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• Reportable Food Registry for Industry

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  "The Reportable Food Registry (RFR or the Registry) is an electronic portal for Industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. The Registry helps the FDA better protect public health by tracking patterns and targeting inspections. The Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085), section 1005 directs the FDA to establish a Reportable Food Registry for Industry. The RFR applies to all FDA-regulated categories of food and feed, except dietary supplements and infant formula."

  United States. Food and Drug Administration

  2010
• Zika Virus Vaccines and Therapeutics

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  This is a 45-minute presentation on the Zika virus. "Zika virus is a rapidly emerging infectious disease of great public health importance. Although infections are frequently asymptomatic or mildly symptomatic, associations with severe neurologic complications in infants born to mothers infected with Zika virus during pregnancy as well as neurologic complications in adults (e.g., Guillan Barre Syndrome) have made Zika virus a high priority pathogen. At the time of the lecture, there were no licensed vaccines or therapeutics against Zika virus; however, there were numerous vaccine candidates in development. The anti-Zika virus vaccine candidates in the pipeline as well as ongoing efforts to identify therapeutics effective against this pathogen were discussed."

  United States. Food and Drug Administration

  McArthur, Monica

  2017-04-13
• Fact Sheet for Health Care Providers: Interpreting Idylla (TM) Ebola Virus Triage Test Results

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  Taken from the Disaster Information Management Research Center's Annotation: "This three-page document provides information about the Emergency Use Authorization (EUA) issued to authorize the use of the Biocartis Idylla (TM) Ebola Virus Triage Test with the Biocartis Idylla (TM) Instrument System to test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in EDTA [Ethylenediaminetetraacetic Acid] venous whole blood specimens obtained from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors."

  United States. Food and Drug Administration

  2016-05-26
• FDA's Role in Medical Device Cybersecurity: Dispelling Myths and Understanding Facts

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  "As medical devices become more digitally interconnected and interoperable, they can improve the care patients receive and create efficiencies in the health care system. Medical devices, like computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. By carefully considering possible cybersecurity risks while designing medical devices, and having a plan to manage emerging cybersecurity risks, manufacturers can reduce cybersecurity risks posed to devices and patients. The FDA has published premarket and postmarket guidances that offer recommendations for comprehensive management of medical device cybersecurity risks, continuous improvement throughout the total product life-cycle, and incentivize changing marketed and distributed medical devices to reduce risk. Even with these guidances, the FDA continues to address myths about medical device cybersecurity."

  United States. Food and Drug Administration
• Food Protection Plan: One-Year Progress Summary

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  "The [Food Protection Plan (FPP)] One-Year Progress Summary identifies FDA's current food safety goals as well as recent accomplishments toward realizing the complete vision and strategies outlined in the FPP. The FPP program will continue to evolve based on the Agency's understanding of effective prevention practices, successful intervention methods at key points in the food production system, and enhanced emergency capabilities so that the Agency working with its partners can respond immediately when problems are identified. The FDA is committed to sustaining and growing a food protection framework that keeps the American food supply safe."

  United States. Food and Drug Administration

  2008-12
• U.S. Food and Drug Administration (FDA) [website]

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  This website is the main page for the U.S. Food and Drug Administration (FDA). It includes pages for topics such as food, drugs, medical devices, vaccines, blood & biologics, animal & veterinary, cosmetics, radiation-emitting products, and combination products. "The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health."

  United States. Food and Drug Administration
• FDA's Strategic Plan for Risk Communication

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  "The purpose of this document is to describe the U.S. Food and Drug Administration's strategy for improving how the agency communicates about regulated products. The strategy is intended to guide program development and research planning in a dynamic environment where rapidly evolving technologies enable patients and consumers to become increasingly involved in managing their health and well-being. We define three key areas-science, capacity, and policy-in which strategic actions can help improve how we communicate about the risks and benefits of regulated products, as well as how we oversee communications produced by regulated entities. The box titled FDA Risk Communication Strategic Plan at a Glance summarizes the three key areas and the associated strategies on which we will focus our efforts. This FDA Strategic Plan for Risk Communication is an ambitious one that will take time and substantial collaboration with stakeholders to implement. However, FDA is confident this strategy will help ensure that FDA-regulated products are used appropriately, a goal critical to the agency's mission of protecting and promoting the public health."

