New Technologies, the Precautionary Principle, and Public Participation

Book Chapter

Reference

New Technologies, the Precautionary Principle, and Public Participation

BOISSON DE CHAZOURNES, Laurence

BOISSON DE CHAZOURNES, Laurence. New Technologies, the Precautionary Principle, and Public Participation. In: Thérèse Murphy. New Technologies and Human Rights . Oxford : Oxford University Press, 2009. p. 161-194

Available at:

http://archive-ouverte.unige.ch/unige:8311

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5

New Technologies, the Precautionary Principle, and Public Participation

Laurence Boisson

de

Chazournes

The issue of scientific and technological innovation is not new for the legal arena.

Ever since the industrial revolution, scientific progress has been so fast that the law has often been late in responding to new technological challenges. lndeed, as Weeramamry has pointed out, 'inventions are piling up at a rate which far outpaces the possibilities of legal control. The law is not ready with the appro- priate annory of new concepts to challenge these new weapons of intrusion.'1 This is particularly true for 'new technologies', the progress of which, especial!y in recent years, is faster and more difficult to regulate compared to 'traditional technologies'. In the COntext of the present contribution, the emphasis will be on legal responses to risks posed by new technologies. Ir is accepted however that new technologies may also bting benefits and pose new opportunities-'

There is no widely accepted definition of 'new technologies'. In the relevant literarure (not ooly that of the legal kind), new technologies seem to be addressed in two distinct ways. In a stricter sense. the expression only concems technologies in the domains of communication and information. This definition ^ÎS, we could say. a 'starie' one, because il only covers cenain categories of technologies. In a larger sense, the expression 'new technologies' is used as a synonym of 'higb technology activities', encompassing technologies in the domains of biology, space. communications, computer, and nudea.r activities. This definition rdies on the novelty of the technological means at stake, meaning that a 'new tech- nology' of today will no longer be 'new' in the future, and that, more generally, al! technologies are 'new' when they are fust introduced into sociery. The meaning of 'new' is

mus

^{subject to} evolution and has to be continuously updated. Ir is this latter definition of'new technologies' which is moS! commonly found in legal writings.

•

1 CG. Weeramantry. Justice without Frontiers: Pro"cting HU11Uln Rights in tk Age ufT~chnulogy (1997), ac 72.

2 See further the chapter by Roger Brownsword in this volume.

162 Laurmc< Bollion tk Chazoumtf

Science makes action possible, narnely in the form of new technologies, but onen science is unable to predict the collareral effecrs of actions with suffieient cenainty. Human creativity does not seem ta have limits. As it has been said, 'nos pouvoirs exâdent notre savoir'.3 For international law. this prerucament ficst appeared with respect co nuclear acrivities and then in the environmental area and the field of biorechnology. International law has ro /àce conrrasting values:

on the one band the inrerests ofhumanity and of future generations as served by environmenca1 protection, respect for human righlS, and sovereigruy ovec naruraI resourœs; on the other hand, freedom of scientifie research, free trade, and the prorection of intellecrual propercy righrs.· The International Coun of Justice (ICJ) has poinrcd our this dialecrie of values in the inremarionallegal order:

Throughout the ag~, mankind bas, for econonUc and other reasons, conswnly Înterfered.

witb nature. In the past,

mis

was ohen done wirhout consideration of the effects upon the enVÏIonment. Owing la new- scienrific insiglus and tO a growing awareness of the risks for mankind---for present and funue generarions-of punmit of such interventions at an unconsidered and unabatcd pace, new norms and sWldards have becn devdoped, set

Forth in a great number of instruments during the l2.n two decades. Such new norms have

(0 be taken into oonsidera.tion~ and such new srandards given propcr wcighe, noc only when Stares oonremplaœ new activities but also when oontinuing with aceivitics bcgun in the past.'

The risks posed by new rechnologies have causcd a paradigrn shift: in the inter- nationallegal order. Indeed. these risks require a now mode ofboth rhinking and of action [Q prevent their realizarion and meir potendally ÎrrevefSible conse- quences. Traditional international law is

fàmiliar

with the issue of risk (risk ta

international peaœ and 'securil)'. risks in International Humanitarian Law, risk ta

human tights. etc) and has long since developed means of risk avoidance and prevention. However, this perception of risk as defincd by the Internarional Coun of Jusrice is moscly bascd on a reacrive approach. Thar is, it is dependent on the cenainty of the imminent occurrence of the risks. For instance. effons to

prevent a wear ro peace and securiry ofren occur when c1ear evidence of the threat is esrablished. including the beginning of hostiliries or the movement of rroops.

The management of risks deriving from new technologies. however, requires a new approaeh bascd on uncertainty and foture rorots. New legal rools, mechan- isrns, ru/es, and principles are thus needcd ta face the specifie challenges posed br those risks. These innovative legal concepts go beyond the simple prevention or

3 Y. Lambert·Faivrt:. DroiJ dM Jqmm4g~ ctn'fJIJUJ ~ dîndnn"isatUm (3ème édifion, 2000), at 614.

" Laghmani, 'u droit international face aux nouvelles technologi~: C2ppon incroducdf', in

R Ben Achour and S. Ughmani (eds),

u

droit ;ntemJztion4 faa aux nourxlks techno/qgUs (2002) 23 If.

S Gobcikovo-Nogymaw, Proj= (Hunga')'/Slovaki2) (1997). ICI Reporu (1997), at p'" 140.

