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26<br />

Approval <strong>of</strong> Bt11 Maize Endangers<br />

Humans and Lives<strong>to</strong>ck<br />

Dr. Mae-Wan Ho explains why the European Commission's decision<br />

<strong>to</strong> approve Syngenta's GM maize is illegal and criminal based on<br />

existing scientific evidence.<br />

<strong>The</strong> European Commission ended<br />

6 years <strong>of</strong> de fac<strong>to</strong> mora<strong>to</strong>rium on<br />

GM authorization by approving<br />

Syngenta's Bt11 sweet corn for<br />

food use in Europe on 19 May<br />

2004 (see Box 1). That, despite<br />

the fact that voting by experts last<br />

December in the EU's Standing<br />

Committee on Food Chain and<br />

Animal Health was an even 6-6<br />

country split with three abstentions.<br />

Finland, Sweden, Ireland,<br />

UK, Netherlands, and Spain voted<br />

in favour; Greece, Denmark,<br />

France, Austria, Luxembourg,<br />

Portugal voted against; and<br />

Belgium, Italy and Germany<br />

abstained. <strong>The</strong> same split happened<br />

at the Council <strong>of</strong> Ministers<br />

on 27 April, but this time Italy<br />

voted in favour, while Spain<br />

abstained.<br />

Belgium's scientists first<br />

expressed concerns over the<br />

safety <strong>of</strong> Bt11 when they subjected<br />

Bt11 <strong>to</strong> molecular characteri-<br />

Box 1<br />

His<strong>to</strong>ry <strong>of</strong> Bt11 maize approval<br />

An <strong>of</strong>ficial dossier was submitted <strong>to</strong> the European Union in 1996 and<br />

approved under the old Directive for deliberate release in<strong>to</strong> the environment<br />

(90/220/EEC) for import and processing since 22 April 1998.<br />

Two notifications for cultivation were submitted in 1996 (<strong>to</strong> France)<br />

and 1998 (<strong>to</strong> Spain). <strong>The</strong> Scientific Committee on Plants (SCP) gave a<br />

favourable opinion for these two notifications, although Syngenta has<br />

since withdrawn the latter. <strong>The</strong> 1996 notification was updated in 1998<br />

and 2002, and finally in 2003, additional information was supplied as<br />

required by the new Directive for deliberate release 2001/18/EC. <strong>The</strong><br />

French competent authority concluded that, in this respect, Bt11 "does<br />

not present a greater risk <strong>to</strong> human health or the environment than any<br />

other variety <strong>of</strong> maize". Approval <strong>of</strong> the application, which includes<br />

import, cultivation and all other uses, is still pending.<br />

<strong>In</strong> February 1999, a request was submitted under Regulation (EC)<br />

258/97 for placing sweet corn from GM maize line Bt11 on the market<br />

for food use (fresh or processed). On 17 April 2002, the Scientific<br />

Committee on Food gave its opinion that Bt11 sweet corn is as safe for<br />

human food use as its conventional counterparts.<br />

<strong>The</strong> vote in the Standing Committee on Food Chain and Animal<br />

Health, December 2003, resulted in an even 6-6 country split with<br />

three abstentions. A similar split ratio in the Council <strong>of</strong> Ministers 27<br />

April 2004 led <strong>to</strong> a stalemate. <strong>The</strong> European Commission broke the<br />

deadlock by deciding in favour <strong>of</strong> approval.<br />

sation, as required by Europe's<br />

current Directive for deliberate<br />

release. <strong>The</strong>se concerns were<br />

strongly reinforced by French and<br />

Austrian scientists.<br />

According <strong>to</strong> an article in Le<br />

Monde published 24 April, two<br />

scientific evaluation committees,<br />

in France and Belgium, had<br />

refused <strong>to</strong> give their approval for<br />

food use <strong>of</strong> Bt11 sweet corn. On<br />

22 April, AFSSA (French Agency<br />

<strong>of</strong> Food Sanitary Security)<br />

opposed the authorization <strong>of</strong> Bt11<br />

sweet corn for the third time, after<br />

having refused it twice before, in<br />

2000 and 2003, on grounds that<br />

the scientific results were insufficient.<br />

<strong>In</strong> a brief note published 22<br />

April, implicitly replying <strong>to</strong> the<br />

European Commission statement<br />

on 5 February that "the results<br />

supplied by Syngenta…are in<br />

accordance with the criteria and<br />

rules defined in the recommendation<br />

618/97/EC", AFSSA said it<br />

"maintains its previous opinion<br />

which concluded that <strong>to</strong> rigorously<br />

evaluate the impact <strong>of</strong> regular<br />

consumption <strong>of</strong> a maize carrying<br />

the Bt11 event, <strong>to</strong>xicity/<strong>to</strong>lerance<br />

experiments on rats must be carried<br />

out… Such <strong>to</strong>xicity/<strong>to</strong>lerance<br />

experiments are not required by<br />

the actual regulation, though they<br />

might be advisable … because<br />

the sweet corn is the only one <strong>to</strong><br />

be consumed by humans."<br />

<strong>The</strong> Belgian Council for<br />

Biosafety had already refused <strong>to</strong><br />

give its approval for the Bt11<br />

maize on 1 April 2004.<br />

Dr. Mae-Wan Ho and Pr<strong>of</strong>. Joe<br />

Cummins from ISIS and the ISP<br />

(<strong>In</strong>dependent <strong>Science</strong> Panel)<br />

have objected strongly <strong>to</strong> the<br />

approval <strong>of</strong> a range <strong>of</strong> GM crops;<br />

and called for the withdrawal <strong>of</strong><br />

approval already granted, most<br />

probably for the same reasons as<br />

the Belgian and French scientists:<br />

the GM inserts in all these crops<br />

were found <strong>to</strong> have rearranged<br />

since characterised by the company.<br />

That is a sign that the GM<br />

varieties are unstable, and hence<br />

contrary <strong>to</strong> requirement laid down<br />

by the current European Directive<br />

for deliberate release<br />

(2001/18/EC). Furthermore, there<br />

is evidence that some GM varieties<br />

are non-uniform, also contrary<br />

<strong>to</strong> the requirement <strong>of</strong> the<br />

current European Directive. Thus,<br />

the European Commission is contravening<br />

its own laws in approving<br />

Bt11.<br />

Ho and Cummins have referred<br />

<strong>to</strong> this as both "illegal and criminal";<br />

criminal because transgenic<br />

instability is a key safety issue,<br />

and there is already evidence<br />

suggesting that GM food and <strong>feed</strong><br />

are far from safe, even though<br />

very few <strong>feed</strong>ing trials have been<br />

carried out, and <strong>to</strong>xicological<br />

tests on natural Bt <strong>to</strong>xins are thoroughly<br />

inadequate <strong>to</strong> predict the<br />

much altered GM <strong>to</strong>xins incorpo-<br />

GM sweet corn anyone?<br />

SCIENCE IN SOCIETY 23, AUTUMN 2004

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