Section IV – Laboratory BSL Criteria

Section IV:  Laboratory Biosafety Level Criteria (BSL1, BSL2, BSL3, BSL4)

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22 Comments

  1. Yolanda Arriaga Stringer's Gravatar Yolanda Arriaga Stringer
    May 20, 2016    

    Recommend discussing BSL2+ / BSL2-enhanced. While it has been stated that these are not recognized BSLs they are included in published risk assessments, factsheets, and guidance documents such as the NIH “Biosafety Considerations for Research with Lentiviral Vectors” and Pauwels 2009 “State-of-the-Art Lentiviral Vectors for Research Use: Risk Assessment and Biosafety Recommendations”. Recognizing, discussing, and providing a consistent recommendation for what these terms mean would provide support for safer practices when others oppose the increased cost and safety measures these BSL+ conditions entail.

  2. ABSA Member's Gravatar ABSA Member
    May 20, 2016    

    BSL-2

    Emphasis on sharps precautions has been removed from the introductory paragraph to BSL-2 and it is not mentioned at all in BSL-1. Accidents involving sharps that lead to laboratory acquired infections are still major health hazards in a microbiology lab. The emphasis on these types of precautions gained by their reference in this paragraph should not be removed in these opening statements.

    The need to place BSL-2 laboratories in non-public areas that was included in the 4th edition of the BMBL has been removed from the 5th Edition. Since the BMBL may be referenced by biosafety professionals who are new to biosecurity issues, it would be good to make the implicit explicit here and retain the requirement.

    Lab coats and eye protection should be required for all BSL-2 workers entering their BSL-2 laboratory. Splashes and spatters may occur when workers not working with the infectious agents are proximal to other workers who are performing this work. If lab coats and eye protection are worn by all of these workers, they are better protected against these incidental events, and they are better prepared to perform their own work with the infectious agent.

    Comment of A 5b: See comment for A5.b. for BSL-1.

    Comment on A.5.d: See comment for A.5.d. above for BSL-1.

    Comment on A.9: The new version requires signage if an infectious agent is “present,” i.e., even if it is in storage. Agents in storage do not present a risk at BSL-2. The verbiage of the 4th edition should be retained (requires posting biohazard information if/when the infectious agent is in use). Also, signage at the entry to a lab is the appropriate place where individuals will seek instruction for entering the lab, but not for exiting.

    Comment on B3: Medical surveillance may be appropriate for work with some BSL-2 infectious agents. (e.g. Hepatitis B Virus). Serum banking for all BLS-2 agents would not be universally warranted. Medical surveillance should be required as per the results of a risk assessment for the infectious agents in use and as appropriate in any infectious agent summary. Serum banking for specific at-risk personnel may be part of that medical surveillance effort, but it should not be a universal requirement for work at this level, since it may not be warranted.

    Comment on B10: It is good that recognition is being given to the generation of possible aerosols at this biosafety level and the need to contain them.

    Comment on C.3: Eye protection should be worn whenever an individual is in a lab, no matter what the activity being conducted, because splashes are not always predictable.

    Comment on C.4: This statement requires gloves be worn as protection from hazardous materials Instead, it should be based on a risk assessment and depend on activities to be conducted. If the term hazardous materials is meant to be inclusive of such things as hazardous chemicals, and radioactive materials, then such a recommendation is warranted. If this is case, then it should be explicitly stated. Furthermore, some of the agent summary statements are inconsistent with this statement by allowing discretion regarding the use of gloves (e.g., The Listeria statement says “gloves should be worn”). Also, alternatives to latex gloves should be available, as is noted in C4 of BSL-3.

    Comment on D11: This statement indicates, “A method for decontaminating all laboratory wastes should be available in the facility (e.g. autoclave, chemical disinfection, incineration, or other validated decontamination method).

