GIN/I AG 
Genetic Manipulation Advisory Group 
at Medical Research Council 
20 Park Crescent, London W1 IM 4AL 
telephone 01 -636 5422 
reference S604/26 
29 January 1980 
Dear Bill, 
Thank you very much for your letter of the 20 December and the draft NIH guide- 
lines relating to large-scale use of genetically manipulated organisms. 
The present position in fre UK is that GMAG has only given preliminary advice on 
one 'large-scale' proposal. The Group have received a preliminary proposal for 
'large-scale' work from a Pharmaceutical Company and the Group has had exploratory 
discussions with them. However, GMAG as you know has decided to consider 'large- 
scale' work under a different procedure compared to the NIH. Until the plant is 
complete the Group will not give their formal advice. At present the Company has 
not constructed the plant although it is fair to say that they have provided 
information on the biological systems, plant design and safety procedures etc. 
that they intend to use. GMAG has taken the view that it will not categorise 
'large-scale' work along the physical containment requirements which have been 
recommended for laboratories. It will review each 'large-scale' application on 
a case by case basis and on the information provided regarding the physical, 
biological, safety and operating procedures it will advise on whether the Group 
consider the work can be safely carried out. The Group has, therefore, not made 
any statement to date relating to the physical containment for such work. 
With regard to the draft guidelines I am sure that GMAG would expect that most 
of the recommendations in your draft guidelines are incorporated into the 
operating procedures for work carried out in the UK with perhaps one or two 
exceptions. For example: 
i) Vll-B-2-a - With the exception of the laboratory aspects of the work GMAG 
would not necessarily insist on a HEPA filtered system. . If evidence was 
provided that some other form of sterilisation (such as steam or ignition 
of gases) was effective then the alternative would be accepted. This also 
applies to Vll-C-3-k. 
ii) Vll-C-3-j - In an industrial environment such requirements may well prove 
very difficult to implement in practice. The necessity to control and the 
extent of any control of the ventilation system must very much depend on 
the particular organism etc. For this reason the GMAG has once again 
decided not to codify the physical containment necessary for large-scale 
work but to adopt a much more flexible approach. 
The GMAG also intend to place emphasis on a site visit to assess the overall 
safety of the operation. 
/ 
[ 267 ] 
