Environmental Health and Safety

a. It is the policy of the university that all research and teaching involving biohazardous materials will be conducted in conditions appropriate to the biosafety level (BSL) to protect the academic as well as the greater community.

b. Currently, no facilities at SDSU meet the minimum criteria for Biosafety Level 4 (BSL 4); therefore, this level of work is prohibited.

c. The SDSU Institutional Biosafety Committee (IBC) must approve all activities involving the use of BSL 2 and 3 agents. Biological Use Authorization (BUA) is required for BSL 2 and 3 agents.

d. All research involving infectious agents shall follow the guidelines prescribed in the Centers for Disease Control (CDC) and National Institutes of Health (NIH) publication Biosafety in Microbiological and Biomedical Laboratories (4th Ed., 1999) (referred to hereafter as BMBL).

e. All research involving select agents and toxins shall follow the requirements prescribed in the Code of Federal Regulations

(42 CFR Part 73). Select agents and toxins require special registration with the CDC. Contact Environmental Health and Safety (EHS) for registration information.

(1) All research involving R-DNA shall follow the guidelines set forth in the most recent edition of the NIH publication NIH Guidelines for Research Involving Recombinant DNA Molecules (referred to hereafter as the NIH Guidelines).

(a) Projects involving R-DNA molecules that are listed as “EXEMPT” by the NIH Guidelines do not require NIH registration but must be approved by the IBC if the project involves BSL 2 or 3 agents.

(b) Projects that are not exempt require NIH registration as well as IBC approval.

(2) The Biohazard Control Program Manual will be the basis for general biosafety guidelines in the laboratory. Laboratory personnel will be expected to follow practices outlined in this manual and prudent practices specific to the projects in which they are involved.

(3) Principal Investigators (PIs) will be subject to committee review and disciplinary action for non-compliance with policies and practices outlined in this manual.

a. Forming and maintaining an active IBC.

b. Ensuring that the IBC operates in conformance with applicable agency guidelines and regulations.

a. Establishing, monitoring and enforcing policies that meet or exceed applicable guidelines and regulations for use of biohazardous materials conducted at or sponsored by SDSU.

b. Approving the Biohazard Control Program Manual developed by the Biosafety Officer (BSO) and periodically reviewing the effectiveness of the manual.

c. Reviewing and approving proposed research activities that use biohazardous materials designated as BSL 2 or 3 or that are either exempt or non-exempt from NIH Recombinant DNA Guidelines. The review shall include an independent assessment of the containment required (practices, procedures, facilities and equipment used to safely manage biohazardous materials) and an assessment of the facilities, training and expertise of personnel involved in the research. The IBC shall ensure that the PI is provided with the results of the review and status of approval in a written letter and timely manner.

d. Setting required containment levels for research projects. The IBC will set the BSL based upon criteria recommended by the CDC and NIH as the standards of containment to be applied to the corresponding biohazardous materials. The IBC may, at its discretion, increase or reduce the BSL, depending on the circumstances presented by a specific project or biological criteria.

e. Investigating any research-related accidents or illnesses or any significant violation of policies, practices and procedures. Imposing disciplinary measures in cases where there is (are) violation(s) of established biosafety practices and procedures. Reporting findings of its investigation and actions to the appropriate SDSU officials and to the granting agencies.

f. Adopting emergency plans developed by EHS and other SDSU, local and state public health and safety departments governing accidental biohazardous materials spills and personnel contamination.

g. Determining when employees who work with biohazardous materials should be enrolled in medical surveillance. Determining which specific medical surveillance tests are appropriate for a given biohazardous materials risk. EHS shall establish and maintain a medical surveillance program for at-risk personnel.

h. Developing design specifications and criteria for containment.

i. Maintaining a diverse membership representing the community and a variety of university interests.

j. Convening four times per year or more often, as necessary.

a. Being cognizant of all applicable laws, regulations, and guidelines and maintaining copies of all such documents as well as any amendments or modifications.

b. Developing requirements and guidelines for biohazard control that are consistent with applicable federal, state and local laws and regulations.

