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I.G. Farben’s Dream


According to an ALERT that was just posted to the Organic Consumers Association‘s website, the U.S. Environmental Protection Agency currently is accepting public comments on a proposed rule change titled “Protections for Subjects in Human Research,” the gist of which, if enacted into law, would “allow government and industry scientists to treat children as human guinea pigs in chemical experiments in the following situations”:

1. Children who “cannot be reasonably consulted,” such as those that are mentally handicapped or orphaned newborns may be tested on. With permission from the institution or guardian in charge of the individual, the child may be exposed to chemicals for the sake of research.
2. Parental consent forms are not necessary for testing on children who have been neglected or abused.
3. Chemical studies on any children outside of the U.S. are acceptable.

Good stewardship, Mr. President? And here I had thought that Super Predator only deployed Zyklon-B-type and related agents against its victims in other countries. Silly me.

The Organic Consumer Association’s post includes a quote from California Representative Henry Waxman, who said in a statement issued in mid-September that the “EPA has proposed a program to allow for the systematic and everyday experimentation of pesticides on humans,” adding that the “proposed program is riddled with ethical loopholes.”

The same Baltimore Sun report that carried the quote from Waxman carried several other good ones as well (“Exceptions in new EPA rules would allow testing pesticides on children,” Andrew Schneider, Sept. 14). Including one from the Natural Resources Defense Council’s Aaron Colangelo, who, doubtless more out of anger and disgust than genuine bewilderment, exclaimed:

The rule says it’s acceptable to test children if there is a direct benefit. How can any child possibly benefit from exposure to pesticides? What was EPA thinking about? This is ethically abhorrent, and the way EPA described this rule is clearly misleading. In fact, the rule expressly approves intentional chemical tests against these [at-risk groups] in several circumstances.

The OCA’s ALERT rightly urges everyone to send a message (letter, email, phone call—or large rock with a note tied to it) to the EPA as part of its regular public-comment period, which is scheduled to close in less than four weeks, on December 12.

But—my god! Surely there must be actions more persuasive than these.

Protections for Subjects in Human Research,” Federal Register, September 12, 2005 (as posted to the U.S. Environmental Protection Agency‘s website)

ALERT: EPA TO ALLOW PESTICIDE TESTING ON ORPHANS & MENTALLY HANDICAPPED CHILDREN, Organic Consumers Association

Many Little Eichmanns, ZNet, February 28, 2005
Aggressive/Antisocial, Drug Addiction, Mental Illness, ZNet, August 15, 2005
Super Predator, ZNet, October 7, 2005

FYA (“For your archives”):

The Baltimore Sun
September 14, 2005 Wednesday
SECTION: TELEGRAPH; Pg. 1A
HEADLINE: Exceptions in new EPA rules would allow testing pesticides on children
BYLINE: Andrew Schneider, SUN NATIONAL STAFF
DATELINE: WASHINGTON

WASHINGTON – The Environmental Protection Agency’s new rules on human testing, which the agency said last week would “categorically” protect children and pregnant women from pesticide testing, include numerous exemptions – including one that specifically allows testing of children who have been “abused and neglected.”

The rules were revised under intense criticism from environmental groups, scientists and members of Congress, after the disclosure that subjects in some earlier pesticide studies were unaware of what they were being exposed to and, in many cases, did not know why the testing was being done.

One study would have used $2 million from the chemical industry to measure the pesticide consumption of infants in low-income households in Florida.

In unveiling the new rules last week, the EPA promised full protection for those most at risk of unethical testing.

“We regard as unethical and would never conduct, support, require or approve any study involving intentional exposure of pregnant women, infants or children to a pesticide,” the rule states.

But within the 30 pages of rules are clear-cut exceptions that permit:

Testing of “abused or neglected” children without permission from parents or guardians.

“Ethically deficient” human research if it is considered crucial to “protect public health.”

More than minimal health risk to a subject if there is a “direct benefit” to the child being tested, and the parents or guardians agree.

EPA acceptance of overseas industry studies, which are often performed in countries that have minimal or no ethical standards for testing, as long as the tests are not done directly for the EPA.

The EPA provided little clarification yesterday in response to questions about the exemptions.

In a written response, officials said that abused and neglected children were specifically singled out to create “additional protection” for them, although they did not elaborate.

And they denied there were any exceptions to the prohibitions on testing women and children. They added that the new rules meet all the requirements set by Congress last spring and summer in a series of often heated hearings.

But some of those who led the hearings disagreed.

“For the first time in our nation’s history, the EPA has proposed a program to allow for the systematic and everyday experimentation of pesticides on humans,” Rep. Henry A. Waxman, a California Democrat and leading critic of the testing policies, said in a statement yesterday. “Moreover, the proposed program is riddled with ethical loopholes.”

Sen. Barbara Boxer, another California Democrat, who also demanded improvements in protecting human test subjects, voiced similar criticism.

“The EPA proposed rule on human testing has several large loopholes that undermine the very purpose of the rule. No wonder the pesticide companies are saying such nice things about it,” Boxer said.

“This is unethical and contrary to recent direction from Congress.”

Many critics believe that the agency is buckling to the pesticide industry, which has faced much more stringent testing standards under regulations approved in 1996.

The exemptions are “obviously driven by the pesticide industry’s goal of relaxing pesticide safety standards,” said Aaron Colangelo, a senior staff lawyer with the Natural Resources Defense Fund, which has been involved in 18 lawsuits against the pesticide industry and government agencies.

Public health experts, including Colangelo, said they had no idea what the EPA meant by some of the language in the exemptions – how the agency might define a “direct benefit” to a child, for example.

“The rule says it’s acceptable to test children if there is a direct benefit,” Colangelo said. “How can any child possibly benefit from exposure to pesticides? What was EPA thinking about?”

“This is ethically abhorrent, and the way EPA described this rule is clearly misleading,” he said. “In fact, the rule expressly approves intentional chemical tests against these [at-risk groups] in several circumstances.”

Richard Wiles, senior vice president of Environmental Working Group, said “EPA’s proposal is the [pesticide] industry’s dream, and the public’s nightmare.”

Physicians and lawyers offered possible explanations for some of the exemptions.

A study that could mean higher crop yields could be justification enough for the EPA to cite a “public health benefit” under the exemptions, said Dr. Alan Lockwood, an expert in human-testing ethics and past president of Physicians for Social Responsibility.

“This would be a public health benefit, even though the exposed children may experience an adverse effect.”

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