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Electronic Journal of Biotechnology ISSN: 0717-3458 Vol.7 No.1, Issue of April 15, 2004 2004 by Pontificia Universidad Catlica de Valparaso -- Chile Received September 15, 2003 / Accepted April 2, 2004

This paper is available on line at http://www.ejbiotechnology.info/content/vol7/issue1/full/6

RESEARCH ARTICLE

The multinational biosafety project of the Organization of American States

Javier VerasteguiCanadian Focal Point

Calle del Comercio 197, San Borja

Lima 41, Per

Tel: 511 225 1150, ext. 143Fax: 511 224 0920

E-mail: [email protected]

Vctor MartnezCamBioTec-Chile

Independencia 1027

Santiago 7, Chile

P.O. Box: 70086Tel: 56 2 6786061

Fax: 56 2 7356373


Willy RocaPeruvian Focal Point

Av. La Molina s/n - La Molina

Lima, Per

Tel: 511 349-5647 / 349-5669E-mail: [email protected]

Myriam de PeaColombian Focal Point

Transversal 9A bis no. 132-28

Santaf de Bogot D.C., Colombia

P.O. Box: 051580

Tel: 57 1 2169800, ext. 2257


Lionel Gil*CamBioTec-Chile

Independencia 1027Santiago 7, ChileP.O. Box: 70086

Tel: 562 6786068

Fax: 562 7356373


Financial support: Grant from the Organization of American States.

Keywords: Biosafety Protocol, Caribbean, Latin America, needs, regulations.

The Organization of American States is supporting the

project Biosafety Regulations in Latin America and

The Caribbean within the framework of the

International Biosafety Protocol. The general objective

is to strengthen national skills for the assessment andmanagement of risks of biotechnology food products,

and to build up public awareness about their benefits

and risks in the participant countries, with the ultimate

goal to promote their safe and sustainable use within a

protective and trusting environment for the public. The

first phase has been focused on the evaluation of the

political and regulatory systems in Chile, Peru and

Colombia, identification of needs, and development of a

*Corresponding author

series of biosafety seminar-workshops in the three

countries, with the participation of distinguished foreign

experts. The second phase, which started in March

2003, has been extended to six countries of Central

America and The Caribbean. The project is helping toidentify the weaknesses and needs for the establishment

of the biosafety protocol in each participating country.

It has also establish the specific training needs and is

given the bases for the design of general outlines of

biosafety training plans, which will contribute to an

efficient implementation of the International Biosafety

Protocol. The project it is also allowing to coordinate

actions between the countries for a better

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implementation of the protocol at a regional level. On

the other hand, the project has allowed to assemble,

around discussion tables, international experts with the

main representatives of regulatory and academic

institutions, business enterprises and NGOs, as well as

with congressmen in scientific and technological matters

and the protection of biodiversity. Thus, the project has

permitted the establishment of cooperation linkages and

has contributed to reinforce the notion of theimportance of biosafety for national development and

the preservation of local biodiversity.

The capacity of countries to carry out risk assessmentsbased on scientific knowledge, is a key factor to determinewhether the new living modified organisms (LMOs) andthe products derived from them will be harmless to both theconsumer and the environment, without imposing unfairlimitations on international trade. In the face of thischallenge, the United Nations Convention on BiologicalDiversity held long negotiations ending up on January 29,2000, when the Conference of the Parties held in Montreal

adopted the Cartagena International Biosafety Protocolwhich regulates the transborder movement of LMOs andderived products so as to preserve the environment and

biodiversity.

By the end of July, 2001, 105 states had signed theCartagena Protocol, including Canada and 18 LatinAmerican and Caribbean countries (among them Chile,Colombia, and Peru); and 51 countries had ratified theProtocol. Therefore, the Cartagena Protocol entered intoforce on September 11, 2003. According to Article 22 ofthe Protocol, cooperation mechanisms will be implementedto develop and strengthen the human resources and theinstitutional competences in biosafety, including

biotechnology in less developed countries, with thefinancial support of the Global Environmental Facility(GEF). The emphasis on capacity building will includescientific and technical training in the adequate and safemanagement of biotechnology, in the practice of biosafetyrisk assessment and management, and in the improvementof technological and institutional biosafety skills. On this

purpose, some organizations in Latin America have beenadvancing capacity strengthening activities in biosafety, asan additional support to national GEF projects which wereonly initiated in the year 2002.

