Summary of External Peer Review and Public Comments and Disposition for Cyclic Aliphatic Bromide Cluster (HBCD)
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Office of Chemical Safety and United States Pollution Prevention Environmental Protection Agency September 2020 Summary of External Peer Review and Public Comments and Disposition for Cyclic Aliphatic Bromide Cluster (HBCD) Response to Support Risk Evaluation of Cyclic Aliphatic Bromide Cluster (HBCD) September 2020 Table of Contents ABBREVIATIONS ....................................................................................................................... 4 Content and Organization ............................................................................................................... 8 Systematic Review – Public and Peer Review Comments ........................................................... 16 Environmental Fate and Transport................................................................................................ 30 Environmental Release ................................................................................................................. 46 Occupational Exposure ................................................................................................................. 55 Environmental, General Population, and Consumer Exposure .................................................... 75 Environmental Hazard .................................................................................................................. 96 Human Health Hazard................................................................................................................. 108 Environmental Risk Characterization ......................................................................................... 125 Human Health Risk Characterization ......................................................................................... 135 General Risk Characterization .................................................................................................... 146 EPA published the Draft Risk Evaluation for Cyclic Aliphatic Bromide Cluster (HBCD) in June 2019 and accepted public comments until August 28, 2019. Materials on the draft risk evaluation are available in docket EPA-HQ-OPPT-2019-0237. EPA held a peer review meeting of EPA’s Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation for this chemical’s condition of use on July 30-31, 2019. This document summarizes the public and external peer review comments that the EPA’s Office of Pollution Prevention and Toxics (OPPT) received for the risk evaluation of Cyclic Aliphatic Bromide Cluster (HBCD). It also provides EPA’s response to the comments received from the public and the peer review panel. EPA appreciates the valuable input provided by the public and peer review panel. The input resulted in numerous revisions to the risk evaluation document. Peer review charge questions1 are used to categorize the peer review and public comments into specific issues related to the five main themes. 1. Content, Organization and Clarity of the Document 2. Clarity in the Description of Literature Search, Literature Screening, and Data Evaluation 3. Environmental Exposure Assessment, Including Environmental Fate and Transport and Environmental Release Assessment 4. Hazard and Dose Response Assessment, Including Ecological, Occupational, General Population, and Consumer Receptors 5. Risk Characterization All peer review comments for the eight charge questions are presented first, organized by charge question. These are followed by the public comments. For each theme, general comments pertaining to all chemicals are presented first, and then additional comments pertaining to only one or several chemicals follow. 1 These are the questions that EPA submitted to the panel to guide the peer review process. Page 3 of 168 ABBREVIATIONS 7Q10 Lowest expected weekly flow over a ten-year period ADME Absorption, Distribution, Metabolism, and Excretion APF Assigned Protection Factors ATSDR Agency for Toxic Substances and Disease Registry BAF Bioaccumulation Factor BCF Bioconcentration Factor BMD Benchmark Dose Modeling BMDL Lower Confidence limit on the BMD BMR Benchmark Response CDR Chemical Data Reporting CHAD Consolidated Human Activity Database COC Concentration of Concern COU Condition of Use ECHA European Chemicals Agency ECOTOX ECOTOXicology knowledgebase E-FAST Exposure and Fate Assessment Screening Tool EPS Expanded Polystyrene ER Extra Risk ESD Emission Scenario Document EU European Union EURAR European Union Risk Assessment Report FR Federal Register GI tract Gastrointestinal tract g Gram HBCD/HBCDD Hexabromocyclododecane HERO Health and Environmental Research Online HIPS High Impact Polystyrene HPLC High Performance Liquid Chromatography HQ Headquarters hr