Rannsókn bendir til skaðlegra heilsufarsáhrifa erfðabreyttra afurða

Fimm landssamtök og þjónustuaðilar hvetja til breyttrar stefnumótunar og meiri aðgæslu

Ný frönsk vísindarannsókn bendir til þess að langtíma neysla erfðabreyttra afurða kunni að hafa neikvæð áhrif á heilsufar. Rannsóknin sýnir skaðleg heilsufarsáhrif erfðabreytts maísyrkis sem víða er notað í dýrafóður og matvæli og varpar hún þar með ljósi á alvarlegar brotalamir í leyfisveitingakerfi sem notast er við í Evrópu og hér á landi. Af þessu tilefni hafa fimm landssamtök og þjónustuaðilar skorað á stjórnvöld að stöðva leyfisveitingar til útiræktunar á erfðabreyttum plöntum hér á landi, þar til fram hefur farið gagnger endurskoðun á regluverki slíkra leyfisveitinga. Í opnu bréfi sem þessir aðilar hafa sent stjórnvöldum er þess einnig krafist að vísindarannsóknir sem lagðar eru til grundvallar leyfisveitingum verði gerðar gegnsærri og óháðari hagsmunum líftæknifyrirtækja.

Reykjavík 12. október 2012

Opið bréf til stjórnvalda um útiræktun erfðabreyttra plantna

Vakin er athygli stjórnvalda á niðurstöðum rannsóknar sem nýverið var kynnt í Frakklandi og leiddi í ljós hver langtíma áhrif neyslu erfðabreyttra afurða á heilsufar kunna að verða. Rannsóknin varpar ljósi á annars vegar heilsufarsáhrif erfðabreytts maís sem víða er notað í fóður og matvæli og hinsvegar á alvarlegar brotalamir í leyfisveitingakerfi því sem notast er við í Evrópu, þ.á.m. hér á landi. Af þeim ástæðum er hér með skorað á stjórnvöld að stöðva leyfisveitingar til útiræktunar á erfðabreyttum plöntum hér á landi, þar til (a) fram hefur farið gagnger endurskoðun á regluverki leyfisveitinga og rannsóknarforsendum þeirra, og (b) vísindarannsóknir sem lagðar eru þeim til grundvallar hafa verið gerðar gegnsærri og óháðari hagsmunum líftæknifyrirtækja.

• Umrædd vísindarannsókn er fyrsta langtíma tilraun á dýrum sem sýnir heilsufarsáhrif neyslu erfðabreyttra afurða á heildar líftíma dýranna (tveimur árum), en ekki einvörðungu skammtíma (90 daga) dýratilraunir sem líftæknifyrirtæki (Monsanto, Syngenta o.fl.) leggja fram er þau sækja um leyfi til ESB.
• Rannsóknin var gerð af hæfum vísindamönnum sem eru óháðir sérhagsmunum fyrirtækja í líftækni, rannsóknarskýrsla þeirra var ritrýnd og birt í virtu alþjóðlegu vísindatímariti.
• Rannsóknin fjallar m.a. um áhrif neyslu erfðabreytts maís af yrki (NK603) sem ræktað er víða og notað – að öllum líkindum einnig hér á landi – til fóðrunar búfjár, svo og til vinnslu fjölmargra matvæla, og sumstaðar til beinnar neyslu manna.
• Niðurstöður benda til neikvæðra áhrifa af neyslu hins erfðabreytta yrkis á heilsufar, m.a. æxlismyndana, truflana á líkamsstarfsemi, tjóns á mikilvægum líffærum á borð við lifur og nýru, og ótímabærs dauða.
• Erfðabreytta maísyrkið NK603 er framleitt af fyrirtækinu Monsanto. Matvælaöryggisstofnun Evrópu (EFSA) samþykkti notkun þess í matvæli og fóður í Evrópu á árinu 2009 á grundvelli skammtíma (90 daga) tilrauna á rottum sem Monsanto sjálft gerði. (Monsanto hefur haldið gögnum um þær tilraunir leyndum.)
• Sama tegund af rottum var notuð í frönsku langtíma rannsókninni á NK603 maísyrkinu. Engan þarf að undra þótt EFSA telji frönsku rannsóknina ómarktæka: Ef EFSA viðurkenndi að rannsóknin hefði gildi væri stofnunin að viðurkenna að leyfisveiting hennar á sama maísyrki hefði verið röng og að allt leyfisveitingakerfi ESB sé þar af leiðandi meingallað.

