82_FR_17670 82 FR 17601 - Chlorinated Phosphate Ester (CPE) Cluster; TSCA Section 21 Petition; Reasons for Agency Response

82 FR 17601 - Chlorinated Phosphate Ester (CPE) Cluster; TSCA Section 21 Petition; Reasons for Agency Response

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 69 (April 12, 2017)

Page Range17601-17613
FR Document2017-07404

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.

Federal Register, Volume 82 Issue 69 (Wednesday, April 12, 2017)
[Federal Register Volume 82, Number 69 (Wednesday, April 12, 2017)]
[Proposed Rules]
[Pages 17601-17613]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07404]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

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

[[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 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

[[Page 17610]]

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.
34. 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.
35. Bjorklund, J., S. Isetun, and U. Nilsson. 2004. Selective 
Determination of Organophosphate Flame Retardants and Plasticizers 
in Indoor Air by Gas Chromatography, Positive-Ion Chemical 
Ionization and Collision-Induced Dissociation Mass Spectrometry. 
Rapid Communications in Mass Spectrometry, 18(24), 3079-3083.
36. Green, N., M. Schlabach, T. Bakke, E. Brevik, C. Dye, D. Herzke, 
S. Huber, B. Plosz, M. Remberger, M. Schoyen, H. Uggerud, and C. 
Vogelsang. 2008. Screening of Selected Metals and New Organic 
Contaminants, 2007. 5569-2008. Norwegian Pollution Contral Agency, 
Oslo, Norway.
37. Hartmann, P.C., D. Burgi, and W. Giger. 2004. Organophosphate 
Flame Retardants and Plasticizers in Indoor Air. Chemosphere, 57(8), 
781-787.
38. Ingerowski, G., A. Friedle, and J. Thumulla. 2001. Chlorinated 
Ethyl and Isopropyl Phosphoricacid Triesters in the Indoor 
Environment--an Inter-Laboratory Exposure Study. Indoor Air, 11, 
145-49.
39. Makinen, M.S.E., M.R.A. Makinen, J.T.B. Koistinen, A.L. Pasanen, 
P.O. Pasanen, P.J. Kalliokoski, and A.M. Korpi. 2009. Respiratory 
and Dermal Exposure to Organophosphorus Flame Retardants and 
Tetrabromobisphenol a at Five Work Environments. Environmental 
Science & Technology, 43(3), 941-947.
40. Marklund, A., B. Andersson, and P. Haglund. 2005. Traffic as a 
Source of Organophosphorus Flame Retardants and Plasticizers in 
Snow. Environmental Science & Technology, 39(10), 3555-3562.
41. Sanchez, C., M. Ericsson, H. Carlsson, and A. Colmsjo. 2003. 
Determination of Organophosphate Esters in Air Samples by Dynamic 
Sonication-Assisted Solvent Extraction Coupled on-Line with Large-
Volume Injection Gas Chromatography Utilizing a Programmed-
Temperature Vaporizer. Journal of Chromatography A, 993(1-2), 103-
110.
42. Staaf, T., and C. Ostman. 2005a. Indoor Air Sampling of 
Organophosphate Triesters Using Solid Phase Extraction (Spe) 
Adsorbents. Journal of Environmental Monitoring (JEM), 7(4), 344-
348.
43. Staaf, T., and C. Ostman. 2005b. Organophosphate Triesters in 
Indoor Environments. Journal of Environmental Monitoring (JEM), 
7(9), 883-887.
44. Tollback, J., D. Tamburro, C. Crescenzi, and H. Carlsson. 2006. 
Air Sampling with Empore Solid Phase Extraction Membranes and Online 
Single-Channel Desorption/Liquid Chromatography/Mass Spectrometry 
Analysis: Determination of Volatile and Semi-Volatile 
Organophosphate Esters. Journal of Chromatography. A, 1129(1), 1-8.
45. Kanazawa, A., I. Saito, A. Araki, M. Takeda, M. Ma, Y. Saijo, 
and R. Kishi. 2010. Association between Indoor Exposure to Semi-
Volatile Organic Compounds and Building-Related Symptoms among the 
Occupants of Residential Dwellings. Indoor Air, 20(1), 72-84.
46. Ohura, T., T. Amagai, Y. Senga, and M. Fusaya. 2006. Organic Air 
Pollutants Inside and Outside Residences in Shimizu, Japan: Levels, 
Sources and Risks. Science of The Total Environment, 366(2-3), 485-
499.
47. Otake, T., J. Yoshinaga, and Y. Yanagisawa. 2004. Exposure to 
Phthalate Esters from Indoor Environment. Journal of Exposure 
Analysis and Environmental Epidemiology, 14, 524-528.
48. Otake, T., J. Yoshinaga, and Y. Yukio Yanagisawa. 2001. Analysis 
of Organic Esters of Plasticizer in Indoor Air by GC-Ms and GC-Fpd. 
Environmental Science & Technology, 35, 3099-3102.
49. Saito, I., A. Onuki, and H. Seto. 2007. Indoor Organophosphate 
and Polybrominated Flame Retardants in Tokyo. Indoor Air, 17(1), 28-
36.
50. Alvarez, D., K. Maruya, N. Dodder, W. Lao, E. Furlong, and K. 
Smalling. 2013. Occurrence of Contaminants of Emerging Concern Along 
the California Coast (2009-10) Using Passive Sampling Devices. 
Marine Pollution Bulletin, 81(2), 347-354.
51. Hoppe-Jones, C., G. Oldham, and J.E. Drewes. 2010. Attenuation 
of Total Organic Carbon and Unregulated Trace Organic Chemicals in 
U.S. Riverbank Filtration Systems. Water Research, 44(15), 4643-
4659.
52. Kolpin, D.W., E.T. Furlong, M.T. Meyer, E.M. Thurman, S.D. 
Zaugg, L.B. Barber, and H.T. Buxton. 2002. Pharmaceuticals, 
Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 
1999-2000: A National Reconnaissance. Environmental Science & 
Technology, 36(6), 1202-1211.
53. Oros, D.R., W.M. Jarman, T. Lowe, N. David, S. Lowe, and J.A. 
Davis. 2003. Surveillance for Previously Unmonitored Organic 
Contaminants in the San Francisco Estuary. Marine Pollution 
Bulletin, 46(9), 1102-1110.
54. Vanderford, B.J., R.A. Pearson, D.J. Rexing, and S.A. Snyder. 
2003. Analysis of Endocrine Disruptors, Pharmaceuticals, and 
Personal Care Products in Water Using Liquid Chromatography/Tandem 
Mass Spectrometry. Analytical Chemistry, 75(22), 6265-6274.
55. Vidal-Dorsch, D.E., S.M. Bay, K. Maruya, S.A. Snyder, R.A. 
Trenholm, and B.J. Vanderford. 2012. Contaminants of Emerging 
Concern in Municipal Wastewater Effluents and Marine Receiving 
Water. Environmental Toxicology and Chemistry, 31(12), 2674-2682.
56. Andresen, J., and K. Bester. 2006. Elimination of 
Organophosphate Ester Flame Retardants and Plasticizers in Drinking 
Water Purification. Water Research, 40(3), 621-629.
57. Andresen, J., A. Grundmann, and K. Bester. 2004. 
Organophosphorus Flame Retardants and Plasticisers in Surface 
Waters. Science of The Total Environment, 332(1-3), 155-166.
58. Andresen, J., D. Muir, D. Ueno, C. Darling, N. Theobald, and K. 
Bester. 2007. Emerging Pollutants in the North Sea in Comparison to 
Lake Ontario, Canada, Data. Environmental Toxicology and Chemistry, 
26(6), 1081-1089.
59. Bacaloni, A., F. Cucci, C. Guarino, M. Nazzari, R. Samperi, and 
A. Lagana. 2008. Occurrence of Organophosphorus Flame Retardant and 
Plasticizers in Three Volcanic Lakes of Central Italy. Environmental 
Science and Technology, 42(6), 1898-1903.
60. Bendz, D., N.A. Paxeus, T.R. Ginn, and F.J. JLoge. 2005. 
Occurrence and Fate of Pharmaceutically Active Compounds in the 
Environment, a Case Study: H[uuml]Oje River in Sweden. Journal of 
Hazardous Materials, 122, 195-204.
61. Bollmann, U., A. Moeler, Z. Xie, R. Ebinghaus, and J. Einax. 
2012. Occurrence and Fate of Organophosphorus Flame Retardants and 
Plasticizers in Coastal and Marine Surface Waters. Water Research, 
46(2), 531-538.
62. Clara, M., M. Kralik, H. Miesbauer, M. Schabuss, S. Scharf, B. 
Vallant, S. Weiss, and B. Grillitsch (Environment Agency Austria). 
2010. Pollutants of Priority Concern in Austrian Rivers Mercury and 
Its Compounds Trisphosphates. REP-0253. Vienna, Austria.
63. Cristale, J., A. Katsoyiannis, C. Chen, K.C. Jones, and S. 
Lacorte. 2013a. Assessment of Flame Retardants in River Water Using 
a Ceramic Dosimeter Passive Sampler. Environmental Pollution, 172, 
163-169.
64. Cristale, J., A. Katsoyiannis, A.J. Sweetman, K.C. Jones, and S. 
Lacorte. 2013b. Occurrence and Risk Assessment of Organophosphorus 
and Brominated Flame Retardants in the River Aire (Uk). 
Environmental Pollution, 179, 194-200.
65. Fries, E., and W. Puttmann. 2003. Monitoring of the Three

[[Page 17611]]

Organophosphate Esters Tbp, TCEP and Tbep in River Water and Ground 
Water (Oder, Germany). Journal of Environmental Monitoring, 5(2), 
346-352.
66. Garcia-Lopez, M., I. Rodriguez, and R. Cela. 2010. Mixed-Mode 
Solid-Phase Extraction Followed by Liquid Chromatography-Tandem Mass 
Spectrometry for the Determination of Tri- and Di-Substituted 
Organophosphorus Species in Water Samples. Journal of 
Chromatography. A, 1217(9), 1476-1484.
67. Kim, S.D., J. Cho, I.S. Kim, B.J. Vanderford, and S.A. Snyder. 
2007. Occurrence and Removal of Pharmaceuticals and Endocrine 
Disruptors in South Korean Surface, Drinking, and Waste Waters. 
Water Research, 41(5), 1013-1021.
68. Martinez-Carballo, E., C. Gonzalez-Barreiro, A. Sitka, S. 
Scharf, and O. Gans. 2007. Determination of Selected Organophosphate 
Esters in the Aquatic Environment of Austria. Science of The Total 
Environment, 388(1-3), 290-299.
69. Matamoros, V., C.A. Arias, L.X. Nguyen, V. Salvado, and H. Brix. 
2012. Occurrence and Behavior of Emerging Contaminants in Surface 
Water and a Restored Wetland. Chemosphere, 88(9), 1083-1089.
70. Quednow, K., and W. Puttmann. 2009. Temporal Concentration 
Changes of Deet, TCEP, Terbutryn, and Nonylphenols in Freshwater 
Streams of Hesse, Germany: Possible Influence of Mandatory 
Regulations and Voluntary Environmental Agreements. Environmental 
Science and Pollution Research, 16(6), 630-640.
71. Quednow, K., and W. Puttmann. 2008. Organophosphates and 
Synthetic Musk Fragrances in Freshwater Streams in Hessen/Germany. 
CLEAN--Soil, Air, Water, 36(1), 70-77.
72. Regnery, J., and W. Puttmann. 2010. Occurrence and Fate of 
Organophosphorus Flame Retardants and Plasticizers in Urban and 
Remote Surface Waters in Germany. Water Research, 44(14), 4097-4104.
73. Rodil, R., J.B. Quintana, E. Concha-Grana, P. Lopez-Mahia, S. 
Muniategui-Lorenzo, and D. Prada-Rodriguez. 2012. Emerging 
Pollutants in Sewage, Surface and Drinking Water in Galicia (Nw 
Spain). Chemosphere, 86(10), 1040-1049.
74. Schwarzbauer, J., and S. Heim. 2005. Lipophilic Organic 
Contaminants in the Rhine River, Germany. Water Research, 39(19), 
4735-4748.
75. Stepien, D.K., J. Regnery, C. Merz, and W. Puttmann. 2013. 
Behavior of Organophosphates and Hydrophilic Ethers During Bank 
Filtration and Their Potential Application as Organic Tracers. A 
Field Study from the Oderbruch, Germany. Science of The Total 
Environment, 458-460, 150-159.
76. Weigel, S., K. Bester, and H. Huhnerfuss. 2005. Identification 
and Quantification of Pesticides, Industrial Chemicals, and 
Organobromine Compounds of Medium to High Polarity in the North Sea. 
Marine Pollution Bulletin, 50(3), 252-263.
77. Yoon, Y., J. Ryu, J. Oh, B.G. Choi, and S.A. Snyder. 2010. 
Occurrence of Endocrine Disrupting Compounds, Pharmaceuticals, and 
Personal Care Products in the Han River (Seoul, South Korea). 
Science of The Total Environment, 408(3), 636-643.
78. Chen, D., R. Letcher, N. Burgess, L. Champoux, J. Elliott, C. 
Hebert, P. Martin, M. Wayland, D. Weseloh, and L. Wilson. 2012. 
Flame Retardants in Eggs of Four Gull Species (Laridae) from 
Breeding Sites Spanning Atlantic to Pacific Canada. Environmental 
Pollution, 168, 1-9.
79. EPA. Response to Petition to Order Testing of the Chlorinated 
Phosphate Ester (CPE) Cluster Under Section 4(a) of the Toxic 
Substances Control Act. 2017.
80. EPA. Assessments for TSCA Work Plan Chemicals. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/assessments-tsca-work-plan-chemicals. (retrieved on March 15, 2017).
81. EPA. Docket EPA-HQ-OPPT-2015-0068. 2016. https://www.regulations.gov/docket?D=EPA-HQ-OPPT-2015-0068.
82. EPA. Procedures for Chemical Risk Evaluation under the Amended 
Toxic Substances Control Act; Proposed Rule. Federal Register (82 FR 
7565, January 19, 2017) (FRL-9957-75). https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0654-0001.
83. EPA. Procedures for Prioritization of Chemicals for Risk 
Evaluation under Toxic Substances Control Act; Proposed Rule. 
Federal Register (82 FR 4826, January 17, 2017) (FRL-9957-74). 
https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0636-0001.
84. OECD. 2010. Test No 417: Toxicokinetics. Guideline for the 
testing of chemicals. OECD Guidelines for the Testing of Chemicals, 
Section 4: Health Effects. OECD Publishing, Paris.
85. OECD. 2004. Test No. 427: Skin Absorption: In Vivo Method. OECD 
Guidelines for the Testing of Chemicals, Section 4: Health Effects. 
OECD Publishing, Paris.
86. EPA. 1998a. Acute Dermal Toxicity (OPPTS Test Guideline 
870.1200).
87. Lynn, R.K.; Wong, C; Garvie-Gould, Kennish J.M. 1981 Disposition 
of the Flame Retardant, Tris(1.3-dichloro-2-propyl)phosphate, in the 
Rat. Drug Metab. Disp. 9(5):434-441.
88. Burka L.T., Sanders J.M., Herr D.W., Matthews H.B. 1991. 
Metabolism of Tris(2-chloroethyl)phosphate in Rats and Mice. Drug 
Metab Disp. 19(2):443-447.
89. Fang M., Stapleton H.M. 2014. Evaluating the Bioaccessibility of 
Flame Retardants in House Dust Using an In Vitro Tenax Bead Assisted 
Sorptive Physiologically Based Method. Environmental Science & 
Technology. 48:13323-13330.
90. Herr D.W., Sanders J.M., Matthews H.B. 1991. Brain Distribution 
and Fate of Tris(2-chloroethyl)phosphate in Fischer 344 Rats. Drug 
Metab Disp. 19(2):436-442.
91. Hughes M.F., Edwards B.C., Mitchell C..T, Bhooshan B. 2001. In 
Vitro Dermal Absorption of Flame Retardant Chemicals. Food Chem 
Toxicol. 39:1263-1270.
92. Marzulli F.N., Callahan B.S., Brown D.W.C. 1965. Chemical 
Structure and Skin Penetrating Capacity of a Short Series of Organic 
Phosphates and Phosphoric Acid. J Invest Derm. 44(5):339-344.
93. Minegashi K-I, Kurebayashi H., Seiichi, Namaru, Morimot K, 
Takahashi T, Yamaha T. 1988. Comparative Studies on Absorption, 
Distribution, and Excretion of Flame Retardants Halogenated Alkyl 
Phosphate in Rats. Eisei Kagaku 34(2):102-114.
94. Nomeir A.A., Kato D., Matthews H.B. 1981. The Metabolism and 
Disposition of Tris(1,3-dichloro-2-propyl)phosphate (Fryol FR-2) in 
the Rat. Toxicol Appl Pharm. 57:401-413.
95. Pawar G. Abdallah A-E, Villaverde de Saa E., Harrad S. 2017. 
Dermal Bioaccessibility of Flame Retadants from Indoor Dust and the 
Influence of Topically Applied Cosmetics. J Exp Scie Environ Epid. 
27:100-105.
96. EU (European Union). 2008a. European Union Risk Assessment 
Report: Tris(2-Chloro-1-Methylethyl) Phosphate (TCPP) CAS No: 13674-
84-5. Ireland and United Kingdom, Luxembourg. http://echa.europa.eu/documents/10162/6434698/orats_final_rar_tris2-chloro-1-methylethylphos_en.pdf.
97. EU (European Union). 2008b. European Union Risk Assessment 
Report: Tris[2-Chloro-1-(Chloromethyl)Ethyl] Phosphate (TDCP) CAS 
No: 13674-87-8. Ireland and United Kingdom, Luxembourg. http://echa.europa.eu/documents/10162/6434698/orats_final_rar_tris2-chloro-1-chloromethyleth_en.pdf.
98. EPA. 1998b. Acute Inhalation Toxicity (OPPTS Test Guideline 
870.1300).
99. Smyth H.F., Carpenter C.P. and Weil C.S. 1951. Range-finding 
toxicity data: List IV. Arch. Ind. Hyg. Occup. Med., 4, 119-122.
100. Environmental Affairs and Toxicology Department. 1981. Four 
hour acute inhalation toxicity study in Sprague-Dawley rats with 
2425-80 (Unpublished report).
101. Klassen, C.D. 2008. Editor: Cassarett and Doull's Toxicology: 
The Basic Science of Poisons. Seventh Edition. McGraw-Hill Medical 
Publishing Division. New York.
102. NTP (National Toxicology Program). n.d. Modified One-Generation 
Studies. https://ntp.niehs.nih.gov/testing/types/mog/index.html 
(retrieved in 2016).
103. EPA. 1998c. Reproduction and fertility effects (OPPTS Test 
Guideline 870.3800).
104. OECD. 2001.Test No 416: Two-Generation Reproduction Toxicity. 
OECD Guidelines for the Testing of Chemicals, Section 4: Health 
Effects. OECD Publishing, Paris.
105. NTP (National Toxicology Program). 1991b. Final Report on the 
Reproductive Toxicity of Tris (2-chloroethyl) phosphate (CAS No. 
115-96-8) in CD-1 Swiss Mice. RACB9204.
106. TNO Quality of Life. 2007. Oral two-generation reproduction 
toxicity study

