Section II – Biological Risk Assessment

Section II: Biological Risk Assessment (Hazardous characteristics of an agent, Hazardous characteristics of lab procedures, potential hazards associated with work practices, safety equipment and facility safeguards, an approach to assess risks and select appropriate safeguards)

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16 Comments

  1. Anonymous's Gravatar Anonymous
    May 13, 2016    

    To the extent possible, add a Risk Assessment flow diagram depicting CORE questions as a helpful tool. I understand it may be nearly impossible to include everything but at least core questions. Similar to DOT’s infectious 6.2 flow classification diagram. http://www.phmsa.dot.gov/pv_obj_cache/pv_obj_id_54AC1BCBF0DFBE298024C4C700569893C2582700/filename/Transporting_Infectious_Substances_brochure.pdf. And refer to readily available tools for more comprehensive risk assessment (example, BioRam, others)

  2. Anonymous's Gravatar Anonymous
    May 13, 2016    

    One thing we face at our facility is defining route of exposure for risk assessment. The most contentious item is whether an aerosol of a food-borne bacteria is an “aerosol” route of exposure, or an “oral” route of exposure because the aerosol would not normally enter the lungs and cause a problem (assuming relatively low dose, healthy adult human, etc. etc.), but if it lands in the mouth/oropharynx during breath and is ingested to the GI tract it can complete it natural exposure route and is more likely to cause a problem. Some researchers feel very strongly both ways, but my interpretation is that the route of exposure is based on the consequence, so an aerosol of a food-borne bacteria is an oral exposure and not an “aerosol” exposure. It makes a difference in the Sandia BioRAM tool in terms of the mathematical result (aerosol yes or no), so it’s a bit more than a theoretical distinction. Clarifying this issue would be helpful in a small but significant regard.

  3. Wm Bryan Burk's Gravatar Wm Bryan Burk
    May 12, 2016    

    The “Hazardous Characteristics of Laboratory Procedures” description may be clinging to a vestigial remnant with including mouth pipetting as a route of LAI. More descriptive would be the lack, misuse or failure of PPE and safe practices.

  4. Tim Baszler's Gravatar Tim Baszler
    May 12, 2016    

    The biological risk analysis section of the BMBL should be modernized and incorporate reference to animal and veterinary laboratories and facilities. A good reference would be The World Organization for Animal Health, “Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2015” chapter 1.1.3, “Biosafety and Biosecurity: standard for managing biological risk in the veterinary diagnostic laboratory and animal facilities”. The use of flowcharts to communicate the components of biohazard identification, biorisk assessment and biorisk communication are particularly effective.

  5. Anonymous's Gravatar Anonymous
    May 12, 2016    

    What is the ultimate goal of the risk assessment? Protect individuals from infection or release of agent from primary containment (vs. BSL-X lab) or both?

  6. Kalpana Rengarajan's Gravatar Kalpana Rengarajan
    May 12, 2016    

    The concept that agents have defined biosafety levels (BSLs) is problematic, especially for the clinical/diagnostic laboratory community. Linking agents to BSLs basically eliminates the concept of a rigorous, activity-specific or protocol-specific risk assessment. Why conduct a risk assessment if biosafety is defined as the implementation of a BSL, and the agent defines what BSL to use? The result is that substantive risk assessments are most often not conducted: “If I have H5N1, and I work in a BSL3, then I’m safe.”

  7. Kalpana Rengarajan's Gravatar Kalpana Rengarajan
    May 12, 2016    

    1. The risk assessment chapter needs to be rewritten. As it stands, it only articulates a hazard assessment – the identification of the various hazards in the laboratory. It also asserts that you should make a preliminary determination of the biosafety level following the agent hazard assessment, then a final biosafety level determination after considering procedure hazards. Then, you should evaluate staff proficiencies and the integrity of safety equipment. This makes no sense. A risk assessment should evaluate everything associated with a specific protocol before determining the appropriate mitigation measures.
    Most importantly, this chapter does not explain these fundamental aspects of a risk assessment:
    a. Articulate everything that could go wrong during a particular activity or protocol – the risks
    b. Prioritize the risks based on a rigorous, repeatable evaluation of the risks: Likelihood x Consequences
    c. Demonstrate how the chosen mitigation measures focus on reducing the highest priority risks
    d. Describe the metrics that will be used to routinely (or constantly) evaluate the effectiveness of the chosen mitigation measures

