United States District Court, D. Maine
For Defendants: IRA J. (JOEL) FRANTZMAN, Individually, LAUREN E. HANDEL, pro hac vice Foscolo & Handel PLLC, RICHARD SILVER Lanham, Blackwell & Baber, Attorneys for Mill Stream Corporation, dba Sullivan Harbor Farm and Ira J. (Joel) Frantzman
For Plaintiff: THOMAS E. DELAHANTY II United States Attorney District of Maine Andrew Lizotte Assistant United States Attorney U.S. Attorney’s Office, District of Maine, THOMAS E. ROSS Trial Attorney United States Dept. of Justice Consumer Protection Branch
Of Counsel: WILLIAM B. SCHULTZ General Counsel U.S. Dept. of Health & Human Services ELIZABETH H. DICKINSON Chief Counsel Food and Drug Administration PERHAM GORJI Deputy Chief Counsel, Litigation YEN HOANG Associate Chief Counsel for Enforcement U.S. Dept. of Health & Human Services
CONSENT DECREE OF PERMANENT INJUNCTION
JON D. LEVY U.S. DISTRICT JUDGE
Plaintiff, the United States of America (the “United States”), by its undersigned attorneys, having filed a complaint for injunctive relief (the “Complaint”) against Mill Stream Corporation, a Maine corporation doing business as Sullivan Harbor Farm (“Corporate Defendant”), and individual Ira J. Frantzman (together, “Defendants”), and Defendants having appeared and having consented to entry of this Consent Decree of Permanent Injunction (“Decree”) without contest, solely for the purpose of settling this case and without admitting or denying the allegations, and before any testimony has been taken, and the United States having consented to this Decree;
IT IS HEREBY ORDERED, ADJUDGED, AND DECREED that:
1. This Court has jurisdiction over the subject matter and over all parties to this action.
2. The Complaint states a cause of action against Defendants under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq. (the “Act”).
3. The Complaint alleges that Defendants receive raw fish and prepare, process, pack, hold, and distribute refrigerated, vacuum packed, ready-to-eat cold and hot smoked fish or fishery products in interstate commerce, at and/or from their manufacturing facility, located at 1545 U.S. Highway 1, Hancock, Maine (the “1545 Facility”). The Complaint alleges that Defendants violate the Act, 21 U.S.C. § 331(a), by causing to be introduced or delivered for introduction into interstate commerce articles of food, within the meaning of 21 U.S.C. § 321(f), namely fish or fishery products, that are adulterated within the meaning of 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health.
4. The Complaint alleges that Defendants violate the Act, 21 U.S.C. § 331(k), by causing articles of food within the meaning of 21 U.S.C. § 321(f), namely fish or fishery products, to become adulterated within the meaning of 21 U.S.C. § 342(a)(4) while held for sale after shipment of one or more components in interstate commerce.
5. Defendants represent to Plaintiff and the Court that Defendant Frantzman is a co-owner of the Ironbound Restaurant and Inn, located at 1513 Highway 1, Hancock, Maine (the “Restaurant”), and that the Restaurant has sold and served to its retail customers smoked or cured fish or fishery products manufactured by the Defendants for their customers’ end-point consumption. Defendants further represent that the Corporate Defendant owns and operates a retail store on or adjacent to the premises of the 1545 Facility (the “Retail Store”). The Retail Store has held, sold, and/or distributed fish or fishery products manufactured by Defendants as well as other merchandise and food products manufactured by wholly unrelated third-party suppliers.
6. Defendants and each and all of their officers, agents, employees, representatives, successors, assigns, attorneys, and any and all persons in active concert or participation with any of them (including individuals, directors, corporations, subsidiaries, affiliates, and partnerships) who have received actual notice of this Decree by personal service or otherwise are hereby permanently restrained and enjoined, under the provisions of 21 U.S.C. § 332(a) and the equitable authority of this Court, from directly or indirectly receiving, preparing, processing, packing, labeling, holding, and distributing articles of food, including but not limited to cold and hot smoked fish or fishery products, at or from the 1545 Facility and/or any other location(s) at or from which any Defendant, now or in the future, receive, prepare, process, pack, label, hold, or distribute articles of food (“Defendants’ Facility”), 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, and that is qualified to collect and analyze product samples collected at Defendants’ Facility for water phase salt levels and environmental and product samples for the presence of Listeria monocytogenes (“L. mono”) at Defendants’ Facility in a manner that is acceptable to the United States Food and Drug Administration (“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;
(B) Defendants retain, at their expense, an independent expert or experts (the “Expert(s)”) 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:
(1) develop adequate Hazard Analysis and Critical Control Point (“HACCP”) plans for Defendants’ fish or fishery products, as required by 21 C.F.R. §§ 123.6(a)-(c);
(2) verify and ensure the adequacy of Defendants’ HACCP plans, including, but not limited to, conducting scientific validation studies of the adequacy of the critical limits listed in Defendants’ HACCP plans for fish or fishery products including, but are not limited to, smoked salmon, trout, and char;
(3) develop procedures for processing Defendants’ fish or fishery products to achieve water phase salt levels that adequately control Clostridium botulinum (“C. bot”) hazards;
(4) develop adequate written Sanitation Standard Operating Procedures (“SSOPs”) in accordance with paragraph 6(C)(3), below;
(5) develop a Listeria Monitoring Program in accordance with paragraph 6(C)(4), below;
(6) evaluate Defendants’ compliance with current good manufacturing practice (“cGMP”) requirements for food, as set forth under 21 C.F.R. Part 110;
(7) develop and conduct employee training programs on the seafood HACCP and cGMP regulations, and SSOPs, HACCP plans, and Listeria Monitoring Program approved by FDA pursuant to paragraph 6(E) below; and
(8) inspect Defendants’ Facility and determine whether their methods, facilities, and controls are operated and administered in conformity with the Act, its implementing regulations, and this Decree.
Defendants shall notify FDA in writing of the name(s) and qualifications of the Expert(s) under paragraph 6(B) as soon as they retain such Expert(s).
(C) after review of all FDA inspectional observations of deficiencies from February 2004 to the present, Defendants’ Expert(s), in conjunction with Defendants, has:
(1) developed, to FDA’s satisfaction, adequate written HACCP plan(s), as required by 21 C.F.R. Part 123, for each type of fish and/or fishery products received, prepared, processed, packed, labeled, held, or distributed by Defendants. Such HACCP plan(s) shall effectively control food-safety hazards reasonably likely to occur for each type of fish or fishery product that Defendants intend to process, in accordance with 21 C.F.R. Part 123, including, but not limited to, C. bot. growth and toxin formation in smoked fish or fishery products; and
(2) developed and conducted, to FDA’s satisfaction, scientific validation studies of the adequacy of the critical limits listed in Defendants’ HACCP plans for their fish and/or fishery products, and made changes to the HACCP plan(s), as necessary, based on the results of the studies. Such studies shall, at a minimum, confirm that the critical limits established for refrigerated vacuum-packaged, hot and cold smoked fish or fishery products are sufficient to consistently achieve a water phase salt level of 3.5% or higher;
(3) developed, to FDA’s satisfaction, written SSOPs specific to Defendants’ Facility and operations and that shall conform with the procedures set forth at 21 C.F.R. §§ 123.11(a)-(d), and shall ensure that ...