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Research Cooperation with the Cellular Telecommunications and Internet Association (CTIA)

FDA and the Cellular Telecommunications and Internet Association (CTIA) have a formal Cooperative Research and Development Agreement (CRADA) to do research on wireless phone safety. FDA provides the scientific oversight, obtaining input from experts in government, industry, and academic organizations. CTIA-funded research is conducted through contracts to independent investigators. The initial research will include both laboratory studies and studies of wireless phone users. The CRADA will also include a broad assessment of additional research needs in the context of the latest research developments around the world.

General Information About the CRADA

• FDA Talk Paper on the signing of the CRADA (Cooperative Research and Development Agreement) Text
• Cooperative Research and Development Agreement (CRADA) - Health Effects of RF Emissions from Wireless Phones (Mobile Units for Commercial Mobile Radio Services)
• CTIA CRADA Text
• Research Plan, CTIA CRADA Text

FDA Recommendations Concerning Research to be Conducted Under the CRADA

FDA has recommended CTIA fund research to address questions raised by previous studies on the effect of radio frequency exposure on micronucleus formation. The specific questions of interest to FDA are:

• Is the reported effect of RF exposure on lymphocytes accurate and reproducible?
• What is the role of temperature change in the observed results with RF exposure?
• Do In Vivo RF exposures increase micronucleous formation?

CTIA followed FDA’s recommendation and funded two In Vitro studies and one In Vivo study:

• Integrated Laboratory Systems, Research Triangle Park, NC. (In Vitro).
• Interuniversity Center on Interaction Between Electromagnetic Fields and Biosystems, Naples and Rome, Italy. (In Vitro).
• The Fraunhofer Institute of Toxicology and Aerosol Research, Hannover, Germany. (In Vivo).

The studies funded by CTIA satisfactorily address the research needs identified by FDA. FDA continues to monitor the progress of these studies through a regular series of progress reports and site visits.

Micronucleus Formation

• Federal Register Notice for a Meeting (August, 2000) Text
• Meeting Transcript, Day One WORD or PDF (note: file is 229 pages/339KB)
• Meeting Transcript, Day Two WORD or PDF (note: file is 99 pages/148KB)
• FDA Research Recommendations Text

Epidemiology (Studies of Human Populations)

• Federal Register Notice for a Meeting (April, 2001) Text
• Meeting Transcript, Day One WORD or PDF (note: file is 297 pages/357KB)
• Meeting Transcript, Day Two WORD or PDF (note: file is 87 pages/131KB)
• Federal Register Notice for a Meeting (May, 2001) Text
• Meeting Transcript, Day One WORD or PDF (note: file is 599 pages/577KB)
• Meeting Transcript, Day Two WORD or PDF (note: file is 281 pages/285KB)
• FDA Research Recommendations WORD, PDF or Text

Updated 3/24/03