GENET archive

[Index][Thread]

RISK ASSESSMENT & APPROVAL: Activists fight FDA approval of AquaBounty’s genetically engineered salmon



                                  PART 1


------------------------------- GENET-news -------------------------------

TITLE:   ACTIVISTS FIGHT FDA APPROVAL OF AQUABOUNTY?S GENETICALLY ENGINEERED SALMON

SOURCE:  Miami Herald, USA

AUTHOR:  McClatchy Newspapers, USA, by Erika Bolstad

URL:     http://www.miamiherald.com/2013/03/05/3268294/activists-fight-fda-approval-of.html

DATE:    05.03.2013

SUMMARY: "More than 33,000 fishermen, environmentalists, food safety advocates and others have written to the FDA with concerns about the agency?s preliminary findings. Among the worries is that the genetically engineered fish might escape and mix with wild salmon. The company says that?s unlikely, not only because the fish are sterile but also because of its production process. But there?s a reason that Alaska bans salmon fish farms in the state, the Sitka Conservation Society, an environmental group in southeast Alaska, said in its letter to the FDA. They fear that the company will expand to the U.S., where the fish would be closer to native salmon populations. ?These farms pollute water with concentrated fish waste and feed, spread sea lice and ultimately lead to escapement and interbreeding,? the organization said."

----- archive: http://www.genet-info.org/information-services.html -----


ACTIVISTS FIGHT FDA APPROVAL OF AQUABOUNTY?S GENETICALLY ENGINEERED SALMON

WASHINGTON -- Every summer since 1979, Kim Hubert has fished for sockeye salmon in Alaska?s Bristol Bay. It?s a family business in tiny Togiak that has, from time to time, also employed his wife and three children.

Hubert and his 21-year-old daughter work the nets now. They?re small permit holders who may catch and sell thousands of salmon in their nets each year, depending on the success of the run.

?We?ve got a fish camp out there, we enjoy the people and the bay and the work,? said Hubert, 58, a retired schoolteacher who lives in Eagle River. ?Some years we lose a few bucks, and some years we make a few.?

They and other fishermen have been casting a wary eye on Washington, where the Food and Drug Administration is considering whether AquaBounty, a Massachusetts-based company with a lab on Prince Edward Island in Canada and growing facilities in Panama, may sell genetically engineered salmon to consumers in the United States.

More than 33,000 fishermen, environmentalists, food safety advocates and others have written to the FDA with concerns about the agency?s preliminary findings. Among the worries is that the genetically engineered fish might escape and mix with wild salmon. The company says that?s unlikely, not only because the fish are sterile but also because of its production process.

But there?s a reason that Alaska bans salmon fish farms in the state, the Sitka Conservation Society, an environmental group in southeast Alaska, said in its letter to the FDA. They fear that the company will expand to the U.S., where the fish would be closer to native salmon populations.

?These farms pollute water with concentrated fish waste and feed, spread sea lice and ultimately lead to escapement and interbreeding,? the organization said. ?If genetically modified salmon are permitted, it will be only a matter of time before they are muddling the pure wild population in Alaska.?

Mostly, though, fishermen in Alaska fear that the new, faster-growing farmed fish would threaten their livelihood eventually by flooding the market with cheap fish. They?re also pressing for the AquaBounty salmon to be labeled as genetically engineered because they think that their wild-caught, more expensive product is superior. They want no confusion in the marketplace.

?In some ways I felt threatened,? Hubert said. ?The threat may not be immediate, but I think down the line there could be some repercussions. We?ve had a lot of issues with labeling, and the ability (of consumers) to choose and know where the fish come from: what kind of stocks, whether they?re farmed or wild fish.?

The AquaBounty fish are Atlantic salmon that have been genetically altered with growth genes from a Chinook salmon and a sea eel. That makes them grow faster than other farmed Atlantic salmon, although they don?t get any bigger than regular salmon.

The FDA issued a preliminary finding in late December that the fish, known as the AquAdvantage Salmon, is as safe as eating conventional Atlantic salmon and that there?s a reasonable certainty of no harm in consuming it. The agency also issued a draft environmental assessment that there?s little chance of environmental harm from farming the fish.

However, after pressure from Congress ? especially from Alaska lawmakers ? the FDA in February extended the public comment period on its findings by 60 days. People have until April 26 to weigh in, and after that the agency will decide whether to issue a final report or pursue a more comprehensive environmental impact statement.

