Revisions to USDA biotechnology regulations: The SECURE rule

Abstract

In keeping with the directive in Executive Order 13874 (Modernizing the Regulatory Framework for Agricultural Biotechnology Products) to adopt regulatory approaches that are proportionate to risk and avoid arbitrary distinctions across like products, the US Department of Agriculture (USDA) revised its biotechnology regulations by promulgating the Sustainable, Ecological, Consistent, Uniform, Responsible, and Efficient (SECURE) rule. Specifically, the SECURE rule 1) establishes exemptions for plants modified by genetic engineering where the modification could otherwise have been made through conventional breeding, 2) uses risk posed by the introduced trait to determine whether an organism is regulated, rather than relying on whether the organism was developed using a plant pest, and 3) provides a mechanism for a rapid initial review to efficiently distinguish plants developed using genetic engineering that do not pose plausible pathways to increased plant pest risk from those that do. As a result of the focused oversight on potentially riskier crops developed using genetic engineering, USDA is expected to improve the efficiency and effectiveness of its oversight program. The reduced regulatory burden is expected to promote innovation by expanding the number and diversity of developers to include smaller businesses and academics and to increase the number and variety of traits being developed through biotechnology.

Engineering of Sr33 and Sr50 plant immune receptors to alter recognition specificity and autoactivity

“…The region required for the transfer of effector recognition involved as little as 12 amino acid substitutions within 450 bp. When this region were to be introduced into a closely related homolog through homologous recombination the engineered plants would follow the regulatory exemptions described in the SECURE rule from the USDA, given this variation is already present in the edited plant's gene pool (Hoffman, 2021). The ability to transfer effector recognition between close homologs also gives us the ability to avoid interspecies transfer of genes, which is controversial for some opponents of transgenic plants.…”

Governing gene editing in agriculture and food in the United States

“…In May 2020, the USDA released the final rule for its biotechnology regulations, 7CFR part 340, called SECURE (Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient) rule for plants developed using biotechnology (USDA-APHIS, 2020). While under the Coordinated Framework, regulation of biotechnology in plants was triggered because an agrobacterium was used to introduce foreign DNA into a product, the updated SECURE rule states that plants produced through genetic engineering will only be regulated if they pose a risk (Hoffman, 2021). SECURE will exempt most gene-edited plants from regulation and will allow developers to decide whether their products qualify for these exemptions (Davies and Brasher, 2020;Montenegro, 2020b;Stokstad, 2020).…”

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

“…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 ). However, the longstanding relationship between regulation and the diversification of crop biotechnology development is not well understood empirically.…”

“…Under this framework, the main regulatory trigger for engineered plants was the integration of any sequences derived from plant pest organisms. This included many genes of interest for agronomically relevant traits, as well as Agrobacterium T-DNA sequences used as engineering tools ( Hoffman, 2021 ). To bring a genetically engineered plant to market, developers were required to submit a “Petition for Determination of Nonregulated Status” (PDNS) through the USDA Animal and Plant Health Inspection Service (APHIS).…”

“…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.…”