Heterochemical Corp. v. Food and Drug Admin., CV-86-0864.
| Citation | 741 F. Supp. 382 |
| Decision Date | 15 July 1990 |
| Docket Number | No. CV-86-0864.,CV-86-0864. |
| Parties | HETEROCHEMICAL CORPORATION, et al., Plaintiffs, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants. |
| Court | U.S. District Court — Eastern District of New York |
Joel E. Hoffman, William K. Tom, Sutherland, Asbill & Brennan, Washington, D.C., Stephen M. Hudspeth, Lord Day & Lord, New York City, for plaintiffs.
David Nocenti, Asst. U.S. Atty., Brooklyn, N.Y., for defendants.
Plaintiffs in this action moved for summary judgment, and defendants have cross-moved. Since there are no material factual issues in dispute, this court must now render judgment as a matter of law.
Heterochemical manufactures swine and poultry feed ingredients called Vitamin K Active Substances ("VKAS"). They market two kinds of VKAS, menadione dimethyl primidinol bisulfite ("MPB"), and menadione sodium bisulfite complex ("MSBC"). MPB may be used in swine, chicken, and turkey feed at levels specified by a food additive regulation, 21 C.F.R. § 573.620. MSBC is "prior sanctioned"1 for use in poultry feed at levels of 2 to 4 grams per ton.
In 1974, Heterochemical petitioned the FDA to determine the legal status under the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301, et seq., of certain VKAS products its competitors were marketing either in forms chemically distinct from that made by Heterochemical, or for use other than in poultry feed (and thus not prior sanctioned). Under the FDCA, if a food is not prior sanctioned it is considered a "food additive," unless it is shown to be generally recognized as safe ("GRAS"). 21 U.S.C. § 321(s). Food additives are in turn deemed "unsafe," and therefore barred from sale in interstate commerce, unless they are used in conformance with an FDA regulation. Id., §§ 331(a), 342, 348(a). The procedure for determining the food additive status of a food is contained in 21 C.F.R. Part 570.
On August 11, 1976, the FDA published a notice in the Federal Register (the "'76 Notice"). This notice stated that, in response to a petition from Heterochemical, the Commissioner was "considering whether to propose under the provisions of current 21 C.F.R. § 570.38 to determine that various VKAS are not GRAS and are food additives subject to ... 21 U.S.C. 348." The notice further stated that the Commissioner would receive, for 60 days, comments concerning VKAS. After discussing the history of VKAS, the notice concluded as follows:
41 Fed.Reg. 35009 (August 18, 1976).
Over the course of the next seven years, the FDA considered Heterochemical's petition and the 47 public submissions received in response to the '76 Notice. The administrative record compiled as a result comprised six volumes, and details information, in the form of scientific studies and other documents, received from manufacturers, nutritionists, and the U.S. Department of the Interior.
On April 19, 1983, the FDA published another notice (the "'83 Notice") which reported the results of its study. The notice reported, inter alia, that the evidence studied was not sufficient to allow the FDA to classify VKAS as GRAS. The notice also stated, however, that "VKAS have been added to animal food for more than 30 years, without apparent animal or human safety problems," and that therefore "the Agency does not plan to propose the issuance of food additive or GRAS affirmation regulations for VKAS at the present time" and "denies Heterochemical's petition." 48 Fed.Reg. 16748 (April 19, 1983).
Heterochemical brought suit to compel the FDA to take further steps, as the FDA is authorized to do under 21 C.F.R. § 570.38. FDA's motion to dismiss this action on the grounds that its decision not to act was unreviewable was denied, 644 F.Supp. 271 (E.D.N.Y.1986). The parties thereafter moved and cross-moved for summary judgment.
