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CRISPR in Latin America and the Caribbean

Assessment of the Regulatory and Institutional Framework for Gene-editing via CRISPR-based Technologies

About

Focus countries for the regional analysis will include: Argentina, Bolivia, Brazil, Colombia, Honduras, Mexico, Paraguay, Peru, and Uruguay.

Why is it important to study the impact of gene editing in agriculture for the LAC region?

Genome editing tools have promised tremendous opportunities in agriculture for the breeding of crops and livestock across the food supply chain. Potentially addressing issues associated with a growing global population, sustainability concerns, and possibly help address the effects of climate change (Kuiken, Barrangou, and Grieger 2021). These promises come along-side environmental, cultural and socio-economic risks. Including concerns that governance systems are not keeping pace with the technological developments and are ill-equipped, or not well suited to evaluate risks new genome editing tools may introduce. Understanding these complex, dynamic interactions across the LAC region is important to inform appropriate and acceptable governance and investment strategies for the region.

Genome engineering, genome editing, and gene editing are terms that are often used interchangeably; but have distinctions. They can also be referred to as New Plant-Breeding Technologies (NPBT). According to Robb et al. genome engineering is a process, or field, where the sequence(s) of DNA are designed and modified. Genome editing and gene editing are both techniques used for genome engineering that incorporate site-specific modifications into genomic DNA using DNA repair mechanisms. Gene editing can be distinguished from genome editing in that it typically focuses only on one gene.  Whereas genome editing refers to the targeted changes to non-gene regions in the hopes of inserting new genes or to modify gene-regulatory regions in order to manipulate the functions of existing genes. Genome editing has also been compared to other breeding methodologies (e.g. conventional breeding and genetic modification), where the distinctions can be important, particularly for risk assessments and regulatory decision-making.

What will this project investigate?

The Inter-American Development Bank has partnered with North Carolina State University’s Genetic Engineering and Society (GES) Center to assess the regulatory and institutional frameworks surrounding gene-editing via CRISPR-based technologies in the Latin America and Caribbean (LAC) regions.

The project will study the following core components:

  • Current Policy Evaluation:
    Understanding what the future may hold requires a critical examination of the current status of the regulatory landscape. What are the existing regulatory systems for agricultural biotechnologies throughout Latin America? How have they included considerations for novel biotechnology strategies such as gene editing through CRISPR technologies? Further, what about the key trade partners for the region (e.g., USA, EU, China, Japan) – what reforms have been made and what is potentially on the horizon? How are discussions at the international level likely to impact the region, such as debates within the United Nations Convention on Biological Diversity?
  • Forecasting and Future Policy Scenario Analysis:
    Potential products created through gene editing may face very different situations on the ground, depending on countries’ diverse regulations and market structures. To clarify the potential impacts of regulatory reforms, we will include concrete case studies in our analysis. The dimensions of the analysis will be holistic, to include economic, trade, and social consequences of potential policy directions.
  • Identifying Bank investment priorities:
    The diversity of the region naturally means that countries will have unique priorities and needs with respect to investment in the agricultural biotechnology development and regulatory infrastructure. We will document the accomplishments of the region in the development of gene edited products, highlighting both private and public sector innovations. We will also evaluate the gaps in capacity for development and evaluation of CRISPR-based innovations.

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Project Resources

CoverDescription/Descripción
Broad illustration of some differences in LAC countries’ regulation and key policy aspects.

Assessing agricultural gene editing regulation in Latin America: an analysis of how policy windows and policy entrepreneurs shape agricultural gene editing regulatory regimes

Type: Peer-reviewed publication; English
June 2023
Author(s):  Sebastian Zarate, Ilaria Cimadori, Michael S. Jones, Maria Mercedes Roca, S. Kathleen Barnhill

This article explores the new developments and challenges of agricultural Gene Editing (GED) regulation in primarily nine countries of Latin America and the Caribbean (LAC) Region: Argentina, Bolivia, Brazil, Colombia, Guatemala, Honduras, Mexico, Paraguay and Peru. As Gene Editing technology develops, Latin America and the Caribbean regulatory regimes struggle to keep pace. Developers and regulators face challenges such as consumer perceptions, intellectual property, R&D funding (private and public), training, environmental and social impact, and access to domestic and international markets. This is perhaps the first comparative analysis of gene editing regulation and policy in Latin America.

Zarate, S., Cimadori, I., Jones, M. S., Roca, M. M., & Barnhill, S.K. (2023). Assessing agricultural gene editing regulation in Latin America: An analysis of how policy windows and policy entrepreneurs shape agricultural gene editing regulatory regimes. Frontiers in Bioengineering and Biotechnology, 11, 1209308. doi: 10.3389/fbioe.2023.1209308.

