CONTINUE READING ON freshlawblog.com
US EPA announced on April 24, 2018 that EPA Administrator, Scott Pruitt, had signed a proposed rule to strengthen the science used in regulations issued by US EPA. The proposed rule, “Strengthening Transparency in Regulatory Science,” was published on April 30, 2018 and would require that – where scientific studies are pivotal to US EPA’s regulatory action – “the data underlying those [studies] are publicly available in a manner sufficient for independent validation.” Administrator Pruitt described the rule as an end to “the era of secret science.” US EPA solicited comments regarding the rule, how it can best be promulgated and implemented, and its effects on existing US EPA programs.
Critics argue that the requirement to use only studies with publicly available data could eliminate research where intellectual property or privacy concerns require withholding such data. In an open letter to US EPA, the editors of five scientific publications noted that many peer reviewed journals support data sharing but recognize the need for different levels of stringency in privacy protections. “[I]n not every case can all data be fully shared. Exceptional circumstances, where data cannot be shared openly with all, include data sets featuring personal identifiers.” Other critics note that the public health studies often relied on by US EPA cannot be replicated for “independent validation” because replication would involve exposing the public to the hazardous or toxic substances being studied. Thus, the proposed rule would unreasonably limit the US EPA’s use of important research.