limiting the kinds of recombinant DNA research that could be undertaken.
4. A public meeting was held by NIH on February 9th and 10th, 1976 which was announced to the public in the Federal Register. Thereafter NIH published the "decision of the Director, NIH" and NIH guidelines on recombinant DNA research on July 7, 1976. At that time NIH announced that it was preparing a draft environmental impact statement. 41 Fed. Reg. 27902 (1976). On September 9, 1976 the draft EIS was published in its entirety in the Federal Register. 41 Fed. Reg. 38426 (1976). The final EIS was prepared and notice of its availability published in the Federal Register on November 28, 1977. 42 Fed. Reg. 6588 (1977).
5. The NIH guidelines govern all facets of NIH-funded research using recombinant DNA techniques. The guidelines provide detailed requirements for both physical and biological containment designed to insure that recombinant DNA molecules will pose no threat to man or the environment. The experiment is to be conducted in accordance with these guidelines.
6. The laboratory at Fort Detrick is a P4 laboratory with extensive safeguards built into its design. The experiment is to be conducted under P4 physical containment requirements -- the highest level of physical containment. P4 facilities are governed by rules limiting access, providing for change of clothes before entering and leaving, and numerous other safety features. All recombinant DNA materials are handled in gastype safety cabinets and removed only after sterilization.
7. The experiment is to be conducted using EK2 host-vector systems. In the planned experiment, a derivative of E coli K-12 which has been specifically designed to self-destruct if removed from the controlled laboratory environment will be used. E coli K-12 itself is safe and has been used for years without known harm to the laboratory workers or to the environment.
8. E coli K-12 is unable to colonize in the human intestinal tract and causes no known human or animal disease. The EK2 system uses a K-12 derivative that must have special chemicals found only in an artificial laboratory setting in order to survive and is safer than ordinary K-12. If these chemicals are not present, the EK2 is designed to self-destruct.
9. Recombinant DNA research has already become a valuable aid in progress against illness. Benefits include applied medical advances and an accelerated understanding of the genetic and biochemical basis of the disease process.
10. The experiment is designed to provide important knowledge concerning recombinant DNA technology.
11. The experiment poses no substantial risk to human health or to the environment because (1) there is little likelihood the materials will escape from the maximum containment of the P4 facility; (2) if such an escape did occur, the recombinant DNA molecules would not survive but would self destruct outside the laboratory environment; and (3) the particular virus being used has never been implicated in human disease.
12. Plaintiff has offered no evidence to show that he will suffer irreparable injury or that there is any significant possibility that the experiment will have an adverse impact on the environment.
CONCLUSIONS OF LAW
1. Plaintiff has not shown that he would be irreparably injured unless a preliminary injunction is granted.
2. Plaintiff has not sustained the burdens imposed upon him by Virginia Petroleum Jobbers Association v. FPC 104 U.S. App. D.C. 106, 259 F.2d 921 (1958) in that he has failed to demonstrate that he would be irreparably injured in the absence of the issuance of an injunction, that he is likely to prevail upon the merits of the controversy, and that the public interest lies in granting the requested relief.
John Lewis Smith, Jr.
United States District Judge
Dated: February 23, 1978
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