[[Page 17612]]

(including a dose range finding study) with Tris(2-chloro-1-
methylethyl)-phosphate in rats. (Unpublished report).
107. Tanaka S., Nakaura S., Kawashima K., Nagao S., Endo T., Onoda 
K., Kasuya Y. and Omori Y. 1981. Effect of oral administration of 
tris(1,3-dichloroisopropyl) phosphate to pregnant rats on prenatal 
and post natal developments. Eisei Shikenjo Hokoku 99, 50-55. (in 
Japanese).
108. Stauffer Chemical Company. 1981b. Toxicology reports on FYROL 
FR-2 (volume I-II) with attachments and cover letters dated 020381. 
Submitted to the U.S. Environmental Protection Agency under TSCA 
Section 8E. EPA88-8100271. OTS0204911.
109. NTP, (National Toxicology Program). n.d. Testing Status of 
Tris(Chloropropyl)phosphate--M20263. https://ntp.niehs.nih.gov/testing/status/agents/ts-m20263.html (retrieved in 2017).
110. Chen G., Jin Y., Wu Y., Liu L., Fu Z. 2015. Exposure of male 
mice to two kinds of organophosphate flame retardants (OPFRs) 
induced oxidative stress and endocrine disruption. Environ Toxicol 
Pharmacol. 40:310-318
111. Farhat A., Crump D., Chiu S., Williams K.L., Letcher R.J., 
Gauthier L.T., Kennedy S.W. 2013. In Ovo effects of two 
organophosphate flame retardants--TCPP and TDCPP--on pipping 
success, development, mRNA expression, and thyroid hormone levels in 
chicken embryos. Tox Sci 134(1):92-102.
112. Kojima H., Takeuchi S., Itoh T., Iida M., Kobayashi S., Yoshida 
T. 2013. In vitro endocrine disruption potential of organophosphate 
flame retardants via human nuclear receptors. Toxicology. 14(1):76-
83.
113. Wang Q., Lai N.L., Wang X., Guo Y., Lam P.K., Lam J.C., Zhou B. 
2015a. Bioconcentration and transfer of the organophorous flame 
retardant 1,3-dichloro-2-propyl phosphate causes thyroid endocrine 
disruption and developmental neurotoxicity in zebrafish larvae. 
Environmental Science & Technology. 49(8):5123-32.
114. Wang Q., Lam J.C., Han J., Wang X., Guo Y., Lam P.K., Zhou B. 
2015b. Developmental exposure to the organophosphorus flame 
retardant tris(1,3-dichloro-2-propyl) phosphate: Estrogenic 
activity, endocrine disruption and reproductive effects on 
zebrafish. Aquatic Toxicol. 160:163-171.
115. Wang Q., Liang K., Liu J., Yang L., Guo Y., Liu C., Zhou B. 
2015c. Exposure of zebrafish embryos/larvae to TDCPP alters 
concentrations of thyroid hormones and transcriptions of genes 
involved in the hypothalamic-pituitary-thyroid axis. Aquatic 
Toxicol. 126:207-213.
116. Xu T., Wang Q., Shi Q., Fang Q., Guo Y., Zhou B. 2015. 
Bioconcentration, metabolism and alterations of thyroid hormones of 
Tris(1,3-dichloro-2-propyl) phosphate (TDCPP) in Zebrafish. 81-586. 
Environ Toxicol. Pharm. 40(2):5.
117. Zhang Q., Lu M., Dong X., Wang C., Zhang C., Liu W., Zhao M. 
2014. Potential estrogenic effects of phosphorus-containing flame 
retardants. Environmental Science & Technology. 48(12):6995-7001.
118. EPA. 2015. Larval amphibian growth and development assay 
(LAGDA) (OCSPP Test Guideline 890.2300).
119. Zaugg, S.D., Smith, S.G., Schroeder, M.P., Barber, L.B., 
Burkhardt, M.R. 2002. Methods of Analysis by the U.S. Geological 
Survey National Water Quality Laboratory--Determination of 
Wastewater Compounds by Polystyrene--Divinylbenzene Solid-Phase 
Extraction and Capillary-Column Gas Chromatography/Mass 
Spectrometry, Water-Resources Investigations Report 01-4186. U.S. 
Department of the Interior.
120. Rodil, R., Quintana, J.B., Reemtsma, T. 2005. Liquid 
Chromatography--Tandem Mass Spectrometry Determination of Nonionic 
Organophosphorus Flame Retardants and Plasticizers in Wastewater 
Samples, Anal. Chem. (77).
121. Unites States Geological Survey (USGS). National Water 
Information System. https://waterdata.usgs.gov/nwis (Retrieved on 
March 21, 2017).
122. Glassmeyer, S.T., Furlong, E.T., Kolpin, D.W., Cahill, J.D., 
Zaugg, S.D., Werner, S.L., Meyer, M.T., Kryak, D.D. 2005. Transport 
of Chemical and Microbial Compounds from Known Wastewater 
Discharges: Potential for Use as Indicators of Human Fecal 
Contamination, Environmental Science & Technology. (39).
123. Jackson, J., Sutton, R. 2008 Sources of Endocrine-Disrupting 
Chemicals in Urban Wastewater, Oakland, CA Sci. Tot. Environ. (405).
124. O'Brien, J.W., Thai, P.K., Brandsma, S.H., Leonards, P.E.G., 
Ort, C., Mueller, J.F. 2015. Wastewater analysis of Census Day 
Samples to Investigate per Capita Input of Organophosphorus Flame 
Retardants and Plasticizers into Wastewater. Chemosphere (138).
125. Schreder, E.D. and La Guardia, M.J. 2014 Flame Retardant 
Trnsfers from U.S. Households (Dust and Laundry Wastewater) to the 
Aquatic Environment, Environmental Science & Technology 48, 11575-
11583.
126. EPA. ChemSTEER-chemical screening tool for exposures and 
environmental releases. 2017. https://www.epa.gov/tsca-screening-tools/chemsteer-chemical-screening-tool-exposures-and-environmental-releases.
127. EPA. E-FAST-exposure and fate assessment screening tool version 
2014. 2017. https://www.epa.gov/tsca-screening-tools/e-fast-exposure-and-fate-assessment-screening-tool-version-2014.
128. EPA. AERMOD. Technology Transfer Network Support Center for 
Regulatory Atmospheric Modeling, Meteorological Processors and 
Accessory Programs. Air dispersion software. 2016. https://www3.epa.gov/ttn/scram/dispersion_prefrec.htm#aermod.
129. EPA. Office of Research and Development. Compendium Method TO-
9A: Determination Of Polychlorinated, Polybrominated And Brominated/
Chlorinated Dibenzo-p-Dioxins And Dibenzofurans In Ambient Air. 
1999. https://www3.epa.gov/ttnamti1/files/ambient/airtox/to-9arr.pdf.
130. Bradman, A., Castorina, R., Gaspar, F., Nishioka, M., Colon, 
M., Weathers, W., Egeghy, P.P., Maddalena, R., Williams, J., 
Jenkins, P.L., McKone, T.E. 2014. Flame Retardant Exposures in 
California Early Childhood Education Environments. Chemosphere 
(116).
131. Wei, G.-L., Li, D.-Q., Zhuo, M.-N., Liao, Y.-S., Xie, Z.-Y., 
Guo, T.-L., Li, J.-J, Zhang, S.-Y., Liang, Z.-Q. 2015. 
Organophosphorus Flame Retardants and Plasticizers: Sources, 
Occurrence, Toxicity and Human Exposure. Environ. Poll. (196).
132. Bester, K. 2005. Comparison of TCPP concentrations in sludge 
and wastewater in a typical German sewage treatment plant--
comparison of sewage sludge from 20 plants. 7: 509-513.
133. Olofsson, U., Bignert, A., Haglund, P. 2012. Time-trends of 
metals and organic contaminants in sewage sludge. Water research 46: 
4841-4851. http://www.ncbi.nlm.nih.gov/pubmed/22763293.
134. Fries, E., Mihajlovic, I. 2011. Pollution of Soils with 
Organophosphorus Flame Retardants and Plasticizers. J. Environ. 
Monit. (13).
135. Klosterhaus, S.L., Stapleton, H.M., LaGuardia, M.J., Greig, 
D.J. 2012. Brominated and Chlorinated Flame Retardants in San 
Francisco Bay Sediments and Wildlife. Environ. Intl. (47).
136. Regnery, J., Puttmann, W., Merz, C., Berthold, G., 2011. 
Occurrence and distribution of organophosphorus flame retardants and 
plasticizers in anthropogenically affected groundwater. J. Environ. 
Monit. 13, 347-354.
137. Stackelberg, P.E., Furlong, E.T., Meyer, M.T., Zaugg, S.D., 
Henderson, A.K., Reissman, D.B. 2004. Persistence of pharmaceutical 
compounds and other organic wastewater contaminants in a 
conventional drinking-water-treatment plant. Sci. Tot. Environ. 329, 
99-113.
138. NIOSH. Assessment of Occupational Exposure to Flame Retardants. 
2014. https://ntp.niehs.nih.gov/ntp/about_ntp/bsc/2014/dec/nioshupdate_508.pdf.
139. OSHA. OSHA Technical Manual (OTM), OSHA Instruction TED 01-00-
015 [TED 1-0.15A]. https://www.osha.gov/dts/osta/otm/otm_ii/otm_ii_2.html.
140. Gorman Ng, M., Semple, S., Cherrie, J.W., Christopher, Y., 
Northage, C., Tielemans, E., Veroughstraete, V. and Von Tongeren, M. 
2012. The relationship between inadvertent ingestion and dermal 
exposure pathways: A new integrated conceptual model and a database 
of dermal and oral transfer efficiencies. Annals of Occupational 
Hygiene. 56, 9 (1000-1012).
141. M[auml]kinen, M.S., M[auml]kinen, M.R., Koistinen, J.T., 
Pasanen, A.L., Pasanen, P.O., Kalliokoski, P.J., & Korpi, A.M. 2009. 
Respiratory and dermal exposure

[[Page 17613]]

to organophosphorus flame retardants and tetrabromobisphenol A at 
five work environments. Environmental Science & Technology, 43(3), 
941-947. https://doi.org/10.1021/es802593t.
142. Washington State Department of Ecology. 2014. Flame Retardants 
in General Consumer and Children's Products. (Publication No. 14-04-
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]
BILLING CODE 6560-50-P



                                                                           Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Proposed Rules                                            17601

                                                    not interfere with continued                            DATES:  EPA’s response to this TSCA                    issuance, amendment, or repeal of a rule
                                                    maintenance of the 1997 ozone NAAQS                     section 21 petition was signed April 6,                under TSCA section 4, 6, or 8 or an
                                                    in the Area Middle Tennessee Area, or                   2017.                                                  order under TSCA section 4 or 5(e) or
                                                    with any other applicable CAA                           FOR FURTHER INFORMATION CONTACT:                       (f). A TSCA section 21 petition must set
                                                    requirement, has been placed in the                        For technical information contact:                  forth the facts that are claimed to
                                                    public docket for this action.                          Hannah Braun, Chemical Control                         establish the necessity for the action
                                                    V. Legal Authority                                      Division (7405M), Office of Pollution                  requested. EPA is required to grant or
                                                                                                            Prevention and Toxics, Environmental                   deny the petition within 90 days of its
                                                       The statutory authority for this action              Protection Agency, 1200 Pennsylvania                   filing. If EPA grants the petition, the
                                                    is granted to the EPA by Sections 211(h)                Ave. NW., Washington, DC 20460–0001;                   Agency must promptly commence an
                                                    and 301(a) of the Clean Air Act, as                     telephone number: (202) 564–5614;                      appropriate proceeding. If EPA denies
                                                    amended; 42 U.S.C. 7545(h) and                          email address: braun.hannah@epa.gov.                   the petition, the Agency must publish
                                                    7601(a).                                                   For general information contact: The                its reasons for the denial in the Federal
                                                    List of Subjects in 40 CFR Part 80                      TSCA-Hotline, ABVI-Goodwill, 422                       Register. A petitioner may commence a
                                                                                                            South Clinton Ave., Rochester, NY                      civil action in a U.S. district court to
                                                      Environmental protection,
                                                                                                            14620; telephone number: (202) 554–                    compel initiation of the requested
                                                    Administrative practice and procedures,
                                                                                                            1404; email address: TSCA-Hotline@                     rulemaking proceeding within 60 days
                                                    Air pollution control, Fuel additives,
                                                                                                            epa.gov.                                               of either a denial or the expiration of the
                                                    Gasoline, Incorporation by reference,
                                                                                                                                                                   90-day period.
                                                    Motor vehicle and motor vehicle                         SUPPLEMENTARY INFORMATION:
                                                    engines, Motor vehicle pollution,                                                                              B. What criteria apply to a decision on
                                                                                                            I. General Information
                                                    Penalties, Reporting and recordkeeping                                                                         a TSCA section 21 petition?
                                                    requirements.                                           A. Does this action apply to me?
                                                                                                                                                                      1. Legal standard regarding TSCA
                                                      Dated: April 4, 2017.                                    This action is directed to the public               section 21 petitions. Section 21(b)(1) of
                                                    E. Scott Pruitt,                                        in general. This action may, however, be               TSCA requires that the petition ‘‘set
                                                    Administrator.                                          of interest to those persons who are or                forth the facts which it is claimed
                                                    [FR Doc. 2017–07399 Filed 4–11–17; 8:45 am]             may manufacture or process the                         establish that it is necessary’’ to issue
                                                    BILLING CODE 6560–50–P                                  chemicals tris(2-chloroethyl) phosphate                the rule or order requested. 15 U.S.C.
                                                                                                            (‘‘TCEP’’) (CAS No. 115–96–8), 2-                      2620(b)(1). Thus, TSCA section 21
                                                                                                            propanol, 1-chloro-, phosphate                         implicitly incorporates the statutory
                                                    ENVIRONMENTAL PROTECTION                                (‘‘TCPP’’) (CAS No. 13674–84–5), and 2-                standards that apply to the requested
                                                    AGENCY                                                  propanol, 1,3- dichloro-, phosphate                    actions. Accordingly, EPA has relied on
                                                                                                            (‘‘TDCPP’’) (CAS No. 13674–87–8).                      the standards in TSCA section 21 and in
                                                    40 CFR Chapter I                                        Since other entities may also be                       the provisions under which actions
                                                    [EPA–HQ–OPPT–2017–0038; FRL–9961–04]                    interested, the Agency has not                         have been requested to evaluate this
                                                                                                            attempted to describe all the specific                 TSCA section 21 petition. In addition,
                                                    Chlorinated Phosphate Ester (CPE)                       entities that may be affected by this                  TSCA section 21 establishes standards a
                                                    Cluster; TSCA Section 21 Petition;                      action.                                                court must use to decide whether to
                                                    Reasons for Agency Response                                                                                    order EPA to initiate an order in the
                                                                                                            B. How can I access information about
                                                    AGENCY:  Environmental Protection                       this petition?                                         event of a lawsuit filed by the petitioner
                                                    Agency (EPA).                                                                                                  after denial of a TSCA section 21
                                                                                                              The docket for this TSCA section 21                  petition. 15 U.S.C. 2620(b)(4)(B).
                                                    ACTION: Petition; reasons for Agency                    petition, identified by docket
                                                    response.                                                                                                         2. Legal standard regarding TSCA
                                                                                                            identification (ID) number EPA–HQ–                     section 4 rules. EPA must make several
                                                    SUMMARY:   This document provides the                   OPPT–2017–0038, is available at http://                findings in order to issue a rule or order
                                                    reasons for EPA’s response to a petition                www.regulations.gov or at the Office of                to require testing under TSCA section
                                                    it received under the Toxic Substances                  Pollution Prevention and Toxics Docket                 4(a)(1)(A)(i). In all cases, EPA must find
                                                    Control Act (TSCA). The TSCA section                    (OPPT Docket), Environmental                           that information and experience are
                                                    21 petition was received from                           Protection Agency Docket Center (EPA/                  insufficient to reasonably determine or
                                                    Earthjustice, Natural Resources Defense                 DC), West William Jefferson Clinton                    predict the effects of a chemical
                                                    Council, Toxic-Free Future, Safer                       Bldg., Rm. 3334, 1301 Constitution Ave.                substance on health or the environment
                                                    Chemicals, Healthy Families, BlueGreen                  NW., Washington, DC. The Public                        and that testing of the chemical
                                                    Alliance, and Environmental Health                      Reading Room is open from 8:30 a.m. to                 substance is necessary to develop the
                                                    Strategy Center on January 6, 2017. The                 4:30 p.m., Monday through Friday,                      missing information. 15 U.S.C.
                                                    petitioners requested that EPA issue an                 excluding legal holidays. The telephone                2603(a)(1). In addition, EPA must find
                                                    order under TSCA section 4, requiring                   number for the Public Reading Room is                  that the chemical substance may present
                                                    that testing be conducted by                            (202) 566–1744, and the telephone                      an unreasonable risk of injury under
                                                    manufacturers and processors of                         number for the OPPT Docket is (202)                    section 4(a)(1)(A)(i). Id. If EPA denies a
                                                    chlorinated phosphate esters (‘‘CPE’’).                 566–0280. Please review the visitor                    petition for a TSCA section 4 rule or
                                                    The CPE Cluster is composed of tris(2-                  instructions and additional information                order and the petitioners challenge that
mstockstill on DSK30JT082PROD with PROPOSALS




