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By Pat Rizzuto
July 22 — The Environmental Protection Agency issued its first regulatory decisions July 22 for new chemicals using the criteria of the amended Toxic Substances Control Act.
The EPA concluded chemical manufacturers may make or import four new chemicals, because none is “likely to present an unreasonable risk.”
The four chemicals, identified by generic names, will be used in lubricants, added to plastics and used to make other chemicals including polymers.
The EPA's decisions and the information it released about them are part of the changes brought about by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. Law No. 114–182), which amended TSCA when it became law on June 22.
Prior to Lautenberg, a new chemical—one that had never been made or sold in the U.S. before—could simply enter U.S. commerce after 90 days unless the EPA raised objections.
Information about the chemical, the rationale that prompted the agency to raise objections or not, and details on controls it may or may not have requested a manufacturer to take were, typically, a “black box,” Richard Denison, lead senior scientist with the Environmental Defense Fund, told Bloomberg BNA July 22.
Now the agency must review all new chemicals and make a specific decision about whether they would pose an unreasonable risk.
The agency may, as it did with these four chemicals, decide a chemical is not likely to present an unreasonable risk. It also could conclude the chemical may pose an unreasonable risk warranting some type of restrictions or controls. The EPA also could conclude it has insufficient data to make a conclusion and order the manufacturer to submit additional information on toxicity or exposure.
The reasoning behind the agency's decision must be public under Lautenberg.
A new EPA webpage contains its new chemical decisions, called “determinations,” and provides links to documents that provide more detail for each chemical reviewed.
The information EPA posted contains an unprecedented amount of transparency about the reasons the agency reached its decisions and the methods it used to make them, Denison said.
Denison said he also liked that the agency in its decision documents described not only the manufacturer's intended use of a new chemical but also known or reasonably foreseeable applications.
Denison and Dan Newton, a senior manager with the Society of Chemical Manufacturers and Affiliates, said it is early to know how future decisions will play out.
Chemical manufacturers must submit premanufacture notices at least 90 days before they would like to make or import a new chemical. The decisions EPA announced addressed four of 58 of the notices it received from April 1 through April 29, according to information the agency published in the Federal Register June 2 (81 Fed. Reg. 35,351).
Nevertheless, Newton said, “this is certainly a good start.”
“EPA selected low-hanging fruit; the chemicals are low hazard,” Newton told Bloomberg BNA. “We are still in the beginning of a new process, so things can change.”
Newton commended the EPA for the speed at which it arrived at those four decisions.
The agency announced its determinations soon after the 90-day new chemicals review period established under TSCA, he said. That is noteworthy, because the agency announced a temporary hold on all new chemical decisions for PMNs that were pending before it on June 22, when the Lautenberg Act became law.
It is unclear how swiftly the agency will act with the other pending new chemicals it is reviewing, Newton said.
Lynn Bergeson, managing partner of Bergeson & Campbell PC, told Bloomberg BNA: “On the whole, the process seems to be efficient, but stakeholders will need to monitor the website.”
Newton urged new chemical submitters to pay close attention and be ready to share their experiences with their respective trade associations and the agency.
“We need to keep lines of communication open with the agency to help make the transition seamless,” he said.
Denison said he would like the EPA to post more information as it releases additional new chemical assessments and determination documents.
The Lautenberg Act requires the EPA to explicitly review the risks chemicals pose to potentially exposed or susceptible subpopulations.
The agency gave limited and inadequate considerations of such populations in these first four decisions, he said.
In the future it also would be useful for the EPA to clarify whether the chemical it analyzed would work well with the particular toxicity, exposure or other models it used to predict the chemical's characteristics, Denison said.
Like all models, the agency's have limitations, and it would be useful to know the extent to which a model would be expected to accurately predict how a new chemical would behave in the environment, an organism, or people.
Other documents the agency develops also should be released, Denison said.
The agency routinely analyzes the compound structure and other available information for a new chemical and prepares internal reports examining issues such as how the substance may move through the environment and how it could expose plants, wildlife or people and potential health effects.
Those structure activity, engineering and exposure reports are seldom released to the public and when they are they are heavily redacted, Denison said.
The information those reports contain would be helpful even if it must be redacted, he said.
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EPA's new chemical decisions are available at http://bit.ly/2alZVoK.
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