0A4F4F9BD490A749D5437F821CF06DF1
Biosafety Law on Genetically Modified Organisms
http://www.diputados.gob.mx/LeyesBiblio/pdf/LBOGM.pdf
http://leaux.net/URLS/ConvertAPI Text Files/AEAAC8B3B3461FFF76240D6F9E4029B1.en.txt
Examining the file media/Synopses/AEAAC8B3B3461FFF76240D6F9E4029B1.html:
This file was generated: 2020-07-14 06:13:07
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator crime:
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p.(None): accidental, to the environment and to biological diversity, in accordance with the provisions of this Law and the regulations
p.(None): Mexican officers derived from it;
p.(None): V. Participate in the preparation and issuance of the lists referred to in this Law;
p.(None): SAW. Suspend the effects of permits, when you have scientific and technical information from which it follows that
p.(None): the permitted activity involves risks higher than those expected, which may affect
p.(None): 9 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): negatively to the environment, biological diversity or human health or animal health,
p.(None): Vegetable or aquaculture These last two cases, at the express request of SAGARPA or the SSA, according to their competence
p.(None): in accordance with this Law, with support in technical and scientific elements;
p.(None): VII. Order and apply the relevant security or urgent application measures, with bases
p.(None): scientific and technical and in the precautionary approach, in the terms of this Law;
p.(None): VIII. Inspect and monitor compliance with this Law, its regulations and official Mexican standards that
p.(None): derive from it;
p.(None): IX. Impose administrative sanctions on people who violate the precepts of this Law, their
p.(None): Mexican regulations and official regulations that derive from it, without prejudice, where appropriate, of the penalties
p.(None): correspond when the acts or omissions constituting infractions to this system are also constitutive
p.(None): of crime, and of the civil and environmental responsibility that may result, and
p.(None): X. The others that this Law confers.
p.(None): ARTICLE 12.- It is the responsibility of SAGARPA to exercise the powers conferred on it by this Law, in the case of
p.(None): activities with GMOs in the following cases:
p.(None): I. Vegetables that are considered agricultural species, including seeds, and any other organism or product
p.(None): considered within the scope of the Federal Plant Health Law, with the exception of
p.(None): wild and forest species regulated by the General Wildlife Law and the General Forest Development Law
p.(None): Sustainable, respectively, and those that are under some protection regime by official standards
p.(None): Mexicans derived from these laws;
p.(None): II. Animals that are considered livestock species and any other considered within the scope of the
p.(None): Federal Animal Health Law, with the exception of wild species regulated by the General Life Law
p.(None): Wild and those that are under some protection regime by official Mexican standards
p.(None): derived from those laws;
p.(None): III. Phytozoosanitary and animal and plant nutrition inputs;
p.(None): IV. Fishing and aquaculture species, with the exception of those that are under some protection regime for
p.(None): official Mexican standards;
p.(None): V. GMOs used in immunization to protect and prevent the spread of
p.(None): animal diseases;
p.(None): SAW. GMOs that are fungi, bacteria, protozoa, viruses, viroids, spiroplasmas, phytoplasms, and others
p.(None): microorganisms, which have productive agricultural, livestock, aquaculture or phytozoosanitary purposes, and
...
p.(None): New Law DOF 03-18-2005
p.(None): III. Resolve and issue permits to carry out activities with GMOs, as well as establish and monitor
p.(None): the conditions and measures to which these activities must be subject, in accordance with the provisions of this
p.(None): ordering;
p.(None): IV. Monitor the effects that could be caused by the release of GMOs, permitted or
p.(None): accidental, to animal, plant and aquaculture health, and to biological diversity, in accordance with what they have
p.(None): this Law and the official Mexican norms that derive from it;
p.(None): V. Participate in the preparation and issuance of the lists referred to in this Law;
p.(None): SAW. Suspend the effects of permits, when you have scientific and technical information
p.(None): supervening from which it is deduced that the permitted activity entails higher risks than expected, which may
p.(None): negatively affect animal, plant or aquaculture health, biological diversity or human health. These two
p.(None): last cases, at the express request of the SEMARNAT or the SSA, depending on their competence under this Law, with
p.(None): support in technical and scientific elements;
p.(None): VII. Order and apply the relevant security or urgent application measures, with technical bases and
p.(None): scientific and in the precautionary approach, in the terms of this Law;
p.(None): VIII. Inspect and monitor compliance with this Law, its regulations and official Mexican standards that
p.(None): derive from it;
p.(None): IX. Impose administrative sanctions on people who violate the precepts of this Law, their
p.(None): Mexican regulations and official regulations that derive from it, without prejudice, where appropriate, of the penalties
p.(None): correspond when the acts or omissions constituting infractions to this system are also constitutive
p.(None): of crime, and of the civil liability that may result, and
p.(None): X. The others that this Law confers.
p.(None): ARTICLE 14.- In the cases in which SEMARNAT is responsible for the knowledge, processing and resolution of a
p.(None): permission application, in the case of wild and forest species, you must send the respective file to the
p.(None): SAGARPA to issue the corresponding opinion.
p.(None): ARTICLE 15.- In cases that fall within the competence of SAGARPA, SEMARNAT will
p.(None): The following will apply:
p.(None): I. Issue the corresponding biosafety opinion, prior to the resolution of SAGARPA, as a result of the
p.(None): analysis and evaluation of risks that you carry out based on the study developed and presented by the
p.(None): interested, about the possible risks that the activity with GMOs in question may cause to the environment and
p.(None): biological diversity, in the case of applications for permits for experimental release of said organisms, or
p.(None): based on the results reports and the information that the interested parties attach to their requests for
p.(None): permits for release in pilot program and for commercial release;
p.(None): II. Require SAGARPA to suspend the effects of the permits issued by said Secretariat, when available
p.(None): of scientific and technical information from which it is deduced that the permitted release involves risks
p.(None): higher than expected that may adversely affect the environment and biological diversity, and
p.(None): III. The exercise of the powers established in sections I, II, IV, V, VII and VIII of article 11 of this
p.(None): Law.
p.(None): 11 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
...
p.(None): granting of the corresponding permits to be issued to SAGARPA, and will be issued in the terms of article 66 of
p.(None): this law.
p.(None): ARTICLE 16.- It is the responsibility of the SSA to exercise the following powers in relation to GMOs:
p.(None): I. Participate in the formulation and implementation of the general biosafety policy;
p.(None): II. Evaluate on a case-by-case basis the studies prepared and presented by stakeholders on safety and possible
p.(None): risks of GMOs subject to authorization under the terms of Title Five of this Law;
p.(None): III. Resolve and issue the authorizations of GMOs referred to in the previous section;
p.(None): IV. Participate in the preparation and issuance of the lists referred to in this Law;
p.(None): V. Order and apply the relevant security or urgent application measures, with technical and scientific basis and
p.(None): in the precautionary approach, in the terms of this Law;
p.(None): SAW. Request from SEMARNAT or SAGARPA, as appropriate, with support from technical and scientific elements, the
p.(None): suspension of the effects of the release of GMOs to the environment, when available
p.(None): information from which it is deduced that the activity permitted by these Secretariats involves risks greater than
p.(None): expected to affect human health;
p.(None): VII. Inspect and monitor compliance with this Law, its regulations and official standards
p.(None): Mexican
p.(None): VIII. Impose administrative sanctions on people who violate the provisions of this Law, its regulations and
p.(None): Mexican official norms that derive from this Law, without prejudice, where appropriate, of the corresponding penalties when the
p.(None): acts or omissions constituting violations of this system are also constitutive of crime, and of the
p.(None): civil liability that may result, and
p.(None): IX. The others that this Law confers.
p.(None): The SSA will carry out the actions of sanitary and epidemiological surveillance of GMOs and the products that
p.(None): contain and derived products, in accordance with the General Health Law and its provisions
p.(None): Regulatory
p.(None): ARTICLE 17.- In case of accidental release of GMOs, the Secretariats will coordinate so that, within the scope of their
p.(None): respective powers in accordance with this Law, impose the necessary measures to avoid negative effects on the
p.(None): biological diversity, to human health or to animal, plant and aquaculture health, as appropriate.
p.(None): ARTICLE 18.- It corresponds to the SHCP the exercise of the following faculties, with respect to the import
p.(None): of GMOs and products containing them:
p.(None): I. Check in the customs of entry of the national territory, that the GMOs that are imported and destined for their release
p.(None): to the environment or for the purposes established in article 91 of this Law, have the permission and / or authorization
p.(None): respectively, as the case may be in the terms of this system;
p.(None): II. Check that the documentation that accompanies the GMOs that are imported into the country, contains the requirements of
p.(None): identification established in the official Mexican norms that derive from this Law;
p.(None): 12 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): III. Participate, jointly with the Secretariats, in the issuance of official Mexican standards related to
...
p.(None): established in this Law and other provisions that emanate from it. The complaint must be accompanied by the information
p.(None): technical and scientific support, with the participation of the Scientific Advisory Board of the CIBIOGEM,
p.(None): previous opinion of the National Commission for the Knowledge and Use of Biodiversity.
p.(None): In the cases referred to in the previous sections, the Federal Attorney General's Office
p.(None): Ambiente will proceed to exercise the action of responsibility based on the technical opinion that for such effect elaborates
p.(None): the scientific technical committee of the SEMARNAT. For the formulation of the opinion, the scientific technical committee will evaluate
p.(None): the information and the elements available to the Federal Attorney for Environmental Protection, whether
p.(None): that work in the administrative file or those provided by the complainants, respectively, and
p.(None): determine, where appropriate, the existence of the damage. They will be competent to know about the actions of
p.(None): liability for damage to the environment or biological diversity in the terms of this
p.(None): Article, the district courts in civil matters, in accordance with the territorial jurisdiction established in the
p.(None): respective provisions.
p.(None): The administrative sanctions established in the previous Article shall apply without prejudice, where appropriate,
p.(None): of the corresponding penalties when the acts or omissions constituting violations of this Law, are also
p.(None): constitutive of crime in accordance with the applicable provisions of the Federal Criminal Code.
p.(None): 41 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 122.- They are additionally applicable to this Chapter regarding administrative responsibilities,
p.(None): the provisions of the Single Chapter of the Fourth Title of the Federal Law of Administrative Procedure, with the exception
p.(None): of article 70-A of said system.
p.(None): TITLE TENTH
p.(None): Review Resource
p.(None): ARTICLE 123.- The final resolutions issued in the administrative procedures on the occasion of the
p.(None): application of this Law, its regulations and the rules that derive from it, may be challenged by the
p.(None): affected by the appeal for review, within fifteen days following the date of its notification, or before
p.(None): the competent jurisdictional instances.
p.(None): The appeal for review will be filed directly with the Secretariat that issued the contested decision,
p.(None): who in his case, will grant his admission, and the granting or the denial of the suspension of the act appealed, taking turns
p.(None): the recourse to your superior in the same Secretariat for final resolution.
p.(None): ARTICLE 124.- As regards the other procedures related to the substantiation of the appeal for review to
p.(None): referred to in the previous article, the provisions of Title Six of the Federal Law of
p.(None): Administrative Procedure.
p.(None): TRANSITORY
p.(None): FIRST ARTICLE.- This Law shall enter into force within thirty business days of its publication in the
...
Political / Indigenous
Searching for indicator indigenous:
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p.(None): to the environment of GMOs coming from residues of any type of processes in which they have been used
p.(None): organisms;
p.(None): XV. The application of this Law, administrative procedures and criteria for the evaluation of possible
p.(None): risks that could be generated by the activities regulated by this Law, the control instruments of said activities, the
p.(None): monitoring of them, their regulations and the official Mexican norms that derive from it, the procedures of
p.(None): inspection and surveillance to verify and verify compliance with this Law and the provisions that
p.(None): they derive, the implementation of security measures and urgent application, and the application of
p.(None): sanctions for violations of the precepts of this Law and the provisions that emanate from it, are the form
p.(None): in which the Mexican State acts with caution, prudently and with scientific and technical bases to prevent,
p.(None): reduce or avoid the possible risks that activities with GMOs could cause to human health or to
p.(None): environment and biological diversity;
p.(None): 8 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): XVI. The biosecurity of agricultural, fishery and aquaculture products is
p.(None): closely related to plant, animal and aquaculture health, so the policy in these
p.(None): subjects should include environmental, biological diversity, human health and plant health aspects and
p.(None): animal;
p.(None): XVII The Mexican State will cooperate in the area of information exchange and research on the effects
p.(None): socioeconomic status of GMOs, especially in indigenous and local communities;
p.(None): XVIII. The Mexican State will guarantee public access to biosafety and biotechnology information to
p.(None): referred to in this Law, in accordance with the provisions of this system and the provisions applicable to the
p.(None): matter of access to government public information, and
p.(None): XIX. Experimentation with GMOs or with any other body for manufacturing and / or use purposes
p.(None): of biological weapons is prohibited in the national territory.
p.(None): CHAPTER III
p.(None): Of the Biosafety Competencies
p.(None): ARTICLE 10.- Are competent authorities in the field of biosafety:
p.(None): I. The SEMARNAT;
p.(None): II. SAGARPA, and
p.(None): III. SSA
p.(None): The SHCP will have the powers established in this Law, regarding the import of GMOs and
p.(None): of products that contain them.
p.(None): ARTICLE 11.- It corresponds to the SEMARNAT the exercise of the following faculties regarding activities with all types
p.(None): of GMOs, except in the case of GMOs that correspond to SAGARPA:
p.(None): I. Participate in the formulation and implementation of the general biosafety policy;
p.(None): II. Analyze and evaluate on a case-by-case basis the possible risks that activities with GMOs could
p.(None): cause the environment and biological diversity, based on risk studies and reports of
p.(None): results elaborated and presented by the interested parties, in the terms of this Law;
p.(None): III. Resolve and issue permits for carrying out activities for the release of GMOs into the environment, as well as
p.(None): establish and follow up on the conditions and measures to which these activities must be subject, according to
...
p.(None): SAW. The capacity and form of propagation of genetically modified organisms;
p.(None): VII. The existence of wild relatives in any area or region of the national territory that is its center
p.(None): originally;
p.(None): VIII. The scale or volume of handling, and
p.(None): IX. The possible effects or risks that the different activities with these organisms could cause to the
p.(None): environment and biological diversity or human health or animal, plant or aquaculture health.
p.(None): EIGHTH TITLE
p.(None): About Biosafety Information
p.(None): CHAPTER I
p.(None): From the National Biosafety Information System
p.(None): ARTICLE 108.- The CIBIOGEM, through its Executive Secretariat, will develop the National Information System on
p.(None): Biosafety that will aim to organize, update and disseminate information on biosafety. In said
p.(None): System, CIBIOGEM must integrate, among other aspects, the information corresponding to the Registry.
p.(None): The CIBIOGEM will gather relevant reports and documents resulting from scientific, academic, work activities
p.(None): technicians or any other type of biosafety, including the safety of GMOs, carried out
p.(None): by natural or legal persons, national or foreign, who will be referred and organized by the National System
p.(None): Information on Biosafety. In addition, it will prepare and publish annually a detailed report of the situation
p.(None): general existing in the country regarding biotechnology and biosafety subject of this Law.
p.(None): The CIBIOGEM will also carry out the studies and socio-economic considerations resulting from the effects of the
p.(None): GMOs that are released to the environment in the national territory, and will establish the mechanisms to carry out the
p.(None): consultation and participation of indigenous peoples and communities settled in areas where liberation is sought
p.(None): of GMOs, considering the value of biological diversity.
p.(None): 34 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): Likewise, the CIBIOGEM Executive Secretariat will serve as the National Focal Center before the Secretariat
p.(None): of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity,
p.(None): being responsible for liaising with said Secretariat and for complying with the provisions of Article 19 of
p.(None): said International Treaty. The CIBIOGEM Executive Secretariat will also be responsible for providing
p.(None): Biosafety Information Exchange Center established in the aforementioned Protocol,
p.(None): any information about:
p.(None): I. Existing national laws, regulations and guidelines for the application of the Protocol, as well as information and
p.(None): documentation required, in terms of this Law, for the administrative permit procedure
p.(None): of import of GMOs to be released experimentally, in pilot program or commercially;
p.(None): II. Bilateral, regional and multilateral agreements and arrangements;
p.(None): III. Summaries of GMO risk assessments, as well as relevant product information
p.(None): GMO derivatives;
p.(None): IV. Final resolutions on the importation or release into the environment of GMOs, as well as the modification
p.(None): of resolutions derived from its revision in accordance with this Law;
p.(None): V. The socioeconomic effects of GMOs, especially in indigenous and local communities, and
p.(None): SAW. Reports on compliance with the obligations established in the Protocol, including those relating to the
p.(None): application of the procedure for importing GMOs to be released into the environment experimentally, in program
p.(None): pilot or commercial
p.(None): The competent Secretariats may provide directly to the Information Exchange Center
p.(None): on Biosafety, the information referred to in the previous sections, informing
p.(None): simultaneously to the Executive Secretariat of the CIBIOGEM.
p.(None): CHAPTER II
p.(None): From the National Biosafety Registry of GMOs
p.(None): ARTICLE 109.- The Registry, which will be in charge of the CIBIOGEM Executive Secretariat, will be public and
p.(None): Its purpose is to register information related to activities with GMOs, as well as their own
p.(None): organisms. Its operation and what may be subject to registration will be determined in the provisions
p.(None): regulations that derive from this Law. SEMARNAT, SAGARPA and SSA will contribute to the organization and
p.(None): Registry operation.
p.(None): NINTH TITLE
p.(None): Of the Official Mexican Standards in Biosafety
p.(None): ARTICLE 110.- To guarantee the biosecurity of activities with GMOs, the Secretariats, jointly or
p.(None): with the participation of other agencies of the Federal Public Administration, they will issue regulations
p.(None): Mexican officials whose purpose is to establish guidelines, criteria, technical specifications
p.(None): and procedures in accordance with the provisions of this Law.
p.(None): ARTICLE 111.- In the formulation of official Mexican standards regarding biosafety, it should be considered that the
p.(None): compliance with its forecasts must be carried out in accordance with the characteristics of each activity or
p.(None): production process with GMOs.
p.(None): 35 of 44
...
Searching for indicator native:
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p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 86.- The species of which the United Mexican States is a center of origin and genetic diversity as well
p.(None): as the geographical areas in which they are located, will be determined jointly through agreements by the
p.(None): SEMARNAT and SAGARPA, based on the information they have in their files or in their databases,
p.(None): including the one that provides, among others, the National Institute of Statistics, Geography and Informatics,
p.(None): the National Institute of Forestry, Agricultural and Livestock Research, the National Institute of
p.(None): Ecology, the National Commission for the Knowledge and Use of Biodiversity and the National Commission
p.(None): Forestry, as well as international agreements and treaties related to these matters. SEMARNAT and SAGARPA
p.(None): they will establish in the agreements that issue, the necessary measures for the protection of said
p.(None): species and geographic areas.
p.(None): ARTICLE 87.- For the determination of the centers of origin and genetic diversity, the
p.(None): following criteria:
p.(None): I. That they are considered centers of genetic diversity, understanding by them the regions that currently
p.(None): they host populations of the wild relatives of the GMO in question, including different races or
p.(None): varieties thereof, which constitute a genetic reserve of the material, and
p.(None): II. In the case of crops, the geographical regions where the organism in question was
p.(None): domesticated, as long as these regions are centers of genetic diversity.
p.(None): ARTICLE 88.- In the centers of origin and genetic diversity of animal and plant species only allowed
p.(None): the release of GMOs in the case of GMOs other than native species, always
p.(None): that their release does not cause a negative impact on human health or biological diversity.
p.(None): CHAPTER II
p.(None): Of the Activities with GMOs in Protected Natural Areas
p.(None): ARTICLE 89.- In the protected natural areas created in accordance with the provisions of the matter,
p.(None): only activities with GMOs will be allowed for bioremediation purposes, in cases where pests appear or
p.(None): pollutants that could endanger the existence of animal, vegetable or aquaculture species, and
p.(None): GMOs have been created to avoid or combat this situation, provided that the scientific elements and
p.(None): necessary technicians who support the environmental benefit that is intended to be obtained, and such activities are allowed
p.(None): by SEMARNAT in the terms of this Law.
p.(None): For the purposes of the provisions of the preceding paragraph, it is prohibited to carry out activities with GMOs in the areas
p.(None): core of protected natural areas.
p.(None): In the event that any center of origin or center of genetic diversity is located within a natural area
p.(None): protected, the declarations of creation and the management programs of these areas will be modified in the
p.(None): terms of the legislation of the matter, as the determinations referred to in Article 86 of
p.(None): This Law
p.(None): CHAPTER III
p.(None): GMO Free Zones
p.(None): ARTICLE 90.- GMO-free zones may be established for the protection of agricultural products
p.(None): organic and others of interest to the requesting community, in accordance with the following general guidelines:
p.(None): 29 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
...
p.(None): Specific conditions.
p.(None): ARTICLE 105.- The list of GMOs that have authorization will be prepared and issued by the SSA, considering the
p.(None): Results of the case-by-case evaluation of the possible risks of these health agencies
p.(None): human, and will be published for knowledge and dissemination in the Official Gazette of the Federation. Its purposes will be
p.(None): indicate the legal situation in which these GMOs are, and determine the cases in which the
p.(None): GMOs authorized under this Law may be marketed and imported.
p.(None): ARTICLE 106.- The list of GMOs to carry out activities of confined use of said organisms
p.(None): for teaching and scientific and technological research purposes it will be issued jointly
p.(None): by the Secretariats, and will be published for their knowledge and dissemination in the Official Gazette of the Federation.
p.(None): 33 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 107.- In the formulation, issuance and modification of the GMO information lists, the following shall be observed.
p.(None): that is established in the regulatory provisions that derive from this ordinance,
p.(None): taking into account the following guidelines:
p.(None): They will be formulated according to:
p.(None): I. The nature of the genetically modified organism;
p.(None): II. The presence in the country or region of interest, of sexually compatible species with the organism genetically
p.(None): modified;
p.(None): III. The type of sexual reproduction of the genetically modified organism and native species
p.(None): sexually compatible;
p.(None): IV. The nature of the receiving or parental organism;
p.(None): V. The characteristics of the vector and the insert of genetic material used in the operation;
p.(None): SAW. The capacity and form of propagation of genetically modified organisms;
p.(None): VII. The existence of wild relatives in any area or region of the national territory that is its center
p.(None): originally;
p.(None): VIII. The scale or volume of handling, and
p.(None): IX. The possible effects or risks that the different activities with these organisms could cause to the
p.(None): environment and biological diversity or human health or animal, plant or aquaculture health.
p.(None): EIGHTH TITLE
p.(None): About Biosafety Information
p.(None): CHAPTER I
p.(None): From the National Biosafety Information System
p.(None): ARTICLE 108.- The CIBIOGEM, through its Executive Secretariat, will develop the National Information System on
p.(None): Biosafety that will aim to organize, update and disseminate information on biosafety. In said
p.(None): System, CIBIOGEM must integrate, among other aspects, the information corresponding to the Registry.
p.(None): The CIBIOGEM will gather relevant reports and documents resulting from scientific, academic, work activities
p.(None): technicians or any other type of biosafety, including the safety of GMOs, carried out
p.(None): by natural or legal persons, national or foreign, who will be referred and organized by the National System
p.(None): Information on Biosafety. In addition, it will prepare and publish annually a detailed report of the situation
p.(None): general existing in the country regarding biotechnology and biosafety subject of this Law.
p.(None): The CIBIOGEM will also carry out the studies and socio-economic considerations resulting from the effects of the
...
Political / criminal
Searching for indicator criminal:
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p.(None): technical and scientific support, with the participation of the Scientific Advisory Board of the CIBIOGEM,
p.(None): previous opinion of the National Commission for the Knowledge and Use of Biodiversity.
p.(None): In the cases referred to in the previous sections, the Federal Attorney General's Office
p.(None): Ambiente will proceed to exercise the action of responsibility based on the technical opinion that for such effect elaborates
p.(None): the scientific technical committee of the SEMARNAT. For the formulation of the opinion, the scientific technical committee will evaluate
p.(None): the information and the elements available to the Federal Attorney for Environmental Protection, whether
p.(None): that work in the administrative file or those provided by the complainants, respectively, and
p.(None): determine, where appropriate, the existence of the damage. They will be competent to know about the actions of
p.(None): liability for damage to the environment or biological diversity in the terms of this
p.(None): Article, the district courts in civil matters, in accordance with the territorial jurisdiction established in the
p.(None): respective provisions.
p.(None): The administrative sanctions established in the previous Article shall apply without prejudice, where appropriate,
p.(None): of the corresponding penalties when the acts or omissions constituting violations of this Law, are also
p.(None): constitutive of crime in accordance with the applicable provisions of the Federal Criminal Code.
p.(None): 41 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 122.- They are additionally applicable to this Chapter regarding administrative responsibilities,
p.(None): the provisions of the Single Chapter of the Fourth Title of the Federal Law of Administrative Procedure, with the exception
p.(None): of article 70-A of said system.
p.(None): TITLE TENTH
p.(None): Review Resource
p.(None): ARTICLE 123.- The final resolutions issued in the administrative procedures on the occasion of the
p.(None): application of this Law, its regulations and the rules that derive from it, may be challenged by the
p.(None): affected by the appeal for review, within fifteen days following the date of its notification, or before
p.(None): the competent jurisdictional instances.
p.(None): The appeal for review will be filed directly with the Secretariat that issued the contested decision,
p.(None): who in his case, will grant his admission, and the granting or the denial of the suspension of the act appealed, taking turns
p.(None): the recourse to your superior in the same Secretariat for final resolution.
p.(None): ARTICLE 124.- As regards the other procedures related to the substantiation of the appeal for review to
p.(None): referred to in the previous article, the provisions of Title Six of the Federal Law of
p.(None): Administrative Procedure.
p.(None): TRANSITORY
p.(None): FIRST ARTICLE.- This Law shall enter into force within thirty business days of its publication in the
p.(None): Official Journal of the Federation.
...
Political / political affiliation
Searching for indicator party:
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p.(None): ARTICLE 6.- The following are excluded from the scope of this Law:
p.(None): I. Activities of confined use, experimental release, pilot program release and
p.(None): Commercial release, commercialization, import and export of GMOs, when the genetic modification of
p.(None): such organisms are obtained by traditional mutagenesis or cell fusion techniques, including protoplasts
p.(None): of plant cells, in which the resulting organisms can also be produced by traditional methods
p.(None): of multiplication or culture in vivo or in vitro, provided that these techniques do not involve the use of
p.(None): genetically modified organisms such as receptor or parental organisms;
p.(None): II. The use of in vitro fertilization techniques, conjugation, transduction, transformation or
p.(None): any other natural process and polyploid induction, provided that no acid molecules are used
p.(None): recombinant deoxyribonucleic (DNA) or genetically modified organisms;
p.(None): III. The production and process of medicines and drugs with GMOs generated from confined processes whose
p.(None): regulation corresponds to the General Health Law;
p.(None): IV. The sanitary control of derived products and the confined production processes in which GMOs intervene
p.(None): authorized under this Law, for human or animal use or consumption, which are subject to the provisions of
p.(None): the General Health Law and its regulations applicable to all products and processes;
p.(None): V. The human genome, the culture of stem cells of humans, the modification of human germ cells and
p.(None): the biosafety of hospitals, whose regulation corresponds to the General Health Law, and to the International Treaties
p.(None): in which the United Mexican States are a party;
p.(None): SAW. The collection and use of biological resources, whose regulation corresponds to the General Law
p.(None): of Ecological Balance and Protection of the Environment, the General Wildlife Law, and the Treaties
p.(None): Internationals in which the United Mexican States are a party, and
p.(None): VII. The intellectual property of biotechnological products and processes, which is the subject of the Property Law
p.(None): Industrial, Federal Law on Plant Varieties and International Treaties in which the United States
p.(None): Mexicans be part.
p.(None): ARTICLE 7.- The activities, organizations and products subject to the scope of this Law, will not require, in matters of
p.(None): biosecurity and safety, of other permits, authorizations, notices and, in general, requirements, procedures and
p.(None): restrictions than those established in this system.
p.(None): It is excepted from the provisions of the preceding paragraph:
p.(None): I. The measures that in the matter of general health correspond to adopt to the Secretariat of Health in the terms of
p.(None): the General Health Law and its regulations, except for the processing and issuance of
p.(None): authorizations regulated by this Law;
p.(None): II. The measures that in the matter of animal, vegetable and aquaculture health correspond to adopt to the Secretariat
p.(None): of Agriculture, Livestock, Rural Development, Fisheries and Food, under the terms of the Federal Health Law
p.(None): Animal, the Federal Plant Health Law, the Fishing Law, the Sustainable Rural Development Law, and
p.(None): of the other applicable provisions, and
p.(None): 6 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): III. The corresponding environmental measures to adopt to the Ministry of Environment and Natural Resources
...
p.(None): of Administrative Procedure.
p.(None): CHAPTER II
p.(None): Principles in Biosafety
p.(None): ARTICLE 9.- For the formulation and conduct of the biosafety policy and the issuance of regulations and
p.(None): of the official Mexican norms that derive from this Law, the following principles will be observed:
p.(None): I. The Mexican Nation has a biodiversity of the largest in the world, and its territory is
p.(None): find areas that are the center of origin and genetic diversity of species and varieties that must be
p.(None): protected, used, empowered and sustainably exploited, for being a valuable reservoir of wealth in
p.(None): molecules and genes for the sustainable development of the country;
p.(None): II. The State has the obligation to guarantee the right of every person to live in an environment suitable for
p.(None): their food, health, development and well-being;
p.(None): III. The biosecurity of GMOs aims to ensure an adequate level of protection in the area of
p.(None): Confined use, experimental release, pilot program release, commercial release,
p.(None): commercialization, importation and exportation of said organisms resulting from biotechnology
p.(None): modern that may have adverse effects for the conservation and sustainable use of the environment and the
p.(None): biological diversity, as well as human health and animal, plant and aquaculture health;
p.(None): IV. In order to protect the environment and biological diversity, the Mexican State must
p.(None): apply the precautionary approach according to their abilities, taking into account the commitments
p.(None): established in international treaties and agreements to which the United Mexican States are a party.
p.(None): When there is a danger of serious or irreversible damage, the lack of absolute scientific certainty should not be used as
p.(None): reason to postpone the adoption of cost-effective measures to prevent degradation
p.(None): of the environment and biological diversity. Such measures shall be adopted in accordance with the provisions and
p.(None): administrative procedures established in this Law;
p.(None): V. The protection of human health, the environment and biological diversity requires that attention be paid
p.(None): due to the control and management of the possible risks derived from the activities with GMOs, through an evaluation
p.(None): prior to said risks and the post-release monitoring;
p.(None): SAW. The knowledge, opinions and experience of scientists, particularly those of the country, constitute a
p.(None): valuable element of guidance for the regulation and administration of activities
p.(None): 7 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): with GMOs they are based on scientifically based studies and opinions, so it should be encouraged
p.(None): scientific research and technological development in biosafety and biotechnology;
p.(None): VII. In the confined use of GMOs for teaching, scientific research and
p.(None): technological, industrial and commercial, the provisions of this Law, its
p.(None): Mexican regulations and official norms that derive from it, as well as the norms and principles of prevention that
p.(None): establish the institutions, centers or companies, whether public or private, that carry out these activities;
...
p.(None): IV. Support to public research centers;
p.(None): V. Scientific research projects and solution-oriented innovation and technological development
p.(None): of national problems and activities that benefit the agricultural producers,
p.(None): forestry and aquaculture of the country;
p.(None): 16 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): SAW. New research and technology transfer centers in primary areas of national development, of
p.(None): according to local or regional needs for environmental conservation and protection or forestry production,
p.(None): agricultural and industrial;
p.(None): VII. Dissemination of scientific and technological knowledge;
p.(None): VIII. National and international collaboration;
p.(None): IX. Strengthening the biosafety culture, and
p.(None): X. Decentralization and regional development.
p.(None): The Federal Executive, through the competent Secretariats, will make sure to make available to
p.(None): the seed companies of farmers 'and producers' organizations, preferably and
p.(None): accessible, the results of scientific research and innovation and technological development contained in the
p.(None): Program for the development of biosafety and biotechnology.
p.(None): ARTICLE 31.- CONACyT will constitute a Fund for the Promotion and Support of Scientific Research and
p.(None): Technology in Biosafety and Biotechnology in accordance with the Law of Science and Technology, to which the
p.(None): fiscal resources provided by the agencies and entities for this purpose, third party resources and income that
p.(None): The concept of rights determines the tax provisions, which derive from acts carried out in application of this Law.
p.(None): SECOND TITLE
p.(None): Permissions
p.(None): CHAPTER I
p.(None): Common Provisions
p.(None): ARTICLE 32.- The following activities will be required for permission:
p.(None): I. The experimental release into the environment, including the importation for that activity, of one or more GMOs;
p.(None): II. The release into the environment in a pilot program, including the import for that activity, of GMOs,
p.(None): Y
p.(None): III. The commercial release to the environment, including the import for that activity, of GMOs.
p.(None): ARTICLE 33.- Once the corresponding Secretariats receive a request for permission to release to the environment
p.(None): of GMOs, and as long as it complies with the information and requirements established in this Law, they must
p.(None): send it to the Registry for their respective registration and publicity. Once the above is done, the Secretariat
p.(None): to which it corresponds to resolve the request for the release of GMOs to the environment, will put
p.(None): public provision of said request, for public consultation, and must observe the forecasts on
p.(None): confidentiality established in this Law. Said Secretariat may make use of the means it deems
p.(None): suitable for the purpose of making the respective permit application available to the public.
