ASDWA Submits Comments on EPA’s Transparency in Regulatory Science Supplemental Notice

On March 18, 2020, EPA published a supplemental notice of proposed rulemaking to the Strengthening Transparency in Regulatory Science Proposed Rulemaking originally published on April 30, 2018. This supplemental notice proposes:

• the scope of the rulemaking apply to influential scientific information as well as significant regulatory decisions;
• definitions and clarifies that the proposed rulemaking applies to data and models underlying both pivotal science and pivotal regulatory science;
• a modified approach to the public availability provisions for data and models that would underly significant regulatory decisions and an alternate approach.

Today, ASDWA submitted comments on these proposals. ASDWA’s comments support EPA’s ability to consider the best available science in making decisions about public health and environmental protection, even if the underlying data or models are not publicly available and does not agree with the need to limit EPA’s use of scientific studies, even in cases where such studies rely on confidential patient information or when there are other barriers to disclosure, be they legal, ethical, or other. The comments also include the following recommendations:

• Due to the complexity and impracticality of including influential scientific information, ASDWA recommends the final rule only apply to underlying studies, data, and models when promulgating significant regulatory actions;
• Exemptions to this rule are necessary and should be included in the final rule, as it provides flexibility in rule implementation;
• This rule should not apply to the previous record and should clearly state so in the rule. ASDWA supports “grandfathering” completed work, models, and data that have already been used by the agency and supports implementing this rule in stages to prevent further delay of EPA’s work; and
• ASDWA supports EPA’s proposal that when promulgating significant regulatory decisions or finalizing influential scientific information, the Agency will give greater consideration to studies where the underlying data and models are available in a manner sufficient for independent validation, but will still use and consider studies when there is limited or no access to the underlying data and models.