Genome Editing and US laws

Maxim Rousseau, Polit.roo

The US Federal Agency for Food and Drug Administration (FDA) has published draft rules governing the use of animals whose genome has been edited using CRISPR and other advanced technologies (“Regulation of Intentionally Altered Genomic DNA in Animals” – VM). The reaction of scientists to this project is described by the website of the journal Nature (Amy Maxmen, Gene-edited animals face US regulatory crackdown).

The document appeared on January 18, two days before the end of the powers of President Obama and his administration, and it is still unclear whether it will be considered under the new President Trump. However, a number of scientists have already expressed serious concern. The proposed rules provide for the same testing of animals for safety and efficacy that medicines undergo before issuing a permit for their use in the United States. Scientists hoped that the norms would be softer in relation to animals whose genome was edited with precise tools (CRISPR, TALENs and the like). Animal geneticist Alison van Eenennaam from the University of California at Davis has already called the proposed document insane.

Many fear that the proposed rules will force businesses, universities and non-profit organizations to abandon the development of animal genetic engineering. They recall the story of genetically modified salmon created by AquaBounty Technologies in the early 1990s. Then this company spent $ 60 million on introducing some genes of chinook salmon (Oncorhynchus tshawytscha) into the genome of Atlantic salmon (Salmo salar) so that the fish would grow faster. But the firm had to wait 20 years while the FDA reviewed more than 50 studies demonstrating that such salmon does not pose any threats. In November 2015, the agency finally approved the fish, but it is still impossible to sell it, since the FDA has not yet determined how such a product should be marked.

The FDA also has a complicated relationship with Recombinetics, which has created a method for obtaining hornless cows by inserting the gene of those hornless breeds into the genome of those breeds that have horns. If the method is applied, it will greatly reduce the cost of the procedure for removing horns from live cows, which is carried out by farms to reduce injuries. In December 2016, Recombinetics informed the FDA that it intended to market dairy products from such cows without agency approval, labeling them "generally recognized as safe." The company refers to the decision of the US Department of Agriculture, which in April 2016 allowed the sale of genetically modified mushrooms, in the genome of which a gene that prevents the darkening of the cut was inserted using the CRISPR method. The permission was obtained on the basis that there were no genes belonging to other species in the genome of these fungi. Recombinetics cows also meet this condition.

Scott Fahrenkrug, who heads the genetic engineering department at Recombinetics, says he is stunned by the new FDA requirements. "They suggest that an already existing allele that we have been eating for thousands of years should be tested for safety, because now we have inserted it into the genome of another cow," he wonders. The company plans to appeal against the new FDA plans to the incoming President Trump. The public discussion of the draft new rules will last until April 19, 2017, so the FDA may still change its approach in accordance with the feedback received.

Scientists whose work is not related to biology are satisfied with unexpected news. Sociologist Jennifer Kuzma from the University of North Carolina says: "The public is suspicious of animal genetic engineering. When editing the genome, we observe unplanned effects, so it was wise for the FDA to check all these genetically modified organisms until sufficient data is collected."

Alison van Enennam looks at another aspect of the problem. Taking such measures, she said, will lead to the fact that almost all work in the field of genetic engineering will be carried out by huge multinational corporations that have sufficient resources to conduct large-scale tests. "If the scientific community doesn't stand up and say this is crazy, we will be doing a disservice to innovation," van Enennam concludes.

Portal "Eternal youth" http://vechnayamolodost.ru  20.01.2017