United States District Court, E.D. New York
PROPOSED ORDER OF PERMANENT INJUNCTION
ROSLYNN R. MAUSKOPF, District Judge.
Plaintiff, the United States of America, having filed a Complaint for Injunction against N.Y. Fish, Inc., a corporation; New York City Fish, Inc., a corporation; and Maxim Kutsyk, Pavel Roytkov, Leonid Staroseletsky, and Steven Koyfman, individuals (collectively, "Defendants"), a Motion for Preliminary Injunction with a supporting memorandum of law, the declarations of (1) Ronald M. Pace, Director of the New York District Office of the U.S. Food and Drug Administration ("FDA"); (2) Mary E. Losikoff, Consumer Safety Officer, Office of Food Safety, FDA's Center for Food Safety and Applied Nutrition ("CFSAN"); and (3) Christine E. Keys, Microbiologist, CFSAN's Office of Regulatory Science; a reply memorandum in further support of its motion for preliminary injunction; a declaration in advance of trial from Peter M. Trunk, Consumer Safety Officer, Director of FDA's New York District Office; a second declaration in advance of trial from Mary Losikoff; and this Court having considered such documents, all documents filed by Defendants, and the arguments and live testimony at the hearing on July 9 and 10, 2013 consolidating the United States' Motion for Preliminary Injunction and request for a permanent injunction in its Complaint for Injunction; and it appearing that Defendants are violating the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. ("the Act"), and unless restrained by order of this Court, may continue to violate the Act,
IT IS HEREBY ORDERED that:
I. This Court has jurisdiction over the subject matter and over all parties to this action pursuant to 21 U.S.C. § 302.
II. The Complaint for Injunction states a claim for relief against Defendants under the Act.
III. The United States has succeeded on the merits of its claims that Defendants violate the Act, 21 U.S.C. § 331(a), by introducing, or delivering for introduction, into interstate commerce articles of food that are adulterated within the meaning of 21 U.S.C. § 342(a)(4), and the public interest weighs heavily in favor of granting the permanent injunctive relief sought by the United States.
IV. The United States has succeeded on the merits of its claim that Defendants violate the Act, 21 U.S.C. § 331(k), by causing articles of food to be adulterated within the meaning of 21 U.S.C. § 342(a)(4) while such articles are held for sale after shipment of one or more ingredients in interstate commerce, and the public interest weighs heavily in favor of granting the permanent injunctive relief sought by the United States.
V. Upon entry of this Order, Defendants and each and all of their directors, officers, agents, employees, representatives, successors, assigns, heirs, attorneys, and any persons in active concert or participation with any of them (including individuals, directors, corporations, subsidiaries, affiliates, and partnerships) are hereby restrained and enjoined, under the provisions of 21 U.S.C. § 332(a) and the inherent equitable authority of this Court, from directly or indirectly receiving, preparing, processing, packing, holding, and distributing articles of food, at or from their facility located at 738 Chester St., Brooklyn, New York XXXXX-XXXX (the "Chester Street Facility"), and/or any other location(s) at or from which Defendants, now or in the future, receive, process, prepare, pack, hold, or distribute articles of food, unless and until:
A. Defendants retain, at their expense, an independent laboratory (the "laboratory") having no personal or financial ties (other than the retention agreement) to Defendants or their families, which is qualified to collect product and environmental samples from within the Chester Street Facility and analyze those samples for the presence of Listeria monocytogenes (" L. mono ") using a method that is acceptable to the FDA. Defendants shall notify FDA in writing immediately upon retaining such laboratory and shall provide FDA a copy of the service contract. Such service contract shall contain provisions, acceptable to FDA, for regular environmental and finished product sample collection and analyses, including how and where to sample, the number and frequency of samples to be collected, and the methods of analyses, in accordance with the Listeria Monitoring Program discussed in paragraph V(C) below;
B. Defendants retain, at their expense, an independent expert(s) (the "Sanitation Expert") having no personal or financial ties (other than the retention agreement) to Defendants or their families, and who, by reason of background, education, training, and experience, is qualified to develop a Listeria Monitoring Program, to inspect the Chester Street Facility, and to determine whether the methods, facilities, and controls are operated and administered in conformity with the Act, its implementing regulations, and this Order. Defendants shall notify FDA in writing of the name(s) and qualifications of the Sanitation Expert as soon as they retain such expert;
C. Defendants' Sanitation Expert, in consultation with the laboratory, after review of all FDA observations from 2006 to present, develops a written Listeria Monitoring Program, which shall include, at a minimum, the following:
