On March 3, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule. EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.” The SNPRM:

• Proposes that the scope of the rulemaking applies to influential scientific information, as well as significant regulatory decisions;

• Defines and clarifies that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science;

• Proposes a modified approach to the availability provisions for data and models that would underlie influential scientific information and significant regulatory decisions, as well as an alternate approach; and

• Clarifies the ability of the Administrator to grant exemptions.

EPA posted a pre-publication version of the SNPRM. Publication of the SNPRM in the Federal Register will begin a 30-day comment period. EPA states that it “is taking comment on whether to use its housekeeping authority independently or in conjunction with appropriate environmental statutory provisions as authority for taking this action.” EPA states that it anticipates promulgating a final rule later in 2020.

Background

On April 30, 2018, EPA issued the "Strengthening Transparency in Regulatory Science" proposed rule (Science Rule) that EPA states is intended to “strengthen the transparency of EPA regulatory science.” 83 Fed. Reg. 18768. EPA states in the preamble that “[t]he proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific studies that are pivotal to the action being taken, EPA should ensure that the data underlying those are publicly available in a manner sufficient for independent validation.” EPA further states that “EPA is proposing to establish a clear policy for the transparency of the scientific information used for significant regulations: specifically, the dose response data and models that underlie what we are calling ‘pivotal regulatory science.’ ‘Pivotal regulatory science’ is the studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point-of-departure from which a reference value is calculated.”

EPA intends the rule to provide this transparency “in a manner consistent with statutory requirements for protection of privacy and confidentiality of research participants, protection of proprietary data and confidential business information, and other compelling interests.” EPA “will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments.” EPA states that its “regulatory science” should be “consistent with the Office Management and Budget’s Final Information Quality Bulletin for Peer Review,” and that “[r]obust peer review plays a critical role in independently validating key findings and ensuring that the quality of published information meets the standards of the scientific and technical community.” In addition, EPA states, the proposed rule “is designed to increase transparency of the assumptions underlying dose response models,” noting that “[t]he use of default models, without consideration of alternatives or model uncertainty, can obscure the scientific justification for EPA actions.” More information on the proposed rule is available in our April 30, 2018, memorandum, “EPA Releases Strengthening Transparency in Regulatory Science Proposed Rule.”

SNPRM

EPA states that it is issuing the SNPRM to clarify, modify, and supplement certain provisions included in the 2018 proposed rulemaking in response to some of the public comments, as well as to ensure consistency with the April 2019 Office of Management and Budget (OMB) Memorandum to the Heads of Executive Departments and Agencies entitled Improving Implementation of the Information Quality Act (OMB M-19-15). According to EPA, the memorandum is directly relevant to several provisions of the 2018 proposed rule “because it updates implementation of OMB’s 2002 Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies to, among other things, reflect recent innovations and policies surrounding information access.”

First, EPA states, it is modifying the regulatory text proposed in the 2018 proposed rule at 40 C.F.R. Sections 30.3, 30.5, 30.6, and 30.9 so that these provisions would apply to data and models, not only dose-response data and dose-response models. In addition, the SNPRM clarifies that the use of the terms “model assumptions” and “models” in the proposed regulatory text at 40 C.F.R. Section 30.6 apply to the assumptions that drive the model’s analytic results. According to the SNPRM, EPA has modified the regulatory text at 40 C.F.R. Section 30.6 to reflect this clarification. EPA notes that this approach is consistent with OMB M-19-15, which highlights the need to characterize the sensitivity of an agency’s conclusions to analytic assumptions.

Second, the SNPRM proposes to expand the scope of the rulemaking to apply to influential scientific information, as well as significant regulatory actions. EPA proposes to add definitions for “influential scientific information” and “pivotal science” at 40 C.F.R. Section 30.2 that will pertain to the science underlying influential scientific information, which are not regulatory, and to make conforming changes to proposed 40 C.F.R. Sections 30.3, 30.5, 30.6, and 30.7. EPA states that it is retaining the definition of “pivotal regulatory science” from the 2018 proposed rule regulatory text.

Third, the SNPRM modifies, deletes, and proposes new regulatory text, in addition to proposing definitions for “influential scientific information” and “pivotal science” at proposed 40 C.F.R. Section 30.2. The SNPRM deletes the first paragraph of the 2018 proposed regulatory text at 40 C.F.R. Section 30.2 and the definition of “research data” at 40 C.F.R. Section 30.2. The SNPRM proposes definitions for the terms “capable of being substantially reproduced,” “data,” “independent validation,” “model,” “publicly available,” and “reanalyze.” According to EPA, these revisions are intended to provide clarity on key terminology used in the regulatory text in the 2018 proposed rule, as well as in the SNPRM.

