Regulation and Policy Update: US EPA Strengthening Transparency Rule and Human Fetal Tissue Research Policy


By George Daston posted 01-14-2021 16:44


US EPA Strengthening Transparency Rule Went into Effect on January 6

Last week, the US Environmental Protection Agency (US EPA) released a final rule titled “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.”

When this rule was in draft stages, SOT expressed concern about the language in use and the types of data and research that this rule would exclude from consideration in public health policy-making. Our reservations regarding this rule were first expressed in a letter sent to Chair and Ranking Member of the US House of Representatives Committee on Science, Space, and Technology in November 2019. Then, in April 2020, SOT submitted comments on the rule’s draft language, urging the US EPA to consider withdrawing the rule entirely.

SOT leadership is disappointed in the final language of the rule, which still includes problematic aspects to which SOT objected last year. The SOT leadership will monitor how this new guidance is used or addressed by the incoming administration to determine if additional comments or actions are warranted.

Update on NIH Human Fetal Tissue Research Ethics Advisory Board Recommendations

SOT was a signatory on two letters last year—one on July 28, 2020, to the NIH Human Fetal Tissue Research Ethics Advisory Board and another on August 31, 2020, to the US Department of Health and Human Services (US HHS) Secretary—expressing concern about the recommendations of Advisory Board to block all but one research proposal seeking to use human fetal tissue and the HHS policy restricting federal funding for biomedical research involving fetal tissue.

Last week, SOT added its signature to a letter addressed to US President-Elect Joe Biden asking him “to swiftly rescind the human fetal tissue (HFT) research restrictions and policy changes that the Department of Health and Human Services made in 2019.” In addition, the letter encourages the Biden administration “to commission an expert report on the scientific and medical value of HFT research.”