1. EPA’s Existing Chemicals Programs and Initiatives Presented to the North and South Carolina Chapter American Industrial Hygiene Association Charles Auer, Director, Chemical Control Division March 15, 2002

2. Why is the HPV Challenge Needed? 43% of the U.S. HPV chemicals have no publicly available studies for any of the 6 basic endpoints Only 7% of the U.S. HPV chemicals have a full set of publicly available studies for the 6 basic endpoints

3. HPV Challenge Program Goals and Approach l HPV Challenge goal is public availability of a baseline set of health and environmental effects data on approximately 2800 HPV chemicals; goal is not testing chemicals l Defined list of chemicals and battery of tests – Screening Information Data Set (SIDS) l Submit detailed summary information in a uniform database format (“robust summaries”) l FR Notice issued December 26, 2000 (65 FR 81686)

4. HPV Challenge Program Design Features l Voluntary program for companies to make basic hazard data on their HPV chemicals publicly available by 2005 l Strongly encourage greater international testing efforts under OECD HPV/SIDS, ICCA l Public involvement at every step l Incorporate animal welfare considerations and encourage use of SAR/category approach

5. SIDS Data Elements l Chemical Identity Chemical Name CAS Registry Number l Physical/Chemical Properties Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility

6. SIDS Data Elements (cont.) l Environmental Fate and Pathways Biodegradation  Aerobic Abiotic Degradability  Hydrolysis  Photolysis l Fate and Environmental Distribution Assessment

7. SIDS Data Elements (cont.) l Ecotoxicity Acute Toxicity  Fish  Daphnia  Algae Chronic Toxicity (when indicated)  Daphnia

8. SIDS Data Elements (cont.) l Mammalian Toxicity Acute Toxicity  Oral preferred if not available (except for gases) Repeated Dose Toxicity  Combined Repeat Dose and Reprotox Screen (OECD 422) OR  28-day study (OECD 407)

9. SIDS Data Elements (cont.) l Mammalian Toxicity (Con’t) Genotoxicity  Gene mutation  Chromosomal aberrations Reproductive/Developmental Toxicity  Combined Reproductive and Developmental Toxicity Screen (OECD 420) OR  Combined Repeat Dose and Reprotox Screen (OECD 422)

10. SIDS Data Elements (cont.) l Report Other Available Hazard/Exposure Data - the OECD SIDS “Dossier” includes reporting for: Irritation Sensitization Carcinogenicity Other physical/chemical properties Human Experience Exposure/Use Information Etc.

11. HPV Challenge Program Success 423 companies and 131 consortia have pledged to voluntarily provide data on over 2100 chemicals by 2005!

12. HPV Challenge Program l Companies now submitting test plans and robust summaries of existing data l Data are publicly accessible through posting on Internet: – www.epa.gov/chemrtk www.epa.gov/chemrtk

13. HPV Challenge Program l Companies exploring voluntary submission of exposure data to provide context for hazard data. l Companies should delay start of new testing for 120 days after posting of test plan to allow public comment.

14. Test Plan Performance l 121 Test Plans covering 776 chemicals have been received by EPA. Test Plans cover 65 chemical categories and 56 single chemicals l 116 Test Plans have been posted on EPA’s web site for public comment l Test Plans are generally being sent to EPA on the schedule committed to by the sponsors. l Test rule to ensure equity ( 65 FR 81658)

15. Why the HPV Challenge Program is Important to Your Work? By 2005 :  basic information available to industry, government and the public on all HPVchemicals.  fully searchable database.  as data are assessed, priority chemicals are identified for additional testing, assessment, or management.

16. Why is the Voluntary Children’s Chemical Evaluation Program (VCCEP) Needed? “... review and report on what new testing may be needed to address the special impact industrial chemicals may have on children.”

17. l VCCEP developed via a public stakeholder process. l VCCEP is not a testing program – hazards, exposures, and risks of chemicals to children are evaluated and if necessary information gaps are to be filled. l FR Notice announcing the “Voluntary Children’s Chemical Evaluation Program” issued December 26, 2000 (65 FR 81699). l The Pilot attempts to define a workable common ground that meets the needs of diverse stakeholders.

18. Key Features of the VCCEP l Goal is publicly available data. l Strong chemical selection criteria – biomonitoring data. l Tiered testing scheme. l Implementation process builds on and models the HPV Challenge when ever possible. l Commitments made tier by tier in the Pilot.

19. Key Features of the VCCEP (cont.) l Role for exposure information gathering and assessment. l Additional data development decisions (such as testing) based on whether chemical is adequately characterized given the available data. l Peer Consultation promotes joint stewardship of the program and a strong science foundation.

20. 23 Pilot Chemicals AcetoneToluene Benzene[Chlorobenzene] Vinylidene chloriden-Dodecane Methyl ethyl ketonep-Dioxane TrichloroethyleneDecane alpha-PineneTetrachloroethylene o-Xylene[m-Dichlorobenzene] EthylbenzeneUndecane p-DichlorobenzeneDecabromodiphenylether [Ethylene dibromide] Pentabromodiphenyl ether Ethylene dichloride Octabromodiphenyl ether m-Xylene [ ] = unsponsored

21. 1 st Tier Toxicity Studies (HPV Challenge Health-related Studies) l Acute toxicity l Repeated dose toxicity with reproductive and developmental toxicity screens l Bacterial reverse mutation assay l In vitro or in vivo chromosomal aberrations

22. 2 nd Tier Toxicity Studies l Sub chronic (90 day) toxicity l Prenatal developmental toxicity l Reproductive and fertility effects l Metabolism and pharmacokinetics l Immunotoxicity l In vivo chromosomal aberrations or in vivo micronucleus test

23. 3rd Tier Toxicity Studies l Carcinogenicity l Neurotoxicity screening battery l Developmental neurotoxicity

