In 2002 the Organization of American States (OAS) approved the project: "Biosafety Regulations in Latin America and the Caribbean within the framework of the International Biosafety Protocol". Participant countries were: Chile, Colombia, Peru, Panama, El Salvador, Costa Rica, Jamaica, Grenade and Trinidad and Tobago. The general objective of this project was to strengthen national skills for the assessment and management of risks of biotechnology food products, and to build up public awareness about the benefits provided by these foods, with the ultimate goal to promote their safe and sustainable use within a protective and trusting environment for the public. The specific objectives included: a) to evaluate the legal and institutional infrastructure existing in the participant countries in compliance with the International Biosafety Protocol; b) to establish the training needs of the different social actors with the purpose of ensuring their proper qualifications for enforcing the International Biosafety Protocol of Cartagena; c) to organize biosafety seminar-workshops in different countries for the purpose of making the institutions in charge of the implementation of the biosafety regulations and of the Cartagena Protocol become consciously aware of the existing problems and of the need for training of their personnel and d) to elaborate the general outlines for national training programs in  biotechnology biosafety.

The project promote both North-South and South-South cooperation. Starting from the characterization of the national regulatory systems, the identification of training supply and demand and the levels of public awareness in each country. Biosafety training programs were developed as well as public education and communications programs, based on the existing capacities within the participating countries. Considering their higher level of development and expertise in biosafety and commercial agri-food biotechnology, the main training effort relied on institutions and experts from Canada, the United States, Argentina, Brazil, México and France mainly through seminars, courses and workshops. Besides this, valuable collaboration was provided by well-known national experts. Complementary technical knowledge in areas which need to be reinforced are being transferred to the corresponding national institutions.

Evaluation of the legal and institutional infrastructure in biosafety

Specialized consultants developed studies in Colombia, Peru, Chile and in 6 countries from Central America and the Caribbean Region. The studies identified the national institutions and organizations related to the formulation of biosafety regulations, to the implementation of regulatory systems and to the process of risk assessment and management derived from the use of LMOs in human health, agriculture, food, livestock, animal health sectors and the environment. They also included review and discussion on the interpretation and use of the precautionary approach, and a revision of the experiences and methodologies employed for the evaluation of LMO-derived socioeconomic impacts. A comparison was carried out between the local regulations and the articles of the Biosafety Protocol, and the shortcomings of the national norms to comply with the requirements of the Protocol were identified.

Concerning the socioeconomic impact in Colombia, Chile and Peru the studies were able to identify the requirements for the establishment of appropriate methodologies at the national level. In the case of Colombia, the study proposes an overall, clear policy within a national regulatory frame that must consider the country's inherent conditions and also be congruent with the different international agreements signed in different sectors. A dispersed normatively was detected, which might produce negative effects when applied, leading to a breach of provisions. In Peru, the existence of a Biosafety Law and Regulation was confirmed, although some articles need to be revised to comply with the Protocol. In Chile there is also a great dispersion both in the regulations and in the responsibility related to the subject of biosafety in LMOs. According to the initiatives that are being carried out, the Chilean option seems to become a country that produces, imports and exports LMOs. The developed regulations comprise only the agricultural sector and do not regulate all phases of LMO development. It has been concluded the convenience of including the concept of precaution as an approach but not as a general legal principle, since the Precautionary Principle is limited to environmental matters. Recently due to a recommendation of National Commission for Biotechnology Development of it has been created a Regulatory Commission to coordinate the activities of the public institutions related to regulations in biotechnology and it has been also created the National Forum of Biotechnology to stimulate the public debate about Biosafety and the new challenges in biotechnology.

