GLOBAL – The Food and Agriculture Organization (FAO) has reviewed food safety issues related to gene editing and offered some key considerations for developing and implementing policies and regulatory criteria for products derived from gene editing. 

Gene (or genome) editing is an umbrella term for various techniques based on molecular biology used for introducing targeted changes in the genome of living organisms.

These techniques are used for numerous reasons including to breed new plant varieties, animal breeds, and microbial strains for agricultural purposes.

They can potentially develop diverse traits to increase food production and quality, as well as contribute towards sustainability and climate change resilience.

While it is not essential to create a brand new set of regulations for gene editing and food safety, says FAO, many countries have found a way to include gene-edited foods in an existing regulatory category to manage such issues.

According to the evaluation, regulators handled gene-edited organisms and the food made from them in the same manner they handled novel foods, GMOs, or traditional goods. Some nations demand that each product be examined on an individual basis.

As stated by FAO, it is preferable to refrain from enforcing rules and regulations on procedures and production techniques that have no bearing on the safety of the final product.

“Including onerous requirements in the regulatory frameworks without a scientific basis should be avoided, otherwise the implementation of such regulations can become a burdensome compliance issue rather than the ultimate objective of consumer protection,” FAO says.

An examination of the Codex recommendations revealed that current procedures, including food safety risk analysis and instructions on food safety assessment procedures, can be modified and used in the safety assessment of foods that have undergone gene editing.

According to FAO, the potential consequences of gene editing on food quality, trade, and safety should not differ significantly from those already present in foods as a result of conventional breeding practices.

FAO has published a specific training tool for conducting a safety assessment of foods derived from recombinant DNA entitled “GM Food Safety Assessment: tools for trainers” (FAO, 2009).

Regulatory frameworks

The Genetic Technology (Precision Breeding) Act, which regulates precision-bred plants and animals, was recently approved in England.

Utilizing technologies like gene editing, and precision breeding modifies the genetic makeup of organisms. The laws governing genetically modified organisms (GMOs) are still more stringent.

The goal is to assist farmers in producing crops that are resistant to disease and drought, cut back on the usage of fertilizers and pesticides, and produce animals that are disease-resistant.

“The ability to use gene editing to make precise, targeted changes to the genetic code of organisms, in a way that can mimic traditional breeding, enables the development of new crop varieties that are more resistant to pests, healthier to eat, and more resilient to drought and heat as climate changes,” said Gideon Henderson, Chief Scientific Adviser, Defra.

The act exempts precision-bred products from labeling regulations. A risk assessment for food and feed produced by precision breeding will be created by the Food Standards Agency (FSA) in consultation with stakeholders.

Precision breeding is one of the New Genomic Techniques (NGTs) that the European Commission is developing a new regulatory framework for.

The Welsh and Scottish governments oppose the use of precision breeding in agriculture. However, the UK Internal Market Act permits the sale of food made in England using these techniques in Scotland and Wales.

Nigeria amended the National Biosafety Management Agency (NBMA) Act to include emerging agricultural biotechnologies in 2019.

Subsequently, in 2020 the NBMA published detailed guidelines for gene editing regulations in particular. When the gene-edited product does not have a novel combination of genetic material, a non-GMO regulatory classification is applied.

In China, the Ministry of Agriculture and Rural Affairs (MARA) issued guidelines for the safety evaluation of genetically engineered plants for agricultural use last year. These guidelines apply gene-edited plants on which no exogenous genes were introduced, with differential treatments according to risk levels.

In the same year, the National Biosafety Authority (NBA) of Kenya also issued guidelines for determining the regulatory process of genome-edited organisms and products, following stakeholder consultations.

The Colombian Agricultural Institute (ICA) allowed the growing of rice that is resistant to the bacterial blight disease in 2020, and a gene-edited high oleic soy was released in the United States in 2019.

Several products are being created, including wheat that is gluten-free, pigs that are resistant to African Swine Fever, cassava that has less cyanide, and bananas that are virus-resistant.

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