in 1938 to replace the Food and Drugs Act of 1906, it, too, was placed under the Food and Drug Administration of USDA. In 1940, following a recommendation of the Brownlow Committee on Administrative Management, FDA was removed from USDA to the newly created Federal Security Agency and from there to the Department of Health, Education, and Welfare when HEW was created in 1953. However, USDA retained its longstanding responsibility for meat inspection and other aspects of meat regulation." Times, of course, have changed since 1906 and with the times the nature of food production has also changed. Increasingly the human diet has come to consist of highly processed foods, some containing meat and some with no meat ingredients. Existence of divided responsibility for regulating production of these foods has resulted in a regulatory program which is often duplicative, sometimes contradictory, undeniably costly and unduly complex. On one hand, a lack of flexibility in the mandates of the agencies results in a rigid division of authority which fails to mesh efficiently with the realities of a food production system that has turned increasingly to the processing of foods. Seemingly arbitrary divisions of authority between USDA and FDA inspectors occur under the roof of a single processing plant, and pursuit of violative products may be interrupted by a lack of access to a processing facility within the jurisdiction of the other agency. Furthermore, complete protection against a particular health hazard (e.g., botulism from low-acid canned food products) or a coordinated food labeling policy requires action by both agencies-agencies with different priorities, philosophies, and statutory direction." 5 Further, where regulatory authority has been imprecisely-or concurrently-allocated, the result has been confusion and uncertainty as to the limits of each agency's jurisdiction and an unrealistic demand for close cooperation between agencies which proceed under substantially different statutory direction and philosophies of regulation. Sometimes uncertainty has led to an excess of deference and the failure of either agency to act effectively in the face of a regulatory need." Lines of division 8 Although popular mythology holds that jurisdictional lines between USDA and FDA are clearly drawn, the legal reality is not so neat. In general, USDA's regulatory authority is limited to red meat and poultry and products containing red meat and poultry while FDA generally regulates non-meat food products. However, the Federal Meat Inspection Act (Meat Act), the Poultry and Poultry Products Inspection Act 10 (Poultry Act), and the Federal Food, Drug and * See p. 140. See pp. 118-125. See pp. 123-124, 130-134. 7 See pp. 122–123. Red meat" refers to beef, pork, lamb and other non-poultry sources of meat. The term "meat" as used herein refers to both red meat and poultry. The Department also Pas responsibility for enforcement of the Egg Products Inspection Act (EPIA) (21 U.S.C. $ 1031 et seq.). Much of the discussion about meat and poultry inspection applies equally for egg products inspection. For the sake of simplicity, however, most references to the EPIA have been eliminated. 221 U.S.C. §§ 601 et seq. 10 21 U.S.C. §§ 45 et seq. Cosmetic Act 11 form a patchwork of intricate inclusions, exclusions and interrelationships which frequently make a precise determination of where authority lies a most complicated matter. The law permits USDA to expand or contract its jurisdiction, and by indirection that of FDA, by administrative action. The Meat Act and the Poultry Act explicitly authorize USDA to exempt from the definition of "meat food product" and "poultry product" foods which contain red meat or poultry "only in relatively small proportion" and those which "historically have not been considered by consumers as products of the meat (or poultry) industry." 12 Apparently under that authority USDA and FDA have agreed to the operating rule that any food containing at least 2 percent meat will be subject to USDA's jurisdiction and thereby to regulation under the Meat and Poultry Inspection Acts rather than the Food and Drug Act. For years the agencies proceeded under this informal rule. Although regulations implementing that rule were proposed in 1973, they have not yet been finalized.13 However, the statute does not exclude FDA totally from regulating meat products. Although FDA may not perform on-site inspections of slaughterhouses or meat processing plants, its regulatory reach extends to meat and meat-containing products in several respects. Some of FDA's authority to affect the regulation of meat is explicit in statute. -Under the Food Additives Amendment of 1958 and the Color Additive Amendments of 1960, FDA must determine in the first instance which colors and other additives may be used in food products, including those