69232 
Federal Register / Vol. 44, No. 232 / Friday, November 30, 1979 / Notices 
extent not authorized by law any 
information coming to him in the course 
of his employment or official duties or 
by reason of any examination or 
investigation made by, or return, report 
or record made to or filed with, such 
department or agency or officer or 
employee thereof, which information 
concerns or relates to the trade secrets, 
[or] processes ... of any person, firm, 
partnership, corporation, or 
association." This provision applies to 
all employees of the Federal 
Government, including special 
Government employees. Members of the 
Recombinant DNA Advisory Committee 
are “special Government employees.” 
VI-F-1. In submitting information to 
NIH for purposes of complying 
voluntarily with the Guidelines, an 
institution may designate those items of 
information which the institution 
believes constitute trade secrets or 
privileged or confidential commercial or 
financial information. 
VI-F-2. If NIH receives a request 
under the Freedom of Information Act 
for information so designated, NIH will 
promptly contact the institution to 
secure its views as to whether the 
information [or some portion) should be 
released. 
VI-F-3. If the NIH decides to release 
this information (or some portion) in 
response to a Freedom of Information 
request or otherwise, the institution will 
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 judgment of the Director, NIH, is 
necessary to protect against an 
imminent hazard to the public or the 
environment. 
VI-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 systenc 
d. The source of the DNA. 
e. The level of physical containment 
VI-F-5-a. Any institution not 
otherwise covered by the Guildelines, 
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 responsbile offical 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 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 
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) 
6. Genus Klebsiella 
7. Erwinia amylovora 
8. Pseudomonas aeruginosa. Pseudomonas 
putida and Pseudomonas fluorescent 
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 venezuelae 
Appendix B — Classification of 
Microorganisms on the Basis of Hazard 
/. 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-a\\ serotypes. 
Bacillus anthracis. 
Bordetella — all species. 
Borrelia recurrentis, B. vincenti. 
Clostridium botulinum, Cl. chauvoei. Cl. 
haemolyticum, Cl. histolyticum, Cl. novyi, Cl. 
septicum, Cl. letani. 
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 
'isted 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. 
[218] 
