of standard precautions and other measures required by the Occupational Safety and Health Administration bloodborne pathogens standard (29 CFR § 1910.1030) (NIOSH 1999).
In sum, the Fort Detrick experience, the data provided by DSAT, and reviews of recent laboratory incidents demonstrate that exposures to infectious pathogens, and LAIs, can occur even in the most highly regulated research environments where high-risk pathogens, such as Select Agents, are handled. Although the data indicate substantial progress in biosafety since the 19th century, the committee concluded that immunization remains a valuable and necessary additional safeguard in the practice of safe science.
A variety of important lessons learned from these experiences have helped to shape the field of biosafety and safe laboratory practice:
When a pathogen or toxin that may cause disease is studied in the laboratory, it is logical to expect that sooner or later some laboratory worker will become infected with it.
Class III BSC systems can operate without LAIs in whole-body and head-only aerosol studies that use repetitive procedures with stable, well-trained, and well-disciplined workers.
Research using repetitive procedures is less hazardous than research requiring frequent changes in technique and equipment.
Pathogens with low infective doses (such as F. tularensis, VEE, C. burnetii, and B. melitensis) increase the risk of infection from aerosol exposures.
In the absence of effective immunization, it is not possible to do basic research using Class I BSCs with a highly infective pathogen without LAIs. As a result of advances in biosafety equipment, research with highly infective pathogens is conducted with other types of BSCs (e.g., Class II and Class III BSCs).
Analysis of disease surveillance data and lessons learned can provide guidance for making improvements in safe laboratory practices, research protocols, and the use of containment equipment.
Current biodefense research to satisfy FDA requirements under the animal rule for product licensure (discussed further in Section 4.2.3) will require frequent animal inoculation and aerosol experiments to test the efficacy of biodefense vaccines and other medical countermeasures. That research will probably present an increased risk of exposure of laboratory workers.