biotechnology and risk assessment: entransfood...“golden rice” with additional β1carotene is an...

Biotechnology and Risk

Assessment: ENTRANSFOOD

Gijs A. Kleter

SELAMAT conference, August 25, 2004

Schedule

� Introduction

� Safety assessment of GM products

� The ENTRANSFOOD project

� Conclusions

Illustration: CNN

Introduction

The worldwide area of genetically modified (GM)

crops has rapidly increased

0

20

40

60

80

1996 1997 1998 1999 2000 2001 2002 2003

yearm

illi

on

s o

f h

ec

tare

s

USA 63%

Argentina 21%

Canada 6%

Brazil 4%

China 4%

South Africa 1%

Segment 7

Total area, 199612003

Nations, 2003

Data source: C. James, ISAAA , 2003

Introduction

Examples of GM crops are herbicide1resistant

soybean and insect1resistant maize

Soybean

before afterherbicide1application

Maize

Introduction

“Golden rice” with additional β1carotene is an

example of a future biotech crop

Safety assessment of GM products

Illustration: CNN

GM crop

Additional

testing

Safety- and nutritional testing

Evaluation of data

Sufficient Not sufficient

Risk assessment

(New)

proteins

Introduced

genes

(New)

chemical

substances

Comparative safety assessment

� Substantial equivalence

� Toxicity

� Allergenicity

� Gene transfer

� Unintended effects

� Nutritional value

� Pesticide residues


Profiling by LC1NMR

metabolites

GM crop

conventional

crop

extract metabolites

extract

extract

metabolites

generate NMR profiles


Profiling by LC1NMRgenerate NMR profiles

identify differences

trace back to metabolite


Illustration: CNN

The ENTRANSFOOD project

NEW SAFETY

TESTING

DETECTION OF

UNINTENDED

EFFECTS

CONSUMERS

CONFIDENCE

DETECTION,

TRACEABILITY

AND QUALITY

ASSURANCE

TRANSPARENCY

OF PROCEDURES

GENE TRANSFER

IMPROVED

GUIDELINES FOR

TESTING

HARMONISATION OF

RISK ASSESMENT

STRATEGIES

EUROPEAN NETWORK

SAFETY ASSESSMENT OF

GENETICALLY MODIFIED

FOOD CROPS

‘ENTRANSFOOD’

Illustration:

ESA


Participating projects

� SAFOTEST

� Innovative safety testing of GMOs

� GMOCARE

� Detection of unintended effects

� GMOBILITY

� Gene transfer

� QPCRGMOFOOD and GMOCHIPS

� GMO detection and traceability


� Coordination

� Dr. H.A. Kuiper

� Project participation

� 65 participants

� 13 countries

� Total budget

� >10,000,000 Euros

Illustration:

EU


Working Groups

� Safety testing of transgenic foods

� Detection of unintended effects

� Gene transfer

� Traceability and quality assurance

� Societal aspects


Activities

� Duration 200012003

� Meetings� Integrated Discussion Platform

� Plenary, Working Groups

� Management

� Exchange between projects� Training

� Website: www.entransfood.com

� Publications� Working Group papers, Food Chem. Toxicol.

� Overarching report

� Flyer(s)


Outcomes

� Publications, presentations

� Recommendations from WGs

� Integration of research disciplines

� Example for current EU projects

� Intend to continue integrated platform

� Partially continued in EU1funded projects (FP6)

� SAFE FOODS

� NOFORISK


Examples of recommendations� Combination of targeted and non1targeted analysis for safety assessment of GM crops (WG2)

� More efficient detection methods for GM materials against background of their numbers increasing (WG4)

� Research needed on optimalization of public consultation and engagement, as well as on its impact on risk analysis and government institutions (WG5)


Examples of recommendations:

Integrated risk assessment approach (WG1)

SAFETY ASSESSMENT

EXPOSURE ASSESSMENT

2 TRANSFORMATION

History of Gene Insert

3 GENE PRODUCT

-Characterisation

-Mode of action

-Toxicity

-Allergenicity

-Other

Toxicology/Allergy

CONCLUSION ON SAFETY

RISK CHARACTERISATION

HAZARD CHARACTERISATION

HAZARD IDENTIFICATION

1 PARENT CROP

History of Crop Use

Comparison

Toxicology/Nutrition

Allergy (gene transfer)

4 GM CROP/DERIVED FOOD

-Phenotype/agronomy

-Composition

-Nutrition

-Safety evaluation


Antibiotics relevant for human therapy III (avoid)

A) Widely distributed

B) Defined areas of human/veterinary medicine

II (low effect)

A) Widely distributed

B) No or only limited therapeutic relevance

I (no effect)

CharacteristicsGroup

Example of WG3 recommendations: antibiotic

resistance gene classification

Conclusions

� The comparative safety assessment of GM products has worked well and may be further developed in future, for example with supplementary profiling techniques

� The ENTRANSFOOD project has brought together researchers from different disciplines, as well as stakeholders, and its experiences are an example for the current research approach in the EU Sixth Framework Programme for R&D

Illustration: CNN

Illustration:

ESA

Wageningen

RIKILT –Institute of Food Safety

biotechnology and risk assessment: entransfood...“golden rice” with additional β1carotene is an...

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