1. THE IMPACT OF AGRICULTURAL BIOTECHNOLOGY ON ENVIRONMENTAL AND FOOD SECURITY RISK ANALYSIS AND BIOSAFETY OF GMOS Dr. Moisés Burachik Secretariat of Agriculture, Livestock, Fisheries and Food

2. SUMMARY  BIOTECHNOLOGY IMPACTS  BIOSAFETY  RISK ANALISIS OF GMOs  RISK ASSESSMENT: DATA REQUIREMENTS FOR REVIEW: - PHENOTYPIC EXPRESSION - MOLECULAR GENETICS  RISK MANAGEMENT  RISK COMMUNICATION  IMPLEMENTATION OF THE REGULATORY FRAMEWORK

3. BIOTECHNOLOGY IMPACTS

4. SOME BIOTECHNOLOGY IMPACTS ON AGRICULTURE  DE RECURSOS CROPS CAN BE MODIFIED TO OBTAIN:  INCREASES IN PRODUCTIVITY AND QUALITY OF PRODUCTS  SIMPLIFIED AND IMPROVED AGRICULTURAL PRACTICES  MORE EFFICIENT USE OF RESOURCES  RESISTANCE AGAINST INSECTS, PATHOGENS, ABIOTIC STRESSES  INCREASES IN LAND AVAILABLE TO AGRICULTURE

6. SPECIAL QUESTIONS RELATED TO GMOS DERIVED FOOD DEVELOPMENT OF REVIEW PROCEDURES AND METHODS FOR FOODSAFETY ASSESSMENT IMPACTS (INCREASES?) IN NUTRITIONAL VALUE NEW USES (MOLECULAR PHARMING, PLASTICS) QUALITY IMPROVEMENT IMPROVED PROCESSING TECHNOLOGIES THERAPEUTIC USES (VACCINES, DRUGS)

8. AGRICULTURAL BIOTECHNOLOGY ALSO IMPACTS ON THE ENVIRONMENT  BIODIVERSITY PROTECTION  SOCIAL ACCEPTANCE  SUSTAINABILITY  REQUIREMENT OF AN APPROPRIATE REGULATORY FRAMEWORK  HARMONIZATION AND COMPLIANCE WITH INTERNATIONAL AGREEMENTS

10. AGRICULTURAL BIOTECHNOLOGY HAS IMPACTS ON OTHER OTHER AREAS  HIGH SCIENCE AND TECHNOLOGY CAPACITIES, COSTOS (NEED FOR AUTONOMOUS DEVELOPMENTS)  HIGH CONCENTRATION OF OWNERSHIP - ROYALTIES (INTELLECTUAL PROPERTY RIGHTS)  MARKET SHIFTS (NEW PRODUCERS, DIFFERENT REGULATORY REQUIREMENTS)

11. BIOSAFETY

12. BIOSAFETY: ONE DEFINITION CONDITION PROVIDED THROUGH A SET OF MEASURES WITH THE PURPOSE OF THE PROTECTION OF HUMAN, ANIMAL, PLANT AND ENVIRONMENTAL HEALTH, AGAINST KNOWN OR PERCEIVED RISKS OF ANY ACTION, PROJECT OR TECHNIQUE, ACCORDING TO THE BEST OF OUR CURRENT SCIENTIFIC KNOWLEDGE.

13. BIOSAFETY REQUIRES THE HARMONIZATION OF DIFFERENT INTERESTS SOCIETY (DEMANDING PROTECTION) GOVERNMENT (IN CHARGE OF THE DESIGN AND IMPLEMENTATION OF THE REGULATORY INSTRUMENTS) THE DEVELOPERS OF THE INNOVATIONS (INVEST IN R & D OF NEW PRODUCTS IN THE MARKET AND EXPECT A RETURN IN ORDER TO KEEP THE PROCESS OF PRODUCING FURTHER INNOVATIONS)

