Volume 43 | Number 3 Summer 2008
Food Safety Regulation in the European Union: Toward an Unavoidable Centralization of Regulatory Powers
Page 3 of 5
« First
<
1
2
3
4
5
>
Last »
4. Even Slightly Decentralized Systems Are Not Perfect: The Single Food Agency Debate in the United States
The issue of centralization of food regulatory powers has not only arisen in the EU. Other countries that have a more centralized system than the EU’s also see a push for even greater centralization. The United States, for example, has been facing calls for potential reform of its food agencies. Given the various food scares of the past decade, Americans have questioned the effectiveness of their current system.50 The issue is whether, instead of having two food agencies overseeing different aspects of food, there should be a single agency with the authority over all foodstuffs. This section demonstrates that, even with an already quite centralized system like that found in the United States, the question persists of whether to consolidate it even further.
i. Overview of the U.S. Food Regulatory System
The American food safety regulatory system is far more centralized than the European system. The issue of adulteration became a national issue in 1848 when Congress passed the Drug Importation Act, requiring inspection by the U.S. Customs Service to prevent the entry of adulterated drugs from abroad.51 In 1862, in order to address the issue of adulterated food, the Chemical Division of the United States Department of Agriculture (USDA) was established and then renamed the Bureau of Chemistry.52 This Bureau of Chemistry was the precursor to today’s Food and Drug Administration (FDA).53
After 1880, several food and drug bills were introduced to Congress, but it was not until 1906 that a major piece of legislation was passed. The Food and Drugs Act was enacted in June 1906 and prohibited interstate commerce of misbranded and adulterated foods, drinks, and drugs.54 This law was in part a reaction to Upton Sinclair’s book, The Jungle, which exposed unsanitary conditions in meatpacking plants.55 This book also led to the 1907 Federal Meat Inspection Act, which authorized meat inspections and the condemnation of meat products unfit for human consumption.56
In 1938, the Food and Drugs Act was preempted by the Federal Food, Drug, and Cosmetic Act (FDCA). This Act focuses on food misbranding and adulteration and serves as the basic framework for food regulation by the FDA and the USDA.57 This legislation created food standards, mandated inspections of factories, and provided for the issuance of court injunctions in addition to the already existing seizure and prosecution remedies.58 Since 1938, the FDCA has been amended a number of times and additional supporting laws have been enacted relating to food safety, security threats, and nutrition. Additionally, this federal framework is supplemented by state laws.
The USDA and the FDA are the main actors in food regulation in the United States. These two federal agencies encompass all phases of the food regulatory system: they evaluate, investigate, regulate, inspect, and sanction. The USDA oversees the safety of meat, poultry, and some egg products, while the FDA regulates all other foodstuffs, such as whole eggs, seafood, fruits, vegetables, grain products, and milk.59 As discussed previously, the European system differs: authority is not only divided among various countries, but those countries also have flexibility both in the way they control their food safety regulations and in the way they implement EU regulations and directives. This difference comes in part from the fact that the United States is a federal state and the EU is not. However, even in a centralized system like the United States, some argue that the USDA and the FDA should consolidate into one single food agency.60
ii. The Present U.S. System Does Not Prevent Food Scares
Despite a centralized regulatory scheme with a statutory mandate to regulate and enforce, food scares have not been eradicated within the United States. In September 2006, the FDA issued a warning against contaminated bagged spinach.61 Despite this warning, the E. coli bacteria caused the deaths of three people.62 Then, in February 2007, jars of peanut butter containing salmonella were recalled after almost three hundred people became ill.63 In March 2007, a massive recall of cat and dog food was issued, but not before thousands of pets suffered kidney failure, leaving at least sixteen of them dead.64 A month later, the problem had still not been solved.65
Given the already centralized nature of the American system, how can we expect that a decentralized system like the EU’s would work better? In other words, if such a centralized system does not work all the time, how can the EU’s completely decentralized system be efficient at all?
iii. The U.S.’s Single Food Agency Debate
The issue of whether the United States should combine FDA and USDA functions into a single food agency has been debated for several years.66 Both sides rely in part on arguments reflecting efficiency and practicality. The opponents of a single food safety agency argue that the agencies already have so many intrinsic problems that, if they were to merge, food safety risks would increase rather than decrease.67 They claim that consolidation would take too much time, would be very costly, and there would be regulatory gaps during the implementation period, thereby undermining the primary goal of safety.68 Furthermore, they point out that the FDA and the USDA have two different philosophies and each has its own expertise proper to specific areas of the food system.69 Moreover, they argue that since the food agencies already have to resort to the help of other agencies such as intelligence agencies and research organizations, creating a single food agency will not stop the need to work with other groups in a decentralized fashion.70
On the other hand, proponents of a single food agency argue that because different agencies are involved in food regulation and have different types of jurisdiction over different parts of the food supply, there are inconsistencies in the application of regulations.71 For example, when Food Safety Inspection Service inspectors (who work for the USDA) notice serious violations of USDA regulations, those inspectors can remove their inspection services immediately.72 This in turn forces the plant to stop operating, because foodstuffs under the USDA’s jurisdiction must have a USDA inspector present to inspect and approve the food products before they are sold to consumers.73 However, some products under the FDA’s jurisdiction are treated differently. For example, despite the fact that new food additives require prior FDA approval, cosmetics and dietary supplements can be marketed without it. The regulatory limbo starts when a food product contains a dietary supplement, such as orange juice with calcium—what happens then?74
Another argument for consideration is that the multiple jurisdictions create gaps, overlaps, and duplicative efforts, which in turn undermine the efficiency of both agencies.75 Proponents argue that having two agencies inspecting one facility is not efficient because those agencies supervise in different ways. A recent GAO report raises the issue that there are food-processing facilities which, due to the types of ingredients their products contain, are subject to both FDA and USDA regulations.76 Thus, in sandwich or canned soups facilities, for instance, USDA inspectors must inspect the soups or sandwiches containing meat or poultry while FDA inspectors inspect the other products.77 If the agencies ever issued recommendations that could not be reconciled, facility owners would find it very difficult to comply. Moreover, the overlap causes an inefficient use of funding and inspectors. With a single food agency, the standards would likely be more uniform, which would avoid the potential confusion caused by jurisdictional fragmentation.
Furthermore, proponents of consolidation argue that the dual regulation system creates rivalries between agencies and funding disparities that do not reflect food safety priorities.78 The funding received by the USDA and FDA is not proportionate to the amount of foodstuffs each agency regulates. In 2003, while the FDA oversaw seventy-nine percent of foodstuffs, it received forty percent of the budget spent on food safety oversight.79 In addition, the funding these agencies receive is “disproportionate to the percentage of food borne illnesses linked to the food products they regulate.”80 This inequality in funding encourages each agency to fight for turf and authority so that it can enhance its budget.81
Similarly, those in favor of centralizing food safety regulatory bodies in Europe claim that it would accelerate the inspection process, limit business uncertainties, and preserve consumer confidence.82 Just as the loss of consumer confidence in the EU forced changes in its regulatory system, the same thing is likely to take place in the U.S. if food scares continue. Having one agency in control of the whole food safety system would eliminate jurisdictional inefficiencies and inconsistencies, resulting in a more secure public and less burdensome regulations.
Over the years, the EU has realized that greater centralization would be necessary to eliminate barriers and promote free trade. But having also been through the food scares of the 1990s, the EU has realized that consistency is necessary for countries to safely trade foodstuffs. Accordingly, the EU adopted a more centralized risk assessment mechanism. The question is whether or not it will be effective.