American Meat Institute v. Bergland, Civ. A. No. 78-1642.

• Decision Date: 31 October 1978
• Docket Number: Civ. A. No. 78-1642.
• Parties: AMERICAN MEAT INSTITUTE, Plaintiff, v. The Honorable Robert S. BERGLAND et al., Defendants.
• Court: U.S. District Court — District of Columbia

459 F. Supp. 1308

AMERICAN MEAT INSTITUTE, Plaintiff, v. The Honorable Robert S. BERGLAND et al., Defendants.

Civ. A. No. 78-1642.

United States District Court, District of Columbia.

October 31, 1978.

COPYRIGHT MATERIAL OMITTED

Alan H. Kaplan, Richard S. Morey, Glenn E. Davis, Kleinfeld, Kaplan & Becker, Washington, D. C., for American Meat Institute.

Glenn V. Whitaker, Atty., Dept. of Justice, Washington, D. C., for defendants.

MEMORANDUM OPINION

BARRINGTON D. PARKER, District Judge:

In this proceeding the American Meat Institute (AMI), requesting declaratory and injunctive relief, seeks judicial review of certain actions taken by the Secretary of Agriculture and other officials¹ of the United States Department of Agriculture (Department or USDA) in the administration of the Federal Meat Inspection Act, 21 U.S.C. § 601, et seq.. In particular, AMI challenges the promulgation and the execution of a recently enacted rule which provides procedures for monitoring the processing of bacon and regulating the presence of nitrosamines in it, 43 Fed.Reg. 32137 (July 25, 1978), 9 C.F.R. § 318.7(b). The matter is before the Court on plaintiff's motions for preliminary injunction and partial summary judgment. The defendants have filed a motion to dismiss which will be treated as a motion for summary judgment inasmuch as it relies upon affidavits and matters outside the pleadings, Rule 12(b) Fed.R.Civ.P. The Court has reviewed the extensive record and has had the benefit of counsel's oral argument. For the reasons set forth the Court determines that plaintiff's request for relief should be denied, that summary judgment be entered for the defendants and the complaint dismissed.

Introduction

Nitrites are chemicals which have been used to process food for centuries. When added to fish, poultry and meat products they react with bacteria and result in a pink or reddish color. More significantly, however, nitrites are added to meat and other products to retard spoilage and to reduce the hazard of botulism, a deadly form of food poisoning. In recent years, however, reliable studies have confirmed that the use of nitrites in cured meats produces nitrosamines, which when consumed by laboratory animals cause cancer.

The Federal Meat Inspection Act requires the Department to condemn all "adulterated" meat products. One of its definitions of adulterated meat is that which "bears or contains any poisonous or deleterious substance which may render it injurious to health," 21 U.S.C. § 601(m). The Department has concluded that cooked bacon containing nitrosamines at confirmable levels is such an adulterated product on the basis of the studies in experimental animals.

The regulation at issue, 9 C.F.R. § 318.7(b),² concerns the use of nitrites in the processing of bacon. The regulation has two subparts. The first, 7(b)(1) requires that 120 parts per million (PPM) sodium nitrite or an equivalent amount of potassium nitrite (148 PPM) and 550 PPM sodium ascorbate or sodium erythorbate (isoascorbate), be used in the preparation of bacon. The second, 7(b)(2), which is the concern of this litigation, sets forth a sampling and analysis procedure for nitrosamine detection in cooked bacon and also specifies retention criteria for bacon found to contain confirmable levels of nitrosamines.

I. The Background

In recent years the USDA has devoted increasing attention to the use of nitrites and the presence of nitrosamines in meat products. In 1973, the Secretary of Agriculture appointed an expert panel of scientists from USDA, the Food and Drug Administration (FDA) and private industry to advise on the use of nitrites in meats. Based on data from the expert panel and other sources that nitrites interact with other compounds to form nitrosamines in bacon, the USDA on November 11, 1975, noticed proposed rulemaking to limit the amount of nitrite added to bacon to 125 PPM and to require the use of sodium ascorbate or sodium erythorbate at approximately 550 PPM. 40 Fed.Reg. 52,614, 52,616. The notice also observed that "a special problem exists with bacon. In this regard, the Department has been assured by the meat industry that it is accelerating studies underway concerning processing procedures . . . directed toward preventing nitrosamine formation in fried bacon." Id. In September, 1977, the panel recommended the adoption of a 120 PPM sodium nitrite level in bacon as well as the mandatory use of ascorbate or erythorbate at 550 PPM (120/550).

