Washington, DC -- The U.S. Environmental Protection Agency is paying selected Florida families who "spray or have pesticides sprayed inside your home routinely" to study their infant children, according to agency documents released today by Public Employees for Environmental Responsibility (PEER). When agency scientists started questioning the ethics of the study, EPA removed the study protocol from its website and distributed a short "Desk Statement" that the scientists say is misleading.
Conducted with funding from the American Chemistry Council, which represents 135 companies including pesticide manufacturers, the Children's Environmental Exposure Research Study (CHEERS) will monitor developmental changes in babies, from birth to age 3, who are exposed to pesticides in their homes. Set in Jacksonville, Florida (Duval County), the study looks at 60 infants and toddlers. Agency scientists not connected with the study are expressing concerns about –
· Financial Incentives. The study makes payments to families totaling $970 for participating throughout the entire two-year period. Families who complete the study also get to keep the camcorder they are provided to record their babies' behavior. In addition, families are given bibs, t-shirts and other promotional items. Families are recruited from public clinics and hospitals;
· Lack of Treatment. The study makes no provision for intervening if infants or toddlers show signs of developmental problems or register alarmingly high exposure levels in their urine samples. Instead, families continue in the study so long as researchers are notified when each pesticide application occurs; and · Lack of Education. Unlike other EPA programs in this area, the study does not provide participants information about the safe or proper ways to apply or store pesticides around the home. Nor does the study furnish participating families with information about the risks of prolonged or excessive exposure to pesticides.
EPA scientists began raising these concerns and questioning the value of the study itself. Farm workers or others who have pesticide exposure outside the home are not excluded, nor are children with pre-existing health issues. In fact, the study protocol declares "It will not be possible to draw inferences to a larger population from the results of the study."
EPA reacted to these questions by removing the study protocol from its website. The agency then began distributing a two page Desk Statement that claims, "Participants are not required to use pesticides." While 10 percent of the participants are the control group with no or low pesticide exposure in their homes, the remaining 90 percent are eligible to enter and remain in the study only if they who spray routinely. Indeed, the infants are selected based upon pesticide residue levels detected in "a surface wipe sample in the primary room where the child spends time."
"If EPA is going to engage in experimentation on human subjects, especially infants, it should go the extra mile to be aboveboard and protective of the subjects' health," stated PEER executive Director Jeff Ruch, noting the Bush Administration has been pushing to liberalize rules on using human testing of pesticides and other chemicals. "Removing the study design from the EPA website and then issuing defensive, weasel-worded statements is hardly confidence inspiring."
In its Desk Statement, EPA claims that the "study protocols have been reviewed and approved by four Independent Institutional Review Boards for the protection of Human Subjects" but does not make copies of those reviews available.
The American Chemistry Council, which contributed $2 million to CHEERS, also successfully lobbied to include exposure to flame retardants and other household chemicals in the study. EPA defends the industry involvement, pointing to 80 similar research agreements it has with industry.
"The danger of these arrangements is that, in order to win industry support, EPA tailors its research to serve the objectives of corporate R & D first and public health second," Ruch added.
A complete copy of the protocol is available upon request