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Abstract & Commentary
The FDA and Food Safety Regulation
By Carol A. Kemper, MD, FACP, FIDSA, Clinical Associate Professor of Medicine, Stanford University, Division of Infectious Diseases; Santa Clara Valley Medical Center, Section Editor, Updates; is Associate Editor for Infectious Disease Alert.
Synopsis: Enactment of the Food Safety Modernization Act without funding for implementation places undue burden on smaller food producers and individually owned businesses.
Source: Osterholm MT. Foodborne Disease in 2011 The rest of the story. N Engl J Med 2011;364:889-891; Barton Behravesh C, Mody RK, Jungk J, et al. 2008 Outbreak of Salmonella Saintpaul infections associated with raw produce. N Engl J Med 2011;364:918-926.
Basically, people now feel nothing is safe to eat. They don't know what choices to make. They are really feeling very helpless." San Liwei, director of the Beijing office of the Global Food Safety Forum, on rising food safety concerns in China (New York Times Quotation of the Day; 05/09/11).
On Jan. 4, 2011, President Barack Obama signed into law a new Food Safety Modernization Act, which was the first major legislation since 1938 to increase the authority of the FDA to monitor and regulate food safety. The legislation is quite broad, and mandates the FDA to create firmer guidelines for monitoring food production and distribution, establish minimum standards for food safety, implement a modernized tracking system to trace food distribution in the United States, as well as on-site inspection of facilities, including access to all company records related to foods. It also allows the FDA to expand its monitoring of imported food products. The FDA now has the authority to order mass recalls and destruction of food should it not meet their current standards, as well as to charge penalties and fees for failed inspections, re-inspections, and mandatory recalls.
The effect of this legislation has already been felt from larger farms and corporations to small cheese making business not all of it good. For example, age old methods for air curing meats and the production of artisan cheeses do not necessarily meet current FDA standards. The loss of product and extraction of fees may mean bankruptcy for smaller food producers and individually owned businesses.
The problem: Congress failed to appropriate funds for implementation of the new law expanding the FDA responsibilities. Thus, extracting fees from businesses and farmers is the only way the FDA can support its expanded activities.
What is the evidence that such legislation is necessary or that its current implementation will be effective? Food-borne disease is surprisingly common in the United States, despite the apparent high quality of the food to which we have access. In 1999, the Centers for Disease Control and Prevention (CDC) estimated that food-borne illness caused 76 million episodes of illness (27% of all Americans), resulting in 325,000 hospitalizations (115/100,000) and 5,000 deaths (2/100,000). Current CDC estimates indicate a significant reduction in food-borne illness over the past decade (even before implementation of the current legislation), but they nonetheless remain a significant problem. Current estimates for 2011 indicate that 15% of Americans will develop food-borne illness, resulting in 128,000 hospitalizations (41/100,000) and 3,000 deaths (1/100,000).
Data collected by the FOODNET System, which provides active population-based surveillance of 10 states for all laboratory-confirmed infections for eight select pathogens also indicate that rates of food-borne illness over the past decade have improved. During the past decade, rates of infection with shigella, yersinia, Shiga-toxin-producing E. coli 0157, campylobacter, and listeria all fell by 25% or more, whereas Salmonella infections dropped about 10%. Only infections due to Vibrio spp. seem to have increased. While encouraging, Osterholm and colleagues point out that much of that improvement occurred early during the past decade, and no real improvement in rates of food-related infection for at least six pathogens has occurred from 2006 to 2009.
Some of these food-borne outbreaks were huge, such as the nationwide outbreak of Salmonella enterica serotype Saintpaul, which resulted in 1,500 documented infections in 48 states (21% affected were hospitalized and 2 died). A large-scale epidemiologic investigation found that infection was associated with eating raw tomatoes, eating in a Mexican restaurant, and eating salsa or raw jalapeno peppers. Eventually the infection was traced back to farms that supplied 13 restaurant clusters, and the investigation ended at two farms in particular, which were located only 100 miles apart in Mexico. Salmonella was found in the agricultural water of one of the farms, but was not the outbreak strain; the outbreak strain was eventually isolated from agricultural water and Serrano peppers grown on the second farm. Jalapeno peppers from an unknown source in a Texas grocery store were also positive for the outbreak strain, but could be traced no further.
This investigation was complicated by the complexity of the distribution system for produce, with commingling of products. Hence, the federal mandate to improve the tracking system for produce and other food stuffs makes sense, but will cost real dollars. However, when the cost of a large-scale investigation such as this is considered, let alone the real cost to human life and medical costs, the expense seems justifiable and necessary.
It is interesting that this large outbreak was eventually traced to produce grown outside the United States and where food production standards may differ and regulation may be lacking. This is an added reason that U.S. businesses and small individual farmers and producers should not be expected to shoulder the cost for implementation of better food tracking and safety standards.