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THE IMPACT OF AGRICULTURAL BIOTECHNOLOGY ON ENVIRONMENTAL AND FOOD SECURITY

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THE IMPACT OF AGRICULTURAL BIOTECHNOLOGY ON ENVIRONMENTAL AND FOOD SECURITY RISK ANALYSIS AND BIOSAFETY OF GMOS Dr. Mois s Burachik Secretariat of Agriculture ... – PowerPoint PPT presentation

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Title: THE IMPACT OF AGRICULTURAL BIOTECHNOLOGY ON ENVIRONMENTAL AND FOOD SECURITY


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
5

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

7

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

9

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 COUNTRYS 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
25
(No Transcript)
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 THEAGRICULTURAL
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 REGULATORYFRAMEWORK
DOES NOT END WITH THE RISK ASSESSMENT PROCESS
  • POST- COMMERCIALIZATION MONITORING
  • EXAMPLES
  • INSECTS AND HERBICIDES RESISTANCE MANAGEMEN
    T
  • LONG TERM EFFECTS

52
THERE ARE ALSO LEGAL AND TECHNICALREQUIREMEN
TS
  • 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
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