On August 31, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of the final scope documents for the manufacturer-requested risk evaluations (MRRE) of di-isodecyl phthalate (DIDP) and diisononyl phthalate (DINP). 86 Fed. Reg. 48695; 86 Fed. Reg. 48693. The scope documents include the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluations for DIDP and DINP. In its press release, EPA notes that the final scope documents reflect its 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. According to EPA, assumptions that personal protective equipment (PPE) in occupational settings will always be properly utilized will not be used as the basis for the risk determination. EPA states that it will assess use of PPE, and other ways industry protects its workers, during the risk evaluation and will consider these methods as potential ways to address unreasonable risks during the risk management process.

DIDP

According to the final scope of the risk evaluation for DIDP, EPA plans to evaluate manufacturing (including importing); processing; distribution in commerce; industrial, commercial, and consumer uses; and disposal of DIDP in the risk evaluation. DIDP is manufactured (including imported) in the United States. The final scope document states that DIDP is processed as a reactant; incorporated into a formulation, mixture, or reaction product; and incorporated into articles. The processing activities identified by EPA also include the repackaging and recycling of DIDP. DIDP is primarily used as a plasticizer in polyvinyl chloride (PVC) in consumer, commercial, and industrial applications. EPA identified industrial and commercial uses including use in automotive, fuel, agriculture, and outdoor use products. EPA also identified consumer uses such as use in furnishing, cleaning, and treatment/care products.

The final scope document states that some of these conditions of use were identified in the manufacturer request as circumstances on which EPA was requested to conduct a risk evaluation. EPA identified other conditions of use from information reported to EPA through Chemical Data Reporting (CDR), published literature, and consultation with stakeholders for both uses currently in production and uses whose production may have ceased. EPA presented the proposed additions of these EPA-identified conditions of use and the basis for these proposed additions, along with the manufacturer request, for a 45-day comment period in August 2019. EPA did not revise any conditions of use in the final scope document for DIDP based on public comments received.

DINP

According to the final scope of the risk evaluation for DINP, EPA plans to evaluate manufacturing (including importing); processing; distribution in commerce; industrial, commercial, and consumer uses; and disposal of DINP in the risk evaluation. DINP is manufactured (including imported) in the United States. The final scope document states that DINP is processed as a reactant; incorporated into a formulation, mixture, or reaction product; and incorporated into articles. The identified processing activities also include the repackaging and recycling of DINP. DINP is primarily used as a plasticizer in PVC in consumer, commercial, and industrial applications. EPA identified industrial and commercial uses, including use in automotive, fuel, agriculture, and outdoor use products and construction, paint, electrical, and metal products. EPA also identified consumer uses, such as use in furnishing, cleaning, and treatment/care products.

The final scope document states that some of these conditions of use were identified in the manufacturer request as circumstances on which EPA was requested to conduct a risk evaluation. EPA identified other conditions of use from information reported to EPA through CDR, published literature, and consultation with stakeholders for both uses currently in production and uses whose production may have ceased. EPA presented the proposed additions of these EPA-identified conditions of use and the basis for these proposed additions, along with the manufacturer request, for a 45-day comment period in August 2019. EPA revised the conditions of use in the final scope of the risk evaluation based on additional information received from public comments on the draft scope document for DINP.

Commentary

The final scope documents provide visibility into EPA’s updated approach to risk evaluations. EPA states that it will not assume that PPE is used in workplace settings and then further states that EPA will evaluate risk both with and without PPE. In previous risk evaluations, EPA evaluated risk both with and without PPE. It is less clear now, however, whether and how EPA’s new assumption will deviate from past practice. The difference may lie entirely in when EPA makes its determination about unreasonable risk. In the past (e.g., in some of the first ten final risk evaluations), EPA concluded that exposure to workers using PPE was not an unreasonable risk and issued an order stating that conclusion. EPA also concluded that unprotected exposures were an unreasonable risk, presumably requiring that EPA issue a regulation requiring use of PPE. With this new approach, EPA presumably will come to the same scientific conclusion but will wait to issue its formal conclusion that protected exposures are not an unreasonable risk when EPA issues the final risk management rule that requires PPE use. There are certainly some differences in the legal effect of these two courses of conduct, but the fundamental scientific conclusion is the same.

EPA includes use of DINP in toys despite the fact that DINP use in toys is prohibited by the Consumer Product Safety Commission (CPSC). The MRRE specifically requests that EPA include use in toys in the scope. In our view, this is justified because some toys manufactured prior to the CPSC ban that became effective on April 25, 2018, may still be available for purchase and/or use.

EPA was also silent in the final scope documents on how it intends to conduct fenceline analyses, in particular for marginalized communities for environmental justice purposes. In its June 30, 2021, press release, EPA stated that it is “developing a screening-level approach to conduct ambient air and surface water fenceline assessments.” EPA further stated that it planned to release the approaches and methods later this calendar year for public comment and peer review by the Scientific Advisory Committee on Chemicals. As of the date of posting the final scope documents, EPA has not, however, released further information on the screening-level approaches.