From Farming to "Pharming". Risks and Policy Challenges of Third Generation GM Crops

Commercial and academic activities in the production of pharmaceuticals or other substances of industrial interests from genetically modified plants, i.e. molecular farming, have so far centred in the USA and Canada. Recent increases in EU activities and the proximity to market stage of the first plant-made pharmaceuticals, some of which from EU based companies, represent a call to action for EU regulators. Drawing on the North American debate on molecular farming it will be argued that both the rationale of and the risk issues associated with molecular farming will differ significantly from those of first generation GM crops. Based on these differences, the suitability of the existing regulatory framework, which essentially was developed in response to the arrival of insecticide and herbicide tolerant crops for food and feed use, is discussed. Possible options for adapting the already complex EU regulatory system to cater for molecular farming are examined. It will be argued that the policy challenges posed will inevitably spark a broader public debate. As an issue for debate, molecular farming is located at two crossroads: of the risk debate on agricultural biotechnology and the sustainability debate on renewables and greening of industry and of red and green biotechnology. Complex scientific, technical and legal issues, new issues at stake and a new pattern of actors are likely to give EU regulators a difficult time.molecular farming, industrial crops, biotechnology policy, risk assessment, GMO regulation

The Bioterrorism Act of the USA and international food trade: Evaluating WTO conformity and effects on bilateral imports

The September 11th event focused the world's attention on the threat of bioterrorism to the food chain. As a consequence, the U.S. implemented the Bioterrorism Act (BTA). These new administrative import rules will be evaluated regarding WTO conformity and trade impact. This analysis is based on an inventory approach systematizing the BTA, and a trade flow analysis. The BTA do not significantly deviate from WTO rules, however, the findings are driven by existing flexibility in international administrative import guidelines. The trade analysis highlights that products and countries with prior expedited or less regulated procedures and small import quantities are affected.Food Consumption/Nutrition/Food Safety, International Relations/Trade,

Fixing Food Safety: Protecting America's Food Supply From Farm-to-Fork

Provides an overview of the major concerns regarding U.S. food safety, including an ineffective regulatory system, and of food-borne disease threats. Includes lists of recent outbreaks, major causes of food-borne illnesses, and recommended solutions

After Heparin: Protecting Consumers From the Risks of Substandard and Counterfeit Drugs

Based on case studies, examines globalization and quality management trends in pharmaceutical manufacturing, barriers to Federal Drug Administration oversight, and the security of pharmaceutical distribution. Makes policy recommendations to ensure safety

The Bioterrorism Act of the USA and international food trade: evaluating WTO conformity and effects on bilateral imports

The September 11th event focused the world’s attention on the threat of bioterrorism on the food chain. As a consequence, the USA implemented the Bioterrorism Act (BTA) containing new import requirements that can be classified as non-tariff barriers (NTBs). This paper analyses these NTBs by performing an assessment of WTO conformity and trade impact: hereby general problems in the analysis of bioterrorist risks are explored as for this new and unknown threat explicit WTO rules are still missing. Additionally, in exploring the BTA relevant process standard rules laid out by the WTO, the analysis indicates the extensive flexibility provided in this framework. This leads to larger scope for national polices on process standards compared to product standards (e.g. residua levels). The empirical trade flow analysis illustrates differences in the compliance costs between countries. This differentiation can be caused by learning costs that may differ among countries. The analysis highlights that perishable products and countries with small import quantities are mostly affected.food terrorism, non-tariff barriers, trade facilitation, Bioterrorism Act, international food trade, SPS Agreement, International Relations/Trade,