Since 1995, and thanks to the financial support from the

International Development Research Centre-IDRC and thesponsorship of other international institutions, theCamBioTec Initiative has been working on the issue ofstrengthening capacities in biosafety and public awarenessin the Latin American region, having organized severalseminars and courses on biosafety in Argentina, Chile,Colombia, Cuba and Mexico. CamBioTec experience onthis issue, up to 1999, has been summarized in a journalarticle (Verastegui, 1999).

During years 1998 and 1999 CamBioTec designed andimplemented a biosafety and public awareness project inArgentina and Chile, based on the transfer of Canadianexperience. It aimed at reinforcing skills for the assessmentand management of risks derived from LMO products at theArgentinean and Chilean biosafety regulatory agencies.This tri-national project was financially supported by theCanadian International Development Agency (CIDA), and

included a number of activities, such as: 10 internships ofChilean and Argentinean experts in Canada; a comparativestudy on the biosafety regulatory systems in the threecountries (Flint et al. 2000); six courses on risk assessmentand management; four seminars on biosafety and publicawareness; wide dissemination of a Canadian book toenhance public education (Grace, 1998); and the publishingof two books containing the lectures presented during thetwo seminars held in Argentina (Dellacha and Verastegui,2000), and the two seminars held in Chile (Gil andIrarrazabal, 2001). The final completion report describes indetail all activities performed under the scope of this CIDA-sponsored project (Verastegui, 2000).

In other countries of the Andean Subregion, rich inbiodiversity, there is also great interest in participating intraining projects for reinforcing their capacities toimplement the clauses of the Cartagena Protocol. TheProtocol urges the Andean countries to examine theircurrent situations related to biosafety regulation policies,and to identify future needs in their regulatory systems,institutional infrastructure and human resources. Thus,

based on its previous experiences, in March 2001CamBioTec organized, coordination meetings with thehigher authorities of CONICYT (Chile), CONCYTEC(Peru), and COLCIENCIAS (Colombia). The result of thesecoordination meetings was the agreement to design amultinational project proposal which would include thealready mentioned issues, with the purpose to submit it tothe Inter- American Agency for Cooperation andDevelopment (IACD) of the Organization of AmericanStates (OAS).

Thus, the proposal Biosafety Regulations in Latin Americaand the Caribbean within the framework of theInternational Biosafety Protocol was submitted andapproved by the OAS in January 2002 with a donation ofUS$ 57,000 for the first year and US$ 25,000 for thesecond year. The first phase was carried out between Apriland December 2002, under the general coordination of Dr.

Lionel Gil, CamBioTec Coordinator in Chile, and theadvisory assistance of the CamBioTec ExecutiveSecretariat. This first phase was focused on the evaluationof the political and regulatory systems in Chile, Peru andColombia, identification of needs, and development of aseries of biosafety seminar-workshops in the threecountries, with the participation of distinguished foreignexperts. The second phase, which started in March 2003,has extended the scope of the project in order to include six

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other countries from Central America and the Caribbean.

The first phase of the project has contributed to identify theweaknesses and needs for the establishment of theBiosafety Protocol in each participating country. It has alsoallowed to coordinate actions between the countries for a

better implementation of the protocol at a regional level.The results will be shared with other countries of the

Region, thus contributing to the development of otherprojects from both the public and private sectors.

In Brazil [i], initiatives of the Brazilian BiosafetyAssociation-ANBio, a scientific society, established in1999 have been implemented with the support of Brazilianfunding agencies. During the period 1999-2003 around1.500 people have been trained on risk assessment and riskmanagement of GMOs. Also on the field of publicawareness, ANBio has launched its programme of Scienceto the Society which aims to inform the general societyand policy makers about the new developments of

biotechnology in order to reduce fear.

