Towards progressive regulatory approaches for agricultural applications of animal biotechnology

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.

First person – Ajay Singh

ABSTRACT First Person is a series of interviews with the first authors of a selection of papers published in Journal of Cell Science, helping early-career researchers promote themselves alongside their papers. Ajay Singh is first author on ‘ Local DNA synthesis is critical for DNA repair during oocyte maturation’, published in JCS. Ajay is a postdoc in the lab of Dr H. B. D. Prasada Rao at the National Institute of Animal Biotechnology, Hyderabad, India, investigating the quality of and lifespan-determining factors of mature oocytes in mammals.

CRISPR, animals, and FDA oversight: Building a path to success

Technological advances, such as genome editing and specifically CRISPR, offer exciting promise for the creation of products that address public health concerns, such as disease transmission and a sustainable food supply and enable production of human therapeutics, such as organs and tissues for xenotransplantation or recombinant human proteins to treat disease. The Food and Drug Administration recognizes the need for such innovative solutions and plays a key role in bringing safe and effective animal biotechnology products to the marketplace. In this article, we (the Food and Drug Administration/Center for Veterinary Medicine) describe the current state of the science, including advances in technology as well as scientific limitations and considerations for how researchers and commercial developers working to create intentional genomic alterations in animals can work within these limitations. We also describe our risk-based approach and how it strikes a balance between our regulatory responsibilities and the need to get innovative products to market efficiently. We continue to seek input from our stakeholders and hope to use this feedback to improve the transparency, predictability, and efficiency of our process. We think that working together, using appropriate science- and risk-based oversight, is the foundation to a successful path forward.

The Ethics of Farm Animal Biotechnology from an Anthropological Perspective

Over the past 11,000 years, humans have domesticated a wide range of animals for different purposes designed to serve the human economy, society, and religious activities. The resulting mutual dependence between humans and their domestic partners created anthropogenic landscapes designed to sustain and protect their members. In this paper, we review the literature on the latest insights in interdisciplinary anthropological research on the evolution of animal domestication and breeding and put them in the context of the contemporary ethical debate on animal welfare and the application of modern biotechnology to animal breeding. Opponents of the use of animal biotechnology tend to see breeders often as enablers of industrial farming that would seek selective business advantage at the expense of the environment and animal welfare. Many applications of animal biotechnology may, however, also help to address environmental and animal welfare concerns in an effective way. Moreover, recent archeological and genetic research findings on the history of animal domestication reveal a distinctive kind of mutualism in the human–animal relationship based on a gradual co-evolutionary process with clear benefits for both parties in the relationship. These insights challenge the popular Neo-Darwinian account of unilateral adaptation only benefiting the more powerful party. Instead, they support the hypothesis that humans do not just adapt, but actively shape the environment through cultural niche construction (CNC) that also involves care and protection for domesticated animals. These empirical findings should also be taken into account in the contemporary ethical debate on animal welfare, which has become increasingly detached from the real-world efforts to improve animal welfare through best practices.

Manipulating the Epigenome in Nuclear Transfer Cloning: Where, When and How

The nucleus of a differentiated cell can be reprogrammed to a totipotent state by exposure to the cytoplasm of an enucleated oocyte, and the reconstructed nuclear transfer embryo can give rise to an entire organism. Somatic cell nuclear transfer (SCNT) has important implications in animal biotechnology and provides a unique model for studying epigenetic barriers to successful nuclear reprogramming and for testing novel concepts to overcome them. While initial strategies aimed at modulating the global DNA methylation level and states of various histone protein modifications, recent studies use evidence-based approaches to influence specific epigenetic mechanisms in a targeted manner. In this review, we describe—based on the growing number of reports published during recent decades—in detail where, when, and how manipulations of the epigenome of donor cells and reconstructed SCNT embryos can be performed to optimize the process of molecular reprogramming and the outcome of nuclear transfer cloning.

Prospects and Validity of Laboratory Cage Tests Conducted in Honeybee Research Part Two: New Possibilities for Use of Laboratory Cage Tests in Response to Challenges Revealed at the Turn of the 20th and 21st Centuries

Nowadays, cell cultures are a standard tool in animal biotechnology, but the problem with honeybees is the constant lack of appropriate cell lines to be used in in vitro research. Until the imperfections of bee tissue cultures are resolved, researchers have to conduct experiments on bees in laboratory cage tests (LCTs).At the turn of the 21st century many new hazards for beekeeping appeared. An early recognized problem was the Colony Collapse Disorder and Honey Bee Depopulation Syndrome, which were associated with the harmfulness of pesticides and strictly linked with a decline in bee immunity. Such problems in LCTs were attempted to be resolved through research on the interactions between biostimulators and antiparasitic drugs. LCTs allow the relationship between the dose of a specific factor and its impact to be determined, which can be used in the establishment of reference values. Furthermore, LCTs may be a useful tool in understanding the function and role of bee gut flora.Using the honeybee as an animal model is possible thanks to knowledge of the honeybee genome and bee biology and the similarity between some physiological and biochemical processes and those occurring in humans. So far, LCTs have been used to understand better human aging, learning and gene expression regulating. This is facilitated by the advanced development of medicine and molecular genetics, and in the future the use of honeybees may become a standard in biochemical or gerontological research.