0A4F4F9BD490A749D5437F821CF06DF1

Regulation of the Biosafety Law on Genetically Modified Organisms

http://www.diputados.gob.mx/LeyesBiblio/regley/Reg_LBOGM.pdf

http://leaux.net/URLS/ConvertAPI Text Files/1C0ECA653F9F943304D585A5FAD9CE6F.en.txt

Examining the file media/Synopses/1C0ECA653F9F943304D585A5FAD9CE6F.html:

This file was generated: 2020-07-14 06:14:08

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

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Indigenous	indigenous	1
Political	Indigenous	native	1
Political	political affiliation	party	10
Political	political affiliation	political	1
Health	Drug Usage	substance	1
Social	Access to Social Goods	access	2
Social	Incarcerated	restricted	2
Social	Linguistic Proficiency	language	4
Social	Marital Status	single	9
Social	Property Ownership	property	1
Social	Religion	conviction	1
Social	education	education	2
Social	gender	gender	1
Social	parents	parents	2
Social	philosophical differences/differences of opinion	opinion	43
General/Other	Other Country	another country	1
General/Other	Relationship to Authority	authority	8

Political / Indigenous

Searching for indicator indigenous:

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p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): Last DOF Reform 06-03-2009
p.(None): V. The dependencies and entities of the federal public administration and the institutes of
p.(None): national research and people who develop biotechnology, who generate relevant documents on
p.(None): biotechnology,
p.(None): SAW. The competent Secretariat that admits a permit application, for the purposes of section VI of the article
p.(None): previous, and
p.(None): VII. The competent Secretariat that receives a communication in terms of Article 59 of these Regulations,
p.(None): within five business days after the measures to be taken by the competent Secretariat have been decided.
p.(None): For the purposes of section II of the preceding article, the Executive Secretary shall request the Secretariats and the
p.(None): CIBIOGEM consultation and opinion bodies the necessary information to integrate statistics.
p.(None): The Secretariats and the consultation and opinion bodies of the CIBIOGEM must respond to these requests
p.(None): entering in the information system referred to in this article, the data and documents required by the
p.(None): Executive Secretary.
p.(None): Chapter II
p.(None): From monitoring to biosafety information
p.(None): Article 53. The CIBIOGEM will prepare and publish in its Internet portal an annual report of the
p.(None): general situation in the country regarding biosafety, considering at least the statistics derived from
p.(None): the information included in the Registry on applications, permits, authorizations and notices, as well as
p.(None): that information on the actions implemented in compliance with the Cartagena Protocol.
p.(None): Article 54. Consultation and participation of indigenous peoples and communities settled in areas where
p.(None): The release of GMOs is intended to be carried out in accordance with the mechanisms determined for this purpose by the
p.(None): CIBIOGEM
p.(None): Chapter III Registration
p.(None): Article 55. The Registry is part of the National Biosafety Information System, will have character
p.(None): public and will be in charge of the Executive Secretariat. Its purpose is the registration of information related to
p.(None): activities with GMOs, as well as of the agencies themselves subject to the provisions of the Law and this
p.(None): Regulation.
p.(None): Article 56. The following shall be registered in the Registry:
p.(None): I. Requests for permits and authorizations;
p.(None): II. Resolutions of permits and authorizations, distinguishing which GMOs are imported; as well as resolutions to
p.(None): those referred to in article 37, section IV, of this Regulation;
p.(None): III. Suspensions and revocation;
p.(None): IV. Notices of confined use;
p.(None): V. Additional requirements and measures for the notices indicated in article 84 of the Law;
p.(None): 24 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): SAW. The communications referred to in article 59 of these Regulations, and
p.(None): VII. The others that establish the applicable provisions.
p.(None): TENTH TITLE
p.(None): From the Lists of GMOs Single Chapter
p.(None): Article 57. The lists of GMOs referred to in articles 103 and 104 of the Law shall be issued.
p.(None): by the competent Secretariats and HEALTH, through a notice that will be published in the Official Gazette of the Federation.
...

Searching for indicator native:

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p.(None): promoters, terminators and others that affect DNA function;
p.(None): 4. Detailed description of the transformation method and number of coding sequences;
p.(None): 5. Regulation of gene expression, identification of any open reading frame within DNA
p.(None): inserted or created by modifications of the adjacent DNA on the chromosome;
p.(None): 6. Stability of the modification, and
p.(None): 7. Intermediary host organizations.
p.(None): e) When a marker gene was used as a selection element for modified organisms:
p.(None): 1. Reasons for choosing said marker, and
p.(None): 2. If it is a gene that confers antimicrobial resistance, its use must be justified and the
p.(None): no choice of another marker gene.
p.(None): f) Regarding the GMO:
p.(None): 1. Organization of the inserted genetic material and the methods used for its characterization;
p.(None): 2. In the event that truncated portions have been inserted, their size should be established.
p.(None): action of the expression product of the inserted genes;
p.(None): 15 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): 3. Gene products or analysis of transcripts or products expressed to identify any
p.(None): new substance that may be present in the food or, in the case of organisms
p.(None): employees with the purpose of bioremediation in the environment or public health any side effects
p.(None): in the biochemistry, physiology and metabolism of GMO;
p.(None): 4. Stability of genetic construction under different process conditions and the expression of new
p.(None): materials or modification of native materials, and
p.(None): 5. Characterization, sensitivity and specificity of the designated action on the products of expression of the
p.(None): inserted transgenes.
p.(None): g) When genetic modifications alter the expression of natural constituents or metabolites,
p.(None): You should report possible side effects on the related metabolic pathways;
p.(None): h) On the expression of transgenes:
p.(None): 1. Kinetics of gene expression in the modified organism;
p.(None): 2. In the case of vegetables, level of expression in the different structures of the plant;
p.(None): 3. Demonstrate whether the desired effects have been achieved with the modification and if all the features
p.(None): expressed are inherited in a stable manner in the amount of propagation necessary for use in the
p.(None): food production, bioremediation or public health and in accordance with the laws of inheritance;
p.(None): 4. Indicate whether there are data to suggest that one or more genes of the recipient organism have been affected by the
p.(None): modifications or by the process of genetic exchange, and
p.(None): 5. Size and number of copies of all detectable inserts, both fully inserted and
p.(None): truncated
p.(None): i) GMO detection and identification methods, including infrastructure required for identification,
p.(None): Reagents required for the extraction, purification and detection methodologies of their materials,
p.(None): sequences of primers and probes specific event to detect transgenic DNA, at least 300 bp at one side of the site
p.(None): of insertion, specific antibodies for the exogenous protein, and level of reliability of each method. Append
p.(None): samples of the positive and negative controls they use. In the case of microorganisms
p.(None): genetically modified, the identification method that allows its detection should be described in detail
...

Political / political affiliation

Searching for indicator party:

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p.(None): X. UTM: Mercator Universal Transversal Projection, a system used to convert coordinates
p.(None): spherical geographies in flat Cartesian coordinates.
p.(None): Article 3. In the absence of express provision in this ordinance, the provisions of the Federal Law of
p.(None): Administrative Procedure.
p.(None): Article 4. When a procedure is carried out before the competent Secretariat or HEALTH, where appropriate, it shall be
p.(None): attach a copy of the payment of fees, at the time indicated by the corresponding Law.
p.(None): SECOND TITLE
p.(None): Permissions for Activities with GMOs
p.(None): Chapter I
p.(None): Permission request
p.(None): Article 5. Those who intend to carry out the activities provided for in article 32 of the Law, must present before the
p.(None): Competent Secretariat, a written request, in the format issued by the competent Secretariats,
p.(None): accompanied by the information referred to in articles 16, 17 and 19 of this Regulation. Shall
p.(None): An application must be submitted for each GMO, in original and copy. The information contained in the application will be the following:
p.(None): I. Name, denomination or company name of the promoter and, where appropriate, name of the legal representative;
p.(None): II. Address to hear and receive notifications, as well as the name of the person or persons
p.(None): authorized to receive them;
p.(None): III. Email address to receive notifications, in case the promoter wishes to be notified
p.(None): hereby;
p.(None): IV. Modality of the requested release and the reasons that give rise to the petition;
p.(None): V. Point out the body of the competent Secretariat, to which the request is addressed;
p.(None): SAW. Place and date, and
p.(None): VII. Signature of the interested party or legal representative, or where appropriate, fingerprint.
p.(None): The promoter must attach to his application the documents that prove his personality.
p.(None): In case you have the identification number in the register of accredited persons, you can cite it in the
p.(None): in writing, without the need to record the information provided in sections I, II and VII of this article, nor the
p.(None): documents with which you prove your personality, except the information provided in sections III, IV, V and VI, of
p.(None): this article.
p.(None): The promoter will not be obliged to provide data or deliver additional sets of documents delivered
p.(None): previously to the competent Secretariat, as long as you indicate the identification data
p.(None): 2 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): of the letter in which they were summoned or with which they were accompanied and the new procedure is carried out before said Unit.
p.(None): In addition to the aforementioned requirements, the attached data and documents must be submitted.
p.(None): contain the information and requirements established in articles 42, 43, 50, 51, 55 and 56 of the Law, and 16, 17 and 19
p.(None): of this Regulation, according to the corresponding release modality.
p.(None): The request must be accompanied by electronic storage devices that will contain the
p.(None): electronic version of the request submitted in writing, as well as all the data and attached documents that
p.(None): contain the information and requirements established in the Law, this Regulation and the NOM.
p.(None): Said electronic version must be presented in the format that by means of an agreement issued
p.(None): jointly by SEMARNAT and SAGARPA and published in the Official Gazette of the Federation is determined.
p.(None): Article 6. The integrated application must be submitted in Spanish. If you are in a language
p.(None): differently, the versions in both languages must be attached and, if there is controversy regarding their content,
p.(None): what is stated in the source language will prevail.
p.(None): Article 7. The interested party may clearly identify within the information provided, whatever
p.(None): considered confidential, according to articles 70 and 71 of the Law.
p.(None): Article 8. The competent Secretariat will review the integrated application, within ten business days
p.(None): following receipt, and if it does not comply with the data or requirements
p.(None): corresponding, you must prevent interested parties in writing and only once, to remedy the omission, in a
p.(None): term not exceeding twenty business days, counted from the day following the notification.
p.(None): After the corresponding period has elapsed without prevention, the process will be discarded.
p.(None): For the purposes of the provisions of article 44 of the Law, it is understood that the integrated application was
p.(None): received and the information is complete, in cases where once submitted it is not done prevention or done it is
p.(None): attended by the promoter, without prejudice to the powers conferred by article 34, section II of the Law a
p.(None): the competent Secretariat.
p.(None): Article 9.- If the competent Secretariat does not carry out the prevention in the terms indicated in the
p.(None): previous article may not dismiss the process arguing that it is incomplete.
p.(None): Article 10. The competent Secretariat may only require additional information, within twenty days
p.(None): to the admission of the integrated application, in the cases referred to in article 63 of the Law.
p.(None): Article 11. The promoter will have a term of twenty working days, counted from the day
p.(None): after the notification has taken effect, to meet the requirement referred to in the
p.(None): Article 10 of this Regulation.
p.(None): After this period has elapsed without the requestor having submitted the requested information, the competent Secretariat may
p.(None): deny permission, in accordance with the provisions of section II of article 34 of the Law.
...

p.(None): official proving that the GMO is allowed according to the legislation of the country of origin, at least for its
p.(None): commercial release, translated into Spanish;
p.(None): IX. The competent Secretariat, if deemed necessary, may require a simple copy of the
p.(None): applicable legislation in force in the export country translated into Spanish, and
p.(None): X. The information determined in each case by the NOM.
p.(None): Chapter III
p.(None): The resolution of permit applications and their validity
p.(None): Article 20. The competent Secretariat shall resolve to the promoter its request for a release permit including the
p.(None): concerning the import, within the following maximum deadlines, counted from the business day following that
p.(None): such request is admitted:
p.(None): I. For experimental release to the environment six months;
p.(None): 11 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): II. For release to the environment in a three-month pilot program, and
p.(None): III. For commercial release to the environment four months.
p.(None): It is understood that the request is admitted in cases where the request was received and the information is complete,
p.(None): in accordance with the provisions of article 8, last paragraph, of this Regulation.
p.(None): Article 21. In terms of the provisions of article 35 of the Law, only if the
p.(None): HEALTH authorization and this has not yet been issued, the deadline to resolve the permit application will be extended from
p.(None): so that the competent Secretariat resolves within ten business days after the interested party has
p.(None): credited in the respective file obtaining such authorization.
p.(None): Article 22. The validity of the permits to carry out the experimental release and in a pilot program will be proposed
p.(None): by the promoter with the corresponding justification, in accordance with articles 16, section VIII, and 17,
p.(None): Section IX of this Regulation.
p.(None): The competent Secretariat may limit the proposed validity considering the elements of the file.
p.(None): In the case of permission to carry out the commercial release, the validity will be indefinite. The permits will contain
p.(None): expressly, the validity of them.
p.(None): Once the corresponding permission has been granted, the competent Secretariat may modify its validity, when
p.(None): of the information provided by the interested party conclude that serious and irreversible damages to
p.(None): biological diversity or plant, animal or aquaculture health, and must identify in the resolution
p.(None): damages to be avoided, and establish the scientific reasons to justify the modification.
p.(None): THIRD TITLE
p.(None): Of the authorizations
p.(None): Chapter I General Provisions
p.(None): Article 23. Those who intend to obtain an authorization from any of the GMOs referred to in article 91 of the
p.(None): Law, must submit to HEALTH, a written request accompanied by the information to which
p.(None): Article 31 of this Regulation refers. The application must be submitted in original and a simple copy
p.(None): for acknowledgment
p.(None): Article 24. An application must be submitted for each GMO, containing the following information:
p.(None): I. Name, denomination or company name of the promoter and, where appropriate, name of the legal representative;
p.(None): II. Address to hear and receive notifications, as well as the name of the person or persons
p.(None): authorized to receive them;
p.(None): III. Email address to receive notifications, in case the promoter wishes to be notified
p.(None): hereby;
p.(None): 12 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): IV. Type of the GMO, in accordance with the fractions of article 91 of the Law, and the reasons that give rise to the
p.(None): petition;
p.(None): V. Indicate the Health body, to which the request is addressed;
p.(None): SAW. Place and date, and
p.(None): VII. Signature of the interested party or legal representative, or where appropriate, fingerprint.
p.(None): The promoter must attach to his application the documents that prove his personality.
p.(None): In case you have the identification number in the register of accredited persons, you can cite it in the
p.(None): in writing, without the need to record the information provided in sections I, II and VII of this article, nor the
p.(None): documents with which you prove your personality, except the information provided in sections III, IV, V and VI, of
p.(None): this article.
p.(None): The promoter will not be obliged to provide data or deliver additional sets of documents delivered
p.(None): prior to HEALTH, as long as they indicate the identification data of the document in which they were cited or with which
p.(None): they were accompanied and the new procedure is carried out before said Unit.
p.(None): The request must be accompanied by electronic storage devices that will contain the
p.(None): electronic version of the request submitted in writing, as well as all the data and attached documents that
p.(None): contain the information and requirements established in the Law, this Regulation and the NOM.
p.(None): Said electronic version must be submitted in the format that, through an agreement published in the Journal
p.(None): Federation official determine HEALTH.
p.(None): Article 25. The documentation and information referred to in articles 23 and 24 of this
p.(None): Regulations must be submitted in Spanish. If you are in a language other than Spanish, they must be attached
p.(None): both versions and, if there is controversy as to their content, what is stated in the version in the
p.(None): Source language.
p.(None): The interested party may clearly identify within the information provided, whatever
p.(None): considered confidential, according to articles 70 and 71 of the Law.
p.(None): Article 26. Requests for authorization shall be submitted to HEALTH with the annexes
p.(None): corresponding. The date and time of receipt shall be recorded in the original of the application and in the acknowledgment of receipt.
p.(None): Article 27. The term referred to in article 95 of the Law to issue the authorization shall begin to run
p.(None): from the business day following the one in which the application is admitted.
p.(None): Article 28. Once the application is accepted, HEALTH will evaluate the data and documents presented with it, to
p.(None): determine if they comply with the information and requirements established in the Law, this Regulation and
p.(None): other applicable provisions. If necessary, it will prevent the promoter, in writing and only once so that
p.(None): remedy the omission.
p.(None): The deadline to carry out the evaluation and require the promoter of the information or requirements that do not conform to the
p.(None): provided in the Law, the Regulations and other applicable provisions, will be thirty business days, counted
p.(None): from the business day following the submission of the application for the procedure.
p.(None): 13 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): Article 29. The promoter will have a period of twenty business days from the day
p.(None): after the notification has taken effect, to meet the requirement referred to in the
p.(None): previous article. During this period, the resolution deadlines of the request for
...

