DEPARTMENT OF HEALTH & HUMAN SERVICES 
Public Health Service 
Food and Drug Administration 
Rockville MD 20857 
'■W 2 3 
William J. Gartland, Jr., Ph.D. 
Director, Office of Recombinant 
DMA Activities 
12441 Park lawn Drive 
Suite 58 
Rockville, MD 20852 
Dear Bill: 
The Food and Drug Administration wishes to make the following 
comments on proposals published in the Federal Register to be 
discussed at the approaching meeting of the RAC. 
I. Proposed Amendment of Section I-C. 
We find the proposed wording to be rather tortured and 
ambiguous . The meaning of the term, " . . . is a direct 
extension of the development process," is obscure; usually, 
"development" is considered to emanate from research, rather 
than the opposite. Moreover, singling out "deliberate release" 
and "testing in himans of materials containing recombinant DNA" 
seems arbitrary and unnecessary. The FDA is responsible for 
oversight of drugs and biologies exported for testing in 
humans . We oppose the proposed change . 
III. Proposed Amendment of Section III-B-5. 
We strongly support the sense of the proposal; namely, that 
generic criteria can and should be specified that permit 
large-scale cultivation of recombinant DNA -containing organisms 
at physical containment conditions "no greater than those for 
the host organism unmodified by recombinant DNA techniques." 
In fact, this concept was a cornerstone of the OECD 
(Organization for Economic Cooperation and Development) 
docunent, "Recombinant ENA Safety Considerations, 1 published in 
1986. In the OECD document, this class of organisms was 
designated "Good Industrial Large-Scale Practice (GILSP) ." The 
criteria for GILSP are listed in that document's Appendix F 
(attached) . 
For the sake of consistency and harmony, we would favor 
proposed amendment of section III-B-5, but with criteria closer 
to those specified in the OECD document. 
Recombinant DNA Research, Volume 13 
[367] 
