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Regulatory changes needed for gene-edited animals

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COORDINATED FRAMEWORK NEEDED: New report from American Association of Veterinary Medical Colleges and the Association of Public and Land-grant Universities calls for cooperation between USDA and FDA on regulating gene edited animals.
Panel of university experts call for coordinated, streamlined approach between FDA and USDA on biotech animal approvals.

For the past several years, the Food and Drug Administration and USDA have battled in a turf war over which agency should be in charge of regulating gene-edited animals. New recommendations now call on updating the existing FDA regulatory framework and developing a coordinated and streamlined assessment and approval process between USDA and FDA.

For the past 18 months a panel of experts convened by the American Association of Veterinary Medical Colleges and the Association of Public and Land-grant Universities studied the issue found that in order for gene editing in agricultural animals to unleash enormous gains in productivity, “a remodeling of the federal regulatory landscape is needed” for potential productivity gains to be realized.

The “AAVMC/APLU Gene Editing in Agriculture Task Force Report” suggests current regulatory protocols have not kept up with technological change and must be modernized for society to realize the many benefits of new scientific capabilities.

Related: Animal gene editing turf war battle continues

“For the promises of applying gene editing in livestock to be realized, federal regulatory approval and monitoring processes that are rooted in science and streamlined with the pace of development, as well as public acceptance of food derived from gene-edited animals, are essential,” authors say in the report. “Thus, a remodeling of the federal regulatory landscape is needed for the U.S. to sustain its place as a global leader and innovator in the animal agriculture sector and keep pace with the exponentially expanding global human population.”

Public attitudes toward GMOs have tended to be negative. At present, the leading edge of biotechnology application for genetic engineering of livestock has moved from using transgenesis to gene editing.

“Both the technical science and intended outcomes of gene editing are substantially different compared to transgenesis. As such, regulatory statutes should not be applied as a ‘one size fits all’ model; rather, contextual categorizing of the genetically altered animals that allows for fluidity and applying logic-based decision making, while still ensuring safety, is needed,” the report notes.

Suggested changes

Currently the FDA regulates genetic work on food animals as an “animal drug” under protocols developed during the early phases of the Biotechnology Revolution. The USDA regulates these technologies with crops. However, the regulatory hoops required under FDA’s animal drug status has created timely delays for those on the animal side.

Related: FDA, USDA still at odds regarding livestock gene editing

The report contains several specific recommendations for regulatory officials and lawmakers to consider as they envision “what a modernized and progressive framework for the regulation of gene-edited livestock in the U.S.” should be.

The report notes that assigning federal regulatory jurisdiction to a single agency is challenging and has potential to elicit conflict that thwarts innovation. A remodeling of the federal regulatory landscape is needed for the U.S. to sustain its place as a global leader and innovator in the animal agriculture sector and keep pace with the exponentially expanding global human population.

“A coordinated assessment and approval process between the USDA and FDA is essential to establish a framework that is streamlined, cost-effective and ensures safe food, with the decision-making process anchored on logic and fact,” the report says.

The academics also suggest the regulatory framework should develop an evidence and logic-based decision-making protocol for gene editing applications that is regulated separately from transgenic-based GMOs which result from the integration of recombinant DNA.

They also suggest to develop streamlined assessment and approval processes that categorize gene-editing applications based on: a) the type of genomic change being created, b) the method used for creating the genomic change, c) the impact on the welfare of the animal and d) the potential for negative impact on the environment.

And finally, they call for the development of a regulatory channel for approval of gene-edited agricultural animals with genomic structures that could have arisen in nature as safe for human consumption.

“Gene editing has the capacity to create transformational change in our food production systems,” says Dr. Noelle Cockett, president of Utah State University, a renowned geneticist and chair of the task force. “But in order to realize those benefits in production and safety, we need a regulatory structure that has kept pace with technology. Our task force has thoughtfully and carefully considered many different aspects of this issue, including perspectives from the scientific and agricultural communities, and we have made our recommendations. We hope this work will meaningfully inform the work of government officials as they develop the best public policy in this area.”

For more than 10,000 years, humans have been using selective breeding in domesticated animals to achieve desired characteristics like improved growth and resiliency, according to the report. While it has been useful over the centuries, selective breeding is time consuming and requires multiple generations before results can be achieved.

The advent of biotechnology substantially advanced those capabilities. Following the invention of recombinant DNA technology, scientists were able to quickly produce generations of animals with desired characteristics by fusing strands of DNA that coded for those changes through a process known as transgenesis.

Additional insight needed

“Gene editing is a key tool in our effort to foster greater food security across the world and produce healthier, more sustainable food,” APLU President Peter McPherson says. “Having a regulatory framework to ensure the safety and integrity of such food is important, but the current system is outdated and not constructed to deal with the modern state of gene-editing technology and processes. In partnering together, our nation’s public and land-grant universities and veterinary colleges have charted a path forward that will allow this field to advance while maintaining appropriate and effective oversight.”The expert panel outlined a series of steps that could pave the way for fully reaping the potential benefits of gene editing technology:

  • Establish a national coalition of scientific experts, bioethicists and engagement specialists from APLU and AAVMC member institutions to serve as a sounding board and think-tank related to the modernization of the existing federal regulatory framework.
  • Engage with federal legislators, staffers and the White House Office of Science and Technology Policy (OSTP) and inform them on key issues related to regulatory approval and monitoring processes for gene-editing applications in livestock.
  • Distribute the task force report to stakeholder organizations and agencies like U.S. land-grant universities, the FDA, the USDA, the Food and Agricultural Organization of the United Nations, the Gates Foundation and others.
  • Establish a University Research Consortium of scientific experts developing gene-editing applications in livestock that will facilitate collaborative research and educational initiatives.

The APLU and the AAVMC decided to take action in this area following inquiries from members of Congress to then Food and Drug Administration Acting Commissioner Norman E. Sharpless concerning current regulatory processes. That provided the impetus for the AAVMC and the APLU to organize a fall 2019 symposium for leading scientists and other scholars called “Gene Editing in Livestock: Looking to the Future.” During that event, 23 of the nation’s leading experts from academia, government, industry and professional groups gathered to examine a series of questions ranging from the nature and safety of this promising technology to its ethical implications.

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