This chapter provides an overview of the amalgamation of disparate elements that make up the food import regulatory system in the United States. This patchwork collection of authorities provides a useful laboratory to observe the effectiveness of the different regulatory approaches. The author discusses how this knowledge could best be used to create a more effective, prevention-based import regulatory system.
Science-based, preventative regulation was slow in coming to food law. It took more than half a century from the development of HACCP — Hazard Analysis and Critical Control Point — in the 1950s, for Congress to direct the Food and Drug Administration (FDA) to apply comprehensive, science-based, preventive controls across the food supply. Full implementation will likely take several years, but the FDA Food Safety Modernization Act (FSMA) signed into law on January 4, 2011, provides FDA with a mandate to shift the focus of the FDA from primarily reacting to food safety problems to prevention.
FSMA requires that all FDA regulated food companies implement a written hazard analysis and risk-based preventive control plan unless specifically exempt. In addition, FSMA directs FDA to work with the U.S. Department of Agriculture (USDA) to propose “science-based minimum standards for the safe production and harvesting” of fruits and vegetables that are raw agricultural commodities for which FDA has determined such standards will minimize the risk of “serious adverse health consequences". The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention and risk-based food safety standards.
This chapter summarizes the evolution of science-based risk control systems into food regulation in the United States beginning with the development of HACCP and finishing with enactment the Food Safety Modernization Act in 2011. Key points of the HACCP regulation for seafood, meats and poultry, juices, and FSMA risk-control plans are covered. Finally, the chapter provides advice on compliance with these control systems.
Once more, while facing an analogous risk phenomenon affecting their predominantly homogeneous societal and economic interests, the US and EU authorities seem to adopt diverging stances. Amid the publication of several new studies and a set of EFSA scientific opinions linking the use of the world’s most widely used pesticides to bee decline, the European Union is poised to adopt a temporary ban on their use. While the Commission does not expressly rely on it, its restrictive decision is clearly based on the controversial precautionary principle. Yet, as it is discussed in this article, the conformity of this decision with the requirements that determine the legal invocation of this principle remains doubtful.
This article proceeds as follow. Part II first introduces the reader to the main features and usages of these controversial insecticides, called neonicotinoids. It then discusses how concerns have arisen around their use and analyses the available science exploring their impact on the sudden decline of bee colonies. Part III identifies and comments the restrictive actions currently undertaken across the European Union both at the national and EU level. Part IV in turn provides an overview of the scientific and regulatory approaches adopted by US authorities vis-à-vis neonicotinoids. By building upon the previous two sections, Part V contrasts the EU scientific and regulatory approach towards the use of these pesticides with that adopted by the US authorities. It then attempts at illustrating the factors explaining the current regulatory divergence across the Atlantic upon the issue of neonicotinoids. In order to provide a legal analysis of the EU restrictive stance over these pesticides, Part VI measures how the EU controversial restrictive measures score under both EU and WTO law. Lastly, some final conclusions provide some recommendations on how to render less controversial the invocation of the precautionary principle in the EU and beyond.
National Meat Ass’n v. Harris is poised to become a significant legal barrier to industrial animal agriculture reform. Although Congress has historically refrained from setting even minimal protections for animals raised in industrial operations, the Supreme Court’s 2012 opinion laid the foundation for expanding Congress’s Commerce Clause authority to set national limits to state animal welfare standards. National Meat asked whether USDA slaughterhouse and packing plant regulations under the Federal Meat Inspection Act preempted California’s newly-raised standards for handling disabled (or “downed”) livestock. In answering this question, the Court misconstrued federal legislative and regulatory history and improperly conflated the state’s animal cruelty regulations with its food safety regulations and the USDA’s food safety regulations. Taking the resulting opinion to its logical conclusion, Congress and the USDA have unprecedented supremacy to limit state farmed animal welfare and anti-cruelty standards. This unfortunate consequence might have been avoided had National Meat asked a better question: Whether California’s welfare standards for downed livestock violated the “dormant” Commerce Clause. Mounting tensions between meat and dairy corporations and organizations representing animal welfare, food safety, and consumer protection interests will eventually force congressional action. Unless its preemptive authority in the area of farmed animal welfare is correctly defined, Congress will continue to impose artificial limits on state police authority to define what is “humane.”
This paper traces the historical evolution of a view of consumers as informed, rational, and rights-bearing decision makers, and the corresponding diminution of FDA’s role as a paternalistic gatekeeper acting in conjunction with medical and scientific experts to prevent products and information from reaching the public.
