By Dr. Margaret Karembu

The ISAAA family was privileged to co-host the 4th International Animal Biotechnology Regulatory Perspectives conference, which has been running as virtual series from September 2020.  This was a slight shift from our usual focus on Crop Biotechnology over the last two decades. Hosting the conference gave us an opportunity to address one of the most frequently asked questions while disseminating our signature knowledge product, the Annual Global Status of Commercialized Biotech Crops  – how about progress in animal biotechnology? The conference brought together regulators, researchers, technology developers and communicators from around the world to share experiences of their respective countries and regions on animal biotechnology, with a special focus of regulatory approaches. Key thematic areas discussed so far include; Food Safety regulations for genetically engineered animals, Genome Editing regulatory approaches for animals and status of environmental and contained use regulations of genetically engineered animals.

At ISAAA, we believe starting these conversations with the global community is important to encourage constructive dialogue in the sector at this early stage than the endless debates witnessed over last two decades with biotech crops. Prior to the conference series, we hosted a global webinar to explore how molecular biology tools are being employed in improving animals’ suitability for agricultural, industrial and pharmaceutical applications.

On the face value, agricultural and food applications of animal biotechnology lag behind compared to the progress witnessed in plant biotechnology. To our surprise, deliberations so far indicate a highly vibrant sector. A number of countries – Argentina, Australia and New Zealand, Brazil, Canada, Kenya, the United Kingdom and the USA reported advanced animal biotech research on a number of applications in genetic modification and genome editing. A partnership with the International Livestock Research Institute (ILRI) for example, reported applying biotechnology to improve performance as in the case of resistance to trypanosomiasis in cattle, using surrogate sires to enable genetic improvement in small holder settings as well as applying biotech tools to conserve unique diversity in poultry. In the UK, the Roslin Institute at the University of Edinburgh’s collaborative team with Center for Tropical Livestock Genetics Health are applying genome editing to tackle the Porcine Reproductive Syndrome Virus in pigs, where vaccines in the market have proved non-cross protective. In North and South Americas, animal biotech is being applied for a number of traits for improving animal welfare, increased heat tolerance, sportive performance as well as productivity. Examples include genome editing aimed at delivering hornless dairy cattle, an important animal welfare benefit, considering the painful dehorning procedure. By far, the most advanced animal biotech food product is AquAdvantage salmon developed by AquaBounty in USA. The salmon has been engineered for faster growth to harvest weight, resulting in a 1.7 times increase in harvest with 25% less feed input compared to conventionally grown salmon. This is an important development considering the rise in protein demand globally, and seafood being a more efficient source than other animal proteins.

With all the impressive progress in products’ development and research, dialogue on regulatory approaches for GM and genome-edited animals is timely and presentations on this topic have been invaluable. A common observation indicates many countries had an original framework devoted to GM plants and had/have to develop a whole new set of legal texts. Participants felt this approach oftentimes lead to revision of whole existing texts, an onerous task for regulators. Some countries like Brazil, India and New Zealand just added some new rules for specific cases to existing legal framework. For the conduct of food safety assessments of foods derived from rDNA animals, the majority of countries have domesticated the international food code – Codex Alimentarius into national guidelines. Codex guidelines address safety and nutritional aspects of food consisting of, or derived from, animals that have a history of safe use as sources of food, and that have been modified by modern biotechnology to exhibit new or altered expression of traits.

In the African continent, only Kenya has drafted guidelines on regulation of contained use of GM animals. At the regional level, the Africa Union Inter-African Bureau for Animal Resources (AU-IBAR) clarified that AU does not set standards and regulations on biosafety for animal biotechnology. It however supports member states to develop policies and promotes harmonization on safety assessment approaches.

From the virtual series, it has emerged that animal biotechnology can contribute significantly towards addressing the challenge of food security and animal welfare among other attributes. As well, most regulatory frameworks have the capacity of handling products from genome editing adequately, with minor adjustments. A harmonized approach among countries would lead to a global template for use in regulating genome-edited products. The main asset for this is a substantial will and shared base of scientific knowledge and regulatory expertise. Conversely, the main obstacle is the divergence of national regulatory definitions of GMO and Genome editing.

A message of optimism came from a special breakout session with a highly motivated Early Career and Young Professionals both in research and regulatory fields. The group expressed high interest in biosafety and eager to face the intellectual challenge of helping solve real and perceived regulatory challenges through improved science communication and participation in international biosafety negotiations. They view themselves as drivers towards acceptance of new technologies and are ready to connect with each other. Initiating a database of Animal Biotech researchers and regulators through an inventory of techniques, traits and best practices in regulating animal biotechnology would be a good starting point to harness this potential.

The 4th International conference on regulatory approaches to animal biotechnology is collaboratively conducted by ISAAA, Inter-American Institute for Cooperation on Agriculture IICA), United States Department of Agriculture, and Virginia Tech. University, USA. The organizers are planning to conduct more sessions so be on the lookout for the next session! You can follow previous virtual deliberations at: 

Dr Karembu is Director of International Service for the Acquisition of Agri-biotech Applications (ISAAA) AfriCenter