Digital Commons Network^™

Bystanders To A Public Health Crisis: The Failures Of The U.S. Multi-Agency Regulatory Approach To Food Safety In The Face Of Persistent Organic Pollutants, Katya S. Cronin

GW Law Faculty Publications & Other Works

Per- and polyfluoroalkyl substances (“PFAS”) are devastating our food systems and our health. Recent studies link even small exposure to PFAS to a host of adverse health outcomes, including cancer, autoimmune diseases, thyroid disease, liver damage, childhood obesity, infertility, and birth defects.

Food consumption is a primary route of PFAS exposure. PFAS are omnipresent at dangerous levels in our marine and agricultural environments, including in water, soil, fertilizers, compost, and air. From there, they can find their way into virtually every plant, fish, animal, and animal product, and ultimately (in the greatest concentration) into the consumer. In addition, PFAS-laden food …

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 …

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 …

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 …

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 …

Food And Condiments For The Twenty-First Century: Business, Science, And Policy, Lewis D. Solomon

GW Law Faculty Publications & Other Works

We are in the midst of a paradigm shift in the food industry. People are more closely examining the impact of food not only on their health and wellness but also on the environment. Some are also concerned about the relationship between food and animal welfare as well as resource scarcities. Big food conglomerates face competition from upstart rivals. The for-profit companies profiled in this work, Nu-tek Food Science, Lyrical Foods, Hampton Creek, Beyond Meat, Impossible Foods, Modern Meadow, and Rosa Labs, are leading the reinvention of condiments and food. Although picking winners and also-rans represents a difficult endeavor, some …

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 …

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 …

Genealogies Of Risk: Searching For Safety, 1930s-1970s, William Boyd

Publications

Health, safety, and environmental regulation in the United States are saturated with risk thinking. It was not always so, and it may not be so in the future. But today, the formal, quantitative approach to risk provides much of the basis for regulation in these fields, a development that seems quite natural, even necessary. This particular approach, while it drew on conceptual and technical developments that had been underway for decades, achieved prominence during a relatively short timeframe; roughly, between the mid-1970s and the early 1980s--a time of hard looks and regulatory reform. Prior to this time, formal conceptions of …

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 …

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 …

High Crimes, Not Misdemeanors: Deterring The Production Of Unsafe Food, Rena I. Steinzor

Faculty Scholarship

In the fall of 2008, Minnesota public health officials became alarmed by an unusually high number of illnesses and deaths caused by salmonella poisoning. Federal and state regulators and the news media eventually traced the outbreak back to products supplied by the Peanut Corporation of America (PCA). Employees shipped batches that tested positive for salmonella from a plant with a leaking roof, mold growing on ceilings and walls, rodent infestation, filthy processing receptacles, and feathers and feces in the air filtration system. Under an agreement with the Food and Drug Administration (FDA), Georgia state inspectors visited the PCA plant nine …

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 …