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Letter

The European Union (EU) Direc-tive 90/220/EEC concerning

the deliberate release of geneticallymodified organisms (GMOs) into theenvironment was published in 1990,and was implemented from 1992 to1995 in all 15 EU member states.Recently, members of the EuropeanParliament in Strasbourg voted onthe proposed amendments to thislegislation. These amendments werecontained within the co-decisionprocedure’s second stage readingpresented on 12 April 2000 (Ref. 1).

A failed Directive?Originally, the harmonization of

procedures and the criteria forbiosafety assessment were the mainaims of the Directive, under the concept of the EU single market.The regulation was ‘process based’,in contrast to the ‘product based’regulation in the USA. The Direc-tive 90/220/EEC is divided intothree main sections: (A) definitionsand provisions of the directive, (B)experimental release and (C) productrelease, on a commercial basis, to themarket2.

Since the Directive was imple-mented, its primary goal of harmon-ization has failed. Serious differencesbetween the member states on thetopic of GMOs (namely GM crops)have arisen because of differing con-cepts of risk, cultural and historicalelements, and ‘biopolitics’.

Biopolitics definedBiopolitics is a catch phrase defined

as the politicization of modernbiotechnology issues within thepolitical stream, which can influencepublic policy at local, national andinternational levels.

The concept of the ‘political stream’is derived from John Kingdon’s studyof agenda setting3 where the el-ements of this stream include:

(1) national mood: public opinion,climate of opinion and mass media;

(2) organized political forces:political parties, pressure groups and lobbyists;

(3) consensus-building: band-wagonsand bargaining; and

(4) government: changes in power,elections and personnel changes.

An example of the role of bio-politics in influencing public policy is embodied in the evolutionary pathway of Directive 90/220/EEC.There have been no new GMOapprovals since April 1998. To date,there have been 18 GMOs approvedfor commercial use and four are await-ing approval. However, on 20 May1999, the EU commission said that it would delay the approval of allpending requests as a result of con-cerns raised by the Monarch butterflystudy at Cornell University (Ithaca,USA)4.

Ministerial declarations:biopolitical posturing

In June 1999, the Council of Ministers met for a marathon 20-hour session in Luxembourg to discuss the topic of GMOs. Before the meeting, European politics hadbecome intensified because of theEU Parliamentary elections that weretaking place throughout the memberstates at the time. As a result of extensive media reporting of theArphads Pusztai rat experiments5 andthe effects of Bt pollen on monarchbutterflies4, GM crops were a topicthat most candidates faced on thecampaign trail. At the Council meet-ing, there was a French-sponsoreddeclaration calling for a moratoriumon GMO approvals. A BritishDepartment of Environment spokes-woman accused the French of play-ing politics with the issue. She wascited as saying ‘The French Ministermade it clear there was no legal basisfor a blanket moratorium. What theywere putting forward was a politicaldeclaration’. In essence, the Frenchposition was purely biopolitical posturing.

During the meeting, it emergedthat there were actually two substan-tial, separate declarations. The firststatement asked the Commission to‘...without delay, draft rules ensuringlabelling and tractability of GMOsand GMO-derived products andstate that, pending the adoption ofsuch rules, in accordance with pre-ventive and precautionary principles,they will take steps to have any newauthorizations to allow for growingand placing on the market suspended’.

Signatories included France, Greece,Italy, Denmark and Luxembourg.

The second declaration requestedthe EU to ensure that it would ‘...notauthorize the placing on the marketof any GMOs until it is demonstratedthat there is no adverse effect on theenvironment and human health...’ .This was signed by Austria, Belgium,Finland, Sweden, Germany, Spainand The Netherlands. Interestingly,Britain, Ireland and Portugal did notsign any of the above declarations.Eventually, the Environment Minis-ters agreed that there was no legalbasis for a moratorium. They alsoagreed on proposals that included: • post-marketing monitoring of GM

crops;• new risk-assessment rules;• phasing out of the use of antibiotic

marker genes;• formal bioethics studies;• examination of the liability clause;

and• increased public input and infor-

mation.The meeting proved to be an indi-

cator of the political division withinthe EU, whose member states aresupposed to emulate the concept ofa single market.

Current difficultiesNot only were there divisions

between member states, but alsothere were considerable differenceson the issue between the ‘pillars’ ofthe EU, namely the Council, theEuropean Parliament and the Euro-pean Commission. This has beenclearly proven again in a recentspeech by the EU EnvironmentCommissioner, Margot Wallstrom(at the previously mentioned Euro-pean Parliament discussion in April2000), where she stated that of the 52 amendments proposed in the second reading, the commission wasto reject 32, accept 15 in principleand only accept five outright. How-ever, it should be noted that the Par-liament only actually voted to adopt29 amendments, which then left thecommission in the position of reject-ing 16, accepting nine in principaland only accepting four outright.

Commissioner Wallstrom’s speechto the Parliament also showed strongevidence of biopolitics in action. Inrelation to the proposed amendmentspertaining to the use of antibioticresistance marker genes she stated, ‘Iam also fully aware of the politicalimportance of certain other aspects

Evolving European GM regulation:an example of biopolitics at work

raised by the proposed amendments.It is clear that antibiotic marker genes need to be phased out and bereplaced with alternatives as soon aspractically possible. A phase-out isalready foreseen in the common position. The commission agrees tostrengthen this political message’.

