Executive Summary

Foodborne illness sickens or kills an extraordinary number of people each year. It also has great economic costs. Last year, an outbreak linked to contaminated cantaloupe in the United States sickened 146 and killed 30. In 2011, another outbreak in Germany that was eventually linked to contaminated sprouts, sickened more than 4,000 and caused at least 50 deaths. Foodborne disease outbreak response is a critical part of reducing the consequences of outbreaks that will occur in the future. If public health officials can more quickly recognize when a foodborne illness outbreak has occurred and identify the food causing the outbreak, lives can be saved and economic losses averted. The lessons learned from outbreak investigations can be used by industry and government to address the underlying causes of contamination that lead to illness, thus making food safer for everyone.

The Center for Biosecurity of UPMC produced this report to catalyze improvements in the country's ability to respond to large foodborne disease outbreaks. We analyzed the existing data and studies on foodborne illness outbreak response, identified emerging trends, and interviewed dozens of federal and state level officials and experts from industry, professional organizations, academia, and relevant international organizations. The report puts forth a series of recommendations to accelerate and strengthen responses to foodborne illness outbreaks in the US.

Findings

1. Foodborne illness outbreaks continue to impose enormous health and economic burdens in the US.

Foodborne diseases cause significant morbidity and mortality in the US, sickening more than 40 million people and causing 128,000 hospitalizations and 3,000 deaths each year.1 Medical expenses combined with lost productivity from foodborne illness cost upwards of $77 billion annually.2 Compared to the significant health and economic tolls associated with foodborne illnesses, the level of resources devoted to preventing and responding to such outbreaks is quite small.

2. Effective surveillance for and rapid response to foodborne illness outbreaks are critical to overall preparedness.

In addition to helping to mitigate the consequences of accidental contamination of the food supply, effective surveillance and rapid response to foodborne disease outbreaks can help improve overall readiness for other public health emergencies. The same surveillance systems and public health investigation approaches used to conduct routine outbreak investigations will likely be the country's first response to deliberate contamination of the food supply. Therefore, maintaining state and local health departments' capacity to respond is a necessary component of preparedness for biological attacks.3

3. National surveillance programs have led to meaningful improvements in the detection of foodborne illness outbreaks and can drive improvements in food safety.

Foodborne disease surveillance programs such as the US Centers for Disease Control and Prevention's (CDC's) PulseNet, FoodCORE, and FoodNet have helped to improve response to foodborne illness outbreaks and food safety in general. Improved surveillance has led to the detection of many more foodborne illness outbreaks, including some that have involved just a handful of cases spread out among several states. Investigations in the past decade have resulted in the recall of hundreds of millions of pounds of contaminated products. More importantly, information obtained from outbreak investigations allows identification of previously unrecognized problems in the food supply, giving industry and regulators the information they need to implement changes to ensure safer food products.

4. Determining the source of foodborne illness outbreaks remains the top response challenge and will likely become harder as the complexity of the food supply increases.

Linking a known case of gastrointestinal illness to the ingestion of a specific contaminated food product continues to be a major challenge in responding to foodborne illness outbreaks. In nearly all outbreaks, public health agencies rely on interviews of individual case patients to determine what foods they may have consumed around the estimated date of infection. Food histories are typically incomplete and insufficient to identify the source in time to make a difference. In addition, the complexity of the food system makes tracking down a single contaminated ingredient difficult.

5. Heterogeneity in states' capacities to detect and respond to outbreaks creates national vulnerabilities.

Local, regional, and state health departments have differing capabilities, budget priorities, and procedures. There is also a wide range in the speed and frequency with which states initiate foodborne illness outbreak investigations. States that are considered leaders in the field of foodborne illness outbreak response consistently commit to 3 response components: (1) they rapidly interview all patients reported to the health department as having been infected with a pathogen that is commonly associated with foodborne disease; (2) they pay for a courier services to transport specimens from clinical labs to public health laboratories for faster testing and analysis; and (3) they conduct strain-typing tests on all tracked organisms in the recommended time frame.

6. The increased adoption of culture-independent diagnostic testing by the clinical sector threatens to undermine early detection of foodborne illness outbreaks.

In recent years the advent of laboratory-based surveillance programs has greatly improved the speed and frequency with which foodborne illness outbreaks are detected in the US, but there are serious concerns about the viability of current surveillance approaches. This is because changing trends in clinical medicine have led to increased use of diagnostic tests that do not require isolation and culturing of pathogens. This change is causing a decline in the availability of clinical isolates on which PulseNet and other public health surveillance programs depend. Without clinical isolates, PulseNet will not function, and without PulseNet, our foodborne illness response efforts would be seriously degraded.

7. Tapping nontraditional data sources may help improve detection and response to outbreaks.

Persistent challenges in determining the source of foodborne illness outbreaks have prompted interest in new sources of data to aid in outbreak investigations. The most commonly cited example of this is health departments' growing use of data contained in shoppers' club cards. Other valuable nontraditional data may come from analysis of food distribution pathways, food consumption and marketing surveys, coordination with industry, and crowd-sourced information.

8. Better integration of existing surveillance programs is necessary to improve outbreak detection and response.

Improved access to existing foodborne illness outbreak information, such as that which exists at the CDC, the US Food and Drug Administration (FDA), and the US Department of Agriculture (USDA), is necessary to improve the speed and accuracy with which foodborne illness outbreaks are detected and their sources identified. Several high-profile outbreaks have led to a dedicated effort to improve communication and information sharing at the national level, but more integration of these systems is needed.

9. Federal funding cuts are expected to compromise the public health system's ability to respond to foodborne illness outbreaks.

