Chapter 10 covers the administrative and legal aspects of biosecurity, which include international treaties, laws, statutes, regulations, and government directives aimed at reducing the threat due to the biological agents and enabling enforcers to deal with those that use them with ill intentions. These administrative measures have helped define programs and strengthen biodefense and biosecurity all over the globe. The aim of this chapter is to discuss the most relevant documents in hopes that the reader will appreciate the authority and framework given to officials by these measures. The chapter is not written for legal professionals. Rather, it is written for emergency management and public health professionals that may have to apply the rules of law in everyday situations. Care should be taken to consult a legal professional before utilizing any of the concepts related to public health law.
New construction of biosafety level 3 (BSL-3) laboratories in the United States has increased in the past decade to facilitate research on potential bioterrorism agents. The Centers for Disease Control and Prevention inspect BSL-3 facilities and review commissioning documentation, but no single agency has oversight over all BSL-3 facilities. This article explores the extent to which standard operating procedures in US BSL-3 facilities vary between laboratories with select agent or non-select agent status. Comparisons are made for the following variables: personnel training, decontamination, personal protective equipment (PPE), medical surveillance, security access, laboratory structure and maintenance, funding, and pest management. Facilities working with select agents had more complex training programs and decontamination procedures than non-select agent facilities. Personnel working in select agent laboratories were likely to use powered air purifying respirators, while non-select agent laboratories primarily used N95 respirators. More rigorous medical surveillance was carried out in select agent workers (although not required by the select agent program) and a higher level of restrictive access to laboratories was found. Most select agent and non-select agent laboratories reported adequate structural integrity in facilities; however, differences were observed in personnel perception of funding for repairs. Pest management was carried out by select agent personnel more frequently than non-select agent personnel. Our findings support the need to promote high quality biosafety training and standard operating procedures in both select agent and non-select agent laboratories to improve occupational health and safety.
Computational models describing bacterial kinetics were developed for inhalational anthrax in New Zealand white (NZW) rabbits following inhalation of Ames strain B. anthracis. The data used to parameterize the models included bacterial numbers in the airways, lung tissue, draining lymph nodes, and blood. Initial bacterial numbers were deposited spore dose. The first model was a single exponential ordinary differential equation (ODE) with 3 rate parameters that described mucociliated (physical) clearance, immune clearance (bacterial killing), and bacterial growth. At 36 hours postexposure, the ODE model predicted 1.7×10⁷ bacteria in the rabbit, which agreed well with data from actual experiments (4.0×10⁷ bacteria at 36 hours). Next, building on the single ODE model, a physiological-based biokinetic (PBBK) compartmentalized model was developed in which 1 physiological compartment was the lumen of the airways and the other was the rabbit body (lung tissue, lymph nodes, blood). The 2 compartments were connected with a parameter describing transport of bacteria from the airways into the body. The PBBK model predicted 4.9×10⁷ bacteria in the body at 36 hours, and by 45 hours the model showed all clearance mechanisms were saturated, suggesting the rabbit would quickly succumb to the infection. As with the ODE model, the PBBK model results agreed well with laboratory observations. These data are discussed along with the need for and potential application of the models in risk assessment, drug development, and as a general aid to the experimentalist studying inhalational anthrax.
Increasing threats of bioterrorism and the emergence of novel disease agents, including the recent international outbreaks of H7N9 influenza and MERS-CoV, have stressed the importance and highlighted the need for public health preparedness at local, regional, and national levels. To test plans that were developed for mass prophylaxis scenarios, in April 2013 the Cook Country Department of Public Health (CCDPH) and the Triple Community (TripCom) Medical Reserve Corps (MRC) executed a full-scale mass prophylaxis exercise in response to a simulated anthrax bioterrorism attack. The exercise took place over 2 days and included the TripCom Point-of-Dispensing (POD) Management Team, volunteers from the TripCom MRC, and neighboring public health departments and MRCs. Individuals from the community volunteered as actors during the exercise, while local municipal, police, and fire personnel coordinated their responses to create the most realistic simulation possible. The exercise was designed to test the capacity of TripCom and CCDPH to implement plans for organizing municipal staff and volunteers to efficiently distribute prophylaxis to the community. Based on results from POD clinic flow, accuracy of prophylaxis distribution, and observations from evaluators, the exercise was successful in demonstrating areas that were operationally efficient as well as identifying areas that can be improved on. These include improvements to the just-in-time training for POD staff, the health screening and consent forms handed out to patients, the physical setup of the POD, and the command structure and communication for the management of POD operations. This article demonstrates the need for full-scale exercises and identifies gaps in POD planning that can be integrated into future plans, exercises, and emergency response.
This study presents data showing the performance of 6 commercial detection assays against ricin around concentrations specified as detection limits by the producers. A 2-fold dilution series of 20 ng/ml ricin was prepared and used for testing the lateral-flow kits: BADD, Pro Strips™, ENVI, RAID DX, Ricin BioThreat Alert, and IMASS™ device. Three of the 6 tested field assays (IMASS™ device, ENVI assay, and the BioThreat Alert assay) were able to detect ricin, although differences in the measured detection limits compared to the official detection limits and false-negative results were observed. We were not able to get the BADD, Pro Strips™, and RAID assays to function in our laboratory. We conclude that when purchasing a field responder assay, there is large variation in the specificity of the assays, and a number of in-house tests must be performed to ensure functionality.
