Mr. Brewer, Chair, called the meeting of the Definitions 
Subcommittee of the Recombinant DNA Advisory Committee (RAC) to 
order at 9:04 a.m. on December 5, 1988, and asked all those present 
to introduce themselves. 
Mr. Brewer opened the discussion by stating that the Subcommittee 
had convened in order to develop a recommendation to the RAC 
addressing the issue of the definition of recombinant DNA products 
for shipping purposes. At the October 3 RAC meeting, members 
observed that the current labeling instructions for shipping 
recombinant DNA as an etiologic agent was a serious issue that 
required attention. The RAC meeting preceded, by two days, a 
congressional hearing that discussed the problem, at which Dr. 
McVicar testified (his testimony is in Attachment II). 
Mr. Brewer noted that in order to fulfill the legal requirements of 
proper notification and allowance of time for public comment, the 
recommendations of the Subcommittee must be published in the 
Federal Register (FR) by December 30, 1988. This publication date 
would require submission to the Federal Register by December 15, 
1988, and the h '.idays add pressure to the already tight schedule. 
He concluded th : this Subcommittee meeting must vote on its 
recommendations within the next three hours. 
Mr. Brewer suggested that the Subcommittee approach the problem as 
if the Post Office had made no proposals to change the legal 
standards affecting the shipment of recombinant DNA products. He 
suggested to members that the RAC should analyze the issue 
independently of Post Office recommendations and continually review 
whether the guidelines met the following criteria: (1) consistency 
with the current "best science"; (2) protection of public health 
with an adequate margin of safety in the simplest possible way and 
at the lowest possible cost. 
Mr. Brewer turned to Appendix H of the National Institutes of 
Health (NIH) Guidelines for Research Involving Recombinant DNA 
Molecules (hereafter referred to as the "NIH Guidelines"), 51 FR 
16978 dated May 7, 1986, and the relevant attachments through 
October 1988. Appendix H describes the NIH Guidelines for the 
shipment of recombinant DNA molecules, which are to be labeled as 
"etiologic agents." Mr. Brewer asked if this policy made sense 
from a scientific perspective and what might be altered. He noted 
that the Subcommittee must take into account the regulations and 
guidelines of other Federal agencies and offices, such as the 
Department of Transportation, the Department of Health and Human 
Services, and the United States Postal Service. 
Dr. Atlas offered clarifications to the definition in Appendix H of 
recombinant DNA products for shipping purposes, which he felt were 
left unexplained at the October 3 RAC meeting. The appendix does 
not define all recombinant DNA molecules as "etiologic agents," but 
rather limits the NIH Guidelines to "recombinant DNA molecules 
Recombinant DNA Research, Volume 13 
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