Management of chemical and biological risks in agri-food chain

Paper presents diverse modes of governance of chemical and biological risks in agri-food sector, assesses their efficiency, complementarities, and challenges, and suggests recommendations for public policies improvement. It defines governance as system of social order responsible for particular behavior of agents; specify various (institutions, market, private, public) mechanisms of risk governance and (natural, technological, behavioral etc.) factors of efficiency; and suggest a framework for analysis and improvement of risk governance. New opportunities for risks governance relate to: modernization of technologies and institutional environment; specialization, concentration, and integration; “willingness to pay” and consumers and media involvement; national and transnational cooperation. Risk management challenges are associated with: new threats and risks; separation of risk-creation from risk-taking; vulnerability of mass production, distribution and consumption; high adaptation and compliance costs; unequal norms, implementing capability, policies and private strategies; public failures; and informal sector. Policies improvement is to incorporate governance issues taking into account type of threats and risks, specific factors, and comparative benefits and cost (including third-party, transacting, time); employ more hybrid modes introducing and enforcing new rights, and supporting private and collective initiatives; give greater support to multidisciplinary and interdisciplinary research on factors, modes, and impacts of risk-governance.risk management; market, private, public governance; agri-food chain

Resilience of food companies to calamities - perceptions in the Netherlands

Calamities such as extreme droughts and trade or infrastructure breakdowns potentially hamper the continuity of individual food companies, as well as the continuity of food supply in Europe at large. There is a lack of insight into food companies’ resilience in case of cumulative calamities or calamities that did not happen before in recent history. In this context, an expert elicitation study among feed and food companies in the Netherlands was undertaken. Results show that lengthy or structural unavailability of electricity and a lengthy crisis of road transport are perceived as the most threatening calamities.Outcomes also show a relatively limited implementation of BCM (business continuity management) at company level. Complete BCM programs for top-3 calamities perceived to threaten the continuity of food supply in Europe are reported by 0% to 30% of the companies. For calamities perceived to be important for business continuity this is between 20% and 40%. In the field of risk management a leading role is attributed to the public sector for improving international governance and setting up a so-called masterplan with measures such as larger raw-materials stocks and broad sourcing. Findings suggest that further actions are needed, starting with prioritised calamities and the design of a masterplan. Yet, stakeholders are also urged to pro-actively “think the unthinkable

Title III of the Bioterrorism Act: Sacrificing U.S. Trade Relations in the Name of Food Security

Part I examines in detail the two conflicting laws that are the basis of this Comment—Title III of the Bioterrorism Act and the SPS Agreement—focusing on those portions of Title III that adversely impact international trade. Part I also presents the WTO case EC Measures Concerning Meat and Meat Products (Hormones), the first food regulation case disputed in the WTO system for a violation of the SPS Agreement. This case clarified the two major principles of the SPS Agreement that are explored in this Comment: the prohibition on discrimination and the obligation to support trade–restrictive measures with an analytical risk assessment. As such, it will be used as a tool to explain these principles and illustrate how a WTO member could successfully dispute Title III’s compliance with the SPS Agreement. Part II of this Comment analyzes Title III’s conformity with the SPS Agreement. This Part establishes that Title III is subject to the SPS Agreement because it is a sanitary measure designed to protect human life and health from the threat of deliberate food contamination. Part II then argues that, while motivated by the real threat of bioterrorism, Title III nonetheless violates the nondiscrimination principle of Article 2.3 of the SPS Agreement by discriminating against foreign imports. Part II also argues that Title III violates Article 5 of the SPS Agreement because it is a trade restrictive regulation that is not based on a supportive risk assessment. Finally, Part II asserts that, because Title III exempts a large number of direct-to-consumer food sources from its administration, its overall ability to provide bioterrorism protection is significantly diminished. This presents the question: if Title III fails to achieve its stated purpose, can it ever comply with the risk assessment principle of the Agreement? Part III concludes that Title III of the Bioterrorism Act violates two key provisions of the SPS Agreement. Because the Bioterrorism Act as written specifically requires the trade-restrictive measures in question, Title III should be rejected in its entirety to remain consistent with U.S. trade obligations under the WTO. This Part then evaluates the implications of Title III’s breach of the SPS Agreement. If the United States retains the measure, it risks an adverse decision from the dispute settlement system of the WTO. In closing, Part III recommends that the United States collaborate with international trading partners in the future to achieve a global bioterrorism solution that is sensitive to trade considerations