The relationship between consumers and FDA-regulated products has changed dramatically since the mid-1960s. A half century ago, FDA treated consumers as passive and ignorant. Accordingly, the agency gave them relatively little latitude to make their own choices among products and denied them much of the information they could have used to inform such choices. By comparison, today’s consumers of food and drugs are much more empowered to make their own, unmediated choices among a wider variety of products, guided by a deluge of labeling and advertising information.
The paper examines this phenomenon against a background of three societal and cultural trends during the past half century: Americans’ declining trust in major institutions, the “rights revolution,” and the dramatic expansion of health care information accessible to consumers. It then examines a variety of specific regulatory developments during this period of change. In a section on food, the paper considers reforms in standards of identity and nutrition labeling, the rise of health claims as facilitated by the First Amendment, and various popular movements for freedom of choice with respect to food ingredients and dietary supplements. The paper then turns to drug regulation, examining the rise of patient labeling and direct-to-consumer advertising of prescription drugs, the tidal wave of “switches” from prescription to over-the-counter status, and the birth of social movements seeking to influence FDA drug approval policy. The paper concludes by speculating on whether this new model of consumer is a permanent one.
Fifty million people in the U.S.—one in four children—don’t know where their next meal is coming from. Directors Kristi Jacobson and Lori Silverbush examine the issue of hunger in America through the lens of three people struggling with food insecurity: Barbie, a single Philadelphia mother who grew up in poverty and is trying to provide a better life for her two kids; Rosie, a Colorado fifth-grader who often has to depend on friends and neighbors to feed her and has trouble concentrating in school; and Tremonica, a Mississippi second-grader whose asthma and health issues are exacerbated by the largely empty calories her hardworking mother can afford.
Ultimately, A Place at the Table shows us how hunger poses serious economic, social and cultural implications for our nation, and that it could be solved once and for all, if the American public decides — as they have in the past — that making healthy food available and affordable is in the best interest of us all.
Although the current horsemeat scandal has been depicted as an instance of fraud and mislabeling generated by a single source, it is progressively escalating into a broader food safety crisis that reveals some flaws in our EU food safety system. Yet relying on country-of-origin-labelling – as many have invoked it – to tackle misleading labeling of food ingredients might be the wrong answer to the good question raised by this unfortunate story. . . .Alberto reviews facts and the timeline of events in the scandal and then provides an analysis that identifies the flaws of the current EU regulatory framework and provides some recommendations.
Penicillins and tetracyclines sold for animal use increased for the second year in a row. From 11.5 million pounds in 2009, sales rose to 14.4 million pounds in 2011. The two classes of antibiotics remain the most commonly used antibiotics in livestock and poultry, despite their obvious import for treating infections in people as well. In 2011, animal sales accounted for 38 percent of total penicillin sales and 98 percent of total tetracycline sales, including in humans.One of the concerns about the overuse of antibiotics in livestock production is that we are encouraging the development of antibiotic resistant strains of dangerous bacteria. This is where the study of antimicrobial resistance in retail meat is important. Summarizing the NARMS report, Helena Bottemiller noted that:
Drug resistance among Salmonella isolates increased all around. In 2010, the percentage of isolates that showed drug resistance was about 50 percent, while in 2011 it had increased to nearly 55 percent.
Resistance to cephalosporins, a class of drugs the FDA restricted in early 2012, increased between 2002 and 2011. Third generation cephalosporin resistance increased, in chicken from 10 to 33 percent and in ground turkey from 8 to 22 percent. . . .
The NARMS data also indicate that there was a significant increase in ampicillin resistance over the last decade among retail chicken, from nearly 17 percent to around 40 percent, and in ground turkey isolates from 16 percent to 58 percent. Ampicillin can be used in human medicine to treat infections, including Salmonella.
More than 27 percent of all chicken isolates showed resistance to five or more classes of antibiotics and in ground turkey isolates researchers found 10 different serotypes with resistance to six or more classes of antibiotics.The Animal Health Institute, the lobbying organization for the veterinary pharmaceutical companies has not commented on the recent reports, but has consistently maintained that "[a]nimal antibiotics make our food supply safer and people healthier. Antibiotics are a critical tool to prevent, control and treat disease in animals. In doing so, they also reduce the chance of bacterial transmission from animals to humans." While antibiotics are clearly needed in animal production for the treatment of disease, the data indicates that their continual use in feed as a disease prevention method and to promote rapid growth is problematic.
