February
8, 2005
Environment
News Service (ENS)
EPA Avoids
Regulation of Chemical Experiments on Humans
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 public.
There
are no legally binding regulations on the intentional dosing
of pregnant women with chemicals for experiments.
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 on Monday.
“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 such studies.
Rental
housing for farm workers, Sebring, Florida. Children in homes
like this are proposed by the EPA for an experiment subjecting
them to intentional doses of pesticides.
(Photo courtesy HUD)
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 Common Rule.
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 research.
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 consent ..."
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."
Jeff Ruch,
PEER executive director a founder of the organization, is a
former California deputy district attorney, and former counsel
to California legislative committees. (Photo courtesy PEER)
"In
practice, Ruch says, "it will be up to the top political
appointees to flag unethical corporate experiments on a case-by-case
basis."
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 as described."
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.”
Vietnamese
women and children. Although there has been little study of
whether high levels of insecticides in the environment are causing
disease, insecticide poisoning cases are common in Vietnam's
hospitals, according to a 1996 issue of "Environmental
Health Perspectives," a government publication. (Photo
courtesy EHP)
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.
EPA Acting
Administrator Stephen Johnson (Photo courtesy EPA)
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 human studies.
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
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Environment News Service (ENS) 2004. All Rights Reserved.
