82 FR 14171 - Tetrabromobisphenol A (TBBPA); TSCA Section 21 Petition; Reasons for Agency Response
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 51 (March 17, 2017)
Federal Register Volume 82, Issue 51 (March 17, 2017)
| Page Range | 14171-14184 | |
| FR Document | 2017-05291 |
[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)] [Proposed Rules] [Pages 14171-14184] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05291] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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: (202) 564-4142; 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 (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 [[Page 14172]] 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 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 [[Page 14173]] 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 [[Page 14174]] 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 [[Page 14175]] 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 K OW = 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. [[Page 14176]] 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 [[Page 14177]] 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- [[Page 14178]] 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 [[Page 14179]] 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 [[Page 14180]] (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 58666) (FRL-6389-11). 11. EPA. Response to Petition to Order Testing of Tetrabromobisphenol A (CAS No. 79-94-7) Under Section 4(a) of the Toxic Substances Control Act. 2017. 12. EPA. Assessments for TSCA Work Plan Chemicals. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/assessments-tsca-work-plan-chemicals (retrieved on February 21, 2017). 13. EPA. Work Plan Chemical Problem Formulation and Initial Assessment and Data Needs Assessment Documents for Flame Retardant Clusters. 2015. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-problem-formulation-and-2. 14. 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. 15. 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. 16. EPA. Docket EPA-HQ-OPPT-2016-0654. 2016.https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0654-0001. 17. OECD. Test No 417: Toxicokinetics. Guideline for the testing of chemicals. [[Page 14181]] OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects. OECD Publishing, Paris. 2010. 18. OECD. Test No. 427: Skin Absorption: In Vivo Method. OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects. OECD Publishing, Paris. 2004. 19. Knudsen, G.A., J.M. Sanders, A.M. Sadik, and L.S. Birnbaum. Disposition and kinetics of tetrabromobisphenol A in female Wistar Han rats. Toxicology reports. 1, 214-223.2014. 20. Yu et al. Absorption and excretion of tetrabromobisphenol A in male Wistar rats following subchronic dermal exposure. Chemosphere. 146:189-194. 2016. 21. Klassen, C.D. Editor: Cassarett and Doull's Toxicology: The Basic Science of Poisons. Seventh Edition. McGraw-Hill Medical Publishing Division. New York. 2008. 22. Abdallah, M. A-E., Tilston, E., Harrad, S. and C. Collins. In vitro assessment of the bioaccessibility of brominated flame retardants in indoor dust using a colon extended model of the human gastrointestinal tract. Journal of Environmental Monitoring. 14:3276-3283. 2012. 23. IRDC (International Research and Development Corporation). 1975. Fourteen-Day Inhalation Toxicity Study in Rats (Unpublished). (as cited in EC, 2006). 24. EPA. Early Seedling Growth Toxicity. OCSPP Test Guideline 850.4230. 1998. 25. ACC-BFRIP (American Chemistry Council Brominated Flame Retardant Industry Panel). Tetrabromobisphenol A: A Toxicity Test to Determine the Effects of the Test Substance on Seedling Emergence of Six Species of Plants. Study conducted by Wildlife International Ltd., March 5. Project No 439-102. 2002. 26. EPA. Acute Inhalation Toxicity (OCSPP Test Guideline 870.1300). 1998. 27. Halldin, K., C. Berg, A. Bergman, I. Brandt, and B. Brunstrom. Distribution of Bisphenol a and Tetrabromobisphenol a in Quail Eggs, Embryos and Laying Birds and Studies on Reproduction Variables in Adults Following in Ovo Exposure. Archives of Toxicology. 75, 597- 603. 2001. 28. Berg, C., K. Halldin, and B. Brunstrom. Effects of Bisphenol a and Tetrabromobisphenol a on Sex Organ Development in Quail and Chicken Embryos. Environmental Toxicology and Chemistry. 20(12), 2836-2840. 2001. 29. Hudson, R.H., et al. Handbook of toxicity of pesticides to wildlife. Resource Publication. Washington, DC (1984). 30. Driver, C.J., Drown, D.B., Ligotke, M.W., Van Voris, P., McVeety, B.D. and Greenspan, B.J. Routes of uptake and their relative contribution to the toxicologic response of Northern bobwhite (Colinus virginianus) to an organophosphate pesticide. Environmental Toxicology and Chemistry. 10: 21-33. 1991. 31. EPA. Plant Uptake and Translocation (OCSPP Test Guideline 850.4800). 1998. 32. FDA. 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Kashiwagi, A., H. Hanada, M. Yabuki, T. Kanno, R. Ishisaka, J. Sasaki, M. Inoue, and K. Utsumi. Thyroxine Enhancement and the Role of Reactive Oxygen Species in Tadpole Tail Apoptosis. Free Radical Biology and Medicine. 26(7/8), 1001-1009. 1999. 139. Veldhoen, N., A. Boggs, K. Walzak, and C.C. Helbing. Exosure to Tetrabromobisphenol-a Alters Th-Associated Gene Expression and Tadpole Metamorphosis in the Pacific Tree Frog Pseudacris regilla. Aquatic Toxicology. 78, 292-302. 2006. 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
![Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Proposed Rules 14171
ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION: In the 21 petition was received from
AGENCY ‘‘Rules and Regulations’’ Section of Earthjustice, Natural Resources Defense
today’s Federal Register, we are Council, Toxic-Free Future, Safer
40 CFR Part 300 publishing a direct final Notice of Chemicals, Healthy Families, BlueGreen
Deletion of the Site without prior Notice Alliance, and Environmental Health
[EPA–HQ–SFUND–1983–0002; FRL–9959– of Intent to Delete because we view this Strategy Center on December 13, 2016.
