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| fda food fraud vulnerability assessment tool: Food Fraud Rosalee S. Hellberg, Karen Everstine, Steven A. Sklare, 2020-11-30 Food Fraud: A Global Threat With Public Health and Economic Consequences serves as a practical resource on the topic of food fraud prevention and compliance with regulatory and industry standards. It includes a brief overview of the history of food fraud, current challenges, and vulnerabilities faced by the food industry, and requirements for compliance with regulatory and industry standards on mitigating vulnerability to food fraud, with a focus on the Global Food Safety Initiative (GFSI) Benchmarking Requirements. The book also provides individual chapters dedicated to specific commodities or sectors of the food industry known to be affected by fraud, with a focus on specific vulnerabilities to fraud, the main types of fraud committed, analytical methods for detection, and strategies for mitigation. The book provides an overview of food fraud mitigation strategies applicable to the food industry and guidance on how to start the process of mitigating the vulnerability to food fraud. The intended audience for this book includes food industry members, food safety and quality assurance practitioners, food science researchers and professors, students, and members of regulatory agencies. - Presents industry and regulatory standards for mitigating vulnerability to food fraud including Global Food Safety Initiative (GFSI) Benchmarking Requirements - Provides tools and resources to comply with industry and regulatory standards, including steps for developing a food fraud vulnerability assessment and mitigation plan - Contains detailed, commodity-specific information on the major targets of food fraud, including specific vulnerabilities to fraud, analytical methods, and strategies for mitigation |
| fda food fraud vulnerability assessment tool: Food Fraud Prevention John W. Spink, 2019-10-18 This textbook provides both the theoretical and concrete foundations needed to fully develop, implement, and manage a Food Fraud Prevention Strategy. The scope of focus includes all types of fraud (from adulterant-substances to stolen goods to counterfeits) and all types of products (from ingredients through to finished goods at retail). There are now broad, harmonized, and thorough regulatory and standard certification requirements for the food manufacturers, suppliers, and retailers. These requirements create a need for a more focused and systematic approach to understanding the root cause, conducting vulnerability assessments, and organizing and implementing a Food Fraud Prevention Strategy. A major step in the harmonizing and sharing of best practices was the 2018 industry-wide standards and certification requirements in the Global Food Safety Initiative (GFSI) endorsed Food Safety Management Systems (e.g., BRC, FSSC, IFS, & SQF). Addressing food fraud is now NOT optional – requirements include implementing a Food Fraud Vulnerability Assessment and a Food Fraud Prevention Strategy for all types of fraud and for all products. The overall prevention strategy presented in this book begins with the basic requirements and expands through the criminology root cause analysis to the final resource-allocation decision-making based on the COSO principle of Enterprise Risk Management/ ERM. The focus on the root cause expands from detection and catching bad guys to the application of foundational criminology concepts that reduce the overall vulnerability. The concepts are integrated into a fully integrated and inter-connected management system that utilizes the Food Fraud Prevention Cycle (FFPC) that starts with a pre-filter or Food Fraud Initial Screening (FFIS). This is a comprehensive and all-encompassing textbook that takes an interdisciplinary approach to the most basic and most challenging questions of how to start, what to do, how much is enough, and how to measure success. |
| fda food fraud vulnerability assessment tool: Fish and Fishery Products Barry Leonard, 2011-08 This guidance will assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors of fish and fishery products will find info. that will help them identify hazards that are associated with their products, and help them formulate control strategies. It will help consumers understand commercial seafood safety in terms of hazards and their controls. It does not specifically address safe handling practices by consumers or by retail estab., although the concepts contained in this guidance are applicable to both. This guidance will serve as a tool to be used by fed. and state regulatory officials in the evaluation of HACCP plans for fish and fishery products. Illustrations. This is a print on demand report. |
| fda food fraud vulnerability assessment tool: Food Safety for the 21st Century Carol A. Wallace, William H. Sperber, Sara E. Mortimore, 2018-08-08 Revised to reflect the most recent developments in food safety, the second edition of Food Safety for the 21st Century offers practitioners an authoritative text that contains the essentials of food safety management in the global supply chain. The authors — noted experts in the field — reveal how to design, implement and maintain a stellar food safety programme. The book contains industry best-practices that can help businesses to improve their systems and accelerate the application of world-class food safety systems. The authors outline the key food safety considerations for individuals, businesses and organisations involved in today’s complex global food supply chains. The text contains the information needed to recognise food safety hazards, design safe products and processes and identify and manage effectively the necessary control mechanisms within