LIEBERMAN, MARKEY SEEK CHANGES IN CTIA-FDA RESEARCH AGREEMENT

Lieberman and Markey emphasized need for potential changes in cooperative R&D agreement (CRADA) between FDA and CTIA on cellphone health effects, expressing concerns that industry group had too much control over testing decisions. “This report finds real problems in the cooperative agreement between the FDA and the cellphone industry,” Markey said. Questions on research agreement include whether FDA can decide who researchers are, which research is pursued and whether results are published. “We cannot have a cooperative agreement where an industry which has a stake in the results can handcuff a federal agency in terms of the selection of who the researchers are … and whether or not results are published.” Markey stressed that FDA “must have more control” and that agreement as outlined in GAO report was “unacceptable.” Lieberman expressed optimism FDA would be able to respond to GAO evaluation in manner that would allow it to go forward. Markey suggested that if independent role of federal agencies couldn’t be established, option would be full federal funding of such research. Markey and Lieberman wrote letter to National Institutes of Health (NIH) Acting Dir. Ruth Kirschstein asking that NIH and FDA review whether govt. should support more research on potentially harmful health effects of RF emissions from mobile phones.

CTIA and FDA signed CRADA last June on potential health issues involved in wireless phone safety, with FDA providing research recommendations and oversight of studies and CTIA furnishing $1 million in funding over 3 years. This research represents narrower follow-up to Wireless Technology Research that CTIA had funded over 5-year period, which GAO report noted had “become caught up in public controversy” and raised some preliminary issues for further study. For latest joint effort with FDA, GAO report said CTIA “retains the final authority to decide which proposals are chosen and funded” and that association had outlined its intentions to follow FDA recommendations on research agenda. While public meetings have been held on developing research recommendations, “at the time we completed our audit work, FDA had not yet decided the extent to which it would make public its recommendations to CTIA on which proposals to fund,” report said. “If these recommendations are not publicly available in some form, it will not be possible to ensure that CTIA is following FDA’s recommendations.”

CTIA Vp-External and Industry Relations Jo-Anne Basile said Assn. took pains to structure research agreement to retain independence of FDA role. CRADA stipulates “the research must be made publicly available and published in peer reviewed scientific journals. The research is not owned by CTIA,” she told us. Basile said CTIA will receive no information that is not given concurrently to FDA. “FDA is responsible for really guiding the substance or the science of the studies,” she said. “We have followed FDA’s recommendations with respect to what should be studied.” Basile said FDA asked CTIA to administer contracts as part of original agreement, with FDA having control over content and direction of research. “It’s in CTIA’s interest to ensure the question of the independence of the research is made very clear,” she said. “We have been very attentive to putting in safeguards into the actual contracts to ensure that FDA controls the scope of the research, and not CTIA.” In statement, CTIA Pres. Thomas Wheeler said: “CTIA supports the recommendations for the FCC and the FDA to continue to provide full information to the public on wireless phones and health.” He called report “balanced and fair.”

FDA “welcomes” recommendation of GAO report that agency make clear degree to which research contracts finalized by CTIA were responsive to FDA research recommendations, said Russell Owen, chief of radiation biology branch at FDA’s Center for Devices & Radiological Health. That step can’t be taken until after those negotiations are completed and contract decisions have been made, Owen told us. FDA expects that to be done “soon,” he said. In request for proposals that CTIA had issued last fall, it “incorporated our recommendations verbatim,” he said. FDA has reviewed CTIA’s actions in view of those initial recommendations and has advised group as to what FDA thinks should be done in terms of funding proposals, Owen said. FDA officials declined to respond to concern raised by Markey that CTIA could exercise control over whether research results were published. “We wouldn’t be able to respond to that today,” FDA spokeswoman said. “We will have a response to the senator and Congressman directly.”

In other areas, GAO report cited lack of standardized procedures on how phones should be tested for compliance with FCC’s RF exposure limit, recommending agency revise guidance procedures on specific absorption rate (SAR) testing. GAO highlighted shortcomings in FCC staffing levels in that area, recommending agency develop plan to secure additional personnel. Agency has one RF exposure specialist to oversee reviews of equipment authorization applications that involve RF exposure evaluation and to run new testing facility. FCC also has been planning to run spot tests of SAR levels of some phones at new OET lab. Report said FCC had been awaiting finalization of uniform SAR testing standards from IEEE committee, which still must resolve some technical issues before reaching agreement. Even with testing standards, SAR tests still can provide “only a best estimate of a phone’s maximum SAR level,” according to FCC officials cited in report. Based on measurement uncertainty due to several different factors, “FCC officials said that a phone’s actual maximum SAR level could fall somewhere within a range of 30% above or below the phone’s test results,” report said. In letter to FCC Chmn. Powell describing results of GAO report, Lieberman and Markey pointed out suggestion that Commission consult with FDA on “FDA’s methods for incorporating measurement uncertainty in determining compliance with radiofrequency limits.” Report cited “shortcomings” in consumer information efforts of FCC and FDA, recommending that agencies provide clearer information on Internet on RF exposure issues and what SAR data means.