Summary

Original source:
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Details

• 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.
• 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.
• (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 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.
• (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.)

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