Genetically Modified Foods: The United States v. the European Union
Ann Berridge
Professor David Friedman
Legal Issues of the 21st Century
Final Paper
May 10, 2004
Imagine a world where people are suffering from starvation, it’s not very difficult. The starving people are offered food from another wealthier country. This food is healthy, consumed by many people from the country where the food is grown, but has not been tested and researched to be considered safe for human consumption. Due to the unknown facts about the safety of the food the starving people refuse the offer and choose to continue to starve. The situation described above illustrates what happened in Southern Africa in 2002. Southern Africa was devastated by famine and the United States offered aid in the form of genetically modified[1] grains. Several countries requested that the grain be milled so that it could not cross-pollinate with the grains grown locally while Zambians declared that the grain was “poison” and refused to accept the aid. Although the safety of genetically modified foods is one reason the Zambians refused to accept aid, there is an even more formidable reason. Half of South Africa’s agricultural exports are sold on the European markets. By accepting genetically modified grains they may possibly be contaminating their crops which would destroy their trade relations with Europe.[2] Additionally, the Southern African countries fear that the acceptance of the United States aid would leave them dependent on the biotechnology companies that developed the grain.[3]
As illustrated by the passage above, the United States and the European Union are engaged in a global “food fight.” The two trade powers are at odds due to their very different stances regarding genetically modified foods. The United States maintains a liberal position while the European Union maintains a conservative position. The United States is very product focused. Their concern is with advancing the science of genetic modification. In order to promote the swift advancement in technology the United States has taken the following three prong view. Their policy on genetically modified food 1) is product based, 2) presumes that the risk of genetically modification is low, or equal to that of the natural foods currently consumed, and 3) proposes that the existing federal standards are sufficient to be applied to genetically modified foods.[4] The United States’ policy on genetically modified foods has been based on these principles since 1992 and has changed minimally since then. The policy of the European Union is focused on the process of creating genetically modified foods rather than the end product. The European Union maintains its conservative position based on the lack of scientific knowledge of the long term effects of genetically modified organisms. In order to ensure the safety of society legislation has been enacted to strictly scrutinize genetically modified products and to provide notice to the public that what they are purchasing is a product of genetic modification. The European Union has actively been proposing legislation as new issues and concerns arise. The European Union places a great deal of emphasis on the rights of its citizens to be informed and their concerns about the safety of releasing genetically modified products onto the European market place.
The purpose of this article is to trace the history of the policies of the United States and the European Union with regards to genetically modified products in order to see how they have arrived at their current position. By looking at the political histories, similar goals can be seen and used to establish a basis for cooperation. In analyzing the similarities and differences of the two trade powers a solution to the impasse should become apparent. If the wants and needs of both of these trade powers can be satisfied, a compromise can be reached that will not only benefit these two political entities, but also the rest of the world by providing a uniform system to regulate genetically modified products from the process of making them to their final product.
The History of the Policies of the United States with Regards to the Regulation of Genetically Modified Products
In the early 1980s, the introduction of genetically modified foods onto the United States market was inevitable. Congress began to conduct hearings about the new wave of genetically modified products and to draft legislation to specifically deal with this new technology[5]. The Reagan and Bush Administrations worked at outlining a federal regulatory policy that would maintain the United States position as a leader in the field of GM techniques while providing for the public’s safety[6]. These administrations felt that the regulation of GM techniques should avoid being burdensome and unnecessary. With these goals in mind the Reagan and Bush Administrations developed three major principles of United States policy: 1) the focus is on the end product rather than process used to arrive at the GM product, 2) regulation should be grounded in verifiable scientific risks, and 3) GM products are sufficiently similar to current products and therefore, the existing statutes are sufficient to regulate them[7]. Also, to address Congressional interest in the matter, the Reagan Administration created an inter-agency working group within the White House Office of Science and Technology Policy (OSTP). This group was charged with drafting an overall federal framework for the regulation of food biotechnology.
In 1986 the OSTP finalized version of the Coordinated Framework for Regulation of Biotechnology. This document contains an outline of the existing jurisdictions of regulatory agencies that would oversee GM products. The three regulatory agencies listed were the Food and Drug Administration (“FDA”), the U.S. Department of Agriculture (“USDA”), and the Environmental Protection Agency (“EPA”.) The FDA is responsible for regulating food and feeds. The USDA’s Animal and Plant Health Inspection Service (APHIS) regulates the importation, interstate movement, and environmental release of transgenic plants. The purpose of their regulation is to protect the United States’ existing crops[8]. Additionally, the USDA is responsible for issuing licenses for field testing of food crops prior to their commercial release. The EPA requires companies producing genetically modified products to register certain pesticide products in transgenic plants prior to their distribution and sale. It is also their responsibility to establish pesticide tolerances for residues in foods.
After the release of the final version of the Coordinated Framework for Regulation of Biotechnology the White House and the above federal agencies worked together to determine how each agency would exercise its responsibilities. The Bush Administration’s OSTP released “Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of Biotechnology Products in the Environment” in 1992[9]. This policy was framed to provide direction on implementing policy as outlined in the Coordinated Framework for Regulation of Biotechnology[10]. In this draft it stated that federal regulation should be limited to science-based risk assessments[11]. Additionally another policy document released, Principles for Federal Oversight of Biotechnology: Planned Introduction Into the Environment of Organisms with Modified Hereditary Traits, stressed the importance of focusing regulation on the end product rather than the process by which the product was created[12]. It emphasized that regulation should be based on the characteristics and the risks of the product. The second principle stated that while regulation should ensure the safety of the consumer the review required should place a minimal burden on the release of the GM product. The third principle took the second principle even further by suggesting that regulation should accommodate “rapid advances in biotechnology[13].”
In 1992 a final Statement of Scope was issued by the Bush Administrations OSTP. The policy stated “oversight will be exercised only where the risk posed by the introduction [of GM products] is unreasonable... when the value of the reduction in risk obtained by additional oversight is greater than the cost thereby imposed.” Additionally, in this document five policy principles were listed giving the clearest guidelines of the government’s stance on GM foods. The five policy principles are:
  1. The same physical and biological laws govern the response of organisms modified by modern molecular and cellular methods and those produced by classical methods;
  2. Information about the process used to produce a GM organism is... not a useful criterion for determining whether the product requires less or more oversight;
  3. No conceptual distinction exists between genetic modification of plants and microorganisms by classical methods or by molecular techniques...;
  4. Crops modified by molecular and cellular methods should pose risks no different from those modified by classical methods for similar traits...; and
  5. In many respects, molecular methods resemble the classical methods for modifying particular strains of microorganism, but [are more cost-efficient and accurate than the classical methods[14].]
Although this final statement of scope outlines the clearest guidelines of the government’s position on GM products, there is no mention of what a “measurable risk” is or how much scientific evidence is needed to prove that a GM product is a risk to the public’s safety and should be regulated more strictly.
Once the guidelines for scope were set forth the regulatory agencies were responsible for taking action to implement the policy. The FDA, USDA, and the EPA have since focused their policies on the three-part approach developed by the White house and the OSTP.

