The EC-Biotech Case: Global v. Domestic Procedural Rules in Risk Regulation: The Precautionary Principle

Poros project 2005-2007: Eu-India Economic Cross Cultural Programme,

European Public Law Series, Vol. LXXXIV, December 2006

Dario Bevilacqua

The Precautionary Principle in GMO Regulations: a vertical and

horizontal comparison∗

Table of contents

1. Introduction

2. The EC- Biotech case: global limits for regional and national administrations

3. Interpretation, application and scope of the precautionary principle in European GMOs’

regulation.

4. The precautionary principle in Indian environmental regulation

5. A vertical comparison with the Agreement on the application of Sanitary and Phytosanitary

Measures

6. A vertical comparison with the Cartagena Biosafety Protocol

7. Conclusive observations

1. Introduction.

There is not a common and unanimous view about the status, as well as the scope and the

definition of the precautionary principle[1] in the global framework of law[2]. There is not an

objective, univocal and binding definition, but rather different interpretations and applications,

enacted in several legal orders.

Among the different approaches at the principle at stake, one in particular is to be considered and

will be supported in the following text: the precautionary principle applies as a general procedural

principle which expands jurisdiction and discretional regulatory powers of public authorities in

limited areas, characterized by scientific uncertainty and risk probability[3], providing the

administrations and the judges with a methodological criterion to balance and evaluate all the

involved rights and interests[4].

In determined fields, such as protection of health or the environment, authorities’ rule-making

can neither be simply the execution of ordinary or treaty-based law, nor of scientific rulings: the

former is often too static and «slow» to keep track of evolving technology; while the latter have

actually revealed unable to provide univocal, objective or pure (free from will) solutions for the

administration of risky activities[5]. In certain fields public administrations are demanded to use

wider discretion, stretching the rule of law and balancing all the interests involved, but this might

lead to phenomena of arbitrariness or abuses of powers and, for instances, to disguised protectionist

measures affecting international trade.

The field of genetically modified organisms’ regulation is a significant example, as it 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”[6]. In such a multi-dimensional area, ruled

by indeterminacy and affecting several conflicting interests, a shared use of precaution has often

been invoked. However, the principle at stake revealed to have 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 law[7].

For the mentioned reasons the article will not only focus on horizontal comparisons among

states’ different regulations, but also, adopting a vertical-view approach, on the likening between

national, supra-national and global regimes. The analysis will stress on the increasing development

of global procedural rules which, as an extra-national rule of law, restrict the discretion of domestic

administrations, setting new uniform and harmonized limits based on international agreements (§

2). If in a globalized world such phenomenon appears logic and justified, in order to establish

common regulations, it also reveals to be too rigid, constraining, and even unfair in areas where

scientific uncertainty over potential risks, different legal approaches and conflicting socio-economic

interests require a flexible, participated and wide-discretional administration. In this way stays the

precautionary principle, as a “fact-value complex”[8] which, embodying empirical and teleological

assessments, acts as a procedural rule directed to guide public policy in risk regulation.

The principle at stake will be analyzed in its definition, application and scope in the European

Union (§ 3); in the Union of India (§ 4); in the provisions of the SPS Agreement (§ 5) and of the

Cartagena Biosafety Protocol (§ 6). Finally, despite all the different definitions and interpretations

of the precautionary principle one common feature will be maintained: its procedural nature,

capable to affect jurisdiction, increasing discretional powers of decision upon the domestic

authorities, and fostering a pluralistic approach in the regulation of fields characterized by

heterogeneity and multi-dimensionality. The precautionary principle will thus reveal as a general

principle of global administrative law, applying to all those sectors where a complete

harmonization, based on legal certainty and sound science, is not possible and neither desirable,

whilst national authorities’ discretion should be prevailing in order to provide a more accountable

and impartial regulation of risk.

2. The EC- Biotech case: global limits for regional and national administrations

In September 2006, the Dispute Settlement Panel of the WTO issued its final Report on the EC-

Biotech case[9]. Compared with the interim report, submitted to the parties in February 2006, the

adjudicative body made one relevant change in regard of its previous ruling: claiming that the so

called de facto moratorium[10] towards genetically modified organisms had not yet ceased to exist,

it demanded the EU to put its measure into conformity with the provisions of the Agreement on the

application of sanitary and phytosanitary measures (SPS Agreement). However, in both the

decisions, “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”[11]. The EC moratorium is

indeed “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 States) and the Commission”[12]. The European moratorium was in fact not found in

violation of substantive norms of the SPS Agreement (art. 2.2, 2.3, 5.1, 5.2, 5.5, and 5.6 ), but it was

considered unlawful under the procedural norm of Art 8 and Annex C(1)(a), requiring to complete

the operational and approval procedures “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 violation of WTO law, 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 two main features, which are in a rational relationship:

1. it has the effect to influence and orient the discretional policies of national and regional

administrative authorities in the regulation of risk concerning GMOs; 2. all the three contested

measures were found to be unjustified in accordance with the scientific requirements of the SPS

Agreement and by the exclusion of the precautionary principle’s application.

1. 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 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 of disguised

protectionism, restricting global commercial transactions.

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[13].

According to the Biotech decision, despite the lack of a substantive international standard[14] on

the matter of GMOs, public administrations have still to abide by global procedural rules: “to

respect global constraints regarding the procedural aspects of their activity”, which “limit the purely

national scope of administrative laws and increase the degree to which national administrations are

subject to the rule of law, both national and global”[15]. The European mechanism of authorization,

although foreseen in the general law of the EU (directive no. 18/2001) and enacted in respect of the

provisions of the Treaty establishing the European Community, was found to be unlawful under

WTO law, and it will have to be put into conformity with the applicable international regulation.

The described «top-down rule of law» does not concern only the external activities for which the

States bound themselves with an international treaty, but it also directly affects the internal

ones[16]: “global regulatory regimes”[17], as the WTO and its court-like body (the DSB)[18],

constrain national authorities, determining or influencing, inter alia, national policies which had

historically been established by sovereign representatives or responsible national administrative

bodies (parliaments, ministries, regulating authorities), diminishing citizen’s sovereignty and their

accountability powers[19]. The problem is particularly evident in the case of the application of the

SPS Agreement in respect to national protection of health. “Though health and safety measures are

not primarily trade issues, they have come to be regulated at the WTO because they can be used as

barriers to trade. This makes good sense from a trade perspective, but it also brings the WTO into

conflict with domestic decisions in areas that have traditionally been within the exclusive domain of

sovereign governments”[20].

In addition, the issue of biotechnology perfectly exemplifies the problem. GMOs are new

products still covered by a high degree of scientific uncertainty[21]; they are not yet produced and

traded in Europe (as in many other Countries[22]); they have a strong multidimensional impact,

which would orient the development and the regulations of several sectors of the society[23], such

as traditional or organic agricultural productive methods[24]. Several national States and the 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 approach, 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 case at issue.

2. The second main feature of the Biotech decision is to be seen in the analysis of the three

contested measures: all of them 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

principle[25] either through the provision of Art 5.7 of the SPS Agreement, or through the

application of the Cartagena Biosafety Protocol, in accordance with Art 31 (3)(c) of the Vienna

Convention on the Law of the Treaties[26].

The strong influence entailed by WTO laws over national or regional administrations, and the

problems of democratic deficit it implies[27], 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-related trade barriers. 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. According to this

mechanism, in case of a dispute among WTO members, 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 risk.

In the weakness of science and of «crystallized» law, the precautionary principle, interpreted as a

general administrative principle affecting the scope of the rule of law, could serve as a legal

instrument to redistribute regulatory powers in case of scientific uncertainty, moving them from the

centre to the periphery, so reducing the gap between the decision-makers and the decision-

recipients, and increasing pluralism and democracy[28] in certain fields of the “global arena”[29].

3. Interpretation, application and scope of the precautionary principle in European GMOs’

regulation.

The first act of the European regulatory framework concerning GMOs was issued in the

beginning of the 90s. During the last fifteen years, several legislative acts followed, covering also

related legal disciplines[30]. For reason of space and scope the analysis will be mainly stressed on

the precautionary principle as applied in Directive n. 18/2001, and on the way it interacts with

harmonization and trade-oriented policy inside the Community.

One of the main characteristics of the first Directive on GMOs (Dir. n. 90/220) was the

«horizontal» method provided for the decision-making orientation: decision could not be just

imposed by the Community, as it also had to assure Member States’ participation. The main

purpose was to harmonize all the relevant provisions of the Member States on this matter, in order

to reach a high level of environmental and health protection, without compromising the free

movement of goods (Preamble and Art 1[31]). To ensure this twofold objective the Directive

established a complex procedure of co-administration[32] involving Member States’ and

Community’s authorities. In addition it implied mutual recognition: once a Member State

authorized a GM product to be placed on the market then it could be traded freely in the entire

Community. However, Directive n. 220 revealed not to be «green» enough[33] and was thus

replaced by the more environmental-oriented Directive n. 18/2001, which followed EC’s

ratification of the Cartagena Bio-safety Protocol[34] and, increasing harmonization, provided a

more complete legislation on the subject.

In addition to the two main purposes – “to protect human health and the environment” and “to

approximate the laws of the member states” (Preamble, recitals 5 and 7 and Art 1, Dir. n. 18/2001),

also shared by Directive no. 90/220 – the Preamble of the new Directive presents other three

indirect objectives that have been considered necessary to reach the first two. These «secondary

purposes» are: to create a post-marketing monitoring system and traceability at all stages of their

placing on the market (Preamble, recitals 42 and 43, Art 4(6), 19(3)(f) and 20, and Annex IV); to

inform and involve the public, already in the authorization procedure (recital 46 and Art 24); to

inform the final consumers through a compulsory labelling (recital 40 and Art 13(2)(f), 19(3)(e), 21,

26 and Annex IV (8)). By the words used by the legislator it is clear the concern to foresee, already

in the Preamble, procedural mechanisms and guarantees, not only to reach the main goals of the

Directive, but also to ensure all the constituencies of the Union with a transparent organization,

participated proceedings, and forms of accountability and administrative controls, in a field which,

as noted before, affects several socio-economic interests, implying also serious health concerns.

Directive n. 18 relies directly on Art 95 of the Treaty, as a harmonizing legislation. However, it

also entails provisions and norms, provided to establish a balance between market needs and the

protection of the environment, in accordance with Art 6[35] and 174-176 of the Treaty, and

between trade and consumers’ health protection.

The authorization procedure for placing a GM product in the market is regulated by Part C of the

Dir. 18/2001/EC. It involves the participation of all the competent authorities of the member

Countries and demands the fulfilment of numerous strict environmental requirements (risk

assessment upon the producer; approval of the scientific and ethical committees; authorization of

national competent institutions and so forth, Art 13 Dir. n. 18) before the placing into the market, in

conformity with the two primary objectives of the Directive. In addition, the procedural mechanism

creates a composite and multinational system of decision, which involves the Commission,

scientific and ethical agencies of neutral experts, and Member States’ authorities (Art 14 – 30, n.

18). The competent subjects for risk assessment and risk management have, “in the implementation

of the rules, a role that sometimes is not simply executory in nature”[36]. These authorities, in fact,

moreover being executers, participate to the mechanism of decision. They influence it and they

contribute to the choice about the level of protection or of precaution to adopt: they are, at the same

time, policy-makers and policy-recipients[37].

The Directive foresees several procedural mechanisms to ensure an impartial and democratic

decision. For what concerns transparency, for instance, Art 9, provides for a double mechanism of

citizens’ information: the norm requires national States to inform the public when there has been a

proposal, so that the interested ones will be able to participate to the process[38]; at the same time it

foresees that also the Commission makes available to the public the information contained in the

system of exchange of information between the Commission and the competent authorities[39].

Then Art 20 requires the result of monitoring to be carried out in transparency; clear rules of

transparency and openess are finally also required by Art 29, concerning the ethic assessment.

