5 
nr. Hirano aoreed; she felt the language did not clearly indicate vhether the 
monitoring should occur in the greenhouse and grcwth chamber or in the field. 
5The suggested monitoring requirements should be addressed in Section XV— A of 
the document. .She thought Section IV-B is related to risk assessment and 
should be part of Section V of the document. 
Or. Vidaver suggested the title of Section V be modified; she pointed cut that 
the draft document as it stands contains two sections entitled "Summary." 
Dr. Lacy suggested the document should use the phrase microorganism modified 
using reccmbinant DNA techniques" rather than refer to a reccmbinant organism. 
Dr. Golwell sugoested the phrase "testing or application in the environment" 
might be preferable to the phrase "release into the environment." He suggested 
the phrase "testim or application" be siiostituted throughout the document 
for the word "release." 
Dr. Pirone noted that the Working Group on Human Gene Therapy addressed two 
issues that the Working Group on Release into the Environment might wish to 
consider: (1) the experience and competence of the investigator; and (2) 
whether alternative methods of obtaining the same result exist. He said the 
second Question would ask vh ether the organism could be constructed by some 
other methodology. Dr. McGarrity thought the investigator would address these 
types of issues in the justification. 
Dr. Arntzen asked whether the working group document should state that these 
points to consider would not apply' if another agency is required to review the 
protocol. Dr. Gartland said the NIH Guidelines currently require investigators 
to come to the NIH for review regardless of whether they are required to submit 
their proposals to other agencies for review. Should the working group feel a 
different procedure would be desirable, the group would have to request that 
the NttH Guidelines be modified. Dr. Gottesman pointed out that the RAC and 
its working groups are currently the premier bodies of expertise; the advice of 
these bodies is needed by all the Federal agencies. 
Dr. Amtzen noted that other government agencies have developed testing require- 
ments for reviewing introductions of novel organisms into the ecosystem; he 
offered the example of EPA testing protocols for biopesticides. Dr. Gottesman 
pointed out that such testing protocols do not address all of the issues facing 
the working group. Dr. Anne Hollander of the EPA agreed with Dr. Gottesman; she 
said the EPA is currently attempting to develcp appropriate testing requirements 
for field testing of modified organisms. 
Dr . Vidaver asked why the concept of risk assessment had been included in the 
preamble. She suggested this concept be discussed in a separate section at 
the end of the document; she felt it was not good public relations to mention 
the concept of risk in the preamble to the document. Dr. liacy agreed; he felt 
the information submitted in response to questions posed in the body of the 
document would be synthesized to assess risk. 
[ 182 ] 
