Defines work with biological materials, evaluates biological hazards, implements biosafety containment controls, and ensures work is authorized. The responsibilities of line management are listed below.

Ensure, with the support of their designated safety representatives:

• • The Berkeley Lab Biosafety Policy and Program is 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 controlsAppropriate 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

These positions and other activity leaders are part of the safety-line-management chain responsible for adhering to all ES&H policies and safe work practices.

• • Work leads and activity leaders derive authority from formal Berkeley Lab managers and/or supervisors to ensure that day-to-day work, operations, and activities in their assigned area(s) and activities are conducted safely and within established work authorizations.
  • In addition, the principal investigator (PI) is the individual assigned authority and responsibility to direct a research experiment, project, or program that is typically funded by a grant. The PI may or may not be the supervisor of the people doing the work. But when recombinant research is being performed, the NIH Guidelines require the PI to ensure that responsibilities listed below are implemented.

Line management and PI roles and responsibilities:

Prior to initiating research:

• Initially determine required levels of physical and biological containment in accordance with Centers for Disease Control and Prevention (CDC) and National Institutes of Health (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 Work Process D.1.
• 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 each employee’s Job Hazards Analysis (JHA) identifies and categorizes the biological hazards and required controls (e.g., training courses).
• Ensure that PIs, work leads, activity leaders, and 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, Health Services Program) Ensure that Berkeley Lab personnel demonstrate proficiency in standard and special microbiological practices before working with Biosafety Level 2 (BL2) agents Obtain permits required by the U.S. Department of Agriculture (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 Program) requirements are implemented
• Supervise 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, according to 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

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 work 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 reportsWork 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

Institutional and committee roles and responsibilities are listed in the next five table rows.

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 Institutional Biosafety Committee (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

Appoints members of the IBC using the process outlined in the IBC Charter

For details on the IBC roles, responsibilities, and functions, see the IBC Charter in Work Process F.

• • 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

• • Reviews and approves work with human subjects
  • 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.

• • 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.

EHS and Protective Services biosafety-related roles and responsibilities are detailed in the table rows below.

• • 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 Security and Emergency Operations Groups.
  • 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

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 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
• Manages the Biosafety Program Self-Assessment, including performing periodic inspections to ensure biosafety requirements are followed.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
• Ensures the coordination of Work Planning and Control (WPC) Activity reviews and approvals. Reviews and approves nonrecombinant BL1 work. Reviews Exposure Control Plans (ECPs).
• Coordinates IBC meetings and functions, including:
  • Serving as a member of and 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

• Develops emergency plans for handling accidental spills and contamination of personnel and for investigating laboratory accidents involving recombinant DNA research
• Provides advice on Berkeley Lab biosafety-related security

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 this Program (Work Process D.3).

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.

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. The Group is also responsible for emergency planning and responding at Berkeley Lab. Roles and responsibilities of security and emergency management are further delineated in the ES&H Manual Emergency Management program, the Master Emergency Program Plan, and the Site Security Plan.

• Is designated by the EHS Division Director
• Has the authority and responsibility to ensure Berkeley Lab’s compliance with CDC and USDA regulations for the possession, use, or transfer of select agents and toxins
• Specific duties of the RO are further described in Appendix A of this chapter.