Safety of EPA's human chemical exposure tests in question
The US Environmental Protection Agency (EPA) has announced the closure of public comment on its "no safeguards" policy of accepting all human subject experiments submitted by industry, according to a filing this week by Public Employees for Environmental Responsibility (PEER).This decision comes weeks after the agency was forced to pull the plug on the controversial Children's Environmental Exposure Research Study (CHEERS), where potentially harmful chemicals were sprayed near infants to test the effects on their health (see related story).
Under the new EPA policy, all human chemical dosing studies would be accepted, "unless there is clear evidence that the conduct of these studies was fundamentally unethical& or was significantly deficient relative to the ethical standards prevailing at the time the study was conducted."
However, industry is not required to disclose the conditions under which experiments are conducted, so PEER has expressed its concern that it is not clear how the agency would ever learn of "fundamentally unethical" practices.
The organisation also claims that the EPA is unwilling to define what ethical lapses would disqualify an industry submission from being used for regulatory purposes.
"The Bush Administration is setting the ethical bar so low that only the most sleazy cannot limbo underneath it," PEER programme director Rebecca Roose commented. "The basic problem is this: the safeguards that apply to experiments involving development of drugs to help people are far more stringent than EPA's standards for experiments to determine how much commercial poisons harm people."
She added that the EPA's refusal to adopt basic safeguards requiring proof of informed consent, independent review or protections for children is part of a Bush Administration drive to liberalise rules on the human testing of pesticides and other chemicals.
Without actual human experimental data to justify higher chemical exposures for children, the industry has to abide by the 1996 amendments to the Federal Food, Drug and Cosmetic Act, which sets exposure standards that are ten times stricter for children.
The EPA is also currently conducting over 250 other human experiments, which will serve as a template for the chemical industry to follow. These include:
"The need for safeguards is particularly acute because the EPA is giving industry an economic incentive to push the edge of the ethical envelope," Ms Roose continued. "It is distressing that a federal agency is using tax dollars to write a primer for commercial exploitation of human subjects."
By Jane Kettle