Genetically Engineered Salmon Safe or Dangerous

Genetically Engineered Salmon Safe or Dangerous
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A compilation of articles by Sharon the Founder of STSSA
This is a new genetically made animal. And the hearing was held today with very short public notice. And those opposed only had 3 minutes, got rushed through and cut off. But you can still comment to the FDA with the info provided below in the 4th section.
Sharon Kitchen
Founder Save The Sacred Sites Alliance
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Consumer Groups and Public Protest FDA Plan to Approve First Genetically Engineered Food Animal
http://ge-fish.org/2010/09/16/consumer-groups-and-public-protest-fda-plan-to-approve-first-genetically-engineered-food-animal/
Posted on September 16, 2010 by Heather
FDA Appears Poised to Continue with its Biotech Bailout while Consumers are Left in the Dark
On Thursday, at a press conference and rally outside of the White House, the Center for Food Safety, Food & Water Watch, Friends of the Earth, and the CEO of Ben & Jerry’s demanded the Obama Administration halt FDA approval of the first genetically engineered (GE) food animal. The FDA is expected to decide whether to approve the controversial GE salmon, created by a company called AquaBounty, at a series of hearings this Sunday through Monday.

“The FDA is functioning more as a stock promoter for the biotech industry than a guardian of public health,” said Jaydee Hanson, Senior Policy Analyst at the Center for Food Safety. “Approval of this fish cuts a gaping hole in public safety and seems intended to help the biotech industry raise capital for other GE animals.”

Over 300 environmental, consumer, health, and animal welfare organizations, along with salmon and fishing groups and associations, food companies, chefs and restaurants signed joint letters to the FDA opposing the approval of AquaBounty’s GE salmon. As of Thursday, a coalition of groups including the Center for Food Safety, Food & Water Watch, Friends of the Earth, The Organic Consumers Association, Food Democracy Now and CREDO Action, among others, had collected over 160,000 consumer comments to submit to the FDA and President Obama, urging them to reject the approval of genetically engineered salmon. In addition, 14 members of the California State Legislature sent a letter to FDA and President Obama requesting that FDA deny the approval until the full suite of environmental and food safety concerns are addressed.
Check out images of the rally and press conference on our Flickr page
The groups revealed the environmental and consumer risks that would be introduced by the salmon, as well as their concerns with an approval process that, they say, is designed to limit public knowledge and participation. They disclosed that:
Despite AquaBounty’s claim to produce only sterile fish, up to 5 percent of its GE salmon eggs could be fertile (and could therefore breed with wild populations), prompting the FDA to label its claims “potentially misleading.”
AquaBounty has claimed it has already received orders for 15 million eggs — 750 thousand of which could be fertile.
The FDA has no rules requiring that AquaBounty, and the thousands of fish farmers who would receive their product, raise the GE fish on land. Millions of farmed salmon escape into the wild each year. Approximately 6 months ago, 10 thousand escaped from a UK farm due to one hole in a net.
No long-term or independent studies have been conducted to assess the human health risks associated with eating transgenic fish. In assessing the impact of GE salmon on consumers and the environment, the FDA admitted that primary deference was given to studies submitted by AquaBounty Technologies – the company producing the salmon.
The principle study the company conducted to test possible allergic reactions involved just six of the GE fish intended for human consumption.
At this time, AquaBounty’s financial survival depends on FDA’s approval of GE salmon. The company has invested $50 million in the product, while posting zero sales and almost five million dollars in net losses in 2009. Its stock price plummeted to near zero in 2008 and only began to rise this summer after FDA announced its plan to approve the fish.
The FDA released what the groups called an insufficient amount of public information for review only ten days before public hearings scheduled to determine whether or not to approve the fish.

Dave Love, PhD, Project Director with Johns Hopkins Center for a Livable Future said, “The results of two non-peer-reviewed, confidential studies and one study nearly 20 years old are not adequate for the public to decide the allergenicity and toxicity of genetically engineered farmed salmon. The three major problems with these existing salmon foods safety studies are their small sample sizes, short durations and low quality.”

“Until more high-quality, long-term studies are performed demonstrating safety for consumers and for the ecosystem, there is not enough information to make an evidence-based decision on whether genetically engineered salmon are safe to consume,” Love said.

“It’s looking like the FDA will approve the salmon in the next few days unless consumers speak out to stop them,” said Wenonah Hauter, Executive Director of Food & Water Watch. “Unfortunately, the FDA has kept the public in the dark about the decision-making process. The clock is ticking, which is why we’re calling on the Obama Administration to halt the process before this science experiment ends up on our plates.”

