Food and Drug Law Commons^™

Why Food In The United States May (Still) Never Be Safe: A Look Back At My Over Thirty Years Thinking About Food And The Law, Denis Stearns

Journal of Food Law & Policy

This article can serve a function as a concluding section—a kind of coda—for issues addressed in greater depth by the author (Denis Stearns) before.

This article also allows Sterns to return to a central question that prompted his thought-journey in the first place: Why does the food in this country continue to be so unsafe, despite all of the laws, all of the enforcement efforts, all of the food safety advocacy, and all of the lawsuits filed to recover damages on behalf of people injured and killed year after year. What follows, then, are additional and updated conclusions that thirty …

Negotiating Food Security, Maria Cudowska

Journal of Food Law & Policy

In the United States and worldwide, nutrition and food emerge as both high-profile public policy targets and as fundamental aspects of the right to self-determination. This Article examines how national security impacts food security in the United States. It explores conflicts and synergies between municipal, state, and federal law developments related to the right to food and investigates recent developments in how those commitments have been negotiated. The challenge and nebulous justiciability of the right to food can be in part attributed to existing global and national systems, which include supply chains, welfare programs, and foreign investment in the U.S. …

Developing An Efficient Regulatory Framework For Safe Street Food In Bangladesh: Lessons From Comparative Analyses With India, Thailand, And New York City, Usa., Abu Noman Mohammad Atahar Ali

Journal of Food Law & Policy

Globally, approximately 2.5 billion individuals consume street food1 daily. Street food is affordable, convenient, and sometimes nutritious, offering diverse and appealing food choices. A World Health Organization (WHO) report in 1996 ascertained that 74% of countries recognized the substantial contribution of street foods to their urban food supply The following parts of the article look into street food's impact on public health and its implications for the lives of people in Bangladesh. Subsequently, it will examine previous initiatives and current endeavors to ensure street food safety and hygiene. Following this literature review, the study will conduct a detailed examination of …

Federal Food Safety Framework: Where Does Seaweed Fit In?, Catherine M. Janasie

Journal of Food Law & Policy

When one mentions seaweed as food, what do you think of? The dried nori used to wrap your sushi roll or perhaps the seaweed salad on the side? In fact, seaweed has many uses, including as both a food source in its own right and as a food additive. While the seaweed market has been dominated by East Asian countries, seaweed is cultivated in about 50 countries, and the U.S. seaweed industry is steadily growing. The global seaweed industry is currently worth about $6 billion annually. Food products for human consumption account for about 85% of this value.

Novel Food Ingredients: Food Safety Law, Animal Testing, And Consumer Perspectives, Taimie Bryant

Marquette Law Review

In recent years, some major food companies have publicly stated that they will no longer test their product ingredients on animals. Yet despite the availability of more reliably predictive non-animal toxicity tests, some companies continue testing novel food ingredients on animals. This Article uses the lens of a particular innovative plant-based food company’s decision to test a novel food ingredient on animals as a means of considering more generally whether any food producer has rational legal reasons for testing on animals. The Article explores FDA requirements, consumer food safety litigation, and judicial evaluation of animal test data, all of which …

Eaters, Powerless By Design, Margot J. Pollans

Michigan Law Review

Food law, including traditional food safety regulation, antihunger programs, and food system worker protections, has received increased attention in recent years as a distinct field of study. Bringing together these disparate areas of law under a single lens provides an opportunity to understand the role of law in shaping what we eat (what food is produced and where it is distributed), how much we eat, and how we think about food. The food system is rife with problems— endemic hunger, worker exploitation, massive environmental externalities, and diet-related disease. Looked at in a piecemeal fashion, elements of food law appear responsive …

The New Food Safety, Margot J. Pollans, Emily M. Broad Leib

Elisabeth Haub School of Law Faculty Publications

A safe food supply is essential for a healthy society. Our food system is replete with different types of risk, yet food safety is often narrowly understood as encompassing only foodborne illness and other risks related directly to food ingestion. This Article argues for a more comprehensive definition of food safety, one that includes not just acute, ingestion-related risks, but also whole-diet cumulative ingestion risks, and cradle-to-grave risks of food production and disposal. This broader definition, which we call “Food System Safety,” draws under the header of food safety a variety of historically siloed, and under-regulated, food system issues including …

