Page 48 - Breeding Edge ebook

“They could push the boundaries a little further in terms of deregulating categories of things similar to
things they’ve already seen,” BIO's Nesbitt said. In its comments to the agency on the proposed 340
changes, BIO said, “We believe that there will be many instances in which it is more scientifically

justifiable to assess the regulatory status of whole categories of organisms, such as those of the same
combination of species and trait.”

Greg Jaffe, director of the Project on Biotechnology at the Center

for Science in the Public Interest, said he has been advocating a
“nuanced approach” to regulation. “There should be risk-based
analysis where you’re looking at the different crops, the

different possible gene edited products and putting them into

buckets. Some of those buckets may involve little or no

regulation, and others may involve a full risk assessment and a

mandatory pre-market approval process. It would depend on
what the potential risk profile is for those.”

Paul Schickler, former president of biotech seed giant DuPont

Pioneer, has cautioned the biotech industry against using gene Greg Jaffe, CSPI
editing to avoid regulation. Speaking at The World Food Prize’s

Borlaug Dialogue in 2017, he said, “If we do position gene editing as an end-around of regulatory
systems, it will be the failure of gene editing as a technology.”

But clearly, something has to give on the regulatory front if researchers and investors are going to
advance both plant and animal agriculture.

FDA has approved one genetically engineered animal for food use: AquAdvantage salmon, genetically
engineered by AquaBounty to grow much faster than non-GE farm-raised Atlantic salmon. But it took
20 years for that process to play out, “so that’s not a working regulatory system,” Nesbitt said. And the
salmon have yet to be sold in the U.S. because of barriers imposed by Alaskan lawmakers.

“All kinds of animal companies are working in the space, but there’s just not a clear path
forward, and clearly the process at FDA is not working,” he said.

FDA says the regulatory process it went through with AquAdvantage salmon does not necessarily
provide lessons for future animal applications.

In response to questions posed by Agri-Pulse, FDA said, “Application of the regulations to individual
products is highly case-specific so the experience with one application, such as the one for the GE
salmon, may not be relevant to other applications.”

But Karen Batra, a BIO spokesperson, says that “A lot of our member companies are looking to
that as kind of the model. They’re saying, "Well, I’m going to go to Brazil, I’m going to go away
from this regulatory system. I’m not going through what (AquaBounty) went through.'”

Nesbitt adds, “For those things where there’s not a clear path to market, they just won’t even invest in
the research in the first place, so until we have these clear paths, a lot of these companies won’t even be
investing in this space.”

J.R. Simplot Co. also commented on the chilling effect that the draft FDA guidance could have on new
opportunities for agriculture.

46 www.Agri-Pulse.com