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EnglishDocument/Documento
IDB big report cover-EN

Assessment of the Regulatory and Institutional Frameworks for Agricultural Gene Editing via CRISPR-Based Technologies in Latin America and The Caribbean

Type: Final Report; English
March 2023
Author(s): Luciana Ambrozevicius, Margo Bagley, Margo Bagley, Katie Barnhill-Dilling, Ilaria Cimadori, Michael S. Jones, Todd Kuiken, Jennifer Kuzma, Maria Mercedes Roca, Sebastián Zarate

This final report consolidates the following individual policy briefs and discussion documents:

  1. Regional Regulatory Overview (Kuzma and Kuiken, July 2021)
  2. CRISPR Patent and Licensing Policy (Bagley, July 2021)
  3. Stakeholder Interviews (Zarate, Cimadori, Roca, Jones and Barnhill-Dilling, January 2023)
  4. Case Study: Gene-Edited Sugarcane: Brazil and Bolivia (Ambrozevicius, Jones and Bagley, March 2023)
  5. Case Study: Gene-Edited, Disease-resistant Banana in Honduras and Guatemala (Jones and Roca, with contributing author José Falck, March 2023)
  6. Conclusion and Summary of Investment Need Findings (Jones and Roca, March 2023)

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EnglishDocument/Documento
IDB big report cover-ES

Evaluación del Marco Regulatorio e Institucional para la Edición Génica Agrícola mediante Tecnologías Basadas en CRISPR en América Latina y el Caribe

Type: Reporte final; español
Marzo 2023
Author(s): Luciana Ambrozevicius, Margo Bagley, Margo Bagley, Katie Barnhill-Dilling, Ilaria Cimadori, Michael S. Jones, Todd Kuiken, Jennifer Kuzma, Maria Mercedes Roca, Sebastián Zarate

Este reporte final consolida los siguientes informes de políticas individuales y documentos de discusión:

  1. Resumen Del Marco Regulatorio Regional (Kuzma y Kuiken, Julio 2021)
  2. Politicas de Patentes y Licencias CRISPR (Bagley, Julio 2021)
  3. Entrevistas con Stakeholders (Zarate, Cimadori, Roca, Jones y Barnhill-Dilling, Enero 2023)
  4. Estudio de Caso: Caña de Azúcar Editada Genéticamente: Brasil y Bolivia (Ambrozevicius, Jones y Bagley, Marzo 2023)
  5. Estudio de Caso: El Banano Editado Por Edición Génica en Honduras Y Guatemala (Jones y Roca, con autor colaborador José Falck, Marzo 2023)
  6. Conclusión y Resumen de Inversiones Necesarias (Jones y Roca, Marzo 2023)

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EspañolDocument/Documento
IDB big report cover-PT

Avaliação do Marco Regulatório e Institucional das Tecnologias de Edição Gênica Usando CRISPR no Setor Agrícola na América Latina e no Caribe

Type: Relatório final; portugués
Março 2023
Autores: Luciana Ambrozevicius, Margo Bagley, Margo Bagley, Katie Barnhill-Dilling, Ilaria Cimadori, Michael S. Jones, Todd Kuiken, Jennifer Kuzma, Maria Mercedes Roca, Sebastián Zarate

Este relatório final consolida os seguintes relatórios de política individuais e documentos de discussão:

  1. Panorama regulatório regional (Kuzma e Kuiken, julho 2021)
  2. Patente CRISPR e política de licenciamento (Bagley, julho 2021)
  3. Entrevistas com stakeholders (Zarate, Cimadori, Roca, Jones e Barnhill-Dilling, janeiro 2023)
  4. Estudo de caso: Cana-de-açúcar com edição gênica: Brasil e Bolívia (Ambrozevicius, Jones e Bagley, março 2023)
  5. Estudo de caso: Edição gênica em banana com resistência em Honduras e na Guatemala (Jones e Roca, con autor colaborador José Falck, março 2023)
  6. Conclusão e resumo das descobertas sobre a necessidade de investimento (Jones e Roca, março 2023)

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PortuguésDocument/Documento
Bagley IP-BA pres thumb

CRISPR Patent and Licensing Policy

Type: Presentation; English
May 2023
Author(s): Margo Bagley

Buenos Aires presentation on the CRISPR Patent and Licensing policy brief.

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Español, EnglishPresentation/Presentación
Jones IDB final-BA pres thumb

Presentación final de Proyecto

Type: Presentación, español
May 2023
Author(s): Michael S. Jones

Buenos Aires presentation on the final report of the IDB CRISPR in LAC project.

