Law On Biosafety Of Genetically Modified Organisms

Original Language Title: Ley de Bioseguridad de Organismos Gen├ęticamente Modificados

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DECREE issuing the Law on the Biosafety of Genetically Modified Organisms

HEALTH SECRETARY

Genetically Modified Organisms ' Biosafety Law.

On the sidelines a seal with the National Shield, which reads: United Mexican States.-Presidency of the Republic.

VICENTE FOX QUESADA, President of the United Mexican States, to its inhabitants known:

That the Honorable Congress of the Union, has served to address the following

DECREE

THE CONGRESS OF THE MEXICAN UNITED STATES, DECREES:

THE BIOSAFETY LAW OF GENETICALLY MODIFIED ORGANISMS IS TO BE ESTABLISHED.

UNICO ARTICLE: The Biosafety of Genetically Modified Organisms Law is issued to remain as follows:

BIOSAFETY LAW OF GENETICALLY MODIFIED ORGANISMS

TITLE FIRST General Provisions

CHAPTER I Object and Finalities

ARTICLE 1.- This Law is of public order and of social interest, and is intended to regulate activities of contained use, experimental release, release in pilot program, release trade, marketing, import and export of genetically modified organisms, in order to prevent, prevent or reduce the possible risks that these activities could cause to human health or the environment and to biological diversity or animal, plant and aquaculture health.

ARTICLE 2.- To fulfill its object, this order is for purposes:

I. Ensuring an adequate and efficient level of protection of human health, the environment and biological and animal health, plant and aquaculture, with respect to adverse effects may cause them to carry out activities with genetically modified organisms;

II. Define national principles and policy on the biosafety of GMOs and instruments for their implementation;

III. Determine the competencies of the various dependencies of the Federal Public Administration on the biosafety of the OGMs;

IV. Establish the basis for the conclusion of agreements or coordination agreements between the Federation, through the competent Secretariats and the governments of the federal entities, for the best fulfillment of the purpose of this Law;

V. Establish the basis for the operation of the Biosafety Intersecretarial Commission of Genetically Modified Organisms, through which the Secretariats that integrate them must collaborate in a coordinated manner, in the field of their competences, with regard to the biosecurity of genetically modified organisms;

VI. Establish administrative procedures and criteria for the assessment and monitoring of possible risks that may result from activities with genetically modified organisms in health human or environmental and biological diversity or animal, plant or aquaculture health;

VII. Establish the permit regime for the conduct of experimental release, pilot release and commercial release activities, of genetically modified organisms, including the importation of such organisms to carry out such activities;

VIII. Establish the warning regime for the conduct of contained use activities of genetically modified organisms, in the cases referred to in this Law;

IX. Establish the regime of the Health Secretariat authorizations of genetically modified organisms that are determined in this Law;

X. Create and develop the National Biosafety Information System and the National Biosafety Register of Genetically Modified Organisms;

XI. Determine the basis for the case-by-case establishment of OGMs-free geographic areas in which it is prohibited and those in which activities are restricted with certain genetically modified organisms, as well as crops from which Mexico is a source of origin, in particular maize, which will maintain a special protection regime;

XII. Set the basis for the content of Mexican official standards on biosecurity;

XIII. Establish control measures to ensure biosecurity, as well as corresponding penalties in cases of non-compliance or violation of the provisions of this Law, its regulations and Mexican official rules deriving from it;

XIV. Establishing mechanisms for public participation in the biosafety aspects of this Law, including access to information, participation of the private, social and productive sectors through the CIBIOGEM Joint Consultative Council, and the public consultation on requests for the release of GMOs into the environment, and

XV. Establish instruments to promote scientific and technological research in biosafety and biotechnology.

ARTICLE 3.- For the purposes of this Act, it is understood by:

I. Accidents: The inadvertent release of genetically modified organisms during their use and which may, on the basis of technical criteria, pose possible risks to human health or for the environment and biological diversity.

II. Activities: Confined utilization, experimental release, pilot release, commercial release, marketing, import, and export of organisms genetically modified according to this Law.

III. Authorization: It is the administrative act by which the Health Secretariat, in the field of its jurisdiction under this Law, authorizes certain genetically modified organisms expressly in this order, in order to enable them to be placed on the market and import for marketing, as well as their use for public health or bioremediation purposes.

IV. Bioremediation: The process in which genetically modified microorganisms are used for the degradation or disintegration of pollutants that affect resources and/or natural elements, effect of turning them into simpler and less harmful or environmentally damaging components.

V. Biosafety: The actions and measures of evaluation, monitoring, control and prevention that must be undertaken in the performance of activities with genetically modified organisms, with the object of to prevent, prevent or reduce the potential risks to human health or the environment and biological diversity of such activities, including the safety aspects of such organisms intended for use or consumption human.

VI. Modern Biotechnology: The application of nucleic acid in vitro techniques, including recombinant deoxyribonucleic acid (DNA and RNA) and direct injection of nucleic acid in cells or organelles, or the fusion of cells beyond the taxonomic family, which exceeds the natural physiological barriers of reproduction or recombination and which are not techniques used in reproduction and selection traditional, which are applied to give origin to genetically modified organisms, to be determined in the Mexican official rules deriving from this Law.

VII. Case by case: The individual evaluation of the genetically modified organisms, supported by the available scientific and technical evidence, considering, among other aspects, the organism receptor, the area of release and the characteristics of the genetic modification, as well as the background that exists on the performance of activities with the organism in question and the benefits compared with alternative technological options to deal with the specific problem.

VIII. Source Center: This is the geographic area of the national territory where the domestication of a particular species was performed.

IX. Center for Genetic Diversity: It is that geographical area of the national territory where there is a morphological, genetic or both species of species, characterized by populations of wild relatives and which constitutes a genetic reserve.

X. Marketing: It is the introduction to the market for the distribution and consumption of genetically modified organisms in the quality of products or goods, without intentional release purposes the environment and regardless of the profit motive and the legal title under which it is carried out.

XI. CIBIOGEM: The Biosafety Intersecretarial Commission of Genetically Modified Organisms.

XII. CONACyT: The National Science and Technology Council.

XIII. Biological Diversity: The variability of living organisms from any source, including, among other things, terrestrial and marine ecosystems and other aquatic ecosystems and complexes The ecological aspects of those that are part of it, including the diversity within each species, between species and ecosystems.

XIV. Safety: The health assessment of genetically modified organisms for use or human consumption or for processing of food for human consumption, the purpose of which is ensure that such bodies do not cause risks or damage to the health of the population.

XV. Release: The introduction into the environment of an organism or combination of genetically modified organisms, without any containment measures being taken, such as barriers physical or a combination of these with chemical or biological barriers, to limit their contact with the population and the environment.

XVI. Commercial Release: It is the introduction, intentional and permitted in the environment, of an organism or combination of genetically modified organisms, without having been adopted containment measures, such as physical barriers or a combination of these with chemical or biological barriers, to limit their contact with the population and the environment, which is carried out for commercial, production, bioremediation, industrial and any other other than experimental and/or experimental release release in pilot program, in terms and conditions containing the respective permission.

XVII. Experimental release: It is the introduction, intentional and permitted in the environment, of a organism or combination of genetically modified organisms, provided they have been adopted containment measures, such as physical barriers or a combination of these with chemical or biological barriers, to limit their contact with the population and the environment, exclusively for experimental purposes, in terms and conditions that contain the respective permission.

XVIII. Release in pilot program: It is the introduction, intentional and permitted in the environment, of an organism or combination of genetically modified organisms, with or without containment, such as physical barriers or a combination of these with chemical or biological barriers, to limit their contact with the population and the environment, which constitutes the stage prior to the commercial release of the said organism, the approved zones and in the terms and conditions contained in the respective permission.

XIX. Environment: The set of natural and manmade or man-made elements that make possible the existence and development of human beings and other living organisms that interact in a given space and time, outside the area of facilities or the scope of the contained use of genetically modified organisms.

XX. Body: Any living biological entity capable of reproducing or transferring or replicating genetic material, the sterile organisms being included in this concept. micro-organisms, viruses and viroids, whether or not they are cellular. Human beings should not be considered organisms for the purposes of this Law.

XXI. Genetically modified organism: Any living organism, with the exception of humans, that has acquired a novel genetic combination, generated through the specific use of modern biotechnology techniques that is defined in this Law, provided that techniques are used to be established in this Law or in the Mexican official rules that derive from it.

XXII. GMOs or GMOs: Organism or genetically modified organisms.

XXIII. Step by step: A methodological approach under which all GMOs that are destined to be commercially released must be pre-tested in accordance with the risk assessment, risk assessment and the reporting of results applicable in the conduct of experimental release and pilot release activities of such organisms, in the terms of this Law.

XXIV. Permission: It is the administrative act that it is up to you to issue to the SEMARNAT or to the SAGARPA, in the field of their respective competences according to this Law, necessary for the realization of the experimental release, the release in pilot program, the commercial release and the importation of GMOs to carry out such activities, in the cases and terms established in this Law and in the Mexican official norms that result from it.

XXV. Products containing genetically modified organisms: They are those that contain some or some genetically modified organisms in their composition for marketing.

XXVI. Derivative Products: These are those in which genetically modified organisms have been involved as inputs in their production process, including their extracts, provided they do not contain genetically modified organisms in their composition for the placing on the market and therefore do not have the capacity to transfer or replicate their genetic material.

XXVII. Registration: The National Biosafety Register of Genetically Modified Organisms.

XXVIII. Waste: Any waste material generated in the contained use of genetically modified organisms, including the genetically modified organisms themselves.

XXIX. Secretariats: The Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food, the Secretariat of the Environment and Natural Resources and the Secretariat of Health, regarding their respective areas of competence set out in this Act.

XXX. SAGARPA: The Agriculture, Livestock, Rural Development, Fisheries, and Food Secretariat.

XXXI. SEMARNAT: The Environment and Natural Resources Secretariat.

XXXII. SHCP: The Finance and Public Credit Secretariat.

XXXIII. SSA: The Health Secretariat.

XXXIV. Confined Use: Any activity that modifies the genetic material of an organism or by which it is, thus modified, cultured, stored, employed, processed, transported, trade, destroy or eliminate, provided that physical barriers or a combination of these with chemical or biological barriers are used in the performance of such activities, in order to effectively limit their contact with the population and with the environment. For the purposes of this Act the area of facilities or the scope of the contained use is not part of the environment.

XXXV. Authorized zones: The geographic areas or regions to be determined on a case-by-case basis in the resolution of a permit, in which the environment can be released to the environment modified to be analyzed.

XXXVI. Restricted Zones: Source centers, genetic diversity centers, and protected natural areas, within which activities with organisms are restricted genetically modified, in the terms of this Law.

ARTICLE 4.- It is the subject of this Law that the biosafety of all GMOs obtained or produced through the application of the techniques of modern biotechnology referred to in this order, used for agricultural, livestock, aquaculture, forestry, industrial, commercial, bioremediation and any other purposes, with the exceptions provided for in this Law.

ARTICLE 5.- It is also the subject of this Law to authorize GMOs to be used for human consumption or processing for human consumption, in order to be marketed. and import for marketing. It is also the subject of this order that the authorisation of GMOs, other than the previous ones, is used for a public health purpose or for bioremediation.

