MINUTES OF MEETING - December 6-7 
23 
XIV. PROPOSED EXPIRATION OF SUPPLEMENT FOR VOLUNTARY COMPLIANCE 
At the beginning of this discussion. Dr. Krimsky said that he 
would like to make available to the working group evaluating 
the FMD experiments documents reporting on an outbreak of Foot 
and Mouth Disease on Plum Island in 1978 (Attachment TV). 
Dr. Krimsky said that this proposal by Dr. Novick (tabs 773A and 
774/2) suggests that a trial period with an expiration date of 
June 1, 1980, be mandated for the voluntary compliance program 
for non-federally funded research. He said the RAC is saddled 
with review functions under the voluntary compliance program 
despite its recommendation that a mandatory program is needed. 
He pointed out that it is impossible to know which firms are 
carrying out recombinant DNA work in the absence of a mandatory 
registration process. He said the notion of voluntary compliance 
raises difficult questions: (1) Hew would a violation be reported 
and to whom? (2) Can the biosafety officer of a firm or its 
biosafety committee act independently? (3) Is not the greater 
hegemony of commercial over academic institutions a factor in 
the potential effectiveness of its biosafety committee? (4) If 
a firm openly violated the Guidelines, hew should or would NIH 
respond? (5) What sanctions are available to restrain firms 
that flaunt the Guidelines or good microbiological practices? 
Dr. Krimsky stated that each of these queries represents a 
serious defect in a voluntary compliance scheme. He said the 
program of voluntary compliance could engender a sense of 
false confidence in the public at large. He called the Com- 
mittee's attention to tab 800, a letter from Senator Adlai 
Stevenson which concludes with a very strong statement that 
voluntary registration provides no assurance that all firms will 
register their research nor that any single firm will register 
all of its work. 
Dr. Krimsky said that in the states and local communities that 
debated the issues, voluntary compliance by industry was not 
considered a viable option. He said that if one believes that 
there are any potentially real hazards either due to the tech- 
niques themselves or because the technique will increase 
substantially industry's use of biological agents, then one must 
take seriously the issue of regulation. Dr. Krimsky said he 
opposes Dr. Novick' s motion because it presupposes that it can 
be ascertained whether a voluntary program of compliance is a 
success. Dr. Krimsky proposed the following alternative motion: 
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