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E-M:/ RE: / EPA allowance for testing pesticides on children

Title: RE: / EPA allowance for testing pesticides on children

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

(313) 216-2225


-----Original Message-----
From: owner-enviro-mich@great-lakes.net [mailto:owner-enviro-mich@great-lakes.net] On Behalf Of Alex J. Sagady & Associates
Sent: Thursday, November 17, 2005 2:33 AM
To: enviro-mich@great-lakes.net
Subject: E-M:/ EPA allowance for testing pesticides on children


Enviro-Mich message from "Alex J. Sagady & Associates" <ajs@sagady.com>


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

PO Box 39,  East Lansing, MI  48826-0039 

(517) 332-6971; (517) 332-8987 (fax); ajs@sagady.com



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