Food safety regulation in the United States: an empirical and theoretical examination.

• Author: Yasuda, Tomohide
• Position: Essay

Consumers in the United States are frequently exposed to news about food poisoning outbreaks. The year 2009 started with a Salmonella outbreak caused by contaminated peanut paste (Blaney 2009). The year 2008 featured a Salmonella outbreak caused by peppers but initially blamed on tomatoes (Garber 2008b). The memory of three deaths in 2006 from spinach contaminated with the virulent O 157:H7 serotype of the bacterium Escherichia coli (E. coli) is still vivid (Levine 2007). Outbreak news is often accompanied by editorials that advocate larger budgets for food safety regulatory bodies (see, for example, Alliance for a Stronger FDA 2009). It is almost accepted wisdom that food safety regulation is indispensible and that the food safety authorities should do more to guarantee the safety of food sold on the U.S. market.

Before we expand any existing program, however, we need to examine whether that program is working as projected. The constant demand by the news media, politicians, and advocacy groups for greater funding for food safety agencies suggests that previous budget increases for these agencies have not produced the expected safety improvement. In this article, I first present the result of an empirical examination of the effectiveness of major food safety regulations in the United States, which shows that the effects of these regulations were not discernible in the food-borne-illness outbreak statistics collected by the Centers for Disease Control and Prevention (CDC). If government programs for food safety have not reduced food-borne illnesses, we need to doubt the accepted wisdom and ask the fundamental question: Is government intervention in the food market appropriate in the first place? I then examine the theoretical justification for food safety regulation and demonstrate that the theory is fundamentally flawed. I explain how the commonly used cost-benefit analysis rests on flawed methods and thus can always create the appearance of market failure and justify further government intervention in the food market.

Empirical Testing of Major Food Safety Regulations

The U.S. government maintains a complex patchwork of food safety bureaucracies that have multiplied over the past century. The activities these bureaucracies undertake may be divided into regulation of plant/factory sanitation, product inspection, restaurant inspection, consumer education, and compilation of disease outbreak statistics. These activities are shared by regulators at the federal, state, and local levels. In the federal government, fifteen agencies have legal mandates to provide food safety, with the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the CDC playing major roles (Walker 2007). The FDA and the USDA inspect domestic and imported food products as well as food-processing plants. The USDA inspects meat, poultry, eggs, and the processing plants for these products, and the FDA inspects the rest of foodstuffs and their plants (U.S. General Accounting Office [GAO] 1998, 2). Both federal and state agencies issue consumer advisories (Institute of Medicine 2007, 21-24). Restaurant inspection is usually carried out by local, county, or state health department personnel (Jones et al. 2004). The CDC compiles food-borne-disease outbreak statistics in cooperation with state governments, which also inspect food products and food-processing plants in their jurisdictions (Institute of Medicine 1991, 302-3).

The federal food safety mechanism has been criticized for its complex mandatory sharing and overlapping of activities among various agencies (see, for example, National Research Council 1998; Robinson 2005; "Import Alert" 2007; Trust for America's Health 2008). These criticisms, however, typically look at organizational arrangements, mandates, regulatory methodology, staff levels, and inspection efforts and do not examine whether the regulations are actually reducing food-borne illnesses. Their approach is analogous to evaluating the effect of policing on crime reduction by looking only at the levels of police activity. Here we look into the effect of regulatory activities on the food-borne-disease outbreak statistics collected by the CDC.

The CDC statistics include outbreaks but not isolated single cases, so they underestimate the true food-borne-disease burden in the United States. However, the CDC defines an outbreak as "the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food" (CDC 2000). This definition makes the statistics comprehensive enough to be "the basis for public health action" (CDC 2000). Moreover, outbreaks are what attracts media attention and galvanizes agencies into action. For example, after an E. coli O 157:H7-contaminated hamburger outbreak in 1993 that killed four children, both the FDA and the USDA introduced several new regulations (Golan et al. 2004, 10). In addition, a CDC estimate of the total food-borne-disease burden based on these outbreak statistics (Mead et al. 1999) has been widely cited as evidence of the significance of food-borne illnesses (see, for example, Golan et al. 2004, 2; Shute 2007). Furthermore, the FDA and the USDA use the CDC outbreak statistics when they estimate the benefits of proposed regulations (Williams and Zorn 1993; Crutchfield et al. 1997). Therefore, it is appropriate to use the CDC outbreak statistics to examine the effectiveness of food safety regulations.