the food business. The authors also include a detailed discussion of current issues and key challenges in the global food supply chain. This important guide: • Offers a thorough review of the various aspects of food safety and considers how to put in place an excellent food safety system • Contains the information on HACCP appropriate for all practitioners in the world-wide food supply chain • Assists new and existing business to meet their food safety goals and responsibilities • Includes illustrative examples of current thinking and challenges to food safety management and recommendations for making improvements to systems and practices Written for food safety managers, researchers and regulators worldwide, this revised guide offers a comprehensive text and an excellent reference for developing, implementing and maintaining world-class food safety programmes and shows how to protect and defend the food supply chain from threats. |
| fda food fraud vulnerability assessment tool: Pain Management and the Opioid Epidemic National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse, 2017-09-28 Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring. |
| fda food fraud vulnerability assessment tool: Food Safety Handbook International Finance Corporation, 2020-07-06 The Food Safety Handbook: A Practical Guide for Building a Robust Food Safety Management System, contains detailed information on food safety systems and what large and small food industry companies can do to establish, maintain, and enhance food safety in their operations. This new edition updates the guidelines and regulations since the previous 2016 edition, drawing on best practices and the knowledge IFC has gained in supporting food business operators around the world. The Food Safety Handbook is indispensable for all food business operators -- anywhere along the food production and processing value chain -- who want to develop a new food safety system or strengthen an existing one. |
| fda food fraud vulnerability assessment tool: Encyclopedia of Food Chemistry , 2018-11-22 Encyclopedia of Food Chemistry, Three Volume Set is the ideal primer for food scientists, researchers, students and young professionals who want to acquaint themselves with food chemistry. Well-organized, clearly written, and abundantly referenced, the book provides a foundation for readers to understand the principles, concepts, and techniques used in food chemistry applications. Articles are written by international experts and cover a wide range of topics, including food chemistry, food components and their interactions, properties (flavor, aroma, texture) the structure of food, functional foods, processing, storage, nanoparticles for food use, antioxidants, the Maillard and Strecker reactions, process derived contaminants, and the detection of economically-motivated food adulteration. The encyclopedia will provide readers with an introduction to specific topics within the wider context of food chemistry, as well as helping them identify the links between the various sub-topics. Offers readers a comprehensive understanding of food chemistry and the various connections between the sub-topics Provides an authoritative introduction for non-specialists and readers from undergraduate levels and upwards Meticulously organized, with articles structured logically based on the various elements of food chemistry |
| fda food fraud vulnerability assessment tool: Comprehensive Foodomics , 2020-11-12 Comprehensive Foodomics, Three Volume Set offers a definitive collection of over 150 articles that provide researchers with innovative answers to crucial questions relating to food quality, safety and its vital and complex links to our health. Topics covered include transcriptomics, proteomics, metabolomics, genomics, green foodomics, epigenetics and noncoding RNA, food safety, food bioactivity and health, food quality and traceability, data treatment and systems biology. Logically structured into 10 focused sections, each article is authored by world leading scientists who cover the whole breadth of Omics and related technologies, including the latest advances and applications. By bringing all this information together in an easily navigable reference, food scientists and nutritionists in both academia and industry will find it the perfect, modern day compendium for frequent reference. List of sections and Section Editors: Genomics - Olivia McAuliffe, Dept of Food Biosciences, Moorepark, Fermoy, Co. Cork, Ireland Epigenetics & Noncoding RNA - Juan Cui, Department of Computer Science & Engineering, University of Nebraska-Lincoln, Lincoln, NE Transcriptomics - Robert Henry, Queensland Alliance for Agriculture and Food Innovation, The University of Queensland, St Lucia, Australia Proteomics - Jens Brockmeyer, Institute of Biochemistry and Technical Biochemistry, University Stuttgart, Germany Metabolomics - Philippe Schmitt-Kopplin, Research Unit Analytical BioGeoChemistry, Neuherberg, Germany Omics data treatment, System Biology and Foodomics - Carlos Leon Canseco, Visiting Professor, Biomedical Engineering, Universidad Carlos III de Madrid Green Foodomics - Elena Ibanez, Foodomics Lab, CIAL, CSIC, Madrid, Spain Food safety and Foodomics - Djuro Josic, Professor Medicine (Research) Warren Alpert Medical School, Brown University, Providence, RI, USA & Sandra Kraljevic Pavelic, University of Rijeka, Department of Biotechnology, Rijeka, Croatia Food Quality, Traceability and Foodomics - Daniel Cozzolino, Centre for Nutrition and Food Sciences, The University of Queensland, Queensland, Australia Food Bioactivity, Health and Foodomics - Miguel Herrero, Department of Bioactivity and Food Analysis, Foodomics Lab, CIAL, CSIC, Madrid, Spain Brings all relevant foodomics information together in one place, offering readers a ‘one-stop,’ comprehensive resource for access to a wealth of information Includes articles written by academics and practitioners from various fields and regions Provides an ideal resource for students, researchers and professionals who need to find relevant information quickly and easily Includes content from high quality authors from across the globe |