OBJECTIVES

The general objective of this project is to strengthennational skills for the assessment and management of risksof biotechnology food products, and to build up publicawareness about the benefits provided by these foods inChile, Colombia and Peru, with the ultimate goal to

promote their safe and sustainable use within a protectiveand trusting environment for the public. Furthermore,efforts are being made to create a basis on which LatinAmerican regulations will conform to internationalagreements, already signed or under negotiation, that will

push the need to reform national regulations. These

objectives will be achieved by means of promoting theexchange and transfer of technical knowledge andinternational experiences.

Among the specific objectives of the OAS-funded project,the following can be stressed:

1. To evaluate the legal and institutionalinfrastructure existing in Chile, Colombia, Peru,Panama, El Salvador, Costa Rica, Jamaica,Grenade and Trinidad and Tobago in compliancewith the International Biosafety Protocol.

2. To establish the training needs of the differentsocial actors with the purpose of ensuring theirproper qualifications for enforcing theInternational Biosafety Protocol of Cartagena.

3. To organize biosafety seminar-workshops inChile, Peru and Colombia for the purpose ofmaking the institutions in charge of theimplementation of the biosafety regulations and ofthe Cartagena Protocol become consciously aware

of the existing problems and of the need fortraining of their personnel.

4. To elaborate the general outlines for nationaltraining programs in biosafety specific for Chile,Peru and Colombia, taking into consideration thetraining opportunities existing in Canada and Latin

America.

PARTICIPATING ORGANIZATIONS

Chile

Participants institutions from the public sector wereCamBioTec, CONICYT, SAG, INIA, CONAMA and FIA,which collaborated in organizational, logistic and co-financing activities. The parliamentary sector, represented

by the Senate Commissions for Agriculture and theEnvironment, actively participated in the organization of an

International Seminar held in Santiago. The private sectorparticipated through ANPROS in organizational activities.Furthermore, the United States Embassy collaborated in theco-financing of the international seminar.

Colombia

Participants from the public sector were, COLCIENCIAS,and the Colombian Agriculture and Livestock Institute(ICA), which collaborated in activities related to projectdevelopment, as well as logistic organizational and co-financing aspects. Collaboration from the private sectorcame from TECNOS Foundation, the focal point ofCamBioTec. Also FAO, the IICA, AgroBio, the AndeanDevelopment Corporation (CAF) and the Andres BelloAgreement provided financial support for carrying out theseminar which took place in Cartagena de Indias.

Peru

Participants from the public sector were CamBioTec,CONCYTEC, SENASA and INIA, (organizational, logisticand co-financing activities). The private sector collaboratedthrough ADEX and several enterprises. Furthermore, theInternational Potato Center CIP collaborated a lot, both innational coordination and technical assistance.

METHODOLOGY, ACTIVITIES AND RESULTS

The project has been designed in such a way as to promoteboth North-South and South-South cooperation. Startingfrom the characterization of the national regulatorysystems, the identification of training supply and demandand the levels of public awareness in each country,

biosafety training programs were developed as well aspublic education and communications programs, based onthe existing capacities within the participating countries.

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Considering their higher level of development and expertisein biosafety and commercial agri-food biotechnology, themain training effort relied on institutions and experts fromCanada, the United States, Argentina, Brazil, Mxico andFrance mainly through seminars, courses and workshops.Besides this, valuable collaboration was provided by well-known national experts. Complementary technicalknowledge in areas which need to be reinforced are being

transferred to the corresponding national institutions.

Evaluation of the legal and institutionalinfrastructure in biosafety:

Specialized consultants developed studies in Colombia,Peru and Chile. They identified the national institutions andorganizations related to the formulation of biosafetyregulations, to the implementation of regulatory systemsand to the process of risk assessment and managementderived from the use of LMOs in human health, agriculture,food, livestock, animal health sectors and the environment.Furthermore, the national studies included analyses on the

interpretation and use of the precautionary approach in thecountry and a revision of the experiences andmethodologies employed in other countries for theevaluation of LMO-derived socioeconomic impacts. During2003 similar activities are carrying out in Panama, ElSalvador, Costa Rica, Jamaica, Grenade and Trinidad andTobago.

