(Refs. 3 and 13-15). As a result, although most NPEs are used and
released as long-chain NPEs, concentrations of short-chain NPEs and NP
are relatively high compared to the long-chain NPEs in WWTF effluent
and in environmental samples (Refs. 3, 4, and 16-24).
The following studies are illustrative of sampling results for these
compounds in U.S. waterways:
A study by Rice et al. (2003) examined a 74 mile stretch
of the Cuyahoga River, Ohio. They found that urbanized areas typically
contain higher levels of NP and NPEs, with maximum concentrations found
in water samples near WWTF discharge sites. At the sampling site
closest to the Akron WWTF discharge location, 2.1 miles downstream,
they found NP, NP1EO, NP2EO, and NP3EO at concentrations of 0.47, 0.60,
1.50, and 2.40 microgram/Liter ([mu]g/L), respectively. However, the
combined NP to NPE3EO concentrations in water samples at 7 additional
sites along the river were much lower, with total concentrations
ranging from only 0.13 to 1.0 [mu]g/L (Ref. 22).
Similarly, Barber et al. (2000) found detectable levels of
combined NP, NP1EO, and NP2EO of 3.36 [mu]g/L (fall samples) and 3.20
[mu]g/L (spring samples) in the Des Plaines River, which is dominated
by wastewater. However, these compounds were not detected further
downstream in the Illinois River (the Des Plaines and Kankakee Rivers
combine to form the Illinois R.), which receives much less WWTF
effluent (Ref. 25).
More extensive surveys of NPEs in U.S. waterways have also been
undertaken:
A comprehensive monitoring study of NP and NPEs in 30 U.S.
rivers sponsored by the Chemical Manufacturers Association (now the
American Chemistry Council (ACC)), was designed with the stated goal of
characterizing the upper range of environmental NP and NPE
concentrations in U.S. rivers (Refs. 21 and 49). This study found
average levels of NP(3-17)EO (combined), NP2EO, NP1EO, and NP of 2.0
[mu]g/L, 0.10 [mu]g/L, 0.09 [mu]g/L, and 0.12 [mu]g/L, respectively, in
water samples. The highest levels found were approximately 15 [mu]g/L
for NP(3-17)EO and 1 [mu]g/L for each of the other substances measured.
Most of the water samples contained non-detectable levels of NP and
NPEs (level of detection approximately 0.1 [mu]g/L for NP, NP1EO and
NP2EO, and 1.6 [mu]g/L for total NP(3-17)EO) (Ref. 21).
In another study of 139 U.S. streams in 30 states
conducted by the U.S. Geological Survey, NP, NP1EO, and NP2EO were 3 of
95 organic wastewater contaminants sampled for. Samples were taken
downstream of areas anticipated to contain pollution from intense
urbanization and livestock production. NP was one of the most
frequently detected compounds (51%). NP1EO and NP2EO were also
detected, though slightly less frequently (46% and 37%, respectively).
For NP, NP1EO, and NP2EO the maximum detected concentration levels were
40 [mu]g/L, 20 [mu]g/L, and 9 [mu]g/L, respectively, with the median
estimated concentration of each substance being about 0.8 [mu]g/L for
NP, and 1 [mu]g/L for NP1EO and NP2EO (Ref. 18).
NP and NPEs have also been reported in sediments. Because of their
significant hydrophobicity, which increases with decreasing chain
length, and relative resistance to degradation, which also increases
with decreasing chain length, NPEs and especially NP and the short-
chain NPEs tend to preferentially partition from water and accumulate
in sediments at levels much higher than those reported in water (Refs.
3, 4, 6, 26, and 27). For example, Naylor et al. (1992) found that in
sediment samples NP and NP1EO predominated (average levels of 162
[mu]g/kilogram (kg) and 18.1 [mu]g/kg, respectively), with the highest
sediment levels being about 3,000 [mu]g/kg for NP and 175 [mu]g/kg for
NP1EO (Ref. 21). Bennett and Metcalfe (1998, 2000) found NP to be
widely distributed in lower Great Lakes sediments with concentrations
as high as 37,000 [mu]g/kg in sediments near sewage treatment plants
(Refs. 28 and 29). Rice et al.
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(2003) measured sediment concentrations of NPEs and NP of 1,020 [mu]g/
kg dry weight in the Cuyahoga River, Ohio (Combined NP and NP(1-5)EO)
(Ref. 22). Furthermore, in contrasting their observations with other
published results, Rice et al. (2003) concluded that sediment levels of
NPEs in the Cuyahoga River are low compared to some other areas; they
noted, for example much higher levels were reported for the Detroit,
Rouge, and Chicago Rivers (e.g., maximum reported levels of NP and/or
NPEs from 49,000 to 60,000 [mu]g/kg). In a marine/estuarine environment
(Bernard Bayou, Mississippi), sediment concentrations ranged from 78 to
915 [mu]g/kg for NP (average 509 [mu]g/kg), and 5 to 89 [mu]g/kg for
NP1EO (average 11 [mu]g/kg) (Ref. 49).
