Mardis de l'AIGx - Patrick DUJARDIN

QuepenserdesOGM?

Pr.PatrickduJardin

GemblouxAgro‐BioTech,UniversitédeLiège(BE)

[email protected]

OGM:«Organismedontlematérielgéné1queaétémodifiéd’unemanière

quines’effectuepasnaturellementparmul1plica1onet/ouparrecombinaisonnaturelle»

(DirecLvesdel’EU)

LesOGMcul1vésaujourd’hui

I S A A A

Source: Clive James, 2012

Global Area of Biotech Crops, 1996 to 2011:

Industrial and Developing Countries (M Has, M Acres)

0

20

40

60

80

100

120

140

160

180

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

0

49

99

148

198

247

296

346

395

445

M Acres

Total

Industrial

Developing


I S A A A

0

10

20

30

40

50

60

70

80

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

Soybean

Maize

Cotton

Canola

M Acres

0

25

49

74

99

124

148

173

198


By Crop (Million Hectares, Million Acres)


I S A A A

Global Adoption Rates (%) for Principal

Biotech Crops (Million Hectares, Million Acres), 2011


M Acres

0

20

40

60

80

100

120

140

160

180

82%

Cotton

75%

Soybean

32%

Maize

26%

Canola

30

100

159

31

Conventional

Biotech

0

49

99

148

198

247

296

346

395

445


I S A A A


By Trait (Million Hectares, Million Acres)


0

10

20

30

40

50

60

70

80

90

100

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

Herbicide Tolerance

Insect Resistance (Bt)

Herbicide Tolerance/

Insect resistance

0

25

49

74

99

124

148

173

198

222

247

M Acres

ISAAAreport:GlobalStatusofCommercializedBiotech/GMCrops:2010

Country vs. Year 2007 2008 2009 2010

Bt maize 2010

Amflora 2010 Total

Spain 75148 79269 76057 76575 - 76575

France 21174 - - - - -

Czech Republic 5000 8380 6480 4680 150 4830

Portugal 4263 4851 5094 4868 - 4868

Germany 2685 3173 - - 15 15

Slovakia 900 1900 875 1248 - 1248

Romania 350 7146 3244 822 - 822

Poland 327 3000 3000 3000 - 3000

Sweden - - - - 80 80

Total 88673 107719 94750 91193 245 91438

AgriculturalBiotechnologyinEuropePlanLngfigures(inha)

ISAAAreport:GlobalStatusofCommercializedBiotech/GMCrops:2010

PlantesGMtolérantesàdesherbicidestotaux

+Roundup ‐Roundup

Planterésistanteauxinsectesravageurs‐LatechnologieBt:faireproduireparlaplanteunbioinsec1ded’origine

bactérienne(Bacillusthuringiensis)

UnepommedeterreGMexprimantungèned’unepommedeterresauvagerésistanteaumildiou

h[p://www.youtube.com/watch?v=T1hC5mxLkIc

Deschampsd’essaienBelgique,mais...

Lerizdoré(Goldenrice),enrichienpro‐vitamineA:commercialiséen2014?

Risques

Risque≠danger≠dommage

L’évalua1ondesrisques,uneaffairedespécialistes

SiteswebofficielssurlesOGMenBelgique:

•  SiteduConseilconsultaLfbelgedebiosécurité:h[p://www.bio‐conseil.be/

•  SitetrèscompletsurlasituaLonréglementairebelgeeteuropéenne:h[p://www.biosafety.be/

•  SPF,siteOGM:h[p://www.health.belgium.be/eportal/Environment/BiodiversityandGMO/GMOs/

Uneagenceeuropéennepourl’évalua1ondesrisquesavantmisesurlemarché:l’EFSA(EuropeanFoodSafetyAuthority,Parme,IT)

UnavisrendusurchaqueOGMdesLnéàrentrerenEU(miseenculture,importaLonettransformaLon,alimentspouranimaux,ingrédientsissusd’OGM,etc.)

