[Marxism] Fwd: EPA to Allow Pesticide Testing on Orphans and Mentally Handicapped Children

Louis Proyect lnp3 at panix.com
Fri Nov 18 07:42:34 MST 2005

(From Jim Craven)

>Organic Consumers | November 17, 2005
>Send a letter to EPA here!
>Forward this alert to friends and colleagues
>Public Comment Period Closes
>December 12, 2005
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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 
>(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
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