ACA Comments on EPA Proposed Rule: Strengthening Transparency in Regulatory Science
September 12, 2018
Last month, ACA submitted comments to the U.S. Environmental Protection Agency (EPA), on a proposed rule, “Strengthening Transparency in Regulatory Science.” EPA’s proposal requires the agency make dose response data and models from studies underlying its actions publicly available in a manner sufficient for independent validation, when issuing a significant regulatory action, as specified in E.O. 12866, “Improving Regulation and Regulatory Review.” EPA would also be required to describe variability and evaluate default assumptions contained in scientific studies it uses in a significant regulatory action. EPA would further be required to conduct independent peer review on all pivotal regulatory science used to justify significant regulatory actions.
Notably, the proposal authorizes EPA to grant exemptions on a case-by-case basis where it is not feasible to make dose response data and models publicly available or peer review is not feasible, in a manner that would protect confidentiality, trade secrets, national security or otherwise in compliance with the law.
ACA generally supports this proposal and encourages EPA to disclose pivotal regulatory science – the science used to support a significant regulatory action – but offered some suggestion for further clarification and practical enhancement, including the following:
- Broadening factors EPA considers in evaluating pivotal regulatory science beyond consideration of dose response data and models with comment from peer review; and
- Providing more clarity about how EPA would use studies where dose response data and models are not available, assuming the proposal would not bar such studies from EPA’s consideration.
In its comments, ACA underscored that it is not recommending that EPA use all studies regardless of quality. However, EPA’s proposal suggests that the quality of a study can be evaluated only by review of dose response data and models with peer review comment, although underlying data of important studies are commonly not available. ACA further maintains that these are not the sole criteria used among scientists, when evaluating a study. Other criteria include evaluation of mechanisms, scientific methods and related logical inferences, consideration of converging evidence of conclusions from multiple sources and replicability of a study and its conclusions based on provided information and similar published studies.
In effect, ACA believes EPA’s proposal could be interpreted in a manner that is overly restrictive. EPA might also interpret this proposal in a manner that screens science studies using narrower criteria than Congress indicated for risk evaluations under the Toxic Substances Control Act (TSCA), where EPA is required to use the “best available science.” The concept of “best available science” also applies to EPA decision-making generally and in other statutory programs, as explained in E.O. 13563.
To that end, ACA asked EPA to consider amending the text of proposed 40 CFR §30.5 to provide for disclosure of dose response data and models “when available. ACA also suggested the following:
- EPA amend proposed 40 CFR §30.4 (requiring EPA make studies available to the public) by noting that this rule shall not be used to exclude a study from EPA’s review and consideration of conclusions drawn therein, where EPA determines the study is compatible with the “best available science;”
- EPA amend proposed 40 CFR §30.6 to require EPA make available analysis of how it weighs and/or evaluates the conclusions drawn in a study based on criteria of “best available science;”
- EPA amend 40 CFR §§ 30.4 (identification of studies), 30.5 (disclosure of data and models), 30.6 (documentation and evaluation of studies) and 30.7 (peer review) to require these steps at an interim phase prior to issuance of the final rule;
- EPA amend 40 CFR §30.9 regarding exemptions, to include an exemption from publication of dose response and methods, when not available, for studies EPA concludes are the “best available science,” using factors EPA has articulated for “best available science;”
- EPA determine a standard to either sanitizing certain aspects of the data, so that it can be made publicly available, or a procedure regarding selective publication so that certain aspects of these studies can also be made publicly available;
- EPA develop more specific focused criteria for significant regulatory actions, considering the range of EPA regulatory and policy activities that the Agency conducts. One possible way to meet this suggestion is by having each Program Office establish a list of rulemaking categories that would not be deemed significant, and thus minimizing any potential confusion; and
- EPA establish guidance or more fleshed-out regulatory language that clarifies the extent to which the exemptions can be used, and a more direct pathway to streamline the process while providing consistent criteria for exemptions.
ACA contends that these changes would allow EPA to continue considering data from the European Union and Canada during TSCA risk evaluations and promote industry participation in TSCA risk evaluations, as well.
Contact ACA’s Riaz Zaman for more information.