Recombinant DNA Advisory Committee - 7/31/90 
Dr. Riley said that there was no document provided with the 
submission detailing exactly what were the provisions of "good 
industrial large-scale practices." She said they did supply a 
graphic illustration comparing such practices to biological 
safety levels for dealing with biological hazards, and they 
showed the same escalation in precautions as the hazards became 
greater. 
Dr. Riley said she felt the rationale for this submission was 
that the IBA and PMA thought that there was no reason to have 
increased precautions in dealing with large-scale production, 
simply because the technique used recombinant DNA. This request 
reflected once again the product versus process issue that the 
RAC has dealt with many times in the past. 
Dr. Riley noted that this change would affect both industrial 
organizations and research using volumes greater than 10 liters. 
She said she had no idea how this may impact an academic 
situation or non-industrial research environment. 
Dr. McGarrity called on Dr. Copmann of the PMA for comment. He 
said he felt the proposal was well presented by Dr. Riley. 
Dr. Wivel asked Dr. Riley if it would be agreeable to have the 
Subcommittee on Modification of the NIH Guidelines review this 
before the October meeting of the RAC. Dr. Riley said she 
thought that was a good idea and noted that the actual 
stipulations of "good industrial practices" could be supplied to 
allow for more cogent discussion of the proposal. 
Dr. Atlas asked whether, if by adopting this modification 
allowing for "good industrial practices," a facility performing 
such experiments would be termed a "contained facility" despite 
the fact there are no provisions in the proposal addressing non- 
release to the environment. He noted that there was a bill in a 
congressional subcommittee which seeks to regulate all 
deliberately modified organisms released to the environment, but 
this would exclude from its permit process those facilities 
considered under the NIH Guidelines to be "contained facilities." 
Dr. Riley said she did not believe such a facility would be 
deemed a "contained facility" due to this proposed change in 
Appendix K, and she asked if the use of the term "modified 
organisms" would include mutated organisms. Dr. Atlas said that 
the current language of the bill would include mutated organisms 
including deletion mutants. 
Dr. Riley said she welcomed input on this proposal from others. 
She felt that the bill before the Congress was not particularly 
rational and would have a major impact on the industry. Dr. 
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