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Assessing and Managing Chemicals under TSCA

List of Manufacturer-Requested Risk Evaluations under TSCA Section 6

News and Updates

EPA is extending the public comment period for the Manufacturer-Requested Risk Evaluation for OTNE. Learn more.

TSCA allows chemical manufacturers to request an EPA-conducted risk evaluation of the chemical under 40 CFR 702.37. A manufacturer may request that EPA conduct a risk evaluation for conditions of use of interest to the manufacturer. Within 60 business days of the receipt of a facially complete request, EPA is required to submit the request for publication in the Federal Register, open a docket for the request, and provide a public comment period of no less than 45 calendar days. After the comment period closes the Agency has 60 calendar days to either grant or deny the request.

Learn more about manufacturer-requested risk evaluations.

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Diisodecyl Phthalate (DIDP)

On May 24, 2019, EPA received a request from ExxonMobil Chemical Company, through the American Chemistry Council’s High Phthalates Panel, to conduct a risk evaluation for diisodecyl phthalate (DIDP). On August 19, 2019, EPA opened a 45-day public comment period to gather information relevant to the requested risk evaluation. EPA reviewed the request (along with additional information received during the public comment period) and assessed whether the circumstances identified in the request constitute conditions of use under 40 CFR 702.33, and whether those conditions of use warrant inclusion within the scope of a risk evaluation for DIDP. EPA determined that the request meets the applicable regulatory criteria and requirements. The Agency granted the request on December 2, 2019.

EPA published for public comment the draft scope on November 27, 2020. EPA will accept comments in docket EPA-HQ-OPPT-2018-0435 for 45 days following publication of the Federal Register Notice announcing the availability of the draft scope before finalizing the scope of the risk evaluation for DIDP.

DIDP belongs to a family of chemicals called phthalates and is commonly used as a plasticizer in the production of plastic and plastic coating to increase flexibility. The request included two Chemical Abstract Registry Service Numbers (CASRNs), one of which  was identified on the 2014 Update to the TSCA Work Plan (CASRN 26761-40-0).

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Diisononyl Phthalate (DINP)

On May 24, 2019, EPA received a request from the ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex, through the American Chemistry Council’s High Phthalates Panel, to conduct a risk evaluation for diisononyl phthalate (DINP).  On August 19, 2019, EPA opened a 45-day public comment period to gather information relevant to the requested risk evaluation. EPA reviewed the request (along with additional information received during the public comment period) and assessed whether the circumstances identified in the request constitute conditions of use under 40 CFR 702.33, and whether those conditions of use warrant inclusion within the scope of a risk evaluation for DINP. EPA determined that the request meets the applicable regulatory criteria and requirements. The Agency granted the request on December 2, 2019.

EPA published for public comment the draft scope on November 27, 2020. EPA will accept comments in docket EPA-HQ-OPPT-2018-0436 for 45 days following publication of the Federal Register Notice announcing the availability of the draft scope before finalizing the scope of the risk evaluation for DINP.

DINP belongs to a family of chemicals called phthalates and is commonly used as a plasticizer in the production of plastic and plastic coating to increase flexibility. The request included two CASRNs, one of which  was identified on the 2014 Update to the TSCA Work Plan (CASRN 28553-12-0).

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Octamethylcyclotetra- siloxane (D4) 

On March 19, 2020, EPA received a request from Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center (SEHSC), to conduct a risk evaluation for octamethylcyclotetra- siloxane (D4). On June 17, 2020, EPA opened a 45-day public comment period to gather information relevant to the requested risk evaluation. The Agency granted the request on October 6, 2020.

D4 is used to make other silicone chemicals and as an ingredient in some personal care products. D4 was identified in the 2014 Update to the TSCA Work Plan. Additionally, in 2014 EPA issued an enforceable consent agreement for D4 requiring environmental testing data to help the agency better understand the potential effects of this chemical in the environment.

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Octahydro-tetramethyl-naphthalenyl-ethanone Chemical Category (OTNE)  

EPA is requesting public comments on a request from from International Flavors and Fragrances, Inc. (IFF), Privi Organics USA Corporation (Privi), and DRT America, Inc. (DRT), through the OTNE Consortium, to conduct a risk evaluation for four chemical substances as a category, the octahydro-tetramethyl-naphthalenyl-ethanone (OTNE) chemical category. The request was received on November 20, 2020, and EPA found the request to be facially complete on December 8, 2020.

EPA is accepting public comments on the manufacturer request for risk evaluation of OTNE in docket EPA-HQ-OPPT-2020-0738. The current comment period was set to close on April 5, 2021 and EPA is extending the comment to period for an additional 30 days. The comment period will now close on May 5, 2021. The docket contains the manufacturer request for EPA to conduct a risk evaluation, EPA’s proposed additional conditions of use, and the basis for including those proposed additions. During the public comment period, EPA is encouraging public comment on the manufacturer request, as well as the additional conditions of use EPA is proposing to include in the risk evaluation. 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).

OTNE is used as a fragrance ingredient. The four chemical substances in this chemical category (CASRNs 54464-59-4, 54464-57-2, 68155-67-9, and 68155-66-8) were identified in the 2014 Update to the TSCA Work Plan

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