Biosafety training needs

In Colombia the study assessed the capacities related to risk assessment and control. Information management and public perception of biotechnology were also considered. The analysis was based on information generated by the Interministerial Working Group in Biosafety. It was identified the need to work based on target institutions, such as ministries and regulatory institutions, the National Technical Biosafety Councils (agricultural and livestock), technical teams, opinion forming groups, civil society and non-governmental organizations (NGOs). Among the training tools are informative courses, high level courses, training courses, internships and workshops. Risk assessment capacities have not reached the required level, and the structuring of a node of institutions of excellence is needed to support the regulatory agencies. In Peru, the results of a survey to researchers and representatives of institutions (members of the National Biosafety Group) allowed the detection of specific needs in public and private institutions in the area of implementation of biosafety regulation systems for LMOs, risk assessment and management, technical and scientific assistance services and systems of information exchange. The most important training needs include the new science and technology knowledge related to LMOs, risk management in all spheres (environmental and health), methods for detecting LMOs and for determining socioeconomic impacts. The needs for regulations related to the transborder movement of LMOs and for improving communication with the public were also detected, and, finally, the importance of developing short- and long-term training programs for regulatory agencies and for the reinforcement of secondary and university education, respectively, were established. In Chile, the training needs of human resources and the existing biosafety infrastructure were assessed. Data was obtained identifying the needs in information management. Pre- and postgraduate professional and academic careers in the subject of biotechnology were evaluated. It was also established that one of the main handicaps in research and development on biosafety is the limited infrastructure and human resources in the areas of plant and animal molecular biology and genetic engineering. The training requirements are related to those individuals who are in charge of training in the regulatory agencies, who will use the regulatory tools put at their disposal. It was concluded a need of professionals well trained with a full-time dedication to biosafety and biotechnology within these agencies. Competence is also lacking in information handling. Shortcomings were also found in risk communication and in the benefits of biotechnology to society.

Seminar-Workshops

Seminars were carried out in Chile, Peru, Colombia, and in Venezuela (only for Central America and Caribbean countries) with the participation of 25 experts from Argentina, Brazil, the United States, France, Mexico and United Kingdom in addition to local experts. The experience of national researchers and academics, who presented a special view of the situation of biotechnology and biosafety in each of their countries, was also included in the local agendas. The series of events was attended by approximately 420 people (100 in Colombia, 60 in Peru, 200 in Chile and 60 in Venezuela). For each of the events a CD was recorded with the presentations of the experts attending the seminars. This will expedite spreading of the information to the public. The final discussion tables in each country, allowed for the elaboration of recommendations which may serve as backup documents in decision-making related to the biosafety of LMOs. Press covering was greater in Chile, where national and international experts were interviewed by written, radio and television media, allowing for a greater coverage of the event's objectives. The importance of the participation of members of Congress and of Government representatives in the Seminars must be stressed, as it provides evidence of the national interest for taking effective measures in biotechnology matters. In Chile, the satellite courses permitted the training of approximately 30 professionals in the subject of detection of LMOs in foods and seeds and in the evaluation and management of risks derived from the use of LMOs.

General outline for national biosafety training programs

On the basis of the consultancy studies and the conclusions and recommendations of the national seminars, additional recommendations were formulated to complement the existing biosafety regulatory system model, by filling in gaps, omissions or lapses. Furthermore, a specific biosafety training program is being designed taking into consideration the national objectives in biotechnology, adapting the needs to the potential training offer existing at the local, regional, and more developed countries' level, mainly Canada and USA. Specially, the proposed program includes training in:

a) the implementation of regulatory systems for LMOs and by-products; b) risk assessment and management, related to the use of LMOs and their by-products; c) technical and scientific assistance in risk assessment and management due to the use of LMOs and by-products and d) systems of information exchange, information dissemination and public education in biosafety of LMO by-products.

Conclussions

The project has given rise to the first coordinated and systematic effort of training in biosafety, thus becoming a pioneering project. It has also provided the possibility of drawing up an inventory of the strengths and weaknesses of the national regulatory systems, determine the specific training needs and design general outlines of biosafety training plans, which will contribute to an efficient implementation of the International Biosafety Protocol, once the countries have ratified it. 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 the best informed 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 the importance of biosafety for national development and the preservation of local biodiversity.

