Whereas European Union law requires that justification for causing pain to animals be established prior to their use in tests and that non-animal tests be used whenever practically available, no similar regulations exist in the United States. The U.S. government is therefore able to push ahead with the endocrine-disruptor screening program — a massive animal-testing plan that will cause immense animal suffering—in the face of serious questions about its justification and the validity and usefulness of the proposed tests. The EPA is unable even to define what an "endocrine disruptor" is or what constitutes an "adverse effect" and has no idea how to interpret the massive amount of questionable data that will be generated.
Because scientists are only beginning to understand the complex issues surrounding endocrine disruptors (as recently as November 1999, Theo Colborn was quoted in the press as saying, "We’re in the very early stages of understanding this"), many have expressed concern that regulatory testing in the near future will fail to accurately pinpoint chemicals that really are of concern. When members of the EPA’s endocrine advisory committee raised this question during a recent meeting, stating that the tests that the EPA plans to require include "only a very limited part of the potential universe of endocrine systems," Dr. Penelope Fenner-Crisp, an EPA senior scientist, could only respond that the decision to limit the number of effects covered by the tests was due to constraints that were "practical, albeit not necessarily scientific." When questioned as to why the EPA is not spending further time and effort on researching and developing a realistic strategy for endocrine disruptors, Dr. Fenner-Crisp referred to the time constraints set in the FQPA that require the EPA to "implement" the testing program by 1999 and she stated, "We have to do something that looks like implementation."
Concerns that the unrealistic timeframe set by the FQPA will result in a woefully inadequate program have also been raised by Dr. John Giesy, an environmental toxicologist and member of the National Academy of Sciences, who told scientists at a separate meeting, held shortly after the FQPA was enacted, "At this time, legislating endocrine testing is unbelievably stupid and a waste of resources that will lead to false positives in screening, but more importantly, to false negatives."
The high level of uncertainty surrounding endocrine disruptors is surely what led the National Research Council to recommend repeatedly throughout its report that an intensive research program consisting of various epidemiological studies on the human population was critically needed. For example, the Council wrote, "Appropriately designed and conducted case-control and retrospective cohort studies are needed to document the presence or absence of associations between [endocrine disruptors] and various cancers in humans. ... Background concentrations of [endocrine disruptors] in humans, particularly in adipose tissue and blood, and other biota need to be established. In particular, routes of exposure and the effect of diet need to be assessed to provide a framework for examining the effects of these compounds in the general population and in highly exposed subpopulations. ... Prospective and cross-sectional studies using cohorts tracked from conception through adulthood are particularly needed on female and male reproductive endpoints."
The sensible alternative recommendations proposed by the NRC and others are being discounted by officials at the EPA. The EPA continues to press ahead with a sweeping regulatory program that relies almost exclusively on crude and cruel animal tests and ignores the major scientific issues that have arisen.
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