1 Selected issues of legal regulation of genetically modified organisms Abstract Genetically modified organisms are one of the most pressing challenges of modern agriculture and other economic sectors. This is due to the large number of potential benefits and risks, which are quite often insufficiently scientifically researched, exacerbating the controversy associated with their use. It is a technology that has been used for a relatively long time, but its legal regulation is constantly challenged due to the dynamic development of the related scientific advances. Despite the aforementioned, some issues of the topic receive only marginal attention, which makes it difficult to create and apply a fully functioning legal regulation. The diploma thesis itself deals with selected issues of legal regulation of genetically modified organisms, focusing on the readiness of legal regulation, functionality of auxiliary instruments, as well as de lege ferenda considerations. These topics are formulated into three basic research questions, which the author tries to answer by analyzing relevant parts of the legal regulation. The aim of this thesis is to expand this vital part of environmental law with new findings and thus supplement other academic works that deal with legal regulation of genetically modified organisms....

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This thesis addresses the puzzle of variation in first-generation regulatory policies for controversial science and technology, as demonstrated in the cases of agricultural genetically modified organisms (GMOs) and human embryonic stem cell research in the United Kingdom and the United States. Why did policy outcomes vary in each technology case? This study answers this question by placing greater emphasis on institutional factors. Although works within institutional analysis, bureaucracy and regulation literatures make significant progress in revealing how existing institutions can shape outcomes, how far one can characterize bureaucratic behavior and whether interest groups capture regulation, they nevertheless create an opening for research that: describes a mechanism for path dependence to explain variation in policies; shows the degree to which bureaucratic behaviors can influence outcomes; and, highlights instances in which regulatory officials hold power. This thesis makes an original contribution by providing new historical details relating to these cases, and by providing an extensive elaboration of Pierson’s criteria for increasing returns and a so-called secondary test of path dependence to explain outcomes. The study recounts the biography of key policy documents in each case by tracing the process of decision-making through government and archival sources, secondary literature and more than 40 elite interviews. In doing so, it details the activities of key governmental bodies within the European Union, UK and US. Moreover, it shows how the Coordinated Framework (1986) and Human Fertilisation and Embryology Act 1990 framework represented decision-making structures which triggered changes in actors and interests and shaped permissive outcomes for GMOs and stem cell research in the US and UK, respectively. Furthermore, lack of comparable structures may help account for restrictive policies for GMOs in Europe and the UK, and for stem cell research in the US.

"Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de Maître en droit (LL.M)" / Depuis quelques années, le recours à la biotechnologie dans le secteur de l'alimentation est omniprésent. Les techniques, évoluant au gré de l'avancement de la science, permettent aux gens faisant partie de plusieurs sphères de la société, tels les scientifiques, producteurs, agriculteurs, consommateurs etc., de profiter de ces percées technologiques. Toutefois, afin d'encadrer la commercialisation de ces nouveaux produits alimentaires découlant de cette technologie, un cadre réglementaire devait, il va sans dire, être élaboré. Ce fut le cas de part et d'autre de l'Atlantique. Toutefois, bien qu'appréciée des scientifiques, cette technologie est loin de faire l'assentiment de tous. D'ailleurs, différentes perceptions se reflètent dans les différents cadres réglementaires mis de l'avant, tout aussi bien canadien que français, quant à l'utilisation et la mise en vente des nouveaux aliments. Ce travail décrit les systèmes réglementaires visant la commercialisation des aliments nouveaux tant canadien que français. Par ailleurs, il relate les différents débats, sociologique, éthique, et techniques, dont ces organismes génétiquement modifiés (OGM) sont la cible. / Since the past decades, the use of biotechnology in the industry of novel food was very considerable. This new technique is very useful, and can be easily important for an appreciable quantity of people, like productors, agricultors and consumers. Since it was used in the production of novel food, a new regulatory enforcement was needed. It was done either in France and Canada, but differently. As we know, the different way of life in both countries play an important role in the acceptance of the genetically modified organisms (GMO's). In this thesis, we will give a description of the different regulatory frameworks for food products of biotechnology. Then, we will see what was important, according to the different sociologie and ethics point of view, in the elaboration of these relevant legislation.

