A goal of toxicological innovation is to produce safer and more effective products. In highly controlled first-world consumer and industrial markets, this means incorporating new discoveries into regulation.  Some criticize the slow pace of updating regulations, but fail to recognize that useful regulation must fit a purpose, not merely promote a new technology or area of investigation.  A case study of the Endocrine Disruptor Screening Program (EDSP) illustrates several principles regarding how to, and how not to, incorporate scientific discovery into effective regulation and risk assessment.  1) During inception, needs should be clearly demonstrated by measurable benefits and liabilities: in the case purported for endocrine disruption, human health problems were inferred from the decades-old clinical tragedy of diethylstilbestrol, while environmental effects were incorrectly assumed from fish downstream of highly contaminated sewage treatment plants in the UK. 2) Unintended implications should be carefully considered before implementation: the EDSP refocused chemical safety assessment from effects to possible modes of action, which complicates development of screening strategies and hampers clear regulation to the present as is evident from current debates over labeling criteria in the European Union. 3) Validation is costly, but essential: numerous examples of toxicological innovation failures associated with the EDSP could have been avoided with appropriate study designs and communication of potential limitations (e.g. the highly-touted in ovo reptilian assays failed because fundamentals of method development were ignored in foundational studies; the minced testis assay procedure was not broadly transferable, and; the pubertal assay required new definitions of the maximum tolerated dose to be validated).  Finally, EDSP implementation revealed the need for further adjustments even for some validated assays, and fifteen years later the results have revealed little new information.  While this is reassuring  for chemical safety, it is disturbing for cost-benefit of the program and has negative repercussions associated with the public’s trust in science. <br/>

Promise and peril; fact versus fiction: Forethought, verification and validation in translating discoveries into regulation and risk assessment

254th National Meeting (2017)

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