On Sept. 23, 1998, a panel of radiation safety experts gathered at a Hilton hotel in Maryland to evaluate a new device that could detect hidden weapons and contraband. The machine, known as the Secure 1000, beamed X-rays at people to see underneath their clothing.
One after another, the experts convened by the Food and Drug Administration (FDA) raised questions about the machine because it violated a longstanding principle in radiation safety — that humans shouldn’t be X-rayed unless there is a medical benefit.
“I think this is really a slippery slope,” said Jill Lipoti, who was the director of New Jersey’s radiation protection program. The device was already deployed in prisons; what was next, she and others asked — courthouses, schools, airports? “I am concerned … with expanding this type of product for the traveling public,” said another panelist, Stanley Savic, the vice president for safety at a large electronics company. “I think that would take this thing to an entirely different level of public health risk.”
The machine’s inventor, Steven W. Smith, assured the panelists that it was highly unlikely that the device would see widespread use in the near future. At the time, only 20 machines were in operation in the entire country.
“The places I think you are not going to see these in the next five years is lower-security facilities, particularly power plants, embassies, courthouses, airports and governments,” Smith said. “I would be extremely surprised in the next five to 10 years if the Secure 1000 is sold to any of these.”
Today, the United States has begun marching millions of airline passengers through the X-ray body scanners, parting ways with countries in Europe and elsewhere that have concluded that such widespread use of even low-level radiation poses an unacceptable health risk. The government is rolling out the X-ray scanners despite having a safer alternative that the Transportation Security Administration (TSA) says is also highly effective.
A ProPublica/PBS NewsHour investigation of how this decision was made shows that in post-9/11 America, security issues can trump even long-established medical conventions. The final call to deploy the X-ray machines was made not by the FDA, which regulates drugs and medical devices, but by the TSA, an agency whose primary mission is to prevent terrorist attacks.
Research suggests that anywhere from six to 100 U.S. airline passengers each year could get cancer from the machines. Still, the TSA has repeatedly defined the scanners as “safe,” glossing over the accepted scientific view that even low doses of ionizing radiation — the kind beamed directly at the body by the X-ray scanners — increase the risk of cancer.
“Even though it’s a very small risk, when you expose that number of people, there’s a potential for some of them to get cancer,” said Kathleen Kaufman, the former radiation management director in Los Angeles County, who brought the prison X-rays to the FDA panel’s attention.
About 250 X-ray scanners are currently in U.S. airports, along with 264 body scanners that use a different technology, a form of low-energy radio waves known as millimeter waves.
Robin Kane, the TSA’s assistant administrator for security technology, said that no one would get cancer because the amount of radiation the X-ray scanners emit is minute. Having both technologies is important to create competition, he added.
“It’s a really, really small amount relative to the security benefit you’re going to get,” Kane said. “Keeping multiple technologies in play is very worthwhile for the U.S. in getting that cost-effective solution — and being able to increase the capabilities of technology because you keep everyone trying to get the better mousetrap.”
Determined to fill a critical hole in its ability to detect explosives, the TSA plans to have one or the other operating at nearly every security lane in America by 2014. The TSA has designated the scanners for “primary” screening: Officers will direct every passenger, including children, to go through either a metal detector or a body scanner, and the passenger’s only alternative will be to request a physical pat-down.
How did the United States swing from considering such X-rays taboo to deeming them safe enough to scan millions of people a year?
A new wave of terrorist attacks using explosives concealed on the body, coupled with the scanners’ low dose of radiation, certainly convinced many radiation experts that the risk was justified. But other factors helped the machines gain acceptance.
A regulatory Catch-22
Because of a regulatory Catch-22, the airport X-ray scanners have escaped the oversight required for X-ray machines used in doctors’ offices and hospitals. The reason is that the scanners do not have a medical purpose, so the FDA cannot subject them to the rigorous evaluation it applies to medical devices.
Still, the FDA has limited authority to oversee some non-medical products and can set mandatory safety regulations. But the agency let the scanners fall under voluntary standards set by a nonprofit group heavily influenced by industry.
As for the TSA, it skipped a public comment period required before deploying the scanners. Then, in defending them, it relied on a small body of unpublished research to insist the machines were safe, and ignored contrary opinions from U.S. and European authorities that recommended precautions, especially for pregnant women. Finally, the manufacturer, Rapiscan Systems, unleashed an intense and sophisticated lobbying campaign, ultimately winning large contracts.
Both the FDA and TSA say due diligence has been done to assure the scanners’ safety. Rapiscan says it won the contract because its technology is superior at detecting threats. While the TSA says X-ray and millimeter-wave scanners are both effective, Germany decided earlier this year not to roll out millimeter-wave machines after finding they produced too many false positives.
Most of the news coverage on body scanners has focused on privacy, because the machines can produce images showing breasts and buttocks. But the TSA has since installed software to make the images less graphic. While some accounts have raised the specter of radiation, this is the first report to trace the history of the scanners and document the gaps in regulation that allowed them to avoid rigorous safety evaluation.