In November 2015, the fast-growing AquAdvantage® Salmon became the first genetically engineered animal approved for human consumption. The announcement marked the end of a pioneering regulatory process that took 20 years and cost over $80 million.
The Alliance for Science recently attended the BIO International Convention in San Francisco and interviewed Ron Stotish, chief executive officer of AquaBounty, to learn more about navigating the federal bureaucracy.
AfS: What was actually approved in November 2015?
RS: A fertilized salmon egg which will grow to market weight in about half the time compared to a typical salmon.
AfS: What agency handled the review?
RS: The overall process was regulated under the Federal Food, Drug and Cosmetic Act, much as any animal drug might be regulated. So the existing framework was modified to review the food safety and environmental safety of a novel food product.
AfS: Your discussions with the feds began in 1995. Then what?
RS: The FDA did not issue their requirements for review and approval of a product like this until 2009. The time between 1995 and 2009 was taken up by stakeholder meetings, discussions and debates on issues like, who should regulate? What agency should be involved under what legislation? And so forth, and so on.
When the FDA finally released their guidance documents in 2009 then the regulatory path became clear, and we began working in earnest with FDA to meet their requirements for approval of a food animal created using recombinant DNA, or biotechnology.
AfS: What did that entail?
RS: There's a great deal of misunderstanding about exactly what the regulatory process is.
In this case, the FDA — specifically, the Center for Veterinary Medicine, that part of the FDA which regulates animal health — requires that you demonstrate safety to the animal, safety to the consumer, and safety to the environment.
To that end, you have to supply specific studies that are conducted under a compliance network of good laboratory practices, good clinical practices and good manufacturing processes, and that demonstrate the integrity of your process and the safety of each of those characteristics.
So you might spend two or three years, $100,000 to $200,000, running a well-designed study that they've approved the protocol for, maybe with a contract lab, maybe in your own facility. It's audited by the quality assurance people. It's submitted to the FDA. They take maybe six months or a year to review it.
They tell you if they have any questions or if they accept the data, and whether they accept the statistical analysis. It's a very well-defined, very thorough, escalating risk-assessment process. That's not onerous for companies. We understand the importance of being able to reproduce those studies, and the integrity of those studies.
AfS: Is the regulatory process for GMO foods adequate?
RS: One of the most successful strategies that the activists have used over the years is questioning the validity of the data, the safety of the technology, the credibility of the scientists performing the work, and even the credibility and integrity of the regulators that reviewed the data. Much of that has been subjective. Much of it has been manufactured.
The reality is that this is probably one of the most intensively regulated and overseen aspects of any aspect of regulated products in the United States. The regulatory process that was used for AquAdvantage is the very same regulatory process that is used to approve human medicines and animal medicines in the United States.
The studies are done under a highly-regulated and enforced compliance, and all the studies are audited. There are unannounced site visits by FDA, which inspects the facilities, the SOPs, [standard operating procedures], the staff, the operation of the facilities, and all of the other requirements that we have to adhere to.
We're inspected by roughly seven regulatory agencies between the United States, and Canada, and Panama presently. And the comparison with the traditional food industry to our salmon industry is they have zero inspections and zero oversight.
AfS: How does the regulatory process for a GE food compare to a non-GE food?
RS: What products do you serve your family that you know that you can trace not only the origin, but also the parentage back for 12 generations, of the fish that you might serve them for dinner? This is an unprecedented level of oversight and regulation, and it's completely over the top in terms of a comparison with the traditional food production.
Much of the seafood that we import from places around the world comes from places where we probably could have very serious health concerns about the use of unapproved products, or environmental pathogens that don't exist in the United States that may be common in those areas. And yet, we import 90 percent of our seafood.
AfS: How has the long, costly regulatory process affected the advance of this technology?
RS: The concern prior to our approval was that the delays and the process were flawed, that the requirements were irrational, and they were being driven by organizations outside the regulatory process which had a vested interest in preventing new product introduction.
So it basically killed investment, and it killed innovation of new products. And much of the technology that was developed in the United States in the '70s, and '80s and '90s actually went to other countries.