The system created with the mentioned Directive is consistent with Art 95; it relies on objective scientific findings, and aims to reach an almost complete degree of harmonization among the members. Nonetheless, at the same time, it also foresees mechanisms of transparency and civil society participation; it takes into account the opinion of ethical committees; States have the power to partecipate to all the phases of the decision-making procedure and to adopt a stricter approach through the safeguard clause (Art 23); while the whole mechanism of authorization is informed by the precautionary principle. The system of regulation thus is not centralized, technocratic or sectoral-interests oriented. On the contrary it provides several mechanisms to ensure a pluralistic and impartial decision on such a heterogeneous subject as GMOs.

The precautionary principle fits naturally into the rationale and the objectives of Directive 2001/18. The latter is mentioned by Art 1 and 4: “all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs”. “The use of the terms ‘to avoid’ and ‘might arise’ in this context is open to a broad interpretation and covers ‘any direct or indirect, immediate, delayed or unforeseen effects on human health or the environment’”[40]. Finally the application of the principle is described and exemplified by Annex II B, concerning the principles to follow for the implementation of risk assessment: thus it is applied in the evaluation of the importer/producer application[41]. In the regulation of GM products the principle at stake is used in order to strike a balance between the needs of harmonization and internal market, and the social and environmental interests affected by biotechnology, whenever science provides not to be enough reliable and objective, so that the competent authorities are allowed to choose a prudent approach[42].

A key provision of the GMO Directive, to understand the balance between internal market

harmonization and States’ sovereign freedom to adopt the regulation they consider appropriate, also

through the use of a precautionary approach, is the safeguard clause of Art 23(1). Whenever a GM

product is approved and a Member State has rational reasons, to further restrict its market, it can

rely on this Article, which reads:

“Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a GMO as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory. (…). The Member State shall…give reasons for its decision, supplying its review of the environmental risk assessment, indicating whether and how the conditions of the consent should be amended or the consent should be terminated, and, where appropriate, the new or additional information on which its decision is based”.

In order to justify a stricter restriction (than the decision made upon the procedures regulated by

part C, Dir. n. 18) of trade of GMOs, the Member States have to review the original scientific risk assessment. A definition of the latter is provided by Annex II of Dir. 18/2001[43], but it only refers to articles 4 and 13 of the Directive: how should be interpreted the risk assessment review of Art 23? Considering that safeguard measures restrict internal trade of goods, it is a key concept to understand how far protection of the environment can go and what evidence is sufficient to close national markets. How much must be proven by a member State that wants to restrict trade even after the Community consent? Is it possible to apply the precautionary principle?

Art 23 does not mention the principle at stake. On the contrary it requires new scientific information, based on “detailed grounds”, to demonstrate that the approved good represents a risk to the environment. The phrase “detailed grounds”, however, must be read in conjunction with “new or additional information… affecting the environmental risk assessment”. By the literal interpretation of the norm, the application of the precautionary principle thus is not excluded: as far as the State demonstrates the presence of new scientific findings and their reliability in questioning the previous risk assessment, there will be no need to produce a new risk assessment demonstrating the effective presence of the risk, being sufficient to prove the probability of risk and new uncertainty to justify a more prudent approach (for instance a new divergent and minority scientific report).

Annex II of the Dir. n. 18 provides the principles for the environmental risk assessment, and the precautionary principle is indicated in Section B. However, as noted, the scope of the Annex is limited only to Articles 4 and 13[44]. Nonetheless there are at least two arguments which entail to believe the precautionary principle can be applied also to Art 23.

First of all, the norm at stake does not provide a specific derogatory definition of the risk

assessment requested for the safeguard clause. Although the norm derogates the Directive, because

it is the member states and not the importer, that have to prove that the product cannot be

considered safe, there is no particular restriction or requirement concerning the demonstration of the

probability of risk. The latter will have to be proven after the standard procedure of risk assessment,

demonstrating that the original risk assessment is not able to guarantee enough safety. There are

reasons to believe that also the Member States can enact this procedure, following the same

rationale of precaution, which can be found in Art 4 and in the Preamble (recital n. 43) of the

Directive, to avoid “any direct or indirect, immediate, delayed or unforeseen effects on human

health or the environment (…), which might arise from the deliberate release or the placing on the

market of GMOs”.

Secondly, an interpretation by analogy with article 12 of Regulation 258/97, concerning the same

topic[45], can be usefully adopted. In Case C-236/01, Monsanto Agricoltura Italia SpA and Others

v. presidenza del Consiglio dei Ministri and Others[46], the ECJ stated that the safeguard measure

(as provided by Art. 12, Reg. 258/97) “can be adopted only if the Member State has first carried out

a risk assessment which is as complete as possible given the particular circumstances of the

individual case, from which it is apparent that, in the light of the precautionary principle, the

implementation of such measures is necessary”[47] (emphasis added). According to the latter

interpretation, in case of a safety measure from a Member State, despite a complete risk assessment

is required, this can be made on the available scientific data and it can be interpreted in accordance

with the precautionary principle. Member states are thus entitled with the possibility to rely on the

precautionary principle, although only in the risk management phase, after and on the base of a

scientific risk assessment, justified at least by the possibility of a risk, and on scientific

uncertainty[48].

If the above reasoning is correct and the precautionary principle applies to the further risk

assessment of Art 23, member States would not need to prove the presence or even the likelihood of

a risk, but they can limit their studies to its possibility. They would not need to prove a rational

relation between the feared risk and their measure, as far as the new scientific information

demonstrates the uncertainty about the occurrence and the development of the alleged risk. The

main requirement, however, would be that of the proportionality of the management measure. The

use of precaution shall not be arbitrary[49], as the safeguard measure is to be considered an

exemption to the normal procedure and it is applied to a product that has received consent by the

other States and by the Community: the precautious regulation would be anyway based on a risk

assessment involving new information and balanced with the application of proportionality

principle[50], which would prevail if the stricter approach would not be justified under scientific

uncertainty and risk possibility.

The EC’s GMO regulation is structured in such a way to balance harmonization and free trade

with environment and consumers’ protection. Decisions concerning commercial authorization of

GM products are based on scientific findings, and they are made at a supranational level, where

citizens’ control and sovereignty is rather weak. However, in addition to mechanisms of inclusion

and participation, the authorization procedure does not exclude the possibility to choose a more

prudent approach, left to the discretion of national regulators, but limited and legitimized by the

application of the precautionary principle.

The precautionary principle has been included into the treaty establishing the European

Community at Art 174[51]. It is to be considered one of the main principles in order to attain the

objective of sustainable development[52] and it is the key element to interpret trade restriction to

protect the environment. Besides inspiring environmental and health regulations of the

Community’s institutions, it also gives great freedom to the Member States’ public agencies, which,

on its ground, can reverse the burden of proof and restrict the free movement of certain goods as far

as they are not proven to be safe. The application of this principle has been supported by the

Commission of the European Union in a Communication. With the latter the European institution

underlined the broad scope[53] of the precautionary principle and stated that it “should be

considered within a structured approach to the analysis of risk: risk assessment, risk management,

risk communication. The precautionary principle is particularly relevant to the management of

risk”, although it “should not be confused with the element of caution that scientists apply in their

assessment of scientific data”[54]. This interpretation concerns essentially the discretion of

decision-makers, entitled to have a prudent approach when they face the twofold requisite of a

possible risk and of scientific uncertainty on it: “when there are reasonable grounds for concern that

potential hazards may affect the environment or human, animal or plant health, and when at the

same time the available scientific and technological data preclude a detailed risk evaluation, the

precautionary principle has been politically accepted as a risk management strategy in several

fields”[55]. Even if the risk assessment is unable to prove an effective or likeable risk, a restrictive

measure can still be applied until it has been demonstrated that there are reasonable grounds for a

potential risk and the available scientific findings result insufficient to produce a complete, univocal

and satisfying report to face this risk.

The interpretation of this principle has finally been influenced by numerous decisions held by the

Court of Justice[56], which followed the Commission’s view and considered the principle as a

general binding one[57].

In the European Union and in its Member States[58] the precautionary principle has reached the

status of a general principle of administrative law, which implies the right of every competent

public subject to discretionally evaluate, manage and chose the appropriate level of protection

against a possible risk carried by a particular product, in accordance with the principles of

impartiality[59], reasonability[60] and proportionality[61]. The intrinsic logic of the precautionary

principle is thus one of a procedural nature: it is not a substantive principle to ensure or guarantee

safety and full environment protection. On the contrary it is rather a mechanism, applying in limited

areas and when science is uncertain, serving as a tool for sovereign and accountable regulating

authorities to act through legitimated discretion to evaluate and manage uncertain scientific

findings, so to make a reasonable decision in the open and vaguely disciplined field of risk

regulation.

As GMO administration is considered to be multi-interests oriented and therefore to be

participated at all levels of governance by large and heterogeneous sectors of civil society, it needs

to be held under sovereign control by the final recipients. This occurs through a co-administrative

procedure, through the implementation of mechanisms of transparency and participation, and

through the application of the precautionary principle. The latter implies a motivated choice and a

localization of the decision-making which reduces the gap between policy-makers and policy-

recipients and fosters pluralism, accountability and what has been called “risk democracy”[62].

4. The precautionary principle in comparison with other domestic jurisdictions: the Indian

regulation.

In November 1994 the Pollution Control Board (the Board) of the Indian state of Haryana has

issued a notification to the Municipal Corporation and to builders having interest in the area, setting

the ambient air quality standards for that place. The notification fixes limiting standards of pollution

in respect of sensitive, industrial and residential areas. The norms for sensitive areas are more

stringent than those prescribed for industrial and residential ones and as the tourist resorts of

Badkhal Lake and Surajkund in the State of Haryana have been considered to be “sensitive”, the

Board recommended that “no construction of any type shall be permitted now onwards within 5

km”, with a view to control pollution and save environment in the vicinity. The Municipal

Corporation, the Haryana Urban Development Authority, and all the subjects affected by the act,

have contested this decision, asking for modification/clarification of the above-quoted direction[63].

In front of the Supreme Court, where the case was finally concluded, the plaintiffs had contended

that banning construction within that zone was arbitrary, because not based on sufficient technical

reasons. According to the directions issued by the Government of India under the Environment

Protection Act, the construction could at the most be banned within 200 to 500 meters and these

standards had been applied by the Government of India in the coastal areas. However, the Court did

not agree with this interpretation, stating that “the functioning of ecosystems and the status of

environment cannot be the same in the country. Preventive measures have to be taken keeping in

view the carrying capacity of the ecosystems operating in the environment surroundings under

consideration”[64], then it stressed on the socio-economic importance which Badkhal and

Surajkund lakes have. To support its argument, the Court referred to the principle of sustainable

development, defining it as “part of the law of the land”[65]. Furthermore it observed that two main

components (“essential features”[66]) of the mentioned principle have also gained binding force in

the national legal system, namely the precautionary principle and the polluter-pay principle. The

Court defined the former in the context of municipal law: “(i) environmental measures - by the State

Government and the statutory authorities - must anticipate, prevent and attack the causes of

environmental degradation; (ii) where there are threats of serious and irreversible damage, lack of

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

degradation; (iii) the ‘onus of proof’ is on the actor or the developer/industrialist to show that his

action is environmental benign”[67]. The reasoning of the adjudicating tribunal stems from the

interpretation of Articles 21, 47, 48-A and 51-A (g) of the Constitution of India[68], which “gives a

clear mandate to the State to protect and improve the environment and to safeguard the forests and

wildlife of the country”[69]. Therefore, the Court rejected the requests of the claimants, even if the

contested act was not based on objective scientific evidence and allowing great discretion to the

public authorities, who, also for future decisions have the right and the duty to establish, on a case-

by-case basis and considering also non scientific or technical reasoning, which measure is to be

taken to enforce an appropriate protection of the environment[70].