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EspañolPresentation/Presentación
IDB Presentation cover image 8-24-22

Final Presentation on the NCSU/IDB Gene Editing for the Agriculture in LAC/Presentación Final del Proyecto NCSU/BID sobre Edición Génica aplicada a la Agricultura en ALC

Type: Presentation; English/Spanish
August 2022
Author(s): Project team

Final results and recommendations from the collaboration between IDB and the GES Center titled “Assessment of the Regulatory and Institutional Framework for Agricultural Gene-editing via CRISPR-based Technologies in Latin America and the Caribbean”:

  • Describe our findings regarding stakeholder interviews, case studies of gene-edited banana and sugarcane, and investment recommendations.
  • Describe our findings including two policy briefs: one about intellectual property in the region and a second summarizing ongoing regulatory developments in the region.

___________________________

Dichos resultados serán presentados en una reunión virtual que tendrá lugar el día 24 de Agosto de 10:00 am a 12:30 EST, en la cual esperamos contar con su presencia. En dicha reunión abordaremos los siguientes temas:

  • Describiremos nuestros hallazgos en base de las entrevistas realizadas con los actores involucrados, estudios del banano y caña de azúcar editados, y recomendaciones de inversión.
  • Describiremos nuestros hallazgos incluyendo dos documentos de análisis de política pública: el primero sobre propiedad intelectual y el segundo sintetizando los avances regulatorios en la región.

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Español, EnglishPresentation/Presentación
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Stakeholder Interviews - Overview and Analysis

Type: Discussion document; English
Jan. 2023
Author(s): Sebastián Zarate, Ilaria Cimadori, Maria Mercedes Roca, Michael S. Jones, and Katie Barnhill-Dilling

In order to help understand the complex issues influencing the regulatory and institutional frameworks for agricultural gene editing technologies in the LAC , the project team conducted forty-one semi-structured interviews with subject matter experts and other stakeholders in eleven countries. This overview and analysis includes challenges, priorities, and suggestions for IDB investments.

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EnglishDocument/Documento
Kuzma-Reg-IDB_cover

Genome Editing in Latin America: Regional Regulatory Overview

Type: Discussion document; English
Jul 2021
Author(s): Kuiken, Todd; Kuzma, Jennifer

As discussed throughout this document, many countries in the LAC region have established genome editing specific governance systems while others have not specifically implemented genome editing specific governance systems and appear to include them in their current biosafety frameworks. While much of the LAC region appears to be coalescing around a similar interpretation of how genome editing will be governed, it is not yet clear if or how international treaties governing these tools (e.g., Cartagena Protocol on Biosafety to the Convention on Biological Diversity) will ultimately decide. This discussion document is a starting point at assessing the landscape of genome editing oversight in LAC, and it provides a broad overview of the state of GMO crops and gene edited crops governance in nine selected countries (Argentina, Bolivia, Brazil, Colombia, Honduras, Mexico, Paraguay, Peru, and Uruguay). 

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EnglishDocument/Documento
Bagley IP-IDB_cover

Genome Editing in Latin America: CRISPR Patent and Licensing Policy

Type: Discussion document; English
Jul 2021
Author(s): Bagley, Margo

The goal of this discussion document is to provide an overview of the CRISPR plant agriculture patent landscape, as well as to identify and describe key licensing protocols for Latin American companies and institutes interested in engaging in CRISPR plant agricultural research. Part II describes the numbers and locations of CRISPR plant agriculture-related patents being pursued in the Latin American countries of interest for this study (Argentina, Bolivia, Brazil, Colombia, Honduras, Mexico, Paraguay, Peru, Uruguay) as well as the organizations behind the filings. Part III identifies the holders of foundational CRISPR plant agriculture-related patents and describes their general licensing protocols necessary for deploying the technology in the region. The brief concludes by noting that the CRISPR plant agriculture patent landscape is changing rapidly, and it will be incumbent on researchers to regularly assess the need for licenses from other entities.

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EnglishDocument/Documento
IDB Reg Cover ES

Edición génica aplicada a la agricultura: Resumen del marco regulatorio regional

Type: Documento de discusión; español
Jul 2021
Author(s): Kuiken, Todd; Kuzma, Jennifer

Como se señala a lo largo de este documento, muchos países de la región de ALC han establecido marcos regulatorios específicos para la gobernanza de la edición génica, mientras que otros países no han implementado todavía ningún sistema específico, sino que parecen haber incluido estas nuevas tecnologías en los marcos de bioseguridad vigentes para Organismos Genéticamente Modificados (OGMs, u Organismos Vivos Modificados u OVMs). Mientras gran parte de la región de ALC parece unirse en torno a una interpretación similar de cómo se regirá la edición génica, aún no está claro si los tratados internacionales que rigen estas herramientas (por ejemplo, el Protocolo de Cartagena sobre Seguridad de la Biotecnología del Convenio sobre la Diversidad Biológica) decidirán en última instancia y cómo lo harán. Este documento de análisis es un punto de partida para evaluar el panorama de la regulación de la edición génica en ALC, y proporciona una descripción general y amplia del estado de la gobernanza de cultivos OGM y cultivos editados genéticamente en nueve países seleccionados (Argentina, Bolivia, Brasil, Colombia, Honduras, México, Paraguay, Perú, y Uruguay).

