EPA Receives Manufacturer Request for Risk Evaluation of Chemical Category under TSCA Section 6
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on December 8, 2020, that it received a complete manufacturer request to conduct a risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers. International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C® Consortia Management, L.L.C. (BCCM). According to EPA, OTNE is used as a fragrance ingredient, and the four chemicals were identified in the 2014 Update to the Toxic Substances Control Act (TSCA) Work Plan.
EPA states that it “worked diligently with the manufacturers to ensure this request was high-quality, complete, and met all the necessary legal requirements.” Two chemicals in the category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under TSCA, and EPA describes this request for a manufacturer-requested risk evaluation as “part of EPA’s overall efforts to address PBTs.”
Within 15 business days of receiving a facially complete request, EPA must notify the public of receipt of the request under 40 C.F.R. Section 702.37(e)(2). Within 60 business days of receipt of a facially complete request, EPA will submit for publication the receipt of the request in the Federal Register, open a public docket for the request, and provide no less than 45 calendar days for public comment. The docket will contain the manufacturer request, EPA’s proposed additions of conditions of use, and the basis for those proposed additions. During the public comment period, the public may comment on the request, as well as the additional conditions of use EPA proposes for inclusion. After the comment period closes, EPA has up to 60 days to either grant or deny the request to conduct a risk evaluation under 40 C.F.R. Section 702.37(e)(6).