Section V – Vertebrate Animal BSL Criteria

Section V:  Vertebrate Animal Biosafety Level Criteria for Vivarium Research Facilities (ABSL1, ABSL2, ABSL3, ABSL4)

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10 Comments

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

    ABSL-3

    Comment on A1: Review by IBCs should be limited to specific activities involving infectious, toxigenic agents, allergenic agents and recombinant agents. (i.e. activities that may pose a health issue to the lab worker or environmental issue.)

    Comment on A2: The statement should read, “The safety manual should be prepared and (not or) adopted.”

    Comment on A5: The signage requirement fails to address the complexity of some animal facilities, which are likely to have rooms at ABSL-1, -2, and -3. Specific information should be posted on the door to each animal room, not at the entrance to the animal area. Advance consideration of emergency and disaster recover plans does not fit the context of signage requirements; this information belongs in the facility operations manual.

    Comment on C3: Section II of the BMBL indicates that a risk assessment should be undertaken before beginning to work with infectious agents. Use of respiratory protection should be based on the risk assessment.

    Comment on C4: The statement regarding use of gloves for ABSL-3 allows more discretion than parallel statements for lower risk situations

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

    ABSL-2

    Comment on A1: Requiring IBC review of all animal protocols is beyond the scope of an IBC. The animal protocol is a specific document that focuses on animal welfare and is the purview of the IACUC. Review by IBCs should be limited to specific activities involving infectious, toxigenic agents, allergenic agents and recombinant agents. (i.e. activities that may pose a health issue to the lab worker or environmental issue.)

    Comment on A2: This statement should read, “the safety manual should be prepared and (not “or”) adopted.”

    Comment on A15: The statement should read “Decontaminate of all…”

    Comment on B3: The recommendation to autoclave waste prior to incineration is excessive for ABSL-2. Proper waste treatment by either of these two methods should be acceptable.

    Comment onD1: There is a typographical error: “Doors…animals are housed or open inward…”

    Comment on D3: As stated, sealing penetrations is now required for all ABSL-2 facilities. This revision introduces a significant burden for institutions to implement. In the absence of evidence of harm from non-sealed facilities, this statement should be revised to be a recommendation, not a requirement.

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

    ABSL-1

    General comments: Biohazard signage is not required for these agents, but it is earlier required for BSL-1 agents. In the standard practices section, the use of lab coats by workers is required at this animal biosafety level, but in the special practices section, use of lab coats is recommended. Also, the provisions regarding glove use in A7, standard practices, and in B4, special practices, are essentially identical. The glove provisions in the special practices section should be deleted.

    Comment on A1: Requiring IBC review of all animal protocols is beyond the scope of an IBC. The animal protocol is a specific document that focuses on animal welfare and is the purview of the IACUC. Review by IBCs should be limited to specific activities involving infectious, toxigenic agents, allergenic agents and recombinant agents. (i.e. activities that may pose a health issue to the lab worker or environmental issue.)

    Comment on A5: Signage needs to be minimal and to the point. To post all the information required by this section on a sign at the animal facility entrance results in a posting where the critical information will be ignored. As written (“and/or”), a sign must be posted everywhere animals are housed, without consideration of the presence of infectious agents, yet incorporating the biosafety level. There should be no biohazardous risk to humans at ABSL-1 and therefore no sign regarding the biosafety level. A different sign would be appropriate if containment is used for an animal pathogen or chemical hazard, and such posting should be associated with the specific room, not the entrance to the animal facility. Posting “general occupational health requirements” on a sign at the entrance to an animal area is not relevant for entry. General information belongs in the facility manual. Specific and unique occupation health requirements should be associated with specific animal housing rooms.

    Comment on A7: The requirement to wear protective clothing is contradicted in C.2 (“recommended”). As written, gloves must always be worn when handling animals. This requirement is hard to justify based on biohazard at ABSL-1. Discretion should be allowed to use gloves as deemed necessary by the risk assessment. The similar statement for ABSL-1 under C.4 allows discretion (“should”) with regard to wearing gloves. The equivalent statement for ABSL-3 uses “should”, allowing discretion.

    Comment on D.1: There appears to be a typographical error in the statement, “Doors …animals are housed or open inward…” This same error appears in other sections.

