Chlorinated Phosphate Ester (CPE) Cluster; TSCA Section 21 Petition; Reasons for Agency Response, 17601-17613 [2017-07404]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 82, Number 69 (Wednesday, April 12, 2017)]
[Proposed Rules]
[Pages 17601-17613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07404]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2017-0038; FRL-9961-04]


Chlorinated Phosphate Ester (CPE) Cluster; TSCA Section 21 
Petition; Reasons for Agency Response

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition; reasons for Agency response.

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SUMMARY: This document provides the reasons for EPA's response to a 
petition it received under the Toxic Substances Control Act (TSCA). The 
TSCA section 21 petition was received from Earthjustice, Natural 
Resources Defense Council, Toxic-Free Future, Safer Chemicals, Healthy 
Families, BlueGreen Alliance, and Environmental Health Strategy Center 
on January 6, 2017. The petitioners requested that EPA issue an order 
under TSCA section 4, requiring that testing be conducted by 
manufacturers and processors of chlorinated phosphate esters (``CPE''). 
The CPE Cluster is composed of tris(2-chloroethyl) phosphate (``TCEP'') 
(CAS No. 115-96-8), 2-propanol, 1-chloro-, phosphate (``TCPP'') (CAS 
No. 13674-84-5), and 2-propanol, 1,3- dichloro-, phosphate (``TDCPP'') 
(CAS No. 13674-87-8). After careful consideration, EPA denied the TSCA 
section 21 petition for the reasons discussed in this document.

DATES: EPA's response to this TSCA section 21 petition was signed April 
6, 2017.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Hannah Braun, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-5614; email 
address: braun.hannah@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may, 
however, be of interest to those persons who are or may manufacture or 
process the chemicals tris(2-chloroethyl) phosphate (``TCEP'') (CAS No. 
115-96-8), 2-propanol, 1-chloro-, phosphate (``TCPP'') (CAS No. 13674-
84-5), and 2-propanol, 1,3- dichloro-, phosphate (``TDCPP'') (CAS No. 
13674-87-8). Since other entities may also be interested, the Agency 
has not attempted to describe all the specific entities that may be 
affected by this action.

B. How can I access information about this petition?

    The docket for this TSCA section 21 petition, identified by docket 
identification (ID) number EPA-HQ-OPPT-2017-0038, is available at 
https://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW., Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information 
about the docket available at https://www.epa.gov/dockets.

II. TSCA Section 21

A. What is a TSCA section 21 petition?

    Under TSCA section 21 (15 U.S.C. 2620), any person can 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 4 or 5(e) or (f). A TSCA section 21 petition must set forth the 
facts that are claimed to establish the necessity 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. 
A petitioner 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. Legal standard regarding TSCA section 21 petitions. Section 
21(b)(1) of TSCA requires that the petition ``set forth the facts which 
it is claimed establish that it is necessary'' to issue the rule or 
order requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21 implicitly 
incorporates the statutory standards that apply to the requested 
actions. Accordingly, EPA has relied on the standards in TSCA section 
21 and in the provisions under which actions have been requested to 
evaluate this TSCA section 21 petition. In addition, TSCA section 21 
establishes standards a court must use to decide whether to order EPA 
to initiate an order 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).
    2. Legal standard regarding TSCA section 4 rules. EPA must make 
several findings in order to issue a rule or order to require testing 
under TSCA section 4(a)(1)(A)(i). In all cases, EPA must find that 
information and experience are insufficient to reasonably determine or 
predict the effects of a chemical substance on health or the 
environment and that testing of the chemical substance is necessary to 
develop the missing information. 15 U.S.C. 2603(a)(1). In addition, EPA 
must find that the chemical substance may present an unreasonable risk 
of injury under section 4(a)(1)(A)(i). Id. If EPA denies a petition for 
a TSCA section 4 rule or order and the petitioners challenge that 
decision, TSCA section 21 allows a court to order EPA to initiate the 
action requested by the petitioner if the petitioner demonstrates to 
the satisfaction of the court by a preponderance of the evidence in a 
de novo proceeding that findings very similar to those described in 
this unit

[[Page 17602]]

with respect to a chemical substance have been met.

III. Summary of the TSCA Section 21 Petition

A. What action was requested?

    On January 6, 2017, Earthjustice, Natural Resources Defense 
Council, Toxic-Free Future, Safer Chemicals, Healthy Families, 
BlueGreen Alliance, and Environmental Health Strategy Center petitioned 
EPA to issue an order under TSCA section 4(a)(1), 90 days after the 
petition was filed, requiring that testing be conducted by 
manufacturers and processors of the chlorinated phosphate esters 
(``CPE'') Cluster composed of tris(2-chloroethyl) phosphate (``TCEP'') 
(CAS No. 115-96-8), 2-propanol, 1-chloro-, phosphate (``TCPP'') (CAS 
No. 13674-84-5), and 2-propanol, 1,3- dichloro-, phosphate (``TDCPP'') 
(CAS No. 13674-87-8) (Ref. 1).

B. What support do the petitioners offer?

    The petitioners cite to section 4(a)(1) of TSCA, which requires EPA 
to direct testing on a chemical substance or mixture if the 
Administrator finds the following criteria are met:
    1. 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.
    2. There is insufficient information and experience upon which the 
effects of such 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.
    3. Testing is necessary to develop such information.
    The petitioners assert that the CPE Cluster chemicals ``may present 
an unreasonable risk of injury to health or the environment'' because 
there is substantial evidence that chemicals in the CPE Cluster may be 
toxic, including:
     EPA's TSCA Work Plan Chemical Problem Formulation and 
Initial Assessment--Chlorinated Phosphate Ester Cluster Flame 
Retardants (heretofore referred to as Problem Formulation and Initial 
Assessment), which cites multiple mammalian toxicity studies showing 
adverse effects caused by the cluster members such as reproductive and 
developmental effects, neurological effects, liver, kidney and thyroid 
effects and cancer (for certain cluster members) (Refs. 2-7).
     EPA's Problem Formulation and Initial Assessment, which 
also states that ecological toxicity from exposure to TCEP and TDCPP 
was exhibited in acute tests with fish resulting in loss of 
coordination, edema, darker pigmentation and hyperventilation (Ref. 2).
     EPA's Design for the Environment in which the Agency 
conducted a hazard assessment of the chemicals in the CPE cluster and 
found that each of the three cluster members are considered a high 
hazard for more than one human health effect, as well as for aquatic 
toxicity, based on empirical data. Additionally, TCPP and TDCPP are 
considered to be highly persistent (Ref. 8).
     The state of California finds TDCPP to be a ``known 
carcinogen,'' and in 2011 California added TDCPP to the list of 
chemicals requiring warning labels under California Proposition 65 law 
(Ref. 9, 10).
     California's Proposition 65 list of chemicals where TCEP 
was ``known to the State to cause cancer'' in 1992 (Ref. 11).
     The European Union (EU) classifying TCEP as a ``Substance 
of Very High Concern'' based on reproductive toxicity (Ref. 12).
     California's Safer Consumer Products program listing TCPP 
as a candidate chemical based on carcinogenicity (Ref. 13).
    The petitioners assert there are CPE Cluster chemicals exposure to 
humans and the environment based on the following information provided 
in EPA's Problem Formulation and Initial Assessment (Ref. 2).
     Several studies of U.S. drinking water where CPEs have 
been detected (Refs. 14-16).
     Numerous studies where concentrations of CPEs in infant 
products such as high chairs, bath mats, car seats, nursing pillows, 
carriers, sofas, and camping tents have been measured (Refs. 17-21).
     Small children may have additional exposures through 
contact with baby products containing CPEs and via mouthing behaviors 
(Ref. 2).
     A number of published studies where levels of CPEs in 
indoor air and dust have been reported (Refs. 19-49).
     Several studies throughout the United States and abroad 
which reported levels of the CPEs in surface water. Collectively, these 
data indicate high potential for exposures to ecological receptors, and 
in particular, aquatic organisms (Refs. 50-77).
     A study where TCEP, TCPP, and TDCPP have all been measured 
in herring gull eggs from the Lake Huron area (Ref. 78).
    With the evidence of toxicity and exposure the petitioners argue 
that the chemicals in the CPE Cluster meet the criteria for ``may 
present an unreasonable risk of injury to health or the environment.''
    The petitioners also assert there is ``insufficient information'' 
on the CPE Cluster chemicals. They indicate that EPA's Problem 
Formulation and Initial Assessment (Ref. 2) ``identifies seven critical 
data gaps around exposures and hazards of these flame retardants''. 
While EPA disagrees that the Problem Formulation and Initial Assessment 
specifically identifies those which the petitioners assert, the 
petition lists the following seven data gaps around exposures and 
hazard of CPE flame retardants:
    Exposure pathways: Dermal and inhalation;
    2. Hazard: Reproduction and endocrine toxicity;
    3. Exposure: Environmental releases from non-industrial uses;
    4. Exposure: Community and worker exposures from manufacturing, 
processing, industrial and non-industrial uses;
    5. Exposure: Community and worker exposures recycling;
    6. Exposure: Community, worker and environmental exposures from 
disposal; and
    7. Hazard: Toxicity to birds, wildlife, sediment organisms.
    The petitioners argue that the testing recommended in the petition 
is critical to address this allegedly insufficient information and for 
performing any TSCA section 6 risk evaluation of the CPE Cluster 
chemicals.

