Codex Ad Hoc Intergovernmental Task Force On Foods Derived From Biotechnology

codex alimentarius commission FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS WORLD HEALTH ORGANIZATION JOINT OFFICE: Viale delle Terme di Caracalla 00100 ROME Tel: +39(06)5701 Telex: 625825-625853 FAO I Email: Codex@fao.org Facsimile: +39(06)5705.4593 Agenda Item 4 CX/FBT 00/4 Part II February 2000 JOINT FAO/WHO FOOD STANDARD PROGRAMME CODEX AD HOC INTERGOVERNMENTAL TASK FORCE ON FOODS DERIVED FROM BIOTECHNOLOGY First Session Chiba, Japan, 14-17- March 2000 CONSIDERATION OF THE ELABORATION OF STANDARDS, GUIDELINES OR OTHER PRINCIPLES FOR FOODS DERIVED FROM BIOTECHNOLOGY Document CX/FBT 00/4 reproduces comments and/or information submitted by Governments and international organizations in response to Circular Letter CL 1999/27-FBT. Part II of Document CX/FBT 00/4 (this document) contains information relating to national and regional experiences with foods derived from biotechnology. This documents includes information submitted by Argentina, Brazil, Canada, Denmark, Hungary, Singapore, South Africa and United States of America. CX/FBT 00/4 Part II page 2 ARGENTINA INTRODUCTION 1. The Argentine Republic has a three-stage system of approval for the evaluation of genetically modified organisms. 2. The first stage concerns the advisability of release into the environment and is conducted by the National Advisory Commission on Agricultural Biotechnology (CONABIA). 3. The second stage comprises an evaluation of suitability as food and feed and is conducted by the National Food and Agriculture Safety and Quality Service (SENASA). 4. The third stage is the preparation of a market report by the National Food and Agricultural Commodity Market Authority (D.N.M.A.) ARGENTINE SYSTEM OF EVALUATION OF GENETICALLY MODIFIED ORGANISMS 5. CONABIA is an advisory commission made up of representatives of government bodies and private organizations. 6. Its function is to examine the modification process from the perspective of agro-ecological impact and the environment, leading to a recommendation regarding release into the environment. 7. SENASA examines the modification process from the point of view of safety and suitability as food and feed. 8. This study is based on a series of short-, medium- and long-term toxicological evaluation criteria, on allergenic, teratogenic, mutagenic and carcinogenic admissibility and on the biological availability of macro- and micronutrients, depending on the intended use of the transgenic material or food. 9. Failure to meet any of these requirements must be scientifically justified by the company responsible for the genetic modification. 10. In conjunction with these studies, which may be carried out concurrently, the D.N.M.A. looks into the possibility of placing the resulting products on national and international markets. 11. The Secretary of State for Agriculture makes a final decision on the basis of the CONABIA, SENASA and D.N.M.A. reports, either allowing commercial release or rejecting the process. 12. Secretary of State for Agriculture, Livestock, Fisheries and Food Resolutions N° 289/97 and 511/98 are attached. Summary of the RESOLUTION 289/97 RESOLUTION 289/97 regulates the issue of authorizations for the trial and/or release into the environment of Genetically Modified Plant Organisms. The Secretary of State for Agriculture, Livestock, Fisheries and Food is the competent authority for the authorization of the trial and/or release into the environment of Genetically Modified Organisms (GMOs), based on the report of the National Advisory Commission on Agricultural Biotechnology (CONABIA). The trial and/or release into the environment of GMOs is conditional upon completion of an application comprising: 1. summary 2. form CX/FBT 00/4 Part II page 3 3. additional information 4. standards Authorization shall be granted for: A) the conduct of a laboratory/greenhouse trial B) the conduct of a field trial C) the pre-commercial multiplication of the plant material Once the application has been evaluated, the CONABIA shall determine the advisability or otherwise of authorizing the release of the GMO and shall report its conclusion to the Secretary of State for Agriculture. Those applicants who have already received an authorization for the trial and/or release into the environment of GMOs may request a relaxation of conditions attached to authorization, by note to CONABIA. The authorized relaxation of conditions does not imply authorization to commercialize the seed. Commercialization is conditional upon: A) prior authorization of relaxation of conditions. B) fulfilment of INASE requirements for registration of the material on the national register of cultivars and with the inspectorate body. C) compliance, where applicable, with SENASA requirements for the authorized commercialization of agro-chemicals. D) request, by means of a note addressed to CONABIA, for SENASA to initiate procedures for compliance with its requirements for utilization of the material as food and feed. E) The National Food and Agricultural Commodity Market Authority shall carry out a technical appraisal of the advisability of releasing the transgenic material on the market. F) After completion of the above steps, CONABIA shall draw up a final report for submission to the Secretary of State for Agriculture for final decision. Summary of the RESOLUTION 511/98 REQUIREMENTS AND CRITERIA FOR EVALUATION OF GMOs Requirements: A) Fulfilment of the criteria listed below. B) Existing approval in other countries. C) Consultations with recognized national scientific bodies on toxicological risks and/or safety of the product, should this be necessary. D) Responsibility of business corporations for compliance of their GMOs. E) The GMOs can be re-evaluated periodically. Criteria: 1) Natural toxic substances. CX/FBT 00/4 Part II page 4 2) Toxic substances of new expression. 