Genetic modification and engineering involve making changes to the genetic material of organisms, such as plants or animals, to introduce new traits or improve existing ones . The legalities surrounding genetic modification and engineering vary across different countries and regions.
United States:
In the United States, the term “genetic modification” is often used interchangeably with “genetic engineering” . However, there is no legal definition of “genetically modified organism” (GMO) in the U.S. Code of Federal Regulations . The U.S. Department of Agriculture (USDA) defines genetic modification as the production of heritable improvements in plants or animals for specific uses, either through genetic engineering or other traditional methods . The regulatory oversight of GMOs in the United States is primarily divided among three federal agencies: the USDA, the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). Each agency has specific responsibilities related to the regulation of GMOs, including their environmental impact, food safety, and labeling requirements.
European Union:
The European Union (EU) has established a legal framework to regulate the development and use of genetically modified organisms (GMOs) . The EU has a comprehensive approval process for GMOs, which includes a scientific risk assessment conducted by the European Food Safety Authority (EFSA) The EU’s regulatory framework for GMOs is based on the principle of precaution, and it requires the labeling of GMOs and their derived products. Member states have the option to restrict or prohibit the cultivation of GMOs on their territory .
Ethical Considerations:
The legalities of genetic modification and engineering are often intertwined with ethical considerations. Opinions on the limits and ethical implications of genetic engineering can vary depending on individuals’ worldviews and beliefs . Some argue that genetic engineering is a logical continuation of selective breeding and can be used to improve human medicine or reduce the use of experimental animals . Others raise concerns about the potential risks and unintended consequences of genetic modification, as well as the ethical implications of altering the genetic makeup of organisms.