A Senate hearing placed a spotlight on the regulatory tangle surrounding the approval process for genetically-engineered salmon. Potentially the country’s first GE animal for human consumption, the salmon have raised a host of worries among critics including the impact on the environment should they escape fish farms.

However, what came to the fore during the mid-December hearing was the complicated morass of government approval, oversight, and trade when dealing with the GE fish. Other GE animals are surely being developed and the current approval process outlined during the hearing seems ill-equipped to deal with the new technology.

Years ago, Massachusetts-based AquaBounty, submitted an application for its GE salmon to the FDA. In late 2010, preliminary analysis by the FDA – charged with regulating GE animals as “new animal drugs” -- said the fish were safe for consumption and were unlikely to harm the environment. That was hardly the last word as the approval process has since moved through a handful of other federal agencies.

Questions to the expert panel from the Subcommittee on Oceans, Atmosphere, Fisheries, and Coast Guard mostly came from the chairman, Alaska Sen. Mark Begich, and Maine Sen. Olympia Snowe. Both have large salmon industries in their states and Begich has introduced S.1717, which would ban interstate commerce of genetically engineered salmon.

For video and written statements from the hearing, see here.

“Did you ever consult with agriculture operators?” Snowe asked Ron Stotish, president of AquaBounty. “In Maine, we’ve had a number of organizations that came together for a mutual agreement for the aquaculture operators. Ultimately that has been very successful in containing salmon. We’ve had no escape in the last seven years…

“In respect to your proposal – land-based containment facilities -- what suggests … you can contain (GE salmon) 100 percent? That it is a fail-proof system?”

Stotish said the company had consulted “extensively” with experts in the aquaculture industry and the fisheries sector. “A fundamental issue … is the existence of rigorous management procedures which are essential in the operation of any facility (as well as) the inclusion of rigorous, redundant, multiple, biological and physical containment provisions.”

The environmental assessment of the GE fish is not an FDA-only review, said Stotish. “I am aware – although not privy to the details – that the environmental assessment prepared by the Center for Veterinary Medicine has also been reviewed by NOAA (National Oceanic and Atmospheric Administration), National Marines Fisheries Service, Fish and Wildlife Service, Department of the Interior, as well as the USDA and other federal agencies. This is not a simple, one-off review by the Center for Veterinary Medicine.”

If the fish are approved, AquaBounty plans to produce and sell a triploid, all-female egg produced in Canada “to FDA-approved and inspected facilities for grow-out. The first such facility is in Panama and has already been the subject of a detailed environmental assessment and FDA.”

Any other fish farms for the GE salmon “will be approved on a case-by-case basis by submission of an environmental assessment, review, a pre-approval process and pre-approval inspection by FDA. (These will) look at the unique attributes of the site, the management provisions in place and the unique containment provisions required.”

Pushback

The other members of the panel were less glowing in their assessment of the GE fish – which AquaBounty claims have a feed efficiency 10 to 20 percent greater than unmodified salmon -- and questioned the manner regulatory agencies have approached GE animal approval and shared information.

“A year ago, I was on a year-long detail with the U.S. Geological Survey, Department of the Interior, where I ran the fisheries program,” said John Epifanio, a fish conservation geneticist with the University of Illinois. “During the public hearing process last fall, these discussions were out there in the department. … Generally, the full set of information (regarding GE salmon) wasn’t always available to us, internally.”

Epifanio was careful not to “make FDA the punching bag. They have very fine scientists. … I’ve worked with them on traditional aquatic animal drug approval processes. It’s a very meticulous, very fine process and they do reach out.” Even so, “there is some opacity to the process that could be improved.”

With respect to the risk of GE salmon escaping containment, “the documents I’ve seen to date really don’t do a full, modern quantitative risk assessment of both the individual probabilities and the likely impacts if they do (escape),” said George Leonard, aquaculture program director for the Ocean Conservancy. “In particular there is a concept called ‘failure analysis’ … that determines where along a production system there is likely to be failure and then the consequences.”

In the future, Leonard advocated allowing NOAA or Fish and Wildlife to do the environmental assessment side of GE animal applications. “And they could have a very strong (voice) – perhaps, even, a veto – if they can’t be convinced those risks are addressed. (Currently), there is some consultation but the final decision is left to FDA.”

Stotish returned to the “regulatory paradigm” and said “a coordinated framework was agreed to and proposed by the Office of Science and Technology Policy and approved in 1986. In the subsequent 25 years, there was not a regulatory paradigm for the use of the policy in the regulation of transgenic food animals. As you know there has been significant development in agricultural products.”

With that in mind, “it took the majority of the time between 1986 and 2009 to arrive (at an answer) to whether (GE) organisms needed to regulated. As (has been) pointed out, this could be modern breeding technology. And, if so, who should regulate them?”

The result was “draft guidance 187” published in 2009 by the Center for Veterinary Medicine.

Author Paul Greenberg, who has written extensively on aquaculture and world fisheries, pointed out the government is already cash-strapped, without adding the burden of policing GE salmon. “Already, when you look at (aquaculture inspections) we can’t afford it. We only test two percent of (fish imports) coming into this country from abroad. Over 80 percent of our fish come from abroad. We want to add another regulatory burden on top of that? It doesn’t seem to make any sense to me.”

The lack of proper inspection of Asian fish imports is a long-time complaint of the U.S. catfish industry.

Sovereignty and inspections

Begich was curious about AquaBounty’s fish farm in Panama. “Who owns it? What’s the control mechanism?”

