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LATIN AMERICA

Andean Community

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Biodiversity Regional Strategy for Andean Tropic Countries (2002)

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Y


Y

Y

Y

Y

Y

Y


Y

Y

Selected Legal Annotations and Comments

The Andean Community is a sub-regional organization with international legal statuscomposed of five countries, namely Bolivia, Colombia, Ecuador, Peru and Venezuela and by the Andean Integration System (AIS).

The Andean Council of Foreign Ministers has adopted a Biodiversity Regional Strategy (RBS) in July 2002 (Decision 523 of July 7, 2002). The RBS contains provisions on biosafety (para. 2.7).

The RBS is the result of a broad consultative process. A series of workshops to develop the RBS was organized. The first workshop in 2001 dealt with biosafety. This workshop established a series of principles. These included: (1) the precautionary principle; (2) the Strategy to be developed in harmony with the CBD; (3) bio-ethic factors; (4) the respect for the cultural diversity, with reference to the indigenous, local and afro-american communities; (5) strengthening technology transfer which contributes to the development of safety in the use of biotechnology; (6) clear information concerning the use of LMOs for the entire population; and (7) stakeholder participation.

Labelling of genetically modified organisms is one of the issues debated during the process to develop the RBS. Labelling is addressed mainly in the context of commercialization and consumer protection. In the process some participants argued that labelling could constitute barriers to trade while others defended the right of consumers to be informed.

The development of the RBS is based on Decision 391 on “Access to Genetic Resources”, which is the legal instrument establishing the mandate for countries of the Andean Community Area (CAN) to elaborate a common regime in the field of biosafety within the CBD framework, and the Protocol on Biosafety to the CBD, which gives the legal basis for bilateral, regional and multilateral agreements (art.14.1).

The RBS contains a preliminary analysis of the situation of biodiversity in Andean Countries and a framework for the strategy. The preliminary analysis recognizes the need for a regional strategy covering biosafety arises from the lack of uniform regulatory mechanisms in the region. Security measures are to be designed to minimize the risks to environment, biological diversity, human health and the socio-economic structure when transferring, managing, using and releasing LMOs.

The analysis points out that field experimentation of LMOs has rarely been carried out in tropical ecosystems. Therefore, Andean countries need to develop institutional capabilities to perform their own research on LMOs.

Large-scale commercialization of LMOs within the CAN is identified as absent. Experience in this region appears to date to be limited to research and experimental trials. Nevertheless, it is noted that GMO releases into the environment have already taken place in countries bounding the region, such as Argentina, Brazil and Chile.

Mechanisms regulating activities in the field of biosafety have not yet been developed by the CAN countries, at least not in a uniform manner. Not all the countries have institutions tasked with receiving applications and issuing authorizations for conducting research with LMOs.

Biosafety is regulated differently in each of the CAN countries, namely though a law in Peru and Venezuela, a decree in Bolivia, two resolutions of the Colombian Agriculture and Livestock Institute in Colombia and a project of law in Ecuador. Nevertheless, the objectives of these legal provisions are similar and are linked primarily to protecting biodiversity, environment and human health. The fields of application embrace all activities involving genetically modified plants, animals and/or micro-organisms, with the exception of Colombia whose resolutions refer only to activities with LMOs in the agricultural field.

The framework for the strategy is articulated in a number of objectives, lines of action and results. Joint biosafety policies and actions are envisaged with a view to conserving and sustainably using ecosystems, species and genetic resources (objective No. 1, line of action No. 7). Such policies and actions are to result in the following mechanisms and procedures to control the trade in and the transboundary movement of LMOs: (1) a scientific basis for risk analysis; (2) labelling guidelines and (3) principles for liability and compensation for LMO-related damage (result No. 7.1).

Two other results are conceived in the section on biosafety: (1) systematising and disseminating information from LMO trials at the subregional level and (2) creating favourable conditions to enable member countries to apply the Cartagena Protocol on Biosafety (results No. 7.2 and 7.3).