Við hörmum órökstuddar ádeilur og óábyrg viðbrögð margra – þar á meðal íslenskra – vísindamanna við niðurstöðum þessarar rannsóknar, sem reyndar eru síður en svo þær fyrstu sem sýna fram á heilsufarstjón. Almannavaldinu ber að okkar áliti að bregðast við slíkum rannsóknum á grundvelli varúðarreglunnar og tryggja betur en gert er öryggi íslenskrar náttúru, neytenda og framleiðenda gagnvart hugsanlegri áhættu af völdum erfðabreyttra lífvera og afurða þeirra. Áskorun okkar er nánar útskýrð í meðfylgjandi greinargerð og fylgiskjölum.

Matvæla- og veitingafélag Íslands

Náttúrulækningafélag Íslands

Neytendasamtökin

Slow Food Reykjavík

Vottunarstofan Tún

Greinargerð:

Rannsókn Gilles-Eric Séralini o.fl. og viðbrögð vísindasamfélagsins1

Hópur sérfræðinga frá háskólunum í Caen í Frakklandi og Verona á Ítalíu, undir forystu Gilles-Eric Séralini, rannsakaði langtíma eitrunaráhrif erfðabreytts maísyrkis á tilraunarottur. Um er að ræða maísyrkið NK603 sem Monsanto framleiðir og er erfðabreytt til að þola illgresiseitrið Roundup. Fylgst var með rottunum allt æviskeið þeirra sem er um tvö ár. Könnuð voru áhrif þess að fóðra þær á NK603 maísyrkinu, með eða án viðbætts Roundup eiturs. Rannsóknirnar leiddu í ljós að kvenrottur í meðferðarhópum urðu fyrir tíðari og skjótari ótímabærum dauða, mynduðu mun oftar æxli í brjóstvöðvum, heiladingull varð oft óvirkur, og jafnvægi kynhormóna raskaðist. Karlrottur urðu margfalt oftar fyrir tjóni á lifur, alvarlegri nýrnabilun og myndun sýnilegra og stórra æxla. Hjá báðum kynjum komu fram viðvarandi nýrnavandamál. Vísindamennirnir telja að hin miklu og neikvæðu heilsufarsáhrif sem fram komu í rannsókninni skýrist annars vegar (1) af truflandi áhrifum Roundup illgresiseitursins á innkirtlastarfsemina og hinsvegar (2) af öflugri tjáningu hins erfðabreytta efnis í maísyrkinu og afleiðingum þess fyrir efnaskipti líkamans.2

Viðbrögð líftækniiðnaðarins við rannsóknarniðurstöðum
Skömmu eftir birtingu rannsóknarinnar hóf líftækniiðnaðurinn árás á aðferðir og niðurstöður hennar, og einnig á einstaka vísindamenn sem unnu rannsóknina og á stofnun sem margir þeirra starfa hjá (CRIIGEN). Gagnrýnin birtist einkum á vefsetri Science Media Centre (SMC) sem sendir fjölmiðlum upplýsingar um vísindaleg málefni. Þótt SMC telji sig sjálfstæðan aðila er meirihluti fjármögnunaraðila þess og meðlima tengdir stórfyrirtækjum sem mörg hver eru líftæknifyrirtæki. Hópur átta vísindamanna sem gagnrýndu rannsóknina harkalega á vefsetri SMC og telja sig sjálfstæða starfa hinsvegar fyrir líftæknifyrirtæki, eru handhafar styrkja frá stjórnvöldum og líftæknifyrirtækjum til að þróa erfðabreyttar plöntur, tengjast þrýstihópum fyrir erfðatækni á borð við International Life Sciences Institute eða hafa stofnað sín eigin líftæknifyrirtæki. (Viðauki 1: Átta vísindamenn og hagsmunatengsl þeirra.)

Rannsóknir hannaðar í þágu sérhagsmuna?
Séralini og félagar hafa verið sakaðir um að hanna rannsóknina til þess að kalla fram ákveðnar niðurstöður. Fjöldi vísindamanna í líftækni er háður líftæknifyrirtækjum um fjármagn og starfsöryggi. Setji þeir fram rannsóknir sem draga í efa öryggi erfðabreyttra afurða eiga þeir á hættu að missa störf sín og vera settir á svartan lista í atvinnugreininni. Sjálfstæðir vísindamenn búa síður við slíkar ógnir, enda byggjast störf þeirra og fjármögnun á því að ströngustu kröfum um vísindaleg vinnubrögð, fagmennsku og gegnsæi sé fullnægt. Það segir sína sögu að rannsókn Séralini o.fl. leiddi í ljós að erfðabreytta maísyrkið NK603 valdi tilraunarottum heilsutjóni, en tilraunir Monsanto á samskonar rottum fundu engin marktæk heilsufarsáhrif af neyslu sama maísyrkis. Þar sem hvorug rannsóknin er fullnægjandi sönnun á hvorn veginn sem er, þá er líklegra að dýratilraunir líftæknifyrirtækja séu hannaðar til að fá óskaniðurstöður frekar en rannsóknir sjálfstæðra vísindamanna.

