1. U.S. High Production Volume (HPV) Challenge Program Diane Sheridan U.S. Environmental Protection Agency October 25, 2005 Region 2 Emerging Chemicals Workshop

2. October 25, 2005 Region 2 Emerging Chemicals Workshop 2 HPV Challenge Program Topics History How the Program Works Data Submissions HPV Information System Outreach

3. October 25, 2005 Region 2 Emerging Chemicals Workshop 3 History Earth Day 1998: then-VP Gore announces collaborative effort – Industry, environmental groups, and government 3 studies show lack of HPV data: – Toxic Ignorance, 1997 (Environmental Defense, or ED) – Data Availability Study, 1998 (American Chemistry Council, or ACC) – Chemical Hazard Data Availability Study, 1998 (EPA)

4. October 25, 2005 Region 2 Emerging Chemicals Workshop 4 HPV Challenge Program Goals and Approach 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 Defined list of chemicals and battery of tests – Screening Information Data Set (SIDS) Submit detailed summary information in robust summary format. December 26, 2000 (65 FR 81686)

5. October 25, 2005 Region 2 Emerging Chemicals Workshop 5 HPV Challenge Program Design Features Voluntary program for companies to make basic hazard data on their HPV chemicals publicly available by 2005 Strongly encourage greater international testing efforts under OECD HPV/SIDS, ICCA Public involvement at every step Incorporate animal welfare considerations and encourage use of SAR/category approach 2 Components – Voluntary and Regulatory

6. October 25, 2005 Region 2 Emerging Chemicals Workshop 6 Data Types SIDS Data Set – (1) acute toxicity – (2) repeat dose toxicity – (3) developmental & reproductive toxicity – (4) mutagenicity – (5) ecotoxicity – (6) environmental fate

7. October 25, 2005 Region 2 Emerging Chemicals Workshop 7 Screening Information Data Set (SIDS) Elements Physicochemical properties: melting & boiling pts., vapor pressure, water solubility, partition coeff. Environmental fate: photodegradation, stability in water, biodegradation, transport (model) Environmental effects: acute toxicity in fish, aquatic invertebrates and aquatic plants Health effects: acute and subchronic toxicity, genetic toxicity, reproductive and developmental toxicity

8. October 25, 2005 Region 2 Emerging Chemicals Workshop 8 Sponsorship 2,252 sponsored – 1,398 directly in the program – 854 indirectly through the International Council of Chemical Associations (ICCA)

9. October 25, 2005 Region 2 Emerging Chemicals Workshop 9 Data Submissions 376 test plans with robust summaries Cover 1,313 of the 1,398 (94%) chemicals Robust Summaries and Test Plans webpage: http://www.epa.gov/chemrtk/viewsrch.htm

10. October 25, 2005 Region 2 Emerging Chemicals Workshop 10 Public Comments Test Plan posted, then 120-day comment period Industry, environmental protection groups, animal welfare groups, universities, private citizens, etc. -- may comment Provided Comments – Environmental Defense: 89% – PETA and PCRM: 62% – Other: 3% – EPA: must comment on 100% of materials

11. October 25, 2005 Region 2 Emerging Chemicals Workshop 11 Chemical Categories Category = “group of substances similar in chemical structure that show a regular pattern of properties and effects; where not every endpoint needs to be tested” Benefits: – reduced animal testing – $$ saved – time saved 81% of chemicals in a category

12. October 25, 2005 Region 2 Emerging Chemicals Workshop 12 Guidance Documents EPA provides clear guidance to assist stakeholders in participating in the Program Guidance provided for subjects such as: – category formation – developing robust data summaries – assessing adequacy of existing data http://www.epa.gov/chemrtk/guidocs.htm

13. October 25, 2005 Region 2 Emerging Chemicals Workshop 13 Existing Data

14. October 25, 2005 Region 2 Emerging Chemicals Workshop 14 HPV Challenge Program Timeline

15. October 25, 2005 Region 2 Emerging Chemicals Workshop 15 “Orphan” Chemicals 289 unsponsored (aka “orphan”) chemicals

16. October 25, 2005 Region 2 Emerging Chemicals Workshop 16 Orphans Accepting new commitments to chemicals until approximately next month’s: – TSCA Section 8(a) Preliminary Assessment and Information Reporting (PAIR) rule, and – TSCA Section 8(d) Health and Safety Data Reporting (HaSDR) rule New commitments after those rules’ effective date will require submission of health and safety studies. TSCA Section 4 Test Rules = regulatory mechanisms to secure data

17. October 25, 2005 Region 2 Emerging Chemicals Workshop 17 HPVIS HPV Information System (HPVIS) Sophisticated data-searchable web application Release scheduled by end of 2005

18. October 25, 2005 Region 2 Emerging Chemicals Workshop 18 HPVIS Search for specific endpoint data or other data related to a specific chemical – E.g., ecotoxicity of nitroglycerine to flathead minnow in range of mg/L Audience: generally technical

19. October 25, 2005 Region 2 Emerging Chemicals Workshop 19 National HPV Data Users Conference Late Fall 2006 3 Days Audience – EPA Regions – EPA HQ – State technical health and environmental personnel – Academia – NPPTAC members – Consumers – NGOs – Industry

20. October 25, 2005 Region 2 Emerging Chemicals Workshop 20 Data Users Conference Purpose – Familiarize participants with the HPV Challenge Program – Communicate capabilities of the HPVIS and how the database is used – Encourage HPVIS use by states and others – Show what information can and can not be gleaned from HPV data – Useful links to other databases; i.e., TRI, that might contain additional information on some HPV chemicals

21. October 25, 2005 Region 2 Emerging Chemicals Workshop 21 NPPTAC National Pollution Prevention and Toxics Advisory Committee (NPPTAC) and NPPTAC’s HPV Work Group Working together to develop a screening approach for identifying and prioritizing chemicals for further work

22. October 25, 2005 Region 2 Emerging Chemicals Workshop 22 Emerging HPVs ACC/SOCMA/SDA created the Emerging HPV (EHPV) Program of 573 chemicals that are HPV in 2002 IUR EPA input, but run by private industry

23. October 25, 2005 Region 2 Emerging Chemicals Workshop 23 Future of EPA HPV Programs? Will EPA have its own program for recently emerging HPV chemicals? EPA Regions can be involved – Communicate with chemical manufacturers in your region

24. October 25, 2005 Region 2 Emerging Chemicals Workshop 24 HPV Challenge Program Homepage: http://www.epa.gov/chemrtk/volchall.htm Diane Sheridan Sheridan.Diane@epa.gov (202)-564-8176