Whereas the debate over GMOs in Europe has been characterized by public protests and a high level of consumer activism, the American public has been relatively slow to react to this new technology.  Unlike the British, for instance, whose concerns about food safety have been on the rise since the outbreak of mad cow disease in 1996, Americans have seemed largely indifferent to genetically modified foods.   

An important reason for this apparent lack of concern is that only a very few Americans have been aware of the introduction of GMOs into the food chain.  Since the U.S. government has classified GMOs as mere additives in food, the Food and Drug Administration (FDA) is not required to approve them prior to sale and marketing to consumers.  Nor is there a labelling requirement for genetically engineered products. In accordance with FDA regulations, the only foods subject to mandatory labelling are those with ingredients that are proven to either change the nutritional content of a food or cause allergic reactions. 

Nonetheless, public opinion in the U.S. is rapidly shifting in favor of stricter regulations and mandatory labelling for GM products.  According to a recent poll by Time magazine, 81% of Americans want GM food to be labelled. 

NGOs’ Attempts to Contain GMOs 

NGO efforts are largely responsible for the American public’s newfound concern over GMOs. In late fall 1999, Greenpeace invaded cereal maker Kellogg’s headquarters in Battle Creek, Michigan, to protest the company’s use of genetically engineered grains.  One of the activists even dressed up as Kellogg’s trademark Tony the Tiger, or "Franken Tony,” as he is better known among GM opponents.  Many U.S. environmentalist and consumer activist groups have since launched their own campaigns against GMOs, although Greenpeace remains one of the most vocal organizations in the U.S.  Through its True Food Network, Greenpeace has been instrumental in pressuring companies such as Heinz and Gerber to drop genetically altered soybeans and corn from their baby formulas. In Europe, Kellogg’s has already begun to phase out their GM products in response to Greenpeace’s demands.[1] 

American NGOs have also turned to the law in their efforts to protect the environment from the advances of biotechnology.  In late February 1999, 65 plaintiffs, including Greenpeace, the Sierra Club, and the International Federation of Organic Agricultural Movements, filed a lawsuit in the district court of Washington D.C. against the U.S. Environmental Protection Agency (EPA) on grounds that it had acted unlawfully in its approvals of crops engineered to produce Bt toxin, a gene-modified insecticide produced by the soil bacterium Bacillus thuringiensis.[2] The suit demands that the EPA immediately withdraw its approval of all Bt plants and refrain from making any new approvals until a complete, scientific environmental impact assessment has been carried.   

While the EPA has rejected all accusations that it may have approved any biotechnology products without due consideration of their potentially harmful environmental effects, some scientist groups, such as the Union of Concerned Scientists, have confirmed that the EPA’s current approval process for biotech crops is inadequate.[3]  In response, EPA’s Scientific Advisory Panel announced in February 2000 that it would advise the EPA to test crops on a wider variety of insects than the four species currently tested. It also recommended that the EPA require more data from seed companies on the impact of GM crops in the field.[4] 

American Legislators’ Attempts to Contain GMOs 

The concern over the safety of genetically engineered products has also begun to infiltrate U.S. politics. In October 1999, Representatives David Bonior, Dennis Kucinich, and Chris Shayes and 46 other House members sent a letter to FDA Commissioner Jane Henney calling for mandatory labelling of genetically engineered foods. A month later, Representative Kucinich introduced Bill H.R. 3377, the "Genetically Engineered Food Right to Know Act, ” which states that all foods that contain or are produced with genetically engineered material must be labelled as follows:

GENETICALLY ENGINEERED

United States Government Notice: This product contains genetically engineered material, or was produced with a genetically engineered material. 

The bill has garnered the support of fifty co-sponsors and is currently awaiting review in the House Subcommittee on Health and the Environment. In late February this year, Barbara Boxer introduced a similar bill (S. 2080) in the Senate. 

On March 9, 2000, Representative Kucinich upped the ante further when he introduced bill HR 3883, "The Genetically Engineered Food Safety Act.” This bill would require all GM foods to be examined for allergenicity, unintended effects, toxicity, functional characteristics, and nutrient levels—in addition to passing FDA’s regulations for food additives. The bill would also require the FDA to 1) allow a public comment period of at least thirty days once a completed safety application is available to the public, and 2) disclose all studies performed by the applicant to the public.  Bill HR 3883 has the support of nine co-sponsors.  

Passing these bills, however, will not be easy. On January 26, 2000, Senator Christopher Bond (R-Missouri) testified before the U.S. Senate on the benefits and politics of biotechnology, accusing "some elements of the European Union” of seeking to provide "short-term protection to their farmers….[and] limit the productivity of foreign farmers” by exploiting public fears of genetically engineered foods.[5] Senator Bond, with the support of 23 other Senators,[6] urged the Administration to be firm in its negotiations on biotechnology products, and to not yield from its insistence on science-based, rather than politically influenced, risk assessments.  Senator Bond also criticized food companies that have chosen to forego using GM inputs in their products for "knowingly undermining our scientists and trade negotiators to placate the Luddites and protectionists.” 