2.1.)Short- and medium-term toxicological, allergenic, carcinogenic and teratological character trials. 2.1.1.) Absorption, distribution and biotransformation of “in vitro” or “in vivo” chemical substances. 2.1.2.) Experimental toxicity trials with animals. 2.1.3.) Medical toxicology. 2.1.4.) Forensic toxicology. 3) Similarity of the transgenic product with known allergens. 4) Nutritional modifications. Additional information The English version of the full text of Resolution 289/97 can be found on the following Web site: http://www.sagyp.mecon.ar , and then CONABIA, English version. References 1. OCDE 1992 Biotechnology, Agriculture and Food (93.92.03.1) ISBN 92-64-13725-4. 2. FAO/OMS 1992. Estrategias para evaluar la Inocuidad de los Alimentos Producidos por biotecnología. ISBN 92-4-356145-6. 3. Guideline for Safety Assessment of foods and Foods Aditives Produced by recombinant DNA Techniques (Draft revision) 1996. First National Organizations Divisions, Japan. 4. 90/219/EEC. Council Directive of 23 april 1990. 5. 90/220/EEC. Council Directive of 23 april 1990. 6. Alinorm 95/22. Informe de la 23ava. Reunión del Comité del Codex sobre Etiquetado de los Alimentos. 7. ANZFA, febrero 1997 Assessment Guidelines for Food and Food Ingredients to be included in Standard A 18 – Food Derived from Gene Technology. 8. OMS, 1995 application of the Principles of sustantial Equivalence to the Safety Evaluation of Foods or Food Components from Plants Derived by Modern Biotechnology. 9. FDA, 29 de mayo de 1992. Statement of Policy: Foods Derived from New Pllants Varieties. 10. OCDE, 1992. Safety Evaluation of Foods Derived by Nodern Biotechnology: Concepts and Principles. 11. OCDE, 1995. Proceedings of the OECD. Workshop on Food. Safety Evaluation. Final Agree. Text. 12. Biotechnology and Food Safety. Informe de una Reunión Consultiva mixta FAO/OMS 1996. 13. Guidelines for the Safety Assessment of Novel Foods; Vol I y II. Food directorate – Health Protection branch. Health canada – september 1994. 14. Food Derived from New Varieties Consultation Procedures. Biotechnology Policy Branch FDA – USA. Junio 1996. CX/FBT 00/4 Part II page 5 BRAZIL 1. Brazil has a Biosafety Legislation that is set forth in the Enforcing Act items II and V of Paragraph 1, Article 225 of the Federal Constitution, which sets standards for the use of genetic engineering techniques and for the environmental release of genetically modified organisms, and authorizes the Executive Power to create the National Technical Commission on Biosafety, and provides for other measures. 2. The National Technical Biosafety Commission (CTNBio) which is linked to the Ministry of Science and Technology was instituted in 1995, by the Law number 8974,January 5,and is composed of 8 scientists from different areas and representatives of Ministries of Health, Agriculture, Environment, External Affairs, Education, Science and Technology, Justice (Consumer Protection) and one representative of private sectors entities. The main objectives of CTNBio are: to propose the National Policy on Biosafety, to accompany the technical and scientific development on Biosafety and in kindred areas, aiming the consumers and population' safety in general, with permanent care to the environment protection - atmosphere; to establish standards and regulations related to the activities and projects which contain construction, cultivation, manipulation, use, transport, storage, commercialization, consumption, liberation and release related to organisms genetically modified (OGM). The complete text of the Law 8974 is in our web site www.mct.gov.br/ctnbiotec/default.htm. CANADA Introduction 1. Under the Food and Drugs Act and Regulations, Health Canada is responsible for provisions related to public health, food safety and nutrition. Health Canada’s responsibility regarding food is to establish science-based policies and standards ensuring that all foods on the Canadian market are safe and nutritious. 2. In recent years, a variety of new foods are being developed and introduced into the Canadian marketplace, including foods that have been modified from their traditional composition using new techniques such as biotechnology. Health Canada has recently promulgated Novel Foods Regulations under the Food and Drugs Act in order to address the safety of such new foods and food ingredients. These Novel Foods Regulations define the concept of a "novel food" and requires notification prior to the sale or advertising for sale of such products in Canada. This permits Health Canada to conduct a thorough safety assessment for each product. 