p.(None): Any person, including the governments of the federal entities in which it is intended to carry out the
p.(None): respective release, may express their opinion, which must be supported by technical and
p.(None): 17 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): scientifically, within a period of no more than twenty business days from the date on which the
p.(None): respective request be made available to the public in the terms of this article.
p.(None): Opinions that are issued in accordance with the provisions of the preceding paragraph will be considered
p.(None): by the corresponding Secretariats for the establishment of additional biosecurity measures, in case
p.(None): it is appropriate to issue the release of GMOs to the corresponding environment, in the terms of this Law.
p.(None): ARTICLE 34.- The corresponding Secretariat shall issue its resolution, duly founded and motivated, once
p.(None): analyzed the information and documentation provided by the interested party, the opinion or opinion they had issued
p.(None): the Secretariats that are responsible for issuing them in accordance with this Law and, where appropriate, the
p.(None): GMO authorization issued by the SSA under the terms of this system. The corresponding Secretariat
p.(None): in its resolution you can:
p.(None): I. Issuing the permit for carrying out the release activity to the environment in question,
p.(None): being able to establish additional monitoring, control, prevention and security measures to those proposed by
p.(None): the interested party in the permit application, or
p.(None): II. Deny permission in the following cases:
p.(None): A) When the request does not comply with the provisions of this Law or the official Mexican regulations such as
p.(None): requirements for the granting of the permit;
p.(None): B) When the information provided by the interested party, including that related to the possible risks that could
p.(None): cause GMOs to be false, incomplete or insufficient, or
p.(None): C) When the corresponding Secretariat concludes that the risks that may be presented by the GMOs in question,
p.(None): negatively affect human health or biological diversity, or animal, plant or aquaculture health,
p.(None): may cause serious or irreversible damage.
p.(None): ARTICLE 35.- The deadlines established in this Law for the resolution of a request for a release permit at
p.(None): GMO environment, whether experimental or pilot program, will be extendable, in case the interested party does not count
p.(None): with the authorization issued by the SSA in the terms of this ordinance, as long as said
p.(None): authorization is required for the issuance of the respective permit.
p.(None): ARTICLE 36.- The permits for experimental release, in the pilot or commercial program of GMOs to the environment, will be supplied
p.(None): effects of import permits of said organisms to be released experimentally, in
p.(None): pilot or commercial program, as the case may be, under the terms and conditions established in the own
p.(None): permissions The foregoing, notwithstanding that the import of the GMOs in question, is subject to the regime
p.(None): phytosanitary or aquaculture established in the corresponding legislation of the matter.
p.(None): ARTICLE 37.- The monitoring, prevention, control and safety measures of the possible risks of using the
p.(None): GMO established by the corresponding Secretariat in the permits, may include, among others, the following
p.(None): aspects:
p.(None): I. Management of the GMO;
p.(None): II. Safety measures so that the possible risk remains within the tolerance limits accepted in the
p.(None): evaluation, and
p.(None): 18 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): III. Monitoring of the activity in question, in relation to the possible risks that such activity could
p.(None): generate.
p.(None): ARTICLE 38.- The Secretariat that issues the permit may modify the monitoring, control and
p.(None): prevention, require the interested party to implement new measures, as well as suspend or revoke said permit,
p.(None): prior hearing granted to interested parties, when available scientific or technical information of the
p.(None): It follows that the activity may involve higher or lower risks than originally provided for
p.(None): the corresponding studies. The foregoing must be established in the permits issued by the Secretariats
p.(None): competent.
p.(None): ARTICLE 39.- The permit holder shall be obliged to observe and comply with the monitoring, prevention,
p.(None): control and security established by the permit, as well as the provisions of this system, its
p.(None): Mexican regulations and official norms that derive from it, that are applicable to the release
p.(None): concerned. Failure to comply with the measures and provisions referred to in this article will give
p.(None): place for the determination of the respective responsibility and the application of the corresponding sanctions according
p.(None): this law.
p.(None): ARTICLE 40.- The importation of GMOs or products containing them into the territory will not be allowed
p.(None): national, in cases where such organizations are prohibited in the country of origin or are found
p.(None): classified in the lists as not allowed for commercial release or for importation for that
p.(None): exercise.
p.(None): ARTICLE 41.- It is prohibited to carry out activities with GMOs or with any other body whose purpose is
p.(None): the manufacture and / or use of biological weapons.
p.(None): CHAPTER II
p.(None): Requirements for Obtaining Permits
p.(None): SECTION I
p.(None): Permission for experimental release to the environment
p.(None): ARTICLE 42.- The application for permission to perform the experimental release to the environment of GMOs,
p.(None): including its importation for that activity, it must be accompanied by the following information:
...
p.(None): II. The identification of the area where the GMO is intended to be experimentally released, including the specification of
p.(None): the total area on which the release will take place;
p.(None): III. A study of the possible risks that the release of GMOs could generate to the environment
p.(None): and to biological diversity. In addition, in cases that fall within the competence of SAGARPA, the study must
p.(None): contain what is related to the possible risks that the release of these organisms could cause to the
p.(None): animal, vegetable or aquaculture health;
p.(None): IV. The measures and procedures for monitoring activity and biosafety, which will be carried out at the time of
p.(None): carry it out and post-release ones;
p.(None): V. Where appropriate, the history of release of the GMOs concerned in other countries;
p.(None): 19 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): SAW. Where appropriate, considerations on the risks of the technological alternatives that are available will be presented.
p.(None): to contend with the problem for which the genetically modified organism that is intended to be released was constructed,
p.(None): Y
p.(None): VII. The information that for each case determines the official Mexican norms that derive from this Law.
p.(None): It will be a requirement to obtain the experimental release permit to the environment, which the applicant has
p.(None): with the authorization of the GMO issued by the SSA in accordance with this Law, when said agency has
p.(None): Public health purposes or be destined to bioremediation. The interested party may start the process
p.(None): to obtain such permission before the competent Secretariat, but it will not be granted until it is accredited in the
p.(None): respective file have obtained the authorization of the SSA.
p.(None): ARTICLE 43.- Those interested in importing GMOs for experimental release into the environment, in addition to the
p.(None): established in the previous article, they must attach to their request the information and documentation that
p.(None): prove that the GMO is allowed under the legislation of the country of origin, for its release, at least, in
p.(None): experimental stage, attaching for this purpose the authorization or official documentation that covers said
p.(None): situation.
p.(None): ARTICLE 44.- The resolution to a request for permission for experimental release of GMOs shall be
p.(None): be issued within a maximum period of six months from the day following that in which the Secretariat must
p.(None): To resolve has received the permit application and the information provided by the interested party is complete.
p.(None): ARTICLE 45.- In the event that, after the granting of the permit, in the realization of the release
p.(None): Experimental of a GMO into the environment the following is presented:
p.(None): I. There is any modification in the release that may increase or decrease the possible risks to the
p.(None): environment and biological diversity, or
p.(None): II. New scientific and technical information on these risks is available.
p.(None): In these cases, the permit holder will be obliged to:
p.(None): A. Inform the corresponding Secretariat immediately of this situation;
p.(None): B. Review the monitoring and biosafety measures specified in the documentation, and
p.(None): C. Adopt the necessary biosafety measures.
p.(None): ARTICLE 46.- The holder of the experimental release permit to the environment must inform the
p.(None): Secretariat that issued it, through a report, the results of the release (s) made in
p.(None): relationship with the possible risks to the environment and biological diversity. The characteristics and content of
p.(None): The report referred to in this article will be established in the official Mexican regulations derived from this Law.
p.(None): ARTICLE 47.- The permit holder shall be obliged to inform the Secretariat immediately.
p.(None): corresponding, any situation that in the realization of the permitted release, could increase or decrease
p.(None): the possible risks to the environment, biological diversity and / or human health.
p.(None): ARTICLE 48.- The corresponding Secretariat may limit the validity of the release permit.
p.(None): Experimental to the environment considering the elements of the file.
p.(None): 20 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
...
p.(None): ARTICLE 50.- The application for permission to release GMOs into the environment in a pilot program, including
p.(None): its import for that activity, must be accompanied by the following information:
p.(None): I. The permission for the experimental release of the GMO in question;
p.(None): II. Reference and considerations on the report of the results of the release (s)
p.(None): Experimental carried out in relation to the possible risks to the environment and biological diversity
p.(None): and, additionally, to animal, plant or aquaculture health in cases that fall within the competence of SAGARPA in accordance with
p.(None): this law;
p.(None): III. Information related to:
p.(None): A) The total amount of the GMO to be released;
p.(None): B) The driving conditions that will be given to the GMO, and
p.(None): C) Identification of the areas where the GMO is intended to be released, including the specification of the surface or
p.(None): total areas on which the release will take place.
p.(None): IV. The monitoring and biosafety measures to be carried out during the release and after said activity, and
p.(None): V. The information that for each case determines the official Mexican norms that derive from this Law.
p.(None): The foregoing, in order that the corresponding Secretariats have the information to carry out the
p.(None): analysis and evaluation of possible risks to the environment and biological diversity or to animal health,
p.(None): vegetable or aquaculture, as appropriate according to this Law.
p.(None): It will be a requirement to obtain the permit for release to the environment in a pilot program, that the applicant has the
p.(None): authorization of the GMO issued by the SSA in accordance with this Law, when said agency is for use
p.(None): or human consumption The interested party may initiate the process to obtain said permission from the Secretariat
p.(None): competent, but will not be granted until you prove in the respective file to have obtained the
p.(None): SSA authorization.
p.(None): ARTICLE 51.- Those interested in importing GMOs for their release into the pilot program environment, in addition to the
p.(None): established in the previous article, they must attach to their request the information and documentation that
p.(None): prove that the GMO is allowed under the legislation of the country of origin, for its release, at least, in
p.(None): this stage class, attaching for that purpose the authorization or official documentation that covers said
p.(None): situation.
p.(None): ARTICLE 52.- The resolution to a request for permission to release GMOs into the pilot program
p.(None): must be issued within a maximum period of three months from the day following
p.(None): 21 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): the one in which the Secretariat to resolve has received the permit application and information
p.(None): provided by the interested party is complete.
p.(None): The validity of the permit will be determined considering the elements of the file.
p.(None): ARTICLE 53.- The holder of the permit for release to the environment in a pilot program must inform the Secretariat that
p.(None): it was issued by means of a report, the results of the release (s) made in relation to the possible
p.(None): risks to the environment and biological diversity. The characteristics and content of the report referred to
p.(None): This article will be established in the official Mexican norms that derive from this Law.
p.(None): ARTICLE 54.- The permit holder shall be obliged to immediately inform the Secretariat
p.(None): corresponding, any situation that in the realization of the permitted release, could increase or decrease
p.(None): the possible risks to the environment, biological diversity and / or human health.
p.(None): SECTION III
p.(None): Permission for commercial release to the environment
p.(None): ARTICLE 55.- The application for permission to carry out the commercial release to the environment of GMOs, including their
p.(None): import for that activity, must be accompanied by the following information:
p.(None): I. Permits for experimental and pilot program release of the GMO in question;
p.(None): II. Reference and considerations on the reports of the results of the experimental release and the release in
p.(None): pilot program that has been carried out, in terms of the permits referred to in the previous section;
p.(None): III. Specific instructions or recommendations for storage, transport and, where appropriate, handling;
p.(None): IV. Where applicable, conditions for release and commercialization;
p.(None): V. Where appropriate, considerations on the risks of the technological alternatives that are available will be presented
p.(None): to contend with the problem for which the GMO that was intended to be released was built;
...
p.(None): probability that the possible risks and consequences identified actually occur, and
p.(None): V. The recommendation as to whether the possible risks are acceptable or manageable, or are not, including
p.(None): the determination of strategies for managing these possible risks.
p.(None): ARTICLE 63.- When there is uncertainty about the level of the possible risk that GMOs may cause to the
p.(None): biological diversity, the corresponding Secretariats will request within the administrative procedure of
p.(None): permission for the release of GMOs into the environment, additional information on issues
p.(None): specific risk study or will adopt appropriate strategies for risk management and / or monitoring of
p.(None): GMO in the receiving environment.
p.(None): In case of danger of serious or irreversible damage, uncertainty about the level of possible
p.(None): risks that GMOs can cause to biological diversity or human health, should not be used as a reason
p.(None): so that the corresponding Secretariat postpones the adoption of effective measures that prevent the affectation
p.(None): negative biological diversity or human health. In the adoption of such measures, the Secretariat
p.(None): corresponding will take into account the existing scientific evidence that serves as the basis or criteria for the
p.(None): establishment of the measure or measures; the administrative procedures established in this Law, and the regulations
p.(None): commercial contained in international treaties and agreements to which the United Mexican States are a party.
p.(None): ARTICLE 64.- The interested party may submit additionally to the study of possible risks, other studies or
p.(None): considerations that analyze both the contribution of the GMO to the solution of environmental, social problems,
p.(None): productive or otherwise, the socioeconomic considerations that exist regarding the release of GMOs
p.(None): to the environment, as an assessment of the risks of alternative technology options to contend with the
p.(None): specific problem for which the GMO was designed. These analyzes should be supported by
p.(None): scientific and technical evidence, in the background on use, production and consumption, and may be
p.(None): considered by the competent Secretariats as additional elements to decide on the release
p.(None): experimental to the environment, and consequent releases to the environment in pilot and commercial program, respectively,
p.(None): of the GMO in question.
p.(None): ARTICLE 65.- The characteristics and requirements of the studies to evaluate the possible risks shall be established.
p.(None): in the official Mexican norms that derive from this Law.
p.(None): CHAPTER IV
p.(None): Of the opinions
p.(None): ARTICLE 66.- The opinions that the SEMARNAT must issue will only be required in the case of
p.(None): experimental release activities, pilot program release and commercial release of GMOs
p.(None): that are the responsibility of SAGARPA. These opinions must be issued within a period of sixty days from
p.(None): after SEMARNAT receives the administrative file sent by SAGARPA. This term includes
p.(None): both the issuance of the corresponding opinion, and its referral to SAGARPA. SAGARPA will issue the permit of
p.(None): release of GMOs to the appropriate environment, provided that the opinion issued by SEMARNAT is favorable.
p.(None): 24 of 44
...
p.(None): and may be promoted by interested parties regardless of whether they enforce the means of challenge established in
p.(None): This Law against the resolution that affects them.
p.(None): CHAPTER VI
p.(None): From the Permit Review
p.(None): ARTICLE 69.- The corresponding Secretariat, at any time and on the basis of new information
p.(None): scientific or technical about the possible risks that GMOs can cause to public health or the environment
p.(None): and to biological diversity, they may review the permits granted and, where appropriate, suspend their effects or revoke
p.(None): said permits, in accordance with the procedures established by the regulations that derive from this
p.(None): Law, when considering as causes that:
p.(None): I. There is a change in the circumstances of the activities that may influence the outcome of the study of the
p.(None): assessment of possible risks on which the permit was based, or
p.(None): II. Have additional scientific or technical information that could modify any
p.(None): conditions, limitations or permit requirements.
p.(None): CHAPTER VII
p.(None): Confidentiality
p.(None): ARTICLE 70.- Those interested may clearly identify in their permit application, that information
p.(None): that should be considered confidential according to the industrial property or copyright regime. The
p.(None): Corresponding secretariat shall be subject to the provisions of the laws of the matter and shall refrain from ordering to register and
p.(None): to provide third parties with information and data that are protected by these laws.
p.(None): ARTICLE 71.- They shall not be confidential:
p.(None): I. The general description of GMOs;
p.(None): II. The identification of the interested party or person responsible for the activity;
p.(None): III. The purpose and place or places of the activity;
p.(None): 25 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Biosafety, monitoring, control and emergency systems and measures, and
p.(None): V. Studies on possible risks to human health or the environment and biological diversity.
p.(None): Access to the information referred to in the previous sections shall be governed, in addition, by the provisions
p.(None): applicable in matters of access to government public information.
p.(None): CHAPTER VIII
p.(None): Export of GMOs destined for release to the environment in other countries
p.(None): ARTICLE 72.- Those interested in exporting GMOs that are destined for their release to the environment in other countries, will notify
p.(None): by itself, as determined in the regulations that derive from this Law, its intention to
p.(None): export said organisms to the competent authorities of the respective country Such notification only
p.(None): it will be carried out in cases where international treaties and agreements in which the
p.(None): United Mexican States are a party, establish that requirement to export to the country of
p.(None): try. The information that the interested party attaches to the notification referred to in this article must be exact,
p.(None): Reliable and in accordance with what is established in these international treaties and agreements.
p.(None): THIRD TITLE
p.(None): Confined Use and Notices
p.(None): CHAPTER I
p.(None): Confined use
p.(None): ARTICLE 73.- The confined use of GMOs may be for educational purposes, of
p.(None): scientific and technological, industrial or commercial research.
p.(None): ARTICLE 74.- Those who carry out confined use activities subject to the requirement of
p.(None): presentation of notice in the terms of this Law, must comply with the following:
p.(None): I. Keep a log book of the activities of confined use they carry out, which must be provided
p.(None): to the corresponding Secretariats when they request it;
p.(None): II. Apply confinement measures whose execution should be adapted to scientific knowledge and
p.(None): more modern and advanced technicians in risk management and treatment, final disposal and
p.(None): elimination of GMO residues generated during the activity, and
p.(None): III. In the case of the use confined for teaching or scientific research purposes and
p.(None): technology, integrate an internal biosafety commission and apply the principles of good practice of
p.(None): scientific research, as well as the biosafety rules defined by the internal commission of
p.(None): Biosafety This internal commission will be responsible for the security of the facilities and the
p.(None): good practices and safety in the management of GMOs used in the indicated activity.
p.(None): The official Mexican norms that derive from this Law will establish:
p.(None): A) The requirements and general characteristics that must be contained in the log book referred to in this
p.(None): article, for each type of activity;
...
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): C) The driving conditions that are required in the various forms of confined use of said organisms, and
p.(None): D) Actions to be taken in case of accidental release of GMOs.
p.(None): ARTICLE 75.- The storage or deposit of GMOs or products containing them, which is carried out at customs
p.(None): of the national territory, will be subject to what the respective official Mexican standards that
p.(None): jointly issue the competent Secretariats, with the participation of the SHCP.
p.(None): ARTICLE 76.- The transport of GMOs or products containing them, as well as the transit of said organisms and
p.(None): Products throughout the national territory, when they have another country as their destination, will be governed by the rules
p.(None): Mexican officials who jointly issue the competent Secretariats, with the participation
p.(None): of the Ministry of Communications and Transportation.
p.(None): CHAPTER II
p.(None): Of the Notices
p.(None): ARTICLE 77.- The notice is the communication that the subjects indicated in
p.(None): this Law, to SEMARNAT or SAGARPA, as appropriate according to this order, with respect to the
p.(None): Confined use of GMOs in the cases established in this chapter.
p.(None): ARTICLE 78.- Notices must be submitted to SEMARNAT or SAGARPA, in accordance with the attributions of this Law.
p.(None): confers them, in the official formats that are issued for this purpose. The content of the formats
p.(None): They will determine said Secretariats, with the prior approval of the Federal Regulatory Improvement Commission. In sayings
p.(None): formats will determine the information and documentation that the interested party must submit. The formats must be
p.(None): publish in the Official Gazette of the Federation.
p.(None): ARTICLE 79.- Require notice submission:
p.(None): I. GMOs that are managed, generated and produced for scientific and technological teaching and research purposes;
p.(None): II. The integration of internal biosafety commissions, including the name of the
p.(None): responsible for said commissions;
p.(None): III. The first use of laboratories or specific teaching or research facilities
p.(None): scientific and technological in which GMOs are managed, generated and produced;
p.(None): IV. The production of GMOs used in industrial processes, and
p.(None): V. The first use of specific facilities where the GMOs referred to occur
p.(None): the previous fraction.
p.(None): ARTICLE 80.- The import of GMOs for use is also required for presentation of notice.
p.(None): confined for industrial or commercial purposes, only when the following assumptions are met:
p.(None): I. That they are GMOs that do not require permission, by virtue of which they are destined exclusively for their use
p.(None): confined and therefore not imported for release to the environment, and
p.(None): 27 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): II. That they are GMOs that do not require sanitary authorization because they will not be used for human use or consumption or
p.(None): for public health purposes.
p.(None): ARTICLE 81.- The subjects that must present the corresponding notice to the corresponding Secretariat are the following:
p.(None): I. In the cases referred to in sections I, II and III of article 79, the head of the internal commission of
p.(None): biosafety of the institution, center or company where the teaching activities are carried out and
p.(None): scientific and technological research in which the GMO in question is generated and produced;
p.(None): II. In the cases referred to in sections IV and V of article 79, the legal representative of the company in the
p.(None): that the GMOs in question occur, and
p.(None): III. In the case referred to in the previous article, the importer of the GMO.
p.(None): ARTICLE 82.- It is excepted from the presentation of notice, the use confined or imported for that activity, in
p.(None): if the GMO in question exempts from said requirement in the lists issued by the
p.(None): Secretariats under this Law.
p.(None): ARTICLE 83.- The confined use of GMOs and the importation of said organisms for that activity, may
p.(None): be made from the moment the internal biosafety commission or the importer, according to
p.(None): try, present the respective notice to the corresponding Secretariat.
p.(None): ARTICLE 84.- Once the notice has been submitted, the corresponding Secretariat may determine, where appropriate, with support
p.(None): scientific and technical:
p.(None): I. That in consideration of the genetically modified organism and the possible risks in its management, the
p.(None): exercise;
p.(None): II. If applicable, it may resolve that the confined use requires the adoption and implementation of requirements and
p.(None): Biosafety measures additional to those indicated by the interested party in the notice, which will be determined
p.(None): by said Secretariat, and must be observed and complied with by the interested party to continue the completion of the
p.(None): activity, or
p.(None): III. The prohibition of the confined use of the genetically modified organism in question or its importation
p.(None): For that activity.
p.(None): Said resolution may be challenged through the appeal for review established herein.
p.(None): ordering
p.(None): ARTICLE 85.- Persons whose activity of confined use is subject to the requirement of
p.(None): Notice submission will be required to observe and comply with the other provisions of this
p.(None): ordinance and the official Mexican norms that derive from it, as applicable.
p.(None): FOURTH TITLE
p.(None): Restricted Areas
p.(None): CHAPTER I
p.(None): Centers of Origin and Genetic Diversity
p.(None): 28 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 86.- The species of which the United Mexican States is a center of origin and genetic diversity as well
p.(None): as the geographical areas in which they are located, will be determined jointly through agreements by the
p.(None): SEMARNAT and SAGARPA, based on the information they have in their files or in their databases,
p.(None): including the one that provides, among others, the National Institute of Statistics, Geography and Informatics,
p.(None): the National Institute of Forestry, Agricultural and Livestock Research, the National Institute of
p.(None): Ecology, the National Commission for the Knowledge and Use of Biodiversity and the National Commission
p.(None): Forestry, as well as international agreements and treaties related to these matters. SEMARNAT and SAGARPA
...
p.(None): CHAPTER I
p.(None): Of GMO Authorizations
p.(None): ARTICLE 91.- The GMOs subject to authorization are the following:
p.(None): I. Those that are intended for human use or consumption, including grains;
p.(None): II. Those that are used for food processing for human consumption;
p.(None): III. Those with public health purposes, and
p.(None): IV. Those that are destined to bioremediation.
p.(None): For the purposes of this Law, GMOs for human use or consumption are also considered to be those for consumption
p.(None): animal and that can be consumed directly by the human being.
p.(None): ARTICLE 92.- The request for authorization of a GMO must be accompanied by the following requirements:
p.(None): I. The study of the possible risks that the human use or consumption of the GMO in question could represent the
p.(None): human health, which will include scientific and technical information related to its safety, and
p.(None): 30 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): II. The other requirements that are determined in the official Mexican norms that derive from this Law.
p.(None): The guidelines, criteria, characteristics and requirements of the studies of the possible risks that GMOs may
p.(None): cause to human health, will be determined by the SSA in the official Mexican standards issued
p.(None): in accordance with this Law.
p.(None): ARTICLE 93.- In the case of authorization requests from a GMO to be able to import
p.(None): for the purposes referred to in article 91 of this Law, in addition to what is established in the previous article,
p.(None): the interested party must attach the information and documentation proving that the GMO is authorized
p.(None): according to the legislation of the country of origin. Failing that, the interested party will manifest the absence of said
p.(None): situation, and will expose the elements of consideration that support the SSA can resolve the request for
p.(None): authorization.
p.(None): ARTICLE 94.- Once the SSA receives an authorization request, and as long as it complies with the information
p.(None): and the requirements established in this Law, you must send it to the Registry, for its registration and publicity
p.(None): respective.
p.(None): ARTICLE 95.- Authorizations must be issued within a period not exceeding six months from
p.(None): after the SSA receives the authorization request from the interested party and the information
p.(None): provided in said application is complete.
p.(None): ARTICLE 96.- The SSA will issue its resolution, once it has analyzed the information and documentation
p.(None): contributed by the interested party. Said Secretariat in its resolution may, founded and motivated:
p.(None): I. Issue the authorization, or
p.(None): II. Deny authorization in the following cases:
p.(None): A) When the request does not comply with the provisions of this Law or the official Mexican regulations such as
p.(None): requirements for the granting of authorization;
p.(None): B) When the information provided by the interested party is false, incomplete or insufficient, or
p.(None): C) When the SSA concludes that the risks that such organisms may present will negatively affect
p.(None): human health, which can cause serious or irreversible damage.
p.(None): The SSA will base its resolutions in accordance with the scientifically and technically supported identification of the possible
p.(None): risks that GMOs could generate, and the real possibility of affecting human health by these organisms.
p.(None): ARTICLE 97.- GMOs authorized by the SSA may be freely marketed and imported for
p.(None): commercialization, as well as products containing said organisms and products derived therefrom.
p.(None): The foregoing without prejudice to said authorized bodies, the products containing them and the products
p.(None): derivatives are subject to the general health control regime established by the General Health Law and its
p.(None): regulations and, if applicable, the corresponding phytozoosanitary requirements.
p.(None): 31 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 98.- The relative provisions shall apply to the administrative authorization procedure.
p.(None): of the Second Title, regarding the Reconsideration of Negative Resolutions, Review of Permits and
p.(None): Confidentiality
p.(None): CHAPTER II
p.(None): Additional Provisions
p.(None): ARTICLE 99.- The packaging of GMOs and products containing them, for human use or consumption, is
p.(None): will be governed by the official Mexican regulations issued by the SSA, together with the Secretariat of
p.(None): Economy, in accordance with the General Health Law and its regulatory provisions, and with the
...
p.(None): with the provisions of the General Health Law and its regulatory provisions, with the participation of the Secretariat
p.(None): of Economy.
p.(None): The information contained in the labels, in accordance with the provisions of this article, must be truthful, objective,
p.(None): Clear, understandable, useful for the consumer and supported by scientific and technical information.
p.(None): The labeling of GMOs that are seeds or vegetative material intended for sowing, cultivation and production
p.(None): agricultural, will be subject to the official Mexican standards issued by SAGARPA with the participation of the Secretariat
p.(None): of Economy. Regarding this type of GMOs, it will be mandatory to record on the label that these are organisms
p.(None): genetically modified, the characteristics of the acquired genetic combination and its relative implications
p.(None): to special conditions and crop requirements, as well as changes in reproductive characteristics and
p.(None): productive.
p.(None): The conformity assessment of said official Mexican standards will be carried out by the SSA, SAGARPA and
p.(None): the Ministry of Economy within the scope of their respective competencies and the persons accredited and approved according
p.(None): to the provisions of the Federal Law on Metrology and Standardization.
p.(None): ARTICLE 102.- The information requirements that must be included in the documentation that accompanies the GMOs that are
p.(None): Import according to this Law, they will be established in official Mexican norms that derive from this ordinance,
p.(None): considering in its expedition the purpose to which said organisms are destined and what is
p.(None): establish in international treaties to which the United Mexican States are a party. The rules
p.(None): Mexican officials referred to in this article will be issued jointly by SAGARPA, SSA and the
p.(None): Ministry of Economy In the event that the import of GMOs is carried out for the purpose of their release into the environment,
p.(None): The official Mexican standards referred to in this article will be issued by the designated Secretariats
p.(None): jointly with SEMARNAT.
p.(None): SEVENTH TITLE
p.(None): 32 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): From the Lists of GMOs
p.(None): ARTICLE 103.- The lists of GMOs that are issued and published under this Law shall be the following:
p.(None): I. Those of GMOs that have permission for their commercial release or for their importation for that activity;
p.(None): II. Those of GMOs that do not have permission for their commercial release or for their importation for that activity;
p.(None): III. Those of GMOs authorized by the SSA, and
p.(None): IV. Those of GMOs to carry out activities of confined use of GMOs for teaching and research purposes
p.(None): Scientific and technological
p.(None): The lists of GMOs referred to in this article will be issued and published by the competent Secretariats with the
p.(None): periodicity established by the regulations that derive from this Law and in accordance with
p.(None): established in this Title. They will have the purpose of making the interested parties and the public known
p.(None): in general, the result of the resolutions issued regarding permit applications and
p.(None): authorizations
p.(None): ARTICLE 104.- The list of GMOs referred to in sections I and II of the previous article shall be
...
p.(None): measures that are established in this article, in the event that in carrying out activities with GMOs the
p.(None): next:
p.(None): I. Risks not originally foreseen arise, which could cause damage or adverse effects and
p.(None): significant to human health or biological diversity or animal, plant or aquaculture health;
p.(None): II. Damage or adverse and significant effects are caused to human health or biological diversity or health
p.(None): animal, vegetable or aquaculture, or
p.(None): III. GMOs not allowed and / or unauthorized into the environment are accidentally released.
p.(None): In these cases, the measures may be the following:
p.(None): A. Temporary, partial or total closure of the places and / or facilities in which they are handled or
p.(None): store GMOs or develop activities that give rise to the assumptions that give rise to taxation
p.(None): of the measure;
p.(None): B. The precautionary assurance of GMOs, in addition to goods, vehicles, utensils and instruments directly
p.(None): related to the action or omission that gives rise to the measure;
p.(None): C. The temporary, total or partial suspension of the activity that motivates the imposition of the measure;
p.(None): 36 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): D. The repatriation of GMOs to their country of origin;
p.(None): E. The performance of the necessary actions and measures to avoid continuing to present the assumptions that
p.(None): motivate the imposition of the measure, and
p.(None): F. The destruction of GMOs in question, at the expense of the interested party, for which the following should be addressed:
p.(None): a) Proceed only if the risks or damages are serious or irreparable, and only by
p.(None): the imposition of this measure is possible to avoid, mitigate or mitigate the risks or damages that motivated it;
p.(None): b) To determine the imposition of the measure, the competent Secretariat must issue an opinion, based on technical and
p.(None): scientifically, by means of which the origin of the destruction of the GMO in question is justified,
p.(None): having to make it known to the interested party, so that the latter within five days exposes
p.(None): what is convenient for you and, where appropriate, provide the evidence you have, and
p.(None): c) As long as the competent Secretariat dictates the corresponding resolution, it may order, in advance,
p.(None): the precautionary assurance of GMOs, which can be carried out by the Secretariat itself or through the
p.(None): interested.
p.(None): Likewise, the competent Secretariat that imposes the measures referred to in this article may promote
p.(None): before the other competent Secretariats, the execution of some or some measures established in
p.(None): Other systems.
p.(None): ARTICLE 116.- When the competent Secretariats order any of the measures provided for in the previous article,
p.(None): they will indicate to the interested party the actions that must be carried out to correct the irregularities that motivated
p.(None): the imposition of said measures, as well as the deadlines for their realization, so that once these have been fulfilled,
p.(None): Order the withdrawal of the measures imposed.
p.(None): If the interested party will refuse to carry out the actions to correct the irregularities that
p.(None): motivated the imposition of the measure (s) in question, the Secretariat that has imposed them
p.(None): will perform immediately, with full charge to the reluctant interested party.
p.(None): In the event that the interested party carries out security measures or urgently applied or remedies irregularities
p.(None): incurred, prior to the competent Secretariat imposing some or some of the sanctions
p.(None): established in this Law, said Secretariat shall consider such situation as mitigating the infraction.
p.(None): committed.
p.(None): ARTICLE 117.- In case of accidental releases of GMOs that are verified in the national territory,
p.(None): and that they could have significant adverse effects on the biological diversity or human health of
p.(None): another country, the competent Secretariat shall notify such situation to the corresponding authority of the country that could
p.(None): be affected by such release. Such notification must include:
p.(None): I. Information on the estimated quantities and the characteristics and / or important features of the GMO;
p.(None): II. Information on the circumstances and the estimated date of the accidental release, as well as the use of the
p.(None): GMO in the national territory;
p.(None): III. Information available on possible adverse effects for biological diversity and human health;
p.(None): 37 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Information available on possible regulatory measures, attention and risk control, and
p.(None): V. A point of contact for additional information.
p.(None): Notwithstanding the foregoing, the Secretariats, within the scope of their powers under this Law, will carry out the
...
p.(None): X. Failure to review, implement or adopt new sanitary, monitoring, control and
p.(None): prevention, in the cases in which the competent Secretariats so determine in accordance with the provisions of this Law;
p.(None): XI Carry out activities with GMOs or with any other body whose purpose is the manufacture and / or use of
p.(None): biological weapons;
p.(None): XII. Make releases of GMOs in centers of origin and genetic diversity, outside the cases
p.(None): established in this Law;
p.(None): XIII Carry out activities with GMOs in the protected natural areas indicated in this Law, outside the cases
p.(None): established by it;
p.(None): XIV Failure to inform the SEMARNAT or SAGARPA, according to their field of competence
p.(None): pursuant to this Law, through the corresponding report, the results of the release
p.(None): experimental or pilot program releases, which have the respective permit;
p.(None): XV. Import GMOs that are prohibited in the country of origin or are classified as not allowed for
p.(None): its commercial release or for its importation for that activity in the lists referred to in this Law, when
p.(None): Corresponding secretariats would not have positively determined that these prohibitions are not applicable in the
p.(None): National territory;
p.(None): XVI. Present the notices to the corresponding Secretariats without being signed by the person who must do it
p.(None): compliance with this Law;
p.(None): XVII Do not carry and / or do not provide the corresponding Secretariat with the logbook of the activities that are
p.(None): perform in confined use, in the terms established in this Law and in the official norms
p.(None): Mexicans that derive from it;
p.(None): XVIII. Do not suspend the activity of use confined in cases where the Secretariats
p.(None): corresponding, once the notice has been submitted by the interested party, determine said situation and, in its
p.(None): case, that the activity requires additional biosecurity requirements or measures to continue its
p.(None): realization;
p.(None): XIX. Perform confined utilization activities by ceasing to apply confinement and treatment measures,
p.(None): final disposal and disposal of GMO residues generated in carrying out the activity;
p.(None): XX. Breaches the provisions regarding the generation, treatment, confinement, final disposal, destruction or
p.(None): GMO waste disposal, established in the official Mexican regulations derived from this
p.(None): ordering;
p.(None): XXI. Do not integrate the internal biosafety commissions in the cases, forms and deadlines established by the
p.(None): regulatory provisions derived from this Law;
p.(None): XXII. Breaches the obligation to carry out security or urgent actions and measures
p.(None): application established by the competent Secretariats, in the cases and terms established in this Law;
p.(None): 39 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): XXIII. Failure to comply with the provisions of this Law and the official Mexican regulations derived therefrom, related to the
p.(None): labeling of products containing GMOs and products derived from said organisms;
p.(None): XXIV Fail to comply with the provisions of this ordinance and the official Mexican regulations derived therefrom, related to
p.(None): the identification of GMOs;
p.(None): XXV Perform activities of confined use of GMOs, other than those expressed in the notices presented in
p.(None): the terms of this Law;
...
