68 
Violations of section 361 are presently punishable under section 
368(a) of the Act which provides that any person who violates section 
361, etc., ‘-shall be punished by a line of not more than 81.000 or by 
imprisonment for not more than cue year, or both. Presently, injunc- 
tive relief for violations of section 361 is not specifically authorized 
under the Public Health Service Act. 
Because of the constraints of time we are not able to provide a 
detailed comparison of the Secretary's authority under Senate Amend- 
ment 1713 and H.R. 11192 with the potential scope of his authority 
under section 361. It is obvious though, that under the pending legis- 
lation the Secretary's authority is subject to less dispute and clearly 
is more encompassing than it would be under section 361. The proce- 
dures for inspections are set out by Congress in the pending legislation. 
Should section 361 be used for regulation then HEW must develop 
its own procedures. Preemption will be accomplished under the pend- 
ing legislation whereas preemptive capacity under section 361 is un- 
likely to exist. Injunctive authority is also clearly provided for in the 
pending legislation. Furthermore, the provision in the pending legis- 
lation for a study of DMA research and its applications could be use- 
ful in providing* guidelines for future regulation of such a new and 
unprecedented area. 
We hope that this information will be helpful. If you need addi- 
tional information or analysis please feel free to call on us. 
Donna C. Parratt, 
Legislative Attorney. 
The Library of Congress, 
Congressional Research Service, 
Washington , D.C . , May 18 , 1978. 
To : Hon. Harrison H. Schmitt (Attn : Bill Gibb) . 
From : American Law Division. 
Subject: Appraisal of correspondence concerning scope of authority 
Under the Public Health Service Act. 
As you requested as a follow up to our memorandum of May 12 re- 
garding the use of section 361 of the Public Health Service Act to 
regulate recombinant DMA research, we have more carefully re- 
viewed Mr. Peter Barton Hutt’s letter of January 6 to Dr. Gilbert S. 
Omenn, We expressed the belief in our previous memorandum that 
although Mr. Hutt’s arguments appear to have some force, we could 
not reach the very broad and general conclusions he did based on our 
interpretations of existing statutory and case lav.-. You have asked 
us to elaborate on that position by addressing several particular con- 
clusions expressed by Mr. Hutt in his letter. 
First, you have asked us to analyze Mr. Hutt's position about the 
application of Section 361 to intrastate commerce. Mr. Hutt states on 
page three that this issue has been “definitively resolved by [State 
of Louisiana v. Mathetvs] upholding the legality of an FDA regula- 
tion banning all small pet turtles from both intrastate and interstate 
commerce under the sole authority of Section 361.” In the last para- 
graph on page four, he further states that the court in Lo’insiana 
“ruled that section 361 permits FDA to control intrastate as well as 
interstate activity.” 
[Appendix B — 327] 
