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University of Maryland Policy on Biosafety

Consolidated USM and UMD Policies and Procedures


Approved by the President July 31, 1997

  This is a statement of official University of Maryland policy to
  establish the process for compliance with the following
       A.   NIH Guidelines for Research Involving Recombinant DNA
            Molecules (NIH Guidelines), current edition;
       B.   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).
       A.   The Department of Environmental Safety (DES) shall:
            (1)  Prepare the Biosafety Manual, with revisions as
            (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
            (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.
       B.   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
                 (a)  recombinant DNA activities;
                 (b)  work with infectious agents; and
                 (c)  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.
       C.   The Biological and Chemical Hygiene Committee (BACH)
            shall work cooperatively with researchers, faculty, and
            staff to promote biological and chemical safety on the
       D.   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
            (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.
       E.   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.
       F.   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.