[Lillie_Steins]

BY HELENA BOTTEMILLER | SEP 30, 2010

As a federal regulatory panel mulls over whether to approve genetically modified salmon for human consumption, a new effort to require labeling for the engineered fish is afoot.

Rep. Rosa DeLauro (D-CT), chairwoman of the House committee that controls the U.S. Food and Drug Administration and Department of Agriculture budgets, introduced a bill Wednesday that would mandate labeling of genetically modified fish.

According to her office, DeLauro's Consumers Right to Know Food Labeling Act would also require USDA to mandate that products of cloned animals be labeled, if intended for human consumption.

"A recent Food & Water Watch survey revealed that 78 percent of Americans do not want genetically-engineered salmon to be approved and made available in stores and restaurants," said DeLauro in a statement. "It is obvious that the American public wants to be able to make informed decisions when purchasing their food and that they want to be able to differentiate cloned or genetically modified products from natural products."

"Because the FDA is treating these genetically modified salmon not as a food issue but as an animal drug issue, current regulations would leave the consumers unable to discern between these new modified salmon and traditional salmon," she added. "If FDA approves the genetically modified salmon the American public deserves to know the truth about their food, and this legislation will ensure that they are provided with this critical information."

[Srewxardsasv]

FDA rules won't require labeling of genetically modified salmon

By Lyndsey Layton
Saturday, September 18, 2010

As the Food and Drug Administration considers whether to approve genetically modified salmon, one thing seems certain: Shoppers staring at fillets in the seafood department will find it tough to pick out the conventional fish from the one created with genes from another species

Despite a growing public demand for more information about how food is produced, that won't happen with the salmon because of idiosyncracies embedded in federal regulations.

The FDA says it cannot require a label on the genetically modified food once it determines that the altered fish is not "materially" different from other salmon - something agency scientists have said is true.

Perhaps more surprising, conventional food makers say the FDA has made it difficult for them to boast that their products do not contain genetically modified ingredients.

The labeling question has emerged as the FDA determines whether to approve the fish, an Atlantic salmon known as AquAdvantage that grows twice as fast as its natural counterpart. The decision carries great weight because, while genetically modified agriculture has been permitted for years and engineered crops are widely used in processed foods, this would be the first modified animal allowed for human consumption in the United States.The AquAdvantage salmon has been given a gene from the ocean pout, an eel-like fish, and a growth hormone from a Chinook salmon.

'The public wants to know'

Consumer advocates say they worry about labeling for genetically engineered beef, pork and other fish, which are lining up behind the salmon for federal approval.

"The public wants to know and the public has a right to know," said Marion Nestle, a professor in the Nutrition, Food Studies and Public Health Department at New York University. "I think the agency has discretion, but it's under enormous political pressure to approve [the salmon] without labeling."

The debate will be taken up this week, with an advisory committee meeting Sunday and Monday on whether to allow the modified fish, and a separate panel meeting Tuesday on whether the fish should be labeled. The panels will offer recommendations to the FDA commissioner, who will decide both matters.

The biotechnology industry is opposed to mandatory labeling, saying it will only bewilder a public that is not well informed about genetic engineering.

"Extra labeling only confuses the consumer," said David Edwards, director of animal biotechnology at the Biotechnology Industry Organization. "It differentiates products that are not different. As we stick more labels on products that don't really tell us anything more, it makes it harder for consumers to make their choices."

The FDA defends its approach, saying it is simply following the law, which prohibits misleading labels on food. And the fact that a food, in this case salmon, is produced through a different process, is not sufficient to require a label.

The controversy comes at a time when Americans seem to want to know more about their food - where it is grown, how it is produced and what it contains. Books criticizing industrial agriculture have become bestsellers, farmers markets are expanding and organic food is among the fastest-growing segments of the food industry.

The FDA itself is part of a new effort to improve nutrition information on processed foods.

FDA rules won't require labeling of genetically modified salmon

In the European Union and Japan, it is nearly impossible to find genetically modified foods, largely because laws require labeling, said William K. Hallman, director of the Food Policy Institute at Rutgers University. "No one wants to carry products with such a label," he said. "The food companies figure that consumers won't buy it."

There is nothing to stop salmon producers or food makers in the United States from voluntarily labeling their products as genetically engineered - except a fear of rejection in the marketplace, Hallman said. "I don't know of a single company that does that," he said.

The FDA maintains it can only require labeling if a genetically engineered food is somehow different from the conventional version - if it has an unusual texture, taste, nutritional component or allergen, for example.

