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

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

Environmental Protection Agency 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.

Environmental Protection Agency 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.

Environmental Protection Agency 5 Sponsorship 2,243 (out of 2,800) HPV chemicals sponsored: 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: sponsor companies sponsor consortia (groups of companies)

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

Environmental Protection Agency 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.

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

Environmental Protection Agency 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.

Environmental Protection Agency 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.

Environmental Protection Agency 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.

Environmental Protection Agency 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 )

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

Environmental Protection Agency 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

Environmental Protection Agency 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

Environmental Protection Agency 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

Environmental Protection Agency 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

Environmental Protection Agency 18 Public View No registration required Standard and ad hoc queries and reports Entry via links on EPA website

Environmental Protection Agency 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)

Environmental Protection Agency 20 Demonstration Public access version using the EPA website: Standard Query across submissions using name or CAS # or fragment. - Endpoint data & information - Ad hoc querying function –using own values for search.

Environmental Protection Agency 21 Questions?? HPVIS Website: HPV Challenge Program website: Questions about HPVIS: Todd Holderman Gloria Drayton-Miller

Environmental Protection Agency 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

Environmental Protection Agency 23 QUESTIONS?