John F. Beary, m, N.D. 
SENIOR VICE PRESIDENT 
SCIENCE AND TECHNOLOGY 
Pharmaceutical 
Manufacturers 
Association 
May 23, 1988 
Dr. William J. Gartland 
Director, Office of Recombinant 
DNA Activities 
12441 Parklawn Drive 
Suite 58 
Rockville, MD 20852 
Subject: Recombinant DNA Research 
Proposed Actions Under Guidelines 
(Fed. Req., Vol. 53, pp 12752 - 12754, 
April 18, 1988) 
Dear Dr. Gartland: 
The Pharmaceutical Manufacturers Association ( PMA) is a 
voluntary non-profit trade association representing over 100 
companies engaged in research on, and the development, 
manufacturing and marketing of, prescription and ethically 
promoted drugs, biologicals and in vivo diagnostic products. 
Increasingly, these therapeutic and diagnostic products are 
created through biotechnology processes. We are, therefore, 
vitally interested in how biotechnology is addressed under 
national science policy and in regulatory decisions that affect 
research and development of biotechnology products. Accordingly, 
we welcome this opportunity to comment on proposed changes in NIH 
recombinant DNA ( rDNA ) research guidelines. 
We express support for both the Eli Lilly petition to 
conduct large scale experiments and production involving 
Cephalosporium acremonium strain LU4-79-6 with less than BL1-LS 
containment conditions and the Novo Laboratory petition for 
exemption from BL1-LS containment conditions for non-pathogenic 
and non-toxicogenic recombinant strains of host organisms having 
an extended history of safe industrial use. Both of these 
petitions are clearly in line with recommendations presented in 
the June 26, 1986 OSTP "Coordinated Framework for Regulation of 
Biotechnology" document and the OECD concept of Good Industrial 
Large Scale Practice. Furthermore, these proposals represent a 
logical extension of the August 24, 1987, revisions to the NIH 
Guidelines regarding large-scale containment for exempt organisms 
involving E. coli K-12, Saccharomyces cerevisiae, and Bacillus 
subtilis host-vector systems. 
[370] 
Recombinant DNA Research, Volume 13 
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