Source: FDA, 5/2/14
 
The FDA Food Safety Modernization Act (FSMA) gives FDA a new public health mandate. It directs FDA to establish standards for adoption of modern food safety prevention practices by those who grow, process, transport, and store food. It also gives FDA new mandates, authorities and oversight tools aimed at providing solid assurances that those practices are being carried out by the food industry on a consistent, on-going basis.  

FDA is in the midst of the rulemaking and guidance development process required to establish the new prevention-oriented standards, and FSMA implementation teams have developed many ideas for how FDA can better oversee the food industry, strengthen the global food safety system, and enhance protection of public health. Planning has also begun for the next phase of FSMA implementation, which involves operationalizing the new public health prevention standards and implementing on the ground the strategic and risk-based industry oversight framework that is at the heart of FSMA.  

This strategy document is intended to guide the next phase of FSMA implementation by outlining broadly the drivers of change in FDA’s approach to food safety and the operational strategy for implementing that change, as mandated and empowered by FSMA. The appendix provides guiding principles for how the strategy can be implemented with respect to food and feed facilities, produce safety standards, and import oversight. This document will guide the work of teams responsible for developing the specific strategies, capacity building, training, and operational plans needed to implement FSMA in these areas.  It also provides the basis for dialogue with FDA’s government partners and other stakeholders concerning implementation of the FSMA rules. 

Drivers of Change in FDA’s Food Safety Role  
Congress enacted FSMA in response to dramatic changes over the last 25 years in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system. These food system changes and the new FSMA mandates require transformative change in how FDA does its work.

The central external force driving change is the dramatic expansion in the global scale and complexity of the food system. Hundreds of thousands of growers and processors worldwide are producing food for the U.S. market, using increasingly diverse and complicated processes, managing complex and extended supply chains, and making millions of decisions every day that affect food safety. The burgeoning scale and complexity of the food system make it impossible for FDA on its own, employing our historic approaches, to provide the elevated assurances of food safety envisioned by FSMA and needed to maintain a high level of consumer confidence in the safety of the food supply.

Accompanying this change is the now widely shared understanding that the foundation for reducing the risk of preventable foodborne illness in today’s global food system—and providing consumers the assurances of food safety they seek—is action by the food industry. Specifically, food safety depends primarily on the food industry, with top-level management commitment and working in a continuous improvement mode, to: (1) implement science- and risk-based preventive measures at all appropriate points across the farm-to-table spectrum, and (2) manage their operations and supply chains in a manner that provides documented assurances that appropriate preventive measures are being implemented as a matter of routine practice every day. FSMA is grounded in this understanding of how food safety can be protected in today’s global food system.  

While FSMA reinforces industry’s primary role and responsibility for food safety, it also builds on and strengthens FDA’s oversight role in providing technical expertise, setting and fostering compliance with food safety standards, and responding to and learning from problems when they do occur. In fact, more so than ever before, FDA is called upon by FSMA to play a central leadership and operational role in the future global food safety system. Meeting this challenge—and successfully implementing FSMA’s new prevention-oriented, systems approach to food safety—necessitates a new strategy for how FDA performs its food safety role and meets its new responsibilities.   

