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Federal Register / Vol. 47, No. 102 / Wednesday, May 26. 1982 / Notices 
imminent hazard to the public or the 
environment 
Vl-E-4. Presubmission Review. 
Vl-E' 4 - a . Any institution not 
otherwise covered by the Guidelines, 
which is considering submission of data 
Information voluntarily to NIH. may 
request presubmission review of the 
records involved to determine whether, 
if the records are submitted, NIH will or 
tvill not make part or all of the records 
available upon request under the 
Freedom of Information Act 
Vl-E-4-b. A request for 
presubmission review should be 
submitted to OROA, along with the 
records involved. These records must be 
clearly marked as being the property of 
the institutioa 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 HHS Freedom of Information 
Officer, the responsible ofTicial under 
HHS regulations (45 C.F.R. Part 5), as to 
whether the reco^s involved (or some 
portion) are or are not available to 
members of the public under the 
Freedom of Information Act. Pending 
such a determination, the records will 
be kept separate from OROA files, will 
be considered records of the institution 
and not OROA. and will not be received 
as part of OROA files. No copies will be 
made of the records. 
VI-E-4-c»OROA will inform the 
institution of the HHS 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 by HHS. NIH. or ORDA. 
VI-E-4-d. The HHS Freedom of 
Information Officer's determination will 
represent that official's judgment, as of 
the time of the determination, as to 
whether the records involved (or some 
portion) would be exempt. 
Appendix A. — Exemption* Under III-D-4 
Section IlI-D-4 state* that exempt from 
these Guidelines are "certain specifled 
recombinant DNA molecules that consist 
entirely of DNA segments from different 
species that exchange DNA by known 
physiological processes, thou^ 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. NIR with advice of the RAC. after 
appropriate notice and opportunity for public 
comment (See Section IV-C-l-b-{lHc).) 
Certain classes are exempt as a publication 
of these Revised Guidelines. The list is in 
Appendix A." 
Under Section U1-D-4 of these Guidelines 
are recombinant DNA motocules 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 (ClassiGcaiion of 
Bergey's Manual of Determinative 
Bacteriology, eighth 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. Genus Erwinia 
8. Pseudomonas aeruginosa. Pseudomonas 
putida and Pseudomonas fluorescens 
9. Serratia marcescens 
10. Yersinia enterocolitica 
Sublist B 
1. Bacillus subtilis 
2. Bacillus licheniformis 
3. Bacillus pumilus 
4. Bacillus globigii 
5. Bacillus niger 
0. Bacillus nato 
7. Bacillus amyloiguefaaens 
8. Bacillus aterrimus 
Sublist C 
1. Streptomyces aureofaciens 
2. Streptomyces rimosus 
3. Streptomyces coelicolor 
Sublist D 
1. Streptomyces griseus 
2. Streptomyces cyaneus 
3. Streptomyces venezuelae 
Sublist E 
One way transfer of Streptococcus mutans or 
Streptococcus lactis DNA into 
Streptococcus sanguis 
Sublist F 
1. Streptococcus sanguis 
2. Streptococcus pneumoniae 
3. Streptococcus faecalis 
4. Streptococcus pyogenes 
Appendix B.— Classification of 
Microoganisms on the Basis of Hazard 
Appendix B-I. Classification of Etiologic 
Agents. (The original reference for this 
classification was the publication 
‘Classification of Etiological Agents on the 
Basis of Hazard." 4th editioa )uly 1974. U.S. 
Department of Health. Education, and 
Welfare. Public Health Service, Center for 
Disease Control. Office of Biosafety, Atlanta, 
Georgia 30333. For the pusposes of these 
Guidelines, this list has been revised by the 
NIH.) 
Appendix B-l-A. Class 1 Agents. All 
bacterial, parasitic, fungal, viral, rickettsial, 
and chlamydial agents not included in higher 
classes. 
Appendix B-I-B. Class 2 Agents 
Appendix B-I-B-1. Bacterial Agents 
Actinobacillus — all species except A. 
mallei, which is in Class 3 
Aeromonas hydrophila 
Arizona hinshawii — all serotypes 
Bacillus anthracis 
Bordetella — all species 
Borrelia recurrentis. B. vincenti 
Campylobacter fetus 
Campylobacter jejuni. 
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 
Diplococcus (Streptococcus) pneumoniae 
Edwardsiella tarda 
Erysipelothrix insidiosa 
Escherichia coli — all enteropathogenic. 
enterotoxigenic, enteroinvasive and 
strains bearing K1 antigen 
Haemophilus ducreyi, H. influenzae 
hereUae vaginicola 
Klebsiella — all species and all serotypes 
Leptospira interrogans — all serotypes 
Listeria — all species 
Mima polymorpha 
Moroxella — 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. N. meningitidis 
Pasterurella — all species except those 
listed in Class 3 
Salmonella — all species and al serotypes 
Shigella — all species and all serotypes 
Sphaerophorus necrophorus 
Staphylococcus oureus 
Streptobacillus moniliformis 
Stretococcus pyogenes 
Treponema carateum, T. pallidum, and T. 
perienue 
Vibrio fetus, V. comma, including biotype 
El Tor and V. parahemolyticus 
Yersinia enterocolitica 
Appendix B-I-B-2. Fungal Agents 
Actinomycetes (including Nocardia species 
and Actinomyces species and Arachnia 
propionica) (2) 
Blastomyces dermatitidis 
Cryptococcus neoformans 
Paracoccidioides braziliensis 
Appendix B-I-B-3. Parasitic Agents 
Endamoeba histolytica 
Leishmania sp. 
Naegleria gruberi 
Toxoplasma gondii 
Toxocara canis 
Trichinella spiralis 
Trypanosoma cruzi 
Appendix B-I-B-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 
[447] 
