The Food Safety System: Context and Current Status

The Food Safety System: Food safety is practically a scientific discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness.

Food safety is a scientific discipline which ultimately describes the handling, preparation, and storage of food in ways that prevent food-borne illness. The occurrence of two or more cases of a similar illnesses resulting from the ingestion of a common food is known as a food-borne disease outbreak.

Since the inception of food safety system and hygiene, lifes has been somewhat satisfactory to some extent.Humans began farming, agriculture has evolved rapidly, with pervasive effects on society. An example is the industrialization of food production in the twentieth century, which, among other things, dramatically changed perceptions and behaviors related to food (Hennessyet al., 2003).

While this revolution in food production resulted in great benefits to today’s consumers and the ability to feed a growing population, it also resulted in unanticipated foodborne risks. Regulatory agencies responsible for food safety thus are challenged not only to respond to current issues, but also to articulate a vision of food safety that anticipates future  risks.

This article sets the stage for the more detailed assessments, findings, and recommendations that follow by reviewing some of the developments that have contributed to the context for food safety in the United States and by providing an overview of the current U.S. food safety system.

A Changing world in Food Safety

Food safety is an important business. I guess am right? The Institute of Medicine (IOM)/National Research Council (NRC) report Ensuring Safe Food: From Production to Consumption (IOM/NRC, 1998) identifies a number of developments with implications for food safety, including (1) emerging pathogens, (2) the trend toward the consumption of more fresh produce, (3) the trend toward eating more meals away from home, and (4) changing demographics, with a greater proportion of the
population being immuno-compromised or otherwise at increase risk of food borne illness.

These developments continue to be important today, but many others affecting food safety have occurred in the decade since that report was published.

Together, these developments contribute to the current context for food safety in the United States, which is characterized by a number of features that must inform any assessment of the food safety system.

These include changes in the food production landscape, climate change, changing consumer perceptions and behaviors, globalization and increased food importation, the role of labor−management relations and workplace safety, heightened concern about bioterrorism, increased levels of pollution in the environment, and the signing of international trade agreements Changes in the Food Production Landscape.

In addition to constant changes in food production and substantial growth in the number of food facilities (the number regulated by the U.S.Food and Drug Administration [FDA] grew by 10 percent between 2003 and 2007 [GAO, 2008a]), the food and agriculture sector has experienced widespread integration and consolidation in recent years.

For example, the consolidation of supermarkets has changed the retail grocery landscape
in the United States, leading to the dominance of the industry by a small number of large companies. Apart from consequences for the market share of small retailers, the greater dependence of manufacturers on this limited number of retailers for sales volume gives  these companies significant leverage to bargain for lower prices and demand safety standards. The result has been an increased tendency to establish private standards, which has changed the enterprise of food safety (Henson and Humphrey, 2009).

Climate Change

Climate change is doubly relevant to the food enterprise: not only may climate change affect food yields, but food production may contribute to climate change by releasing a substantial amount of greenhouse gases, such as carbon monoxide and nitrogen monoxide (Stern, 2007). Stern (2007), among others, has highlighted serious concerns regarding the effects of climate change on future food security, especially for populations in low income
countries that are already at risk of food insecurity.

Climate change can affect food systems directly, by affecting crop production (e.g., because of changes in rainfall or warmer or cooler temperatures), or indirectly, by changing markets, food prices, and the supply chain infrastructure—although the relative importance of climate change for food security and safety is expected to differ among regions (Gregory
et al., 2005). A recent Food and Agriculture Organization paper, Climate Change:

Implications for Food Safety (FAO, 2008), identifies the potential impacts of anticipated changes in climate on food safety and its control at all stages of the food chain. The specific food safety issues cited are increased range and incidence of common bacterial foodborne diseases, zoonotic diseases, mycotoxin contamination, biotoxins in fishery products,
and environmental contaminants with significance for the food chain. To raise awareness and facilitate international cooperation, the paper also highlights the substantial uncertainty on the effects of climate change and the need for adequate attention to food safety to ensure effective management of the problem.

Changing Consumer Perceptions and Behaviors

With an increasingly global food market, consumer expectations and behaviors with regard to food have changed dramatically over the past hundred years. Consumers have grown to expect a wide variety of foods, including exotic and out-of-season foods. As a result, the consumption of fresh fruits and vegetables has increased (IOM/NRC, 1998) and is expected
to continue to do so: per capita fruit consumption is predicted to grow in the United States by 5−8 percent by 2020, with a smaller increase predicted for vegetables (Lin, 2004). Additionally, consumers are spending more money on food away from home, which accounted for 48.5 percent of total food dollars, or approximately $565 billion, in 2008 (ERS, 2010).

