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American regulators release path for genetically modified salmon



NEW YORK (AP) – US regulators Friday gave the green light to salmon genetically modified to grow about twice as fast as normal, but the company behind it can face legal challenges before the fish can be sold domestically.

The Food and Drug Administration said it raised a warning that had prevented AquaBounty from importing its salmon eggs to its Indiana plant, where they would be grown before being sold as food. The agency noted that the salmon has already undergone safety assessments and that it raised its warning because the fish would be subject to a new regulation that would require companies to disclose when a food is bioengineered.

The move comes despite an ongoing case of a coalition of consumer, environmental and fishing groups that challenged the FDA's approval of the fish.

"We believe that a remedy in our case will stop the sale of the fish before being allowed to be sold," said George Kimbrell, legal director of the Food Safety Center, one of the groups suing the FDA.

Founded in 1

991, AquaBounty has worked for many years with safety assessments and regulatory barriers to selling its fish in the United States. In 2015, the salmon became the first genetically modified animal approved by the FDA for human consumption. But the agency then issued a notice that stopped Maynard, Massachusetts-based company from importing its fish eggs, until guidelines for publishing genetically modified foods were resolved.

Called AquAdvantage, the fish is Atlantic salmon changed with DNA from other fish species to grow faster, as the company says will help increase the demand for animal protein, while reducing costs.

Sylvia Wulf, CEO of AquaBounty, says the company expects to get a final certification for its growing facility Albany, Indiana in the coming weeks. Salmon eggs can then be sent from the company's research and development facility in Canada, and will be harvested after about 18 months when they reach £ 10, she said.

Wulf said it has been difficult to engage companies in sales discussions because AquaBounty didn't do I don't know when it can start growing the fish in the US. She said that the salmon has already been sold in limited quantities in Canada, where it must not be labeled as genetically modified. Wulf said she did not expect the ongoing lawsuit to affect the company's US plans.

The genetically modified salmon is raised in tanks and bred to be female and sterile, measures to deal with fear that they may enter the environment and breed with wild fish.

But Kimbrell, from the Center for Food Safety, said that the company's own tests have shown that it is not 100% that the fish will be sterile, and what worries about it coming into the environment will grow if the company's operations are to be expanded.

He also noted that the publication regulations use the term "bioengineered", although most are more familiar with the term genetically modified. And he pointed out that companies can provide information through codes that must be scanned.

Implementation of the Regulations begins in 2020, although people may begin to see packet information earlier. Compliance becomes mandatory in 2022.

The genetic modification of AquaBounty's fish differs from gene-editing technology, allowing scientists to release specific genes to create properties without introducing foreign DNA. Companies also work to develop a number of re-edited crops and animals.

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Follow Candice Choi at www.twitter.com/candicechoi

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. AP is solely responsible for all content.


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