O melhoramento genético clássico de sementes milho (Zea mays L.) permitiu desenvolver inúmeras variedades, incluindo o milho com qualidade proteica melhorada (Quality Protein Maize, QPM), que visava aumentar os teores proteicos e as propriedades nutricionais. Por outro lado, novas variedades comerciais foram obtidas por vegetais geneticamente modificados (GM), com foco em parâmetros agronômicos. Em ambos os casos, a segurança dessas variedades para uso como alimento é uma das principais preocupações dos desenvolvedores e dos órgãos de regulamentação. A Equivalência Substancial é a base do sistema de avaliação da segurança de culturas geneticamente modificadas, no entanto alterações na expressão de proteínas não são devidamente analisadas e esclarecidas. As abordagens proteômicas complementam as técnicas de avaliação de biossegurança para alimentos GM, bem como permitem investigar possíveis efeitos indesejáveis derivados do melhoramento clássico. Os objetivos do presente estudo foram caracterizar e comparar os perfis proteicos de variedades de milhos convencionais melhorados (QPM) e geneticamente modificados (GMs), contra suas respectivas linhas convencionais utilizando técnicas proteômicas como eletroforese bidimensional (2-DE) e bottom up shotgun (gel-free). Num primeiro estudo, foram utilizadas três amostras de milho, sendo duas variedades convencionais com QPM (QP1 e QP2) e uma variedade convencional normal (CN). No segundo estudo, foram analisadas duas cultivares de milho GM (GM1 e GM2) e seus respectivos convencionais genitores (CG1 e CG2). As composições químicas de todas as amostras também foram avaliadas quanto a Equivalência Substancial. O extrato bruto proteico foi submetido à análise de eletroforese unidimensional (1-DE), bidimensional (2-DE) e bottom up shotgun (gel-free). As imagens dos mapas proteicos foram analisadas pelo software Image Master 2D Platinum 7.0 (GE). Os spots diferencialmente expressos e selecionados foram sequenciados por MS. Pela composição química das principais frações das amostras de milho foi possível identificar a equivalência substancial entre as amostras convencionais e GMs, bem como QPMs e sua convencional dentro das faixas de variabilidade esperadas da espécie. Nos géis 1-DE foram observadas bandas proteicas com perfis similares entre os grupos de amostras avaliadas para ambos estudos. Nas imagens dos géis 2-DE não houveram alterações extremas entre as amostras de milhos GMs e seus respectivos convencionais genitores (CGs), mas apenas diferenças na intensidade dos spots proteicos. As variedades QPMs e CN apresentaram diferenças devido à distribuição dos spots. Os mapas proteicos das amostras CG1 x GM1 e CG2 x GM2 apresentaram maior semelhança com porcentagens de matchings superiores a 70 %, enquanto as porcentagens de matchings entre variedades diferentes (QPMs e CN) foram menores. No total foram identificadas 219 proteínas das amostras CGs x GMs e QPMs x CN, classificadas quanto aos seus processos biológicos e função molecular. Em conclusão, foram encontradas diferenças entre os cultivares GMs e CGs, indicando uma variação normal entre variedades de milho, que não comprometem a segurança alimentar das amostras estudadas. Quanto às amostras com QPM e CN as diferenças encontradas são devido à sua distância nas linhagens ou germoplasma. / The classic genetic breeding of corn seeds (Zea mays) has enabled the development of many varieties, including corn with improved protein quality (Quality Protein Maize, QPM), which aimed to increase protein levels and nutritional properties. On the other hand, new commercial varieties have been obtained out of genetically modified (GM) vegetables, with a focus in agronomic parameters. In both cases, the safety of these varieties for food use is one of the main concerns for the developers and for the regulatory agencies. Substantial Equivalence is the basis of the safety evaluation system for genetically modified crops, however, alterations in the protein expressions are not been properly analyzed and clarified. The protein approaches complement the techniques of biosafety evaluation for GM foods, as well as allow for possible undesirable effects derived from classic improvement to be investigated. The goals of the current studies were to characterize and compare the protein profiles of the different varieties of conventionally improved (QPM) and genetically modified (GM) corn, against their respective conventional lines using proteomic techniques, such as, two-dimensional electrophoresis (2-DE), bottom up shotgun (gel-free) and masses spectrometry (MS). In a first instance of the study, three samples of corn were used, two of conventional varieties with QPM (QP1 and QP2) and one conventional normal variety (CN). In a second instance of the study, two cultures of GM