Recombinant DNA Advisory Committee - 10/16/90 
3. The proposed GLSPs are inadequate in that some of the 
provisions are vague and environmentally unwise. 
Dr. Goldburg said that she believed the adoption of the proposed 
amendment to Appendix K would erode RAC's credibility and 
replicate work already underway at EPA. She noted that steps had 
been taken this morning to remove the industrial emphasis of this 
proposed amendment but that it still appears to be an attempt by 
RAC to provide regulation for industry which is not a role of the 
RAC. 
Dr. Riley pointed out the fact that the NIH Guidelines were 
indeed not regulations and that in fact they explicitly contain 
language noting that they are not intended to conflict with 
regulations of other Government agencies. She pointed to 
Appendix K, and noted that Section K-ll-F explicitly states: 
"Discharges containing viable recombinant organisms 
should be handled in accordance with applicable 
governmental environmental regulations . " 
Dr. Post noted that although there was never any intention that 
the NIH Guidelines be construed by industry as regulatory, that 
many companies have voluntarily adhered to them as a matter of 
company policy. Indeed, they have evolved into a code of 
practice for the industry. 
Dr. Carmen asked how much large-scale research is done at 
academic institutions. Dr. Riley said she did not have any 
figures but noted that most large research campuses have large- 
scale fermentation facilities for the purpose of providing their 
investigators with materials for their individual use. Dr. 
McGarrity noted that there were a number of institutions with 
facilities that would exceed the 10-liter limit. He noted that 
many would probably be exempt since they are used for cell 
culture, and he was not sure how many were dealing with 
recombinant organisms. 
Dr. Foglesong pointed out that the NIH Guidelines originally 
designated "large-scale" as being greater than 10 liters, but 
that nowadays it is not uncommon for universities to have 14-15 
liter equipment which they are able to purchase from suppliers 
off the shelf. 
Dr. Elizabeth Milewski of EPA noted that they were in the process 
of developing regulations to address large-scale fermentation in 
industry. She suggested that since both EPA and NIH are part of 
the "Coordinated Framework," she asked that some provision be 
made for EPA and NIH to work together under the rubric of the 
"Coordinated Framework" to discuss this particular proposal to 
[344] 
Recombinant DNA Research, Volume 14 
