How are GMOs regulated?
Published on November 26, 2001

Overview

Foods derived from biotechnology have led to safety concerns with regard to human and animal health, as well as the environment in general. Concerns for human health include the risks of transferring toxins from one life form to another, of creating new toxins, or of transferring allergenic compounds from one species to another, which could result in unexpected allergic reactions. There are also concerns about the effects that biotechnology products could have on farm animals. Therefore, it is important to understand the system under which Genetically Modified Organisms (GMOs) are regulated. A report released recently under the successive E.C. Framework Programs for Research and Technological Development from 1985 to 2000, on October 9, 2001, "suggests that GM foods may be even safer than regular foods due to the extensive system in which they are regulated," said Paul Geitner, a writer for the Associated Press.

The United Nations (U.N.)

The U.N. Food and Agriculture Organization (FAO) and the World Health Organization (WHO) publish recommendations to strengthen the process used to protect consumers from the risk that some genetically modified organisms (GMOs) could pose. FAO/WHO consultations work to establish a consensus among scientists who participate in the consultations based on their scientific expertise. The recommendations made by the Joint Expert Consultations are presented to the Intergovernmental Task Force to help formulate a global consensus on the safety and nutritional aspects of foods derived from biotechnology. The Codex Alimentarius Commission establishes international standards, guidelines or other recommendations known as Codex Alimentarius, through deliberations among representatives of Codex Members, which includes 165 countries.

• The International basis for safety assessments is the scientific principles standardized though the World Health Organization (WHO), Food and Agriculture Organization (FAO) and the Organization for Economic Co-operation and Development (OECD).
• The Biosafety Protocol (also know as the Cartagena Protocol): allows countries to ban GMOs based on the Precautionary Principle, which is the unknown risk GMOs may cause
• CODEX: Heads the task force on foods derived from biotechnology and the Committee on Food Labeling

World Trade Organization (WTO)

The issue of GMOs has caused great problems within the WTO, whose laws and regulations are solely based on scientific evidence. Recently, the U.S. and Canada enquired about the E.U.'s restrictions on genetically modified organisms (GMOs). They complained that the E.U. had failed to notify its latest directives on traceability and labeling under Sanitary and Phytosanitary Measures (SPS), even though these indicate that health protection is one of the objectives.

The U.S. also complained about the lack of scientific justification for the E.U.'s continued de facto moratorium on the approval of GMO products, and Canada said the latest E.C. measures discriminate against products produced by biotechnology, even where no traces remain in the final products. The E.C. delegation defended its measures, stressing that labeling and traceability issues were already under discussion in the Technical Barriers to Trade Committee, but did not object to them being further considered by the SPS Committee.

• Protects the U.N. initiative on food safety, providing that any protectionist measures are guaranteed with scientific evidence, under the Agreement on Sanitary and Phytosanitary Measures (SPS) and the Agreement on Technical Barriers to Trade (TBT).

United States of America (US)

The United States Department of Agriculture (USDA) is one of three Federal Agencies, along with the Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA), primarily responsible for regulating biotechnology in the United States. Products are regulated according to their intended use, with some products being regulated under more than one agency.

EPA:

• Federal Insecticide, Fungicide and Rodenticide Act (FIFRA): Ensures the safety of pesticides for the environment
• Toxic Substance control Act: Regulates the commercialization of genetically engineered microorganisms

USDA: Animal and Plant Health Inspection Service (APHIS), protects U.S. agriculture from pests and diseases

• The Federal Plant Pest Act: evaluates the possible impact of organisms and products produced by means of genetic modification prior to their introduction to other plants and plant pests in the ecosystem
• Authorizes field tests for GM crops

FDA:

• Federal Food, Drug and Cosmetic Act: Regulates genetically engineered organisms, which are intended for use in food or feed products

European Union (E.U.)

E.U. legislation is generally based on international standards and guidelines developed by specific international institutions as recommended in the WTO agreement on SPS measures. Although this situation may potentially constrain exports to the E.U., under WTO regulations recourse to national legislation is permitted provided that certain conditions are met, in particular SPS measures should be based on scientific justification and on the accurate assessment of risks involved and should not be more trade-restrictive than required.

Directive 90/219/EEC: regulates the continued use of genetically modified microorganisms for research and industrial purposes.

Directive 90/220/EEC: regulates deliberate release for research and development and the placing of the market products intended for subsequent deliberate release. The scope of the directive included products consisting of, or containing GMOs (like GM tomatoes), not derived products, such as tomato paste or ketchup.

• Importers must submit a notification before placing a GMO on the market
• Notification should contain a technical dossier including a full risk assessment. In the case of a negative evaluation the notification is rejected
• The dossier is forwarded to the E.C., who has the right to raise objections. The original evaluation grants the consent for placing the product on the market
• In the case of objection, the Commission seeks the opinion of its Scientific Committees, who decide by qualified majority. If no Council decision is taken within three months the Commission takes the decision. In accordance with the derivative, the Commission is ultimately obliged to adopt measures to authorize a GMO if the application fulfils current E.U. legislation and if it is not rejected by unanimity in the council, or if the Council fails to act within the fixed deadline.
• Scientific assessment of risks to human health and the environment must be conducted before receiving Community authorization.
• How the GM was developed
• Risk associated with the gene products in the plant, mainly proteins
• Investigation of the possibility that the inserted gene may be transferred to bacteria.

Directive 98/95/EEC: covers labeling of seeds

Directive 99/34/EEC: producers or importers are liable for defective products that cause damage to health

Regulation (EC) 258/97: Novel Foods and Novel Food Ingredients: regulates authorization and labeling

• Assessment by Member State where the food is to be placed on the market
• If there is no objections by the Commission, the first Member State can authorize for the whole Community and the product can circulate freely in the Single Market
• If there are objections, a Commission Decision, following consultation of the Scientific Committees, will take place
• Companies have to notify the Commission when placing a product on the market together with either scientific justification that the product is substantially equivalent or an opinion to the same effect. The product can then be marketed in the entire E.U.

Regulation (EC) 1139/98: model for labeling in the E.U.

Regulation (EC) 49/2000: -1 per cent labeling threshold for material of GMO origin

Regulation (EC) 50/2000: labeling requirements for foodstuffs and food ingredients containing additives and flavoring derived from GMOs In the E.U., some Member States (Austria, Luxembourg, France, Greece and Germany) have invoked Article 16 of 'safety clause' of

Directive 90/220/EEC to temporarily ban the placing on the market of genetically modified products in their territories. These cases have been transmitted to the Scientific Committee on Plants for opinion. In all cases, the Committee deemed that the information submitted by Member States did not justify their bans.

THAILAND

• At present, all transgenic crops will be tested, however, they cannot be introduced on a commercial scale.
• Plant Quarantine Act BE 2507 (1964), under the Ministry of Agriculture and Cooperatives, prohibits for genetically modification 40 seeds for any use except research.
• The Thai Food and Drug Administration is drafting Guidelines on Safety Assessments of Genetically Modified Foods (GMFs) to be used as a criteria for safety assessments prior to the approval of GMFs to be produced, distributed or imported from foreign countries.

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