Based on sound science and a comprehensive review, the U.S. Food and Drug Administration Nov. 19 took several steps regarding food from genetically engineered plants and animals, including the first approval for a genetically engineered animal intended for food, AquAdvantage Salmon.
The agency also issued two guidances for manufacturers who wish to voluntarily label their products as containing ingredients from GE or non-GE sources: a draft guidance on labeling foods derived from Atlantic salmon and a final guidance on foods derived from GE plants.
The FDA has approved AquaBounty Technologies’ application for AquAdvantage Salmon, an Atlantic salmon that reaches market size more quickly than non-GE farm-raised Atlantic salmon. The FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act, because the recombinant DNA construct introduced into the animal meets the definition of a drug. In this case, the rDNA construct introduces a trait that makes the AquAdvantage Salmon grow faster.
“The FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty Technologies regarding AquAdvantage Salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine.
The AquAdvantage Salmon may be raised only in land-based, contained hatchery tanks in two specific facilities in Canada and Panama. The approval does not allow AquAdvantage Salmon to be bred or raised in the U.S. In fact, under this approval, no other facilities or locations, in the U.S. or elsewhere, are authorized for breeding or raising AquAdvantage Salmon that are intended for marketing as food to U.S. consumers.
As required by the National Environmental Policy Act, the FDA completed an environmental assessment to determine whether approval of the application would result in significant effects on the quality of the human environment in the United States. The FDA has determined that the approval of the AquAdvantage Salmon application would not have a significant environmental impact because of the multiple and redundant measures being taken to contain the fish and prevent their escape and establishment in the environment.
These measures include a series of multiple and redundant levels of physical barriers placed in the tanks and in the plumbing that carries water out of the facilities to prevent the escape of eggs and fish. Finally, the AquAdvantage Salmon are reproductively sterile so that even in the highly unlikely event of an escape, they would be unable to interbreed or establish populations in the wild.
The FDA will maintain regulatory oversight over the production and facilities, and will conduct inspections to confirm that adequate physical containment measures remain in place. In addition, the Canadian and Panamanian governments will also be conducting inspections of the facilities.
Meanwhile, the FDA also has published guidances on voluntary labeling of food from genetically engineered sources.
Under the Federal Food, Drug, and Cosmetic Act, the FDA can only require additional labeling of foods derived from GE sources if there is a material difference—such as a different nutritional profile—between the GE product and its non-GE counterpart. In the case of the AquAdvantage Salmon, the FDA did not find any such differences.
“We recognize that some consumers are interested in knowing whether food ingredients are derived from GE sources,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “The FDA is issuing two guidance documents that explain how food companies that want to voluntarily label their products can provide this information to consumers.”
These two guidance documents include a draft guidance on voluntary labeling indicating whether food has or has not been derived from GE Atlantic salmon and a final guidance on voluntary labeling indicating whether food has or has not been derived from GE plants.
Although companies can always voluntarily add labeling to their products as long as it’s truthful and not misleading, these guidances provide recommended actions for manufacturers who may wish to voluntarily label their products with information about whether the foods contain ingredients from GE sources.
The agency is accepting public comment for 60 days starting on Nov. 23 via instructions in the Federal Register on “Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived from Genetically Engineered Atlantic Salmon.”
Among groups supporting the guidances were the American Farm Bureau Federation, the American Soybean Association, the American Seed Trade Association and the Biotechnology Industry Organization.
“The FDA rejected petitions to the White House for mandatory labeling of GMOs,” AFBF President Bob Stallman said. “This is a victory for consumers and farmers alike. This administration has long been a champion for nutrition, and today’s action recognizes how biotechnology is changing the way we grow food—for the better.
“Farmers and ranchers are producing more with fewer resources, without sacrificing nutrition or compromising food quality and safety. The administration sees this, and so does the nation’s leading authority on food safety. We also learned that the FDA has placed its stamp of approval on a genetically engineered animal product, AquAdvantage Salmon. This week’s announcement is a milestone for expanding farmers’ and ranchers’ ability to produce nutritious food critical to a healthy diet.
“Thanks to these decisions announced today, consumers will continue to benefit from access to a variety of nutritious foods in the marketplace. Consumers have a right to know what’s in their food, but they should be given the facts—facts grounded in science. New voluntary guidance on labeling from the FDA will help companies provide more helpful information for those consumers looking to make the best choices for their families.”
ASA president and Brownfield, Texas, farmer Wade Cowan said in a statement, “We have consistently said that explicit labeling should be reserved for health or safety concerns, and science has time and time again proven that these concerns don’t apply to GMOs.
“Slapping a warning label on the front of a food product when no such warning is warranted will only serve to steer people away from the safe and affordable food they need to feed their families. The White House has chosen science over rhetoric today, and we applaud them for it.”
American Seed Trade Association President and CEO Andrew LaVigne said he applauded “the FDA’s decision to stand up for science and reject calls for mandatory labeling of GE foods.
“The FDA has made it clear—as it did in its 1992 policy—that there is insufficient evidence to suggest that foods derived from GE organisms differ from foods derived from non-GE organisms in any meaningful way, or that they present any greater safety concerns. ASTA continues to support voluntary labeling and the U.S. government’s use of sound science in agriculture policies.”
BIO Executive Vice President of food and agriculture Brian Baenig said in a statement that “BIO appreciates the several actions taken by the FDA this week which highlight the administration’s support for commonsense, science-based food policy.
“Notably the FDA reaffirmed its longstanding policy that foods containing biotech ingredients are compositionally the same and as safe and nutritious as conventionally produced foods; thus distinguishing them with a mandatory label would mislead consumers by falsely implying they are different.”
Not everyone was thrilled with the FDA announcements.
“Foods with genetically modified ingredients line the shelves of our supermarket aisles, and today the federal government gave the green light to the first GMO salmon,” said Colin O’Neil, the Environmental Working Group’s director of agriculture policy. “Yet we will still have no way of knowing whether what we’re eating has been genetically modified.
“With this latest decision to approve GMO salmon as food, our leaders in government and the food industry need to finally give Americans the right to know.”
EWG claims that more than 90 percent of Americans support GMO labeling.
Larry Dreiling can be reached at 785-628-1117 or email@example.com.