The Colombian study identified the institutions andorganizations related to the design and implementing

biosafety regulations, regulatory systems, and assessing andmanaging the risks derived from the use of LMOs in thehuman health, agriculture and livestock, food andenvironmental sectors. A comparison was carried out

between the Colombian provisions in force and the articlesof the Biosafety Protocol, and the shortcomings of thenational norms to comply with the requirements of theProtocol were identified. An analysis on the interpretationand use of the precautionary approach was performed and,finally, the methodological experiences of other countriesfor the evaluation of socioeconomic impacts derived fromthe use of LMOs were revised.

Peru presented a study in which the legal and institutionalbiosafety infrastructure in the agricultural, livestock andforestry sectors are characterized. A comparative study withthe legislation of other Latin American countries, among

them Argentina, Bolivia, Brazil and Colombia, was alsocarried out. Finally, a revision on the use of theprecautionary principle in the legislation and on themethodologies used for the analysis of the socioeconomicimpact in Brazil, Argentina and the U.S., was carried out.

In the case of Chile, the study included a revision of thebiosafety regulatory frame, both at the national and theinternational level. A comparison was made between theChilean provisions in force and the clauses of the BiosafetyProtocol. The shortcomings in the national legislation were

identified so as to comply with the demands of the Protocol.Concerning the precautionary principle, its enforcementwas reviewed in the Chilean law and some case studieswere examined. Finally, three studies were carried out that

partly analyzed the socioeconomic impact derived from thecultivation of LMOs. The results were most satisfactory. Inthe three countries it was possible to establish a biosafetyregulatory baseline by means of the revision of the legal

and institutional infrastructure. The regulatoryshortcomings vis--vis the Biosafety Protocol wereidentified and proposals were conceived to improve them.The application level of the precautionary approach toLMOs was established (in general, none of the threecountries presents cases of direct application of this

principle to LMOs).

Concerning the socioeconomic impact, all three countrieswere able to identify the requirements for the establishmentof appropriate methodologies at the national level. In thecase of Colombia, the study proposes an overall, clear

policy within a national regulatory frame that must consider

the countrys inherent conditions and also be congruentwith the different international agreements signed indifferent sectors. A dispersed normativity was detected,which might produce negative effects when applied,leading to a breach of provisions. In Peru, the existence of aBiosafety Law and Regulation was confirmed, althoughsome articles need to be revised to comply with theProtocol.

In Chile there is also a great dispersion both in theregulations and in the responsibility related to the subject of

biosafety in LMOs. Although no national policy forbiosafety exists, according to the initiatives that are being

carried out, the Chilean option seems to become a countrythat produces, imports and exports LMOs (ANPROS). Thedeveloped regulations comprise only the agricultural sectorand do not regulate all phases of LMO development.Finally, it has been concluded the convenience of includingthe concept of precaution as an approach but not as ageneral legal principle, since the Precautionary Principle islimited to environmental matters.

The studies carried out in each country were:

Colombia:Biosafety Regulations in Colombia within theframework of the International Biosafety

Protocol.Authors: Efrn Danilo Ariza, Mara SusanaCarrizosa and Juan Carlos Rodrguez.

Peru: Legal and Institutional Infrastructure in Peru.Author: Dora Pariona.

Chile: Biosafety Regulations in Chile within theframework of the Cartagena Protocol. Authors: LionelGil, Vctor Martnez, CamBioTec-Chile.

Biosafety training needs

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Assessment studies were carried out in the three countriesin order to determine the training needs. The Colombianstudy assessed the capacities related to risk assessment andcontrol. Information management and public perception of

biotechnology were also considered. The analysis wasbased on information generated by the InterministerialWorking Group in Biosafety.

In Peru, the results of a survey to researchers andrepresentatives of institutions (members of the NationalBiosafety Group) allowed the detection of specific needs in

public and private institutions in the area of implementationof biosafety regulation systems for LMOs, risk assessmentand management, technical and scientific assistanceservices and systems of information exchange.