| fda food fraud vulnerability assessment tool: Food Protection and Security Shaun Kennedy, 2016-10-26 Food Protection and Security: Preventing and Mitigating Intentional and Unintentional Contamination of Food and Beverage presents the latest information on our need to protect our food supply from accidental contamination, economically motivated adulteration, and contamination with intent to harm (bioterrorism or agro-terrorism). This book covers all three branches of food protection, providing a comprehensive overview of the methods and strategy involved. Part one covers the need for food protection, looking at potential hazards in the production, processing, and supply chain. Part two looks at detection methods for contaminants in food, with the final section addressing food contamination incidents and prevention and response strategies. - Explores the need for food protection, from natural disasters to contamination in food processing facilities - Examines techniques used to detect contaminants in food, such as microbiological testing and fingerprinting - Provides key ways to address food contamination issues |
| fda food fraud vulnerability assessment tool: Food Safety Handbook Ronald H. Schmidt, Gary E. Rodrick, 2005-03-11 As with the beginning of the twentieth century, when food safety standards and the therapeutic benefits of certain foods and supplements first caught the public’s attention, the dawn of the twenty-first century finds a great social priority placed on the science of food safety. Ronald Schmidt and Gary Rodrick’s Food Safety Handbook provides a single, comprehensive reference on all major food safety issues. This expansive volume covers current United States and international regulatory information, food safety in biotechnology, myriad food hazards, food safety surveillance, and risk prevention. Approaching food safety from retail, commercial, and institutional angles, this authoritative resource analyzes every step of the food production process, from processing and packaging to handling and distribution. The Handbook categorizes and defines real and perceived safety issues surrounding food, providing scientifically non-biased perspectives on issues for professional and general readers. Each part is divided into chapters, which are then organized into the following structure: Introduction and Definition of Issues; Background and Historical Significance; Scientific Basis and Implications; Regulatory, Industrial, and International Implications; and Current and Future Implications. Topics covered include: Risk assessment and epidemiology Biological, chemical, and physical hazards Control systems and intervention strategies for reducing risk or preventing food hazards, such as Hazard Analysis Critical Control Point (HACCP) Diet, health, and safety issues, with emphasis on food fortification, dietary supplements, and functional foods Worldwide food safety issues, including European Union perspectives on genetic modification Food and beverage processors, manufacturers, transporters, and government regulators will find the Food Safety Handbook to be the premier reference in its field. |
| fda food fraud vulnerability assessment tool: Scientific Criteria to Ensure Safe Food National Research Council, Institute of Medicine, Division on Earth and Life Studies, Board on Agriculture and Natural Resources, Food and Nutrition Board, Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food, 2003-09-29 Food safety regulators face a daunting task: crafting food safety performance standards and systems that continue in the tradition of using the best available science to protect the health of the American public, while working within an increasingly antiquated and fragmented regulatory framework. Current food safety standards have been set over a period of years and under diverse circumstances, based on a host of scientific, legal, and practical constraints. Scientific Criteria to Ensure Safe Food lays the groundwork for creating new regulations that are consistent, reliable, and ensure the best protection for the health of American consumers. This book addresses the biggest concerns in food safetyâ€including microbial disease surveillance plans, tools for establishing food safety criteria, and issues specific to meat, dairy, poultry, seafood, and produce. It provides a candid analysis of the problems with the current system, and outlines the major components of the task at hand: creating workable, streamlined food safety standards and practices. |
| fda food fraud vulnerability assessment tool: Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies Institute of Medicine, Food Forum, 1999-04-29 The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop. |