                                                    chloroethyl) phosphate (‘‘TCEP’’) (CAS                  about the docket available at http://                  decision, TSCA section 21 allows a
                                                    No. 115–96–8), 2-propanol, 1-chloro-,                   www.epa.gov/dockets.                                   court to order EPA to initiate the action
                                                    phosphate (‘‘TCPP’’) (CAS No. 13674–                    II. TSCA Section 21                                    requested by the petitioner if the
                                                    84–5), and 2-propanol, 1,3- dichloro-,                                                                         petitioner demonstrates to the
                                                    phosphate (‘‘TDCPP’’) (CAS No. 13674–                   A. What is a TSCA section 21 petition?                 satisfaction of the court by a
                                                    87–8). After careful consideration, EPA                   Under TSCA section 21 (15 U.S.C.                     preponderance of the evidence in a de
                                                    denied the TSCA section 21 petition for                 2620), any person can petition EPA to                  novo proceeding that findings very
                                                    the reasons discussed in this document.                 initiate a rulemaking proceeding for the               similar to those described in this unit


                                               VerDate Sep<11>2014   16:50 Apr 11, 2017   Jkt 241001   PO 00000   Frm 00008   Fmt 4702   Sfmt 4702   E:\FR\FM\12APP1.SGM   12APP1


                                                    17602                  Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Proposed Rules

                                                    with respect to a chemical substance                    that ecological toxicity from exposure to                 With the evidence of toxicity and
                                                    have been met.                                          TCEP and TDCPP was exhibited in                        exposure the petitioners argue that the
                                                                                                            acute tests with fish resulting in loss of             chemicals in the CPE Cluster meet the
                                                    III. Summary of the TSCA Section 21
                                                                                                            coordination, edema, darker                            criteria for ‘‘may present an
                                                    Petition
                                                                                                            pigmentation and hyperventilation (Ref.                unreasonable risk of injury to health or
                                                    A. What action was requested?                           2).                                                    the environment.’’
                                                       On January 6, 2017, Earthjustice,                      • EPA’s Design for the Environment                      The petitioners also assert there is
                                                    Natural Resources Defense Council,                      in which the Agency conducted a                        ‘‘insufficient information’’ on the CPE
                                                    Toxic-Free Future, Safer Chemicals,                     hazard assessment of the chemicals in                  Cluster chemicals. They indicate that
                                                    Healthy Families, BlueGreen Alliance,                   the CPE cluster and found that each of                 EPA’s Problem Formulation and Initial
                                                    and Environmental Health Strategy                       the three cluster members are                          Assessment (Ref. 2) ‘‘identifies seven
                                                    Center petitioned EPA to issue an order                 considered a high hazard for more than                 critical data gaps around exposures and
                                                    under TSCA section 4(a)(1), 90 days                     one human health effect, as well as for                hazards of these flame retardants’’.
                                                    after the petition was filed, requiring                 aquatic toxicity, based on empirical                   While EPA disagrees that the Problem
                                                    that testing be conducted by                            data. Additionally, TCPP and TDCPP                     Formulation and Initial Assessment
                                                    manufacturers and processors of the                     are considered to be highly persistent                 specifically identifies those which the
                                                    chlorinated phosphate esters (‘‘CPE’’)                  (Ref. 8).                                              petitioners assert, the petition lists the
                                                    Cluster composed of tris(2-chloroethyl)                   • The state of California finds TDCPP                following seven data gaps around
                                                    phosphate (‘‘TCEP’’) (CAS No. 115–96–                   to be a ‘‘known carcinogen,’’ and in                   exposures and hazard of CPE flame
                                                    8), 2-propanol, 1-chloro-, phosphate                    2011 California added TDCPP to the list                retardants:
                                                    (‘‘TCPP’’) (CAS No. 13674–84–5), and 2-                 of chemicals requiring warning labels                     Exposure pathways: Dermal and
                                                    propanol, 1,3- dichloro-, phosphate                     under California Proposition 65 law                    inhalation;
                                                    (‘‘TDCPP’’) (CAS No. 13674–87–8) (Ref.                  (Ref. 9, 10).                                             2. Hazard: Reproduction and
                                                    1).                                                       • California’s Proposition 65 list of                endocrine toxicity;
                                                                                                            chemicals where TCEP was ‘‘known to                       3. Exposure: Environmental releases
                                                    B. What support do the petitioners offer?               the State to cause cancer’’ in 1992 (Ref.              from non-industrial uses;
                                                      The petitioners cite to section 4(a)(1)               11).                                                      4. Exposure: Community and worker
                                                    of TSCA, which requires EPA to direct                     • The European Union (EU)                            exposures from manufacturing,
                                                    testing on a chemical substance or                      classifying TCEP as a ‘‘Substance of                   processing, industrial and non-
                                                    mixture if the Administrator finds the                  Very High Concern’’ based on                           industrial uses;
                                                    following criteria are met:                             reproductive toxicity (Ref. 12).                          5. Exposure: Community and worker
                                                      1. The manufacture, distribution in                     • California’s Safer Consumer                        exposures recycling;
                                                    commerce, processing, use, or disposal                  Products program listing TCPP as a                        6. Exposure: Community, worker and
                                                    of a chemical substance or mixture, or                  candidate chemical based on                            environmental exposures from disposal;
                                                    that any combination of such activities,                carcinogenicity (Ref. 13).                             and
                                                    may present an unreasonable risk of                       The petitioners assert there are CPE                    7. Hazard: Toxicity to birds, wildlife,
                                                    injury to health or the environment.                    Cluster chemicals exposure to humans                   sediment organisms.
                                                      2. There is insufficient information                  and the environment based on the                          The petitioners argue that the testing
                                                    and experience upon which the effects                   following information provided in                      recommended in the petition is critical
                                                    of such manufacture, distribution in                    EPA’s Problem Formulation and Initial                  to address this allegedly insufficient
                                                    commerce, processing, use, or disposal                  Assessment (Ref. 2).                                   information and for performing any
                                                    of such substance or mixture, or of any                   • Several studies of U.S. drinking                   TSCA section 6 risk evaluation of the
                                                    combination of such activities on health                water where CPEs have been detected                    CPE Cluster chemicals.
                                                    or the environment can reasonably be                    (Refs. 14–16).                                         IV. Disposition of TSCA Section 21
                                                    determined or predicted.                                  • Numerous studies where                             Petition
                                                      3. Testing is necessary to develop                    concentrations of CPEs in infant
                                                    such information.                                       products such as high chairs, bath mats,               A. What was EPA’s response?
                                                      The petitioners assert that the CPE                   car seats, nursing pillows, carriers,                     After careful consideration, EPA
                                                    Cluster chemicals ‘‘may present an                      sofas, and camping tents have been                     denied the petition. A copy of the
                                                    unreasonable risk of injury to health or                measured (Refs. 17–21).                                Agency’s response, which consists of
                                                    the environment’’ because there is                        • Small children may have additional                 two letters to the signatory petitioners
                                                    substantial evidence that chemicals in                  exposures through contact with baby                    from Earthjustice and Natural Resources
                                                    the CPE Cluster may be toxic, including:                products containing CPEs and via                       Defense Council (Ref. 79), is available in
                                                      • EPA’s TSCA Work Plan Chemical                       mouthing behaviors (Ref. 2).                           the docket for this TSCA section 21
                                                    Problem Formulation and Initial                           • A number of published studies                      petition.
                                                    Assessment—Chlorinated Phosphate                        where levels of CPEs in indoor air and
                                                    Ester Cluster Flame Retardants                          dust have been reported (Refs. 19–49).                 B. Background Considerations for the
                                                    (heretofore referred to as Problem                        • Several studies throughout the                     Petition
                                                    Formulation and Initial Assessment),                    United States and abroad which                            EPA published a Problem
                                                    which cites multiple mammalian                          reported levels of the CPEs in surface                 Formulation and Initial Assessment for
mstockstill on DSK30JT082PROD with PROPOSALS




                                                    toxicity studies showing adverse effects                water. Collectively, these data indicate               the CPE Cluster chemicals in August
                                                    caused by the cluster members such as                   high potential for exposures to                        2015 (Ref. 2). As stated on EPA’s Web
                                                    reproductive and developmental effects,                 ecological receptors, and in particular,               site titled ‘‘Assessments for TSCA Work
                                                    neurological effects, liver, kidney and                 aquatic organisms (Refs. 50–77).                       Plan Chemicals’’ (Ref. 80), ‘‘As a first
                                                    thyroid effects and cancer (for certain                   • A study where TCEP, TCPP, and                      step in evaluating TSCA Work Plan
                                                    cluster members) (Refs. 2–7).                           TDCPP have all been measured in                        Chemicals, EPA performs problem
                                                      • EPA’s Problem Formulation and                       herring gull eggs from the Lake Huron                  formulation to determine if available
                                                    Initial Assessment, which also states                   area (Ref. 78).                                        data and current assessment approaches


                                               VerDate Sep<11>2014   16:50 Apr 11, 2017   Jkt 241001   PO 00000   Frm 00009   Fmt 4702   Sfmt 4702   E:\FR\FM\12APP1.SGM   12APP1


                                                                           Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Proposed Rules                                          17603

                                                    and tools will support the assessments.’’               increase transparency of EPA’s thinking                to proceed to risk evaluation. Rather,
                                                    During development of the Problem                       and analysis process, provide                          such a decision indicates an area in
                                                    Formulation and Initial Assessment                      opportunity for public/stakeholders to                 which EPA will need to further evaluate
                                                    document for the CPE Cluster                            comment on EPA’s approach and                          the range of potential approaches—
                                                    chemicals, EPA followed an approach                     provide additional information/data to                 including generation of additional test
                                                    developed for assessing chemicals                       supplement or refine our assessment                    data—for proceeding to risk evaluation.
                                                    under TSCA as it existed at that time.                  approach prior to EPA conducting                       EPA is actively developing and evolving
                                                    In addition, in Table 2–1 of the Problem                detailed risk analysis and risk                        approaches for implementing the new
                                                    Formulation and Initial Assessment                      characterization’’ (Ref. 80).                          provisions in amended TSCA. These
                                                    (Ref. 2), EPA specified, in very general                   EPA’s 2015 Problem Formation and                    approaches are expected to address
                                                    terms, the nature and type of                           Initial Assessment for the CPE Cluster                 many, if not all, of the data needs
                                                    information sought to inform this                       chemicals does not constitute a full risk              asserted in the petition. Whereas under
                                                    particular risk assessment, under the                   assessment for the chemicals in the CPE                the Work Plan assessment effort, EPA
                                                    existing TSCA framework.                                Cluster, nor does it purport to be a final             sometimes opted not to include
                                                       Under TSCA prior to the June                         analysis plan for performing a risk                    conditions of use for which data were
                                                    amendments, EPA performed risk                          assessment or to present the results of                limited or lacking, under section 6 of
                                                    assessments on individual uses,                         a comprehensive search for available                   amended TSCA, EPA will evaluate all
                                                    hazards, and exposure pathways. The                     data or approaches for conducting risk                 conditions of use and will apply a broad
                                                    approach taken during the TSCA Work                     assessments. Rather, it is a preliminary               range of scientifically defensible
                                                    Plan assessment effort was to focus risk                step in the risk assessment process,                   approaches—using data, predictive
                                                    assessments on those conditions of use                  which EPA desired to publish to                        models, or other methods—that are
                                                    that were most likely to pose concern,                  provide transparency and the                           appropriate and consistent with the
                                                    and for which EPA identified the most                   opportunity for public input. EPA                      provisions of TSCA section 26, to
                                                    robust readily available, existing,                     received comments from Earthjustice,                   characterize risk and enable the
                                                    empirical data, located using targeted                  Natural Resources Defense Council and                  Administrator to make a determination
                                                    literature searches, although modeling                  others during the public comment                       of whether the chemical substance
                                                    approaches and alternative types of data                period, which ended in November 2015                   presents an unreasonable risk.
                                                    were also considered. EPA relied                        (Ref. 81). After the public comment
                                                    heavily on previously conducted                         period, EPA was in the process of                      C. What was EPA’s reason for this
                                                    assessments by other authoritative                      considering this input in refining the                 response?
                                                    bodies and well-established                             analysis plan and further data collection                 For the purpose of making its decision
                                                    conventional risk assessment                            for conducting a risk assessment for the               on the response to the petition, EPA
                                                    methodologies in developing the                         CPE Cluster chemicals.                                 evaluated the information presented or
                                                    Problem Formulation documents.                             On June 22, 2016, Congress passed the               referenced in the petition and its
                                                    Although EPA identified existing                        Frank R. Lautenberg Chemical Safety for                authority and requirements under TSCA
                                                    information and presented it in the                     the 21st Century Act. EPA has                          sections 4 and 21. EPA also evaluated
                                                    Problem Formulation and Initial                         interpreted the amended TSCA as                        relevant information that was available
                                                    Assessment, EPA did not necessarily                     requiring that forthcoming risk                        to EPA during the 90-day petition
                                                    undertake a comprehensive search of                     evaluations encompass all                              review period that may have not been
                                                    available information or articulate a                   manufacturing, processing, distribution                available or identified during the
                                                    range of scientifically supportable                     in commerce, use, and disposal                         development of EPA’s Problem
                                                    approaches that might be used to                        activities that the Administrator                      Formulation and Initial Assessment
                                                    perform risk assessment for various                     determines are intended, known, or                     (Ref. 2).
                                                    uses, hazards, and exposure pathways                    reasonably foreseen (Ref. 83). This                       EPA agrees that the manufacture,
                                                    in the absence of directly applicable,                  interpretation of ‘‘conditions of use’’ as             distribution in commerce, processing,
                                                    empirical data prior to seeking public                  defined by TSCA section 3(4), has                      use, or disposal of the CPE Cluster
                                                    input. Rather, EPA generally elected to                 prompted EPA to re-visit the scoping                   chemicals may present an unreasonable
                                                    focus its attention on the uses, hazards,               and problem formulation for risk                       risk of injury to health or the
                                                    and exposure pathways that appeared to                  assessments under TSCA. Other                          environment under TSCA section
                                                    be of greatest concern and for which the                provisions included in the amended                     4(a)(1)(A). EPA also agrees that the
                                                    most extensive relevant information had                 TSCA, including section 4(h) regarding                 Problem Formulation and Initial
                                                    been identified. (Ref. 2).                              alternative testing methods, have also                 Assessment was not comprehensive in
                                                       As EPA explains on its Web site,                     prompted EPA to evolve its approach to                 scope with regard to the conditions of
                                                    ‘‘Based on on-going experience in                       scoping and conducting risk                            use of the CPE Cluster chemicals,
                                                    conducting TSCA Work Plan Chemical                      evaluations. The requirement to                        exposure pathways/routes, or
                                                    assessments and stakeholder feedback,                   consider all conditions of use in risk                 potentially exposed populations.
                                                    starting in 2015 EPA will publish a                     evaluations—and to do so during the                    However, the Problem Formulation and
                                                    problem formulation for each TSCA                       three to three and a half years allotted               Initial Assessment was not designed to
                                                    Work Plan assessment as a stand-alone                   in the statute—has led EPA to more                     be comprehensive. Rather, the Problem
                                                    document to facilitate public and                       fully evaluate the range of data sources               Formulation and Initial Assessment was
                                                    stakeholder comment and input prior to                  and technically sound approaches for                   developed under EPA’s then-existing
mstockstill on DSK30JT082PROD with PROPOSALS




                                                    conducting further risk analysis.                       conducting risk evaluations. Thus, a                   process, as explained previously. It was
                                                    Commensurate with release of a                          policy decision articulated in a problem               a fit-for-purpose document to meet a
                                                    problem formulation document, EPA                       formulation under the pre-amendment                    TSCA Work Plan (i.e., pre-Lautenberg
                                                    will open a public docket for receiving                 TSCA not to proceed with risk                          Act) need. Going forward under TSCA,
                                                    comments, data or information from                      assessment for a particular use, hazard,               as amended, EPA will conform its
                                                    interested stakeholders. EPA believes                   or exposure pathway does not                           analyses to TSCA, as amended. EPA has
                                                    publishing problem formulations for                     necessarily indicate at this time that                 explained elsewhere how the Agency
                                                    TSCA Work Plan assessments will                         EPA will need to require testing in order              proposes to conduct prioritization and


                                               VerDate Sep<11>2014   16:50 Apr 11, 2017   Jkt 241001   PO 00000   Frm 00010   Fmt 4702   Sfmt 4702   E:\FR\FM\12APP1.SGM   12APP1


                                                    17604                  Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Proposed Rules

