WASHINGTON -- The federal government should not apply personnel security measures used widely at U.S. nuclear facilities to the nation’s bioresearch laboratories, according to a recently published experts’ report (see GSN, March 19).
(Jun. 9) -
Security breaches reported at facilities including the U.S. Army Medical Research Institute of Infectious Diseases, shown above, have prompted official and independent reviews of security practices at U.S. biological defense laboratories (Getty Images).
A major influx of funding for biodefense activities in recent years has produced greater concerns about the growing number of facilities and personnel conducting research with potentially lethal disease materials. This has led for calls from some sectors for increased regulation of such establishments.
Before instituting new requirements for nongovernment research institutions, Washington should “consider existing employment and biosafety training practices … as they may already contribute to vetting of personnel” and prevent “malicious actors or unstable personnel” from gaining access to pathogens that could be used in acts of bioterrorism, a new report by the American Association for the Advancement of Science recommends.
The May 29 study, titled “Biological Safety Training Programs as a Component of Personnel Responsibility,” was conducted by two units within the association. More than two dozen experts in biosafety, biosecurity and the life sciences, along with architects and engineers, participated in a March workshop that formed the basis of the report.
"We wanted to get the message across [in this report] as to how we thought the government should be thinking about that," Mark Frankel, head of the association's Program on Scientific Freedom, Responsibility and Law Program, said in a press release. "We wanted to be sure the hammer wasn't coming down when it really wasn't needed."
The study instead calls for greater government funding for safety training at research institutions and urges the facilities themselves to enact training requirements on their personnel.
As of February, 336 entities had registered to work with select agents through the Centers for Disease Control and Prevention and the Agriculture Department’s Animal and Plant Health Inspection Service, according to the association’s report. Those entities are spread throughout the government, academia and the private sector. The number of researchers and support staff registered to work with those materials now totals more than 14,600, the AAAS report says.
The number of U.S. high-containment laboratories -- those that handle disease agents for which there are no existing countermeasures -- has risen from five to 15 since 2001.
Some skeptics question whether the threat of bioterrorism outweighs the risk of establishing new facilities -- some in urban areas -- that handle anthrax and a host of other potentially lethal disease-causing materials (see GSN, April 16).
Proponents counter that the sites conduct research that would strengthen defenses against biological threats, whether they occur naturally or arise through intentional acts. They argue that the biosafety and biosecurity measures in place at the facilities are sufficient to prevent trouble.
Biosafety is generally defined as safety measures intended to prevent the release of infectious agents within a laboratory or the outside environment. Biosecurity involves more active methods to avert biological terrorism or other disease breakouts.
A number of incidents have provided fuel for those with worries about biosafety and biosecurity. The federal government levied a $1 million fine against Texas A&M University when it did not notify authorities that researchers had been exposed to -- and in one case, infected by -- infectious agents. Federal authorities identified the perpetrator of the 2001 anthrax mailings as a researcher at the Army biodefense site at Fort Detrick, Md. (see GSN, Jan. 6).
Such occurrences have produced a flurry of activity, including congressional inquiries and legislative proposals. The Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism last year recommended mandatory biosafety training for all life scientists and in January then-U.S. President George W. Bush issued an executive order calling for an interagency review of biosecurity at government laboratories, including personnel reliability. The policy recommendations from that review will be released next month.
In February, Senators Ted Kennedy (D-Mass.) and Richard Burr (R-N.C.) reintroduced legislation aimed at increasing the safety and security of facilities that handle materials that could be used in acts of bioterrorism (see GSN, Feb. 27). The bill calls for relevant government agencies and independent experts to develop minimum biosafety and biosecurity training procedures for personnel at BSL-3 and 4 facilities. Sites that failed to provide the minimum level of training would be banned from working with select agents.
While the government does not have authority over private sites, a large portion of the industry voluntarily obeys federal guidelines, according to a source within the bioresearch field.