14. BIOSAFETY REQUIRES A COMPLEX AND DYNAMIC REGULATORY FRAMEWORK PROACTIVE (A PROVISIONAL DEFINITION OF THE PRECAUTIONATY APPROACH): –THE REGULATORY FRAMEWORK FOLLOWS ALL ALONG THE DEVELOPMENT OF THE PRODUCT –ANY UNEXPECTED EFFECT IS DETECTED EARLY IN THE DEVELOPMENT AND WILL STOP IT IF ADVISABLE –REASONABLE DOUBTS (COMPLETE SCIENTIFIC DATA ARE NOT NEEDED BUT GAPS SHOULD BE DEFINED ) WILL TRIGGER THE PRECAUTION)

15. A REGULATORY FRAMEWORK REQUIRES ALSO... TRANSPARENT AND SCIENTIFICALLY BASED REVIEWING AND DECISION MAKING PROCESSES APPROPRIATE MEANS TO ALLOW THE PARTICIPATION OF ALL STAKEHOLDERS THROUGHOUT SOCIETY

16. HOW ARE GMOS REGULATED? THE PRODUCT RATHER THE TECHNIQUE IS REGULATED (THE GENETIC ENGINEERING METHODS ARE NOT THE OBJECT OF THE REGULATION) –NOTE: THE PRODUCT (THE GMO WITH THE INSERTED DNA) MAY INCLUDE IN THE GENETIC CONSTRUCT SOME ELEMENTS DERIVED FROM THE PROCESS. IN THIS CASE THEY HAVE TO BE CONSIDERED

17. SOME BIOSAFETY CRITERIA CAN BE GENERAL REVIEWS SHOULD BE DONE: –ON A CASE BY CASE BASIS: GENERIC CRITERIA (ANALOGIES WITH SIMILAR EVENTS OR PLANTS ARE NOT CONVENIENT) –ALLOWING FOR A STEP BY STEP INCREASE IN AGROECOSYSTEM AREA –ON A INDEPENDENT WAY (AGROECOSYSTEMS ARE DIFFERENT IN DIFFERENT COUNTRIES)

18. WHAT ELEMENTS ARE CONSIDERED IN THE DECISION MAKING PROCESS?  THE RESULTS OF THE RISK ANALYSIS REVIEW AND ACTIONS:  ASSESSMENT  MANAGEMENT  COMMUNICATION  THE REGULATORY FRAMEWORK  NATIONAL PRIORITIES  THE COUNTRY’S DEVELOPMENT STRATEGIES (LONG TERM DEVELOPMENT AREAS)  PUBLIC POLICIES

19. HOWEVER, THE DECISION MAKING PROCESS IS NOT SO SIMPLE: OTHER FACTORS ARE ALSO CONSIDERED  IMPACTS ON INTERNATIONAL TRADE (WILL WE BE ABLE TO REACH NEW MARKETS? WILL APROVAL OF A PARTICULAR GMO AFFECT THE ACCEPTANCE BY IMPORTERS? ARE THERE NEW COMPETITORS TO REPLACE OUR SHARE?  SOCIO - ECONOMIC IMPACTS : WILL THE LEVEL OF ADOPTION AFFECT THE BIIOLOGICAL DIVERSITY WHICH WE WISH TO PRESERVE? WILL THE NEW VARIETIES ACCESIBLES FOR SMALL FARMERS?

20. DECISION MAKING MUST ALSO CONSIDER PUBLIC PERCEPTION (NOT A TECHNICAL ISSUE)  WILL CONSUMERS ACCEPT GMO-DERIVED FOOD? THIS IS NOT A SIMPLE QUESTION. IT DEPENDS ON: - THE LEVEL AND QUALITY OF CONSUMERS INFORMATION - THEIR ATTITUDE TOWARDS NEW TECHNOLOGIES AFFECTING TRADITIONAL FOODS - CULTURAL FACTORS, ETC.