The RBS does not displace or substitute for existing laws. However, the Andean Community Secretariat can develop and propose resolutions to the Andean Council of Foreign Ministers and the Andean Community Commission for approval. This will respond to the need for the Andean Community to elaborate and establish a Common Standard in the field of safety in biotechnology decisions that will support the Strategy’s implementation across the region or deal with other matters not addressed by the Cartagena Biosafety Protocol.

The CAN Secretariat, through its committees, is the institutional authority implementing the RBS. The Andean Council of Environmental Authorities (CAAN) is responsible for supervising the implementation process. To that effect, CAAN is to draw up the plan of action and the Portfolio of Projects resulting from the identified lines of action (Andean Council of Foreign Ministers, Decision 523 of July 7, 2002, art.3).

Brazil

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Law No. 8974 of 5 January 1995

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Y

Y

Y

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Y


Selected Legal Annotations and Comments

Brazil Law No. 8974 refers to clauses I and IV of the 1st paragraph of art.255 of Brazil’s Federal Constitution. It applies to the use of genetic engineering techniques in the development, cultivation, manipulation, transport, marketing, consumption, release and disposal of GMOs with the objective of protecting human, animal and plant health and the environment. Activities and projects carried out within the Brazilian territory which involves GMOs, including teaching, scientific research, technological development and industrial production, are restricted to the domain of legally established public or private organizations. These organizations are to comply with the provisions of the Law and are considered liable for any negative effect resulting from non-compliance (art.2).

Inspection agencies of the Ministries of Health, Agriculture and Environment, within their respective jurisdictions and considering the final technical opinion of the National Technical Biosafety Committee (CTNBio), are tasked with inter alia (a) controlling and inspecting all activities and projects related to GMOs; (b) issuing registrations for products containing GMOs or derived from GMOs which are to be marketed for human, animal and plant use or for release into the environment; (c) granting authorization for activities carried out by laboratories, institutions or companies; (d) granting authorizations for the entry into the country of any product containing GMOs or derived from GMOs; (e) creating a register listing all institutions carrying out in the national territory activities and projects related to GMOs; and (f) submitting to the CTNBio for its technical opinion all procedures related to projects and activities involving GMOs.

The Law clearly forbids a number of activities related to GMOs. Some of these refer to: (a) any genetic manipulation of living organisms or the in vitro handling of natural or recombinant DNA, except under the standards specified in the Law; (b) genetic manipulation of human germ cells; (c) in vivo intervention in human germ cells, except for the treatment ofgenetic defeats, complying with ethical principles and with the previous CTNBio’s approval; (d) in vivo intervention in the genetic material of animals, except for justified research purposes and with the previous CTNBio’s approval; and (e) the release or disposal into the environment of GMOs not falling under the standards set forth by CTNBio and as provided by Law (art.8).

Products containing GMOs which have originated in other countries and are to be marketed or for industry use, may only be introduced into Brazil upon CTNBio’s positive technical opinion and authorization by the pertinent control agency (art.8.1). Any organization using genetic engineering techniques and methods shall create an Internal Biosafety Commission/CIBio (art.9). A CIBio will be responsible for (a) providing information to employees and to the community on possible effects caused by activities related to GMOs, including information related to health, safety and procedures to be followed in the event of accidents; (b) establishing prevention and inspections programme; (c) maintaining progress reports for each activity or project involving GMOs; (d) notifying CTNBio, public health authorities and employees organizations of the results of risk assessment as well as any accident that may be caused by the dissemination of biological agents; and (e) investigating on the possibility of accidents and diseases possibly related to GMOs (art.10).

Liability provisions for non-compliance are contained in article 12. A number of activities, mostly related to the manipulation of human cells, are considered as crimes in article 13.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Decree No. 1752 of 20 December 1995






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Y



Y

Y

Y


Selected Legal Annotations and Comments

The Decree defines the tasks of the National Technical Biosafety Committee (CTNBio). Of particular relevance are, inter alia, the definition of the National Biosafety Policy and the power to establish regulations for activities and projects involving creating, cultivating, processing, using, transporting, commercialising and releasing of GMOs (art.2, I and V).

Part of the CTNBio’s members are designated by relevant national ministries. The membership includes, inter alia, a representative from a consumer association (art.3, II and IV).