In WWTFs the degradation process of NPEs may vary depending on the
efficiency of the WWTF and even according to the season of the year.
However, even in cases where biodegradation of the long-chain NPEs is
slowed (e.g., in winter or where wastewater treatment is poor), studies
indicate that NP and the short-chain NPEs are still the predominant
substances found after treatment (Refs. 3, 9, and 30).
D. What are the Issues for Comment Concerning Aquatic Toxicity Testing?
EPA has identified a number of issues, on which it is specifically
soliciting comment in regard to proposing aquatic toxicity testing for
NP and NPEs. However, this is not intended as an exclusive list of
issues and commenters are encouraged to provide comments on any issue
pertaining to the aquatic toxicity of NP and NPE short-chain isomers,
and the testing that may be necessary or appropriate. The issues on
which EPA is specifically soliciting comments are:
Selection of test substance identity and purity;
Selection of extent of acute and chronic aquatic tests and
test species;
Selection of particular aquatic toxicity tests and test
species for NPEs;
Testing of NP in a saltwater fish species;
Testing of NP and NPEs in freshwater and marine sediment;
and
Proposed testing for NP1EO and NP2EO as it relates to
development of water quality criteria.
In the discussions in this unit, EPA indicates its preliminary
considerations regarding these issues:
1. Selection of test substance identity and purity. Currently, the
aquatic toxicity testing EPA is considering would focus on testing NP
and the short-chain NPEs, i.e., nonylphenol with one or two ethoxylates
groups attached. EPA is soliciting comment on the most appropriate
selection and purity of NP and NPEs to test. At this time, considering
presently available data on NP and NPEs, EPA believes that testing of
NP (phenol, 4-nonyl-branched: CAS number 84852-15-3) and NP1EO and/or
NP2EO of 95% purity (laboratory grade) is appropriate for purposes of
sufficiently predicting environmental risks from NP and NPEs as a
chemical category. As noted in Unit II.C., NP1EO, NP2EO and NP occur in
the environment mainly as degradation products of the longer-chain NPEs
and, because of their relative resistance to degradation compared to
the longer-chain NPEs, these short-chain NPEs are commonly found in the
aquatic environment (Refs. 22, 25, and 31). NPE toxicity also seems to
increase with decreasing chain length (Refs. 32-34). Available toxicity
studies indicate that the short-chain NPEs, for example, are about 100
times more toxic than the long-chain NPEs, and NP appears to be about
1.5 to two times more toxic than the short-chain NPEs (Refs. 3 and 35).
In the environment, the alkylphenols are combinations of various
isomers and congeners, including NP, which is a mix of substances in
which the nonyl group may be branched or linear and which may be
attached to the phenol ring ortho, meta, or para to the hydroxyl group
(Ref. 4). The most predominant commercial NP substance for which EPA
has developed aquatic life ambient water quality criteria is phenol, 4-
nonyl-branched (CAS number 84852-15-3), but tests on NP with CAS number
25154-52-3 (phenol, nonyl) were also used in developing these criteria
(Ref. 4). Determining which test substance to specify for testing is a
more complex issue in regard to the short-chain ethoxylates. On the
TSCA inventory, both NP1EO (CAS number 27986-36-3) and NP2EO (CAS
number 27176-93-8) are described with the term ``unspecified isomer
lot.'' EPA has also identified NP1EO (CAS number 104-35-8) and NP2EO
(CAS number 27176-93-8) whose name and CAS numbers indicate linear
forms of these substances (although the actual structure may be
branched); the NP1EO so identified is not present on the TSCA
inventory; the NP2EO is.
With regard to who might ultimately be responsible for testing of
these substances, the approach that EPA is considering proposing is
that all manufacturers and processors of NP and NPEs of any chain
length would be responsible for the testing. However, EPA solicits
comment on such an approach.
2. Selection of extent of acute and chronic aquatic tests and test
species. For substances that are broadly distributed in the
environment, as is the case for NP and NPEs, EPA's OPPT, in assessing
hazard to substances which are considered highly toxic, and EPA's
Office of Water (OW), in determining ambient water quality criteria,
typically review test data for both freshwater and saltwater organisms
(fish, invertebrates, and plants) in order to adequately predict
aquatic toxicity to environmental species (Refs. 36-38 and 50 to 51).
To further elucidate the aquatic toxicity of NP and NPEs, EPA is
considering proposing a number of aquatic and sediment toxicity tests
in fish, invertebrates and algae. Specific testing is discussed in more
detail in this unit.
