# Presentation: 201169

## 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**

##    Three steps system  (SAGPyA)

**• ****ENVIRONMENTAL RISK ASSESSMENT**** ****	****	****	****(CONABIA)**
**• ****FOOD SAFETY**** **
**	****(CTA, SENASA)**
**• ****IMPACT ON INTERNATIONAL TRADE**** **
**	****(DNMA)**

##  SAGPYA: SECRETARY OF AGRICULTURE, LIVESTOCK, 			FISHERIES AND FOOD

** ****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**

## BIOTECHNOLOGY OFFICE 

**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:**
**	****	****	****	****	**
**	****	**

## BIOTECHNOLOGY OFFICE 

**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****	**
**	****	**

## BIOTECHNOLOGY OFFICE 

**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****	**
**	****	**

## BIOTECHNOLOGY OFFICE 

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

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

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

## RISK ANALYSIS

**RISK ASSESSMENT**
**RISK MANAGEMENT**
**RISK COMMUNICATION**

## 1. Environmental Risk Assessment

**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)**

## 	NOT A COMMERCIALIZATION PERMIT 

**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**** **

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

**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**

## 		2. Food Safety Assessment	

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

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

## 4.  Main principles: 

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

## 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"****	****	**

## 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**

## 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

**DATA AND ENVIRONMENTAL RISK ****	****	****	****ASSESSMENT CRITERIA**
** ****ASSESSMENT ASSISTANCE AT REGIONAL ****	****	****LEVEL, WORKSHOPS**

**HARMONIZATION INITIATIVES**

## 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**

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

**	** **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**

## 	  EU “SUSPENSION” OF APPROVALS 				(MORATORIUM?)

**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)**
**	**

## 	  REQUIREMENTS FOR IDENTITY 				PRESERVATION (ONLY  LABELING?)

**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)**

## 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 **

## 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**

**	****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**

## 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

**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***

**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”) **

## 
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)

**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)**

## 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**

## THE PRESENT DYNAMIC SCENARIO

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

## 	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**

## 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) **

## FINAL COMMENTS

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

## 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**

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