I. The FDA’s Regulatory Policies Regarding GM Products
The FDA’s regulatory policies focus on the principle that absent any identifiable risk or scientific basis for concern a product may be placed on the market. Since these products are regulated under the same standards as all natural foods they fall under the jurisdiction of the Federal Food, Drug, and Cosmetic Act (“FFDCA”). Under this act it is the manufacturer’s responsibility to ensure that the product they are placing on the market is not adulterated or misbranded. Food is considered adulterated if it “bears or contains any poisonous or deleterious substance which may render it injurious to health[15].” Additionally, foods that contain novel ingredients are subject to a higher degree of review. Any ingredient that is added to food must be approved as food additives or must be considered generally recognized as safe. Under 21 U.S.C. §321(s) food additive is defined as a substance, the use of which may “reasonably be expected to result directly or indirectly, in its becoming a component” or “otherwise affecting the characteristics” of the food to which it is added. In order for a manufacturer to get approval for a food additive they must submit a petition as set out in 21 C.F.R. part 171. This petition includes substantial scientific evidence that the food evidence is safe and that there is “reasonable certainty” that no harm will result from using the additive. The scientific evidence is made up of extensive toxicity and feeding studies. In order for approval a manufacturer must meet all of the above requirements[16].
However, if a food is considered generally recognized as safe there is no need for a manufacturer to apply for approval as a food additive or to submit to additional screening[17]. For a food to be considered generally recognized as safe a great deal must be known about its safety. If there is not enough knowledge, then the food is subject to review as a food additive.
Because the food additive approval process is lengthy and not much is known about the safety of genetically modified foods it could be assumed that in order to get approval for marketing a GM product the process would be timely and costly. Due to inquiries regarding this issue the FDA released “Statement of Policy: Foods Derived from New Plant Varieties” to “clarify its interpretation of the [FFDCA] with respect to human foods and animal feeds derived from new plant varieties, including but not limited to plants developed by new methods of genetic modification.”[18] The stated purpose of this document was not only clarification; the purpose was twofold. First it stated that the FDA’s view was that most GM products were considered generally recognized as safe or were likely to be generally recognized as safe. This position meant that most GM products are not subject to review as food additives. The second purpose of the document was to outline a voluntary pre-market consultation process meant to safeguard against erroneous GRAS presumptions.
In 1997 the FDA released another document, “Guidance on Consultation Procedures for Foods Derived from New Plant Varieties,” defining the types of information the agency scientist would like to see presented at the voluntary pre-market consultations. In addition to reviewing information presented by the manufacturer the meeting would consist of discussing any other outstanding issues concerning the product.
In 1999 the FDA began to hold public hearings to address the growing public concern over the labeling of genetically modified products. Three major themes surfaced from the comments made at these hearings: 1) there was no evidence that would indicate that GM foods currently on the market are unsafe[19], 2) whether the FDA’s current regulatory regime was adequate to ensure safety[20], and 3) whether labeling GM products should be required[21]. January 2001 the FDA issued a response to these issues by proposing a new rule that requires manufacturers of “plant-derived, bioengineered foods, and animal feeds” (GM products) to notify the FDA at least 120 days before GM products are marketed via a “Pre-market Biotechnology notice[22].” This proposed rule made the voluntary pre-market consultations mandatory for manufacturers to receive approval to introduce their GM products onto the market.
In response to the second theme of whether the FDA’s current regulatory regime was adequate to ensure safety the FDA published a notice on August 2, 2002, “Proposed Federal Actions to Update Field Test Requirements for Biotechnology Derived Plants and to Establish Early Food Safety Assessments for New Proteins Produced by Such Plants[23].” This document acknowledges that with the increased number of GM agricultural products being approved there is a higher likelihood that conventional products will be contaminated. It states that the three regulatory agencies will continue to issue updated regulations and guidance with regards to the issue of contamination as they deem relevant. Additionally, the FDA’s review of GM products will extend to crops that are not food because they can enter the food supply via contamination and cross-pollination[24].
The FDA published “Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering[25]” as a response to the labeling issue brought up in the comments from the hearing. This document reaffirmed that the FDA would not require special labeling of all bioengineered foods. The reasons stated were that labeling is unnecessary because GM products are equivalent to their conventional counterparts, labeling would cause confusion and potentially be false and misleading. However, the FDA did state that labeling would be mandatory if the GM product differed from its conventional counterpart significantly[26]. They also offered a list of voluntary labeling phrases that could be used by manufacturers[27].
Currently, it is the FDA’s controls include 1) communicating clearly - through the agency’s 1992 policy statement and subsequent guidance - what safety data are necessary for its evaluations of GM food safety; 2) having teams of FDA experts in diverse disciplines evaluate company submissions for GM foods and request additional safety data, if necessary; and 3) tailoring the level of evaluation to mach the degree of each submission’s novelty, thereby assuring that staff have time to obtain safety data[28]. Although this is the FDA’s current control policy it recognizes that there is room for improvement by making the process more transparent and randomly verifying test data that they receive from manufacturers[29].
II. The USDA’s Regulatory Policies Regarding GM Products
The USDA initially took a more cautious approach than the other two regulatory agencies even though they agreed that the existing statutory framework and analysis based on scientific risk were the appropriate policies. The USDA initially required that any GM product that was deemed to have the potential to spread or cause injury to other plants was subject to a pre-introduction permit. In addition to the pre-introduction permit process the USDA agreed that regulation of GM products would fall under the Federal Plant Pest Act (“FPPA”) which empowers the USDA to regulate imports and the movement of items deemed to be “plant pests”[30]. The FFPA allows the USDA to confiscate, quarantine, destroy and/or apply other necessary measures to deal with articles infested or infected with plant pests[31]. In 1992 the USDA relaxed its review by providing a notification process by which certain organisms would not be required to enter the pre-introduction permitting process if the plant satisfies six criteria[32]. Again in 1997 the USDA amended its policies opening the notification process to all plants and not just the ones that matched the six criteria under the 1992 policy, as long as they possessed the same low-risk characteristics[33].
III. The EPA’s Regulatory Policies Regarding GM Products
The EPA regulates whether or not products are safe for the environment and human use. When asked to regulate GM products in this context the EPA decided that its current policies under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) would provide adequate regulation for GM plants with pesticidal properties[34]. No other regulations were implemented. In 1994 the EPA issued a policy statement introducing the term “plant-pesticide” which refers to GM products under EPA authority. The definition of “plant-pesticide” is a “pesticidal substance that is produced in a living plant and the genetic material necessary for the product of the pesticidal substance, where the pesticidal substance is intended for use in the living plant[35].” Additionally the 1994 policy statement provided a list of products that were exempt because their risk was considered negligible[36]. If products qualified for this exemption they avoided extensive pre-market testing required by FIFRA. Also, the 1994 policy never formally addressed the degree of testing appropriate for plant-pesticides[37].
