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Milk quality: Who sets the rules?

Ben Yale Published on 07 April 2011

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From the first colonies up through the present, the regulation of food sanitation, especially milk and milk products, has been a state -and local issue. Public health regulations were among the earliest Colonial laws. Early rules dealt primarily with public outbreaks of disease.

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Regulations on food, including milk, evolved as the percentage of the population self-sufficient in the production of food shrank and the percentage who purchased their food grew.

Although there is evidence of earlier regulations directed at food, we know that the General Court of Massachusetts (a legislature) passed a law in 1784 making it unlawful to sell unwholesome food. Histories of food regulation in the other colonies were much the same.

The regulation of food safety arises out of the police power inherent in government. The fundamental role of government is to protect its citizenry. That obligation goes beyond protection against crime, invasion and unrest, including threats to health and safety such as fire, natural calamity and disease. Prevention is part of that protection.

Although Congress has passed legislation regarding food health, notably the Food and Drug Act, the actual regulation of milk production and processing has remained a local issue. Even today, dairy producer permits are issued by state or local authorities under state, not federal law.

Along with the obligation to protect citizens physically, there is also an inherent obligation to protect the economic interests of the community as well. Laws such as zoning, eminent domain and others are examples of economic power for the general or public good.

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The long history, even before Western Europeans came to America, of cities, through guilds and unions, authorizing franchises for different trades arises out of this same general viewpoint. The common thread of economic protection and health and welfare is the belief that local is always better for the community.

Even in more modern times, such as the last half of the 20th Century, American cities and states have passed laws whose intent was to favor the local, indigenous business and farmer over those from other states, under the guise of protecting its citizenry.

Though both economic promotion and police powers are legitimate government functions, the American Constitution gave federal government control over interstate commerce (by decision virtually all commercial activity is interstate), but left the police powers to the states and their subdivisions.

After the War of Independence, the various colonies organized themselves into a loose federation under a document called the Articles of Confederation. As national governance, it had many flaws.

Although it provided for a national government, the absolute sovereignty of the individual states was assured. That included the ability of those states to impose burdens on the sale of goods and services from the sister states as if they were foreign countries.

Maryland and Virginia negotiated a compact over regulating trade on the Potomac. The success of this effort became the catalyst to consider a new way to order the states into a national government. A convention was called for in 1786.

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Over the next year, the delegates drafted the Constitution of the United States. This document gave the new federal government specific or “enumerated” powers. Among those, Congress had the authority to regulate commerce among the states.

After the Constitution was passed, the states ratified 10 amendments, known as the Bill of Rights. The last of these, the 10th Amendment, provided, “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.” This meant that the police power enjoyed since the beginning remained with the states.

With the history leading to the Constitution as a backdrop, early court cases interpreted the power of Congress to regulate interstate commerce to mean that there was no regulation absent an act by Congress. This power, sometimes called the Dormant Clause, meant that no state could interfere with commerce absent Congressional action.

As the commerce between the states grew and technology virtually erased distance and borders, these two parts of the Constitution, commerce power held by the federal government and police power held by the states, clashed.

At the Supreme Court level, most of these disputes involved milk regulation, largely because of the sanitation issues unique to milk coupled with its economic value.

As an example, the city council of Madison, Wisconsin, legislated that no bottled milk could be sold within the city unless pasteurized within five miles of the city limits and from farms within 25 miles of the city limits. This area included most of Dane County, a major milkshed.

More than 500 farms were located within the territory which could supply the three bottling plants located within the five-mile radius. At that time, this milkshed was not of “Grade A” quality by the standards recommended by the United States Public Health Service, and no milk labeled “Grade A” was distributed in Madison.

Less than a hundred miles to the south of Madison, the Dean Milk Company operated two plants which received milk from producers in northern Illinois and southern Wisconsin. Those plants and producers were “Grade A,” subject to inspection by the Chicago Department of Health, which patterned its regulations on the Pasteurized Milk Ordinance (PMO). Madison’s regulations, too, were patterned after the PMO, but it claimed they were more rigorous.