04–Region 4] as a noncontroversial revision and The petitioners requested that EPA issue
anticipate no adverse comment. We an order under TSCA section 4,
National Oil and Hazardous have explained our reasons for this requiring that testing be conducted by
Substances Pollution Contingency deletion in the direct final Notice of manufacturers (which includes
Plan; National Priorities List: Deletion Deletion, and those reasons are importers) and processors on
of the Perdido Ground Water incorporated herein. If we receive no tetrabromobisphenol A (‘‘TBBPA’’)
Contamination Superfund Site adverse comment(s) on this deletion (CAS No. 79–94–7). After careful
action, we will not take further action consideration, EPA denied the TSCA
AGENCY: Environmental Protection on this Notice of Intent to Delete. If we section 21 petition for the reasons
Agency (EPA). receive adverse comment(s), we will discussed in this document.
ACTION: Proposed rule; notice of intent. withdraw the direct final Notice of DATES: EPA’s response to this TSCA
Deletion, and it will not take effect. We section 21 petition was signed March
SUMMARY: The Environmental Protection
will, as appropriate, address all public 10, 2017.
Agency Region 4 is issuing a Notice of
comments in a subsequent final Notice FOR FURTHER INFORMATION CONTACT:
Intent to Delete the Perdido Ground
of Deletion based on this Notice of For technical information contact:
Water Contamination Superfund Site
Intent to Delete. We will not institute a Virginia Lee, Chemical Control Division
(Site) located in Baldwin County,
second comment period on this Notice (7405M), Office of Pollution Prevention
Alabama, from the National Priorities
of Intent to Delete. Any parties and Toxics, Environmental Protection
List (NPL) and requests public
interested in commenting must do so at Agency, 1200 Pennsylvania Ave. NW.,
comments on this proposed action. The
this time. Washington, DC 20460–0001; telephone
NPL, promulgated pursuant to section For additional information, see the number: (202) 564–4142; email address:
105 of the Comprehensive direct final Notice of Deletion which is lee.virginia@epa.gov.
Environmental Response, located in the Rules section of this For general information contact: The
Compensation, and Liability Act Federal Register. TSCA-Hotline, ABVI-Goodwill, 422
(CERCLA) of 1980, as amended, is an South Clinton Ave., Rochester, NY
appendix of the National Oil and List of Subjects in 40 CFR Part 300
14620; telephone number: (202) 554–
Hazardous Substances Pollution Environmental protection, Air 1404; email address: TSCA-Hotline@
Contingency Plan (NCP). The EPA and pollution control, Chemicals, Hazardous epa.gov.
the State of Alabama, through the waste, Hazardous substances,
Alabama Department of Environmental SUPPLEMENTARY INFORMATION:
Intergovernmental relations, Penalties,
Management (ADEM), have determined Reporting and recordkeeping I. General Information
that all appropriate response actions requirements, Superfund, Water
under CERCLA have been completed. A. Does this action apply to me?
pollution control, Water supply.
However, this deletion does not This action is directed to the public
Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C.
preclude future actions under 9601–9657; E.O. 12777, 56 FR 54757, 3 CFR, in general. This action may, however, be
Superfund. 1991 Comp., p. 351; E.O. 12580, 52 FR 2923; of interest to those persons who are or
DATES: Comments must be received by 3 CFR, 1987 Comp., p. 193. may manufacture (which includes
April 17, 2017. Dated: September 6, 2016. import) or process the chemical
tetrabromobisphenol A (‘‘TBBPA’’)
ADDRESSES: Submit your comments, V. Anne Heard,
(CAS No. 79–94–7). Since other entities
identified by Docket ID no. EPA–HQ– Acting Regional Administrator, Region 4.
may also be interested, the Agency has
SFUND–1983–0002, by mail to Deborah [FR Doc. 2017–05289 Filed 3–16–17; 8:45 am]
not attempted to describe all the specific
P. Cox, PE, Remedial Project Manager, BILLING CODE 6560–50–P entities that may be affected by this
Superfund Restoration and action.