In Chile, the training needs of human resources and theexisting biosafety infrastructure were assessed. Data wasobtained identifying the neeeds in informationmanagement. Pre- and postgraduate professional andacademic careers in the subject of biotechnology were

evaluated. It was also established that one of the mainhandicaps of in research and development on biosafety isthe limited infrastructure and human resources in the areasof plant and animal molecular biology and geneticengineering.

In Colombia, it was identified the need to work based ontarget institutions, such as ministries and regulatoryinstitutions, the National Technical Biosafety Councils(agricultural and livestock), technical teams, opinionforming groups, civil society and non-governmentalorganizations (NGOs). Among the training tools areinformative courses, high level courses, training courses,internships and workshops. Risk assessment capacities have

not reached the required level, and the structuring of a nodeof institutions of excellence is needed to support theregulatory agencies.

In Peru, the most important training needs include the newscience and technology knowledge related to LMOs, riskmanagement in all spheres (environmental and health),methods for detecting LMOs and for determiningsocioeconomic impacts. The needs for regulations related tothe transborder movement of LMOs and for improvingcommunication with the public were also detected, and,finally, the importance of developing short- and long-termtraining programs for regulatory agencies and for the

reinforcement of secondary and university education,respectively, were established.

In Chile, the training requirements are related to thoseindividuals who are in charge of training in the regulatoryagencies, who will use the regulatory tools put at theirdisposal. This type of work calls for professionals with afull-time dedication to biosafety and biotechnology withinthese agencies. Competence is also lacking in informationhandling. Shortcomings were also found in riskcommunication and in the benefits of biotechnology to

society. The studies carried out in each country are listedbelow.

Colombia:Biosafety Regulations in Colombia within theframework of the International Biosafety

Protocol.Authors: Efrn Danilo Ariza, Mara SusanaCarrizosa and Juan Carlos Rodrguez.

Peru:Training needs in Peru. Author: Iris Verastegui.Chile: Overview of Biotechnology in Chile. Chapters:Requirements for Implementing the Protocol andTraining of Human Resources. Authors: Lionel Gil, UtzDornberger, and Vctor Martnez.

Seminar-Workshops

An itinerant seminar was carried out in Chile, Peru andColombia, with the participation of nine foreign expertsfrom Argentina, Brazil, the United States, France andMexico. The experience of national researchers andacademics, who presented a special view of the situation of

biotechnology and biosafety in each of their countries, wasalso included in the local agendas.

In Chile the objectives were: to make information availableto decision-makers, to assess Chiles strong and weak

points concerning the Biosafety Protocol, and to trainofficers, decision-makers and researchers, by means of theevent itself and two satellite courses. A point worthstressing was the ample coverage of the event by thecommunication media, a fact which contributed to improvethe publics level of perception about biotechnology and theLMOs. The target public were controllers, inspectors,researchers, the media and the general public.

In Peru, the main objective was to train professionals,researchers and technicians in the principles of riskassessment and management of transgenic materials and inthe regulatory frames that support them. Main participantswere government officers, i.e. professionals fromSENASA, INIA, and other institutions belonging to the

National Biosafety Group.

In Colombia, the workshop was aimed at governmentofficers, especially at members of the institutionsresponsible for biosafety legislation, at members of the

National Technical Biosafety Committees, both agriculturaland livestock, and at members of the academic and

productive sectors. The main objective of the workshop wasthat of opening spaces for discussion between governmentorganisms and the academic and productive sectors.

The series of three events was attended by approximately360 people (100 in Colombia, 60 in Peru and 200 in Chile).For each of the events a CD was recorded with the

presentations of the experts attending the seminar. This willexpedite spreading of the information to the public. Thefinal discussion tables in each country, allowed for the

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elaboration of recommendations which may serve asbackup documents in decision-making related to thebiosafety of LMOs. Press covering was greater in Chile,where national and international experts were interviewed

by written, radio and television media, allowing for agreater coverage of the events objectives. The importanceof the participation of members of Congress and ofGovernment representatives in the Seminars must be

stressed, as it provides evidence of the national interest fortaking effective measures in biotechnology matters. InChile, the satellite courses permitted the training ofapproximately 30 professionals in the subject of detectionof LMOs in foods and seeds and in the evaluation andmanagement of risks derived from the use of LMOs.

