International Issues on GM Foods The future challenges and missions for Codex Biotech Task Force in the next four years 21 September 2005 Background 2

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1 International Issues on GM Foods The future challenges and missions for Codex Biotech Task Force in the next four years 21 September 2005 Background 2003, 26 th Codex Alimentarius Commission considered proposal to establish a new Task Force requested Japan to lead to prepare a project document: draft terms of reference list of potential areas of work

2 Background 2004, 27 th Codex Alimentarius Commission agreed to establish a new Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology adopt the Terms of Reference Delegate Japan to host Final report to Commission in 2009 Objectives To develop standards, guidelines or recommendations on the basis of scientific evidence, risk analysis and having regard to other factors relevant to the health of consumers and the promotion of fair practices in the food trade.

3 Time of frame Task Force shall complete its work within four years ( ). Task Force shall submit a full report in Terms of Reference To elaborate standards, guidelines, or other principles, taking account of the Principles for the Risk Analysis To coordinate and closely collaborate, with appropriate Codex Committees To take account of existing work carried out by national authorities, FAO, WHO, other international organizations

4 Principles for the Risk Analysis CAC/GL Principles Risk Assessment Risk Management Risk Communication Consistency Capacity Building and Information Exchange Review Processes Potential Areas of Work Foods derived from Animals transgenic animals, including fish cloned animals Foods derived from plants Plants expressing bioactive substances or nutritionally-enhanced plants Plants with stacked genes (i.e. several genes conferring different traits in the same plant) Biopharming Plants expressing pharmaceutical or other non-food substance Low level presence of unauthorized GM foods in authorized foods Comparative food composition analysis Reference: CL 2005/2-FBT

5 Potential Areas of Work: - Country proposals JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX AD HOC INTERGOVERNMENTAL TASK FORCE ON FOODS DERIVED FROM BIOTECHNOLOGY Fifth Session Chiba, Japan, September 2005 European Community (EC) EC proposes in a decreasing priority order: 1. Low level presence of unauthorized GM material in food 2. Food safety assessment of GM animals (including fish) 3. GM plants expressing pharmaceutical or non-food substances ( bioactive substances ) 4. Food safety assessment of food derived from multiple recombinant-dna plants (stacked genes) 5. Food safety issues specific to staple food crops for developing countries (food composition) 6. Food produced from clone animals and their offspring Reference: CX/FBT 05/5/4-Add.1 (June 2005)

6 EC on Stacked Gene Plants The Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL ) does not address the case. More and more stacked gene plants are on the market and under development Needs a guidance as to identify specific food safety issues and how to assess and manage these issues Reference: CX/FBT 05/5/4-Add.1 (June 2005) EC on Stacked Gene Plants Relevance to Codex Strategic Objectives Promotion of consumer protection Promotion of the application of scientific principles and risk analysis Facilitation of trade of food Reference: CX/FBT 05/5/4-Add.1 (June 2005)

7 Japan Suggests 3 items in priority: 1. Foods derived from plants with stacked genes 2. Foods derived from nutritionallyenhanced plants 3. If GM animals to be discussed, priority should to given to GM fish Stacks in Japan As of 5 Sept 2005 MHLW ( 働 ) approved: Corn 1. MON863 x NK GA21 x MON T25 x MON TC1507 x NK MON810 x MON Mon863 x MON810 x NK603 Cotton x x MON88913 x MHLW under Evaluation Corn MON88017 x MON810 Alfalfa J101 x J163 Cotton 281 x 3006 Source:

8 United States US proposes: 1. Food Safety Issues Specific to staple food crops for developing countries (Food composition) 2. Low-level presence in food of plant material derived from recombinant-dna plants Reference: CX/FBT 0/5/4 (May 2005) United States US says No to: 1. Transgenic animals 2. Cloned animals 3. Plants expressing bioactive substances or nutritionally-enhanced plants 4. Plants with stacked genes 5. Biopharming/plants expressing pharmaceutical or other non-food substances

9 Australia High Priority work Foods derived from transgenic animals Foods derived from cloned animals Comparative food composition Plants expressing bioactive substances or nutritionally enhanced plants Low Priority Work Plants with stacked genes Low level presence of unauthorised GE foods in authorised foods Work outside the scope of the Task Force Biopharming Plants expressing pharmaceutical or other non-food substances Biotechnology Industry Organization Guidelines/Principles for the assessment of the inadvertent, intermittent low-level presence of proteins(s) in food/food ingredients for Approved/authorized within a country/countries that follow Codex risk assessment Unapproved/unauthorized traits

10 Issues Related to Taiwan Codex Issues = Taiwan s GMF problems Taiwan: Transgenic & Cloned Animals ( )

11 Taiwan: Biopharming Tg gilt No. 8-3 Tg gilt No. 8-5 Tg pigs harboring both transgenes of LA- plf &LA- hfix genes 59 Taiwan: Bioactive substances Field Trials in progress at TARI in 2003~ GM Plants rice rice rice rice potato broccoli Transgene Phytase gene Phytase gene Amylopullulanase gene Lactoferrin gene Phytase gene IPT (isopentenyl transferase) Applicants Academia Sinica InGene Academia Sinica Nat l Chung Hsing Univ Academia Sinica Academia Sinica TARI: Taiwan Agricultural Research Institute

12 Taiwan: Stacks ( ) Problems faced Registration Risk assessment Detection Methods Threshold to labeling (stacked traits hybrid)? Transformation Event A Transformation Event B Back-crossing Back-crossing Selfing Selfing Inbred I (Event A) X Inbred II (Event B) Hybrid I-A x II-B

13 Taiwan: stacks at DOH( ) Corn MON810 x T25 MON810 x GA21 ( ) MON810 x NK603 ( ) MON810 x MON863 ( ) MON863 x NK603 ( ) MON810 x MON863 x NK603 ( ) TC1507 x NK603 Alfalfa J101 x J163 Taiwan: Low level of unauthorized GMF DKB DBT418 DKB-8979Ø-5 DLL25 -- Bt CBH (StarLink) Other unknown? (GM papaya, GM rice ) * Modified according to DOH publication June 3, 2004

14 Taiwan: Food Composition DOH Guidance of GM Food Safety Assessment (, 2001) to be updated To identify key component, e.g. nutrients, anti-nutrients and toxins. Adoption of OECD Consensus Documents*? e.g.: Consensus Document on Compositional Considerations for New Varieties of Maize (Zea Mays): key food and feed nutrients, anti-nutrients and secondary plants metabolites. * Convention on Biological Diversity Terms of Reference To take account of existing work carried out by national authorities, FAO, WHO, other international organizations Risk Assessment & Risk Management Ad Hoc Technical Expert Group on Risk Assessment under the Cartagena Protocol on Biosafety Italy, November 2005 Reference: UNEP/CBD/BS/COP-MOP/2/INF/2 (country positions) UNEP/CBD/BS/COP-MOP/2/9 (excellent overview)

CONCLUSIONS Capacity Building Infra-structure for safety assessment New Guidelines for safety management Implementation of Codex Risk Analysis New Issues Reference: McLean, et al.

15 CONCLUSIONS Capacity Building Infra-structure for safety assessment New Guidelines for safety management Implementation of Codex Risk Analysis New Issues Reference: McLean, et al. A conceptual framework for implementing biosafety: Linking policy, capacity & regulation. ISNAR Briefing paper No.47, International Issues on GM Foods The future challenges and missions for Codex Biotech Task Force in the next four years THANK YOU Wen-Yen Kao, Ph.D. wenyen.kao@syngenta.com

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