The opinion of the court was delivered by: MUNSON
This is an action commenced by the United States, through the Food and Drug Administration (F.D.A.), for violation of section 301 of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 331
; jurisdiction being alleged under section 302 of that Act, 21 U.S.C. § 332.
The Government is primarily seeking to enjoin the shipment of frozen, french-style green beans
processed and packaged by defendant General Foods Corporation at its Fulton, New York facility, between August 23, 1977 and September 10, 1977, inclusively.
Also named as defendants are Ross Barzelay, President of General Foods, Edward R. Fencl, General Foods Business Manager for Fruits and Vegetables in the Food Products Division, David E. James, Director of Quality Assurance, Environmental Control and Occupations Safety for General Foods, and James W. Beno, Facility Manager for General Foods' Fulton, New York processing plant.
The Government claims that the defendants have violated the Food, Drug, and Cosmetic Act in two separate and distinct fashions. The Complaint alleges that the beans in issue are adulterated under section 402(a)(3) of the Act, 21 U.S.C. § 342(a)(3) [hereinafter referred to as (a)(3)], whereby a food is adulterated "if it consists in whole or in part of any filthy, putrid, or decomposed substance...." The Government also contends that the beans are adulterated within the meaning of section 402(a)(4), 21 U.S.C.§ 342(a)(4) [hereinafter simply (a)(4)], which provides that a food is adulterated "if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth...."
The (a)(3) charge of adulteration stems from analyses performed upon five samples of finished product, frozen french-style green beans, three of which were taken by F.D.A. inspectors during an inspection of the Fulton facility on August 23-25, 1977, the others having been confiscated during a September 9-10, 1977 inspection. Microscopic examinations of those samples revealed the presence in all five of Geotrichum mold, commonly known as machinery mold.
The (a)(4) violation relates to observations made by F.D.A. inspectors during the August and September inspections. In particular, the (a)(4) charge relates to a visible buildup of green, slime-like vegetable matter on belts and equipment contained within defendants' Fulton processing plant. Samples of that slime taken on two separate occasions revealed the presence of Geotrichum, or machinery mold. The (a)(4) portion of the Complaint also contains allegations of other insanitary plant conditions, including inspectors' observations of house and fruit flies within the Fulton facility.
PRE-TRIAL MOTION TO DISMISS
The defendants have moved for dismissal of the Complaint, both under Rule 12(b)(1) of the Federal Rules of Civil Procedure, Title 28 U.S.C., claiming that this Court lacks subject matter jurisdiction and Rule 12(b)(6), claiming that the Complaint fails to state a claim upon which relief can be granted. The gravamen of the defendants' arguments in support of dismissal concerns the failure of the F.D.A. to establish defect action levels (DAL), or tolerances, with regard to Geotrichum mold, to serve as guidelines to the food processing industry. The defendants claim that, because the presence of Geotrichum in processed frozen green beans is inevitable and unavoidable to a certain degree, the F.D.A. must establish a DAL below which the presence of Geotrichum in frozen green beans will be tolerated by the F.D.A. under section 306 of the Act, 21 U.S.C. § 336. The failure of the F.D.A. to establish such a tolerance, the defendants claim, should result in the Government's not being able to establish good cause for granting the injunction, thereby depriving this Court of subject matter jurisdiction.21 U.S.C. § 332(a). The defendants also contend that such failure to establish DALs for Geotrichum renders F.D.A. actions, such as this, for (a)(3) and (a)(4) violations, based upon the presence of Geotrichum, arbitrary and capricious, thereby requiring that this Court deny injunctive relief based upon the equitable "clean hands doctrine."
As previously stated, the green beans in issue are adulterated, under (a)(3), if they consist in whole or part of any filthy substance. The courts which have had occasion to interpret the word "filthy", as used in that section, have been unanimous in applying a common, everyday definition, rather than attempting to define it in a scientific or technical sense. See, e.g. United States v. Cassaro, Inc., 443 F.2d 153 (1st Cir. 1971); United States v. 44 Cases, Etc., 101 F. Supp. 658 (E.D.Ill.1951); United States v. Swift & Co., 53 F. Supp. 1018 (M.D.Ga.1943). Under such a definition, there can be no question, and the defendants do not assert otherwise, that Geotrichum mold fragments constitute filth. See United States v. Swift & Co., supra.
