On March 8, 2017, Representative Lamar Smith (R-TX) proposed an act that could significantly affect the consideration of science by the U.S. Environmental Protection Agency (EPA). The act is H.R. 1430, also known as the Honest Act. Although the scientific community has long advocated sound and effective approaches to the consideration of science by policy makers, it has also raised concerns about this particular approach of limiting EPA’s regulatory actions to only considering research for which the underlying data is publicly available. This article provides a brief explanation of the Honest Act and similar EPA actions, concerns raised by the scientific community, and some surmises about the future of science at EPA.
The Honest Act
The Honest Act would require EPA—when it issues any “risk, exposure, or hazard assessment, criteria document, standard, limitation, regulation, regulatory impact analysis, or guidance”—to rely upon “(A) the best available science; (B) specifically identified; and (C) publicly available online in a manner that is sufficient for independent analysis and substantial reproduction of research results, except that any personally identifiable information, trade secrets, or commercial or financial information obtained from a person and privileged or confidential, shall be redacted prior to public availability.”
The act itself does not specify how these requirements are to be implemented, but simply restricts the agency from justifying any listed actions using data that fails to fulfill the described standards. Thus, a number of questions remain regarding the actual effect of the Act, should the Act be passed: Will EPA create internal procedural rules to restrict its reliance on such data, and, if so, how will those rules be structured? Will EPA, as a grant-giving agency, change its funding of policy-relevant studies to respond to these efforts—for example, by creating procedures for ensured redactability of personal information? And how will these concerns intersect with the human subjects’ research requirements discussed below?
The proposed EPA Data Transparency Rule
The Honest Act is not the only proposed restructuring of the EPA’s use of data in its activities. On April 24, 2018, EPA submitted a proposed rule on data transparency, Strengthening Transparency in Regulatory Science(Transparency Proposal), containing many provisions similar to the Honest Act. The coverage of the Transparency Proposal would pertain to “dose response data and models underlying pivotal regulatory science that are used to justify significant regulatory decisions regardless of the source of funding or identity of the party conducting the regulatory science,” a category that arguably overlaps with, but does not replicate that of, the covered actions under the Honest Act. Moreover, the Transparency Proposal would exempt:
significant regulatory decisions on a case-by-case basis if [the EPA] determines that compliance is impracticable because it is not feasible to ensure that all dose response data and models underlying pivotal regulatory science are publicly available in a fashion that is consistent with law, protects privacy and confidentiality, and is sensitive to national and homeland security
and may therefore allow for more tailoring than the Honest Act.
Critiques of the Honest Act and proposed rule
The changes may hinder EPA’s ability to protect human health
Several critiques have been raised against these proposals. The first is that the requirement that foundational data for listed EPA actions be publicly available could drastically limit the numbers of public health studies that EPA could use, thus weakening the agency’s ability to engage in health-protective actions. Many studies used by EPA to assess the health impacts of pollutants have guaranteed confidentiality to their participants, due to privacy concerns related to releasing an individual’s health status. The structures of these studies’ data collection often make after-the-fact redaction impossible.
For example, one of the major peer-reviewed studies of air pollution and public health, known as the “Six Cities” study—foundational for much of current air pollution regulation by establishing connections between air pollution and premature deaths—focused on how air pollution affected the health of around 22 thousand individuals for two decades. Under the proposed act/rule, EPA could not rely upon this study without significant data revision for future actions because the researchers had signed confidentiality agreements to track these individuals.
Implementation of these changes may interfere with other regulatory requirements for human subjects’ research
Guarantees of confidentiality are not granted only to protect individuals’ requests for privacy; they are often required by funding agencies. Most federal agencies require their grantees to follow what is known as the Common Rule,developed in response to ethical lapses associated with the Tuskegee Experiment that were brought to light in the 1970s. Among other things, the Common Rule requires researchers to follow basic provisions of informed consent, including that “[w]hen appropriate, [human subjects research must contain] adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.” 45 C.F.R. § 46.111(a)(7).
These changes may be inconsistent with Administrative Procedure Act requirements
Finally, legal academics have raised concerns that the Honest Act and Transparency Proposal may interfere with the EPA’s ability to fully comply with the arbitrary and capricious judicial review standards of the Administrative Procedure Act (APA). Under the APA, 5 U.S.C. § 706(2)(A), agency actions can be overturned by courts if they are “arbitrary [or] capricious.” Failure to consider published peer-reviewed studies, even if they do not follow the requirements of the Honest Act or the Transparency Proposal, could be regarded as “arbitrary and capricious” by courts, given the APA’s silence on any transparency requirements.
The future of science at EPA
At the time that this article was written, neither the Honest Act nor the Transparency Proposal has been passed. The act was passed by the House on March 29, 2017, but is still pending before the Senate. EPA has extended the notice-and-comment period for the Transparency Proposal until August 16, 2018. Moreover, questions about the implementation of these proposals (for example, if the Honest Act is passed or if the Transparency Proposal survives legal challenge) remain. Nevertheless, both the act and the proposal signal the importance of paying attention to the ways in which science is considered before EPA, in addition to its substantive decisions.