Dario Bevilacqua

Paper for the POROS Conference of Raipur 12 – 13 October 2006

The Regulation of Genetically Modified Organisms in

International Law: A Bipolar Relationship between

Environment and Trade

Table of Contents

1. Introduction

2. The EC-Biotech case: global harmonized trade versus domestic precaution

3. The role of science and precaution in the Agreement on the application of Sanitary

and Phytosanitary Measures

4. The precautionary approach of the Cartagena Biosafety Protocol

5. GMO: a paradigmatic example of the need for a precautionary approach in multi-

sector and multi-national governance

6. Conclusive observations

1. Introduction.

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The multisectoral and multinational governance of the field of

GMO1 is paradigmatic of the conflicting tension between free trade

and harmonization interests on a side, and the environment and

health protection ones on the other.

By the analysis of a recent WTO dispute (EC-Biotech2) it will be

noted how certain international treaties (in the case at stake the

Agreement on the application of Sanitary and Phityosanytary

measures – SPS) have become effectively binding over internal

domestic regulations and how they have ended up reducing member

states’ discretion over health and environmental matters, so

decreasing also the protection of such rights and goods.

The analysis will focus on the EC-Biotech case (§ 2), stressing on

the role of science (as a tool to harmonize global trade law),

opposed to the discretionary-precautious view (intended as a

reasonable and cautious approach to uncertain fields of

regulation) for which the EU was condemned. The mentioned conflict

will be considered with particular attention to the interpretation

of the SPS Agreement’s provisions (§ 3). Opposed to the rationale

of the latter the Cartagena Biosafety Protocol – CBP will be

examined, as an example of an environmental-oriented approach to

trade (§ 4). The stress will be thus put on the rationale of GMO’s

regulations, as an example of multisectoral and multilayered

governance (§ 5). Finally it will be seen as, in the field of

GMOs, the precautionary principle could be used not to make the

«green» approach to prevail on the trade-oriented one, but rather

1 See G.C. Shaffer – M.A. Pollack, Regulating Between National Fears and Global Disciplines:Agricultural Biotechnology in the EU, NYU School of Law, Jean Monnet Working Paper10/2004, 4 and so forth.2 EC – Measures Affecting the Approval and Marketing of Biotech Products (WT/DS/291, 292, and293), Interim Report of the Panel, Geneva, 7 February 2006 (hereinafter EC-Biotech). Thefinal Repot should be officially published in Autumn 2006.

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to “bridge the gap”3 between the two prevailing narratives of

favour and opposition on biotechnology: “a call to move slowly

with GMOs, but (…) by no means a call to ban them in all cases and

forever”4 (§ 6).

2. The EC-Biotech case: global harmonized trade versus domestic precaution.

In May 2006 the Dispute Settlement Panel of the WTO issued its

final Report on the EC-Biotech case, concerning the European de facto

moratorium against genetically modified organisms5. The

adjudicative body, claiming that the moratorium towards

genetically modified organisms had not yet ceased to exist,

demanded the EU to put its measure into conformity with the

provisions of the SPS Agreement. “The Panel emphasized that its

report did not examine the safety of the biotech products and that

it had not examined the legitimacy of current EC legislation”6.

Nonetheless it considered the EC moratorium as “a de facto

measure, i.e. a measure which was not adopted through a formal EC

rule – or decision-making process, as it is the result of the

application of separate decisions by the group of five (Member

3 J.S. Applegate, The Proemetheus Principle: Unsing the Precautionary Principle to Harmonize theRegulation of Genetically Modified Organism, in Indian Journal of Global Legal Studies, IndianaUniversity School of Law, 2001, 16 and so forth.4 Ibid., 23.5 In the view of the complaining parties (Argentina, Canada and the UnitedStates), in the period from 1998 to 2004, the European Communities did notapprove any import of GM products. According to the complex approval procedure,regulated before by the Directive 90/220/EC and now by the Directive 2001/18/ECof the European Parliament and of the Council of 12 March 2001 (together withRegulations 258/97/EC; 1829/2003; and 1830/2003), no GMO (imported or internallyproduced) has been authorized to be placed in the European market during thattime.6 N. Bernasconi-Osterwalder and M.J. Oliva, Center for InternationalEnvironmental Law (CIEL), EC-Biotech: Overview and Analysis of the Panel’s Interim Report, March2006, 5.

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States) and the Commission”7, which, although not violating any

substantive norm of the SPS Agreement, was still unlawful under

the procedural norm of Art 8 and Annex C(1)(a). The latter

required completing the operational and approval procedures of

GMOs authorization “without unduly delay”. The Panel thus

questioned the inertial behaviour of the European institutions and

of the Member States and it found it to integrate a de facto

protectionist measure, through inaction and omissions.

In addition, the judges of the EC-Biotech found two other contested

measures to be inconsistent with WTO law: 1. a “products specific

moratoria” against 24 GM products, entailed by all the single

applications for the specific products, which, according to the

Panel, have been deliberately failed or unduly delayed (in

violation of Art 8 and Annnex C(1)(a) of the SPS Agreement) in

order to avoid the entrance of those products into the European

market; 2. nine “national import bans” on GM products issued by

six EC members, which, in accordance with article 23 of the EC

Directive 18/2001, have explicitly denied the access to their

market of certain specific GM products, further restricting trade

and violating Art 5.1 of the SPS Agreement.

The decision issued by the Panel presents several meaningful

features, among which one is particularly relevant in the present

analysis: all the three contested measures were found to be

inconsistent with the science-based requirements of the SPS

Agreement and for all of them the Panel excluded the application

of the precautionary principle8 either through the provision of Art

7 EC-Biotech, Interim Report, § 7.1282.8 N. Bernasconi-Osterwalder and M.J. Oliva, EC-Biotech, cit., 37 – 38.

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5.7 of the SPS Agreement, or through the application of the

Cartagena Biosafety Protocol9.

