Federal Rejieter / Vol. 47. No. 167 / Friday. August 27. 1982 / Notices 
38055 
suspension, limitation, or termination of 
NIH funds for recombinant DNA 
research at the Institution, or (li) a 
requirement for prior NIH approval of 
any or ail recombinant DNA projects at 
the Institution. 
IV-D-3. Information concerning 
noncompliance with the Guidelines may 
be brought forward by any person. It 
should be delivered to both NIH 
(ORDA) and the relevant Institution. 
The Institution, generally through the 
IBC. shall take appropriate action. Tihe 
Institution shall forward a complete 
report of the incident to OROA 
recommending any further action 
indicated. 
rV-O-4. In cases where NIH proposes 
to suspend, limit, or terminate fioandat 
assistance because of noncompliance 
with the Guidelines, applicable DHHS 
and Public Health Service Procedures 
shall govern. 
See Appendix | for information on the 
Federal Interagency Advisory 
Committee on Recombinant DNA 
Research. 
rV-D-5. Voluntary Compliance. Any 
individual, corporation, or Institution 
that is not otherwise covered by the 
Guidelines is encouraged to conduct 
recombinant DNA research activities In 
accordance with the Guidelines, through 
the procedures set forth in Part VI. 
V. Foobioiea sod Refaraaces of Sactloos l-IV 
1. Tha original rafaranca lo otganiama as 
Oaaa 1. 2, 1 4. or S rafara to the ciasaiAcailon 
In tba publicallon CJaatificaUon of EUo logic 
AmoU on the Boot» of Hatard. 4th Edition. 
July 1074; U.S. Dapartmanl of Haallh. 
Education, and Walfara. Public Health 
Sarvica. Canlara for Disease Control OfTtca 
of Biosafety. Atlanta. Ceorfia 30933. 
The Oiractor. ND-L with advice of tha 
Rscombtnanl DNA Advisory Coeunltlaa. may 
ravlae lha classification for the purposes of 
these Culdellnes (sea Section (V-C-l-b-(2>- 
(d)). The raviaad list of organisms In each 
dsM is reprinted in Appendix B to these 
Guidelines. 
2. In Part 111 of the Guidelines, there are a 
number of places where fudgments are to be 
made In aU these cases the principal 
Investifstor is to make the (udgment on these 
matters as pari of his reepoiMlbility to "make 
the initial daterailnation of the required 
levels of physical and biolofical containment 
In accordance with the Gui^lines** (Section 
rV-B-5-c-(l)). In the cases falling uitder 
Sections Ill-A. -6 or -C this pid|tiaeni Is lo 
be reviewed and approved by the 
liutitutional Biosafety Committee as part of 
its responsibility lo make "an uidependent 
assessment of the conlaiiunent levels 
required by these Guidelines for tha proposed 
research' (Section IV-B-3-e-<l)). If the IBC 
wishes, any specific cases may ^ referred lo 
the NIH Office of Recombinant DNA 
Activities as part of ORDA's functions lo 
“provide advice lo all within and outside 
NIH" (Section rV-C-3). and ORDA may 
request advice from the Reooaibinant DNA 
Advisory Committee as part of the RAC s 
responsibiUty for "interpreting and 
determining coolainment levels upon request 
by ORDA" (Section rV-C-l-b-(2Ha)I. 
3. Laboratory Safety at the Center for 
Disease Control (Sept 1974). U.S. Department 
of Health Education and Welfare Publication 
No. CDC 75-em 
4. Classification ofEtiologic Agents on the 
Basis of Hosard. (4th Edition, July 1974). U.& 
Department of Health. Education and 
Welfare. Pubbe 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). UA Department of 
Haalth. Education and Welfare Publication 
No. (NIH) 75-790. 
0. Notional Institutes of Health Biohatards 
Safely Guide (1074). U.S. Department of 
Health. Education, and Wstfare. PubUc 
Health Service. National Insntutes of Health. 
UA Govemmenl Printing Office. Stock No. 
1740-00333. 
7. Biohasards in Biological Research 
(1073). A Hallman, kl N. Oxman. and R 
Pollack (ad.) Cold Spring Harbor Laboratory. 
8. Handbook of Laboratory Safety (1971). 
Second Edition. N. V. Steers (ed.). The 
Chemical Rubber Co.. Geveland 
9. Bodily. ). L (1970) Cenerol 
Adminstrotion of the Laboratory. K L 
Bodily. B L Updyke. and ). O. Mason (eda) 
Dtsgnoatic Procedures for Bacterial Idyootic 
and Parasitic Infactiona Amencan Public 
Haalth Association. Nsw York. pp. 11-2A 
la Darlow, H. M. (1908) Safety in the 
Microbiological Laboratory. In ). R Norris 
and D. W Robbins (ed.) Method in 
Microbiology. Academic Press. Inc. New York 
pp ieO-204 
11. The Prevention of Laboratory Acquired 
Infection (1974) Q K Coftina E. C. Hartley, 
arid R PU^orlh. Public Health Laboratory 
Sarvica. Monograph Sariea Na 6. 
12. ChoUgny. M. A. (t06t). Protection 
Against Infection in the Microbiological 
Loboralcry: Devices and Procedures. In W. 
W. Umbrelt (ad.) Advancaa in Applied 
Microbiology. Acadamic Pteaa. New York. 
N Y. 3131-192. 
IX Design Criteria for Virol Oncology 
Research PociUtiee (1975). U.S. Department 
of Haalth. Bdacallofv and Walfara. Public 
Haalth Sarvica. NaUonal butitulaa of Haalth. 
DHFW Publication Na (NIH) 75-991. 
14. Kuebna. R. W. (1973). Bidogicol 
Containment Facility for Studying Infectious 
Disease. Appl Microbiol 29-239-24X 
IX Runkie. R. S.. and G. B. Phillips (1999) 
Microbial Containment Control Facilities. 
Van Noatrand Reinhold. New York. 
IX Chattgny. M. A., and D. I Ginger (1998). 
Contamination Control in Aerobiology. In R. 
L Dimmick and A B. Akers (eds.) An 
Introductioo lo Experimental Aerobiology. 
)ohn Wilay 9 Sons. New York. pp. 194-2SX 
17. As classified in tha Third Report of the 
International Commiitee on Taxonomy of 
Viruses Clsssificslion snd Nomencistura of 
Viruses. R. R F. Malthewa. Ed. Inlervirology 
12 (129-296) 1979 
18. A USDA penniL required for import and 
interest transport of psthogens. may be 
obtained from the Animal artd Plant Health 
Inspection Service. USDA, Federal Building. 
Hyattsville. MD 20782. 
19. i.a- 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 
tingle national facility (World Health 
Organization (WHO) Collaborating Center 
for Smallpox Research, Centers for Disease 
Control, ta Atlanta) 
VI. Voluntary Corapllanco 
Vl-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 WV 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. 
Vl-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-B-2. give its approval to 
the IBC membership. 
It should be emphasized that 
employment of an IBC member solely 
for purposes of membership on the I^ 
does not itself make the member an 
institutionally affiliated member for 
purposes of Action IV-B-2-a. 
Except for the unaffUiated 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. 
Vl-C. Certification of Host-Vector 
Systems. A host-vector system may be 
proposed lor 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 
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