Enhancing Food Safety The Role of the Food and Drug Administration (2010) / Chapter Skim
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Appendix G: U.S. Food and Drug Administration Food Protection Plan
Appendix G: U.S. Food and Drug Administration Food Protection Plan
Pages 505-554
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Appendix G U.S. Food and Drug Administration Food Protection Plan An integrated strategy for protecting the nation's food supply November 2007 U.S.
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0 ENHANCING FOOD SAFETY "Americans enjoy unprecedented choice and conenience in filling the cupboard today, but we also face new challenges to ensuring that our food is safe. This Food Protection Plan will implement a strategy of preention, interention and response to build safety into eery step of the food supply chain." Michael O
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FDA staff continue to work diligently to protect our food supply, by containing outbreaks and preventing further illnesses. With this FDA Food Protection Plan we are going even further.
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Use science and modern technology systems, 528 V The Integrated Plan 529 • Core Element #1: Prevention, 529 1.1 Promote Increased Corporate Responsibility to Prevent Foodborne Illnesses, 531 1.2 Identify Food Vulnerabilities and Assess Risks, 535 1.3 Expand the Understanding and Use of Effective Mitigation Measures, 536 • Core Element #2: Intervention, 537 2.1 Focus Inspections and Sampling Based on Risk, 538 2.2 Enhance Risk-Based Surveillance, 541
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0 APPENDIX G 2.3 Improve the Detection of Food System "Signals" That Indicate Contamination, 544 • Core Element #3: Response, 545 3.1 Improve Immediate Response, 546 3.2 Improve Risk Communications to the Public, Industry and Other Stakeholders, 549 VI. Enhance Information Technology 551 VII.
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The Food Protection Plan operates through a set of integrated strategies that: • Focus on risks over a product's life cycle from production to consumption • Target resources to achieve maximum risk reduction • Address both unintentional and deliberate contamination • Use science and modern technology systems FDA's Integrated Plan Provides Three Elements of Protection PREVENT Foodborne Contamination • romote Increased Corporate Responsibility to Prevent Foodborne P Illnesses • Identify Food Vulnerabilities and Assess Risks • Expand the Understanding and Use of Effective Mitigation Measures INTERVENE at Critical Points in the Food Supply Chain • Focus Inspections and Sampling Based on Risk • Enhance Risk-Based Surveillance • mprove the Detection of Food System "Signals" That Indicate I Contamination RESPOND Rapidly to Minimize Harm • Improve Immediate Response • mprove Risk Communications to the Public, Industry and Other I Stakeholders FDA recognizes the need to partner with Congress to make the changes necessary to transform the safety of the nation's food supply. This plan identifies the administrative actions we are proposing to take within the Agency.
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Firms to Export Their Products • rovide Parity Between Domestic and Imported Foods if FDA P Inspection Access is Delayed, Limited, or Denied RESPOND Rapidly to Minimize Harm • mpower FDA to Issue a Mandatory Recall of Food Products When E Voluntary Recalls Are Not Effective • ive FDA Enhanced Access to Food Records During Emergencies G FDA plans to enhance its information technology (IT) capabilities to fully support the implementation of the FDA Food Protection Plan.
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ENHANCING FOOD SAFETY To download a copy of this report, go to http://www.fda.gov/FDAgov/Food/ FoodSafety/FoodSafetyPrograms/FoodProtectionPlan2007/ucm132565.htm or for a pdf version go to http://www.fda.gov/FDAgov/downloads/RegulatoryInformation/Guidances/ucm132573.PDF. For more in-depth information on the many programs FDA has underway to protect the nation's food supply, go to the Food Protection main page at http://www.fda.gov/FDAgov/Food/FoodSafety/FoodSafetyPrograms/Food ProtectionPlan2007/default.htm.
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Leavitt and Commissioner of Food and Drugs Andrew C von Eschenbach, M.D., charged FDA with developing a comprehensive and integrated FDA Food Protection Plan to keep the nation's food supply safe from both unintentional and deliberate contamination.
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monitors foodborne microorganisms that cause illness and tracks trends. Relative rates compared with 1996-1998 baseline period of laboratory-diagnosed cases of infection with Campylobacter, STEC O157, Listeria, Salmonella and Vibrio, by year.
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The graph also represents illnesses from foods not regulated by FDA. FDA is committed to strengthening the nation's food protection system through implementation of the FDA Food Protection Plan.
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ENHANCING FOOD SAFETY other food outlets.3 FDA provides guidance, model codes, and other technical assistance to state and local partners. • Approximately 189,000 registered foreign facilities manufacture, process, pack, or hold food consumed by Americans.