Paneld’expertsOGMdel’EFSA(2012‐2015)

Procédureeuropéenned’autorisaLon:Règlement1829/2003

Evalua1onexpostdesrisquespourlasantéhumaineetanimaleetpourl’environnement

•  Leconstatd’unhautniveaudesécurité

•  Lanécessitéd’affinerlesdisposiLfsdesurveillanceetdetraçabilité•  LanatureessenLellementdynamiqueduPrincipedeprécauLon

ART-Schriftenreihe 1

Ecological impacts of genetically modified crops

Experiences from ten years of experimental field research and commercial cultivation

Olivier Sanvido, Michèle Stark, Jörg Romeis and Franz Bigler

| October 2006

sr_art1.indd isr_art1.indd i 10.10.2006 10:29:2610.10.2006 10:29:26

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!

SOCIETY OF TOXICOLOGY POSITION PAPER

The Safety of Genetically Modified Foods Producedthrough Biotechnology

Executive Summary

The Society of Toxicology (SOT) is committed to protectingand enhancing human, animal, and environmental healththrough the sound application of the fundamental principles ofthe science of toxicology. It is with this goal in mind that theSOT defines here its current consensus position on the safety offoods produced through biotechnology (genetic engineering).These products are commonly termed genetically modifiedfoods, but this is misleading, since conventional methods ofmicrobial, crop, and animal improvement also produce geneticmodifications and these are not addressed here.

The available scientific evidence indicates that the potentialadverse health effects arising from biotechnology-derivedfoods are not different in nature from those created by con-ventional breeding practices for plant, animal, or microbialenhancement, and are already familiar to toxicologists. It istherefore important to recognize that the food product itself,rather than the process through which it is made, should be thefocus of attention in assessing safety.

We support the use of the substantial equivalence concept aspart of the safety assessment of biotechnology-derived foods.This process establishes whether the new plant or animal issignificantly different from comparable, nonengineered plantsor animals used to produce food that is generally considered tobe safe for consumers. It provides critical guidance as to thenature of any increased health hazards in the new food. Toestablish substantial equivalence, extensive comparative stud-ies of the chemical composition, nutritional quality, and levelsof potentially toxic components, in both the engineered andconventional crop and animal, are conducted. Notable differ-ences between the existing and new organism would requirefurther evaluation to determine whether the engineered formpresents a higher level of risk. Through this approach, thesafety of current biotechnology-derived foods can be comparedwith that of their conventional counterparts, using established

and accepted methods of analytical, nutritional, and toxicolog-ical research.

Studies of this type have established that the level of safetyto consumers of current genetically engineered foods is likelyto be equivalent to that of traditional foods. At present, noverifiable evidence of adverse health effects of BD foods hasbeen reported, although the current passive reporting systemprobably would not detect minor or rare adverse effects or amoderate increase in effects with a high background incidencesuch as diarrhea.

The changes in the composition of existing foods producedthrough biotechnology are quite limited. Assessing safety maybe more difficult in the future if genetic engineering projectscause more substantial and complex changes in a foodstuff.Methods have not yet been developed with which whole foods(in contrast to single chemical components) can be fully eval-uated for safety. Progress also needs to be made in developingdefinitive methods for the identification and characterization ofproteins that are potential allergens, and this is currently amajor focus of research. Improved methods of profiling plantand microbial metabolites, proteins and gene expression maybe helpful in detecting unexpected changes in BD organismsand in establishing substantial equivalence.

A continuing evolution of toxicological methodologies andregulatory strategies will be necessary to ensure that thepresent level of safety of biotechnology-derived foods is main-tained in the future.

Introduction

The Society of Toxicology (SOT) is committed to protectingand enhancing human, animal, and environmental healththrough the sound application of the fundamental principles ofthe science of toxicology. It is with this goal in mind that theSOT defines here its current consensus position on the safety offoods produced through biotechnology. In this context, bio-technology is taken to mean those processes whereby genesthat are not endogenous to the organism (transgenes) are trans-ferred to microorganisms, plants, or animals employed in foodproduction, or where the expression of existing genes is per-manently modified, using the techniques of genetic engineer-ing. We intentionally avoid using the term genetically modifiedorganisms (GMOs) or foods in this context, since conventionaltechniques of plant and animal breeding, which are not con-

This document was written by the SOT ad hoc Working Group and has beenreviewed by the SOT membership and approved by the SOT Council. TheWorking Group membership consisted of Robert M. Hollingworth, MichiganState University; Leonard F. Bjeldanes, University of California Berkeley;Michael Bolger, U.S. Food and Drug Administration; Ian Kimber, Syngenta;Barbara Jean Meade, National Institute of Occupational Safety and Health;Steve L. Taylor, University of Nebraska; and Kendall B. Wallace, Universityof Minnesota.