In 2001 the EPA finalized the 1994 policy publication. In this rule the term “plant-pesticide” was changed to “plant incorporated protectant.”[38] “Plant incorporated protectant means a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance[39].” This change in terminology excludes plants with chance pesticidal modifications, while the former definition included all plants with pesticidal modifications. The 2001 rule also finalized the exemptions in the 1994 policy proposal and stressed that the focus of the EPA’s regulation would be on the pesticidal properties of plants rather than the plants themselves.
The History of the Policies of the European Union with Regards to the Regulation of Genetically Modified Products
Regulation of GM organisms (“GMOs”) in Europe began in the early 1990s. The stated purpose for initiating regulation was to protect the safety of the “citizens’ health and the environment while simultaneously creating a unified market for biotechnology[40].” In implementing legislation concerning GMOs the European Committee issued directives and regulations to the member states of the European Union. The member states then rewrote their existing laws to conform to the regulatory procedures outlined in the directives and regulations.
The main legislation under which GMOs were regulated until October 17, 2002 was Directive 90/220/EEC. This directive authorized the experimental releases and placement of GMOs on the market. Directive 90/220/EEC was repealed by Directive 2001/18/EEC. Directive 2001/18/EEC updated the directive of the European Parliament and Council on the deliberate release of GMOs[41]. This directive provides a step by step approval process based on a case by case assessment of the risks posed to human health and the environment. All GMOs must submit to this process for approval before it may be released into the environment or be placed on the market.
Directive 2001/18/EEC also strengthens the basic principles set forth in the original legislation while introducing the following new concepts: principles for the environmental risk assessment; mandatory post-market monitoring requirements; mandatory information to the public; requirement for Member States to ensure labeling and traceability at all stages of the placing on the market; first approvals for the release of GMOs to be limited to a maximum of ten years; the consultation of the Scientific Committee(s) to be obligatory; an obligation to consult the European Parliament on decisions to authorize the release of GMOs; and the possibility for Council of Ministers to adopt or reject a Commission proposal for authorization of a GMO by qualified majority[42].
In order for a GMO to get approval under Directive 2001/18/EEC the manufacturer must first submit an application to the national authority of the Member State where it wished to put the product on the market. Next the product is subject to a full environmental risk assessment. When performing the environmental risk assessment three factors are considered: the characteristics of the inserted genetic material, the final product produced, and the environment into which the product will be released and the possible interactions that might occur between the product and the environment[43]. The methodology used is as follows: identify any characteristics of the GMO(s) which may cause adverse effects; evaluation of the potential consequences of each adverse effect; evaluation of the likelihood of the occurrence of each identified potential adverse effect; estimation of the risk posed by each identified characteristic of the GMO(s); application of management strategies for risks from the deliberate release or placing on the market of GMO(s); and determination of the overall risk of the GMO(s). The environmental assessment also reviews the process of creating the GMO, the risk associated with the gene products produced by the GMO, and gene transferability[44]. If the GMO receives a favorable opinion from the national authority that Member State inform the other Member States via the Commission. If no objections arise then consent to place the GMO on the market is granted and the product may be marketed throughout the European Union.
If a favorable opinion is not issued the decision is submitted to the Council of Ministers. The decision will be adopted or rejected by qualified majority. If the Council does not respond within three months the Commission can adopt the decision[45]. The public is kept informed during this process via the internet[46].
Directive 2001/18/EC provides thorough and transparent guidelines concerning the release of GMOs into the environment, but it does not cover products that are derived from GMOs[47]. Products derived from GMOs are regulated by other policies such as the Regulation on Novel Foods and Novel Food Ingredients of January 27, 1997[48]. This regulation outlines rules for authorization and labeling of novel foods. The definition of novel foods includes food products containing, consisting, or produced from GMOs[49]. The authorization procedure is the same as the approval process under Directive 200/18/EEC, except the Novel Food Regulation allows a simplified procedure for foods derived from GMOs, but no longer containing GMOs. In addition to being GMO-free the food must be substantially equivalent to existing foods[50]. Under the simplified procedure manufacturers are required to notify the Commission when placing a product on the market. In addition to notifying the Commission the manufacturer must provide scientific justification that the product is substantially equivalent or it is the opinion of the authorities of the Member State that the product is substantially equivalent[51].
The European Commission has also provided legislation with regards to labeling and containment in response to concerns expressed by its citizens. Both Council Regulation (EC) 1139/98 and Regulation (EC) 50/2000 address the issue of labeling and GMOs. Council Regulation (EC) 1139/98 supplies provisions for the labeling of foods and food ingredients derived from one maize and one Soya variety based on the presence of DNA or protein resulting from genetic modification[52]. Regulation EC 50/2000 requires that final products that contain additives and flavorings that contain DNA or proteins from GMO origins be labeled[53]. Regulation (EC) 49/2000 proposes a 1% de minimis threshold for the presence of DNA or protein resulting from genetic modification. Any product below this threshold does not require labeling[54].
On July 25, 2001 the European Commission released a proposal with the hopes of harmonizing the community system. The proposal addressed the issues of tracing GMOs, labeling GM fee, reinforcing the current labeling rules concerning GM food, and streamlining the authorization procedure for GMOs in food and feed and their deliberate release into the environment[55]. This proposal is meant to address continuing concerns on the behalf of the industry and consumers.
Issues that Need to be Addressed in Order to Avoid Trade Wars
The United States and the European Union need to address two main issues in order to begin working on a compromise. The first is the method of regulation with regards to the health and welfare of their citizen’s and the world population. The second is labeling of genetically modified products. With regards to the issue of regulation there are different sub-issues which must be addressed. The first is what approach the two political powers should take. Should they take the United States’ approach of being product focused or the European Union’s approach of focusing on the process or should there be a combination approach focusing on the entire process and the end product? The second is to explore a system of standards. What should be considered a measurable risk and what amount or type of scientific evidence is necessary to prove a measurable risk? It may seem naïve to assume that a blanket standard would cover all countries. However, this paper is only exploring the standards of the United States and the European Union where the most pertinent issue in determining a standard is economic. The analysis is less likely to be based on fundamental needs such as needing food for survival. The third issue is whether or not pre and post market validation should be implemented. Should pre-market scientific evidence of safety be validated? Should there be post market testing to ensure that the product is still safe after being introduced onto the market? The fourth category is what should be regulated. Currently, regulation encompasses GM foods, GM products, products derived from GMOs, and GM feed. The final issue is the transparency of regulation. In comparison to the European Union the regulation policies of the United States lack a great deal of transparency.
