This lawsuit was filed on September 19, 1984.
The informal hearing was held on October 11 and 12, 1984. The results of that hearing are under review by the agency. No timetable for further action, if any, has been forthcoming.
The Administrative Procedure Act requires each agency to "proceed to conclude a matter presented to it" "within a reasonable time." 5 U.S.C. § 555(b). Reviewing courts have the authority to "compel agency action unlawfully withheld or unreasonably delayed." 5 U.S.C. § 706(1). In deciding whether agency action has been "unreasonably delayed," the court "should consider the nature and extent of the interests prejudiced by delay, the agency justification for the pace of decision, and the context of the statutory scheme out of which the dispute arises." Public Citizen Health Research Group v. Comm'r of Food and Drug, 238 U.S. App. D.C. 271, 740 F.2d 21, 35 (D.C. Cir. 1984). "Delays that might be altogether reasonable in the sphere of economic regulation are less tolerable when human lives are at stake." Public Citizen Health Research Group v. Auchter, 226 U.S. App. D.C. 413, 702 F.2d 1150, 1157 (D.C. Cir. 1983).
There is ample legal authority for the action for which Public Citizen petitioned the Secretary. Under both the Public Health Service Act's authorization for regulations to control communicable diseases, 42 U.S.C. § 264, and the Food, Drug and Cosmetic Act's provisions for the control of adulterated foods, 21 U.S.C. § 342, the Secretary has both the authority and the heavy responsibility to act to protect the nation's health in situations such as this one.
The facts here speak for themselves and need little elaboration. Officials at the highest levels of the Department of Health and Human Services have concluded that certified raw milk poses a serious threat to the public health. Leading health organizations are unanimous in proposing that sales of any raw milk should be banned.
The Food and Drug Administration has twice proposed, in 1973 and 1983, that all milk in interstate commerce be pasteurized. Hundreds of cases of serious gastrointestinal infections have been reported since the ban on raw milk sales was first proposed.
This Court is not asked to decide the substantive merits of a ban on raw milk sales.
The only issue here is the reasonableness of the agency's delay, and the only remedy sought is a judicially established schedule for agency action.
The Department's justification for its continued delay is lame at best and irresponsible at worst. In its papers filed in this lawsuit, the Department admits that "the consumption of 'certified' raw milk . . . has been linked to the outbreak of serious disease. . . ." McGarrahan Declaration at para. 7. In the face of overwhelming evidence, the Department insists, however, that further study is warranted because "the issue is controversial and complicated."
Since its own top health officials
are on the record to the contrary, this assertion can be given no credence. As to the Department's related assertion that it needs time to study regulatory options such as a warning label on milk bottles in lieu of a ban on sales, such study has been underway for nearly two years, and still no agency action has been proposed.
The Department also asserts that interstate sales of certified raw milk are "negligible." While it has offered no facts supporting this, any such figures are meaningless if the risk per sale is high, as the Department's own statistics indicate.
The volume of interstate sales also does not address the safety of intrastate sales, which plaintiffs also have proposed to ban.
"When the public health may be at stake, the agency must move expeditiously to consider and resolve the issues before it." Public Citizen Health Research Group v. Commissioner of Food and Drugs, 740 F.2d at 34. The Department has wholly failed to meet that mandate here.
Accordingly, the plaintiff's motion for summary judgment is granted and the defendant's motion for summary judgment is denied. An appropriate Order setting out a schedule for agency action is filed herewith.
Upon consideration of the parties' cross-motions for summary judgment, the briefs of counsel, and the entire record herein, for reasons stated in an accompanying Memorandum, it is hereby
ORDERED that the plaintiffs' motion for summary judgment is granted and the defendant's motion for summary judgment is denied, and judgment is entered for plaintiffs, and it is further
ORDERED that defendant shall publish within 60 days a proposed rule reflecting its decision on plaintiffs' petition, and shall proceed expeditiously to complete any ensuing rule-making proceeding.