Notwithstanding, the measures enacted by the European Community

and by the member States found their rationale into the scientific

uncertainty over GMOs, for which they required a longer analysis

and more detailed testing before placing the products in the

environment. The Community had opted for a precautionary approach

in order to develop more studies on the field, and following the

rationale of Directive 2001/18/EC which, in accordance with Art

174 of the EC Treaty, foresaw the application of the principle of

precaution. The cornerstone of the decision, as it will be

stressed, was the impossibility to demonstrate either a sufficient

degree of safety or one of harm. The science-oriented burden of

proof of the SPS Agreement which did not admit the use of

uncertainty as a decisional criterion, made thus particularly

hard, for the EC, to demonstrate the reasonability of a more

prudent approach, with a favour to the more trade-oriented policy

of the complaining States.

The strong influence entailed by WTO laws over national or

regional administrations, and the problems of trade issues

prevailing on environmental ones, are strictly connected to the

role of science and to the exclusion of the precautionary

principle. The main drawback of the SPS Agreement has proven to be

its rigid scientific requirements in order to justify health-

9 Both the issue of the “undue-delay”, both that of risk assessment could havebeen justified through the application of the precautionary principle. Howeverthe Panel excluded this possibility as the requirements of Art 5.7 were notsatisfied and The CBP could not be applied to the Complainants, , in accordancewith Art 31 (3)(c) of the Vienna Convention on the Law of the Treaties, as theywere non-ratifying Countries, EC-Biotech, §§ 7.1500 – 7.3405.

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related trade barriers10. The latter can be accepted only if they

rely on an international standard, or, when a standard does not

exist or the national State wants to issue a stricter regulation,

on a scientific justification. In such a case the DSB does not

consider the reasonability and the internal legitimacy of a

Country’s decision, but only the scientific reports it provides.

So far science has seemed to be the most effective instrument to

ensure an objective control by global regulators’ and to justify

national regulations. However, science has also the effect to

decrease national authorities’ discretion and people’s

sovereignty. In addition, in many fields it has often demonstrated

to be unable to assure an objective and univocal response to

legitimize a common uniform policy, to solve the doubt between

safety and harm.

As it stems by the mentioned decision and as it will be seen in

the following paragraphs, the science-related view entailed by the

SPS Agreement and confirmed by the DSB interpretation, has so far

constantly overcome the environmental and health regulations of

the member States. This approach has fostered global trade and

harmonization but it has reduced national effective sovereignty

over such fundamental rights as health or the environment, often

10 “The (…) SPS Agreement, (…), requires that countries either adopt harmonizedinternational standards or, if they choose to maintain stricter regulations,base these on risk assessment, scientific principles, and scientific evidence.The SPS Agreement also requires that the regulations adopted be the least trade-restrictive available to achieve the desired level of protection. The aboveprovisions apply even to nondiscriminatory regulations that would not run afoulof the Most Favored Nation and National Treatment provisions of the GATT itself.The SPS Agreement also prohibits ‘arbitrary’ and ‘unjustified’ distinctions inlevels of protection in situations that are comparable, where these distinctionslead to ‘discrimination’ or ‘disguised restriction on trade’. Such stricturesappear to provide fuel for criticism that globalization suffers a ‘democraticdeficit.’”, R. Howse, Democracy, Science, and Free Trade: Risk Regulation on Trial at the WorldTrade Organization, in Michigan Law review, June 2000, 2329.

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(in cases of uncertainty) without being able to provide a balanced

or neutral decision between the conflicting interests.

3. The role of science and precaution in the Agreement on the application of Sanitary

and Phytosanitary Measures.

In the Biotech case the Panel found GMO’s regulation (namely the

EC one) to fell under the scope of the SPS Agreement11. According

to the latter, the restriction of the market of GM products for

health concern’s reasons can be admitted either relying on

international standards or through scientific evidence,

demonstrating the likelihood (and not the mere possibility) of risk

(Art 2.2, 3, 5.1, SPS Agreement)12. The only exception to this

model is disciplined at Art 5.7. Its content has been defined by

the Panel as an autonomous right of the member states, to adopt

the measure they consider more appropriate, to protect their

citizens from health-related risks13. However, the adjudicative

body of the WTO also added that Art 5.7 is a qualified right, as,

for a national SPS measure to be consistent with, it needs to

11 EC-Biotech, §§ 7.147 – 7.429.12 “The risk evaluated in a risk assessment must be an ascertainable risk;theoretical uncertainty is not the kind of risk which, under Article 5.1, is tobe assessed”, Australia – Measures Affecting Importation of Salmon, Report of the AppellateBody, WTO Doc. WT/DS18/AB/R (Oct. 20, 1998), available at www.wto.org.13 “We find the general test provided by the Appellate Body in EC – Tariff Preferencesto be applicable, and application of that test leads us to the conclusion thatArticle 5.7 should be characterized as a right and not an exception from ageneral obligation under Article 2.2. In other words, we consider that in thesame way that ‘Article 3.1 of the SPS Agreement [...] excludes from its scope ofapplication the kinds of situations covered by Article 3.3 of that Agreement’,Article 2.2 excludes from its scope of application the kinds of situationscovered by Article 5.7. As we will explain further below, characterizing Article5.7 as a right rather than as an exception has implications for the allocationof the burden of proof”, EC-Biotech, § 7.2960 (footnotes omitted).

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satisfy all the four cumulative requirements of the provision14.

Among those the cornerstone is certainly the first one, regarding

scientific sufficiency to produce a risk assessment.

In EC-Biotech the Panel established an interlink between the

provisions of Art 5.7 and 5.1, asserting that “scientific evidence

is ‘insufficient’ within the meaning of the first sentence of Art

5.7 only if it does not allow the performance of an assessment of

risk as defined in Annex A”15. The latter defines the procedure of

risk assessment as “the evaluation of the likelihood of entry,

establishment or spread of a pest or disease within the territory

of a Member State”, to be adopted for the application of Art 5.1.

