Panama officials have slapped a near-maximum fine of USD 9,500 on AquaBounty Technologies, a US biotech company, for repeated regulatory violations in its experimental facility growing genetically modified (GM) salmon in tanks. The company had failed to secure necessary permits, particularly around its use of water and pollution of the local environment, potentially important issues given the possibility of contamination of natural systems. The authorities noted their view that the company had "repeatedly violated" these regulations, and stated that these problems persisted into 2013.
AquaBounty has a pending application with the US government to sell its GM salmon fillets in the country. If approved, this salmon would be the first GM meat sold for human consumption in the world and would likely pave the way for other GM animals, 35 of which are said to be in the pipeline (Item 1).
Several NGOs have called on the US Food and Drug Administration (FDA) to terminate its ongoing safety review of AquaBounty’s GM salmon and reject its application (Item 2). Several concerns have been raised, including the risk of the GM fish escaping into the wild, potentially out-competing wild populations or introducing new diseases as well as contaminating fish exports.
There has also been strong public opposition to the introduction of the GM salmon with some 1.8 million objections received in response to the FDA’s call for comments in 2012 and 60 major U.S. retailers to date expressing outright refusal to sell any GM seafood, irrespective of FDA approval. Members of the US Congress have likewise expressed concern, and legislation has been proposed that would require the labelling of GM fish.
Washington, 29 Oct (IPS) — Officials in Panama have fined the local facility of a US biotechnology company for a series of permitting and regulatory failures around a pioneering attempt to create genetically modified salmon.
The experiments are being carried out by researchers for AquaBounty Technologies, which currently has an application with the US government to sell genetically modified (GM) salmon filets in this country.
If regulators approve that application, AquaBounty’s salmon would be the first genetically modified meat sold for human consumption anywhere in the world.
Further, companies in the United States and around the globe are said to be actively watching US regulators’ response to AquaBounty’s application as a critical indication of whether to proceed with other GM meat projects.
"AquaBounty is really out front on this – the current case will set an important precedent," Dana Perls, a food and technology campaigner at Friends of the Earth, a watchdog group, told IPS.
"From what we know, there are about 35 other genetically modified species in the development pipelines in other companies. So depending on what happens in this case, we’ll likely either see a flow of other permits or this will demonstrate that there isn’t room on the market for GM meat or seafood."
AquaBounty’s application with the US government would involve getting filets of the new GM salmon from the company’s breeding facility in Panama and into the US market.
Advocates are now pointing to the Panamanian authorities’ findings of regulations violations as an indication that the US regulatory process is proceeding too quickly in considering the salmon application.
"The impacts GM foods will have on health and the environment have not been sufficiently assessed to approve human consumption of this salmon," Luisa Arauz Arredondo, an attorney with the Panama Centre for Environmental Advocacy, which filed the administrative complaint against AquaBounty, told IPS.
She notes that while AquaBounty’s facilities in Panama have permission to run experiments on the salmon, the country has not approved anything further. "The salmon would not be sold to Panamanian consumers," she says, "since the human consumption of GM salmon has not been approved by Panama or the US."
The Panamanian regulatory decision, which was made public on Tuesday, actually stems from a 2012 investigation of AquaBounty’s facilities and was decided in July of this year.
It found that the company had failed to secure necessary permits, particularly around its use of water and pollution of the local environment – potentially important, advocates say, given the possibility of contamination of natural systems.
The authorities noted their view that the company had "repeatedly violated" these regulations, and stated that these problems persisted into 2013. They deemed the transgressions significant enough to levy almost the maximum fine allowable against the company.
AquaBounty Technologies suggests that the concerns outlined by Panama’s government were largely administrative in nature and notes that any problems have all been dealt with already.
"It is important to emphasize that none of the issues in the Resolution questioned the containment, health of the fish, or the environmental safety of the facility," the company said in a statement sent to IPS.
"When AquaBounty was informed of issues at our Panama facility, we immediately contacted ANAM, the Panamanian agency for the environment. We initiated a program to remedy the deficiencies and the issues were formally resolved in August of 2014."
Whether the actions on the part of Panama’s government will impact on the ongoing consideration of AquaBounty’s application by the US Food and Drug Administration (FDA) remains to be seen.
A spokesperson for the FDA likewise pointed out that AquaBounty’s violations were based on a 2012 inspection, but also said the agency would "consider all relevant information as part of the decision-making process."
The spokesperson noted that the agency is in the process of completing its review of the company’s application, but declined to provide a timeline on what that decision will be made.
For environmentalists, public interest groups and anti-GMO advocates, the Panama findings underscore a potential weakness in the FDA’s regulatory process.
"This decision is also even further proof that FDA is dangerously out of touch with the facts on the ground, advancing AquaBounty’s application based on its promises, not reality," George Kimbrell, a senior attorney with the Center for Food Safety, a Washington-based advocacy group, said Tuesday.
