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December 31, 1986

PUBLIC CITIZEN, et al., Plaintiffs,
Margaret HECKLER, Defendant

The opinion of the court was delivered by: JOHNSON


 The plaintiffs in this case are Public Citizen, a non-profit public interest organization whose objectives include improving the public health; Sidney M. Wolfe, M.D., Director of Public Citizen Health Research Group; the American Public Health Association, a nonprofit public health professional society; and George J. Drabble, a resident of California, where most raw milk is produced and consumed. Plaintiffs challenge as arbitrary, capricious, and not in accordance with law, the denial by the Secretary of Health and Human Services ("HHS" or "the Secretary") of Public Citizen's citizen petition for the issuance of a rule banning the sale of unpasteurized milk *fn1" in the United States. Plaintiffs also challenge the Secretary's failure to terminate a 1974 stay of a 1973 Food and Drug Administration ("FDA") regulation that revised the existing standards of identity for milk and milk products moving in interstate commerce, and in effect prohibited the sale of all unpasteurized milk in interstate commerce. 38 Fed.Reg. 27924 (Oct. 10, 1973, stayed in 39 Fed.Reg. 42351 (Dec. 5, 1974)). On December 5, 1974, the regulation was stayed as to the sale of only certified raw milk *fn2" pending a public hearing on the safety of certified raw milk which was to be held by the FDA. Although evidence adduced at that hearing conclusively shows, and the Secretary now concedes, that the consumption of certified raw milk presents a serious risk to human health, the 1974 stay has not been lifted.

 Plaintiffs request this Court to compel HHS to (1) complete the thirteen year old pending rulemaking proceeding to require that all milk and milk products sold in interstate commerce be pasteurized; and (2) initiate a new rulemaking proceeding banning both interstate and intrastate sales of raw milk. The case is currently before this Court on the parties' cross-motions for summary judgment.

 After careful consideration of the cross-motions for summary judgment, the pleadings, supporting and opposing memoranda, and the entire administrative record, this Court concludes that partial summary judgment must be entered for HHS on the issue of HHS's failure to terminate the 1974 stay of its 1973 pasteurization requirement, and partial summary judgment must be entered for plaintiffs on the issue of HHS's denial of Public Citizen's petition for new rulemaking.


 On October 10, 1973, in a standard of identity proceeding, the Food and Drug Administration adopted a regulation pursuant to section 401 of the Food, Drug and Cosmetic Act, 21 U.S.C. § 341 (1982), that required that all products labeled "milk" moving in interstate commerce be pasteurized. 38 Fed.Reg. 27924 (October 10, 1973). The Association of Medical Milk Commissions, Inc., the Certified Milk Producers Association of America, Inc., and two of the three dairies that produce certified raw milk formally objected to the regulation. They asserted that certified raw milk (as opposed to uncertified raw milk or raw milk) was a safe product, and that section 401 of the Federal Food, Drug and Cosmetic Act did not give the Commissioner authority to establish a standard of identity solely for health reasons.

 In response to this objection, the FDA ruled that because substantial issues of fact existed with regard to the safety of certified raw milk, the 1973 requirement would be stayed pending a public hearing on the matter. 39 Fed.Reg. 42351 (December 5, 1984). The pasteurization regulation remained in effect with regard to non-certified raw milk. In the stay order, the FDA Commissioner noted that section 361 of the Public Health Service Act, 42 U.S.C. 264 (1982), as well as section 401 of the Federal Food, Drug, and Cosmetic Act, authorizes the FDA to enact a pasteurization requirement. The Commissioner also stated that "if certified raw milk is found to contain harmful bacteria or to be in violation of other provisions of the Federal Food, Drug and Cosmetic Act, appropriate action will be taken." Id.

 From 1974 to 1982 the FDA collected and evaluated scientific and medical information to determine if the outbreak of certain diseases was associated with the consumption of certified raw milk. The FDA worked closely with the Center for Disease Control ("CDC"), a branch of HHS, and encouraged the states to test milk and milk products for bacteria or microorganisms and to report outbreaks of milk-borne disease to the CDC.

 The process of collecting and reviewing data and information led the FDA to conclude that the consumption of certified raw milk and all forms of raw milk and raw milk products was linked to the outbreak of serious disease. *fn3" In 1982, the FDA began drafting a proposed regulation banning the interstate sale of all raw milk and raw milk products.

 The FDA's proposal received widespread support from others within HHS. For example, in a February 1984 memorandum, HHS's Assistant Secretary for Health Edward Brandt, Jr., presented "further compelling evidence on the association of S. Dublin salmonella and the consumption of raw milk." Plaintiffs' Exhibit I. Likewise, in May 1983, the Director of the Center for Disease Control stated that "because the accumulated evidence indicates that unpasteurized [raw] milk is inherently unsafe, the Center for Disease Control supports pasteurization of milk and other dairy products." Plaintiffs' Exhibit J. The Director of CDC further indicated that CDC can conceive of no practical way raw milk can assuredly be safely marketed." Id.

