The High Production Volume Challenge Program
The U.S. Environmental Protection Agency’s (EPA) High Production Volume (HPV) Challenge Program is a prime example of how an alternative approach to the traditional ‘‘command and control’’ rulemaking process can help achieve impressive results and greater efﬁciency of resource utilization by promoting involvement and cooperation among a diverse group of stakeholders to achieve critical public health and environmental objectives. Under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the U.S. EPA is empowered to require the submission of data on the health and environmental effects of chemical substances that are subject to the Act and are either manufactured in or imported into the United States. However, TSCA
SECTION I: INFLUENCE OF THE REGULATORY PROCESS ON TOXICOLOGY
speciﬁes that it is the responsibility of the industry to conduct testing, if needed, to develop this information. Traditionally, data have been developed through a rulemaking process, following procedures that are time consuming and resource intensive for both the Agency and the regulated community. Unfortunately, this process has often been adversarial in nature. By working in parallel with the traditional statutory-speciﬁed process of acquiring this information, the HPV Challenge Program has signiﬁcantly accelerated the collection and public availability of baseline health and environmental effects data on more than 2100 widely used industrial chemicals. It has demonstrated the power of voluntary partnerships among the industry, environmental groups, and the EPA to achieve results in cases where a regulatory approach would likely have been much less effective.