EPA erred on science and law with methylene chloride ban, court rules
A worker strips paint off a car. A federal court of appeals ruled on Tuesday that “substantial evidence did not support EPA’s decision” to ban most uses of methylene chloride, a popular solvent that is used in various industrial, research, and consumer applications. Credit:
Shutterstock
The US Court of Appeals for the Fifth Circuit on Tuesday rejected a 2024 rule (PDF) by the US Environmental Protection Agency banning most uses of methylene chloride (MC), which is used for paint and coating removal, among other applications, and has been linked to a number of adverse health effects.
The EPA “discounted relevant human studies despite decades of MC’s use without significant adverse epidemiological findings; [and] (2) it assumed (contrary to law) no [personal protective equipment] use by workers, the most ‘at risk’ subpopulation, despite [Occupational Safety and Health Administration] requirements,” a three-judge panel found, among other alleged shortcomings in the agency’s actions.
The EPA in November 2016 announced MC as one of the first 10 chemicals prioritized for review under the Toxic Substances Control Act, which was updated by Congress earlier that year. EPA rules restricting four other priority chemicals are being challenged in federal appellate courts.
Separate lawsuits were filed in 2024—one by industry plaintiffs that said the EPA exceeded its authority, and one from the Sierra Club that said the agency did not go far enough. The two cases were ultimately consolidated. The EPA last November extended the deadline for laboratories to comply with the MC rule.
The Fifth Circuit panel vacated the EPA’s 2024 final risk management rule and associated risk determination and sent the matter back to the agency for further proceedings consistent with the opinion. The panel also denied the Sierra Club’s petition.
“For years, ACC has maintained that TSCA requires EPA to evaluate and manage risk based on individual conditions of use and the best available science, including consideration of existing workplace protections and real-world exposure information. The Court agreed . . . affirming that risk determinations must consider individual conditions of use, including proven workplace protections such as personal protective equipment,” the American Chemistry Council, one of three industry plaintiffs, says in a Sept. 16 statement.
But Samantha Liskow, lead counsel for Healthy Communities at the Environmental Defense Fund, says in a statement emailed to C&EN that the ruling “is wrong on the facts and wrong on the law, and many, including those most vulnerable, will now be harmed by this toxic chemical unless the administration acts.”
The EPA did not comment on the Fifth Circuit’s ruling beyond saying that it “is reviewing the decision.”
—Larry Pearl
NSF moves to revamp its grant-making process
The US National Science Foundation announced last week that it is updating its grant-making process, bringing it in closer alignment with the recent White House Office of Science and Technology Policy report Science: A New Golden Age.
In a Sept. 10 letter addressed to “The Science and Technology Community,” acting NSF director Brian Stone outlines changes to how the agency will both fund research grants and decide who to fund.
“The U.S. science and technology (S&T) enterprise has changed and America has entered a period of extraordinary scientific possibility,” Stone writes. “NSF is taking decisive action to meet this moment, introducing new and ambitious ideas that capitalize on the changes in the scientific ecosystem to advance our core mission.”
Some of the potential changes include experimenting with the grant review process. Traditionally, NSF grants undergo a merit review process where a panel of reviewers reach a consensus on whether to fund a project or not based on certain criteria.
But “other models exist that may be better suited to identify particular types of meritorious research activities,” the letter says. For example, a “golden ticket” approach would allow a peer reviewer to override their colleagues’ decision, pushing through a grant that would have otherwise been denied funding.
According to the letter, golden tickets could help surface higher-risk or more-controversial research that more-traditional peer review panels might reject.
The letter also acknowledges that while universities and traditional research institutions have been indispensable to US science, “some scientific goals require new forms of institutions.” The letter points to the agency’s X-Labs initiative, announced in May.
“We will also expand support for other emerging institutional forms, such as joint university-industry centers and research institutes that drive greater integration of foundational and applied research,” the letter says.
—Krystal Vasquez
FDA launches pilot program to accelerate clinical drug trials
The US Food and Drug Administration on Tuesday launched its Expedited Investigational New Drug (IND) Pilot Program, which aims to speed up the time from identifying a drug to starting a first-in-human clinical trial.
“Accelerating clinical trial timelines and eliminating regulatory hurdles to maintain American leadership in global medical innovation is a core priority for the [Donald J.] Trump Administration,” the FDA says in a press release.
“The same types of trials are completed much faster in China and Australia, threatening America’s leadership in scientific innovation,” the release continues.
Under the pilot, drug companies will partner “with qualified research institutions (QRI) that have scientific expertise to support efficient development of IND applications,” the FDA notes. The FDA will in turn review the individual components of the IND submissions as they are completed.
The pilot falls under Operation TrialBlazer, a cross-agency effort announced in June by the US Department of Health and Human Services to speed up the timeline for testing new drug candidates in the US.
Lucy Vereshchagina, executive vice president of science and regulatory advocacy at the industry group the Pharmaceutical Research and Manufacturers of America (PhRMA), calls the pilot “an important opportunity to drive American leadership in biopharmaceutical innovation.”
But the pilot “is just one opportunity to modernize the IND process,” Vereshchagina writes in a post on LinkedIn.
“The FDA should also pursue broader, risk-based IND and Investigational Review Board (IRB) reforms that support streamlining early development, strengthen FDA communication with sponsors and key stakeholders and enable appropriate activities to occur in parallel,” Vereshchagina’s post continues.
According to the FDA, “Drug sponsors and prospective QRIs will apply as a pair” and it “expects that 8–10 Sponsor-QRI pairs will be selected to participate in the initial pilot cohort.”
The deadline to apply is Oct. 30.
“Ultimately, the pilot will generate evidence to inform potential future approaches to modernizing FDA’s support for early-stage clinical development,” the FDA says.
—Larry Pearl
