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Tip Sheet Volume 3:4
Compliance: Biohazards and
Public Health
The 1986 Federal Register required
all institutions to form a biosafety committee to oversee research
involving recombinant DNA. The responsibility of the biosafety
committee was later expanded to include all potentially hazardous
biological materials, including recombinant DNA, transgenic plants
or animals, infectious agents (human or animal), and biological
toxins such as tetanus toxin or aflatoxin. The following information
describes the activities of ISU's Biohazards and Public Health
Committee (BPHC).
Responsibilities of the Biohazards
and Public Health Committee
The BPHC reviews and sets conditions for conducting research
that involves recombinant DNA or transgenic animals; reviews
programs involving biological safety and public health protection
at ISU; and sets policies that comply with federal, state, and
local regulations and recommendations. These responsibilities
include assessing the adequacy of laboratory facilities, containment
and safety practices; the appropriate training and expertise
of project personnel; and compliance with all applicable regulations.
In addition, the University must report any significant problems,
violations, accidents, or illnesses associated with recombinant
DNA usage to the Federal Office of Biotechnology Activities.
Application and Authorization
The Application for Use of Recombinant DNA, Infectious Agents,
or Biological Toxins must be completed and submitted to the Biosafety
Officer prior to conducting research with potentially hazardous
biological materials. The Biosafety Officer will conduct the
initial review and then forward the application to the BPHC committee
members. The project will be either approved as is, approved
with special conditions that need to be met, or denied. If the
project is not approved, a written
notification will be provided that explains the decision and
identifies possible conditions or modifications to the project
that would make it acceptable.
For projects that require approval
of both the BPHC and the Committee on Animal Care (COAC), a single
application may be filed, the COAC Protocol Review Form, including
appropriate biohazardous agents section(s). The single application
is submitted to the COAC, but gets reviewed by both committees.
Separate approval authorizations are issued from each committee.
Annual Renewal
All applications authorized for approval must be renewed annually,
up to a total of five years. The principal investigator will
receive a reauthorization form 60 days before the authorization
anniversary date. After five years, a new application must be
submitted.
Reminder:
The use of animals in a research project requires additional
approval from the ISU Committee on Animal Care and the use of
human subjects in a research project requires approval from the
ISU Institutional Review Board.
Contact Information: Additional information about BPHC policies
and procedures can be found at: http://www.ehs.iastate.edu/bs/bphc.htm.
For questions, please contact Julie Johnson, Biosafety Officer,
at jajohns@iastate.edu, 294-7657.
If you have any questions
about this tip sheet or working with industry, please contact:
Lisa Lorenzen, 1210 Molecular Biology Building, Phone: (515)
294-0926, Email: llorenze@iastate.edu
Acknowledgement: Thanks to
Julie Johnson for providing the information for this tip sheet.
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