DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
FOOD AND DRUG ADMINISTRATION 
ROCKVILLE. MARYLAND 20857 
January 17, 1980 
Dr. Elizabeth Milewski 
Office of Recombinant DNA Activities 
Bldg. 31, Room 4A52 
Bethesda, Maryland 20205 
Dear Dr. Milewski: 
Enclosed are the Food and Drug Administration's comments on proposed 
Section VII of the Guidelines entitled "Physical Containment Guidelines 
for Large-Scale Uses of Organisms Containing Recombinant DNA Molecules." 
The comments were prepared by Dr. Armand Casola, who is a member of our 
Bureau of Drugs. We feel that incorporation of his recommendations 
(particularly his item #7) into the Guidelines will contribute 
significantly to the integrity of large-scale production systems. 
We would also like to request that we be kept informed of your response to 
Senator Stevenson’ s letter of November 21 with regard to the proposed 
legislation which would legally require the registration of all 
recombinant DNA work (research) which is not presently subject to the 
Guidelines. 
Sincerely yours. 
Timothy J. Henry, Fh.D. 
Staff Science Advisor (HFY-31) 
Office of Health Affairs 
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