The petitioners requested testing of mixtures. EPA responded that,
for purposes of evaluating the effects of mixtures of NP and NPEs, an
assumption of additive toxicity was reasonable and a more pragmatic way
to account for the toxicity of mixtures of these substances to aquatic
organisms (Refs. 1 and 2). This is because if effects are additive, the
effects of mixtures can be effectively predicted from toxicity studies
done on single substances. Two recent papers have examined the issue of
additive toxicity for NP and NPEs. These papers present test results
for mixtures of NP and the short-chain NPEs on fathead minnows and two
species of daphnids, planktonic freshwater crustaceans also known as
water fleas (Refs. 52 and 53). TenEyk and Markee (2007) concluded from
testing with fathead minnows (Pimephales promelas) and water fleas
(Ceriodaphnia dubia) that both potential additivity and synergism
(where toxicity of the mixture is greater than additive) were observed
(Ref. 52). Conversely, in tests with another water flea species
(Daphnia magna), Sun and Gu (2005) concluded that potential antagonism
(where toxicity of the mixture was less than additive) was seen (Ref.
53). EPA notes that these testing results indicate the substantial
difference in the conclusions regarding the type of interaction
(antagonism vs. additivity vs. synergism) that can potentially occur
due to any number of factors related to biology, chemistry,
experimental variables, etc. However, in considering the limitations
associated with the study designs, EPA notes that, in both studies, the
deviations observed from a simple additivity interaction are
sufficiently small (a factor of approximately two or less) as to make
additivity a reasonable
[[Page 28658]]
assumption for any evaluation of these compounds at this time. Two-fold
is well within the range of inter-laboratory variability that one might
expect in the results of testing a single chemical in the same species
from one laboratory to another, and is far lower than the variability
observed for toxicity of the same chemical to different aquatic
species, which, in the case of NP, can exceed 100-fold (Refs. 32 and
55).
Therefore, it is EPA's current view that testing of individual NP
and NPE substances as EPA is considering proposing in this ANPRM, will
provide sufficient information needed to evaluate the toxicity of
mixtures of these substances (for example, by using a toxic equivalent
factor (TEF) approach). However, EPA is soliciting comment on whether
testing intended to address the potential for additive toxicity should
be conducted consistent with the protocol used in the TenEyck and
Markee study (Ref. 52), as suggested by the petitioners. EPA is also
soliciting comment on alternative approaches to investigating the
potential toxicity of mixtures of NP and the various short-chain NPEs.
3. Selection of particular aquatic toxicity tests and test species
for NPEs. To further determine the aquatic toxicity of NPEs, EPA is
considering proposing chronic testing in freshwater fish, both warm and
coldwater species (e.g., fathead minnow, Pimephales promelas, and
rainbow trout, Oncorhynchus mykiss); chronic testing in a freshwater
invertebrate (e.g., Daphnia magna); and testing in freshwater algae
(e.g., Pseudokirchneriella subcapitata; formerly Selenastrum
capricornutum). EPA is also considering testing in a saltwater fish
(e.g., sheepshead minnow, (Cyprinodon variegatus), chronic testing in a
saltwater invertebrate (e.g., mysid shrimp, Mysidopsis bahia), and
testing in saltwater algae (e.g., Skeletonema costatum)). In order to
set appropriate test concentration levels, and to develop-acute-to-
chronic ratios, EPA is also considering acute testing be performed by
the same laboratory doing the chronic fish and invertebrate testing.
4. Testing of NP in a saltwater fish species. EPA has developed
water quality criteria (WQC) for NP (Ref. 4). However, as EPA noted in
that document, the WQC for NP (CAS number 84852-15-3) was developed
without adequate chronic toxicity data for a saltwater fish species.
EPA is therefore considering proposing that acute and chronic toxicity
testing of NP be performed in a single laboratory in order to fill that
missing chronic toxicity data need, and also to calculate an acute-to-
chronic ratio. EPA is considering proposing that the sheepshead minnow
be the test species for this possible testing requirement.
5. Testing of NP and NPEs in freshwater and marine sediment. EPA
noted in its response to the NP-NPE TSCA section 21 petition that
information on the toxicity of NP in sediment, in both freshwater and
marine/estuarine habitats, is limited and that it would consider
additional testing under TSCA section 4 to obtain needed data. EPA is
considering proposing acute and chronic sediment toxicity testing in
freshwater and marine species of benthic invertebrates for NP, NP1EO,
and/or NP2EO, where adequate data are lacking. Specifically, EPA is
considering proposing the amphipod (Hyalella azteca) as the freshwater
test species (acute and chronic testing) (Ref. 39). EPA is also
requesting, as per the discussion in Unit II.D.2., comment on whether
to require section 4 testing of NPE and NP on a sediment organism,
e.g., Hyalella azteca, in order to fill the information gaps on
additive toxicity. Regarding the marine environment, EPA is considering
proposing testing in two species: acute testing in a marine amphipod
(Rhepoxynius abronius), which, besides being a purely marine species,
has a large data base of toxicity testing available; and acute and
chronic testing in an estuarine amphipod, (Leptocheirus plumulosus)
(Refs. 40 and 41). EPA would consider using the results from both
Leptocheirus and Rhepoxynius to estimate chronic toxicity to
Rhepoxynius, for which a chronic toxicity test method is not available.
