Finding SECURE Ground: USDA Edits the Biotechnology Regulatory Framework

Barrangou, Rodolphe

doi:10.1089/crispr.2020.29096.rba

Cited by 6 publications

(7 citation statements)

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“…However, depending on the traits of gene edited crops they may be subject to regulation through the Environmental Protection Agency (EPA) and /or the Food and Drug Administration (FDA). Recently in 2020, the SECURE (sustainable, ecological, consistent, uniform, responsible, efficient) platform was developed to streamline and update biotechnology approval in the US (Barrangou, 2020).…”

Section: Regulation Of Genome Editingmentioning

confidence: 99%

Advanced domestication: harnessing the precision of gene editing in crop breeding

Lyzenga

Pozniak

Kagale

2021

Plant Biotechnology Journal

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Summary Human population growth has increased the demand for food crops, animal feed, biofuel and biomaterials, all the while climate change is impacting environmental growth conditions. There is an urgent need to develop crop varieties which tolerate adverse growth conditions while requiring fewer inputs. Plant breeding is critical to global food security and, while it has benefited from modern technologies, it remains constrained by a lack of valuable genetic diversity, linkage drag, and an effective way to combine multiple favourable alleles for complex traits. CRISPR/Cas technology has transformed genome editing across biological systems and promises to transform agriculture with its high precision, ease of design, multiplexing ability and low cost. We discuss the integration of CRISPR/Cas‐based gene editing into crop breeding to advance domestication and refine inbred crop varieties for various applications and growth environments. We highlight the use of CRISPR/Cas‐based gene editing to fix desirable allelic variants, generate novel alleles, break deleterious genetic linkages, support pre‐breeding and for introgression of favourable loci into elite lines.

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Section: Regulation Of Genome Editingmentioning

confidence: 99%

Advanced domestication: harnessing the precision of gene editing in crop breeding

Lyzenga

Pozniak

Kagale

2021

Plant Biotechnology Journal

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“…Regulation of next-generation crops in the United States promises to diversify innovation in agricultural biotechnology. Similar to how CRISPR-Cas and other gene editing methods have been lauded for driving diverse innovations in crop biotech development ( Ahmar et al, 2020 ; Gupta & Shukla, 2017 ; Arora & Narula, 2017 ; Nasti & Voytas, 2021 ; Gao, 2021 ), the new USDA SECURE rule has been framed as enhancing the capacity to bring diverse innovations to market ( Hoffman, 2021 ; Barrangou, 2020 ; USDA APHIS, 2020a ). Specifically, some have argued that SECURE will expand the number of products eligible for exemption ( Davies and Basher, 2020 ; Stokstad, 2020 ), which will increase opportunities for resource limited developers to commercialize their products and contribute to the variety of traits being developed through biotechnology ( Hoffman, 2021 ).…”

Section: Introductionmentioning

confidence: 99%

“…APHIS frames the new SECURE rule as “reducing the regulatory burden for developers,” ( USDA APHIS, 2020b , pg 29790) because it creates expanded categories of exemptions and reforms the review process to proceed in an expedited fashion (in some cases). Some scholars have argued that this will promote diversification ( Hoffman, 2021 ) and democratization ( Barrangou, 2020 ) of crop biotechnology, in part because of a greater capacity to efficiently move products through regulatory review. However, authors have also pointed to problems with SECURE self-exemption rules and non-disclosure norms.…”

Section: Introductionmentioning

confidence: 99%

“…It’s not clear from prior analyses how SECURE will affect the diversification of crop biotech, nor how these trends compare to what has happened under past regulatory regimes. As cited above, analyses of SECURE have applauded the revamping of safety standards to enhance commercialization ( Barrangou, 2020 ; Hoffman, 2021 ) and critiqued some of the socioeconomic implications of these new rules ( Kuzma and Greiger, 2020 ; Jaffe, 2020 ). However, discussions around the past and future of crop biotechnology regulation—especially around SECURE—are largely grounded in conceptual and theoretical analyses.…”

Section: Introductionmentioning

confidence: 99%

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Lessons for a SECURE Future: Evaluating Diversity in Crop Biotechnology Across Regulatory Regimes

George

Hornstein

Clower

et al. 2022

Front. Bioeng. Biotechnol.

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Regulation of next-generation crops in the United States under the newly implemented “SECURE” rule promises to diversify innovation in agricultural biotechnology. Specifically, SECURE promises to expand the number of products eligible for regulatory exemption, which proponents theorize will increase the variety of traits, genes, organisms, and developers involved in developing crop biotechnology. However, few data-driven studies have looked back at the history of crop biotechnology to understand how specific regulatory pathways have affected diversity in crop biotechnology and how those patterns might change over time. In this article, we draw upon 30 years of regulatory submission data to 1) understand historical diversification trends across the landscape and history of past crop biotechnology regulatory pathways and 2) forecast how the new SECURE regulations might affect future diversification trends. Our goal is to apply an empirical approach to exploring the relationship between regulation and diversity in crop biotechnology and provide a basis for future data-driven analysis of regulatory outcomes. Based on our analysis, we suggest that diversity in crop biotechnology does not follow a single trajectory dictated by the shifts in regulation, and outcomes of SECURE might be more varied and restrictive despite the revamped exemption categories. In addition, the concept of confidential business information and its relationship to past and future biotechnology regulation is reviewed in light of our analysis.

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“…Several letters of inquiries have been received for gene-edited crops/organisms, including tomato, citrus, pennycress, soybean, sugarcane, camelina, petunia, flax, rice, and orchid—all of which received the regulatory waiver. Similarly, in May 2020, an updated biotechnology framework has been developed by USDA-APHIS and has been defined as SECURE (Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient) rule [ 197 ]. The framework provides three exemptions to make a single genetic modification to any plant species: (i) changes resulting after DSB in DNA in absence of an external repair template, (ii) targeted single base pair substitution, and (iii) introduction of a known gene that exists in the plant’s gene pool [ 198 ].…”

Section: Introductionmentioning

confidence: 99%

Improving Horticultural Crops via CRISPR/Cas9: Current Successes and Prospects

Bhatta

Malla²

2020

Plants

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Horticultural crops include a diverse array of crops comprising fruits, vegetables, nuts, flowers, aromatic and medicinal plants. They provide nutritional, medicinal, and aesthetic benefits to mankind. However, these crops undergo many biotic (e.g., diseases, pests) and abiotic stresses (e.g., drought, salinity). Conventional breeding strategies to improve traits in crops involve the use of a series of backcrossing and selection for introgression of a beneficial trait into elite germplasm, which is time and resource consuming. Recent new plant breeding tools such as clustered regularly interspaced short palindromic repeats (CRISPR) /CRISPR-associated protein-9 (Cas9) technique have the potential to be rapid, cost-effective, and precise tools for crop improvement. In this review article, we explore the CRISPR/Cas9 technology, its history, classification, general applications, specific uses in horticultural crops, challenges, existing resources, associated regulatory aspects, and the way forward.

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Finding SECURE Ground: USDA Edits the Biotechnology Regulatory Framework

Cited by 6 publications

References 0 publications

Advanced domestication: harnessing the precision of gene editing in crop breeding

Advanced domestication: harnessing the precision of gene editing in crop breeding

Lessons for a SECURE Future: Evaluating Diversity in Crop Biotechnology Across Regulatory Regimes

Improving Horticultural Crops via CRISPR/Cas9: Current Successes and Prospects

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