Searching for indicator political:
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p.(None): Corresponding National Standardization Consultants and joining the National Standardization Program, within
p.(None): a term not exceeding six months from the entry into force of this ordinance, in accordance and
p.(None): for the effects established in the Federal Law on Metrology and Standardization.
p.(None): The preliminary draft of the other official Mexican standards referred to in this Law shall be submitted within the term of
p.(None): one year from the entry into force of this ordinance, for the purposes indicated in the paragraph
p.(None): previous.
p.(None): While the official Mexican standards referred to in articles 42, section VII, 50 section V and 55 are issued
p.(None): Section VII of this Law, SEMARNAT and SAGARPA, in their respective fields of competence, may determine the
p.(None): information deemed necessary, with the participation that corresponds to the Federal Improvement Commission
p.(None): Regulatory, and within a period not exceeding one year from the entry into force of the
p.(None): present order, in order to issue the corresponding permits.
p.(None): TENTH ARTICLE.- All legal provisions that oppose this Law are repealed.
p.(None): 43 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): Mexico, D.F., February 15, 2005.- Dip. Manlio Fabio Beltrones Rivera, President.- Sen. Diego Fernández de
p.(None): Cevallos Ramos, President.- Dip. Marcos Morales Torres, Secretary.- Sen. Sara I. Castellanos Cortés,
p.(None): Secretary.- Rubrics. "
p.(None): In compliance with the provisions of section I of Article 89 of the Political Constitution of the
p.(None): United Mexican States, and for due publication and observance, I issue this Decree in the Residence of
p.(None): Federal Executive Power, in Mexico City, Federal District, on the seventeenth day of the month of March two
p.(None): One thousand five.- Vicente Fox Quesada.- Rubric.- The Secretary of the Interior, Santiago Creel Miranda.- Rubric.
...
Political / stateless persons
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p.(None): Animal, the Federal Plant Health Law, the Fishing Law, the Sustainable Rural Development Law, and
p.(None): of the other applicable provisions, and
p.(None): 6 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): III. The corresponding environmental measures to adopt to the Ministry of Environment and Natural Resources
p.(None): under the terms of the General Law of Ecological Balance and Environmental Protection, of the General Law
p.(None): of Wildlife, the General Law on Sustainable Forest Development and other applicable laws in that area,
p.(None): except for:
p.(None): A) The environmental impact assessment and risk study regulated in Section V of Chapter IV of the Title
p.(None): First and in Chapter V of Title Four, of the General Law of Ecological Balance and Environmental Protection, and
p.(None): B) The processing and issuance of permits and other control and monitoring instruments that regulate
p.(None): this law.
p.(None): ARTICLE 8.- In the absence of express provision in this ordinance, the provisions of the Federal Law shall be followed.
p.(None): of Administrative Procedure.
p.(None): CHAPTER II
p.(None): Principles in Biosafety
p.(None): ARTICLE 9.- For the formulation and conduct of the biosafety policy and the issuance of regulations and
p.(None): of the official Mexican norms that derive from this Law, the following principles will be observed:
p.(None): I. The Mexican Nation has a biodiversity of the largest in the world, and its territory is
p.(None): find areas that are the center of origin and genetic diversity of species and varieties that must be
p.(None): protected, used, empowered and sustainably exploited, for being a valuable reservoir of wealth in
p.(None): molecules and genes for the sustainable development of the country;
p.(None): II. The State has the obligation to guarantee the right of every person to live in an environment suitable for
p.(None): their food, health, development and well-being;
p.(None): III. The biosecurity of GMOs aims to ensure an adequate level of protection in the area of
p.(None): Confined use, experimental release, pilot program release, commercial release,
p.(None): commercialization, importation and exportation of said organisms resulting from biotechnology
p.(None): modern that may have adverse effects for the conservation and sustainable use of the environment and the
p.(None): biological diversity, as well as human health and animal, plant and aquaculture health;
p.(None): IV. In order to protect the environment and biological diversity, the Mexican State must
p.(None): apply the precautionary approach according to their abilities, taking into account the commitments
p.(None): established in international treaties and agreements to which the United Mexican States are a party.
p.(None): When there is a danger of serious or irreversible damage, the lack of absolute scientific certainty should not be used as
p.(None): reason to postpone the adoption of cost-effective measures to prevent degradation
p.(None): of the environment and biological diversity. Such measures shall be adopted in accordance with the provisions and
p.(None): administrative procedures established in this Law;
...
p.(None): establish the institutions, centers or companies, whether public or private, that carry out these activities;
p.(None): VIII. The possible risks that activities with GMOs could produce to human health and diversity
p.(None): Biological will be evaluated on a case-by-case basis. This evaluation will be based on the best scientific evidence and
p.(None): available technique;
p.(None): IX. The release of GMOs into the environment must be done "step by step" according to which, all GMOs
p.(None): that is intended to be released commercially must be previously subjected to satisfactory tests
p.(None): according to risk studies, risk assessment and reports of results applicable in the
p.(None): carrying out experimental release and pilot program release activities of said organizations, in the
p.(None): terms of this Law;
p.(None): X. Adverse effects that the release of GMOs could cause to biological diversity should be monitored,
p.(None): also taking into account the possible risks to human health;
p.(None): XI Administrative procedures to grant permits and authorizations to perform
p.(None): activities with GMOs must be effective and transparent; in the issuance of regulations and official standards
p.(None): Mexican that derive from this Law, the commitments established in treaties and agreements must be observed
p.(None): internationals in which the United Mexican States are a part, so that its content and scope are
p.(None): compatible with said treaties and agreements;
p.(None): XII. It is necessary to support technological development and scientific research on organisms
p.(None): genetically modified that can contribute to meet the needs of the Nation;
p.(None): XIII For the analysis of solutions to particular problems, benefits and possible benefits will be assessed on a case-by-case basis.
p.(None): risks of the use of GMOs. This analysis may also include the risk assessment of technological options
p.(None): alternates to contend with the specific problem for which the GMO was designed. Said comparative analysis
p.(None): It must be based on scientific and technical evidence, as well as background on use, production and consumption,
p.(None): and may be an additional element to the risk assessment study to decide, casuistically, on the
p.(None): release to the environment of the GMO in question;
p.(None): XIV Adequate capacity and regulations must be provided to prevent accidental release
p.(None): to the environment of GMOs coming from residues of any type of processes in which they have been used
p.(None): organisms;
p.(None): XV. The application of this Law, administrative procedures and criteria for the evaluation of possible
p.(None): risks that could be generated by the activities regulated by this Law, the control instruments of said activities, the
p.(None): monitoring of them, their regulations and the official Mexican norms that derive from it, the procedures of
p.(None): inspection and surveillance to verify and verify compliance with this Law and the provisions that
p.(None): they derive, the implementation of security measures and urgent application, and the application of
p.(None): sanctions for violations of the precepts of this Law and the provisions that emanate from it, are the form
p.(None): in which the Mexican State acts with caution, prudently and with scientific and technical bases to prevent,
...
Health / Drug Usage
Searching for indicator influence:
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p.(None): experimental to the environment, and consequent releases to the environment in pilot and commercial program, respectively,
p.(None): of the GMO in question.
p.(None): ARTICLE 65.- The characteristics and requirements of the studies to evaluate the possible risks shall be established.
p.(None): in the official Mexican norms that derive from this Law.
p.(None): CHAPTER IV
p.(None): Of the opinions
p.(None): ARTICLE 66.- The opinions that the SEMARNAT must issue will only be required in the case of
p.(None): experimental release activities, pilot program release and commercial release of GMOs
p.(None): that are the responsibility of SAGARPA. These opinions must be issued within a period of sixty days from
p.(None): after SEMARNAT receives the administrative file sent by SAGARPA. This term includes
p.(None): both the issuance of the corresponding opinion, and its referral to SAGARPA. SAGARPA will issue the permit of
p.(None): release of GMOs to the appropriate environment, provided that the opinion issued by SEMARNAT is favorable.
p.(None): 24 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): CHAPTER V
p.(None): On the Reconsideration of Negative Resolutions
p.(None): ARTICLE 67.- Those interested in whom the corresponding Secretariat has denied the requested permission may
p.(None): request said Secretariat to reconsider the respective resolution, when it is considered that:
p.(None): I. There has been a change in circumstances that may influence the outcome of the study of possible
p.(None): risks on which the resolution was based, or
p.(None): II. New relevant scientific or technical information is available from which it follows that
p.(None): Possible risks identified are not those originally intended.
p.(None): The competent Secretariat may issue a resolution within two months. In case of not doing so, it
p.(None): will consider the reconsideration dismissed.
p.(None): ARTICLE 68.- The reconsideration referred to in the preceding article does not constitute any remedy or means of defense,
p.(None): and may be promoted by interested parties regardless of whether they enforce the means of challenge established in
p.(None): This Law against the resolution that affects them.
p.(None): CHAPTER VI
p.(None): From the Permit Review
p.(None): ARTICLE 69.- The corresponding Secretariat, at any time and on the basis of new information
p.(None): scientific or technical about the possible risks that GMOs can cause to public health or the environment
p.(None): and to biological diversity, they may review the permits granted and, where appropriate, suspend their effects or revoke
p.(None): said permits, in accordance with the procedures established by the regulations that derive from this
p.(None): Law, when considering as causes that:
p.(None): I. There is a change in the circumstances of the activities that may influence the outcome of the study of the
p.(None): assessment of possible risks on which the permit was based, or
p.(None): II. Have additional scientific or technical information that could modify any
p.(None): conditions, limitations or permit requirements.
p.(None): CHAPTER VII
p.(None): Confidentiality
p.(None): ARTICLE 70.- Those interested may clearly identify in their permit application, that information
p.(None): that should be considered confidential according to the industrial property or copyright regime. The
p.(None): Corresponding secretariat shall be subject to the provisions of the laws of the matter and shall refrain from ordering to register and
p.(None): to provide third parties with information and data that are protected by these laws.
p.(None): ARTICLE 71.- They shall not be confidential:
p.(None): I. The general description of GMOs;
p.(None): II. The identification of the interested party or person responsible for the activity;
p.(None): III. The purpose and place or places of the activity;
p.(None): 25 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Biosafety, monitoring, control and emergency systems and measures, and
p.(None): V. Studies on possible risks to human health or the environment and biological diversity.
p.(None): Access to the information referred to in the previous sections shall be governed, in addition, by the provisions
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): this law.
p.(None): 2 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): III. Authorization: It is the administrative act through which the Ministry of Health, within the scope of its competence
p.(None): pursuant to this Law, authorizes genetically modified organisms expressly determined in this
p.(None): ordering, so that it can be carried out its commercialization and import for its commercialization, as well as its
p.(None): use for public health or bioremediation purposes.
p.(None): IV. Bioremediation: The process in which genetically modified microorganisms are used for
p.(None): degradation or disintegration of pollutants that affect resources and / or natural elements, in order to convert them into
p.(None): simpler components and less harmful or not harmful to the environment.
p.(None): V. Biosecurity: The actions and measures of evaluation, monitoring, control and prevention that must be assumed
p.(None): in carrying out activities with genetically modified organisms, in order to prevent, avoid or
p.(None): reduce the possible risks that such activities could cause to human health or the environment
p.(None): and biological diversity, including safety aspects of said organisms that are intended for use or consumption
p.(None): human.
p.(None): SAW. Modern biotechnology: The application of in vitro nucleic acid techniques, including acid, is understood
p.(None): recombinant deoxyribonucleic (DNA and RNA) and direct injection of nucleic acid into cells or organelles, or the
p.(None): cell fusion beyond the taxonomic family, which overcomes the natural physiological barriers of reproduction
p.(None): or recombination and that are not techniques used in traditional reproduction and selection, which are applied to
p.(None): give rise to genetically modified organisms, which are determined in the official Mexican standards that derive from
p.(None): this law.
p.(None): VII. Case by case: Individual assessment of genetically modified organisms,
p.(None): based on the available scientific and technical evidence, considering, among other aspects, the
p.(None): recipient organism, the area of release and the characteristics of the genetic modification, as well as the background
p.(None): that exist on carrying out activities with the agency in question and the benefits
p.(None): compared to alternative technological options to contend with the specific problem.
p.(None): VIII. Center of origin: It is that geographical area of the national territory where the process of
p.(None): domestication of a particular species.
p.(None): IX. Center of genetic diversity: It is that geographical area of the national territory where there is
p.(None): morphological diversity, genetic or both of certain species, which is characterized by housing
p.(None): populations of wild relatives and that constitutes a genetic reserve.
p.(None): X. Marketing: It is the introduction to the market for distribution and consumption of genetically organisms
p.(None): modified as products or merchandise, without intentional release purposes
p.(None): environment and regardless of the profit motive and the legal title under which it is carried out.
p.(None): XI CIBIOGEM: The Inter-secretarial Commission of Biosafety of Genetically Modified Organisms.
p.(None): XII. CONACyT: The National Council of Science and Technology.
p.(None): XIII Biological diversity: The variability of living organisms from any source, including, among others
...
Health / stem cells
Searching for indicator stem cells:
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p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): marketing and import for marketing. Likewise, the authorization of
p.(None): GMOs, other than the above, that are intended for public health purposes or bioremediation.
p.(None): ARTICLE 6.- The following are excluded from the scope of this Law:
p.(None): I. Activities of confined use, experimental release, pilot program release and
p.(None): Commercial release, commercialization, import and export of GMOs, when the genetic modification of
p.(None): such organisms are obtained by traditional mutagenesis or cell fusion techniques, including protoplasts
p.(None): of plant cells, in which the resulting organisms can also be produced by traditional methods
p.(None): of multiplication or culture in vivo or in vitro, provided that these techniques do not involve the use of
p.(None): genetically modified organisms such as receptor or parental organisms;
p.(None): II. The use of in vitro fertilization techniques, conjugation, transduction, transformation or
p.(None): any other natural process and polyploid induction, provided that no acid molecules are used
p.(None): recombinant deoxyribonucleic (DNA) or genetically modified organisms;
p.(None): III. The production and process of medicines and drugs with GMOs generated from confined processes whose
p.(None): regulation corresponds to the General Health Law;
p.(None): IV. The sanitary control of derived products and the confined production processes in which GMOs intervene
p.(None): authorized under this Law, for human or animal use or consumption, which are subject to the provisions of
p.(None): the General Health Law and its regulations applicable to all products and processes;
p.(None): V. The human genome, the culture of stem cells of humans, the modification of human germ cells and
p.(None): the biosafety of hospitals, whose regulation corresponds to the General Health Law, and to the International Treaties
p.(None): in which the United Mexican States are a party;
p.(None): SAW. The collection and use of biological resources, whose regulation corresponds to the General Law
p.(None): of Ecological Balance and Protection of the Environment, the General Wildlife Law, and the Treaties
p.(None): Internationals in which the United Mexican States are a party, and
p.(None): VII. The intellectual property of biotechnological products and processes, which is the subject of the Property Law
p.(None): Industrial, Federal Law on Plant Varieties and International Treaties in which the United States
p.(None): Mexicans be part.
p.(None): ARTICLE 7.- The activities, organizations and products subject to the scope of this Law, will not require, in matters of
p.(None): biosecurity and safety, of other permits, authorizations, notices and, in general, requirements, procedures and
p.(None): restrictions than those established in this system.
p.(None): It is excepted from the provisions of the preceding paragraph:
p.(None): I. The measures that in the matter of general health correspond to adopt to the Secretariat of Health in the terms of
p.(None): the General Health Law and its regulations, except for the processing and issuance of
p.(None): authorizations regulated by this Law;
p.(None): II. The measures that in the matter of animal, vegetable and aquaculture health correspond to adopt to the Secretariat
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): risks that could be generated by the activities regulated by this Law, the control instruments of said activities, the
p.(None): monitoring of them, their regulations and the official Mexican norms that derive from it, the procedures of
p.(None): inspection and surveillance to verify and verify compliance with this Law and the provisions that
p.(None): they derive, the implementation of security measures and urgent application, and the application of
p.(None): sanctions for violations of the precepts of this Law and the provisions that emanate from it, are the form
p.(None): in which the Mexican State acts with caution, prudently and with scientific and technical bases to prevent,
p.(None): reduce or avoid the possible risks that activities with GMOs could cause to human health or to
p.(None): environment and biological diversity;
p.(None): 8 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): XVI. The biosecurity of agricultural, fishery and aquaculture products is
p.(None): closely related to plant, animal and aquaculture health, so the policy in these
p.(None): subjects should include environmental, biological diversity, human health and plant health aspects and
p.(None): animal;
p.(None): XVII The Mexican State will cooperate in the area of information exchange and research on the effects
p.(None): socioeconomic status of GMOs, especially in indigenous and local communities;
p.(None): XVIII. The Mexican State will guarantee public access to biosafety and biotechnology information to
p.(None): referred to in this Law, in accordance with the provisions of this system and the provisions applicable to the
p.(None): matter of access to government public information, and
p.(None): XIX. Experimentation with GMOs or with any other body for manufacturing and / or use purposes
p.(None): of biological weapons is prohibited in the national territory.
p.(None): CHAPTER III
p.(None): Of the Biosafety Competencies
p.(None): ARTICLE 10.- Are competent authorities in the field of biosafety:
p.(None): I. The SEMARNAT;
p.(None): II. SAGARPA, and
p.(None): III. SSA
p.(None): The SHCP will have the powers established in this Law, regarding the import of GMOs and
p.(None): of products that contain them.
p.(None): ARTICLE 11.- It corresponds to the SEMARNAT the exercise of the following faculties regarding activities with all types
p.(None): of GMOs, except in the case of GMOs that correspond to SAGARPA:
p.(None): I. Participate in the formulation and implementation of the general biosafety policy;
p.(None): II. Analyze and evaluate on a case-by-case basis the possible risks that activities with GMOs could
p.(None): cause the environment and biological diversity, based on risk studies and reports of
p.(None): results elaborated and presented by the interested parties, in the terms of this Law;
p.(None): III. Resolve and issue permits for carrying out activities for the release of GMOs into the environment, as well as
p.(None): establish and follow up on the conditions and measures to which these activities must be subject, according to
p.(None): the provisions of this ordinance, including the release of GMOs for bioremediation;
p.(None): IV. Monitor the effects that could be caused by the release of GMOs, permitted or
p.(None): accidental, to the environment and to biological diversity, in accordance with the provisions of this Law and the regulations
p.(None): Mexican officers derived from it;
p.(None): V. Participate in the preparation and issuance of the lists referred to in this Law;
...
p.(None): I. They will define precisely the subjects and activities that constitute the object of the agreement or agreement;
p.(None): II. The purpose of the agreements or agreements must be consistent with the policy regarding
p.(None): biosecurity;
p.(None): III. The assets and resources provided by the parties will be described, clarifying their destination.
p.(None): specific and its form of administration, for which the Federation will contribute to the strengthening of its capabilities
p.(None): financial and institutional;
p.(None): IV. The necessary means, procedures and resources provided by the Secretariats will be determined
p.(None): competent, so that the governments of the federal entities can carry out the
p.(None): actions and activities subject to coordination agreements or agreements;
p.(None): V. The validity of the agreement or agreement, its forms of termination and dispute resolution and,
p.(None): where appropriate, extension;
p.(None): SAW. Define the body or bodies that will carry out the actions resulting from the agreements or agreements of
p.(None): coordination;
p.(None): VII. They will determine the actions to promote and participate jointly in supporting the
p.(None): scientific and technological research in biosafety and biotechnology;
p.(None): VIII. The obligation to submit detailed reports on compliance with the object of the agreements and
p.(None): coordination agreements, and
p.(None): IX. They will contain the other stipulations that the parties consider necessary for the correct fulfillment
p.(None): of the agreement or agreement.
p.(None): The agreements referred to in this article must be published in the Official Gazette of the Federation
p.(None): and in the official dissemination body of the respective local government.
p.(None): ARTICLE 27.- The governments of the federal entities will have permanent access to the information that is
p.(None): register in the National Biosafety Registry of Genetically Organized Organisms
p.(None): 15 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): Modified Likewise, the CIBIOGEM, through its Executive Secretariat, will notify the applications for permits from
p.(None): commercial release to the environment of GMOs, to the governments of the federal entities in which it is intended
p.(None): carry out this activity, so that they have knowledge of that situation and can issue their
p.(None): opinions in the terms of this Law. The notification must be made within twenty days following
p.(None): that in which the CIBIOGEM has received the corresponding permit application for registration in the Registry.
p.(None): CHAPTER VI
p.(None): From the Promotion to Scientific and Technological Research in Biosafety and Biotechnology
p.(None): ARTICLE 28.- The Federal Executive shall promote, support and strengthen scientific research and
p.(None): technology in biosafety and biotechnology through policies and instruments
p.(None): established in this Law and in the Law of Science and Technology. In biotechnology, these supports will be oriented
p.(None): to promote research and development and innovation projects, human resources training
p.(None): specialized and strengthening of groups and infrastructure of universities, education institutions
p.(None): superior and public research centers, which are carried out to solve productive needs
p.(None): country-specific and that directly benefit national producers.
...
p.(None): Law, when considering as causes that:
p.(None): I. There is a change in the circumstances of the activities that may influence the outcome of the study of the
p.(None): assessment of possible risks on which the permit was based, or
p.(None): II. Have additional scientific or technical information that could modify any
p.(None): conditions, limitations or permit requirements.
p.(None): CHAPTER VII
p.(None): Confidentiality
p.(None): ARTICLE 70.- Those interested may clearly identify in their permit application, that information
p.(None): that should be considered confidential according to the industrial property or copyright regime. The
p.(None): Corresponding secretariat shall be subject to the provisions of the laws of the matter and shall refrain from ordering to register and
p.(None): to provide third parties with information and data that are protected by these laws.
p.(None): ARTICLE 71.- They shall not be confidential:
p.(None): I. The general description of GMOs;
p.(None): II. The identification of the interested party or person responsible for the activity;
p.(None): III. The purpose and place or places of the activity;
p.(None): 25 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Biosafety, monitoring, control and emergency systems and measures, and
p.(None): V. Studies on possible risks to human health or the environment and biological diversity.
p.(None): Access to the information referred to in the previous sections shall be governed, in addition, by the provisions
p.(None): applicable in matters of access to government public information.
p.(None): CHAPTER VIII
p.(None): Export of GMOs destined for release to the environment in other countries
p.(None): ARTICLE 72.- Those interested in exporting GMOs that are destined for their release to the environment in other countries, will notify
p.(None): by itself, as determined in the regulations that derive from this Law, its intention to
p.(None): export said organisms to the competent authorities of the respective country Such notification only
p.(None): it will be carried out in cases where international treaties and agreements in which the
p.(None): United Mexican States are a party, establish that requirement to export to the country of
p.(None): try. The information that the interested party attaches to the notification referred to in this article must be exact,
p.(None): Reliable and in accordance with what is established in these international treaties and agreements.
p.(None): THIRD TITLE
p.(None): Confined Use and Notices
p.(None): CHAPTER I
p.(None): Confined use
p.(None): ARTICLE 73.- The confined use of GMOs may be for educational purposes, of
p.(None): scientific and technological, industrial or commercial research.
p.(None): ARTICLE 74.- Those who carry out confined use activities subject to the requirement of
p.(None): presentation of notice in the terms of this Law, must comply with the following:
p.(None): I. Keep a log book of the activities of confined use they carry out, which must be provided
p.(None): to the corresponding Secretariats when they request it;
p.(None): II. Apply confinement measures whose execution should be adapted to scientific knowledge and
...
Searching for indicator access to information:
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p.(None): in the environment and biological diversity or in animal, plant or aquaculture health;
p.(None): VII. Establish the permit regime for carrying out experimental release activities, for release in
p.(None): pilot and commercial release program of genetically modified organisms, including the importation of
p.(None): those agencies to carry out these activities;
p.(None): VIII. Establish the system of notices for carrying out activities of confined use of
p.(None): genetically modified organisms, in the cases referred to in this Law;
p.(None): IX. Establish the authorization regime of the Ministry of Health of organizations
p.(None): genetically modified that are determined in this Law;
p.(None): X. Create and develop the National Biosafety Information System and the National Biosafety Registry of
p.(None): Genetically Modified Organisms;
p.(None): XI Determine the basis for the case-by-case establishment of GMO-free geographic areas where
p.(None): prohibits and those in which the performance of activities with certain genetically restricted organisms is restricted
p.(None): modified, as well as crops of which Mexico is the center of origin, especially corn, which will maintain a
p.(None): special protection regime;
p.(None): XII. To establish the bases of the content of the official Mexican norms regarding biosafety;
p.(None): XIII Establish control measures to guarantee biosecurity, as well as sanctions
p.(None): corresponding in cases of non-compliance or violation of the provisions of this Law, their
p.(None): Mexican regulations and official norms that derive from it;
p.(None): XIV Establish mechanisms for public participation in biosafety aspects of this Law,
p.(None): including access to information, participation of the private, social and productive sectors to
p.(None): through the CIBIOGEM Joint Consultative Council, and the public consultation on applications for the release of GMOs to
p.(None): environment, and
p.(None): XV. Establish instruments to promote scientific and technological research in biosafety and biotechnology.
p.(None): ARTICLE 3.- For the purposes of this Law, it is understood by:
p.(None): I. Accident: The involuntary release of genetically modified organisms during their
p.(None): use and that may involve, based on technical criteria, possible risks to human health or the environment
p.(None): Environment and biological diversity.
p.(None): II. Activities: Confined use, experimental release, pilot program release, release
p.(None): trade, marketing, import and export of genetically modified organisms, in accordance with
p.(None): this law.
p.(None): 2 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): III. Authorization: It is the administrative act through which the Ministry of Health, within the scope of its competence
p.(None): pursuant to this Law, authorizes genetically modified organisms expressly determined in this
p.(None): ordering, so that it can be carried out its commercialization and import for its commercialization, as well as its
p.(None): use for public health or bioremediation purposes.
p.(None): IV. Bioremediation: The process in which genetically modified microorganisms are used for
p.(None): degradation or disintegration of pollutants that affect resources and / or natural elements, in order to convert them into
p.(None): simpler components and less harmful or not harmful to the environment.
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): V. Establish the basis for the functioning of the Inter-Secretariat Biosafety Commission of the Organizations
p.(None): Genetically Modified, through which the Secretariats that integrate it must collaborate in a way
p.(None): coordinated, within the scope of its competences, in relation to the biosecurity of genetically engineered organisms
p.(None): modified;
p.(None): SAW. Establish administrative procedures and criteria for the evaluation and monitoring of
p.(None): possible risks that may be caused by activities with genetically modified organisms in human health or
p.(None): in the environment and biological diversity or in animal, plant or aquaculture health;
p.(None): VII. Establish the permit regime for carrying out experimental release activities, for release in
p.(None): pilot and commercial release program of genetically modified organisms, including the importation of
p.(None): those agencies to carry out these activities;
p.(None): VIII. Establish the system of notices for carrying out activities of confined use of
p.(None): genetically modified organisms, in the cases referred to in this Law;
p.(None): IX. Establish the authorization regime of the Ministry of Health of organizations
p.(None): genetically modified that are determined in this Law;
p.(None): X. Create and develop the National Biosafety Information System and the National Biosafety Registry of
p.(None): Genetically Modified Organisms;
p.(None): XI Determine the basis for the case-by-case establishment of GMO-free geographic areas where
p.(None): prohibits and those in which the performance of activities with certain genetically restricted organisms is restricted
p.(None): modified, as well as crops of which Mexico is the center of origin, especially corn, which will maintain a
p.(None): special protection regime;
p.(None): XII. To establish the bases of the content of the official Mexican norms regarding biosafety;
p.(None): XIII Establish control measures to guarantee biosecurity, as well as sanctions
p.(None): corresponding in cases of non-compliance or violation of the provisions of this Law, their
p.(None): Mexican regulations and official norms that derive from it;
p.(None): XIV Establish mechanisms for public participation in biosafety aspects of this Law,
p.(None): including access to information, participation of the private, social and productive sectors to
p.(None): through the CIBIOGEM Joint Consultative Council, and the public consultation on applications for the release of GMOs to
p.(None): environment, and
p.(None): XV. Establish instruments to promote scientific and technological research in biosafety and biotechnology.
p.(None): ARTICLE 3.- For the purposes of this Law, it is understood by:
p.(None): I. Accident: The involuntary release of genetically modified organisms during their
p.(None): use and that may involve, based on technical criteria, possible risks to human health or the environment
p.(None): Environment and biological diversity.
p.(None): II. Activities: Confined use, experimental release, pilot program release, release
p.(None): trade, marketing, import and export of genetically modified organisms, in accordance with
p.(None): this law.
p.(None): 2 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
...
p.(None): transfer or replicate your genetic material.
p.(None): XXVII. Registry: The National Biosafety Registry of Genetically Modified Organisms.
p.(None): XXVIII. Waste: Any waste material generated in the confined use of genetically engineered organisms
p.(None): modified, including genetically modified organisms themselves.
p.(None): XXIX Secretariats: The Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food, the Secretariat of
p.(None): Environment and Natural Resources and the Ministry of Health, regarding their respective areas of
p.(None): competence established in this Law.
p.(None): XXX SAGARPA: The Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food.
p.(None): XXXI SEMARNAT: The Ministry of Environment and Natural Resources.
p.(None): XXXII SHCP: The Ministry of Finance and Public Credit.
p.(None): XXXIII SSA: The Ministry of Health.
p.(None): XXXIV Confined use: Any activity by which the genetic material of an organism is modified or by
p.(None): the one that, thus modified, is cultivated, stored, used, processed, transported, commercialized, destroyed or
p.(None): eliminate, provided that physical barriers or a combination of these with
p.(None): chemical or biological barriers, in order to effectively limit their contact with the population and the environment
p.(None): environment. For the purposes of this Law the area of the facilities or the scope of the confined use does not form
p.(None): part of the environment.
p.(None): XXXV Authorized areas: The geographic areas or regions that are determined on a case by case basis in the resolution of a
p.(None): permission, in which genetically modified organisms that may have been released into the environment
p.(None): analyzed.
p.(None): XXXVI Restricted areas: Centers of origin, centers of genetic diversity and areas
p.(None): protected areas, within which the performance of activities with organisms is restricted
p.(None): genetically modified, in the terms of this Law.
p.(None): ARTICLE 4.- The subject of this Law is the biosecurity of all GMOs obtained or produced through the
p.(None): application of the techniques of modern biotechnology referred to in this ordinance, which
p.(None): be used for agricultural, livestock, aquaculture, forestry, industrial, commercial,
p.(None): bioremediation and any other, with the exceptions established by this Law.
p.(None): ARTICLE 5.- The authorization of GMOs that are intended for human use or consumption is also the subject of this Law.
p.(None): to the processing of food for human consumption, in order to carry out its
p.(None): 5 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): marketing and import for marketing. Likewise, the authorization of
p.(None): GMOs, other than the above, that are intended for public health purposes or bioremediation.
p.(None): ARTICLE 6.- The following are excluded from the scope of this Law:
p.(None): I. Activities of confined use, experimental release, pilot program release and
p.(None): Commercial release, commercialization, import and export of GMOs, when the genetic modification of
p.(None): such organisms are obtained by traditional mutagenesis or cell fusion techniques, including protoplasts
p.(None): of plant cells, in which the resulting organisms can also be produced by traditional methods
p.(None): of multiplication or culture in vivo or in vitro, provided that these techniques do not involve the use of
p.(None): genetically modified organisms such as receptor or parental organisms;
p.(None): II. The use of in vitro fertilization techniques, conjugation, transduction, transformation or
...
p.(None): if the GMO in question exempts from said requirement in the lists issued by the
p.(None): Secretariats under this Law.
p.(None): ARTICLE 83.- The confined use of GMOs and the importation of said organisms for that activity, may
p.(None): be made from the moment the internal biosafety commission or the importer, according to
p.(None): try, present the respective notice to the corresponding Secretariat.
p.(None): ARTICLE 84.- Once the notice has been submitted, the corresponding Secretariat may determine, where appropriate, with support
p.(None): scientific and technical:
p.(None): I. That in consideration of the genetically modified organism and the possible risks in its management, the
p.(None): exercise;
p.(None): II. If applicable, it may resolve that the confined use requires the adoption and implementation of requirements and
p.(None): Biosafety measures additional to those indicated by the interested party in the notice, which will be determined
p.(None): by said Secretariat, and must be observed and complied with by the interested party to continue the completion of the
p.(None): activity, or
p.(None): III. The prohibition of the confined use of the genetically modified organism in question or its importation
p.(None): For that activity.
p.(None): Said resolution may be challenged through the appeal for review established herein.
p.(None): ordering
p.(None): ARTICLE 85.- Persons whose activity of confined use is subject to the requirement of
p.(None): Notice submission will be required to observe and comply with the other provisions of this
p.(None): ordinance and the official Mexican norms that derive from it, as applicable.
p.(None): FOURTH TITLE
p.(None): Restricted Areas
p.(None): CHAPTER I
p.(None): Centers of Origin and Genetic Diversity
p.(None): 28 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 86.- The species of which the United Mexican States is a center of origin and genetic diversity as well
p.(None): as the geographical areas in which they are located, will be determined jointly through agreements by the
p.(None): SEMARNAT and SAGARPA, based on the information they have in their files or in their databases,
p.(None): including the one that provides, among others, the National Institute of Statistics, Geography and Informatics,
p.(None): the National Institute of Forestry, Agricultural and Livestock Research, the National Institute of
p.(None): Ecology, the National Commission for the Knowledge and Use of Biodiversity and the National Commission
p.(None): Forestry, as well as international agreements and treaties related to these matters. SEMARNAT and SAGARPA
p.(None): they will establish in the agreements that issue, the necessary measures for the protection of said
p.(None): species and geographic areas.
p.(None): ARTICLE 87.- For the determination of the centers of origin and genetic diversity, the
p.(None): following criteria:
p.(None): I. That they are considered centers of genetic diversity, understanding by them the regions that currently
p.(None): they host populations of the wild relatives of the GMO in question, including different races or
p.(None): varieties thereof, which constitute a genetic reserve of the material, and
p.(None): II. In the case of crops, the geographical regions where the organism in question was
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CURRENT TEXT
p.(None): New Law published in the Official Gazette of the Federation on March 18, 2005
p.(None): On the margin a seal with the National Shield, which says: United Mexican States.- Presidency of the
p.(None): Republic.
p.(None): VICENTE FOX QUESADA, President of the United Mexican States, to its inhabitants know: May the Honorable Congress of
p.(None): the Union, has served to address the following
p.(None): DECREE
p.(None): "THE CONGRESS OF THE UNITED MEXICAN STATES, DECREE:
p.(None): THE BIOSEGURITY LAW OF GENETICALLY MODIFIED ORGANISMS IS ISSUED.
p.(None): SINGLE ARTICLE: The Law of Biosafety of Genetically Modified Organisms is issued, to read as follows:
p.(None): BIOSEURITY ACT OF GENETICALLY MODIFIED ORGANISMS FIRST TITLE
p.(None): General disposition
p.(None): CHAPTER I
p.(None): Object and Purposes
p.(None): ARTICLE 1.- This Law is of public order and of social interest, and is intended to regulate the activities of
p.(None): Confined use, experimental release, pilot program release, commercial release,
p.(None): marketing, import and export of genetically modified organisms, in order to prevent, avoid or
p.(None): reduce the possible risks that these activities could cause to human health or to the environment and to the
p.(None): biological diversity or animal, plant and aquaculture health.
p.(None): ARTICLE 2.- To fulfill its purpose, this order has the following purposes:
p.(None): I. Ensure an adequate and efficient level of protection of human health, the environment and diversity
p.(None): biological and animal, plant and aquaculture health, regarding the adverse effects that could
p.(None): cause them to carry out activities with genetically modified organisms;
p.(None): II. Define the principles and national policy on biosafety of GMOs and
p.(None): instruments for its application;
p.(None): III. Determine the powers of the various agencies of the Federal Public Administration in matters of
p.(None): Biosecurity of GMOs;
p.(None): IV. Establish the basis for concluding agreements or coordination agreements between the Federation,
p.(None): through the competent Secretariats and the governments of the federal entities, for the best compliance
p.(None): the purpose of this Law;
p.(None): 1 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
...
p.(None): be affected by such release. Such notification must include:
p.(None): I. Information on the estimated quantities and the characteristics and / or important features of the GMO;
p.(None): II. Information on the circumstances and the estimated date of the accidental release, as well as the use of the
p.(None): GMO in the national territory;
p.(None): III. Information available on possible adverse effects for biological diversity and human health;
p.(None): 37 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Information available on possible regulatory measures, attention and risk control, and
p.(None): V. A point of contact for additional information.
p.(None): Notwithstanding the foregoing, the Secretariats, within the scope of their powers under this Law, will carry out the
p.(None): actions and measures necessary to minimize any risk or adverse effect that the GMOs released
p.(None): They could accidentally cause. Such actions and measures will be ordered by the Secretariats to whom there are
p.(None): caused the accidental release of GMOs to the environment, who must comply immediately. In case
p.(None): Otherwise, the Secretariats will proceed in accordance with the provisions of the second paragraph of the previous article.
p.(None): ARTICLE 118.- The provisions of the Single Chapter of Title Five are supplementary to this Chapter.
p.(None): of the Federal Law of Administrative Procedure, except for the provisions of the previous article.
p.(None): Twelve eleventh
p.(None): Infractions, Sanctions and Responsibilities
p.(None): CHAPTER I
p.(None): Of the Infractions
p.(None): ARTICLE 119.- The person who, in full, incurs administrative violations of the provisions of this Law.
p.(None): knowledge that it is about GMOs:
p.(None): I. Perform activities with GMOs without the respective permits and authorizations;
p.(None): II. Perform activities with GMOs in breach of the terms and conditions established in the permits and
p.(None): respective authorizations;
p.(None): III. Perform activities of confined use of GMOs, without presenting the notices in the terms
p.(None): established in this Law;
p.(None): IV. Carry out activities with GMOs that are subject or exempt from the notice submission, in breach of the
p.(None): other provisions of this Law, its regulations and the official Mexican norms that derive therefrom,
p.(None): that are applicable to the activity in question or that are common to all activities in
p.(None): biosecurity matter;
p.(None): V. Present to the competent Secretariats, information and / or documentation referred to in this
p.(None): system that is false, including the one related to the possible risks that activities with GMOs could
p.(None): cause human health or biological diversity;
p.(None): SAW. Breaches the sanitary, monitoring, control and prevention measures indicated by those interested in the information
p.(None): and documentation provided to obtain the respective permits and authorizations, and those established by the
p.(None): Secretariats in their own permits and authorizations;
p.(None): VII. Breaches the control and response measures in case of emergency indicated by the interested parties
...
p.(None): the scientific technical committee of the SEMARNAT. For the formulation of the opinion, the scientific technical committee will evaluate
p.(None): the information and the elements available to the Federal Attorney for Environmental Protection, whether
p.(None): that work in the administrative file or those provided by the complainants, respectively, and
p.(None): determine, where appropriate, the existence of the damage. They will be competent to know about the actions of
p.(None): liability for damage to the environment or biological diversity in the terms of this
p.(None): Article, the district courts in civil matters, in accordance with the territorial jurisdiction established in the
p.(None): respective provisions.
p.(None): The administrative sanctions established in the previous Article shall apply without prejudice, where appropriate,
p.(None): of the corresponding penalties when the acts or omissions constituting violations of this Law, are also
p.(None): constitutive of crime in accordance with the applicable provisions of the Federal Criminal Code.
p.(None): 41 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 122.- They are additionally applicable to this Chapter regarding administrative responsibilities,
p.(None): the provisions of the Single Chapter of the Fourth Title of the Federal Law of Administrative Procedure, with the exception
p.(None): of article 70-A of said system.
p.(None): TITLE TENTH
p.(None): Review Resource
p.(None): ARTICLE 123.- The final resolutions issued in the administrative procedures on the occasion of the
p.(None): application of this Law, its regulations and the rules that derive from it, may be challenged by the
p.(None): affected by the appeal for review, within fifteen days following the date of its notification, or before
p.(None): the competent jurisdictional instances.
p.(None): The appeal for review will be filed directly with the Secretariat that issued the contested decision,
p.(None): who in his case, will grant his admission, and the granting or the denial of the suspension of the act appealed, taking turns
p.(None): the recourse to your superior in the same Secretariat for final resolution.
p.(None): ARTICLE 124.- As regards the other procedures related to the substantiation of the appeal for review to
p.(None): referred to in the previous article, the provisions of Title Six of the Federal Law of
p.(None): Administrative Procedure.
p.(None): TRANSITORY
p.(None): FIRST ARTICLE.- This Law shall enter into force within thirty business days of its publication in the
p.(None): Official Journal of the Federation.
p.(None): SECOND ARTICLE.- The competent Secretariats shall issue and publish in the Official Gazette of the Federation the
p.(None): notice formats referred to in this order, within twenty days following the approval of the
p.(None): themselves by the Federal Regulatory Improvement Commission.
p.(None): THIRD ARTICLE.- Once the formats referred to in the transitory article have been issued and published
p.(None): above, those interested in accordance with this Law have the obligation to submit notices, must do so
...
Social / Property Ownership
Searching for indicator property:
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p.(None): of multiplication or culture in vivo or in vitro, provided that these techniques do not involve the use of
p.(None): genetically modified organisms such as receptor or parental organisms;
p.(None): II. The use of in vitro fertilization techniques, conjugation, transduction, transformation or
p.(None): any other natural process and polyploid induction, provided that no acid molecules are used
p.(None): recombinant deoxyribonucleic (DNA) or genetically modified organisms;
p.(None): III. The production and process of medicines and drugs with GMOs generated from confined processes whose
p.(None): regulation corresponds to the General Health Law;
p.(None): IV. The sanitary control of derived products and the confined production processes in which GMOs intervene
p.(None): authorized under this Law, for human or animal use or consumption, which are subject to the provisions of
p.(None): the General Health Law and its regulations applicable to all products and processes;
p.(None): V. The human genome, the culture of stem cells of humans, the modification of human germ cells and
p.(None): the biosafety of hospitals, whose regulation corresponds to the General Health Law, and to the International Treaties
p.(None): in which the United Mexican States are a party;
p.(None): SAW. The collection and use of biological resources, whose regulation corresponds to the General Law
p.(None): of Ecological Balance and Protection of the Environment, the General Wildlife Law, and the Treaties
p.(None): Internationals in which the United Mexican States are a party, and
p.(None): VII. The intellectual property of biotechnological products and processes, which is the subject of the Property Law
p.(None): Industrial, Federal Law on Plant Varieties and International Treaties in which the United States
p.(None): Mexicans be part.
p.(None): ARTICLE 7.- The activities, organizations and products subject to the scope of this Law, will not require, in matters of
p.(None): biosecurity and safety, of other permits, authorizations, notices and, in general, requirements, procedures and
p.(None): restrictions than those established in this system.
p.(None): It is excepted from the provisions of the preceding paragraph:
p.(None): I. The measures that in the matter of general health correspond to adopt to the Secretariat of Health in the terms of
p.(None): the General Health Law and its regulations, except for the processing and issuance of
p.(None): authorizations regulated by this Law;
p.(None): II. The measures that in the matter of animal, vegetable and aquaculture health correspond to adopt to the Secretariat
p.(None): of Agriculture, Livestock, Rural Development, Fisheries and Food, under the terms of the Federal Health Law
p.(None): Animal, the Federal Plant Health Law, the Fishing Law, the Sustainable Rural Development Law, and
p.(None): of the other applicable provisions, and
p.(None): 6 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): III. The corresponding environmental measures to adopt to the Ministry of Environment and Natural Resources
p.(None): under the terms of the General Law of Ecological Balance and Environmental Protection, of the General Law
p.(None): of Wildlife, the General Law on Sustainable Forest Development and other applicable laws in that area,
p.(None): except for:
...
p.(None): II. New relevant scientific or technical information is available from which it follows that
p.(None): Possible risks identified are not those originally intended.
p.(None): The competent Secretariat may issue a resolution within two months. In case of not doing so, it
p.(None): will consider the reconsideration dismissed.
p.(None): ARTICLE 68.- The reconsideration referred to in the preceding article does not constitute any remedy or means of defense,
p.(None): and may be promoted by interested parties regardless of whether they enforce the means of challenge established in
p.(None): This Law against the resolution that affects them.
p.(None): CHAPTER VI
p.(None): From the Permit Review
p.(None): ARTICLE 69.- The corresponding Secretariat, at any time and on the basis of new information
p.(None): scientific or technical about the possible risks that GMOs can cause to public health or the environment
p.(None): and to biological diversity, they may review the permits granted and, where appropriate, suspend their effects or revoke
p.(None): said permits, in accordance with the procedures established by the regulations that derive from this
p.(None): Law, when considering as causes that:
p.(None): I. There is a change in the circumstances of the activities that may influence the outcome of the study of the
p.(None): assessment of possible risks on which the permit was based, or
p.(None): II. Have additional scientific or technical information that could modify any
p.(None): conditions, limitations or permit requirements.
p.(None): CHAPTER VII
p.(None): Confidentiality
p.(None): ARTICLE 70.- Those interested may clearly identify in their permit application, that information
p.(None): that should be considered confidential according to the industrial property or copyright regime. The
p.(None): Corresponding secretariat shall be subject to the provisions of the laws of the matter and shall refrain from ordering to register and
p.(None): to provide third parties with information and data that are protected by these laws.
p.(None): ARTICLE 71.- They shall not be confidential:
p.(None): I. The general description of GMOs;
p.(None): II. The identification of the interested party or person responsible for the activity;
p.(None): III. The purpose and place or places of the activity;
p.(None): 25 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Biosafety, monitoring, control and emergency systems and measures, and
p.(None): V. Studies on possible risks to human health or the environment and biological diversity.
p.(None): Access to the information referred to in the previous sections shall be governed, in addition, by the provisions
p.(None): applicable in matters of access to government public information.
p.(None): CHAPTER VIII
p.(None): Export of GMOs destined for release to the environment in other countries
p.(None): ARTICLE 72.- Those interested in exporting GMOs that are destined for their release to the environment in other countries, will notify
p.(None): by itself, as determined in the regulations that derive from this Law, its intention to
p.(None): export said organisms to the competent authorities of the respective country Such notification only
...
p.(None): same precept, in a period of two years, counted from the date on which the competent Secretariat determines
p.(None): by means of a definitive resolution the commission of the first infraction, and provided that this had not been
p.(None): distorted;
p.(None): III. Temporary or definitive closure, partial or total, of the facilities in which the
p.(None): infractions when:
p.(None): A) The infractions generate possible risks or adverse effects to human health or biological diversity or
p.(None): animal, vegetable or aquaculture health;
p.(None): B) The offender has not complied with the deadlines and conditions imposed by the Secretariats
p.(None): competent, with the security measures or urgently ordered, or
p.(None): C) It is a matter of repeated disobedience to the fulfillment of some or some security measures or urgent application
p.(None): imposed by the competent Secretariats;
p.(None): 40 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Confiscation of instruments, copies, organisms obtained or directly related products
p.(None): with the offenses committed;
p.(None): V. The suspension or revocation of permits and corresponding authorizations;
p.(None): SAW. Administrative arrest for up to thirty-six hours, and
p.(None): VII. Prohibition of experimental release, pilot program release or
p.(None): marketing of GMOs or the products that contain them.
p.(None): ARTICLE 121.- Regardless of the provisions of the preceding Article, any person who, with full knowledge of
p.(None): that these are GMOs, cause damage to third parties in their property or to their health, due to the improper use or handling of said
p.(None): agencies, will be responsible and will be obliged to repair them under the terms of federal civil legislation.
p.(None): The same obligation will be assumed by the person who damages the environment or biological diversity, due to improper use or handling
p.(None): of GMOs, for which the provisions of Article 203 of the General Law of Ecological Balance and the
p.(None): Environmental Protection
p.(None): Those directly affected in their property may request the judge to request the Secretariat
p.(None): competent so that, through its respective scientific technical committee that establishes according to this
p.(None): order, prepare a technical opinion whose purpose is to prove the existence of the damage, and serve as the basis for the judge
p.(None): to determine, where appropriate, the form of its repair. The technical opinion issued will not generate any cost to
p.(None): Applicants charge.
p.(None): In the case of damage to the environment or biological diversity, the SEMARNAT, through the
p.(None): Federal Attorney for Environmental Protection, will exercise the responsibility action, being able to do it in any
p.(None): in the following ways:
p.(None): I. Ex officio, based on the file relating to inspection and surveillance acts that have been finalized,
p.(None): the commission of infractions to this Law has been determined and this determination has not been distorted by any
p.(None): means of challenge, or
p.(None): II. By complaint, filed by members of the affected community, of acts that could contravene the
p.(None): established in this Law and other provisions that emanate from it. The complaint must be accompanied by the information
p.(None): technical and scientific support, with the participation of the Scientific Advisory Board of the CIBIOGEM,
p.(None): previous opinion of the National Commission for the Knowledge and Use of Biodiversity.
p.(None): In the cases referred to in the previous sections, the Federal Attorney General's Office
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CURRENT TEXT
p.(None): New Law published in the Official Gazette of the Federation on March 18, 2005
p.(None): On the margin a seal with the National Shield, which says: United Mexican States.- Presidency of the
p.(None): Republic.
p.(None): VICENTE FOX QUESADA, President of the United Mexican States, to its inhabitants know: May the Honorable Congress of
p.(None): the Union, has served to address the following
p.(None): DECREE
p.(None): "THE CONGRESS OF THE UNITED MEXICAN STATES, DECREE:
p.(None): THE BIOSEGURITY LAW OF GENETICALLY MODIFIED ORGANISMS IS ISSUED.
p.(None): SINGLE ARTICLE: The Law of Biosafety of Genetically Modified Organisms is issued, to read as follows:
p.(None): BIOSEURITY ACT OF GENETICALLY MODIFIED ORGANISMS FIRST TITLE
p.(None): General disposition
p.(None): CHAPTER I
p.(None): Object and Purposes
p.(None): ARTICLE 1.- This Law is of public order and of social interest, and is intended to regulate the activities of
p.(None): Confined use, experimental release, pilot program release, commercial release,
p.(None): marketing, import and export of genetically modified organisms, in order to prevent, avoid or
p.(None): reduce the possible risks that these activities could cause to human health or to the environment and to the
p.(None): biological diversity or animal, plant and aquaculture health.
p.(None): ARTICLE 2.- To fulfill its purpose, this order has the following purposes:
p.(None): I. Ensure an adequate and efficient level of protection of human health, the environment and diversity
p.(None): biological and animal, plant and aquaculture health, regarding the adverse effects that could
p.(None): cause them to carry out activities with genetically modified organisms;
p.(None): II. Define the principles and national policy on biosafety of GMOs and
p.(None): instruments for its application;
p.(None): III. Determine the powers of the various agencies of the Federal Public Administration in matters of
p.(None): Biosecurity of GMOs;
p.(None): IV. Establish the basis for concluding agreements or coordination agreements between the Federation,
p.(None): through the competent Secretariats and the governments of the federal entities, for the best compliance
p.(None): the purpose of this Law;
p.(None): 1 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): V. Establish the basis for the functioning of the Inter-Secretariat Biosafety Commission of the Organizations
p.(None): Genetically Modified, through which the Secretariats that integrate it must collaborate in a way
p.(None): coordinated, within the scope of its competences, in relation to the biosecurity of genetically engineered organisms
p.(None): modified;
p.(None): SAW. Establish administrative procedures and criteria for the evaluation and monitoring of
p.(None): possible risks that may be caused by activities with genetically modified organisms in human health or
p.(None): in the environment and biological diversity or in animal, plant or aquaculture health;
p.(None): VII. Establish the permit regime for carrying out experimental release activities, for release in
p.(None): pilot and commercial release program of genetically modified organisms, including the importation of
p.(None): those agencies to carry out these activities;
p.(None): VIII. Establish the system of notices for carrying out activities of confined use of
p.(None): genetically modified organisms, in the cases referred to in this Law;
p.(None): IX. Establish the authorization regime of the Ministry of Health of organizations
p.(None): genetically modified that are determined in this Law;
p.(None): X. Create and develop the National Biosafety Information System and the National Biosafety Registry of
p.(None): Genetically Modified Organisms;
p.(None): XI Determine the basis for the case-by-case establishment of GMO-free geographic areas where
p.(None): prohibits and those in which the performance of activities with certain genetically restricted organisms is restricted
p.(None): modified, as well as crops of which Mexico is the center of origin, especially corn, which will maintain a
p.(None): special protection regime;
p.(None): XII. To establish the bases of the content of the official Mexican norms regarding biosafety;
p.(None): XIII Establish control measures to guarantee biosecurity, as well as sanctions
p.(None): corresponding in cases of non-compliance or violation of the provisions of this Law, their
p.(None): Mexican regulations and official norms that derive from it;
p.(None): XIV Establish mechanisms for public participation in biosafety aspects of this Law,
p.(None): including access to information, participation of the private, social and productive sectors to
p.(None): through the CIBIOGEM Joint Consultative Council, and the public consultation on applications for the release of GMOs to
p.(None): environment, and
p.(None): XV. Establish instruments to promote scientific and technological research in biosafety and biotechnology.
p.(None): ARTICLE 3.- For the purposes of this Law, it is understood by:
p.(None): I. Accident: The involuntary release of genetically modified organisms during their
p.(None): use and that may involve, based on technical criteria, possible risks to human health or the environment
p.(None): Environment and biological diversity.
p.(None): II. Activities: Confined use, experimental release, pilot program release, release
p.(None): trade, marketing, import and export of genetically modified organisms, in accordance with
p.(None): this law.
p.(None): 2 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): III. Authorization: It is the administrative act through which the Ministry of Health, within the scope of its competence
p.(None): pursuant to this Law, authorizes genetically modified organisms expressly determined in this
p.(None): ordering, so that it can be carried out its commercialization and import for its commercialization, as well as its
p.(None): use for public health or bioremediation purposes.
p.(None): IV. Bioremediation: The process in which genetically modified microorganisms are used for
p.(None): degradation or disintegration of pollutants that affect resources and / or natural elements, in order to convert them into
p.(None): simpler components and less harmful or not harmful to the environment.
p.(None): V. Biosecurity: The actions and measures of evaluation, monitoring, control and prevention that must be assumed
p.(None): in carrying out activities with genetically modified organisms, in order to prevent, avoid or
p.(None): reduce the possible risks that such activities could cause to human health or the environment
p.(None): and biological diversity, including safety aspects of said organisms that are intended for use or consumption
p.(None): human.
p.(None): SAW. Modern biotechnology: The application of in vitro nucleic acid techniques, including acid, is understood
p.(None): recombinant deoxyribonucleic (DNA and RNA) and direct injection of nucleic acid into cells or organelles, or the
p.(None): cell fusion beyond the taxonomic family, which overcomes the natural physiological barriers of reproduction
p.(None): or recombination and that are not techniques used in traditional reproduction and selection, which are applied to
...
p.(None): based on the available scientific and technical evidence, considering, among other aspects, the
p.(None): recipient organism, the area of release and the characteristics of the genetic modification, as well as the background
p.(None): that exist on carrying out activities with the agency in question and the benefits
p.(None): compared to alternative technological options to contend with the specific problem.
p.(None): VIII. Center of origin: It is that geographical area of the national territory where the process of
p.(None): domestication of a particular species.
p.(None): IX. Center of genetic diversity: It is that geographical area of the national territory where there is
p.(None): morphological diversity, genetic or both of certain species, which is characterized by housing
p.(None): populations of wild relatives and that constitutes a genetic reserve.
p.(None): X. Marketing: It is the introduction to the market for distribution and consumption of genetically organisms
p.(None): modified as products or merchandise, without intentional release purposes
p.(None): environment and regardless of the profit motive and the legal title under which it is carried out.
p.(None): XI CIBIOGEM: The Inter-secretarial Commission of Biosafety of Genetically Modified Organisms.
p.(None): XII. CONACyT: The National Council of Science and Technology.
p.(None): XIII Biological diversity: The variability of living organisms from any source, including, among others
p.(None): things, terrestrial and marine ecosystems and other aquatic ecosystems and ecological complexes of
p.(None): those who are part; It includes the diversity within each species, between species and ecosystems.
p.(None): 3 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): XIV Safety: The sanitary evaluation of genetically modified organisms that are for use or consumption
p.(None): human or for food processing for human consumption, whose purpose is to ensure that such
p.(None): organisms do not cause risks or damage to the health of the population.
p.(None): XV. Release: The introduction into the environment of an organism or combination of organisms genetically
p.(None): modified, without containing containment measures, such as physical barriers or a combination thereof
p.(None): with chemical or biological barriers, to limit their contact with the population and the environment.
p.(None): XVI. Commercial liberation: It is the introduction, intentional and permitted in the environment, of a
p.(None): organism or combination of genetically modified organisms, without measures of
p.(None): containment, such as physical barriers or a combination of these with chemical or biological barriers, to limit
p.(None): its contact with the population and the environment, which is carried out for commercial, production,
p.(None): of bioremediation, industrial and any other than experimental release and the
p.(None): release in pilot program, in the terms and conditions contained in the respective permit.
p.(None): XVII Experimental release: It is the introduction, intentional and permitted in the environment, of an organism or
p.(None): combination of genetically modified organisms, provided containment measures have been taken, such as
p.(None): physical barriers or a combination of these with chemical or biological barriers, to limit your contact with the
p.(None): population and the environment, exclusively for experimental purposes, under the terms and conditions that
p.(None): contain the respective permission.
...
p.(None): XIX. Environment: The set of natural and artificial or man-induced elements that make possible the
p.(None): existence and development of human beings and other living organisms that interact in a space and time
p.(None): determined, outside the area of the facilities or the scope of the confined use of genetically engineered organisms
p.(None): modified.
p.(None): XX. Organism: Any living biological entity capable of reproducing or transferring or replicating material
p.(None): genetic, being included in this concept the sterile organisms, the
p.(None): microorganisms, viruses and viroids, whether or not cellular. Human beings should not be
p.(None): considered organisms for the purposes of this Law.
p.(None): XXI. Genetically modified organism: Any living organism, with the exception of human beings, which
p.(None): has acquired a novel genetic combination, generated through the specific use of biotechnology techniques
p.(None): modern that is defined in this Law, provided that techniques that are established in this Law or in the standards are used
p.(None): Mexican officers that derive from it.
p.(None): XXII. GMOs or GMOs: Genetically modified organism or organisms.
p.(None): XXIII. Step by step: Methodological approach according to which, any GMO that is destined to be released
p.(None): Commercially it must be previously submitted to satisfactory tests according to risk studies, evaluation
p.(None): of risks and reports of results applicable in the conduct of experimental release activities and
p.(None): release in pilot program of said organizations, in the terms of this Law.
p.(None): 4 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): XXIV Permission: It is the administrative act that corresponds to the SEMARNAT or SAGARPA, within the scope of their
p.(None): respective competences under this Law, necessary for the realization of the experimental release, the
p.(None): release in pilot program, commercial release and import of GMOs to perform these
p.(None): activities, in the cases and terms established in this Law and in the official Mexican norms that derive from it.
p.(None): XXV Products that contain genetically modified organisms: Are those that contain some or some
p.(None): Genetically modified organisms in their composition for commercialization.
p.(None): XXVI Derived products: Are those in which genetically modified organisms have intervened as
p.(None): inputs in their production process, including their extracts, provided they do not contain in their composition
p.(None): for marketing genetically modified living organisms and, therefore, do not have the capacity to
p.(None): transfer or replicate your genetic material.
p.(None): XXVII. Registry: The National Biosafety Registry of Genetically Modified Organisms.
p.(None): XXVIII. Waste: Any waste material generated in the confined use of genetically engineered organisms
p.(None): modified, including genetically modified organisms themselves.
p.(None): XXIX Secretariats: The Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food, the Secretariat of
p.(None): Environment and Natural Resources and the Ministry of Health, regarding their respective areas of
p.(None): competence established in this Law.
p.(None): XXX SAGARPA: The Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food.
p.(None): XXXI SEMARNAT: The Ministry of Environment and Natural Resources.
