TSCA Section 21 Petition on Nonylphenol and Nonylphenol Ethoxylates; Response to Citizens’ Petition, 50954-50960 [E7-17542]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 72, Number 171 (Wednesday, September 5, 2007)]
[Notices]
[Pages 50954-50960]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17542]


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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 https://
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 https://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 https://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 https://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 https://
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 https://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 https://
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 https://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