TOXICOLOGICAL SCIENCES 71, 2–8 (2003)Copyright © 2003 by the Society of Toxicology

2

sidered here, also involve genetic modification. The extent ofthe genetic changes resulting from such conventional breedingtechniques, which is generally undefined, far exceeds thattypically produced by transgenic methods. Consequently, it isimportant to recognize that it is the product, and not the processof modification, that is the focus of concern regarding thehuman or environmental safety of biotechnology-derived (BD)foods.

The principal responsibilities of toxicologists are to defineand characterize the potential for natural and manufacturedmaterials to cause adverse health effects and to assess, asaccurately as possible, the plausibility and level of risk forhuman or animal health or for environmental damage under adefined set of circumstances. It is not the task of the Society ofToxicology to determine the overall value of a product orprocess by balancing health or environmental risks with po-tential benefits, or to choose between different strategies tomanage risk, although toxicological considerations are impor-tant in both processes. Our purpose here is rather to identifyand consider the primary toxicological issues associated withBD foods. Major areas of concern in the development andapplication of such foods in agriculture relate to the possibilityof deleterious effects on both human health and the environ-ment. We do not consider here some aspects of the possibleenvironmental impact of GM organisms such as gene transferto nonengineered plants.

Types of Toxicological Hazards to Consumers andProducers Associated with BD Foods

Current techniques of developing organisms used in theproduction of BD foods typically involve the transfer to thehost of the desired gene or genes in combination with apromoter and a gene for a selectable marker trait that allows theefficient isolation of cells or organisms that have been trans-formed from those that have not. Common selectable markersin plants have included resistance to antibiotics (kanamycin/neomycin or ampicillin) or herbicides.

Several key issues have been raised with respect to thepotential toxicity associated with BD foods, including theinherent toxicity of the transgenes and their products, andunintended (pleiotropic or mutagenic) effects resulting fromthe insertion of the new genetic material into the host genome.Unintended effects of gene insertion might include an over-expression by the host of inherently toxic or pharmacologicallyactive substances, silencing of normal host genes, or alterationsin host metabolic pathways. It is important to recognize that,with the exception of the introduction of marker genes, theprocess of genetic engineering does not, in itself, create newtypes of risk. Most of the hazards listed above are also inherentin conventional breeding methods.

The Concept of Substantial Equivalence

The guiding principle in the evaluation of BD foods byregulatory agencies in Europe and the U.S. is that their human

and environmental safety is most effectively considered, rela-tive to comparable products and processes currently in use.From this arises the concept of “substantial equivalence.” If anew food is found to be substantially equivalent in compositionand nutritional characteristics to an existing food, it can beregarded as being as safe as the conventional food (FDA, 1992;Kuiper et al., 2001; Maryanski, 1995; OECD, 1993) and doesnot require extensive safety testing. Evaluation of substantialequivalence includes consideration of the characteristics of thetransgene and its likely effects within the host, and measure-ments of protein, fat, and starch content, amino acid composi-tion, and vitamin and mineral equivalency together with levelsof known allergens and other potentially toxic components. BDfoods can either be substantially equivalent to an existingcounterpart, substantially equivalent except for certain defineddifferences (on which further safety assessments would thenfocus), or nonequivalent, which would mean that more exten-sive safety testing might be necessary. The examination ofsubstantial equivalence, therefore, may be only the startingpoint of the safety assessment. It provides a valuable guide tothe definition of potential hazards from BD foods and illumi-nates necessary areas for further study (FAO/WHO, 2000).While there is some concern relative to the meaning of “sub-stantial” and how equivalency should be established, and de-bate over its use continues (e.g., see Millstone et al., 1999 andfollowing correspondence; Kuiper et al., 2001; Royal Societyof Canada, 2001), the concept appears to be logical and robustin assessing the safety of foods derived from both geneticallymodified plants and microorganisms (FAO/WHO, 2000,2001a). If it can be established with reasonable certainty that aBD food is no less safe than its conventional counterpoint, itprovides a standard likely to be satisfactorily protective ofpublic health. It is also an approach that has the flexibility toevolve in concert with the field of transgenic technology. Arecent study of FDA procedures for assessing the safety of BDfoods by the U.S. General Accounting Office reviews theseprocedures and concludes that the current regimen of safetytests are adequate to assess existing BD foods (U.S. GeneralAccounting Office, 2002).

