[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Proposed Rules]
[Pages 14171-14184]
[FR Doc No: 2017-05291]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2016-0770; FRL-9960-09]

Tetrabromobisphenol A (TBBPA); TSCA Section 21 Petition; Reasons
for Agency Response

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition; reasons for Agency response.

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SUMMARY: This document provides the reasons for EPA's response to a
petition it received under the Toxic Substances Control Act (TSCA). The
TSCA section 21 petition was received from Earthjustice, Natural
Resources Defense Council, Toxic-Free Future, Safer Chemicals, Healthy
Families, BlueGreen Alliance, and Environmental Health Strategy Center
on December 13, 2016. The petitioners requested that EPA issue an order
under TSCA section 4, requiring that testing be conducted by
manufacturers (which includes importers) and processors on
tetrabromobisphenol A (``TBBPA'') (CAS No. 79-94-7). 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 March
10, 2017.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Virginia Lee, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to those persons who are or may manufacture
(which includes import) or process the chemical tetrabromobisphenol A
(``TBBPA'') (CAS No. 79-94-7). 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-2016-0770, 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<PHONE_NUMBER>. 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 rulemaking in the event of a lawsuit filed by the
petitioner after denial of a TSCA section 21 petition. 15 U.S.C.
2620(b)(4)(B).
    2. Legal standard regarding TSCA section 4 rules. EPA must make
several findings in order to issue a rule or order to require testing
under TSCA section 4(a)(1)(A)(i). In all cases, EPA must find that
information and experience are insufficient to reasonably determine or
predict the effects of a chemical substance on health or the
environment and that testing of the chemical substance is necessary to
develop the missing information. 15 U.S.C. 2603(a)(1). In addition, EPA
must find that the chemical substance may present an unreasonable risk
of injury under section 4(a)(1)(A)(i). Id. If EPA denies a petition for
a TSCA section 4 rule or order and the petitioners challenge that
decision, TSCA section 21 allows a court to order EPA to initiate the
action requested by the petitioner if the petitioner demonstrates to
the satisfaction of the court by a preponderance of the evidence in a
de novo proceeding that findings very similar to those described in
this unit with respect to a chemical substance have been met.

III. Summary of the TSCA Section 21 Petition

A. What action was requested?

    On December 13, 2016, 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 (which includes importers) and processors on
tetrabromobisphenol A (``TBBPA'') (CAS No. 79-94-7) (Ref. 1).

B. What support do the petitioners offer?

    The petitioners state section 4(a)(1) of TSCA requires EPA to
direct testing on a chemical substance or mixture if it 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 TBBPA ``may present an unreasonable
risk of injury to health or the environment'' because there is
substantial evidence that TBBPA may be toxic, including conclusions
from:
     EPA's TSCA Work Plan Chemical Problem Formulation and
Initial Assessment (Ref. 2), which states TBBPA ``can be considered
hazardous to the environment'' and that ``there is some concern'' for
certain cancers and developmental effects.
     The International Agency for Research on Cancer (IARC) has
identified TBBPA as probably carcinogenic to humans (Ref. 3).
     Multiple in vitro and animal tests, where TBBPA has been
detected to cause endocrine effects, reproductive effects, neurological
effects, and immunological effects (Refs. 4-9).
    The petitioners also note that EPA, upon adding TBBPA in 1999 to
the Toxics Release Inventory (TRI) established under the Emergency
Planning and Community Right to Know Act, concluded that ``TBBPA is
toxic'' because ``[i]t has the potential to kill fish, daphnid, and
mysid shrimp, among other adverse effects, based on chemical and/or
biological interactions.'' 64 FR 58666, 58708. The petitioners assert
there is TBBPA exposure to humans and the environment based on the
following conclusions.
     TBBPA has the highest production volume of any brominated
flame retardant and is extensively used in consumer products, including
children's products (Ref. 2). The potential for widespread exposure is
extremely high.
     In 2012, TRI indicated that 127,845 pounds of TBBPA were
released into the environment (Ref. 2). Such releases indicate the
potential for widespread exposure in the population.
     The presence of TBBPA in people and the environment (biota
and environmental media) is established and affirmed in EPA's TBBPA
Problem Formulation and Initial Assessment (Ref. 2).
    With the evidence of toxicity and exposure and EPA's addition of
TBBPA to TRI (Ref. 10), the petitioners argue that TBBPA clearly meets
the TSCA section 4 criteria for ``may present an unreasonable risk of
injury to health or the environment.''
    The petitioners also assert there is ``insufficient information''
on TBBPA based on EPA's TBBPA Problem Formulation (Ref. 2), which
petitioners say cited lack of data for:
     Dermal and inhalation exposures, diet and drinking water
exposures, exposures to communities near facilities that manufacture
and process TBBPA, exposures to communities near facilities where ``e-
waste'' is disposed of and recycled, exposures to the workers in
manufacturing, processing, disposal and recycling facilities, and
exposures to degradation and combustion products.
     developmental, reproductive and neurological toxicity,
endocrine disruption, and genotoxic effects.
    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 TBBPA, and they
request EPA to not

commence the risk evaluation for TBBPA until data generated to comply
with the section 4 test order requested by the petitioners have been
received by EPA.

