Dr. William Gartland 
3 
We propose that for any novel use of recombinant DNA techniques for which 
no risk assessment studies have been carried out, initial physical containment 
should be set at no less than P3. Containment levels should be changed crly after 
comprehensive risk assessment studies have been carried out and agreement reached 
as to the significance of the empiricical data. 
3 . Decisions on large-scale processes 
a) All decisions on large-scale processes should be made at the formal meetings 
of the RAC. 
b) A full risk assessment of the process in question should take place before 
consideration of an increase in scale. This should include i) assessment of the 
safety of the organisms in use; ii) consideration of possible contamination of 
the large volumes in question;, iii) re-examination of the effectiveness of physical 
containment levels developed for small-scale experiments when applied to large 
volumes; iv) consideration of possible escape routes provided by a large volume. 
c) All facilities involved in large-scale processes should be required to obtain 
a license from some authority .* The licensing authority should have responsibility 
for establishing mandatory training and medical surveillance programs, and for 
site visits. 
Til. Comments on proposed actions under the guidelines published in the Federal 
Register, April 13, 1979 
1. Proposed exemption under I-E-5 for experiments involving EKl and EK2 host-vector 
systems (item // 6) 
We are strongly opposed to this irresponsible and short-sighted proposal. It would 
make a mockery of the attempt to develop rational containment policies for 
recombinant DNA work. This proposal also seriously undermines the NTH’s own proposed 
program of risk assessment ( Federal Register , April 2, 1979). If the NIH is seriously 
considering pursuing further risk assessment experiments on E.coli K-12 systems, 
a decision to dismantle precautions for those systems before the results are in 
is unjustified and irrational. 
2. Proposed exemption under I-E-5 for cloning in tissue culture cells (// 7 ) 
We are strongly opposed to this proposal. Recent findings have shown clearly 
that many cells contain genetic sequences relating to the transforming genes of 
tumor viruses which may be latent or cryptic in the cell. In addition, the critical 
sequences in transforming viruses may represent a very small fraction of the 
genome. Therefore, the introduction of foreign DNAs linked to viral sequences 
(even if only one-fourth of the genome of the virus) into tissue culture cells 
may still provide the possibility of generating within that cell a source of 
genetic variation for endogenous or exogenous viruses. 
*E.g. EPA, OSHA, or CDC. 
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