Although some consumer advocates maintain there are important differences, the agency's scientists have already said they see no "biologically relevant" variations between the AquAdvantage salmon and traditional salmon.

Consumers could be certain of getting the non-modified version if they bought salmon labeled as "wild," but most salmon consumed in this country is farmed.

Ever since the FDA approved the first genetically altered material for use in food in 1992, when Monsanto developed a synthetic hormone injected into cows to increase milk production, the agency has held that it cannot require food producers to label products as genetically engineered.

In the intervening years, the use of genetically engineered crops has skyrocketed; 93 percent of this year's soybean crop is genetically engineered, according to the U.S. Agriculture Department.

Byproducts of those crops - soy lecithin, for example - are found in thousands of processed foods from chocolate bars to breakfast cereal; none is labeled as containing genetically modified ingredients.

No 'Hormone Free' either

The labeling matter is further complicated because the FDA has maintained a tough stance for food makers who don't use genetically engineered ingredients and want to promote their products as an alternative. The agency allows manufacturers to label their products as not genetically engineered as long as those labels are accurate and do not imply that the products are therefore more healthful.

The agency warned the dairy industry in 1994 that it could not use "Hormone Free" labeling on milk from cows that are not given engineered hormones, because all milk contains some hormones.

It has sent a flurry of enforcement letters to food makers, including B&G Foods, which was told it could not use the phrase "GMO-free" on its Polaner All Fruit strawberry spread label because GMO refers to genetically modified organisms and strawberries are produce, not organisms.

It told the maker of Spectrum Canola Oil that it could not use a label that included a red circle with a line through it and the words "GMO," saying the symbol suggested that there was something wrong with genetically engineered food.

"This to me raises questions about whose interest the FDA is protecting," said Rep. Dennis J. Kucinich (D-Ohio), who has introduced legislation that would require labeling for genetically engineered food. "They are clearly protecting industry and not the public."

One state with a sizable salmon fishing industry - Alaska - passed a law in 2005 that requires labeling of any genetically engineered fish sold there.

"One side of the argument says let's give consumers sovereignty over their food choices," Hallman said. "The other says we've done the science on this and it's no different, so if we put a label on it, we're implying it's somehow risky and that's like government imposed false advertising."

[DiatryDal]

Another article on the subject.

By Associated Press WriterAssociated PressMonday, September 20, 2010

Tinker with the genetics of salmon and maybe you create a revolutionary new food source that could help the environment and feed the hungry.

Or maybe you're creating what some say is an untested "frankenfish" that could cause unknown allergic reactions and the eventual decimation of the wild salmon population.

The Food and Drug Administration hears both arguments Monday when it begins a two-day meeting on whether to approve the marketing of the genetically engineered fish, which would be the first such animal approved for human consumption. The agency has already said the salmon, which grows twice as fast as conventional salmon, is as safe to eat as the traditional variety.

Approval of the salmon would open the door for a variety of other genetically engineered animals, including an environmentally friendly pig that is being developed in Canada or cattle that are resistant to mad cow disease.

"For future applications out there the sky's the limit," said David Edwards of the Biotechnology Industry Association. "If you can imagine it, scientists can try to do it."

AquaBounty submitted its first application for FDA approval in 1995, but the agency decided not until two years ago to consider applications for genetically engineered animals ? a move seen as a breakthrough by the biotechnology industry.

Genetic engineering is already widely used for crops, but the government until now has not considered allowing the consumption of modified animals. Although the potential benefits ? and profits ? are huge, many individuals have qualms about manipulating the genetic code of other living creatures.

Genetically engineered ? or GE ? animals are not clones, which the FDA has already said are safe to eat. Clones are copies of an animal. With GE animals, their DNA has been altered to produce a desirable characteristic.

In the case of the salmon, AquaBounty has added a growth hormone from a Chinook salmon that allows the fish to produce their growth hormone all year long. The engineers were able to keep the hormone active by using another gene from an eel-like fish called an ocean pout that acts like an on switch for the hormone, according to the company. Conventional salmon only produce the growth hormone some of the time.

In documents released ahead of the hearing, the FDA said there were no biologically relevant differences between the engineered salmon and conventional salmon, and there is a reasonable certainty of no harm from its consumption.

Critics have two main concerns: The safety of the food to humans and the salmon's effect on the environment.

Because the altered fish has never been eaten before, they say, it could include dangerous allergens, especially because seafood is highly allergenic. They also worry that the fish will escape and intermingle with the wild salmon population, which is already endangered.They would grow fast and consume more food to the detriment of the conventional wild salmon, the critics fear.