p.(None): cited enzymatic digestion, at pH and heat stability or processing, demonstrate their allergenic potential,
p.(None): should provide data from the IgE cross-reactivity analysis between a new expression protein and
p.(None): a known allergen;
p.(None): n) In the case of events with a combination of genes, the parental events involved in the generation of said
p.(None): event must be previously authorized. The information to be delivered in this particular type of GMOs
p.(None): It includes:
p.(None): 1. Specification of the following categories:
p.(None): i. Category 1. Parentals with unrelated phenotypic characteristics;
p.(None): ii. Category 2. Parents who have related characteristics but their action derives from routes
p.(None): different or included in different modes of action, and
p.(None): iii Category 3. Parents with characteristics related to activity on the same metabolic pathway or
p.(None): biosynthetic
p.(None): 2. Procedure applied to obtain the event with a combination of genes, including
p.(None): Genotypic and phenotypic characteristics of their parental lines:
p.(None): i. Metabolic pathways in which each of the transgenic proteins encoded in the event act
p.(None): with combination of genes;
p.(None): ii. Studies on the stability of inserted genes, and
p.(None): iii. Substantial equivalence studies, and
p.(None): II. In case of authorization requests from a GMO to be able to import them for the purposes for which
p.(None): Article 91 of the Law refers to the information and documentation proving that the GMO is authorized
p.(None): according to the legislation of the country of origin or, failing that, the interested party's declaration of non-existence
p.(None): of said situation and exposure of the elements of consideration that support the one that HEALTH can resolve the
p.(None): authorization request, and
p.(None): III. The other requirements determined by HEALTH in the NOMs derived from the Law.
p.(None): Article 32. HEALTH will decide on the request for authorization within a period not exceeding six months from
p.(None): the business day following the one that admits the request.
p.(None): It is understood that the request is admitted in cases where the request was received and the information is complete,
p.(None): in accordance with the provisions of article 30, second paragraph, of these Regulations.
p.(None): 18 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): FOURTH TITLE
p.(None): On the reconsideration of negative resolutions and the review of permits and authorizations
p.(None): Chapter I
p.(None): On the reconsideration of negative resolutions
p.(None): Article 33. For the case established in articles 67 and 98 of the Law, the request for
p.(None): reconsideration of a negative resolution on a permit or authorization must be presented
p.(None): before the authority that issued it, and must provide the elements on which the claim of the
p.(None): promoter in the same reconsideration brief.
p.(None): In the notice of reconsideration, the promoter must indicate:
p.(None): I. The identification data of the resolution and the date it was issued and
p.(None): II. The arguments and elements that demonstrate that your request adheres to the assumptions provided for in article 67
p.(None): of the law.
...

p.(None): previous article.
p.(None): Article 39.- During the evaluation process referred to in section III of article 37 of the
p.(None): this Regulation, SEMARNAT will review its opinion, based on the new scientific or technical information and, if
p.(None): necessary, will modify it. The opinion issued by SEMARNAT will be binding for the resolution of the procedure of
p.(None): SAGARPA review.
p.(None): Article 40. The review of permits and authorizations practiced by the relevant Secretariats and HEALTH in their
p.(None): respective fields of competence and in the terms of the Law and these Regulations, will be carried out independently
p.(None): of security measures or urgent application that could be determined by the Secretariats themselves according to
p.(None): to article 115 of the Law.
p.(None): FIFTH TITLE
p.(None): On the import and export of GMOs that are destined to be released into the environment Single Chapter
p.(None): 20 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): Article 41. Prior to the importation of GMOs that are intended to be released into the environment, the
p.(None): permission corresponding to the corresponding release, which will have the effect of import permit in the
p.(None): terms established by law.
p.(None): Article 42. The notification referred to in article 72 of the Law must be made in writing,
p.(None): complying with the requirements established in the international treaties and agreements to which Mexico is a party, as well
p.(None): as required by the authorities of the country of destination of the GMOs.
p.(None): SIXTH TITLE
p.(None): Of the internal biosafety commissions Single Chapter
p.(None): Article 43. The internal biosafety commissions referred to in article 74, section III, of
p.(None): the Law, will be integrated by a minimum of three people who have experience and knowledge in the activities
p.(None): of confined use of GMOs.
p.(None): Article 44.- The internal biosecurity commissions will be permanent and their members may be replaced by
p.(None): in accordance with the internal rules that are issued for its operation and that must be approved by the instance
p.(None): empowered of those who carry out activities of confined use of GMOs.
p.(None): Article 45. Internal biosafety commissions shall:
p.(None): I. Issue biosafety rules, which must contain, among other aspects, the prevention
p.(None): of accidental releases and monitoring of compliance with the rules and good practices;
p.(None): II. Define the good practices of scientific research that must be observed;
p.(None): III. Provide scientific and technical advice to those responsible for utilization activities
p.(None): confined to the GMO, within the scope of its material competence;
p.(None): IV. Issue technical opinion on the biosafety aspects of teaching and research
p.(None): proposals, prior review of the facilities and materials to be used for the safe handling of the
p.(None): GMOs and methods involved;
p.(None): V. Ensure the security of the facilities in which the activities of confined use are carried out, as well
p.(None): such as safety in the management of the GMO, and
p.(None): SAW. Guarantee the physical and biological integrity of the exposed personnel and of the persons who carry out the use
p.(None): confined
...