    This is a new recommendation for facilities do work at BSL-2 over the 4th edition of the BMBL. The text indicates that all laboratory wastes would need to be treated on-site, and not just laboratory wastes generated from the testing of infectious agents and discarded cultures and stocks of infectious agents. There is an absence of references in the scientific literature indicating occupationally acquired infections from medical waste since the last edition of the BMBL that would support this new requirement. Many hospitals have clinical laboratories working at BSL-2 within them, and many of these institutions would not have the means of treating all laboratory waste in this manner since many hospitals have discontinued incineration and other medical waste treatment over time. These institutions use licensed medical waste contractors to have their medical wastes treated off site. In absence of a technical reason for this requirement, and in light of the excessive burden and expense it would place on patient care, this provision should be dropped for BSL-2 facilities.

  3. ABSA Member's Gravatar ABSA Member
    May 20, 2016    

    BSL-1 Labs

    Comment on A9: The statement in indicating, “A sign incorporating the universal biohazard symbol must be posted at the entrance to the laboratory when infectious agents are present.” In order to address this requirement when infectious agents are present, many doors of BSL-1 laboratories would likely be posted in the manner described on an on-going basis, and not just when the infectious agents are present. This practice would diminish the significance of this posting as a means of communicating potential biohazards anywhere in the facility, especially institutions which may also do work at higher biosafety levels in the same buildings. Regardless, for work with BSL-1 infectious agents, this posting provision should be removed for BSL-1 laboratories.

    Comment on C.3: Eye protection should be worn whenever an individual is in a lab, no matter what the activity being conducted, because splashes are not always predictable.

    Comment on A9: The statement in indicating, “A sign incorporating the universal biohazard symbol must be posted at the entrance to the laboratory when infectious agents are present.” In order to address this requirement when infectious agents are present, many doors of BSL-1 laboratories would likely be posted in the manner described on an on-going basis, and not just when the infectious agents are present. This practice would diminish the significance of this posting as a means of communicating potential biohazards anywhere in the facility, especially institutions which may also do work at higher biosafety levels in the same buildings. Regardless, for work with BSL-1 infectious agents, this posting provision should be removed for BSL-1 laboratories.

    Comment on C.3: Eye protection should be worn whenever an individual is in a lab, no matter what the activity being conducted, because splashes are not always predictable.

    Comment on C.4: Requiring gloves to be worn for protection from hazardous materials is inconsistent with the premise that agents causing human diseases are not handled under BSL-1 containment, if the hazardous materials referenced are the BSL-1 infectious agents. If the term hazardous materials is meant to be inclusive of such things as hazardous chemicals, and radioactive materials, then such a recommendation is warranted. If this is case, then it should be explicitly stated. Furthermore, this revision introduces an inconsistency with the NIH Guidelines. An apparent risk basis for this revision appears to be lacking.

  4. Shoolah Escott's Gravatar Shoolah Escott
    May 12, 2016    

    Page 6 item #5 uses the term BSL-2 agents and on page 12 #5 it says BSL-3 agents. There are no such things as BSL-2 or BSL-3 agents. They are agents that should be handled at the BSL-2 or BSL-3 level. It is important that the BMBL use the correct terminology since it is a reference. This incorrect terminology is unfortunately being used rather widely. It also adds to the confusion between biosafety levels and risk groups.

  5. Yolanda Arriaga Stringer's Gravatar Yolanda Arriaga Stringer
    May 12, 2016    

    Section IV.BSL2.D.9: More guidance on the negative pressure differentials to aim for in BSL2 labs is highly needed. Documented support is needed for institutions and engineers to prioritize and make achievable changes. Framing this guidance in language common to engineers would foster these changes considering that they often make changes per regulatory requirements rather than being convinced to do so by risk assessments.

  6. Pam Glass's Gravatar Pam Glass
    May 12, 2016    

    Request consideration for inclusion and description of the variety of BSL types of facilities. For example, consideration for BSL3 enhanced (BSL3e) facilities having extra measures which prevent any release of agent beyond a BSL3 lab that is off a main hallway in a university or company.

    In BSL3e facilities, where animal rooms are located within a suite of labs/ABSL3/offices with shower required for exit. Animal room could be considered primary containment. Requirement for conducting manipulations in a BSC or on downdraft table would not necessarily be required as it is for a BSL3 facility that is not a ‘change in and shower out’ facility and has only a requirement for Tyvek lab gown.

