Proposal on human experimentation raises ethical concerns, agency employees say
By Andrew Schneider
Baltimore Sun reporter
December 8, 2005
The union representing scientists at the Environmental Protection Agency added its voice yesterday to critics who are protesting the agency’s proposed rule for human experimentation in testing pesticides.
The rule, which Congress ordered the agency to develop earlier this year, has been criticized by several members of Congress and some EPA personnel as allowing unethical experimentation and failing to protect children and pregnant women.
The American Federation of Government Employees, in a letter sent last night to EPA Administrator Stephen L. Johnson, said it is “extremely concerned that the proposed rule has so many loopholes and exceptions to provide any sort of enforceable ethical standards for … human studies.”
The union said that if the rule is put into effect as proposed, it could create “serious ethical and liability problems” for EPA employees.
The EPA insists that the language in the new rule is completely protective and permits only ethical actions.
“EPA has repeatedly insisted that the proposal provides for rigorous protections, and only studies that meet rigorous scientific and ethical standards will be permitted,” said Eryn Witcher, the EPA’s press secretary. She added that all completed studies will be reviewed “to ensure they meet all the new ethical protections.”
Many of the agency’s toxicologists, scientists and health experts vehemently disagree.
“My people feel very strongly about this,” said Dave Christenson, a member of the union’s national council and president of its Denver-based local. “The main reason that most people came to EPA was because we wanted to protect public health. This rule is really undercutting what EPA is supposed to stand for.”
Sen. Barbara Boxer, a California Democrat who is leading the fight against the rule, said it would allow the EPA to consider unethical tests on pregnant women, infants and children.
“Rather than serving the interests of the pesticide industry, EPA should heed the advice of these dedicated public servants and scrap this deeply flawed approach,” Boxer said in a statement last night.
The period during which the public can comment on the planned rule ends next week. The deadline for issuing the final rule is the end of January 2006.
As proposed, the rule would govern all pesticide studies done by the EPA, funded by the agency or conducted by industry and submitted for EPA consideration in deciding whether to license or register a pesticide for specific uses.
“The pesticide companies want to use this data and be able to sell their pesticides for a whole slew of uses that they’re restricted from now, but their track records of ethical violations in what they submit is alarming,” said Christenson.
Christenson and other critics say that the portions of the proposed rules that concern them include:
The inability of EPA scientists to ensure that industry followed ethical guidelines, such as informing test subjects of the potential hazard from the poisons to which they’re being exposed.
The lack of a firm ban on the use of prisoners as test subjects.
Provisions that would let rules forbidding testing of infants, children and pregnant women to be set aside on the decision of the EPA administrator.
“Also of concern is that the rule would allow 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,” said Charles Orzehoskie, president of the union’s national council of EPA locals.
Interviews with more than a dozen EPA scientists from offices across the country found none who objected to all human testing, only to testing that failed to follow ethical guidelines.
The EPA employees, who asked not to be identified for fear of retaliation, all said they feared they were going to be caught in the middle by the ethical loopholes.
“If this rule is adopted as written, our people will either have to stand up for what’s ethical and proper and face possible disciplinary action or do what their manager will direct them to use … regardless of the ethical problems,” he said. “Our scientists should never have to face this kind of moral dilemma.”
Christenson also said that “in order to give our scientists the protection they need, all the ethical loopholes in the proposed rule must be removed.”
He added that “strong, consistent ethical rules must apply to all EPA programs involved with human-subject research, not just pesticides. Without this, there is no protection.”