Leading scientists assert GRAS status for gene-edited livestock

Scientists argue that gene-edited livestock safe for human consumption and should not require pre-market approval by FDA.

In a communication published in this month's Nature Biotechnology journal, Recombinetics, a St. Paul, Minn.-based gene-editing company founded by chief executive officer and chairman of the board Scott Fahrenkrug, reported the precise genetic dehorning of dairy cattle using TALENs, without any off-target effects.

Physical dehorning of cattle, which is done to protect animals and producers from accidental injury, is not only costly but painful for the animals and has come under scrutiny owing to public concerns about farm animal welfare, according to the announcement.

Fahrenkrug noted, "Genetic improvements of livestock using gene editing establishes a non-(genetically modified organism)-based method for crossbreeding to more rapidly harness nature's bounty nature's way, and with outcomes identical, albeit much faster, than classical breeding."

The strong, scientific consensus emerging about the safety of gene-edited food suggests that numerous livestock traits developed by Recombinetics to enhance productivity and improve animal health and welfare could be rapidly commercialized.

An accompanying commentary published in the journal written by leading scientists from several major research universities asserted that livestock products containing native and heirloom versions of genes should not require pre-market approval by the Food & Drug Administration prior to commercialization, even when introduced by gene editing.

"Given that DNA is generally regarded as safe to consume and that genome editing can be used to produce precise analogs of the naturally occurring mutations we routinely consume in conventionally bred plants and animals, there would appear to be no scientific or other logical reason to single out the 'process' of genome editing for onerous regulation," the scientists said.

Instead, the authors suggested that such products definitively qualify for "generally recognized as safe" (GRAS) status under sections 201(s) and 409 of the Federal Food, Drug & Cosmetic Act designating that a chemical or substance added to food is considered safe by experts and is exempt from the usual food additive tolerance requirements of that law.

"Genome editing can be used to make genetic alterations identical to naturally occurring variants," the authors pointed out, arguing also that "such alterations logically fall outside the current federal regulatory purview."

They concluded, "Given that the United States has no specific legislation regulating animal breeding, there would appear to be no authority for the FDA to regulate varieties that carry naturally occurring alleles produced using genome editing."

This position was widely echoed during Fahrenkrug's invited presentation  to the National Academy of Science at its 153rd annual meeting.

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