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

    * Page 79 – The description of different types of animal caging systems is a little bit confusing (for example: “containment caging systems, such as solid wall and bottom cages covered with filter bonnets, open cages placed in inward flow ventilated enclosures, HEPA-filter isolators and caging systems”). Can these descriptions be modified (example: ventilated cage racks, etc.) and pictures added to the BMBL?

    * Page 81, Point 2: “Disposable personal protective equipment […] decontaminated prior to disposal” – Does it have to be decontaminated always, or can it be discarded in a biological waste box prior to transport and incineration?

    * Page 88, Point 8: Please delete the initial sentence “Supplies and materials needed in the facility must be brought in through a double-door autoclave, fumigation chamber, or airlock”, since it is repeated in the sentence below.

    * Page 93, Suit Laboratory, Point 1: is it correct to use “open cages placed in ventilated enclosures” in this type of lab?

    * Table 3, Page 103: Substitute “ABSL” for “BSL”. In ABSL-2, change “animal special” for “animal species”. “Disinfectant foot bath as needed” is only mentioned on this table for ABSL-3 labs, but nowhere else in the BMBL. In ABSL-4, change “which post high risk” to “which pose high risk”.

  5. Julie Johnson's Gravatar Julie Johnson
    May 10, 2016    

    This section really only addresses work with small laboratory animals that cna be housed in contained cages. I suggest adding additional sections that address the use of larger research animals that cannot be housed in contained cages but must be loose housed, such as pigs, sheep, cattle. There is lots of research ongoing that involves RG2 organisms. This work doesn’t necessarily fall under the guidance in Appendix D (agricultural pathogen biosafety), which primarily addresses BSL-3Ag requirements. We also need to be cautious about lumping together agricultural animals with agricultural pathogens. Agricultural animals may be used for research with human pathogens. Agricultural pathogens (such as strict animal pathogens) may be used for research in small laboratory animals. Currently IBCs and biosafety officers must rely on individual risk assessment to determine truly appropriate practices.
    It would be very useful to have sections that provide guidance for:
    – use of human pathogens in loose housed animals
    – use of agricultural animal pathogens that would be classified as RG1 but which might necessitate higher level containment; this guidance shodul address work in labs, small lab animals, and larger loose housed animals.
    – use of plant pathogens that would be classified as RG1 but which might necessitate higher level containment.

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

    Page 61 (A1), 67 (A1), 76 (A1): Reference to IACUC and IBC approving work at ABSL 1, 2, 3. Do all Institutes convene IBC for animal work approvals?
    Page 86 (A1): Related to bullet above – ABSL-4 reference cites IACUC and Biosafety Official, IBC or other applicable committees are responsible for review of hazards, etc.
    This wording might replace the note above referencing IBC for ABSL 1, 2 and 3.
    Page 87: Reads weird. “ Use of needles and syringes or other sharp instruments are limited for use in the animal facility (*and) is limited to situations where there is no alternative…” Reword sentence or add an “*and”. Likely a typo but could be especially confusing for ESL person.
    Page 89 (A, 11) and 90 (B, 1): State the exact same information – “Personal health status may impact an individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions. Therefore, all laboratory personnel and particularly women of childbearing age should be provided with information regarding immune competence and conditions that may predispose them to infection. Individuals having these conditions should be encouraged to self-identify to the institution’s healthcare provider for appropriate counseling and guidance.” A bit redundant but perhaps done due to the importance of the message?

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

    Correction required from current version (5th edition) of BMBL: Section V, Page 101, 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.”

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

    Same comment was submitted for Section IV
    ABSL-3, D6 (83-84)
    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.

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

    Similar comment was submitted for Section IV
    ABSL-3, A3 (p.76) Consider adding to item A3 or perhaps adding as a separate item.
    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, tutorials on the building automation system and ventilated caging system isolation/decoupling from building exhaust.

  10. Jessica McCormick-Ell's Gravatar Jessica McCormick-Ell
    April 19, 2016    

    The requirements for on-site decontamination for ABSL2 is vague and we would like to see something more specific. Some argue that packaging for incineration is sufficient, but others argue autoclaving is key. A more specific statement for waste treatment/ disinfection prior to disposal would be very helpful. If there are alternatives to autoclaving, that would be warranted as well. Additionally, a requirement for autoclave validation should be included.