After an announcement last week, the official text of the newly proposed scientific transparency rules was published in the Federal Register today. The rule looks to add Part 30, sections 30.1-30.10, to Title 40 of the Code of Federal Regulations. The docket for this proposed rule is EPA-HQ-OA-2018-0259. This docket may be used for submitting and reading comments to the proposed rule, which are currently due by May 30, 2018, at Regulations.gov.

Despite all of the fanfare associated with this proposal, the actual text is fairly short. The total announcement in the Federal Register only spans 7 pages. However, the effect of this seemingly small rule could be quite widespread as it attempts to change the rules about science used to support EPA regulations and findings. The proposed rule is titled “Strengthening Transparency in Regulatory Science.” According to the proposed section 30.1, the purpose is to “ensure that the regulatory science underlying its [EPA’s] actions is publicly available in a manner sufficient for independent validation.” More specifically, section 30.5 goes on to discuss what might need to be released in order to ensure the possibility of independent validation; this would include data, protocols that are necessary to understand and assess the conclusions of the study, computer codes and models involved in creating and analyzing the data, recorded factual materials, and detailed descriptions of how to access and use the information. The concept of proprietary software or even work product in collection of the data would clearly not be allowed under this rule.

However, it is important to note that this rule does not apply to all scientific research. The rule applies to dose response data and models underlying pivotal regulatory science. Both terms are defined in section 30.2, and the rule seeks comments on both of these definitions. Dose response data and models refers to the “data and models used to characterize the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and the magnitude of a predicted health or environmental impact.” Pivotal regulatory science “means the specific scientific studies or analyses that drive the requirements and/or quantitative analysis of EPA final significant regulatory decisions.” 3 other terms are defined in the rule, although some of these definitions are really found in other documents. For instance, regulatory decisions are “final regulations determined to be ‘significant regulatory actions’ by the Office of Management and Budget pursuant to Executive Order 12866”; and research data “means ‘research data’ as that term is defined in the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.” Finally, regulatory science “means scientific information, including assessments, models, criteria documents, and regulatory impact analyses, that provide the basis for EPA final significant regulatory decisions.”

Section 30.7 discusses the role of peer review in the new rule. The EPA itself is supposed to conduct peer review on all pivotal regulatory science that is used to justify regulatory decisions. The EPA will ask peer reviewers to discuss the strengths and weaknesses of the EPA’s justification for assumptions applied and implications of the assumptions to the results. There is no real discussion about who will be specifically conducting the peer review process. This is one aspect of many where the rule is light on the specifics of implementation. Other aspects lacking clarity include the manner in which the EPA will make the information underlying the science available for the independent public verification. The request for comments includes a request for suggestions on how to implement the rule including the possibility of new platforms to disperse the information. There is also a request for comments on how to ensure privacy needs for some of the underlying data as well as ensuring copyright protection for copyrighted material while still maintaining transparency.  In terms of the cost of implementing the rule, there is only a token statement in section 30.8 that the EPA will implement the provisions in a manner that minimizes costs.

In justifying the action being taken, the EPA points to provisions in  the Clean Air Act; Clean Water Act; Safe Drinking Water Act; Resource Conservation and Recovery Act; Comprehensive Environmental Response, Compensation, and Liability Act; Emergency Planning and Community Right-To-Know-Act; Federal Insecticide, Fungicide, and Rodenticide Act; and Toxic Substances Control Act. The Rule also points to Executive Order 13563, which stated that the EPA’s regulatory actions should be founded on the best available science. Executive Orders 13777 and 13787 are also cited for the idea that transparency in underlying data and the regulatory process is needed. The proposal also notes that there were third party organizations who lobbied for open science and then names The Administrative Conference of the United States’ Science in the Administrative Process Project, National Academies’ reports, Health Effects Institute, Center for Open Science, members of the Risk Assessment Specialty Section of the Society of Toxicology, the Does Response Section of the Society for Risk Analysis, the International Society for Regulatory Toxicology and Pharmacology, and the Bipartisan Center’s Science for Policy Project.  Finally, the “replication crisis” is cited as a reason for taking this action. For this last point there are citations to various articles including A Manifesto for reproducible science in Nature Human Behaviour; Why most published research findings are false in PLOS Medicine; Reproducibility from Science; How Science goes wrong from the Economist; and What does research reproducibility mean in Science.

The proposed rules have drawn some criticism from those in the scientific community. Although the benefit of transparency is not being denied, some are concerned that privacy and non-disclosure agreements that help recruit study participants will make it hard to comply with these new requirements and thus provide justification for the EPA to ignore good science and thus put the health and welfare of Americans at risk. Some see this as a way for the current EPA Administrator to attack science he does not believe in, but cloak it in an argument that he is fighting for greater transparency in the environmental process. It will be interesting to see how the EPA responds to some of the comments it is sure to receive relating to this issue.