Halting the “Frankenfish” Experiment


Lawsuit Challenges Frankenfish Approval

March 31, 2016
Media contacts:
Gabriel Scott, Alaska Legal Director, Cascadia Wildlands, 907-491-0856; gscott@cascwild.org
George Kimbrell, Senior Attorney, Center for Food Safety, 571-527-8618; gkimbrell@centerforfoodsafety.org
Brettny Hardy, Earthjustice, 415-217-2142; bhardy@earthjustice.org
Dune Lankard, Center for Biological Diversity, (907) 952-5265; dlankard@biologicaldiversity.org
Lawsuit Challenges FDA’s Approval of Genetically Engineered Salmon
Coalition of Fishing, Consumer, and Environmental Groups Say First-ever Approval of Laboratory-Created Food Animal Violated Laws and Ignored Risks to Wild Salmon and Fishing Communities 
SAN FRANCISCO, CA—A broad coalition of environmental, consumer, and commercial and recreational fishing organizations today sued the U.S. Food and Drug Administration (FDA) for approving the first-ever genetically engineered (GE) food animal, an Atlantic salmon engineered to grow quickly. The man-made salmon was created by AquaBounty Technologies, Inc. with DNA from three fish: Atlantic salmon, Pacific king salmon, and Arctic ocean eelpout. This marks the first time any government in the world has approved a GE animal for commercial sale and consumption.
The plaintiff coalition, jointly represented by legal counsel from Center for Food Safety and Earthjustice, includes Pacific Coast Federation of Fishermen’s Associations, Institute for Fisheries Resources, Golden Gate Salmon Association, Kennebec Reborn, Friends of Merrymeeting Bay, Ecology Action Centre, Food & Water Watch, Center for Biological Diversity, Friends of the Earth, Cascadia Wildlands, and Center for Food Safety.
In approving the GE salmon, FDA determined it would not require labeling of the GE fish to let consumers know what they are buying, which led Congress to call for labeling in the 2016 omnibus spending bill. FDA’s approval also ignored comments from nearly 2 million people opposed to the approval because the agency failed to analyze and prevent the risks to wild salmon and the environment, as well as fishing communities, including the risk that GE salmon could escape and threaten endangered wild salmon stocks.
AquaBounty’s GE salmon will undertake a 5,000-mile journey to reach U.S. supermarkets. The company plans to produce the GE salmon eggs on Prince Edward Island, Canada. The GE salmon will then be grown to market-size in a facility in Panama, processed into fillets, and shipped to the U.S. for sale. That complicated scheme is only for the initial approval, however. AquaBounty has publicly announced plans to ultimately grow its GE fish in the U.S. rather than Panama, and sell it around the world. Despite this, FDA’s approval only considered the current plans for the far-flung facilities in Canada and Panama, leaving the risk of escape and contamination of U.S. salmon runs unstudied.
The lawsuit challenges FDA’s claim that it has authority to approve and regulate GE animals as “animal drugs” under the 1938 Federal Food, Drug, and Cosmetic Act. Those provisions were meant to ensure the safety of veterinary drugs administered to treat disease in livestock and were not intended to address entirely new GE animals that can pass along their altered genes to the next generation. The approval of the GE salmon opens the door to other genetically engineered fish and shellfish, as well as chickens, cows, sheep, goats, rabbits and pigs that are reportedly in development.
The lawsuit also highlights FDA’s failure to protect the environment and consult wildlife agencies in its review process, as required by federal law. U.S. Atlantic salmon, and many populations of Pacific salmon, are protected by the Endangered Species Act and in danger of extinction. Salmon is a keystone species and unique runs have been treasured by residents for thousands of years. Diverse salmon runs today sustain thousands of American fishing families, and are highly valued in domestic markets as a healthy, domestic, “green” food.
When GE salmon escape or are accidentally released into the environment, the new species could threaten wild populations by mating with endangered salmon species, outcompeting them for scarce resources and habitat, and/or introducing new diseases. Studies have shown that there is a high risk for GE organisms to escape into the natural environment, and that GE salmon can crossbreed with native fish. Transgenic contamination has become common in the GE plant context, where contamination episodes have cost U.S. farmers billions of dollars over the past decade.  In wild organisms like fish, it could be even more damaging.