Key Issues with Respect to Human Health Effects of BDFoods

Is the Transgene Itself Toxic? Can it be Transferred to theGenome of a Consumer?

Humans typically consume a minimum of 0.1 to 1 gram ofDNA in their diet each day (Doerfler, 2000). Therefore, thetransgene in a genetically engineered plant is not a new type ofmaterial to our digestive systems, and it is present in extremelysmall amounts. In transgenic corn, the transgenes representabout 0.0001% of the total DNA (Lemaux and Frey, 2002).Decades of research indicate that dietary DNA has no directtoxicity itself. On the contrary, exogenous nucleotides havebeen shown to play important beneficial roles in gut function

3SOCIETY OF TOXICOLOGY POSITION PAPER

Long term toxicity of a Roundup herbicide and a Roundup-tolerantgenetically modified maize

Gilles-Eric Séralini a,!, Emilie Clair a, Robin Mesnage a, Steeve Gress a, Nicolas Defarge a,Manuela Malatesta b, Didier Hennequin c, Joël Spiroux de Vendômois a

aUniversity of Caen, Institute of Biology, CRIIGEN and Risk Pole, MRSH-CNRS, EA 2608, Esplanade de la Paix, Caen Cedex 14032, FrancebUniversity of Verona, Department of Neurological, Neuropsychological, Morphological and Motor Sciences, Verona 37134, ItalycUniversity of Caen, UR ABTE, EA 4651, Bd Maréchal Juin, Caen Cedex 14032, France

a r t i c l e i n f o

Article history:Received 11 April 2012Accepted 2 August 2012Available online xxxx

Keywords:GMORoundupNK603RatGlyphosate-based herbicidesEndocrine disrupting effects

a b s t r a c t

The health effects of a Roundup-tolerant genetically modified maize (from 11% in the diet), cultivatedwith or without Roundup, and Roundup alone (from 0.1 ppb in water), were studied 2 years in rats. Infemales, all treated groups died 2–3 times more than controls, and more rapidly. This difference was vis-ible in 3 male groups fed GMOs. All results were hormone and sex dependent, and the pathological pro-files were comparable. Females developed large mammary tumors almost always more often than andbefore controls, the pituitary was the second most disabled organ; the sex hormonal balance was mod-ified by GMO and Roundup treatments. In treated males, liver congestions and necrosis were 2.5–5.5times higher. This pathology was confirmed by optic and transmission electron microscopy. Markedand severe kidney nephropathies were also generally 1.3–2.3 greater. Males presented 4 times more largepalpable tumors than controls which occurred up to 600 days earlier. Biochemistry data confirmed verysignificant kidney chronic deficiencies; for all treatments and both sexes, 76% of the altered parameterswere kidney related. These results can be explained by the non linear endocrine-disrupting effects ofRoundup, but also by the overexpression of the transgene in the GMO and its metabolic consequences.

! 2012 Elsevier Ltd. All rights reserved.

1. Introduction

There is an ongoing international debate as to the necessarylength of mammalian toxicity studies in relation to the consump-tion of genetically modified (GM) plants including regular meta-bolic analyses (Séralini et al., 2011). Currently, no regulatoryauthority requests mandatory chronic animal feeding studies tobe performed for edible GMOs and formulated pesticides. How-ever, several studies consisting of 90 day rat feeding trials havebeen conducted by the biotech industry. These investigationsmostly concern GM soy and maize that are rendered either herbi-

cide tolerant (to Roundup (R) in 80% of cases), or engineered toproduce a modified Bt toxin insecticide, or both. As a result theseGM crops contain new pesticide residues for which new maximalresidual levels (MRL) have been established in some countries.

If the petitioners conclude in general that there is no majorchange in genetically modified organism (GMO) subchronic toxic-ity studies (Domingo and Giné Bordonaba, 2011; Hammond et al.,2004, 2006a,b), significant disturbances have been found andmay be interpreted differently (Séralini et al., 2009; Spiroux deVendômois et al., 2010). Detailed analyses have revealed altera-tions in kidney and liver functions that may be the signs of earlychronic diet intoxication, possibly explained at least in part bypesticide residues in the GM feed (Séralini et al., 2007; Spirouxde Vendômois et al., 2009). Indeed, it has been demonstrated thatR concentrations in the range of 103 times below the MRL inducedendocrine disturbances in human cells (Gasnier et al., 2009) andtoxic effects thereafter (Benachour and Seralini, 2009), includingin vivo (Romano et al., 2012). After several months of consumptionof an R-tolerant soy, the liver and pancreas of mice were affected,as highlighted by disturbances in sub-nuclear structure (Malatestaet al., 2008a, 2002a,b). Furthermore, this toxic effect was repro-duced by the application of R herbicide directly to hepatocytes inculture (Malatesta et al., 2008b).

0278-6915/$ - see front matter ! 2012 Elsevier Ltd. All rights reserved.http://dx.doi.org/10.1016/j.fct.2012.08.005

Abbreviations: GM, genetically modified; R, Roundup; MRL, maximal residuallevels; GMO, genetically modified organism; OECD, Organization for Economic Co-operation and Development; GT, glutamyl-transferase; PCA, principal componentanalysis; PLS, partial least-squares; OPLS, orthogonal partial least-squares; NIPALS,Nonlinear Iterative Partial Least Squares; OPLS-DA, Orthogonal Partial Least SquaresDiscriminant Analysis; G, glycogen; L, lipid droplet; N, nucleus; R, rough endoplas-mic reticulum (on microscopy pictures only); U, urinary; UEx, excreted in urineduring 24 h; APPT, Activated Partial Thromboplastin Time; MCV, Mean CorpuscularVolume; PT, Prothrombine Time; RBC, Red Blood Cells; ALT, alanine aminotrans-ferase; MCHC, Mean Corpuscular Hemoglobin Concentration; A/G, Albumin/Glob-ulin ratio; WBC, White Blood Cells; AST, aspartate aminotransferase.! Corresponding author. Tel.: +33 (0)231565684; fax: +33 (0)231565320.

E-mail address: [email protected] (G.-E. Séralini).

Food and Chemical Toxicology xxx (2012) xxx–xxx

Contents lists available at SciVerse ScienceDirect

Food and Chemical Toxicology

journal homepage: www.elsevier .com/locate / foodchemtox

Please cite this article in press as: Séralini, G.-E., et al. Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. FoodChem. Toxicol. (2012), http://dx.doi.org/10.1016/j.fct.2012.08.005

Unedésinforma1onorganisée

PERSPECTIVE

Plurality of opinion, scientific discourse and pseudoscience:an in depth analysis of the Seralini et al. study claimingthat RoundupTM Ready corn or the herbicide RoundupTM

cause cancer in rats

Gemma Arjo • Manuel Portero • Carme Pinol • Juan Vinas •

Xavier Matias-Guiu • Teresa Capell • Andrew Bartholomaeus •

Wayne Parrott • Paul Christou

Received: 20 December 2012 / Accepted: 2 February 2013! Springer Science+Business Media Dordrecht 2013

Abstract A recent paper published in the journal

Food and Chemical Toxicology presents the results ofa long-term toxicity study related to a widely-used

commercial herbicide (RoundupTM) and a Roundup-

tolerant genetically modified variety of maize, con-cluding that both the herbicide and the maize varieties

are toxic. Here we discuss the many errors andinaccuracies in the published article resulting in highly

misleading conclusions, whose publication in the

scientific literature and in the wider media has causeddamage to the credibility of science and researchers in

the field. We and many others have criticized the

study, and in particular the manner in which the

experiments were planned, implemented, analyzed,interpreted and communicated. The study appeared to

sweep aside all known benchmarks of scientific good

practice and, more importantly, to ignore the minimalstandards of scientific and ethical conduct in particular

concerning the humane treatment of experimentalanimals.

Keywords Safety assessment ! GM crops !Toxicity ! GM maize

G. Arjo ! C. PinolDepartament de Medicina, Universitat de Lleida-Institutde Recerca Biomedica de Lleida (IRBLleida),Lleida, Spain

M. PorteroDepartament de Medicina Experimental, Universitatde Lleida-Institut de Recerca Biomedica de Lleida(IRBLleida), Lleida, Spain

J. VinasDepartament de Cirurgia, Universitat de Lleida-Institut deRecerca Biomedica de Lleida (IRBLleida), Lleida, Spain

J. Vinas ! X. Matias-GuiuHospital Universitari Arnau de Vilanova, Lleida, Spain

X. Matias-GuiuDepartament de Ciencies Mediques Basiques, Universitatde Lleida-Institut de Recerca Biomedica de Lleida(IRBLleida), Lleida, Spain

T. Capell ! P. Christou (&)Departament de Produccio Vegetal i Ciencia Forestal,Universitat de Lleida-Agrotecnio Center, Lleida, Spaine-mail: [email protected]

A. BartholomaeusSchool of Pharmacy, University of Canberra, Canberra,Australia

A. BartholomaeusTherapeutic Research Unit, School of Medicine,University of Queensland, Brisbane, Australia

W. ParrottDepartment of Crop and Soil Sciences, Institute for PlantBreeding, Genetics and Genomics, University of Georgia,Athens, GA, USA

P. ChristouInstitucio Catalana de Recerca i Estudis Avancats,Barcelona, Spain

123

Transgenic Res

DOI 10.1007/s11248-013-9692-9

Approvals of GMOs in the European Union 29

These 10 countries represent only 15% of the total EU population, less than a fifth of EU cereal pro-duction, about a fifth of EU oilseed production and only a quarter of the total votes in Council.21

The six smallest of these countries, because of their limited market size, are commercially less in-teresting. Most of these countries import GM feed to feed their animals.

FIGURE 9: Detailed voting pattern of each Member State

The chart shows that 10 countries vote against the EFSA scientific opinion ranging upwards of 63% of the time. The percentages incorporate all votes made in Standing Committee and Council (upwards of 60 votes for some countries).

Impact of issueVoting against the EFSA scientific opinion slows down the approval process. It also politicises the scientific opinion. Several countries openly admit that their vote is political and not based on sci-entific considerations. By disregarding the sci-entific opinion, they prevent the GM regulatory

framework, which was agreed in full co-decision between Member States and European Parliament from working as intended. This voting pattern is preventing new GM product authorisations and stopping other Member States from providing ac-cess to new products to their farmers.

Member States voting against EFSA scientific opinion

0%0%0%0%1%1%4%4%4%4%5%12%13%20%38%42%57%63%69%77%85%93%94%98%99%100%100%

% negative votes

AustriaLuxembGreeceCyprusPoland

HungaryLithuaniaSlovenia

MaltaLatvia

ItalyDanmark

FranceBelgiumSlovakiaPortugal

EstoniaGermany

IrelandBulgariaRomania

SpainUK

CzechFinland

NetherlaSweden

Yes No Abstain

COMMENTS ON THE EU AUTHORISATION SYSTEM

“…we’ve created a state-of-the-art machinery for handling GMOs, we’re really struggling to use it as well as we could be … vital time is

being lost in procedures… The result is that a growing number of GM

products are widely used in other parts of the world, but are not yet authorised in the European Union.”

Mariann Fischer BoelEU Commissioner for Agriculture and Rural

Development Speech, 15 October 2009

—

It is: “…necessary to look for improvement of the implementation

of this legal framework in order to better meet the objectives

of the EC legislation, taking into consideration the necessity of

continuing processing applications without undue delays…”

2912th Environment Council Conclusions Unanimously agreed on 4 December 2008

—

“One possibility to avoid the situation above from occurring is to speed up the authorisation

processes for novel GM products.”

“Study on the Implications of Asynchronous GMO Approvals for EU Imports of Animal Feed

Products”.2010 Report financed,

presented by the European Commission.







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Lenteurduprocessusd’autorisa1ondemisesurlemarchéEU

Approvals of GMOs in the European Union 11

Time required in four different authorisation frameworks Even if GM dossiers are submitted at the same time in different parts of the world, authorisa-tions are not granted simultaneously. GM product authorisations in the EU take substantially longer than in the GM exporting countries. On average a GM import dossier takes almost four years to pass through the EU approval process.

It is noteworthy that the EU differentiates between an import and a cultivation dossier, while in Brazil and the US, and with some exceptions, in Canada, the distinction is not made; authorisations are giv-en for the full scope of planting, import and con-sumption. Contrary to these other countries, the EU requires new approval for stacked products, even if those traits were previously authorised separately.

FIGURE 2: Average time required for a GM product approval in the EU, US, Brazil and Canada

Average time required for a GM product approval

45

25

27

30

0 5 10 15 20 25 30 35 40 45 50

Time (in months)

European Union

United States

Brazil

Canada







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Education

Mardis de l'AIGx - Patrick DUJARDIN