| fda food fraud vulnerability assessment tool: Food Industry 4.0 Abdo Hassoun, 2024-04-15 Developments in Food Quality and Safety Series is the most up-to-date resource covering trend topics such as Advances in the analysis of toxic compounds and control of food poisoning; Food fraud, traceability and authenticity; Revalorization of agrifood industry; Natural antimicrobial compounds and application to improve the preservation of food; Non-thermal processing technologies in the food industry; Nanotechnology in food production; and Intelligent packaging and sensors for food applications. Volume 4, Food Industry 4.0: Emerging Trends and Technologies in Food Production and Consumption covers several technologies (e.g., robotics, smart sensors, artificial intelligence, and big data) at different development and research levels in order to provide holistic multidisciplinary approaches that embrace simultaneously as many Industry 4.0 technologies as possible, reflecting the long journey of food from farm (or sea) to fork. Chapters explore automation, digitalization, and green technologies, besides food quality, food safety food traceability, processing and preservation 4.0. Topics such as smart sensors, artificial intelligence and big data revolution, additive manufacturing, and emerging food trends are also explored. The series is edited by Dr. José Manuel Lorenzo and authored by a team of global experts in the fields of Food Quality and Safety, providing comprehensive knowledge to food industry personals and scientists. - Provides a comprehensive view of Industry 4.0 technologies as applied to the food industry - Covers the most trend topics related to novel foods in the light of emerging innovations and developments - Discusses how implementing innovative technologies holds significant potential to increase efficiency and value added, save time and cost, and increase profitability in various food sectors |
| fda food fraud vulnerability assessment tool: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients. |
| fda food fraud vulnerability assessment tool: TACCP - Threat Assessment and Critical Control Point Richard Leathers, 2015-08 |
| fda food fraud vulnerability assessment tool: Present Knowledge in Food Safety Michael E. Knowles, Lucia Anelich, Alan Boobis, Bert Popping, 2022-10-08 Present Knowledge in Food Safety: A Risk-Based Approach Through the Food Chain presents approaches for exposure-led risk assessment and the management of changes in the chemical, pathogenic microbiological and physical (radioactivity) contamination of 'food' at all key stages of production, from farm to consumption. This single volume resource introduces scientific advances at all stages of the production to improve reliability, predictability and relevance of food safety assessments for the protection of public health. This book is aimed at a diverse audience, including graduate and post-graduate students in food science, toxicology, microbiology, medicine, public health, and related fields. The book's reach also includes government agencies, industrial scientists, and policymakers involved in food risk analysis. - Includes new technologies such as nanotechnology, genetic modification, and cloning - Provides information on advances in pathogen risk assessment through novel and real-time molecular biological techniques, biomarkers, resistance measurement, and cell-to-cell communication in the gut - Covers the role of the microbiome and the use of surrogates (especially for viruses) |
| fda food fraud vulnerability assessment tool: Dairy Foods Adriano Gomes Da Cruz, Chaminda Senaka Ranadheera, Filomena Nazzaro, Amir Mortazavian, 2021-09-22 Dairy Foods: Processing, Quality, and Analytical Techniques provides comprehensive knowledge on the different factors involved in the development and safety precautions behind dairy foods, including special references to both theoretical and practical aspects. The book presents relevant information about the quality of dairy foods, including raw milk quality, predictive microbiology and risk analysis, food defense and food fraud. In addition, it looks into environmental aspects and consumer perception and goes on to cover methods and practices to process dairy products and analytical techniques behind dairy product development. Techniques explored include time domain magnetic resonance, thermal analysis and chemometric methods. This will be a valuable resource for researchers and practitioners in the dairy industry, as well as students in dairy science courses. - Offers a comprehensive accounting on the latest analytical methods used in the dairy industry - Focuses on the processing of dairy foods, including emerging and novel dairy products with low sodium and sugar contents - Sourced from a team of editors with relevant expertise in dairy food processing |
| fda food fraud vulnerability assessment tool: Countering the Problem of Falsified and Substandard Drugs Institute of Medicine, Board on Global Health, Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, 2013-06-20 The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines. |
| fda food fraud vulnerability assessment tool: Department of Defense Dictionary of Military and Associated Terms United States. Joint Chiefs of Staff, 1979 |
| fda food fraud vulnerability assessment tool: Food Control and Biosecurity Alexandru Mihai Grumezescu, Alina Maria Holban, 2018-02-13 Food Control and Biosecurity, Volume Sixteen, the latest release in the Handbook of Food Bioengineering series, is an essential resource for anyone in the food industry who needs to understand safety and quality control to prevent or reduce the spread of foodborne diseases. The book covers information from exporter to transporter, importer and retailer, and offers valuable tools to measure food quality while also addressing government standards and regulations for food production, processing and consumption. The book presents cutting-edge methods for detecting hazardous compounds within foods, including carcinogenic chemicals. Other related topics addressing food insecurity and food defense are also discussed. - Identifies the latest import/export regulations related to food control and biosecurity - Provides detection and analysis methods to ensure a safe food supply - Presents risk assessment tools and prevention strategies for food safety and process control |