In T.N. Godavarman Thirumalpad v. Union of India (UOI) and Ors[71], the Supreme Court of India was called to decide on a temporary inhibition of the mining activities performed by the Kudremukh Iron Ore Co. Ltd. on an area close to the Kudremukh National Park, a forest where there are among 18 internationally recognized “hotspots” for biodiversity conservation in the world. The Court, as it was held in previous legal doctrine on environmental law, relied on Articles 21, 47, 48-A and 51-A (g) of the Constitution of India. Among those it stressed the attention on Art 21 and 51-A (g). As the former protects the “right to life[72]” as a fundamental right, the Court stated that “there is a constitutional imperative on the Central Government, State Governments and bodies like municipalities, not only to ensure and safeguard proper environment but also an imperative duty to take adequate measures to promote, protect and improve the man-made environment and natural environment”[73], so implying a general constitutional duty, for public authorities, to observe environmental principles. More interestingly, the Court underlined that “Article 51-A(g) imposes ‘a fundamental duty’ on every citizen of India to protect and improve the natural ‘environment’”[74]. Stressing on the citizens’ duty to protect environment the Court suggested an indirect de facto constitutionalization of the precautionary principle, through the interpretation of Art 51-A(g), and based on public administration’s power, to demand private individuals to prove the safety of a good or of a production. The application of the precautionary principle, as the duty of a proper demonstration of safety, to be carried by the producer, manufacturer or importer of a potentially hazardous substance, implies a switch of the burden of proof[75], not only in front of a Court, but also concerning the administration and the individuals. In environmental and health related matters the former, as far as produces a prima facie demonstration of risk uncertainty, can require private individuals to carry the burden of a risk assessment and to demonstrate the safety of an activity or of a good, maintaining, for itself, the task to monitor and evaluate the evidence, and then to issue the final decision (for instance on authorization). In this way the responsibility (and the costs) for the obligation to protect the environment, relies primarily on the individuals compelled to observe the “fundamental duty to improve the natural environment” (Art 51-A(g), Indian Constitution), and only secondarily on the administrations[76]. In addition to the Court’s findings it is to note that the Environmental Protection Act (EPA), which affects also genetically modified organisms regulation, and was issued by the Ministry of Environment and Forests (MoEF) on the 23rd of May 1986, implicitly embodies a precautionary approach. First of all the EPA requires limitation of substances that “may be or tend to be”[77] injurious to the environment (Section 2). Secondly it empowers the central government to use all the necessary means to “lay(ing) down procedures and safeguards for the prevention of accidents which may cause environmental pollution and remedial measures for such accidents” (Sec. 3 (2)(vi), emphasis added). The words used in the Act imply a certain discretion left on the competent regulating authorities: according to the letter of the norms, uncertainty and theoretical possibility about risk can be used to consider a substance to be a potential environment pollutant. Being the administration to “take all such measures as it deems necessary or expedient for the purpose of protecting and improving the quality of the environment and preventing, controlling and abating environmental pollution” (Sec. 3 (1)), it is entitled to issue a ban or a restriction of the spread of certain substances or products, without producing a rigorous scientific proof; or to require, to the producer, an explicit demonstration of the safety of the product[78].No Indian legal text gives a definition of the precautionary principle. The one adopted by the Supreme Court presents the following characteristics. At points (i) and (iii) it foresees, respectively, the authorities’ discretional power to establish which measures adopt in order to “anticipate”

environmental degradation, and the parallel “onus of proof” for the producer/industrialist to demonstrate the safety of the product. At point (ii) the Court reproduced the definition of the principle as provided by Art 15 of the 1992 Rio Declaration on Environment and Development. This definition is commonly considered a very broad one, as it implies a compulsory (“should not be used to avoid…”) cautious approach for the competent authority and leaves the interpretation open, in regard of the degree of prudence. While the specification of “serious and irreversible damage” provides a limit to its scope, the word “threat” and the phrase “lack of full scientific certainty” leaves a considerable space for a discretional interpretation, either on the probability of risk, either on the quantity or quality of the evidence required to science on the matter.

The first Act concerning biotechnology in India was the Sixth Five Year Plan 1980-85[79].

Afterwards the Government updated the regulation, in conformity with the EPA and the

international Agreements, among which the Rio Declaration and The Cartagena Biosafety

Convention. The regulation consists of several rules/guidelines, issued by different ministries,

which govern various aspects of GMOs, although so far none of them have covered trade[80]: the

1989 Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms,

Genetically Engineered Organisms or Cells, issued by the Minister of Environment and Forests

under the EPA; the Recombinant DNA Safety Guidelines, 1990, and the subsequent Revised

Guidelines for Research in Transgenic Plants, 1998, prepared by the Department of Biotechnology

(DBT)[81]. These rules, however, cover the entire spectrum of activities relating to genetically

modified organisms[82].

Although the Indian regulations provide risk assessment criteria which are not distinct from

western models, 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’ (DBT Guidelines 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” [83] can be issued to a

transgenic crop, and it implies a costs/benefits analysis already in the scientific assessment of the

risk. As it was previously noted, this is still 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).

While the “precautionary principle” is not explicitly mentioned either in Indian biosafety

regulations, or in other positive legal texts, it can be assumed that it permeates the Indian legal order

at several levels and matters (including regulation of GMOs), as a fundamental and general

compelling principle for public authorities and as a decisional criteria, entailing discretion for the

administration and safety requirements for the producers. In the biotechnology field precautionary

decision-making is understood as going beyond scientific uncertainties about quantifiable

ecological and health impacts, and the clearest precautionary actions on LMOs have been mainly

related to socioeconomic concerns[84]. The precautionary approach in the current framework of

biosafety in India is slightly different than the one used in developed countries. “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”[85].

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”[86]. 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”[87], 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 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”[88].

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. As this legal instrument can be used already in the phase

of risk assessment and includes also social and economical evaluations, it presents drawbacks and

advantages. On one side the vagueness and the wideness of the application of the precautionary

principle while empowering public administrations, diminishes citizens’ rights of participation or of

influence on the decision-making process[89]; in addition the legal discipline provides mechanisms

of decision which might be found unlawful, under WTO Law, because not adequately justified

through objective scientific assessments. On the other side the principle at stake implies the

necessity, supported by constitutional provisions, to reserve decisions about certain issues to the

case-by-case discretion of public authorities, stressing on the insufficiency and inadequacy of

relying exclusively on science; and on the political connotation of this decision-making, in order to

maintain a balance between socioeconomic and environmental stakes.

Comparing the precautionary principle as enacted in the European legal framework to the way it

is implemented in India, two differences and one similarity can be found. The first difference stems

by the fact that in the Indian legal order no legislative or administrative act mentions or defines the

precautionary principle. The latter was born and characterized by the Supreme Court as a general

and fundamental principle of the law of the land, but did not find any space in statutory law, as in

EU. Secondly, the precautionary principle, as interpreted by Indian institutions, implies also

economic and social considerations as direct components of the risk assessment, while in Europe

the cautious approach concerns essentially health (or the environment) and a broader cost/benefit

analysis is performed only in a secondary moment, in the management phase of the procedure. With

regard to the similarity, in Indian legal system the increment of public authorities’ discretion in

uncertain risk regulation follows the same rationale of the EU approach: in both legal orders the

precautionary principle acts as a general procedural principle affecting jurisdiction and rule-making

powers on multi-interests subjects which cannot be regulated only upon scientific findings, and

foreseeing reasonable evaluations and decisions in situations of risk regulation governed by

uncertainty. The last aspect is indeed quite significant: apart from the inner substantial definition of

the precautionary principle, in both countries it applies as a procedural one, giving administrative

authorities the discretional powers to choose the regulation of risk they deem to be more reasonable

and cost effective.

5. The vertical comparison with 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 Agreement[90]. According to the latter, the restriction of the market of GM

products for health concerns 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)[91]. The only exception to this model is disciplined at Art 5.7, which

admits national trade-restrictive measures not based on risk assessment if four cumulative

requirements can apply: (1) the measure is imposed in respect of a situation where “relevant

scientific information is insufficient”; and (2) adopted “on the basis of available pertinent

information”; however, such a provisional measure may not be maintained unless the member

which adopted the measure (3) “seek[s] to obtain the additional information necessary for a more

objective assessment of risk”; and (4) “review[s] the … measure accordingly within a reasonable

period of time”[92]. The Panel defined the content of Art 5.7 as an autonomous right of the Member

States, to adopt the measure they consider more appropriate, to protect their citizens from health-

related risks[93]. 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 satisfy all the requirements of

the provision[94]. 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”[95]. 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 risk[96].

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”[97]. Therefore, giving for granted 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 measure[98] 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 can only be based on science), both from that of risk management (which cannot be used as

a justification without an appropriate risk assessment), so considerably reducing the application of

the qualified right embodied in Art 5.7[99], also when risk assessment’s results are so ambiguous to

require a discretional decision among more options in the management phase.

The Panel finally observed that “the adequate risk assessment”[100] 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”[101]. This interpretation,

which is in a progressive continuum with the previous legal doctrine on the subject[102], 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 States, these are not free

to determine their appropriate levels of protection, as foreseen by the Preamble and by Art 4[103] 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 principle[104], 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

uncertainty[105].

Differently from the above interpretations of the WTO’s provisions, risk management plays a

decisive role in the approval phase of the EC biotech regulation. This phase must be based on a

scientific risk assessment, but the risk manager enjoys a considerable discretion, as “the regulation

of risk has to be exercised in conformity with that (precautionary) principle”[106] (emphasis

added). This approach finds its justification in the considerable scientific uncertainty over the GM

products and is as well supported by a guideline of the ad hoc task force on biotechnology of the

Codex Alimentarius Commission, which states that “risk managers should take into account the

uncertainties identified in the risk assessment and implement appropriate measures to manage these

uncertainties”[107].

According to the Commission of the European Union, whereas the scientific uncertainty does not

allow a complete assessment of the alleged risks, it is up to the managers, using their discretion and

relying on the precautionary principle, to establish which is the sustainable quantity or quality of

risk for the society: “it is generally accepted that defining the level of acceptable risk is a normative

decision that belongs to the democratically elected and accountable institutions of a State”[108]. The

limit of the risk manager’s discretion is not to be found in science, but in the rationale of the

precautionary principle, i.e. in a proportionate and reasonable prudent approach and in the

accountability of the policymakers[109].

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

the same agreement. The latter is the main difference stemming from the comparison with the

European legal system. Although both the examined legal texts aim at balancing the interests of

trade and harmonization on one side and health (or environmental) protection on the other, they

have a different system of implementation. The European model foresees a «pluralistic

harmonization», with residual powers for the member States to adopt stricter regulations (based on

sound science, or on a precautionary approach). On the opposite, the SPS Agreement, in the dispute

settlement bodies’ view, reduces local discretion, 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.

6. The vertical comparison with the Cartagena Biosafety Protocol

The Cartagena Biosafety Protocol (CBP) entered into force on the 11th of September 2003[110].

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

purpose 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 protection from eventual harmful effects

derived from LMOs), even through the restriction of trade[111].

To reach its objectives, the CBP foresees the use of the precautionary principle[112] (Art 1) and

of the “Advanced informed agreement – AIA” procedure[113]. This one represents the core of the

treaty and it consists of an authorization procedure related to trade of LMOs (“intentional trans-

boundary movement”, Art 7). 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 country of import.

This document must contain all the information about the product, including a risk assessment[114].

Then, the Party of import has to take a decision (Arts 9-10), for which it has four options: 1)

approving the import, with or without conditions, including how the decision will apply to

subsequent imports of the same LMOs, 2) prohibiting the import, 3) requesting additional relevant

information in accordance with its domestic regulatory framework or Annex I, or 4) extending the

period for decision-making (Art 10(3) (a-d)). This decision can be taken in accordance with the

precautionary principle (Arts 10(6) and 11(8)).