Blockchain Meets Genomics: Governance Considerations For Promoting Food Safety And Public Health, Walter G. Johnson

Journal of Food Law & Policy

Foodborne illness remains an ongoing public health challenge in both the developing and industrialized worlds. In the United States, almost 50 million reported cases of infectious disease occur every year from a food product, resulting in substantial morbidity and mortality with economic burdens to health care and productivity. Despite recognition as a leader in food safety, the U.S. experiences longstanding and novel issues in food safety. Advances in whole genome sequencing (WGS) promise to bolster food safety regulators’ capabilities to identify pathogens and determine their source. However, inefficiencies in tracing food products through the supply chain remain.

Food With Integrity?: How Responsible Corporate Officer Prosecutions Under The Federal Food, Drug, And Cosmetic Act Deny Fair Warning To Corporate Officers, Clay D. Sapp

Arkansas Law Review

[W]hen it comes to food safety, we have to rely on the companies that manufacture and distribute food to ensure that the food we buy is safe. In fact, most consumers give little thought to the safety of their food. I know I don’t and I bet many of you don’t either. We simply don’t expect to get sick from the food at our favorite restaurant, or from peanut butter or the eggs or the cantaloupes or the countless other products that we buy at the supermarket. That is why food safety is a priority for the Justice Department. Our …

Will The Trump Administration Support Farmers Facing Fsma Compliance?, Sophia Kruszewski

Journal of Food Law & Policy

In keeping with Donald Trump’s campaign promises of cutting burdensome regulations, this essay recommends two Food Safety Modernization Act (FSMA) regulations that should be removed or altered. The two regulations are for irrigation water quality standards and third-party audits. This essay argues that these regulations are unnecessary in keeping with the goals of FSMA and are burdensome for farmers of all scales, but especially small and very small scale farmers.

Farming And Eating, Margot J. Pollans

Journal of Food Law & Policy

There has long been tension between rural and urban communities, often referred to as the urban-rural divide. Donald Trump’s presidential campaign has exacerbated this divide. However, urban and rural groups rely on each other; farmers need eaters in densely populated areas for markets and eaters need farmers for food. In recognition of this codependency, this essay proposes a coalition of farmers, food consumers, and environmentalists to lead agricultural policy and stop the divide between farming and eating.

Assessing The Relative Influence And Efficacy Of Public And Private Food Safety Regulation Regimes: Comparing Codex And Global Gap Standards, Sam F. Halabi, Ching-Fu Lin

Faculty Publications

An extensive global system of private food regulation is under construction, one that exceeds conventional regulation, thought of as being driven by public authorities like FDA and USDA in the U.S. or the Food Standards Agency in the UK. Agrifood and grocer organizations, in concert with some farming groups, have been the primary designers of this new food regulatory regime. These groups have established alliances that compete with national regulators in complex ways. This article analyzes the relationship between public and private sources of food safety regulation by examining standards adopted by the Codex Alimentarius Commission, a food safety organization …

Moving In Opposite Directions? Exploring Trends In Consumer Demand And Agricultural Production, Susan A. Schneider

Mitchell Hamline Law Review

No abstract provided.

Pasture To Package: Ensuring Food Safety Compliance And Animal Welfare Integrity In Grass-Fed Beef Production, Lauren Manning

Mitchell Hamline Law Review

No abstract provided.