Sustainability Branch, Superfund
Division, U.S. Environmental Protection ENVIRONMENTAL PROTECTION B. How can I access information about
Agency, Region 4, 61 Forsyth Street AGENCY this petition?
SW., Atlanta, Georgia 30303–8960. The docket for this TSCA section 21
Comments may also be submitted 40 CFR Chapter I
petition, identified by docket
electronically or through hand delivery/ [EPA–HQ–OPPT–2016–0770; FRL–9960–09] identification (ID) number EPA–HQ–
courier by following the detailed OPPT–2016–0770, is available at http://
instructions in the ADDRESSES section of Tetrabromobisphenol A (TBBPA); www.regulations.gov or at the Office of
the direct final rule located in the rules TSCA Section 21 Petition; Reasons for Pollution Prevention and Toxics Docket
section of this Federal Register. Agency Response (OPPT Docket), Environmental
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
FOR FURTHER INFORMATION CONTACT: AGENCY: Environmental Protection Protection Agency Docket Center (EPA/
Deborah P. Cox, PE, Remedial Project Agency (EPA). DC), West William Jefferson Clinton
Manager, Superfund Restoration and ACTION: Petition; reasons for Agency
Bldg., Rm. 3334, 1301 Constitution Ave.
Sustainability Branch, Superfund response. NW., Washington, DC. The Public
Division, U.S. Environmental Protection Reading Room is open from 8:30 a.m. to
Agency, Region 4, 61 Forsyth Street SUMMARY: This document provides the 4:30 p.m., Monday through Friday,
SW., Atlanta, Georgia 30303–8960, reasons for EPA’s response to a petition excluding legal holidays. The telephone
phone 404–562–8317, email: it received under the Toxic Substances number for the Public Reading Room is
cox.deborah@epa.gov. Control Act (TSCA). The TSCA section (202) 566–1744, and the telephone
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![14172 Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Proposed Rules
number for the OPPT Docket is (202) section 4(a)(1)(A)(i). Id. If EPA denies a • Multiple in vitro and animal tests,
566–0280. Please review the visitor petition for a TSCA section 4 rule or where TBBPA has been detected to
instructions and additional information order and the petitioners challenge that cause endocrine effects, reproductive
about the docket available at http:// decision, TSCA section 21 allows a effects, neurological effects, and
www.epa.gov/dockets. court to order EPA to initiate the action immunological effects (Refs. 4–9).
requested by the petitioner if the The petitioners also note that EPA,
II. TSCA Section 21 petitioner demonstrates to the upon adding TBBPA in 1999 to the
A. What is a TSCA section 21 petition? satisfaction of the court by a Toxics Release Inventory (TRI)
preponderance of the evidence in a de established under the Emergency
Under TSCA section 21 (15 U.S.C.
novo proceeding that findings very Planning and Community Right to
2620), any person can petition EPA to
similar to those described in this unit Know Act, concluded that ‘‘TBBPA is
initiate a rulemaking proceeding for the
with respect to a chemical substance toxic’’ because ‘‘[i]t has the potential to
issuance, amendment, or repeal of a rule
have been met. kill fish, daphnid, and mysid shrimp,
under TSCA section 4, 6, or 8 or an
among other adverse effects, based on
order under TSCA section 4 or 5(e) or III. Summary of the TSCA Section 21
chemical and/or biological
(f). A TSCA section 21 petition must set Petition
interactions.’’ 64 FR 58666, 58708. The
forth the facts that are claimed to
A. What action was requested? petitioners assert there is TBBPA
establish the necessity for the action
On December 13, 2016, Earthjustice, exposure to humans and the
requested. EPA is required to grant or
Natural Resources Defense Council, environment based on the following
deny the petition within 90 days of its
Toxic-Free Future, Safer Chemicals, conclusions.
filing. If EPA grants the petition, the • TBBPA has the highest production
Agency must promptly commence an Healthy Families, BlueGreen Alliance,
and Environmental Health Strategy volume of any brominated flame
appropriate proceeding. If EPA denies retardant and is extensively used in
the petition, the Agency must publish Center petitioned EPA to issue an order
under TSCA section 4(a)(1), 90 days consumer products, including
its reasons for the denial in the Federal children’s products (Ref. 2). The
Register. A petitioner may commence a after the petition was filed, requiring
that testing be conducted by potential for widespread exposure is
civil action in a U.S. district court to extremely high.