The AIA procedure might consist of a trade restrictive tool in the hands of national member

countries[115]. When LMOs trade is at issue, indeed, the importing State can require a risk

assessment from the exporter; if the latter does not 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 WTO[116], 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 application to these phase, leaving a limited possibility only if the risk assessment is

impossible, as required by Art 5.7[117].

Paragraph 9 of the Convention[118] 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. Following 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 uncertainty[119].

“Further, the CPB allows parties to take socio-economic considerations ‘arising from the impact

of [LMOs] on the conservation and sustainable use of biological diversity’ into account in their

decision-making on LMO imports (Art 26). But in doing so they are required to act consistently

with their international obligations”[120]. This provision presents an evident similarity with the

Indian model, as it explicitly allows domestic authorities, which are about to make a decision, to

consider all the socio-economic interests affected by GMOs. However, it is due to underline that the

requirement of acting consistently with international obligations, despite its vagueness, implicitly

entails a reasonable and proportionate approach: the discretional evaluation must be kept into the

limits of international treaty law, so considering other obligations contracted by the State and other

conflicting interests protected by multilateral agreements. Therefore, for this respect, the provision

embodied in Art 26 recalls more the rationale of the European model. In addition, by the words of

Art 26 (1) – “socio-economic considerations arising from the impact of LMOs on the conservation

and sustainable use” it can be implied that the scope of socio-economic consideration must be

limited to potential biodiversity loss and not more generally.

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

participate[121], it is still coherent with the 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 demonstrated[122], contrast with the provisions

of the SPS Agreement and might be used as disguised restriction of trade[123]. And this is the

reason why the main producing Countries of genetically modified organisms (Argentina, Canada

and USA) did not ratify the Protocol. 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[124]. 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

regulation[125]. And it shows how, in the global arena, two legal instruments might present two

opposite faces (environment and trade) of the same drawback: i.e. sectoriality.

Finally, although in the CBP the precautionary principle is conceived in a very broad sense and

might be used as a way to restrict trade imposing high precautionary requirements over the other

member States, it does not depart from the common feature observed in other legal orders: also in

this text it is seen as a procedural principle which increases public authorities’ discretion over the

uncertain regulation of risk and affects their decision-making procedure requiring a broader

investigation than the science-oriented one. In comparison to the EC model it is to mention a

general lack of counterbalances, either of a substantive nature (sectoriality of the agreement which

mainly hangs towards environment at the detriment of trade), or of a procedural one, as the system

might allow arbitrary decisions in violation of the principles of reasonability and proportionality.

7. Conclusive observations.

Although the indeterminacy of the legal status of the precautionary principle, above all in

international law, some general remarks and a common understanding can still be theorized.

The core of the precautionary principle consists of its procedural and teleological nature.

Combining the principles of impartiality, proportionality and reasonability, it indicates, through the

twofold requirement of scientific uncertainty over risk-possibility, when public authorities have the

discretion to adopt a prudent policy[126]. 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 uncertainty[127]. “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”[128].

The precautionary principle influences the rule of law principle as it increases the discretionary

power of the “administration of risk”. At the same time global harmonization, due to international

trade law, has modified the application of the rule of law, bringing it at an extra-national level,

outside the domestic borders. In several areas of law, still characterized by scientific uncertainty and

by different legal and political orientations, domestic administrations are no more able to make

discretional decisions in accordance to multifaceted interests and constitutional values, but their

choices is conditioned by international agreements, technical reports or other (predominant)

member states’ policy.

The precautionary principle, more than a principle to protect environment or than a strict rule

which constrains authorities to cowardly activities[129], is a flexible procedural and teleological

principle[130] which affects jurisdiction in the global arena, entitling domestic authorities with

wider discretional powers and providing them with extra-scientific decisional criteria in cases of

risk possibility and scientific uncertainty. At the same time it limits these powers through

reasonableness and proportionality requirements, and by incrementing the responsibility in

regulating certain fields, which are «escaping» national parliaments’ jurisdiction[131] but cannot be

left to non-accountable decision-makers[132]. It implies a costs/benefits analysis and it is “capable

of fostering accountability vertically between levels of governance and, paradigmatically, between

the politics of anxiety and the politics of risk”[133]. 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 would accept unreliable scientific

justifications without considering social and long-period drawbacks[134]. Precaution does not mean

“safe”, it rather means “prudent”. Prudence is not a guaranty of safety or health, it is a choice. Is

this choice still available for national administrations? Are they free to regulate certain sectors of

the law which are not only traditionally left to state’s sovereignty, but which also imply such

political connotations that necessitate of a discretional (but also participated, transparent and

accountable) body deciding upon them? This freedom seems to be precluded in the area of health

protection, when it might have a negative impact on global trade. However, this sovereignty-

restriction is proven to be due to a narrow interpretation of the SPS Agreement, which reduces and

frustrates the scope and the rationale of Art 5.7, as it stems from a different literal and teleological

interpretation of the norm.

The application and interpretation of the precautionary principle appears crucial in the

heterogeneity characterizing certain areas of law, which have gained a global impact, such as

genetically modified organisms’ regulation. If interpreted in accordance with the EC’s approach and

surrounded by mechanisms of participation and accountability, the precautionary principle would be

increasing pluralism in global governance of uncertainty-featured areas, in favour of a flexible,

principles-oriented, and wide-discretional administration. Such discretion would then allow the

different constituencies to have a way to maintain effective domestic sovereignty on certain issues.

A common legal application of the precautionary principle would foster pluralism[135], without

encouraging nationalism, as far it is accompanied by other procedural principles, it is subjected to

WTO bodies’ judicial review, and the competent administrative authorities guarantee transparency,

participation and, more general, accountability to all (national as well as foreign) affected

constituencies.

∗ The author wish to thank the professors B.G. Mattarella and F. Fonderico for their comments and remarks at a first version of this article.

[1] The literature on the precautionary principle, although recent, is already very broad. Among the others see J. Tickner, C. Raffensperger, and N. Myers, The precautionary principle in action. A handbook, First Edition, Science and Environmental Health Network, 2005; N. De Sadeleer, Environmental Principles. From Political Slogans to Legal Rules, Oxford, Oxford University Press, 2002; P. Harremoes & oth., The Precautionary principle in the 20th Century. Late lessons from Early Warnings, London, Earthscan, 2002; T. O’Riordan, J. Cameron, A. Jordan, Reinterpreting the precautionary Principle, London, Cameron May, 2001. For what concerns the italian literature in particular see F. De Leonardis, Il principio di precauzione nell’amministrazione di rischio, Milano, Giuffrè, 2005; G. Manfredi, Note sull’attuazione del principio di precauzione in diritto pubblico, in Diritto Pubblico, 2004; L. Marini, Principio di precauzione, sicurezza alimentare e Organismi geneticamente modificati nel diritto comunitario, in Il diritto dell’Unione Europea, 2004; F. Bruno, Il principio di precauzione tra diritto dell’Unione Europea e WTO, in Diritto e giurisprudenza agraria e dell’ambiente, 2000; Id., Principio di precauzione e organismi geneticamente modificati, in Rivista di diritto agrario, 2000, III, 223.

[2] For «global framework of law» it is to be intended that complex set of laws applying and interacting at a global scale: not only treaty-based international law, but also direct-executing acts of regional organizations, transboundary-effect domestic regulations and that set of rules, which has its origin in extra-national institutions, has a binding effect over private individuals inside the States, and has been called “global administrative law”. “We are witnessing the emergence of a ‘global administrative space’: a space in which the strict dichotomy between domestic and international has largely broken down, in which administrative functions are performed in often complex interplays between officials and institutions on different levels, and in which regulation may be highly effective despite its predominantly non-binding form”, N. Krisch and B. Kingsbury, Introduction: Global Governance and Global Administrative Law in the International Legal Order, in EJIL, 17, 1, 2006, 1. On this issue see S. Cassese, Il diritto amministrativo globale: una introduzione, in Riv. Trim. Dir. Pub., 2005, R. B. Stewart, Global Administrative Law, Lectio Magistralis Honoris causa, Conferimento della Laurea “Honoris Causa” in Giurisprudenza al Professor Richard B. Stewart, Università degli Studi di Roma “La Sapienza”, Rome 13th of June, 2005; R.B. Stewart, B. Kingsbury, N. Krisch, The emergence of Global Administrative Law, in Law and contemporary problems, 68, 3-4, 2005.

[3] In areas such as environment or health administration, the way to face, regulate and minimize risk has been central for competent public authorities. A general expression covers all these kinds of policies: «risk regulation». This phrase has gained an increasing popularity, due to the development of technological discoveries, which have entitled the administration with the task to monitor and regulate all the progresses of science, in order to avoid or limit all the possible dangers which the

former could cause. It is the regulatory activity proper of the “Risikogesellschaft” (“Risk society”), see U. Beck, Risikogesellschaft. Auf dem Weg in eine andere Moderne, Suhrkamp, Frankfurt am Main, 1986, 14, (the english version is Risk Society — Towards a New Modernity, London, Sage, 1992).

[4] “Il principio di precauzione assume il ruolo di pre-principio di carattere metodologico per effettuare il tradizionale bilanciamento tra beni costituzionalmente protetti”, F. De Leonardis, Il principio, cit., 322.

[5] “Where ignorance or indeterminacy are important, and the stakes are considerable, a new methodology is needed which they (Funtowicz and Ravetz) call ‘post-normal’ or ‘second-order’ science. Conventional science is still involved but vigorous participational democracy is required to provide legitimacy”, T. O’Riordan, J. Cameron, A. Jordan, Reinterpreting, cit., 43.

[6] S.D. Murphy, Biotechnology and International Law, in Harward International Law Journal, 2001, 1.

[7] This is one of the argument against the precautionary principle. For instance some authors have argued that the principle has “an elusive concept” and therefore has a questionable status in international law; others stated that “at present… (it) is not a term of art”, respectively L. Gundling, The Status in International 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 of International Law, in Handl (eds.), 1 Yb. Int’l Env.L., 1990, 23. Both quoted by T. O’Riordan, J. Cameron, A. Jordan, Reinterpreting, cit. 116.

[8] J. Stone, From Principles to Principles, in The Law Quarterly Review, 97, 1981, 224.

[9] EC – Measures Affecting the Approval and Marketing of Biotech Products (WT/DS/291, 292, and 293), Interim Report of the Panel, Geneva, 7 February 2006 (hereinafter EC-Biotech). The final Repot has been officially issued during the publication of this text.

[10] The first, of three contested measures by the complaining parties (Argentina, Canada and the United States), is the European de facto moratorium, towards genetically modified organisms. From 1998 to 2004 the European Communities did not approve any import of such products. According to the complex approval procedure, regulated before by the Directive 90/220/EC and now by the Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 (together with Regulations 258/97/EC; 1829/2003; and 1830/2003), no GM product (imported or internally produced) has been authorized to be placed in the European market during that time. This was the main argument alleged by the complaining parties, to bring the issue in front of the DSB. “The US submits that the EC’s adoption of the moratorium is inconsistent under the WTO Agreement (…). While members are allowed to maintain approval systems, the procedures under that system must be undertaken and completed without undue delay”, EC – Biotech, First written submission by the USA, Geneva, April 21, 2004, 1; “Argentina is consistently not questioning the Community directives and regulations per se, but their implementation”, EC – Biotech, First written submission of Argentina, Geneva, April 2004, § 195.

[11] N. Bernasconi-Osterwalder and M.J. Oliva, Center for International Environmental Law (CIEL), EC-Biotech: Overview and Analysis of the Panel’s Interim Report, March 2006, 5.

[12] EC-Biotech, Interim Report, § 7.1282.

