EPA Will Hold Public Comment Period for Manufacturer-Requested Risk Evaluation for OTNE
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on February 18, 2021, that it is opening a public comment period for a manufacturer-requested risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers. EPA notes that two chemicals in the OTNE category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under TSCA, “meaning they are toxic, can remain in the environment for long periods of time, and can build up or accumulate in the body.” Upon publication of the Federal Register notice announcing the public comment period, EPA will accept public comments on the request for 45 days. EPA states that it “welcomes all public comments,” particularly on the following:
- Any information not included in the manufacturer request that commenters believe EPA would need to conduct a risk evaluation;
- Additional conditions of use EPA is proposing to include in the risk evaluation; and
- Information on conditions of use not included in the manufacturer request or in the additional conditions of use EPA proposes to include in the risk evaluation, specifically the inclusion of any additional conditions of use and potentially exposed or susceptible subpopulations. EPA states that it “is in the process of broadly re-examining how it intends to implement these and other provisions of amended TSCA including determining how new executive orders will be addressed. This process would benefit greatly from stakeholder feedback.”
After the comment period closes, EPA will review the comments and either grant or deny the request to conduct a risk evaluation within 60 days. If EPA grants the request, the manufacturers would be responsible for half the cost of the risk evaluation. 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).