Lawrence Berkeley National Laboratory masthead LBNL Home A-Z Index U.S. Department of Energy logo Phone Book Jobs Search

RPM

REQUIREMENTS AND POLICIES MANUAL

Search the RPM
 
Home

Biosafety Policy

    Title:

    Biosafety Policy

    Publication date:

    9/4/2015

    Effective date:

    8/27/2014

    BRIEF

    Policy Summary

    Work with or exposure to biological materials at Berkeley Lab must be conducted in a safe, ethical, environmentally sound manner, complying with established biosafety standards and the principles and functions of Integrated Safety Management (ISM).
    The Biosafety Policy applies to worker safety, public health, agricultural protection, and environmental protection. Biosafety work involves:

    • Biological materials, agents, and other materials of biological origin (e.g., organisms, cells, viruses, and toxins) that pose varying levels of risk or disease to humans, animals, or plants when stored or used
    • Workers who may be exposed to disease-causing biological agents related to designated job duties (e.g., blood-borne pathogens in health care)

    Work with biological materials must:

    • Be planned, assessed, and authorized by documenting, reviewing, and approving the work scope, hazards, risk assessment, and controls based on requirements and safety
    • Implement standard and specific biosafety containment controls for work, storage, transfer, transportation, decontamination, and incident response
    • Be periodically assessed to determine if the hazards are being properly controlled and whether improvement is needed

    Who Should Read This Policy

    Berkeley Lab employees, affiliates, subcontractors, and line management, or anyone with oversight responsibilities for work involving biological materials of concern.

    Examples of persons with oversight responsibility include line management, division safety coordinators, Environment/ Health/Safety (EHS) Division staff, and Institutional Biosafety Committee (IBC) members. It is particularly important that this policy be read by workers, work leads, supervisors, activity leads, project leads, and principal investigators assigned to laboratory work with biological materials or work involving exposure to blood-borne pathogens.

    To Read the Full Policy, Go To:

    The POLICY tab on this wiki page

    To Read the ES&H Program Details, Go To:

    http://www.lbl.gov/ehs/biosafety/manual/index.shtml

    Contact Information

    Biosafety Officer
    EHS Division

    Title:

    Biosafety Policy

    Publication date:

    9/4/2015

    Effective date:

    8/27/2014

    POLICY

    A. Purpose

    The purpose of the Biosafety Policy is to protect workers, the public, agriculture, and the environment from exposure to biological agents or materials that may cause disease or other risks to humans, animals, or plants. This policy provides an overview of biosafety principles, requirements of biosafety standards, and measures to control biological risks in work activities and facilities at Lawrence Berkeley National Laboratory (Berkeley Lab).

    B. Persons Affected

    Berkeley Lab employees, affiliates, subcontractors, and line management, or anyone with oversight responsibilities for work involving biological materials of concern.

    Examples of persons with oversight responsibility include line management, division safety coordinators, Environment/ Health/Safety (EHS) Division staff, and Institutional Biosafety Committee (IBC) members. It is particularly important that this policy be read by workers, work leads, supervisors, activity leads, project leads, and principal investigators assigned to laboratory work with biological materials or work involving exposure to blood-borne pathogens.

    C. Exceptions

    The Biosafety Program generally does not apply to non-research work with or exposure to biological materials commonly experienced by the general public and not resulting from assigned job duties.

    D. Policy Statement

    Work with or exposure to biological materials at Berkeley Lab must be conducted in a safe, ethical, and environmentally sound manner, complying with established biosafety standards and the principles and functions of Integrated Safety Management (ISM).


    Starting and Conducting Work Safely (Work Process A)
    Work, hazards, and controls associated with biological materials must be defined, assessed, approved, controlled, and periodically reassessed in accordance with Berkeley Lab and Biosafety Program policies and procedures. Work Process A summarizes the process of starting and conducting work. The biosafety work review and authorization process is described in greater detail in Work Process B.


