26 
effort to ocme to gripe «dth balancing potentied risk versus potential 
benefit. He pointed out that virtu^dly all of the points raised by RAC 
had been discussed and carefully evaluated by the voidcing group. The 
focTMt beised on phanIeloologic^d criteria is an extremely conservative 
approach since many f^Krtors other than the toxin itself are of great con- 
sequence in pathogenicity. Dr. Maais si^iported Dr. Levine's statement. 
The proposal is conservative; it clarifies the issues and distinguishes 
between potent and nonpotent toxins. He offered a substitute motion to 
accept the p^opos^d as it appe 2 uped in the F^edered Register with the pro- 
vision that these restrictions override adl other sections of the Guide- 
lines, e.g., exanptions, self-cloning, etc. Dr. Pedoroff seconded the 
motion. 
Dr. Got teaman offered the following amendments to the proposed ^ls it 
appeeured in the Federal Register ; 
(1) The words "PI HO." will be substituted for the words "Section III-O." 
(2) Language indicating that these specifications will override other 
sections of the Guidelines, e.g., "exemptions" and "return to host 
of origin" will be added to Section I-D-2 of the Guidelines. 
(3) Langu^lge describing treatability of enterotoxin effects will be deleted. 
Dr. Maas accepted the proposed amendments. 
Dr. Bems said he supported the proposed l^u 1 guage in a gener^d sense, but 
felt RAC must monitor toxin experiments. He said he would support the 
proposal if language requiring registration of toxin experiments with 
ORDA was incorporated. 
Dr. Ma£is accepted this suggestion as an amendment. Dr. Adelberg urged the 
conmittee to sipport Dr. Maas' amended motion, as he felt Dr. Nightingale's 
proposal would simply postpone the discussion. Dr. McKinney edso urged 
the canmittee to accept the proposal. Dr. Fedoroff complimented the 
working group for an extremely thoughtful, thorough treatment of a very 
difficult subject. Dr. Nightingale said that she supported the substitute 
motion. 
Dr. Gill suggested a clarification in the proposed lemguage in regard to 
registration with ORDA; he suggested the sentence "Experixnents involving 
toxins that are lethed. at 100 micrograms or less shall be registered with 
ORDA" be added to Section 1, G^ierad Information , of proposed Appendix G. 
Dr. Qottesman agreed, as did Dr. Maas' Dr. Williams called for the vote 
on the question. By a vote of fourteen in favor, three opposed, and one 
abstention, the call for the question carried. Mr. Thornton then Ccilled 
the vote on Dr. Maas' substitute motion as amended. This was to substitute 
the motion proposed by Dr. Maas, i.e., to accept the language in the Federal 
Register (1015/VIII) with four changes: 
(1151 
