Federal Register / Vol. 47, No. 77 / Wednesday, April 21, 1982 / Notices 
17193 
rubber gloves. The face velocity of the 
inward flow of air through the full-width open 
front is 75 feet per minute or greater. A Class 
1/ cabinet is a ventilated cabinet for 
personnel and product protection having an 
open front with inward air flow for personnel 
protection, and HEPA filtered mass 
recirculated air flow for product protection. 
The cabinet exhaust air is filtered through an 
HEPA filter. The face velocity of the inward 
flow of air through the full-width open front is 
75 feet per minute or greater. Design and 
performance specifications for Class // 
cabinets have been adopted by the National 
Sanitation Foundation, Ann Arbor. Michigan. 
A Class III cabinet is a closed-front 
ventilateij cabinet of gas-tight construction 
which provides the highest level of personnel 
protection of all biohazard safety cabinets. 
The interior of the cabinet is protected from 
contaminants exterior to the cabinet. The 
cabinet is fitted with arm-length rubber 
gloves and is operated under a negative 
pressure of at least 0.5 inch water gauge. All 
supply air is filtered through HEPA filters. 
Exhaust air is filtered through two HEPA 
filters or one HEPA filter and incinerator 
before being discharged to the outside 
environment. 
21. Hershfield, V., H. W. Boyer, C. 
Yanofsky, M. A. Lovett, and D. R. Helinski 
(1974). Plasmid ColEI as a Molecular Vehicle 
for Cloning and Amplification of DN A. Proc. 
Nat. Acad. Sci. USA 71, 3455-3459. 
22. Wensink, P. C., D. J. Finnegan, J. E. 
Donelson, and D. S. Hogness(1974). A System 
for Mapping DNA Sequences in the 
Chromosomes of Drosophila Melanogaster. 
Cell 3, 315-335. 
23. Tanaka, T., and B. Weisblum (1975). 
Construction of a Colicin EI-R Factor 
Composite Plasmid In Vitro: Means for 
Amplification of Deoxyribonucleic Acid. J. 
Bacteriol. 121, 354-362. 
24. Armstrong, K. A., V. Hershfield. and D. 
R. Helinski (1977). Gene Cloning and 
Containment Properties of Plasmid Col El 
and Its Derivatives, Science 196, 172-174. 
25. Bolivar, F., R. L. Rodriguez, M. C. 
Bethlach, and H. W. Boyer(1977). 
Construction and Characterization of New 
Cloning Vehicles; /. Ampicillin-Resistant 
Derivative ofpMBQ. Gene 2, 75-93. 
26. Cohen, S. N., A. C. W. Chang, H. Boyer, 
and R. Helling (1973). Construction of 
Biologically Functional Bacterial Plasmids in 
Vitro. Proc. Natl. Acad. Sci. USA 70, 3240- 
3244. 
27. Bolivar, F., R. L. Rodriguez, R. J. Greene, 
M. C. Batlach, H. L. Reyneker, H. W. Boyer, J. 
H. Crosa, and S. Falkow(1977). Construction 
and Characterization of New Cloning 
Vehicles: II. A Multi-Purpose Cloning 
System. Gene 2, 95-113. 
28. Thomas, M., J. R. Cameron, and R. W. 
Davis (1974). Viable Molecular Hydrids of 
Bacteriophage Lambda and Eukaryotic DNA. 
Proc. Nat. Acad. Sci. USA 71, 4579-4583. 
29. Murray, N. E., and K. Murray (1974). 
Manipulation of Restriction Targets in Phage 
Lambda to Form Receptor Chromosomes for 
DNA Fragments. Nature 251, 476-481. 
30. Rambach, A., and P. Tiollais (1974). 
Bacteriophage Having EcoRI Endonuclease 
Sites Only in the Non-Essential Region of the 
Genome. Proc. Nat. Acad. Sci., USA 71, 3927- 
3930. 
31. Blattner, F. R., B. G. Williams, A. E. 
Bleche. K. Denniston-Thompson, H. E. Faber, 
L. A. Furlong, D. J. Gunwald, D. O. Kiefer, D. 
D. Moore, J. W. Shumm, E. L. Sheldon, and O. 
Smithies (1977). Charon Phages: Safer 
Derivatives of Bacteriophage Lambda for 
DNA Cloning. Science 196, 163-169. 
32. Donoghue, D. J., and P. A. Sharp (1977). 
An Improved Lambda Vector: Construction of 
Model Recombinants Coding for Kanamycin 
Resistance, Gene 1, 209-227. 
33. Leder, P., D. Tiemeier and L. Enquist 
(1977). EK2 Derivatives of Bacteriophage 
Lambda Useful in the Cloning of DNA from 
Higher Organisms: The \gt WES System. 
Science 196, 175-177. 
33A. Skalka, A. (1978). Current Status of 
Coliphage X EK2 Vectors. Gene 3, 29-35. 
33B. Szybalski, W., A. Skalka, S. 
Gottesman, A. Campbell, and D. Botstein 
(1978). Standardized Laboratory Tests for 
EK2 Certification. Gene 3, 36-38. 
35. Defined as observable under optimal 
laboratory conditions by transformation, 
transduction, phage infection, and/or 
conjugation with transfer of phage, plasmid, 
and/or chromosomal genetic information. 
Note that this definition of exchange may be 
less stringent than that applied to exempt 
organisms under Section III-D-4. 
36. 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. 
48. A USDA permit, required for import and 
interstate transport of pathogens, may be 
obtained from the Animal and Plant Health 
Inspecton Service, USDA, Federal Building. 
Hyattsville, MD 20782. 
49. A subset of non-conjugative plasmid 
vectors are also poorly mobilizable (e.g., pBR 
322, pBR313). Where practical, these vectors 
should be employed. 
50. 1.e., the total of all genomes within a 
Family shall not exceed two-thirds of the 
genome. 
51. All activities, inlcuding storage of 
variloa 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, and individual 
intending to carry out research involving 
recombinant DNA is encouraged to 
affiliate with an institution that has an 
Institutional Biosafety Gommittee 
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 (ORDA) 
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-D-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-D-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-D-2-d is modihed tQ 
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 Section II-D-2-a. 
Institutions not otherwise covered by 
the Guidelines will not be subject to 
Section II-D-3 by complying with these 
procedures. 
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 
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