Biotech or biohazard? (5/8/2007)

EXTRACTS: Viruses or bacteria escaped. Employees got sick. Others were infected. Those are the accidents we know about.

...even a minor outbreak - of foot-and-mouth disease, Nipah virus or Japanese encephalitis, three diseases Homeland Security says will be studied there - could devastate North Carolina's cattle and swine industry and imperil human health.

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Biotech or biohazard?
A proposed federal lab in Butner would study the world's deadliest diseases
BY LISA SORG The Indepenent Weekly, JULY 25 2007
http://www.indyweek.com/gyrobase/Content?oid=oid%3A157592

Smallpox could be coming to Butner. Or anthrax. Or Rift Valley fever, which is passed from infected animals and biting insects to humans. It can cause its victims' brains to swell and their organs to hemorrhage. Then they die.

These are among the diseases that could be studied at the National Bio and Agro-Defense Facility, a new 520,000-square-foot federal laboratory designed to research and combat the world's deadliest germs and potential biological weapons. Umstead Research Farm near Butner, less than a half-hour from Durham and Raleigh, is among five finalist locations for the lab.

The Department of Homeland Security, which is in charge of the project, announced July 11 that the farm had made the short list, and the N.C. Consortium - Triangle business, government and university leaders who had submitted a site proposal to DHS - was atwitter. Granville County Economic Development Commission Director Leon Turner extolled the economic impacts, estimated at $1.7 billion over 20 years - although many of the estimated 300 new jobs will go to specialized researchers. Associate Professor Barrett Slenning, who leads N.C. State University's Animal Biosecurity Risk Management Group, touted the advanced research and scholarship possibilities. Ken Tindall, vice president of N.C. Biotechnology Center, lauded the near-certain expansion of the Triangle's flourishing biotech industry.

However, before the champagne corks are popped, there is reason for caution, even skepticism. For decades, the new lab's predecessor, Plum Island Animal Disease Research Center, a 50-year-old, lab located off the tip of Long Island, N.Y., has been chronically plagued by grave security breaches and safety violations that point to managerial incompetence by Homeland Security and the U.S. Department of Agriculture.

And at dozens of private and government labs operating at lower bio-security levels, such as at Texas A&M and Fort Detrick, Md., human error or negligence compromised the facilities' safety and security. Viruses or bacteria escaped. Employees got sick. Others were infected. Those are the accidents we know about. No statistics have been compiled on these breaches, and as reported in an April edition of the journal Nature, biosafety experts say mishaps and near misses frequently occur, but aren't reported.

Proponents of the proposed lab have assured the public that the $450 million, state-of-the-art laboratory will be safe and secure, emphasizing that at no U.S. lab of its kind, a Biosafety Level-4, have there been significant releases or worker exposures; nor have any of the dozens of BSL-3 facilities in the Triangle reported such incidents.

BSL-4 labs require the highest security and safety levels because of the life-threatening diseases studied in them. Lower-level facilities, BSL-1 through BSL-3, research comparatively less risky pathogens.

"We would not be supporting it if we thought the risk would be great to our citizens," says Steve Cline, deputy state public health director of the N.C. Department of Health and Human Services.

The new facility might be safe. But if it's not, even a minor outbreak - of foot-and-mouth disease, Nipah virus or Japanese encephalitis, three diseases Homeland Security says will be studied there - could devastate North Carolina's cattle and swine industry and imperil human health.

No wider than a pickup truck, the rutted red clay path cuts through pastures where cattle are clumped beneath shade trees. It delves into the forest and passes a small clearing where a cemetery rests among the pines. One of this site's selling points is its remoteness. On the 4,000-acre Umstead Research Farm, operated by the state agriculture department, two parcels are being considered: 104 acres of dense forest near the state National Guard camp, and 178 acres of scrub teeming with ticks and fire ants more than a mile off Range Road.

"This is in an area where we have very good control of the lands around them," says N.C. State's Slenning, the lead writer of the consortium's proposal. "There are no private landowners nearby."

But that is not to say there aren't people around. In addition to its own residents, Butner has at least 6,000 "contained populations," people who, coincidentally, cannot object to the siting of a high-security lab in their neighborhood. More than 1,000 men live at the state's Polk Correctional Institution. Another 114 are housed at the Umstead Correctional Center, a former prisoner-of-war camp. There are roughly 4,400 inmates at Butner's federal prisons, and another 125 juvenile offenders, ages 10 to 18, at the C.A. Dillon Youth Development Center.

The Umstead State Hospital and Whitaker School, both psychiatric facilities, hold about 400 patients, while the Murdoch School is home to 550 people with developmental disabilities.

Site proponents see little risk in escaped prisoners or psychiatric patients wandering onsite. In fact, the presence of prisons and hospitals "could be viewed as a benefit," Deputy State Public Health Director Cline says. "Those facilities are already secure."

