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Biosafety-An Environmental Impact Assessment Tool-And the Role of the Convention on Biological Diversity

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Biosafety-An Environmental Impact Assessment Tool-And the Role of the Convention on Biological Diversity Chapter 6.5 Biosafety-An Environmental Impact Assessment Tool-And the Role of the Convention on Biological Diversity Anatole F. Krattiger €t William H. Lesser Cortsriltnnt/5t'nior ProgranutteAdt iser & V isiting PrLtJtssor Ir t t t' r rto t i otral Ac ntlt nt q of tI *' Ent,i rotn rcn t 72.77 Con cl rcs. C ut t't,a,Sioi Izer I and. Abstract This paper provrdes a description of biosafety, revien's current biosafety regulations and implementation issues,discusses particular needs and priorities in developing countries pertinerrtto the clevelopmentand implenrentationof biosafety regulatory mechanisms,and ideniifies poterrtialroles of the Corrverrtionon BiologicalDiversity in furthering the adoption and applicationof appropriatc'biosafetv regulations world-wide. "Biosafetv" is a term to de.scribepolicies and procedures to ensure the envirr-rnmentally safe applicatiorrof moderrr bit>technololiv,and can be regarded as an environmental impact assessment(EIA) tool. It is argued that geuetically modified organisms have three types of environmental impact: direct (biological,ecological and evolutionary impacts,or "biosafety" Tterst\; indirect (consequencesof the deployment of a new technology); and secondary (sociologicalancl socio-economic).Nothing conceptual needs to be added to biosafetv regulationsregarding biodiversity protection,it is argr-red,and care must be taken to separate direct biosafetv issuesfrom irrdirect ones, and particularly from socio-economicconcerns. Effective analvsis of the latter two categoriescan only be systematically made following initial field trials. Lrrtial empli.lsrsshould be placedon rrationalcapacity building for the implementation of biosafet'r'regulations, r'vithout prejudice to anv subsequent international protocol. The biosafetvaspects related to "transfer,harrdlirrg and use" (Article 19.3of the Conver-rtion)are three separateisslrt's, and care nlLlstbe takerrto approach them irr a scientificallysound and practicall1' ef f ectiyt- m alllllel'. 1. Introduction The Conr.'entior.ron BiologicalDiversitv (hereafterthe Convention) text is quite clearly dominated bt' issuesof conservatiouarrd sustainableuse of biodiversity. Lessobvious is the atterrtiorrdirecteci irr Article 16 to biotechnology. There, biotechnology, among other technologies,is seen as serving trvo roles: .rs a support tcrconservation, and as a means of WidertingPersptclit,t's on BioJirüsity sustainablyusing geneticresources. Irr either instance,the potential existsfor the importation into, or developmerrt u'ithirr, a country of a non-indigenous living organisms, including organisms with geneticmaterial from other species.Improperly controlled, such organisms have a potential for environmental damage by competing rvith indigenous life forms, hybridising n'ith them, or corrsumirrgor infecting them. Such a loss of speciesand habitat diversity potentially has most severeconsequences in the biodiversitv-rich regions,including centresof origin, lvhich are a particular focusof the Conventiorr. Besides these implied relationships among biosafety, technology transfer and biodiversity, trvcrspecific articles irr the Corrvention address biosafety specifically: Article 8(g) statesthat Partiesto the Corl'errtion should establishbiosafety regulatorv procedures, and Article 19.3requests the Partiesto considerthe need for, and modalities of, a protocol in the field of the safe transfer,handling and use of genetically modified organisms (CMOs). Note that other articlesof the Corrventionmay also be irrterpretedas relevant to biosafety, namely Articles 6(b),7(c), B(h), 14.1(a),14.1(c), 11.1(d), 17.1 and 18.3.Potential specific interpretationsof thesearticles have been dealt with elservhere(UNEP, 1993a;IUCN, 1993) and are rrot further discussedhere. Procedures for determining the environmental safety of CMOs, including their safe handling in transit, are knou'n commoulv as biosafetv. This is all a lengthy approach to saying that the Conveution is inherentlv irrvolved in biosafety as an important aspect of environmental impact assessment.One of the tasks placed before the Intergovernmental Committee on the Convention,n'hich met in Cenevaon 11-15October 1993,was determining how that requirement could be addressed,and in particular what framen'ork the response should take-whether mandated universally as a protocol or as a recommendation in one form or another (UNEP, 1993b). Currently, most industrialised countries have biosafety regulations in place, and these include most, but not all, nations of the Organisatiorr for Economic Co-operation and Development (OECD; for an overvielv see Maloney, 1994).The overwhelming