NroJ TeclJ1Wlngm. th< fucautionary Principk. and Public Participation 163

reduction of present and weO-knoum risks foreseen in traditional intemationallaw to encompass a OeY{ rationaJe, ie

mat

of precaution.

The present contribution will focus, fust, on dte definition of dte notion of precaution and its constitutive elements. and will analyse the manner in which dte precautionary approach brings new coneerns and new paradigms into dte internationallegal order. Precaution's interwoven links widt public panicipation will dten be developed in Pan 2, particularly as dtey involve dte norions of risk assessme.nt. risk management, and risk communication. The chaprer will con- c1ude in Parr 3 widt remarks on dte socieral dimension of precaurion.

1.

Risks

and International

Law:

The Virtues of Precaution

Precaution srans from dte prentise dtat dte absence of scienrific certainry should not be used as a prerext to postpone decisions if dtere is a risk of serious or irreversible damage to dte environment or to public healdt. Precaution is a key concept in international sustainable development law and is increasingJy pene- crating dte area of human rights and healdt. A commonly given definition of dte precautionary principle/approach⁶ is dte one contained in the 1992 Rio Declararion on Environment and Development. Ir reads as follows: .

ln order to protect the enVÎIonmcnc, the precautionasy approach shall be widely applied by Statt':S according to dtcir capabilities. Where there are rnrears of serlous or irreversible damage. bdc of full scienrific certainry shall Dot he uscd as a reason for posrponing COS(- effective measures to prevent environmental degradacion.⁷

The Rio Oeclararion on Environment and Development played a pioneering role in dte process of crystallizing dte concept of precaution in international law.

Precaution tends ro deCy standard or dassicallegal assumptions. Ir is in essence a meta-Iegal principle, allowing legal provisions to incorporate considerations beyond dtose resulring /Tom strictly positive law' White dtese characteristics endow dte precautionary ptinciple widt a certain originaliry, they also determine dte complexiry of its analysis.

A. Precaution and International

Law

Law has long becn a reOeerion of Cartesianism and positivism, dominant schools of dtought of modem times. New challenges con/Tonted by humaniry as a whole

6 ln t.his chapler, the femlS 'the precautionary principle',

'me

precautionary approach',

•

and 'precaution' will lx used interch.angably.

7 Principle 15 of the Rio Declaration on Env:ironment and Devdopmem, UN Doc.

NCONF.151126. vol I. ano", I, 1992.

8 J. Carbonnier, Fkxibk Droir (1998), ^al: 66; Desideri, 'La precaution en droit privé' (2000) 15 Recueil le Dalloz 238.

164

and trepidation sparked by technological progress have led ro a questioning of legal Canesianism and of what has been described as 'Euclidian law'! This revolution did not take place directly within the legal system, but teSulted /Tom the remodelling of both philosophical and scientific thought. On the philo- sophicallevel, 'the heuristics of fear', devdoped by Hans Jonas,l. pioneered the process of reflection on Out interaction with the world, with science and with humanity. Major catastrophes (Chemobyl) and unœrtainties (the consequences of climate change) have led ro the definition and assessment of other parameters of scare action in the international sphere. In this sense, precaution is a tooi jockeying tO be included in the new understanding of human relations to the environment in the intemationallega1 order. This order uses precaution as a [001 to <jurirucize' these new concc::rns. International law cannot ignore precaution.

Precaution /aVOutS the emergence of new paradigms that conttibute to the development of a global tisks govemanœ regime. These paradigms are those of uncenainry, interdependence. and anticipation. Precaution chus influences the philosophy of law in its entirety.

1. Precaution and the New Paradigms of International Law (a) Regulating uncertainty

The precautionary apptoach developed fullowing conœrns over the regulation of uncertain ecological phenomena. T raditionally, intemationallaw has been based on the dogmas of Canesian rationality. As a result, only those phenomena character- ized by a certain scientific certainty were addressed by international cegulation.

When the Vienna Convention for the Protection of the Ozone Layer was adopted in 1985, the extent and the nature of the hurnan impact on the ozone layer wece largely shrouded in uncertainty.1I In the same vein, scientific uncer- tainty was widely prevalent in 1992 when ewo of the key multilareral environ- mental agreements were opened for signarure in Rio, narnely the UN Framework Convention on Climate Change and the Convention on Biological Diversity.12

9 Timsit. 'Pour une nouvdJe définition de la nonne' (1988) 36 Recueil le Dalloz 267.

10 H. Jonas, ù principe rerponsabilitl: ^UFU ah~ /X'Ur III civi/isaritm ~hnologique (1993), al 13.

Il See che Preamble of the 1985 Vienna Convention fOr the Protection of the Ozone Layer: 'Aw:ue aIso of the n«xi for funher research and systenw:ic o~rvations ta funher develop scÎendli, know- ledge of che ozone layer and possible adverse effecu resulting from Îts modification.', available at <http://www.unep.orgl02one/pdfilviennaconvenrion2002.pdf'> (Jast accessed Il Dettmber 2007).

12 See the Preamble of the 1992 United Nations Framework Convention on Oimate Change:

'Noting dw there are many unceruinties in predictions of dimate change, panicularly

wim

regard

10 the timing. magnicude and regional panetns mereo[', (1992) 31 lLM. at 851. See also the Preamble of the 1992 Con~ntion on Biological Dive~Îty: 'Aware of the generallack ofinfurmation and knowledge regarding biological diversity and of the urgent neM. ⁽⁰ develop scientific. technical and înstitutional capacities to provide the basic understanding upon which to pbn and implement appropriate measures', (1992) 31 HM, at 822.

