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
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 children, including:
- Exposing children ages 3 to 12 to the agricultural
insecticide chlorpyrifos to test absorption in their
systems through “urinary biomarker measurements.”
- Paying 12 “young male volunteers” to
inhale methanol vapors at levels described as “a
worst case scenario”
- Having asthma sufferers inhale potentially harmful
ultrafine carbon particles
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 children.
"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.
"The Bush administration
is setting the ethical bar so low that only the
most sleazy cannot limbo under it.”
- PEER Program Director Rebecca Roose
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,
"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,"
"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 the research.
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 wrote.
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
But the guidelines proposed by the agency are all voluntary
and non-binding upon the experimenters, the EPA and
the public, the agency states.
Read the PEER comments on lack of safeguards in EPA
See EPA’s “No Safeguards” Human Testing
Policy Notice: http://www.peer.org/docs/epa/05_9_5_notice.pdf
Look at other EPA human dosing experiments: http://www.peer.org/docs/epa/05_9_5_humandosing.pdf