COVINGTON & BURLING 
Gilbert S. Omenn, Ph.D., M.D. 
January 6, 1978 
Page Five 
no other comparable regulations. (For another court decision 
broadly upholding the discretion of HEW to enforce Section 
361 see United States v. Shinnick , 219 F. Supp. 789 (E.D. 
N.Y. 1963) . ) 
IV 
Section 361 has been applied by the Public Health 
Service and FDA in the past in a wide variety of ways. In 
general, the Public Health Service was responsible for im- 
plementation of Section 361 until the late 1960s when 
responsibility for implementation of its foreign aspects 
were delegated to CDC and for implementation of its domestic 
aspects relating to the law enforcement functions of FDA 
were delegated to FDA. (Copies of the current regulations 
issued under Section 361 by the Public Health Service in 
42 C.F.R. Parts 71 and 72, and by FDA in 21 C.F.R. Parts 
1240 and 1250, are enclosed. Do not be misled by the cita- 
tion, as legal authority for these regulations, of Section 
215 of the Public Health Service Act; that provision merely 
authorizes HEW to issue regulations to implement the Public 
Health Service Act.) 
As you will see, these regulations cover a wide 
variety of subjects. They deal in detail with the sanitation 
of interstate conveyances. The Drinking Water Standards in 
42 C.F.R. 72.201-207 relate not just to bacteriological 
quality, but also to physical and chemical characteristics 
which surely would not fall within any narrow definition of 
the concept of a "communicable disease." The Drinking Water 
Standards have been enforced as the national standard since 
1962. 
Etiologic agents are defined, and their transporta- 
tion regulated, under 42 C.F.R. 72.25. Psittacine birds, 
lather brushes, and plain garbage are regulated under 21 
C.F.R. 1240.65, 1240.70, and 1240.75, as a prophylactic 
measure to prevent disease. 
For many years, the Public Health Service, and more 
recently FDA, has engaged in joint programs with State and 
local government agencies and with the regulated industry 
to promote sanitation in the production of milk products and 
shellfish, and in the provision of food in eating establish- 
ments, under the general provisions of Section 361. Develop- 
ment of the Pasteurized Milk Ordinance and Code, through the 
[Appendix A — 261] 