corn (GM1 and GM2) were analyzed and their respective conventional genitors (CG1 and CG2). The chemical compositions of all the samples were also evaluated for their Substantial Equivalence. The protein raw extract was submitted to analysis of one-dimensional (1-DE), two-dimensional (2-DE) electrophoresis, and bottom up shotgun (gel-free). The protein image maps were analyzed by the Image Master 2D Platinum 7.0 (GE) software. The spots which were expressed and selected differentially were sequenced by MS. By the chemical composition of the main fractions of the samples of corn, it was possible to identify the substantial equivalence between the conventional samples and GMs, likewise with OPMs and their conventional in the ranges of variability which were expected for the species. On the 1-DE gel, it was observed protein bands with similar profiles amongst the groups of evaluated samples for both studies. In the images of the 2-DE gel, there were no alterations between the GM corn and their respective conventional genitors (CGs), but only differences in intensity of the protein spots. The OPM and CN varieties presented differences due to the distribution of the spots. The protein maps of samples CG1 vs. GM1 and CG2 vs. GM2 presented greater similarities with the percentages of matchings superior to 70%, while the percentage of matchings among different varieties (QPMs and CN) were smaller. In total, there were 219 proteins identified in the samples CGs vs. GMs and QPMs vs. CN, classified by the biologic processes and molecular function. In conclusion, there were found differences between the cultures of GMs and CGs, indicating a normal variation among the corn varieties, which do not affect the food security of the studied samples. As per the samples with QPM and CN, the differences found were due to the line distances or germplasm.

[pt] O presente trabalho tem como objetivo analisar alguns aspectos concernentes às recentes inovações tecnológicas, e suas conseqüências para o meio ambiente. Embora não exista desenvolvimento social sem o progresso econômico e cientifico, não se pode conceber a existência de um Estado Democrático de Direito sem a preservação ambiental. A consolidação dos direitos e garantias fundamentais só é possível com a concretização do desenvolvimento sustentável, hoje tido como mera utopia. Como forma de mitigar as constantes agressões aos ecossistemas, estuda-se como a modernidade influencia na formação da Sociedade de Risco, marcada pela existência de graves situações que por muitas vezes passam desapercebidas, mas representam profundas ameaças para a humanidade. O projeto moderno mostra-se, hoje, como impraticável graças aos seus próprios fundamentos. Trata-se do contexto da modernização reflexiva. Acredita-se que mediante a adoção do postulado da cautela, concretizada pelo princípio da precaução, estar-se-á dando um importante passo para o controle dos riscos existentes. O Brasil enfrenta no presente momento tais questões, dada a necessidade de regulamentação da produção e consumo dos organismos geneticamente modificados, também conhecidos como alimentos transgênicos. Nesse caso, o instrumento normativo que irá disciplinar o uso do princípio da precaução em nosso país pode ser um importante instrumento de defesa desta concepção democrática da interpretação da legislação ambiental, inclusive no campo da hermenêutica constitucional. / [en] This work is intended to analyze some aspects concerning the recent technological innovations, and their consequence to the ambient. Although there is no social development without economic progress, we cannot conceive the existence of a rightfull Democratic State without the preservation of the ambient. The consolidation of the rights and fundamental warranties is only possible with the concretization of sustained development, today considered as utopic. As a way to mitigate the continuous agressions to the ecosystem, we study how modernity influences the formation of the Risk Society, marked by the existance of serious situations that many times go unperceived, but represent a profound menace for humanity. The modern project seems, today, unpracticable thanks to his own foundations. It is believed that, through the adoption of a postulate of caution, concreted by the caution principle, an important step is given for the control of risks. At present, Brasil is living these questions, due to the necessity to regulate the production and use of genetically modified organisms, also known as transgenic foods. In this case, the normative instrumets that are going to disciplinate the use of the principle of caution in our country may be an important instrument of defense of this democratic conception of the interpretation of ambiental laws, inclusive in the field of democratic hermeneutic.

