Work with or potential exposure to biological materials in the course of performing research or other work activities at Lawrence Berkeley National Laboratory (LBNL) must be conducted in a safe, ethical, environmentally sound, and compliant manner. Work must be conducted in accordance with established biosafety standards, the principles and functions of Integrated Safety Management (ISM), this Biosafety Manual, Chapter 26 (Biosafety) of the Health and Safety Manual (PUB-3000), and applicable standards and LBNL policies.
The purpose of the Biosafety Program is to protect workers, the public, agriculture, and the environment from exposure to biological agents or materials that may cause disease or other detrimental effects in humans, animals, or plants. This manual provides workers; line management; Environment, Health, and Safety (EH&S) Division staff; Institutional Biosafety Committee (IBC) members; and others with a comprehensive overview of biosafety principles, requirements from biosafety standards, and measures needed to control biological risks in work activities and facilities at LBNL.
This Biosafety Manual and the Biosafety Program apply to biosafety issues related to worker safety, public health, agricultural protection, and environmental protection for work activities at locations where LBNL has Environment, Safety, and Health (ES&H) management responsibilities. The work must also include:
- Biological materials, agents, and other materials of biological origin (e.g., organisms, cells, viruses, and toxins) that pose different levels of risk to humans, animals, or plants when stored or used; or
- Workers who may be exposed to disease-causing biological agents related to designated job duties (e.g., bloodborne pathogens in health care).
The Biosafety Manual addresses:
- Biosafety risk assessment and containment controls.
- Principles, programmatic elements, and controls required by ISM and the biosafety standards outlined in PUB-3000, Section 26.5.
The Biosafety Manual was written by the EH&S Division, and approved by the IBC and the EH&S Division Biosafety Officer. The EH&S Division Director provides management approval.
The Biosafety Manual is presented in a manner that:
- Further describes requirements outlined in PUB-3000, Chapter 26 (Biosafety).
- Integrates similar requirements by topic from different biosafety standards and LBNL policies, and explains when certain requirements are applicable to specific work.
- Is similar to the structure of Biosafety in Microbiological and Biomedical Laboratories (BMBL, fifth edition).
- Links to LBNL policies and biosafety regulations, standards, and guidelines available online.
Terms, acronyms, and abbreviations used in this manual are defined in the Glossary (Appendix A).
Statements used in this manual that describe needed conditions commonly use the terms “must” and “should.” In addition, sections of the manual sometimes begin by stating that the conditions presented in the section are “guidelines.” These terms are defined below:
- Must means the condition is required. Requirements are derived from LBNL ES&H standards or LBNL policies.
- Should means there is an expectation that the condition will be met unless there is an equally forceful reason for not meeting the condition, and an alternative approach that does not conflict with other requirements and accomplishes the same safety objective. When the term “should” is used in guidelines, the condition is a best-management practice, and the condition or safe alternatives will be implemented when needed to control apparent risk.
- Guidelines are a set of nonmandatory but desirable criteria, conditions, or best-management practices that should typically be considered when determining controls needed to mitigate risk.
When determining if a needed condition must or should be implemented, or is recommended, the reader of this manual should read all parts of the statement or section and use term definitions (see Appendix A, Glossary) as needed to determine the applicability of the condition to the work to be conducted.
Biosafety-related roles and responsibilities are covered in Section 26.4 and Appendix B of PUB-3000, Chapter 26 (Biosafety).
The Biosafety Officer in the EH&S Industrial Hygiene Group has primary oversight responsibility for this manual, but other groups and individuals also provide specific subject matter expertise, program management, or direction. The following groups or individuals may be contacted for additional information:
- The Industrial Hygiene Group of the EH&S Division and the Biosafety Officer at (510) 495-2768 or (510) 486-7837
- The Waste Management Group of the EH&S Division and the Medical/Biohazardous Waste Coordinator at (510) 486-7579
- The Health Services Group of the EH&S Division at (510) 486-6266
- The Training Group of the EH&S Division at (510) 495-2228
- The EH&S Division Web site at (510) 486-5514
- The Security and Emergency Operations Group of the EH&S Division at (510) 486-6234
- Division Safety Coordinators