October 12, 2005

EPA Proposes New Rules for Human Dosing Experiments

Critics argue too many loopholes remain

by Andrea Smith

The Dominion - http://www.dominionpaper.ca

The US Environmental Protection Agency (EPA) unveiled a new set of guidelines this month that, according to the agency, "establish stringent enforceable ethical safeguards" on research conducted by third-parties intentionally exposing human subjects to pesticides. Susan Hazen, from the EPA's Office of Prevention, Pesticides, and Toxic Substances, says that the agency wants "to send a clear signal to the public that unethical research should never be conducted and will not be accepted by EPA." The rules pertain to third-party human dosing studies, where human subjects are intentionally exposed to chemicals which have no medical benefit. While previously banned by the EPA, they are now mandated by the Appropriations Act, 2006, signed by Bush on August 2nd, which states the EPA must have a set of rules in place for third-party intentionally human dosing studies no later than February 1, 2006.

The Act bans testing chemicals on "volunteers" who are children, infants or pregnant women.

But such a clear ethical message isn't readily found in the details of the rules. The thirty-page document, intended for public comment, holds numerous contradictions and loopholes. Testing on "abused or neglected" children is acceptable without permission from parents or guardians. Another ethically contentious rule is the EPA's ability to use industry studies conducted overseas, performed in countries that have minimal or no ethical standards for testing, so long as the tests are not done directly for the EPA. And while numerous sections detail the strict conditions of subjecting pregnant women, children and infants to intentional chemical exposures, they are ultimately undermined by a rule stating that unethical research (which includes research on pregnant women and kids) can be used should they provide important data needed for a regulatory decision.

And what of the consequences for conducing unethical research? Action the EPA can take includes refusing to rely on unethical research and disqualifying the institution that approved or conducted the research from receiving federal funding.

The revised rules require that studies, whether conducted or sponsored by the EPA or by another party such as industry or academia, comply with the Common Rule: the current ethical standards for research conducted or supported by the US federal government. Researchers are required to submit study protocols to the agency's Human Studies Review Board for scrutiny before they are conducted. Once the study is completed, researchers must report to the EPA on how the ethical standards were met.

Such a process is meant to prevent the ethical violations of previously submitted trials. To date, the EPA has received 24 human dosing studies. Most have not been published, and are therefore not peer reviewed. Some bioethicists and scientists have raised additional concerns with the studies. In a report examining six of the human dosing experiments submitted by industry to the EPA, Dr. Alan Lockwood stated that "all had serious ethical or scientific deficiencies – or both." These deficiencies include inappropriate methods and distorted result, and lack of informed consent. For example, in one study investigating the health effects of the pesticide cholrpyrifos, the subjects were informed that "low doses of these agents [cholinesterase inhibitors] have been shown to improve performance on numerous tests of mental function." What subjects weren't told was that none of the chemicals classified as performance enhancers are organophosphates, a class of chemicals well-known to negatively affect the central nervous system.

Another ethical issue not addressed by the proposed rules is conflict of interest. The $10 billion dollar chemical industry certainly has a lot at stake in the issue. When the EPA proposed a moratorium on the submission of human dosing experiments in 2001, the chemical industry sued – and won. Welcoming the decision to allow human pesticide testing, industry representatives stated that "the EPA does not need to be overly restrictive when it sets pesticide exposure levels." Industry favours human dosing studies because they can be used to establish levels of no adverse effect (NOELs), often at levels higher than those from animal studies. In terms of environmental regulation, that means that more pesticides can be applied, and higher exposures seen as acceptable.

However, many scientists agree with industry's position on the need for human studies. Reversing the prior moratorium on the use of human subjects, a National Academy of Science (NAS) panel reviewing the issue stressed that the use of human subjects was appropriate only to answer important regulatory questions that could not be answered without such studies, and in such incidences, there exists a public benefit to using "the best available science." The logic is that other methods, such as animal testing, often provide limited and inaccurate answers as to the health effects in humans. Yet human dosing studies are often conducted over short durations, such as a period of 6 months, and are therefore not long enough for most negative health conditions, such as cancer, to manifest. Moreover, EPA's proposed rules diverge from the NAS recommendations in a number of important respects. They ignore the recommendation for an independent review panel, and permit a far broader range of research than initially proposed. Erik Olsen with the Natural Resource Defence Council suggests, "if the rule stays as this draft has proposed, the floodgates will open for human testing."