IV. Disposition of TSCA Section 21 Petition

A. What was EPA's response?

    After careful consideration, EPA denied the petition. A copy of the 
Agency's response, which consists of two letters to the signatory 
petitioners from Earthjustice and Natural Resources Defense Council 
(Ref. 79), is available in the docket for this TSCA section 21 
petition.

B. Background Considerations for the Petition

    EPA published a Problem Formulation and Initial Assessment for the 
CPE Cluster chemicals in August 2015 (Ref. 2). As stated on EPA's Web 
site titled ``Assessments for TSCA Work Plan Chemicals'' (Ref. 80), 
``As a first step in evaluating TSCA Work Plan Chemicals, EPA performs 
problem formulation to determine if available data and current 
assessment approaches

[[Page 17603]]

and tools will support the assessments.'' During development of the 
Problem Formulation and Initial Assessment document for the CPE Cluster 
chemicals, EPA followed an approach developed for assessing chemicals 
under TSCA as it existed at that time. In addition, in Table 2-1 of the 
Problem Formulation and Initial Assessment (Ref. 2), EPA specified, in 
very general terms, the nature and type of information sought to inform 
this particular risk assessment, under the existing TSCA framework.
    Under TSCA prior to the June amendments, EPA performed risk 
assessments on individual uses, hazards, and exposure pathways. The 
approach taken during the TSCA Work Plan assessment effort was to focus 
risk assessments on those conditions of use that were most likely to 
pose concern, and for which EPA identified the most robust readily 
available, existing, empirical data, located using targeted literature 
searches, although modeling approaches and alternative types of data 
were also considered. EPA relied heavily on previously conducted 
assessments by other authoritative bodies and well-established 
conventional risk assessment methodologies in developing the Problem 
Formulation documents. Although EPA identified existing information and 
presented it in the Problem Formulation and Initial Assessment, EPA did 
not necessarily undertake a comprehensive search of available 
information or articulate a range of scientifically supportable 
approaches that might be used to perform risk assessment for various 
uses, hazards, and exposure pathways in the absence of directly 
applicable, empirical data prior to seeking public input. Rather, EPA 
generally elected to focus its attention on the uses, hazards, and 
exposure pathways that appeared to be of greatest concern and for which 
the most extensive relevant information had been identified. (Ref. 2).
    As EPA explains on its Web site, ``Based on on-going experience in 
conducting TSCA Work Plan Chemical assessments and stakeholder 
feedback, starting in 2015 EPA will publish a problem formulation for 
each TSCA Work Plan assessment as a stand-alone document to facilitate 
public and stakeholder comment and input prior to conducting further 
risk analysis. Commensurate with release of a problem formulation 
document, EPA will open a public docket for receiving comments, data or 
information from interested stakeholders. EPA believes publishing 
problem formulations for TSCA Work Plan assessments will increase 
transparency of EPA's thinking and analysis process, provide 
opportunity for public/stakeholders to comment on EPA's approach and 
provide additional information/data to supplement or refine our 
assessment approach prior to EPA conducting detailed risk analysis and 
risk characterization'' (Ref. 80).
    EPA's 2015 Problem Formation and Initial Assessment for the CPE 
Cluster chemicals does not constitute a full risk assessment for the 
chemicals in the CPE Cluster, nor does it purport to be a final 
analysis plan for performing a risk assessment or to present the 
results of a comprehensive search for available data or approaches for 
conducting risk assessments. Rather, it is a preliminary step in the 
risk assessment process, which EPA desired to publish to provide 
transparency and the opportunity for public input. EPA received 
comments from Earthjustice, Natural Resources Defense Council and 
others during the public comment period, which ended in November 2015 
(Ref. 81). After the public comment period, EPA was in the process of 
considering this input in refining the analysis plan and further data 
collection for conducting a risk assessment for the CPE Cluster 
chemicals.
    On June 22, 2016, Congress passed the Frank R. Lautenberg Chemical 
Safety for the 21st Century Act. EPA has interpreted the amended TSCA 
as requiring that forthcoming risk evaluations encompass all 
manufacturing, processing, distribution in commerce, use, and disposal 
activities that the Administrator determines are intended, known, or 
reasonably foreseen (Ref. 83). This interpretation of ``conditions of 
use'' as defined by TSCA section 3(4), has prompted EPA to re-visit the 
scoping and problem formulation for risk assessments under TSCA. Other 
provisions included in the amended TSCA, including section 4(h) 
regarding alternative testing methods, have also prompted EPA to evolve 
its approach to scoping and conducting risk evaluations. The 
requirement to consider all conditions of use in risk evaluations--and 
to do so during the three to three and a half years allotted in the 
statute--has led EPA to more fully evaluate the range of data sources 
and technically sound approaches for conducting risk evaluations. Thus, 
a policy decision articulated in a problem formulation under the pre-
amendment TSCA not to proceed with risk assessment for a particular 
use, hazard, or exposure pathway does not necessarily indicate at this 
time that EPA will need to require testing in order to proceed to risk 
evaluation. Rather, such a decision indicates an area in which EPA will 
need to further evaluate the range of potential approaches--including 
generation of additional test data--for proceeding to risk evaluation. 
EPA is actively developing and evolving approaches for implementing the 
new provisions in amended TSCA. These approaches are expected to 
address many, if not all, of the data needs asserted in the petition. 
Whereas under the Work Plan assessment effort, EPA sometimes opted not 
to include conditions of use for which data were limited or lacking, 
under section 6 of amended TSCA, EPA will evaluate all conditions of 
use and will apply a broad range of scientifically defensible 
approaches--using data, predictive models, or other methods--that are 
appropriate and consistent with the provisions of TSCA section 26, to 
characterize risk and enable the Administrator to make a determination 
of whether the chemical substance presents an unreasonable risk.

