[Federal Register Volume 82, Number 69 (Wednesday, April 12, 2017)]
[Proposed Rules]
[Pages 17601-17613]
[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:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
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
http://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 http://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

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

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

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

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).

    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-

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

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

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 http://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. http://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. http://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

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
S. Sakai. 2009. Flame Retardants in Indoor Dust and Air of a Hotel
in Japan. Environment International, 35(4), 688-693.
32. Cao, S., X. Zeng, H. Song, H. Li, Z. Yu, G. Sheng, and J. Fu.
2012. Levels and Distributions of Organophosphate Flame Retardants
and Plasticizers in Sediment from Taihu Lake, China. Environmental
Toxicology and Chemistry, 31(7), 1478-1484.
33. Stapleton, H.M., J. Misenheimer, H.K., and T.F. Webster. 2014.
Flame Retardant Associations between Children's Handwipes and House
Dust. Chemosphere, 116, 54-60.
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021). Washington State Department of Ecology: Olympia, WA. https://fortress.wa.gov/ecy/publications/documents/1404021.pdf.
143. Miller, G.Z. & Gearhart, J. 2016. Traveling with Toxics: Flame
Retardants & Other Chemicals in Children's Car Seats. Ecology
Center: Ann Arbor, MI. http://www.ecocenter.org/healthy-stuff/pages/childrens-car-seat-study-2016-report.
144. EPA. 2012a. Avian Acute Oral Toxicity Test (OCSPP Test
Guideline 850.2100).
145. Fernie K., Palace V., Peters L., Basu Nil, Letcher R., Karouna-
Renier N., Schultz S., Lazarus R. and Rattner B. 2015. Investigating
Endocrine and Physiological Parameters of Captive American Kestrels
Exposed by Diet to Selected Organophosphate Flame Retardants;
Environmental Science & Technology, vol. 49, issue 12, pp. 7448-
7455.
146. EPA. 2012b. Avian Dietary Toxicity Test (OCSPP Test Guideline
850.2200).
147. Sprague G.L., Sandvik L.L., Brookins-Hendricks M.J. and
Bickford A.A. 1981. Neurotoxicity of two organophosphorus ester
flame retardants in hens. J. Toxicol. Environ. Health, 8, 507-518.
148. EU (European Union). 2009. European Union Risk Assessment
Report: Tris (2-Chloroethyl) Phosphate, (TCEP) CAS No: 115-96-8.
Ireland and United Kingdom, Luxembourg. http://echa.europa.eu/documents/10162/6434698/orats_final_rar_tris2-chloroethylphosphate_en.pdf.
149. EPA. 2012c. Earthworm Subchronic Toxicity Test (OCSPP Test
Guideline 850.3100).
150. Wildlife International, Ltd. 2006a. Tris[2-chloro-1-
(chloromethyl)ethyl]-phosphate (TDCP): A 28-Day Sediment Toxicity
Test with Chironomus riparius Using Spiked Sediment. Final Report
Project Number: 583A-104. Wildlife International, Ltd., Easton,
Maryland 21601, U.S.A., as cited in EU (European Union), 2008b. (REF
106)
151. Wildlife International, Ltd. 2006b. Tris[2-chloro-1-
(chloromethyl)ethyl]-phosphate (TDCP): A Prolonged Sediment Toxicity
Test with Hyalella azteca Using Spiked Sediment. Final Report
Project Number: 583A-105. Wildlife International, Ltd., Easton,
Maryland 21601, U.S.A., as cited in EU (European Union), 2008b.
(Ref. 97)
152. Wildlife International, Ltd. 2006c. Tris[2-chloro-1-
(chloromethyl)ethyl]-phosphate (TDCP): A Prolonged Sediment Toxicity
Test with Lumbriculus variegatus using Spiked Sediment. Final Report
Project Number: 583A-106. Wildlife International, Ltd., Easton,
Maryland 21601, U.S.A., as cited in EU (European Union), 2008b.
(Ref. 97)
153. Wetton P.M. 1996. Acute toxicity to earthworms. Report of SPL
Project Number: 071/458. SafePharm Laboratories Ltd., Derby. as
cited in EU (European Union), 2008a (Ref. 96) and EU (European
Union), 2008b (Ref. 97).
154. Servajean E. 2003a. Laboratory determination of the long-term
toxicity of TCPP to earthworms (Eisenia fetida) using artificial
soil substrate. Report of Phytosafe Study Number: 03-69-005-ES.
PHYTOSAFE s.a.r.l., 2, rue Marx Dormoy, 64000 Pau, France. as cited
in EU (European Union), 2008a (Ref. 96).
155. Van Ginkel C.G. 2005b. Toxicity of TDCP to soil micro-
organisms: Nitrogen transformation inhibition test. Akzo Nobel
Research and Technology Chemicals Arnhem. Report number CER F05047 T
05015 NTI, 20th October 2005. as cited in EU (European Union), 2008b
(Ref. 97).
156. EPA. 2012d. Early Seedling Growth Toxicity Test (OCSPP Test
Guideline 850.4230).
157. Servajean E. 2004b. Laboratory assessment of the side-effects
of TDCP on plant growth. Study Number: 04-99-022-ES. PHYTOSAFE
s.a.r.l. Pau, France. as cited in EU (European Union), 2008b (Ref.
97).
158. R[ouml]mbke, J. Bauer, C. Brodesser, J. Brodsky, J. Danneberg,
G. Heimann, D. Renner, I. and Schallnass, H.J. 1995. Basis for the
assessment of the ecotoxicological potential of ``existing
chemicals'' in the terrestrial environment--development of a testing
strategy. Batelle Eur. Res. rept. 106 04 103 (UBA), UBA-Texte 53/95
(in German), as cited in EU (European Union), 2009 (Ref. 148).
159. Servajean E. 2003b. Laboratory assessment of the side-effects
of TCPP on plant growth. Report of Phytosafe Study Number: 03-69-
012-ES. PHYTOSAFE s.a.r.l., 2, rue Marx Dormoy, 64000 Pau, France.
as cited in EU (European Union), 2008a (Ref. 96).