New Technologies, the Precautionary Principle, and Public Participation 165 One can also re/èr to the Canagena Protocol on Biosafety which was adopted in 2000 (hereinafi:er the 'Canagena Protocol') at a rime of major scienMe uncer- tainry regarding the risks of genetically modilled organisms for the environment and public health-uncertainry whieh in fact persisted afi:er the Canagena Protocol's entty into force in 2003."

(b) International law and the challenge of interdependcnce

A precautionary approach emphasizes the interconnections and inter-sectoral aspects of the environ mental problems to be regulated. It thus redefines the methods leading to the development of law at twO levds. First, it excludes a companmentalized approach towards regulation, acknowledging the intrinsie and exttinsic linkages arnong the phenomena 10 be controlled or managed.

Lawmakers no longer lintit themselves 10 the known impact of a human activiry or of a fieY{ technology on cenain elements of the environment. Rather,

mey

also

take inta consideration the impact, even if uncenain, on other environmental components. For example, an effective and adequate regulation of the ozone layer cannot ignore desertification, climate change, and atrnospherie pollution. These four elements are inherencly linked. This new kind of complexity therefore calls, as its corollary, for a new and more comprehensive kind of legal approaeh.

Indeed, the very concept of global environmental govemance requires a holistie and systemic treatment of ail its components.

Secondly, a precautionary approach also presumes a flexible and open-ended view of law. T raditionally, international law is based on a sttaight and focused form of legal reasoning that makes it difficult to consider emerging and inter- connected issues. Precaution, on the omer hand, as a technique of managing uncertainty is very different from any notion of a finite law. It is built upon a foundation that alIows adjustrnent and openness. The procedutal technique of developing a frarnework convention that is later complemented by the adoption of additional protocols addressing the progression of scientifie knowledge fàcili- tates this kind of'lega! opennes'. The 1994 Protocol 10 the 1979 Convention on Long-range Transboundaty Air Pollution regarding new/y ;ntroduced reductions of swphur emissions represents a typical example of this phenomenon.¹⁴ That mis new reduction is essentially based on precaution is dear frOID the recms of the Protocol's Preamble, which relevancly stares '[rJesolved 10 take precautionary measures ^CO anticipate, prevent or minimize eroissions of air pollutants and mitigate theic adverse effecrs'.

13 See the Preamble of the 2000 Gutagena Protocol on Biosafety ta the Conventi0ll on Biological Diversity: 'Aware of the rapid expansion of modem biorechnology and the growing public concern avec its potenrial adverse effect'i on biologica1 diven;ity, taking also mco account risks to human health·, (2000) 39 [LM, at 1027.

14 The Protocol panially amends the 1985 Helsinki Protocol on the Reduction of Sulphur Emissions or their Transboundary Fluxes byat least 30%, available at <hnp:J/www.unece.org>

(last accessed Il December 2007).

166 lAurence Boisson de Cht1ZOUT1les (cl An anticipatory approach

By deflnÎrion, precaurionary measures auempr to control events [hat have flot yer occurred and may nevee occur. Precaution focuses on the future and therefore constitutes a technique of legal anticipation with regard to global risks.¹⁵ For instance, the Preamble of the Convention on Biological Diversity carries an explicitly anticipatory message: 'Noting that it i5 vital to anticipate, prevent and maok the causes of signiJicant reduction or loss of biological diversity at source' (empbasis added). Precaution rejecrs a curative legal approach. Given mat it is flot characterized by a curative logi~ precaution differs in many aspeets from the polluter pays principle which is closely linked te compensation for environmental damage. Funhermore, precaution does not depend simply on a cause and effect relationship. Precaution goes beyond the principle of prevention which ries action CO scientific certitude. This need for anticipation is addressed in legal systems through the precautionary principle.

B. Precaution: A Means for law to Address New Conœms

Precaution i5 a tool for introducing new values into the internationallegal system, which essentially lead to new modes of thought (1) and of action (2).

1. The ]uridicization' of a New Mode of Thought: Complexity

The new thought method to which intemationallaw refers when it incorporates a precautionary approach is that of complexity, or, to quote Edgar Morin, chat of 'complex thOught'.16 What constirutes complexity? The idea of a complex and temporary order bas replaoed chat of a determinism clear, simple, universal, and eternal.^l? Considering precaution as 'the law of complexity' highlights twO of its substantive charaeter traits: uncenainty and globality. I8 Unœttainty, because taking into account complexity comes precisely /tom the refusal of a simplistic approach. Precaution is therefore 'the law of uncettainty', hostile to the dogma of Canesian rationallty. International public action is called upon to create a new paradigm: the management of uncertaincy.19

15 Set: Mbengu~, 'Towards a Precautionary International Law: About Unœminty, Intc:rde- pendence and Anticipation in Global Environmemal Governance', 2 IHDP Uptit1k, Newsktter uf ^the

In~ Human Dimmsûms Programnu: on Global EnvinmmmtaJ Chang~ (2004) Olt 13.

16 E. Morin, Introduction d la pmsü compkxr (1990).

17 MiLani. 'La complexité dans l'analyse du S)'5tème-monde: l'~vironnement et les régulations mondiales' (2000) 46 Revue Droit et Société 425, Olt 426.

