EPA Releases Several Rules and a Draft Scientific Integrity Policy

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

In the first quarter of 2024, EPA released a draft scientific integrity policy and several rules aimed at limiting people’s exposure to hazardous substances. The Supreme Court heard oral arguments in several cases that could severely hamper agencies’ ability to regulate based on evidence and expertise. CDC acknowledged that draft guidelines on controlling infections in hospitals required more work, but its guidance on respiratory viruses drew criticism for downplaying COVID-19 risks.

EPA releases draft scientific integrity policy and several rules

In January, EPA released its draft scientific integrity policy for public comment. The draft policy addressed a concern that scientific integrity advocates raised regarding a provision that appeared in the model scientific integrity policy (which was developed by an interagency working group) and used by the Department of Health and Human Services and the National Institutes of Health in their draft policies. The provision prohibits agency scientists from making statements that “could be construed as being judgments of, or recommendations on” agency policy unless they have secured prior approval. EPA retained the “construed as” language, which could be abused by bad-faith actors claiming to interpret factual statements as policy judgment, but it substantially narrowed the scope by specifying that the limitation only applies to scientists speaking in their official capacities. Advocates recommended that other agencies whose in-process policies contain this provision adopt EPA’s language to narrow its scope.

Eight organizations submitted a comment on the EPA draft policy that recommended changes and praised several aspects of the draft policy, including its provisions on the expression and documentation of differing scientific opinions, restrictions on political interference in cost-benefit analysis, provisions for federal advisory committee transparency, and delineation of responsibilities for public affairs officials. Recommendations included clearer delineation of responsibilities to support effective scientific integrity work; more explicit provisions for procedures to investigate allegations; stronger commitments to diversity, equity, inclusion, and accessibility; and mechanisms for addressing allegations that involve multiple agencies and/or high-level officials. Representative Paul Tonko—who last year reintroduced the Scientific Integrity Act to codify into law requirements for agencies to adopt and enforce scientific integrity policies—wrote to EPA commending the “substantial step forward” that the policy represents and making recommendations to improve it.

With the 2024 elections approaching, EPA faces the possibility that a new administration might substantially change EPA’s direction and that a new Congress could use the Congressional Review Act (CRA) to undo rules the agency finalizes within the last 60 session days of the current Congress. Because Congress’s calendar fluctuates, the cutoff date typically falls sometime between April and June of each even-numbered year. Rules issued during the first quarter of 2024 should be safe from CRA attacks, and EPA finalized several: a review requirement for new or resumed manufacturing of PFAS; stricter limits on fine particulate matter air pollution; rules to limit methane releases by the oil and gas industry; Risk Management Program amendments to better protect communities from chemical disasters; a ban on the import and use of chrysotile asbestos; closure of a loophole that let petroleum refineries release unlimited emissions during natural disasters without liability; a final rule to reduce emissions of the cancer-causing gas ethylene oxide from commercial sterilizers; and new emissions standards for passenger vehicles and heavy-duty trucks.

Looking ahead: Additional EPA rules expected in the coming weeks include a limit for PFAS in drinking water.

Supreme Court hears cases that could shift power from agencies to judges

The Supreme Court heard oral arguments in several cases that could result in the judicial branch shifting power away from experts in federal agencies and into its own hands. This Court began eroding agencies’ ability to regulate based on the best available evidence with its West Virginia v. EPA decision in 2022. Now, it could go further.

The related cases Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce invite the Supreme Court to overturn the longstanding judicial doctrine of Chevron deference (named after the 1984 case Chevron v. NRDC), by which courts defer to reasonable agency interpretations of ambiguous statutes. Without Chevron, judges—rather than agency experts—would have the final word on regulations that Congress tasked agencies with developing based on their extensive relevant knowledge. In the Alliance for Hippocratic Medicine (AHM) case over the medication abortion drug mifepristone, the Court could decide whether judges or FDA experts should be able to make drug safety decisions whenever an ideologue or commercial competitor challenges a drug in court. The judgment could also deal a blow to agency regulations if the decision damages the State Farm precedent (from the 1983 case Motor Vehicle Manufacturers v. State Farm) that stops courts from second-guessing an agency’s judgment if the agency has a reasoned explanation for its decision.

If the Court uses one or more of these cases to weaken agencies’ power over the regulations laws task them with developing, a judgement for the plaintiffs in Corner Post Inc. v. Board of Governors of the Federal Reserve System could exacerbate the harm. Currently, the Administrative Procedure Act gives anyone injured by an agency action six years to file suit, and the clock starts when the agency publishes its final rule. Plaintiffs in this case argue that the clock should instead start when an entity first experiences harm. If the Court rules in their favor, that would mean that regulations could be challenged at essentially any time, because new businesses could keep forming and claiming injury. The specter of constant litigation would severely hamper agencies’ ability to develop and adopt evidence-based regulations.

The Court is deciding these consequential cases at a time of heightened scrutiny of the judicial branch. Revelations of lavish gifts to Justice Clarence Thomas and other members of the Court have raised concerns about possible bias. Calls are mounting for Senate Judiciary Committee Chair Dick Durbin to enforce the subpoenas the committee authorized in late 2023 for Harlan Crow and Leonard Leo, who are central to the financial networks contributing to Thomas.

Elsewhere in the court system, concerns about “judge shopping”—a practice of plaintiffs choosing to file their cases in jurisdictions where they expect to find a favorable judge, even if it’s not the most appropriate for their case—have prompted bipartisan calls for change. The Judicial Conference, a committee of judges that sets federal judiciary policy, responded with a policy requiring random judicial assignments in cases with national or statewide implications. However, it followed that announcement a few days later with guidance that made the policy sound optional. Legislation like the End Judge Shopping Act introduced last year by Representative Mikie Sherrill might be necessary to halt the practice.

Looking ahead: The Supreme Court typically waits until June to release decisions in its most high-profile cases.

CDC acknowledges need for strong hospital infection control but downplays COVID risk

In late 2023, CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) drafted new guidelines for hospital infection control that failed to fully incorporate the science on aerosol transmission of infectious diseases and the full range of effective measures for preventing disease transmission in healthcare settings. Public health experts and healthcare workers pushed back, including via petitions organized by National Nurses United (NNU) that urged CDC to reject HICPAC’s draft and develop a new one that “actively incorporates the expertise of and insights from frontline health care workers, their unions, patients, and public health experts—both in infection prevention and other fields with essential expertise, including industrial hygiene, ventilation engineering, respiratory protection, aerosol science, and occupational medicine and nursing.”

In January, CDC announced that, instead of simply adopting HICPAC’s version of the guidelines (as public health advocates feared the agency would), they had sent questions and comments back to HICPAC for additional considerations. The agency also stated that it was “working to expand the scope of technical backgrounds of participants on the HICPAC Isolation Guideline Workgroup and eventually among the committee members.” NNU praised the move and urged CDC to include union representatives of healthcare workers in the expanded workgroup.

Several public health experts criticized another CDC action when the agency released new respiratory virus recommendations that lumped COVID-19 with flu and RSV. For all three viruses, the agency suggests returning to normal activities when symptoms have been improving for at least 24 hours and any fever has gone, though they also encourage additional prevention strategies (masking, taking steps for cleaner air, etc.) for an additional five days. Although combining guidance for the three conditions makes for a simpler message, the move fails to recognize that COVID-19 is far more likely than the flu to be fatal, the virus causes long COVID in a substantial number of those infected, and infected people may spread the virus for more than five days. NNU criticized the recommendations.

Looking ahead: HICPAC is tentatively scheduled to meet on June 6-7.

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