The US Environmental Protection Agency is making major changes to the way it evaluates the safety of new chemicals, the agency announced March 29. To start, the EPA will assess the risks of all uses—known and potential—of a new chemical, and it will mandate necessary protections for workers.
The changes aim to better align risk assessments of new chemicals with the requirements of the Toxic Substances Control Act, the EPA says. The agency intends to make additional changes as necessary to ensure new chemicals do not pose unreasonable risks to human health and the environment.
Under the Trump administration, the EPA commonly justified approving new chemicals without addressing the risks of potential future uses of the chemical by issuing what is known as a significant new use rule (SNUR). A SNUR postpones risk assessment of a potential use until a company tells the EPA it will use a chemical in that way. The agency says that it will no longer rely on SNURs to exclude reasonably foreseen uses from its evaluation of new substances.
“Congress anticipated that EPA would review all conditions of use at the time it made safety determinations on new chemicals,” Michal Freedhoff, acting assistant administrator of the EPA’s chemicals office, said during a March 29 plenary session at the industry-sponsored GlobalChem Conference. “Under the Biden EPA, when our review leads us to conclude that one or more uses may present an unreasonable risk or when we lack the information needed to make a safety finding, we will issue an order to address those potential risks,” she said.
The EPA will also ensure that new chemicals do not pose a risk to workers. “When we identify a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment and hazard communication, we’ll no longer assume that those protections will be provided,” Freedhoff said. “We will mandate necessary protections,” she added.
Environmental groups welcome the changes. “By taking this step, EPA will reverse the illegal and unprotective approach the prior administration applied to hundreds of new chemicals over the last several years,” Richard Denison, a lead senior scientist at the Environmental Defense Fund, said in a March 29 blog post.
The American Chemistry Council, which represents the chemical industry, is concerned that the changes will lead to delays in getting new chemicals onto the market. Making the EPA’s process for approving new chemicals more efficient is one of the ACC’s top priorities this year, Chris Jahn, president and CEO of the group said in his opening remarks at the GlobalChem Conference. “Delays in the premanufacture notice review process can have a significant adverse effect on research and development of new sustainable chemistries as well as our ability to bring new innovative products to market,” he said.