Gene Editing Vs. Biotechnology in U.S. Regulations

The U.S. Department of Agriculture this month opened the public comment period on the proposed rule to establish the National Bioengineered Food Disclosure Standard mandated by Congress in 2016. The standard will provide a uniform way to offer meaningful disclosure for consumers who want more information about their food and avoid a patchwork system of state or private labels that could be confusing for consumers and would likely drive up food costs.

This disclosure standard is another paragraph in the long dialogue on bioengineering, which has in the past included discussions on gene editing and biotechnology.

Jane DeMarchi is the Vice President for Government and Regulatory Affairs with the American Seed Trade Association (ASTA). She said regulations for biotechnology and could also affect regulations on gene editing. The USDA issued a statement recently on its intentions for gene editing.

“What that statement clarified was that most applications of gene editing, where you essentially could reach the same end point through gene editing as you would through traditional plant breeding, they don’t see any additional risks and don’t see a need for additional premarket regulations,” DeMarchi explained. “So, what they’re really saying is that gene editing and many applications of gene editing are not biotechnology within their current understanding of their rules for biotechnology.”

The statement read in part:

Under its biotechnology regulations, USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests. This includes a set of new techniques that are increasingly being used by plant breeders to produce new plant varieties that are indistinguishable from those developed through traditional breeding methods. The newest of these methods, such as genome editing, expand traditional plant breeding tools because they can introduce new plant traits more quickly and precisely, potentially saving years or even decades in bringing needed new varieties to farmers.

“With this approach, USDA seeks to allow innovation when there is no risk present,” said Secretary Sonny Perdue. “At the same time, I want to be clear to consumers that we will not be stepping away from our regulatory responsibilities. While these crops do not require regulatory oversight, we do have an important role to play in protecting plant health by evaluating products developed using modern biotechnology. This is a role USDA has played for more than 30 years, and one I will continue to take very seriously, as we work to modernize our technology-focused regulations.”

DeMarchi said ASTA agrees with the statement.

“It’s not a new regulation. It clarifies what their existing regulations are, and it sends a strong signal to the international community about where the United States stands,” she said.  She said ASTA has always thought of the topic of regulations for gene editing as a global issue. “It’s critical to us that the global regulatory system works so products and seeds can be moved internationally. So, we’re looking for countries around the globe to reach the same conclusions that the USDA has.”

DeMarchi pointed out ASTA’s position is not that there is anything wrong with biotechnology, but rather that there should be a distinction between bioengineering and gene editing when it comes to the regulatory process.

“The current regulatory framework at USDA really is trying to make a distinction: Is this a novel characteristic that we haven’t seen before or can’t appear in nature, or is a potential plant pest? That’s what the USDA regulatory system is looking at,” she said. “What the statement that USDA put out is saying is when we look at gene editing, we don’t think those are novel characteristics or potential plant pests and therefore we do not in most cases need to have an additional premarket review.”

However, she explained there will still be regulatory processes.

“Of course, they always have regulation over all plants. The same with FDA, has regulatory authority over all food,” DeMarchi said. “So, they will always reserve the right to make a determination that something does need a premarket review because of whatever they determine.”

A key point for ASTA is the fact that premarket reviews can be extremely long and expensive.

“That is really what has been of concern to us,” she explained. “This is a tremendous tool. Gene editing and the CRISPR technology, if it goes through the current premarket system, those are processes that take 10 to 12 years. They cost over $100,000,000 and that would really be a limiting factor on being able to have the fruits of that innovation be realized. Really, only in a few companies and a few crops can you make that kind of an investment in that kind of a review.”

“FDA did put out a request for information on how they should look at gene editing,” she continued. “Our response to them for that request was to say that they have the current regulatory system in place that they can use for gene editing as well. And in most of those cases, if it is not a new characteristic, it’s not more toxic or produces more allergies, then in most cases it shouldn’t need to go through a regulatory review.”

DeMarchi said there are many things ASTA is anticipating when it comes to these developments.

“One of the things that we’re most excited about is the range of crops that can use gene editing and also some of the potential characteristics that will be reached with gene editing. Disease resistance is, of course, very important to growers and we see a lot of opportunities there,” she said. “We see a lot of opportunities in things like vegetables and trees, again things that have not had access to biotechnology traditionally.”

She said there are also aspects outside the farm.

“I think looking beyond the farmer, one of the things we’re very excited about is consumer attributes (such as) better nutrition, better flavors, products that maybe take fewer inputs and improve the sustainability profile for various crops,” she said. “We know that those things are very important to consumers and we hope to see more of those characteristics being brought to the market.”


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