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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. Department of Health and Human Services

U.S. Food and Drug Administration



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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. Department of Health and Human Services U.S. Food and Drug Administration 0

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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. Leavitt Secretary of Health and Human Services U.S. Department of Health and Human Services

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0 APPENDIX G A MESSAGE FROM THE COMMISSIONER As a physician and the Commissioner of Food and Drugs, protecting Amer- ica’s food supply is extremely important to me. American consumers have one of the safest food supplies in the world, but the world is changing and we know it can be safer. New food sources, advances in production and distribution methods, and the growing volume of imports due to consumer demand call for a new approach to protecting our food from unintentional or deliberate contamination. The U.S. Food and Drug Administration (FDA) must keep pace with these changes so that the safety of the nation’s food supply remains second to none. In the past few years, FDA has introduced several initiatives that address microbial and other food safety hazards with domestic or imported produce and that guide industry practices in the safe production of fresh-cut fruits and vegetables. FDA has also worked hard to raise awareness about food defense issues and preparedness. These are just a few things we are doing to improve food safety and food defense. Recent nationwide recalls remind us how devastating foodborne illness can be. In the past year, contaminated peanut butter led to illnesses in more than 300 people and at least 50 hospitalizations. Contaminated spinach resulted in 206 illnesses, three deaths, and more than 100 people hospitalized. Reports of kidney failure and deaths in cats and dogs prompted a recall of more than 100 brands of pet food. For every one of these emergencies, the FDA responded immediately to min- imize harm. FDA investigators traced each problem’s source and worked without delay to remove the affected products from market shelves. 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. It is a forward-oriented concept that uses science and modern information tech- nology to identify potential hazards ahead of time. By preenting most harm before it can occur, enhancing our intervention methods at key points in the food production system, and strengthening our ability to respond immediately when problems are identified, FDA can provide a food protec- tion framework that keeps the American food supply safe. Andrew C. von Eschenbach, M.D. Commissioner of Food and Drugs

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0 ENHANCING FOOD SAFETY TABLE OF CONTENTS I. Executive Summary 510 II. Introduction 513 III. Changes and Challenges 517 • Trends in Demographics and Consumption, 517 o Shifting Demographics, 518 o Conenience Trends, 518 o Consumption Patterns, 519 • Global Food Supply, 519 • New Threats, 521 o New Foodborne Pathogens, 521 o Intentional Contamination, 522 • Communication, 523 IV. An Overview of the Approach 524 • Core Elements, 524 o Prevention—Build safety in from the start, 525 o Intervention—Verify prevention and intervene when risks are identified, 525 o Response—Respond rapidly and appropriately, 526 • Cross-Cutting Principles, 526 . Focus on risks oer a product’s life cycle from production to consumption, 526 . Target resources to achiee maximum risk reduction, 527 . Address both unintentional and deliberate contamination, 528 . 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. Conclusion 552

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0 ENHANCING FOOD SAFETY I. ExECUTIVE SUMMARY FDA is implementing a Food Protection Plan (the Plan) that addresses both food safety and food defense for domestic and imported products. The Plan is integrated with the Administration’s Import Safety Action Plan. 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. This Plan also recommends legislative changes to strengthen FDA’s ability to continue to protect Americans from foodborne illnesses.

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 APPENDIX G ADDITIONAL PROTECTIONS THAT INVOLVE LEGISLATIVE CHANGES TO FDA’S AUTHORITY PREVENT Foodborne Contamination • llow FDA to Require Preventive Controls to Prevent Intentional A Adulteration by Terrorists or Criminals at Points of High Vulnerability in the Food Chain • uthorize FDA to Issue Additional Preventive Controls for High-Risk A Foods • equire Food Facilities to Renew Their FDA Registrations Every R Two Years, and Allow FDA to Modify the Registration Categories INTERVENE at Critical Points in the Food Supply Chain • uthorize FDA to Accredit Highly Qualified Third Parties for A Voluntary Food Inspections • equire New Reinspection Fee From Facilities That Fail to Meet R current Good Manufacturing Practices (cGMPs) • uthorize FDA to Require Electronic Import Certificates for A Shipments of Designated High-Risk Products • equire New Food and Animal Feed Export Certification Fee to R Improve the Ability of U.S. 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. For More Information For follow up information on this report, contact: Kari Barrett Senior Advisor, Food Protection Team Room 14B-17 5600 Fishers Lane Rockville, MD 20857 Phone 301.827.9831 Email: FoodProtection@fda.hhs.gov