[13] One example of the described trend is the global common regulation of food safety measures, which are notably intertwined with global trade. The international food safety standards, issued by the Codex Alimentarius Commission, were, before the Marrakech Agreements, soft-law norms with which the States could simplify and harmonize international food products transactions. After 1995 they became quasi-binding substantive norms, which induce national States to constantly conform their food regulations with the international community. These regulations, issued after a complex procedure which sees member states participating as decision-makers and decision-recipients, are

aimed at “protecting the health of the consumers” and “ensuring fair practices in the food trade” (FAO/WHO, Statutes of the Codex Alimentarius Commission, Rome – Geneva, 1961/62, Art. 1; see www.fao.org, www.who.int). So that health protection must be balanced with trade interests. Moreover, and above all, the SPS Agreement, which is a trade-oriented treaty, directly recalls (at Art 3 and Annex A) Codex’s standards in order to justify national sanitary or phytosanitary measures, encouraging WTO members to conform with the standard to avoid trade restriction. As WTO law has gained an undeniable effective force over its member states, indirectly it confers notable legal strength also to the standards, as the States will prefer to abide by these norms rather than face a dispute in front of the DSB. The standards, despite being soft laws gain binding force when adopted by a different international regime and applied by its bodies. Through this linking technique, defined as “borrowing regimes”, in the legal science (D.W. Leebron, Linkages, “The Boundaries of the WTO”, in American Journal of International Law, n. 96/2002, 14), both the organizations increase their powers, in this sense see S. Battini, Il sistema istituzionale internazionale dalla frammentazione alla connessione, in Riv. Ital. Dir. Pubbl. Comunitario, 2002, 985 – 986. On the issue check also S. Poli, The EC and the Adoption of International Food Standards within the Codex Alimentarius Commission, in European Law Journal, 2004, 616; A. Herwig, Transnational Governance Regimes for Food derived from Bio-Technology and their Legitimacy, in C. Joerges, I. J. Sand and G. Teubner (ed.), Transnational Governance and Constitutionalism, Oxford and Portland Oregon, Hart, 2004, 210 ss.; D. Bevilacqua, The Codex Alimentarius Commission and its Influence on European and National Food Policy, in.European Food and Feed Law Review, n. 1/2006, 3 and so forth; D. Bevilacqua, The Codex Alimentarius Commission: increasing accountability through transparency, 1 and passim, available on line at http://www.iilj.org/global_adlaw/documents/Bevilacqua.doc.

[14] The Codex Alimentarius Commission has created an ad hoc Task force, in order to reach an agreement about common standard on biotechnological foods: Codex Alimentarius Commission, Ad hoc intergovernmental Task Force on Foods derived from Biotechnology, 1999-2003 and 2005-2009, CX/FBT, http:// www.codexalimentarius.net .

[15] S. Cassese, Shrimps, Turtles and Procedure: Global Standards for National Administrations, IILJ Working Paper, 2004/4 (Global Administrative Law Series) (available at http://www.iilj.org/papers/2004/2004.4%20Cassese.pdf), at 3.

[16] “Legitimacy may be derived from consent (…). However, consent is a problematic source of legitimacy for the WTO. In particular, it does not adequately address critics who fear that when states have consented to delegate some of their sovereign power to the WTO to act in the domain of international trade, the consent has, in fact, spilled over to a far wider range of social concerns, such as health and safety issues”, P.M. Gerhart, The two constitutional visions of the World Trade Organization, in University of Pennsylvania Journal of International Economic Law, Spring 2003, 3.

[17] R. B. Stewart, Global Administrative Law, Lectio Magistralis, cit., 25 and so forth.

[18] The SPS Agreement deals with fast evolving matters and it is conceived in a «frame Agreement», which sets general substantive and procedural rules for member states in order to issue SPS measures not in conflict with WTO law. For this reason, the interpretation given by the DSB organs has always been a creative and constructive one, with a strong effect on Countries’ policies. That is why “at the WTO, policymaking occurs through the dispute settlement process”, A.T. Guzman, Food Fears: Health And Safety At The WTO, in Virginia Journal of International Law, Fall 2004, 5.

[19] “Among the most common critiques of globalization is that it increasingly constrains the ability of democratic communities to make unfettered choices about policies that affect the fundamental welfare of their citizens, including those of health and safety, the environment, and consumer protection. Traditionally, free trade rules were about constraining border measures such as tariffs and quantitative restrictions on imports. Increasingly, however, such rules include requirements and

constraints addressed directly to domestic regulation”, R. Howse, Democracy, Science, and Free Trade: Risk Regulation on Trial at the World Trade Organization, in Michigan Law review, June 2000, 2329.

[20] A.T. Guzman, Food Fears, cit., 16.

[21] GMO is “an organism, with exception of human beings, in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating and/or natural recombination”, Directive n. 18/2001. Genetic modification consists of the use of modern techniques of genetic enhancement, which allow the improvement of biological organisms beyond that which is attainable using natural selection and controlled breeding. What has arisen most debate is the so-called trans-species genetic modification: this allows gene transfers that would be impossible with traditional breeding. In particular, transgenic modifications involve modifying cell information by artificially transferring the genes from one species into another. Most of the concerns and of the scientific disputes relate to this last technique. “Technologically based uncertainty stems from factors that include the inherent imprecision of currently employed rDNA techniques, the use of powerful, often viral, promoter sequences in genetic constructs, and the generation in GMOs of novel proteins to which humans and animals have never been exposed; scientific uncertainty also results from the still-considerable ignorance of the composition, and serious inadequacies in studies conducted to assess the potential health and environmental impacts of GMOs”, EC – Biotech, Amicus Curiae Brief, Geneva, June 1st, 2004, 4 – 5.

[22] “While the estimated global area of transgenic or genetically modified (GM) crops continues to increase the vast majority of acreage (99 per cent) remains confined to just four countries, namely the US, Argentina, Canada and China”, H. Baumüller, Domestic Import Regulations for Genetically Modified Organisms and Their Compatibility with WTO Rules, TKN paper available at http://www.tradeknowledgenetwork.net/publication.aspx?id=587, 33.

[23] “The principal contemporary concerns (regarding GMOs) may be placed in six general categories: (…) A) equitable concerns regarding the patenting of GM products (…); 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.

[24] According to some, the market restriction to GM products, while being a trade barrier potentially decreasing consumers’ choices, might, on the contrary, increase their protection from the risk of a biotechnological monopoly, which would as well affect their freedom of choice. “Critics argue that a widespread LMO technology in agriculture will benefit a few large multinational companies and allow them to establish a global cartel to the detriment of the world’s consumers and farmers. An antitrust suit has already been filed on this ground in 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.

[25] N. Bernasconi-Osterwalder and M.J. Oliva, EC-Biotech, cit., 37 – 38.

[26] Both the issue of the “undue-delay” , both that of risk assessment could have been justified through the application of the precautionary principle. However the Panel excluded this possibility as the requirements of Art 5.7 were not satisfied and The Cartagena Biosafety protocol could not be applied to the Complainants as non-ratifying Countries, EC-Biotech, §§ 7.1500 – 7.3405.

[27] “A democratic deficit is considered to be occurring when ostensibly democratic organizations or institutions (particularly governments) are seen to be falling short of fulfilling the principles of democracy in their practices or operation. The phrase was coined by UK Member of the European Parliament Bill Newton Dunn in a pamphlet in the 1980s”, at http://en.wikipedia.org/wiki/Democratic_deficit. For what concerns extra-national binding regulations, such as the WTO, the problem of democratic deficit has been arisen by several exponents of the legal science. These decision-making bodies are often unaccountable, and surely not legitimized through electoral or parliamentary systems, but rather through international

agreements. The executory phase is evidently prevailant over the other ones (legislative and adjudicative), at detriment of the accountability of the decision makers. The latter, in particular, is to be considered as the main drawback in the global regimes’ lack of democratic guarantees.

[28] “By explicitly noting the limits of scientific determination, the precautionary principle legitimates public political determination of these issues, in some sense democratising international environmental law and its implementation”, T. O’Riordan, J. Cameron, A. Jordan, Reinterpreting, cit. 119. In this sense see also A. Herwig, The Precautionary Principle in Support of Practical Reason. An Argument Against Formalistic Interpretations of the Precautionary Principle, in C. Joerges & E.-U. Petersmann (eds.), Constitutionalism, Multilevel Trade Governance And Social Regulation, forthcoming with hart Publishing, Oxford, 2006, at 326 where she holds: “because the precautionary principle does not predetermine what the right justification will be, it creates a possibility for decision-makers to draw on justifications that have the recognition of those affected by their decisions. The precautionary principle is, therefore, a way of dealing with reasonable pluralism about question of risk”.

[29] “The public arena phenomenon manifests itself in the global legal space as well as in the national one. By this I mean that there are multiple levels of government, in potential conflict between each other (international organizations and national administrations) and also interested parties, which can exploit the differences between the regulators by playing off one against the other”, S. Cassese, Shrimps, Turtles, cit., 15.

[30] Directives 90/219/EEC (Confined utilization of genetically modified micro-organisms, modified in 1994 and 1998 by Directives 51 and 81 EC) and 90/220/EEC (Deliberate release into the environment of genetically modified organisms, abolished by Dir. 18/2001/EC); Regulation 258/97/EC of the European Parliament and of the Council (Novel foods and food ingredients); Directive 18/2001/EC (Deliberate release into the environment of genetically modified organisms); Regulations 1829/2003 (Genetically modified food and feed) and 1830/2003 (Traceability); Regulation of the European Parliament and Council n. 1946/2003 (Transboundary movements of GMOs).

[31] “The objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment”, article 1, Dir. no. 90/220.

[32] The old procedure foresaw a notification by the importer, with all the information related to the product, on which there was an assessment made by the competent authority of the member state (Art 11); in case of negative opinion the product was rejected, in case of positive opinion the member state forwarded the dossier to the Commission (Art 12); on receipt of the dossier referred to in Art 12, the Commission immediately forwarded it to the competent authorities of all Member States together with any other information it has collected, then if all the authorities did not reach an agreement the decision was taken by the Community and in case of favorable opinion the first member state had to allow the GM product (Art 13).

[33] The approval system of Dir. no. 90/220 provided a balance between the powers and competences of the States and of the Community, which had the last word only in case of disagreement among the members. However, the system was not «green» enough and presented several notable drawbacks, which led to a new regulation. The Directive was based on Art 95 of the Treaty of Rome, according to which the environmental issues have a secondary relevance, in regard to the predominant aim of the common market (on the subject, see L. Marini, Principio di precauzione, cit., 46 and so forth.; T. Christoforou, The Regulation of genetically modified organisms in the European Union: The Interplay of science, law and politics, in Common Market Law Review, 2004, 679 and so forth). In the system provided by Dir. n. 90, the procedure of risk assessment (R.A.) was done only by the competent authority (C.A.) of the receiving member states (and not by the importer of the products) and no R.A. was foreseen before the procedures leading to the first-time consent. In the standard procedure only the national C.A. was responsible for granting consent, without the involvement of the other states’ authorities. There was no involvement of the

committees for their technical support and no application of the precautionary principle. In addition the safeguard clause left a narrow margin to those member states willing to adopt a more environmental friendly approach to the GMOs and the safeguards themselves were submitted to a procedure of control and authorization by the European institutions. Finally, the Directive did not “include common/harmonized criteria on the risk assessment to be performed and did not provide for any post market surveillance measures”, EC – Biotech, First European Communities Submission, Geneva, 17 May 2004, 57.

[34] At Montreal on 29th of January 2000, check also Ibid., 58.

[35] “Environmental protection requirements must be integrated into the definition and implementation of the Community policies and activities referred to in Article 3, in particular with a view to promoting sustainable development” (art. 6, TEU). This statement (so called “the integration principle”), in particular, is important because it opens the interpretation of secondary legislation to a more environment-friendly approach and it “leads to a general obligation on the Community institutions to reach an integrated and balanced assessment of all the relevant environmental aspects when adopting other policy”, J. H. Jans, European Environmental Law, The Hague, Europa Law Publishing, 2000, 18.

[36] T. Christoforou, The Regulation, cit., 679 – 680.