ARTICLE 6.- They are excluded from the scope of this Act:

I. The activities of the contained use, experimental release, release in pilot program and commercial release, marketing, import and export of GMOs, when the modification The genetic engineering of these organisms is obtained by techniques of traditional mutagenesis or cell fusion, including the protoplast of plant cells, in which the resulting organisms can also be produced by traditional methods of multiplication or culture in vivo or in vitro, provided that these techniques do not involve the use of genetically modified organisms as receiving or parental organisms;

II. The use of in vitrofertilization techniques, conjugation, transduction, transformation or any other natural process and polyploid induction, provided that no molecules are used. Recombinant deoxyribonucleic acid (DNA) or genetically modified organisms;

III. The production and processing of drugs and drugs with GMOs generated from confined processes whose regulation corresponds to the General Health Law;

IV. The sanitary control of the derived products and the confined production processes in which GMOs are authorized under this Law, for human or animal use or consumption, which remain subject to the provisions of the General Health Law and its regulations applicable to all products and processes;

V. The human genome, human stem cell culture, human germ cell modification, and hospital biosecurity, which are regulated by the General Health Law, and to the International Treaties in which the United Mexican States are a party;

VI. The collection and use of biological resources, whose regulation corresponds to the General Law of Ecological Balance and Environmental Protection, to the General Law of Wildlife, and to the International treaties in which the United Mexican States are a party, and

VII. The intellectual property of biotechnological products and processes, which is the subject of the Industrial Property Law, the Federal Law on Plant Varieties and International Treaties in that the United Mexican States are a party.

ARTICLE 7.- The activities, organisms and products subject to the scope of this Law, will not require, in matters of biosecurity and safety, other permits, authorizations, notices and, in general, requirements, formalities and restrictions that are laid down in this order.

Except as provided in the preceding paragraph:

I. The measures that in general health care should be taken by the Health Secretariat in the terms of the General Health Law and its regulations, except as regards processing and issuing of authorisations regulating this Act;

II. The measures to be taken in the field of animal, plant and aquaculture health to the Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food, in the terms of the Federal Law of Animal Health, of the Federal Law on Plant Health, of the Law of Fisheries, of the Law of Sustainable Rural Development, and of the other applicable provisions, and

III. The environmental measures to be adopted by the Secretariat of the Environment and Natural Resources in the terms of the General Law of Ecological Balance and Protection of the Environment, of the General Law of Wildlife, of the General Law of Sustainable Forest Development and other applicable laws in this field, except as regards:

A) Assessment of the environmental impact and risk study covered in Section V of Chapter IV of Title First and Chapter V of Title IV of the General Law of Ecological Balance and Protection of the Environment, and

B) The processing and issuance of permits and the other control and monitoring instruments that this Law regulates.

ARTICLE 8.- In the absence of express provision in this order, it will be established in the Federal Law of Administrative Procedure.

CHAPTER II Principles on Biosafety

ARTICLE 9.- For the formulation and conduct of the biosafety policy and the issuing of the regulations and the Mexican official rules deriving from this Law, the following shall be observed: principles:

I. The Mexican Nation has a biodiversity of the most extensive in the world, and in its territory are areas that are center of origin and genetic diversity of species and varieties that must be protected, used, promoted and sustainably exploited, as a valuable reservoir of wealth in molecules and genes for the sustainable development of the country;

II. The State has an obligation to guarantee the right of every person to live in an environment suitable for food, health, development and welfare;

III. The biosafety of GMOs is aimed at ensuring an adequate level of protection in the sphere of confined use, experimental release, pilot release, commercial release, the placing on the market, import and export of such organisms resulting from modern biotechnology which may have adverse effects on the conservation and sustainable use of the environment and diversity biological, as well as human health and animal health, plant and aquaculture;

IV. In order to protect the environment and biological diversity, the Mexican State should apply the precautionary approach according to its capabilities, taking into account established commitments. in treaties and international agreements of which the United Mexican States are a party. Where there is a danger of serious or irreversible damage, the lack of absolute scientific certainty should not be used as a reason for delaying the adoption of effective measures on the basis of costs to prevent environmental and environmental degradation. biological diversity. Those measures shall be adopted in accordance with the provisions and administrative procedures laid down in this

;

V. The protection of human health, the environment and biological diversity require attention to be paid to the control and management of the possible risks arising from activities with OGMs, through a prior assessment of such risks and post-release monitoring;

VI. The knowledge, opinions and experience of scientists, particularly those in the country, is a valuable element of guidance for the regulation and administration of the activities with GMOs are based on scientifically based studies and opinions, and therefore scientific research and technological development in biosafety and biotechnology should be encouraged;

VII. In the contained use of GMOs for the purposes of teaching, scientific and technological, industrial and commercial research, the provisions of this Law, its regulations and the official Mexican rules resulting from it, as well as the rules and principles of prevention established by the institutions themselves, centres or undertakings, whether public or private, which carry out such activities;

VIII. The potential risks that activities with OGMs may produce to human health and biological diversity will be assessed on a case-by-case basis. Such assessment shall be supported by the best available scientific and technical evidence;

IX. The release of GMOs into the environment must be done step by step according to which, any GMO that is destined to be commercially released must be previously submitted to satisfactory tests. in accordance with risk studies, risk assessment and reporting of results applicable to the conduct of experimental release and pilot-release activities of such organisms, in the terms of this Law;

X. The adverse effects that the release of GMOs could cause to biological diversity should be monitored, taking into account the potential risks to human health;

XI. The administrative procedures for granting permits and authorizations to perform activities with GMOs must be effective and transparent; in the issuing of regulations and standards Mexican officials resulting from this Law, must observe the commitments established in international treaties and agreements in which the United Mexican States are a party, so that their content and scope are compatible with those agreements. treaties and agreements;

XII. It is necessary to support technological development and scientific research on genetically modified organisms that can contribute to the needs of the Nation;

XIII. For the analysis of solutions to particular problems, the benefits and the possible risks of the use of GMOs will be assessed on a case-by-case basis. This analysis may also include the assessment of the risks of alternative technological options to deal with the specific problem for which the GMO was designed. Such comparative analysis shall be based on scientific and technical evidence, as well as background on use, production and consumption, and may be an additional element in the risk assessment study to decide, in a case-by-case basis, on the release to the environment of the GMO concerned;

XIV. The appropriate capacity and regulations to prevent accidental release to the environment of OGMs from waste of any type of process in which they have been used by those bodies;

XV. The application of this Law, the administrative procedures and criteria for the assessment of the possible risks that could generate the activities that this Law regulates, the instruments of control of these activities, the monitoring of these activities, their regulations and the Mexican official rules that result from them, the inspection and surveillance procedures to verify and verify compliance with this Law and the provisions of the The European Commission, which has been a Member of the European Commission, has been in the process of Application of sanctions for violations of the precepts of this Law and the provisions that emanate from it, are the way in which the Mexican State acts with caution, in a prudent manner and with scientific and technical bases to prevent, reduce or prevent the potential risks that activities with GMOs could cause to human health or to the environment and biological diversity;

XVI. The biosafety of agricultural, fishery and aquaculture products is closely related to plant, animal and aquaculture health, so the policy in these areas must be understand the environmental, biological diversity, human health and plant and animal health aspects;

XVII. The Mexican State will cooperate in the sphere of information and research exchange on the socio-economic effects of GMOs, especially in indigenous and local communities;

XVIII. The Mexican State shall ensure public access to the information on biosafety and biotechnology referred to in this Law, in accordance with the provisions of this Law and the provisions applicable to the matter of access to government public information, and

XIX. Experiments with GMOs or any other organism for the purpose of manufacturing and/or the use of biological weapons are prohibited in the national territory.

CHAPTER III Biosecurity

ARTICLE 10.- They are competent authorities in the field of biosecurity:

I. SEMARNAT;

II. The SAGARPA, and

III. The SSA.

The SHCP shall have the powers provided for in this Law, as regards the importation of GMOs and products containing them.

ARTICLE 11.- It is for SEMARNAT to exercise the following powers with respect to activities with all types of GMOs, except in the case of GMOs that correspond to SAGARPA:

I. Participate in the formulation and apply the general biosecurity policy;

II. Analyze and assess on a case-by-case basis the possible risks that activities with GMOs could cause to the environment and biological diversity, based on risk studies and reports of results to be developed and submitted by stakeholders in the terms of this Law;

III. Resolving and issuing permits for the realization of release activities to the environment of GMOs, as well as establishing and monitoring the conditions and measures to be subject to such conditions activities, in accordance with the provisions of this order, including the release of GMOs for bioremediation;

IV. To monitor the effects that the release of GMOs, permitted or accidental, to the environment and biological diversity could cause, in accordance with the provisions of this Law and the Mexican official rules that result from it;

V. Participate in the elaboration and issuance of the lists referred to in this Law;

VI. To suspend the effects of permits, when it has scientific and technical information to be deduced that the permitted activity poses risks higher than expected, which may affect negatively to the environment, to biological diversity or to human health or animal, plant or aquaculture health. These last two cases, at the express request of the SAGARPA or the SSA, according to their competence under this Law, with support in technical and scientific elements;

VII. Order and apply relevant security or enforcement measures, with scientific and technical basis and in the precautionary approach, in the terms of this Act;

VIII. Inspect and monitor compliance with this Law, its regulations, and the Mexican official rules resulting therefrom;

IX. Impose administrative sanctions on persons who violate the provisions of this Law, their regulations and the Mexican official rules that result from it, without prejudice, where appropriate, to penalties which correspond to the fact that the acts or omissions constituting infringements of this order are also a constituent of crime, and of the civil and environmental liability that may result, and

X. The others that this Act confers on you.

ARTICLE 12.- It is for the SAGARPA to exercise the powers conferred on it by this Law, in the case of activities with GMOs in the following cases:

I. Plants that are considered agricultural species, including seeds, and any other organism or product within the scope of the Federal Plant Health Law, with the exception of of the wild and forest species regulated by the General Wildlife Law and the General Law of Sustainable Forest Development, respectively, and those under some protection regime by Mexican official standards derived from those laws;

II. Animals considered to be livestock species and any other considered within the scope of the Federal Animal Health Act, with the exception of wild species regulated by the General Wildlife Law and those under some protection regime for Mexican official standards derived from these laws;

III. Plant-animal and animal nutrition and plant nutrition;

IV. Fishing and aquaculture species, with the exception of those under some protection regime by official Mexican standards;

V. GMOs that are used in immunization to protect and prevent the spread of animal diseases;

VI. GMOs that are fungi, bacteria, protozoa, viruses, viroids, spiroplasmas, phytoplasmas, and other microorganisms, which have agricultural, livestock, aquaculture or plant-animal production purposes, and

VII. In other organisms and products that are determined by the regulation of this Act.

ARTICLE 13.- In the cases established in the previous article, it is for the SAGARPA to exercise the following privileges:

I. Participate in the formulation and apply the general biosecurity policy;

II. Analyze and assess on a case-by-case basis the possible risks that activities with GMOs could cause to animal, plant and aquaculture health, as well as to the environment and biological diversity, with basis in the risk studies and the reporting of results to be developed and submitted by stakeholders in the terms of this Law;

III. Resolving and issuing permits for the conduct of activities with GMOs, as well as establishing and monitoring the conditions and measures to be subject to such activities, as per the provisions of this order;

IV. Perform monitoring of effects that may cause the release of GMOs, permitted or accidental, to animal, plant and aquaculture, and biological diversity, in accordance with what This Law and the Mexican official rules that derive from it are available;

V. Participate in the elaboration and issuance of the lists referred to in this Law;

VI. To suspend the effects of permits, when it has scientific and technical information that is supervenient from which it is deduced that the permitted activity poses risks superior to those intended, may adversely affect animal, plant or aquaculture health, biological diversity or human health. These last two cases, at the express request of the SEMARNAT or the SSA, according to their competence according to this Law, with support in technical and scientific elements;

VII. Order and apply relevant security or enforcement measures, with technical and scientific basis and in the precautionary approach, in the terms of this Act;

VIII. Inspect and monitor compliance with this Law, its regulations, and the Mexican official rules resulting therefrom;

IX. Impose administrative sanctions on persons who violate the provisions of this Law, their regulations and the Mexican official rules that result from it, without prejudice, where appropriate, to penalties which correspond to the fact that the acts or omissions constituting infringements of this order are also constitutive of crime, and of the civil liability that may result, and

X. The others that this Act confers on you.

ARTICLE 14.- In cases where SEMARNAT is responsible for the knowledge, processing and resolution of a permit application, in the case of wild and forest species, it must submit the the relevant file to the SAGARPA for the relevant opinion to be issued.