There are also several sub-issues that must be addressed with regards to labeling. The first conflict that must be addressed is whether or not labeling is necessary. Currently, the United States has a system of voluntary labeling and the European Union has enacted Regulations addressing the requirements of labeling. If labeling is necessary then what products should be labeled, i.e. foods, products derived from GMOs. Additionally, besides determining what products should be labeled, what should the label disclose and how should it be written? Under the current system the United States does not require labeling and the European Union does. Due to the United States’ refusal to label GM entities, trade with the European Union will soon cease unless an agreement on labeling can be reached.
As stated above the United States and the European Union must decide whether they wish to continue to operate separately under their own systems or reach a compromise on the issues of regulation and labeling. If each of these powers were only dealing within their own borders continuing to implement their current system would not cause any problems. Unfortunately, or fortunately, depending on one’s view, these two powers are integral parts of the global economy. The United States is a very strong exporter and the European Union relies heavily on imports. Both are operating on the global market and their current systems are causing friction. One would think that remaining on separate systems is feasible because other industries, such as pharmaceuticals, allow for separate systems in a global market. This is not the case. Currently, the United States is in conflict with Canada because of their differences in pharmaceutical systems. Although separate systems function for a while the increasing expansion of the markets into a global realm are forcing a need for a singular or compatible systems. A compromise would avoid perpetuating a trade war concerning genetically modified products.
So far, no real efforts have been made to reach a compromise. One example of the United States flexing its muscles and trying to force the European Union into action is apparent in a press release by the Office of the United States Trade Representative entitled “U.S. and Cooperating Countries File WTO [World Trade Organization] Case Against Moratorium on Biotech Foods and Crops: European Union’s Illegal, Non-Science based Moratorium Harmful to Agriculture and the Developing World[56].” The press release stated that the United States had filed this WTO case because the European Union’s moratorium violates WTO rules. The rules referred to are from the WTA agreement on sanitary and phytosanitary measures (SPS). This agreement recognizes that countries are entitled to regulate crops and food products to protect health and the environment, however members of this agreement must have “sufficient scientific evidence” to justify their regulatory policies and that these policies must be implemented without “undue delay[57].” Although the United States has filed this suit the U.S. Trade Representative Robert B. Zoellick states that “The United States will continue to work with the European Union to manage this and other disputes in an appropriate way, and... look forward to advancing... shared objectives...[58]” In reaching a compromise rather than battling each other in the legal sense the United States and Europe will have to find a happy medium.
The United States has kept the theme of stressing the focus of its regulation on the end product since it began enacting legislation during the Reagan Administration. The basis for this decision has been their belief in the theory that genetically modified products are low-risk because of their substantial equivalence to conventional foods. Another argument for treating genetically modified foods as low-risk is the theory that foods have been genetically modified for years. Plants have been cross-bred for size, heartiness, color, and a multitude of other traits that farmers or agriculturists believed to be beneficial. The genetic modifications that scientists insert are equivalent to the cross-breeding genetic modifications. The reason for maintaining a product based, low risk position has been to allow the technology to advance without legislative burden. The United States has been a leader in the field of biotechnology and in order to maintain their position the government opted to streamline regulation. By claiming that genetically modified products are substantially equivalent to conventional foods already on the market manufacturers can avoid the lengthy approval proceedings under the FDA and USDA. The streamlined process for approval reduces costs for manufacturers and the regulatory agencies. Manufacturers are not required to provide as much scientific evidence for approval and the federal agencies did not have to hire as many specialists to review and analyze the results. However, the FDA did begin to require mandatory consultations which increased the costs for manufacturers and the FDA.
The European Union has continued to focus its regulations on the process of creating genetically modified organisms rather than solely on the end product. This focus has been a cautious approach based on promoting safety rather than advancing technology. However, a benefit to maintaining this cautious approach is that the importation of food products from the United States will be much lower and that will drive up the price of European food products. By remaining cautious the European Union is also protecting its market. Additionally, there is a cultural argument for why the European Union is insisting upon such a conservative system. Europeans opposition to GMOs is believed to stem from their repulsion of the idea that the market is being taken over by multinational companies and that there is a power shift to the United States[59]. Most Europeans feel that “the last vestige of cultural identity ...they have some control over is their choice of food[60].”
When genetically modified organisms were first introduced in the European Union they were regulated by Directive 90/220/EC. Under this regulation the European Union approved nine agriculture biotech products for planting or import before 1999[61]. Under Direction 90/220/EC the commercial release of 18 GMOs has been authorized[62]. In 1998 the European Union enacted a moratorium on new approvals[63]. Since 2001, Directive 90/220/EC has been repealed by Directive 2001/18/EC which outlined a more intensive review and approval system[64]. The European Union has not approved any new GMOs since the moratorium enacted in 1998. As of July 1, 2003 the Commission has received twenty notifications[65] under Directive 2001/18/EC,[66] but has yet to approve any GMOs. Seven of these notifications are for products that were pending at the time that Directive 90/220/EC. Like the United States, the European Union allows GMOs to pass through a streamlined procedure if the food that has been derived from a GMO but longer contains GMOs and is considered “substantially equivalent” to existing food[67].
The European Union’s approval process runs against the grain of the United State’s policy. The European Union’s legislation creates a great burden on the introduction of GMOs onto the market and to scientific advancement. In order for the two to agree on a policy they will have to determine whether the United States should increase the legislation regulating GMOs or if the European Union should relax their legislation. The United States has the incentive to increase legislation regulation because it would open up trade with the European Union. However, this increased regulation would be costly and would be in opposition to promoting biotechnology. The incentives for the European Union to loosen its regulations are promoting biotechnology, avoiding law suits, and an increase in trade options. However, there are drawbacks such as cultural degradation, a drop in the value of European products, and a shift in power to parties outside of the European Union. In order for a compromise to occur gains and losses will have to be weighed and assumed by both parties.