A wide range of environmental, food safety and consumer groups have argued that more public studies are needed and the current FDA process is inadequate because it allows the company to keep some proprietary information private. Modified foods are regulated under the same process used for animal drugs.

"It is outrageous to keep this vital information secret," said Wenonah Hauter, director of the advocacy group Food & Water Watch. "Consumers have a right to know what FDA is trying to allow into our food supply."

Dr. Michael Hansen, senior scientist at Consumers Union, the publisher of Consumer Reports, says the agency is relying on too little data, much of which is supplied by the company itself.

"FDA has set the bar very low," he said.

Ron Stotish, the chief executive of AquaBounty, countered that the company has more than addressed the concerns, and his product has come under much more scrutiny than most food.

"This is perhaps the most studied fish in history," he said. "Environmentally this is a very sustainable technology."

The company has several safeguards in place to allay concerns. All the fish would be bred female and sterile, though a small percentage may be able to breed. They would be bred in confined pools where the potential for escape would be very low.

In its environmental analysis of the fish released earlier this month, the FDA agreed with the company that there are enough safeguards in place.

Stotish says the fish would be bred in better conditions than many of the world's farmed salmon, and could be located closer to population centers to help feed more people. The company has also said the increase in engineered salmon production could help relieve endangered wild salmon populations.

The company is also arguing that the fish do not need to be labeled as genetically engineered, so the common customer would not know if they were eating the modified product or the conventional product. The second day of the FDA meeting will focus on the labeling question.

"This fish is identical to the traditional food," maintained Stotish. "The label could even be misleading because it implies a difference that doesn't exist."

At the meeting Monday, the FDA, the company and critics will present their findings to an advisory committee, which will in turn advise the FDA. A decision will come after the meeting, though it is unclear how long that will take. If approved, the fish could be in grocery stores in two years, the company estimates.

The industry says their job will be to counter the common impression that the modified salmon are "frankenfish."

"In the story of Frankenstein it was the fear of the people driving it, it wasn't the monster that was evil," says Edwards of the Biotechnology Industry Association. "If you look at the science and the safety and you look at the benefits, they become very exciting products."

___

Online:

Background on FDA meeting: http://tinyurl.com/ylp5ccv

[Blaxastij]

I read about this yesterday and I hope that the FDA won't give them a free pass. Nobody can predict the long-term implications to our health, eating this fish, so why not lable it and let us decide.

I am really upset about this. Where is it going to stop?

[herrdwq]

It's very creepy to me.

[sasaderesada]

At least a few senators seem to be questioning what the FDA is doing with Frankenfish. A label seems to be a small request that the FDA should require. Something smells fishy to me.


By Lyndsey Layton
Washington Post Staff Writer
Tuesday, September 28, 2010

Eleven senators, mostly from coastal states, urged the Food and Drug Administration Tuesday to stop moving forward with the approval process for a genetically modified Atlantic salmon.


Senators want review of modified salmon ended

http://views.washingtonpost.com/post...T2010090602742
Consumer groups push for label for modified salmon
http://www.washingtonpost.com/wp-dyn...092100448.html

Led by Sen. Mark Begich (D-Alaska), the senators complained to FDA Commissioner Margaret A. Hamburg that the agency is using the wrong process for evaluating the safety of the modified fish and that the public is being left out.

The fish, named the AquAdvantage salmon by the biotech company seeking federal approval to market it, is an Atlantic salmon that has been given a growth hormone from a Chinook salmon and a gene from an eel-like ocean pout, which allows it to grow twice as fast as a wild Atlantic salmon. It would be the first genetically modified animal approved for human consumption in the United States.

Begich said the FDA is incorrectly treating the request for approval of AquAdvantage salmon as if it were a new veterinary drug and not as a new animal that humans consume. Under the current process, the company is allowed to keep private some of the data it submits to the FDA on the grounds that it is classified business information.

Serious health and environmental questions regarding the fish cannot be adequately evaluated by the public, Begich wrote.

Other senators who signed the letter were Lisa Murkowski (R-Alaska), Patty Murray (D-Wash.), Bernard Sanders (I-Vt.), Maria Cantwell (D-Wash.), Ron Wyden (D-Ore.), Patrick J. Leahy (D-Vt.), Kirsten Gillibrand (D-N.Y.), Barbara Mikulski (D-Md.), Jeff Merkley (D-Ore.) and Jon Tester (D-Mont.).

An agency spokeswoman said the FDA will "respond directly to the members of Congress."

http://views.washingtonpost.com/post...T2010090602742

Here's another article indicating that many in Congress are getting on board with this issue.

http://truefoodnow.org/2010/09/29/th...lmon-approval/