This interpretation, however, exclusively relies on the

impossibility (“does not allow”) of a risk assessment, and so it

excludes, from the scope of Art 5.7, all those assessments which,

despite being able to perform the evaluation of Annex A, are still

unable (for divergent opinions, uncertainties, necessity of long-

period evaluations) to assure or exclude the occurrence or the

development of a risk16. Moreover the only threshold for scientific

certainty required by the SPS is the threshold of not being

14 “(1) The measure is imposed in respect of a situation where “relevantscientific information is insufficient”; and (2) adopted “on the basis ofavailable pertinent information”; however, such a provisional measure may not bemaintained unless the member which adopted the measure (3) “seek[s] to obtainthe additional information necessary for a more objective assessment of risk”;and (4) “review[s] the … measure accordingly within a reasonable period oftime”, Appellate Body Report, Japan – Measures affecting the Importation of Apples,WT/DS45/AB/R, 10 December 2003 (hereinafter Japan - Apples), § 89. See also EC-Biotech, at § 7.2989.15 Ibid., § 7.2986.16 “A risk assessment is conclusive proof that the risk will be x, and only x,when the study is designed in a specific manner, but it is not irrefutable proofthat other scientific theories leading to different assumptions about risk arewrong”, A. Herwig, The Precautionary Principle in Support of Practical Reason. An Argument AgainstFormalistic Interpretations of the Precautionary Principle, in C. Joerges & E.-U. Petersmann(eds.), Constitutionalism, Multilevel Trade Governance And Social Regulation, forthcoming withHart Publishing, Oxford, 2006, 318.

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maintained without “sufficient scientific evidence” contained in

SPS Art 2.2. Therefore national regulators should be able to act

to adopt a cautious approach towards serious harm even where a

risk assessment is uncertain so long as the uncertainty was based

on sufficient scientific evidence and further examination was

unwarranted.

In addition the Panel stated that “even if a Member follows a

precautionary approach, its SPS measures need to be ‘based on’

(i.e., ‘sufficiently warranted’ or ‘reasonably supported’ by) a risk

assessment. Or, to put it another way, such an approach needs to

be applied in a manner consistent with the requirements of Article

5.1”17. Therefore, following the rationale of an objective and

impartial science, precaution is admitted only after and upon the

risk assessment phase. However, as demonstrated in the previous

legal doctrine, the AB has repeatedly and strongly affirmed the

insufficiency of a precautious risk management act to justify a

SPS measure18 as it cannot be considered sufficiently objective to

exclude disguised protectionism. Combining the two

interpretations, the DSB has then excluded precaution both from

the phase of risk assessment (which must be exclusively based on

science), both from that of risk management (which cannot be used

17 EC-Biotech, § 7.3056.18 In Appellate Body Report, EC – Measures Concerning Meat and Meat Products (1998),WTOAppellate Body 1998, WT/DS 48/AB/R (hereinafter EC-Hormones), the AB required arational relation demonstrated in the risk assessment, then it demanded arational relationship with risk management, denying discretion to the managersand unifying the two phases (when it stated that “it is not only riskascertainable in a science laboratory operating under strictly controlledconditions, but also risk in human societies as they actually exist, in otherwords, the actual potential for adverse effects on human health in the realworld where people live and work and die”, § 187), so that in front of the Courtthe discretional phase of management could not be used, being absorbed by thescientific evaluation of risk. On these issues see R. Howse, Democracy, cit.,2337.

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as a justification without an appropriate risk assessment), so

considerably reducing the application of the qualified right

embodied in Art 5.719, also when risk assessment’s results are so

ambiguous to suggest a discretional decision among more options in

the management phase.

The Panel finally observed that “the adequate risk assessment”20

cannot be left to the prudent evaluation of the national

governors, but it must be determined in an objective way. To do so

it again recalled the definition of Annex A of the SPS Agreement:

“a risk assessment would be ‘adequate’ if it meets the standard

and definition provided in Annex A”21. This interpretation, which

is in a progressive continuum with the previous legal doctrine on

the subject22, absorbs the domestic authorities’ discretion of the

phase of risk management, into the narrow scientific requirements

of the one of risk assessment. So that only when the Member States

can establish that the available science does not allow a risk

assessment at all, Art 5.7 can apply, while if an assessment is

possible but its results are considered inadequate by national

19 The DSB has always given a narrow interpretation of this provision, reducingit to a scientific demonstration, and denying the application of theprecautionary approach. The interpretation and the scope of the precautionaryprinciple have been crucial in three cases under the SPS Agreement: EC- Hormones;Appellate Body Report, Japan – Measures Affecting Agricultural Products I and II, WT/DS76/AB/R,Feb. 22, 1999 (hereinafter Japan – Agricultural Products); Japan - Apples, and in all ofthem the AB excluded its application.20 Japan - Apples, cit., § 182.21 EC-Biotech, cit., § 7.3226.22 For what concerns “relevant scientific evidence” the AB has been clear: thescientific data “will be ‘insufficient’ within the meaning of Article 5.7 if thebody of scientific evidence does not allow, in quantitative or qualitativeterms, the performance of an adequate assessment of risks as required underArticle 5.1”. Further the AB supported its argument by stating that: “theapplication of Article 5.7 is triggered not by the existence of scientificuncertainty, but rather by the insufficiency of scientific evidence. The text ofArticle 5.7 is clear: it refers to ‘cases where relevant scientific evidence isinsufficient’, not to ‘scientific uncertainty’. The two concepts are notinterchangeable”, Japan – Apples, §§ 179 and 184.

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States, these are not free to determine their appropriate levels

of protection, as foreseen by the Preamble and by Art 423 of the

SPS Agreement. The latter provisions, read in conjunction both

with Art. 5.4, which requires States to “take into account the

objective of minimizing negative trade effects” recalling the

proportionality principle24, both with Art 5.7 which allows them to

have a precautionary approach in case of insufficient evidence on

the risk, should entail a certain degree of reasonable discretion

for the competent domestic authorities in regard to issues covered

by scientific uncertainty25.

According to the prevailing interpretation of the SPS Agreement,

the latter does not allow much discretion to the national

authorities in determining certain trade-related health measures.

