High Production Volume (HPV) Challenge Program

1. High Production Volume (HPV) Challenge Program Diane Sheridan Chief, Existing Chemicals Branch, Chemical Control Division, Office of Pollution Prevention and Toxics June 14, 2007

2. Topics Covered • Why the HPV Challenge Program Was Needed? • HPV Challenge Program Goals and Approach • HPV Challenge Program Design Features • HPV Challenge Commitments • How Has EPA Contributed to the HPV Challenge Program? • Next Steps • Conclusions

3. Why Was the HPV Challenge Program Needed? • Three Separate Studies • Toxic Ignorance 1997 (Environmental Defense, or ED – formerly EDF) • Data Availability Study 1998 (EPA) • Data Availability Study 1998 (American Chemistry Council, or ACC – formerly CMA)

4. Why Was the HPV Challenge Program Needed? • 43% of the U.S. HPV chemicals had no publicly available studies for any of the 6 basic endpoint groups • Only 7% of the U.S. HPV chemicals had a full set of publicly available studies for the 6 basic endpoint groups

5. HPV Challenge Program Goals and Approach • Companies asked to volunteer (“commit”) to sponsor one or more HPV chemicals • Commitment consists of identifying the sponsors and chemicals, and indicating the year the test plan and existing information will be made publicly available

6. HPV Challenge Program Goals and Approach • Participation includes developing robust summaries of scientifically adequate existing studies and a Test Plan describing what sponsors plan to do if adequate data are not available for a given endpoint • FR Notice issued December 26, 2000 (65 FR 81686)

7. HPV Challenge Program Design Features • Modeled after OECD HPV SIDS • SIDS: An agreed upon basic set of heath and environmental hazard and environmental fate information • Voluntary program for companies to make basic hazard data on their HPV chemicals publicly available by 2005 • Public involvement at every step • Incorporate animal welfare considerations and encourage use of SAR/category approaches

8. HPV Challenge Program Design Features • Screening Information Data Set (SIDS) • 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

9. HPV Challenge Program Commitments • 372 companies and 105 consortia have pledged to voluntarily provide data for approximately • 1,400 chemicals included in the U.S. Challenge Program

10. HPV Challenge Program Commitments • An additional approximately 800 chemicals are sponsored in the International Council of Chemical Associations (ICCA) HPV Initiative • Total Commitments = approximately 2,200 chemicals

11. HPV Challenge Program Commitments • As of May 31, 2007, 415 Test Plans and Robust Summaries have been submitted covering 1,416 total chemicals • 126 Test Plans are for categories • 289 Test Plans are for individual chemicals • Submissions have been received for 1,357 (98%) out of 1,387 chemicals that were sponsored directly in the HPV Challenge Program

12. Published Interim Report in December 2004 • Report Highlights • Final Status Report to Be Developed

13. How Has EPA Contributed to the HPV Challenge Program? • Availability of guidance documents such as: • Data Adequacy • Developing Robust Summaries • Developing Categories • All guidance documents can be located at:http://www.epa.gov/hpv/pubs/general/guidocs.htm • Posting of data and soliciting comments • Providing a publicly available database • High Production Volume Information System (HPVIS)

14. Next Steps EPA’s Use of HPV Data • EPA has begun to use collected program data to identify and prioritize HPV chemicals for additional data development and/or risk management actions; • Work is being done consistent with NPPTAC recommendations; • EPA will use data on HPV chemicals to support risk-based decisions, as appropriate.

15. Next Steps • Continue to Refine HPVIS Data Entry of Chemicals is ongoing effort Enhancements planned based on input from the Data Users Conference.

16. Next Steps • EPA is looking towards approaches to provide enhanced/better integrated access of other information, such as IUR exposure-related data, TRI data and additional health and safety data to stakeholders • EPA is looking to develop/provide tools to enhance the ability of broad range of stakeholders to use data - system functionality • EPA will maintain a dialogue with stakeholders through a variety of means (e.g., FOSTTA, further data use conferences) on data use issues as well as other HPV-relevant topics

17. Next Steps • EPA will continue to participate in the OECD SIDS Program and the ICCA HPV Initiative, and track those programs’ chemicals that are considered covered in the HPV Challenge Program

18. Next Steps • The OECD eChem Portal to information on chemical substances • Currently under development by OECD • Scheduled for public release this month (June 2007) • Will offer access to data and assessment reports on chemicals in commerce • Users will be offered an opportunity to comment on the format and functionality of the portal to ensure it meets the needs of diverse audiences

19. Conclusions • As a result of the HPV Challenge Program, an increasing amount of basic screening-level chemical data are now available to the public and EPA • EPA remains committed to building upon that program and enhancing its utility to all stakeholders • The Agency is beginning to utilize the data for its own mission to identify and prioritize HPV chemicals of possible concern for future management actions to protect human health and the environment

20. Conclusions • EPA looks forward to continuing to work with all stakeholders to increase access to, and understanding and utility of the data • Over the near term EPA will focus in particular on working with submitters towards “final” submissions, addressing the orphans and reporting out on progress