The Situation of Legal and Institutional Structure of Bio-security

San Salvador, October10th 2003

Angel Arturo Soto Pacheco
Coordinador de Proyectos
Consejo Nacional de Ciencia y Tecnología, CONACYT

Financial support: OAS Project number AE 145-01 "Biosafety Regulations in Latin America and The Caribbean within the framework of the International Biosafety Protocol".

Summary of actually Situation of Bio-security and Bio-Technology

El Salvador, although ratified the Convenient about Biological Diversity and the Agreement of Cartagena; Cartagena’s Protocol doesn’t have a regulation mark and a Structure that has a Capacity to guarantee the benefits of Modern Bio-Technology yet, However both documents make the bases to improve this operative institutional mark and legal given that the agree with our political constitution establish the primacy of international Treatments about Local Laws in the Art. 144 which simplifies and facilities the normative improvement related with bio-security, It could improve with prescribed legal instruments, which not requires the legal process that is more complicated, however if we considerate that more effort has to be done in the field of human structure as well as in the Institutional which requires of very important capacities, that to be efficient could be implemented with a coordinated effort of the countries that conform the Central America integration.

In this first advance review the situation of the institutional structure, legal and the proposes that are formulating to design the instruments and mechanism to start off the putting in use of the Cartagena Agreement.

Institutional Structure

Ministry of Economy

Promote the Economical and social Improvement By means of the increment of production, the productivity and the rational utilization of products.

To Contribute to the Improvement of competition, and Competitiveness of Productive Activities as much for the intern market as much for the extern.

Define the Commercial politic of the country, the Pursuit and Impulse to the Centro American Economic Integration, to fortify the flows of commerce and inversion and improvement of commercial negotiations with third countries and multilateral organisms.

To cause and to support the economic and social development of the country through joint design of economic policies with the private sector, considering the new forms of international trade and framing in a modern legal context that allows the action and respect of the legitimate Interests of the diverse economic agents and the good operation of the globalize markets.

Ministry of Agriculture and Cattle Raising

This Ministry of much tradition in El Salvador has much importance by the cattle importance that the agricultural activity has had and between its functions stand out the one to generate and to spread reliable and opportune information statistical relative to the production and commercialization of main products generated by the national land. Compile relative information to the international trade of the most excellent products in the national market. To prevent the introduction to the country of plagues and diseases that constitute damage the agriculture and the cattle ranch, identify and diagnose the main fito-zoo-toilets problems that affect agriculture and cattle ranch as well as to make studies of recognition and evaluation of such. Guard the fulfillment of the legal frame and execution of policies that regulate and orient the conservation and development of renewable the natural resources. Design and implement programs and projects that contribute to the sustainable development of renewable the natural resources that allow the rehabilitation, arrangement and integral handling of the hydrographic river basins of the country. Delimit and to conserve the selected protected areas, guarantee the permanence and conservation of the biodiversity.

Ministry of Environment and Natural Resources

The work of this Ministry closely is bound to the necessity to coordinate efforts for the execution of actions related to the protection of the environment and the sustainable handling of the natural resources, reason for which ties its work with all the sectors of the society; its organizational structure is based on an organization by processes, who allow him to reach objectives and goals in relatively short times thus existing three levels:

a) The advisory level

b) Services level

c) The operative level of the Ministry establishes three macro-processes, two nouns conformed by the directions of Natural Patrimony and Environment; that is added an macro-process link with the civil society that falls in Social Promotion and attention.

In complement, is had the interaction of the Ministry with the environmental units that are being created within the framework of the Law of Environment which they conform the National System of Management of the Environment (SINAMA), which has like purpose the establishing, putting into operation and the maintaining in the organizations and institutions of the public sector the principles, norms, programming, direction and coordination of the environmental management of the State (Art. 6, 7 and 8, LMA).

