Dr. William J. Gartland 
January 29, 1982 
Page 3 
discretion or impose other sanctions with respect to grants to 
that organization. The proposed simplification of the guidelines 
with respect to containment levels is desirable as is the 
elimination of prohibitions in Section (I-D) of the guidelines. 
Lilly also notes and appreciates the very thoughtful report 
submitted by Dr. Gottesman. Her recommendations contain several 
responsible suggestions for decreasing restrictions in the 
guidelines, which are not required for public health or laboratory 
safety. Although these merit careful consideration, we believe 
they could be improved - particularly with regard to minimizing 
the extensive bookkeeping and approval mechanisms that would 
still remain in place. 
The Federal Register notice contains comments relative to 
industrial applications of recombinant DMA technology. In this 
regard, it should be noted that the report of the Commission of 
the European Communities entitled "Hazards Involved in the 
Industrial Use of Micro-organisms" states: 
(p. 27) 
"In practice, an industrial fermentation process is 
extremely unlikely to become contaminated with a highly 
pathogenic microorganism, because the environment inside an 
industrial fermenter is so different from that of the human 
body that pathogenicity confers no advantage upon the 
organism. " 
(p. 36-38) 
"In discussion with firms involved in or intending 
exploitation of large scale biotechnology, we have been 
impressed by the well documented care that they have taken 
to ensure the wholesomeness of their products." "The 
imposition of standards that are not measurable by available 
techniques, too-frequent changing of standards without 
adequate warning to the industry concerned, and the blind 
application to biotechnological products of standards more 
stringent than those applied to the traditional materials 
that they seek to replace, can impose an unwarranted burden 
on an industry already beset by restrictions and ill-founded 
suspicion." 
It is Lilly's belief that industrial organizations involved in 
recombinant DNA technology have acted in a responsible manner. 
Such organizations have been and remain subject to a number of 
federal and state sanctions with respect to worker safety and 
