The installation of hands-free sinks is first required for which biosafety level?
| September 14, 2018 Biosafety Level 2 Plus (BSL-2+) is the common term for laboratories where work with microorganisms is conducted in a BSL-2 laboratory with biosafety practices and procedures that are typically found at BSL-3. The need for this hybrid approach is on the rise in recent years due to increased research with viral vectors, arboviruses, and other emerging infectious diseases. But implementation can be challenging due to the fact that it is not a recognized containment level, so no clear prescription for implementation is available. Most research institutions that could benefit from this hybrid approach struggle to determine when it is safe and appropriate to use it and which BSL-3 practices to use. BSL-2+ Safe Implementation in the Research EnvironmentBSL-2+ is not a recognized containment level in biosafety guidance documents such as the Centers for Disease Control and Prevention’s (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL) or the National Institutes of Health’s (NIH) Guidelines for Recombinant and Synthetic Nucleic Acid Molecules. Other biosafety guidance documents such as the NIH’s Biosafety Considerations for Research with Lentiviral Vectors refer to “enhanced BL2 containment” (another term for BSL-2+) but do not detail how to implement it. It is important to know that BSL-2+ is not appropriate for pathogens that are infectious via the inhalation route in the research setting. At a minimum, such pathogens must be utilized in a BSL-3 laboratory with BSL-3 practices. Clinical laboratories have different needs and challenges, for more on this you can read our post, Clinical Laboratories: Using BSL-2 Plus When Working with Pathogens Transmitted via Inhalation. To determine if your research can be safely conducted in a BSL-2+ environment, you must conduct a risk assessment. Critical First Step: Conducting a Risk Assessment to Identify Biosafety Level and PracticesBSL-2+ is used when a pathogen is determined to require BSL-2 physical containment using safety practices over and above the practices required at BSL-2. There is no standardized list of microorganisms, viral vectors or research projects that should be conducted at BSL-2+. To determine if BSL-2+ is suitable for your research you must first conduct a risk assessment in accordance with the process defined in the BMBL. The risk assessment guides the selection of appropriate biosafety levels and microbiological practices, safety equipment, and facility safeguards that will contribute to preventing a laboratory exposure. As outlined in the BMBL, the steps of the risk assessment process include:
The risk assessment process must be conducted for every new or revised research project. Examples of when BSL-2+ may be appropriated include:
Project Review Process The project review process is part of the risk assessment and includes these steps that must be completed before work can be approved and begin:
Selecting a Laboratory Space for BSL-2+Often academic and research BSL-2 laboratories are large spaces occupied by many lab personnel working on a variety of projects and sharing lab equipment. In some cases this may not be conducive to adhering to BSL-3 practices. For this reason a separate BSL-2 laboratory space may need to be dedicated to the project that requires BSL-3 practices. Practically speaking this usually means taking a smaller BSL-2 or “tissue culture” laboratory room and dedicating it to the project. This allows access to be limited to only those people who have received the necessary training and are listed on the research protocol. BSL-2+ Safe Implementation in the Research EnvironmentSelecting and Modifying BSL-3 PracticesIt is important to keep in mind the BSL-3 requirements for work practices and safety equipment such as personal protective equipment (PPE) and BSCs. Sometimes the appropriate BSL-3 practices determined by the risk assessment may be limited to restricting sharps in the laboratory. In other situations, multiple BSL-3 practices are selected. Each risk assessment and project review should include a review of these practices and equipment requirements to determine the items that will protect workers and the surrounding community. Each item may be subject to discussion and there is room for adjustments, provided there is consensus among the IBC members. Other Issues to Consider When Implementing BSL-2+ PracticesOften there are other issues that should be given careful consideration and reviewed such as:
The use of BSL-3 practices in a BSL-2 laboratory may be appropriate for some research projects and may contribute to the safe conduct of that research. Since there is no “one size fits all” approach, the risk assessment is key to determining whether BSL-3 practices are appropriate in a BSL-2 lab facility and what practices will be required. Strong collaboration between the PI, BSO, IBC and lab personnel is also crucial to the successful outcome. For more information on implementing a BSL-2+, download our guide that includes illustrative case
studies. If you need help determining if a BSL-2+ is right for your research needs and how to implement it, contact us today! In 2012, EH&E conducted a survey of academic, biotechnology and healthcare institutions to gain insight into how institutions managed implementation of BSL-3 practices and procedures in the BSL-2 environment and the drivers for using this approach. The survey results were published in an EH&E white paper originally authored by Elizabeth Gilman Duane, MS, RBP, CBSP. That paper was the basis of a published article in Applied Biosafety (cited below), which is the original source of information for this blog. In 2018 this blog was updated by Theodore A. Myatt, Sc.D., M.E.M., and Anthony J. Troiano, Jr., PH.D., RBP, of EH&E. Gilman Duane E. 2013. A Practical Guide to Implementing a BSL-2+ Biosafety Program in a Research Laboratory. Applied Biosafety: Journal of the American Biological Safety Association, 18(1):30-36. What are the 4 levels of biosafety?The four biosafety levels are BSL-1, BSL-2, BSL-3, and BSL-4, with BSL-4 being the highest (maximum) level of containment. There are additional specific rules and designations for animal research (ABSL), agricultural research (BSL-Ag), and other types of research.
What is a Containment Level 1 laboratory?Containment level 1 (CL 1) is used for work with low risk biological agents and hazards, genetically modified organisms, animals and plants.
What is a containment level 2 laboratory?Containment level 2 (CL 2) is used for work with medium risk biological agents and hazards, genetically modified organisms, animals and plants.
What are Level 4 pathogens?Biohazard Level 4 usually includes dangerous viruses like Ebola, Marburg virus, Lassa fever, Bolivian hemorrhagic fever, and many other hemorrhagic viruses found in the tropics.
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