U.S. Approved Transgenic Animals as a Food for Sale Reflection

Recently, a fast-growing Atlantic salmon became famous overnight after becoming the first transgenic animal approved for human consumption in the United States.

This landmark decision by the U.S. Food and Drug Administration (FDA) liberated the "premium" salmon from its 20-year regulatory dilemma. At the same time, it also allows the industry to begin its revival after waiting for any signs that the product may enter the market.

“It opens up the possibility of using this technology,” said Alison Van Eenennaam, an animal geneticist at the University of California, Davis. “The regulatory hurdles really inhibit the world from using it.”

The FDA's decision came at a time when the U.S. government is reassessing how to regulate genetically modified crops and animals. On July 2, the White House Science and Technology Policy Office stated that these regulations will be updated in the coming year, and this is the first time since 1992. At a meeting on November 18, the United States Department of Agriculture (USDA) discussed preliminary plans for a guide to modifying GM crops.

A key driver of these discussions was the recognition that existing regulations may not cover crops and animals that have been transformed using cutting-edge technologies such as the CRISPR-Cas9 system. These cutting-edge technologies allow researchers to make targeted changes to the genome. The USDA has already made a decision that its regulations cannot be applied to crops whose genomes have been edited. Van Eenennaam said that it is not yet clear how the FDA will regulate the use of this technologically modified animal.

"A lot of things happened these days," said Greg Jaffe, head of biotechnology at the Public Interests Science Center in Washington. "But it's clear that until the salmon decision was made, the main concern was the crop."

In 1995, AquaBounty Technology, headquartered in Maynard, Mass., filed for FDA approval of the listing of genetically modified salmon for the first time. The FDA completed the food safety assessment in 2010 and issued an environmental impact statement at the end of 2012. The long delay between the completion of these steps and the taking of a final decision has led to rumors of political interference.

However, Laura Epstein, senior policy analyst at the FDA's Veterinary Drugs Center, said that the approval lasted long because it was the first of its kind. "For most of the products of the same kind, we will be very cautious." Epstein said that before issuing a decision, the agency had to collect a lot of public opinion.

It is not yet clear what kind of performance this salmon will have in the market. "Excellent" fish can produce additional growth hormone, allowing it to grow to market size in 18 months instead of the usual 3 years. However, Scott Fahrenkrug, CEO of Recombinetics, an animal biotechnology company based in St. Paul, Minnesota, said that since the AquaBounty company first filed its application, the aquaculture industry has also cultivated traditional salmon, which has also grown rapidly.

This is followed by consumer acceptance. Some supermarket chains have stated that they will not sell such salmon because even if they are fully productive, they will only occupy a very small portion of the total salmon imports in the United States. "This is just a drop in the ocean." Jaffe said, "Consumers will have to look around for genetically modified salmon, which is totally different from avoiding them."

Of course, the FDA's approval was immediately opposed by some environmental and food safety groups. Although AquaBounty uses physical and biological safeguards to reduce the chances of Salmon fleeing into the wild, opponents fear that accidental releases will alter the natural ecosystem. At the same time, they are extremely dissatisfied that the FDA will allow the fish to be sold without the need to affix any labels that show it as a transgenic animal.

"A lot of people said, 'Yes, we want to label it'," said Jaydee Hanson, senior policy analyst at the Washington Center for Environmental Protection, a food safety center. "If it is really such a good product, the company itself should Indicated that it will be labeled."

The FDA declined to comment on whether other GM animal applications are being reviewed by regulators. However, Fahrenkrug said that his company is developing such animals, including cattle that do not need to inhibit horn growth and pigs that do not need to be castrated.

Recombinetics uses Fahrenkrug's genomic editing technology that does not require FDA approval to transform animals. The FDA regulates the use of "DNA recombinant construction" modified animals, but Recombinetics' animals are improved by injection of proteins and RNA into the embryo. "It's a cure, not a transgene," Fahrenkrug said.

The FDA has not yet shown how this type of animal will be considered, but Fahrenkrug has approved the approval of the genetically modified salmon as a sign that the agency is willing to allow them to enter the market. "I'm very optimistic now," he said. (Zonghua)

"China Science Journal" (2015-12-03 3rd Edition International)


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