US regulators move to speed up clinical trials
Clinical research coordinator Jacob Marquez (left) draws study participant David Parker’s blood in Oregon in 2022 as part of a clinical trial for a liquid-biopsy diagnostic technology. Challenges with US regulation have increasingly prompted companies to move their clinical trials to other countries, like China and Australia. Credit:
Associated Press
The US Department of Health and Human Services on Monday announced a cross-agency effort to speed up regulatory checkpoints in the clinical trials of new drugs.
The initiative, dubbed Operation TrialBlazer, aims to answer industry criticism that it can be difficult to obtain regulatory approval to test new drug candidates in the US. As a result, drug developers have increasingly moved to start clinical trials in other countries—especially China and Australia. In a commentary accompanying the new initiative, HHS secretary Robert F. Kennedy Jr. says this trend threatens American medical innovation.
The Food and Drug Administration says the plan could speed the path to first-in-human tests by 6–12 months. A roadmap document (PDF) attributes some early-stage clinical trial delays to FDA scheduling constraints and unclear guidance around the data that trial sponsors need to submit. The FDA says it will reduce the amount of pharmacology and toxicology testing and the chemistry and manufacturing data required to launch a Phase 1 safety trial.
At later stages in the drug development process, the FDA intends to reform institutional review board processes for multisite studies, make it easier to write and amend clinical trial protocols, and explore allowing larger incentives for patients who participate in clinical trials and their physicians. Earlier this year, the FDA also began a pilot study of real-time clinical trial monitoring.
Sharon Nachman, director of the office of clinical trials at Stony Brook University, told health-focused news outlet Healio that the initiative does not address understaffing at the FDA. She said, “We’ve lost a huge amount of people over the past year at the FDA, and I think that slows that process.”
The National Institutes of Health, which has historically funded thousands of clinical trials a year, plans to research ways to make trials more efficient and rigorous. The initiative also mentions Advanced Research Projects Agency for Health (ARPA-H) computational programs whose grantees are working on new ways of predicting drug safety and efficacy, and methods to integrate electronic health records and information from the national clinical trials database.
—Laurel Oldach
Chemours to pay $450 million in PFAS settlement across three US states
The US Environmental Protection Agency and Justice Department have reached a $450 million settlement, announced June 24, with the chemical manufacturer Chemours for alleged per- and polyfluoroalkyl substances (PFAS) pollution at the company’s facilities in West Virginia, North Carolina, and New Jersey.
“This settlement brings Chemours into compliance with the law and holds it fully accountable,” said Assistant Administrator Jeffrey A. Hall of the EPA’s Office of Enforcement and Compliance Assurance, in a press release.
The settlement addresses alleged PFAS discharges from four Chemours facilities that the US says violated the Clean Water Act, the Toxic Substances Control Act, and the West Virginia Water Pollution Control Act.
Chemours will pay a $22.5 million civil penalty, $280 million to test drinking water and provide clean water to communities near plants in West Virginia and New Jersey, and fund a $90 million PFAS mitigation program across the three states over the next 15 years. The company will also install $60 million of emission controls, such as treatment systems using granulated activated carbon, to reduce PFAS emissions in air and water at its West Virginia facilities.
Chemours has already taken steps to reduce PFAS discharges and emissions in North Carolina, following a 2019 settlement with the state’s Department of Environmental Quality.
Chemours wrote in a statement that these programs will help advance the company’s goal “to reduce process emissions of fluorinated organic chemicals by 99% or more by 2030.”
Under the settlement, Chemours will be able to continue manufacturing PFAS for “critical commercial and military applications,” according to the Justice Department.
Chemours has previously reached settlements related to alleged contamination from its production of PFAS, including a 2023 settlement with US public water systems that also involved DuPont and Corteva Agriscience.
North Carolina attorney general Jeff Jackson told the NC Newsroom that the current settlement “is an insult to the people of eastern North Carolina” and is “totally favorable to Chemours.”
Environmental groups, such as the Sierra Club, agreed.
“This order fails to support communities harmed by Chemours’ illegal discharges, with no consideration of the real and measurable impacts to public health, property values, or quality of life caused by Chemours’ willful violation of the public trust,” Erin Carey, deputy director of the North Carolina Sierra Club, said in a statement.
The agreement is not yet final, and the Justice Department will solicit public comments during a 30-day window that has not yet been announced.
—Bec Roldan, special to C&EN
EPA advances TSCA reviews for 5 chemicals, releases D4 peer review report
The US Environmental Protection Agency this month advanced multiple ongoing reviews of existing chemicals under the Toxic Substances Control Act (TSCA), releasing draft technical support documents for five industrial chemicals. It also published a final report from its Scientific Advisory Committee on Chemicals, or the SACC, on the agency’s draft risk evaluation of the silicone precursor octamethylcyclotetrasiloxane (D4).
