Working With Government Agencies In Food And Drug Law

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Enhancing Food Safety

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309163587
Total Pages : 589 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Enhancing Food Safety by : National Research Council

Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.

Ensuring Safe Food

Author : Institute of Medicine and National Research Council
Publisher : National Academies Press
ISBN 13 : 0309173973
Total Pages : 208 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ensuring Safe Food by : Institute of Medicine and National Research Council

Download or read book Ensuring Safe Food written by Institute of Medicine and National Research Council and published by National Academies Press. This book was released on 1998-08-19 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: How safe is our food supply? Each year the media report what appears to be growing concern related to illness caused by the food consumed by Americans. These food borne illnesses are caused by pathogenic microorganisms, pesticide residues, and food additives. Recent actions taken at the federal, state, and local levels in response to the increase in reported incidences of food borne illnesses point to the need to evaluate the food safety system in the United States. This book assesses the effectiveness of the current food safety system and provides recommendations on changes needed to ensure an effective science-based food safety system. Ensuring Safe Food discusses such important issues as: What are the primary hazards associated with the food supply? What gaps exist in the current system for ensuring a safe food supply? What effects do trends in food consumption have on food safety? What is the impact of food preparation and handling practices in the home, in food services, or in production operations on the risk of food borne illnesses? What organizational changes in responsibility or oversight could be made to increase the effectiveness of the food safety system in the United States? Current concerns associated with microbiological, chemical, and physical hazards in the food supply are discussed. The book also considers how changes in technology and food processing might introduce new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that need additional study. Ensuring Safe Food will be important for policymakers, food trade professionals, food producers, food processors, food researchers, public health professionals, and consumers.

Food and Drug Regulation

Author : ADAM I. MUCHMORE
Publisher :
ISBN 13 : 9781531004453
Total Pages : 734 pages
Book Rating : 4.0/5 (44 download)

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Book Synopsis Food and Drug Regulation by : ADAM I. MUCHMORE

Download or read book Food and Drug Regulation written by ADAM I. MUCHMORE and published by . This book was released on 2021-03-14 with total page 734 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Dietary Supplements

Author : United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Dietary Supplements by : United States. Federal Trade Commission. Bureau of Consumer Protection

Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pain Management and the Opioid Epidemic

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309459575
Total Pages : 483 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine

Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Jungle

Author : Upton Sinclair
Publisher :
ISBN 13 :
Total Pages : 442 pages
Book Rating : 4.A/5 ( download)

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Book Synopsis The Jungle by : Upton Sinclair

Download or read book The Jungle written by Upton Sinclair and published by . This book was released on 1920 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt:

An Overview of FDA Regulated Products

Author : Eunjoo Pacifici
Publisher : Academic Press
ISBN 13 : 0128111569
Total Pages : 292 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis An Overview of FDA Regulated Products by : Eunjoo Pacifici

Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations

Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309184134
Total Pages : 158 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies by : Institute of Medicine

Download or read book Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies written by Institute of Medicine and published by National Academies Press. This book was released on 1999-04-29 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Food Law

Author : Jacob E. Gersen
Publisher : Aspen Publishing
ISBN 13 : 1454898410
Total Pages : 903 pages
Book Rating : 4.4/5 (548 download)

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Book Synopsis Food Law by : Jacob E. Gersen

Download or read book Food Law written by Jacob E. Gersen and published by Aspen Publishing. This book was released on 2018-09-14 with total page 903 pages. Available in PDF, EPUB and Kindle. Book excerpt: Food Law and Policy surveys the elements of modern food law. It broadens the coverage of traditional food and drug law topics of safety, marketing, and nutrition, and includes law governing environment, international trade, and other legal aspects of the modern food system. The result is the first casebook that provides a comprehensive treatment of food law as a unique discipline. Key Features: Draws together cases with other regulatory materials such as rulemaking documents and agency requests for proposals for grant funding. Focuses on federal law and includes discussion of innovations in food law happening at the municipal, state and federal level. Covers the latest developments in food law.