It is important to consider the paper that plays the national environmental Funds assigned to the MARN: The Environmental Fund of El Salvador (FONAES) and the Funds of the Initiative for the Americas of El Salvador (FIAES), in the environmental management and of natural resources  whose executive direction correspond to the Ministry, FONAES and FIAES have given amounts for the execution of projects to ONG's, municipalities, ADESCOS, foundations and associations on public service, with which were executed in the period a total of 126 projects with a USS5.5 investment million between both institutions, having itself directly favoured 640.000 inhabitants.

National Center of Farming and Forest Technology.

The mission of this center is being a technical scientific institution that we develop, promote and facilitate the investigation and farming and forest technological transference for the enterprise land conversion, and the long term vision is to be a leader institution in the Salvadoran system of farming and forest innovation.


To cause the availability of farming and forest technology, that allows the reconversion and the development of land business.

One of the developed Projects is “The fortification of the national center of farming and forest technology” in, matter of agricultural biotechnology, with the support of CYTED.


a)     To advise the ministry of agriculture and cattle ranch in the formulation of the national policy of the farming and forest scientific and technological development.

b)     Contribute to execute the national policy of farming and forest scientific and technological development.

c)      Develop the generation and transference of farming and forest technologies.

d)     To disclose profits and results of the investigation generated in the country or introduced with the purpose of facilitating the adoption of the appropriate technologies.

e)     To promote the generalized use of the technological options and the services of laboratory that supports the production.

f)        Support the formation of transference’s of farming and forest technology.

g)     To exert the pursuit to projects of investigation and transference subsidized by CENTA

Public Health Ministry and Social Attendance

The Ministry of Public Health and Social Attendance has like policies to Improve the effective access to the basic services in the matter of health, with emphasis in the health promotion in order to elevate the standard of life of the Salvadoran population in addition to being an instance of the governing State in the matter of health, that it guarantees to the inhabitants of El Salvador the cover of opportune and integral services, with fairness, quality and warmth, in co responsibility with the community, including all the social sectors and actors, to contribute to obtain a better quality of life.

Legal infrastructure

The legal, institutional infrastructure and of human resources in the matter of Bio security is very weak, because it has not been developed on the specific thematic.

By the previous thing a National Policy of Biotechnology and Bio security does not exist, understood this like defined objectives Plans, Programs and Projects, legitimized that count on their financial resources, if there is some implicit lineament in the national policies of Science and Technology and the environment.

The ratification in the Agreement of Cartagena and the Agreement on the Biological Diversity are something that is positive since the commitments and obligations can be fulfilled that settle down in those documents.

The Legislation of El Salvador appears next in detail related with the purpose of this document.

The first group of laws is related with the conservation and sustainable Use of the biological diversity, and it begins with the environment law.

In such sense, the Ministry of the environment and natural resources it is the guarantor of the fulfillment of the Law and Competent Authority in the Agreement of Biological Diversity, instrument of which the Cartagena Protocol arises and that also turns it in a focal point of the mentioned Protocol.

The second group of laws is related indeed to the human health, of its study it will be possible to determine as with the existing regulatory mechanisms related to guarantee the innoquity of foods: At the end of this group it will also be studied the Law of Protection to the Consumer.

In this Stage is determined that laws are had, what they regulate and how they do it, clarifying that some laws will not be retaken due to the antiquity of the same ones, example of it: The Law of  Industrial Promotion and the Regulating Law of the Exercise of trade and Industry.

Constitution of El Salvador

The Constitution of the republic establishes the principles that sustain the protection of the natural resources, since this is the base of our legal ordering, and from these principles its relation with the biotechnology and the bio security can be established. We will find this in the articles 101 inc. 2, 113,  60 inc. 2, 117, 65 inc. 1, 69,

Law and regulation of the environment

The Law and General Regulation of the environment does not contemplate Measures of bio security in explicit form, the Art.68. It establishes that the Ministry, with the support of specialized institutions, will apply the security norms to which will be to subject the resulting varieties of the human action by means of the biotechnology supervising its use in order to diminish the adverse impact on the native biological diversity.

These measures will be according to the Art.81 of the Regulation those mechanisms of contemplated regulation and control in the international instruments in the matter properly ratified in this case the contemplated measures of bio security in the PROTOCOL OF CARTAGENA will be retaken.

