Federal Register / Vol. 46. No. 126 / Wednesday. July 1, 1981 / Notices 
34483 
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. 
& 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. 
Vl-F-5-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 properly 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 ofTicial under 
HEW regulations (45 C.F.R. 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 flies, will 
be considered records of the institution 
and not OROA. and will not be received 
as part of ORDA flies. No copies will be 
made of the records. 
V1-F-5-C. ORDA will inform the 
Institution of the HEW Freedom of 
Information Offlcer'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 judgment, 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. — Exemptions Under l-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-B-l-b-(l)- 
(d).) Certain classes are exempt as of 
publication of these Revised Guidelines. The 
list in in Appendix A" 
Under exemption l-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 sublisL 
(Classification of Bergey't 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 Arisona] 
4. Genus Enterobacter 
5. Genus Citrobocter (including Levinea) 
e. Genus Klebsiella 
7. Genus Erwinia 
8. Pseudomonas oerugninosa. Pseudomonas 
putida and Pseudomonas fluorescens 
0. Serratia marcescens 
Sublist B 
1. Bacillus sub til is 
2. Bacillus licheniformis 
3. Bacillus pumilus 
4 Bacillus globigii 
5. Bacillus niger 
6. Bacillus nato 
7. Bacillus amyloliquefaciens 
8. Bacillus oterrimus 
Sublist C 
1. Slreplomyces aureofaciens 
2. Streptomyces rimosus 
3. Streptomyces coelicolor 
Sublist D 
1. Streptomyces griaeus 
2. Streptomyces cyaneus 
3. Streptomyces venezueloe 
Sublist E 
One way transfer of Streptococcus mutana 
DNA into Streptococcus sanguis. 
Sublisl F 
1. Streptococcus sanguis 
2. Streptococcus pneumoniae 
3. Streptococcus faecalis 
Appendix B. — Classification of 
Microorganisms on the Basis of Hazard 
Classification of Eliologic 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 .4. 
malM. which is in Class 3 
Arizona hinshawii — all serotypes 
Bacillus an th rads 
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 
Eryaipelothrix insidiosa 
Escherichia coli — all enteropathogenic 
serotypes 
Maemophilus ducreyi. H. influenzae 
Herellae vaginicola 
Klebsiella — all species and all 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 Class3 
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 caroteum. 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 canis 
Trichinella spiralis 
Trypanosoma cruzi 
4. Viral. Rickettsial, and Chlamydial 
Agents: 
Adenoviruses — human — all types 
Cache Valley virus 
1171 ] 
