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VI-17.00(A) UNIVERSITY OF MARYLAND POLICY ON BIOSAFETY
Approved by the President July 31, 1997
I. PURPOSE
This is a statement of official University of Maryland policy to
establish the process for compliance with the following
documents:
A. NIH Guidelines for Research Involving Recombinant DNA
Molecules (NIH Guidelines), current edition;
B. Biosafety in Microbiological and Biomedical
Laboratories (BMBL), current edition.
II. POLICY
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.
III. RESPONSIBILITIES
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
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.
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
required:
(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
campus.
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
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.
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.
IV. INFORMATION
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.
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