the RiskOGM programme leaflet

RiskOGM Program
In 2010, the French ministry of Ecology, Sustainable Development and Energy
(MEDDE) initiated a research program labeled “RiskOGM’’ (GMORisk).
This program has been set up accordingly to the June 2008 Act on Genetically
modified organisms (GMO). This act establishes the legislative and regulatory
framework practicable in France on GMOs. This act leans on three major elements:
1. Precautionary principle
2. Compatibility principle on the conditions of use of GMOs with strict rules of
coexistence between different types of culture (conventional agriculture with
GMO, conventional agriculture without GMO, organic agriculture)
3. A principle of a triple assessment of the impact of GMOs: sanitary, environmental, and economic (costs and benefits stemming from their use).
Within this renewed legal and regulatory framework, RiskOGM aims at backing up
public decision while contributing to the structuration of an interdisciplinary scientific community. This community has to meet public authorities’ demand in the
fields of expertise, councelling and research on GMOs.
To initiate these dynamics, ministry has launched and
financed two APR (Call for Research project proposals)
since launching RiskOGM, first in 2010, second in 2013.
Main Research Topics
Goal of the 2010 APR (Call for Research Project Proposals-APR) is to nurture discussion on possible developments of the regulatory framework as well as assessment of techniques adapted to new scientific knowledge.
Hence, research fields looked into within this APR cover vast possible research areas on GMOs, among which:
l Regulatory concepts
l Definition of the socio-economic assessment protocole of the GMOs impact
l Demarcation of the assessment framework of the impact of coexistence between sectors of GMO in non-GMO
l Real influence or “Governance’’ of GMOs at national, European or international levels.
After an assessment of pre-listed proposals by the Scientific committee and acknowledgment of
the Orientation Committee, three projects with varied topics have been chosen/selected by the
MEDDE:
l “CRYMUC” - Interactions of the insecticidal Cry toxins with mucus in the digestive tract.
l “DISTRACO” - Dispersion of transgenes of rapeseed (canola): precise role of pollinating insects
and the wind in effective pollination, and dumpsters of harvesting in the dispersal of seeds.
l “EVAGLO” - Contribution to a comprehensive assessment of GMOs: epistemological perspectives
renewed for the risk analysis.
Second APR 2013 aims at improving knowledge on the process of assessment of long term sanitary impacts
of GMOs consumption, so as to contribute to a better evaluation of potential risks in this field.
APR 2013 gave birth to a single consortium based on the research project:
l “ PGM90plus” - Improvement of the predictability of the subchronic toxicity tests used in
the safety assessment of GMOs by identification of biomarkers early of effects.
This project comes in addition of a long term toxicity study on maize NK603. This study is
managed and financed by the European Commission within the 7th European framework
program (FP7), as well as other research projects also financed at European level.
Financed Research Projects
“CRYMUC” - Interactions of the insecticidal Cry toxins
APR 2010
with mucus in the digestive tract
Project: Institute Micalis (UMR1319 INRA-AgroParisTech) - Microbial Genetics and Environment Team
This project focuses on the analysis of the methods used for the assessment of the risks associated with the GMP (genetically
modified plant) expressing insecticidal Cry toxins originating from the bacteria Bacillus thuringiensis. First goal is to understand
if these methods should be modified to take into account the new properties of the toxins Cry, saying the capacity to degrade
digestive tract mucus of insect larvae. Second goal is to identify new projects for studying interactions between Cry toxins and
mucus components from various origins. The issue of this research is to determine if these insecticidal toxins do have an effect
(positive or negative) on mucus cells or on the mucus itself. This could generate new data on the impact of GMO plants on target
and non-target organisms.
