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By Lynn L. Bergeson and Carla N. Hutton
 
On August 31, 2021, the U.S. Environmental Protection Agency (EPA) released the final scope documents for the Toxic Substances Control Act (TSCA) risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP). 86 Fed. Reg. 48695; 86 Fed. Reg. 48693. In its August 31, 2021, press release, EPA notes that 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.”
 
According to EPA, the final scope documents reflect the policy changes on risk evaluations announced in June 2021. This includes plans to consider exposure pathways that may be regulated outside of TSCA, like air and water, and potential for exposures to fenceline communities (i.e., communities near industrial facilities). EPA states that “[a]ssumptions that personal protective equipment (PPE) in occupational settings will always be properly utilized will not be used as the basis for the risk determination. Use of PPE, and other ways industry protects its workers, will be assessed during the risk evaluation and considered as potential ways to address unreasonable risks during the risk management process.” More information on the policy changes is available in our July 1, 2021, memorandum.
 
The final scope documents explain EPA’s plan for the risk evaluations, including the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA will consider. The documents also include a description of the reasonably available information and the best available science approaches that EPA will use; a conceptual model that outlines the potential hazards and exposures throughout the life cycle of the chemical; an analysis plan to identify the approaches and methods EPA will use to assess health and environmental risks; and a plan for peer review. More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 16, 2019, that it is opening a public comment period for manufacturer requests for the risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), two chemicals used in plastic production.  EPA notes that the manufacturer-requested risk evaluations “are among the first such evaluations of this kind to be requested” under the Toxic Substances Control Act (TSCA).  EPA is also taking public comments on additional conditions of use it identified to include in the risk evaluations.  Upon publication of the Federal Register notices, comments may be submitted to Docket ID EPA-HQ-OPPT-2018-0435 for DIDP and Docket ID EPA-HQ-OPPT-2018-0436 for DINP for 45 days.  EPA encourages comments on any information not included in the manufacturer requests that commenters believe would be needed to conduct a risk evaluation.  EPA also welcomes any other information relevant to the proposed determinations of the conditions of use, including information on other conditions of use of the chemicals than those included in the manufacturer requests or in EPA’s proposed determinations.  After the comment period closes, EPA will review the comments and within 60 days either grant or deny the requests to conduct risk evaluations.  If these requests are granted, the manufacturers would be responsible for half the cost of the risk evaluations.  More information is available in our August 19, 2019, memorandum, "EPA Begins Comment Period on Manufacturer Requests for Risk Evaluation of DIDP and DINP, and Identifies Additional Conditions of Use."


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On June 14, 2019, the U.S. Environmental Protection Agency (EPA) announced that 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.  EPA states that both DIDP and DINP belong to a family of chemicals commonly referred to as phthalates, which are used as plasticizers in the production of plastic and plastic coatings to increase flexibility and were identified in the 2014 Update to the Toxic Substances Control Act (TSCA) Work Plan.

Within 15 business days of receiving a facially complete request (i.e., submission appears to be consistent with rule requirements), EPA states that it must notify the public of receipt of this request under 40 C.F.R. Section 702.37(e)(2); and 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.  After the comment period closes, EPA has up to 60 days to either grant or deny the request to conduct a risk evaluation under 40 C.F.R. Section 702.37(e)(6).  More information on Manufacturer Requests is available on EPA’s website.