602 F.Supp. 611 (D.D.C. 1985), Civ. A. 84-2938, Public Citizen v. Heckler
|Docket Nº:||Civ. A. 84-2938|
|Citation:||602 F.Supp. 611|
|Party Name:||Public Citizen v. Heckler|
|Case Date:||January 14, 1985|
|Court:||United States District Courts, District of Columbia|
Eric R. Glitzenstein, William B. Schultz, Alan B. Morrison, Washington, D.C., for plaintiffs.
Jacqueline H. Eagle, Dept. of Justice, Washington, D.C., for defendant.
GESELL, District Judge.
Plaintiffs Public Citizen, the American Public Health Association and others brought this suit seeking to compel the Secretary of Health and Human Services (HHS) to act on a petition asking her department to ban all domestic sales of raw milk and raw milk products. Contending that federal officials have long known of serious risks to human health from consumption of raw milk, plaintiffs contend that the Secretary has unreasonably delayed her decision in violation of the Administrative Procedure Act, 5 U.S.C. § 706(1). The case is before the Court on cross-motions for summary judgment, which have been fully briefed by the parties.
I. The Facts
The facts are essentially undisputed. Raw milk is milk that has not undergone pasteurization, the familiar process whereby harmful bacteria are destroyed by heating the milk to a point below boiling. In 1973, the Food and Drug Administration (FDA) proposed and adopted a regulation requiring that all milk moving in interstate commerce be pasteurized. 1 After receiving an objection from a producer of what is known as "certified" raw milk, 2 the FDA
stayed the pasteurization requirement as to certified raw milk but put it in effect for all other milk and milk products, as of December 5, 1974. 3 The stay order published that date states that the FDA Commissioner "still concludes that there are serious safety problems associated with certified raw milk ... and that only pasteurized milk should be shipped for beverage use in interstate commerce" but that a public hearing would be held to resolve the factual dispute over whether certified raw milk was sufficiently safe. 39 Fed.Reg. 42,351. No such hearing has ever been held, and the stay order has remained in effect.
Between 1974 and 1982, the FDA accumulated evidence of the association of certified raw milk with human disease. It concluded in 1982 that the consumption of certified raw milk had been linked "to the outbreak of serious disease." 4 In particular, as documented by the federal Centers for Disease Control, there had been a number of outbreaks of two serious bacterial diseases, campylobacteriosis and salmonellosis, which typically produce bloody diarrhea, usually lasting several days but sometimes several months. 5 On rare occasions these diseases result in death. A number of states had banned all sales of raw milk in the interim, 6 and the American Academy of Pediatrics in 1980 proposed a federal ban on its marketing.
In 1982, the FDA began drafting a proposed regulation to ban all interstate sale of raw milk and raw milk products. FDA Commissioner Arthur Hayes sent the proposed regulation to the Secretary of Health and Human Services on April 25, 1983. In an attached memorandum supporting the regulation, he concluded that consumption of raw milk "presents a significant public health problem" and that pasteurization was the...
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