SEPTEMBER 6-7 - MINLTTES OF MEETING 
14 
there could be any misunderstanding about the strain K-12, since the 
Guidelines were constructed around K-12. He said that the motion 
refers to the original K-12 strain isolated at Stanford University. 
Dr. Maas expressed some concern about Dr. Levy's experiments. He said 
that the results may depend on the kinds of plasmids used in the 
experiment. 
During discussion on the kinds of experiments that would be exempted, 
Dr. Gottesrrvan emphasized that scale-up to over 10 liters would not be 
prohibited. Only the first five prohibitions override all the exemptions. 
Dr. Novick said that he was not satisfied with the wording of his proposed 
amendment, and withdrew the amendment. 
Dr. Baltimore said that the proposed exemption would save investigators 
a lot of time. 
Dr. Walters said that if biologically active polypeptides are an area of 
concern, the RAC should consider including a prohibition on scale-up 
with the exemption. Mr. Thornton then proposed an amendment to Dr. Williams' 
motion to add the words "subject to the prohibitions of I-D-l through 
I-D-6" after the word "Guidelines." The RAC accepted Mr. Thornton's 
amendment by a vote of 13 to 0, with 1 abstention. 
Dr. Goldstein said that he would like additional discussion of Dr. Novick's 
, proposed amendment which had been withdrawn. He said that he was also 
concerned about the issue of active polypeptides. Dr. Baltimore said 
; that investigators do not do experiments that are a priori harmful. He 
said that you have to depend on the good will of the scientific community, 
and noted that there are no rules for the handling of pathogens. Dr. Rowe 
said that the proposed amendment of Dr . Novick would be difficult to 
implement because it would create a very difficult dividing line between 
what is exempt and what is not exempt. He said that perhaps this could 
be handled by guidance to the IBCs. Dr. Novick responded that this 
seems like a reasonable proposal, and that the question of registering 
exempt experiments will be taken up separately. Dr. Walters reminded the 
RAC that NIH currently does not require registration of exempt experiments 
with IBCs. Dr. Novick said that the issues are tied together. Mr. Thornton 
suggested that the proposed exemption could be prefaced by the words "Subject 
to the prior notification and approval of the local IBC, " 
Dr. Baltimore preposed adding a sentence to the effect that principal 
investigators and IBCs should take cognizance of biologically active polypeptides 
produced by E. coli K-12 strains. He said that this would give the sense 
of the RAC's concern, but not specify procedures. 
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