6. Proposed testing for NP1EO and NP2EO as it relates to
development of water quality criteria. EPA has derived recommended
ambient water quality criteria (AWQCs) only for NP (Ref. 4). An EPA-
recommended AWQC is a level of a pollutant or other measurable
substance in water that, when met, will protect aquatic life and/or
human health. EPA publishes recommended AWQCs pursuant to Section
304(a) of the Clean Water Act, which directs EPA to publish criteria
accurately reflecting the latest scientific knowledge on such factors
as ``the kind and extent of all identifiable effects . . . expected
from the presence of pollutants in any body of water.'' 33 U.S.C
1314(a)(1)(A). As discussed in this unit, NP is more persistent and
toxic, and frequently more abundant in the environment, than NPEs.
Because of its relative persistence and toxicity compared to NPEs, most
research has focused on NP as a chemical substance of concern. For
these same reasons, development of data for NP was considered of
priority importance for derivation of AWQCs. (Development of AWQC
generally involves extensive and specific test data (Refs. 4 and 38)).
In this ANPRM, EPA is considering proposing more limited testing that
would sufficiently characterize the toxicity of NP1EO and NP2EO to
enable a reasoned assessment of risk from these substances. However,
the data developed could also be useful to OW should they pursue
development of NPE AWQCs.
E. What are the Issues Concerning Exposure of NPEs to Industrial
Laundry Workers?
The petitioners requested that EPA conduct an epidemiology study of
industrial laundry workers who may be exposed to NP and NPEs in
detergents. As noted in EPA's response to the petition, before an
epidemiology study can be effectively designed or conducted, there
needs to be 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. 42). Given the low volatility (Ref. 43) and negligible dermal
absorption of NP and NPE (Ref. 44), EPA does not expect that where
liquid detergents are used these industrial laundry operations will
present a significant exposure potential to workers. However, as agreed
to in the Settlement Agreement (Ref. 57), EPA is soliciting comment on
that conclusion in this ANPRM. Additionally, EPA is soliciting
information on specific circumstances or scenarios which may result in
workers being exposed. Examples included exposure scenarios resulting
from spills. EPA would be interested in the extent to which those types
of exposures would present risks to workers. EPA would also be
interested in receiving comments on the best ways to obtain data or
information on such exposures.
For the approximately 10% of industrial laundry operations and an
unknown number of institutional laundry operations that may use
powdered detergent, EPA believes 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. 45).
As these concerns are based on estimates, not actual exposure
monitoring data, they would not support a conclusion that there are
sufficient exposures to warrant an
[[Page 28659]]
epidemiology study. However, EPA considers that obtaining additional
exposure information may be warranted to reasonably assess the
potential for risk associated with this exposure scenario in
particular.
EPA has examined the regulatory status, as well as other studies,
of various components of detergents that are used in consumer,
industrial, and institutional laundry operations (Refs. 46, 47, and
48). Exposure limits for subtilisins, enzymes used in detergent
formulations, have been established by the American Conference of
Industrial Hygienists (ACGIH) and the National Institute for
Occupational Safety and Health (NIOSH). Air monitoring to ensure the
levels are maintained is recommended and personal monitoring equipment
for subtilisins or other common enzyme detergents is available (Ref.
47). In addition, the Organization for Economic Co-operation and
Development (OECD) Screening Information Data Set (SIDS) report on
linear alkyl sulfonates, another common laundry detergent component,
suggests that the hazard warnings and routine practices (protective
equipment use and rinsing of residuals from contact) will sufficiently
limit exposure and subsequent absorption (Ref. 48). The potential for
exposure to NP based chemicals in detergents should already be
mitigated by the policies in place for the other detergent components.
However, based on EPA's draft engineering report (Ref. 45), EPA
believes that specific monitoring for NP or NPE, using the analogous
methodology for monitoring enzyme exposure, may be warranted to ensure
that these routine practices are also protecting from NP exposures.
Accordingly, while EPA denied the petitioners' specific request for
an epidemiology study, EPA is soliciting comment on the best means to
obtain information on NP and NPE exposures of laundry workers,
especially where powdered detergents are used (e.g., whether through
requiring an exposure study, workplace exposure monitoring, the
voluntary submission of existing monitoring data, or other means). In
addition, although EPA does not believe it has evidence sufficient to
support the same level of concern for liquid detergents as for powdered
detergents, EPA is soliciting comment on whether and how to obtain data
on specific scenarios that may result in exposure to laundry workers
from liquid detergents, as well as powdered detergents.
