36 
which would automatically become effective after 30 days. Press 
cautioned that : 
The notion that all paths of investigation must be identified and approved in 
advance flies in the face of the scientific method, in which the results of one 
step in the process guide the next decision point. ... A cumbersome review of 
experimental protocols and the many contingent experiments may prove counter- 
productive. 
Similarly, witnesses generally opposed provisions for seizure of re- 
search materials, high fines, or criminal penalties for violations. 
Several pointed out that civil or criminal fines would impose a greater 
hardship on academic than on industrial research scientists. 
A number of witnesses called for a scale of penalties, each appropri- 
ate to a particular offense. When asked what action should be taken in 
the event of a violation of the containment standards, Oliver Smithies 
of the University of Wisconsin said that it would be appropriate to 
revoke the license for conduct of a prohibited experiment or use of an 
untested organism. A less serious offense might merit closing of the 
laboratory for a period of time equal to the duration of the violation. 
With reference to the behavior <?f individual researchers, David New- 
burger suggested that : 
. . . the Federal Government through the self -regulatory committees and in 
■consultation with them should ultimately have the power to control the conduct 
of individuals in the laboratories . . . for example, by having the power to bar a 
person from working in a laboratory. . . . 
In addition to requiring the submission of information on recombi- 
nant DXA activities, the Federal Government should have authority 
to inspect laboratories, according to spokesmen for the pharmaceutical 
manufacturers and some academic scientists. Levin suggested a sam- 
pling of facilities at all four containment levels, while Frank Young 
of the University of Rochester preferred that inspections be limited 
to the higher containment laboratories. Jonathan King noted the pres- 
ent difficulty of identifying the biological material used in recombin- 
ant DMA work and said that NIH should invest in developing proce- 
dures for such monitoring. He also regarded it as essential to monitor 
laboratory workers’ health. In the absence of such records and suitable 
comparative data, he argued it would be impossible to say what are 
the health effects of recombinant DNA materials. 
Whatever certification, registration, and inspection system is estab- 
lished presents the further problem of public disclosure of normally 
confidential information. The problem characterizes all business regu- 
lation, but it is unusually troublesome when the subject of regulation 
is basic scientific research with an exceedingly promising technology. 
Joseph Keyes described the two concerns of the academic research sci- 
entist — first, that he may be deprived of the opportunity to exploit his 
ideas by premature disclosure of a research application or information 
submitted in compliance with regulatory requirements, and second, 
that the opportunity to patent an invention and license its development 
may be lost by premature publication. In the United States, a patent 
must be applied for within 1 year of publication; in other countries 
there is no grace period. As a result of the recent Supreme Court deci- 
sion in Parker v. Bergy, 46 U.S.L.W. 3788 (U.S., June 26, 1978), the 
patentability of purified or genetically manipulated living organisms 
[Appendix B — 295] 