 In a February 1984 memorandum, the Chief of the Bureau of Foods Epidemiology and Clinical Toxicology Division provided emphatic statistical support for the FDA's proposed regulation. Following a review of data provided by the California Department of Health Services, the memorandum concluded that an individual who consumed certified raw milk produced by the Alta-Dena dairy was 51 times more likely to be infected with S. Dublin than an individual who consumed pasteurized milk. Plaintiffs' Exhibit K.

 Public Citizen filed a citizens petition with the FDA on April 10, 1984, requesting a ban on all domestic sales of raw milk and raw milk products. Plaintiffs' Exhibit L. The Secretary did not rule on the merits of the petition and by letter to Dr. Sidney Wolfe of Public Citizen, she stated that the matter "is under active consideration." No schedule for reaching a conclusion was given, but the Secretary indicated she would hold a public hearing on the matter. Plaintiffs' Exhibit M.

 In a second letter to Dr. Wolfe, the Secretary indicated that the certified raw milk issue "has been periodically reviewed within the Department for many years without definitive resolution." Id. Again, she refused to indicate when a resolution might be made. Plaintiffs filed suit in the District Court for the District of Columbia on September 19, 1984, to compel the Secretary to respond to the petition for a ban on raw milk sales in a timely fashion. Public Citizen v. Heckler, 602 F. Supp. 611 (D.D.C.1985).

 In accordance with the Secretary's first letter to Dr. Wolfe, on October 11 and 12, 1984, an informal hearing was held by HHS on two issues: (1) whether the consumption of raw milk is a public health concern; and (2) if so, whether requiring pasteurization of all raw milk is the most reasonable regulatory option. The notice of hearing published in the Federal Register stressed that the purpose of the hearing was to develop an administrative record upon which agency action would be based. 49 Fed.Reg. 31066 (August 3, 1984).

 The Secretary did not suggest in the notice that there was any question of who, as between the federal government and the individual states, should regulate raw milk. No public comment was solicited on that issue. Over 25 state and local public health departments submitted comments to the FDA supporting a federal ban on raw milk sales. Not a single state or local government agency contended either that raw milk was not a significant public health problem or that pasteurization was not the proper regulatory approach to the danger posed by raw milk. In fact, the National Conference on Interstate Milk Shipments, whose members consist of the milk regulatory agencies of the 50 states, had adopted an ordinance calling for the pasteurization of all Grade A milk and milk products.

 Comments opposing a pasteurization requirement included several witnesses' testimony that in the absence of a definitive case-control study, there was no way to determine whether the apparent association between drinking raw milk and being infected by harmful microorganisms was causal and encouraged HHS to sponsor such a study. Other proponents of raw milk testified that raw milk offers nutritional benefits that are destroyed by pasteurization and that raw milk tastes better than pasteurized milk.

 The American Academy of Pediatrics, the National Association of State Departments of Agriculture, the Association of State and Territorial Health Officials, the United States Conference of Local Officials, the National Conference for Food Protection, the American Veterinarians Medical Association, the National Milk Producers Associations, the National Conference on Interstate Milk Shipments, the Association of Food and Drug Officials, the National Dairy Counsel, the American Society for Microbiology, the Milk Industry Foundation, the Mid-American Dairymen's Association, and others, all supported the pasteurization requirement. These witnesses argued that the risks associated with the consumption of raw milk, even certified raw milk, heavily outweigh any benefits from its consumption.

 Some witnesses suggested that labeling would be an appropriate alternative to a ban. Others stated that because raw milk is often consumed by the very young, the elderly and the infirm, labeling would not adequately protect them from the inherent risk associated with the product.

 No organization or individual commented or testified at the FDA hearing that the states are in a better position to respond to the problems posed by raw milk consumption than is the federal government. *fn4" Evidence in the record of the inability of certain states to overcome the resistance of the certified raw milk producers and deal with the problem at the state level suggests just the opposite. The record shows that the individual states in fact favored federal regulation.

 No individual or organization commented or testified that because of the relatively small percentage of interstate sales of raw milk in comparison to intrastate sales the FDA should be prevented from banning interstate sales of raw milk. The evidence did indicate that even if the incidence of raw milk consumption resulting from interstate sales were low, the risk of contracting a serious illness as a result of that consumption remained high.

 No participant in the hearing suggested that the Secretary lacked the necessary statutory authority to ban raw milk sales in the United States. That assertion was raised for the first time in HHS's litigation memoranda. In its denial letter, HHS stated that on the facts known it did not have statutory authority to impose an intrastate ban. There was no assertion made by the Secretary in her denial letter that HHS lacked authority to ban intrastate ...

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