The two draft guidance were originally released in January, which discuss the steps that the federal agency takes to clarify how it regulates specific biotechnology products. The recent announcements were in line with the federal agency’s commitments highlighted in the “National Strategy for Modernizing the Regulatory System for Biotechnology Products” issued in September last year. The document aims to ensure that the FDA is efficiently equipped to evaluate any risks associated with future biotechnology products.

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FDA outlines pros, cons of genome-editing technology

In its blog the FDA Voice, the federal agency outlined that recent scientific innovations have led to the development of more efficient and precise methods in modifying plant, animal, and microorganism genomes to produce ideal traits. According to the FDA, these genome editing technologies were relatively easy to use, and may have extensive applications to a wide range of sectors including the medical, food and environmental industries. The federal agency also noted that genome-editing technologies may have potential use in the introduction, removal, or replacement of one or more specific nucleotides at a specific region in the organism’s genome. According to the agency, a number of research are currently at work to determine how genome-editing technologies can be applied to the following:

• Treatment of  HIV, cancer, or rare medical conditions
• Control or modify organisms that carry infectious diseases such as Zika-bearing mosquitoes and lyme disease-causing mice
• Enhance the health and welfare of animals that produce food
• Modify specific characteristics of food plants or fungi

However, the federal agency also stressed on the potential risks associated with genome editing technologies. According to the FDA, the risks include the technology's effects on individual genomes, and its potential impact on the environment and ecosystem.