September 10, 1987 
IBA 
Industrial 
Biotechnology 
Association 
1625 K Street, N.W. 
Suite 1100 
Washington, D.C. 20006 
(202) 857 0244 
FAX: (202) 857 0237 
Dr. William J. Gartland, Jr. 
Director 
Office of Recombinant DNA Activities 
12441 Parklawn Drive 
Suite 58 
Rockville, Maryland 20852 
Alan R. Goldhammer, Ph.D. 
Director of Dear Bill: 
Technical Affairs 
Directors 
Officers 
Chairman 
George B. Rathmann 
Amgen 
Vice Chairman 
Hugh A. D'Andrade 
Schering-Plough Corp. 
Secretary 
John R. Norell 
Phillips Petroleum Co. 
Treasurer 
Jerry D. Caulder 
Mycogen Corporation 
Ronald E. Cape 
Cel us Corporation 
Will D. Carpenter 
Monsanto Company 
Ralph E. Christoffersen 
The Upjohn Company 
Nicholas M. Frey 
Pioneer Hi-Bred 
International, Inc. 
The following comments on the proposed modifications of the NIH 
Guidelines (52 FR 29800) are submitted on behalf of the Industrial 
Biotechnology Association (IBA). Many IBA companies have active 
research programs in the agricultural biotechnology area. These 
projects involve modification of both plants and microorganisms using 
recombinant DNA techniques. Since such research will necessarily 
involve greenhouse testing, IBA has reviewed this present proposal to 
modify the NIH Guidelines with considerable interest. 
IBA recognizes that a significant amount of work went into the 
development of these proposals. Generally the proposals are sound 
and consistent with the existing laboratory research guidelines. 
However, we would offer the following suggestions that we believe 
will improve the overall consistency of the approach. We have 
referred to the sections as numbered in the Federal Register 
announcement . 
Paragraph 89 
We recommend changing the wording to: "A record is kept of 
experiments in progress in the facility." Many times an 
investigator will be removing soil samples or plant parts from the 
greenhouse to a labortory for characterization. To "log" each of 
these events will result in a bookkeeping burden that is not 
consistent with the risk of experiments that are permitted at this 
containment level. 
Paragraph 91c 
L. Patrick Gage 
Hoffmann-La Roche. Inc. 
Ralph W. F. Hardy 
BioTechnica International. Inc. 
David A. Jackson 
E.I. du Pont de Nemours & Co. 
Gabriel Schmergel 
Genetics Institute. Inc. 
We recommend deleting this requirement. IBA would point out 
that the four levels of greenhouse containment proposed here are to 
correspond with the laboratory containment conditions BL1-4 that are 
in the present guidelines. The posting of the biohazard warning sign 
is a requirement only for experiments carried out under conditions BL 
2-4. 
Hubert J. P. Schoemaker 
Centocor 
Robert A. Swanson 
Genentech. Inc 
[354] 
Recombinant DNA Research, Volume 13 
