-5- 
5. Proposed Model Containment Review Process 
A review process should be established which would be able to determine 
whether a given laboratory has the appropriate containment facilities for a 
given type of experiment. As far as possible, the biohazard review process 
should not lengthen the time required for review of research proposals. The 
specific form of the review procedure in different countries for different 
scientific and industrial laboratories must depend on local circumstances. 
The following proposal is, therefore, presented as a model. The model is 
designed for universities in the United States but would have to be modified 
for other situations. 
Each university or research institution should have a committee 
empowered and trained to grade the physical containment facilities of its 
laboratories (e.g., low, moderate or high according to established guidelines). 
The local committee would provide the laboratory head with a statement 
certifying the containment rating of the laboratory (subject to periodic 
reevaluation). 
When an individual applies to an agency for funds to support work on 
recom.bin.ant DNA molecules, the certificate of containment rating would be 
appended. The group reviewing the grant would then determine whether 
the certified level of containment matched whatever biohazard might result 
from the proposed work. The biological barriers incorporated in the 
experiment, the magnitude of proposed growth of bacteria, the type of DNA 
to be cloned, etc., would all enter into the decision. If the reviewing group 
is satisfied, the grant would be processed for scientific merit in the usual 
fashion. If a question arises concerning the appropriateness of the 
certified containment level, the NIH Advisory Committee on Recombinant 
DNA Molecules or some other body would be asked for an opinion or ruling. 
This procedure would not guarantee that all experiments would be 
performed under the required containment conditions but if the investigators 
have reasonable good will, the system would generate widespread 
compliance. 
6. New Knowledge 
This document represents our best assessment of the potential bio- 
hazards in the light of current knowledge. To improve this assessment, it 
will be important to have answers to the following questions. 
(1) Are eukaryotic genes or viruses expressed in prokaryotic hosts 
and, if so, can they modify the biohazard potential of these cells? 
(2) Can free DNA molecules infect animals or plants? 
(3) Can prokaryote-eukaryote recombinant DNA molecules, either 
free or encapsulated as phage particles infect animal or plant cells and be 
expressed there? 
(4) Can mammalian cells in culture be genetically transformed by 
fr ee homologous or heterologous DNA? 
(5) Can hybrid animal virus DNA or virus-plasmid hybrids cause 
tumors in animals? 
(6) Can methods be developed to monitor effectively the escape and 
dissemination of cloning vehicles? 
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