Another issue that needs to be analyzed is the position of standards used to measure the safety of genetically modified foods. None of the regulatory measures issued by the United States formally outlines standards for measurable risks or what constitutes sufficient scientific evidence. The FDA publication “Guidance on Consultation Procedures for Foods Derived from New Plant Varieties” recommends information the manufacturer should supply at the FDA consultation. However, any data that is supplied is taken as accurate and is not validated. The FDA has admitted that randomly validating scientific evidence is feasible and is probably a regulatory change that should be implemented to ensure the safety of GM products entering the market[68].
The European Union has defined standards for certain regulations and directives. One example is the one percent de minimis threshold for the presence of DNA or protein resulting from genetic modification when determining whether or not a product should be labeled as a genetically modified organism[69]. In addition to requiring extensive scientific evidence of safety via notification under Directive 2001/18/EC the European Union also requires that post-market release analyses be conducted[70]. The requirements for notification are outlined for manufacturers in the above directive.
In order for the United States and the European Union to reach a compromise on the standards to be imposed it must first be determined what an adequate standard is and how much scientific evidence is needed. For the United States this will be a first and for the European Union it will be a continuation of what they have already started. In reaching a compromise having a factual and scientifically based standard should provide a solid launching point and reference for further compromise.
Another aspect that must be discussed is what types of genetically modified organisms should be regulated. United States has existing legislation regarding genetically modified foods, genetically modified feed, products of genetically modified origin, and products derived from genetically modified organisms. Through the approval process currently in place the United States does not grant a blanket approval to products that could be marketed as food and feed or anything else that crosses categories. Each product is approved on an individual basis including considering its intended use. However, this approach has caused difficulties and public concern. In 1998 the EPA approved Starlink™ Corn[71] for use as animal feed, but did not approve it for human consumption. This is an example of a “split” exemption, where a product is approved for one use, but not another. Because the EPA granted this split exemption Starlink™ was allowed to be grown and processed for feed. However, Starlink™ Corn is the first test case to show contamination of other crops[72]. Starlink™ has been found in Taco Bell taco shells and traces have been found in more than one percent of samples submitted by growers and grain handlers in the past 12 months[73]. Starlink™ is only one example of the danger of “split exemption” and of the dangers in the regulatory processes of the United States.
It appears that the United States is over-regulating because of the lack of evidence of anyone sustaining injury from consuming Starlink™ corn. This is a specific incident where luckily no one died from anaphylactic shock due to an allergic reaction to the GM corn. If you only look at the effect that GM foods may have on humans this appears to be a valid argument. However, one must look at the larger picture. For example, Bt corn is a GM corn that has been determined fit for human and animal consumption and is currently being grown in the United States. Like Starlink™ there have not been any reports of injury to humans caused by the GM corn. Although there is no negative affect to humans Bt Corn poses a “major hazard to Monarch butterflies[74].” One may argue that Monarch butterflies are a small price to pay for the advances in biotechnology, but scientists are now finding that Bt corn is also killing “lacewings, ladybugs, and beneficial soil microorganisms” which in turn is “damaging the entire soil food web[75].” Additionally, the last recall of a genetically engineered product (nutritional supplement I-Tryptophan in 1989) “left in its wake 37 deaths and 5,000 injuries[76].”Although evidence points to over-regulation on the surface, it is the unexpected that needs to be considered.
The United States’ method of regulating based on specific categories is erroneous. Even though one could argue that the basis for approving plants and products should be on different scales because the level of danger from each is dangerous is incorrect because you cannot separate the two. If you have a GM plant and the goal for the market is the product then you still have to produce that potentially dangerous plant to achieve the product. Additionally, even if both plant and product are regulated separately under the current system there are such grievous flaws as to allow unknown dangers such as gene transposition that are creating potentially dangerous immunities in insects and weeds. A system that allows the regulators to view the larger picture is needed so that the unobvious connections between different GM sources can be seen and dealt with accordingly.
The European Union also has legislation concerning genetically modified foods, genetically modified feed, products of genetically modified origin, and products derived from genetically modified organisms. However, the European Union does not allow “split” exemptions like the United States[77]. Also, all of these classifications of GM products undergo the same approval process by the same agencies. The only exception is that foods derived from GMOs that no longer contain any GMOs are subject to a simplified procedure[78]. In review Directive 2001/18/EC provides thorough and transparent guidelines concerning the release of GMOs into the environment, but it does not cover products that are derived from GMOs[79]. Products derived from GMOs are regulated by other policies such as the Regulation on Novel Foods and Novel Food Ingredients of January 27, 1997[80]. This regulation outlines rules for authorization and labeling of novel foods. The authorization procedure is the same as the approval process under Directive 200/18/EEC, except the Novel Food Regulation allows a simplified procedure for foods derived from GMOs, but no longer containing GMOs. In addition to being GMO-free the food must be substantially equivalent to existing foods[81]. Under the simplified procedure manufacturers are required to notify the Commission when placing a product on the market. In addition to notifying the Commission the manufacturer must provide scientific justification that the product is substantially equivalent or it is the opinion of the authorities of the Member State that the product is substantially equivalent[82]. The European Union recognized that by allowing “split” exemptions a situation similar to Starlink™ in the United States may have occurred. Additionally, the European Union’s system also allows for exports of GM foods from other countries as long as the GM derived food would receive approval under their system.
Due to the United States’ experience with Starlink™ it is feasible to believe that a compromise and what should be regulated and approved would be an easier task than compromising on some of the other issues explored. The choice here is whether to continue to use the United States’ system of approval or to use the European Union’s system of granting approval. The approval process under the European Union’s system is more streamlined than that of the United State’s under this approach. Not only to the point that it is a great deal more difficult for GMOs to receive approval, but also in the administration of the approval process. Rather than having three regulatory agencies monitoring what can or cannot be approved and for different uses there is a single approval process that goes through the same experts and authorities. This system reduces discrepancies and costs due to the decreased number of channels the product must pass through before approval.