1 Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize -

Food and Chemical Toxicology. (2012) http://dx.doi.org/10.1016/j.fct.2012.08.005.

2 Í samantekt (Abstract) um rannsóknina segir eftirfarandi (sjá ofangreinda tilvísun): The health effects of a Roundup-
tolerant genetically modified maize (from 11% in the diet), cultivated with or without Roundup, and Roundup alone (from 0.1 ppb in water), were studied 2 years in rats. In females, all treated groups died 2–3 times more than controls, and more rapidly. This difference was visible in 3 male groups fed GMOs. All results were hormone and sex dependent, and the pathological profiles were comparable. Females developed large mammary tumors almost always more often than and before controls, the pituitary was the second most disabled organ; the sex hormonal balance was modified by GMO and Roundup treatments. In treated males, liver congestions and necrosis were 2.5–5.5 times higher. This pathology was confirmed by optic and transmission electron microscopy. Marked and severe kidney nephropathies were also generally 1.3– 2.3 greater. Males presented 4 times more large palpable tumors than controls which occurred up to 600 days earlier. Biochemistry data confirmed very significant kidney chronic deficiencies; for all treatments and both sexes, 76% of the altered parameters were kidney related. These results can be explained by the non linear endocrine-disrupting effects of Roundup, but also by the overexpression of the transgene in the GMO and its metabolic consequences.

Opinberar leyfisveitingar verði endurskipulagðar
Franska rannsóknin sýnir þörf á að endurskipuleggja kerfi leyfisveitinga til ræktunar erfðabreyttra plantna og draga úr áhrifum líftæknifyrirtækja á þær. ESB veitir líftæknifyrirtækjum leyfi til ræktunar á grundvelli öryggisrannsókna sem gerðar eru af sömu fyrirtækjum og sækja um leyfin. Þetta eru skammtíma tilraunir á dýrum (einungis 90 daga) og aðferðirnar sem notaðar eru gera vísindamönnum kleift að dylja breytileika og frávik. Monsanto hefur notað hugtakið „historical norm“ til að gera lítið úr tölfræðilega marktækum niðurstöðum rannsóknar Séralini. Þá leyfist líftæknifyrirtækjunum að halda grunngögnum þessara dýratilrauna sinna leyndum.

Franski Evrópuþingamaðurinn Corinne Lepage sem stofnaði frönsku rannsóknarstofnunina CRIIGEN árið 1999 hefur krafist þess að öll rannsóknargögn verði gerð opinber. Hún hefur kallað eftir því að líftæknifyrirtæki á borð við Monsanto láti sjálfstæðum vísindamönnum í té fræ erfðabreyttra plantna sem þau hafa þróað til þess að þeir geti gert óháðar rannsóknir á öryggi þeirra. (Viðauki 2: Yfirlýsing Corinne Lepage um rannsókn Séralini o.fl.) Í samræmi við kröfur Lepage o.fl. um aukið gegnsæi í vísindum hefur CRIIGEN birt ítarleg svör við þeim fjölda gagnrýnisatriða sem beint hefur verið að rannsóknum Séralini o.fl. (Viðauki 3: Svör CRIIGEN við gagnrýni sem fram hefur komið.) Evrópusamtök vísindamanna um félagslega og umhverfislega ábyrgð hafa fagnað rannsókn Séralini, krafist ábyrgari umfjöllunar um hana og uppstokkunar á öryggismati leyfisveitinga. (Viðauki 4: Yfirlýsing ENSSER um skýrslu Séralini o.fl.)