Thus it excludes the possibility to adopt a precautious approach

in the risk management phase and allows them to avoid risk

assessment only through an objective demonstration that, due to

the insufficiency of scientific evidence, such procedure is

23 “Further the use of harmonized sanitary and phytosanitary measures betweenMembers, (…), without requiring Members to change their appropriate level ofprotection of human, animal or plant life or health” (Preamble); “Members shallaccept the sanitary or phytosanitary measures of other Members as equivalent,even if these measures differ from their own or from those used by other Memberstrading in the same product, if the exporting Member objectively demonstrates tothe importing Member that its measures achieve the importing Member's appropriate level ofsanitary or phytosanitary protection” (emphasis added) (Art 4, Equivalence).24 This provision has been defined as the “proportionality test”, which aims atverify “whether the governmental measure under review has an excessive ordisproportionate impact on the applicant’s interests”, F. Ortino, From “‘non-discrimination” to “reasonableness”: a paradigm shift in international economic law?, Jean MonnetWorking Papers, n. 1/2005, available at http://www.jeanmonnetprogram.org/papers,35.25 “As language such as ‘based on’ and ‘take into account’ suggests, the SPSAgreement brings science in as one necessary component of the regulatoryprocess, without making it decisive. Thus ‘sufficient scientific evidence’arguably refers to the evidence that is needed if science is to play thisdemocratic role in risk regulation, not to some threshold of scientific proof orcertainty below which democratic judgements about risk are illegitimate”, R.Howse, Democracy, cit., 2336.

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impossible, in accordance to the definition of Annex A, of the

same agreement. The SPS Agreement, in the dispute settlement

bodies’ view, reduces local jurisdiction, limiting the decision-

making phase to the assessment of risk, even in case of scientific

uncertainty. The precautionary principle is therefore excluded by

the treaty as a discretional evaluation, and management of risk is

also neglected in favour of science-based harmonization.

The described science-oriented procedure has, among the others,

one relevant substantial consequence: burdening on the importing

countries, which issued a measure to protect health or the

environment, that have to be objectively justified, it produces a

prevalence of trade interests over environmental and health-

protection ones, in all those cases of scientific uncertainties

when a risk is considered possible but cannot be proven likeable.

4. The precautionary approach of the Cartagena Biosafety Protocol.

The Cartagena Biosafety Protocol (CBP) entered into force on the

11th of September 2003. It counts 111 member states and is the most

recent and specific international agreement, concerning

genetically modified organisms. Its scope is limited to “living

modified organisms – LMOs” (so only seeds or active substances

fall under its provisions, not finished products), while its main

aim is “to contribute to ensuring an adequate level of protection

in the field of safe transfer, handling and use of LMOs” (Art 1).

Therefore it involves trade, but only indirectly, as the main

purpose is to guarantee safety (health and environmental

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protection from eventual harmful effects derived from LMOs), even

through the restriction of trade26.

To reach its objectives the CBP foresees the use of the

precautionary principle (Art 1) and of the “Advanced informed

agreement – AIA” procedure27. The AIA procedure could consist of a

trade restrictive tool in the hands of national member countries28,

as the importing State are allowed to require a risk assessment

from the exporter and if the latter does not have evidence enough

to prove the safety of his products, the former can refuse them.

If compared with the burden of proof requested to the importer by

the Appellate Body of the WTO29, the AIA procedure results to

entail the opposite view, as it switches the burden of proof on

behalf of the exporter. Moreover, the CBP allows Parties to use

the precautionary principle, in the evaluation of risk assessment

presented by the importer, while the SPS Agreement excludes its

26 L. Boisson de Chazournes and M. M. Mbengue, GMOs and Trade: Issues at Stake in the ECBiotech Dispute, in RECIEL 13(3), 2004, 290 and so forth.27 The latter is the core of the treaty and it consists of an authorizationprocedure related to trade of LMOs (“intentional trans-boundary movement”, Art7). It is set out in Arts 7-10 and 12 of the CBP. Art 8, together with Annex I,provides a duty for the exporter to send a written notification to the countryof import. This document must contain all the information about the product,including a risk assessment. Then, the Party of import has to take a decision(Arts 9-10), for which it has four options: 1) approving the import, with orwithout conditions, including how the decision will apply to subsequent importsof the same LMOs, 2) prohibiting the import, 3) requesting additional relevantinformation in accordance with its domestic regulatory framework or Annex I, or4) extending the period for decision-making (Art 10(3) (a-d)). This decision canbe taken in accordance with the precautionary principle (Arts 10(6) and 11(8)).On the issue see L. Boisson de Chazournes and M. M. Mbengue, GMOs and Trade, cit.,292. 28 “While the CPB is an international environmental agreement, it addresses theinternational movement of ‘living modified organisms’ (‘LMOs’) and thereforeimpacts trade”, J.M. Migai Akech, Developing Countries at Crossroads: Aid, Public Participation,and the Regulation of Trade in Genetically Modified Foods, in Fordham International Law Journal,January 2006, 272.29 The exporter has only a prima facie burden of proof as a complaining party, butit is the State which issued the SPS measure that has to justify it, relying onan international standard or proving the likelihood of an ascertainable risk.

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application to these phase, leaving a limited possibility only if

the risk assessment is impossible, as required by Art 5.730.

Paragraph 9 of the Convention31 on Biological Diversity’s

Preamble states: “Noting also that where there is a threat of

significant reduction or loss of biological diversity, lack of full scientific

certainty should not be used as a reason for postponing measures to

avoid or minimize such a threat” (emphasis added). The word

“threat” and the phrases “significant reduction” and “lack of…

certainty” prove the application of a broad interpretation of the

precautionary principle. Without demanding the likelihood of risk,

a simple threat of significant (but not irreversible or grave)

