Strengthening Transparency in Regulatory Science COMMENTS DUE April 17, 2020 EXTENDED to May 18, 2020

March 18, 2020

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(Environmental Protection Agency/Federal Register) This supplemental notice of proposed rulemaking (SNPRM) includes clarifications, modifications and additions to certain provisions in the Strengthening Transparency in Regulatory Science Proposed Rulemaking (“2018 proposed rulemaking,” Ref. 1), published on April 30, 2018. This SNPRM proposes that the scope of the rulemaking apply to influential scientific information as well as significant regulatory decisions. This notice proposes definitions and clarifies that the proposed rulemaking applies to data and models underlying both pivotal science and pivotal regulatory science. In this SNPRM, EPA is also proposing a modified approach to the public availability provisions for data and models that would underly significant regulatory decisions and an alternate approach. Finally, EPA 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.

DATES: Comments must be received on or before April 17, 2020.

The 2018 proposed rulemaking, as supplemented by this SNPRM and this accompanying preamble, describes how EPA will handle studies when data and models underlying science that is pivotal to EPA's significant regulatory decisions or influential scientific information are or are not publicly available in a manner sufficient for independent validation and analysis. The rule would not regulate the conduct or determine the rights of any entity outside the federal government.^[4]Rather, it exclusively pertains to the internal practices of the EPA.

Finally, EPA in the 2018 proposed rulemaking, as supplemented by this SNPRM and this accompanying preamble, does not propose to interpret provisions of a particular statute or statutes that it administers. Instead, in this action, EPA proposes a rule of agency procedure to establish an agency wide approach to handling studies when the data and models underlying EPA's significant regulatory decisions and influential scientific information are publicly available and when those data and models are not publicly available. Therefore, this is a proposed internal rule of agency procedure.

This internal agency procedure is intended to be consistent with the statutes that EPA administers and EPA plans to implement this procedural rulemaking in accordance with all applicable statutory and regulatory requirements. Indeed, as discussed in this SNPRM, EPA is also proposing options that would allow EPA to consider studies even if the underlying data and models are not publicly available. [See Section IV.] The Agency seeks comment on whether this approach may improve consistency between this proposed rulemaking and certain provisions of those statutes that refer to standards for data availability. Nonetheless, in the event the procedures outlined in the proposed rulemaking conflict with the statutes that EPA administers, or their implementing regulations, the statutes and regulations will control. Moreover, EPA is considering how to proceed, apart from this supplemental proposal, to establish regulations interpreting provisions of, and/or exercising substantive rulemaking authority delegated to it by programmatic statutes, to include one or more of those statutes cited as authority in the 2018 proposed rulemaking as clarified in this SNPRM.

Although this is a rule of internal agency procedure and EPA does not propose to interpret provisions of a particular statute or statutes that it administers, EPA is taking comment on whether to use its housekeeping authority independently as authority or in conjunction with the environmental statutory provisions cited as authority in the 2018 proposed rulemaking (as clarified in this SNPRM). The Agency continues to consider whether it is appropriate to rely on its authority in the above-reference environmental statutory provisions (potentially in conjunction with its housekeeping authority). The Agency will consider comments on this issue submitted in response to the 2018 proposal and in response to this SNPRM.

C. What action is the Agency taking?

EPA is issuing this SNPRM to clarify, modify and supplement certain provisions included in the 2018 proposed rulemaking in response to some of the public comments received on the 2018 proposed rulemaking (83 FR 18768), as well as to ensure consistency with the April 2019 release of the White House's Office of Management and Budget (OMB) Memorandum to the Heads of Executive Departments and Agencies entitled Implementation of the Information Quality Act (OMB M-19-15, Ref. 3). This memorandum is directly relevant to several of the provisions of the 2018 proposed rulemaking 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 is modifying the regulatory text initially proposed in the 2018 proposed rulemaking at 40 CFR 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, EPA is clarifying that the use of the terms “model assumptions” and “models” in the proposed regulatory text at 40 CFR 30.6 apply to the assumptions that drive the model's analytic results. EPA has modified the regulatory text at 40 CFR 30.6 to reflect this clarification. This approach is consistent with OMB M-19-15 (Ref. 3), which highlights the need to characterize the sensitivity of an agency's conclusions to analytic assumptions.

Second, EPA is proposing to expand the scope of this rulemaking to apply to influential scientific information ^[5 6]as well as significant regulatory actions. EPA is proposing to add definitions for “influential scientific information” and “pivotal science” at 40 CFR 30.2 that will pertain to the science underlying influential scientific information, which are not regulatory, and is making conforming changes to proposed 40 CFR 30.3, 30.5, 30.6 and 30.7. EPA is retaining the definition of “pivotal regulatory science” from the 2018 proposed rulemaking regulatory text.

