Institutional
Biological & Chemical Safety Committee (IBC)
NIH Guidelines Summary
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm
(Click the section number to link to the full text of that section)
SECTION
III-A: Experiments Requiring IBC Registration and Approval
plus RAC Review and NIH Director Approval Before Initiation.
III-A-1-A Deliberate transfer of a drug resistance trait to microorganisms
that are not known to acquire the trait naturally, if such acquisition
could compromise the use of the drug to control the disease agents
in humans, veterinary medicine or agriculture.
SECTION
III-B: Experiments Requiring IBC Registration plus NIH/ORDA
Approval Before Initiation.
III-B-1 Cloning
of Toxin Molecules with LD50 < 100ng/kg of body
weight.
SECTION
III-C: Experiments Requiring IBC Registration plus IRB Approval
and NIH/ORDA Registration
III-C-1 Transfer of rDNA or DNA or RNA derived from rDNA into human
subjects.
SECTION
III-D: Experiments Requiring IBC Registration and approval
Before Initiation
III-D-1a Introduction of rDNA into Risk Group 2 agents, BSL-2 or ABSL-2N.
(See appendix B for listing)
III-D-1-b Introduction of rDNA into Risk Group 3 agents, BSL-3 or
ABSL-3N.
III-D-1-c Introduction of rDNA into Risk Group 4 agents,
BSL-4 or ABSL-4N.
III-D-1-d Introduction of rDNA into restricted agents requires case-by-base
review by NIH/OBA and USDA permit.
III-D-2-a DNA from Risk Group 2 or 3 agents transferred into nonpathogenic
prokaryotes or lower eukaryotes is carried out at BSL2.
III-D-2-b DNA from Risk Group 4 and restricted agents transferred
into nonpathogenic prokaryotes or lower eukaryotes is reviewed by NIH/ORDA
and requires an USDA permit.
III-D-3-a Infectious or defective [defective eukaryotic viruses contain
less than 2/3 of the genome] Risk Group 2 viruses in the presence of
helper or packaging system in tissue culture handled at BSL2 or higher
at WUSTL IBC discretion.
III-D-3-b Infectious or defective Risk Group 3 viruses and prions
in the presence of helper or packaging system in tissue culture handled
at BSL3.
III-D-3-d Infectious or defective restricted pox viruses in the presence
of helper functions in tissue culture reviewed on case-by-case basis
by NIH/ORDA and requires USDA permit.
III-D-3-e Infectious or defective viruses in the presence of helper
virus in tissue culture not covered in III-D above. IBC reserves the
right to determine Risk Group Classification for novel agents.
III-D-4-a Recombinant DNA or DNA or RNA molecules derived from rDNA
(including the creation and use of transgenic animals) except greater
than two-thirds of eukaryotic viral genome transferred to any non-human
vertebrate or an invertebrate organism. Animals with sequences from
viral vectors which do not lead to transmissible infection either directly
or indirectly are handled at BSL-1 or BSL-1N or as appropriate to the
animal. Introduction of other sequences from eukaryotic viral genomes
are covered in Section III-D-4-b. rDNA modified Risk Group 2 and higher
agents in animals are covered in Section V-A, V-G and V-L. Animal and
plant pathogens require a USDA permit.
III-D-4-b Recombinant DNA, or DNA or RNA molecules derived from rDNA
involving whole animals, not covered in Section III-D-1, human or animal
pathogen Risk Group 2 and higher as host vector systems, or Section
III-D-4-a. Containment determined by IBC.
III-D-5-a Recombinant techniques with exotic infectious agents with
recognized potential for serious detrimental impact on ecosystems using
whole plants. BSL-3P or BSL-2P+
III-D-5-b Plants with cloned genomes of readily transmissible exotic
infectious agents that may reconstitute by genomic complementation.
BSL-3P or BSL2P+
III-D-5-c Readily transmissible exotic infectious agents such as the
soybean rust fungus, maize streak or other viruses in the presence
of specific arthropod vectors. BSL-4P
III-D-5-d Sequences coding vertebrate toxins (not covered by Section
III-B-1) introduced into plants or associated organisms, BSL-3P
III-D-5-e Microbial pathogens of insects or small animals associated
with plants if the rDNA microorganism has a recognized detrimental
impact on ecosystems. BSL-3P
III-D-6 Experiments involving more than 10 liters of culture. IBC
determines containment level. (See Appendix K)
SECTION
III-E: Experiments Requiring IBC Registration Before Initiation
III-E-1 Formation of rDNA molecules containing nor more than two-thirds
of the genome of any eukaryotic virus in tissue culture, BSL-1 with
no helper virus. The WUSTL IBC classifies retroviral vectors with packaging
system capable of infecting human cells as BSL-2.
III-E-2-a rDNA modified whole plants or rDNA modified organisms not
in Section III-E-2-b. BSL-1P
III-E-2-b Plants modified by rDNA that are noxious weeds or can interbreed
with noxious weeds. Plants with rDNA that is the complete genome of
a non-exotic infectious agent. Plants associated with rDNA-modified
non-exotic microorganisms with a recognized potential for serious impact
on ecosystems or exotic microorganisms with no recognized potential
for serious impact on ecosystems. rDNA-modified arthropods or small
animals associated with plants or with arthropods or small animals
associated with them if the rDNA modified microorganisms have no serious
impact on ecosystems. BSL-2P
III-E-3 Generation
of rodents with stable introduction of DNA into the animal’s
genome if not covered in Section III-D-4. BSL-1.
SECTION
III-F: Exempt experiments Requiring IBC Registration before
Initiation (BSL-1)
III-F-1 Not in organisms or viruses.
III-F-2 DNA segments from a single non-chromosomal or viral DNA source.
III-F-3 DNA from prokaryotic host when propagated only in that host
or transferred to another host by well established physiological means.
III-F-4 DNA from an eukaryotic host when propagated only in that host
(or closely related host). See Appendices A-I through A-VI for a list
of natural exchangers.
III-F-5 DNA segments from different species that exchange DNA by known
physiological processes.
III-F-6 Those that do not present a significant risk to health or
the environment.
Appendix
C-1 Recombinant DNA (non-virus vector) in Tissue Culture
(see C-IV for exceptions)
Appendix
C-II E. coli K-12 host-vector systems. (See C-II-A for exceptions)
Appendix
C-III Saccharomyces host-vector systems. (See C-III-A for
exceptions)
Appendix
C-VI Purchase or transfer of transgenic rodents.
Please contact OBCS (747-0309) if you need assistance assessing which
Guidelines sections apply to your experiments.
