William F. Balistreri, MD


February 08, 2016

In This Article

Implementing Change

The FSMA, a long-awaited major overhaul of food safety laws, will hopefully be implemented soon; it is pending funding authorization by Congress. It is estimated that the FDA will need $260 million to fully implement and enforce the seven major food safety rules, but appropriations bills in both the House and Senate apparently allocated less than the needed total for fiscal year 2016. Since the legislation did not include adequate resources to cover the costs of the new requirements, Congress must work to ensure that the FDA has sufficient funds to achieve the food safety and food defense goals.[22,23]

Once the FSMA mandates are fully in force, the FDA will have more effective enforcement tools for ensuring that its directives are properly implemented, including mandatory recall authority when needed to swiftly remove contaminated food from the market.

A strategy is also needed to determine how produce growers can verify their compliance with FSMA, raising questions as to how to effectively monitor for chemical, biological, and physical contaminants; how to report who is responsible; and how much regulation is too much.

Recognition and Reporting Are Key Components

Rapidly determining common food exposures among patients, often in distant localities, is crucial. However, patients sometimes have difficulty remembering the foods they have eaten and when and where they purchased these foods. Therefore, collaboration with retailers to use data from shopper loyalty cards and store membership programs to obtain specific purchase date and brand information on products that consumers purchased before their illness will aid in future investigations.[31,32]

Three federal agencies—the CDC, the FDA, and the USDA-FSIS—have teamed up to create the Interagency Food Safety Analytics Collaboration (IFSAC). The goal of this collaboration is to improve coordination of federal food safety analytic efforts and to address cross-cutting priorities for food safety data collection, analysis, and use.[33] This includes foodborne illness source attribution, defined as the process of estimating the most common food sources responsible for specific foodborne illnesses.

Improved Diagnostic Approaches

Historically, microscopy, antigen tests, culture, real-time PCR, and enzyme immunoassay are the methods most commonly used by clinical laboratories to detect enteric bacterial pathogens such as Salmonella, Shigella, Campylobacter, and Shiga-like toxin. Recently, several multiplex molecular assays have been developed for the detection of these gastrointestinal pathogens directly from clinical samples. These panels allow for the identification of up to 20 pathogens in as little as 1 hour. In contrast, routine diagnostic culture methods typically require 48-72 hours for incubation and rule-out testing.

Many centers, including ours, have evaluated a multiplex nucleic acid amplification assay for detection of enteric pathogens in stool specimens. The methodology showed superior sensitivity compared with conventional methods and excellent specificity.

Binnicker[34] has reviewed the multiplex molecular panels that have received clearance from the FDA for the diagnosis of diarrheal disease, highlighting issues related to test performance, result interpretation, and cost-effectiveness of these new molecular diagnostic tools.

Reporting and Monitoring

Tracking and reporting outbreak information are critical to understanding how foodborne illnesses affect America's health.

There are several tools available for this purpose:

CDC online tool for foodborne outbreaks. The CDC created the Foodborne Outbreak Online Database (FOOD Tool) using its Foodborne Disease Outbreak Surveillance System.[35] During an outbreak, public health investigators can use the database to help point them toward possible contaminated food sources by searching foods and the pathogens implicated in past outbreaks.

National Outbreak Reporting System (NORS). A voluntary national online data entry reporting system,[36] NORS supports reporting of all foodborne disease outbreaks and all outbreaks of acute gastroenteritis resulting from transmission by contact with contaminated environmental sources.

Foodborne Diseases Active Surveillance Network (FoodNet). FoodNet provides a foundation for food safety policy and illness prevention efforts in the United States by estimating the number of foodborne illnesses, monitoring trends of specific foodborne illnesses, conducting studies to understand the causes of these illnesses, and informing the public about its findings.[37] FoodNet conducts active, population-based surveillance at 10 US sites for laboratory-confirmed infections of nine bacterial and parasitic pathogens transmitted commonly through food. In 2014, FoodNet identified more than 19,500 infections, over 4400 hospitalizations, and 71 deaths among residents of 10 states (15% of the US population).[10,37]

The Bottom Line

There are clear short- and long-term consequences of enteric infections acquired while ingesting pathogen-contaminated food. However, these are largely preventable.

Enhanced awareness and individual accountability, newly implemented regulations and performance standards, and adherence to industry-developed best practices will collectively improve food safety. However, all of these efforts do not guarantee that food products will be fully contaminant and pathogen free.

We are all stakeholders in this ongoing quest to diligently prevent needless and even fatal infections acquired during the death-defying act of eating lunch!


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