3. Since 1994, forty-three genetically modified products were assessed and considered acceptable for sale in Canada. The majority of these products are crop plants e.g., corn, canola, soybean, and potato that have been genetically modified to improve agronomic traits including insect and virus resistance and herbicide tolerance. 4. The Canadian approach to safety assessment is based upon the concept of substantial equivalence and follows principles developed by an international committee of experts working through the Organization for Economic Cooperation and Development (OECD). As the science of biotechnology evolves, Health Canada continues to keep pace by using the best technology available at the moment and by continually reviewing the effectiveness of its approach. The Department continues to play an active role in international fora (WHO, FAO, OECD) to share expertise in developing assessment strategies and to ensure that Canada’s strategies are based upon the best available science. The Department is committed to strengthening its regulatory and oversight role regarding the assessment and approval of genetically-modified foods to ensure protection of the health and safety of Canadian consumers. CX/FBT 00/4 Part II page 6 5. The importance of regulatory cooperation in the area of biotechnology is recognized and desirable. As the number and complexity of food products derived from biotechnology increases, the need for international harmonization of approaches to food safety assessment becomes increasingly evident. This will facilitate the review process through the use of a single consistent approach to providing guidance for the assessment of biotechnology-derived foods. The realization of harmonized approaches to food safety assessment will continue to ensure the safety and nutritional quality of foods derived from biotechnology in the global market and may also lead to mutual acceptance of product assessments in the future. Canadian Safety Assessment of Biotechnology-Derived Foods 6. The approach to the safety evaluation of novel foods is conducted according to the Guidelines for the Safety Assessment of Novel Foods prepared by Health Canada and which are based on the Organization for Economic Cooperation and Development (OECD) approach of substantial equivalence. Substantial equivalence embodies the concept that, if a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety. These Guidelines are flexible in that they allow the waiver of data requirements that are not relevant to the product under consideration. This is important considering the broad range of products that are being developed. 7. As is the case for approval of other products (such as food additives) by regulatory agencies around the world, companies or proponents of biotechnology-derived foods are required to submit a set of data which must be of sufficiently high caliber and meet the criteria specified in the guidelines. This information is reviewed by a team of scientific evaluators representing expertise in molecular biology, toxicology, chemistry, nutritional sciences and microbiology. The scientific validity of study protocols used, as well as the raw data submitted, are critically analyzed. 8. The approach is sequential. It begins with a review of the information available on the development of the modified plant itself followed by a characterization of the actual product. The safety assessment of foods derived from biotechnology considers: • how the food crop was developed, including the molecular biological data which characterizes the genetic change; • composition of the novel food compared to non-modified counterpart foods; • nutritional information for the novel food compared to non-modified counterparts; • potential for new toxins; and • potential for causing allergic reaction 9. The safety assessment proceeds through the sequence until a conclusion of substantial equivalence can be reached, at which point the modified product would be treated the same as its traditional counterpart. Where substantial equivalence can be demonstrated before the need to look at nutritional data and toxicological data, both the time required for approval and the cost to develop a data package for approval can be reduced. This does not mean that biotechnology-derived foods are approved if they are “substantially equivalent” to their traditional counterparts. What this approach means is that biotechnology-derived foods are assessed against their traditional counterparts which have been safely consumed in the human diet for a prolonged period. The comparative approach permits linking the composition of the new food to existing products with a history of safe use, permitting prediction of the impact of the new food in the diet. Differences identified in the comparison are the focus for further intense scrutiny which involves traditional nutritional, toxicological and immunological testing, as appropriate. If the assessment indicates that longer term studies are required, the food will not be approved and the organization applying for approval will be required to undertake the longer term studies and submit additional data before their application is further considered. 