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By Pat Rizzuto
The EPA says it eliminated the backlog of new chemicals it’s reviewing, drawing praise from an industry that would still like to see the agency do more to ensure chemical innovations reach the marketplace.
The Environmental Protection Agency said 382 new chemical notices were under review as of Aug. 1. That contrasts with about 1,000 earlier this year. The agency says its typical new chemical case load is about 300 notices.
Clearing the backlog is a crucial first step, but the agency and new chemical manufacturers must finish their negotiations before many of the chemicals the EPA reviews can be made, an industry consultant and former agency chemicals official has said. The chemicals industry, nonetheless, cheered the progress the EPA has made since the Toxic Substance Control Act was amended in 2016, prompting changes that resulted in the backlog.
“EPA deserves our congratulations and thanks,” Martha Marrapese, an attorney with the Washington office of Wiley Rein LLP, told Bloomberg BNA. “Reaching this milestone reflects a lot of hard work on the part of EPA staff and industry as we all learn how to navigate the new TSCA landscape.”
The EPA’s goal is to “ensure a new chemicals program that is both protective of human health and the environment, while also being supportive of bringing new chemicals to market,” Scott Pruitt, the agency’s administrator, said in a statement.
However, environmental groups accused the EPA of bowing to pressure from chemicals manufacturers with Richard Denison, the Environmental Defense Fund’s lead senior scientist, in a blog post accusing the “industry-friendly” administration of circumventing the toxics law’s intent.
Jon Corley, a spokesman for the American Chemistry Council, called the EPA’s announcement “a critical step.”
However, “there is still work to be done to completely clear the backlog and prevent it from reoccurring. We strongly support the administrator’s commitment to a more predictable and transparent process for decision-making,” Corley said in an email. “U.S. businesses, jobs, innovation and competitiveness depend on the success of a fully functioning new chemicals program as envisioned by Congress when it passed the law.”
The Toxic Substances Control Act, or TSCA, was substantially amended in June 2016, but changes to the law’s new chemicals provisions prompted a temporary backlog of hundreds of new chemical notices.
Chemical manufacturers must submit such notices before they can make for sale a new chemical or certain new microbes that can be used to make new chemicals. The types of new chemical notices that EPA reviews include: premanufacture notices (PMNs), microbial commercial activity notices (MCANs), significant new use notices (SNUNs), and notices requesting an exemption from the need to file a PMN because, for example, only very small volumes of a new chemical will be manufactured.
Lynn Bergeson, managing partner with Bergeson & Campbell, P.C. in Washington, also praised the EPA’s progress. That law firm will review EPA’s latest statistics to assess the agency’s progress completing negotiations it undertakes with chemical manufacturers after it decides whether or not a new chemical might pose an unreasonable risk.
During an Aug. 2 webinar, Charles Auer, a senior regulatory and policy adviser with Bergeson & Campbell, voiced a concern Bloomberg BNA has heard from attorneys and other consultants.
When the EPA reaches its decision about a new chemical it counts that as a completed action, Auer said during a webinar organized by Bergeson & Campbell and Bloomberg BNA. The agency’s decision is critical to determining whether a new chemical may enter commerce, but it’s not the final action, he said.
Typically the agency and the manufacturer that would like to make the new chemical then undertake negotiations, according to Auer, who worked at EPA for more than 30 years including directing the agency’s chemicals office. If the EPA finds a new chemical might pose an unreasonable risk to people or the environment it typically negotiates one or more of several options with the manufacturer. These options have typically included having the company provide more toxicity or exposure data before or after a new chemical would be sold, or allowing the chemical to be sold but restricting its uses.
Counting only EPA’s decision doesn’t reflect the full process, Auer and colleagues wrote in a recent Insights article in Bloomberg BNA.
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