U.S. v. Blue Ribbon Smoked Fish, Inc., CV-01-3887 (CPS).

• Decision Date: 19 November 2001
• Docket Number: No. CV-01-3887 (CPS).,CV-01-3887 (CPS).
• Citation: 179 F.Supp.2d 30
• Parties: UNITED STATES of America, Plaintiff, v. BLUE RIBBON SMOKED FISH, INC., et alia, Defendants.
• Court: U.S. District Court — Eastern District of New York

179 F.Supp.2d 30

UNITED STATES of America, Plaintiff, v. BLUE RIBBON SMOKED FISH, INC., et alia, Defendants.

No. CV-01-3887 (CPS).

United States District Court, E.D. New York.

November 19, 2001.

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Charles S. Kleinberg, United States Attorney's Office, Civil Division, Brooklyn, NY, Allison M. Harnisch, Office of Consumer Litigation, U.S. Dept. of Justice, Washington, DC, for plaintiff.

Russell K. Statman, Plattsburgh, NY, for defendants.

MEMORANDUM AND ORDER

SIFTON, Senior District Judge.

The United States brings this action for injunction against defendants Blue Ribbon Smoked Fish, Inc. ("Blue Ribbon"), Jay A. Suttenberg ("Suttenberg"), Pablo Negron ("Negron"), and Susan Dozortsev ("Dozortsev") (collectively, the "defendants") under 21 U.S.C. § 332(a), the Federal Food, Drug and Cosmetic Act (the "Act" or "FDCA"). Specifically, the United States seeks to enjoin the defendants from violating 21 U.S.C. § 331(a) and (k) by introducing into interstate commerce food (1) that is adulterated within the meaning of the Act or (2) that will become adulterated after shipment.

Defendants Suttenberg, Negron, and Dozortsev (collectively, the "individual defendants") move pursuant to Fed.R.Civ.P. 12(b)(6) to dismiss the complaint against them in their individual capacities. The United States moves pursuant to Fed. R.Civ.P. 56 for summary judgment in its favor, enjoining the defendants from further violations of the FDCA on the ground that there are no material issues in dispute.

For the reasons set forth below, the individual defendants' motion is denied, and the United States' motion is granted.

BACKGROUND

The following facts are taken from the parties' submissions in connection with the present motions and are undisputed except as noted. For the purpose of the individual defendants' motion to dismiss the complaint, I assume the facts alleged in the complaint to be true. I will not consider any matters outside the pleadings submitted by either party and will not treat the individual defendants' motion as one for summary judgment. See Fed.R.Civ.P. 12(b)(6). For the purpose of plaintiff's motion for summary judgment, I assume that all uncontroverted Rule 56.1 factual assertions are not disputed. See Titan Indemnity Co. v. Triborough Bridge & Tunnel Authority, 135 F.3d 831, 835 (2d Cir.1998).

Blue Ribbon, a New York corporation, is engaged in preparing, processing, holding, and distributing a variety of seafood products, including brined fish, hot- and cold-smoked fish products, and seafood salads. It's facility is located at 5901 Foster Avenue, Brooklyn, New York (the "plant"). All three individual defendants work at the plant, are co-owners of Blue Ribbon, and are corporate officers responsible for plant operations. Suttenberg is president and co-owner of Blue Ribbon with ultimate authority over the plant's operations. According to the complaint, his responsibilities include food processing, plant sanitation, product distribution, and implementation of Hazard Analysis Critical Control Point ("HACCP") plans necessary for controlling food safety hazards.¹ Negron is vice president and co-owner of Blue Ribbon. He was previously Blue Ribbon's president, and as vice president he supervises the day-to-day operations of the plant, which includes overseeing the processing of the seafood, as well as the processes of fish thawing, brining, and smoking. Dozortsev is the secretary and treasurer of Blue Ribbon and a co-owner. Her duties, like those of Negron, include supervising the day-to-day operations of the plant, including overseeing the processing of the seafood, preparing HACCP plans, and monitoring sanitation controls.

Plaintiff alleges that the U.S. Food and Drug Administration ("FDA") and the New York State Department of Agriculture and Markets ("NYSDAM") have documented, throughout the last seven years, insanitary conditions at the facility as well as defendants' failure to establish and implement adequate HACCP plans necessary to control food safety hazards. The FDA and the NYSDAM have documented (1) numerous insanitary conditions at the plant; (2) defendant's failure to implement appropriate HACCP plans; and (3) the presence of Listeria Monocytogenes ("L.monocytogenes"), a bacteria that causes disease, in certain smoked fish products and in the plant environment.

Proper HACCP Plans

Seafood processors are required to establish and implement HACCP plans pursuant to 21 C.F.R. § 123.6(b). HACCP is a management system designed to prevent the occurrence of potential food safety problems. According to FDA regulations, a processor of fish and fishery products is required to assess biological, chemical, and physical hazards at all stages of processing, from production of the raw materials, to procurement and handling, manufacturing, distribution and consumption of the finished products. After assessing the health and safety risks that each particular food presents, the processor must determine necessary steps to control the identified risks. 21 C.F.R. § 123.6(a) & (b). A specific analysis must be done for each fish or fishery product, unless the food safety hazards, critical control points, critical limits, and procedures to be followed are identical for two or more fish products. 21 C.F.R. § 123.6(b)(2). The processor is then required to document these analyses in HACCP plans, as well as keep records to document the monitoring of the actual values and observations obtained when fish processing. 21 C.F.R. § 123.6(c)(7).

During the August 2000 inspection, the FDA found that Blue Ribbon failed to comply with FDA regulations regarding HACCP plans. According to the FDA's Establishment Inspection Report ("EIR"), the inspection team noted that "the firm lacked a written HACCP plan, a process schedule, and process monitoring records for a lot of brined and dried salmon pieces, removed from bones, used to produce a batch of cream cheese & lox." Blue Ribbon recalled this lot of cream cheese and lox² and promised to correct the HACCP deficiencies. In the follow-up inspection of January 2001, the FDA's EIR again noted HACCP deficiencies, stating, in part:

The firm processes cold smoked Nova Salmon with an incomplete written HACCP Plan, incomplete Monitoring Records and Verification Procedures that do not document the accuracy of temperature measuring devices or Salometers used in the brining operation. There is no verification of raw materials (incoming fish) containing levels of microorganisms that will not produce food poisoning or other disease in humans, and the firm operates with inadequate HACCP controls. There is no written HACCP Plans for Nova Salmon Bits (produced from pieces of salmon removed from bones) or smoked Sea Bass.

The EIR detailed the specific deficiencies that the inspection team observed in the HACCP plans. The following problems were identified with the cold smoked Nova salmon HACCP plan: the plan was signed but not dated, as required by 21 C.F.R. 123.6(d); it erroneously listed scombrotoxin formation as a food safety hazard relating to salmon production; there was no critical limit for internal fish temperature; no time was specified for thawing frozen fish; no procedure was included for monitoring brine solution or fish temperature during brining; it was inconsistent with the firm's written procedure for brining;³ there was no procedure to check the accuracy of thermometers, salometers, thermostats; and there was inadequate monitoring of critical control points. The EIR also detailed the lack of HACCP plans for Nova salmon bits and noted that this deficiency had been brought to Blue Ribbon's attention during the August 2000 inspection. It was also observed that Blue Ribbon did not have a written HACCP plan for smoked sea bass. These deficiencies were discussed with Suttenberg and Dozortsev.

Defendants do not dispute the FDA findings that the HACCP plans were inadequate or non-existent at the time of these inspections. The defendants maintain that, as of now, Blue Ribbon has implemented an effective HACCP plan, which the company now follows.

Insanitary Plant Conditions

Inspections of the plant were conducted in 1994, 1995, 1996, 1999, 2000, and 2001. According to Jerome G. Woyshner, Director, Investigations Branch, New York District, Northeast Region of the FDA, Department of Health and Human Services ("Woyshner"), the FDA conducted the most recent plant inspection from January 17 to 26, 2001. The January 2001 inspection revealed the following insanitary conditions: old seafood product residue on food contact surfaces; mold in the cooler, freezer, and ceiling of the slicing and packing room; a plastic dividing curtain that touched the floor and came into contact with fish; liquid dripping onto seafood from other seafood stored above; and old dripping product residue on the walls and fan shrouds in the cold smoking/drying room. The inspection found the inadequate cleaning and sanitizing processes, including a failure to adequately sanitize and wash cutting boards, knives, and slicing machine. The inspection also revealed employees touching unclean surfaces and then touching ready-to-eat fish without sanitizing their gloves, wearing street cloths in the processing areas without protective coverings, eating and drinking in the processing areas, inadequate hand washing and sanitizing, and wearing of unrestrained hair and beards. The FDA also found that the plant's construction was not designed to prevent bacterial contamination and filth and that there were inadequate doors or barriers between the slicing and packing room and the garage and toilet, lack of control over foot traffic and product flow to prevent cross-contamination of the finished ready-to-eat product and that surfaces were in disrepair making adequate cleaning impossible.

In August 2000, the FDA conducted two inspections and found insanitary plant conditions. For instance, the ceiling...