AquaBounty has leased the facility from the owner of the land, “who is also the largest trout farmer in Panama,” said Stotish. “The reason we went to that facility is there was great interest in Panama as an economic development tool to grow (GE salmon)…

“We are in control of that facility. … We’re periodically inspected by authorities in Panama, Canada and the United States.”

As Panama is a foreign nation, Begich asked if the FDA has legal authority to inspect the AquaBounty facility there.

Stotish: “You’re getting into the weeds of a very thorny geopolitical issue.”

The question is important, said Begich, following hearings on airline inspections done in foreign countries. “We’ve had to pass legislation because -- even though they all tell us they’re all inspected and great – they’ve moved all their maintenance facilities to foreign countries with less rigorous (inspections) because FAA (Federal Aviation Administration) guys can’t get over there and inspect on the same level as they can here.”

As background, Stotish said the Carter administration had come up with the concept of Global Commons where “any federal agency has the responsibility for the environmental consequences of any action anywhere in the world. That bumps up against the issue of sovereignty of foreign nations and their right to regulate products within their own geography.”

As for the Panamanian GE salmon farm “there has been a remarkable degree of international cooperation between regulatory agencies that have worked together, shared information and shared inspections. In fact, the FDA is training regulators and inspectors from Panama as they implement new regulations in this area.

“So, we’re not just regulated by the Center for Veterinary medicine, we’re regulated by (various Canadian agencies) and by Panamanian aquaculture authorities. There is more than enough inspection and oversight of our facility and we have frequent inspections.”

Snowe: “Why is it important to have GE salmon as opposed to pursuing traditional salmon aquaculture?

Land-based facilities are the “way of the future,” replied Stotish. “But one of the barriers to successful land-based cultivation of Atlantic salmon is the slow growth rate in the early part of the life cycle, the first one to three years of life. That’s specifically the part of the life cycle that’s accelerated in our rapid growth phenotype.”

The GE fish would also create opportunity for economic development in “Midwestern states, the Dakotas, Wisconsin, Ohio, and Minnesota,” said Stotish. “These land-based facilities could produce salmon closer to consumption centers without long transportation lines.

“We haven’t talked about transportation costs – both direct and environmental. It’s very expensive to fly salmon from south Chile or Oslo to New York in 747s.

“The ability to grow (GE salmon) would recreate an industry largely lost in the United States. We produce less than 17,000 tons of Atlantic salmon in the United States each year. The opportunity to create that industry and reduce imports and produce food locally is … what we think this product will bring to the marketplace.”

Stotish also said representatives of the Chinese government have claimed more than 70 applications are currently pending for transgenic animals and fish. Argentina and Brazil along with other countries have also “embraced the technology and are employing it.”

Fragmented process

Following Stotish’s explanation regarding the fragmented regulatory process, Begich expressed some sympathy. Pointing to Alaska, he said “the regulatory process is enormous and the amount of agencies that have to sign off is pretty significant.”

However, Begich said there is a great difference between the FDA regulating a drug and a GE animal. “When you’re (looking) at a drug, it isn’t a whole environment you’re about to touch. … The FDA is very good at approving drugs. Maybe they take a long time, but they’re good at it. Once approved, you’re talking about individual consumption, not a whole environment.”

As an example of unintended environmental consequences, Begich lamented the impact released voracious pike have had on an Alaskan lake near where he lives.

Leonard argued that the question isn’t whether there is a regulatory structure in place to deal with the GE salmon. “There certainly is. The question is whether it addresses what we, as a society, want it to address. I think the answer is ‘no.’”

Leonard said the new animal drug provisions within the coordinated framework of the FDA “were developed before the concept GE animals for human consumption was on the table. In that sense, they’re outdated with respect to that particular issue.”

Much of the resistance to GE salmon “is because of the secretive nature” of the regulatory, deliberative process. Stakeholders and the public, he said “have not been part of the process from the beginning” leading to a lack of trust and understanding.

Greenberg mined the same vein, saying when he tells those outside government that the FDA is the ultimate approving agency for GE animals, “they can’t believe. They just can’t believe it. It just reeks of not going a direct and honest pathway. I understand there must be bureaucratic reasons why it’s happening. But from outside the government perspective, it doesn’t feel right.”

Begich agreed that the government “isn’t very good about keeping pace with technologies as they move forward. We’re always trying to catch up with (information technology) and telecom issues. … We kind of scratch the back end of it as it moves to the next phase. But with food products, it’s a step we have to be very careful of.”

On the argument that GE salmon will allow America to compete with China, Greenberg was dismissive. “Do we really want to hold up China a beacon for environmental regulation to aspire to? Moreover, if this fish does get developed” he is optimistic “it will end up in China one way or another. If they can steal our stealth fighter, they can get a hold of (GE salmon). I’d rather us be a country that says ‘no’ to that kind of risk. Let someone else take the risk and we’ll have better fish because of it.

“One of the great markets for Alaskan salmon has traditionally been Asia because they don’t have what we have. If we really want more salmon in America, let’s not sell 70 percent of our Alaskan salmon abroad.”

Leonard, who acknowledged AquaBounty’s “forthrightness in the information provided today,” was more concerned with the broader issue of the government’s GE animal approval and applications to come. “The question is less about this individual application … and more about whether we have a system in place that will allow us to deal with the next application to come down.”

And what about liability? If harm from GE animals occurs “who is responsible?” asked Leonard. “It’s a legal question not a scientific one. But it’s an issue that hasn’t been addressed at all and is worthy of consideration.”