1. Phasing Out PFOS and PBDEs: Voluntary and Regulatory Steps Kenneth Moss Chemical Control Division Office of Pollution Prevention and Toxics, EPA HQ October 25, 2005 EPA Region 2

2. Overall Process Identifying the Problem Voluntary Phase Out Regulatory Follow Up New Chemicals Program coordination

3. Case Study Chemicals Perfluorooctyl sulfonates (PFOS): persistent manmade chemicals used extensively since the 1950’s in protective coatings and surfactants. Polybrominated diphenyl ethers (PBDEs) in use since the 1970’s, in furniture foam and plastics for electronics.

4. Identifying the Problem: PFOS Data submitted in late 1990’s on PFOS under TSCA §8(e) indicated unanticipated toxicity and unusual bioaccumulative potential Reproductive toxicity in rats; systemic toxicity in monkeys Not stored in fat; apparently bonds to blood proteins and remains in enterohepatic circulation, half-life in humans estimated at 4 years or more

5. Identifying the Problem: PBDEs Environmental studies indicated presence of PBDEs in biota, including human breast milk and serum Existing hazard and exposure information was incomplete Need to balance fire safety benefits of PBDEs with environmental issues

6. Identifying the Problem: PBDEs Neurodevelopmental toxicity, endocrine disruption, cancer, immunotoxicity, liver effects, disruption of thyroid hormone levels, and developmental toxicity concerns identified, but significance uncertain. Concerns tend to be higher for the lower brominated PBDEs.

7. Voluntary Phase Out: PFOS Recognizing the concerns, the PFOS manufacturer (3M) and EPA held discussions regarding the 8(e) information In May 2000, 3M announced voluntary withdrawal from market by end of 2002

8. Voluntary Phase Out: PBDEs EPA began discussions with the manufacturers of brominated flame retardants, including Great Lakes Chemical Co., in the late 1990's as part of our efforts to address persistent, bioaccumulative and toxic (PBT) chemicals and as we initiated the Voluntary Children’s Chemical Evaluation Program (VCCEP).

9. Voluntary Phase Out: PBDEs These discussions, along with other international and State actions on octa and pentaBDE, led the company to Commit to sponsor both chemicals under the VCCEP (in 2002) Announce (in 2003) phase out by end of 2004

10. Regulatory Follow-Up: Significant New Use Rules (SNUR) EPA’s authority to issue SNURs comes from TSCA section 5(a)(2) SNURs require notification to EPA 90 days in advance of commercialization of a chemical for a “significant new use” When a notice is submitted, EPA can take action to limit or prohibit the new use, in much the same way as it does for new chemicals

11. Regulatory Follow-Up: PFOS In Oct. 2000, EPA proposed a Significant New Use Rule (SNUR) under TSCA §5(a) to restrict all new U.S. manufacture or importation of PFOS chemicals in 3M phase-out Chemicals included intermediates critical to the manufacture of other PFOS chemicals on TSCA Inventory

12. Regulatory Follow-Up: PFOS In March and Dec. 2002, EPA finalized SNURs on 88 PFOS chemicals, requiring prior notice to the Agency for all manufacture or import except for specifically limited uses in: Aviation hydraulic fluid Photomicrolithography (semiconductors) Specific imaging uses Excepted uses characterized by low volume, low release, and no available substitutes

13. Regulatory Follow-Up: PBDEs EPA proposed SNUR in December 2004 to require notification prior to restarted manufacture or import, for any use, of Penta- or OctaBDE (and other congeners) after January 1, 2005 (phase out date). Final rule expected this December.

14. Other Voluntary Efforts on PBDEs EPA’s Voluntary Children’s Chemical Evaluation Program (VCCEP) – August 2005 Data Needs Decision on PBDEs. EPA Region 9 conferences on BFRs and electronics, September, 2002; and BFRs and foam, April, 2003. DfE Furniture Flammability Partnership: http://www.epa.gov/dfe/projects/flameret/

15. TSCA New Chemicals Program Positioned to evaluate substitutes for PBDEs and PFOS Designed to prevent health and/or environmental risks before they occur Regulatory decisions are often made in the absence of data Hazard and exposure screening models Structure Activity Relationships

16. Coordination between new and existing chemicals: PFOS New Chemicals Program applied data from Existing Chemicals to reviews of PMN and LVE chemicals containing or derived from PFOS. As Existing Chemicals review expanded to address related chemicals, including PFOA, fluorinated telomers, and other perfluoroalkyl sulfonates, New Chemicals reviews kept pace.

17. Coordination between new and existing chemicals: PBDEs Since 1979, over 150 Premanufacture Notices (PMNs) submitted for new PBDE replacement flame retardant chemicals, including BFRs Design and schedule of phase out plan on pentaBDE impacted by EPA decision on new chemical substitute – Firemaster 500.

18. Coordinating with Activities of Other Federal Agencies NTP: toxicology studies CDC: U.S. body burdens NIST: migration (PBDEs) from plastics USDA/FDA: (PBDEs) in meats and poultry, feed