New-Chemical Makers Face More Consent Orders, EPA Says

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By Pat Rizzuto

Sept. 19 — The Environmental Protection Agency will be asking manufacturers of new chemicals to sign consent orders that delineate the manufacture and use of their substances more frequently than it did before the Toxic Substances Control Act was amended, a senior agency official told Bloomberg BNA Sept. 19.

If the production method and uses anticipated by a manufacturer of a new chemical would not be likely to pose an unreasonable risk—but other manufacturing methods or uses of the chemical might—the agency now is requiring the original manufacturer to legally bind itself to the production, worker safety, environmental release restrictions and other conditions it described in its premanufacture notice (PMN), Wendy Cleland-Hamnett, director of the EPA’s Office of Pollution Prevention and Toxics, told Bloomberg BNA. Chemical manufacturers that want to make a new chemical—meaning one that has not previously been made in or imported into the United States—must submit premanufacture notices at least 90 days before they intend to make the new molecule.

The need for notice submitters to sign more consent orders is spurred by a requirement in the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182), which amended TSCA as of June 22, Cleland-Hamnett said.

Prior to the Lautenberg Act becoming law, the agency’s new chemicals office developed numerous toxicity and environmental fate prediction models to help staff anticipate potential health and environmental concerns and exposures, but now the law mandates those considerations.

Under the Lautenberg Act, however, as the EPA reviews premanufacture notices it is required to consider the “intended, known, or reasonably foreseeable circumstances under which a chemical is manufactured, processed, distributed, disposed of, or used.”

A consent order binds the original manufacturer of a new chemical to making the chemical as it said it would in its premanufacture notice, Cleland-Hamnett said. The agency can then issue a significant new use rule to restrict any other new chemicals manufacture to the same manufacturing and use conditions, she said.

90 Days Since Amended Toxics Act Became Law

Bloomberg BNA requested the interview on Sept. 19 because that day marked 90 days after the Lautenberg Act went into effect. That means the agency was required to take some type of action on the more than 300 premanufacture notices (PMNs) that it was reviewing when the Lautenberg Act became law. The actions available to the EPA include allowing a new chemical to enter commerce, asking the company that wants to make the new chemical for additional toxicity or exposure data, or asking the company to voluntarily suspend the 90-day clock while it and the agency address questions. Under both the original and amended TSCA, the EPA has 90 days to review premanufacture notices.

The agency was unable to provide Bloomberg BNA by Sept. 19 specific numbers to document how many data requests, decisions or other actions it had made regarding the 334 notices that Cleland-Hamnett said were under review on June 22.

The EPA “reset” the 90-day clock on June 22 for each of the 334 notices that was under review the day the Lautenberg Act became law. The agency took that action for two reasons.

First, the agency needed to review the notices using the new “reasonably foreseeable conditions of use” and other criteria focused on preventing unreasonable risks to potentially exposed or susceptible populations.

Second, the agency needed to comply with a new procedure the law requires. Under the original TSCA, if the EPA took no action as it reviewed a new chemical, the substance could enter the market after 90 days.

The Lautenberg Act changes that by requiring the EPA to make a specific, or “affirmative,” finding about each new chemical it reviews. The agency may conclude a new chemical “is not likely to present an unreasonable risk” or, if the chemical does pose an unreasonable risk or might, the law requires the agency to restrict the chemical’s manufacture or use in some way to prevent that potential health or ecological harm.

Agency Boosts Staff

Cleland-Hamnett said, after the initial few weeks, the Lautenberg Act did not significantly delay the agency’s new chemical reviews. Initially, her office needed to work with the agency’s Office of General Counsel to understand how to implement the new law and how to document its conclusion in an “affirmative finding,” she said.

The backlog also built up because, as of June 22, the agency had to re-review PMNs that it had received—but not finished analyzing—before the Lautenberg Act became law while it continued to receive and review new premanufacture notices, Cleland-Hamnett said.

To handle that temporary backlog, the agency recruited some staff working in other parts of the agency to the chemicals office on 4-month details. Staff within OPPT’s Risk Assessment Division, who already focus on new and existing chemicals, were asked to focus specifically on new chemicals, Cleland-Hamnett said.

The agency also increased the frequency of new chemical review meetings it holds where multiple staff discuss issues about chemicals under review, she said.

Nevertheless, according to trade associations and law offices Bloomberg BNA spoke with on Sept. 19, the agency has not reached final decisions on many of the premanufacture notices that it has been reviewing.

That’s not unusual, Cleland-Hamnett said. The agency often asks chemical manufacturers to voluntarily stop the 90-day clock to address questions that arise during new chemical reviews, and chemical manufacturers typically agree.

When the Lautenberg Act went into effect, companies that wanted to make more than 200 of the 334 new chemicals under review already had voluntarily agreed to stop the 90-day clock, she said.

The agency did not have to immediately ask these manufacturers to keep the clock suspended, since they already had done so, she said. But now that the first 90-day review period is complete, the agency is contacting the manufacturers and making that request, she said.

More Information Helps Agency’s Reviews

Chemical manufacturers could reduce the time the agency spends reviewing new chemicals if they provided more information when they submit premanufacture notices, Cleland-Hamnett said.

Neither original TSCA nor the Lautenberg Act imposes any minimum data set on PMN submitters. Companies often have information that would be useful to receive, however, she said.

Many of the agency’s decisions about new chemicals, for example, are based on existing analogous substances, she said. If a company that submits a notice thinks there is an analogous chemical, it would be useful to know that and the rationale for that at the time the notice is submitted, Cleland-Hamnett said.

Otherwise, the question of which chemical provides a good surrogate for the new chemical becomes an issue the agency and submitter of the request must address in the midst of the review, she said.

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

To contact the editor responsible for this story: Larry Pearl at lpearl@bna.com

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