Vísbendingar um vaxandi neikvæð áhrif erfðabreyttra matvæla á lýðheilsu
Fram til þessa hefur megnið af erfðabreyttum matvælum verið í formi unninna matvæla, en vinnsluferlar sundra mestu af DNA í erfðabreyttum hráefnum. Markmið líftækniiðnaðarins er hinsvegar að auka hlut ferskra erfðabreyttra matvæla í fæðuvali okkar, sem mundi gera neytendur berskjaldaða fyrir miklu magni af erfðabreyttu DNA. Suður Afríka er eina landið í heiminum þar sem leyft er að rækta grunnfæðu almennings í formi erfðabreytts yrkis. Suður Afríkubúar neyta nú erfðabreytts maís beint af ökrunum og – sem verra er – 40% af þessum maís er sama erfðabreytta yrkið (NK603) og notað var í rannsókn Séralini. Það er verulegt áhyggjuefni að líftækniiðnaðurinn sé að þróa erfðabreytt hveiti, hrísgrjón og kartöflur, sem allt eru grunnfæðutegundir sem neytt yrði beint af akrinum.

Franska rannsóknin gefur sterkar vísbendingar um hver áhrif erfðabreyttra matvæla kunni að verða á heilsufar manna sem neyta þeirra alla ævi: Því meir sem við neytum af erfðabreyttum matvælum (ýmist unnum og beint af akrinum) og því lengur sem við gerum það, þeim mun líklegra er að við verðum fyrir heilsutjóni sambærilegu því sem tilraunadýrin í rannsókn Séralini urðu fyrir.

Sjá nánar í viðaukum hér að neðan:

Viðauki 1: Átta vísindamenn og hagsmunatengsl þeirra.
Viðauki 2: Yfirlýsing Corinne Lepage, fulltrúa á Evrópuþinginu, um rannsókn Séralini.
Viðauki 3: Svör CRIIGEN við gagnrýni sem fram hefur komið á rannsókn Séralini o.fl.
Viðauki 4: Yfirlýsing ENSSER (European Network of Scientists for Social and Environmental Responsibility) um rannsóknarskýrslu Séralini o.fl.

Viðauki 1:

Átta vísindamenn og hagsmunatengsl þeirra

Hvað er Science Media Centre?

The Science Media Centre claims to be independent but the majority of its funders and members are large corporations many of which are connected to the biotech industry. This is not surprising given that the director, Fiona Fox, has extreme pro-GM, pro-cloning credentials. She is a former member of Revolutionary Communist Party, a cultish group, which sounds in name to be left wing but which, in fact, is extremely right wing. She was a contributor to its magazine, Living Marxism, and is a current contributor to Spiked, a website set up by former members of the RCP. It is unclear what the ultimate aim of this group is, but they seek power through science. They are supportive of Monsanto, Syngenta and the biotech industry‘s global lobby group, Crop Life International, while being overtly hostile to their critics.

Átta vísindamenn og árás þeirra á rannsóknir Séralini

Eight scientists have attacked the Seralini study via the website of the Science Media Centre, an organisation which acts as a press office for science and which claims to be independent while being funded by large corporate interest groups. Seven of the eight scientists which posted their criticisms on SMC did so without mentioning their professional and/or financial interests in GM biotech industy.

Professor Maurice Moloney, Director, Rothamsted Research Institute
Professor Moloney provided the research behind Monsanto‘s GM canola and has launched his own GM company. He drives a Porsche car with a number plate „GMO“.

Dr. Wendy Harwood, senior scientist, John Innes Centre
The John Innes Centre has received millions of pounds from the UK government and GM giants like Syngenta to carry out development of new GM crop types.

Professor Anthony Trewavas, Cell Biology, University of Edinburgh
Professor Trewavas is a GM crop scientists, a fervent opponent of organic farming and is notorious for his attacks on independent scientists who publish research critical of GM.

Professor Ottoline Leyser, Assistant Director of Sainsbury Laboratory, University of CambridgeProfessor Leysler ́s laboratory is funded by the Gatsby Foundation of Lord (David) Sainsbury. Sainsbury is a GM enthusiast and biotech entrepreneur who also set up the funds for the GM-related work of the Sainsbury Laboratory at the John Innes Centre (see above).

Professor Tom Sanders, Head of the Nutritional Sciences Research Division, Kings College, London
Professor Sanders has defended the safety of the controversial artificial sweetener Aspartame (NutraSweet) – a Monsanto owned company. He has stated that liquidised fresh fruit juice compares unfavourably to drinking Coca-Cola, and has made many spurious comments about other scientists ́ work.