CTNBio is to publish in the Official Journal of the Union its technical opinions together with the information provided by the applicants in order to promote dissemination of information on biotechnology-related projects, (art.2, XI).

In terms of Article 8, national, foreign or international entities, including research institutions, are required to have a certificate of quality in biosecurity as a precondition to undertaking biotechnology-related activities. The certificate is to be issued by CTNBio upon an examination procedure.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Decree No. 3.871 of 18 July 2001




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Selected Legal Annotations and Comments

The Decree applies to packaged food containing, or produced with, GMOs.

Information on the presence of GMOs should clearly appear on the package or container (art.1), with special reference to the type of product or the type of ingredient containing GMOs (art.1.1), written in Portuguese and in capital letters (art.1.2).

The Decree applies to genetically modified products which have received a positive technical opinion from the National Technical Biosafety Committee (CTNBio) in relation to the safety of commercializing such products (art.2).

An Inter-ministerial Committee is established with the objective of revising and updating the content of the Decree as well as the methods to identify the presence of GMOs in products following the scientific and technical development in this field (art.3).

The Committee will be constituted with representatives of the Ministries of Justice, Agriculture, Industry and Foreign Trade, Health and of Science and Technology designated by the Minister of Science and Technology (art.3.1).

Costa Rica

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Law 778 on Biodiversity

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Y

Y

Y

Y

Y


Y

Y

Selected Legal Annotations and Comments

The general objectives of Law 778 on Biodiversity are the conservation of biodiversity and the sustainable use of genetic resources and the equitable sharing of benefits arising out from the use of genetic resources.

The Biodiversity Law includes provisions on biosafety. These are contained in Chapter III-Environmental Safety. Biosafety mechanisms are established to avoid and prevent present and future damage to human, animal and plant health, or the integrity of ecosystems. Such mechanisms will operate for the access to elements of biodiversity for research, development, production, release or introduction of genetically modified or exotic organisms (art.44). The State has the obligation to avoid any risk or danger to ecosystems and to mitigate or restore environmental damage that has led to the deterioration of life and its quality. The Organic Environmental Law, the Civil Code, and other pertinent laws regulate the civil responsibility of anyone dealing with and considered responsible for managing GMOs that have resulted in any damage. Penal responsibility is regulated by Costa Rican law (art.45).

A permit is required from the Phytosanitary Protection Service for a number of activities involving GMOs - whether the GMO originates from the national territory or outside. A permit is required for imports, exports, research and experiments, releases into the environment and commercial uses involving GMOs. Every three months the Phytosanitary Protection Service is to send a report to the National Technical Commission of Biosafety. The Commission’s Technical Bureau maintains a register (art.46). Nationals or foreigners undertaking genetic manipulation must register with the Bureau.

On the basis of scientific, technical and safety criteria, the Technical Bureau has the power to modify or revoke any permit granted. In view of imminent danger, unexpected situations or non-compliance with official provisions, the Bureau may confiscate, destroy, or transfer GMOs or other type of organisms. It may also prohibit transfer, experimentation, release into the environment and commercialization in order to protect human health and the environment (art.48).

The Technical Bureau is to organize and update a register of rights to access to genetic and biochemical elements. The Director of the Technical Bureau also acts as Director of the Register and is responsible for the safe-keeping and authenticity of the registered information. Such information will be public except for industrial secrets which must be protected by the Register only if biosafety reasons do not oblige for public disclosure (art.67). Article 68 clarifies that as a general rule of interpretation technical, biosafety provisions, as well as application of sanitary and phytosanitary measures, cannot be interpreted as restrictions on trade. The competent administrative or juridical authorities are to void the effect of any interpretation contrary to this (art.68).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Plant Protection Law No. 7664

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Y

Y

Y

Y



Y

Selected Legal Annotations and Comments

The Plant Protection Law No. 7664 establishes a Technical Commission of Biosafety as an advisory body on biotechnology to the State Phytosanitary Service (art.40). Both article 40 and article 41 of the law are similar to articles 46 and 48 of the Biodiversity Law. According to article 40, the State Phytosanitary Service must authorize imports, exports, research and experiments, transfers, releases into the environment and commercialization of transgenic plants, genetically modified organisms or their products or other types of organisms for agricultural use, produced within or outside the national territory.

