Genetic Technology and Food Safety

In 2013 and 2014, no GM plants were released into the environment in Germany, neither for research nor for commercial purposes. Political as well as legal grounds may have contributed to this development. In fact, the German public tends to be much more critical about agricultural biotechnology than the EU average. Politicians seem to have bowed to the public’s distrust against GMOs. Both the executive and the legislature have exercised almost any margin of discretion left by EU law to the Member States in order to strangle GM plant cultivation. Examples include the Federal Ministry of Agriculture’s order suspending the cultivation of the GM variety MON810 and strict liability provisions which prompted the German Farmers’ Association to advise every farmer against GM crop cultivation.

The Belgian regulations for GMOs are to a large extent dictated by the EU regulatory framework for GMOs. The implementation of the relevant European Directives concerning GMOs and the application of the related Regulations is a mixed competence between the regions and the Federal Government. The implementation of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, is a task for the federal authorities in as far as it deals with the “placing on the market of genetically modified organisms as or in products within the Community”. The regional authorities are involved as far as it deals also with “carrying out the deliberate release into the environment of genetically modified organisms for any other purposes than placing on the market”. Regional competencies are e.g. involved in the authorisation of field experiments, because there may be risks to their environment and biodiversity. The implementation of Directive 2009/41/EC on the contained use of genetically modified micro-organisms is mainly a competence of the regions, because the laboratories in which these activities take place are seen as so-called “classified installations” that require a regional environmental permit. The decisions made by different administrative bodies are based on a common scientific evaluation system comprising the Biosafety Advisory Council (BAC) and the Biosafety and Biotechnology Unit (SBB), based on the Cooperation Agreement of 25 April 1997 between the Federal State and the Regions on the administrative and scientific coordination concerning biosafety.

The article presents the basic principles and laws in relation to the legislation on food, especially genetically modified food (GMO) and foodstuff. The general Food Act has enacted provisions which apply also to GMO food. Some additional requirements are introduced in the Act on Gene Technology; this Act, however, does not contain any food-specific provisions others than labelling of products. International food obligations and the food legislation of the European Union is directly applicable and referred to in national law as binding legal sources. Finland has not created GMO free zones; on the other hand there are GMO cultivations on an experimental basis only.

This chapter examines the legal framework applicable to genetically modified organisms (GMOs) in Ireland, bearing in mind the limited presence of GMOs. Overall, Ireland holds varying stances to different forms of GMOs, with the greatest acceptance and use of GM-feed for pragmatic reasons. It has not developed a specific Irish approach, instead copy-pasting EU legislation and relying upon existing law to deal with any issues. This is understandable in light of the high level of harmonization and limited presence of GMOs in Ireland, but nonetheless will need to be developed as the availability of GMOs increases.

Italy belongs to the European Union, therefore European rules concerning GMO have been applied in Italy. In particular, Regulation No. 1829/2003 requires that no-one can introduce a GMO destined for human consumption into the market unless both authorisation has been granted for the product and the conditions of the authorisation are respected. Italian public opinion fully shares EU worries about GMOs and the Government has been the mouthpiece for concerned citizens in two cases: in 2000, on a cautionary basis a decree suspended the marketing and utilisation of three Monsanto transgenic maize products; in 2013, a decree banned the cultivation of MON810 maize varieties deriving from genetically modified seed all over Italy. The formulation and implementation of government policies pertaining to certain subjects – as in the case of GMOs – involve complex interaction between scientific and technological questions. Therefore the juridical bodies entrusted with drawing up the legal aspects of the rules often need to consult with scientific experts who are in possession of in-depth knowledge on the subject, or they may need to call upon advanced technical analyses. On the basis of the information thereby acquired, one of the distinct opinions on the matter at hand will be selected, and will thus become the legally binding rule.

In contrast to the technocratic character of many of the current Community rules, there is a desire for greater openness of the decision-making processes to all components of society. This would allow a broader base of opinion to make a contribution to formation of the rules and to an improvement in the quality of the decisions. In other words, the overall framework of the European Union is experiencing a demand for critical revision of the system of European governance, in the direction of its democratisation.

The Norwegian Gene Technology Act stands out by specifying five concerns. It requires that the gene technology shall not be harmful for human health and the environment, but additionally that deliberate release of genetically modified organisms (GMOs) shall be of benefit to society, ethically justifiable and socially acceptable, and is likely to promote sustainable development. As a member of the European Economic Area (EEA), Norway is in general bound to implement EU directives, but according to EEA Agreement Annex XX (Environment), Article 25.d(c) Norway can apply national legislation relating to GMOs for other concerns than health and environment. The restrictive approach implies that until 2015 no GMOs have been accepted in Norway, but assessments of EU-approved GMOs are under way. While human rights is neither specified in the Gene Technology Act or the Food Act, nor in the constitution, Norway’s general policies confirms the right to food.

