The C8 Health Project and C8 Science Panel (2004–2013)

During a thirteen-month period between 2005 and 2006, over 69,000 people across Ohio and West Virginia gave samples of blood and answered surveys as part of the C8 Health Project, a medical monitoring program studying chemical pollutants. Researchers with the C8 Science Panel then analyzed the data from the C8 Health Project. Over the next eight years, the C8 Health Project and C8 Science Panel operated jointly as a scientific institution formed through a court order to determine what ill health effects a chemical called perfluorooctanoic acid, or PFOA, can cause to the human body. PFOA is an example of a "forever chemical" because it persists in the environment without breaking down. The C8 Science Panel determined that there is a probable link between PFOA exposure and pregnancy-induced high blood pressure, testicular cancer, high cholesterol, and several other diseases. The work of the C8 Health Project and C8 Science Panel led to a personal-injury settlement against the DuPont chemical company, shaped public policy, and influenced future investigations into the health effects of similar chemicals.

1. Origin and Structure of the C8 Health Project and C8 Science Panel
2. Recruitment and Community Engagement
3. Scientific Leadership of the C8 Science Panel
4. Research Methods and Outcomes Related to Reproductive and Developmental Health
5. Influence on Policy and Global Research

Origin and Structure of the C8 Health Project and C8 Science Panel

The C8 Health Project and C8 Science Panel were created as part of a settlement from the Wood County Court case Jack W. Leach, et al. v. E.I. du Pont de Nemours & Company (2005), hereafter Leach v. du Pont. Plaintiffs filed that case after people living near the Washington Works facility in Washington, West Virginia, operated by the DuPont chemical company, discovered that their drinking water contained PFOA. The chemical is sometimes called “C8” due to the eight carbon atoms in its molecular structure, C₈HF₁₅O₂. It is part of a group of human-made chemicals called per- and polyfluoroalkyl substances, or PFAS, commonly used in industrial and consumer products. PFAS are often called “forever chemicals” because they persist in the environment and the human body for long periods without breaking down. Though limited research on PFAS existed up to that time, evidence from animal studies and internal documentation from DuPont regarding health effects on factory workers suggested possible links to cancer, endocrine disorders, and reproductive harm.

On 30 August 2001, more than 80,000 people filed a class-action lawsuit against DuPont. The resulting case, Leach v. du Pont, did not go to trial. Instead, the parties reached a settlement in November 2004, in which DuPont agreed to fund a process of data gathering and analysis for the exposed population. The study began with blood sampling and medical-history surveys through a program called the C8 Health Project. After that collection phase, a group of epidemiologists, forming the C8 Science Panel, analyzed the data. The panel’s findings were then used to determine whether PFOA exposure had a probable link to specific diseases.

People living in areas with contaminated water supplies could only bring personal-injury lawsuits for those PFOA-linked conditions after the panel completed its work.

The settlement established the C8 Health Project and C8 Science Panel to help evaluate health claims within a legal framework. The agreement reached in Leach v. du Pont required a process of scientific inquiry to act as a gatekeeper. Before affected individuals could pursue financial compensation for ill-health effects, they had to wait for a determination that PFOA was the likely cause. The two programs operated as independent but coordinated bodies. The court settlement specified that the C8 Science Panel would include three experts in epidemiology, the study of causes of a disease in a population, with no financial or institutional ties to DuPont or to the plaintiffs.

Recruitment and Community Engagement

To carry out the C8 Health Project, the court settlement led to the formation of a new company, Brookmar, Inc., in 2005. To ensure individuals in the affected areas had a chance of participating, Brookmar publicized the project through open meetings in the affected water districts, messages through its website, a phone bank, and press conferences. Participation was voluntary, with eligible participants receiving $150 for the survey portion and $250 for giving a blood sample, money drawn from the settlement sum of 70 million US dollars in class benefits. Residents of the affected water districts had the opportunity to participate for a period of thirteen months.

By mid-2006, 69,030 people had provided blood samples and completed medical surveys. The number represented nearly eighty percent of the resident population in affected water districts. The data collected included personal and family medical history, pregnancy history and outcomes, water sources and uses, and self-diagnoses. Laboratory testing measured levels of PFOA and other PFAS compounds in the blood of participants, and they received the results. The average PFOA levels in their blood was five times the national average. At the time, there was no officially established safe blood level for PFOA.

