EWG sent this letter to the NAS Committee co-chair after the group approved the highly controversial procedure of using humans in laboratory tests for pesticides and other chemicals.
February 23, 2004
Michael R. Taylor — Committee Co-chair
Senior Fellow and Director
Risk, Resource, and Environmental Management Division
Resources for the Future
1616 P Street, NW
Washington, DC 20036
I am writing to express the Environmental Working Group's extreme disappointment and concern over a series of glaring omissions in the final report from the Committee on the Use of Third Party Toxicity Research with Human Research Participants. While the committee may have intended to tightly constrain human subject research with pesticides and pollutants, the final report is so riddled with loopholes and blinded by oversights that it is certain that abuses will follow. As just one example, the report provides the rationale, if not a road map, to destroy what little is left of the Food Quality Protection Act's novel approach to safeguarding infants and children from pesticides.
The committee explicitly states that testing of pesticides and pollutants on children is acceptable in limited circumstances. The committee did not, however, say what those limited circumstances are. Instead, committee members stated repeatedly in response to reporter questions that they could not imagine cases where testing on children would be scientifically and ethically justified. That may be true, but it is a grossly insufficient response to a critical question. We are confident that the imaginations of the pesticide and chemical industries will not similarly fail them.
More to the point, if the committee cannot imagine when testing on children would be allowed, it can surely think of some circumstances when it should not be allowed. The committee failed utterly in its duty to the public by not clearly articulating such circumstances, and we request that the committee amend the report to list situations where testing on children should be prohibited.
The most obvious example where testing on children should be banned is pesticides, which are licensed pollutants that are deliberately added to the environment. Pesticides differ fundamentally from other pollutants like ground level ozone or particulate matter that are undesirable by-products of industry and internal combustion engines. The need to clearly prohibit pesticide testing on children is made more urgent by the fact that the law specifically requires protection of the infant and child. It seems obvious to us that some pesticide industry scientist somewhere is ultimately going to use the health standard in the law as justification for testing pesticides on children. This all too predictable outcome would be potentially tragic and outrageous.
Two previous expert panels concurred. The EPA's FIFRA Scientific Advisory Panel (SAP) and the EPA Science Advisory Board both explicitly concluded that pesticide tests on children are unethical and should never be accepted by the EPA. Your panel, perhaps by virtue of omission, has totally undermined the prior consensus on this issue, and unwittingly opened the door to what most scientists view as a highly unethical testing regime.
This oversight reflects a rudimentary lack of understanding of the policy context into which the report's recommendations will be injected. It concerns us deeply that the panel was apparently not aware that the EPA, as a matter of policy, and acting against the recommendations of its own SAP, generally has not implemented the additional FQPA 10-fold children's safety factor for organophosphate insecticides (OPs).
In the real world, extra protections for children from pesticides are a regulatory goal, not standard practice. The committee explicitly shielded the 10-fold safety factor in its report, but apparently was unaware that in doing so it had protected a safety margin that in practice at the EPA does not exist for most pesticides where human studies have been conducted.
With that oversight as a foundation, the committee then goes on to say that human data for cholinesterase-inhibiting pesticides can "eliminate the need for the uncertainty factor ordinarily used to extrapolate from animals to humans of average sensitivity." But what about the fact that millions of people are not of average sensitivity, but are perhaps orders of magnitude more sensitive to the adverse effects of OPs?
With the FQPA 10-fold safety margin for children not in place for OPs and human data considered sufficient to eliminate another 10-fold, the impact of the committee's report will be to reduce protections from cholinesterase-inhibiting pesticides to a 10-fold margin, a rollback of health protections to depths not seen since the 1950s when there were essentially no standards in place to protect the public from pesticides and pollutants.
We can only presume that this was not the committee's intent. It will, unfortunately, very likely be the effect.
With OP insecticides, this is particularly problematic because it is established beyond any reasonable doubt that there is more than a 10-fold variability in OP detoxification capacity and metabolism within the U.S. population of 280 million people, 30 million of whom are under age 5.
The committee must amend the report to make clear that under no circumstances should there ever be less than a 100-fold safety margin used in regulatory standard setting, even in situations where human data are used.
We look forward to your reply.
Senior Vice President
Cc: Committee Members
Senator Patrick Leahy
Senator Edward Kennedy
Congressman Henry Waxman
EPA Assistant Administrator Stephen Johnson
EPA Principle Deputy Assistant Administrator Susan Hazen