    Work and Risk Assessment (Work Process B)
    The scope, hazards, risks, and requirements for work involving specific biological materials and agents must be defined and assessed before work begins. This process includes the following Berkeley Lab and standard biosafety risk-assessment processes:

    Biosafety Principles and Levels (Work Process C)
    Standard sets of containment controls for research with biological materials must be selected, customized when needed, and implemented. These containment controls are categorized as:

    Researchers who work with biological materials must implement containment controls in accordance with established biosafety categories, levels, and criteria. A biosafety level (BL) is a standard combination of practices, safety equipment, and facilities to safely contain biohazardous materials or agents used in the work. Typical categories and levels are:

    Specific Biosafety Controls  (Work Process D)        
    Specific biosafety controls and related requirements must be assessed, selected, and implemented. Controls include:

    Assessment and Improvement (Work Process E)
    Work with biological materials must be periodically assessed to determine if hazards are being properly controlled and whether improvement should be initiated.

    Institutional Biosafety Committee (Work Process F)
    The Institutional Biosafety Committee (IBC) provides institutional assurance that research with biological materials is conducted safely and in accordance with the IBC Charter and National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and DOE standards. The IBC provides oversight, administration, and review of Berkeley Lab policies and projects involving research with biological materials.

    The IBC uses a graded process to review, approve, and monitor all Laboratory research projects involving biological materials that may pose risk to plants, animals, or humans. This process is detailed in the ES&H Manual, Chapter 26, Work Process D.1, Work Authorizations. While the IBC performs initial and periodic reviews of biosafety documentation, researchers and line managers must identify and submit documentation to the Committee before and periodically during the research.

    E. Roles and Responsibilities

    Biosafety roles and responsibilities are implemented in accordance with the principles of Integrated Safety Management (ISM), NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), Biosafety in Microbiological and Biomedical Laboratories (BMBL), and other standards. Berkeley Lab's ISM principles, roles, and responsibilities are defined in a hierarchy of policies, including the Requirements and Policies Manual (RPM), the Integrated Environment, Safety & Health Management Plan (PUB-3140), and the ES&H Manual (PUB-3000) Work Planning and Control program. In this section, roles and responsibilities are further defined as applied to biosafety, and are divided into three functional categories: line management, institutional, and technical support.

    Role

    Responsibility

    Line management

    Defines work with biological materials, evaluates the biological hazards, implements biosafety containment controls, and ensures work is authorized

    Division director

    Ensures that:

    • Berkeley Lab biosafety policies are observed within his or her division
    • The division's research projects involving biological materials are evaluated through the IBC review process to identify potential hazards and implement specific safety controls
    • Appropriate facilities are available to control biological hazards
    • Line management and all personnel authorized to conduct biological work have training commensurate with the proposed project
    • Self-assessments for biosafety are carried out, and safety deficiencies are identified and promptly corrected

     

    Supervisors, managers, work leads, activity leads, and principal investigators

    Prior to initiating research:

    • Initially determine required levels of physical and biological containment in accordance with CDC and NIH standards
    • Select appropriate microbiological practices and laboratory techniques for the work
    • Ensure that research with biological material is documented, reviewed by the IBC, and authorized as required in ES&H Manual Chapter 26, Work Process D.1, Work Authorizations
    • Ensure that biological hazards and concerns are identified, and appropriate required biosafety controls are defined and implemented
    • Ensure workers have access to authorized documents and protocols that describe potential biohazards and necessary precautions
    • Ensure that the Job Hazards Analysis (JHA) identifies and categorizes the biological hazards and required controls (e.g., training courses)
    • Ensure that workers complete institutional training as required
    • Ensure that workers are appropriately trained in good microbiological techniques, biosafety, and emergency procedures for handling accidental spills and personnel contamination
    • Ensure that each worker is aware of the hazards and that each worker's competence and on-the-job training is commensurate with his/her work assignment
    • Ensure that workers are advised of, and complete, any recommended or required medical precaution or surveillance (e.g., vaccination) as detailed in the authorization document or Berkeley Lab policy  (e.g., ES&H Manual Chapter 3, Health Services)
    • Ensure that Berkeley Lab personnel demonstrate proficiency in standard and special microbiological practices before working with BL2 agents
    • Obtain permits required by the USDA and/or the U.S. Public Health Service (PHS) for work with certain animal and plant pathogens