18 Diebolt, 'La complexité comme paradigme pour concevoir une régulation juridique adéquate' (2000) 46 Revue Droit et Société 485.

l'

On the concept of scientmc uncertainty, see infra-

New T echno/ogUs, th, fucautionary Principk, and Public Participation 167 Being the law of complexity, precaution is also the 'Iaw of globality'.2o Indeed, complexity suesses the traIlsversality and interconnection berween phenomena, especialIy in the environmental field. An eflèctive and efficient management of these phenomena requires a global approach. In rhis contexr, precaution mani- fests irself as a fitring legal technique to manage the interrelation and interaction between various phenomena.

Precaution as a legal technique presents irself as an appropriate and adequate path IOr the administration of common goods and spaœs. The uncerrainty of the potential consequences of a state's actions on the well-being of omer societies requires the elaboration of global strategies for the management of these common spaœs. In the environmental field, in which precaution finds its ptincipal application, the concrete issues at stake in terms of international relations ohen ex:tend beyond the borders of states and regional groupings. Such is the case in relation to climate change, protection of biodiversity, deforestation processes, and use of shared naruta! resources, especially hesh water resources.

2. Th, Juridicization' of a New Mode of Action: Anticipation

In substance, precaution obeys a parricular ratione tempori process. The legal temporality to which precaution refers is the n.rure. In rhis, it is 'the law of anticipation'. The logic of precaution, centered essentially on the uncerrainry of the effccts of human activity, highlights the necessity to take ioto accouot the n.rure and polential effects of rhis activity. Precaution anticipates in that it sedts

to govem situations that have not yel arisen. Therefore it is not a body of law lOcused on the concept of reacrion. Precaution as a legal technique therefore guatantees the right to anticipation in the internationallegal system. The dogmas of objecrivism and realism have often led law in genetal and intemationallaw in particular to ignore a large portion of the legal temporality-the n.mre--taking into account exclusively the past and the present.^2I

As a law of anticipation, precaution is a fortiori a manifestation of <me law of prospective'. Ir even adds a touch of originaIity by raising the dimension of uncenainty lO the starus of a fundamental element of consideration in the elaboration of any public or private prospective policy.

As a resuIt, the stages of thought and action in the precautionary approach are intimatdy linked.. Ind.eed, it is difficult to conceive of anticipation without uncerrainty, and uncertainty without anticipation. Similarly unlikely is the conception of uncerrainty and anticipation without any reference to a global

20 Set: Cameron and Abouchar, The Precautionary Principle: A Fundamental Priqciple of Law and Poliey for the Protection of the Global Environment', (1991) 14 Boston CoDege Incl and Comparative L Rev 1, al 17.

21 Gurvitch, 'La multiplicité des temps sociaux', in G. Gurvitch, La voclltion actue/k tk la sociologie, vol Il, (I963) 325. According (0 this author, 'la vie sociak s'irouk d4zns des temps multiples, tovjours divergmts, J()U.vmt contradictoires et dont l'unification rtlativt, Iii~ à UIIL hiérarchisation souvenr pricairt, rqnismte un problbm pour toute soditi. '

168 lAurmce Boisson de ChILWU77U1

approach. The uncerraincy of the spatial extent of the analysed phenomena requires global anticipation-thar is, not ignoring the potenrial implications of a phenomenon in omer spaœs, or IDose of one system on others. Precaution caUs for the re-examination of the notion of sparial sovereigncy as skerched by ttaditional international law, and puts empbasis on a need for a special ',erri- torialization' in a global contex[.

Precaution is not a volatile notion in inœmationallaw. On the conuary. inter- nationallaw, in order to guarantee legal secwicy and predietabilicy, seeks tO identifY criteria permitting the durable establishment of the legal content of precaution.

C. The Notion of Precaution: IdentiJYing the Criteria

of Definition

Precaution bas fOur fundamental criteria, which deline it as weU as justifY ratUme materiae its application in given situations. These criteria endow il wirh a par- rieulat srructlue, an original basis compated

'0

other principles or apptOaches of intemationallaw. Three of these criteria (risk, damage, and scientifie uncertaincy) justilY the application of precaution a priori, whereas the las, eritmon (capacities) intervenes a posteriori ^to objeetively de,ermine its applicabilicy, permitting the passage /Tom 'application' [Q 'applicabüicy', /Tom 'desitabilicy' tO 'feasibilicy'.

1. The 'Risk' Criterion

(a) Meaning and content of the risk criterion

Risk is the very essence of precaution. Precaution' s raison dme originates in law' s aspiration ta assess and manage risk in our socieues. Risk is a more or less foreseeable and contingent danger that can cause damage.

Tt

is therefOre arbitraty in its essence. Volatility is its nature; ilS occurrence can be unforeseen. even unexpecred. As long as there is any trace of doubt as to the occurrence of an event, there is risk. ²² In an .ttemp' to Iegally and precisely qualilY the risks targeted by precaution, it is useful ta recaU the cypology of risks compüed by Nicolas de Sadeleer, who was inspired by lessons drawn /Tom German thought²³ According ro him, there are wee main categories of risks:

• 'Unacceptable' or 'definite' risks, for whieh the causal Iink between the event and

me

^{damage is} scientificalJy proven, even if doubt remains as [0 che

22 &e Martin. 'Le concept de risque et la protection de l'environnement: évolution parallèle ou fertilisation croisee t, in M. Prieur and C. Lambrechts (eds), Us Hommes d l'mvironnnnart, ro hommage il Alatlndre Km. Paris. Frison~Roche (1998) 451. See also Kiss. 'Droit et risque', in (1991) 36 Archives de Philosophie du Droic 49.