Nor do they seem concerned that the inmates, patients and residents of these institutions could be exposed to biological agents. After Hurricanes Fran and Floyd, those facilities designed emergency management plans, which could be used in case of a biological accident, Cline says. "They have plans to either hold those populations in place and protect them, or evacuate them."

Security, consortium members say, is among the site's pluses. Butner, a state government-owned town, uses a state police force, the N.C. Department of Crime Control and Public Safety, whose officers are also trained as firefighters. (Within a week, the state plans to cede control of Butner, which would become an incorporated town. It remains unclear how this will affect the police force.)

However, the department wouldn't be in charge of internal security at the lab. Nor would they extinguish a major fire there. In case of an accident, area hazardous materials teams would respond, escorted by Butner's police force once they reached the town limits. The closest hazmat teams are in Raleigh and Durham, according to the consortium's proposal, and couldn't reach the site until 35 to 50 minutes after it received the emergency calladequate time, Slenning says.

Asked if that was an acceptable response time, William Dudley, chief deputy secretary of the Department of Crime Control and Public Safety, replied, "Apparently, they think it's sufficient to meet the challenge."

Safety and security have been consistent challenges at the proposed lab's predecessor, Plum Island, which was operated by the USDA from 1954 until it transferred power to Homeland Security in 2002. Plum Island, and by extension the proposed facility, is charged with protecting agriculture and food supply from foreign diseases and terrorist attacks.

Yet, a series of major blunders, many documented in Michael Carroll's investigative book about Plum Island, Lab 257, and others detailed in damning government reports, raised critics' concerns that neither the Agriculture Department nor Homeland Security can adequately manage such a high-risk lab, and fueled speculation that similar violations could occur at the proposed facility.

DHS didn't return repeated phone calls and messages seeking comment.

The Government Accountability Office, the investigational arm of Congress, reported that in July 2003, a year after Homeland Security had assumed control of Plum Island, eight foreign scientists were working in its biocontainment area without completed background investigations. The scientists were neither escorted nor monitored while in that sensitive area. Homeland Security officials told government investigators they "are developing a more restrictive policy for allowing scientists from other countries to have access to pathogens."

The report points out that a scientist could steal a pathogen from the lab "and potentially develop it into a weapon for spreading disease." Smallpox and Venezuelan equine encephalitis, studied at Plum Island and likely to be at the proposed facility, can be developed into human biowarfare agents.

Although the USDA told investigators that employees' background checks were updated every five years, according to personnel records, 12 workers, including some who have access to pathogens, haven't had theirs updated in more than a decade.

These are the very agencies that would oversee the proposed facility. (The U.S. Department of Health and Human Services would also be involved.) Carroll, whose book exhaustively details the USDA's incompetence at Plum Island, calls Homeland Security's oversight "horrendous." In an interview with the Independent, he added, "People need to be aware and recognize the mistakes at Plum Island can be replicated to some other place. The community needs to get assurances and oversight."

U.S. Rep. Brad Miller, whose district includes Granville County, agrees. A member of the Science and Technology Subcommittee for Investigations and Oversight, Miller says he was initially concerned about the diseases that would be studied at the proposed lab.

"Smallpox will be in Butner. Ebola will be in Butner," says Miller, who nonetheless supports the siting the facility there. "We need absolute assurance that there are no external threats."

The threats have also been internal. The 2003 GAO report further concluded that "access to pathogens is not adequately controlled" inside Plum Island. The foot-and-mouth disease vaccine bank, the only one in North America, represents years of cooperative research among the United States, Mexico and Canada. Yet, the room containing the bank has a window opening covered only with plywood. "USDA officials said they intend to improve the physical security of the vaccine bank," the report reads, "but have not yet decided on the approach to take."

Although not usually fatal, foot-and-mouth disease is highly contagious and quite painful for the animals. Economically, it can wipe out farmers, who can't export meat, leather and other related products for one year, and must quarantine their herds.

(For the proposed lab to handle the virus, Congress would have to rewrite the law to allow it on the mainland United States. A law passed in the 1950s prohibited the pathogen from leaving Plum Island, where it has remained for 50 years.)

There hasn't been a U.S. outbreak of the disease since 1929, but the virus did escape from a Plum Island laboratory in 1978, possibly through leaky air gaskets in the roof. Two hundred animals corralled outside became infected and had to be destroyed. A second, smaller breach occurred in 2004, although Homeland Security contended it remained inside the lab's biocontainment area and didn't infect any animals.

Sandy Hays Miller, spokeswoman for the Agricultural Research Service, a division of the USDA, says the agency changed its policies and animals are no longer held outdoors on the island.

Given the 10 million hogs in North Carolina—the state ranks second in the nation in annual swine production—an outbreak of Nipah virus, which will be studied at the proposed lab, could destroy hog herds and paralyze the industry.

"I can't think of a worse place NBAF could be than in the middle of the hog industry," Carroll says.

However, hog producers' fears have been allayed, says Deborah Johnson, CEO of the N.C. Pork Council. "Naturally, you do have concerns about the diseases being researched, but we had Barrett Slenning come and talk to the board of directors before we supported it. I feel good about the federal and state protection."

