The EPA is deciding whether it will review science that prompted one federal agency in 2017 to restrict use of a plastic softener in children’s toys.
The Environmental Protection Agency’s review, if granted, would determine whether toys made with diisononyl phthalate (DINP) pose an unreasonable risk to children under the nation’s primary chemicals law.
The softener has been used in plastic books, balls, and dolls, as well as in baby changing mats and cushions.
Exxon Mobil Chemical Co., the Evonik Corp., and Teknor Apex asked the agency to evaluate the risks DINP may pose when produced or when it’s in toys and other products.
They want their commercial customers and consumers to be confident in the safety of products made with DINP, said Eileen Conneely, who manages the American Chemistry Council’s (ACC) High Phthalates Panel.
Doubts about DINP’s safety have been raised in the past based on science that doesn’t meet the best available and other scientific criteria required by the 2016 Toxic Substances Control Act amendments, she said.
DINP has been reviewed by multiple international regulators, including Australia and Canada, and found safe for intended use, said Tom Flanagin, ACC’s director for product communications.
The European Union, however, forbids concentrations above 0.1% DINP to be in toys and articles which children can put in their mouths.
In 2017, the Consumer Product Safety Commission set that same concentration restriction for DINP in toys.
“DINP is used around the world in children’s toys and child care articles, and we feel that this use should be included in any comprehensive review by the EPA,” since this would be the first comprehensive risk assessment in the U.S., Flanagin said.
An EPA move to grant the companies’ request to analyze DINP’s use in children’s toys would be inconsistent with the agency’s other chemical risk evaluations, said Richard Denison, lead senior scientist for the Environmental Defense Fund.
The EPA’s other risk evaluations have assumed compliance with existing laws and regulations, Denison said. So presumably the agency wouldn’t consider a use that is actually restricted, he said, pointing to the move from the Consumer Product Safety Commission.
To examine that restricted use in response to the industry request would be “arbitrary, capricious, and inconsistent with the rationale the agency has used in other risk evaluations,” Denison said.
Also, TSCA doesn’t give the EPA the authority to review decisions made by the commission, Denison said.
“Even if EPA were to reach a different conclusion about the risks presented by DINP, such a finding would have no legal effect on CPSC’s restrictions,” the Environmental Defense Fund said in comments it submitted to the EPA about the manufacturers’ requested risk evaluations.
The laws implemented by the commission and the EPA mandate action based on different standards, Denison said.
The commission’s chemical and product regulations must ensure a “reasonable certainty of no harm to children, pregnant women, or other susceptible individuals with an adequate margin of safety,” EDF wrote in comments to the EPA.
Under TSCA, a chemical must not pose an “unreasonable risk.”
Decision by December
The EPA must decide by the end of this year whether it will grant the industry group’s request to have the agency evaluate the risks of DINP, and diisodecyl phthalate (DIDP), which Exxon Mobil—but not the other two companies—requested. Both chemicals are phthalates, which are used to make plastics more flexible.
The requests, which are being managed by the chemistry council’s panel, asked the EPA to examine similar ways the two phthalates are used.
The requests cover the use of both phthalates in children’s toys, although the Consumer Product Safety Commission lifted an interim restriction on DIDP in toys in 2017.
Other uses of the two phthalates the industry panel asked the EPA to evaluate include their manufacture; their use in inks, pigments, adhesives, sealants, and paints; and their use in polyvinyl chloride (PVC) that’s used for automotive parts, consumer goods, and building and construction equipment.
If the EPA decides to evaluate the risks of DINP and DIDP, the agency also will announce which ways a chemical is used and disposed of that it will examine. That means the agency could look at fewer or more uses of these two phthalates than the industry group requested.
The manufacturers will then have 30 days to decide if they want the EPA to proceed with the risk evaluation or not.
Companies have this option, because TSCA requires them to pay for risk evaluations the agency conducts at their request.
Because the EPA planned eventually to examine the risks of both phthalates, the tab the companies are responsible for starts with an initial payment of $1.25 million per risk assessment, according to fees EPA set in 2018.
When the risk evaluations are complete, the agency would bill the companies 50% of the actual costs of assessing the risks of the uses of both chemicals that they asked the agency to examine.
Taxpayers would be responsible for paying for any additional chemical uses the EPA decides to look at, but that the companies didn’t request.
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