compel initiation of the requested manufacturers (which includes
importers) and processors on • In 2012, TRI indicated that 127,845
rulemaking proceeding within 60 days pounds of TBBPA were released into the
of either a denial or the expiration of the tetrabromobisphenol A (‘‘TBBPA’’)
(CAS No. 79–94–7) (Ref. 1). environment (Ref. 2). Such releases
90-day period. indicate the potential for widespread
B. What criteria apply to a decision on B. What support do the petitioners offer? exposure in the population.
a TSCA section 21 petition? The petitioners state section 4(a)(1) of • The presence of TBBPA in people
TSCA requires EPA to direct testing on and the environment (biota and
1. Legal standard regarding TSCA environmental media) is established and
section 21 petitions. Section 21(b)(1) of a chemical substance or mixture if it
finds the following criteria are met: affirmed in EPA’s TBBPA Problem
TSCA requires that the petition ‘‘set Formulation and Initial Assessment
1. The manufacture, distribution in
forth the facts which it is claimed (Ref. 2).
commerce, processing, use, or disposal
establish that it is necessary’’ to issue With the evidence of toxicity and
of a chemical substance or mixture, or
the rule or order requested. 15 U.S.C. exposure and EPA’s addition of TBBPA
that any combination of such activities,
2620(b)(1). Thus, TSCA section 21 may present an unreasonable risk of to TRI (Ref. 10), the petitioners argue
implicitly incorporates the statutory injury to health or the environment. that TBBPA clearly meets the TSCA
standards that apply to the requested 2. There is insufficient information section 4 criteria for ‘‘may present an
actions. Accordingly, EPA has relied on and experience upon which the effects unreasonable risk of injury to health or
the standards in TSCA section 21 and in of such manufacture, distribution in the environment.’’
the provisions under which actions commerce, processing, use, or disposal The petitioners also assert there is
have been requested to evaluate this of such substance or mixture, or of any ‘‘insufficient information’’ on TBBPA
TSCA section 21 petition. In addition, combination of such activities on health based on EPA’s TBBPA Problem
TSCA section 21 establishes standards a or the environment can reasonably be Formulation (Ref. 2), which petitioners
court must use to decide whether to determined or predicted. say cited lack of data for:
order EPA to initiate rulemaking in the 3. Testing is necessary to develop • Dermal and inhalation exposures,
event of a lawsuit filed by the petitioner such information. diet and drinking water exposures,
after denial of a TSCA section 21 The petitioners assert that TBBPA exposures to communities near facilities
petition. 15 U.S.C. 2620(b)(4)(B). ‘‘may present an unreasonable risk of that manufacture and process TBBPA,
2. Legal standard regarding TSCA injury to health or the environment’’ exposures to communities near facilities
section 4 rules. EPA must make several because there is substantial evidence where ‘‘e-waste’’ is disposed of and
findings in order to issue a rule or order that TBBPA may be toxic, including recycled, exposures to the workers in
to require testing under TSCA section conclusions from: manufacturing, processing, disposal and
4(a)(1)(A)(i). In all cases, EPA must find • EPA’s TSCA Work Plan Chemical recycling facilities, and exposures to
that information and experience are Problem Formulation and Initial degradation and combustion products.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
insufficient to reasonably determine or Assessment (Ref. 2), which states • developmental, reproductive and
predict the effects of a chemical TBBPA ‘‘can be considered hazardous to neurological toxicity, endocrine
substance on health or the environment the environment’’ and that ‘‘there is disruption, and genotoxic effects.
and that testing of the chemical some concern’’ for certain cancers and The petitioners argue that the testing
substance is necessary to develop the developmental effects. recommended in the petition is critical
missing information. 15 U.S.C. • The International Agency for to address this allegedly insufficient
2603(a)(1). In addition, EPA must find Research on Cancer (IARC) has information and for performing any
that the chemical substance may present identified TBBPA as probably TSCA section 6 risk evaluation of
an unreasonable risk of injury under carcinogenic to humans (Ref. 3). TBBPA, and they request EPA to not
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![14174 Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Proposed Rules
or the environment under TSCA section Assessment document (Ref. 2) and the use of vertebrate animals in the testing
4(a)(1)(A). EPA also agrees that the dermal toxicokinetics study identified of chemical substances in a manner
Problem Formulation and Initial by the petitioners (Ref. 19). These consistent with provisions described in
Assessment was not comprehensive in available studies are sufficient to TSCA section 4(h).
scope with regard to the conditions of reasonably determine the internal doses The petition does not set forth facts
use of TBBPA, exposure pathways/ of TBBPA for purposes of route-to-route demonstrating that there is insufficient
routes, or potentially exposed (oral to dermal) extrapolation. The 2016 information available to EPA to
populations. However, the Problem Yu et al. study, cited in the petition (Ref. reasonably determine or predict effects
Formulation and Initial Assessment was 1), characterizes absorption and to the environment, specifically, toxicity
not designed to be comprehensive. elimination, while distribution and to plants exposed to TBBPA via the air.
