But wait, there’s more GMO…. salmon!

Here we go again.. this time with salmon. Yes, I think many of us remember several years ago hearing or reading about some genetically altered salmon that would grow super fast and be ready to eat super quick, thereby increasing the supply of fish at your local supermarket at a theoretically lower price point for you the end consumer. Well, it seems that the FDA is near to a ruling on this particular one. They might indeed approve these Frankenfish for sale. Well, not to you and me directly, but to fish farms. Hey, they get to grow these little guppies on some manufactured fish pellets so that they get nice and fat, then ship them off to your local supermarket. But wait, why would you buy that medium fish when you could get that big fat one?!? Well, odds are that you won’t even know it is a GMO fish. The lobby to LABEL produce as GMO failed. Have fun eating your GM corn products. The same is likely to happen here. You might get to start eating GM salmon without even having the choice to OPT OUT of it, because you won’t know how the hell the fish was raised.

The Food and Drug Administration is seriously considering whether to approve the first genetically engineered animal that people would eat — salmon that can grow at twice the normal rate.

The developer of the salmon has been trying to get approval for a decade. But the company now seems to have submitted most or all of the data the F.D.A. needs to analyze whether the salmon are safe to eat, nutritionally equivalent to other salmon and safe for the environment, according to government and biotechnology industry officials. A public meeting to discuss the salmon may be held as early as this fall.

Some consumer and environmental groups are likely to raise objections to approval. Even within the F.D.A., there has been a debate about whether the salmon should be labeled as genetically engineered (genetically engineered crops are not labeled).

The salmon’s approval would help open a path for companies and academic scientists developing other genetically engineered animals, like cattle resistant to mad cow disease or pigs that could supply healthier bacon. Next in line behind the salmon for possible approval would probably be the “enviropig,” developed at a Canadian university, which has less phosphorus pollution in its manure.

The salmon was developed by a company called AquaBounty Technologies and would be raised in fish farms. It is an Atlantic salmon that contains a growth hormone gene from a Chinook salmon as well as a genetic on-switch from the ocean pout, a distant relative of the salmon.

Normally, salmon do not make growth hormone in cold weather. But the pout’s on-switch keeps production of the hormone going year round. The result is salmon that can grow to market size in 16 to 18 months instead of three years, though the company says the modified salmon will not end up any bigger than a conventional fish.

“You don’t get salmon the size of the Hindenburg,” said Ronald L. Stotish, the chief executive of AquaBounty. “You can get to those target weights in a shorter time.”

AquaBounty, which is based in Waltham, Mass., and publicly traded in London, said last week that the F.D.A. had signed off on five of the seven sets of data required to demonstrate that the fish was safe for consumption and for the environment. It said it demonstrated, for instance, that the inserted gene did not change through multiple generations and that the genetic engineering did not harm the animals.

“Perhaps in the next few months, we expect to see a final approval,” Mr. Stotish said.

But the company has been overly optimistic before.

He said it would take two or three years after approval for the salmon to reach supermarkets.

The F.D.A. confirmed it was reviewing the salmon but, because of confidentiality rules, would not comment further.

Under a policy announced in 2008, the F.D.A. is regulating genetically engineered animals as if they were veterinary drugs and using the rules for those drugs. And applications for approval of new drugs must be kept confidential by the agency.

Critics say the drug evaluation process does not allow full assessment of the possible environmental impacts of genetically altered animals and also blocks public input.

“There is no opportunity for anyone from the outside to see the data or criticize it,” said Margaret Mellon, director of the food and environment program at the Union of Concerned Scientists. When consumer groups were invited to discuss biotechnology policy with top F.D.A. officials last month, Ms. Mellon said she warned the officials that approval of the salmon would generate “a firestorm of negative response.”

How consumers will react is not entirely clear. Some public opinion surveys have shown that Americans are more wary about genetically engineered animals than about the genetically engineered crops now used in a huge number of foods. But other polls suggest that many Americans would accept the animals if they offered environmental or nutritional benefits.

Mr. Stotish said the benefit of the fast-growing salmon would be to help supply the world’s food needs using fewer resources.

Government officials and industry executives say the F.D.A. is moving cautiously on the salmon. “It’s going to be a P. R. issue,” said one government official, who spoke on the condition of anonymity because he was not authorized to speak about the issue.

Some of these government officials and executives said that F.D.A. officials had discussed internally whether the salmon could be labeled to give consumers the choice of avoiding them.

The government has in the past opposed mandatory labeling of foods from genetically engineered crops and animals merely because genetic engineering was used. Foods must be labeled, it says, only if they are different in their nutritional properties or other characteristics.

It would seem difficult for the government to change that policy. And experts say the administration may not have the legal authority to do so.

One possibility could be voluntary labeling by those who sell the fish.

Dr. Joshua M. Sharfstein, the principal deputy commissioner of the F.D.A., said in a statement: “Labeling is one of many issues involved with the review of genetically engineered animals for use in food. As has been publicly reported, the AquAdvantage Salmon is under review by the agency, and as we move forward, we will share information with the public.”

Mr. Stotish of AquaBounty said his company was not against voluntary labeling, but the matter was not in its hands because it would only be selling fish eggs to fish farms, not grown salmon to the supermarket.

He said the company had submitted data to the F.D.A. showing that its salmon was indistinguishable from nonengineered Atlantic salmon in terms of taste, color, vitamins, minerals, fatty acids, proteins and other nutrients.

“Our fish is identical in every measurable way to the traditional food Atlantic salmon,” Mr. Stotish said. “If there’s no material difference, then it would be misleading to require labeling.”

Virtually all Atlantic salmon now comes from fish farms, not the wild.

The F.D.A. must also decide on the environmental risks from the salmon. Some experts have speculated that fast-growing fish could out-compete wild fish for food or mates.

