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Washington, DC — In recent Federal Register notices, the
U.S. Environmental Protection Agency is proposing that pesticide companies submit
human exposure experiments when seeking to market new chemicals or broaden the
application of existing ones. EPA is not, however, requiring the industry to
observe any ethical safeguards, such as informed consent, no undue risk to participants
and exclusion of infants or other vulnerable populations, according to Public
Employees for Environmental Responsibility (PEER).

These new policies hang in the balance while Congress debates whether to prohibit
the agency from accepting any human pesticide dosing studies. Such a ban has
already passed in the House of Representatives and consideration of a similar
amendment is imminent in the Senate. Just weeks ago, 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 in order to remove
Senate objections to his confirmation.

Nonetheless, the agency is signaling a desire to propel a much broader, industry-driven
human experimentation agenda. In its latest notice filed on June 8th, the agency
promised that the proposed pesticide rule for toxic agents is “the first
of several planned changes.”

In its new proposal, EPA would revamp nearly 20-year old data requirements
for pesticides by encouraging the companies to submit human dosing studies “in
addition to, or in lieu of” conventional animal studies or background
environmental exposure studies, because —

  • The human dosing studies may eliminate the need for pesticide companies
    to pay for expensive toxicological testing in cases where the human subjects
    evidence no detectible harm; and
  • Background environmental exposure tests “usually overestimate exposure
    because they only provide estimates of potential exposure, not measurements
    of absorbed dose.”

“The issue here is not the march of science but whether standards of
basic decency will be applied to experiments conducted for commercial gain,”
stated PEER Executive Director Jeff Ruch, whose organization has been relaying
ethical concerns raised by EPA’s own scientists. “It is beyond ironic
that EPA claims these studies are required to protect human health while turning
its back on the health risks posed to the troops of human guinea pigs it is

At a recent EPA office groundbreaking in Denver, Johnson decried Congressional
interference in the CHEERS study. Not only has Johnson personally championed
the pesticide industry drive to legitimize widespread human dosing work but
he has also refused to require that industry studies conform with informed consent
rules or safeguards for infants, pregnant women, fetuses and other vulnerable
groups that apply to all medical experiments submitted to regulatory agencies
such as FDA or research bodies, such as NIH.

The new rules will likely result in thousands of corporate sponsored human
dosing studies each year, in part because EPA states that it “generally
is not allowing surrogate data” using other benign chemicals. Instead,
the agency “encourages applicants and registrants to generate needed exposure
data using the pesticide product for which the registration is sought.”
This requirement will mean separate batteries of human dosing for each new chemical
or new application in order to build a meaningful database.


the public comment extension notice in the June 8, 2005, Federal Register at
70 FR 33414
(at page2)

at the proposed new pesticide data requirements at 70 FR 12276
at page 6)
See pages 12292 to 12302 for human testing provisions
And pages 12312 to 12313 for lack of ethical safeguards

the PEER comments on lack of safeguards in EPA policy

background on EPA’s drive to promote human dosing studies

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