23 N. de Sadel«r, La principn dt. poliun4r-JNlYt!Ur. de prlvmtion et de précaution (Essai $Ur la genèse et la portie ~rit:ii.que de rpg/ques principes du droit de l'environnement) (1999), at 175 ff. See a1so N. de Sadeleer, Environment41 Principks: Fn»n Po/itiœl Slogans to Legal Rules (2002), al 91-226.

New Technologm, th, fucautionary Principle, and Public Participation 169 time it will take for the damage to occur. Th"", risks should be eliminated by the principle of prevention .

• 'Residual' risks, those inherent to normal human activity that must be

tolerated (eg the risk implicit in dtiving a car or taking a plane). Th"", risks, which 'rest on purely speculative considerations without any scientific foundation', do not need ro he taken into account in the decision~making

process.²⁴ In order to avoid situations wh.ich would be absurd for human activity, residual risks have to be exduded from the precautionaty principle's range of application .

• 'Uncenain' risks, whose existence has not been established by science, but

cannot be disntissed. These must be addressed by the precautionaty principle.

The legal tenninology used in inœrnational instruments in relation to cisks varies. In sorne instruments, referenœs are made to 'threar'; elsewhere, however.

references are made ro che idea of 'potential' nuisance or danger.

(b) The components of a precautioOaty risk a.ssessment

The main difliculty with the risk criterion lies in its assessment. Challenges such as quantifying the probability of occurrence of risk and qualilYing the risk itsdf arise. ]ntcmational law does Dot provide definite answers, but international practice provides indications of what is, in objective terms, the evaluation of risk 25 The Canagena Protocol for instance, provides fur a risk assessment pro- cedure in its Annex III. The objective of risk assessment under the Cartagena

Protocol 'is to identuy and evaluate the potential adverse effeccs of living modified organisms on the conservation and sustainable use of biological diversity in the likdy potential receiving environment, taking alsa into account risks to human health.' The Cartagena Protocol was a pioneer in formulating principles of risk assessment as weU as integrating precaution into the assessment of risks posed by new technologies such as biotcchnology:

3. Risk assessmeot should be carried out in a scientificalty sound and transparent manner and cart take ioto account expert advice of, and guKlelines developed. by, relevant imemarional organizations.

4. Lack of scienrific knowledge or scienrific consensus should not neœssarily he inter- preted as indicating a panicular level of risk, an absence of risk, or an acceptable risk.

,. N. de Sadd"", Environ"",,"" Prindp/e" From Po/itical Siogam to Legal R.Ja (2002), ar 158.

25 & an example. ir is interesting (0 poinr OUI mar the wro Appdhte Body in the ^CLSt EC - Mtaturrs Conceming Mat and Matt Prucûu:ts (Honnones) noce<! mat the risk mmti~od in An 5, pua 1 of the SPS Agreemem was nO( only a 'risk asa:ruituhle in a SCtencc laborarory', bUt a1so a 'risk in human societies as mey actually exist, in ocher words, me.acrual potential for 2d.vecsc dfo:ts on hwnan hea.lth in the real world where people live and work and die', Stt itifta. The AppeUate Body chus affirmed that the scientilic evi.dence which the European Communities referrcd to did nor concern the type of hormone Olt stake; for this te2SOn risk assessment was deemed insufficient. See the Report of the Appdlate Body, paras 187 and 199-200, available ar <http://www.wro.org> . .

170 Laurmce Boisson tU Chazourne1

5. Risks associated with living modified organisms or prodUCIS theroof, namely, pro-

""""d marerials mat are of living modified organism origin, containing derectable novd combinations of replicable genetic material obraïned through the use of modern biorechnology, should be considesed in the contex( of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.

6. Risk assessment should he carried out on a case-by-case basis. The required infor- mation may vary in nature and levd of detail from case to case, depending on the living modified organism concemed, irs inrended use and the likely potenrial receiving environment.²⁶

The Cartagena Protocol goes funher by identifYing a methodology for the risk assessment of risks deriving from modem biotecbnology. Annex III of the Protocol emphasizes the importance of precaution by making dear that 'The process of risk assessment may on the one hand give tise to a need for funher information about specifie subjects, whicb may be identified and requested during the assessment process, while on the other hand information on omer subjects may not he relevant in sorne instances.' Risk assessment is based on the following steps:

1) An itkntification of any nove! genotypie and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological ruversity in the like!y potential receiving environment, taking a1s0 into account risks ta hurnan health.

2) An roa/uation of the /ikelihood of these adverse efficts being realized, taking inta account the leve! and kind of exposure of the likely potential receiving environ ment to the living modified organism.

3) An roa/uation of the consequences should these adverse effects he realized.

4) An e1timation of the ovmlll risk posed by the living modified organism based on the evaluation of the likelibood and consequences of the identified adverse efIècts heing reaIized.

5) A recommendation as ta whether or not the risks ^are acceptabk ^or manage- abk, induding, where necessary, identification of strategies ta manage these risks.

6) Where there is uncertainty regarding the k / of risk, it may be addressed by requesting furrber infurmation on the specifie issues of concem or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment.²⁷ (emphasis added) Ir is imponant to note

mat

mese sœps do not constitute a risk assessment in itself.

