EPA on Threshold of Brave New World of Human Testing

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http://www.truthout.org/docs_2005/051005X.shtml

 

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 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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See EPA's No Safeguards " Human Testing Policy Notice .

 

Look at other EPA human dosing experiments .

 

Find out more about the need for safeguards .

 

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