Professor Mark Tester, Australian Centre for Plant Functional Genomics, University of Adelaide
The University Adelaide profiles Professor Tester as follows: „His commercial acumen is clear from his estalishment of private companies and successful interactions with multinational companies such as Monsanto, Syngenta, Bayer and DuPont Pioneer.“

Professor Alan Boobis, Professor of Biochemical Pharmacology, Imperial College, London
Professor Boobis is a long time member of the EFSA, the body which approved the GM maize tested in Seralini‘s study. He is on the board of the International Life Sciences Institute – which is a biotech and food industry lobby group whose backers include GM giants BASF, Bayer and Monsanto.

Viðauki 2:

Yfirlýsing Corinne Lepage, fulltrúa á Evrópuþinginu, um rannsókn Séralini.

Corinne Lepage MEP on why the Seralini study is "a bomb"
Tuesday, 25 September 2012

Admittedly, I am biased. I founded CRIIGEN in 1999 because I needed to know. My government experience gave me serious doubts about GMOs. My scepticism was shared by the Prime Minister Alain Juppe, who had signed a moratorium on GMOs in 1997. Subsequently, as President of CRIIGEN, I wanted, followed, and supported the study by Professor Gilles-Eric Seralini on NK603 maize.

I shall reply very briefly, though I am not a scientist, to the criticism that is proliferating about this study, largely emanating from scientists working for biotechnology firms or who are responsible for the lax manner in which approvals have been granted. The two are not incompatible.

Some critiques, including one published in this journal [weblink] - come from very respectable people who know nothing about the context of GMOs and the conditions in which the studies that underlie authorisations for the consumption of these products are carried out. I want to reply, so as not to be accused of kicking these arguments into touch, although in my view they miss the point.

The first critiques are on the methodology: This study is a toxicological and not a feeding study. This means that studies of pathology and blood and urine tests were performed, which is not the case in the second type of study.

"The strain of rats selected is not appropriate" ... Interesting critique when you know it is the same strain as that used by Monsanto in its studies, which served as a basis for authorisations issued in Europe. If this strain is not valid then all authorisations must be withdrawn as they are based on ineffective tests.

"The number of animals tested per group were insufficient" ... Except that no study has ever been conducted on as many animals (200) and the number of rats per group (10 [in Seralini's case, it was 10 of each sex]) is the same as the number used in all studies submitted to public bodies and validated by them [GMW comment: Monsanto used 20 rats per group in its 90-day study on NK603 but reportedly only analysed 10! See: de Vendomois, J. S., F. Roullier, et al. (2009). A comparison of the effects of three GM corn varieties on mammalian health. Int J Biol Sci 5(7): 706–726. So Lepage is correct in saying that no industry tests on a GMO submitted for approval have analysed more than 10 rats per group]. Consequently if that number does not allow conclusions to be drawn, then none of the studies that served for GMO authorisations could be taken into account either.

Why pioneer different tests on rats, isolating the GMO from the Roundup herbicide, at the risk of prompting confused criticisms from some people who don't understand the topic? Indeed, this experiment involved rats that consumed GM NK603 maize which had not been treated with Roundup (the pesticide that this corn tolerates, which means it can be sprayed with industrial quantities without being destroyed); rats treated with Roundup at three different dose levels; rats that consumed only Roundup; and rats fed a GM-free diet without Roundup. This was simply to investigate whether the abnormalities found in rats consuming GM were due to Roundup or whether the GM maize was toxic in itself.

Finally, the maize under examination was resistant to the pesticide Roundup (the case with 80% of current GMOs). It was not a Bt maize producing its own pesticide, on which independent and long-term studies are yet to be done.

The second criticism says that the results are not conclusive. I leave it to the authors of the study to reply on the CRIIGEN website. I will simply say that it is clear that at the end of the experiment all rats died because the experiment covered the full lifespan of rats, in order to gain information on the effects of GMOs eaten over a human lifetime. However, it is clear that the number of tumours and mortality happened sooner [in treated groups]. Tumours appeared in greater numbers in rats fed GMOs and/or exposed to Roundup. A tumour mass of 25% of bodyweight leads to euthanasia to prevent animal suffering. Mortality was higher in treated rats as compared with controls.

The third criticism, of bad faith, relates to the personality of Professor Seralini and the secrecy surrounding the study and its media release. Ad hominem attacks are a constant factor with regard to all whistleblowers. Regarding Professor Seralini, who enjoys an international reputation, we simply highlight that Marc Fellous was found guilty of defamation on January 18 2011 [in a libel case], after he said that Seralini claimed to be
independent while his studies were funded by Greenpeace. It is easier to understand in this context, then, why the same person and his association criticized the study constantly on the airwaves and in the press.