    While research is conducted:

    • Ensure that authorizations and applicable EHS policy (e.g., the Biosafety Manual) requirements are implemented
    • Supervise the workers to ensure that required safety practices and techniques are employed
    • Ensure the integrity of physical containment (e.g., biological safety cabinets) and biological containment (e.g., purity and genotypic and phenotypic characteristics) are maintained
    • Ensure that preventative-maintenance program activities are performed during indicated dates, and that repairs are done to ensure the safety envelope is maintained
    • Report significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to the Biosafety Officer and division director
    • Comply with shipping requirements for biological materials
    • Communicate in writing to the Biosafety Officer any protocol changes that substantially modify the research procedures upon which approval was originally based
    • Remain in communication with the IBC throughout the project as necessary to report changes, problems, or concerns
    • Update work authorization documentation and submit it to the IBC for review in accordance with the document renewal cycles or if significant changes occur in the work
    • Revise the authorization as necessary and submit it for extension or re-approval

    Division Safety Coordinators (DSCs)

    Prior to initiating research:

    • Help develop and implement biosafety training if needed to meet specific risks within their divisions
    • Consult and coordinate with the EHS Division (i.e., Biosafety Officer) and other resources as needed
    • Facilitate the implementation of biosafety controls

    During the conduct of the research:

    • Support line managers or activity leads as an assurance mechanism, and assess the adequacy of biosafety controls by:
      • Performing frequent inspections
      • Monitoring research activities/operations, as defined by the division's ISM Plan
    • Coordinate and manage required biosafety documentation, including:
      • Biosafety training and JHAs (to help ensure timely completion)
      • Walkaround biosafety inspection reports
      • Work authorizations (e.g., Biological Use Notifications [BUNs], Biological Use Registrations [BURs], and Biological Use Authorizations [BUAs])
      • Hazard Management System (HMS)
      • Occurrence reporting and 10 CFR 851 reporting on biosafety issues
      • Medical/biohazardous waste records
      • The corrective-action process for the division, such as ensuring that biosafety items entered in the Corrective Action Tracking System (CATS) are appropriate, assigned to the correct individual, addressed and corrected as scheduled, and closed out

    Before the expiration of the authorization:

    • Assist in coordinating the extension or reapproval of all authorizations

    Berkeley Lab

    According to the NIH Guidelines, Berkeley Lab must:

    • Establish and implement policies for the safe conduct of recombinant DNA research, and that ensure compliance with the NIH Guidelines
    • ·        Establish an IBC that meets the requirements of the NIH Guidelines
      •  The Committee’s responsibilities need not be restricted to recombinant DNA.
      • Ensure that the IBC reports directly to the Laboratory Director
      • As necessary, appoint a Biosafety Officer as a member of the IBC
      • Ensure that the IBC has adequate expertise and training on applicable research operations performed at Berkeley Lab
      • Assist and ensure compliance with the NIH Guidelines by safety line management in conducting research
      • Ensure appropriate training in safety and implementation of NIH Guidelines for the IBC Chair and members, the Biosafety Officer, and other containment experts (when applicable), safety line managers, and Laboratory staff
      • Determine the necessity for health surveillance of personnel involved with individual recombinant DNA projects, and if appropriate, conduct a health surveillance program for such projects
      • Report significant problems, violations of the NIH Guidelines, or significant research-related accidents and illnesses to the NIH/Office of Biotechnology Activities (OBA) within 30 days, unless Berkeley Lab determines that line management or the IBC has already filed a report

    Institutional Biosafety Committee (IBC)