reduction of biodiversity is considered sufficient to satisfy the

«risk requirement». Moreover, for what regards the scientific

inadequacies, the word “uncertainty” clearly distinguishes from

the more demanding “insufficiency” of the SPS Agreement. Following30 However if Art 5.7 is interpreted in combination with Art 4.1 of the sameagreement, which foresees the duty for the “exporting Member to objectivelydemonstrates that its measures achieve the importing Member's appropriate levelof sanitary or phytosanitary protection”, an analogous precautious anddiscretional approach should be implied from the reading of the SPS Agreement,as far as the importing Member can prove that insufficient science is unable toproduce an adequate risk assessment. While the two risk assessment proceduresare different (the CBP implies a precautionary approach in it and includes riskmanagement as justification for trade restriction), the precautionary approachof article 10.6 CBP (“Lack of scientific certainty due to insufficient relevantscientific information and knowledge”) is written in a very similar way to theprovision held in article 5.7 SPS Agreement (“relevant scientific evidence isinsufficient… on the basis of available pertinent information”). The maindifference is that the former foresees insufficiency as a cause of uncertainty,which, together with a potential threat, is reputed enough to restrict trade. Onthe contrary the SPS provision, by excluding uncertainty, requires only absoluteinsufficiency of science to allow a risk assessment for restricting trade. Onthe relationship between the two agreements see B Eggers and R. Mackenzie, TheCartagena Protocol on Biosafety, in Journal of International Economic Law, 2000, 542; check alsoN. Bernasconi-Osterwalder, The Cartagena Protocol on Biosafety: a multilateral approach toregulate GMOs, in E. Brown Weiss and J. H. Jackson (eds.), Reconciling environment andtrade, Ardsley, N.Y., Transnational Publishers, 2001, 716 – 719.31 The Convention is an international Agreement, which was signed in June 1992,and entered into force in December 1993. It counts 188 members, and establishedand prepared the preparation and ratification of the CBP.

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this approach, also the Biosafety Protocol, as implementation of

the Convention, has included a broad view of the precautionary

principle, which allows member states to restrict their markets on

the basis of potential adverse effects and scientific

uncertainty32.

Although the approach under the Cartagena Biosafety Protocol

risks being too paternalistic, in giving national administration

too wide discretional powers, limiting citizens’ choices and

rights to participate33, it is still coherent with the

32 Article 1 of the Biosafety Protocol, states: “In accordance with theprecautionary approach contained in Principle 15 of the Rio Declaration onEnvironment and Development, the objective of this Protocol is to contribute toensuring an adequate level of protection in the field of the safe transfer,handling and use of living modified organisms resulting from modernbiotechnology that may have adverse effects on the conservation and sustainableuse of biological diversity, taking also into account risks to human health, andspecifically focusing on transboundary movements”. Furthermore, Article 10(6) ofthe Protocol states: “Lack of scientific certainty due to insufficient relevantscientific information and knowledge regarding the extent of the potentialadverse effects of a living modified organism on the conservation andsustainable use of biological diversity in the Party of import, taking also intoaccount risks to human health, shall not prevent that Party from taking adecision, as appropriate, with regard to the import of the living modifiedorganism in question as referred to in paragraph 3 above, in order to avoid orminimize such potential adverse effects”.33 “The CPB conceptualizes public participation largely in terms of providinginformation to the public rather than as a ‘strategic opportunity to makeinformed, legitimate and effective policies’, (D. Glover, Public Participation inNational Biotechnology Policy and Biosafety Regulation, in Univ. of Sussex Inst. of Dev. Studies,Working Paper No. 198, 2003, 2 – 3). Thus, the role of the public is to be apassive recipient of information about biotechnology, and their ignorance is tobe cured through education and awareness-raising activities. Because the publicis invited to ‘participate’ only after science has made the value judgments, thespace for public participation is circumscribed. The public does not thereforeget an opportunity to help frame the scope of regulation”, J.M. Migai Akech,Developing Countries, cit., 277. It is to note that Art 23 contains explicitprovisions on access to information, requiring contracting parties to promoteand facilitate: public awareness, education and participation concerning safetransfer, handling and use of LMOs in relation to biodiversity conservation.However these requirements, contrary to the WTO model, are left to theCountries’ discretional jurisdiction: “in accordance with their (of the States)respective laws and regulation”. This approach leaves a considerable amount ofdiscretion for governments and does not require changes to a status quo thatmight be inadequate at present.

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environmental orientation of the agreement. The main criticism

over this treaty concerns the lack of counterbalances to avoid the

use of paralyzing or arbitrary precaution which, as the Biotech case

has demonstrated34, contrast with the provisions of the SPS

Agreement and might be used as disguised restriction of trade35.

And this is the reason why the main producing Countries of

genetically modified organisms (Argentina, Canada and USA) did not

ratify the Protocol, so that then the Panel could not consider it

in the Biotech case.

The rationale of the CBP, however, seems to be of a political

nature, as a reply to the too stringent WTO regime, through the

creation of a strong (the Protocol has a binding force over

ratifying Countries) legal instrument in the hands of States

willing to maintain sovereignty over areas of uncertain risk

regulation. This provides a typical example of the sectoral

fragmentation of the global governance, where the policy-makers of

the different sectors have a narrow vision of the problems,

usually restricted to one or two fields of regulation36. And it

shows how, in the global arena, two analogous legal instruments

34 EC-Biotech, §§ 7.49 and so forth.35 The CBP “is, fundamentally, a trade agreement pertaining to agriculturalcommodities produced using modern biotechnology that is solely concerned withestablishing the rules under which countries can limit imports. (…). This leavesthe regulation of imports of these products open to influence by a broad rangeof protectionist interests that have nothing to do with protection of theenvironment”, in A. L. Hobbs, J. E. Hobbs, and W. A. Kerr, The Biosafety Protocol:Multilateral Agreement on Protecting the Environment or Protectionist Club?, in Journal of World Trade,39 (2), 2005, 281.36 “Il diritto globale è composto di tanti sistemi diversi, che producono una patologica relatività normativa.I diversi regimi regolatori rispondono ciascuno a precise esigenze settoriali, ciascuno con la sua razionalità.(…). Tanti sistemi settoriali, anche molto complessi, non fanno, però, un governo globale”. S. Cassese,Come nasce un ordine giuridico globale, unpublished draft, 6; on a similar viewconcerning sectoriality, from another discipline’s perspective, see also J.Stiglitz, Globalization and Its Discontents, New York – London, Norton, 221 and soforth.

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(multilateral treaties) present two opposite faces (environment

and trade) of the same drawback: i.e. sectoriality.

