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environmental aspects of the matter. Environmental Defense Fund, Inc. v. 
Matthews, 410 F. 8upp. 336 (D.D.C. 1976). 
It is important, once again, to understand that Section 361 was intended by 
Congress broadly to authorize prophylactic public health measures to prevent 
disease before it occurs. All that is needed to support regulations under this 
provision is either apprehension or uncertainty about the possibility of potential 
harm, the lack of adequate information showing that the harm cannot occur, and 
the possibility that the harm would be serious (e.g., irreversible) if it did occur. 
The more serious the nature of the potential harm, the less is required in the 
way of apprehension of uncertainty about that harm in order to justify invoking 
regulatory controls under Section 361. 
VI 
Questions have also arisen about enforcement of any regulations issued under 
Section 361. Section 361 itself provides that any articles not in compliance with 
such regulations may be destroyed, and authorizes any other enforcement meas- 
ures that may be concluded to be necessary. In initially promulgating its turtle 
regulations, FDA included a requirement for bacteriological testing and certifica- 
tion. In its proposed shellfish regulations, other enforcement mechanisms were 
included. Each of the PHS and FDA regulations issued under Section 361 has 
its own tailor-made enforcement provisions. 
It seems clear that the statute authorizes regulations that require destruction 
of any materials resulting from activity not in compliance with regulations issued 
under Section 361. There is judicial authority for proposition that a Federal 
court, using its broad equitable powers, may enjoin violation of any validly- 
promulgated government regulation. Section 36S specifically provides for a 
fine and/or criminal incarceration. Section 361 specifically mentions authority 
for inspection as an enforcement tool. Administrative provisions requiring reports 
or imposing other enforcement mechanisms are also clearly authorized. Thus, 
it appears that there is an infinite variety of enforcement mechanisms available, 
and that any of a number could be incorporated into a regulation promulgated 
under Section 361. 
VII 
Questions have been raised about the way in which the recombinant DNA 
research guidelines could be enforced if they were proposed and promulgated 
as regulations under section 361. Clearly, it would not be necessary that the same 
government agency issue the regulations and enforce them. It would be possible, 
for example, for NIH to issue the regulations (as it presently does), and for 
CDC to enforce them. I mention CDC because it has jurisdiction over the Clinical 
Laboratories Improvement Act and thus has experience in inspection and en- 
forcement with respect to scientific laboratories. FDA might also be in a position 
to enforce the regulations, but its other responsibilities are so overwhelming that 
enforcement of recombinant DNA research regulations might better be performed 
by CDC. 
VIII 
At the recent NIH meeting, representatives of the pharmaceutical industry 
stated that industry intends to comply with the NIH guidelines and would have 
no objection to making them mandatory if certain specific problems were over- 
come. The principal problem involved their concern about submission of trade 
secret information to NIH. I stated at that meeting that this issue exists with 
respect to all regulatory agencies, and that FDA, EPA, and the others have 
resolved it without significant difficulty. 
A Federal statute, 18 U.S.C. 1905, explicitly provides that trade secret Informa- 
tion provided to the government may not be released to the public by any govern- 
ment employee under pain of criminal penalty. FDA — which regularly receives 
trade secret information from the regulated industry with respect to food addi- 
tives. new drugs, biological products, medical devices, and so forth — has issued 
extensive regulations providing that such trade secret information will be held 
in confidence by the agency and will not be released to the public. Enclosed is a 
copy of 21 C.F.R. Part 20, dealing generally with the release of information from 
FDA to the public, together with Section 314.14 relating to information in IND 
and NDA submissions (as an example of the way in which this information is 
handled). The court have now definitely held that 18 U.S.C. 1905 does in fact 
protect all trade secrets from public disclosure by government agencies. Thus, all 
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