Abstract
The goal of this project is to identify and characterize the types of incidents, accidents, exposures, and subsequent infections involving recombinant DNA materials that have occurred since the inception of biotechnology and oversight by NIH from June 1976 through December 31, 2010, a period spanning approximately 35 years of recombinant DNA research. A total of 197 records were identified by NIH/OBA describing incidents, accidents, exposures, or laboratory-acquired infections (LAIs) from 88 NIH-funded institutions reporting. These data were provided over a 3-year period from NIH through several FOIA requests and included all documentation in support of notification to NIH through resolution by the entity of a laboratory incident, accident, exposure, or LAI and constituted 3,045 pages of documentation. These data were collected using the REDCap data collection tool. A number of descriptive and inferential statistical analyses were completed. One hundred and thirty-nine (139) occupational exposures were reported involving 42 different biological agents that resulted in a total of 14 LAIs, all of which were self-limiting or easily treated, with a 79% known source of exposure, and none of which resulted in a single recorded mortality. The greatest number of occupational exposures occurred while working with lentivirus (21), followed closely by vaccinia virus (19), and then adenovirus (15). Of the 19 occupational exposures to vaccinia virus, over 50% resulted in a laboratory-acquired infection, some of which were caused by recombinant viruses. In addition, all of the vaccinia-related laboratory-acquired infections were in exposed individuals who had not been previously vaccinated. The lentiviral and adenoviral exposures, together 36/139 (26%), resulted in only one laboratory-acquired infection, and this was from a wild-type adenovirus and not a recombinant virus.