  United States. Food and Drug Administration

  2009
• U.S. Food and Drug Administration: The Center for Veterinary Medicine and Counterterrorism

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  The U.S. FDA provides a listing of links related to countering bioterrorism. Link categories include general topics, FAQs, public health initiatives/actions/preparedness, and specific types of biological agents such as anthrax and smallpox. Furthermore,"The Center for Veterinary Medicine (CVM) is working with other federal agencies to help the country prepare for a biological emergency, natural disaster or terrorist attack by making sure there is a safe and adequate supply of animal drug products and a safe animal feed supply system. This page contains information on CVM's role in counterterrorism."

  United States. Food and Drug Administration
• Food and Drug Administration's Strategic Action Plan: Protecting and Advancing America's Health: Responding to New Challenges and Opportunities

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  The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. This Strategic Action Plan outlines the following goals: Use science-based efficient risk management in all Agency regulatory activities, so that the Agency's limited resources can provide the most health promotion and protection at the least cost for the public; Enable consumers to make smarter decisions by getting them better information to weigh the benefits and risks of FDA-regulated products; Seek continuous improvements in patient and consumer safety by reducing risks associated with FDA-regulated products; Strengthen FDA's capability to identify, prepare for, and respond to terrorist threats and incidents; Ensure a world-class professional workforce, effective and efficient operations, and adequate resources to accomplish the agency's mission.

  United States. Food and Drug Administration

  2003-08
• FDA Issues Final Two Proposed Food Safety Regulations

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  FDA today announced publication of the final two food safety proposed regulations required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("The Act"), which gave FDA new authority to protect the nation's food supply. The proposals are two of four proposed regulations that the Act calls upon FDA to develop regarding food safety. These two proposals deal with establishing and maintaining records among food firms, and the administrative detention of foods that may pose a risk to public health. The other two proposals, concerning the registration of food facilities and prior notice of imported foods, were published in January 2003.

  United States. Food and Drug Administration

  2003-05-06
• Progress Report to Secretary Tommy G. Thompson: Ensuring the Safety and Security of the Nation's Food Supply

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  This document summarizes the role played by FDA in combating the terrorist threat to foods. The events of September 11, 2001, heightened the nation's awareness and placed a renewed focus on ensuring the protection of the nation's critical infrastructures. A terrorist attack on the food supply could pose both severe public health and economic impacts, while damaging the public's confidence in the food we eat. FDA thorough it's aggressive program, has made significant progress in strengthening the safety and security of the Nation's food supply. This progress has been achieved through the application of FDA's 10-step program which focuses on a stronger FDA, a strategic approach to screening food imports, issuing rules in accordance with Bioterrorism Act Regulations, issuing new industry guidance documents, conducting vulnerability and threat assessments of the nation's food supply, ramping up targeted surveillance of both domestic and imported food under Operation Liberty Shield, establishing the Office of Crisis Management, making laboratory enhancements, pursuing research on the development of prevention and mitigation technologies and strategies, and interagency communication and collaboration.

  United States. Food and Drug Administration

  2003-07-23
• Summary: Ensuring the Safety and Security of the Nation's Food Supply: Progress Report to Secretary Tommy G.Thompson

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  This document provides a brief summary of FDA's progress report submitted to the Department of Health and Human Services. The document outlines the 10-Point Program established by the FDA to implement a comprehensive approach for awareness of, prevention of, preparedness for, response to, and recovery from foodborne terrorist attacks.

