Risk Communication in EPA's Controlled Inhalation Exposure Studies and in Support
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Risk Communication in EPA's Controlled Inhalation Exposure Studies and in Support
ABSTRACT

On March 28, 2017, the National Academy of Sciences, Engineering, and Medicine (NASEM) released a much-anticipated report on the Environmental Protection Agency's controlled human inhalation exposure studies. This essay reviews the ethical controversies that led to the genesis of the report, summarizes its key findings, and comments on its approach to informing human subjects about the risks of inhalation exposure studies. NASEM's report makes a valuable contribution to our understanding of the scientific and ethical issues involved in conducting human inhalation exposure studies. Its definition of "reasonably foreseeable risks" provides useful guidance to investigators, research participants, and institutional review board members.

On March 28, 2017, the national Academy of Sciences, Engineering, and Medicine (NASEM) released a much-anticipated report on the Environmental Protection Agency's (EPA) controlled human inhalation exposure studies. To understand the genesis of the document, a quick review of recent events is in order. [End Page 117]

A Short History of the EPA's Controlled Exposure Studies

Prior to 2006, the EPA adopted the Common Rule for intramural or extramural research funded by the agency.1 Although the EPA did not have a formal policy that applied to research sponsored by private companies (third-party research), it applied scientific and ethical standards to these studies on a case-by-case basis. In the 1990s, in support of requests to the agency to loosen its restrictions on pesticide residues on foods, private companies submitted data to the EPA from experiments that exposed human subjects to pesticides. The Environmental Working Group and other critics claimed these studies were unethical, because they exposed human subjects to excessive risks and would benefit industry but not society (Resnik 2012).

In 1998, the EPA decided it would no longer accept data from third-party human exposure studies for its regulatory decision-making and asked the National Research Council (NRC) to study the scientific and ethical issues involved in human pesticide experiments. Industry organizations objected to this decision and argued that the EPA had engaged in inappropriate rule-making, because it had formulated a policy without prior notice and public comment. A federal court agreed and ordered the agency to engage in appropriate rule-making concerning its human research regulations (Resnik 2012). In 2004, the NRC released its report, which concluded that the EPA could rely on third-party research for regulatory decision-making if it meets appropriate scientific and ethical standards. The report also recommended that the EPA adopt the Common Rule for third-party studies and establish a board to review such studies.

In the fall of 2004, as the EPA was beginning its rule-making, an ethical controversy emerged that had a dramatic impact on the outcome of this process. The Organic Consumers Association and other environmental groups alleged that a study known by the acronym CHEERS (Children's Environmental Exposure Research Study) unethically exposed children to pesticides and targeted poor, minority groups. CHEERS was an observational study sponsored by the EPA, the Centers for Disease Control and Prevention (CDC), and the Duvall County Health Department. The study was designed to measure children's in-home exposures to pesticides and other household chemicals. The investigators planned to recruit families of young children living in the Jacksonville, Florida, area who used high amounts of pesticides in their homes. Later, a control group of low pesticide-using families was added. The study involved five home visits over a two-year period and required parents to keep records of their use of pesticides and other chemicals and their children's activities. During the home visits, the investigators [End Page 118] would collect dust and soil samples from the home and blood and urine samples from the children.

Three institutional review boards (IRBs) approved the CHEERS study and classified it as minimal risk (Resnik 2012).2 However, critics claimed that CHEERS was an intentional exposure study, because parents would be exposing their children to pesticides and other chemicals. This criticism misrepresented the study design, because the investigators sought to collect data on children's exposures that were already occurring in...