The word biotechnology and bio security is not defined in the Law, is recommended to incorporate them in the Art.5. of the law.

As far as the potential risks for the biological diversity that could display the OVM; The Law of environment does not mention it of express way.

The Law determines in the Literal Art.21 "ñ" the possibility that a project or industry of biotechnology or that implies the genetic handling or production of Alive Organisms Modified genetically.

The law does not contemplate the management of the Biotechnology; the only mention that is made on the matter is contemplated in literal Art.21 ñ and it talks about the possibility that a project or industry of biotechnology or that implies the genetic handling or production of Alive Organisms Modified genetically, wishes to work in El Salvador.

In relation to the investigation in the area of the biotechnology, it is not mentioned in an express way; it will be the MARN that will authorize or generate the studies and investigations of different types and categories that are made in the Protected Natural Areas.

As for the scientific research and technological, the environment law does not establish the search and implementation of the same one, what it  persecutes is the incorporation of the environmental dimension in all plan, programs and projects of science and technology Art.40.

Art. 68 of the Law makes reference to the biotechnology in general, is recommended that by means of Special Regulations the different types from biotechnology are ruled.

Law of conservation of wild life

The Law does not mention the use of the biotechnology as a possible technique to improve the form to use the wild species, nevertheless in literal Art.6 "c" determines that it is a function of the MARN, to make studies on new and better forms to use the wild species. Of equal way the Literal Art. "E", also determines that it is function of the MARN to make necessary studies and tests for the reproduction of the wild life for human use, as well as to recover and to conserve populations of those species or threats of extinction.

The Law does not make reference to safety measures before native species that can be modified genetically, through the biotechnology.

General Law of arrangement and promotion of fishing and aqua-ranch

The law does not mention the use of the biotechnology modern as possible technique to improve the form to use the hydro biologics resources, like the possibility of produced hydro biological species by means of this technique.

The law does not recognize bio security measures, recognizes sanitary requirements solely, in Art. 46.

In the case of the species either organisms that can be cultivated, the law does not establish the more requisite that not to prevent the workings of fishing and navigation (Art.51).

The Law solely recognizes the exigency of the Study of Environmental Impact for infrastructure works, does not recognize the necessity to evaluate the environmental impact of the import of species that do not belong to the native aquatic ecosystems.

It is recommended that the Law is extended and mainly knows the importance the inter-institutional coordination in security mechanisms before the possibility of import of alive hydro biological species for the direct consumption or to be cultivated.

It is recommended that the principle of precaution is extended, established in the Art.4, this is limited the faculty that the law offers CENDEPESCA, to establish temporary measures of arrangement, when it is not had pertinent the scientific information on the state of the hydro biological species.

The principle of Precaution does not make reference to the necessity of evaluations of risk as far as the effects in the conservation and the sustainable use of the aquatic species or the risks for the human health.

Forest law

The forest Law, does not contemplate to the modern biotechnology, as a technique that can favor the development of a forest industry, of equal way mentions bio security measures either, despite it contains measures oriented to the control of plagues and diseases (Art.29).

The Law does not contemplate any related aspect to the possible adverse effects that they could cause the OVM in the forest ecosystems.

It is important to mention that within the attributions of the MAG, some exist that can be very useful, (Art.4 of the Law), mainly when establishing the possible benefits and environmental risks in the use of OVM.

Law of vegetal and animal health

The Law does not make reference to measures of bio security before the possibility of the production or import of animals, vegetables or their products that can contain or have generated from OVM.

Nevertheless, the definition of (inputs) for established farming use in the Law, leaves the possibility that in the (inputs) can be included the biotechnological  materials, but the safety measures do not settle down before the possible risks that the biotechnology can imply in the human health and the biological diversity.

In relation to the definition of Analysis, it does not take into account the potential adverse effects that the biotechnological materials, could cause in the biological diversity and the human health.

The Law contemplates control mechanisms that could collaborate in providing information that helps in the complementation of the responsibilities that the Protocol of Cartagena leaves in charge of the States Part. It's referenced to the OVM for human or animal consumption.