Depuis quelques années, le recours à la biotechnologie dans le secteur de l'alimentation est omniprésent. Les techniques, évoluant au gré de l'avancement de la science, permettent aux gens faisant partie de plusieurs sphères de la société, tels les scientifiques, producteurs, agriculteurs, consommateurs etc., de profiter de ces percées technologiques. Toutefois, afin d'encadrer la commercialisation de ces nouveaux produits alimentaires découlant de cette technologie, un cadre réglementaire devait, il va sans dire, être élaboré. Ce fut le cas de part et d'autre de l'Atlantique. Toutefois, bien qu'appréciée des scientifiques, cette technologie est loin de faire l'assentiment de tous. D'ailleurs, différentes perceptions se reflètent dans les différents cadres réglementaires mis de l'avant, tout aussi bien canadien que français, quant à l'utilisation et la mise en vente des nouveaux aliments. Ce travail décrit les systèmes réglementaires visant la commercialisation des aliments nouveaux tant canadien que français. Par ailleurs, il relate les différents débats, sociologique, éthique, et techniques, dont ces organismes génétiquement modifiés (OGM) sont la cible. / Since the past decades, the use of biotechnology in the industry of novel food was very considerable. This new technique is very useful, and can be easily important for an appreciable quantity of people, like productors, agricultors and consumers. Since it was used in the production of novel food, a new regulatory enforcement was needed. It was done either in France and Canada, but differently. As we know, the different way of life in both countries play an important role in the acceptance of the genetically modified organisms (GMO's). In this thesis, we will give a description of the different regulatory frameworks for food products of biotechnology. Then, we will see what was important, according to the different sociologie and ethics point of view, in the elaboration of these relevant legislation. / "Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de Maître en droit (LL.M)"

Magistro baigiamajame darbe atskleista, kad daugelis respondentų yra neapsisprendę dėl savo pozicijos GMO gamybos bei naudojimo atžvilgiu, tačiau beveik trečdalis asmenų GMO gamybai bei naudojimui nepritaria. Dauguma gyventojų mano, kad GMO ne tik kenkia žmogaus sveikatai, bet ir yra pavojingi, taip pat kenkia aplinkai, o GMO turinčių produktų naudojimas gali negrįžtamai pakeisti genetinį žmogaus kodą ir augalų bei gyvūnų populiacijose gali sukelti negrįžtamus mutacinius pokyčius. Vis dėlto GMO produkciją kai kurie gyventojai linkę naudoti dėl mažesnės jų kainos ir ilgesnio vartojimo galiojimo termino. Nors kai kurie respondentai ir buvo įsitikinę GMO teikiama nauda bei tolimesniu GMO gamybos bei naudojimo plitimu ateityje, tačiau beveik visi respondentai buvo įsitikinę ir tuo, jog GMO gamyba bei naudojimu labiausiai suinteresuotos yra kuo didesnio pelno siekiančios monopolinės kampanijos. Vienareikšmiškai galima teigti, jog nors gyventojai apie GMO informacijos daugiausiai ir gauna iš televizijos laidų, pokalbių su draugais pažįstamais ar giminaičiais bei iš spaudos leidinių arba naršydami internete, tačiau tos informacijos kiekis yra nepakankamas ir daugiau kaip pusė respondentų norėtų, jog informacijos apie GMO būtų pateikiama daugiau. / The Master’s final paper on GMO discovered that the majority of respondents have no strong opinion about production and use of GMO, but one third of responses on production and use of GMO were negative. Many people consider that GMO not only negatively affect human health, but also damage environment. Moreover, eating genetically-modified food can irreversibly change human’s genetic code as well as irreversible mutations in plants’ and animals’ populations. However, some people tend to use GM foods because they are cheaper and can be stored longer than other foods. Even though some of the respondents see benefits of GMO production and usage, almost all of the respondents claim that genetically engineered products interest mostly large companies that are seeking to profit from GMO. The most obvious finding to emerge from this study is that people learn about GMO from mass media and communicating with friends and relatives mostly, but they also admit the lack of credible information on GMO. More than a half of the respondents would like to receive more information about genetically modified organisms.