Discussions of the seminar-workshops carried out in Peru supported the recommendation of the National Biosafety Group to the Congress of the Republic to rule out the project of law that forbid the import, use, marketing and sowing of LMOs. During the development of the project, the Chilean government, with the purpose of boosting biotechnology in the country, created the National Commission for Biotechnology Development a fact which allows the results of the project to be a good source of information for defining a national policy in biotechnology which will integrate political, social, ethical, health, environmental and biosafety aspects. Other recommendations of the Seminar-workshops were: the biosafety regulations must not be converted into cover-up barriers for the trade of LMOs, and also they must be in accordance with other legal bodies which regulate related aspects. These regulations must be flexible and dynamic to be able to respond to both the national and the international demands. Regulations must take into account both the risks and the potential benefits involved by LMOs. Ecological, economic, scientific, cultural, religious and other impacts must be considered. The concept of "acceptable risk level" must be incorporated into the legislation to confront the probability of the occurrence of a risk and its consequences. Also, it is convenient to incorporate the concept of "precaution" as a perspective, and not as a general legal principle, because the Precautionary Principle is circumscribed to environmental matters and is not of a general nature.

It was also recommended to support the development of biosafety training programs aimed at such areas as: introduction to biosafety of LMOs, molecular and phenotypic characterization of LMOs, interaction between LMOs and the environment, interaction between LMOs and health, biosafety of genetically modified microorganisms and social, economic and legal aspects of LMOs. Research in the areas of biosafety must have common objectives and follow the general guidelines established by the national policy of each country. The studies carried out show that the public has been induced to perceive LMOs in a negative form, although important international institutions such as FAO, WHO and the National Academies of Sciences of several countries have concluded that the foods derived from LMOs are as safe or safer than their traditional counterparts.

Countries having similar characteristics must work on a regional biosafety model, with the purpose of standardizing procedures. Thus, the information that each one of the parties delivers at the moment of confronting situations not contemplated in the Biosafety Protocol, can be validated. Various strategies have been set forth to make the most of the different advances in regulatory aspects, human resources and physical infrastructure. For this purpose it is necessary to develop international North-South cooperation and, very specially, regional cooperation. It is convenient to explore the possibility of establishing an aligned and officially approved system with neighboring countries for the evaluation and acceptance of LMOs, so that the high costs of the required experimental trials do not constitute a barrier to the development of LMOs in the region. Taking into account that the International Biosafety Protocol entered into force. September 2003, it is urgent to establish national regulatory systems and build up national competence for successfully taking on the new challenges demanded by these circumstances, which have deep implications in international trade.

The OAS Biosafety Project provides an excellent opportunity for training the different actors involved in this area, and opens new possibilities of cooperation at a regional level to strengthen the biosafety programs. At the same time, the experience acquired may act as a model for other countries of the region that urgently require to reply to the implementation of the protocol. Based on the information and experience acquired during the development of this project, we presented to OAS a new project to build capacities in Biotechnology Biosafety in the Region, including 15 countries. The project has been recently approved for the period 2004-2006 and include include Courses and Seminars in Risk Assessment and Risk Management, DNA Analysis and Traceability, Management, Innovation and Marketing in Biotechnology, as well as Seminars in Public Awareness. Finally, as another project product, a book entitled: Biosafety and the International Commerce of Transgenics Food in the Americas: Decisions and Challenges, Eds: L. Gil and V. Martinez. Andros Impresores, ISBN 956-291-992-7, 433 pp, has been published in December 2003. The publication provide a wide overview of the work done in this project. The book addressed to biotechnology related industry, government regulators, parliament members, academia and consumers groups contains 34 articles written by experts from: Argentina, Brazil, Colombia, Chile, France, Mexico, Peru, and USA, covering aspects such as: Biosafety Framework and Policies, The Cartagena Protocol and the National Regulatory Systems, Risk Management and Risk Assessment, GMOs introduction and Socio-economic Impacts, Building Capacity in Agricultural Biosafety and Public Awareness and Communication.