Institutional Biosafety at SIU | Center for Environmental Health and Safety | SIU

Definitions

Acceptable Standards: Those standards stated or implied in the most recent versions of the National Institutes of Health (NIH) "Guidelines for Research Involving Recombinant DNA Molecules", the NIH "Laboratory Safety Monograph", and the US Dept. of Health and Human Services "Biosafety in Microbiological and Biomedical Laboratories". The minimum standards contained in the above guides shall apply unless the IBC establishes a more stringent requirement to better serve needs unique to SIUC facilities and personnel.

Biological Materials: These shall include living organisms, products produced by such organisms, organic chemicals produced to mimic activity/actions of such products, and recombinant DNA molecules.

Hazardous Materials: Any biological materials which present a risk to the well-being of humans, animals, or plants either directly or indirectly.

Incident: Any situation involving a hazardous agent(s) that results in potential imminent danger to the public health or welfare.

Duties and Powers of the IBC

1. The IBC shall be comprised of at least ten faculty/staff members representing various areas of expertise (e.g., microbiology, chemistry and biochemistry, zoology, plant biology, veterinary medicine, medicine) appropriate to the duties and responsibilities of the IBC, two members from the community at large, and the BSO.

2. Members of the IBC and its chair shall be appointed by and report to the Vice Chancellor for Academic Affairs and Provost, or the designee of that office. Except for the BSO, terms of appointment shall be staggered and last for three years. Thus, three or four new members will be added to the IBC in any given year.

3. The IBC shall have three principal functions: 

   a. Dean of the Graduate School, and Graduate Council on the development and implementation of policies for the safe conduct of research involving potentially hazardous biological materials and any research involving recombinant DNA. The Graduate Council will then be responsible for approving such policies.

   b. Review, approve and oversee all projects involving potentially hazardous biological materials or recombinant DNA through review of each researcher's Memorandum of Understanding and Agreement (MUA).

   c. If proposed projects or activities involving potentially hazardous biological materials or recombinant DNA are not approved by the IBC, all activities shall immediately cease pending appeal. The researcher(s), BSO, and the Vice Chancellor for Academic Affairs and Provost will be advised of such action by the IBC Chair. 

Duties and Powers of the BSO

1. The BSO shall be appointed by the Vice Chancellor for Academic Affairs and Provost and shall function as a primary agent of the IBC in the daily and routine administration of the biological safety program. Specifically, the BSO shall monitor and enforce compliance with the safety guidelines established by the IBC. As a voting member of the IBC, the BSO shall report to the IBC Chair as well as to the Vice Chancellor for Academic Affairs And Provost.

2. The BSO shall have responsibility for making periodic, unannounced inspections of all facilities using biological materials considered hazardous under existing University standards. The BSO shall also have the responsibility to inspect and regulate facilities not currently registered with the IBC if sufficient cause for such action is deemed warranted by the BSO and/or the IBC.

3. Any actions taken by or recommendations made by the BSO shall be fully complied with pending review by the IBC.

IBC and BSO Procedures for Acting On and Reporting Violations

In the event of failure to observe safety regulations and rules on the part of any University personnel, the BSO shall:

1. Inform the IBC Chair if such deficiencies are not corrected promptly.

2. If necessary, the BSO has authority to order immediate shutdown or cessation of work in any facility where it is evident that health hazards exist to the extent that continued operation would result in violation of University-adopted biosafety standards.

The Chairperson of the IBC shall report the violation to the IBC at its next regular meeting, or call a special meeting to review the violation if urgency makes it necessary. The IBC, after consideration, may:

1. Recommend mandatory remedial action to the Vice Chancellor for Academic Affairs And Provost. Failure to comply may result in withdrawal of IBC approval of the existing project/activities.

2. Withdraw or rescind approval of the project. In the event the IBC takes such action, the project may no longer be conducted at the University until such time as corrections are made to qualify the project for reinstatement.

Appeal Procedure

Any restraining order, decision, or application disapproval by the IBC or the BSO may be appealed directly to the IBC. The staff member(s) involved in such consideration may be present at the IBC meeting and may present facts pertinent to the deliberations. A simple majority vote of the IBC is needed to uphold or reverse decisions made by the BSO or IBC.

IBC decisions may be appealed to the Vice Chancellor for Academic Affairs and Provost. Appeals must be submitted in writing with necessary supporting documentation to the IBC Chair who shall forward the appeal to the Vice Chancellor for Academic Affairs and Provost.

Actions/decisions by the BSO/IBC must be adhered to pending final action on the appeal.

Reporting Incidents

It shall be mandatory for University personnel involved in or knowledgeable about incidents to immediately report such to the BSO. In the event the BSO is unavailable, the incident shall be reported to the IBC Chair. In the absence of the IBC Chair, the incident shall be reported to a faculty member of the IBC (list of current members available in the Office of the Dean of the Graduate School). All persons listed above shall have the authority to evacuate and close down rooms, buildings, or any affected areas if an incident warrants such action.

The affected areas shall remain closed until the BSO is available to direct cleanup and/or decontamination procedures. The BSO and the IBC will determine when and under what conditions a research facility may be reopened following an incident. Written notification to that effect will be sent to the principle investigator/facility supervisor and copied to the Vice Chancellor for Academic Affairs and Provost.

Procedures for Submitting MUAs

1. The principle investigator shall be responsible to submit an MUA (see appendix) to the BSO who will forward it to the IBC for review.

2. The methods section must provide enough detail for the IBC to evaluate biological hazard risk and judge if adequate safeguards are incorporated in the experimental design. Properties of the biological material(s) used must be fully described. If a Material Safety Data Sheet (MSDS) is available for the substance, a copy must be attached to the MUA.

3. All personnel involved in the experimental work must receive training regarding biological safety practices and procedures. The principal investigator is responsible for ensuring that this training is conducted and for providing the BSO with training verification.

4. An approved MUA is valid for a period of three years. Researchers wishing to continue work under an old MUA must notify the BSO who will forward it to the IBC for review.

Classification of Human Etiologic Agents on the Basis of Hazard

This appendix includes those biological agents known to infect humans as well as selected animal agents that may pose theoretical risks if inoculated into humans. Included are lists representative general and species known to be pathogenic; mutated, recombined, and non-pathogenic species and strains are not considered. Noninfectious life cycle stages of parasites are excluded.

This appendix reflects the current state of knowledge and should be considered a resource document. Included are the more commonly encountered agents and is not meant to be all inclusive. Information on agent risk assessment may be found in the Agent Summary Statements of the CDC/NIH publication, Biosafety in Microbiological and Biomedical Laboratories (see Sections V-C, VD, VE and VF, Footnotes and References of Sections I through I\/. Further guidance on agents not listed in Appendix B may be obtained through: Centers for Disease Control and Prevention, Biosafety Branch, Atlanta, Georgia 30333, Phone: (404) 639-3883, Fax: (404) 6392294; National Institutes of Health, Division of Safety, Bethesda, Maryland 20892, Phone: (301) 496-1357; National Animal Disease Center, U.S. Department of Agriculture, Ames, lowa 50010, Phone: (515) 862-8258.

A special committee of the American Society for Microbiology will conduct an annual review of this appendix and its recommendation for changes will be presented to the Recombinant DNA Advisory Committee as proposed amendments to the NIH Guidelines.