  8. Sandia National Laboratories International Biological and Chemical Threat Reduction's Gravatar Sandia National Laboratories International Biological and Chemical Threat Reduction
    May 12, 2016    

    Overall comments: It is strongly recommended that the risk assessment chapter be re-written. Fundamental concepts of risk must be clearly defined and the reliance on risk groups should be de-emphasized. It is recommended that the risk assessment process provide the readers with a better understanding of risk (what could go wrong), a prioritization of the evaluated risks, work procedures, human capability and limitations, and how implemented mitigation measures reduce the highest risk. A risk assessment should evaluate everything associated with a specific protocol before determining the appropriate mitigation measures. Preferably, risk assessment should look beyond the first step of hazard identification to determine risks associated with that hazard as a function of likelihood and consequences of an incident involving the hazard, and then assessing the acceptability of that risk and/or if the mitigation measures in place reduce risks to an acceptable level.

    Additional considerations:
    • Include a definition of biosecurity risk assessments and compare and contrast with biosafety risk assessments.
    • Include the need for multiple levels of personnel to be involved in the risk assessment process including management, the BSO, researchers, as well as engineers and maintenance staff.
    • Address how to conduct a risk assessment in low-resource settings using available existing mitigations, instead of relying on risk groups and BSLs.
    • Reference the risk assessment process in CWA 15793.

  9. ABSA Member's Gravatar ABSA Member
    May 11, 2016    

    I would like to see information in this section referring to recommendations for environmental monitoring of pathogens in high containment labs as part of an ongoing assessment of proper work practices and effectiveness of current risk assessments already in place.
    DOD investigation of Dugway Proving Grounds published on December 17, 2015 cited “failure to execute an environmental sampling program” as a failure of a risk mitigating step. Should all high containment labs be performing this?

  10. ABSA Member's Gravatar ABSA Member
    May 10, 2016    

    Comment: The information that is used in this section regarding the transmissibility of these CDC Select Agents in cagemates is very useful information to anyone engaged in the Risk Assessment process. In order to enhance accessibility of these facts to individuals engaged in the Risk Assessment process who are preparing to work with these agents, it is recommended to move these references of cagemate transmissibility to the appropriate any agent summaries for these infectious agents that are in Appendix D.

    Procedures that impart energy into a microbial suspension whether by hand or equipment create aerosols. The number of respirable size particles is outnumbered by the larger droplets that settle out on work surfaces and gloved hands. “The potential risk from exposure to droplet contamination requires as much attention in a risk assessment as the respirable component of aerosols.”

  11. ABSA Member's Gravatar ABSA Member
    May 10, 2016    

    Comment: In this section, there are multiple references made to “infective dose”. These references should be changed to “infectious dose” to be more consistent with terminology used within the BMBL and elsewhere.

  12. ABSA Member's Gravatar ABSA Member
    May 10, 2016    

    The concept of Risk Groups was introduced for the first time in BMBL in the 5th Edition, and a table of the World Health Organization (WHO 2004) and NIH (2002) definitions are given as defined by the (WHO). “They correlate with, but not do not equate to, biosafety levels. The risk assessment must still be done, to determine if the risk group will correlate with the biosafety level. (WHO) has recommended an agent risk group classification for laboratory use that describes four general risk groups based on the principal agent characteristics above and the route of transmission of the natural disease.”

    Comment: The WHO has recognized that the use of risk groups can be a systematic, effective way of considering multiple risks and hazards of infectious agents before engaging in their use. If they are to be noted within the BMBL, then it should be explicitly noted that the aerosol route of transmission must also be considered by anyone referencing the BMBL as part of the RA process. The WHO risk group process generally notes the need to consider route of transmission when assigning a risk group, but does not specifically reference aerosol route of transmission, which is a major consideration when establishing appropriate containment needed to handle infectious agents at BSL-3.

