May 19, 1988 
IBA 
Industrial 
Biotechnology 
Association 
1625 K Si reel. N.W. 
Suite 1100 
Washington, D C. 20006 
(202) 357 0244 
FAX: (202) 857 0237 
AUn R. Goldhammer. Ph.D. 
Director o I 
Technical A/fairs 
Director! 
Chairman 
George B Raihmenn 
Amgen 
Vice Chairman 
Hugh A D'Andrede 
Schenng Plough Corp 
Secrefory 
L Patrick Gage 
Hodmann La Roche. Inc 
Treoeurer 
Jerry D Caulder 
Mycogen Corporation 
Aibero E. Adam 
Amercan Cvanamid Co 
WJI D Carpenter 
Moruanto Company 
Ralph E Chnjtotlerwn 
The L piohn Company 
Nichoiai M Frey 
Pioneer Hi- Bred 
buemational. Inc 
Ralph W F Hardy 
BioTechnca International. Inc 
David A Jackson 
E.l cu Pont de Nemours & Co 
John R NorcD 
Phillip! Petroleum Company 
Roger Salguat 
Caigene. Inc 
Huber J P Schoemaker 
Certocor 
Mark B ikale’sky 
Bwgen Inc 
Robert A Swanson 
Genentech. Inc 
Dr. William J. Gartland, Jr. 
Executive Secretary 
Recombinant DNA Advisory Committee 
National Institutes of Health 
12441 Parklawn Drive 
Suite 58 
Rockville, MD 20852 
Dear Dr. Gartland: 
These comments concerning a proposed amendment to Secti 
III-B-5 of the NIH Guidelines for Research Involving Recombi 
DNA Molecules are submitted on behalf of the Industrial 
Biotechnology Association (IBA). IBA is a trade association 
representing eighty companies many of whom are using recombi 
DNA technology to produce products in a variety of industria 
sectors . 
on 
nant 
nant 
1 
This amendment would alter the Guidelines by giving further 
advice to the Institutional Biosafety Committees (iBCs) regarding 
the containment for large scale fermentations of recombinant DNA 
organisms. At present the IBCs decide the appropriate containment 
for such applications. Guidance for physical containment is 
presented in Appendix K of the Guidelines. Unfortunately, 
Appendix K sets as a minimum level of containment Biosafety Level 
1-Large Scale (BL1-LS). For a great many fermentation applications 
this is too restrictive. Construction of a BL1-LS facility for 
enzyme and antibiotic production or brewing application would be 
highly capital intensive. Such a facility would not provide any 
incremental margin of safety over those in present use. Physical 
containment levels lower than BL1-LS may be appropriate. 
IBA supports the proposed amendment to Section III-B-5. We 
believe that this wording will improve the flexibility afforded to 
the IBCs in establishing containment for large scale fermentations. 
The biotechnology industry's experience has been that IBCs are 
conservative in setting physical containment levels. Since the 
present Guidelines do not provide advice on containment levels 
below BL1-LS, IBCs have been reluctant to set containment below 
this level. This proposed wording will offer the needed advice. 
Historically, the NIH Guidelines have been modified to take 
into account scientific knowledge related to risk assessment. When 
recombinant DNA techniques began to play an increasing role in the 
industrial production of fermentation products, the NIH-RAC 
addressed the associated issues. Questions about containment have 
been thoroughly examined. In addition, other groups also focused 
on industrial applications. The Organization for Economic 
Recombinant DNA Research, Volume 13 
[359] 