On the basis of scientific, technical and safety criteria the State Phytosanitary Service can modify or revoke any granted authorization. In view of imminent danger, unexpected situations or non-compliance with official provisions, the Service may confiscate, destroy, or forward the genetically modified organisms. Furthermore, it may prohibit the transfer, experiment, release into the environment and commercialization of genetically modified organisms in order to protect human and animal health and the environment (art.42).

Provisions for risk analysis are reflected in art.45. The State Phytosanitary Service has the responsibility to ensure that the phytosanitary measures are based on an adequate assessment of the risks to human health and the protection of plants. The Service must consider in its risk assessment: (a) scientific evidence; (b) adequate processes and production methods; (c) adequate inspection methods; (d) the presence of pests; (e) the existence of pest free areas; (f) pertinent ecological and environmental conditions; and (g) quarantine systems (art.45). In the risk assessment carried out to protect plants and to identify measures to achieve an adequate level of phytosanitary protection, the Service is to take into consideration economic factors, such as: (1) the possible damage for loss of production or sale in case of entry from the propagation of pests; (2) the cost to control or eradicate within the national territory; and (3) the cost-effectiveness of other possible methods to eliminate risks. In determining the adequate level of phytosanitary protection, the Service must consider the objective of minimizing the negative effects on commerce and not restricting trade (art.46).

Cuba

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Decree No. 190-Biological Safety (Official Gazette 1999)

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Y

Y

Y


Y


Selected Legal Annotations and Comments

Decree no.190 on Biological Safety applies to (a) the use, research, production, import and export of micro-organisms and their products and of genetically modified organisms (GMOs) and (b) the release into the environment of such organisms. It also aims to prevent the potential adverse impact of any activity related to GMOs as well as protect the environment, human health, animals and plants. It also specifically addresses the health of workers.

The Ministry of Science, Technology and Environment is the responsible Government authority that controls policy related to biological safety (art.4). Some of the Ministry’s functions include risk analysis and organizing inspections in institutions and areas where the use or release of GMOs occurs (4(a)). The Ministry has the authority to suspend and revoke authorizations for any activity related to the use, research, production and release of GMOs (art.4(c)). Furthermore, the Ministry is responsible for classifying and distributing into risk groups (a) organisms released into the environment and related possible risks for human health and the environment and (b) micro-organisms which affect human beings, animals and plants (art.4 (d)). The Ministry will establish the National System of Accounting and Control of Micro-organisms and GMOs to be released into the environment (4(f)).

Any activity related to the use of micro-organisms and their products and GMOs is to be realized in collaboration with the Ministry of Science, Technology and the Environment (art.5).

Any institution or laboratory making use of micro-organisms and GMOs has the obligation to follow all the safety requirements established by the Decree (art.6). When the release of GMOs is part of the activities of such institutions and laboratories, they must provide the Ministry of Science, Technology and Environment with all information regarding the release. The information includes recommendations related to protecting workers and the environment. The Ministry is to give its approval. Owners of areas where a release will take place are to follow a process of risks analysis and risk management (art.8).

Representatives of the State Central Administration, as well as researchers involved in this field, upon consultation with the Ministry of Science, Technology and the Environment, are responsible for developing a public information policy addressed mainly to people directly or indirectly involved with the release. The policy is to be developed in collaboration with the National Health System, political organizations and mass media (art.9).

Inspectors from the Ministry of Science, Technology and Environment are tasked with carrying out biological safety inspections (art.11). Inspections will comprise inter alia examining: (1) barriers for the contained use; (2) training programmes for staff involved in activities related to biological safety; (3) fulfilment of the appropriate practices; and (4) compliance with the rules for the use and release of micro-organisms and their product and GMOs (art.12).

Liability provisions are provided in article 15. Strict liability applies for any harm caused by toxic waste containing micro-organisms and GMOs considered dangerous to human health and the environment. In this context, owners of laboratories and areas where a release has occurred and whose activities generate toxic wastes are liable (art.15). They are required to prepare in advance their budget including possible costs for the use, transfer and disposal of such wastes (art.16).