                                                    risk evaluation going forward (Refs. 82                 and absorption, distribution,                             Furthermore, EPA’s use of available
                                                    and 83). However, EPA does not find                     metabolism and excretion (ADME) data                   existing toxicity information reduces the
                                                    that the petitioners have demonstrated,                 (Refs. 7, 87–96) that could be used to                 use of vertebrate animals in the testing
                                                    for each exposure pathway and hazard                    perform route-to-route extrapolation                   of chemical substances in a manner
                                                    endpoint presented in the petition, that                from oral toxicity studies to predict                  consistent with provisions described in
                                                    the information and experience                          effects from dermal exposure to the CPE                TSCA section 4(h). 2. Reproductive and
                                                    available to EPA are insufficient to                    Cluster chemicals.                                     Endocrine Toxicity. a. Reproductive
                                                    reasonably determine or predict the                        Furthermore, EPA’s use of available                 Toxicity. The petition does not set forth
                                                    effects on health or the environment                    existing toxicity information reduces the              facts demonstrating that there is
                                                    from ‘‘manufacture, distribution in                     use of vertebrate animals in the testing               insufficient data available to EPA to
                                                    commerce, processing, use, or disposal’’                of chemical substances in a manner                     reasonably determine or predict the
                                                    (or any combination of such activities)                 consistent with provisions described in                reproductive toxicity of the CPE Cluster
                                                    of the CPE Cluster chemicals nor that                   TSCA section 4(h).                                     chemicals. The NTP Modified One
                                                    the specific testing they have identified                  b. Inhalation toxicity. The petition                Generation study (Ref. 102) or the
                                                    is necessary to develop such                            does not set forth facts demonstrating                 alternatively suggested in vivo
                                                    information.                                            that there is insufficient information                 reproductive toxicity screening test
                                                       The discussion that follows provides                 available to EPA to reasonably                         (OPPTS 870.3800: Reproduction and
                                                    the reasons for EPA’s decision to deny                  determine or predict effects to health                 Fertility Effects) (Ref. 103) based on
                                                    the petition based on the finding that for              from inhalation exposure to the CPE                    two-generation reproduction toxicity
                                                    each requested test the information on                  Cluster chemicals. The toxicokinetics                  test (OECD Test Guideline 416) (Ref.
                                                    the individual exposure pathways and                    test (OECD Test Guideline 417:                         104), requested by the petitioners, may
                                                    hazard endpoints identified by the                      Toxicokinetics) (Ref. 84) and inhalation               not be needed. Although EPA states in
                                                    petitioners do not demonstrate that                     toxicity test (OPPTS Test Guideline                    the Problem Formulation and Initial
                                                    there is insufficient information upon                  870.1300: Acute Inhalation Toxicity)                   Assessment that ‘‘given uncertainty
                                                    which the effects of the CPE Cluster                    (Ref. 98) requested by the petitioners                 surrounding the impact of long-term
                                                    chemicals can reasonably be determined                  may not be needed. In the Problem                      exposures and male reproductive
                                                    or predicted or that the requested testing              Formulation and Initial Assessment,                    toxicity, it would not be possible to
                                                    is necessary to develop additional                      EPA stated that risk from the inhalation               quantify risks at this time,’’ EPA now
                                                    information. The sequence of EPA’s                      exposure pathway could not be                          believes, after further review and
                                                    responses follows the sequence in                       quantified for risk assessment because                 consideration of existing studies, that
                                                    which requested testing was presented                   of a lack of route-specific toxicological              the Agency could use information
                                                    in the petition (Ref. 1). 1. Dermal and                 data, but also indicated that an                       identified in the Problem Formulation
                                                    Inhalation Exposure Toxicity. a. Dermal                 alternative approach, i.e., development                and Initial Assessment, as well as new
                                                    toxicity. The petition does not set forth               of a PBPK model for oral, inhalation and               information identified through
                                                    facts demonstrating that there is                       dermal routes of exposure would                        comprehensive literature searches, data
                                                    insufficient information available to                   provide the ability to perform route-to-               from alternative testing approaches, and
                                                    EPA to reasonably determine or predict                  route extrapolation. The Problem                       read-across (in which data for one
                                                    effects to health from dermal exposure                  Formulation and Initial Assessment,                    structurally similar chemical can be
                                                    to the CPE Cluster chemicals. The                       indicated that adequate toxicokinetic                  used to assess the toxicity of another)
                                                    toxicokinetics test (Organization for                   data would be needed for each route of                 could be used to conduct an assessment
                                                    Economic Co-operation and                               exposure and that these data are lacking               of effects of the CPE Cluster chemicals
                                                    Development (OECD) Test Guideline                       for inhalation exposures. However,                     on reproduction (Ref. 2). As presented
                                                    417) (Ref. 84), in vivo absorption test                 since the publication of the Problem                   in the Problem Formulation and Initial
                                                    (OECD Test Guideline 427) (Ref. 85) and                 Formulation and Initial Assessment,                    Assessment, EPA identified several
                                                    dermal toxicity test (OPPTS Test                        EPA has identified toxicological data                  studies for each chemical in the CPE
                                                    Guideline 870.1200) (Ref. 86) requested                 including, acute toxicity,                             Cluster to assess reproductive effects.
                                                    by the petitioners may not be needed. In                bioaccessibility and ADME data (Refs. 7,               Specifically, a multi-generation
                                                    the Problem Formulation and Initial                     87–89, 93, 99 and 100) that could be                   reproductive and developmental
                                                    Assessment, EPA stated that risk from                   used in route-to-route extrapolation                   toxicity study in mice for TCEP (Ref.
                                                    the dermal exposure pathway could not                   from oral toxicity studies to predict                  105) and a two-generation reproductive
                                                    be quantified for risk assessment                       effects from inhalation exposure to the                and developmental study in rats for
                                                    because of a lack of route-specific                     CPE Cluster chemicals. As proposed in                  TCPP (Ref. 106, test data currently listed
                                                    toxicological data, but also indicated                  the Problem Formulation and Initial                    as CBI) were identified. For TDCPP, a
                                                    that an alternative approach, i.e.,                     Assessment, CPE Cluster chemicals that                 reproduction study in male rabbits (Ref.
                                                    development of a PBPK model for oral,                   are absorbed to and inhaled associated                 7), two developmental toxicity studies
                                                    inhalation and dermal routes of                         with particles, once the particles are in              in female rats (Refs. 7 and 107) and a
                                                    exposure would provide the ability to                   the gastrointestinal tract, absorption                 two-year cancer bioassay in rats, which
                                                    perform route-to-route extrapolation.                   would be the same as in the oral toxicity              included evaluation of effects on
                                                    The Problem Formulation and Initial                     studies and hence, oral toxicity studies               reproductive organs (Ref. 108), are
                                                    Assessment indicated that adequate                      can be used to determine or predict                    already available.
mstockstill on DSK30JT082PROD with PROPOSALS




                                                    toxicokinetic data would be needed for                  effects to health from inhalation                         Since the publication of the Problem
                                                    each route of exposure and that these                   exposure to the CPE cluster substances.                Formulation Initial Assessment
                                                    data are lacking for dermal exposures.                  Current literature on bioaccessibility                 document, EPA identified additional
                                                    However, since the publication of the                   (Ref. 89) could also be used to refine the             reproductive studies. Specifically, TCPP
                                                    Problem Formulation and Initial                         estimate of the amount of the CPE                      has been evaluated in a developmental
                                                    Assessment document, EPA has                            Cluster chemicals absorbed via                         toxicity study (Ref. 109). The results of
                                                    identified pharmacokinetic data                         ingestion of particles (via inhalation and             this study have not yet been released,
                                                    including absorption, bioaccessibility                  translocation to the gut).                             but are expected to be available to EPA


                                               VerDate Sep<11>2014   19:57 Apr 11, 2017   Jkt 241001   PO 00000   Frm 00011   Fmt 4702   Sfmt 4702   E:\FR\FM\12APP1.SGM   12APP1


                                                                           Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Proposed Rules                                           17605

                                                    prior to initiation of a Risk Evaluation                evidence (i.e., weight of evidence)                    11 waste water treatment plants (Ref.
                                                    for TCPP. EPA has also identified                       would be undertaken to identify                        124). Another study, identified in the
                                                    studies using alternative animal models                 endocrine-related hazard concerns. 3.                  Problem Formulation and Initial
                                                    and in vitro tests that could inform the                Environmental Releases from Non-                       Assessment, compares influent water
                                                    evaluation of reproductive toxicity                     Industrial and Consumer Uses. The                      concentrations between the U.S. and
                                                    (Refs. 110–117). Finally, given the                     petition does not set forth facts                      Sweden (Ref. 29) and indicates that U.S.
                                                    structural similarity of the three                      demonstrating that there is insufficient               concentration values are comparable to
                                                    chemicals in the CPE Cluster, EPA                       information available to EPA to                        Sweden, suggesting that data from
                                                    could consider read-across approaches,                  reasonably determine or predict effects                Sweden could also be considered in a
                                                    using data from one chemical to                         of the CPE Cluster chemicals associated                U.S. assessment.
                                                    characterize the hazards of another                     with environmental releases from non-                     EPA has identified existing effluent
                                                    chemical. Collectively, the studies                     industrial and consumer uses nor                       data from municipal treatment plants
                                                    identified in the Problem Formulation                   specifically the potential contribution of             for TCEP and TDCPP from the U.S.
                                                    and Initial Assessment document, the                    down-the-drain releases of the CPE                     Geological Survey National Water
                                                    studies identified since the release of                 Cluster chemicals in United States                     Information System (Ref. 121) since the
                                                    the Problem Formulation and Initial                     waters. EPA agrees with the petitioner’s               publication of the Problem Formulation
                                                    Assessment document, and read-across                    suggestion that existing data (e.g.,                   and Initial Assessment document.
                                                    approaches, could be used to                            effluent and influent of wastewater)                   Several other studies also indicate the
                                                    characterize reproductive toxicity for                  could be used to estimate environmental                presence of CPE Cluster chemicals in
                                                    the CPE Cluster chemicals.                              concentrations of the CPE Cluster                      U.S. wastewater (Refs. 55 and 122). One
                                                       Furthermore, EPA’s use of available                  chemicals from consumer and down-the                   study shows low levels of TCEP in a
                                                    existing toxicity information reduces the               drain uses. Hence, development of                      sample from U.S. industrial laundry
                                                    use of vertebrate animals in the testing                sampling plans for effluent waters from                wastewater (Ref. 123), a potential down-
                                                    of chemical substances in a manner                      municipal treatment plants and                         the drain contributor to treatment plant
                                                    consistent with provisions described in                 analytical methods for measuring the                   effluent. Other wastewater samples in
                                                    TSCA section 4(h).                                      CPE Cluster chemicals may not be                       the industrial laundry study showed
                                                       b. Endocrine Activity. The petition                  needed.                                                non-detect levels of TCEP. EPA agrees
                                                    does not set forth facts demonstrating                     While EPA’s Problem Formulation                     with the petitioners that these types of
                                                    that there is insufficient information                  and Initial Assessment indicated that                  data may be especially useful to
                                                    available to EPA to reasonably                          contributions of non-industrial and                    estimate potential contributions from
                                                    determine or predict the effects of the                 consumer uses to water and wastewater                  down-the-drain uses to water and
                                                    CPE Cluster chemicals on endocrine                      were not quantifiable, EPA’s conceptual                wastewater CPE concentrations. Hence,
                                                    activity. EPA believes that the Larval                  model did indicate that exposures to                   as the petitioners suggest, EPA could
                                                    Amphibian Growth and Development                        water and wastewater (aggregated from                  use a combination of existing
                                                    Assay (OCSPP 890.2300) (Ref. 118) or                    all sources) would be assessed. EPA                    occurrence data, especially effluent and
                                                    the alternatively suggested NTP                         agrees, as the petition suggests, that                 influent of wastewater from municipal
                                                    Modified One Generation Study (Ref.                     existing effluent and influent from                    treatment plants (e.g., U.S. effluent data
                                                    102) requested by the petitioners may                   wastewater could likely be used to                     and non-U.S. data) to determine or
                                                    not be needed. EPA’s Problem                            predict environmental concentrations of                predict contributions from non-
                                                    Formulation and Initial Assessment                      the CPE Cluster chemicals from                         industrial and consumer uses, including
                                                    stated that data were conflicting with                  consumer and other down-the drain                      the potential contribution of down-the-
                                                    regard to endocrine activity, which                     uses. As identified in the Problem                     drain releases. EPA believes that the
                                                    made it difficult to make a                             Formulation and Initial Assessment,                    monitoring and effluent data described
                                                    determination in the pre-assessment                     there are over 100 available monitoring                previously, as well as additional data
                                                    phase. However, EPA did not consider                    studies that could be used to                          that describes non-industrial or
                                                    the information to be insufficient; rather              characterize concentrations of the CPE                 consumer sources to wastewater (Ref.
                                                    EPA intended to defer drawing                           Cluster chemicals in water and                         125) that may be identified during
                                                    conclusions until the assessment phase                  wastewater. Monitoring studies range                   prioritization of the CPE Cluster for risk
                                                    when additional, comprehensive review                   from nationwide studies with larger                    evaluation is likely sufficient for
                                                    of all available data would be                          sample sizes and consistent analytical                 characterizing risk from exposures to
                                                    conducted.                                              methods such as United States                          water and wastewater and for assessing
                                                       A number of studies evaluating                       Geological Survey (USGS), to targeted                  potential contributions from non-
                                                    thyroidal and other endocrine effects are               studies with generally smaller sample                  industrial and consumer down-the-
                                                    available, including the reproduction                   sizes and variable analytical methods.                 drain releases of the CPE Cluster
                                                    and developmental toxicity studies                         In addition, several studies from other             chemicals. As the petitioners point out,
                                                    described in Unit IV.C.2.a. (Refs. 7, 105,              countries are also available to                        this approach of using existing
                                                    106 and 108), as well as studies using                  characterize the CPE Cluster chemicals                 monitoring data and especially
                                                    alternative animal models and in vitro                  in water and wastewater. Since the                     wastewater effluent data has been used
                                                    tests (Refs. 110–117) identified since the              publication and Problem Formulation                    by others (i.e., Environment and Climate
                                                    Problem Formulation and Initial                         and Initial Assessment document, an                    Change Canada) to assess the potential
mstockstill on DSK30JT082PROD with PROPOSALS




                                                    Assessment. An evaluation of each                       Australian study (Ref. 124), sampled for               contribution to down-the-drain releases
                                                    study as well as the full body of                       all three members of the CPE Cluster in                (Ref. 2).




                                               VerDate Sep<11>2014   16:50 Apr 11, 2017   Jkt 241001   PO 00000   Frm 00012   Fmt 4702   Sfmt 4702   E:\FR\FM\12APP1.SGM   12APP1


                                                    17606                  Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Proposed Rules

                                                       EPA believes that the development of                 approaches. Monitoring data exist for                  EPA could use a combination of models
                                                    analytical methods for the                              the CPE Cluster chemicals. As identified               (e.g. ChemSTEER and AERMOD) to
                                                    determination and quantification of the                 in the Problem Formulation Initial                     predict deposition to soil near facilities
                                                    CPE Cluster chemicals in sampled                        Assessment, there are over 100 available               in conjunction with predicted
                                                    waters and the development of a                         monitoring studies that could be used to               environmental releases to air. The
                                                    strategy for sampling effluent waters                   characterize concentrations of the CPE                 modeled data in combination with
                                                    from municipal treatment plants as                      Cluster chemicals in various media (Ref.               measurements of the CPE Cluster
                                                    requested by the petitioners is not                     2).                                                    chemicals in other media such as
                                                    needed at this time. Analytical methods                    Air. The petition does not set forth                sludge, biosolids, and effluent as
                                                    for TCEP, TCPP and TDCPP already                        facts demonstrating that there is                      identified in the Problem Formulation
                                                    exist as evidenced by measurements                      insufficient information available to                  and Initial Assessment (Refs. 40, 55,
                                                    performed by the USGS and other                         EPA to reasonably determine or predict                 122, 132 and 133) could be used to
                                                    laboratories (Refs. 119 and 120). The                   effects from exposure through air in                   estimate soil concentrations from land
                                                    petition does not establish why these                   communities near manufacturing,                        application of sludge and effluent.
                                                    are insufficient. 4. Exposure from                      processing, industrial and non-                        There is also a study in Germany,
                                                    manufacturing, processing, industrial                   industrial use facilities of the CPE                   identified since the publication of the
                                                    and non-industrial uses. a.                             Cluster chemicals. Air sampling, using                 Problem Formulation and Initial
                                                    Communities. The petition does not set                  methods such as EPA Air Method Toxic                   Assessment, showing concentrations
                                                    forth facts demonstrating that there is                 Organics-9A (TO–9A, Determination of                   (ranging from approximately 2–20 mg/kg
                                                    insufficient information available to                   Polychlorinated, Polybrominated and                    dry weight) of TCEP and TCPP in soil
                                                    EPA to reasonably determine or predict                  Brominated/Chlorinated Dibenzo-p-                      from grasslands and two urban sites
                                                    effects from exposure to air, soil and                  Dioxins and Dibenzofurans in Ambient                   (Ref. 134) which also could be evaluated
                                                    water in communities near                               Air) (Ref. 129), in the vicinity of                    for use in predicting soil concentrations
                                                    manufacturing, processing, industrial                   representative manufacturing and                       in communities near manufacturing and
                                                    and non-industrial use facilities of the                processing facilities, as requested by the             processing facilities. However, the
                                                    CPE Cluster chemicals. The petitioners                  petitioners may not be necessary. EPA                  petition does not address these
                                                    state that in the absence of facility                   could use existing approaches, such as                 possibilities, let alone explain why a
                                                    specific Toxic Release Inventory (TRI)                  modeling (ChemSTEER, E–FAST and                        testing order under section 4 would be
                                                    data, other information sources should                  AERMOD) (Refs. 126–128) along with                     necessary at this point. EPA considers
                                                    be used to identify relevant facilities to              existing data to estimate releases and air             this approach to be reasonable to
                                                    monitor near. EPA agrees with the                       concentrations near facilities for the                 determine exposure to communities
                                                    petitioners that other sources of                       CPE Cluster chemicals.                                 near manufacturing and processing
                                                                                                               The modeled data in combination                     facilities, but may decide to pursue
                                                    information, such as Chemical Data
                                                                                                            with measurements of the CPE Cluster                   targeted sampling in the future near
                                                    Reporting (CDR), can be used to identify
                                                                                                            chemicals in ambient air as identified in              manufacturing and processing facilities
                                                    relevant facilities on which exposure
                                                                                                            the Problem Formulation and Initial                    to reduce uncertainty.
                                                    estimates could be made.
                                                                                                            Assessment for the U.S. and abroad                        Water. The petition does not set forth
                                                       Although the Problem Formulation                     (Refs. 40, 49, 130 and 131), could be                  facts demonstrating that there is
                                                    and Initial Assessment states that                      used to estimate air concentrations in                 insufficient information available to
                                                    chemical-specific environmental release                 communities near manufacturing and                     EPA to reasonably determine or predict
                                                    data to air, soil and water from                        processing facilities. However, the                    effects from exposure through water in
                                                    industrial sites could not be found (Ref.               petition does not address these                        communities near manufacturing,
                                                    2), EPA believes that approaches other                  possibilities, let alone explain why a                 processing, and industrial and non-
                                                    than site-specific monitoring could be                  testing order under section 4 would be                 industrial use facilities of the CPE
                                                    used to assess potential exposures from                 necessary at this point. EPA considers                 Cluster chemicals. Sampling studies,
                                                    manufacturing, processing, industrial                   this approach to be reasonable to                      especially for various types of water
                                                    and non-industrial uses. EPA believes it                determine exposure to communities                      (e.g., drinking water, surface water, and
                                                    could be reasonable to estimate or                      near manufacturing and processing                      ground water) may not be necessary.
                                                    model releases from facilities and                      facilities, but may decide to pursue                   EPA could use existing measured
                                                    concentrations in the surrounding                       targeted sampling in the future near                   chemical-specific environmental data
                                                    environments using established EPA                      manufacturing and processing facilities                and modeling to estimate releases and
                                                    models such as ChemSTEER, E–FAST                        to reduce uncertainty.                                 water concentrations near facilities.
                                                    and AERMOD. ChemSTEER is a model                           Soil. The petition does not set forth                  For example, surface water
                                                    to estimate workplace exposure and                      facts demonstrating that there is                      concentrations near known facilities can
                                                    environmental releases (Ref. 126). E–                   insufficient information available to                  be estimated using existing approaches,
                                                    FAST is a tool to estimate                              EPA to reasonably determine or predict                 such as E–FAST and ChemSTEER along
                                                    concentrations of chemicals released to                 effects from exposure through soil in                  with estimated releases from these
                                                    air, water, landfills and consumer                      communities near manufacturing,                        activities (Refs. 126 and 127). As
                                                    products (Ref. 127). AERMOD is a                        processing, industrial and non-                        identified in the Problem Formulation
                                                    model to estimate chemical emissions                    industrial use facilities of the CPE                   and Initial Assessment, data are
                                                    from stationary industrial sources (Ref.                Cluster chemicals. Soil sampling, using                available for surface water
mstockstill on DSK30JT082PROD with PROPOSALS




