Fwd: [Food-news] GE salmon: FDA to approve Transgenic Fish by 2008?

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>

> [Food-news] GE salmon: FDA to approve

> Transgenic Fish by 2008?

>

> *w**ww.foodnews.ca*

>

> *Policy Gap and Confirmation: *This article reports

> on Aqua Bounty, a

> U.S. company seeking FDA approval for its breed of

> salmon, which grows

> twice as fast as conventional farmed salmon. If the

> application

> succeeds, it will be the first transgenic animal

> approved by the FDA for

> human consumption.

>

> Aqua Bounty had been looking to list on the London

> Alternative

> Investment Market (AIM) to avoid tighter U.S.

> regulations. The tighter

> regulatory regime in the U.S has dramatically

> increased the costs of

> listing for small and mid-sized firms, but has also

> squeezed out some

> bad actors who don't live up to modern standards of

> governance and due

> diligence. On March 15, 2006 Aqua Bounty announced

> that it had a

> successful placing of common shares on the AIM.

>

> The Aqua Bounty case reveals two important food

> security issues. First,

> it indicates that innovations in the fish industry

> are coming quickly

> (the 'AquAdvantage " fish is scheduled for launch in

> 2009). Second, it

> shows the failure of the market to regulate global

> fisheries, and the

> need for global standards on and popular governance

> of food policy. The

> inability of stock markets to address issues of food

> security such as

> due diligence, liability and conflict of interest,

> and the ability of

> companies to shift authority to low regulatory

> arenas within the private

> as well as public sectors, highlight the need for

> global as well as

> national food policies and regulations.**BM*

>

>

> Check Biotech, 10th January 2006

> http://www.checkbiotech.org

> *

> Salmon growing up fast*

>

> If Elliot Entis can win FDA approval for his

> quick-growing fish, he'll

> pave the way for other food companies working on

> genetically modified

> animals.

>

> Elliot Entis doesn't much like to think of himself

> as a pioneer. And

> aside from a single framed photo of a salmon hanging

> on the wall, Entis'

> tiny office in Waltham, Mass., offers barely a hint

> of what has been a

> labor of love since 1992. His company, Aqua Bounty

> Technologies, has

> created a breed of salmon that grows twice as fast

> as normal farmed

> salmon, because they carry part of the genetic code

> of another type of

> fish, the ocean pout.

>

> Aqua Bounty is in the final stages of a five-year

> battle to get the

> product approved by the Food & Drug Administration,

> which has yet to

> approve any transgenic animal for human consumption.

> If the company

> succeeds, Entis' salmon could become the first such

> product on the

> market. He hopes to achieve that milestone by 2008.

>

> TOUGH QUESTIONS

>

> Entis' salmon grow so fast because of a change made

> to one of the

> roughly 40,000 genes in their DNA. In normal salmon,

> the gene that

> controls the production of growth hormone is

> activated by light, so the

> fish generally grow only during the sunny summer

> months. But by

> attaching what's known as a " promoter sequence " --

> part of a specific

> gene -- from the pout, Aqua Bounty ended up with

> salmon that make growth

> hormone all year round.

>

> These genetically modified fish won't look or taste

> any different to

> consumers, but they could make an ocean of

> difference to fish farmers.

> Entis estimates they'll allow the average salmon

> producer to cut costs

> 35% per fish while doubling output. " It's like

> improving the mileage in

> your car, " he explains.

>

> While it may sound simple, the FDA has come up with

> a litany of tough

> questions for Entis. The agency has asked for a

> complete description of

> the transgene, a map of exactly where it sits in the

> salmon's

> chromosome, and proof that the location of the

> tweaked gene won't change

> as it's passed down from generation to generation.

> The agency needs that

> information to ensure consistency in the final

> product and to guarantee

> that the fish remain healthy.

>

> MATING SEASON

>

> Aqua Bounty's toughest challenge has been to allay

> fears that if the

> supersalmon escape into the ocean, they could start

> mating with their

> wild counterparts, ultimately wiping out the world's

> entire population

> of wild salmon. The company may decide only to seek

> approval for sterile

> fish or for fish that are grown indoors -- making

> such scenarios

> impossible. Still, to answer concerned

> environmentalists, AquaBounty has

> been collecting data that predict what might happen

> if their fish escaped.

>

> Some studies, including independent research done at

> Purdue University,

> use a combination of controlled experiments with

> laboratory fish and

> mathematical modeling to determine what

> characteristics a genetically

> modified fish would need to have to overtake wild

> populations. For one,

> male transgenic fish would need to be bigger than

> wild salmon to gain

> any advantage during mating season.

