MEMORANDUM 
TO : FOR THE RECORD 
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 
PU3UC HEALTH SERVICE 
NATIONAL IX IIWIU OF HEALTH 
DATE: March 6 , 1980 
Page 39 of Attachment H 
FROM : Director 
Division of Safety, ORS 
SUBJECT: Sice Visit, Eli Lilly Co., Large Scale Recombinant DNA Production Facility 
On January 28, 1980 the Eli Lilly Co. , Indianapolis, Indiana was visited for 
the purpose of reviewing the facilities, equipment and operations relative to 
the large scale production of organisms containing recombinant DNA molecules. 
In addition, discussions were held relative to the draft guidelines governing 
the large scale production of organisms containing recombinant DNA molecules. 
The visit was arranged by Dr. Barkley at the request of Dr. Fredrickson. 
Dr. Barkley was accompained by two members from the RAC, Dr. Leroy Walters 
and Mr. Ray Thornton. Dr. Robert W. McKinney, Consultant, Enviro Control, 
Inc. also participated as a member of the site visit team. 
The group representing Eli Lilly was headed by Dr. I. S. Johnson and also 
included Dr. Lawrence E. Day, Dr. J. Paul Burnett, Dr. David W. Dennen, 
Dr. Richard H. Baltz, Mr. Max Marsh, and Mr. William B. Young. 
Briefing 
Eli Lilly has an Institutional Biosafety Committee (IBC) and a Recombinant 
DNA Protocol Safety Committee. Representation on the IBC includes both 
company personnel and persons from the community. The Biological Safety 
Officer is a member of the IBC. It is to be noted that duties of the Safety 
Officer are collateral to his normally assigned duties. The IBC meets the 
second Monday of each month and is chaired by Dr. I. S. Johnson. 
The Recombinant DNA Protocol Review Subcommittee is comprised of company 
personnel representing the research staff, corporate safety, and technicians. 
It Is augmented, as required, with other personnel. The Subcommittee meets 
On Call and is chaired by Mr. M. M. Marsh. 
Protocols involving studies with organisms containing recombinant DNA 
molecules are reviewed by the Subcommittee prior to action by the IBC. 
Company policy requires chat a protocol be submitted for new programs or 
when there are substantive changes effected in an existing approved program. 
The Biological Safety Officer inspects and certifies laboratories to be 
utilized for the conduct of work involving organisms containing recombinant 
DNA molecules. The IBC monitors these laboratories by semi-annual inspec- 
tions . 
[ 475 ] 