ARTICLE 15.- In cases that fall within the jurisdiction of the SAGARPA, the SEMARNAT will have the following:

I. Issue the appropriate biosecurity opinion prior to the resolution of the SAGARPA, as a result of the analysis and risk assessment carried out on the basis of the study to be developed and presented the interested parties, on the possible risks that the activity with GMOs in question may cause to the environment and to biological diversity, in the case of applications for permits for the experimental release of these organisms, or on the basis of the results reports and the information that the data subjects attach to their permit applications for release in pilot program and for commercial release;

II. Require the SAGARPA to suspend the effects of the permits issued by the SAGARPA, when it has scientific and technical information to let the release allowed poses risks higher than expected that may negatively affect the environment and biological diversity, and

III. The exercise of the powers established in Sections I, II, IV, V, VII and VIII of Article 11 of this Law.

The biosafety opinion referred to in section I of this article will be binding, prior to the granting of the permits to be issued to the SAGARPA, and will be issued in the Article 66 of this Law.

ARTICLE 16.- It is for the SSA to exercise the following powers in relation to GMOs:

I. Participate in the formulation and apply the general biosecurity policy;

II. Evaluate case by case studies that are developed and presented by stakeholders on the safety and potential risks of GMOs subject to authorization under the terms of Title V of this Law;

III. Resolve and issue the OGMs authorizations referred to in the previous fraction;

IV. Participate in the elaboration and issuance of the lists referred to in this Law;

V. Order and apply relevant security or enforcement measures, with technical and scientific basis and in the precautionary approach, in the terms of this Act;

VI. To request SEMARNAT or SAGARPA, in the case of technical and scientific support, to suspend the effects of the release permits to the environment of GMOs, where available information that the activity permitted by those Secretariats is likely to be higher than expected risks that could affect human health;

VII. Inspect and monitor compliance with this Law, its official Mexican regulations and standards;

VIII. Impose administrative penalties for persons who violate the provisions of this Law, their regulations and the Mexican official rules deriving from this Law, without prejudice, where appropriate, to the penalties for the acts or omissions of violations of this order are also constitutive of crime, and of the civil liability that may result, and

IX. The others that this Act confers on you.

The SSA will carry out the health and epidemiological surveillance actions of the GMOs and the products containing them and the products derived thereof, in accordance with the General Health Law and its provisions. regulations.

ARTICLE 17.- In case of accidental release of GMOs, the Secretariats will coordinate so that, in the field of their respective competences under this Law, they will impose the necessary measures to avoid negative effects on biological diversity, on human health or animal, plant and aquaculture health, as the case may be.

ARTICLE 18.- It is for the SHCP to exercise the following powers, with respect to the importation of GMOs and products containing them:

I. Review in the customs of entry into the national territory, that the GMOs that are imported and intended for release to the environment or for the purposes set out in Article 91 of this Law, have the permission and/or the respective authorization, as the case may be in the terms of this order;

II. Review that the documentation accompanying the OGMs that are imported into the country, contains the identification requirements set out in the Mexican official rules resulting from this Law;

III. To participate, jointly with the Secretariats, in the issuance of official Mexican rules regarding the storage or storage of GMOs or products containing them in the enclosures customs of the national territory;

IV. Give immediate notice to the SEMARNAT, the SAGARPA and/or the SSA, on the probable commission of violations of the precepts of this Law, regarding the importation of GMOs, and

V. Prevent the entry into the national territory of GMOs and products containing them, in cases where such organisms and products do not have permission and/or authorisation, as appropriate, for their import, in accordance with this Law.

The SHCP shall exercise the above powers, without prejudice to customs legislation, applicable to the import of all goods.

CHAPTER IV Coordination and

ARTICLE 19.- The CIBIOGEM is an Intersecretarial Commission that aims to formulate and coordinate the policies of the Federal Public Administration regarding the biosafety of GMOs, which have the functions to establish the regulatory provisions deriving from this Law, in accordance with the following bases:

I. The CIBIOGEM will be made up of the holders of the Secretariats of Agriculture, Livestock, Rural Development, Fisheries and Food; Environment and Natural Resources; Health; Public Education; Finance and Public Credit, and Economy, as well as by the Director General of CONACYT;

II. The CIBIOGEM will have a Presidency that will be rotating among the holders of the Secretariats of Agriculture, Livestock, Rural Development, Fisheries and Food, Environment and Natural Resources and Health, and the exercise, functions and duration of which shall be determined in the relevant regulatory provisions. There shall also be a Vice-Presidency whose holder shall be the Director General of CONACyT, who shall preside over the sessions in the absence of the President, shall contribute to the Commission and the Executive Secretary in the performance of his duties and shall carry out the activities entrusted to it by the CIBIOGEM itself in terms of the regulatory provisions deriving from this Law;

III. The CIBIOGEM may invite other dependencies to participate, with a voice, in the agreements and decisions of matters relating to its object, as well as to the members of the Advisory Board;

IV. The CIBIOGEM will have an Executive Secretary who will be appointed by the President of the Republic, on a proposal from the Director General of CONACyT, approved by the CIBIOGEM itself. It shall have the powers and powers to be determined in the regulatory provisions deriving from this order, and shall implement and follow up the agreements of the Commission itself and exercise the other functions entrusted to it;

V. The Executive Secretariat of the CIBIOGEM will have the organic structure approved in the terms of the applicable provisions, and will be considered an administrative unit based on the CONACyT, in accordance with the Organic Law of that State-owned entity, and

VI. The CIBIOGEM will also have a Technical Committee composed of the coordinators, directors-general or equivalent competent in the field that appoint the owners of the dependencies and entities that are part of the CIBIOGEM. The Committee may propose the creation of specialised sub-committees for the attention of specific cases and shall have the powers to be determined in the regulatory provisions arising from this Act.

ARTICLE 20.- The Scientific Advisory Board of the CIBIOGEM is created which will serve as a mandatory consultation organ of the CIBIOGEM itself in technical and scientific aspects in modern biotechnology and biosafety of GMOs. It will be integrated by a set of experts in different disciplines, from centres, research institutions, academies or scientific societies of recognised prestige, which will exercise their function in a personal capacity, regardless of the the institution, association or undertaking of which they are a party or in which they provide their services. Such experts shall express expressly in a letter of commitment, at the time of their appointment as members of the Scientific Advisory Board, that they have no conflict of interest.

The selection of the members of the Scientific Advisory Board will be carried out by means of public convocation jointly issued by CONACyT and the Scientific and Technological Consultative Forum provided for in the Law of Science and Technology. The functions of the Advisory Board shall include the formulation of research protocols, analyses and methodologies and technical opinions, which may be remunerated. The specific functions of the Advisory Council and the mechanisms for the renewal of its members to be progressive and staggered will be established in the regulatory provisions deriving from this Law. The technical opinions issued by the Scientific Advisory Board shall be considered by the CIBIOGEM in the decisions it takes.

ARTICLE 21.- The CIBIOGEM Joint Consultative Council is created which will serve as an auxiliary body for consultation and opinion of the CIBIOGEM itself. It will be integrated by representatives of associations, chambers or companies from the private, social and productive sectors. Its fundamental role will be to know and to have an opinion on social, economic, and other aspects related to regulatory and development policies, as well as priorities in the standardization and improvement of procedures and procedures in the biosafety of GMOs. The specific functions of the Joint Consultative Council and the mechanisms for the incorporation of its members shall be established by the CIBIOGEM.

ARTICLE 22.- The CIBIOGEM will issue its rules of operation in which participation mechanisms will be established for members and representatives of the academic, scientific, technological, social and productive, of recognized prestige and experience in the issues directly related to the activities that are the subject of this Law, can participate by means of opinions, studies and consultations in the knowledge and evolution of the policies Biosafety and the promotion of research in bio-security and biotechnology, as well as for receiving opinions, studies and consultations on these subjects.

ARTICLE 23.- The CONACyT will have in its budget the resources necessary for the development of the activities of the CIBIOGEM, the Executive Secretariat and the Scientific Advisory Council, as the budget to be authorised in the terms of the applicable provisions. These resources shall be administered and exercised by the Executive Secretary of the CIBIOGEM.

The programs, projects, supports, as well as the other actions that are carried out by the application of this Law and other provisions in the field, in which resources of federal character are exercised, subject to the availability of resources to be determined for that purpose in the Federation of the Federation of the Federation of the Fiscal Year concerned, and shall observe the applicable budgetary provisions.

ARTICLE 24.- The Secretariats will be able to establish scientific technical committees to provide them with support in the resolution of applications for permits and authorizations, as well as for notices. The regulatory provisions of this Law shall determine the basis for the organisation and operation of such committees.

CHAPTER V Coordination with Federative

ARTICLE 25.- The Federation, through the Secretariats in the field of its competence and in the terms of the applicable provisions, with the knowledge of the CIBIOGEM, may conclude conventions or coordination agreements with the governments of the federative entities, with the purpose of:

I. Establish concurrent collaboration in monitoring the risks that may result from the release of GMOs to the environment, whether experimental or pilot, to be determined in such agreements or agreements, and

II. Where appropriate, in carrying out actions to monitor compliance with the provisions of this Law.

ARTICLE 26.- The coordination agreements or agreements signed by the Federation with the governments of the federative entities for the purposes referred to in the previous article must be adjusted to the applicable provisions and to the following bases:

I. Define precisely the subjects and activities that constitute the object of the agreement or agreement;

II. The purpose of the agreements or agreements must be consistent with the policy on biosecurity;

III. The goods and resources provided by the parties will be described clarifying what their specific destination and form of administration will be, for which the Federation will contribute to the strengthening of its financial and institutional capacities;

IV. The necessary means, procedures and resources to be provided by the competent Secretariats shall be determined, in order to enable the governments of the federative entities to carry out the actions and the activities covered by the coordination agreements or agreements;

V. The validity of the agreement or agreement, its forms of termination and settlement of disputes, and, where applicable, of extension, shall be specified;

VI. They will define the organ or organs that will carry out the actions resulting from the coordination agreements or agreements;

VII. Stop actions to promote and participate jointly in supporting scientific and technological research in biosafety and biotechnology;

VIII. The obligation to submit detailed reports on compliance with the object of the coordination agreements and agreements will be established, and

IX. Contain the other stipulations that the parties deem necessary for the proper compliance of the agreement or agreement.

The conventions referred to in this article shall be published in the Official Journal of the Federation and in the official dissemination organ of the respective local government.

ARTICLE 27.- The governments of the federal entities will have permanent access to the information that is entered in the National Register of Biosafety of the Genetically Modified Organisms. In addition, the CIBIOGEM, through its Executive Secretariat, shall notify the applications for commercial release permits to the environment of GMOs, to the governments of the federal entities in which the activity is intended to be carried out, to effect of having knowledge of that situation and being able to express their views in the terms of this Law. The notification shall be made within 20 days of the date on which the CIBIOGEM has received the corresponding permit application for registration in the Register.

CHAPTER VI From Promotion to Scientific and Technological Research in Biosafety and Biotechnology

ARTICLE 28.- The Federal Executive will encourage, support and strengthen scientific and technological research on biosafety and biotechnology through policies and instruments. established in this Law and in the Law of Science and Technology. In the field of biotechnology, these support will be aimed at promoting research and development and innovation projects, training of specialized human resources and strengthening of groups and infrastructure of universities, institutions of higher education and public research centres, which are carried out to address the country's specific production needs and directly benefit the national producers.

