ROCKVILLE, Md.-The inaugural meeting of a government-industry task force formed to examine the health effects of radio-frequency exposure listed a variety of studies to be conducted that could cost as much as $10 million.
“All of the studies we have been talking about here have been exotic, and if we were to do all of the in vitro and animal studies, not to mention the human experiments, we are talking about $10 million,” said Joseph Elder.
The Cellular Telecommunications Industry Association has agreed to fund follow-up studies to the $27 million research conducted by Wireless Technology Research L.L.C., which was paid for by CTIA members.
The follow-up studies are meant to provide definitive evidence of RF effects since two of the WTR studies were inconclusive.
The panel-formally the Effects of Radio-Frequency Energy Exposure on Micronucleus Formation convened by the Center for Devices and Radiological Health of the Food and Drug Administration-was formed because of a cooperative research and development agreement signed in June with CTIA.
“CTIA has committed to contract to do the research as directed by the CRADA,” said Russell D. Owen, chief of the radiology branch at the FDA’s Center for Devices and Radiological Health.
The CRADA came under scrutiny when it was signed because CTIA will have the final say in which studies will be conducted and which scientists will perform the studies.
The meeting was an information-gathering session only. The FDA group will collect data from the meeting and turn it over to CTIA in the next two to four weeks to develop an official request for proposals, said Owen.
This meeting focused on animal studies. A similar meeting will be held to discuss epidemiology, studies on people.
Luc Verschaeve of the genetic lab of the toxicology division of the environmental department of the Flemish Institute of Technological Research, said a review of the 100 to 150 studies of the health impacts of RF exposure shows that most have a negative rating. Some studies have positive readings, but most of the positive results are due to heating, not RF exposure, Verschaeve said.
These positive results have caused some to believe that RF exposure can cause cancer.
Determining whether it is indeed heat and not radiation and whether that heat was caused by RF exposure is a priority for the panel.
“The first priority is a real effect. They have repeated data, but the number of repetitions is not [conclusive] … Is it heat? Or is it radiation? Or is it a combination? If it is heat, then there are a whole series of studies that you can perform that study heat, at the same [time] studying the ability of the different technologies. If there is a radiation effect, it requires stepping back and making a hypothesis as to what the interaction would be … and that is more a complex and varied approach,” said Jerry R. Williams of Johns Hopkins University in Baltimore.
The group debated how much specific absorption rates should be tested and generally agreed an SAR of 10 was too high, even for whole animal studies, said W. Gregory Lotz of the National Institute for Occupational Safety and Health.
The discussion of whole animal studies-called in vivo in scientific circles-examined everything from whether mice or rats should be used and whether the animals can be restrained without causing too much difference in the results.
Dr. Joseph Roti Roti of Washington University, St. Louis, said in his studies, the rats got used to the restraints and went into the holders and went to sleep. Roti Roti conducted tests at the request and sponsorship of Motorola Inc.
It was also considered a priority to gather data and cells from mice subjects in an ongoing study in Australia.
The only CTIA official at the meeting was Jo-Anne R. Basile, CTIA vice president for external and industry relations. “It is not our meeting. It is FDA’s meeting. I am the principal investigator on the CRADA,” said Basile.