Philosophiae Doctor - PhD / Electroanalytical and optical properties of nanoscale materials are very important for biosensing applications as well as for understanding the unique one-dimensional carrier transport mechanism. One-dimensional semiconductor nanomaterials such as semiconductor quantum dots are extremely attractive for designing high-density protein arrays. Because of their high surfaceto-volume ratio, electro-catalytic activity as well as good biocompatibility and novel electron transport properties make them highly attractive materials for ultra-sensitive detection of biological macromolecules via bio-electronic or bio-optic devices. A genosensor or gene based biosensor is an analytical device that employs immobilized deoxyribonucleic acid (DNA) probes as the recognition element and measures specific binding processes such as the formation of deoxyribonucleic acid-deoxyribonucleic acid (DNA-DNA), deoxyribonucleic acid- ribonucleic acid (DNA-RNA) hybrids, or the interactions between proteins or ligand molecules with DNA at the sensor surface.In this thesis, I present four binary and two ternary-electrochemically and optically modulated selenide and telluride quantum dots, all synthesised at room temperature in aqueous media. Cationic gallium (Ga3+) synthesized in form of hydrated gallium perchlorate salt[Ga(ClO4)3.6H2O] from the reaction of hot perchloric acid and gallium metal was used to tailor the optical and electrochemical properties of the selenide and telluride quantum dots. The synthesized cationic gallium also allowed successful synthesis of novel water soluble and biocompatible capped gallium selenide nanocrystals and gallium telluride quantum dots. Cyclic voltammetric studies inferred that presence of gallium in a ZnSe-3MPA quantum dot lattice improved its conductivity and significantly increased the electron transfer rate in ZnTe-3MPA.Utraviolet-visible (UV-vis) studies showed that incorporation of gallium into a ZnSe-3MPA lattice resulted in a blue shift in the absorption edge of ZnSe-3MPA from 350 nm to 325 nm accompanied by decrease in particle size. An amphiphilic bifunctional molecule, 3-Mercaptopropionic acid (3-MPA) was used as a capping agent for all quantum dots. It was found that 3-MPA fully solubilised the quantum dots, made them stable, biocompatible, non agglomerated and improved their electron transfer kinetics when immobilized on gold electrodes.Retention of the capping agent on the quantum dot surface was confirmed by Fourier transform infrared spectroscopy (FTIR) which gave scissor type bending vibrations of C-H groups in the region 1365 cm-1 to 1475 cm-1, stretching vibrations of C=O at 1640 cm-1, symmetric and asymmetric vibrations of the C-H in the region 2850 cm-1 to 3000 cm-1 as well as stretching vibrations of –O-H group at 3435 cm-1. The particle size and level of non-agglomeration of the quantum dots was studied by high resolution transmission electron microscopy (HRTEM). The optical properties of the quantum dots were studied using UV-vis and fluorescence spectroscopic techniques.Quantum dot/nanocrystal modified gold electrodes were prepared by immersing thoroughly cleaned electrodes in the quantum dot/nanocrystal solution, in dark conditions for specific periods of time. The electrochemical properties of the modified electrodes were characterized by cyclic voltammetry (CV), square wave voltammetry (SWV), electrochemical impedance and spectroscopy (EIS). Six sensing platforms were then prepared using quantum dot/nanocrystal, one of which was used for detection of dopamine while the rest were used for detection of a DNA sequence related to 5-enolpyruvylshikimate-3-phosphate synthase, a common vector gene in glyphosate resistant transgenic plants.The first sensing platform, consisting of ZnSe-3MPA modified gold electrode (Au|ZnSe-3MPA) gave rise to a novel method of detecting dopamine in presence of excess uric acid and ascorbic acid. Using a potential window of 0 to 400 mV, the ZnSe-3MPA masked the potential for oxidation of uric and ascorbic acids, allowing