Staff Briefing Package Project Plan: Organohalogen Flame Retardant Chemicals Assessment July 1, 2020 CPSC Consumer Hotline and General Information: 1-800-638-CPSC (2772) CPSC's Web Site: http://www.cpsc.gov THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION UNDER CPSA 6(b)(1) Acknowledgments The preparation, writing, and review of this report was supported by a team of staff. We acknowledge and thank team members for their significant contributions. Michael Babich, Ph.D., Directorate for Health Sciences Charles Bevington, M.P.H., Directorate for Health Sciences Xinrong Chen, Ph.D., D.A.B.T., Directorate for Health Sciences Eric Hooker, M.S., D.A.B.T., Directorate for Health Sciences Cynthia Gillham, M.S., Directorate for Economic Analysis John Gordon, Ph.D., Directorate for Health Sciences Kristina Hatlelid, Ph.D., M.P.H., Directorate for Health Sciences Barbara Little, Attorney, Office of the General Counsel Joanna Matheson, Ph.D., Directorate for Health Sciences ii THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION UNDER CPSA 6(b)(1) Table of Contents Briefing Memo ............................................................................................................................... iv 1. Executive summary .............................................................................................................. 5 2. Introduction .......................................................................................................................... 7 3. Background .......................................................................................................................... 7 4. CPSC Staff’s Plan for Class-Based Risk Assessment of OFRs ......................................... 17 5. Staff Recommendations ..................................................................................................... 24 6. Specific Recommended Activities for Fiscal Year 2021 ................................................... 26 7. Staff Conclusions ............................................................................................................... 33 TAB A: Technical Approach to Hazard Assessment Using Class-Based Approach ................... 34 TAB B: Technical Approach to Assess Exposures Using a Class-Based Approach .................... 45 TAB C: Technical Support Activities for Class-Based Risk Assessment .................................... 52 TAB D: Preliminary Profile of the OFR Chemical Market .......................................................... 69 TAB E: Glossary ........................................................................................................................... 89 iii THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION UNDER CPSA 6(b)(1) Briefing Memo iv THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION UNDER CPSA 6(b)(1) UNITED STATES CONSUMER PRODUCT SAFETY COMMISSION 4330 EAST WEST HIGHWAY BETHESDA, MARYLAND 20814 Memorandum Date: July 1, 2020 TO: The Commission Alberta E. Mills, Secretary THROUGH: John G. Mullan, General Counsel Mary T. Boyle, Executive Director DeWane Ray, Deputy Executive Director for Safety Operations FROM: Duane Boniface, Assistant Executive Director Office of Hazard Identification and Reduction Kristina M. Hatlelid, Ph.D., M.P.H., Project Manager Division of Toxicology and Risk Assessment, Directorate for Health Sciences SUBJECT : Project Plan: Organohalogen Flame Retardant Chemicals Assessment 1. Executive summary Recommendations U.S. Consumer Product Safety Commission (CPSC or Commission) staff’s plan for class- based risk assessment of organohalogen flame retardants (OFRs) includes recommendations for proceeding with a number of activities based on recommendations from the National Academy of Sciences, Engineering, and Medicine, in their report to the CPSC, “A Class Approach to Hazard Assessment of Organohalogen Flame Retardants.” These activities establish the foundation for initiating and completing risk assessments for OFR subclasses. For fiscal year 2021, CPSC requested a recurring $1.5 million above baseline appropriations in the Performance Budget Request because existing baseline appropriations are insufficient to complete this work. Thus, all plans identified below are contingent upon receiving this additional appropriation and additional appropriations in future years to continue this work. In fiscal year 2021 (FY 2021), staff will establish procedures for class-based risk assessment of OFRs, will refine the chemicals and analogs for subclasses, identify data sources, and determine available toxicity, chemical use, and exposure information. In addition, staff will begin to develop scope documents and analysis plans for defined chemical subclasses. As these CPSC Consumer Hotline and General Information: 1-800-638-CPSC (2772) CPSC's Web Site: http://www.cpsc.gov THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION UNDER CPSA 6(b)(1) documents and plans are completed for each subclass, staff will proceed with searching for relevant data and information, and begin to extract, evaluate, and integrate the data to reach decisions about the hazards, exposures, and risks of a class or to identify data gaps and additional data needs. In FY 2021, staff will establish support contracts and interagency agreements for tasks that can be performed by contractors and through interagency collaboration, and will proceed with multiple activities in parallel performed by staff, contractors, and other collaborations. Background In 2015, a number of organizations and individuals petitioned the CPSC (Petition HP 15-1) to ban the use of additive OFRs, as a class, in durable infant or toddler products, children's toys, child care articles, or other children's products (other than car seats), residential upholstered furniture, mattresses and mattress pads, and the plastic casings of electronic devices. In 2017, the Commission voted to grant the petition, to direct staff to convene a Chronic Hazard Advisory Panel (CHAP), and to complete a scoping and feasibility study in cooperation with the National Academy of Sciences, Engineering, and Medicine (NASEM). NASEM published the committee’s report, “A Class Approach to Hazard Assessment of Organohalogen Flame Retardants,” in May 2019. Process for Class-Based Risk Assessment CPSC staff’s recommended process for assessing the risks of OFRs is described in this memo and is developed by incorporating established basic principles of risk assessment for chemicals in consumer products. The process includes steps for assessing potential human health effects associated with the chemicals, evaluating exposure to the chemicals from their use in consumer products, and characterizing the risks to consumers. Staff acknowledges that the process for a class-based assessment may differ from a risk assessment for a single chemical. Staff provides an overview of the processes for assessing hazards and exposure, and for characterizing risk. Staff also provides details for specific risk assessment tasks, describes the iterative nature of risk assessments, and describes a tiered-analysis approach that can consider resource and data availability. Activities to Support Class-Based Risk Assessment CPSC staff’s approaches for inter-related technical support activities required for class-based risk assessment are described in the tabs. Tab A provides details for a class-based hazard assessment, building on the recommendations from the NASEM report. Tab B provides details for completing class-based exposure assessments. Tab C provides details for technical support activities, including examples that provide the foundation for future work. Tab D provides preliminary market-use information for certain OFR chemicals. Tab E provides a glossary of terms. 6 THIS DOCUMENT HAS NOT BEEN REVIEWED CLEARED FOR PUBLIC RELEASE OR ACCEPTED BY THE COMMISSION UNDER CPSA 6(b)(1) 2. Introduction This staff report presents background information and an analysis plan for the project on assessing hazards, exposures, and risks of organohalogen flame retardants (OFRs) in consumer products. Staff outlines key steps in the analysis plan and provides options for proceeding with the project. This memo contains a description of activities supporting class-based risk assessments for OFRs. Technical project details are located in the package tabs. 3. Background In 2015, the CPSC received a request on Consumer Products Containing Additive Organohalogen Flame Retardants. This request was docketed as Petition 15-1, under Commission procedures. The petition and related information are available online in the public docket.1 The list of petitioners included a number of organizations and individuals, such as consumer organizations, medical associations, worker, and firefighter organizations. The petition requested that the Commission ban the use of additive, non-polymeric organohalogen flame retardants under the authority of the Federal Hazardous Substances Act in the following categories of consumer products: • Durable infant or toddler products, children's toys, child care articles, or other children's products (other than car seats, which are under Department of Transportation’s jurisdiction); • Residential upholstered furniture; • Mattresses and mattress pads; and • The plastic casings of electronic devices. The petition scope included OFRs as a class. The