Biodefense Lab Update

Construction of a giant federal laboratory in Kansas to study the world’s most deadly and highly infectious animal diseases remains on track to begin next year, even though critics continue to voice concerns about the safety and cost of the nearly billion-dollar project.

President Barack Obama’s proposed fiscal 2012 budget includes $150 million in funding for the Department of Homeland Security (DHS) to begin construction of the National Bio & Agro-Defense Facility (NBAF), a 500,000-sq-ft germ research center that will employ about 350 scientists and become fully operational in 2018. It will be built on the campus of Kansas State University, in Manhattan, about 120 miles west of Kansas City.

Research at NBAF will focus on naturally occurring animal diseases such as classical swine fever and Rift Valley fever. Researchers say the studies can lead to development of effective vaccines and treatments and thereby help protect the nation from biological threats.

“Scientists at NBAF will conduct research critical to the safety of our nation’s food supply, and K-State researchers will provide vital collaborative work,” says Ron Trewyn, vice president for research at Kansas State. “Funding for the next phase of construction will put them one step closer to tackling threats to our food supply.”

Congress still needs to approve the Administration’s $150 million request. But funding the NBAF project “is one of our nation’s top security priorities,” says Thomas V. Thornton, president of the Kansas Bioscience Authority, a state agency that encourages bioscience investments in Kansas.

“We understand the difficult economic climate our nation faces today,” Thornton says. “That’s why we appreciate even more the resolve and commitment of DHS to fund NBAF. There is no question that a safe and secure food supply for every American is a national priority of the highest order.”

The proposed lab in Kansas would replace the aging Plum Island Animal Disease Center, which is located on an isolated 840-acre island a mile and a half off the northeastern tip of New York’s Long Island.

Since 1954, the U.S. Department of Agriculture (USDA) has been conducting research at the Plum Island facility on pathogens such as the live virus that causes foot-and-mouth disease, which is highly contagious to livestock and could cause catastrophic economic losses and imperil the nation’s food supply. The U.S. has not experienced an outbreak of foot-and-mouth disease since 1929, and research into the illness has not been permitted on the U.S. mainland since 1937.

Soon after the Sept. 11, 2001, terrorist attacks, however, security experts began voicing concern that the Plum Island lab, sitting between New York City and Boston, is an inviting target for terrorists. In September 2003, the Government Accountability Office (GAO), the investigative arm of Congress, declared in a report that there is a substantial risk that “an adversary might try to steal pathogens” from the facility and use them against people or animals in the U.S. (GAO-03-847).

The report noted that a camel pox strain researched at the center could be converted into “an agent as threatening as smallpox,” and the Venezuelan equine encephalitis virus studied there could be “developed into a human biowarfare agent.” GAO emphasized that the center “was not designed to be a highly secure facility.”

That same year, the recently established DHS assumed responsibility for the safety and security of Plum Island, and the agency initiated plans to find a new location for a larger, highly secure modern facility that would allow research on zoonotic diseases—those that can be passed from animals to humans—for which there is no cure or vaccine, something currently not done at Plum Island.

After a three-year search that took into account risk, environmental impact, and security assessments, DHS announced in January 2009 that it had selected Manhattan, Kan., over other prospective sites in Athens, Ga.; Madison County, Miss.; Granville County, N.C.; and San Antonio.

The Kansas State site offers proximity to the university’s research facilities and to veterinary and agriculture colleges, and it is near the concentration of animal health companies clustered around Kansas City, DHS explained. That the site is also in the middle of the country’s agricultural heartland is potentially helpful for rapid diagnosis of foreign animal disease in food animals, the department added.

NBAF would be the world’s third “biosafety-level 4” pathogen laboratory that could work with large animals, such as cattle and swine. The other two facilities are in Australia and Canada. Biosafety facilities rated BSL-4 are designed to contain the most dangerous organisms known to humans, such as Ebola, the virus that causes hemorrhagic fever, and Bacillus anthracis, the bacterium that causes anthrax.

Congress included $32 million in the fiscal 2010 Homeland Security Appropriations Act for planning and design work on the new laboratory, which is now expected to cost as much as $915 million by the time it is completed.

However, lawmakers prohibited the use of federal funds for the construction of NBAF until a thorough study of the risks of locating the facility at Kansas State was conducted by DHS and reviewed by the National Research Council (NRC), an arm of the National Academies.

DHS’s risk assessment concluded that the Kansas location is safe. But last November, an NRC panel sharply criticized the agency’s analysis, saying it contains “several major shortcomings,” including overly optimistic projections about the risk of release and infection at the facility (C&EN, Nov. 22, 2010, page 7).

The NRC report found that the DHS assessment was “not entirely adequate or valid” and “did not account for the overall risks associated with operating the facility in Manhattan, Kan., nor did it account for the risks associated with work on the most dangerous pathogens in a large animal facility.”

The research council noted that DHS estimates an “extremely low,” 2% chance each year that a pathogen could be accidentally released from the laboratory. However, on the basis of DHS figures, NRC calculates there is a 70% chance a pathogen would escape and cause an infection during NBAF’s planned 50-year operational life span.

