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Washington, DC — The U.S. Environmental Protection Agency has submitted
a very limited proposal to protect human subjects used in toxic chemical experiments,
according to an internal draft released today by Public Employees for Environmental
Responsibility (PEER). EPA is under orders from Congress to promulgate ethical
standards as a condition for lifting a moratorium on human dosing studies.

The proposed rules submitted by EPA to the President’s Office of Management
& Budget for a final review before publication in the Federal Register are
a mixed bag of protections and loopholes. For the first time, EPA would set
some ethical standards for experiments conducted by industry. EPA would also
finally adopt minimal protections for experiments on children, fetuses and pregnant

More significantly, however, EPA would not prohibit –

  • Tests exposing human subjects to toxic chemicals where the main purpose
    is to measure levels of exposure, absorption or metabolism of the chemical
    apart from its toxic effects on the subject;
  • Use of earlier studies that do not meet current ethical standards. These
    older experiments will be evaluated according to the “ethical standards
    prevailing at the time” the test was conducted; and
  • Tests using undue financial inducements to subjects of limited economic
    means or prisoners.

In addition, EPA would apply protections only in research where subjects are
intentionally dosed with pesticides. In the highly controversial CHEERS study,
since abandoned by EPA under congressional pressure, EPA planned to pay parents
to allow monitoring of infants under age 3 after the parents sprayed pesticides
in the rooms primarily occupied by the baby. EPA contends that CHEERS is not
an intentional dosing experiment because the parents were voluntarily applying
pesticides in the home.

“While it is gratifying that EPA is at last acknowledging the need for
ethical standards to govern human testing it is disheartening that the agency
has such a stingy and narrow view of its moral obligations,” stated PEER
Program Director Rebecca Roose, noting that the principal purposes of the studies
will be to justify relaxing pesticide exposure limits. “EPA’s proposal
is filled with weasel words and slippery distinctions that will lead to its
exceptions swallowing the rule.”

For the past several months, EPA had been aggressively advocating an open-door
policy on human testing without standards, except as determined by top agency
managers on a “case-by-case” basis. Growing concern about questionable
practices in EPA-funded studies and the absence of any meaningful review led
Congress, in the agency’s appropriations bill for the coming fiscal year,
to order promulgation of rules. Once published in the Federal Register, the
proposed rules would be subject to a 90-day comment period.

“EPA’s priority is to make the pesticide industry happy and to
ensure that ethical considerations do not interfere with business as usual,”
Roose added.


Read the Proposed Rule on Protections for Test Subjects in Human
(Available upon request)

more about CHEERS and human testing at EPA

Phone: 202-265-7337

962 Wayne Avenue, Suite 610
Silver Spring, MD 20910-4453

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Environmental Responsibility

PEER is a 501(c)(3) organization
EIN: 93-1102740