Third, EPA is modifying, deleting and proposing new regulatory text in addition to proposing definitions for “influential scientific information” and “pivotal science” at proposed 40 CFR 30.2. EPA is deleting the first paragraph of the 2018 proposed rulemaking regulatory text at 40 CFR 30.2. EPA is deleting the definition of “research data” at 40 CFR 30.2. EPA is proposing definitions for the terms “Capable of being substantially reproduced”, “Data”, “Independent validation”, “Influential scientific information, ” “Model”, “Pivotal science”, “Publicly available” and “Reanalyze.” These revisions are intended to provide clarity on key terminology used in the regulatory text in the 2018 proposed rulemaking as well as in this supplemental proposal.

Fourth, EPA is deleting the 2018 proposed regulatory text at 40 CFR 30.10. This change is being made to be consistent with the deletion of “research data” in 40 CFR 30.2 because 40 CFR 30.10 would have required EPA to implement this rulemaking to be consistent with the definition of “research data.” With the deletion of Start Printed Page 15399“research data” from proposed 40 CFR 30.2, proposed 40 CFR 30.10 is no longer needed.

Fifth, EPA is proposing a modified version of the regulatory text at 40 CFR 30.5 from that proposed in the 2018 proposed rulemaking. Under this new approach to proposed 40 CFR 30.5, when promulgating significant regulatory decisions or finalizing influential scientific information, the Agency will only use pivotal regulatory science and/or pivotal science if the data and models are available in a manner sufficient for independent validation. 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.

As an alternative, EPA is proposing that under proposed 40 CFR 30.5, when promulgating significant regulatory decisions or finalizing 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. The Agency will identify those studies that are given greater consideration and will provide a short description of why greater consideration was given. 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. This proposal would apply to reviews of data, models, and studies at the time a rule is developed or influential scientific information is finalized, regardless of when the data and models were generated. See Section IV of this preamble for a description of these proposals.

Sixth, EPA is modifying 40 CFR 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, the EPA is proposing 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 rulemaking (as clarified in this supplemental proposal). The Agency 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). The Agency will consider comments on this issue submitted in response to the 2018 proposal and in response to this 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.

The 2018 proposed rulemaking solicited comment on all aspects of the proposed rulemaking. This SNPRM solicits comment only on the changes and additions to the proposed regulatory text discussed in this supplemental document. Comments submitted in response to this supplemental document that address aspects of the 2018 proposed rulemaking that are not addressed, altered, or replaced by this SNPRM will be deemed outside the scope of this supplemental action.

D. Why is the Agency taking this action?

EPA received extensive comment on the 2018 proposed rulemaking regarding the clarity of certain aspects of the proposed rulemaking and the challenges in making all dose-response data and models publicly available. The intent of this supplemental proposal SNPRM is to address certain concerns raised about the clarity of the 2018 proposed rulemaking; to clarify consistency with OMB M-19-15, OMB M-05-03 (Final Information Quality Bulletin for Peer-Review, Ref. 4), and Executive Order 13891 (Ref. 5); to propose an alternate 40 CFR 30.5 provision for availability of data and models underlying pivotal regulatory science and pivotal science, and to propose relying on 5 U.S.C. 301 independently or in conjunction with the environmental statutory provisions cited as authority in the 2018 proposed rulemaking (as clarified in this SNPRM). The Agency continues to consider whether it is appropriate to rely on its authority in the above-reference environmental statutory provisions (potentially in conjunction with its housekeeping authority). The Agency will consider comments on this issue submitted in response to the 2018 proposal rulemaking and in response to this SNPRM.

II. Applicability to Data and Models

As identified by some public commenters, the 2018 proposed rulemaking did not put its discussion of increasing access to the data and models underlying pivotal regulatory science into the context of the broader approach that EPA uses to evaluate the entire body of scientific literature—that is, before it identifies candidates for “pivotal regulatory science.” Under this regulation EPA would continue to use standard processes for identifying, evaluating, and reviewing available data, models, and studies. When the Agency has potentially identified multiple key studies or models of similar quality that could drive its subsequent decisions, the Agency will investigate the availability of the underlying data. If, for example, multiple high-quality studies exist but only two studies have data and models that are available for independent validation and reanalysis, EPA would only include those two studies as pivotal regulatory science and/or pivotal science in accordance with the 2018 proposed rulemaking. However, under the alternative approach in this supplemental proposal, EPA would consider using all available high-quality studies but give greater consideration to those two studies with data available for independent validation.

As highlighted in some public comments, the terms “dose-response data and models,” “dose-response models,” “models” and “model assumptions” are not used consistently throughout the regulatory text of the 2018 proposed rulemaking. For example, some parts of the regulatory text appear to limit applicability of certain provisions to only dose-response models.^[7]In others, the requirements would apply more broadly. EPA is now proposing a broader applicability. Transparency of EPA's science should not be limited to dose-response data and dose-response models, because other Start Printed Page 15400types of data and models will also drive the requirements and/or quantitative analysis of EPA final significant regulatory decisions and influential scientific information.

