Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Notices 
34509 
Plant Health Inspection Service, U.S. 
Department of Agriculture, 6505 
Belcrest Road, Room 850, Hyattsville, 
Mar>'land 20782, (301) 436-7601. 
Section V-S. i.e., the total of all 
genomes within a family shall not 
exceed two-thirds of the genome. 
Section V-T. All activities, including 
storage of variola and whitepox, are 
restricted to the single national facility 
(World Health Organization 
Collaborating Center for Smallpox 
Research, Centers for Disease Control 
and Prevention, Atlanta, Georgia). 
Section V-U. Human studies in which 
the induction or enhancement of an 
immune response to a vector-encoded 
microbial immunogen is the major goal, 
such an immune response has been 
demonstrated in model systems, and the 
persistence of the vector-encoded 
immunogen is not expected, are not 
covered under Sections lII-A-2, Ill-B- 
2, or III-B-3. Such studies may be 
initiated without RAC review and NIH 
approval if approved by another Federal 
agency. 
Section V-V. For recombinant DNA 
exp>€riments in which the intent is to 
modify stably the genome of cells of one 
or more human subjects (see Sections 
III-A-2, III-B-2, and III-B-3). 
Section V-W. In accordance with 
accepted scientific and regulatory 
practices of the discipline of plant 
pathology, an exotic plant pathogen 
(e.g., virus, bacteria, or fungus) is one 
that is unknown to occur within the 
U.S. (see Section V-R). Determination of 
whether a pathogen has a potential for 
serious detrimental impact on managed 
(agricultural, forest, grassland) or 
natural ecosystems should bo made by 
the Principal Investigator and the 
Institutional Biosafety Committee, in 
consultation with scientists 
knowledgeable of plant diseases, crops, 
and ecosystems in the geographic area 
of the research. 
Appendix A. Exemptions Under Section 
III-E-5— Sublists of Natural Exchangers 
Certain specified recombinant DNA 
molecules that ‘‘consist entirely of DNA 
segments from different species that 
exchange DNA by known physiological 
processes, though one or more of the 
segments may be a synthetic equivalent 
are exempt from these NIH. Guidelines 
(see Section Dl-E-5). Institutional 
Biosafety Committee registration is not 
required for these exempt experiments. 
A list of such exchangers will be 
prepared and periodically revised by the 
Nlli Director with advice from the RAC 
after appropriate notice and opportunity 
for public comment (see Section IV-C- 
l-tMl)-{c)). See Appendices A-1 
through A-VI for a list of natural 
exchangers that are exempt from the 
NIH Guidelines.” Section lII-E-5 
describes recombinant DNA molecules 
that are: (1) composed entirely of DNA 
segments from one or more of the 
organisms within a sublist, and (2) to be 
propagated in any of the organisms 
within a sublist (see Classification of 
Bergey‘s Manual of Determinative 
Bacteriology; 8th edition, R. E. 
Buchanan and N. E. Gibbons, editors, 
Williams and Wilkins Company: 
Baltimore, Maryland 1984). Although 
these experiments are exempt, it is 
recommended that they be performed at 
the appropriate biosafety level for the 
host or recombinant organism (see 
Biosafety in Microbiological and 
Biomedical Laboratories, 3rd edition. 
May 1993, U.S. DHHS, Public Health 
Service, Centers for Disease Control, 
Atlanta, Georgia, and NIH Office of 
Biosafety, Bethesda, Maryland). 
Appendix A-I. Sublist A 
Genus Escherichia 
Genus Shigella 
Genus Salmonella — including Arizona 
Genus Enterobacter 
Genus Citrobacter — including Levinea 
Genus Klebsiella — including oxytoca 
Genus E^^^'inia 
Pseudomonas aeruginosa, Pseudomonas 
putida, Pseudomonas fluorescens, 
and Pseudomonas mendocina 
Serratia marcescens 
Yersinia enterocolitica 
Appendix A-II. Sublist B 
Bacillus subtilis 
Bacillus licheniformis 
Bacillus pumilus 
Bacillus globigii 
Bacillus niger 
Bacillus nato 
Bacillus amyloliquefaciens 
Bacillus aterrimus 
Appendix A-III. Sublist C 
Streptomyces<iureofaciens 
Streptomyces rimosus 
Streptomyces coelicolor 
Appendix A-IV. Sublist D 
Streptomyces griseus 
Streptomyces cyaneus 
Streptomyces venezuelae 
Appendix A-V. Sublist E 
One way transfer of Streptococcus 
mu tans or Streptococcus lactis DNA 
into Streptococcus sanguis 
Appendix A-VI. Sublist F 
Streptococcus sanguis 
Streptococcus pneumoniae 
Streptococcus faecalis 
Streptococcus pyogenes 
Streptococcus mutans 
Appendix B. Classification of Etiologic 
Agents and Oncogenic Viruses on the 
Basis of Hazard (See Appendix B-VI- 
A). 
Appendix B-I. Class 1 Agents 
All bacterial, parasitic, fungal, viral, 
rickettsial, and chlamydial agents not 
included in higher classes shall be 
considered Class 1 agents. 
Appendix B-II. Class 2 Agents 
Appendix B-II-A. Class 2 Bacterial 
Agents 
Acinetobacter calcoaceticus 
Actinobacillus — all species 
Aeromonas hydrophila 
Amycolata autotrophica 
Arizona hinshawii — all serotypes 
Bacillus anthracis 
Bordetella — all species 
Borrelia recurrentis, B. vincenti j- 
Campylobacter fetus | 
Campylobacter jejuni f 
Chlamydia psittaci * 
Chlamydia trachomatis 
Clostridium botulinum. Cl. chauvoei. Cl. 
haemolyticum, Cl. histolyticum. Cl. 
novyi, Cl. 
septicum, Cl. tetani 
Corynebacterium diphtheriae, C. equi, 
C. haemolyticum. C. 
pseudotuberculosis, C. 
pyogenes, C. renale 
Dermatophilus congolensis 
Edwardsiella tarda 
Erysipelothrix insidiosa 
Escherichia coli — all enteropathogenic, 
enterotoxigenic, enteroinvasive and 
strains 
bearing Kl antigen 
Haemophilus ducreyi, H. influenzae 
Klebsiella — all species except oxytoca 
Legionella pneumophila 
Leptospira interrogans — all serotypes 
Listeria — all species 
Moraxella — all species 
Mycobacteria — all species except those 
listed in Class 3 
Mycobacterium avium 
Mycoplasma — all species except 
Mycoplasma mycoides and 
Mycoplasma agalactiae, which are in 
Class 5 
Neisseria gonorrhoea, N. meningitides 
Nocardia asteroides, N. brasiliensis, N, 
otitidiscaviarum, N. transvalensis 
Pasteurella — all species except those 
listed in Class 3 
Rhodococcus equi 
Salmonella — all species and all 
serotypes 
Shigella-all species and all serotypes 
Sphaerophorus necrophorus 
Staphylococcus aureus 
Streptobacillus moniliformis 
Streptococcus pneumoniae, S. pyogenes 
Treponema carateum, T. pallidum, and 
T. pertenue 
[710] 
Recombinant DNA Research, Volume 19 