The decision to approve the salmon could have larger implications for the widespread approval of GE foods. AquaBounty has additional plans to produce GE trout and tilapia. Other companies are currently developing GE pigs and cows.

“The FDA must deny approval of this modified fish to protect the environment, public health, fishing communities, and biodiversity,” said Eric Hoffman, Biotechnology Policy Campaigner with Friends of the Earth.

A 2009 Consumer Reports poll revealed that the majority of consumers would not eat genetically modified food, while a Washington Post poll conducted earlier this month revealed that nearly 80 percent would not eat GE salmon.

Ben & Jerry’s announced at the event that it symbolically changed the name of its ‘Phish Food’ ice cream to ‘Something’s Fishy’ to protest the approval of genetically engineered food animals.
Consumers can send a comment to FDA through the Center for Food Safety’s website here.
OR call the White House today to support the Day of Action
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The Center for Food Safety is a national, non-profit, membership organization founded in 1997 to protect human health and the environment by curbing the use of harmful food production technologies and by promoting organic and other forms of sustainable agriculture. CFS currently represents over 125,000 members across the nation.
The Center for Food Safety’s Fact Sheet on GE fish is available here; other background and campaign materials available at www.ge-fish.org
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Genetically engineered salmon for dinner anyone?
http://ecowomen.net/tag/aqua-bounty-technology/
Posted on September 14, 2010
by ecoguestToday, the Eco Women welcome Eco Karen,
who is posting about a rather scary issue.
If the FDA approves it on September 20th** —
just six days from now — genetically engineered (GE) salmon will soon be available for you to serve for dinner. That’s right, in just 18 months, you could be eating FRANKENFISH!

(** See below for undated info on hearing dates.)

Wait. You don’t like salmon? You hate fish? Oh…this is not just about salmon. It’s about biotechnology. It’s about fooling with nature. It’s about our food supply. It’s not just about the GE salmon itself but a bigger issue with this technology. It may apply to you too. Read on.

What does this mean?
I heard about GE salmon or “frankenfish” that Aqua Bounty Technology (ABTX on London’s Stock Exchange) was trying to push the FDA to approve back in August. I scoffed at the idea because, I naively thought, “Pffft. Who, in their right mind in our government would approve this?” Man, I couldn’t have been more wrong! I’ll get to the actual franken-salmon thing later, but the FDA is actually considering approving this technology? To “invent’ new species for us to consume as food…to create a brand new species for us to eat, because you know, we are “running out of food” to eat?

Do you know what this means? I am afraid that, if approved, this technology will entice other industries, if not already, to aggressively invest millions of dollars into developing genetically engineered meatslike cows, pigs, chickens, lambs, and what else? Do I foresee even ‘genetically engineered humans’ for our future consumption? Or how about just a chunk of meat-looking-thing for sale in the meat section at your local supermarket? That is totally disgusting and wrong on so many levels that I cannot believe I even typed the words here. It makes me nauseous even thinking about it. But you know what? I thought that back in August about this salmon! This is a total “Brave New World” we live in! It’s bad enough that we are dealing with GMO’s in foods that sneak into cereal boxes and cookies that we feed to our kids. And now, we will be eating fish fillets that are laden with growth hormones and two different species of fish that were bred and then forced to grow twice the size of a normal fish?

OK. Before I pop another vein, let me tell you some facts that we are “allowed” to know….because, you know, some things are, ummm….. “p.r.o.p.r.i.e.t.a.r.y.” *air quoting and rolling eyes in disgust*

What are the facts? (my thoughts in italics):