Personnel reliability programs traditionally have been used to evaluate whether an individual is trustworthy enough to work with sensitive material or technology at the Lawrence Livermore National Laboratory in California and other sites. Those programs -- employed by Defense and Energy departments, among others -- can include psychological screening, drug and alcohol abuse testing, background investigations, polygraph testing, credit checks and top-secret clearances, the study says.
“There are some lessons that can be learned from the nuclear field but we’re talking about a different culture here and different agents. The bigger difference being the agents,” according to Kavita Berger, project director at the AAAS Center for Science, Technology and Security Policy and co-leader of the new biosafety study. Biological researchers work with “things found in nature that aren’t inherently national security risks, but global health problems.”
Berger noted that when nuclear research started it focused on weapons rather than power, while biological research provided a “clear function” that was not security-based. Those distinct missions lead to a difference in the research cultures with nuclear programs requiring more security.
The United States has not had a biological weapons program since President Richard Nixon renounced such activity in 1969, Berger said. Research today is focused on health issues and biodefense. To “retrofit” nuclear-style personnel security measures over existing bioresearch facilities would not be cost effective, she said.
It is “hard to see how it would be feasible and would not hinder scientific advancement,” Berger argued.
She also noted the recent recommendations by the National Science Advisory Board for Biosecurity, which found no need for the establishment of a formal national personnel reliability program for high-containment facilities. Such a program “is likely to have unintended and detrimental consequences for the scientific enterprise that could result in more harm to public health and safety and to national security than an inside threat poses,” according to that report.
There is a growing concern that too much emphasis on safety and security will “hurt the research enterprise as a whole,” according to Thomas Ksiazek, a visiting professor at the Galveston National Laboratory at the University of Texas Medical Branch. The increased burden for training and credentialing might turn some scientists away from such work, he said.
Institutionalized security programs based on nuclear efforts would also put a “burdensome emphasis” on laboratory inventory, requiring some sites to spend months “counting vials” and their contents, according to Ksiazek. Trying to exact that amount of control is “nonsensical” because “plutonium doesn’t make new plutonium atoms; microorganisms are multiplying entities,” he said.
Ksiazek said the report’s authors tried to achieve a balance between measures that are so demanding they have “very untoward” effects on the ability to perform research and not wanting to seem as being unresponsive to current “political pressures.”
He suggested the life sciences research community adopt a “tiered system,” one directly linked to the select agents list, that would tie the amount of training and security required for personnel to the potential threat of the material in question.
“The law is untiered. There has to be some differential with the risk associated with the organism,” Ksiazek said.
Berger said a consensus is forming around a tiered system approach to select agents but that there are still questions about how such a program would be implemented. She said it would be “interesting” to see if the concept is mentioned in the upcoming executive order’s policy recommendations when they are released next month.
The National Academy of Sciences is expected to release a study in September focused on personnel assurance, Berger said. That document should “inform the implementation, but not the development, of policy” that might stem from the executive order’s policy recommendations, according to Berger.
The association’s report urges the federal government to allocate funds to research institutions for initial and ongoing biosafety training, “applied biosafety research” and maintenance of high-containment laboratories. Experts recommended that the biosafety community create a “national, anonymous database of exposures” so that biosafety professionals and administrative personnel can benefit from lessons learned at sites that have experienced mishaps.
The report makes eight recommendations regarding training, urging senior scientists to "continually" mentor laboratory personnel regarding safe operations in high-containment laboratories and calling for programs to institute "performance-based training standards developed from a set of core competencies that are critical for working" in such facilities. Participants also recommended that research institutions provide “realistic information” about the hazards that exist in a high-containment facility to the local community’s emergency responders to help guide their response in the event of an emergency.
The experts identified a number of biosafety programs at institutions around the United States, along with "train the trainer" efforts at Emory University in Georgia and elsewhere that help personnel promote biological safety at their respective employers.