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By Pat Rizzuto
A backlog of chemicals needing EPA approval has doubled in the past eight months—a jam chemical manufacturers say is significant to an industry that depends on creating new products.
The Environmental Protection Agency recognizes the backup and is working to address it. Possible changes include considering whether it needs to reinterpret requirements of the Toxic Substances Control Act, which was amended in June 2016.
Chemical manufacturers, which once found the EPA to be fairly predictable and reasonably quick in its reviews, are saying it is no longer predictable or quick.
“This is serious for industry as we rapidly need to bring new innovative systems to the market,” said Lynn Ann Dekleva, who manages product stewardship and regulations at DuPont.
The U.S. economy depends upon the innovation enabled by new chemistries, said Chemistry Council President Cal Dooley.
Without new chemicals, companies can’t make products that improve people’s lives or create new jobs, he said. It’s vital that the U.S. chemical industry remain at the forefront of innovation, Dooley said.
The backlog of industry requests to the EPA to make new chemicals has doubled from 331 to 658, he said. The EPA has allowed only 33 new chemicals to enter commerce since the law was amended, Dooley said.
“This is stunning for a program that has historically reviewed about 1,000 substances annually,” he said.
Those new chemicals, however, must be safe, Jonathan Black, senior policy adviser for Sen. Tom Udall (D-N.M.) said Feb. 22 during an American Bar Association meeting about TSCA. Udall, who introduced the amendments to TSCA and worked for years to secure bipartisan passage of the law, wanted the EPA to give a robust review before chemicals reach the market, Black said.
Wendy Cleland-Hamnett, EPA acting assistant administrator for chemical safety and pollution prevention, said that help is on the way. She spoke at the 2017 Global Chemical Regulations Conference in Washington organized by the American Chemistry Council.
“You have his commitment we’ll be working to get that process closer to where it should be,” Cleland-Hamnett said. She said EPA’s career staff met with Administrator Scott Pruitt on Feb. 22 to discuss the new chemicals program.
Chemical manufacturers have been required under the original and amended TSCA to submit a premanufacture notice to the EPA before they make, distribute or sell a new chemical in the U.S.
What’s new in the amended law, is that the EPA must review that notice and make an “affirmative finding” before the new chemical can enter commerce. The affirmative finding could conclude the new chemical would not pose an unreasonable risk. The EPA also could find, for example, that a possible health or ecological risk was addressed through data the would-be manufacturer provided or the agency could place restrictions on the chemical’s use.
Under procedures the EPA developed to comply with the original law, the agency considered ways a new chemical might be used before deciding whether it had concerns about the substance and different populations, including workers that might be exposed to it.
The TSCA amendments require the EPA to determine whether a new chemical’s “conditions of use” may present an unreasonable risk to potentially exposed or susceptible subpopulations including infants, children, women of childbearing age and workers.
The law said the EPA’s review must consider both intended and reasonably foreseen uses of new chemicals.
DuPont’s Dekleva said the EPA’s interpretation of the TSCA amendments has prompted a huge change.
Prior to the TSCA amendments, the EPA was prepared to allow a number of new chemicals to enter commerce. Now, the agency is demanding toxicity and other data for those very same chemicals, she said.
Those demands are arising at times because the agency is making unrealistic presumptions, such as the new chemical would be manufactured without any controls to protect workers or other potentially exposed populations, she said.
Cleland-Hamnett said the agency is discussing different ways to interpret what it must do to comply with the TSCA amendments, ways it should reach out to companies that have submitted premanufacture notices and information the EPA should providing companies to help smooth the review process.
Nearly “everything is on the table,” she said.
The one exception, Cleland-Hamnett said, is that the EPA must make an affirmative finding about a new chemical before it can enter commerce.
The agency held a meeting in December with chemical manufacturers, processors, states, health advocates and other interested parties to discuss concerns about and support for the agency’s approach to managing new chemicals since TSCA was amended.
Another meeting will be held in June, Cleland-Hamnett said.
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