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EspañolDocument/Documento
bagley-cover-es

Edición génica aplicada a la agricultura: Politicas de patentes y licencias CRISPR en América Latina

Type: Documento de discusión; español
Jul 2021
Author(s): Bagley, Margo

El objetivo de este documento es proporcionar una descripción general de la coyuntura de las patentes relacionadas con tecnologías CRISPR en el sector agrícola vegetal. Asimismo, se pretende identificar y describir los protocolos de obtención de licencias para empresas y otras entidades latinoamericanas interesadas en desarrollar investigación con tecnologías CRISPR. En la Parte II se detalla la cantidad de patentes, su ubicación, así como a las organizaciones encargadas de emitirlas en los países de interés de este estudio: Argentina, Bolivia, Brasil, Colombia, Honduras, México, Paraguay, Perú y Uruguay. En la Parte III, se identifican a los propietarios de patentes fundacionales, así como sus protocolos generales de licenciamiento para implementar la tecnología en la región. A manera de conclusión, se señala que la coyuntura de patentes vinculadas al uso de tecnologías CRISPR en el sector agrícola vegetal atraviesa un proceso de cambio acelerado y que a los investigadores involucrados les compete evaluar regularmente la necesidad de obtener licencias de otras entidades.

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EspañolDocument/Documento
IDB-title screen-8-24-22-EN

Video: Final Presentation on the NCSU/IDB Gene Editing for the Agriculture in LAC

Type: Presentation; English/Spanish
August 2022
Author(s): Project team

Final results and recommendations from the collaboration between IDB and the GES Center titled “Assessment of the Regulatory and Institutional Framework for Agricultural Gene-editing via CRISPR-based Technologies in Latin America and the Caribbean.” Video recording of the virtual meeting on August 24 from 10-12:30 EST where we:

  • Describe our findings regarding stakeholder interviews, case studies of gene-edited banana and sugarcane, and investment recommendations.
  • Describe our findings including two policy briefs: one about intellectual property in the region and a second summarizing ongoing regulatory developments in the region.

In this technical cooperation, NC State University, IDB, and project partners have completed an in-depth analysis of Latin American national regulatory environments for agricultural biotechnology. We examined the preparedness of regulatory systems to anticipate gene-edited products developed through emerging CRISPR-based systems and evaluated regional investment needs for human and physical capital in the agricultural biotechnology space. Through our research, we developed frameworks to provide contextual guidance for IDB client agencies as they consider the socio-economic competitiveness, and trade implications of regulatory updates. /p>

EnglishVideo
IDB-title screen-8-24-22-ES

Video: Presentación Final del Proyecto NCSU/BID sobre Edición Génica aplicada a la Agricultura en ALC

Type: Video; Español
Aug 2022
Author(s): Equipo del proyecto

Es muy grato para nosotros compartir los resultados finales y las recomendaciones que han surgido del estudio “Evaluación del Marco Regulatorio e Institucional para la Agricultura basada en Edición Génica a través de tecnologías CRISPR en América Latina y el Caribe”, fruto de la colaboración entre el Banco Interamericano de Desarrollo (BID) y el Centro de Ingeniería Genética y Sociedad (GES) de la Universidad Estatal de Carolina del Norte (Raleigh, Estados Unidos). Para más información puede visitar la página web de este proyecto.

Video de la reunión virtual que paso el día 24 de Agosto de 10:00 am a 12:30 EST. En esta reunión abordamos los siguientes temas:

  • Describiremos nuestros hallazgos en base de las entrevistas realizadas con los actores involucrados, estudios del banano y caña de azúcar editados, y recomendaciones de inversión.
  • Describiremos nuestros hallazgos incluyendo dos documentos de análisis de política pública: el primero sobre propiedad intelectual y el segundo sintetizando los avances regulatorios en la región.

Como resultado de esta colaboración, la Universidad Estatal de Carolina del Norte, el BID y  demás colaboradores de este proyecto han culminado un análisis minucioso de los entornos regulatorios vinculados a biotecnología y agricultura de distintos países de América Latina y el Caribe. Examinamos la capacidad de estos sistemas regulatorios de anticipar el desarrollo de productos de edición génica empleando sistemas CRISPR, así como las necesidades que la región tiene en términos de inversión en capital humano e infraestructura en el sector de biotecnología y agricultura. Mediante esta investigación, hemos desarrollado marcos analíticos que proveen orientación contextual para las agencias del BID que están considerando factores que resultan de los avances regulatorios como competitividad socioeconómica e implicaciones en el comercio internacional. 