Read more here: http://www.miamiherald.com/2013/03/05/3268294/activists-fight-fda-approval-of.html#storylink=cpy

AquaBounty executives aren?t currently granting interviews. The company?s last public statement came in mid-February, when the FDA announced that it would extend the comment period. AquaBounty Chief Executive Officer Ron Stotish said at the time that they weren?t pleased with the delay.

Some food safety advocates are pushing for the FDA to do a full environmental review. They?re also petitioning the agency to consider the AquaBounty fish as a food additive rather than as an animal drug. The FDA uses its animal drug process to consider the safety of all potential genetically modified animals sold as food.

That change would make the approval process more transparent, as well as focus on the safety of the salmon as food, said Patty Lovera, the assistant director of Food & Water Watch. It joined Consumers Union, which is the advocacy division of Consumer Reports, and the nonprofit Center for Food Safety to petition the FDA.

?We just think it?s really deficient on the food front,? Lovera said. ?What do we really know about allergies? What do we know about nutrition profile? That stuff?s really sketchy in that application that they put in. And we?d like to see a lot more of that, considering you?re going to eat the whole thing.?

People and animals already consume plenty of genetically modified grains, which aren?t required to be labeled in the U.S. A ballot measure requiring such labeling failed recently in California.

But the fish are the first genetically engineered animals being considered for human consumption in the U.S., and the approval process is being closely watched in the biotech field.

There?s a huge market for heart-healthy fish: Salmon is the second most popular seafood consumed in the U.S., behind tuna. And an estimated 91 percent of the seafood consumed in this country is imported; about half of that is from aquaculture.

Even if the AquaBounty fish is approved, however, supermarkets won?t be flooded with genetically engineered fish anytime soon, said Gregory Jaffe, the director of biotechnology at the Washington-based Center for Science in the Public Interest, an advocacy organization. Jaffe was on the FDA advisory panel that reviewed the safety of the salmon in 2010 and found no cause for alarm.

AquaBounty would have to reapply to the FDA to expand operations.

?They talked about hundreds of tons of salmon a year. We import hundreds of thousands of tons of salmon a year,? Jaffe said. ?So maybe it?ll be slightly easier to eat one of these salmon steaks than to win the lottery. But if someone wanted to find one of these salmon steaks out there to eat, it?s going to take a little effort.?

That hasn?t stopped lawmakers from Western states from fighting the FDA findings ? or at a minimum, seeking a requirement that genetically engineered salmon be labeled. Consumer groups are making the same push.

?Any fish that is labeled as wild-caught, or Alaskan, might see some of its market actually go up,? said Michael Hansen, a senior scientist for Consumers Union. ?Since this will not be labeled, people would not know whether the regular salmon they?re buying is engineered or not.?

In his mid-February statement, AquaBounty?s Stotish noted that no new facts had been introduced since the FDA?s findings late last year and that the company doesn?t think the additional comment period ?materially affects our chances for approval.?

?There has been neither new information nor a clear legal or regulatory issue raised by the FDA since that time,? he said in the statement.

AquaBounty says in its press materials that it wants its fish to be labeled ?Atlantic salmon.? The company says the nutritional and biological composition of its AquAdvantage Salmon is identical to Atlantic salmon, and therefore doesn?t require additional labeling based on its method of production.

The company notes that it supports voluntary branding by the farmers who grow its salmon, to identify what it calls ?the environmentally friendly benefits of this product.?

An FDA spokeswoman, Theresa Eisenman, said a decision hadn?t yet been made regarding labeling AquAdvantage Salmon.

The FDA since 1992 has considered bioengineered foods to be no different from other foods ?in any meaningful or uniform way.? The agency supports voluntary labeling that provides consumers with such information, however.



                                  PART 2

------------------------------- GENET-news -------------------------------

TITLE:   ISLANDERS SAY NO TO GM SALMON

SOURCE:  Canadian Biotechnology Action Network, Canada (CBAN)

AUTHOR:  Press Release

URL:     http://www.cban.ca/Press/Press-Releases/Islanders-Say-No-to-GM-Salmon

DATE:    28.02.2013

SUMMARY: "Islanders Say No to GM Salmon is calling on Premier Ghiz to ban the production of genetically modified Atlantic salmon eggs in PEI. As the United States edges closer to approving human consumption of GM salmon in the next months, increased attention is now focused on Canada, and in particular PEI, as the only source of GM salmon eggs on the planet. The experimental lab-created Atlantic salmon eggs have been produced by AquaBounty, an American company, at a remote facility in Bay Fortune, PEI for more than a decade while it tries to convince the U.S. government to allow the mutant fish into grocery stores."

