green light. An expert panel said EPA should consider accepting studies that expose human volunteers to pesticides used on crops.
Federal regulators should be allowed to use controversial studies in which people are intentionally dosed with pesticides, a group of experts decided. The report from the National Research Council (NRC) concluded that these tests may be acceptable if they meet the scientific and ethical standards. Environmental groups criticized the report as full of loopholes and urged the Environmental Protection Agency (EPA) to put a moratorium on pesticide testing, they maintain are unethical.
The question has been raised because of a 1996 law that requires EPA to tighten the limits on exposure to pesticides to protect children. To compensate for this, companies have started sending EPA human studies to move a fudge factor used in the standards based on rat data. This factor is called the security is applied to the results from animals in cases where people are more sensitive than rats. But the EPA has placed a hold on human testing after the Environmental Working Group (EWG), an advocacy group based in Washington, released a report slamming several of these studies in the UK. Later, the agency asked the NRC to take a look at all human dosing studies, including volunteers exposing to air pollutants and water. Meanwhile, last year a court ordered the EPA to consider pesticide tests on a case by base basis.
The panel, chaired by James Childress ethicist at the University of Virginia, found that these tests are not intrinsically unethical: Improve the science behind a regulatory decision "is a benefit to society which may justify the conduct of a human dosing study, "the report said. EPA should accept the data, he adds, if they are scientifically valid, the information can not be obtained in other ways, and studies comply with federal ethics standard known as the common rule.
In addition, a kind of test - which is to try to eliminate animal to human safety factor - should be accepted if the participants not experience adverse effects. This usually means the metabolism studies wherein volunteers are given lower doses which do not cause symptoms, but cause chemical changes detectable in the blood and urine.
The report recommends new obstacles, however. He said the EPA, which has no ethics committee of its own, should establish a review panel for the Humanities to offer companies advice before they undertake a study and to help EPA decide which studies to accept.
Regarding the 19 trials have already been submitted to the EPA, most of them metabolism studies, the report said they could be used if they are found to meet the standards the report. According to Patrick Donnelly, executive vice president of CropLife America, "They all will." But toxicologist Jennifer Sass of the Natural Resources Defense Council disagrees. It examined several, and "none of them have any [scientific] validity," she said
Related Sites
Intentional of human dosing studies to the EPA regulatory purposes: scientific and ethical issues
Environmental Working Group press release and the 1998 report
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