The Failure of Federal Biotechnology Regulation

The recent court case and state ballot measures regarding mandatory labels for Genetically Modified Organisms (“GMOs”) suggest the need for a deeper conversation about the federal framework for regulating biotechnology. What is it about GMOs that consumers feel they have the “right to know?” Why has a generation of federal biotechnology regulation failed to satisfy consumer concerns? Are those concerns irrational, or is the regulatory structure inadequate? This Article argues that many consumer concerns underlying the labeling movement raise important scientific and extra- scientific questions that have been apparent since the advent of the technology in the 1980s. Moreover, these concerns persist because the Coordinated Framework for Regulation of Biotechnology has failed to respond to them effectively. The Coordinated Framework was based on statutes that pre-existed the technology and thus poorly fit the unique risks of genetic engineering. Today, genetic engineering is on the verge of a radical shift in technology, a shift that has already begun to burst the seams of those old statutes, leaving agencies with no regulatory authority at all over new products. This Article reviews the evidence behind persistent concerns about GMOs, considers the failures of the Coordinated Framework to address the most valid of those concerns, and canvasses policy questions that Congress must consider to more effectively tailor agency authority to address the risks and to enhance the potential of this rapidly-changing field of technology

A Window of Opportunity for GMO Regulation: Achieving Food Integrity Through Cap-and-Trade Models from Climate Policy for GMO Regulation

GMOs are the links of our centralized food system, largely dependent on international trade. GMOs are inherently unsustainable because they reduce biodiversity, harm the environment, and empower positive feedback loops between monocultures, industrial agriculture, and biodiversity depletion, thereby jeopardizing food safety, security, and sovereignty. Conglomerates of multi-national companies, in short BigAg, shape multi-lateral food trade and flood international markets with their small array and enormous volumes of crops, while controlling large aspects of agriculture and food production world-wide. Zooming in on the trans-Atlantic dispute about GE crops, this paper uses comparative law to explore how a cap-and-trade model borrowed from climate change policy might help to decentralize the current food system, thereby potentially restoring locally-oriented agriculture and food integrity. GMOs are under-regulated in the US and international trade frameworks enable the centralization of trans-Atlantic food systems, dominated by the US. This is possible because of the free trade/biotechnology policy in the US and the agricultural exceptionalism, which are, in theory, obstacles to food integrity. By comparison, the precautionary and protectionist approaches in the EU facilitate some food integrity, albeit not enough as a result of US trade pressures. The pressures could be partially lifted if there were a cap on those crops that enable the centralization of the system, namely GE crops patented and produced by US-American BigAg conglomerates. Essentially, when GE corn, soy, wheat, rice were capped in permissible trade volumes, other non-GE crops may enter the market, thereby diversifying and decentralizing food systems, encouraging local agriculture, and opening pathways where more sustainable practices could be instituted. In an effort to contextualize the herein proposed cap-and-trade upstream model regulation of GMOs borrowed from climate change policy, this paper explains the distinctions between GE and conventionally bred crops, between agriculture and food law, between the US free trade and the EU protectionism approaches (including the bedrocks of each legal framework) to trading GE crops, as well as the inherent dangers of the widespread use of GMOs in the trans-Atlantic food system. A likely conclusion of this paper will be that a cap-and-trade model, as proposed, may take decades to be passed into law, if ever, but it also highlights that the links between preserving food integrity, mitigating climate change, and maintaining open food trade are ripe for progressive and pro-active review

International liability and redress for genetically modified organisms and challenge for China's biosafety regulation

The UN Cartagena Protocol on Biosafety (Biosafety Protocol) is an international instrument addressing the potential environment and health issues of Genetically Modified Organisms (GMOs). Its article 27 on Liability and Redress, which finally has been explored as a new treaty "Nagoya-Kuala Lumpur Supplementary Protocol" (Supplementary Protocol) was recently adopted in October 2010. The new Protocol chose an administrative approach instead of an international civil liability regime, and left the implementation to the discretion of competent national authorities of the parties as rather a "national approach". As a party to the Biosafety Protocol, China might take the Supplementary Protocol into account for its own biosafety regime. The interplay between the Biosafety Protocol (and the Supplementary Protocol) with China's national biosafety regime will be briefly examined in this paper. It argues that a comprehensive biosafety law will be needed to oversee the import and export of GMOs, as well as efficiently manage cultivation of GM crops within China. The paper concludes that the inclusion of a liability clause into the biosafety law seems necessary for China's obligation to the Biosafety protocol to deal with the uncertainties of GMOs, thereby ensuring the sustainable development of biotechnology