24. Exposure Assessments l Biomonitoring data used for chemical selection contribute to an overall assessment. l Depth of exposure information increases with each tier: – Tier 1: screening level data – Tiers 2 and 3: advanced assessments using exposure studies, monitoring data, and modeling l Transparency l Exposure assessments need to address standard issues: – Populations – Routes of exposure – Extent, duration and frequency of exposures

25. Peer Consultation l Forum for scientists and experts from stakeholder groups to exchange scientific views on sponsor’s assessments. l Hoping for participation by State experts. l Not a consensus based approach. l Managed by an independent third party that summarizes the consultation’s results and forwards them to EPA. l Balanced science-based participation. l First Peer Consultation for Tier 1 assessments anticipated mid-2002

26. Participation l Tremendous support from chemical manufacturers l 20 of 23 chemicals sponsored l Over 35 sponsor companies l 11 consortia (some sponsor multiple chemicals)

27. Why is VCCEP Important to Your Work? l Complements HPV Challenge with detailed testing and assessment. l Ability to develop key exposure data. l Peer consultation may provide effective new way of working.

28. Information Access For more information about HPV and VCCEP and its pilot (including past Federal Register Notices, HPV Test Plan Review information, VCCEP Peer Consultation information, guidance materials and other technical materials) see: www.epa.gov/chemrtk

29. PerFluoroOctyl Sulfonates (PFOS) and Related Chemicals & PerFluoroOctyl Sulfonates; acids, salts, halides,etc. & Over 300 chemicals, including polymers. & Man-made: do not occur in nature. & Produced since 1950’s for use in surface treatment, paper protection, and performance chemical (surfactant and insecticide) products.

30. PFOS Concerns l Persistent: –Very stable chemical that does not break down or degrade in the environment; once it’s there, it stays l Bioaccumulative: –PFOS can build up over time; its half-life in human blood may be from 1 to 4 years –Organisms higher-up in the food chain are exposed to the full dose of what has built up in their food

31. PFOS Concerns l Toxic: - In repeat dose systemic and reproductive toxicity studies, serious effects seen » Post-natal deaths in rats at 3.2 and 1.6 mg/kg/day » In repeat-dose treated Rhesus monkeys, death within 3 weeks at 10 mg/kg/day; within 7 weeks at 4.5 mg/kg/day. Adverse effects in cynomolgus monkeys at 0.75 mg/kg/day

32. PFOS Concerns l Exposure: Detected in blood not only in workers handling the chemical, but in the general US population and in wildlife worldwide – High as 12.83 ppm in manufacturing workers – In pooled serum from general population, 30-40 ppb; small sample of children, mean 54 ppb – In birds, wild mammals, and fish, in ppb range

33. PFOS Withdrawal Strategy l 3M Corporation conducted studies, shared results with EPA, and discussed concerns. l In May, 3M publicly announced voluntary phase-out of perfluorooctanyl chemistries, most by end of 2000, others by end of 2002. l 3M continues aggressive research program. l EPA followed up voluntary action with regulation.

34. PFOS Withdrawal Strategy l EPA proposed and took public comment on a Significant New Use Rule (SNUR) to manage 90 PFOS chemicals discontinued by 3M l Public meeting on March 27, 2001, raised clarification questions, more information provided from several industry sectors through October 2001 l Follow-up actions published in the Federal Register Monday, March 11, 2002

35. Follow Up Actions  Final SNUR 67 FR 11008 concerns 13 known discontinued PFOS chemicals making any new manufacture or importation a significant new use; and & Supplemental Proposed Rule 67 FR 11014 includes 75 additional chemicals, proposing to exclude from the definition of “significant new use” specifically defined, low volume, controlled exposure uses in: semiconductor manufacture; aviation hydraulics; photography;

36. Related Chemistry Concerns  PFOA and related substitutes, such as fluorinated “telomers”, may present similar concerns: –Known persistence. –Evidence of toxicity data in public literature. –PFOA also found in human blood, although at lower levels than PFOS &EPA working with industry to answer key questions and develop comprehensive database –PFOA: similar bioaccumulative potential? fate and transport? –similar widespread exposure? Toxicity? –Telomers: fate and transport? similar widespread exposure? Toxicity? what degradates are formed from the telomers? What is the degradates bioaccumulation potential?

37. Ongoing EPA Actions l PFOS: –Complete action on proposed SNUR for 88 3M phaseout PFOS chemicals. –Consider need/options for action on other 200-plus PFOS chemicals. l PFOA: –Preliminary hazard assessment released March 2002 –Assess new data as received. –Identify needs/options for action.

38. Ongoing EPA Actions l Telomers: –Begin EPA review of existing data. –Review submissions from voluntary industry testing program in 2001-2002. –Address existing, as yet unsubstantiated market claims that telomerization products are safer than fluorochemicals produced through other processes.

39. State, Tribal, and Local Challenges- Why PFOS Issue is Important to You? l Hazard assessment outcomes on fluorochemicals may influence future discharge and permitting decisions at manufacturing plants and facilities. l Changes in fire fighting foam formulations over the next 10 years may affect municipal, tribal, and volunteer fire departments using synthetic foams (different foam types require different equipment). l Alternatives will be developed to meet the many other uses of PFOS: What is their safety and effectiveness?

40. For Further Information on PFAS l Staff Technical Contact: Mary F. Dominiak, 202-564-8104, dominiak.mary@epa.gov dominiak.mary@epa.gov l For data CDs from PFOS/PFOA/telomer file (AR-226), or for copies of comments on SNUR (OPPTS-50639): TSCA NCIC, 202-260-7099, Monday-Friday, noon to 16:00 Eastern time; oppt.ncic@epa.govoppt.ncic@epa.gov