F. What is the Agency's Authority for Taking this Action?
EPA is issuing this ANPRM on certain health and environmental
effects testing for certain NP and NPE chemical substances under TSCA
section 4(a) (15 U.S.C. 2603(a)).
Section 2(b)(1) of TSCA (15 U.S.C. 2601(b)) states that it is the
policy of the United States that ``adequate data should be developed
with respect to the effect of chemical substances and mixtures on
health and the environment and that the development of such data should
be the responsibility of those who manufacture [which is defined by
statue to include import] and those who process such chemical
substances and mixtures[.]'' To implement this policy, TSCA section
4(a) provides that EPA shall require by rule that manufacturers and
processors of chemical substances and mixtures conduct testing if the
Administrator finds that:
(1)(A)(i) the manufacture, distribution in commerce, processing,
use, or disposal of a chemical substance or mixture, or that any
combination of such activities, may present an unreasonable risk of
injury to health or the environment,
(ii) there are insufficient data and experience upon which the
effects of such manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture of any combination of
such activities on health or the environment can reasonable be
determined or predicted, and
(iii) testing of such substances or mixture with respect to such
effects is necessary to develop such data; or
(B)(i) a chemical substance or mixture is or will be produced in
substantial quantities, and (I) it enters or may reasonably be
anticipated to enter the environment in substantial quantities or
(II) there is or may be significant or substantial human exposure to
such substance or mixture,
(ii) there are insufficient data and experience upon which the
effects of the manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combination
of such activities on health or the environment can reasonable be
determined or predicted, and
(iii) testing of such substance or mixture with respect to such
effects is necessary to develop such data; and
(2) in the case of a mixture, the effects which the mixture's
manufacture, distribution in commerce, processing, use or disposal
or any combination of such activities may have on health or the
environment may not be reasonably and more efficiently determined or
predicted by testing the chemical substances which comprise the
mixture[.]
(15 U.S.C. 2603(a))
If EPA makes these findings for a chemical substance or mixture,
the Administrator shall require that testing be conducted on that
chemical substance or mixture. The purpose of the testing would be to
develop data about the substance's or mixture's health and
environmental effects for which there is an insufficiency of data and
experience, and which are relevant to a determination that the
manufacture, distribution in commerce, processing, use, or disposal of
the substance or mixture, or any combination of such activities, does
or does not present an unreasonable risk of injury to health or the
environment. (15 U.S.C. 2603(a))
Once the Administrator has made the relevant findings under TSCA
section 4(a), EPA may require any type of health or environmental
effects testing necessary to address unanswered questions about the
effects of the chemical substance. EPA need not limit the scope of
testing required to the factual basis for the TSCA section 4(a)(1)(A)
or (B) findings as long as EPA also finds that there are insufficient
data and experience upon which the effects of the manufacture,
distribution in commerce, processing, use, or disposal of such
substance or mixture or of any combination of such activities on health
or the environment can reasonably be determined or predicted, and that
testing is necessary to develop such data. This approach is explained
in more detail in EPA's TSCA section 4(a)(1)(B) Final Statement of
Policy published in the Federal Register issue of May 14, 1993 (58 FR
28736, 28738-28739) (B Policy).
III. References
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P.; Grader, Z.; McCally, M.; and Frumin, E. 2007. Letter from
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Coalition, Pacific Coast Federation of Fisherman's Associations,
Physicians for Social Responsibility, and UNITE HERE to Stephen
Johnson, Administrator, Environmental Protection Agency. Re: Citizen
Petition to EPA Regarding Nonylphenol and Nonylphenol Ethoxylates. June
5, 2007.
2. EPA. TSCA Section 21 Petition on Nonylphenol and Nonylphenol
Ethoxylates; Response to Citizens' Petition. Notice. Federal Register
(72 FR 50954, September 5, 2007) (FRL-8146-2). Available on-line at
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3. Environment Canada. Canadian Environmental Quality Guidelines
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Scientific Supporting Document. Ecosystem Health: Science-based
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Environment Canada, Ottawa. 189 pp. August 2002.
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4. EPA. 2005. Aquatic Life Ambient Water Quality Criteria--
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Eckroth, D.; Mark, H.F.; Othmer, D.F.; Overberger, C.G., and Seaborg,
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and Consumer Protection. European Chemicals Bureau. 2002. European Risk
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ethoxylates and their use in Canada. World Wildlife Fund Canada,
Toronto.
8. Giger, W.; Brunner, P.H.; and Schaffner, C. 1984. 4-Nonylphenol
in sewage sludge: Accumulation of toxic metabolites from nonionic
surfactants. Science. 225:623-625.