10. The safety assessment further focuses on the novel trait or component introduced to foods using genetic modification. These novel traits or components are then assessed using the full range of CX/FBT 00/4 Part II page 7 methods which consider the impact of the new trait or component in the modified organism, characteristics related to the new trait or component in the final food in terms of nutritional quality, the potential that the new component may be a toxicant or reduce the nutritional integrity of the food product, and its potential allergenicity. Additional research or testing is required if scientists are not satisfied at any stage in the safety assessment process. Only if all of Health Canada’s stringent criteria are met is a novel food allowed access to the Canadian market. 11. Further information on Health Canada Decisions taken on new products, Novel Food Decision Summaries for each new product, the Novel Foods Regulation, the Guidelines for the Safety Assessment of Novel Foods, along with fact sheets and answers to frequently asked questions are available on Health Canada’s website. (http://www/hc-sc.gc.ca/food-aliment) DENMARK Danish and EC regulation on genetically modified foods 1. Long before an initiative was taken at European Community level to regulate genetically modified foods national legislation was adopted in Denmark to make sure that no genetically modified foodstuff was allowed on the market unless it had been authorized by the Danish authorities. This national regulation remained in existence from 1986 and until it was repealed by the EC Novel Foods Regulation (Regulation 258/97 of 26 January 1997), which came into force on May 15, 1997. 2. The early interest on the part of the Danish political scene as well as of Danish consumers in the issue of foods produced by means of gene technology was the reason why Denmark was one of the first countries to introduce a pre-market authorization for such foods. 3. The fact that this national regulation was in force in Denmark meant that the complete application concerning the food use of the Monsanto glyphosate tolerant soybeans was sent to the Danish authorities for assessment in 1996. Later, in 1997, the application concerning the food use of Novartis maize was assessed by the Danish national experts in toxicology and nutrition. Both the soybeans and the maize were authorized following the assessment. 4. For many years the Danish experts in question have been taking part in all international work in this field, within the framework of the EU as well as of the OECD and of the Nordic Council of Ministers, etc. Therefore, a very broad experience is available when it comes to assessing documentation delivered by applicants concerning genetically modified foods. The experience covers plants as well as microorganisms. 5. In order to inform the Danish public of the issue of genetically modified foods the Danish Veterinary and Food Administration has issued several publications and folders and frequently publish articles on the issue in the Administration’s magazine. The issue is also taken up by other fora and has over the years been the topic of many conferences and meetings in general. On this background it is not surprising that it seems to be widely acknowledged that the Danish consumers are well informed of this kind of food. However, contrary to the predictions of some of the actors on the scene, the prevailing scepticism on the part of the consumers in this country does not seem to diminish with growing knowledge of the subject, at least not for the time being. CX/FBT 00/4 Part II page 8 HUNGARY 1. The Ministry of Agriculture and Regional Development being responsible for the agricultural and food legislation has achieved most of its harmonisation tasks by implementing the legislation of the European Union 90/220/EC and 258/97/EC respectively. 2. One of the most important pieces of legislation if the Act XC of 1995 on Foods and the Joint Decree No. 1-1996. (I.9.) FM-NM-IKM on the Execution of the above Act as amended by Joint Decrees No. 35/1996. (XI.30.) FM-NM-IKIM and 45/1999. (IV.30) FVM-EüM-GM in consolidated structure. The above-mentioned act is in force from the 1st of January 1996 which determines the conditions of the production and marketing of raw, semi-processed and processed food intended for public consumption in such a way that the protection of consumer health and interests and fairness of market competition are ensured and the free circulation of these goods between countries is promoted. 3. Article 6 (3) states, that the production of novel food shall be licensed by the Minister of Agriculture in agreement with the Minister of Public Welfare. Article 14 (4) of the Decree states that for the purpose of obligation of licensing, foods produced in whole or part from genetically modified ingredients shall not be regarded as novel foods if the percentage of the ingredient resulting from genetic modification is not more than 2 %, or neither DNA nor protein resulting from genetic modification is present. (The 2 % threshold has been declared according to the preliminary plans of the Commission nevertheless according to the latest modifications our legislation will be amended as well.) Furthermore another Act has been accepted by the Hungarian Parliament regarding the biotechnological activities including the approval procedure of the GMOs. SINGAPORE Singapore's experience 1. The Genetic Modification Advisory Committee (GMAC) was established in Singapore in April 1999 to ensure public safety, while allowing for the