Mack v. Califano

No. 77-916 (D.D.C. February 23, 1978)

The court denies plaintiff's motion for a preliminary injunction to prevent defendants from carrying out experimental research involving recombinant DNA in certain strains of bacteria. Under a prior stipulation, proceedings were stayed until a final environmental impact statement (EIS) was prepared, and the EIS was completed on November 28, 1977. Plaintiff alleged that the experiments threaten the environment through accidental release of mutant bacteria, that the requirements of the National Environmental Policy Act have not been fully met, and that this type of research has been classified as "prohibited" by the Department of Health, Education and Welfare. Defendants argued that the EIS was adequate and that the experiments are consistent with National Institutes of Health guidelines which reflect the cautious manner in which the scientific community has considered the recombinant DNA technology. Furthermore, defendants argued that plaintiff misunderstands the nature of the experimental material and procedures. The court finds that the EIS represents a "hard look" by the agency at the possible environmental consequences of the experiment, as required by Kleppe v. Sierra Club, 6 ELR 20532. The record shows that the potential risks have been carefully considered and the necessary precautions have been taken to protect the environment. Furthermore, important scientific information would be delayed if a preliminary injunction were granted.

Counsel for Plaintiff
Ferdinand J. Mack
17 W. Jefferson St., Rockville MD 20850
(301) 279-2230

Counsel for Defendants
David Schlee, Ass't U.S. Attorney
Room 3600-E, U.S. Courthouse, 3d & Constitution Ave. NW, Washington DC 20001
(202) 426-7511

[8 ELR 20347]

Smith, J.:

Opinion

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.

On May 31, 1977 plaintiff, an infant resident of Frederick, Maryland, filed a motion for temporary restraining order and preliminary injunction to enjoin defendants from undertaking the experiments or constructing facilities at Fort Detrick to be used for the research. On July 18th a stipulation was entered into by the parties staying all proceedings pending finalization by the defendants of an environmental impact statement and providing for 30-days notice to plaintiff of any experiments to be conducted at Fort Detrick after such finalization. In accordance with the stipulation, defendants advised plaintiff that an environmental impact statement (EIS) became final on November 28, 1977 when the Council on Environmental Quality published notice of its receipt in the Federal Register. Plaintiff contends that the statement does not comply with the requirements of the National Environmental Policy Act (NEPA), 42 U.S.C. § 4332(2)(C) and other statutes.

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 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.

Counsel for the American Society for Microbiology states that the weight of scientific opinion now considers that recombinant DNA research in accordance with the NIH guidelines will not have adverse environmental or public health consequences. He contends that the present guidelines are more conservative than necessary and that certain restrictions in these guidelines could be safely modified. He further asserts that these guidelines are not in fact the very guidelines of HEW classified as "prohibited" as was asserted by plaintiff. In the opinion of the Society, the proposed Fort Detrick experiment will specifically advance the public interest and present no risk of harm to the environment.

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 [8 ELR 20348] 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 [6 ELR 20532, 20537 n.21] (1976) citing Natural Resources Defense Council v. Morton, 458 F.2d 827, 838, 148 U.S. App. D.C. 5, 16 [2 ELR 20029, 20034] (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 ensure that no recombinant DNA molecules will escape from the carefully controlled laboratory to the environment.

Plaintiff requested an extension of time to furnish additional evidence. He submitted supplemental affidavits from four of his previous affiants which reaffirmed their previously expressed opinions. None of the affidavits established that the experiment is likely to cause harm to human health or to the environment. The Recombinant DNA Research Guidelines represent an effort by many scientists to evaluate the hazards and provide safe methods for their control. The record reflects that NIH has carefully considered the potential risks of this experiment under the guidelines and has taken the necessary precautions.

The experiment is designed to provide important and needed information on the possibilities of recombinant DNA technology. Important scientific information relative to the possibilities of this technology would be delayed if a preliminary injunction were granted.

Accordingly, plaintiff's motion for a preliminary injunction is denied. Defendants' motion to vacate stay is granted.

Order

Upon consideration of plaintiff's motion for preliminary injunction, defendants' memorandum in opposition thereto, the brief of the American Society for Microbiology Amicus Curiae, affidavits, exhibits, supplemental memoranda submitted by the parties, and after oral argument, it is by the court this 23rd day of February 1978

ORDERED that plaintiff's motion for preliminary injunction is denied, and it is further

ORDERED that defendants' motion to vacate stay is granted.