Rather, the Problem Formulation and metabolism characterization is available Therefore, the early seedling growth
Initial Assessment was developed under from studies using intravenous dosing toxicity test (OCSPP Test Guideline
EPA’s then-existing process, as (Ref. 20). Furthermore, the available 850.4230) (Ref. 24), requested by the
explained previously. It was a fit-for- studies do not indicate differential petitioners, is not needed. As previously
purpose document to meet a TSCA distribution, metabolism, and mentioned, because TBBPA is a solid, it
Work Plan (i.e., pre-Lautenberg Act) elimination specific to skin. Therefore, may be reasonably predicted that
need. Going forward under TSCA, as the dermal toxicokinetics study particulates in the air are the primary
amended, EPA will conform its analyses requested by the petitioners is not form of TBBPA that would exist in air.
to TSCA, as amended. EPA has needed to inform or refine evaluation of Furthermore, as stated on page 88 of
explained elsewhere how the Agency dermal exposures. EPA’s Problem Formulation and Initial
proposes to conduct prioritization and b. Inhalation toxicity. The petition
Assessment document (Ref. 2),
risk evaluation going forward (Refs. 15 does not set forth facts demonstrating
‘‘[u]ltimately air releases of TBBPA
and 16). However, EPA does not find that there is insufficient information
would be expected to undergo
that the petitioners have demonstrated, available to EPA to reasonably
deposition to terrestrial and aquatic
for each exposure pathway and hazard determine or predict effects to health
environments . . .’’ and ‘‘TBBPA tends
endpoint presented in the petition, that from inhalation exposure to TBBPA.
to partition to soil and sediment . . .’’.
the existing information and experience Therefore, the toxicokinetics test (OECD
These fate pathways for TBBPA are also
available to EPA are insufficient to Test Guideline 417) (Ref. 17) via the
shown in Figure 2–1 of EPA’s Problem
reasonably determine or predict the inhalation route, requested by the
petitioners, is not needed. As described Formulation and Initial Assessment
effects on health or the environment
in EPA’s Problem Formulation and document (Ref. 2). Hence, exposure of
from ‘‘manufacture, distribution in
Initial Assessment (Ref. 2), EPA will use plants to TBBPA is expected to occur
commerce, processing, use, or disposal’’
an alternative approach to evaluate risks primarily via soil and sediments after
of TBBPA (or any combination of such
from inhalation exposure to TBBPA. deposition from air, which is why EPA
activities) nor that the specific testing
Because TBBPA is a solid, it may be excluded this pathway from further
they have identified is necessary to
reasonably predicted that particulates in assessment (Ref. 2, page 42), although
develop such information.
The discussion that follows provides the air are the primary form of TBBPA EPA in the Problem Formulation and
the reasons for EPA’s decision to deny that would be inhaled. TBBPA particles Initial Assessment document mistakenly
the petition based on the finding for in air that are inhaled are subsequently mentioned plants in another sentence
each requested test that the information swallowed via the mucociliary escalator addressing ‘‘[e]xposure via directly
on the individual exposure pathways (Ref. 21). Once the particles are in the inhaling [emphasis added] TBBPA,’’
and hazard endpoints identified by the gastrointestinal tract, absorption can even though direct inhalation is not
petitioners does not demonstrate that reasonably be assumed to be the same applicable to plants and thereby may
there is insufficient information upon as in the oral toxicity studies and hence, have caused potential confusion to
which the effects of TBBPA can oral toxicity studies can be used for risk readers. If toxicity of TBBPA to plants
reasonably be determined or predicted assessment. Information is also available were to be included in an assessment,
or that the requested testing is necessary to estimate bioaccessibility of TBBPA toxicity data following exposure via soil
to develop additional information. The from dust using an extraction test with and/or sediment exposures, not air,
sequence of EPA’s responses follows the an in vitro colon (Ref. 22). This would be the scientifically relevant data
sequence in which requested testing additional information could also be needed. To this end, as described in
was presented in the petition (Ref. 1). considered when evaluating risks from EPA’s Problem Formulation and Initial
1. Dermal and Inhalation Exposure TBBPA via the oral route. This approach Assessment (Ref. 2), existing data and
Toxicity. a. Dermal toxicity. The would not require conducting the information on phytotoxicity of TBBPA
petition does not set forth facts requested toxicokinetics test (Ref. 17). to six plant species is available (Ref. 25).
