C8 secrecy: GAO warns that EPA drops ball on monitoring

A new report from the U.S. Government Accountability Office, the investigative arm of Congress, give us more information about how little the government knows about what toxic chemicals are doing to human health. And interestingly, part of the report focuses on the U.S. Environmental Protection Agency’s lax enforcement efforts regarding DuPont Co.’s toxic chemical, C8.

In general, the report focuses on EPA’s failure to make good use of the growing body of “bio-monitoring data”– information about the levels of chemicals in human tissues or blood — that is out there. According to GAO investigators:

While EPA has initiated several research programs to make bio-monitoring more useful to its risk assessment process, it has not developed a comprehensive strategy for this research that takes into account its own research efforts and those of the multiple federal agencies and other organizations involved in bio-monitoring research.

…without a plan to coordinate its research efforts, EPA has no means to track progress or assess the resources needed specifically for bio-monitoring research. Furthermore, according to the National Academy of Sciences, the lack of a coordinated national research strategy has allowed widespread chemical exposures to go undetected, such as exposures to flame retardants.

The report continues:

EPA has not determined the extent of its authority to obtain bio-monitoring data under [the Toxic Substances Control Act], and this authority is untested and may be limited. The TSCA provision that authorizes EPA to require companies to develop data focuses on the health and environmental effects of chemicals. Since bio-monitoring data alone may not demonstrate the effects of a chemical, EPA may face difficulty in using this authority to obtain bio-monitoring data.

This is where C8 — and secrecy — come in …

GAO cites EPA’s enforcement case against DuPont over C8 (also known as PFOA) as an example where the lack of a clear policy and  questions about legal authority hampered the agency:

Until 2000, DuPont used the chemical PFOA  to make Teflon at a plant in West Virginia. In 1981, DuPont took blood samples of several female workers and two babies born to those workers. The levels of PFOA in the blood from the babies showed a measurable amount of PFOA crossed the placental barrier. 

DuPont moved its  female employees away from work in areas of the plant where PFOA was used. However, after conducting additional animal testing, DuPont concluded that the exposure levels associated with workers posed no reproductive risks and moved the women back into these areas. DuPont did not report the human blood sampling results to EPA, even when EPA requested all toxicology data associated with PFOA. DuPont also did not report to EPA the results of blood testing of 12 people living near the plant, 11 of whom had never worked in the plant and had elevated levels of PFOA in their blood. EPA initially received the 1981 blood sampling information from counsel for a class action lawsuit by citizens living near the West Virginia facility.

DuPont argued that none of the blood sampling information was reportable under TSCA because the mere presence of PFOA in workers’ and community members’ blood did not itself support the conclusion that exposure to PFOA posed any health risks.

EPA subsequently filed two actions against DuPont for violating section
8(e) of TSCA by failing to report the bio-monitoring data, among other
claims. In December 2005, EPA and DuPont settled both of these actions.
DuPont did not admit that it should have reported the bio-monitoring data,
but it agreed to a settlement totaling $16.5 million. Furthermore, EPA used
the bio-monitoring data it received in a subsequent risk assessment, which
was reviewed by the Science Advisory Board, together with other
information that was available at that time. Upon review, the board
suggested that the PFOA cancer data are consistent with the category of
“likely to be carcinogenic to humans” described in EPA Guidelines for
Carcinogen Risk Assessment.

As a result of this finding and other concerns associated with PFOA and PFOA-related chemicals, DuPont finally agreed to phase out the use of PFOA by 2015, in tandem with seven other companies. Thus, while EPA ultimately succeeded in using TSCA to remove PFOA from the market, it encountered great difficulty in doing so—that is, even when bio-monitoring data, coupled with animal toxicity studies, arguably helped point out serious risks to human health associated with PFOA, DuPont’s position was that section 8(e) did not
require it to submit the bio-monitoring data it had collected on PFOA.

DuPont did not provide the bio-monitoring data on its own initiative, and EPA may never have received these data if they had not been originally provided by a third party. Without the bio-monitoring information, EPA
may never have completed the risk assessment that led to the phaseout of
PFOA.

One note of clarification here: EPA has actually note completed the PFOA risk assessment … it completed only a draft document that was reviewed by the Science Advisory Board No real word on when the document will be finalized.