Public Comment Period Closes

December 12, 2005

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:

1. 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.

2. Parental consent forms are not necessary for testing on children who have been neglected or abused.

3. 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



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