commercial use of genetically modified organisms (GMOs) and GMO-derived products by companies and research institutions in Singapore. Four subcommittees were formed by GMAC to deal with the wide range of issues related to GMOs which include: • Biosafety Guidelines for Agriculture-Related GMOs • Biosafety Guidelines for Research on GMOs • Labelling of GMO or GMO-derived products • Public awareness programme on GMOs 2. The Sub-Committee on Biosafety Guidelines for Agricultural Products, has come up Singapore Guidelines on the Release of Agriculture-Related GMOs which have been approved by GMAC. The Guidelines cover genetically modified animals, plants, fish, insects, microorganisms and vaccines used in cultivation and farming, as well as primary food such as meat, eggs, fish, vegetables and fruits. 3. The objective of the Guidelines is to ensure the safe import, release and use of agriculturerelated GMOs in Singapore. The Guidelines provide a common framework for (i) the assessment of risks for agriculture-related GMOs to human health and the environment and (ii) the approval mechanisms for the release of agriculture-related GMOs in Singapore. In addition, the Guidelines CX/FBT 00/4 Part II page 9 address issues related to food safety based on the concept of substantial equivalence. Tools for risk assessment have also been included in the Guidelines. A science-based approach was used in the drafting of the Guidelines. 4. Applications for the release and use of GMOs and GMO-derived products will be submitted to GMAC which will refer them to the Sub-Committee for consideration. The Sub-Committee will evaluate the application in accordance to the Guidelines to ensure the safety to human health and the environment. 5. The Sub-Committee will then make recommendations to GMAC to endorse the approval for the release of the relevant agriculture-related GMOs if it is found to be safe. It will also monitor the control of the release and use of these products through the relevant regulatory agencies. The relevant agencies i.e. the Primary Production Department1 , Ministry of the Environment, Ministry of Health and National Parks Board have been designated to implement the Guidelines using their existing legislations. These agencies will adhere to the Guidelines when they approve the release and use of agriculture related GMOs and GMO-derived products. ASEAN Experience 6. The ASEAN Ministers on Agriculture and Forestry (AMAF) endorsed the ASEAN Guidelines on Risk Assessment of Agriculture-Related GMOs at their 21st Meeting in October 1999. 7. The Guidelines are aimed at providing ASEAN member countries with a common understanding and approach to undertake scientific evaluations of applications for the release of agriculture-related GMOs in their countries. They describe the procedures for notification, approval and registration of agriculture-related GMOs. Information on approval of agriculture-related GMOs would be deposited at the ASEAN Secretariat. This will provide a database and will assist member countries to evaluate similar applications more easily. 8. The Guidelines also address the need for each country to establish its own National Authority on Genetic Manipulation(NAGM) and the roles and responsibilities of this authority in regulating agricultural GMOs. 9. Additionally, AMAF agreed that there was a need to improve public understanding and awareness on GMOs. The Guidelines would serve as a scientific basis to evaluate GMOs and to begin this educational process. In addition, ASEAN will work towards establishing a risk communication programme on GMOs. The ASEAN Secretariat will coordinate this programme. 1 The government agency in Singapore overseeing primary food, agriculture and veterinary matters. SOUTH AFRICA Legislation: 1. South Africa has various laws that complement each other. The Genetically Modified Organisms Act. 1997 (Act 15 of 1997)addresses importation, contained use, trial release and general release of genetically modified organisms. This Act is administered by the National Development of Agriculture. The Foodstuffs, Cosmetics and Disinfectants Act, (Act 54 of 1972) which is a reactive Act, addresses food safety and provides for labelling of foods and this Act is administered by the Department of Health. CX/FBT 00/4 Part II page 10 Status of request for commercial release 2. One genetically modified corn modification and one cottonseed modification have been licenced in South Africa under the Pest Control Act 1993(Act 36 of 1993). Some genetically modified food commodities have been submitted for regulatory approval and are now considered in terms of the GMO Act. Regional Experience 3. Individual scientists involved in assessment of GMOs have participated in workshops and lectures in the Southern and Eastern Regions of Africa. National Experience 4. The Development of Health established a legislatory advisary group on GMF labelling in cooperation with the National Development of Agriculture. The purpose is the development of labelling requirements. UNITED STATES OF AMERICA The United States believes that consideration of experience gained by countries in conducting food safety and nutritional assessments will aid the work of the Task Force. This Section will be further developed and provided through a supplemental response to this CL.