I. Definition of Deliberate Release. 
Dr. McGarrity called the meeting to order and asked the observers to 
introduce themselves. He restated the charge to the working group and 
sunmarized the actions taken at the September 5, 1986, meeting of the working 
group. He noted that the Recombinant DNA Advisory Committee (RAC) had 
recommended approval of Dr. Gottesman's proposed amendment of Section 
III-A-2 of the National Institutes of Health (NIH) Guidelines for Research 
Involving Recombinant DMA Molecules at its meeting on September 29, 1986. 
However, the NIH Director has not yet acted on this recommendation. The 
RAC referred the other recommendations back to the working group for further 
consideration. 
Dr. Gartland summarized a meeting on environmental release issues sponsored 
by the National Research Council at Millwood, VA, on October 27-28, 1986. 
He also summarized the conclusions and distributed a ccpy of the Report of 
the Committee to Review Allegations of Violations of the NIH Guidelines 
for Research Involving Recombinant ENA Molecules in the Conduct of Field 
Tests of a Pseudorabies Vaccine at Baylor College of Medicine and/or Texas 
A&M University. In response to a question. Dr. Milewski of the Environmental 
Protection Agency (EPA) stated that the purpose of the meeting of the EPA 
Biotechnology Science Advisory Committee subcommittee on environmental 
release on December 11-12, 1986, is to prepare several options for the 
definitions of "deliberate release" for use in EPA rulemaking procedures. 
The working group agreed to focus on matters pertaining to NIH and leave 
integration of agency decisions to the Biotechnology Science Coordinating 
Committee. 
Dr. Vidaver then suggested that a second sentence be added to the definition 
of "deliberate release" which she had proposed at the September 5, 1986, 
meeting. The two sentences to be added to Section III-A-2 would read as 
follows : 
"The term 'deliberate release' is defined as a planned introduction 
of recombinant DNA-containing microorganisms, plants, or animals into 
the environment. This is the experimental use of microorganisms, 
plants, or animals under conditions considered to be accepted scientific 
practice." 
The appendices to be developed would incorporate the accepted practices. 
Drs. Korwek and Gottesman questioned how unplanned introductions would be 
treated if this definition is adopted. Drs. McGarrity and Vidaver pointed 
out that these sentences would be added to Section III-A-2, and the heading 
of Section III-A, "Experiments That Require RAC Review and NIH and IBC 
Approval Before Initiation," indicates that Section III-A-2 applies to 
experimental releases. Dr. McGarrity said that these sentences would 
presumably be added to the end of Dr. Gottesman's proposed revision of 
Section III-A-2. 
Dr. Sharpies then proposed an alternative rewrite of Section III-A-2 as 
follows: 
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