As federal health agencies pour all available resources into halting the spread of the coronavirus disease (COVID-19), the EPA has stepped forward with a second proposal governing the Agency’s use of science at the Agency. The action supplements the EPA’s April 2018 proposal, Strengthening Transparency in Regulatory Science. That proposal would ensure that when developing regulations, the EPA would rely on only data that are publicly available in a manner sufficient for independent validation.
The supplemental proposal modifies the earlier proposal in seven ways. But the most significant proposed change would allow the Agency to give “greater consideration to studies where the underlying data and models are available in a manner sufficient for independent validation.” [emphasis added]
Protection Against Arbitrary Decisions
The EPA’s stated intent in the 2018 action was to increase and strengthen the transparency of Agency rulemaking.
“Enhancing the transparency and validity of the scientific information relied upon by EPA strengthens the integrity of EPA’s regulatory actions and its obligation to ensure the Agency is not arbitrary in its conclusions,” the EPA stated. “By better informing the public, the Agency is enhancing the public’s ability to understand and meaningfully participate in the regulatory process.”
The EPA intended to apply the proposed approach to only dose-response data and dose-response models. (A dose-response relationship describes how the likelihood and severity of adverse health effects, or the responses, are related to the amount and condition of exposure to an agent, or the dose provided). The supplemental proposal would also extend the reach of the transparency provision to additional data and models.
The EPA describes the seven parts of its supplemental proposal as follows:
- The proposed requirements would apply broadly to data and models underlying pivotal regulatory science and pivotal science that support significant regulatory decisions and influential scientific information, respectively, rather than simply to dose-response data and models.
- The proposed provisions would apply to influential scientific information, as well as significant regulatory actions.
- To provide clarity, the Agency is proposing definitions for influential scientific information, pivotal science, capable of being substantially reproduced, data, independent validation, publicly available, and reanalyze.
- The definition of research data proposed in 2018 would be eliminated. That definition is used in other federal programs. Had the EPA retained the definition, the transparency proposal would need to be made consistent with it.
- When promulgating significant regulatory decisions or finalizing influential scientific information, other things being equal, the Agency would give greater consideration to studies in which the underlying data and models are available in a manner sufficient for independent validation either because they are publicly available or because they are available through tiered access when the data include confidential business information, proprietary data, or personally identifiable information that cannot be sufficiently de-identified to protect the data subjects. The Agency would identify those studies that are given greater consideration and would provide a short description of why greater consideration was given.
- The proposal describes the factors the EPA would consider in determining whether to grant an exemption to the proposed public availability requirements for using data and models in significant regulatory decisions and influential scientific information.
- The EPA is proposing the option of using its housekeeping authority either independently as the authority for taking this action or in conjunction with the environmental statutory provisions cited as authority in the 2018 proposed rule. The Federal Housekeeping Statute gives Executive Branch agencies the authority “to govern internal department affairs.” While the EPA was not specifically listed as a department under the statute, the Agency obtained that authority under the Reorganization Plan No. 3 of 1970.
Regarding the housekeeping aspects of the proposal, the EPA emphasizes that the rule would not regulate the conduct or determine the rights of any entity outside the federal government. “Rather, it exclusively pertains to the internal practices of the EPA,” states the Agency.