General outline for national biosafety trainingprograms

On the basis of the consultancy studies and the conclusionsand recommendations of the national seminars, additionalrecommendations were formulated to complement the

existing biosafety regulatory system model, by filling ingaps, omissions or lapses. Furthermore, a specific biosafetytraining program is being designed for Chile, Peru andColombia taking into consideration the national objectivesin biotechnology, adapting the needs to the potentialtraining offer existing at the local, regional, and moredeveloped countries level, mainly Canada. Specially, the

proposed program includes training in:

(i) The implementation of regulatory systems for LMOsand by-products;

(ii) Risk assessment and management, related to the use ofLMOs and their by-products;

(iii) Technical and scientific assistance in risk assessmentand management due to the use of LMOs and by-products;

(iv) Systems of information exchange, informationdissemination and public education in biosafety of LMO

by-products.

DISCUSSION

Precautionary Principle: Due to the absence of relevantexperiences in the participating countries, the studiesrelated to the application of this principle described generalaspects in other countries, or were limited to cases related

to species not genetically modified (i.e. introduction ofFusarium oxysporum, bivalves of the family Pteriidae, andvariaties of Tilapia in Colombia).

Socioeconomic Impact: Due to the absence of legislationand experiences relevant to the subject in the participatingcountries, the analyses on methodologies were limited tostatements of a general character in Colombia, to a briefrevision of the situation in other American countries on the

part of Peru, and to the economic and labour impact oftransgenic seed production in Chile.

Interinstitutional Coordination: Some difficulties ininterinstitutional coordination at a national level wereobserved for the design of policies, the carrying out ofstudies and the provision of consultantships to decision-makers, due to scanty communication between agenciesand the public sector. There is a need to reinforce thecarrying out of permanent interinstitutional workshopsaimed at defining clear overall policies at a national level in

matters related to LMOs. At this respect, we draw attentionto the recent creation, in Chile, of the National Commissionfor the Development of Biotechnology.

CONCLUDING REMARKS

The project Biosafety Regulations in Latin America andThe Caribbean within the Frame of the InternationalBiosafety Protocol has given rise to the first coordinatedand systematic effort of training in biosafety, thus

becoming a pioneering project, complementary to the GEF(Global Environmental Facility). The OAS project whichstarted in Chile, Colombia and Peru has been extended to

six other countries from Central America and Caribbean. Ithas also provided the possibility of drawing up an inventoryof the strengths and weaknesses of the national regulatorysystems, determine the specific training needs and designgeneral outlines of biosafety training plans, which willcontribute to an efficient implementation of theInternational Biosafety Protocol or Cartagena Protocol,once the three countries have ratified it. On the other hand,the project has allowed to assemble, around discussiontables, international experts with the main representativesof regulatory and academic institutions, business enterprisesand NGOs, as well as with the best informed congressmenin scientific and technological matters and the protection of

biodiversity. Thus, the project has permitted theestablishment of cooperation linkages and has contributedto reinforce the notion of the importance of biosafety fornational development and the preservation of local

biodiversity.

The technical and scientific institutions involved inbiosafety are expected to offer congressmen all technicalassistance needed so as to guide them in well groundeddecision-making, specially in the following: determinationof the general principles on which a biosafety policy and anational legislation in this matter must be based; assessmentof the competences and faculties of public authorities;establishment of the authorization mechanisms

corresponding to each activity involving LMOs; thepossible adoption of an identification and labeling system;and the adoption of a liability system for the presumabledamages that can be caused through LMOs.

At this respect, the discussions of the seminar-workshopcarried out in Peru supported the recommendation of the

National Biosafety Group to the Congress of the Republicto rule out the project of law that forbid the import, use,marketing and sowing of LMOs. During the developmentof the project, the Chilean government, with the purpose of

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boosting biotechnology in the country, created the NationalCommission for Biotechnology Development (August2002), a fact which allows the results of the project to be agood source of information for defining a national policy in

biotechnology which will integrate political, social, ethical,health, environmental and biosafety aspects.