They are only 'risk assessment tecbniques' to refer ta the œrminology used in rhe

26 Anno. III of the Cartagena Protocol on Biosafet:y, S14J'ril note 13.

27 Ibid.

New T ecbnologies, the Precautionary Principle, and Public Participation l7l Agreement on Sanitary and Phytosanitary Measures (SPS Agreement),2' The Panel in rhe EC - Biotech case recalled, for insrance, rhe distinction ro be made between a 'risk assessment' pa se and 'risk assessment techniques' raken into account in a process of risk assessment:

Tome aIent the European Communiries is arguing mat there is no requiremem [0 assess 'risks', we disagree. By ilS own tenns, Article 5.1 requires [WfO] Members [0 base their SPS measures on an appropriare assessmem 'of the risks ^[0 hurnan, animal or plant lue or health.' The immediate conteXt of Anicle 5.1 conflrms mis view. Article 5 is caprioned 'Asswmmt of Risk and DeteIDÙnation of the Approptiate Leve! of SanitaIy or Phytosaniwy Prorection.' Moreover, Articles 5.2 and 5.3 of the SPS Agrmnent specil»

relevant factors [0 be taken into account by Members 'in the assessment of risks' and 'in assessing the tisk to animal or plant !ife or health.' Finally, Article 5.7 of the SPS Agrummt provid.es rhat in circumsr.ances where relevant sciemmc evidence is insuHÏcienr and a Member bas adopted a provisional SPS measure based on available peuinent information, it must seek [0 obr.ain the addirional information necessary for a more objective assessment of 'risk' ... As the European Communities points out, Article 5.1 provides that Members must base their SPS measures on an appropriaœ assessmem of risks, 'taking inro account risk assessment techniques developed by relevant international organizations.' In our view, the phrase <taking into account risk assessment uchniques tkwlop,d by T<ûvant intematUinal organizatUins' do<s not P4dT<S5 th, issue

of

wheth<r risks aTe to b,

=,d,

but rut/m-how risks aT< to be

==d.

This is ckar ftom the refn-ence to

<techniqJUS~ of risk tlSSfiSmmt. ContraT] to the European Communities, we therefore do not considn that the phrase in question supports the view that no assessmmt of risks is required T 0

the contrary, the phrase in question would, in our view, be unneœssary if there were no requiremenr to assess risks.²⁹ (emphasis adde<!)

The components of a precautionary risk assessment have been specifically ana- lysed in a case brought before rhe Court of First Insrance of rhe European Community, ie rhe Pjiar Animal Health ¹¹ Council of the Europe Union case.^3O Pfizer submirted rhat rhe contested European regulation should be annulled, since the European Community institutions had made errars in the assessment

28 For a comparison of me provisions on risk assessment and precaution in the Cartagena Protocol on Biosafety and che Agreemem on Sanitary and Phytosanitary Measures (SPS Agreement), sec Oliva, 'The Canagt:na Protocol on Biosafety and the .Agreement on Sanitary and Phytosanitary Measures: Wlw will Decisions Regarding GMOs have ta he Based on?' (2002) 13 lot'l Legal Perspectives 22. The SPS Agreement is available at <http://www.wto.org>.See, for instance, An 5.1 of me SPS Agreement: 'Me:mbers shall ensure that meir saniwy or phytosanitary measures are basc:d on an assc:ssme:nt, as appropriate ta the circumstancc:s. of the: rîsks to human, animal or plant life or hc:alth. taking into account risk as.sc:ssment techniques developed by me relevant international organizations.' &e infra the notion of risk analysis under the COtkx A1immtarius ProceduraI Manual.

29 European Communitit'S - M~aJurtJ AJfocting thl Approval and Markmng of B;!;tech Products, Reparu of the Panel, WT/DS2911R. WTIDS292/R. WT/DS293/R, 29 Sep"mber 2006, p=

7.3021-7.3022.

30 Ifizn Animal H~alth v Gouncii of the Europe Union, Judgment of the Coun of Fim Instance.

11 Septe:mber 2002, Case T-13/99, available at <hnp://www.curia.europa.eu> (last accessed 11 Deœmber 2007).

172 LaUTroc< &isson de Chazournn

and management of the risks to human health associated with the use of virginiamycin as a growth promo,er, as weU as in their application of the pre- cautionary principle.

Le, us recaU tha< the Preamble

'0

the conres,ed regulation shows that the European Council, in adopting the measure, took the viewthat the use of virginia<nycin as an additive in feedingstuffs involved a risk to hurnan health and that, accordingly, it was necessary to withdraw the aumorizations to use the product³¹ Beth patties to the dispute admitted that, at the rime of the adoption of the conrested regulation, neither the reality nor the seriousness of the risk had been scientificaUy proven. Ir was agains, that background tha, the Council relied on the precautionary principle as justification fOr adopting the regulation.

