Leading Scientists Assert GRAS Status for Gene-Edited Livestock Gene-edited livestock is safe for human consumption; Pre-market approval by the FDA should not be required

ST. PAUL, MN – In a communication published in this month’s prestigious Nature Biotechnology journal, Recombinetics, a St. Paul-based gene-editing company founded by Chief Executive Officer and Chairman of the Board Scott Fahrenkrug, Ph.D., 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.

The Food and Agricultural Organization of the United Nations expects global demand for meat and milk to double by 2050. To meet this demand, livestock producers must increase productivity without significantly increasing the amount of land, water and other agricultural inputs used for livestock production.

Recombinetics’ Dr. Fahrenkrug was optimistic, commenting that, “Genetic improvements of livestock using gene editing establishes a non-GMO-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 published commentary from 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 FDA 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.”

Instead, the authors suggest that such products definitively qualify for GRAS status, “Generally Recognized As Safe,” under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA), and designates that a chemical or substance added to food is considered safe by experts, and is exempt from the usual FFDCA food additive tolerance requirements.

Among the points made by these authors, “Genome editing can be used to make genetic alterations identical to naturally occurring variants,” arguing that, “such alterations logically fall outside the current federal regulatory purview.” They concluded that “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 an invited presentation by Dr. Fahrenkrug to the National Academy of Science at their 153rd annual meeting.