(1) An effective written sanitation control program that establishes adequate methods, facilities, and controls for receiving, preparing, processing, packing, holding and distributing articles of food to minimize the risk of introducing L. mono, other pathogenic organisms, and filth into Defendants' food, and to ensure that foods are not adulterated within the meaning of 21 U.S.C. § 342(a). Such methods, facilities, and controls shall include, but shall not be limited to, thoroughly cleaning, sanitizing, renovating, and rendering the Chester Street Facility and all equipment therein suitable for use in receiving, preparing, processing, packing, holding, and distributing articles of food to prevent such articles from becoming adulterated, and instituting standard sanitation operating procedures ("SSOPs") to ensure that the Chester Street Facility and equipment therein are continuously maintained in a sanitary condition. An effective written sanitation control program during the period of time when Defendants are enjoined under Paragraph V shall include completely disassembling all of the equipment and thoroughly cleaning and sanitizing the disassembled equipment by soaking the equipment parts in quaternary ammonia overnight, applying steam to larger pieces of equipment after they have been thoroughly cleaned and sanitized, and fogging rooms with a sanitizer solution;
(2) A written employee training program (in English, Spanish, Russian, and any other language that is necessary to convey the substance of the training program to the employees) that includes, at a minimum, instructions on sanitary food handling techniques and documentation that each employee has received such training. The employee training program shall include, at a minimum, basic training for all employees on the importance of Listeria controls and their role in Listeria control strategies, training for all employees who handle or work in exposed finished product areas to ensure that they understand how to prevent cross-contamination of product, and training for all employees who conduct cleaning and sanitation tasks or activities to ensure that they understand the sanitation procedures necessary to reduce or eliminate Listeria in the plant. Defendants' Sanitation Expert shall ensure that each employee fully understands the substance of the employee training program;
(3) An effective program for environmental monitoring and testing of the Chester Street Facility to ensure that such organisms as Listeria species (" L. spp. ") are controlled, and that the pathogen L. mono is not present within the facility. Environmental monitoring shall include, but not be limited to, collecting swab samples from food-contact surfaces, equipment, and other environmental sites throughout the Chester Street Facility (where the raw ingredients, in-process, and finished articles of foods are received, prepared, processed, packed, held, and/or distributed, and common areas that could be reservoirs for cross-contamination), and analysis of collected samples, in a manner acceptable to FDA. Defendants shall ensure that the results of all analyses conducted pursuant to this paragraph are sent to FDA within two (2) calendar days after receipt by Defendants; and
(4) A written plan for remedial action, which is acceptable to FDA, should L. spp. or L. mono be detected;
D. Defendants assign continuing responsibility for the operation of the Listeria Monitoring Program discussed in Paragraph V(C) above to a person (or persons), who, by reason of background, experience, or education, is competent to maintain the Chester Street Facility in a sanitary condition, coordinate with the laboratory, and implement any necessary remedial action(s), and provide such person(s) with the authority to achieve the necessary corrections;
E. Defendants make versions of the Listeria Monitoring Program (in English, Spanish, Russian, and any other language necessary to convey the substance of the Listeria Monitoring Program to their employees) available and accessible to all their employees;
F. FDA approves, in writing, the Listeria Monitoring Program discussed in paragraph V(C) above;
G. The Sanitation Expert conducts a comprehensive inspection of the Chester Street Facility and the methods and controls used to receive, prepare, process, pack, hold, and distribute foods to determine whether the Defendants have effectively implemented all corrections and are operating in compliance with this Order, the Act, and its implementing regulations. The Sanitation Expert shall submit all findings to Defendants and FDA concurrently, within ten (10) business days after completion of the inspection;
H. Defendants retain a person or persons (the "HACCP Expert" or "HACCP Experts") who is/are without any personal or financial ties (other than the consulting agreement) to Defendants or their families, and who by reason of background, experience, and education, is qualified to:
(1) Conduct hazard analyses to develop adequate HACCP plans for the processing of each type of fish and fishery product Defendants intend to process, as required by 21 C.F.R. § 123.6(a)-(c);
(2) Verify the adequacy of Defendants' HACCP plans, as required by 21 C.F.R. § 123.8;
(3) Develop adequate SSOPs specific to Defendants, as required by 21 C.F.R. § 123.11;
(4) Evaluate Defendants' monitoring of key sanitation conditions and practices, as set forth ...