Gene editing, under FDA regulation, faces an impractical, lengthy and expensive approval process, said National Pork Producers Council (NPPC) president, David Herring, in a statement on Tuesday. FDA’s misrepresentation of a gene-edited livestock research project is its latest stall tactic, NPPC said.
NPPC believes gene editing should be regulated by the USDA if the United States wants to maintain its global leadership position in agriculture.
"While countries like China, Canada, Brazil and Argentina are moving quickly on this advancement to gain competitive advantage, the United States is falling far behind because of the FDA's precautionary regulatory approach," said Herring, a hog farmer from Lillington, N.C.
Gene-editing technology promises significant animal health benefits, including immunity to disease and a reduction in the need for antibiotic use, Herring added.
In a recently published FDA analysis of a research project involving two gene-edited calves, NPPC said in its statement that FDA omitted important information, including:
• As noted in the analysis, unintended alterations materialized in the gene-edited calves. However, FDA failed to recognize the animals in question were never intended for the food supply or to be presented for regulatory approval. They were part of a controlled research program at a major university, and their genomes were made freely available to the scientific community in order to advance the study of gene editing in agricultural animals. The scientists will publish their own detailed analysis of their program in order to be transparent and to foster scientific dialogue about this promising new technology.
• The technique used to edit these animals continues to be refined and is not used for all applications of gene editing in animals. Edits that seek to "knock-out" a gene do not utilize foreign DNA as was the case in the research project analyzed. These are findings that would come to light under any reasonable regulatory review process and are in no way unique to the FDA's approach of regulating gene-edited animals.
“Their ‘gotcha’ approach inhibits much-needed investment and completely misrepresents the scientific community's intent to be transparent about the development of potential gene edits and how they may someday be deployed,” NPPC said in the statement.
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