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These bags of salad end up in thousands of homes, potentially resulting in hundreds of illnesses. The shifting demographics have increased the numbers of susceptible consumers, and the convenience factors have meant that small problems can lead to large outbreaks -- both indications of the need to make changes to ensure a continued high level of food protection.
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ENHANCING FOOD SAFETY Shifting Demographics Our population demographics are changing. Shifting demographics means that more of the U.S.
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food supply by volume is imported. However, in certain food categories a much higher percentage is imported.
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Today, foods that are inherently more likely to pose risks, such as ready-to-eat food products, fresh produce and seafood, account for an increasing proportion of imported foods. Figure G-2 This is not to suggest that food imported into the United States, as a R01720 whole, poses a greater food safety risk than domestically produced food.
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Foodborne illnesses are caused by more than 200 different foodborne pathogens (agents that can cause illness) of which we are currently aware.
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Though not considered an act of terrorism, the incident appeared to be a deliberate act for economic gain. It resulted in the sickness and deaths of cats and dogs, the recall of hundreds of brands of pet food products, state quarantine or voluntary holds on livestock that consumed suspect animal feed, and concern regarding the possible associated human health risks.
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Data from the testing of food, inspections, and reports of illnesses are collected in federal and state systems. Data from foodborne illness and pathogen identification are entered into systems maintained by the CDC, the lead federal agency for conducting disease surveillance and outbreak investigations.
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Core Elements While American consumers enjoy one of the safest food supplies in the world, growing challenges require a new approach to food protection at FDA -- an increased emphasis on prevention. Recent outbreaks linked to fresh produce, peanut butter, and pet foods show how FDA responds quickly to contain food safety problems.
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These measures will promote improved food protection capabilities throughout the food supply chain. This will require close interaction with growers, manufacturers, distributors, retailers and food service providers, and importers.
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Cross-Cutting Principles Principles of the Food Protection Plan • ocus on risks over a product's life cycle from production to F consumption. • Target resources to achieve maximum risk reduction.
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Implementation of the Food Protection Plan will involve acquiring the data to best address risk, or, where the data is unavailable, working with appropriate partners to determine those risks. Those at highest risk for serious foodborne illness include young children, older adults, pregnant women, and people with weakened immune systems.
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For example, successful intervention relies in large part on the science of epidemiology to understand which foods pose risks and the science of modern detection methods to identify harmful agents quickly. The Food Protection Plan also highlights the need to further integrate information systems.
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The Plan's Key Prevention Steps • Promote Increased Corporate Responsibility to Prevent Foodborne Illnesses • Identify Food Vulnerabilities and Assess Risks • Expand the Understanding and Use of Effective Mitigation Measures FDA designed its Plan for the full life cycle of food -- from production to consumption, whether it be domestic or imported. The prevention elements of the Plan emphasize the importance for FDA and corporations to work collaboratively to prevent food problems from occurring.
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Some examples of enhanced corporate responsibility might include: • evaluating safety and security vulnerabilities and possible impacts • when appropriate, implementing preventive measures -- both required and voluntary -- to ensure that food is produced safely and securely • developing a contingency plan to aid in a response in the event of contamination The Food Protection Plan builds on partnerships and directs resources to the areas of greatest risk.
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APPENDIX G 1.1 PROMOTE INCREASED CORPORATE RESPONSIBILITY TO PREVENT FOODBORNE ILLNESSES STRENGTHEN FDA ACTIONS • eet with states and consumer groups to solicit their input on imple M menting preventive approaches to protect the food supply. • Meet with food industry representatives to strengthen science-based voluntary prevention efforts, including developing best business prac tices and food safety guidelines.
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FDA also proposes that firms be extended an affirmative defense in civil litigation if they comply with these controls. Authorize FDA to Issue Additional Preventive Controls for High-Risk Foods The FDA requests explicit authority to issue regulations requiring specific types of foods (those that have been associated with repeated instances of serious health problems or death to humans or animals from unin tentional contamination)
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FDA will continue to work with industry in a) developing food protection plans that address safety and defense vulnerabilities, b)
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This may include the examination of best practices around the food safety control systems of other countries as well as increased understanding of the difficulties faced in implementing food protection measures. FDA will also seek to share U.S.
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ADDITIONAL LEGISLATIVE AUTHORITY NEEDED None. WHY THESE ACTIONS ARE IMPORTANT AND WHAT THEY WILL ACCOMPLISH These FDA actions provide important tools to facilitate increased corporate responsibility to prevent food contamination.