21. DECISION MAKING STILL DEPENDS OF SOME ADDITIONAL FACTORS  SCIENTIFIC CAPACITY: RISK ANALYSIS IS A SCIENTIFIC BASED PROCESS.  INTERNATIONAL TREATIES: GMO TRADE IS REGULATED BY INTERNATIONAL AGREEMENTS, CONVENTIONS AND CODES OF CONDUCT, WHICH HAVE IMPACT ON TRADE (CARTAGENA PROTOCOL, BDC, SPS, IPPC, OMC)

22. ARGENTINA REGULATORY FRAMEWORK  THREE STEPS PROCESS 1. Environmental Risk Assessment CONABIA 2. Food Safety Assessment SENASA (Food safety Agency) 3. Impact on international trade DNMA (Agrifood Markets)

23. 1. ENVIRONMENTAL RISK ASSESSMENT TWO PHASES: 1.1. FIRST PHASE. GREENHOUSE AND FIELD TRIAL RELEASE TESTS (APPLICATION WITH 150 QUESTIONS)

24. 1.2. SECOND PHASE. SUBMISSION OF COMPREHENSIVE DOSSIER (WITH ALL SUPPORTING DATA) WITH RESULTS AND STUDIES, ALLOWS GRANTING RELEASE PERMITS WITH LESS INFORMATION REQUIREMENTS, FOR LARGE PLANTINGS (E.G., SEED INCREASE, EXPORTS). NOT A COMMERCIALIZATION PERMIT

26. EXPRESSION OF THE NEW PHENOTYPE CONSISTS IN THE COMPARISON OF THE GMO WITH THE CLOSEST NON-GMO COUNTERPART IT SHOULD CONFIRM THAT: THE GMO ONLY EXPRESSES THE CHANGES INTENTIONALLY INTRODUCED THROUGH THE GENETIC MODIFICATION THE RISKS ASSOCIATED TO THE MODIFICATION ARE ACCEPTABLE AND/OR MANAGEABLE

27. SOME SELECTED FEATURES OF THE GMO ARE SPECIALLY RELEVANT BIOLOGY OF REPRODUCTION AND SURVIVAL TRAITS AFFECTING ADAPTATION TO DIVERSE STRESSES PROXIMATE COMPOSITION LEVELS OF NATURAL TOXICS, ALLERGENS AND ANTINUTRITIONAL FACTORS

28. CHARACTERISTICS RELATED TO THE AGRICULTURAL PRACTICES OF THE NEW CROP THE GROWING AREAS: ARE THEY THE SAME AS TODAY OR THE MODIFICATION WILL ALLOW THE EXPANSION TO NEW AREAS? ANY CHANGES IN AGRICULTURAL PRACTICES? CROP ROTATION WILL BE AFFECTED? HOW VOLUNTARY PLANTS WILL BE CONTROLLED? HOW RESISTANCE MANAGEMENT (INSECTS, WEEDS) SHOULD BE IMPLEMENTED?

29. A CRUCIAL POINT: POTENTIAL INTERACTIONS WITH OTHER PLANTS ARE INTERACTIONS WITH OTHER ORGANISMOS TO BE EXPECTED? IN THE GROWING AREAS, ARE THERE PLANTS WITH WHICH THE GM PLANT IS ABLE TO CROSS? IS OUTCROSSING POSSIBLE? ARE INTERACTIONS WITH WILD RELATIVES TO BE EXPECTED

30. WILD RELATIVES COULD PRESENT SPECIAL PROBLEMS THEY MAY HAVE WEED CHARACTERISTICS IN AGROECOSYSTEMS THEY MAY BE INVASIVE TO UNDISTURBED, “NATURAL” ECOSYSTEMS UNINTENDED (AND UNDESIRABLE) GENE FLOW MAY OCCUR THE REPRODUCTIVE ABILITY OF THE WILD RELATIVE MAY BE INCREASED THE WILD RELATIVE MAY ACQUIRE A SELECTIVE ADVANTAGE (DUE TO A SELECTION (PRESSURE)

