Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)
Protecting Public Health by Strategic Implementation of Prevention-Oriented Food Safety Standards
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:
- commodity- and sector-specific guidance on implementation of prevention-oriented standards;
- education and outreach to industry to ensure expectations and requirements are understood;
- technical assistance to facilitate compliance, especially by small and mid-size operators;
- regulatory incentives for compliance, such as less frequent or intense inspection for good performers;
- reliable third-party audits to verify compliance;
- public education, transparency, and publicity to promote compliance and prevention; and
- 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:
- 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
- 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
- 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
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.
Appendix - Guiding Principles for Implementing the Operational Strategy
FDA’s operational strategy for implementing FSMA applies across all aspects of our food and feed safety program. The manner in which our strategy is implemented will vary, however, based on the nature and degree of risks posed by specific commodities, sectors, and facilities; the availability of interventions to reduce risk; the resources and tools available to FDA to provide oversight and reduce risk; and other factors.
The following are principles that will guide implementation of FSMA with regard to preventive controls in food and feed facilities, produce safety standards, and import oversight. While the operational strategy applies broadly to all these areas, each has its own attributes that call for tailored strategic approaches, as outlined below.
Guiding Principles for Implementation in Food and Feed Facilities
Implementation of FSMA’s preventive controls mandate in food and feed facilities will build on FDA’s experience implementing Hazard Analysis Critical Control Point (HACCP) in seafood and juice processing operations, specifically FDA’s familiar roles in issuing rules and guidance and conducting inspections to assess and enforce compliance. Implementation of preventive controls must differ, however, due to the much larger number and diversity of covered facilities, FSMA’s new records access and administrative enforcement tools, and FDA’s commitment to the expanded tool kit for strategic and risk-based industry oversight outlined in the operational strategy.
FSMA provides FDA for the first time an inspection frequency mandate for food and feed facilities, but FSMA’s public health prevention framework demands transformative change in how FDA uses its inspection authority and traditional and enhanced enforcement tools to carry out its oversight responsibility and protect public health in the most efficient manner possible.
Inspection and Surveillance
FDA will significantly expand its inspection and surveillance tools to include a wider range of inspection, sampling, testing, and other data collection activities conducted through its own field force and through collaboration with partner agencies and the food industry.
The types and purposes of inspection and surveillance will include:
- Efficiently screening firms for food safety performance to guide risk-based inspection priority, frequency, depth, and approach
- Providing firms incentives for compliance through enhanced presence in and targeted scrutiny of high-risk firms and products and reduced scrutiny of firms with records of demonstrated good performance
- Assessing the compliance of individual firms through a range of inspection and sampling techniques used in a strategic, risk-based way to maximize coverage of priority sectors and firms
- Making in-depth assessments of individual firms when needed to increase the incentive for compliance and determine the need for compliance or enforcement actions
- Collecting data to inform understanding and analysis of sector-wide hazards, practices, and preventive control deficiencies
- Collecting data on compliance rates to evaluate program performance and plan future efforts
Administrative Compliance Tools
FSMA’s public health prevention focus and new administrative enforcement tools mean that FDA’s primary tools for correcting preventive control deficiencies and resolving problems that put consumers at risk will be administrative compliance actions, rather than court enforcement cases, including:
- Voluntary correction of problems at the facility level, achieved immediately during the course of an inspection through communication with firm management by investigators and, as needed, Center technical staff
- Voluntary correction achieved at the District level through deficiency letters, issued within days after an inspection with Center back up, to document significant safety-related deficiencies and request correction within a specified period, with immediate inspection follow up to verify correction
- Administrative detention of product if needed to provide immediate public health protection or for other appropriate purposes.