Fourth, the SNPRM deletes the 2018 proposed regulatory text at 40 C.F.R. Section 30.10. EPA states that this change is being made to be consistent with the deletion of “research data” in 40 C.F.R. Section 30.2 because 40 C.F.R. Section 30.10 would have required EPA to implement the rulemaking to be consistent with the definition of “research data.” With the deletion of “research data” from proposed 40 C.F.R. Section 30.2, proposed 40 C.F.R. Section 30.10 is no longer needed.

Fifth, the SNPRM is proposing a modified version of the regulatory text at 40 C.F.R. Section 30.5 from that proposed in the 2018 proposed rule. According to EPA, under this new approach to proposed 40 C.F.R. Section 30.5, when promulgating significant regulatory decisions or issuing final influential scientific information, it “will only use pivotal regulatory science and/or pivotal science if the data and models are available in a manner sufficient for independent validation.” EPA states that this includes studies with data and models that are publicly available, as well as studies with restricted data and models (i.e., those that include confidential business information (CBI), proprietary data, or Personally Identifiable Information (PII) that cannot be sufficiently de-identified to protect the data subjects) if there is tiered access to these data and models in a manner sufficient for independent validation. Tiered access includes the appropriate techniques used to reduce the risk of re-identification and, therefore, mitigate certain disclosure privacy risks associated with providing such access.

EPA states that as an alternative, it is proposing that under proposed 40 C.F.R. Section 30.5, when promulgating significant regulatory decisions or issuing final influential scientific information, “other things being equal, the Agency will give greater consideration to studies where 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 includes CBI, proprietary data, or PII that cannot be sufficiently de-identified to protect the data subjects.” EPA will identify those studies that are given greater consideration and will provide a short description of why greater consideration was given. EPA notes that as discussed later in the preamble, such approaches to increasing access to data and models can often allow stakeholders to reanalyze the data and models and explore the sensitivity of the conclusions to alternative assumptions while accessing only the data and aspects of the models that they need. The proposed SNPRM would apply to reviews of data, models, and studies at the time a rule is developed or influential scientific information is prepared in final, regardless of when the data and models were generated.

Sixth, the SNPRM would modify 40 C.F.R. Section 30.9 to describe the factors the Administrator 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.

Seventh, EPA proposes the option of using its housekeeping authority independently as authority for taking this action or in conjunction with the environmental statutory provisions cited as authority in the 2018 proposed rule (as clarified in the SNPRM). EPA states that it continues to consider whether it is appropriate to rely on its authority in the above-referenced environmental statutory provisions (potentially in conjunction with its housekeeping authority). According to the SNPRM, EPA will consider comments on this issue submitted in response to the 2018 proposed rule and in response to the SNPRM. Section 301 authority as transferred to EPA in Reorganization Plan No. 3 of 1970 provides appropriate authority for EPA to promulgate regulations that govern internal agency procedures. This action establishes internal agency procedures governing how EPA employees will handle studies when the data and models underlying science that is pivotal to EPA’s significant regulatory decisions and/or influential scientific information are or are not publicly available.

EPA notes that the 2018 proposed rule solicited comment on all aspects of the proposed rulemaking. The SNPRM solicits comment only on the changes and additions to the proposed regulatory text discussed above. EPA states that comments submitted in response to the SNPRM that address aspects of the 2018 proposed rule that are not addressed, altered, or replaced by the SNPRM “will be deemed outside the scope of this supplemental action.”

Commentary

EPA’s original proposal was the subject of significant controversy, including many public comments of concern and an EPA Science Advisory Board (SAB) report raising issues. The SNPRM is intended to address these issues, but the proposed expansions of, and changes to, the original proposal are likely to create new issues and concerns.

The expansion of the scope of the rule, to cover all EPA “influential science,” while welcome to some who believe that the science underpinning significant EPA decisions has not been available for appropriate scrutiny, has already drawn significant criticism from others. Many critics believe that EPA lacked a legal basis for promulgating the original proposal, that the proposal leaves too much to EPA’s discretion as to what data are subject to it, and that it will hamper, not help sound EPA decision-making. Likewise, concerns have been expressed about EPA’s potential inability to consider certain studies under the rule, with epidemiological data often referenced as an example. Additionally, some have expressed concern that the 30-day comment period is too brief for a rule that will have significant consequences.

It will be important to monitor the comment process and resolution of the many issues raised by the rule.