9 
Mr. Mitchell said he had attended a panel meeting of the Califismia legisla- 
ture's Canmittee on Health on December 14, 1981. Pie said these legislators, 
few of v*)om have a scientific background, spoke in terms of public percep- 
tions. Pie questioned how many of those legislators would understand the 
scientific arguments or atterpt to ccmpcehend technical presentations. 
Mr. Mitchell said he supported the Decanber 7 proposal as it maintains 
the mandatory nature of the Guidelines and the requirement for IBCs. 
Dr. Pedoroff said she strongly supported the Decanber 7 proposal and 
urged that a mechanism for further simplification be introduced. 
Dr. Saginor said that the recombinant ENA issue could easily become a 
political football; the Guidelines have restrained politicians from using 
this as an issue. Pfe added that the I^AC as a central committee providing 
a forum for discussion is necessary. Pfe supported the December 7, 1981, 
proposal. 
Dr. Irving Johnson of Eli Lilly and Company said Eli Lilly had commented 
favorably an both the December 4 and the December 7 proposals, although he 
had reservations daout both proposals. Pfe said the December 4 proposal 
provides no "trackabilitY". "nie December 7 proposal, vhile it simplifies 
the Guidelines, perpetuates mnecessary bookkeeping. Pfe said that Eli 
Lilly and Company recommends itandatory retention of IBCs viiich should be 
required to report problems to the I?AC. 
Dr. Johnscxi pointed out that representatives of regulatory agencies are on 
the Interagency Recombinant ENA Committee and have liaison representatives 
to the PVVC. Ibese representatives are there to monitor events and suggest 
^propriate action to their agencies. For a ccmpary involved in interstate 
commerce such as Eli Lilly and Company, these agencies represent regulations 
which are mandatory and not voluntary. 
Dr. Johnson said he had attended the November 1981 hearings of the California 
Legislature's Committee cxi Pfealth and had detected little concern over risk 
at that hearing. Concerns were expressed, however, over moral and ethical 
problems. Dr. Jenson exparessed concern about again raising the issue of 
large-scale work and cited the safety of large-scale equipment. He proposed 
amending the December 4, 1981, propxssal to require retention of IBCs. 
Dr. McGarrity said that he has concluded that recombinant ENA research 
presents no hazards beyond those normally associated with microbiological 
research. This is not to say tPiere are no problems in other areas of 
biomedical research; however, these hazards have been adequately handled. 
Pfe stated that it is time to stop the discriminatory treatment of recom- 
binant I»JA research. Pfe favored tlie December 4, 1981, proposal with some 
modifications. 
[ 338 ] 
