Testing Potential Fish Fraud in Community-Supported Fisheries

The seafood industry has long been plagued by the substitution of a species under a false label. Seafood mislabeling is a major concern in the management of fish and marine species. Incorrect labels hamper the ability to estimate stock size effectively, reduce consumer choice, and represent potential health hazards. The rates of seafood fraudulence have been shown to differ across businesses and markets, and in recent years, community-supported fishery programs (CSFs) have sprung up as an alternative to fish markets and grocery stores. Using genetic analysis, I show that 17 out of 41 (41.5%) samples examined from multiple markets in New Hampshire and Maine were fraudulent. The rates of fraudulent labeling differed across species and across markets, with community-supported fishery programs having the lowest levels of fraud (3 out of 10 samples, 30%) followed by restaurants (33%), fish markets (44%), sushi restaurants (50%) and grocery stores (58%). While the different levels of fraudulence between CSFs and other markets were not found to be statistically significant (p=0.36), my findings should warrant future studies with a larger sample of CSFs to determine the extent to which CSFs can help reduce seafood fraudulence

Auditing: Active Learning with Outcome-Dependent Query Costs

We propose a learning setting in which unlabeled data is free, and the cost of a label depends on its value, which is not known in advance. We study binary classification in an extreme case, where the algorithm only pays for negative labels. Our motivation are applications such as fraud detection, in which investigating an honest transaction should be avoided if possible. We term the setting auditing, and consider the auditing complexity of an algorithm: the number of negative labels the algorithm requires in order to learn a hypothesis with low relative error. We design auditing algorithms for simple hypothesis classes (thresholds and rectangles), and show that with these algorithms, the auditing complexity can be significantly lower than the active label complexity. We also discuss a general competitive approach for auditing and possible modifications to the framework.Comment: Corrections in section

Punishing Pharmaceutical Companies for Unlawful Promotion of Approved Drugs: Why the False Claims Act is the Wrong Rx

This article criticizes the shift in focus from correction and compliance to punishment of pharmaceutical companies allegedly violating the Food, Drug, & Cosmetic Act (FD&C Act) prohibitions on unlawful drug promotion. Traditionally, the Food and Drug Administration (FDA) has addressed unlawful promotional activities under the misbranding and new drug provisions of the FD&C Act. Recently though, the Justice Department (DOJ) has expanded the purview of the False Claims Act to include the same allegedly unlawful behavior on the theory that unlawful promotion “induces” physicians to prescribe drugs that result in the filing of false claims for reimbursement. Unchecked and unchallenged, the DOJ has negotiated criminal and civil settlements with individual pharmaceutical companies ranging from just under ten to hundreds of millions of dollars. In part, companies settle these cases to avoid the potential loss of revenue associated with the exclusion regime administered by the U.S. Department of Health and Human Services, under which companies risk losing the right to participate in federal health care programs. Even more disturbing, these settlements allow DOJ to circumvent judicial review of its enforcement approach, preventing any type of accountability for its legal theories or procedures. This article discusses the traditional enforcement methods employed by the FDA as well as the more recent DOJ prosecutions under the False Claims Act. Although it concludes that the FD&C Act should provide the sole means for prosecuting unlawful drug promotion, it also suggests that when prosecuting pharmaceutical companies under either Act, the government must avoid the temptation to mine companies for large settlements in lieu of developing a more coherent and responsible enforcement strategy

FDA Preemption of State Tort Law in Drug Regulation: Finding the Sweet Spot

The project of harmonizing tort law and regulatory law in the public interest-the sweet spot of my subtitle-is inherently fraught with difficulty. This, of course, is a very old problem for American law generally. Our administrative state began during the first decade of the Republic. Beacause energetic administration has always created risks of harm to persons and property, the potential for overlap and conflict with the hoary common law of torts. which likewise protects persons and property, has always been an inevitable consequence of regulatory statutes. Moreover, as Richard Nagareda explains, recent developments in both tort law and administrative regulation increasingly cast the two less as complementary regimes than as institutional rivals