In the field of biosafety, research will be encouraged to obtain sufficient knowledge to assess the possible risks of GMOs in the environment, biological diversity, human health and animal, plant and aquaculture health; to generate the socio-economic considerations of the effects of such organisms for the conservation and exploitation of biological diversity, and to assess and verify the information provided by the promote. The creation of human, institutional and infrastructure capacities for risk assessment and monitoring will also be enhanced.

ARTICLE 29.- In order to promote scientific and technological research in the field of biosafety and biotechnology, a program for the development of biosafety and biotechnology will be established. biotechnology to be considered as a program whose formulation will be in charge of CONACyT based on the proposals presented by the Secretariats and other agencies and entities of the Federal Public Administration that support or carry out scientific research and technological development. This process will take into account the opinions and proposals of the scientific, academic, technological and productive communities, convened by the Scientific and Technological Consultative Forum, and the CIBIOGEM.

This program will be part of the Special Science and Technology Program established by the Science and Technology Act.

ARTICLE 30.- The program for the development of biosafety and biotechnology must contain, at least, diagnostics, policies, strategies and general and sectoral actions in terms of:

I. Scientific research;

II. Innovation and technological development;

III. Training of researchers, technologists, and high-level professionals;

IV. Support for public research centers;

V. Projects of scientific research and innovation and technological development aimed at solving national problems and in activities that benefit producers agricultural, forestry and aquaculture in the country;

VI. New research and technology transfer centers in primary areas of national development, in accordance with local or regional conservation and environmental or environmental protection needs. Forestry, agricultural and industrial production;

VII. Dissemination of scientific and technological knowledge;

VIII. National and international collaboration;

IX. Strengthening the culture of biosecurity, and

X. Decentralization and regional development.

The Federal Executive, through the competent Secretariats, will make sure to make available to the seed companies of the farmers 'and producers' organizations, preferably and accessible, the results of scientific and innovation research and technological development contained in the Programme for the development of biosafety and biotechnology.

ARTICLE 31.- CONACyT will be a Fund for the Promotion and Support of Scientific and Technological Research in Biosafety and Biotechnology in accordance with the Law of Science and Technology, to which allocate the tax resources to be provided by the agencies and entities for this purpose, third party resources, and revenues which, by way of rights, determine the tax provisions resulting from acts carried out in accordance with this Law.

TITLE SECOND Permissions

CHAPTER I Common Provisions

ARTICLE 32.- You will require permission to perform the following activities:

I. The experimental release to the environment, including the import for that activity, of one or more OGMs;

II. The release to the environment in pilot program, including the import for that activity, of GMOs, and

III. The commercial release to the environment, including the import for that activity, of GMOs.

ARTICLE 33.- Once the corresponding Secretaries receive an application for release permission to the environment of GMOs, and as long as it complies with the information and requirements set forth in This Law must be sent to the Registry for registration and publicity. Once this has been done, the Secretariat to which the request for permission to release OGMs to the environment should be resolved, will make that request available to the public for public consultation, and the forecasts will be observed. confidentiality laid down in this Law. The Secretariat may make use of the means it deems appropriate to make the request for the permit available to the public.

Any person, including the governments of the federal entities in which the respective release is intended, may issue their opinion, which must be technically and scientifically substantiated, within a period not longer than 20 working days from the date on which the respective application is made available to the public in the terms of this Article.

Opinions issued in accordance with the above paragraph shall be considered by the relevant Secretaries for the establishment of additional biosecurity measures, in case to issue the release permit for GMOs to the appropriate environment, in the terms of this Law.

ARTICLE 34.- The corresponding Secretariat shall issue its resolution, duly founded and reasoned, after analyzing the information and documentation provided by the interested party, the opinion or the opinion that have issued the Secretariats to which they are required to issue them in accordance with this Law and, where applicable, the authorisation of the GMO issuing the SSA in the terms of this order. The relevant Secretariat in its resolution may:

I. Exorder permission for the release of the release activity to the environment in question, and may establish additional monitoring, control, prevention, and security measures to which they were proposals by the interested party in the permit application, or

II. Negate the permission in the following cases:

A) When the application does not comply with what is established in this Law or the Mexican official rules as requirements for the granting of the permit;

B) When the information provided by the data subject, including the information regarding possible risks that may be caused by the OGMs, is false, incomplete or insufficient, or

C) When the relevant Secretariat concludes that the risks that the GMOs concerned may present, they will adversely affect human health or biological diversity, or health animal, plant or aquaculture, and may cause serious or irreversible damage.

ARTICLE 35.- The time limits set forth in this Law for the resolution of an application for release permit to the environment of OGMs, either experimental or in pilot program, will be extendable, in case of the person concerned does not have the authorisation issued by the SSA in the terms of this order, provided that such authorisation is a requirement for the issue of the respective permit.

ARTICLE 36.- The permits for experimental release, in the pilot or commercial program of GMOs to the environment, will have the effect of import permits from these organisms to be released in form experimental, in pilot or commercial program, as the case may be, in terms and conditions that are established in the permits themselves. The above, without prejudice to the importation of the GMOs concerned, shall be subject to the plant protection or aquaculture regime laid down in the relevant legislation.

ARTICLE 37.- The monitoring, prevention, control and safety measures of the possible risks of the use of the GMO that the corresponding Secretariat establishes in the permits, will be able to understand among others, the following aspects:

I. Managing the GMO;

II. Security measures so that the possible risk remains within the tolerance limits accepted in the assessment, and

III. Monitoring the activity in question, in relation to the possible risks that such activity might generate.

ARTICLE 38.- The Secretariat issuing the permit may modify the monitoring, control and prevention measures, require the person concerned to implement new measures, as well as suspend or revoke the permission, after a hearing to be granted to the persons concerned, where scientific or technical information is available to the effect that the activity may pose risks higher or lower than those originally provided for in the studies corresponding. The above must be set out in the permits issued by the competent Secretaries.

ARTICLE 39.- The permit holder shall be obliged to observe and comply with the monitoring, prevention, control and security measures that the permit establishes, as well as the provisions of this order, its regulations and the official Mexican rules which derive from it, which are applicable to the release in question. Failure to comply with the measures and provisions referred to in this Article shall give rise to the determination of the respective liability and the application of the penalties corresponding to this Law.

ARTICLE 40.- The importation of GMOs or products containing them into the national territory shall not be permitted in cases where such organisms are prohibited in the country of origin or are prohibited. they are classified in the lists as not permitted for commercial release or for importation for that activity.

ARTICLE 41.- It is prohibited to carry out activities with GMOs or any other organism whose purpose is the manufacture and/or use of biological weapons.

CHAPTER II Requirements for Getting Permissions

SECTION I Permission for experimental release to the environment

ARTICLE 42.- The application for permission to perform the experimental release to the environment of GMOs, including its import for that activity, shall be accompanied by the following information:

I. Characterization of the GMO, in which it is necessary to consider what the Mexican official norms that derive from this Law will establish for each case;

II. The identification of the area where the GMO is intended to be released experimentally, including the specification of the total surface at which the release will be performed;

III. A study of the possible risks that the release of GMOs could generate to the environment and biological diversity. In addition, in cases falling within the competence of SAGARPA, the study shall contain as regards the possible risks that the release of such organisms may cause to animal, plant or aquaculture health;

IV. The measures and procedures for monitoring the activity and biosecurity, which will be carried out at the time of the release and subsequent to the release;

V. Where appropriate, the history of release of the GMOs concerned in other countries;

VI. Where appropriate, consideration will be given to the risks of the technological alternatives that are available to meet the problem for which the genetically modified organism was built. modified to be released, and

VII. The information for each case to determine the Mexican official rules that derive from this Law.

It will be a requirement to obtain the experimental release permit for the environment, which the applicant will have the authorization of the GMO issued by the SSA in accordance with this Law, when the agency has public health purposes or is intended for bioremediation. The person concerned may initiate the procedure to obtain such permission from the competent Secretariat, but shall not be granted until he has obtained the authorization of the SSA in the respective file.

ARTICLE 43.- Those interested in importing GMOs for experimental release into the environment, in addition to the provisions of the previous article, must attach to their application the information and documentation to prove that the GMO is permitted under the legislation of the country of origin, for release, at least, in an experimental stage, attaching for such purposes the official authorisation or documentation to protect the said situation.

ARTICLE 44.- The resolution to an application for permission for experimental release of GMOs shall be issued within a maximum of six months from the day following that in which the Secretariat the request for the permit has been received and the information provided by the person concerned is complete.

ARTICLE 45.- In the event that, after the granting of the permit, the experimental release of an OGM to the environment occurs as follows:

I. Any release modification that may increase or decrease potential risks to the environment and biological diversity, or

II. New scientific and technical information on such risks is available.

In such cases, the permit holder shall be obliged to:

A. Inform the appropriate Secretariat immediately, such a situation;

B. Review the monitoring and biosecurity measures specified in the documentation, and

C. Adopt the required biosecurity measures.

ARTICLE 46.- The holder of the experimental release permit must inform the Secretariat that he has issued it, by means of a report, the results of the release or the releases made in relationship to the possible risks to the environment and biological diversity. The characteristics and content of the report referred to in this article will be established in the Mexican official norms that derive from this Law.

ARTICLE 47.- The holder of the permit shall be obliged to immediately inform the corresponding Secretariat, any situation that in the performance of the permitted release, may increase or reduce potential risks to the environment, biological diversity and/or human health.

ARTICLE 48.- The corresponding Secretariat may limit the validity of the experimental release permit to the environment by considering the elements of the file.

ARTICLE 49.- The experimental releases to the environment of GMOs will be carried out under the terms and conditions established by the permit. Where such permission includes the realization of several releases of the same GMO in the same geographical area as the permit, the notice requirement for each release may be established in the permit.

SECTION II Permit for release to environment on pilot

ARTICLE 50.- The application for permission to release the OGMs environment in a pilot program, including its import for that activity, must be accompanied by the following information:

I. The permission for the experimental release of the GMO in question;

II. Reference and considerations on the report of the results of the or the experimental releases carried out in relation to the possible risks to the environment and biological diversity and, in addition to animal, plant or aquaculture health in cases which fall within the competence of SAGARPA in accordance with this Law;

III. Information about:

A) The total amount of the OGM to be released;

B) The handling conditions that will be given to the GMO, and

C) Identification of the areas where the GMO is intended to be released, including the specification of the total surface or surfaces in which the release will be performed.

IV. The monitoring and biosecurity measures to be performed during and after the release, and

V. The information for each case to determine the Mexican official rules that derive from this Law.

The above, with the aim that the relevant Secretariats have the information to carry out the analysis and assessment of possible risks to the environment and biological diversity or animal, plant or aquaculture health, as appropriate in accordance with this Law.

It will be a requirement to obtain the permit for release to the environment in a pilot program, that the applicant has the authorization of the GMO that the SSA expunts in accordance with this Law, when that organism is for human use or consumption. The person concerned may initiate the procedure to obtain such permission from the competent Secretariat, but shall not be granted until he has obtained the authorization of the SSA in the respective file.

ARTICLE 51.- Those interested in importing GMOs for release to the environment in pilot program, in addition to the provisions of the previous article, must attach to their request the information and documentation proving that the GMO is permitted under the law of the country of origin, for release, at least in this stage class, attaching for such purposes the official authorisation or documentation to support such a situation.

ARTICLE 52.- The resolution to a permit application for release to the environment of OGMs under pilot program shall be issued within a maximum period of three months from the day following that in the Secretariat to be resolved has received the request for the permit and the information provided by the person concerned is complete.