  United States. Food and Drug Administration

  2003-07-23
• Radiation Safety: Questions about Food Safety: Questions about Medical Products

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  This U.S. Food and Drug Administration (FDA) document addresses questions about radiation safety in relation to food safety and medical products. Questions answered include: "What is FDA doing to assess the situation in Japan?" "What systems does FDA have in place to protect the U.S. food supply?" "What products come to the U.S. from Japan?" "Are there dairy products that come from Japan?" "Are there food harvesting (fields, fisheries) or processing facilities in the area of the Fukushima nuclear reactor?" "Is there any reason for concern about radiation from these products when they are imported into the U.S.?" "What are the current procedures for measuring radiation contamination in food and how will these change?" "How will FDA ensure consumers' safety?" "Will FDA issue an import bulletin and what sort of techniques will FDA use to measure radiation in food?" "Is FDA looking at products that might have traveled through Japan at the time of the explosion?" "How will the radiation affect fish and seafood that have not yet been fished or harvested?" "What are the chances of radiation affecting growing areas in the US?" "What action will FDA take to ensure the safety of consumers of those products?" Questions about medical products include: "Hypothetically, if they were needed, what are the FDA-approved products for radiation exposure?" "Is potassium iodide the only medication available for radiation exposure?" "We have heard that potassium iodide is in short supply, is that correct?" "Does FDA recommend that consumers purchase potassium iodide as a protective step?" "With exports from Japan disrupted, is there any possibility that some medical products could be in short supply?" "If I see web sites advertising potassium iodide or alternative cures, should I buy the products?"

  United States. Food and Drug Administration

  2011-03-17
• Order Permitting Emergency Dispensing of Oral Formulations of Doxycycline and Waiver of CGMP Requirements During an Anthrax Emergency

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  From the Document: "[T]he Food and Drug Administration (FDA) is hereby issuing this order to permit emergency dispensing of FDA-approved oral dosage forms of doxycycline products ('eligible doxycycline products') for the post-exposure prophylaxis (PEP) of inhalational anthrax during an emergency involving 'Bacillus anthracis (B. anthracis)', the biological agent that causes anthrax disease. Although there is not currently an active emergency involving 'B. anthracis' ('anthrax emergency'), this order will allow stakeholders to implement plans for emergency dispensing of eligible doxycycline products without individual prescriptions in the future if they reasonably believe there is a need to do so because of their constituents' known, suspected, or likely imminent exposure to 'B. anthracis'."

  United States. Food and Drug Administration

  Borio, Luciana

  2016-04-13
• Order Permitting Emergency Dispensing of Oral Formulations of Ciprofloxacin and Waiver of CGMP Requirements During an Anthrax Emergency

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  From the Document: "[T]he Food and Drug Administration (FDA) is hereby issuing this order to permit emergency dispensing of FDA-approved oral dosage forms of ciprofloxacin products ('eligible ciprofloxacin products') for the post-exposure prophylaxis (PEP) of inhalational anthrax during an emergency involving 'Bacillus anthracis (B. anthracis)', the biological agent that causes anthrax disease. Although there is not currently an active emergency involving 'B. anthracis' ('anthrax emergency'), this order will allow stakeholders to implement plans for emergency dispensing of eligible ciprofloxacin products without individual prescriptions in the future if they reasonably believe there is a need to do so because of their constituents' known, suspected, or likely imminent exposure to 'B. anthracis'."

  United States. Food and Drug Administration

  Borio, Luciana

  2016-04-13
• Radiation-Emitting Products: Response to University of California - San Francisco Regarding Their Letter of Concern, October 12, 2010

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  This letter, from Deputy Director for Technical and Radiological Initiatives John L. McCrohan and Deputy Assistant Administrator/Chief Administrative Officer Karen R. Shelton Waters to Assistant to the President for Science and Technology John P. Holdren, responds to an April 6, 2010 letter "regarding general-use full-body x-ray screening systems used for airport security. As with all x-ray security products, justified application demands a balancing act: The radiation dose delivered must be sufficient to do the job--in this case to identify security threats--while presenting no more than a miniscule risk to people being scanned, including special populations."

