DEPARTMENT OF TRANSPORTATION 
RESEARCH AND SPECIAL PROGRAMS ADMINISTRATION 
WASHINGTON. DC. 20590 
SEP 2 9 1978 
REFER TO 
Director 
National Institutes of Health 
Bethesda, Maryland 20014 
Dear Sir: 
The following are comments on the July 28, 1978, publication of the NIH 
proposed revised guidelines of recombinant DNA research. The comments 
deal only with the transportation impacts of the revised guidelines. 
1. The revised guidelines address transportation at Section II-C, and 
also the supplemental "Laboratory Safety Monograph". The revised guide- 
lines would be the operative document from an enforcement standpoint, 
while the Monograph is merely illustrative of the requirements to be 
established in the guidelines. As a practical matter, the Monograph now 
makes fairly clear what is intended in the revised guidelines, but we 
believe the guidelines should be so drafted as to leave no question on 
intent or enforceability. Since present DOT requirements do not apply 
to recombinant DNA materials, the guidelines must stand on their own 
until DOT is able to propose and implement transportation rules in 
support of NIH. Due to the possibility that the revised guidelines may 
attain the status of law by legislation, we think it prudent to consider 
enforcement in the drafting. 
2. It is possible to understand II-C of the revised guidelines to mean 
that adherence to packaging requirements in 42 CFR 72.25 is necessary 
only if the host or vector organism is a listed etiologic agent. The 
language of II-C should expressly subject shipments of RDNA containing 
organisms and viruses to the specified requirements of 42 CFR 72.25, 
since one could "comply" with that section under the present II-C draft 
by shipping an RDNA containing organism that is not listed in 42 CFR 
72.25(c). 
3. If a separate set of restrictions are to be used for RDNA molecules, 
not contained in an organism, that point should also be established in 
the text of II-C. In Section V.D. of the Monograph, shipment of RDNA 
molecules is to be subject only to very limited packaging restrictions 
which are essentially paraphrased from 42 CFR 72.25(b), but not mentioned 
in the text of II-C. 
4. Reference in the revised guidelines to tariff C.A.B. No. 82 is, in 
our opinion, unnecessary. The tariff merely describes the conditions 
[A-408] 