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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/Regula- toryInformation/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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 APPENDIX G II. INTRODUCTION Every day across the country, people eat out, buy groceries, and cook meals for their families. Americans expect that all their food will be safe, and FDA plays a critical role in making sure this is true. FDA is responsible for the safety of the vast range of food Americans eat; about 80 percent of all food sold in the United States. This includes everything except for meat, poultry, and processed egg products, which are regulated by the U.S. Department of Agriculture (USDA). In May 2007, Secretary of Health and Human Services Michael O. 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 uninten- tional and deliberate contamination. Driven by science and modern infor- mation technology, the Plan aims to identify potential hazards and counter them before they can do harm. A cornerstone of this forward-thinking effort is an increased focus on prevention. The Plan builds in safety measures to address risks throughout a product’s life cycle, from the time a food is produced to the time it is distributed and consumed. The Plan focuses FDA’s efforts on preventing problems first, and then uses risk-based interventions to ensure preventive approaches are effective. The Plan also calls for a rapid response as soon as contaminated food or feed is detected or when there is harm to people or animals. FDA’s integrated approach, within the Food Protection Plan, encompasses three core elements: prevention, intervention and response. • The preention element means promoting increased corporate responsibility so that food problems do not occur in the first place. By comprehensively reviewing food supply vulnerabilities and devel- oping and implementing risk reduction measures with industry and other stakeholders, FDA can best address critical weaknesses. • The interention element focuses on risk-based inspections, sam- pling, and surveillance at high risk points in the food supply chain. These interventions must verify that the preventive measures are in fact being implemented, and done so correctly. • The response element bolsters FDA’s emergency response efforts by allowing for increased speed and efficiency. It also includes the idea of better communication with other federal, state, and local government agencies and industry during and after emergencies. Whether contamination is unintentional or deliberate, there is a

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 ENHANCING FOOD SAFETY need to respond quickly and to communicate clearly with consum- ers and other stakeholders. The communication should emphasize identifying products of concern as well as assuring the public of what is safe to consume. Under its FoodNet program (www.cdc.gov/foodnet), the Centers for Dis- ease Control and Prevention (CDC) 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. This graph shows the progress that has been made in reducing food- borne infections. Other than recent increases in Vibr­io­ and Shiga toxin- producing Escher­ichia coli (STEC) O157-related illness, the incidence of illnesses associated with these foodborne microorganisms has mostly remained steady or gone down since the late 1990s, although further Figure G-1 progress is needed. Note that the graph represents all illnesses associ- R01720 ated with the five types of bacteria, not just that from contaminated food. The graph also represents illnesses from foods not regulated by FDA. color, portrait size uneditable bitmapped image Source: Centers for Disease Control and Prevention This graph shows the progress that has been made in reducing foodborne infections. Other than recent increases in Vibrio- and Shiga toxin-producing Escherichia coli (STEC) O157-related illness, the incidence of illnesses asso-