“DISTRACO” - Dispersion of transgenes of rapeseed (canola): precise role of pollinating insects and the wind
in effective pollination, and dumpsters of harvesting in the dispersal of seeds
Project: UMR-8079 UPSud-CNRS-AgroParisTech - Unité Ecologie, Systématique et Evolution
Partner: INRA
In the framework of coexistence studies between GMO and NON-GMO cultivations, the issue of this project is to evaluate factors
involved in the transportation of oilseed rape genes via pollen and seeds. This project aims to precisely assess the role of pollinators in the suspension of oilseed rape pollen and its dispersal by wind through greenhouse experiments coupled to a modeling
approach. It aims also to estimate the role of anthropogenic spillage of seeds from grain trailers during harvest in the dynamics of
feral oilseed rape population, by mobilizing assignment by genotyping and modeling approaches.
“EVAGLO” - Contribution to a comprehensive assessment of GMOs:
epistemological perspectives renewed for the risk analysis
Project: Association Group International of Transdisciplinary Studies
Partners: UMR-5600, INSA - Association for the Emergence of a University of Life (Association Pour l’Emergence d’une
Université du Vivant); Institute for Complex Systems Paris-Ile-de-France (ISC-PIF); Integrative Immunology Laboratory UMR7211
CNRS UPMC
Human activity, especially through technical innovations, degrade biodiversity and “biogée” at high pace, and this despite numerous programs settled to stop or slow this deleterious evolution.
Presently ongoing methods to assess impact of new technologies, GMOs in particular, do not respond to present issues aiming at
securing human species, even though it is neither possible or desirable to stop techno-scientific innovation due to our civilization’s
intrinsic addiction to the latter. Major concern of the modern world can be put this way: ‘’How far is too far?’’. This question in form
of anacoluthon cannot be dealt with through traditional analytical methods. The present project offers to supplement traditional
evaluation methods by a global approach, through three research axes.
First of all, one needs to know whether such or such category of actions interferes with the organisation itself, in particular the
complex ‘’biogée’’ (biosphere system and abiotic system) without trying to determine how could show the systemic answers to
these interferences. Secondly, the project will evaluate the detection methods of forerunner signals of systemic collapse. Lastly,
the project tries to determine if it is possible to develop biologic systems allowing testing scale invariants (project proposes to use
thymus as a biological support).
Goal is to suggest tracks so that a growing group of researchers can take a grasp of it and bring forward essential tools
for modern society.
APR 2013
“PGM90plus” - Improvement of the predictability of the subchronic
toxicity tests used in the safety assessment of GMOs by identification
of biomarkers early of effects
Project: Unit Toxalim, INRA UMR1331
Partners: INRA; INSERM; CNRS; HANDLES; Universities (Toulouse, Rennes1, Paris Descartes,
Bordeaux, Lyon); Profilomic; Methodomics; LA - SER Analytica; Laberca; Agilent
This project is supported by a consortium gathering various scientific experts in the areas of crop production and analytical characterization, the biology of systems, toxicology, pathophysiology, statistics
and modeling, as well as humanities and social sciences. Its goal is to determine if feeding of rats with
genetically modified maize results in metabolic changes that could be linked to early effect biomarkers
(measurable biological characteristic). The issue is to supply key data that can be used in different processes of risk assessment. All of these milestones constitute also a permanent dialogue with different
stakeholders (associations, companies, trade unions) in the project. The purpose of this research is to
determine if the supply of rats with genetically modified maize induced metabolic changes that may be
related to early biomarkers of effects. The challenge is to provide key data that can be used in the risk
assessment process. To do this, the GMO90plus proposes to optimize the predictive nature of the test
of subchronic toxicology in 90-day rat. Proposed by European Agency EFSA, it is used today in the
context of the procedures of safety assessment of genetically modified plants. Therefore, it will follow
in rats fed with GM crops and control various biological parameters, for 6 months. Then these results will
be interpreted on the basis of concepts and the latest technologies (including omics and Biostatistics).
The consortium chose maize as genetically modified food because it comes at the outset of the second
GM plant currently used and produced at the global level for food purposes. It was also chosen for ease
of comparison with projects funded under the 7th European framework program (FP7) in progress.
Search for early biomarkers is based on one hand on a six month experimentation, and on the other on
a strong interaction with financed projects within the 7th European framework-program GRACE (3 months
and one year) and G-YwYST (3 months and 2 years).
