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firms to sutmit reconmendations or suggestions for nodifying the "Physical 
Contairment Hecoiurendations for Large-Scale Uses of Organisms Containing 
Recombinant DNf^ Molecules." ( Federal Register 45; 24968 (1980).) 
Presentation of the Industrial Biotechnology Associaticai 
Hr. McKinney introduced Et. Robert Fildes, vice-president of the Industrial 
Biotechnology Association (IBA) and president of Biogen, Inc. Dr. Fildes said 
the IBA is an international trade association of two dozen conpanies actively 
engaged in developing commercial products through biotechnology. 
EC. Fildes said conpliance with the NIH Guidelines has become acc^ted industry 
practice. In addition the industry conplies with the other extensive regu- 
lations to vhich it is subject. Currently government regulations governing 
biotechnology (other than the NIH Guidelines e.g. , those of the EPA, FEA, 
USDA) are comprehensive; industry, however, believes it can work under these 
regulations and safely produce effective products. Additional regulation would 
contribute little to public health and safety and would be duplicati\« and cum- 
bersome from industry's point of view. Accordingly, the IBA believes that the 
present regulatory balance between the public and industry is proper, and 
should not be altered significantly. 
The industry is beginning the transition from bench scale experiments to pilot 
plant operations. As part of that transition, industry has put into effect 
numerous practices vhich reflect ccxicem with worker safety and the environ- 
ment. Examples of industry practices among IBA members include; 
o Use of physical and biological containment based on the NIH 
Guidelines; 
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