United States 
Department of 
Agriculture 
Agricultural 
Research 
Service 
Northeastern Region 
Plum IslarKJ 
Animal Disease Center 
P.O. Box 848 
Greenport, New York 
11944 
January 29, 1982 
SUBJECT: Corments on “IVo Proposals Concerning Major Revision of NIH 
Guidelines for Research Involving Recombinant DMA Molecules 
TO: Dr. William Gartland, Director 
Office of Recombinant DNA Activities 
NIH 
Bldg. 31, Room 4A52 
Bethesda, MD 20205 
The two proposals were reviewed in detail by PIADC staff. 
Our ccrments are stnfnarized below: 
1. We advise against adaption of the RAC proposed (Federal Register 12/4/81) 
and reconnend adaption of the Oottesman proposal (Federcd Register 12/7/81) 
with seme modifications. Under 1-D prohibitions, we suggest that in addi- 
tion to those items eixrlosed by brac)cets, ie, (drug resistance) that the 
follcwing be added "and work with Class 4 and 5 agents". 
2. Genercd corment on III, Containment Levels. We are in agreement with the 
current containment levels as set forth by the proposed guidelines from CDC 
(Proposed Biosafety Guidelines for Microbiol ogiced and Bicmedical Laborator- 
ies) and by the Arbevirus Conmittee (Am. J. Trop. Med. Hyg. 29: 1359-1381, 
1980). Therefore, we suggest that the containment level for recombinant DNA 
research be that of the microorganism that is being worked with as defined 
in the above two references. Further, we recermend that the containment 
level for large scale production be one level above that for research and 
pilot "scale up" experiments. 
3. Oonoerning Section IV, Roles and Responsibilities, we would suggest that the 
Gottesman proposal be modified as follows: Level 1 and 2 research woric only 
be recorded with the local IBC; Level 3 work require prior approval of the 
local IBC and recorded with the NIH, ORDA. Finally, we recommend that work 
with Level 4 and 5 organisms and other work as noted in 1-D require prior 
approval of the local IBC and final approval of either the full RAC Carmit- 
tee or a subcenmittee of the RAC set up for such purposes. Another safe 
guard would be a requirement of inspection of Level 4 facilities by an 
expert safety committee before approval of such work. 
J. H. Graves 
H. L. Bachrach 
D. M. Moore 
J. S. Wadker 
G. Still 
[7391 
