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
(Available upon request)