National Pork Producers Council v. Bergland

Decision Date23 September 1980
Docket NumberNo. 80-1229,80-1229
Citation631 F.2d 1353
PartiesNATIONAL PORK PRODUCERS COUNCIL, an Iowa Corporation; Charles Grassley; Tom Hagedorn; and Steven Symms; and National Independent Meat Packers Association, Appellees, v. Bob BERGLAND, Secretary of Agriculture; Carol Tucker Foreman, Assistant Secretary of Agriculture for Food and Consumer Services; and Donald Houston, Acting Administrator, Food Safety and Quality Service, United States Department of Agriculture, Appellants.
CourtU.S. Court of Appeals — Eighth Circuit

Alice Daniel, Asst. Atty. Gen., Eloise E. Davies, Susan M. Chalker, Attys., Civ. Div., Dept. of Justice, Washington, D. C., for Bob Bergland et al.

Edwin H. Pewett, James M. Kefauver, James B. Davis, Glassie, Pewett, Beebe & Shanks, Washington, D. C., for National Meat Ass'n.

James L. Fox, Donald P. Colleton, Abramson & Fox, Chicago, Ill., for National Pork Producers.

Before HEANEY and BRIGHT, Circuit Judges, and HUNGATE, District Judge. *

HEANEY, Circuit Judge.

This appeal presents the question of whether the United States Department of Agriculture (USDA) properly exercised its authority when it issued regulations permitting nitrate and nitrite-free meat products to be sold under product names traditionally reserved for foods containing these compounds. The district court held that it did not. We reverse.

I

The history of nitrate and nitrite use in curing meat and poultry products is a long one. As early as Homer's time (900 B.C.), curing meat with salt was an established practice. Although it surely was not known at the time, the desert salts used in the curing process contained nitrate impurities, which caused cured meat to develop a characteristic spicy flavor and pink color. In addition, the curing process helped preserve the meat from bacterial spoilage. The cure was particularly effective, it is now known, in inhibiting the growth of Clostridium botulinum, the bacteria that produce the deadly toxin responsible for the food poisoning known as botulism.

Although curing is a centuries-old practice, it was not until the first part of the twentieth century that scientists identified the active agent responsible for the cure. The color, flavor and preservative effects were caused by the meat's reaction with nitric oxide, which was formed from nitrite, which was, in turn, formed from the nitrate used in the curing process. Because these reactions are difficult to control when meat products are cured with nitrate, the USDA formally authorized the direct addition of nitrite in 1925. In some products, such as bacon, some form of nitrite is required by USDA regulations. See 9 C.F.R. § 318.7(b) (1980). Because nitrite was recognized as potentially toxic, however, a maximum residual amount of 200 parts per million was established. Nitrate was not directly regulated.

In the late 1960's, concern developed over nitrite use as studies suggested that nitrites combined with other compounds in the food or in the body to form nitrosamines, which were known to be potent carcinogens in animals. As one report presented to a Senate Committee indicates, the possibility that nitrites could cause cancer touched off a flurry of activity:

In October 1969, meat industry scientists met with the Assistant Secretary of Agriculture to discuss the possibility of a nitrosamine problem existing in U.S. cured meat products. In December of 1969, a group of USDA, FDA, and industry scientists met to discuss the problem, resulting in the scheduling of a cooperative research program to be funded by industry and actively participated in by industry, FDA, and the Department. The Food and Drug Administration (FDA) and the U.S. Department of Agriculture organized a scientific study group to review appropriate information and data. In 1971, the House Intergovernmental Relations Subcommittee conducted hearings on the issue of nitrosamine formation and the possible involvement of nitrite in cured foods. The matter was widely discussed by the public and the media, and further studies were carried out by the scientific community. Numerous conferences were held during 1972, to discuss available information on the role of nitrite in curing and preserving, and to determine what new information was needed.

Because of the widespread interest in the subject, the Secretary appointed an Expert Panel in 1973 to assess the data concerning the presence of nitrosamines in foods, to evaluate the public health significance and specific problems identified with the use of nitrites in foods, and to determine if alternate methods of processing were available.

Agriculture, Rural Development, and Related Agencies Appropriations for Fiscal Year 1979: Hearings before a Subcomm. of the Senate Comm. on Appropriations, 95th Cong., 2d Sess. 2936, 2937 (1978) (Final Report on Nitrites and Nitrosamines to the Secretary of Agriculture by the Expert Panel on Nitrites and Nitrosamines).

