EPA TO ALLOW TESTING ON ORPHANS & HANDICAPPED CHILDREN

POSTED BY: Storymark
UPDATED: Monday, December 5, 2005 17:51
VIEWED: 5031
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STORYMARK

Thursday, December 1, 2005 6:12 PM

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, without exception. But the EPA's newly proposed rule, is ridden with exceptions where chemical studies may be performed on children in certain situations like the following:

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.

Full article at http://www.organicconsumers.org/epa6.cfm

"Well, my days of not taking you seriously are certainly coming to a middle."

JOSSISAGOD

Thursday, December 1, 2005 11:21 PM

Part of me thinks the article's Bulls**t, and another part of me thinks, IF this article is real, then, the peson who wrote it either doesn't have all the information written on the webpage, OR the EPA has degenerated into a bunch of sickos!

SIGNYM

Friday, December 2, 2005 12:52 AM

Well... yes, and no, and yes, and no...

The article is real. The proposed EPA regulation is posted in the Federal Register for comment (deadline Dec 15 2005). http://www.epa.gov/fedrgstr/EPA-GENERAL/2005/September/Day-12/g18010.h
tm

Scanning over the proposed regulation there is both more, and less, to the article than the organiconsumers website would have you believe. The EPA regulation proposes to prohibit all first- and second-party intentional pesticide dosing experiments performed on ANY pregnant women, fetuses of unknown viability, and children and to reject all data submitted by third parties based on those experiments.

The exemption from "informed consent" cited by organic consumers applies to:

Quote:
children as subjects of other than intentional dosing research.

This "other research" is typically observational: lifestyle studies, blood and urine samples, exposure estimates, neuropsych testing etc. There is the ethical question of how long you may observe a hazard w/o intervening, but no none is talking about deliberately exposing children - orphaned, mentally challenged, or not- to chemicals.

But there are other exceptions that are problematic in the regulation:

Quote:
Finally, 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 Sec. 26.221 or Sec. 26.421--i.e., an intentional dosing study involving pregnant women or children as subjects--were found to be crucial to the protection of public health.

Using data from "ethically challenged" studies is like admitting tainted evidence in court... it just encourages more suspect studies. Normally, the big bucks (the pesticide industry in this case, but it could be pharmas or ANY large industry) are the ones doing the studies. As the pharma industry has demonstrated, industry studies are often suspect because unfavorable results or even whole studies are simply eliminated from the report. If the industry thought it could sway regulations by performing unethical studies... which would then be considered by the EPA... they would do it.

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Please don't think they give a shit.

DREAMTROVE

Friday, December 2, 2005 4:47 AM

The EPA is a captured agency, ie. it is controlled by those it seeks to regulate. It stands to reason that anything they would create as a regulation would contain the exemptions asked for by the controlling parties.

SIGNYM

Friday, December 2, 2005 4:52 PM

Please read the PEER (Public Employees for Environmental Responsibility) comments here:

www.peer.org/docs/epa/05_23_11_peer_comments.pdf

The proposed ethical standards came about as a result of a proposed human exposure study (CHEERS) in which poor parents in FLA were paid to spray pesticides in their childrens' rooms. The EPA- which had received $12 million from the chemical industry for the study- at first defended the study, then w/drew it, then calimed that ethical standards for human testing could not be written. It wasn't until Congress passed a law requiring ethical standards that the EPA finally wrote them.

The standards- which have been characterized as "grudging" by PEER- have a number of loopholes:

It only covers pesticide exposure. However, there are non-pesticide toxins to worry about as well.

It accepts third-party unethical data on a case-by-case basis.

It does not prohibit economic inducement (such as in the CHEERS study) used to
"encourage" "informed consent"

Please read the comments in detail.

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Please don't think they give a shit.

DREAMTROVE

Friday, December 2, 2005 11:13 PM

Not surprising that it would have loopholes, say such as ones you could drive a truck through. That's what captured agencies do, they make laws that look good to the layfolk but don't prevent the unethical behavior of their controllers, the capturers.

PSOLARIS

Saturday, December 3, 2005 12:19 AM

I used to work in Medical Research, and this is absolutely shocking to me. When I first started at the research facility, I was lectured on the Declaration of Helsinki which was created to prohibit medical testing to be done on unsuspecting subjects and subjects that are considered high risk (low income societies, convicts in jails, etc.). The declaration is something that everyone in the entire globe has to abide by...or so I was taught. I even had to take a test on the Declaration for FDA purposes and compliance reasons. I've read through the articles here and this sickens me.

Am I missing something? (and if I did, please tell me...because I hope this isn't true).

Psolaris

Ten percent of nuthin' is...let me do the math here...nuthin' into nuthin'...carry the nuthin'

CAUSAL

Saturday, December 3, 2005 1:02 AM

Quote:
Originally posted by SignyM:
Scanning over the proposed regulation there is both more, and less, to the article than the organiconsumers website would have you believe.

[[]sarcasm][]
What? A environmentalist organization making sensationalist claims? How can it be??
[][/sarcasm[]]

________________________________________________________________________
I wish I had a magical wish-granting plank.

SIGNYM

Saturday, December 3, 2005 2:08 AM

Oh, you know- "sexed up". But there really are some terrible flaws in the proposed regulation that wouldn't be easily understood in a quick read.

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Please don't think they give a shit.

DREAMTROVE

Saturday, December 3, 2005 2:22 AM

Psolaris,

I think the study specified that these were NOT unsuspecting subjects, that they had signed, and clearly in the case of pesticide in kids rooms the parents must have had some legal goop authority.

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