EspañolVideo
IDB final meeting-Kuzma-thumbnail-8-24-22

Video: Jennifer Kuzma section on Regulatory Landscape and Technical Background

Type: Video; English
Aug 2022
Author(s): Jennifer Kuzma

From the meeting, "Final IDB-NCSU Presentation: Evaluation of regulatory and institutional frameworks for gene editing in agriculture using CRISPR-based technologies in Latin America and the Caribbean"

RECORDED IN ENGLISH

This is the ENGLISH RECORDING of the REGULATORY LANDSCAPE AND TECHNICAL BACKGROUND segment by JENNIFER KUZMA of the virtual meeting held on Wednesday, August 24, 2022 from 10:00 AM - 12:30 PM US ET

Refer to slides 6-15 in the PowerPoint presentation here.

See all videos from this meeting here
EnglishVideo
IDB final meeting-Bagley-thumbnail-8-24-22

Video: Margo Bagley section on Intellectual Property and CRISPR

Type: Video; English
Aug 2022
Author(s): Margo Bagley

From the meeting, "Final IDB-NCSU Presentation: Evaluation of regulatory and institutional frameworks for gene editing in agriculture using CRISPR-based technologies in Latin America and the Caribbean"

This is the ENGLISH RECORDING of the INTELLECTUAL PROPERTY segment by MARGO BAGLEY of the virtual meeting held on Wednesday, August 24, 2022 from 10:00 AM - 12:30 PM US ET

Refer to slides 23-38 in the PowerPoint presentation here.

See all videos from this meeting here
EnglishVideo
IDB Agenda cover image EN 8-24-22

Meeting Agenda: Final IDB-NCSU Presentation

Type: Document; English
August 2022
Author(s): Project Team

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EnglishDocument/Documento
IDB Agenda cover image ES 8-24-22

Agenda: Presentación Final BID-NCSU

Type: Documento; español
Aug 2022
Author(s): Equipo del proyecto

Descarga PDF
EspañolDocument/Documento
IDB-title screen-12-2-21-EN

Video: Interim Progress Update on the NCSU/IDB Regional Gene Editing Project for the Agricultural Sector of LAC

Type: Video, English
Dec 2021
Author(s): Project team

In this virtual meeting held on December 2, 2021, we:

  • Describe our progress including two policy briefs: one about intellectual property in the region (english/spanish) and a second summarizing regulatory developments (english/spanish).
  • *Describe our progress regarding stakeholder interviews and the case study selection process. (separate recording)
See all videos from this meeting here
EnglishVideo
EN_Title slide_Interviews and case studies

Video: Addendum - Stakeholder Interviews and Case Study Selection

Type: Video, English
Dec 2021
Author(s): Project team

Originally intended to be presented at the December 2, 2021 meeting, "Interim Progress Update on the NCSU/IDB Regional Gene Editing Project for the Agricultural Sector of LAC," these sections were recorded separately due to time constraints on the day of the update meeting:

  • See slides 63-80 of the main PowerPoint deck.
  • Presented in English by Mike Jones and Katie Barnhill-Dilling

See all videos from this meeting here
EnglishVideo
IDB-title screen-12-2-21-EN

Video: Actualización de progreso provisional de NCSU/BID Proyecto Regional de Edición Génica para el sector agropecuario de ALyC

Type: Video, español
Dec 2021
Author(s): Equipo del proyecto

En esta reunión virtual en el día Jueves 2 de diciembre de 2021, conversaremos sobre:

  • Nuestros avances en el desarrollo de dos documentos de análisis de políticas públicas: uno sobre propiedad intelectual en la región (inglés/español) y el otro que sintetiza el panorama regulatorio regional (inglés/español).
  • *Nuestros avances en cuanto a las entrevistas con expertos y reguladores de tecnologías CRISPR de la región así como el proceso de selección de nuestro estudio de caso. (Grabado por separado)
Vea todos los videos de esta reunión aquí.
EspañolVideo
IDB-title screen-12-2-21-EN

Video: Suplemento: Entrevistas con partes interesadas y estudios de casos

Type: Video, español
Dec 2021
Author(s): Equipo del proyecto

Originalmente pensada para ser presentada en la reunion del 2 de Dicimebre del 2021 titulada "Avances provisionales sobre el progreso del proyecto regional de edición génica NCSU / BID para el sector agrícola de ALC" estas secciones fueran grabadas de manera separada debido a limitaciones de tiempo en el día de la reunión:

  • Mire las diapositivas 63-80 de la presentacion de PowerPoint
  • Fueron presentadas por Mike Jones en español
Vea todos los videos de esta reunión aquí.
EspañolVideo
IDB-title screen-12-2-21-ES

Video: Atualização de progresso provisório em CRISPR na América Latina e Caribe

Type: Video, Português
Dec 2021
Author(s): Equipe de projeto

Veja todos os vídeos deste encontro aqui.
PortuguêsVideo
PT_Title slide_Interviews and case studies

Video: Suplemento: Entrevistas com as partes interessadas e seleção de estudos de caso

