Federal Register / Vol. 47, No. 102 / Wednesday, May 26, 1982 / Notices 
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4. Classification of Etiologic Agents on the 
Basis of Hazard. (4th Edition, July 1974). U.S. 
Department of Health, Education, and 
Welfare. Public Health Service. Centers for 
Disease Control, Office of Biosafety, Atlanta. 
Georgia 30333. 
5. National Cancer Institute Safety 
Standards for Research Involving Oncogenic 
Viruses (Oct. 1974). U.S. Dpeartment of 
Health, Education, and Welfare Publication 
No. (NIH) 75-790. 
6. National Institutes of Health Biohazards 
Safety Guide (1974). U.S. Department of 
Health, Education, and Welfare, Public 
Health Service, National Institutes of Health. 
U.S. Government Printing Office, Stock No. 
1740-00383. 
7. Biohazards in Biological Research 
(1973). A. Heilman, M. N. Oxman, and R. 
Pollack (ed.) Cold Spring Harbor Laboratory. 
8. Handbook of Laboratory Safety (9171). 
Second Edition. N. V. Steere (ed.). The 
Chemical Rubber Co., Cleveland. 
9. Bodily, J. L. (1970). General 
Administration of the Laboratory, H. L. 
Bodily, E. L. Updyke, and J. O. Mason (eds.). 
Diagnostic Procedures for Bacterial, Mycotic 
and Parasitic Infections. American Public 
Health Association, New York, pp. 11-28. 
10. Darlow, H. M. (1969). Safety in the 
Microbiological Laboratory. In J. R. Norris 
and D. W. Robbins (ed.). Methods in 
Microbiology. Academic Press, Inc, New 
York, pp. 169-204. 
11. The Prevention of Laboratory Acquired 
Infection (1974). C. H. Collins, E. G. Hartley, 
and R. Pilsworth. Public Health Laboratory 
Service, Monograph Series No. 6. 
12. Chatigny, M. A. (1961). Protection 
Against Infection in the Microbiological 
Laboratory: Devices and Procedures. In W. 
W. Umbreit (ed.). Advances in Applied 
Microbiology. Academic Press, New York, 
N.Y. 3:131-192. 
13. Design Criteria for Viral Oncology 
Research Facilities (1975). U.S. Department 
of Health, Education and Welfare, Public 
Health Service, National Institutes of Health, 
DHEW Publication No. (NIH) 75-891. 
14. Kuehne, R. W. (1973). Biological 
Containment Facility for Studying Infectious 
Disease. Appl. Microbiol. 26-239-243. 
15. Runkle, R. S., and G. B. Phillips (1969). 
Microbial Containment Control Facilities. 
Van Nostrand Reinhold, New York. 
16. Chatigny, M. A., and D. I. Clinger (1969). 
Contamination Control in. Aerobiology. In R. 
L. Dimmick and A, B. Akers (eds.). An 
Introduction to Experimental Aerobiology. 
John Wiley & Sons. New York, pp. 194-263. 
17. As classified in the Third Report of the 
International Committee on Taxonomy of 
Viruses: Classification and Nomenclature of 
Viruses, R. E. F. Matthews, Ed. Intervirology 
12 (129-296) 1979. 
18. A USDA permit, required for import and 
interstate transport of pathogens, may be 
obtained from the Animal and Plant Health 
Inspection Service, USDA, Federal Building, 
Hayttsville, MD 20782. 
19. i.e., the total of all genomes within a 
Family shall not exceed two-thirds of the 
genome. 
20. All activities, including storage of 
variola and whitepox are restricted to the 
single national facility (World Health 
Organization (WHO) Collaborating Center 
for Smallpox Research, Centers for Disease 
Control, in Atlanta). 
VI. Voluntary Compliance 
VI-A. Basic Policy. Individuals, 
corporations, and institutions not 
otherwise covered by the Guidelines are 
encouraged to do so by following the 
standards and procedures set forth in 
Parts I-IV of the Guidelines. In order to 
simplify discussion, references hereafter 
to “institutions” are intended to 
encompass corporations, and 
individuals who have no organizational 
affiliation. For purposes of complying 
with the Guidelines, an individual 
intending to carry out research involving 
recombinant DNA is encouraged to 
affiliate with an institution that has an 
Institutional Biosafety Committee 
approved under the Guidelines. 
Since commercial organizations have 
special concerns, such as protection of 
proprietary data, some modifications 
and explanations of the procedures in 
Parts I-IV are provided below, in order 
to address these concerns. 
VI-B. IBC Approval. The NIH Office 
of Recombinant DNA Activities (ORDAJ 
will review the membership of an 
institution's Institutional Biosafety 
Committee (IBC) and, where it finds the 
IBC meets the requirements set forth in 
Section IV-B-2, will give its approval to 
the IBC membership. 
It should be emphasized that 
employment of an IBC member solely 
for purposes of membership on the IBC 
does not itself make the member an 
institutionally affiliated member for 
purposes of Section IV-B-2-a. 
Except for the unaffiliated members, a 
member of an IBC for an institution not 
otherwise covered by the Guidelines 
may participate in the review and 
approval of a project in which the 
member has a direct financial interest, 
so long as the member has not been and 
does not expect to be engaged in the 
project. Section IV-B-2-d is modified to 
that extent for purposes of these 
institutions. 
VI-C. Certification of Host-Vector 
Systems. A host-vector system may be 
proposed for certification by the 
Director, NIH, in accordance with the 
procedures set forth in Appendix I-II-A. 
In order to ensure protection for 
proprietary data, any public notice 
regarding a host-vector system which is 
designated by the institution as 
proprietary under Section VI-E-1 will be 
issued only after consultation with the 
institution as to the content of the 
notice. 
VI-D. Requests for Exemptions and 
Approvals. Requests for exemptions or 
other approvals required by the 
Guidelines should be requested by 
following the procedures set forth in the 
appropriate sections in Parts I-IV of the 
Guidelines. 
In order to ensure protection for 
proprietary data, any public notice 
regarding a request for an exemption or 
other approval which is designated by 
the institution as proprietary under 
Section VI-E-1 will be issued only after 
consultation with the institution as to 
the content of the notice. 
VI-E. Protection of Proprietary Data. 
In general, the Freedom of Information 
Act requires Federal agencies to make 
their records available to the public 
upon request. However, this requirement 
does not apply to, among other things, 
"trade secrets and commercial and 
financial information obtained from a 
person and privileged or confidential." 
18 U.S.C. 1905, in turn makes it a crime 
for an officer or employee of the United 
States or any Federal department or 
agency to publish, divulge, disclose, or 
make known “in any manner or to any 
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, 
jor 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-E-1. In submitting information to 
NIH for purposes of complying 
voluntarily with the Guidelines, and 
institution may designate those items of 
information which the institution 
believes constitute trade secrets or 
privileged or confidential commercial or 
financial information. 
VI-E-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-E-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 
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