The Failure of Federal Biotechnology Regulation

The recent court case and state ballot measures regarding mandatory labels for Genetically Modified Organisms (“GMOs”) suggest the need for a deeper conversation about the federal framework for regulating biotechnology. What is it about GMOs that consumers feel they have the “right to know?” Why has a generation of federal biotechnology regulation failed to satisfy consumer concerns? Are those concerns irrational, or is the regulatory structure inadequate? This Article argues that many consumer concerns underlying the labeling movement raise important scientific and extra- scientific questions that have been apparent since the advent of the technology in the 1980s. Moreover, these concerns persist because the Coordinated Framework for Regulation of Biotechnology has failed to respond to them effectively. The Coordinated Framework was based on statutes that pre-existed the technology and thus poorly fit the unique risks of genetic engineering. Today, genetic engineering is on the verge of a radical shift in technology, a shift that has already begun to burst the seams of those old statutes, leaving agencies with no regulatory authority at all over new products. This Article reviews the evidence behind persistent concerns about GMOs, considers the failures of the Coordinated Framework to address the most valid of those concerns, and canvasses policy questions that Congress must consider to more effectively tailor agency authority to address the risks and to enhance the potential of this rapidly-changing field of technology

A Comparative Study of GMO Labeling and Liability Systems in the US, EU, and South Korea: The Circumstances and a Future Potential for Harmonization

With the remarkable development of GMOs, GMO trade has also increased. The different attitudes on GMOs among the countries all over the world, specifically the US, EU, and South Korea, have the potential to create international trade conflicts. In order to mediate the conflicts, reasonable labeling and liability systems need to be established to prevent potential GMO risks. The Biosafety Protocol regarding the transboundary movement of GMOs exists to resolve such tensions, but it fails to sufficiently solve the problems and provide clear regulations concerning GMO labeling and liability systems. A successful GMO labeling and liability system should emphasize the precautionary principle and use a cooperative approach that considers all views on GMOs. After reviewing current international and domestic standards, particularly the ones in South Korea, the GMO labeling system should be mandatory, supporting the consumer\u27s right to know. Additionally, the new GMO liability system should reflect a civil liability system, where standards protect the party injured by GMOs in the direction of compensating the damage fully and efficiently by using the precautionary principle

Prospects of genetic modified maize crop in Africa

Genetic modified maize crop increases annually as a result of food insecurity and limited land caused by rapid population increase of over seven billion in the world. Scientists have been playing their role to address this food insecurity problem. The use of genetically modified (GM) maize crop to feed people is one of the proposed ways, because it yields more compared to the conventional varieties. However, there are several contradictions which hinder the adoption of this new technology. Some studies have shown that GM maize is risky to human health, animals and not friendly to environmental conservation, which may lead to the death of other bio-diversities. Generally, other studies have supported the consumption of GM maize. However, after being approved by the scientist in the countries concerned, the GM maize varieties which seem to be hazardous to human health must be prohibited in research centres so as to avoid transportation to other countries. Regarding the new technology of GM maize, the conventional method of breeding is still important to keep maize seeds available in the gene bank. Therefore, researchers should consider this for further research issues on maize improvement.Key words: Bacillus thuringensis-maize, Bacillus thuringensis protein, conventional breeding, environment, food crisis, genetic modified maize, genetic modified organism, health risk, landraces

More Sorry than Safe: Assessing the Precautionary Principle and the Proposed International Biosafety Protocol

Part I of this paper provides a brief overview of the development of biotechnology, its regulation and its use, with a particular emphasis on agricultural biotechnology. Part II outlines the United Nations Convention on Biological Diversity, which provides an international legal framework for a biosafety protocol and summarizes the results of recent protocol negotiations, such as those conducted in Cartagena, Colombia in February 1999, which continued in Montreal in January 2000. Part III explains why the proposed protocol embodies a variant of the precautionary principle and why such policies may do more harm than good. This paper concludes with some brief thoughts on how to approach the potential and uncertain risks and benefits of new technologies in general and of biotechnology in particular