(Washington)—The American Federation of Government Employees (AFGE) yesterday issued a letter
to Environmental Protection Agency Administrator Stephen Johnson addressing its concerns with a new EPA proposed rule regarding human subject testing.
“AFGE is extremely concerned that the proposed rule has so many loopholes and exceptions to provide any sort of enforceable ethical standards for intentional dosing human studies,” said Charles Orzehoskie, president of AFGE’s National Council of EPA locals, which represents approximately 6,500 EPA employees. “It creates serious ethical and liability problems for EPA employees, and directly conflicts with EPA’s mission to ‘protect human health and the environment.’”
“The proposed rule would only apply to ‘intentional dosing studies’ where the researcher intended to submit the resulting information to EPA. This is of particular concern because it will require EPA scientists to prove that the third party researcher intended to submit the research for regulatory consideration. In other words, EPA scientists might have to accept the data, even if the study had been conducted in an unethical manner. EPA seems to be encouraging non-compliance with its own standard.”
The proposed rule also has far too many exemptions to make it an effective ethical safeguard for human studies, the letter stated, including accepting data from intentional dosing studies done on pregnant women, newborns and fetuses if the data are “crucial to regulatory decisions …” “AFGE believes that under no circumstances should EPA accept data from studies where [such people] have been deliberately exposed to pesticides or other chemicals.”
“Additionally, the rule allows for an agency head to adopt procedural modifications when conducting children’s intentional dosing studies and allows for an EPA administrator to waive some or all of the children’s special protections,” Orzehoskie added. “AFGE firmly believes that any ethical safeguards adopted by EPA should be uniformly enforced, and that the EPA administrator should not be given unilateral authority.
“Of further concern is that the rule allows testing on children who ‘cannot be reasonably consulted,’ such as those that are mentally handicapped; does not require parental consent for testing on children who have been neglected or abused; and accepts studies done on children outside of the United States, which may not comply with EPA standards.”
Read the letter