The Ministry of Science, Technology and Environment is also responsible for elaborating, implementing and controlling national plans for possible emergency situations in case of damage caused by voluntary or accidental release of micro-organisms or GMOs (art.17). Similar plans have to be elaborated by the above-mentioned owners of laboratories and area of release (art.18).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Resolution No. 76/2000 - General Rules of Biological Safety for the Facilities where Biological Agents and their Products, Organisms and Fragments with Genetic Information are Used

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Y

Y

Y

Y




Selected Legal Annotations and Comments

Resolution No. 76/2000 regulates authorizations in the field of “safety in biodiversity”.

It establishes a classification system of authorizations of biological safety and procedures to request and grant such authorizations. It applies to anyone involved in the use, research, production, release, import and export of micro-organisms and their products and of GMOs. It also applies to the different steps of building laboratories with possible biological risks.

The authorizations have been classified as: (1) License of Biological Safety (authorizations related to activities with high potential risks for the workers, the community and the environment); (2) Permit of Biological Safety (authorizations related to activities with moderate level of risks for workers, the community and the environment); and (3) Notification (authorizations related to the activities with limited level of risk) (art.5).

Requests for authorization are to be in writing, with technical documents attached. They are to contain all the information listed in Annex 1 and Annex 2 to the Resolution. The responsible authority may request any additional information (art.10).

The responsible authority will analyse the documents submitted and undertake a risk analysis for each activity mentioned in the request with a timeframe of 90 days from the date of receipt of the documents (art.11). Within this timeframe, the responsible authority, if necessary, can organize an inspection of the facilities for which the license has been requested, to verify the safety conditions and the truthfulness of the information contained in the documents submitted (art.16).

The license, if granted, is to clearly refer to the activity which will be performed and to the person owning the laboratory. The license is temporary and it is to be renewed after its expiration (art.23). Process for renewal will follow exactly the same procedures for the first approval (art.24). If any change in the activity occurs, the license will have to be changed accordingly (art.26) and all the safety requirements will apply (art.27).

The National Centre for Biological Safety is to be responsible for controlling the process of analysis and granting of the “Permit of Safety in Biodiversity” (art.29). Requirements for the granting of permits are similar to the ones contained in art.9 and apply for the granting of licenses (art.30). Information to be contained in the technical documents is listed in Annex 3 and Annex 4 to the Resolution (art.31). Requirements for the granting, renewal and modification of permits are similar to the ones for granting of licenses (art.34).

Notification provisions are provided in art.35. Activities falling under art.8 are to be notified to the responsible authorities and will have to contain all the information listed in Annex 5 and 6 to the Resolution. The responsible authority is to control the activities notified (art.35).

In cases where an authorization is not granted, the applicant can bring a claim within 30 days from the date of receipt of the communication refusing the authorization (art.36). A Special Process of Revision is possible within 180 days from the date of refusal.

Mexico

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Official Mexican Standard NOM-056-FITO-1995 to Establish the Phytosanitary Requirements for Interstate Movement, Importation and Conduct of Field Trials with regard to Organisms Manipulated by the Application of Genetic Engineering

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Y

Y

Y

Y

Y

Y

Y



Selected Legal Annotations and Comments

The Mexican Standard governs movement within the national territory, import, release into the environment and experimental trials of GMOs for agricultural uses. It applies to any public or private institution, or any individual, who in any way participates in the movement, release into the environment, or evaluation of transgenic products

Transgenic products that will be released into the environment and/or imported require a plant certificate. The General Directorate for Plant Health must be notified of any interstate movement (sect. 3.1). Anyone wishing to obtain a certificate for environmental release must submit an application, in the appropriate format (Annex 1), to the General Directorate for Plant Health. The General Directorate shall respond within 120 calendar days, provided that the information contained in the application is complete. If this is not the case, the party concerned will be asked to provide the missing information. The 120-day period commences from the date the application is considered complete (sect. 3.2.1).

