Washington State University
SAFETY POLICIES AND PROCEDURES MANUAL

LABORATORY SAFETY
4.20
Revised 9-07
Environmental Health and Safety
335-3041

Biological and Select Agent Safety Policy

PDF link

POLICY

All possession, use, and transportation of biological agents hazardous to human, animal, and plant health must conform to regulations and guidelines established by federal, state, and local agencies. Biological agents include infectious organisms, recombinant DNA molecules, oncogenic viruses, viroids, prions, transgenic organisms, and select agents.

PURPOSE

This biological safety policy provides faculty, staff, and students at WSU and the surrounding community with guidelines for managing risks associated with the use or control of biological agents, including infectious agents, recombinant DNA molecules, oncogenic viruses, viroids, prions, transgenic organisms, and select agents.

This policy assists the University, the Institutional Biosafety Committee (IBC), University departments, Extension, and principal investigators involved in research, teaching, and/or diagnostics in identifying and implementing appropriate safeguards.

The University Biological Safety Officer, the Office of Research Assurances (ORA), the Office of Grant and Research Development (OGRD), and Environmental Health and Safety (EH&S) have copies of the federal and state guidelines available for reference.

DEFINITIONS

Appropriate Biosafety Levels

Appropriate biosafety levels (i.e., BSL and ABSL) are levels appropriate to the biologic agent and protocol in use and in conformance with regulations or guidelines from federal, state, and local agencies including, but not limited to:

Infectious Agents

Infectious agents are all infectious organisms (e.g., bacteria, fungi, parasites, prions, viruses, and viroids) which can cause disease in humans, animals, or plants, or cause significant environmental or agricultural impact.

Infectious Materials

Infectious materials are materials that may harbor infectious organisms, such as tissues, fluids (including blood), and cells or cell cultures.

Oncogenic Viruses

Oncogenic viruses are viruses capable of inducing neoplasms in their hosts.

Prions

Prions are infectious proteinaceous particles associated with transmissible spongiform encephalopathies in animals and humans.

Recombinant DNA

Recombinant DNA is spliced DNA formed from two different sources.

Select Agents

Select agents are agents listed in the Code of Federal Regulations (including, but not limited to, 42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121) and are capable, if released, of generating a serious public health crisis or are high-consequence livestock pathogens. Transfer of select agents is limited and controlled by the National Centers for Disease Control and Prevention (CDC).

Transgenic Organisms

Transgenic organisms are animals, plants, or microbes which have been modified by genetic engineering. Genetic engineering is the transfer of DNA between living cells.

ORGANIZATIONAL STRUCTURE

In order to ensure that the requirements of the biosafety program are met, a collective and interactive effort between various University organizations, departments, and individuals at all University campuses is required. The chart in the PDF version of 4.20.3 illustrates the primary responsibilities for biosafety in relationship to the current University organizational structure. It is intended that the administrators, principal investigators, and employees at each campus work in cooperation with the specified safety groups to support the University biosafety program.

RESPONSIBILITY

Comprehensive Protection Program

The comprehensive protection program includes EH&S, the Radiation Safety Office, the Office of Research Assurances, including the biosafety officer, the Office of the Campus Veterinarian, and elements within the OGRD.

These offices work collaboratively to ensure a comprehensive, integrated protection program that ensures that risks associated with the use of animals, radioactive materials, humans research subjects, recombinant DNA, and genetically-modified organisms do not exceed the benefits accrued from the University activities. These specific elements are governed by a variety of state and federal laws and regulations. Many of these offices coordinate activities with Presidential committees including the Radiation Safety Committee, the Institutional Review Board for Human Subjects Research, the Conflict of Interest Review Board, the Institutional Animal Care and Use Committee, and the Institutional Biosafety Committee.

Offices of Research and Finance and Administration

The Office of the Vice President for Research and the Office of the Senior Associate Vice President for Finance and Administration implement the Biological and Select Agent Safety Policy. The biosafety function is part of the comprehensive protection program. (See above.)

The Vice President for Research or representative and the Senior Associate Vice President for Finance and Administration or representative are jointly responsible to:

Office of Research Assurances

The Office of Research Assurances:

Institutional Biosafety Committee (IBC)

The University's Institutional Biosafety Committee (IBC):

IBC approval to conduct research is required regardless of funding source or submission of a BioSafety Approval Form (BAF).

To obtain copies of the BAF and instructions, select the Forms link on the Biosafety website at:

http://www.bio-safety.wsu.edu/biosafety/

WSU Biological Safety Officer (BSO)

The WSU Biological Safety Officer (BSO):

Institutional Biosafety Committee (IBC),
Institutional Animal Care and Use Committee (IACUC),
University Health and Safety Committee (UH&S),
Human Subjects Institutional Review Board (IRB),
Environmental Health and Safety (EH&S), and
Facilities Services, Operations.
Interpretation of regulations,
Biocontainment practices,
Biosafety risk assessment,
Development of standard operating procedures (SOPs),
Development of the laboratory biosafety manuals, and
Use of biocontainment equipment.

Environmental Health and Safety (EH&S)

The Department of Environmental Health and Safety (EH&S) serves as a biosafety resource for laboratory, public health, and occupational settings.

Laboratory Biosafety

EH&S:

Public Health Biosafety

The following SPPM sections provide policies and procedures regarding public health biosafety issues:

Hantavirus

See 6.33.

Bird and Bat Waste

See 6.35.

Food Safety and Sanitation

See 6.20.

Sewage Spills

See 6.70.

Occupational Health

See 2.44 regarding the bloodborne pathogen safety policy and procedures.

Facilities Services, Operations

See 4.24 regarding the disposal of biohazard wastes.

See 5.40 regarding the transport and shipment of hazardous materials, biological materials, and dangerous goods.

Central Receiving

Central Receiving monitors shipments of dangerous goods; e.g., infectious, biohazardous, diagnostic; to ensure that Department of Transportation regulations 49 CFR and select agent regulations 42 CFR Part 72.6 and Appendix A are followed for all packages shipped from and received at Central Receiving.

Central Receiving is not held responsible for dangerous goods shipments picked up directly by carriers from University departments. See 5.40.

Departmental Administrators

Departmental administrators supervise their employees, students, and visitors with regard to biological risks. The department chair:

Principal Investigator

WSU assigns primary responsibility for enforcing rules and procedures for proper control of biologically hazardous agents to the principal investigators and supervisors. These duties include:

Employees

Employees assigned to work with biologically hazardous materials are responsible for complying with safety rules and procedures. These duties include: