UPDATE: USDA decides first CRISPR-edited crop is not regulated

UPDATED: The comments below were initially collected when Scientific American reported in February 2016 that USDA were considering whether they would regulate a mushroom which has been gene-edited to prevent browning . USDA said they do not consider the mushroom to be regulated in a letter to Yinong Yang, the Penn State professor who developed the mushroom, making it the first crop modified using CRISPR-Cas9 that USDA has said is not regulated.

(The comments below do not reflect USDA’s decision not to regulate the mushroom.)


Dr. Joyce Van Eck, Assistant Professor, Boyce Thompson Institute (webpage):

Expertise: Biotechnological approaches to the study of gene function and crop improvement. Dr. Van Eck has used CRISPR in her research on tomatoes.

“For my research field, CRISPR is more of a research tool than a method for developing a product. But those people using CRISPR for product development will be waiting for the first product to go through regulation to see what the constraints are. If USDA decides the first product does not require regulation, that would definitely be encouraging for the many people already using CRISPR.

“If you look at industry, they are not holding off using gene-editing for regulatory reasons, they are just getting on with it. Gene-editing is a powerful tool, it’s going to let researchers achieve what they want in a more direct and precise way. For the people I know in research groups, regulatory approval is not the main constraint because the feeling is that CRISPR will have to be viewed differently.

“The regulation of gene-edited crops is a work in progress right now. In the US, regulation of genetically engineered crops by USDA occurs in part due to the method of using of agrobacterium to transfer DNA. Agrobacterium can also be used with CRISPR gene-editing, although the final product may not necessarily contain foreign DNA. There is still a lot to be considered and technology has moved faster than the regulatory aspect has.

“In Canada, regulation is based on what the end product is, unlike in the US where regulation is based on the process used to make the product. If the US moves away from looking at the process and simply regulates on the product, then there would inevitably be less paperwork. That would definitely have an impact on publicly funded research as you wouldn’t have to go through all the costs that are associated with de-regulation.”


Dr. Alan Bennett, Distinguished Professor of Plant Sciences, University of California, Davis (webpage):

Expertise: Molecular biology of tomato fruit development and ripening; intellectual property rights in agriculture. Dr Bennett coauthored a letter in Nature Biotechnology ‘Genetically engineered crops that fly under the US regulatory radar’.

“The report with mushrooms from Penn State is very interesting and demonstrates the speed and power of genome editing technology to modify endogenous plant genes.  The current USDA regulatory framework relies on the potential presence of plant pathogens or plant pathogen DNA and so these modified mushrooms may be determined to be ‘non-regulated’ under the current framework.  However, this determination is not automatic for any genome-edited crop plant but will depend on the specific processes used and the changes that have been made.

“The USDA regulatory framework for genetically modified crops is obsolete and is currently under review.  A regulatory framework that is science-based may well conclude that certain types of genome edited crop plants should not require regulatory oversight – but the floodgates are not opening yet.”


Dr. Rodolphe Barrangou, Associate Professor of Food Science, North Carolina State University (webpage):

Expertise: The biology and genetics of CRISPR-Cas immune systems in bacteria. Applications in industrially relevant organisms for food and biotechnology.

“It’s my understanding, though I can’t be certain, that this is the first time that a CRISPR based gene-edited food product has been put forward for regulatory consideration. My take on this is that, although CRISPR based gene-editing as a technology is novel, and the non-browning mushrooms are a great application, the concept of applying gene-editing tools to foods is not a first.

“CRISPR is impactful as a technology and has democratized gene-editing. It enables a lot of people to do a lot of things quickly and affordably, and has enabled the gene-editing revolution on a broad scale. But the dialogue about GMO food, and about the application of gene-editing in food, is not new. 

“The mushroom is likely to be the first of an ongoing pipeline. I would be surprised if the number of labs looking to develop CRISPR food products wasn’t well into the hundreds. Everyone I talk to who is doing any genetics research is using CRISPR. The first instance is always compelling, but in six months the number will be much higher. 

“If USDA decide a CRISPR edited food does not fall under their purview it will surely accelerate development. Nonetheless, you still need the money and the resources to do the research, and there are many other factors in play, such as consumer perception. It’s a complex picture, but it appears that many things are going in the right direction for CRISPR edited products to enter the marketplace.

“It would behoove the food and agriculture industry to consider that there are many different applications of CRISPR technologies. CRISPR based gene-editing is a compelling application that is getting the bulk of the interest in the media and elsewhere, but there are ways to harness CRISPR that are more ‘natural’. CRISPR has already been used in its natural setting within the bacterial immune system as a fermentation aid in the dairy industry. It has been used on a large scale for about 5 years in the manufacture of both yoghurt and cheese. In fact, the first paper from 2007 that demonstrated what CRISPR does concerned a food based culture.”


Declared interests (see GENeS register of interests policy):

Dr. Rodolphe Barrangou is an inventor on patents related to the use of
CRISPR, is a member of the board of directors of Caribou
Biosciences and is co-founder of Intellia Therapeutics.

No further interests declared.



New Gene-Editing Techniques Could Transform Food Crops–or Die On the Vine‘ published by Scientific American on Wednesday 17 February, 2016.

Letter from USDA to Yinong Yang:

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  • roadwarrior

    Excellent news, can’t wait to see what improvements they make to reduce food waste and boost nutrition.