Plizer did not dispute tha" in principle, the Community institutions may cake preventive measures if, foUowing a risk assessmem, i, is found tha, the use of an antibiotic, such as virginiamycin, as a growth promoter in animals involves a risk of a transfer of antimicrobial resistance &om animais to humans and, conse- quently, of a reduction in the effectiveness of certain medicinal productS used in human medicine for the treatment of dangerous infections. However, Pfizer maintained that the Communiry institutions did no' correctly assess tha, risk, and argued essentiaUy tha, these institutions had made theu decision for reasons of political expediency without a proper scientific basis. For Plizer:

the Communicy institutions must show

mat

the risk, although it has not actu.ally become a rea1ity, is nevertbeless probable. The existence of a very remote risk should he allowed given the concrete positive ekments arising from the use of the product conœmed. In any event, the Community institutions cannOt legirimaœly apply a tcst which p6zer describes a:s a 'lero risk test. SueR a test is inappropriate 5Înce ic is impossible co sacislY. It amounts essentially CO requiring probatio diabolica from the indus cry, someming wb.ich is reoognized as unlawful in ail the leg:ù systems of the Memher Staccs ... It is nover possible co prove conclusivdy thal a chemical or pharmaceurical compound or anything creaced br modem [echnology represents a zero risk [0 public health now or that it will do 50 in the future. T 0 apply such a test would quickly lead [0 me par.oIysis of [echnological devdopmem: and innovation.³²

The CouncU of the European Union considered for ilS parr tha, the contes,ed regula<ion was adopted on the basis of an adequate assessment of the scientific knowledge available at the rime of its adoption. The CouncU conlirmed that any such measure withdrawing authorization canno' he based on a ,est desctibed as zero risk. However, the bct mat the competent authorities had, at a given rime, considered that a patticular additive meets the conditions fOr au,horization and have therefore authorized it does not imply tha, ,he manufàcturer is &eed from

31 Council R<gulation (Eq No 2821/98 of 17 O=mber 1998 amending, as regard. w;d .. !raw.ol of tht authori:z.ation of œnam aotibiotics, Directive 70/5241EEC conctrning additiVt5 in

f=li"l\'ruffi, • ..noble .r <hnp.l/www.legalrext.eeltcxr/en/T40644.htm> (bst acassed 13 O=mber 2007).

32 Pfize:r Animal H~alth v Council of tIN EurojM Union, supra note 30, para 130.

New Ttc/mo/ogies, th. fucautW1IJ11] Principk, and Public Participation 173

me onus of proving that its product continues to meer such conditions. In the view of the Council:

Scientilic knowledge and the risks to hwnan heah:h associated with we of a particWar prooucr evolve. Consequencly, when fàced with new sdencific evidence mat the use of an additive poses a hazard to public health and that the hazard has =ched alarming proportions sincc the additive was ficst aumorized, the Communiry institutions are fully enritled [0 requite the manufacturtr in question ro demonstrate mat its product conrinues Dot ta represent a risk to human health.³³

The Court of Fi"t Instance, in a very imeresting and detalled dicrum, explained the purpose of a risk assessment in

=

where the precautionary principle hnds application:

lt is appropriatt ro bear in rnind that, as the Coun of Justice and the Coun of Ficst Instance have beJd, wbere mere is scienti.6.c uncertainty as [0 the existence or eneor of risks to human healcb, the Communicy instirutiollS may, by rea50n of the precaucionary principle, take prote<:tive IDeasUles without having to wait unru the realily and seriousness of those risks become fully app<trent ... Ir follows) 6m, mat as a resuJt of the precaudonary principle, as enshrined in Article 130r(2) of me T reaty, the Community institutions were cnritled to wc a preventive measure: regarding the use of virginiamycin as an additive in feedin""ruffi, even though, owing ro cxisting sci<ntific unœnainry, the realiry and the seriousness of che risks to human health associued with mat use were nor yel" fully apparent. A fortiori, the Community institutions were not required, for the purpose of taking preventive action, to wait for the adverse efFeas of the use of the produC( as a growth promoter to marerialize ... TIu!.';) in a situ.uion in which the precautionary principle is applied, wh.ich by ddinition coincides with a situation in which there is seientil1c uncertainty. a risk assessmem cannot be required tO provide the Community institutions with conclusive sdentrnc evidence of the realîcy of the risk and the seriownes.s of the potential adverse effects were thar risk to become a rc:ality ... However, it is also clear From the case-law that a preventive rneasure cannot properly he based on a purely hypothetical approach ro the risk, founded on mere conjecture which has not becn scientifical1y verified'"

And the Court of First Instance wenr on to conclude that

The precautionary principle cm therefore apply only in situations in which there is a risk, notably to human health, which) although it is Dot founded on mere hypomeses that have not been scientificaUy confirmoo, has not yer becn fully demonstrated. ln sum a siruatwn, risk mus constitutes a function of IDe probabiliry m.at use of a product or a procedure will adversely affect the interes" safeguarded by the legal otder. Hazard (danger) is, in rhis context, commonly used in a broader sense and describes any product or procedure capable ofhaving an adverse effecr on human health (see in

mat

regard, at an international level) the provisional communication from the Codex Alimentarius CommÏlSion of [he Food and Agriculture Organization of the United Nations and the World Health

" Ibid, pan 134.

34 Ibid, p .... 139-43.

174 Laurence Boisson de Chazournes

Organization,

ex

2/20, CL 1996/21-GEN, lune 1996). Consequently, in a case such as this, the purpose of a risk assessment is to assess the degree of probability of a cenain product or procedure having adverse effecrs on human health and the seriousness of any such adverse effecrs.³⁵

2. The 'Damage' Critcrion

Once the decision-maker has an idea of the likelihood of occurrence of the suspected risk, he will naruraIly reflect on the possibilities of shidding himsdf from it. Must this tisk be reduced or even eliminated regardless of the importance or severity of damage it could provoke? Or on the COllrrary, is intervention required only if what is at srake is worrh the eflOrr? His attitude is obviously subject to variations accorrling to the probabiliry of occurrence and especially ro the importance of damage.