U.S. Industry’s Views 

In a letter to President Clinton dated November 12, 1999, thirty-eight organizations representing a cross-section of the U.S. agri-food industry urged the Administration to not adopt new labelling policies for foods that contain genetically engineered additives.[7]  Specifically, these organizations expressed their concerns that if the FDA were to require labelling for biotech products, such labelling could have the effect of misleading consumers into believing that biotech foods are either "different" from conventional foods or represent a potential health risk.  By changing the current policy to require special labelling, the FDA also would run the risk of undermining its own credibility. 

Nonetheless, on August 31 1999, Archer Daniels Midland Company (ADM) issued its recommendation that farmers selling to the company segregate non-genetically enhanced crops to preserve their identity.[8] Although ADM later modified its stance and issued a statement explaining that it would not turn away genetically modified grains, other American (and Canadian) companies have stuck with their decisions to eliminate GMOs from their products: 

• Seagram no longer accepts GMO corn (beginning in the fall 2000).[9] 

• McCain Foods Ltd. no longer accepts genetically modified potatoes.

• Frito-Lay, a division of Pepsico Inc., has confirmed that it will not buy GM corn for use in its chips. 

• Whole Foods Market Inc., which has 103 stores nationwide, has announced that it is banning genetically engineered foods from its store brands.  

EU Regulation of GM Products 

The main EU legislation concerning the release of GMOs into the environment is Council Directive 90/220/EEC, which was adopted on April 23, 1990, and amended by Commission Directive 94/15/EC of April 15, 1994, and Commission Directive 97/35/EC of June 18, 1997.  Under this legislation, EU countries are required to regulate the release of GMOs into the environment so as to "minimize their potential negative effects on human health and the environment, since living organisms released in the environment for experimental purposes or as commercial products may cross national frontiers and affect other Member States by virtue of their irreversible effects on the environment.”[10]  Any person seeking to release GMOs into the environment (plant seeds, for example) must submit a notification of intent to the competent authority of the country in which the release will take place.  The notification must be accompanied by a full dossier of information including a full risk assessment, appropriate safety and emergency response measures, and in the case of products, precise instructions and conditions for use, plus a proposal for labelling and packaging.[11] 

The EU has also adopted Regulation (EC) No. 258/97 (Novel Foods Regulation) and Regulation (EC) No. 1139/98 (labelling of foodstuffs containing or derived from Monsanto’s RR soy and Novartis’ Bt-Corn) to ensure the mandatory labelling of any food products that contain protein or DNA resulting from genetic modification.[12]  

Critics of these regulations have complained that the EU’s legal framework concerning labeling is not fully transparent. Specifically, producers of genetically engineered goods have called for harmonization of the EU’s and the individual EU countries’ regulations on GMOs.[13] 

In response, the EU Commission presented a proposal in October 1999 (IP/99/783) for completing the current labelling rules and providing greater legal certainty for both producers and consumers. The proposal included two main provisions: 1) a de minimis labelling threshold of 1% to allow for the accidental inclusion of GM content in a product’s ingredients, and 2) new rules for making foods containing GMO-derived additives and flavorings subject to the same labelling rules as those of the Novel Foods Regulation.[14]   

The de minimus threshold is intended to solve the problem faced by producers who have tried to avoid GMOs but who, due to "accidental contamination,” still find themselves with a low amount of GM material in their products.  However, the proposed threshold only applies to goods already authorized for human consumption in the EU.  The threshold allowance is also subject to the following conditions:

• The origin of the GM material must be accidental (i.e., producers must submit evidence that they have avoided GM source materials).

• The proportion of GM material accidentally present must not be higher than 1% of each individual ingredient.  For example, in the case of a processed product containing maize starch, the percentage of allowed GM material is not 1% of the product itself, but rather 1% of the starch.

 The Novel Foods Regulation requires labels to identify foods that:

• have additives or flavorings that are, contain, or consist of GMOs;

• raise a particular safety (e.g. allergies) or ethical concern; and

• are not equivalent to their conventionally produced counterparts (i.e. contain protein or DNA resulting from genetic modification).

On June 25, 1999, at the EU Council of Ministers meeting in Luxembourg, the European environment ministers agreed to a set of new regulations for GMOs and to put a hold on the authorization of new GMOs until a new directive comes into force in 2002 and a new framework of rules on labelling and monitoring has been established.  Although the vote was not unanimous (Spain, Portugal, and the U.K. declined to sign the agreement due to fears that its wording might be legally challenged by the biotechnology industry), all fifteen EU member countries will have to abide by the new regulations.  

