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- Need For HPV Chemical Data Collection
- Creation of the HPV Challenge Program
- Voluntary Chemical Sponsorships to Collect HPV Chemical Data
- Success of Voluntary Chemical Sponsorships
- Regulatory Efforts to Collect Data for Unsponsored Chemicals
- Public Access and Use of Collected HPV Chemical Data
- EPA Review and Use of HPV Chemical Data
This site contains archived information outlining the origins of the HPV Challenge Program, which includes documents describing the voluntary chemical sponsorship portion of the program that is now closed. This archived information is no longer actively used or updated by the Agency and is indicated by this symbol . Archived information remains on the site as a useful reference. Data submitted to the HPV Challenge Program are being reviewed and incorporated into the Agency's enhanced existing chemicals management activities.
Under the High Production Volume (HPV) Challenge Program, companies were "challenged" to make health and environmental effects data publicly available on chemicals produced or imported in the United States in the greatest quantities. HPV chemicals are classified as those chemicals produced or imported in the United States in quantities of 1 million pounds or more per year. As of June 2007, companies sponsored more than 2,200 HPV chemicals, with approximately 1,400 chemicals sponsored directly through the HPV Challenge Program and over 860 chemicals sponsored indirectly through international efforts.
Access to HPV chemical information enables the public to participate in environmental decision-making at all levels - federal, state, and local. With the scheduled voluntary submission of data to the HPV Challenge Program now complete, the focus has shifted to data use, both by the public and by EPA in its mission to protect human health and the environment.
Need For HPV Chemical Data Collection
In 1998, multiple studies (including EPA's Chemical Hazard Data Availability Study) confirmed that there were significant gaps in the basic data needed to understand and characterize the potential hazards associated with HPV chemicals. A lack of information could mean that people are unaware of potential risks to humans and the environment that are associated with HPV chemicals.
Creation of the HPV Challenge Program
EPA, Environmental Defense (ED), American Petroleum Institute (API), and American Chemistry Council (ACC) joined forces to launch the HPV Challenge Program in 1998 in order to collect basic hazard data for HPV Chemicals. The goal of the HPV Challenge Program was to collect health and environmental effects data to provide the public with basic hazard information regarding HPV chemicals that would allow them to actively participate in environmental decision-making at all levels – local, state and federal. Collection of HPV chemical data would also provide EPA with valuable hazard information to support its mission of protecting human health and the environment.
Voluntary Chemical Sponsorships to Collect HPV Chemical Data
In the HPV Challenge Program, chemical manufacturers and importers agreed to "sponsor" and collect basic hazard data for HPV chemicals. A set of operating principles provided the framework for sponsor development and submission of data for HPV chemicals. Specifically, companies voluntarily provided basic data on HPV chemicals, which included physical-chemical properties, and health and environmental effects information. EPA encouraged the submission of existing data to minimize the need for additional testing. Where the chemical sponsor determined that data needed to be developed, the sponsor submitted a test plan to fill data gaps.
EPA posted the test plans for public comment and provided Agency feedback on the adequacy of the plan. Technical guidance documents were developed as an aid for collecting the appropriate data and conducting necessary tests. Once a sponsor's plan was reviewed, the testing phase began. Final test results were submitted to EPA when testing was complete, and full chemical data sets were made publicly available.
Success of Voluntary Chemical Sponsorships
The voluntary initiative to collect chemical data has been a success with companies sponsoring over 2,200 chemicals (Sponsored Chemicals List). Approximately 1,400 chemicals were sponsored directly through the HPV Challenge Program and over 860 chemicals were sponsored indirectly through the International Council of Chemical Associations (ICCA) HPV Initiative . Sponsorship commitments came from individual companies and groups of companies that joined together in more than 100 consortia to work cooperatively to make hazard information publicly available (Organizations Sponsoring HPV Chemicals).
As a result of the HPV Challenge Program, a significant amount of existing and previously unpublished health and environmental data has been made publicly available by companies participating in the program. The submission of existing data included approximately 6,500 published studies and over 8,100 previously unpublished studies. The remainder of data for HPV chemicals was supplied through new testing by sponsors. All of this newly collected data allows HPV chemicals to become more widely understood by the Agency, stakeholders, and, most importantly, the public, who now have access to meaningful information on these chemicals. For a detailed discussion of the voluntary program and its successes, please see the Status and Future Directions of the High Production Volume Challenge Program report.
Regulatory Efforts to Collect Data for Unsponsored Chemicals
While a large amount of data was collected through voluntary chemical sponsorships, other chemicals remained unsponsored in the HPV Challenge Program. Therefore, EPA is collecting basic hazard data for these unsponsored chemicals (7 pp., 71 KB, About PDF) through regulatory efforts. Toxic Substances Control Act (TSCA) section 4 test rules and section 8(a)/8(d) rules have been issued by EPA to gather this much needed data.
Public Access and Use of Collected HPV Chemical Data
The public and other interested parties can access chemical data submitted to the HPV Challenge Program on the Robust Summaries and Test Plans page on this Web site or using the High Production Volume Information System (HPVIS). EPA is assisting the public and other stakeholders in determining ways to use this hazard data in their own assessment of the potential risks associated with these chemicals.
EPA Review and Use of HPV Chemical Data
Data submitted to the HPV Challenge Program are being reviewed and incorporated into chemical evaluations used in the Agency's enhanced existing chemicals management program to prioritize chemicals to indicate whether additional data or control measures may be needed to address potential hazards and risks.