27 
(1) "Section III-O" to be changed to "Pl-EKl" in Sections 2-b and 2-c 
of Appendix G. 
(2) Bie introductory text of Section 2-c of ^^pendix G dealing vdth 
treatability of enterotoxin effects to be eliminated. 
(3) Language to be added at the end of Section I-D-2 of the Guidelines 
indicating that ^pendix G specifications override other specifica- 
tions of the Guidelines (e.g., exenpticms or return to host of origin 
experiments) . 
(4) Language to be added to Section 1 of ^pendix G that experiments 
involving toxins that are lethal at 100 micrograms or less shall be 
registered with C»DA. 
By a vote of sixteen in favor, three o^^sed, and no abstentions the RAC 
adopted the substitute notion in place of Dr, Nightingale's previous motion 
to defer ccxisideration. 
Dr, Novick asked if he might offer an amendment at this point. Mr, Thornton 
said that technically he could rule no amendment was in order at this 
point in the voting process; but in an effort to permit all points of view 
to be heard, he would recognize Dr. Novick. Dr, Novick said he wished to 
add the word "prior" to the added sentence specifying registration with 
ORDA. Dr. Maas accepted E>r. Novick' s amendmait. Mr. Uxomton then called 
the vote on the motion, i.e., to accept the language in the Fe^ral l eister 
(tab 1015/VlII) with the four changes listed above including the word "prior" 
in the fourth change. The RAC adopted the modified language by a vote of 
eighteen in favor, none opposed, and one abstention. Mr. Ibomton expressed 
his appreciation to all involved in pr^>aring the proposal. 
Dr. Gill then suimiarized the risk assessment experiments preposed by the 
toxin working group (Attachment II). Mr, Hx>mton said he intended to 
refer the proposal to the Risk Assessment Subconmittee for further consid- 
eration. 
XIX. RBQUEgr TO CLONE THE VIBRIO CHCTiERAE ENTERCQOXIN GENE 
Dr. Holmes initiated discussic^ on the proposal (tabs 1002, 1010, 1015/X) 
submitted by Dr. John Mekalanos of Harvard Medical Sdxx^l. Dr, Mekalanos 
requested an exempt icwi from Section I-D-2 of the Guidelines, vAiich pro- 
hibits the formation of recombinant ENAs ccxitaining genes for the biosyn- 
thesis of toxins potent for vertebrates. Dr, Me]calanos wishes to clone 
the Vibrio cholerae sequence coding for the biosynthesis of cholera toxin. 
Dr. Mekalanos requested oonsideraticxi of the eppropriate level to perform 
three experiments in E. ooli K-12: to clone sequences coding for the 
(1) LT A subunit, (2)“Ehe LT B subunit, and (3) the LT A and LT B subunits. 
Dr. Holmes said that Dr. Mekalanos suggested experiments 1 and 2 might be 
performed under P2 + EKl containment; no active LT toxin will be syn^esized. 
Dr. Holmes said the toxin classification RAC had just adopted would indicate 
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