9. Ahel, M.; Hrsak, D.; and Giger, W. 1994a. Aerobic transformation
of short-chain alkylphenol polyethoxylates by mixed bacterial cultures.
Archives of Environmental Contamination and Toxicology. 26:540-548.
10. Ahel, M.; Giger, W.; and Koch, M. 1994b. Behaviour of
alkylphenol polyethoxylates surfactants in the aquatic environment.
Water Research. 28:1131-1142.
11. Naylor, C.G. 1995. Environmental fate and safety of nonylphenol
ethoxylates. Textile Chemist and Colorist. 27:29-33.
12. Komori, K.; Yuji, O.; Yasomima, M.; Suzuki, Y.; and Tanaka, H.
2005. Occurrence of nonylphenol, nonylphenol ethoxylate surfactants and
nonylphenol carboxylic acids in wastewater in Japan. Technology. 305-
310.
13. Maguire, R.J. 1999. Review of the persistence of nonylphenol
and nonylphenol ethoxylates. Water Quality Research Journal of Canada.
34:37-78.
14. Staples, C.A.; Williams, J.B.; Blessing R.L.; and Varineau,
P.T. 1999. Measuring the biodegradability of nonylphenol ether
carboxylates, octylphenol ether carboxylates and nonylphenol.
Chemosphere. 38:2029-2039.
15. Staples, C.A.; Naylor, C.G.; Williams, J.B.; and Gledhill, W.E.
2001. Ultimate biodegradation of alkylphenol ethoxylate surfactants and
their biodegradation intermediates. Environmental Toxicology and
Chemistry. 20:2450-2455.
16. Bennie, D.T.; Sullivan, C.A.; Lee, H.; Peart, T.E.; and
Maguire, R.J. 1997. Occurrence of alkylphenols and alkylphenol mono-
and di-ethoxylates in natural waters of the Laurentian Great Lakes
basin and the upper St. Lawrence River. Science of the Total
Environment. 193:263-275.
17. Bennie, D.T. 1999. Review of the environmental occurrence of
alkylphenols and alkylphenol ethoxylates. Water Quality Research
Journal of Canada. 34:79-122.
18. Kolpin, D.W.; Furlong, E.T.; Meyer, M.T.; Thurman, E.M.; Zaugg,
S.D.; Barber, L.B.; and Buxton, H.T. 2002. Pharmaceuticals, hormones
and other organic wastewater contaminants in U.S. streams, 1999-2000: A
national reconnaissance. Environmental Science and Technology. 36:1202-
1211.
19. Lee, H.-B. and Peart, T.E. 1995. Determination of 4-nonylphenol
in effluent and sludge from sewage treatment plants. Analytical
Chemistry. 67:1976-1980.
20. Naylor, C.G. Environmental fate of alkylphenol ethoxylates.
Soap Cosmetics Chemical Specialties. August 1992.
21. Naylor, C.G.; Mieure, J.P.; Adams, W.J.; Weeks, J.A.; Castaldi,
F.J.; Ogle, L.D.; and Romano, R.R. 1992. Alkylphenol ethoxylates in the
environment. Journal of the American Oil Chemists' Society. 69:695-708.
22. Rice, C.; Schmitz-Afonso, I.; Loyo-Rosales, J.; Link, E.;
Thoma, R.; Fay, L.; Altfater, D.; and Camp, M. 2003. Alkylphenol and
alkylphenol ethoxylates in carp, water, and sediment from the Cuyahoga
River, Ohio. Environmental Science and Technology. 37:3747-3754.
23. Sabik, H.; Proulx, S.; Gagne, F.; Blaise, C.; Marcogliese, D.;
Chiron, S.; and Jeannot, R. 2000. Estrogenic compounds in the St.
Lawrence River near Montral: occurrence and bioaccumulation by mussels
(Elliptio complinata). Annual meeting of the International Association
for Great Lakes Research (IAGLR). May 22-26, 2000. Cornwall, Ontario.
24. Sekela, M.; Brewer, R.; Moyle, G.; and Tuominen, T. 1999.
Occurrence of an environmental estrogen (4-nonylphenol) in sewage
treatment plant effluent and the aquatic receiving environment. Water
Science and Technology. 39:217-220.
25. Barber, L.B.; Brown, B.K.; and Zaugg, S.D. 2000. Potential
endocrine disrupting organic chemicals in treated municipal wastewater
and river water. Pp. 97-123. In: Keith, L.H.; Jones-Lepp, T.L.; and
Needham, L.L. (eds). Environmental Endocrine Disruptors, ACS Symposium
Series 747. American Chemical Society, Washington, DC.
26. John, D.M.; House, W.A.; and White, G.F. 2000. Environmental
fate of nonylphenol ethoxylates: differential adsorption of homologs to
components of river sediment. Environmental Toxicology and Chemistry.
19:293-300.
