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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
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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English
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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English
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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English
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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Español
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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Español
IDB launch slides thumb

Video: 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.

Español

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).

Principal Investigator

Todd Kuiken
Todd Kuiken, PhD
Senior Research Scholar, Genetic Engineering and Society Center, NC State University
Email: tkuiken@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

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

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

Project Co-Head

Gonzalo Muñoz
Gonzalo Muñoz, MA
Senior Rural Development Specialist,  Inter-American Development Bank 

Email: gonzalom@iadb.org

Advisor

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

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

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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