IV. Disposition of TSCA Section 21 Petition

A. What was EPA's response?

    After careful consideration, EPA has 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. 11), 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
TBBPA in August 2015 (Ref. 2). As stated on EPA's Web site titled
``Assessments for TSCA Work Plan Chemicals'' (Ref. 12), ``As a first
step in evaluating TSCA Work Plan Chemicals, EPA performs problem
formulation to determine if available data and current assessment
approaches and tools will support the assessments.'' During development
of the Problem Formulation and Initial Assessment document for TBBPA,
EPA followed an approach developed for assessing chemicals under TSCA
as it existed at that time.
    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 data and
presented them in the problem formulations, EPA did not necessarily
undertake a comprehensive search of available data 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 data
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 approach and
provide additional information/data to supplement or refine assessment
approach prior to EPA conducting detailed risk analysis and risk
characterization.'' (Ref. 12).
    EPA's 2015 Problem Formulation and Initial Assessment for TBBPA
does not constitute a full risk assessment for TBBPA, 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. 13). 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 TBBPA.
    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. 14). This interpretation, encompassing
``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 assessments.
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 TBBPA Problem
Formulation and Initial Assessment (Ref. 2).
    EPA agrees that the manufacture, distribution in commerce,
processing, use, or disposal of TBBPA 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 TBBPA, exposure pathways/
routes, or potentially exposed populations. However, the Problem
Formulation and Initial Assessment was not designed to be
comprehensive. Rather, the Problem Formulation and Initial Assessment
was developed under EPA's then-existing process, as explained
previously. It was a fit-for-purpose document to meet a TSCA Work Plan
(i.e., pre-Lautenberg Act) need. Going forward under TSCA, as amended,
EPA will conform its analyses to TSCA, as amended. EPA has explained
elsewhere how the Agency proposes to conduct prioritization and risk
evaluation going forward (Refs. 15 and 16). However, EPA does not find
that the petitioners have demonstrated, for each exposure pathway and
hazard endpoint presented in the petition, that the existing
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'' of TBBPA (or any combination of such activities) 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 for each requested test that
the information on the individual exposure pathways and hazard
endpoints identified by the petitioners does not demonstrate that there
is insufficient information upon which the effects of TBBPA 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 TBBPA. Therefore, the
toxicokinetics test (Organisation for Economic Co-operation (OECD) Test
Guideline 417) (Ref. 17) via the dermal route and the skin absorption:
In vivo test (OECD Test Guideline 427) (Ref. 18), requested by the
petitioners, are not needed. The information already available includes
oral toxicity studies and oral toxicokinetic studies identified in
EPA's Problem Formulation and Initial Assessment document (Ref. 2) and
the dermal toxicokinetics study identified by the petitioners (Ref.
19). These available studies are sufficient to reasonably determine the
internal doses of TBBPA for purposes of route-to-route (oral to dermal)
extrapolation. The 2016 Yu et al. study, cited in the petition (Ref.
1), characterizes absorption and elimination, while distribution and
metabolism characterization is available from studies using intravenous
dosing (Ref. 20). Furthermore, the available studies do not indicate
differential distribution, metabolism, and elimination specific to
skin. Therefore, the dermal toxicokinetics study requested by the
petitioners is not needed to inform or refine evaluation of dermal
exposures.
    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 TBBPA. Therefore, the toxicokinetics test (OECD Test
Guideline 417) (Ref. 17) via the inhalation route, requested by the
petitioners, is not needed. As described in EPA's Problem Formulation
and Initial Assessment (Ref. 2), EPA will use an alternative approach
to evaluate risks from inhalation exposure to TBBPA. Because TBBPA is a
solid, it may be reasonably predicted that particulates in the air are
the primary form of TBBPA that would be inhaled. TBBPA particles in air
that are inhaled are subsequently swallowed via the mucociliary
escalator (Ref. 21). Once the particles are in the gastrointestinal
tract, absorption can reasonably be assumed to be the same as in the
oral toxicity studies and hence, oral toxicity studies can be used for
risk assessment. Information is also available to estimate
bioaccessibility of TBBPA from dust using an extraction test with an in
vitro colon (Ref. 22). This additional information could also be
considered when evaluating risks from TBBPA via the oral route. This
approach would not require conducting the requested toxicokinetics test
(Ref. 17).
    Although a small percent of TBBPA particles may be in the
respirable range and may be absorbed directly through the lungs,
existing tests show that no systemic effects were observed in a 14-day
inhalation toxicity study (Ref. 23). Therefore, EPA considers that
assuming all inhaled particles are eventually swallowed and using
existing oral toxicity data should not underestimate effects from
inhaling TBBPA particles and therefore would reasonably predict such
effects.
    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).
    The petition does not set forth facts demonstrating that there is
insufficient information available to EPA to reasonably determine or
predict effects to the environment, specifically, toxicity to plants
exposed to TBBPA via the air. Therefore, the early seedling growth
toxicity test (OCSPP Test Guideline 850.4230) (Ref. 24), requested by
the petitioners, is not needed. As previously mentioned, because TBBPA
is a solid, it may be reasonably predicted that particulates in the air
are the primary form of TBBPA that would exist in air. Furthermore, as
stated on page 88 of EPA's Problem Formulation and Initial Assessment
document (Ref. 2), ``[u]ltimately air releases of TBBPA would be
expected to undergo deposition to terrestrial and aquatic environments
. . .'' and ``TBBPA tends to partition to soil and sediment . . .''.
These fate pathways for TBBPA are also shown in Figure 2-1 of EPA's
Problem Formulation and Initial Assessment document (Ref. 2). Hence,
exposure of plants to TBBPA is expected to occur primarily via soil and
sediments after deposition from air, which is why EPA excluded this
pathway from further assessment (Ref. 2, page 42), although EPA in the
Problem Formulation and Initial Assessment document mistakenly
mentioned plants in another sentence addressing ``[e]xposure via
directly inhaling [emphasis added] TBBPA,'' even though direct
inhalation is not applicable to plants and thereby may have caused
potential confusion to readers. If toxicity of TBBPA to plants were to
be included in an assessment, toxicity data following exposure via soil
and/or sediment exposures, not air, would be the scientifically
relevant data needed. To this end, as described in EPA's Problem
Formulation and Initial Assessment (Ref. 2), existing data and
information on phytotoxicity of TBBPA to six plant species is available
(Ref. 25). EPA's Problem Formulation and Initial Assessment document
(Ref. 2) included references for and a brief description of the
existing plant toxicity data (page 105). While assessment of soil-
dwelling organisms is included in EPA's Problem Formulation and Initial
Assessment document (Ref. 2), as depicted in Figure 2-1 and described
on page 40, EPA indicated that the environmental risk assessment for
the soil exposure pathway would be based on concentrations of concern
derived from data for soil invertebrates (Ref. 2; Figure 2-1; Table 2-
6; Page 40). Support for

