Recombinant DNA Advisory Committee - 5/30-31/91 
Dr. Krogstad moved for approval of the proposals, pending the changes as described in the 
previous discussions. Dr. Gellert seconded the motion. There being no further discussion, 
I the Chair put the motion to a vote. The motion passed unanimously by a vote of 19 in favor, 
I none opposed and no abstentions. 
! 
I Dr. McGarrity then called on Dr. Hirano to present the next item on the agenda. 
XII. PROPOSED AMENDMENT TO SECTION I-C-2 AND DELETION OF SECTION III-A-2 
j OF THE NIH GUIDELINES REGARDING DELIBERATE RELEASE: 
! Dr. Hirano said the two arguments that have been put forward frequently in favor of the 
proposal that the RAC and the NIH Guidelines eliminate wording related to deliberate release 
I are: 
! 1. That the RAC has not reviewed an experiment of this type for several years; 
and, 
j 2. That experiments of this type are currently being reviewed within the framework 
of existing regulations by other Federal agencies, notably the EPA and 
USDA/APHIS. 
She said that careful consideration needed to be given to this issue in order to avoid a gap 
in oversight of experiments involving recombinant organisms if these sections relevant to 
' deliberate release are removed from the NIH Guidelines. She noted that the "Coordinated 
Framework for Regulation of Biotechnology" was still not in place and that EPA and 
USDA/APHIS were really concerned with commercial applications of the technology and that 
since some experiments are looking at basic ecological questions which may not involve a 
plant pathogen, there would still be a gap in oversight for these types of experiments if the 
I NIH Guidelines were amended to remove these sections dealing with deliberate release. Also 
j she noted that experiments performed abroad are also covered by the NIH Guidelines under 
! two circumstances: 
I, 
» 
1. If they are supported by NIH funds; and, 
I 2. If they involve deliberate release into the environment or testing in humans. 
I Furthermore, she noted that paragraph III-A-2 requires RAC review, NIH approval and IBC 
approval before initiation of an experiment involving deliberate release into the environment 
j of any organism containing recombinant DNA, except for certain classes described in 
I Appendix L. She said removal of III-A-2 could be interpreted as meaning that these 
ii experiments no longer require IBC approval, and thus a void in the oversight process would 
;i be created. She said that despite the progress that has been made in oversight by other 
Federal agencies, that until there is assurance that some agency will be responsible for review 
and oversight of these experiments that the wording should not be withdrawn from the NIH 
I! Recombinant DNA Research, Volume 14 [653] 
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