18 
if genetically engineered be treated as etiologic agents? She said that 
if packages containing plant materials are labeled as etiologic agents as 
specified in Appendix H, the shipment will be stopped at borders by the 
Animal and Plant Health Inspection Service (APHIS) of USDA and denied entry. 
Dr. Gartland asked if plants or plant parts could be packaged for shipment 
as described in Appendix H, i.e., a glass vial inside of a cardboard box 
inside another cardboard box. Dr. Tolin replied that plant cells in culture 
or very snail plants might be shipped in this way. Larger plants could 
not be shipped in that fashion as they would not survive transport packaged 
in this manner. 
Dr. Barkley thought the packaging requirements were appropriate for shipping 
microorganisms and viruses. However, he thought the Guidelines should only 
require recombinant DMA containing organisms which are etiologic agents 
themselves or contain DNA from etiologic agents to be labeled as etiologic 
agents. 
Dr. Gottesman suggested that Appendix H be revised with respect to shipping 
plants containing recombinant DNA. 
Dr. McGarrity suggested that if the language of Appendix is to be recon- 
sidered or rewritten, language describing the shipping regulations for 
agents grcwn in countries where foot and mouth disease is endemic should 
be evaluated and perhaps included. Dr. Landy asked if such cases fall with- 
in RAC's purview. Dr. McGarrity said recombinant DNA containing viruses 
would be within RAC's purview. 
Mr. Mitchell suggested that Dr. Tolin and an ad hoc working group examine 
Appendix H for potential revision. 
XII. CLOSING REMARKS AND ADJOURNMENT 
Mr. Mitchell noted that RAC had held a session closed to the public earlier 
in the day to discuss proprietary information. He said a suggestion was 
made that RAC review tlose issues in proprietary proposals which are 
generic in open session and those that are proprietary in closed session. 
Review of these applications indicates this might be very difficult to do. 
He asked whether such a review procedure could be devised. Ct. Clowes said 
it might be possible to divide such proposals into portions for discussion 
in public and portions for discussion in closed session, but he did not 
knew if such a procedure would be practical. 
Dr. Wensink suggested that ORDA negotiate with the submitter to determine 
what might be discussed in open session. Dr. Harvin suggested that the 
opinion of the NIH legal advisor be sought. 
Dr. Gottesman pointed out that compliance with the Guidelines by industry 
is voluntary. She did not think procedures should become so difficult 
r 202] 
