Federal Register / Vol. 45, No. 227 / Friday, November 21, 1980 / Notices 
77405 
be advised; and the actual release will 
not be made until the expiration of 15 
days after the institution is so advised, 
except to the extent that earlier release, 
in the judgement of the Director, NIH, is 
necessary to protect against an 
imminent hazard to the public or the 
environment. 
Vl-F-4. Projects should be registered 
in accordance with procedures specified 
in the Administrative Practices 
Supplement. The following information 
will usually be considered publicly 
available information, consistent with 
the need to protect proprietary data: 
a. The names of the institution and 
principal investigator. 
b. The location where the experiments 
will be performed. 
c. The host-vector system. 
d. The source of the DNA. 
e. The level of physical containment. 
VI-F-5-a. Any institution not 
otherwise covered by the Guidelines, 
which is considering submission of data 
or information voluntarily to NIH, may 
request presubmission review of the 
records involved to determine whether, 
if the records are submitted, NIH will or 
will not make part or 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 determination, 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 by 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 was received 
from them under the Act. 
Appendix A — Exemptions Under I-E-4 
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 propagated in any of the 
organisms within a sublist. 
(Classification 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) 
B. Genus Klebsiella 
7. Genus Erwinia 
8. Pseudomonas aeruginosa, Pseudomonas 
putida and Pseudomonas fluorescens 
9. Serratia marcescens 
Sublist B 
1. Bacillus subtilis 
2. Bacillus licheniformis 
3. Bacillus pumilus 
4. Bacillus globigii 
5. Bacillus niger 
6. Bacillus nato 
7. Bacillus 'amyloliquefaciens 
8. Bacillus aterrimus 
Sublist C 
1. Streptomyces aureofaciens 
2. Streptomyces rimosus 
3. Streptomyces coelicolor 
Sublist D 
1. Streptomyces griseus 
2. Streptomyces cyaneus 
3. Streptomyces venezuehe 
Sublist E 
One way transfer of Streptococcus mutans 
DNA into Streptococcus sanguis. 
Sublist F 
1. Streptococcus sanguis 
2. Streptococcus pneumoniae 
Appendix B — Classification of Micro- 
Organisms on the Basis of Hazard 
I. Classification of Etiologic Agents on 
the Basis of Hazard (7) 
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. 
renal e 
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, N. 
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 
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