18 
Dr. Gottesman said she had included the reference to cell fusion in point II-(2) 
as the Federal Register announcement preposed regulation of cell fusion experiments 
at the laboratory level. She questioned Vvhether any valid reason to regulate 
these procedures existed. She asked whether the working group should comment 
specifically on the proposal to regulate cell fusion experiments under the 
oversight scheme for "biotechnology." 
Dr. Lardy felt cell fusion experiments cure research and should not be regulated 
under the scheme proposed in the December 31, 1984, Federal Register . He suggested 
NIH indicate it will take uider advisement the suggestion that cell fusion 
experiments are research activities which should be overseen by the NIH. 
Dr . Gartland pointed out that the Federal Register announcement indicates the 
agencies will oversee cell fusion experiments. He said the NIH might be required 
to regulate cell fusion experiments inder the scheme preposed in the December 31, 
1984, Federal Register announcement. 
Dr. Landy said he objected to the rather cavalier fashion in which the December 31, 
1984, Federal Register announcement suggests cell fusion experiments should be 
regulated. He felt there should have been greater epport unity for pibiic dis- 
cussion. 
Dr. Gottesman suggested the working group could request further discussion of 
the issue before any proposal to regulate cell fusion experiments is implemented. 
The working group agreed an explicit reference to the status of cell fusion 
experiments under the Federal Register announcement should be made in point 
II-(2 ) . 
Dr. Clones felt the first two sentences point II-(2) which deal with the status 
of laboratory research are redundant as these ideas were expressed elsewhere 
in the working group response. He suggested these two sentences be deleted. 
The working group agreed. 
The working group agreed to the following language for point II-( 2 ) : 
"Is it proposed that cell fusion research at the laboratory level be subject 
to review? We strongly recommend that no such expansion of oversight of 
laboratory research take place without extensive discussion. Would any of 
the broad definitions of biotechnology preposed by the EPA apply to labora- 
tory research?" 
Mr. Mitchell called the attention of the working group to point II-(3 ) which 
discusses the flexibility of the oversight structure and the status of the NIH 
Guidelines aider the proposed structure. 
Mr. Mitchell asked Mr. Walsh whether the Cabinet Council Working Group had 
discussed the effectiveness of the NIH Guidelines or the effect of the Federal 
Register proposal on the NIH Guidelines. 
[348j 