demonstrating that there is insufficient Although a small percent of TBBPA EPA’s Problem Formulation and Initial
information available to EPA to particles may be in the respirable range Assessment document (Ref. 2) included
reasonably determine or predict effects and may be absorbed directly through references for and a brief description of
to health from dermal exposure to the lungs, existing tests show that no the existing plant toxicity data (page
TBBPA. Therefore, the toxicokinetics systemic effects were observed in a 14- 105). While assessment of soil-dwelling
test (Organisation for Economic Co- day inhalation toxicity study (Ref. 23). organisms is included in EPA’s Problem
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
operation (OECD) Test Guideline 417) Therefore, EPA considers that assuming Formulation and Initial Assessment
(Ref. 17) via the dermal route and the all inhaled particles are eventually document (Ref. 2), as depicted in Figure
skin absorption: In vivo test (OECD Test swallowed and using existing oral 2–1 and described on page 40, EPA
Guideline 427) (Ref. 18), requested by toxicity data should not underestimate indicated that the environmental risk
the petitioners, are not needed. The effects from inhaling TBBPA particles assessment for the soil exposure
information already available includes and therefore would reasonably predict pathway would be based on
oral toxicity studies and oral such effects. concentrations of concern derived from
toxicokinetic studies identified in EPA’s Furthermore, EPA’s use of available data for soil invertebrates (Ref. 2; Figure
Problem Formulation and Initial existing toxicity information reduces the 2–1; Table 2–6; Page 40). Support for
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![14182 Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Proposed Rules
Hexabromocyclododecane, decabromodiphenyl ether in workers 75. Wu, Y, et al. Tetrabromobisphenol A and
Tetrabromobisphenol a, and Related manufacturing or handling flame- heavy metal exposure via dust ingestion
Compounds in Sewage Sludge and retarded rubber. Environmental Science in an e-waste recycling region in
Sediment Samples from Ebro River Basin and Technology. 39:1980–1986. 2005. southeast China. Science of the Total
(Spain). Analytical and Bioanalytical 66. Zhou, X., J. Guo, W. Zhang, P. Zhou, J. Environment. 541: 356–364. 2016.
Chemistry, 397, 2817–2824. Deng, and K. Lin. 2014. 76. Xu, T., J. Wang, S.-z. Liu, C. Lu, W.L.
56. Zhang, X.L., X.J. Luo, S.J. Chen, J.P. Wu, Tetrabromobisphenol A Contamination Shelver, Q. X. Li, and J. Li. A highly
and B.X. Mai. 2009. Spatial Distribution and Emission in Printed Circuit Board sensitive and selective immunoassay for
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and Decabromodiphenylethane in River 35. Acta. 751, 119–127. 2012.
Sediment from an Industrialized Region 67. NIOSH. Assessment of Occupational 77. EPA. Leaching studies (OCSPP Test
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57. Yang, S., Z. Yan, F. Xu, S. Wang, and F. bsc/2014/dec/nioshupdate_508.pdf. Hakk. Mobility, Sorption and Fate of
Wu. Development of freshwater aquatic 68. OSHA. OSHA Technical Manual (OTM), Tetrabromobisphenol a (TBBPA) in
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58. Harrad, S., M.A. Abdallah, N.L. Rose, S.D. 69. Gorman Ng, M., Semple, S., Cherrie, J.W., Analysis and Fate, Products, Standards
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ambient/airtox/to-9arr.pdf. Flame retardant emission from e-waste to Chironomus tentans under Flow-
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Atmospheric Modeling, Meteorological organophosphorus esters used as Study conducted by Breteler, R.J., J.R.
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End-User Survey—Phase 1. Study Identification of tetrabromobisphenol A 80. EPA. Simulation tests to assess the
conducted by Breysse, P., and J. allyl ether and tetrabromobisphenol A primary and ultimate biodegradability of
Kacergis, Johns Hopkins School of 2,3-dibromopropyl ether in the ambient chemicals discharged to wastewater
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63. Mäkinen, M.S.E., Mäkinen, M.R.A., Distribution of metals and brominated 83. Potvin, C.M., Z. Long, and H. Zhou.