----- archive: http://www.genet-info.org/information-services.html -----


ISLANDERS SAY NO TO GM SALMON

GM Opponents ask Premier to Ban GM Salmon Egg Production in PEI

Charlottetown ? Islanders Say No to GM Salmon is calling on Premier Ghiz to ban the production of genetically modified (also known as genetically engineered or GE) Atlantic salmon eggs in PEI. As the United States edges closer to approving human consumption of GM salmon in the next months, increased attention is now focused on Canada, and in particular PEI, as the only source of GM salmon eggs on the planet.

The experimental lab-created Atlantic salmon eggs have been produced by AquaBounty, an American company, at a remote facility in Bay Fortune, PEI for more than a decade while it tries to convince the U.S. government to allow the mutant fish into grocery stores.

AquaBounty proposes to produce the GM salmon eggs in PEI, ship them to Panama for growing out and processing, then send the GM fish into the U.S. market. Using PEI and Panama to produce the fish allows AquaBounty to avoid an even more contentious environmental assessment process in the US, said Islanders Say No to GM Salmon spokesperson Sharon Labchuk.

Already the US government has received more than 30,000 comments from citizens and groups as part of the public process to assess the GM fish. Almost one million people have signed an online petition from Avaaz, a global civic action organization, against GM salmon.

Even the aquaculture industry doesn?t support GM fish and says there is no market for them.
?Scientists say the escape of just 60 GM salmon, and fish escape all the time from aquaculture facilities, could mean the end of the wild Atlantic salmon, a species already struggling to survive,? said Labchuk. ?The mutant fish are engineered to produce unnatural amounts of growth hormones causing them to grow quickly. The worry is these fast-growing frankenfish will outcompete wild salmon for food and breed with them, effectively eliminating the species.?

AquaBounty claims the GM salmon will be grown in land-based pens in Panama but the company will have no control over regulations in other countries once the eggs are marketed around the globe. The company claims the fish are sterile but it?s own data submitted to the U.S. government shows up to 5% of the fish will be capable of breeding.

?A coalition of PEI organizations has lobbied both Liberal and Tory governments over the years for a GM-free province,? said Leo Broderick, Islanders Say No to GM Salmon representative. ?Now because of the urgency of the situation we?ve come together to focus on a GM salmon ban. Canada has not yet approved commercial production of the GM salmon eggs but we fear if the U.S. gives approval to human consumption of GM salmon the Harper government will quickly follow suit and approve not only the sale of the frankenfish in grocery stores but the production of mutant salmon eggs as well,? said Broderick.

This month the Alaska House of Representatives came out in opposition to GM Atlantic salmon, saying it has concerns about threats to human health and wild salmon stocks, and potential negative impacts on the wild Alaska salmon fishery. Islanders Say No to GM Salmon asked Premier Ghiz to similarly tell the Harper government that PEI opposes GM salmon. The group said that even if Prime Minister Harper does approve GM salmon egg production, Premier Ghiz has the authority to ban production in PEI. 
?There is no evidence the frankenfish are safe to eat,? said Mary Boyd, group representative. ?Genetically engineered salmon have higher levels of IGF-1, a growth hormone that according to experts may increase the risk of several types of cancer.?

?In past years, international media reported on PEI?s role in AquaBounty?s quest to market the world?s first GM animal for human consumption,? said Labchuk. ?Attention is now intensifying and PEI is poised to be a critical player. Do we want PEI known around the world as home of the frankenfish, the province that could have stopped GM salmon from wiping out Atlantic salmon but didn?t? There?s nothing to gain and everything to lose by letting this American company, concerned only with lining its own pockets, set up shop in PEI. It?s up to Islanders to say no to GM salmon.?

Islanders Say No to GM Salmon is a group organized to push for a ban on GM Atlantic salmon eggs in PEI but the founders of the group are all long-time opponents of GMOs in PEI. Leo Broderick, Sharon Labchuk and Mary Boyd formerly worked in collaboration for years under the banners of organizations we represent, respectively, the Council of Canadians (PEI Chapter), Earth Action, and the PEI Health Coalition.

Opposition to genetically engineered organisms began in PEI with the introduction of Monsanto?s NewLeaf potato in the mid-90?s. Our campaign, assisted by many national and international organizations, forced Monsanto to withdraw the GM potato from the global market. No GM potato has been approved in Canada since.