The validity of the permit will be determined by considering the elements of the case.

ARTICLE 53.- The holder of the permit for release to the environment in a pilot program, must inform the Secretariat that he issued it, by means of a report, the results of the release or the releases made in relationship to the possible risks to the environment and biological diversity. The characteristics and content of the report referred to in this article will be established in the Mexican official norms that derive from this Law.

ARTICLE 54.- The holder of the permit shall be obliged to immediately inform the corresponding Secretariat, any situation that in the performance of the permitted release, may increase or reduce potential risks to the environment, biological diversity and/or human health.

SECTION III Permit for commercial release to the environment

ARTICLE 55.- The application for the permit to perform the commercial release to the environment of GMOs, including its import for that activity, shall be accompanied by the following information:

I. The permissions for the experimental release and pilot program of the GMO in question;

II. Reference and considerations on the results reports of experimental release and pilot release that have been performed, in terms of the permits referred to in the Previous fraction;

III. Instructions or specific recommendations for storage, transport, and, where applicable, handling;

IV. Where appropriate, conditions for release and marketing;

V. Where appropriate, consideration will be given to the risks of the technological alternatives to which the problem for which the GMO was constructed is constructed. release;

VI. Where appropriate, the information available to the applicant on data or results of the marketing of the same GMO in other countries, and

VII. Other information to determine the Mexican official rules deriving from this Law.

The above, with the aim that the relevant Secretariats have the information to carry out the analysis and assessment of possible risks to the environment and biological diversity or animal, plant or aquaculture health, as appropriate in accordance with this Law.

ARTICLE 56.- Interested in importing OGMs for commercial release, in addition to the provisions of the previous article, must attach the information and documentation that accredit that the GMO is permitted under the legislation of the country of origin for placing on the market, together with the official authorisation or documentation for such purposes.

ARTICLE 57.- The resolution to an application for a permit for commercial release to the environment must be issued within four months from the day following that in which the Secretariat the request for the permit has been received and the information provided by the person concerned is complete.

ARTICLE 58.- The subsequent activities and imports of the commercial release permit to the environment shall be made subject to the terms and conditions laid down therein, and without require successive permissions. Subsequent imports shall be understood to be carried out on the same terms and conditions laid down in the respective commercial release permit, in the case of the same GMO and the same release area. The above, irrespective of whether such activities and imports may be subject to monitoring and inspection and surveillance actions, in the terms of this Law.

ARTICLE 59.- The commercial release permit to the environment of a GMO carries the marketing authorization of the organism concerned and the products containing it, in the terms of the Law.

CHAPTER III Risk Assessment and

ARTICLE 60.- The risk assessment is the process by which they are analyzed on a case-by-case basis, based on scientific and technically substantiated studies to be developed by the interested parties. risks or effects that experimental release to the environment of GMOs can cause to the environment and biological diversity, as well as animal, plant and aquaculture health.

The possible risks to human health will be the subject of a risk study to obtain the authorization of the GMO in question, in the terms of this Law.

ARTICLE 61.- To perform the study and the risk assessment, the following guidelines should be observed:

I. Should be done on a case by case basis in a transparent and scientific principles and in the precautionary approach, in the terms of this Law, taking into account expert advice;

II. They will be performed in the relevant craft fields;

III. Lack of scientific knowledge or consensus shall not necessarily be construed as an indicator of a particular level of risk, absence of risk, or the existence of an acceptable risk;

IV. They should have as a minimum basis the possible risks that would be imposed by the release of the non-genetically modified host organisms or parental organisms, when they were released in that environment;

V. The receiving organism, genetic modification, including genetic construction and insertion method, and the environment in which the GMO is intended to be released, should be considered, and

VI. The nature and level of detail of the information they contain may vary from case to case, depending on the GMO concerned, its intended use and the likely receiving environment.

ARTICLE 62.- The basic steps to be followed in the study and risk assessment are as follows:

I. The identification of new features associated with GMOs that may have potential risks in biological diversity;

II. The assessment that these potential risks actually occur, taking into account the level and type of exposure of GMOs;

III. The assessment of the consequences if possible risks would actually occur;

IV. The estimation of the possible global risk posed by the GMO, based on the assessment of the likelihood that the possible risks and the identified consequences will actually occur, and

V. The recommendation on whether the possible risks are acceptable or manageable, or are not, including the determination of strategies for handling those potential risks.

ARTICLE 63.- When there is uncertainty about the level of the possible risk that GMOs may cause to biological diversity, the corresponding Secretariats will apply within the procedure. (i) administrative permission for the release activity to the environment of GMOs in question, additional information on specific questions of the risk study, or will adopt appropriate strategies for risk management and/or monitoring of the GMOs in the receiving environment.

In case of danger of serious or irreversible damage, uncertainty about the level of possible risks that GMOs may cause to biological diversity or human health should not be used as a reason for the appropriate Secretariat to postpone the adoption of effective measures to prevent the negative impact of biological diversity or human health. In the adoption of such measures, the relevant Secretariat shall take into account the existing scientific evidence which serves as a basis or criterion for the establishment of the measure or measures; the administrative procedures laid down in this Law, and the commercial normativity contained in treaties and international agreements of which the United Mexican States are a party.

ARTICLE 64.- The interested party may submit further to the study of the possible risks, other studies or considerations in which the contribution of the GMO to the solution of the environmental, social, productive or other problems, the socio-economic considerations that exist with respect to the release of GMOs to the environment, such as an assessment of the risks of alternative technological options to meet with the specific problem for which the GMO was designed. These analyses must be supported by scientific and technical evidence, in the background on use, production and consumption, and may be considered by the competent Secretariats as additional elements to decide on the release. (a) experimental environment, and consequent releases to the environment in pilot and commercial programmes, respectively, of the GMO concerned.

ARTICLE 65.- The characteristics and requirements of the evaluation studies of the possible risks will be established in the Mexican official norms that derive from this Law.

CHAPTER IV Of

ARTICLE 66.- The opinions to be issued by SEMARNAT will only be required in the case of experimental release, pilot-release activities and commercial release of GMOs. which are of competence of the SAGARPA. Such opinions shall be issued within 60 days from the date of receipt by the SEMARNAT of the administrative file referred to it by the SAGARPA. This period includes both the issue of the relevant opinion and its referral to SAGARPA. SAGARPA shall issue the release permit for GMOs to the appropriate environment, provided that the opinion issued by SEMARNAT is favourable.

CHAPTER V The Review of Negative

ARTICLE 67.- Interested parties to whom the corresponding Secretariat has refused the requested permission, may request the said Secretariat to review the respective resolution, when Consider that:

I. There has been a change in circumstances that can influence the outcome of the study of the possible risks on which the resolution was based, or

II. New scientific or relevant technical information is available from which the possible risks identified are not originally intended.

The competent Secretariat may issue a resolution within two months. In the event of failure to do so, the review shall be rejected.

ARTICLE 68.- The review referred to in the previous article does not constitute a resource or means of defense, and may be promoted by the interested parties regardless of whether they assert the the means of impeachment established in this Law against the resolution affecting them.

CHAPTER VI Permissions

ARTICLE 69.- The corresponding Secretariat, at any time and on the basis of new scientific or technical information about the possible risks that GMOs may cause to public health or the environment and biological diversity, may review the permits granted and, where appropriate, suspend their effects or revoke such permits, in accordance with the procedures laid down by the regulatory provisions deriving from this Law, when you consider to be causes that:

I. A change in the circumstances of the activities that may influence the outcome of the assessment of the assessment of the possible risks on which the permit was based, or

II. Additional scientific or technical information is available that could modify any conditions, limitations, or requirements of the permit.

CHAPTER VII

ARTICLE 70.- Interested parties may clearly identify in their application for permission that information to be considered as confidential under the industrial property or rights regime. author. The corresponding Secretariat shall be subject to the laws of the matter and shall refrain from sending the information and data protected by such laws to third parties.

ARTICLE 71.- They will not have the character of confidential:

I. The general description of the OGMs;

II. The identification of the person or person responsible for the activity;

III. The purpose and place or places of the activity;

IV. Systems and measures for biosecurity, monitoring, control, and emergency, and

V. Studies on possible risks to human health or the environment and biological diversity.

Access to the information referred to in the above fractions shall also be governed by the applicable provisions on access to government public information.

CHAPTER VIII Exporting GMOs to be released to the environment in other countries

ARTICLE 72.- Those interested in exporting GMOs that are destined for release to the environment in other countries, shall notify each other, as determined by the regulatory provisions resulting from this Law, its intention to export such organisms, to the competent authorities of the respective country. Such notification shall only be made in cases where the international treaties and agreements in which the United Mexican States are a party, establish that requirement to carry out the export to the country concerned. The information that the person concerned attaches to the notification referred to in this Article shall be accurate, reliable and in accordance with the provisions of such international treaties and agreements.

THIRD TITLE Of Confined Use and

CHAPTER I Confined

ARTICLE 73.- The contained use of GMOs may be for teaching, scientific and technological, industrial or commercial purposes.

ARTICLE 74.- Those who perform contained use activities subject to the notice filing requirement in the terms of this Act shall comply with the following:

I. Take a record book of the contained use activities that you perform, which must be provided to the appropriate Secretariats upon request;

II. Apply the containment measures whose execution should be adapted to the most modern and advanced scientific and technical knowledge in the field of risk management and treatment, final and disposal of waste from GMOs generated in the performance of the activity, and

III. In the case of confined use for the purposes of teaching or scientific and technological research, integrating an internal biosecurity commission and applying the principles of good practice of scientific research, as well as the biosafety rules defined by the internal biosafety commission. Such internal committee shall be in charge of safety at the premises and of good practice and safety in the handling of GMOs used in the activity identified.

The Mexican official rules deriving from this Law will establish:

A) The requirements and general characteristics to be contained in the log book referred to in this article, for each type of activity;

B) The requirements and characteristics relating to the confinement, treatment, final disposal, destruction and disposal of OGMs; waste

C) The handling conditions that are required in the various forms of confined use of such organisms, and

D) Actions to be performed in case of accidental release of GMOs.

ARTICLE 75.- The storage or storage of GMOs or products containing them, to be carried out by at the customs of the national territory, shall be subject to the provisions of the official rules Respective Mexican authorities to jointly issue the competent Secretariats, with the participation of the SHCP.

ARTICLE 76.- The transport of GMOs or products containing them, as well as the transit of such organisms and products through the national territory, when they are destined for another country, shall be governed by the official Mexican rules to be jointly issued by the competent Secretariats, with the participation of the Secretariat of Communications and Transport.

CHAPTER II Of The

ARTICLE 77.- The notice is the communication to be presented in official formats by the subjects mentioned in this Law, to the SEMARNAT or to the SAGARPA, as appropriate in accordance with this order. of the contained use of GMOs in the cases set out in this chapter.

ARTICLE 78.- The notices must be submitted to the SEMARNAT or to the SAGARPA, in accordance with the privileges that this Law confers on them, in the official formats that are issued for this purpose. The content of the formats will be determined by these Secretariats, with the prior approval of the Federal Regulatory Improvement Commission. Such formats shall determine the information and documentation to be submitted by the data subject. The formats must be published in the Official Journal of the Federation.

ARTICLE 79.- Refuse warning presentation:

I. The GMOs that are handled, generated, and produced for the purposes of scientific and technological teaching and research;

II. The integration of internal biosecurity commissions, including the name of the or those responsible for such commissions;

III. The first use of specific laboratories or facilities of scientific and technological teaching or research in which OGMs; are managed, generated and produced

IV. The production of GMOs that are used in industrial processes, and

V. The first use of specific installations where the GMOs are produced to which the previous fraction refers.

ARTICLE 80.- Also requires notice of the import of GMOs for their contained use for industrial or commercial purposes only when the following assumptions are met:

I. That is OGMs that do not require permission, by virtue of being exclusively intended for their contained use and therefore not imported for release into the environment, and

II. For GMOs that do not require health authorization because they will not be used for human consumption or for public health purposes.