31. POTENTIAL UNINTENDED EFFECTS ON OTHER ORGANISMOS SHOULD BE CONSIDERED SOME UNDESIRED EFFECTS: - THE EXPRESSION OF A TOXIN OR OTHER PRODUCT WHICH MAY POTENTIALLY AFFECT THE METABOLISM, GROW, DEVELOPMENT OR REPRODUCTION OF ANIMALS, PLANTS OR MICROORGANISMS - EFFECS ON NON-TARGET ORGANISMS (BENEFICIAL, PREDATORS, POLINIZERS, BIOLOGICAL CONTROL ORGANISMS, PARASITES, SYMBIONTS, MYCORHIZAE)

32. POTENTIAL UNINTENDED EFFECTS OF THE CROP ON HUMAN HEALTH - PHYSICAL CONTACT (FARMERS) - FURTIVE CONSUMPTION - ARE THERE NEW TOXINS, ALLERGENS OR IRRITANTS TO WHICH THE FARMERS MAY BE EXPOSED?

33. THE RESULTS OF PHENOTYPIC EXPRESSION ANALYSIS WILL INDICATE POTENTIAL IMPACTS WHICH ARE TO BE EXPECTED FROM THE GMO RELEASE RESULTS MAY BE: - NON SIGNIFICANT - ACCEPTABLE, CONTROLLABLE - NON ACCEPTABLE THEY WIL BE THE BASIS FOR THE DECISSION MAKING PROCESS

34. MOLECULAR GENETICS CHARACTERIZATION

35. DATA REQUIREMENTS ARE COMPREHENSIVE AND COMPLEX THE TRANSFORMATION SYSTEM: - THE METHOD - THE GENETIC MATERIAL POTENTIALLY INTRODUCED INTO THE PLANT GENOME THE VECTOR: - DONORS (HISTORY OF USE, POTENTIAL TO DO HARM) - GENETIC ELEMENTS (CODING AND NON CODING) - MAP OF RESTRICTION SITES - SEQUENCES USED AS PROBES AND/OR PCR PRIMERS

36. THE BIOLOGICAL PROPERTIES OF THE NOVEL EXPRESSED PROTEIN IT MUST BE DEMOSTRATED THAT: IT HAS NO POTENTIAL TO CAUSE DISEASE OR HARM TO PLANTS OR OTHER ORGANISMS IS NOT A: KNOWN TOXIC, ALLERGEN, PATHOGENIC FACTOR, IRRITANT

37. THE STRUCTURAL PROPERTIES OF THE NOVEL EXPRESSED PROTEIN –INSERTED SEQUENCES (FULL, TRUNCATED) –NUCLEOTIDE CHANGES RESULTING IN AMINOACID SEQUENCE MODIFICATIONS –IF SO, EFFECTS OF THESE MODIFICATIONS ON: - POST-TRANSLATIONAL PROCESSING - DOMAINS WHICH ARE CRUCIAL FOR STRUCTURE OR FUNCTION

38. THE PROTEIN IN THE PLANT - FUNCTION - EXPRESSION IN THE TISSUES, CONSISTENT WITH THEIR CONTROLLING REGULATORY SEQUENCES - EXPRESSION LEVELS (PROTEIN OR RELEVANT mRNA)

39. SPECIAL CASES - FRAGMENTS OF GENETIC CONSTRUCTS NOT EXPECTED TO BE FUNCTIONAL IN THE PLANT - FULL OR TRUNCATED SEQUENCES OF A SELECTION MARKER UNDER A BACTERIAL PROMOTER CONTROL

40. WHAT SHOULD BE KNOWN ABOUT THE INSERTED DNA ITS STABILITY, HOW IT IS INHERITED, IF IT MAY BE MOBILIZED IF FULL OR TRUNCATED COPIES HAVE BEEN INSERTED, AND THEIR NUMBER IF NUCLEOTIDE SEQUENCES HAVE BEEN MODIFIED (OR NOT) TO AVOID TRANSLATION OF THEIR MESSENGERS IF THEY CONTAIN ANTISENSE CONSTRUCTS