[37] The procedure is started by a member state, which can immediately interrupt it (but informing all the other members) if the national competent authority gives a negative opinion about the product (Art 14 – 15, cit. Dir.). States are also partecipating to all the steps of the proceudre: first directly, submitting objections (ex Art 15, 17 and 20, cit. Dir.); later indirectly trough their representatives in the Committees; and finally in the Council of Ministers for a qualified majority decision in case of a negative opinion of the Regulatory Committee (Art 30, cit. Dir.). The Community, on the other side, leads the procedure through all the different steps (apart from the beginning) and has the competence to take the final decision, either after a favorable opinion of the regulatory committee, or for inactivity of the Council.

[38] “Member States shall, without prejudice to the provisions of Articles 7 and 25, consult the public and, where appropriate, groups on the proposed deliberate release. In doing so, Member States shall lay down arrangements for this consultation, including a reasonable time-period, in order to give the public or groups the opportunity to express an opinion”, Art 9, par. 1.

[39] “The Commission shall make available to the public the information contained in the system of exchange of information pursuant to Article 11”, Art 9, par. 2.

[40] T. Christoforou, The Regulation, cit., 645.

[41] The risk assessment is on behalf of the manufacturer that has to demonstrate the safety of the product, in an adequate and sufficient way (in accordance to the interpretation given by the Commission of the European Union, in Communication on the precautionary principle, Brussels, 02.02.2000, COM 2000, 3 and so forth) and on a case-by-case basis (for each individual product). The described requirement entails a corollary of the precautionary principle: the principle of preventive authorization; through it the EC legislator switched the burden of proof on the producer. On this issue see F. Bruno, Principio di precauzione e organismi, cit., 224.

[42] It is to mention that, by now, no case has been brought in front of the ECJ, for violation of Directive n. 18/2001.

[43] “The objective of an e.r.a. is, on a case-by-case basis, to identify and evaluate potential adverse effects of the GMO, either direct, and indirect, immediate or delayed, on human health and the environment which the deliberate release or the placing on the market of GMOs may have. The e.r.a. should be conducted with a view to identifying if there is a need for risk management and if so, the most appropriate methods to be used”, Dir. 18/2001, Annex II, A. Objective.

[44] “This Annex describes in general terms the objective to be achieved, the elements to be considered and the general principles and methodology to be followed to perform the environmental

risk assessment (e.r.a.) referred to in Articles 4 and 13”, Annex II, A, Dir. N. 18/2001.

[45] Regulation n. 258/1997/CEE of the European Parliament and of the Council deals with Novel foods and food ingredients and it is part of the legal framework concerning GM products.

[46] C-236/01, Monsanto Agricoltura Italia SpA and Others v presidenza del Consiglio dei Ministri and Others, 2003, European Court reports 2003, I-08105, available at

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=62001J0236&model=guichett.

[47] Ibid. § 114.

[48] This interpretation was also followed by the ECJ in the conflicts aroused under Directive 220/90, which did not mention the precautionary principle and did not give great freedom to the Member States. However, the ECJ “has repeatedly upheld national regulations that deviated from EU norms. (…). Stricter national regulations that have trade-restricting effects are usually upheld by the ECJ as long as they do not discriminate between imports from different EU countries, do not favour domestic over foreign producers, and can be justified from a scientific viewpoint (at a minimum in terms of the precautionary principle)”, T. Bernauer, Genes, Trade, and Regulation. The seeds of conflict in food biotechnology, Princeton & Oxford, Princeton University Press, 2003, 108 – 109.

[49] “Where action is deemed necessary, measures based on the precautionary principle should be, inter alia: proportional to the chosen level of protection, non-discriminatory in their application, consistent with similar measures already taken, based on an examination of the potential benefits and costs of action or lack of action (including, where appropriate and feasible, an economic cost/benefit analysis), subject to review, in the light of new scientific data, and capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment”. Commission of the European Union, Communication, cit., 5

[50] Art. 5 TEU: “Any action by the Community shall not go beyond what is necessary to achieve the objectives of this Treaty”; “Measures based on the precautionary principle should be proportional to the chosen level of protection”, J. H. Jans, European Environmental Law, cit., 33. The principle of proportionality must be applied by national and European authorities, keeping in consideration all the conflicting interests at stakes. In environmental regulation, for instance, there must be a proportion between environmental protection and the common market, between states’ policy and harmonization. An example can be seen in a decision of the Commission concerning art. 95 of the Treaty of Rome, where this norm has been interpreted to be “in the light of the precautionary principle”, see Commission Decision 1999/832, OJ 1999 L 329/25 (Dutch creosote).

[51] Art 174 of the Treaty of the European Community foresees the precautionary principle at paragraph 2, although it does not give a definition of it. However, at paragraph 3 it reveals its procedural nature: “the Community (indeed its institutions) shall take into account available scientific and technical data, (…); the environment conditions (…); the potential benefits and costs of action or lack of action (…); the socio-economic development”. The precautionary decision i.e. decision about risk when there is a potential hazard and science is not able to ensure a safe remedy is therefore not free or arbitrary. It must rely on a complete analysis, not only concerning with environmental interests, but also including costs/benefits analysis, scientific data available, socioeconomic consequences.

[52] In addition to Arts 6 and 174 of the TEU, the precautionary principle has been recognized as a principle of international sustainable development law by the United Nations. See UN Doc. A/57/329, New Delhi Declaration of Principles of International Law Relating to Sustainable Development, 31 August, 2002.

[53] “Although the precautionary principle is not explicitly mentioned in the Treaty except in the environmental field, its scope is far wider and covers those specific circumstances where scientific evidence is insufficient, inconclusive or uncertain and there are indications through preliminary objective scientific evaluation that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the chosen level of protection”, Commission of the European Union, Communication, cit., 10.

[54] Ibid., 3.

[55] Ibid., 9; this double-premised interpretation finds a confirmation also in international soft law: “in order to reach environmental protection, the precautionary approach may be implemented when there are two main factors involved – 1) When there is a presence of risk or potential hazard, and 2) Where there is a lack of scientific certainty on the extent of the potential damage or effect on human health and the environment from an action, product, or process”, OECD, ‘Uncertainty and Precaution: Implications for Trade and Environment’, Joint Working Party on Trade and Environment, September 2002, 38-41.

[56] Case 178/84, Commission v. Germany, at p. 1274: “In so far as there are uncertainties at the present state of scientific research, it is for the member states, in the absence of harmonization, to decide what degree of protection of the health and life of human they intend to assure”; Case C-157/89, Commission v. Italy (1991); Case C-435/92, Association pour la protection des animaux savauges (1994); Case C-180/96 United Kingdom v. Commission (1998), paragraph 99: “Where there is uncertainty as to the existence or extent of risks to human health, the institutions may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent”; and Case C-121/00, Reference for a preliminary ruling: Bezirksgericht Innere Stadt Wien – Austria (2002).[57] “Il carattere vincolante del principio di precauzione in materia ambientale, essendo espressamente previsto nell’art. 174 del Trattato, è dunque pacificamente accolto dalla Corte di Giustizia (…). Sia le istituzioni comunitarie, sia la Corte di Giustizia hanno precisato che si tratta di un principio di applicazione generale”, F. Bruno, Il principio di precauzione tra diritto, cit., 564

[58] It is to be noted that the precautionary principle has by now permeated the EC member states’ legal systems. For instance, in Italy it is included among the principles governing the administrative process of law, as Art 1 of the Italian law Statute which lays down the general principles of administrative process of law (Legge 7 agosto 1990 n. 241 cited at note 21,) explicitly recalls the principles of the European Law as applying on the Italian administrative process of law (On the issue see F. De Leonardis, Il principio, cit., XIV). In the French legal system the precautionary principle assured the level of constitutional law, after the modification of Art 5 of the French Consitution: on the 1st of June 2004 the Assemblée national approved (328 votes in favor against 10), followed by the Sénat on the 24th of June 2004 (174 votes in favor, 93 against and 45 abstained) the new text of Art 5 of the Constitution: “Lorsque la realization d’un dommage, bien qu’incertaine en l’état des coinnaissances scientifiques, pourrait affecter de manière grave et irreversible l’environnement, les autorités publiques veillent, par application du principe de precaution, à l’adoption de mesures provisoires et proportionnées afin d’eviter la realization du dommage ainsi qu’à la mise en œvre de procédures d’évaluation des risques encourus”. On the precautionary principle in French legal system check A. Martin, Precaution et evolution du droit, in Recueil Dalloz Sirey, 1995, II, 299; F. Bruno, Il principio di precauzione tra diritto, cit., 572.

[59] The principle of impartiality is currently considered, for instance in Italian administrative law, in conjunction with the principle of good administration. This means, inter alia, that when the public administrations are called to issue a decision, they are required not only to avoid any sort of privilege or favoritism, but also to balance all the interests involved, to consider the main purpose of the act they are required to issue and to choose for the most effective, economic and fair solution. The principle at stake implies a discretional evaluation made by the competent authorities. This is thus not arbitrary, but it is limited by the rule of law and by a reasoned motivation which the administration is compelled to provide (Art 3, of the Italian law Statute which lays down the general principles of administrative process of law: Legge 7 agosto 1990 n. 241, Nuove norme in materia di procedimento amministrativo e di diritto di accesso ai documenti amministrativi). On this interpretation of the principle of impartiality see C. Franchini, L’organizzazione, in S. Cassese, Trattato di diritto amministrativo, diretto da S. Cassese, Diritto amministrativo generale, Milano, Giuffrè, Vol. I, 2004, 266: “i principi di imparzialità e, soprattutto, di buon andamento impongono di operare le scelte organizzative con strumenti non rigidi, come la legge, idonei a garantire la possibilità di adeguare le strutture alle esigenze che di volta in volta si prospettano”.

[60] The concept of reasonability is central either in the regulation of risk or in the precautionary principle. In the former it is to be seen as the administration’s approach to act in accordance with a legitimate and justified (by the reasonability of the risks expected) discretion, rather than through a

free (and so potentially arbitrary) discretion. In the second the reasonability is required to demonstrate that the precautionary decision has been made on a reasonable evaluation of the risk involved, an “appréciation raisonable” (N. De Sadeller, Les principles du polluer-payeur, de prevention et de précaution, Bruxelles, Bruylant, 1999, 155), which considers and gives reasons of all the involved facts and interests, on the issue see F. De Leonardis, Il principio di precauzione, cit., 129 and so forth; G. Manfredi, Note sull’attuazione, cit., 1091.

[61] As it will be demonstrated in the following sections precaution is in intimacy connection with the principle of proportionality, mainly because it implies a cost-benefits analysis and a balanced evaluation between risk and prudence. In addition legal science considers the precautionary principle to be derived by the proportionality one, in a parental-kind relationship, F. De Leonardis, Il principio, cit., 151 ss.; according to F. Ewald, Philosophie politique du principe de précaution, in F. Ewald, C. Golliers, N. De Sadeleer, Le principe de précaution, Colecciòn Que sais-je?, PUF, Parìs, 2001, 56 “le principe de precaution est indissociable du principe de proportionnalitè. Il repose sur un art des pondérations”.

[62] F. Ewald, Philosophie politique, cit., 55. The decision is not just imposed by a central technocratic and unaccountable body, on the contrary it stems from domestic (or even local) subjects which will have to respond for their prudent action.

[63] M.C. Mehta v. Union of India, WP 4677/1985 (1996.10.11) (Delhi Land Use Case: Badkhal Lake and Surajkund), 10/11/1996 M. C. Mehta Vs Union of India and Others, Writ Petition (Civil) No. 4677 of 1985 (N. P.Singh, Kuldip Singh JJ), 11.10.1996.

[64] Ibid., § 6.

[65] Ibid., § 8. The Court also quoted Vellore Citizens' Welfare Forum v. Union of India [(1996) 5 SCC 647: JT (1996) 7 SC 375] where this concept was outlined (SCC pp. 657-60, §§ 10, 11, 14 and 15).