The world’s preeminent experts on GE fish and risk assessment, as well as biologists at U.S. wildlife agencies charged with protecting fish and wildlife heavily criticized the FDA decision for failing to evaluate these impacts. FDA ignored their concerns in the final approval. 
Statements from counsel and plaintiff coalition:
“FDA’s decision is as unlawful as it is irresponsible,” said George Kimbrell, senior attorney for Center for Food Safety and co-counsel for the plaintiffs. “This case is about protecting our fisheries and ocean ecosystems from the foreseeable harms of the first-ever GE fish, harms FDA refused to even consider, let alone prevent. But it’s also about the future of our food: FDA should not, and cannot, responsibly regulate this GE animal, nor any future GE animals, by treating them as drugs under a 1938 law.”
“FDA has not answered crucial questions about the environmental risks posed by these fish or what can happen when these fish escape,” said Earthjustice attorney Brettny Hardy and co-counsel for plaintiffs. “We need these answers now and the FDA must be held to a higher standard. We are talking about the mass production of a highly migratory GE fish that could threaten some of the last remaining wild salmon on the planet. This isn’t the time to skimp on analysis and simply hope for the best.”
“Atlantic salmon populations including our endangered Gulf of Maine fish are hanging on by a thread– they can’t afford additional threats posed by GE salmon,” said Ed Friedman from Friends of Merrymeeting Bay, one of the parties who successfully petitioned to classify most Maine Atlantic salmon as endangered. “The law requires agencies like FDA, who aren’t fisheries biologists, to get review and approval from scientists with that expertise. FDA’s refusal to do this before allowing commercialization of GE salmon is not only irresponsible, it violates the law.”
“On Prince Edward Island and across Atlantic Canada, indigenous peoples, anglers and community groups are working hard to protect and restore endangered salmon populations and rivers. Genetic contamination threatens all this work and in return there is little or no economic benefit to the region,” said Mark Butler, policy director at Ecology Action Centre in Nova Scotia.
There’s never been a farmed salmon that hasn’t eventually escaped into the natural environment. Why should we believe that long term, these frankenfish won’t be the same?” asked Golden Gate Salmon Association executive director John McManus.
“Once they escape, you can’t put these transgenic fish back in the bag. They’re manufactured to outgrow wild salmon, and if they cross-breed, it could have irreversible impacts on the natural world,” said Dune Lankard, a salmon fisherman and the Center for Biological Diversity’s Alaska representative. “This kind of dangerous tinkering could easily morph into a disaster for wild salmon that will be impossible to undo.”
“FDA’s action threatens and disrespects the wild salmon ecosystems, cultures and industries that are treasured here in the Pacific Northwest and Alaska,” said Gabriel Scott, Alaska legal director for Cascadia Wildlands. “These folks think a salmon is just a packet of protein, but we in Salmon Nation know better. From Alaska to California, Americans are intimately related with diverse runs of salmon and we’ve learned their unique attributes and incredible value. We’ve worked very hard to be good stewards of our natural heritage, and refuse to allow that to be undone by one company’s irresponsible experiment.”
“The FDA has failed to adequately examine the risks associated with transgenic salmon,” said Wenonah Hauter, executive director of Food & Water Watch. “The long term effects of people eating genetically modified foods have never been adequately addressed—and this GE salmon is no exception. This fish is unnecessary, so why take the risk?”
“It’s clear that the market has rejected GE salmon despite FDA’s reckless approval,” said Dana Perls, food and technology campaigner for Friends of the Earth. “Major retailers including Costco, Safeway and Kroger won’t sell it and polls show the vast majority of people don’t want to eat it. Yet under this approval it won’t be labeled, violating our fundamental right to know what we are feeding our families.”

