9 
facilities in Ireland. Schering-Plough has made a commitment to the Irish 
government that any production in that country utilizing recombinant ENA 
technology will be conducted in accordance with the NIH Guidelines. 
Dr. Waitz said industry has not always been supportive of the regulatory 
direction followed in the early years of biotechnology. In more recent years, 
however, industry has observed the development of the NIH Guidelines and has 
grown increasingly confident that the Guidelines reflect prudent practices and 
controls. Ef. Waitz said that although Schering-Plough Corporation has generally 
found the guidelines reasonable and workable, sene modifications might be made. 
He then offered several proposals to modify the NIH Guidelines for Research 
Involving Recombinant DNA Molecules, the Recommendations for Physical Contain- 
ment for Large-Scale Uses of Viable Organisms Containing Recombinant ENA 
Molecules, and NIH-industry interaction. 
Dr. Waitz' s first proposal would amend Section III-B-5 of the Guidelines for 
Research Involving Recombinant D1& Molecules (47 FR 38048). Section III-B-5 
reads as follows: 
"111-6-5. Experiments Involving More than 10 Liters of Culture. 
Ihe appropriate containment will be decided by the IBC. Vtfiere 
appropriate , the large-scale containment recommendations of the 
NIH should be used (45 FR 24968). 
Under this specification most large-scale procedures must be reviewed by the 
Institutional Biosafety Camiittee (IBC) prior to initiation of the experiments. 
Dr. Waitz said Schering-Plough Corporation supports the concept of IBC review 
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