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

    The BMBL basically says: define the BSL, then you’re good to go. Biosafety achieved. What the bioscience community now needs – and what is currently missing from the BMBL – is an explanation that biosafety must be implemented within a management system. There must be a mechanism for creating metrics – in advance of the work, based on the risk assessment – that defines how the effectiveness of the safety mitigation measures will be evaluated on a routine basis. This is often called “performance management.” This concept is well engrained in medical diagnostic laboratories that must establish quality management systems – as well as in other high-consequence industries. Surprisingly, we do not promote an analogous (or integrated) safety management system in the biosciences. We have no mechanisms to routinely collect information about what works and doesn’t work, and to document unexpected events in the lab, near misses, accidents, etc. This data, which should be collected on a routine (daily?) basis, should be used to constantly update the risk assessment, and to modify/improve mitigation measures before an accident happens. This is absolutely key for the future of biosafety. The BMBL must articulate a management system concept to move biosafety out of the administrative basements of bioscience laboratories – and the perception that biosafety is only the responsibility of the designated “biosafety officer” – and to create a system that invests the entire scientific staff in the performance of the safety system.

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

    The BMBL was written for research labs that (generally) know what agent they work with. Diagnostic labs generally do not know the agent; the purpose of their work is to identify the agent or cause of the disease or malady. The BMBL really provides little biosafety guidance for laboratories that must diagnose unknowns. Should there be a new/separate document for diagnostic/clinical labs? Hospitals and clinical labs in the US refused to test suspect Ebola samples because of the BMBL. Imagine what would happen with a more ubiquitous infectious disease, like Zika might be. Zika suspect samples might be Chik, and the BMBL defines Chik as BSL3. How many clinical labs have BSL3? Hardly any. It would be a disaster if we experienced a widespread outbreak in the United States.

  9. 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: The concept that agents have defined biosafety levels (BSLs) is challenging and eliminates the need for risk assessment based-thinking. A biosafety level as defined concerns a specific set of mitigation measures implemented. An agent (hazard) should be characterized strictly by the risk it poses (potential to cause an infection via various routes and the severity of the infection –i.e. likelihood and consequences). The hazard should be evaluated in terms of the activities to further define the risk that will derive the type of laboratory biosafety required. Moreover, not all laboratory activities warrant the same mitigation measures even with the same pathogens.

    Additional considerations:
    • Discuss how field research/sampling (especially in low-resource settings) can operate safely without specific BSL functionality.
    • Mention the importance of using PPE and laboratory equipment according to manufacturer’s guidance.
    • Regarding air-ventilation on Page 43 Bullet 9. The sentence regarding failure and positive pressure peak is almost unachievable and has subsequently ramped up prices to achieve this goal. Some electronic monitoring systems will collect data on a continuous basis and will peak positive during some procedures (e.g. if a door is slammed hard or if a bucket of hot water is dumped on the floor).

  10. Sonia Godoy-Tundidor, PhD's Gravatar Sonia Godoy-Tundidor, PhD
    May 11, 2016    

    * General comment: Some of the requirements for different BSL or ABSL are the same, but the sentences are constructed differently. Please try to use the same language whenever possible.

    * Page 31 – A. Standard Microbiological Practices, Point 8: “Depending on where the decontamination will be performed, the following methods should be used prior to transport”. Please remove “prior to transport”, since 8b. refers to “Materials to be removed from the facility for decontamination”. The same issue should be corrected on pages 34 (BSL-2 labs) and 39 (BSL-3 labs).

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

    For BSL-3:

    Comment on B.3: See Comment B3 above for BLS-2. Any serum banking should be rolled into the medical surveillance requirements for BSL-3 agents as determined by the risk assessment or detailed by the specific agent summary in the BMBL.

    Comment on B.7a: A statement should precede this section stating, “BSL-3 facilities must develop plans for dealing with spills of infectious materials.” Knowledge of the number of room air changes per hour would be needed as part of this effort so that a determination can be made when it is safe for properly prepared personnel to re-enter the room to clean up the spilled material. Another statement should be added indicating, “BSL-3 facility staff need to be made aware of the plan and how to initiate its provisions in the event of spills of infectious materials.”

    Comment on C.3: Eye protection should be worn whenever an individual is in a BSL-3 laboratory, no matter what the activity being conducted, because splashes are not always predictable.

