On March 18, 2020, EPA published a supplemental notice of proposed rulemaking to amend EPA’s 2018 proposed rule, Strengthening Transparency in Regulatory Science. After an extension, the comment period for the supplement is open until May 18, 2020. In this post, I review the supplement’s lack of a legitimate rationale, shortcomings with its stated legal authority, and legal issues EPA would face when implementing a final version of this rule.
EPA originally proposed this rule in 2018, seeking to prohibit the agency from relying on scientific studies in regulatory actions if the studies’ underlying data could not be made publicly available. If finalized, it will threaten EPA’s ability to set key pollution standards by arbitrarily limiting the science on which EPA can rely. EPA claims the rule will increase transparency without defining transparency or explaining how its requirements would facilitate EPA’s use of high-quality science, improve upon EPA’s current peer review process, or enhance public engagement already required for rulemaking and other significant actions.
The proposed rule included many ambiguous or contradictory sections. A draft report on the 2018 proposal from EPA’s own Science Advisory Board states, “[The Science Advisory Board] finds that EPA has not fully identified the problem to be addressed by the Proposed Rule.” The supplement purports to answer some of the objections and questions raised in the nearly 600,000 comments EPA received on the 2018 proposal. Notwithstanding those objections, the supplement alters the 2018 proposal by expanding the reach of the rule. Like the original, the supplement doesn’t provide credible justifications for undertaking the rulemaking and raises additional legal and scientific concerns.
EPA outlines the following changes in the supplement:
- Broadening the reach of the rule to affect all data and models rather than only dose-response data and models;
- Expanding the scope to cover all “influential scientific information” (information from the agency that substantially impacts public policy or private sector decisions) in addition to regulatory actions;
- Allowing the agency to rely only on scientific studies that can be independently validated through tiered access to the data, even if the data cannot be made fully publicly available;
- Clarifying that the administrator could consider the age of data and models when deciding to grant an exemption to the public availability requirements;
- Defining key terms, including “independent validation,” “publicly available,” and “reanalyze;”
- Proposing an alternative rule under which the agency would weigh studies differently depending on whether the underlying data and models can be independently validated.
EPA also seeks comment on its authority to pursue this rulemaking. In the original proposal, EPA relied on eight of its substantive statutes, such as the Clean Water Act and Clean Air Act, to issue this regulation. Now, EPA is considering relying solely or partially on the “housekeeping” statute, which authorizes agencies to handle internal affairs and preservation of records. EPA first introduced this new authority when it extended the comment period for the 2018 proposal.
The Proposal Still Lacks a Viable Rationale
Though EPA offers new definitions and clarifications in the supplement, EPA still doesn’t explain why its chosen form of transparency would improve EPA’s science-based decision making or solve a regulatory problem. Rather than offering a legitimate scientific or regulatory reason for this rule, the language in the supplement makes it clear that the rule is intended to benefit external stakeholders, not EPA.
In the supplement, EPA clarifies that by “publicly available,” EPA means that “the underlying data and models are available in a manner sufficient for independent validation either because the information is publicly available or available through tiered access….” EPA further explains that “[these] 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….” (emphasis added).
EPA’s focus on third-party independent validation by “stakeholders” suggests that the proposal was created to give industry access to the data underlying studies that compel stronger pollution standards. The rule would allow stakeholders, including those who lack scientific expertise, to manipulate the data to create doubt about a pivotal study. Yet EPA doesn’t explain why allowing stakeholders to reanalyze data would improve EPA’s ability to fulfill its statutory duties, or how EPA would evaluate any reanalysis. This is likely because there are no viable explanations. If EPA is using peer-reviewed studies, then they have already been vetted by the scientific community and by EPA career experts. EPA’s failure to connect how third-party reanalysis would help EPA use or understand peer-reviewed studies highlights the proposal’s arbitrariness.
The Alternative Weighting System is Arbitrary and Unnecessary
The supplement introduces an alternative approach that reinforces the rule’s arbitrariness, especially in light of EPA’s existing authority. Under the alternative, EPA could consider all studies but would give greater weight to studies that could be independently validated in accordance with the supplement’s requirements. Yet the rule doesn’t explain why greater weight should be given to studies that go through the rule’s independent validation process. It’s arbitrary to give greater weight to one study based on data transparency factors when considering two, otherwise equal peer-reviewed studies. And there is no connection between weighing studies this way and EPA’s statutory mandates. EPA already has the authority and obligation to weigh studies on their scientific merits. As things stand today, EPA can explain that a study is less persuasive by pointing to confidential data as a reason. The agency doesn’t need to issue this rule to make those kinds of determinations. All of this makes it clear that this proposal is not intended to improve EPA’s decision-making.
EPA Improperly Relies on a Procedural Authority
Ignoring its obligation to base actions on the merits of science and policy considerations, EPA now argues that the proposal is nothing more than an “internal rule of agency procedure” authorized by EPA’s “housekeeping authority.” EPA seeks comment on whether this authority is sufficient or whether it must be used in conjunction with other statutes.