The delay of the regulatory review process prior to the approval of AquAdvantage was perceived by many as sort of a dead end in the United States for this technology.
The approval of AquAdvantage provides hope that now, in the United States, the science-based regulation is meaningful and will continue to be implemented. And in fact, since our approval there have been three or four other approvals of products using similar technology.
AfS: Were there any caveats to the approval of the salmon?
RS: There were the same requirements that we were aware of — that our product be grown in land-based facilities; that the characteristics of the product were such that it would not affect biological diversity, not interact with wild species, and would basically be produced in land-based facilities with very high accountability and very high regulation.
It includes a fairly expensive compliance platform, because unlike other components of the food system, we're regulated much as a drug production site would be regulated. So we operate under good laboratory practices, good manufacturing practices. It's a fairly expensive support system to operate.
AfS: Are 20 years and an $80 million price tag standard for this type of regulatory review?
RS: That should not be typical and is not typical of a product like this. The regulatory review and the delay certainly added to the expense. But we're hopeful that there is a path available now for scientific review and approval of product applications based solely on their merit, and not in a protracted public process that can delay approval and be costly and expensive to the sponsor.
AfS: Do you oppose a regulatory process?
RS: Companies actually have a vested interest in having a robust and rigorous regulatory process. That prevents the pirates, the unethicals and all of the other people who might try to exploit this, from entering products into the market which aren't safe. There are, interestingly, examples of products in the United States that aren't regulated — beauty aids, health products, natural products, a lot of these things.
In this instance, we have a highly-regulated, well-defined regulatory process that establishes everything from the safety to the animal, to the safety to the environment. And firms are glad to provide that data and work with regulators who are the independent ombudsmen or referees, or reviewers. They are the representatives of society that say, "This science is solid. This product is safe."
And when they [regulators] sign off they are signing off with the knowledge that if they've made a mistake they are also culpable, and they will be grilled and crucified in the public domain if they have made a mistake. So they're very, very cautious, but they take their job very seriously, and the companies are willing, and frankly glad, to provide that data.
AfS: So you still support the process?
RS: It's not the existence of the regulatory process that's the problem. It's when the regulatory process and the science-based review process is not allowed to work, and that was our experience.
Interestingly enough, some of the objections that were raised by some of the opponents of AquaBounty and AquAdvantage were raised in 2010. The FDA answered those publicly at the time of our review. But those same accusations are still being made today, even though they were addressed by the regulators and the agencies six years ago.
AfS: How did you keep going through the delays and the expense?
RS: The short answer to how we kept going is with great difficulty. We were always painfully honest with our board, and we were always painfully honest with our shareholders. We worked diligently, conscientiously and professionally with the regulators, patiently understanding that their job was also difficult because the same people who were attacking us were attacking them.
AfS: Do you see room to change the GE regulatory process without sacrificing safety?
RS: The opportunity to change the regulatory process is obvious and immediate.
Normally with a regulatory process, as your experience with the regulated industry and the technology is accumulated, the regulatory policy adjusts. So after a 25-year experience with zero adverse effects, food safety effects or legitimate food safety concerns, you would think that the regulatory policy would adapt to that and become more efficient.
That, in fact, has not happened. If anything, it's become more rigorous.
In the case of animals, we're now reviewing and approving the creation of a food animal with the same rigor that we are reviewing an approval of a medical drug or an animal veterinary drug. And in our case, because we're the first, that's understandable.
But one would hope that with experience, that the regulatory agencies would acknowledge the fact that when the company submits data showing that the gene construct is safe and that the sequence is maintained over multiple generations, and that the composition of the food is the same that that should facilitate a reasonable review, an efficient review. That is my hope. In a common sense world, that is what would occur.
Unless and until we deal with this negative perception that's being created by activists, we will continue to have a very expensive, very time-consuming regulatory process. If it becomes a process only of referendum, or a consensus by the public, we will never, ever approve another new product in any aspect of our lives.
The regulatory process cannot be subject to arbitrary political pressure from groups that have a vested interest in preventing new technologies from being introduced. Unless we recognize that, and deal with that effectively as a society, I think this will be a continuing problem.