Introduction and Background
2018 FSMA Annual Report
This report describes the fiscal year (FY) 2018 activities of the Food Safety Modernization Act Surveillance Working Group (FSMA-SWG) of the Board of Scientific Counselors, Office of Infectious Diseases (BSC/OID), a federal advisory committee at the Centers for Disease Control and Prevention (CDC). This Working Group was established in FY 2012 under authorization by the Food Safety Modernization Act of 2010 (FSMA). Membership comprises 21 experts representing local, state, and federal governments; academia; industry; and consumer groups (Appendix 1).
During FY 2018, the Working Group reviewed activities, responded to specific questions, and provided guidance on how foodborne illness surveillance could be improved by measuring the public health impact of FSMA regulations and addressing the challenges of the increasing use of culture-independent diagnostic tests (CIDTs). The Working Group also reviewed, discussed, and provided guidance on several other CDC FSMA-related projects to enhance foodborne surveillance. For reference, previous topics covered by the Working Group are summarized in Appendix 2.
Each year, an estimated 48 million people in the United States (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die from (largely) preventable foodborne diseases. 1,2
Foodborne illness is costly. According to a 2015 study, 3 15 pathogens alone are estimated to cost $15.5 billion in the United States per year. This includes medical costs (doctor visits and hospitalizations) and productivity loss due to illness and time lost from work as well as premature death. Globally, the World Health Organization (WHO) estimated that each year as many as 600 million, or almost 1 in 10 people in the world, fall ill after consuming contaminated food. Of these, an estimated 420,000 people die, including 125,000 children under the age of 5 years. 4
Public health surveillance is necessary for improving food safety. Timely detection and control of foodborne disease cases and outbreaks can directly reduce their public health impact; identify new food safety hazards; and enable investigators, regulators, and the food industry to learn more about ways to prevent these diseases.
Foodborne illnesses and outbreaks are reported and investigated at the local and state levels. These investigations help identify and prevent foodborne illness in local/state jurisdictions and provide essential information for national public health and food safety systems. CDC compiles information from local and state agencies and works with them to identify and link outbreak-associated illnesses, leading to identification of contaminated foods and management and control of outbreaks. Outbreak data are collected, analyzed, and shared with many stakeholders. Data from these outbreaks serve as a foundation for action by CDC, regulatory agencies, the food-producing industry, and others interested in improving food safety.
Foodborne disease and outbreak surveillance data aggregated by CDC are essential for many functions, including informing evidence-based policies, effectively assessing public health risk, and developing prevention messages for food safety improvements. These data are relied upon by other government regulatory agencies and analyzed by the media, public health, and consumer organizations that provide food safety advice to consumers and policymakers. In January 2013, CDC released the first comprehensive set of estimates of the food categories responsible for foodborne illnesses acquired in the United States from 1998–2008. 5 Building on the 2011 estimates, which showed that about 48 million people (1 in 6) get sick each year from food, these newer estimates along with annual foodborne illness trend data from the Foodborne Diseases Active Surveillance Network (FoodNet) help regulators and industry identify the groups of foods most responsible for foodborne illness. These data also provide a historical baseline of estimates that can be further refined over time as more data and improved analytic methods become available.
Over the years, differences in data collection and reporting among states, along with issues regarding integration among various government agencies, have led to calls for improvements to ensure that foodborne illness surveillance systems provide the necessary data to assist government agencies, industry, and other food safety stakeholders in their risk-management activities.
CDC and FSMA
The Food Safety Modernization Act of 2010 provided the U.S. Food and Drug Administration (FDA) with new enforcement authority designed to achieve higher rates of compliance with prevention and risk-based food safety standards to better prevent contamination events as well as respond to and contain problems when they occur. Additionally, the law directed FDA to build an integrated national food safety system in partnership with state and local authorities. Recognizing the critical role of foodborne illness surveillance data in informing prevention efforts and CDC’s expertise in this area, FSMA also directed CDC to improve governmental coordination and integration, evaluate and improve foodborne illness surveillance systems, and enhance external stakeholder collaboration.
Signed into law on January 4, 2011, FSMA authorized CDC to create a diverse working group of experts and stakeholders to provide routine and ongoing guidance to improve foodborne illness surveillance systems in the United States and to provide advice on the criteria for the designation of five Integrated Food Safety Centers of Excellence (CoEs). In response, the FSMA-SWG of CDC’s BSC/OID was created, with BSC/OID member Dr. James Hadler of Yale University’s School of Public Health serving as Chair from November 2011 through December 2013; BSC/OID member Dr. Harry Chen, former Commissioner of the Vermont Department of Health, serving as Chair from January 2014 to November 2017; and BSC/OID member Dr. Timothy Jones, State Epidemiologist of the Tennessee Department of Health, serving as Chair from December 2017 to the present.
According to FSMA legislation regarding improvement of foodborne illness surveillance systems, areas for working group discussion and provision of guidance are:
- “The priority needs of regulatory agencies, the food industry, and consumers for information and analysis on foodborne illness and its causes;
- Opportunities to improve the effectiveness of initiatives at the Federal, State, and local levels, including coordination and integration of activities among Federal agencies, and between the Federal, State, and local levels of government;
- Improvement in the timeliness and depth of access by regulatory and health agencies, the food industry, academic researchers, and consumers to foodborne illness aggregated, de-identified surveillance data collected by government agencies at all levels, including data compiled by the Centers for Disease Control and Prevention;
- Key barriers at Federal, State, and local levels to improving foodborne illness surveillance and the utility of such surveillance for preventing foodborne illness;
- The capabilities needed for establishing automatic electronic searches of surveillance data; and
- Specific actions to reduce barriers to improvement, implement the Working Group’s recommendations, and achieve the purposes of this section, with measurable objectives and timelines, and identification of resource and staffing needs.”
This annual report to the Secretary, Department of Health and Human Services, (required by FSMA) highlights the FSMA-SWG’s activities and recommendations in FY 2018 and summarizes priority areas for focus in the coming year.