Biomedical Engineering Reference
In-Depth Information
reference. In the first instance, NIH classifies the hazard into the following
four categories.
Risk Group 1 (RG1)
Agents that are not associated with disease in healthy adult humans
Risk Group 2 (RG2)
Agents that are associated with human disease that is rarely serious
and for which preventive or therapeutic interventions are
often
available
Risk Group 3 (RG3)
Agents that are associated with serious or lethal human disease for
which preventive or therapeutic interventions
may be
available (high
individual risk but low community risk)
Risk Group 4 (RG4)
Agents that are likely to cause serious or lethal human disease for
which preventive or therapeutic interventions are
not usually
available (high individual risk and high community risk)
Most of the GMOs that are used would fall in Risk Group 1 or 2. There is
also an exempt group that is provided in Appendix C of the NIH Guidelines.
Appendix C-VIII-E i.e., the total of all genomes within a Family shall
not exceed one-half of the genome.
Appendix C-I (
Recombinant DNA in Tissue Culture
) states:
Recombinant
DNA molecules containing less than one-half of any eukaryotic viral
genome (all viruses from a single family being considered identical—
see Appendix C-VIII-E,
Footnotes and References of Appendix C
), that are
propagated and maintained in cells in tissue culture are exempt from
these
NIH Guidelines
with the exceptions listed in Appendix C-I-A.
Appendix C-I-A. Exceptions
The following categories are not exempt from the NIH Guidelines: (i)
experiments described in Section III-A which require Institutional
Biosafety Committee approval, RAC review, and NIH Director
approval before initiation, (ii) experiments described in Section III-B
which require NIH/OBA and Institutional Biosafety Committee
approval before initiation, (iii) experiments involving DNA from Risk
Groups 3, 4, or restricted organisms (see Appendix B, Classification
of Human Etiologic Agents on the Basis of Hazard, and Sections
V-G and V-L,
Footnotes and References of Sections I through IV
) or cells
known to be infected with these agents, (iv) experiments involving
the deliberate introduction of genes coding for the biosynthesis of
molecules that are toxic for vertebrates (see Appendix F,
Containment
Conditions for Cloning of Genes Coding for the Biosynthesis of Molecules
Toxic for Vertebrates
), and (v) whole plants regenerated from plant
cells and tissue cultures are covered by the exemption provided they
remain axenic cultures even though they differentiate into embry-
onic tissue and regenerate into plantlets.