An Operational Strategy for the Future
The new approach and operational strategy for FDA’s food safety program and implementation of FSMA includes these elements: 
Advancing Public Health
•      FDA’s primary focus will be on improved public health outcomes—namely reducing the risk of foodborne illness—achieved by fostering broad, consistent industry implementation of modern preventive practices, as called for by FSMA and FDA’s implementing rules and guidance.    
•      FDA will play a central public health leadership role as a catalyst for innovation and action to improve food safety and as a primary source and repository of the science and expertise needed to understand and prevent food safety problems. 
•      To achieve better public health outcomes, FDA will focus its industry oversight efforts on using a broad array of tools to ensure that firms are consistently implementing effective prevention systems that protect food safety, within their operations and through their supply chains; this will include developing legally sufficient evidence to prove specific rule violations when judicial enforcement is the right remedy, but FDA will focus primarily on assessing whether systems are working effectively to prevent problems and on taking immediate action to protect public health through voluntary corrective action or a range of administrative remedies.  
Leveraging and Collaborating
•      FDA will leverage the resources and efforts of others by working in partnership to create an integrated global food safety network that includes our partner agencies (federal, state, local, tribal, territorial, and foreign agencies), international organizations, the food industry, growers, academic experts, and consumers.
•      To optimize the effectiveness, efficiency, and consistency of FSMA implementation domestically, FDA will enhance operational partnerships with states and other government counterparts, as envisioned in FSMA's call for a national integrated food safety system.
•      FDA will build robust data integration and analysis systems and information sharing mechanisms to support active operational partnership and foster mutual reliance with trusted partners.
Strategic and Risk-Based Industry Oversight
•      Given the scale and complexity of the global food system and the demand for higher levels of assurance that prevention systems are working properly, FDA will use an expanded oversight tool kit that includes both traditional and new tools, such as:
o      commodity- and sector-specific guidance on implementation of prevention-oriented standards;
o      education and outreach to industry to ensure expectations and requirements are understood;
o      technical assistance to facilitate compliance, especially by small and mid-size operators;
o      regulatory incentives for compliance, such as less frequent or intense inspection for good performers;
o      reliable third-party audits to verify compliance;
o      public education, transparency, and publicity to promote compliance and prevention; and
o      modernized approaches to inspection and enforcement based on the prevention framework and the enhanced inspection and enforcement tools provided by FSMA.
•      To carry out this broader approach to food safety, FDA will expand the skills and capacities of its scientific, technical and operational staff and change its internal operational practices to enable the agency to make quick decisions and take immediate action when needed to protect public health, using an array of tools, and working more closely with partner agencies to coordinate compliance and enforcement efforts.    
•      FDA will change its own resource planning and deployment to ensure FDA resources are used optimally in a flexible, risk-based, and efficient manner to achieve better public health outcomes and will develop public health outcome metrics that help measure the impact of our actions.
•      FDA will improve the quality and quantity of data it uses in order to fully evaluate and make the most informed, risk-based decisions. 

Enterprise-Wide Collaboration within FDA
Fulfilling the vision of risk-based prevention to protect public health—and successfully implementing FSMA—depends on close partnership and full integration of all implementation efforts carried out across the Foods and Veterinary Medicine Program, at both the work planning and operational levels. This integrated and collaborative approach involves CFSAN, CVM, ORA, the Office of Global Regulatory Operations and Policy, and the Office of Foods and Veterinary Medicine, and includes:
Planning  
•      Establishment of internal performance metrics that are aligned with the risk-based, public health-focused, prevention vision
•      Seamless data sharing and collaborative data analysis among all elements of the Foods and Veterinary Medicine Program related to risk-based priority setting and resource allocation
•      Global and national work planning of frontline oversight activities to maximize alignment with the risk-based public health vision and metrics 
•      Systematic and transparent evaluation of performance and outcomes to inform future planning

Execution
•      Strengthened, real-time subject matter expert support for frontline oversight activities before, during and after inspections
•      Streamlined processes to enable real-time decisions regarding frontline corrective actions, enforcement, and other measures to achieve public health and consumer protection
•      Well-defined processes for timely resolution, at the appropriate level, of broader strategy and policy issues

Evaluation  
•      Establishment of program-wide, public health-oriented outcome metrics
•      Systematic collection and program-wide sharing of data related to evaluation
•      Collaborative evaluation of program performance and outcome metrics

Conclusion
FDA will fulfill the vision of FSMA and strengthen food safety protection by applying the principles outlined here across the entire food safety program, while adapting them to the specific challenges posed by implementation of preventive controls, produce safety standards, and FSMA’s new import system, as outlined in the appendix that follows.    

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