The ethics of human testing may be decided case by case
EPA is writing a policy to allow Bush appointees to referee
By JOHN HEILPRIN
WASHINGTON - In setting limits on chemicals in food and water,
the Environmental Protection Agency may rely on industry tests that
expose people to poisons and raise ethical questions.
The new policy, which the EPA is still developing, would allow
Bush administration political appointees to referee any ethical
disputes. Agency officials are putting the finishing touches on a
plan to take a case-by-case approach.
"It says we're going to look at each study on its individual
terms and accept studies unless they are fundamentally unethical or
have significant deficiencies," said Bill Jordan, a senior policy
adviser in the EPA's Office of Pesticide Programs. "We're setting
the stage for making decisions about these studies. No guarantees
that we will accept the data, and no guarantees that we will reject
the data, either."
He added: "The system is for each program office to look at a
study, and if there's any reason for concern, to bring it to the
highest levels in our agency. If we need to, we'll go to outside
peer reviewers, bioethicists."
Rule likely by 2006
Pesticide makers say human tests give
more-accurate results about the risks of the products to people and
the environment and that they follow safety guidelines set by
Congress, the EPA, courts and scientific groups.
A Nov. 3 draft of the plan, obtained by Public Employees for
Environmental Responsibility, says that anyone affected "should not
assume that EPA will follow a prescribed method of reviewing a
particular human study in each and every instance."
"This is a case-by-case process. As such, it binds no one to a
particular result," says the draft obtained by the whistleblowers'
The draft has undergone several rewrites since then, but there
have not been any substantial changes, Jordan said. A final notice
will probably be published this month and a new rule on
human-testing data issued by 2006, he said.
Critics say that with the draft plan, the EPA is shirking its
duties to set rules now.
"By this sleazy move, EPA defers developing enforceable ethical
standards," said Jeff Ruch, PEER's executive director.
The new policy would probably first be applied to pesticides such
as aldicarb, carbofuran, DDVP and malathion, Jordan said.
Experiments using human subjects submitted by pesticide and other
chemical makers have been a growing source of controversy at the
agency. Jordan said the agency has not relied on any industry data
in setting limits on pesticides or other chemicals since the late
Official's duties may widen
However, "all the studies do
wind up in EPA's hands," whether they are relied on in the
decision-making or not, he said. The EPA also conducts its own
scientific research involving people.
In February 2004, the National Academy of Sciences recommended
that the EPA establish a human-studies review panel to look at all
such studies, both at the start and at the end.
Instead of creating a review panel, the EPA plans to expand the
duties of the director of its National Center for Environmental
Assessment and provide the center with more resources. "We think
it's consistent with the spirit of the NAS report," Jordan said.
In June 2003, the EPA was told that until it issues new rules, it
cannot refuse to consider industry tests involving people on a
case-by-base basis. The order from the U.S. Court of Appeals for the
District of Columbia was the result of a lawsuit by the pesticide
'A bad idea'
Just a month before the court ruling, the EPA
announced it would begin establishing new rules — but then didn't
The EPA briefly stopped accepting industry data from experiments
on humans near the end of the Clinton administration. After
President Bush took office, EPA documents showed that agency
officials had resumed considering data from industry tests on
Jordan said that policy change never took off.
"Folks said that was a bad idea, and we fairly backed off that,"
he said. "We have not issued any risk assessments or made any
regulatory decisions to approve pesticides where we have used human