Gene editing in agricultural animals is an impressive technology, but growth has been hindered due to burdensome regulatory protocols. A task force report recently released by experts from the American Association of Veterinary Medical Colleges (AAVMC), as well as the Association of Public and Land-grant Universities (APLU), concluded the protocols must be remodeled in order for productive gains to be realized.
“For the U.S. to remain a global leader in shaping how livestock products are produced in sufficient quantity to be cost-effective sources of protein in the human diet and of high quality to provide essential nutrients, the federal regulatory landscape for approving and monitoring of genetic engineering applications must evolve,” the report read.
Federal regulatory approval and monitoring processes rooted in science and streamlined with the pace of development are essential, the experts said. This also includes public acceptance of food from gene-edited animals.
The impacts of selective breeding over the past 10,000 years are notable, but increasing production efficiency to provide animal protein for 9.8 million people is not achievable with this strategy alone, according to the report. Currently, the Food and Drug Administration (FDA) regulates genetic work on food animals as an “animal drug,” whereas the USDA regulates the technologies with crops.
The experts offered several recommendations on how gene editing could be regulated while addressing mutual interests for all stakeholders, and “what a modernized and progressive framework” should look like. Their recommendations include:
• Update the existing FDA regulatory framework — FDA regulatory framework is viewed by many genetic engineer developers as “ambiguous, glacial in pace, and cost prohibitive.” A coordinated assessment and approval process between FDA and USDA could establish a framework that is streamlined, cost effective and ensures safe food.
• Develop a protocol for gene editing that is separate from GMOs — Gene editing and GMOs have distinctive differences. The task force recommends making gene editing applications that could have arisen in nature and be propagated via selective breeding, such as insertions, deletions and rearrangements, be regulated separately from traditional GMOs.
• Develop streamlined assessment and approval processes — The report recommends “logic-based, streamlined assessment and approval processes” based on the type of genomic change being created; the method used; the animal’s welfare; and potential negative impacts on the environment.
• Develop a regulatory channel for approving edited animals that could have arisen in nature — The task force also recommends approving gene-edited animals possessing gene edits that could have arisen in nature as safe for human consumption. The process could be streamlined by focusing on the animal’s welfare rather than the process of creating a genetic alteration.
“Gene editing has the capacity to create transformational change in our food production systems,” said Dr. Noelle Cockett, president of Utah State University, a renowned geneticist, and chair of the task force. However, Cockett noted in order to realize the benefits in production and safety, we need a regulatory structure that has kept pace with technology.
The task force also recommended several other steps to pave the way to reap the benefits of gene editing:
• Establish a national coalition of scientific experts, bioethicists, and engagement specialists from APLU and AAVMC member institutions to serve as a board and think tank;
• Engage with federal legislators, staffers and the White House Office of Science and Technology Policy;
• Distribute the report to stakeholder organizations such as land-grant universities, FDA, USDA and others; and
• Establish a University Research Consortium that will facilitate collaborative research and educational initiatives.
The report concluded by saying the regulatory community across the globe looks towards the U.S. for stewardship and leadership.
“In this regard, the APLU and AAVMC task force recommends that the USDA and FDA come together and shape a harmonious, transparent, evidence based, and forward-looking regulatory process in step with the current scientific progress.” — Anna Miller, WLJ managing editor
