Richard Moore



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 ---

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

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


"Apocalypse Now and the Brave New World"

Posting archives:

Subscribe to low-traffic list:
In accordance with Title 17 U.S.C. Section 107, this material
is distributed without profit to those who have expressed a
prior interest in receiving the included information for
research and educational purposes.