containing red meat or poultry. The Meat and Poultry Inspection Acts explicitly permit only FDAapproved food additives to be used in meat products, the use of nonapproved substances constituting adulteration in violation of these USDA-administered statutes.14 -FDA has concurrent authority with USDA over meat products which have left a USDA-inspected plant. FDA is explicitly authorized by the Meat and Poultry Inspection Acts to detain allegedly violative meat products once they have left the USDAinspected facility.15 -FDA also enjoys concurrent jurisdiction with USDA over the -When USDA sets standards for any meat food product the law 11 21 U.S.C. § 321 et. seq. 1221 U.S.C. 601 (j), 21 U.S.C. § 453 (f). USDA has promulgated a regulation exempting certain poultry-related foods from the scope of regulation under the Poultry Act (9 C.F.R. 381.15). 13 38 Fed. Reg. 27298-9 (Oct. 2. 1973). 14 21 U.S.C. § 601 (m) (2) and 21 U.S.C. § 453 (g) (2). 16 This detention authority is identical to that which resides in USDA. FDA exercises it in enforcing the Food, Drug, and Cosmetic Act while USDA's authority is to be exercised to enforce the Meat and Poultry Inspection Acts, 21 U.S.C. § 679(b) and 21 U.S.C. $467 (f) (b). Ironically FDA lacks parallel authority to detain non-meat products while seeking judicial authority for seizure because no such authority is granted by the Food, Drug, and Cosmetic Act. This disparity would have been corrected by the proposed Food Safety Act, S. 641. 94th Cong., 1st Sess. (1975). 14 21 U.S.C. § 607 (c) and 21 U.S.C. § 457(b). standards established under the Federal Food, Drug and Cosmetic Act (by FDA)." 17 In addition to authority over aspects of meat regulation explicitly granted to FDA, there is also a complex "gray area" (in the words of both Agriculture Department and FDA counsel) in which a determination of FDA's authority to regulate red meat or poultry products depends upon an analysis of the extent of FDA's authority after passage of the Food, Drug, and Cosmetic Act in 1938 and whether a particular action by the Department of Agriculture would occur pursuant to authority granted to USDA before or after 1938. This situation grows out of the following provisions in these statutes. First, the 1967 amendments to the Federal Meat Inspection Act and the Poultry Products Inspection Act of 1957 state that these Acts "shall not derogate from any authority conferred by the Federal Food, Drug and Cosmetic Act" prior to the effective dates of these statutes.18 To determine precisely what authority over meat was conferred on FDA by the Food, Drug & Cosmetic Act ("FD & C Act") in 1938, it is necessary to compare that Act with the Meat Inspection Act of 1907. This comparison is necesary because the FD & C Act provides that "Meats and meat food products shall be exempt from the Food, Drug, and Cosmetic Act to the extent of the application or the extension thereto of the Meat Inspection Act (of 1907) ***" 19 Where USDA received a grant of authority under the 1907 Act (as, for example, with respect to inspection of slaughterhouses and meat processing facilities), USDA retains exclusive jurisdiction notwithstanding subsequent passage of the Food, Drug, and Cosmetic Act. However, to the extent FDA received additional authority-authority not provided for in the Meat Inspection Acts of 1907-FDA can proceed under that authority against all food products, including meat, notwithstanding later passage of the Wholesome Meat and Poultry Acts in 1967 and 1968. In short, whether USDA has exclusive jurisdiction to assert a particular power depends upon whether USDA is acting under authority granted in 1907 (which remains exclusive) or under authority granted after passage of the FD&C Act in 1938. Authority granted to USDA after 1938 is not exclusive if there is overlapping authority granted to FDA by the Food, Drug, and Cosmetic Act. Finally, it must be noted that authority over products containing meat sometimes shifts back and forth between agencies, depending upon the point in the stream of commerce in which the product is found. Thus, FDA asserts jurisdiction over live animals intended for the food supply while they are "on the hoof".20 Once they 19 21 U.S.C. 392 (b). 20 Although there is no explicit grant of authority to FDA concerning live animals, FDA has asserted its implied authority over food animals (including live cattle and poultry) and the courts have concurred. FDA has authority under 21 U.S.C. § 332(a) to seek to enjoin the introduction or delivery for introduction into interstate commerce of adulterated food. A live animal intended for interstate commerce presumably would be considered a "food" or a "raw agricultural commodity", which is a subcategory of "food". 