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FDA's current and planned actions would: • Strengthen the FDA's risk assessment capabilities and capacity to provide risk evaluations efficiently and rapidly. • Advance collaborative work with CDC, USDA, and other federal, state and local agencies to understand attribution data on the food commodities that cause foodborne illnesses.
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The Plan's Key Intervention Steps Focus Inspections and Sampling Based on Risk • Enhance Risk-Based Surveillance • Improve the Detection of Food System "Signals" that Indicate • Contamination These steps emphasize targeted interventions at the point of manufacture and during distribution. They allow FDA to safeguard domestic products while increasing protection against importation of unsafe food.
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Gathering and analyzing test results, adverse event reports, consumer complaints, and other information will help the FDA track emerging food protection problems. 2.1 FOCUS INSPECTIONS AND SAMPLING BASED ON RISK STRENGTHEN FDA ACTIONS • ocus food and feed safety inspections and sampling based on risk.
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APPENDIX G To establish such an accreditation program for voluntary food inspec tions, FDA would undertake a public process to determine best practices and solicit industry input in the design of the program. An FDA accredita tion program would require FDA to accredit third-party organizations, or recognize an entity that accredits third parties.
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Better detection tools will allow FDA and other partners involved in food testing to more quickly and accurately detect contaminants. Because of its relevant expertise and experience, the FDA has unique capabilities to develop these tools.
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• Modernized inspectional strategies. 2.2 ENHANCE RISK-BASED SURVEILLANCE STRENGTHEN FDA ACTIONS • urther enhance FDA's ability to target imported foods for inspection F based on risk and publish the Prior Notice of Imported Foods Final Rule in 2008 as part of Bioterrorism Act implementation.
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ENHANCING FOOD SAFETY ADDITIONAL LEGISLATIVE AUTHORITY NEEDED Authorize FDA to Require Electronic Import Certificates for Shipments of Designated High-Risk Products For food imports, the burden falls primarily on FDA to inspect and detect contamination at the U.S. border.
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The authority would include several procedural safeguards, including an informal hearing if food is refused admission into the United States, such as is available for food that may be refused entry for other reasons. WHY THESE ACTIONS ARE IMPORTANT AND WHAT THEY WILL ACCOMPLISH FDA must prevent products that pose food safety and food defense threats from entering the United States.
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FDA's current and planned actions, along with the proposed legislative changes, would: • Better focus on the imported products' total life cycle. • Improve data systems to monitor foreign-produced food products.
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by improving its adverse event and consumer complaint reporting systems. This additional information will serve as a supplemental warning indicator for trending emerging food protection problems.
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food supply following an incident. The Plan's Key Response Steps Improve Immediate Response • Improve Risk Communications to the Public, Industry and Other • Stakeholders 3.1 IMPROVE IMMEDIATE RESPONSE STRENGTHEN FDA ACTIONS • nhance the data collection, incident reporting and emergency E response mapping capabilities of FDA's Emergency Operations Net work Incident Management System.
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Provide FDA Enhanced Access to Food Records During Emergencies During food-related emergencies, the FDA needs more complete and streamlined access to records necessary to identify the source of food borne illness and take needed action. Improved access to information, including records related to an article of food or related articles of food that may present a threat, will enhance FDA's ability to identify problems, respond quickly and appropriately, and protect public health.
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FDA will also increase collaboration with foreign, state, and local regulators to identify the source of contamination, remove contaminated products as quickly as possible, and implement measures needed to prevent future contamination. These improvements will allow FDA to quickly isolate problems, prevent contaminated products from reaching consumers, and ensure targeted recalls of products.
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ADDITIONAL LEGISLATIVE AUTHORITY NEEDED None. WHY THESE ACTIONS ARE IMPORTANT AND WHAT THEY WILL ACCOMPLISH Consumers protect themselves and their families from foodborne illness by responding promptly to FDA alerts.
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FDA's current and planned actions will enable the FDA to: • Communicate more effectively with consumers. • Provide more rapid alerts to all stakeholders, including retailers, industry, public health officials, and the consumers.
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This affects the flow of goods into the United States, and poses a safety risk to consumers. An integrated, IT infrastructure -- with data gathering, sorting, mining, and trending capability built into the systems -- is critical to the success of FDA's food protection efforts.
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The Plan operates through a set of integrated strategies that address the product life cycle, a risk-based allocation of resources, the integration of food safety and food defense, and builds on a foundation of science and modern information systems. FDA's Food Protection Plan complements the nation's strategic framework for import safety, which was released by the U.S.
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APPENDIX G Figure G-4 R01720 color, portrait size uneditable bitmapped image
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