Secrecy was imperative both because publication in a major international scientific journal requires a total absence of communication prior to publication and because the power of Monsanto and its allies is such that a leak would have destroyed any hope of completing the study.

Finally, with regard to the media release, it was powerful because it was a first. Usually, the power of the media is on the side of advertisers - Monsanto and those who work for the company, or its smaller competitors. It was perfectly justifiable that an operation of this magnitude was accompanied by a film, two books, and several documentaries translated into five languages and distributed free on the Internet.

I wanted to respond to these criticisms to show their weakness, but they clearly miss the point. The real questions raised by this study do not directly concern the study. They remain, whatever criticisms are levelled against it.
Why has a study of this nature never been done before? Contrary to misinformation, no toxicity studies on rats fed over two years - that is to say, over their expected lifetime, equivalent to a human lifetime - have ever been performed. Moreover, Gerard Pascal, a former toxicologist and specialist on GMOs at the National Institute of Agronomic Research (INRA), and now a consultant to food companies, recognizes this. In this affair, he is partly responsible, being involved in the biomolecular engineering commission in charge of dossiers that resulted in authorisations.

Why has the GMO debate focused on contamination and cultivation, completely obscuring the health issue? That GMOs would have no effect on human health was asserted as a dogma, even though not a single long- term study provided evidence for such a statement. So how should we understand the opposition of the Director of EFSA [Geslain-Laneelle] in the hearing before the Committee on Health and Environment of the European Parliament on September 20 to the proposal that further studies be conducted over two years?

Why have public expert bodies, including the CGB and AFSSA in France (though ANSES seems to want to change the rules of the game) and EFSA at the European level, not only tolerated but validated 90-day studies such as that on NK60, which showed statistically significant effects - and refused to admit that they were of any pathological consequence? The two-year study by Professor Seralini shows that 90-day studies may not show anything since the first tumours only appeared in the fourth and fifth months.

Why do these same organizations continue to ignore the effect of low doses even though numerous studies have shown that this is a futile exercise? And do they accept the fact that differences between males and females have not led to systematic research on hormonal effects?

All these questions arise regardless of the criticisms against the study and Professor Seralini. They cast into question the quality of the studies that led to authorisations, as well as the motives of the experts who validated them.

In particular, the complaint that Professor Seralini is biased and non-independent is especially surprising since these same experts are not at all troubled by the fact that the studies that are presented to them are all done by laboratories funded directly by the [industry] applicants.

In fact, this study is a bomb, for four reasons.
1. It circumvented Monsanto's ban on using its seed for research purposes, which was intended precisely to prevent such independent studies being carried out.
2. Professor Seralini is committed to making public his raw data so that there is a real scientific debate, but only when producers of GMOs and public authorities respect the law and abandon the secrecy behind which they hide their own knowledge by making their raw data public too.
3. The study highlights the weakness of the studies that led to the marketing of GMOs and demonstrates the laxity of experts and government authorities: they could be liable.
4. The accusation of secrecy levelled at critics of GMOs precisely describes the accusers, who did everything to make it impossible to carry out a study such as the one performed by CRIIGEN.

Therefore, the best solution for those responsible for this situation is not to open a real scientific debate about the toxicity of GMOs, but to prevent this debate by discrediting the study and its author. Since 1896, when the first report appeared that put into question the harmfulness of asbestos, the strategy of the manufacturers of products that give rise to health and environmental scandals has always been the same, with effects on the population and social security figures that we know all too well. The time for change has come. The scientific debate must be liberated from this type of religious war into which the major lobbies have locked their opponents.
As an MEP representing 450 million European consumers, I cannot accept such a situation. The subject is too important not to be examined objectively, independently of economic interests, and in the interests of the health and life of Europeans, and more broadly of all humankind.

Finally, I wish to pay tribute to all those who contributed to this study. Those in civil society, who are not extremists and who just want honest and independent answers to their questions.

Viðauki 3:

Svör CRIIGEN við gagnrýni sem fram hefur komið á rannsókn Séralini o.fl.

SECTION ONE : PROTOCOL

Why not use a varied "reference" food on top of your controls, as did Monsanto?
In science we study one variable at a time. We can thus only seriously compare to a genetically similar control shown to be substantially equivalent to precisely study the GMO effect.

Why not have used a standard statistical method?
These methods have not been judged satisfactory by expert agencies to demonstrate toxicity for groups of 10 rats. However, the maximum differences for deaths or tumors with controls (600 days, 2-5 times more) speak for themselves.

