FDA proposes mandatory notifications for GRAS food substances
The US Food and Drug Administration on Monday proposed requiring companies to notify the agency when they determine that a substance added to food is “generally recognized as safe,” or GRAS.
The move would change the agency’s voluntary GRAS notification program into a mandatory one. Companies currently can make their own GRAS determinations and introduce substances into the food supply without notifying the FDA.
The proposal stops short of the more sweeping GRAS reforms that the FDA had floated earlier this year, which included requiring companies to submit safety information before marketing any new food substances.
The proposed rule would not require the FDA to approve GRAS substances before they enter the market. Companies would continue to make an initial GRAS determination and could market products that contain GRAS substances before and during the notification process. Notifications to the FDA would provide a substance’s identity, manufacturing method, intended uses, exposure information, and the basis for the GRAS conclusion, but companies would not necessarily have to include underlying safety data.
Acting FDA commissioner Kyle Diamantas says in an Aug. 10 press release that the change would “close critical information gaps” and give the FDA “greater visibility into substances entering the food supply.” In March, FDA food chemical safety chief Mark Hartman told C&EN that “no one knows” how many GRAS substances have entered the market without FDA review.
The proposal also addresses substances already on the market under companies’ existing GRAS determinations. Manufacturers would have 1 year after the rule takes effect to make streamlined submissions identifying those substances and their uses. The FDA would publish the information and could later require a full GRAS notification, including supporting safety information, if it determines that more scrutiny is warranted.
Industry representatives told C&EN in March that reconstructing decades-old GRAS determinations could impose a significant burden on companies.
Law firm Holland & Knight says the FDA’s authority to impose mandatory notification could face legal challenges, given the agency’s previous position that such a requirement would need congressional authorization.
The rule’s comment period runs through Dec. 9, with mandatory notifications proposed to begin 18 months after the final rule takes effect.
—Joe Beeton, special to C&EN
Court approves $2.5 billion New Jersey PFAS settlement with DuPont and 3M
A federal district court approved a $2.5 billion settlement on Aug. 7 between the state of New Jersey and per- and polyfluoroalkyl substances (PFAS) manufacturers DuPont, Corteva, Chemours, and 3M.
“For years, corporate polluters have profited from ‘forever chemicals’ while causing untold damage to our communities—endangering the health of our kids, contaminating the water we drink, and exposing our first responders to dangerous carcinogens,” New Jersey attorney general Jennifer Davenport says in a press release. “Today’s landmark settlement cements New Jersey’s national leadership in the fight against forever chemicals and is a critical first step in undoing the damage DuPont and 3M have caused to our state.”
The settlement is a result of several PFAS lawsuits against DuPont and 3M in the state, according to the press release, including litigation regarding DuPont manufacturing sites and statewide litigation regarding aqueous film-forming foam. New Jersey previously secured $427 million from Solvay and Arkema to settle PFAS lawsuits.
The more than $2 billion set to be paid by DuPont and its affiliates, Chemours and Corteva, is the largest environmental recovery by a single state, according to Davenport. The state will use up to $895 million for PFAS remediation by drinking-water systems and local governments as well as restoration of damaged land and water, including areas around four current and former Chemours sites. DuPont and its affiliates will also spend up to $1.2 billion to remediate the four industrial sites without the use of public funds.
Of the $450 million to be paid by 3M, $60 million will go toward remediating DuPont’s Chambers Works site, where 3M supplied PFAS until 2001. The rest will fund PFAS remediation and restoration of natural resources around the state.
The settlement payments from DuPont and its affiliates, as well as 3M, will be made over 25 years.
—Bec Roldan, special to C&EN
California starts phase-out of the herbicide paraquat
The California Department of Pesticide Regulation announced Monday that the state has started a phase-out of the use of products containing paraquat dichloride. The herbicide is classified by the US Environmental Protection Agency as “highly toxic,” and many scientific studies have linked exposure to the compound to Parkinson’s disease and other health problems.
All companies that make paraquat-containing herbicides have canceled their product registrations in California, meaning they can no longer ship those products to the state. State-approved dealers can still sell their existing stock of paraquat herbicides for 2 more years.
“For years, communities have fought to end the use of paraquat, a weedkiller associated with negative impacts to human health and wildlife,” California secretary for environmental protection Yana Garcia says in a statement. “California will keep moving toward pest management practices that protect health and our ecosystems.”
Vermont became the first state to ban the use of paraquat, by passing legislation in May of this year. The state had expected to start phasing down its use in July.
The agrochemical company Syngenta, which had been the primary manufacturer of paraquat, announced in March that it would stop making the herbicide. It closed its only paraquat-manufacturing facility in June.
Over 6,500 pending lawsuits against Syngenta, Chevron USA, and other paraquat companies have been filed by people who claim they’ve been harmed by the herbicide. In 2021, Syngenta settled other cases with a $187.5 million agreement. But the company still says that paraquat is safe when used according to label instructions.
In January, EPA administrator Lee Zeldin announced that the agency would reassess the safety of paraquat herbicides. This move followed a review in November 2025 that found paraquat’s potential to evaporate from treated fields may be higher than previously thought.
Environmental groups have been pressing for California to ban paraquat since 2022. The state began a reevaluation of paraquat in November 2024, which required the manufacturers to submit new scientific evidence on unknown health and environmental risks by June 5, 2026. Instead of submitting scientific studies, companies canceled their product registrations of paraquat-containing herbicides. As of Aug. 6, all companies registered with the state had voluntarily withdrawn their registrations.
—Leigh Krietsch Boerner