Mr. Stotish said the salmon would be grown only in inland tanks or other contained facilities, not in ocean pens where they might escape into the wild. And the fish would all be female and sterile, making it impossible for them to mate.

The F.D.A. is expected to hold a public meeting of an advisory committee before deciding whether to approve the salmon. Typically at such advisory committee meetings, much of the data in support of the drug application is made public and there is some time allotted for public comment.

But Gregory Jaffe, biotechnology project director of the Center for Science in the Public Interest, said such meetings often do not give the public enough time to analyze the data.

Justices Back Monsanto on Biotech Seed Planting

When the Supreme Court backs the conglomerates responsible for taking choice away from the consumer without their knowledge, there is something massively wrong. But then, this isn’t a particularly new situation is it? We seem to have a long history of those in Power making decisions against the betterment of the population. Why do that when the various special interest groups with fat stacks of cash that can afford to take people out to dinner and golf outings and fly around on private jets get to keep schmoozing them and lobbying for their vote?

The New York Times reports:

In its first-ever ruling on genetically modified crops, the Supreme Court on Monday overturned a lower court’s ban on the planting of alfalfa seeds engineered to resist Monsanto’s Roundup herbicide.

The decision was a victory for Monsanto and others in the agricultural biotechnology industry, with potential implications for other cases, like one involving genetically engineered sugar beets.

But in practice the decision is not likely to measurably speed up the resumption of planting of the genetically engineered alfalfa.

A federal district judge in San Francisco had ruled in 2007 that the Agriculture Department had approved the genetically engineered alfalfa for commercial planting without adequately considering the possible environment impact, as required by federal law. The judge vacated approval, known as deregulation of the crop, and also imposed a nationwide ban on planting those seeds. The ban was later upheld on appeal.

But the Supreme Court, in a 7-to-1 decision, said the lower court judge had gone too far, ruling that the national ban prevented the Agriculture Department from considering a partial approval. That avenue, the court said, would have allowed some of the alfalfa to be grown under certain conditions; for example, isolating it from conventional alfalfa.

“The district court barred the agency from pursuing any deregulation — no matter how limited the geographic area in which planting of RRA would be allowed,” Justice Samuel A. Alito Jr. wrote in the opinion, referring to Roundup Ready alfalfa.

Justice John Paul Stevens was the lone dissenter. Justice Stephen G. Breyer did not take part because his brother, District Judge Charles Breyer, had issued the original decision.

Because the Supreme Court left in place the lower court’s rejection of approving the crop, the Agriculture Department must either fully or partly approve it before growing can resume.

“I think the practical impact is nil,” said George A. Kimbrell of the Center for Food Safety, a Washington advocacy group that was part of a coalition of environmental groups and organic and conventional alfalfa farmers who had challenged the crop’s approval.

The Agriculture Department said Monday that it was on track to complete its environmental impact statement and approve the crop in time for next spring’s planting.

Speeding up planting beyond that could only occur if the agency pursues a partial approval while finishing its environmental assessment. But getting partial approval in time for this fall’s planting season — beginning in two months — might be difficult.

Still, David F. Snively, Monsanto’s general counsel, called the decision a significant victory. “Monsanto and farmers in the United States are thrilled with this decision, which is far-reaching in its look at the regulatory framework that should govern biotech crops,” Mr. Snively told reporters in a conference call.

The Supreme Court’s ruling could affect a similar case, also brought by the Center for Food Safety, involving Roundup Ready sugar beets.

In that case, a different federal judge in San Francisco ruled last September that the Agriculture Department had failed to adequately assess the environmental impact.

Planting has continued, however, because the judge, Jeffrey S. White, has not yet ruled on a remedy. A hearing on the matter is scheduled for July 9. The Supreme Court’s decision makes it highly unlikely that he will issue a blanket ban on the growing of the genetically engineered beets.

The decision could also sway environmental law in general. Organizations like the National Association of Home Builders and the American Petroleum Institute had filed friend-of-the-court briefs supporting Monsanto, while environmental groups as well as the states of California, Oregon and Massachusetts had weighed in on the side of the Center for Food Safety.

Mr. Snively of Monsanto said the decision made it clear that courts must meet the same strict test in granting injunctions in environmental cases as in other cases. But Nathaniel S. W. Lawrence, an attorney for the Natural Resources Defense Council, said the decision also contained wording that would make it easier in some instances for lawsuits to be filed in cases of possible environmental dangers.

Roundup Ready alfalfa and sugar beets were the newest additions to Monsanto’s extremely successful lines of Roundup Ready soybeans, corns and cotton.

The crops contain a bacterial gene that allows them to withstand spraying with Roundup or its generic equivalents, known as glyphosate. That allows farmers to spray their fields to kill weeds while leaving the crop intact, making weed control easy.

The environmental groups and others had said that the foreign gene might spread to organic or conventional nongenetically engineered crops, hurting sales of organic farmers or exports to countries like Japan that did not want genetically engineered varieties.

Court Upholds Verdict

The Supreme Court rejected Pfizer’s appeal of a verdict for an Arkansas woman, Donna Scroggin, who blamed the company’s menopause drugs for her breast cancer, leaving intact a $2.7 million award that may grow with punitive damages.

The justices let stand on Monday a lower court decision upholding that award, which was the first federal verdict against Pfizer’s Wyeth unit over its Prempro hormone-replacement treatment.

The appeal by Wyeth and Pfizer’s Upjohn unit sought to leverage a different part of the appeals court ruling ordering a new trial on punitive damages, which a jury had set at $27 million. Pfizer argued that the new trial should cover all aspects of the case, including the jury’s finding that the drugs had helped cause Ms. Scroggin’s cancer.