EPA has announced an extension of the comment period and a public hearing on its proposed rule titled “Strengthening Transparency in Regulatory Science,” published in the Federal Register on April 30, 2018. The public comment period, originally scheduled to close on May 30, 2018, will now end on August 16, 2018. Comments may be submitted at www.regulations.gov identified by docket number EPA-HQ-OA-2018-0259. The public hearing will be held on July 17, 2018 at EPA’s William Jefferson Clinton East Building, Main Floor Room 1153, 1201 Constitution Avenue, N.W., Washington, D.C., from 8:00 a.m. to 8:00 p.m. (EST). Individuals wishing to present oral testimony must register by July 15th via email at firstname.lastname@example.org or online by clicking here.
EPA states that its proposed rule is intended to establish a clear policy for the transparency of the scientific information used for significant regulations (those having an economic impact of $100 million or more) and to ensure that the data supporting its regulatory actions can be independently verified. More specifically, the Agency states that its proposal is designed to “increase access to dose response data and models underlying ‘pivotal regulatory science’ in a manner consistent with statutory requirements for the protection of privacy and confidentiality of research participants, protection of proprietary data and confidential business information, and other compelling interests.” The draft rule sets forth a definition of ‘pivotal regulatory science’ as “the studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point-of-departure from which a reference value is calculated.”
The draft rule would require EPA to conduct independent peer review on all ‘pivotal regulatory science’ used to justify regulatory decisions. In addition, the proposal would allow the EPA Administrator to grant exemptions to its data transparency requirements on a case-by-case basis. EPA cites a number of environmental statutes as providing the underlying authority for its proposed rulemaking including the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
The Agency is seeking comment on a number of far-reaching issues such as the potential effects of the proposed rule on individual EPA programs, how to balance appropriate protection of confidential business information with the proposed requirements for increased transparency of pivotal regulatory science, and whether the transparency requirements should apply to other types of regulatory actions such as guidance. EPA provides an expansive list of other issues for which it is inviting public comment on the draft rule.
Since its publication, the draft rule has generated a significant level of controversy from critics who voice concerns that its proposed requirements would limit the available scientific information and studies upon which EPA bases its regulatory decisions. They also charge that EPA truncated the required Office of Management and Budget (OMB) review process in a rush to get the proposed rule published in the Federal Register.
It is not clear to what extent the proposed rule, as written, would have on EPA pesticide registration and tolerance review activities. While EPA states that “nothing in the proposed rule compels the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections,” there is concern within the pesticide registrant community that CBI protections could be weakened or compromised under this initiative. A copy of the draft rule may be accessed by clicking here.