majority of developing countries,horvever, do rrot have regulatory or monitoring procedures in place, mainly becauseof a lack of financialsupport and enforcementsvstems, and often inadequate institutional capacitv.Notable exceptionsare Irrdia,Mexico arrd the Philippines, which have establishedregulations arrd incorporated them in natiorrallaws. Others, such as Argentina and Cuba, have regulationsin place which are not incorporatedinto laws but establishedby ministerial decrees.Finally, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Cuba, Indonesia,Malavsia, Thailand, and Zimbabwe eitherhave ad ftoccommittees, or are in a more or lessadvanced stageof draftirrg regulations.But, due to the above-mentionedconstraints, the processis generallyslorv, and hencethere is substantiallymore to be done in this regard. Itt any case,these nd ftoccomnrittees are gerrerallyset up to review field trial applicationsfor trarrsgenicplarrts-an importarlt function corrsideringthat in Latin America and the Caribbean alorre 32 field trials have been conducted since December 7992.In developing courrtriesirr general,the number has exceedecl65 field trials. Irr industrialisedcountries, well over 1000field trials have beencondr.rcted. Noter.r'orthvis that all of thesead loc committeesin deveLrping countries only work on plarrt biosafett', and essentraliyrlrthirrg has been dorre so far about micro-organisms and other species.It is onlv a matter of time, however, before micro-organismsare tested in the field. The Cerrtro Irrternacionalde Agricultura Tropical (CIAT) in Colombia, one of the Celrtres of the CorrsultativeGroup orr interrrational Agricultural Research(CGIAR), has alreadv submitted a field trial application for Rltizobirrnrto the Colombian authorities. Colombia is currently drafting a biodiversity law that also containsa sectionon biosafety. 354 A.F. Krattiger€+ W.H. Lesser Several non-governmental organisations(NGOs) and bilateral and multilateral agencies are currentlv providing assrstancein developing appropriate regulationsand technical expertrsefor implementirrg biosafetyrules. Most of theseagencies have particular sectoralor resir-nalfoci and irlclude: o the Australian Centre for IrrternationalAgricultural Research(ACIAR); . the Arrimal ancl Health IrrspectionService (APHIS) of the Departmentof Agriculture (L'SDA) oi the LISA; o tl.reBiotec[11plogy Advisory Commissiorr(BAC) oi the Stockholm ErrvironmentInstitute (SEI); . the Footl and Agriculture c)rganizatiouof the unitecl Nations (FAO); . the Inter-Anrericaulnstitr.rte for Co-oPeratiorrorr Agriculture (llCA); . the Intermecljate BiotechrrologyService (lBS) of the InternatiorralService for National Agricultr-rralResearch (ISNAR); . the InternatiorralService for the Acquisition of Agri-BiotechApplications (ISAAA); o tl-reRockefeller Fourdatiorr; . the Urrited Nations IrrdustrialDevelopment Organisation (UNIDO), more sPecificallythe International Centre for Geuetic Engineering and Biotechnology(ICCEB); . the United StatesAgencv for InternationalDevelopment (USAID); . Michigan StateUrriversitr'; and . the World Health Organisation(WHO). The objectiyeof this paper is to evaluate the role of the Convention in the perspectiveof these orrgoing activities. This is clonen,hile recognising that, despite the critical importance of biosafety, it effects biodiversity conserr,atiorronly irrrlirectly.The causality is through the enhanced flow of biotechnology applications, and the implications they may have on the environment in general and biodiversity specificalli'' Hence' Convention resourcesdirected to biosafetyregulations should reflectthis relativeimportance' 2. Environmental Impact of Genetically Modified Organisms 2.L Biosafety and Envirpnmental IrnpactAssessment Environmental impact assessment(EIA) rvas first adopted in the USA in the early 1970s. when it becamecLear that certailtprojects were having an undesirableand unforeseenimPact ou the environmerrt. Several thousand EIA studies ha"'e since beerrcarried out, and most couutriesnow have some form of EIA regulation,as do many multilateralagencies (e.g. ADB, 1gg8;oECD, 1991;world Bank, 1991).EIA is defirredas "a processdesigned to ensure that potetttially sigtrificant environmental impacts are satisfactorily assessedand taken intcr account in the planning, design, authorisatiou and implementation of all relevant types of actir'1]" (Lee, 1989). Thus the process irrvolvesan arralysisof existing environmental conditions arrd arr assessmelltof the significalltimpacts of the proposedaction upon them. "Biosafety" is a term that has been defined as "the policies arrd procedures adopted ttr erlsLrrethe environmentallv sirfeapplication of modern biotechnology" (Persle.vet aI.,1992). Also, as the name implies, biosafetirconcerns the safety of biological material in the environment, alrd hence biosafety regulatiorrs are focused on the direct biological consequencesof
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