progenitors, is non-pathogenic and that experiments and 
production under conditions less restrictive than BL1-LS were 
consistent with the recently approved amendment to the NIH 
Guidelines . 
Dr. Foglesong cited the following: 
1. The non-recombinant progenitors of this have 
derived from a common ancestral strain, ATCC 
11550, and have been used safely in industry 
without any special containment for over 25 
years . 
2. The difference between the recombinant strain 
and its non-recombinant progenitor has been 
well characterized and consists of the 
insertion of an extra copy of a key C . 
acremonium antibiotic biosynthetic gene along 
with well characterized heterologous vector 
DNA back into the non-recombinant derivative 
of ATCC 11550. 
3. Several factors exist to address Dr. 
McKinney's concerns about biological 
containment: the gene and heterologous vector 
DNA are stably integrated into the host 
chromosome; C. acremonium is an asexual 
fungus lacking any system for genetic change; 
C. acremonium contains no transducing 
viruses; and, the host organisms are at a 
significant competitive disadvantage with 
respect to the original wide type organism, 
or for that matter Streptomyces present in 
soil, and in experiments performed could not 
survive in soil after 4 days. 
Dr. Foglesong said investigators at Lilly have experimented with 
the recombinant strain for 12 months under BL1 conditions in the 
laboratory and for 8 months at BL1-LS in a 150 liter pilot plant 
study. During this time no observation was made of any 
unexpected changes in the fundamental characteristics of the C. 
acremonium host. He said it is believed that the recombinant 
strain can be characterized as a product of self -cloning and 
although the vector contains heterologous DNA it is Lilly's 
belief that the DNA does not change the non-pathogenic character 
of the host and does not present a significant risk to human 
health or to the environment. 
Dr. McKinney said he appreciated the information on the non- 
recovery from soil after 4 days and suggested the RAC consider 
approving this petition pending Lilly's satisfactory explanation 
Recombinant DNA Research, Volume 13 
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