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									  Genetically Modified Organisms:
      Regulatory Framework
            In Argentina.
            An Overview
Ministerial Conference on Use of Science and Technology
For Improving Competitiveness in the Agricultural Sector
                    IICA, Costa Rica
             May 10-11, SanJosé de Costa Rica

                                   Dr Moisés Burachik
                                                        1
 Three steps system (SAGPyA)


• ENVIRONMENTAL RISK ASSESSMENT
     (CONABIA)


• FOOD SAFETY
     (CTA, SENASA)


• IMPACT ON INTERNATIONAL TRADE
     (DNMA)
                                  2
   SAGPYA: SECRETARY OF AGRICULTURE, LIVESTOCK,
                  FISHERIES AND FOOD

   CONABIA: NATIONAL ADVISORY COMMISSION ON
                  AGRICULTURAL BIOTECHNOLOGY

   CTA: TECHNICAL ADVISORY COMMISSION ON USE OF
                  FOOD DERIVED FROM GMOS

   SENASA: NATIONAL SERVICE FOR AGRI-FOOD SAFETY
                  AND QUALITY

   DNMA: NATIONAL DIRECTORATE OF AGRI-FOOD
                 MARKETS
                                                3
        BIOTECHNOLOGY OFFICE
             (WITHIN SAGPYA)



       VISION:


   BIOTECNOLOGY IS CONSIDERED A STRATEGIC
            TECHNOLOGY


   IT HAS THE POTENTIAL TO IMPROVE THE
             WELFARE OF ARGENTINE SOCIETY
             THROUGH SEVERAL WAYS:

                                             4
           BIOTECHNOLOGY OFFICE
               (WITHIN SAGPYA)
    MISSION
          INCREASING FOOD SECURITY
          INCREASE NUTRITIONAL STATUS OF
               UNDERNURISHED POPULATIONS
          FAVOUR COMMERCE AND IMPROVE TRADE
              BALANCE
          CREATE NEW ADDED-VALUE PRODUCTS
              ALLOWING TO MOVE AWAY FROM A
              STRONGLY COMMODITY - BASED
              ECONOMY
          CREATE NEW JOB OPPORTUNITIES      5

            BIOTECHNOLOGY OFFICE
                (WITHIN SAGPYA)
    MISSION (Cont.):

           COORDINATE THE SEVERAL SECTORS
               INVOLVED IN AGRICULTURAL
               BIOTECHNOLOGY

           PROMOTE PRODUCTIVE INTERACTIONS
               BETWEEN THESE SECTORS

           AVOID DUPLICATION OF WORK AND MAKE
               BETTER USE OF CAPACITIES

           TAKE ADVANTAGE OF TEAM WORK

                                              6
        BIOTECHNOLOGY OFFICE
           (WITHIN SAGPYA)
THREE DIVISIONS : (ALL INTERACTING)

       BIOSAFETY (CONABIA)


       GUIDELINES AND STANDARD
           OPERATING PROCEDURES


       ANLYSIS AND DESIGN OF
           APPROPRIATE POLICIES
                                      7
Technical Advisory (non decisory)
 Commissions (CONABIA, CTA)


   Decisions taken by the Secretary of SAGPYA

   Membership

    – Public (Government, Academic)

    – Private (Trade Associations, not Companies)



                                                 8
RISK ANALYSIS



• RISK ASSESSMENT

• RISK MANAGEMENT

• RISK COMMUNICATION




                       9
   1. Environmental Risk Assessment
               CONABIA
Two phases:

1.1. FIRST PHASE. GREENHOUSE AND FIELD TRIAL
     RELEASE TESTS (APPLICATION WITH  150
     QUESTIONS).

     ALLOWS EARLY DETECTION OF UNINTENDED
     EFFECTS (PRECAUTIONARY APPROACH)


                                         10
  1. Environmental Risk Assessment
                CONABIA

1.2. SECOND PHASE. COMPREHENSIVE
     DOSSIER (COMPLETE SUPPORTING DATA
     AND RESTRICTED CONFIDENTIAL
     INFORMATION).