Business Law I Essentials

Author : MIRANDE. DE ASSIS VALBRUNE (RENEE. CARDELL, SUZANNE.)
Publisher :
ISBN 13 : 9781680923025
Total Pages : 180 pages
Book Rating : 4.9/5 (23 download)

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Book Synopsis Business Law I Essentials by : MIRANDE. DE ASSIS VALBRUNE (RENEE. CARDELL, SUZANNE.)

Download or read book Business Law I Essentials written by MIRANDE. DE ASSIS VALBRUNE (RENEE. CARDELL, SUZANNE.) and published by . This book was released on 2019-09-27 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: A less-expensive grayscale paperback version is available. Search for ISBN 9781680923018. Business Law I Essentials is a brief introductory textbook designed to meet the scope and sequence requirements of courses on Business Law or the Legal Environment of Business. The concepts are presented in a streamlined manner, and cover the key concepts necessary to establish a strong foundation in the subject. The textbook follows a traditional approach to the study of business law. Each chapter contains learning objectives, explanatory narrative and concepts, references for further reading, and end-of-chapter questions. Business Law I Essentials may need to be supplemented with additional content, cases, or related materials, and is offered as a foundational resource that focuses on the baseline concepts, issues, and approaches.

The Poison Squad

Author : Deborah Blum
Publisher : Penguin
ISBN 13 : 0525560289
Total Pages : 370 pages
Book Rating : 4.5/5 (255 download)

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Book Synopsis The Poison Squad by : Deborah Blum

Download or read book The Poison Squad written by Deborah Blum and published by Penguin. This book was released on 2018-09-25 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: A New York Times Notable Book The inspiration for PBS's AMERICAN EXPERIENCE film The Poison Squad. From Pulitzer Prize winner and New York Times-bestselling author Deborah Blum, the dramatic true story of how food was made safe in the United States and the heroes, led by the inimitable Dr. Harvey Washington Wiley, who fought for change By the end of nineteenth century, food was dangerous. Lethal, even. "Milk" might contain formaldehyde, most often used to embalm corpses. Decaying meat was preserved with both salicylic acid, a pharmaceutical chemical, and borax, a compound first identified as a cleaning product. This was not by accident; food manufacturers had rushed to embrace the rise of industrial chemistry, and were knowingly selling harmful products. Unchecked by government regulation, basic safety, or even labelling requirements, they put profit before the health of their customers. By some estimates, in New York City alone, thousands of children were killed by "embalmed milk" every year. Citizens--activists, journalists, scientists, and women's groups--began agitating for change. But even as protective measures were enacted in Europe, American corporations blocked even modest regulations. Then, in 1883, Dr. Harvey Washington Wiley, a chemistry professor from Purdue University, was named chief chemist of the agriculture department, and the agency began methodically investigating food and drink fraud, even conducting shocking human tests on groups of young men who came to be known as, "The Poison Squad." Over the next thirty years, a titanic struggle took place, with the courageous and fascinating Dr. Wiley campaigning indefatigably for food safety and consumer protection. Together with a gallant cast, including the muckraking reporter Upton Sinclair, whose fiction revealed the horrific truth about the Chicago stockyards; Fannie Farmer, then the most famous cookbook author in the country; and Henry J. Heinz, one of the few food producers who actively advocated for pure food, Dr. Wiley changed history. When the landmark 1906 Food and Drug Act was finally passed, it was known across the land, as "Dr. Wiley's Law." Blum brings to life this timeless and hugely satisfying "David and Goliath" tale with righteous verve and style, driving home the moral imperative of confronting corporate greed and government corruption with a bracing clarity, which speaks resoundingly to the enormous social and political challenges we face today.