5. GMO: a paradigmatic example of the need for a precautionary approach in multi-

sector and multi-national governance.

The debate over genetically modified organisms is, as noted,

characterized by a high degree of uncertainty, not only about the

harm they could cause, but also concerning the benefits and/or the

damages that their diffusion might produce.

Benefits37. The possible advantages brought by biotechnology

concern: an increased agricultural output38; a more nutritious

food39; environmental benefits40 (“biotech products that are

resistant to insect pests require less insecticide”)41; health

benefits (transplant surgery and creation of low cost medicines).

Damages42. The use of GMOs could bring some ascertained damages

as well as some possible ones, mainly concerning health and the

37 The scientific references hereinafter reported are cited in EC – Biotech, FirstSubmission of the US, April 21, 2004, 4 – 9.38 “Modern biotechnology can significantly increase agricultural output byprotecting plants from factors that reduce yields, such pests, diseases”, Reportof the National Academy of Medicine and National Academy of Pharmacology, Howcan genetic engineering contribute to the improvement of human health and food, and what are theobstacles to its application in this area?, November 26, 2002, 1.39 “The power of genetic engineering to improve the nutritional quality of ourfood crop species is (…) immense”, N.E. Bourlang, Ending World Hunger. The Promise ofBiotechnology and the Threat of Antiscience, Zealotry, Plant Physiology, 2000, 487; Checkalso the “Golden Rice” case at M. McGloughlin, Why Safe and Effective Food Biotechnology isin the Public Interest, The Washington Legal Foundation Critical Legal Issues, WorkingPaper Series No. 99. Washington, D.C., USA: The Washington Legal Foundation,2000; for an opposite argument on the samae issue check V. Shiva, Stolen Harvest: theHijacking of the Global Food Supply, Research Foundation for Science, Technology andEcology, 2000.40 A “cleaner agriculture”, Will clean agriculture be transgenic?, October 2, 2001, availableat http://europa.eu.int/comm/research/news-centre/enagr/01-09-agr03d.html.41 National Academy of Sciences, Transgenic Plants and World Agriculture, July 2000, 487.42 The scientific references hereinafter reported are cited in EC – Biotech, FirstSubmission of the European Communities, Geneva, 17 May 2004, 14 – 24.

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environment: toxicity43; allergenicity (known consequence for some

160 different substances44); horizontal gene transfer and,

consequently, antibiotic resistance45; non-target effects46;

invasiveness and development of resistance47; unintended effects

arising through GMO related management practices48; biodiversity-

preservation of the centre of origin49.

GMO regulations generally concern several areas of society:

health, agriculture, environment, food safety, consumer

protection, and trade. These sectors, however, present a factual

transboundary feature, for which they can no longer be regulated

exclusively upon internal legislation. In addition, when

regulations are related to trade (GMOs are tradable goods)

harmonization is required, for the developing interdependencies of

the economies and in accordance with the commitments of the

agreements establishing the WTO, which aim to avoid any form of43 “Through genetic manipulation, plants which do not naturally contain toxinsmay become toxic or capable of inherent toxin production”, R. M. Russel, Thevitamine A spectrum: from deficiency to toxicity, 71 American Journal of Clinical Nutrition,2000, 878.44 S. L. Hefle, J. A. Nordlee and S. L. Taylor, Allergenic Foods, 36 Crit. Rev. FoodSci. Nutr. S69, 1996.45 “Foreign and transgenic DNA has been shown to persist in the stomach andintestine of animals after ingestion of GM products and can be taken up into thecells and nuclei of the receiving organism”, R. Schubbert, U. Hohlweb, D. Renz,and W. Doerfler, On the fate of food ingested foreign DNA in mice: chromosomical associations andplacental transmission to the fetus, 259 Molecular and General Genetics, 1998.46 The inserted toxins could harm and kill insects which are not pests, damagingbiodiversity. Check A. Hillbeck et al., Toxicity of Bacillus thuringiensis Cry 1 Ab Toxin to thePredator Chrysoperla carnea, 27 Environ. Entomol. 1255, 1998.47 “The resistance-gene may outcross into other plants”, FDA Talk Paper, FDA Actionon Corn Bioengineered to Produce Pharmaceutical Material, U.S. Food and Drug Administration,T02-46, 19 Nov. 2002. 48 “The use of GM crops as opposed to conventional crops may lead to a change inagricultural and management practices. Such changes, based on the specific GMcrop in question, may have adverse effects on the agro-ecological environmentand biodiversity” EC – Biotech, First Submission of the European Communities,Geneva, 2004, 21.49 The centre of origin of a species is an invaluable and irreplaceable source ofgenetic material for plant breeding and the genetic modification could harm it,Ibid., 23 – 24.

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disguised protectionism, restricting global commercial

transactions.