| fda food fraud vulnerability assessment tool: Medical Devices and the Public's Health Institute of Medicine, Board on Population Health and Public Health Practice, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, 2011-11-25 Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework. |
| fda food fraud vulnerability assessment tool: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy Mahmoud Aljurf, John A. Snowden, Patrick Hayden, Kim H. Orchard, Eoin McGrath, 2021-02-19 This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program. |
| fda food fraud vulnerability assessment tool: OECD Reviews of Regulatory Reform Risk and Regulatory Policy Improving the Governance of Risk OECD, 2010-04-09 This publication presents recent OECD papers on risk and regulatory policy. They offer measures for developing, or improving, coherent risk governance policies. |
| fda food fraud vulnerability assessment tool: FDA Investigations Operations Manual Food and Drug Administration, 2003 Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions. |
| fda food fraud vulnerability assessment tool: Trends in Fish Processing Technologies Daniela Borda, Anca I. Nicolau, Peter Raspor, 2017-10-30 The high market demand based on consumers’ trust in fish as a healthy and nutritious food resource made fish processing a very dynamic industry, spurring many innovations in processing and packaging methods. Trends in Fish Processing Technologies not only reflects what is currently new in fish processing but also points out where things are heading in this area. This book provides an overview of the modern technologies employed by the industry. It details the advances in fish processing, including high pressure processing (HPP), pulsed electric field (PEF) treatment and minimally heat processing combined with microwave (MW) and radio-frequency (RF). It provides references to food safety management systems and food safety & quality indicators for processed fish in order to achieve an adequate level of protection. Quality aspects and molecular methods for the assessment of fish and fish products integrity are introduced. Fish products reformulation trends based on sustainability principles that tackles the reduction of salt content and the use of natural antimicrobials are presented. Innovative packaging solutions for fish products are explored, detailing intelligent packaging with freshness and time-temperature indicators, applications of modified packaging atmosphere, antimicrobial bio-nanocomposite packaging materials and biodegradable edible films used as primary fish packaging. In addition to covering the current advancements in fish processing the book discusses fraud, adulteration, fair trade practices, traceability and the need for added value, clean and sustainable processing in the fish chain. |
| fda food fraud vulnerability assessment tool: Quality Systems in the Food Industry Marco Fiorino, Caterina Barone, Michele Barone, Marco Mason, Arpan Bhagat, 2019-06-05 This book explains the role of food-oriented (or ‘food-centric’) quality system standards in the modern food and beverage industry. It discusses food safety schemes based on the international norm ISO 9001 and the “Hazard Analysis and Critical Control Points” approach, and also introduces the new Global Standard for Food Safety (GSFS) and the International Featured Standard (IFS, 7th ed.), outlining standardization for international equivalence (while maintaining the necessary flexibility and independence – which is not always easy an easy task).Providing selected specific examples, it examines the problems of chemical additives and possible cross-contaminations between different production lines, as well as adequate reactions to and handling of intentional adulterations. In addition, it includes a chapter focusing on quality audits and technical data sheets in the food industry, and a final chapter describing the certification of food-grade lubricants in the food industry, especially with regard to allergenic substances. |
| fda food fraud vulnerability assessment tool: Terrorist Threats to Food World Health Organization. Food Safety Department, 2002 While only a few cases of intentional contamination of food have been proven, the risk of possible terrorist threats to food should be given serious consideration by public health authorities and the food industry.This document examines means of establishing basic prevention, surveillance and response capacities. Because both unintentionally and deliberately caused outbreaks of foodborne disease may be managed by many of the same mechanisms, the WHO recommendations concentrate on working with national governments on integrating terrorism prevention and response measures into existing national food safety and disease surveillance programmes.Preventive measures by governments and the food industry are discussed. Industry involvement is encouraged from the outset, as the food industry possesses the primary means and greatest ability to minimize food-related risks. Existing food safety management programmes can be enhanced, WHO says, while putting in place appropriate security measures to protect food production and distribution systems. The document provides suggestions for specific measures for consideration by industry.The document provides guidance on strengthening existing communicable disease control systems to ensure that surveillance systems are sufficiently sensitive to meet the threat of any food safety emergency.The guidance document emphasizes the need to strengthen existing emergency alert and response systems by improving links with all relevant agencies and with the food industry. Many developed and most developing countries are not yet adequately prepared to deal with a large-scale food safety emergency. All countries should undertake preparedness and response planning to be able to cope with food safety emergencies regardless of their cause. In this regard, the services of various technical programmes of WHO as well as other organizations that may be of assistance to countries in addressing this newly emerging public health concern are also described in the document.Experts from national agencies in Australia, Germany, Ireland, Japan, Russia, Spain, United Kingdom, and United States of America, and from organizations including the European Commission, the Food and Agriculture Organization of the United Nations and the Industry Council for Development contributed to the development of the document. |