The General Directorate for Plant Health is the responsible authority for issuing certificates for the genetically manipulated products that will be released into the environment (Annex 3). Certificates can only be issued upon favourable opinion from the National Agricultural Biosafety Committee. The General Directorate must submit the application to the Committee for review. A copy of the application and of the Committee’s opinion is to be sent to the relevant governmental office and to the pertinent governmental authority of the country in which the release will take place. The governmental office and/or the government of the country has a maximum of 30 calendar days to send comments to the head of the General Directorate for Plant Health (sect. 3.2.2). All the information to be provided by the applicant is contained in Annex 1.

If the product has been moved and/or imported prior to the submission of the application for release into the environment, a copy of the relevant import and/or movement certificate must be attached to the application (sect. 3.2.4). The applicant shall prepare a letter in which he assumes responsibility for the handling or destruction of the product once the field trials are over, in such a way as to prevent its escape into the environment. Similarly he will have to prepare a letter saying that the handling or destruction of the product has been carried out (sect. 3.2.5). The transgenic product released, moved and/or imported must be kept in the areas and premises mentioned in the application (sect. 3.2.6).

Labelling provisions are provided in sections 3.2.7 and 3.5. A transgenic product released, moved and/or imported must be identified and labelled as such. Labels must be visible on the container or package and have, inter alia, information on: (1) the general nature and quantity of the contents; (2) the country and/or place where the product was collected, developed, manufactured, cultivated or reproduced; (3) the name and address of the carrier and of the sender and (4) the number of the plant health certificate for release and/or import.

The person authorized by the Secretariat of Agriculture, Livestock and Rural Development to inspect and monitor the transgenic product released must keep the Secretariat periodically updated (sect.3.2.8). The General Directorate must always be notified within 24 hours when an accidental release of transgenic products takes place. It must be also notified when the manipulated product or the associated host organism differs substantially from the characteristics mentioned in the application, or it shows signs of disease or there are indications of mortality or any unforeseen effect on organisms which are not intended (notification within 5 working days) (sect.3.2.10).

The personnel authorized by the Secretariat may, at any time, inspect the area where the manipulated products are to be released. The costs incurred in the inspection procedures shall be borne by the applicant (sect.3.2.11).

The General Directorate for Plant and Animal Health Inspection at Ports, Airports and Border Crossing issues a plant health import certificate for transgenic products (sect.3.3) upon submission of detailed documents to the Customs Office. The General Directorate for Plant Health is responsible for issuing the plant health requirements and biosafety measures for the importation of transgenic products. The application is processed in the same way as an application for release into the environment (sect.3.3.2).

The party concerned with the interstate movement of a transgenic product must notify the General Directorate for Plant Health, which is responsible for authorizing such movement. The application should be attached to the notification. The General Directorate shall officially inform the party concerned whether the movement may be made within the same deadline and according to the same procedures identified for the import (sect.3.3.4).

An application for import must be sent to the Directorate General for Plant Health in the appropriate format. The Directorate General is to respond within 75 calendar days, provided that application is complete. If this is not the case, the party concerned is asked to provide the missing information. The 75-day period begins when the application contains all the necessary information. If the missing information is not provided, the application shall be cancelled (sect.3.3.4).

Section 3.3.5 deals with handling provisions. The packing material, containers and any other material accompanying the transgenic product when it is imported or moved, must be handled in such a way as to prevent the dissemination of the product itself. The individual or legal entity to whom the certificate for the importation of the transgenic product has been issued must inform the General Directorate for Plant Health of the date of arrival at its final destination or if, for any reason, it did not arrive (sect.3.3.6). The transgenic products must comply with the plant health import requirements established by the official Mexican Standards on plant quarantine, depending on the agricultural product (fruit, vegetables, seeds, propagating material and cut flowers) to be imported (sect.3.3.7). The certificate issued is valid only for release in the field and/or import and/or movement for research or reproduction of material purposes. Commercialization of transgenic products within the national territory is not included.

The General Directorate may cancel a certificate for environmental release in the event of failure to comply with one or more of the conditions indicated on the certificate. It must give explanatory information on the cancellation within 10 days (sect.3.4).

