The opinion of the court was delivered by: BRYANT
This matter is now before the Court on plaintiffs' Motion For Preliminary Injunction, and defendant's opposition thereto. In this action plaintiffs, various consumer-oriented public interest groups, state officials, and a Member of Congress, challenge the action of the Secretary of Agriculture in promulgating, without notice, public participation, or thirty-day delayed effective date, a new regulation which for the first time gives the formal sanction of the Department to the use of Mechanically Deboned Meat (MDM) as a constituent element of certain food products under his regulatory supervision. The regulation, 9 C.F.R. § 319.3, was published at 41 Federal Register 17535 on April 27, 1976, to be effective immediately.
Mechanically deboned meat is produced by pulverizing bones from which most meat has been removed by traditional hand means, then centrifuging the resultant mash through a fine sieve. The technology for producing MDM from red meat without undue bone fragments or metal slivers has only recently been developed. The machinery currently in use allows bone particles in MDM of a diameter of approximately.018 inches. The Department has been involved in the observation and supervision of such developing technology for about fifteen years, and in late 1974 felt that MDM technology had advanced to the point where it could produce acceptable red meat MDM for American consumption. Consequently, in November of 1974 it issued a bulletin to its inspectors, state officials, and meat producers specifying that MDM could thereafter be produced and sold in the United States under certain conditions and with certain specifications. Those specifications were subsequently revised, and on April 27th of this year the Department issued the instant regulation further modifying those specifications and defining the permissible uses of MDM. The regulation is issued as one of the "definitions and standards of identity or composition" for meat products pursuant to 21 U.S.C. § 607(c), part of the Federal Meat Inspection Act. Plaintiffs challenge the regulation as defective under the Administrative Procedure Act and as in substantive conflict with the Federal Meat Inspection Act, as amended, 21 U.S.C. §§ 601 et seq. Plaintiffs' basic claim in this regard is that the regulation permits the sale of adulterated and misbranded meat, contrary to the provisions of the Act. The Court entered a temporary restraining order against the operation of the regulation on September 1, 1976. Oral argument on the motion for preliminary injunction was held on September 9, 1976.
The standards for the issuance of a preliminary injunction are generally those found in Virginia Petroleum Jobbers Assn. v. F.P.C., 104 U.S. App. D.C. 106, 259 F.2d 921 (1958). However when federal statutes have been violated, it has long been the rule that a court need not inquire into the traditional requirements for equitable relief. See, United States v. City and County of San Francisco, 310 U.S. 16, 84 L. Ed. 1050, 60 S. Ct. 749 (1940); Atchison, Topeka, and Santa Fe Railway Co. v. Callaway, 382 F. Supp. 610, 623 (D.D.C., 1974); Lathan v. Volpe, 455 F.2d 1111, 1116 (C.A. 9, 1971). In any event, the facts of this case do satisfy the traditional requisites for the issuance of a preliminary injunction.
A. The Administrative Procedure Act Claims
The Secretary relies principally upon the "interpretative rule" exception to the requirements of 5 U.S.C. §§ 553 (b), (c), and (d), and secondarily on the "good cause" exception to those requirements, to excuse his failure to comply with the ordinary procedures of the APA. He argues that this regulation is merely an interpretative rule which states his opinion as to what does and does not constitute adulteration and misbranding, and has no force of law. These arguments are without merit. The Department has been deeply involved in the regulation of MDM for many years, and both it and the meat packing industry consider this regulation as an explicit limitation on the composition and uses of the product. When a regulatory agency exercises its statutory authority to set standards and prescribe conduct, as is the case here, it must do so in accordance with the substantive rulemaking provisions of the APA. This regulation is a "definition and standard of identity or composition", 21 U.S.C. § 607(c), and is civilly and criminally enforceable; indeed, the Department explicitly states that one of its purposes in promulgating the regulation is to have an enforceable limit on MDM content. In these circumstances, no serious contention can be made that the rule is within the exception to the rulemaking requirements of the APA as merely "interpretative". For like reasons, the Secretary's reliance on Skidmore v. Swift & Co., 323 U.S. 134, 89 L. Ed. 124, 65 S. Ct. 161 (1944) is wholly misplaced; the relationship between the situation at issue there and the present case is at best remote.
The "good cause" exemption to the rulemaking requirements is also inapplicable to the circumstances of this case. The Secretary specifies as the good cause for ignoring those requirements the need to obtain information and data for use in connection with the proposed rulemaking proceedings, related to the production of MDM and other matters, initiated at the same time as the promulgation of this "interim" rule. However when a health-related standard such as this is involved, the good cause exemption may not be used to circumvent the legal requirements designed to protect the public by ensuring that interested persons will have the opportunity to bring to the agency's attention all relevant aspects of the proposed action and thereby enhance the quality of agency decisions. If the Department wanted information to use in its rulemaking process, it could have simply required the industry to supply that information as a condition precedent to the approval of MDM under the Federal Meat Inspection Act as safe. The law requires the Secretary to determine that meat is not adulterated or to condemn that meat; the fact that he may not have the data necessary to make a determination of safety means that he cannot rule that meat is not adulterated, not that he may suspend the rulemaking requirements of the APA and expose the public to uncertain hazards while he collects information necessary to make those decisions. Indeed, the Secretary states in the preamble to the interim rule that the technology has "not been used sufficiently in this country to decide upon limits for protein, fat, and bone quantity, and protein quality that are appropriate and acceptable in various formulated products." 41 Fed. Reg. 17535. Far from being good cause for circumventing the normal rulemaking requirements, this constitutes a compelling reason to utilize those procedures before subjecting the public to any possible hazard. Accordingly, the Court holds that the promulgation of this regulation was in violation of the Administrative Procedure Act, and that in this regard plaintiffs are likely to succeed on the merits of their contentions.
Plaintiffs contend that processed meat products containing MDM, which this regulation permits to be sold in the United States, should be considered adulterated within the meaning of the Federal Meat Inspection Act. Such products are "meat food products", 21 U.S.C. § 601(j). Under subsection (m) of that section, such a product is adulterated:
(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health;
(8) if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefor; or if any damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is;
The Secretary argues that MDM containing bone particles or products containing MDM cannot be adulterated because the bone is actually "meat" under the Department's 1938 definition of meat, ...