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Liz Borkowski
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Roundup: Biden Administration Revamps Procedures for Reviewing Regulations

   

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This post is part of a series of quarterly roundups on scientific integrity.

In the fourth quarter of 2023, the Biden administration finalized updated procedures for conducting cost-benefit analysis and encouraging public participation in meetings about regulations. Advocates for scientific integrity commented on new draft scientific integrity policies. The Supreme Court responded to public concerns about its ethics by producing a Code of Conduct that lacks an enforcement mechanism, and it prepared to rule on cases that will determine whether agency experts or judges have more power over regulations and drug approvals.

On his first day in office, President Biden signed a memorandum that tasked the White House Office of Management and Budget (OMB) with improving and modernizing regulatory review. OMB—and specifically, the Office of Information and Regulatory Affairs (OIRA) within OMB—is responsible for reviewing significant regulatory actions, and it has faced criticism that it slows and weakens regulations that aim to improve public health. Early in 2023, OMB collected public comments on two draft initiatives as part of the modernization process. At the end of the year, they released final versions.

Circular A-4 guides agencies’ analyses of the benefits and costs of the rules they propose. The new version updates several elements: procedures for the “discounting” techniques applied to expected future benefits and costs to state them in current dollar terms; guidance for conducting distributional analyses that acknowledge benefits and costs can have different impacts on marginalized communities; clarification of the inclusion of effects outside the United States (while maintaining a primary focus on US impacts); and descriptions of effects that cannot (or should not) be assigned dollar values, such as the dignity benefits of requiring accommodations for people with disabilities. A companion document explains how OMB incorporated public input in these revisions. Plus, a newly announced Initiative to Advance the Frontiers of Benefit-Costs Analysis and Strengthen Government Decision-Making seeks engagement from researchers to inform future changes.

When reviewing proposed regulations, OIRA invites public input via meetings that outside parties request to present their views on the topic. These meetings—referred to as EO 12866 meetings after the Clinton-era executive order that described them—tend to be dominated by regulated industry. The Biden administration seeks to promote greater public engagement in OIRA’s regulatory review process, and its new guidance describes several steps the agency is taking to encourage meeting participation from a broad array of stakeholders: “making it easier to request meetings through OIRA’s online portal; providing plain language information on OIRA’s website to help individuals prepare for these meetings; posting a video how-to guide (in English and a Spanish version by OIRA Administrator Richard Revesz) on how to request meetings; and offering periodic and accessible public trainings on effective participation in these meetings.”

These new approaches could result in regulations based on a more comprehensive consideration of evidence. Changes to discounting in cost-benefit analyses could mean considering more of the long-term benefits of regulations that slow climate change, and greater attention to regulations’ distributional effects can support stronger protections targeted at structurally marginalized communities. In addition, a more inclusive approach to EO 12866 meetings could allow for the input of marginalized communities that are already seeing harms from sea level rise and changing patterns of severe weather.

Looking ahead: Anyone interested in scheduling a meeting with OIRA to give comments on a proposed regulation can use this website to do so. Researchers who can provide agencies with “relevant studies, datasets, or other information that would inform benefit-cost analysis” should view this fact sheet.

A process President Biden launched during his first week in office aims to ensure all agencies adopt scientific integrity policies that prohibit improper political interference in scientific research and prevent the suppression or distortion of scientific information. After an inter-agency working group developed a framework for scientific integrity policies, agencies have begun producing draft policies for public comment.

Eleven organizations submitted comments to the National Institutes of Health (NIH) about the NIH draft policy. The comment praises NIH for assigning efforts to promote diversity, equity, and inclusion to high-level officials, but highlights reports indicating NIH investigations into grantees’ spending and disclosures have led to the profiling and silencing of Asian American scientists and the chilling of collaboration between scientists in the US and China. Among the organizations’ advice to NIH is a recommendation that its revised policy assign the Chief Scientist the responsibility of identifying and addressing policies, practices, or procedures that have the effect of disproportionately burdening or discriminating against people from a marginalized group.