EPA is modifying the proposed regulatory text at 40 CFR 30.3, 30.5, 30.6 and 30.9 by deleting the term “dose-response,” except in one instance. In proposed 40 CFR 30.6, EPA is not deleting “dose response” from the sentence specific to parametric dose-response models. EPA is also removing “including assumptions of a linear, no-threshold dose response” from 40 CFR 30.6, because this could imply that the regulation is specific to those particular assumptions. This is not the intent of proposed 40 CFR 30.6.

Consistent with this broader approach to transparency, the proposed requirements of this rule would apply broadly to data and models underlying pivotal regulatory science and pivotal science which support significant regulatory decisions and influential scientific information, respectively, rather than simply to dose-response data and models. Some, but not the only, examples of information that would be considered to be data and models, in addition to dose-response data and dose-response models, include environmental fate studies, bioaccumulation data, water-solubility studies, environmental fate models, engineering models, data on environmental releases, exposure estimates, quantitative structure activity relationship data, and environmental studies. The proposed definitions of “data” and “models” are discussed more fully in Section III.B of this preamble.

In addition, EPA is clarifying that the use of the terms “model assumptions” and “models” in the proposed regulatory text at 40 CFR 30.6 apply to the assumptions that drive the model's analytic results, not to each model assumption used in the model. EPA has modified the regulatory text at 40 CFR 30.6 to reflect this clarification.

EPA requests comment on the applicability of proposed 40 CFR 30.3, 30.5, 30.6 and 30.9 to data and models. READ MORE

E.P.A. to Limit Science Used to Write Public Health Rules (New York Times)

COMMENT PERIOD BEGINS ON 'SECRET SCIENCE' PROPOSAL (Politico's Morning Energy)

CARPER DRAWS LINE BETWEEN COVID-19 AND SECRET SCIENCE: (Politico's Morning Energy)

EPA EXTENDS 'SECRET SCIENCE' COMMENT PERIOD: (Politico's Morning Energy)

SCIENTISTS HOLD PUBLIC HEARING ON TRANSPARENCY RULE: (Politico's Morning Energy)

SPEAKING OF EPA AND THE COURTS: (Washington Examiner's Daily on Energy)

Excerpt from Politico's Morning Energy: COMMENT PERIOD BEGINS ON 'SECRET SCIENCE' PROPOSAL: The 30-day comment period for EPA's proposed scientific transparency rule begins today, Pro's Annie Snider reports. The supplemental notice to the Trump administration's rule entitled "Strengthening Transparency in Regulatory Science" (Reg. 2080-AA14) is teed up to run in today's Federal Register. The agency unveiled the controversial rule earlier this month. READ MORE

Excerpt from Politico's Morning Energy: EPA EXTENDS 'SECRET SCIENCE' COMMENT PERIOD: EPA will give the public an extra month, until May 18, to comment on its re-proposed science transparency rule, Pro's Alex Guillén reports. Democrats and environmental groups had complained the agency had limited comment in the midst of the coronavirus pandemic. (Reg. 2080-AA14)

It's worth noting that groups have called on EPA to extend comment periods for all of its rulemaking, with some requesting far lengthier comment periods. "While this extension is a step in the right direction, it is unreasonably optimistic to expect the COVID-19 public health crisis to subside by mid-May," said House Science Chairwoman Eddie Bernice Johnson. "I reiterate my request for a comment period of at least 109 days, to match that of the original proposed rule." READ MORE

Excerpt from Politico's Morning Energy: SCIENTISTS HOLD PUBLIC HEARING ON TRANSPARENCY RULE:The Union of Concerned Scientists will hold its own virtual public hearing today on EPA's re-proposed science transparency rule because the agency will not hold one on the rule, which was unveiled last month. Participants will include New York Rep. Paul Tonko and William Reilly, former EPA administrator under President George H.W. Bush. UCS said it will submit all the public comments to EPA. The agency earlier this month extended the public comment period, originally just 30 days, until May 18. (Reg. 2080-AA14). READ MORE

Excerpt from Washington Examiner's Daily on Energy: SPEAKING OF EPA AND THE COURTS: A federal appeals court ruled Tuesday the EPA’s directive barring grant recipients from its scientific advisory boards is unlawful, because the agency didn’t adequately explain why it was changing its policy and why it was adopting an approach contrary to recommendations from the Office of Government Ethics. The D.C. Circuit’s opinion said the EPA’s failure to explain was “especially glaring given that the prior regime existed, in part, for the very purpose of facilitating the critical role played by EPA’s scientific advisory committees.” The ruling is the third court loss for the EPA on this policy in recent weeks.