EPA's selection of using species that are expected to be more sensitive
to potential effects of TBBPA in soil is provided in EPA's summary of
plant toxicity data, which states ``. . . TBBPA is two to three orders
of magnitude less toxic to terrestrial plants than to soil-dwelling
organisms'' (Ref. 2; Table_Apx F-2 and text on page 106).
    The petition does not set forth facts demonstrating that there is
insufficient information available to EPA to reasonably determine or
predict toxicity of TBBPA to avian species. Hence, inhalation
toxicokinetic studies (OECD Test Guideline 417) (Ref. 17) and the acute
inhalation toxicity study (OCSPP Test Guideline 870.1300) (Ref. 26)
modified for birds, requested by the petitioners, are not needed.
Although the Problem Formulation and Initial Assessment document
states, ``Exposure via directly inhaling TBBPA will not be assessed
because no information is available on the toxicity of
tetrabromobisphenol A to plants and other wildlife organisms (e.g.,
birds) exposed via the air.'' (Ref. 2; page 42), EPA's primary
rationale for not including further elaboration of inhalation risks to
avian species, as discussed in the Problem Formulation and Initial
Assessment document (Ref. 2; page 32 and Appendix F) is TBBPA's low
avian toxicity demonstrated in existing studies.
    Halldin et al., 2001 and Berg et al., 2001 (Refs. 27 and 28)
indicate no effects to egg-laying female quail nor embryos (except at
very high doses). The Halldin et al. (Ref. 27) study also included
toxicokinetic data indicating that TBBPA is rapidly metabolized and
excreted in birds (both embryos and egg-laying females). In these
studies, TBBPA was delivered by intravenous injection into females and
direct injection into eggs. This dosing regimen assures full (100%)
delivery of the dose into the animal, which does not occur in nature,
and thus provides the most sensitive means to detect the toxicity of
the TBBPA. Other routes of exposure (i.e., oral, inhalation, dermal)
result in incomplete absorption limiting the systematic availability of
TBBPA compared to the intravenous injection (i.e., less than 100%
delivered dose). Hence, intravenous toxicity test designs provide a
good understanding of the potential toxicity (or lack thereof) of a
chemical. In addition to the low avian toxicity of TBBPA, demonstrated
via intravenous injection, inhalation is not expected to be a
substantial exposure pathway to wildlife for TBBPA (Refs. 29 and 30).
The predominant route of exposure to terrestrial wildlife for a
chemical with physical-chemical properties (i.e., Log KOW =
5.90; water solubility = 4.16 mg/L) and partitioning parameters (i.e.,
low mobility in soil) such as TBBPA is not expected to be via
inhalation, but rather through ingestion because the TBBPA will
predominantly partition to soils and sediments if/when released to the
environment. The physical-chemical properties of TBBPA also indicate
that the fate of TBBPA into water would result in preferential
partitioning into sediments and biota (fish or other aquatic organism).
Available monitoring data support this conclusion, with higher
concentrations of TBBPA in soil and fish relative to concentrations in
air.
    Hence, additional toxicokinetic studies by the inhalation route is
not needed to conduct a reasoned determination or prediction of TBBPA
risk to birds.
    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. Diet and Drinking Water Exposures. a. Diet. 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 TBBPA via diet. Testing of food products for TBBPA
contamination, such as the plant uptake and translocation test (OCSPP
Test Guideline 850.4800) (Ref. 31) and modified methods for TBBPA using
the Food & Drug Administration's (FDA) Drug & Chemical Residues Methods
(Ref. 32), requested by the petitioners, is not necessary because
existing data are available to address this exposure pathway.
    While a plant uptake study combined with soil concentrations could
be used to estimate dietary exposures from plants, chemicals with low
water solubility and higher log KOW values similar to TBBPA
are less likely to bioaccumulate in plants compared to other foods,
such as meats, fish and dairy products (Ref. 33). Hence, other food
items, such as meats, fish and dairy products would be expected to be
primary contributors to dietary exposures. Available market basket
surveys for TBBPA support this, with most samples comprised of lipid-
rich food groups (Ref. 34). There were 465 food samples collected in
Europe between 2003 and 2010. Most of these were comprised of lipid-
rich food groups; however, some vegetable and grain based food groups
were sampled. All samples from this study were below the level of
quantification, which was approximately <1 ng/g wet weight, although
this varied by food group (Ref. 35). To address dietary exposure from
TBBPA, EPA could use a combination of approaches. First, there are
existing plant uptake studies available that could be used to estimate
TBBPA concentrations in plants from modeled or measured near-facility
soil concentrations (Refs. 36 and 37). These studies are not cited in
the petition. This approach is supported by a study, that EPA
identified since the Problem Formulation and Initial Assessment
document was published, that compared a wide variety of plant uptake
studies with available models that estimate soil to plant uptake (Ref.
38). Any modeled estimate can be compared to available measured data
and a range of values informed by both approaches could be derived. EPA
could model soil concentrations from TRI data; these concentrations
along with available physical-chemical properties can be used to
reasonably estimate plant concentrations and associated dietary
exposures. There is also an existing study that quantified soil and
plant TBBPA concentrations near a facility (Ref. 39). This data can be
used to supplement and/or evaluate the modeling approach. Because
existing approaches exist for estimating plant concentrations of TBBPA
(modeling and market basket data), the plant uptake and translocation
test (Ref. 31) is not necessary.
    EPA recognizes that dietary exposures come from a wide variety of
sources, not just plants. Market basket surveys provide food
concentrations, which can be used to estimate dietary exposure. There
are market basket surveys from other countries that measured TBBPA in
various food products (Refs. 40 to 42). Other studies are available
that provide data on TBBPA concentrations in breast milk or edible fish
(Refs. 43 to 48). Fish concentrations can also be estimated from
combining modeled or measured surface water concentrations with
bioaccumulation/bioconcentration factors (BAF/BCF). Ingestion from
other dietary sources, in addition to fish, shellfish, and breast milk
(dairy, meat, fruits and vegetables and grains), can be estimated
individually and in total using existing data. It is expected that
ingestion of foods with higher lipid content, such as fish and milk,
will contribute more to dietary exposure (Ref. 49) than other foods,
such as plants. Levels may vary based on proximity to point sources
when compared to levels detected in market basket surveys, and this can
be considered in developing exposure scenarios and/or background
estimates.

