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EPA Delays Proposal Prohibiting Use of Studies that Withhold Data

The Environmental Protection Agency (EPA) has postponed the finalization of a proposal  that would preclude the agency from relying on scientific studies that do not publicize the data upon which the research is grounded. This rule, if finalized, could be problematic for the development of future regulations since research initiatives often include trade secrets, sensitive business information, and even personal health information, all of which are intended to be kept confidential while being used to enhance policymaking goals. Several prominent studies have relied on the use of confidential information, such as a study conducted by Harvard University in 1993 that studied the link between air pollution and death. The EPA’s “strengthening transparency in regulatory scheme” proposal would mean that scientific studies could not depend on similar confidential information in making its conclusions. Rather, the science that lays the groundwork for the EPA’s regulations would have to be publicly available and independently certifiable.  

This proposal prompted an impassioned reaction during the public comment period. Many of the nearly quarter million responses were critical of the proposal. Various organizations and groups that objected to the proposal maintained that it would limit the data available to researchers in developing environmental regulations. Critics fear that the passage of this rule will allow the EPA to reject certain studies that may be important or useful. The EPA’s Science Advisory Board joined in the opposition to the proposal because of the lack of engagement with the scientific community when drafting the rule.

A significant criticism of the proposed rule is that it directly conflicts with the provisions of the Toxic Substances Control Act (TSCA). TSCA calls for the EPA to incorporate the best available scientific research available when assessing the evidence. Several organizations, including the Environmental Defense Fund, insist that the proposed rule conflicts with the EPA’s responsibilities under TSCA.

On the other side, proponents of the proposed rule have argued that good science – and good public policy – require regulatory decisions to be premised on independently verifiable studies. Use of confidential studies, they claim, undermines confidence in the regulatory process and thwarts good policy.

Officially, the EPA categorized the proposal as part of a “long term” action plan and announced 2020 as the target date for a final determination on its transparency rule. Nevertheless, the agency maintains that it has the authority to move forward to finalize the rule within a quicker timeframe if it sees fit to do so.

Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis on your Prop 65 compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].

Ms. Grimaldi maintains a diverse environmental law practice focusing on chemical and product regulation and litigation defense. Her practice areas include Proposition 65, California's Safer Consumer Products Regulations, California's Rigid Plastic Packaging Container Act and the federal Toxic Substances Control Act. Ms. Grimaldi graduated from the University of California Hastings College of the Law magna cum laude and holds a Bachelor of Science Degree in Bacteriology from University of California, Davis. Prior to attending law school, she worked as a research assistant in laboratories at the University of California, San Francisco Cancer Research Institute and at the University of California, San Francisco School of Medicine.