FDA plan to regulate a gene-edited animal as a ‘drug’ will ‘choke’ research, experts say


Despite the Trump administration’s calls to increase innovation in biotechnology in a new draft proposal, experts say the classification of genetic editing and engineering as a drug continues to choke the industry.

[T]he federal agency that oversees genetic modification of animals announced plans to “advance an efficient, science-based pathway to market for safe animal biotechnology-derived products.” The United States Food and Drug Administration bills this “Action Plan” as a way to help scientists and start-ups bring plants and animals with edited genomes to the public, but retains some key limitations ….

The FDA has long regulated food-producing animals that have been modified with genetic material added from unrelated organisms, known [as] “transgenic” animals. The first of these—the “AquaAdvantage” salmon—took more than 20 years to be cleared for consumption in the U.S., but, so far, it’s only been sold in Canada ….

Related article:  Buy organic, local and non-GMO? 9 popular practices that aren't so eco-friendly after all

Eric Hallerman, professor of fish conservation at Virginia Tech, advised the FDA to approve the fish in 2015. Currently, genetically engineered animals must go through a rigorous regulatory approval, showing that the alteration does not harm the animal or the environment.


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