Yet she further compounded thebelief that the EU are attempting abiopolitical compromise by simulta-neously operating a public attitudeagenda and a scientific agenda whenshe added, ‘At the moment, there isno scientific evidence that all GMOsof this type (ie. containing antibioticresistance marker genes) presentadverse effects to human health andthe environment. Instead we shouldcontinue to carry out a comprehensivecase-by-case risk analysis’.

The Parliament was also dividedon some key amendments. It votedthrough 29 of the 52 proposedamendments to the common pos-ition on the proposals. It was decidedthat the year 2005 should be the definite date for the phasing out ofGMOs that contain antibiotic resist-ance marker genes rather than simplyphasing them out ‘progressively’.However, the amendments thatwould have banned such GMOsimmediately were rejected.

On the topic of legal liability forthe release of GMOs, the Parliamentrejected the proposal that the partylegally responsible for a deliberate

release be bearers of the cost of anydamage caused. However, the Com-missioner did assure to do her utmostto present a proposal for legislationon liability before the end of 2001.She also drew attention to the factthat the Commission has adopted a‘white paper’ on environment liabil-ity that included particular referenceto GMOs. The Commission holdsthe opinion that, in general, a hori-zontal approach is the most efficientway of guaranteeing a comprehen-sive responsibility regime for envi-ronmental damage. It is interesting tonote that the Commission indicatedthat it would reject outright a total of16 amendments, which the Parliamenthad voted to adopt.

The amended common positionwill now proceed to further discus-sions with the Council of Ministersand the Commission, where the pos-ition of Parliament will be addressed.When this occurs, agreed amend-ments will be applied to the regu-lations. Alternatively, if disagreementbetween the pillars of the EU stillremains, the process will enter a 6–8month conciliation procedure.

ConclusionThe emergence of biopolitics has

shown its effects at all levels. Whetherit has been the local banning of GMfood from school dinners by localcouncils in the UK, the failure ofnational governments such as Greece

or Austria to pay due regard to Euro-pean law, or even the internationalpolitical effects of global trade. Itseems that the public perceptions ofmodern biotechnology are having aneffect on the public policy process,which in turn is causing shifts in theregulatory guidelines. The vehiclefor this change has been, and willcontinue to be, biopolitics.

Shane Morris and Catherine Adley

S. Morris and C. Adley are at the Irish Biotechnology Information Centre, Department of

Chemical and Environmental Sciences, University of Limerick, Ireland.

(E-mail: shane.morris@ul.ie)

References1 Session Document A5-0083 (2000) Rec-

ommendation for second reading on theCouncil common position for adopting aEuropean Parliament and Council Direc-tive on the deliberate release into the environment of genetically modifiedorganisms and repealing Council Directive90/220/EEC

2 Lunel, J. (1995) Biotechnology regulationsand guidelines in Europe. Curr. Opin.Biotechnol. 6, 267–272

3 Kingdon, J.W. (1995) Agendas, Alternativesand Public Policies (2nd edn), HarperCollins

4 Losey, J.E. et al. (1999) Transgenic pollenharms monarch larvae. Nature 399, 214

5 Ewen, S.W. and Pusztai, A. (1999) Effectof diets containing genetically modifiedpotatoes expressing Galanthus nivalis lectinon rat small intestine. Lancet 354, 1353–1354

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Retrotransposons are mobile gen-etic elements that transpose via

the reverse transcription of an RNAintermediate. They are ubiquitous inplants, and play a major role in plantgene and genome evolution. In manycases, retrotransposons comprise over50% of nuclear DNA content, a situation that can only arise after several million years1. For example,retrotransposon PREM-2 comprisesapproximately 5% of the maizegenome2. However, the underlyingmechanisms by which plant genomeshave evolved to utilize retrotrans-poson sequences are only just begin-ning to be understood.

Retrotransposons containing longterminal repeats (LTRs) have manyof the attributes of retroviruses inanimals. The ability of retrotrans-posons to acquire a portion of a cellular gene, similar to RNA tumorviruses with oncogenes, could explainthe homology to plasma membraneproton ATPase genes within the Bs1 retrotransposon of maize3. Simi-larly, partial sequences of PREM-2,found exactly in the same positionupstream of three polygalacturonasegenes, suggest the possibility of an ancestral transduction of thesegenes by the PREM-2 element inmaize2.

There are several potential mecha-nisms for sequence acquisitions, forexample, by ectopic gene conver-sions or by recombination betweenan mRNA-derived template and the retrotransposon within the repli-cation and integration complex1.Similar sequence acquisitions couldresult from the insertion of recombi-nant DNA by particle accelerationtechnology or Agrobacterium tumefa-ciens-mediated transformation whenconstructing genetically modified(GM) plants. Indeed, the 39 end ofthe recombinant DNA insert in theGM-maize line GA21 is flanked bysequences of a truncated PREM2-retrotransposon (Fig. 1).

Molecular geneticcharacterization

GM-maize line GA21 was producedby particle acceleration technology

Recombinant DNA insertion intoplant retrotransposons

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