http://www.peer.org/news/news_id.php?row_id=567
August 11, 2005
Public Employees for
Environmental Responsibility (PEER)
Contact: Chas Offutt (202) 265-7337
EPA PROPOSES ONLY HALF-STEPS ON HUMAN
CHEMICAL TESTING — Proposed Rule Riddled With Loopholes;
Would Not Bar Infamous “CHEERS” Study
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 women.
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
Research
(Available upon request)
Learn
more about CHEERS and human testing at EPA
