Top Panel Warns Biosafety, Security Regulations Could Be Hindering Science

Michael Pentella, Michael St. Clair and Thomas Sack

A panel of top laboratory administrators at a AAAS briefing warned that expanding already-extensive biosafety and security regulations intended to reduce the risk of bioterrorism could be hindering important public health research.

Speaking 12 March at a luncheon for reporters, the panel said that while the regulations—put in place before the 9/11 attacks, with periodic adjustments since then—have helped secure dangerous pathogens, they have placed an undue burden on researchers whose work could be used to reduce the effect of a bioterrorist attack.

"While they clearly serve a vital purpose, some aspects of these regulations and the inspection schedule have become excessive without providing additional security or safety benefit," said Tom Sack, regional vice president of Midwest Operations at the Midwest Research Institute. "This could be taking time away from research in the public interest."

While several federal agencies visit his facilities independently every year, Sack suggested the government should create a coherent inspection regime that brings all of the inspecting agencies to his facility at once, reducing the repetitive costs and lost time to his facility.

Sack spoke alongside Michael St. Clair, senior director for environmental health and safety at Ohio State University, and Michael Pentella, representing the Association of Public Health Laboratories and associate director for infectious disease testing at the University of Iowa Hygienic Laboratory, at the event co-sponsored by AAAS and the Center for Media and Security at the Fairmont Hotel in Washington D.C.

Kavita Berger, project director at the AAAS Center for Science, Technology, and Security Policy, said that the regulation of biological laboratories has become a prominent issue for Congress in recent years, with controversies over biosafety lapses at Texas A&M University in 2006 as well as prosecutions for mishandling pathogens under the U.S. PATRIOT Act.

Following the FBI's assertions that Bruce Ivins, an army scientist, was responsible for the anthrax attacks of 2001, additional congressional inquiries have touched on personnel reliability and the oversight of scientists working with dangerous pathogens.

"It's important that as legislators evaluate laboratory guidelines, they seek comments and experiences from those on the ground, on what works and what is broken with the system," said Berger. "Everyone wants to make sure that regulations are making the public more secure, and not restricting important public health research."

Sack said that his organization, a nonprofit government contractor that performs national defense, food safety, energy, and public health research, has three laboratories that work with select agents—pathogens identified by the U.S. government as being among the most dangerous.

In order to perform vital public health research which includes developing methods for detecting anthrax, making vaccines, and performing research on avian influenza, Sack said that his organization must be federally registered to work with select agents and inspected by several different agencies.

Sack estimates these inspections cost $50,000 in personnel and lost productivity each time one of several regulatory agencies examines their facilities. The $50,000 does not include the costs to ensure that his institution's biosecurity and safety compliance "is maintained at a high level," including physical security permits, and background checks on employees.

In addition, he said that each of the agencies—the Centers for Disease Control and Prevention, the U.S. Department of Agriculture, the Department for Homeland Security, and others—have their own methods for how inspections are conducted and the regulations are interpreted.

St. Clair said that it is important for federal officials to ensure that regulations are not so restrictive as to cause a brain drain, driving top researchers in the United States who want to work with select agents to other countries with fewer regulations. The United States is the only country that has a select agent program.

While St. Clair emphasized that this has not yet occurred in his university, he echoed Sack by calling for a "harmonization approach to regulation." He added that increased "training resources and continued inclusion of all stakeholders in the development of new regulations was paramount to establishing workable solutions to the issues facing us."

Pentella, who said public health laboratories work on the front lines of infectious disease testing, said that the complexity of working in a laboratory has increased greatly over the last century, as working with tuberculosis bacteria several decades ago required little physical security. Despite not being labeled a national security threat, and therefore, not on the select agent list, working with the tuberculosis bacteria now requires a Level 3 Biosafety facility to protect laboratory workers and the environment.

Pentella said that proper training of employees is critical to maintaining a safe and secure laboratory, in addition to doing regular audits of pathogen storage.

"Training is key," he said.

Gigi Kwik Gronvall

Gigi Kwik Gronvall, senior associate at the Center for Biosecurity at the University of Pittsburgh, which sponsored an earlier Capitol Hill briefing with the speakers, said that federal legislators must balance security measures with the progress of science, as regulations are already hampering the ability of U.S. scientists to collaborate internationally.

Gronvall called on the Department of Health and Human Services to reevaluate its list of pathogens labeled as select agents, as not all of the pathogens on the list are of equal importance to security or of equal danger.

In addition, Gronvall said that all 80 select pathogens, except two, exist in the real world outside the laboratory; two dozen domestic bison owned by media mogul Ted Turner died of naturally occurring anthrax in 2008. It is not physically possible to secure all of the select pathogens around the world, she said.

"At the end of the day, we need our scientists to be able to do their work in the laboratory," she said, calling for more attention to national preparedness. "The antibiotics to be used for a potential natural outbreak or terrorist attack won't make themselves."

Benjamin Somers

23 March 2009