The terminology used to denote damage in international instnunents varies.

Reference can be made rlirectly to the concept of damage.³⁶ Sorne instruments refee to the concept of <impact'. ³⁷ In spite of these terminological variations, the formulation of precaution in international instruments embodies an original, if not special, concept of damage. The larrer is usually bound ro a threshold of severiry, which Iimits the applicarion of the precautionary principle. This threshold usually invokes concepts sucb as 'severiry' and 'irreversibiliry'. The 'damage' criterion is an important element of the definition of precaution, even thougb it is inrrinsically linked to the risk criterion.

3. The 'Scier/tifle Uncertainty' Critcrion (a) Content and meaning of the criterion

Whenever precaution is formulated in an international instrument, the criterion of scientific uncenainty is bound to it. The clement of uncertainty is a sine qua non conrlirion to the application and even to the legitimacy of the precaurionary principle.³⁸ Indeed, the larrer r1iffers from the principle of prevention precisely in its reference to the aIOrementioned clement. The 'preventive model' is forced to depend constantly on science and its expertise, the only way to allow for a certain

35 Ibid, l'ms 146-8.

36 Stt Principle 15 of the Rio Decbration on Environment and Developmem: 'Where there are threats of serious or irreversible damage.' The Rio Declaration is also available at <http://www.

unep.org>. Set: also the United Nations Framewurk Convention on Climare Change: 'Where there are threats of serious Ot irrevenible damage. lack of full scientific œnainty should DO( he used as a reason for postponing sucb measures' (available at <hnp:l!www.unfcccoint».

37 Set: the Convention on the Protection and Use of Transboundary Wareocourses and Inter- national La1res: The precamionary principle, br vinue of which action ru avoîd the potential transboundary impact of the release of hazardous substances shall not he postponed' (available at

<h~:llwww.unece.org> ).

38 R.emond-Gouilloud, 'Le risque de l'incenain: la tesponsabilité face aux avancées de la science', in (1993) X(4) La Vie des Sciences 341, ^al 355.

Nnv Technologia, the fucautionary Principk, aruJ Public Participation 175 objoctivization of the risks taken. Yet if prevention's strength is found in its reference to scientific knowledge • .rus .Iso reveals its limitations. If risk is known.

preventive measures c.an be caken in full knowledge of the situation. Prevention is only possible for known phenomena. It is difficult·to prevent what is unfiuniliar.

and even more difficult tO do 50 with the unknown."

To denote scientific uncertainty, international instruments cefee to 'the absence of complete scientific cettainty· .... 'the absence of absolute scienti6c cettainty·." or even 'uncerrain. unreliable. or inadequate data· and 'the Iack of adequate scientific data'.42 However, a precautionary measure must he anchored co a minimwn level of knowledge, a basis of scientific data presenting a cerrain cons.istency."

(b) Scienti6c nncertainty versus predictability in risk anaIysis:

the case of the

wro

Risk and. more espedally, uncenain risk constiture an important foundation of precaution. The application of precautionary rneasutes needs to be applied to the whole procedure of risk analysis. which is based on the cumulative com- bination of risk assessment. risk management, and cisk communication. Pre- caution can be implemented through these three distinct but ofien overlapping and interacting phases. However. in areas such as international trade law, the precautionary implementation of these concepts may be confronted by the issue of predictability.

Multilateral environmental agreements (MEAs) with potential trade implica- tions such as the Cartagena Protocol on Biosafety or the Stockhobn Convention on Persistent Organic Pollutants (POPs) .... enunciate rights and obligations dealing with trade. These agreements imply

,u

jure and

,u

facto that a party to

thes. MEAs wbo is aIso a

wro

member m.y be in • situation whereby it has to

impose irnpon restrictions regarding productS which pose a scientifically unœrtaÎn risk fur the cnvironment and for public health. Tbere might thus be a conflict between precautionaty policies and measures and rules of the global trade regirne. and especially of the

wro.

39 Rebbinder, ~ Precautionary Principle in an lnrcmational Perspective', in Mi/jormms

Gnmds~ (1994) 95.

40 S«: the Declaration on Sustainable Devdopment of the United Natiom Economie Com- mission foc Europe. Bergen. 16 May 1990, available ^al. <hnp:l/www.unece.orglleginstr/cover.

htm>.

"1

Sec: the Convention for the Prolection of the Marine Environmcnt and the Coastal Region of

the Mcd.iterranean. available aI <http://www.unep.chJregionalsas>; .see a1so the Rio Dodararion on Environment and Devdopment, available at <hnp://www.unep.org>.

42 Sec the Convention on che Conservation and Management of S~ Fish Srocks and Hlghly M;gn'O<)' F;,h S,ocks. a..a.bk at <hnpJ/www.un.cxgfDep'-"1œ>.

4:3 See for instana: the Convention for the: Pror:eaion of the Mariru: Envirorunent of the Nonh- East Adantic, available at <http://ec.europa.euJworldlagrttments>. according to which the prccautionary principle should he applied wh~ merc are 'rc:asonahle grounds for conccm that subscances or energy introduced inm the marine environrncm' may cause hazards.

44 Stockholm Convention on Pemstent Organic PoUUWllS (POPs) (2001) 40 [LM 532.