The final issue under regulation is transparency. Currently, the United States does not publish a great deal of information about the current situation of regulation of GM products. What is being published is cryptic and hard to understand to a member of the general public. These facts have been recognized by representatives of the FDA[83]. FDA representatives have agreed that implementing a system that would allow the general public to access more information about current events with regards to genetically modified products would be beneficial in assuaging the public’s concerns[84]. The FDA has also conceded that introducing a more transparent system is easily implemented by requiring more information be released in published reports and by creating access via the internet[85].
The European Union currently has a transparent system like the one the United States may try to achieve. Information regarding the approval process a GMO is going through is posted and updated via a website[86].Here the public can access any information obtained about the GMO through the course of the approval process by visiting[87]. Additionally, the members of the public are encouraged to comment on the information on the website. This website is very informative and user friendly, which promotes use by the public and education about the subject.
Without meeting or discussing policy the United States and the European Union are beginning to reach a similar position with regards to transparency of regulation. The United States realizes that its regulatory procedures are not transparent enough and need to be amended in order to provide more information to the public. The European Union already recognized the importance of keeping the public informed on such a volatile subject and has made information readily available through the internet. A simple update in the United States system and an agreement on the exactly how much and what kind of information should be released would put the two trade powers in harmony.
Labeling is also a major issue that would have to be sorted out between the United States and the European Union if their policies were going to be harmonized or at least made similar enough to allow for free trade between the two. The issues that should be addressed are should labeling be required and if so what would be required to be labeled.
The United States believes that the answer to this question is no. Currently, there is no regulation requiring the general labeling of GM products. The only time a GM product requires labeling is when the GM product differs from its conventional counterpart significantly[88]. The reason the U.S. cites for deterring labeling is that it may cause confusion or be “false” or “misleading”. The U.S. does provide certain labels that may be used by manufacturers if they wish to voluntarily label their products.
The European Union on the other hand has required that GM products be labeled since 1997[89]. The label satisfies the consumer’s right for information and allows the consumer to make an informed decision when purchasing products[90]. From October 17, 2001 on Directive 2001/18/EC directs that it is the responsibility of the Member States to take the necessary measures to ensure labeling of GMOs as or in products[91]. Foods and food ingredients must be labeled under the Novel Foods Regulation and additives and flavorings must be labeled under Regulation (EC) 50/2000 as of January 2000 if DNA or protein of GMO origin is present in the final product[92]. A final proposal for the regulation of labeling GMOs and products produced by GMOs was release on July 25, 2001. This proposal would extend labeling to all GM food and feed regardless of whether or not GM DNA or proteins can be detected in the final product[93]. As of now, there is no specific legislation aimed at the labeling of GM feed or feed produced from GM products[94].
The issue of labeling is a difficult one for the United States to compromise on due to its existing legislation for GM foods as well as conventional foods. If a system of labels could be created that the United States did not consider being false or misleading and that system would comply with existing legislation. First, the United States and the European Union must agree that labeling is required and then decide on what should be labeled before trying to determine how the label should read.
The United States is also concerned with labeling foods that are traded outside of the European Union as well due to the trade agreements these countries may have with the European Union. If countries outside the European Union are receiving supplies from the United States that do not conform with the European Union’s standards the European Union may cease trades with these countries for fear of receiving contaminated articles or unlabeled products that originated in the United States. Therefore, without the proper labeling countries that trade with both the United States and Europe will most likely not accept those products for fear of losing its trade partners. Currently, the United States ships most of its agricultural exports to Asia and then the second most is the European Union. If the United States were to resist complying with the European Union’s labeling requirements they stand to lose a huge portion of the export market.
Once both have agreed that a label is required it must be determined how that label should read. Under United States law the label must not be false or misleading. Under European Union law enough information must be provided for the consumer to make an informed decision. A label reading “this product does not comply with European Union labeling requirements” would not provide much information for the consumer other than it is in some form a GM product. The United States may also consider such language misleading. The best solution would seem to be to affix a label reading what type of GM product the item is and then placing something like an FDA approval blurb, similar to a surgeon general’s warning, but a positive message. This way the United States avoids promulgating a label that appears negative and/or false/misleading and the European consumer can make an informed decision.
In order for the United States and the European to see eye to eye on the issue of regulating genetically modified products a compromise needs to be reached. One method of successfully achieving compromise is to begin working with neutral organizations. The World Trade Organization conducts policy reviews for the United States and the European Union. September 2001 the WTO reviewed the United States’ policy on trade. It states that the United States has made efforts to further liberalize agriculture and service in the WTO mandated negotiations[95].” This report also notes the United States’ concern over trade restrictions on GM foods. In 2002 the WTO conducted a review of the policies of the European Union. In this report the WTO noted that the European Union’s trading partners perceived their strict regulations as trade barriers. This raised concern about “preserving the viability of the international standard-setting process[96].” The recent changes to the European Union’s legislation were reviewed to ensure that they complied with the WTO rulings[97]. The WTO’s review of policy allows for the trade powers to express their views on each other’s policies and to ensure compliance with world standards. By checking to see where they stand in relation to one another the two trade powers can determine whether or not their policies will create an impasse.
In addition to conducting reviews the WTO allows for countries to bring disputes against one another[98]. As of August 2003, the United States has filed a dispute against the European Communities for “Measures Affecting the Approval and Marketing of Biotech Products” and has placed a “Request for the Establishment of a Panel by the United States[99].” Utilizing the dispute settlement process is good way to bring forth concerns and to expedite or force compromise. This measure will probably bring the United States and the European Union closer to a unified system.