Agencies’ housekeeping authorities derive from 5 USC §301 – a statute passed in 1874 with origins dating back to George Washington’s presidency that gives executive branch offices the authority to create internal agency procedures. The statute narrowly authorizes agencies to issue procedural regulations governing departmental affairs, not the content of an agency’s policy or governance action.
The statute states:
The head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property. This section does not authorize withholding information from the public or limiting the availability of records to the public.
EPA’s proposal and the supplement do not fit within the agency’s routine interpretation of this statutory authority. For example, in July 2019, the Trump EPA issued a regulation that partially relied on this housekeeping authority and more accurately reflects its limited scope. In that rule, EPA revised regulations related to research involving human subjects. The rule covered research conducted or sponsored by EPA and external research submitted to EPA. For the sections of the rule affecting agency-led research, EPA relied on its housekeeping authority. For the sections related to research submitted to EPA, EPA relied on authority granted to the agency in two substantive statutes. This distinction makes sense. The housekeeping statute could cover guidelines for internal research; it could not authorize guidelines related to independent research used by the agency. EPA has the authority to issue those guidelines only to the extent they affect the agency’s broader statutory mandates and thus must rely on those authorities, rather than its housekeeping authority.
Because the proposed Strengthening Transparency in Regulatory Science addresses the results of scientific studies and the manner in which EPA applies those results in carrying out its statutory mandates, the housekeeping statute is irrelevant. EPA frames the proposal as “[describing] how EPA will handle studies when data and models…are not publicly available in a manner sufficient for independent validation and analysis.” (emphasis added) If “handling” were simply a matter of filing studies, then EPA’s statutory “housekeeping” prerogatives would apply. But the proposal reaches beyond EPA’s handling of studies and would allow the agency to refuse to consider studies that would compel the agency to reach an unwanted result.
Furthermore, because this rule would deviate from EPA’s statutory requirements to rely on sound science, it cannot be authorized under 5 USC §301. As the Attorney General of New York and 15 other states attorneys general pointed out in their comments on the original proposal, “5 U.S.C. § 301 is ‘simply a grant of authority to the agency to regulate its own affairs,’ not a general, independent basis for deviating from a specific statutory directive or limiting the scope of other statutes. See Chrysler Corp. v. Brown, 441 U.S. 281, 308-12 (1979).”
Relying on Additional Statutory Authority Will Not Save This Proposal
EPA also seeks comment on whether it should rely on its housekeeping authority in tandem with other statutory authorizations. As many commenters explained in their responses to the original proposed rule, the rule conflicts with many of the statutes EPA administers. Using these statutes as additional authority will not save the rule from its lack of legal authority.
Let’s look at one example that is explicitly mentioned in the original proposal. The Clean Air Act requires that EPA rely on the best available science when setting national air quality standards: “Air quality criteria for an air pollutant shall accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare….” (emphasis added). EPA must give the appropriate consideration to leading, peer-reviewed studies to follow Congress’ intent that the air quality standards “reflect the latest scientific knowledge.” The statute does not give EPA the option of choosing to give less weight to a study based on an arbitrary factor, and the proposal does not explain why the availability of a study’s raw data affects its quality. By following this rule, EPA would be violating its Clean Air Act duty to rely on the best available science.
EPA potentially recognizes this contradiction, or at least understands that the rule’s implementation may be limited by EPA’s substantive statutes. In the supplement, EPA states “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.” At face value, this should mean that EPA would not be able to implement this rule when undertaking any action that requires EPA to use sound science. But if that’s true, it’s difficult to understand how EPA would be able to apply this rule at all given the numerous scientific requirements explicitly included in EPA’s substantive statutes. Would the administrator decide when the rule applied? Would EPA argue that the new tiered approach comports with its other statutory mandates? Would EPA automatically exempt certain rulemakings from these requirements? If so, would data from the same study need to be made available in some actions but not others?
It’s also unclear whether EPA truly intends to follow this caveat. It seems unlikely that EPA would go through the trouble of publishing this rule and then choose to severely limit its applicability by continually following controlling statutory language.
Though the supplement begins to answer some questions, it raises many concerns, starting with EPA’s new characterization of the rule as internal and procedural. It repeats the original proposal’s failure to present a strong case for EPA’s authority to issue this rule, and it fails to explain how the rule would benefit EPA or be lawfully implemented. There are several other troubling aspects of the supplement, including its broadened scope. Keep an eye out for future EELP analysis about other legal issues raised and for responses by scientists on the scientific implications of these proposals.
For more information, please see our series on the 2018 proposed rule:
- Science Advisory Board Draft Reports Reviewing Four Major Proposed Rules
- EPA is Planning to Limit the Science It Considers
- Legal Shortcomings in EPA’s So-Called “Secret Science” Proposed Rule
- Comments by Public Health Experts on the Secret Science Proposal
 In the original proposal, EPA states, “Using scientific information that can be independently validated will lead to better outcomes, and strengthen public confidence in the health and environmental protections underpinning EPA’s regulatory actions.” 83 Fed. Reg. 18,768 18,770 (April 30, 2018). EPA does not elaborate further on this conclusion.
Under the Trump administration, EPA has used its housekeeping authority to issue around ten final rules addressing internal agency operations. These include rules to update its system of records, modernize invoices, and revise regulations related to Freedom of Information Act requests.