EPA's "Fundamental Shift in Moral Thinking"

By Liz Borkowski 

In a commentary in the latest issue of JAMA, Sheldon Krimsky (a member of the planning committee for the Project on Scientific Knowledge and Public Policy, and a contributor to this blog) and Tania Simoncelli examine the EPAâs guidelines for testing pesticides on humans and find that the agency is making âa fundamental shift in moral thinking â and a striking departure from the moral codes that have provided the guidance for human experiments.â

The rule in question is âProtections for Subjects of Human Research,â and the authors begin by summarizing their concerns about it:

Breaking with a long tradition in the ethics of human experimentation that distinguished therapeutic from nontherapeutic agents, the Environmental Protection Agency (EPA) published a final rule in February 2006 on ethical guidelines for enrolling human participants in testing pesticides. Data from such experiments are used to reduce the economic costs in the statutory obligation for companies to protect the food supply from dangerous levels of pesticide residues. The policy gives regulatory standing to experiments that intentionally expose adults to toxic pesticides and could set a precedent for similar experiments involving other industrial chemicals. In addition, the policy opens the door for enrolling children, pregnant women, prisoners, and others in observational studies involving pesticides. It also raises ethical questions about how testing will be conducted in developing countries.

Why would chemical companies want to test pesticides on humans? Because the alternative is to rely on animal studies, and when the EPA does that, they apply additional safety factors â so, the authors explain, âexposure levels of pesticides in food for human consumption can be set by the EPA as much as one thousand times stricter than the animal-derived no-observed-effect level.â If companies submit studies showing that human subjects experience no effects at a pesticide exposure higher than one derived from animal studies plus the safety factor, then the requirements for pesticide residue in food could be eased.

Krimsky and Simoncelli trace the history of this particular rule and relate it to the ethical codes that have previously influenced rules for human experiments to test nontherapeutic agents, including the Nuremberg Code:

Principle 6 of the code states that "the degree of risk to be taken [in an experiment involving humans] should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment." The problem to be solved, according to the EPA, is as follows: "Sometimes . . . data from human research will show that humans are less sensitive-or more sensitive-than animals, and that a less restrictive regulatory measure may provide adequate protection for public health. This is important to know because the Agency is interested in costeffective regulations." Does the problem of finding the "cost-effectiveâ residue of pesticides on food rise to the level of the humanitarian standard in the Nuremberg Code?

The authors also cite the Helsinki Declaration, which states that the risks to human subjects should not exceed the humanitarian benefits of the experiment and that the purpose of medical research involving human subjects is to improve understanding of disease.

What kinds of risks might human subjects be exposed to in studies submitted to the EPA? This isnât just a theoretical question. The authors cite a report from the U.S. House Committee on Government Reform (PDF), which looked at human-subject studies submitted to the EPA and found that the experiments âappear to have inflicted harm on human subjects, failed to obtain informed consent, dismissed adverse outcomes, and lacked scientific validity.â And then, Krimsky and Simoncelli report, âNone of the 16 [human] studies submitted to the EPA between 1992 and 2004, prior to its new rule, was published in the scientific literature or made any pretense at contributing to understanding human disease or to generalizing scientific knowledge.â

In other words, the human subjects bear the risks and the pesticide companies enjoy the benefit. By Nuremberg Code and Helsinki Declaration standards, this is unethical. By EPA standards, itâs cost-effective.

Liz Borkowski works for the Project on Scientific Knowledge and Public Policy (SKAPP) at George Washington Universityâs School of Public Health and Health Services.