p.(None): Last DOF Reform 06-03-2009
p.(None): impose in its area of competence the security or urgent application measures deemed necessary for
p.(None): contend with that situation.
p.(None): In addition to the communication indicated in the first paragraph of this article, within three business days
p.(None): following the knowledge of the situation described in the previous paragraph, the permit holder or who
p.(None): carry out confined use activities must submit a written notice to the Secretariat that issued the
p.(None): permission or received permission, which will contain:
p.(None): I. Identification data of the permit or notice;
p.(None): II. The polygon where the accidental release occurred, located in UTM coordinates;
p.(None): III. Circumstances and estimated date of accidental release;
p.(None): IV. Estimated quantities of the GMO that was accidentally released;
p.(None): V. Information available to the permit holder or who carries out confined use activities on the
p.(None): possible adverse effects for biological diversity and human health;
p.(None): SAW. Attention and risk control measures applied and will be applied by the permit holder or whoever performs
p.(None): confined utilization activities, and
p.(None): VII. Name and phone number of the person who will serve as the contact point.
p.(None): Article 60. The Secretariats, in their field of competence, may order some or some of the security measures
p.(None): or of urgent application provided for in article 115 of the Law. Once the inspection certificate has been received by the
p.(None): ordering authority for inspection and surveillance acts, by personal notification or by mail
p.(None): certificate with acknowledgment of receipt, will require the interested party to execute, at their own expense and cost, the security measures or
p.(None): urgently applicable, indicating the deadlines for compliance.
p.(None): Article 61. When repatriation is imposed as a security measure, the interested party must cover the
p.(None): costs thereof, being able to transfer the expenses incurred against the person responsible for the infraction.
p.(None): Article 62. If, as a result of an inspection and surveillance visit, the imposition of measures of
p.(None): security or urgent application, the inspected must notify the competent Secretariat the
p.(None): compliance with each one, within a term of five business days counted from the expiration date of the term
p.(None): granted for the execution of each one of them.
p.(None): Article 63. When the competent Secretariat engages the alleged offender and he appears by
p.(None): written accepting the irregularities in the inspection record, the Secretariat will proceed, within
p.(None): Twenty following business days, to issue the respective resolution.
p.(None): Article 64. The administrative resolution issued shall indicate, in addition to the infractions and sanctions,
p.(None): the measures to be taken to correct the deficiencies or irregularities observed during
p.(None): the inspection and the period granted to comply with them, under the terms of the Law.
p.(None): TENTH SECOND
p.(None): On the Special Corn Protection Regime Single Chapter
p.(None): 26 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): Article 65. Activities related to genetically modified corn shall be subject to the present.
p.(None): Title, to the other general provisions applicable to GMOs, as well as to the provisions of other instruments that
p.(None): establish authority.
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p.(None): 3. Infectivity, virulence factors and range of receptors potentially susceptible to being infected.
p.(None): d) About the introduction of genetic material:
p.(None): 1. Function of the introduced DNA;
p.(None): 2. Location and orientation of genetic material;
p.(None): 3. For all introduced DNA, the DNA sequence or restriction map must be described,
p.(None): characterization of all genetic components including marker genes, regulatory elements,
p.(None): promoters, terminators and others that affect DNA function;
p.(None): 4. Detailed description of the transformation method and number of coding sequences;
p.(None): 5. Regulation of gene expression, identification of any open reading frame within DNA
p.(None): inserted or created by modifications of the adjacent DNA on the chromosome;
p.(None): 6. Stability of the modification, and
p.(None): 7. Intermediary host organizations.
p.(None): e) When a marker gene was used as a selection element for modified organisms:
p.(None): 1. Reasons for choosing said marker, and
p.(None): 2. If it is a gene that confers antimicrobial resistance, its use must be justified and the
p.(None): no choice of another marker gene.
p.(None): f) Regarding the GMO:
p.(None): 1. Organization of the inserted genetic material and the methods used for its characterization;
p.(None): 2. In the event that truncated portions have been inserted, their size should be established.
p.(None): action of the expression product of the inserted genes;
p.(None): 15 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): 3. Gene products or analysis of transcripts or products expressed to identify any
p.(None): new substance that may be present in the food or, in the case of organisms
p.(None): employees with the purpose of bioremediation in the environment or public health any side effects
p.(None): in the biochemistry, physiology and metabolism of GMO;
p.(None): 4. Stability of genetic construction under different process conditions and the expression of new
p.(None): materials or modification of native materials, and
p.(None): 5. Characterization, sensitivity and specificity of the designated action on the products of expression of the
p.(None): inserted transgenes.
p.(None): g) When genetic modifications alter the expression of natural constituents or metabolites,
p.(None): You should report possible side effects on the related metabolic pathways;
p.(None): h) On the expression of transgenes:
p.(None): 1. Kinetics of gene expression in the modified organism;
p.(None): 2. In the case of vegetables, level of expression in the different structures of the plant;
p.(None): 3. Demonstrate whether the desired effects have been achieved with the modification and if all the features
p.(None): expressed are inherited in a stable manner in the amount of propagation necessary for use in the
p.(None): food production, bioremediation or public health and in accordance with the laws of inheritance;
p.(None): 4. Indicate whether there are data to suggest that one or more genes of the recipient organism have been affected by the
p.(None): modifications or by the process of genetic exchange, and
p.(None): 5. Size and number of copies of all detectable inserts, both fully inserted and
p.(None): truncated
p.(None): i) GMO detection and identification methods, including infrastructure required for identification,
p.(None): Reagents required for the extraction, purification and detection methodologies of their materials,
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p.(None): f) Declaration on the existence of effects on biological diversity and the environment that may be
p.(None): derive from the release of the GMO;
p.(None): g) Description of one or more methods of identification of the specific GMO event, including levels
p.(None): of sensitivity and reproducibility, with the express manifestation of the promoter that the methods of
p.(None): Identification are those recognized by the GMO developer for its detection;
p.(None): h) Potential existence of GMO gene flow to related species;
p.(None): i) Recent bibliography of reference to the data presented, and
p.(None): j) The others established by the NOMs derived from the Law.
p.(None): IV. Measures and procedures for monitoring the activity and biosafety to be carried out:
p.(None): a) Measures and procedures for monitoring the activity:
p.(None): 1. Detailed monitoring plan;
p.(None): 2. Post-GMO monitoring strategies, in order to detect any
p.(None): interaction between the GMO and relevant present species, directly or indirectly, in the area or
p.(None): areas where the release is intended, when they exist, and
p.(None): 3. Strategies for the detection of GMOs and their subsequent presence in the area or areas where it is intended to carry out the
p.(None): liberation and neighboring areas, once the liberation is concluded.
p.(None): b) Biosecurity measures and procedures:
p.(None): 1. Measures and procedures to prevent the release and dispersion of GMOs outside the area or areas where
p.(None): it tries to realize the liberation;
p.(None): 7 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): 2. Measures and procedures to reduce the access of dispersion vector organisms, or of
p.(None): persons who are not authorized to enter the area of liberation to said zone or zones;
p.(None): 3. Measures for the eradication of GMOs in areas other than those allowed;
p.(None): 4. Measures for the isolation of the area where the GMO is intended to be released experimentally;
p.(None): 5. Measures for the protection of human health and the environment, should a release event not occur
p.(None): desired, and
p.(None): 6. Methods for cleaning or final disposal of waste from release.
p.(None): The promoter must clearly distinguish the measures and procedures that will be carried out during the
p.(None): release of those that will be made after it.
p.(None): V. Background of release of the GMO in other countries, when this has been done, and must attach the information
p.(None): relevant when it is within reach of the promoter:
p.(None): a) Description of the area where the release was made;
p.(None): b) Effects of release on flora and fauna;
p.(None): c) Study of the possible risks of the release of GMOs presented in the country of origin, when it has been
p.(None): required by the authority of another country and have access to it. The description of the measures and
p.(None): established biosecurity monitoring procedures should be included in the study.
p.(None): d) In case the promoter considers it appropriate, other studies or considerations in which both are analyzed
p.(None): the contribution of the GMO to the solution of environmental, social, productive or other problems, as well as the
p.(None): socioeconomic considerations that exist regarding the release of GMOs to the environment. These analyzes
p.(None): they must be based on scientific and technical evidence, on the background on use, production and consumption,
p.(None): and may be considered by the relevant Secretariats as additional elements to decide on the
p.(None): experimental release to the environment, and consequent releases to the environment in pilot and commercial program,
p.(None): respectively, of the GMO in question, and
p.(None): e) In case of import, legalized or apostilled copy of the authorizations or official documentation proving
p.(None): that the GMO is allowed under the legislation of the country of origin, at least for experimental release,
p.(None): Translated into Spanish. The competent Secretariat, if deemed necessary, may require a simple copy of the
p.(None): Applicable legislation in force in the export country translated into Spanish.
p.(None): SAW. Considerations on the risks of technological alternatives available to contend
p.(None): with the problem for which the GMO was built, in case such alternatives exist;
p.(None): VII. Authorization number issued by HEALTH when the GMO has public health purposes or is destined for
p.(None): bioremediation In case of not having the authorization at the time of
p.(None): 8 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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
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p.(None): confined
p.(None): SEVENTH TITLE
p.(None): From the scientific technical committees Single Chapter
p.(None): Article 46. The scientific technical committees that may support the Secretariats regarding the
p.(None): applications for permits and authorizations, as well as regarding notices, will be made up of people with knowledge
p.(None): scientific or technological who have experience in the evaluation, control and risk management of GMOs, and
p.(None): either to human health, the environment and biological diversity or to
p.(None): 21 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): animal, plant and aquaculture health, or in modern biotechnology applied to research, creation and development of
p.(None): This type of organisms.
p.(None): The designation of the members corresponds to the Head of the Secretariat to which they provide support, or
p.(None): to the public servant in which he delegates the power.
p.(None): Article 47. The committees referred to in the previous article shall issue their rules of operation, after validation of
p.(None): the corresponding Secretariats.
p.(None): Article 48. Scientific technical committees shall conduct themselves with strict adherence to the principles of objectivity,
p.(None): impartiality and legality in the issuance of opinions and opinions that are requested, observing
p.(None): the provisions on protection of confidential information contained in the respective legal systems.
p.(None): EIGHTH TITLE
p.(None): Of the restricted areas
p.(None): Single Chapter
p.(None): Of the centers of origin and genetic diversity
p.(None): Article 49. The agreements by which the centers of origin and genetic diversity to which are determined are determined
p.(None): Article 86 of the Law refers to must contain:
p.(None): I. List of species, including scientific and common name;
p.(None): II. Taxonomic classification;
p.(None): III. The polygonal area or geographic areas in UTM coordinates, and
p.(None): IV. The necessary measures for the protection of these species.
p.(None): The agreements will be promoted interchangeably by SEMARNAT or SAGARPA, and jointly issued by
p.(None): Both Secretariats
p.(None): NINTH TITLE
p.(None): About Biosafety Information
p.(None): Chapter I
p.(None): From the National Biosafety Information System
p.(None): Article 50. The National Biosafety Information System will be in charge of the Executive Secretariat. The
p.(None): Information that integrates the System will be available on the CIBIOGEM Internet portal and must be updated
p.(None): permanently.
p.(None): Article 51. The National Biosafety Information System shall contain:
p.(None): I. Registry information in accordance with the provisions of article 56 of this
p.(None): Regulation;
p.(None): II. National statistics on biosafety and GMO;
p.(None): III. The restricted areas and the municipality or municipalities where it is located, distinguishing:
p.(None): 22 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): a) Centers of origin and genetic diversity by species; in UTM coordinates;
p.(None): b) Protected natural areas of federal competence, in the coordinates established in its instruments of
p.(None): creation;
p.(None): c) Protected natural areas of local competence, in the coordinates established in their instruments of
p.(None): creation, in case the local authorities want these areas to be in the National System of
p.(None): Biosafety Information, and
p.(None): d) GMO free zones, in UTM coordinates.
p.(None): IV. Relevant reports and documents resulting from scientific, academic, work activities
p.(None): technicians or any other type of biosafety including the safety of GMOs, made by people
p.(None): physical or moral, national or foreign;
p.(None): V. Information on the formats of the notices referred to in article 78 of the Law and the
p.(None): communications referred to in article 59 of these Regulations, the measures taken by the permit holders or
p.(None): by those who carry out confined use activities and the measures taken by the authority, to meet the
p.(None): accidental releases or any modification in the release that may increase the possible
p.(None): risks to the environment and biological diversity when conducting experimental release activities or
p.(None): pilot program release;
p.(None): SAW. The information related to the permit applications, for the purposes of the provisions of article 33 of the Law, and
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p.(None): in writing, without the need to record the information provided in sections I, II and VII of this article, nor the
p.(None): documents with which you prove your personality, except the information provided in sections III, IV, V and VI, of
p.(None): this article.
p.(None): The promoter will not be obliged to provide data or deliver additional sets of documents delivered
p.(None): previously to the competent Secretariat, as long as you indicate the identification data
p.(None): 2 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): of the letter in which they were summoned or with which they were accompanied and the new procedure is carried out before said Unit.
p.(None): In addition to the aforementioned requirements, the attached data and documents must be submitted.
p.(None): contain the information and requirements established in articles 42, 43, 50, 51, 55 and 56 of the Law, and 16, 17 and 19
p.(None): of this Regulation, according to the corresponding release modality.
p.(None): The request must be accompanied by electronic storage devices that will contain the
p.(None): electronic version of the request submitted in writing, as well as all the data and attached documents that
p.(None): contain the information and requirements established in the Law, this Regulation and the NOM.
p.(None): Said electronic version must be presented in the format that by means of an agreement issued
p.(None): jointly by SEMARNAT and SAGARPA and published in the Official Gazette of the Federation is determined.
p.(None): Article 6. The integrated application must be submitted in Spanish. If you are in a language
p.(None): differently, the versions in both languages must be attached and, if there is controversy regarding their content,
p.(None): what is stated in the source language will prevail.
p.(None): Article 7. The interested party may clearly identify within the information provided, whatever
p.(None): considered confidential, according to articles 70 and 71 of the Law.
p.(None): Article 8. The competent Secretariat will review the integrated application, within ten business days
p.(None): following receipt, and if it does not comply with the data or requirements
p.(None): corresponding, you must prevent interested parties in writing and only once, to remedy the omission, in a
p.(None): term not exceeding twenty business days, counted from the day following the notification.
p.(None): After the corresponding period has elapsed without prevention, the process will be discarded.
p.(None): For the purposes of the provisions of article 44 of the Law, it is understood that the integrated application was
p.(None): received and the information is complete, in cases where once submitted it is not done prevention or done it is
p.(None): attended by the promoter, without prejudice to the powers conferred by article 34, section II of the Law a
p.(None): the competent Secretariat.
p.(None): Article 9.- If the competent Secretariat does not carry out the prevention in the terms indicated in the
p.(None): previous article may not dismiss the process arguing that it is incomplete.
p.(None): Article 10. The competent Secretariat may only require additional information, within twenty days
p.(None): to the admission of the integrated application, in the cases referred to in article 63 of the Law.
p.(None): Article 11. The promoter will have a term of twenty working days, counted from the day
p.(None): after the notification has taken effect, to meet the requirement referred to in the
p.(None): Article 10 of this Regulation.
...

p.(None): IV. Type of the GMO, in accordance with the fractions of article 91 of the Law, and the reasons that give rise to the
p.(None): petition;
p.(None): V. Indicate the Health body, to which the request is addressed;
p.(None): SAW. Place and date, and
p.(None): VII. Signature of the interested party or legal representative, or where appropriate, fingerprint.
p.(None): The promoter must attach to his application the documents that prove his personality.
p.(None): In case you have the identification number in the register of accredited persons, you can cite it in the
p.(None): in writing, without the need to record the information provided in sections I, II and VII of this article, nor the
p.(None): documents with which you prove your personality, except the information provided in sections III, IV, V and VI, of
p.(None): this article.
p.(None): The promoter will not be obliged to provide data or deliver additional sets of documents delivered
p.(None): prior to HEALTH, as long as they indicate the identification data of the document in which they were cited or with which
p.(None): they were accompanied and the new procedure is carried out before said Unit.
p.(None): The request must be accompanied by electronic storage devices that will contain the
p.(None): electronic version of the request submitted in writing, as well as all the data and attached documents that
p.(None): contain the information and requirements established in the Law, this Regulation and the NOM.
p.(None): Said electronic version must be submitted in the format that, through an agreement published in the Journal
p.(None): Federation official determine HEALTH.
p.(None): Article 25. The documentation and information referred to in articles 23 and 24 of this
p.(None): Regulations must be submitted in Spanish. If you are in a language other than Spanish, they must be attached
p.(None): both versions and, if there is controversy as to their content, what is stated in the version in the
p.(None): Source language.
p.(None): The interested party may clearly identify within the information provided, whatever
p.(None): considered confidential, according to articles 70 and 71 of the Law.
p.(None): Article 26. Requests for authorization shall be submitted to HEALTH with the annexes
p.(None): corresponding. The date and time of receipt shall be recorded in the original of the application and in the acknowledgment of receipt.
p.(None): Article 27. The term referred to in article 95 of the Law to issue the authorization shall begin to run
p.(None): from the business day following the one in which the application is admitted.
p.(None): Article 28. Once the application is accepted, HEALTH will evaluate the data and documents presented with it, to
p.(None): determine if they comply with the information and requirements established in the Law, this Regulation and
p.(None): other applicable provisions. If necessary, it will prevent the promoter, in writing and only once so that
p.(None): remedy the omission.
p.(None): The deadline to carry out the evaluation and require the promoter of the information or requirements that do not conform to the
p.(None): provided in the Law, the Regulations and other applicable provisions, will be thirty business days, counted
p.(None): from the business day following the submission of the application for the procedure.
p.(None): 13 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): Article 29. The promoter will have a period of twenty business days from the day
p.(None): after the notification has taken effect, to meet the requirement referred to in the
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p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): REGULATION OF THE BIOSEGURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): New Regulation published in the Official Gazette of the Federation on March 19, 2008 CURRENT TEXT
p.(None): Last reform published DOF 06-03-2009
p.(None): On the margin a seal with the National Shield, which says: United Mexican States.- Presidency of the
p.(None): Republic.
p.(None): FELIPE DE JESÚS CALDERÓN HINOJOSA, President of the United Mexican States, in exercise of the faculty
p.(None): conferred on me by Article 89, section I, of the Political Constitution of the United Mexican States and with
p.(None): basis in articles 13, 32 bis, 34, 35, 38, and 39 of the Organic Law of the Federal Public Administration, and in
p.(None): the Law of Biosafety of Genetically Modified Organisms, I have been pleased to issue the following
p.(None): REGULATION OF THE BIOSEGURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): FIRST TITLE
p.(None): General provisions Single Chapter
p.(None): Article 1. The purpose of this regulation is to regulate the Biosafety Law of
p.(None): Genetically Modified Organisms, in order to provide their exact observance.
p.(None): Article 2. For the purposes of this Regulation, the definitions provided for in article 3 of the Law on
p.(None): Biosecurity of Genetically Modified Organisms and the following:
p.(None): I. Law: Law on Biosafety of Genetically Modified Organisms;
p.(None): II. Mexico: United Mexican States;
p.(None): III. NOM: Official Mexican Standard;
p.(None): IV. GMO for public health purposes: Those organisms whose genetic modification is aimed at
p.(None): generate mechanisms for the prevention or control of human diseases, except for those referred to in
p.(None): Article 6, section III, of the Law;
p.(None): V. Cartagena Protocol: The Cartagena Protocol on Biosafety to the Convention
p.(None): on Biological Diversity;
p.(None): SAW. HEALTH: The Ministry of Health;
p.(None): VII. Competent Secretariat: SEMARNAT and SAGARPA within the scope of their competences in accordance with the Law;
p.(None): VIII. Executive Secretariat: The Executive Secretariat of the CIBIOGEM;
p.(None): 1 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): IX. Integrated application: The data and attached documents, referred to in Article 5 of these Regulations, and
p.(None): X. UTM: Mercator Universal Transversal Projection, a system used to convert coordinates
p.(None): spherical geographies in flat Cartesian coordinates.
p.(None): Article 3. In the absence of express provision in this ordinance, the provisions of the Federal Law of
p.(None): Administrative Procedure.
...