The agreement’s provisions include more stringent risk assessments of all GMO releases, a post-market monitoring regime for all releases, a more comprehensive labelling scheme, and the phasing out of antibiotic marker genes.[15]  The Council also decided to replace open-ended authorizations for GM products with authorizations limited to a maximum of 10 years.  Although a blanket moratorium on new approvals would have been illegal under EU law, the effect of these new regulations is the same: A complete ban on the introduction (and importation) of new genetically altered goods until 2002.

The Potential for a WTO Challenge of the EU’s New Regulations 

The U.S. is deeply concerned about the long-term effects of the EU’s de facto moratorium and has threatened to bring its complaints before the WTO dispute settlement body. So far, however, all efforts to build a solid legal basis for a formal challenge against the EU have come up short because the EU has not explicitly rejected more GMO approvals, but merely postponed further action until a new directive is in place. [16]  

Absent the EU’s clear rejection of GMOs, the U.S.’s next best legal argument would likely be to charge the EU with "undue delay" as set out in Annex C of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). However, this provision is not legally defined in the Agreement, and the EU could dispute the applicability of the entire Agreement in relation to GMOs because biotechnology products do not fit under any of the Agreement’s four categories of risk factors: additives, toxins, contaminants, and disease-causing organisms.[17]  The challenge for the U.S. would then become one of changing or negotiating an understanding on the SPS Agreement so as to accommodate GMOs. So far, the U.S. Administration, lobbied heavily by domestic agricultural groups, has opposed re-opening the SPS Agreement, and has been hesitant to endorse clarification of its provisions out of fear that any tinkering with the agreement could lead to a weakening of existing provisions.[18] 

There are two other WTO agreements that may provide support for the U.S. position: the Agreement on Technical Barriers to Trade (TBT Agreement), and the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement). According to the least trade restrictive rule of the TBT Agreement, governments are required to minimize the negative impacts on trade when setting domestic product regulations a rule that could possibly be used to challenge the EU’s labelling requirements for GM and GM-containing products. Similarly, if genetically engineered agricultural products are patented, the TRIPS Agreement might diminish the ability of the EU governments to restrict the release and sale of those products.  

The Precautionary Principle  

Although the WTO SPS Agreement recognizes the relevance of the precautionary principle to trade measures, it gives no specific definition for this safety first approach to regulation: 

"In cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available scientific information, including that from the relevant international organizations as well as from sanitary and phytosanitary measures applied by other Members.  In such circumstances, Members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time.”[19] 

Nonetheless, the EU has used the precautionary principle to justify its import bans on potentially hazardous goods—despite the United States’ insistence on the use of "sound scientific data” for determining risk. The EU rationale comes, in part, from the EC Treaty, which incorporates the following provisions already introduced by the Maastricht Treaty of 1992:  

"Community policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Community.  It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay. . . ."[20] 

In order to provide some structural guidelines on the appropriate use of the precautionary principle, the EU Commission on February 2, 2000 issued a communication with the fourfold aim of: 

• outlining the Commission’s approach to using the precautionary principle,

• establishing Commission guidelines for applying it,

• building a common understanding of how to assess, appraise, manage and communicate risks that science is not yet able to evaluate fully, and

• avoiding unwarranted recourse to the precautionary principle as a disguised form of protectionism.

While the communication was directed to the Community, it also seeks to provide input to the ongoing international debate over the proper application of the principle.  

The U.S., along with the rest of the Miami group, however, has pushed for WTO legal supremacy over the Biosafety Protocol, which explicitly adopted the precautionary principle.[21] The so-called Like-Minded Group, which consists of over one hundred developing nations, along with the EU, has taken the position that the Biosafety Protocol should be co-equal to the WTO.

"Substantial Equivalence"

At the OECD Conference on the Scientific and Health Aspects of Genetically Modified Food, which was held in Edinburgh in late February 2000, another important scientific concept" "substantial equivalence" "was discussed in legal terms.  Introduced by the OECD in 1993, the concept of substantial equivalence means that if a GM food can be characterized as being chemically similar to its natural counterpart, it can be assumed to pose no new health risks.  The concept was endorsed by the United Nations Food and Agriculture Organization (FAO) and the World Health Organization (WHO) three years later, and it has been employed ever since.[22]  As a result of the OECD Conference, however, this approval system is likely to be re-evaluated in upcoming international meetings on GMO safety standards, such as the Codex Alimentarius meeting in Tokyo in March 2000.  The Codex task force on GM food standards aims to develop global legal standards on how to evaluate the safety of GM foods by 2003.

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