Pitfalls Of The Food Safety Modernization Act: Enhanced Regulation, Minimal Consumer Benefit, And Zero Tolerance Levels For Naturally-Occurring Trace Pathogens, Lindsey Lazopoulos Friedman, Wesley Van Camp

University of Miami Inter-American Law Review

Congress enacted the Food Safety Modernization Act (“FSMA”), to regulate the fresh produce industry in the United States and increase consumer safety when handling and consuming raw produce. But FSMA risks imposing a zero tolerance policy on raw produce, even where a naturally occurring low-level pathogen, such as listeria, is found in negligible amounts. A zero tolerance policy for all naturally-occurring pathogens does not increase consumer safety, and only serves to increase the cost of raw produce for consumers. This article begins with a summary of the modern history of FSMA, including a brief overview of how the law has …

Fsma: The Future Of Food Litigation, Robert Shawn Hogue

University of Miami Inter-American Law Review

No abstract provided.

Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi

Faculty Articles

No abstract provided.

A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks

Publications

Although food safety is a significant and increasing global health concern, international economic law does not adequately address today’s global food safety needs. While most countries rely on a collection of formalized legal rules to protect food safety, these rules too often fall short. As fiscal constraints impede raising the number of border inspections, formal international commitments (treaties) frequently limit governmental efforts to raise food safety standards. Private companies, meanwhile, can readily adopt higher standards to meet consumer demands and supply chain needs, thus demonstrating more nimbleness and flexibility in adopting the highest food safety standards available. Can countries learn …

The Right To Regulate (Cooperatively), Alexia Brunet Marks

Publications

The growing number of new technologies in food production— such as nanotechnology, genetic modification, animal cloning, and irradiation—are garnering different regulatory responses around the world. Based on their threshold for tolerating risk, countries are asserting their national right to regulate at home using labeling, quarantine, and outright bans on foods. But domestic regulation has its limits in a free trade environment. Countries that are not mindful of treaty obligations could face legal liability, as seen in the recent litigation between Uruguay and Philip Morris International. In short, traditional models of international regulatory cooperation (IRC) are failing to provide countries with …

The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan Jr.

Brooklyn Law Review

Foodborne illnesses sicken millions and kill thousands of Americans every year, leading many to conclude that our dysfunctional government food safety system, which still relies heavily on physical inspections of food and facilities, is incapable of protecting us. As a result, many now look to the private market for solutions to our food safety crisis. One private market approach, food safety liability insurance, is gaining popularity. This article examines the benefits and drawbacks to food safety liability insurance and raises doubts about its ability to improve food safety. The market for safe food is plagued by overwhelming information problems that …

Keeping The Farm And Farmer In Food Policy And Law, Neil D. Hamilton

Journal of Food Law & Policy

Thank you for the opportunity to be with you, it is always a pleasure to return to the University of Arkansas Law School where I began my teaching career in the fall of 1981. We are pleased Drake University Law School and the University of Arkansas College of Law have built and maintained a partnership on teaching and research that stretches back over three decades. I am especially pleased to be with you as we celebrate the 10th Anniversary of the Journal of Food Law and Policy, another part of the University's pioneering work in the area of food policy …

Regulating Farming: Balancing Food Safety And Environmental Protection In A Cooperative Governance Regime, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

After providing a brief overview of regulation in each area, Part I of this Article identifies three types of discordance between produce safety and environmental protection on farms. First, because of limited resources, farmers will have to choose between implementing food safety practices and implementing environmental practices. Second, indirect trade-offs between the two regulatory goals result in damaging collateral consequences for the environment. Food safety regulation may exacerbate a range of existing environmental harms. Third, there is at least one direct clash that may make compliance with food safety law incompatible with participation in certain environmental programs. Part I also …

The Codex Alimentarius Commission, Corporate Influence, And International Trade: A Perspective On Fda's Global Role, Sam F. Halabi

Faculty Publications

Section 305 of the FDA Food Safety Modernization Act specifically calls for FDA to develop recommendations on whether and how to harmonize requirements under the Codex Alimentarius Commission (“Codex”), an international organization charged with developing food standards, guidelines, codes of practice and “other recommendations to ensure fair practices in food trade and protect[ion of] the health of consumers.” FDA’s International Food Safety Capacity-Building Plan is largely supportive and deferential to Codex, concluding that “the use of Codex standards helps assure a safe global food supply.” To be sure, Codex’s stated mission and policies should create and facilitate adoption of universal …

