NEWS

By Pat Rizzuto

Aug. 15 — Three more new chemicals are unlikely to present an unreasonable risk and may enter the market, according to recent Environmental Protection Agency analyses.

Solazyme Inc., which uses algae to make industrial chemicals, is authorized by EPA to make two of the three chemicals. Its chemicals, both glycerides (P-16-0340 and P-16-0351), will be used as lubricants or lubricant ingredients or to make other chemicals.

The manufacturer of the third chemical (P-16-0392) justified to the EPA's satisfaction its need to keep its name confidential. That company can now modify vegetable oil to produce a chemical that can serve several functions, including being a fuel, fuel additive, lubricant or lubricant additive.

The EPA's recent decisions on the three chemicals mean that as of Aug. 15 it has affirmatively approved the entry of seven new chemicals onto the market using criteria established by the new Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended Toxic Substances Control Act.

Prior to Lautenberg, TSCA did not require the EPA to make any specific finding when it reviewed chemical manufacturers' premanufacture notices (PMNs), forms companies must submit before they are allowed to make or import a new chemical in the U.S.

Under Lautenberg

Subsequently, if the EPA took no action during the 90-day review period that TSCA provides for new chemicals, the new molecule simply could enter the market after the review period expired.

Now the EPA must review new chemicals using criteria—such as their risk to potentially exposed or susceptible populations—established by Lautenberg.

The amended law also requires the EPA to reach one of four decisions about each new chemical. The agency must find that either the chemical:

•  “presents an unreasonable risk,” and the EPA must issue an order authorized under Section 5(f) of TSCA to manage the risk;
•  information is insufficient to evaluate the chemical and the EPA must issue a Section 5(e) order to obtain more information;
•  “may present an unreasonable risk,” and the EPA must issue a 5(e) order to manage the risk; or
•  is “not likely to present an unreasonable risk” and can enter the market.

All seven of the new chemicals for which the agency has announced findings were deemed by the EPA to be “not likely to present an unreasonable risk.”

Hundreds of Decisions Pending

Chemical manufacturers have yet to see what concerns, lack of data or other factors would trigger any of the remaining three findings.

As of Aug. 15, the EPA was reviewing 416 premanufacture notices, an agency spokeswoman told Bloomberg BNA.

A total of 336 PMNs, including the seven for which the EPA has completed its analyses, were under review when President Obama signed the Lautenberg Act into law June 22, the EPA said.

The 90-day review period for those 336 PMNs was reset effective that day although the EPA repeatedly said it was trying to complete its analyses soon after they would have been finished had the law not been amended.

The EPA expects to soon publish a Federal Register notice identifying the premanufacture notices under review, the agency said.

Meanwhile, four Federal Register notices the EPA published since May 2 give some indication of the chemicals it is reviewing. Those notices show that the agency received at least 242 PMNs since March, including the seven it has since allowed to enter commerce.

According to these notices, the EPA received:

•  58 PMNs between March 1 and March 31 ( 81 Fed. Reg. 26,224);
•  58 PMNs between April 1 and April 29 ( 81 Fed. Reg. 35,351);
•  66 PMNs between May 2 and May 31 ( 81 Fed. Reg. 45,148); and
•  60 PMNs between June 1 and June 30 ( 81 Fed. Reg. 49,976).

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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