Regulations

U.S. EPA approves three chemicals under new chemical law

U.S. EPA approves three chemicals under new chemical law

The U.S. Environmental Protection Agency (EPA) has determined that three new chemicals, which can be used as lubricants or lubricant additives, are “not likely to present an unreasonable risk” to human health or the environment and, therefore may, enter U.S. commerce, reports the Independent Lubricant Manufacturers Association (ILMA).

On June 22, 2016, U.S. President Barack Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which updates the Toxic Substances Control Act (TSCA). Mandated by section 5 of the amended TSCA, EPA’s New Chemicals program helps manage the potential risk to human health and the environment from chemicals new to the marketplace.

The EPA’s recent decision on these three new chemicals means that the EPA has approved seven new chemicals using criteria established by the new law. Except for one, which is a finishing agent for plastic additives, all the new chemicals that have been approved are either for use as lubricants or as lubricant additives.

PMN Case Number P-16-0392 is a modified vegetable oil that can produce a chemical that can be used as a fuel, a fuel additive, a lubricant or a lubricant additive. The manufacturer has justified to the EPA’s satisfaction the need to keep its name confidential.

PMN Case Numbers P-16-0351 and P-16-0340 are triglycerides produced by Solazyme Inc. (now called TerraVia).

Prior to the amendment, TSCA did not require the EPA to make any specific finding when it reviewed Premanufacture Notices (PMNs), which must be submitted before companies are allowed to make or import a new chemical in the U.S.

ILMA views the latest approval as “a positive development, as EPA must now make an affirmative determination about a new chemical.”

The new law 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.

The EPA said that 336 PMNs, including the seven for which the agency had completed its analyses, were under review when President Obama signed the TSCA reform legislation into law. The 90-day review period for those 336 PMNs was reset effective that day.

As of August 15, the EPA was reviewing 416 Premanufacture Notices, according to Bloomberg.

The EPA said it expects to soon publish a notice in the Federal Register identifying the Premanufacture Notices under review.

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