Genetically modified organisms are new products still covered by

a high degree of scientific uncertainty50; they are not yet

produced and widely traded in Europe (as in many other

Countries51); they have a strong multidimensional impact, which

would orient the development and the regulations of several

sectors of the society52, such as traditional or organic

agricultural productive methods53. Several national States and the50 GMO is “an organism, with exception of human beings, in which the geneticmaterial (DNA) has been altered in a way that does not occur naturally by matingand/or natural recombination”, Directive n. 18/2001. Genetic modificationconsists of the use of modern techniques of genetic enhancement, which allow theimprovement of biological organisms beyond that which is attainable usingnatural selection and controlled breeding. What has arisen most debate is theso-called trans-species genetic modification: this allows gene transfers thatwould be impossible with traditional breeding. In particular, transgenicmodifications involve modifying cell information by artificially transferringthe genes from one species into another. Most of the concerns and of thescientific disputes relate to this last technique. “Technologically baseduncertainty stems from factors that include the inherent imprecision ofcurrently employed rDNA techniques, the use of powerful, often viral, promotersequences in genetic constructs, and the generation in GMOs of novel proteins towhich humans and animals have never been exposed; scientific uncertainty alsoresults from the still-considerable ignorance of the composition, and seriousinadequacies in studies conducted to assess the potential health andenvironmental impacts of GMOs”, EC – Biotech, Amicus Curiae Brief, Geneva, June 1st,2004, 4 – 5.51 “While the estimated global area of transgenic or genetically modified (GM)crops continues to increase the vast majority of acreage (99 per cent) remainsconfined to just four countries, namely the US, Argentina, Canada and China”, H.Baumüller, Domestic Import Regulations for Genetically Modified Organisms and Their Compatibilitywith WTO Rules, TKN paper available athttp://www.tradeknowledgenetwork.net/publication.aspx?id=587, 33.52 “The principal contemporary concerns (regarding GMOs) may be placed in sixgeneral categories: (…) A) equitable concerns regarding the patenting of GMproducts (…); B) the level of transparency for exports of GM products (…); C)import bans on GM products (…); D) liability for damage by GM products (…); E)liability for damage for extraterritorial damage by GM products (…); F) long-term decline in global biological diversity”, S.D. Murphy, Biotechnology, cit., 6– 17.53 According to some, the market restriction to GM products, while being a tradebarrier potentially decreasing consumers’ choices, might, on the contrary,increase their protection from the risk of a biotechnological monopoly, whichwould as well affect their freedom of choice. “Critics argue that a widespread

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EU adopted a precautionary, discretional and accountable approach

to GM regulation. Others (among which the three complaining

parties of the Biotech case: Argentina, Canada and USA), however,

oriented towards a more permissive model, stressing more on the

advantages of bio-technology, than on its risks. As GM products

are also tradable goods it has been rather difficult to agree a

common and harmonized framework of laws concerning their commerce.

And this fragmentation finally led to the aforementioned problems

of sectoriality, imbalanced interests’ representation and

fragmented legislation.

A relevant example of the conflicting implications of the global

biotechnology regulation can be found in the Indian legal system.

Although the latter provides risk assessment criteria which are

not distinct from their western counterparts, for what concerns

GMO they do diverge from such models in one significant way: a

further requirement has been added, including an agronomic

evaluation of the transgenic crop to determine economic advantage

to farmers: the demonstration that a transgenic crop is both

“environmentally safe and economically viable” (Department of

Biotechnology, Revised Guidelines for Research in Transgenic Plants, 1998, Sec.

6). This addition constitutes an integral component of the

technical risk assessment, along with the ecological and human

health safety evaluation: it is required before a “biosafety

clearance” 54 can be issued to a transgenic crop, and it implies a

LMO technology in agriculture will benefit a few large multinational companiesand allow them to establish a global cartel to the detriment of the world’sconsumers and farmers. An antitrust suit has already been filed on this groundin the US (B. Picket, et al. v. Monsanto Co., Case No 1:99)”, T.J. Schoenbaum,International Trade in LMOs: The New Regimes, in International and comparative law quarterly, 2000,857.54 A. Gupta, Governing Biosafety in India: The Relevance of the Cartagena Protocol, Belfer Centerfor Science and International Affairs (BCSIA), Discussion Paper 2000-24,Environment and Natural Resources Program, Kennedy School of Government, Harvard

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costs/benefits analysis already in the scientific assessment of

the risk. This is a controversial aspect of the precautionary

principle: on one side a precautious risk assessment might entail

unaccountable scientists of a too wide discretional power, on the

other it might be useful to orient science when already the

scientific evaluations present the necessity of a choice

(scientific policy).

Another respect is to be mentioned: “in developing countries,

including India, biotechnology products are also seen as

instruments for achieving food security and addressing the

prevalent productivity stagnation in the green revolution

varieties”55. However, it has been noted that GM crops can also

have the opposite effect. They are likely to be more expensive to

purchase and maintain, and are thus unlikely to solve the problem

of food security since “poverty, rather than inadequate

agriculture (…) remains the basis for hunger among the people of

developing countries”56. In addition, the multinational

corporations might establish a monopolistic control of developing

countries’ food and seeds market. As “agricultural products

constitute developing countries’ principal exports to Europe and

the United States”57, the way they regulate GM production contains,

in addition to environmental issues, also several decisive

socioeconomic implications. “The requirement to demonstrate that a

transgenic crop is both ‘environmentally safe and economically

University, 2000, 15, available at http://environment.harvard.edu/gea.55 S. Chaturvedi – L. Chawii, Biosafety, cit., 18.56 Michelle K. McDonald, International Trade Law and the U.S.-EU GMO Debate: Can Africa WeatherThis Storm?, 32, in Ga. J. Int'l & Comp. L. , 501, 504 (2004) , 522.57 J.M. Migai Akech, Developing Countries, cit., 270. On the relationship betweenagricultural economy and environmental degradation in India see R.N.Chakraborty, Linkages between Income Distribution and Environmental Degradation in Rural India, inS.T. Madsen (ed.), State, Society and the Environment in South Asia, 165 and so forth.

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viable’ is the clearest evidence of these interlinkages. This

requirement can be seen as both ‘scientifically sound’ (if

scientific assessments include a broader conception of assessable

impacts to include the socioeconomic) as well as ‘socially

precautionary’ thus effectively merging all three decision-criteria

for consent”58. As the issue of the environment, as well as the one

of social protection, is considered rather relevant in Indian

legal system, the administrative regulation of GMOs has provided a

strong application of the precautionary principle in order to

enact a slow and prudent approach to such a delicate issue.

