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nosmokes Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Dec-09-05 04:55 PM
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Scientists union opposes EPA's pesticide-test plan
original


Scientists union opposes EPA's pesticide-test plan



Proposal on human experimentation raises ethical concerns, agency employees say

BaltimoreSun.com



By Andrew Schneider
Baltimore Sun
December 7, 2005

The union representing scientists at the Environmental Protection Agency added its voice Wednesday to critics who are protesting the agency's proposed rule for human experimentation in testing pesticides.

The rule, which Congress ordered the agency to develop earlier this year, has been criticized by several members of Congress and some EPA personnel as allowing unethical ex perimentation and failing to protect children and pregnant women.

The American Federation of Government Employees, in a letter sent Wednesday night to EPA Administrator Stephen L. Johnson, said it is "extremely concerned that the proposed rule has so many loopholes and exceptions to provide any sort of enforceable ethical standards for human studies."

The union said that if the rule is put into effect as proposed, it could create "serious ethi cal and liability problems" for EPA employees.

The EPA insists that the language in the new rule is completely protective and permits only ethical actions.

"EPA has repeatedly insisted that the proposal provides for rigorous protections, and only studies that meet rigorous scientific and ethical standards will be permitted," said Eryn Witcher, the EPA's press secretary. She added that all completed studies will be reviewed "to insure they meet all the new ethical protections."

Many of the agency's toxicologists, scientists and health experts vehemently disagree.
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complete articlehere
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WindRavenX Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Dec-09-05 04:56 PM
Response to Original message
1. No ethical scientist will comply with this test
I hope all moral scientists raise their voices and refuse to take part in this.

Grossly unethical, at the very least, evil at the worst.
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MrMonk Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Dec-09-05 05:05 PM
Response to Reply #1
2. Please describe the test.
I don't see any test plan in the article or in the proposed EPA rules.
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WindRavenX Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Dec-09-05 05:09 PM
Response to Reply #2
3. they will be testing potentially very carcinogenic/neurotoxic chemicals...
Edited on Fri Dec-09-05 05:09 PM by WindRavenX
...on humans, possibly without their consent. That's...just unethical by any standards, but particularly for scientists. The harm to sensitive individuals--like pregnant women--could be quite severe.

This seems like the EPA is trying to have a more toned down version of its original experiment which was to be carried out in poor areas in Florida and other areas of the south, IIRC.

on edit: the test being seeing the effect of said chemicals found in commercial pesticides.
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MrMonk Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Dec-09-05 05:24 PM
Response to Reply #3
4. Then how do you explain Ss. 26.220 and 26.420 in the proposed rules?
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WindRavenX Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Dec-09-05 05:29 PM
Response to Reply #4
5. ach, could you be kind enough to sumerize what those sections say?
I can't find them in the pdf.

This is what concerns me:

* The inability of EPA scientists to ensure that industry followed ethical guidelines, such as informing test subjects of the potential hazard from the poisons to which they're being exposed.
* The lack of a firm ban on the use of prisoners as test subjects.
* Provisions that would let rules forbidding testing of infants, children and pregnant women to be set aside on the decision of the EPA administrator.


Do the sections you posted reply to this? Because the problems I've posted is probably what the scientists object to.

thanks :hi:
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MrMonk Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Dec-09-05 06:38 PM
Response to Reply #5
6. Regarding your concerns . . .
Edited on Fri Dec-09-05 06:51 PM by MrMonk
To the first point, that EPA can't ensure that industry has followed ethical guidelines, I note that, under the existing rule, an industry would have to show that ethical guidelines had been adhered to in order to have its data accepted. There are exceptions to that requirement, based on the benefit to the public of considering such data. The EPA rules don't require that industry submit an investigation plan before conducting tests, and the EPA might not have that authority. I can't find such a requirement in the HHS rules either. On edit: I note that the proposed 26.101(j), (k) states conditions under which a third party must submit their plan before beginning a study, including the ethical guidelines to be followed. The proposed 26.124 requires that third-party adherence to the guidelines must be fully documented to EPA when the study has been completed. That provision could be tightened up to require ongoing documentation rather than only requiring post-study documentation.


The second point is not addressed in the proposed EPA rules. I note that there is already a ban against conducting such research on prisoners under an HHS rule (45 CFR 46.306), and that HHS must be notified of all proposed EPA studies on human subjects. I do not know for certain whether HHS can veto an EPA study, though I expect that consistent application of US laws would require it. I would agree that testing on prisoners should have a specific mention in the EPA rule.


The third point is addressed, in part, by the following paragraphs:

Sec. 26.220 Prohibition of research involving intentional dosing of
pregnant women, fetuses, or newborns.

Notwithstanding any other provision of this part, under no
circumstances shall EPA or a person when covered by Sec. 26.101(j)
conduct or support research involving intentional dosing of any
pregnant woman, fetus, or newborn.

Sec. 26.420 Prohibition of research involving intentional dosing of
children.

Notwithstanding any other provision of this part, under no
circumstances shall EPA or a person when covered by Sec. 26.101(j)
conduct or support research involving intentional dosing of any child.



EPA may accept results from such studies on pregnant women or children under certain conditions, but may not make such studies or support them. Under law, EPA does not have authority to comprehensively prohibit such studies. That doesn't mean that they couldn't be prohibited by some other governmental body.


To look at the existing rules, start here: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1
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WindRavenX Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Dec-09-05 06:48 PM
Response to Reply #6
7. thank you very much
It seems like the language in the sections you posted (again, thank you) revolve around the word "intentional".

Most of the scientists that object to this study feel that people will be "unintentionally" harmed...which is still a source for objection.
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MrMonk Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Dec-09-05 06:53 PM
Response to Reply #7
8. If that were the case
then the appropriate step would be to ban exposure studies, and I don't think that's what the EPA scientists want to happen. Because, then, they would not have the information needed to do their jobs.
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WindRavenX Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Dec-09-05 06:54 PM
Response to Reply #8
9. haha true
I think these studies on exposure are...not kosher. I dislike how they seem to be potentially exposing people to these things.
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