...
p.(None): the one that, thus modified, is cultivated, stored, used, processed, transported, commercialized, destroyed or
p.(None): eliminate, provided that physical barriers or a combination of these with
p.(None): chemical or biological barriers, in order to effectively limit their contact with the population and the environment
p.(None): environment. For the purposes of this Law the area of the facilities or the scope of the confined use does not form
p.(None): part of the environment.
p.(None): XXXV Authorized areas: The geographic areas or regions that are determined on a case by case basis in the resolution of a
p.(None): permission, in which genetically modified organisms that may have been released into the environment
p.(None): analyzed.
p.(None): XXXVI Restricted areas: Centers of origin, centers of genetic diversity and areas
p.(None): protected areas, within which the performance of activities with organisms is restricted
p.(None): genetically modified, in the terms of this Law.
p.(None): ARTICLE 4.- The subject of this Law is the biosecurity of all GMOs obtained or produced through the
p.(None): application of the techniques of modern biotechnology referred to in this ordinance, which
p.(None): be used for agricultural, livestock, aquaculture, forestry, industrial, commercial,
p.(None): bioremediation and any other, with the exceptions established by this Law.
p.(None): ARTICLE 5.- The authorization of GMOs that are intended for human use or consumption is also the subject of this Law.
p.(None): to the processing of food for human consumption, in order to carry out its
p.(None): 5 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): marketing and import for marketing. Likewise, the authorization of
p.(None): GMOs, other than the above, that are intended for public health purposes or bioremediation.
p.(None): ARTICLE 6.- The following are excluded from the scope of this Law:
p.(None): I. Activities of confined use, experimental release, pilot program release and
p.(None): Commercial release, commercialization, import and export of GMOs, when the genetic modification of
p.(None): such organisms are obtained by traditional mutagenesis or cell fusion techniques, including protoplasts
p.(None): of plant cells, in which the resulting organisms can also be produced by traditional methods
p.(None): of multiplication or culture in vivo or in vitro, provided that these techniques do not involve the use of
p.(None): genetically modified organisms such as receptor or parental organisms;
p.(None): II. The use of in vitro fertilization techniques, conjugation, transduction, transformation or
p.(None): any other natural process and polyploid induction, provided that no acid molecules are used
p.(None): recombinant deoxyribonucleic (DNA) or genetically modified organisms;
p.(None): III. The production and process of medicines and drugs with GMOs generated from confined processes whose
p.(None): regulation corresponds to the General Health Law;
p.(None): IV. The sanitary control of derived products and the confined production processes in which GMOs intervene
p.(None): authorized under this Law, for human or animal use or consumption, which are subject to the provisions of
p.(None): the General Health Law and its regulations applicable to all products and processes;
p.(None): V. The human genome, the culture of stem cells of humans, the modification of human germ cells and
...
p.(None): of Ecological Balance and Protection of the Environment, the General Wildlife Law, and the Treaties
p.(None): Internationals in which the United Mexican States are a party, and
p.(None): VII. The intellectual property of biotechnological products and processes, which is the subject of the Property Law
p.(None): Industrial, Federal Law on Plant Varieties and International Treaties in which the United States
p.(None): Mexicans be part.
p.(None): ARTICLE 7.- The activities, organizations and products subject to the scope of this Law, will not require, in matters of
p.(None): biosecurity and safety, of other permits, authorizations, notices and, in general, requirements, procedures and
p.(None): restrictions than those established in this system.
p.(None): It is excepted from the provisions of the preceding paragraph:
p.(None): I. The measures that in the matter of general health correspond to adopt to the Secretariat of Health in the terms of
p.(None): the General Health Law and its regulations, except for the processing and issuance of
p.(None): authorizations regulated by this Law;
p.(None): II. The measures that in the matter of animal, vegetable and aquaculture health correspond to adopt to the Secretariat
p.(None): of Agriculture, Livestock, Rural Development, Fisheries and Food, under the terms of the Federal Health Law
p.(None): Animal, the Federal Plant Health Law, the Fishing Law, the Sustainable Rural Development Law, and
p.(None): of the other applicable provisions, and
p.(None): 6 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): III. The corresponding environmental measures to adopt to the Ministry of Environment and Natural Resources
p.(None): under the terms of the General Law of Ecological Balance and Environmental Protection, of the General Law
p.(None): of Wildlife, the General Law on Sustainable Forest Development and other applicable laws in that area,
p.(None): except for:
p.(None): A) The environmental impact assessment and risk study regulated in Section V of Chapter IV of the Title
p.(None): First and in Chapter V of Title Four, of the General Law of Ecological Balance and Environmental Protection, and
p.(None): B) The processing and issuance of permits and other control and monitoring instruments that regulate
p.(None): this law.
p.(None): ARTICLE 8.- In the absence of express provision in this ordinance, the provisions of the Federal Law shall be followed.
p.(None): of Administrative Procedure.
p.(None): CHAPTER II
p.(None): Principles in Biosafety
p.(None): ARTICLE 9.- For the formulation and conduct of the biosafety policy and the issuance of regulations and
p.(None): of the official Mexican norms that derive from this Law, the following principles will be observed:
p.(None): I. The Mexican Nation has a biodiversity of the largest in the world, and its territory is
p.(None): find areas that are the center of origin and genetic diversity of species and varieties that must be
p.(None): protected, used, empowered and sustainably exploited, for being a valuable reservoir of wealth in
p.(None): molecules and genes for the sustainable development of the country;
...
p.(None): commercialization, importation and exportation of said organisms resulting from biotechnology
p.(None): modern that may have adverse effects for the conservation and sustainable use of the environment and the
p.(None): biological diversity, as well as human health and animal, plant and aquaculture health;
p.(None): IV. In order to protect the environment and biological diversity, the Mexican State must
p.(None): apply the precautionary approach according to their abilities, taking into account the commitments
p.(None): established in international treaties and agreements to which the United Mexican States are a party.
p.(None): When there is a danger of serious or irreversible damage, the lack of absolute scientific certainty should not be used as
p.(None): reason to postpone the adoption of cost-effective measures to prevent degradation
p.(None): of the environment and biological diversity. Such measures shall be adopted in accordance with the provisions and
p.(None): administrative procedures established in this Law;
p.(None): V. The protection of human health, the environment and biological diversity requires that attention be paid
p.(None): due to the control and management of the possible risks derived from the activities with GMOs, through an evaluation
p.(None): prior to said risks and the post-release monitoring;
p.(None): SAW. The knowledge, opinions and experience of scientists, particularly those of the country, constitute a
p.(None): valuable element of guidance for the regulation and administration of activities
p.(None): 7 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): with GMOs they are based on scientifically based studies and opinions, so it should be encouraged
p.(None): scientific research and technological development in biosafety and biotechnology;
p.(None): VII. In the confined use of GMOs for teaching, scientific research and
p.(None): technological, industrial and commercial, the provisions of this Law, its
p.(None): Mexican regulations and official norms that derive from it, as well as the norms and principles of prevention that
p.(None): establish the institutions, centers or companies, whether public or private, that carry out these activities;
p.(None): VIII. The possible risks that activities with GMOs could produce to human health and diversity
p.(None): Biological will be evaluated on a case-by-case basis. This evaluation will be based on the best scientific evidence and
p.(None): available technique;
p.(None): IX. The release of GMOs into the environment must be done "step by step" according to which, all GMOs
p.(None): that is intended to be released commercially must be previously subjected to satisfactory tests
p.(None): according to risk studies, risk assessment and reports of results applicable in the
p.(None): carrying out experimental release and pilot program release activities of said organizations, in the
p.(None): terms of this Law;
p.(None): X. Adverse effects that the release of GMOs could cause to biological diversity should be monitored,
p.(None): also taking into account the possible risks to human health;
p.(None): XI Administrative procedures to grant permits and authorizations to perform
p.(None): activities with GMOs must be effective and transparent; in the issuance of regulations and official standards
...
p.(None): alternates to contend with the specific problem for which the GMO was designed. Said comparative analysis
p.(None): It must be based on scientific and technical evidence, as well as background on use, production and consumption,
p.(None): and may be an additional element to the risk assessment study to decide, casuistically, on the
p.(None): release to the environment of the GMO in question;
p.(None): XIV Adequate capacity and regulations must be provided to prevent accidental release
p.(None): to the environment of GMOs coming from residues of any type of processes in which they have been used
p.(None): organisms;
p.(None): XV. The application of this Law, administrative procedures and criteria for the evaluation of possible
p.(None): risks that could be generated by the activities regulated by this Law, the control instruments of said activities, the
p.(None): monitoring of them, their regulations and the official Mexican norms that derive from it, the procedures of
p.(None): inspection and surveillance to verify and verify compliance with this Law and the provisions that
p.(None): they derive, the implementation of security measures and urgent application, and the application of
p.(None): sanctions for violations of the precepts of this Law and the provisions that emanate from it, are the form
p.(None): in which the Mexican State acts with caution, prudently and with scientific and technical bases to prevent,
p.(None): reduce or avoid the possible risks that activities with GMOs could cause to human health or to
p.(None): environment and biological diversity;
p.(None): 8 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): XVI. The biosecurity of agricultural, fishery and aquaculture products is
p.(None): closely related to plant, animal and aquaculture health, so the policy in these
p.(None): subjects should include environmental, biological diversity, human health and plant health aspects and
p.(None): animal;
p.(None): XVII The Mexican State will cooperate in the area of information exchange and research on the effects
p.(None): socioeconomic status of GMOs, especially in indigenous and local communities;
p.(None): XVIII. The Mexican State will guarantee public access to biosafety and biotechnology information to
p.(None): referred to in this Law, in accordance with the provisions of this system and the provisions applicable to the
p.(None): matter of access to government public information, and
p.(None): XIX. Experimentation with GMOs or with any other body for manufacturing and / or use purposes
p.(None): of biological weapons is prohibited in the national territory.
p.(None): CHAPTER III
p.(None): Of the Biosafety Competencies
p.(None): ARTICLE 10.- Are competent authorities in the field of biosafety:
p.(None): I. The SEMARNAT;
p.(None): II. SAGARPA, and
p.(None): III. SSA
p.(None): The SHCP will have the powers established in this Law, regarding the import of GMOs and
p.(None): of products that contain them.
p.(None): ARTICLE 11.- It corresponds to the SEMARNAT the exercise of the following faculties regarding activities with all types
p.(None): of GMOs, except in the case of GMOs that correspond to SAGARPA:
p.(None): I. Participate in the formulation and implementation of the general biosafety policy;
p.(None): II. Analyze and evaluate on a case-by-case basis the possible risks that activities with GMOs could
p.(None): cause the environment and biological diversity, based on risk studies and reports of
p.(None): results elaborated and presented by the interested parties, in the terms of this Law;
p.(None): III. Resolve and issue permits for carrying out activities for the release of GMOs into the environment, as well as
p.(None): establish and follow up on the conditions and measures to which these activities must be subject, according to
p.(None): the provisions of this ordinance, including the release of GMOs for bioremediation;
p.(None): IV. Monitor the effects that could be caused by the release of GMOs, permitted or
p.(None): accidental, to the environment and to biological diversity, in accordance with the provisions of this Law and the regulations
p.(None): Mexican officers derived from it;
p.(None): V. Participate in the preparation and issuance of the lists referred to in this Law;
p.(None): SAW. Suspend the effects of permits, when you have scientific and technical information from which it follows that
p.(None): the permitted activity involves risks higher than those expected, which may affect
p.(None): 9 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): negatively to the environment, biological diversity or human health or animal health,
p.(None): Vegetable or aquaculture These last two cases, at the express request of SAGARPA or the SSA, according to their competence
p.(None): in accordance with this Law, with support in technical and scientific elements;
p.(None): VII. Order and apply the relevant security or urgent application measures, with bases
p.(None): scientific and technical and in the precautionary approach, in the terms of this Law;
p.(None): VIII. Inspect and monitor compliance with this Law, its regulations and official Mexican standards that
p.(None): derive from it;
p.(None): IX. Impose administrative sanctions on people who violate the precepts of this Law, their
p.(None): Mexican regulations and official regulations that derive from it, without prejudice, where appropriate, of the penalties
p.(None): correspond when the acts or omissions constituting infractions to this system are also constitutive
p.(None): of crime, and of the civil and environmental responsibility that may result, and
p.(None): X. The others that this Law confers.
p.(None): ARTICLE 12.- It is the responsibility of SAGARPA to exercise the powers conferred on it by this Law, in the case of
p.(None): activities with GMOs in the following cases:
p.(None): I. Vegetables that are considered agricultural species, including seeds, and any other organism or product
p.(None): considered within the scope of the Federal Plant Health Law, with the exception of
p.(None): wild and forest species regulated by the General Wildlife Law and the General Forest Development Law
...
p.(None): Federal Animal Health Law, with the exception of wild species regulated by the General Life Law
p.(None): Wild and those that are under some protection regime by official Mexican standards
p.(None): derived from those laws;
p.(None): III. Phytozoosanitary and animal and plant nutrition inputs;
p.(None): IV. Fishing and aquaculture species, with the exception of those that are under some protection regime for
p.(None): official Mexican standards;
p.(None): V. GMOs used in immunization to protect and prevent the spread of
p.(None): animal diseases;
p.(None): SAW. GMOs that are fungi, bacteria, protozoa, viruses, viroids, spiroplasmas, phytoplasms, and others
p.(None): microorganisms, which have productive agricultural, livestock, aquaculture or phytozoosanitary purposes, and
p.(None): VII. In the other organizations and products determined by the regulations of this Law.
p.(None): ARTICLE 13.- In the cases established in the previous article, it is up to SAGARPA the exercise of
p.(None): The following attributions:
p.(None): I. Participate in the formulation and implementation of the general biosafety policy;
p.(None): II. Analyze and evaluate on a case-by-case basis the possible risks that activities with GMOs could
p.(None): cause animal, plant and aquaculture health, as well as the environment and biological diversity, based on
p.(None): the risk studies and the results reports that are elaborated and presented by the interested parties, in the terms of this
p.(None): Law;
p.(None): 10 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): III. Resolve and issue permits to carry out activities with GMOs, as well as establish and monitor
p.(None): the conditions and measures to which these activities must be subject, in accordance with the provisions of this
p.(None): ordering;
p.(None): IV. Monitor the effects that could be caused by the release of GMOs, permitted or
p.(None): accidental, to animal, plant and aquaculture health, and to biological diversity, in accordance with what they have
p.(None): this Law and the official Mexican norms that derive from it;
p.(None): V. Participate in the preparation and issuance of the lists referred to in this Law;
p.(None): SAW. Suspend the effects of permits, when you have scientific and technical information
p.(None): supervening from which it is deduced that the permitted activity entails higher risks than expected, which may
p.(None): negatively affect animal, plant or aquaculture health, biological diversity or human health. These two
p.(None): last cases, at the express request of the SEMARNAT or the SSA, depending on their competence under this Law, with
p.(None): support in technical and scientific elements;
p.(None): VII. Order and apply the relevant security or urgent application measures, with technical bases and
p.(None): scientific and in the precautionary approach, in the terms of this Law;
p.(None): VIII. Inspect and monitor compliance with this Law, its regulations and official Mexican standards that
p.(None): derive from it;
p.(None): IX. Impose administrative sanctions on people who violate the precepts of this Law, their
p.(None): Mexican regulations and official regulations that derive from it, without prejudice, where appropriate, of the penalties
p.(None): correspond when the acts or omissions constituting infractions to this system are also constitutive
...
p.(None): X. The others that this Law confers.
p.(None): ARTICLE 14.- In the cases in which SEMARNAT is responsible for the knowledge, processing and resolution of a
p.(None): permission application, in the case of wild and forest species, you must send the respective file to the
p.(None): SAGARPA to issue the corresponding opinion.
p.(None): ARTICLE 15.- In cases that fall within the competence of SAGARPA, SEMARNAT will
p.(None): The following will apply:
p.(None): I. Issue the corresponding biosafety opinion, prior to the resolution of SAGARPA, as a result of the
p.(None): analysis and evaluation of risks that you carry out based on the study developed and presented by the
p.(None): interested, about the possible risks that the activity with GMOs in question may cause to the environment and
p.(None): biological diversity, in the case of applications for permits for experimental release of said organisms, or
p.(None): based on the results reports and the information that the interested parties attach to their requests for
p.(None): permits for release in pilot program and for commercial release;
p.(None): II. Require SAGARPA to suspend the effects of the permits issued by said Secretariat, when available
p.(None): of scientific and technical information from which it is deduced that the permitted release involves risks
p.(None): higher than expected that may adversely affect the environment and biological diversity, and
p.(None): III. The exercise of the powers established in sections I, II, IV, V, VII and VIII of article 11 of this
p.(None): Law.
p.(None): 11 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): The biosafety opinion referred to in section I of this article shall be binding, prior to
p.(None): granting of the corresponding permits to be issued to SAGARPA, and will be issued in the terms of article 66 of
p.(None): this law.
p.(None): ARTICLE 16.- It is the responsibility of the SSA to exercise the following powers in relation to GMOs:
p.(None): I. Participate in the formulation and implementation of the general biosafety policy;
p.(None): II. Evaluate on a case-by-case basis the studies prepared and presented by stakeholders on safety and possible
p.(None): risks of GMOs subject to authorization under the terms of Title Five of this Law;
p.(None): III. Resolve and issue the authorizations of GMOs referred to in the previous section;
p.(None): IV. Participate in the preparation and issuance of the lists referred to in this Law;
p.(None): V. Order and apply the relevant security or urgent application measures, with technical and scientific basis and
p.(None): in the precautionary approach, in the terms of this Law;
p.(None): SAW. Request from SEMARNAT or SAGARPA, as appropriate, with support from technical and scientific elements, the
p.(None): suspension of the effects of the release of GMOs to the environment, when available
p.(None): information from which it is deduced that the activity permitted by these Secretariats involves risks greater than
p.(None): expected to affect human health;
p.(None): VII. Inspect and monitor compliance with this Law, its regulations and official standards
p.(None): Mexican
p.(None): VIII. Impose administrative sanctions on people who violate the provisions of this Law, its regulations and
p.(None): Mexican official norms that derive from this Law, without prejudice, where appropriate, of the corresponding penalties when the
p.(None): acts or omissions constituting violations of this system are also constitutive of crime, and of the
p.(None): civil liability that may result, and
p.(None): IX. The others that this Law confers.
p.(None): The SSA will carry out the actions of sanitary and epidemiological surveillance of GMOs and the products that
p.(None): contain and derived products, in accordance with the General Health Law and its provisions
p.(None): Regulatory
p.(None): ARTICLE 17.- In case of accidental release of GMOs, the Secretariats will coordinate so that, within the scope of their
p.(None): respective powers in accordance with this Law, impose the necessary measures to avoid negative effects on the
p.(None): biological diversity, to human health or to animal, plant and aquaculture health, as appropriate.
p.(None): ARTICLE 18.- It corresponds to the SHCP the exercise of the following faculties, with respect to the import
p.(None): of GMOs and products containing them:
p.(None): I. Check in the customs of entry of the national territory, that the GMOs that are imported and destined for their release
p.(None): to the environment or for the purposes established in article 91 of this Law, have the permission and / or authorization
p.(None): respectively, as the case may be in the terms of this system;
p.(None): II. Check that the documentation that accompanies the GMOs that are imported into the country, contains the requirements of
p.(None): identification established in the official Mexican norms that derive from this Law;
p.(None): 12 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): III. Participate, jointly with the Secretariats, in the issuance of official Mexican standards related to
p.(None): storage or storage of GMOs or products containing them in the customs premises of the
p.(None): National territory;
p.(None): IV. Give immediate notice to SEMARNAT, SAGARPA and / or SSA, about the probable commission of violations of
p.(None): precepts of this Law, regarding the import of GMOs, and
p.(None): V. Prevent the entry into the national territory of GMOs and products containing them, in cases where such
p.(None): organisms and products do not have permission and / or authorization, as appropriate, for importation, pursuant to this
p.(None): Law.
p.(None): The SHCP will exercise the previous powers, without prejudice to those conferred by customs legislation,
p.(None): applicable to the import of all merchandise.
p.(None): CHAPTER IV
p.(None): Coordination and Participation
p.(None): ARTICLE 19.- The CIBIOGEM is an Intersecretarial Commission whose purpose is to formulate and coordinate the
p.(None): Federal Public Administration policies related to the biosafety of GMOs, which will have the functions
p.(None): that establish the regulations that derive from this Law, in accordance with the following bases:
p.(None): I. The CIBIOGEM will be integrated by the head of the Secretariats of Agriculture, Livestock, Development
p.(None): Rural, Fishing and Food; Environment and Natural Resources; Health; Public education; Treasury and
p.(None): Public Credit, and Economy, as well as by the General Director of CONACyT;
p.(None): II. The CIBIOGEM will have a Presidency that will be rotating among the holders of the Secretariats of Agriculture,
...
p.(None): a Vice Presidency whose head will be the General Director of CONACyT, who will chair the sessions
p.(None): in the absence of the President, he will assist the Commission and the Executive Secretary in the exercise of their
p.(None): functions and will carry out the activities entrusted to it by CIBIOGEM itself in the terms established by the
p.(None): regulatory provisions derived from this Law;
p.(None): III. CIBIOGEM may invite other agencies to participate, with voice, in agreements and decisions
p.(None): of matters related to its purpose, as well as to the members of the Advisory Council;
p.(None): IV. The CIBIOGEM will have an Executive Secretary who will be appointed by the President of the
p.(None): Republic, at the proposal of the General Director of CONACyT, approved by CIBIOGEM itself. It will have the powers and
p.(None): powers that are determined in the regulatory provisions that derive from this system, and will execute and give
p.(None): follow up on the agreements of the Commission itself and exercise the other functions entrusted to it;
p.(None): V. The Executive Secretariat of the CIBIOGEM will have the organic structure approved in the terms of the
p.(None): applicable provisions, and will be considered an administrative unit by function of CONACyT, in accordance with
p.(None): the Organic Law of said parastatal entity, and
p.(None): SAW. The CIBIOGEM will also have a Technical Committee composed of coordinators, general directors or
p.(None): competent equivalents in the matter designated by the heads of the dependencies and entities that form
p.(None): part of the CIBIOGEM. Said Committee may propose the creation of subcommittees.
p.(None): 13 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): specialized for the attention of specific matters and will have the attributions that are determined in the dispositions
p.(None): regulations that derive from this Law.
p.(None): ARTICLE 20.- The Scientific Advisory Council of the CIBIOGEM is created, which will function as a mandatory consultation body
p.(None): of CIBIOGEM itself in technical and scientific aspects in modern biotechnology and biosafety of GMOs. I know
p.(None): integrate by a group of experts in different disciplines, from centers, institutions of
p.(None): research, academies or scientific societies of recognized prestige, which will exercise their function to
p.(None): personal title, regardless of the institution, association or company of which they are part or in
p.(None): the one that provide their services. These experts will expressly express in commitment letter, at the time of being
p.(None): designated as members of the Scientific Advisory Board, not having any conflict of interest.
p.(None): The selection of the members of the Scientific Advisory Board will be made through a public call issued
p.(None): jointly the CONACyT and the Scientific and Technological Consultative Forum foreseen in the Law of Science and Technology.
p.(None): Among the functions of the Advisory Council, the formulation of research protocols, analysis and
p.(None): methodologies and technical opinions, which may be remunerated. The specific functions of the Advisory Council
p.(None): and the mechanisms so that the renewal of its members is progressive and staggered, will be established in the
p.(None): regulatory provisions derived from this Law. The technical opinions issued by the Council
p.(None): Scientific Consultant should be considered by the CIBIOGEM in the decisions adopted.
...
p.(None): participation so that members and representatives of the academic, scientific, technological, social and
p.(None): productive, of recognized prestige and experience in the subjects directly related to the
p.(None): activities that are the subject of this Law, may participate through opinions, studies and consultations in the
p.(None): knowledge and evolution of biosafety policies and promotion of biosafety research and
p.(None): biotechnology, as well as to receive opinions, studies and consultations in these matters.
p.(None): ARTICLE 23.- CONACyT will have in its budget the necessary resources for the development of the
p.(None): activities of the CIBIOGEM, the Executive Secretariat and the Scientific Advisory Board, in accordance with
p.(None): budget authorized under the terms of the applicable provisions. These resources will be
p.(None): administered and exercised by the Executive Secretary of the CIBIOGEM.
p.(None): The programs, projects, supports, as well as the other actions that are carried out by the application of
p.(None): the present Law and other provisions in the matter, in which federal resources are exercised, are
p.(None): subject to the availability of resources determined for this purpose in the Expenditure Budget
p.(None): of the Federation of the corresponding fiscal year, and must observe the applicable provisions in
p.(None): budgetary matter
p.(None): ARTICLE 24.- The Secretariats may establish scientific technical committees that provide support in the
p.(None): resolution of applications for permits and authorizations, as well as notices. The
p.(None): Regulatory provisions of this Law shall determine the basis for the organization and operation of said
p.(None): committees
p.(None): 14 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): CHAPTER V
p.(None): Of the Coordination with the Federative Entities
p.(None): ARTICLE 25.- The Federation, through the Secretariats within the scope of its competence and in the terms of the
p.(None): applicable provisions, with the knowledge of the CIBIOGEM, may conclude agreements or agreements of
p.(None): coordination with the governments of the federal entities, in order to:
p.(None): I. Establish concurrent collaboration in monitoring the risks that could be caused by the activities of
p.(None): release of GMOs to the environment, whether experimental or in a pilot program, determined in said
p.(None): agreements or agreements, and
p.(None): II. Where appropriate, in carrying out actions to monitor compliance with the provisions of this Law.
p.(None): ARTICLE 26.- The agreements or coordination agreements signed by the Federation with the governments of
p.(None): The federative entities for the purposes referred to in the previous article must comply with the
p.(None): applicable provisions and to the following bases:
p.(None): I. They will define precisely the subjects and activities that constitute the object of the agreement or agreement;
p.(None): II. The purpose of the agreements or agreements must be consistent with the policy regarding
p.(None): biosecurity;
p.(None): III. The assets and resources provided by the parties will be described, clarifying their destination.
p.(None): specific and its form of administration, for which the Federation will contribute to the strengthening of its capabilities
p.(None): financial and institutional;
p.(None): IV. The necessary means, procedures and resources provided by the Secretariats will be determined
p.(None): competent, so that the governments of the federal entities can carry out the
p.(None): actions and activities subject to coordination agreements or agreements;
p.(None): V. The validity of the agreement or agreement, its forms of termination and dispute resolution and,
p.(None): where appropriate, extension;
p.(None): SAW. Define the body or bodies that will carry out the actions resulting from the agreements or agreements of
p.(None): coordination;
p.(None): VII. They will determine the actions to promote and participate jointly in supporting the
p.(None): scientific and technological research in biosafety and biotechnology;
p.(None): VIII. The obligation to submit detailed reports on compliance with the object of the agreements and
p.(None): coordination agreements, and
p.(None): IX. They will contain the other stipulations that the parties consider necessary for the correct fulfillment
p.(None): of the agreement or agreement.
p.(None): The agreements referred to in this article must be published in the Official Gazette of the Federation
p.(None): and in the official dissemination body of the respective local government.
p.(None): ARTICLE 27.- The governments of the federal entities will have permanent access to the information that is
p.(None): register in the National Biosafety Registry of Genetically Organized Organisms
p.(None): 15 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): Modified Likewise, the CIBIOGEM, through its Executive Secretariat, will notify the applications for permits from
p.(None): commercial release to the environment of GMOs, to the governments of the federal entities in which it is intended
p.(None): carry out this activity, so that they have knowledge of that situation and can issue their
p.(None): opinions in the terms of this Law. The notification must be made within twenty days following
p.(None): that in which the CIBIOGEM has received the corresponding permit application for registration in the Registry.
p.(None): CHAPTER VI
p.(None): From the Promotion to Scientific and Technological Research in Biosafety and Biotechnology
p.(None): ARTICLE 28.- The Federal Executive shall promote, support and strengthen scientific research and
p.(None): technology in biosafety and biotechnology through policies and instruments
p.(None): established in this Law and in the Law of Science and Technology. In biotechnology, these supports will be oriented
p.(None): to promote research and development and innovation projects, human resources training
p.(None): specialized and strengthening of groups and infrastructure of universities, education institutions
p.(None): superior and public research centers, which are carried out to solve productive needs
p.(None): country-specific and that directly benefit national producers.
p.(None): In the field of biosafety, research will be encouraged to obtain sufficient knowledge to assess
p.(None): the possible risks of GMOs in the environment, biological diversity, human health and animal health,
p.(None): vegetable and aquaculture; to generate socio-economic considerations of the effects of these organisms for the
...
p.(None): for risk assessment and monitoring.
p.(None): ARTICLE 29.- To achieve the promotion of scientific and technological research in the field of
p.(None): Biosafety and biotechnology will establish a program for the development of biosafety and biotechnology
p.(None): which will be considered as a program whose formulation will be in charge of CONACyT based on the proposals that
p.(None): present the Secretariats and other agencies and entities of the Federal Public Administration that support or
p.(None): carry out scientific research and technological development. In this process opinions will be taken into account
p.(None): and proposals of the scientific, academic, technological and productive sector communities, convened by the Forum
p.(None): Scientific and Technological Consultant, and of the CIBIOGEM.
p.(None): Said program will be part of the Special Program of Science and Technology established by the Law of Science and
p.(None): Technology.
p.(None): ARTICLE 30.- The program for the development of biosafety and biotechnology must contain, at least,
p.(None): diagnoses, policies, strategies and general and sectoral actions regarding:
p.(None): I. Scientific research;
p.(None): II. Innovation and technological development;
p.(None): III. Training of researchers, technologists and high level professionals;
p.(None): IV. Support to public research centers;
p.(None): V. Scientific research projects and solution-oriented innovation and technological development
p.(None): of national problems and activities that benefit the agricultural producers,
p.(None): forestry and aquaculture of the country;
p.(None): 16 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): SAW. New research and technology transfer centers in primary areas of national development, of
p.(None): according to local or regional needs for environmental conservation and protection or forestry production,
p.(None): agricultural and industrial;
p.(None): VII. Dissemination of scientific and technological knowledge;
p.(None): VIII. National and international collaboration;
p.(None): IX. Strengthening the biosafety culture, and
p.(None): X. Decentralization and regional development.
p.(None): The Federal Executive, through the competent Secretariats, will make sure to make available to
p.(None): the seed companies of farmers 'and producers' organizations, preferably and
p.(None): accessible, the results of scientific research and innovation and technological development contained in the
p.(None): Program for the development of biosafety and biotechnology.
p.(None): ARTICLE 31.- CONACyT will constitute a Fund for the Promotion and Support of Scientific Research and
p.(None): Technology in Biosafety and Biotechnology in accordance with the Law of Science and Technology, to which the
p.(None): fiscal resources provided by the agencies and entities for this purpose, third party resources and income that
p.(None): The concept of rights determines the tax provisions, which derive from acts carried out in application of this Law.
p.(None): SECOND TITLE
p.(None): Permissions
p.(None): CHAPTER I
p.(None): Common Provisions
p.(None): ARTICLE 32.- The following activities will be required for permission:
p.(None): I. The experimental release into the environment, including the importation for that activity, of one or more GMOs;
p.(None): II. The release into the environment in a pilot program, including the import for that activity, of GMOs,
p.(None): Y
p.(None): III. The commercial release to the environment, including the import for that activity, of GMOs.
p.(None): ARTICLE 33.- Once the corresponding Secretariats receive a request for permission to release to the environment
p.(None): of GMOs, and as long as it complies with the information and requirements established in this Law, they must
p.(None): send it to the Registry for their respective registration and publicity. Once the above is done, the Secretariat
p.(None): to which it corresponds to resolve the request for the release of GMOs to the environment, will put
p.(None): public provision of said request, for public consultation, and must observe the forecasts on
p.(None): confidentiality established in this Law. Said Secretariat may make use of the means it deems
p.(None): suitable for the purpose of making the respective permit application available to the public.
p.(None): Any person, including the governments of the federal entities in which it is intended to carry out the
p.(None): respective release, may express their opinion, which must be supported by technical and
p.(None): 17 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): scientifically, within a period of no more than twenty business days from the date on which the
p.(None): respective request be made available to the public in the terms of this article.
p.(None): Opinions that are issued in accordance with the provisions of the preceding paragraph will be considered
p.(None): by the corresponding Secretariats for the establishment of additional biosecurity measures, in case
p.(None): it is appropriate to issue the release of GMOs to the corresponding environment, in the terms of this Law.
p.(None): ARTICLE 34.- The corresponding Secretariat shall issue its resolution, duly founded and motivated, once
p.(None): analyzed the information and documentation provided by the interested party, the opinion or opinion they had issued
p.(None): the Secretariats that are responsible for issuing them in accordance with this Law and, where appropriate, the
p.(None): GMO authorization issued by the SSA under the terms of this system. The corresponding Secretariat
p.(None): in its resolution you can:
p.(None): I. Issuing the permit for carrying out the release activity to the environment in question,
p.(None): being able to establish additional monitoring, control, prevention and security measures to those proposed by
p.(None): the interested party in the permit application, or
p.(None): II. Deny permission in the following cases:
p.(None): A) When the request does not comply with the provisions of this Law or the official Mexican regulations such as
p.(None): requirements for the granting of the permit;
...
p.(None): negatively affect human health or biological diversity, or animal, plant or aquaculture health,
p.(None): may cause serious or irreversible damage.
p.(None): ARTICLE 35.- The deadlines established in this Law for the resolution of a request for a release permit at
p.(None): GMO environment, whether experimental or pilot program, will be extendable, in case the interested party does not count
p.(None): with the authorization issued by the SSA in the terms of this ordinance, as long as said
p.(None): authorization is required for the issuance of the respective permit.
p.(None): ARTICLE 36.- The permits for experimental release, in the pilot or commercial program of GMOs to the environment, will be supplied
p.(None): effects of import permits of said organisms to be released experimentally, in
p.(None): pilot or commercial program, as the case may be, under the terms and conditions established in the own
p.(None): permissions The foregoing, notwithstanding that the import of the GMOs in question, is subject to the regime
p.(None): phytosanitary or aquaculture established in the corresponding legislation of the matter.
p.(None): ARTICLE 37.- The monitoring, prevention, control and safety measures of the possible risks of using the
p.(None): GMO established by the corresponding Secretariat in the permits, may include, among others, the following
p.(None): aspects:
p.(None): I. Management of the GMO;
p.(None): II. Safety measures so that the possible risk remains within the tolerance limits accepted in the
p.(None): evaluation, and
p.(None): 18 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): III. Monitoring of the activity in question, in relation to the possible risks that such activity could
p.(None): generate.
p.(None): ARTICLE 38.- The Secretariat that issues the permit may modify the monitoring, control and
p.(None): prevention, require the interested party to implement new measures, as well as suspend or revoke said permit,
p.(None): prior hearing granted to interested parties, when available scientific or technical information of the
p.(None): It follows that the activity may involve higher or lower risks than originally provided for
p.(None): the corresponding studies. The foregoing must be established in the permits issued by the Secretariats
p.(None): competent.
p.(None): ARTICLE 39.- The permit holder shall be obliged to observe and comply with the monitoring, prevention,
p.(None): control and security established by the permit, as well as the provisions of this system, its
p.(None): Mexican regulations and official norms that derive from it, that are applicable to the release
p.(None): concerned. Failure to comply with the measures and provisions referred to in this article will give
p.(None): place for the determination of the respective responsibility and the application of the corresponding sanctions according
p.(None): this law.
p.(None): ARTICLE 40.- The importation of GMOs or products containing them into the territory will not be allowed
p.(None): national, in cases where such organizations are prohibited in the country of origin or are found
p.(None): classified in the lists as not allowed for commercial release or for importation for that
p.(None): exercise.
p.(None): ARTICLE 41.- It is prohibited to carry out activities with GMOs or with any other body whose purpose is
p.(None): the manufacture and / or use of biological weapons.
p.(None): CHAPTER II
p.(None): Requirements for Obtaining Permits
p.(None): SECTION I
p.(None): Permission for experimental release to the environment
p.(None): ARTICLE 42.- The application for permission to perform the experimental release to the environment of GMOs,
p.(None): including its importation for that activity, it must be accompanied by the following information:
p.(None): I. Characterization of the GMO, which should consider what the official regulations establish for each case
p.(None): Mexicans that derive from this Law;
p.(None): II. The identification of the area where the GMO is intended to be experimentally released, including the specification of
p.(None): the total area on which the release will take place;
p.(None): III. A study of the possible risks that the release of GMOs could generate to the environment
p.(None): and to biological diversity. In addition, in cases that fall within the competence of SAGARPA, the study must
p.(None): contain what is related to the possible risks that the release of these organisms could cause to the
p.(None): animal, vegetable or aquaculture health;
p.(None): IV. The measures and procedures for monitoring activity and biosafety, which will be carried out at the time of
p.(None): carry it out and post-release ones;
p.(None): V. Where appropriate, the history of release of the GMOs concerned in other countries;
p.(None): 19 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): SAW. Where appropriate, considerations on the risks of the technological alternatives that are available will be presented.
p.(None): to contend with the problem for which the genetically modified organism that is intended to be released was constructed,
p.(None): Y
p.(None): VII. The information that for each case determines the official Mexican norms that derive from this Law.
p.(None): It will be a requirement to obtain the experimental release permit to the environment, which the applicant has
p.(None): with the authorization of the GMO issued by the SSA in accordance with this Law, when said agency has
p.(None): Public health purposes or be destined to bioremediation. The interested party may start the process
p.(None): to obtain such permission before the competent Secretariat, but it will not be granted until it is accredited in the
p.(None): respective file have obtained the authorization of the SSA.
p.(None): ARTICLE 43.- Those interested in importing GMOs for experimental release into the environment, in addition to the
p.(None): established in the previous article, they must attach to their request the information and documentation that
p.(None): prove that the GMO is allowed under the legislation of the country of origin, for its release, at least, in
p.(None): experimental stage, attaching for this purpose the authorization or official documentation that covers said
p.(None): situation.
p.(None): ARTICLE 44.- The resolution to a request for permission for experimental release of GMOs shall be
p.(None): be issued within a maximum period of six months from the day following that in which the Secretariat must
p.(None): To resolve has received the permit application and the information provided by the interested party is complete.
p.(None): ARTICLE 45.- In the event that, after the granting of the permit, in the realization of the release
p.(None): Experimental of a GMO into the environment the following is presented:
p.(None): I. There is any modification in the release that may increase or decrease the possible risks to the
p.(None): environment and biological diversity, or
p.(None): II. New scientific and technical information on these risks is available.
