Towards progressive regulatory approaches for agricultural applications of animal biotechnology

Abstract

Traditional breeding techniques, applied incrementally over thousands of years, have yielded huge benefits in the characteristics of agricultural animals. This is a result of significant, measurable changes to the genomes of those animal species and breeds. Genome editing techniques may now be applied to achieve targeted DNA sequence alterations, with the potential to affect traits of interest to production of agricultural animals in just one generation. New opportunities arise to improve characteristics difficult to achieve or not amenable to traditional breeding, including disease resistance, and traits that can improve animal welfare, reduce environmental impact, or mitigate impacts of climate change. Countries and supranational institutions are in the process of defining regulatory approaches for genome edited animals and can benefit from sharing approaches and experiences to institute progressive policies in which regulatory oversight is scaled to the particular level of risk involved. To facilitate information sharing and discussion on animal biotechnology, an international community of researchers, developers, breeders, regulators, and communicators recently held a series of seven virtual workshop sessions on applications of biotechnology for animal agriculture, food and environmental safety assessment, regulatory approaches, and market and consumer acceptance. In this report, we summarize the topics presented in the workshop sessions, as well as discussions coming out of the breakout sessions. This is framed within the context of past and recent scientific and regulatory developments. This is a pivotal moment for determination of regulatory approaches and establishment of trust across the innovation through-chain, from researchers, developers, regulators, breeders, farmers through to consumers.

Progress and opportunities through use of genomics in animal production

“…The tools available at that time were limited in their specificity and, consequently, the transgenes were integrated randomly into the genome, resulting in unpredictable transgene expression [134,135]. The use of transgenic approaches is still actively researched in some areas (e.g., biopharmaceutical production and biomedical research) and potential benefits for agricultural production continue to be investigated [135][136][137]. However, their use in food production has generally been limited due to consumer scepticism over safety, welfare, and ethics, with high regulatory barriers or outright bans having been subsequently introduced in many countries [135].…”

“…However, their use in food production has generally been limited due to consumer scepticism over safety, welfare, and ethics, with high regulatory barriers or outright bans having been subsequently introduced in many countries [135]. To date, only one transgenic food product has been marketed to the public (The Aqua Bounty AquAdvantage salmon in the USA, with regulatory approval now also gained in Brazil), but only >25 years after its initial production [137,138]. Similar early excitement surrounded the potential value of using cloning in livestock production, fuelled by the development of Dolly the sheep using somatic cell nuclear transfer (SCNT).…”

“…Although success rates of over 90% have been reported, the efficiency of the editing process in animals generally remains relatively low (typically <25% [137,145]). This affects the ease with which GnEd can be used in existing breeding programs, particularly for species that produce only a relatively small number of embryos.…”

“…In those circumstances, it would likely require public or other sources of funding to support relevant research. It is interesting to note that the Gates Foundation is already supporting several research projects in this area, with one jointly funded with UKAid [137].…”

“…In Japan, animals and plants developed using site-directed nucleases are not considered GMO, provided there are no insertions of extracellular processed nucleotides in the host genome (effectively limiting the use of HDR to the insertion of small number of nucleotides [183]. Companies are also encouraged to voluntarily notify regulatory bodies when any GnEd product is in development or being considered for marketing [137].…”