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Browsing by Author "Karembu, Margaret"

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    Enabling regulatory policy globally will promote realization of the potential of animal biotechnology
    Hallerman, Eric M.; Bredlau, Justin; Camargo, Luiz S. A.; Dagli, Maria L. Z.; Karembu, Margaret; Kovich, Daniel; Muia, Anne N.; Murrone, Mariana L.; Rocha-Salavarrieta, Pedro J.; Romero-Aldemita, Rhodora; Tizard, Mark; Walton, Mark; Wray-Cahen, Diane (2024-03-06)
    Animal biotechnologies have the potential to improve the sustainability and security of our global food systems. Government regulatory authorities are responsible for ensuring the safety of food their citizens consume, whether it is produced via conventional breeding methods or biotechnologies. While some countries have implemented animal biotechnology oversight policies, many countries have yet to develop theirs. Historically, regulatory approvals were required before products of biotechnology could enter the marketplace, and the high cost of the approval process limited the number and types of animal and plant products that sought approval. Only one biotech animal in the world that was developed for food production has reached the market under a GMO or rDNA approval process. The advent of genome editing techniques has revolutionized the scientific approach to introducing changes into DNA sequences and how biotechnology can be used to enhance agricultural breeding. Regulatory dialogs about biotechnology also have changed as a result of these new technologies. Regulatory agencies have begun to respond to these scientific advances, and a growing number of countries are looking to modernize regulatory approaches for these products, based on risk (or lack thereof) and similarity to organisms that could be produced via conventional breeding methods. Advances in animal biotechnology, especially genome editing, can accelerate the incorporation of valued phenotypes in animals, including enhanced yield, disease resistance, resilience to changing climate, and improved animal welfare, as well as food qualities valued by consumers. For animals with these biotechnology-introduced traits to enter agricultural production and reach consumers, clear risk-proportionate regulatory approaches must be in place, and to facilitate international trade of animal products, regulatory processes need to be aligned and compatible. Effective scientific public communication is crucial to build public trust in precision animal biotechnology and risk-proportionate regulatory approaches. An international workshop on regulatory approaches for animal biotechnology was convened in 2022 with 27 countries represented. We synthesize here technical progress, development of regulatory policy, and strategies for engagement with diverse publics on animal biotechnology reported in the workshop. Our goal is to encourage development and implementation of risk-proportionate regulatory approaches and policies in a global context.
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    Towards progressive regulatory approaches for agricultural applications of animal biotechnology
    Hallerman, Eric M.; Bredlau, Justin P.; Camargo, Luiz Sergio A.; Dagli, Maria Lucia Zaidan; Karembu, Margaret; Ngure, Godfrey; Romero-Aldemita, Rhodora; Rocha-Salavarrieta, Pedro Jesus; Tizard, Mark; Walton, Mark; Wray-Cahen, Diane (Springer, 2022-01-09)
    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.