[66] Ibid., § 8.

[67] Ibid., § 8.

[68] “21. Protection of life and personal liberty—No person shall be deprived of his life or personal liberty except according to procedure established by law; 47. Duty of the State to raise the level of nutrition and the standard of living and to improve public health—The State shall regard the raising of the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties and, in particular, the State shall endeavour to bring about prohibition of the consumption except for medicinal purposes of intoxicating drinks and of drugs which are injurious to health; 48A. Protection and improvement of environment and safeguarding of forests and wild life—The State shall endeavour to protect and improve the environment and to safeguard the forests and wild life of the country; 51A. Fundamental duties—It shall be the duty of every citizen of India (…)(g) to protect and improve the natural environment including forests, lakes, rivers and wild life, and to have compassion for living creatures”, Constitution of India, 26th

of November, 1949, as modified by the Constitution 42nd Amendment Act of 1976, which introduced Articles 48A and 51A. On the issue see S. Mane, Constitutional Provisions, in N.L. Mitra, V. Chitnis and M.K. ramesh, Environmental Management, Constitution and the Law, Bangalore, National Law School of India, 1998, 44 and so forth.

[69] M. C. Mehta v. Union of India (1996), § 10.

[70] Ibid., §§ 8 and 10.

[71] Supreme Court of India, T.N. Godavarman Thirumalpad v. Union of India (UOI) and Ors., IA No. 670 of 2001 in WP (C) No. 202 of 1995, decided on 30.10.2002.

[72] The word life must be interpreted in an open way: “the expression ‘life’ assured in Article 21 of the Constitution does not connote mere animal existence of continued drudgery through life. It has a

much wider meaning which includes right to livelihood, better standards of life, hygienic conditions in workplace and leisure”, Supreme Court of India, Consumer Education & Research Centre v. Union of India, (1995) 3 SCC 42.

[73] Ibid., § 17.

[74] Ibid., § 17.

[75] This interpretation was confirmed in Sujatha vs A. Prema and others (2005.06.20), High Court Of Kerala 20th June, 2005, Reported in Indian Law Reports 2005 (3) Kerala: “It is to be noticed that while the inadequacies of science have led to the precautionary principle, the said precautionary principle in its turns, has led to the special principle of burden of proof in environmental cases where burden as to the absence of injurious effect of the actions proposed, -- is placed on those who want to change the status quo (Wynne, Uncertainty and Environmental Learning, 2 Global Envt. Change 111 (1992) at 123). This is often termed as a reversal of the burden of proof, because otherwise in environmental cases, those opposing the change would be compelled to shoulder the evidentiary burden, a procedure which is not fair. (…). 11. The Precautionary Principle suggest that where there is an identifiable risk of serious or irreversible harm, including extinction of species, widespread toxic pollution in major threats to essential ecological process, it may be appropriate to place the burden of proof on the person or entity proposing the activity that is potentially harmful to the environment”.

[76] To support its environmental thesis, the Court also stated that as India acceded to the Cartagena Convention on Biosafety “is, therefore, necessary for the Government to keep in view the international obligations while exercising discretionary powers under the Conservation Act unless there are compelling reasons to depart therefrom”, Ibid., §§ 43 – 51.

[77] Environmental Protection Act, New Delhi, 23 May 1986.

[78] “The precautionary principle means the principle of establishing a duty to take such measures that anticipate, prevent and attack the causes of environmental degradation, even where there is not yet scientific proof that the environment is being armed”, A. Goyal, Harmful Biotechnological Innovations-led genetic erosion: legal choice between "Precautionary" and " Necessary" Principles, in Indian Journal of International Law, 42, 1, 2002, 52; on the precautionary principle in Indian law, see also G. Singh, Legal Status of Pecautionary Principle in Environmental Jurisprudence, in National Capital Law Journal, 5, 2000, 36; and S.C. Shastrri, Environmental Law in India, Delhi, Eastern Book Company, 2005, 53 – 56.

[79] India, Sixth Five Year Plan, 1980-85, New Delhi, Planning Commission, 326

[80] “The agricultural biotechnology industry has expanded in India in a major way. The number of agricultural firms engaged in the agricultural biotechnology sector has gone up from 85 in 2001 to 132 in 2003. There were in total 176 biotechnology firms in India, of which almost 48 per cent were agriculture based companies, 24 per cent with an interest in health related medical activities and 28 per cent were with varied interests, including in environmental biotechnology. In 2003, the number of biotechnology firms was 401, with healthcare firms showing the largest increase, overtaking the number of agricultural biotechnology companies”, S. Chaturvedi – L. Chawii, Biosafety Protocol, International Trade and Agricultural Biotechnology: Policy Inferences for India, RIS woking paper, RIS-DP # 99, New Delhi, September 2005, 13; “Though India established the bio safety guidelines way back in 1989, till now no commercial trials of GM crops have been allowed”, S. Chaturvedi, Status and Development of Biotechnology in India: An Analytical Overview, RIS working paper, RIS-DP # 28, New Delhi, September 2002, 31; “Notwithstanding this comprehensive coverage, GMO use in India to date has occurred largely in contained conditions, with some deliberate releases in the form of experimental field trials. Approvals for commercialization of GMOs or food safety assessments of processed materials have not yet been required. Furthermore, no transgenic products have knowingly been imported into the country for

commercial use. Thus, while the biosafety regulatory framework in India is broad in its coverage, its functioning in practice remains in a state of evolution and development”, A. Gupta, Governing Biosafety in India: The Relevance of the Cartagena Protocol, Belfer Center for Science and International Affairs (BCSIA), Discussion Paper 2000-24, Environment and Natural Resources Program, Kennedy School of Government, Harvard University, 2000, available at http://environment.harvard.edu/gea, 13 – 14.

[81] There are some proposed policies as well, such as the Seed Act, 2004 by the Ministry of Agriculture; the Draft Food Safety and Standards Bill, 2005 by the Ministry of Food Processing Industries; the Draft Plant Quarantine Order, 2003 by the Ministry of Agriculture and Cooperation, and the Prevention of Food Adulteration Act and Rules by the Ministry of Health, on the subject see S. Chaturvedi – L. Chawii, Biosafety, cit., 17 and so forth.

[82] The provisions includes “research involving genetically modified organisms, as well as genetic transformations of green plants, rDNA technology in vaccine development, and large-scale production and deliberate/accidental release into the environment of organisms, plants, animals and products derived from rDNA technology”, DBT (Department of Biotechnology), Recombinant DNA Safety Guidelines. Ministry of Science and Technology, Government of India, New Delhi, 1990, Art 1.

[83] A. Gupta, Governing Biosafety, cit., 15.

[84] In a period between 1998 and 1999, the National Bureau of Plant Genetic Resources (NBPGR) under the Indian Council for Agricultural Research, impeded the Monsanto Corporation to introduce its Bt cotton into the market, suspecting it was a so called “terminator gene” (a technology entails modification to a crop such that it produces sterile seed which must be bought every year); a similar decision was taken, in the same period, against genetically modified soybean, coming form the USA, as no previous authorization had been issued on the product. Indian biosafety regulations now call for one mandated entry point into the country for all imports of transgenic material, whether for research, field testing or commercial use. This entry point is to be the National Bureau of Plant Genetic Resources (NBPGR) under the Indian Council for Agricultural Research. On these episodes see A. Gupta, Governing Biosafety, cit., 18 – 19 and 27: “‘socially precautionary’ actions have included restrictions on imports of transgenic commodities following the soybean controversy, and restrictions on future import of terminator technology following the controversy about its alleged field-testing in India. In both these cases, there were no environmental or human health rationales offered for restrictions on imports. Instead, attention to the issue in the media rather than assessment of potential hazards to human health from transgenic soybean fueled the decision not to import such commodities, whilst the terminator controversy was centrally concerned with socioeconomic issues of dependence on foreign technologies and farmer’s rights”.

[85] S. Chaturvedi – L. Chawii, Biosafety, cit., 18.

[86] Michelle K. McDonald, International Trade Law and the U.S.-EU GMO Debate: Can Africa Weather This Storm?, 32 Ga. J. Int'l & Comp. L. 501, 504 (2004), 522.

[87] 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, 270. On the relationship between agricultural economy and environmental degradation in India see R.N. Chakraborty, Linkages between Income Distribution and Environmental Degradation in Rural India, in S.T. Madsen (ed.), State, Society and the Environment in South Asia, 165 and so forth.

[88] A. Gupta, Governing Biosafety, cit., 27.

[89] “The two central regulatory committees under the department of biotechnology and ministry of environment, the RCGM and the GEAC, both consist of scientists from public sector institutions as well as government representatives. Scientific disciplines represented include genetics, molecular biology and the agricultural sciences. There are, however,

almost no social scientists and no members of the general public involved. Representatives from industry and non-governmental organizations can be invited to participate in their individual capacities as experts, although there is no formal requirement to involve them, and petitions by NGOs to participate in particular sessions have in a few cases been turned down. Also, these two central committees, but particularly the Department of Biotechnology’s RCGM, are composed of public sector scientists who are themselves engaged in transgenic research. This results in the not unfamiliar situation of scientists regulating themselves rather than an autonomous agency regulating research in this area. Equally important, public sector scientists are also regulating their private sector counterparts, who are often further along in developing similar transgenic crops. As seen later, this public-private information sharing dynamic has implications for reliance on information sharing as a central risk mitigation strategy in this area”, Ibid., 15 – 16.

[90] EC-Biotech, §§ 7.147 – 7.429.

[91] “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 to be assessed”, Australia – Measures Affecting Importation of Salmon, Report of the Appellate Body, WTO Doc. WT/DS18/AB/R (Oct. 20, 1998), available at http:// www. wto.org .

[92] See Appellate Body Report, Japan – Measures affecting the Importation of Apples, WT/DS45/AB/R, 10 December 2003 (hereinafter Japan - Apples), § 89.

[93] “Thus, we find the general test provided by the Appellate Body in EC – Tariff Preferences to be applicable, and application of that test leads us to the conclusion that Article 5.7 should be characterized as a right and not an exception from a general obligation under Article 2.2. In other words, we consider that in the same way that ‘Article 3.1 of the SPS Agreement [...] excludes from its scope of application the kinds of situations covered by Article 3.3 of that Agreement’, Article 2.2 excludes from its scope of application the kinds of situations covered by Article 5.7. As we will explain further below, characterizing Article 5.7 as a right rather than as an exception has implications for the allocation of the burden of proof”, EC-Biotech, § 7.2960 (footnotes omitted).

[94] Ibid., § 7.2989.

[95] Ibid., § 7.2986.

[96] “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 proof that other scientific theories leading to different assumptions about risk are wrong”, A. Herwig, The Precautionary Principle, cit., 318.

[97] EC-Biotech, § 7.3056.

[98] In Appellate Body Report, EC – Measures Concerning Meat and Meat Products (1998),WTO Appellate Body 1998, WT/DS 48/AB/R (hereinafter EC-Hormones), the AB required a rational relation demonstrated in the risk assessment, then it demanded a rational relationship with risk management, denying discretion to the managers and unifying the two phases (when it stated that “it is not only risk ascertainable in a science laboratory operating under strictly controlled conditions, but also risk in human societies as they actually exist, in other words, the actual potential for adverse effects on human health in the real world where people live and work and die”, § 187), so that in front of the Court the discretional phase of management could not be used, being absorbed by the scientific evaluation of risk. On these issues see R. Howse, Democracy, cit., 2337.

[99] The DSB has always given a narrow interpretation of this provision, reducing it to a scientific demonstration, and denying the application of the precautionary approach. The interpretation and the scope of the precautionary principle 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 of them the AB excluded its application.

[100] Japan - Apples, cit., § 182.

[101] EC-Biotech, cit., § 7.3226.