Koistinen, J.T.B., Pasanen, A., Pertti, flame retardants (BFRs) in sediments, Removal of tetrabromobisphenol a by
O.P., Kalliokoski, P.J., and Korpi, A.M. soils and plants from an informal e-waste conventional activated sludge,
Respiratory and Dermal Exposure to dismantling site, South China. submerged membrane and membrane
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947. 2009. Johnson-Restrepo, T. A. Kumosani, G. 530–R–11–002. Office of Resource
64. Rosenberg, C., M. Hameila, J. Tornaeus, Malarvannan, T.B. Minh, H.-B. Moon, H. Conservation and Recovery, Washington,
K. Sakkinen, K. Puttonen, A. Korpi, M. Nakata, R.K. Sinha, and K. Kannan. A DC. 2011. http://www.epa.gov/osw/
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2011. Exposure to Flame Retardants in exposure to tetrabromobisphenol A and fullbaselinereport2011.pdf.
Electronics Recycling Sites. Ann Occup eight bisphenols including bisphenol A 85. Borgnes, D., and B. Rikheim.
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![14184 Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Proposed Rules
Tetrabromobisphenol A with Cover revised test plan. Robust summaries & DEPARTMENT OF COMMERCE
Letter Dated 04/17/78. 0200479. 1978. test plans: Phenol, 4,4′-
123. Eriksson, P., E. Jakobsson, and A. isopropylidenbis[2,6-dibromo-. 2006. National Oceanic and Atmospheric
Fredriksson. Developmental (retrieved in 2013) http://www.epa.gov/ Administration
Neurotoxicity of Brominated Flame chemrtk/pubs/summaries/phenolis/
Retardants, Polybrominated Diphenyl
c13460rt3.pdf. 50 CFR Part 217
Ethers, and Tetrabromobisphenol A.
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377. 1998. A. Bergman. Frog Embryo Teratogenic
124. Eriksson, P., E. Jakobsson, and A. Assay: Xenopus (FETAX) Analysis of the RIN 0648–BG50
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Retardants: A Novel Class of Tetrabromobisphenol a (TBBPA). Poster Taking and Importing Marine
Developmental Neurotoxicants in Our presentation at Second International Mammals; Taking Marine Mammals
Environment? Environmental Health Workshop on Brominated Flame Incidental to Commercial Fireworks
Perspectives. 109, 903–908. 2001. Retardants, May 14–16, Stockholm Displays at Monterey Bay National
125. Fukuda, N., Y. Ito, M. Yamaguchi, K. University, Sweden. 2001. Marine Sanctuary
Mitumori, M. Koizumi, R. Hasegawa, E.
135. Balch, G.C., and C.D. Metcalfe. In Vivo
Kamata, and M. Ema. Unexpected AGENCY: National Marine Fisheries
Nephrotoxicity Induced by Toxicity Testing of PBDEs Using Early
Life Stages of the Japanese Medaka and
Service (NMFS), National Oceanic and
Tetrabromobisphenol a in Newborn Rats. Atmospheric Administration (NOAA),
Toxicology Letters. 150, 145–155. 2004. the Xenopus Tail Resorption Model. 3rd
Annual Workshop on Brominated Flame Commerce.
126. Kim, B., E. Colon, S. Chawla, L.N.
Vandenberg, and A. Suvorov. Endocrine Retardants in the Environment. Canada ACTION: Proposed rule; request for
disruptors alter social behaviors and Centre for Inland Waters, August 23–24, comments.
indirectly influence social hierarchies pp. 59–60. 2001. (as cited in EC, 2006
via changes in body weight. and ACC, 2006).
SUMMARY: NMFS has received a request
Environmental health: A global access 136. Brown, D.D., Z. Wang, J.D. Furlow, A.
from the Monterey Bay National Marine
science source. 14, 64. 2015.
Kanamori, R.A. Schawartzman, B.F.
Sanctuary (MBNMS or Sanctuary) for
127. Saegusa, Y., H. Fujimoto, G.H. Woo, K. authorization to take marine mammals
FRemo, and A. Pinder. The thyroid
Inoue, M. Takahashi, K. Mitsumori, A. incidental to commercial fireworks
Nishikawa, and M. Shibatani. hormone-induced tail resorption
program during Xenopus laevis displays permitted by the Sanctuary in
Developmental Toxicity of Brominated California, over the course of five years
Flame Retardants, Tetrabromobisphenol metamorphosis. Developmental Biology.
a and 1,2,5,6,9,10- 93:1924–1929. 1996. (2017–2022). As required by the Marine
Hexabromocyclododecane, in Rat 137. Hanada, H., K. Katsu, T. Kanno, E.F. Mammal Protection Act (MMPA), NMFS
Offspring after Maternal Exposure from Sato, A. Kashiwagi, J. Sasaki, M. Inoue, is proposing regulations to govern that
Mid-Gestation through Lactation. and K. Utsumi. Cyclosporin a Inhibits take, and requests comments on the
Reproductive Toxicology. 28, 456–467. Thyroid Hormone-Induced Shortening of proposed regulations.
