Genetic Engineering and Third World Countries
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[i] 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.[ii] 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.[iii]
Two Different Positions: The U.S. v. the EU
As illustrated by the passage above, the United States and the European Union ("EU") 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.[iv] 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 EU 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 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 purpose for initiating regulation was to protect the safety of the "citizens’ health and the environment while simultaneously creating a unified market for biotechnology[v]." 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[vi]. 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[vii].
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[viii]. 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[ix]. 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 [x]. The public is kept informed during this process via the internet[xi].
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[xii]. Products derived from GMOs are regulated by other policies such as the Regulation on Novel Foods and Novel Food Ingredients of January 27, 1997[xiii]. 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[xiv]. 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[xv]. 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[xvi].
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[xvii]. Regulation EC 50/2000 requires that final products that contain additives and flavorings that contain DNA or proteins from GMO origins be labeled[xviii]. 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[xix].
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[xx]. This proposal is meant to address continuing concerns on the behalf of the industry and consumers.
Labeling Genetically Modified Foods
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 is requires labeling is when the GM product differs from its conventional counterpart significantly[xxi]. 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 EU on the other hand has required that GM products be labeled since 1997[xxii]. The label satisfies the consumer’s right for information and allows the consumer to make an informed decision when purchasing products[xxiii]. 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[xxiv]. 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[xxv]. 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[xxvi]. As of now, there is no specific legislation aimed at the labeling of GM feed or feed produced from GM products[xxvii].
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. However, if a system of labels could be agreed upon they would not be considered false or misleading and would therefore comply with existing legislation. First, the United States and the European must agree that labeling is required and then decide on what should be labeled before trying to determine how the label should read.
[i] 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.
[iii] Biotechnology companies 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.
[iv] 44 B.C. L. Rev. 733,733
[v] Question and Answer on the regulation of GMOs in the EU, Memo/02/160 – Rev., Brussels, (July 1, 2003).
[vii] Council Directive 2001/18/EC 2002
[viii] Question and Answer on the regulation of GMOs in the EU, Memo/02/160 – Rev., Brussels, (July 1, 2003).
[x] Id. at 3
[xii] See Supra note 40
[xiii] Commission Regulation (EC) 258/97
[xv] Substantial equivalence applies to composition, nutritional value, metabolism, intended use, and the level of undesirable substances present. Id.
[xvii] Commission Regulation (EC) 1139/98
[xviii] Commission Regulation (EC) 50/2000
[xix] Commission Regulation (EC) 49/2000
[xx] Question and Answer on the regulation of GMOs in the EU, Memo/02/160 – Rev., Brussels, (July 1, 2003).
[xxi] 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 http://vm.cfsan.fda.gov/~dms/biolabgu.html.
[xxii] Question and Answer on the regulation of GMOs in the EU, Memo/02/160 – Rev., Brussels, (July 1, 2003).
[xxv] Commission Regulation (EC) 50/2000
[xxvi] See Supra note 80
[xxvii] See Supra note 80