     GRANTING OF FURTHER RELEASE PERMITS
     REQUIRE LESS INFORMATION (FOR LARGE
     PLANTINGS, E.G., OFF-SEASON SEED
     PRODUCTION FOR EXPORT, REGULATORY
     STUDIES)

NOT A COMMERCIALIZATION PERMIT
                                         11
           Risk Management

 SPECIFIC RULES ARE ESTABLISHED ON
     ISOLATION DISTANCES AND FURTHER USE
     OF FIELD

 A SYSTEM OF INSPECTIONS IS IN PLACE

 APPLICANTS ARE REQUIRED COMPREHENSIVE
     REPORTS OF TRIALS

 EVALUATIONS ARE STRICTLY TECHNICAL
     (BIOSAFETY, PRECAUTIONARY APPROACH,
     Etc) AND BASED ON THE INFORMATION
     PRESENTED                           12
    2. Food Safety Assessment

• SUBSTANTIAL EQUIVALENCE CONCEPT

• CODEX ALIMENTARIUS + OTHERS

• PROTEIN DATABASE USED (TOXICS AND

    ALLERGENS)

• ANIMAL FEED STUDIES

• TOXICOLOGY ANALYSIS



                                      13
    3. Impact on international trade


• REGULARY SITUATION ( IN IMPORTING

    COUNTRIES)

• MARKET SHARE

• PROSPECTIVE STUDIES

• NEW MARKETS AND/OR COMPETITORS

• PUBLIC PERCEPCION SITUATION

                                       14
4. Main principles:


       – FOCUS ON BIOSAFETY

       – SCIENCE-BASED REVIEW PROCESS

       – CASE-BY-CASE BASIS REVIEW

       – PRECAUTIONARY APPROACH

       – AGRO-ECOSYSTEM CONCEPT

       – SUBSTANTIAL EQUIVALENCE

                                        15
   GENETICALLY MODIFIED CROPS
APPROVED FOR COMMERCIALIZATION IN
           ARGENTINA
   Soybean Glyphosate tolerance      "40-3-2"

   Maize   Lepidopteran resistance "176"

   Maize Ammonium glufosinate tolerance “ T 25"

   Maize   Lepidopteran resistance   "MON 810”

   Cotton Lepidopteran resistance    "MON 531"

   Cotton Glyphosate tolerance       "MON 1445"

   Maize   Lepidopteran resistance   "Bt 11"
                                                  16
         BIOTECHNOLOGY OFFICE
             (Other activities)


   INTERACTION WITH SIMILAR FOREIGN BODIES

   ANALYSIS OF OTHER CURRENT REGULATORY
       FRAMEWORKS

   WORKSHOPS, INFORMATION EXCHANGE

   INSTITUTIONAL ADVICE IN THE REGION

   ENVIRONMENTAL RISK ASSESSMENTS COURSES

                                              17
    HARMONIZATION INITIATIVES


   PARTICIPATION IN THE US/CANADA
       BILATERAL ON PHENOTYPIC EXPRESSION
       AND MOLECULAR GENETICS
       CHARACTERIZATION

   DATA AND ENVIRONMENTAL RISK
       ASSESSMENT CRITERIA

   ASSESSMENT ASSISTANCE AT REGIONAL
       LEVEL, WORKSHOPS
                                        18
            NATIONAL POLICY


   REGULATORY LEGISLATION (LAW)

   CONVENTION ON BIOLOGICAL DIVERSITY

   CARTAGENA PROTOCOL

   PREPARATION OF POSITION DOCUMENTS AT
    INTERNACIONAL FORA (FAO, CODEX, ISO, IPPC)

   TECHNICAL SUPPORT TO NEGOTIATIONS

   RESPONSE TO PUBLIC INQUIRIES
                                             19
           NATIONAL CONTEXT

 Low % of GNP applied to S&T budget (0,25 %, with
      almost no contribution from the private
      sector)

 Increasing (still low) University-Industry linkage

 High level of scientific expertise

 Strong emphasis in basic research, less interest
      in real life applications (now slowly changing)

 Low exposure of regulatory agencies
                                                 20
    INTERNATIONAL CONTEXT

 EU “SUSPENSION” OF APPROVALS
    (MORATORIUM?)