27. Bennie, D.T.; Sullivan, C.A.; Lee, H.-B.; and Maguire, R.J.
1998. Alkylphenol polyethoxylates metabolites in Canadian sewage
treatment plant waste streams. Water Quality Research Journal of
Canada. 33:231-252.
28. Bennet, E.R. and Metcalfe, C.D. 1998. Distribution of
alkylphenol compounds in Great Lakes sediments, United States and
Canada. Environmental Toxicology and Chemistry. 17:1230-1235.
29. Bennet, E.R. and Metcalfe, C.D. 2000. Distribution of
degradation products of alkylphenol ethoxylates near sewage treatment
plants in the lower Great Lakes, North America. Environmental
Toxicology and Chemistry. 19:784-792.
30. Loyo-Rosales, J.E.; Rice, C.P.; and Torrents, A. 2007. Fate of
octyl- and nonylphenol ethoxylates and some carboxylated derivatives in
three American wastewater treatment plants. Environmental Science and
Technology. 41:6815-6821.
31. Staples, C.; Mihaich, E.; Carbone, J.; Woodburn, K.; and
Klecka, G. 2004. A weight of evidence of the chronic ecotoxicity of
nonylphenol ether carboxylates and nonylphenol. Human and Ecological
Risk Assessment. 10:999-1017.
32. Servos, M.R. 1999. Review of the aquatic toxicity, estrogenic
responses and bioaccumulation of alkylphenols and alkylphenol
polyethoxylates. Textile Chemist and Colorist. 27:29-33.
33. Yoshimura, K. 1986. Biodegradation and fish toxicity of
nonionic surfactants. Journal of the American Oil Chemists' Society.
63:1590-1596.
34. Staples, C.A.; Weeks, J.; Hall, J.F.; and Naylor, C.G. 1998.
Evaluation of aquatic toxicity and bioaccumulation of C8- and C9-
alkylphenol polyethoxylates. Environmental Toxicology and Chemistry.
17:2470-2480.
35. Canadian Council of Ministers of the Environment. 2001.
Canadian water quality guidelines for the protection of aquatic life:
Nonylphenol and its ethoxylates. Canadian Council of Ministers of the
Environment. Winnipeg, Ontario.
36. Zeeman, M. and Gilford, J. 1993. Environmental fate and safety
of
[[Page 28661]]
nonylphenol ethoxylates. Pp. 7-21. In: Landis W.G.; Hughes, J.S.; and
Lewis, M.A. (eds). Environmental Toxicology and Risk Assessment, ASTM
STP 1179. American Society for Testing and Materials, Philadelphia,
Pennsylvania.
37. Smrchek, J.C. and Zeeman, M.G. 1998. Assessing risks to
ecological systems from chemicals. Pp. 24-90. In: Callow, P. (ed).
Handbook of Environmental Risk Assessment and Management. Blackwell
Science Ltd., Oxford, U.K.
38. Stephan, C.E.; Mount, D.I.; Hansen, D.J.; Gentile, J.H.;
Chapman, G.A.; and Brungs, W.A. 1985. Guidelines for deriving numerical
national water quality criteria for the protection of aquatic organisms
and their uses. Available on-line at http://www.epa.gov/waterscience/criteria/library/85guidelines.pdf.
39. EPA. 2000. Methods for measuring the toxicity and
bioaccumulation of sediment-associated contaminants with freshwater
invertebrates. Second Edition. Office of Research and Development and
Office of Water. EPA/600/R-99/064.
40. EPA. 1994. Methods for measuring the toxicity of sediment-
associated contaminants with estuarine and marine amphipods. Office of
Research and Development. EPA/600/R-94/025.
41. EPA. 2001. Methods for assessing the chronic toxicity of marine
and estuarine sediment-associated contaminants with the amphipod
Leptocheirus plumulosus First Edition. Office of Research and
Development and Office of Water. EPA/600/R-01/020.
42. Uniform and Textile Service Association (UTSA) and Textile
Rental Services Association of America (TRSA) 2007. Letter from Tony
Wagner, Director, Environmental and Government Affairs, Uniform and
Textile Service Association and Robert Schaeffer, 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. July 25, 2007.
43. EPA. 2007. 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 [squ] N-31.5 Surfactant (2005) and EPIWIN
[SRC CORP.] Program Estimates (EPI--est.doc)). August 14, 2007.
44. 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 rate skin. Toxicology and Industrial Health.
16:49-57.
45. EPA. 2007. Draft Engineering Report of Nonylphenol (NP) and
Nonylphenol Ethoxylates (NPEs) in Response to Section 21 Petition. EPA,
Office of Pollution, Prevention and Toxics, Economics, Exposure and
Technology Division, Chemical Engineering Branch. July 18, 2007. 15pp.