- Voluntary and mandatory recalls to remove potentially hazardous food from the market
- Administrative suspension of registration when other administrative compliance measures have failed or are inadequate to achieve correction of significant deficiencies that put consumers at risk
Judicial Enforcement Tools
Enforcement includes judicial actions when necessary to complement non-judicial compliance actions and address matters for which there is no adequate administrative remedy, such as:
- Seizure actions that are needed to back up administrative detentions
- Injunction actions when suspension of registration or other measures are inadequate to prevent future non-compliance
- Criminal prosecution for falsifying records, lying to FDA, knowingly putting consumers at risk, or in other appropriate cases
Guiding Principles for Implementation of Produce Safety Standards
Effective implementation and oversight of produce safety standards poses distinct challenges for FDA due to the scale and diversity of the produce sector, the large number of produce farms, and their lack of familiarity with FDA regulatory oversight. Moreover, Congress envisioned a different role for FDA on produce farms compared to food facilities, as reflected in the lack of an inspection frequency mandate in FSMA for farms, the directive to coordinate education and enforcement activities with state and local officials , and the mandate to USDA to provide technical assistance grants to support implementation, especially for entities such as small growers.
Another reality shaping FDA’s approach to produce safety is that there is no reasonable expectation FDA will have the resources to make routine on-farm inspection a major source of accountability for compliance with produce safety standards.
For this reason, FDA’s implementation of produce safety standards will entail a broad, collaborative effort to foster awareness and compliance through guidance, education, and technical assistance, coupled with accountability for compliance from multiple public and private sources, including FDA and partner agencies, USDA audits, marketing agreements, and private audits required by commercial purchasers.
In keeping with this broad vision for FSMA implementation, FDA will focus its efforts on:
- Deploying a cadre of produce safety experts in headquarters and the field with the depth and breadth of capacity to develop the guidance needed to support implementation and provide technical support to government and industry parties working to foster compliance
- Actively supporting education and technical assistance for growers, primarily through collaboration with other public and private parties
- Supporting public and private parties involved in audits and other accountability functions with technical assistance and other collaborative support
- Conducting targeted on-farm surveys and inspections to understand current practices and identify gaps in compliance
- Taking administrative compliance and enforcement action when needed to correct problems that put consumers at risk
- Responding to produce outbreaks effectively to lessen impact on public health
- Conducting in-depth environmental assessments where appropriate to identify root causes of outbreaks associated with produce and inform future prevention efforts
Guiding Principles for Implementation of FSMA’s New Import System
FSMA provides FDA with a multi-faceted new tool kit for import oversight that is intended to ensure that imported foods are produced using modern preventive measures that achieve the same level of food safety protection as FSMA’s new preventive control and produce safety standards. FDA will use the new tool kit to build a prevention-oriented import system that provides much-heightened assurances about the safety of imported food.
Rather than relying primarily on FDA detecting and stopping food safety problems at the border, the new system relies primarily on importers providing documented assurances that their foreign suppliers have taken proper steps to prevent problems. To complement FDA’s oversight of importers, FSMA directs FDA to strengthen private audit systems, increase its overseas presence, and work in partnership with foreign governments to strengthen and capitalize on their capacity to help ensure the safety of food destined for the United States, all in keeping with the collaboration and leveraging elements of our operational strategy for FSMA implementation.
FDA will use all elements of the FSMA tool kit to provide the heightened assurances of food safety called for by Congress and expected by consumers in a manner that makes efficient use of FDA’s resources and leverages the resources and efforts of others.
Key features of FDA’s import implementation effort will include:
- Developing the skills, capacity, and processes to audit foreign supplier verification programs and hold importers accountable for effectively managing their supply chains in accordance with FSMA
- Reconfiguring current import screening and field exam activities to complement oversight of FSMA’s foreign supplier verification requirement and ensure that FDA is making strategic, risk-based use of its import oversight resources
- Implementing the voluntary qualified importer program and other measures to expedite entries for good performers and thereby allow more resources to be directed toward high-risk imports
- Developing the skills, capacity, and processes to audit accrediting bodies and accredited third-party certifiers, with the goal of enhancing the rigor, objectivity, and transparency of private audits and their contribution to assuring the safety of imported food
- Developing the skills, capacity, and processes to conduct comparability assessments of foreign government regulatory systems as the basis for relying, where justified, on foreign oversight, minimizing duplication of effort, and improving risk-based resource allocation
- Building data integration and analysis systems and harnessing all available sources of relevant information to strengthen risk-based targeting of resources