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U.S. Response: Scientists Readying for New Laboratory Regulations By David Ruppe They will be looking to see how the new regulations balance changing perceptions of security needs with openness in scientific research. “We … clearly are going to have a new biosecurity component of the regulations that we have not seen yet,” Ronald Atlas, president of the American Society for Microbiology, told a conference here yesterday. “The potential for misuse of scientific information is pitting national security concerns against traditional openness of biomedical research,” Atlas said. The regulations will be published as an interim final rule, as required by the Bioterrorism Preparedness Act, which became law in June (see GSN, June 12), and are scheduled for publication in final form in February, after a 60-day comment period. The act requires facilities possessing certain dangerous biological materials to provide the Justice Department the names of individuals with access to those agents for screening against criminal, immigration and national security databases. Previously, since 1997, federal law only required persons transferring restricted agents to notify the U.S. Centers for Disease Control before the agents are shipped. The regulations are expected to set out procedures for registering people and facilities dealing with such agents. Exemptions will be allowed for medical, clinical and diagnostic laboratories and for approved investigational products, White House Office of Science and Technology Policy Director John Marburger said in congressional testimony in October, giving a preview of the new regulations. Strengthened Security Measures Required The regulations also are expected to specify requirements for laboratories to increase security in ways relevant to the nature of the facility and the types of agents possessed. “Institutions will be required under the new regulations to prepare a comprehensive security plan based on threat analyses and risk assessments. The decision to purchase ‘guns, gates and guards’ should be thought through carefully and any security enhancements should be based on a thorough, professional risk assessment,” Marburger said. “We’re all going to have to consider how you don’t leave the door open for someone, how you have appropriate surveillance, how you have an inventory of what you do,” said Atlas. Atlas said he expects the regulations to require reporting to federal authorities of suspicious incidents. “This is new for the scientific community. Not a lot of my colleagues meet regularly with FBI agents. I think many will find this a new and challenging aspect of entering into biodefense,” he said. Impact on Research The Bioterrorism Preparedness Act implements a new government approach to biosecurity set out in the Patriot Act, passed in the wake of the Sept. 11 and subsequent anthrax terrorist attacks in 2001 (see GSN, May 9). The Patriot Act made it crime to knowingly possess any biological agent, toxin or delivery system that cannot be “reasonably justified” for prophylactic, protective, “bona fide” research or other peaceful purposes. Some scientists have expressed concern the new government approach to security could hamper civilian research using sensitive biological materials. A Massachusetts Institute of Technology panel produced a well-publicized report in June called In the Public Interest that argued against conducting classified research on campuses, requiring security checks of students seeking to perform thesis research and restricting foreign nationals with valid visas from access to courses, research or publications on campus (see GSN, June 14). “Openness enables MIT to attract, educate, and benefit from the best students, faculty and staff from around the world. This is especially important, as competence in science and technology has grown throughout the world so that access to research and knowledge outside the United States is critical to our own progress,” said MIT professor and former Air Force Secretary Sheila Widnall, also testifying in October. Widnall said Patriot Act requirements regarding personnel, students, faculty, and staff, “are not consistent with MIT’s principles. It is likely that in the current climate, the number of biological agents on the list will grow and the restrictions placed on personnel, physical access, and publication of research findings may grow as well.” In a high-profile application of the new law, the Justice Department this year was preparing to prosecute a University of Connecticut graduate student for retaining two vials of tissue samples from a cow that died of anthrax, he reportedly said, for possible future research. The student was charged with possessing anthrax “not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose” (see GSN, July 23). The charges were dropped in exchange for community service, but Atlas said the incident was intended by the Justice Department to “send a message” and has “led many of my colleagues to destroy cultures.” Atlas told Global Security Newswire he had no inherent problem with the Patriot Act requirement, saying rather that it requires interpretation in the courts so the civilian community can properly implement them. “The law set up an ambiguity that has to be interpreted. Saying that you have to have bona fide reason, that’s not going too far,” he said. The question, he said, is “how you interpret bona fide.” Question Over Consultation Altas’ organization has charged the Centers for Disease Control and the Agriculture Department with allowing civilian experts an insufficient opportunity to influence the new regulations. He appeared to reiterate that concern in his comments to the conference yesterday. “In theory, there is a 60-day comment period. In reality, if we follow the Bioterrorism Preparedness Act, it says the regulations will go into effect by the time we hit the end of the 60-day period,” he said. Marburger suggested in October the Bush administration was attempting to address concerns about scientific openness. “The administration is sensitive to the need to avoid erecting barriers to legitimate scientific research,” he said.
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