Update of Argentina’s Regulatory Policies on the Environmental Risk Assessment

The Environmental Risk Assessment (ERA) of genetically modified (GM) crops in Argentina is carried out by the National Advisory Commission on Agricultural Biotechnology (CONABIA) and the Innovation and Biotechnology Coordination (CIyB). Both have a large experience with this assessment, since 1991,...

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Main Authors: Facundo Vesprini, Agustina Ines Whelan, María Florencia Goberna, Mariana Lucía Murrone, Gabriela Evangelina Barros, Andrés Frankow, Perla Godoy, Dalia Marcela Lewi
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-01-01
Series:Frontiers in Bioengineering and Biotechnology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fbioe.2021.834589/full
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author Facundo Vesprini
Agustina Ines Whelan
María Florencia Goberna
Mariana Lucía Murrone
Gabriela Evangelina Barros
Andrés Frankow
Perla Godoy
Dalia Marcela Lewi
author_facet Facundo Vesprini
Agustina Ines Whelan
María Florencia Goberna
Mariana Lucía Murrone
Gabriela Evangelina Barros
Andrés Frankow
Perla Godoy
Dalia Marcela Lewi
author_sort Facundo Vesprini
collection DOAJ
description The Environmental Risk Assessment (ERA) of genetically modified (GM) crops in Argentina is carried out by the National Advisory Commission on Agricultural Biotechnology (CONABIA) and the Innovation and Biotechnology Coordination (CIyB). Both have a large experience with this assessment, since 1991, when CONABIA was created. The continuous support to biotechnology as a state policy and as part of the decision to encourage developers in the regulatory process has helped make progress in the revision of the regulations. The experience gained during the last 30 years and the worldwide scientific advances supported the bases to update the regulatory framework. Focusing on the biosafety strengthening and the improvement of the applicant’s experience in the GM crops evaluation process, during 2020 and 2021, the ERA went through a reviewing process. Some important modifications were made, such as (i) the assessment of stacked GM crops with focus on the possible interactions between transgenes and the expression products, (ii) the strengthening of the ERA taking into account the transportability of data and conclusions from the Confined Field Trials (CFTs), (iii) the adoption of Familiarity and History of Safe Use (HOSU) concepts on the risk assessment of the expression products, (iv) the special considerations for the unintended effects of insertional sites, and (v) as a post commercial release of GM crops, the Insect Resistance Management Plan (IRMP) was reformulated. These novel approaches enhance the ERA; they make it more efficient by applying the science criteria and the accumulated experience and scientific bibliography on the topic.
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spelling doaj.art-f5dfeebb39894b38bfa18d26c27d50e42022-12-22T04:10:13ZengFrontiers Media S.A.Frontiers in Bioengineering and Biotechnology2296-41852022-01-01910.3389/fbioe.2021.834589834589Update of Argentina’s Regulatory Policies on the Environmental Risk AssessmentFacundo VespriniAgustina Ines WhelanMaría Florencia GobernaMariana Lucía MurroneGabriela Evangelina BarrosAndrés FrankowPerla GodoyDalia Marcela LewiThe Environmental Risk Assessment (ERA) of genetically modified (GM) crops in Argentina is carried out by the National Advisory Commission on Agricultural Biotechnology (CONABIA) and the Innovation and Biotechnology Coordination (CIyB). Both have a large experience with this assessment, since 1991, when CONABIA was created. The continuous support to biotechnology as a state policy and as part of the decision to encourage developers in the regulatory process has helped make progress in the revision of the regulations. The experience gained during the last 30 years and the worldwide scientific advances supported the bases to update the regulatory framework. Focusing on the biosafety strengthening and the improvement of the applicant’s experience in the GM crops evaluation process, during 2020 and 2021, the ERA went through a reviewing process. Some important modifications were made, such as (i) the assessment of stacked GM crops with focus on the possible interactions between transgenes and the expression products, (ii) the strengthening of the ERA taking into account the transportability of data and conclusions from the Confined Field Trials (CFTs), (iii) the adoption of Familiarity and History of Safe Use (HOSU) concepts on the risk assessment of the expression products, (iv) the special considerations for the unintended effects of insertional sites, and (v) as a post commercial release of GM crops, the Insect Resistance Management Plan (IRMP) was reformulated. These novel approaches enhance the ERA; they make it more efficient by applying the science criteria and the accumulated experience and scientific bibliography on the topic.https://www.frontiersin.org/articles/10.3389/fbioe.2021.834589/fullGM cropdata transportabilitystacked GM cropsunintended effectshistory of safe useenvironmental risk assessment
spellingShingle Facundo Vesprini
Agustina Ines Whelan
María Florencia Goberna
Mariana Lucía Murrone
Gabriela Evangelina Barros
Andrés Frankow
Perla Godoy
Dalia Marcela Lewi
Update of Argentina’s Regulatory Policies on the Environmental Risk Assessment
Frontiers in Bioengineering and Biotechnology
GM crop
data transportability
stacked GM crops
unintended effects
history of safe use
environmental risk assessment
title Update of Argentina’s Regulatory Policies on the Environmental Risk Assessment
title_full Update of Argentina’s Regulatory Policies on the Environmental Risk Assessment
title_fullStr Update of Argentina’s Regulatory Policies on the Environmental Risk Assessment
title_full_unstemmed Update of Argentina’s Regulatory Policies on the Environmental Risk Assessment
title_short Update of Argentina’s Regulatory Policies on the Environmental Risk Assessment
title_sort update of argentina s regulatory policies on the environmental risk assessment
topic GM crop
data transportability
stacked GM crops
unintended effects
history of safe use
environmental risk assessment
url https://www.frontiersin.org/articles/10.3389/fbioe.2021.834589/full
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