    b. Drinking 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 to TBBPA via
drinking water. Sampling of waters in the vicinity of representative
manufacturing and processing facilities known to discharge TBBPA,
requested by the petitioners, is not necessary because an existing
approach is available to address this exposure pathway.
    EPA can use release data collected under EPA's TRI program to
characterize TBBPA concentrations in surface water near TBBPA
manufacturing and processing facilities.
    In addition, while there are no data on TBBPA concentrations in
finished drinking water, EPA can use surface water monitoring data as a
surrogate for finished drinking water to assess potential risks posed
by drinking TBBPA-contaminated water. EPA's Office of Water routinely
derives Ambient Water Quality Criteria for the Protection of Human
Health (Ref. 50) using the assumption that people may ingest surface
water as a drinking water source over a lifetime. There are existing
data on TBBPA concentrations in surface water to conduct a drinking
water exposure assessment using surface water as a surrogate (Refs. 51
to 53).
    EPA believes these approaches are adequate, and likely
conservative, to assess potential exposures to drinking water. First,
the physical-chemical and fate properties of TBBPA, such as high
sorption, low water solubility, and high KOC indicate that
concentrations of TBBPA in drinking water would be expected to be low
prior to treatment. When sediment monitoring data is used with
assumptions about KOC, organic content, and density of water
and sediment, surface water concentrations can be estimated to be
generally low, below the highest levels reported in surface water
(Refs. 54 to 56). This is supported by existing surface water
monitoring data indicating the highest concentration of TBBPA in
surface water is 4.87 ug/L with most data below 1 ug/L (Refs. 57 and
58). These same chemical and fate properties would indicate that
drinking water treatment processes would further reduce TBBPA
concentrations in finished drinking water. Overall, the contribution to
exposure to TBBPA via drinking water is expected to be minimal.
    3. Exposure from Manufacturing and Processing. a. Communities. The
petition does not set forth facts demonstrating that there is
insufficient information available to EPA to reasonably determine or
predict exposure to TBBPA to communities near manufacturing and
processing facilities. 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. 60), sampling of soils, and
sampling of waters in the vicinity of representative manufacturing and
processing facilities known to discharge TBBPA, as requested by the
petitioners, is not necessary because EPA could use an alternative
approach to evaluate exposure to TBBPA to communities near
manufacturing and processing facilities. EPA could use release data
collected under EPA's TRI program and a Gaussian dispersion model, such
as AERMOD, to quantify air concentrations and air deposition to soil,
to water bodies and to sediments near manufacturing and processing
facilities. AERMOD is an EPA model that has been extensively reviewed
and validated based on comparisons with monitoring data (Ref. 60).
Variability and uncertainty associated with variable emission rates and
degradation over time can also be characterized using modeling
approaches whereas one-time or limited sampling cannot provide temporal
characterizations. In addition, EPA can use monitoring data from other
countries as surrogate ``near-facility'' monitoring data along with
modeled estimates. However, the petition does not address this
possibility, let alone explain why a testing order under section 4
would be necessary on this point. There are several references with
sampling locations near facilities that can be considered, many of
which were cited in the Problem Formulation and Initial Assessment
document (Ref. 2). EPA considers this approach to be reasonable to
determine exposure to communities near manufacturing or processing
facilities, but may decide to pursue targeted sampling in the future
near manufacturing and processing facilities to reduce uncertainty.
    b. Workers. The petition does not set forth facts demonstrating
that there is insufficient information available to EPA to reasonably
determine or predict exposure to TBBPA to workers in manufacturing and
processing facilities.
    Since publication of the Problem Formulation and Initial Assessment
document, EPA identified exposure monitoring data for Europe, China and
the United States for several industries (the manufacture of epoxy
resins and laminates; manufacture of printed circuit boards; and
compounding of acrylonitrile butadiene styrene (ABS) resin) (Refs. 61
to 66).
    As discussed previously, EPA is actively developing or evolving
approaches for implementing the new provisions in amended TSCA. One
such approach is to perform systematic literature reviews to identify
and/or develop additional available data and modeling approaches for
estimating worker inhalation exposure. EPA may also assess exposure
concentration in the case of conversion of compounded ABS resin to
finished products based on available monitoring data for other
industries, such as manufacture of epoxy resins and laminates and
manufacture of printed circuit boards. Furthermore, the National
Institute of Occupational Safety and Health (NIOSH) has initiated a
study titled: ``Assessment of Occupational Exposure to Flame
Retardants'' that aims to quantify, characterize occupational exposure
(inhalation, ingestion, or dermal) among workers, and to compare
workers' exposures to those of the general population (Ref. 67). Data
generated from the NIOSH study is expected to inform occupational
exposures and will be considered in an occupational assessment of
TBBPA. However, the petition fails to explain how it considered these
points or why a testing order under section 4 would be necessary for
additional information.
    EPA considers the approach considered in the previous paragraph to
be reasonable to determine exposure to workers in manufacturing and
processing facilities, but may decide to pursue targeted sampling in
the future near manufacturing and processing facilities to supplement
or refine these approaches.
    Dust. EPA believes the approaches described earlier in this unit
are sufficient to characterize exposures to workers at manufacturing or
processing facilities from external doses/concentrations. Sampling of
settled dust (surface wipe and bulk sampling) using the OSHA Technical
Manual (Ref. 68), as specifically requested by the petitioners, is not
needed. Presence of TBBPA 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. 69). EPA notes that in the NIOSH study that is in
progress surface wipe sampling is not included, which provides support
for

