International Center for Tech. Assess. v. Thompson

• Decision Date: 08 March 2006
• Docket Number: Civil Action No. 04-0062 (RMU).
• Citation: 421 F.Supp.2d 1
• Parties: INTERNATIONAL CENTER FOR TECHNOLOGY ASSESSMENT et al., Plaintiffs, v. Tommy THOMPSON, Secretary, U.S. Department of Health and Human Services et al., Defendants.
• Court: U.S. District Court — District of Columbia

Page 1

421 F.Supp.2d 1

INTERNATIONAL CENTER FOR TECHNOLOGY ASSESSMENT et al., Plaintiffs, v. Tommy THOMPSON, Secretary, U.S. Department of Health and Human Services et al., Defendants.

Civil Action No. 04-0062 (RMU).

United States District Court, District of Columbia.

March 8, 2006.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

Joseph Mendelson, III, International Center for Technology Assessment, Peter T. Jenkins, International Center for Technology Assessment & Center for Food Safety, Washington, DC, for Plaintiffs.

Suzette A. Smikle, U.S. Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION

URBINA, District Judge.

DENYING THE PLAINTIFFS' MOTION TO ALTER OR AMEND JUDGMENT

I. INTRODUCTION

This matter comes before the court on the plaintiffs' motion to alter or amend judgment. The plaintiffs' suit challenges the defendants' decision to allow unregulated commercialization of a genetically engineered ornamental fish 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. The plaintiffs now request that the court reverse its decision granting the defendants' motion to dismiss. Because this court did not commit a clear error in dismissing the amended complaint, the court declines to alter or amend judgment.

II. BACKGROUND

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. Defs.' Mot. to Dismiss at 6-9. Under the New Animal Drug Application ("NADA")¹ 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, hereinafter referred to by its 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. Defs.' Mot. to Dismiss at 11; Pls.' Opp'n to Defs.' Mot. to Dismiss at 4. In response to this inquiry, the FDA reviewed materials provided by Yorktown to the public through its website and consulted directly with staff at the Animal and Plant Health Inspection Service of the USDA. Defs.' Mot. to Dismiss at 12; Pls.' Opp'n to Defs.' Mot. to Dismiss at 4-5. After considering the legal, scientific, and policy issues involved in the commercialization of GloFish, the FDA determined that regulation would be inappropriate. Pls.' Opp'n to Defs.' Mot. to Dismiss at 5; Defs.' Mot. to Dismiss at 12. 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.

Am. Compl. ¶ 38; Defs.' Mot. to Dismiss at 12. The next day, Yorktown announced on its website that in response to the FDA's decision not to regulate GloFish and due to unprecedented demand, limited numbers of GloFish would be made available immediately, with nationwide sales commencing shortly thereafter. Am. Compl. ¶ 40.

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 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 commercialization of GloFish, in violation of the ESA; and (6) violated the ESA through its actions with respect to genetically engineered ornamental fish, and other genetically engineered animals generally. Am. Compl. ¶¶ 56-79.

On April 19, 2004, the defendants responded to the complaint by filing a motion to dismiss. On March 30, 2005, the court granted the defendants' motion to dismiss. The court dismissed the first two claims (the "NADA claims") because the FDA's decision not to regulate GloFish is committed to the agency's discretion. Mem. Op. (Mar. 30, 2005) ("Mem.Op.") at 17-25. The court dismissed the third and fourth claims (the "NEPA claims") because the FDA has not taken a major federal action as required by NEPA. Id. at 25-29. Finally, the court dismissed the fifth and sixth claims (the "ESA claims") because the FDA has not engaged in agency action as required by ESA. Id. at 29-32. The plaintiffs subsequently filed a motion to alter or amend the court's judgment. Pls.' Mot to Alter or Amend Judgment ("Pls.' Mot"). The court now turns to that motion.

III. ANALYSIS

A. Standard of Review for Motion to Alter or Amend

Federal Rule of Civil Procedure 59(e) provides that a motion to alter or amend a judgment must be filed within 10 days of the entry of the judgment at issue. FED.R.CIV.P. 59(e); see also Mashpee Wampanoag Tribal Council Inc. v. Norton, 357 U.S.App. D.C. 422, 336 F.3d 1094, 1098 (D.C.Cir.2003). While the court has considerable discretion in ruling on a Rule 59(e) motion, the reconsideration and amendment of a previous order is an unusual measure. Firestone v. Firestone, 76 F.3d 1205, 1208 (D.C.Cir.1996) (per curiam); McDowell v. Calderon, 197 F.3d 1253, 1255 (9th Cir.1999).

Rule 59(e) motions "need not be granted unless the district court finds that there is an intervening change of controlling law, the availability of new evidence, or the need to correct a clear legal error or prevent manifest injustice." Ciralsky v. Cent. Intelligence Agency, 355 F.3d 661, 671 (D.C.Cir.2004) (quoting Firestone, 76 F.3d at 1208). Moreover, "[a] Rule 59(e) motion to reconsider is not simply an opportunity to reargue facts and theories upon which a court has already ruled," New York v. United States, 880 F.Supp. 37, 38 (D.D.C.1995), or a vehicle for presenting theories or arguments that could have been advanced earlier. Kattan v. Dist. of Columbia, 995 F.2d 274, 276 (D.C.Cir.1993); W.C. & A.N. Miller Cos. v. United States, 173 F.R.D. 1, 3 (D.D.C. 1997).

B. The Court's Dismissal of the NADA Claims is Not in Clear Error

The plaintiffs' first two claims allege that the FDA improperly refused to regulate the GloFish, and that the FDA's failure to assert regulatory authority over the GloFish violates the NADA provisions of the FDCA. The court dismissed the two claims, argued in the alternative, because the FDA's "enforcement decisions relating to unapproved new animal drug products are discretionary and are not subject to judicial review under the APA." Mem. Op. at 18.

1. The FDA Properly Refused to Assert Regulatory Jurisdiction Over the GloFish

The plaintiffs' first claim is that the FDA arbitrarily and capriciously denied regulatory jurisdiction over the GloFish. Am. Compl. ¶¶ 39, 58. In particular, the plaintiffs allege that the FDA "arbitrarily and capriciously advised Yorktown that no NADA was mandated" because the FDA mistakenly believed it lacked jurisdiction to regulate the GloFish. Pls.' Mot. at 4. The court dismissed the plaintiffs' first claim because this is not a case "where the agency refuses to institute proceedings based solely on the belief that it lacks jurisdiction."² Mem. Op. at 22 (quoting Balt. Gas & Elec. v. Fed. Energy Reg. Comm'n, 252 F.3d 456, 460 (D.C.Cir. 2001)).

The plaintiffs' motion to alter or amend judgment simply reiterates the argument that the FDA refused to assert regulatory authority over the GloFish based on the FDA's mistaken belief that it lacks jurisdiction. The plaintiffs, moreover, do not present any new factual evidence to indicate clear error in the court's original conclusion that the FDA was not acting on the basis of a mistaken belief as to its regulatory jurisdiction.³ Indeed, the evidence available, the GloFish statement, states that the FDA "finds no reason to regulate" GloFish. Am. Compl. ¶ 38. Nowhere does the statement indicate that the FDA believed it did not have the authority to regulate GloFish. As the court previously stated, the "FDA is simply exercising its discretion not to take enforcement actions against these particular fish." Mem. Op. at 22. In short, the plaintiffs do not present any new evidence indicating that the court's conclusion that the FDA was not acting under the mistaken belief that it lacked jurisdiction is incorrect. New York, 880 F.Supp....