    Comment on C.5: The determination about wearing a face shield and/or respirator should be based on the risk assessment, not an absolute requirement as written. There are circumstances where it is not necessary to wear a face shield.

    Comment on D.12: The statement should read, “These HEPA filters should be tested at least annually and replaced as indicated by the trends in the HEPA filter testing.” HEPA filters in some biocontainment devices such as biological safety cabinets will last for years. Their removal yearly may secondarily loosen some connections within the biosafety needed to ensure containment. If the HEPA filter testing is done and is monitored for decreasing performance, then these filters can be changed in advance of failure without sacrificing the other containment benefits. HEPA filters in biocontainment devices that cannot be accessed for annual testing in this manner should be changed annually.

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

    Emphasis on sharps precautions has been removed from the introductory paragraph to BSL-2 and it is not mentioned at all in BSL-1. Accidents involving sharps that lead to laboratory acquired infections are still major health hazards in a microbiology lab. The emphasis on these types of precautions gained by their reference in this paragraph should not be removed in these opening statements.

    The need to place BSL-2 laboratories in non-public areas that was included in the 4th edition of the BMBL has been removed from the 5th Edition of the BMBL. Since the BMBL may be referenced by biosafety professionals who are new to biosecurity issues, it would be good to make the implicit explicit here and retain the requirement.

    Lab coats and eye protection should be required for all BSL-2 workers entering their BSL-2 laboratory. Splashes and spatters may occur when workers not working with the infectious agents are proximal to other workers who are performing this work. If lab coats and eye protection are worn by all of these workers, they are better protected against these incidental events, and they are better prepared to perform their own work with the infectious agent.

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

    Comment of A 5b: This statement should read,” Used disposable needles and syringes must be carefully placed in conveniently located puncture-resistant and leak resistant containers for sharps disposal.
    Comment on A.5.d: The recommendation that plasticware be eliminated at BSL-1 seems excessively precautious. Furthermore, this revision introduces an inconsistency with the NIH Guidelines, as noted in A1, and A3. In the absence of evidence by the harm posed by glassware at BSL-1, the wording of the 4th edition should be retained for these provisions.

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

    General Comments regarding Section IV and Section V: Increased stringency has been introduced into BSL-1 and BSL-2 procedures. Justification to support increasing the level of precautions for many of the practices has not been demonstrated in all cases; implementation of these changes may impose a significant burden on a number of institutions. This is especially true for work at BSL-1 infectious agents. These agents are well characterized which are not known to cause disease in healthy individuals. Further, there typically are a number of medical treatments available for individuals with personal risk factors that may experience a rare infection as a consequence of exposure to these agents.

    Posted signage should provide the critical information; anything else posted that detracts from that critical information can result in all warnings and cautions being ignored. Any information that is not critical at the moment of entry into the area, such as general occupational health requirements, should be included as part of the required biosafety manual.

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

    Page 31: Sometimes there are situations where recapping needles using engineering controls or one-handed technique is safer than not recapping (i.e., loading syringes for an animal study). The 6th edition should indicate that there are safe methods for recapping instead of prohibiting it.
    Page 31: The 6th edition should further explore why a biohazard symbol should be posted for BSL-1 when no infectious agents are present.
    Page 35: This section should specify some specific items that should be included in the lab specific biosafety manual.
    Page 36: This section essentially states that eye protection is not required if using a biosafety cabinet. This should be revised to say that eye protection to be used if determined by risk assessment.
    Page 59: The summary table is not consistent with the sub-parts for each biosafety level.
    General Observations: Should there be information on the types of administrative institutional oversight that should be provided for specific biosafety levels (i.e., who should be conducting a formal risk assessment)? Also, why do the authors bring up specific PPE requirements for animal work in these sections?