ARTICLE 81.- The subjects to present to the corresponding Secretariat the respective notice are as follows:

I. In the cases referred to in Article 79, fractions I, II and III, the person responsible for the internal biosecurity commission of the institution, centre or undertaking in which the activities are carried out for scientific and technological education and research in which the GMO concerned is generated and produced;

II. In the cases referred to in Article 79 (IV) and (V), the legal representative of the undertaking in which the GMOs in question are produced, and

III. In the case referred to in the previous article, the importer of the GMO.

ARTICLE 82.- Except for the presentation of notice, the contained use or import for that activity, in case the GMO concerned is exempted from that requirement in the lists that they issue Secretaries in accordance with this Law.

ARTICLE 83.- The contained use of GMOs and the importation of such organisms for that activity may be carried out from the moment the internal biosecurity commission or the importer, in question, please submit the respective notice to the relevant Secretariat.

ARTICLE 84.- Once the notice is presented, the corresponding Secretariat may determine, if appropriate, with scientific and technical support:

I. That in consideration of the genetically modified organism and the possible risks in its handling, the activity should be suspended;

II. Where appropriate, it may resolve that the contained use requires the adoption and implementation of additional biosecurity requirements and measures to those identified by the person concerned in the notice, which shall be determined by that Secretariat, and shall be observed and fulfilled by the person concerned to continue the performance of the activity

or

III. The prohibition of the contained use of the genetically modified organism concerned or its importation for that activity.

Such a resolution may be challenged through the review facility established in this order.

ARTICLE 85.- Persons whose contained use activity is subject to the notice requirement shall be obliged to observe and comply with the other provisions of this Regulation. and of the Mexican official rules that derive from it, in whatever applies to it.

TITLE FOURTH Restricted

CHAPTER I Centers of Origin and Genetic

ARTICLE 86.- The species that the United Mexican States is a center of origin and genetic diversity as well as the geographical areas in which they are located, will be determined jointly. by means of agreements by SEMARNAT and SAGARPA, based on the information they have in their archives or in their databases, including the one that provides, among others, the National Institute of Statistics, Geography and Informatics, the Institute National of Forestry, Agricultural and Livestock Research, the National Institute of Ecology, the National Commission for the Knowledge and Use of Biodiversity and the National Forestry Commission, as well as international agreements and treaties concerning these matters. SEMARNAT and SAGARPA shall establish in the agreements they issue, the necessary measures for the protection of these species and geographical areas.

ARTICLE 87.- For the determination of the centers of origin and genetic diversity, the following criteria will be taken into account:

I. To be considered centers of genetic diversity, understanding these regions that currently house populations of the wild relatives of the GMO in question, including different breeds or varieties thereof, which constitute a genetic reserve of the material, and

II. In the case of crops, the geographical regions where the organism concerned was domesticated, as long as these regions are centers of genetic diversity.

ARTICLE 88.- In the centres of origin and genetic diversity of animal and plant species only releases of GMOs will be permitted in the case of GMOs other than species native, provided that their release does not cause a negative impact on human health or biological diversity.

CHAPTER II Activities with GMOs in Protected Natural

ARTICLE 89.- In protected natural areas created in accordance with the provisions of the subject, only activities with GMOs for bioremediation purposes will be permitted, in cases where they appear pests or pollutants that could endanger the existence of animal, plant or aquaculture species, and GMOs have been created to prevent or combat such a situation, provided that the necessary scientific and technical elements are available to bear the environmental benefit to be obtained, and such activities are permitted by SEMARNAT in the terms of this Law.

For the purposes of the foregoing paragraph, it is prohibited to engage in activities with GMOs in the core areas of protected natural areas.

In the event that any center of origin or center of genetic diversity is located within a protected natural area, the declaratory of creation and the programs of management of these areas will be modified in the terms of the law of the matter, as determined by the determinations referred to in Article 86 of this Law.

CHAPTER III OGMs Free

ARTICLE 90.- Free zones of GMOs may be established for the protection of organic and other agricultural products of interest of the requesting community, in accordance with the following guidelines general:

I. Free zones shall be established in the case of GMOs of the same species as those produced by processes of production of organic agricultural products, and shall be shown to be scientific and technically that their coexistence is not viable or that they would not meet the regulatory requirements for their certification;

II. These zones will be determined by the SAGARPA by means of agreements that will be published in the Official Journal of the Federation, after the opinion of the CIBIOGEM, with the opinion of the National Commission for the Knowledge and Use of Biodiversity, taking into account the established Mexican official standards for organic agricultural products;

III. The determination of the free zones will be performed based on the following requirements:

A. It will be made at the written request of the interested communities, through their legal representative;

B. Such an application shall be accompanied by the favourable opinion of the governments of the federative entities and the municipal governments of the places or regions to be determined as free zones;

C. Assessments of the effects that GMOs may have on organic agricultural product production processes or on biodiversity, through which it is demonstrated, will be carried out. scientifically and technically, that their coexistence is not viable or they do not comply with the normative requirements for their certification, according to the Mexican official standards issued by the SAGARPA. The above assessments shall be carried out as established by that Secretariat in Mexican official standards, and

IV. The SAGARPA will establish in the agreements the security measures that may be adopted in the areas free of GMOs, in order to guarantee the adequate protection of the organic agricultural products.

TITLE FIFTH Of Human Health Protection in relation to

CHAPTER I OGMs Authorizations

ARTICLE 91.- The OGMs object of authorization are as follows:

I. Those intended for human use or consumption, including grains;

II. Those that are intended for human consumption food processing;

III. Those that have public health purposes, and

IV. Those that are intended for bioremediation.

For the purposes of this Act, GMOs are also considered for human use or consumption for those that are for animal consumption and may be consumed directly by the human being.

ARTICLE 92.- The application for authorization of a GMO must be accompanied by the following requirements:

I. The study of the possible risks that the human use or consumption of the GMO in question could pose to human health, including the scientific and technical information relating to its safety, and

II. Other requirements to be determined in the Mexican official rules deriving from this Law.

The guidelines, criteria, characteristics and requirements of the studies of the possible risks that GMOs may cause to human health, will be determined by the SSA in Mexican official norms. issue under this Act.

ARTICLE 93.- In the case of applications for authorization of a GMO to be able to import for the purposes referred to in Article 91 of this Law, in addition to the provisions of the article above, the data subject shall attach the information and documentation certifying that the GMO is authorised in accordance with the legislation of the country of origin. Failing that, the person concerned shall state the absence of such a situation, and shall set out the elements of consideration which support the fact that the SSA is able to resolve the application for authorisation.

ARTICLE 94.- Once the SSA receives an application for authorization, and as long as it complies with the information and requirements set forth in this Law, it must forward it to the Registry, for its respective registration and advertising.

ARTICLE 95.- The authorizations must be issued within a period not longer than six months after the SSA receives the request for authorization from the data subject and the information provided in that request is complete.

ARTICLE 96.- The SSA will issue your resolution, once you have analyzed the information and documentation provided by the data subject. The Secretariat in its resolution may, on the basis of:

I. Exorder authorization, or

II. Negate authorization in the following cases:

A) When the application does not comply with what is established in this Law or the Mexican official rules as requirements for granting authorization;

B) When the information provided by the data subject is false, incomplete or insufficient, or

C) When the SSA concludes that the risks that such organisms may present will adversely affect human health, resulting in serious or irreversible damage.

The SSA will base its resolutions in accordance with scientific and technically substantiated identification of the possible risks that GMOs may generate, and the real possibility of human health by those bodies.

ARTICLE 97.- The GMOs authorized by the SSA may be freely marketed and imported for marketing, as may the products containing such organisms and products. derivatives of the same. The foregoing shall be without prejudice to the fact that the approved bodies, the products containing them and the products derived thereof are subject to the general health control system laid down by the General Health Law and their regulations and, if they are they are applicable, the relevant plant health requirements.

ARTICLE 98.- They shall be applicable to the administrative procedure of authorization, the provisions relating to Title II, in respect of the Review of Negative Resolutions, Review of the Permissions and Confidentiality.

CHAPTER II Additional

ARTICLE 99.- The packaging of GMOs and products containing them, for use or human consumption, will be governed by the Mexican official rules issued by the SSA, together with the Secretariat of Economy, compliance with the General Health Law and its regulatory provisions, and with the Federal Law on Metrology and Standardisation.

ARTICLE 100.- The development, production, marketing and in general process of GMOs with therapeutic effects, in addition to what is established in this Law, will be subject to the provisions of the General Law Health and other orders for medicinal products and drugs.

TITLE SIXTH Tagging and Identifying OGMs

ARTICLE 101.- The GMOs or products containing genetically modified organisms, authorized by the SSA for their safety in the terms of this Law and which are for direct human consumption, shall be to ensure the explicit reference of genetically modified organisms and to indicate on the label the information of their food composition or their nutritional properties, in cases where these characteristics are significantly (i) the Commission's proposal for a decision on the additional general labelling requirements in accordance with Mexican official standards issued by the SSA, in accordance with the provisions of the General Health Law and its regulatory provisions, with the participation of the Secretariat of Economy.

The information contained in the labels, as set out in this article, must be truthful, objective, clear, understandable, useful to the consumer and supported by scientific and technical information.

The labeling of GMOs that are seeds or vegetative material destined for sowing, cultivation and agricultural production will be subject to the official Mexican norms that the SAGARPA will issue with the participation of the Secretary for Economic Affairs. For this type of GMOs, it will be mandatory to record on the label that it is genetically modified organisms, the characteristics of the acquired genetic combination and their implications for special conditions and cultivation requirements, as well as changes in reproductive and productive characteristics.

The evaluation of the compliance of these Mexican official standards will be carried out by the SSA, the SAGARPA and the Secretariat of Economy in the field of their respective competencies and the accredited and approved persons. in accordance with the provisions of the Federal Law on Metrology and Standardisation.

ARTICLE 102.- The information requirements to be contained in the documentation accompanying the GMOs that are imported in accordance with this Law will be established in Mexican official rules that will result from the The purpose for which these agencies are to be used and what is established in international treaties for which the United Mexican States is a party. The Mexican official rules referred to in this article will be issued jointly by the SAGARPA, the SSA and the Ministry of Economy. In the event that the importation of GMOs is carried out for the purpose of their release to the environment, the Mexican official standards referred to in this article shall be issued by the Secretariats identified jointly with SEMARNAT.

SEVENTH TITLE of the OGMs

ARTICLE 103.- The lists of GMOs that are issued and published under this Law will be as follows:

I. Those of GMOs that have permission for their commercial release or import for that activity;

II. Those of GMOs that do not have permission for their commercial release or import for that activity;

III. Those of GMOs that are authorized by the SSA, and

IV. The OGMs to perform OGMs confined utilization activities for teaching and scientific and technological research purposes.

The lists of GMOs referred to in this Article shall be issued and published by the competent Secretaries with the periodicity laid down by the regulatory provisions deriving from this Law and (a) the provisions of this Title shall apply. They shall aim to make known to the stakeholders and to the general public the outcome of the resolutions they issue with respect to permit and permit applications.

ARTICLE 104.- The list of GMOs referred to in fractions I and II of the previous article will be prepared considering the results of the case-by-case assessment and jointly issued by the SEMARNAT, SSA and SAGARPA, and will be published for knowledge and dissemination in the Official Journal of the Federation.

The purposes of the list referred to in this article will be:

I. Indicate the legal status of those OGMs, and

II. Determine the cases in which OGMs allowed for commercial release or for importation for that activity can be freely released and imported into the geographical areas that are determine according to the case by case analysis.