C. What was EPA's reason for this response?

    For the purpose of making its decision on the response to the 
petition, EPA evaluated the information presented or referenced in the 
petition and its authority and requirements under TSCA sections 4 and 
21. EPA also evaluated relevant information that was available to EPA 
during the 90-day petition review period that may have not been 
available or identified during the development of EPA's Problem 
Formulation and Initial Assessment (Ref. 2).
    EPA agrees that the manufacture, distribution in commerce, 
processing, use, or disposal of the CPE Cluster chemicals may present 
an unreasonable risk of injury to health or the environment under TSCA 
section 4(a)(1)(A). EPA also agrees that the Problem Formulation and 
Initial Assessment was not comprehensive in scope with regard to the 
conditions of use of the CPE Cluster chemicals, exposure pathways/
routes, or potentially exposed populations. However, the Problem 
Formulation and Initial Assessment was not designed to be 
comprehensive. Rather, the Problem Formulation and Initial Assessment 
was developed under EPA's then-existing process, as explained 
previously. It was a fit-for-purpose document to meet a TSCA Work Plan 
(i.e., pre-Lautenberg Act) need. Going forward under TSCA, as amended, 
EPA will conform its analyses to TSCA, as amended. EPA has explained 
elsewhere how the Agency proposes to conduct prioritization and

[[Page 17604]]

risk evaluation going forward (Refs. 82 and 83). However, EPA does not 
find that the petitioners have demonstrated, for each exposure pathway 
and hazard endpoint presented in the petition, that the information and 
experience available to EPA are insufficient to reasonably determine or 
predict the effects on health or the environment from ``manufacture, 
distribution in commerce, processing, use, or disposal'' (or any 
combination of such activities) of the CPE Cluster chemicals nor that 
the specific testing they have identified is necessary to develop such 
information.
    The discussion that follows provides the reasons for EPA's decision 
to deny the petition based on the finding that for each requested test 
the information on the individual exposure pathways and hazard 
endpoints identified by the petitioners do not demonstrate that there 
is insufficient information upon which the effects of the CPE Cluster 
chemicals can reasonably be determined or predicted or that the 
requested testing is necessary to develop additional information. The 
sequence of EPA's responses follows the sequence in which requested 
testing was presented in the petition (Ref. 1). 1. Dermal and 
Inhalation Exposure Toxicity. a. Dermal toxicity. The petition does not 
set forth facts demonstrating that there is insufficient information 
available to EPA to reasonably determine or predict effects to health 
from dermal exposure to the CPE Cluster chemicals. The toxicokinetics 
test (Organization for Economic Co-operation and Development (OECD) 
Test Guideline 417) (Ref. 84), in vivo absorption test (OECD Test 
Guideline 427) (Ref. 85) and dermal toxicity test (OPPTS Test Guideline 
870.1200) (Ref. 86) requested by the petitioners may not be needed. In 
the Problem Formulation and Initial Assessment, EPA stated that risk 
from the dermal exposure pathway could not be quantified for risk 
assessment because of a lack of route-specific toxicological data, but 
also indicated that an alternative approach, i.e., development of a 
PBPK model for oral, inhalation and dermal routes of exposure would 
provide the ability to perform route-to-route extrapolation. The 
Problem Formulation and Initial Assessment indicated that adequate 
toxicokinetic data would be needed for each route of exposure and that 
these data are lacking for dermal exposures. However, since the 
publication of the Problem Formulation and Initial Assessment document, 
EPA has identified pharmacokinetic data including absorption, 
bioaccessibility and absorption, distribution, metabolism and excretion 
(ADME) data (Refs. 7, 87-96) that could be used to perform route-to-
route extrapolation from oral toxicity studies to predict effects from 
dermal exposure to the CPE Cluster chemicals.
    Furthermore, EPA's use of available existing toxicity information 
reduces the use of vertebrate animals in the testing of chemical 
substances in a manner consistent with provisions described in TSCA 
section 4(h).
    b. Inhalation toxicity. The petition does not set forth facts 
demonstrating that there is insufficient information available to EPA 
to reasonably determine or predict effects to health from inhalation 
exposure to the CPE Cluster chemicals. The toxicokinetics test (OECD 
Test Guideline 417: Toxicokinetics) (Ref. 84) and inhalation toxicity 
test (OPPTS Test Guideline 870.1300: Acute Inhalation Toxicity) (Ref. 
98) requested by the petitioners may not be needed. In the Problem 
Formulation and Initial Assessment, EPA stated that risk from the 
inhalation exposure pathway could not be quantified for risk assessment 
because of a lack of route-specific toxicological data, but also 
indicated that an alternative approach, i.e., development of a PBPK 
model for oral, inhalation and dermal routes of exposure would provide 
the ability to perform route-to-route extrapolation. The Problem 
Formulation and Initial Assessment, indicated that adequate 
toxicokinetic data would be needed for each route of exposure and that 
these data are lacking for inhalation exposures. However, since the 
publication of the Problem Formulation and Initial Assessment, EPA has 
identified toxicological data including, acute toxicity, 
bioaccessibility and ADME data (Refs. 7, 87-89, 93, 99 and 100) that 
could be used in route-to-route extrapolation from oral toxicity 
studies to predict effects from inhalation exposure to the CPE Cluster 
chemicals. As proposed in the Problem Formulation and Initial 
Assessment, CPE Cluster chemicals that are absorbed to and inhaled 
associated with particles, once the particles are in the 
gastrointestinal tract, absorption would be the same as in the oral 
toxicity studies and hence, oral toxicity studies can be used to 
determine or predict effects to health from inhalation exposure to the 
CPE cluster substances. Current literature on bioaccessibility (Ref. 
89) could also be used to refine the estimate of the amount of the CPE 
Cluster chemicals absorbed via ingestion of particles (via inhalation 
and translocation to the gut).
    Furthermore, EPA's use of available existing toxicity information 
reduces the use of vertebrate animals in the testing of chemical 
substances in a manner consistent with provisions described in TSCA 
section 4(h). 2. Reproductive and Endocrine Toxicity. a. Reproductive 
Toxicity. The petition does not set forth facts demonstrating that 
there is insufficient data available to EPA to reasonably determine or 
predict the reproductive toxicity of the CPE Cluster chemicals. The NTP 
Modified One Generation study (Ref. 102) or the alternatively suggested 
in vivo reproductive toxicity screening test (OPPTS 870.3800: 
Reproduction and Fertility Effects) (Ref. 103) based on two-generation 
reproduction toxicity test (OECD Test Guideline 416) (Ref. 104), 
requested by the petitioners, may not be needed. Although EPA states in 
the Problem Formulation and Initial Assessment that ``given uncertainty 
surrounding the impact of long-term exposures and male reproductive 
toxicity, it would not be possible to quantify risks at this time,'' 
EPA now believes, after further review and consideration of existing 
studies, that the Agency could use information identified in the 
Problem Formulation and Initial Assessment, as well as new information 
identified through comprehensive literature searches, data from 
alternative testing approaches, and read-across (in which data for one 
structurally similar chemical can be used to assess the toxicity of 
another) could be used to conduct an assessment of effects of the CPE 
Cluster chemicals on reproduction (Ref. 2). As presented in the Problem 
Formulation and Initial Assessment, EPA identified several studies for 
each chemical in the CPE Cluster to assess reproductive effects. 
Specifically, a multi-generation reproductive and developmental 
toxicity study in mice for TCEP (Ref. 105) and a two-generation 
reproductive and developmental study in rats for TCPP (Ref. 106, test 
data currently listed as CBI) were identified. For TDCPP, a 
reproduction study in male rabbits (Ref. 7), two developmental toxicity 
studies in female rats (Refs. 7 and 107) and a two-year cancer bioassay 
in rats, which included evaluation of effects on reproductive organs 
(Ref. 108), are already available.
    Since the publication of the Problem Formulation Initial Assessment 
document, EPA identified additional reproductive studies. Specifically, 
TCPP has been evaluated in a developmental toxicity study (Ref. 109). 
The results of this study have not yet been released, but are expected 
to be available to EPA