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]
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[Federal Register Volume 88, Number 63 (Monday, April 3, 2023)]
[Notices]
[Pages 19708-19709]
[FR Doc No: 2023-06805]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Availability of the Draft Programmatic Environmental
Assessment (PEA) for FAA-Recognized Identification Areas (FRIAs)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of availability; request for comments.

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SUMMARY: The Federal Aviation Administration (FAA) announces that the
Draft Programmatic Environmental Assessment (PEA) for FAA-Recognized
Identification Areas (FRIAs) is available for public review and
comment.

DATES: Send comments on or before May 3, 2023.

FOR FURTHER INFORMATION CONTACT: For questions concerning this action,
contact Mike Millard, Aviation Safety Inspector/Environmental
Specialist, Flight Standards, General Aviation Operations Branch, AFS-
830; telephone 1-844-359-6981; email [email protected].

ADDRESSES: Send comments with the subject line, ``Public Comment on
Draft FRIA PEA'' on all submitted correspondence using the following
method. Email comments to [email protected].
    Privacy: The FAA will post all comments it receives, without
change, including any personal information the commenter provides, to
the Final PEA, along with the FAA's response to those comments. For
additional information, the applicable system of records notice (SORN),
DOT/ALL-14, 73 FR 3316 (Jan. 17, 2008), can be reviewed at https://www.govinfo.gov/content/pkg/FR-2008-01-17/pdf/E8-785.pdf.

SUPPLEMENTARY INFORMATION:

I. Background

    The Draft PEA analyzes and discloses the potential environmental
impacts associated with the establishment of FRIAs, pursuant to the
National Environmental Policy Act. FRIAs may be established in
accordance with 14 CFR part 89. A FRIA is a defined geographic area
where unmanned aircraft can be flown without remote identification
equipment. Both the unmanned aircraft and the pilot must be located
within the FRIA's boundaries throughout the operation. In addition, the
pilot of the unmanned aircraft must be able to see it at all times
throughout the duration of the flight. Only FAA-recognized Community
Based Organizations and educational institutions such as primary and
secondary schools, trade schools, colleges, and universities are
eligible to request the establishment of a FRIA. If the FAA approves
the establishment of a FRIA, the approval will be valid for 48 calendar
months.
    The environmental impacts of approving these limited, location-
specific areas for the operations of unmanned aircraft have been
considered in a manner consistent with the provisions of the National
Environmental Policy Act (NEPA), as amended (42 U.S.C. 4321-4347), the
regulations of the Council on Environmental Quality (40 CFR parts 1500-
1508), and FAA Order 1050.1F, Environmental Impacts: Policies and
Procedures.
    A Draft PEA has been prepared and, based on this analysis, the FAA
has preliminarily determined there will not be a significant impact to
the human environment. As a result, an Environmental Impact Statement
(EIS) has not been initiated (40 CFR 1501.6). The FAA intends for this
PEA to create efficiencies by establishing a framework that can be used
for ``tiering,'' where appropriate, to project-specific actions that
require additional analysis. As decisions on specific applications are
made, to the extent additional NEPA analysis is required, environmental
review will be conducted to supplement the analysis set forth in this
PEA.
    The Draft PEA is available for review online at the following link:
https://www.faa.gov/uas/advanced_operations/nepa_and_drones.

Comments Invited

    The FAA invites interested stakeholders to submit comments on the
Draft PEA, as specified in the ADDRESSES section of this Notice.
Commenters should include the subject line, ``Public Comment on Draft
FRIA PEA'' on all comments submitted to the FAA. All comments must be
provided in English.
    The FAA will accept comments in Word, PDF, or email body. No
business proprietary information, copyrighted information, or
personally identifiable

information should be submitted in response to this request. Please be
aware that comments submitted may be posted on a Federal website or
otherwise released publicly.
    The most helpful comments reference a specific recommendation,
explain the reason for any recommended change, and include supporting
information. The FAA will consider all comments received on or before
the closing date. The FAA will also consider late filed comments if it
is possible to do so without incurring expense or delay.

    Issued in Washington, DC.
David M. Menzimer,
Manager, General Aviation Operations Branch, General Aviation and
Commercial Division, Office of Safety Standards, Flight Standards
Service.
[FR Doc. 2023-06805 Filed 3-31-23; 8:45 am]
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