US Food and Drug Administration warns GMO developers over food allergy risks

The US Food and Drug Administration (FDA), which regulates genetically modified organisms (GMOs) for food safety, has written a letter to manufacturers and developers of new plant varieties who intend to transfer genes for proteins that are food allergens (including allergens from foods identified as major food allergens) into new plant varieties used for food. The FDA cautions these developers to consider the food safety risks posed by such allergens and plan early in development to manage the risks.

What the FDA insists on in the letter is in effect nothing less than complete segregation and traceability for any potentially allergenic GM crop.

FDA’s letter also cautions that if unexpected and unlabelled allergens enter the food supply, this could have other consequences for food producers, such as needing to recall the affected products.

In a strong statement, the FDA states, "We write today to strongly encourage developers of such new plant varieties to talk to us after having carefully considered in the earliest stages of product development the steps that would be necessary to comply with relevant legal requirements and keep materials from their plants segregated from other plants and foods to ensure that allergens are not unintentionally transferred into food. Failure to keep such materials strictly segregated would thwart the most effective way that people with food allergies have to prevent allergic reactions, which is by avoiding foods that contain allergens."

The FDA is, of course, correct. GMWatch has long cautioned about the documented problem of older-style genetic engineering techniques resulting in the production of mutant or novel proteins that could prove toxic or allergenic. We, in common with scientists across the world, have also warned that new GM techniques like gene editing can do the same.

However, there are three major problems with the FDA's stance. 

First, the FDA's "premarket consultation program" for foods from new plant varieties, including GM ones, is entirely voluntary, as the FDA is eager to point out. The developer doesn't have to subject its GMO to the consultation, though as far as we know, all developers of older-style GMOs have done so. This heightens the risk that potential allergens won't be spotted.

Second, the FDA doesn't accept liability for ensuring that the new food is safe to eat: As it states, it is the "developers of new plant varieties containing an unexpected allergen" that "have a responsibility to ensure that the products they market are safe and lawful". 

That's equivalent to allowing a student to mark his own homework. We know that system doesn't work, because the developer of the GMO hornless cattle, Recombinetics, completely failed to spot that the cattle unexpectedly contained bacterial DNA, including antibiotic resistance genes. The rogue DNA was only spotted by FDA scientists who just happened to do their own analysis of the genome.

Third, people can be allergic to just about anything, including foods not commonly viewed as allergenic. We know of adults and children who are allergic to such diverse foods as soy; maize; cumin; various beans, nuts, fruits, and seeds; beetroot; carrots; rice; certain herbs; and even, in the case of some babies, their own mother's milk.

That's only the known allergens. There will be an unknown number of as yet unidentified allergens in the form of the mutant or novel proteins contained in GM foods both old and new. Based on that principle, it's not enough to expect GMO developers to police their use of known allergenic proteins (and it's extremely doubtful that they will do even that much). They would also have to look for unknown allergens. And for that, they'd have to test each mutant and novel protein present in their GMO for allergenicity. 

Do we expect that to happen? Only insofar as one day, a pig might fly or a chimp write a Shakespeare play.

Yet the FDA's strong letter to GMO developers is a welcome reminder of the dangers of new and old GM techniques. And it stands in stark contrast to the UK government's and Food Standards Agency's seeming determination to allow hidden novel "precision bred" GMOs into our fields and food supply without coexistence measures, full consumer-inclusive traceability, and on-package GMO labelling. In this cavalier approach, the UK government and its agencies are in effect gambling with people's lives.

Examples of allergen dangers

In its letter to GMO developers, the FDA cites an example whereby a gene for an allergenic animal protein is transferred into a new plant variety, to provide a non-animal source of the protein for use as an ingredient in another food. As the FDA states, "This could result in the presence of an unexpected allergen in that food."

The FDA says, "Because adverse reactions to food allergens can be severe or even life-threatening, including when the allergen is present at low levels, we think it is important to reach out to manufacturers and developers now, while such plant varieties are still in early research and development stages."

The FDA cites the historical case of a Brazil nut gene that was genetically engineered into a soy variety. In tests, the soybean variety caused an allergic reaction to the soy in people who were allergic to Brazil nuts. As a result, the soy variety was voluntarily discontinued.

Segregation of GMOs necessary to guard against allergic reactions

The FDA warns GMO developers, "If you are developing a plant variety with a transferred gene that encodes a food allergen (which we also refer to as a 'transferred allergen' for brevity), stewardship practices are likely to be more challenging and complicated than with other crops. When considering your proactive risk management plan, you will likely have to significantly bolster standard mitigation strategies and practices (e.g., segregation of crops) to provide the level of food safety assurance necessary to prevent inadvertent mixing of foods containing a transferred allergen with other foods. 

"For example, planting, harvesting, transporting, and storage of seeds and grains from many plant varieties used for food occurs in bulk quantities and requires specialized machinery (e.g., planters, combine harvesters, grain augers, silos). Growers, transporters, processors, food manufacturers, and others in the food production chain responsible for ensuring crop segregation may need to follow special precautions related to seed development and planting, storage of harvested material, and thorough cleaning of machinery at each step sufficient to prevent inadvertent commingling of these new plant varieties and their products with other varieties and products that do not contain the allergen."

The FDA is concerned that "While requiring label declaration for the presence of an allergen is generally FDA’s approach to inform people with food allergies of the presence of an allergen, labelling may be insufficient or inappropriate to address all food allergen safety risks — particularly if, before entering the food supply, these new plant varieties are inadvertently commingled with similar varieties that do not contain the allergen."

Consequently, the FDA says, "Developers would need to ensure that allergenicity information about an allotment of a particular crop containing a transferred allergen remains associated with the allotment through the supply chain (e.g., seed development, planting, harvesting, storage, transport, and processing) in a manner that enables responsible parties to ensure that the allotment is not mistaken for or used as its counterpart food that does not contain the allergen."

Legislation in the UK, US, Canada, Japan, and some other countries means that proper safety testing of new GMOs is not required by regulators. Given that, nothing short of complete segregation of new GMOs from seed to dinner plate and on-package GMO labelling can fulfil the FDA’s aim of protecting the public against risks of allergic and even toxic reactions to new GMOs in food.


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https://gmwatch.org/en/106-news/latest-news/20212

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