Attachment V - page 2 
2 
b. A statement of the rationale for wishing to exceed the 10-liter 
limit. 
c. A specification of the total volume of the fermenter to be used. 
d. Evidence that the recombinant DNAs to be employed in the research 
have been rigorously characterized and are free of harmful 
sequences. 
e. A description of the applicant's laboratory practices, containment 
equipment, and facilities relevant to the containment of large 
volumes of culture. 
f. Evidence of the applicant's or applicant institution's previous 
experience in handling large volumes of culture. Applicants 
should exhibit knowledge of state-of-the-art procedures for 
working with large volumes of microorganisms. 
g. A description of procedures to be employed for the inactivation 
and disposal of large volumes of culture. 
h. A description of procedures for containing and inactivating 
accidental spills, should they occur. 
2. Each request submitted to ORE& shall be referred to a working group 
of the NIH Recombinant DNA Advisory Committee for review. 
3. Following review and approval by the working group, each request 
shall be submitted to the entire Recombinant DNA Advisory Ccnmittee 
for review. 
4. Following review and approval by the RAC, each request shall be 
submitted to the Director, NIH, for final review. 
5. Applications for large-scale experiments which are submitted by 
institutions not receiving NIH funds for recombinant DNA research 
shall be kept confidential (provided the institutions so desire) in 
accordance with the provisions of the NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
These procedures may be refined or revised on the basis of discussion 
and action by the NIH Reccmb inant DNA Advisory Committee. 
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