November 17, 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:

"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 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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