When Dean Milk sought to market milk in Madison, it was denied a permit. In 1950, it sued in federal court, claiming that Madison was imposing limitations on the interstate commerce of milk. Madison defended, claiming it was exercising its police power.

The case made it to the Supreme Court. The court, relying on earlier decisions over the same conflict in milk, held that the Madison ordinance violated the Commerce Clause and was thus invalid. In doing so, it noted that the U.S. Public Health Service had developed a system that called for local inspection without geographic limits.

This latter system was relatively new. The tension between the local government’s obligation to protect its citizenry from unhealthy food and the out-of-town producer’s right to market products in that town had been growing in intensity as milk could move farther and farther.

In response, health and sanitary regulators from various states had routinely held conferences to adopt a model pasteurized milk ordinance for all to use. That was not enough. The issue of local enforcement and out-of- state sources remained unresolved.

In 1946, the Conference of State and Territorial Health Officers requested the U.S. Public Health Service (PHS) to develop a plan for the certification of interstate milk shippers. The meeting was held in 1950.

This first interstate milk shippers conference laid the groundwork for the unique federal, state and local relationship present today in milk sanitation. It did so by preserving the police powers in the states and respecting the commerce power held by Congress.

The resulting PMO had no geographical limitation on either the farms or plants. Instead, the standards were solely based upon criteria under the ordinance. The locality could choose the level of compliance, or score, with the standards.

Health authorities where the milk is produced or processed inspect these facilities and issue scores. These scores are published. The receiving city or state can rely upon those inspections and scores because the United States Public Health Service routinely spot-checks the local ratings.

Today, the PMO is universal throughout the United States and is even applicable on farms and plants as far away as Greece and Spain who market milk into the United States. Every odd year, the National Conference on Interstate Milk Shippers Conference meets to consider modifications to the PMO.

Delegates include representatives from the U.S. Public Health Service, state and local health departments, academia, milk producers, milk processors and milk haulers. The 33rd conference is scheduled for April 28 – May 4, 2011, in Baltimore, Maryland.

But that is not enough for some. Through its authority under the Commerce Clause, Congress has instituted additional regulations on milk producers and processors. The Food Safety Modernization Act of 2010 amends the Food, Drug and Cosmetic Act (FDCA).

The amended FDCA gives the FDA broader and greater powers over food production and processing. While without regulations we do not know all the implications, specific language in the FDCA and recent FDA activity gives a fairly clear idea of where milk production regulation is heading.

The FDCA has broadened the application of the term “adulterated” by adding to the definition to create a degree of vagueness. Traditionally, agencies have used the vagueness of the statute to eliminate any legal defense of their actions in enforcing the law. The way in which FDA finalizes these definitions will be keenly watched.

By mid-2012, the FDA, in conjunction with the USDA and local and state agencies, is to develop regulations regarding intentional adulteration of food. Dairy farms are included in this set of regulations. Traditionally, antibiotics in milk have been considered “adulteration.”

The standard for considering whether such is intentional will no longer be credible evidence, such as test results, but “reason to believe,” which could be a history of positive tests. In this way, it could exercise authority to shut down a dairy farm until it was satisfied there was no problem. This could last days or weeks.

In the meantime FDA wants to spot-test dairy farms for antibiotic residue using new technology that can identify even a trace of most classes of antibiotic and other drug residues.

Although the incidence of antibiotics in milk loads is down (less than one-twentieth of one percent of loads tested positive in 2010) and trending down, and the number of cull cows that have antibiotic residue when slaughtered is relatively low (788 out 2.6 million) and also trending down, FDA sees these low numbers as warning signs of greater misuse of drugs on the farm.

One way or another, it will be tougher on antibiotic use on the dairy farm.

The debate of whether it is necessary or not will go on, but this regulatory oversight of the local dairy farm will come not from the local government’s police power, but the federal government’s power under the Commerce Clause. PD

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Ben Yale
Attorney
Yale Law Office

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