In that list, the relevant Secretaries may indicate the cases in which the importation, use, handling and release of such organisms may be carried out without conditions, as well as the cases in which the they must meet specific conditions.

ARTICLE 105.- The list of GMOs that are authorized, will be prepared and issued by the SSA, considering the results of the assessment case by case of the possible risks of these organisms. for human health, and will be published for knowledge and dissemination in the Official Journal of the Federation. Its purposes shall be to indicate the legal status of those GMOs, and to determine the cases in which GMOs authorised under this Law may be marketed and imported.

ARTICLE 106.- The list of GMOs to carry out activities of the contained use of these organisms for the purposes of teaching and scientific and technological research will be jointly issued by the Secretariats, and will be published for knowledge and dissemination in the Official Journal of the Federation.

ARTICLE 107.- In the formulation, issuance and modification of the OGMs information lists, it shall be as laid down in the regulatory provisions deriving from this order, taking into account the following guidelines:

They will be formulated by:

I. The nature of the genetically modified organism;

II. The presence in the country or region of interest, of sexually compatible species with the genetically modified organism;

III. The type of sexual reproduction of the genetically modified organism and the sexually compatible native species;

IV. The nature of the receiving or parental organism;

V. The characteristics of the vector and the insert of genetic material used in the operation;

VI. The ability and manner of propagation of genetically modified organisms;

VII. The existence of wild family species in any area or region of the national territory that is its center of origin;

VIII. The scale or volume of handling, and

IX. The possible effects or risks that the various activities with such organisms may cause to the environment and biological diversity or to human health or animal, plant or animal health aquaculture.

TITLE VIII Biosafety

CHAPTER I Of The National Biosafety Information

ARTICLE 108.- The CIBIOGEM, through its Executive Secretariat, will develop the National System of Information on Biosafety that will be designed to organize, update and disseminate information on biosecurity. In that system, the CIBIOGEM shall, inter alia, integrate the information relating to the Register.

The CIBIOGEM will bring together relevant reports and documents resulting from scientific, academic, technical or other biosafety activities, including the safety of GMOs, carried out by natural or moral persons, national or foreign, which will be transmitted and organized by the National System of Information on Biosafety. In addition, it will draw up and publish annually a detailed report of the country's existing general situation in the field of biotechnology and bio-security.

The CIBIOGEM, in addition, will conduct studies and socio-economic considerations resulting from the effects of GMOs that are released to the environment in the national territory, and will establish mechanisms for to carry out the consultation and participation of indigenous peoples and communities in the areas where the release of GMOs is intended, considering the value of biological diversity.

The Executive Secretariat of the CIBIOGEM will also serve as the National Focal Point to the Secretariat of the Cartagena Protocol on Biosafety of the Convention on Biological Diversity, being responsible for the liaison with that Secretariat and for complying with the provisions of Article 19 of the International Treaty. The Executive Secretariat of the CIBIOGEM will also be responsible for providing the Biotechnology Security Information Exchange Center established in the aforementioned Protocol with any information on:

I. Existing national laws, regulations and guidelines for the application of the Protocol, as well as the information and documentation required, in terms of this Law, for the procedure administrative permission to import GMOs to be released on a pilot basis, in a pilot or commercially available programme;

II. Bilateral, regional, and multilateral agreements and arrangements;

III. Summaries of the risk assessments of GMOs, as well as relevant information on products derived from OGMs;

IV. Final resolutions on the import or release of the OGMs environment, as well as the modification of resolutions arising from its review under this Law;

V. The socio-economic effects of GMOs, especially in indigenous and local communities, and

VI. Reports on compliance with the obligations set out in the Protocol, including those relating to the application of the OGMs import procedure to be released to the environment in experimental form, in pilot or commercial program.

The competent Secretaries may provide directly to the Information Exchange Center on Biotechnology Security, the information referred to in the above fractions, reporting simultaneously to the Executive Secretariat of the CIBIOGEM.

CHAPTER II Of The National Biosafety Register of

ARTICLE 109.- The Registry, which will be in charge of the Executive Secretariat of the CIBIOGEM, will have a public character and is intended to include the registration of information regarding activities with GMOs, as well as as well as the bodies themselves. Its operation and what may be the subject of registration will be determined in the regulatory provisions deriving from this Law. SEMARNAT, SAGARPA and SSA will contribute to the organization and operation of the Registry.

TITLE NINTH Of The Mexican Official Standards on Biosafety

ARTICLE 110.- To ensure the biosafety of the activities with GMOs, the Secretariats, jointly or with the participation of other dependencies of the Federal Public Administration, will issue Mexican official rules that aim to establish guidelines, criteria, technical specifications and procedures in accordance with the provisions of this Law.

ARTICLE 111.- In the formulation of official Mexican standards in the field of biosafety, compliance with its provisions must be considered to have to be carried out in accordance with the of each activity or production process with GMOs.

ARTICLE 112.- The application of the official Mexican biosafety standards, as well as the inspection and surveillance acts will correspond exclusively to the Secretariats competent in the terms of this Law. Compliance with those standards may be assessed by the certification bodies, verification units and testing laboratories approved by those Secretaries in accordance with the regulatory provisions resulting from this Regulation. order and with the Federal Law on Metrology and Standardisation.

TITLE TENTH Inspection and Surveillance and Security or Application Urgent

CHAPTER I Inspection and Surveillance

ARTICLE 113.- In order to verify and verify compliance with this Law, its regulations and the Mexican official rules that derive from it, the competent Secretariats may perform through duly authorised personnel, the acts of inspection and surveillance that they deem necessary, through the legally empowered Administrative Units, in accordance with this Law.

ARTICLE 114.- For what it does to the requirements and formalities to be observed in the conduct of inspection and surveillance visits, the provisions are applicable to this Chapter. Chapter 1 of Title Third of the Federal Law of Administrative Procedure. In the case of restoration or compensation for damage to the environment or biological diversity, the provisions of the second paragraph of Article 168 of the General Law on Ecological Balance and Environmental Protection may apply.

CHAPTER II Security or Application Urgent

ARTICLE 115.- The Secretariats, in the field of their jurisdiction under this Law, will order some or some of the measures set out in this article, in the event that Activities with GMOs are presented as follows:

I. Surpose risks not originally intended, which may cause damage or adverse and significant effects to human health or biological diversity or animal, plant or aquaculture health;

II. Damage or adverse and significant effects to human health or biological diversity or animal, plant or aquaculture health are caused, or

III. Unpermitted and/or unauthorized OGMs are accidentally released into the environment.

In these cases, the measures can be as follows:

A. Temporary, partial or total closure of sites and/or facilities in which GMOs are handled or stored or activities that result in the assumptions arising from the imposition of the the measure;

B. The precautionary assurance of GMOs, in addition to the goods, vehicles, utensils and instruments directly related to the action or omission that gives rise to the measure;

C. The temporary, total or partial suspension of the activity that motivates the imposition of the measure;

D. The repatriation of GMOs to their country of origin;

E. The realization of the actions and measures necessary to prevent the continued presentation of the assumptions that motivate the imposition of the measure, and

F. The destruction of GMOs in question, at the expense of the data subject, for which the following must be addressed:

a) Shall proceed only in the event that the risks or damages are serious or irreparable, and only by imposing such a measure is it possible to avoid, mitigate or mitigate the risks or damages that the motivated;

b) In order to determine the imposition of the measure, the competent Secretariat shall issue an opinion, technically and scientifically substantiated, to justify the origin of the destruction of the GMOs in question, with the knowledge of the person concerned, so that he or she is within the next five days of what is appropriate and, where appropriate, provides the evidence with which he/she has access, and

c) As long as the competent Secretariat delivers the resolution that proceeds, it may order, in advance, the precautionary insurance of the GMOs, and may be carried out by the Secretariat itself or through the interested.

Also, the competent Secretariat imposing the measures referred to in this Article may promote to the other competent Secretariats, the execution of any or some measures to be established in other Orders.

ARTICLE 116.- When the competent Secretaries order one of the measures provided for in the previous article, they shall indicate to the data subject the actions to be carried out to remedy the irregularities which led to the imposition of those measures, as well as the time limits for their implementation, in order to ensure that the measures imposed are withdrawn after they have been fulfilled.

If the person concerned refuses to carry out the actions to remedy the irregularities that have led to the imposition of the measures in question, the Secretariat that has imposed them will do so. immediately, with total charge to the reluctant person.

In the case where the person concerned carries out the security measures or the urgent application or remedy the irregularities in which he has incurred, prior to the imposition of any or some of the measures by the competent Secretariat of the penalties provided for in this Law, such a Secretariat shall consider such a situation as mitigating the offence committed.

ARTICLE 117.- In case of accidental releases of GMOs that are verified on the national territory, and which may have significant adverse effects on biological diversity or human health another country, the competent Secretariat shall notify the relevant authority of the country concerned that it may be affected by such release. Such notification shall include:

I. Information about estimated quantities and important features and/or traits of the GMO;

II. Information about the circumstances and estimated date of accidental release, as well as the use of GMOs in the national territory;

III. Available information on possible adverse effects for biological diversity and human health;

IV. Available information about the possible regulatory, attention, and risk control measures, and

V. A point of contact for additional information.

Without prejudice to the foregoing, the Secretaries, within the scope of their jurisdiction under this Law, shall carry out the necessary actions and measures to minimize any risk or adverse effect that the GMOs released accidentally could cause. Such actions and measures shall be ordered by the Secretaries to whom the accidental release of GMOs has been caused to the environment, who shall comply with them immediately. Otherwise, the Secretaries shall proceed as set out in the second paragraph of the previous article.

ARTICLE 118.- The provisions of the Single Chapter of Title V of the Federal Administrative Procedure Law, except for the provisions of the Chapter, are applicable to this Chapter. Previous article.

TITLE 13TH Violations, Sanctions, and

CHAPTER I Of Infractions

ARTICLE 119.- Incurre in administrative infractions to the provisions of this Law, the person who, with full knowledge that it is OGMs:

I. Perform activities with GMOs without the respective permissions and authorizations;

II. Perform activities with GMOs in violation of the terms and conditions set out in the respective permissions and authorizations;

III. Perform contained use activities of OGMs, without presenting the notices in the terms set forth in this Act;

IV. Perform activities with GMOs that are subject to or exempt from the notice, in violation of the other provisions of this Law, its regulations and the Mexican official rules that they are derived from that, which are applicable to the activity in question or which are common to all activities in the field of biosecurity;

V. Present to the competent Secretariats, information and/or documentation referred to in this order that is false, including that relating to the possible risks that activities with GMOs may be to cause human health or biological diversity;

VI. Incompliance with the health, monitoring, control and prevention measures identified by those interested in the information and documentation provided to obtain the respective permits and authorizations, and those established by the Secretaries in the permits and authorisations themselves;

VII. Incompliance with the emergency control and response measures identified by those interested in their studies of the possible risks that activities with GMOs may cause to health human or biological diversity or animal, plant or aquaculture health;

VIII. Incompliance with the obligation to report or make knowledge to the Secretariats, in the assumptions established in this Law;

IX. Incompliance with the obligation to adopt and implement additional biosecurity requirements and measures determined by the Secretaries, in cases of contained use activities subject to warning, in which it is determined;

X. Incompliance with the obligation to review, implement or adopt new health, monitoring, control and prevention measures, in cases where the competent Secretariats so determine provided in this Law;

XI. Perform activities with OGMs or any other body whose purpose is the manufacture and/or use of biological weapons;

XII. Make releases of GMOs in the centers of origin and genetic diversity, outside of the cases established in this Law;

XIII. Perform activities with GMOs in the protected natural areas identified in this Law, outside of the cases established by it;

