Can You Keep a Secret? The Pros and Cons of the US Environmental Protection Agency’s Strengthening Transparency Rule


In 2018, the US Environmental Protection Agency (US EPA) requested comment on its proposed Strengthening Transparency in Regulatory Science rule, which in its proposed form will direct the US EPA to “use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments.” Advocates and detractors of the rule presented their viewpoints at the SOT 58th Annual Meeting and ToxExpo during an animated SOT Roundtable Session titled “Data for Chemical Evaluations: Secret or Otherwise.”

What isn’t secret is the controversy surrounding the US EPA proposed rule, with over 600,000 comments submitted to the US EPA. Dr. Lynn Goldman of the George Washington University (and former US EPA Assistant Administrator for the US EPA Office of Prevention, Pesticides and Toxic Substances) warned that the rule dictates science processes by rulemaking. Evidence-based medicine in practice uses systematic review and meta-analysis as a way to collect, pool, and analyze data. Such approaches would be hindered by the rule’s requirement for open data access. Data access has a number of benefits, such as promoting reproducibility among studies, but on the con side, free access to data poses privacy concerns to individuals about whom the data are collected.

Dr. Jim Bus of Exponent quoted an SOT position statement from the 1990s—“Judge science for its merits, not the source of its funding”—and advocated for scientific data transparency (regardless of its source) in order to judge the merits of the science. According to Gibson’s Law, for every PhD, there is an equal and opposite PhD. Monday’s Roundtable evidenced that equally learned PhDs have very different opinions on the long-term public health consequences of the US EPA proposed Strengthening Transparency rule.

This blog was prepared by an SOT Reporter. SOT Reporters are SOT members who volunteer to write about sessions and events they attend during the SOT Annual Meeting and ToxExpo. If you are interested in participating in the SOT Reporter program in the future, please email Giuliana Macaluso.

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