By Pete Kennedy, Esq.
On August 12, the Senate Health, Education, Labor and Pensions (HELP) Committee released the manager’s package for the “Food Safety Modernization Act,” a revised version of S510. The most alarming change in the bill is one that will potentially require “hazard analysis and risk-based preventative controls” (HARPC) for any farm (unless the farm is only selling products under USDA jurisdiction) that is, selling or otherwise distributing food products of the farm that have been “manufactured/processed.” The definition of manufactured/processed in the Federal Code of Regulations (CFR) is extremely broad and includes terms like bottling, packaging and labeling [21 CFR 1.227(6)]. The HARPC provision requires that written safety plan identifying hazards that could affect food manufactured, processed, packed or held at a “food facility” and listing preventative controls that can be used to address those hazards.
The HARPC system is similar to HACCP, a food safety system currently used by various sectors of the food industyry. The HARPC plan has particular implications for raw milk producers. The United States Food and Drug Administration (FDA) would be in charge of enforcing the requirements; there is no government agency more opposed to raw milk than FDA. FDA has long wanted a complete ban on the sale and consumption of raw milk and would now have an opportunity to regulate raw milk producers out of business if S. 510 passes into law.
A blueprint of how FDA could use HARPC requirements to drive small farms into bankruptcy can be found in the USDA enforcement of HACCP against small slaughter houses and meat processing plants. John Munsell, a former owner of a meat processing plant and current manager for the Foundation for Accountability in Regulatory Enforcement, summarized how USDA puts small slaughterhouses and processing plants out of business:
The HARPC requirement could do tremendous damage to the local food system. S. 510 represents a major threat to food freedom of choice. Please contact your Senator and urge him to either vote for the Tester-Hagen amendment (which would exempt small farms and processing plants) or kill the bill.
In a complex federal district court ruling, Judge Mark W. Bennett refused to grant a motion by the United States Food and Drug Administration (FDA) to dismiss a lawsuit filed against the agency by the Farm-to-Consumer Legal Defense Fund (FTCLDF) and eight other named plaintiffs. The lawsuit argues that federal regulations (21 CFR 1240.61 and 21 CFR 131.10) prohibiting raw milk for human consumption in interstate commerce are unconstitutional as applied to FTCLDF’s members and the other plaintiffs named in the suit.
In his August 18 decision, Judge Bennett denied part of FDA’s motion to dismiss while reserving judgment on the remainder. As part of his ruling, the judge ordered proceedings in the case to be stayed sixty days to allow plaintiffs time to decide whether to file a “citizen petition” with FDA. The petition would ask FDA to clarify its interpretation of the authorizing statutes and regulations giving the agency power to ban raw milk for human consumption in interstate commerce. If plaintiffs choose to file the citizen petition, the court would continue to delay the suit until the administrative proceedings were completed or until FDA failed to take action within the time the law requires. If plaintiffs declined to pursue the citizen petition, Judge Bennett indicated the court would reconsider FDA’s motion to dismiss. In Judge Bennett’s view, the main question FDA needs to answer in the petition process is “whether § 1240.61 applies to and proscribes the conduct of (1) persons who travel from one state, where it is not legal to purchase raw milk, to another state, where it is legal to purchase raw milk, legally purchase raw milk, then return to the original state where they consume the raw milk themselves or give it to their friends or family members; or (2) a principal and agent who agree that the agent will obtain raw milk out-of-state, where it is legal to do so, and to deliver it to the principal in the principal’s home state, where sales of raw milk are not permitted; or (3) a producer of raw milk who sells raw milk in an intrastate transaction to persons that he knows are from out of state.”
All of the individually named plaintiffs in the lawsuit fit into one of the three scenarios described above. Section 1240.61 provides in part, “No person shall cause to be delivered into interstate commerce or shall sell, or otherwise distribute, or hold for sale or other distribution after shipment in interstate commerce any milk or milk product in final package form for direct human consumption unless the product has been pasteurized. . . ”
Judge Bennett sees the citizen petition as a way to resolve the question of “whether the plaintiff’s conduct involves or affects ‘interstate commerce’ sufficiently to fall within the proscriptions of § 1240.61, and, still more specifically, whether the plaintiffs’ conduct constitutes ‘delivery [of raw dairy products] into interstate commerce’ or ‘distribution’ of raw dairy products after shipment in interstate commerce.”
Plaintiffs have survived the first round in the case. They have until October 18 to determine what their next course of action will be.