http://www.peer.org/news/news_id.php?row_id=538
June 16, 2005
New Release from: Public
Employees for Environmental Responsibility (PEER)
Contact: Chas Offutt (202) 265-7337
EPA ENCOURAGING PESTICIDE COMPANIES
TO CONDUCT HUMAN STUDIES — Proposed New Rules Lack Any
Ethical Protections for Study Subjects
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 creating.”
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.
###
View the public comment extension notice in the June 8, 2005,
Federal Register at 70 FR 33414 (at page2)
Look
at the proposed new pesticide data requirements at 70 FR 12276
(beginning at page 6)
See pages 12292 to 12302 for human testing provisions
And pages 12312 to 12313 for lack of ethical safeguards
Read
the PEER comments on lack of safeguards in EPA policy
For
background on EPA’s drive to promote human dosing studies
