Food and Drug Law Commons^™

United States--Certain Measures Affecting Imports Of Poultry From China: The Fascinating Case That Wasn't, Donald H. Regan

Articles

US–Poultry (China) was the first Panel decision dealing with an origin-specific SPS measure, or with what the United States referred to as an ‘equivalence regime’. More specifically, it was the first instance in which the basis for the challenged measure was the claimed inability of the complainant country to enforce its own food-safety rules. Unfortunately, as the litigation developed, the very interesting novel issues raised by such a measure were not discussed. This essay discusses those novel issues – in particular, what sort of scientific justification or risk assessment should be required for a measure like this, and what SPS …

Toward A Constructive Engagement: Agricultural Biotechnology As A Public Health Incentive In Less-Developed Countries, Chidi Oguamanam

Journal of Food Law & Policy

Discourses on global public health crises, especially as they impact the less-developed world, focus mostly on the issue of access to life-saving drugs for needy populations. Also, they implicate the misalignment of global pharmaceutical research and development (R&D) agenda with the health needs of the poor. Equally attracting significant attention is the role of intellectual property in driving up the cost of drugs and exacerbating the drug access freeze to needy populations. More often, the conceptual strings of these discussions are woven around a complex interaction of themes, including those of globalization, the development narrative, and strategic changes in international …

United States Food Law Update: Moving Toward A More Balanced Food Regulatory Regime, A. Bryan Endres, Nicholas R. Johnson

Journal of Food Law & Policy

For decades, the federal government has played a significant role in promoting healthy eating. In the early 1900s, the United States Department of Agriculture (USDA) promoted a foundational diet of milk, proteins, fruits and vegetables, and grains. Most Americans are at least somewhat familiar, although perhaps confused, with the more nuanced healthy eating recommendations contained in the food pyramid - first employed in 1992. And virtually every American has experienced the federally supported school lunch program. In the first half of 2011, these two iconic programs underwent significant change as part of a stepped-up effort to improve the health of …

Food And Drug Administration Regulation Of Food Safety, Lawrence O. Gostin, Katie F. Stewart

Georgetown Law Faculty Publications and Other Works

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food safety. The act emphasizes prevention, enhanced recall authority, and oversight of imported food.

The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by focusing on preventing outbreaks, rather than reacting to them, and differentiating between foods and food producers based on the degree of risk they pose. The …

Canadian Food Law Update, Patricia L. Farnese

Journal of Food Law & Policy

Provided below is an overview of developments in Canadian food law and policy in 2010. This update primarily analyzes the regulatory and policy developments and litigation activities by the federal government. This focus reflects the significance of federal activities in the food policy realm.

Produce Exceptionalism: Examining The Leafy Greens Marketing Agreement And Its Ability To Improve Food Safety, Varun Shekhar

Journal of Food Law & Policy

Isolated food safety crises are not uncommon occurrences in the United States. Indeed, the history of public scares indicates a pattern of deficiencies in the safety of the American food supply. In the early 20th century, the public learned of the squalid conditions of meatpacking facilities through muckraking publications such as Upton Sinclair's The Jungle. In the 1980s, a 60 Minutes report documented research finding carcinogenic properties of a widespread pesticide, traces of which were commonly found in apple-based products. In the 1990s, widespread media reports of beef tainted with E. coli led to both product recalls unprecedented in scope …

Regulatory Dysfunction: How Insufficient Resources, Outdated Laws, And Political Interference Cripple The 'Protector Agencies', Sidney A. Shapiro, Rena I. Steinzor, Matthew Shudtz

Faculty Scholarship

In the last several years, dramatic failures of the nation’s food safety system have sickened or killed tens of thousands of Americans, and caused billions of dollars of damages for producers and distributors of everything from fresh vegetables to granola bars and hamburger meat. In each case, the outbreak of food-borne illness triggered what can only be described as a frantic scramble by health officials to discover its source. Inevitably, the wrong lead is followed or a recall is too late or too narrow to prevent further illnesses, and the government has to defend itself against withering criticism. Americans expect …

United States Food Law Update: Food Safely Planning, Attribute Labeling, And The Irradiation Debate, Bryan Endres

Journal of Food Law & Policy

This article summarizes significant changes and developments in food law throughout the second half of 2007. The previous edition of the Food Law Update noted the recent increase in imported food and the resulting stress placed on food safety agencies and customs officials. Detailed inspections of every food shipment entering the United States would quickly exhaust limited agency resources and cripple efficient international trade of food products. On the other hand, after several well-publicized food scares and the ongoing threat of international contamination, the public increasingly demands high levels of physical surveillance. As a part of this ongoing discussion, this …

United States Food Law Update, A. Bryan Endres

Journal of Food Law & Policy

Michael T. Roberts and Margie Alsbrook noted in the Journal's inaugural Food Law Update that "[t]he one constancy about food law in the United States is change, especially in a rapidly-developing food industry." This observation holds true today and also augurs a change in authorship of this section of the Journal. I hope to follow my colleagues' lead and provide timely and cogent updates of the federal (and occasionally state) statutes, regulations, and judicial decisions impacting food law and policy. It is both an honor and a duty, as food and its legal implications remain in many respects "the world's …

