Report: Increased Mishaps in U.S. Testing Labs
Tuesday, October 02, 2007
WASHINGTON — American laboratories handling the world's deadliest germs and toxins have experienced more than 100 accidents and missing shipments since 2003, and the number is increasing steadily as more labs across the country are approved to do the work.
No one died, and regulators said the public was never at risk during these incidents. But the documented cases reflect poorly on procedures and oversight at high-security labs, some of which work with organisms and poisons so dangerous that illnesses they cause have no cure. In some cases, labs have failed to report accidents as required by law.
The mishaps include workers bitten or scratched by infected animals, skin cuts, needle sticks and more, according to a review by The Associated Press of confidential reports submitted to federal regulators. They describe accidents involving anthrax, bird flu virus, monkeypox and plague-causing bacteria at 44 labs in 24 states. More than two-dozen incidents were still under investigation.
The number of accidents has risen steadily. Through August, the most recent period covered in the reports obtained by the AP, labs reported 36 accidents and lost shipments during 2007 - nearly double the number reported during all of 2004.
Research labs have worked for years to find cures and treatments for diseases. However, the expansion of the lab network has been dramatic since President Bush announced an upgrade of the nation's bio-warfare defense program five years ago. The National Institute of Allergy and Infectious Diseases, which funds much of the lab research and construction, was spending spent about $41 million on bio-defense labs in 2001. By last year, the spending had risen to $1.6 billion.
The number of labs approved by the government to handle the deadliest substances has nearly doubled to 409 since 2004. Labs are routinely inspected by federal regulators just once every three years, but accidents trigger interim inspections.
"It may be only a matter of time before our nation has a public health incident with potentially catastrophic results," said Rep. Bart Stupak, D-Mich., chairman of the House Energy and Commerce investigations subcommittee. Stupak's panel has been investigating the lab incidents and will conduct a hearing Thursday.
Lab accidents have affected the outside world: Britain's health and safety agency concluded there was a "strong probability" a leaking pipe at a British lab manufacturing vaccines for foot-and-mouth disease was the source of an outbreak of the illness in livestock earlier this year. Britain was forced to suspend exports of livestock, meat and milk products and destroy livestock. The disease does not infect humans.
Accidents aren't the only concern. While medical experts consider it unlikely that a lab employee will become sick and infect others, these labs have strict rules to prevent anyone from stealing organisms or toxins and using them for bioterrorism.
The reports were so sensitive the Bush administration refused to release them under the Freedom of Information Act, citing an anti-bioterrorism law aimed at preventing terrorists from locating stockpiles of poisons and learning who handles them.
Among the previously undisclosed accidents:
-In Rockville, Md., ferret No. 992, inoculated with bird flu virus, bit a technician at Bioqual Inc. on the right thumb in July. The worker was placed on home quarantine for five days and directed to wear a mask to protect others.
-An Oklahoma State University lab in Stillwater in December could not account for a dead mouse inoculated with bacteria that causes joint pain, weakness, lymph node swelling and pneumonia. The rodent - one of 30 to be incinerated - was never found, but the lab said an employee "must have forgotten to remove the dead mouse from the cage" before the cage was sterilized.
-In Albuquerque, N.M., an employee at the Lovelace Respiratory Research Institute was bitten on the left hand by an infected monkey in September 2006. The animal was ill from an infection of bacteria that causes plague. "When the gloves were removed, the skin appeared to be broken in 2 or 3 places," the report said. The worker was referred to a doctor, but nothing more was disclosed.
-In Fort Collins, Colo., a worker at a federal Center for Disease Control and Prevention facility found, in January 2004, three broken vials of Russian spring-summer encephalitis virus. Wearing only a laboratory coat and gloves, he used tweezers to remove broken glass and moved the materials to a special container. The virus, a potential bio-warfare agent, could cause brain inflammation and is supposed to be handled in a lab requiring pressure suits that resemble space suits. The report did not say whether the worker became ill.