The comment to NIH also includes a recommendation that has appeared in other comments scientific integrity advocates have made to the White House Office of Scientific and Technology Policy and the Department of Health and Human Services: That the agency remove a requirement that scientists “refrain from making or publishing statements that could be construed as being judgments of, or recommendations on, [agency] or any other Federal Government policy.” Such a broad prohibition is open to abuse by bad-faith actors, who could claim to “construe” factual statements as judgments, and it risks making scientists decide that it’s easier to avoid speaking at all than to risk having their statements interpreted as policy recommendations.

Public Employees for Environmental Responsibility (PEER) noted that the draft scientific integrity policy from the Consumer Products Safety Commission not only contains that problematic prohibition, but does so in multiple places. PEER’s comment recommends that CPSC remove the provision.

Looking ahead: Several other agencies are likely to release their draft scientific integrity policies in early 2024.

In November 2023, the Supreme Court’s nine justices adopted a toothless Code of Conduct. The move indicated that the Court had heard the growing outcry about ethical problems that threaten its legitimacy, but it failed to allay those concerns because the code lacks an enforcement mechanism. “A code that has no enforcement mechanism, no imposed penalties, and merely rubber-stamps the justices’ own behavior is not an ethics code,” writes The Nation’s Elie Mystal. Jennifer Ahearn of the Brennan Center for Justice highlights both the absence of enforcement as well as a huge loophole in the guidelines for recusal (which the Code calls “disqualification”): Justices can decline to recuse themselves if they think their presence is necessary, even when their impartiality is questionable.

ProPublica has reported extensively on the lavish gifts Clarence Thomas and other justices have received from deep-pocketed individuals and organizations. Following publication of its stories on billionaire Harlan Crow and influential legal activist Leonard Leo, the Senate Judiciary Committee voted to authorize subpoenas of those individuals as part of the Committee’s ongoing investigations into Supreme Court ethics concerns. The Committee explained that information from these subpoenas will inform legislative efforts like the Supreme Court Ethics, Recusal, and Transparency (SCERT) Act.

While public confidence in the Supreme Court erodes, the Court is poised to decide more cases that could continue the trend of transferring power from experts in the executive branch to judges. In its previous term, the Court upended precedent with the West Virginia v. EPA decision that, instead of deferring to EPA’s expert judgment in Clean Air Act regulation as courts have done for decades, stated that courts can overrule agencies on “major questions.”

Now, with the Loper Bright Enterprises, Inc. v. Gina Raimondo and Relentless, Inc v. Department of Commerce cases (both of which involve regulation of herring fisheries), the Supreme Court has the opportunity to overturn the longstanding principle of Chevron deference, by which courts defer to reasonable agency interpretations of laws. In the case FDA vs. Alliance for Hippocratic Medicine, the Court will decide not only whether the agency’s moves to improve access to the abortion drug mifepristone will stand, but whether judges or FDA experts will have the final say over which drugs the public can access.

Looking ahead: The Supreme Court will issue its decisions in the Loper Bright/Relentless and Alliance for Hippocratic Medicine cases by the end of this term, likely in June.

Also:

Mike Johnson Is Now the Most Powerful Election Denier in Washington
131 Organizations Call on Congress to Strengthen Whistleblower Protections for Government Contractors
Whistleblower Prevails after Appeal Challenge by USGS
Patient, Consumer, and Public Health Coalition Letter to FDA Regarding Consumer Representatives in Advisory Committees
New Report Underscores the Need to Prevent Political Interference at US Public Health Agencies
The High Price of Overzealously Defending the US Research Enterprise against Theft by China
Here’s why MuckRock and POGO Had to Archive FOIAonline

New Resources:

Climate Science Legal Defense Fund toolkit: Climate Litigation Toolkit
Union of Concerned Scientists report: Strengthening and Diversifying the Federal STEM Workforce
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