    • Oversees, administers, and reviews Berkeley Lab policies and projects involving research with biological materials that may pose safety, health, or environmental risks
    • Reports to the Laboratory Director to ensure institutional assurance that research is conducted safely
    • Assists and advises researchers and line managers in meeting their responsibilities to ensure that biological aspects of research are conducted in a safe manner using established biosafety standards, principles, and functions of ISM and work authorization. Safe research includes worker safety, public health, agricultural and environmental protection, ethics, and compliance with applicable biosafety standards and Laboratory policies.
    • Identifies, documents, reviews, and approves work with biological materials and controls using a graded process, as detailed in the work authorization section of this program

    Human Subjects Committee (HSC)

    • Handles the review and approval process
    • Provides assurance to the U.S. Department of Health and Human Services that Berkeley Lab will comply with all federal regulations for the protection of human research subjects

    For more information on the HSC, see the ES&H Manual Research with Human and Animal Subjects Program.

    Animal Welfare and Research Committee (AWRC)

    • Reviews and approves any research involving warm-blooded vertebrate animals
    • Determines whether the proposed work meets acceptable standards for the care, treatment, and use of animals in research
    • Assesses topics such as animal housing, handling, sanitation, nutrition, availability of water, veterinary care, protection from extreme weather and temperatures, waste disposal, and pest control

    For more information on the AWRC, see the ES&H Manual Research with Human and Animal Subjects Program.

    Environment/Health/Safety (EHS) Division Director

    • Provides overall technical guidance and resources in support of the Biosafety Program. This includes interaction with the Health & Safety Department, Health Services, Waste Management, and Protective Services’ Security Operations and Emergency Management.
    • Ensures external or independent audits of the Biosafety Program are conducted as needed, and uses this information for the effective allocation of resources
    • Is alert to changing standards, changing research programs, and new institutional initiatives in order to maintain the quality of Laboratory expertise and resources

    EHS Health & Safety Department and Biosafety Officer

    The Biosafety Program is administered through the Health & Safety Department of the EHS Division. The Biosafety Officer implements the Biosafety Program and coordinates the IBC. Other subject matter experts assist the Biosafety Officer to implement and maintain the Berkeley Lab Biosafety Program.

    The Health & Safety Department Management:

    • Administers the primary functions of the Biosafety Program
    • Provides oversight, advice, and guidance to the Biosafety Officer
    • Monitors resource allocations to ensure they are adequate and being used effectively and efficiently

     

    The Biosafety Officer/Deputy Biosafety Officer:

    • Develops and maintains the primary structure and function of the Biosafety Program based on adherence to technical standards that provide the basis for line management to execute their roles and meet their responsibilities
    • Works with other EHS Division technical staff to develop and maintain a compliance-based program for all aspects of biosafety (e.g., biohazardous and medical waste and medical surveillance) that effectively integrates the aims of the Biosafety Program into work that involves biological materials by:
    • Presenting and interpreting applicable federal and state government, contract, and funding regulations and standards
    • Providing a means for meeting and applying external standards in a manner that allows diverse research groups and individuals to tailor biological hazard controls to their specific needs
    • Providing line managers and workers with the information and tools needed to identify risks and implement controls and work authorizations to achieve a biologically safe workplace
    • Providing institutional requirements to manage and oversee the Biosafety Program and assist line managers in effective implementation and continuous improvement
    • Serving as a member of, and as an advisor to, the IBC
    • Reporting on the status of the Biosafety Program to the IBC
    • Reporting to the IBC and the Laboratory significant problems, violations of NIH Guidelines, and significant research-related accidents or illnesses of which the Biosafety Officer becomes aware, unless the Biosafety Officer determines that a report has already been filed by safety line management
    • Provides advice on Berkeley Lab biosafety-related security
    • Manages the Biosafety Program Self-Assessment, including performing periodic inspections to ensure biosafety requirements are followed.
    • Ensures the coordination of BUA, BUR, and BUN reviews and approvals
    • Reviews and approves nonrecombinant BL1 work covered in BUNs. Reviews Exposure Control Plans (ECPs)
    • Coordinates IBC meetings and functions, including:
    • Develops emergency plans for handling accidental spills and the contamination of personnel, and for investigating laboratory accidents involving recombinant DNA research

    EHS Health Services Group

    Develops and implements the occupational health programs needed to maintain the health of employees exposed to biological materials. Roles and responsibilities of the Health Services Group are further delineated in the ES&H Manual Health Services Program and the Occupational Health and Immunization section of the Biosafety Program, Work Process D.3.