| fda food fraud vulnerability assessment tool: Swainson's Handbook of Technical and Quality Management for the Food Manufacturing Sector M Swainson, 2018-11-15 This book is focused on the expansive and highly demanding subject of Food Industry Technical & Quality Management. As the world's most vital industry Food Production is complex, multifaceted and continuously scrutinised. Food scares and product recalls, on national and international scales, demonstrate the persistent challenge to identify, monitor and control all hazards, and also address the increasing criminal threats of Food Fraud, Adulteration & Intentional Contamination. With the benefit of unique perspectives gained by working across Quality, Technical and Operations Management roles at all levels within the food industry, Swainson's Handbook of Technical and Quality Management considers the very diverse remits and particular challenges of those working to assure product Quality, Safety and Legality in the sector. This book provides insights and guidance on the Applied Practice of Industrial Quality and Technical Management, written from the perspective of the industry practitioner. Knowing what to do is half of the challenge, but being able to then make it happen is crucial – a fact which is often less well considered in food sector information resources. Split into two sections, the book first reviews generic aspects of Food Quality and Technical Management activities with particular regard to: Food Sector Challenges and the Role of Technical and Quality Management; Defining Technical and Quality Standards; The Food Safety and Quality Management System; Raw Materials and Packaging Supplier Control; Site Standards; Product Control and HACCP Considerations; Operations and Process Control; Personnel Control; Audits; Non-Conformance, Recall & Crisis Management; Managing the Technical Department. In the second part of the book Guest Authors share their expertise on a range of specialist topics, providing significant breadth and depth to the content which includes: Review of Third party audit schemes; Insights into supplying supermarkets with regard to good technical and quality management practices; Enforcement authority perspectives on the food manufacturing sector. Also covered are the specific sector challenges of food quality and safety assurance in Fruit and vegetables; Herbs and spices, Cereals, Baked products, Canning and Cook – Chill Ready Meals, Soups and Sauces. - Compiled expertise of food sector specialists with extensive industrial experience. - Edited by an industry and academic expert with over 25 years experience of technical and quality management in the food sector. - Contains Technical and Quality Management information that is relevant to a wide range of sectors in the food industry. - Also examines Technical and Quality Management practice in specific food applications and reviews relevant compliance standards. |
| fda food fraud vulnerability assessment tool: Report of the Health Officer District of Columbia. Health Department, 1886 |
| fda food fraud vulnerability assessment tool: Food Safety in China Joseph Jwu-Shan Jen, Junshi Chen, 2017-05-08 From contaminated infant formula to a spate of all-too familiar headlines in recent years, food safety has emerged as one of the harsher realities behind China's economic miracle. Tainted beef, horse meat and dioxin outbreaks in the western world have also put food safety in the global spotlight. Food Safety in China: Science, Technology, Management and Regulation presents a comprehensive overview of the history and current state of food safety in China, along with emerging regulatory trends and the likely future needs of the country. Although the focus is on China, global perspectives are presented in the chapters and 33 of the 99 authors are from outside of China. Timely and illuminating, this book offers invaluable insights into our understanding of a critical link in the increasingly globalized complex food supply chain of today's world. |
| fda food fraud vulnerability assessment tool: Edible Insects Arnold van Huis, Food and Agriculture Organization of the United Nations, 2013 Edible insects have always been a part of human diets, but in some societies there remains a degree of disdain and disgust for their consumption. Although the majority of consumed insects are gathered in forest habitats, mass-rearing systems are being developed in many countries. Insects offer a significant opportunity to merge traditional knowledge and modern science to improve human food security worldwide. This publication describes the contribution of insects to food security and examines future prospects for raising insects at a commercial scale to improve food and feed production, diversify diets, and support livelihoods in both developing and developed countries. It shows the many traditional and potential new uses of insects for direct human consumption and the opportunities for and constraints to farming them for food and feed. It examines the body of research on issues such as insect nutrition and food safety, the use of insects as animal feed, and the processing and preservation of insects and their products. It highlights the need to develop a regulatory framework to govern the use of insects for food security. And it presents case studies and examples from around the world. Edible insects are a promising alternative to the conventional production of meat, either for direct human consumption or for indirect use as feedstock. To fully realise this potential, much work needs to be done by a wide range of stakeholders. This publication will boost awareness of the many valuable roles that insects play in sustaining nature and human life, and it will stimulate debate on the expansion of the use of insects as food and feed. |