The hog industry is concentrated in the eastern part of the state, Slenning explains, adding that labs will be designed with redundant safety controls to keep pathogens "in a box within a box within a box. The chance of an agent getting out is small."

Bundy Plyler, executive director of the N.C. Cattlemen's Association, reinforces the importance of continued research on foreign animal diseases. A decade ago, the cattle lobby fought to keep Plum Island funded and open.

"I'm not afraid of some type of leak. I trust in the process," Plyler says. "I'm just glad we aren't arguing about the necessity of a facility. You can quibble about where to put it."

Plum Island was purposely located more than two miles offshore of Long Island to keep pathogens off the mainland. "Deer swim and birds fly," Slenning says of Plum Island, which was in a migratory bird pathway and wildlife often swam across Long Island Sound to the mainland. "It gave people a false sense of comfort."

Level 4 labs have since been sited in major cities, such as Frederick, Md., and Atlantawhere, at the Centers for Disease Control last month, lightning blew out the power in a soon-to-be-unveiled Level 4 lab. The backup generators didn't come on, but federal officials maintained that even if the lab had been operating, there were enough safety controls to prevent pathogens from escaping.

The power failure at the CDC is one of dozens of reported foul-ups—and many breaches are not—in the past decade, including several anthrax releases at western Maryland's Fort Detrick, home to a Level 4 lab and other lower-level facilities. Three researchers at a Level 3 lab at the Infectious Disease Research Institute in Seattle were infected with tuberculosis after a seal leak. According to ScienceNow, federal officials earlier this month suspended all research on dangerous pathogens at Texas A&M (foiling its proposal to Homeland Security for the site—it was an early contender) after the school last year didn't report cases of worker exposure to brucellosis and Q Fever—both potential bioweapons. One person became ill with brucellosis but recovered.

"Those sorts of things are intolerable," says U.S. Rep. David Price of the lapses at Plum Island and other labs. Yet, he also supports siting the proposed lab in Butner. "With the assurance—and we've had it thus far—that security and environmental issues are given very, very careful attention, this would be good for the Triangle."

With that level of attention, N.C. Consortium members say, the economic and research benefits outweigh the very small risks.

"From my perspective, there is no downside," says Ken Tindall, vice president of the N.C. Biotechnology Center. "All of the safety issues and management will be in place."

Now that Homeland Security has winnowed the list of potential sites from 29 to five, the federal government is scheduled to spend 2008 conducting an environmental assessment at each site: San Antonio, Texas; Manhattan, Kan.; Madison County, Miss.; and Athens, Ga.

Homeland Security is legally required to hold public hearings on the environmental impact study.

At the unwooded site, wetlands lie nearby. In the middle of a field, cattails are growing. Gaming lands have been established near the farm and at the National Guard Camp, both near the proposed site parcels, although they would likely close if the proposed facility were built. The consortium's proposal says the 30-acre facility will be built away from watershed creeks, wetlands and sensitive areas. Nearby, Falls Lake, a recreational lake and water supply for 350,000 Wake County residents, is buffered by the town of Butner, woods and grasslands.

With its veterinary, agricultural and biotech resources, consortium members say the Triangle is tailor-made for the proposed lab. Yet, politics are expected to loom large in Homeland Security's decision.

"The politics are huge," says Slenning. "There will be all kinds of levels of political pressure on DHS and others to gain influence."

Not coincidentally, the five finalists have Republican connections and/or high-placed lawmakers on key, related committees.

For example, Mississippi Gov. Haley Barbour was a former Republican Party Chairman; Georgia Gov. Sonny Perdue served as state chairman for Bush's 2000 campaign; Texas is Bush's home state; Bush gave a speech on the global war on terror at Kansas State University in Manhattan last year. (Alas, Kansas may lose points because U.S. Sen. Sam Brownback openly criticized Bush's illegal warrantless wiretapping program.)

As for North Carolina, its lawmakers also have inroads into security and biodefense issues. Loyal Republican Sens. Richard Burr and Elizabeth Dole are biodefense proponents; Dole serves on the Armed Services Subcommittee on Emerging Threats and Capabilities.

In the House, U.S. Rep. David Price chairs the Appropriations Subcommittee on Homeland Security; his Democratic colleague, U.S. Rep. Bob Etheridge, serves on the Agriculture and Homeland Security committees.

Homeland Security is expected to announce its site selection in late 2008; construction is scheduled to begin in 2009, with completion estimated in 2012-13.

So far, there has been no organized public opposition to siting the proposed facility in Butner, although as Homeland Security surveyed 29 potential sites over the past year, citizens protested in Kentucky, Wisconsin, Missouri and California. None of those sites is a finalist.

"We haven't had any bad public reaction. We've received some concerns, and rightfully so," says Slenning. "Our primary concern is safety. When the [Homeland Security] site team was here in May, they were told by the private sector in the biotech industry that North Carolina will walk away from anything they don't like."


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