Aqua Bounty Technology (ABTX) or Aqua Advantage® based in Waltham, MA has invested 50 million dollars in the last 14 years to come up with this transgenic technology and is in line to make millions more, if not billions, if the FDA approves.
Transgenic or genetically engineered salmon has combined genes from Chinook salmon (to produce growth hormone) and eel-like, ocean pout (to produce antifreeze protein), which will make GE salmon produce growth hormone ALL THE TIME. Normally, salmon produces growth hormones only during the warmer weather and the production turns off during the cold temperatures, hence, longer time for it to grow to its adult size. But frankenfish will grow bigger in half the time, like in 18 months vs. 3 years. (Yielding more money faster for the bang!)
Purdue University and the National Academy of Sciences report that transgenic fish released into the ocean can threaten the natural habitat and destroy the natural population to extinction. (Because frankenfish would be more aggressive and take away the food supply from other fish. And although ABTX says GE salmon are sterile and will not be able to escape, Purdue University indicated that farmed salmon escape and get released into the wild all the time and GE salmon will create a new species altogether when the supposedly sterile females mate in the wild. How many times have we witnessed botched science experiments? Are they willing to guarantee that ALL of them will be STERILE? I don’t think so.)
ABTX has been testing the same technology in trout and arctic char in its Prince Edward Island farm facility. (And what else are they experimenting with? I read somewhere shrimp are also being used for this purpose.)
The FDA has ONLY data from ABTX for this approval process. (Isn’t that kind of unethical? Conflict of interest, anyone? Why don’t they consider other research findings, like Purdue University’s too?)
The FDA’s 60 day public notice period ends on September 20th with an actual public hearing (see the details below) — a period when we are allowed to voice our opinions through oral presentation (apply to present by September 16th), e-mails, and phone calls. (How sneaky are they to keep the public in the dark and give us only 60 days to respond when it took ABTX years to prepare for this big shebang?)
Why am I opposed to genetically engineered salmon?
I’m sorry but genetically engineered a.n.y.t.h.i.n.g. is not what I want to put in my body nor into my family’s bodies, hence my opposition to Monsanto. I’m not a geneticist or a veterinarian but there is something wrong with a grotesquely large man-made fish that was bred from two different species. Although I don’t eat that much fish anymore, when I do, I don’t want to wonder if it’s the real thing or some scientific experiment. And how about my kids? How much of this type of scientifically-invented petri dish foods will they eat throughout their lives when we are starting to feed them now? What will happen to their own genes and health of their bodies when they are at our age? How will their cells respond to all the genetically-manipulated proteins and hormone-laden foods they’ve eaten all these years?

Sure, the company says the GE salmon is just like the real salmon and there’s no difference in the nutrients and taste. But how about their protein make-up? Their genetic make-up? The company says even the genetic make-up is the same but didn’t they say that they used TWO different genes from TWO different species of fish? How could the genetic make-up be the same as the Chinook salmon?

What do you think?
Would you eat this fish? Would you eat anything that was grown with this type of technology? It’s not happening just to fish. It’s happening with corn, soy, barley, and on produce farms right now. But these are still considered as experiments. There are no long term effect studies on humans ingesting these types of animal foods. Even the scientists at Purdue University agree on this.

Still not sure? How about this analogy, then? Sports. If this was a sporting event, — unlike to some, it’s not a life-and-death situation like eating, in my book — steroids and growth hormones would definitely be considered as disqualifying factors. Are they not? I mean, didn’t Roger Clemens just get indicted for perjury for lying about steroid use while playing for the Yankees? Didn’t athletes get their medals taken away from the Olympics because of doping? How is it that it’s NOT OK for athletes to use performance enhance drugs but we can ingest them from foods?

My last words…
My husband’s family is from the Pacific Northwest. People from the Northwest are very proud of their forests and their fishing. There is no substitute for wild caught Alaskan King or Chinook or Coho salmon. The annual salmon runs are big events in town. More people have salmon smokers in their backyards than BBQ grills. There are fish hatcheries where they help salmon to hatch and release the young into the wild. (Why can’t they improve on this technology to increase salmon population and not GE technology?) I used to be able to go to a nearby fishing dock and buy the freshest, just caught salmon, right off the boat. It’s not so easy anymore. The salmon population has been dwindling. However, I think those fishermen who might be suffering will still tell you that even with the dwindling supply, genetically altered salmon is sacrilegious and is not the answer to the shortage. Even though ABTX claims to have solved the salmon shortage problem with the technology, it will actually kill the salmon industry, wild or farmed, because people, like myself, will be skeptical of eating ANY salmon since these GE salmon will not be labeled as such. And how about destroying biodiversity and affecting the wild and natural salmon? Would I want to eat wild salmon, then?

So what can you do?
Let me leave you with links where you can read more on this issue.

Watch this interview with Eric Hoffman of Friends of the Earth and Patty Lovera of Food and Water Watch.
Check Salmon Nation for more info on what Purdue University’s researches have found. But if you want to read the actual paper from Purdue University, click here.
Q & A from Greenpeace
Curious what GMO does? Read what Food and Agriculture Organization of the United Nations says here.
Also, if you are mad as hell like I am, here are some links where you can go and yell and holler like I did.

