on September 5, 1986, and a report of that meeting was made to 
the RAC at the September 29 , 19 86 , meeting. At that time, the RAC 
had voted to refer the matter back to the working group for 
further discussion. He noted that the RAC, during the same 
meeting, had approved a motion to modify Section III-A-2 dealing 
with environmental release. 
Dr. McGarrity stated that the working group had met on December 
5, 1986, and the minutes of that meeting were contained at tab 
1285. He reported the first proposal to the RAC from the working 
group (endorsed by a vote of 10 in favor, 1 opposed, and 1 
abstention) was to revise Section III-A-2 of the NIH Guidelines 
to read in its entirety as follows (tab 1286/11): 
"Deliberate release into the environment of 
any organism containing recombinant DNA, 
except those listed below. The term 
'deliberate release' is defined as a planned 
introduction of recombinant DNA-containing 
microorganisms, plants, or animals into the 
environment. 
“a. Introductions conducted under conditions 
considered to be accepted scientific 
practices in which there is adequate evidence 
of biological and/or physical control of the 
recombinant DNA-containing organism. The 
nature of such evidence is described in 
Appendices L, M, N, and 0. 
"b. Deletion derivatives not otherwise 
covered by these Guidelines. 
"c. Organisms covered in exemption III-D-2." 
Dr. McGarrity then stated the intent of the working group was 
that Appendix L, referred to in the proposed wording, would be 
the current Appendix L dealing with plants, with future changes 
to be recommended by RAC. Appendices M, N, and 0 would be 
parallel sections, yet to be written, covering respectively 
animals, microorganisms other than those used in vaccines, and 
vaccines . 
Dr. McGarrity reported that the working group unanimously 
approved a motion that: 
"Investigators in the field of vaccine development be 
apprised of the options for exemption from RAC review 
as specified in paragraph two of Section III-A, and 
that a working group be organized to develop criteria 
and procedures for inclusion in an Appendix O 
(Vaccines) of Section III-A-2." 
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