The opinion of the court was delivered by: DOOLING
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 (21 C.F.R. §§ 128(a).1 to 128(a).7) 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 degree F. for 30 minutes if the salinity of the fish was at 3.5% or at 150 degree 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 degree 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:
"(c) Presmoking Operation.
"(4) Hot-process smoked or hot-process smoke-flavored fish shall be brined in such a manner that the final salt (sodium chloride) content of the loin muscle of the finished product, expressed as percent in the water phase of the loin muscle, shall not be less than:
"(i) 3.5 percent if heat-processed as prescribed under paragraph (d)(2)(i) of this section; or
"(ii) 5.0 percent if heat-processed as prescribed under paragraph (d)(2)(ii) of this section.
"(d) Heating, cooking, smoking operation.
"(2) Hot-process smoked or hot-process smoke-flavored fish shall be heated by a controlled heat process that provides a monitoring system positioned in as many strategic locations in the oven as necessary to assure a continuous temperature throughout each fish of:
"(i) Not less than 180 degree F. for a minimum of 30 minutes for hot-process smoked or hot-process smoke-flavored fish which have been brined to contain 3.5 percent water phase salt in the finished product as prescribed in paragraph (c)(4)(i) of this section, . . ., or
"(ii) not less than 150 degree F. for a minimum of 30 minutes for hot-process smoked or hot-process smoke-flavored fish which have been brined to contain 5.0% water phase salt in the finished product as prescribed in paragraph (c)(4)(ii) of this section."
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 proessed. 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 degree F. and the finished product is required to be cooled to 50 degree F. within 3 hours of cooking and to 38 degree 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 degree 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 presmoking 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 attack centers on the unquestioned fact that only 21 U.S.C. § 342(a)(4) can be looked to as the source of the Food and Drug Commissioner's authority to adopt the regulations. Defendants claim that it does not authorize any such regulation. It provides in seeming simplicity that
"A food shall be deemed to be adulterated -
"(a) . . . (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health."
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 visualized is remote and unreal in the case of smoked white fish. Defendants argue that to the extent this problem has been associated with smoked white fish, it has been associated with vacuum packaged white fish. That is a mode of packing not followed by the defendants and which apparently is no longer employed in the industry at all.
The final phase of the attack rests on the argument that the regulation is unsupported by the record which it is entitled to call to its support. That record, it is argued, consists only of those materials submitted to the Commissioner by the industry and other interested parties in the course of the rule-making procedure and the materials brought forward and disclosed to the interested parties as being other materials consulted by the Commissioner in arriving at the regulations, to the extent that he did not rely solely on materials submitted in response to the notice of rule-making.
1. There is no doubt that the Current Good Manufacturing Practice (sanitation) regulations, as they are frankly styled in 21 C.F.R. § 128(a).2, are adopted under 21 U.S.C. § 342(a)(4), and that the Commissioner (as the delegate of the Secretary of Health, Education and Welfare, 21 C.F.R. § 2.120(a)(1), (15)) derived his rule-making authority in this relation solely from 21 U.S.C. § 371(a) which provides simply that
"The authority to promulgate regulations for the efficient enforcement of this chapter, except as otherwise provided in this section, is vested in the Secretary."
Since the evidence is clear that the occurrence of C. botulinum Type E in white fish is not in fact or in the perspective of the statute a consequence of contaminations caused by unclean manufacturing practices or conditions, defendants' central argument is that the part of the Current Good Manufacturing Practice (sanitation) regulations here involved is, since oriented wholly to the sterilization of C. botulinum Type E occurring naturally in the fish and ingested in their native, water habitat, wholly unauthorized by the statute, and a nullity.
As defendants point out, Section 342(a)(4) has not the specificity found in Section 344(a) dealing with the issuance, in emergencies, of temporary permits. These permits impose conditions governing the manufacturing process. They are issued when, in any locality, contamination with microorganisms is found to be occurring in the processing of any class of foods. And it could be said too that subdivision (4) does not use any of the general language used in other subdivisions of Section 342(a) which deal with substances in, the condition of, the source of, or the packaging of food: it does not use words like "poisonous," or "deleterious," or "putrid," or "decomposed," or "diseased," or "unfit for food." However it evinces a manifest and dominant purpose to deal with the cases in which the food has been prepared, packed or held under conditions whereby it may have become contaminated with filth or may have been rendered injurious to health. Describing the manufacturing condition as "insanitary" is secondary: the word is given operative content only by reference to the purpose of subsection (a)(4), that is, to provide against whatever condition of processing may render the product injurious to health or contaminate it with filth.
Only subdivision (4) of Section 342(a) treats a food as adulterated whether or not the food has in fact been contaminated or rendered injurious to health. Food is considered adulterated if it has been prepared, packed or held under conditions that may have resulted in its contamination or in its becoming injurious to health. It is the only one of the subdivisions which directly deals with processing rather than with product in defining the circumstances in which the food product will be considered adulterated. For purposes of subdivision (4), it is irrelevant that, by any other tests, the food could not have been determined to have been adulterated and could not have been condemned. While Section 342(a)(4) may literally seem to deal only with conditions brought about by processing itself, the regulation under review, Part 128a, is specifically addressed to setting processing parameters to prevent the "outgrowth and toxin formation of C. botulinum Type E." Seen in the perspective of Part 128a's purpose and the purpose of subsection (a)(4), the use of the word "insanitary" in subdivision (4) of Section 342(a) is, at worst, inelegant, but it is not inadequate to include preparing, packing or holding conditions which permit a continuance of the outgrowth and toxin formation of the C. botulinum Type E in the product under process. Because such procedures may render the smoked fish injurious to health, the regulations proscribe cooking the fish at too low a temperature and/or for an insufficient length of time with inadequate salination. The approach of the regulations is that the temperature-time-salinity linkage is indispensable to preventing the outgrowth and toxin formation of the C. botulinum Type E. It is beside the point that the bacterial infestation here is not one that invades the fish during the processing. A similar point under the earlier Act was met years ago in United States v. Forty Barrels, 1916, 241 U.S. 265, 279-281, 36 S. Ct. 573, 60 L. Ed. 995. It was suggested that if, as in the case of Coca Cola syrup, an offending substance was a ...