90 
Department of Agriculture, 
Office of the Secretary, 
Washington, D.C. , December 23, 1977. 
Hon. Adlai E. Stevenson, 
Chairman, Subcommittee on Science, Technology, ana Space, 
U.S. Senate, Washington, D.C. 
Dear Mr. Chairman : This is in reply to your inquiry dated November 30, 
1977, regarding authorities to regulate products of DNA research and microbes 
or other organisms containing recombined DNA. Specifically, you requested to 
be advised whether the Animal and Plant Health Inspection Service (APHIS) 
of this Department has the authority to control microbes or other organisms 
containing recombined DNA in animals and plants, and whether authority exists 
to directly control organisms containing recombined DNA. 
Since this is a relatively new area of scientific endeavor, and since the end 
results of DNA research are still mostly conjectural, we cannot specifically 
point to any statute administered by APHIS which would be definitely ap- 
plicable to such research. However, there are several statutes which are ad- 
ministered bv APHIS which may ultimately be affected by either the end 
products resulting from DNA research or by organisms containing recombined 
DNA. , . , _ . 
The major programs that are administered by APHIS under winch certain 
products of DNA research or organisms containing recombined DNA could be 
regulated are as follows : 
A. The Animal Quarantine laws, especially 21 U.S.C. 111, Ilk, llk(h), 123 and 
134(a) 
The main purpose of these laws is to prevent the introduction into the United 
States, or the dissemination from one State or Territory or the District of Co- 
lumbia to another of the contagion of any contagious, infectious, or communi- 
cable disease of animals and/or live poultry. Under these laws, the Secretary 
of Agriculture has the authority to promulgate such regulations and to take 
such measures as he may deem proper to prevent such introduction or dissemi- 
nation. Any product of DNA research or any organisms containing recombined 
DNA which could be classified as such a “contagion” would be subject to the 
Animal Quarantine laws. 
Section 122.2 of Title 9, Code of Federal Regulations, applies specifically to 
organisms and vectors. It states that no organisms or vectors shall be imported 
Into the United States or transported from one State or Territory or the District 
of Columbia, to another State or Territory or District* of Columbia without a 
permit. Organisms are defined in section 122.1(e) of Title 9, Code of Federal 
Regulations as “All cultures or collections of organisms or their derivatives, 
which may introduce or disseminate any contagious or infectious disease of 
animals (including poultry).” 
B. The provisions of the Virus-Serum-Toxin Act (21 U.S.C. 151, et seq.) 
The purposes of this Act. as stated in the Legislative History (See, e.g., Senate 
Committee Report No. 1288 on H.R. 28283, 62nd Congress) is to prevent “the 
introduction into the United States of dangerous and worthless viruses, serums, 
and analogous products for use in the treatment of domestic animals . . . and 
also for the purposes of controlling the use, by preventing the interstate ship- 
ment, of similar dangerous, and worthless products that may be manufactured 
within the United States”, 
Therefore, products of recombinant DNA research which could be considered 
viruses, serums, toxins or analogous products (i.e., veterinary biologies), as 
well as any recombined DNA containing organisms used to produce them, which 
are subject to the provisions of the Virus-Serum-Toxin Act, would also be subject 
to APHIS regulation. 
C. The Federal Plant Pest Act. particularly 7 U.S.C. loObb and 150dd 
This law is mainly concerned with the prevention of the dissemination of plant 
pests in the United States. The Secretary of Agriculture has the authority to pre- 
vent the introduction of such pests which are moved from a foreign country into 
the United States, or interstate. Therefore, any products of DNA research or or- 
ganisms containing recombined DNA which fall under the category of plant pests 
would be subject to regulations by APHIS. 
There are, of course, other authorities which might have an impact in this 
area, such as the Federal Meat and Poultry Inspection Acts (21 U.S.C. 601, et 
[Appendix B — 349] 
