Role |
Responsibility |
Line
management |
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. |
Division
directors |
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 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, and principal investigators |
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
|
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 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 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
|
Institutional |
Institutional and
committee roles and responsibilities are listed in the next five table rows. |
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 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
|
Laboratory
Director |
- Appoints members of the IBC using
the process outlined in the IBC Charter
|
Institutional
Biosafety Committee (IBC) |
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
|
Human Subjects
Committee (HSC) |
- 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.
|
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 and Protective Services biosafety-related
roles and responsibilities are detailed in the table rows below. |
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 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
|
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 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:
o Presenting and
interpreting applicable federal and state government, contract, and funding
regulations and standards
o 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
o 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
o Providing
institutional requirements to manage and oversee the Biosafety Program and
assist line managers in effective implementation and continuous improvement
- Manages the Biosafety Program
Self-Assessment, including performing periodic inspections to ensure
biosafety requirements are followed.
- 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:
o Serving as a
member of and an advisor to the IBC
o Reporting on the
status of the Biosafety Program to the IBC
o 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
|
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 this 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. |
Security and
Emergency Services |
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. |
Responsible
Official (RO) for Select Agents |
- 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.
|