Food Safety And Security: What Tragedy Teaches Us About Our 100-Year-Old Food Laws, Caroline S. Dewaal

Vanderbilt Journal of Transnational Law

The United States food safety system is antiquated and failing. The laws that form the foundation of our food protection and govern the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) were enacted over 100 years ago. While some new powers were given to FDA with the Bioterrorism Act of 2002, funding has not kept pace. Safe Food International (SF), a coalition of consumer organizations from around the world, created a set of guidelines outlining an ideal national food safety program. The current system in the United States falls short of that goal. The outbreaks …

Legislative Implementation Of The Food Chain Approach, Jessica Vapnek

Vanderbilt Journal of Transnational Law

Food safety is an essential element of food security, since "adequate" food means food that is not only available, but also safe. Food safety systems have traditionally focused on end-product testing, which is an unsatisfactory means of ensuring safe food. An increasing focus on prevention has spurred interest in a food chain approach, which aims to control all steps in the food chain from production to consumption. Although the approach has drawn international attention in recent years, national lawmakers have lacked guidance on its implementation. This Article serves that need. Part II of the Article describes the international backdrop to …

Food Safety, South-North Asymmetries, And The Clash Of Regulatory Regimes, Obijiofor Aginam

Vanderbilt Journal of Transnational Law

This Article explores the globalization of food safety concerns driven by the phenomenon of economic globalization, and the "legalization" of food safety disputes within the rules-based architecture of the World Trade Organization (WTO). Focusing on the interaction between WTO norms and the treaties of other multilateral organizations, the Article discusses the implications of the "clash of food safety regulatory regimes" for South-North asymmetrical relations between the rich and poor countries. The Article also discusses global economic diplomacy and the emerging WTO jurisprudence on the Agreement on Sanitary and Phyto-Sanitary Measures (SPS) disputes. This Article explores both the perceived and actual …

'Beastly Bureaucracy' Animal Traceability, Identification And Labeling In Eu Law, Bernd M.J. Van Der Meulen, Annelies A. Freriks

Journal of Food Law & Policy

This contribution discusses animal traceability, identification and labeling requirements in European Union (EU) law. The requirements are lex specialis to more general requirements in EU food law. The aim is to set out this body of EU law and provide some understanding regarding its background. Along with the article by Margaret Rosso Grossman, it enables the reader to compare the EU system to the United States system.

Food Law & Policy: An Essay, Peter Barton Hutt

Journal of Food Law & Policy

Food has been the driving preoccupation of humans since the dawn of evolution. Exactly when food processing began and when the original hunter-gatherers settled down to develop agriculture-or even the question of which of these occurred first-remain issues of scholarly pursuit and debate. It is clear, however, that these events occurred millennia before the advent of recorded history; therefore, we must rely on largely adventitious discoveries of archeological artifacts to advance our developing knowledge of these events.

Public Perceptions Of Food Safety: Assessing The Risks Posed By Genetic Modification, Irradiation, Pesticides, Microbiological Contamination And High Fat/High Calorie Foods, Michael D. Mehta

The University of New Hampshire Law Review

[Excerpt] "In general, people in the developed world have access to a safe and varied supply of food. Instead of systemic hunger, many developed countries have problems with obesity and other kinds of eating disorders among their citizenry. It is within this context that some find public concerns about the safety of food both paradoxical and misplaced. Nevertheless, understanding how people perceive the risk associated with food is an important exercise in demonstrating accountability and in setting priorities for regulation. With the advent of technologies for producing genetically modified foods, and the development of fat blockers like Olestra, the public …

Bse: Risk, Uncertainty, And Policy Change, Enda Cummins, Pat Grace, Kevin Mcdonnell, Shane Ward

RISK: Health, Safety & Environment (1990-2002)

The authors discuss how, in our "risk society," a range of potential risks and uncertainties are associated with new technologies and new diseases, such as BSE. These risks bring with them worries about human health, while the ability to assess and manage new health scares is an essential skill for government and related industries.

Measuring Risks And Benefits Of Food Safety Decisions, Richard Zeckhauser

Vanderbilt Law Review

This Article discusses the assessment of risks and benefits as one approach to organizing information.The way information is organized should depend on the way it will be valued and used. For example, the decision making authorities within the regulatory process may choose to take different approaches to food substances consumed by young and old, or rich and poor. In that case, information should be organized into those categories. An exquisite breakdown of consumption patterns by counties would do little for an age-regarding regulatory process.The remainder of this Article is divided into four parts. Part II reviews the general nature of …

Regulating Carcinogens In Food: A Legislator's Guide To The Food Safety Provisions Of The Federal Food, Drug, And Cosmetic Act, Richard A. Merrill

Michigan Law Review

On March 9, 1977, the Food and Drug Administration (FDA) announced that a study in laboratory rats conducted by the Canadian government confirmed that saccharin is an animal carcinogen. For this reason, the agency stated, the sweetener must be banned from human food.

The studies which Congress mandated, to be accompanied by the recommendations of the Secretary of HEW, are likely to generate a fundamental reexamination of the nation's current food safety policies. This Article attempts to aid this inquiry by explaining the requirements of the present law. The Article describes the several statutory provisions that govern the regulation of …