The Risks We Are Willing To Eat: Food Imports And Safety, Alexia Brunet Marks

Publications

Recent efforts to regulate the safety of U.S. food imports have not kept up with the complexity of global trade and the risks that accompany globalization. Congress drafted the Food Safety Modernization Act of 2011 ("FSMA") in response to heightened food safety risks, surging imports, and an outdated food import safety system. While the FSMA provides the Food and Drug Administration ("FDA") additional authority to regulate food facilities, establish standards for safe produce, recall contaminated foods, and oversee imported foods, vulnerabilities still exist.

This article exposes problems with the old system of food import rules and significant challenges facing the …

Prosser's Bait-And-Switch: How Food Safety Was Sacrificed In The Battle For Tort's Empire, Denis W. Stearns

Nevada Law Journal

No abstract provided.

The Rise Of Transnational Private Meta-Regulators, Paul Verbruggen, Tetty Havinga

Transnational Business Governance Interactions Working Papers

In recent years scholars from various disciplines have turned their attention to transnational regimes of regulation that are chiefly developed outside state-driven frameworks. The rise of such "transnational private regulation" has also led to the emergence of private meta-regulation. The term 'meta-regulation' commonly refers to processes through which a regulatory body oversees another and sets standards for its activities or performance of regulation. In the public domain, meta-regulation has been associated with the devolution of regulatory activities by a statutory body to private actors with the view to enhance voluntary rule compliance, awareness of responsibilities among the regulated and reduce …

The Market For Drug-Free Poultry: Why Robust Regulation Of Animal Raising Claims Is The Right Prescription To Combat Antibiotic Resistance, Dorinda L. Peacock

Journal of Food Law & Policy

Since their introduction in the mid-twentieth century, antibiotics have become a mainstay of poultry production for purposes ranging from growth promotion to disease treatment and control. Nevertheless, for almost as long, there have been concerns about the role that these agricultural uses play in the development of antibiotic resistant bacteria. The issue of antibiotic resistance in general is fast becoming a public health crisis and scrutiny of agriculture as a contributing cause continues. Nevertheless, to date, neither regulatory efforts to curb agricultural usage nor private sector actions in response to consumer demand and public-interest campaigns have led to significant changes …

Public-Private Regime Interactions In Global Food Safety Governance, Ching-Fu Lin

Transnational Business Governance Interactions Working Papers

In response to an apparent decline in global food safety, numerous public and private regulatory initiatives have emerged to restore public confidence. This trend has been particularly marked by the growing influence of private regulators such as multinational food companies, supermarket chains and non-governmental organizations (NGOs), who employ private standards, certification protocols, third-party auditing, and transnational contracting practices. This paper explores how the structure and processes of private food safety governance interact with traditional public governance regimes, focusing on Global Good Agricultural Practices (GlobalGAP) as a primary example of the former. Due to the inefficiency and ineffectiveness of public regulation …

Check Please: Using Legal Liability To Inform Food Safety Regulation, Alexia Brunet Marks

Publications

Food safety is a hotly debated issue. While food nourishes, sustains, and enriches our lives, it can also kill us. At any given meal, our menu comes from a dozen different sources. Without proper incentives to encourage food safety, microbial pathogens can, and do enter the food source--so much so that according to the Centers for Disease Control and Prevention (CDC), each year roughly one in six Americans (or forty-eight million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. What is the optimal way to prevent unsafe foods from entering the marketplace?

Safety in the food …

Global Environmental Law: Food Safety & China, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

This article makes the case for food security law and policy as a component of global environmental law in recognition of the global economy, trade liberalization, and concerns for food safety and environmental harm. It further describes rule of law as a significant force in mitigating food safety concerns and pollution in China. Part II explores global food safety concerns in the context of United States-China relations, while Part III discusses the U.S. Food & Drug Administration's on-the-ground presence in China as an example of the emergence of cooperative agreements in global environmental governance. Part IV shows how increased rule …