                                                    128). All of these models have been                     EPA methods, in the vicinity of                        concentrations of TCEP and TDCPP
                                                    extensively reviewed and validated                      representative manufacturing and                       from USGS NWIS as well as other
                                                    based on comparisons with monitoring                    processing facilities, as requested by the             studies. Surface water monitoring data
                                                    data. These modeled estimates could be                  petitioners may not be necessary.                      for TCPP are available in the open
                                                    compared to existing U.S. monitoring                    Although the Problem Formulation and                   literature (Refs. 50, 55 and 135).
                                                    data, which is not site-specific, and non-              Initial Assessment stated that ‘‘Studies               Groundwater concentrations near
                                                    U.S. data associated with industrial                    of soil with measured U.S. values are                  known facilities can also be
                                                    facilities to assess the modeling                       not readily available’’ (Ref. 2 Page 67),              characterized using models such as E–


                                               VerDate Sep<11>2014   16:50 Apr 11, 2017   Jkt 241001   PO 00000   Frm 00013   Fmt 4702   Sfmt 4702   E:\FR\FM\12APP1.SGM   12APP1


                                                                           Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Proposed Rules                                           17607

                                                    FAST and ChemSTEER (Refs. 126 and                       and dermal routes of exposure as the                   regarding Air Sampling, are sufficient to
                                                    127).                                                   basis for not further elaborating these                characterize exposures to workers at
                                                       Furthermore, groundwater data are                    exposure pathways. However, as                         manufacturing or processing facilities
                                                    available for TCEP and TDCPP from                       described in Unit IV.C.1., EPA has                     from exposure to dust. Sampling of
                                                    USGS NWIS in addition to other                          described data and approaches that may                 settled dust (surface wipe and bulk
                                                    monitoring studies that have reported                   be useful in filling these data gaps such              sampling) using the OSHA Technical
                                                    concentrations (generally ranging from                  that this may not be a critical data gap               Manual (Ref. 139), as requested by the
                                                    non-detect to approximately 1 mg/L) for                 going forward. Additionally, the                       petitioners, may not be necessary.
                                                    all three CPE Cluster chemicals (Refs. 65               petitioners cited a report from the                    During Problem Formulation and Initial
                                                    and 136).                                               National Institute of Occupational                     Assessment, EPA stated that inhalation
                                                       As with surface and groundwater,                     Safety and Health (NIOSH) titled:                      and dermal exposure were the primary
                                                    drinking water concentrations near                      ‘‘Assessment of Occupational Exposure                  routes of occupational exposure for the
                                                    known facilities could also be estimated                to Flame Retardants’’ that aims to                     CPE Cluster chemicals. Presence of the
                                                    from releases using modeling (e.g., E–                  quantify and characterize occupational                 CPE Cluster chemicals in settled dust
                                                    FAST and ChemSTEER). Furthermore,                       exposure routes (inhalation, ingestion,                may indicate additional dermal and
                                                    drinking water data from samples taken                  or dermal) for CPE Cluster chemicals as                ingestion exposures are possible.
                                                    at drinking water treatment plants are                  potentially useful for EPA to consider                 However, surface wipe sampling does
                                                    available for TCPP, TCEP and TDCPP                      (Ref. 138). EPA agrees that this report                not provide a direct estimate of dermal
                                                    from several studies that have reported                 appears to include a number of                         or ingestion exposure. Surface wipe
                                                    concentrations generally ranging from                   scenarios and measurements for which                   sampling would need to be combined
                                                    non-detect to approximately 1 mg/L                      the petitioners are asking for testing and             with information on transfer efficiency
                                                    (Refs. 14–16 and 137).                                  that EPA would consider any relevant                   between the surface, hands, and objects
                                                       In summary, EPA could use modeled                    information that results from this on-                 as well as the number of events to
                                                    data in combination with measurements                   going study. However, the petition fails               estimate exposures from ingestion (Ref.
                                                    of the CPE Cluster chemicals in water to                to explain how it considered worker                    140).
                                                    estimate water concentrations in                        exposure or why a testing order under                     EPA notes that in the ongoing NIOSH
                                                    communities near manufacturing and                      section 4 would be necessary for                       study (Ref. 138) surface wipe sampling
                                                    processing facilities. However, the                     additional information.                                is not included, which provides support
                                                    petition does not address these                            If measured data are not available, it              for the conclusion that settled dust is
                                                    possibilities, let alone explain why a                  is still possible to assess exposure using             not a customary measure for
                                                    testing order under section 4 would be                  modelling approaches. Specifically,                    occupational exposure. Furthermore,
                                                    necessary at this point. EPA considers                  EPA’s ChemSTEER could be used to                       EPA would use any information
                                                    this approach to be reasonable to                       estimate worker exposure under a                       generated from the NIOSH study
                                                    determine exposure to communities                       number of manufacturing, processing                    considered relevant for this exposure
                                                    near manufacturing and processing                       and use scenarios (Ref. 126). In                       pathway.
                                                    facilities, but may decide to pursue                    addition, EPA may be able to use air                      Biomonitoring. EPA believes the
                                                    targeted sampling in the future near                    concentration information or an                        approaches described previously are
                                                    manufacturing and processing facilities                 estimation approach for a structurally                 sufficient to characterize exposures to
                                                    to reduce uncertainty.                                  similar chemical to estimate work                      workers at manufacturing or processing
                                                       b and c. Workers (Industrial and Non-                exposures under specific industrial or                 facilities from external doses/
                                                    Industrial). The petition states that                   non-industrial scenarios. However, the                 concentrations. The biomonitoring data
                                                    ‘‘Occupational assessments, including                   petition does not address these                        collected following the protocols of the
                                                    biological and environmental                            possibilities, let alone explain why a                 ongoing NIOSH study or other peer-
                                                    monitoring, should be conducted in                      testing order under section 4 would be                 reviewed studies, as requested by the
                                                    representative manufacturing,                           necessary at this point. EPA considers                 petitioners, is not needed. EPA would,
                                                    processing and industrial use facilities’’              these approaches to be reasonable to                   however, consider any data or
                                                    and that ‘‘Occupational assessments                     determine exposure to workers of                       information generated from the NIOSH
                                                    based on personal monitoring should be                  manufacturing and processing facilities,               study deemed to be relevant and
                                                    used for non-industrial workers’’ (Ref.                 but may decide to pursue targeted                      applicable for discerning exposures
                                                    1).                                                     sampling in the future for workers in                  from all exposure routes. 5. Exposures
                                                       Air Sampling. The petition does not                  manufacturing and processing facilities                from recycling. The petition does not set
                                                    set forth facts demonstrating that there                to reduce uncertainty.                                 forth facts demonstrating that there is
                                                    is insufficient information available to                   Dust Sampling. The petition does not                insufficient information available to
                                                    EPA to reasonably determine or predict                  set forth facts demonstrating that there               EPA to reasonably determine or predict
                                                    effects from exposure to the CPE Cluster                is insufficient information available to               effects to communities and workers
                                                    chemicals through air for workers in                    EPA to reasonably determine or predict                 specifically located at or near facilities
                                                    manufacturing, processing, industrial                   effects from exposure to the CPE Cluster               that recycle the CPE Cluster chemical-
                                                    and non-industrial use facilities. EPA                  chemicals through dust for workers in                  containing products. EPA believes that
                                                    believes that a combination of modeled                  manufacturing, processing, industrial                  the approaches requested by the
                                                    data and existing data (e.g., non-U.S.                  and non-industrial use facilities. EPA                 petitioners to measure exposure to the
                                                    data for similar activities/scenarios)                  believes that a combination of                         CPE Cluster chemicals from recycling
mstockstill on DSK30JT082PROD with PROPOSALS




                                                    could be used to determine or predict                   modelling and existing data (e.g., non-                facilities may not be needed. These are
                                                    effects on workers exposed to air                       U.S. data) could allow EPA to determine                the same approaches referenced in Unit
                                                    containing the CPE Cluster chemicals in                 or predict effects on workers exposed to               IV.C.4.a.b. and c. EPA did not include
                                                    an industrial and non-industrial                        dust containing the CPE Cluster                        in the Problem Formulation and Initial
                                                    environment.                                            chemicals in an industrial and non-                    Assessment a search for data associated
                                                       The CPE Problem Formulation and                      industrial environment.                                with the recycling of the CPE Cluster
                                                    Initial Assessment document states that                    EPA believes the approaches                         chemicals. Going forward, EPA would
                                                    EPA’s lack of toxicity data for inhalation              described earlier, Unit IV.C.4.b. and c.               initiate a comprehensive search of


                                               VerDate Sep<11>2014   16:50 Apr 11, 2017   Jkt 241001   PO 00000   Frm 00014   Fmt 4702   Sfmt 4702   E:\FR\FM\12APP1.SGM   12APP1


                                                    17608                  Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Proposed Rules

                                                    available data. EPA could then assess                      With such data or information, the                  of chemical substances in a manner
                                                    the nature of the data, including those                 recycling processes used in the U.S.                   consistent with provisions described in
                                                    cited by the petitioners (Refs. 141–143)                could potentially be assessed. However,                TSCA section 4(h).
                                                    to determine feasibility of conducting an               the petition does not address this                        Soil/Sediment dwelling organisms.
                                                    assessment. For example, the following                  possibility, let alone explain why a                   The petition does not set forth facts
                                                    could inform development of exposure                    testing order under section 4 would be                 demonstrating that there is insufficient
                                                    scenarios for recycling facilities within               necessary at this point.                               information available to EPA to
                                                    the United States:                                         EPA also notes that the NIOSH study                 reasonably determine or predict the CPE
                                                       a. The number and location of                        (Ref. 138), may inform occupational                    Cluster chemicals’ effects to soil/
                                                    recycling facilities in the United States;              exposures from disposal facilities and                 sediment dwelling organisms. The
                                                       b. The types and volumes of products                 could be considered in an occupational                 Earthworm Subchronic Toxicity Test
                                                    that are accepted by these sites; and                   assessment of the CPE Cluster                          (OCSPP 850.3100) (Ref. 152) as
                                                       c. the recycling and disposal methods                chemicals. EPA also notes that the                     requested by petitioners is not needed.
                                                    employed at these facilities.                           settled dust sampling and biomonitoring                Although the Problem Formulation and
                                                       With such information, the recycling                 data, as requested by the petitioners,                 Initial Assessment states that data was
                                                    processes used in the U.S. could                        may not be the most appropriate data to                not available to characterize risk for
                                                    potentially be assessed. However, the                   collect for the reasons provided                       sediment dwelling organisms (Ref. 2),
                                                    petition does not address this                          previously in Unit IV.C.4.b. and c., but               adequate sediment toxicity studies exist
                                                    possibility, let alone explain why a                    that EPA would consider any data or                    for TDCPP and this data could also be
                                                    testing order under section 4 would be                  information generated from the NIOSH                   used to evaluate and characterize the
                                                    necessary on this point.                                study deemed to be relevant and                        effects of the other CPE Cluster
                                                       EPA also notes that the NIOSH study                  applicable for discerning exposures                    chemicals to sediment dwelling
                                                    (Ref. 138) may inform occupational                      from any/all exposure routes. 7.                       organisms using read-across. There are
                                                    exposures from recycling facilities and                 Exposures of birds, wildlife and                       chronic toxicity studies on three
                                                                                                            sediment organisms.                                    sediment-dwelling species, Chironomus
                                                    could be considered in an occupational
                                                                                                               Terrestrial organism toxicity. The                  riparius (midge), Hyallela Azteca
                                                    assessment of CPE Cluster chemicals.
                                                                                                            petition does not set forth facts                      (amphipod) and Lumbriculus variegatus
                                                    EPA also notes that the settled dust                    demonstrating that there is insufficient               (oligochaete) (Refs. 150–152). Since
                                                    sampling and biomonitoring data, as                     information available to EPA to                        publication of the Problem Formulation
                                                    requested by the petitioners, may not be                reasonably determine or predict CPE                    and Initial Assessment, EPA identified
                                                    the most appropriate data to collect for                Cluster chemicals’ effects to terrestrial              additional data on soil/sediment
                                                    the reasons provided previously in Unit                 organisms. The avian toxicity test                     dwelling organisms that could be used
                                                    IV.C.4.b. and c. EPA would consider any                 (OCSPP 850.2100: Avian Acute Oral                      to assess risks to these organisms (Refs.
                                                    data or information generated from the                  Toxicity Test) (Ref. 144) as requested by              153–155).
                                                    NIOSH study deemed to be relevant and                   the petitioners is not necessary.                         EPA considers the three chemicals in
                                                    applicable for discerning exposures                     Although the Problem Formulation and                   the CPE Cluster to have similar hazard
                                                    from all exposure routes. 6. Exposure                   Initial Assessment previously stated that              profiles from an ecological perspective
                                                    from disposal. The petition does not set                there was limited ability to quantify                  and hence, read-across, in which data
                                                    forth facts demonstrating that there is                 risks because of a lack of monitoring                  for one structurally similar chemical can
                                                    insufficient information available to                   data and hazard endpoints (Ref. 2),                    be used to assess the toxicity of another,
                                                    EPA to reasonably determine or predict                  studies have been identified since the                 could be appropriately applied. EPA’s
                                                    effects to communities and workers                      publication of the Problem Formulation                 conclusion regarding this approach is
                                                    specifically located at or near facilities              and Initial Assessment document                        supported by its use in risk assessments
                                                    that dispose of CPE Cluster chemical-                   including a study by Fernie et al. (2013)              performed by the European Union (Refs.
                                                    containing products. EPA believes that                  measuring toxicity of all three CPE                    96, 97, and 148). Collectively, the
                                                    the approaches requested by the                         Cluster chemicals to American Kestrels                 available data could be used to
                                                    petitioners to measure exposure to the                  (Ref. 145) using a modified Avian                      determine or predict the effects of the
                                                    CPE Cluster chemicals from disposal                     Dietary Toxicity Test (OCSPP 850.2200)                 CPE Cluster chemicals on soil/sediment
                                                    facilities may not be needed. These are                 (Ref. 146), and a study on the toxicity                dwelling organisms.
                                                    the same approaches referenced in Unit                  of TCEP to hens (Ref. 147).                               Plant toxicity. The petition does not
                                                    IV.C.4.a.b. and c. EPA did not include                     EPA considers the three chemicals in                set forth facts demonstrating that there
                                                    in the Problem Formulation and Initial                  the CPE Cluster to have similar hazard                 is insufficient information available to
                                                    Assessment a search for data associated                 profiles from an ecological perspective                EPA to reasonably determine or predict
                                                    with the disposal of the CPE Cluster                    and hence, read-across, in which data                  the CPE Cluster chemicals effects on
                                                    chemicals. Going forward, EPA would                     for one structurally similar chemical can              plants. The Early Seedling Growth
                                                    initiate a comprehensive search of                      be used to assess the toxicity of another,             Toxicity Test (OCSPP 850.4230) (Ref.
                                                    available data. EPA could then assess                   could be appropriately applied. EPA’s                  156) as requested by the petitioners is
                                                    the nature of the data to determine                     conclusion regarding this approach is                  not needed. Since publication of the
                                                    feasibility of conducting an assessment.                supported by its use in risk assessments               Problem Formulation and Initial
                                                    For example, the following could inform                 performed by the European Union (Refs.                 Assessment document, EPA identified
                                                    development of exposure scenarios for                   96, 97 and 148). Collectively, the                     data on the toxicity to terrestrial plants
mstockstill on DSK30JT082PROD with PROPOSALS




                                                    recycling facilities within the United                  available data could be used to                        from TDCPP (Ref. 157), TCEP (Ref. 158)
                                                    States:                                                 determine or predict the effects of the                and TCPP (Ref. 159). The data could be
                                                       a. The number and location of                        CPE Cluster chemicals on terrestrial                   used to determine or predict the effects
                                                    recycling facilities in the United States;              organism, specifically birds, from                     of the CPE Cluster chemicals on plants.
                                                       b. The types and volumes of products                 repeated exposures.                                       8. EPA’s conclusions. EPA denied the
                                                    that are accepted by these sites; and                      Furthermore, EPA’s use of available                 request to issue an order under TSCA
                                                       c. The recycling and disposal methods                existing toxicity information reduces the              section 4 because the TSCA section 21
                                                    employed at these facilities.                           use of vertebrate animals in the testing               petition does not set forth sufficient


                                               VerDate Sep<11>2014   16:50 Apr 11, 2017   Jkt 241001   PO 00000   Frm 00015   Fmt 4702   Sfmt 4702   E:\FR\FM\12APP1.SGM   12APP1


                                                                           Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Proposed Rules                                               17609