FDA Approves Frankenfish, Cascadians Resist

By Gabe Scott, Alaska Legal Director
CORDOVA, AK— Frankenfish may be coming to a store near you, but not if we can help it.   
Last week's decision by the Food & Drug Administration to approve Genetically Engineered Salmon for sale in the United States is hugely important. There are a lot of moving pieces and unknowns, so here’s the low-down.
What are Frankenfish? 
The fish is basically an Atlantic Salmon spliced with genes from Pacific King Salmon and a deep-sea fish to make it grow faster. A company called AquaBounty Technologies makes these fish at a facility on Prince Edward Island, just off the Fortune River in Canada. They are grown out in a land-based fish farm along a small  Pacific river in Bajo Mono, Panama. With FDA’s approval, they can now do this all commercially, and sell them as regular salmon to consumers in the United States. 
Copper river red salmon (Stillwater Science)What was Approved?
The AquaBounty operation is legally classified as a new “animal drug,” and was evaluated by the FDA Center for Veterinary Medicine. Wait, fish farming frankenfish is considered an animal drug? Yep. So there’s your first clue the government is behind the eight-ball when it comes to dealing with new biotechnologies. 
This specific approval for a few ponds in Panama is just the beginning. The decision is the first of its kind, the first time any GE animal has ever been approved for human consumption.
The “AquAdvantage” salmon line is owned by AquaBounty Technologies, which in turn is owned by the global biotech conglomerate Intrexon Corporation (“A better world through better DNA”).  Based on how the fish are designed and the company’s own statements, many observers fear that AquAdvantage salmon are destined to be raised in ocean net pens. 
In spite of pleas from consumers, FDA also determined that the fish do not need to be labeled. 
And, at the same time they approved AquAdvantage salmon, the FDA also rejected two legal petitions relating to the inadequate regulatory processes for protecting consumers and the environment. 
What is the problem with frankenfish? 
There are a myriad off issues with genetically modified food, but the core problem is that the government regulators are flying blind. Rather than squarely address risks of contamination of wild stocks, disruption of wild fish markets, or health issues for consumers, genetically engineered animals are being green-lighted under a tortured reading of obscure and out-dated regulations. 
For example, they have flatly refused to consider economic impacts of their decision. This in spite of overwhelming opposition from the salmon industry. Wild salmon economies work because the product is a green, high-value healthy food. What will happen to those markets when consumers have to worry whether the fish on their plate is a frankenfish?
The agency also refused to consider any long-term or cumulative impacts. That’s preposterous for AquAdvantage salmon. The obvious plan is for them to be raised in ocean net pens on a wide scale— the venture makes no commercial sense, otherwise. 
Because it’s a new technology, we don’t know much about how GE fish might impact the environment. But it does raise significant questions and justified fears. Among them:
  • Escaped fish interbreeding with wild salmon, trout or another species;
  • Health risks to humans;
  • Economic effects. Harming the domestic fishing industry;
  • Animal welfare.
What are we doing about it?
A lot!
Opposition to “frankenfish” has been strong, in fact almost universal, in salmon territory (largely synonymous with Cascadia). It is notable that some of the strongest opposition is coming from “Salmon Nation,” from those of us whose livelihoods and culture are intertwined with salmon. 
Cascadia is committed to using every legal tool available to stop this irresponsible decision. The bedrock environmental laws we regularly apply to timber sales, the “look before you leap” rules like the National Environmental Policy Act, are well-suited to reign in reckless projects such as this.
Other national and international organizations are actively engaged as well, notably the Center for Food Safety, Friends of the Earth, and EarthJustice. 
At the grassroots level, Cascadia and our partners Mountain Rose Herbs took a leading role in the campaign for GE-free seafood, signing up groceries to take the pledge not to sell frankenfish. You can see the list of fish suppliers who took the pledge at: http://www.foe.org/gefreeseafood 
Even our politicians have gone to bat, although so far they've failed to make any hits. The Alaska legislature passed legislation banning the fish from the Alaska, and passed a resolution specifically opposing AquAdvantage salmon. In Washington D.C. Alaska’s congressional delegation, notably Lisa Murkowski and Don Young, have been vocal and strident in opposition, introducing several pieces of legislation and conducting hearings. Senators and representatives elsewhere in the Pacific Northwest are also vocal opponents. 
Commercial fishermen have been active.  The lack of labeling especially raises fears that wild salmon markets will be affected.
Whatever the right decision about genetically modified salmon, it is an important decision. The consequences should have been thought through. That is why us Cascadians are sure to continue leading the fight to demand that our interests— that the salmon’s interests— are not ignored. 
To remain involved, here are three tips:
1. To avoid eating frankenfish, shop at suppliers who have committed not to sell them. Grocers can also take the pledge, and refuse to buy any salmon with a country of origin “Panama.” Visit http://www.foe.org/gefreeseafood to see who has taken the pledge.
2. For fishermen, processors, groceries and restaurants, knowing where your fish comes from will become more important. 
3. Help support litigation challenging frankenfish by donating to Cascadia Wildlands! Also, any Cascadia members who have spent time on Prince Edward Island, or western Panama, and are interested in helping with litigation, please be in touch with our legal director, Nick Cady, nick(at)cascwild(dot)org.
(Spawned out red salmon, Copper River. Photo origin unknown)