Under the terms of the statute, an (a)(3) adulteration violation is proven once the presence in the food of any quantity of filth is established. United States v. 900 Cases, Etc., Peaches, 390 F. Supp. 1006 (E.D.N.Y.1975); cf. Dean Rubber Manufacturing Company v. United States, 356 F.2d 161 (8th Cir. 1966); also cf. A. O. Andersen & Co. v. United States, 284 F. 542 (9th Cir. 1922).Moreover, to prove adulteration under (a)(3), it is not necessary for the Government to demonstrate that the food is injurious or unfit for consumption, United States v. Cassaro, Inc., supra; United States v. 484 Bags, More or Less, 423 F.2d 839 (5th Cir. 1970); United States v. 449 Cases, Containing Tomato Paste, 212 F.2d 567 (2d Cir. 1954).
The problem which arises with regard to adulteration under (a)(3), as well as other portions of the Food, Drug, and Cosmetic Act, is brought into sharp focus by the facts of this case, together with the defendants' legal arguments in support of their motion to dismiss. There can be no question that an expert, armed with the proper equipment, could detect filth in virtually every food marketed. United States v. 484 Bags, More or Less, supra; United States v. 1,200 Cans, Pasteurized Whole Eggs, Etc., 339 F. Supp. 131 (N.D.Ga.1972); United States v. Capital City Foods, Inc., 345 F. Supp. 277 (D.N.D.1972). The F.D.A., in fact, seemingly recognizes this as being true, as is evidenced by an article, cited by the defendants, which appeared in the Federal Register on September 30, 1977. 42 Fed.Reg. 52,814 (1977). Consequently, strict enforcement, by the F.D.A., of section 402 of the Act would result in the banning of literally all processed foods. United States v. 484 Bags, More or Less supra.
In order to ameliorate the hardships which would result from such a literal interpretation, Congress empowered the F.D.A. to use its discretion and decline prosecution for minor violations. 21 U.S.C. § 336; United States v. 484 Bags, More or Less, supra; United States v. 449 Cases, Containing Tomato Paste, supra. The defendants contend that the failure of the F.D.A. to set defect action levels, in order to alert the industry as to under what conditions an (a)(3) violation would be prosecuted, based upon the presence of Geotrichum mold, is unfair, and should result in a dismissal of the present case. In support of this argument, the defendants rely heavily upon language contained in Judge Frank's dissent in United States v. 449 Cases, Containing Tomato Paste, supra, and upon the Seventh Circuit Court of Appeals' opinion in United States v. 1,500 Cases More or Less, Etc., 236 F.2d 208 (7th Cir. 1956).
Despite the defendants' assertions to the contrary, the F.D.A. is not statutorily required to establish tolerances, or DALs, with respect to (a)(3) violations. United States v. Certified Grocers Co-Op., 546 F.2d 1308, 1311 fn. 5 (7th Cir. 1976); United States v. Hunter Pharmacy, Inc., 213 F. Supp. 323 (S.D.N.Y.1963); United States v. 233 Tins, More or Less, Etc., 175 F. Supp. 694 (W.D.Ark.1959). While Congress has apparently mandated that the F.D.A. establish tolerances for poisonous or deleterious substances which are required or unavoidable in the production of food, such regulations relating to adulteration under § 402(a)(2) of the Act, 21 U.S.C. § 342(a)(2), see 21 U.S.C. § 346, there is no like requirement relative to (a)(3) violations.
That is not to say that the F.D.A. does not have the authority to enact such DALs with respect to (a)(3) violations, whether under 21 U.S.C. § 336, United States v. 484 Bags, More or Less, supra; cf. United States v. Goodman, 486 F.2d 847 (7th Cir. 1973), 21 U.S.C. § 341, United States v. 1,200 Cans, Pasteurized Whole Eggs, Etc., supra, or pursuant to 21 U.S.C. § 371(a). United States v. Nova Scotia Food Products Corp., 568 F.2d 240 (2d Cir. 1977). But see United States v. 449 Cases, Containing Tomato Paste, supra.