    EHS Waste Management Group

    Develops and maintains the waste-disposal programs needed and required to properly collect and dispose of medical/biohazardous waste that is generated during work with biological materials at Berkeley Lab. Roles and responsibilities of the Waste Management Group are further delineated in the ES&H Manual Waste Management Program.

    Protective Services Security Operations and Emergency Management

    Develops and maintains the core security and emergency-management programs required to maintain the security of work and research with biological materials conducted at Berkeley Lab. Protective Services is also responsible for emergency planning and responding at Berkeley Lab. Roles and responsibilities of Security Operations and Emergency Management are further delineated in the ES&H Manual Emergency Management Program, the Master Emergency Program Plan, and the Site Security Plan.

    F. Definitions/Acronyms

    Terms, acronyms, and abbreviations used in the Biosafety Program at Berkeley Lab are defined in the following table.

    Term

    Definition

    Biohazard

    A biological material or condition that presents potential hazard to the health of humans or other organisms, either directly through infection or indirectly through damage to the environment

    Biohazardous waste

    A waste that requires inactivation (i.e., decontamination) in an approved manner prior to disposal but is not regulated by the California Department of Health Services as regulated medical waste. See the Medical and Biohazardous Waste Generator's Guide (PUB-3095) for additional information.

    Biological etiologic agent

    An agent of biological origin (e.g., bacterium, fungus, parasite, virus, etc.) that causes disease in humans (i.e., is pathogenic to humans)

    Biological materials

    A broad range of organisms, cells, viruses, and other materials of biological origin that pose varying levels of risks to plants, animals, or humans

    Biosafety or biological safety

    The general administrative and physical safety measures and efforts employed in a certain environment (e.g., Berkeley Lab) 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, plants, or animals

    Biosafety level (BL)

    A standard combination of practices and techniques, safety equipment, and facilities to safely contain biohazardous materials or agents used in work, as specified by Biosafety in Microbiological and Biomedical Laboratories (BMBL) and the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The NIH Guidelines use the acronym BL, and BMBL uses the acronym BSL. "Biosafety level" and "BL" may be used generally to apply to any work with biological materials, but BL, when used without additional letters or words, technically applies only to laboratory BLs. When other letters or words are added to the BL acronym, other containment categories are indicated (e.g., BL-Large Scale, BL-P for plants, and BL-N for animals).

    Biosafety Officer

    A person in the EHS Division who oversees the development and maintenance of the primary structure and function of the Biosafety Program in accordance with the biosafety standards

    Decontamination

    The process of reducing or inactivating biological contaminants or components to an acceptable level to reduce or eliminate the possibility of transmission of pathogens to undesired hosts such as laboratory workers, the general public, and other organisms in the environment

    Exposure Control Plan (ECP)

    An authorization document used at Berkeley Lab to define work, hazards, and controls in accordance with the requirements of the OSHA Bloodborne Pathogens Standard for work with or potential exposure to blood-borne pathogen materials. The BUA is the ECP for work that pertains to research.

    Infectious agent or human pathogen

    Infectious microbials (e.g., bacteria, protozoa, fungi, viruses, etc.) or other agents (e.g., prions) that cause disease in healthy humans

    Infectious substances

    Materials regulated for shipping by the Department of Transportation (DOT) and the International Air Transport Association (IATA) that are known to be or are reasonably suspected to contain an animal or human pathogen. A pathogen is a virus, microorganism (including bacteria, plasmids, or other genetic elements), proteinaceous infectious particle (prion), or recombinant microorganism (hybrid or mutant) known or reasonably expected to cause disease in humans or animals.

