DEPARTMENT OF HEALTH Sl HUMAN SERVICES 
Public Health Service 
National Institutes of Health 
Memorandum 
Oate 
From 
Subject 
To 
Director 
Division of Safety 
Shipment of rCNA Molecules 
Director, ORTA, NIAID 
As ycu are aware the U.S. Postal Service Is proposing to exclude 
etioJnqic scents from the maiA. This action will impact on the 
shipment or rixtA molecules in the U.S. Mail. 
The exclusion of rCNA molecules will occur because of the definition 
*ind criteria contained in Appendix H of the Guidelines. This Appendix 
states that all rCNA molecules contained in an organism or virus shall 
be shipped as an etiologic agent. This restriction does not take into 
account the character of the rCNA molecule or the host organism. This 
means, for example that a ncn-toxic molecule contained in an organism 
that is not a human pathogen would be excluded from the U.S. Mail. 
On the other hand, the U.S. Postal Service (FR 53 (122) , June 24, 
1988, p. 23775 defines an etiologic agent as viable microorganisms or 
their toxins which causa or may cause human disease. 
The broad definition of etiologic agent contained in the CNA 
Guidelines offers sane potential problems in interpretation by the U.S. 
Postal Service. Therefore, it is recommended that the definition in 
the ENA Guidelines be reconsidered. 
It is suggested that the requirements for shipment of rCNA molecules be 
based primarily on the character of the molecule and secondarily on the 
character of the host. This approach would provide for the continued 
shipment (by mail) of benign rCNA molecules in ncn-etiologic organisms 
**= biological products. The packaging requirements for such shipments 
would be as already prescribed in the Guidelines except that an 
etiologic agent label would not be required. 
I do not knew whether there would be an advantage in coordinating this 
issue with the EPA, USDA and FDA. These agencies certainly have 
interests in this area and will likely be impacted by the proposed 
changes in postal regulations. 
Recombinant DNA Research, Volume 13 
(383J 
