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MACK v. CALIFANO

February 23, 1978

FERDINAND J. MACK, JR., Plaintiff
v.
JOSEPH A. CALIFANO, JR., et al., Defendants



The opinion of the court was delivered by: SMITH, JR.

 Plaintiff seeks a preliminary injunction to prevent an experiment testing the biological properties of polyoma DNA (deoxyribonucleic acid) cloned in bacterial cells. The experiment is to be conducted in Building 550, Frederick Cancer Research Center at Fort Detrick, Maryland. Also before the Court is defendants' motion to vacate a voluntary stay.

 Defendants are Joseph A. Califano, Jr., Secretary of Health, Education, and Welfare, Donald S. Frederickson, Director of National Institutes of Health, and John E. Nutter, Chief Officer of Specialized Research and Facilities, National Institute of Allergies and Infectious Diseases, National Institutes of Health.

 A motion of the American Society for Microbiology for leave to file a brief as Amicus Curiae with respect to the public health consequences of the proposed research was granted. Counsel for the Society participated in oral argument and submitted a brief. Dr. Naum S. Bers, Rockville, Maryland, appeared individually as a concerned citizen and was granted permission to file a statement.

 Plaintiff asserts that defendants are planning to conduct experiments with polyoma, a virus known to cause cancer in mice. He states that the nature of the organisms to be created by the research is such that even a miniscule quantity, if released, in the environment would represent a threat to life and health. He further contends that the Fort Detrick experiments are to be conducted by defendants without determining the applicability of NEPA and according to the very guidelines of the Department of Health, Education, and Welfare (HEW) classified as "prohibited".

 Defendants on the other hand take the position that the EIS and NIH (National Institutes of Health) guidelines reflect the cautious manner in which the scientific community and NIH have considered the new technology involving recombinant DNA molecules. They further state that the final EIS was completed after extensive public comment and discussion of alternatives. Much of plaintiff's concern, they state, is based on an apparent misunderstanding of the nature of the materials to be used in the experiment. Plaintiff's affidavits are based on the belief that the experiment here in question will be conducted utilizing a common strain of escherichia coli (E coli) as the host-vector for the planned studies. Significantly, the NIH guidelines "prohibit certain kinds of recombinant DNA experiments which include virtually all the known hazards -- for example, those involving known infectious agents."

 The research is now restricted by these guidelines to implanting any new genes into enfeebled strains of E coli, a human gut bacteria that has been modified even further to make it safe as the new DNA's laboratory host. In the planned experiment a derivative of E coli K-12, which has been specifically designed to "self destruct", will be employed. E coli K-12 is unable to colonize within the human intestinal tract and causes no known human or animal disease. See EIS at page 73. This EK2 host-vector system will not survive passage through the intestinal tract of animals and will "die" because of its dependency on chemicals not found in nature.

 Defendants further point out that the complete experiment will be conducted in P4 physical containment laboratories which have been shown to safely contain microbes presenting a known and demonstrable hazard to man. For each certified EK2 system, "Appendix H, page 10 of the EIS", NIH reviews extensive scientific data to determine that the system meets the standards for safety. EIS at 81. See NIH guidelines, Appendix D, page 15. It is evident, therefore, that there is actually a two step distinction between the common strains of E coli which "do live in people" and the EK2 host-vector system which will be used in these experiments.

 The research involves dividing and then rejoining the heredity-carrying material of various organisms -- deoxyribonucleic acid, or DNA -- to make recombinant hybrids that carry some of the traits of two unrelated forms. It is contended that the value of such work is that it may create new medicines, vaccines, industrial chemicals or crops. The risk, some scientists claim, is that it could create unexpectedly dangerous new ailments or epidemics. Many scientists are of the opinion that exaggerations of the hypothetical hazards have gone far beyond any reasoned assessment. They take the position that the experience of the last four years, including many laboratory experiments, has shown no actual hazards.

 Recently the Supreme Court has summarized the limited role of the courts in determining whether the agencies have complied with NEPA.

 
The only role for a court is to insure that the agency has taken a 'hard look' at environmental consequences; it cannot 'interject itself within the area of discretion of the executive as to the choice of the action to be taken'. Kleppe v. Sierra Club, 427 U.S. 390, 410 n. 21, 49 L. Ed. 2d 576, 96 S. Ct. 2718 (1976) citing Natural Resources Defense Council v. Morton, 458 F.2d 827, 838, 148 U.S. App. D.C. 5, 16 (1972).

 The EIS does represent a "hard look" by NIH at recombinant DNA research performed in accordance with its guidelines. It appears that compliance with the NIH guidelines will insure that no recombinant DNA molecules will escape ...


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