The legislation is intended to address the continuing deaths and illnesses suffered by Americans each year as the result of fresh and processed foods tainted with a variety of pathogens such as shigella, yersinia, Shiga-toxin–producing Escherichia coli (STEC) O157, campylobacter, and listeria and salmonella. However, public health experts question the effectiveness of the new law as well as other government efforts to significantly reduce the risk of food poisoning.
The CDC currently estimates that there are approximately 48 million food borne illnesses, 128,000 hospitalizations, and 3000 deaths per year in the United States. That means that 15% of Americans can expect to have a food borne illness annually and that 41 in 100,000 will be hospitalized and 1 in 100,000 will die. This represents an improvement over prior figures collected during the 1990’s, probably as the result of changes in food safety monitoring initiated in the late 1990’s. But, according to Michael T. Osterholm, Ph.D., M.P.H. of the Center for Infectious Disease Research and Policy at the University of Minnesota, “we’ve made little additional progress in the past decade.” Writing in the February 23, 2011 issue of The New England Journal of Medicine, Osterholm notes that “although the media and some food producers, processors, wholesalers, and retailers may conclude that the recent CDC estimates offer evidence of major improvements in food safety since 1999, data from active population-based surveillance offer a more nuanced and neutral picture.”
In particular, outbreaks of food poisoning attributed to raw produce, such as jalapeño peppers, have only recently been appreciate as major vectors for the spread of food borne illness, and, according to Dr. Osterholm, “are among the most difficult ones for public health officials to identify and control, since produce from a single farm may be distributed widely and consumed rapidly because it is perishable.”
The new federal law, known as the Food Safety Modernization Act, gives the FDA broader authority to regulate food facilities, including authorization to inspect records related to food. It “requires each owner, operator, or agent in charge of a [nonexempt] food facility to identify and implement preventive controls to significantly minimize or prevent hazards that could affect food manufactured, processed, packed, or held by [that] facility.” It also requires the FDA “to issue guidance documents to reduce the risk from the most significant food borne contaminants” and to “establish minimum standards for the safe production and harvesting of fruits and vegetables based on known safety risks.” It further requires the FDA “to allocate resources to inspect facilities and imported food according to the known safety risks of the facilities or food; and [to] establish a product tracing system to track and trace food that is in the United States or offered for import into the United States.” It gives the FDA authority to order a recall of a food when it is contaminated or implicated in an outbreak. Finally, it “requires U.S. importers to perform risk-based foreign supplier verification activities to verify that imported food is produced in compliance with applicable requirements related to hazard analysis and standards for produce safety and is not adulterated or misbranded.”
Unfortunately, the new law so far lacks the funding necessary to implement its major provisions. There was no appropriation approved by the Congress for the act or authorization in the bill for the FDA to assess fees on the companies that it inspects. The Congressional Budget Office estimated that implementing this legislation would require $1.4 billion between 2011 and 2015. Though the bill authorizes the FDA to collect fees when a facility requires reinspection and a recall fee for mandatory recalls, these fees are expected to provide minimal resources. According to Dr. Osterholm, “the actual effect of this important law will at best be extremely limited if Congress and the administration don’t appropriate and sign additional legislation providing the necessary funds to carry out its mandates.” Without proper funding, “food safety in the United States cannot be expected to improve in more than an incremental manner.”
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