detection of dopamine with a detection limit of 2.43 x 10-10 M (for SWV) and 5.65 x 10-10 M (for steady state amperometry), all in presence of excess uric acid (>6500 higher) and ascorbic acid (>16,000 times higher). The detection limit obtained in this sensor was much lower than the concentration of dopamine in human blood(1.31 x 10-9 M), a property that makes this sensor a potential device for detection of levels of dopamine in human blood.The other sensing platforms were prepared by bioconjugation of amine-terminated 20 base oligonucleotide probe DNA (NH2-5′-CCC ACC GGT CCT TCA TGT TC-3′) onto quantum dot modified electrodes with the aid of 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide hydrochloride (EDC) and N-hydroxysuccinimide (NHS). The prepared DNA electrodes were electrostatically hybridized with different sequences which included 5′-GAA CAT GAA GGA CCG GTG GG-3′ (complementary target), 5′-CATAGTTGCAGCTGCCACTG-3′ (non complementary target) and 5′-GATCATGAAGCACCGGAGGG-3′ (3-base mismatched target).The hybridization events were monitored using differential pulse voltammetry (DPV) and SWV by monitoring the guanine oxidation signal or using EIS by monitoring changes in the charge transfer resistance. The quantum dot genosensors were characterized by low detection limits (in the nanomolar range), long linear range (40 - 150 nM) and were able to discriminate among complementary, non-complementary and 3-base mismatched target sequences.

O melhoramento genético clássico de sementes milho (Zea mays L.) permitiu desenvolver inúmeras variedades, incluindo o milho com qualidade proteica melhorada (Quality Protein Maize, QPM), que visava aumentar os teores proteicos e as propriedades nutricionais. Por outro lado, novas variedades comerciais foram obtidas por vegetais geneticamente modificados (GM), com foco em parâmetros agronômicos. Em ambos os casos, a segurança dessas variedades para uso como alimento é uma das principais preocupações dos desenvolvedores e dos órgãos de regulamentação. A Equivalência Substancial é a base do sistema de avaliação da segurança de culturas geneticamente modificadas, no entanto alterações na expressão de proteínas não são devidamente analisadas e esclarecidas. As abordagens proteômicas complementam as técnicas de avaliação de biossegurança para alimentos GM, bem como permitem investigar possíveis efeitos indesejáveis derivados do melhoramento clássico. Os objetivos do presente estudo foram caracterizar e comparar os perfis proteicos de variedades de milhos convencionais melhorados (QPM) e geneticamente modificados (GMs), contra suas respectivas linhas convencionais utilizando técnicas proteômicas como eletroforese bidimensional (2-DE) e bottom up shotgun (gel-free). Num primeiro estudo, foram utilizadas três amostras de milho, sendo duas variedades convencionais com QPM (QP1 e QP2) e uma variedade convencional normal (CN). No segundo estudo, foram analisadas duas cultivares de milho GM (GM1 e GM2) e seus respectivos convencionais genitores (CG1 e CG2). As composições químicas de todas as amostras também foram avaliadas quanto a Equivalência Substancial. O extrato bruto proteico foi submetido à análise de eletroforese unidimensional (1-DE), bidimensional (2-DE) e bottom up shotgun (gel-free). As imagens dos mapas proteicos foram analisadas pelo software Image Master 2D Platinum 7.0 (GE). Os spots diferencialmente expressos e selecionados foram sequenciados por MS. Pela composição química das principais frações das amostras de milho foi possível identificar a equivalência substancial entre as amostras convencionais e GMs, bem como QPMs e sua convencional dentro das faixas de variabilidade esperadas da espécie. Nos géis 1-DE foram observadas bandas proteicas com perfis similares entre os grupos de amostras avaliadas para ambos estudos. Nas imagens dos géis 2-DE não houveram alterações extremas entre as amostras de milhos GMs e seus respectivos convencionais genitores (CGs), mas apenas diferenças na intensidade dos spots proteicos. As variedades QPMs e CN apresentaram