FDA approves first GE food animal for U.S. consumers

Genetically-engineered salmon approved by FDA. How will it impact U.S. consumers?

On Thanksgiving Eve, the Food and Drug Administration announced approval for the first genetically-modified food animal allowed for U.S. consumers.

That news was welcomed by https://aquabounty.com/AquaBounty, the company that had sought such approval for its GM Atlantic salmon for years. Several days later, Ron Stotish, the company’s CEO and president, spoke with Delta Farm Press. Among his comments:

A recap and timeline on the salmon’s approval…

“It’s been a long road. The fish line was actually established in 1989. Once we had the first fish we’ve basically bred it using conventional breeding for, now, over 12 generations.

“At the time we started this there was no pathway in the United States – or anywhere else – for approval of a genetically modified animal. It wasn’t until 2009 that the FDA put out a guidance document (‘Guidance 187’) which said how they’d regulate this sort of an application.

“AquaBounty opened an INAD (Investigation New Animal Drug) file in 1995. They conducted studies they assumed would be required and those were pretty straightforward. You look at safety to the animal, safety to the consumer as food, safety to the environment. In fact, those were the type of studies that were eventually part of the guidance document.

“Despite having done those studies in 1995, we had to wait until 2009 when there was a regulatory pathway available. Once that was in place, we completed the last few studies and submitted them.

“Then, in October of 2010, the Center for Veterinary Medicine held a public meeting where they announced the results of their review. In that meeting, they basically said the fish was an Atlantic salmon and was as safe to eat as any other Atlantic salmon. They felt the product was safe for the consumer and environment.

“Subsequent to that there was a lot of controversy from environmental groups and NGOs that opposed (the fish). The FDA, being very cautious, considered all the complaints and petitions they received and responded to them before moving on a final approval. That approval finally came Nov. 19, last Thursday.

“We’re very happy to have received approval. This is the first GM food animal approved anywhere in the world. We’re hoping this means there will be other approvals both in the United States and other countries.”

The last time we spoke the FDA was in a 60-day comment period after the 2013 environmental assessment. At the time your tone was one of great uncertainty. Between then and today, when did you start to feel optimistic?

“To be honest, when the approval came it was a surprise. We just decided we’d done the science, the studies were clearly acceptable and we wouldn’t give up. We hoped the FDA would make a science-based decision.

“There’s a long history of delays of environmental assessments. Those delays were likely based in policy and politics, not science. We’re pleased to have gotten through all of that. It was a tough battle, unfortunately.”

Did you have any prior warning that the ruling was coming down?

“No. The FDA doesn’t give you any heads up. There’s no schedule provided and whenever they’re ready to go, they go. In a way this was an early Christmas present.

“We think this is terrific, that’s it’s great for American science, for American food production, for the American consumer. There are a lot of reasons this pioneering application has been issued.”

The plan

The plan is to take salmon eggs from Canada to a Panamanian facility to be raised. Are you ramping that up immediately?

“We have a hatchery in Canada. The eggs – which was actually the product approved – will be shipped to Panama. Panama is sort of a pilot scale, a small farm we built to ensure we could grow the salmon to market size. We’ll be spawning fish in the next few weeks so we’ll have more eggs to ship.

“First, though, we’ll rebuild our business plan. We’ll also be thinking about how to move to grow the business. Now that we’ve gotten the approval, there are new issues to consider.

“Because of the way the application works, you have to have a place approved to produce eggs and a place approved to grow out the fish. If we want to seek additional approvals, we have to go back to the FDA. But there is a mechanism for that.”

Are you looking at genetically modifying Chinook or some other type of salmon?

“No. There’s a lot of noise about this so it’s something folks need to understand.

“Atlantic salmon can’t breed with the Pacific salmon – they’re of a different genus and species. A lot of the things you see in the newspapers and being said by Alaskans claiming this fish is a threat simply isn’t true. Again, it’s a scientific fact – and it’s been known for many years -- that Atlantic and Pacific salmon can’t breed. And we’re not interested in developing a Pacific salmon.

“Atlantic salmon is very popular in the United States. We import about 300,000 tons annually and it’s also one of the most extensively cultured animals. If can get even a small percentage of that, we’d be thrilled.

“If you’re eating an Atlantic salmon it was almost certainly raised off a coast – Chile, Norway or Canada. There are no wild-caught fisheries for Atlantic salmon because the habitats have been destroyed and they were overfished.

“There are other things we’re working on in our research pipeline. We’re interested in disease prevention, treatments – basically applying modern science and modern molecular genetics to aquaculture. Aquaculture is a great way to produce sustainable protein in a safe, healthy, sustainable way for the environment.”

Future, safeguards

Since the FDA decision, any inquiries from fish farmers wanting your fish?

“We get such requests almost every month and have for some time. There are a lot of U.S. people and those from other countries that are very interested in this. They see the benefits of superior growth, better efficiency, better feed conversion and environmental sustainability.”

Safeguards in place at the Panama facility?

“There is perimeter fencing. There are people there 24 hours a day to work and guard the facility. All the waterlines have barrier filters and the fish are completely contained.

“There are SOPs in place so every one of the barrier filters are checked daily to ensure integrity. The water systems are also checked daily along with required management oversight and reports.

“The facilities in both Panama and Canada have been inspected by the FDA. Canadian and Panamanian government agencies also do inspections. We’re intensely inspected and there are extraordinary containment devices in place.

“These are valuable fish and we want to keep them properly in our facilities. Also, even though they don’t present an environmental risk, the perception by some people that are concerned is something we understand. So, we have extensive containment at both locations.”

Anything else?

“I want to thank your readers for their support. Historically, we’ve received support from the agriculture community, the people who know where food comes from. We’re very grateful for that. It’s amazing how little the general public understands where food comes from.

“I hope this opens a new era where we can continue to produce high-quality protein and high-quality food for the American consumer. And hopefully that can be done with a lot less controversy.”

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