 NEGATIVE LABELING REQUIREMENTS

 ONGs ACTIVITIES AGAINST GMOs

 NEGATIVE ENVIRONMENT AT INTERNATIONAL
    FORA (E.G., SPS INCLUDING ANALYSIS OF
    GMOs AS PESTS, BIOSECURITY =
    BIOSAFETY)
                                     21
    INTERNATIONAL CONTEXT

 REQUIREMENTS FOR IDENTITY
    PRESERVATION (ONLY LABELING?)
 SEGREGATION AT THE COMMODITY LEVEL
     (COST OF IMPLEMENTATION, FOR
     DEVELOPING COUNTRIES) (ONLY
     LABELING?)

 INTELLECTUAL PROPERTY PROBLEMS (MAIN
     PROBLEM?)
 PRIVATIZED RESEARCH (LESS ACADEMIC
    COMMUNICATIONS)

                                    22
                       THE RISKS
          PROBLEMS IN THE IDENTIFICATION,
       ASSESSMENT AND MANAGEMENT OF RISKS

   UNCERTAINTIES ASSOCIATED WITH TECHNOLOGY
       INNOVATION
   OBJECTIVE vs SUBJECTIVE JUDGEMENTS
   PUBLIC PERCEPTION – DRIVEN EFFECTS ON THE
       REGULATION
            - SCIENTIFIC vs EMOTIONAL
            - SCIENTIFIC vs COMMERCIAL
   TECHNOLOGY GAPS
   PRESSURE BY INTEREST GRUPS
                                                23
            THE RISKS

- LOSS OF BIODIVERSITY:

- MARKET PRESSURE ON FARMERS: PRODUCTION
  ADVANTAGES  LOSS OF LAND-RACES

- CULTIVATION NEAR CENTERS OF ORIGIN OF
  BIODIVERSITY  GENE FLOW, LOSS OF WILD
  ANCESTORS

– PRODUCTION DE UNDESIRED PHENOTYPES
  THROUGH GENE TRANSFER TO SEXUALLY
  COMPATIBLE SPECIES (OUTCROSSING):

– WILD RELATIVES OF GM PLANT, WEEDS
                                           24
SELECTIVE PRESSURE TOWARDS INCREASED PEST
TOLERANCE TO CURRENTLY USEFUL PESTICIDES:
   BIODEGRADABLE HERBICIDES
   MICROBIAL INSECTICIDES
   BIOLOGICAL CONTROL AGENTS

   MANAGEMENT OF THE ABOVE CHANGES:
      - FARMERS COMPLIANCE
      - MONITORING, WARNING PROCEDURES

                                         25
   CHANGES IN THE PREDATOR-PREY RELATIONSHIPS
   NEGATIVE EFFECTS ON BENEFICIAL INSECTS
   THREAT TO ENDANGERED SPECIES
   LOSS OF REFUGIA / RESERVOIRS
   (HORIZONTAL) GENE TRANSFER PHENOMENA IN
    NATURAL HABITATS?
    – SOIL
    – MAMMALIAN INTESTINE
    – ANTIBIOTICS RESISTANCE GENES TO HUMAN
      PATHOGENS
                                                 26
   LONG TERM CHANGES IN ECOLOGY RELATIONSHIPS

   UNEXPECTED GENETIC RECOMBINATION PHENOMENA
       WITH EFFECTS ON PATHOGENS:
             • EPIDEMIOLOGY
             • ECOLOGY
             • HOST RANGE

   ANTIBIOTICS INACTIVATION PROTEINS ENTERING THE
       FOOD CHAIN?

