UNIVERSITY OF TOLEDO
INSTITUTIONAL BIOSAFETY COMMITTEE
research.utoledo.edu
RSP600 (05/07)
Instructions and Information for Completing and Submitting
An Application for Research Employing Recombinant DNA,
Infectious Agents, and/or Biohazardous Materials
There has been a restructuring of review and oversight responsibilities for hazardous chemical and biological materials.
The Institutional Animal Care and Use Committee (IACUC) will review and approve the use of hazardous chemical
agents being administered to live animals via Form RGA402. The Institutional Biosafety Committee (IBC) will review
and approve the use of biological hazards (bacteria, viruses, tumor cells, etc) in addition to approving research involving
recombinant DNA molecules and Select Agents/Toxins.
The application form has been revised to reflect this change. It is divided into parts, each one a separate document, and
only the parts applicable to your proposed research need to be completed and submitted.
1. Please submit a typewritten original and 15 copies of all the pertinent Parts to Research and Sponsored
Programs:
a) RSP600: Instructions and Information - This is for investigators’ use and need not be submitted.
b) RSP601: Part 1 - General Information - REQUIRED for all applications
c) RSP602: Part 2 - Research involving Recombinant DNA Molecules
d) RSP603: Part 3 - Research involving Biohazardous Agents/Materials
e) RSP604: Part 4 - Research involving Introduction of Recombinant DNA Molecules and/or Biohazardous
Agents/Materials into Live Animals - Please contact Dr. Brent Martin for review of this
section prior to submitting the application to the IBC.
f) RSP605: Amendments – Once the protocol is approved any revisions must be submitted using this form.
2.
Applications may be submitted to to the RSP Office at any time.
3.
The following resources provide useful information for completing parts of the application.
The "Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) April 2002," initially effective
June 24, 1994, published in the Federal Register (July 5, 1994, 59 FR 34496), as amended and the CDC/NIH “Biosafety
in Microbiological and Biomedical Laboratories (BMBL) 5th Edition” are available through links on the RSP website
under “Biosafety,” “Use of Recombinant DNA in Research.”
Select agents or toxins are agents that HHS considers to have the potential to pose a severe threat to human health. A list
of these agents are found in the select agents regulation (42 CFR 73) or http://www.selectagents.gov/agentToxinList.htm.
All select agents must be registered with the Biosafety Officer and the IBC committee prior to receipt of the select
agent/toxin in any quantity.
RISK ASSESSMENT (based on NIH Guidelines, Section II-A and Appendix B)
Classification of agents in Appendix B is based on the potential effect of a biological agent on a healthy human adult and
does not account for instances in which an individual may have increased susceptibility to such agents, e.g., preexisting
diseases, medications, compromised immunity, pregnancy or breast feeding (which may increase exposure of infants to
some agents).
PHYSICAL CONTAINMENT (based on NIH Guidelines, Section II-B and Appendix G-II)
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Factors to be considered in determining the level of containment include agent factors such as: virulence, pathogenicity,
infectious dose, environmental stability, route of spread, communicability, operations, quantity, availability of vaccine or
treatment, and gene product effects such as toxicity, physiological activity, and allergenicity. Any strain that is known to
be more hazardous than the parent (wild-type) strain should be considered for handling at a higher containment level.
The containment level required may be equivalent to the Risk Group classification of the agent or it may be raised or
lowered as a result of the above considerations.
BIOSAFETY LEVEL CRITERIA (from CDC/NIH BMBL, 5th edition, Section III)
http://www.cdc.gov/od/ohs/biosfty//bmbl5toc.htm
Biosafety Level 1 (BSL-1): Suitable for work involving well-characterized agents not known to consistently cause
disease in immunocompetent adult humans, and present minimal potential hazard to
laboratory personnel and the environment. BSL-1 laboratories are not necessarily separated
from the general traffic patterns in the building. Work is typically conducted on open bench
tops using standard microbiological practices.
Special containment equipment or facility design is not required, but may be used as
determined by appropriate risk assessment. Laboratory personnel must have specific training
in the procedures conducted in the laboratory and must be supervised by a scientist with
training in microbiology or a related science
Biosafety Level 2 (BSL-2): Builds upon BSL-1. BSL-2 is suitable for work involving agents that pose moderate hazards
to personnel and the environment. It differs from BSL- 1 in that 1) laboratory personnel have
specific training in handling pathogenic agents and are supervised by scientists competent in
handling infectious agents and associated procedures; 2) access to the laboratory is restricted
when work is being conducted; and 3) all procedures in which infectious aerosols or splashes
may be created are conducted in BSCs or other physical containment equipment.
Biosafety Level 3 (BSL-3): is applicable to clinical, diagnostic, teaching, research, or production facilities where work is
performed with indigenous or exotic agents that may cause serious or potentially lethal
disease through inhalation route exposure. Laboratory personnel must receive specific
training in handling pathogenic and potentially lethal agents, and must be supervised by
scientists competent in handling infectious agents and associated procedures. All procedures
involving the manipulation of infectious materials must be conducted within BSCs, other
physical containment devices, or by personnel wearing appropriate personal protective
equipment. A BSL-3 laboratory has special engineering and design features.
ANIMAL BIOSAFETY LEVEL CRITERIA (Section IV)
Animal Biosafety Level 1 (ABSL-1): is suitable for work involving well characterized agents that are not known to
cause disease in immunocompetent adult humans, and present minimal potential
hazard to personnel and the environment.
Animal Biosafety Level 2 (ABSL-2):
builds upon the practices, procedures, containment equipment, and facility
requirements of ABSL-1. ABSL-2 is suitable for work involving laboratory
animals infected with agents associated with human disease and pose moderate
hazards to personnel and the environment. It also addresses hazards from
ingestion as well as from percutaneous and mucous membrane exposure.
Animal Biosafety Level 3 (ABSL-3):
involves practices suitable for work with laboratory animals infected with
indigenous or exotic agents, agents that present a potential for aerosol
transmission and agents causing serious or potentially lethal disease. ABSL-3
builds upon the standard practices, procedures, containment equipment, and
facility requirements of ABSL-2. ABSL-3 laboratory has special engineering and
design features.