Rate of EPA Chemical Regulation Ramps Up Since Toxics Law Update

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By Pat Rizzuto

The Environmental Protection Agency has been regulating more new chemicals since the Toxic Substances Control Act was overhauled than it did before, according to a snapshot of its work over the past 11 months.

“It’s definitely harder to get a new chemical to market,” Charles Auer, a former senior EPA chemicals official told Bloomberg BNA. Auer now is a senior regulatory and policy adviser for the Bergeson & Campbell, P.C. law firm.

Auer, who spent 32 years working on chemicals at EPA, said he had expected the new law to double or triple the number of regulations the agency would impose on new chemicals, Instead the agency’s regulation rate is vastly exceeding his expectations.

Prior to the law’s update, about 10 percent of new chemicals were regulated in some way, Auer said. A snapshot of information the EPA released May 17 suggests about 50 percent of new chemicals are being regulated since TSCA was amended, he said.

Chemical Makers Withdrawing Requests

As the rate of regulation increases, chemical manufacturers are withdrawing more requests to make new chemicals than they did before the statute was revised, Dan Newton, a senior government relations manager with the Society of Chemical Manufacturers & Affiliates, told Bloomberg BNA.

Historically, companies withdrew about 5 percent of the new chemical requests they submitted to the agency, Auer said. The agency’s latest information suggests companies are withdrawing about 25 percent of their requests to make new chemicals, called premanufacture notices or PMNs, he said.

The increased rate of regulations combined with more manufacturers withdrawing their applications to make new chemicals may keep older chemicals, which traditionally raise more health and environmental concerns, on the market.

Liz Hitchcock, legislative director for the Safer Chemicals Healthy Families, thinks the EPA’s more stringent new chemical reviews are good.

One of the reasons the public was frustrated by TSCA–prior to its amendment in June 2016—is that new chemicals got very little oversight before they entered commerce, Hitchcock said.

EPA’s increased scrutiny “will build confidence in the agency’s ability to protect the public from toxic chemicals,” she said.

EPA Data

Auer, Hitchcock and Newton shared their insights regarding information the EPA provided Bloomberg BNA summarizing its new chemicals actions since TSCA was amended by the Lautenberg Chemical Safety Act on June 22, 2016. According to the EPA’s summary:

Between June 22, 2016, and May 9, the agency has allowed 255 new chemicals, new microbes or new uses of chemicals to enter commerce.

  •  Of these 255 cases, the agency determined that 84 new chemicals, microbes or chemical uses are “not likely to present an unreasonable risk.” That’s the safest conclusion the agency can make under the amended statute.
  •  Of the 255 cases, the agency decided 171 raised concerns or questions that could be addressed through consent orders negotiated between the company that submitted the new chemical notice and the EPA.
  •  As of May 9, 86 requests to make new chemicals or use chemicals in new ways had been withdrawn since the law was amended; 74 new chemical or new use notices had been sent back to the company that submitted them due to insufficient or invalid information.

Reducing Backlog

The EPA’s data also show that it has reduced its “backlog” of new chemicals that has built up since the Lautenberg Act’s amendments became law. The term “backlog” is shorthand for the greater than normal number of PMNs and other new chemical requests under the agency’s review since TSCA was amended.

As of May 9, 481 new chemicals or new chemical use notices were under review, the EPA said in response to emailed questions from Bloomberg BNA.

Historically, EPA has tended to have about 300 new chemicals under review at any given time, the agency said. With 481 new chemicals notices under review, that means the office has a “backlog” of 181 cases.

“EPA has revised and streamlined its process, brought in new staff to help in the reviews and is making progress in reducing the backlog of chemicals in the pipeline for review,” the agency said.

Cal Dooley, president of the American Chemistry Council, addressed the backlog issue in an April insights article he wrote for Bloomberg BNA.

At that time, the backlog of new chemicals awaiting the agency’s approval had doubled from 331 to 658 since passage of the amended law, Dooley wrote. Available information at the time had suggested the agency had approved only 33 substances since TSCA was amended, which he said was “a sharp decline for a program that has historically reviewed about 1,000 substances every year.” The chemistry council represents U.S. chemical manufacturers including 3M, Arkema, Inc., the BASF Corp., ExxonMobil Chemical Co., and LyondellBasell Industries Holdings B.V.


Auer, Hitchcock, Newton and Dimitrios Karakitsos, a partner with Holland & Knight LLP’s Washington, D.C., office, agreed the agency’s information shows it is making progress to speed its reviews of new chemicals.

“The folks at the EPA are righting the ship,” said Karakitsos, who previously served as counsel to the Republicans on the Senate Environment and Public Works Committee. In that role, he served as a principal drafter and negotiator of the amended chemicals law.

The progress to date shows EPA Administrator Scott Pruitt’s commitment to lead an agency that follows the law Congress wrote, Karakitsos said.

Democrats and Republicans supported the Lautenberg Act with the understanding from the EPA that the changes lawmakers were making to the agency’s new chemicals oversight would allow U.S. chemical manufacturers to continue innovating, he said.

“Maintaining robust innovation was a huge priority in both the House and the Senate,” Karakitsos said.

“New chemicals are generally greener, more environmentally friendly and less toxic,” he said. All sides have an interest in a predictable process that allows the products of innovation to get to market.

Trend Encouraging Older Chemicals?

Auer said his experience at the EPA, which included directing the agency’s chemicals office, Office of Pollution Prevention and Toxics, taught him that chemistry is improved slowly over time.

“Most chemical developments occur through relatively small tweaks,” he said. Companies adjust some portion of a molecule, he said. That adjustment produces significant improvements in performance while reducing toxicity and saving money through means such as reduced energy use, waste generated or other environmental benefits, Auer said.

Hence, Auer and Newton said they were concerned by the agency’s increased regulation of new chemicals.

“It’s ironic there’s so much focus on restricting new chemicals,” because the problems, Newton said.

A consequence of increased regulation of new chemicals, Auer said, is that the companies that purchase chemicals to make products continue to use existing chemicals.

To contact the reporter on this story: Pat Rizzuto in Washington at prizzuto@bna.com

To contact the editor responsible for this story: Paul Connolly at PConnolly@bna.com

For More Information

Information about the EPA's new chemical reviews is available at http://src.bna.com/oWm and http://src.bna.com/oWn.

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