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Overview of the Human Foods Program (HFP) Operating Model

About the Human Foods Program

Human Food Program (HFP) FY 2025 Priority Deliverables

Summary

The concept map below depicts how we envision the components of the Human Foods Program (HFP) operating, including the foods activities of the Office of Inspections & Investigations (OII). The HFP is designed to facilitate a consistent, systematic, and intentional risk management approach to our regulatory responsibilities that will enable us to meet our mission to protect and promote the health and wellness of all people through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure that chemicals in food are safe to achieve our vision of the food supply as a vehicle for wellness. Through this approach, we will identify, assess, and prioritize the public health risks that the program is charged with managing, align our resources accordingly, and evaluate the effectiveness of our actions. 

The concept map depicts how the components of the HFP, including the foods activities of the Office of Inspections & Investigations (OII), are envisioned to operate.

Risk Pillars

To achieve our mission and vision, we consider emerging and known risks within the context of three risk management pillars: (1) microbiological food safety, (2) nutrition, and (3) food chemical safety, dietary supplements, and innovation. These pillars encompass the areas of highest risk and opportunity for our food supply and public health, and where the HFP can have the greatest impact within the scope of our mandates, functions, and resources. 

Signals & Surveillance Strategy

To begin, we use a surveillance strategy to define our approach to collecting and generating the data needed to understand the state of the food supply and the impact of our risk management efforts on it. Signals and surveillance activities include adverse event reports, sampling, inspection findings, complaints, research data, and data from external partners. The data from our surveillance strategy helps us identify new or potential risks.

Risk Prioritization

Once identified, emerging risks are assessed, ranked, and prioritized according to their public health impacts, along with other known risks in each pillar. We then develop risk management strategies to address these risks. As with all parts of the operating model, this process requires effective collaboration and coordination across functions with recognition of all equities and consideration of additional factors, such as other regulatory responsibilities, resource constraints, long-term strategic goals, evaluation results, Congressional mandates, and court deadlines. 

HFP leadership ultimately prioritizes the program’s limited resources to best address risks for each of the pillars’ areas of public health focus. These priorities, along with other regulatory responsibilities, are then further detailed at the office level through the office workplan process. 

Risk Management Actions

Based on these decisions, HFP and OII staff carry out risk management actions. These actions include: 

  • Policy and standard setting activities, such as rulemaking, guidance, administrative actions, and coordination with international standard setting bodies (e.g., Codex)
  • Premarket and post-market safety reviews 
  • Communications and education, including stakeholder engagement
  • Partnerships with regulatory agencies and other stakeholders to advance an Integrated Food Safety System
  • Inspections, investigations, and import oversight
  • Regulatory research and testing
  • Compliance and enforcement actions
  • Preparedness and response.

Information obtained from these actions flows back into ongoing signals and surveillance activities, as defined by the overarching surveillance strategy.   

Monitor Progress & Evaluate Impacts

As risk management actions are carried out, we will monitor and track progress on short-term objectives. We will also measure the long-term impacts of our actions and strategies and evaluate the effectiveness of the program in managing the risks we have prioritized. The information and insights generated from these metrics and evaluations will enhance the HFP’s ability to better develop, prioritize, and execute risk management strategies and actions in the long-term. 

Resource Management & Strategic Planning

Strategic management processes, including resource management and strategic planning, ensure the effective operations of the program. 

Quality Assessment and Management

Throughout the program, we use quality assessment and management approaches to design, assure, and improve the effectiveness of the procedures used to generate data inputs for the surveillance strategy, develop risk management strategies, and implement risk management actions. 

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