p.(None): c) Suspend its effects, or
p.(None): d) Revoke it, and
p.(None): V. The reviewing Secretariat will have thirty business days to issue the respective resolution,
p.(None): which must be made known to the other Secretariats and to the holder of the permit or authorization object of
p.(None): the revision, except in the case of subsection a) of section IV of this article, in which case it is only due
p.(None): notify the holder of the permit or authorization.
p.(None): Article 38. When the permit has been granted by SAGARPA, and SEMARNAT has new scientific information
p.(None): or technique that allows establishing possible risks to the environment and biological diversity, this dependence
p.(None): It will inform SAGARPA so that it may initiate the review procedure referred to in the
p.(None): previous article.
p.(None): Article 39.- During the evaluation process referred to in section III of article 37 of the
p.(None): this Regulation, SEMARNAT will review its opinion, based on the new scientific or technical information and, if
p.(None): necessary, will modify it. The opinion issued by SEMARNAT will be binding for the resolution of the procedure of
p.(None): SAGARPA review.
p.(None): Article 40. The review of permits and authorizations practiced by the relevant Secretariats and HEALTH in their
p.(None): respective fields of competence and in the terms of the Law and these Regulations, will be carried out independently
p.(None): of security measures or urgent application that could be determined by the Secretariats themselves according to
p.(None): to article 115 of the Law.
p.(None): FIFTH TITLE
p.(None): On the import and export of GMOs that are destined to be released into the environment Single Chapter
p.(None): 20 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): Article 41. Prior to the importation of GMOs that are intended to be released into the environment, the
p.(None): permission corresponding to the corresponding release, which will have the effect of import permit in the
p.(None): terms established by law.
p.(None): Article 42. The notification referred to in article 72 of the Law must be made in writing,
p.(None): complying with the requirements established in the international treaties and agreements to which Mexico is a party, as well
p.(None): as required by the authorities of the country of destination of the GMOs.
p.(None): SIXTH TITLE
p.(None): Of the internal biosafety commissions Single Chapter
p.(None): Article 43. The internal biosafety commissions referred to in article 74, section III, of
p.(None): the Law, will be integrated by a minimum of three people who have experience and knowledge in the activities
p.(None): of confined use of GMOs.
p.(None): Article 44.- The internal biosecurity commissions will be permanent and their members may be replaced by
p.(None): in accordance with the internal rules that are issued for its operation and that must be approved by the instance
p.(None): empowered of those who carry out activities of confined use of GMOs.
p.(None): Article 45. Internal biosafety commissions shall:
p.(None): I. Issue biosafety rules, which must contain, among other aspects, the prevention
p.(None): of accidental releases and monitoring of compliance with the rules and good practices;
p.(None): II. Define the good practices of scientific research that must be observed;
p.(None): III. Provide scientific and technical advice to those responsible for utilization activities
p.(None): confined to the GMO, within the scope of its material competence;
p.(None): IV. Issue technical opinion on the biosafety aspects of teaching and research
p.(None): proposals, prior review of the facilities and materials to be used for the safe handling of the
p.(None): GMOs and methods involved;
p.(None): V. Ensure the security of the facilities in which the activities of confined use are carried out, as well
p.(None): such as safety in the management of the GMO, and
p.(None): SAW. Guarantee the physical and biological integrity of the exposed personnel and of the persons who carry out the use
p.(None): confined
p.(None): SEVENTH TITLE
p.(None): From the scientific technical committees Single Chapter
p.(None): Article 46. The scientific technical committees that may support the Secretariats regarding the
p.(None): applications for permits and authorizations, as well as regarding notices, will be made up of people with knowledge
p.(None): scientific or technological who have experience in the evaluation, control and risk management of GMOs, and
p.(None): either to human health, the environment and biological diversity or to
p.(None): 21 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): animal, plant and aquaculture health, or in modern biotechnology applied to research, creation and development of
p.(None): This type of organisms.
p.(None): The designation of the members corresponds to the Head of the Secretariat to which they provide support, or
p.(None): to the public servant in which he delegates the power.
p.(None): Article 47. The committees referred to in the previous article shall issue their rules of operation, after validation of
p.(None): the corresponding Secretariats.
p.(None): Article 48. Scientific technical committees shall conduct themselves with strict adherence to the principles of objectivity,
p.(None): impartiality and legality in the issuance of opinions and opinions that are requested, observing
p.(None): the provisions on protection of confidential information contained in the respective legal systems.
p.(None): EIGHTH TITLE
p.(None): Of the restricted areas
p.(None): Single Chapter
p.(None): Of the centers of origin and genetic diversity
p.(None): Article 49. The agreements by which the centers of origin and genetic diversity to which are determined are determined
p.(None): Article 86 of the Law refers to must contain:
p.(None): I. List of species, including scientific and common name;
p.(None): II. Taxonomic classification;
p.(None): III. The polygonal area or geographic areas in UTM coordinates, and
p.(None): IV. The necessary measures for the protection of these species.
p.(None): The agreements will be promoted interchangeably by SEMARNAT or SAGARPA, and jointly issued by
p.(None): Both Secretariats
p.(None): NINTH TITLE
p.(None): About Biosafety Information
p.(None): Chapter I
p.(None): From the National Biosafety Information System
p.(None): Article 50. The National Biosafety Information System will be in charge of the Executive Secretariat. The
p.(None): Information that integrates the System will be available on the CIBIOGEM Internet portal and must be updated
p.(None): permanently.
p.(None): Article 51. The National Biosafety Information System shall contain:
p.(None): I. Registry information in accordance with the provisions of article 56 of this
p.(None): Regulation;
p.(None): II. National statistics on biosafety and GMO;
p.(None): III. The restricted areas and the municipality or municipalities where it is located, distinguishing:
p.(None): 22 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): a) Centers of origin and genetic diversity by species; in UTM coordinates;
...

p.(None): that information on the actions implemented in compliance with the Cartagena Protocol.
p.(None): Article 54. Consultation and participation of indigenous peoples and communities settled in areas where
p.(None): The release of GMOs is intended to be carried out in accordance with the mechanisms determined for this purpose by the
p.(None): CIBIOGEM
p.(None): Chapter III Registration
p.(None): Article 55. The Registry is part of the National Biosafety Information System, will have character
p.(None): public and will be in charge of the Executive Secretariat. Its purpose is the registration of information related to
p.(None): activities with GMOs, as well as of the agencies themselves subject to the provisions of the Law and this
p.(None): Regulation.
p.(None): Article 56. The following shall be registered in the Registry:
p.(None): I. Requests for permits and authorizations;
p.(None): II. Resolutions of permits and authorizations, distinguishing which GMOs are imported; as well as resolutions to
p.(None): those referred to in article 37, section IV, of this Regulation;
p.(None): III. Suspensions and revocation;
p.(None): IV. Notices of confined use;
p.(None): V. Additional requirements and measures for the notices indicated in article 84 of the Law;
p.(None): 24 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): SAW. The communications referred to in article 59 of these Regulations, and
p.(None): VII. The others that establish the applicable provisions.
p.(None): TENTH TITLE
p.(None): From the Lists of GMOs Single Chapter
p.(None): Article 57. The lists of GMOs referred to in articles 103 and 104 of the Law shall be issued.
p.(None): by the competent Secretariats and HEALTH, through a notice that will be published in the Official Gazette of the Federation.
p.(None): The lists referred to in sections I and II of article 103 of the Law shall be published jointly.
p.(None): between SEMARNAT, SALUD and SAGARPA.
p.(None): The lists referred to in this article must be published within the first ten days
p.(None): Skills of the month of February of each year in the Official Gazette of the Federation.
p.(None): Once the lists are published, they may only be modified for any of the causes referred to in article 58 of
p.(None): this Regulation, by means of a notice that will be published in the Official Gazette of the Federation within ten days
p.(None): next to verify the cause of the respective modification.
p.(None): In the annual publication of the lists, a systemic approach that includes all GMOs that have been
p.(None): object of the above lists, in the terms established in articles 103 and 104 of the Law.
p.(None): Article 58. The causes of modification of the lists referred to in the previous article are:
p.(None): I. The resolution of an authorization or permit;
p.(None): II. Change in the legal status of the GMOs, referred to in sections I and II of the
p.(None): Article 103 of the Law, and
p.(None): III. Changes in the cases referred to in article 104, section II and last paragraph, of the Law.
p.(None): FIRST TITLE
p.(None): Inspection, surveillance, security measures or urgent application and infringements and penalties
p.(None): Single Chapter
p.(None): Article 59. In case of accidental release, permit holders or those who carry out utilization activities
p.(None): confined they must communicate this situation to the Secretariat that issued the permit or to which the notice was presented,
p.(None): within twenty-four hours after it becomes known. The secretaries
p.(None): competent will establish in the permit the means through which the permit holder must perform this
p.(None): communication, and in the formats of the notices referred to in article 72 of the Law.
p.(None): Immediately after becoming aware of the accidental release, the Secretariat that issued the permit or
p.(None): Received the notice must inform the other Secretariats about the accident and the risks or
p.(None): effects that may occur or have occurred to human health, the environment, the
p.(None): biological diversity or animal, plant or aquaculture health. These dependencies may
p.(None): 25 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): impose in its area of competence the security or urgent application measures deemed necessary for
p.(None): contend with that situation.
p.(None): In addition to the communication indicated in the first paragraph of this article, within three business days
p.(None): following the knowledge of the situation described in the previous paragraph, the permit holder or who
p.(None): carry out confined use activities must submit a written notice to the Secretariat that issued the
p.(None): permission or received permission, which will contain:
p.(None): I. Identification data of the permit or notice;
p.(None): II. The polygon where the accidental release occurred, located in UTM coordinates;
...

p.(None): ordering authority for inspection and surveillance acts, by personal notification or by mail
p.(None): certificate with acknowledgment of receipt, will require the interested party to execute, at their own expense and cost, the security measures or
p.(None): urgently applicable, indicating the deadlines for compliance.
p.(None): Article 61. When repatriation is imposed as a security measure, the interested party must cover the
p.(None): costs thereof, being able to transfer the expenses incurred against the person responsible for the infraction.
p.(None): Article 62. If, as a result of an inspection and surveillance visit, the imposition of measures of
p.(None): security or urgent application, the inspected must notify the competent Secretariat the
p.(None): compliance with each one, within a term of five business days counted from the expiration date of the term
p.(None): granted for the execution of each one of them.
p.(None): Article 63. When the competent Secretariat engages the alleged offender and he appears by
p.(None): written accepting the irregularities in the inspection record, the Secretariat will proceed, within
p.(None): Twenty following business days, to issue the respective resolution.
p.(None): Article 64. The administrative resolution issued shall indicate, in addition to the infractions and sanctions,
p.(None): the measures to be taken to correct the deficiencies or irregularities observed during
p.(None): the inspection and the period granted to comply with them, under the terms of the Law.
p.(None): TENTH SECOND
p.(None): On the Special Corn Protection Regime Single Chapter
p.(None): 26 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): Article 65. Activities related to genetically modified corn shall be subject to the present.
p.(None): Title, to the other general provisions applicable to GMOs, as well as to the provisions of other instruments that
p.(None): establish authority.
p.(None): Article amended DOF 06-03-2009
p.(None): Article 66. Individuals, when requesting permission for experimental release of genetically corn
p.(None): modified, in addition to the provisions of Article 16 of this Regulation, must provide the
p.(None): next:
p.(None): I. Reference materials that allow the detection, identification and quantification of genetically maize
p.(None): modified to be released, and
p.(None): II. The information required by the authorities to determine the origin of stages of release
p.(None): subsequent.
p.(None): Article added DOF 06-03-2009
p.(None): Article 67. Experimentation or release to the environment of genetically modified maize that
p.(None): Contains characteristics that prevent or limit its human or animal use or consumption, or its use in processing
p.(None): Food for human consumption.
p.(None): Article added DOF 06-03-2009
p.(None): Article 68. SAGARPA, prior to the granting of the experimental release permit, must verify
p.(None): that for the organism that is intended to be released there is no alternative conventional variety. If so,
p.(None): SAGARPA will carry out the comparative analysis between the different technological options. The result
...

p.(None): TENTH. All provisions that oppose this Regulation are repealed.
p.(None): Given at the Residence of the Federal Executive Power, in Mexico City, Federal District, on the fourteenth day of the
p.(None): March of two thousand eight.- Felipe de Jesús Calderón Hinojosa.- Rubric.- The Secretary of the Middle
p.(None): Environment and Natural Resources, Juan Rafael Elvira Quesada.- Heading.- The Secretary of Economy, Eduardo
p.(None): Sojo Garza Aldape.- Heading.- The Secretary of Agriculture, Livestock, Rural Development, Fisheries and
p.(None): Food, Alberto Cárdenas Jiménez.- Heading.- The Secretary of Public Education, Josefina Eugenia Vázquez Mota.-
p.(None): Rubric.- The Secretary of Health, José Ángel Córdova Villalobos.- Rubric.
p.(None): 29 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): TRANSITIONAL ARTICLES OF REFORM DECREES
p.(None): DECREE whereby various provisions of the Regulations of the Law on the Reform are amended, added and repealed
p.(None): Biosecurity of Genetically Modified Organisms.
p.(None): Published in the Official Gazette of the Federation on March 6, 2009
p.(None): FIRST ARTICLE.- Article 65 is REFORMED and Articles 66, 67, 68, 69, 70, 71, 72 and 73 of the
p.(None): Regulation of the Biosafety Law of Genetically Modified Organisms, to read as follows:
p.(None): ………
p.(None): SECOND ARTICLE.- The fifth transitory article is REFORMED and the eighth transitory article of the Regulation is REPEALED
p.(None): of the Biosafety Law of Genetically Modified Organisms, to read as follows:
p.(None): ………
p.(None): TRANSITORY
p.(None): SINGLE.- This Decree shall enter into force on the day following its publication in the Official Gazette of the
p.(None): Federation.
p.(None): Given at the Residence of the Federal Executive Power, in Mexico City, Federal District, on March 5, two
p.(None): Nineteen.- Felipe de Jesús Calderón Hinojosa.- Heading.- The Secretary of Environment and Resources
p.(None): Naturales, Juan Rafael Elvira Quesada.- Heading.- The Secretary of Economy, Gerardo Ruiz Mateos.-
p.(None): Heading.- The Secretary of Agriculture, Livestock, Rural Development, Fisheries and Food, Alberto Cárdenas
p.(None): Jiménez.- Rubric.- The Secretary of Public Education, Josefina Eugenia Vázquez Mota.- Rubric.- The Secretary
p.(None): of Health, José Ángel Córdova Villalobos.- Rubric.
...

Searching for indicator property:

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p.(None): Applicable legislation in force in the export country translated into Spanish.
p.(None): SAW. Considerations on the risks of technological alternatives available to contend
p.(None): with the problem for which the GMO was built, in case such alternatives exist;
p.(None): VII. Authorization number issued by HEALTH when the GMO has public health purposes or is destined for
p.(None): bioremediation In case of not having the authorization at the time of
p.(None): 8 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): submit the permit application, the promoter may subsequently submit it attached to a free letter,
p.(None): in which the authorization number is indicated;
p.(None): VIII. The validity proposal for the permit and the elements used to determine it, and
p.(None): IX. The information determined in each case by the NOM.
p.(None): Article 17. The information to be attached to the application for permission to release GMOs into the environment in
p.(None): Pilot program in accordance with Articles 5, 6 and 7 of this Regulation, shall be the following:
p.(None): I. Identification data of the experimental release permit or simple copy of said permit;
p.(None): II. Reference and considerations on the report of the results of the release (s)
p.(None): carried out in relation to possible risks to the environment and biological diversity and,
p.(None): additionally, to animal, plant or aquaculture health;
p.(None): III. GMO amount to be released;
p.(None): IV. Driving conditions that will be given to the GMO;
p.(None): V. Identification of the zone or zones where the GMO is intended to be released:
p.(None): a) Total area of the property or land where the release will take place;
p.(None): b) Location, in UTM coordinates, of the polygon or polygons where the release will take place, and
p.(None): c) Description of the polygons where the release will be carried out and of the areas surrounding them within a radius according to the
p.(None): Dissemination characteristics of the GMO in question:
p.(None): 1. List of sexually compatible species and species that interact in the area of release and in
p.(None): neighboring areas in the radius indicated in this subsection;
p.(None): 2. Geographic description, and
p.(None): 3. Location map indicating the main communication routes.
p.(None): SAW. Monitoring and biosecurity measures to be carried out:
p.(None): a) Monitoring measures:
p.(None): 1. Detailed monitoring plan;
p.(None): 2. Post-GMO monitoring strategies, in order to detect any
p.(None): interaction between the GMO and species present in the area of the area or areas where the release is intended,
p.(None): when they exist, and
p.(None): 3. Strategies for the detection of GMOs and their subsequent presence in the area or areas where it is intended to carry out the
p.(None): liberation and neighboring areas, once the liberation is concluded.
p.(None): b) Biosafety measures:
p.(None): 9 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): 1. Measures for the eradication of GMOs in areas other than those allowed, and
p.(None): 2. Measures for the protection of human health and the environment, should a release event not occur
p.(None): wanted.
...

Searching for indicator conviction:

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p.(None): the one in which the request for reconsideration was delivered, to deliver its opinion or opinion to the Secretariat
p.(None): competent who resolved the permit application.
p.(None): Article 36. The Secretariat that negatively resolved the request for permission or authorization shall
p.(None): resolve the request for reconsideration within a period not exceeding two months, counted from the business day following
p.(None): that the promoter has submitted his request for reconsideration.
p.(None): Chapter II
p.(None): On the review of permits and authorizations
p.(None): 19 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): Article 37. The competent Secretariats and HEALTH may review the permits and authorizations granted in
p.(None): the scope of their respective competence, when any of the cases established in the articles are presented
p.(None): 69 and 98 of the Law.
p.(None): The review of permits and authorizations granted by the Secretariats will be carried out in accordance with the following
p.(None): process:
p.(None): I. The reviewing Secretariat shall notify the holder of the permit or authorization of the beginning of the
p.(None): review, and must establish and motivate the causes that gave rise to the procedure;
p.(None): II. The holder of the permit or authorization will have fifteen business days to state what is in their right
p.(None): agree and present any element of conviction that has the character of evidence;
p.(None): III. Once the statements and evidence of the holder of the permit or authorization have been received, or without them, the
p.(None): Reviewing Secretariat will initiate the evaluation process and will confront the information, in order to issue the
p.(None): corresponding resolution;
p.(None): IV. The resolution that falls to the revision of the permit or authorization may:
p.(None): a) Maintain it in the terms in which it was granted;
p.(None): b) Modify the conditions under which it was granted;
p.(None): c) Suspend its effects, or
p.(None): d) Revoke it, and
p.(None): V. The reviewing Secretariat will have thirty business days to issue the respective resolution,
p.(None): which must be made known to the other Secretariats and to the holder of the permit or authorization object of
p.(None): the revision, except in the case of subsection a) of section IV of this article, in which case it is only due
p.(None): notify the holder of the permit or authorization.
p.(None): Article 38. When the permit has been granted by SAGARPA, and SEMARNAT has new scientific information
p.(None): or technique that allows establishing possible risks to the environment and biological diversity, this dependence
p.(None): It will inform SAGARPA so that it may initiate the review procedure referred to in the
p.(None): previous article.
p.(None): Article 39.- During the evaluation process referred to in section III of article 37 of the
p.(None): this Regulation, SEMARNAT will review its opinion, based on the new scientific or technical information and, if
p.(None): necessary, will modify it. The opinion issued by SEMARNAT will be binding for the resolution of the procedure of
p.(None): SAGARPA review.
...

Searching for indicator education:

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p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
p.(None): General Secretary
p.(None): Secretariat of Parliamentary Services
p.(None): Last DOF Reform 06-03-2009
p.(None): VII. GMO data including the scientific, common and commercial name, and
p.(None): VIII. The means through which the communication referred to in article 59 of this
p.(None): Regulation.
p.(None): IX. Registration of accredited persons, if you have it. In this case, you should not present the
p.(None): information referred to in fractions I to IV.
p.(None): The notice must be presented in the cases established in articles 79 and 80 of the Law.
p.(None): SEVENTH. The actions derived from this Regulation will be executed under the budget approved for the
p.(None): Dependencies and Entities responsible for its application.
p.(None): EIGHTH. Repealed
p.(None): Article repealed DOF 06-03-2009
p.(None): NINETH. The members of the CIBIOGEM will establish, within the year following the entry into force of this
p.(None): Regulation, public policies for the protection, use, development and sustainable use of species of
p.(None): which Mexico is a center of origin and genetic diversity.
p.(None): TENTH. All provisions that oppose this Regulation are repealed.
p.(None): Given at the Residence of the Federal Executive Power, in Mexico City, Federal District, on the fourteenth day of the
p.(None): March of two thousand eight.- Felipe de Jesús Calderón Hinojosa.- Rubric.- The Secretary of the Middle
p.(None): Environment and Natural Resources, Juan Rafael Elvira Quesada.- Heading.- The Secretary of Economy, Eduardo
p.(None): Sojo Garza Aldape.- Heading.- The Secretary of Agriculture, Livestock, Rural Development, Fisheries and
p.(None): Food, Alberto Cárdenas Jiménez.- Heading.- The Secretary of Public Education, Josefina Eugenia Vázquez Mota.-
p.(None): Rubric.- The Secretary of Health, José Ángel Córdova Villalobos.- Rubric.
p.(None): 29 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): TRANSITIONAL ARTICLES OF REFORM DECREES
p.(None): DECREE whereby various provisions of the Regulations of the Law on the Reform are amended, added and repealed
p.(None): Biosecurity of Genetically Modified Organisms.
p.(None): Published in the Official Gazette of the Federation on March 6, 2009
p.(None): FIRST ARTICLE.- Article 65 is REFORMED and Articles 66, 67, 68, 69, 70, 71, 72 and 73 of the
p.(None): Regulation of the Biosafety Law of Genetically Modified Organisms, to read as follows:
p.(None): ………
p.(None): SECOND ARTICLE.- The fifth transitory article is REFORMED and the eighth transitory article of the Regulation is REPEALED
p.(None): of the Biosafety Law of Genetically Modified Organisms, to read as follows:
p.(None): ………
p.(None): TRANSITORY
p.(None): SINGLE.- This Decree shall enter into force on the day following its publication in the Official Gazette of the
p.(None): Federation.
p.(None): Given at the Residence of the Federal Executive Power, in Mexico City, Federal District, on March 5, two
p.(None): Nineteen.- Felipe de Jesús Calderón Hinojosa.- Heading.- The Secretary of Environment and Resources
p.(None): Naturales, Juan Rafael Elvira Quesada.- Heading.- The Secretary of Economy, Gerardo Ruiz Mateos.-
p.(None): Heading.- The Secretary of Agriculture, Livestock, Rural Development, Fisheries and Food, Alberto Cárdenas
p.(None): Jiménez.- Rubric.- The Secretary of Public Education, Josefina Eugenia Vázquez Mota.- Rubric.- The Secretary
p.(None): of Health, José Ángel Córdova Villalobos.- Rubric.
...

Searching for indicator gender:

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p.(None): Chapter II
p.(None): Requirements and resolution of requests for authorizations
p.(None): Article 31. The information to be attached to the authorization request of the GMO, in accordance
p.(None): with articles 23 and 24 of this Regulation, it will be the following:
p.(None): I. Study of possible risks that the human use or consumption of the GMO in question could
p.(None): represent human health, which will include scientific and technical information related to their safety,
p.(None): consisting of:
p.(None): a) Receiving organism, be it plant, animal or microorganism:
p.(None): 1. Identification;
p.(None): 2. Most recent taxonomic designation;
p.(None): 3. Origin, history of safe use in food, previous experiences of use or consumption;
p.(None): 4. Pathogenicity associated with genera and species, any relevant evidence of the potential for
p.(None): production of toxic or antinutrient compounds, and
p.(None): 5. Indication of the presence of plasmids, transposons and integrons containing resistance genes to
p.(None): antimicrobials
p.(None): b) About each gene donor organism:
p.(None): 1. Most recent taxonomic classification;
p.(None): 2. History of use;
p.(None): 3. Origin, and
p.(None): 14 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): 4. Indication of the presence of plasmids, transposons and integrons containing resistance genes to
p.(None): antimicrobials
p.(None): c) In the case of genetically modified microorganisms, whether they are gene receptors or donors:
p.(None): 1. Gender, species, subspecies, strain and common name of the recipient;
p.(None): 2. Genetic stability, potential immunological impact and human health, ability to form spores or other
p.(None): survival structures, and
p.(None): 3. Infectivity, virulence factors and range of receptors potentially susceptible to being infected.
p.(None): d) About the introduction of genetic material:
p.(None): 1. Function of the introduced DNA;
p.(None): 2. Location and orientation of genetic material;
p.(None): 3. For all introduced DNA, the DNA sequence or restriction map must be described,
p.(None): characterization of all genetic components including marker genes, regulatory elements,
p.(None): promoters, terminators and others that affect DNA function;
p.(None): 4. Detailed description of the transformation method and number of coding sequences;
p.(None): 5. Regulation of gene expression, identification of any open reading frame within DNA
p.(None): inserted or created by modifications of the adjacent DNA on the chromosome;
p.(None): 6. Stability of the modification, and
p.(None): 7. Intermediary host organizations.
p.(None): e) When a marker gene was used as a selection element for modified organisms:
p.(None): 1. Reasons for choosing said marker, and
p.(None): 2. If it is a gene that confers antimicrobial resistance, its use must be justified and the
p.(None): no choice of another marker gene.
p.(None): f) Regarding the GMO:
p.(None): 1. Organization of the inserted genetic material and the methods used for its characterization;
p.(None): 2. In the event that truncated portions have been inserted, their size should be established.
p.(None): action of the expression product of the inserted genes;
p.(None): 15 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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
...

Searching for indicator parents:

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p.(None): specific food or components that were altered as a result of the genetic modification, and
p.(None): 5. When used for the bioassay, a transgenic protein obtained from bacterial cultures,
p.(None): It must be demonstrated that the protein expressed in the GMO has the same molecular weight and immunoreactivity as the protein
p.(None): microbial
p.(None): m) Complete allergenicity studies. The relevant criteria used should include aspects
p.(None): referring to:
p.(None): 17 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): 1. Origin of the transferred genetic material;
p.(None): 2. Homology of amino acid sequences between the new protein and known allergens;
p.(None): 3. Effect of pH or enzymatic digestion;
p.(None): 4. Stability against heat or processing;
p.(None): 5. Post-transduction modifications, and
p.(None): 6. When, although there is no homology between the transgenic protein and known allergens, but the evidence
p.(None): cited enzymatic digestion, at pH and heat stability or processing, demonstrate their allergenic potential,
p.(None): should provide data from the IgE cross-reactivity analysis between a new expression protein and
p.(None): a known allergen;
p.(None): n) In the case of events with a combination of genes, the parental events involved in the generation of said
p.(None): event must be previously authorized. The information to be delivered in this particular type of GMOs
p.(None): It includes:
p.(None): 1. Specification of the following categories:
p.(None): i. Category 1. Parentals with unrelated phenotypic characteristics;
p.(None): ii. Category 2. Parents who have related characteristics but their action derives from routes
p.(None): different or included in different modes of action, and
p.(None): iii Category 3. Parents with characteristics related to activity on the same metabolic pathway or
p.(None): biosynthetic
p.(None): 2. Procedure applied to obtain the event with a combination of genes, including
p.(None): Genotypic and phenotypic characteristics of their parental lines:
p.(None): i. Metabolic pathways in which each of the transgenic proteins encoded in the event act
p.(None): with combination of genes;
p.(None): ii. Studies on the stability of inserted genes, and
p.(None): iii. Substantial equivalence studies, and
p.(None): II. In case of authorization requests from a GMO to be able to import them for the purposes for which
p.(None): Article 91 of the Law refers to the information and documentation proving that the GMO is authorized
p.(None): according to the legislation of the country of origin or, failing that, the interested party's declaration of non-existence
p.(None): of said situation and exposure of the elements of consideration that support the one that HEALTH can resolve the
p.(None): authorization request, and
p.(None): III. The other requirements determined by HEALTH in the NOMs derived from the Law.
p.(None): Article 32. HEALTH will decide on the request for authorization within a period not exceeding six months from
p.(None): the business day following the one that admits the request.
p.(None): It is understood that the request is admitted in cases where the request was received and the information is complete,
p.(None): in accordance with the provisions of article 30, second paragraph, of these Regulations.
p.(None): 18 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): FOURTH TITLE
...

Searching for indicator opinion:

(return to top)
p.(None): For the purposes of the provisions of article 44 of the Law, it is understood that the integrated application was
p.(None): received and the information is complete, in cases where once submitted it is not done prevention or done it is
p.(None): attended by the promoter, without prejudice to the powers conferred by article 34, section II of the Law a
p.(None): the competent Secretariat.
p.(None): Article 9.- If the competent Secretariat does not carry out the prevention in the terms indicated in the
p.(None): previous article may not dismiss the process arguing that it is incomplete.
p.(None): Article 10. The competent Secretariat may only require additional information, within twenty days
p.(None): to the admission of the integrated application, in the cases referred to in article 63 of the Law.
p.(None): Article 11. The promoter will have a term of twenty working days, counted from the day
p.(None): after the notification has taken effect, to meet the requirement referred to in the
p.(None): Article 10 of this Regulation.
p.(None): After this period has elapsed without the requestor having submitted the requested information, the competent Secretariat may
p.(None): deny permission, in accordance with the provisions of section II of article 34 of the Law.
p.(None): During the twenty-day period and the one planned to address the prevention referred to in article 8 of this
p.(None): ordination, the periods of resolution of the permit of the application or of the emission will be suspended
p.(None): 3 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): of the opinion or opinion, and will resume the next business day after the promoter relieves the
p.(None): request.
p.(None): Article 12. Within two business days after the integrated application is admitted, the Secretariat
p.(None): competent will send to the Registry a copy of it for their respective registration and publicity, in terms of
p.(None): Article 33 of the Law.
p.(None): Article 13. For the purpose of issuing the opinion or opinion referred to in article 34 of the Law,
p.(None): proceed as follows:
p.(None): I. Within three business days following that in which the integrated permit application was admitted, the
p.(None): The competent Secretariat must deliver a copy of it to the Secretariat that must issue the opinion or opinion;
p.(None): II. When additional information is required, in the cases referred to in article 63 of the Law, for the
p.(None): Issuance of opinion or opinion, the Secretariat that must issue this opinion or opinion shall communicate it in writing and by
p.(None): only once to the competent Secretariat, for which the provisions of articles 10 and 11 of this
p.(None): Regulation.
p.(None): The deadline for carrying out this review and communicating in writing the result thereof to the Secretariat
p.(None): competent, it will be ten business days from the day after receiving the copy of the application
p.(None): of permission, and
p.(None): III. In case the Secretariat that must issue the opinion or opinion does not request the additional information,
p.(None): you must issue your opinion or opinion with the information on the copy of the integrated application to which
p.(None): refers to section I of this article, without being able to argue the lack of such information to issue an opinion
p.(None): or opinion in the negative sense.
p.(None): Article 14. The Secretariat that must issue the opinion or opinion, regarding the permits of
p.(None): release, including its importation, referred to in article 32 of the Law, will have the deadlines
p.(None): following to deliver to the competent Secretariat:
p.(None): I. In the case of experimental release to the environment, up to eighty business days;
p.(None): II. In the case of release to the environment in a pilot program, up to forty business days, and
p.(None): III. In the case of commercial release to the environment up to fifty business days.
p.(None): The deadlines referred to in this article will be counted from the day following that in which the
p.(None): Secretariat that must issue the opinion or opinion, receive the copy of the integrated application from the
p.(None): Competent Secretariat
p.(None): In case the Secretariat that must issue the opinion or opinion does not deliver it within the deadlines
p.(None): provided in this article, it will be understood that there is no objection to the claims of the promoter.
p.(None): Article 15. The opinion or opinion referred to in the previous article must contain:
p.(None): I. Statement by the Secretariat issuing the opinion or opinion, favorable or unfavorable on the request
p.(None): integrated permit;
p.(None): II. When favorable, the following will be indicated:
p.(None): 4 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): a) Opinion regarding the proposed validity of the permit and, if necessary, the measures and procedures of
p.(None): monitoring and biosafety additional to those presented by the promoter;
p.(None): b) The reasons why it is determined to add such measures and procedures, and
p.(None): c) The legal provisions on which the additions mentioned in subparagraph a) of this section are based, and the
p.(None): scientific reasons that justify establishing additional measures and procedures.
p.(None): III. When unfavorable, the following will be indicated:
p.(None): a) If this is the case, the reasons why it is considered that the promoter did not address the issues
p.(None): raised in the requirement referred to in article 10 of the Regulation;
p.(None): b) The scientific or technical reasons why it is considered that the risks that could present
p.(None): The GMOs in question will adversely affect biological diversity, the environment, health
p.(None): animal, vegetable or aquaculture, and may cause serious or irreversible damage;
p.(None): c) The reasons why the requested release contravenes the Law, this Regulation and the rest
p.(None): applicable provisions, and
p.(None): d) Other determinations made by the authority in exercise of the precautionary approach established in
p.(None): the law.
p.(None): In accordance with the last paragraph of article 15 of the Law, the biosafety opinion referred to in the
p.(None): Section I of said article shall be binding on SAGARPA in the resolution of the permit applications that
p.(None): in accordance with the Law are within its competence.
p.(None): Chapter II
p.(None): Requirements for release permits to the environment
p.(None): Article 16. The information to be attached to the request for experimental release of GMOs from
p.(None): In accordance with Articles 5, 6 and 7 of this Regulation, it will be as follows:
p.(None): I. Characterization of the GMO;
p.(None): a) Unique identifier of the transformation event, of international organizations of which Mexico is a part,
p.(None): when it exists;
p.(None): b) Species related to the GMO and their distribution in Mexico;
p.(None): c) Specification of the existence of sexually compatible species;
p.(None): d) Description of habitats where GMO can persist or proliferate in the release environment;
p.(None): e) Taxonomic description of the recipient and donor organism of the genetic construction;
p.(None): f) Country and location where the GMO was collected, developed or produced;
p.(None): 5 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): g) Documentary reference on origin and diversification of the receiving agency;
p.(None): h) Detailed gene sequence of the transformation event, including size of the inserted fragment, site of
p.(None): insertion of the genetic construct, including the sequences of the oligonucleotides that allow the
p.(None): insertion site amplification;
p.(None): i) Description of the flanking sequences, number of copies inserted, and the results of the experiments
...

p.(None): the permit was issued the results of the releases made at the time established in the permits
p.(None): corresponding. The report will contain the following:
p.(None): I. Guidelines of the proposed protocol for experimental or pilot program release;
p.(None): II. Phenotypic changes of the GMO regarding its adaptation to the release area;
p.(None): III. Effects of selection genes and possible effects on biodiversity;
p.(None): IV. Biochemical and metabolic characterization of all the products of the novel gene in relation to its activity,
p.(None): degradation products or by-products, secondary products and metabolic pathways;
p.(None): V. Changes in the competitive capacity of the GMO compared to the unmodified counterpart, including
p.(None): survival and reproduction, production of reproductive structures, latency periods and cycle duration of
p.(None): lifetime;
p.(None): SAW. Possible effects on the environment and biological diversity due to the release of the GMO, including the protocol
p.(None): used to establish these possible effects;
p.(None): VII. Effects of use and exploitation practices, and
p.(None): VIII. Where appropriate, bibliographic reference on the data presented.
p.(None): In the permits the competent Secretariat may establish, on a case-by-case basis, specific content requirements of
p.(None): Results reports. In the case of releases of GMOs that are the responsibility of the
p.(None): 10 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): SAGARPA, said Secretariat will consider what is established in the binding opinion issued by SEMARNAT
p.(None): in accordance with the Law and this Regulation.
p.(None): Article 19. The information to be attached to the request for a commercial release permit to the environment of
p.(None): GMOs, in accordance with articles 5, 6 and 7 of this Regulation, shall be the following:
p.(None): I. Identification data of the experimental release permit and release permit in
p.(None): pilot program, or simple copy of each of the aforementioned permits;
p.(None): II. Description of the area where the release will take place, which will consist of the following:
p.(None): a) Location, in UTM coordinates, of the polygon or polygons where you can make the release;
p.(None): b) Municipality or municipalities where each of these polygons is located, and
p.(None): c) State or states where each of these polygons is located.
p.(None): III. Reference and considerations on the results of experimental release and release results
p.(None): in a pilot program that has been carried out, in terms of the permits referred to in the previous section;
p.(None): IV. Specific transport instructions or recommendations, in accordance with the NOMs referred to in the
p.(None): Article 76 of the Law, of storage and, where appropriate, management;
p.(None): V. Conditions for release and commercialization, if necessary;
p.(None): SAW. Considerations on the risks of technological alternatives available to contend
p.(None): with the problem for which the GMO was built, in case such alternatives exist;
p.(None): VII. Where appropriate, the information available to the applicant on data or results of the
p.(None): marketing of the same GMO in other countries;
p.(None): VIII. In case of import of the GMO, legalized or apostilled copy of the authorizations or documentation
p.(None): official proving that the GMO is allowed according to the legislation of the country of origin, at least for its
...

p.(None): Last DOF Reform 06-03-2009
p.(None): FOURTH TITLE
p.(None): On the reconsideration of negative resolutions and the review of permits and authorizations
p.(None): Chapter I
p.(None): On the reconsideration of negative resolutions
p.(None): Article 33. For the case established in articles 67 and 98 of the Law, the request for
p.(None): reconsideration of a negative resolution on a permit or authorization must be presented
p.(None): before the authority that issued it, and must provide the elements on which the claim of the
p.(None): promoter in the same reconsideration brief.
p.(None): In the notice of reconsideration, the promoter must indicate:
p.(None): I. The identification data of the resolution and the date it was issued and
p.(None): II. The arguments and elements that demonstrate that your request adheres to the assumptions provided for in article 67
p.(None): of the law.
p.(None): Article 34. In cases where the release of GMOs to the environment has been denied, because HEALTH
p.(None): did not grant the corresponding authorization, the promoter may present simultaneously to the Secretariat
p.(None): competent and HEALTH, the request for reconsideration. However for the competent Secretariat that denied permission
p.(None): Resolve the request for reconsideration, the one submitted to HEALTH must be resolved.
p.(None): Within three business days after the corresponding reconsideration has been resolved, HEALTH will send a
p.(None): copy of its resolution to the competent Secretariat that resolved in a negative sense the request for permission or
p.(None): the authorization, so that the latter resolves the reconsideration within five business days
p.(None): following.
p.(None): Article 35. In case the request for permission had been denied based on the opinion of the SEMARNAT or in the
p.(None): opinion of SAGARPA, the competent Secretariat that resolved the permit application must deliver the
p.(None): request for reconsideration to the Secretariat that must rule or give an opinion, within a period not exceeding three business days,
p.(None): counted from when the individual has entered his reconsideration request.
p.(None): Likewise, the request for reconsideration will be sent to the Secretariat that must decide or give an opinion, when
p.(None): of the new information presented in the reconsideration, derive issues that should be known to the
p.(None): Secretariat issuing the opinion or opinion.
p.(None): The Secretariat that must rule or give an opinion shall have a term not exceeding one month, counted from the day following
p.(None): the one in which the request for reconsideration was delivered, to deliver its opinion or opinion to the Secretariat
p.(None): competent who resolved the permit application.
p.(None): Article 36. The Secretariat that negatively resolved the request for permission or authorization shall
p.(None): resolve the request for reconsideration within a period not exceeding two months, counted from the business day following
p.(None): that the promoter has submitted his request for reconsideration.
p.(None): Chapter II
p.(None): On the review of permits and authorizations
p.(None): 19 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): Article 37. The competent Secretariats and HEALTH may review the permits and authorizations granted in
p.(None): the scope of their respective competence, when any of the cases established in the articles are presented
p.(None): 69 and 98 of the Law.
p.(None): The review of permits and authorizations granted by the Secretariats will be carried out in accordance with the following
p.(None): process:
p.(None): I. The reviewing Secretariat shall notify the holder of the permit or authorization of the beginning of the
p.(None): review, and must establish and motivate the causes that gave rise to the procedure;
p.(None): II. The holder of the permit or authorization will have fifteen business days to state what is in their right
p.(None): agree and present any element of conviction that has the character of evidence;
p.(None): III. Once the statements and evidence of the holder of the permit or authorization have been received, or without them, the
p.(None): Reviewing Secretariat will initiate the evaluation process and will confront the information, in order to issue the
p.(None): corresponding resolution;
p.(None): IV. The resolution that falls to the revision of the permit or authorization may:
p.(None): a) Maintain it in the terms in which it was granted;
p.(None): b) Modify the conditions under which it was granted;
p.(None): c) Suspend its effects, or
p.(None): d) Revoke it, and
p.(None): V. The reviewing Secretariat will have thirty business days to issue the respective resolution,
p.(None): which must be made known to the other Secretariats and to the holder of the permit or authorization object of
p.(None): the revision, except in the case of subsection a) of section IV of this article, in which case it is only due
p.(None): notify the holder of the permit or authorization.
p.(None): Article 38. When the permit has been granted by SAGARPA, and SEMARNAT has new scientific information
p.(None): or technique that allows establishing possible risks to the environment and biological diversity, this dependence
p.(None): It will inform SAGARPA so that it may initiate the review procedure referred to in the
p.(None): previous article.
p.(None): Article 39.- During the evaluation process referred to in section III of article 37 of the
p.(None): this Regulation, SEMARNAT will review its opinion, based on the new scientific or technical information and, if
p.(None): necessary, will modify it. The opinion issued by SEMARNAT will be binding for the resolution of the procedure of
p.(None): SAGARPA review.
p.(None): Article 40. The review of permits and authorizations practiced by the relevant Secretariats and HEALTH in their
p.(None): respective fields of competence and in the terms of the Law and these Regulations, will be carried out independently
p.(None): of security measures or urgent application that could be determined by the Secretariats themselves according to
p.(None): to article 115 of the Law.
p.(None): FIFTH TITLE
p.(None): On the import and export of GMOs that are destined to be released into the environment Single Chapter
p.(None): 20 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): Article 41. Prior to the importation of GMOs that are intended to be released into the environment, the
p.(None): permission corresponding to the corresponding release, which will have the effect of import permit in the
p.(None): terms established by law.
p.(None): Article 42. The notification referred to in article 72 of the Law must be made in writing,
p.(None): complying with the requirements established in the international treaties and agreements to which Mexico is a party, as well
p.(None): as required by the authorities of the country of destination of the GMOs.
p.(None): SIXTH TITLE
p.(None): Of the internal biosafety commissions Single Chapter
p.(None): Article 43. The internal biosafety commissions referred to in article 74, section III, of
p.(None): the Law, will be integrated by a minimum of three people who have experience and knowledge in the activities
p.(None): of confined use of GMOs.
p.(None): Article 44.- The internal biosecurity commissions will be permanent and their members may be replaced by
p.(None): in accordance with the internal rules that are issued for its operation and that must be approved by the instance
p.(None): empowered of those who carry out activities of confined use of GMOs.
p.(None): Article 45. Internal biosafety commissions shall:
p.(None): I. Issue biosafety rules, which must contain, among other aspects, the prevention
p.(None): of accidental releases and monitoring of compliance with the rules and good practices;
p.(None): II. Define the good practices of scientific research that must be observed;
p.(None): III. Provide scientific and technical advice to those responsible for utilization activities
p.(None): confined to the GMO, within the scope of its material competence;
p.(None): IV. Issue technical opinion on the biosafety aspects of teaching and research
p.(None): proposals, prior review of the facilities and materials to be used for the safe handling of the
p.(None): GMOs and methods involved;
p.(None): V. Ensure the security of the facilities in which the activities of confined use are carried out, as well
p.(None): such as safety in the management of the GMO, and
p.(None): SAW. Guarantee the physical and biological integrity of the exposed personnel and of the persons who carry out the use
p.(None): confined
p.(None): SEVENTH TITLE
p.(None): From the scientific technical committees Single Chapter
p.(None): Article 46. The scientific technical committees that may support the Secretariats regarding the
p.(None): applications for permits and authorizations, as well as regarding notices, will be made up of people with knowledge
p.(None): scientific or technological who have experience in the evaluation, control and risk management of GMOs, and
p.(None): either to human health, the environment and biological diversity or to
p.(None): 21 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): animal, plant and aquaculture health, or in modern biotechnology applied to research, creation and development of
p.(None): This type of organisms.
p.(None): The designation of the members corresponds to the Head of the Secretariat to which they provide support, or
p.(None): to the public servant in which he delegates the power.
p.(None): Article 47. The committees referred to in the previous article shall issue their rules of operation, after validation of
p.(None): the corresponding Secretariats.
...

p.(None): II. The competent Secretariat that has promoted the Agreement for the determination of a center of origin and of
p.(None): genetic diversity, for the purposes of the information provided for in section III, subsection a), of the previous article, and
p.(None): you must do so within five business days after the Agreements have been published;
p.(None): III. The SEMARNAT, for the purposes of the information provided for in section III, subsection b), of the preceding article, and
p.(None): you must do it within five business days after a natural protected area of character has been created
p.(None): federal;
p.(None): IV. SAGARPA, for the purposes of the information referring to subsection d) of section III of the previous article,
p.(None): within five business days after a GMO-free zone has been created;
p.(None): 23 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): V. The dependencies and entities of the federal public administration and the institutes of
p.(None): national research and people who develop biotechnology, who generate relevant documents on
p.(None): biotechnology,
p.(None): SAW. The competent Secretariat that admits a permit application, for the purposes of section VI of the article
p.(None): previous, and
p.(None): VII. The competent Secretariat that receives a communication in terms of Article 59 of these Regulations,
p.(None): within five business days after the measures to be taken by the competent Secretariat have been decided.
p.(None): For the purposes of section II of the preceding article, the Executive Secretary shall request the Secretariats and the
p.(None): CIBIOGEM consultation and opinion bodies the necessary information to integrate statistics.
p.(None): The Secretariats and the consultation and opinion bodies of the CIBIOGEM must respond to these requests
p.(None): entering in the information system referred to in this article, the data and documents required by the
p.(None): Executive Secretary.
p.(None): Chapter II
p.(None): From monitoring to biosafety information
p.(None): Article 53. The CIBIOGEM will prepare and publish in its Internet portal an annual report of the
p.(None): general situation in the country regarding biosafety, considering at least the statistics derived from
p.(None): the information included in the Registry on applications, permits, authorizations and notices, as well as
p.(None): that information on the actions implemented in compliance with the Cartagena Protocol.
p.(None): Article 54. Consultation and participation of indigenous peoples and communities settled in areas where
p.(None): The release of GMOs is intended to be carried out in accordance with the mechanisms determined for this purpose by the
p.(None): CIBIOGEM
p.(None): Chapter III Registration
p.(None): Article 55. The Registry is part of the National Biosafety Information System, will have character
p.(None): public and will be in charge of the Executive Secretariat. Its purpose is the registration of information related to
p.(None): activities with GMOs, as well as of the agencies themselves subject to the provisions of the Law and this
p.(None): Regulation.
p.(None): Article 56. The following shall be registered in the Registry:
p.(None): I. Requests for permits and authorizations;
p.(None): II. Resolutions of permits and authorizations, distinguishing which GMOs are imported; as well as resolutions to
p.(None): those referred to in article 37, section IV, of this Regulation;
p.(None): III. Suspensions and revocation;
p.(None): IV. Notices of confined use;
p.(None): V. Additional requirements and measures for the notices indicated in article 84 of the Law;
...

