FDA Issues Guidance for Foods Made from Genome-Edited Plants

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The practice of altering plant genetics to better suit human needs, dates back thousands of years. What was once done through selective plant breeding – as well as alterations beyond what is possible with selective breeding – is now being done in laboratories with gene editing. New laboratory engineered plant varieties can offer improvements – such as improved nutritional profiles and/or disease resistance, but sometimes genetic engineering can cause unintended consequences or may create unexpected compounds in familiar plants which may create potential health hazards for people or animals. On February 22, 2024, the FDA issued Guidance for Industry: Foods Derived from Plants Produced Using Genome Editing. This Guidance, while not mandatory, offers suggestions to producers as to how the FDA will evaluate whether new plant varieties are safe for human and/or animal consumption. The FDA specified that its regulatory oversight will not depend on the method by which the new plant variety was created, but upon the characteristics of the new plant (including protein profile, nutrient profile, allergen content, etc.). The proposed use of the new variety of plant will also be an important consideration. For example, many animal diets are composed of a very limited number of food sources. If a new proposed plant could constitute a significant portion of the animal’s diet, it will be necessary to consider how alterations in the new plant will impact the animal’s health and the meat, eggs, milk, etc., that the animal produces.

For new plant varieties, the FDA offers two voluntary programs which producers may participate in to evaluate whether their new plant varieties will meet FDA regulations: premarket consultation and premarket meeting.

A premarket consultation is the more fulsome process. It is recommended for genome-edited plants that may raise food safety or regulatory concerns, such as:

• Gene modifications that create a similarity to a known allergen;  
   
• Gene modifications that create significant increases in potentially harmful compounds, including toxins, allergens, and/or substances to which humans or animals may have a sensitivity, such as gluten.   
   
• Gene modifications that create significant alterations in nutritional value, including:   
   
  • Gene modifications that raise nutrient levels meaningfully above that in the traditional version of the plant.   
     
  • Gene modifications that lower nutrient levels meaningfully below that in the traditional version of the plant.   
     
  • Gene modifications that increase nutrient levels to an extent that it raises a safety concern.   
     
  • Gene modifications that add nutrients subject to regulatory limitations.   
     
  • Gene modifications that change the fatty acid profile of the plant.   
     
  • Gene modifications likely to impact the bioavailability of nutrients in the plant.

If the genome-edited plant is to be used in animal feed, all of the same concerns outlined above apply, plus, a premarket consultation would also be appropriate for:

• Gene modifications that have the potential to introduce residues to the meat, milk or eggs produced by animals eating the plant.   
   
• Gene modifications that increase antinutrients (substances that block the absorption of nutrients).   
   
• Gene modifications that could create substances in levels sufficient to disrupt an animal’s digestion.   
   
• Gene modifications that change how the plant is used.   
   
• Gene modifications that change the genetic make-up of the plant by (a) adding new genes and/or genetic elements that do not naturally occur in the plant; or (b) add additional copies of naturally occurring genes.

For genome-edited plants that do not raise the concerns listed above, the FDA recommends a voluntary premarket meeting. The purpose of a premarket meeting is to inform the FDA of foods from genome-edited plants that may enter the market and also to afford the FDA an opportunity to help producers ensure that such foods are safe and legal. The FDA stressed that a premarket meeting is not a substitute for a premarket consultation, in which a higher level of scrutiny is available to assess food safety questions. In addition, if safety and/or regulatory concerns are raised during a premarket meeting, the FDA will expect follow up with the producer to address those concerns.

The FDA also noted that its premarket consultation or meeting is not necessarily the only regulatory concern that the producer of a genome-edited plant may need to address. Plants and their products may also be subject to oversight by the USDA’s Animal and Plant Health Inspection Service, which regulates potential risks to plant health, and the EPA, which regulates the use of pesticides.

So – the message is – if you are producing human or animal food using genome-edited plants, take advantage of a voluntary FDA premarket consultation or meeting to help identify potential health hazards and avoid regulatory problems down the line.