April 29, 2021
The U.S. Environmental Protection Agency tightened the use of a regulatory exemption that allowed toxic PFAS chemicals to receive automatic approval for production if toxicity reviews were not completed within 30 days.
Under the Toxic Substances Control Act, new chemical substances must undergo a review to determine whether they present an “unreasonable risk of injury to health or the environment.”
But some categories of chemical substances are eligible for a “low volume exemption,” where they can skip a full chemical review if the company producing the chemical promises to produce 10,000 kilograms of the chemical or less.
Under the exemption, the EPA has 30 days to perform an expedited review of whether the chemical can cause serious human health effects or environmental effects.
If the EPA has not taken any action to stop the exemption, the chemical manufacturer “may consider its exemption approved and begin to manufacture the new chemical substance,” according to the law.
The EPA’s Office of Pollution Prevention and Toxics said the exemption allowed PFAS chemicals to enter the U.S. market despite serious health risks.
PFAS are a family of thousands of chemicals historically used to produce waterproof, fireproof and grease-resistant products since the 1940s.
Chemicals in the PFAS family have been linked to a series of adverse health effects like increased risk of kidney and testicular cancer, decreased vaccine response, increased cholesterol levels, decreased birth weight in newborns and increased risk of high blood pressure or pre-eclampsia in pregnant women.
The EPA said that performing adequate assessments of PFAS and its various sub-classes can be too challenging to perform in 30 days due to “scientific complexities.” The agency said it will use its statutory authority to deny exemption requests when reviews cannot be completed in 30 days.
“While EPA will consider each LVE application individually, the agency generally expects that pending and new LVE submissions for PFAS would be denied. Doing this will allow the agency additional time to conduct a more thorough review through the pre-manufacture notice review process and, as appropriate, put measures in place to mitigate the potential risk of these chemicals as the agency determines whether to allow them to enter commerce,” the agency said in a statement.
Besides the low volume exemption, the EPA has also taken action to rein in the use of other loopholes that allow companies to produce PFAS and other chemicals without full health and environmental reviews.
The agency said it would stop issuing TSCA determinations based on proposed significant new use rules and would require chemical manufacturers to identify potential unreasonable risks to workers.
Previously, the EPA would issue safety determinations for a new use of a previously reviewed chemical even when the chemical’s effects were not reviewed in its new role.
Environmental advocacy groups have petitioned the EPA to close dozens more loopholes allowing PFAS manufacturers to skirt regulations intended to protect public health and the environment.
“The nation is awash in PFAS. Yet EPA continues to approve new PFAS even though it knows the risks such chemicals may pose to human health and the environment,” said Earthjustice staff attorney Suzanne Novak. “Even worse, EPA allows companies to circumvent the regular safety review process for new PFAS in violation of TSCA and in ways that have already impacted entire communities. That must stop.”
EPA administrator Michael Regan has promised to make tackling PFAS contamination one of his priorities.
This week, he established a council of senior career EPA officials to help develop the agency’s strategy for dealing with PFAS contamination.
Regan told the U.S. Senate Environment & Public Works Committee Wednesday that the EPA was “moving ahead” with establishing a PFAS drinking water standard, which would set the maximum amount of PFAS allowed in drinking water, and was looking into designating PFAS as a hazardous substance.
Indiana University associate scientist Marta Venier and other researchers have called for the EPA to consider the thousands of PFAS chemicals as a single class, a move which could make regulating them much more efficient.