TSCA 8(e) requirements are real.
Any person who manufactures, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information.
EPA issued a fine to Elementis for failure to turn in an epidemiology study on chromium workplace exposures. The company argued EPA already knew the information in the study. They also argued that there is a 5 year statute of limitations for 8(e). Elementis lost BIG.
The Administrative Law Judge decision agreed with EPA that there is no statute of limitation for failure to submit an 8(e) notice. With 8(e) violations pulling the highest fine ($37, 500) on a daily basis, the numbers rack up quickly.
The judge also agreed with EPA that the study results were not known to the Administrator and contained "substantial risk" information. Nor was it considered "corroborative" which now means:
"...the test for exemption is not whether the findings or interpretations of data “corroborate” merely what another study has found or what a particular research team ultimately concludes, but is instead whether the SRI [substantial risk information], which is much broader, “corroborates” what is already “well-established.” [the core decision]
(Meaning "corroborative" is identical and probably so repetitive of published studies there's no reason you would even do it?)
Elementis got no mitigation on the fine because is was discovered by EPA as a result of a subpoena and not self-reported.
Presumably Elementis will appeal the decision, given the size of the fine. Stay tuned.
EHS Strategies, Inc. can help advise you on reporting under section 8(e).
- Tags:
- penalty
- substantial risk
- TSCA