Section III – Principles of Biosafety

Section III:  Principles of Biosafety (Laboratory practices and technique, safety equipment (primary barriers and personal protective equipment), facility design and construction (secondary barriers), biosafety levels, animal facilities, clinical laboratories, importation and interstate shipment of certain biomedical materials, select agents)

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6 Comments

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

    Page 27 referencing clinical laboratories handling of specimens in a BSL-2 laboratory and only suggests using a BSC if there is an indication to do so. I disagree. According to the MMWR, Supplement vol. 61 January 6, 2012 which states on page 13 section 3.1:

    “Ideally, all specimens in a biosafety level (BSL) 2 or higher facility are to be processed in a biological safety cabinet (BSC) adhering to safe BSC practices.” Then they should decide if BSL-2 or BSL-3 practices are appropriate based on their risk assessments.

    This is what we are telling our clinical labs to do.

  2. 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 current focus of this section is on mitigation. It is recommended to reinforce a risk-based approach to inform appropriate selection of mitigation measures and performance verification that mitigation measures are reducing risk. Moreover, it is recommended to emphasize the need for routine monitoring and assessment of laboratory biosafety performance.

    Additional considerations:
    • Consider laboratory biosafety needs for other types of research laboratories – clinical and diagnostic laboratories, low resource settings, laboratories handling plants, aquatics etc.

  3. wing wong's Gravatar wing wong
    May 10, 2016    

    On page 25, it says “BSL-2 is appropriate when work is done with any human-derived blood, body fluids, tissues, …may be unknown”.

    Will the BMBL make a more definitive statement than using the word “appropriate”? “Appropriate” is more align with a recommendation instead of a requirement. Is this still the BMBL’s stance?

    Furthermore, what about human sourced proteins such as hemoglobin and fibrinogen? Can the BMBL provide their guidance in the new edition of the BMBL when it comes to the BSL of human sourced proteins?

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

    Page 28: Should also include IATA for transport by air and FAA.
    This section should also include an introduction to field work biosafety (handling agents outside of the lab environment), plant biosafety, and arthropod biosafety.
    The Select Agent and Transportation/Interstate Transfer Sections seem out of place the way they are presented in this section of the BMBL. We suggest to change this part of the Section to “Movement/Transfer of Biomedical/Infectious Material.”

  5. Gonzalo Pascual Alvarez's Gravatar Gonzalo Pascual Alvarez
    April 30, 2016    

    I think that will be interesting include in this section the concept of Tertiary Barriers.
    Tertiary barriers deal with the physical operation with items such a walls, fences, security, quarantine and animal exclusion zones. Due to the varying risk of biological agents, the facilities that handle these agents need to be designed and classified accordingly.
    BSL facility design and operational procedures must be documented. Thefacility must be tested for verification that the design and operational parameters have been mer prior to operation; facilities must be reverified annually.
    The contaiment laboratories have to be located away from external building envelope walls; furthermore they must be separated from other areas in the ssame building or be situated in a separate building.
    Acces to the facility as to be limited by means of secure, locked doors to persons, whose presence in the facility is requiered for program or support purposes; accessibillity is managed by the laboratory director, biohazard control officer, or person responsible for the physical security of the facility.
    A biohazard signs on the door must identify the agent and list the name of the responsible persons.

  6. Brian O'Shea's Gravatar Brian O'Shea
    April 29, 2016    

    Section III details the most important aspects of biological safety which is using proper microbiological practices and techniques. Unfortunately this section is lacking in what good microbiological practices and techniques are and how persons should be “trained and proficient” in such practices. This section should detail certain common practices that all microbiologists should be proficient in and also descriptions of common proper procedures. Most of this section describes facility design and construction and often researchers rely to heavily on facility and primary containment aspects for safety rather than good microbiological technique.