THE IMPACT OF AGRICULTURAL BIOTECHNOLOGY ON ENVIRONMENTAL

AND FOOD SECURITY

RISK ANALYSIS AND BIOSAFETY OF GMOS

Dr. Moisés BurachikSecretariat 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 RECURSOSCROPS 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)

ARGENTINAREGULATORY 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 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?

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 BEEXPECTED

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 GENETICSCHARACTERIZATION

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 REGULATORYFRAMEWORK 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