    Laboratory biosafety level (BL)

    A standard combination of practices and techniques, safety equipment, and facilities to safely contain biohazardous materials or agents used in laboratory work

    Large Scale (BL-Large Scale)

    A term used in the NIH Guidelines and Berkeley Lab Biosafety Program to describe uses of and containment levels for organisms containing recombinant DNA molecules involving a quantity of culture greater than 10 liters

    Medical waste

    Waste generated or produced as a result of diagnosis, treatment, or immunization of human beings or animals; research pertaining to the diagnosis, treatment, or immunization of human beings or animals; or the production or testing of biologicals. See the Medical and Biohazardous Waste Generator's Guide (PUB-3095) for additional information.

    G. Recordkeeping Requirements

    Biosafety cabinet (BSC) records of locations and certifications are maintained by the EHS Division in the Ventilation Database. The BSC certification sticker is also posted on the BSC.

    Biosafety regulatory reports are developed by the EHS Biosafety Officers. Examples include: The IBC annual report to the NIH Office of Biotechnology Activities (OBA), the IBC annual report to the Laboratory Director, and the IBC annual report to DOE Berkeley Site Office on the inventory and status of biological etiologic agents.

    Biosafety Program Self-Assessment Program reports and records are managed by the EHS Biosafety Officer. Division self-assessment reports are managed by the research divisions.

    Biosafety Work Authorizations and approved activities are maintained in the Biosafety Authorization System (BAS) and the newer Activity Manager system. These authorizatons and activities also serve as the required IBC registration document for recombinant work, the laboratory-specific biosafety manual for Biosafety Level (BL) 2 work, and the exposure control plan (ECP) for work with blood-borne pathogen materials.

    Health records for employees (e.g., hepatitis B vaccinations and medical surveillance) are managed by the EHS Health Services Group through the Comprehensive Health, Environment, and Safety System (CHESS) and employee medical files. Completion of the hepatitis B vaccination requirements for each employee is recorded as completion of EHS0745 Hepatitis B Medical Surveillance in the employee training profile and Activity Manager.

    Incident reports of worker exposures, injuries, or illnesses are reported in the Berkeley Lab accident reporting system. Biosafety-related incidents, such as worker exposures or releases outside of secondary containment, are also documented by the Biosafety Officers.

    Institutional Biosafety Committee (IBC) records are developed and managed by the EHS Biosafety Officers. Examples include: meeting minutes, comments on authorizations, IBC member information, and the annual report to the Laboratory Director and NIH OBA.

    Medical/biohazardous waste records are managed by the EHS Waste Management Group.

    Training records and requirements related to biosafety are managed and displayed through the Berkeley Lab Training and Activity Manager systems. These records are managed through each employee's training profile, each online Biosafety Work Authorization, and in Activity Manager.

    U.S. Department of Agriculture (USDA) permits or other operation-specific permits are the responsibility of the employee who signs the permit and are attached to Biosafety Work Authorizations or activities in Activity Manager.

    H. Implementing Documents

    Document Number

    Title

    Type

    07.07.004.001

    Biosafety

    Program

    07.01.001.000

    General ES&H Requirements, Responsibilities, and Work Practices

    Program

    07.05.001.000

    Immunization against Biosafety Hazards

    Policy

    07.02.003.001

    Work Planning and Control

    Program

    07.07.024.001

    Personal Protective Equipment (PPE)

    Program

    07.10.002.001

    Waste Management

    Program

    03.02.001.001

    Research with Human and Animal Subjects

    Program

    07.04.001.001

    EHS Training Program

    Program

     

    Berkeley Lab Export Control Resources

    Website

     

    Emergency Response Guide (wall posting)

    Guide

     

    Berkeley Lab Planning and Preparedness: Protective Services Emergency Management Program

    Website

    07.07.005.001

    Chemical Hygiene and Safety Plan

    Program

     PUB-3095

    Medical and Biohazardous Waste Generator's Guide, Berkeley Lab, latest revision

    Guidelines

     

