Biosafety Manual PDF - Lawrence Berkeley National Laboratory

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Biosafety Manual IBC-approved version (May 18, 2010) pathogens or infectious agents. Listed and linked below are biosafety standards that cover human pathogens. • Human Etiologic Agents (NIH Guidelines) The NIH Guidelines provide a list of human pathogens and their RG2, RG3, and RG4 designations in Appendix B (Classification of Human Etiologic Agents on the Basis of Hazard) of the NIH Guidelines (also see Appendix B of this manual). Work with human pathogens at LBNL will be conducted in accordance with the agent-specific RG designations in Appendix B of the NIH Guidelines and this manual. • BMBL Human Pathogens BMBL agent summary statements contain BL-specific containment guidance for specific human pathogens (see Section 3.3.2.1). Work with human pathogens at LBNL will be conducted in accordance with the IBC. The IBC will determine the proper containment level for pathogenic work, and use the recommended BL guidance presented in BMBL agent summary statements when available and applicable to the work activity. See Section 4.4 of this manual for additional information on BLs. • DOE WSHP Biological Etiologic Agents The DOE WSHP regulation (10 CFR 851, Appendix A, Section 7) has specific requirements for “biological etiologic agents.” LBNL’s program to comply with 10 CFR 851 defines a biological etiologic agent as an agent of biological origin (e.g., bacterium, fungus, parasite, virus, etc.) that causes disease in humans (i.e., pathogenic to humans). See Appendix B of this manual for the NIH list of human etiologic agents. See PUB-3000, Chapter 26, Appendix D, for specific LBNL requirements related to biological etiologic agents under 10 CFR 851. • OSHA Bloodborne Pathogens See Section 3.3.3 and Appendix C of this manual for requirements related to human pathogens that are considered bloodborne pathogens (BBPs) under the OSHA Bloodborne Pathogens Standard. • CDC Select Agents The Health and Human Services (HHS) CDC regulation on select agents and toxins lists agents that are both select agents and human pathogens. See Section 3.3.2.5 of this manual for more information. 3.3.2.3 Plant and Animal Pathogens See Section 3.3.3 (USDA-Regulated Materials, Organisms, and Agents) for information on plant and animal pathogens and Section 3.3.2.5 for more information on plant and animal pathogens that are also select agents. 3.3.2.4 Biological Toxins Biological toxin, biotoxin, or toxin is a poisonous substance produced by a living organism. The poisonous nature of toxins means that they may cause death or severe incapacitation at Printed copies are not official versions of this manual. Before using the printed copy, verify that it is the most current version. 18
Biosafety Manual IBC-approved version (May 18, 2010) relatively low exposure levels. Toxins include, for example, bacterial toxins, fungal toxins, algal toxins, and animal toxins. Examples include microcystins produced by freshwater cyanobacteria, or venoms produced by snakes or spiders. The word “toxin” without other descriptors such as “bio” is used in this manual and is a proper technical term to specifically describe toxins of biological origin. Toxic substances that are not of biological origin are properly termed “poisons.” Typical laboratory work with very small quantities of most toxins can be performed with minimal risk to the worker. Toxins do not replicate, are not infectious, and are difficult to transmit mechanically or manually from person to person. Other characteristics that further limit the spread of toxins include the fact that many commonly employed toxins are relatively unstable in the environment (especially in the case of protein toxins) and have very low volatility. Toxins must be handled using the general and “particularly hazardous substance” sections of the LBNL Chemical Hygiene and Safety Plan (CHSP). In addition, safety and security controls (presented below) based on a risk assessment must be used for each specific laboratory operation. The main laboratory risks are accidental exposure by direct contamination of the mouth, eyes, or other mucous membranes; inadvertent aerosol generation; and needlestick or other accidents that may compromise the normal barrier of the skin. Requirements and guidelines for storage and work with toxins in the laboratory are covered and summarized below. See Section 3.3.2.5 for additional information on toxins listed in the National Select Agent Registry. • BMBL Guidelines for Work with Toxins According to Appendix I of BMBL, toxins of biological origin must be reviewed and should be incorporated into work with toxins based on a risk assessment approved by the IBC. Key criteria in the guidelines and LBNL policies: o A risk assessment should be conducted to develop safe operating procedures and a specific chemical plan. It is LBNL policy that this toxin assessment and plan should be documented in the Biosafety Work Authorization and should cover applicable topics and guidelines presented in Appendix I of BMBL. General topics should include: description of work; safety and security risks, hazards, or concerns; and safety and security controls. o Each worker must be trained in the theory and practice of toxins, with emphasis on practical hazards associated with laboratory operations. This training includes how to handle transfers of toxins or liquids containing toxin, where to place waste solutions and contaminated materials or equipment, and how to decontaminate work areas after routine operations as well as after accidental spills. o An inventory control system should be in place to account for toxin use and disposition. At LBNL, original primary containers of toxin must have LBNL chemical barcodes and be entered into the LBNL Chemical Management System. o o o Access to work areas should be controlled. Routine operations with dilute toxin solutions should be conducted under BL2 containment with the aid of personal protective equipment, laboratory hoods, biosafety cabinets, or comparable engineering controls. Work with dry toxins should be minimized or eliminated. • BMBL Toxin Agent Summary Statements Printed copies are not official versions of this manual. Before using the printed copy, verify that it is the most current version. 19
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