  16. Heather Blair's Gravatar Heather Blair
    May 4, 2016    

    BSL2 D. Laboratory Facilities currently reads: “Laboratories must have a sink for handwashing. The sink may be manually, hands-free, or automatically operated. It should be located near the exit door.” I recommend removing “manually” and state the sink needs to be hands-free or automatically operated for BSL2 labs. It is stated in the Introduction that, “BSL2 is appropriate for handling moderate-risk agents that cause human disease of varying severity by ingestion or through percutaneous or mucous membrane exposure.” The Principles of Biosafety Section states that the recommended secondary barriers depend on the risk of transmission of specific agents and the transmission of specific agents worked with in BSL2 labs include ingestion and mucous membrane exposure. Typically in the BSL2 individuals are wearing one pair of gloves and the reason for washing hands before leaving the lab is to remove potential exposure from the hands. With a manual sink, individuals touch a handle to turn the sink on (with unwashed hands), wash their hands, and then touch the same handle to turn the water off. This would be dispelled by requiring hands free or automatic sinks in BSL2 labs.

  17. Scott Patlovich's Gravatar Scott Patlovich
    May 3, 2016    

    Correction required from current version (5th edition) of BMBL: Section IV, Page 58, Item #13 (under Suit Laboratory subheading) – The first sentence of this item reads “A double-door, pass through autoclave(s) must be provided for decontaminating materials passing out of the cabinet laboratory.” This appears to be a copy and paste error from the previous cabinet laboratory subheading and should be updated to read “…passing out of the suit laboratory.”

  18. Dan Frasier's Gravatar Dan Frasier
    May 2, 2016    

    BSL-3, section D, item 14 (p. 44)
    Consider adding a statement about gas tight dampers used to facilitate laboratory isolation recommending that they be located as close as possible to the containment space, without restricting access.
    Justification: To limit the amount of high containment duct included within the containment zone.

  19. Dan Frasier's Gravatar Dan Frasier
    May 2, 2016    

    BSL-3, D9 (p. 43)
    Consider adding a description of what constitutes a “failure condition”. Examples should include both loss and restoration of the following: Supply air fans, exhaust fans and emergency / standby power.
    Note: The CDC DSAT policy provides similar recommendations.

  20. Dan Frasier's Gravatar Dan Frasier
    May 2, 2016    

    BSL-3, A11 (p. 40) Consider adding to item A11 or perhaps adding as item A12.
    BSL-4, A10 (p. 46) Consider adding to item A10 or perhaps adding as item A11.
    The laboratory supervisors must ensure that laboratory personnel receive appropriate training regarding the operation and limitations of the systems used to control and monitor biocontainment and laboratory environmental conditions. Any personnel with secure access to the laboratory must receive a level of training commensurate with that individual’s roles and responsibilities. Facility training includes topics such as biosafety alarms and notifications, overview of the laboratory HVAC system and tutorials on the building automation system.

  21. J. Paul Jennette, MS, PE, RBP's Gravatar J. Paul Jennette, MS, PE, RBP
    April 15, 2016    

    Please incorporate the approach to directional airflow reversals and performance verification for BSL-3 facilities used in the CDC DSAT policy statement on BSL-3/ABSL-3 Verification dated November 20, 2014 (http://www.selectagents.gov/regBSL3ABSL3policy.html). Specifically, statements in the BMBL 5th edition such as “The laboratory shall be designed such that under failure conditions the airflow will not be reversed.” (Pages 56 and 66) should be changed to adopt the following language from the DSAT policy: “A facility may be considered to pass the HVAC verification tests as long as laboratory air does not exit the containment barrier of the facility. The BSL-3 anteroom is considered to be within the containment envelope. A positive pressure excursion is not necessarily an airflow reversal; if a brief, weak positive pressure excursion is noted, a repeat test may be performed with airflow observation using an airflow indicator such as a smoke stick, or dry ice in a container of water, at the base of the closed laboratory door to confirm whether airflow reversal is occurring.”

  22. Geoff Ferman's Gravatar Geoff Ferman
    April 11, 2016    

    BSL-3; Section C; Item 3: Clarify interpretation of last sentence. Currently reads: “Persons who wear contact lenses in laboratories must also wear eye protection.”
    One interpretation could be that the use of contact lenses does not provide any additional protection for the eye. Therefore, when there is an anticipated splash or spray of infectious or other hazardous material, use of PPE is warranted and it must also be used when an individual wears contact lenses. Another interpretation could be that regardless of risk assessment regarding an anticipated splash or spray of infectious or other hazardous material, if an individual wears contact lenses within the BSL-3 they must use eye protection.