# Construction of Sui Generis Supervision System for Gene-Edited Animals in China

## TL;DR

The paper proposes a unique regulatory system for gene-edited animals in China, distinct from regulations for genetically modified organisms and gene-edited plants.

## Contribution

It introduces a sui generis legal framework tailored to gene-edited animals, emphasizing animal welfare and traceability.

## Key findings

- Gene-edited animals require a distinct regulatory system due to their unique risks and ethical concerns.
- China should adopt a categorized supervision model that balances innovation with biosafety and animal welfare.
- International models suggest the need for flexible yet strict regulatory approaches based on public acceptance and technological maturity.

## Abstract

Gene-edited animals are obtained by modifying their own genes through gene-editing technology to acquire improved traits, and they have broad application prospects in both agricultural production and the biomedical field. Unlike genetically modified (GM) technology, gene editing carries lower technical risks and higher public acceptance, making the direct application of the GM supervision system inappropriate. Gene-edited animals are also distinct from gene-edited plants. Animals pose a risk of “escape” into natural ecosystems, and there are stricter ethical and social requirements such as laboratory animal welfare. Therefore, the supervision systems for gene-edited animals and plants should be differentiated. Grounded in the rapid development of emerging biological breeding technologies, this paper compares the supervision models for gene-edited animals in typical countries or regions. It proposes that China should gradually shift from a strict supervision model to an eclectic one and establish a sui generis supervision legal system for gene-edited animals under perspective from categorization, that is unique and independent of supervision systems for both GM animals and gene-edited plants. Meanwhile, it suggests strengthening the supervision of animal welfare and traceability labeling, so as to provide a critical path for balancing technological innovation, animal welfare and biosafety.

As an important achievement in agricultural sci-tech innovation, gene-edited animals are not only a basic element for rural revitalization but also the core of promoting the biological breeding industry. Exploring their supervision models and institutional construction is practically significant and supports new productive forces in agriculture. Currently, various research and development achievements have emerged, but China lacks clear legal norms for their transformation and food industry supervision, failing to meet modern breeding needs. Internationally, three main supervision models (strict, open, eclectic) are determined by each country’s technological level, legal soundness and public acceptance. To build China’s sui generis supervision system for gene-edited animals that is independent of both GM animals and gene-edited plants, top-level design should issue categorized supervision policies to clarify research and development and industrialization norms, including relevant principles and procedures; establish a pre-positive ethical review mechanism with strict animal welfare checks; set animal welfare damage as a certification revocation condition; build a traceability platform for gene-edited animals and their products; implement positive food labeling; strengthen public participation to balance technological innovation and risk prevention; safeguard biosafety and public interests; and provide legal support for industrialization of gene-edited animals.