MAIZALL SUBMISSION TO UK CONSULTATION ON GENE EDITING

MAIZALL has formally submitted comments to the UK government consultation on gene editing, asserting that regulations should be based on sound science. Following the end of the Brexit transition period on December 31, 2020, the UK launched this consultation on January 7 2021, indicating that it is considering the introduction of a different regulatory approach. The European Court of Justice ruled in 2018 that gene-editing techniques are considered GMOs under EU legislation and the UK inherited this jurisprudence when it left the EU.

MAIZALL believes that sound science must determine all regulation on new food agricultural technologies and production techniques. That approach will ensure that farmers have access to the best and most innovative tools, and consumers will be confident that responsible and proper care is taken to ensure the production of safe and quality food. Such measures are also critical for ensuring food security globally and the use of ever more sustainable farming practices. All forms of plant breeding (traditional, organic, GMOs, gene-edited) will be critical to meeting the challenges of producing enough food for a growing world population, with no one method taking precedence over another.

The technologies used for GMOs and gene editing are different. Whereas in the case of GMOs a foreign gene is inserted into the host plant, in gene editing an existing gene is edited or deleted. As a result, the plant is changed but the outcome is indistinguishable from what is achieved through traditional plant breeding or natural selection or genetic change techniques. As such, MAIZALL believes that gene edited crops should be regulated in the same way as traditional plant breeding techniques which can take ten years and more to cross plants and select a suitable and stable variety. Through the use of gene editing, plant selection can be carried out more accurately and faster, thus providing farmers with much needed plant varieties in a shorter timeframe with gene edited crops providing improved characteristics (for example, drought resistant maize varieties).

The three countries represented in MAIZALL all apply a ‘light’ regulatory approach to gene editing. In Argentina and Brazil, a technology company wishing to commercialize a gene edited plant must request an opinion from their government’s agriculture department on a case-by-case basis as to whether or not it constitutes a new combination of genetic material. If that is not the case, the company is not required to make an application for an authorization through their countries’ GMO regulatory procedure. In 2020, the U.S. Department of Agriculture finalized a rule (the SECURE rule) which exempts (i.e., does not regulate) gene-edited plants from existing United States GMO regulations. Developers can request a confirmation from the USDA’s Animal and Plant Health Inspection Service (APHIS) that an edited modified plant qualifies for an exemption and is not subject to the GMO regulations. APHIS will provide a written confirmation of the plant’s status within 120 days.

In 2018, thirteen nations, including Argentina, Brazil, Australia, Canada, Japan and the US, issued a joint statement at the WTO supporting agricultural applications of precision biotechnology, stating that governments should “avoid arbitrary and unjustifiable distinctions between end products (crop traits) derived from precision biotechnology and similar end products, obtained through other production methods.” MAIZALL supported that statement.

The vast majority of countries in the world have adopted, or are in the process of adopting, a ‘light’ regulatory approach to gene editing, including Canada, Australia, Argentina, Brazil, the U.S., Japan, Nigeria and Kenya. Please see this link for the regulatory status around the world: https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/

Please see the following links to the applicable regulations in the MAIZALL countries: Argentina: https://www.boletinoficial.gob.ar/detalleAviso/primera/240529/20210208 Brazil: http://ctnbio.mctic.gov.br/en/resolucoes-normativasjaneiro-de-2018 U.S.: https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/biotech-rule-revision