I thought this was so outrageous, it must be a mistake. But its not.
The EPA web site says that the mis-named "Protection for Subjects in Human Research" rulemaking is intended to "ban intentional dosing human testing for pesticides when the subjects are pregnant women or children," "strengthen existing protections for subjects in human research" and to "extend new protections to adult subjects in intentional dosing human studies for pesticides conducted by others who intend to submit the research to EPA."
However, if you read the language, there are many exceptions that actually could allow intentional testing of pesticides on pregnant women, fetuses and children, and make exceptions to parental consent requirements for "abused or neglected" children (why are pesticides being tested on abused and neglected children?!), thereby failing to protect those who are both most vulnerable to pesticide exposure, and least capable of giving consent.
Below I have pasted just a few of the sections of this rule that raise ethical concerns (I added the bold and underlining formatting for emphasis).
The Physicians for Social responsibility web site EnviroHealth Action has information and link for sending a letter to EPA about this rule. http://www.envirohealthaction.org/action/index.asp?step=2&item=2957
Sec. 26.408 Requirements for permission by parents or guardians and
for assent by children.
(a) In addition to the determinations required under other
applicable sections of this subpart, the IRB 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. In determining whether children are capable of assenting, the
IRB shall take into account the ages, maturity, and psychological state
of the children involved. This judgment may be made for all children to
be involved in research under a particular protocol, or for each child,
as the IRB deems appropriate. If the IRB determines that the capability
of some or all of the children is so limited that they cannot
reasonably be consulted or that the intervention or procedure involved
in the research holds out a prospect of direct benefit that is
important to the health or well-being of the children and is available
only in the context of the research, 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 under circumstances in which consent
may be waived in accord with Sec. 26.116(d).
(b) In addition to the determinations required under other
applicable sections of this subpart, the IRB shall determine, in
accordance with and to the extent that consent is required by Sec.
26.116, that adequate provisions are made for soliciting the permission
of each child's parents or guardian. Where parental permission is to be
obtained, the IRB may find that the permission of one parent is
sufficient for research to be conducted under Sec. 26.404 or Sec. 26.405.
(c) In addition to the provisions for waiver contained in Sec.
26.116, 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 in subpart A of this part and paragraph (b) of this
section, provided an appropriate mechanism for protecting the children
who will participate as subjects in the research is substituted, and
provided further that the waiver is not inconsistent with Federal,
State or local law. The choice of an appropriate mechanism would depend
upon the nature and purpose of the activities described in the
protocol, the risk and anticipated benefit to the research subjects,
and their age, maturity, status, and condition. . .
Sec. 26.421 Prohibition of EPA reliance on research involving
intentional dosing of children.
In its regulatory decision-making under the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), EPA shall
not rely on any research involving intentional dosing of any child,
except when such research is deemed scientifically sound and crucial to
the protection of public health, under the procedure defined in Sec.
26.603. . .
Sec. 26.603 Exceptions for human research.
(a) Before reaching a decision not to rely on scientifically useful
and relevant data derived from research that does not meet the
applicable standards of Sec. Sec. 26.601 through 26.602, or that
involves intentional exposure of a pregnant woman, fetus, newborn, or
child, EPA will consider whether the data are crucial to a regulatory
decision that would be more protective of public health than could be
justified without relying on the data.
(b) Before making a decision under this section, EPA will solicit
the views of the Human Studies Review Board and provide an opportunity
for public comment.
(c) If EPA decides to rely on data derived from a study that does
not meet the applicable standards of Sec. Sec. 26.601 through 26.602,
EPA will include in the explanation of its decision a thorough
discussion of the significant ethical deficiencies of the study, as
well as the full rationale for concluding that relying on the study is
crucial to protection of public health.
Kathryn Savoie, Ph.D.
Environmental Program Director
Arab Community Center for Economic and Social Services (ACCESS)
6450 Maple Street
Dearborn MI 48126
From: firstname.lastname@example.org [mailto:email@example.com] On Behalf Of Alex J. Sagady & Associates
Sent: Thursday, November 17, 2005 2:33 AM
Subject: E-M:/ EPA allowance for testing pesticides on children
Enviro-Mich message from "Alex J. Sagady & Associates" <firstname.lastname@example.org>
EPA considering pesticide testing on orphans and
mentally handicapped children under "human subject"
Alex J. Sagady & Associates http://www.sagady.com
Environmental Enforcement, Permit/Technical Review, Public Policy,
Evidence Review and Litigation Investigation on Air, Water and
Waste/Community Environmental and Resource Protection
Prospectus at: http://www.sagady.com/sagady.pdf
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