On October 18, 1977, the USDA, noting the carcinogenic potential of nitrates and nitrites, sought information from the meat industry as to whether their use in bacon production results in the formation of carcinogenic nitrosamines during cooking and preparation for eating. The notice pointed out that the Department was interested in determining whether the use of nitrites in the production of bacon should be banned. 42 Fed.Reg. 55,626.

In addition to earlier submitted information, the American Meat Institute submitted a rulemaking comment entitled "Response for Bacon," March 17, 1978. Attached to and referenced was a cooperative study (Reference 17), conducted in 10 commercial bacon production plants.³ The study stated in part that "it was a test of the probable commercial result to be expected upon adoption of the proposed USDA regulations, which call for production of bacon with 125 mg ingoing sodium nitrite and 550 mg of sodium erythorbate or sodium ascorbate . . .." The cooperative study reported that pork bellies were pumped with determined amounts of nitrite and erythorbate or ascorbate shown for each variable, ranging from 0 PPM to 120 PPM sodium nitrite and 0 to 550 PPM erythorbate or ascorbate. Appropriate production amounts of other curing ingredients were used and the pork bellies were then processed with the normal cook-smoke method of each plant. After the bacon samples were stored for three weeks under refrigeration, they were then tested for nitrosamines by combined gas chromatography (GC) and mass spectrometry (MS). This testing procedure is required under § 318.7(b)(2) and as stated in the study "is widely regarded as the best available technology, and is deemed to be accurate and reproducible at levels at 10 . . . Parts per billion or more."

The cooperative study included the following conclusions:

1. None of the samples tested were found to be positive at a level of 10 ppb or more of nitrosopyrrolidine.

2. Lowering the ingoing level of sodium nitrite from 120 ppm to 80 ppm does not appear to reduce the occurrence of very low levels (less then 10 ppb) of nitrosopyrrolidine.

3. Processing variables, such as salt level, cook-smoke cycle, etc. showed no influence on the results obtained.

In the commentary to the "Response for Bacon," the AMI stated at page 3 with respect to the results:

Results of the 10-plant study showed that about 90 percent of the bacon samples were free of nitrosamines, after frying. While tests showed that a few samples did contain nitrosamines, the amounts (10 parts per billion or less) were so small as to raise questions about reliability of the results. Based on this and other information . . ., the USDA Expert Panel endorsed industry's position that bacon be produced with 120 ppm nitrite and 550 ppm ascorbate or isoascorbate.

In addition to the above, AMI submitted other documents and studies establishing that the addition of ascorbates to bacon and levels of 120 PPM sodium nitrite would produce bacon yielding no detectable levels of nitrosamines after cooking.⁴ Indeed, prior to March 17, 1978, Richard Lyng, President of AMI, and Dr. John Birdsall, its Scientific Director and Secretary, had recommended to USDA the adoption of the 120/550 PPM levels of nitrite and ascorbate. In October, 1977, Richard Lyng, on behalf of AMI wrote to the Food Safety Quality Service of the Department:

We believe that adequate data have been submitted to demonstrate the effectiveness of reduced nitrite (120 ppm) and increased ascorbate or erythorbate (550 ppm) in producing bacon which when fried contains nonconfirmable quantities of nitrosamines.⁵

Thereafter, on November 3, 1977, President Lyng, again representing the AMI, formally petitioned "the Department of Agriculture to put into effect immediately the amount of nitrite added to bacon to 120 parts per million and to require the addition of 550 parts per million of ascorbate." The petition itself stated in part that such action "would eliminate or reduce significantly the formation of nitrosamines."

II. The Regulatory Scheme

The specific level of exposure to nitrosamines which may cause cancer in humans is unknown. Furthermore, some persons are more susceptible to cancer induction than others. Rejecting various mathematical models designed to assess potential cancer risks to humans, USDA has made a determination that bacon containing confirmable levels of carcinogenic nitrosamines is adulterated, and should not be made available to the public. Acting on the submissions of the AMI and others the Department concluded, first, that use of the 120/550 PPM levels required by § 318.7(b)(1) will produce bacon which when cooked will not contain nitrosamines at confirmable levels; and second, that repeated findings of nitrosamines at confirmable levels in cooked samples is sufficient evidence of poor quality control and nonadherence to the required levels by a bacon producer, as specified in § 318.7(b)(1).

The challenged section, 7(b)(2), requires sampling and analysis for nitrosamine detection in cooked bacon and specifies retention criteria for bacon found to contain confirmable levels of nitrosamines.⁶ A USDA inspector randomly selects a bacon sample from a plant's production lot. The sample is refrigerated 21 days before testing. It is then fried under controlled conditions and later analyzed by a Thermal Energy Analyzer (TEA) to determine evidence of nitrosamines at confirmable levels. If none is found, no further...