Opinion: Unlabeled GE salmon


by Gabe Scott, Cascadia Wildlands – for the Cordova Times

April 23, 2013
Well here is something useful. Alaskans are united in defending our wild salmon heritage against Frankenfish. From Don Young to Mark Begich, Cascadia Wildlands and Greenpeace, we are leading the fight on one of the most consequential environmental issues of our time. It's not often we're this united around such a contentious issue. I think it's creeping the bad guys out. Some accuse us of selfishly looking to protect our own bottom line. But Alaskans are united against GE salmon for good reasons.
Quick background. The biotech firm AquaBounty spliced a Pacific King salmon gene into an Atlantic salmon to make it grow faster. The F.D.A. is on the cusp of giving approval to commercially farm the things. This is a huge international deal — the first genetically modified animal approved for human consumption, by anyone, anywhere, ever. What happens here will set the pattern globally. This is the crossroads.
The big fear is that that escaped GE fish could threaten wild salmon runs. The FDA works on the assumption that there is no way GE Fish would escape contained pens along rivers on land. I'm reminded of earlier assumptions that farmed salmon wouldn't escape ocean net pens, and that GE crops wouldn't contaminate neighboring fields. If GE Fish do escape — and they inevitably would — these freakishly fast-growing salmon could interbreed with or out-compete wild salmon runs.
Rather than study the issues scientifically and make decisions democratically, the FDA is pushing a secretive, reckless approach. The Environmental Analysis is shamelessly shoddy. They brush aside deep scientific uncertainty, choosing instead to simply trust AquaBounty Inc.. They don't even pretend to confront social and economic impacts. Your average highway widening project undergoes more careful study.
Rather than operate above the table, the biotech company wants to manufacture eggs in Canada and grow their fish at a secret facility in Panama, then sell their product labeled only as "Atlantic Salmon" to unwary consumers in the United States. In other words, they don't want to follow our laws or employ our citizens. They just want to take our money.
Consumers loudly object to the lack of labeling. Surveys show most people don't want GE Fish on their plates, and even more think they should be labeled in the store. Over 2,500 grocery stores across the country, including major chains like Whole Earth and Trader Joe's, have pledged not to sell GE Fish.
Commercial fishermen and coastal residents express an array of concerns. Providing wholesome seafood from sustainable stocks is a responsibility fishermen take seriously. Alaska Trollers Association's Dale Kelley told me, "[t]he FDA has a long way to go before it can truthfully say that the risks of genetically engineered salmon have been fully evaluated and that this is a safe choice for consumers or the environment."
And what of the market effects? Copper River salmon command a premium price because they are high-quality, wild, and sustainable. That's good for us, consumers, and the planet. Unlabeled GE salmon in the market could undermine Copper River's good name and Alaska's hard-won wild fish economy.
Politicians spanning the political spectrum are standing up for their constituents in wild salmon territory. Our delegation of Begich, Murkowski and Young have lead the fight, introducing several pieces of legislation to stop, or at least improve, commercial GE salmon production.
Alaska's state legislature, in an incredible display of bipartisanship, unanimously passed a resolution opposing GE Fish. On April 18, Alaska state rep. Geran Tarr is visiting the AquaBounty facility in Canada, and meeting with local opponents as well. Turns out folks there also are proud of their local salmon. Working together, we can stop this thing.
We Alaskans are proud of our wild salmon, and should be proud to stand up for them on the international stage! We learned from past mistakes and have (more-or-less) successfully stewarded one of nature's greatest bounties. This is our heritage. Never apologize for defending it. If we don't, nobody else will.
Gabe Scott is Alaska field director for Cascadia Wildlands, and has a private maritime law practice in Cordova.