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 APPENDIX G ciated with these foodborne microorganisms has mostly remained steady or gone down since the late 1990s, although further progress is needed. Note that the graph represents all illnesses associated with the five types of bacteria, not just that from contaminated food. 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. The Plan’s stra- tegic and partnered activities are driven by science and incorporate the use of 21st-century technologies. Scope of the Food Three Core Protection Plan Elements 1. pplies to food for people A • Prevention and animals • Intervention 2. ddresses domestic and A • Response imported products 3. ncompasses food E safety (unintentional contamination) and food defense (deliberate contamination) FDA Regulates Roughly 80 Percent of the U.S. Food Supply • FDA regulates $417 billion worth of domestic food and $49 billion in imported food1 annually. • FDA has oversight of more than 136,000 registered domestic food facilities (including more than 44,000 U.S. food manufacturers and processors and approximately 113,000 U.S. food warehouses, including storage tanks and grain elevators).2 • FDA or state and local authorities regulate more than 2 million farms, roughly 935,000 restaurants and institutional food service establishments, and 114,000 supermarkets, grocery stores, and 1 Based on FDA value-of-shipment information, 2003. 2 Facilities that are engaged in more than one type of activity (e.g., manufacturing and warehousing) are counted in both categories; thus, the sum of the individual numbers of type of facilities exceeds the number of total registered facilities.

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 ENHANCING FOOD SAFETY of the imported product, through such means as enhanced use of informa- tion-sharing agreements with key foreign countries. In addition, FDA will continue to look for enhanced ways to use risk-based screening technology to identify products that pose health risks at the bor- der. For example, a screening technology prototype is currently being tested on imported seafood products in Los Angeles. If demonstrated successful, this technology could be extended to other imported products and ports, thus enhancing the FDA’s ability to quickly screen products at the border. 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. 2.3 IMPROVE THE DETECTION OF FOOD SYSTEM “SIGNALS” THAT INDICATE CONTAMINATION STRENGTHEN FDA ACTIONS • eploy new rapid screening tools and methods to identify pathogens D and other contaminants. • mprove FDA’s adverse event and consumer complaint reporting sys- I tems, including capturing complaints made to food manufacturers and distributors. • ork to create a Repor­table Food Registr­y for reports of a determina- W tion that there is a reasonable probability that the use of or exposure to an article of food will cause serious harm or death to humans or animals [as defined in the 2007 Food and Drug Administration Amendments Act (FDAAA)]. Under FDAAA, industry is expected to report such situations to the FDA within 24 hours. • Work to create an Ear­ly War­ning Sur­veillance and Notification System to identify adulterated pet food products, outbreaks of pet illness and to provide notice to veterinarians and other stakeholders during pet food recalls (as defined in the 2007 Food and Drug Administration Amendments Act or FDAAA).

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 APPENDIX G ADDITIONAL LEGISLATIVE AUTHORITY NEEDED None. WHY THESE ACTIONS ARE IMPORTANT AND WHAT THEY WILL ACCOMPLISH FDA can better detect and more quickly identify risk “signals” in the food supply chain via two key approaches: 1) deploying new rapid screening tools and methods to identify pathogens and other contaminants; and 2) enhancing its ability to “map” or trace adverse events back to their causes (whether reported to FDA or the food manufacturer or distributor) 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. To provide the information necessary to allow for early detection of, and intervention with, contaminated animal feed, FDA will develop a central- ized database for veterinarians that captures data on food safety incidents and the causes of food-related illness. The FDA will populate the database with key information from the veterinary community, veterinary hospitals, and other private U.S. sources. FDA’s current and planned actions would identify: • signals that may indicate a problem with food from routine test- ing, consumer complaints, industry reporting and documented illnesses. CORE ELEMENT #3: RESPONSE During the past year, FDA responded to food safety problems with con- taminated spinach, lettuce, vegetable proteins, and peanut butter, among other foods. Whether contamination is unintentional or deliberate, there is a need to respond faster and communicate more effectively with consumers and other partners. The following key response steps will increase FDA’s ability to quickly identify food safety problems, better coordinate a rapid emergency response among FDA, state and local government response teams as appropriate,

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 ENHANCING FOOD SAFETY and improve communications to the public, industry and other partners. This will better protect public health, help reduce the economic hardship affected industries face, and most importantly, maintain consumer confi- dence in the U.S. 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. • ork with stakeholders to develop an action plan for implementing W more effective trace-back process improvements and technologies to more rapidly and precisely track the origin and destination of contami- nated foods, feed, and ingredients. • ncrease collaboration with foreign, federal, state, and local FDA part- I ners to identify a contamination source, remove contaminated prod- ucts, and implement corrective actions. • ork with CDC and other selected federal, state, and local testing W labs to communicate real-time testing results among FDA and lab members.

