Cell phone radiation
FDA/CDRH regulates cell phone radiation (post-market, i.e. no regulatory
action unless there are strong epidemiological signs of adverse events).
Pre-market clearance is entirely different, where safety and efficacy
must be demonstrated. When the Federal Communications Commission (FCC)
requested a review of the genotoxicity data on cell phone radiation, I
was the only person remotely qualified. Actually, CDRH had a long
history of radiological assessments, including Extra Low Frequency
radiation (ELF), but the difficulties involved in assessing and
understanding it led the Center to give up on this area. I should have
realized that no one else would agree to touch it. I reviewed some 900
papers on the genotoxicity assessment of cell phone radiation assembled
by the FDA library. The review showed a combination of mostly inadequate
or unremarkable studies, including a few that were fraudulent (as outed
in other papers), along with several concerning epidemiological studies.
Meanwhile the NIEHS had spent 10 years creating an experimental design
that provided adequate exposure of mice without immobilizing them, to
allow irradiation of their heads. This project was kept secret even from
my supervisor. Kristine Witt and I communicated in code and secretly at
EMGS meetings. Finally, the results became available. NIEHS found some
comet assay positives. Kristine and I independently assessed the results
as “not nothing”. However, the Center reverted to the post-market lack
of evidence of harm as the regulatory standard. After some difficulty,
NIEHS published the results, but no one seemed to care.