[102] “Relevant scientific evidence”: the scientific data “will be ‘insufficient’ within the meaning of Article 5.7 if the body of scientific evidence does not allow, in quantitative or qualitative terms, the performance of an adequate assessment of risks as required under Article 5.1”. Further the AB

supported its argument by stating that: “the application of Article 5.7 is triggered not by the existence of scientific uncertainty, but rather by the insufficiency of scientific evidence. The text of Article 5.7 is clear: it refers to ‘cases where relevant scientific evidence is insufficient’, not to ‘scientific uncertainty’. The two concepts are not interchangeable”, Japan – Apples, §§ 179 and 184.

[103] “Further the use of harmonized sanitary and phytosanitary measures between Members, (…), without requiring Members to change their appropriate level of protection of human, animal or plant life or health” (Preamble); “Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member's appropriate level of sanitary or phytosanitary protection” (emphasis added) (Art 4, Equivalence).

[104] This provision has been defined as the “proportionality test”, which aims at verify “whether the governmental measure under review has an excessive or disproportionate impact on the applicant’s interests”, F. Ortino, From “‘non-discrimination” to “reasonableness”: a paradigm shift in international economic law?, Jean Monnet Working Papers, n. 1/2005, reperibile al sito http://www.jeanmonnetprogram.org/papers, 35.

[105] “As language such as ‘based on’ and ‘take into account’ suggests, the SPS Agreement brings science in as one necessary component of the regulatory process, without making it decisive. Thus ‘sufficient scientific evidence’ arguably refers to the evidence that is needed if science is to play this democratic role in risk regulation, not to some threshold of scientific proof or certainty below which democratic judgements about risk are illegitimate”, R. Howse, Democracy, cit., 2336.

[106] T. Christoforou, The Regulation of genetically modified organisms in the European Union, cit., 682.

[107] Codex Alimentarius Commission, Principles for the Risk Analysis of Foods derived from modern Biotechnology, Rome, CAC/GL 44-2003, 2, available at http://www.codexalimentarius.net/download/standards/10007/CXG_044e.pdf. It is to be added that the mentioned standard was not taken into consideration by the EC-Biotech Panel because it entered into force after the contested implementation of EC regulation.

[108] T. Christoforou, The Regulation, cit., 702.

[109] The discretion of authorities is thus not fully free to become arbitrary. On the contrary it is a form of “legitimate discretion”, the activity of the administration is free from the constraint of the law (and of science), but within its (their) limits”, See G. Anschütz, Kritische Studien zur Lehre vom Rechtssatz und formellen Gesetz, Leipzig, 1891, 53.

[110] The text of the Agreement is available at www.biodiv.org/biosafety/.

[111] L. Boisson de Chazournes and M. M. Mbengue, GMOs and Trade: Issues at Stake in the EC Biotech Dispute, in RECIEL 13, 2004, 3, 290 and so forth.

[112] “The language on precaution in the body of the protocol has been hailed as the first operationalization of the precautionary principle in an environmental agreement. However, examining the language reveals that rather than operationalizing “the” precautionary principle (there is no universally shared version) it represents a mix of existing formulations in other agreements. As I have argued elsewhere, a comparison with other dominant renditions of precautionary decision-making, including Principle 15 of the Rio Declaration and Article 5.7 of the WTO Sanitary and Phytosanitary Measures Agreement, reveals that the Protocol’s language can be differently interpreted to both exceed and not exceed what is allowed for under existing agreements with relevance for LMO trade” A. Gupta, Governing Biosafety, cit., 8 – 9.

[113] “The international community has, through the CBP, recognized that GM products are such that they require their own, distinct authorization procedure. Indeed, for the trans-boundary movement of some LMOs, the CBP requires the parties to follow the AIA procedure”, L. Boisson de Chazournes and M. M. Mbengue, GMOs and Trade, cit., 292.

[114] The procedure is very similar to art 13, EC Directive 18/2001/EC, which is based on the CBP

and also switches the burden of proof: it is the importer/producer which has to show the products are safe.

[115] “While the CPB is an international environmental agreement, it addresses the international movement of ‘living modified organisms’ (‘LMOs’) and therefore impacts trade”, J.M. Migai Akech, Developing Countries, cit., 272.

[116] The exporter has only a prima facie burden of proof as a complaining party, but it is the State which issued the SPS measure that has to justify it, relying on an international standard or proving the likelihood of an ascertainable risk.

[117] However if Art 5.7 is interpreted in combination with Art 4.1 of the same agreement, which foresees the duty for the “exporting Member to objectively demonstrates that its measures achieve the importing Member's appropriate level of sanitary or phytosanitary protection”, an analogous precautious and discretional approach should be implied from the reading of the SPS Agreement, as far as the importing Member can prove that insufficient science is unable to produce an adequate risk assessment. While the two risk assessment procedures are different (the CBP implies a precautionary approach in it and includes risk management as justification for trade restriction), the precautionary approach of article 10.6 CBP (“Lack of scientific certainty due to insufficient relevant scientific information and knowledge”) is written in a very similar way to the provision held in article 5.7 SPS Agreement (“relevant scientific evidence is insufficient… on the basis of available pertinent information”). The main difference is that the former foresees insufficiency as a cause of uncertainty, which, together with a potential threat, is reputed enough to restrict trade. On the contrary the SPS provision, by excluding uncertainty, requires only absolute insufficiency of science to allow a risk assessment for restricting trade. On the relationship between the two agreements see B Eggers and R. Mackenzie, The Cartagena Protocol on Biosafety, in Journal of International Economic Law, 2000, 542; check also N. Bernasconi-Osterwalder, The Cartagena Protocol on Biosafety: a multilateral approach to regulate GMOs, in E. Brown Weiss and J. H. Jackson (eds.), Reconciling environment and trade, Ardsley, N.Y., Transnational Publishers, 2001, 716 – 719.

[118] The Convention is an international Agreement, which was signed in June 1992, and entered into force in December 1993. It counts 188 members, and established and prepared the preparation and ratification of the CBP.

[119] Article 1 of the Biosafety Protocol, states: “In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements”. Furthermore, Article 10(6) of the Protocol states: “Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism in question as referred to in paragraph 3 above, in order to avoid or minimize such potential adverse effects”.

[120] J.M. Migai Akech, Developing Countries, cit., 273.

[121] “The CPB conceptualizes public participation largely in terms of providing information to the public rather than as a ‘strategic opportunity to make informed, legitimate and effective policies’, (D. Glover, Public Participation in National 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 a passive recipient of information about biotechnology, and their ignorance is to be cured through education and awareness-raising activities. Because the public is invited to ‘participate’ only after science has made the value judgments, the space for public participation is circumscribed. The public does not therefore get an opportunity to help frame the scope of regulation”, Ibid., 277. It is to note that Art 23 contains explicit provisions on access to information,

requiring contracting parties to promote and facilitate: public awareness, education and participation concerning safe transfer, handling and use of LMOs in relation to biodiversity conservation. However these requirements, contrary to the WTO model, are left to the Countries’ discretional jurisdiction: “in accordance with their (of the States) respective laws and regulation”. This approach leaves a considerable amount of discretion for governments and does not require changes to a status quo that might be inadequate at present.

[122] EC-Biotech, §§ 7.49 and so forth.

[123] The CBP “is, fundamentally, a trade agreement pertaining to agricultural commodities produced using modern biotechnology that is solely concerned with establishing the rules under which countries can limit imports. (…). This leaves the regulation of imports of these products open to influence by a broad range of protectionist interests that have nothing to do with protection of the environment”, 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.

[124] “The Biosafety Protocol has been established in parta s a counterweight to WTO rules”, N. Krisch, The Pluralism of Global Administrative Law, in EJIL, 17, 1, February 2006, 261.

[125] “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 view concerning sectoriality, from another discipline’s perspective, see also J. Stiglitz, Globalization and Its Discontents, New York – London, Norton, 221 and so forth.

[126] What is written in Rio Declaration or CBP implies a compulsory rationale (“should be avoided”), while the precautionary approach of the SPS is not compulsory, but it must be seen as a procedural and qualified (it must respect the four requirements of art. 5.7) right left to the discretion of domestic decision-makers, in accordance with the principle of good administration (good governance, buona amministrazione). The mere perception of risk is not enough if there is enough science information to control it, but the combination of “mere possibility” and scientific uncertainty (also about its developing or effects) makes the precautionary principle apply.

[127] “When ignorance and incommensurability are acknowledged to be firmly grounded in the science of risk assessment, then it follows that a more broadly-based, pluralistic and epistemologically humble precautious approach is more scientific than traditional narrow risk assessment”, T. O’Riordan, J. Cameron & A. Jordan, Reinterpreting, cit., 82.

[128] J.M. Migai Akech, Developing Countries, cit., 269.

[129] E. Fisher, Precaution, Precaution Everywhere: Developing a ‘Common Understanding’ of the Precautionary Principle in the European Community, in Maastricht Journal of European and Comparative Law, 9/2002, 7.

[130] In the Italian Constitution, for instance, there are several principles structured in a teleological way: the principle of substantial equality, embodied by Art 3, paragraph 2, does not indicate which means must be used to enact its contents; the principle of legality, which can be implied by Art 113 and requires the administration to respect the law does not make clear its scope, without specifying what is to be intended for law; finally also the principle of impartiality and good administration does not foresee an administrative model. On this issues see G. Manfredi, Note sull’attuazione del principio di precauzione, cit., 1097; C. Pinelli, Art. 97, co. 2, Cost., in Commentario della Costituzione fondato da G. Branca e continuato da A. Pizzorusso, La pubblica amministrazione. Artt. 97-98, Bologna-Roma, Zanichelli – Soc. Editrice de Il Foro Italiano, 1994, 212 and so forth; According to S. Cassese, Le basi costituzionali, in Trattato, cit., 222: “il giudice amministrativo, da un lato, verifica il rispetto da parte della pubblica amministrazione del principio di legalità in senso stretto, ossia accerta la sussistenza e l’osservanza delle norme (anche non legislative) attributive e di regolazione del potere. Dall’altro, impone il rispetto di principi di diritto (ad esempio, logicità, proporzionalità e congruità dell’azione amministrativa, ecc.), che non solo non trovano un espresso fondamento nella legge, ma nemmeno sono sanciti da norme positive, perché si traggono dall’ordinamento complessivo”.

[131] Either environmental or health regulation are, nowadays, such global and fast-developing fields, which cannot be disciplined exclusively at the national level, neither through the instrument of detailed and long-termed laws, but rather through fast, impartial case-by-case decisions.

[132] In risk regulation the administration chooses – by using the precautionary principle – which uncertain science is preferable, transforming it in legal certainty. See A. Rullo, Funzione di tutela ambientale e procedimento amministrativo, Napoli, Editoriale Scientifica, 2000, 86.

[133] A. Herwig, The Precautionary Principle, cit., 305.

[134] “The science-based approach to regulatory decision-making is questionable since science is not only ‘heavily contested’ but the risk assessment methodologies typically adopted also have significant limitations. (I. Scoones, Science, Policy and Regulation: Challenges for Agricultural Biotechnology in Developing Countries, in U. of Sussex Inst. of Dev. Studies, Working Paper No. 147, 2002, 15). (…) In practice ‘sound science’ is not sound because ‘conventional risk assessment approaches are often ill-equipped to deal with multiple criteria and incommensurability, where scientific uncertainties, indeterminacy and ignorance prevail’ (Ibid., 9). In his view, ‘standard risk assessment procedures are usually based on the assessment of a limited number of criteria where technical assessments are seen to be sufficient’ due to ‘limited budgets, staff and skill shortages and short-time frames’ (Ibid., 9). Risk assessment procedures are therefore only able ‘to look at relatively short-term impacts’, and the hope is that ‘longer term and broader scale 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.

[135] On this issue see N. Krisch, The Pluralism, cit. in particular at 263 and so forth.