Post on 19-Dec-2015
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assumptions or outdated data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”
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