Transgênicos e o princípio de equivalência substancial / Transgenics and the principle of substantial equivalence

Objetivamos discutir os principais argumentos que estão envolvidos no debate sobre a cientificidade do Princípio de Equivalência Substancial (PES), que afirma serem os OGM quimicamente equivalentes aos organismos selecionados pelas técnicas tradicionais de melhoramento, não requerendo, portanto, estudos toxicológicos adicionais. Problematizamos a cientificidade do PES, especialmente no que diz respeito à questão propriamente química. De fato, o PES estrutura-se conceitualmente na comparação quantitativa entre alguns componentes químico-biológicos da planta transgênica e os da não transgênica. Nesse sentido, as análises químicas propostas não conseguem relacionar sozinhas os possíveis efeitos bioquímicos, toxicológicos e imunológicos dos alimentos transgênicos, pois o princípio restringe as análises à composição química, molecular e analítica dos transgênicos. Emerge assim o problema do locus da incerteza científica, seja como questão epistemológica, seja como questão normativa e moral.

We aim to discuss the main arguments involved in the debate on the scientificity of the Principle of Substantial Equivalence (PSE), which claims that GMOs are chemically equivalent to organisms selected by traditional breeding techniques and therefore do not require additional toxicological studies. We question the scientific character of the PSE, especially with regard to the chemical question itself. Indeed, the PSE is conceptually structured in the quantitative comparison between some chemical--biological components of the transgenic plant and those of the non-transgenic plant. In this sense, the proposed chemical analyses cannot by themselves assess the possi-ble biochemical, toxicological and immunological effects of transgenic foods, since the principle restricts the analysis to the chemical, molecular and analytical composition of transgenics. This gives rise to the problem of the locus of scientific uncertainty, whether as an epistemological question or as a normative and moral issue.

Discussion on Techniques of Preliminary Safety Evaluation of Transgenic Chinese Herb / 世界科学技术-中医药现代化

Insertion of foreign genes into the genome map of Chinese herb always produces the intended beneficial effects, but also the unintended effects. Analysis of genomic function and metabolic end products based on the principle of substantial can reveal the influence on the quality of herbs, which is able to provide valuable refer-ence for the following evaluation on pharmacology and toxicology.

Concepto de equivalencia sustancial aplicado alimentos derivados de cultivos genéticamente mejorados / The concept of substantial equivalence as applied to foodstuffs derived from genetically-modified crops

El objetivo del presente artículo es describir la aplicación del concepto de equivalencia sustancial, el cual es utilizado y aceptado internacionalmente para realizar la evaluación de la inocuidad de un alimento nuevo derivado de cultivos genéticamente mejorados. La metodología utilizada fue revisión de literatura actualizada, considerando, información tanto de revistas nacionales como internacionales y documentos de la Organización Mundial para la Agricultura y la Alimentación, FAO, Organización Mundial de la Salud, OMS, Codex Alimentarius, Organización Económica de Cooperación y Desarrollo, OECD, la Food and Drug Administration, FDA y otras. El artículo presenta la tendencia mundial en la siembra de cultivos genéticamente mejorados, así como la situación actual en Costa Rica con respecto a la siembra de cultivos genéticamente mejorados para incremento de semilla. Además, se detalla el concepto de equivalencia sustancial y se describe el conjunto de características de calidad que se deben evaluar los procedimientos metodológicos a seguir para demostrar que un alimento, derivado de un cultivo genéticamente mejorado, adCGM, es seguro para el consumo humano y animal. Como conclusión el concepto de equivalencia sustancial es el grupo de técnicas y metodologías, vigentes y aceptadas internacionalmente para evaluar la inocuidad de un nuevo alimento desarrollado mediante biotecnología moderna.

The objective of this article is to describe the complete application of the concept of substantial equivalence, which is internationally accepted and widely used for food safety evaluation of new foods. The methodology consists of a literature review of current documents from several agencies such as the World Health Organization (WHO), Food and Agriculture Organization of the United Nations (FAO), Organization for Economic Cooperation and Development (OECD), the Food and Drug Administration of the USA (FDA), and others. This article presents the global trends related to the planting of genetically modified crops, and the Costa Rican situation on planting genetically modified crops for increasing seed yield. The article introduces the concept of substantial equivalence, and discusses several tests that should be applied in order to demonstrate that a genetically modified food derived from a GM crop is safe for human and animal consumption. As conclusion, the concept of substantial equivalence is the internationallyand currently accepted criteria the food safety assessment of crops developed by modern biotechnology.

Factores antinutricionales presentes en el arroz pilado crudo / Anti nutritional factors present in raw, polished rice

El objetivo de este artículo fue investigar la presencia de los factores antinutricionales en el arroz pilado crudo, tales como inhibidor de la tripsina, la lectina y el ácido fítico. El estudio es parte del proyecto de investigación de la equivalencia sustancial del arroz mejorado genéticamente AS 10-7-6 y CPM 10-4-6, desarrollado por el Centro de Investigaciones de Biología Molecular y Celular de la Universidad de Costa Rica, CIBCM, en Costa Rica. La metodología utilizada fue revisión de literatura, disponible en revistas nacionales e internacionales y consulta a expertos. Se encontró que la detección de dichos antinutrientes en el arroz pilado es muy baja en arroz crudo y es aún menor en el arroz cocido, ya que la lectina y el inhibidor de la tripsina son sensibles al calor y se inactivan al cocinar el alimento. En estudios realizados el arroz mejorado genéticamente llamado Libertylink, no se encontraron diferencias en el contenido de ácido fítico al compararlo con el par convencional. Además, se encontró que el inhibidor de la tripsina sólo está presente en la granza; la lectina no fue detectada en ninguna de las presentaciones del arroz. Por lo que al considerar la información bibliográfica y los resultados del arroz LibertyLink, se concluye que la presencia de antinutrientes es baja o ninguna, en el arroz pilado de las líneas mejoradas genéticamente en estudio.

The purpose of this study was to research the presence of anti-nutrient factors such as the trypsin inhibitor, lectin and phytic acid all in raw, polished rice. This review is part of a larger research project on the substantial equivalence of AS 10-7-6 and CPM 10-4-6, genetically-modified rice developed by the Cellular and Molecular Biology Research Center (CIBCM) at the University of Costa Rica. The methodology used was a review of the literature both in national as well as in international journals and also experts´ opinion. Our results show that detection of these anti-nutrient factors in rice is low and it is very low in polished rice; the reason is that lectin and trypsin inhibitors are heat-sensitive and they are deactivated when cooked. Some studies done on genetically-modified Libertylink rice found no difference in phytic acid content when compared to non-modified rice. The trypsin inhibitor is detected only on the embryo and bran layers; lectin was not detected in any of the different rice presentations. In conclusion, according to the review done in the literature as well as the study done on Libertylink rice, it can be said that the presence of anti-nutrients in rice is expected to be low or absent in genetically-modified rice lines.