FDA in the Twenty-First Century

Author : Holly Fernandez Lynch
Publisher : Columbia University Press
ISBN 13 : 0231540078
Total Pages : 499 pages
Book Rating : 4.2/5 (315 download)

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Book Synopsis FDA in the Twenty-First Century by : Holly Fernandez Lynch

Download or read book FDA in the Twenty-First Century written by Holly Fernandez Lynch and published by Columbia University Press. This book was released on 2015-09-08 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

Pure Food

Author : James Harvey Young
Publisher : Princeton University Press
ISBN 13 : 1400860326
Total Pages : 335 pages
Book Rating : 4.4/5 (8 download)

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Book Synopsis Pure Food by : James Harvey Young

Download or read book Pure Food written by James Harvey Young and published by Princeton University Press. This book was released on 2014-07-14 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Pure food" became the rallying cry among a divergent group of campaigners who lobbied Congress for a law regulating foods and drugs. James Harvey Young reveals the complex and pluralistic nature not only of that crusade but also of the broader Progressive movement of which it was a significant strand. In the vivid style familiar to readers of his earlier works, The Toadstool Millionaires and The Medical Messiahs, Young sets the pure food movement in the context of changing technology and medical theory and describes pioneering laws to control imported drugs and domestic oleomargarine. He explains controversy within the pure food coalition, showing how farming and business groups sought competitive commercial advantage, while consumer advocates wished to promote commercial integrity and advance public health. The author focuses on how the public became increasingly fearful of hazards in adulterated foods and narcotic nostrums and how Congress finally achieved the compromises necessary to pass the Food and Drugs Act and the meat inspection law of 1906. Originally published in 1989. The Princeton Legacy Library uses the latest print-on-demand technology to again make available previously out-of-print books from the distinguished backlist of Princeton University Press. These editions preserve the original texts of these important books while presenting them in durable paperback and hardcover editions. The goal of the Princeton Legacy Library is to vastly increase access to the rich scholarly heritage found in the thousands of books published by Princeton University Press since its founding in 1905.

Food Regulation

Author : Neal D. Fortin
Publisher : John Wiley & Sons
ISBN 13 : 1118964497
Total Pages : 1028 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis Food Regulation by : Neal D. Fortin

Download or read book Food Regulation written by Neal D. Fortin and published by John Wiley & Sons. This book was released on 2016-10-25 with total page 1028 pages. Available in PDF, EPUB and Kindle. Book excerpt: Featuring case studies and discussion questions, this textbook – with revisions addressing significant changes to US food law – offers accessible coverage appropriate to a wide audience of students and professionals. Overviews the federal statutes, regulations, and regulatory agencies concerned with food regulation and introduces students to the case law and statutory scheme of food regulation Focuses updated content on the 2011 FDA Food Safety Modernization Act (FSMA), the biggest change to US food law since the 1930s Contains over 20% new material, particularly a rewritten import law chapter and revisions related to food safety regulation, health claims, and food defense Features case studies and discussion questions about application of law, policy questions, and emerging issues

The Food and Drug Administration (FDA)

Author : Meredith A. Hickmann
Publisher : Nova Publishers
ISBN 13 : 9781590333877
Total Pages : 212 pages
Book Rating : 4.3/5 (338 download)

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Book Synopsis The Food and Drug Administration (FDA) by : Meredith A. Hickmann

Download or read book The Food and Drug Administration (FDA) written by Meredith A. Hickmann and published by Nova Publishers. This book was released on 2003 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: The FDA is responsible for ensuring the safety of foods, drugs, medical devices, cosmetics, and a variety of other products. These products account for 25 cents of every dollar US consumers spend. Under the authority of the Federal Food, Drug, and Cosmetic Act, FDA is responsible for ensuring that these products are safe, accurately labelled, and in the case of drugs and medical devices, effective. FDA's tasks include: enforcement, pre-market product evaluation and approval, post-market surveillance and investigations, publishing of regulations, conducting and monitoring of research, public education, and regulating products and processes to prevent hazards to human health. Contents: Preface; Food and Drug Administration: Selected Funding Data; Food and Drug Administration: Selected Funding and Policy Issues; US European Agricultural Trade: Food and Biotechnology Issues; Food and Drug Administration: Selected Funding and Policy Issues; Food and Drug Administration Modernisation Act of 1997 -- The Provisions; Index.