21 U.S.C. $201 (f) (1) and 21 U.S.C. 201(r). Another basis for jurisdiction would be FDA's authority to regulate chemicals used in or on food, including animal food. See, e.g., 21 U.S.C. § 360(b). Of an animal population exceeding 3.5 billion in the United States, about three-quarters receive drugs in feed. Subcommittee on Oversight and Investigations of the House Com reach the slaughterhouse, USDA has exclusive jurisdiction over these animals, conducting both pre-mortem and post-mortem inspections. USDA retains exclusive jurisdiction over the meat (and over all ingredients, meat or non-meat) in the processing facility. However, the meat or meat food product becomes subject to the concurrent jurisdiction of USDA and FDA upon leaving the processing plant. Responsibility shifts again in retail establishments where FDA and USDA apparently share concurrent jurisdiction over any adulterated or misbranded meat products but only FDA has authority to inspect the premises.21 The following constitutes a case study of the practical results of this complex and divided regulatory system, with particular attention focused on food inspection, standards setting, labeling, and regulation of chemical additives in the food supply. B. AUTHORITY DIVIDED: INSPECTION OF FOOD PLANTS The Federal Government operates several food inspection systems, each with its own mandate and bureaucracy.22 Some Federal food inspection services are provided only to those who request and pay for them.23 These voluntary, reimbursible services are available as an adjunct to grading services which facilitate wholesale trade in various food commodities. Other food inspection services are performed to insure compliance with Federal procurement contracts.24 mittee on Interstate and Foreign Commerce, Federal Regulations and Regulatory Reform, 94th Cong., 2d Sess. 284 (Sub-comm. Print 1976). Recently, the United States District Court for the Southern District of Ohio concurred in a consent decree enjoining a swine grower from introducing into interstate commerce live animals until the grower demonstrates that its facilities will prevent animals grown at the facilities from producing contaminated food. The food the animals were fed and the animals themselves had been contaminated with poisonous chemicals. The decree recited that FDA has jurisdiction over live animals pursuant to its authority to regulate food and raw agricultural commodities. United States v. H. W. Martin et al, (No. -) (District Ct., S.D. Ohio) (July 21, 1977). See also, United States v. Sprague et al, 208 Fed 419 (Dist. Ct., E.D. New York 1913) (upholding seizure of unopened live oysters under the Pure Food and Drugs Act). Note, though, that USDA's Animal and Plant Health Inspection Service is responsible for determining the existence and extent of outbreaks of communicable diseases and pests affecting livestock and poultry. See 21 U.S.C. § 111 et seq. which authorizes the Secretary of Agriculture to take such measures as he may deem proper to prevent outbreaks of communicable diseases. A 1972 Opinion of the Attorney General states that USDA lacks jurisdiction to Inspect grocery stores, restaurants and other retail facilities, although USDA may enforce prohibitions against the sale of adulterated or misbranded meat products on these premises. It is unclear how this arrangement can work as a practical matter if USDA lacks authority to enter retail establishments to perform inspections essential to determine whether violative products are on the premises. Opinion of the Attorney General of the United States, "Applicability of the Federal Meat Inspection Act to Retail Establishments," (August 17, 1972). This case study does not deal with the complex relationship of the Federal inspection systems with the extensive State and local inspection services with which they frequently intermesh and/or overlap. See e.g., GAO Report B-168966, "Need to Reassess Food Inspection Roles of Federal Organizations," (June 30, 1970). See pages 125-128 for a discussion of the inspection and grading services of the Departments of Agriculture and Commerce. OMB's Office of Federal Procurement Policy (created by Pub. L. 93-400) has directed USDA to establish an Interagency Food Quality Assurance Planning Committee, the mission of which to develop a plan which will provide for "a single system for Government-wide quality assurance for food procured by Federal agencies." Chaired by USDA, the committee includes members from the Departments of Commerce, Defense, HEW, and the Veterans Administration. The Committee, according to its November 2. 