  United States. Food and Drug Administration

  2010-10-12
• Food Protection Plan 2007

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  "American consumers enjoy one of the safest food supplies in the world; however, we know it can be made even safer. FDA [United States. Food and Drug Administration] regulates $417 billion worth of domestic food and $49 billion worth of imported food each year--everything we eat except for meat, poultry, and some egg products, which are regulated by the U.S. Department of Agriculture. FDA has developed a comprehensive Food Protection Plan to address the changes in food sources, production, and consumption that we face in today's world. Building upon and improving an already sound food safety protection capability, the new plan presents a robust strategy to protect the nation's food supply from both unintentional contamination and deliberate attack. FDA's Food Protection Plan builds in prevention first, then intervention, and finally, response. This new strategy will help ensure that Americans continue to benefit from one of the safest food supplies in the world." Specific topics covered, include: "FDA Food Protection Plan One-Year Progress Summary"; "FDA Food Protection Plan Six-Month Progress Summary"; "Fact Sheet: Food Protection Plan"; "Food Protection Plan"; "Gateway to Food Protection Meeting"; "Photos Highlighting FDA's Food Protection Efforts"; and "Questions and Answers: Food Protection Plan".

  United States. Food and Drug Administration

  2009
• Strategic Priorities 2011-2015: Responding to the Public Health Challenges of the 21st Century

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  This plan presents the Food and Drug Administration's (FDA) priorities from 2011 through 2015. "FDA's primary responsibility is to protect the American people from unsafe or mislabeled food, drugs, and other medical products and to make sure consumers have access to accurate, science-based information about the products they need and rely on every day. The agency also guides and oversees the development and availability of effective new medical products and new food products that harness the latest advances in science and technology to improve the health and well-being of American consumers. [...] The purpose of this document is to outline FDA's strategic intentions and plans for the next five years (2011 - 2015). This document is intended to communicate the Commissioner's key priorities, including cross-cutting strategic priorities, program-specific strategic goals, and long-term objectives. These goals and objectives provide the vehicle for focusing agency efforts to achieve FDA's public health mission and to fulfill our role in supporting the larger mission and strategic goals of [the Department of Health and Human Services]." In supporting the aforementioned mission, the FDA's long-term objective is to "increase the nation's preparedness to address threats as a result of bioterrorism, pandemic and emerging infectious diseases."

  United States. Food and Drug Administration
• Emergency Use Authorization of Medical Products Guidance - Emergency Use Authorization of Medical Products

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  "This guidance explains FDA's [Food and Drug Administration] policies for authorizing the emergency use of medical products under section 564 of the Federal Food, Drug, and Cosmetic Act.... Section 564 permits the FDA Commissioner to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security. The Emergency Use Authorization (EUA) authority recently granted by Congress allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological, and nuclear agents that may be used to attack the American people or the U.S. armed forces. Under section 564, the FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved, and available alternatives. The document is intended to inform industry, government agencies, and FDA staff of the Agency's general recommendations and procedures for issuance of EUAs.3 FDA expects that requests for consideration for an EUA would be submitted by government agencies (e.g., the Department of Health and Human Services or the Department of Defense (DoD)) or private entities. FDA may seek additional data and information on a case-by-case basis to ensure that the statutory criteria for issuance of an EUA are met."

  United States. Food and Drug Administration

  2007-07
• Pathway to Global Product Safety and Quality

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  "We live in a nation that increasingly relies on other countries to produce the food, drugs, cosmetics, and devices we use in our daily lives. Between 10% and 15% of all food consumed by United States (U.S.) households is imported from abroad. Nearly two-thirds of the fruits and vegetables--and 80% of seafood--eaten domestically come from outside the U.S. Half of all medical devices used in this country are imported, while 80 percent of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere. […] Globalization has fundamentally altered the economic and security landscape and demands a major change in the way FDA fulfills its mission to promote and protect the 2 health of the American people. Just as public health leaders have long recognized that disease knows no borders, FDA in crafting its vision for the next decade knows that product safety and quality no longer begin or end at the border. This rapidly changing environment, and a desire to move from a posture of intercepting harmful products to anticipating and preventing the arrival of such goods, has prompted FDA leadership to develop this 'Pathway to Global Product Safety and Quality.'"