General/Other / Other Country

Searching for indicator another country:

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p.(None): b) Biosecurity measures and procedures:
p.(None): 1. Measures and procedures to prevent the release and dispersion of GMOs outside the area or areas where
p.(None): it tries to realize the liberation;
p.(None): 7 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): 2. Measures and procedures to reduce the access of dispersion vector organisms, or of
p.(None): persons who are not authorized to enter the area of liberation to said zone or zones;
p.(None): 3. Measures for the eradication of GMOs in areas other than those allowed;
p.(None): 4. Measures for the isolation of the area where the GMO is intended to be released experimentally;
p.(None): 5. Measures for the protection of human health and the environment, should a release event not occur
p.(None): desired, and
p.(None): 6. Methods for cleaning or final disposal of waste from release.
p.(None): The promoter must clearly distinguish the measures and procedures that will be carried out during the
p.(None): release of those that will be made after it.
p.(None): V. Background of release of the GMO in other countries, when this has been done, and must attach the information
p.(None): relevant when it is within reach of the promoter:
p.(None): a) Description of the area where the release was made;
p.(None): b) Effects of release on flora and fauna;
p.(None): c) Study of the possible risks of the release of GMOs presented in the country of origin, when it has been
p.(None): required by the authority of another country and have access to it. The description of the measures and
p.(None): established biosecurity monitoring procedures should be included in the study.
p.(None): d) In case the promoter considers it appropriate, other studies or considerations in which both are analyzed
p.(None): the contribution of the GMO to the solution of environmental, social, productive or other problems, as well as the
p.(None): socioeconomic considerations that exist regarding the release of GMOs to the environment. These analyzes
p.(None): they must be based on scientific and technical evidence, on the background on use, production and consumption,
p.(None): and may be considered by the relevant Secretariats as additional elements to decide on the
p.(None): experimental release to the environment, and consequent releases to the environment in pilot and commercial program,
p.(None): respectively, of the GMO in question, and
p.(None): e) In case of import, legalized or apostilled copy of the authorizations or official documentation proving
p.(None): that the GMO is allowed under the legislation of the country of origin, at least for experimental release,
p.(None): Translated into Spanish. The competent Secretariat, if deemed necessary, may require a simple copy of the
p.(None): Applicable legislation in force in the export country translated into Spanish.
p.(None): SAW. Considerations on the risks of technological alternatives available to contend
p.(None): with the problem for which the GMO was built, in case such alternatives exist;
p.(None): VII. Authorization number issued by HEALTH when the GMO has public health purposes or is destined for
p.(None): bioremediation In case of not having the authorization at the time of
p.(None): 8 of 30
p.(None): REGULATION OF THE BIOSEGURITY LAW OF GENETICALLY MODIFIED ORGANISMS
p.(None): CHAMBER OF DEPUTIES OF THE H. CONGRESS OF THE UNION
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.(None): I. Statement by the Secretariat issuing the opinion or opinion, favorable or unfavorable on the request
p.(None): integrated permit;
p.(None): II. When favorable, the following will be indicated:
p.(None): 4 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): a) Opinion regarding the proposed validity of the permit and, if necessary, the measures and procedures of
p.(None): monitoring and biosafety additional to those presented by the promoter;
p.(None): b) The reasons why it is determined to add such measures and procedures, and
p.(None): c) The legal provisions on which the additions mentioned in subparagraph a) of this section are based, and the
p.(None): scientific reasons that justify establishing additional measures and procedures.
p.(None): III. When unfavorable, the following will be indicated:
p.(None): a) If this is the case, the reasons why it is considered that the promoter did not address the issues
p.(None): raised in the requirement referred to in article 10 of the Regulation;
p.(None): b) The scientific or technical reasons why it is considered that the risks that could present
p.(None): The GMOs in question will adversely affect biological diversity, the environment, health
p.(None): animal, vegetable or aquaculture, and may cause serious or irreversible damage;
p.(None): c) The reasons why the requested release contravenes the Law, this Regulation and the rest
p.(None): applicable provisions, and
p.(None): d) Other determinations made by the authority in exercise of the precautionary approach established in
p.(None): the law.
p.(None): In accordance with the last paragraph of article 15 of the Law, the biosafety opinion referred to in the
p.(None): Section I of said article shall be binding on SAGARPA in the resolution of the permit applications that
p.(None): in accordance with the Law are within its competence.
p.(None): Chapter II
p.(None): Requirements for release permits to the environment
p.(None): Article 16. The information to be attached to the request for experimental release of GMOs from
p.(None): In accordance with Articles 5, 6 and 7 of this Regulation, it will be as follows:
p.(None): I. Characterization of the GMO;
p.(None): a) Unique identifier of the transformation event, of international organizations of which Mexico is a part,
p.(None): when it exists;
p.(None): b) Species related to the GMO and their distribution in Mexico;
p.(None): c) Specification of the existence of sexually compatible species;
p.(None): d) Description of habitats where GMO can persist or proliferate in the release environment;
p.(None): e) Taxonomic description of the recipient and donor organism of the genetic construction;
p.(None): f) Country and location where the GMO was collected, developed or produced;
p.(None): 5 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): g) Documentary reference on origin and diversification of the receiving agency;
p.(None): h) Detailed gene sequence of the transformation event, including size of the inserted fragment, site of
p.(None): insertion of the genetic construct, including the sequences of the oligonucleotides that allow the
...

p.(None): liberation and neighboring areas, once the liberation is concluded.
p.(None): b) Biosecurity measures and procedures:
p.(None): 1. Measures and procedures to prevent the release and dispersion of GMOs outside the area or areas where
p.(None): it tries to realize the liberation;
p.(None): 7 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): 2. Measures and procedures to reduce the access of dispersion vector organisms, or of
p.(None): persons who are not authorized to enter the area of liberation to said zone or zones;
p.(None): 3. Measures for the eradication of GMOs in areas other than those allowed;
p.(None): 4. Measures for the isolation of the area where the GMO is intended to be released experimentally;
p.(None): 5. Measures for the protection of human health and the environment, should a release event not occur
p.(None): desired, and
p.(None): 6. Methods for cleaning or final disposal of waste from release.
p.(None): The promoter must clearly distinguish the measures and procedures that will be carried out during the
p.(None): release of those that will be made after it.
p.(None): V. Background of release of the GMO in other countries, when this has been done, and must attach the information
p.(None): relevant when it is within reach of the promoter:
p.(None): a) Description of the area where the release was made;
p.(None): b) Effects of release on flora and fauna;
p.(None): c) Study of the possible risks of the release of GMOs presented in the country of origin, when it has been
p.(None): required by the authority of another country and have access to it. The description of the measures and
p.(None): established biosecurity monitoring procedures should be included in the study.
p.(None): d) In case the promoter considers it appropriate, other studies or considerations in which both are analyzed
p.(None): the contribution of the GMO to the solution of environmental, social, productive or other problems, as well as the
p.(None): socioeconomic considerations that exist regarding the release of GMOs to the environment. These analyzes
p.(None): they must be based on scientific and technical evidence, on the background on use, production and consumption,
p.(None): and may be considered by the relevant Secretariats as additional elements to decide on the
p.(None): experimental release to the environment, and consequent releases to the environment in pilot and commercial program,
p.(None): respectively, of the GMO in question, and
p.(None): e) In case of import, legalized or apostilled copy of the authorizations or official documentation proving
p.(None): that the GMO is allowed under the legislation of the country of origin, at least for experimental release,
p.(None): Translated into Spanish. The competent Secretariat, if deemed necessary, may require a simple copy of the
p.(None): Applicable legislation in force in the export country translated into Spanish.
p.(None): SAW. Considerations on the risks of technological alternatives available to contend
p.(None): with the problem for which the GMO was built, in case such alternatives exist;
p.(None): VII. Authorization number issued by HEALTH when the GMO has public health purposes or is destined for
p.(None): bioremediation In case of not having the authorization at the time of
p.(None): 8 of 30
...

p.(None): Article 28. Once the application is accepted, HEALTH will evaluate the data and documents presented with it, to
p.(None): determine if they comply with the information and requirements established in the Law, this Regulation and
p.(None): other applicable provisions. If necessary, it will prevent the promoter, in writing and only once so that
p.(None): remedy the omission.
p.(None): The deadline to carry out the evaluation and require the promoter of the information or requirements that do not conform to the
p.(None): provided in the Law, the Regulations and other applicable provisions, will be thirty business days, counted
p.(None): from the business day following the submission of the application for the procedure.
p.(None): 13 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): Article 29. The promoter will have a period of twenty business days from the day
p.(None): after the notification has taken effect, to meet the requirement referred to in the
p.(None): previous article. During this period, the resolution deadlines of the request for
p.(None): authorization, and will resume the next business day after the one on which the promoter relieves the
p.(None): request.
p.(None): After this period has elapsed without the promoter having relieved the prevention, HEALTH will discard the procedure.
p.(None): Article 30. Once the prevention referred to in article 28 of these Regulations is relieved, or if the
p.(None): requirement is not notified to the promoter or notified outside the deadline or in terms other than those established
p.(None): In said article, the authority may not dismiss the process on the grounds that it is incomplete.
p.(None): For the purposes of the provisions of article 95 of the Law, it is understood that the request was received and the information
p.(None): It is complete, in the cases in which once submitted, prevention is not done or done, it is attended by
p.(None): promoter, without prejudice to the powers conferred by article 96, section II of the Law to the authority.
p.(None): Chapter II
p.(None): Requirements and resolution of requests for authorizations
p.(None): Article 31. The information to be attached to the authorization request of the GMO, in accordance
p.(None): with articles 23 and 24 of this Regulation, it will be the following:
p.(None): I. Study of possible risks that the human use or consumption of the GMO in question could
p.(None): represent human health, which will include scientific and technical information related to their safety,
p.(None): consisting of:
p.(None): a) Receiving organism, be it plant, animal or microorganism:
p.(None): 1. Identification;
p.(None): 2. Most recent taxonomic designation;
p.(None): 3. Origin, history of safe use in food, previous experiences of use or consumption;
p.(None): 4. Pathogenicity associated with genera and species, any relevant evidence of the potential for
p.(None): production of toxic or antinutrient compounds, and
p.(None): 5. Indication of the presence of plasmids, transposons and integrons containing resistance genes to
p.(None): antimicrobials
p.(None): b) About each gene donor organism:
p.(None): 1. Most recent taxonomic classification;
p.(None): 2. History of use;
p.(None): 3. Origin, and
p.(None): 14 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): 4. Indication of the presence of plasmids, transposons and integrons containing resistance genes to
p.(None): antimicrobials
p.(None): c) In the case of genetically modified microorganisms, whether they are gene receptors or donors:
p.(None): 1. Gender, species, subspecies, strain and common name of the recipient;
...

p.(None): iii. Substantial equivalence studies, and
p.(None): II. In case of authorization requests from a GMO to be able to import them for the purposes for which
p.(None): Article 91 of the Law refers to the information and documentation proving that the GMO is authorized
p.(None): according to the legislation of the country of origin or, failing that, the interested party's declaration of non-existence
p.(None): of said situation and exposure of the elements of consideration that support the one that HEALTH can resolve the
p.(None): authorization request, and
p.(None): III. The other requirements determined by HEALTH in the NOMs derived from the Law.
p.(None): Article 32. HEALTH will decide on the request for authorization within a period not exceeding six months from
p.(None): the business day following the one that admits the request.
p.(None): It is understood that the request is admitted in cases where the request was received and the information is complete,
p.(None): in accordance with the provisions of article 30, second paragraph, of these Regulations.
p.(None): 18 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): FOURTH TITLE
p.(None): On the reconsideration of negative resolutions and the review of permits and authorizations
p.(None): Chapter I
p.(None): On the reconsideration of negative resolutions
p.(None): Article 33. For the case established in articles 67 and 98 of the Law, the request for
p.(None): reconsideration of a negative resolution on a permit or authorization must be presented
p.(None): before the authority that issued it, and must provide the elements on which the claim of the
p.(None): promoter in the same reconsideration brief.
p.(None): In the notice of reconsideration, the promoter must indicate:
p.(None): I. The identification data of the resolution and the date it was issued and
p.(None): II. The arguments and elements that demonstrate that your request adheres to the assumptions provided for in article 67
p.(None): of the law.
p.(None): Article 34. In cases where the release of GMOs to the environment has been denied, because HEALTH
p.(None): did not grant the corresponding authorization, the promoter may present simultaneously to the Secretariat
p.(None): competent and HEALTH, the request for reconsideration. However for the competent Secretariat that denied permission
p.(None): Resolve the request for reconsideration, the one submitted to HEALTH must be resolved.
p.(None): Within three business days after the corresponding reconsideration has been resolved, HEALTH will send a
p.(None): copy of its resolution to the competent Secretariat that resolved in a negative sense the request for permission or
p.(None): the authorization, so that the latter resolves the reconsideration within five business days
p.(None): following.
p.(None): Article 35. In case the request for permission had been denied based on the opinion of the SEMARNAT or in the
p.(None): opinion of SAGARPA, the competent Secretariat that resolved the permit application must deliver the
p.(None): request for reconsideration to the Secretariat that must rule or give an opinion, within a period not exceeding three business days,
p.(None): counted from when the individual has entered his reconsideration request.
...

