2 
looks to OSHA and NIOSH to develop regulatory programs. There is perhaps 
not enough information for OSHA to draft regulations for the recombinant 
DNA industry today, but steps should be taken to get there. NIOSH and 
OSHA should jointly make visits to plants to evaluate the industry and 
come up with criteria to protect workers. These might include environmental 
monitoring, medical surveillance, and perhaps most important, training 
and education. The AFL-CIO is willing to work with OSHA, NIOSH, NIH, 
and any other agency, to move toward measures to protect workers. 
Dr. John Adams and Dr. Ann Skalka 
Dr. Omenn next called on Dr. John Adams, Vice-President of the Pharmaceutical 
Manufacturers Association. He was accompanied by Dr. Ann Skalka of the Roche 
Institute of Molecular Biology, who is chairperson of the Working Group on 
Risk Assessment of the Committee on Genetic Experimentation (COGENE) of the 
International Council of Scientific Unions. (Dr. Adams' prepared statement 
and the first and second reports of the COGENE Working Group are appended as 
Attachments D, E and F). 
Dr. Adams said that there is nothing novel or unique in the routine 
procedures used in recombinant DNA research and production that would suggest 
the need for extraordinary precautions. The safety record of industry in 
production of substances by fermentation has been outstanding. By comparison 
to other industrial processes, including the production of potent chemicals 
and biological products, the risk to workers and to the public of industrial 
recombinant DNA technology is probably minimal. 
Following Dr. Adams' statement. Dr. Barkley asked whether perhaps new, 
small, industrial concerns which have not had the experience of PMA member 
firms, should be an area of special concern for the Subcommittee. Dr. Adams 
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