Genetically Modified Organisms: Regulatory Framework In Argentina' An Overview

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Genetically Modified Organisms Regulatory
FrameworkIn 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

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Three steps system (SAGPyA)
ENVIRONMENTAL RISK ASSESSMENT (CONABIA)
FOOD SAFETY (CTA, SENASA) IMPACT ON
INTERNATIONAL TRADE (DNMA)
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• 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

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• 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

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• 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

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• 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

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• BIOTECHNOLOGY OFFICE
• (WITHIN SAGPYA)
• THREE DIVISIONS (ALL INTERACTING)
• BIOSAFETY (CONABIA)
• GUIDELINES AND STANDARD OPERATING PROCEDURES
• ANLYSIS AND DESIGN OF APPROPRIATE POLICIES

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Technical Advisory (non decisory)
Commissions (CONABIA, CTA) 

• Decisions taken by the Secretary of SAGPYA
• Membership
• Public (Government, Academic)
• Private (Trade Associations, not Companies)

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RISK ANALYSIS

• RISK ASSESSMENT
• RISK MANAGEMENT
• RISK COMMUNICATION

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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)
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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
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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
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• 2. Food Safety Assessment
• SUBSTANTIAL EQUIVALENCE CONCEPT
• CODEX ALIMENTARIUS OTHERS
• PROTEIN DATABASE USED (TOXICS AND ALLERGENS)
• ANIMAL FEED STUDIES
• TOXICOLOGY ANALYSIS

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• 3. Impact on international trade
• REGULARY SITUATION ( IN IMPORTING COUNTRIES)
• MARKET SHARE
• PROSPECTIVE STUDIES
• NEW MARKETS AND/OR COMPETITORS
• PUBLIC PERCEPCION SITUATION

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4. Main principles

• FOCUS ON BIOSAFETY
• SCIENCE-BASED REVIEW PROCESS
• CASE-BY-CASE BASIS REVIEW
• PRECAUTIONARY APPROACH
• AGRO-ECOSYSTEM CONCEPT
• SUBSTANTIAL EQUIVALENCE 

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GENETICALLY MODIFIED CROPSAPPROVED 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"

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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

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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

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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

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NATIONAL CONTEXT ? Low of GNP applied to ST
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
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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)
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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)
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THE RISKSPROBLEMS 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

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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

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• 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

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• 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

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• 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)

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• 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)

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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

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THE PRESENT DYNAMIC SCENARIO

• STRENGTHENING CAPACITY FOR FOOD SAFETY REVIEW
  PROCESS (ANIMAL MODELS FOR ALLERGENICITY,
  PROTEIN DATA BASE)
• EFFECTIVE COMMUNICATION STRATEGIES

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THE MEDIUM TERM SCENARIO

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

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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)

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FINAL COMMENTS

• REGULATORY FRAMEWORK
• SCIENTIFIC
• CASE BY CASE
• PRECAUTIONARY APPROACH
• CLEAR
• TRANSPARENT DECISION MAKING PROCESS
• VISIBILITY TO SOCIETY
• INFORMATION DATABASE FOR PUBLIC CONSULTATION

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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

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• DEVELOP A COMMUNICATION STRATEGY
• PROMOTE PROACTIVE PARTICIPATION OF ALL
  STAKEHOLDERS
• DEVELOP PUBLIC PERCEPTION