WASHINGTON, DC, May 9,
2005 (ENS): To win Senate confirmation as administrator
of the U.S. Environmental Protection Agency (EPA) last month, then
Acting EPA Administrator Stephen Johnson canceled a planned study
in which parents were to be paid to expose their infant children
to pesticides. But now the agency is finalizing a new policy that
permits the same type of human dosing studies by industry.
Today the EPA closes public comment on its policy of accepting the
results of experiments that intentionally dose humans with pesticides
and other chemicals on a wide open case-by-case basis, without defining
what criteria are required of experimenters.
The agency does not define what ethical lapses would disqualify
an industry submission from being used for regulatory purposes.
During his Senate confirmation hearing, Johnson disclosed that
the EPA has funded or is currently funding than 250 experiments
on human subjects, several of which involve chemical testing on
- Exposing children ages 3 to 12 to the agricultural insecticide
chlorpyrifos to test absorption in their systems through “urinary
- Paying 12 “young male volunteers” to inhale methanol
vapors at levels described as “a worst case scenario”
- Having asthma sufferers inhale potentially harmful ultrafine
The study that was canceled was financed jointly by EPA and industry.
Called CHEERS (Children’s Environmental Exposure Research
Study) it would have paid Florida parents to apply pesticides and
other chemicals in the rooms primarily occupied by their infant
"Under the current review process at EPA there is no way for
the public to know what studies EPA is conducting or supporting,
or to know where in the review process those studies may be, said
Public Employees for Environmental Responsibility (PEER), a national
organization that represents government workers in natural resources
agencies, in its comment on this policy filed today.
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, PEER commented.
"It is even more alarming that until the CHEERS controversy
surfaced, EPA regional office staff did not know that studies they
conduct or support are subject to HHS [Department of Health and
Human Services] regulations, PEER wrote.
"It is hard to believe that these are truly the criteria by
which EPA judges human subject studies, because they would be clear
violations of HHS regulations," wrote PEER.
"EPA should never accept or use data from any human subject
study if there is even the slightest evidence of intentional harm,
serious or otherwise. EPA should never accept or use data from any
human subject study if there is any evidence that adequate informed
consent was not obtained. To hold third-party researches to such
low standards justifies past unethical behavior, encourages unethical
behavior in the future and allows for unnecessary risks for countless
human study participants," the employees' organization wrote.
“The Bush administration is setting the ethical bar so low
that only the most sleazy cannot limbo under it,” warned 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.”
In its policy notice in the Federal Register, published February
8, the EPA defers adopting legally binding protections for infants,
fetuses, pregnant women, and prisoners that apply to all medical
and drug testing overseen by the Department of Health and Human
Services. Instead, EPA announces that it "indends to publish
a proposed rule" at some time in the future.
The agency says that any research on human subjects conducted or
supported by the EPA is subject to the principles of the 1979 Belmont
Report, known as the Common Rule. These principles include such
basics as informed consent about the research procedure, purposes,
risks and anticipated benefits, and a statement offering the subject
the opportunity to ask questions and to withdraw at any time from
But third party studies, conducted by groups not supported by federal
money, are not subject to the Common Rule. "EPA should establish
a system to describe and track all human subject studies, and put
this system on its website. It should establish agency-wide training
on the requirements of the Common Rule for all staff conducting,
granting money for, or reviewing human subject studies," PEER
PEER said in a media statement today that "the 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."
In its policy statement, the EPA says it "may propose to adopt
some or all of the HHS regulations that provide additional protections
for certain populations of vulnerable subjects." This proposal
"may" require a sponsor or investigator to provide the
protocol for the human studies to the EPA for prior review and approval.
But the guidelines proposed by the agency are all voluntary and
non-binding upon the experimenters, the EPA and the public, the
Read the PEER comments on lack of safeguards in EPA policy: http://www.peer.org/docs/epa/05_9_5_comments.pdf
See EPA’s “No Safeguards” Human Testing Policy
Look at other EPA human dosing experiments: http://www.peer.org/docs/epa/05_9_5_humandosing.pdf