46. Occupational Safety and Health Administration (OSHA),
Department of Labor. OSHA Chemical Sampling Information: Subtilisins
data sheet. September 19, 2007. Naylor, C.G. 1995. Environmental fate
and safety of nonylphenol ethoxylates. Available on-line at http://www.osha.gov/dts/chemicalsampling/data/CH_268300.html.
47. Warburton, J. 2006. Monitoring Individual Exposures to Enzymes
in the Workplace. Industrial Hygiene News. May 2006.
48. OECD. 2005. SIDS Report on Linear Alkylbenzene Sulfonates.
Section 2.3 Human Exposures. Pp. 24-90. In: SIDS Initial Assessment
Report for 20\th\ SIAM. April 2005. United Nations Environment
Programme, London, U.K.
49. Radian Corp. 1990. Nonylphenol and nonylphenol ethoxylates in
river water and bottom sediments: January 1989-August 1990. Final
Report to Alkylphenol and Ethoxylates Panel, Chemical Manufacturers
Association.
50. Smrchek, J.; Clements, R.; Morcock, R; and Rabert, W. 1993.
Assessing ecological hazard under TSCA: methods and evaluation of data.
Pp. 22-39. In: Landis W.G.; Hughes, J.S.; and Lewis, M.A. (eds).
Environmental Toxicology and Risk Assessment, ASTM STP 1179. American
Society for Testing and Materials, Philadelphia, Pennsylvania.
51. Smrchek, J.; Zeeman, M.; and Clements, R. Ecotoxicology and the
assessment ecological of chemicals at the US EPA's Office of Pollution
Prevention and Toxics: current activities and future needs. Pp. 127-
158. In: Pratt, J.R.; Bowers, N.; and Stauffer, J.R. (eds). Making
Environmental Science, Ecoprint, Portland, OR. 271 pp. 1995.
52. TenEyck, M.C.; and Markee, T.P. 2007. Toxicity of nonylphenol,
nonylphenol monoethoxylate, and nonylphenol diethoxylate and mixtures
of these compounds to Pimephales promelas (fathead minnow) and
Ceriodaphnia dubia. Archives of Environmental Contamination and
Toxicology. 53:599-606.
53. Sun, H. and Gu, X. 2005. Comprehensive toxicity study of
nonylpheno and short-chain nonylphenol polyethoxylates on Daphnia
magna. Bulletin of Environmental Contamination and Toxicology. 75:677-
683.
54. Zeeman, M.; Nabholz, J.V.; and Clements, R.G. 1993. The
development of SAR/QSAR for use under EPA's Toxic Substances Control
Act (TSCA): an introduction. Pp. 523-539. In: Gorsuch, J.W.; Dwyer,
F.J.; Ingersoll, C.G.; and LaPoint, T.W. (eds). Environmental
Toxicology and Risk Assessment-2\nd\ Volume, ASTM STP 1216. American
Society for Testing and Materials, Philadelphia, Pennsylvania.
55. Vaal, M.A.; Van Leeuwen, C.J.; Hoekstra, J.A.; and Hermens,
J.L. 2000. Variation in sensitivity of aquatic species to toxicants:
practical consequences for effect assessment of chemical substances.
Environmental Management. 25:415-423.
56. Complaint for Declaratory and Injunctive Relief, Sierra Club et
al. v. Johnson, U.S. District Court for the Northern District of
California, Case No. C07-05435-MCC, October 24, 2007.
57. Settlement Agreement, Sierra Club et al. v. Johnson, U.S.
District Court for the Northern District of California, Case No. C07-
05435-MCC, December 30, 2008.
IV. Do Any Statutory and Executive Order Reviews Apply to This Action?
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), it has been determined that this
is a ``significant regulatory action'' because the initiation of a new
rulemaking proceeding may raise novel legal or policy issues.
Accordingly, EPA submitted this action to the Office of Management and
Budget (OMB) for review under Executive Order 12866 and any changes
made in response to OMB recommendations have been documented in the
docket for this action.
Because this action does not propose or impose any requirements,
other statutory and Executive Order reviews that apply to rulemaking do
not apply. Should EPA subsequently determine to pursue a rulemaking,
EPA will address the statutes and Executive Orders as applicable to
that rulemaking.
Nevertheless, the Agency welcomes comments and/or information that
would help the Agency to assess any of
[[Page 28662]]
the following: The potential impact of a rule on small entities
pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.); availability of voluntary consensus standards pursuant to
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note); environmental health or safety effects on children pursuant to
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19985, April 23,
1997); or human health or environmental effects on minority or low-
income populations pursuant to Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994). The Agency will
consider such comments during the development of any subsequent
rulemaking.
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals, Hazardous substances,
Nonylphenol, Nonylphenol ethoxylates, Reports and recordkeeping
requirements.
Dated: June 10, 2009.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. E9-14250 Filed 6-16-09; 8:45 am]
BILLING CODE 6560-50-S