Non-compliance with the provisions of the standard results in sanctions pursuant to the provisions of the Federal Plant Health and the Federal Law on Metrology and Standardization (sect.5).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Law on Sustainable Rural Development

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Y

Y

Y

Y

Y

Y

Y


Selected Legal Annotations and Comments

The Law on Sustainable Rural Development is to promote sustainable rural development in Mexico. It addresses the planning and organization of agricultural production of goods and services and of actions aimed at improving the rural population’s welfare. Article 91 addresses plant and animal health and GMOs. It sets out the objective of reducing the risks associated with production and public health as well as facilitating national and international commercialization of GMO-products. For those purposes import, transfer and handling of GMOs are to be regulated. Quarantine actions and programmes are also referred to.

The Federal Government is to establish a National System of Health and Food and Agricultural Quality. The Secretariat of Agriculture, Livestock, Rural Development, Fishery and Food will coordinate the activities of the National System (art.92). An Inter-secretariat Commission, with the participation of the Mexican Council, will propose to the Secretariat of External Relations, the adhesion to treaties and international instruments considered necessary in the field of GMOs. It may also promote agreements to harmonize phytosanitary requirements (art.95). The Federal Government is to establish mechanisms and instruments for biosafety related to the production, import, handling, propagation, release, consumption, use and general development of GMOs, their products and sub-products. Consumers are to be provided with sufficient information (art.97).

Article 97 also deals with the precautionary principle: a GMO is presumed to present risks or adverse effects when scientific evidence does not demonstrate the contrary.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

The General Law on Health

Y








Y

Y




Selected Legal Annotations and Comments

TheGeneral Law on Healthregulates the protection of human health. It provides the regulatory framework for food safety. It includes a chapter on biotechnology products (Chapter XXII bis). The Secretariat of Health is to be notified of any biotechnology products for human use (art.282 bis 1). Any requirements related to the labelling of such products are to be included in the pertinent official Mexican standard (art.282 bis 2).

The Secretariat of Health is the responsible authority for the health control of products listed in Chapter XII, including biotechnology products, and for identifying the characteristics of such products (art.283). The Secretariat of Health can verify, certify and control the quality of products subject to import. Where these products do not correspond to the characteristics established by the pertinent legislation, the Secretariat will apply all the correspondent safety requirements (art.284).

Products which are new or introduced for the first time in Mexico, are to be analysed in special laboratories in order to verify their compliance with the official Mexican standards (art.286 bis, para.III).

Peru

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Law No. 27104 on the Prevention of Risks Derived from Biotechnology (“Diario Oficial-El Peruano” 12 May 1999)

Y





Y

Y

Y

Y

Y

Y

Y

Y

Selected Legal Annotations and Comments

Law No. 27104 regulates safety in biotechnology in harmony with the Peruvian Constitution and articles 8 (g) and 19 (3) and (4) of the Convention on Biological Diversity. The law aims: (1) to protect human health, the environment and biological diversity; (2) to promote safety in the research and development of biotechnology and its applications; (3) to regulate, manage and control the risks derived from the contained use and release; and (4) to regulate the movement and commercialization of LMOs, within the country and between other countries, in order to facilitate international technology transfer in harmony with international legal instruments signed or to be signed in the future by the government (art.2).

The general rules established by the law apply to the activities of research, production, manipulation, transfer, conservation, commercialization, contained use and release of LMOs (art.3). The law does not apply to activities involving human genes, organisms genetically modified through conventional techniques, any kind of vaccine for human beings or natural processes (art.4).

A National Environment National Council (CONAM) is established. It functions as the competent authority to coordinate matters involving conservation and sustainable exploitation of biodiversity. CONAM promotes, through the Peruvian Environmental Management Framework, coordination between the various authorities involved in the safety of biotechnology (art.5.1). The National Commission on Biological Diversity (CONADIB) is the advisory body for matters on safety in biotechnology and supports CONAM in proposing guidelines on LMOs to be approved in harmony with the Law (art.5.2). An information exchange mechanism at the national and international level is to be established among competent institutions and agencies (art.8).