The technical support documents—covering 1,1,2-trichloroethane, 1,2-dichloropropane, ethylene dibromide (EDB), trans-1,2-dichloroethylene, and tetrabromobisphenol A (TBBPA)—outline the EPA’s proposed approaches for assessing hazards, exposures, and risk before draft risk evaluations are issued for public comment.
The D4 report captures recommendations developed during the SACC’s December 2025 peer review of the EPA’s draft risk evaluation and released by the EPA this month, in which the SACC says the EPA’s D4 draft evaluation is directionally sound in places but incomplete and urges the EPA to broaden exposure assessment, improve environmental-release analysis, and strengthen documentation before issuing a final risk evaluation determining whether D4 presents an unreasonable risk under TSCA.
The EPA says it released technical support documents before publishing draft risk evaluations for the five chemicals because the assessments employ “unique and novel scientific approaches” in their human-health and environmental analyses, warranting earlier external scientific review through the SACC before the agency publishes draft risk evaluations. The EPA did not specify in the announcement which aspects of the assessments it considered novel. The EPA has scheduled the SACC review of the technical support documents for all five chemicals in the first week of August. Following that review, the EPA would revise the analyses as needed before issuing draft risk evaluations for public comment.
The substances under review represent established industrial chemistries with long regulatory histories. TBBPA, for instance, is used as a flame retardant; EDB is a legacy gasoline additive and industrial intermediate; and D4 is an intermediate used in the production of silicone found in everyday products. The three remaining chemicals are chlorinated solvents and industrial compounds that have drawn sustained attention over worker and environmental exposures.
—Joe Beeton, special to C&EN
17 states sue to avoid California’s plastics-recycling law
A California law on extended producer responsibility for single-use plastics has prompted a June 22 lawsuit by 17 Republican state attorneys general and the National Association of Wholesaler-Distributors, saying it violates both the California and US Constitutions by imposing California’s regulation of plastic packaging on the entire nation.
Led by Nebraska attorney general Mike Hilgers, the complaint (PDF) says the law “conditions access to California’s markets on radical changes to packaging design, production, and waste disposal—forcing businesses across the country to comply with California’s contrived environmental preferences,” according to Hilgers’s statement on the action. The group of attorneys general asked the US District Court for the Eastern District of California to stop California from enforcing the law’s regulations.
This is the second lawsuit filed against California’s S.B. 54, the Plastic Pollution Prevention and Packaging Producer Responsibility Act. The first was filed June 4 in California state court by the environmental advocacy groups the Natural Resources Defense Council, Californians Against Waste Foundation, and Oceana, Inc. In their complaint, the environmental groups say the loopholes in the law are so big they render plastics-recycling and -reduction goals useless.
California governor Gavin Newsom (D) signed the law in 2022, and it went into effect on June 1 of this year. It says that plastic products and packaging producers have to ensure their products are recyclable or compostable by 2032 and that they must meet California-set recycling rates.
—Leigh Krietsch Boerner
US weighs first seabed mining exploration in 4 decades
A Parapagurus sp. crab with a coral on its back walks across a field of ferromanganese nodules on the seafloor of Gosnold Seamount in 2021. The US is considering multiple applications for seabed mining in US waters as well as international waters. Credit:
National Oceanic and Atmospheric Administration via AP
The Bureau of Ocean Energy Management published a Federal Register notice on Tuesday seeking information from companies interested in leasing seafloor mineral rights in an area east of Virginia’s section of the Delmarva Peninsula.
Since 2025, the BOEM has also been evaluating mineral leases in waters near Alaska, American Samoa, and the Northern Mariana Islands. These projects could be the first ocean mineral exploration projects permitted by the US since 1984.
An April 2025 executive order directed federal agencies to advance the country’s seabed mining capabilities and expedite mining licenses. Odyssey Marine Exploration has already expressed interest in the Virginia minerals. The firm would use shallow-water dredging to dig sands potentially containing phosphate, zirconium, rare earth elements, and other metals, used to make fertilizers, nuclear-reactor components, and magnets for electric motors, among other things. The comment period for the potential Virginia lease closes July 23.
The BOEM is evaluating projects near the coast of the US, but companies are also interested in ocean minerals outside the US’s territorial waters, primarily in the deep waters of the Pacific Ocean.
US law gives the National Oceanic and Atmospheric Administration authority to grant mining licenses in international waters. But NOAA licenses could conflict with the International Seabed Authority, an international authority established by the United Nations Convention on the Law of the Sea. The Law of the Sea governs international waters, but the US has never signed on.
Extracting minerals from deep water will be much more challenging than shallow-water mining because there’s far less known about the deep ocean, says Ian Lange, a professor of mineral economics at the Colorado School of Mines. But he says those projects potentially offer greater rewards. “These nodules are higher grade,” he says. “Especially out in the Pacific Ocean, the ground is kind of covered with these… nodules.”
Since the April 2025 executive order, NOAA has received more than 10 applications for seabed mining licenses outside US waters, on top of the projects under evaluation by the BOEM. But lawmakers, scientists, and regulators are concerned that deepsea mining could severely damage marine ecosystems, with some groups calling for a ban.
