EPA Grants First Two Manufacturer Requests for Risk Evaluation under the Toxic Substances Control Act

For Release: December 2, 2019

EPA granted the first two manufacturer requests for risk evaluations for DIDP and DINP. If the requests are not withdrawn within 30 days, both DIDP and DINP will enter the risk evaluation process. Manufacturer-requested risk evaluations are conducted in the same manner as other risk evaluations conducted under section 6(b)(4)(A) of the Toxic Substances Control Act (TSCA).

EPA received the two manufacturer requests to conduct risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP) from the American Chemistry Council’s High Phthalates Panel in May 2019. Both DIDP and DINP belong to a family of chemicals called phthalates and are commonly used as plasticizers in the production of plastic and plastic coating to increase flexibility. They were identified in the 2014 Update to the TSCA Work Plan.

In August 2019, EPA asked for public comment on the two manufacturer requests and based on the comments received and EPA’s review of the requests, EPA concluded that the Agency had all information needed to conduct both risk evaluations. EPA has granted both requests and intends to initiate the risk evaluations shortly.

Background

Under TSCA section 6(b)(4), 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 a potentially exposed or susceptible subpopulations, under the conditions of use. The final rule also allows manufacturers of a chemical to request an EPA-conducted risk evaluation on the chemical for conditions of use of interest to the manufacturer.

EPA found the requests for DIDP and DINP facially complete in accordance with 40 CFR 702.37(e)(1) on June 13, 2019. A 45-day public comment period was opened for each request on August 19, 2019, which allowed the public to submit comments relevant to the requested risk evaluations. EPA reviewed the requests and determined that each request met the applicable regulatory criteria and requirements laid out in 40 CFR 702.37(e)(6)(ii). Specifically, EPA assessed and confirmed that each circumstance identified in the request constitutes a condition of use under 40 CFR 702.33, and each condition of use warrants inclusion within the scope of the risk evaluation for both DIDP and DINP. Lastly, EPA has confirmed that all other criteria and requirements under 40 CFR 702.37 have been met.