                                                    facts for EPA to find that the                               Pcf in Sprague-Dawley Rats.                            Environmental Science & Technology,
                                                    information currently available to the                       International Journal of Toxicology,                   47(9), 4449–4454.
                                                    Agency, including existing studies                           18(3), 173–176.                                   18. Stapleton, H.M., S. Klosterhaus, A.S.
                                                                                                            6. Tilson, H., B. Veronesi, R. McLamb, and                  Keller, P.L. Ferguson, S. van Bergen,
                                                    (identified prior to or after publication                                                                           E.M. Cooper, T.F. Webster, and A. Blum.
                                                                                                                 H. Matthews. 1990. Acute Exposure to
                                                    of EPA’s Problem Formulation and                             Tris(2-Chloroethyl) Phosphate Produces                 2011. Identification of Flame Retardants
                                                    Initial Assessment) on the CPE Cluster                       Hippocampal Neuronal Loss and Impairs                  in Polyurethane Foam Collected from
                                                    chemicals as well as alternate                               Learning in Rats. Toxicology and                       Baby Products. Environmental Science &
                                                    approaches for risk evaluation is                            Applied Pharmacology, 106(2), 254–269.                 Technology, 45(12), 5323–5331.
                                                    insufficient to permit a reasoned                       7. Anonymous. 1977. Health and safety data             19. Stapleton, H.M., S. Klosterhaus, S. Eagle,
                                                    determination or prediction of the                           for 4 chemicals with cover letter dated                J. Fuh, J.D. Meeker, A. Blum, and T.F.
                                                    health or environmental effects of the                       021089 (sanitized). Submitted to the U.S.              Webster. 2009. Detection of
                                                                                                                 Environmental Protection Agency under                  Organophosphate Flame Retardants in
                                                    CPE Cluster chemicals at issue in the
                                                                                                                 TSCA Section 8D. EPA86–8900001189.                     Furniture Foam and U.S. House Dust.
                                                    petition nor that the specific testing the                   OTS0516689.                                            Environmental Science & Technology,
                                                    petition identified is necessary to                     8. EPA. 2015b. Flame Retardants Used in                     43(19), 7490–7495.
                                                    develop additional information, as                           Flexible Polyurethane Foam: An                    20. Stapleton, H.M., S. Sharma, G. Getzinger,
                                                    elaborated throughout Unit IV. of this                       Alternatives Assessment Update. Doc.                   P.L. Ferguson, M. Gabriel, T.F. Webster,
                                                    notice.                                                      No. 744–R–15–002. https://www.epa.                     and A. Blum. 2012. Novel and High
                                                       Furthermore, to the extent the                            gov/sites/production/files/2015-08/                    Volume Use Flame Retardants in U.S.
                                                    petitioners request vertebrate testing,                      documents/ffr_final.pdf.                               Couches Reflective of the 2005 Pentabde
                                                    EPA emphasizes that future petitions                    9. Cal. EPA, Office of Environmental Health                 Phase Out. Environmental Science &
                                                                                                                 Hazard Assessment (OEHHA). Oct. 21,                    Technologynol, 46(24), 13432–13439.
                                                    should discuss why such testing is
                                                                                                                 2016. Chemicals Known to the State to             21. Keller, A.S., N.P. Raju, T.F. Webster, and
                                                    appropriate, considering the reduction                       Cause Cancer or Reproductive Toxicity                  H.M. Stapleton. 2014. Flame Retardant
                                                    of testing on vertebrates encouraged by                      21 http://oehha.ca.gov/media/                          Applications in Camping Tents and
                                                    TSCA section 4(h), as amended.                               downloads/proposition-65//p65single                    Potential Exposure. Environmental
                                                                                                                 10212016.pdf.                                          Science and Technology Letters(1), 152–
                                                    V. References
                                                                                                            10. OEHHA. July 2011. Reproductive and                      155.
                                                      The following is a listing of the                          Cancer Hazard Assessment Branch,                  22. Ali, N., A.C. Dirtu, N. Van den Eede, E.
                                                    documents that are specifically                              Evidence on the Carcinogenicity of                     Goosey, S. Harrad, H. Neels, A.
                                                    referenced in this document. The docket                      Tris(1,3-Dichloro-2-Propyl) Phosphate.                 Mannetje, J. Coakley, J. Douwes, and A.
                                                    includes these documents and other                           http://oehha.ca.gov/media/downloads/                   Covaci. 2012. Occurrence of Alternative
                                                    information considered by EPA,                               proposition-65/chemicals/tdcpp                         Flame Retardants in Indoor Dust from
                                                                                                                 070811.pdf.                                            New Zealand: Indoor Sources and
                                                    including documents that are referenced
                                                                                                            11. OEHHA. Oct. 21, 2016. Chemicals Known                   Human Exposure Assessment.
                                                    within the documents that are included                       to the State to Cause Cancer or                        Chemosphere, 88(11), 1276–1282.
                                                    in the docket, even if the referenced                        Reproductive Toxicity. http://oehha.ca.           23. Ali, N., N. Van den Eede, A.C. Dirtu, H.
                                                    document is not physically located in                        gov/media/downloads/proposition-65//                   Neels, and A. Covaci. 2012. Assessment
                                                    the docket. For assistance in locating                       p65single10212016.pdf.                                 of Human Exposure to Indoor Organic
                                                    these other documents, please consult                   12. European Chemicals Agency. Nov. 27,                     Contaminants Via Dust Ingestion in
                                                    the technical person listed under FOR                        2009. Support Document for                             Pakistan. Indoor Air, 22(3), 200–211.
                                                    FURTHER INFORMATION CONTACT.                                 Identification of Tris(2-Chloroethyl)             24. Allen, J.G., H.M. Stapleton, J. Vallarino,
                                                                                                                 Phosphate as a Substance of Very High                  E. McNeely, M.D. McClean, S.J. Harrad,
                                                    1. Earthjustice, Natural Resources Defense                   Concern Because of its CMR Properties.                 C.B. Rauert, and J.D. Spengler. 2013.
                                                         Council, Toxic-Free Future, Safer                       https://echa.europa.eu/documents/                      Exposure to Flame Retardant Chemicals
                                                         Chemicals, Healthy Families, BlueGreen                  10162/6d09755f-7fcb-4a00-b7ce-91ab45                   on Commercial Airplanes.
                                                         Alliance, Environmental Health Strategy                 a2e5af.                                                Environmental Health, 12(17), 13.
                                                         Center; Eve Gartner, Earthjustice; and             13. See Cal SAFER. Candidate Chemical                  25. Bergh, C., R. Torgrip, G. Emenius, and C.
                                                         Veena Singla, Natural Resources Defense                 Details (last visited Jan. 4, 2017), https://          Ostman. 2011. Organophosphate and
                                                         Council to Gina McCarthy,
                                                                                                                 calsafer.dtsc.ca.gov/chemical/Chemical                 Phthalate Esters in Air and Settled
                                                         Administrator, Environmental Protection
                                                                                                                 Detail.aspx?chemid=20838.                              Dust—a Multi-Location Indoor Study.
                                                         Agency. Re: Petition to Order Testing of
                                                                                                            14. Benotti, M., R. Trenholm, B. Vanderford,                Indoor Air, 21, 67–76.
                                                         the Chlorinated Phosphate Ester Cluster
                                                                                                                 J. Holady, B. Stanford, and S. Snyder.            26. Brommer, S., S. Harrad, N. Van den Eede,
                                                         Flame Retardants (TCEP, TCPP and
                                                         TDCPP) under Section 4(a) of the Toxic                  2009. Pharmaceuticals and Endocrine                    and A. Covaci. 2012. Concentrations of
                                                         Substances Control Act. January 6, 2017.                Disrupting Compounds in U.S. Drinking                  Organophosphate Esters and Brominated
                                                    2. EPA. 2015a. TSCA Work Plan Chemical                       Water. Environmental Science &                         Flame Retardants in German Indoor Dust
                                                         Problem Formulation and Initial                         Technology, 43(3), 597–603.                            Samples. Journal of Environmental
                                                         Assessment Chlorinated Phosphate Ester             15. Snyder, S.A., E.C. Wert, H. Lei, P.                     Monitoring, 14(9), 2482–2487.
                                                         Cluster Flame Retardants.                               Westerhoff, and Y. Yoon. 2007. Removal            27. Carignan, C.C., M.D. McClean, E.M.
                                                    3. NTP (National Toxicology Program).                        of Edcs and Pharmaceuticals in Drinking                Cooper, D.J. Watkins, A.J. Fraser, W.
                                                         1991a.Toxicology and Carcinogenesis                     and Reuse Treatment Processes.                         Heiger-Bernays, H.M. Stapleton, and T.F.
                                                         Studies of Tris(2-Chloroethyl) Phosphate           16. Stackelberg, P.E., J. Gibs, E.T. Furlong,               Webster. 2013. Predictors of Tris(1,3-
                                                         (CAS No. 115–96–8) in F344/N Rats and                   M.T. Meyer, S.D. Zaugg, and R.L.                       Dichloro-2-Propyl) Phosphate Metabolite
                                                         B6c3f1 Mice (Gavage Studies).                           Lippincott. 2007. Efficiency of                        in the Urine of Office Workers.
                                                         Department of Health and Human                          Conventional Drinking-Water-Treatment                  Environment International, 55, 56–61.
                                                         Services. Research Triangle Park, NC.                   Processes in Removal of Pharmaceuticals           28. Dodson, R.E., L.J. Perovich, A. Covaci, N.
mstockstill on DSK30JT082PROD with PROPOSALS




                                                         NTP Technical Report 391.                               and Other Organic Compounds. Science                   Van den Eede, A.C. Ionas, A.C. Dirtu, J.G.
                                                    4. Freudenthal, R.I., and R.T. Henrich. 2000.                of The Total Environment, 377(2–3),                    Brody, and R.A. Rudel. 2012. After the
                                                         Chronic Toxicity and Carcinogenic                       255–272.                                               Pbde Phase-Out: A Broad Suite of Flame
                                                         Potential of Tris(1,3-Dichloro-2-Propyl)           17. Fang, M., T. Webster, D. Gooden, E.                     Retardants in Repeat House Dust
                                                         Phosphate in Sprague-Dawley Rat.                        Cooper, M. McClean, C. Carignan, C.                    Samples from California. Environmental
                                                         International Journal of Toxicology. 19,                Makey, and H. Stapleton. 2013.                         Science and Technology, 46(24), 13056–
                                                         119–125.                                                Investigating a Novel Flame Retardant                  13066.
                                                    5. Freudenthal, R.I., and R.T. Henrich. 1999.                Known as V6: Measurements in Baby                 29. Marklund, A., B. Andersson, and P.
                                                         A Subchronic Toxicity Study of Fyrol                    Products, House Dust, and Car Dust.                    Haglund. 2003. Screening of



                                               VerDate Sep<11>2014   16:50 Apr 11, 2017   Jkt 241001   PO 00000   Frm 00016   Fmt 4702   Sfmt 4702   E:\FR\FM\12APP1.SGM   12APP1


                                                    17610                  Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Proposed Rules

                                                         Organophosphorus Compounds and                          by Dynamic Sonication-Assisted Solvent                 Surveillance for Previously Unmonitored
                                                         Their Distribution in Various Indoor                    Extraction Coupled on-Line with Large-                 Organic Contaminants in the San
                                                         Environments. Chemosphere, 53(9),                       Volume Injection Gas Chromatography                    Francisco Estuary. Marine Pollution
                                                         1137–1146.                                              Utilizing a Programmed-Temperature                     Bulletin, 46(9), 1102–1110.
                                                    30. Meeker, J.D., and H.M. Stapleton. 2010.                  Vaporizer. Journal of Chromatography A,           54. Vanderford, B.J., R.A. Pearson, D.J.
                                                         House Dust Concentrations of                            993(1–2), 103–110.                                     Rexing, and S.A. Snyder. 2003. Analysis
                                                         Organophosphate Flame Retardants in                42. Staaf, T., and C. Ostman. 2005a. Indoor                 of Endocrine Disruptors,
                                                         Relation to Hormone Levels and Semen                    Air Sampling of Organophosphate                        Pharmaceuticals, and Personal Care
                                                         Quality Parameters. Environmental                       Triesters Using Solid Phase Extraction                 Products in Water Using Liquid
                                                         Health Perspectives, 118(3), 318–323.                   (Spe) Adsorbents. Journal of                           Chromatography/Tandem Mass
                                                    31. Takigami, H., G. Suzuki, Y. Hirai, Y.                    Environmental Monitoring (JEM), 7(4),                  Spectrometry. Analytical Chemistry,
                                                         Ishikawa, M. Sunami, and S. Sakai. 2009.                344–348.                                               75(22), 6265–6274.
                                                         Flame Retardants in Indoor Dust and Air            43. Staaf, T., and C. Ostman. 2005b.                   55. Vidal-Dorsch, D.E., S.M. Bay, K. Maruya,
                                                         of a Hotel in Japan. Environment                        Organophosphate Triesters in Indoor                    S.A. Snyder, R.A. Trenholm, and B.J.
                                                         International, 35(4), 688–693.                          Environments. Journal of Environmental                 Vanderford. 2012. Contaminants of
                                                    32. Cao, S., X. Zeng, H. Song, H. Li, Z. Yu,                 Monitoring (JEM), 7(9), 883–887.                       Emerging Concern in Municipal
                                                         G. Sheng, and J. Fu. 2012. Levels and              44. Tollback, J., D. Tamburro, C. Crescenzi,                Wastewater Effluents and Marine
                                                         Distributions of Organophosphate Flame                  and H. Carlsson. 2006. Air Sampling                    Receiving Water. Environmental
                                                         Retardants and Plasticizers in Sediment                 with Empore Solid Phase Extraction                     Toxicology and Chemistry, 31(12), 2674–
                                                         from Taihu Lake, China. Environmental                   Membranes and Online Single-Channel                    2682.
                                                         Toxicology and Chemistry, 31(7), 1478–                  Desorption/Liquid Chromatography/                 56. Andresen, J., and K. Bester. 2006.
                                                         1484.                                                   Mass Spectrometry Analysis:                            Elimination of Organophosphate Ester
                                                    33. Stapleton, H.M., J. Misenheimer, H.K.,                   Determination of Volatile and Semi-                    Flame Retardants and Plasticizers in
                                                         and T.F. Webster. 2014. Flame Retardant                 Volatile Organophosphate Esters. Journal               Drinking Water Purification. Water
                                                         Associations between Children’s                         of Chromatography. A, 1129(1), 1–8.                    Research, 40(3), 621–629.
                                                         Handwipes and House Dust.                          45. Kanazawa, A., I. Saito, A. Araki, M.               57. Andresen, J., A. Grundmann, and K.
                                                         Chemosphere, 116, 54–60.                                Takeda, M. Ma, Y. Saijo, and R. Kishi.                 Bester. 2004. Organophosphorus Flame
                                                    34. Bergh, C., R. Torgrip, G. Emenius, and C.                2010. Association between Indoor                       Retardants and Plasticisers in Surface
                                                         Ostman. 2011. Organophosphate and                       Exposure to Semi-Volatile Organic                      Waters. Science of The Total
                                                         Phthalate Esters in Air and Settled                     Compounds and Building-Related                         Environment, 332(1–3), 155–166.
                                                                                                                 Symptoms among the Occupants of                   58. Andresen, J., D. Muir, D. Ueno, C.
                                                         Dust—a Multi-Location Indoor Study.
                                                                                                                                                                        Darling, N. Theobald, and K. Bester.
                                                         Indoor Air, 21, 67–76.                                  Residential Dwellings. Indoor Air, 20(1),
                                                                                                                                                                        2007. Emerging Pollutants in the North
                                                    35. Bjorklund, J., S. Isetun, and U. Nilsson.                72–84.
                                                                                                                                                                        Sea in Comparison to Lake Ontario,
                                                         2004. Selective Determination of                   46. Ohura, T., T. Amagai, Y. Senga, and M.
                                                                                                                                                                        Canada, Data. Environmental Toxicology
                                                         Organophosphate Flame Retardants and                    Fusaya. 2006. Organic Air Pollutants
                                                                                                                                                                        and Chemistry, 26(6), 1081–1089.
                                                         Plasticizers in Indoor Air by Gas                       Inside and Outside Residences in                  59. Bacaloni, A., F. Cucci, C. Guarino, M.
                                                         Chromatography, Positive-Ion Chemical                   Shimizu, Japan: Levels, Sources and                    Nazzari, R. Samperi, and A. Lagana.
                                                         Ionization and Collision-Induced                        Risks. Science of The Total Environment,               2008. Occurrence of Organophosphorus
                                                         Dissociation Mass Spectrometry. Rapid                   366(2–3), 485–499.                                     Flame Retardant and Plasticizers in
                                                         Communications in Mass Spectrometry,               47. Otake, T., J. Yoshinaga, and Y.                         Three Volcanic Lakes of Central Italy.
                                                         18(24), 3079–3083.                                      Yanagisawa. 2004. Exposure to Phthalate                Environmental Science and Technology,
                                                    36. Green, N., M. Schlabach, T. Bakke, E.                    Esters from Indoor Environment. Journal                42(6), 1898–1903.
                                                         Brevik, C. Dye, D. Herzke, S. Huber, B.                 of Exposure Analysis and Environmental            60. Bendz, D., N.A. Paxeus, T.R. Ginn, and
                                                         Plosz, M. Remberger, M. Schoyen, H.                     Epidemiology, 14, 524–528.                             F.J. JLoge. 2005. Occurrence and Fate of
                                                         Uggerud, and C. Vogelsang. 2008.                   48. Otake, T., J. Yoshinaga, and Y. Yukio                   Pharmaceutically Active Compounds in
                                                         Screening of Selected Metals and New                    Yanagisawa. 2001. Analysis of Organic                  the Environment, a Case Study: HüOje
                                                         Organic Contaminants, 2007. 5569–2008.                  Esters of Plasticizer in Indoor Air by GC-             River in Sweden. Journal of Hazardous
                                                         Norwegian Pollution Contral Agency,                     Ms and GC-Fpd. Environmental Science                   Materials, 122, 195–204.
                                                         Oslo, Norway.                                           & Technology, 35, 3099–3102.                      61. Bollmann, U., A. Moeler, Z. Xie, R.
                                                    37. Hartmann, P.C., D. Burgi, and W. Giger.             49. Saito, I., A. Onuki, and H. Seto. 2007.                 Ebinghaus, and J. Einax. 2012.
                                                         2004. Organophosphate Flame                             Indoor Organophosphate and                             Occurrence and Fate of
                                                         Retardants and Plasticizers in Indoor Air.              Polybrominated Flame Retardants in                     Organophosphorus Flame Retardants
                                                         Chemosphere, 57(8), 781–787.                            Tokyo. Indoor Air, 17(1), 28–36.                       and Plasticizers in Coastal and Marine
                                                    38. Ingerowski, G., A. Friedle, and J.                  50. Alvarez, D., K. Maruya, N. Dodder, W.                   Surface Waters. Water Research, 46(2),
                                                         Thumulla. 2001. Chlorinated Ethyl and                   Lao, E. Furlong, and K. Smalling. 2013.                531–538.
                                                         Isopropyl Phosphoricacid Triesters in                   Occurrence of Contaminants of Emerging            62. Clara, M., M. Kralik, H. Miesbauer, M.
                                                         the Indoor Environment—an Inter-                        Concern Along the California Coast                     Schabuss, S. Scharf, B. Vallant, S. Weiss,
                                                         Laboratory Exposure Study. Indoor Air,                  (2009–10) Using Passive Sampling                       and B. Grillitsch (Environment Agency
                                                         11, 145–49.                                             Devices. Marine Pollution Bulletin,                    Austria). 2010. Pollutants of Priority
                                                    39. Makinen, M.S.E., M.R.A. Makinen, J.T.B.                  81(2), 347–354.                                        Concern in Austrian Rivers Mercury and
                                                         Koistinen, A.L. Pasanen, P.O. Pasanen,             51. Hoppe-Jones, C., G. Oldham, and J.E.                    Its Compounds Trisphosphates. REP–
                                                         P.J. Kalliokoski, and A.M. Korpi. 2009.                 Drewes. 2010. Attenuation of Total                     0253. Vienna, Austria.
                                                         Respiratory and Dermal Exposure to                      Organic Carbon and Unregulated Trace              63. Cristale, J., A. Katsoyiannis, C. Chen, K.C.
                                                         Organophosphorus Flame Retardants                       Organic Chemicals in U.S. Riverbank                    Jones, and S. Lacorte. 2013a. Assessment
                                                         and Tetrabromobisphenol a at Five Work                  Filtration Systems. Water Research,                    of Flame Retardants in River Water
                                                         Environments. Environmental Science &                   44(15), 4643–4659.                                     Using a Ceramic Dosimeter Passive
                                                         Technology, 43(3), 941–947.                        52. Kolpin, D.W., E.T. Furlong, M.T. Meyer,                 Sampler. Environmental Pollution, 172,
mstockstill on DSK30JT082PROD with PROPOSALS