Two genetically modified types of corn have been selected:
l maize MON810, expressing the insecticidal protein of Bacillus thuringiensis (Bt toxin), because of its
use in the GRACE and G-TwYST research project;
l maize NK603, resistant to the herbicide glyphosate, because of its use in the project G-TwYST.
Both projects, GMO90+ and G-TwYST will use same food and rat strain.
Under the Protocol of this research, samples of organs, urine, and blood samples monthly bodies are
carried out during six months in rats of both sexes to find biomarkers by techniques «omics» broadband
(metabolomics, transcriptomics and proteomic). The results are then analysed by specialists of physio-pathology, in particular of hepato-gastro-intestinal, reproductive, and urinary systems. Samples (urine,
blood, liver, kidney) after 1 and 2 years feeding from the G-TwYST project will be analyzed allowing to
follow the rats during 2 years and consequently to identify and validate biomarkers of interest in close
relationship with the coordinators of the other related projects of the FP7. Biological and data values
pathophysiological will benefit from the games of data from GRACE and G-TwYST programs that follow
rats of the same strain on 1 and 2 years. All these data will be freely accessible on a website.
What is at Stake
The progress in the field of molecular biology and that of fundamental biological mechanisms expertise
entail noticeable evolutions in genetic engineering. This allows a greater mastering of these techniques.
These technical improvements come along with a broad distribution of Genetically modified organs (GMO),
more specifically cultures of Genetically modified plants (GMP) in several regions of the globe.
This innovation leads to reassess sanitary risks and benefits both environmental and economic of GMOs
in short and long range. It also leads to reassess their regulatory frame as well as their evaluation methods.
As for sanitary risks and benefits, there are different scientific positions. Some experts consider
that there is no reason for debate while others assert on the contrary that present state of scientific knowledge cannot presume on the long term effects of GMOs consumption and that progress
in scientific research is needed. Yet, other experts urge for vigilance so as to detect possible and
potential weak signals of sanitary effects. Nonetheless, the same experts consider that present
mandatory studies before commercialization constitutes a guarantee for a high level of sanitary
security.
Same variations appear in the field of environment where scientific opinions diverge on methodologies and territories surveillance markers. These techniques are used to prevent any possible non
intentional effects on environment of agricultural practices. There is also some difference of opinions on the management politics and the technical means to put in use within a coexistence of
various types of culture (conventional agriculture with GMO, conventional agriculture without GMO,
organic agriculture).
Socio-economic analysis of the impact of GMO is no less subject to controversy. As of
today there is no unanimity on pertinent methods to put in action in order to decipher
and define costs and benefits with various actors of the food-processing industries.
Today there is a high stake to feed public action with new
knowledge. This will allow to bring objective data on long
term potential effects of GMOs. These data would
consequently allow to go along with an adjustment
of regulation to scientific and technical developments.
Program Authorities
Management of the research program RiskOGM of the ministry of Ecology, Sustainable Development and
Energy (MEDDE) depends on two bodies:
l The Orientation Committee - Made up of representatives of ministries as well as stakeholders (See members’ list hereunder), the Orientation Committee (OC) contributes to the expression of the needs of public
stakeholders. It also contributes to the building of pertinent strategy of the program, and to the circulation
of thoughts et research works.
l The Scientific Council - Made up of researchers from all concerned disciplines (See members’ list hereunder), the Scientific Council (SC) formulates scientific issues, guarantees scientific pertinence of research,
and insures the assessment of the scientific quality of research proposals. It also contributes to research
works enhancement.
