Manufacturer Request for Risk Evaluation of OTNE
On November 20, 2020, EPA received a manufacturer request for risk evaluation for the chemical substances in the octahydro-tetramethyl-naphthalenyl-ethanone chemical category (OTNE). These substances are used as fragrance ingredients. The three manufacturers, International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc., sent the request through the OTNE Consortium.
The risk evaluation request applies to four chemicals within OTNE. The Toxic Substances Control Act (TSCA) considers two of the chemicals to be persistent, bioaccumulative and toxic (PBT) chemicals. While completing the risk evaluation for the OTNE chemical, EPA is not allowed to consider costs or other non-risk factors (15 U.S.C. 2605(b)(4)(F)(iii)). The request for evaluation also includes possible conditions of use for EPA to identify.
EPA has until no later than June 5, 2021 to either grant or deny the request to conduct the risk evaluation for the OTNE chemicals. In order for EPA to grant the request, it must meet all of the requirements listed under 40 CFR 702.37(e)(6)(ii). These conditions are that the request constitutes conditions of use that warrant inclusion in a risk evaluation, EPA has all the necessary information to conduct the risk evaluation, and all the remaining criteria of 40 CFR 702.37 are met, such as manufacturers paying fees to support the risk evaluations.