United States v. Nova Scotia Food Products Corp., 76 C 647.
| Decision Date | 17 August 1976 |
| Docket Number | No. 76 C 647.,76 C 647. |
| Parties | UNITED STATES of America, v. NOVA SCOTIA FOOD PRODUCTS CORP., et al., Defendants, and National Fisheries Institute, Intervenor. |
| Court | U.S. District Court — Eastern District of New York |
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David W. McMorrow, New York City (David G. Trager, U. S. Atty., Brooklyn, N.Y., Richard A. Merrill, Chief Counsel, Forrest T. Patterson, Rockville, Md., Assoc. Chief Counsel, and Arnold I. Friede, Asst. Chief Counsel, U. S. Food and Drug Administration, Washington, D.C., of counsel) for the Government.
Joseph H. Einstein, New York City and Richard S. Morey, Washington, D.C. (Aranow, Brodsky, Bohlinger, Benetar & Einhorn, New York City and Kleinfeld, Kaplan & Becker, Washington D.C., of counsel) for defendants and for intervenor.
MEMORANDUM INCORPORATING FINDINGS of FACT and ORDER
The action was commenced on April 7, 1976, in substance to compel the defendants to comply with the Current Good Manufacturing Practice (sanitation) regulations ) by preliminarily and permanently enjoining defendants from processing hot smoked fish unless and until their manufacturing practices are brought into conformity with the Current Good Manufacturing Practice (Sanitation) regulations
Defendants are engaged in Brooklyn in the business of receiving in interstate commerce frozen or iced white fish which are processed by defendants, that is, they are brined, smoked and cooked. The white fish are then held for distribution and distributed to stores as smoked white fish. The Food and Drug Administration inspectors made inspections of defendants' plant in July 1975 and again in February 1976, and on each occasion they found that defendants were not processing the smoked white fish in accordance with the regulations, primarily in that the process did not meet the heat and brining requirements of 21 C.F.R. § 128a.7(c)(4), (d)(2). Specifically the regulations required oven "cooking" the white fish at 180°F. for 30 minutes if the salinity of the fish was at 3.5% or at 150°F. for 30 minutes if the salinity was at 5%. There is no real dispute as to the facts of defendant's practice. The defendant did not heat the fish at 180°F. for a half hour nor did the salinity of the fish reach the 3.5% level.
The applicable portion of the regulation not complied with reads as follows:
The Current Good Manufacturing Practice (sanitation) regulations, dated November 2, 1970 and filed on November 12, 1970 for publication in the Federal Register of November 13, 1970 are not limited to salinity and temperature requirements. They include regulations with respect to unloading platform material and drainage; the provision of separate rooms for receiving and shipping, storing fish, pre-smoking operations including thawing, dressing and brining, and drying and smoking; the processes of packing and storage of the final product were to be carried out in separate rooms or facilities. There is a general requirement that the product be so processed as to prevent contamination by exposure to areas involved in earlier processing steps, to refuse, or to other objectionable areas. The regulations include equipment and utensil requirements with reference particularly to their being made of readily cleanable materials if they come into contact with the food products. The regulations require that adequate hand washing and sanitizing facilities be located in the processing room or rooms or in an area easily accessible from them; signs are to be provided directing employees to wash and sanitize their hands after each absence from their duty posts. There is provision for periodical removal of offal, and requiring that offal, debris, or refuse must not be accumulated in or about the plant. Each day the utensils and product-contact surfaces of equipment must be rinsed and sanitized, and fish containers are not to be nested or handled during processing in a manner conducive to contamination. The cleaning and sanitizing of utensils and equipment are to be so carried out so as not to lead to contamination of the product. Fish are to be adequately inspected and only clean, wholesome fish are to be processed. Time and temperature controls are established with respect to refrigerating, thawing, spraying and washing fish. Fish are to be completely eviscerated with the minimum disturbance of intestinal tract and thoroughly washed by a continuous spray system. The fish are to be brined in a solution that does not exceed 38°F. and the finished product is required to be cooled to 50°F. within 3 hours of cooking and to 38°F. or less within 12 hours after cooking. The finished product is to be handled only with clean, sanitized hands, gloves or utensils. Shipping containers are to indicate the perishable nature of the product and to specify that the fish must be shipped, stored and held for sale at 38°F. or less until consumed. The product is required to be coded so that each lot's processing history can be traced. Other sections of the regulations require indicating thermometers on freezer and cold storage elements and require a point-sensitive, continuous temperature-recording device to monitor both the internal temperature of the fish and the ambient temperature inside the processing oven, each recording device record to be identified as to specific oven load and date processed.
The regulations thus closely supervise the handling of the fish not only by covering the processing procedures but also by setting requirements for equipment, general procedures and plant cleanliness.
The inspections of July 1975 and February 1976 not only demonstrated failure to comply with the time and temperature and brining exactions of the regulations, but also revealed a failure to maintain the pre-smoking brining stage at the requisite low temperature and failure to achieve the requisite post-smoking and cooking temperature levels. The inspections at the defendant's plant disclosed further that it did not have all of the required indicating thermometers and temperature recording devices.
As already indicated, there is no claim of compliance with the regulations. The defendants have not in any substantial way contested the findings of the FDA inspectors and, indeed, have joined in a stipulation with respect to the findings on deviation from the salinity requirement of the regulations. On the contrary, defendants insist that the time-temperature-salinity standards of the regulations cannot be met without rendering the product unmarketable. The defense, then, has taken the form of an all-out attack on the validity of the regulations involved.
The contention takes a second form as an argument that in any event it would not suffice to show a violation of the regulation since the regulation is merely interpretive and not implementive of the law and, in consequence, the government must show that defendants violated the statute, reading the statute directly upon the facts; defendants say that no such showing of statutory violation has been made or attempted, for the Government has made no attempt to show any insanitary conditions at the plant if the word "insanitary" is read in its ordinary sense, the sense invited by its use in the same context with the words "contaminated" and "filth."
It is next argued that the nature and professed object of the regulations was to minimize the hazard to the public of Type E botulism and the risks of food borne infections in the consumption of smoked fish. It is argued that the regulations were put forward as the safest known processing parameters for preventing, through thermal destruction of spores of the bacteria, the outgrowth and toxin formation of Clostridium botulinum Type E. See Proposal of Part 128a for 21 C.F.R., 34 F.R. 17176 (October 16, 1969). It is argued that C. botulinum type Type E is not a contaminant that reaches the fish during processing but is undeniably taken up by the fish from the lake waters which are their natural habitat, and that the known material has long since made it perfectly clear that the risk...
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