Friends of the Earth’s Perls says that the FDA’s current regulatory review of the GM salmon application is based solely on the single AquaBounty facility in Panama.
"The FDA is going forward with its review based on the premise that this facility will be in compliance with regulations, yet now we’re seeing it’s not," she says. "It is increasingly clear that there is inadequate regulation: the FDA is trying to shoehorn this new genetically engineered animal into a completely ill-fitting regulatory process."
Much of the concern here revolves around the potential for genetically modified hybrids to escape into the wild, potentially out-competing wild populations or introducing new diseases.
Yet the issue also runs up against the scepticism that continues to colour consumer response to genetically modified foods – and the sense that regulators are moving too quickly to approve these products.
When the FDA in 2012 asked the public to weigh in on the AquaBounty salmon application, it received some 1.8 million comments expressing overwhelming opposition. Members of the US Congress have likewise expressed their concern, and legislation has been proposed that would require the labelling of genetically modified fish.
As yet, there is no legal requirement in the United States to label any genetically modified food or ingredient, though the state of Vermont could soon impose such a mandate.
According to a media poll conducted last year, some 93 percent of people in the US support the labelling of genetically modified foods, and three-quarters said they would not eat GM fish.
Yet perhaps the most significant indication of public sentiment on this issue has come from the retailers that have preemptively stated that they would not sell genetically modified fish and seafood – regardless of whether the FDA approves its sale.
According to data compiled by Friends of the Earth, some 60 major US food retailers have already pledged to do so, including several of the country’s largest grocery chains.
"Should GE salmon come to market, we are not considering nor do we have any plans to carry GE salmon," Safeway, the second-largest grocer in the United States, said in a policy statement released in February.
"Safeway’s [policy] calls for all of our fresh and frozen seafood to be responsibly sourced and traceable or be in a time-bound improvement process by the end of 2015."
October 28, 2014—Brussels and Washington, DC. Officials in Panama fined U.S. biotech company AquaBounty Technologies a near-maximum US$9,500 after ruling that the company has been operating in violation of environmental regulations during its experiments with genetically modified (GM) salmon. Food & Water Europe, Food & Water Watch, the Center for Food Safety and Friends of the Earth U.S. today called on the U.S. Food and Drug Administration (FDA) to terminate its ongoing safety review of GM salmon and to reject AquaBounty’s pending application to sell the company’s GM fish in the United States.
“The FDA has always assured the public that it is checking, monitoring and regulating AquaBounty’s production platform to ensure that the company can mitigate the well-documented environmental impacts of escaped GM salmon,” said Wenonah Hauter, executive director of Food & Water Europe. “We now know that AquaBounty is unwilling or unable to follow basic rules and regulations, and that the FDA is unable or unwilling to enforce them. It’s time to put an end to this dangerous experiment.”
Last week’s decision from the Panamanian National Environmental Authority came in response to a complaint filed last year by the Panamanian environmental organization Centro de Incidencia Ambiental (CIAM). Regulators found AquaBounty out of compliance with a raft of environmental safety rules and regulations, including failing to secure prior to beginning operations the legally required permits related to water use and water discharge. Regulators concluded, “We are of the opinion that it [AquaBounty] has repeatedly violated the aforementioned environmental regulations.” The US$9,500 penalty is very near the US$10,000 maximum penalty provided for in Panamanian law.
AquaBounty’s facility in Panama has long experienced serious security issues, including a storm-related accident that led to “lost” salmon in Panama. A visiting journalist described the company’s facility as a “run-down shed.”
To date, the FDA has made no regulatory decision on AquaBounty’s application to sell GM salmon, which, if approved, would be the first biotech animal to enter the food supply anywhere in the world. The FDA’s current regulatory review considers only one production scenario in which AquaBounty produces GM salmon at a remote facility in Panama, then sends fillets to U.S. retailers. Critics have long worried that AquaBounty chose its out-of-the-way production facility as a way to evade regulatory scrutiny.
“In the European Union, we are well aware that GM foods are not labeled in the U.S. One of the big reasons we are fighting the U.S. approval of GM salmon for food is the grave doubts surrounding the ability of either AquaBounty or the U.S. food system to keep these GM fish out of exports headed our way,” said Eve Mitchell, EU food policy advisor for Food & Water Europe. “If AquaBounty doesn’t even have legal permission to do what it is doing, it only adds to worries that the entire regulatory process is too full of holes to be trusted, especially on something as important as a safety assessment. We do not want GM salmon in the EU, and we don’t think anyone else does either, so it’s time for the FDA to reject the application and put this thing behind us.”
Contacts:
Eve Mitchell, Food & Water Europe (UK time), +44(0)1381 610 740, emitchell@fweurope.org
Rich Bindell, Food & Water Watch (Washington time), 202-683-2457, rbindell@fwwatch.org