1976 charter, will address itself to the elimination of overlap and duplication in inspection and the irrationality in setting divergent standards for specifications for acceptable food. We hope this Interagency Committee will proceed expeditiously in their responsibilities, with a strong emphasis on action rather than simply more documentation of the fact that duplication exists. See GAO Report B-168966. "Need to Reassess Food Inspection Roles of Federal Organizations (June 30, 1970) for a detailed discussion of duplication and overlap in procurement inspections. The major inspection systems, however, are those designed to insure that food for human consumption is wholesome and labeled in full compliance with government regulations. These mandatory inspections are administered by USDA's Food Safety and Quality Service,25 which is responsible for inspecting meat and meat food products, and the Food and Drug Administration (FDA) which bears inspectional jurisdiction over all non-meat foods. USDA and FDA: The two different worlds of food inspection The mandates of the Agriculture Department and the FDA are essentially the same: to keep the marketplace free of adulterated 26 and misbranded 27 food products. Moreover, there does not appear to be any health reasons why meat products should be treated much differently from other foods with regard to inspection. Nonetheless, the differences between the food inspection services administered by these agencies are more striking than their similarities. Created by separate statutory authority, administered by structurally unrelated agencies, separately funded and subject to oversight by different congressional committees, these systems reflect sharply contrasting procedures, philosophies and resources. The Food Safety and Quality Service, on one hand, carriers on a massive program of "continuous inspection" at slaughterhouses and meat processing plants.28 Under a continuous inspection system, a facility may operate lawfully only when a USDA inspector is on duty. If no inspector is present, the operation must shut down. USDA inspectors are therefore assigned to slaughterhouses and meat processing plants on a full time basis, enforcing the statutory prohibition against selling misbranded or adulterated meat products primarily before these products reach the marketplace. They accomplish their The Food Safety and Quality Service (FSQS) was created by the Secretary of Agriculture on March 14, 1977. Between 1972 and 1977 meat inspections were conducted by the Animal and Plant Health Inspection Service (APHIS). 26 21 U.S.C. § 342, 21 U.S.C. § 601 (m), 21 U.S.C. § 453 (g). 27 21 U.S.C. § 343, 21 U.S.C. § 601 (n), 21 U.S.C. § 453 (h). 28 The Federal Meat Inspection Act explicitly requires that USDA inspectors examine all livestock before slaughter (ante-mortem) for signs of disease or abnormality and each individual carcass and its viscera following slaughter (post-mortem). 21 U.S.C. § 603 and § 604. The Poultry Products Inspection Act requires post-mortem inspection of all poultry carcasses and permits ante-mortem inspection when the Secretary "deems necessary." 21 U.S.C. § 455. USDA has considered some relaxation of its interpretation that the Meat and Poultry Acts require continuous inspection of processing plants. While the Meat Inspection Act places an unavoidable obligation on USDA to make an affirmative determination at the processing plant that food is wholesome and lawful, it does not explicitly require that each phase of the processing be conducted under the continually watchful eye of a government inspector. See 21 U.S.C. § 606, 21 U.S.C. § 455. In fact, the Poultry Products Inspection Act explicitly provides discretion in the Secretary to dispense with continuous inspection of the processing of poultry and poultry products, 21 U.S.C. § 455. USDA has proposed a regulation which would permit processors to submit descriptions of their quality control procedures to USDA. If USDA then designated the plant as an "accepted product control establishment," USDA would then institute certain "official inspectional controls" in lieu of continuous monitoring of processing. 38 Fed. Reg. 30886-7 (Nov. 8, 1973), to amend 9 C.F.R. 318. Continuous inspection has been interpreted to mean that about 3,500 smaller plants may be inspected on a "circuit rider" or "patrol" basis under which a single inspector makes the rounds of approximately four plants during the course of a day, inspecting and providing the requisite USDA stamp of approval to newly produced products. The Inspector does not remain in a single plant throughout the day to monitor each phase of production prior to granting the approval required for distribution of the product. A recent report to the Department of Agriculture by Booz, Allen. and Hamilton recommended a new inspection system that mandates industry quality control and places the burden of proof of compliance with Federal laws and regulations on the industry. Evidence of compliance would be monitored and verified by Meat and Poultry Inspection Program inspectors, but each phase of the processing need not be directly monitored by a USDA employee. Study of the Federal Meat and Poultry Inspection System, 3 vols., U.S. Department of Agriculture, June 1977. |