Update (11/11): The FDA has responded to this story.
Update (11/01): This story has been updated with a comment from The Chertoff Group, from which ProPublica had sought comment before publication.
A PBS NewsHour story on X-ray body scanners, reported in conjunction with ProPublica, aired on Dec. 1.
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 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 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.
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.
Little research on
cancer risk of body scanners
Humans
are constantly exposed to ionizing radiation, a form of energy that has been
shown to strip electrons from atoms, damage DNA and mutate genes, potentially
leading to cancer. Most radiation comes from radon, a gas produced from
naturally decaying elements in the ground. Another major source is cosmic
radiation from outer space. Many common items, such as smoke detectors, contain
tiny amounts of radioactive material, as do exit signs in schools and office
buildings.
As a result, the cancer risk from
any one source of radiation is often small. Outside of nuclear accidents, such
as that at Japan’s Fukushima plant, and medical errors, the health risk comes
from cumulative exposure.
In Rapiscan’s
Secure 1000 scanner, which uses ionizing radiation, a passenger stands between
two large blue boxes and is scanned with a pencil X-ray beam that rapidly moves
left to right and up and down the body. In the other machine, ProVision, made by defense contractor L-3 Communications, a
passenger enters a chamber that looks like a round phone booth and is scanned
with millimeter waves, a form of low-energy radio waves, which have not been
shown to strip electrons from atoms or cause cancer.
Only a decade ago, many states
prohibited X-raying a person for anything other than a medical exam. Even after
9/11, such non-medical X-raying remains taboo in most of the industrialized
world. In July, the European Parliament passed a resolution that security
“scanners using ionizing radiation should be prohibited” because of health
risks. Although the United Kingdom uses the X-ray machine for limited purposes,
such as when passengers trigger the metal detector, most developed countries
have decided to forgo body scanners altogether or use only the millimeter-wave
machines.
While the research on medical
X-rays could fill many bookcases, the studies that have been done on the
airport X-ray scanners, known as backscatters, fill a file no more than a few
inches thick. None of the main studies cited by the TSA has been published in a
peer-reviewed journal, the gold standard for scientific research.
Those tests show that the Secure
1000 delivers an extremely low dose of radiation, less than 10 microrems. The dose is roughly one-thousandth of a chest
X-ray and equivalent to the cosmic radiation received in a few minutes of
flying at typical cruising altitude. The TSA has used those measurements to say
the machines are “safe.”
Most of what researchers know about
the long-term health effects of low levels of radiation comes from studies of
atomic bomb survivors in Hiroshima and Nagasaki. By charting exposure levels
and cancer cases, researchers established a linear link that shows the higher
the exposure, the greater risk of cancer.
Some scientists argue the danger is
exaggerated. They claim low levels stimulate the repair mechanism in cells,
meaning that a little radiation might actually be good for the body.
But in the authoritative report on
low doses of ionizing radiation, published in 2006, the National Academy of
Sciences reviewed the research and concluded that the preponderance of research
supported the linear link. It found “no compelling evidence” that there is any
level of radiation at which the risk of cancer is zero.
Radiation
experts say the dose from the backscatter is negligible when compared to
naturally occurring background radiation. Speaking to the 1998 FDA panel,
Smith, the inventor, compared the increased risk to choosing to visit Denver
instead of San Diego or the decision to wear a sweater versus a sport coat.
Using
the linear model, even such trivial amounts increase the number of cancer
cases. Rebecca Smith-Bindman, a radiologist at the
University of California, San Francisco, estimated that the backscatters would
lead to only six cancers over the course of a lifetime among the approximately
100 million people who fly every year. David Brenner, director of Columbia
University’s Center for Radiological Research, reached a higher number —
potentially 100 additional cancers every year.
“Why
would we want to put ourselves in this uncertain situation where potentially
we’re going to have some cancer cases?” Brenner asked. “It makes me think,
really, why don’t we use millimeter waves when we don’t have so much
uncertainty?”
But even without the machines, Smith-Bindman said, the same 100 million people would develop 40
million cancers over the course of their lifetimes. In this sea of cancer
cases, it would be impossible to identify the patients whose cancer is linked
to the backscatter machines.
How the scanners
avoided strict oversight
Although
they deliberately expose humans to radiation, the airport X-ray scanners are
not medical devices, so they are not subject to the stringent regulations
required for diagnostic X-ray machines.
If they were, the manufacturer
would have to submit clinical data showing safety and effectiveness and be
approved through a rigorous process by the FDA. If the machines contained
radioactive material, they would have to report to the Nuclear Regulatory
Commission.
But because it didn’t fit into
either category, the Secure 1000 was classified as an electronic product. The
FDA does not review or approve the safety of such products. However,
manufacturers must provide a brief radiation safety report explaining the dose
and notify the agency if any overexposure is discovered. According to the FDA,
no such incidents have been reported.
Under its limited oversight of
electronic products, the FDA could issue mandatory safety regulations. But it
didn’t do so, a decision that flows from its history of supervising
electronics.
Regulation of electronic products
in the United States began after a series of scandals. From the 1930s to the
1950s, it was common for a child to go to a shoe store and stand underneath an
X-ray machine known as a fluoroscope to check whether a shoe was the right fit.
But after cases arose of a shoe model’s leg being amputated and store clerks
developing dermatitis from putting their hands in the beam to adjust the shoe,
the practice ended.
In
1967, General Electric recalled 90,000 color televisions that had been sold
without the proper shielding, potentially exposing viewers to dangerous levels
of radiation. The scandal prompted the creation of the federal Bureau of
Radiological Health.
“That
ultimately led to a lot more aggressive program,” said John Villforth,
who was the director of the bureau. Over the next decade, the bureau created
federal safety standards for televisions, medical X-rays, microwaves, tanning
beds, even laser light shows.
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
U.S. 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 Army 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. On 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, D.C., 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-N.C., 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.”
In a statement, the Chertoff Group said it “played no role in the sale of whole body imaging technology to TSA” and that Chertoff “was in no way compensated for his public statements.”
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
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.