| fda food fraud vulnerability assessment tool: Managing Agricultural Greenhouse Gases Mark Liebig, A.J. Franzluebbers, Ronald F Follett, 2012-10-16 Global climate change is a natural process that currently appears to be strongly influenced by human activities, which increase atmospheric concentrations of greenhouse gases (GHG). Agriculture contributes about 20% of the world's global radiation forcing from carbon dioxide, methane and nitrous oxide, and produces 50% of the methane and 70% of the nitrous oxide of the human-induced emission. Managing Agricultural Greenhouse Gases synthesizes the wealth of information generated from the GRACEnet (Greenhouse gas Reduction through Agricultural Carbon Enhancement network) effort with contributors from a variety of backgrounds, and reports findings with important international applications. - Frames responses to challenges associated with climate change within the geographical domain of the U.S., while providing a useful model for researchers in the many parts of the world that possess similar ecoregions - Covers not only soil C dynamics but also nitrous oxide and methane flux, filling a void in the existing literature - Educates scientists and technical service providers conducting greenhouse gas research, industry, and regulators in their agricultural research by addressing the issues of GHG emissions and ways to reduce these emissions - Synthesizes the data from top experts in the world into clear recommendations and expectations for improvements in the agricultural management of global warming potential as an aggregate of GHG emissions |
| fda food fraud vulnerability assessment tool: Definitions and Standards for Food United States. Food and Drug Administration, 1951 |
| fda food fraud vulnerability assessment tool: Biotechnological Approaches in Food Adulterants Madan L Verma, 2020-11-18 The book highlights the biotechnological advancement in the area of food adulterants and outlines the current state of art technologies in the detection of food adulterants using omics and nanobiotechnology. The book provides insights to the most recent innovations, trends, concerns, and challenges in food adulterants. It identifies key research topics and practical applications of modern cutting-edge technologies employed for detection of food adulterants including: expansion of food adulterants market, potential toxicity of food adulterants and the prevention of food adulteration act, cutting-edge technology for food adulterants detection, and biosensing and nanobiosensing based detection of food adulterants. There is need for new resources in omics technologies for the application of new nanobiotechnology. Biotechnological Approaches in Food Adulterants provides an overview of the contributions of food safety and the most up-to-date advances in omics and nanobiotechnology approaches to a diverse audience from postgraduate students to researchers in biochemical engineering, biotechnology, food technologist, environmental technologists, and pharmaceutical professionals. |
| fda food fraud vulnerability assessment tool: FDA Regulation of Medical Devices Judith A. Johnson, 2012-07-06 On June 20, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, S. 3187 (EAH), the Food and Drug Administration Safety and Innovation Act, as amended. This bill would reauthorize the FDA prescription drug and medical device user fee programs (which would otherwise expire on September 30, 2012), create new user fee programs for generic and biosimilar drug approvals, and make other revisions to other FDA drug and device approval processes. It reflects bicameral compromise on earlier versions of the bill (S. 3187 [ES], which passed the Senate on May 24, 2012, and H.R. 5651 [EH], which passed the House on May 30, 2012). The following CRS reports provide overview information on FDA's processes for approval and regulation of drugs: CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul; CRS Report RL33986, FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by Susan Thaul; CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson; CRS Report R42508, The FDA Medical Device User Fee Program, by Judith A. Johnson. (Note: The rest of this report has not been updated since December 28, 2011.) Prior to and since the passage of the Medical Device Amendments of 1976, Congress has debated how best to ensure that consumers have access, as quickly as possible, to new and improved medical devices and, at the same time, prevent devices that are not safe and effective from entering or remaining on the market. Medical devices regulation is complex, in part, because of the wide variety of items that are categorized as medical devices; examples range from a simple tongue depressor to a life-sustaining heart valve. The regulation of medical devices can affect their cost, quality, and availability in the health care system. In order to be legally marketed in the United States, many medical devices must be reviewed by the Food and Drug Administration (FDA), the agency responsible for protecting the public health by overseeing medical products, including devices. FDA's Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device