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U.S. High Production Volume (HPV) Challenge Program

U.S. High Production Volume (HPV) Challenge Program. Diane Sheridan U.S. Environmental Protection Agency October 25, 2005 Region 2 Emerging Chemicals Workshop. HPV Challenge Program Topics. History How the Program Works Data Submissions HPV Information System Outreach. History.

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U.S. High Production Volume (HPV) Challenge Program

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  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. HPV Challenge Program Topics • History • How the Program Works • Data Submissions • HPV Information System • Outreach 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) Region 2 Emerging Chemicals Workshop

  4. HPV Challenge ProgramGoals 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) Region 2 Emerging Chemicals Workshop

  5. HPV Challenge ProgramDesign 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 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 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 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) 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 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 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 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 Region 2 Emerging Chemicals Workshop

  13. Existing Data Region 2 Emerging Chemicals Workshop

  14. HPV Challenge Program Timeline Region 2 Emerging Chemicals Workshop

  15. “Orphan” Chemicals • 289 unsponsored (aka “orphan”) chemicals 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 Region 2 Emerging Chemicals Workshop

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

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