If you think this GE technology is outrageous, contact the FDA and let them know how you feel. http://www.fda.gov
Sign the petition and send a letter to President Obama since he really has the ultimate power in the decision making process.http://action.foodandwaterwatch.org
Send this letter to FDA Veterinary Medicine http://action.foe.org, who will investigate this application.
Share this post with all your contacts and have them yell too. Share it on your Facebook and Twitter.

Don’t take my word for it. Do your research and be scared … because, I am.

Hearing Dates: from the FDA website…

September 19th – 20th, 2010 - the committee will receive an orientation on both general scientific issues surrounding genetically engineered animals and on September 20, 2010, the Committee will consider issues regarding the safety and effectiveness of the new animal drug that is the subject of new animal drug application concerning AquaAdvantage salmon produced by AquaBounty Technologies, Inc. (http://www.fda.gov/AdvisoryCommittees/Calendar/ucm223823.htm)

Labeling issue hearing on September 21st – FDA to explain the relevant legal principles for food labeling and to solicit information and views from interested persons on the application of these principles to the labeling of food made from AquaAdvantage Salmon. (http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm222601.htm)

November 22, 2010 – Last date to submit written comments on the labeling of food made from AquaAdvantage Salmon to Docket No: FDA-2010 -N-0385, identify your comments by this docket number. Submit electronic comments to http://www.regulations.gov, or submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Many thanks to Eco Karen for her detailed analysis! The Eco Women believe this is an important issue and hope that you’ll take a couple of minutes to click the links to voice your disapproval. It’s really fast and easy and your vote could make all the difference!

Ecokaren is a green blogger, eco-crafter on Etsy, a mom to two greenagers and a wife to an accidental recycler. You can follow her onTwitter and be her friend on Facebook, if you want to. If not, that’s ok. She still likes you.

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Biotech salmon faces scrutiny at FDA panel


http://www.reuters.com/article/idUSTRE68J0EZ20100920
By Susan Heavey
ROCKVILLE, Maryland | Mon Sep 20, 2010 2:30pm EDT
(Reuters) - The first genetically modified animal could move one step closer to U.S. dinner tables on Monday, when a federal advisory panel recommends whether such food -- a salmon -- is safe to eat.

Both Food and Drug Administration staff and the salmon's maker, Aqua Bounty Technologies Inc, have said the fast-growing fish appears to be the same as normal Atlantic salmon and poses little threat to the environment or diners.

But some consumer advocates, environmentalists and others have protested the move. They say there is not enough data to show that eating the genetically modified salmon does not cause side effects such as allergic reactions or that accidental escape will not harm other fish.

If approved, Aqua Bounty's salmon would be the first genetically altered animal for human consumption in the United States. The FDA has already allowed modified animals as pets or to help produce biologic medicines. Genetically engineered vegetables such as corn have been on the market for years.

Overcoming advocates' complaints and winning the panel's support is critical for Aqua Bounty, whose shares have more than tripled this year ahead the FDA's potential green light.

The company has no other approved products and is eyeing the genetic technology for use in other fish like tilapia and trout.

Aqua Bounty Chief Executive Officer Ronald Stotish told the FDA's panel of outside experts that approval could help provide the "healthy kind of diet that Americans are used to" amid threats from overfishing and increased demand. Without it, "it's hard to imagine how we'll meet the protein needs of the developing population over the next 20 to 30 years."

The small Massachusetts-based biotechnology company said it had first sought U.S. approval of the salmon in 1995. It reported a $4.8 million net loss for last year after restructuring in 2008 to preserve cash and focus on approval.

Its shares were unchanged on the London Stock Exchange ahead of the panel's recommendation.

Later on Monday, panelists will advise the FDA if there is "reasonable certainty" that the salmon is safe to eat or if there is a potential environmental threat. The agency will weigh the recommendations before making its final decision.

INCREASED RISK?

Critics, including groups like Consumers Union, the Center for Food Safety and Food & Water Watch, say Aqua Bounty has not done sufficient studies to prove its fish is safe. They also criticize the FDA for allowing just 14 days for the public to review the data even though the company submitted its bid more than a decade ago.

Last week, various groups protested in front of the White House, urging President Barack Obama to postpone the public meeting or block the potential approval.

Consumers Union "is particularly concerned that this salmon may pose an increased risk of severe, even life-threatening allergic reactions to sensitive individuals," it said in a statement. It added that fish are already a major allergen and that "this salmon could make the problem worse."