p.(None): In these cases, the permit holder will be obliged to:
p.(None): A. Inform the corresponding Secretariat immediately of this situation;
p.(None): B. Review the monitoring and biosafety measures specified in the documentation, and
p.(None): C. Adopt the necessary biosafety measures.
p.(None): ARTICLE 46.- The holder of the experimental release permit to the environment must inform the
p.(None): Secretariat that issued it, through a report, the results of the release (s) made in
p.(None): relationship with the possible risks to the environment and biological diversity. The characteristics and content of
p.(None): The report referred to in this article will be established in the official Mexican regulations derived from this Law.
p.(None): ARTICLE 47.- The permit holder shall be obliged to inform the Secretariat immediately.
p.(None): corresponding, any situation that in the realization of the permitted release, could increase or decrease
p.(None): the possible risks to the environment, biological diversity and / or human health.
p.(None): ARTICLE 48.- The corresponding Secretariat may limit the validity of the release permit.
p.(None): Experimental to the environment considering the elements of the file.
p.(None): 20 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 49.- The experimental releases to the environment of GMOs will be made under cover and in accordance with
p.(None): the terms and conditions established by the permit. In the event that such permission includes the
p.(None): realization of various releases of the same GMO in the same geographical area established in the permit, in
p.(None): the same may establish the requirement of notice of each release.
p.(None): SECTION II
p.(None): Permission for release to the environment in pilot program
p.(None): ARTICLE 50.- The application for permission to release GMOs into the environment in a pilot program, including
p.(None): its import for that activity, must be accompanied by the following information:
p.(None): I. The permission for the experimental release of the GMO in question;
p.(None): II. Reference and considerations on the report of the results of the release (s)
p.(None): Experimental carried out in relation to the possible risks to the environment and biological diversity
p.(None): and, additionally, to animal, plant or aquaculture health in cases that fall within the competence of SAGARPA in accordance with
p.(None): this law;
p.(None): III. Information related to:
p.(None): A) The total amount of the GMO to be released;
p.(None): B) The driving conditions that will be given to the GMO, and
p.(None): C) Identification of the areas where the GMO is intended to be released, including the specification of the surface or
p.(None): total areas on which the release will take place.
p.(None): IV. The monitoring and biosafety measures to be carried out during the release and after said activity, and
p.(None): V. The information that for each case determines the official Mexican norms that derive from this Law.
p.(None): The foregoing, in order that the corresponding Secretariats have the information to carry out the
p.(None): analysis and evaluation of possible risks to the environment and biological diversity or to animal health,
p.(None): vegetable or aquaculture, as appropriate according to this Law.
p.(None): It will be a requirement to obtain the permit for release to the environment in a pilot program, that the applicant has the
p.(None): authorization of the GMO issued by the SSA in accordance with this Law, when said agency is for use
p.(None): or human consumption The interested party may initiate the process to obtain said permission from the Secretariat
p.(None): competent, but will not be granted until you prove in the respective file to have obtained the
p.(None): SSA authorization.
p.(None): ARTICLE 51.- Those interested in importing GMOs for their release into the pilot program environment, in addition to the
p.(None): established in the previous article, they must attach to their request the information and documentation that
p.(None): prove that the GMO is allowed under the legislation of the country of origin, for its release, at least, in
p.(None): this stage class, attaching for that purpose the authorization or official documentation that covers said
p.(None): situation.
p.(None): ARTICLE 52.- The resolution to a request for permission to release GMOs into the pilot program
p.(None): must be issued within a maximum period of three months from the day following
p.(None): 21 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): the one in which the Secretariat to resolve has received the permit application and information
p.(None): provided by the interested party is complete.
p.(None): The validity of the permit will be determined considering the elements of the file.
p.(None): ARTICLE 53.- The holder of the permit for release to the environment in a pilot program must inform the Secretariat that
p.(None): it was issued by means of a report, the results of the release (s) made in relation to the possible
p.(None): risks to the environment and biological diversity. The characteristics and content of the report referred to
p.(None): This article will be established in the official Mexican norms that derive from this Law.
p.(None): ARTICLE 54.- The permit holder shall be obliged to immediately inform the Secretariat
p.(None): corresponding, any situation that in the realization of the permitted release, could increase or decrease
p.(None): the possible risks to the environment, biological diversity and / or human health.
p.(None): SECTION III
p.(None): Permission for commercial release to the environment
p.(None): ARTICLE 55.- The application for permission to carry out the commercial release to the environment of GMOs, including their
p.(None): import for that activity, must be accompanied by the following information:
p.(None): I. Permits for experimental and pilot program release of the GMO in question;
p.(None): II. Reference and considerations on the reports of the results of the experimental release and the release in
p.(None): pilot program that has been carried out, in terms of the permits referred to in the previous section;
p.(None): III. Specific instructions or recommendations for storage, transport and, where appropriate, handling;
p.(None): IV. Where applicable, conditions for release and commercialization;
p.(None): V. Where appropriate, considerations on the risks of the technological alternatives that are available will be presented
p.(None): to contend with the problem for which the GMO that was intended to be released was built;
p.(None): SAW. Where appropriate, the information available to the applicant on data or results of the
p.(None): marketing of the same GMO in other countries, and
p.(None): VII. The other information determined by the official Mexican regulations derived from this Law.
p.(None): The foregoing, in order that the corresponding Secretariats have the information to carry out the
p.(None): analysis and evaluation of possible risks to the environment and biological diversity or to animal health,
p.(None): vegetable or aquaculture, as appropriate according to this Law.
p.(None): ARTICLE 56.- Those interested in importing GMOs for commercial release, in addition to what is established in
p.(None): in the previous article, they must attach the information and documentation proving that the GMO is allowed according to
p.(None): the legislation of the country of origin for its commercialization, attaching for this purpose the authorization or
p.(None): official documentation that covers this situation.
p.(None): ARTICLE 57.- The resolution to a request for permission for commercial release to the environment must
p.(None): be issued within four months from the day following that in which the
p.(None): 22 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): Secretariat to be resolved has received the permit application and the information provided by the
p.(None): interested be complete.
p.(None): ARTICLE 58.- The activities and imports subsequent to the commercial release permit to the environment will be carried out
p.(None): subject to the terms and conditions established therein, and without requiring successive permits. I know
p.(None): understand that subsequent imports are made under the same terms and conditions established in the
p.(None): respective commercial release permit, in the case of the same GMO and the same release area. The above,
p.(None): regardless of whether such activities and imports may be subject to monitoring and inspection actions
p.(None): and vigilance, in the terms of this Law.
p.(None): ARTICLE 59.- The permission of commercial release to the environment of a GMO implies the authorization of commercialization of the
p.(None): body in question and the products that contain it, in the terms of this Law.
p.(None): CHAPTER III
p.(None): Study and Risk Assessment
p.(None): ARTICLE 60.- The risk assessment is the process by which they are analyzed on a case-by-case basis, based on studies
p.(None): scientifically and technically based that the interested parties should elaborate, the possible risks or effects
p.(None): that experimental release into the environment of GMOs can cause the environment and biological diversity, as well
p.(None): as to animal, vegetable and aquaculture health.
p.(None): The possible risks to human health will be subject to risk study to obtain the authorization of the GMO
p.(None): in question, in the terms of this Law.
...
p.(None): following guidelines:
p.(None): I. They must be carried out on a case-by-case basis in a transparent manner and based on scientific principles and the approach of
p.(None): caution, in the terms of this Law, taking into account expert advice;
p.(None): II. They will be carried out in the relevant fields of expertise;
p.(None): III. Lack of knowledge or scientific consensus will not necessarily be interpreted as an indicator of a given
p.(None): level of risk, absence of risk, or the existence of an acceptable risk;
p.(None): IV. They should have as a minimum basis the possible risks that would be imposed by the release of host organisms
p.(None): not genetically modified or from parental organisms, when released in that environment;
p.(None): V. The recipient organism, the genetic modification, including the genetic construction and the
p.(None): insertion method, and the environment in which the GMO is intended to be released, and
p.(None): SAW. The nature and level of detail of the information they contain may vary from case to case, depending
p.(None): of the GMO in question, its intended use and the likely receiving environment.
p.(None): ARTICLE 62.- The basic steps to be followed in the study and risk assessment are the following:
p.(None): I. The identification of new characteristics associated with the GMO that could have possible risks in
p.(None): biological diversity;
p.(None): 23 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): II. The assessment that these possible risks actually occur, taking into account the level and type of exposure
p.(None): from the GMO;
p.(None): III. The evaluation of the consequences if possible risks actually occur;
p.(None): IV. The estimation of the possible global risk represented by the GMO, based on the evaluation of the
p.(None): probability that the possible risks and consequences identified actually occur, and
p.(None): V. The recommendation as to whether the possible risks are acceptable or manageable, or are not, including
p.(None): the determination of strategies for managing these possible risks.
p.(None): ARTICLE 63.- When there is uncertainty about the level of the possible risk that GMOs may cause to the
p.(None): biological diversity, the corresponding Secretariats will request within the administrative procedure of
p.(None): permission for the release of GMOs into the environment, additional information on issues
p.(None): specific risk study or will adopt appropriate strategies for risk management and / or monitoring of
p.(None): GMO in the receiving environment.
p.(None): In case of danger of serious or irreversible damage, uncertainty about the level of possible
p.(None): risks that GMOs can cause to biological diversity or human health, should not be used as a reason
p.(None): so that the corresponding Secretariat postpones the adoption of effective measures that prevent the affectation
p.(None): negative biological diversity or human health. In the adoption of such measures, the Secretariat
...
p.(None): productive or otherwise, the socioeconomic considerations that exist regarding the release of GMOs
p.(None): to the environment, as an assessment of the risks of alternative technology options to contend with the
p.(None): specific problem for which the GMO was designed. These analyzes should be supported by
p.(None): scientific and technical evidence, in the background on use, production and consumption, and may be
p.(None): considered by the competent Secretariats as additional elements to decide on the release
p.(None): experimental to the environment, and consequent releases to the environment in pilot and commercial program, respectively,
p.(None): of the GMO in question.
p.(None): ARTICLE 65.- The characteristics and requirements of the studies to evaluate the possible risks shall be established.
p.(None): in the official Mexican norms that derive from this Law.
p.(None): CHAPTER IV
p.(None): Of the opinions
p.(None): ARTICLE 66.- The opinions that the SEMARNAT must issue will only be required in the case of
p.(None): experimental release activities, pilot program release and commercial release of GMOs
p.(None): that are the responsibility of SAGARPA. These opinions must be issued within a period of sixty days from
p.(None): after SEMARNAT receives the administrative file sent by SAGARPA. This term includes
p.(None): both the issuance of the corresponding opinion, and its referral to SAGARPA. SAGARPA will issue the permit of
p.(None): release of GMOs to the appropriate environment, provided that the opinion issued by SEMARNAT is favorable.
p.(None): 24 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): CHAPTER V
p.(None): On the Reconsideration of Negative Resolutions
p.(None): ARTICLE 67.- Those interested in whom the corresponding Secretariat has denied the requested permission may
p.(None): request said Secretariat to reconsider the respective resolution, when it is considered that:
p.(None): I. There has been a change in circumstances that may influence the outcome of the study of possible
p.(None): risks on which the resolution was based, or
p.(None): II. New relevant scientific or technical information is available from which it follows that
p.(None): Possible risks identified are not those originally intended.
p.(None): The competent Secretariat may issue a resolution within two months. In case of not doing so, it
p.(None): will consider the reconsideration dismissed.
p.(None): ARTICLE 68.- The reconsideration referred to in the preceding article does not constitute any remedy or means of defense,
p.(None): and may be promoted by interested parties regardless of whether they enforce the means of challenge established in
p.(None): This Law against the resolution that affects them.
p.(None): CHAPTER VI
p.(None): From the Permit Review
p.(None): ARTICLE 69.- The corresponding Secretariat, at any time and on the basis of new information
p.(None): scientific or technical about the possible risks that GMOs can cause to public health or the environment
p.(None): and to biological diversity, they may review the permits granted and, where appropriate, suspend their effects or revoke
p.(None): said permits, in accordance with the procedures established by the regulations that derive from this
p.(None): Law, when considering as causes that:
p.(None): I. There is a change in the circumstances of the activities that may influence the outcome of the study of the
p.(None): assessment of possible risks on which the permit was based, or
p.(None): II. Have additional scientific or technical information that could modify any
p.(None): conditions, limitations or permit requirements.
p.(None): CHAPTER VII
p.(None): Confidentiality
p.(None): ARTICLE 70.- Those interested may clearly identify in their permit application, that information
p.(None): that should be considered confidential according to the industrial property or copyright regime. The
p.(None): Corresponding secretariat shall be subject to the provisions of the laws of the matter and shall refrain from ordering to register and
p.(None): to provide third parties with information and data that are protected by these laws.
p.(None): ARTICLE 71.- They shall not be confidential:
p.(None): I. The general description of GMOs;
p.(None): II. The identification of the interested party or person responsible for the activity;
p.(None): III. The purpose and place or places of the activity;
p.(None): 25 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Biosafety, monitoring, control and emergency systems and measures, and
p.(None): V. Studies on possible risks to human health or the environment and biological diversity.
p.(None): Access to the information referred to in the previous sections shall be governed, in addition, by the provisions
p.(None): applicable in matters of access to government public information.
p.(None): CHAPTER VIII
p.(None): Export of GMOs destined for release to the environment in other countries
p.(None): ARTICLE 72.- Those interested in exporting GMOs that are destined for their release to the environment in other countries, will notify
p.(None): by itself, as determined in the regulations that derive from this Law, its intention to
p.(None): export said organisms to the competent authorities of the respective country Such notification only
p.(None): it will be carried out in cases where international treaties and agreements in which the
p.(None): United Mexican States are a party, establish that requirement to export to the country of
p.(None): try. The information that the interested party attaches to the notification referred to in this article must be exact,
p.(None): Reliable and in accordance with what is established in these international treaties and agreements.
p.(None): THIRD TITLE
p.(None): Confined Use and Notices
p.(None): CHAPTER I
p.(None): Confined use
p.(None): ARTICLE 73.- The confined use of GMOs may be for educational purposes, of
p.(None): scientific and technological, industrial or commercial research.
p.(None): ARTICLE 74.- Those who carry out confined use activities subject to the requirement of
p.(None): presentation of notice in the terms of this Law, must comply with the following:
p.(None): I. Keep a log book of the activities of confined use they carry out, which must be provided
p.(None): to the corresponding Secretariats when they request it;
p.(None): II. Apply confinement measures whose execution should be adapted to scientific knowledge and
p.(None): more modern and advanced technicians in risk management and treatment, final disposal and
p.(None): elimination of GMO residues generated during the activity, and
p.(None): III. In the case of the use confined for teaching or scientific research purposes and
p.(None): technology, integrate an internal biosafety commission and apply the principles of good practice of
p.(None): scientific research, as well as the biosafety rules defined by the internal commission of
p.(None): Biosafety This internal commission will be responsible for the security of the facilities and the
p.(None): good practices and safety in the management of GMOs used in the indicated activity.
p.(None): The official Mexican norms that derive from this Law will establish:
p.(None): A) The requirements and general characteristics that must be contained in the log book referred to in this
p.(None): article, for each type of activity;
p.(None): B) The requirements and characteristics related to confinement, treatment, final disposal, destruction and
p.(None): GMO waste disposal;
p.(None): 26 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): C) The driving conditions that are required in the various forms of confined use of said organisms, and
p.(None): D) Actions to be taken in case of accidental release of GMOs.
p.(None): ARTICLE 75.- The storage or deposit of GMOs or products containing them, which is carried out at customs
p.(None): of the national territory, will be subject to what the respective official Mexican standards that
p.(None): jointly issue the competent Secretariats, with the participation of the SHCP.
p.(None): ARTICLE 76.- The transport of GMOs or products containing them, as well as the transit of said organisms and
p.(None): Products throughout the national territory, when they have another country as their destination, will be governed by the rules
p.(None): Mexican officials who jointly issue the competent Secretariats, with the participation
p.(None): of the Ministry of Communications and Transportation.
p.(None): CHAPTER II
p.(None): Of the Notices
p.(None): ARTICLE 77.- The notice is the communication that the subjects indicated in
p.(None): this Law, to SEMARNAT or SAGARPA, as appropriate according to this order, with respect to the
p.(None): Confined use of GMOs in the cases established in this chapter.
p.(None): ARTICLE 78.- Notices must be submitted to SEMARNAT or SAGARPA, in accordance with the attributions of this Law.
p.(None): confers them, in the official formats that are issued for this purpose. The content of the formats
p.(None): They will determine said Secretariats, with the prior approval of the Federal Regulatory Improvement Commission. In sayings
p.(None): formats will determine the information and documentation that the interested party must submit. The formats must be
p.(None): publish in the Official Gazette of the Federation.
p.(None): ARTICLE 79.- Require notice submission:
p.(None): I. GMOs that are managed, generated and produced for scientific and technological teaching and research purposes;
p.(None): II. The integration of internal biosafety commissions, including the name of the
p.(None): responsible for said commissions;
p.(None): III. The first use of laboratories or specific teaching or research facilities
p.(None): scientific and technological in which GMOs are managed, generated and produced;
p.(None): IV. The production of GMOs used in industrial processes, and
p.(None): V. The first use of specific facilities where the GMOs referred to occur
p.(None): the previous fraction.
p.(None): ARTICLE 80.- The import of GMOs for use is also required for presentation of notice.
p.(None): confined for industrial or commercial purposes, only when the following assumptions are met:
p.(None): I. That they are GMOs that do not require permission, by virtue of which they are destined exclusively for their use
p.(None): confined and therefore not imported for release to the environment, and
p.(None): 27 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): II. That they are GMOs that do not require sanitary authorization because they will not be used for human use or consumption or
p.(None): for public health purposes.
p.(None): ARTICLE 81.- The subjects that must present the corresponding notice to the corresponding Secretariat are the following:
p.(None): I. In the cases referred to in sections I, II and III of article 79, the head of the internal commission of
p.(None): biosafety of the institution, center or company where the teaching activities are carried out and
p.(None): scientific and technological research in which the GMO in question is generated and produced;
p.(None): II. In the cases referred to in sections IV and V of article 79, the legal representative of the company in the
p.(None): that the GMOs in question occur, and
p.(None): III. In the case referred to in the previous article, the importer of the GMO.
p.(None): ARTICLE 82.- It is excepted from the presentation of notice, the use confined or imported for that activity, in
p.(None): if the GMO in question exempts from said requirement in the lists issued by the
p.(None): Secretariats under this Law.
p.(None): ARTICLE 83.- The confined use of GMOs and the importation of said organisms for that activity, may
p.(None): be made from the moment the internal biosafety commission or the importer, according to
p.(None): try, present the respective notice to the corresponding Secretariat.
p.(None): ARTICLE 84.- Once the notice has been submitted, the corresponding Secretariat may determine, where appropriate, with support
p.(None): scientific and technical:
p.(None): I. That in consideration of the genetically modified organism and the possible risks in its management, the
p.(None): exercise;
p.(None): II. If applicable, it may resolve that the confined use requires the adoption and implementation of requirements and
p.(None): Biosafety measures additional to those indicated by the interested party in the notice, which will be determined
p.(None): by said Secretariat, and must be observed and complied with by the interested party to continue the completion of the
p.(None): activity, or
p.(None): III. The prohibition of the confined use of the genetically modified organism in question or its importation
p.(None): For that activity.
p.(None): Said resolution may be challenged through the appeal for review established herein.
p.(None): ordering
p.(None): ARTICLE 85.- Persons whose activity of confined use is subject to the requirement of
p.(None): Notice submission will be required to observe and comply with the other provisions of this
p.(None): ordinance and the official Mexican norms that derive from it, as applicable.
p.(None): FOURTH TITLE
p.(None): Restricted Areas
p.(None): CHAPTER I
p.(None): Centers of Origin and Genetic Diversity
p.(None): 28 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 86.- The species of which the United Mexican States is a center of origin and genetic diversity as well
p.(None): as the geographical areas in which they are located, will be determined jointly through agreements by the
p.(None): SEMARNAT and SAGARPA, based on the information they have in their files or in their databases,
p.(None): including the one that provides, among others, the National Institute of Statistics, Geography and Informatics,
p.(None): the National Institute of Forestry, Agricultural and Livestock Research, the National Institute of
p.(None): Ecology, the National Commission for the Knowledge and Use of Biodiversity and the National Commission
p.(None): Forestry, as well as international agreements and treaties related to these matters. SEMARNAT and SAGARPA
p.(None): they will establish in the agreements that issue, the necessary measures for the protection of said
p.(None): species and geographic areas.
p.(None): ARTICLE 87.- For the determination of the centers of origin and genetic diversity, the
p.(None): following criteria:
p.(None): I. That they are considered centers of genetic diversity, understanding by them the regions that currently
p.(None): they host populations of the wild relatives of the GMO in question, including different races or
p.(None): varieties thereof, which constitute a genetic reserve of the material, and
p.(None): II. In the case of crops, the geographical regions where the organism in question was
p.(None): domesticated, as long as these regions are centers of genetic diversity.
p.(None): ARTICLE 88.- In the centers of origin and genetic diversity of animal and plant species only allowed
p.(None): the release of GMOs in the case of GMOs other than native species, always
p.(None): that their release does not cause a negative impact on human health or biological diversity.
p.(None): CHAPTER II
p.(None): Of the Activities with GMOs in Protected Natural Areas
p.(None): ARTICLE 89.- In the protected natural areas created in accordance with the provisions of the matter,
p.(None): only activities with GMOs will be allowed for bioremediation purposes, in cases where pests appear or
p.(None): pollutants that could endanger the existence of animal, vegetable or aquaculture species, and
p.(None): GMOs have been created to avoid or combat this situation, provided that the scientific elements and
p.(None): necessary technicians who support the environmental benefit that is intended to be obtained, and such activities are allowed
p.(None): by SEMARNAT in the terms of this Law.
p.(None): For the purposes of the provisions of the preceding paragraph, it is prohibited to carry out activities with GMOs in the areas
p.(None): core of protected natural areas.
p.(None): In the event that any center of origin or center of genetic diversity is located within a natural area
p.(None): protected, the declarations of creation and the management programs of these areas will be modified in the
p.(None): terms of the legislation of the matter, as the determinations referred to in Article 86 of
p.(None): This Law
p.(None): CHAPTER III
p.(None): GMO Free Zones
p.(None): ARTICLE 90.- GMO-free zones may be established for the protection of agricultural products
p.(None): organic and others of interest to the requesting community, in accordance with the following general guidelines:
p.(None): 29 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): I. Free zones will be established in the case of GMOs of the same species to which they are
p.(None): Produce through production processes of organic agricultural products, and be proven scientifically and technically
p.(None): that their coexistence is not viable or that they would not comply with the regulatory requirements for their certification;
p.(None): II. These areas will be determined by SAGARPA through agreements that will be published in the Journal.
p.(None): Official of the Federation, previous opinion of the CIBIOGEM, with the opinion of the National Commission for
p.(None): Knowledge and Use of Biodiversity, taking into account what is established in official regulations
p.(None): Mexican relative to organic agricultural products;
p.(None): III. The determination of free zones will be made based on the following requirements:
p.(None): A. It will be made at the written request of the communities concerned, through their legal representative;
p.(None): B. This request must be accompanied by the favorable opinion of the governments of the entities
p.(None): federation and municipal governments of places or regions to be determined as free zones;
p.(None): C. Evaluations of the effects that GMOs may cause to the production processes of
p.(None): organic agricultural products or biodiversity, through which it is demonstrated,
p.(None): scientifically and technically, that its coexistence is not viable or does not meet the regulatory requirements for its
p.(None): certification, in accordance with the official Mexican standards issued by SAGARPA. The evaluations
p.(None): mentioned shall be carried out as established by said Secretariat in official Mexican standards, and
p.(None): IV. SAGARPA will establish in the agreements the security measures that may be adopted in GMO-free zones,
p.(None): in order to ensure adequate protection of organic agricultural products.
p.(None): FIFTH TITLE
p.(None): On the Protection of Human Health in relation to GMOs
p.(None): CHAPTER I
p.(None): Of GMO Authorizations
p.(None): ARTICLE 91.- The GMOs subject to authorization are the following:
p.(None): I. Those that are intended for human use or consumption, including grains;
p.(None): II. Those that are used for food processing for human consumption;
p.(None): III. Those with public health purposes, and
p.(None): IV. Those that are destined to bioremediation.
p.(None): For the purposes of this Law, GMOs for human use or consumption are also considered to be those for consumption
p.(None): animal and that can be consumed directly by the human being.
p.(None): ARTICLE 92.- The request for authorization of a GMO must be accompanied by the following requirements:
p.(None): I. The study of the possible risks that the human use or consumption of the GMO in question could represent the
p.(None): human health, which will include scientific and technical information related to its safety, and
p.(None): 30 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): II. The other requirements that are determined in the official Mexican norms that derive from this Law.
p.(None): The guidelines, criteria, characteristics and requirements of the studies of the possible risks that GMOs may
p.(None): cause to human health, will be determined by the SSA in the official Mexican standards issued
p.(None): in accordance with this Law.
p.(None): ARTICLE 93.- In the case of authorization requests from a GMO to be able to import
p.(None): for the purposes referred to in article 91 of this Law, in addition to what is established in the previous article,
p.(None): the interested party must attach the information and documentation proving that the GMO is authorized
p.(None): according to the legislation of the country of origin. Failing that, the interested party will manifest the absence of said
p.(None): situation, and will expose the elements of consideration that support the SSA can resolve the request for
p.(None): authorization.
p.(None): ARTICLE 94.- Once the SSA receives an authorization request, and as long as it complies with the information
p.(None): and the requirements established in this Law, you must send it to the Registry, for its registration and publicity
p.(None): respective.
p.(None): ARTICLE 95.- Authorizations must be issued within a period not exceeding six months from
p.(None): after the SSA receives the authorization request from the interested party and the information
p.(None): provided in said application is complete.
p.(None): ARTICLE 96.- The SSA will issue its resolution, once it has analyzed the information and documentation
p.(None): contributed by the interested party. Said Secretariat in its resolution may, founded and motivated:
p.(None): I. Issue the authorization, or
p.(None): II. Deny authorization in the following cases:
p.(None): A) When the request does not comply with the provisions of this Law or the official Mexican regulations such as
p.(None): requirements for the granting of authorization;
p.(None): B) When the information provided by the interested party is false, incomplete or insufficient, or
p.(None): C) When the SSA concludes that the risks that such organisms may present will negatively affect
p.(None): human health, which can cause serious or irreversible damage.
p.(None): The SSA will base its resolutions in accordance with the scientifically and technically supported identification of the possible
p.(None): risks that GMOs could generate, and the real possibility of affecting human health by these organisms.
p.(None): ARTICLE 97.- GMOs authorized by the SSA may be freely marketed and imported for
p.(None): commercialization, as well as products containing said organisms and products derived therefrom.
p.(None): The foregoing without prejudice to said authorized bodies, the products containing them and the products
p.(None): derivatives are subject to the general health control regime established by the General Health Law and its
p.(None): regulations and, if applicable, the corresponding phytozoosanitary requirements.
p.(None): 31 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 98.- The relative provisions shall apply to the administrative authorization procedure.
p.(None): of the Second Title, regarding the Reconsideration of Negative Resolutions, Review of Permits and
p.(None): Confidentiality
p.(None): CHAPTER II
p.(None): Additional Provisions
p.(None): ARTICLE 99.- The packaging of GMOs and products containing them, for human use or consumption, is
p.(None): will be governed by the official Mexican regulations issued by the SSA, together with the Secretariat of
p.(None): Economy, in accordance with the General Health Law and its regulatory provisions, and with the
p.(None): Federal Law on Metrology and Standardization.
p.(None): ARTICLE 100.- The development, production, commercialization and in general process of GMOs with effects
p.(None): Therapeutics, in addition to what is established in this Law, will be subject to the provisions of the General Health Law and
p.(None): other regulations applicable to medicines and drugs.
p.(None): SIXTH TITLE
p.(None): Labeling and Identification of GMOs
p.(None): ARTICLE 101.- GMOs or products containing genetically modified organisms, authorized by the
p.(None): SSA for its safety in the terms of this Law and that are for direct human consumption, must guarantee the
p.(None): explicit reference of genetically modified organisms and indicate on the label the information of their
p.(None): nutritional composition or its nutritional properties, in those cases in which these characteristics
p.(None): are significantly different from conventional products, and also comply with the
p.(None): Additional general labeling requirements in accordance with official Mexican standards issued by the SSA, in accordance
...
p.(None): of Economy. Regarding this type of GMOs, it will be mandatory to record on the label that these are organisms
p.(None): genetically modified, the characteristics of the acquired genetic combination and its relative implications
p.(None): to special conditions and crop requirements, as well as changes in reproductive characteristics and
p.(None): productive.
p.(None): The conformity assessment of said official Mexican standards will be carried out by the SSA, SAGARPA and
p.(None): the Ministry of Economy within the scope of their respective competencies and the persons accredited and approved according
p.(None): to the provisions of the Federal Law on Metrology and Standardization.
p.(None): ARTICLE 102.- The information requirements that must be included in the documentation that accompanies the GMOs that are
p.(None): Import according to this Law, they will be established in official Mexican norms that derive from this ordinance,
p.(None): considering in its expedition the purpose to which said organisms are destined and what is
p.(None): establish in international treaties to which the United Mexican States are a party. The rules
p.(None): Mexican officials referred to in this article will be issued jointly by SAGARPA, SSA and the
p.(None): Ministry of Economy In the event that the import of GMOs is carried out for the purpose of their release into the environment,
p.(None): The official Mexican standards referred to in this article will be issued by the designated Secretariats
p.(None): jointly with SEMARNAT.
p.(None): SEVENTH TITLE
p.(None): 32 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): From the Lists of GMOs
p.(None): ARTICLE 103.- The lists of GMOs that are issued and published under this Law shall be the following:
p.(None): I. Those of GMOs that have permission for their commercial release or for their importation for that activity;
p.(None): II. Those of GMOs that do not have permission for their commercial release or for their importation for that activity;
p.(None): III. Those of GMOs authorized by the SSA, and
p.(None): IV. Those of GMOs to carry out activities of confined use of GMOs for teaching and research purposes
p.(None): Scientific and technological
p.(None): The lists of GMOs referred to in this article will be issued and published by the competent Secretariats with the
p.(None): periodicity established by the regulations that derive from this Law and in accordance with
p.(None): established in this Title. They will have the purpose of making the interested parties and the public known
p.(None): in general, the result of the resolutions issued regarding permit applications and
p.(None): authorizations
p.(None): ARTICLE 104.- The list of GMOs referred to in sections I and II of the previous article shall be
p.(None): prepared considering the results of the case-by-case evaluation and issued jointly by SEMARNAT, the SSA and
p.(None): SAGARPA, and will be published for its knowledge and dissemination in the Official Gazette of the Federation.
p.(None): The purposes of the list referred to in this article will be:
p.(None): I. Indicate the legal status of those GMOs, and
p.(None): II. Determine the cases in which the GMOs allowed for commercial release or for importation
p.(None): for that activity they can be released and imported freely in the geographic areas that are determined according to
p.(None): Case by case analysis.
p.(None): In this list, the corresponding Secretariats may indicate the cases in which the import, use, handling and
p.(None): The release of these organisms can be carried out without conditions, as well as the cases in which they must be met
p.(None): Specific conditions.
p.(None): ARTICLE 105.- The list of GMOs that have authorization will be prepared and issued by the SSA, considering the
p.(None): Results of the case-by-case evaluation of the possible risks of these health agencies
p.(None): human, and will be published for knowledge and dissemination in the Official Gazette of the Federation. Its purposes will be
p.(None): indicate the legal situation in which these GMOs are, and determine the cases in which the
p.(None): GMOs authorized under this Law may be marketed and imported.
p.(None): ARTICLE 106.- The list of GMOs to carry out activities of confined use of said organisms
p.(None): for teaching and scientific and technological research purposes it will be issued jointly
p.(None): by the Secretariats, and will be published for their knowledge and dissemination in the Official Gazette of the Federation.
p.(None): 33 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 107.- In the formulation, issuance and modification of the GMO information lists, the following shall be observed.
p.(None): that is established in the regulatory provisions that derive from this ordinance,
p.(None): taking into account the following guidelines:
p.(None): They will be formulated according to:
p.(None): I. The nature of the genetically modified organism;
p.(None): II. The presence in the country or region of interest, of sexually compatible species with the organism genetically
p.(None): modified;
p.(None): III. The type of sexual reproduction of the genetically modified organism and native species
p.(None): sexually compatible;
p.(None): IV. The nature of the receiving or parental organism;
p.(None): V. The characteristics of the vector and the insert of genetic material used in the operation;
p.(None): SAW. The capacity and form of propagation of genetically modified organisms;
p.(None): VII. The existence of wild relatives in any area or region of the national territory that is its center
p.(None): originally;
p.(None): VIII. The scale or volume of handling, and
p.(None): IX. The possible effects or risks that the different activities with these organisms could cause to the
p.(None): environment and biological diversity or human health or animal, plant or aquaculture health.
p.(None): EIGHTH TITLE
p.(None): About Biosafety Information
p.(None): CHAPTER I
p.(None): From the National Biosafety Information System
p.(None): ARTICLE 108.- The CIBIOGEM, through its Executive Secretariat, will develop the National Information System on
p.(None): Biosafety that will aim to organize, update and disseminate information on biosafety. In said
p.(None): System, CIBIOGEM must integrate, among other aspects, the information corresponding to the Registry.
