Transcript THE IMPACT OF AGRICULTURAL BIOTECHNOLOGY ON ENVIRONMENTAL AND FOOD SECURITY

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
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
BIOTECHNOLOGY IMPACTS
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
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)
AGRICULTURAL BIOTECHNOLOGY ALSO IMPACTS ON THE
ENVIRONMENT

BIODIVERSITY PROTECTION

SOCIAL ACCEPTANCE

SUSTAINABILITY

REQUIREMENT OF AN APPROPRIATE REGULATORY
FRAMEWORK

HARMONIZATION AND COMPLIANCE WITH
INTERNATIONAL AGREEMENTS
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)
BIOSAFETY
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.
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)
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)
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
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
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)
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
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?
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.
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)
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)
1. ENVIRONMENTAL RISK ASSESSMENT
TWO PHASES:
1.1. FIRST PHASE. GREENHOUSE AND FIELD
TRIAL RELEASE TESTS (APPLICATION
WITH 150 QUESTIONS)
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
RISK ASSESSMENT:
DATA REQUIREMENTS
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
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
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?
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
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)
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)
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?
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
MOLECULAR GENETICS
CHARACTERIZATION
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
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
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
THE PROTEIN IN THE PLANT
- FUNCTION
- EXPRESSION IN THE TISSUES, CONSISTENT WITH
THEIR CONTROLLING REGULATORY SEQUENCES
- EXPRESSION LEVELS (PROTEIN OR RELEVANT mRNA)
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
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
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
RISK MANAGEMENT
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)
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)
RISK COMMUNICATION
HOW TO COMMUNICATE THE RISKS?
• HOW THE INFORMATION IS TO BE RELEASED
TYPE
LEVEL
DIFUSSION MEDIA
CONFIDENTIAL INFORMATION?
• QUALIFIED OBJECTIONS
EFFECTS ON DECISSION MAKING?
OTHER ISSUES CONCERNING COMMUNICAT ION
• EDUCATION PROGRAMS
• TARGET AUDIENCES
• LEVEL
• MEDIA
• STRATEGIES
• PUBLIC PERCEPTION PROGRAMS
IMPLEMENTATION OF THE
REGULATORY FRAMEWORK
WHAT IS NEEDED?
• MECHANISMS FOR THE ASSESSMENT, MANAGEMENT,
COMMUNICATION AND MITIGATION OF RISKS
• APPROPRIATE BUDGET, INFRASTRUCTURE
• COMPLIANCE VERIFICATION MECHANISMS
• TRANSPARENCY IN DECISION MAKING
IMPLEMENTATION OF A REGULATORY FRAMEWORK
MUST ALSO CONSIDER OTHER OBLIGATIONS
•
INTERNATIONAL COOPERATION (BDC, CP, IPPC, WTO)
• HARMONIZATION (REGIONAL, INTERNATIONAL)
• MECHANISMS FOR PUBLIC PARTICIPATION
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
THERE ARE ALSO LEGAL AND TECHNICAL
REQUIREMENTS
• GUIDELINES, WELL DEFINED STRUCTURE OF THE
BIOSAFETY SYSTEM
• RELIABLE PROFESSIONALS
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