Aqua Bounty's salmon has a gene to make it grow twice as fast as natural Atlantic salmon. The company has said it is the same in every way to wild salmon and that taste tests showed no difference.

Stotish said Aqua Bounty plans to sell the eggs to inland fish farmers. The product could eventually boost the United States' meager domestic salmon farms, he said, even though the company's first application seeks approval to grow the fish at facilities in Canada and Panama.

The United States imports more than $1 billion of Atlantic salmon a year after industrialization knocked out most wild populations in its Northeast region.

Steven Vaughn, director of the Office of New Animal Drug Evaluation at the FDA's Center for Veterinary Medicine, said it took the agency so long to bring Aqua Bounty's bid before the public because it had to grapple with how to handle the complex science.

"This has been very challenging for us as a new technology," he said.

But other genetically altered food animals, including pigs and cows, are in the works. One other engineered fish, Yorktown Technologies LP's GloFish, is already sold in the United States as a pet.

One concern is whether consumers will know when they are buying genetically modified salmon, if it is approved.

Current FDA rules only call for special labels for altered food when there is a "material difference" in the product's end result. Aqua Bounty and FDA staff both say tests show the salmon's composition appears similar to normal fish.

Special package labeling to note AquaAdvantage salmon is altered "just causes confusion for the consumers," said David Edwards, head of animal biotechnology for the Biotechnology Industry Organization, of which Aqua Bounty is a member.

The FDA's panelists will offer their advice later on Monday although there will not be a formal vote. On Tuesday, the agency will take comments on public labeling issues.

(Reporting by Susan Heavey; Editing by Stacey Joyce and Lisa Von Ahn)

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September 19-20, 2010: Veterinary Medicine Advisory Committee Meeting Announcement
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm223823.htm

Center Date Time Location
CVM September 19-20, 2010 September 19 from 1:00 pm to 5:30 pm and September 20 from 8:00 to 6:00 pm Rockville Hilton
1750 Rockville Pike
Rockville, MD 20852
301-468-1100
Agenda
On September 19, 2010, the committee will receive an orientation on both general scientific issues surrounding genetically engineered animals and the statutory and regulatory constraints under which the agency must operate. On September 20, 2010, the Committee will consider issues regarding the safety and effectiveness of the new animal drug that is the subject of new animal drug application concerning AquAdvantage salmon produced by AquaBounty Technologies, Inc. These genetically engineered Atlantic salmon are intended to grow faster than conventionally bred Atlantic salmon. Two background documents, “An overview of Atlantic salmon, its natural history, aquaculture, and genetic engineering” and “The VMAC Meeting on Science-Based Issues Associated with AquAdvantage Salmon” are posted at 2010 VMAC Meeting Materials.
In a separate notice published elsewhere in this issue of the Federal Register, FDA has announced that it will hold a public hearing on the labeling of food, including naming of the food, from the AquAdvantage salmon on September 21, 2010. This public hearing will allow the public to comment on the application of food labeling principles to food from the AquAdvantage salmon, if the NADA is approved. An overview of the labeling issues to be addressed is described in “Background Document: Public Hearing before the Commissioner on the Labeling of Food Made from the AquAdvantage Salmon”.
Meeting Materials
Links to meeting materials will be added as they become available. FDA anticipates making the meeting materials available approximately 16 days before the meeting, but in any event no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
2010 VMAC Meeting Materials
Additional information regarding CVM’s regulatory oversight of genetically engineered animals can be found at http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ GeneticEngineering/GeneticallyEngineeredAnimals/default.htm
The transcript of the meeting will be posted on FDA’s website as soon as it becomes available. Written requests for either a hardcopy or CD-ROM should be directed to the Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, Rm. 6-30, Rockville, MD 20857.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before September 16, 2010
Oral presentations from the public will be scheduled between approximately 2:45 p.m. and 4:00 p.m., September 20, 2010. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 7, 2010. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 9, 2010.
Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Aleta Sindelar at 240-276-9004 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.
Contact Information
Aleta Sindelar
Center for Veterinary Medicine (HFV-3)
Food and Drug Administration
7519 Standish Place
Rockville, MD 20855
Telephone: 240-276-9004
FAX: 240-276-9020
E-mail: aleta.sindelar@fda.hhs.gov
FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)
Code: 3014512548
Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).
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--
"When crazy people call you crazy, you know you're sane.
When evil people call you evil, you know that you are a good person.
When lairs call you a liar, you know that you are truthful.
Know who you are and don't let others tell you who you are." - Dave Kitchen