United States District Court, N.D. Illinois, Eastern Division
MEMORANDUM OPINION AND ORDER
MATTHEW F. KENNELLY, District Judge.
Eastern Seafood, Inc. processes and distributes fish products. Mario Falco is Eastern's president and sole owner. In July 2002, the federal government sued Eastern and Falco, alleging that they were violating the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 331(k), by causing adulterated articles of food to be introduced into interstate commerce. In August 2002, the Court entered a consent decree of permanent injunction, which, among other things, permanently restrained and enjoined defendants "from doing or causing to be done, directly or indirectly, any act that violates 21 U.S.C. § 331(k) by causing food to become adulterated within the meaning of 21 U.S.C. § 342(a)(4) after shipment in interstate commerce." Consent Decree of Permanent Inj. § VIII. Now, nearly thirteen years later, defendants have moved to vacate the consent decree, arguing that its intent has been achieved and that its continued enforcement is unnecessary and oppressive. The government opposes the motion.
For the reasons set forth below, the Court denies defendants' motion to vacate. But given the decree's already long life, the Court is inclined to modify it to include a "sunset" provision allowing the court to terminate it if defendants are in continuous compliance for a period of three years. The Court orders the parties to show cause why such a modification would be inappropriate.
In its complaint, filed in 2002, the government alleged that defendants had failed to develop and implement a Hazard Analysis and Critical Control Point (HACCP) plan for their fresh scombroid-forming fishery products (scombrotoxin fish products). According to the government, 21 C.F.R. § 123.6 required defendants to establish and implement a HACCP plan for their scombrotoxin fish products and to maintain a recordkeeping system to document the monitoring of critical control points for such products. Because defendants failed to establish and implement an HACCP plan and failed to maintain the proper recordkeeping system, the food they produced was adulterated within the meaning of 21 U.S.C. § 342(a)(4), and thus defendants violated 21 U.S.C. § 331(k) by causing their articles of food to become adulterated while held for sale after shipment in interstate commerce.
In August 2002, the Court entered the decree. Among other things, the decree:
restrained and enjoined defendants from processing scombrotoxin fish products unless and until an independent HACCP expert prepared a HACCP plan that defendants implemented to the FDA's satisfaction;
required defendants to implement a HACCP plan and maintain a HACCP control program for scombrotoxin once defendants' scombrotoxin fish products operations resumed;
permitted the FDA to make inspections of defendants' facilities without prior notice and when the FDA deems it necessary;
required defendants to pay the costs of the FDA's inspections conducted pursuant to the decree; and
restrained and enjoined defendants "from doing or causing to be done, directly or indirectly, any act that violates 21 U.S.C. § 331(k) by causing food to become adulterated within the meaning of 21 U.S.C. § 342(a)(4) after shipment in interstate commerce."
Decree § VIII. Under the decree, if the FDA determines that defendants have violated the decree, the Act, or FDA regulations, it may order cessation of defendants' operations or recall of defendants' products. Any decisions the FDA makes pursuant to the decree are considered final and reviewable by the Court only under an "arbitrary and capricious" standard.
The decree itself does not contain a "sunset" provision, but internal FDA guidelines provide, at least currently, that FDA may agree not to oppose a motion to vacate a consent decree injunction if the following conditions are met: (1) the agency has recent evidence that the defendant is in compliance with the Act, applicable regulations, and the decree; (2) the defendant has remained in "continuous compliance" for the "life of the sunset provision (virtually always five years)"; and (3) the defendant has provided FDA with an opportunity to consider whether to object to the motion. U.S. Food & Drug Admin., Regulatory Procedures Manual § 6-2-16 (2011), available at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManua l/UCM074317.pdf (last visited July 28, 2015). The government contends that none of these conditions has been met here. It objects to defendants' motion on the ground that defendants have not been in continuous compliance with the Act or the decree for the past five years.
Defendants contend that, during the decree's lifetime, they have been cooperative and compliant with the Act, FDA regulations, and the decree and that the FDA has not found contamination in any of their products and has not cited them with any official "violations" of the Act. As section IV of the decree required of defendants if they wanted to resume processing scombrotoxin fish products, they selected a HACCP expert who revised their HACCP plan, which the FDA ultimately approved and defendants implemented in 2002. Defendants note that in addition to implementing their upgraded HACCP plan, they have made upgrades to their processing facility and equipment to ensure compliance with the Act. These upgrades include: (1) hanging water hoses from the ceiling to prevent contact with food while not in use, (2) connecting waters sources to "backflow prevention devices" to prevent the formation of scombrotoxin bacteria, (3) using new digital temperature monitoring ...