Background: Launched by the U.S. Environmental Protection Agency (EPA) in 1998, the High Production Volume (HPV) Challenge Program was developed to address the perceived gap in basic hazard information for the 2,800 chemicals produced or imported into the United States in quantities of ≥ 1 million pounds per year. Health and environmental effects data obtained from either existing information or through new vertebrate animal testing were voluntarily submitted by chemical companies (sponsors) to the U.S. EPA. Despite the potential for extensive animal testing, animal welfare guidelines were not provided until after the start of the program.Objectives: We evaluated compliance with the animal welfare principles that arose from an agreement reached between the U.S. EPA and animal protection organizations and tracked the HPV program’s use of animals for testing.Discussion: Under a worst-case scenario, the HPV program had the potential to consume 3.5 million animals in new testing. After application of animal-saving measures, approximately 127,000 were actually used. Categorization of chemicals based on similar structure–activity and application of read-across, along with use of existing test data, were the most effective means of reducing animal testing. However, animal-saving measures were inconsistently used by both sponsors and the U.S. EPA.Conclusions: Lessons learned from the HPV program can be applied to future programs to minimize animal testing and promote more human-relevant chemical risk assessment.
Under the US Environmental Protection Agency (EPA) High Production Volume (HPV) Challenge Programme, chemical companies have volunteered to conduct screening-level toxicity tests on approximately 2800 widely-used industrial chemicals. Participating companies are committed to providing available toxicity information to the EPA and presenting testing proposals for review by the EPA and posting on the EPA Web site as public information. People for the Ethical Treatment of Animals (PETA) and a coalition of animal protection organisations have reviewed all the test plans submitted by the participating chemical companies for compliance with the original HPV framework, as well as with animal welfare guidelines issued by the EPA in October 1999. Our review found major and recurring flaws in the programme's execution, as well as in its fundamental design. Approximately 75% of the test plans reviewed violated fundamental terms of the programme. Many participating companies failed to conduct comprehensive analyses of available data and instead proposed superfluous and meaningless tests. The US HPV programme's exclusion of human health and exposure data has led to numerous examples of irrelevant experiments that will not affect how a chemical substance is used or handled. Contrary to claims by both the EPA and Environmental Defense that few new animal tests are being performed, an estimated 100,000 animals have already died in this US Government-sponsored animal-testing programme.
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