The European Regulatory Framework and its implementation in influencing organic inspection and certification systems in the EU

The report presents a review of the most important European and international legislation that set the framework for organic certification, of reports prepared by international agencies working with organic standard setting and certification, and of relevant scientific literature. It discusses problems, future challenges of the organic control systems in Europe leading to suggestions for improvement. Food quality assurance is of key importance for the future development of the Common Agricultural Policy of the EU. A large number of mandatory and voluntary assurance and certification schemes exist for agriculture and in the food industry leading to the risk of increased costs for producers and confusion of consumers. Such schemes include the setting of requirements and bodies that undertake control and provide certificates. Requirements can be divided into statutory regulations regarding food safety and good agricultural practice and standards for voluntary attributes. Basic requirements of food safety, animal health and animal welfare are controlled by the Official Food and Feed Control (OFFC) systems, governed by Council Regulation (EC) 882/2004. Third party certification provides credibility to claims related to voluntary standards and is communicated to the consumers through the use of certification marks. The EU has developed a legislative basis for quality claims in relation to geographical indications, traditional specialities and organic farming and considers introducing labelling rules in relation to animal welfare, environmental impact and the origin of raw materials. Organic certification is one of a number of overlapping and competing schemes. The development of organic standards and certification in Europe started with private standards and national rules, leading to Regulation (EEC) 2092/1991. The requirements for competent authorities, control bodies and operators in this regulation regarding the control systems are reviewed. The discussion highlights the low level of knowledge among consumers of the requirements of organic certification, a weak emphasis of the control system on operator responsibility for organic integrity, issues of competition and surveillance of control bodies, a lack of consideration of risk factors in designing the inspection systems and a lack of transparency. A total revision of the European Regulations on organic production began in 2005. One important change introduced by the new Council Regulation (EC) 834/2007 for Organic Food and Farming is that the organic control system is placed under the umbrella of Council Regulation (EC) 882/2004 on Official Food and Feed Controls. Regulation (EC) 834/2007 also requires that control bodies have to be accredited according to general requirements for bodies operating product certification systems (ISO Guide 65/EN 45011). From July 2010 packaged organic products will have to carry the new EU logo as well as the compulsory indication of the control body. The report reviews the requirements for competent authorities, control bodies and operators from the various legal sources. The discussion highlights a lack of clarity on the impact of the OFFC regulation on the organic control system including how risk based inspections are to be implemented and the potential for in-consistencies in the enforcement of the regulation. A number of international initiatives concerned with the harmonisation of organic standards and to a lesser extent certification are reviewed, such as the International Task Force on Harmonisation and Equivalence (ITF)1 Two main alternative guarantee systems for organic production have been developed and researched by a number of organisations including IFOAM, ISEAL, FAO and the EU Commission. Smallholder Group Certification based on an Internal Control System (ICS) and Participatory Guarantee Systems (PGS) could also represent ways to minimize certification costs also for European farmers, in particular for operators that market directly or through very short supply chains. Both systems also illustrate examples of certification systems with a focus on system development and improvement. , the European Organic Certifiers Council (EOOC), the International Social and Environmental Accreditation and Labelling Alliance (ISEAL) and the Anti-Fraud Initiative (AFI). The multilateral initiatives have led to a better understanding of current problems and the scope and limitations for harmonisation. They have also contributed to the sharing of tools and methods and the identification of best practice. Apart from organic farming the European Union has two other food quality schemes: Regulation (EC) 510/2006 on geographical indications and Regulation (EC) 509/2006 on traditional specialities. The report explores the potential for combining these with organic certification, and draws lessons for organic certification based on Italian experience. The final chapter summarises problems and challenges from the previous chapters. Suggestions for improvements of the organic control system focus on two issues: the need for further harmonisation of the surveillance of control bodies and enforcement of the regulation and how operators’ responsibility for further development of organic systems could be supported in the control and certification system