In Colombia, the consultancy studies allowed to review the

ex-ante or ex-postmethodologies and experiences used inother countries to assess the socioeconomic impacts ofLMOs on the biodiversity, considering the values of theindigenous and local communities.

The biosafety regulations must not be converted into cover-up barriers for the trade of LMOs, and also they must be inaccordance with other legal bodies which regulate relatedaspects. These regulations must be flexible and dynamic to

be able to respond to both the national and the internationaldemands. The experience in other countries indicates thatthe more general aspects of biosafety must be regulated bya law, while the more technical aspects (and which

consequently are subject to greater possibilities of change),should be regulated administratively. It is also necessary todetermine the coverage of this legal framework (generalapplication or by specific sectors). Regulations must takeinto account both the risks and the potential benefitsinvolved by LMOs. Ecological, economic, scientific,cultural, religious and other impacts must be considered.The concept of acceptable risk level must be incorporatedinto the legislation to confront the probability of theoccurrence of a risk and its consequences. Also, it isconvenient to incorporate the concept of precaution as a

perspective, and not as a general legal principle, becausethe Precautionary Principle is circumscribed toenvironmental matters and is not of a general nature.

It is absolutely necessary to base the invoking of theprecautionary principle or approach on an analysis ofprevious risks, based on scientific evidence, which allows acase to case identification of the existence of risks thatcannot yet be determined. If sufficient scientific evidencedoes not exist, provisional precautionary measures could beadopted, which would be exceptional and subject torevision. It is important to involve the opinion of all actorsduring decision processes. For this purpose, it is crucial toestablish a strategy of clear communication between civilsociety, the scientists, regulatory organisms and decision-makers. Therefore, a wide-ranging, unrestricted,

unprejudiced debate has to be encouraged, which will coverall relevant matters. Biosafety is a discipline which israpidly evolving, and which is fundamental for thedevelopment of biotechnology on a national level.Therefore, training in this matter is of the utmostimportance, considering the special needs of the LatinAmerican countries, both in relation to native biodiversityand the local environmental setting as to the need of

promoting national biotechnological innovations.

It is recommended to support the establishment of nationalbiosafety information networks which should includeinstitutions from the public and private sector anduniversities. It is also convenient to support thedevelopment of biosafety training programs aimed at suchareas as: introduction to biosafety of LMOs, molecular and

phenotypic characterization of LMOs, interaction betweenLMOs and the environment, interaction between LMOs and

health, biosafety of genetically modified microorganismsand social, economic and legal aspects of LMOs. Researchin the areas of biosafety must have common objectives andfollow the general guidelines established by the national

policy of each country. The studies carried out show thatthe public has been induced to perceive LMOs in a negativeform. However, important international institutions such asFAO, WHO and the national academies of science ofseveral countries have concluded that the foods derivedfrom LMOs are as safe or safer than their traditionalcounterparts.

The cultural factor is of great relevance when establishing

the strategy with which the public will be faced. Thus, it isimportant to work with the communicators, who should bequalified to comprehend the scientific facts, and thereafter,to transmit the information in a way that will be easilyunderstood by the general public. In order to improveinformation to the public, it is necessary to elaborate acommunicational strategy based on simple messages. Thesemust explain the potential that biotechnology represents tothe benefit of the country.

Information on the biosafety system must also be provided,especially about: who are responsible, how are decisionsmade, how is information updated, and how the public can

participate. Within this strategy, it must be acknowledgedthat the debate is not only about science, but also covers

political, ideological, religious and ethical aspects. It mustbe stressed that in the development of this projectcommunication channels have been opened with decision-makers so as to obtain the updated scientific and technicalinformation needed as best support for the policies andlegislation related to biotechnology and biosafety.