  13. ABSA Member's Gravatar ABSA Member
    May 10, 2016    

    It’s commendable to have moved this section to the front of the BMBL. Its movement recognizes the need to engage in the risk assessment process before one considers any other aspect of work with infectious agents.

    Comment: The section indicates that the results of the Risk Assessment should be used to alert staff to the hazards of working with the infectious agents and to the need for developing proficiency in the use of selected safe practices and containment equipment. It is suggested that you also consider specifically noting that work with toxigenic agents be included in this Risk Assessment process, since there is now a separate section on Biological Toxins in the 5th Edition of the BMBL. The risk assessment definition should be edited to note, that risk assessment is “the process used to identify the hazardous characteristics of a known infectious or potentially infectious agent or toxigenic material.”

  14. Association of Public Health Laboratories (Member Contributions)'s Gravatar Association of Public Health Laboratories (Member Contributions)
    May 10, 2016    

    The risk assessment chapter needs to be rewritten. As it stands, it only articulates a hazard assessment – the identification of the various hazards in the laboratory. It also asserts that you should make a preliminary determination of the biosafety level following the agent hazard assessment, then a final biosafety level determination after considering procedure hazards. Then, you should evaluate staff proficiencies and the integrity of safety equipment. This is incomplete. A risk assessment should evaluate everything associated with a specific protocol before determining a set of effective mitigation measures.
    Most importantly, this chapter omits these fundamental aspects of a risk assessment:
    a. Articulate everything that could go wrong during a particular activity or protocol – the risks
    b. Prioritize the risks based on a rigorous, repeatable evaluation of the risks: Likelihood x Consequences
    c. Demonstrate how the chosen mitigation measures focus on reducing the highest priority risks
    d. Describe the metrics that will be used to routinely (or constantly) evaluate the effectiveness of the chosen mitigation measures

  15. CSHEMA Biosafety Community of Practice's Gravatar CSHEMA Biosafety Community of Practice
    May 9, 2016    

    Page 12: There should there be a section on viral vectors, siRNA, rDNA constructs, etc.
    Page 12: Need to include the synthetic nucleic acid molecule definition.
    Page 13: The paragraph on types of approvals that are required under the NIH Guidelines should be removed. This is not very helpful to the reader since the BMBL does not specify what types of experiments require different levels of review. It is not necessary for the BMBL to duplicate this information presented in the NIH Guidelines this since text would easily become out of date.
    Page 19: Not all institutions use their IBC to conduct risk assessments on biosafety protocols that are not subject to the NIH Guidelines’ scope. This should be clarified.
    General Observations: No information on select agents (SA) is provided. Although the BMBL still applies to work with SAs, it should be mentioned that the USDA/APHIS and CDC have very specific criteria for working with particular select agents. These criteria must also be considered when doing a risk assessment. Dual Use Research of Concern (DURC) should also be considered during the risk assessment and included in this section.

  16. Jessica's Gravatar Jessica
    May 3, 2016    

    It is important to discuss risk assessments related to the use of recombinant/synthetic nucleic acids. There are too many people relying on assurances from suppliers on the “safety” of their viral vectors. It should be outlined in BMBL that “built in safety mechanisms” of viral vectors are not fail safe, not all vector suppliers do replication-competency testing, depending on the source, the vectors could have been contaminated at some point in the supply chain etc.

    It should also be mentioned that the base risk group of a viral vector system is not enough to determine the containment level. Factors like host genome integration, mechanism of transfection and nature of the transgene should be considered. In an HTML version of the BMBL, maybe links to libraries that enable people to look up information about the transgene should be available. Use of RNAi should be considered as depending on how it’s used, it could require the use of additional precautions.

    It would also be very valuable to discuss the various mechansims available for transfecting cells. Many of these mechanisms can transfect cells in vivo. Even if there’s a slim chance of replication, a big enough dose could impart a phenotypic change. Basic information such as this should be included in the BMBL.