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EPA Receives Manufacturer Request for Risk Evaluation Under TSCA Section 6

For Release: December 8, 2020

On November 20, 2020, EPA received a complete manufacturer request to conduct a risk evaluation for four chemical substances as a category, the octahydro-tetramethyl-naphthalenyl-ethanone chemical category (OTNE), from International Flavors and Fragrances, Inc. (IFF), Privi Organics USA Corporation (Privi), and DRT America, Inc. (DRT), through the OTNE Consortium. OTNE is used as a fragrance ingredient. The four chemicals were identified in the 2014 Update to the TSCA Work Plan.

EPA worked diligently with the manufacturers to ensure this request was high-quality, complete, and met all the necessary legal requirements. Two chemicals in the OTNE category are considered persistent, bioaccumulative and toxic (PBT) chemicals under the Toxic Substances Control Act (TSCA). This request for a manufacturer-requested risk evaluation is part of EPA’s overall efforts to address PBTs. In addition, the agency is planning to finalize rules for five other PBT chemicals identified for expedited action under TSCA this year.

Under section 6(b)(4) of TSCA, EPA issued a final rule that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to human health or the environment without consideration of costs or other non-risk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations, under the conditions of use. The final rule also establishes the process and criteria for manufacturers of a chemical to request an EPA-conducted risk evaluation on the chemical for conditions of use of interest to the manufacturer.

Within 15 business days of receiving a facially complete request (i.e., submission appears to be consistent with rule requirements), EPA must notify the public of receipt of this request under 40 CFR 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 is proposing for inclusion. After the comment period closes, the Agency has up to 60 days to either grant or deny the request to conduct a risk evaluation under 40 CFR 702.37(e)(6).

For more information on manufacturer requests: