But in 1982, the FDA merged the radiological health bureau into its medical-device unit.
“I was concerned that if they were to combine the two centers into one, it would probably mean the ending of the radiation program because the demands for medical-device regulation were becoming increasingly great,” said Villforth, who was put in charge of the new Center for Devices and Radiological Health. “As I sort of guessed, the radiation program took a big hit.”
The new unit became stretched for scarce resources as it tried to deal with everything from tongue depressors to industrial lasers. The government used to have 500 people examining the safety of electronic products emitting radiation. It now has about 20 people. In fact, the FDA has not set a mandatory safety standard for an electronic product since 1985.
As a result, there is an FDA safety regulation for X-rays scanning baggage — but none for X-rays scanning people at airports.
Meanwhile, scientists began developing backscatter X-rays, in which the waves are reflected off an object to a detector, for the security industry.
The Secure 1000 people scanner was invented by Smith in 1991 and later sold to Rapiscan, then a small security firm based in southern California. The first major customer was the California prison system, which began scanning visitors to prevent drugs and weapons from getting in. But the state pulled the devices in 2001 after a group of inmates' wives filed a class-action lawsuit accusing the prisons of violating their civil liberties.
The US Customs Service deployed backscatter machines for several years but in limited fashion and with strict supervision. Travelers suspected of carrying contraband had to sign a consent form, and Customs policy prohibited the scanning of pregnant women. The agency abandoned them in 2006, not for safety reasons but because smugglers had learned where the machines were installed and adapted their methods to avoid them, said Rick Whitman, the radiation safety officer for Customs until 2008.
Yet, even this limited application of X-ray scanning for security dismayed radiation safety experts. In 1999, the Conference of Radiation Control Program Directors, a nongovernmental organization, passed a resolution recommending that such screening be stopped immediately.
The backscatter machines had also caught the attention of the 1998 FDA advisory panel, which recommended that the FDA establish government safety regulations for people scanners. Instead, the FDA decided to go with a voluntary standard set by a trade group largely comprising manufacturers and government agencies that wanted to use the machines.
“Establishing a mandatory standard takes an enormous amount of resources and could take a decade to publish,” said Dan Kassiday, a longtime radiation safety engineer at the FDA.
In addition, since the mid-1990s, Congress has directed federal safety agencies to use industry standards wherever possible instead of creating their own.
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.
Last year, in reaction to public anger from members of Congress, passengers and advocates, the TSA contracted with the Army Public Health Command to do independent radiation surveys. But email messages obtained in a lawsuit brought by the Electronic Privacy Information Center, a civil liberties group, raise questions about the independence of the Army surveys.
One email sent by TSA health and safety director Jill Segraves shows that local TSA officials were given advance notice and allowed to “pick and choose” which systems the Army could check.
That email also suggests that Segraves considered the Rapiscan inspectors a valuable public-relations asset: “They are our radiation myth busters,” she wrote to a local security director.
Some TSA screeners are concerned about their own radiation exposure from the backscatters, but the TSA has not allowed them to wear badges that could measure it, said Milly Rodriguez, health and safety specialist for the American Federation of Government Employees, which represents TSA officers.
“We have heard from members that sometimes the technicians tell them that the machines are emitting more radiation than is allowed,” she said.
McCarthy, the TSA spokesman, said the machines are physically incapable of producing radiation above the industry standard. In the email, he said, the inspections allow screeners to ask questions about radiation and address concerns about specific machines.
The company’s lobbying campaign
While the TSA maintains that the body scanners are essential to preventing attacks on airplanes, it only began rolling them out nine years after 9/11.
After the attempted shoe-bombing in December 2001, the federal government conducted a trial of a Rapiscan backscatter at the Orlando International Airport. But the revealing images drew protests that the machines amounted to a virtual strip search.
The TSA considered the scanners again after two Chechen women blew up Russian airliners in 2004. Facing a continued outcry over privacy, the TSA instead moved forward with a machine known as a “puffer” because it released several bursts of air on the passengers’ clothes and analyzed the dislodged particles for explosives. But after discovering the machines were ineffective in the field and difficult to maintain, the TSA canceled the program in 2006.
Around that time, Rapiscan began to beef up its lobbying on Capitol Hill. It opened a Washington, DC, office and, according to required disclosures, more than tripled its lobbying expenditures in two years, from less than $130,000 in 2006 to nearly $420,000 in 2008. It hired former legislative aides to Rep. David Price, D-NC, then chairman of the homeland security appropriations subcommittee, and to Sen. Trent Lott, R-Miss.
It started a political action committee and began contributing heavily to Price; Rep. Bennie Thompson, D-Miss., then head of the homeland security committee; Rep. Jane Harman, D-Calif., also on that committee; and Sen. Thad Cochran, R-Miss., the top Republican on the Senate appropriations committee.
In addition, it opened a new North Carolina plant in Price’s district and expanded its operations in Ocean Springs, Miss., and at its headquarters in Torrance, Calif., in Harman’s district.
“Less than a month after U.S. Senator Trent Lott and other local leaders helped officially open Rapiscan Systems’ new Ocean Springs factory,” Lott’s office announced in a news release in late 2006, “the company has won a $9.1 million Department of Defense contract.”
But Rapiscan still hadn’t landed a major contract to roll out its X-ray body scanners in commercial airports. Indeed, in 2007, with new privacy filters in place, the TSA began a trial of millimeter-wave and backscatter machines at several major airports, after which the agency opted to go with the millimeter-wave machines. The agency said health concerns weren’t a factor.
But with the 2009 federal stimulus package, which provided $300 million for checkpoint security machines, the TSA began deploying backscatters as well. Rapiscan won a $173 million, multiyear contract for the backscatters, with an initial $25 million order for 150 systems to be made in Mississippi.
Three other companies — American Science & Engineering, Tek84 Engineering Group and Valley Forge Composite Technologies — make X-ray scanners, but none are used by the TSA. Peter Kant, executive vice president for Rapiscan, said the company expanded its lobbying because its business was increasingly affected by the government.
“There’s a lot of misinformation about the technology; there’s a lot of questions about how various inspection technologies work,” he said. “And we needed a way to be able to provide that information and explain the technology and how it works, and that’s what lobbying is.”
The lawmakers either declined to comment or said the lobbying, campaign contributions and local connections had nothing to do with the TSA’s decision to purchase Rapiscan machines. The TSA said the contract was bid competitively and that the winning machines had to undergo comprehensive research and testing phases before being deployed.
While the scanners were appearing in more and more airports, few passengers went through them, because they were used mostly for random screening or to resolve alarms from the metal detector.
That changed on Christmas Day 2009, when a Nigerian man flying to Detroit tried to ignite a pouch of explosives hidden in his underwear.
Following the foiled “Great Balls of Fire” suicide bombing, as the New York Postdubbed it, Homeland Security Secretary Janet Napolitano ramped up plans to roll out body scanners nationwide. Members of Congress and aviation security experts also pushed heavily for the TSA to install more machines that could detect explosives on passengers.
Harman sent a letter to Napolitano, noting that Rapiscan was in her district.
“I urge you to expedite installation of scanning machines in key airports,” Harman wrote in the letter, which was first reported by the website CounterPunch. “If you need additional funds, I am ready to help.”
Michael Chertoff, who had supported body scanners while secretary of Homeland Security, appeared frequently on TV advocating their use. In one interview, he disclosed that his consulting firm, Chertoff Group, had done work for Rapiscan, sparking accusations that he was trying to profit from his time as a government servant.
Despite the criticism, little has been revealed about the relationship. Rapiscan dismissed it, asserting that the consulting work had to do with international cargo and port security issues — not aviation.
“There was nothing that was not above board,” Kant said. “His comments about passenger screening and these machines were simply his own and was nothing that we had engaged the Chertoff Group for.”
A public records request by ProPublica turned up empty: The Department of Homeland Security said it could not find any correspondence to or from Chertoff related to body scanners. DHS also said Chertoff did not use email.
The Chertoff Group did not respond to requests for comment.
The TSA plans to deploy 1,275 backscatter and millimeter-wave scanners covering more than half its security lanes by the end of 2012 and 1,800 covering nearly all the lanes by 2014.
According to annual reports filed with the Securities and Exchange Commission, OSI Systems, the parent company of Rapiscan, has seen revenue from its security division more than double since 2006 to nearly $300 million in fiscal year 2011.
Miles O’Brien and Kate Tobin of PBS NewsHour contributed to this report.
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