MEMORANDUM OPINION
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; Pis.’ Opp’n to Defs.’ Mot. to Dismiss *5 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; Pis.’ 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. Pis.’ 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. Pis.’ Mot to Alter or Amend Judgment (“Pis.’ 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
*6
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,
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,
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. Pis.’ 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 con-
*7
elusion 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,
2. The Plaintiffs Fail to Show Yorktown Submitted a NADA
The court also rejected the plaintiffs’ second claim, which alleges, in the alternative, that Yorktown Technologies did submit a NADA, and that the FDA subsequently reviewed the NADA under the wrong regulatory standard. Mem. Op. at 17-18. The plaintiffs move this court to alter or amend the judgment by arguing that the court’s dismissal is based on its assumption that Yorktown Technologies did not submit a NADA. 4 The plaintiffs argue that the court was required to treat their allegation that Yorktown Technologies submitted a NADA as true for the purposes of analyzing the defendants’ motion to dismiss. Pis.’ Mot. at 2-3.
Because subject-matter jurisdiction focuses on the court’s power to hear the claim, the court must give the plaintiffs’ factual allegations closer scrutiny when resolving a Rule 12(b)(1) motion than would be required for a Rule 12(b)(6) motion for failure to state a claim.
Macharia v. United States,
Assuming
arguendo
that Yorktown submitted a NADA, the court still declines to alter or amend the judgment because the FDA has the discretion to decline to take any enforcement action once a NADA is approved.
5
The PDA’s decisions not to prosecute or enforce are presumptively unreviewable by the court because such decisions are committed to the agency’s discretion.
Jerome Stevens Pharma., Inc. v. FDA,
C. The Court’s Dismissal of the NEPA Claims is Not in Clear Error
The plaintiffs also move the court to alter its dismissal of their allegations that the defendants failed to comply with the NEPA requirements. The plaintiffs contend that two FDA actions amount to “major” federal actions triggering NEPA. First, in their third claim, the plaintiffs assert that the defendants’ refusal to regulate GloFish constitutes major federal action. Am. Compl. ¶¶ 64-67. Second, in their fourth claim, the plaintiffs assert that the defendants’ broader refusal to regulate genetically engineered ornamental fish is major federal action triggering NEPA requirements. Id. ¶¶ 68-73. The court dismissed both of these claims finding that the FDA’s activities did not amount to major federal action. Mem. Op. at 23.
NEPA requires federal agencies to prepare an EIS if the agency plans to undertake a “major” federal action “significantly affecting the quality of the human environment.” 42 U.S.C. § 4332(C). If the agency has not engaged in a major federal action, NEPA requirements do not apply.
Macht v. Skinner,
*9 1. The FDA’s Refusal to Regulate GloFish is Not a Major Federal Action
The plaintiffs allege this court clearly erred in dismissing the third claim because the court looked beyond the pleadings in ruling against them. Pis.’ Mot. at 6. Specifically, the plaintiffs allege that the court’s dismissal of their third claim was based on the court’s determination that no NADA was submitted. Because the plaintiffs’ argument is based on a misunderstanding of the court’s reasoning and of the applicable law, the court declines to alter its decision to dismiss the plaintiffs’ third claim.
The court, in ruling on a motion to dismiss, need not accept “legal conclusions cast as factual allegations.”
Warren v. Dist. of Columbia,
According to the plaintiffs, the defendants have engaged in a “major federal action” triggering NEPA compliance because they have “authorized the sale of a genetically engineered fish that has the potential to significantly impact public health, animal health, and the environment.” Pis.’ Opp’n to Defs.’ Mot. to Dismiss at 31. But, the FDA never authorized the sale of GloFish. Rather, the agency declined to initiate enforcement proceedings against the GloFish manufacturer. The FDA’s decision not to regulate GloFish is not an agency action, but rather, an agency inaction. In addition, the FDA has not made an “irreversible and irretrievable commitment of resources” to the regulation of GloFish or the regulation of genetically engineered animals in general that would trigger NEPA’s requirements.
Id.
at 174. To the contrary, the FDA’s GloFish statement indicates that no resources are being committed to regulate GloFish because the GloFish Statement explicitly states that the FDA “finds no reason to regulate these particular fish.”
Alliance for Bio-Integrity,
2. The FDA’s Refusal to Regulate Genetically Engineered Animals is Not a Major Federal Action
The court dismissed the plaintiffs’ fourth claim, which alleges that the FDA’s failure to prepare an EIS with respect to genetically engineered animals violates the NEPA, because the court concluded that the FDA did not engage in a major federal action. Mem. Op. at 23. In moving the court to alter or amend its judgment, the plaintiffs charge the court with committing clear error for failing to interpret the facts liberally in their favor and for misapplying NEPA regulations. Pis.’ Mot. at 10. The court’s conclusion, however, remains unchanged because the plaintiffs do not present any new evidence or arguments showing that the court committed a clear error.
