FDA and USDA are working toward the modernization of GMO regulation, with three notices published in the Federal Register January 19 to this effect. The agencies’ strategies pay particular attention to the differentiation between older genetic engineering techniques and newer gene editing technology.
The goal, according to FDA’s website, is to “protect health and the environment while preventing unnecessary barriers to future innovation and competitiveness.”
FDA’s two notices explore gene editing in animals and in plants for food. In the former, FDA expands the scope of existing guidance on the regulations concerning these animals, differentiating between the two major GMO techniques.
“Genome editing is a much more precise method of making changes to the genome of a plant, animal, or other living organism than methods used previously to make such changes,” FDA explains.
In its notice and request for comments regarding genome editing in plants, FDA asks specifically if there are categories of genome-edited plants similar enough to plants developed conventionally, via such techniques as hybridization, that voluntary premarket consultations could be skipped.
FDA also asks in this notice if there are categories that would pose greater risks than conventionally bred plants.
The USDA notice explores “importation, interstate movement, and the environmental release of GE organisms,” reports Food Navigator. The USDA seeks to reduce the burden on producers of genetically modified organisms that do not pose plant, pest, or noxious weed risks, which, according to USDA, includes most organisms produced with gene editing techniques.
These notices have been posted in order to further the strategy for modernizing biotechnology products, in accordance with the GMO labeling law signed by President Obama last July and demands by Congress that USDA create federal GMO regulations by 2018.
It remains unclear how the advent of the Trump administration will change the strategies and support of these regulation procedures on a federal level, particularly given the President's January 31 executive order calling for the elimination of two federal rules for every new regulation.
“I think the executive order at least in the near term is likely to have its intended effect of slowing down, if not stopping, the adoption of new regulations,” Stuart Pape, an attorney at Polsinelli and former lawyer at the FDA, told Politico.
Specifically, the order could delay the completion of a study on whether electronic labels such as QR codes are an effective way of labeling products containing GMOs. This study was expected to be completed by the middle of this year.
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