Get answers to your biomonitoring questions

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Courtesy of Bergeson & Campbell, P.C.

Section 8(e) requires manufacturers, who have obtained information that meets the statutory standard of “reasonably support[ing] the conclusion that such substance orsmixture presents a substantial risk of injury to health or the environment,” to submit that information to EPA. The guidance is available in new Q&As at

Most enforced provisions
TSCA Section 8(e) reporting is among the most important reporting obligations for companies dealing with chemicals, and certainly one of the most enforced provisions of the Act. Over the many years of EPA’s TSCA enforcement, it has generated some heart-stopping penalties, in large part because EPA believes that such companieshave a clear duty to tell EPA when they become aware of information that reasonably supports the conclusion that the chemical presents a substantial risk of injury to health or the environment. While there are exceptions to the reporting rule, information must be immediately reported, meaning within 30 calendar days. EPA believes that promptly obtaining such information is essential to its ability to perform its duties under TSCA.

The new Q&As appear to be prompted, at least in part, by EPA’s enforcement actions against E.I du Pont de Nemours and Company (DuPont) and 3M involving alleged Section 8(e) violations. EPA announced a settlement, on December 14, 2005, involving $10.25 million in fines with DuPont resolving violations related to perfluorooctanoic acid (PFOA), where seven of the eight counts involved TSCA Section 8(e) violations. On April 25, EPA announced a $1.5 million settlement to resolve TSCA reporting violations that 3M voluntarily disclosed to EPA under the terms of a TSCA corporate-wide audit agreement. Of the 244 TSCA violations, five involved TSCA Section 8(e) studies/reports involving human data, and 229 involved TSCA Section 8(e) studies/reports involving other data.

The new Q&As provide guidance about several topics, including the definition of substantial risk, and questions regarding the submission of biomonitoring data. Also, the Q&As address when information is “known to the administrator,” including questions on reporting toxicity testing on plant effluents to monitor the quality of treated wastewater to comply with permit requirements under the Clean Water Act.

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