p.(None): The CIBIOGEM will gather relevant reports and documents resulting from scientific, academic, work activities
p.(None): technicians or any other type of biosafety, including the safety of GMOs, carried out
p.(None): by natural or legal persons, national or foreign, who will be referred and organized by the National System
p.(None): Information on Biosafety. In addition, it will prepare and publish annually a detailed report of the situation
p.(None): general existing in the country regarding biotechnology and biosafety subject of this Law.
p.(None): The CIBIOGEM will also carry out the studies and socio-economic considerations resulting from the effects of the
p.(None): GMOs that are released to the environment in the national territory, and will establish the mechanisms to carry out the
p.(None): consultation and participation of indigenous peoples and communities settled in areas where liberation is sought
p.(None): of GMOs, considering the value of biological diversity.
p.(None): 34 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): Likewise, the CIBIOGEM Executive Secretariat will serve as the National Focal Center before the Secretariat
p.(None): of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity,
p.(None): being responsible for liaising with said Secretariat and for complying with the provisions of Article 19 of
p.(None): said International Treaty. The CIBIOGEM Executive Secretariat will also be responsible for providing
p.(None): Biosafety Information Exchange Center established in the aforementioned Protocol,
p.(None): any information about:
p.(None): I. Existing national laws, regulations and guidelines for the application of the Protocol, as well as information and
p.(None): documentation required, in terms of this Law, for the administrative permit procedure
p.(None): of import of GMOs to be released experimentally, in pilot program or commercially;
p.(None): II. Bilateral, regional and multilateral agreements and arrangements;
p.(None): III. Summaries of GMO risk assessments, as well as relevant product information
p.(None): GMO derivatives;
p.(None): IV. Final resolutions on the importation or release into the environment of GMOs, as well as the modification
p.(None): of resolutions derived from its revision in accordance with this Law;
p.(None): V. The socioeconomic effects of GMOs, especially in indigenous and local communities, and
p.(None): SAW. Reports on compliance with the obligations established in the Protocol, including those relating to the
p.(None): application of the procedure for importing GMOs to be released into the environment experimentally, in program
p.(None): pilot or commercial
p.(None): The competent Secretariats may provide directly to the Information Exchange Center
p.(None): on Biosafety, the information referred to in the previous sections, informing
p.(None): simultaneously to the Executive Secretariat of the CIBIOGEM.
p.(None): CHAPTER II
p.(None): From the National Biosafety Registry of GMOs
p.(None): ARTICLE 109.- The Registry, which will be in charge of the CIBIOGEM Executive Secretariat, will be public and
p.(None): Its purpose is to register information related to activities with GMOs, as well as their own
p.(None): organisms. Its operation and what may be subject to registration will be determined in the provisions
p.(None): regulations that derive from this Law. SEMARNAT, SAGARPA and SSA will contribute to the organization and
p.(None): Registry operation.
p.(None): NINTH TITLE
p.(None): Of the Official Mexican Standards in Biosafety
p.(None): ARTICLE 110.- To guarantee the biosecurity of activities with GMOs, the Secretariats, jointly or
p.(None): with the participation of other agencies of the Federal Public Administration, they will issue regulations
p.(None): Mexican officials whose purpose is to establish guidelines, criteria, technical specifications
p.(None): and procedures in accordance with the provisions of this Law.
p.(None): ARTICLE 111.- In the formulation of official Mexican standards regarding biosafety, it should be considered that the
p.(None): compliance with its forecasts must be carried out in accordance with the characteristics of each activity or
p.(None): production process with GMOs.
p.(None): 35 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 112.- The application of the official Mexican norms regarding biosafety, as well as the
p.(None): Inspection and surveillance acts will correspond exclusively to the competent Secretariats under the terms of this
p.(None): Law. Compliance with these standards may be evaluated by certification bodies, units of
p.(None): verification and testing laboratories approved by said Secretariats in accordance with the provisions
p.(None): regulations that derive from this ordinance and with the Federal Law on Metrology and Standardization.
p.(None): TENTH TITLE
p.(None): Inspection and Surveillance and Security or Urgent Measures Application
p.(None): CHAPTER I
p.(None): Inspection and Surveillance
p.(None): ARTICLE 113.- To verify and verify compliance with this Law, its regulations and standards
p.(None): Mexican officers derived from it, the competent Secretariats may carry out through
p.(None): duly authorized personnel, the inspection and surveillance acts they deem necessary, by
p.(None): through the Administrative Units legally authorized to do so, in accordance with this Law.
p.(None): ARTICLE 114.- Regarding the requirements and formalities that must be observed in the realization
p.(None): of inspection and surveillance visits, the provisions are supplementary to this Chapter
p.(None): of the Eleventh Chapter of the Third Title of the Federal Law of Administrative Procedure. In matter
p.(None): of restoration or compensation of damage to the environment or biological diversity, the provisions may apply
p.(None): in the second paragraph of Article 168 of the General Law of Ecological Balance and Environmental Protection.
p.(None): CHAPTER II
p.(None): Security or Urgent Measures Application
p.(None): ARTICLE 115.- The Secretariats, within the scope of their competence under this Law, will order some or some of the
p.(None): measures that are established in this article, in the event that in carrying out activities with GMOs the
p.(None): next:
p.(None): I. Risks not originally foreseen arise, which could cause damage or adverse effects and
p.(None): significant to human health or biological diversity or animal, plant or aquaculture health;
p.(None): II. Damage or adverse and significant effects are caused to human health or biological diversity or health
p.(None): animal, vegetable or aquaculture, or
p.(None): III. GMOs not allowed and / or unauthorized into the environment are accidentally released.
p.(None): In these cases, the measures may be the following:
p.(None): A. Temporary, partial or total closure of the places and / or facilities in which they are handled or
p.(None): store GMOs or develop activities that give rise to the assumptions that give rise to taxation
p.(None): of the measure;
p.(None): B. The precautionary assurance of GMOs, in addition to goods, vehicles, utensils and instruments directly
p.(None): related to the action or omission that gives rise to the measure;
p.(None): C. The temporary, total or partial suspension of the activity that motivates the imposition of the measure;
p.(None): 36 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): D. The repatriation of GMOs to their country of origin;
p.(None): E. The performance of the necessary actions and measures to avoid continuing to present the assumptions that
p.(None): motivate the imposition of the measure, and
p.(None): F. The destruction of GMOs in question, at the expense of the interested party, for which the following should be addressed:
p.(None): a) Proceed only if the risks or damages are serious or irreparable, and only by
p.(None): the imposition of this measure is possible to avoid, mitigate or mitigate the risks or damages that motivated it;
p.(None): b) To determine the imposition of the measure, the competent Secretariat must issue an opinion, based on technical and
p.(None): scientifically, by means of which the origin of the destruction of the GMO in question is justified,
p.(None): having to make it known to the interested party, so that the latter within five days exposes
p.(None): what is convenient for you and, where appropriate, provide the evidence you have, and
p.(None): c) As long as the competent Secretariat dictates the corresponding resolution, it may order, in advance,
p.(None): the precautionary assurance of GMOs, which can be carried out by the Secretariat itself or through the
p.(None): interested.
p.(None): Likewise, the competent Secretariat that imposes the measures referred to in this article may promote
p.(None): before the other competent Secretariats, the execution of some or some measures established in
p.(None): Other systems.
p.(None): ARTICLE 116.- When the competent Secretariats order any of the measures provided for in the previous article,
...
p.(None): If the interested party will refuse to carry out the actions to correct the irregularities that
p.(None): motivated the imposition of the measure (s) in question, the Secretariat that has imposed them
p.(None): will perform immediately, with full charge to the reluctant interested party.
p.(None): In the event that the interested party carries out security measures or urgently applied or remedies irregularities
p.(None): incurred, prior to the competent Secretariat imposing some or some of the sanctions
p.(None): established in this Law, said Secretariat shall consider such situation as mitigating the infraction.
p.(None): committed.
p.(None): ARTICLE 117.- In case of accidental releases of GMOs that are verified in the national territory,
p.(None): and that they could have significant adverse effects on the biological diversity or human health of
p.(None): another country, the competent Secretariat shall notify such situation to the corresponding authority of the country that could
p.(None): be affected by such release. Such notification must include:
p.(None): I. Information on the estimated quantities and the characteristics and / or important features of the GMO;
p.(None): II. Information on the circumstances and the estimated date of the accidental release, as well as the use of the
p.(None): GMO in the national territory;
p.(None): III. Information available on possible adverse effects for biological diversity and human health;
p.(None): 37 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Information available on possible regulatory measures, attention and risk control, and
p.(None): V. A point of contact for additional information.
p.(None): Notwithstanding the foregoing, the Secretariats, within the scope of their powers under this Law, will carry out the
p.(None): actions and measures necessary to minimize any risk or adverse effect that the GMOs released
p.(None): They could accidentally cause. Such actions and measures will be ordered by the Secretariats to whom there are
p.(None): caused the accidental release of GMOs to the environment, who must comply immediately. In case
p.(None): Otherwise, the Secretariats will proceed in accordance with the provisions of the second paragraph of the previous article.
p.(None): ARTICLE 118.- The provisions of the Single Chapter of Title Five are supplementary to this Chapter.
p.(None): of the Federal Law of Administrative Procedure, except for the provisions of the previous article.
p.(None): Twelve eleventh
p.(None): Infractions, Sanctions and Responsibilities
p.(None): CHAPTER I
p.(None): Of the Infractions
p.(None): ARTICLE 119.- The person who, in full, incurs administrative violations of the provisions of this Law.
p.(None): knowledge that it is about GMOs:
p.(None): I. Perform activities with GMOs without the respective permits and authorizations;
p.(None): II. Perform activities with GMOs in breach of the terms and conditions established in the permits and
p.(None): respective authorizations;
p.(None): III. Perform activities of confined use of GMOs, without presenting the notices in the terms
p.(None): established in this Law;
p.(None): IV. Carry out activities with GMOs that are subject or exempt from the notice submission, in breach of the
p.(None): other provisions of this Law, its regulations and the official Mexican norms that derive therefrom,
p.(None): that are applicable to the activity in question or that are common to all activities in
p.(None): biosecurity matter;
p.(None): V. Present to the competent Secretariats, information and / or documentation referred to in this
p.(None): system that is false, including the one related to the possible risks that activities with GMOs could
p.(None): cause human health or biological diversity;
p.(None): SAW. Breaches the sanitary, monitoring, control and prevention measures indicated by those interested in the information
p.(None): and documentation provided to obtain the respective permits and authorizations, and those established by the
p.(None): Secretariats in their own permits and authorizations;
p.(None): VII. Breaches the control and response measures in case of emergency indicated by the interested parties
p.(None): in their studies of the possible risks that activities with GMOs may cause to human health or
p.(None): biological diversity or animal, plant or aquaculture health;
p.(None): VIII. Breaches the obligation to inform or inform the Secretariats, in the cases established in
p.(None): this law;
p.(None): 38 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IX. Breaches the obligation to adopt and implement additional biosecurity requirements and measures
p.(None): determined by the Secretariats, in cases of confined use activities subject to notice, in
p.(None): so be determined;
p.(None): X. Failure to review, implement or adopt new sanitary, monitoring, control and
p.(None): prevention, in the cases in which the competent Secretariats so determine in accordance with the provisions of this Law;
p.(None): XI Carry out activities with GMOs or with any other body whose purpose is the manufacture and / or use of
p.(None): biological weapons;
p.(None): XII. Make releases of GMOs in centers of origin and genetic diversity, outside the cases
p.(None): established in this Law;
p.(None): XIII Carry out activities with GMOs in the protected natural areas indicated in this Law, outside the cases
p.(None): established by it;
p.(None): XIV Failure to inform the SEMARNAT or SAGARPA, according to their field of competence
p.(None): pursuant to this Law, through the corresponding report, the results of the release
p.(None): experimental or pilot program releases, which have the respective permit;
p.(None): XV. Import GMOs that are prohibited in the country of origin or are classified as not allowed for
p.(None): its commercial release or for its importation for that activity in the lists referred to in this Law, when
p.(None): Corresponding secretariats would not have positively determined that these prohibitions are not applicable in the
p.(None): National territory;
p.(None): XVI. Present the notices to the corresponding Secretariats without being signed by the person who must do it
p.(None): compliance with this Law;
p.(None): XVII Do not carry and / or do not provide the corresponding Secretariat with the logbook of the activities that are
p.(None): perform in confined use, in the terms established in this Law and in the official norms
p.(None): Mexicans that derive from it;
p.(None): XVIII. Do not suspend the activity of use confined in cases where the Secretariats
p.(None): corresponding, once the notice has been submitted by the interested party, determine said situation and, in its
p.(None): case, that the activity requires additional biosecurity requirements or measures to continue its
p.(None): realization;
p.(None): XIX. Perform confined utilization activities by ceasing to apply confinement and treatment measures,
p.(None): final disposal and disposal of GMO residues generated in carrying out the activity;
p.(None): XX. Breaches the provisions regarding the generation, treatment, confinement, final disposal, destruction or
p.(None): GMO waste disposal, established in the official Mexican regulations derived from this
p.(None): ordering;
p.(None): XXI. Do not integrate the internal biosafety commissions in the cases, forms and deadlines established by the
p.(None): regulatory provisions derived from this Law;
p.(None): XXII. Breaches the obligation to carry out security or urgent actions and measures
p.(None): application established by the competent Secretariats, in the cases and terms established in this Law;
p.(None): 39 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): XXIII. Failure to comply with the provisions of this Law and the official Mexican regulations derived therefrom, related to the
p.(None): labeling of products containing GMOs and products derived from said organisms;
p.(None): XXIV Fail to comply with the provisions of this ordinance and the official Mexican regulations derived therefrom, related to
p.(None): the identification of GMOs;
p.(None): XXV Perform activities of confined use of GMOs, other than those expressed in the notices presented in
p.(None): the terms of this Law;
p.(None): XXVI Perform activities with GMOs other than those allowed, or allocate GMOs for purposes other than those allowed
p.(None): or authorized;
p.(None): XXVII. Intentionally release GMOs to the environment without having release permits and, where appropriate,
p.(None): authorizations, that correspond according to this Law, and
p.(None): XXVIII. Release GMOs into the environment that have been imported or produced in the national territory, in the terms of
p.(None): This Law, for direct human or animal consumption, for food processing for human consumption, or for other uses
p.(None): other than its release to the environment.
p.(None): CHAPTER II
p.(None): Of the Sanctions
p.(None): ARTICLE 120.- The infractions to the precepts of this Law, its regulations and the official Mexican norms that of
p.(None): they derive, indicated in the previous article, will be sanctioned administratively by the competent Secretariats,
p.(None): with one or more of the following penalties:
p.(None): I. Fine of five hundred to fifteen thousand days of general minimum wage in force in the Federal District to
p.(None): who commits the infractions provided for in sections IV, V, VIII, XIV, XVI, XVII, and XXI of article 119 of this
p.(None): Law;
p.(None): II. Fine of fifteen thousand one to thirty thousand days of general minimum wage in force in the Federal District to whom it commits
p.(None): the infractions foreseen in fractions I, II, III, VI, VII, IX, X, XI, XII, XIII, XV, XVIII, XIX, XX, XXII,
p.(None): XXIII, XXIV, XXV, XXVI and XXVII of article 119 of this system.
p.(None): In the case of recidivism, the amount of the corresponding fine will be doubled. For the purposes of this fraction, it
p.(None): considers the offender to be a repeat offender who commits more than once in conduct that involves infractions to a
p.(None): same precept, in a period of two years, counted from the date on which the competent Secretariat determines
p.(None): by means of a definitive resolution the commission of the first infraction, and provided that this had not been
p.(None): distorted;
p.(None): III. Temporary or definitive closure, partial or total, of the facilities in which the
p.(None): infractions when:
p.(None): A) The infractions generate possible risks or adverse effects to human health or biological diversity or
p.(None): animal, vegetable or aquaculture health;
p.(None): B) The offender has not complied with the deadlines and conditions imposed by the Secretariats
p.(None): competent, with the security measures or urgently ordered, or
p.(None): C) It is a matter of repeated disobedience to the fulfillment of some or some security measures or urgent application
p.(None): imposed by the competent Secretariats;
p.(None): 40 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Confiscation of instruments, copies, organisms obtained or directly related products
p.(None): with the offenses committed;
p.(None): V. The suspension or revocation of permits and corresponding authorizations;
p.(None): SAW. Administrative arrest for up to thirty-six hours, and
p.(None): VII. Prohibition of experimental release, pilot program release or
p.(None): marketing of GMOs or the products that contain them.
p.(None): ARTICLE 121.- Regardless of the provisions of the preceding Article, any person who, with full knowledge of
p.(None): that these are GMOs, cause damage to third parties in their property or to their health, due to the improper use or handling of said
p.(None): agencies, will be responsible and will be obliged to repair them under the terms of federal civil legislation.
p.(None): The same obligation will be assumed by the person who damages the environment or biological diversity, due to improper use or handling
p.(None): of GMOs, for which the provisions of Article 203 of the General Law of Ecological Balance and the
p.(None): Environmental Protection
p.(None): Those directly affected in their property may request the judge to request the Secretariat
p.(None): competent so that, through its respective scientific technical committee that establishes according to this
p.(None): order, prepare a technical opinion whose purpose is to prove the existence of the damage, and serve as the basis for the judge
...
p.(None): previous opinion of the National Commission for the Knowledge and Use of Biodiversity.
p.(None): In the cases referred to in the previous sections, the Federal Attorney General's Office
p.(None): Ambiente will proceed to exercise the action of responsibility based on the technical opinion that for such effect elaborates
p.(None): the scientific technical committee of the SEMARNAT. For the formulation of the opinion, the scientific technical committee will evaluate
p.(None): the information and the elements available to the Federal Attorney for Environmental Protection, whether
p.(None): that work in the administrative file or those provided by the complainants, respectively, and
p.(None): determine, where appropriate, the existence of the damage. They will be competent to know about the actions of
p.(None): liability for damage to the environment or biological diversity in the terms of this
p.(None): Article, the district courts in civil matters, in accordance with the territorial jurisdiction established in the
p.(None): respective provisions.
p.(None): The administrative sanctions established in the previous Article shall apply without prejudice, where appropriate,
p.(None): of the corresponding penalties when the acts or omissions constituting violations of this Law, are also
p.(None): constitutive of crime in accordance with the applicable provisions of the Federal Criminal Code.
p.(None): 41 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 122.- They are additionally applicable to this Chapter regarding administrative responsibilities,
p.(None): the provisions of the Single Chapter of the Fourth Title of the Federal Law of Administrative Procedure, with the exception
p.(None): of article 70-A of said system.
p.(None): TITLE TENTH
p.(None): Review Resource
p.(None): ARTICLE 123.- The final resolutions issued in the administrative procedures on the occasion of the
p.(None): application of this Law, its regulations and the rules that derive from it, may be challenged by the
p.(None): affected by the appeal for review, within fifteen days following the date of its notification, or before
p.(None): the competent jurisdictional instances.
p.(None): The appeal for review will be filed directly with the Secretariat that issued the contested decision,
p.(None): who in his case, will grant his admission, and the granting or the denial of the suspension of the act appealed, taking turns
p.(None): the recourse to your superior in the same Secretariat for final resolution.
p.(None): ARTICLE 124.- As regards the other procedures related to the substantiation of the appeal for review to
p.(None): referred to in the previous article, the provisions of Title Six of the Federal Law of
p.(None): Administrative Procedure.
p.(None): TRANSITORY
p.(None): FIRST ARTICLE.- This Law shall enter into force within thirty business days of its publication in the
p.(None): Official Journal of the Federation.
p.(None): SECOND ARTICLE.- The competent Secretariats shall issue and publish in the Official Gazette of the Federation the
p.(None): notice formats referred to in this order, within twenty days following the approval of the
p.(None): themselves by the Federal Regulatory Improvement Commission.
p.(None): THIRD ARTICLE.- Once the formats referred to in the transitory article have been issued and published
p.(None): above, those interested in accordance with this Law have the obligation to submit notices, must do so
p.(None): within a period of ninety days from the publication of said formats in the Official Gazette of
p.(None): the Federation
p.(None): FOURTH ARTICLE.- The holders of the authorizations granted prior to the issuance of this Law shall not be
p.(None): affected by virtue of the entry into force of this system in the rights and obligations set forth in the
p.(None): same.
p.(None): ARTICLE FIVE.- The authorization requests whose processing has been initiated previously
p.(None): to the issuance of this Law, and that are pending resolution, must be resolved in accordance with the
p.(None): legal and administrative provisions in force at the time these applications were entered.
p.(None): ARTICLE SIX.- The SHCP will perform the necessary acts to transfer the resources necessary for the operation
p.(None): of the Executive Secretariat and the Scientific Advisory Board of the CIBIOGEM, and will approve the places that are
p.(None): necessary for the operation of the Executive Secretariat of said CIBIOGEM, charged to the resources
p.(None): that has approved said Commission, as well as those that the dependencies and entities that integrate said
p.(None): Commission, have them approved for such purposes, under the terms of the applicable provisions.
p.(None): 42 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): The actions that derive from the fulfillment of this Law and other dispositions that derive from it, will be attended with
p.(None): charge to the budget availability approved for this purpose to the dependencies and entities of the Administration
p.(None): Federal Public that make up the CIBIOGEM.
p.(None): The Presidential Agreement by which the CIBIOGEM was created will continue in force in what does not oppose this Law, until
p.(None): as long as the corresponding regulatory provisions of this system are issued.
p.(None): ARTICLE SEVEN.- The regulatory provisions relating to the provisions of Chapter IV of Title One of the
p.(None): This Law, as well as those corresponding to Chapters I and II of the Eighth Title of this same system, shall
p.(None): must issue within six months from the entry into force of this
p.(None): ordering The CIBIOGEM will issue its rules of operation within sixty days after entering
p.(None): vigor of the regulatory provisions indicated in this article.
p.(None): ARTICLE EIGHT.- The call to integrate the Advisory Council will be issued within thirty days
p.(None): following the entry into force of this Law, and will be integrated within three months following the
p.(None): Publication of the call.
p.(None): NINTH ARTICLE.- CONACyT will do what is necessary to modify the trust it has established
p.(None): for the management of resources of the Intersecretarial Commission created through the Presidential Agreement
p.(None): published in the Official Gazette of the Federation on November 5, 1999, to comply with this
p.(None): Law, so that it operates in the future as the Fund for the Promotion and Support of Scientific Research and
p.(None): Technology in Biosafety and Biotechnology that establishes the present order.
p.(None): ARTICLE TEN.- The program for the development of biosafety and biotechnology referred to in article 29
p.(None): of this Law, it will be formulated and issued in a period not exceeding one year from the entry into force of this
p.(None): ordering
p.(None): ARTICLE ELEVENTH.- The preliminary draft of the official Mexican standards referred to in the articles
p.(None): 42, section VII, 50 section V, 55 section VII, 74, 101 and 102 of this Law, must be presented to the Committees
p.(None): Corresponding National Standardization Consultants and joining the National Standardization Program, within
p.(None): a term not exceeding six months from the entry into force of this ordinance, in accordance and
p.(None): for the effects established in the Federal Law on Metrology and Standardization.
p.(None): The preliminary draft of the other official Mexican standards referred to in this Law shall be submitted within the term of
p.(None): one year from the entry into force of this ordinance, for the purposes indicated in the paragraph
p.(None): previous.
p.(None): While the official Mexican standards referred to in articles 42, section VII, 50 section V and 55 are issued
p.(None): Section VII of this Law, SEMARNAT and SAGARPA, in their respective fields of competence, may determine the
p.(None): information deemed necessary, with the participation that corresponds to the Federal Improvement Commission
p.(None): Regulatory, and within a period not exceeding one year from the entry into force of the
p.(None): present order, in order to issue the corresponding permits.
p.(None): TENTH ARTICLE.- All legal provisions that oppose this Law are repealed.
p.(None): 43 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): Mexico, D.F., February 15, 2005.- Dip. Manlio Fabio Beltrones Rivera, President.- Sen. Diego Fernández de
p.(None): Cevallos Ramos, President.- Dip. Marcos Morales Torres, Secretary.- Sen. Sara I. Castellanos Cortés,
p.(None): Secretary.- Rubrics. "
p.(None): In compliance with the provisions of section I of Article 89 of the Political Constitution of the
p.(None): United Mexican States, and for due publication and observance, I issue this Decree in the Residence of
p.(None): Federal Executive Power, in Mexico City, Federal District, on the seventeenth day of the month of March two
p.(None): One thousand five.- Vicente Fox Quesada.- Rubric.- The Secretary of the Interior, Santiago Creel Miranda.- Rubric.
...
Social / education
Searching for indicator education:
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p.(None): identification established in the official Mexican norms that derive from this Law;
p.(None): 12 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): III. Participate, jointly with the Secretariats, in the issuance of official Mexican standards related to
p.(None): storage or storage of GMOs or products containing them in the customs premises of the
p.(None): National territory;
p.(None): IV. Give immediate notice to SEMARNAT, SAGARPA and / or SSA, about the probable commission of violations of
p.(None): precepts of this Law, regarding the import of GMOs, and
p.(None): V. Prevent the entry into the national territory of GMOs and products containing them, in cases where such
p.(None): organisms and products do not have permission and / or authorization, as appropriate, for importation, pursuant to this
p.(None): Law.
p.(None): The SHCP will exercise the previous powers, without prejudice to those conferred by customs legislation,
p.(None): applicable to the import of all merchandise.
p.(None): CHAPTER IV
p.(None): Coordination and Participation
p.(None): ARTICLE 19.- The CIBIOGEM is an Intersecretarial Commission whose purpose is to formulate and coordinate the
p.(None): Federal Public Administration policies related to the biosafety of GMOs, which will have the functions
p.(None): that establish the regulations that derive from this Law, in accordance with the following bases:
p.(None): I. The CIBIOGEM will be integrated by the head of the Secretariats of Agriculture, Livestock, Development
p.(None): Rural, Fishing and Food; Environment and Natural Resources; Health; Public education; Treasury and
p.(None): Public Credit, and Economy, as well as by the General Director of CONACyT;
p.(None): II. The CIBIOGEM will have a Presidency that will be rotating among the holders of the Secretariats of Agriculture,
p.(None): Livestock, Rural Development, Fisheries and Food, Environment and Natural Resources and Health, and whose
p.(None): exercise, functions and duration will be determined in the corresponding regulations. There will also be
p.(None): a Vice Presidency whose head will be the General Director of CONACyT, who will chair the sessions
p.(None): in the absence of the President, he will assist the Commission and the Executive Secretary in the exercise of their
p.(None): functions and will carry out the activities entrusted to it by CIBIOGEM itself in the terms established by the
p.(None): regulatory provisions derived from this Law;
p.(None): III. CIBIOGEM may invite other agencies to participate, with voice, in agreements and decisions
p.(None): of matters related to its purpose, as well as to the members of the Advisory Council;
p.(None): IV. The CIBIOGEM will have an Executive Secretary who will be appointed by the President of the
p.(None): Republic, at the proposal of the General Director of CONACyT, approved by CIBIOGEM itself. It will have the powers and
p.(None): powers that are determined in the regulatory provisions that derive from this system, and will execute and give
p.(None): follow up on the agreements of the Commission itself and exercise the other functions entrusted to it;
p.(None): V. The Executive Secretariat of the CIBIOGEM will have the organic structure approved in the terms of the
p.(None): applicable provisions, and will be considered an administrative unit by function of CONACyT, in accordance with
p.(None): the Organic Law of said parastatal entity, and
p.(None): SAW. The CIBIOGEM will also have a Technical Committee composed of coordinators, general directors or
...
p.(None): and in the official dissemination body of the respective local government.
p.(None): ARTICLE 27.- The governments of the federal entities will have permanent access to the information that is
p.(None): register in the National Biosafety Registry of Genetically Organized Organisms
p.(None): 15 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): Modified Likewise, the CIBIOGEM, through its Executive Secretariat, will notify the applications for permits from
p.(None): commercial release to the environment of GMOs, to the governments of the federal entities in which it is intended
p.(None): carry out this activity, so that they have knowledge of that situation and can issue their
p.(None): opinions in the terms of this Law. The notification must be made within twenty days following
p.(None): that in which the CIBIOGEM has received the corresponding permit application for registration in the Registry.
p.(None): CHAPTER VI
p.(None): From the Promotion to Scientific and Technological Research in Biosafety and Biotechnology
p.(None): ARTICLE 28.- The Federal Executive shall promote, support and strengthen scientific research and
p.(None): technology in biosafety and biotechnology through policies and instruments
p.(None): established in this Law and in the Law of Science and Technology. In biotechnology, these supports will be oriented
p.(None): to promote research and development and innovation projects, human resources training
p.(None): specialized and strengthening of groups and infrastructure of universities, education institutions
p.(None): superior and public research centers, which are carried out to solve productive needs
p.(None): country-specific and that directly benefit national producers.
p.(None): In the field of biosafety, research will be encouraged to obtain sufficient knowledge to assess
p.(None): the possible risks of GMOs in the environment, biological diversity, human health and animal health,
p.(None): vegetable and aquaculture; to generate socio-economic considerations of the effects of these organisms for the
p.(None): conservation and exploitation of biological diversity, and to assess and verify the information provided
p.(None): for the promoters. Likewise, the creation of human, institutional and infrastructure capacities will be promoted.
p.(None): for risk assessment and monitoring.
p.(None): ARTICLE 29.- To achieve the promotion of scientific and technological research in the field of
p.(None): Biosafety and biotechnology will establish a program for the development of biosafety and biotechnology
p.(None): which will be considered as a program whose formulation will be in charge of CONACyT based on the proposals that
p.(None): present the Secretariats and other agencies and entities of the Federal Public Administration that support or
p.(None): carry out scientific research and technological development. In this process opinions will be taken into account
p.(None): and proposals of the scientific, academic, technological and productive sector communities, convened by the Forum
p.(None): Scientific and Technological Consultant, and of the CIBIOGEM.
p.(None): Said program will be part of the Special Program of Science and Technology established by the Law of Science and
p.(None): Technology.
p.(None): ARTICLE 30.- The program for the development of biosafety and biotechnology must contain, at least,
...
