Biosafety Manual PDF - Lawrence Berkeley National Laboratory

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Biosafety Manual IBC-approved version (May 18, 2010) Section VIII-G of BMBL contains information and guidance on specific toxins. When applicable, this guidance must be reviewed and should be incorporated into the work in accordance with the IBC-approved risk assessment. 3.3.2.5 Select Agents and Toxins Select agents and toxins are specific pathogenic agents and toxins regulated by the HHS-CDC and The USDA-APHIS due to their potential threat (e.g., as biological weapons) to human, animal, and plant health. Specific genetic elements, recombinant nucleic acids, and recombinant organisms that may pose a similar threat are also regulated. Appendix B, Section B.2, of this manual provides the list of select agents and toxins and additional toxin information. Possession, use, storage, or transfer of select agents and toxins must be conducted in compliance with the HHS-CDC and USDA-APHIS regulations related to human, plant, and animal select agents and toxins. Specific controls for select agents are detailed in LBNL’s Biosafety, Security, and Incident Response Plan for Select Agents, a controlled document. Controls for select agents have also been integrated into the overall biosafety program described in this manual. See the National Select Agent Registry (NSAR) Program Web site for additional information on select agents provided by HHS-CDC and USDA-APHIS. The NSAR Program oversees possession of select agents and toxins for the HHS-CDC Division of Select Agents and Toxins and the USDA-APHIS Agricultural Select Agent Program. 3.3.2.6 Prions A prion is an infectious agent composed of protein. All such agents discovered to date propagate by transmitting a misfolded protein; the protein does not itself self-replicate and the process is dependent on the presence of the polypeptide in the host organism. The misfolded form of the prion protein has been implicated in prion diseases known as transmissible spongiform encephalopathies (TSEs). TSEs are neurodegenerative diseases that affect humans and a variety of domestic and wild animal species. Examples are Creutzfeldt-Jakob disease (CJD) in humans and bovine spongiform encephalopathy (BSE), also known as mad cow disease in cattle. All known prion diseases affect the structure of the brain or other neural tissue, are currently untreatable, and are always fatal. Normal and diseased (misfolded) prions. Source: ScienceBlogs, Basic Concepts: Prions, by Shelley Batts (February 11, 2007). Printed copies are not official versions of this manual. Before using the printed copy, verify that it is the most current version. 20
Biosafety Manual IBC-approved version (May 18, 2010) Prion diseases are transmissible by inoculation or ingestion of infected tissue or homogenates. Prion infections usually occur in brain or other central nervous system tissues, and to a lesser extent in lymphoid tissues including spleen, lymph nodes, gut, bone marrow, and blood. Section VIII, Appendix H, of BMBL provides an agent summary statement that includes guidelines for prion diseases. When applicable, this guidance must be used to incorporate controls based on a risk assessment into the Biosafety Work Authorization. 3.3.3 USDA-Regulated Materials, Organisms, and Agents The USDA-APHIS defends America’s animal and plant resources from agricultural pests and diseases by regulating materials, organisms, or agents that may harm domestic or native animals or plants, or natural resources. These materials, organisms, or agents may cause harm directly (e.g., predator or pathogen) or indirectly (e.g., vector). General examples include specific animals, plants, genetically engineered organisms, animal pathogens, plant pathogens, soil that may contain such pathogens, and agents that pose a severe threat. The transfer, storage, use, and disposal of APHIS-regulated materials at LBNL must be conducted in accordance with APHIS regulations. Generally, APHIS requires a permit or other document to import, export, or store regulated materials from or to locations outside the continental United States (U.S.) or between U.S. states. APHIS permits are issued to individuals and are not transferrable to others. The APHIS permit and sometimes an accompanying “compliance agreement” dictate specific controls and limitations when working with regulated materials. Individuals responsible for the transfer, storage, use, or disposal of such materials will obtain permits when required, ensure that the materials and permits are covered in the LBNL Biosafety Work Authorization, and ensure that specific requirements in the permit and compliance agreement are implemented. Materials, organisms, and agents that threaten animal and plant health are regulated by branches of the USDA-APHIS and examples are listed below in Table 4. Additional agency requirements and Web links for more information are detailed in Appendix I, Section I.2.2, of this manual. See Section 3.3.2.5 above for more information on select agents and toxins. Printed copies are not official versions of this manual. Before using the printed copy, verify that it is the most current version. 21
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