It is necessary to continue the studies on public perceptionof modern biotechnology in order to compare the facts andthe evolution that this matter has undergone through theyears. Research on LMOs in Latin America and theCaribbean must be promoted starting now, so as to have a

timely access to the market at the moment when marketingof this type of crop be massified. The global trend leadstoward a greater acceptance of LMO cultivation, a reasonwhy we cannot wait until the last moment for carrying outresearch in our countries.

The biotechnological and organic options do not seem to benecessarily exclusory, as has been set out so far.International experience shows that all these options are

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feasible and complementary. Market recesses which existfor these two options can be taken advantage of, thusimproving profit margin of agricultural production. Theneeds and possibility have to be studied for implementingsegregation of these crops. These studies have to be carriedout considering the characteristics of the variety (type of

pollinization, distance, existence of wild relatives, etc.).

Countries having similar characteristics must work on aregional biosafety model, with the purpose of standardizing

procedures. Thus, the information that each one of theparties delivers at the moment of confronting situations notcontemplated in the Biosafety Protocol, can be validated.Various strategies have been set forth to make the most ofthe different advances in regulatory aspects, humanresources and physical infrastructure. For this purpose it isnecessary to develop international North-South cooperationand, very specially, regional cooperation. It is convenient toexplore the possibility of establishing an aligned andofficially approved system with neighboring countries forthe evaluation and acceptance of LMOs, so that the high

costs of the required experimental trials do not constitute abarrier to the development of LMOs in the region. Takinginto account that the International Biosafety Protocol enterinto force. during the year 2003, it is urgent to establishnational regulatory systems and build up nationalcompetence for successfully taking on the new challengesdemanded by these circumstances, which have deepimplications in international trade.

The OAS Biosafety Project provides an excellentopportunity for training the different actors involved in thisarea in the participating countries, and opens new

possibilities of cooperation at a regional level to strengthenthe biosafety programs. At the same time, the experienceacquired may act as a model for other countries of theregion that urgently require to reply to the implementationof the protocol. Conscious of this responsibility,CamBioTec and the OAS are working on the initiative ofimplementing a training program based on the informationand experience acquired during the development of this

project. Finally as a project product, a book entitled:Biosafety and the International Commerce of TransgenicsFood in the Americas: Decisions and Challenges, Eds: L.Gil and V. Martnez. Andros Impresores, ISBN 956-291-992-7, 433 pp, has been published in December 2003,which provide a wide overview of the work done in this

project. The book addressed to industry, government

regulators, parliament members, academia and consumersgroups contains 34 articles written by experts from:Argentina, Brasil, Colombia, Chile, France, Mexico, Peru,and USA, covering aspects such as: Biosafety Frameworkand Policies, The Cartagena Protocol and the NationalRegulatory Systems, Risk Management and RiskAssessment, GMOs introduction and Socio-economicImpacts, Building Capacity in Agricultural Biosafety andPublic Awareness and Communication.

REFERENCES

DELLACHA, J. and VERASTEGUI, J. Evaluacin,manejo de riesgo y percepcin pblica en biotecnologa

agrcola. Actas de Seminarios del Proyecto CIDA enArgentina, Buenos Aires, marzo 2000.

FLINT, J.; GIL, L.; VERASTEGUI, J.; IRARRZABAL,

C. and DELLACHA, J. Biosafety information managementsystems. A comparative analysis of the regulatory systemsin Canada, Argentina, and Chile. Electronic Journal of

Biotechnology [online]. 15 April 2000, vol. 3, no. 1, [30April, 2000]. Available from Internet:http://www.ejbiotechnology.info/content/vol3/issue1/full/2/index.html. ISSN 0717 3458.

GRACE, Eric S.La Biotecnologa al Desnudo. Barcelona,Espaa, Editorial Anagrama, 1998, p. 299. ISBN:8433905554.

GIL, L. and IRARRZABAL, C. OGMs: Produccin,comercializacin, bioseguridad, percepcin pblica.Andros Impresores. 2001. 254 p. ISBN 956-288-896-7.

VERSTEGUI, J. Transferring Expertise and BuildingCapacities in Biotechnology: the Experience ofCamBioTec, in Biotechnology and Development. Monitorno. 39, Amsterdam, September 1999, p. 2-7.

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