Another method of creating compromise is by forming committees that are made up of representatives from the different specialties within the biotechnology field. The USDA’s Office of the Under Secretary for Research, Education, and Economics established the Advisory Committee on Biotechnology and 21st Century Agriculture, (“AC21”)[100]. This committee is made up of eighteen individuals from the biotechnology industry, the farming community, the seed industry, food manufacturers, commodity processors and shippers, environmental and consumer groups, academic researchers, and experts on bioethics and legal issues. This committee has been charged to provide information on the long-term impacts of biotechnology on the U.S. food and agriculture system[101]. This committee is also responsible for providing guidance to the USDA on individual biotechnology issues. The European Union has also developed committees like AC21 with the hopes of obtaining more information and guidance from all concerned members of the biotechnology field. Although gathering information from within is beneficial for determining what issues are raised by their citizens the United States and the European Union are still not working on a global scale. The British Medical Association (“BMA”)[102] has published a list of recommendation regarding the impact of genetic modification on agriculture, food, and health. One of their recommendations is that the different world governments should consult each other and support a review of the World Trade Agreement. The stated purpose of this unity is to ensure that it is the governments of the world, not biotechnology companies, are deciding whether countries “accept with, or without restrictions, the importation and use of GM seeds, plants, of foods[103].”
Both of the above proposals share the common theme of looking past one’s own policies and working as a group to come to a decision. By first establishing what each considers to be safe regulation within their own borders and then discussing these policies with each other the United States and the European Union can determine what they have to work with and exactly what aspects deserve their focus.
The political histories of the regulation of genetically modified products in the United States and the European Union show how the differences between the two policies have resulted in the current trade war. The United States has consistently updated regulations while sticking to these three original tenets that regulation for genetically modified products should be: 1) product based, 2) presume that the risk of genetically modification is low, or equal to that of the natural foods currently consumed, and 3) that the existing federal standards used are sufficient to be applied to genetically modified foods. The European Union has also remained true to its conservative and cautious regulation. They have focused on the process of creating GMOs and have listened and taken into account the concerns of their citizens.
The next step in advancing genetically modified food technology is to reach a compromise and overcome the current trade war. By combining the two stances of the United States and the European Union a very safe and socially aware policy would be created. However, a complete integration without any hiccoughs is only feasible in a perfect world. If the two trade powers would be willing to form joint committees with specialists from all different backgrounds in the biotechnology industry a well rounded and mutually beneficial policy may result. The key to success is utilization of the policies of the WTO and communication not only between experts, but between the countries involved. Trade would resume, starving people in Africa and other areas of the world would be fed, and the governments would reach their goals of providing a safe environment while at the same time promoting advancement.
Looking Towards the Future
Advances in genetic engineering are occurring more and more often as scientists learn more about how genes work and more plants and animals are sequenced. Within the next 50 years a majority of animals and plants should be sequenced and their genetic code understood. This would allow scientists a greater realm of genes to experiment with during engineering. There will be better genes for drought resistance, pest resistance, nutritional value, growth factors, and much more. However, with these advances also come some of the difficulties that have already been encountered.
One is the ability for plants to transfer the genetically engineered “superior gene.” There have been lawsuits against farmers who have stolen the new gene because the engineered plants cross-pollinated with the neighboring crops. If genetic engineering is going to become a more popular choice in the United States it is plausible that many more cases like this will start popping up. This sort of “theft” will have to be classified and regulations pertaining to this “theft” will have to be developed. Some factors that may be considered in such cases are whether or not the farmer using the genetically engineered crops took precautions to prevent cross-pollination, whether notice was posted so that farmers not using genetically engineered crops would take precautions to prevent cross-pollination, and what volume of cross-pollination would constitute willful theft. A solution to “pollination theft” would be to contain crops in green houses so that only a minimal amount of pollen and genetically modified plant stuffs would leave the buildings with the workers. This is a costly solution, but since we already pay farmers to not produce crops the government could help subsidize the cost of building containment facilities. Another more scientific solution would be to engineer the plants so that they do not create pollen or engineer them so that they are sterile. Currently, there are sterile plants on the market, i.e. seedless grapes and seedless watermelon.
Another consideration for the future will be the damaging effects of the genetically modified plants on other plants, insects, and the environment in general. Currently, as stated above some plants, such as Bt Corn, are having an adverse affect on insects and the soil environment. If this trend were to continue into the future food chains and bionetworks could be destroyed, eventually having a horrific effect on the ecosystem. However, it is unlikely that scientists will allow this situation to progress to this extreme. One possible solution would be to produce suppressor genes that would suppress the genetic modifications that are causing the adverse affects. The benefit of using this type of gene would be that scientists could try to pinpoint the genes that are causing adverse affects and then manipulate another gene to turn that specific one off completely or to the point that it will no longer cause harm. A potential disaster with this solution is that the suppressor genes will over-suppress. They will weaken the plants that were engineered to be stronger, more resistant. In this case, suppressors themselves could also cause harm to the environment by passing on the suppressor genes and making natural plants weaker and more susceptible to the elements.
The best solution would be to have a stricter monitoring system or having more conscientious scientists. The only true way to ensure that GMOs don’t adversely affect the environment is to impose stricter regulations on when, where, and how these GMOs can be released into the environment.
The future of labeling in the United States will depend on whether or not the organic and all-natural fad continues into the future. Due to the new health-consciousness of the American public it is probable that the trend will continue for some time. Currently, the extent of labeling only extends to organic foods. One store, Trader Joes, informs its customers on its websites that customers can avoid non-organic or genetically modified foods by choosing foods that are labeled “organic.”[104] Because of the government’s opposition to labeling due to the negative implications it may have, it is plausible that only organic foods will continue to be labeled. This would solve some trade agreements with the European Union because they could agree to accept all foods that are labeled as organic.
One futuristic solution would be to have all foods and products sequenced. The European Union could then sample all imports and match their sequences to known sequences to see if the imports would comply with their standards. If the imports comply they could be released into the market unlabeled. Any imports that do not comply with the correct sequences would be destroyed. Another possible solution would be to label the products as sterile. If it is possible to created plants and products that cannot share genes and therefore there is no “jumping” of the genes then labeling them “sterile” should comply with the European Union’s regulations.