Searching for indicator educational:
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p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Biosafety, monitoring, control and emergency systems and measures, and
p.(None): V. Studies on possible risks to human health or the environment and biological diversity.
p.(None): Access to the information referred to in the previous sections shall be governed, in addition, by the provisions
p.(None): applicable in matters of access to government public information.
p.(None): CHAPTER VIII
p.(None): Export of GMOs destined for release to the environment in other countries
p.(None): ARTICLE 72.- Those interested in exporting GMOs that are destined for their release to the environment in other countries, will notify
p.(None): by itself, as determined in the regulations that derive from this Law, its intention to
p.(None): export said organisms to the competent authorities of the respective country Such notification only
p.(None): it will be carried out in cases where international treaties and agreements in which the
p.(None): United Mexican States are a party, establish that requirement to export to the country of
p.(None): try. The information that the interested party attaches to the notification referred to in this article must be exact,
p.(None): Reliable and in accordance with what is established in these international treaties and agreements.
p.(None): THIRD TITLE
p.(None): Confined Use and Notices
p.(None): CHAPTER I
p.(None): Confined use
p.(None): ARTICLE 73.- The confined use of GMOs may be for educational purposes, of
p.(None): scientific and technological, industrial or commercial research.
p.(None): ARTICLE 74.- Those who carry out confined use activities subject to the requirement of
p.(None): presentation of notice in the terms of this Law, must comply with the following:
p.(None): I. Keep a log book of the activities of confined use they carry out, which must be provided
p.(None): to the corresponding Secretariats when they request it;
p.(None): II. Apply confinement measures whose execution should be adapted to scientific knowledge and
p.(None): more modern and advanced technicians in risk management and treatment, final disposal and
p.(None): elimination of GMO residues generated during the activity, and
p.(None): III. In the case of the use confined for teaching or scientific research purposes and
p.(None): technology, integrate an internal biosafety commission and apply the principles of good practice of
p.(None): scientific research, as well as the biosafety rules defined by the internal commission of
p.(None): Biosafety This internal commission will be responsible for the security of the facilities and the
p.(None): good practices and safety in the management of GMOs used in the indicated activity.
p.(None): The official Mexican norms that derive from this Law will establish:
p.(None): A) The requirements and general characteristics that must be contained in the log book referred to in this
p.(None): article, for each type of activity;
p.(None): B) The requirements and characteristics related to confinement, treatment, final disposal, destruction and
p.(None): GMO waste disposal;
p.(None): 26 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): this Law and the official Mexican norms that derive from it;
p.(None): V. Participate in the preparation and issuance of the lists referred to in this Law;
p.(None): SAW. Suspend the effects of permits, when you have scientific and technical information
p.(None): supervening from which it is deduced that the permitted activity entails higher risks than expected, which may
p.(None): negatively affect animal, plant or aquaculture health, biological diversity or human health. These two
p.(None): last cases, at the express request of the SEMARNAT or the SSA, depending on their competence under this Law, with
p.(None): support in technical and scientific elements;
p.(None): VII. Order and apply the relevant security or urgent application measures, with technical bases and
p.(None): scientific and in the precautionary approach, in the terms of this Law;
p.(None): VIII. Inspect and monitor compliance with this Law, its regulations and official Mexican standards that
p.(None): derive from it;
p.(None): IX. Impose administrative sanctions on people who violate the precepts of this Law, their
p.(None): Mexican regulations and official regulations that derive from it, without prejudice, where appropriate, of the penalties
p.(None): correspond when the acts or omissions constituting infractions to this system are also constitutive
p.(None): of crime, and of the civil liability that may result, and
p.(None): X. The others that this Law confers.
p.(None): ARTICLE 14.- In the cases in which SEMARNAT is responsible for the knowledge, processing and resolution of a
p.(None): permission application, in the case of wild and forest species, you must send the respective file to the
p.(None): SAGARPA to issue the corresponding opinion.
p.(None): ARTICLE 15.- In cases that fall within the competence of SAGARPA, SEMARNAT will
p.(None): The following will apply:
p.(None): I. Issue the corresponding biosafety opinion, prior to the resolution of SAGARPA, as a result of the
p.(None): analysis and evaluation of risks that you carry out based on the study developed and presented by the
p.(None): interested, about the possible risks that the activity with GMOs in question may cause to the environment and
p.(None): biological diversity, in the case of applications for permits for experimental release of said organisms, or
p.(None): based on the results reports and the information that the interested parties attach to their requests for
p.(None): permits for release in pilot program and for commercial release;
p.(None): II. Require SAGARPA to suspend the effects of the permits issued by said Secretariat, when available
p.(None): of scientific and technical information from which it is deduced that the permitted release involves risks
p.(None): higher than expected that may adversely affect the environment and biological diversity, and
p.(None): III. The exercise of the powers established in sections I, II, IV, V, VII and VIII of article 11 of this
p.(None): Law.
p.(None): 11 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): The biosafety opinion referred to in section I of this article shall be binding, prior to
p.(None): granting of the corresponding permits to be issued to SAGARPA, and will be issued in the terms of article 66 of
p.(None): this law.
p.(None): ARTICLE 16.- It is the responsibility of the SSA to exercise the following powers in relation to GMOs:
p.(None): I. Participate in the formulation and implementation of the general biosafety policy;
p.(None): II. Evaluate on a case-by-case basis the studies prepared and presented by stakeholders on safety and possible
p.(None): risks of GMOs subject to authorization under the terms of Title Five of this Law;
p.(None): III. Resolve and issue the authorizations of GMOs referred to in the previous section;
p.(None): IV. Participate in the preparation and issuance of the lists referred to in this Law;
p.(None): V. Order and apply the relevant security or urgent application measures, with technical and scientific basis and
p.(None): in the precautionary approach, in the terms of this Law;
p.(None): SAW. Request from SEMARNAT or SAGARPA, as appropriate, with support from technical and scientific elements, the
p.(None): suspension of the effects of the release of GMOs to the environment, when available
p.(None): information from which it is deduced that the activity permitted by these Secretariats involves risks greater than
p.(None): expected to affect human health;
p.(None): VII. Inspect and monitor compliance with this Law, its regulations and official standards
p.(None): Mexican
p.(None): VIII. Impose administrative sanctions on people who violate the provisions of this Law, its regulations and
p.(None): Mexican official norms that derive from this Law, without prejudice, where appropriate, of the corresponding penalties when the
p.(None): acts or omissions constituting violations of this system are also constitutive of crime, and of the
...
p.(None): regulations that derive from this Law.
p.(None): ARTICLE 20.- The Scientific Advisory Council of the CIBIOGEM is created, which will function as a mandatory consultation body
p.(None): of CIBIOGEM itself in technical and scientific aspects in modern biotechnology and biosafety of GMOs. I know
p.(None): integrate by a group of experts in different disciplines, from centers, institutions of
p.(None): research, academies or scientific societies of recognized prestige, which will exercise their function to
p.(None): personal title, regardless of the institution, association or company of which they are part or in
p.(None): the one that provide their services. These experts will expressly express in commitment letter, at the time of being
p.(None): designated as members of the Scientific Advisory Board, not having any conflict of interest.
p.(None): The selection of the members of the Scientific Advisory Board will be made through a public call issued
p.(None): jointly the CONACyT and the Scientific and Technological Consultative Forum foreseen in the Law of Science and Technology.
p.(None): Among the functions of the Advisory Council, the formulation of research protocols, analysis and
p.(None): methodologies and technical opinions, which may be remunerated. The specific functions of the Advisory Council
p.(None): and the mechanisms so that the renewal of its members is progressive and staggered, will be established in the
p.(None): regulatory provisions derived from this Law. The technical opinions issued by the Council
p.(None): Scientific Consultant should be considered by the CIBIOGEM in the decisions adopted.
p.(None): ARTICLE 21.- The CIBIOGEM Joint Consultative Council is created, which will act as an auxiliary organ of
p.(None): consultation and opinion of CIBIOGEM itself. It will be made up of representatives of associations, chambers or companies of the
p.(None): private, social and productive sectors. Its fundamental function will be to know and comment on social aspects,
p.(None): economic, and other aspects related to regulatory and promotion policies, as well as
p.(None): priorities in the standardization and improvement of procedures and procedures regarding
p.(None): Biosecurity of GMOs. The specific functions of the Joint Advisory Council and the mechanisms for the
p.(None): incorporation of its members will be established by the CIBIOGEM.
p.(None): ARTICLE 22.- The CIBIOGEM will issue its rules of operation in which the mechanisms of
p.(None): participation so that members and representatives of the academic, scientific, technological, social and
p.(None): productive, of recognized prestige and experience in the subjects directly related to the
p.(None): activities that are the subject of this Law, may participate through opinions, studies and consultations in the
p.(None): knowledge and evolution of biosafety policies and promotion of biosafety research and
p.(None): biotechnology, as well as to receive opinions, studies and consultations in these matters.
p.(None): ARTICLE 23.- CONACyT will have in its budget the necessary resources for the development of the
p.(None): activities of the CIBIOGEM, the Executive Secretariat and the Scientific Advisory Board, in accordance with
p.(None): budget authorized under the terms of the applicable provisions. These resources will be
p.(None): administered and exercised by the Executive Secretary of the CIBIOGEM.
p.(None): The programs, projects, supports, as well as the other actions that are carried out by the application of
p.(None): the present Law and other provisions in the matter, in which federal resources are exercised, are
...
p.(None): fiscal resources provided by the agencies and entities for this purpose, third party resources and income that
p.(None): The concept of rights determines the tax provisions, which derive from acts carried out in application of this Law.
p.(None): SECOND TITLE
p.(None): Permissions
p.(None): CHAPTER I
p.(None): Common Provisions
p.(None): ARTICLE 32.- The following activities will be required for permission:
p.(None): I. The experimental release into the environment, including the importation for that activity, of one or more GMOs;
p.(None): II. The release into the environment in a pilot program, including the import for that activity, of GMOs,
p.(None): Y
p.(None): III. The commercial release to the environment, including the import for that activity, of GMOs.
p.(None): ARTICLE 33.- Once the corresponding Secretariats receive a request for permission to release to the environment
p.(None): of GMOs, and as long as it complies with the information and requirements established in this Law, they must
p.(None): send it to the Registry for their respective registration and publicity. Once the above is done, the Secretariat
p.(None): to which it corresponds to resolve the request for the release of GMOs to the environment, will put
p.(None): public provision of said request, for public consultation, and must observe the forecasts on
p.(None): confidentiality established in this Law. Said Secretariat may make use of the means it deems
p.(None): suitable for the purpose of making the respective permit application available to the public.
p.(None): Any person, including the governments of the federal entities in which it is intended to carry out the
p.(None): respective release, may express their opinion, which must be supported by technical and
p.(None): 17 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): scientifically, within a period of no more than twenty business days from the date on which the
p.(None): respective request be made available to the public in the terms of this article.
p.(None): Opinions that are issued in accordance with the provisions of the preceding paragraph will be considered
p.(None): by the corresponding Secretariats for the establishment of additional biosecurity measures, in case
p.(None): it is appropriate to issue the release of GMOs to the corresponding environment, in the terms of this Law.
p.(None): ARTICLE 34.- The corresponding Secretariat shall issue its resolution, duly founded and motivated, once
p.(None): analyzed the information and documentation provided by the interested party, the opinion or opinion they had issued
p.(None): the Secretariats that are responsible for issuing them in accordance with this Law and, where appropriate, the
p.(None): GMO authorization issued by the SSA under the terms of this system. The corresponding Secretariat
p.(None): in its resolution you can:
p.(None): I. Issuing the permit for carrying out the release activity to the environment in question,
p.(None): being able to establish additional monitoring, control, prevention and security measures to those proposed by
p.(None): the interested party in the permit application, or
p.(None): II. Deny permission in the following cases:
p.(None): A) When the request does not comply with the provisions of this Law or the official Mexican regulations such as
p.(None): requirements for the granting of the permit;
p.(None): B) When the information provided by the interested party, including that related to the possible risks that could
p.(None): cause GMOs to be false, incomplete or insufficient, or
p.(None): C) When the corresponding Secretariat concludes that the risks that may be presented by the GMOs in question,
p.(None): negatively affect human health or biological diversity, or animal, plant or aquaculture health,
p.(None): may cause serious or irreversible damage.
p.(None): ARTICLE 35.- The deadlines established in this Law for the resolution of a request for a release permit at
p.(None): GMO environment, whether experimental or pilot program, will be extendable, in case the interested party does not count
p.(None): with the authorization issued by the SSA in the terms of this ordinance, as long as said
p.(None): authorization is required for the issuance of the respective permit.
...
p.(None): commercial contained in international treaties and agreements to which the United Mexican States are a party.
p.(None): ARTICLE 64.- The interested party may submit additionally to the study of possible risks, other studies or
p.(None): considerations that analyze both the contribution of the GMO to the solution of environmental, social problems,
p.(None): productive or otherwise, the socioeconomic considerations that exist regarding the release of GMOs
p.(None): to the environment, as an assessment of the risks of alternative technology options to contend with the
p.(None): specific problem for which the GMO was designed. These analyzes should be supported by
p.(None): scientific and technical evidence, in the background on use, production and consumption, and may be
p.(None): considered by the competent Secretariats as additional elements to decide on the release
p.(None): experimental to the environment, and consequent releases to the environment in pilot and commercial program, respectively,
p.(None): of the GMO in question.
p.(None): ARTICLE 65.- The characteristics and requirements of the studies to evaluate the possible risks shall be established.
p.(None): in the official Mexican norms that derive from this Law.
p.(None): CHAPTER IV
p.(None): Of the opinions
p.(None): ARTICLE 66.- The opinions that the SEMARNAT must issue will only be required in the case of
p.(None): experimental release activities, pilot program release and commercial release of GMOs
p.(None): that are the responsibility of SAGARPA. These opinions must be issued within a period of sixty days from
p.(None): after SEMARNAT receives the administrative file sent by SAGARPA. This term includes
p.(None): both the issuance of the corresponding opinion, and its referral to SAGARPA. SAGARPA will issue the permit of
p.(None): release of GMOs to the appropriate environment, provided that the opinion issued by SEMARNAT is favorable.
p.(None): 24 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): CHAPTER V
p.(None): On the Reconsideration of Negative Resolutions
p.(None): ARTICLE 67.- Those interested in whom the corresponding Secretariat has denied the requested permission may
p.(None): request said Secretariat to reconsider the respective resolution, when it is considered that:
p.(None): I. There has been a change in circumstances that may influence the outcome of the study of possible
p.(None): risks on which the resolution was based, or
p.(None): II. New relevant scientific or technical information is available from which it follows that
p.(None): Possible risks identified are not those originally intended.
p.(None): The competent Secretariat may issue a resolution within two months. In case of not doing so, it
p.(None): will consider the reconsideration dismissed.
p.(None): ARTICLE 68.- The reconsideration referred to in the preceding article does not constitute any remedy or means of defense,
p.(None): and may be promoted by interested parties regardless of whether they enforce the means of challenge established in
p.(None): This Law against the resolution that affects them.
p.(None): CHAPTER VI
p.(None): From the Permit Review
p.(None): ARTICLE 69.- The corresponding Secretariat, at any time and on the basis of new information
p.(None): scientific or technical about the possible risks that GMOs can cause to public health or the environment
p.(None): and to biological diversity, they may review the permits granted and, where appropriate, suspend their effects or revoke
...
p.(None): necessary technicians who support the environmental benefit that is intended to be obtained, and such activities are allowed
p.(None): by SEMARNAT in the terms of this Law.
p.(None): For the purposes of the provisions of the preceding paragraph, it is prohibited to carry out activities with GMOs in the areas
p.(None): core of protected natural areas.
p.(None): In the event that any center of origin or center of genetic diversity is located within a natural area
p.(None): protected, the declarations of creation and the management programs of these areas will be modified in the
p.(None): terms of the legislation of the matter, as the determinations referred to in Article 86 of
p.(None): This Law
p.(None): CHAPTER III
p.(None): GMO Free Zones
p.(None): ARTICLE 90.- GMO-free zones may be established for the protection of agricultural products
p.(None): organic and others of interest to the requesting community, in accordance with the following general guidelines:
p.(None): 29 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): I. Free zones will be established in the case of GMOs of the same species to which they are
p.(None): Produce through production processes of organic agricultural products, and be proven scientifically and technically
p.(None): that their coexistence is not viable or that they would not comply with the regulatory requirements for their certification;
p.(None): II. These areas will be determined by SAGARPA through agreements that will be published in the Journal.
p.(None): Official of the Federation, previous opinion of the CIBIOGEM, with the opinion of the National Commission for
p.(None): Knowledge and Use of Biodiversity, taking into account what is established in official regulations
p.(None): Mexican relative to organic agricultural products;
p.(None): III. The determination of free zones will be made based on the following requirements:
p.(None): A. It will be made at the written request of the communities concerned, through their legal representative;
p.(None): B. This request must be accompanied by the favorable opinion of the governments of the entities
p.(None): federation and municipal governments of places or regions to be determined as free zones;
p.(None): C. Evaluations of the effects that GMOs may cause to the production processes of
p.(None): organic agricultural products or biodiversity, through which it is demonstrated,
p.(None): scientifically and technically, that its coexistence is not viable or does not meet the regulatory requirements for its
p.(None): certification, in accordance with the official Mexican standards issued by SAGARPA. The evaluations
p.(None): mentioned shall be carried out as established by said Secretariat in official Mexican standards, and
p.(None): IV. SAGARPA will establish in the agreements the security measures that may be adopted in GMO-free zones,
p.(None): in order to ensure adequate protection of organic agricultural products.
p.(None): FIFTH TITLE
p.(None): On the Protection of Human Health in relation to GMOs
p.(None): CHAPTER I
p.(None): Of GMO Authorizations
p.(None): ARTICLE 91.- The GMOs subject to authorization are the following:
p.(None): I. Those that are intended for human use or consumption, including grains;
p.(None): II. Those that are used for food processing for human consumption;
p.(None): III. Those with public health purposes, and
p.(None): IV. Those that are destined to bioremediation.
p.(None): For the purposes of this Law, GMOs for human use or consumption are also considered to be those for consumption
p.(None): animal and that can be consumed directly by the human being.
p.(None): ARTICLE 92.- The request for authorization of a GMO must be accompanied by the following requirements:
p.(None): I. The study of the possible risks that the human use or consumption of the GMO in question could represent the
...
p.(None): animal, vegetable or aquaculture, or
p.(None): III. GMOs not allowed and / or unauthorized into the environment are accidentally released.
p.(None): In these cases, the measures may be the following:
p.(None): A. Temporary, partial or total closure of the places and / or facilities in which they are handled or
p.(None): store GMOs or develop activities that give rise to the assumptions that give rise to taxation
p.(None): of the measure;
p.(None): B. The precautionary assurance of GMOs, in addition to goods, vehicles, utensils and instruments directly
p.(None): related to the action or omission that gives rise to the measure;
p.(None): C. The temporary, total or partial suspension of the activity that motivates the imposition of the measure;
p.(None): 36 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): D. The repatriation of GMOs to their country of origin;
p.(None): E. The performance of the necessary actions and measures to avoid continuing to present the assumptions that
p.(None): motivate the imposition of the measure, and
p.(None): F. The destruction of GMOs in question, at the expense of the interested party, for which the following should be addressed:
p.(None): a) Proceed only if the risks or damages are serious or irreparable, and only by
p.(None): the imposition of this measure is possible to avoid, mitigate or mitigate the risks or damages that motivated it;
p.(None): b) To determine the imposition of the measure, the competent Secretariat must issue an opinion, based on technical and
p.(None): scientifically, by means of which the origin of the destruction of the GMO in question is justified,
p.(None): having to make it known to the interested party, so that the latter within five days exposes
p.(None): what is convenient for you and, where appropriate, provide the evidence you have, and
p.(None): c) As long as the competent Secretariat dictates the corresponding resolution, it may order, in advance,
p.(None): the precautionary assurance of GMOs, which can be carried out by the Secretariat itself or through the
p.(None): interested.
p.(None): Likewise, the competent Secretariat that imposes the measures referred to in this article may promote
p.(None): before the other competent Secretariats, the execution of some or some measures established in
p.(None): Other systems.
p.(None): ARTICLE 116.- When the competent Secretariats order any of the measures provided for in the previous article,
p.(None): they will indicate to the interested party the actions that must be carried out to correct the irregularities that motivated
p.(None): the imposition of said measures, as well as the deadlines for their realization, so that once these have been fulfilled,
p.(None): Order the withdrawal of the measures imposed.
p.(None): If the interested party will refuse to carry out the actions to correct the irregularities that
p.(None): motivated the imposition of the measure (s) in question, the Secretariat that has imposed them
p.(None): will perform immediately, with full charge to the reluctant interested party.
...
p.(None): imposed by the competent Secretariats;
p.(None): 40 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Confiscation of instruments, copies, organisms obtained or directly related products
p.(None): with the offenses committed;
p.(None): V. The suspension or revocation of permits and corresponding authorizations;
p.(None): SAW. Administrative arrest for up to thirty-six hours, and
p.(None): VII. Prohibition of experimental release, pilot program release or
p.(None): marketing of GMOs or the products that contain them.
p.(None): ARTICLE 121.- Regardless of the provisions of the preceding Article, any person who, with full knowledge of
p.(None): that these are GMOs, cause damage to third parties in their property or to their health, due to the improper use or handling of said
p.(None): agencies, will be responsible and will be obliged to repair them under the terms of federal civil legislation.
p.(None): The same obligation will be assumed by the person who damages the environment or biological diversity, due to improper use or handling
p.(None): of GMOs, for which the provisions of Article 203 of the General Law of Ecological Balance and the
p.(None): Environmental Protection
p.(None): Those directly affected in their property may request the judge to request the Secretariat
p.(None): competent so that, through its respective scientific technical committee that establishes according to this
p.(None): order, prepare a technical opinion whose purpose is to prove the existence of the damage, and serve as the basis for the judge
p.(None): to determine, where appropriate, the form of its repair. The technical opinion issued will not generate any cost to
p.(None): Applicants charge.
p.(None): In the case of damage to the environment or biological diversity, the SEMARNAT, through the
p.(None): Federal Attorney for Environmental Protection, will exercise the responsibility action, being able to do it in any
p.(None): in the following ways:
p.(None): I. Ex officio, based on the file relating to inspection and surveillance acts that have been finalized,
p.(None): the commission of infractions to this Law has been determined and this determination has not been distorted by any
p.(None): means of challenge, or
p.(None): II. By complaint, filed by members of the affected community, of acts that could contravene the
p.(None): established in this Law and other provisions that emanate from it. The complaint must be accompanied by the information
p.(None): technical and scientific support, with the participation of the Scientific Advisory Board of the CIBIOGEM,
p.(None): previous opinion of the National Commission for the Knowledge and Use of Biodiversity.
p.(None): In the cases referred to in the previous sections, the Federal Attorney General's Office
p.(None): Ambiente will proceed to exercise the action of responsibility based on the technical opinion that for such effect elaborates
p.(None): the scientific technical committee of the SEMARNAT. For the formulation of the opinion, the scientific technical committee will evaluate
p.(None): the information and the elements available to the Federal Attorney for Environmental Protection, whether
p.(None): that work in the administrative file or those provided by the complainants, respectively, and
p.(None): determine, where appropriate, the existence of the damage. They will be competent to know about the actions of
p.(None): liability for damage to the environment or biological diversity in the terms of this
p.(None): Article, the district courts in civil matters, in accordance with the territorial jurisdiction established in the
p.(None): respective provisions.
p.(None): The administrative sanctions established in the previous Article shall apply without prejudice, where appropriate,
p.(None): of the corresponding penalties when the acts or omissions constituting violations of this Law, are also
p.(None): constitutive of crime in accordance with the applicable provisions of the Federal Criminal Code.
p.(None): 41 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): ARTICLE 122.- They are additionally applicable to this Chapter regarding administrative responsibilities,
p.(None): the provisions of the Single Chapter of the Fourth Title of the Federal Law of Administrative Procedure, with the exception
p.(None): of article 70-A of said system.
p.(None): TITLE TENTH
p.(None): Review Resource
...
General/Other / Other Country
Searching for indicator another country:
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p.(None): III. In the case of the use confined for teaching or scientific research purposes and
p.(None): technology, integrate an internal biosafety commission and apply the principles of good practice of
p.(None): scientific research, as well as the biosafety rules defined by the internal commission of
p.(None): Biosafety This internal commission will be responsible for the security of the facilities and the
p.(None): good practices and safety in the management of GMOs used in the indicated activity.
p.(None): The official Mexican norms that derive from this Law will establish:
p.(None): A) The requirements and general characteristics that must be contained in the log book referred to in this
p.(None): article, for each type of activity;
p.(None): B) The requirements and characteristics related to confinement, treatment, final disposal, destruction and
p.(None): GMO waste disposal;
p.(None): 26 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): C) The driving conditions that are required in the various forms of confined use of said organisms, and
p.(None): D) Actions to be taken in case of accidental release of GMOs.
p.(None): ARTICLE 75.- The storage or deposit of GMOs or products containing them, which is carried out at customs
p.(None): of the national territory, will be subject to what the respective official Mexican standards that
p.(None): jointly issue the competent Secretariats, with the participation of the SHCP.
p.(None): ARTICLE 76.- The transport of GMOs or products containing them, as well as the transit of said organisms and
p.(None): Products throughout the national territory, when they have another country as their destination, will be governed by the rules
p.(None): Mexican officials who jointly issue the competent Secretariats, with the participation
p.(None): of the Ministry of Communications and Transportation.
p.(None): CHAPTER II
p.(None): Of the Notices
p.(None): ARTICLE 77.- The notice is the communication that the subjects indicated in
p.(None): this Law, to SEMARNAT or SAGARPA, as appropriate according to this order, with respect to the
p.(None): Confined use of GMOs in the cases established in this chapter.
p.(None): ARTICLE 78.- Notices must be submitted to SEMARNAT or SAGARPA, in accordance with the attributions of this Law.
p.(None): confers them, in the official formats that are issued for this purpose. The content of the formats
p.(None): They will determine said Secretariats, with the prior approval of the Federal Regulatory Improvement Commission. In sayings
p.(None): formats will determine the information and documentation that the interested party must submit. The formats must be
p.(None): publish in the Official Gazette of the Federation.
p.(None): ARTICLE 79.- Require notice submission:
p.(None): I. GMOs that are managed, generated and produced for scientific and technological teaching and research purposes;
p.(None): II. The integration of internal biosafety commissions, including the name of the
p.(None): responsible for said commissions;
p.(None): III. The first use of laboratories or specific teaching or research facilities
p.(None): scientific and technological in which GMOs are managed, generated and produced;
p.(None): IV. The production of GMOs used in industrial processes, and
p.(None): V. The first use of specific facilities where the GMOs referred to occur
p.(None): the previous fraction.
p.(None): ARTICLE 80.- The import of GMOs for use is also required for presentation of notice.
...
p.(None): interested.
p.(None): Likewise, the competent Secretariat that imposes the measures referred to in this article may promote
p.(None): before the other competent Secretariats, the execution of some or some measures established in
p.(None): Other systems.
p.(None): ARTICLE 116.- When the competent Secretariats order any of the measures provided for in the previous article,
p.(None): they will indicate to the interested party the actions that must be carried out to correct the irregularities that motivated
p.(None): the imposition of said measures, as well as the deadlines for their realization, so that once these have been fulfilled,
p.(None): Order the withdrawal of the measures imposed.
p.(None): If the interested party will refuse to carry out the actions to correct the irregularities that
p.(None): motivated the imposition of the measure (s) in question, the Secretariat that has imposed them
p.(None): will perform immediately, with full charge to the reluctant interested party.
p.(None): In the event that the interested party carries out security measures or urgently applied or remedies irregularities
p.(None): incurred, prior to the competent Secretariat imposing some or some of the sanctions
p.(None): established in this Law, said Secretariat shall consider such situation as mitigating the infraction.
p.(None): committed.
p.(None): ARTICLE 117.- In case of accidental releases of GMOs that are verified in the national territory,
p.(None): and that they could have significant adverse effects on the biological diversity or human health of
p.(None): another country, the competent Secretariat shall notify such situation to the corresponding authority of the country that could
p.(None): be affected by such release. Such notification must include:
p.(None): I. Information on the estimated quantities and the characteristics and / or important features of the GMO;
p.(None): II. Information on the circumstances and the estimated date of the accidental release, as well as the use of the
p.(None): GMO in the national territory;
p.(None): III. Information available on possible adverse effects for biological diversity and human health;
p.(None): 37 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Information available on possible regulatory measures, attention and risk control, and
p.(None): V. A point of contact for additional information.
p.(None): Notwithstanding the foregoing, the Secretariats, within the scope of their powers under this Law, will carry out the
p.(None): actions and measures necessary to minimize any risk or adverse effect that the GMOs released
p.(None): They could accidentally cause. Such actions and measures will be ordered by the Secretariats to whom there are
p.(None): caused the accidental release of GMOs to the environment, who must comply immediately. In case
p.(None): Otherwise, the Secretariats will proceed in accordance with the provisions of the second paragraph of the previous article.
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): said permits, in accordance with the procedures established by the regulations that derive from this
p.(None): Law, when considering as causes that:
p.(None): I. There is a change in the circumstances of the activities that may influence the outcome of the study of the
p.(None): assessment of possible risks on which the permit was based, or
p.(None): II. Have additional scientific or technical information that could modify any
p.(None): conditions, limitations or permit requirements.
p.(None): CHAPTER VII
p.(None): Confidentiality
p.(None): ARTICLE 70.- Those interested may clearly identify in their permit application, that information
p.(None): that should be considered confidential according to the industrial property or copyright regime. The
p.(None): Corresponding secretariat shall be subject to the provisions of the laws of the matter and shall refrain from ordering to register and
p.(None): to provide third parties with information and data that are protected by these laws.
p.(None): ARTICLE 71.- They shall not be confidential:
p.(None): I. The general description of GMOs;
p.(None): II. The identification of the interested party or person responsible for the activity;
p.(None): III. The purpose and place or places of the activity;
p.(None): 25 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Biosafety, monitoring, control and emergency systems and measures, and
p.(None): V. Studies on possible risks to human health or the environment and biological diversity.
p.(None): Access to the information referred to in the previous sections shall be governed, in addition, by the provisions
p.(None): applicable in matters of access to government public information.
p.(None): CHAPTER VIII
p.(None): Export of GMOs destined for release to the environment in other countries
p.(None): ARTICLE 72.- Those interested in exporting GMOs that are destined for their release to the environment in other countries, will notify
p.(None): by itself, as determined in the regulations that derive from this Law, its intention to
p.(None): export said organisms to the competent authorities of the respective country Such notification only
p.(None): it will be carried out in cases where international treaties and agreements in which the
p.(None): United Mexican States are a party, establish that requirement to export to the country of
p.(None): try. The information that the interested party attaches to the notification referred to in this article must be exact,
p.(None): Reliable and in accordance with what is established in these international treaties and agreements.
p.(None): THIRD TITLE
p.(None): Confined Use and Notices
p.(None): CHAPTER I
p.(None): Confined use
p.(None): ARTICLE 73.- The confined use of GMOs may be for educational purposes, of
p.(None): scientific and technological, industrial or commercial research.
p.(None): ARTICLE 74.- Those who carry out confined use activities subject to the requirement of
...
p.(None): of the Federal Law of Administrative Procedure, except for the provisions of the previous article.
p.(None): Twelve eleventh
p.(None): Infractions, Sanctions and Responsibilities
p.(None): CHAPTER I
p.(None): Of the Infractions
p.(None): ARTICLE 119.- The person who, in full, incurs administrative violations of the provisions of this Law.
p.(None): knowledge that it is about GMOs:
p.(None): I. Perform activities with GMOs without the respective permits and authorizations;
p.(None): II. Perform activities with GMOs in breach of the terms and conditions established in the permits and
p.(None): respective authorizations;
p.(None): III. Perform activities of confined use of GMOs, without presenting the notices in the terms
p.(None): established in this Law;
p.(None): IV. Carry out activities with GMOs that are subject or exempt from the notice submission, in breach of the
p.(None): other provisions of this Law, its regulations and the official Mexican norms that derive therefrom,
p.(None): that are applicable to the activity in question or that are common to all activities in
p.(None): biosecurity matter;
p.(None): V. Present to the competent Secretariats, information and / or documentation referred to in this
p.(None): system that is false, including the one related to the possible risks that activities with GMOs could
p.(None): cause human health or biological diversity;
p.(None): SAW. Breaches the sanitary, monitoring, control and prevention measures indicated by those interested in the information
p.(None): and documentation provided to obtain the respective permits and authorizations, and those established by the
p.(None): Secretariats in their own permits and authorizations;
p.(None): VII. Breaches the control and response measures in case of emergency indicated by the interested parties
p.(None): in their studies of the possible risks that activities with GMOs may cause to human health or
p.(None): biological diversity or animal, plant or aquaculture health;
p.(None): VIII. Breaches the obligation to inform or inform the Secretariats, in the cases established in
p.(None): this law;
p.(None): 38 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IX. Breaches the obligation to adopt and implement additional biosecurity requirements and measures
p.(None): determined by the Secretariats, in cases of confined use activities subject to notice, in
p.(None): so be determined;
p.(None): X. Failure to review, implement or adopt new sanitary, monitoring, control and
p.(None): prevention, in the cases in which the competent Secretariats so determine in accordance with the provisions of this Law;
p.(None): XI Carry out activities with GMOs or with any other body whose purpose is the manufacture and / or use of
p.(None): biological weapons;
p.(None): XII. Make releases of GMOs in centers of origin and genetic diversity, outside the cases
p.(None): established in this Law;
p.(None): XIII Carry out activities with GMOs in the protected natural areas indicated in this Law, outside the cases
p.(None): established by it;
p.(None): XIV Failure to inform the SEMARNAT or SAGARPA, according to their field of competence
p.(None): pursuant to this Law, through the corresponding report, the results of the release
p.(None): experimental or pilot program releases, which have the respective permit;
p.(None): XV. Import GMOs that are prohibited in the country of origin or are classified as not allowed for
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): before the other competent Secretariats, the execution of some or some measures established in
p.(None): Other systems.
p.(None): ARTICLE 116.- When the competent Secretariats order any of the measures provided for in the previous article,
p.(None): they will indicate to the interested party the actions that must be carried out to correct the irregularities that motivated
p.(None): the imposition of said measures, as well as the deadlines for their realization, so that once these have been fulfilled,
p.(None): Order the withdrawal of the measures imposed.
p.(None): If the interested party will refuse to carry out the actions to correct the irregularities that
p.(None): motivated the imposition of the measure (s) in question, the Secretariat that has imposed them
p.(None): will perform immediately, with full charge to the reluctant interested party.
p.(None): In the event that the interested party carries out security measures or urgently applied or remedies irregularities
p.(None): incurred, prior to the competent Secretariat imposing some or some of the sanctions
p.(None): established in this Law, said Secretariat shall consider such situation as mitigating the infraction.
p.(None): committed.
p.(None): ARTICLE 117.- In case of accidental releases of GMOs that are verified in the national territory,
p.(None): and that they could have significant adverse effects on the biological diversity or human health of
p.(None): another country, the competent Secretariat shall notify such situation to the corresponding authority of the country that could
p.(None): be affected by such release. Such notification must include:
p.(None): I. Information on the estimated quantities and the characteristics and / or important features of the GMO;
p.(None): II. Information on the circumstances and the estimated date of the accidental release, as well as the use of the
p.(None): GMO in the national territory;
p.(None): III. Information available on possible adverse effects for biological diversity and human health;
p.(None): 37 of 44
p.(None): BIOSEURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): New Law DOF 03-18-2005
p.(None): IV. Information available on possible regulatory measures, attention and risk control, and
p.(None): V. A point of contact for additional information.
p.(None): Notwithstanding the foregoing, the Secretariats, within the scope of their powers under this Law, will carry out the
p.(None): actions and measures necessary to minimize any risk or adverse effect that the GMOs released
p.(None): They could accidentally cause. Such actions and measures will be ordered by the Secretariats to whom there are
p.(None): caused the accidental release of GMOs to the environment, who must comply immediately. In case
p.(None): Otherwise, the Secretariats will proceed in accordance with the provisions of the second paragraph of the previous article.
p.(None): ARTICLE 118.- The provisions of the Single Chapter of Title Five are supplementary to this Chapter.
p.(None): of the Federal Law of Administrative Procedure, except for the provisions of the previous article.
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| access to information | Access to information |
| another country | Other Country |
| authority | Relationship to Authority |
| crime | Illegal Activity |
| criminal | criminal |
| education | education |
| educational | education |
| emergency | Public Emergency |
| family | Motherhood/Family |
| indigenous | Indigenous |
| influence | Drug Usage |
| nation | stateless persons |
| native | Indigenous |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| political | political affiliation |
| property | Property Ownership |
| restricted | Incarcerated |
| single | Marital Status |
| stem cells | stem cells |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| education | ['educational'] |
| educational | ['education'] |
| indigenous | ['native'] |
| native | ['indigenous'] |
| party | ['political'] |
| political | ['party'] |
Trigger Words
capacity
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input