We began to campaign against AquaBounty and its GM Atlantic salmon in 2000, including participating in an action with Greenpeace at the AquaBounty site that was broadcast around the world. We campaigned for PEI to be GMO-free zone beginning in 2001 culminating in legislative public hearings in 2005. More presentations were made at these hearings than at any other legislative hearings in the history of the province. With the U.S. poised to make a decision in the coming months on approving GM salmon for human consumption, our efforts in PEI will ramped up.

We are members of the Canadian Biotechnology Network (CBAN), a coalition of anti-GMO organizations, and work closely through CBAN with our American colleagues on issues like the GM salmon. With CBAN we?ve participated in public panel presentations in PEI and other provinces and attended U.S. government hearings on the GM salmon.



                                  PART 3

------------------------------- GENET-news -------------------------------

TITLE:   WILL GE SALMON OPPOSITION BE THE ?KISS OF DEATH? FOR AQUABOUNTY?

SOURCE:  Undercurrent News, USA

AUTHOR:  Jeanine Stewart

URL:     http://www.undercurrentnews.com/2013/03/05/will-ge-salmon-opposition-be-the-kiss-of-death-for-aquabounty/

DATE:    05.03.2013

SUMMARY: "The original deadline for public comment on Aquabounty?s genetically engineered ?Aquadvantage Salmon? came and went last Tuesday, without conclusion. Thanks to an extension request by Alaska Senator Lisa Murkowski that the Food and Drug Administration granted, the public has until April 26 to add more arguments against the product, and with opposition voices speaking up loud and clear, industry sources are mixed on whether they think the product will see success in the US market. To understand what retailers told Undercurrent News this week, it?s first important to first understand the level of political awareness surrounding the prospect of GE salmon in the US market."

----- archive: http://www.genet-info.org/information-services.html -----


WILL GE SALMON OPPOSITION BE THE ?KISS OF DEATH? FOR AQUABOUNTY?

The original deadline for public comment on Aquabounty?s genetically engineered ?Aquadvantage Salmon? came and went last Tuesday, without conclusion.

Thanks to an extension request by Alaska Senator Lisa Murkowski that the Food and Drug Administration (FDA) granted, the public has until April 26 to add more arguments against the product, and with opposition voices speaking up loud and clear, industry sources are mixed on whether they think the product will see success in the US market.

To understand what retailers told Undercurrent News this week, it?s first important to first understand the level of political awareness surrounding the prospect of GE salmon in the US market.

Avaaz.org, self-described as an international citizens group, has collected nearly 1 million - 991,340, to be precise - signatures for its ?Stop the Frankenfish attack? petition against Aquabounty?s application as of last Thursday, and that is just the most recent news to break.

Alaska senators Mark Begich and Murkowski had already introduced two pieces of legislation against GE salmon to the US Senate. The first was the Prevention of Escapement of Genetically Altered Salmon in the United States (Pegasus) Act, which would ?make it illegal to produce, sell or ship genetically engineered salmon in the United States unless the National Oceanic and Atmospheric Administration (NOAA) finds that it wouldn?t negatively affect the natural fish population,? according to TheHill.com.

The second, S.248, would require any genetically engineered salmon products to be labeled as such in the US.

Similarly, California voters were faced with Proposition 37 in November, which would have required all genetically engineered food to be labeled as such. It failed by a narrow margin.

Then there is Washington state?s Initiative 522, ?The People?s Right To Know Genetically Engineered Food Act?, which would require genetically engineered salmon to be labeled along with a host of other food products, including nearly anything made with corn or soy. The initiative will either be dealt with during the state?s current legislative session, which ends April 26, or it will go to the people for a vote in November.

But that law would only affect Washington state, so it is more significant as an influence on public opinion than as a matter of law. As for the federal laws, they are not likely to go into effect, said The Center for Science and the Public Interest?s Greg Jaffe.

?We have confidence in the process and if there?s a fair and science-based discussion, our national policy will end up in the right place?

?It?s hard to believe they?d pass legislation mandating labeling in this congress that we have,? Jaffe told Undercurrent, referring to a high level of political gridlock that has plagued the US congress in recent months.

The support website for I-522 is a good example of how high the level of awareness surrounding GE salmon is. It lists GE salmon at the top of its list of major products of concern, while GE corn and soy are already in production in much higher volumes than Aquabounty could produce once it starts.