The FDA renews its argument that its decision not to take any action beyond the publication of the '83 Notice is completely unreviewable. In support of this proposition, it cites Heckler v. Chaney, 470 U.S. 821, 105 S.Ct. 1649, 84 L.Ed.2d 714 (1985), and Community Nutrition Institute v. Young, 818 F.2d 943 (D.C.Cir.1987). Both of these cases clearly hold that a decision by the FDA not to initiate "enforcement proceedings" as provided by the FDCA is completely within its discretion, and is not subject to judicial review. Both of these decisions, however, rely on the fact that the "enforcement proceedings" sought by the plaintiffs were those that the FDCA merely authorizes or allows2, but does not require. See, Chaney, 470 U.S. at 835, 105 S.Ct. at 1657, Community Nutrition, 818 F.2d at 949-50. These cases, therefore, stand only for the proposition that a decision by the FDA not to initiate a discretionary enforcement proceeding is unreviewable. They do not hold that the FDA may refuse to take any mandatory enforcement steps prescribed by statute or regulation. As the Supreme Court said in Chaney, "agencies are not free to disregard legislative direction in the statutory scheme that the agency administers." 470 U.S. at 833, 105 S.Ct. at 1656. In fact, the FDA does not dispute that agencies are obliged to follow their own regulations. See, Vitarelli v. Seaton, 359 U.S. 535, 79 S.Ct. 968, 3 L.Ed.2d 1012 (1959); Service v. Dulles, 354 U.S. 363, 77 S.Ct. 1152, 1 L.Ed.2d 1403 (1957); Accardi v. Shaughnessy, 347 U.S. 260, 74 S.Ct. 499, 98 L.Ed. 681 (1954).
The only issue before the court, then, is whether the actions Heterochemical seeks to compel are mandated by statute or regulation. All Heterochemical currently seeks from the FDA is that it, by notice published in the Federal Register, either 1) promulgate a food additive regulation governing use of the VKAS studied, 2) promulgate an interim food additive regulation governing their use, 3) require discontinuation of their use, or 4) adopt any combination of these approaches for different uses or levels of use of the VKAS studied. Heterochemical claims that this action is mandated by 21 C.F.R. § 570.38. If this contention is correct, this court may order the FDA to comply with such mandate. See, American Public Health Assoc. v. Veneman, 349 F.Supp. 1311 (D.D.C.1972); Hoffmann-LaRoche, Inc. v. Weinberger, 425 F.Supp. 890 (D.D.C.1975). The discussion below is therefore concerned only with the question of whether 21 C.F.R. § 570.38 requires the FDA to take the steps requested by Heterochemical.
The word "may" in this regulation clearly indicates that the decision whether to issue such a notice is discretionary.
Subsection (2) of this regulation provides that, if such a notice is published, it will allow 60 days for public comment. Subsection (3) provides, in relevant part, as follows:
The Commissioner will evaluate all comments received. If he concludes that there is a lack of convincing evidence that the substance is GRAS or is otherwise exempt from the definition of a food additive in 21 U.S.C. § 321(s), he will publish a notice thereof in the Federal Register.
The word "will" in this subsection clearly indicates that if the Commissioner chooses to commence the procedure described in (b)(1), he must publish the notice described above upon a finding that sufficient evidence has not been produced to determine that the substance studied is GRAS or otherwise exempt from 21 U.S.C. § 321(s). 21 C.F.R. § 570.38(c) provides that:
A Federal Register notice determining that a substance is a food additive shall provide for the use of the additive in food or food-contact surfaces as follows: (1) It may promulgate a food additive regulation governing use of the additive. (2) It may promulgate an interim food additive regulation governing use of the additive. (3) It may require discontinuation of the use of the additive. (4) It may adopt any combination of the above three approaches for different uses or levels of use of the additive.
The word "shall" in this subsection clearly indicates that if the Commissioner publishes such a notice, it must provide for one of the four listed alternatives. The word "may" in (1)-(4) would thereby merely indicate that the Commissioner retained discretion as to which of the four approaches to pursue.
Read together, the above subsections provide the Commissioner with discretion to initiate the (b)(1) procedure, but require certain actions if such procedure is commenced. These actions are precisely those sought by Heterochemical. Therefore, the crucial question is whether the (b)(1) procedure was ever initiated. This, in turn, depends upon whether the '76 notice was a (b)(1) notice. Heterochemical asserts that it was, and the FDA argues that it was not. In the final analysis, this is the only dispute between the parties.3
The starting point for any consideration of this question must be the Notice itself. Unfortunately, the language of the Notice is contradictory. The first paragraph says that the Commissioner is merely "considering whether to propose to determine" (...
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