85 
logical testing and certification for interstate shipment of such turtles, in order 
to prevent the spread of salmonella. This regulation was made final in the Federal 
Register of November 18, 1972 (37 F.R. 21670). 
On the basis of additional information showing that the certification program 
was not effective, FDA issued two additional alternative proposals in the Federal 
Register of May 28, 1974 (39 F.R. 18463) that would either prohibit the sale and 
other distribution of small pet turtles or would improve the certification scheme 
and impose additional requirements on the sale and shipment of these turtles. 
In discussing the first of his two alternative proposals in the preamble, the Com- 
missioner stated that : 
“Under the Public Health Service Act, the Commissioner has the authority to 
extend a prohibition on distribution of all turtles and turtle eggs, whether or not 
they have passed through interstate commerce, if in his judgment such a com- 
plete ban would be necessary for effective control over the interstate spread of 
turtle-associated diseases.” (39 F.R. at 18464.) 
On the basis of the comments received, the Commissioner issued a final regula- 
tion in the Federal Register on May 23, 1975 (40 F.R. 22543), banning all such 
turtles from intrastate and interstate commerce. In paragraph 13 of the preamble, 
on page 22545, the Commissioner specifically rejected a suggestion that the turtles 
should be banned from interstate shipment but should be permitted for intrastate 
shipment. 
Subsequently, the State of Louisiana brought suit to enjoin enforcement of 
this regulation on a variety of legal grounds. In State of Louisiana v. Matthews , 
427 F. Supp. 174 (E.D. La. 1977), the Court upheld the legality of the regulation 
against all challenges. Specifically, the Court ruled that FDA could properly ban 
all small turtles rather than only those turtles shown to be infected and thus 
to be health hazards, on the ground that “Congress has granted broad, flexible 
powers to Federal health authorities who must use their judgment in attempting 
to protect the public against the spread of communicable disease.” The Court 
rejected, as unproven, a contention that less drastic means of regulation would be 
sufficient to protect the public. It ruled that Section 361 permits FDA to control 
intrastate as well is interstate activity. Finally, it rejected a contention that the 
regulation is discriminatory because there are no other comparable regulations. 
For another court decision broadly upholding the discretion of HEW to enforce 
Section 361 see United States v. Shinniclc, 219 F. Supp. 789 (E.D. N.Y. 1963). 
IY 
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 implementation of Section 361 until the late 1960s when responsibility for 
implementation of its foreign aspects were delegated to CDC and for imple- 
mentation 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 
citation, 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 transportation 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 pre- 
vent 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 establishments, under the 
general provisions of Section 361. Development of the Pasteurized Milk Ordinance 
and Code, through the Interstate Milk Shippers Conference, has had a major 
imnnot on milk sanitation. The PMO provides detailed requirements for the 
handling of milk and dairy products on the farm, in order to prevent the possi- 
[Appendix B — 344] 