[[Page 17605]]

prior to initiation of a Risk Evaluation for TCPP. EPA has also 
identified studies using alternative animal models and in vitro tests 
that could inform the evaluation of reproductive toxicity (Refs. 110-
117). Finally, given the structural similarity of the three chemicals 
in the CPE Cluster, EPA could consider read-across approaches, using 
data from one chemical to characterize the hazards of another chemical. 
Collectively, the studies identified in the Problem Formulation and 
Initial Assessment document, the studies identified since the release 
of the Problem Formulation and Initial Assessment document, and read-
across approaches, could be used to characterize reproductive toxicity 
for the CPE Cluster chemicals.
    Furthermore, EPA's use of available existing toxicity information 
reduces the use of vertebrate animals in the testing of chemical 
substances in a manner consistent with provisions described in TSCA 
section 4(h).
    b. Endocrine Activity. The petition does not set forth facts 
demonstrating that there is insufficient information available to EPA 
to reasonably determine or predict the effects of the CPE Cluster 
chemicals on endocrine activity. EPA believes that the Larval Amphibian 
Growth and Development Assay (OCSPP 890.2300) (Ref. 118) or the 
alternatively suggested NTP Modified One Generation Study (Ref. 102) 
requested by the petitioners may not be needed. EPA's Problem 
Formulation and Initial Assessment stated that data were conflicting 
with regard to endocrine activity, which made it difficult to make a 
determination in the pre-assessment phase. However, EPA did not 
consider the information to be insufficient; rather EPA intended to 
defer drawing conclusions until the assessment phase when additional, 
comprehensive review of all available data would be conducted.
    A number of studies evaluating thyroidal and other endocrine 
effects are available, including the reproduction and developmental 
toxicity studies described in Unit IV.C.2.a. (Refs. 7, 105, 106 and 
108), as well as studies using alternative animal models and in vitro 
tests (Refs. 110-117) identified since the Problem Formulation and 
Initial Assessment. An evaluation of each study as well as the full 
body of evidence (i.e., weight of evidence) would be undertaken to 
identify endocrine-related hazard concerns. 3. Environmental Releases 
from Non-Industrial and Consumer Uses. The petition does not set forth 
facts demonstrating that there is insufficient information available to 
EPA to reasonably determine or predict effects of the CPE Cluster 
chemicals associated with environmental releases from non-industrial 
and consumer uses nor specifically the potential contribution of down-
the-drain releases of the CPE Cluster chemicals in United States 
waters. EPA agrees with the petitioner's suggestion that existing data 
(e.g., effluent and influent of wastewater) could be used to estimate 
environmental concentrations of the CPE Cluster chemicals from consumer 
and down-the drain uses. Hence, development of sampling plans for 
effluent waters from municipal treatment plants and analytical methods 
for measuring the CPE Cluster chemicals may not be needed.
    While EPA's Problem Formulation and Initial Assessment indicated 
that contributions of non-industrial and consumer uses to water and 
wastewater were not quantifiable, EPA's conceptual model did indicate 
that exposures to water and wastewater (aggregated from all sources) 
would be assessed. EPA agrees, as the petition suggests, that existing 
effluent and influent from wastewater could likely be used to predict 
environmental concentrations of the CPE Cluster chemicals from consumer 
and other down-the drain uses. As identified in the Problem Formulation 
and Initial Assessment, there are over 100 available monitoring studies 
that could be used to characterize concentrations of the CPE Cluster 
chemicals in water and wastewater. Monitoring studies range from 
nationwide studies with larger sample sizes and consistent analytical 
methods such as United States Geological Survey (USGS), to targeted 
studies with generally smaller sample sizes and variable analytical 
methods.
    In addition, several studies from other countries are also 
available to characterize the CPE Cluster chemicals in water and 
wastewater. Since the publication and Problem Formulation and Initial 
Assessment document, an Australian study (Ref. 124), sampled for all 
three members of the CPE Cluster in 11 waste water treatment plants 
(Ref. 124). Another study, identified in the Problem Formulation and 
Initial Assessment, compares influent water concentrations between the 
U.S. and Sweden (Ref. 29) and indicates that U.S. concentration values 
are comparable to Sweden, suggesting that data from Sweden could also 
be considered in a U.S. assessment.
    EPA has identified existing effluent data from municipal treatment 
plants for TCEP and TDCPP from the U.S. Geological Survey National 
Water Information System (Ref. 121) since the publication of the 
Problem Formulation and Initial Assessment document. Several other 
studies also indicate the presence of CPE Cluster chemicals in U.S. 
wastewater (Refs. 55 and 122). One study shows low levels of TCEP in a 
sample from U.S. industrial laundry wastewater (Ref. 123), a potential 
down-the drain contributor to treatment plant effluent. Other 
wastewater samples in the industrial laundry study showed non-detect 
levels of TCEP. EPA agrees with the petitioners that these types of 
data may be especially useful to estimate potential contributions from 
down-the-drain uses to water and wastewater CPE concentrations. Hence, 
as the petitioners suggest, EPA could use a combination of existing 
occurrence data, especially effluent and influent of wastewater from 
municipal treatment plants (e.g., U.S. effluent data and non-U.S. data) 
to determine or predict contributions from non-industrial and consumer 
uses, including the potential contribution of down-the-drain releases. 
EPA believes that the monitoring and effluent data described 
previously, as well as additional data that describes non-industrial or 
consumer sources to wastewater (Ref. 125) that may be identified during 
prioritization of the CPE Cluster for risk evaluation is likely 
sufficient for characterizing risk from exposures to water and 
wastewater and for assessing potential contributions from non-
industrial and consumer down-the-drain releases of the CPE Cluster 
chemicals. As the petitioners point out, this approach of using 
existing monitoring data and especially wastewater effluent data has 
been used by others (i.e., Environment and Climate Change Canada) to 
assess the potential contribution to down-the-drain releases (Ref. 2).