   NEED TO CHANGE TYPE OF SELECTION MARKERS

   CHANGES IN THE TRANSFORMATION METHODS
       (“CLEAN INSERTS”)
                                                 27
– COMMERCIAL EFFECTS:

  • POSSIBLE CHANGES IN TRADE
        PATTERNS

  • CHANGES IN CROP GEOGRAPHIC AREAS

  • NEW PRODUCERS

  • TRADE BARRIERS

  • TRACEABILITY (Not mentioned in the
    Cartagena Protocol, but needed for
    labeling)                          28
       THE PRESENT DYNAMIC SCENARIO


   CROPS OF ECONOMIC IMPORTANCE HAVING HIGH
       OUTCROSSING POTENTIAL (E.G. SUNFLOWER,
       TOWARDS WILD RELATIVES AND RELATED
       SPECIES, OTHER TROPICAL SPECIES?)
       HOW TO OBTAIN USEFUL GM CROPS FROM
       THESE

   REVIEW ISOLATION DISTANCES

   GENE FLOW TO WILD RELATIVES, COMPATIBLE
       WEEDS                                  29
       THE PRESENT DYNAMIC SCENARIO



   STRENGTHENING CAPACITY FOR FOOD SAFETY

       REVIEW PROCESS (ANIMAL MODELS FOR

       ALLERGENICITY, PROTEIN DATA BASE)



   EFFECTIVE COMMUNICATION STRATEGIES




                                           30
       THE MEDIUM TERM SCENARIO

   EXPANDING CAPACITY BUILDING FOR REVIEW
   EXTENDED USE OF THE BIOSAFETY CLEARING HOUSE
   INCREASED GENETIC CONSTRUCTS COMPLEXITY
   MULTIGENIC TRAITS
   GURT’S
   BASELINE RESISTANCE/TOLERANCE LEVELS (INSECTS,
       WEEDS)
   DEVELOPING OF “LONG TERM” MONITORING
       INDICATORS
   BIOLOGICAL DIVERSITY SURVEYS

                                                   31
         THE MEDIUM TERM SCENARIO


   MORE COUNTRIES ACCEPTING GMOs

   NEW CROPS (TROPICAL?) ENTERING THE MARKET

   COMMODITY TRADE COMPLICATED (cost increases)

   CHANGING INTELLECTUAL PROPERTY RULES

   END OR EASENING OF MORATORIA

   PRIMERS AND PCR PROTOCOLS BANK
       (CONFIDENTIALITY, INTELLECTUAL PROPERTY
       ISSUES, LEGAL MATTERS)
                                                   32
               FINAL COMMENTS


   REGULATORY FRAMEWORK
    – SCIENTIFIC
    – CASE BY CASE
    – PRECAUTIONARY APPROACH
    – CLEAR
    – TRANSPARENT DECISION MAKING PROCESS
    – VISIBILITY TO SOCIETY
    – INFORMATION DATABASE FOR PUBLIC
              CONSULTATION
                                            33
          BUILDING A SYSTEM

   RECRUIT A HIGH QUALITY SCIENTIFIC STAFF
   THE ENVIRONMENT - AGROECOSYSTEM TRAP
   CERTAIN CROPS, ACREAGE SIZE, SITES,
       QUALITY REQUIREMENTS, MAY REQUIRE
       SPECIFIC HANDLING PROTOCOLS
   BE UPDATED ON THE PERTINENT SCIENTIFIC
       MATTERS
   CALL OTHER EXPERTS WHEN NEEDED
                                          34
   DEVELOP A COMMUNICATION STRATEGY

   PROMOTE PROACTIVE PARTICIPATION OF

      ALL STAKEHOLDERS

   DEVELOP PUBLIC PERCEPTION




                                         35

								
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