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EPA Receives Manufacturer Requests for Risk Evaluations Under TSCA Section 6

For Release: June 14, 2019

On May 24, 2019, EPA received manufacturer requests for EPA to conduct risk evaluations of diisodecyl phthalate (DIDP) from ExxonMobil Chemical Company and diisononyl phthalate (DINP) from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex, both through the American Chemistry Council’s High Phthalates Panel. Both DIDP and DINP belong to a family of chemicals called phthalates, which are commonly used as plasticizers in the production of plastic and plastic coatings to increase flexibility. They were identified in the 2014 Update to the TSCA Work Plan.

Under section 6(b)(4) of the Toxic Substances Control Act, 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 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 questions concerning DIDP (EPA-HQ-OPPT-2018-0435), please contact Eva Cappuccilli at cappuccilli.eva@epa.gov. For questions concerning DINP (EPA-HQ-OPPT-2018-0436), please contact Darlene Leonard at leonard.darlene@epa.gov.

For more information on manufacturer requests: https://19january2021snapshot.epa.gov/assessing-and-managing-chemicals-under-tsca/list-manufacturer-requested-risk-evaluations-under-tsca