EPA Announces Public Comment Period for Manufacturer-Requested Risk Evaluation for Fragrance Ingredient

EPA is opening a public comment period for a manufacturer-requested risk evaluation of four chemical substances as a category, the octahydro-tetramethyl-naphthalenyl-ethanone chemical category (OTNE). OTNE is used as a fragrance ingredient. The manufacturer-requested risk evaluation of OTNE is the fourth evaluation of this kind to be requested under the Toxic Substances Control Act (TSCA).

Under TSCA, chemical manufacturers can request that EPA conduct a risk evaluation on a specific chemical. By giving manufacturers the opportunity to prioritize, identify, and request the evaluation of chemicals and conditions of use of interest to them, EPA is encouraging sensible and timely assessment of chemicals in the marketplace.

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. This request for a manufacturer-requested risk evaluation is part of EPA's overall efforts to address PBTs. In a related action, last December EPA released final rules that will reduce exposure to five PBT chemicals, further protecting public health and the environment. These rules went into effect on February 5, 2021.

Upon publication of the Federal Register notice, EPA will accept public comments on the request for 45 days in docket EPA-HQ-OPPT-2020-0738 on www.regulations.gov.

EPA welcomes all public comments on this request, particularly on the following:

• Any information not included in the manufacturer request that the commenters believe EPA would need to conduct a risk evaluation.
• Additional conditions of use the agency is proposing to include in the risk evaluation.
• Information on conditions of use not included in the manufacturer request or in the additional conditions of use EPA is proposing to include in the risk evaluation, specifically the inclusion of any additional conditions of use and potentially exposed or susceptible subpopulations.  The agency 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, the agency will review the comments and either grant or deny the request to conduct a risk evaluation within 60 days. If this request is granted, the manufacturers would be responsible for half the cost of the risk evaluation.

Learn more about the manufacturer-requested risk evaluation for OTNE.

Read more about manufacturer-requested risk evaluations on EPA's website.

Background

On November 20, 2020, EPA received a complete manufacturer request to conduct a risk evaluation for OTNE from International Flavors and Fragrances, Inc. (IFF), Privi Organics USA Corporation (Privi), and DRT America, Inc. (DRT), through the OTNE Consortium.

On December 8, 2020, EPA found this request to be facially complete. Under 40 CFR 702.37(e)(1), no later than 60 business days after receiving a request that EPA has determined to be facially complete, EPA is required to (1) submit for publication in the Federal Register the receipt of the request, (2) open a public docket for the request, and (3) provide no less than 45 calendar days for public comment.