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By Pat Rizzuto
July 12 — The criteria the Environmental Protection Agency is using to decide whether more than 300 new chemicals can enter commerce changed June 22 when the primary U.S. chemicals law was amended, according to information the agency provided Bloomberg BNA July 11.
The agency didn't reply July 11 or 12 to questions about whether it has made decisions since June 22 about whether some of those new chemicals could enter U.S. commerce.
Nor did the agency say when it would make or release those decisions.
Lynn Bergeson, managing partner of Bergeson & Campbell PC, told Bloomberg BNA July 11 the number of new chemicals affected by the EPA's implementation of the newly amended Toxic Substances Control Act isn't large.
For an individual company, however, every day that delays its ability to bring a new chemical or a new use of a chemical to market is huge, Bergeson said. “Every day counts.”
Both the original and amended TSCA provide the EPA 90 days to review new chemicals.
Chemical manufacturers submit a premanufacture notice (PMN), which triggers the 90-day timeline.
The 90-day clock also applies to two other types of new chemical requests—significant new use notices (SNUNs), through which a company seeks to make or use a chemical in a way the EPA has designated to be new; and microbial commercial activity notices (MCANs ), which chemical manufacturers must submit before they commercialize certain microorganisms that can help produce chemicals
The EPA had about 325 new chemical notices under review when President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act into law June 22, the agency said.
When the Lautenberg Act became law, the agency “reset” the clock, meaning the 90-day review period officially restarted.
The EPA said it needed the restart to ensure it reviewed new chemicals using the criteria the Lautenberg Act provides.
The agency also must—for the first time—make a definitive conclusion about whether a new chemical may pose an unreasonable risk before the chemical can be made in or imported into the U.S. Prior to Lautenberg, if EPA took no action during its 90-day review, the new chemical could enter into commerce.
Despite the 90-day reset, the agency said it would strive to review the new chemicals affected by amendments by the deadline that was in effect prior to the amendments.
Under the Lautenberg Act, the EPA must consider whether the manufacturing, processing and use of a new chemical would pose an unreasonable risk to potentially susceptible populations, including infants, pregnant women, workers and the elderly, Sara Beth Watson, an attorney with Steptoe & Johnson LLP said during a July 12 webinar the law firm held.
After evaluating the toxicity of and anticipated exposure to the new chemical, the Lautenberg Act requires the EPA to make one of several findings.
The EPA may conclude the chemical isn't likely to present an unreasonable risk and can be made in or imported into the U.S.
The agency may decide it needs more information and order the submission of that information.
The EPA may conclude the new chemical would present an unreasonable risk, but control that risk through means such as limiting the chemicals' release to water or requiring workers to wear protective gloves if they could touch the new chemical.
The EPA also could conclude the new chemical presented an unreasonable risk and bar it from commerce.
The agency is likely to ask manufacturers that would like to make or import new chemicals to provide it more data to assess risks and make the required decisions than the agency has done in the past, Watson said.
Jim Jones, EPA assistant administrator for chemical safety and pollution prevention, said June 28 he expects the EPA to use the Lautenberg Act's criteria to reach one of the new chemical decisions the law provides within a week to 10 days. Jones spoke at an American Bar Association forum about the TSCA amendments.
During that same forum, Bergeson said some of the clients her law firm represents had nearly reached the end of the agency's original 90-day review period just prior to the Lautenberg Act becoming law.
As of July 12, none of those clients had been told whether it can make or import those new chemicals, she told Bloomberg BNA.
When the EPA reaches whatever conclusions it will concerning the new chemicals it is reviewing, the agency should promptly advise the submitter with a letter or other documentation, she said.
The EPA told Bloomberg BNA it will send letters to companies when a “not likely to present an unreasonable risk” determination is made, so that the submitter of the PMN is formally notified of the EPA’s determination.
In addition to these letters, the EPA also intends to post its determinations online and publish them in the Federal Register regularly, the agency said.
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