In addition, there is an underestimation of the tumorigenic effects at the end of two years compared to controls according to these curves data. This underestimation is due to the fact that the controls are living longer and developing pathologies, including tumors, towards the end of life.

What degree of confidence is there in the significant differences found by the statistical method OPLS-DA, there is no p-values?
This is one of the most modern methods to treat a large number of variables, such as in genomics, indeed the significance does not pass through the p-value reserved for other tests.

Why have you shown biochemical analysis at month 15?
We could not put everything in a first article. This is the last time point when there are the most live rats, which demonstrates significance.

Were the rats treated during the experiment by other molecules? Sanitizers? Antibiotics?
No. Not with GLP (Good Laboratory Practice) in general, otherwise they are excluded from the experiment.

Why were you using two different formulations of Roundup (with crops and contaminated water)?
The formulations contain about 500 g / L of glyphosate. They have different names in different countries.

Where did you grow the maize and treated the rats?
We used maize from Canada because the culture of this GMO is permitted in Canada, unlike in France. Rats were under experiment in France and analysis was performed in different laboratories, some wish to remain anonymous, in France and Italy.
Proponents of this type of study are generally industrial companies and the fact that a NGO and a university developed this study together means that it is independent and unique.

Is the maize used as a control exactly the same as the GMO?
A genetic identity is not possible given the method of seed production but it is the closest genetically and phenotypically.

Were the different maize grown at the same time? Were the climatic conditions the same?
Absolutely yes, and geographically very close, avoiding cross contamination though.

How many times have the maize been treated? At what time?
Once during the culture by the Roundup, when treated. Residues of glyphosate and AMPA in GMOs are recognized and regulated, even in the tissues of animals consuming them. Waivers for overruns are regularly granted, unfortunately. This was not the case for us.

Was there glyphosate in the controls' water?
Not within the limits of detection. We changed the water weekly and contaminated it with the precise doses
indicated for treatments.

Why did you use an average and not a median for the aging limit?
It is the general custom; there is little talk of the median life of the French for example. We have not drawn from it any statistical calculations but a graphic mark.

SECTION TWO : THE RESULTS

What is the magnitude of the difference in mortality of the controls compared to the historical norm?
Each experiment having its own conditions, the historical norm is too large to be a relevant comparator. The controls are in the average normal life, and our differences are compared to the controls of the experiment.

How do you explain the absence of manifestation of biochemical disturbances in the males?
On the opposite, there are many. However, all the results are not presented in the study, it was impossible because of their number. There is always a time difference between biochemical disturbances, the firsts to appear, and pathological lesions that we observe in both sexes. In the males the pathological lesions were earlier and larger than in the females and these lesions are the most noticed.

The same differences can be found in all treatments, how do you know that your controls are not the abnormal ones? Or that it is not due to luck?
Our controls correspond to the values observed in the species. Pathological findings have logical explanations for all treatments, they are consistent and numerous enough to not be related to chance; extensive statistics at the biochemical level are consistent and show it. Our in vitro studies are consistent.

How can you be sure that such a little depletion in ferulic and caffeic acids also explains a wide range of pathologies?
There are for us understandable indicators of the changes in the metabolism of the maize that could have happened, the very interesting logical tracks from the scientific literature and our work, they in no way exclude the action of other metabolites toxic due to the GMO and that is why we are asking for funding for analysis in proteomics, transcriptomics, in order to know the events' mechanistic key details.

Do you have any interesting results for the doses of Roundup in the tissues, microbiology and transgene dosing?
Yes we have results that must be completed that give us very interesting leads that will be published later. Several publications are planned after this preliminary work.

Why use the threshold of 17.5 * 17.5 mm in males and 20 * 20 mm in females to count tumors?
Because it is the threshold size at which more than 95% of tumors are non-regressive.

What is the basis for determining the pathogenicity criteria used in Table 2? What classification do you use?
By differential elimination of the smallest gaps.

Have you measured glyphosate residues in the NK603 or the dry food?
Yes we checked its use and the presence of all pesticides. Values were below regulatory thresholds. The limits of quantification in the different matrices are different.

You indicate an effect on oxidative stress in rats due to your treatments, are the oxidative stress markers disrupted?
Yes for the cytochromes in the liver, and the GST for instance.

Have the maize been sprayed with other pesticides? Have you found other residues?
Yes, normally, they were not organic crops that we could test thereafter. There are no pesticides above the threshold of quantification in food.