diferenças devido à distribuição dos spots. Os mapas proteicos das amostras CG1 x GM1 e CG2 x GM2 apresentaram maior semelhança com porcentagens de matchings superiores a 70 %, enquanto as porcentagens de matchings entre variedades diferentes (QPMs e CN) foram menores. No total foram identificadas 219 proteínas das amostras CGs x GMs e QPMs x CN, classificadas quanto aos seus processos biológicos e função molecular. Em conclusão, foram encontradas diferenças entre os cultivares GMs e CGs, indicando uma variação normal entre variedades de milho, que não comprometem a segurança alimentar das amostras estudadas. Quanto às amostras com QPM e CN as diferenças encontradas são devido à sua distância nas linhagens ou germoplasma. / The classic genetic breeding of corn seeds (Zea mays) has enabled the development of many varieties, including corn with improved protein quality (Quality Protein Maize, QPM), which aimed to increase protein levels and nutritional properties. On the other hand, new commercial varieties have been obtained out of genetically modified (GM) vegetables, with a focus in agronomic parameters. In both cases, the safety of these varieties for food use is one of the main concerns for the developers and for the regulatory agencies. Substantial Equivalence is the basis of the safety evaluation system for genetically modified crops, however, alterations in the protein expressions are not been properly analyzed and clarified. The protein approaches complement the techniques of biosafety evaluation for GM foods, as well as allow for possible undesirable effects derived from classic improvement to be investigated. The goals of the current studies were to characterize and compare the protein profiles of the different varieties of conventionally improved (QPM) and genetically modified (GM) corn, against their respective conventional lines using proteomic techniques, such as, two-dimensional electrophoresis (2-DE), bottom up shotgun (gel-free) and masses spectrometry (MS). In a first instance of the study, three samples of corn were used, two of conventional varieties with QPM (QP1 and QP2) and one conventional normal variety (CN). In a second instance of the study, two cultures of GM corn (GM1 and GM2) were analyzed and their respective conventional genitors (CG1 and CG2). The chemical compositions of all the samples were also evaluated for their Substantial Equivalence. The protein raw extract was submitted to analysis of one-dimensional (1-DE), two-dimensional (2-DE) electrophoresis, and bottom up shotgun (gel-free). The protein image maps were analyzed by the Image Master 2D Platinum 7.0 (GE) software. The spots which were expressed and selected differentially were sequenced by MS. By the chemical composition of the main fractions of the samples of corn, it was possible to identify the substantial equivalence between the conventional samples and GMs, likewise with OPMs and their conventional in the ranges of variability which were expected for the species. On the 1-DE gel, it was observed protein bands with similar profiles amongst the groups of evaluated samples for both studies. In the images of the 2-DE gel, there were no alterations between the GM corn and their respective conventional genitors (CGs), but only differences in intensity of the protein spots. The OPM and CN varieties presented differences due to the distribution of the spots. The protein maps of samples CG1 vs. GM1 and CG2 vs. GM2 presented greater similarities with the percentages of matchings superior to 70%, while the percentage of matchings among different varieties (QPMs and CN) were smaller. In total, there were 219 proteins identified in the samples CGs vs. GMs and QPMs vs. CN, classified by the biologic processes and molecular function. In conclusion, there were found differences between the cultures of GMs and CGs, indicating a normal variation among the corn varieties, which do not affect the food security of the studied samples. As per the samples with QPM and CN, the differences found were due to the line distances or germplasm.