Biosafety Manual PDF - Lawrence Berkeley National Laboratory

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Biosafety Manual IBC-approved version (May 18, 2010) • Bloodborne pathogen (BBP) materials (e.g., human blood, human tissues, or human cells); • nonhuman primate tissues or cells; • viral vectors that are replication defective but still infectious to human cells; • laboratory animals (e.g., rodents) infected with, implanted with, or containing RG2 agents or materials (e.g., infected with a human pathogen or containing a xenotransplant of human cells); and • tissues or cells potentially containing an RG2 agent (e.g., cells transformed with a RG2 virus). 4.4.2 Additional Containment Categories Additional types of containment specified in the NIH Guidelines or BMBL may also be applicable to work with biological materials at LBNL. Table 9 below lists these additional containment categories and relevant NIH Guidelines or BMBL section. When selecting a containment level for a type of work listed in Table 9, the supervisor, work lead, and IBC should carefully review this table to determine if the containment category and criteria apply to the planned LBNL work. Laboratory- or operation-specific authorizations, biosafety manuals, or other documents may be used to document the containment requirements related to the work. If the containment categories or criteria presented in Table 9 are not applicable to the work, the laboratory BLs presented in Section 4.4.1 of this manual are applied. 4.4.2.1 Recombinant Large-Scale Containment Levels Physical containment guidelines from Appendix K of the NIH Guidelines must be used for largescale research or production activities involving viable organisms containing recombinant DNA molecules. Large scale (BL–Large Scale) is a term used in the NIH Guidelines and the LBNL biosafety policy to describe uses of and containment levels for organisms containing recombinant DNA molecules involving a quantity of culture greater than 10 liters. Note that this quantity category typically means the quantity of a material in a single batch of liquid culture; however, this batch quantity is not defined by NIH and should be used as a guideline to determine the applicability of large-scale containment criteria. Criteria for large-scale containment address the biological hazard associated with organisms containing recombinant DNA only. Large-scale containment criteria must be selected based on the findings of the risk assessment, and then documented in the Biosafety Work Authorization. 4.4.2.2 Recombinant Plant Containment Levels Biosafety containment levels and criteria for recombinant research with plants must be selected based on the findings of the risk assessment, and then documented in the Biosafety Work Authorization. Laboratory or plant biosafety containment levels must be applied to the work as follows: • Laboratory BLs and criteria discussed in Section 4.4.1 of this manual and Appendix G of the NIH Guidelines should be used when the research plants are of a size, number, or have growth requirements that allow good containment when using laboratory BLs. • Plant BLs (BL-P) must be used when the research plants are of a size, number, or have growth requirements that preclude the use of laboratory BLs. For plant BLs and criteria, see Appendix P (Physical and Biological Containment for Recombinant DNA Research Involving Plants) of the NIH Guidelines. Printed copies are not official versions of this manual. Before using the printed copy, verify that it is the most current version. 36
Biosafety Manual IBC-approved version (May 18, 2010) Table 9 Additional Containment Categories Containment Category large-scale uses of organisms containing recombinant DNA molecules recombinant DNA research involving plants recombinant DNA research involving animals vertebrate animal BL criteria for indoor research facilities (e.g., vivariums) arthropod containment guidelines Standard and Section NIH Guidelines, Appendix K NIH Guidelines, Appendix P NIH Guidelines, Appendix Q BMBL, Section V BMBL, Appendix E Focused Scope of Containment Criteria Physical containment guidelines for large-scale (greater than 10 liters of culture) research or production activities involving viable organisms containing recombinant DNA molecules Physical and biological containment conditions and practices suitable to greenhouse operations that conduct experiments involving plants, plant-associated microorganisms, and small animals (e.g., arthropods or nematodes) Containment and confinement practices for research involving whole animals when the animals are of a size or have growth requirements that preclude the use of containment for laboratory animals (i.e., including but not limited to nonhuman primates, cattle, swine, sheep, goats, horses, and poultry) and: • The animals’ genomes have been altered by the introduction of recombinant DNA or DNA derived therefrom into the germ line (transgenic animals), or • Experiments involving viable recombinant DNAmodified microorganisms have been tested on whole animals. Use of experimentally infected animals housed in indoor research facilities (e.g., vivariums), and the maintenance of laboratory animals that may naturally harbor zoonotic infectious agents Risk assessment and containment for arthropods of public health importance including those that transmit pathogens. Arthropods that only bite, sting, or cause myiasis and infestation are not included. Myiasis is an infestation of tissue by fly larvae, or a disease resulting from such infestation. The plant BLs listed in Appendix P of the NIH Guidelines specify physical and biological containment conditions and practices suitable for conducting greenhouse experiments involving recombinant DNA-containing plants, plant-associated microorganisms, and small animals. Acronyms for plant BLs are BL1-P through BL4-P. The following bullets further clarify terms and applicability of the plant biosafety levels: Printed copies are not official versions of this manual. Before using the printed copy, verify that it is the most current version. 37
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