organisms listed below (including shuttle vectors constructed 
from vectors described in Appendix Q, propagated and 
maintained in the organisms listed below are exempt from 
the Guidelines.” 
Dr. Clowes stated that Dr. Burke is working with Bacillus sphaericus of which there are a number of species that are 
pathogenic for mosquito larvae. Previously, in January 1986, the RAC reviewed a recommendation from a working 
group considering a request from Dr. Richard Novick to extend the numbers of microorganisms exempted from the NIH 
Guidelines based on the fact that they readily exchanged genetic material. This resulted in addition to the NIH 
Guidelines of Appendix C-V, entitled "Extrachromosomal Elements of Gram Positive Organisms." The list in 
Appendix C-V includes many Bacillus species. 
Dr. Clowes stated that Dr. Burke would like to have Bacillus sphaericus added to Appendix C-V and that Dr. Burke has 
provided much positive evidence to show that this organism does have plasmids which can freely transfer to other 
organisms in Appendix C-V including Bacillus subtilis and Bacillus licheniformis. Dr. Burke has cited experiments in 
which he has transferred, using protoplast transformation, broad host-range plasmids from Staphylococcus aureus to B. 
sphaericus and has shown they are quite stable. Dr. Burke has also shown by co-cultivation he can transfer and 
maintain a broad host-range plasmid from Streptomyces facaelis into B. sphaericus. 
Thus, Dr. Clowes stated. Dr. Burke has demonstrated the fact that B. sphaericus would be an appropriate addition to 
Appendix C-V, and that he was fully in favor of such a recommendation. 
Both Dr. Cohen and Dr. Davis agreed with Dr. Clowes that the presentation was thorough and well presented and 
neither could disagree in any way with Dr. Clowes' recommendation. 
Mr. Mitchell then asked for anyone in opposition to such a proposal, and seeing no opposition called for Dr. Clowes to 
make a formal modon to add Bacillus sphaericus to Appendix C-V of the NIH Guidelines. 
Dr. Clowes moved the addition of Bacillus sphaericus to become a part of Appendix C-V of the NIH Guidelines, and 
the modon was duly seconded by Dr. Cohen. 
Mr. Mitchell called for discussion on the modon and hearing none put the modon to a vote. The result of the vodng 
was an approval of the modon by a unanimous vote of 19 in favor, none opposed and no abstendons. 
VI. PROPOSED AMENDMENT OF SECTION III-A4 
Dr. Wallers presented the proposed amendment (tabs 1261/1, 1265, 1270, 1271) as requested to be on the agenda by the 
Committee for Responsible Genetics (CRG) in a letter dated March 26, 1986 (tab 1265). This statement was duly 
published in the Federal Register of June 25, 1986 (tab 1261) and proposes text be added at the end of Section III-A-4 of 
the NIH Guidelines as follows: 
"The RAC will not review and the NIH will not approve 
any human genetic therapy: 
"1. that is not aimed solely at the relief of a life-threatening 
or severely disabling condition; or 
"2. that could alter germ line cells. 
"Furthermore, the RAC will not review and the NIH will 
not approve any in vitro recombinant DNA experiments 
that alter human germ line cells or early human embryos." 
Dr. Walters then briefly outlined the rationale presented with the proposal, which was divided into four parts. 
Somatic Cell Therapy for the Treatment of Disease 
Recombinant DNA Research, Volume 1 1 
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