p.(None): permanently.
p.(None): Article 51. The National Biosafety Information System shall contain:
p.(None): I. Registry information in accordance with the provisions of article 56 of this
p.(None): Regulation;
p.(None): II. National statistics on biosafety and GMO;
p.(None): III. The restricted areas and the municipality or municipalities where it is located, distinguishing:
p.(None): 22 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): a) Centers of origin and genetic diversity by species; in UTM coordinates;
p.(None): b) Protected natural areas of federal competence, in the coordinates established in its instruments of
p.(None): creation;
p.(None): c) Protected natural areas of local competence, in the coordinates established in their instruments of
p.(None): creation, in case the local authorities want these areas to be in the National System of
p.(None): Biosafety Information, and
p.(None): d) GMO free zones, in UTM coordinates.
p.(None): IV. Relevant reports and documents resulting from scientific, academic, work activities
p.(None): technicians or any other type of biosafety including the safety of GMOs, made by people
p.(None): physical or moral, national or foreign;
p.(None): V. Information on the formats of the notices referred to in article 78 of the Law and the
p.(None): communications referred to in article 59 of these Regulations, the measures taken by the permit holders or
p.(None): by those who carry out confined use activities and the measures taken by the authority, to meet the
p.(None): accidental releases or any modification in the release that may increase the possible
p.(None): risks to the environment and biological diversity when conducting experimental release activities or
p.(None): pilot program release;
p.(None): SAW. The information related to the permit applications, for the purposes of the provisions of article 33 of the Law, and
p.(None): VII.- The annual report referred to in article 53 of the Regulations.
p.(None): Article 52. The Executive Secretariat shall establish the computer system to receive the information referred to.
p.(None): the previous article, in order to incorporate it into the National Biosafety Information System.
p.(None): They will be responsible for incorporating into said computer system, within the established deadlines, which
p.(None): Below are indicated:
p.(None): I. The Secretariats, in accordance with the provisions of article 57 of these Regulations, to
p.(None): effects of the information provided in section I of the previous article;
p.(None): II. The competent Secretariat that has promoted the Agreement for the determination of a center of origin and of
p.(None): genetic diversity, for the purposes of the information provided for in section III, subsection a), of the previous article, and
p.(None): you must do so within five business days after the Agreements have been published;
p.(None): III. The SEMARNAT, for the purposes of the information provided for in section III, subsection b), of the preceding article, and
p.(None): you must do it within five business days after a natural protected area of character has been created
p.(None): federal;
p.(None): IV. SAGARPA, for the purposes of the information referring to subsection d) of section III of the previous article,
p.(None): within five business days after a GMO-free zone has been created;
p.(None): 23 of 30
...

p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): impose in its area of competence the security or urgent application measures deemed necessary for
p.(None): contend with that situation.
p.(None): In addition to the communication indicated in the first paragraph of this article, within three business days
p.(None): following the knowledge of the situation described in the previous paragraph, the permit holder or who
p.(None): carry out confined use activities must submit a written notice to the Secretariat that issued the
p.(None): permission or received permission, which will contain:
p.(None): I. Identification data of the permit or notice;
p.(None): II. The polygon where the accidental release occurred, located in UTM coordinates;
p.(None): III. Circumstances and estimated date of accidental release;
p.(None): IV. Estimated quantities of the GMO that was accidentally released;
p.(None): V. Information available to the permit holder or who carries out confined use activities on the
p.(None): possible adverse effects for biological diversity and human health;
p.(None): SAW. Attention and risk control measures applied and will be applied by the permit holder or whoever performs
p.(None): confined utilization activities, and
p.(None): VII. Name and phone number of the person who will serve as the contact point.
p.(None): Article 60. The Secretariats, in their field of competence, may order some or some of the security measures
p.(None): or of urgent application provided for in article 115 of the Law. Once the inspection certificate has been received by the
p.(None): ordering authority for inspection and surveillance acts, by personal notification or by mail
p.(None): certificate with acknowledgment of receipt, will require the interested party to execute, at their own expense and cost, the security measures or
p.(None): urgently applicable, indicating the deadlines for compliance.
p.(None): Article 61. When repatriation is imposed as a security measure, the interested party must cover the
p.(None): costs thereof, being able to transfer the expenses incurred against the person responsible for the infraction.
p.(None): Article 62. If, as a result of an inspection and surveillance visit, the imposition of measures of
p.(None): security or urgent application, the inspected must notify the competent Secretariat the
p.(None): compliance with each one, within a term of five business days counted from the expiration date of the term
p.(None): granted for the execution of each one of them.
p.(None): Article 63. When the competent Secretariat engages the alleged offender and he appears by
p.(None): written accepting the irregularities in the inspection record, the Secretariat will proceed, within
p.(None): Twenty following business days, to issue the respective resolution.
p.(None): Article 64. The administrative resolution issued shall indicate, in addition to the infractions and sanctions,
p.(None): the measures to be taken to correct the deficiencies or irregularities observed during
p.(None): the inspection and the period granted to comply with them, under the terms of the Law.
p.(None): TENTH SECOND
p.(None): On the Special Corn Protection Regime Single Chapter
p.(None): 26 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): Article 65. Activities related to genetically modified corn shall be subject to the present.
p.(None): Title, to the other general provisions applicable to GMOs, as well as to the provisions of other instruments that
p.(None): establish authority.
p.(None): Article amended DOF 06-03-2009
p.(None): Article 66. Individuals, when requesting permission for experimental release of genetically corn
p.(None): modified, in addition to the provisions of Article 16 of this Regulation, must provide the
p.(None): next:
p.(None): I. Reference materials that allow the detection, identification and quantification of genetically maize
p.(None): modified to be released, and
p.(None): II. The information required by the authorities to determine the origin of stages of release
p.(None): subsequent.
p.(None): Article added DOF 06-03-2009
p.(None): Article 67. Experimentation or release to the environment of genetically modified maize that
p.(None): Contains characteristics that prevent or limit its human or animal use or consumption, or its use in processing
p.(None): Food for human consumption.
p.(None): Article added DOF 06-03-2009
p.(None): Article 68. SAGARPA, prior to the granting of the experimental release permit, must verify
p.(None): that for the organism that is intended to be released there is no alternative conventional variety. If so,
p.(None): SAGARPA will carry out the comparative analysis between the different technological options. The result
p.(None): This analysis should be an additional element to the risk assessment study to resolve the
p.(None): permission request.
p.(None): Article added DOF 06-03-2009
p.(None): Article 69. In those cases in which it is considered that the technological development proposed by individuals,
p.(None): by means of a request for a release permit, it is contrary to article 2 of the Federal Competition Law
p.(None): Economic or that could facilitate the realization of the practices prohibited by articles 8, 9 and 10
p.(None): of the same legal system, said event must be reported, in a timely and timely manner, to the Federal Commission of
...

Orphaned Trigger Words

p.(None): 16 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): 4. Development of the expression of the transgene during the life cycle of the plant and parts where the
p.(None): insert is expressed, and
p.(None): 5. Studies of substantial equivalence applied to conditions of use or consumption in Mexico, including:
p.(None): i. True protein content, non-protein nitrogen, amino acid profile;
p.(None): ii. If a new protein has been introduced: presence and level in the different parts of the plant and in the
p.(None): proposed food, evidence of consumption in other foods, processing effects, biological function,
p.(None): digestibility;
p.(None): iii. Qualitative and quantitative composition of total lipids;
p.(None): iv. Composition of the carbohydrate fraction;
p.(None): v. Qualitative and quantitative composition of vitamins;
p.(None): saw. Presence of anti-nutritional components;
p.(None): vii. Stability during storage, especially nutrient degradation and bioavailability of nutrients,
p.(None): Y
p.(None): viii For each case, the impact of changes in the nutritional components that could be determined should be determined.
p.(None): affect the overall profile of nutrients.
p.(None): k) In the case of genetically modified microorganisms, the process by which raw materials are
p.(None): they transform into a final product, step by step, with special emphasis on the most relevant parameters for
p.(None): characterization of the final product in relation to safety and nutritional aspects;
p.(None): l) Complete toxicity studies:
p.(None): 1. Acute;
p.(None): 2. Subchronic;
p.(None): 3. Chronic in those cases where the subchronic study involves or evidences some long-term risk in the
p.(None): health, of all the products of expression of the transgenes, according to if its purpose is for use
p.(None): o human consumption, bioremedication or public health;
p.(None): 4. In the case of being used as food or for food processing, studies of the constituents of
p.(None): specific food or components that were altered as a result of the genetic modification, and
p.(None): 5. When used for the bioassay, a transgenic protein obtained from bacterial cultures,
p.(None): It must be demonstrated that the protein expressed in the GMO has the same molecular weight and immunoreactivity as the protein
p.(None): microbial
p.(None): m) Complete allergenicity studies. The relevant criteria used should include aspects
p.(None): referring to:
p.(None): 17 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): 1. Origin of the transferred genetic material;
p.(None): 2. Homology of amino acid sequences between the new protein and known allergens;
p.(None): 3. Effect of pH or enzymatic digestion;
p.(None): 4. Stability against heat or processing;
p.(None): 5. Post-transduction modifications, and
p.(None): 6. When, although there is no homology between the transgenic protein and known allergens, but the evidence
p.(None): cited enzymatic digestion, at pH and heat stability or processing, demonstrate their allergenic potential,
p.(None): should provide data from the IgE cross-reactivity analysis between a new expression protein and
p.(None): a known allergen;
p.(None): n) In the case of events with a combination of genes, the parental events involved in the generation of said
p.(None): event must be previously authorized. The information to be delivered in this particular type of GMOs ...

p.(None): of the same legal system, said event must be reported, in a timely and timely manner, to the Federal Commission of
p.(None): Competition, for the legal effects that may take place
p.(None): Article added DOF 06-03-2009
p.(None): Article 70. SAGARPA and SEMARNAT must promote in situ conservation of breeds and varieties of
p.(None): Creole corn and their wild relatives through subsidy programs or other promotion mechanisms for
p.(None): biodiversity conservation, without implying any authorization for the change of land use
p.(None): From forestry to agricultural.
p.(None): The units indicated in the previous paragraph should encourage the use of Creole corn seeds in projects
p.(None): strategic that allocate their production to specific markets and to the attention of commercial opportunities.
p.(None): Article added DOF 06-03-2009
p.(None): Article 71. The competent biosafety authorities shall promote the development of laboratories for the
p.(None): detection, identification and quantification of genetically modified corn.
p.(None): Article added DOF 06-03-2009
p.(None): Article 72. In cases where the authorities determine the unauthorized presence of genetically modified material
p.(None): modified in races, varieties and wild relatives of maize, should establish measures to eliminate,
p.(None): control or mitigate this presence. In the case of races and varieties, the attribution will correspond to the
p.(None): SAGARPA, and in the case of wild relatives, to SEMARNAT.
p.(None): 27 of 30
p.(None): REGULATION OF THE BIOSEGURITY 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): Last DOF Reform 06-03-2009
p.(None): Article added DOF 06-03-2009
p.(None): Article 73. Activities related to the special protection of corn shall have a section
p.(None): specific in the National Biosafety Information System.
p.(None): Article added DOF 06-03-2009
p.(None): TRANSITORY
p.(None): FIRST. This Regulation shall enter into force the day after its publication in the Official Gazette of the
p.(None): Federation.
p.(None): SECOND. People who currently carry out activities of confined use of GMOs for teaching purposes and
p.(None): of scientific and technological research, they must form their respective internal commissions of
p.(None): Biosafety within thirty days after the entry into force of this Regulation.
p.(None): THIRD. The HEALTH holders, SEMARNAT and SAGARPA, will publish in the Official Gazette of the Federation the
p.(None): respective agreements whereby the general public is informed that the permit applications and
p.(None): authorization, as well as biosafety notices, will be received through the pages
p.(None): electronic devices enabled for this purpose. This publication must be made within a period not exceeding twelve months
p.(None): counted from the entry into force of this Regulation.
p.(None): ROOM. To fully comply with the provisions of article 51, section III, subsection b) and 52, section III,
p.(None): of these Regulations, SEMARNAT must incorporate into the computer system determined by the Secretariat
p.(None): Executive, the information regarding the protected natural areas created until the day the
p.(None): this regulation. For this purpose, it will have a period of three months from the day after
p.(None): This Regulation enters into force.
p.(None): FIFTH. Requests for permits submitted before the entry into force of this Regulation and those
p.(None): that are submitted as long as the agreements referred to in article 86 of the Law are not issued, they must be resolved
p.(None): by the competent Secretariat after consultation with the institutions indicated in the aforementioned article. ...

Appendix

Indicator List

Indicator	Vulnerability
access	Access to Social Goods
another country	Other Country
authority	Relationship to Authority
conviction	Religion
education	education
gender	gender
indigenous	Indigenous
language	Linguistic Proficiency
native	Indigenous
opinion	philosophical differences/differences of opinion
parents	parents
party	political affiliation
political	political affiliation
property	Property Ownership
restricted	Incarcerated
single	Marital Status
substance	Drug Usage

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
indigenous	['native']
native	['indigenous']
party	['political']
political	['party']

Trigger Words

capacity

protection

risk

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Indigenous	indigenous	1
Political	Indigenous	native	1
Political	political affiliation	party	10
Political	political affiliation	political	1
Health	Drug Usage	substance	1
Social	Access to Social Goods	access	2
Social	Incarcerated	restricted	2
Social	Linguistic Proficiency	language	4
Social	Marital Status	single	9
Social	Property Ownership	property	1
Social	Religion	conviction	1
Social	education	education	2
Social	gender	gender	1
Social	parents	parents	2
Social	philosophical differences/differences of opinion	opinion	43
General/Other	Other Country	another country	1
General/Other	Relationship to Authority	authority	8

Regulation of the Biosafety Law on Genetically Modified Organisms

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / Indigenous

Political / political affiliation

Health / Drug Usage

Social / Access to Social Goods

Social / Incarcerated

Social / Linguistic Proficiency

Social / Marital Status

Social / Property Ownership

Social / Religion

Social / education

Social / gender

Social / parents

Social / philosophical differences/differences of opinion

General/Other / Other Country

General/Other / Relationship to Authority

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input