Risk assessment of GMOsFOEs view

Werner Müller, GLOBAL 2000

Reg EC 1829/2003 recital 9

Genetically modified food and feed should only be authorised

after a scientific evaluation

of the

highest possible standard

taking uncertainty into account Reg EC 178/2002

FOE has long criticised the poor scientific standard of risk

assessment of GMOs• Sound science: The evidence against

Aventis GM maize (February 2001)

• The great Food Gamble – an assessment of genetically modified food safety (May 2001)

• Bt 11 Briefing (Nov 2003)

1. The choice of the method and design of the experiment predetermines the result

2. Data is not knowledge

Without rules

“Sound science” is like a game

Source: ttp://europa.eu.int/comm/health/ph_determinants/environmentSource: ttp://europa.eu.int/comm/health/ph_determinants/environment/EMF/conf24_26feb2003/gee.pdf/EMF/conf24_26feb2003/gee.pdf

Strengths of the study

• Method– Consistent methodology for all dossiers– Based on state of the art science and not on

assumptions or outdated data

Strengths of the study

• Analysed Parameter– Good separation of tests and arguments in the

dossier– Detailed evaluation of assumptions made by the

applicant– Detailed analysing of tests and corresponding

extrapolation made by the applicant– Good analyses of test-design, statistical analyses

provided by the applicant

Strengths of the study

• Recommended Risk Assessment Protocol

– Standardization (side by side comparison)– New Protocol for Allergenicity Testing– Whole Food Tox studies

What we miss – to complete the picture

• Identify knowledge gaps in Nutrition science– Role/Fate of Food-DNA/RNA in mammalians

• E.g. corn DNA (199bp) in lymphocytes (Einspanier et al 2001) • Identify knowledge gaps in cell biology

– Role of introns? (which have regulatory functions) (Hare et al. 2003, Giacopelli 2003 )

– the role of lacking introns in synthetic transgenes?– Synthetic transgenes stability in F2, F3

• Assessment plant / environment– Synthetic transgenes and heat stress (e.g. VR sugar beet, HT

soybeans, IR cotton)• Identifying NEW Risk Qualities

– Role of Food DNA/RNA with Cell Nucleus• Malatesta et al 2003 increased nucleus

Poor testing of GMOs is not the exemption but seems to be the

standard

Long history of hiding factsis prolonged

Implications

Scientific implications• Need to END assumptions based risk

assessment• Need for a detailed risk assessment protocol• Need for risk research which supports the

competent authorities– Verifying methods– Literature recherché– Identifying knowledge gaps and common patterns

Political implications• Food safety unclear - Consumers a still at risk• There is a need for immediate reassessment of approved

GMOs/ or the approval must be withdrawn• The EU-Commission is not able or unwilling to guarantee a

risk assessment of the “highest possible standard” (e.g Bt 11, NK 603)

• SCF/EFSA was/is not able or unwilling to perform a risk assessment of the “highest possible standard” (e.g Bt 11, NK 603)

• Public trust in EU-Commissions, in Industry and Scientific panels will further decline

Poor Standard of risk assessment is no longer

acceptable

Political implications• Definition of detailed risk assessment

guidance/methods is part of risk management

• EFSA must not define its own rules for risk assessment

• There is a need for supervising EFSA through an Independent Science Panel which should be nominated by NGOs

What next

Risk assessment protocol• New risk concept:

• Exposure profile• Effect profile• Uncertainty profile (see Decis 2002/2715/EC)

• Definition of– Basic requirements for design and statistically

analyses – Methods– Endpoints

Methods

Substantial Equivalence Tox Testing

Basic Methods

Assumption based risk assessment

SCIENCE/Evidence based

risk assessment

EVENT-Specific

Whole Food Tox testing

Tox Testing with Protein (from E.coli)

Methods(Unproved) model

testing risk assessment

Test as consumed risk assessment

Late lessons from Eprex case

orThe real meaning/implications of “EVENT”

Source: Jimenez 2003 / www.bio.org (Biotech industries organisation)

Source: Jimenez 2003 / www.bio.org (Biotech industries organisation)

Source: Jimenez 2003 / www.bio.org (Biotech industries organisation)

Source: Jimenez 2003 / www.bio.org (Biotech industries organisation)

Source: Jimenez 2003 / www.bio.org (Biotech industries organisation)

GM Micro-organism A

GM Micro- organism B

GM Plant A GM Micro- organism B

RISK A RISK B

RISK A RISK B

GENE

GENE

Tox testing with the whole food must be the common minimal

standard

Endpoints

Reg EC 178/2002 Article 14(4)

to take into account not only

• short or middle term effects but also

• effects on future generations

• probable cumulative toxic effects and

• effects on health sensitive consumers.

The game called “sound science”Monsanto and Syngenta proofed in a test-tube design that Bt-Protein is digested within seconds to minutes

Einspanier 2001Chowdhurry 2003detected Bt-Protein in intestine, rectal content of cows, pigs and chicken

There is no need for chronic toxicological

studies

There is a need for chronic toxicological

studies

GM Food consumption

3 x day

7 days a week

Full Lifespan/young and old, fit and ill

Chronic Exposure Chronic Effect testing

Chronic toxicological tests with the whole food must

be the common minimal standard

Evidence based risk assessment protocol

MethodsWhole Food Tox TestingEndpointsChronic Effects, Cancerogenicity

Addressing knowledge gaps

Role and Fate of FOOD-DNA/RNA in mammalians

e.g. maize DNA in lymphocytes

Research funding

Early warning system

Detection of NEW risk qualities

e.g. increase of size nucleus in liver cells

Reliable Institutions

Include alternative risk assessment by NGOs in risk decision making

Transparency

Public Full access to risk assessment parts of dossier

RARM

RC RP/EW

Source: ttp://europa.eu.int/comm/health/ph_determinants/environmentSource: ttp://europa.eu.int/comm/health/ph_determinants/environment/EMF/conf24_26feb2003/gee.pdf/EMF/conf24_26feb2003/gee.pdf