An Evaluation of the US High Production Volume (HPV) Chemical-testing Programme: A Study in (Ir)Relevance, Redundancy and Retro Thinking

Abstract

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.

They See a Rat, We Seek a Cure for Diseases: The Current Status of Animal Experimentation in Medical Practice

“…To summarize, all are agreed that there is a need to reduce rather than eliminate animal experimentation. At the same time, efforts must continue to find suitable replacements for animal experimentation as well as more refined techniques that avoid the use of intact live animals [ 37 , 58 , 59 , 60 , 61 , 62 , 63 ].…”

Animal Use and Lessons Learned in the U.S. High Production Volume Chemicals Challenge Program

“…An early review of the HPV program by the Physicians Committee for Responsible Medicine (Cardello 2001) documented serious flaws in test plans submitted by sponsors, including a ) failure to report existing hazard information and to group structurally or toxicologically similar chemicals; b ) proposed animal tests that were beyond the scope of the HPV program; and c ) lack of enforcement by the U.S. EPA of agreed-upon animal welfare principles. A subsequent evaluation of the HPV program by Nicholson et al (2004) showed that many of the same problems reported by Cardello (2001) still existed. In addition, they found that testing was proposed for chemicals with known toxicities and for irrelevant end points when the primary hazard was high and well known, and that testing in vivo was proposed when valid in vitro methods were available.…”

“…However, some sponsors still proposed animal tests, even when a chemical’s properties rendered the results of these tests meaningless. In the API’s initial test plan for the Petroleum Gases Category, its Petroleum HPV Testing Group (PHTG) proposed separate acute mammalian, repeated dose, reproductive, and developmental toxicity tests on each of the individual gases ethane, butane, propane, and isobutane, even though these gases are explosive at concentrations below those at which health effects are observed and have been shown to act primarily as simple asphyxiants (Nicholson et al 2004). After receiving comments from APOs and the U.S. EPA, the PHTG reconsidered its testing proposal and eliminated from its revised test plan all acute mammalian tests and all separate reproductive and developmental toxicity tests on individual gases (Twerdok 2001).…”

Analytical aspects of meet-in-metabolite analysis for molecular pathway reconstitution from exposure to adverse outcome

“…(Nikfar et al, 2014) chemicals can be considered pseudo-persistent chemicals because of their continuous emission to the environment, even if their half-lives are short (Bergman et al, 2012;Daughton, 2003). These chemicals plus POPs can be a great source of concern if vulnerable subpopulations are exposed to amounts that result in adverse effects (Nicholson et al, 2004). The National Health and Nutrition Examination Survey, a wellknown targeted biomonitoring study, includes a few hundred preselected chemicals for the survey.…”