                                                    40. Marklund, A., B. Andersson, and P.                       E.M. Thurman, S.D. Zaugg, L.B. Barber,                 163–169.
                                                         Haglund. 2005. Traffic as a Source of                   and H.T. Buxton. 2002. Pharmaceuticals,           64. Cristale, J., A. Katsoyiannis, A.J.
                                                         Organophosphorus Flame Retardants                       Hormones, and Other Organic                            Sweetman, K.C. Jones, and S. Lacorte.
                                                         and Plasticizers in Snow. Environmental                 Wastewater Contaminants in U.S.                        2013b. Occurrence and Risk Assessment
                                                         Science & Technology, 39(10), 3555–                     Streams, 1999–2000: A National                         of Organophosphorus and Brominated
                                                         3562.                                                   Reconnaissance. Environmental Science                  Flame Retardants in the River Aire (Uk).
                                                    41. Sanchez, C., M. Ericsson, H. Carlsson,                   & Technology, 36(6), 1202–1211.                        Environmental Pollution, 179, 194–200.
                                                         and A. Colmsjo. 2003. Determination of             53. Oros, D.R., W.M. Jarman, T. Lowe, N.               65. Fries, E., and W. Puttmann. 2003.
                                                         Organophosphate Esters in Air Samples                   David, S. Lowe, and J.A. Davis. 2003.                  Monitoring of the Three



                                               VerDate Sep<11>2014   16:50 Apr 11, 2017   Jkt 241001   PO 00000   Frm 00017   Fmt 4702   Sfmt 4702   E:\FR\FM\12APP1.SGM   12APP1


                                                                           Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Proposed Rules                                              17611

                                                         Organophosphate Esters Tbp, TCEP and               77. Yoon, Y., J. Ryu, J. Oh, B.G. Choi, and                 Absorption of Flame Retardant
                                                         Tbep in River Water and Ground Water                    S.A. Snyder. 2010. Occurrence of                       Chemicals. Food Chem Toxicol.
                                                         (Oder, Germany). Journal of                             Endocrine Disrupting Compounds,                        39:1263–1270.
                                                         Environmental Monitoring, 5(2), 346–                    Pharmaceuticals, and Personal Care                92. Marzulli F.N., Callahan B.S., Brown
                                                         352.                                                    Products in the Han River (Seoul, South                D.W.C. 1965. Chemical Structure and
                                                    66. Garcia-Lopez, M., I. Rodriguez, and R.                   Korea). Science of The Total                           Skin Penetrating Capacity of a Short
                                                         Cela. 2010. Mixed-Mode Solid-Phase                      Environment, 408(3), 636–643.                          Series of Organic Phosphates and
                                                         Extraction Followed by Liquid                      78. Chen, D., R. Letcher, N. Burgess, L.                    Phosphoric Acid. J Invest Derm.
                                                         Chromatography-Tandem Mass                              Champoux, J. Elliott, C. Hebert, P.                    44(5):339–344.
                                                         Spectrometry for the Determination of                   Martin, M. Wayland, D. Weseloh, and L.            93. Minegashi K–I, Kurebayashi H., Seiichi,
                                                         Tri- and Di-Substituted                                 Wilson. 2012. Flame Retardants in Eggs                 Namaru, Morimot K, Takahashi T,
                                                         Organophosphorus Species in Water                       of Four Gull Species (Laridae) from                    Yamaha T. 1988. Comparative Studies on
                                                         Samples. Journal of Chromatography. A,                  Breeding Sites Spanning Atlantic to                    Absorption, Distribution, and Excretion
                                                         1217(9), 1476–1484.                                     Pacific Canada. Environmental Pollution,               of Flame Retardants Halogenated Alkyl
                                                    67. Kim, S.D., J. Cho, I.S. Kim, B.J.                        168, 1–9.                                              Phosphate in Rats. Eisei Kagaku
                                                         Vanderford, and S.A. Snyder. 2007.                 79. EPA. Response to Petition to Order                      34(2):102–114.
                                                         Occurrence and Removal of                               Testing of the Chlorinated Phosphate              94. Nomeir A.A., Kato D., Matthews H.B.
                                                         Pharmaceuticals and Endocrine                           Ester (CPE) Cluster Under Section 4(a) of              1981. The Metabolism and Disposition of
                                                         Disruptors in South Korean Surface,                     the Toxic Substances Control Act. 2017.                Tris(1,3-dichloro-2-propyl)phosphate
                                                         Drinking, and Waste Waters. Water                  80. EPA. Assessments for TSCA Work Plan                     (Fryol FR–2) in the Rat. Toxicol Appl
                                                         Research, 41(5), 1013–1021.                             Chemicals. https://www.epa.gov/                        Pharm. 57:401–413.
                                                    68. Martinez-Carballo, E., C. Gonzalez-                      assessing-and-managing-chemicals-                 95. Pawar G. Abdallah A–E, Villaverde de
                                                         Barreiro, A. Sitka, S. Scharf, and O.                   under-tsca/assessments-tsca-work-plan-                 Saa E., Harrad S. 2017. Dermal
                                                         Gans. 2007. Determination of Selected                   chemicals. (retrieved on March 15,                     Bioaccessibility of Flame Retadants from
                                                         Organophosphate Esters in the Aquatic                   2017).                                                 Indoor Dust and the Influence of
                                                         Environment of Austria. Science of The             81. EPA. Docket EPA–HQ–OPPT–2015–0068.                      Topically Applied Cosmetics. J Exp Scie
                                                         Total Environment, 388(1–3), 290–299.                   2016. https://www.regulations.gov/                     Environ Epid. 27:100–105.
                                                    69. Matamoros, V., C.A. Arias, L.X. Nguyen,                  docket?D=EPA-HQ-OPPT-2015-0068.                   96. EU (European Union). 2008a. European
                                                         V. Salvado, and H. Brix. 2012.                     82. EPA. Procedures for Chemical Risk                       Union Risk Assessment Report: Tris(2-
                                                         Occurrence and Behavior of Emerging                     Evaluation under the Amended Toxic                     Chloro-1-Methylethyl) Phosphate (TCPP)
                                                         Contaminants in Surface Water and a                     Substances Control Act; Proposed Rule.                 CAS No: 13674–84–5. Ireland and
                                                         Restored Wetland. Chemosphere, 88(9),                                                                          United Kingdom, Luxembourg. http://
                                                                                                                 Federal Register (82 FR 7565, January
                                                         1083–1089.                                                                                                     echa.europa.eu/documents/10162/
                                                                                                                 19, 2017) (FRL–9957–75). https://
                                                    70. Quednow, K., and W. Puttmann. 2009.                                                                             6434698/orats_final_rar_tris2-chloro-1-
                                                                                                                 www.regulations.gov/document?D=EPA-
                                                         Temporal Concentration Changes of                                                                              methylethylphos_en.pdf.
                                                                                                                 HQ-OPPT-2016-0654-0001.
                                                         Deet, TCEP, Terbutryn, and                                                                                97. EU (European Union). 2008b. European
                                                                                                            83. EPA. Procedures for Prioritization of                   Union Risk Assessment Report: Tris[2-
                                                         Nonylphenols in Freshwater Streams of
                                                                                                                 Chemicals for Risk Evaluation under                    Chloro-1-(Chloromethyl)Ethyl]
                                                         Hesse, Germany: Possible Influence of
                                                                                                                 Toxic Substances Control Act; Proposed                 Phosphate (TDCP) CAS No: 13674–87–8.
                                                         Mandatory Regulations and Voluntary
                                                         Environmental Agreements.                               Rule. Federal Register (82 FR 4826,                    Ireland and United Kingdom,
                                                         Environmental Science and Pollution                     January 17, 2017) (FRL–9957–74).                       Luxembourg. http://echa.europa.eu/
                                                         Research, 16(6), 630–640.                               https://www.regulations.gov/document                   documents/10162/6434698/orats_final_
                                                    71. Quednow, K., and W. Puttmann. 2008.                      ?D=EPA-HQ-OPPT-2016-0636-0001.                         rar_tris2-chloro-1-chloromethyleth_
                                                         Organophosphates and Synthetic Musk                84. OECD. 2010. Test No 417: Toxicokinetics.                en.pdf.
                                                         Fragrances in Freshwater Streams in                     Guideline for the testing of chemicals.           98. EPA. 1998b. Acute Inhalation Toxicity
                                                         Hessen/Germany. CLEAN—Soil, Air,                        OECD Guidelines for the Testing of                     (OPPTS Test Guideline 870.1300).
                                                         Water, 36(1), 70–77.                                    Chemicals, Section 4: Health Effects.             99. Smyth H.F., Carpenter C.P. and Weil C.S.
                                                    72. Regnery, J., and W. Puttmann. 2010.                      OECD Publishing, Paris.                                1951. Range-finding toxicity data: List
                                                         Occurrence and Fate of                             85. OECD. 2004. Test No. 427: Skin                          IV. Arch. Ind. Hyg. Occup. Med., 4, 119–
                                                         Organophosphorus Flame Retardants                       Absorption: In Vivo Method. OECD                       122.
                                                         and Plasticizers in Urban and Remote                    Guidelines for the Testing of Chemicals,          100. Environmental Affairs and Toxicology
                                                         Surface Waters in Germany. Water                        Section 4: Health Effects. OECD                        Department. 1981. Four hour acute
                                                         Research, 44(14), 4097–4104.                            Publishing, Paris.                                     inhalation toxicity study in Sprague-
                                                    73. Rodil, R., J.B. Quintana, E. Concha-Grana,          86. EPA. 1998a. Acute Dermal Toxicity                       Dawley rats with 2425–80 (Unpublished
                                                         P. Lopez-Mahia, S. Muniategui-Lorenzo,                  (OPPTS Test Guideline 870.1200).                       report).
                                                         and D. Prada-Rodriguez. 2012. Emerging             87. Lynn, R.K.; Wong, C; Garvie-Gould,                 101. Klassen, C.D. 2008. Editor: Cassarett and
                                                         Pollutants in Sewage, Surface and                       Kennish J.M. 1981 Disposition of the                   Doull’s Toxicology: The Basic Science of
                                                         Drinking Water in Galicia (Nw Spain).                   Flame Retardant, Tris(1.3-dichloro-2-                  Poisons. Seventh Edition. McGraw-Hill
                                                         Chemosphere, 86(10), 1040–1049.                         propyl)phosphate, in the Rat. Drug                     Medical Publishing Division. New York.
                                                    74. Schwarzbauer, J., and S. Heim. 2005.                     Metab. Disp. 9(5):434–441.                        102. NTP (National Toxicology Program). n.d.
                                                         Lipophilic Organic Contaminants in the             88. Burka L.T., Sanders J.M., Herr D.W.,                    Modified One-Generation Studies.
                                                         Rhine River, Germany. Water Research,                   Matthews H.B. 1991. Metabolism of                      https://ntp.niehs.nih.gov/testing/types/
                                                         39(19), 4735–4748.                                      Tris(2-chloroethyl)phosphate in Rats and               mog/index.html (retrieved in 2016).
                                                    75. Stepien, D.K., J. Regnery, C. Merz, and W.               Mice. Drug Metab Disp. 19(2):443–447.             103. EPA. 1998c. Reproduction and fertility
                                                         Puttmann. 2013. Behavior of                        89. Fang M., Stapleton H.M. 2014. Evaluating                effects (OPPTS Test Guideline 870.3800).
                                                         Organophosphates and Hydrophilic                        the Bioaccessibility of Flame Retardants          104. OECD. 2001.Test No 416: Two-
                                                         Ethers During Bank Filtration and Their                 in House Dust Using an In Vitro Tenax                  Generation Reproduction Toxicity.
                                                         Potential Application as Organic Tracers.               Bead Assisted Sorptive Physiologically                 OECD Guidelines for the Testing of
mstockstill on DSK30JT082PROD with PROPOSALS




                                                         A Field Study from the Oderbruch,                       Based Method. Environmental Science &                  Chemicals, Section 4: Health Effects.
                                                         Germany. Science of The Total                           Technology. 48:13323–13330.                            OECD Publishing, Paris.
                                                         Environment, 458–460, 150–159.                     90. Herr D.W., Sanders J.M., Matthews H.B.             105. NTP (National Toxicology Program).
                                                    76. Weigel, S., K. Bester, and H. Huhnerfuss.                1991. Brain Distribution and Fate of                   1991b. Final Report on the Reproductive
                                                         2005. Identification and Quantification                 Tris(2-chloroethyl)phosphate in Fischer                Toxicity of Tris (2-chloroethyl)
                                                         of Pesticides, Industrial Chemicals, and                344 Rats. Drug Metab Disp. 19(2):436–                  phosphate (CAS No. 115–96–8) in CD–1
                                                         Organobromine Compounds of Medium                       442.                                                   Swiss Mice. RACB9204.
                                                         to High Polarity in the North Sea. Marine          91. Hughes M.F., Edwards B.C., Mitchell                106. TNO Quality of Life. 2007. Oral two-
                                                         Pollution Bulletin, 50(3), 252–263.                     C..T, Bhooshan B. 2001. In Vitro Dermal                generation reproduction toxicity study



                                               VerDate Sep<11>2014   16:50 Apr 11, 2017   Jkt 241001   PO 00000   Frm 00018   Fmt 4702   Sfmt 4702   E:\FR\FM\12APP1.SGM   12APP1


                                                    17612                  Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Proposed Rules

