Dr. Gartland 
February 3, 1984 
Page 2 
We would like to consider Dr. Talbot’s questions somewhat out of the 
order presented in the Federal Register notice. 
Q4. Should the NIH Guidelines be limited to strictly biomedical research ? 
HIMA believes that NIH’s and RAC’s proper perview includes all uses of 
R-DNA, not just biomedical research. This stance is based in part upon the 
broad expertise present in RAC and upon the similarity of elements in all 
R-DNA research. We feel that RAC is a unique resource which is looked to by 
all of the scientific community for guidance. We take "scientific community" 
to be a broad term which includes not only "biomedical" scientists but also 
those working on agricultural and other products as well as scientists employed 
by the private sector and working on a variety of projects. Given that defi- 
nition of scientific community and the supposition that many aspects of R-DNA 
research also carry across the "biomedical" boundary, we feel it would be a 
waste of talent to limit RAC’s review (and the applicability of the NIH Guide- 
lines) to strictly biomedical research. 
Ql. Should the NIH Guidelines be limited strictly to work done in the labor- 
atory ? 
HIMA believes that the NIH Guidelines need not be strictly limited to 
work in the "laboratory". There is and should be a continuum of oversight 
carried out by the company which begins in the laboratory setting and extends 
to the final utilization of a product. There is generally assumed to be a 
gradient of potential risk - if indeed any risk is involved - which decreases 
sharply between the laboratory and final production and this is especially true 
of biotechnology products. The determination of safety and efficacy of a 
final product is, of course, the duty of FDA, USDA, or EPA as appropriate. 
Questions of safety are taken up and settled , we would hope, within the labor- 
atory setting. We feel that the judgements on safety made at the laboratory 
level by RAC are the significant ones and that they can, with certain additional 
elements, be applied as well to 'environmental release . 
The involvement of other agencies, e.g., EPA in further certification 
or monitoring, would result in a needless rehash of questions already settled 
at the RAC level. In view of our preceeding statement advocating the appli- 
cability of the Guidelines to all R-DNA scientific endeavors, agricultural 
experiments which involve testing outside the traditional definitions of labor- 
atory would still be proper subjects for review by RAC. RAC has always been 
able to call upon the talents of outside experts for assistance when needed. 
Indeed, the non-voting federal agency members of RAC, especially those from 
USDA and EPA, could be expected to contribute significantly to the full RAC 
on questions involving agricultural and environmental modeling We feel that 
it would be a more viable and resouce conserving mechanism for USDA and EPA 
to assist RAC rather than to have the Federal agencies institute independent 
review programs. 
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