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Microbiological Safety: The FDA's Role in Preventing Foodborne Illness

 

Microbiological Safety: The FDA's Role in Preventing Foodborne Illness

About the Human Foods Program

Introduction

The US food supply is one of the safest in the world, largely due to our emphasis on a proactive approach to food safety. The vision of the FDA Human Foods Program is that food is a source of wellness, and it is our mission to protect and promote the health of all people through scientifically driven methods to prevent foodborne illnesses, reduce diet-related chronic diseases, and ensure the safety of chemicals in food.

We support this mission by working to reduce the burden of pathogen-related foodborne illnesses. Using a risk management approach, enhanced by risk prioritization, we focus our efforts on the most critical areas to prevent or significantly reduce the incidence of foodborne illnesses from foods regulated by the FDA. Strong partnerships, scientific rigor, risk management through coordinated outbreak response, and a regulatory framework based on prevention are important contributors to preventing foodborne illness and part of our strategic approach to helping to ensure food safety.

Preventing foodborne illnesses is key to ensuring food safety. The Office of Microbiological Food Safety (OMFS) plays an essential role by utilizing information from past outbreaks as well as other data and information to develop targeted, risk-based approaches that help prevent contamination and address specific hazards before they lead to incidents.  Regular inspections and ongoing monitoring are important elements of the FDA's comprehensive food safety approach, complemented by proactive measures and collaboration with stakeholders across the food supply chain. This proactive approach emphasizes health and wellness, aiming to safeguard the food supply and prevent issues before they occur.

Partnerships

The FDA advances food safety through a robust framework of partnerships at the local, national, and international level. Domestically, the agency collaborates with state, local, tribal, and territorial regulators, federal agencies such as the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), Centers for Disease Control and Prevention (CDC), and academic institutions to streamline inspections, coordinate rapid responses to foodborne illnesses, and advance food safety research and education. These efforts are supported by partnerships through initiatives like the Partnership for Food Protection (PFP), The Retail Food Safety Collaborative and Domestic Mutual Reliance, which integrate food safety efforts across various jurisdictions. The FDA also engages with the food industry, state, and international partners to promote compliance with the Food Safety Modernization Act (FSMA) regulations. As part of the FDA’s Strategy for the Safety of Imported Foods, the FDA actively works with international regulatory bodies and health organizations to align safety standards to ensure that imported foods meet the same safety standards as those produced domestically. Additionally, the agency participates in various international forums such us the Food Safety Partnership and CODEX to foster relations and alignment with our regulatory counterparts worldwide. This comprehensive approach allows the FDA to manage the complexities of global food supply chains and uphold food safety standards both at home and abroad.

Research and Advancements

Ongoing research is vital in closing knowledge gaps and enhancing the FDA's ability to prevent foodborne illnesses. The agency invests heavily in microbiological, genomic, toxicological, and chemical studies, paving the way for innovations in food safety. Techniques such as whole genome sequencing (WGS) and predictive analytics are at the forefront of these advancements, offering the ability to track pathogen evolution and predict potential outbreaks. Additionally, the FDA also works collaboratively with research institutions, industry, federal, state and local partners to better understand and find solutions for complex food safety issues. A key example of this collaborative research is ongoing Environmental Studies which aim to better understand and prevent routes of contamination in produce growing areas. Additionally, the FDA’s human foods program supports four University Centers of Excellence which provide research and capacity building that address timely cutting-edge issues related to food safety.

Outbreak Response

Despite rigorous prevention efforts, outbreaks can still occur. The FDA’s response effort is spearheaded by the Coordinated Outbreak Response and Evaluation (CORE) Network, which integrates expertise from various disciplines to manage and mitigate the impact of foodborne diseases rapidly. The FDA's CORE Network employs a comprehensive approach that includes surveillance, response, and post-response evaluations. Working in collaboration with various agencies including the CDC, the CORE Network actively monitors and responds to emerging outbreaks by evaluating disease surveillance trends and analyzing data from past inspections and sampling results. This integrated response system enables the FDA to manage incidents related to FDA-regulated food products swiftly and effectively, employing a science-based approach to stop outbreaks and implement preventive measures.

As part of its response efforts, FDA issues public advisories and conducts detailed inspections as part of the outbreak investigations. This helps control and stop outbreaks, address immediate public health threats and enhance long-term food safety. Through improvements in detection and prevention, such as the development of advanced testing methods (e.g., whole genome sequencing) and advancing root cause analysis, the FDA continues to strengthen its food safety framework, ensuring robust protection for consumers.

Regulatory Framework

The regulatory landscape for food safety is founded on the Federal Food, Drug, and Cosmetic Act (FD&C Act), which was significantly enhanced by the FDA Food Safety Modernization Act (FSMA).  FSMA regulations provide the foundation for a proactive approach to food safety.  As the first major reform of the food safety system in 70 years, FSMA represents an important shift in focus – from reaction to prevention, introducing requirements that affect every aspect of the food production and distribution chain. Compliance with these regulations is critical, as they are designed not only to manage but also to prevent foodborne illnesses through a comprehensive legal framework that is designed to keep evolving as new challenges emerge.

The FDA’s integrated approach toward prevention through research, partnerships, and risk management exemplifies a dynamic and robust defense against foodborne illnesses. Continuous evaluation and adaptation of approaches based on scientific research and outbreak investigations help refine these efforts, ensuring the U.S. food supply remains among the safest globally.

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