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 APPENDIX G ADDITIONAL LEGISLATIVE AUTHORITY NEEDED Empower FDA to Issue a Mandatory Recall of Food Products When Voluntary Recalls Are Not Effective Although FDA has the authority to seize adulterated or misbranded food, this is not a practical option when contaminated product has already been distributed to hundreds or thousands of locations. And while the FDA has been able to accomplish most recalls through voluntary actions by product manufacturers or distributors, there are situations in which firms are unwilling to conduct a recall. In such situations FDA needs the ability to require a firm to conduct a recall to ensure the prompt and com- plete removal of food from distribution channels. This authority would be limited to foods that the Secretary has reason to believe are adulterated and present a threat of serious adverse health consequences or death. It would be imposed only if a firm refuses or unduly delays conducting a voluntary recall. An order to recall food could only be issued by the HHS Secretary, Deputy Secretary, or Commissioner of Food and Drugs, and would be accompanied by appropriate due process rights. 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. Currently, emergency access to records is limited to instances where, for an article of food, FDA has a reasonable belief that the food is adul- terated and presents a threat of serious adverse health consequences or death. FDA proposes to expand access to records of r­elated articles of food, such as food produced on the same manufacturing line. FDA also proposes, in food-related emergencies, to remove the adulteration requirement to allow its inspectors access to records in emergency situ- ations where FDA has a reasonable belief that an article of food presents a threat of serious adverse health consequences or death. The recent melamine situation in which FDA had early clinical evidence that a spe- cific food was causing illness in pets but did not have clear evidence of a specific adulteration is an example of such a scenario.

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 ENHANCING FOOD SAFETY The records access would relate only to safety or security of the food and would not apply to records pertaining to recipes, financial data, pricing data, personnel data, research data, and sales data. The require- ment would not impose any new recordkeeping burdens, and would maintain the current statutory exclusions for the records of farms and restaurants. WHY THESE ACTIONS ARE IMPORTANT AND WHAT THEY WILL ACCOMPLISH Recent food safety threats have demonstrated the importance of FDA’s emergency response system. Contaminant tracing—or identifying where the contaminant has traveled within the food or feed supply—is critical in rapidly containing potential risks. Working with partners, FDA will pursue improvements to the current trace-back process and develop an action plan for implementing process improvements to more rapidly and precisely track the origin and destination of contaminated foods, feed, and ingredients. As part of that effort, FDA will work with selected federal, state, and local testing labs to communicate real-time testing results among FDA and lab members. FDA will also increase collaboration with foreign, state, and local regula- tors 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, pre- vent contaminated products from reaching consumers, and ensure targeted recalls of products. Such steps aim to minimize the public health and eco- nomic impact from an outbreak. FDA’s current and planned actions, along with the proposed legislative changes, would: • Enhance the nation’s food emergency response system. • Expand the FDA’s trace-back process. • Improve multi-partner collaborations, including with foreign regulators.

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 APPENDIX G 3.2 IMPROVE RISK COMMUNICATIONS TO THE PUBLIC, INDUSTRY AND OTHER STAKEHOLDERS STRENGTHEN FDA ACTIONS • ork with communications and media experts, including FDA’s Risk W Communication Advisory Committee, to design and conduct con- sumer communications and behavior response studies. • pdate the Food Protection Risk Communications Plan using the U most effective strategies for sharing information with consumers. • Build a consumer Web site to communicate relevant food protection information. • n a food-related emergency, implement this communications plan, I including utilizing all relevant media and technologies to reach con- sumers, retailers, industry, public health officials, and other stakeholders resulting in a better informed and thus more resilient population. 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. Important messages must be communi- cated clearly and through multiple forms of media to be effective, because different segments of the population use different technologies, ranging from television and newspapers to text messages and podcasts. In addi- tion, major segments of the population do not use English as their primary language and rely on still other sources of information. This increases the challenge of implementing effective communication strategies. Retailers, public health officials, industry and other key stakeholders like- wise use an array of communications vehicles and sources. FDA’s com- munication strategy during emergencies must use all such media to reach these different audiences and ensure that potentially harmful products are removed promptly.

