Dear Friends:
This is from truthout.org
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EPA on Threshold of Brave New World of Human Testing
Public Employees for Environmental Responsibility
Monday 09 May 2005
EPA Invites Industry to Mimic Practices of Discontinued CHEERS Study.
Washington, DC - In the wake of the recent cancellation of the CHEERS study
in which parents were to be paid to expose their infant children to
pesticides, the U.S. Environmental Protection Agency is finalizing a new policy that
encourages the same type of human dosing studies by industry. Today EPA closes
public comment on its "no safeguards" policy of accepting all human subject
experiments submitted by industry, according to a filing today by Public
Employees for Environmental Responsibility (PEER).
Under its new policy, EPA would accept all human chemical dosing studies
"unless there is clear evidence that the conduct of these studies was
fundamentally unethical… or was significantly deficient relative to the ethical
standards prevailing at the time the study was conducted." Since industry is not
required to disclose the conditions under which experiments were conducted, it
is not clear how EPA will ever learn of "fundamentally unethical" practices.
Moreover, EPA is unwilling to define what ethical lapses would disqualify an
industry submission from being used for regulatory purposes.
"The Bush Administration is setting the ethical bar so low that only the
most sleazy cannot limbo under it," stated PEER Program Director Rebecca Roose.
"The basic problem is this: the safeguards that apply to experiments
involving development of drugs to help people are far more stringent than EPA's
standards for experiments to determine how much commercial poisons harm people."
EPA's refusal to adopt basic safeguards requiring proof of informed consent,
independent review or protections for children is part of a Bush
Administration drive to liberalize rules on human testing of pesticides and other
chemicals. Without actual human experimental data to justify higher chemical
exposures for children, industry must abide by the 1996 amendments to the Federal
Food, Drug and Cosmetic Act setting ten-fold stricter exposure standards for
children.
At the same time it is encouraging industry to expose human subjects, EPA
itself is conducting similar experiments that serve to provide a template for
industry. Last month to avoid a hold on his confirmation, EPA Administrator
Stephen Johnson reluctantly cancelled a controversial study financed jointly by
EPA and industry called CHEERS (Children's Environmental Exposure Research
Study) that would have paid Florida parents to apply pesticides and other
chemicals in the rooms primarily occupied by their infant children. During his
confirmation, Johnson disclosed that EPA is also conducting more than 250 other
human experiments, several of which involve chemical testing on children,
including
* Exposing children (ages 3 to 12) to a powerful agricultural
insecticide (chlorpyrifos) to test absorption in their systems through "urinary
biomarker measurements";
* Paying "young male volunteers" to inhale methanol vapors at levels
described as "a worst case scenario"; and
* Having asthma sufferers inhale potentially harmful ultrafine carbon
particles.
"The need for safeguards is particularly acute because EPA is giving
industry an economic incentive to push the edge of the ethical envelope," Roose
added. "It is distressing that a federal agency is using tax dollars to write a
primer for commercial exploitation of human subjects."
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Nikki Lee RN, MS, Mother of 2, IBCLC, CCE
Maternal-Child Adjunct Faculty Union Institute and University
Film Reviews Editor, Journal of Human Lactation
Support the WHO Code and the Mother-Friendly Childbirth Initiative
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