Scientists who have been researching gene-editing may be disappointed in the eve of the new administration. A last-minute proposal will be addressing CRISPR and other cutting-edge technologies in the field of medicine.
New draft rules released by the US Food and Drug Administration (FDA) on Jan. 18 will be addressing transformed animals using genome-engineering tools. However, it is still unclear just how the new Trump administration will be carrying the proposals.
Of the three proposed regulations, perhaps the one with the most impact is that all animals whose genomes have been "intentionally altered" will be examined for safety and efficacy -- akin to new drugs.
According to Scientific American, a lot of researchers have hoped that the FDA will be less strict about "evaluating" organisms with edited genomes using methods such as CRISPR than it is for animals that have been given DNA from different species. Alison van Eenennaam, an animal geneticist at the University of California, Davis, called the proposals "Insane."
"The trigger for their regulation is whether the animal was intended to be made, and what does intention have to do with risk?" she says. "The risk has to do with the attributes of the product."
She added the proposals may opt businesses, non-profit organizations and universities to abandon the development of genetically-engineered animals. This is similar to a cautionary tale in the genetically-engineered salmon created by AquaBounty Technologies in the early 1990s.
According to Nature, the Maynard-based company has spent $60 million in developing the fish. It's an Atlantic salmon with genes from Chinook salmon that would allow it to grow rapidly.
However, they had to wait for 20 years for the FDA to review more than 50 studies that demonstrated that the salmon poses no unusual risks before the agency approved them in November 2015. By then, the salmon cannot be sold until the FDA has decided whether it must be genetically modified.
Scott Fahrenkrug, the chief scientific officer at gene-editing company Recombinetics in Minnesota, has produced hornless dairy cattle by inserting a gene from naturally hornless beef cattle into a breed of the same species used in milk production. This could help reduce the controversial practice of dehorning.
Recombinetics told the FDA last December that it intends to market food from its cows without FDA approval, but with a label that read "generally recognised as safe." This is bolstered by the US Department of Agriculture's announcement last April that it would forego the regulation of a mushroom that has been genetically modified to resist browning.
Nature says the agency said the fungus, created using the CRISPR-Cas9 method, did not require approval because it did not contain genes from other species, same with Recombinetics' cattle.
Recombinetics plans to protest against the agency's plan to the incoming Trump administration which will oversee finalization of any new regulations.
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