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International Center For Technology Assessment v. Leavitt

January 8, 2007


The opinion of the court was delivered by: Ricardo M. Urbina United States District Judge

Document No. 24



This case comes before the court on the plaintiffs' motion for relief from judgment pursuant to Federal Rule of Civil Procedure 60(b)(2). The plaintiffs' suit challenges the defendants' decision not to regulate the commercialization of a genetically engineered ornamental fish ("GloFish") and the defendants' alleged failure to comply with the National Environmental Policy Act ("NEPA"), 42 U.S.C. § 4321 et seq., and the Endangered Species Act ("ESA"), 16 U.S.C. § 1531 et seq. On March 30, 2005, the court granted the defendants' motion to dismiss the case, and on March 8, 2006, the court denied the plaintiffs' motion to alter or amend the judgment pursuant to Federal Rule of Civil Procedure 59(e). The plaintiffs now claim to have newly discovered evidence that undermines the court's previous decisions. Because the plaintiffs lacked diligence in presenting the newly discovered evidence to the court, because some of the evidence is merely cumulative and impeaching, and because the newly discovered evidence is not of such a material and controlling nature that it will probably change the court's decision to dismiss the case, the court denies the motion.


A. Factual Background

The development and use of genetically engineered animals for food and ornamental purposes has become a fast-growing industry in recent years. Am. Compl. ¶ 31. Genetically engineered animals are subject to a wide array of regulatory authority. Mem. Op. (Mar. 8, 2006) ("Mem. Op.") at 1-2. Under the New Animal Drug Application ("NADA")*fn1 provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA"), the Food and Drug Administration ("FDA") is responsible for approving new animal drug products. 21 U.S.C. § 360b.

At least one manufacturer, Yorktown Technologies, L.P. ("Yorktown"), has developed a line of genetically engineered ornamental or pet fish which bears the trademarked name GloFish. Am. Compl. ¶ 35. The GloFish is a bright red fluorescent zebra fish that contains inserted genetic constructs from a sea coral, which cause the fish to glow under certain kinds of light. Id. Although GloFish are intended for use in home aquariums, the plaintiffs allege that they "could be put to other uses and readily enter the animal and human food chains through accidental or intentional releases." Id.

In the fall of 2003, Yorktown's CEO, Alan Blake, allegedly contacted one of the defendants, John Matheson, Program Officer at the FDA's Center for Veterinary Medicine, to ask about the FDA's views regarding GloFish. Mem. Op. at 4. In response to this inquiry, the FDA reviewed materials provided by Yorktown on its website and consulted directly with staff at the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture. Id. After considering the legal, scientific, and policy issues involved in the commercialization of GloFish, the FDA determined that regulation would be inappropriate. Id. Accordingly, on December 9, 2003, the FDA issued the following statement (the "GloFish Statement"):

Because tropical aquarium fish are not used for food purposes, they pose no threat to the food supply. There is no evidence that these genetically engineered zebra danio fish pose any more threat to the environment than their unmodified counterparts which have long been widely sold in the United States. In the absence of a clear risk to the public health, the FDA finds no reason to regulate these particular fish.

Id. at 3.

The plaintiffs dispute the veracity of the GloFish statement. Pls.' Mot. to Set Aside J. Under Rule 60(b) on the Basis of Newly Discovered Evidence ("Pls.' Mot.") at 3. They dispute, in particular, the statement that the FDA's decision not to regulate the GloFish was based on its consideration of the public health and scientific evidence. The plaintiffs contend that 14 items of "newly discovered evidence" demonstrate that the FDA decided not to regulate the GloFish because it mistakenly believed it did not have regulatory jurisdiction over the fish. Id.

B. Procedural History

On March 4, 2004, the plaintiffs, seeking declaratory and injunctive relief, filed an amended complaint. The amended complaint makes the claims that the FDA: (1) arbitrarily and capriciously distinguished between food and non-food uses in the GloFish Statement; (2) failed to review Yorktown's request for approval of the GloFish under the statutorily-prescribed standards; (3) failed to prepare an environmental impact statement ("EIS") or an environmental assessment prior to allowing the proposed commercialization of GloFish, in violation of NEPA; (4) failed to prepare an EIS or an environmental assessment with respect to genetically 3 engineered ornamental fish, and other genetically engineered animals generally, in violation of NEPA; (5) failed to prepare a biological assessment and failed to consult with the Fish and Wildlife Service ("FWS") before allowing the proposed ...

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