The Regulatory Status of Animal Biotechnology and Consumer Acceptability of Genome-Edited Animals (Part 2)

Biotechnology in the animal industry is a vast, promising frontier. Researchers have turned to animal biotechnology to address the increased demand for animal products that is faced by challenges such as climate change, pests and diseases, the growing global population, and conserving limited resources. Genome editors have been a point of interest by scientists around the world to achieve targeted DNA sequence alterations to affect traits of agricultural animals without the time-consuming processes of traditional animal breeding techniques. But as animal biotech R&D continues to progress rapidly, can the regulations of different countries keep up with it? And how acceptable will its products be to the public once commercialized?

From September to December 2020, ISAAA and its partners conducted a series of five webinars and two online workshops that focused on animal biotechnology. These were attended by an audience of hundreds from 51 countries. The webinars produced a peer-reviewed scientific article written by the organizers that summarized the topics presented as well as the key points of discussions with additional context. The publication aims to reach a wider network of individuals who are interested to know more about animal biotechnology to facilitate knowledge sharing beyond the webinars. This article provides some of the highlights of the paper.

Part 2 of 2. Read Part 1 to know more about Genome Editors, Genome-Edited Animals in the Pipeline, and Food Safety Evaluation of Genome-Edited Animals.

Regulations on Animal Biotechnology: Environmental Safety Assessment

Aside from food safety assessment, regulators also make sure that genome-edited animals do not pose risk to environmental health before it is deemed suitable for agricultural production. To do this, harm, hazard, and risk need to be determined clearly. Harm is defined as an ecological perturbation resulting in negative impacts to a receiving ecosystem. On the other hand, hazard is an agent, such as any genetically modified (GM) or genome-edited organism, that has the potential to do harm to the ecosystem. Risk is the likelihood of harm resulting from exposure to the hazard.

Risk assessment is science-based but at the same time considers the values of the stakeholders involved. This helps the process to be more transparent by including all existing knowledge and enhancing understanding and acceptance of the risk analysis for all involved. A formal risk assessment analysis uses the following steps:

1. Identify the protection objectives.
2. Identify hazards that can cause harm in the context of projection objectives.
3. Define exposure for a genome-edited animal, and assess the likelihood of exposure.
4. Quantify the likelihood of harm given that there is exposure.
5. Multiply the resulting probabilities to yield a quantitative risk estimate.

Risk is then classified into levels, ranging from high to low, with only negligible risks being considered acceptable. After estimating the risk posed, a decision is handed down by a regulating body. If risk is found to be acceptable, the product may move forward. But if the risk is unacceptably high, risk management measures need to be identified and the residual risk quantified to determine if the product may move forward or otherwise.

However, the obstacle posed for genome-edited animal research is that the current risk assessment processes were developed during the GM technology phase, hence their relevance to genome-edited animals is unclear. Discussions about the applicability of the risk assessment framework to different classes of modified organisms are currently on-going, specifically to clarify the scope of regulatory definitions and international harmonization of regulations. But while policy approaches of different regions differ due to institutional structures and regulatory histories, similar key technical approaches can still be identified to help foster harmonization of risk assessment frameworks.

Animal Biotechnology: Beyond Regulations

The success of any product of biotechnology does not rely on passing food and environmental evaluations alone. For its benefits to be fully optimized by beneficiaries, it needs market readiness and public acceptance. The latter is affected by consumer perception on animal biotech products. Some factors such as improved animal health, decrease in negative environmental impact, and benefits to human health were found to be highly valued by consumers and can help gain acceptance. But it was also noted that consumer perceptions of animal biotechnology leaned negatively because of the technology it represents and not due to the technology itself.

One of the important elements of public acceptance is trust, especially when information is contested. The public must be able to trust the regulatory system and the regulators for a biotech product to gain acceptance. To attain this, shared values among the public need to be identified because shared values are three to five times more important in building trust compared to sharing facts or demonstrating expertise. Also, science-based risk communication is important in addressing the public’s concerns and other technical risk estimates. Thus, key players like scientists, companies, and government officials must be able to express universal values in their developing messages for the public. Regulators have an important role too, as it was found that 50% of consumers trust what regulatory authorities say about genome editing, and 63% trust regulatory authorities to explain the science behind safe food production.

Helping the public understand the science behind the technology, the regulatory systems, and the roles of key players involved promotes transparency in regulatory the process, which in turn gains public trust and fosters innovation. This eases the adoption of animal biotechnology and encourages the market readiness of all participants in the value chain like producers, farmers, and distributors to help pave way of the products to consumers. When all the elements are achieved, genome-edited animals may prove to be successful in accomplishing their objectives of improving animal welfare while achieving food security and protecting the environment.

The open-access paper is published by Transgenic Research. Read the full article to find out more.