(CN) - The Food and Drug Administration has the authority to regulate drugs used in genetically modified organisms after a federal court ruling on a new type of salmon that reaches maturity faster.
The ruling that allows FDA oversight of GMOs comes after the regulatory agency placed restrictions on how and where the genetically modified salmon is allowed to grow. The FDA’s reasoning for the regulation is meant to reduce the potential for the new breed of salmon from mixing with normal salmon, according to the ruling.
The FDA was slapped with a lawsuit by a number of environmental and industry groups that take issue with the process the FDA used to approve what many have dubbed “Frankenfish.”
“The lawsuit is both a broadside attack on the FDA’s authority to regulate the genetic engineering of animals and a targeted attack on the particular process by which the agency approved the salmon,” U.S. District Judge Vince Chhabria of the Northern District of California stated in the 23-page ruling.
The opinion criticized the lawsuit brought by environmental agencies by noting that if their argument succeeded, it would have left the genetic engineering of animals without any regulation.
“The plaintiffs’ broadside attack has a head-scratching element to it,” Judge Chhabria wrote. “Although they insist the FDA lacks the authority to regulate the genetic engineering of animals, the plaintiffs have not explained how this conduct can otherwise be regulated under current law.”
Chhabria said that a lack of FDA regulations would create a “regulatory void,” and leave companies completely free to engineer animals without oversight.
Judge Chhabria pointed to the differences and classifications of modified animals for determining the regulatory authority of the FDA.
According to the ruling, modified goats have been used to produce anticoagulant milk, which was then used to produce medicines to fight blood clots. That difference constituted a distinction between animal byproducts and “genetically engineered animals destined for the kitchen table.”
Despite those distinctions, the judge said the FDA’s authority was still valid.
“Under the plain language of the Food, Drug, and Cosmetic Act, the FDA has the authority to require companies to seek its approval before creating and breeding genetically engineered animals,” Judge Chhabria wrote. “Perhaps the genetic material used to modify an animal does not seem like a ‘drug’ in the colloquial sense, but it is the statutory definition that matters.”
The suit challenging the FDA’s authority on genetically modified animals was filed by the Institute for Fisheries Resources.
“There is a huge risk that these GMO fish could, if they escape into the wild, either compete with wild salmon for food, or what is far worse to hybridize with wild salmon stocks, causing "genetic pollution" of an entire gene pool, spreading genes that are maladaptive and could collapse a whole population of wild salmon in catastrophic -- and probably permanent -- ways,” said Glen Spain, Northwest regional director for the institute in a statement.
The genetically modified salmon in question isn’t the first of its kind, nor is it the first to receive FDA approval, according to the ruling.
Previously, AquaBounty Technologies used a similar technique to create high growth rate salmon in which they used genetic material from the Pacific Chinook salmon and the ocean pout.
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