Recombinant DMA Advisory Committee - 
Dr. Sue Tolin of the USDA noted that on February 1, 1991, the proposed IJSDA 
Guidelines for Research Involving Planned Introduction into the Environment of Organisms 
with Deliberately Modified Genetic Traits was published for a 60-day comment period. 
She said it describes the principles for assessing research safety with specific organisms 
and designing confinement measures to promote safety. She noted that the deadline for 
comment on these guidelines is April 2, 1991, after wWch the USDA will consider the 
comments received. She emphasized that this document in no way includes a triggering 
mechanism for regulation and implementation. Another document being worked on 
separately and will be forthcoming. 
Dr. Miller asked if these guidelines were aimed only at USDA-funded research. Dr. 
Tolin responded that since there is no implementation phase they are not pointed toward 
regulation. She said they are principles for assessing safety which are intended to be 
similar to Points to Consider, to aid principal investigators in designing research so that it 
can be conducted safely outside contained facilities. She noted that the document 
encourages institutions to utilize IBCs to aid in safety evaluation and confinement design. 
She said it was written primarily for USDA-funded research but could be viewed as not 
being exclusively pointed at it. 
Dr. Miller pointed out that one of the problems that confounds regulatory agencies is the 
ability to create exemptions. This could bring the NIH back into the picture because it 
would not be under the jurisdiction of another agency if it falls into a regulatory 
exemption. Other mechanisms do exist for overseeing non-recombinant organisms that 
range from little risk to high risk and deal with field trials of plants and domesticated 
foodstuffs. Such mechanisms seem to function reasonably well. 
Dr. Shibley of USDA said that for some time the Animal and Plant Health Inspection 
Service (APHIS) has been doing environmental assessment, looking at both conventional 
products and products containing recombinant DNA. 
Dr. Hirano asked how often ORDA received requests from researchers or IBCs relevant 
to environmental release. Dr. Wivel said that most inquiries occur with respect to 
Appendices P and Q, since people are aware that these documents are in the process of 
being promulgated. Most investigators are using the 1987 Federal Register, which 
contains the draft language of Appendices P and Q, as an unofficial guide to those 
experiments. 
Dr. R. Murray said that this was one area where there seemed to be unanimity among 
the members of the committee and the subcommittee. He moved that the RAC consider 
deleting this trigger mechanism for environmental release. 
Dr. Mclvor seconded the motion. 
Recombinant DNA Research, Volume 14 
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