                                                        (including a dose range finding study)                  Potential estrogenic effects of                        Polychlorinated, Polybrominated And
                                                        with Tris(2-chloro-1-methylethyl)-                      phosphorus-containing flame retardants.                Brominated/Chlorinated Dibenzo-p-
                                                        phosphate in rats. (Unpublished report).                Environmental Science & Technology.                    Dioxins And Dibenzofurans In Ambient
                                                    107. Tanaka S., Nakaura S., Kawashima K.,                   48(12):6995–7001.                                      Air. 1999. https://www3.epa.gov/
                                                        Nagao S., Endo T., Onoda K., Kasuya Y.              118. EPA. 2015. Larval amphibian growth                    ttnamti1/files/ambient/airtox/to-
                                                        and Omori Y. 1981. Effect of oral                       and development assay (LAGDA)                          9arr.pdf.
                                                        administration of tris(1,3-                             (OCSPP Test Guideline 890.2300).                   130. Bradman, A., Castorina, R., Gaspar, F.,
                                                        dichloroisopropyl) phosphate to                     119. Zaugg, S.D., Smith, S.G., Schroeder,                  Nishioka, M., Colon, M., Weathers, W.,
                                                        pregnant rats on prenatal and post natal                M.P., Barber, L.B., Burkhardt, M.R. 2002.              Egeghy, P.P., Maddalena, R., Williams, J.,
                                                        developments. Eisei Shikenjo Hokoku                     Methods of Analysis by the U.S.                        Jenkins, P.L., McKone, T.E. 2014. Flame
                                                        99, 50–55. (in Japanese).                               Geological Survey National Water                       Retardant Exposures in California Early
                                                    108. Stauffer Chemical Company. 1981b.                      Quality Laboratory—Determination of                    Childhood Education Environments.
                                                        Toxicology reports on FYROL FR–2                        Wastewater Compounds by                                Chemosphere (116).
                                                        (volume I–II) with attachments and cover                Polystyrene—Divinylbenzene Solid-                  131. Wei, G.-L., Li, D.-Q., Zhuo, M.-N., Liao,
                                                        letters dated 020381. Submitted to the                  Phase Extraction and Capillary-Column                  Y.-S., Xie, Z.-Y., Guo, T.-L., Li, J.-J,
                                                        U.S. Environmental Protection Agency                    Gas Chromatography/Mass                                Zhang, S.-Y., Liang, Z.-Q. 2015.
                                                        under TSCA Section 8E. EPA88–                           Spectrometry, Water-Resources                          Organophosphorus Flame Retardants
                                                        8100271. OTS0204911.                                    Investigations Report 01–4186. U.S.                    and Plasticizers: Sources, Occurrence,
                                                    109. NTP, (National Toxicology Program).                    Department of the Interior.                            Toxicity and Human Exposure. Environ.
                                                        n.d. Testing Status of                              120. Rodil, R., Quintana, J.B., Reemtsma, T.               Poll. (196).
                                                        Tris(Chloropropyl)phosphate—M20263.                     2005. Liquid Chromatography—Tandem                 132. Bester, K. 2005. Comparison of TCPP
                                                        https://ntp.niehs.nih.gov/testing/status/               Mass Spectrometry Determination of                     concentrations in sludge and wastewater
                                                        agents/ts-m20263.html (retrieved in                     Nonionic Organophosphorus Flame                        in a typical German sewage treatment
                                                        2017).                                                  Retardants and Plasticizers in                         plant—comparison of sewage sludge
                                                    110. Chen G., Jin Y., Wu Y., Liu L., Fu Z.                  Wastewater Samples, Anal. Chem. (77).                  from 20 plants. 7: 509–513.
                                                        2015. Exposure of male mice to two                  121. Unites States Geological Survey (USGS).           133. Olofsson, U., Bignert, A., Haglund, P.
                                                        kinds of organophosphate flame                          National Water Information System.                     2012. Time-trends of metals and organic
                                                        retardants (OPFRs) induced oxidative                    https://waterdata.usgs.gov/nwis                        contaminants in sewage sludge. Water
                                                        stress and endocrine disruption. Environ                (Retrieved on March 21, 2017).                         research 46: 4841–4851. http://
                                                        Toxicol Pharmacol. 40:310–318                       122. Glassmeyer, S.T., Furlong, E.T., Kolpin,              www.ncbi.nlm.nih.gov/pubmed/
                                                    111. Farhat A., Crump D., Chiu S., Williams                 D.W., Cahill, J.D., Zaugg, S.D., Werner,               22763293.
                                                        K.L., Letcher R.J., Gauthier L.T.,                      S.L., Meyer, M.T., Kryak, D.D. 2005.               134. Fries, E., Mihajlovic, I. 2011. Pollution
                                                        Kennedy S.W. 2013. In Ovo effects of                    Transport of Chemical and Microbial                    of Soils with Organophosphorus Flame
                                                        two organophosphate flame retardants—                   Compounds from Known Wastewater                        Retardants and Plasticizers. J. Environ.
                                                        TCPP and TDCPP—on pipping success,                      Discharges: Potential for Use as                       Monit. (13).
                                                        development, mRNA expression, and                       Indicators of Human Fecal                          135. Klosterhaus, S.L., Stapleton, H.M.,
                                                        thyroid hormone levels in chicken                       Contamination, Environmental Science &                 LaGuardia, M.J., Greig, D.J. 2012.
                                                        embryos. Tox Sci 134(1):92–102.                         Technology. (39).                                      Brominated and Chlorinated Flame
                                                    112. Kojima H., Takeuchi S., Itoh T., Iida M.,          123. Jackson, J., Sutton, R. 2008 Sources of               Retardants in San Francisco Bay
                                                        Kobayashi S., Yoshida T. 2013. In vitro                 Endocrine-Disrupting Chemicals in                      Sediments and Wildlife. Environ. Intl.
                                                        endocrine disruption potential of                       Urban Wastewater, Oakland, CA Sci. Tot.                (47).
                                                        organophosphate flame retardants via                    Environ. (405).                                    136. Regnery, J., Puttmann, W., Merz, C.,
                                                        human nuclear receptors. Toxicology.                124. O’Brien, J.W., Thai, P.K., Brandsma,                  Berthold, G., 2011. Occurrence and
                                                        14(1):76–83.                                            S.H., Leonards, P.E.G., Ort, C., Mueller,              distribution of organophosphorus flame
                                                    113. Wang Q., Lai N.L., Wang X., Guo Y.,                    J.F. 2015. Wastewater analysis of Census               retardants and plasticizers in
                                                        Lam P.K., Lam J.C., Zhou B. 2015a.                      Day Samples to Investigate per Capita                  anthropogenically affected groundwater.
                                                        Bioconcentration and transfer of the                    Input of Organophosphorus Flame                        J. Environ. Monit. 13, 347–354.
                                                        organophorous flame retardant 1,3-                      Retardants and Plasticizers into                   137. Stackelberg, P.E., Furlong, E.T., Meyer,
                                                        dichloro-2-propyl phosphate causes                      Wastewater. Chemosphere (138).                         M.T., Zaugg, S.D., Henderson, A.K.,
                                                        thyroid endocrine disruption and                    125. Schreder, E.D. and La Guardia, M.J. 2014              Reissman, D.B. 2004. Persistence of
                                                        developmental neurotoxicity in zebrafish                Flame Retardant Trnsfers from U.S.                     pharmaceutical compounds and other
                                                        larvae. Environmental Science &                         Households (Dust and Laundry                           organic wastewater contaminants in a
                                                        Technology. 49(8):5123–32.                              Wastewater) to the Aquatic Environment,                conventional drinking-water-treatment
                                                    114. Wang Q., Lam J.C., Han J., Wang X., Guo                Environmental Science & Technology 48,                 plant. Sci. Tot. Environ. 329, 99–113.
                                                        Y., Lam P.K., Zhou B. 2015b.                            11575–11583.                                       138. NIOSH. Assessment of Occupational
                                                        Developmental exposure to the                       126. EPA. ChemSTEER-chemical screening                     Exposure to Flame Retardants. 2014.
                                                        organophosphorus flame retardant                        tool for exposures and environmental                   https://ntp.niehs.nih.gov/ntp/about_ntp/
                                                        tris(1,3-dichloro-2-propyl) phosphate:                  releases. 2017. https://www.epa.gov/tsca-              bsc/2014/dec/nioshupdate_508.pdf.
                                                        Estrogenic activity, endocrine disruption               screening-tools/chemsteer-chemical-                139. OSHA. OSHA Technical Manual (OTM),
                                                        and reproductive effects on zebrafish.                  screening-tool-exposures-and-                          OSHA Instruction TED 01–00–015 [TED
                                                        Aquatic Toxicol. 160:163–171.                           environmental-releases.                                1–0.15A]. https://www.osha.gov/dts/
                                                    115. Wang Q., Liang K., Liu J., Yang L., Guo            127. EPA. E–FAST-exposure and fate                         osta/otm/otm_ii/otm_ii_2.html.
                                                        Y., Liu C., Zhou B. 2015c. Exposure of                  assessment screening tool version 2014.            140. Gorman Ng, M., Semple, S., Cherrie,
                                                        zebrafish embryos/larvae to TDCPP alters                2017. https://www.epa.gov/tsca-                        J.W., Christopher, Y., Northage, C.,
                                                        concentrations of thyroid hormones and                  screening-tools/e-fast-exposure-and-fate-              Tielemans, E., Veroughstraete, V. and
                                                        transcriptions of genes involved in the                 assessment-screening-tool-version-2014.                Von Tongeren, M. 2012. The relationship
                                                        hypothalamic-pituitary-thyroid axis.                128. EPA. AERMOD. Technology Transfer                      between inadvertent ingestion and
mstockstill on DSK30JT082PROD with PROPOSALS




                                                        Aquatic Toxicol. 126:207–213.                           Network Support Center for Regulatory                  dermal exposure pathways: A new
                                                    116. Xu T., Wang Q., Shi Q., Fang Q., Guo                   Atmospheric Modeling, Meteorological                   integrated conceptual model and a
                                                        Y., Zhou B. 2015. Bioconcentration,                     Processors and Accessory Programs. Air                 database of dermal and oral transfer
                                                        metabolism and alterations of thyroid                   dispersion software. 2016. https://                    efficiencies. Annals of Occupational
                                                        hormones of Tris(1,3-dichloro-2-propyl)                 www3.epa.gov/ttn/scram/dispersion_                     Hygiene. 56, 9 (1000–1012).
                                                        phosphate (TDCPP) in Zebrafish. 81–586.                 prefrec.htm#aermod.                                141. Mäkinen, M.S., Mäkinen, M.R.,
                                                        Environ Toxicol. Pharm. 40(2):5.                    129. EPA. Office of Research and                           Koistinen, J.T., Pasanen, A.L., Pasanen,
                                                    117. Zhang Q., Lu M., Dong X., Wang C.,                     Development. Compendium Method                         P.O., Kalliokoski, P.J., & Korpi, A.M.
                                                        Zhang C., Liu W., Zhao M. 2014.                         TO–9A: Determination Of                                2009. Respiratory and dermal exposure



                                               VerDate Sep<11>2014   16:50 Apr 11, 2017   Jkt 241001   PO 00000   Frm 00019   Fmt 4702   Sfmt 4702   E:\FR\FM\12APP1.SGM   12APP1


                                                                           Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Proposed Rules                                           17613

                                                        to organophosphorus flame retardants                153. Wetton P.M. 1996. Acute toxicity to               FEDERAL COMMUNICATIONS
                                                        and tetrabromobisphenol A at five work                  earthworms. Report of SPL Project                  COMMISSION
                                                        environments. Environmental Science &                   Number: 071/458. SafePharm
                                                        Technology, 43(3), 941–947. https://                    Laboratories Ltd., Derby. as cited in EU           47 CFR Part 64
                                                        doi.org/10.1021/es802593t.                              (European Union), 2008a (Ref. 96) and
                                                    142. Washington State Department of                                                                            [CG Docket Nos. 10–51 and 03–123; FCC
                                                                                                                EU (European Union), 2008b (Ref. 97).              17–26]
                                                        Ecology. 2014. Flame Retardants in
                                                        General Consumer and Children’s                     154. Servajean E. 2003a. Laboratory
                                                        Products. (Publication No. 14–04–021).                  determination of the long-term toxicity            Structure and Practices of the Video
                                                        Washington State Department of                          of TCPP to earthworms (Eisenia fetida)             Relay Services Program
                                                        Ecology: Olympia, WA. https://                          using artificial soil substrate. Report of
                                                        fortress.wa.gov/ecy/publications/                       Phytosafe Study Number: 03–69–005–                 AGENCY:  Federal Communications
                                                        documents/1404021.pdf.                                  ES. PHYTOSAFE s.a.r.l., 2, rue Marx                Commission.
                                                    143. Miller, G.Z. & Gearhart, J. 2016.                      Dormoy, 64000 Pau, France. as cited in             ACTION: Proposed rule.
                                                        Traveling with Toxics: Flame Retardants                 EU (European Union), 2008a (Ref. 96).
                                                        & Other Chemicals in Children’s Car                 155. Van Ginkel C.G. 2005b. Toxicity of                SUMMARY:   In this document, the
                                                        Seats. Ecology Center: Ann Arbor, MI.                                                                      Commission seeks comment on
                                                                                                                TDCP to soil micro-organisms: Nitrogen
                                                        http://www.ecocenter.org/healthy-stuff/                                                                    establishing performance goals and
                                                        pages/childrens-car-seat-study-2016-                    transformation inhibition test. Akzo
                                                                                                                Nobel Research and Technology                      service quality metrics to evaluate the
                                                        report.                                                                                                    efficacy of the video relay service (VRS)
                                                    144. EPA. 2012a. Avian Acute Oral Toxicity                  Chemicals Arnhem. Report number CER
                                                        Test (OCSPP Test Guideline 850.2100).                   F05047 T 05015 NTI, 20th October 2005.             program and on the incidence of
                                                    145. Fernie K., Palace V., Peters L., Basu Nil,             as cited in EU (European Union), 2008b             ‘‘phony’’ VRS calls and the handling of
                                                        Letcher R., Karouna-Renier N., Schultz                  (Ref. 97).                                         such calls. The Commission also
                                                        S., Lazarus R. and Rattner B. 2015.                 156. EPA. 2012d. Early Seedling Growth                 proposes a four-year plan for VRS
                                                        Investigating Endocrine and                             Toxicity Test (OCSPP Test Guideline                compensation and rule amendments to
                                                        Physiological Parameters of Captive                     850.4230).                                         permit server-based routing of VRS and
                                                        American Kestrels Exposed by Diet to                                                                       point-to-point video calls, provide
                                                                                                            157. Servajean E. 2004b. Laboratory
                                                        Selected Organophosphate Flame                                                                             safeguards regarding who may use VRS
                                                                                                                assessment of the side-effects of TDCP on
                                                        Retardants; Environmental Science &                                                                        at enterprise and public videophones,
                                                        Technology, vol. 49, issue 12, pp. 7448–                plant growth. Study Number: 04–99–
                                                                                                                022–ES. PHYTOSAFE s.a.r.l. Pau,                    allow customer service support centers
                                                        7455.
                                                    146. EPA. 2012b. Avian Dietary Toxicity Test                France. as cited in EU (European Union),           to access the Telecommunications Relay
                                                        (OCSPP Test Guideline 850.2200).                        2008b (Ref. 97).                                   Service (TRS) Numbering Directory for
                                                    147. Sprague G.L., Sandvik L.L., Brookins-              158. Römbke, J. Bauer, C. Brodesser, J.               direct video calling, and make a
                                                        Hendricks M.J. and Bickford A.A. 1981.                  Brodsky, J. Danneberg, G. Heimann, D.              technical change to per-call validation
                                                        Neurotoxicity of two organophosphorus                   Renner, I. and Schallnass, H.J. 1995.              requirements. The Commission also
                                                        ester flame retardants in hens. J. Toxicol.             Basis for the assessment of the                    seeks comment on whether to continue
                                                        Environ. Health, 8, 507–518.                            ecotoxicological potential of ‘‘existing           including research and development in
                                                    148. EU (European Union). 2009. European                    chemicals’’ in the terrestrial                     the TRS Fund budget, prohibit non-
                                                        Union Risk Assessment Report: Tris (2-                                                                     service related inducements to register
                                                                                                                environment—development of a testing
                                                        Chloroethyl) Phosphate, (TCEP) CAS No:
                                                                                                                strategy. Batelle Eur. Res. rept. 106 04           for VRS, and prohibit the use of non-
                                                        115–96–8. Ireland and United Kingdom,
                                                        Luxembourg. http://echa.europa.eu/                      103 (UBA), UBA-Texte 53/95 (in                     compete provisions in VRS
                                                        documents/10162/6434698/orats_final_                    German), as cited in EU (European                  communications assistant (CA)
                                                        rar_tris2-chloroethylphosphate_en.pdf.                  Union), 2009 (Ref. 148).                           employment contracts.
                                                    149. EPA. 2012c. Earthworm Subchronic                   159. Servajean E. 2003b. Laboratory                    DATES: For VRS compensation rates,
                                                        Toxicity Test (OCSPP Test Guideline                     assessment of the side-effects of TCPP on          server-based routing, and research and
                                                        850.3100).                                              plant growth. Report of Phytosafe Study            development, comments are due April
                                                    150. Wildlife International, Ltd. 2006a.                    Number: 03–69–012–ES. PHYTOSAFE                    24, 2017, and reply comments are due
                                                        Tris[2-chloro-1-(chloromethyl)ethyl]-                   s.a.r.l., 2, rue Marx Dormoy, 64000 Pau,
                                                        phosphate (TDCP): A 28-Day Sediment
                                                                                                                                                                   May 4, 2017. For performance goals and
                                                                                                                France. as cited in EU (European Union),           service quality metrics, the incidence
                                                        Toxicity Test with Chironomus riparius
                                                                                                                2008a (Ref. 96).                                   and handling of ‘‘phony’’ VRS calls,
                                                        Using Spiked Sediment. Final Report
                                                        Project Number: 583A–104. Wildlife                                                                         VRS use of enterprise and public
                                                        International, Ltd., Easton, Maryland               List of Subjects in 40 CFR Chapter I                   videophones, direct video calling
                                                        21601, U.S.A., as cited in EU (European                                                                    customer support services, per-call
                                                        Union), 2008b. (REF 106)                              Environmental protection, Flame
                                                                                                                                                                   validation procedures, non-service
                                                    151. Wildlife International, Ltd. 2006b.                retardants, Hazardous substances,
                                                                                                                                                                   related inducements, and non-compete
                                                        Tris[2-chloro-1-(chloromethyl)ethyl]-               chlorinated phosphate ester cluster.                   provisions in VRS employment
                                                        phosphate (TDCP): A Prolonged
                                                        Sediment Toxicity Test with Hyalella
                                                                                                              Dated: April 6, 2017.                                contracts, comments are due May 30,
                                                        azteca Using Spiked Sediment. Final                 Wendy Cleland-Hamnett, Acting,                         2017, and reply comments are due June
                                                        Report Project Number: 583A–105.                    Assistant Administrator, Office of Chemical            26, 2017.
                                                        Wildlife International, Ltd., Easton,               Safety and Pollution Prevention.                       ADDRESSES: You may submit comments,
                                                        Maryland 21601, U.S.A., as cited in EU              [FR Doc. 2017–07404 Filed 4–11–17; 8:45 am]            identified by CG Docket Nos. 10–51 and
                                                        (European Union), 2008b. (Ref. 97)                                                                         03–123, by any of the following
mstockstill on DSK30JT082PROD with PROPOSALS




                                                                                                            BILLING CODE 6560–50–P
                                                    152. Wildlife International, Ltd. 2006c.                                                                       methods:
                                                        Tris[2-chloro-1-(chloromethyl)ethyl]-                                                                         • Electronic Filers: Comments may be
                                                        phosphate (TDCP): A Prolonged
                                                                                                                                                                   filed electronically using the Internet by
                                                        Sediment Toxicity Test with
                                                        Lumbriculus variegatus using Spiked                                                                        accessing the Commission’s Electronic
                                                        Sediment. Final Report Project Number:                                                                     Comment Filing System (ECFS), through
                                                        583A–106. Wildlife International, Ltd.,                                                                    the Commission’s Web site http://
                                                        Easton, Maryland 21601, U.S.A., as cited                                                                   apps.fcc.gov/ecfs/. Filers should follow
                                                        in EU (European Union), 2008b. (Ref. 97)                                                                   the instructions provided on the Web


                                               VerDate Sep<11>2014   16:50 Apr 11, 2017   Jkt 241001   PO 00000   Frm 00020   Fmt 4702   Sfmt 4702   E:\FR\FM\12APP1.SGM   12APP1



Document Created: 2017-04-12 00:23:14
Document Modified: 2017-04-12 00:23:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionPetition; reasons for Agency response.
DatesEPA's response to this TSCA section 21 petition was signed April 6, 2017.
ContactFor 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
FR Citation82 FR 17601 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR