Recombinant DNA Categories

RCS

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NIH Guideline Reference Categories pdf

Section III-A IBC Approval, RAC Review & NIH Director Approval before Initiation of research

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 disease agents in humans, veterinary medicine, or agriculture.

Transfer of a drug resistance to microorganisms compromising the use in veterinary medicine set by NIH.

Section III-B NIH/OBA & IBC Approval before Initiation of research

III-B-1

Cloning of toxin molecules with LD50 of less than 100 ηg/kg body weight

Section III-C IBC & IRB Approval & RAC Review before research participant enrollment

III-C-1

Deliberate transfer of R-DNA or DNA or RNA derived from R-DNA into human research participants.

No research participant shall be enrolled until RAC review has been completed.

RAC holds a public review and discussion

Section III-D IBC Approval before initiation of research

III-D-1-a

Using Risk Group 2 agents as host-vector systems at BSL-2 or BSL-2-N.

Experiments with RG2 R-DNA modified microbes in any animal at BSL-2.

III-D-1-b

Using Risk Group 3 agents as host-vector systems at BSL-3 or BSL-3-N.

Experiments with RG3 R-DNA modified microbes in any animal at BSL-3.

III-D-1-c

Using risk Group 4 agents as host-vector systems at BSL-4 or BSL-4-N.

Experiments with RG4 R-DNA modified microbes in any animal at BSL-4.

III-D-1-d

Using restricted agents as host-vector systems at BSL-4 or BSL-4-N.

Experiments with R-DNA modified restricted agent in an animal at BSL-4 or BSL-4-N.

Experiments with R-DNA modified animal pathogens in an animal at BSL-4 or BSL-4-N.

III-D-2-a

DNA from Risk Group 2, 3, 4 or restricted agents cloned into nonpathogenic prokaryotes or lower eukaryotes host-vector systems

III-D-2-b

DNA from restricted agents is transferred into nonpathogenic prokaryotes or lower eukaryotes biosafety level determined by NIH/OBA review.

III-D-3-a

Transfer using infectious or defective Risk Group 2 viruses or defective viruses using helper virus in tissue culture systems at BSL-2

III-D-3-b

Transfer using infectious or defective Risk Group 3 viruses or defective viruses using helper virus in tissue culture systems at BSL-3

III-D-3-c

Transfer using infectious or defective Risk Group 4 viruses or defective viruses using helper virus in tissue culture systems at BSL-4

III-D-3-d

Transfer using infectious or defective poxviruses using helper virus in tissue culture systems biosafety level determined by NIH/OBA review

III-D-3-e

Transfer using infectious or defective viruses using helper virus not covered in Sections III-D-3-a through III-D-3-d are conducted at BSL-1

III-D-4-a

R-DNA or DNA or RNA from any source, other than greater than ⅔ of eukaryotic viral genome, transferred into germ line of any non-human vertebrate other than rodents or any invertebrate organism (arthropods) at BSL-1.

Introduction of other sequences from eukaryotic viral genomes into animals are covered under Section III-D-4-b.

Experiments with transgenic rodents: The purchase or transfer of transgenic rodents requiring BSL-1 containment is exempt under Appendix C-6. Subsequent use of these animals is also exempt providing the experimental protocol does not involve the use of R-DNA. If the protocol does involve use of R-DNA then the research is covered under IIID-4-a.

Experiments with transgenic animals other than rodents at BSL-1.

Experiments with R-DNA modified arthropods not associated with plants at BSL-1.

Introduction of less than 2/3 of eukaryotic viral genome into a non-human vertebrate or invertebrate at BSL-1 or BSL-1-N.

Propagation of animals containing viral vector sequences not leading to transmissible infection at BSL-1 or BSL-1-N.

Purchase or transfer of transgenic rodents or transgenic animals other than rodents at BSL-1.

III-D-4-b

R-DNA or DNA or RNA involving whole animals, including transgenic animals, not covered by Sections III-D-1 or III-D-4-a. BSL set by IBC.

Experiments involving the generation of transgenic rodents or knock-out rodents or non-rodents or arthropods requiring BSL-2, BSL-3 and BSL-4 containment.

Breeding rodents from one strain (propagation/colony maintenance) at BSL-2 or higher.

Breeding rodents from two strains (generating new strain) at BSL-2 or higher.

Breeding recombinant arthropods at BSL-2 or higher.

Breeding knockouts (propagation) at BSL-2 or higher.

Breeding knockouts from two strains (generating new strain) at BSL-2 or higher.

Experiments with transgenic rodents ≥ BSL-2 set by IBC.

Experiments with transgenic animals other than rodents ≥BSL-2 set by IBC.

Experiments with R-DNA modified arthropods not associated with plants at BSL-2 or higher.

Purchase or transfer of transgenic rodents or transgenic animals other than rodents at BSL-2 or higher.

Purchase or transfer of R-DNA modified arthropods at BSL-2 or higher.

III-D-4-c(1)

Generation of transgenic rodents at BSL-1-N containment described in III-E-3 -experiments involving transgenic rodents

III-D-4-c(2)

Purchase or transfer of transgenic rodents is exempt from the Guidelines (III-F4)

III-D-5-a

BSL-3-P or BSL-2-P+ biological containment for experiments involving most exotic infectious agents with recognized potential for serious detrimental impact on managed or natural ecosystems.

Experiments with microorganisms or insects containing R-DNA with potential for detrimental impact to ecosystem at BSL-3-P or BSL-2-P plus biological containment.

III-D-5-b

BSL-3-P or BSL-2-P+ biological containment for experiments involving plants containing cloned genomes of readily transmissible exotic infectious agents with recognized potential for serious detrimental impact on managed or natural ecosystems when there is possible reconstitution the infectious agent by genomic complementation in plants

III-D-5-c

BSL-4-P for experiments with small number of readily transmissible exotic infectious agents in the presence of the infectious agent's specific arthropod vector, that has the potential of being serious pathogens of major U.S. crops.

Experiments with exotic infectious agents in the presence of arthropod vectors at BSL-4-P.

III-D-5-d

BSL-3-P for experiments involving sequences encoding potent vertebrate toxins introduced into plants or associated organisms

III-D-5-e

BSL-3-P or BSL-2-P+ biological containment for experiments with microbial pathogens of insects or small animals associated with plants if the R-DNA-modified organism has a recognized potential for serious detrimental impact on managed or natural ecosystems.

Experiments with microbial pathogens of insects or small animals associated with plants with the potential for detrimental impact to ecosystems at BSL-3-P or BSL-2-P plus biological containment.

III-D-6

Containment for R-DNA involving more than 10 Liters of culture will be decided by IBC

Section III-E IBC Notice simultaneous with initiation of research

III-E-1

Formation of R-DNA containing no more than ⅔ eukaryotic virus genome propagated and maintained in cells in tissue culture at BSL-1

III-E-2

Experiments with R-DNA modified arthropods associated with plants at BSL-2 or higher.

Small animals associated with R-DNA modified plants at BSL-1.

III-E-2-a

BSL-1-P for R-DNA-containing plants and plant-associated microorganisms not covered in Section III-E-2-b

III-E-2-b(1)

Plants modified by R-DNA that are noxious weeds or can interbreed with noxious weeds in immediate geographical area

III-E-2-b(2)

Plants with R-DNA representing the complete genome of a non-exotic infectious agent

III-E-2-b(3)

Plants with R-DNA-modified non-exotic microorganisms with recognized potential for serious detrimental impact on managed or natural ecosystems

III-E-2-b(4)

Plants with R-DNA-modified non-exotic microorganisms that have no recognized potential for serious detrimental impact on managed or natural ecosystems

III-E-2-b(5)

R-DNA-modified arthropods or small animals associated with plants, or arthropods or small animals with R-DNA-modified microorganisms associated with them, when the R-DNA-modified microorganisms have no recognized potential for serious detrimental impact on managed or natural ecosystems.

Experiments with R-DNA modified arthropods or small animals associated with plants at BSL-1.

Experiments with R-DNA modified arthropods associated with plants at BSL-1.

III-E-3

Generation of rodents and knock-out rodents when genome has been altered by stable introduction of R-DNA, or genome derived DNA, into the germ-line only when the animals can be housed at BSL-1-N.

Breeding rodents from two strains (generating new strain) at BSL-1.

Breeding knockouts from two strains (generating new strain) at BSL-1.

Section III-F Exempt - IBC Notice and administrative registration

III-F-1

R-DNA not in organisms or viruses (DNA amplification)

III-F-2

R-DNA segments from a single non-chromosomal or viral DNA source

III-F-3

R-DNA from prokaryotic host, including indigenous plasmids, or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well established physiological means

III-F-4

R-DNA from eukaryotic host, including its chloroplasts, mitochondria, or plasmids (but excluding viruses), when propagated only in that host (or a closely related strain of the same species).

Breeding rodents from one strain (propagation/colony maintenance at BSL-1.

Breeding recombinant arthropods.

Breeding knockouts (propagation) at BSL-1.

III-F-5

R-DNA segments from different species that exchange DNA by known physiological processes

III-F-6

R-DNA not presenting a significant risk to health or the environment

Section IV-C-1-b

R-DNA in tissue culture, Escherichia coli K-12 host-vector systems, Saccharomyces host-vector systems, Bacillus subtilis or Bacillus licheniformis host-vector systems, Extrachromosomal elements of Gram Positive organisms

Appendix C-6

Purchase or transfer of transgenic rodents at BSL-1.