By MICHAEL DOYLE
January 24, 2006
After fielding some 50,000 public comments on its earlier human-testing proposals, the Environmental Protection Agency is setting out final rules that officials call tough and fair. But Democrats and environmentalists are raising an outcry, and courts could remain busy sorting it all out.
"The fact that EPA allows pesticide testing of any kind on the most vulnerable, including abused and neglected children, is simply astonishing," Sen. Barbara Boxer, D-Calif., declared Monday.
The new rules would prohibit regulators from using so-called "intentional exposure" research that involved children or pregnant women. But under what regulators described as "narrowly defined circumstances," such research could still be used - if the researcher hadn't originally intended to submit the results to the EPA.
The new rules require researchers to document their compliance with ethical guidelines, but exempt certain overseas tests. Testing on adults could proceed, following review by a new Human Studies Review Board that could "comment on" but not stop a proposed experiment.
"EPA does not want to ignore potentially important information," the agency states in its final rule. "At the same time, the agency's conduct should encourage high ethical standards in research with human subjects."
Boxer and several colleagues were one step ahead of the EPA Monday, which hadn't yet formally released the final rules protecting human subjects. But a leaked draft of the new rules, spanning some 100 pages, spells out both the new regulations and how they will be presented to the public.
EPA officials could not be reached to comment Monday.
"Humans process some substances differently from animals," the EPA notes in its final rule, scheduled for publication in the daily Federal Register. "Studies of this kind can provide essential support for safety monitoring programs. Animal data alone can sometimes provide an incomplete or misleading picture of a substance's safety or risk."
The 50,000 comments received by the EPA since last September showcase the level of public interest, although regulators noted that 99 percent of the comments were part of an e-mail or organized letter-writing campaign.
The American Mosquito Control Association, among others, previously advised lawmakers that human testing is necessary in order to develop new and safer chemical alternatives. Otherwise, the mosquito control group warned, diseases like the West Nile Virus could spread more readily.
"Let's look at things as they really are in the world around us," Montana Republican Sen. Conrad Burns said during debate last year. "We do not touch anything folks ... we do not do anything in this environment around us where there are no chemicals."
Burns failed and Boxer prevailed, as the Senate in June imposed a moratorium on the EPA's use of human pesticide testing; the House had adopted a similar moratorium authored by Los Angeles Democrat Hilda Solis. The moratorium came following reports of some studies involving the intentional swallowing of pesticides.
The moratorium is in place until the final rule takes effect, which will be 60 days after publication. But if environmentalists conclude that "loopholes" will result in laws being broken, further lawsuits will likely follow.
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