Scientific Leadership of the C8 Science Panel

The C8 Science Panel consisted of three scientists: Tony Fletcher, David Savitz, and Kyle Steenland. Fletcher, a researcher and lecturer who focuses on social and environmental health at the London School of Hygiene & Tropical Medicine in London, England, had studied chemical exposures and water and air pollution. Savitz, professor of community health, obstetrics, and gynecology at Brown University in Providence, Rhode Island, specialized in reproductive epidemiology. Steenland, professor of environmental and occupational health at Emory University in Atlanta, Georgia, had investigated epidemiology in workplaces and natural and human-made environments. Even though all three had a university affiliation, each participated in the C8 Science Panel under the terms of the legal settlement. Their mandate was to evaluate whether there was a probable link between PFOA exposure and specific human diseases. The three scientists directed the research themselves and filed regular reports with the Wood County Court that controlled and publicized their findings.

Research Methods and Outcomes Related to Reproductive and Developmental Health

To determine the effects of PFOA on human health, the panel had to reconstruct how the participants became exposed to PFAS. The scientists developed models to estimate how much PFOA each participant had in their blood at different times in the past. With those exposure estimates, the panel conducted a series of studies. Some were cross-sectional studies, performed to determine correlation between PFOA levels in blood to health conditions. Others were longitudinal studies using estimated past exposures to study the onset of disease over time. In addition, they investigated probable links with reproductive health, cancers, suppression of the immune system, thyroid disease, and cardiovascular disease. Moreover, the panel reviewed over 11,000 pregnancies to examine whether higher PFOA exposure was associated with miscarriage, preterm birth, low birth weight, and pregnancy-induced high blood pressure.

In October 2012, after seven years of data collection and research, the C8 Science Panel released its final findings. Of the many possible health outcomes investigated, the panel determined that six had a probable link to PFOA exposure. One of them, pregnancy-induced high blood pressure, has the potential for direct impacts on reproductive health, such as reduced blood flow, and therefore oxygen and nutrients, to the fetus and premature or underweight birth. It also increases the risk of kidney damage in the mother and of chronic conditions like heart disease and dysfunction of the metabolism, the total chemical processes that convert food into energy and maintain an organism’s cells, in both mother and child. In their findings the panel highlights that individuals with higher PFOA exposure had an increased likelihood of developing high blood pressure during pregnancy, a condition that can threaten both maternal and fetal health.

Other outcomes, while not exclusively related to reproductive health, still have implications for fetal development. Thyroid disease was linked to PFOA exposure, and thyroid hormones play a critical role in fetal brain development and metabolism. Testicular cancer, another linked condition, raised questions about PFOA’s effects on male reproductive organs. Although the panel did not find a probable link to miscarriage, infertility, or birth defects, their findings informed future research on how PFAS may affect embryos and fetal development. Later studies, using data from the C8 Health Project, explored associations between PFAS and lower birth weight, earlier menopause, and altered hormone levels during pregnancy.

Influence on Policy and Global Research

Although the C8 Health Project and C8 Science Panel began as a local response to contamination, its findings influenced regulatory decisions nationally and internationally. The US Environmental Protection Agency, or EPA, cited the panel’s findings in multiple health advisories for PFAS in drinking water. State-level health departments in New Jersey, Michigan, and New York also used the panel’s methods as a model for their own investigations to assess the dangers of PFAS. Outside the United States, researchers in China, Sweden, Australia, and Italy applied similar study designs to examine communities exposed to PFAS chemicals.

By the time the C8 Science Panel filed its final report in October 2012, it had produced twenty-three peer-reviewed publications, developed one of the largest human datasets on PFAS exposure, and helped shape how regulators approach chemical risk. Over forty additional scientific publications on PFOA and other PFAS continued to be published by the panel members through January 2020. As a legally created scientific institution, the C8 Health Project and C8 Science Panel influenced not only the fields of toxicology and epidemiology but domestic and international law and public health practices, and global environmental science. They did not constitute a traditional research institution and did not follow the normal path for scientific research. By tracing how a chemical moved through water, blood, and bodies, their findings helped link environmental contamination to developmental-biology impacts on pregnancies, hormones, and early fetal growth.

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