Law of seeds

The law in Art. 30, prohibits the import, investigation, production and commercialization of trans-genic seeds; but it does not establish how it will control this import, how it verifies if the seeds are trans-genics, or which are the measures of bio security before a possible entrance of these seeds and the possible adverse effects of the OVM in the human health, the biological diversity and the agricultural production.

The Law does not define which must be understood by trans-genetic seed.

It is recommended to extend the Law in order to cover the exigencies that the control of the imports of  trans-genetics seeds requires, this extension also it will have to include the corresponding measures of bio security with the objective to diminish the possible adverse impacts in the biological diversity associated to the land ecosystems of the country.


The Law does not develop the lineament of Policy oriented to the Promotion of the Technological Innovation of the Capacity related to the ecology, agriculture, the health and the biotechnology.

The Law of CONACYT, favors the implementation of the Protocol of Cartagena, since it promotes the scientific and technological development, with the participation of all the productive, academic and professional sectors (Art.8).

It impels through different mechanisms, the legal ordering related to science and the technology (Art.5 "h").

It manages financial resources for the development of scientific and technological projects (Art.16 "m").

In addition, in same article 16 "r", the CONACYT puts under periodic evaluations the research programs in march, the management and the transference of technology.

The adoption of norms of the Codex Alimentarius of the FAO/OMS, on foods obtained by biotechnological means, is a profit for the Country, since it complements subjects non-boarded by the Protocol of Cartagena.

Law of creation of the National Center of Agricultural Technology (CENTA)

The Law of Creation of the CENTA, does not make reference to the modern biotechnology or the measures of bio security, but it could cause conditions that make possible the development of the same one in the farming scope, which is expressed in Art. 4 of the mentioned law.

Next the Second Group of Salvadorian Laws appears, related to the implementation of the Protocol of Cartagena on Security of the Biotechnology.

Code of health

The Law does not have measures of bio-security in the use or consumption of pharmaceutical products or foods that could contain OVM, but if it determines mechanisms, registries and controls that could support the control of the OVM and the possible adverse effects to the human health, (Art.10 and 11 of the mentioned Code).

It is responsibility of Ministry of Public Health to watch and to control the innocuousness of consumption products they are these nutritional, pharmaceutical or cosmetic ones; for it counts on a laboratory system that they have like mission:

Art.249. the Control of quality of products to that article 243 of this Code talks about will be in charge of the Ministry. In I articulate 244 speaks to us of the quality norms that stable in Code for products mentioned in I articulate 243, for which it stops to

verify their fulfillment were made the established analysis in I articulate 245 which will be in charge of the Laboratory of Control of quality (253-257 I code of health).

The Superior Council of Health is the person in charge according to the Art.246- TO AUTHORIZE the INSCRIPTION, MANUFACTURE, IMPORT and dispensation of pharmaceutical specialties of any nature that are, mattered or made in the country.

The previous Article is complemented with the Art.247. Which determines that the inscription is previous to the import, manufacture and spend of a pharmaceutical product for human or veterinary use.

By the nature of the Laws related to health, it is recommended not to modify the Law But to develop special regulations that contain the corresponding measures of bio security, as much for pharmaceutical products, nutritional innocuousness and veterinary products.

Law of protection to the consumer

The Law does not make special mention of generated nutritional products from an OVM.

The Law, does not make reference to measures of bio security; nevertheless it counts on some controls that could be of aid at the time of making decisions with respect to allow the product import that could be produced by means of the modern biotechnology, makes reference to (literal Art.5 g.).

The inter-institutional coordination that supposes the fulfillment of the mentioned law is a strength that could be of aid in the implementation of the Protocol of Cartagena.

The Objective of the Law of protection to the consumer, is the protection of the Rights of the Consumer, the previous thing constitutes a strength of Country in the implementation of the Protocol of Cartagena, since it develops through different mechanisms, controls and procedures the regulation of the import, quality and innocuousness of the consumer goods, as it establishes the Art.5, literal g); Art.7 literal a), b); Art.9; Art.10 and Art.12.

