EU GMO Safety Legislation and Its Impact on Marketing

Introduction

In recent years, it has become increasingly apparent to citizens, policymakers, and government officials that safety legislation enacted in the European Union (EU) has significantly affected the manner and method in which companies market their products.

One of the most dramatically affected product categories involves genetically modified organisms (GMOs). A genetically modified organism is a man-made organism created in a laboratory through the process of genetic engineering. Since many unanswered questions remain regarding the safety and ethical issues surrounding GMOs, the European Parliament has adopted the world's most stringent rules on the labeling of GMOs, despite intensified pressure from the United States (Greenpeace, 2003). The legislation currently in place in the EU requires that all food and animal feed containing GMOs be clearly labeled. This labeling requirement has significant implications for the method and manner in which companies market their products in the EU. This paper discusses how EU safety legislation and specific cases regarding GMOs have affected marketing within the Union.

Arguments For and Against GMOs

Arguments exist both in favor of and against biotechnology and the use and production of GMOs. Supporters of GMOs and biotechnology assert several benefits arising from their use, serving both environmental and economic purposes. Proponents base their arguments on the efficiency and productivity inherent in transferring favorable characteristics into new plants (Horsch, 1999). Through higher food production per acre of farmland, proponents believe GMOs will enable farmers to feed a growing population while reducing the space that farmland occupies on scarce land (Horsch, 1999). In addition to environmental and economic benefits, GMOs are believed to offer varying health benefits through enriched food profiles and improved pharmaceutical development. Certain GMOs contain vaccines for diseases, enhanced vitamins and minerals, and reduced fatty acid levels (York, 2001).

On the other hand, opponents cite several threats associated with GMOs that merit further scientific investigation. One concern is the potential transfer of genes through natural hybridization from pesticide-resistant crops to wild or semi-domesticated relatives, potentially spurring the creation of uncontrollable "superweeds" (Alteri, 1999). Opponents also challenge the claimed benefit of pesticide reduction, citing the potential for insect pests to develop immunities to crops engineered to produce toxins (Alteri, 1999). Evidence supporting this concern comes from laboratory and field tests in which insects targeted by the toxins of Bt corn developed resistance (Alteri, 1999). Further concerns exist over threats posed to beneficial insects, as well as potential harm from human consumption — specifically allergenic reactions and long-term toxic effects (Ferber, 1999). Some opponents argue that genetic modification is inherently unnatural and unacceptable, while others raise concerns over the inclusion of animal genes in GMOs, creating disparities in moral and religious beliefs (Vogt & Parish, 1999).

The EU public has been strongly opposed to genetically engineered food since the first shipment of genetically enhanced soya arrived in Europe in 1996 (Greenpeace, 2003). Research consistently indicates that European consumers reject genetically enhanced food. The EU maintains a comprehensive regulatory framework designed to protect human health and sustain a single European market for biotechnological products (Greenpeace, 2003). Through an evolving approach reflecting the diversity of political views and historical attitudes toward food alteration technology, the EU provides a dual approach to biotech regulation — most notably, pre-marketing safety assessments. Previously, under the EU labeling rules, thousands of products such as oil, starch, and animal feed did not require labeling. Under current legislation, such products must be labeled, although EU consumers remain unaware of whether meat or dairy products come from animals fed with GMOs (Greenpeace, 2003).

Greenpeace's EU Advisor on genetic engineering has noted widespread public concern regarding genetic contamination and the marketing and labeling of foods. According to Greenpeace, if conventional and organic crops are not protected from genetic contamination, the new labeling system risks becoming useless within a few years, as it will become increasingly difficult to secure GMO-free supplies (Greenpeace, 2003). Consumer antipathy toward GMOs remains deeply entrenched in the EU; a recent Greenpeace survey of food companies showed that 170 out of 216 companies surveyed requested produce without any genetically enhanced ingredients (Greenpeace, 2003). Only 18 companies did not seek to exclude genetically enhanced food, underscoring the elevated standard companies face when marketing such products. Vigorous and effective public awareness campaigns have also been conducted by non-governmental organizations across Europe (Brough, 2000).

Legislative History of EU GMO Regulation

The legislative background surrounding GMOs has stirred considerable controversy between the EU and other countries, particularly the United States, which strongly advocates biotechnology and the use of GMOs. As stated by Justice Holmes in his historic dissent in Northern Securities Co. v. U.S., "these immediate interests exercise a kind of hydraulic pressure which makes what previously was clear seem doubtful, and before which even well-settled principles of law will bend" (193 U.S. 197, 1904). Historically, EU policymakers have faced the challenge of developing and applying GMO legislation in the context of continuing scientific uncertainty over potential adverse effects of GMOs on the environment and human health. This challenge has been accompanied by the simultaneous need to address international trade obligations, concerns over the competitiveness of the European biotechnology industry, and growing public concern over potential risks posed by genetically enhanced crops and foods.