One conclusion of the new round of studies was that nitrosamines are formed in nitrite-cured bacon when it is fried at high temperatures, particularly if it is cooked until crisp. As a result, in 1978, the USDA promulgated revised regulations that reduced the permissible levels of nitrite in bacon, required that other additives be used to lessen the likelihood that nitrosamines would form, and established procedures for testing bacon to ensure that it contains no confirmable levels of nitrosamines after cooking. 9 C.F.R. § 318.7(b) (1980); see American Meat Inst. v. Bergland, 459 F.Supp. 1308 (D.D.C.1978).

Another, more tentative, conclusion of the scientific studies on nitrate and nitrite use was stated in 1978 by Paul Newberne of the Massachusetts Institute of Technology. The Newberne Report determined that nitrites themselves caused cancer in laboratory animals, even if nitrosamines had not formed prior to ingestion. This report prompted a wave of criticism from the meat industry on the one hand, and resulted in increased pressure on the USDA to completely ban the use of nitrites on the other. The Department resisted these pressures, however, finding that greater scientific study was required. 1 See Schuck v. Butz, 500 F.2d 810 (D.C.Cir.1974).

As the USDA and FDA studies continued, public awareness of the problem resulted in increased consumer demand for nitrate and nitrite-free products. USDA regulations, however, prohibited the production, sale or distribution of nitrate and nitrite-free products under their traditional names such as frankfurters, bacon, etc. As a result, consumers complained of some difficulty in identifying or finding the products they desired.

The Food Safety and Quality Service of the USDA responded to these complaints on April 28, 1978, by publishing a notice of proposed rulemaking in the Federal Register. 43 Fed.Reg. 18,193 (1978). In this notice, the USDA proposed to amend the federal meat inspection regulations to permit the sale of nitrate and nitrite-free products under their traditional names, provided that certain labeling and quality requirements were met.

In the sixty-day comment period following notice of the proposed rule, the USDA received 365 comments from individual consumers, consumer organizations, and industry and trade associations. In addition, the USDA consulted the National Advisory Committee on Meat and Poultry Inspection about the proposal and the comments. On June 14, 1979, the USDA issued a Final Impact Statement on the proposed rule, detailing the need for the rule, the options considered, and the expected impact of its implementation. On August 21, 1979, the USDA promulgated the final regulation, to be effective September 20, 1979. See 9 C.F.R. §§ 317.17(b) & (c), 318.7, 319.2. 2 The final rule provides that meat and meat products that are not cured with nitrates, nitrites or other preservatives may be sold under their traditional names, so long as the word "Uncured" appears on the label as part of the product name and the label states: "No Nitrate or Nitrite Added" and "Not Preserved-Keep Refrigerated Below 40o F. At All Times." In addition, the regulation requires that the uncured products be similar in size, flavor, consistency and general appearance to the products commonly prepared with nitrate or nitrite. 3

II

On September 20, 1979, the National Pork Producers Council, a trade organization representing approximately 92,500 United States pork producers, together with three members of the United States House of Representatives, filed this lawsuit challenging the regulations. The National Independent Meat Packers Association, a trade association representing approximately 300 meat packers, was subsequently granted leave to intervene as a party plaintiff. The plaintiffs sought declaratory and injunctive relief.

On February 12, 1980, the district court entered a final order permanently enjoining the government from enforcing or applying the challenged regulations. 4 The court rested its decision on four grounds:

(1) The Secretary of Agriculture acted arbitrarily and capriciously because he failed to consider whether consumers would be subjected to botulism poisoning if they were to handle uncured products in the fashion in which they now handle cured products, and because there was no rational basis in the record for assuming that the required labels would effectively prevent confusion between the two types of products.

(2) The Secretary exceeded his authority under the Federal Meat Inspection Act, 21 U.S.C. § 601 et seq., because the regulation was promulgated for the unlawful purpose of promoting or encouraging a market for nitrate and nitrite-free products.

(3) The Secretary exceeded his authority because the similarity requirement bore no rational relationship to the purposes of the Federal Meat Inspection Act and because it constituted a subjective standard of identity rather than an objective recipe or formula.

(4) The Secretary failed to comply with...

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