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[SANET-MG] pesticide tests on humans



The article below seems to have allowed  plant incorporated pesticides
(PIPs) such as Bt Cry toxins  to have "slipped the noose"  of
regulation.  This is particularly unfortunate because the Cry gene
products of synthetic genes have not been tested for human safety,
instead bacterial surrogate cry toxins were allowed to be substituted
for the real thing.
Pesticide Testing in Humans: Ethics and Public Policy


Christopher Oleskey,1 Alan Fleischman,2 Lynn Goldman,3 Kurt Hirschhorn,4
Philip J. Landrigan,1 Marc Lappé,5 Mary Faith Marshall,6 Herbert
Needleman,7 Rosamond Rhodes,8 and Michael McCally1
1Center for Children's Health and the Environment, Mount Sinai School of
Medicine, New York, New York, USA; 2New York Academy of Medicine, New
York, New York, USA; 3Department of Environmental Health Sciences, Johns
Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA;
4Departments of Pediatrics, Human Genetics, and Medicine, Mount Sinai
School of Medicine, New York, New York, USA; 5Center for Ethics and
Toxics, Gualala, California, USA; 6General and Geriatric Medicine,
University of Kansas Medical Center, Kansas City, Kansas, USA;
7University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania,
USA; 8Department of Medical Education, Mount Sinai School of Medicine,
New York, New York, USA
Abstract
Pesticide manufacturers have tested pesticides increasingly in human
volunteers over the past decade. The apparent goal of these human
studies is to establish threshold levels for symptoms, termed "no
observed effect levels." Data from these studies have been submitted to
the U.S. Environmental Protection Agency (EPA) for consideration in
standard setting. There are no required ethical guidelines for studies
of pesticides toxicity conducted in humans, no governmental oversight is
exercised, and no procedures have been put in place for the protection
of human subjects. To examine ethical and policy issues involved in the
testing of pesticides in humans and the use of human data in standard
setting, in February 2002 the Center for Children's Health and the
Environment of the Mount Sinai School of Medicine convened an expert
workshop for ethicists, physicians, toxicologists, and policy analysts.
After a peer consensus process, participants developed a number of
ethical and public policy recommendations regarding the testing of
pesticides in humans. Participants also strongly encouraged active
biomonitoring of every pesticide currently in use to track human
exposure, particularly in vulnerable populations, and to assess adverse
effects on health. Key words: biomonitoring, children, ethics, humans,
NOEL, pesticide, testing, U.S. EPA. Environ Health Perspect 112:914-919
(2004). [Online 11 February 2004]


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