[[Page 17606]]

    EPA believes that the development of analytical methods for the 
determination and quantification of the CPE Cluster chemicals in 
sampled waters and the development of a strategy for sampling effluent 
waters from municipal treatment plants as requested by the petitioners 
is not needed at this time. Analytical methods for TCEP, TCPP and TDCPP 
already exist as evidenced by measurements performed by the USGS and 
other laboratories (Refs. 119 and 120). The petition does not establish 
why these are insufficient. 4. Exposure from manufacturing, processing, 
industrial and non-industrial uses. a. Communities. The petition does 
not set forth facts demonstrating that there is insufficient 
information available to EPA to reasonably determine or predict effects 
from exposure to air, soil and water in communities near manufacturing, 
processing, industrial and non-industrial use facilities of the CPE 
Cluster chemicals. The petitioners state that in the absence of 
facility specific Toxic Release Inventory (TRI) data, other information 
sources should be used to identify relevant facilities to monitor near. 
EPA agrees with the petitioners that other sources of information, such 
as Chemical Data Reporting (CDR), can be used to identify relevant 
facilities on which exposure estimates could be made.
    Although the Problem Formulation and Initial Assessment states that 
chemical-specific environmental release data to air, soil and water 
from industrial sites could not be found (Ref. 2), EPA believes that 
approaches other than site-specific monitoring could be used to assess 
potential exposures from manufacturing, processing, industrial and non-
industrial uses. EPA believes it could be reasonable to estimate or 
model releases from facilities and concentrations in the surrounding 
environments using established EPA models such as ChemSTEER, E-FAST and 
AERMOD. ChemSTEER is a model to estimate workplace exposure and 
environmental releases (Ref. 126). E-FAST is a tool to estimate 
concentrations of chemicals released to air, water, landfills and 
consumer products (Ref. 127). AERMOD is a model to estimate chemical 
emissions from stationary industrial sources (Ref. 128). All of these 
models have been extensively reviewed and validated based on 
comparisons with monitoring data. These modeled estimates could be 
compared to existing U.S. monitoring data, which is not site-specific, 
and non-U.S. data associated with industrial facilities to assess the 
modeling approaches. Monitoring data exist for the CPE Cluster 
chemicals. As identified in the Problem Formulation Initial Assessment, 
there are over 100 available monitoring studies that could be used to 
characterize concentrations of the CPE Cluster chemicals in various 
media (Ref. 2).
    Air. The petition does not set forth facts demonstrating that there 
is insufficient information available to EPA to reasonably determine or 
predict effects from exposure through air in communities near 
manufacturing, processing, industrial and non-industrial use facilities 
of the CPE Cluster chemicals. Air sampling, using methods such as EPA 
Air Method Toxic Organics-9A (TO-9A, Determination of Polychlorinated, 
Polybrominated and Brominated/Chlorinated Dibenzo-p-Dioxins and 
Dibenzofurans in Ambient Air) (Ref. 129), in the vicinity of 
representative manufacturing and processing facilities, as requested by 
the petitioners may not be necessary. EPA could use existing 
approaches, such as modeling (ChemSTEER, E-FAST and AERMOD) (Refs. 126-
128) along with existing data to estimate releases and air 
concentrations near facilities for the CPE Cluster chemicals.
    The modeled data in combination with measurements of the CPE 
Cluster chemicals in ambient air as identified in the Problem 
Formulation and Initial Assessment for the U.S. and abroad (Refs. 40, 
49, 130 and 131), could be used to estimate air concentrations in 
communities near manufacturing and processing facilities. However, the 
petition does not address these possibilities, let alone explain why a 
testing order under section 4 would be necessary at this point. EPA 
considers this approach to be reasonable to determine exposure to 
communities near manufacturing and processing facilities, but may 
decide to pursue targeted sampling in the future near manufacturing and 
processing facilities to reduce uncertainty.
    Soil. The petition does not set forth facts demonstrating that 
there is insufficient information available to EPA to reasonably 
determine or predict effects from exposure through soil in communities 
near manufacturing, processing, industrial and non-industrial use 
facilities of the CPE Cluster chemicals. Soil sampling, using EPA 
methods, in the vicinity of representative manufacturing and processing 
facilities, as requested by the petitioners may not be necessary. 
Although the Problem Formulation and Initial Assessment stated that 
``Studies of soil with measured U.S. values are not readily available'' 
(Ref. 2 Page 67), EPA could use a combination of models (e.g. ChemSTEER 
and AERMOD) to predict deposition to soil near facilities in 
conjunction with predicted environmental releases to air. The modeled 
data in combination with measurements of the CPE Cluster chemicals in 
other media such as sludge, biosolids, and effluent as identified in 
the Problem Formulation and Initial Assessment (Refs. 40, 55, 122, 132 
and 133) could be used to estimate soil concentrations from land 
application of sludge and effluent. There is also a study in Germany, 
identified since the publication of the Problem Formulation and Initial 
Assessment, showing concentrations (ranging from approximately 2-20 
[mu]g/kg dry weight) of TCEP and TCPP in soil from grasslands and two 
urban sites (Ref. 134) which also could be evaluated for use in 
predicting soil concentrations in communities near manufacturing and 
processing facilities. However, the petition does not address these 
possibilities, let alone explain why a testing order under section 4 
would be necessary at this point. EPA considers this approach to be 
reasonable to determine exposure to communities near manufacturing and 
processing facilities, but may decide to pursue targeted sampling in 
the future near manufacturing and processing facilities to reduce 
uncertainty.
    Water. The petition does not set forth facts demonstrating that 
there is insufficient information available to EPA to reasonably 
determine or predict effects from exposure through water in communities 
near manufacturing, processing, and industrial and non-industrial use 
facilities of the CPE Cluster chemicals. Sampling studies, especially 
for various types of water (e.g., drinking water, surface water, and 
ground water) may not be necessary. EPA could use existing measured 
chemical-specific environmental data and modeling to estimate releases 
and water concentrations near facilities.
    For example, surface water concentrations near known facilities can 
be estimated using existing approaches, such as E-FAST and ChemSTEER 
along with estimated releases from these activities (Refs. 126 and 
127). As identified in the Problem Formulation and Initial Assessment, 
data are available for surface water concentrations of TCEP and TDCPP 
from USGS NWIS as well as other studies. Surface water monitoring data 
for TCPP are available in the open literature (Refs. 50, 55 and 135). 
Groundwater concentrations near known facilities can also be 
characterized using models such as E-

[[Page 17607]]