  United States. Food and Drug Administration

  2011-06
• Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables: Draft Final Guidance

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  "This guidance is intended for all fresh-cut produce processing firms, both domestic firms and firms importing or offering fresh-cut product for import into the U.S., to enhance the safety of fresh-cut produce by minimizing the microbial food safety hazards. This guidance does not set binding requirements or identify all possible preventive measures to minimize microbial food safety hazards. We recommend that each fresh-cut produce processor assess the recommendations in this guidance and then tailor its food safety practices to the processor's particular operation. Alternative approaches that minimize microbial food safety hazards may be used so long as they are consistent with applicable laws and regulations. This guidance primarily addresses microbiological hazards and appropriate control measures for such hazards. However, some chapters in the guidance discuss physical and chemical hazards. FDA's guidance documents, including this document, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required."

  United States. Food and Drug Administration

  2007-03
• FDA Strategic Partnership Program Agroterrorism (SPPA) Initiative: First Year Status Report, September 2005 - June 2006

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  "To assist in protecting the nation's food supply, the Federal Bureau of Investigation (FBI), Department of Homeland Security (DHS), U.S. Department of Agriculture (USDA), and the Food and Drug Administration (FDA) have developed a joint assessment program, the Strategic Partnership Program Agroterrorism (SPPA) Initiative. The purpose of this initiative is to conduct a series of assessments of the food and agricultural sector in collaboration with private industry and State volunteers. These assessments support the requirements for a coordinated food and agriculture infrastructure protection program as stated in the National Infrastructure Protection Plan (NIPP), Sector Specific Plans (SSP), and Homeland Security Presidential Directive 9 (HSPD-9), Defense of US Agriculture and Food. SPPA assessments are conducted on a voluntary basis between one or more industry representatives for a particular product or commodity, their trade association(s), and Federal and State Government agricultural, public health and law enforcement officials. Together, they conduct a vulnerability assessment of that industry's production process using the CARVER + Shock tool. The acronym 'CARVER' stands for the factors assessed: Criticality, Accessibility, Recuperability, Vulnerability, Effect, Recognizability, and Shock. As a result of each assessment, participants identified nodes or process points of highest concern, protective measures and mitigation steps that may reduce the vulnerability of these nodes, and research gaps/needs. Discussions of mitigation steps and best practices were general in nature, focusing on physical security improvements for food processing facilities and biosecurity practices and disease surveillance for livestock."

  United States. Food and Drug Administration

  2006-06
• Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance

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  "This guidance is designed as an aid to operators of retail food stores and food service establishments (for example, bakeries, bars, bed-and-breakfast operations, cafeterias, camps, child and adult day care providers, church kitchens, commissaries, community fund raisers, convenience stores, fairs, food banks, grocery stores, interstate conveyances, meal services for home-bound persons, mobile food carts, restaurants, and vending machine operators). This is a very diverse set of establishments, which includes both very large and very small entities. This guidance identifies the kinds of preventive measures they may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal, or terrorist actions. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. Operators of food retail food stores and food service establishments are encouraged to review their current procedures and controls in light of the potential for tampering or other malicious, criminal, or terrorist actions and make appropriate improvements. This guidance is designed to focus operators' attention sequentially on each segment of the food delivery system that is within their control, to minimize the risk of tampering or other malicious, criminal, or terrorist action at each segment. To be successful, implementing enhanced preventive measures requires the commitment of management and staff."