>

> AquaBounty's fish grow faster, but not bigger, than

> regular salmon, and

> they're all female anyway. All in all, says Entis,

> " our fish would be

> lousy survivors [in the wild]. " The company predicts

> that fewer than 1%

> of genetically modified salmon that escape would

> survive to adulthood in

> the wild.

>

> SCRAPING BY

>

> As is the case with most new ideas in biotech,

> though, some critics

> remain unconvinced. Jeremy Rifkin, president of the

> Foundation of

> Economic Trends in Washington, D.C., and a longtime

> critic of genetic

> modification, is afraid that mixing up genes from

> different species

> could have unpredictable consequences over the long

> run.

>

> " We know genes cross borders, but what we have here

> is a radical

> speeding up of that journey, " he says. " We're

> introducing so many

> radical changes into the physiology of the

> ecosystem. The environmental

> implications could be enormous. "

>

> If the pioneers of genetically modified meat fail to

> allay such fears,

> heir inventions may face a tough marketing

> challenge. Entis says the

> fish farmers who would ultimately adapt Aqua

> Bounty's technology are

> reluctant to commit to it until the FDA weighs in.

> The privately held

> company is scraping by on funding from private

> investors, as well as

> revenues from other fish-related products. But other

> inventors of

> genetically modified food are desperate for

> financial support from meat

> producers, and they're coming up empty-handed. Three

> scientists at the

> University of Guelph in Ontario, Canada, for

> example, have been looking

> for a financial partner to help bring a new type of

> pig through the

> regulatory process and to market.

>

> COSTLY ENZYME

>

> Their Enviropig has been genetically modified to

> produce less

> phosphorous in its manure than normal pigs do. The

> creature could solve

> one of the biggest environmental threats in modern

> agriculture: so many

> pigs producing so much phosphorous that the chemical

> is building up in

> soil and running off into groundwater.

>

> Pork producers cut the phosphorous output by feeding

> pigs an enzyme

> called phytase, which chews up some phosphorous

> while it's still in

> their stomachs. But adding phytase can be costly.

> Enviropigs are born

> with the ability to produce phytase naturally in

> their saliva.

>

> Still, the fears about genetic modification seem to

> outweigh the

> near-universal consensus that the pork industry

> needs to fix the

> phosphorous problem. " What we're hearing from large

> producers is they

> don't want their trademarks tainted with genetically

> modified animals

> because consumers aren't ready for it, " said Cecil

> W. Forsberg,

> professor of microbiology at Guelph and one of the

> Enviropig's

> inventors, in an interview at the annual meeting of

> the Biotechnology

> Industry Organization.

>

> FACT VS. MYTH

>

> He fears that if they can't raise money to advance

> the project soon,

> the Enviropig will become an endangered species. " In

> view of the

> increasingcost of energy, which [increases] the cost

> of adding phytase

> enzyme to the pig ration, we would like to think

> that the industry will

> begin showing interest in pigs that bypass the need

> for the third most

> expensive nutrient in their diet, " he griped in a

> follow-up e-mail.

>

> To win the confidence of consumers, pioneers of

> transgenics will have to

> educate the public on the facts vs. the myths of

> genetic modification.

> Entis is trying to do his part. Whenever he hears

> someone say

> " genetically modified, " he urges them to use the

> term " advanced hybrid "

> instead. His reasoning: Crossing a salmon with a

> pout is really no

> different from selectively breeding desirable traits

> into cows to make a

> tastier prime rib. There are plenty of examples in

> the fish industry as

> well. The sunshine bass, for example, is a cross

> between a fresh water

> white bass and salt water striped bass.

>

> " I can tell you, they don't meet in nature, " Entis

> says. " That's

> crossing the species barrier. " ROAD MAP Like many

> entrepreneurs in the

> field of transgenics, Entis is eagerly awaiting the

> FDA's guidance on

> milk and meat derived from cloned animals. The

> agency is expected to

> declare that products from cloned animals are safe,

> and that could

> provide a boost of confidence for

> transgenics-derived foods. If Entis

> succeeds in gaining the FDA's confidence, he plans

> to release all the

> data from the studies his company conducted to get

> the approval -- in

> the hopes it will provide a road map for other

> companies working on

> transgenic animals.

>

> Aqua Bounty is now completing what Entis believes

> will be the final

> major study it needs to do to meet the FDA's

> food-safety requirements.

> The study is designed to prove the modified fish

> don't touch off

> allergic reactions any more than normal salmon do.

> Entis says he has

> come to accept the long approval process. " We want

> the public to accept

> this, and they won't if there's not an air-tight

> review. " That review

> will likely pave the regulatory pathway for all the

> transgenics critters

> yet to come.

>

> Source or related URL: http://www.checkbiotech.org

> <http://www.checkbiotech.org/

>

>

> **Bruce Mackenzie is a Contributing Editor to

> Foodnews*.

>

> --

>

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