The court must “treat the complaint’s factual allegations—including mixed questions of law ,and fact—as true and draw all reasonable inferences therefrom in the plaintiffs favor.”
Macharia,
D. The Court’s Dismissal of the ESA Claims is Not in Clear Error
The court dismissed the plaintiffs’ fifth and sixth claims because they failed to sufficiently allege an agency action triggering ESA compliance. Mem. Op. at 29. The plaintiffs now argue that the court committed clear error in concluding that the FDA’s actions concerning GloFish and other genetically engineered animals do not trigger ESA requirements. Pis.’ Mot. at 6. Because the plaintiffs have not presented any new arguments or evidence showing that the court committed a clear error, the court denies the plaintiffs’ motion to alter or amend the dismissal of the fifth and sixth claims. 7
To trigger ESA requirements, an agency must have engaged in an agency action. 16 U.S.C. § 1536(a)(2); 50 C.F.R. § 402.03 (stating that the consultation requirement in Section 7 of the ESA is limited to agency “action in which there is discretionary Federal involvement or control”);
Natural Res. Def. Council v. Houston,
The plaintiffs’ motion asserts that the court’s reasoning in dismissing their fifth and sixth claims is based on facts extraneous to the amended complaint. Pis.’ Mot. at 6. Specifically, the plaintiffs allege that *11 the court’s ruling is based on its determination Yorktown did not submit a NADA. Id. at 6. The court, however, did not base its ruling on this determination. Mem. Op. at 29-30.
The court concluded that the FDA’s actions did not constitute agency action because the plaintiffs failed to allege that the defendants engaged in any type of action. Mem. Op. at 30. As the court stated, the FDA simply decided not to engage in enforcement activity. Mem. Op. at 30. The court, furthermore, was not required to accept the plaintiffs’ legal conclusion that the alleged inaction constitutes an agency action.
Warren,
IV. CONCLUSION
For the foregoing reasons, the court denies the plaintiffs’ motion to alter or amend its ruling granting the defendants’ motion to dismiss. An order consistent with this Memorandum Opinion is separately and contemporaneously issued this 8th day of March, 2006.
Notes
. "The Food, Drug and Cosmetic Act ('FDCA') provides that any new animal drug is considered unsafe prior to receiving FDA approval for its intended use. 21 U.S.C. § 360b(a)(l)(A). To secure such approval, the FDCA requires the applicant to file a New Animal Drug Application ('NADA') that includes information demonstrating both the safety and the efficacy of the drug.
Id.
§ 360b(d)(l)(A).”
A.L. Pharma, Inc. v. Shalala,
. Generally, an agency’s decision not to prosecute or enforce is committed to the agency's discretion and courts presumptively do not have subject-matter jurisdiction to review actions committed to agency discretion.
Heckler v. Chaney,
. The plaintiffs' only argument with respect to the dismissal of the first claim is a one-sentence statement that it was an error for this court to conclude that the plaintiffs will not be able to prove that the FDA believed it lacked jurisdiction. Pis.' Mot. to Alter or Amend Judgment (“Pis.' Mot.”) at 4.
. The court reasoned that because Yorktown did not submit a NADA, the defendants’ decision not to regulate the FDA was "simply a decision not to exercise enforcement authority.” Mem. Op. at 21. The court concluded that such a decision is beyond the reach of judicial review. Id. The plaintiffs do not dispute the court's legal conclusion. Rather, the plaintiffs assert that Yorktown submitted a NADA and that the defendants arbitrarily and capriciously approved the NADA.
. The defendants make this precise argument in their opposition to the plaintiffs’ motion. Defs.’ Opp’n to Pis.’ Mot. to Alter or Amend Judgment at 5 n. 4. The plaintiffs’ reply does not make any arguments regarding this court’s ability to review the FDA’s decision not to take an enforcement action.
. The plaintiffs also allege that the court committed clear error in applying the NEPA regulations. Pis.' Mot. at 9. Although the plaintiffs charge the court with ignoring 40 C.F.R. § 1502.4(b), the plaintiffs did not include this argument in their opposition to the defendants’ motion to dismiss. District courts are not "required to unearth theories and precedents not cited by a party.”
Bucheit v. Palestine Liberation Org.,
. The court notes that a motion to alter or amend judgment "is not simply an opportunity to reargue facts and theories upon which a court has already ruled.”
New York v. United States,