FAST and ChemSTEER (Refs. 126 and 127).
    Furthermore, groundwater data are available for TCEP and TDCPP from 
USGS NWIS in addition to other monitoring studies that have reported 
concentrations (generally ranging from non-detect to approximately 1 
[mu]g/L) for all three CPE Cluster chemicals (Refs. 65 and 136).
    As with surface and groundwater, drinking water concentrations near 
known facilities could also be estimated from releases using modeling 
(e.g., E-FAST and ChemSTEER). Furthermore, drinking water data from 
samples taken at drinking water treatment plants are available for 
TCPP, TCEP and TDCPP from several studies that have reported 
concentrations generally ranging from non-detect to approximately 1 
[mu]g/L (Refs. 14-16 and 137).
    In summary, EPA could use modeled data in combination with 
measurements of the CPE Cluster chemicals in water to estimate water 
concentrations in communities near manufacturing and processing 
facilities. However, the petition does not address these possibilities, 
let alone explain why a testing order under section 4 would be 
necessary at this point. EPA considers this approach to be reasonable 
to determine exposure to communities near manufacturing and processing 
facilities, but may decide to pursue targeted sampling in the future 
near manufacturing and processing facilities to reduce uncertainty.
    b and c. Workers (Industrial and Non-Industrial). The petition 
states that ``Occupational assessments, including biological and 
environmental monitoring, should be conducted in representative 
manufacturing, processing and industrial use facilities'' and that 
``Occupational assessments based on personal monitoring should be used 
for non-industrial workers'' (Ref. 1).
    Air Sampling. The petition does not set forth facts demonstrating 
that there is insufficient information available to EPA to reasonably 
determine or predict effects from exposure to the CPE Cluster chemicals 
through air for workers in manufacturing, processing, industrial and 
non-industrial use facilities. EPA believes that a combination of 
modeled data and existing data (e.g., non-U.S. data for similar 
activities/scenarios) could be used to determine or predict effects on 
workers exposed to air containing the CPE Cluster chemicals in an 
industrial and non-industrial environment.
    The CPE Problem Formulation and Initial Assessment document states 
that EPA's lack of toxicity data for inhalation and dermal routes of 
exposure as the basis for not further elaborating these exposure 
pathways. However, as described in Unit IV.C.1., EPA has described data 
and approaches that may be useful in filling these data gaps such that 
this may not be a critical data gap going forward. Additionally, the 
petitioners cited a report from the National Institute of Occupational 
Safety and Health (NIOSH) titled: ``Assessment of Occupational Exposure 
to Flame Retardants'' that aims to quantify and characterize 
occupational exposure routes (inhalation, ingestion, or dermal) for CPE 
Cluster chemicals as potentially useful for EPA to consider (Ref. 138). 
EPA agrees that this report appears to include a number of scenarios 
and measurements for which the petitioners are asking for testing and 
that EPA would consider any relevant information that results from this 
on-going study. However, the petition fails to explain how it 
considered worker exposure or why a testing order under section 4 would 
be necessary for additional information.
    If measured data are not available, it is still possible to assess 
exposure using modelling approaches. Specifically, EPA's ChemSTEER 
could be used to estimate worker exposure under a number of 
manufacturing, processing and use scenarios (Ref. 126). In addition, 
EPA may be able to use air concentration information or an estimation 
approach for a structurally similar chemical to estimate work exposures 
under specific industrial or non-industrial scenarios. However, the 
petition does not address these possibilities, let alone explain why a 
testing order under section 4 would be necessary at this point. EPA 
considers these approaches to be reasonable to determine exposure to 
workers of manufacturing and processing facilities, but may decide to 
pursue targeted sampling in the future for workers in manufacturing and 
processing facilities to reduce uncertainty.
    Dust Sampling. The petition does not set forth facts demonstrating 
that there is insufficient information available to EPA to reasonably 
determine or predict effects from exposure to the CPE Cluster chemicals 
through dust for workers in manufacturing, processing, industrial and 
non-industrial use facilities. EPA believes that a combination of 
modelling and existing data (e.g., non-U.S. data) could allow EPA to 
determine or predict effects on workers exposed to dust containing the 
CPE Cluster chemicals in an industrial and non-industrial environment.
    EPA believes the approaches described earlier, Unit IV.C.4.b. and 
c. regarding Air Sampling, are sufficient to characterize exposures to 
workers at manufacturing or processing facilities from exposure to 
dust. Sampling of settled dust (surface wipe and bulk sampling) using 
the OSHA Technical Manual (Ref. 139), as requested by the petitioners, 
may not be necessary. During Problem Formulation and Initial 
Assessment, EPA stated that inhalation and dermal exposure were the 
primary routes of occupational exposure for the CPE Cluster chemicals. 
Presence of the CPE Cluster chemicals in settled dust may indicate 
additional dermal and ingestion exposures are possible. However, 
surface wipe sampling does not provide a direct estimate of dermal or 
ingestion exposure. Surface wipe sampling would need to be combined 
with information on transfer efficiency between the surface, hands, and 
objects as well as the number of events to estimate exposures from 
ingestion (Ref. 140).
    EPA notes that in the ongoing NIOSH study (Ref. 138) surface wipe 
sampling is not included, which provides support for the conclusion 
that settled dust is not a customary measure for occupational exposure. 
Furthermore, EPA would use any information generated from the NIOSH 
study considered relevant for this exposure pathway.
    Biomonitoring. EPA believes the approaches described previously are 
sufficient to characterize exposures to workers at manufacturing or 
processing facilities from external doses/concentrations. The 
biomonitoring data collected following the protocols of the ongoing 
NIOSH study or other peer-reviewed studies, as requested by the 
petitioners, is not needed. EPA would, however, consider any data or 
information generated from the NIOSH study deemed to be relevant and 
applicable for discerning exposures from all exposure routes. 5. 
Exposures from recycling. The petition does not set forth facts 
demonstrating that there is insufficient information available to EPA 
to reasonably determine or predict effects to communities and workers 
specifically located at or near facilities that recycle the CPE Cluster 
chemical-containing products. EPA believes that the approaches 
requested by the petitioners to measure exposure to the CPE Cluster 
chemicals from recycling facilities may not be needed. These are the 
same approaches referenced in Unit IV.C.4.a.b. and c. EPA did not 
include in the Problem Formulation and Initial Assessment a search for 
data associated with the recycling of the CPE Cluster chemicals. Going 
forward, EPA would initiate a comprehensive search of

[[Page 17608]]