review. CDRH activities are funded through a combination of public money (i.e., direct FDA appropriations from Congress) and private money (i.e., user fees collected from device manufacturers) which together comprise FDA's total. User fees account for 33% of FDA's total FY2011 program level and 15% of CDRH's program level, which is $378 million in FY2011 including $56 million in user fees. FDA's authority to collect user fees, originally authorized in 2002 (P.L. 107-250), has been reauthorized in five-year increments. It will expire on October 1, 2012, under the terms of the Medical Device User Fee Act of 2007 (MDUFA), Title II of the FDA Amendments Act of 2007 (FDAAA, P.L. 110-85). FDA requires all medical product manufacturers to register their facilities, list their devices with FDA, and follow general controls requirements. FDA classifies devices according to the risk they pose to consumers. Premarket review is required for moderate- and high-risk devices. There are two paths that manufacturers can use to bring such devices to market. One path consists of conducting clinical studies, submitting a premarket approval (PMA) application and requires evidence providing reasonable assurance that the device is safe and effective. The other path involves submitting a 510(k) notification demonstrating that the device is substantially equivalent to a device already on the market (a predicate device) that does not require a PMA. The 510(k) process results in FDA clearance and tends to be much less expensive and less time- consuming than seeking FDA approval via PMA. |
| fda food fraud vulnerability assessment tool: Toxicity Testing in the 21st Century National Research Council, Division on Earth and Life Studies, Institute for Laboratory Animal Research, Board on Environmental Studies and Toxicology, Committee on Toxicity Testing and Assessment of Environmental Agents, 2007-10-05 Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides. |
| fda food fraud vulnerability assessment tool: Food Science and Technology Oluwatosin Ademola Ijabadeniyi, 2023-11-06 Food Science and Technology: Fundamentals and Innovation presents the aspects of microbiology, chemistry, nutrition, and process engineering required for the successful selection, preservation, processing, packaging, and distribution of quality food. It is a valuable resource for researchers and students in food science & technology and food industry professionals and entrepreneurs. There are two new chapters in the 2nd Ed. COVID-19 and food supply chain as well as climate-smart food science. |
| fda food fraud vulnerability assessment tool: Red Book Thomson, 2008 The new 2008 Red Book not only presents the latest pricing and product information on more than 160,000 prescription and over-the-counter items, but also a complete list of newly FDA-approved brands, generics, and biologics. |
| fda food fraud vulnerability assessment tool: Sorting the Beef from the Bull Richard Evershed, Nicola Temple, 2016-02-25 Horsemeat in burgers was hard to swallow, but there are far more sinister culinary crimes afoot... Chicken eggs that haven't come from chickens, melamine in infants' milk in China, nut shells in spices – these are just some examples of the food fraud that has occurred in recent years. As our urban lifestyle takes us further and further away from our food sources, there are increasing opportunities for dishonesty, duplicity and profit-making short-cuts. Food adulteration, motivated by money, is an issue that has spanned the globe throughout human history. Whether it's a matter of making a good quality oil stretch a bit further by adding a little extra 'something' or labelling a food falsely to appeal to current consumer trends – it's all food fraud, and it costs the food industry billions of dollars each year. The price to consumers may be even higher, with some paying for these crimes with their health and, in some cases, their lives. Sorting the Beef from the Bull is a collection of food fraud tales from around the world. It explains the role of science in uncovering some of the century's biggest food scams, and explores the arms race between food forensics and fraudsters as new methods of detection spur more creative and sophisticated means of committing the crimes. This book equips us with the knowledge of what is possible in the world of food fraud and shines a light on the shady areas of our food supply system where these criminals lurk. |
| fda food fraud vulnerability assessment tool: New Medical Devices Institute of Medicine, National Academy of Engineering, 1988-01-01 In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices. |
U.S. Food and Drug Administration
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FDA Approves First Nasal Spray for Treatment of Anaphylaxis
The FDA approved the first nasal spray for the emergency treatment of allergic reactions, including those that are life-threatening, in adult and pediatric patients who weigh at least 30 …
U.S. Food and Drug Administration
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological …
Drugs | FDA - U.S. Food and Drug Administration
Find information about most FDA-approved prescription, generic, and over-the-counter drug products. Drug Shortages Find information about …
What We Do | FDA - U.S. Food and Drug Administration
FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and …
About FDA | FDA - U.S. Food and Drug Administration
More than 18,000 FDA employees work in all 50 states and internationally to ensure the safety and effectiveness of human and veterinary medicines, …
Contact FDA | FDA - U.S. Food and Drug Administration
Oct 21, 2024 · View FDA’s proposed regulations and submit comments online (on Regulations.gov). How to comment on proposed regulations …
