91 
seq. and 21 U.S.C. 451, ct seq.). These laws are mainly concerned with providing 
wholesome and safe meat and poultry products to the public. Any meat or poultry 
products which ate “adulterated”, tvithin the meaning of that term, would come 
under the prohibitions of said Acts. If sucli “adulteration'’ were related to the 
administration of products resulting from DNA research or to exposure to orga- 
nisms containing recombined DNA. then the provisions of these Acts could have 
significance with respect to the area of DNA research. 
Sincerely, 
Bob Bergland, Secretary. 
The Secretary of Transportation. 
Washington, D.C., December 21, 1977. 
Hon. Adlai E. Stevenson, 
Chairman, Subcommittee on Science, Technology, and Space, U.S. Senate, Wash- 
ington D.C. 
Dear Adlai : Thank you for your letter of November 30, 1977, asking 
whether the Hazardous Materials Transportation Act (1IMTA) provides author- 
ity to deal with the transportation hazards of materials associated with recom- 
binant DNA research or its commercial application, and whether the Depart- 
ment has any plans to examine those hazards. 
The short answer to both questions is “yes.” The Department has been active 
in the work of the Interagency Committee on Recombinant DNA Research, 
chaired by the Director of the National Institutes of Helath (NIH), which ex- 
amined Federal authority that might be used to control the hazards of recom- 
binant DNA research, including transportation incident to research. In the 
course of examining our own authority under the HMTA, we concluded that the 
Act was adequate to insure transportation safety when recombinaut DNA ma- 
terials are moved in commerce. 
We presently are considering the possibility of publishing a notice of proposed 
rulemaking which would include a proposal to designate recombinant DNA 
materials as hazardous materials subject to certain precautions when shipped. 
In this regard, we expect to follow the course set by existing NIH Guidelines by 
limiting our concern to “novel recombinant DNA.” i.e. DNA segments inserted 
into species not known to exchange chromosomal DNA by natural processes with 
the species of origin. Suitable packaging could be required for novel recombinant 
DNA, such as that now required for shipment of etiological agents. The exact 
nature of any needed transportation safety requirements will depend on the 
hazards associated with the particular material. Varying degrees of hazards are 
recognized by the NIH Guidelines based on the nature of the genetic material 
involved. 
One of the peculiarities of assessing the hazards of novel recombinant DNA 
is the extent to which those hazards are unknown. However, the Secretary, under 
the HMTA, is directed to designate as a hazardous material any material which 
he finds “may pose an unreasonable risk to health and safety or property” when 
transported in commerce in a particular quantity and form. Thus, a finding that 
a particular quantity and form of a material may pose an unreasonable risk is 
sufficient to bring that material under the HMTA. 
It is not possible to give you a precise estimate of when a final decision will be 
made to publish either a notice of proposed rulemaking on recombinant DNA or 
a final rule. This is a complex, technical field that is in a state of flux. Elements 
of the scientific community have recently re-evaluated the hazards of recom- 
binant DNA research and suggest that the hazards may be less than initially 
believed. At the present time, NIH is considering revision of its guidelines and 
has solicited public comment on its proposals with a notice in the Federal 
Register. However, as a general matter, we expect that some form of transpor- 
tation control on novel recombinant DNA materials, whether generated by re- 
search or commercial activities, will be established by the Department. We also 
believe it advisable that such transportation controls as are necessary be estab- 
lished under the HMTA. to avoid difficulties and confusion that may arise 
from conflicting transportation requirements that State or local governments 
may impose. Please let me know if you have any further questions or desire an 
update on our activities in this matter. 
Sincerely, 
Brock Adams. 
23 - 890 — 78 8 
[Appendix B — 350] 