[1] The term genetically modified will be used rather bioengineered. The public is more familiar with the term genetically modified. However, the scientific community is more likely to use the term bioengineered. For ease of reading the term genetically modified will continue to be used.

[2] Meron Tesfa Michael, Africa Bites the Bullet on Genetically Modified Food Aid, World Press Review, (September 26, 2002), available at

[3] Biotechnology companies may soon have the ability to insert terminator genes into the gene sequence of plants. This terminator gene prevents the plants from producing seeds that could be used for a crop for the next season. Therefore, farmers would be required to buy the seeds from the biotechnology companies every year. See supra note 2.

[4] 44 B.C. L. Rev. 733,733

[5] Id.


[7] 44 B.C. L. Rev. 733, 738

[8] Coordinated Framework for the Regulation of Biotechnology, 52 Fed. Reg. 23,302 (proposed June 26, 1986)

[9] Principles for Federal Oversight, of Biotechnology: Planned Introduction Into the Environment of Organisms With Modified Hereditary Traits, 55 Fed. Reg. 31,118 (proposed July 31, 1990).

[10] Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of Biotechnology Products into the Environment, 57 Fed. Reg. 6753 (proposed Feb. 27, 1992).

[11] Id.

[12] See supra note 9

[13] Id.

[14] See supra note 10 at 6755

[15] Federal Food, Drug, and Cosmetic Act § 342(a)(1), 21 U.S.C.S. § 321 (2003).

[16] 21 C.F.R. § 170.3(i)(2003).

[17] 21 C.F.R. U.S.C. § 321(s).

[18] Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. 22,984 (proposed May 29, 1992)

[19] Premarket Notice Concerning Bioengineered Foods, 66 Fed. Reg. 4706, 4708 (proposed Jan. 18, 2001) (codified at 21 C.F.R. 592)

[20] Id.

[21] Id.

[22] Id. at 4707

[23] 67 Fed. Reg. 50,578 (Aug. 2, 2002).

[24] Id. at 50, 579

[25] Center for Food Safety and Applied Nutrition, FDA, Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have No Been Developed Using Bioengineering (Jan. 2001) (draft), available at

[26] Mandatory labeling would be required in cases where the nutritional value was completely different than that of its conventional counterpart or if its safety differed substantially. Id.

[27] Id.


[29] Id.

[30] 7 U.S.C. § 150aa-jj (repealed 2000).

[31] Id.

[32] Genetically Engineered Organisms and Products; Notification Procedures for the Introduction of Certain Regulated Articles; and Petition for Nonregulated Status, 57 Fed. Reg. 53,036 (proposed Nov. 6, 1992) (to be codified at 7 C.F.R. pt. 340).

[33] Genetically Engineered Organisms and Products; Simplification of Requirements and Procedures for Genetically Engineered Organism, 62 Fed. Reg. 23,945 (May 2, 1997) (codified at 7 C.F.R. §§ 340.0, 340.3).

[34] 7 U.S.C. § 136 (2000).

[35] Proposed Policy; Plant-Pesticides Subject to the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug and Cosmetic Act, 59 Fed. Reg. 60,496 (Nov. 23, 1994).

[36] Id. at 60,501

[37] Hearing on Plant Genome Science, Sub-comm. On Basic Research of the House. Comm. On Science, 106th Cong. (Oct. 19, 1999) (testimony of Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs, EPA)

[38] 7 U.S.C. § 136 (2000)

[39] 40 C.F.R. § 152.3 (2003)

[40] Question and Answer on the regulation of GMOs in the European Union, Memo/02/160 – Rev., Brussels, (July 1, 2003).

[41] Id.

[42] Council Directive 2001/18/EC 2002

[43] Question and Answer on the regulation of GMOs in the EU, Memo/02/160 – Rev., Brussels, (July 1, 2003).

[44] Id.

[45] Id. at 3

[46] Information for the public can be found at Memo/02/160 – Rev. pg. 3

[47] See Supra note 40

[48] Commission Regulation (EC) 258/97

[49] Id.

[50] Substantial equivalence applies to composition, nutritional value, metabolism, intended use, and the level of undesirable substances present. Id.

[51] Id.

[52] Commission Regulation (EC) 1139/98

[53] Commission Regulation (EC) 50/2000

[54] Commission Regulation (EC) 49/2000

[55] Question and Answer on the regulation of GMOs in the EU, Memo/02/160 – Rev., Brussels, (July 1, 2003).

[56] Office of the United States Trade Representative, Executive Office of the President Washington, D.C. 20508, U.S. and Cooperating Countries File WTO Case Against EU Moratorium on Biotech Foods and Crops, (May 13, 2003), available at

[57] Id.

[58] Id.

[59] Available at

[60] Vatican Prepares Statement on GMOs as National Debates Continue, (October 4, 2003) available at

[61] See supra note 56

[62] Question and Answer on the regulation of GMOs in the EU, Memo/02/160 – Rev., Brussels, (July 1, 2003).

[63] See supra note 66

[64] Council Directive 2001/18/EC 2002 O.J. (L???)

[65] Id.

[66] Question and Answer on the regulation of GMOs in the EU, Memo/02/160 – Rev., Brussels, (July 1, 2003).

[67] Commission Regulation (EC) 259/97


[69] Commission Regulation (EC) 49/2000

[70] Council Directive 2001/18/EC 2002 O.J. (L???)

[71] StarLink™ is a corn variety that has been genetically modified to contain an insecticidal protein derived from a naturally occurring bacterium (Bacillus thuringiensis, or Bt.) available at

[72] Alejandro E. Segarra and Jean M. Rawson, StarLink™ Corn Controversy: Background, (January 10,2001), available at (last viewed

[73] Paul Jacobs, Banned GE StarLink Corn Still Contaminating 1% of U.S. Corn Crop, (December, 1, 2003), available at

[74] Ronnie Cummins, Starlink: More Bad News for Biotech, (December 2000) available at

[75] Id.

[76] Id.

[77] Question and Answer on the regulation of GMOs in the EU, Memo/02/160 – Rev., Brussels, (July 1, 2003).

[78] Id.

[79] See Supra note 40

[80] Commission Regulation (EC) 258/97

[81] Substantial equivalence applies to composition, nutritional value, metabolism, intended use, and the level of undesirable substances present. Id.

[82] Id.


[84] Id.

[85] Id.

[86] Question and Answer on the regulation of GMOs in the EU, Memo/02/160 – Rev., Brussels, (July 1, 2003).

[87] Available at

[88] Center for Food Safety and Applied Nutrition, FDA, Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have No Been Developed Using Bioengineering (Jan. 2001) (draft), available at

[89] Question and Answer on the regulation of GMOs in the EU, Memo/02/160 – Rev., Brussels, (July 1, 2003).

[90] Id.

[91] Id.

[92] Commission Regulation (EC) 50/2000

[93] See Supra note 89

[94] See Supra note 89


[96] Id.

[97] Id.

[98] A dispute arises when a member government believes another member government is violating an agreement or a commitment that it has made in the WTO. The authors of these agreements are the member governments themselves — the agreements are the outcome of negotiations among members. Ultimate responsibility for settling disputes also lies with member governments, through the Dispute Settlement Body. Available at

[99] Catalogue Record WT/DS291/23

[100] Advisory Committee on Biotechnology and 21st Century Agriculture (AC21), (April 15, 2003), available at

[101] Id.

[102] The British Medical Association is a professional association of doctors, representing their interests and providing services for its 128,000 members. This includes nearly 4,000 from overseas and 14,000 medical students. Available at

[103] Id.

[104] Available at