This is a “level of risk that cannot be considered low,” NRC concluded, pointing out that between 1960 and 2007, the foot-and-mouth disease virus escaped at least 15 times from laboratories worldwide.

The DHS study also projects that the economic losses from a foot-and-mouth disease outbreak would range between $9 billion and $50 billion. But the NRC analysis states that the actual amount could be “significantly higher.” NRC notes that the risk of widespread disease would be greater in Manhattan because nearly 10% of the entire U.S. cattle inventory lies within a 200-mile radius of the proposed facility.

“Given that the disease is highly contagious and that the chance of its escape is not zero, rigorous and robust mitigation strategies that address an extensive outbreak of foot-and-mouth disease are needed before the facility opens,” the report recommends.

DHS spokesman Chris Ortman says NRC’s calculation of a 70% chance for a potential disease outbreak “was based on a notional facility and did not account for any of the recommended mitigation measures that DHS has committed to incorporating into the final design. DHS will not build or operate NBAF unless it can be done in a safe manner.”

Kansas State’s Trewyn maintains that NRC’s analysis “exaggerates risk to an extreme, nonsensical level that would call into question the entire American biocontainment research enterprise,” including at the federal Centers for Disease Control & Prevention in Atlanta.

Modern research methods and facilities “are extremely safe and urgently needed,” Trewyn adds. He points to a lab just across the border from North Dakota in Winnipeg, Manitoba, where scientists study the foot-and-mouth disease virus, noting that “foot-and-mouth disease research is already conducted on the mainland and has not spread to livestock outside the facility there.”

Despite its criticisms, the NRC panel does not question the need for an alternative to the Plum Island facility, which is old and in need of repair. “We need a facility like the proposed NBAF,” says Ronald Atlas, a professor of biology and public health at the University of Louisville and chair of the committee that wrote the report.

“The report makes no judgment on whether the Kansas location is an appropriate site for the proposed facility or on what risk is acceptable to society,” Atlas says. “Those questions are left to policymakers and future risk assessments.”

Rep. Timothy H. Bishop (D-N.Y.), whose district includes Plum Island, says the safety concerns and high costs associated with transferring the research to Kansas should dissuade federal officials from going forward.

“The NRC report confirms that DHS has not properly accounted for the significant risk that a dangerous animal pathogen could escape from NBAF into the heart of cattle country, with devastating consequences,” Bishop says. “DHS also has not properly accounted for the cost of the facility, which is spiraling toward a billion dollars.”

As part of his effort to derail the project, Bishop last month offered an amendment to a spending bill (H.R. 1) that would have prohibited Congress from appropriating any money in the current fiscal year to advance the construction of NBAF. But lawmakers demonstrated their support for the facility and its location on the mainland by defeating the amendment by a vote of 269 to 156.

“NBAF, in my view, is a government boondoggle that anyone concerned about fiscally responsible behavior should want to be stopped,” Bishop declared on the floor of the House of Representatives on Feb. 18 during the debate on his amendment.

He noted that the federal government plans to sell Plum Island to largely offset the cost of building the new lab. But as the Long Island congressman pointed out, the island has been valued at $50 million to $80 million, whereas NBAF’s price tag has more than doubled from DHS’s original projection of $451 million.

Even if a buyer is found, Bishop said, DHS would still be responsible for cleaning up Plum Island, which was originally used as a military installation and ammunition dump. The Army ran the site as Fort Terry from 1897 until after World War II. The U.S. Army Chemical Corps had jurisdiction from 1951 to 1954, when it was officially deactivated and acquired by USDA.

“Given our nation’s mounting budget deficits, we should not invest one more dollar of taxpayer money—and up to $1 billion—to create a massive new research facility that would duplicate many of the functions currently served well by other existing facilities, including Plum Island,” Bishop argued.

But Rep. Lynn Jenkins (R-Kan.), whose district would include the new facility, asked her colleagues during the amendment debate to support the project “so we can safely conduct critical research to develop vaccines and countermeasures in order to protect the public and our livestock from the threats of devastating diseases.”

The U.S., she said, is “dangerously underprotected” from the threat of a biological attack. “Our security is at risk, and delaying this project further because the gentleman from New York would prefer to preserve a stunningly outdated lab that just so happens to be in his district, is not an option,” Jenkins argued. “We need to move forward. We need NBAF.”

Despite the setback, Bishop will continue his efforts to bar funding for the facility in future appropriations bills, including the fiscal 2012 DHS spending bill, a spokesman for the congressman tells C&EN.

But Kansas officials say the research mission for NBAF is too important for it to become a political fight in Congress.

“Protecting our food supply and our place as the world’s leader in science and technology hinges on continuing projects such as NBAF,” Sen. Pat Roberts (R-Kan.) remarked last month at a USDA symposium on biosafety.

“Without a safe and secure facility, we leave our livestock and our agriculture at great risk. This is a risk I am unwilling to take,” Roberts said. “We must protect our nation and its people, economy, and food supply. Only by building an NBAF can we adequately do this.”