Grand Challenges for Biosafety and Biosecurity

Success in combatting infectious diseases has saved more lives than any other achievement of medical science. The three greatest advances have been clean water, immunization, and the advent of antibiotics and, more recently, antivirals. Despite this record of success we are far from conquering the grand challenge to human health posed by microbes. All that has been achieved is the consequence of increasingly sophisticated research. Through advances in technology which have led to deep sequencing we are now able to identify previously undetectable bacteria and other microbes which had previously eluded our appreciation because of our inability to culture them. One of the consequences has been an increased understanding of the omnipresence of bacterial populations in the human body (Berg, 1996; Savage, 1977). We now estimate that the human body on average contains ten times as many bacterial cells as human cells. In addition, the human body probably contains at least ten times as many viral genomes as bacterial genomes. So we are very much a diverse biological community and it behooves us to gain as complete knowledge as possible if we are to continue to enhance human health. Because much of the research in this area involves study of microbial pathogens, there is potential risk for researchers in the laboratory. Additionally, there is the risk that dangerous microbes under study might escape from the laboratory and pose a risk to the public health. Although many of the microbes under study are normally present in the environment, in special cases the bacteria or viruses have natural or enhanced virulence not usually present in the environment and these are of especial concern. Pathogens have been classified with respect to the degree of risk they represent, both to lab workers and to the public. The assessment depends not only on the virulence of the microorganism, but also on whether an effective vaccine exists and/or effective antimicrobial therapy is available. Where an effective vaccine exists, laboratory workers should be immunized and precautions should be taken to physically contain the microbes under study. Depending on the assessed virulence, various levels of physical containment have been mandated. In the United States there are functionally four levels. Level one assumes no measurable risk and level four is for the most virulent pathogens for which no effective immunization or antimicrobial therapy exists. The U.S. Centers for Disease Control and Prevention (CDC) publishes a manual of the requirements for physical containment entitled