Yet this awareness appears to be misplaced. Jaffe notes that if GE labels do become mandatory, they will have a far greater impact on the corn and soy industries than the salmon industry.

AquaBounty CEO Ron Stotish is less than happy with the political campaigns his company seems to have inspired.

?We support the current policy; we believe in truthful labeling. What we don?t support is demagoguery, misrepresentation and intellectual dishonesty,? he told Undercurrent.

The timing of these political efforts is not too good for AquaBounty. It not only comes right in the middle of the extended public comment period for Aquabounty?s application, it also comes as the company deals with financial challenges.

At one point last year, it was unclear if AquaBounty would have the funds to continue until the biotechnology company Intrexon bought a 48% stake in the company last October and offered to buy the other 52 percent in December.

The political campaigns could also have the power to impact the FDA?s decision on whether it will do more studies or accept its 2010 preliminary finding that the product would have no adverse impact on the environment.

Meanwhile, Aquabounty?s application process stretches on without an unclear end date. The FDA still has many hoops to jump through before making its decision.

?Once the comment period has closed, we will review all of these comments before determining if we need to make any revisions to the Environmental Assessment (EA) and whether the Finding of No Significant Impact (FONSI) should be finalized or whether we need to issue an Environmental Impact Statement,? Siobhan DeLancey, veterinary medicine team lead for the US Food and Drug Administration, told Undercurrent.

Yet amidst the political noise, Stotish remains optimistic about his product?s prospects for approval.

?We have confidence in the process and if there?s a fair and science-based discussion, our national policy will end up in the right place,? Stotish said.

The next hurdle ? consumer acceptance

If the product does get approved, it could run up against a host of other problems, sources in the retail industry told Undercurrent.

?The jury is still out on AquaBounty,? Phil Gibson, senior vice president for the food and consumer goods consulting firm Encore Associates, told Undercurrent.

A reputation for being genetically engineered ? whether it comes through mandatory labeled or the robust political campaigns that have already developed ? could be the ?kiss of death?, said Gibson, who was Safeway?s group director for seafood until December, when he left for Encore.

When farmed salmon was labeled to have color added ten years ago, people thought that meant producers were adding red dye to the fish to make them pink, he said. This ?absolutely? had a negative impact on sales.

Carl Salamone, VP of Seafood for US retailer Wegman?s, agrees a GE label would be harmful in the beginning but differs on the degree.

?The GM issue will only become relevant to [foodservice] when the price is competitive with what we buy now?

?Initially, labeling as such will slow down sales and bring a barrage of questions,? Salamone told Undercurrent, but added, ?This will wear off based on the retail as compared to other salmon and the taste if and when the customers have an opportunity to sample.?

A consultant in the industry gave a similar opinion.

?Long term, I think GE fish and other species will make it successfully into the marketplace, even if there are bans or objections in the short to mid term,? the source said. ?It will take debate, scientific advancement, and testing, but over time, if the fish is safe and more efficient, it will be produced.?

Executives at two other large US consumer-facing foodservice groups said the issue of whether they would source GM salmon or not had not yet come up for their companies.

Should GE products be labeled?

Sources are also mixed on whether they believe GE foods should be labeled as such.

?One of the big concerns about any labeling is that if you put those words on the package, and there?s no safety concern, are you misleading the consumer by labeling one (product) one way and one the other way,? said Jaffe.

?Then if they?re not knowledgeable about it, they might choose to avoid that when maybe there?s no objective reason to avoid it. That?s why one has to be very careful about any labeling.?

According to the FDA, current law requires food labels to have statement of identity, a list of ingredients, net weight or volume (for liquid products), name and address of a responsible firm and a country of origin statement.

But at the same time, Jaffe said consumers have a right to know whether a product is GE if they want to know.

?If people are saying ?I don?t know if this is GE or not,? those people should be able to find out,? Jaffe said. ?Companies should not hide that from them.?

But because so many consumers want to know whether the product is genetically modified, other sources, including Salamone, thought the product should be labeled.

A procurement manager with a US seafood foodservice chain agreed. ?I have no problem with the label showing that it is a GM food,? he told Undercurrent. ?I think there will always be people that do not want it, so a consumer should be able to clearly understand what they are buying.?

However, only time will tell whether retailers will accept it or not, and that has more to do with price than it does with the political argument of the month.

?The GM issue will only become relevant to us when the price is competitive with what we buy now,? he said.