The Objective of the Law of protection to the consumer, is the protection of the Rights of the Consumer, the previous thing constitutes a strength of Country in the implementation of the Protocol of Cartagena, since it develops through different mechanisms, controls and procedures the regulation of the import, quality and innocuousness of the consumer goods, as it establishes the Art.5, literal g); Art.7 literal a), b); Art.9; Art.10 and Art.12.

It is recommended that the Art.7 of the Law related to the rights of the Consumer incorporates ample information on foods or prime materials that have been produced by means of the modern biotechnology.

Conclusions on the legal frame

As it is possible to be appreciated of the description of the effective Legislation at the present time in El Salvador it exists very basic a legislative regulation and lacks to develop the legal frame that can make possible the application in the Agreement of Cartagena on Bio security and like consequence to benefit from the advances of the Biotechnology.

A summary of which it considers in perspective is the following one.

According to interviews made to the civil employees of the Ministry of the environmentand Natural Resources.

Bio security policy

Still a Policy of Bio security has not been defined and it is tried that it within the framework defines of the NATIONAL ADVICE OF SCIENCE and TECHNOLOGY, although is the Ministry of the Atmosphere and Natural Resources she is the person in charge of the execution of the policy of Bio security, which is taken as departure point for the definition of the Policy of Bio security is the take effect in the Agreement of Cartagena document, according to the analyses of the policy that has elaborated the Ministry of the Atmosphere the policy that thinks to propose has the following lineament:

  • To protect and to diminish the impact that the OVM can have on the health, Agriculture and the environment.

Authority competent

The competent Organism is the Ministry of the Atmosphere, although it is recognized that other organisms exist and institutions that have competitions you specify, reason why in the phase of implementation of the policy it is recommended that it is a collegiate organism, is to say a species of Committee of Bio security.

Collegiate organism

It is considered that the operability of the policy is arranged by a collegiate organ the Committee of Bio security that will be integrated by the Organisms of the State related to the Policy of Agriculture, environment, Health, Fishing, Science and Technology, to this organ will include the deprived sectors, of Universities and ONG related to the thematic one.

Organisms responsible for the authorizations

The regulation that delay has an operation in the future related to the authorizations of entrance, commercialization, export and import of the OVM will be those that have by competition the responsibility of you transact related to the Sector which it is based on the present legislation, the present legislation authorizes competition to them to these institutions to authorize the related thing to the aspects and mentioned sectors, the proposal for the related thing to the thematic one of the organism with genetic modification, would be by means of regulations and procedures that develop the principles that settle down the Agreement of Cartagena.

Despite previous the national focal organism for effect of the international communications it will be the Ministry of the Atmosphere and Natural Resources.

Mechanisms for the administration of the risk

At the moment the 25 of December of the 2003 have not been designed nor implemented mechanisms for the administration of the risk is tried in the heat of to implement once between use the Agreement of Cartagena.


The competent Authorities in agreement their legal endorsement will be the people in charge to authorize:

The Registry of Laboratories, also in this case is tried that the laboratories properly are credited for the international norms of the ISO the Registry of the Investigations.

The product Registry

The Liberation of the OGM, will be made by authorization of the Competent Ministry and with monitored and pursuit of such.

Movements trans-frontier

The Authorizations of the trans-frontier movements will be authorized by the competent organisms according to the in question matter which will be regulated by the respective regulation that develops the thematic one in the Agreement of Cartagena.

Requirements of qualification and formation of human resources

The subjects in which it is required of a greater demand of qualification refer the subjects that are mentioned next:

In relation to subjects of fortification of the institutional capacities:

  • Management of the Regulatory and normative structure
  • Elaboration of the Lineaments de Politic
  • Management of the Scientific research and technological
  • Management of the resources of Computer science and communications
  • Handling of the financial resources and monitored of projects
  • Management of mechanisms for the pursuit, monitored and evaluation of the risk
  • Technical Expertise in analysis of the risk of the scientific aspects
  • Exchange of information and handling of data including the participation in the BCH
  • Transference of Technology in the matter of Bio security.

Supported by UNESCO / MIRCEN network
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