industry has been using these organisms, no untoward safety 
problems have arisen or been suggested in either small and 
large scale applications. More specifically, many decades 
of experience in the brewing industry with Saccharomyces 
cerevisiae indicate the safety of it as a host. Similar 
experience, using B. subtilis as a host in the detergent 
industry, exists. E. Coli K-12 has been used safely in 
medical research for 60 years and as a recombinant host in 
small and large-scale pharmaceutical applications for 10 
years . 
4. We support Dr. Young's proposed revisions in the 
guidelines and believe that they will enhance the 
competitive position of the U.S. biotechnology and 
pharmaceutical industries. We also believe that more 
explicit guidelines will enhance the strategic planning 
process at member companies and thus help them compete in 
the world's market place. 
5. As a means to further clarify the language in Appendices 
C-II, C-III, and C-IV to be consistent with Dr. Young's 
proposed revisions, we recommend that the following phrase 
be inserted into the existing second paragraph found on page 
45652 uner the paragraph beginning with: And Substitute : 
For large-scale [LS] fermentation experiments, and, [insert] 
where applicable subsequent manufacturing processes, [end insert] 
the appropriate physical containment conditions need be no 
greater than those for the host organism unmodified by 
recombinant DNA techniques . 
Lastly, the PMA appreciates the continuing review of the NIH 
guidelines. Experience has indicated that modifications of the 
guidelines are appropriate, not only as we gain more experience 
in the laboratory, but also as we gain more experience at the 
scale-up stage. PMA member firms are committed to continued 
voluntary compliance with reasonable guidelines for rDNA research 
and development. 
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