Pesticide tests may use pregnant women, kids

"Pesticide tests may use pregnant women, kids", Seattle
Post-Intelligencer, January 24, 2006,
Link: http://seattlepi.nwsource.com/health/256785_epa24.html

The Bush administration would allow some limited pesticide testing on
children and pregnant women under controversial rules set to be made
final as early as this week.

After fielding about 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 about 100
pages, spells out both the new regulations and how they will be
presented to the public.

EPA officials could not be reached for 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.

In June, the Senate imposed a moratorium on the EPA's use of human
pesticide testing; the House had adopted a similar moratorium. The
moratorium is in place until the final rule takes effect, which will be
60 days after publication.