In the 1990s, EU Industry Ministers called for changes to European rules regulating the use and release of genetically modified organisms. For the biotechnology industry in Europe, product approval processes were a primary source of concern. As a result, product legislation in the EU expanded, encompassing issues such as the regulation of the contained use of GMOs, the authorization of deliberate releases of GMOs into the environment through field testing and commercial growing, the authorization for market inclusion of GMOs and GMO products, and the labeling of GMOs and GMO products (Mackenzie & Franceson, 2000).

The regulation of GMOs in the EU differs markedly from that in the United States. Under the authority of the Federal Food, Drug, and Cosmetic Act (FFDCA), the FDA bears responsibility for ensuring the safety of most foods, including GMOs and genetically modified foods (21 U.S.C. 301–395 (1994)). The FDA regulates GMOs in the same manner as traditional food products derived from conventional breeding techniques. Although new food additives must be demonstrated safe before marketing, companies producing foods through biotechnological means do not need to obtain FDA approval before introducing such foods to the U.S. market, as U.S. and FDA policy recognizes that such foods are comparable to conventional foods and are generally regarded as safe. While companies have the option to consult with the FDA prior to marketing, such pre-marketing consultations are commonly requested voluntarily. Should a product raise health concerns during these consultations, the FFDCA empowers the FDA to require a pre-market review. In essence, the U.S. system places the burden on the producer to assure food safety (Francer, 2001).

As a result of the differences between EU and U.S. legislation, it is likely that numerous international legal disputes will arise. Litigation currently exists between the EU and the U.S. being arbitrated by the World Trade Organization. Before the WTO, the European Commission has argued in the context of food safety measures that the precautionary principle is "a general customary rule of international law, or at least a general principle of law, the essence of which is that it applies not only in the management of risk, but also in the assessment thereof" (Report of the Appellate Body, 1998). The U.S. position is that agricultural products enhanced through biotechnology do not differ significantly from their traditional counterparts, and therefore no general requirement exists for the labeling of agricultural products derived from or containing GMOs. In the U.S., while some circumstances may call for labeling — such as when a genetically modified food differs considerably from its conventional counterpart — such labeling would likely be required only to warn consumers of potential threats.

However, mandatory labeling of genetically modified foods may constitute an unconstitutional violation of free speech in the U.S., as demonstrated in a 1994 Vermont case challenging a law requiring the labeling of milk and milk products derived from cattle treated with recombinant bovine somatotropin. In International Dairy Foods Ass'n v. Amestoy, the court held that the labeling statute would probably be found unconstitutional given Vermont's failure to demonstrate cognizable harm and given that the First Amendment protects companies' right not to speak (898 F.Supp. 246 (D. Vt. 1995)). This approach is not reflected in any litigated EU court cases.

Conclusion

MacKenzie, R. & Franceson, S. 2000. 'The Regulation of Genetically Modified Foods in the European Union: An Overview,' 8 N.Y.U. Envtl L.J. 530, pp. 534.

Murphy, S. 2002. 'Structural Distortions in World Agriculture Markets: Do WTO Rules Support Sustainable Agriculture?' 27 Colum. J. Envtl. L. 605.

Report of the Appellate Body 1998. 'EC Measures Concerning Meat and Meat Products (Hormones),' AB-1997-4, WT/DS26/AB/R, para. 16.

Vogt, D. & Parish, M. 1999. CRS Report to Congress: Food Biotechnology in the United States: Science, Regulation, and Issues. Available at: http://usinfo.state.gov/typical/global/biotech/crsfood.htm.

York, G. 2001. 'Global Foods, Local Tastes and Biotechnology: The New Legal Architecture of International Agriculture Trade,' 7 Colum. J. Eur. L. 423.

International Dairy Foods Ass'n v. Amestoy, 898 F.Supp. 246 (D. Vt. 1995).

Northern Securities Co. v. U.S., 193 U.S. 197, 400–01 (1904) (Holmes, J., dissenting).

Council Regulation No. 1139/1998

Commission Directive 97/35/EC

Council Regulation 258/97: Novel Foods Regulation

Council Directive 90/220/EEC: Deliberate Release Directive