EPA decision on human testing expected soon
Some agency scientists say loopholes in drafted law would allow unethical pesticide studies
The initial draft of the Environmental Protection Agency?s first-ever rule on human testing of pesticides has drawn sharp criticism from public interest groups, members of Congress, and scientists within the agency itself, who argue that the law would not protect vulnerable groups.
The rule ?looks like it was written by the American Chemical Council,? Jeff Ruch, executive director of Public Employees for Environmental Responsibility
, told The Scientist
The EPA issued the 30-page draft
last September after Congress suspended human testing of pesticides
in August, until appropriate legislation was in place to protect test subjects. The final version of the rule is due by the end of this month.
Ruch and other critics say the draft leaves the door open to unethical conduct. ?I am somewhat dismayed that this rule was presented in such a complex -- and I would have to say, tricky -- way,? said Suzanne Wuerthele, a regional toxicologist for the EPA. Wuerthele belongs to the American Federation of Government Employees
(AFGE), the union representing EPA scientists, which stated in a December letter to EPA chief Stephen Johnson that the law ?could create serious ethical and liability problems? for its members.
For instance, the draft waives consent requirements for research in vulnerable children. It states that researchers don?t need consent for populations for whom ?parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children),? as long as ?an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted.?
The draft law also notes that the EPA could accept data from ?ethically deficient? research conducted before the new law takes effect if it is deemed necessary to ?protect public health.? However, the draft does not define ?public health,? and some critics have warned that it could be interpreted extremely loosely. The new draft also defers proposing rules ?providing additional protection for prisoners.?
Also, Ruch points out, the law only covers intentional dosing studies, so that studies like the Children?s Health Environmental Exposure Research Study? in which researchers would have paid parents to spray pesticides near their children?s beds, funded by $7 million from EPA and $2 million from the chemical industry ? would still be permitted. The study raised outrage last year and led Democratic lawmakers to threaten to derail Johnson?s confirmation as EPA head if it was not cancelled. EPA had argued that the study was ethical because the parents claimed they would have been using the pesticides anyway.
The proposed rule ?appears to be an attempt to rationalize old studies that have a number of ethical problems and rationalize their use to expanding markets for pesticides,? said Dave Christenson, president of the Denver AFGE.
Wuerthele noted that the draft rule also does not address the scientific validity of human tests, going against the recommendations of the National Academy of Sciences, presented in a 2004 report
. ?If a study?s not scientifically valid, by definition it is unethical, because it is merely toying with the subjects, ? Wuerthele said.
For industry, the issue at the heart of the new rule is whether human tests that have already been performed can be used to re-register pesticides, according to Mark Maier, health science and policy leader for pesticide industry group CropLife America
. Under the Food Quality Protection Act (FQPA), all pesticides must be re-registered using current standards by August 2006, or their registration will be cancelled.
The FQPA has made human testing more attractive to the pesticide industry, according to critics?and the NAS, in its 2004 report--because testing on humans allows manufacturers to sidestep the 10-fold safety requirement the act demands for animal toxicity tests. But Maier points to a 2001 study
that found human tests result in less stringent requirements just two-thirds of the time.
?Neither EPA or CropLife members have any intention under any circumstances of testing someone that cannot give consent,? Maier added.
An EPA spokesperson deferred requests for comment until the new rule is released, and declined to comment on criticisms of the draft.
Links within this article
Public Employees for Environmental Responsibility
?Protection for Human Test Subjects?
H. Kamenetsky, ?Human data debate,? The Scientist, January 10, 2003.
American Federation of Government Employees
Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues
Dourson et al: ?Using Human Data to Protect the Public?s Health,? Regul Toxicol Pharmacol, April 2001