GE-Free Seafood Campaign Launched

As part of our effort to stop FDA approval of genetically engineered salmon, we are excited to announce we're part of a new coalition asking grocery stores to keep GE fish off their shelves and our plates by joining the Campaign for GE-Free Seafood

We are asking grocery stores, restaurants, chefs and other food companies to sign the pledge for GE-Free Seafood. The pledge simply states they will not knowingly purchase or sell GE salmon or other GE seafood, should it come to market. 

Since FDA won't require GE fish to be labeled, store policies against GE Fish will be the consumer's only way to avoid eating Frankenfish.

The coalition includes thirty consumer, food safety, fishing, environmental, sustainable agriculture, parent, public health and animal welfare organizations. Together we've sent the pledge to the nation's top grocery stores, and will be reaching out to even more.

Results are already pouring in. Some of the biggest stores in the U.S. have already signed on, including Whole Foods, Trader Joes, Marsh Supermarkets, Aldi, and PCC Natural Markets. This represents 2,000 stores accross the country. 

We're not done yet. In coming weeks we'll be reaching out to fish sellers in our local Cascadia bioregion, asking them to sign the pledge.

To make it easier for Cascadians to weigh in on this proposal, we've put together the Cascadia Petition Against Frankenfish, which surveys the good reasons we Cascadians can't abide someone tinkering with our salmon. By adding your name you can take your own personal stand, and bring even more pressure on F.D.A. and the seafood industry. 

Sign the Petition Here.


“You Keep Those Damn [Franken]Fish Out Of My Waters”

By Gabriel Scott

I've read some poorly crafted Environmental Assessments in my time, and seen more than a few ill-considered decisions, but this one might just take the cake.

Over the holidays the veterinarians at the Food and Drug Administration decided to approve an application to grow and sell genetically engineered salmon, a King/ Atlantic salmon cross with a sprinkle of eel pout, that grows twice as fast. This is the first time ever, in any country, that a genetically engineered animal would be approved for human consumption.

The decision is based on FDA’s preposterous conclusion that there is no difference between AquaBounty Technologies Inc.’s Frankenfish, and natural salmon, and no risk whatever of any environmental impacts. The decision is unleashing a firestorm of grassroots opposition. Objections span the ideological spectrum:

  • Health advocates say GE Fish pose higher risk of allergic reactions, contain larger quantities of cancer-causing chemicals, and offer fewer health benefits than natural fish; 
  • Commercial fishing organizations and economists fear the economic and social consequences of flooding the market with cheap, unlabeled GE fish; 
  • Consumer advocates object to the lack of labeling (they’d be sold as “Atlantic Salmon”); 
  • Environmentalists fear escaped GE Fish could interbreed with wild salmon, , decimating populations and unleashing a cascade of harmful ecological interactions; 
  • Moral objections are raised by those who see genetic engineering of animals as the ultimate human hubris;
  • Cultural objections are raised by indigenous peoples, for whom Atlantic and King salmon are sacred.
  • Policy-makers and academics point out the current regulatory system (it falls under “new animal drug” regulations so decisions are made by veterinarians) is totally ill-equipped to handle GE fish. 