the conclusion that settled dust is not a customary measure for
occupational exposure. EPA would, however, 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. Therefore,
the biomonitoring data collected following the protocols of the current
NIOSH study, 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 any/all exposure routes.
    4. Exposure from recycling. The petition does not set forth facts
demonstrating that there is insufficient information available to EPA
to reasonably determine or predict communities specifically located at
or near and workers in facilities that recycle TBBPA-containing
products. In the Problem Formulation and Initial Assessment document
(Ref. 2), EPA identified three monitoring studies that describe
concentrations of TBBPA in soil, sediment, and sludge near
manufacturing and recycling facilities (Refs. 71, 72, 76). Since
publication of the Problem Formulation and Initial Assessment document
(Ref. 2), EPA has identified four monitoring studies that describe
concentrations of TBBPA in soil, sediment, indoor and outdoor dust from
sampling locations in and near e-waste recycling facilities in other
countries (Refs. 70, 73 to 75). These data may be useful for estimating
exposures at or near U.S. recycling facilities.
    However, EPA intends to further assess how comparable the nature
and magnitude of these types of facilities and handling of TBBPA-
containing products are to facilities within the U.S. EPA may collect
available information related to estimating potential extent and
magnitude of exposure. 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 be compared with the processes used in the studies
characterizing the foreign facilities. However, the petition does not
address this possibility, let alone explain why a testing order under
section 4 would be necessary on this point. If the processes are
similar, EPA could extrapolate from foreign facilities to U.S.
facilities. If EPA determines these previously indicated approaches are
not reasonable to determine exposures, then sampling of soils,
sediments and waters in the vicinity of facilities and air to which
workers may be exposed at facilities known to recycle TBBPA-containing
products, as requested by the petitioners, may become necessary. EPA
also notes that the NIOSH study, ``Assessment of Occupational Exposure
to Flame Retardants,'' (Ref. 67) may inform occupational exposures from
recycling facilities and will be considered in an occupational
assessment of TBBPA. 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.3.b., 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.
    5. Exposure from disposal. a. Landfills, wastewater treatment
plants, and sewage sludge. The petition does not set forth facts
demonstrating that there is insufficient information available to EPA
to reasonably determine or predict movement of TBBPA from landfills in
soil columns. Leaching studies (OCSPP Testing Guideline 835.1240) (Ref.
77), requested by the petitioners, are not necessary because an
existing approach is available to address this fate pathway. Studies
measuring the sorption of TBBPA to soil, sand columns, and sediment are
available as discussed in Appendix C of the Problem Formulation and
Initial Assessment document (Ref. 2). Larsen et al. (2001) reported
negligible leaching potential of TBBPA applied to soil and sand
columns. (Ref. 78). The adsorption of TBBPA to sediment has been
reported (Ref. 79) and suggest low mobility in soil and partitioning to
sediments. Data from these existing studies can also serve as input to
soil transport models to estimate mobility.
    The petition does not set forth facts demonstrating that there is
insufficient information available to EPA to reasonably determine or
predict transformation processes of TBBPA, which would be episodically
and/or continuously released to wastewater. The simulation tests to
assess the primary and ultimate biodegradability of chemicals
discharged to wastewater (OPPTS Test Guideline 835.3280) (Ref. 80),
requested by the petitioners, is not needed because primary degradation
and major transformation products can be determined from existing
studies on the ultimate biodegradability of TBBPA in aerobic and
anaerobic sludge. One of the studies (Ref. 81) was discussed in
Appendix C of EPA's Problem Formulation and Initial Assessment (Ref.
2). Two additional studies (Refs. 82 and 83) were identified after
publication of EPA's document (Ref. 2). Li, et al. (2015) (Ref. 82)
studied TBBPA transformation in nitrifying activated sludge (NAS).
TBBPA transformation was accompanied by mineralization. Twelve
metabolites, including those with single benzene ring, O-methyl TBBPA
ether, and nitro compounds, were identified during the study. Potvin et
al. (2012) (Ref. 83) measured the removal of TBBPA from influent to
conventional activated sludge, submerged membrane and membrane aerated
biofilm reactors. Removal of TBBPA from these wastewater treatment
systems was found to be due to a combination of adsorption and
biological degradation. Nyholm, et al. 2010 (Ref. 81) reported
transformation as biodegradation half-lives for TBPPA in aerobic
activated sludge, aerobic digested sludge, and anaerobic activated
sludge amended soils.
    The petition does not set forth facts demonstrating that there is
insufficient information available to EPA to reasonably determine or
predict effects from dietary exposure to crops where TBBPA contaminated
sewage sludge is applied. A plant uptake and translocation test (OCSPP
Test Guideline 850.4800) (Ref. 31), requested by the petitioners, is
not necessary because existing data are available to address this fate
pathway. As explained in the dietary exposure section, there are
existing plant uptake studies available (Refs. 36 and 37). These data
are also available to be used to estimate plant concentrations of
agricultural crops where TBBPA-containing sewage sludge is applied.
While a plant uptake study combined with sewage sludge concentrations
could be used to estimate dietary exposures from plants, chemicals with
low water solubility and higher log KOW values similar to
TBBPA, are less likely to bioaccumulate in plants compared to other
foods, such as meats, fish and dairy products (Ref. 33). Hence, other
food items, such as meats, fish and dairy products, would be expected
to be primary contributors to dietary exposures. Available market
basket surveys for TBBPA support this, with most samples comprised of
lipid-