Members of Orientation Committee
National Agency for Research - Agence Nationale de la Recherche (ANR)
National Agency for Sanitary Security of Food,Environment and Work - Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES)
Permanent Assembly of Chambers of Agriculture - Assemblée Permanente des Chambres d’Agriculture (APCA)
European Authority of Sanitary Security of Food - Autorité Européenne de Sécurité sanitaire des aliments (EFSA)
Research Commitee and Independent Data on GENetic Engineering - Comité de Recherche et d’Information Indépendantes sur le génie GENétique (CRIIGEN)
France Nature Environment - France Nature Environnement (FNE)
Greenpeace France
Study and Control Group on Varieties and Seeds - Groupe d’étude et de contrôle des variétés et des semences (GEVES)
National Interprofessional Association for Seeds - Groupement National Interprofessionnel des Semences (GNIS)
French ministry of Ecology, Sustainable Development and Energy - Ministère de l’Environnement, du Développement Durable et de l’Energie (MEDDE) - General
Commission for Sustainable Development - Commissariat Général du Développement Durable (CGDD) - Management of Research and Innovation - Direction de la
Recherche et de l’Innovation (DRI) - Research Department - Service de la Recherche (Président du CO)
MEDDE - General Directorate for Prevention of Risks (Direction Générale de la Prévention des Risques)
MEDDE - General Directorate for Planning, Housing and Nature - Direction Générale de l’Aménagement, du Logement et de la Nature
Ministry of Research - General Directorate for Researchand Innovation - Ministère de la Recherche - Direction Générale de la Recherche et de l’Innovation
Ministry of Health - General Directorate for Health - Ministère de la Santé - Direction Générale de la Santé
Ministry of Agriculture, Agri-food and Forestry - General Directorate for Food - Ministère de l’Agriculture, de l’Agroalimentaire et de la Forêt, Direction Générale de l’Alimentation
Ministry of Economy and Finance - General Directorate for Competition, Consumer Affairs and Prevention of Fraud (DGCCRF) - Ministère de l’Economie et des
Finances, Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes
Movement for Rights and Respect of Future Generations - Mouvement pour le Droit et le Respect des Générations Futures (MDRGF)
Organisation for Economic Co-operation and Development (OECD) - Organisation de Coopération et de Développement Economiques
UFC Que choisir (monthly magazine)
Members of the Scientific Council
First Name
Name
Organization / expertise
Yves
Sylvie
Anne-Marie
Denis
Michel
Pierre-Henri
Michel
Joël
Pierre-Benoît
Stéphane
Rémi
Antoine
Christine
Bertheau
Chevillard
Chevre
Couvet
Dron
Gouyon
Griffon
Guillemain
Joly
Lemarie
Maximilien
Messean
Noiville
INRA / molecular biology
CEA / toxicology
INRA / genetics
MNHN / agro-ecology
Université Paris-Sud 11 / biology, molecular biology
MNHN / biology - ecology
ANR / macro-economy, markets, prospective
CNRS / toxicology
INRA-IFRIS / sociology
INRA / economics
CEA / toxicology
INRA / agronomy-ecology
Université Paris I - CNRS / law
Contact
Ministry of Ecology, Sustainable Development and Energy Ministère de l’Environnement, du Développement Durable et de
l’Energie (MEDDE)
General Commission for Sustainable Development - Commissariat
Général du Développement Durable (CGDD)
Management of Research and Innovation - Direction de la
Recherche et de l’Innovation (DRI)
Research Department (SR)
(Ministère de l’Environnement, du Développement Durable et de
l’Energie (MEDDE)
Commissariat Général du Développement Durable (CGDD)
Direction de la Recherche et de l’Innovation (DRI)
Service de la Recherche (SR)
Lionel Moulin, Manager of the project Risks Environment Health
(Responsable de la mission risques environnement santé)
Dominique Thierry, Project Executive for Risks Environment Health
(Chargé de mission risques environnement santé)
Céline Coudert-Obert, Project Executive for Risks Environment
Health (Chargé de mission risques environnement santé)
Single Contact Address (Adresse unique de contact):
[email protected]
Follow the RiskOGM program:
www.rechercheriskogm.fr
Conception : Langevin & Associés - www.langevinassocies.eu • Design graphique : René Bertramo - www.legig.com
Chairman of the Scientific Council of the RiskOGM program - Président du Conseil Scientifique du programme RiskOGM