Toxicology: judge data or dollars?

activity of DDT analogs and polychlorinated biphenyls. levels of organochlorine residues and risk of breast cancer. Environmental hormone disruptors: evidence that vinclozolin developmental toxicity is mediated by antian-drogenic metabolites. Dietary estrogens act through estrogen receptor-mediated processes and show no antiestrogenicity in cultured breast cancer cells. The knowledge gained by our work as toxicologic scientists ranges from molecular mechanisms to clinical signs of toxicity, from physiologically based pharmacokinetics to tumor counts. Any of this research, from any source, may be translated into regulatory action in order to protect the public and the environment; thus, society is best served by the best science from every source. The challenge is to find the criteria to accurately and, increasingly, quickly judge which studies are valid and appropriate to affect regulation. Cynics make these quick judgments based on funding sources; traditionalists trust the proven, but slow, peer-review process; regulatory agencies want to see raw data from industry, but have implicitly trusted and exempted academia from this scrutiny. Needs for confidentiality place limits on disclosure, but they do not preclude a more even and open approach to data from all sources. Greater disclosure will result in a scientific process that is faster, better, and more trustworthy -"trust" is the key word here. But, as a former U.S. president said near the end of the Cold War, "Trust but verify." Verification was the apparent goal of a few lines buried deep in the voluminous 1999 Omnibus Spending Bill (1). It states That the Director of OMB amends section-.36 of OMB Circular A-1 0 to require Federal awarding agencies to ensure that all data produced under an award will be made available to the public through the procedures established under the Freedom of Information Act. This new law has provoked, according to one editorial, "...howls of protest from scientists, their institutions, and the federal agencies that fund scientific research" (2). However, major scientific societies, including the American Chemical Society, the Council for Chemical Research, and the American Association for the Advancement of Science, all support, in principle, the need to assess the validity of such research results (3). Recently, it has again been made clear that the issues of quality and reliability of toxicology data and its reasoned interpretation for regulatory purposes are critical (4); the question is how best to accomplish that end.