University of Maryland Policy on Biosafety

This is a statement of official University of Maryland policy to establish the process for compliance with the following documents:

1. NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), current edition;
2. Biosafety in Microbiological and Biomedical Laboratories (BMBL), current edition.

The University of Maryland is actively committed to preserving the health and safety of its students, staff, and faculty, and to protecting the environment and the community. It is recognized that use of potentially pathogenic microorganisms and organisms containing recombinant DNA (rDNA) is necessary in many university research and teaching laboratories. To ensure the safe handling of these organisms, the university requires compliance with the NIH Guidelines and with the recommendations in BMBL. Compliance with other applicable federal, state, and local regulations is also required.

The Principal Investigator (PI) is directly and primarily responsible for the safe operation of the laboratory. His/her knowledge and judgment are critical in assessing risks and appropriately applying the recommendations in this manual. However, safety is a shared responsibility among all of the laboratory staff. Many resources exist to assist the PI with these responsibilities, including the Biological and Chemical Hygiene Committee (BACH), the Institutional Biosafety Committee (IBC), and the Department of Environmental Safety (DES).

1. The Department of Environmental Safety (DES) shall:
   1. Prepare the Biosafety Manual, with revisions as necessary;
   2. Distribute the Manual to each faculty member who works with biological materials;
   3. Investigate accidents involving infectious agents;
   4. Collect and dispose of Biological, Pathological and Medical Waste;
   5. Provide or coordinate biosafety training as requested;
   6. Assist investigators with risk assessment; and
   7. Administer all elements of the Biosafety Program, assist faculty with submission of registrations to the IBC, and maintain registration files.
2. Principal Investigators (PI) shall:
   1. Assess the risks of their experiments;
   2. Ensure the safe operation of their laboratory;
   3. Train laboratory personnel in safe work practices;
   4. Comply with all applicable state and federal regulations and guidelines;
   5. Register the following experiments with the Institutional Biosafety Committee (IBC) or the Department of Environmental Safety (DES), as required:
      1. recombinant DNA activities;
      2. work with infectious agents; and
      3. experiments involving the use of human blood or other potentially infectious materials, such as unfixed human tissues, primary human cell lines, and certain body fluids.
3. The Biological and Chemical Hygiene Committee (BACH) shall work cooperatively with researchers, faculty, and staff to promote biological and chemical safety on the campus.
4. The Institutional Biosafety Committee (IBC) shall:
   1. Review rDNA research conducted at or sponsored by the university for compliance with the NIH Guidelines, and approve those research projects that are found to conform with the NIH Guidelines;
   2. Review research involving infectious agents conducted at or sponsored by the university for compliance with the guidelines in Biosafety in Microbiological and Biomedical Laboratories (BMBL), and approve those research projects that are found to conform with the recommendations in BMBL;
   3. Notify the PI of the results of the IBC's review and approval;
   4. Report any significant problems with or violations of the NIH Guidelines and any significant research-related accidents or illness to the appropriate Institutional official and to the NIH Office of Recombinant DNA Activities (ORDA) within 30 days; and
   5. Follow the guidelines for membership defined by NIH, with the additional requirement of one representative from the University of Maryland Animal Care and Use Committee, and a plant pathologist from USDA as appropriate.
5. The University Health Center (UHC) shall:
   1. Provide medical surveillance, as required by the OSHA Bloodborne Pathogens Standard (CFR 1910.1030), and as recommended in the BMBL and NIH Guidelines; and
   2. Provide vaccinations, as required.
6. Laboratory personnel shall:
   1. Comply with safety recommendations for the work being performed; and
   2. Report accidents or injuries to the PI.

DES will assist any Department in providing training and guidance for implementation of this policy. Registration forms and the publications referenced in Section I above are available through the Department of Environmental Safety web page at http://www.inform.umd.edu/DES/biosafety.html.