74 
of recombinant DXA research and related activities. Responses to 
questions directed to the Food and Drue: Administration are also in- 
cluded in this letter. 
1. Section 3G1 of the Public Health Service Act 
Section 361 authorizes the Secretary of HEW to take action to pre- 
vent the introduction, transmission, and spread of communicable dis- 
eases from foreign countries and from State to State. The Interagency 
Committee on Recombinant DXA Research examined existing laws, 
including section 361, to determine if they provided adequate authority 
to regulate all recombinant DXA activities. The Committee concluded 
that new and specific legislation was needed. 
The Committee’s report (a copy of which is enclosed) released 
March 15, 1977, contains the following conclusion concerning section 
361: 
“Section 361 could perhaps be interpreted more broadly to serve as 
legal support for more comprehensive regulation. However, in order to 
do so there would presumably have to be a reasonable basis for con- 
cluding that the products of all recombinant DXA research cause or 
may cause human disease. Such a conclusion would undoubtedly be 
tenuous at best, and it is unlikely that resulting requirements could be 
effectively imposed and enforced.’’ 
On Xovember 11, 1976, the Environmental Defense Fund and the 
Natural Resources Defense Council filed a petition with the Secretary 
of HEW asking him to impose regulations on all recombinant DXA 
activities, citing section 361 as authority (see Appendix IV of the 
Interagency Report). As explained in tlieir petition (see pp. 57-59), 
they argued that the definition of communicable disease under section 
361 can be read to include all recombinant DXA activities. 
The Department has used section 361 to regulate a number of pro- 
ducts which affect human health, including shellfish, pet turtles, pri- 
mates. milk, drinking water, and human blood. Our Office of the Gen- 
eral Counsel, however, believes it is preferable for a regulatory effort 
of the magnitude required to oversee all recombinant DXA activities, 
whether or not known to affect human health, to be based on the explicit 
support of the Congress as well as that of the Administration, partic- 
ularly in light of the active interest the Congress has shown in this area. 
The consensus needed for this type of program is not best established 
by applying a general provision of law to this specific situation. 
2. Other HEW Authorities 
The Food and Drug Administration (FDA) is responsible for as- 
suring that human drugs, biologies, medical devices, foods, cosmetics, 
and animal drugs, are safe, effective, and are produced in conformity 
with good manufacturing practices. For all new drugs, new animal 
drugs, biologies, food additives and color additives, and medical de- 
vices. the sponsor or manufacturer has the burden of demonstrating 
the safety and efficacy of product proposed for marketing. The Fed- 
eral Food, Drug, and Cosmetic Act requires manufacturers of such 
prodnets to submit safety and efficacy data supporting their petitions 
to FDA for review and approval before the product is introduced into 
interstate commerce. 
The FDA has responsibility to safeguard the public from all poten- 
tial hazards that may result from the development of products that are 
[Appendix B — 333] 