Since 2005, there has been a net decline in the amount of federal funding available to support public health preparedness, while at the same time, state governments have drastically reduced their investments in public health.4 As a result, the capacity of state and local public health agencies to investigate and respond to foodborne illness outbreaks has been reduced. Federal support was cited as critical to enabling state and local practitioners to investigate foodborne illness outbreaks and identify leads. The consequence of planned cuts to state and local public health preparedness programs and of reduced funding for the key foodborne illness outbreak response systems we rely on across the country will be slower recognition of major foodborne disease outbreaks and the delayed ability - or even inability - to identify the contaminated foods that are responsible. Such an outcome threatens to exacerbate the economic consequences of the loss of consumer confidence in the food supply and to increase unnecessary severe illness and loss of life from foodborne illness.

10. The Food Safety Modernization Act has the potential to significantly improve the safety of the US food supply, but it will likely do little to improve public health response to foodborne illness outbreaks.

The Food Safety Modernization Act (FSMA) seeks to improve the safety of food produced or consumed in the United States by enhancing measures to prevent or detect food contamination closer to the source of production.5 If fully implemented and funded, FSMA will likely reduce the consumption of contaminated food, which should reduce the number of outbreaks. Congress should be commended for passing this food safety legislation,6 but there is still a need to strengthen systems for detecting and responding to foodborne illness outbreaks. First, implementation of FSMA has been slowed by delays in the rulemaking process and by lack of funding. Second, even if fully implemented, it is not likely that FSMA will protect the food supply sufficiently to reduce the need for robust outbreak surveillance and response systems. Third, although the law contains some requirements for improving foodborne disease outbreak surveillance and response capacity at local, state, and federal levels, efforts on this front to date have been small and insufficient compared with what is needed. As a first priority, FSMA should be fully implemented and funded, including critical provisions to improve public health capacity, but measures beyond FSMA are also needed to address detection and response vulnerabilities highlighted elsewhere in this report.

Recommendations

1. The US government should fund the development of next-generation technologies that provide rapid diagnosis while preserving the capacity to identify and resolve large outbreaks.

Existing foodborne illness outbreak surveillance programs depend on testing pathogens that are isolated from cultures of clinical specimens. Increased use of diagnostic approaches that do not rely on culture-based approaches is reducing the number of isolates submitted to public health laboratories. Although a number of administrative patches to this problem have been suggested - for example, requiring that clinical laboratories perform additional culture-based testing on positive samples - many of these options are probably not feasible in the long term given efforts to reduce healthcare costs. A new technological solution is needed.

2. Congress should restore funding to state health departments.

Cuts to federal funding and declines in state budgets threaten to reverse critical improvements in detection and response to multistate foodborne illness outbreaks and to national preparedness for other public health emergencies. Increases in the complexity of the food system will require more, not less, intensive public health investigations. This will not happen with the coming budget reductions. To prevent the further erosion of the gains made since 2001, the US should restore funding for these programs to at least 2005 levels. This is a small but important investment relative to the substantial health and economic losses caused by foodborne illness outbreaks. Even small increases in funding for health departments for these programs (<$1 million per state) could substantially increase the country's ability to respond to and resolve large foodborne illness outbreaks.

3. The US should develop a foodborne illness outbreak response network that taps the expertise and data that exist in the private sector.

The increasing complexity of food production and distribution requires greater information exchange among public health and industry officials during outbreaks than ever before to improve the speed and accuracy with which causes of outbreaks are identified. Most public health agencies rely on federal agencies as their primary liaison with the private sector, but the resulting information is often insufficient for investigation and containment of foodborne illness outbreaks. State and local public health agencies need direct connections to the private sector.

4. Congress should adequately fund and agencies should fully implement FSMA, including provisions for strengthening surveillance and response to outbreaks.

Congress should adequately fund FSMA, and agencies should work quickly to fully implement this act. Although FDA and CDC have made significant progress in implementing FSMA provisions relating to outbreak response, full implementation has been unnecessarily slowed by funding shortages and belated rulemaking, leading to substantial delays. Congress should appropriate funds to meet FSMA's objectives to enhance disease surveillance by increasing coordination among local, state, and federal disease surveillance systems as well as by developing and implementing strategies for enhancing capacities at the state and local levels.

5. The US government should improve integration of existing foodborne illness surveillance efforts.

A first priority for improving surveillance for foodborne illness outbreaks should be to improve the integration of the food-related surveillance initiatives that exist across the federal government. There are many different, separate national surveillance systems that, if integrated, could provide a better understanding of the occurrence and possible causes of foodborne illness outbreaks. Federal agencies should digitally connect and automate the comparisons of data from the food, animal, and human health surveillance programs that are operated by CDC, FDA, and USDA, which may provide an earlier indication of a link between human and animal infections. At the very least, there should be a way to directly compare isolate patterns that are in animal and human health surveillance programs. CDC's PulseNet and USDA's VetNet programs should be linked and equipped to automate analysis of these 2 data streams for evidence of similarities that may indicate a common exposure.

The US government should also continue to work to improve public health officials' access to data from healthcare providers, which would expedite their response to foodborne illness outbreaks. In many places, reporting of foodborne diseases from the clinical sector continues to be incomplete or delayed. As the nation builds a national framework for electronic health records (EHRs), there is a great opportunity to develop critical connections between public health and healthcare to enable earlier detection of cases of gastrointestinal illness that may have been caused by consumption of contaminated food. In particular, EHR development efforts should focus on expediting disease reporting by clinical laboratories to public health agencies.