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NCBiotech Speakers Debate Gene-Edited Plant Regulation

By Allan Maurer, NCBiotech Writer

“They call us the food police.”

That’s how Greg Jaffe described his work as director of biotechnology for the Center for Science in the Public Interest (CSPI), speaking at the North Carolina Biotechnology Center’s seventh annual Biotech Roundtable.

Unlike most speakers at the event, Jaffe said the U.S. government’s decision not to regulate some products created by gene editing is questionable.

The government’s current position is that gene edited crops such as the non-browning CRISPR mushroom, with no genetic material inserted into the plant’s genome, does not need to be regulated.

But, Jaffe pointed out, “They (the government) didn’t say it was safe. They said they didn’t have the authority to regulate it. It wasn’t a science-based decision.”

The forum, focused on gene editing, was held in conjunction with the Council for Agricultural Science and Technology (CAST) Annual Board Meeting, and hosted this year by the American Agricultural Law Association (AALA) and NCBiotech.

While scientists at the event maintained that CRISPR gene-edited products are indistinguishable from natural plants and shouldn’t be regulated, Jaffe said the impact of that is “No oversight of field trials, no knowledge of what’s in the market.”

If the gene-edited plant is “novel enough to patent, is there a contradiction in calling it natural?” Jaffe asked. “Regulation is not necessarily a dirty word. It can take many forms. Maybe it just requires notification of a gene change.” Oversight should be “science- and risk-based,” he said.

“Is there potential risk? That’s a better discussion than if the product fits some existing legal structure. Not all gene editing is the same.”

A single nucleotide change, which is easy to accomplish with the CRISPR technology, does not appear to present a risk, he added. “But changing 25 or 30 or 60 genes could have a cumulative effect we might want to look at.”

Jaffe said, “We need some standard definitions and harmonization. What happens if gene-edited products are not regulated in the U.S., but are in China?”

What is important to consumers is “Safety, safety, safety,” and the question is “Who ensures it?” he said.

He suggested, “We need some sort of notification system or a national registry for commercial gene-edited products. The information needs to be available to consumers. The food chain needs to know if you are using or selling gene-edited products.”

The only actual regulator at the event, Michael Firko, Animal and Plant Health Inspection Service (APHIS) deputy administrator with the U.S. Department of Agriculture, explained the criteria the USDA uses to decide if a gene-edited plant should be regulated.

Basically, three triggers would lead to regulation: if a new plant used a plant pest as a vector shuttling genetic material into it; or used a plant pest as a donor, via inserted bacterial genes; or is the thing actually a plant pest?

“The question we ask,” he said, “is did you turn the plant into a pest?” So far, he added, “We have never encountered a situation in which someone created a plant that was a plant pest.”

Congress never wrote any laws to let anyone regulate gene-edited plants, he said, and so far, the USDA has not found it necessary to regulate any gene-edited products.

Keith Matthews, counsel at Wiley Rein, who was previously with the Environmental Protection Agency for 17 years and is now in private practice, noted during the panel discussion, that “governments all over the world are struggling with the regulatory status of gene-edited organisms.”

The Federal Food and Drug Administration did publish two public notices in January asking for guidance on gene-editing technology, he said.

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