WASHINGTON, DC, February 8, 2005 (ENS): Experiments that intentionally
dose human subjects with pesticides and other chemicals
will be evaluated and approved by the U.S. Environmental
Protection Agency (EPA) in a wide open case-by-case
manner, the agency says in a draft notice for publication
in the Federal Register.
The EPA is seeking public comment on this case-by-case
method of considering experiments that involve human
subjects in a notice dated February 2 and signed by
Susan Hazen, acting assistant administrator in the Office
of Prevention, Pesticides and Toxic Substances.
The guidelines proposed by the agency are all voluntary
and non-binding upon the experimenters, the EPA or the
The notice defers adopting legally binding protections
for infants, fetuses, pregnant women, and prisoners
that apply to all medical and drug testing overseen
by the Department of Health and Human Services (HHS).
Instead, EPA announces that it "indends to publish
a proposed rule” at some time in the future.
The EPA says it "may propose to adopt some or all
of the HHS regulations that provide additional protections
for certain populations of vulnerable subjects."
This proposal "may" require a sponsor or investigator
to provide the protocol for the human studies to the
EPA for prior review and approval.
In the notice, the EPA says its overall goals are,
"That human participants in any research required
by, conducted for, or considered by EPA are treated
ethically; and that all scientifically sound data relevant
to EPA decision-making is considered and used appropriately
in reaching decisions under our authorities."
But the attorney who heads a national association of
natural resources government employees says the agency’s
procedure lacks ethical or safety guidelines. “EPA’s
stance is appallingly amoral," said Jeff Ruch,
executive director of Public Employees for Environmental
Responsibility (PEER), which made the notice public
“At the request of chemical companies seeking
to justify higher exposure limits, EPA will sanction
dosing of infants, pregnant women and other vulnerable
persons with commercial poisons,” Ruch said.
After a heated public debate about intentional dosing
human toxicity studies with pesticides and several attempts
at rulemaking, one of which ended in a 2003 court ruling
that sent the agency back to the drawing board, the
EPA is using this Federal Register notice to outline
the case-by-case procedure it is now using to evaluate
The agency says that any research on human subjects
conducted or supported by the EPA is subject to the
principles of the 1979 Belmont Report, known as the
These principles include such basics as informed consent
about the research procedure, purposes, risks and anticipated
benefits, and a statement offering the subject the opportunity
to ask questions and to withdraw at any time from the
But third party studies, conducted by groups not supported
by federal money, are not subject to the Common Rule.
The agency says it will continue to accept scientifically
valid third party studies unless there is "clear
evidence" that the studies were "fundamentally"
unethical, that is, "the studies were intended
to seriously harm participants or failed to obtain informed
The agency said it intends to expand the functions
of the EPA Human Subjects Research Review Official (HSRRO).
This official has responsibility for assuring that all
human subjects research conducted or supported by the
EPA complies with the requirements of the Common Rule.
Ruch says by giving the HSRRO this responsibility,
the EPA avoids "any requirement of an independent
safety or ethical review, as is required for all other
government human subject studies."
The agency will not require that companies demonstrate
that they have abided by informed consent, appropriate
inducement and other basic ethical standards.
Instead, the EPA says it will at some future time,
"develop and make public a policy statement that
encourages, but does not require," non-federal
researchers planning studies involving human participants
to support an EPA regulatory decision, to submit a proposed
protocol to EPA prior to conducting the research.
Also the EPA intends to publish a "non-binding
guidance" explaining that the agency expects compliance
with the Common Rule for any future human studies specifically
required by the EPA.
The EPA says it intends to reach out to scientific
journals encouraging improved reporting of the ethics
of published human studies.
The EPA case-by-case process allows wide latitude to
scientists and chemical companies. Any "stakeholder"
may urge EPA to: "(1) Conclude that this process
is inapplicable; (2) consider factors other than those
described here; or (3) make an exception to the process
EPA notes that based on individual circumstances it
may decide to act differently from the review process
described in the Federal Register notice. "Affected
parties should not assume that EPA will follow a prescribed
method of reviewing a particular human study in each
and every instance," the agency writes.
The only requirement the agency says it will adhere
to is that in any action involving consideration and
review of a third-party, intentional dosing human study,
EPA "will explicitly state the basis upon which
such a study has been evaluated."
“Since there are no public notice requirements,"
Ruch said, "the outside world will never learn
of ethically dubious corporate experiments."
He warned that many corporate studies will be done
in developing countries, inviting "chemical companies
to push the outside of the moral envelope.”
Last November the EPA delayed its own controversial
Children's Health Environmental Exposure Risk Study
(CHEERS) which would measure children's exposure to
pesticides in the home, to calm public concern generated
by news reports questioning whether the study conforms
to ethical standards.
The EPA would pay 60 families nearly $1,000 each for
involvement in the two-year study.
Critics such as the Environmental Working Group and
PEER say collecting such human testing data unethically
encourages study participants to be exposed to toxic
substances to allow industry to push for reduced regulatory
controls on pesticides and other chemicals.
The EPA is forming a panel to review the study. In
a January 24 letter to then EPA Deputy Administrator
Stephen Johnson, the Environmental Working Group requests
that the makeup of the panel be "fair and balanced."
"By that we mean that there should be no past
or present pesticide or chemical industry employees,
consultants or contractors on the review panel, and
that there must be several individuals with strong public
health credentials, including expertise in pediatric
environmental health," wrote Environmental Working
Group Senior Vice President Richard Wiles.
Johnson, who has defended the CHEERS study, has now
been elevated to the position of EPA Acting Administrator,
following the departure of former EPA Adminstrator Mike
Leavitt January 28 to head the Department of Health
and Human Services.
Wiles notes that his organization and others object
to the "fundamentally unethical nature" of
the CHEERS study design, which proposed to "stand
by and simply observe what the study acknowledged to
be high pesticide exposures to infants and small children."
The federal register notice, with its wide open non-binding
guidelines appears to be the agency's attempt to lay
the groundwork for justifying consideration of such
This draft notice is identical to an earlier draft
of the EPA's approach to human testing of chemical exposures.
The first draft was withdrawn after PEER publicly released
it in late November. Ruch says this latest draft is
"identical in effect to the earlier draft"
but specifies possible standards that EPA may consider
in the future.
Pesticide makers, who support human testing data as
more reliable than animal studies in developing accurate
exposure limits, have been awaiting a rule for years.
Copyright Environment News Service (ENS) 2004. All