All of these are good reasons to deny the application. In this post I’d like to raise what I think is the fundamental mistake FDA is making – they are making the decision blind.

It’s one thing to carefully weigh the pros and cons, and decide the risks are worth the reward. I’m not such a luddite as to think there is no room for debate on the merits of genetic engineering. But it’s another thing entirely when such a monumentally important decision is made on auto-pilot, without thinking it through and without stringent safeguards.

The Draft Environmental Assessment released over the holidays is all gimmick.

Here’s one example, a tricky legal maneuver to avoid even considering the economic and social effects. The gambit goes like this. Court cases suggest agencies don’t have to consider social, economic or cultural effects of a decision unless there are also physical environmental effects. Other cases suggest agencies don’t have to consider physical environmental effects outside the United States. Therefore, AquaBounty cleverly proposed to build their first batches of eggs in Canada, and to grow them out in Panama. Because the proposal takes place entirely overseas, and accepting the company’s claim that it is impossible even one fish would ever escape into U.S. waters, FDA claims there are no direct physical effects in the U.S., and, therefore, social, economic and cultural effects are ignored.

But as the economist Nicolaas Mink, PhD, explains in a recent article, these economic and social effects are a very big deal. 

Here’s another. FDA doesn’t consider what escaped frankenfish might do to wild salmon runs, based on AquaBounty’s assertion that nothing could go wrong and fish could never escape. Truth is, all kinds of things could go wrong. Storms and floods could breach containment and release fish (the eggs will be built mere yards from the Atlantic Ocean). Eggs could be lost or stolen. Eggs could be sold on foreign markets, entirely beyond U.S. jurisdiction, where they could be grown under who-knows-what conditions. Without any jurisdiction in Canada or Panama, the FDA would be unable to monitor or enforce the many promises AquaBounty has made.

Accidents aside, everyone knows this is only the beginning. FDA pretends it's a routine decision on a “new animal drug,” affecting only a couple of ponds in Canada and Panama. That’s just silly. This decision is all about the precedent. The venture capitalists behind AquaBounty didn’t spend tens of millions of dollars to grow a few fish in the mountains of Panama. The decision is being closely watched all over the world. If this goes forward, there will be little to stop GE fish from being raised in ocean net pens in the United States, Canada or elsewhere—or perhaps even set loose from hatcheries.

Making such a monumental decision on the premise that nothing could possibly go wrong, ever, is flat stupid. How many times have we been down this road? They said farmed fish in net pens can’t escape, but they do.  They said GE crops wouldn’t cross-pollinate, but they do. They said hatchery fish wouldn’t stray, but they do. Machines always work perfectly, until they don’t.

The really important question then is: what are the consequences of failure? The FDA studiously refuses to study it, but we can make educated guesses. AquaBounty’s GE salmon act like a person hopped up on steroids and high on crack. They are aggressive, live on junk food, are fearless of predators, and grow freakishly fast. A study in Proceedings of the National Academy of Sciences found that just 60 GE salmon in a population of 60,000 could result in extinction of the wild run in fewer than 40 generations.

If we come together and make our voices heard, we CAN stop this. We have allies. Lots of them.  Back when he was just a candidate with a funny name, Barak Obama said GE foods should be labeled. Oddly, the President abandoned even that moderate position, leaving conservative congress-critters to take up the fight. Senators Begich (D-AK) and Murkowski (R-AK) have promised to “fight tooth and nail.”

But the best expression I’ve heard yet comes from Don Young (R-AK), as conservative a guy as you’ll ever want to meet. This may be the first time we’ve found ourselves fighting alongside Mr. Young, but he expressed my feelings perfectly the other day when he growled: “You keep those damn fish out of my waters.”

Couldn’t have said it better.


To submit a comment to FDA, click here

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