rich food groups (Ref. 34). To address dietary exposure from TBBPA, EPA
could use a combination of approaches as described in the dietary
exposure section. EPA believes this approach can provide a reasonable
estimate of plant concentrations of agricultural crops grown where
TBBPA-containing sewage sludge was applied.
    b. Incineration. The petition does not set forth facts
demonstrating that there is insufficient information available to EPA
to reasonably determine or predict communities specifically located
near facilities that incinerate TBBPA or TBBPA-containing products.
    Electronic waste can be sent to waste-to-energy incinerators (Ref.
84). EPA's Problem Formulation and Initial Assessment for TBBPA (Ref.
2) included a study that measured TBBPA emissions (0.008 ng/L to air)
from a mixed household and commercial waste incinerator in Japan (Ref.
85). These data may be useful for estimating exposures at or near U.S.
facilities that incinerate TBBPA or TBBPA-containing products.
    EPA intends to further assess these facilities and could use an
approach that combines existing data to estimate the amount of
combustion products at incineration facilities that could have formed
from incinerating products that contain TBBPA. Such an approach could
combine information on:
    i. The types of by-products using data from EU (2006) (Ref. 62) and
U.S. EPA (Ref. 87);
    ii. information regarding types of consumer waste that contains
TBBPA and may be sent to incinerators;
    iii. information on the concentrations of TBBPA in various types of
consumer waste; some of these data are available (Refs. 86 to 91);
    iv. Toxics Release Inventory data on emissions of the dioxin, furan
and polycyclic aromatic hydrocarbons (PAH) by-products from
incinerators.
    The emissions of dioxins, furans and PAHs could then be modeled
using EPA's AERMOD air dispersion model (Ref. 60) and the amount of
these by-products that might be attributed to TBBPA could be
determined.
    Another approach that EPA could take is to estimate exposures near
facilities by grouping all near-facility data for a variety of
facilities (manufacturing, processing, e-waste, disposal) to estimate a
generic ``near-facility'' exposure. By estimating exposure in this
manner, EPA could take advantage of the larger number of monitoring
studies or modeled estimates.
    However, EPA intends to further assess how comparable locations
around incineration sites would be to those around manufacturing,
processing, e-waste, and other disposal facilities. There are factors
that may either increase and decrease emissions and potential
concentrations around these facilities. For example, elevated
temperatures are likely to eliminate some amount of possible TBBPA and
its combustion products which could reduce overall exposures. The waste
stream and content of TBBPA in materials as part of this waste stream
are likely to be highly variable and could result in emissions that are
higher or lower than those in manufacturing and processing facilities.
Comparison of facility specific information could inform which
categories of incineration may be sufficiently different from
manufacturing and processing facilities to potentially warrant
environmental sampling.
    Therefore, to complement the existing data, EPA could collect
available information related to estimating potential extent and
magnitude of exposure (for example, the number and location of
incineration facilities in the U.S. and the types and volumes of
products that are accepted by these sites). Waste disposal by
incineration as used in the United States could be then compared with
the processes used in the studies assessing the foreign facilities.
However, the petition does not address this possibility, let alone
explain why a testing order under section 4 would be necessary on this
point. If the processes are similar, EPA could extrapolate from foreign
facilities to U.S. facilities. If EPA determines these previously
indicated approaches are not reasonable to determine exposures, then
sampling of soils, sediments and waters in the vicinity of facilities
and air to which workers may be exposed at facilities known to
incinerate TBBPA or TBBPA-containing products, as requested by the
petitioners, may be necessary, but could be more strategic and better
targeted when based on deliberate evaluation of available existing data
and information.
    6. Exposure to degradation by-products. a. Degradation in water or
soil. The petition does not set forth facts demonstrating that there is
insufficient information available to EPA to reasonably determine or
predict degradation of TBBPA in water by direct photolysis. Studies
identifying photodegradation products of TBBPA formed by direct
photolysis in water under laboratory conditions (Ref. 92) were
identified after the Problem Formulation and Initial Assessment
document was published. Therefore, the photodegradation in water test
(OCSPP Test Guideline 835.2240) (Ref. 93), requested by the
petitioners, is not needed.
    The petition does not set forth facts demonstrating that there is
insufficient information available to EPA to reasonably determine or
predict reactions resulting from chemical or electronic excitation
transfer from light-absorbing humic species rather than from direct
sunlight for TBBPA. A study identifying indirect photodegradation
products of TBBPA formed by indirect photolysis in water under
laboratory conditions (Ref. 94) was identified after the Problem
Formulation and Initial Assessment document was published. Therefore,
the indirect photolysis in water test (OCSPP 835.5270) (Ref. 95),
requested by the petitioners, is not needed.
    The petition does not set forth facts demonstrating that there is
insufficient information available to EPA to reasonably determine or
predict degradation of TBBPA in soil by photolysis. Photolysis of TBBPA
deposited on soil or applied to soil with sludge is a possible fate
pathway, which could involve different pathways and mechanisms other
than photolysis in water. Existing aqueous photolysis studies and/or
predictive models can be used to reasonably predict the degradation
products of TBBPA. Environmental transport and exposure modeling could
be conducted using available measured or estimated physical-chemical
properties to estimate exposure of degradation products. This approach
has been used by others (Ref. 96) to estimate PBT properties for
degradation products. Therefore, the photodegradation in soil test
(OCSPP Test Guideline 835.2410) (Ref. 97), requested by the
petitioners, is not needed.
    b. Microbial degradation. The petition does not set forth facts
demonstrating that there is insufficient information available to EPA
to reasonably determine or predict microbial degradation of TBBPA in
soil in aerobic and anaerobic conditions. EPA has identified existing
studies/data describing aerobic and anaerobic biodegradation pathways
of TBBPA in both soil samples potentially pre-exposed and not pre-
exposed to TBBPA. Some studies are discussed in Appendix C of EPA's
Problem Formulation and Initial Assessment document (Refs. 81, 98 and
99). EPA identified two additional studies after publication of the
Problem Formulation and Initial Assessment document that also address
this endpoint (Refs. 82 and 100). These studies allow EPA to reasonably
determine transformation products and