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0 ENHANCING FOOD SAFETY FDA will enhance its risk communication program through aggressive, tar- geted food safety campaigns that disseminate clear and effective messages and regular updates through multiple venues to all targeted audiences. This program’s designers will solicit input from the new FDA Risk Communica- tions Advisory Committee, which is tasked with obtaining expert advice in the field of risk communications. 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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 APPENDIX G VI. ENHANCE INFORMATION TECHNOLOGY In support of all three components of the Food Protection Plan, FDA plans to enhance its IT systems related to both domestic and imported foods. The focus will be to help the FDA more rapidly identify food importers, and maintain, update, and search records on food facilities and shipments more efficiently. In particular, FDA will enhance collaboration with CBP on IT systems to more accurately identify firms involved in the food import supply chain during the import screening and review processes. These systems will allow for analysis of historical risk data about firms when making entry decisions for the firms’ products. A new systems approach can eliminate many problems with our current data. For example, assigning a unique identifier will eliminate duplicate records and make risk data about a firm easier to access. Policies for requir- ing the use of the new single national identifier will need to be established and agreed upon, recognizing the impact on industry worldwide. Nearly all FDA business processes will benefit from more reliable and accu- rate information. Implementation of a new system will require a coordinated multi-agency effort that will benefit all federal agencies that process imported foods. CBP’s existing data and ongoing activity will play a key role. Finally, FDA will ensure that its infrastructure and disaster recovery system for IT systems and data are ready to deal with planned (maintenance and upgrades) and unplanned outages. This will provide the necessary support for import operations, which require the availability of multiple FDA sys- tems around the clock. As an example, shipments arrive at U.S. ports day and night, and Prior Notice data are submitted at all hours. IT systems provide screening of the data as they are submitted, and Prior Notice Center (PNC) staff work around the clock to review the risk presented by ship- ments before their arrival. The PNC needs to review shipment data in as little as two hours from submission. Any interruption in the availability of the computer systems prevents the filing and timely review of information. 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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 ENHANCING FOOD SAFETY VII. CONCLUSION Ensuring that FDA-regulated products are safe and secure is a vital part of FDA’s mission—to protect and promote public health. The FDA remains committed to working closely with its partners to protect the nation’s food supply. In the United States, market forces give companies a strong motivation to be vigilant and even innovative in ensuring food safety. The laws of regula- tion must encourage, not disrupt, these motivations. Rather than taking over responsibility from food companies, FDA wants to protect their flex- ibility to pursue it vigorously. Although we have made progress, much remains to be done. Recent inci- dents of contaminated food and animal feed have highlighted the impor- tance of a strong food protection system. Americans rightly expect to purchase food without having to worry about safety. Rising food imports, increasing consumption of convenience foods, and new foodborne pathogens are among the challenges we face. To address these challenges, we must move toward a food safety and defense system that is more proactive and strategic. FDA’s Food Protection Plan contains three core elements—prevention, inter- vention, and response—with greater emphasis on preventive measures that keep contaminated food from ever reaching consumers. 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. Department of Health and Human Services in September 2007. Both plans focus efforts on working smarter and better with importers, manufacturers, and other government agencies. FDA will aggressively pursue the Food Protection Plan so that U.S. consum- ers can be assured that their food remains among the safest in the world.

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 APPENDIX G Figure G-4 R01720 color, portrait size uneditable bitmapped image

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