Hour IECCU Indoor Environmental Concentrations in Buildings with Conditioned and Unconditioned Zones IIOAC Integrated Indoor-Outdoor Air Calculator KABAM KOW (based) Aquatic BioAccumulation Model kg Kilogram(s) Koa Octanol:Air Partition Coefficient L Liter(s) lb Pound LOAEL Lowest Observed Adverse Effect Level LOEC Lowest Observed Effect Concentration Log Koc Logarithmic Organic Carbon:Water Partition Coefficient Page 4 of 168 Log Kow Logarithmic Octanol:Water Partition Coefficient m3 Cubic Meter(s) MOA Mode of Action MOE Margin of Exposure MOEJ Ministry of Environment Government in Japan MSW Municipal Solid Waste MSWLF Municipal Solid Waste Landfills ND No Data NICNAS National Industrial Chemicals Notification and Assessment Scheme NIOSH National Institute for Occupational Safety and Health NOAEL No Observable Adverse Effect Level NOEC No Observed Effect Concentration OES Occupational Exposure Scenario ONU Occupational Non-User OPPT Office of Pollution Prevention and Toxics OSHA Occupational Safety and Health Administration PBDE Polybrominated Diphenyl Ether PBPK Physiologically Based Pharmacokinetic Model PDM Probabilistic Dilution Model PESS Potentially Exposed or Susceptible Subpopulations PNOR Particles Not Otherwise Regulated POD Point of Departure POPs Stockholm Convention on Persistent Organic Pollutants POTW Publicly Owned Treatment Works ppm Part(s) per Million RAR Risk Assessment Report RCRA Resource Conservation and Recovery Act REACH European Union’s Registration, Evaluation, Authorisation and Restriction of Chemicals SIPS Structural Insulated Panels SNUR Significant New Use Rule SOD Superoxide dismutase TGD Technical Guidance Document TRI Toxics Release Inventory TSCA Toxic Substances Control Act TSH Thyroid Stimulating Hormone TWA Time-Weighted Average UF Uncertainty Factor U.S. United States UNEP United Nations Environment Programme VVWM-PSC Variable Volume Water Model - Point Source Calculator WWT/WWTP Wastewater Treatment Plant XPS Extruded Polystyrene (i.e., Extruded Polystyrene foam) XPSA Extruded Polystyrene Association Page 5 of 168 List of Comments Comment # Docket File Submitter 24 EPA-HQ-OPPT-2019-0237-0024 Safer Chemicals Healthy Families 28 EPA-HQ-OPPT-2019-0237-0028 Environmental Protection Network 29 EPA-HQ-OPPT-2019-0237-0029 Earthjustice and Occupational Safety & Health Law Project LLC 30 EPA-HQ-OPPT-2019-0237-0030 Environmental Defense Fund 31 EPA-HQ-OPPT-2019-0237-0031 American Chemistry Council 33 EPA-HQ-OPPT-2019-0237-0033 Environmental Protection Network 41 EPA-HQ-OPPT-2019-0237-0041 State of Washington 43 EPA-HQ-OPPT-2019-0237-0043 MacRoy 44 EPA-HQ-OPPT-2019-0237-0044 Singla 45 EPA-HQ-OPPT-2019-0237-0045 Hartigan 47 EPA-HQ-OPPT-2019-0237-0047 Motor & Equipment Manufacturers Association 48 EPA-HQ-OPPT-2019-0237-0048 Environmental Protection Network 49 EPA-HQ-OPPT-2019-0237-0049 Alliance of Automobile Manufacturers 50 EPA-HQ-OPPT-2019-0237-0050 American Chemistry Council & NAFRA 51 EPA-HQ-OPPT-2019-0237-0051 American Chemistry Council 53 EPA-HQ-OPPT-2019-0237-0053 Alaska Community Action on Toxics 54 EPA-HQ-OPPT-2019-0237-0054 National Tribal Toxics Council 55 EPA-HQ-OPPT-2019-0237-0055 Occupational Safety & Health Law Project 56 EPA-HQ-OPPT-2019-0237-0056 Environmental Defense Fund 57 EPA-HQ-OPPT-2019-0237-0057 Safer Chemicals Healthy Families 58 EPA-HQ-OPPT-2019-0237-0058 Extruded Polystyrene Foam Association 59 EPA-HQ-OPPT-2019-0237-0059 UCSF 61 EPA-HQ-OPPT-2019-0237-0061 Environmental Risk Reduction and Project TENDR 62 EPA-HQ-OPPT-2019-0237-0062 Earthjustice 63 EPA-HQ-OPPT-2019-0237-0063 Toxics Use Reduction Institute Page 7 of 168 Content and Organization – Public and Peer Review Comments Charge Question 1.1: Please comment on the overall content, organization, and presentation of the draft risk evaluation for HBCD. Charge Question 1.2: Please provide suggestions for improving the clarity of the information presented in the documents. # Summary of Peer Review Comments for Specific Issues EPA/OPPT Response Related to Charge Question 1 Inconsistencies/errors SACC SACC COMMENTS: EPA stated in the draft risk evaluation that • A committee member expressed some concern that there are discrepancies “reuse, disposal, and recycling of HBCD- regarding exposure assessments of polystyrene (PS) insulation exposure, containing products from legacy uses are not particularly on page 39 where text indicates reuse and/or disposal will not be within the conditions of use of the draft risk evaluated. (p. 91) evaluation.” This statement applied to use and disposal of articles such as electronics devices for which HBCD manufacture, processing, and distribution for such use had ceased, but not to use and disposal of polystyrene insulation. EPA evaluated exposure from use of EPS and XPS containing HBCD; recycling of EPS and reuse of XPS; and disposal of EPS and XPS in