2009. the Tadpole Tail through Membrane DATES: Comments and information must
128. Saegusa, Y., H. Fujimoto, G.H. Woo, T. Permeability Transition. Comparative be received no later than April 17, 2017.
Ohishi, L. Wang, K. Mitsumori, A.
Biochemistry and Physiology. Part B, ADDRESSES: You may submit comments
Nishikawa, and M. Shibutani. Transient
Aberration of Neuronal Development in 135, 473–483. 2003. on this document, identified by NOAA–
the Hippocampal Dentate Gyrus after 138. Kashiwagi, A., H. Hanada, M. Yabuki, T. NMFS–2017–0017, by any of the
Developmental Exposure to Brominated Kanno, R. Ishisaka, J. Sasaki, M. Inoue, following methods:
Flame Retardants in Rats. Archives of and K. Utsumi. Thyroxine Enhancement • Electronic submission: Submit all
Toxicology. 86(9), 1431–1442. 2012. and the Role of Reactive Oxygen Species electronic public comments via the
129. Tada, Y., T. Fujitani, N. Yano, H. in Tadpole Tail Apoptosis. Free Radical federal e-Rulemaking Portal. Go to
Takahashi, K. Yuzawa, H. Ando, Y. Biology and Medicine. 26(7/8), 1001– www.regulations.gov/
Kubo, A. Nagasawa, A. Ogata, and H. 1009. 1999.
Kamimura. Effects of
#!docketDetail;D=NOAA-NMFS-2017-
139. Veldhoen, N., A. Boggs, K. Walzak, and 0017, click the ‘‘Comment Now!’’ icon,
Tetrabromobisphenol a, a Brominated C.C. Helbing. Exosure to
Flame Retardant, in ICR Mice after complete the required fields, and enter
Tetrabromobisphenol-a Alters Th- or attach your comments.
Prenatal and Postnatal Exposure. Food
and Chemical Toxicology. 44(8), 1408– Associated Gene Expression and Tadpole • Mail: Submit written comments to
1413. 2006. Metamorphosis in the Pacific Tree Frog Jolie Harrison, Chief, Permits and
130. Viberg, H., and P. Eriksson. Differences Pseudacris regilla. Aquatic Toxicology. Conservation Division, Office of
in Neonatal Neurotoxicity of Brominated 78, 292–302. 2006. Protected Resources, National Marine
Flame Retardants, PBDE 99 and TBBPA, Fisheries Service, 1315 East West
in Mice. Toxicology. 289(1), 59–65. 2011. List of Subjects in 40 CFR Chapter I
Highway, Silver Spring, MD 20910.
131. Kicinski, M., M.K. Viaene, E.D. Hond, G.
Schoeters, A. Covaci, A.C. Dirtu, V.
Environmental protection, Flame Instructions: Comments sent by any
Nelen, L. Bruckers, K. Croes, I. Sioen, W. retardants, Hazardous substances, other method, to any other address or
Baeyens, N. Van Larebeke, and T.S. tetrabromobisphenol A. individual, or received after the end of
Nawrot. 2012. Neurobehavioral Function Dated: March 10, 2017.
the comment period, may not be
and Low-Level Exposure to Brominated considered by NMFS. All comments
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Flame Retardants in Adolescents: A Wendy Cleland-Hamnett, received are a part of the public record
Cross-Sectional Study. Environmental Acting Assistant Administrator, Office of and will generally be posted for public
Health, 11, 1–12. Chemical Safety and Pollution Prevention. viewing on www.regulations.gov
132. EPA. Larval amphibian growth and [FR Doc. 2017–05291 Filed 3–16–17; 8:45 am] without change. All personal identifying
development assay (LAGDA) (OCSPP
Test Guideline 890.2300). 2002. BILLING CODE 6560–50–P information (e.g., name, address),
133. ACC. HPV Data Summary and Test Plan confidential business information, or
for Phenol, 4,4′-Isopropylidenbis[2,6- otherwise sensitive information
Dibromo- (Tetrabromobisphenol a, submitted voluntarily by the sender will
TBBPA). Test plan revision/updates, be publicly accessible. NMFS will
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| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Petition; reasons for Agency response. | |
| Dates | EPA's response to this TSCA section 21 petition was signed March 10, 2017. | |
| 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: (202) 564-4142; email | |
| FR Citation | 82 FR 14171 |
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