Type: Video, Português
Dec 2021
Author(s): Equipe de projeto

As seções a seguir seriam originalmente apresentadas na Reunião de 02 de Dezembro de 2021 denominada "Atualização sobre o progresso do projeto regional sobre edição de genes para o setor agrícola na América Latina e Caribe da NCSU/IDB". Essas seções foram gravadas em separado devido às limitações de tempo

  • Referente aos slides PowerPoint 63 a 80
  • Apresentado em português por Luciana Ambrozevicus
Veja todos os vídeos deste encontro aqui.
PortuguêsVideo
IDB presentation title slide-EN

Interim Progress Update on the NCSU/IDB Regional Gene Editing Project for the Agricultural Sector of LAC

Type: Presentation; English
Dec 2021
Author(s): Project team

PowerPoint presentation for the virtual meeting held on December 2, 2021, presented by the GES Center and the project team, where we:

  • Describe our progress including two policy briefs: one about intellectual property in the region (english/spanish) and a second summarizing regulatory developments (english/spanish), and
  • Describe our progress regarding stakeholder interviews and the case study selection process (recorded separately)

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EnglishPresentation/Presentación
IDB presentation title slide-ES

Actualización de progreso provisional de NCSU/BID Proyecto Regional de Edición Génica para el sector agropecuario de ALyC

Type: Presentación, español
Dec 2021
Author(s): Equipo del proyecto

Presentación en PowerPoint para la reunión virtual realizada el 2 de diciembre de 2021, presentada por el Centro GES y el equipo del proyecto, donde compartimos:

  • Nuestros avances en el desarrollo de dos documentos de análisis de políticas públicas: uno sobre propiedad intelectual en la región (inglés/español) y el otro que sintetiza el panorama regulatorio regional (inglés/español).
  • Nuestros avances en cuanto a las entrevistas con expertos y reguladores de tecnologías CRISPR de la región así como el proceso de selección de nuestro estudio de caso. (Grabado por separado).

Descarga PDF

EspañolPresentation/Presentación
Nepomuceno IDB EMBRAPA slide 1

Development in gene editing in Brazil and at EMBRAPA

Type: Presentation; English
Dec 2021
Author(s): Alexandre Nepomuceno

PowerPoint slides from Alexandre Nepomuceno, General Head of the Brazilian Soybean Research Center - Embrapa Soja, for the public update meeting held on December 2, 2021, on the development of gene editing in Brazil and at EMBRAPA.

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EnglishPresentation/Presentación
Honduras slide 1

Regulation of Genetically Modified Crops within the Framework of the Customs Union of Honduras and Guatemala

Type: Presentation; English
Dec 2021
Author(s): Roger Orellana

PowerPoint slides from Roger Orellana, President of the Committee for Agricultural Biotechnology and Biosafety (CNBBA) in Honduras, for the public update meeting held on December 2, 2021, focusing on regulation and policy in Honduras and cross-collaboration with Guatemala.

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EnglishPresentation/Presentación
IDB launch slides thumb

Video: Lanzamiento del proyecto - Evaluación del marco regulatorio e institucional de la edición genética en agricultura mediante tecnologías basadas en el CRISPR en América Latina y el Caribe

Type: Video, español
Jan 2021
Author(s): Jones, Michael; Kuiken, Todd

Grabación en video de la reunión en Zoom por el “Evento de lanzamiento del Proyecto Regional de Edición Genética para el sector agrícola de ALC”. 27 enero, 2021.

EspañolVideo
IDB launch slides thumb

Evaluación del marco regulatorio e institucional de la edición genética en agricultura mediante tecnologías basadas en el CRISPR en América Latina y el Caribe

Type: Presentación, español
Jan 2021
Author(s): Jones, Michael; Kuiken, Todd

Diapositivas de PowerPoint del evento de lanzamiento en el 27 enero, 2021.

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EspañolPresentation/Presentación
idb flyer english thumb

Project Flyer: CRISPR in Latin America and the Caribbean

Type: Informational flyer; English
Mar 2021
Author(s): Mulligan, Patti

The Inter-American Development Bank is working with North Carolina State University’s Genetic Engineering and Society (GES) Center in a two-year project to assess the regulatory and institutional frameworks surrounding gene-editing via CRISPR-based technologies in the Latin America and Caribbean (LAC) regions.

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EnglishDocument/Documento
idb flyer spanish thumb

Folleto del proyecto: CRISPR en América Latina y el Caribe

Type: Folleto informativo; español
Mar 2021
Author(s): Mulligan, Patti

El Banco Interamericano de Desarrollo está trabajando con el Centro de Ingeniería Genética y Sociedad (GES) de la Universidad del Estado de Carolina del Norte en un proyecto de dos años para evaluar los marcos regulatorio e institucionales en torno a la edición genética mediante tecnologías basadas en el CRISPR en las regiones de América Latina y el Caribe.

