Trout and salmon have been genetically combined with other fish species so they grow twice as fast. The fish have been raised as food and would be marketed as food, but the Food and Drug Administration has classified them as drugs.
A/F Protein, which developed the fish, has been told to test the fish as if it were a chemical. "We effectively have to prove that our product is going to be as safe as if it were a drug," says Elliot Entis of A/F Protein.
These fish are seen as drugs, in part, because there's no law that regulates transgenic animals. The technology is ahead of Congress. So when mixed species fish became a reality, the FDA gave the job to its animal drug division, the Center for Veterinary Medicine.
"They are not treating them as a food. They are treating them as a drug, and that's a big mistake," says Andrew Kimbrell of the Center for Food Safety, a public interest group. Under drug regulation there won't be any long-term human safety study, he says. The fish won't even be tested on lab rats, he adds.
"The drug process is a closed process; it's not open to the public. It takes a much shorter time to go through because they are not doing the kind of tests they should be doing," he adds.
The FDA disputes that. An official told CBS News under drug testing, A/F Protein must prove gene-altered fish are biochemically the same as normal fish and are chemically safe to eat.
Entis disputes the notion that he's being let off easy.
"We have to know exactly what the gene produces on a molecular basis," says Entis. "We have to know where in the fish that gene is located. We to prove that the animal itself remains healthy throughout its life cycle. This is a costly, time-consuming procedure."
The company understands, though, this is not all about science.
There's consumer backlash against gene-altered crops, partly because the government never required long-term human studies. And those were plants. To sell the first gene-altered animal, the company's biggest fight may be for the public trust.
Review Andrews' prior report on how and why A/F Protein is developing genetically altered fish.