available data. EPA could then assess the nature of the data, including 
those cited by the petitioners (Refs. 141-143) to determine feasibility 
of conducting an assessment. For example, the following could inform 
development of exposure scenarios for recycling facilities within the 
United States:
    a. The number and location of recycling facilities in the United 
States;
    b. The types and volumes of products that are accepted by these 
sites; and
    c. the recycling and disposal methods employed at these facilities.
    With such information, the recycling processes used in the U.S. 
could potentially be assessed. However, the petition does not address 
this possibility, let alone explain why a testing order under section 4 
would be necessary on this point.
    EPA also notes that the NIOSH study (Ref. 138) may inform 
occupational exposures from recycling facilities and could be 
considered in an occupational assessment of CPE Cluster chemicals. EPA 
also notes that the settled dust sampling and biomonitoring data, as 
requested by the petitioners, may not be the most appropriate data to 
collect for the reasons provided previously in Unit IV.C.4.b. and c. 
EPA would consider any data or information generated from the NIOSH 
study deemed to be relevant and applicable for discerning exposures 
from all exposure routes. 6. Exposure from disposal. The petition does 
not set forth facts demonstrating that there is insufficient 
information available to EPA to reasonably determine or predict effects 
to communities and workers specifically located at or near facilities 
that dispose of CPE Cluster chemical-containing products. EPA believes 
that the approaches requested by the petitioners to measure exposure to 
the CPE Cluster chemicals from disposal facilities may not be needed. 
These are the same approaches referenced in Unit IV.C.4.a.b. and c. EPA 
did not include in the Problem Formulation and Initial Assessment a 
search for data associated with the disposal of the CPE Cluster 
chemicals. Going forward, EPA would initiate a comprehensive search of 
available data. EPA could then assess the nature of the data to 
determine feasibility of conducting an assessment. For example, the 
following could inform development of exposure scenarios for recycling 
facilities within the United States:
    a. The number and location of recycling facilities in the United 
States;
    b. The types and volumes of products that are accepted by these 
sites; and
    c. The recycling and disposal methods employed at these facilities.
    With such data or information, the recycling processes used in the 
U.S. could potentially be assessed. However, the petition does not 
address this possibility, let alone explain why a testing order under 
section 4 would be necessary at this point.
    EPA also notes that the NIOSH study (Ref. 138), may inform 
occupational exposures from disposal facilities and could be considered 
in an occupational assessment of the CPE Cluster chemicals. EPA also 
notes that the settled dust sampling and biomonitoring data, as 
requested by the petitioners, may not be the most appropriate data to 
collect for the reasons provided previously in Unit IV.C.4.b. and c., 
but that EPA would consider any data or information generated from the 
NIOSH study deemed to be relevant and applicable for discerning 
exposures from any/all exposure routes. 7. Exposures of birds, wildlife 
and sediment organisms.
    Terrestrial organism toxicity. The petition does not set forth 
facts demonstrating that there is insufficient information available to 
EPA to reasonably determine or predict CPE Cluster chemicals' effects 
to terrestrial organisms. The avian toxicity test (OCSPP 850.2100: 
Avian Acute Oral Toxicity Test) (Ref. 144) as requested by the 
petitioners is not necessary. Although the Problem Formulation and 
Initial Assessment previously stated that there was limited ability to 
quantify risks because of a lack of monitoring data and hazard 
endpoints (Ref. 2), studies have been identified since the publication 
of the Problem Formulation and Initial Assessment document including a 
study by Fernie et al. (2013) measuring toxicity of all three CPE 
Cluster chemicals to American Kestrels (Ref. 145) using a modified 
Avian Dietary Toxicity Test (OCSPP 850.2200) (Ref. 146), and a study on 
the toxicity of TCEP to hens (Ref. 147).
    EPA considers the three chemicals in the CPE Cluster to have 
similar hazard profiles from an ecological perspective and hence, read-
across, in which data for one structurally similar chemical can be used 
to assess the toxicity of another, could be appropriately applied. 
EPA's conclusion regarding this approach is supported by its use in 
risk assessments performed by the European Union (Refs. 96, 97 and 
148). Collectively, the available data could be used to determine or 
predict the effects of the CPE Cluster chemicals on terrestrial 
organism, specifically birds, from repeated exposures.
    Furthermore, EPA's use of available existing toxicity information 
reduces the use of vertebrate animals in the testing of chemical 
substances in a manner consistent with provisions described in TSCA 
section 4(h).
    Soil/Sediment dwelling organisms. The petition does not set forth 
facts demonstrating that there is insufficient information available to 
EPA to reasonably determine or predict the CPE Cluster chemicals' 
effects to soil/sediment dwelling organisms. The Earthworm Subchronic 
Toxicity Test (OCSPP 850.3100) (Ref. 152) as requested by petitioners 
is not needed. Although the Problem Formulation and Initial Assessment 
states that data was not available to characterize risk for sediment 
dwelling organisms (Ref. 2), adequate sediment toxicity studies exist 
for TDCPP and this data could also be used to evaluate and characterize 
the effects of the other CPE Cluster chemicals to sediment dwelling 
organisms using read-across. There are chronic toxicity studies on 
three sediment-dwelling species, Chironomus riparius (midge), Hyallela 
Azteca (amphipod) and Lumbriculus variegatus (oligochaete) (Refs. 150-
152). Since publication of the Problem Formulation and Initial 
Assessment, EPA identified additional data on soil/sediment dwelling 
organisms that could be used to assess risks to these organisms (Refs. 
153-155).
    EPA considers the three chemicals in the CPE Cluster to have 
similar hazard profiles from an ecological perspective and hence, read-
across, in which data for one structurally similar chemical can be used 
to assess the toxicity of another, could be appropriately applied. 
EPA's conclusion regarding this approach is supported by its use in 
risk assessments performed by the European Union (Refs. 96, 97, and 
148). Collectively, the available data could be used to determine or 
predict the effects of the CPE Cluster chemicals on soil/sediment 
dwelling organisms.
    Plant toxicity. The petition does not set forth facts demonstrating 
that there is insufficient information available to EPA to reasonably 
determine or predict the CPE Cluster chemicals effects on plants. The 
Early Seedling Growth Toxicity Test (OCSPP 850.4230) (Ref. 156) as 
requested by the petitioners is not needed. Since publication of the 
Problem Formulation and Initial Assessment document, EPA identified 
data on the toxicity to terrestrial plants from TDCPP (Ref. 157), TCEP 
(Ref. 158) and TCPP (Ref. 159). The data could be used to determine or 
predict the effects of the CPE Cluster chemicals on plants.
    8. EPA's conclusions. EPA denied the request to issue an order 
under TSCA section 4 because the TSCA section 21 petition does not set 
forth sufficient

[[Page 17609]]

facts for EPA to find that the information currently available to the 
Agency, including existing studies (identified prior to or after 
publication of EPA's Problem Formulation and Initial Assessment) on the 
CPE Cluster chemicals as well as alternate approaches for risk 
evaluation is insufficient to permit a reasoned determination or 
prediction of the health or environmental effects of the CPE Cluster 
chemicals at issue in the petition nor that the specific testing the 
petition identified is necessary to develop additional information, as 
elaborated throughout Unit IV. of this notice.
    Furthermore, to the extent the petitioners request vertebrate 
testing, EPA emphasizes that future petitions should discuss why such 
testing is appropriate, considering the reduction of testing on 
vertebrates encouraged by TSCA section 4(h), as amended.

V. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. Earthjustice, Natural Resources Defense Council, Toxic-Free 
Future, Safer Chemicals, Healthy Families, BlueGreen Alliance, 
Environmental Health Strategy Center; Eve Gartner, Earthjustice; and 
Veena Singla, Natural Resources Defense Council to Gina McCarthy, 
Administrator, Environmental Protection Agency. Re: Petition to 
Order Testing of the Chlorinated Phosphate Ester Cluster Flame 
Retardants (TCEP, TCPP and TDCPP) under Section 4(a) of the Toxic 
Substances Control Act. January 6, 2017.
2. EPA. 2015a. TSCA Work Plan Chemical Problem Formulation and 
Initial Assessment Chlorinated Phosphate Ester Cluster Flame 
Retardants.
3. NTP (National Toxicology Program). 1991a.Toxicology and 
Carcinogenesis Studies of Tris(2-Chloroethyl) Phosphate (CAS No. 
115-96-8) in F344/N Rats and B6c3f1 Mice (Gavage Studies). 
Department of Health and Human Services. Research Triangle Park, NC. 
NTP Technical Report 391.
4. Freudenthal, R.I., and R.T. Henrich. 2000. Chronic Toxicity and 
Carcinogenic Potential of Tris(1,3-Dichloro-2-Propyl) Phosphate in 
Sprague-Dawley Rat. International Journal of Toxicology. 19, 119-
125.
5. Freudenthal, R.I., and R.T. Henrich. 1999. A Subchronic Toxicity 
Study of Fyrol Pcf in Sprague-Dawley Rats. International Journal of 
Toxicology, 18(3), 173-176.
6. Tilson, H., B. Veronesi, R. McLamb, and H. Matthews. 1990. Acute 
Exposure to Tris(2-Chloroethyl) Phosphate Produces Hippocampal 
Neuronal Loss and Impairs Learning in Rats. Toxicology and Applied 
Pharmacology, 106(2), 254-269.
7. Anonymous. 1977. Health and safety data for 4 chemicals with 
cover letter dated 021089 (sanitized). Submitted to the U.S. 
Environmental Protection Agency under TSCA Section 8D. EPA86-
8900001189. OTS0516689.
8. EPA. 2015b. Flame Retardants Used in Flexible Polyurethane Foam: 
An Alternatives Assessment Update. Doc. No. 744-R-15-002. https://www.epa.gov/sites/production/files/2015-08/documents/ffr_final.pdf.
9. Cal. EPA, Office of Environmental Health Hazard Assessment 
(OEHHA). Oct. 21, 2016. Chemicals Known to the State to Cause Cancer 
or Reproductive Toxicity 21 https://oehha.ca.gov/media/downloads/proposition-65//p65single10212016.pdf.
10. OEHHA. July 2011. Reproductive and Cancer Hazard Assessment 
Branch, Evidence on the Carcinogenicity of Tris(1,3-Dichloro-2-
Propyl) Phosphate. https://oehha.ca.gov/media/downloads/proposition-65/chemicals/tdcpp070811.pdf.
11. OEHHA. Oct. 21, 2016. Chemicals Known to the State to Cause 
Cancer or Reproductive Toxicity. https://oehha.ca.gov/media/downloads/proposition-65//p65single10212016.pdf.
12. European Chemicals Agency. Nov. 27, 2009. Support Document for 
Identification of Tris(2-Chloroethyl) Phosphate as a Substance of 
Very High Concern Because of its CMR Properties. https://echa.europa.eu/documents/10162/6d09755f-7fcb-4a00-b7ce-91ab45a2e5af.
13. See Cal SAFER. Candidate Chemical Details (last visited Jan. 4, 
2017), https://calsafer.dtsc.ca.gov/chemical/ChemicalDetail.aspx?chemid=20838.
14. Benotti, M., R. Trenholm, B. Vanderford, J. Holady, B. Stanford, 
and S. Snyder. 2009. Pharmaceuticals and Endocrine Disrupting 
Compounds in U.S. Drinking Water. Environmental Science & 
Technology, 43(3), 597-603.
15. Snyder, S.A., E.C. Wert, H. Lei, P. Westerhoff, and Y. Yoon. 
2007. Removal of Edcs and Pharmaceuticals in Drinking and Reuse 
Treatment Processes.
16. Stackelberg, P.E., J. Gibs, E.T. Furlong, M.T. Meyer, S.D. 
Zaugg, and R.L. Lippincott. 2007. Efficiency of Conventional 
Drinking-Water-Treatment Processes in Removal of Pharmaceuticals and 
Other Organic Compounds. Science of The Total Environment, 377(2-3), 
255-272.
17. Fang, M., T. Webster, D. Gooden, E. Cooper, M. McClean, C. 
Carignan, C. Makey, and H. Stapleton. 2013. Investigating a Novel 
Flame Retardant Known as V6: Measurements in Baby Products, House 
Dust, and Car Dust. Environmental Science & Technology, 47(9), 4449-
4454.
18. Stapleton, H.M., S. Klosterhaus, A.S. Keller, P.L. Ferguson, S. 
van Bergen, E.M. Cooper, T.F. Webster, and A. Blum. 2011. 
Identification of Flame Retardants in Polyurethane Foam Collected 
from Baby Products. Environmental Science & Technology, 45(12), 
5323-5331.
19. Stapleton, H.M., S. Klosterhaus, S. Eagle, J. Fuh, J.D. Meeker, 
A. Blum, and T.F. Webster. 2009. Detection of Organophosphate Flame 
Retardants in Furniture Foam and U.S. House Dust. Environmental 
Science & Technology, 43(19), 7490-7495.
20. Stapleton, H.M., S. Sharma, G. Getzinger, P.L. Ferguson, M. 
Gabriel, T.F. Webster, and A. Blum. 2012. Novel and High Volume Use 
Flame Retardants in U.S. Couches Reflective of the 2005 Pentabde 
Phase Out. Environmental Science & Technologynol, 46(24), 13432-
13439.
21. Keller, A.S., N.P. Raju, T.F. Webster, and H.M. Stapleton. 2014. 
Flame Retardant Applications in Camping Tents and Potential 
Exposure. Environmental Science and Technology Letters(1), 152-155.
22. Ali, N., A.C. Dirtu, N. Van den Eede, E. Goosey, S. Harrad, H. 
Neels, A. Mannetje, J. Coakley, J. Douwes, and A. Covaci. 2012. 
Occurrence of Alternative Flame Retardants in Indoor Dust from New 
Zealand: Indoor Sources and Human Exposure Assessment. Chemosphere, 
88(11), 1276-1282.
23. Ali, N., N. Van den Eede, A.C. Dirtu, H. Neels, and A. Covaci. 
2012. Assessment of Human Exposure to Indoor Organic Contaminants 
Via Dust Ingestion in Pakistan. Indoor Air, 22(3), 200-211.
24. Allen, J.G., H.M. Stapleton, J. Vallarino, E. McNeely, M.D. 
McClean, S.J. Harrad, C.B. Rauert, and J.D. Spengler. 2013. Exposure 
to Flame Retardant Chemicals on Commercial Airplanes. Environmental 
Health, 12(17), 13.
25. Bergh, C., R. Torgrip, G. Emenius, and C. Ostman. 2011. 
Organophosphate and Phthalate Esters in Air and Settled Dust--a 
Multi-Location Indoor Study. Indoor Air, 21, 67-76.
26. Brommer, S., S. Harrad, N. Van den Eede, and A. Covaci. 2012. 
Concentrations of Organophosphate Esters and Brominated Flame 
Retardants in German Indoor Dust Samples. Journal of Environmental 
Monitoring, 14(9), 2482-2487.
27. Carignan, C.C., M.D. McClean, E.M. Cooper, D.J. Watkins, A.J. 
Fraser, W. Heiger-Bernays, H.M. Stapleton, and T.F. Webster. 2013. 
Predictors of Tris(1,3-Dichloro-2-Propyl) Phosphate Metabolite in 
the Urine of Office Workers. Environment International, 55, 56-61.
28. Dodson, R.E., L.J. Perovich, A. Covaci, N. Van den Eede, A.C. 
Ionas, A.C. Dirtu, J.G. Brody, and R.A. Rudel. 2012. After the Pbde 
Phase-Out: A Broad Suite of Flame Retardants in Repeat House Dust 
Samples from California. Environmental Science and Technology, 
46(24), 13056-13066.
29. Marklund, A., B. Andersson, and P. Haglund. 2003. Screening of

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Organophosphorus Compounds and Their Distribution in Various Indoor 
Environments. Chemosphere, 53(9), 1137-1146.
30. Meeker, J.D., and H.M. Stapleton. 2010. House Dust 
Concentrations of Organophosphate Flame Retardants in Relation to 
Hormone Levels and Semen Quality Parameters. Environmental Health 
Perspectives, 118(3), 318-323.
31. Takigami, H., G. Suzuki, Y. Hirai, Y. Ishikawa, M. Sunami, and 
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List of Subjects in 40 CFR Chapter I

    Environmental protection, Flame retardants, Hazardous substances, 
chlorinated phosphate ester cluster.

    Dated: April 6, 2017.
Wendy Cleland-Hamnett, Acting,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2017-07404 Filed 4-11-17; 8:45 am]
BILLING CODE 6560-50-P