DBA 
Director* 
Officer* 
President 
Ronald E. Cape 
Cetus Corporation 
Wee President 
Gabriel Schmergel 
Genetics Institute 
Secretary 
Hollis G. Schoepke 
G. D. Searle & Company 
Treasurer 
John E. Donalds 
The Dow Chemical Company 
Hugh A. O'Andrade 
Schering-Plough Corporation 
Richard L Easterday 
Pharmacia, Inc. 
J. Leslie Glick 
Genex Corporation 
John R. Norell 
Phillips Petroleum Company 
David J. Padwa 
Agrigenetics Corporation 
George B. Rathmann 
Amgen 
Industrial Biotechnology Association 
21 1 5 East Jefferson Street 
Rockville, Maryland 20852 
Telephone: (301 ) 984-9598 
Harvey S. Price 
Executive Director 
May 30, 1984 
Dr. William J. Gartland, Jr. 
Director, Office of Recombinant 
DNA Activities 
Building 31 , 3B10 
National Institutes of Health 
Bethesda , MD 20205 
Re: Federal Register notice for June 1 RAC meeting, 
49 F.R. 17672, 17682 (April 24, 1984) 
Dear Dr. Gartland: 
The comments below are submitted on behalf of the Industrial Biotech- 
nology Association, a trade association representing many of the leading 
companies engaged in commercial biotechnology activities. A current 
membership list is attached. 
The National Institutes of Health Recombinant DNA committee has 
solicited comments on the report "The Environmental Implications of 
Genetic Engineering" which was prepared by the Subcommittee on Investi- 
gations and Oversight of the Committee on Science and Technology of the 
U.S. House of Representatives. The issues raised in that report as they 
relate to the role of NIH-RAC are not dissimilar to those raised by Dr. 
Bernard Talbot, Deputy Director, National Institute for Allergy and Infec- 
tious Diseases at the last RAC meeting. IBA filed extensive comments at 
the time of that previous meeting and our views regarding the present and 
future roles of RAC have not changed substantially during this interim 
period. 
RAC is planning to consider at the June 1 meeting a proposal to 
change some procedures for the Scale-Up of Organisms (Appendix K of the 
Guidelines). In particular, proposal 1-3 would provide a degree of lati- 
tude in the application of Pl-LS following IBC review of appropriate data 
for a particular host-vector system. RAC has traditionally provided 
[ 696 ] 