predict relative rates from aerobic and anaerobic microbial degradation
in soil. Therefore, the aerobic and anaerobic transformation in soil
test (OECD Test Guideline 307) (Ref. 101) and terrestrial soil-core
microcosm test (OCSPP Test Guideline 850.4900) (Ref. 102), requested by
the petitioner, are not needed.
    The petition does not set forth facts demonstrating that there is
insufficient information available to EPA to reasonably determine or
predict aerobic aquatic biodegradation of TBBPA. Studies are available
(Refs. 103 and 104) to reasonably determine aerobic aquatic
biodegradation pathways and products as discussed in Appendix C of
EPA's Problem Formulation and Initial Assessment document (Ref. 2).
Therefore, the aerobic mineralization in surface water-simulation
biodegradation test (OCSPP Test Guideline 835.3190) (Ref. 105),
requested by the petitioner, is not needed.
    As noted in the exposure from disposal discussion, the petition
does not set forth facts demonstrating that there is insufficient
information available to EPA to reasonably determine or predict
degradation processes of TBBPA, which would be episodically and/or
continuously released to wastewater. The simulation tests to assess the
primary and ultimate biodegradability of chemicals discharged to
wastewater (OPPTS Test Guideline 835.3280) (Ref. 80), which the
petitioner cited in the discussion about exposure to degradation by-
products, is not needed.
    c. Combustion products. The petition does not set forth facts
demonstrating that there is insufficient information available to EPA
to reasonably determine or predict potential combustion products of
TBBPA. The reference to combustion testing cited by the petitioners and
others is available (Refs. 62 and 106). However, knowledge of the types
and volumes of TBBPA-containing products is needed to use this data to
estimate potential exposures to combustion products. As stated in the
Problem Formulation and Initial Assessment document (Ref. 2; page 91),
``. . . contribution of TBBPA to combustion byproducts is not possible
to determine.'' However, EPA could acquire this information from
recycling and incineration facilities using approaches described in
Units IV.C.4. and IV.C.5.b. The petition does not address this
possibility, let alone explain why a testing order under section 4
would be necessary on this point.
    d. Toxicity of degradation products. The petition does not set
forth facts demonstrating that there is insufficient information
available to EPA to reasonably determine or predict characterization of
TBBPA degradation products, and, as stated in Units IV.C.5.a, IV.C.6.a,
and IV.C.6.b., EPA has an understanding of the products potentially
formed from TBBPA degradation (e.g., tri-, di-, and monobromobisphenol
A, bisphenol A, TBBPA--bis(methyl ether), isopropyl dibromophenols).
EPA can use predictive models (e.g., EPA's EPISuite models (Ref. 107)
to estimate the key physical-chemical properties of these degradants.
EPISuite models have been validated and peer reviewed, and TBBPA
degradates are chemicals for which EPISuite models are suitable for
estimating (i.e., are within applicability domains of EPISuite models).
EPISuite has been used for estimating chemical properties in risk
assessments conducted by the USEPA, the EU, and Canada. Therefore, the
use of the EPA series 830 Group B testing guidelines (Ref. 108),
requested by the petitioners, is not needed.
    The petition does not set forth facts demonstrating that there is
insufficient information available to EPA to reasonably determine or
predict toxicity effects of TBBPA degradation products to mammals and
birds. The petition did not reflect a comprehensive search and review
for existing toxicity data on potential degradation products, and EPA's
Problem Formulation and Initial Assessment document (Ref. 2) did not
purport to represent such a comprehensive search for degradation
products. To address the need for mammal or avian toxicity under EPA's
current approach, EPA would conduct a comprehensive literature review
to identify existing data for these chemicals or for analogs. Following
identification and review of existing data, if EPA deemed specific
testing necessary to fill identified data gaps, EPA would consider
testing according to EPA series 850 Ecological Effects Test Guidelines
(Ref. 109), EPA series 870 Health Effects Test Guidelines (Ref. 110),
or appropriate OECD Guidelines.
    The petition does not set forth facts demonstrating that there is
insufficient information available to EPA to reasonably determine or
predict the toxicity effects of TBBPA degradation products to aquatic
organisms. The petition did not reflect a comprehensive search and
review for existing toxicity data on potential degradation products,
and EPA's Problem Formulation and Initial Assessment document (Ref. 2)
did not purport to represent such a comprehensive search. To address
the need for aquatic toxicity under EPA's current approach, EPA would
conduct a comprehensive literature review to identify existing data for
these chemicals or for analogs. EPA also believes there are alternative
approaches available to EPA regarding ecological effects of TBBPA
degradation products on aquatic organisms. EPA could use EPA's ECOSAR
(Ref. 111) to estimate the aquatic toxicity of these degradants. ECOSAR
is an expert system and collection of models (i.e., Quantitative
Structure Activity Relationships) that estimate toxicity from structure
and physical-chemical properties of a chemical. The models incorporated
into ECOSAR have been validated and peer reviewed. ECOSAR models are
suitable for estimating toxicity of potential TBBPA degradates (i.e.,
TBBPA degradation product chemicals are within the applicability
domains of ECOSAR models). Therefore, the use of the EPA series 850
testing guidelines (Ref. 109), requested by the petitioners, is not
needed for aquatic organisms.
    Furthermore, EPA's use of available existing toxicity information
and modeling approaches reduces the use of vertebrate animals in the
testing of chemical substances in a manner consistent with provisions
described in TSCA section 4(h).
    7. Hazard endpoints. a. Reproductive toxicity, developmental
toxicity and neurotoxicity. The petition does not set forth facts
demonstrating that there is insufficient information available to EPA
to reasonably determine or predict reproductive, developmental and
neurotoxicity of TBBPA. Therefore, the reproductive/developmental
toxicity screening test (OECD Test Guideline 421) (Ref. 112), NTP's
Modified One-Generation Reproduction Study (Ref. 113) and the
complementing Developmental Neurotoxicity Study (OECD Test Guideline
426) (Ref. 114), requested by the petitioners, are not necessary. EPA
has identified 15 reproductive/developmental toxicity tests conducted
by the oral route of which some include evaluation of neurotoxicity
endpoints. The available studies include: A one-generation reproduction
toxicity test (Refs. 115 and 9); two 2-generation reproduction tests
(Refs. 116 to 118); four prenatal developmental toxicity tests,
including a developmental neurotoxicity test (Refs. 119 to 122); and
six postnatal developmental toxicity tests, with some that also include
a prenatal component (Refs. 123 to 128). All of these studies, except
Hass et al. (2003) (Ref. 119) and Kim et al. (2015) (Ref. 126), were
described in Appendix G of the published Problem Formulation and
Initial Assessment document for TBBPA

