Environmental Health and Safety: Institutional Biosafety

University of Rhode Island

Institutional Biosafety

IBC Meeting Schedule

FORMS

Biosafety Infectious Agent Protocol Review Form;

Biosafety Recombinant DNA Protocol Review Form

Select Agent Registration

The University of Rhode Island Institutional Biosafety Committee (IBC) reviews and approves research protocols involving biological materials to ensure that investigators adequately address safety issues and regulatory compliance. The IBC also oversees proposals involving any aspect of rDNA (recombinant DNA) technology. The Biosafety Committee is charged with determining that a Principal Investigator (PI) who administers, handles or uses biohazardous/carcinogenic materials, uses these materials safely. This includes the demonstration of an occupational safety and health program (for the agent used) to protect workers as well as implementation of safeguards to protect the environment. The Committee also determines that the facilities in which the work is being undertaken are appropriate and fulfill federal guidelines. The IBC works in conjunction with the University Animal Care Committee and the Office of Safety and Risk management.

Biohazards are biological agents or substances present in or arising from the work environment. They present or may present a hazard to the health or well-being of the worker or the community. Biological agents and substances include infectious and parasitic agents, noninfectious microorganisms, such as some fungi, yeast, algae, plants and plant products, and animals and animal products that cause occupational disease. Generally, biohazards are either:

                                1. Infectious microorganisms
                                2. Toxic biological substances
                                3. Biological allergens, or
                                4. Any combination of the above

Important information regarding the classification and handling of biohazardous materials can be found at the CDC website:
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm

Institutional Biosafety Committees (IBCs) and the NIH Office of Biotechnology Activities (OBA) are partners in promoting the safe conduct of recombinant DNA research through compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). An IBC provides local oversight in assessing the appropriate containment for recombinant DNA research; reviewing the adequacy of facilities, procedures, practices and investigator training; and ensuring adherence to Appendix M of the NIH Guidelines, which outlines the requirements associated with human gene transfer protocols. You may review these responsibilities by accessing the NIH Guidelines on-line at: http://www4.od.nih.gov/oba.html

It is the responsibility of a Principal Investigator to submit a Biosafety Infectious Agent Protocol Review Form , a Biosafety Recombinant DNA Protocol Review Form to the Research Office, Division of Compliance, 70 Lower College Road, before commencing with the use of any biohazardous/pathogenic material or Recombinant DNA. The Chair of the IBC or a designated committee member will complete a preliminary review of the proposal to determine if there is a need for full committee review. An Action Report will be issued to the PI following initial review.

In response to the growing concern about the possible use of biological, chemical, and radioactive materials as agents for terrorism, guidelines were developed by the CDC which address laboratory security issues (e.g., preventing unauthorized entry to laboratory areas and preventing unauthorized removal of dangerous biological agents from the laboratory). These guidelines should be reviewed by all individuals using biological agents or toxins capable of causing serious or fatal illness to humans or animals. www.cdc.gov/od/ohs/biosfty/bmbl4/b4af.htm

University of Rhode Island Select Agent Policy and Procedures

National concerns in regarding the security and possession of select agents prompted the passage of the Public Health Security and Bio-terrorism Preparedness and Response Act of 2002, signed into law on 12 June 2002. Regulations implementing this act became effective on February 7, 2003. The regulations include many new provisions such as:
1. a revised list of select agents;
2. submission of the names of individuals with access to select agents to the Department of Justice for background checks;
3. development of bio-security and bio-safety plans for entities wanting to use select agents for research;
significant record keeping (including inventories and those accessing select agents) and training.
4. registration with the Centers for Disease Control and Prevention to possess the select agents;
5. significant record keeping (including inventories and those accessing select agents) and training.

CDC Select Agent Program: Includes links to Select Agent regulations (42 CFR 73) as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107-188, and the USA Patriot Act, Public Law 107-56.

LINKS

For more information:
Professor Joel Chandlee
Chair, IBC
874-2529
joel_chandlee@uri.edu

Doreen Lawson
Director of Compliance
Research Office
874-4328
dlawson@uri.edu