E-Accountability question: Is America's drug and insurance industries funding the mental health/behavior modification of our nation's youth in order to launder money through clinics and boot camps, and use our ill, orpaned, and/or handicapped children as human guinea pigs?

We need to know.

ALERT: EPA TO ALLOW PESTICIDE TESTING ON ORPHANS & MENTALLY HANDICAPPED CHILDREN

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Public comments are now being accepted by the Environmental Protection Agency (EPA) on its newly proposed federal regulation regarding the testing of chemicals and pesticides on human subjects. On August 2, 2005, Congress had mandated the EPA create a rule that permanently bans chemical testing on pregnant women and children. But the EPA's newly proposed rule, misleadingly titled "Protections for Subjects in Human Research," puts industry profits ahead of children's welfare. The rule allows for government and industry scientists to treat children as human guinea pigs in chemical experiments in the following situations:

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.
Parental consent forms are not necessary for testing on children who have been neglected or abused.
Chemical studies on any children outside of the U.S. are acceptable.

Send a letter to EPA here!

OCA's focal concerns with this proposed rule specifically involve the following portions of text within the EPA document (Read the full EPA proposed rule here: PDF --- HTML):

70 FR 53865 26.408(a) "The IRB (Independent Review Board) shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent...If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement..."

(OCA NOTE: Under this clause, a mentally handicapped child or infant orphan could be tested on without assent. This violates the Nuremberg Code, an international treaty that mandates assent of test subjects is "absolutely essential," and that the test subject must have "legal capacity to give consent" and must be "so situated as to exercise free power of choice." This loophole in the rule must be completely removed.)

70 FR 53865 26.408(c) "If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements..."

(OCA NOTE: Under the general rule, the EPA is saying it's okay to test chemicals on children if their parents or institutional guardians consent to it. This clause says that neglected or abused children have unfit guardians, so no consent would be required to test on those children. This loophole in the rule must be completely removed.)

70 FR 53864 26.401 (a)(2) "To What Do These Regulations Apply? It also includes research conducted or supported by EPA outside the United States, but in appropriate circumstances, the Administrator may, under § 26.101(e), waive the applicability of some or all of the requirements of these regulations for research..."

(OCA NOTE: This clause is stating that the Administrator of the EPA has the power to completely waive regulations on human testing, if the testing is done outside of the U.S. This will allow chemical companies to do human testing in other countries where these types of laws are less strict. This loophole in the rule must be completely removed.)

70 FR 53857 "EPA proposes an extraordinary procedure applicable if scientifically sound but ethically deficient human research is found to be crucial to EPA's fulfilling its mission to protect public health. This procedure would also apply if a scientifically sound study covered by proposed § 26.221 or § 26.421--i.e., an intentional dosing study involving pregnant women or children as subjects..."

(OCA NOTE: This clause allows the EPA to accept or conduct "ethically deficient" studies of chemical tests on humans if the agency deems it necessary to fulfull its mission. Unfortunately, the EPA report sets up no criteria for making such an exception with any particular study. This ambiguity leaves a gaping loophole in the rule. Without specific and detailed criteria, it could be argued that any and every study of chemical testing on humans is "necessary." This loophole in the rule must be removed, based on this inadequacy of criteria and definition.)

Send an email to EPA here!

Forward this alert to friends and colleagues

By mail: Send two copies of your comments to:
Public Information and Records Integrity Branch (PIRIB)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Mail Code: 7502C
1200 Pennsylvania Ave., NW
Washington, DC, 20460-0001
Attention: Docket ID Number OPP-2003-0132

You can learn more and take action

Take action now

San Francisco Chronicle
September 15, 2005
EPA Rule Loopholes Allow Pesticide Testing on Kids
by Andrew Schneider

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, such as 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 often are 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 this week 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.

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

© 2005 San Francisco Chronicle

Exceptions in new EPA rules would allow testing pesticides on children
By Andrew Schneider, Sun National Staff
September 14, 2005

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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."
Copyright © 2005, The Baltimore Sun

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