41. OTHER DATA NEEDED ON THE INSERTED DNA POSITION AND INTEGRITY OF FUNCTIONAL PROMOTERS PROMOTORS AND OTHER REGULATORY REGIONS WHICH COULD BE EXPRESSED IN BACTERIA DETAILED ANALYSIS OF THE INSERT AND ITS FLANKING REGIONS IN THE PLANT GENOME SEQUENCES OF PUTATIVE PEPTIDES EXPRESSED BY READ-THROUGH AND/OR GENERATION OF OPEN READING FRAMES

42. RISK MANAGEMENT

43. CROP CONTAINMENT PRACTICES: –PHYSICAL (CAGES, SLOPE, FLOWERES BAGGING) –SPACIAL (ISOLATION DISTANCES) –PHENOLOGIAL (DIFFERENT FLOWERING TIMES) –NON-GMO BUFFER ZONES –CONTROL OF EMERGENCY OF VOLUNTARY PLANTS THE NEXT SEASON(S)

44. OTHER RISK MANAGEMENT PRACTICES RESTRICTIONS TO FURTHER USE OF THE FIELD HYBRID PRODUCTION (PARENTAL TYPE OF THE POLLEN PRODUCER) SPECIALES PROTOCOLS (GEN FLOW CONCERN) SCALE OF RELEASE (AMOUNT OF POLLEN EMISSION) INSPECTIONS SPECIFIC MONITORING (SPECIAL REQUIREMENTS)

45. RISK COMMUNICATION

46. HOW TO COMMUNICATE THE RISKS? HOW THE INFORMATION IS TO BE RELEASED TYPE LEVEL DIFUSSION MEDIA CONFIDENTIAL INFORMATION? QUALIFIED OBJECTIONS EFFECTS ON DECISSION MAKING?

47. OTHER ISSUES CONCERNING COMMUNICAT ION EDUCATION PROGRAMS TARGET AUDIENCES LEVEL MEDIA STRATEGIES PUBLIC PERCEPTION PROGRAMS

48. IMPLEMENTATION OF THE REGULATORY FRAMEWORK

49. WHAT IS NEEDED? MECHANISMS FOR THE ASSESSMENT, MANAGEMENT, COMMUNICATION AND MITIGATION OF RISKS APPROPRIATE BUDGET, INFRASTRUCTURE COMPLIANCE VERIFICATION MECHANISMS TRANSPARENCY IN DECISION MAKING

50. IMPLEMENTATION OF A REGULATORY FRAMEWORK MUST ALSO CONSIDER OTHER OBLIGATIONS INTERNATIONAL COOPERATION (BDC, CP, IPPC, WTO) HARMONIZATION (REGIONAL, INTERNATIONAL) MECHANISMS FOR PUBLIC PARTICIPATION

51. THE IMPLEMENTATION OF THE REGULATORY FRAMEWORK DOES NOT END WITH THE RISK ASSESSMENT PROCESS POST- COMMERCIALIZATION MONITORING EXAMPLES: INSECTS AND HERBICIDES RESISTANCE MANAGEMENT LONG TERM EFFECTS

52. THERE ARE ALSO LEGAL AND TECHNICAL REQUIREMENTS GUIDELINES, WELL DEFINED STRUCTURE OF THE BIOSAFETY SYSTEM RELIABLE PROFESSIONALS

53. HOW TO CONDUCT THE ASSESSMENTS? THE PROCESS SHOULD BE BASED IN THE BEST AND CURRENT SCINTIFIC INFORMATION MECHANISM SHOULD BE IMPLEMENTED FOR THE AWARENESS AND USE OF NEW INFORMATION WHEN NEEDED