Despite receiving over 50,000 letters from citizens, Congress, and EPA's own scientists opposing the proposed rule, the EPA has published a new federal regulation that will continue to allow observational studies of chemical and pesticide exposure 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 observational 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 studied. With permission from the institution or guardian in charge of the individual, the child may be studied.
- Parental consent forms are not necessary for studies with children who have been neglected or abused.
- Chemical studies on any children outside of the U.S. are acceptable.
"The fact that EPA allows pesticide testing of any kind on the most vulnerable, including abused and neglected children, is simply astonishing," said Sen. Barbara Boxer, D-Calif. Even EPA's own scientists are speaking out against the agency's proposed rule. "I am somewhat dismayed that this rule was presented in such a complex -- and I would have to say, tricky -- way," said Suzanne Wuerthele, a regional toxicologist for the EPA.
Tell Congress to advise the EPA to strengthen this rule here!
OCA's focal concerns with this proposed rule specifically involve the following portions of text within the EPA document (Note: This is in regards to the proposed rule: PDF --- HTML). The issues below are discussed by the EPA in their final published rule but are not mitigated. See excerpts here. EPA's full final rule is here..
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.)
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
(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.)