The mere enactment of regulations establishing tolerances for filth in foods, below which levels the F.D.A. will not prosecute, does not always alleviate the court's task of deciding whether an (a)(3) violation has occurred. The courts are not bound by such DALs, and may well choose to apply a stricter standard than that set by the F.D.A. in any particular instance. United States v. 484 Bags, More or Less, supra at 842; United States v. 449 Cases, Containing Tomato Paste, supra at 575; see also Dean Rubber Manufacturing Company v. United States, supra [dictum]. In fact, a court is not empowered (in theory) to overlook any (a)(3) violation, regardless of what tolerance, if any, has been set by the F.D.A. United States v. 449 Cases, Containing Tomato Paste, supra.
The harshness of this result is somewhat lessened by the application of a de minimis doctrine, whereby small quantities of filth can be overlooked by a court, especially in circumstances where no applicable DAL is in effect and there is no evidence that that quantity found is avoidable through the use of good manufacturing practice, taking into account the state of the industry. United States v. 1,500 Cases More or Less, Etc., supra at 215; United States v. 449 Cases, Containing Tomato Paste, supra; United States v. 900 Cases, Etc., Peaches, supra; United States v. Capital City Foods, Inc., supra at 278-279; United States v. 233 Tins, More or Less, Etc., supra at 702; see also United States v. 133 Cases of Tomato Paste, 22 F. Supp. 515 (E.D.Pa.1938), decided under the Section 7 of the old Food and Drug Act, formerly 21 U.S.C. § 8. In applying a de minimis standard, a court must, of necessity, rely heavily upon the testimony of expert witnesses well acquainted with both the food and foreign substance at issue, as well as the state of the industry. See, e.g., United States v. 1,500 Cases, More or Less, Etc., supra at 212. For this reason, it would seem that a motion for dismissal of an (a)(3) violation which is arguably de minimis should be denied, so that the Court can have the benefit of such witnesses' expertise in applying the de minimis doctrine.
As previously noted, the defendants argue that it is unfair to allow the F.D.A. to indiscriminately exercise its discretion under 21 U.S.C. § 336 in determining when or when not to prosecute for (a)(3) violations, in particular relating to Geotrichum mold, which they assert is an unavoidable component of processed green beans. This argument, one proferred in the context of the equitable clean hands doctrine, could easily be considered as a Constitutional vagueness argument, grounded in the Due Process clause of the Fourteenth Amendment. Cf. Boyce Motor Lines v. United States, 342 U.S. 337, 72 S. Ct. 329, 96 L. Ed. 367 (1952). The vagueness argument fails, however, by virtue of the fact that (a)(3) very clearly prohibits all filthy, putrid or decomposed substances contained in food, and is therefore far from vague; Dean Rubber Manufacturing Company v. United States, supra; see also United States v. Thriftimart, Inc., 429 F.2d 1006 (9th Cir. 1970), cert. den. 400 U.S. 926, 91 S. Ct. 188, 27 L. Ed. 2d 185 (1970), reh. den. 400 U.S. 1002, 91 S. Ct. 453, 27 L. Ed. 2d 454 (1971). The equitable argument based upon the unfairness of the F.D.A. charging (a)(3) violations, where no DALs exist to place the industry on notice as to what levels are acceptable, is somewhat more appealing, and has in fact been accepted, to varying degrees, by some. United States v. 449 Cases, Containing Tomato Paste, supra at 575 (Frank, J., dissenting); United States v. 1,500 Cases, More or Less, Etc., supra at 211. The Second Circuit Court of Appeals majority implicitly rejected this equitable argument in United States v. 449 Cases, Containing Tomato Paste, supra, a case in which Judge Frank issued a dissenting opinion explicitly accepting the position now espoused by the defendants. See United States v. 900 Cases, Etc., Peaches, supra at 1011. When weighed against the public health and welfare sought to be protected by Congress through enactment of the Food, Drug, and Cosmetic Act, United States v. Diapulse Corporation of America, 457 F.2d 25 (2d Cir. 1972), the unfairness to the industry is minimized and should not bar enforcement of the Act.
This Court therefore denies the defendants' motion to dismiss, finding that this Court does possess subject matter jurisdiction, by virtue of 21 U.S.C.§ 332(a), and rejecting defendants' equitable clean hands argument. The Court will defer any consideration of the de minimus doctrine, as applied in this case, until the evidence presented in the trial is weighed.
A hearing was commenced before this Court on December 19, 1977, upon the Government's request for preliminary and permanent injunctive relief. See Fed.R.Civ.P. Rule 65(a)(2). What follows herein may be considered the ...