2 
3. The fact that the British Genetic Manipulation Advisory Group (GMAG) 
is to consider in late September a proposal from the Confederation of British 
Industry (CBI) to weaken the British controls for large-scale work should 
not be used to justify the Lilly proposal. By using a hypothetical decision 
in Britain to argue for a decision by the RAC to weaken controls in the U.S., 
Lilly is encouraging the ’two decision-making processes to move in a spiral, 
the end result of which could be seriously weakened controls in both 
countries. For a decision by the RAC to weaken oversight of industrial pro- 
cesses will place additional pressure on Britain and other countries to do 
likewise, lest they be left behind in the race for technological dominance 
in the genetic engineering field. (0 
In any case, it is not at all clear that GMAG will take the "positive action" 
which Dr. Johnson anticipates. My understanding is that there is no significant 
support for the CBI proposal, and strong criticism from some members of GMAG, 
particularly those who represent trade unions. So it seems unlikely that the 
proposal will be implemented, (i.) 
The RAC should also be aware that even if the CBI proposal were approved, 
large-scale work in Britain would still remain under regulation by the Health 
and Safety Executive (HSE) . The CBI is not proposing that the HSE requirement 
that large-scale work be registered with the agency be removed. However, if 
the Lilly proposal is approved, no specific controls would apply in this 
country, and in particular, there would be no registration requirement. Con- 
sequently, it would be difficult to collect data on the extent and location 
of large-scale industrial processes, let alone exert any form of oversight. 
4. No comparative studies of the risks of small- and large-scale work have 
been carried out, and any statements comparing these risks are developed 
against a background of very wide uncertainty. However, at least one study 
of the risks of large-scale work has been completed. This is the report of 
Dr. K.Sargeant and Dr. C.G.T. Evans of the Microbiological Research Establishment, 
Porton, U.K. commissioned by the Commission of European Communities and 
published in 1979.(3)The report does not play up the risks of large-scale 
work involving genetically manipulated organisms. It has been described as 
a "cool, non-scaremongering assessment. 'YfjNevertheless, it points to several 
areas of concern, including the following: 
a) "The new features presented by an expanding biotechnology today are the 
very large scale on which some micro-organisms are about to be grown for 
the first time, the very large number of people who will encounter these 
newly available micro-organisms or their products, and. the possibility that 
the environment might be altered by their use or inadvertent release." (p.22) 
b) Some of the special hazards of biotechnology lest on the possibility that 
the organisms thought to be in the fermenter are not what they are thought 
to be, or are not behaving in the way assumed. First, there may be phenotypic 
changes in whd.ch organisms adapt to changes in their environment with changes 
in their biochemical processes. Such changes might affect the virulence of 
organisms thought to be harmless. The authors point to the example of 
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