Get answers to your biomonitoring questions

Guidance for chemical manufacturers, processors, and distributors about Section 8(e) of the Toxic Substances control act was issued on September 14, by the U.S. Environmental Protection Agency (EPA). Chemical Processing's Regulatory Editor Lynn Bergeson discusses the new regulation.

By Lynn Bergeson, regulatory editor

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Section 8(e) requires manufacturers, who have obtained information that meets the statutory standard of “reasonably support[ing] the conclusion that such substance or mixture 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 www.epa.gov/oppt/tsca8e/pubs/qatsca.htm.

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.

TSCA reporting triggers

EPA’s thoughts on the submission of biomonitoring data that are believed to trigger TSCA Section 8(e) reporting are of particular relevance. Biomonitoring is the measurement of chemicals in blood, urine, and other human bodily fluids and tissue. In light of the abundance of such data, the applicability of TSCA reporting to them is a hot issue in TSCA circles. Vigorous and high-profile campaigns by nongovernmental organizations have taken the debate about the “harm” caused by chemical exposure to a new level. It is undeniable that the presence of chemicals in our bodies is compelling information. What is less clear is what this information means, what health and safety inferences, if any, can be drawn from the mere presence of detectable levels of chemicals in our bodies, and when such information must be reported to EPA under TSCA.

If new information on a chemical known to have serious toxic effects indicates a level of exposure previously unknown to EPA, it should be reported, EPA states in the Q&A. “[I]nformation that corroborates known exposure levels, such as those within the range of chemical blood levels and other biological monitoring data recorded in the NHANES (National Health and Nutrition Examination Survey) data base, is not reportable,” according to EPA. The Centers for Disease Control and Prevention’s “National Report on Human Exposure to Environmental Chemicals” derived from NHANES is available at http://www.cdc.gov/exposurereport.

While the Q&A isn’t explicit on when biomonitoring data are subject to TSCA Section 8(e), there is sufficient information provided to cause those subject to TSCA to carefully consider their legal obligations based on biomonitoring data. As always, careful review and legal counsel are essential elements of a winning TSCA compliance strategy.


Lynn Bergeson is the managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on chemical industry issues. Contact her at lbergeson@putman.net. The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.
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