Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems.

Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more.

Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.

Contents

• THE NATIONAL ACADEMIES
• COMMITTEE ON THE REVIEW OF THE FOOD AND DRUG ADMINISTRATION’S ROLE IN ENSURING SAFE FOOD
• Reviewers
• Preface
• Summary
• Part I. Setting the Stage for Understanding and Improving the U.S. Food and Drug Administration’s Role in the Food Safety System
  • 1. Introduction
    • STUDY CONTEXT
    • PURPOSE AND SCOPE OF THIS STUDY
    • METHODS
    • ORGANIZATION OF THE REPORT
    • REFERENCES
  • 2. The Food Safety System: Context and Current Status
    • A CHANGING WORLD
    • LIMITS ON FOOD SAFETY
    • OVERVIEW OF THE CURRENT FOOD SAFETY SYSTEM
    • RECENT ANALYSES OF FOOD SAFETY MANAGEMENT AT THE FDA
    • LOOKING FORWARD
    • REFERENCES
• Part II. Toward a Stronger and More Effective Food Safety System
  • 3. Adopting a Risk-Based Decision-Making Approach to Food Safety
    • A RISK-BASED APPROACH TO FOOD SAFETY MANAGEMENT
    • MOVING TOWARD THE DEVELOPMENT OF A COMPREHENSIVE RISK-BASED APPROACH TO FOOD SAFETY MANAGEMENT
    • RELATIONSHIP BETWEEN RISK ANALYSIS AND THE RISK-BASED FOOD SAFETY SYSTEM
    • THE ROLE OF RISK ANALYSIS IN THE FDA’S CURRENT FOOD SAFETY MANAGEMENT PROGRAM
    • COMPARISON OF THE CURRENT FDA APPROACH TO RISK MANAGEMENT AGAINST THE VISION AND ATTRIBUTES OF A TRUE RISK-BASED DECISION-MAKING APPROACH TO FOOD SAFETY MANAGEMENT
    • IMPLEMENTATION OF A RISK-BASED FOOD SAFETY MANAGEMENT SYSTEM
    • KEY CONCLUSIONS AND RECOMMENDATIONS
    • REFERENCES
  • 4. Sharing the Responsibility for a Risk-Based System: Models of Governance and Oversight
    • OVERALL APPROACH TO MAKING GOVERNANCE DECISIONS AND DEVELOPING A REGULATORY PHILOSOPHY
    • CHOOSING POLICY INTERVENTIONS AND ASSIGNING/SHARING RESPONSIBILITY
    • KEY CONCLUSIONS AND RECOMMENDATIONS
    • REFERENCES
• Part III. Implementation of the New Food Safety System
  • 5. Creating an Integrated Information Infrastructure for a Risk-Based Food Safety System
    • THE ROLE OF DATA IN A RISK-BASED FOOD SAFETY MANAGEMENT SYSTEM
    • DATA NEEDS FOR A RISK-BASED SYSTEM
    • GAPS AND CHALLENGES IN THE CURRENT DATA COLLECTION SYSTEMS
    • MOVING FORWARD: DESIGNING AND IMPLEMENTING AN INTEGRATED INFORMATION INFRASTRUCTURE
    • KEY CONCLUSIONS AND RECOMMENDATIONS
    • REFERENCES
  • 6. Creating a Research Infrastructure for a Risk-Based Food Safety System
    • INTRAMURAL RESEARCH PORTFOLIO CFSAN
    • NCTR
    • CVM
    • ORA
    • EXTRAMURAL RESEARCH CENTERS
    • INTERAGENCY COLLABORATION
    • WEAKNESSES IN THE FDA RESEARCH PROGRAM
    • USING RESEARCH TO SUPPORT A RISK-BASED FOOD SAFETY MANAGEMENT APPROACH
    • MOVING FORWARD
    • KEY CONCLUSIONS AND RECOMMENDATIONS
    • REFERENCES
  • 7. Integrating Federal, State, and Local Government Food Safety Programs
    • PREVIOUS RECOMMENDATIONS FOR THE INTEGRATION OF FOOD SAFETY PROGRAMS
    • STATES CALL FOR INTEGRATION
    • ADEQUACY OF STATE AND LOCAL GOVERNMENT FOOD SAFETY REGULATORY PROGRAMS
    • FDA INTERACTIONS AND COLLABORATIONS WITH THE STATES
    • INTEGRATION THROUGH STANDARDIZATION AND OVERSIGHT OF FOOD SAFETY PROGRAMS
    • KEY CONCLUSIONS AND RECOMMENDATIONS
    • REFERENCES
  • 8. Enhancing the Efficiency of Inspections
    • BACKGROUND
    • EFFICIENCY OF INSPECTIONS
    • CAPITALIZING ON FOOD INSPECTIONS: USE OF STATE INSPECTORS AS PRIMARY FOOD INSPECTORS
    • USE OF THIRD-PARTY AUDITS AS A SUBSTITUTE FOR INSPECTIONS
    • KEY CONCLUSIONS AND RECOMMENDATIONS
    • REFERENCES
  • 9. Improving Food Safety and Risk Communication
    • FOOD RISK COMMUNICATION AND EDUCATION AT THE FDA
    • COMMUNICATING AT A TIME OF CRISIS: FOOD RECALLS AND OUTBREAKS
    • EDUCATING THE FOOD INDUSTRY
    • OTHER TARGETED POPULATIONS
    • MECHANISMS FOR EFFECTIVE INFORMATION EXCHANGE AND TRANSPARENCY
    • RESEARCH, EVALUATION, AND CONTINUOUS IMPROVEMENT
    • KEY CONCLUSIONS AND RECOMMENDATIONS
    • REFERENCES
  • 10. Modernizing Legislation to Enhance the U.S. Food Safety System
    • FACILITY REGISTRATION
    • PREVENTIVE CONTROLS
    • PERFORMANCE STANDARDS
    • RISK-BASED INSPECTION
    • ACCESS TO RECORDS
    • TRACEABILITY
    • MANDATORY RECALL
    • REPORTING OF ADULTERATION
    • AUTHORITY TO BAN ALL FOOD IMPORTS FROM A COUNTRY
    • KEY CONCLUSIONS AND RECOMMENDATIONS
    • REFERENCES
  • 11. Achieving the Vision of an Efficient Risk-Based Food Safety System
    • ISSUES RELEVANT TO REORGANIZATION AND RESOURCE ALLOCATION
    • UNIFICATION OF FOOD SAFETY ACTIVITES ACROSS MULTIPLE AGENCIES AND DEPARTMENTS
    • KEY CONCLUSIONS AND RECOMMENDATIONS
    • REFERENCES
• Appendixes
  • Appendix A Workshop Agendas
  • Appendix B Past Recommendations About the U.S. Food and Drug Administration’s Food Safety Program
  • Appendix C Food Safety Systems in the United States and Other Countries
  • Appendix D The U.S. Food and Drug Administration’s Food Defense Program
  • Appendix E The U.S. Food and Drug Administration and Imported Food Safety^,
  • Appendix F Food Safety Research at Intramural and Extramural U.S. Food and Drug Administration Research Centers, by Topic
  • Appendix G U.S. Food and Drug Administration Food Protection Plan
  • Appendix H Glossary
  • Appendix I Acronyms and Abbreviations
  • Appendix J Committee Member Biographical Sketches

This study was supported by Contract No. HHSF2232008100201 between the National Academy of Sciences and the Food and Drug Administration of the U.S. Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

Suggested citation:

IOM (Institute of Medicine) and NRC (National Research Council). 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.