Federal Register / Vol. 45, No. 20 / Tuesday. January 29, 1980 / Notices 
6747 
will not make part of all of the records 
available upon request under the 
Freedom of Information Act. 
VI-F-5-b. A request for 
presubmission review should be 
submitted to ORDA, along with the 
records involved. These records must be 
clearly marked as being the property of 
the institution, on loan to NIH solely for 
the purpose of making a determination 
under the Freedom of Information Act. 
ORDA will then seek a determination 
from the HEW Freedom of Information 
Officer, the responsible official under 
HEW regulations (45 CFR Part 5), as to 
whether the records involved (or some 
portion) are or are not available to 
members of the public under the 
Freedom of Information Act. Pending 
such a deter nination, the records will 
be kept separate from ORDA files, will 
be considered records of the institution 
and not ORDA, and will not be received 
as part of ORDA Files. No copies will be 
made of the records. 
VI-F-5-c. ORDA will inform the 
institution of the HEW Freedom of 
Information Officer's determination and 
follow the institution's instructions as to 
whether some or all of the records 
involved are to be returned to the 
institution or to become a part of ORDA 
files. If the institution instructs ORDA to 
return the records, no copies or 
summaries of the records will be made 
or retained bv HEW, NIH, or ORDA. 
VI-F-5-d. the HEW Freedom of 
Information Officer’s determination will 
represent that official's judgement, as of 
the time of the determination, as to 
whether the records involved (or some 
portion) would be exempt from 
disclosure under the Freedom of 
Information Act. if at the time of the 
determination the records were in 
ORDA files and a request were received 
from them under the Act. 
Appendix A 
Section I-E-4 states that exempt from these 
Guidelines are "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. A list of such exchangers will be 
prepared and periodically revised by the 
Director. NIH. with advice of the 
Recombinant DNA Advisory Committee, 
after appropriate notice and opportunity for 
public comment (see Section IV-E-l-b-(l)- 
(d).) Certain classes are exempt as of 
publication of these Revised Guidelines. The 
list is in Appendix A." 
Under exemption I-E-4 of these revised 
Guidelines are 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 propagaated in 
any of the organisms within a sublist. 
(Classification of Bergey's Manual of 
Determinative Bacteriology, eight edition. R 
E. Buchanan and N. E. Gibbons, editors. 
Williams and Wilkins Company: Baltimore. 
1974.) 
Sublist A 
1. Genus Escherichia 
2. Genus Shigella 
3. Genus Salmonella (including Arizona ) 
4. Genus Enterobacter 
5. Genus Citrobacter (including Levinea ) 
6. Genus Klebsiella 
7. Erwinia amylovora 
8. Pseudomonas aeruginosa. Pseudomonas 
putidu and Pseudomonas fluorescens 
9. Serratia marcescens 
Sublist B 
1. Bacillus subtil is 
2. Bacillus licheniformis 
3. Bacillus pumilus 
4. Bacillus globigii 
5. Bacillus niger 
6. Bacillus nato 
7. Bacillus anyloliquefacieps 
8. Bacillus atcrrimus 
Sublist C 
1. Streptomyces aureofaciens 
2. Steptomyces rimosus 
3. Streptomyces coelicolor 
Sublist D 
1. Streptomyces griseus 
2. Streptomyces cyaneus 
3. Streptomyces Venezuelan 
Appendix B. — Classification of 
Microorganisms on the Basis of Hazard 
I. Classification of Etiologic Agents on the 
Basis of Hazard (1). 
A. Class 1 Agents: All bacterial, parasitic, 
fungal, viral, rickettsial, and chlamydial 
agents not included in higher classes. 
B. Class 2 Agents: 
1. Bacterial Agents 
Actinobacillus — all species except A. mallei. 
which is in Class 3 
Arizona hinshawii — all serotypes 
Bacillus anthracis 
Bordetella — all species 
Borrelia recurrentis. B. vincenti 
Clostridium botulinum. 
Cl. chauvoei. Cl. haemolyticum. 
Cl. histolyticum. Cl. novyi. 
Cl. septicum, Cl. tetani 
Corynebacterium diptheriae. 
C. equi. C. haemolyticum. 
C. pseudotuberculosis. 
C. pyogenes. C. renale 
Diplococcus (Streptococcus) pneumoniae 
Erysipelothrix insidiosa 
Escherichia coli — all enteropathogenic 
serotypes 
Haemophilus ducreyi. H. influenzae 
Herellae vaginicola 
Klebsiella — all species and all serotypes 
Leptospira interrogans — all serotypes 
Listeria — all species 
Mima polymorpha 
Moraxella — all species 
Mycobacteria — all species except those 
listed in Class 3 
Mycoplasma — all species except 
Mycoplasma mycoides and Mycoplasma 
agalactiae. which are in Class 5 
Neisseria gonorrhoeae. hi. meningitidis 
Pasteurella — all species except those listed in 
Class 3 
Salmonella — all species and all serotypes 
Shigella — all species and all serotypes 
Sphaerophorus necrophorus 
Staphylococcus aureus 
Streptobacillus moniliformis 
Streptococcus pyogenes 
Treponema carateum. T. pallidum, and T. 
pertenue 
Vibrio fetus. V. comma, including biotype El 
Tor. and V. parahemolyticus 
2. Fungal Agents 
''Actinomycetes (including Nocardia species 
and Actinomyces species and Arachnia 
propionica) 
Blastomyces dermatitidis 
Cryptococcus neoformans 
Paracoccidioides brasiliensis 
3. Parasitic Agents 
Endamoeba histolytica 
Leishmania sp. 
Naegleria gruberi 
Toxoplasma gondii 
Toxocara cam's 
Trichinella spiralis 
Try panosoma cruzi 
4. Viral, Rickettsial, and Chlamydial Agents 
Adenoviruses — human — all types 
Cache Valley virus 
Coxsackie A and B viruses 
Cytomegalo viruses 
Echoviruses — All types 
Encephalomyocarditis virus (EMC) 
Flanders virus 
Hart Park virus 
Hepatitis-associated antigen material 
Herpes viruses — except Herpesvirus simiae 
(Monkey B virus) which is in Class 4 
Corona viruses 
Influenza viruses — all types except A/PR8/ 
34, which is in Class 1 
Langat virus 
Lymphogranuloma venereum agent 
Measles virus 
Mumps virus 
Parainfluenza virus — all types except 
Parainfluenza virus 3. SF4 strain, which 
is in Class 1 
Polioviruses — all types, wild and attenuated 
Poxviruses — all types except Alas trim. 
Smallpox. Monkey pox. and Whitepox. 
which depending on experiments, are in 
Class 3 or Class 4 
Rabies virus — all strains except Rabies street 
virus, which should be classified in Class 
3 when inoculated into carnivores 
Reoviruses — all types 
Respiratory syncytial virus 
Rhinoviruses — all types 
Rubella virus 
Simian viruses — all types except Herpesvirus 
simiae (Monkey B virus) and Marburg 
virus, which are in Class 4 
Sindbis virus 
Tensaw virus 
Turlock virus 
Vaccinia virus 
Varicella virus 
"'Since the publication of the classification in 
1974 |1|, the Actinomycetes have been reclassified 
as bacterial rather than fungal agents. 
[ 39 ] 