(Ref. 2). These studies are either equivalent or superior to the
methods used in the reproductive/developmental toxicity screening test
(OECD Test Guideline 421) (Ref. 112) and the NTP Modified One-
Generation Reproduction Study (Ref. 113).
    For developmental neurotoxicity, a study for this endpoint by the
oral route is available (Ref. 119), and EPA would consider the results
of this study when evaluating risks from TBBPA. Although the study was
conducted when the Developmental Neurotoxicity Study OECD Test
Guideline 426 (Ref. 114) was a draft guideline, the study is adequate
for consideration as part of a weight-of-evidence analysis along with
the results of a 2-generation reproduction toxicity study that included
a neurotoxicity component (Ref. 121).
    Furthermore, EPA conducted an in-depth review of the existing
dataset of reproductive and developmental toxicity studies identified,
as well as additional animal and human data that evaluated
neurotoxicity endpoints (Refs. 131 and 116) following the publication
of the Problem Formulation and Initial Assessment document (Ref. 2) and
determined that the developmental, reproductive and neurotoxicity
endpoints are adequately addressed. Therefore, EPA could use this body
of existing data in selecting studies for use in risk evaluation.
    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. Amphibian endocrine system. The petition does not set forth
facts demonstrating that there is insufficient information available to
EPA to reasonably determine or predict adverse endocrine-related
effects from exposure to TBBPA. Therefore, the larval amphibian growth
and development assay (LAGDA) (OCSPP Test Guideline 890.2300) (Ref.
132) is not necessary. Data are available that address thyroid effects
of TBBPA for both bioactivity and dose response (Refs. 57 and 133 to
139). These data include mixed results in amphibians and more
consistent results in mammals indicating that changes in thyroid
hormones are associated with developmental effects (specifically
neurobehavioral effects). Given the weight-of-evidence, EPA does not
believe that the LAGDA would significantly change this conclusion.
Furthermore, EPA's use of this 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).
    8. EPA's conclusions. EPA denied the request to issue an order
under TSCA section 4 because the TSCA section 21 petition does not set
forth sufficient facts for EPA to find that the information currently
available to the Agency, including existing studies (identified prior
to or after publication of EPA's Problem Formulation and Initial
Assessment) on TBBPA and analogs, as well as alternate approaches for
risk evaluation, is insufficient to permit a reasoned determination or
prediction of the health or environmental effects of TBBPA 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 section 4(h) of TSCA, 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 Tetrabromobisphenol A (CAS No. 79-94-7) under
Section 4(a) of the Toxic Substances Control Act. December 13, 2016.
2. EPA. TSCA Work Plan Chemical Problem Formulation and Initial
Assessment Tetrabromobisphenol A and Related Chemicals Cluster Flame
Retardants. 2015.
3. World Health Organization International Agency for Research on
Cancer. IARC Monographs on the Evaluation of Carcinogenic Risks to
Humans. 2014. (retrieved on February 4, 2017) https://monographs.iarc.fr/ENG/Publications/internrep/14-002.pdf.
4. Hamers, T. et al. In Vitro Profiling of the Endocrine-Disrupting
Potency of Brominated Flame Retardants. Toxicological Sciences.
92:157. 2006.
5. Shi, H. et al. Teratogenic effects of tetrabromobisphenol A on
Xenopus tropicalis embryos. Comp. Biochemistry & Physiology Part C:
Toxicology & Pharmacology. 152:62[hyphen]68. 2010.
6. Zatecka, E. et al. Effect of tetrabrombisphenol A on induction of
apoptosis in the testes and changes in expression of selected
testicular genes in CD1 mice. Reproductive Toxicology. 35:32 2013.
7. Meerts, I. et al. In vitro estrogenicity of polybrominated
diphenyl ethers, hydroxylated PDBEs, and polybrominated bisphenol A
compounds. Environmental Health Perspective. 2001.
8. Pullen, S. et al. The flame retardants tetrabromobisphenol A and
tetrabromobisphenol A/bisallylether suppress the induction of
interleukin-2 receptor a chain (CD25) in murine splenocytes.
Toxicology. 2003.
9. Van der Ven, L. et al. Endocrine effects of tetrabromobisphenol-A
(TBBPA) in Wistar rats as tested in a one-generation reproduction
study and a subacute toxicity study. Toxicology. 2008.
10. EPA. Persistent Bioaccumulative Toxic (PBT) Chemicals; Lowering
of Reporting Thresholds for Certain PBT Chemicals; Addition of
Certain PBT Chemicals; Community Right-to-Know Toxic Chemical
Reporting; Final Rule. Federal Register. (Oct. 29, 1999, 64 FR
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11. EPA. Response to Petition to Order Testing of
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List of Subjects in 40 CFR Chapter I

    Environmental protection, Flame retardants, Hazardous substances,
tetrabromobisphenol A.

    Dated: March 10, 2017.
Wendy Cleland-Hamnett,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2017-05291 Filed 3-16-17; 8:45 am]
 BILLING CODE 6560-50-P