Saturday, July 13, 2013

New Food Safety Chapters

Food Law Prof Neal D. Fortin published two chapters in two different books this spring. Both relate to the complex issue of the regulation of imported food. Although I do not have links, citations to the books are provided.

Neal Fortin, Institute for Food Laws & Regulations, Michigan State University, Michigan State University College of Law

Improving U.S. Regulation of Imported Foods, Improving Import Food Safety, pp. 89-109 (Wiley-Blackwell 2013)    
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.

Neal D. Fortin, Institute for Food Laws & Regulations, Michigan State University, Michigan State University College of Law

HACCP and Other Regulatory Approaches to Prevention of Foodborne Diseases, Foodborne Infections and Intoxications, Chapter 38, 4 Ed. (Elsevier 2013)
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. 

The Science, Law and Policy of Neonicotinoids and Bees: A New Test Case for the Precautionary Principle

Another article that is on my summer reading list is the very timely article by Food Law Prof Alberto Alemanno discussing the precautionary principle and the regulation of neonicotinoids.

Alberto Alemanno, HEC Paris - Law Department
The Science, Law and Policy of Neonicotinoids and Bees: A New Test Case for the Precautionary Principle,  European Journal of Risk Regulation, 2/2013

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.

Preempting Humanity: Why National Meat Ass'n v. Harris Answered the Wrong Question

I also recommend the following thought-provoking article by Food Law Prof Pamela Vesiland. I am pleased to note that Pamela has agreed to stay with us for another year at the University of Arkansas School of Law, serving as a Visiting Assistant Professor. Pamela earned her LL.M. degree in Agricultural & Food Law in May.

Pamela Vesiland, Preempting Humanity: Why National Meat Ass'n v. Harris Answered the Wrong Question, 65 Me. L. Rev. 685 (2013).
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.”

FDA and the Rise of the Empowered Consumer

I 'd like to highlight some of the articles that our Food Law Professors group are publishing. As member Alberto Alemanno is the editor of the LSN, Food Law & Policy eJournal, his listings are a good way to start. I noticed Lewis Grossman's recent article, described and linked below, and it is now on my "must read list" for the summer.

Note:  it would be wonderful if listserv members would either post themselves or send me titles and abstracts of your recent work for posting. Otherwise, it will just be the articles that I happen across and recommend.

FDA and the Rise of the Empowered Consumer
By Lewis A. Grossman, American University

Presented to the Harvard Law School Petrie Flom Health Law Center Annual Conference: FDA in the 21st Century
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.