    Site Security Plan for the Lawrence Berkeley National Laboratory

    Plan

    tbd

    Biosafety Work Authorization

    Form

    07.02.001.001

    Work Planning and Control

    Program

    I. Contact Information

    Biosafety Officer
    EHS Division

    J. Revision History

    Date

    Revision

    By whom

    Revision Description

    Section(s) affected

    Change Type

    1/2/2012

    1

    Wisherop

    Rewrite for wiki

    All

    Minor

    4/25/2012

    2

    King

    Rewrite for wiki

    All

    Minor

    9/4/2015

    2.1

    King

    Periodic three-year review

    All

    Minor

    DOCUMENT INFORMATION

    Title:

    Biosafety Policy

    Document number

    07.07.004.000

    Revision number

    2.1

    Publication date:

    9/4/2015

    Effective date:

    8/27/2014

    Next review date:

    9/4/2018

    Policy Area:

    Industrial Hygiene and Safety

    RPM Section (home)

    ESH

    RPM Section (cross-reference)

    None

    Functional Division

    EHS

    Prior reference information (optional)

    ES&H Manual, Chapter 26, Biosafety

    Source Requirements Documents

    • 7 CFR 331 and 9 CFR 121, Possession, Use, and Transfer of Select Agents and Toxins, U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS)
    • 9 CFR Parts 92, 94, 95, 96, 122, and 130 (note especially Part 122, Organisms and Vectors). Importation of Etiologic Agents of Livestock, Poultry, and Other Animal Diseases; USDA/APHIS
    • 10 CFR 851, Worker Safety and Health Program, Department of Energy (DOE)
    • 29 CFR 1904.8, Recording Criteria for Needlestick and Sharps Injuries, Occupational Safety and Health Administration (OSHA)
    • 29 CFR 1910.1030, Bloodborne Pathogens, OSHA
    • 42 CFR 73, Select Agents and Toxins, Department of Health and Human Services (HHS)
    • 49 CFR 171.8, Definitions and Abbreviations; 173.134.1, Infectious Substance; and 173.6, Materials of Trade Exceptions, Hazardous Materials Regulations (HMR), U.S. Department of Transportation (DOT)
    • Biosafety in Microbiological and Biomedical Laboratories, fifth edition, Centers for Disease Control (CDC) and National Institutes of Health (NIH)
    • California Health and Safety Code, Sections 117600–118360, California Medical Waste Management Act

    Other Driving Requirements

    • 42 CFR 71, Foreign Quarantine, Part 71.54, Etiological Agents, Hosts, and Vectors; U.S. Public Health Service (PHS)
    • 7 CFR 330, Federal Plant Pest Regulations; General; Plant Pests; Soil, Stone, and Quarry Products; Garbage, Importation of Plant Pests, USDA/APHIS
    • NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, National Institutes of Health (NIH), Federal Register (current version)
    • Laboratory Biosafety Manual, 2nd ed. (revised), Interim Guidelines, World Health Organization (WHO), Geneva 2003, as applicable to biological etiologic agents

    Implementing Documents

    Document Number

    Title

    Type

    07.07.004.001

    Biosafety

    Program

    07.01.001.000

    General ES&H Requirements, Responsibilities, and Work Practices

    Program

    07.05.001.000

    Immunization against Biosafety Hazards

    Policy

    07.02.003.001

    Work Planning and Control

    Program

    07.07.024.001

    Personal Protective Equipment (PPE)

    Program

    07.10.002.001

    Waste Management

    Program

    03.02.001.001

    Research with Human and Animal Subjects

    Program

    07.04.001.001

    EHS Training Program

    Program

     

    Berkeley Lab Export Control Resources

    Website

     

    Emergency Response Guide (wall posting)

    Guide

     

    Berkeley Lab Planning and Preparedness: Protective Services Emergency Management Program

    Website

    07.07.005.001

    Chemical Hygiene and Safety Plan

    Program

     PUB-3095

    Medical and Biohazardous Waste Generator's Guide, Berkeley Lab, latest revision

    Guidelines

     

    Site Security Plan for the Lawrence Berkeley National Laboratory

    Plan

    tbd

    Biosafety Work Authorization

    Form

    07.02.001.001

    Work Planning and Control

    Program

    • No labels

    Adaptavist ThemeBuilder EngineAtlassian Confluence