Other reports describe leaks of contaminated waste, dropped containers with cultures of bacteria and viruses, and defective seals on airtight containers. Some recount missing or lost shipments, including plague bacteria that was supposed to be delivered to the Armed Forces Institute of Pathology in 2003. The wayward shipment was discovered eventually in Belgium and incinerated safely.
The reports must be submitted to regulators whenever a lab suffers a theft, loss or release of any of 72 substances known as "select agents" - a government list of germs and toxins that represent the horror stories of the world's worst medical tragedies for humans and animals.
A senior CDC official, Dr. Richard Besser, said his agency is committed to ensuring that U.S. labs are safe and that all such incidents are disclosed to the government. He said he was unaware of any risk to the public resulting from infections among workers at the high-security labs, but he acknowledged that regulators are worried about accidents that could go unreported.
"If you're asking if it's possible for someone to not report an infection, and have it missed, that clearly is a concern that we have," Besser said.
Texas A&M's laboratory failed to report, until this year, one case of a lab worker's infection from Brucella bacteria last year and three others' previous infection with Q fever - missteps documented in news reports earlier this year. The illnesses are characterized by high fevers and flu-like symptoms that sometimes cause more serious complications.
"The major problems at Texas A&M went undetected and unreported, and we don't think that it was an isolated event," critic Edward Hammond said. He runs the Sunshine Project, which has tracked incidents at other labs for years and first revealed the Texas A&M illnesses that the school failed to report.
Rules for working in the labs are tough and are getting more restrictive as the bio-safety levels rise. The highest is Level 4, where labs study substances that pose a "high risk of life-threatening disease for which no vaccine or therapy is available." Besides wearing wear full-body, air-supplied suits, workers undergo extensive background checks and carry special identification cards.
"The risk that a killer agent could be set loose in the general population is real," Hammond said.
In other lab accidents recounted in the reports, the Public Health Research Institute in Newark, N.J., was investigated by the FBI in 2005 when it couldn't account for three of 24 mice infected with plague bacteria. The lab and the CDC concluded the mice were cannibalized by other plague-infested mice or buried under bedding when the cage was sterilized with high temperatures.
The lab's director, Dr. David Perlin, told the AP it would be impossible for mice to escape from the building and said a worker failed to record their deaths.
"I feel 99 percent comfortable that was the case," Perlin said. "The animals become badly cannibalized. You only see bits and pieces. They're in cages with shredded newspaper. You really have to search hard with gloves and masks."
A worker at the Army's biological facility in Fort Detrick, Md., was grazed by a needle in February 2004 and exposed to the deadly Ebola virus after a mouse kicked a syringe. She was placed in an isolation ward called "The Slammer," but the Army said she did not become ill.
In other previously undisclosed accidents:
In Decatur, Ga., a worker at the Georgia Public Health Laboratory handled a Brucella culture in April 2004 without high-level precautions. She became feverish months later and tested positive for exposure at a hospital emergency room in July. She eventually returned to work. The lab's confidential report defended her: "The technologist is a good laboratorian and has good technique."
In April this year at the Loveless facility in Albuquerque, an African green monkey infected intentionally with plague-causing bacteria reached with its free hand and scratched at a Velcro restraining strap, cutting into the gloved hand of a lab worker. The injured worker at the Lovelace Respiratory Research Institute received medical treatment, including an antibiotic.
The National Animal Disease Center in Ames, Iowa, reported leaks of contaminated waste three times in November and December 2006. While one worker was preparing a pipe for repairs, he cut his middle finger, possibly exposing him to Brucella, according to the confidential reports.
A researcher at the CDC's lab in Fort Collins, Colo., dropped two containers on the floor last November, including one with plague bacteria.
A worker at Walter Reed Army Institute of Research-Naval Medical Research Center in Silver Spring, Md., sliced through two pair of gloves while handling a rat carcass infected with plague bacteria. The May 2005 report said she was sent to an emergency room, which released her and asked her to return for a follow-up visit.