In Switzerland, genetic engineering remains a controversial issue. In 1992, an amendment of the Federal Constitution (article 120 FC) added substantial directives to regulate genetic engineering: misuse of gene technology is prohibited and the dignity of living beings must be respected. With regard to the regulation of genetically modified foodstuffs some additional legislation has to be taken into consideration: Article 118 FC (protection of human and animal health) and Article 74 (protection of the environment) as well as several international treaties including agreements between Switzerland and the European Union. The Gene Technology Act (GTA) and the Foodstuff Act (FSA) implement material requirements on safety, on the protection of dignity of living beings, on coexistence including provisions on labelling, on the product flow segregation and on liability, as well as procedural requirements with regard to authorization procedures including the right of appeal. Further concretisations are implemented in several ordinances. Worth mentioning is the moratorium with regard to marketing of GMO, effective until the end of 2017, which, however, does not touch research.

Genetic technology has produced new varieties of crops, primarily corn, soy, and cotton, that resist insects and tolerate herbicides. Many producers in the United States have cultivated genetically modified crops, and in 2014, GM crops were grown on millions of hectares in 28 countries. Legal requirements for authorization in the United States, implemented by the US Department of Agriculture, Environmental Protection Agency, and Food and Drug Administration, are designed to ensure that genetically modified crops are safe to grow, safe for the environment, and safe to eat. GM crops have raised significant issues: labeling, not currently required in the US; liability for possible damage caused by cultivation and sale; and regulatory barriers and asynchronous approvals. In light of current food insecurity, the growing world population, and the uncertainties of climate change, GM crops may help to satisfy global food demands.

Genetically modified organisms are at the heart of the Canadian economy. Generally speaking, GMOs are perceived more as foodstuffs capable of fostering trade rather than a threat to people’s health. WTO litigation or the absence of EU-Style labeling suggest that GMO enjoy great support from the government and the population. Although some municipalities declare themselves GMO-free, “moratoria” or “thresholds” are extraneous to the Canadian GMO-legislation. In addition, private law reveals itself quite incapable of compensating damages sustained by GMO activity. In synthesis, Canada aligns itself to liberal attitudes to GMO farming.

In 1988 the first application for field trials of a GMO was formally received in Mexico. Since then a Biosafety law, few bylaws and national official standards were enacted in order to regulate the safe use of GMOs and to evaluate, control and avoid adverse effects to human health and the environment. The Law on Biosafety of Genetically Modified Organisms was enacted in 2005 in order to comply with international obligations derived from the Cartagena Protocol on Biosafety signed by Mexico in 2000. This law established a biosafety legal framework to regulate the use of GMOs, protect biodiversity, and promote the conservation of organisms which Mexico is center of origin and center of genetic diversity. Since then, 561 permits for the release of GMOs into the environment have been granted between 2005 and 2014. This report gives and overview of the country’s approach to the use of GMOs, the current status of the biosafety legislation in Mexico and the development of policies and regulations since the first introduction of GM crops in the country.

During the course of the past year, numerous food scandals have served to raise the awareness of the potential dangers of GM food in Taiwan. The purpose of this article is to review the existing legal regime applicable to not only GM Food, but also the GM research in Taiwan, and to provide updated info on the latest development of GM food legal regime. It remains to be seen if the amended laws will be implemented effectively. It also remains to be observed whether anti-GM sentiment and legal developments will negatively impact Taiwan’s domestic GM industries.

Macau is a small territory located on the Western Side of the Pearl River Delta near the South China Sea. In terms of its present status, it is a special administrative region of the People’s Republic of China (PRC) established in line with the so-called “one country, two systems” principle laid down in the PRC Constitution. The scope of the Macau Special Administrative Region’s (Macau SAR) political and regulatory powers is regulated in the Macau Basic Law (MBL), which grants the Macau SAR a wide range of political and economic rights. These rights also establish the Macau SAR as a local and global actor, with, on the one hand, a wide field of regulatory autonomy in domestic affairs, and also in international affairs, for instance, as a member of various international organizations, such as the World Trade Organization (WTO) on the other. The present report presents a brief overview of the legal regime governing the issue of genetic technology and food security in the Special Administrative Region of Macau.