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EspañolDocument/Documento

Additional Resources on Genome Editing

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What is Gene Editing?

The power and promise of gene editing, CRISPR specifically, was first realized with the discovery of CRISPR loci in the 1980s (Anzalone, Koblan, and Liu 2020). Since that time, CRISPR-Cas systems have been further developed enabling genome editing in virtually all organisms across the tree of life (Anzalone, Koblan, and Liu 2020).

Gene editing is not a singular technology or technique; it refers most often to a set of techniques that enable the manipulation of a genome with greater precision than previous iterations of genetic engineering (Shukla-Jones, Friedrichs, and Winickoff 2018b).

They are designed to insert, delete, or alter either one or more DNA nucleotides (Shukla-Jones, Friedrichs, and Winickoff 2018a).

In the last few years, there have been rapid developments of a diverse set of genome editing tools and CRISPR-based technologies that have revolutionized genome manipulation (Kuiken, Barrangou, and Grieger 2021). These developments are democratizing access and enabling a more diverse set of actors to redefine research and development for biotechnology products encompassing food, agriculture, and medicine than has been seen with other emerging technologies (Kuiken, Barrangou, and Grieger 2021). However, these developments are also raising concerns about environmental, cultural and socio-economic risks. Including whether governance systems can keep pace with their rapid developments.

These tools can include but are not limited to:

  • CRISPR/Cas9 – Clustered Regularly Interspaced Short Palindromic Repeats
  • TALEN – Transcription Activator-Like Effector Nucleases
  • ZNF – Zinc-Finger Nucleases
  • ODM – Oligonucleotide Directed Mutagenesis

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Three main types of gene editing

Adapted from (Friedrichs et al. 2019b, 2019a).
*SDN2 or SDN3 donor templates can come from the same or different species (cisgenic or transgenic).

Genome Editing Type

Description

SDN1
(site-directed nuclease 1)
Involves the unguided repair of a targeted double-strand break (DSB) by the mechanism called nonhomologous end joining. The spontaneous repair of this break can lead to a mutation causing gene silencing, gene knock-out or a change in the activity of a gene.
SDN2*
(site-directed nuclease 2)
Involves a template-guided repair of a targeted DSB using a sequence donor, typically short single-stranded DNA. The donor carries one or several small mutations flanked by two sequences matching both ends of the DSB, and is thus recognized as a repair template, allowing the introduction of the mutation(s) at the target site.
SDN3*
(site-directed nuclease 3)
Involves a template-guided repair of a targeted DSB using a sequence donor, typically double-stranded DNA containing an entire gene or an even longer genetic element(s). Both ends of the donor are homologous to the DSB ends (and the donor sequence is usually more than 800 bp each), which therefore recognize the donor as a repair template, allowing the introduction of the gene or genetic element(s)at the target site.

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Overview of genome-editing tools, the possible genetic outcomes in each case, and examples of crop traits generated using these tools

The colored arrows and boxes link published crop trait examples with the associated genome-editing tool and outcome.

Note: Reprinted from Jansing, J. et al. Genome Editing in Agriculture: Technical and Practical Considerations. Int. J. Mol. Sci. 2019, 20, 2888. doi: 10.3390/ijms20122888

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Team

The consultancy team will include experts from agricultural economics, public policy, international law, communications, and biotechnology.  The required deliverables of the project include preliminary, interim, and final reports, country-specific policy briefs for key stakeholder agencies, content to populate an IDB website portal for project dissemination, and a dedicated report on Recommended Strategic IDB Investments in Agricultural Biotechnology.  Three workshops will be held with stakeholders from IDB and focus countries, including a kick-off meeting, first findings presentation, and a final findings presentation (virtual and/or physical, as dictated by COVID-19 status and institutional policies).

Project Head

Gonzalo Muñoz
Gonzalo Muñoz, MA
Senior Rural Development Specialist,  Inter-American Development Bank 
Email: gonzalom@iadb.org

Principal Investigator

Photo of Katie Barnhill-Dilling
Katie Barnhill-Dilling, PhD
Senior Research Scholar, Genetic Engineering and Society Center, NC State University
Email: skbarnhi@ncsu.edu

Principal Investigator

Mike Jones
Michael S. Jones, PhD
Assistant Professor of Economics, University of Alaska Anchorage
Email: msjones6@alaska.edu

Co-Principal Investigator

Jennifer Kuzma
Jennifer Kuzma, PhD
Co-director, Genetic Engineering and Society Center, NC State University
Email: jkuzma@ncsu.edu

Co-Principal Investigator

Zack Brown
Zachary S. Brown, PhD
Associate Professor of Agricultural and Resource Economics, NC State University
Email: zsbrown2@ncsu.edu

