The FDA delegated the task of establishing the voluntary standards to the American National Standards Institute. A private nonprofit that sets standards for many industries, ANSI convened a committee of the Health Physics Society, a trade group of radiation safety specialists. It was made up of 15 people, including six representatives of manufacturers of X-ray body scanners and five from U.S. Customs and the California prison system. There were few government regulators and no independent scientists.
In contrast, the FDA advisory panel was also made up of 15 people — five representatives from government regulatory agencies, four outside medical experts, one labor representative and five experts from the electronic products industry, but none from the scanner manufacturers themselves.
“I am more comfortable with having a regulatory agency — either federal or the states — develop the standards and enforce them,” Kaufman said. Such regulators, she added, “have only one priority, and that’s public health.”
A representative of the Health Physics Society committee said that was its main priority as well. Most of the committee’s evaluation was completed before 9/11. The standard was published in 2002 and updated with minor changes in 2009.
Ed Bailey, chief of California’s radiological health branch at the time, said he was the lone voice opposing the use of the machines. But after 9/11, his views changed about what was acceptable in pursuit of security.
“The whole climate of their use has changed,” Bailey said. “The consequence of something being smuggled on an airplane is far more serious than somebody getting drugs into a prison.”
Are Inspections Independent?
While the TSA doesn’t regulate the machines, it must seek public input before making major changes to security procedures. In July, a federal appeals court ruled that the agency failed to follow rule-making procedures and solicit public comment before installing body scanners at airports across the country. TSA spokesman Michael McCarthy said the agency couldn’t comment on ongoing litigation.
The TSA asserts there is no need to take additional precautions for sensitive populations, even pregnant women, following the guidance of the congressionally chartered National Council on Radiation Protection & Measurements.
But other authorities have come to the opposite conclusion. A report by France’s radiation safety agency specifically warned against screening pregnant women with the X-ray devices. In addition, the Federal Aviation Administration’s medical institute has advised pregnant pilots and flight attendants that the machine, coupled with their time in the air, could put them over their occupational limit for radiation exposure and that they might want to adjust their work schedules accordingly.
No similar warning has been issued for pregnant frequent fliers.
Even as people scanners became more widespread, government oversight actually weakened in some cases.
Inspections of X-ray equipment in hospitals and industry are the responsibility of state regulators — and before 9/11, many states also had the authority to randomly inspect machines in airports. But that ended when the TSA took over security checkpoints from the airlines.
Instead, annual inspections are done by Rapiscan, the scanners’ manufacturer.
“As a regulator, I think there’s a conflict of interest in having the manufacturer and the facility inspect themselves,” Kaufman said.