Developments in genetic modification of cattle and implications for regulation, safety and traceability

Abstract

Genetic modification techniques, in particular novel gene editing technologies, hold the yet unfulfilled promise of altering genetic traits in farm animals more efficiently than by crossbreeding, allowing for a more rapid development of new cattle breeds with distinct traits. Gene editing technologies allow for the directed alteration of specific traits and thereby have the potential to enhance, for instance, disease resilience, production yield and the production of desired substances in milk. The potential implications of these technological advancements, which are often combined with animal cloning methods, are discussed both for animal health and for consumer safety, also with consideration of available methods for the detection and identification of the related products in the food supply chain. Finally, an overview is provided of current regulatory approaches in the European Union (EU) and major countries exporting beef to the EU, for products from animals bred through established practices as well as modern biotechnologies.

Comparison of Gene Editing Versus Conventional Breeding to Introgress the POLLED Allele Into the Tropically Adapted Australian Beef Cattle Population

“…However, when using this approach, a cloning step is required to produce an animal from the edited cell line. SCNT cloning is prohibited in several European countries ( van der Berg et al, 2020 ). Additionally, cloning itself is also inefficient with only 6–15% of transferred embryos resulting in a viable calf ( Chavatte-Palmer et al, 2012 ).…”

“…Currently, the global regulatory status of gene edited animals is uncertain, and is the primary concern for further investment and development of gene edited animals ( Zhao et al, 2019 ; van der Berg et al, 2020 ). Editing that does not introduce novel recombinant DNA sequences would not be treated differently to conventional breeding in some countries, e.g., Argentina ( Whelan and Lema, 2015 ) and Brazil ( United States Department of Agriculture [USDA], 2019 ), whereas in the United States intentional genomic alteration in animals are subject to mandatory premarket regulation as a new veterinary drug ( Solomon, 2020 ).…”

“…Editing that does not introduce novel recombinant DNA sequences would not be treated differently to conventional breeding in some countries, e.g., Argentina ( Whelan and Lema, 2015 ) and Brazil ( United States Department of Agriculture [USDA], 2019 ), whereas in the United States intentional genomic alteration in animals are subject to mandatory premarket regulation as a new veterinary drug ( Solomon, 2020 ). In the European Union, animal cloning is currently prohibited which would preclude SCNT-enabled editing approaches as modeled in this paper, and in 2018 the European Court of Justice ruled that organisms obtained by directed mutagenesis, including gene editing, will be regulated as GMOs ( van der Berg et al, 2020 ). Conversely, in Canada traditional mutagenesis is not regulated unless it produces a novel trait.…”