Globalization and Increased Food Importation

The expansion and liberalization of international trade in recent decades have resulted in an increase in food imports. By 2005, the volume of imported medical supplies and food had increased seven-fold over that in 1994, and this trend is expected to continue (Nucci et al., 2008). Among foods, the increase has been especially dramatic in the seafood sector, which the FDA oversees. From 1996 to 2006, the volume of FDA-regulated food imports
increased almost four-fold, from 2.8 billion to 10 billion pounds (Nucci et al., 2008). About 230,730 facilities that deal with imported foods are registered with the FDA, including foreign manufacturers, packers, holders, and warehouses (FDA, 2010a). Consequently, there is a growing need for a robust regulatory system that can ensure the safety of food imports.

This concern over the safety of imported foods is reflected in the number of congressional
hearings on the subject in 2007 and 2008 (GPO, 2010). Various countries are experimenting with models for regulating food imports (e.g., third-party certification, inspections at the border, country certifications), but there is no consensus on the best regulatory models. In this environment, the United States is attempting to determine the
best model to implement given available resources and the vast amount of imported foods to oversee.

For example, in 2007, at the request of the White House, the Interagency Working Group on Import Safety was established.

The Role of Labor−Management Relations and Workplace Safety

The crucial role of food employees and employers in food safety cannot be overstated, particularly since food workers have been implicated in the spread of foodborne illness (Todd et al., 2007). When addressing food safety, therefore, it is important to consider the potential role of labor−management relations and workplace conditions. For example, if
the labor force responsible for producing food on farms and in factories is inadequately trained or paid, is forced to work under unsafe or unsavory conditions, or is ignored by management when it attempts to express concerns, workers may respond by applying less care in the production, processing, or preparation of food, leading to increased risk for

Some elements of this association may be direct since many human pathogens are easily transmitted to foods via contact with human vehicles, and worker sanitation and hygiene are critical factors in this process.

Specifically, ensuring that workers have access to appropriate sanitary facilities, providing adequate sick leave, and making hand washing a critical control point are vital to controlling many hazards in the food supply.

Increased Levels of Pollution in the Environment

An undesirable consequence of the industrialization of agriculture and manufacturing is the release of chemicals to the environment. Not all food pollutants come from industrial processes, however. For example, dioxins and furans are contaminants released unintentionally into the environment as a result of both pre industrial combustion processes (e.g., the combustion of forests or brush) and modern combustion processes (e.g., industrial burning, landfill fires, structural fires) (IOM/NRC, 2003).

Whether exposure to these pollutants has increased over the years depends on the pollutant, and the data needed to assess trends are often lacking (IOM, 2007).

Limits on food safety

In examining how to improve a food safety system, one must acknowledge that foodborne illness cannot be completely eliminated. Many factors affect the degree of safety that is achievable, some related to the state of science and others to human factors, such as economic considerations and people’s desire to enjoy certain foods whose safety cannot be ensured (e.g., raw milk). The degree of food safety that is attainable also depends on
management and oversight practices, on costs versus benefits, and on such factors as regulatory limits, public perceptions, consumer education and responsibility, and public communication.

It is important to stress that responsibility for food safety falls on everyone, from farmers to consumers. However, the FDA is often held responsible for negative events related to food safety, given that ensuring food safety is part of the agency’s core mission. This focus on the FDA’s responsibilities has grown as such events have become more widespread,
garnering increased media attention.

Moreover, in recent years, reductions in the incidence of food borne illness seen in the late 1990s appear to have leveled off (CDC, 2009), and for some pathogens the incidence has
recently increased (CDC, 2010). Because many government agencies are responsible for food safety, it is not possible to attribute changes in the rate of food borne illness to any particular agency.

Still, the FDA’s responses to these events have sometimes been less than optimal (Produce Safety Project,2008).

Responsibilities of the Office of Foods

Provides executive leadership and management to all U.S. Food and Drug Administration (FDA) food-related programs.
• Exercises, on behalf of the Commissioner, direct line authority over the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM).
• Exercises, on behalf of the commissioner, all food-related legal authorities that the Commissioner is empowered to exercise under  the Federal Food, Drug, and Cosmetic Act, as amended; the Public Health Service Act; and other applicable laws.
• Directs efforts to integrate the programs of CFSAN, CVM, and the Office of Regulatory Affairs and thereby ensure the optimal use of all available FDA resources and tools to improve the safety, nutritional quality, and proper labeling of the food supply.
• Directs the development of integrated strategies, plans, policies, and budgets to build the FDA’s food-related scientific and regulatory capacities and programs, including recruitment and training of key personnel and development of information systems.
• Represents the FDA on food-related matters in dealings with the Office of the Secretary of the U.S. Department of Health and Human Services, the Centers for Disease Control and Prevention, the U.S. Department of Agriculture, the White House, and other elements of
the executive branch.
• Represents the FDA on food-related matters in dealings with Congress.
• Represents the FDA on food-related matters in dealings with foreign governments and international organizations.
• Directs FDA efforts to build an integrated national food safety system in collaboration with other federal agencies and state and local  governments.
• Directs a program of public outreach and communication on food safety, nutrition, and other food-related issues to advance the FDA’s public health and consumer protection goals.



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