Feds Reconsider Pathway for Genetically Modified Foods

Dec 4, 2015  | 00:07:38  | Ep4115

The federal government’s recent approval of genetically modified salmon is raising questions among consumers and scientists about what other biological innovations might end up on American’s dinner tables.

The first genetically engineered produce – the Flavr-Svr tomato – was approved for human consumption 21 years ago by the Food and Drug Administration, less than three years after it was entered for consideration. The AquAdvantage salmon, which the FDA decided in mid-November was safe for the environment, became the first genetically engineered animal approved for human consumption.

Kevin Wells, University of Missouri, animal science: “Perhaps one day we will be eating genetically engineered animals. Therefore if this technology is useful to solve a problem, we can use this technology to solve a problem.”

Some have applauded the methodical process through which the FDA considered AquaBounty’s request to sell the salmon. However, University of Missouri professor and genetic engineering expert Kevin Wells believes the Massachusetts-based company’s two-decade wait for a decision frightened away many would-be biotech scientists.

Kevin Wells, University of Missouri, animal science: “It took so long that most of us began to have the opinion that nothing was ever going to get approved – that the United States wasn’t going to approve genetically engineered animals. And, as a result, no other country would either. So most of us began to find it irresponsible to encourage students in this area, and we are now missing a generation of scientists because of this delay.”

Wells, who was on the federal Veterinary Medicine Advisory Committee that examined AquaBounty's application, believes the government’s decision took so long that the company's original patents will have expired long before the fish reaches grocery store freezers.

The U.S. stamp of approval carries significant weight internationally and numerous companies are waiting for the federal nod to release genetically modified animals.

The FDA denied Market to Market's Freedom of Information Act request seeking an accounting of how many genetically engineered animal projects have been submitted for approval, and how long those projects have been waiting for a governmental yea or nay. Market to Market has appealed the FDA’s decision.

According to AquaBounty officials, their Atlantic salmon have been genetically modified with genes from Chinook salmon and from the eel-like Ocean Pout so they will reach market size twice as quickly as their conventional counterparts. One of the company’s goals with the new genetic line is to reduce fishing pressure on wild species. The fish, all sterile females, are slated to be raised at land-based facilities in Panama and Canada.

Leslie Kux, FDA, associate commissioner for policy: “For approval, the sponsor has to demonstrate three things if it’s a food-producing animal: that the GE change is safe to the animal, that the resulting food is safe for humans or animals – depending on where it is going to end up, mostly humans – and then is it effective. Does the GE material do what the sponsor claims it will?”

Many Americans remain leery of genetically modified foods and those on either side of the issue are voicing frustration with the government’s regulatory process. In response, the White House in July 2015 directed the various agencies dealing with biotechnology-related food products to improve the process in terms of clarity, transparency and efficiency.

John P. Holdren, Office of Science and Technology Policy, White House: “The current complexity of the array of regulations and guidance documents developed under the 1986/1992 framework ... make it unduly difficult for new firms with new products to navigate the process while also making it difficult for the public to understand how the process works and to have confidence in the results.”

Government leaders, scientists and consumer group representatives agreed during an FDA-sponsored “public engagement session” in October that officials must ensure a more efficient process without neglecting safety.

Richard Engler, senior chemist, Bergeson & Campbell, PC: “While too much regulatory oversight can stifle promising innovations just as they are gaining momentum and market competitiveness, too little will result in the public rejecting the technology due to a lack of understanding and trust.”

Doug Gurian-Sherman, senior scientist, Center for Food Safety: “Regulations must be developed that fully regulate engineered foods and organisms for all types of risks, including long-term food safety risks and indirect environmental harm, which are currently inadequately regulated.”

Several commented that dividing applications for new biotech products among the FDA, EPA and USDA is inefficient, and that a single agency should employ specialized scientists to more effectively scrutinize each project.

Megan Palmer, Center for International Security & Cooperation, Stanford University, biological engineer: “As the scale, complexity and importance of biological technology increases, it is essential that we build the infrastructure that helps everyone better understand biotechnology, its benefits, its risk, and its policy and practices. Over the last five years, I’ve experienced the frustration of practitioners and regulators alike who are trying to understand how they can better navigate and help evolve this system to assess its risks and benefits.”

Kelly Drinkwater, a representative of the non-profit agency iGem, which is dedicated to the advancement of synthetic biology, encouraged the government to continue its early consultations with those developing genetically engineered food products.

Kelly Drinkwater, iGEM Foundation: “The most effective safety interventions with teams are not through paperwork but through early email exchanges as they are brainstorming their ideas. Early and informal has been a key even when a project is entirely hypothetical.”

Tim Schwab, a research scientist from the environmental activist group Food and Water Watch, asked government officials to make plans for continued observation of new genetic lines after they are approved.

Tim Schwab, researcher, Food & Water Watch: “FDA should also do a comprehensive post-market surveillance – a process that should include labeling of foods containing GMOs.”

Dr. Nina Fedoroff, a molecular biologist and National Medal of Science recipient, said new tools have simplified genetic modification, creating opportunities to head off agricultural problems that may result from climate change.

Dr. Nina V. Fedoroff, National Medal of Science: “They provide unprecedented control over what genes are modified and how – something that has never been possible in the entire history of agriculture.”

And far from the halls of government, even those who work with animals that might someday be genetically modified to be healthier or faster growing, are cautious in their optimism.

Dr. Alden Frischmeyer, Grinnell Veterinary Clinic, Iowa: “The only reservation I have is we don’t know what effects we are having on evolution. In other words, there is no guarantee going forward what modifying animals and plants will do. The science says it’s safe. I believe it’s safe. But there isn’t a guarantee with the test of time like we’ve had with evolution. So I’m in favor but with some reservations.” 

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