Polybrominated Diphenyl Ethers: Developing an EPA Action Plan

1. Polybrominated Diphenyl Ethers: Developing an EPA Action Plan Briefing for FOSTTA October 19, 2004

2. Outline • PBDEs Overview • PBDEs Exposure and Hazards • PBDEs Uses • PBDEs Status in U.S. and Europe • Key Issues for PBDEs • Developing a PBDEs Action Plan

3. PBDEs Exposure and Hazards • Rapidly growing literature on PBDEs measured in humans, wildlife, sludge and sediment, etc. • PBDEs are frequently detected • Indications of rising trends (e.g., in breast milk) • Higher levels in North America than Europe and Asia • Animal studies of various PBDE congeners and mixtures suggest a variety of potential adverse effects: • Thyroid effects and developmental neurotoxicity • Developmental reproductive effects • Anti-androgenicity

4. Uses of PBDEs • PentaBDE • Foam in furniture, mattresses, automobile seats • 8,000 tons/year worldwide; 95% used in the U.S. • OctaBDE • Plastics in electronics (e.g. TVs, computers) • 4,000 tons/year worldwide; 40% used in U.S. • DecaBDE • Plastics in electronics (e.g. TVs, computers), wire and cable insulation, textiles • 62,000 tons/year worldwide; 44% used in U.S. (industry data for 2001)

5. PBDEs Status - U.S. • Voluntary pentaBDE/octaBDE production phaseout by end of 2004 • To be “backstopped” by TSCA Significant New Use Rule • Many legislative initiatives in states, such as: • California 2006 ban on products with penta/octa • Maine law bans products containing deca by 2008 (with possible exemptions) • Federal legislation has been introduced • CPSC flammability standards - potential to increase demand for decaBDE

6. PBDEs Status - Europe • Penta/octa ban effective August 2004 • DecaBDE risk assessment “closed” • No regulatory controls at this time • But scientific study continues • DecaBDE use in electronics banned in 2006 - ? • Further clarification likely

7. Activities of Other Federal Agencies (1) • NTP • Conducting toxicology studies of commercial pentaBDE and selected congeners • CDC • Measuring U.S. body burdens of PBDEs • Sampling in 2003-04; data may be available in 2006 • NIST • Studying migration of PBDEs from plastics in electronics components

8. Activities of Other Federal Agencies (2) • CPSC • Considering furniture flammability standard - could increase use of decaBDE in furniture fabrics • OPPT coordinating re TSCA Significant New Use Rule • USDA • Methods for measuring PBDEs in meats and poultry • Research on PBDEs absorption, distribution, metabolism and elimination • FDA • Will include PBDE measurements in Total Diet Study

9. PentaBDE / OctaBDE - Key Issues • Near-term issues: • Manufacturers are evaluating and selecting replacement flame retardants this year • To guide selection of lower-risk alternatives, information on hazards/exposures of substitutes is needed • Screening-level assessment: OPPT-DfE Furniture Flame Retardancy Partnership • Longer-term issues: • Exposures to pentaBDE/octaBDE are likely to continue for decades, due to reservoirs in the environment and in products • Development of test data on substitutes needed to follow-up on screening level assessments

10. DecaBDE - Key Issues • Continuing commercial use of decaBDE • Some states are legislating restrictions • Evidence of decaBDE exposure to humans and wildlife • Additional work needed to better clarify potential risks of decaBDE • Hazard • Exposure • Environmental Fate

11. Developing an Action Plan • Workgroup with participation from across the Agency • Nature of the plan: not a detailed strategy • For release to public this Fall/Winter - providing information on EPA’s overall approach to PBDEs • Identifies Next Steps for PBDEs • What is being done in VCCEP and other programs • Additional activities that EPA believes are appropriate and necessary

12. Elements of Action Plan • Assess substitutes for penta/octa • Assessment and evaluation of decaBDE • Assessment of pentaBDE and octaBDE • Other brominated flame retardants • Additional activities as needed

13. Assessment of Substitutes for pentaBDE and octaBDE • Background: Market is in transition; industry is choosing alternatives. What are the potential risks of substitutes? • Key Activities: EPA’s Furniture Flame Retardancy Partnership is conducting a screening level hazard/exposure assessment of pentaBDE substitutes. The Partnership will define expectations for further data to be generated by manufacturers of chemicals that gain sufficient market share as pentaBDE replacements.

14. Assessment and Evaluation of Decabromodiphenyl Ether (decaBDE) • Background: Use of decaBDE continues. Key issues include risk from decaBDE itself and its contribution to formation of lower-brominated breakdown products. • Key Activities: • If CPSC proposes a furniture flammability standard (increasing demand for decaBDE), EPA will propose a TSCA SNUR that will enable EPA to review decaBDE (and other flame retardants) in this use before use begins • IRIS review of decaBDE toxicology – completion by late 2005 • Seek additional needed data on decaBDE • EPA recommendations to VCCEP sponsors forthcoming shortly

15. Assessment of pentaBDE and octaBDE • Background: Voluntary phaseout of US production of pentaBDE and octaBDE by end of 2004; stocks are stored in existing products. • Key Activities: • EPA will propose a TSCA SNUR in Fall 2004, enabling EPA to receive advance notification of plans to manufacture or import pentaBDE or octaBDE. • EPA is conducting IRIS reviews for tetra-, penta-, hexa- and octaBDE congeners - completion is projected for late 2005. • Seek additional needed data on pentaBDE/octaBDE • EPA recommendations to VCCEP sponsor forthcoming shortly

16. Other Brominated Flame Retardants of Interest • Background: PBDEs are not the only BFRs of potential interest. • Key Activities: • EPA will review scientific developments on other brominated flame retardants, and will engage in further research, risk assessment and risk management as the need develops. • EPA will continue to scrutinize new flame retardants proposed for manufacture and import into the U.S. market and, where appropriate, will seek development of additional data on such chemicals by their manufacturers under TSCA Section 5 authorities.

17. Additional Activities as Needed • EPA will consider additional activities, beyond those identified in the Action Plan, as needed. Additional activities could include: • Information gathering for other flame retardant chemicals; • Obtaining further data on potential, releases, exposures, hazards and risks for PBDEs; • Developing guidance on advisories for PBDEs in fish; • Taking actions to mitigate risks that may result from the continuing release of pentaBDE and octaBDE from existing products, and risks associated with decaBDE.

18. Next Steps • Complete drafting of Action Plan • Public release of plan – by Fall/Winter?