XIV. Incompliance with the obligation to inform the SEMARNAT or the SAGARPA, according to its field of competence according to this Law, by means of the corresponding report, the results of the realization of experimental releases or pilot releases, which have the respective permission;

XV. Import GMOs that are prohibited in the country of origin or are classified as not permitted for commercial release or for importation for that activity on the lists refers to this Law, where the relevant Secretaries have not determined positively that these prohibitions are not applicable in the national territory;

XVI. Present the notices to the corresponding Secretaries without being signed by the person who must do so in accordance with this Law;

XVII. Do not carry and/or do not provide the corresponding Secretariat with the book of record of the activities that are carried out in contained use, in the terms established in this Law and in the rules Mexican officers who derive from it;

XVIII. Do not suspend the contained use activity in cases where the corresponding Secretaries, once the notice is presented by the person concerned, determine the situation and, where appropriate, the activity requires additional biosecurity requirements or measures to continue its performance;

XIX. Perform contained use activities by ceasing to apply the containment and treatment measures, final disposition and disposal of OGMs residues generated in the performance of the activity;

XX. Incompliance with the provisions regarding the generation, treatment, confinement, final disposal, destruction or disposal of waste from GMOs, which are laid down in the official Mexican rules arising from this order;

XXI. Do not integrate internal biosecurity commissions in cases, forms, and deadlines that establish the regulatory provisions that result from this Act;

XXII. Incompliance with the obligation to carry out the actions and measures of security or urgent application established by the competent Secretariats, in the cases and terms established in this Law;

XXIII. Incompliance with the provisions of this Law and the Mexican official rules resulting therefrom, concerning the labelling of products containing GMOs and products derived from such organisms;

XXIV. Incompliance with the provisions of this order and the Mexican official rules resulting from it, regarding the identification of OGMs;

XXV. Perform contained use activities of OGMs, other than those manifested in the notices presented in the terms of this Act;

XXVI. Perform activities with OGMs other than those allowed, or target GMOs for different purposes than allowed or authorized;

XXVII. intentionally release GMOs into the environment without the release permissions and, where applicable, the authorizations, which correspond to this Law, and

XXVIII. Release the OGMs environment that have been imported or produced in the national territory, in the terms of this Act, for direct human or animal consumption, for food processing human consumption, or for other uses other than their release to the environment.

CHAPTER II

ARTICLE 120.- Violations of the precepts of this Law, its regulations, and the Mexican official rules derived from it, as mentioned in the previous article, will be administratively sanctioned. by the competent Secretaries, with one or more of the following penalties:

I. Multa of five hundred to fifteen thousand days of general minimum wage in force in the Federal District to the one who commits the infractions foreseen in the fractions IV, V, VIII, XIV, XVI, XVII, and XXI of the article 119 of this Law;

II. Multa of fifteen thousand one to thirty thousand days of general minimum wage in force in the Federal District to the one who commits the infractions foreseen in the fractions I, II, III, VI, VII, IX, X, XI, XII, XIII, XV, XVIII, XIX, XX, XXII, XXIII, XXIV, XXV, XXVI and XXVII of Article 119 of this order.

In the case of recidivism, the amount of the corresponding fine will be doubled. For the purposes of this fraction, the offender who incurs more than once in conduct involving breaches of the same precept, within a period of two years, counted from the date on which the competent Secretariat is responsible, is deemed to be a repeat offender. determine by a final decision the commission of the first infringement, and provided that it has not been distorted;

III. Temporary or permanent closure, partial or total, of the facilities in which the infringements were committed when:

A) Violations generate potential risks or adverse effects to human health or biological diversity or animal, plant or aquaculture health;

B) The infringer has not complied with the deadlines and conditions imposed by the competent Secretaries, with the security or urgent enforcement measures ordered, or

C) It is a matter of repeated disobedience to compliance with some or some security or urgent enforcement measures imposed by the competent Secretaries;

IV. The confiscation of the instruments, copies, organisms obtained or products directly related to the violations committed;

V. The suspension or revocation of the permissions and the corresponding authorizations;

VI. Administrative Arrest for up to thirty-six hours, and

VII. Prohibition of experimental release, release in pilot program, or marketing of GMOs or products containing them.

ARTICLE 121.- Regardless of the provisions of the foregoing Article, any person who, with full knowledge of the OGMs, causes damages to third parties in his or her property, by use or The Commission will be responsible and will be required to repair them in the terms of the federal civil legislation. The same obligation shall be made by the person who damages the environment or biological diversity, by the use or improper handling of GMOs, for which the provisions of Article 203 of the General Law of Ecological Balance and Protection shall be applicable. Environment.

The persons directly affected in their property may request the judge, who requires the competent Secretariat, to ensure that, through their respective scientific technical committee, that they establish in accordance with this (a) a technical opinion designed to demonstrate the existence of the damage and to serve as a basis for the judge to determine, where appropriate, the form of his or her repair. The technical advice issued will not generate any cost from the applicants.

In the event of damage to the environment or biological diversity, SEMARNAT, through the Federal Office of Environmental Protection, will exercise the responsibility, and can do so in any case. in the following ways:

I. On its own initiative, based on the file relating to inspection and surveillance acts that have been definitively concluded, the commission of breaches of this Law has been determined and this determination is not been distorted by any means of impeachment, or

II. By complaint, filed by members of the affected community, of acts that may contravene the provisions of this Law and other provisions that emanate from it. The complaint must be accompanied by the technical and scientific information that supports it, with the participation of the Scientific Advisory Council of the CIBIOGEM, following the opinion of the National Commission for the Knowledge and Use of Biodiversity.

In the cases referred to in the previous fractions, the Federal Office of the Environmental Protection will proceed to exercise the action of responsibility based on the technical opinion that for this purpose the scientific technical committee of SEMARNAT. For the formulation of the opinion, the scientific technical committee shall evaluate the information and the elements with which the Federal Office of Protection of the Environment is responsible, either in the administrative file or those provided by the complainants, respectively, and shall determine, where appropriate, the existence of the damage. They shall be competent to know about the actions of liability for damage to the environment or biological diversity in the terms of this Article, the district courts in civil matters, in accordance with the territorial jurisdiction established in the respective provisions.

The administrative penalties provided for in the previous Article shall apply without prejudice, where appropriate, to the penalties that correspond to the acts or omissions that constitute violations of this Law. also constituting a crime in accordance with the applicable provisions of the Federal Criminal Code.

ARTICLE 122.- They are applicable to this Chapter in respect of administrative responsibilities, the provisions of the Single Chapter of Title IV of the Federal Law of Procedure Administrative, with the exception of Article 70-A of that order.

TITLE TWELFTH Review

ARTICLE 123.- The final decisions given in the administrative procedures for the application of this Law, its regulations and the rules that derive from it, may be challenged by the persons concerned by the review appeal within 15 days of the date of their notification or before the competent courts.

The review appeal shall be brought directly to the Secretariat which issued the contested decision, who, if appropriate, shall grant its admission, and the grant or refusal of the suspension of the act. used, turning the resource to its hierarchical superior in the same Secretariat for final resolution.

ARTICLE 124.- With regard to the other formalities relating to the substantiation of the review appeal referred to in the previous article, the provisions of Title VI of the Law Federal Administrative Procedure.

TRANSIENT

ARTICLE FIRST.- This Law shall enter into force within thirty working days of its publication in the Official Journal of the Federation.

ARTICLE SECOND.- The competent Secretaries shall issue and publish in the Official Journal of the Federation the formats of notices referred to in this order, within twenty days following their approval by the Federal Regulatory Improvement Commission.

ARTICLE THIRD.- Once the formats referred to in the preceding transitional article have been issued and published, the persons concerned that in accordance with this Law have the obligation to submit notices, they must do so within ninety days of the publication of such formats in the Official Journal of the Federation.

ARTICLE FOURTH.- The holders of the authorizations granted prior to the issuance of this Law shall not be affected by virtue of the entry into force of this order in the rights and obligations entered in those obligations.

ARTICLE QUINTO.- Applications for authorizations whose processing has begun prior to the issuance of this Law, and which are pending resolution, must be resolved in accordance with the legal and administrative provisions in force at the time those applications were entered.

ARTICLE SIXTH.- The SHCP shall carry out the necessary acts to transfer the necessary resources for the operation of the Executive Secretariat and the Scientific Advisory Council of the CIBIOGEM, and shall approve the places which are necessary for the functioning of the Executive Secretariat of that CIBIOGEM, with the resources approved by the said Commission, as well as those which the dependencies and entities that make up the CIBIOGEM Commission, approved for these purposes, in the terms of the applicable provisions.

The actions arising from compliance with this Law and other provisions resulting from it will be dealt with by the budgetary availability approved for this purpose. dependencies and entities of the Federal Public Administration making up the CIBIOGEM.

The Presidential Agreement establishing the CIBIOGEM will continue in force in so far as it does not object to this Law until the corresponding regulatory provisions of this Law are issued. ordering.

ARTICLE SEVENTH.- The regulatory provisions concerning the provisions of Chapter IV of Title 1 of this Law, as well as those corresponding to Chapters I and II of the Eighth Title of this same order, shall be issued within six months from the entry into force of this order. The CIBIOGEM shall issue its operating rules within 60 days of the entry into force of the regulatory provisions referred to in this Article.

ARTICLE EIGHTH.- The call to integrate the Advisory Council will be issued within thirty days of the entry into force of this Law, and will be integrated into the three months following the publication of the call.

ARTICLE NINTH.- The CONACyT will perform what is necessary to modify the trust that it has established for the management of resources of the Intersecretarial Commission created by the Presidential Agreement published in the Official Journal of the Federation on November 5, 1999, in order to comply with this Law, in order to operate in the future as the Fund for the Promotion and Support of Scientific and Technological Research in Biosafety and Biotechnology, which sets out the present order.

ARTICLE DECIMAL.- The program for the development of biosafety and biotechnology referred to in Article 29 of this Law shall be formulated and issued within a period of no more than one year. counted from the entry into force of this order.

ARTICLE FIFTEENTH.- The anteprojects of the Mexican official standards referred to in Articles 42, fraction VII, 50 fraction V, 55 fraction VII, 74, 101 and 102 of this Law, they shall be submitted to the National Advisory Committees for Standardisation and be integrated into the National Standardisation Programme within a period not longer than six months from the date of entry into force of this Regulation, in accordance with and for the purposes laid down in the Federal Law on Metrology and Standardisation.

The anteprojects of the other Mexican official rules referred to in this Law shall be filed within one year of the entry into force of this Law, for the purposes set out in the preceding paragraph.

The Mexican official norms referred to in Articles 42, fraction VII, 50 fraction V, and 55 fraction VII of this Law, the SEMARNAT and the SAGARPA, in their respective regulations are also issued. areas of their competence, may determine the information deemed necessary, with the participation that corresponds to the Federal Regulatory Improvement Commission, and within a period not exceeding one year from the entry into force of this order, in order to issue the corresponding permits.

ARTICLE TWELFTH.- All legal provisions that object to this Law are repealed.

Mexico, D. F., as at 15 February 2005.-Dip. Manlio Fabio Beltrones Rivera, President.-Sen. Diego Fernandez de Cevallos Ramos, President.-Dip. Marcos Morales Torres, Secretary.-Sen. Sara I. Castellanos Cort├ęs, Secretary.-Rubicas.

In compliance with the provisions of Article 89 (I) of the Political Constitution of the United Mexican States, and for its due publication and observance, I request this Decree in the Residence of the Federal Executive Branch, in Mexico City, Federal District, at the seventeen days of March of two thousand five.- Vicente Fox Quesada.-Heading.-The Secretary of Government, Santiago Creel Miranda.-Heading.