contained, in an organism or virus." He emphasized that many 
shipments fall outside of this definition and, therefore, would not 
be treated as etiologic agents. Nonetheless, if the recombinant 
DNA molecule is contained in a plasmid not within an organism, it 
would be treated as a recombinant organism. 
Dr. Stevenson interjected that before the Subcommittee addressed 
such technical subjects, two generic issues must be explored. 
First, everyone wants to protect the public health; in particular, 
the Subcommittee needed to address the safety of postal workers who 
may be exposed to the risk of infection due to the shipment of 
certain products. Second, there is concern that the shipped 
materials could find their way to an unfriendly country or 
terrorist group who might use them for biological weapons purposes. 
The Departments of State and Defense wish to define and control 
such materials; these concerns illustrate that the generic 
definitions of recombinant DNA activities extend beyond those of 
the molecular biology community. 
Mr. Brewer agreed with Dr. Stevenson. He suggested that the 
Subcommittee evaluate whether Appendix H reflects "good science" in 
the abstract. Such an approach would address issues of health and 
safety both inside and outside the laboratory as well as the basic 
questions of public policy objectives. Dr. Stevenson added that 
the definitional issues extended to the inclusion of transgenic 
mice . 
Dr. McKinney asked whether the NIH Guidelines should include all 
appropriate regulatory statutes that apply to shipment. The 
Departments of Agriculture, Commerce, and Transportation have 
various regulations for the shipment of recombinant DNA products. 
He believed that to incorporate all of these regulations into the 
NIH Guidelines would be unreasonable and lead to an encyclopedic 
document, and thus overstep the mandate of the RAC. He suggested 
that the Subcommittee's recommendations be advisory. 
Dr. Stevenson shared these concerns, but argued that this 
Subcommittee was not the proper place to address them. He noted 
that recombinant DNA regulations and guidelines need a focal point; 
in addition to the NIH Guidelines, a myriad of government agencies 
are creating conflicting regulations and often fail to consult one 
another. These were largely bureaucratic problems. Furthermore, 
he argued, the Subcommittee should not worry about its formal 
mandate. If no law specifically prohibits actions, then they can 
be initiated. He suggested the Subcommittee come up with a 
definition of recombinant DNA products for shipping purposes, 
circulate it to the appropriate agencies for comment, and if there 
are no objections, publish it as an action in the NIH Guidelines. 
[Rapporteur's note: Subcommittee recommendations are referred to 
the RAC and published in the Federal Register for public comment. 
In a public meeting, the RAC votes to transmit recommendations that 
are advisory to the Director, NIH. If these recommendations are 
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