Summary
The ACA Position
The Genesis of the Program
The Framework Agreement
The Status of Testing
Industry Consortia
The Internet Tracking System

Summary

Members of the Alliance for Chemical Awareness (ACA) and other groups, the U.S. Environmental Protection Agency (EPA), and Environmental Defense (ED) have agreed on a plan to increase the amount of publicly available screening-level hazard information on high production volume (HPV) chemicals. HPV chemicals are those manufactured or imported into the U.S. in quantities exceeding a million pounds per year. Data availability reviews have already begun for most chemicals covered by this initiative. The goal is for companies to make complete hazard data sets publicly available on the majority of 2,800 HPV chemicals by 2004. Total cost of the program is estimated to approach $500 million.

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The ACA Position

ACA welcomes the high level of cooperation between all parties to produce an effective voluntary program that will provide EPA and the public with an unprecedented amount of information on the health and environmental effects of HPV chemicals. The program is a significant improvement over traditional "command-and-control" regulatory approaches. However, the next important step will be to continue the cooperative approach to ensure risk-based decision-making, particularly in developing and communicating use and exposure information. This additional information would put hazard information from the HPV Chemical Challenge program into an appropriate risk communication context.

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The Genesis of the HPV Challenge

A cooperative international program for screening HPV chemicals for potential hazards was established 10 years ago by the Organization for Economic Cooperation and Development (OECD). Countries participating in that program (known as Screening Information Data Sets or SIDS) agreed on an appropriate process for conducting hazard assessments. However, to date only a few hundred of the nearly 4,000 global HPV chemicals have been assessed under this program.

In mid-1997, ED, then the Environmental Defense Fund (EDF) released a report claiming there was a lack of publicly available hazard screening data for a sample list of HPV chemicals. Subsequent studies by EPA and the American Chemistry Council found that complete SIDS data sets were not publicly available for a majority of U.S. HPV chemicals. In April 1998, Vice President Al Gore unveiled a "Chemical Right to Know" initiative that included a challenge to increase HPV chemical hazard data generation. That initiative called on industry to complete SIDS-level assessments on all of the 2,800 U.S. HPV chemicals within three years or face mandatory testing under the Toxic Substances Control Act (TSCA). In discussions between the Council, ED and EPA, the voluntary program evolved into an alternative approach: a voluntary initiative that allowed flexibility where scientifically appropriate.

Subsequently, the program was expanded to incorporate work done by producers in other parts of the world, primarily through the International Council of Chemical Associations (ICCA) and the opening of consortia in one country to participation of companies from another International participation in the initiative is essential: HPV chemicals are manufactured around the world, and the burden of data development should be shared globally.

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The Framework Agreement

For several months after the Vice President's April 1998 challenge, industry met with EPA, ED and others to develop agreement around an alternative voluntary approach to the challenge. The agreement, referred to as the "framework," was announced in October 1998. Among other things, the agreement: 1. Allows six years (until 2004) to complete data hazard data generation.
2. Permits assessment of chemicals by "category" approaches.
3. Establishes an industry developed Internet-based tracking system to enable the public, media, regulators, the scientific community and others to monitor progress of the HPV Challenge.
4. Provides that chemicals not volunteered by companies or consortia will be subject to mandatory testing under TSCA test rules.
5. Stipulates that results be made public.


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The Status of the HPV Challenge

At the deadline for participating in the "voluntary" program, 437 companies and 147 consortia had signed up to assess 2,080 chemicals. EPA, industry and environmental groups are pleased with the program's success.

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Industry Consortia

Most HPV chemicals are made by more than one company. As a part of its effort to encourage chemical companies to participate in the HPV Challenge, ACA member organizations and others are acting as facilitators for companies to form consortia-to provide an efficient, easy way for manufacturers and importers of the same chemicals to share existing information and conduct joint assessments.

Many of the consortia are coordinated through ACA member organizations. Companies are sharing the responsibilities for conducting the data assessments with other manufacturers of the same chemical or class of chemicals, and have access to the wide array of administrative and technical services offered through ACA member organizations.

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The Internet Tracking System

The Internet-based tracking system is a critical part of the initiative. The tracking system allows companies and consortia to record commitments and work plans. It is fully open to the public for viewing and comment.

The Internet address is http://www.hpvchallenge.com.

The system provides a conduit for EPA and others to review test plans, and a window for the public and others, including the media, to watch the progress of the challenge program. Individual companies and consortia that agree to participate in the program identify themselves and the chemicals that they have volunteered. They also publicly commit to a timetable; work plans will be submitted later for public comment. Notices will be posted if progress against these timetables slips beyond 60 days.

The public has access to all of the information put into the tracking system-as well as access to the EPA site on which "robust summaries" of results will be posted.

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