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Source: Public Employees for Environmental Responsibility (PEER)

Posted by: Public Employees for Environmental Responsibility - archive

Posted on: Nov 30, 2004 @ 10:00 am

 

Press Release

 

For Immediate Release: Tuesday, November 30, 2004

Contact: Chas Offutt (202) 265-7337

EPA SET TO ACCEPT HUMAN PESTICIDE DOSING STUDIES

Senior Agency Officials to Decide Ethical Concerns on Case-By-Case Basis

 

Washington, DC In a notice slated for publication in the Federal Register,

the U.S. Environmental Protection Agency is announcing that it will accept

experiments using human subjects submitted by pesticide companies and

chemical manufacturers, according to a document released today by Public

Employees for Environmental Responsibility (PEER). Under the new system,

EPA imposes no rules to prevent unethical practices but will instead make

decisions concerning ethically problematic studies on a case-by-case basis.

 

In its notice, EPA defers developing enforceable ethical standards until an

unspecified future time. The agency attributes this ad hoc policy to

continuing public debate about ethical standards. Thus, under this interim

policy, EPA will accept human experimental data unless there is clear

evidence of fundamentally unethical conduct, such as harm to the

participants or some form of undue coercion.

 

By this sleazy move, EPA abdicates its moral responsibility to ensure that

the data submitted by industry does not use human beings as chemical guinea

pigs, stated PEER Executive Director Jeff Ruch, noting that EPA will

officially assume that all human dosing experiments are done ethically

unless conclusively proven otherwise. Under this plan, even if ethical

concerns do surface, EPA s political appointees will act as the sole

arbiters, guided only by their own moral compasses.

 

EPA has yet to adopt safeguards that are in place at other federal

agencies, such as the FDA, providing special protections for experiments

involving pregnant women, fetuses and children. In addition, EPA does not

prohibit payments to induce subjects to volunteer, nor does it require

independent review of study ethics.

 

This latest notice applies only to experiments conducted by industry

without the participation of, or funding from, EPA. Recently, EPA itself

proposed to conduct a controversial study that would pay parents to spray

pesticides and other chemicals in the rooms occupied by infants under age

3. When that study (with the acronym CHEERS) drew unfavorable publicity

earlier this month, EPA announced further review even though it had already

recruited families with half of the 60 children called for in the study

design. CHEERS and similar studies with direct EPA involvement are outside

the scope of this new notice and are also proceeding on a case-by-case

basis, without any policy guidance.

 

Industry has been pressing the Bush Administration to liberalize rules on

human testing of pesticides and other chemicals. This industry pressure

follows the 1996 amendments to the Federal Food, Drug and Cosmetic Act

setting ten-fold stricter exposure standards for children absent reliable

data showing no harm. Industry needs actual human experimental data to

justify higher chemical exposures for children.

 

Can toddlers ever give informed consent for chemical experimentation? EPA

apparently thinks so, added Ruch. No civilized country would encourage

using infants as subjects for testing potentially harmful substances that

have no medical or other countervailing benefit to the child.

###

 

See the draft EPA notice on Human Testing: Proposed Plan and Description of

Review Process

 

Read about questionable human dosing studies that EPA is accepting now

Article by Dr. Alan Lockwood (American Journal of Public Health, vol. 94 [

2004] 1908)

 

Find out about EPA s plan to pay poor parents to dose their infants with

pesticides

http://www.peer.org/press/530.html

http://www.peer.org/EPA/LockwoodHumanPesticideTests_article.pdf