The US Food and Drug Administration (FDA) has issued an open letter warning start-ups in the emerging field of molecular farming that expressing animal proteins such as egg and dairy proteins in genetically engineered crops such as soybeans will require strict allergen management.
Animal proteins used to be made exclusively by animals. However, new technology has enabled the production of egg, dairy and meat proteins in microbes (precision fermentation), plants (molecular farming), and cultured animal cells (cultivated meat/dairy), which are seen as a more sustainable and ethical alternative to traditional animal agriculture.
The FDA is concerned that the presence of major allergens in products that would not traditionally contain them could pose a risk to people with food allergies. The agency is urging start-ups to take steps now to ensure that their products are properly labelled and that they take action to prevent cross-contact with other foods that would alter the major allergen composition of either product.
The FDA’s open letter warns: “If you are developing a plant variety with a transferred gene that encodes a food allergen… stewardship practices are likely to be more challenging and complicated than with other crops.” On-going, supply chain-wide segregation of crops and crop products with a transferred allergen will require greater risk mitigation strategies and practices than the current standard practice.
They included an example of a developer who genetically modified soybean to contain a Brazil nut protein to alter the nutritional profile. However, upon learning of the allergen risks, the developers voluntarily discontinued development of the new variety. Even though they intended the product only for use in animal feed, they could not ensure the modified soybean would not inadvertently get into human food where it would pose a hazard to those with Brazil nut allergy.
The FDA says it is committed to working with start-ups to ensure that the development of new molecular farming products is done in a safe and responsible manner.