Co-Principal Investigator

Luciana Ambrozevicius
Luciana Ambrozevicius, PhD
Independent Consultant, Brazil
Email: lupiambro@gmail.com

Co-Principal Investigator

Margo Bagley
Margo Bagley, JD
Asa Griggs Candler Professor of Law, Emory University School of Law
Email: mbagley@emory.edu

Co-Principal Investigator

Maria Mercedes Roca
Maria Mercedes Roca, PhD
Executive Director, BioScience Think Tank
Email: prof.mariamercedesroca@gmail.com

PhD Student

Photo of Sebastian Zarate
Sebastian Zarate
PhD Student in Forestry and Environmental Resources and AgBioFEWS Fellow
Email: jszarate@ncsu.edu

Project Staff

Patti Mulligan
Patti Mulligan
Communications Director, Genetic Engineering and Society Center, NC State University
Email: phmullig@ncsu.edu

Project Staff

Sharon Stauffer
Sharon Stauffer
Center Program Manager, Genetic Engineering and Society Center, NC State University
Email: sastauff@ncsu.edu

Advisor

Eirivelthon Santos Lima
Eirivelthon Santos Lima, PhD
Former Leading Rural Development Specialist, Inter-American Development Bank

Advisor

Todd Kuiken
Todd Kuiken, PhD
Former Senior Research Scholar, Genetic Engineering and Society Center, NC State University – no longer at NC State

Grupo de Trabjo Ad Hoc (GTA)

Members

Argentina

Sra. Dalia Lewi
Director, National Bioeconomy Directorate
Ministry of Agriculture, Livestock and Fisheries

Brazil

Dr. Alexandre Nepomuceno
General Head - National Soybean Research Center - Embrapa

Colombia

Alberto Alfonso Rosero
Technical Director of Seed Programs - Instituto Colombiano Agropecuario (ICA)

Honduras

Roger Orellana
Head of Seed Certification Department, SENSA

Uruguay

Alejandra Ferenczi
Biosafety Manager, General Directorate of Biosafety and Food Safety
Ministry of Livestock, Agriculture and Fisheries

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Contact Us

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Sponsor

The Inter-American Development Bank works to improve lives in Latin America and the Caribbean. Through financial and technical support for countries working to reduce poverty and inequality, IDB helps improve health and education, and advance infrastructure to achieve development in a sustainable, climate-friendly way. With a history dating back to 1959, today IDB is the leading source of development financing for Latin America and the Caribbean. IDB provides loans, grants, and technical assistance; and conducts extensive research. The Bank’s current focus areas include three development challenges – social inclusion and equality, productivity and innovation, and economic integration – and three cross-cutting issues – gender equality and diversity, climate change and environmental sustainability; and institutional capacity and the rule of law.

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Citations

Anzalone, Andrew V., Luke W. Koblan, and David R. Liu. 2020. “Genome Editing with CRISPR–Cas Nucleases, Base Editors, Transposases and Prime Editors.” Nature Biotechnology 38 (7): 824–44. https://doi.org/10.1038/s41587-020-0561-9

Friedrichs, Steffi, Yoko Takasu, Peter Kearns, Bertrand Dagallier, Ryudai Oshima, Janet Schofield, and Catherine Moreddu. 2019a. “An Overview of Regulatory Approaches to Genome Editing in Agriculture.” Biotechnology Research and Innovation 3 (2): 208–20. https://doi.org/10.1016/j.biori.2019.07.001

Friedrichs, Steffi, Yoko Takasu, Peter Kearns, Bertrand Dagallier, Ryudai Oshima, Janet Schofield, and Catherine Moreddu. 2019b. “Meeting Report of the OECD Conference on ‘Genome Editing: Applications in Agriculture—Implications for Health, Environment and Regulation.’” Transgenic Research 28 (3–4): 419–63. https://doi.org/10.1007/s11248-019-00154-1

Jansing, Julia, Andreas Schiermeyer, Stefan Schillberg, Rainer Fischer, and Luisa Bortesi. 2019. “Genome Editing in Agriculture: Technical and Practical Considerations.” International Journal of Molecular Sciences 20 (12): 2888. https://doi.org/10.3390/ijms20122888

Kuiken, Todd, Rodolphe Barrangou, and Khara Grieger. 2021. “(Broken) Promises of Sustainable Food and Agriculture through New Biotechnologies: The CRISPR Case.” The CRISPR Journal, February, 1–7. https://doi.org/10.1089/crispr.2020.0098

Shukla-Jones, Anu, Steffi Friedrichs, and David E. Winickoff. 2018a. “Gene Editing in an International Context” OECD Scien. https://doi.org/10.1177/0149206304273662

Shukla-Jones, Anu, Steffi Friedrichs, and David E Winickoff. 2018b. “Gene Editing in an International Context: Scientific, Economic and Social Issues across Sectors.” OECD Publishing. https://doi.org/10.1787/18151965

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