6. Conclusive observations.

Whereas domestic public regulators deal with trade-related

health or environmental issues, they have to act in conformity

with global trade law. The multilateral system created with the

Marrakech Agreements has become currently and progressively more

and more intrusive towards domestic policies. The centrality of

trade and the openness of the markets have had the effect to

establish strong linkages between several sectors of society and

trade, so that the former are usually influenced by the latter,

unless the market is to be restricted on the ground of a sound and

objective scientific report59.58 A. Gupta, Governing Biosafety, cit., 27.59 One example of the described trend is the global common regulation of foodsafety measures, which are notably intertwined with global trade. On this seeD.W. Leebron, Linkages, “The Boundaries of the WTO”, in American Journal of International Law,n. 96, 2002, 14, S. Battini, Il sistema istituzionale internazionale dalla frammentazione allaconnessione, in Riv. Ital. Dir. Pubbl. Comunitario, 2002, 985 – 986. On the issue check alsoS. Poli, The EC and the Adoption of International Food Standards within the Codex AlimentariusCommission, in European Law Journal, 2004, 616; A. Herwig, Transnational GovernanceRegimes for Food derived from Bio-Technology and their Legitimacy, in C. Joerges, I. J. Sandand G. Teubner (ed.), Transnational Governance and Constitutionalism, Oxford and PortlandOregon, Hart, 2004, 210 ss.; D. Bevilacqua, The Codex Alimentarius Commission and its

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The field of genetically modified organisms’ regulation is a

significant example of such an interests-conflicting area. The

regulation of biotechnology is still governed by scientific

uncertainty and reveals several different approaches, either in

national regulations, or in international ones: “a trans-national

biotechnology regime is emerging based on the self-interest of

States and non-States actors, on the social interaction among

those actors through institutions and non-governmental

organizations and on the national law, regulations and policies

that clarify, interpret and implement international law”60. In such

a multi-dimensional area, ruled by indeterminacy and affecting

several conflicting interests, trade is so far prevailing on other

constitutional-valued issues, such as protection of health. And

that is why a shared use of precaution has often been invoked.

Nonetheless, the principle at stake revealed to have still

different interpretations, definitions and scope either in

domestic or in international institutions, without being able to

reach the status of a binding principle of international law61.

On behalf of the precautionary principle, it is to be said that

its developing nature of procedural and teleological principle

might have the effect of balancing multisectorial regulation,

Influence on European and National Food Policy, in.European Food and Feed Law Review, n. 1/2006,3 and so forth.60 S.D. Murphy, Biotechnology and International Law, in Harward International Law Journal,2001, 47.61 This is one of the argument against the precautionary principle. For instancesome authors have argued that the principle has “an elusive concept” andtherefore has a questionable status in international law; others stated that “atpresent… (it) is not a term of art”, respectively L. Gundling, The Status inInternational Law of the Precautionary Principle, in International Journal of Estuarine and Coastal Law,V, 3, 1990, 25 and G. Handl, Environmental Security and Global Change: the Challenge ofInternational Law, in Handl (ed.), 1 Yb. Int’l Env.L., 1990, 23. Both quoted by T. T.O’Riordan, J. Cameron, A. Jordan, Reinterpreting the precautionary Principle, London,Cameron May, 2001, 116.

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fostering a pluralistic approach. Combining the principles of

impartiality, proportionality and reasonability, the precautionary

principle indicates, through the twofold requirement of scientific

uncertainty over risk-possibility, when public authorities must

have the discretion to adopt a prudent policy62. In the global

governance, this principle should be used to balance multiple

interests in conflict, as it happens in the European legal system,

and not widened so much to favour arbitrariness, nor reduced and

frustrated under scientific justifications, which turn to be

inadequate policy tools in a situation of scientific uncertainty63.

“Rather than asking what level of contamination is safe or

economically optimal, the precautionary approach asks how to

reduce or eliminate the hazard and considers all possible means of

achieving that goal, including forgoing the proposed activity.

Needless to say, alternatives proposed to a potentially hazardous

activity must be scrutinized as stringently as the activity

itself”64.

Finally the precautionary principle implies a costs/benefits

analysis and it is “capable of fostering accountability vertically

between levels of governance and, paradigmatically, between the

62 What is written in Rio Declaration or CBP implies a compulsory rationale(“should be avoided”), while the precautionary approach of the SPS is notcompulsory, but it must be seen as a procedural and qualified (it must respectthe four requirements of art. 5.7) right left to the discretion of domesticdecision-makers, in accordance with the principle of good administration (goodgovernance). The mere perception of risk is not enough if there is enoughscience information to control it, but the combination of “mere possibility” andscientific uncertainty (also about its developing or effects) makes theprecautionary principle apply.63 “When ignorance and incommensurability are acknowledged to be firmly groundedin the science of risk assessment, then it follows that a more broadly-based,pluralistic and epistemologically humble precautious approach is more scientificthan traditional narrow risk assessment”, T. O’Riordan, J. Cameron & A. Jordan,Reinterpreting, cit., 82.64 J.M. Migai Akech, Developing Countries, cit., 269.

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politics of anxiety and the politics of risk”65. The procedural

interpretation of the precautionary principle puts it in the

middle between a fear-oriented approach, which would have

paralyzing or protectionist effects and a technocratic one, which

might accept unreliable scientific justifications without

considering social and long-period drawbacks66.

In this way it would not be an obstacle trade, but a rather a

legal reasonable instrument for those States oriented towards a

prudent approach when the environment or health are threatened by

a possible risk and scientific uncertainty.

65 A. Herwig, The Precautionary Principle, cit., 305. 66 “The science-based approach to regulatory decision-making is questionablesince science is not only ‘heavily contested’ but the risk assessmentmethodologies typically adopted also have significant limitations. (I. Scoones,Science, Policy and Regulation: Challenges for Agricultural Biotechnology in Developing Countries, in U. ofSussex Inst. of Dev. Studies, Working Paper No. 147, 2002, 15). (…) In practice ‘soundscience’ is not sound because ‘conventional risk assessment approaches are oftenill-equipped to deal with multiple criteria and incommensurability, wherescientific uncertainties, indeterminacy and ignorance prevail’ (Ibid., 9). In hisview, ‘standard risk assessment procedures are usually based on the assessmentof a limited number of criteria where technical assessments are seen to besufficient’ due to ‘limited budgets, staff and skill shortages and short-timeframes’ (Ibid., 9). Risk assessment procedures are therefore only able ‘to lookat relatively short-term impacts’, and the hope is that ‘longer term and broaderscale impacts will be picked up through monitoring later on’ (I. Scoones,Regulatory Manoeuvres: The Bt Cotton Controversy in India, n. 1, U. of Sussex Inst. of Dev. Studies,Working Paper No. 197, 2003, 34)”, J.M. Migai Akech, Developing Countries, cit.,277.

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