5 
its intended purpose. The equipment shall: 
VII-B-2-b- ( 1 ) . Be designed, fabricated, and installed in a manner which 
provides for the containment of materials used in, or resulting from, the 
propagation of organisms containing recombinant DNA molecules. Containment 
refers to the prevention of the release of materials to the environment 
during periods when the unit contains viable organisms. 
VII-B-2-b- (2) . Be designed, fabricated, and installed in a manner which 
facilitates observation during operation to assure the integrity of contain- 
ment . 
VII-B-2-b- (3) . Be designed and fabricated in a manner which provides 
for sterilization of surfaces exposed to organisms containing recombinant 
DNA molecules prior to exposure of these surfaces to the environment. 
VII-B-2-b- (4) . Be designed, fabricated, and installed in a manner which 
facilitates disassembly, cleaning, and maintenance to assure integrity of 
the containment features of the unit. 
VII-B-2-b- (5) . Have all connected utility services protected against 
contamination. 
VII-B-2-b- (6) . Be tested for integrity of the containment features 
using a non-debilitated strain of the species of the host organism to be 
employed in production. Testing shall be accomplished prior to the initial 
production of organisms containing recombinant DNA molecules, and following 
modification or replacement of essential containment features. Procedures 
and methods used in the testing shall be appropriate for the equipment 
design and for recovery and demonstration of the test organism. 
VII-B-2-b-(7) . Be permanently identified. This identification shall 
be used in all records reflecting testing, operation and maintenance and 
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