Outbreak

Author : Timothy D. Lytton
Publisher : University of Chicago Press
ISBN 13 : 022661168X
Total Pages : 357 pages
Book Rating : 4.2/5 (266 download)

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Book Synopsis Outbreak by : Timothy D. Lytton

Download or read book Outbreak written by Timothy D. Lytton and published by University of Chicago Press. This book was released on 2019-04-16 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: Foodborne illness is a big problem. Wash those chicken breasts, and you’re likely to spread Salmonella to your countertops, kitchen towels, and other foods nearby. Even salad greens can become biohazards when toxic strains of E. coli inhabit the water used to irrigate crops. All told, contaminated food causes 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths each year in the United States. With Outbreak, Timothy D. Lytton provides an up-to-date history and analysis of the US food safety system. He pays particular attention to important but frequently overlooked elements of the system, including private audits and liability insurance. Lytton chronicles efforts dating back to the 1800s to combat widespread contamination by pathogens such as E. coli and salmonella that have become frighteningly familiar to consumers. Over time, deadly foodborne illness outbreaks caused by infected milk, poison hamburgers, and tainted spinach have spurred steady scientific and technological advances in food safety. Nevertheless, problems persist. Inadequate agency budgets restrict the reach of government regulation. Pressure from consumers to keep prices down constrains industry investments in safety. The limits of scientific knowledge leave experts unable to assess policies’ effectiveness and whether measures designed to reduce contamination have actually improved public health. Outbreak offers practical reforms that will strengthen the food safety system’s capacity to learn from its mistakes and identify cost-effective food safety efforts capable of producing measurable public health benefits.

Oversight of Food Safety Activities

Author :
Publisher :
ISBN 13 :
Total Pages : 108 pages
Book Rating : 4.E/5 ( download)

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Book Synopsis Oversight of Food Safety Activities by :

Download or read book Oversight of Food Safety Activities written by and published by . This book was released on 2005 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: GAO has documented many problems resulting from the fragmented nature of the federal food safety system and recommended fundamental restructuring to ensure the effective use of scarce government resources. In this report, GAO (1) identified overlaps in food safety activities at USDA, FDA, EPA, and NMFS; (2) analyzed the extent to which the agencies use interagency agreements to leverage resources; and (3) obtained the views of stakeholders. Several statutes give responsibility for different segments of the food supply to different agencies to ensure that the food supply is safe. The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) have the primary responsibility for regulating food safety, with the Environmental Protection Agency (EPA) and the National Marine Fisheries Service (NMFS) also involved. In carrying out their responsibilities, with respect to both domestic and imported food, these agencies spend resources on a number of overlapping activities, such as inspection/enforcement, training, research, or rulemaking. For example, both USDA and FDA conduct similar inspections at 1,451 dual jurisdiction establishments--facilities that produce foods regulated by both agencies. Under authority granted by the Bioterrorism Act of 2002, FDA could authorize USDA inspectors to inspect these facilities, but it has not done so. Furthermore, USDA and FDA maintain separate training programs on similar topics for their inspectors that could be shared. Ultimately, inspection and training resources could be used more efficiently. GAO identified 71 interagency agreements that the agencies entered into to better protect public health and to coordinate their food safety activities. However, the agencies have weak mechanisms for tracking these agreements that, in some cases, lead to ineffective implementation. Specifically, USDA and FDA are not fully implementing an agreement to facilitate the exchange of information about dual jurisdiction establishments, which both agencies inspect. In addition, FDA and NMFS are not implementing an agreement designed to enable each agency to discharge its seafood responsibilities effectively. GAO spoke with selected industry associations, food companies, consumer groups, and academic experts, and they disagree on the extent of overlap and on how best to improve the food safety system. Most of these stakeholders agreed that laws and regulations should be modernized to more effectively and efficiently control food safety hazards, but they differed about whether to consolidate food safety functions into a single agency.