The precautionary principle is reflected in article 10. The negative impacts to human health, the environment and biodiversity, which may be caused by the release of LMOs, are to be analysed. The State can refuse to authorize the use and release of LMOs where there is a threat of serious damage, but only if such denial is technically justified and does not constitute a technical barrier to or restriction on trade. Requests to transfer LMOs whose use has not been authorized in other countries will be denied and the use of LMOs will be prohibited within the national territory. The same rule applies to LMOs not tested in any other country and whose use may eventually constitute a risk (art.11). In this context, pertinent information will be given to the National Customs Authorities for pertinent actions. The use of LMOs in biological weapons is strictly prohibited. Criteria are provided for risk assessments to be undertaken according to the prior informed consent procedure and carried out on a case-by-case basis (art.13). Risk management is to be carried out following scientific and technical criteria which will have to be periodically evaluated and updated (art.14).

Anyone wanting to introduce LMOs into the national territory for any of the activities listed under article 3 is to present a formal application to the competent authority (art.16). In the case of an importer with foreign nationality, the application is to be countersigned by the competent authority of the importer’s country (art.17).

The application is to include all the information necessary for carrying out a risk assessment (art.18). When the application is received, an informative summary is published at the national level. The information contained in the application is subject to confidentiality restrictions to avoid its unfair use in cases where the applicant brings a claim for confidentiality to the competent organ. The informative summary will be published accordingly (art.24). Information that cannot be kept confidential includes: (1) the name of the applicant; (2) the objectives of the activities to be realized, where these will be realized; and (3) methods and plans for monitoring and emergency plans, risk assessment (art.24). Confidentiality restrictions cannot be authorized when the application concerns activities which may cause damage to human health, the environment and biodiversity (art.25).

The Law’s final provisions refer to the National Programme of Genetic Resources and Biotechnology (PRONARGEB) and to the National Institute of Agricultural Research (INIA). PRONARGEB and INIA provide technical advice concerning activities with transgenic LMOs. When LMO-related activities are proposed for the Amazon, the Research Institute of Peruvian Amazon (IIAP) is to provide technical advices.

A certificate of plant or animal health cannot be granted by the National Service of Agricultural Health (SENASA) without the importer of plant or animal LMOs first providing SENASA with the administrative resolution authorizing import of LMO in the territory.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Decree No. 102-2001-PCM “National Strategy on Biological Diversity”

Y

Y





Y

Y

Y

Y


Y

Y

Selected Legal Annotations and Comments

Decree No. 102-2001 supports the implementation in Peru of Article 6 of the Convention on Biological Diversity (national biodiversity strategies and action plans). The decree is divided into chapters, each containing strategic objectives and actions to be taken.

Chapter 2 “Integration of the Sustainable Use of Biological Diversity” contains eleven strategic objectives. Point 2.9 refers explicitly to biosafety. It recognizes the need to establish regulatory mechanisms for the manipulation of genetic resources, promoting biotechnology as an important tool to develop and control LMOs. Four actions are identified.

A National Programme for Biosafety will be established in accordance with the Cartagena Biosafety Protocol. This is addressed in action point 2.9.1. It will consider the benefits and risks derived from activities with LMOs and their products. Food and agriculture aspects will be emphasized.

The establishment of a National Biosafety System is envisaged to promote research on native species and establish protection criteria and safety indicators, in order to raise the value of traditional knowledge in the use of biodiversity (action point 2.9.2). Biotechnology will contribute to determine the economic value of native genetic resources. The development of research and training programmes to minimize the impacts on human health, the environment and biodiversity is also contemplated.

Action point 2.9.3 addresses the implementation of the Law on the Prevention of Risks Derived from the Use of Biotechnology. Economic and technical-scientific support to the institutions involved in controlling the potential risks of biotechnology is to be provided.

Finally action point 2.9.4 supports the implementation of the law by calling for improved mechanisms of control and prevention along with risk analysis, and by developing national and regional capacity building to identify and anticipate the transfer of LMOs into the national territory.

A National Biological Diversity Information System is identified as strategic objective 6.5. The system is to be updated with inputs from a series of networks in key areas such as biotechnology, genetic resources, germplasm banks, inventories of terrestrial and aquatic ecosystems. Integrating information on the various components of Peruvian biodiversity will play an important role in the information system’s establishment, especially when results of scientific research and the scientific knowledge of communities are included.


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