An assessment of potential contamination, exposure, and policy relating to large-scale production and purification of HIV-1

The epidemic of the acquired immunodeficiency syndrome (AIDS) has led to intense concern among health care workers about the risks they face in their work environment. Although there is much known about safety in the health care profession, very little work has been done in the area of occupationally-acquired infections in this workplace. The risk associated with a subpopulation of this workforce, i.e., laboratory personnel (specifically those involved in large-scale HIV-1 production and purification), was the focus of this project. In addition, relevant legislative and public policy issues were examined to determine the extent to which such issues address the protection of workers in these environments.;Sodium fluorescein, a physical tracer, was used to identify and quantify the potential for environmental contamination and/or worker exposure routes resulting from any inadequacies in design, engineering controls, or work practices during large-scale HIV-1 production/purification. Experimental results revealed that contamination occurred on the surfaces of equipment and work areas during laboratory procedures, and that this contamination is principally associated with manual procedures such as disconnecting tubing, decanting media and homogenizing cell packs. In addition, a greater amount of contamination and a greater variety of contamination sources were associated with those production/purification processes where the overall concentration of virus (infectious particles/ml) was lowest, such as roller bottle harvesting.;While the quantitative results of this study cannot be equated to potential exposure dose or probability of infection (should an exposure occur), they do underscore the need to identify sources of contamination in such laboratories, and recognize that usual Biosafety Level 3 practices and procedures may be inadequate for comprehensive worker protection. Results also revealed the need to implement additional safe work practices, and eliminate some common equipment use, to further reduce potential contamination sources.;Further, the experimental results of this study indicate that the OSHA Proposed Rule, "Occupational Exposure to Bloodborne Pathogens" (29 CFR 1910.1030), should include additional criteria for periodic assessment of equipment and processes to ensure effective regulatory protection of laboratory workers engaged in large-scale production of HIV-1. While basic biosafety requirements are addressed by the proposed legislation, there are no requirements for identification of contamination sources such as those found in this study.