WASHINGTON (January 21, 2011) - It will be harder for the chemical industry to use people as test subjects in pesticide research sent to the Environmental Protection Agency, based on an expanded "human testing rule" unveiled late Wednesday.
The dramatic changes EPA has proposed in how it will accept studies that intentionally expose people to pesticides and how these studies can be conducted should force the chemical industry to avoid these types of studies altogether, according to the Natural Resources Defense Council.
"With this new proposal, EPA has cut the incentive for pesticide manufacturers to conduct unethical, and often unscientific, human experiments," said NRDC Senior Attorney Michael Wall. "While it does not ban human testing outright, it sets the bar high enough that studies on people should not be an attractive option as evidence submitted to EPA."
The proposed rule, now open for a 60-day public comment period, results from a 2010 court settlement between the agency, the Natural Resources Defense Council and other public health and farmworker advocacy groups. NRDC filed the lawsuit to prohibit EPA's reliance on these unethical experiments that often led to weakened pesticide safety standards.
"We don't want to see anyone getting paid to dose themselves with toxic pesticides, but if EPA is going to continue to consider studies that use humans when it regulates pesticides, the research needs to adhere to these stricter rules," Wall said.
The existing human testing rule, in place since 2006, allows parents or other authority figures to allow pesticide testing on their children in some circumstances. The proposed rule closes that loophole. The existing rule also only applies to pesticide studies conducted with the intention of being submitted to EPA. With today's proposal, the human testing rule will apply to all studies EPA reviews, whether or not the researchers intended for the study to go to EPA.
The new standards are drawn from National Academy of Sciences recommendations and the Nuremberg Code. Under these new standards, EPA expects the number of such experiments to fall dramatically.
In 2006, EPA lifted a moratorium on its use of experiments in which people are purposely dosed with pesticides to assess toxic effects. In some studies, public records show that researchers paid people to eat or drink pesticides, to enter pesticide vapor "chambers," or to have pesticides sprayed into their eyes or rubbed onto their skin. The pesticide industry submitted results of such tests to EPA to use as part of its review on pesticide safety. Although some tests were designed in ways that could miss health effects that would occur in the broader population, EPA's rule allowed use of the tests to weaken health protection standards.
"Some of the worst scientific reports I have read are these industry-funded pesticide studies where no more than a handful of adults are dosed with a toxic pesticide, and then the companies try to argue away complaints of headaches, nausea, and even vomiting," said NRDC Senior Scientist Jennifer Sass. "In one experiment, the people tested were even told that the chemical was a medicine instead of a pesticide."
NRDC, a coalition of health and environmental advocates, and farmworker protection groups filed a lawsuit against EPA in 2006, claiming that its rule violated a law Congress passed a year earlier requiring strict ethical and scientific protections for pesticide testing on humans.
The coalition argued in the U.S. Court of Appeals for the Second Circuit the rule ignores scientific criteria proposed by the National Academy of Sciences, did not prohibit testing on pregnant women and children, and even violated the Nuremberg Code, including the requirement of fully informed consent. The Nuremberg Code is a set of standards governing medical experiments on humans that was put in place after World War II, following criminal medical experiments performed by Nazi doctors.
The 2006 lawsuit was brought by the Farm Labor Organizing Committee, Migrant Clinicians Network, NRDC, Pesticide Action Network North America, United Farm Workers, Pineros y Campesinos Unidos del Noroeste (Northwest Treeplanters and Farmworkers United) and the San Francisco Bay Area Physicians for Social Responsibility. Attorneys with NRDC, Earthjustice, and Farmworker Justice served as legal counsel for the coalition.
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