February 10, 2012
Genetically Engineered Salmon: Veterinary Drug or Food Additive?
There is a battle over the possible introduction of genetically engineered salmon into the American food supply. Aqua Bounty Technologies (ABT) seeks approval of its genetically engineered (GE) salmon (AquaAdvantage), in which the Chinook growth hormone gene is introduced into Atlantic salmon and engineered so that the gene is expressed year-round (rather than seasonally), greatly speeding up the maturation process; the company forecasts that the salmon has the “potential to grow to market size in half the time of conventional salmon.” In Alaska, significant opposition exists to the introduction of the product into the seafood market. The company has applied for FDA approval of the salmon; now comes a legal challenge to the FDA’s classification of the product in a manner that could alter the stringency of review. The current paradigm for the review of the ABT salmon is that the added gene is reviewed as if treated with a veterinary drug: "the rDNA construct in the resulting GE animal is thus a regulated article that meets the drug definition" - and is thus overseen by the FDA's Center for Veterinary Medicine (CVM) in the FDA. In 2010, a CVM report stated that there were no significant safety or environmental issues raised by the ABT salmon. Now, Consumers Union, Center for Food Safety and Food and Water Watch filed a petition which asks the FDA to classify the added gene as a food additive, rather than as a veterinary drug. If the growth hormone gene is a food additive, the FDA would be required to conduct an inquiry into whether the added component is GRAS (generally regarded as safe); this would trigger a broader food safety review. Note the temporal distinction when the gene is treated as a drug administered to fish during maturation or as a food additive (administered) eaten by people. Clearly, the food additive classification is one that could be applied to the product as it is meant to be consumed. There are parallels with many of the genetically engineered crops, which contain genes that have agronomic benefit in the field (withstanding herbicide or conferring pest resistance) and then remain in the crop as it becomes a food substance. Here is the same shift: a fish engineered to grow faster (for economic gain) becomes the food product with a novel gene. Does that trigger the food additive review process? Can a veterinary-based review supply adequate oversight for the introduction of a genetically engineered food product? To date, the GE crops do not undergo a rigorous food safety review because the FDA regards the introduced DNA as GRAS. Will the ABT salmon (as potentially the first GE animal food product to enter the food supply) encounter the paradigm shift sought by the petition?