SECTION THREE : DISCUSSION

Are the results that you find in this study corresponding to disturbances found in the subchronic tests reanalyzed previously in your publications, that Monsanto sub-interpreted?
Yes, there are signs of hepatorenal toxicity that were published previously after only 90 days of treatment, which are reported as pathologies firmly in our long-term experience.

Do you think that these pathologies may be transferable to humans?
Very generally, yes, but not all. In fact, any signs of toxicity in rats must be taken into account for the prohibition of a product. For 50 years the studies are performed in rat or human cells for products that are not tested in humans (where they test only drugs, not GMOs, nor pesticides nor chemicals). And for drugs, tests on rats or 2-3 mammals precede any clinical trial. If they show serious effects, humans are not treated then. Hormonal disturbances are certainly relevant for women to contribute to breast tumors and hepatorenal effects were found in vitro on human cells.

Why do you quote Zhang et al. 2012 as a reference? This reference concerns on no account GMOs.
One hypothesis is that new micro RNA produced by GMOs may interfere with the metabolism. We could not leave it untold, but we have other explanatory hypotheses.
How do you explain that the reported effects are not found in the human populations? Nobody has ever noticed an increase in breast cancer in the populations exposed to Roundup?
There is an explosion in the number of breast tumors that are not explained by epidemiological studies. We remind you that GMOs not being labeled, the GMO consumption in the U.S. is not listed, nor for the use of Roundup all around the world.

It is recommended to experiment on 50 rats for a statutory study on carcinogenesis. What value to bring to your results on 10 rats? We studied 200 rats, 10 rats/group. Statutory biochemical studies are recommended by the OECD on 10 rats per group minimum.
No statutory study which allowed the authorization of GMOs had more than 10 rats measured per group.
We therefore made the most robust tests in the world, especially as we were examining the long term.
We could not anticipate the results of the tumors, but we observed and recorded them in this study, what was normal, it is not the study of specific carcinogenesis effects with 50 rats/group that would not have allowed to observe the hepatorenal effects and others.

Are the concentrations of ferulic acid found correspond to those indicated in the experiment of Monsanto?
Monsanto has unfortunately not measured the concentrations of hepato-renal and mammo-protective acids directly in the diet, but only once ferulic acid in maize and GMO control.

You say that 76% of the parameters are perturbed in the kidney, in what does that show toxicity? I do not understand this method.
We record all parameters disturbed compared to controls and compare them to the number of parameters related to renal activity over the set of all parameters. We have 48% of renal parameters amongst all measured parameters, yet 76% of the disturbed ones are markers of renal activity! Any doctor would panic for a patient in this case. Distribution cannot be due to chance. (This figure was 42% in one of our previous publications, of disturbed parameters, for 24.9% measured in the male kidney and for a quarterly consumption on average of 19 GMO, testing regulations). The kidney is 1.5 times more affected than other organs.

Roundup increases lifespan in males? Isn't this the best indicator of the safety of this herbicide? This increase is even dose-dependent. Strangely you do not talk about it, why?
We leave you this misinterpretation! Treated males were sicker than controls in all cases, even if in one case out of 6 treatments (3 males + 3 females) there was no extra mortality at any dose before average life expectancy. These rats lose weight however (discussed in another publication) and this can give them some resistance.

Have you compared your results with those of the Japanese study of Sakamoto or another? Contrary to what you say you're not the first to study the safety of one GMO for 2 years.
Yes. None has been as comprehensive as ours, and none is on the maize NK 603 beyond 3 months.

Why did you choose Sprague Dawley rats?
This is the most common model in these studies, the best known.

You've done the study in a GLP environment, is the study GLP? Doesn't the fact that it is not undermine it?
There was no standard protocol for this type of very long study with GMO, we establish it while improving it. This is a world first. Thus there could not be any pre-established standard for this type of test. In addition, this research is a protocol where we added analysis along, biochemical and microscopic to understand what was happening. Now it may serve as an example to establish standards for GLP for GMO, much more serious than what the health agencies do today who do work neither scientifically nor honestly. However, we did that in a GLP lab environment, of course.

Produced by the Team of Prof. Séralini.

Viðauki 4:
Yfirlýsing ENSSER (European Network of Scientists for Social and Environmental Responsibility) um rannsóknarskýrslu Séralini o.fl.

Sjá pdf-skjal:
www.ensser.org/fileadmin/files/ENSSER-Comments-Seralini-etal2012.pdf.

Ljósmynd: Bygg úr eigin ræktun, Guðrún A. Tryggadóttir.