The High Production Volume Information System (HPVIS)

1. The High Production Volume Information System(HPVIS) Demonstration and Status National Environmental Partnership Summit

2. Presentation Overview • Background and History: HPV Challenge Program • Data population activities • Public Release • Levels of user access • Public • Sponsor • EPA • Next steps • Demonstration

3. HPV Challenge Program - History 3 separate studies showed lack of HPV data: Environmental Defense (1997), American Chemistry Council (1998) and EPA (1998) All 3 studies concluded: Most HPVs do not have basic hazard information that is available to the public.” The HPV Challenge Program began in 1998 as a collaborative effort between EPA, ACC, API and ED. Goal: To make basic health and environmental effects data for HPV chemicals available to the public by the end of 2005.

4. Program Structure • 1990 Inventory Update Rule (IUR) reporting records showing 2,800 HPV chemicals – basis for program. • Manufacturers commit to “sponsor” these chemicals • Sponsor submit: • test plans to fill data gaps • robust or data summaries • Materials are posted to the HPV Challenge program website • a 120 day comment period begins for all stakeholders • TSCA rulemaking to fill data gaps not addressed.

5. Sponsorship • 2,243 (out of 2,800) HPV chemicals sponsored: - 861 indirectly through the International Council of Chemical Associations (ICCA) HPV Initiative - 1, 382 directly in the HPV Challenge Program - Direct sponsorship entails that EPA will review, post, and analyze approx 1,400 chemicals. • Extensive Participation To Date: - 370 sponsor companies - 103 sponsor consortia (groups of companies)

6. Submissions • 394 test plan & data summary submissions to date: - 273 for individual chemicals - 121 for categories of chemicals (average 9 chemicals/category) • Test plans & data summaries submitted for 1,335 (97%) of the 1,382 sponsored chemicals.

7. Overdue Chemicals • Although all data was to be submitted by December 2005, 47 chemicals are “overdue” or delinquent • Additional data continues to be received.

8. “Orphan Chemicals” • 286 unsponsored chemicals • TSCA Rulemaking Efforts to Address Orphans: Test Rules= TSCA Section 4(a)(1)(B) - 1st Proposed HPV Test Rule: 37 chemicals (December 26, 2000) - 1st Final HPV Test Rule: 17 chemicals (March ’06) • 2nd Proposed HPV Test Rule: Approx. 50 chemicals under development (March 2007)

9. “Orphan” Chemicals • TSCA Section 8 Rules - Remaining chemicals will have 8a/8d rules issued (Spring 2006) - TSCA Section 8(a) Preliminary Assessment and Information Reporting (PAIR) Rule. - TSCA Section 8(d) Health and Safety Data Reporting (HaSDR) Rule • All rules are designed to secure data for orphan chemicals.

10. Extended HPV Program • The ACC, in cooperation with the Soap and Detergent Association (SDA) and Synthetic Organic Chemical Manufacturers Association (SOCMA), have announced the Extended HPV Program (EHPV Program) • Includes 573 chemicals that are HPV on the 2002 Inventory Update Rule (IUR) but were not included in the HPV Challenge Program. • ACC is tracking commitments • Exposure information is a component of the program.

11. HPV Information System (HPVIS) • A searchable web application that provides the public with comprehensive and easy access to critical information on HPV chemicals • Users will be able to search for technical chemical property data that was submitted to the HPV Challenge Program. • HPVIS was released to the public on April 16, 2006.

12. System Status Current Activities • Legacy Data Population • Data entry of sponsor-submitted submissions by contractors • Contractors perform quality control • Sponsor data verification • Outreach to various user communities and stakeholder groups • Collection of requirements for enhanced reporting capabilities)

13. Data Population • HPVIS made available to sponsors for direct data entry • IUCLID conversions in progress as files are received

14. Initial Public Release of HPVIS • Not all legacy data is available at this time. • Currently available data includes: • Approximately 225 Submissions of 574 Sponsored Chemicals • About 400 of these Chemicals from Category Submissions

15. Levels of User Access • Depending on who is using the system, HPVIS provides 3 views of the system, each with unique functionality and features: • Sponsor View • EPA View • Public View

16. Sponsor View • ID and password controlled • Sponsor creates submission • Data Entry Screens • Ability to manage and save “in progress” submissions prior to sending to EPA • Exclusive access to submissions prior to sending to EPA • Sponsor validation only if EPA-entered legacy data

17. EPA Review • ID and password controlled • Review process • Review suggested changes from sponsor validation process • Content review (create EPA comments) • Manage and track EPA review process workflow

18. Public View • No registration required • Standard and ad hoc queries and reports • Entry via links on EPA website

19. Next Steps • Continue to resolve any requirements or functionality issues as additional users begin to utilize HPVIS • Continue to engage internal EPA and external stakeholders to gather feedback on reporting and query needs • Evaluate additional reporting needs and suggested changes to system functionality for potential enhancements to HPVIS • Posting while concurrently allowing validation (3 weeks)

20. Demonstration • Public access version using the EPA website: www.epa.gov/hpvis - Standard Query across submissions using name or CAS # or fragment. - Endpoint data & information - Ad hoc querying function –using own values for search.

21. Questions?? • HPVIS Website: www.epa.gov/hpvis • HPV Challenge Program website: www.epa.gov/hpv • Questions about HPVIS: • Todd Holderman 202-564-8597 holderman.todd@epa.gov • Gloria Drayton-Miller 202-564-8619 drayton-miller.gloria@epa.gov

22. CONFERENCE FOR HPV DATA USERS • “Characterizing Chemicals in Commerce: Using Data on High Production Volume (HPV) Chemicals” – First U.S. Conference • Radisson Inn, Austin, Texas • December 12-14, 2006

23. QUESTIONS?