COVINGTON & BURLING 
Gilbert S. Omenn, Ph.D., M.D. 
January 6, 1978 
Page Six 
Interstate Milk Shippers Conference, has had a major impact 
on milk sanitation. The PMO provides detailed requirements 
for the handling of milk and dairy products on the farm, in 
order to prevent the possibility of communicable disease. 
The growing conditions for shellfish have similarly been 
the subject of control since 1924 under the National Shell- 
fish Sanitation Program, and’ FDA has proposed to establish 
regulations codifying this program in the Federal Register 
of June 19, 1975 (40 F.R. 25916), which are now being held 
in abeyance pending further study required by Congress in 
Section 16(b) of PL. 94-370 (90 Stat. 1013, 1033). FDA 
proposed to codify its 40-year history of cooperation on 
food sanitation programs for food service establishments in 
the Federal Register of October 1, 1974 (39 F.R. 35438) , and 
has since concluded instead to issue a model ordinance as 
announced in the Federal Register of March 22, 1977 (42 
F.R. 15428). Under the same authority, FDA has announced 
a proposed Model Retail Food Store Sanitation Ordinance in 
the Federal Register of October 25, 1977 (42 F.R. 56367) and 
a Model Vending of Food and Beverages Ordinance in the 
Federal Register of October 7, 1977 (42 F.R. 54626) . 
Finally, in a variety of regulations in the past few 
years designed to implement a national blood policy, FDA has 
utilized Section 361 to control blood banking and blood 
labeling practices in intrastate as well as interstate com- 
merce. The preambles to these regulations specifically 
mention the need for close control of all blood practices, 
in minute detail, in order to prevent communicable disease. 
Copies of the proposed regulations to establish current good 
manufacturing practice for blood and blood components pub- 
lished in the Federal Register of May 28, 1974 (39 F.R. 18614) 
and to require a label statement to distinguish volunteer 
from paid blood donors published in the Federal Register of 
November 14, 1975 (40 F.R. 53040), both of which discuss this 
subject, and both of which provide extraordinary detailed 
requirements, are enclosed. 
V 
Questions have been raised about the degree and nature 
of the potential harm that must be shown in order to invoke 
the authority of Section 361. It appears that the language 
of the statute itself, its legislative history, and the court 
[Appendix A — 262] 
