Appendix D – Agriculture Pathogen Biosafety

Appendix D: Agriculture Pathogen Biosafety

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  1. Christina M. Loiacono's Gravatar Christina M. Loiacono
    May 13, 2016    

    The USDA-National Animal Health Laboratory Network (NAHLN) requests inclusion in the revised BMBL (6th Edition) language regarding enhanced BSL-2 guidelines when conducting testing for high consequence agricultural pathogens (HCP) in veterinary diagnostic laboratories. NAHLN is a partnership of state and federal veterinary diagnostic laboratories that provide investigational and surveillance testing for HCP, as well as testing of high sample loads in response to emergency disease outbreaks. Biorisk management for HCP principally focuses on prevention of environmental contamination from laboratories but also includes biorisk associated with zoonotic potential for some HCP agents.
    It is routine for accredited veterinary diagnostic laboratories to follow standard BSL-2 safety guidelines when testing diagnostic unknowns. Guidelines include procedures as well as primary barriers and secondary barriers. Testing of HCP under full BSL-3 guidelines (procedures, primary barriers and secondary barriers) is ideal, but testing under enhanced BSL-2 guidelines is appropriate for some types of sample flow and testing procedures, such as molecular diagnostics testing of suspect HCP in routine surveillance or high-throughput outbreak situations. Implementation of full BSL3 guidelines in these types of scenarios creates undue burden and must be weighed against the need for rapid, efficient, accurate disease response, control and recovery.
    Thus, there is a need to formalize definition of fundamental enhanced BSL-2 guidelines for HCP with the realization that full definition of enhanced BSL-2 at the individual laboratory level will also require implementation of biological risk analysis. At the individual laboratory level and according to the biological risk analysis detailed controls (administrative, operational, engineering) and personal protective equipment required for specific types of samples, sample flow, and testing procedures (e.g. molecular testing (PCR), necropsy, virus isolation, serology) would be determined.
    To address this need for general guidelines that allow efficient and rapid yet safe testing, the following BSL-2 enhanced procedures are suggested for inclusion in BMBL- 6th edition.
    • Controlled access
    • Decontamination of all waste
    • Decontamination of laboratory clothing before laundering
    Primary barriers and safety equipment:
    • Biosafety cabinets or other physical containment devised used for manipulation of agents as determined by laboratory biological risk analysis
    • PPE: Protective laboratory clothing, gloves, eye and respiratory protective as determined by laboratory biological risk analysis

  2. Julie Johnson's Gravatar Julie Johnson
    May 11, 2016    

    In general Sections I, II and III of this Appendix D seem to be a mix of general discussion and description of possible facility features and practices mixed with some very specific facility requirements. The inconsitency is very confusing. Section II.1., II.3., II.6., and III.1. need complete rewriting to be consistent and understandable to users.

    Additionally, these sections only address BSL-3Ag and BSL-3 enhanced work with agricultural pathogens, and don’t adequately separate out the issues of agricultural animals and agricultural pathogens. Agricultural animals may be used for research with human pathogens. Strict agricultural pathogens may be used for research in small laboratory animals or just in a lab. What about strict agricultural pathogens that don’t require BSL-3E or BSL-3Ag containment but need some kind of containment? 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 agricultural pathogens that require containment similar to BSL-1 or BSL-2 (consider defining BSL-1Ag, BSL-2Ag, BSL-3Ag, BSL-4Ag for animal pathogens, and similar containment levels for plant pathogens).
    – use of human pathogens in loose housed animals – maybe best addressed in Section V?
    – use of agricultural animal pathogens that would be classified as RG1 but which might necessitate higher level containment; this guidance should address work in labs, small lab animals, and larger loose housed animals – best adddressed in Appendix D?
    – use of plant pathogens that would be classified as RG1 but which might necessitate higher level containment – best addressed in a new appendix?

    In lieu of additional BMBL sections, all discussion of agricultural pathogens that don’t affect humans should maybe be removed form the BMBL and covered in the proposed USDA Agriculture equivalent of the BMBL.