Two More Articles on EPA Plans to Test Pesticides on Kids

From: The Scientist

http://www.the-scientist.com/news/display/23007/
By Anne Harding

EPA decision on human testing expected soon
Some agency scientists say loopholes in drafted law would allow unethical
pesticide studies

[Published 24th January 2006 05:35 PM GMT]

The initial draft of the Environmental Protection Agency's first-ever rule
on human testing of pesticides has drawn sharp criticism from public
interest groups, members of Congress, and scientists within the agency
itself, who argue that the law would not protect vulnerable groups.

The rule "looks like it was written by the American Chemical Council," Jeff
Ruch, executive director of Public Employees for Environmental
Responsibility, told The Scientist.

The EPA issued the 30-page draft last September after Congress suspended
human testing of pesticides in August, until appropriate legislation was in
place to protect test subjects. The final version of the rule is due by the
end of this month.

Ruch and other critics say the draft leaves the door open to unethical
conduct. "I am somewhat dismayed that this rule was presented in such a
complex -- and I would have to say, tricky -- way," said Suzanne Wuerthele,
a regional toxicologist for the EPA. Wuerthele belongs to the American
Federation of Government Employees (AFGE), the union representing EPA
scientists, which stated in a December letter to EPA chief Stephen Johnson
that the law "could create serious ethical and liability problems" for its
members.

For instance, the draft waives consent requirements for research in
vulnerable children. It states that researchers don't need consent for
populations for whom "parental or guardian permission is not a reasonable
requirement to protect the subjects (for example, neglected or abused
children)," as long as "an appropriate mechanism for protecting the children
who will participate as subjects in the research is substituted."

The draft law also notes that the EPA could accept data from "ethically
deficient" research conducted before the new law takes effect if it is
deemed necessary to "protect public health." However, the draft does not
define "public health," and some critics have warned that it could be
interpreted extremely loosely. The new draft also defers proposing rules
"providing additional protection for prisoners."

Also, Ruch points out, the law only covers intentional dosing studies, so
that studies like the Children¹s Health Environmental Exposure Research
Study­ in which researchers would have paid parents to spray pesticides near
their children¹s beds, funded by $7 million from EPA and $2 million from the
chemical industry ­ would still be permitted. The study raised outrage last
year and led Democratic lawmakers to threaten to derail Johnson¹s
confirmation as EPA head if it was not cancelled. EPA had argued that the
study was ethical because the parents claimed they would have been using the
pesticides anyway.

The proposed rule ³appears to be an attempt to rationalize old studies that
have a number of ethical problems and rationalize their use to expanding
markets for pesticides,² said Dave Christenson, president of the Denver
AFGE.

Wuerthele noted that the draft rule also does not address the scientific
validity of human tests, going against the recommendations of the National
Academy of Sciences, presented in a 2004 report. ³If a study¹s not
scientifically valid, by definition it is unethical, because it is merely
toying with the subjects, ² Wuerthele said.

For industry, the issue at the heart of the new rule is whether human tests
that have already been performed can be used to re-register pesticides,
according to Mark Maier, health science and policy leader for pesticide
industry group CropLife America. Under the Food Quality Protection Act
(FQPA), all pesticides must be re-registered using current standards by
August 2006, or their registration will be cancelled.

The FQPA has made human testing more attractive to the pesticide industry,
according to critics humans allows manufacturers to sidestep the 10-fold safety requirement the
act demands for animal toxicity tests. But Maier points to a 2001 study that
found human tests result in less stringent requirements just two-thirds of the time.

³Neither EPA or CropLife members have any intention under any circumstances
of testing someone that cannot give consent,² Maier added.

An EPA spokesperson deferred requests for comment until the new rule is
released, and declined to comment on criticisms of the draft.

Anne Harding
Anne_harding@yahoo.com

Links within this article

Public Employees for Environmental Responsibility
http://www.peer.org/

"Protection for Human Test Subjects"
http://www.epa.gov/oppfead1/guidance/human-test.htm

H. Kamenetsky, ³Human data debate,² The Scientist, January 10, 2003.
http://www.the-scientist.com/article/display/21002/

American Federation of Government Employees
http://www.afge.org/Index.cfm

Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and
Ethical Issues
http://www.nap.edu/books/0309091721/html

CropLife America
http://www.croplifeamerica.org/

Dourson et al: "Using Human Data to Protect the Public's Health," Regul
Toxicol Pharmacol, April 2001
PM_ID: 11350206
____________________________________________________________________________
Posted 1/23/2006 9:27 PM
EPA to accept pesticide tests on humans
http://www.usatoday.com/tech/science/2006-01-23-human-testing_x.htm

By John Heilprin, Associated Press Writer
WASHINGTON < The Environmental Protection Agency for the first time is
establishing criteria for tests by pesticide makers on human subjects.
A plane sprays almond groves in California's Central Valley, the nation's
most productive farmland.

By Jack Gruber, USA TODAY staff

Susan Hazen, the EPA's principal deputy assistant administrator for the
Office of Prevention, Pesticides and Toxic Substances, said Monday the new
rule for accepting tests won't allow "intentional pesticide dosing studies
of children and pregnant women."

Last year, President Bush signed a ban on the use of human pesticide test
data until the EPA created regulations for accepting them. The agency also
was required to ban the use of pregnant women and children as subjects, and
to incorporate ethical guidelines from the National Academy of Sciences and
the post-World War II Nuremberg Code.

"We have met and exceeded Congress' direction," Hazen said Monday.
A copy of the EPA's final draft, prepared within the past two weeks, was
reviewed by The Associated Press.

Three California Democrats, Sen. Barbara Boxer and Reps. Henry Waxman and
Hilda Solis, denounced the new rule after obtaining a copy of the final
draft. They had led the effort in Congress to require that the EPA outlaw
the use of pregnant women and children as subjects and that it meet high
ethical standards.

"The fact that EPA allows pesticide testing of any kind on the most
vulnerable, including abused and neglected children, is simply astonishing,"
Boxer said.

She said the EPA rule is inconsistent with what Congress ordered. She said
manufacturers could still conduct testing on pregnant women and children as
long as they could convince the EPA that the researchers didn't intend to
submit the results to the agency at the outset of the study.

Hazen said, however, that the only exception to the ban on accepting data,
including that from pregnant women and children, involves cases in which the
EPA becomes aware that it might need to take additional measures to protect
public health.

However, she noted, "No pesticide company in the U.S. or in most countries
would invest money in developing data to try and prove that EPA should
regulate them more stringently."

The EPA expects a substantial increase in the number of tests it receives
involving intentional exposure of humans to pesticides. The draft final rule
said the agency anticipates receiving 33 such reports a year.

In the last 10 years, only about 20 such studies have been submitted to the
EPA, the agency says. Hazen, however, said those studies include ones from
the 1940s to recent years.

The new criteria for accepting the tests come after a long fight.
Toward the end of the Clinton administration, the EPA briefly stopped
accepting industry data from pesticide experiments on humans. But the agency
resumed considering that data after Bush took office in January 2001.

Then, in a lawsuit brought by the pesticide industry, the U.S. Court of
Appeals for the District of Columbia ruled in 2003 that the EPA cannot
refuse to consider data from manufacturer-sponsored human exposure tests
until it develops regulations on them.

Agency officials said last November that in the meantime it would consider
each study on a case-by-case basis. But Congress stepped in last year to
impose a moratorium after Boxer and Sen. Bill Nelson, D-Fla., demanded that
the EPA cancel an industry-backed pesticide study in which the families of
60 children in Duval County, Fla., would receive children's clothes, a
camcorder and $970 for participating.

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