c. Reviewing proposed research or instructional activities involving the use of biohazardous materials and preparing recommendations to the IBC. Acting within the guidelines set forth and adopted by the IBC, approving low risk activities. Forwarding all other proposals to the IBC for review.

d. Developing emergency plans for handling accidental spills and personnel contamination.

e. Investigating laboratory accidents involving biohazardous materials.

f. Developing and conducting training on biosafety issues, practices and procedures.

g. Reporting to the IBC any significant problems, violations of SDSU biosafety policy, practices or procedures and any significant research-related accidents or illnesses.

h. Implementing the decisions of the IBC and assuring compliance by the PI.

i. Conducting periodic inspections to ensure that required laboratory practices and procedures are followed.

j. Reviewing biosafety facility construction/renovation plans and specifications. Inspecting construction/renovation and authorizing initiation of biohazardous materials work following construction/ renovation. Providing advice on biosafety facility design, ventilation needs and other support services. Advising on the selection, installation, maintenance and use of laboratory equipment that provides or aids in containment of biohazardous materials.

k. Coordinating the SDSU Medical Waste Management Program as described in this manual.

l. Providing proper “Biohazard” signs and labels.

a. Developing specific protocols to ensure the safe use of biohazardous materials by following instructions set forth in this manual and ensuring that all laboratory personnel comply with the specific safety protocols.

b. Making initial determination of the required levels of physical and biological containment, as well as appropriate microbiological practices and laboratory techniques.

c. Ensuring that the containment equipment and facility requirements for activities performed under his/her direction meet the criteria for the appropriate BSL and certification standard.

d. Ensuring that all maintenance work in, on or around contaminated equipment is conducted only after that equipment is thoroughly decontaminated by the laboratory staff.

e. Developing specific protocols that outline proper emergency procedures for response to an accidental exposure of personnel or the environment to the biological agents and ensuring that all laboratory staff comply with the emergency procedures.

f. Submitting a BUA application and obtaining approval from the IBC prior to commencement of work. In addition, the PI is responsible for submitting any significant changes to the BUA application to the IBC for review and approval.

g. Obtaining approval from the different committees relevant to the project. For example, obtaining approval from the Institutional Animal Care and Use Committee (IACUC) if the project involves animals; the Institutional Review Board (IRB) if the project involves human subjects; the Radiation Safety Committee (RSC) if the project involves radioisotopes.

h. Complying with the specific safety protocols and the safe practices and procedures described in this manual as well as all applicable federal, state and local laws and regulations.

i. Ensuring that all laboratory staff under his/her supervision are appropriately trained on the safe use of biohazardous materials and enrolled in medical surveillance, if appropriate. Training and medical surveillance include animal care personnel not directly supervised by the PI who provide husbandry and care for infected animals.

j. Complying with medical waste laws in handling medical waste in the laboratory and maintaining a designated medical waste autoclave or an approved medical waste accumulation area.

k. Ensuring that all laboratory staff, maintenance personnel and visitors who may be exposed to any biohazard are informed in advance of their potential risk and of the behavior required to minimize that risk. In addition, the PI is responsible for restricting access as required by the assigned biosafety containment level.

l. Reporting any significant problems, violations of the policies, practices and procedures set forth in this manual, or any significant research-related accidents and/or laboratory-acquired infection to the BSO within 24 hours.

m. Complying with shipping requirements for biohazardous materials.

These responsibilities extend to all aspects of biosafety including all individuals who enter or work in the PIs laboratory or collaborate in carrying out the PIs research. Although the PI may choose to delegate aspects of the biosafety program in his or her laboratory to other laboratory staff, the PI is ultimately responsible for all activities occurring in his or her laboratory.

a. Rigorously and conscientiously following laboratory-specific biosafety practices and procedures.

b. Reporting to the PI or the laboratory manager all problems, spills or violations in procedure immediately. Reporting to the BSO any significant violations in biosafety policy, practices or procedures that are not resolved by the PI within a reasonable amount of time.

c. Knowing all emergency procedures established by the PI.