Environmental Concerns - Disposable Bioprocessing Systems - page 214

Appendix B: Classification of Human Etiologic
Agents on the Basis of Hazard
This appendix includes those biological agents known to infect humans as
well as selected animal agents that may pose theoretical risks if inoculated
into humans. Included are lists of representative genera and species known
to be pathogenic; mutated, recombined, and nonpathogenic species and
strains are not considered. Noninfectious life-cycle stages of parasites are
excluded.
This appendix reflects the current state of knowledge and should be con-
sidered a resource document. Included are the more commonly encoun-
tered agents and is not meant to be all-inclusive. Information on agent risk
assessment may be found in the Agent Summary Statements of the CDC/
NIH publication, Biosafety in Microbiological and Biomedical Laboratories
(see Sections V-C, V-D, V-E, and V-F, Footnotes and References of Sections
I through IV . Further guidance on agents not listed in Appendix B may be
obtained through Centers for Disease Control and Prevention, Biosafety
Branch, Atlanta, Georgia 30333, Phone: [phone], Fax: [phone];
National Institutes of Health, Division of Safety, Bethesda, Maryland 20892,
Phone: [phone]; National Animal Disease Center, U.S. Department of
Agriculture, Ames, Iowa 50010, Phone: [phone].
A special committee of the American Society for Microbiology will
conduct an annual review of this appendix, and its recommendations for
changes will be presented to the Recombinant DNA Advisory Committee as
proposed amendments to the NIH Guidelines.
Appendix B-I: Risk Group 1 (RG1) Agents
RG1 agents are not associated with disease in healthy adult humans.
Examples of RG1 agents include asporogenic Bacillus subtilis or Bacillus
licheniformis (see Appendix C-IV-A, Bacillus subtilis or Bacillus lichenifor-
mis Host-Vector Systems, Exceptions ); adeno-associated virus (AAV) types
1 through 4; and recombinant AAV constructs, in which the transgene
does not encode either a potentially tumorigenic gene product or a toxin
molecule and are produced in the absence of a helper virus. A strain of
Escherichia coli (see Appendix C-II-A, Escherichia coli K-12 Host-Vector
Systems, Exceptions ) is an RG1 agent if it (1) does not possess a complete
lipopolysaccharide (i.e., lacks the O antigen); and (2) does not carry any
active virulence factor (e.g., toxins) or colonization factors and does not
carry any genes encoding these factors.