  United States. Food and Drug Administration

  2007-10
• FDA and the Fight against Terrorism

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  "Minutes after two hijacked airliners crashed into the World Trade Center on the morning of Sept.11, 2001, the Federal Aviation Administration stopped all flights from U.S. airports. It marked the first time that air traffic came to a halt nationwide. Soon after, a third plane crashed into the Pentagon, and a fourth plane thought to be headed for another target in Washington, D.C., crashed into a field in Somerset County, Pa. All told, more than 3,000 people died. Experts from the Food and Drug Administration immediately became involved. They ensured that blood could be collected quickly from people living near the disaster sites to help the injured survivors. Other agency experts evaluated burn wound dressings that could be used to treat victims and checked on reserves of drugs and medical supplies. And while the country was still reeling from these tragedies, terrorists launched more attacks through the mail in October 2001. Letters containing anthrax spores (Bacillus anthracis) were mailed to U.S. senators and members of the media. The Centers for Disease Control and Prevention (CDC) recorded 22 cases of anthrax. There were 11 cases of cutaneous (skin-based) anthrax and 11 cases of inhalational anthrax. Among the inhalational cases, there were five deaths. A key challenge for public health workers was the fact that early inhalational anthrax symptoms are similar to those of common illnesses such as the flu. Lung infections with anthrax can rapidly become fatal unless appropriate antibiotic treatment is started very soon after symptoms develop." This report investigates FDA strategies for counterterrorism, and places the response of the FDA to threats into context of past attacks and present-day capabilities.

  United States. Food and Drug Administration

  Meadows, Michelle

  2004-01
• Food Tampering: An Extra Ounce of Caution

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  "In todays world, were all being more cautious as we go about our daily routines. And, this caution should also extend to the care we take when we shop for and prepare foods. The deliberate tampering of food to cause major disease outbreaks is rare, particularly in the United States. However, recent news events have focused attention on the increasing possibility of such tampering. As a result, the Food and Drug Administration (FDA) is enhancing its surveillance of foodborne disease and increasing the inspection of domestic and foreign food processing plants. The food industry is also stepping up safety measures to ensure that its products are produced as safely as possible." This report investigates many of the warnings involving food tampering within the United States, as well as best practices to keeping others safe in cases of contamination.

  United States. Food and Drug Administration

  2004
• FDA Offers Tips about Medical Devices and Hurricane Disasters

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  This document provides guidance on using medical devices during hurricanes. The tip sheet covers topics such as general safety, power outages, heat and humidity, water contamination, and sterility.

  United States. Food and Drug Administration

  2008-08-29?
• Salmonella: Saintpaul Outbreak Traceback and Distribution

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  This chart provides a partial view of the traceback and distribution of peppers that are believed to have caused the salmonella outbreak in July 2008.

  United States. Food and Drug Administration

  2008-07-30
• Enforcement Strategy Update (of) FDA Regulation 21 CFR 589.2000, The BSE Feed Regulation

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  This document describes the efforts in accomplishments in conforming to the Regulation to ensure the prevention of the spread of BSE, further goals in this effort and identifies resources needed to meet these goals.

  United States. Food and Drug Administration

  1998-12
• Consumer's Guide to Food Safety: Severe Storms and Hurricanes

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  This page from the Food Safety Inspection Service provides information on food safety during an emergency resulting from severe storms or hurricanes. "Did you know that a flood, fire, national disaster, or the loss of power from high winds, snow, or ice could jeopardize the safety of your food? Knowing how to determine if food is safe and how to keep food safe will help minimize the potential loss of food and reduce the risk of foodborne illness. This Consumer's Guide will help you make the right decisions for keeping your family safe during an emergency."

  United States. Food and Drug Administration
• U.S. Food and Drug Administration: Foods [website]

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  This is the Food and Drug Administration [FDA] Foods website. It provides links to news, safety programs, programs, and areas of special interests as it relates to food safety.

  United States. Food and Drug Administration