WASHINGTON -- Two veteran U.S. lawmakers have introduced legislation intended to reduce the likelihood of potentially disastrous accidents at facilities that handle lethal disease agents (see GSN, Feb. 21).
The bill from Senator Richard Burr (R-N.C.) and Senator Ted Kennedy (D-Mass.) followed a series of mishaps in recent years at biological defense research institutions, notably exposures of several Texas A&M staffers to Brucella and Q fever (see GSN, Sept. 20, 2007). It predated by less than two months the Justice Department's identification of U.S. Army microbiologist Bruce Ivins as the perpetrator of the 2001 anthrax mailings (see GSN, Aug. 7).
Among a host of legislative proposals addressing disease research safety and security are calls for improvements to oversight and training at Biosafety Level 3 and 4 laboratories, which can contain the most dangerous pathogens.
Burr and Kennedy are also seeking funding reauthorization through 2013 of the U.S. Select Agent Program, which sets rules for the 400 entities and more than 14,000 individuals authorized to hold, use and ship any of 72 agents and toxins that could pose significant health threats to humans, animals and plants. The list includes potential bioterrorism agents such as ricin, the smallpox virus, and the bacteria that cause anthrax and plague.
"Recent public attention to the 2001 anthrax attacks is a reminder of the importance of controlling access to certain dangerous biological agents and toxins that could be used for bioterrorism; our bill does just that," Burr said in a statement. "It reauthorizes and strengthens the Select Agent Program, which regulates the possession, use, and transfer of agents that pose a threat to public health and safety.
"We must remain vigilant in our efforts to protect the American people from bioterrorism," he added. "In this time of exciting scientific advances, we must ensure that our laws and prevention programs reflect current conditions."
The number of BSL-3 and 4 research laboratories has exploded in recent years as a response to the threats of bioterrorism and pandemic disease. How many "high-containment" sites are in operation remains unknown; two separate government reports in 2005 found that there were either 277 or more than 600 BSL-3 facilities in the United States. The Government Accountability Office last year counted at least 15 existing or planned Biosafety Level 4 sites -- those with systems intended to allow them to safely manage materials that cause fatal diseases for which there are no preventive countermeasures -- spread across the government, academic and private sectors.
The growing count of disease study facilities, and the rising population of researchers handling dangerous materials, creates an increased risk for potential exposures, according to some observers.
As one participant noted during a 2006 meeting organized by the University of Pittsburgh's Center for Biosecurity for discussion of biodefense research, "We're going to have all of these researchers who have crossed out plant' on their grants and written in anthrax' and have gotten funded."
"A lot of people are concerned in the community, and they should be," said Gigi Kwik Gronvall, a senior associate at the center, which is supporting the legislation. "These diseases are not worked in containment for no reason. Most laboratory accidents, if it causes an infection, it causes an infection in the worker. We wouldn't want that to be out of ignorance, especially since some of these diseases have no cure."
The Burr-Kennedy, legislation, the Select Agent Program and Biosafety Improvement Act, would address training, oversight and other issues raised by the center and the Government Accountability Office. It is now before the Senate Health, Education, Labor and Pensions Committee, awaiting lawmakers' return to Washington next month after the summer break.
Should the bill be approved, the heads of the Health and Human Services, Agriculture, Defense and Homeland Security departments within 240 days would be required to prepare an assessment of oversight issues at high-containment biological laboratories.
Oversight involves anything from ensuring equipment maintenance to unannounced inspections to verify that laboratories maintain current inventories of their pathogen samples, said Jean Patterson, virology and immunology chief at the Southwest Foundation for Biomedical Research, a BSL-4 site in San Antonio, Texas.
Issues for consideration would include whether there are enough high-containment sites to meet U.S. biodefense and infectious disease research needs, possible improvements in biosafety and biosecurity training, and how to best share lessons learned from the operation of existing facilities.
Biosafety is generally defined as safety measures 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.
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.
"When you had only a few people working in these areas, then they would train their people so that they could work safely in BSL-4," Gronvall told Global Security Newswire. "Now that there are so many more scientists that are going to be working in these conditions, there needs to be a way to standardize that training so that you can conserve these mentors' time and energy and bring everybody up to a certain level."
Increased attention by laboratory management in this area could serve to help identify a scientist who, like Ivins is alleged to have done, planned to misuse the dangerous materials found at a research facility, Gronvall said.
"I think training in safety, that confidence aspect, it's more interaction with the scientists, more checking of the work force, if they're prepared," she said "If that leads to more doubts about a worker's suitability for that type of work, then perhaps that's a good thing."
Burr and Kennedy are also pressing for the Health and Human Services and Agriculture departments to establish a reporting system for accidents or other "incidents of concern." An independent entity would analyze reports for possible trends and issue alerts as necessary. The reporters and the involved institutions themselves would not be publicly identified.
While Select Agent Program rules require reporting of laboratory accidents, "the almost accidents are not reported," Gronvall said.
Along with extending the Select Agent Program, the senators are requesting a National Academy of Sciences review of the initiative's affect on U.S. biosecurity and biosafety and its impact on scientific advancement and international research collaboration.
The Centers for Disease Control and Prevention, which regulates activity involving agents and toxins that could pose a threat to humans, would only say that it supported reauthorization of the program. The USDA Animal and Plant Health Inspection Service, which conducts the same work for disease material that poses a threat to animal or plant life, said it could not comment on pending legislation.
Representatives from several BSL-4 laboratories did not return requests for comment or said they could not discuss the bill before it was voted up or down.
Patterson, who was among the scientists who reviewed drafts of the legislation for the senators, said the bill proposes "common sense" regulations without restricting crucial biodefense research.
That balance remains important as long as the United States faces acts of biological terrorism or natural pandemic, Gronvall said.
"We do not have at the end of the day the drugs, vaccines we need for an anthrax attack or another biological weapon," she said. "Pretending there is not a vulnerability is not going to make it go away."