Overall Performance of FDA and USDA Food Safety Activities

In the following subsections, I examine the performance of the four major food safety regulations: plant sanitary regulation, food-product inspection, restaurant inspection, and consumer education. Before going into these specific activities, I compare the recent budget increases given to the FDA and the USDA for their food safety activities and the U.S. food-borne-outbreak statistics collected by the CDC (figure 1).

Food safety budgets for the FDA have increased steadily over the past decade even as the numbers of outbreaks and cases caused by the foodstuffs for which the FDA is responsible (that is, all foodstuffs except meat, poultry, and eggs) fluctuated wildly (CDC 2000, 2006, 2008; FDA 2008b). No correlation is recognizable between the FDA budgets and the disease statistics. The food safety budgets for the USDA also increased, but the outbreaks and cases caused by meat, poultry, and eggs showed increasing trends with wild fluctuations (CDC 2000, 2006, 2008; USDA 2008a, 2008b). Other potentially relevant factors--such as the decline in the dollar's purchasing power, population growth, and food-consumption pattern shifts--were much less dramatic than changes in disease statistics, and they cannot explain the wild fluctuations in outbreak statistics. This analysis suggests a lack of a causal relationship between the recent FDA and USDA funding levels and the fluctuations in food-borne-disease statistics. One therefore must doubt the effectiveness of the FDA's and USDA's overall food safety regulations.

Sanitary Regulation of Food-Processing Plants

Both the FDA and the USDA have been promoting Hazard Analysis Critical Control Point (HACCP) as a major improvement to their century-old food safety programs (Crutchfield et al. 1997, 7; Kvenberg et al. 2000). HACCP requires food processors to identify potential sources of pathogen contamination and establish procedures to prevent contamination (Crutchfield et al. 1997, i). Mandatory HACCP requirements have been imposed on seafood (1997), meat and poultry (1997), and fruit and vegetable juice (2003) processors (FDA 1996, 2001b; Kvenberg et al. 2000). The FDA and the USDA carried out cost-benefit analyses of the HACCP requirements for these three categories of food processors before their implementation (Williams and Zorn 1993; Crutchfield et al. 1997; Anderson and Zorn 2003). These analyses projected great reductions in the numbers of disease cases in their benefit estimation. Figure 2 shows what happened to the CDC disease statistics after the implementation of these requirements and compares the agency projections plotted in the respective years of their implementation. Note that the scale for the reported actual cases (left column) is much smaller than that of the agency-estimated cases before and after the implementation (right column). When placed on the scale of the agency-estimated cases, the fluctuation ranges of the reported disease cases become unrecognizable (right column). Both the FDA and the USDA inflated reported statistics to compensate for unreported disease cases. (This practice of inflation raises a theoretical problem that I discuss later.) What is clear from figure 2 is that the agency projections do not match the wild fluctuations in the reported cases caused by these food categories. We cannot conclude from the reported cases that the HACCP requirements have reduced disease incidence.

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Mandatory milk pasteurization is a plant sanitary regulation that has attracted media attention lately because some people enthusiastically seek unpasteurized milk (Garber 2008a), which has been banned from interstate commerce since 1987 (Headrick et al. 1998). Twenty-two states ban the sale of unpasteurized milk, whereas the other twenty-eight states allow its sale within their territories ("What's Happening with Real Milk?" 2008). The question here is not whether pasteurization reduces pathogenic bacteria in milk, but whether banning the sale of unpasteurized milk reduces disease incidence when more than 99 percent of milk sold in the United States was already pasteurized in 1995 (Headrick et al. 1998) and some people eagerly consume unpasteurized milk. Thirteen outbreaks with 245 cases occurred in the twenty-two prohibition states in the five years from 2002 through 2006, whereas seventeen outbreaks with 248 cases were reported during the same period from the twenty-eight...