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From: Food Quality & Safety magazine, April/May 2010

A Realistic Approach to Food Safety Regulation

Rather than establishing a single regulatory body, let’s create a foodborne illness database

by Eric D. Hargan

Eric D. Hargan

The United States is often said to have a two-pronged food safety regulatory system, with the U.S. Department of Agriculture (USDA) responsible for inspecting meat, poultry, and eggs, while the U.S. Food and Drug Administration (FDA) oversees the other fresh and processed foods that make up 80% of the food supply. This system leads to frequently cited inspection gaps and overlaps that critics say contribute to food safety problems: The FDA oversees fresh eggs, but the USDA inspects processed egg products; the USDA is accountable for the quality of pepperoni pizza, while the FDA is responsible for ensuring the quality of cheese pizza. And the list goes on, to the merriment and/or consternation of Congress, regulated industry, and the food-buying public.

Actually, U.S. food safety inspection is even more complex than the system outlined above. A 2008 study by the Government Accountability Office (GAO) identified 15 different federal agencies responsible for food safety. For example, beyond the roles of the USDA and FDA:

  • The Environmental Protection Agency sets limits on the amount of pesticide residues that are allowed in food.
  • The National Marine Fisheries Service, within the Department of Commerce, inspects seafood safety and quality.
  • The Department of Homeland Security, through its Customs and Border Protection agency, inspects, and can refuse entry to, imported foods and food products.
  • The Centers for Disease Control and Prevention are charged with monitoring, identifying, and investigating foodborne disease outbreaks and issues.
  • Each of the 50 states has its own statutes, regulations, and agencies for regulating and inspecting the safety and quality of food products.

‘Modernization’ Push

Increased media reporting of food-related illnesses—with some sources claiming 70 million cases each year—followed by highly publicized product recalls has created the widespread perception that this multi-level system of food safety regulation is inadequate. It is therefore not surprising that, with the Obama administration’s inclination toward more extensive business regulation, U.S. Agriculture Secretary Tom Vilsack has called for a “modernization” of the food safety system, the ultimate goal of which is a single inspection agency to oversee all the food entering and produced in the United States. This is not a new viewpoint; in fact, legislation calling for such an agency has regularly been introduced into Congress during the past decade.

The Bush administration steadfastly opposed such an approach, labeling it counterproductive in terms of cost, efficiency, and effectiveness. But with the USDA behind it, and with the FDA’s new leadership calling for a proactive use of public health standards to regulate the entire “food chain” from production through distribution to consumption, the food production industry must begin to consider seriously what a single safety agency would look like—and how well it might function.

An interesting insight into these issues was provided by the GAO study noted earlier. Commissioned by congressional leaders, the study examined the effectiveness of reorganized food safety systems in seven countries or regions outside the United States, areas in which consumers have high disposable income and high expectations for food safety: Canada, the European Union (which oversees food safety in 27 member countries), Germany, Ireland, Japan, the Netherlands, and the United Kingdom. These six countries and the EU have, in the past decade, reorganized and streamlined their food safety regulatory structures either in response to public safety concerns or due to a desire for greater regulatory efficiency.

Key characteristics in many or all of the regulatory structures, as identified by the GAO, indicate the elements on which a unified U.S. food regulatory authority might focus:

Increased media reporting of food-related illnesses—with some sources claiming 70 million cases each year—followed by highly publicized product recalls has created the widespread perception that this multi-level system of food safety regulation is inadequate.

  • Farm-to-table oversight, in which the entire food production process is regulated, starting with how animals are raised on the farm and ending when food reaches the final consumer.
  • Separate authorities for risk assessment, the scientific evaluation of all known and potential adverse health effects resulting from foodborne hazards, and risk management, the process for weighing policy alternatives.
  • Risk-based inspection systems that focus on those foods and food products most likely to pose the greatest risk.
  • Meeting equivalent safety standards for certain foods and, in particular, food imports, most often involving meat or animal products.
  • Trace-back procedures in which all food and feed must be traceable “one step forward and one step back” so that industry and governments can quickly track any questionable food or feed products to minimize harm to public health and reduce the economic impact on industry. Food and feed business operators must be able to document the names and addresses of the supplier and customer, as well as the nature of the product and date of delivery.

Interestingly, although it did not explicitly say so, the GAO study found that two characteristics of the reorganized food safety structures are very much like the current, much-maligned U.S. system. First, the burden for food safety in most of the selected countries lies primarily with food producers rather than with inspectors, although inspectors play an active role in overseeing compliance. This principle applies to both domestic and imported products.

The U.S. system is, of course, quite similar, with frequent USDA inspections that generally reflect on-site working relationships, as well as FDA inspections that typically occur every five to seven years. Second, mandatory recall authority—the legal authority to remove, or require another party to remove, a product from the market—is rarely used in the countries studied. In the U.S., virtually all recalls are producer initiated: The only mandatory food recall authority is that of the FDA over infant formula and human tissue products, but the government can expand the scope of any voluntary company recall and can also encourage seizure of recalled products. State and local health authorities have broad, well-established powers as well.

Currently, even the minimum basis for deciding whether food safety is increasing or decreasing is lacking: namely, a useful database of foodborne illness that can track trends easily.

The Real Issue

So, did the GAO conclude that the “fewer food regulators, the better” in the locations they examined? In fact, the study reports that not one of the selected countries had conducted a comprehensive evaluation of its reorganized food safety system. Most track certain indicators, such as the number of inspections conducted, the number of enforcement actions taken, and the number of foodborne illness outbreaks, but go no further than that. And there is little, if any, hard evidence that the unified food regulatory structures led to a decrease in illness.

That, of course, is the real bottom line: Will a single food regulatory agency make food-related illness outbreaks less likely? Reorganizing food safety agencies is less important than adopting policies that prevent tainted food from entering the food supply and making people sick. Currently, even the minimum basis for deciding whether food safety is increasing or decreasing is lacking: namely, a useful database of foodborne illness that can track trends easily. Cases of illness are tracked in one fashion, “outbreaks” of foodborne illness in another way.

When foodborne illness rates go up—or down—in a particular category, regulators cannot easily determine whether the trend is caused by, say, globalization of food stocks; trends in public consumption like the rising consumption of fresh salads; distribution methods; processing (such as the prevalence of bagged salads); storage and refrigeration, whether at grocers or homes; farming issues like fertilizer or run-off at farms; or food handling and preparation. Building a single database would not be easy, but it could be done without reorganizing more than a dozen federal agencies. And without an adequate database, we will not be able to tell whether any reorganization achieves much in the way of food safety, especially considering the past success the FDA, USDA, and other agencies have had in making massive food safety advances. The knowledge base for evaluating broad policy changes is not there.

At a minimum, reorganization under a single authority likely means potential distraction and infighting among the component groups merged into the new single agency, and such an environment would not encourage efficient policy adoption. Simply recall the ongoing communication and efficiency problems in the Department of Homeland Security nearly a decade after its creation to visualize what could happen to the public health as a single food safety authority tries to get itself functioning. Moreover, without an upgraded foodborne illness database, we could not even tell whether reorganization or any broad policy change has succeeded.

Rather than establishing a new regulatory structure with no proven likelihood of food safety improvement, working to create a usable foodborne illness database—and continuing and expanding collaboration among the existing food regulatory agencies and the food industry to identify and rectify quality and safety concerns—offer the best means of reducing foodborne illnesses in the United States. ■

Hargan formerly served as deputy secretary and regulatory policy officer for the U.S. Department of Health and Human Services. He is currently a partner with McDermott Will & Emery; reach him at or (312) 984-0385.



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