Overview
On January 16, 2024, Enhesa (formerly Chemical Watch) quoted Michael Boucher in an article entitled, “US EPA prepares to call in more data on TSCA prioritization candidates.” The article discusses US EPA’s plans to issue a TSCA § 8(d) rule and a second TSCA § 8(c) call-in to collect unpublished health and safety studies and recorded allegations of significant adverse reactions, respectively, for 15 chemical substances that are candidates for designation by US EPA as a high priority for risk evaluation under TSCA § 6(b).
Regarding US EPA’s calling in companies’ records of allegations of significant adverse reactions under TSCA § 8(c), Boucher said that while companies are, in theory, well aware of section 8(c), a longstanding TSCA obligation, and should be ready to produce any requested 8(c) records to US EPA, in practice, there is uneven awareness of section 8(c) in the chemical industry, making the success of US EPA’s call-ins dependent on industry’s awareness of section 8(c), its maintenance of required records, and it compliance with the call-ins.
Regarding whether an 8(c)-recordable allegation of a significant adverse reaction also could be “substantial risk information” that is separately reportable to US EPA under TSCA § 8(e), Boucher said that there is a reasonably clear distinction between 8(c) allegations and 8(e) substantial risk information, and that a pattern of 8(c)-recordable allegations would be reportable to US EPA under section 8(e), if ever, only when the allegations, taken together, constituted evidence of substantial risk.
Read the article at Enhesa (subscription may be required).
