Court Vacates EPA Test Order, Citing Incomplete Evidence in Public Record
On August 28, 2024, the D.C. Circuit issued an order in Vinyl Institute v. EPA, a case challenging a Toxic Substances Control Act (TSCA) test order issued in March 2022. The mandate signals that neither party intends to appeal the court’s July 5 ruling, which found EPA’s justification for the test order inadequate.
The test order, which required an avian reproduction study of 1,1,2-Trichloroethane, was vacated and remanded to EPA. However, the panel noted several places in which additional EPA materials would have satisfied TSCA’s “substantial evidence” standard if they were included in the public record, suggesting that EPA would not necessarily be required to perform additional analyses to justify future test orders as long as the analyses were included in the record.
For example, the court ruled that EPA’s “conclusory statements” in the public record on why vertebrate testing was necessary were inadequate, but also said that other documents showed that EPA considered new approach methodologies (as required by TSCA). However, the court ruled that these documents—although covered by EPA’s brief—were not part of the administrative record that was available to the public, and that therefore “they are not part of the record subject to our review.”
According to the decision, not all studies referenced in the statement of need accompanying the test order were explained or even identified. Nor did EPA publicly explain why those studies’ findings could not be used to fill the data gap, the court said.
“EPA should have explained why it could not extrapolate mammalian chronic exposure data to avian chronic exposure in its Statement of Need description of reasonably available information,” Judge Karen LeCraft Henderson wrote. “Identifying close but ultimately inapplicable studies and explaining, in the record, why it could not extrapolate other potentially relevant findings could constitute substantial evidence.”
However, the court upheld EPA’s decision to issue a test order rather than pursuing a rule or consent agreement, agreeing with EPA that timeliness in acquiring the data was sufficient justification. EPA initiated the risk evaluation for 1,1,2-Trichloroethane in December 2019 but has yet to issue a report on its findings.
Judge Henderson also agreed that EPA was not required to demonstrate that exposure may exist at potentially toxic levels before issuing a test order. That would “reverse[]…TSCA’s allocation of burdens,” the decision states.
Judge Henderson was joined in full by Judge Florence Pan and in part by Judge Justin Walker. A previous blog post on the case, written after the December 2023 oral argument, can be found here.