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The practice of altering plant genetics to better suit human needs, dates back thousands of years. But what once took place through selective plant is now being happening in laboratories through gene editing.
We can thank laboratory engineered plant varieties for improvements such as increased nutritional profiles and disease resistance but, on the flipside, sometimes genetic engineering can cause unintended consequences or even create unexpected compounds in familiar plants, creating potential health hazards for people or animals.
Earlier this year, the FDA issued a document titled “Guidance for Industry: Foods Derived from Plants Produced Using Genome Editing.”
While it’s not mandatory, this Guidance does offer suggestions to producers outlining 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.
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 byproducts the animal produces.
For new plant varieties, the FDA offers two voluntary programs for producers 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, or modifications that create significant alterations in nutritional value, among others.
For genome-edited plants that do not raise these concerns, or any of the other concerns mentioned at the link in our show notes, the FDA recommends a voluntary premarket meeting. The purpose of this meeting is to inform the FDA of foods from genome-edited plants that may enter the market and also afford the FDA an opportunity to help producers ensure that such foods are safe and legal.
That having been said, the FDA stressed that a premarket meeting is not a substitute for a premarket consultation, which offers a higher level of scrutiny 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.
It’s also important for producers to note that the premarket consultation or meeting is not necessarily the only regulatory concern that they 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.
Thank you for listening to Womble Perspectives. If you want to learn more about the topics discussed in this episode, please visit The Show Notes, where you can find links to related resources mentioned today. The Show Notes also have more information about our attorneys who provided today's insights, including ways to reach out to them.
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