FDA announces approval of fast-growing genetically engineered salmon

gm_aquadvantage_salmon

The Food and Drug Administration have announced the approval of a genetically engineered salmon produced by AquaBounty Technologies Inc, making it the first time a GE animal has been approved for human consumption worldwide. The salmon is engineered to grow faster than either conventionally farmed or wild salmon

 

Dr. William Muir, Professor Genetics, Department of Animal Sciences, Purdue University (webpage):

Expertise: Breeding and Genetics; Poultry and Aquaculture; Biotechnology Risk Assessment.

“I view the announcement of the FDA to approve the AquaBounty GE salmon for production in land based system as a huge win-win for the environment, consumers, and the process! The scientific review is clear, there is no credible evidence that these fish are a risk to either human health or the environment. In contrast, the current practice of using wild caught salmon as a food source is not sustainable, our oceans are over fished. This development provides a safe and sustainable alternative. Further, this opens the door for the use of biotechnology as a tool to improve US food production in other species and in other ways to help feed a growing population. This GE technology has been on hold for over a decade waiting for confirmation that the process works, i.e. that the FDA can regulate product of biotechnology through use a rigorous scientific method or be constrained by political considerations. The answer is now clear, the process works, and all sectors will benefit.”

 

Dr. Alison Van Eenennaam, Animal Geneticist in the Department of Animal Science at the University of California, Davis (webpage):

Expertise: research and education on the use of animal genomics and biotechnology in livestock production systems. Dr Van Eenennaam was a member of the September, 2010 FDA Veterinary Medicine Advisory Committee which looked at the AquaBounty salmon.

“The AquAdvantage salmon was originally developed as a fast-growing variety of salmon by a group of Canadian public university scientists over a quarter of a century ago. It is not unusual for breeders to select for fast-growing, productive plants and animals. Unique to animals bred using one breeding method (genetic engineering), however, is a lengthy and expensive regulatory process. AquaBounty has been attempting to get regulatory approval for the AquAdvantage salmon for almost two decades. Five years ago FDA scientists determined that the food from AquAdvantage salmon was ‘as safe as food from conventional salmon’ and that the proposed physical, biological and genetic confinement of the fish in the highlands of Panama posed minimal environmental risk. The unexplained five year delay in the FDA’s regulatory decision regarding the AquAdvantage was unprecedented and today’s decision is long overdue.”

 

Dr. Eric Hallerman, Professor of Fish Conservation, Virginia Tech University (webpage):

Expertise: Genetics of fish and wildlife species; Genetic improvement of aquaculture stocks; Aquaculture biotechnology and related public policy. Dr Hallerman was the principal investigator for a U.S. government-supported project quantifying environmental risks posed by the AquAdvantage salmon.

“Today, the FDA Center for Veterinary Medicine has approved the application for marketing in the United States of food products from the AquAdvantage salmon, a genetically modified Atlantic salmon produced at specified facilities in Canada and Panama. This approval follows extensive review of food safety and environmental safety under the authority of the U.S. Food, Drug and Cosmetics Act. The action allows pilot-scale production at these specific facilities, which will be critical for quantifying the economics of production and the efficacy of confinement. Yet, the significance of the action is that it marks the first approval globally for production of genetically modified animals for purposes of food production and sale.

“Today’s action is significant for another reason, as FDA also announced draft guidance on the voluntary labelling of food derived from the product. Much controversy has focused on whether and how foods derived from biotechnology should be labelled. While studies have shown that salmon products derived from the AquAdvantage salmon are no different from those derived from conventional production, some consumers have argued for a ‘right to know’ how food products were produced.”

(Dr. Hallerman’s original comment mistakenly said AquaBounty would be labeling its products. This has been corrected.)

 

Dr. J. Andrew DeWoody, Professor of Genetics and University Faculty Scholar, Purdue University (webpage):

Expertise: Evolutionary genetics and genomics; molecular ecology and evolution; natural history; conservation biology; wildlife and fisheries management.

“I’ve heard of AquaBounty salmon for many years, and it appears they have finally cleared some important regulatory hurdles in the U.S.  I’ve never had any real concerns about the safety of these genetically engineered salmon as a food source.  I see no reason to worry about human health effects and apparently neither does the FDA.  However, I’ve always had concerns about the potential environmental effects should these GE fish escape into the wild because of their potential impact on native gene pools.  That said, I was pleased to learn that the GE fish will be sterile, landlocked, and surrounded by multiple physical barriers.  The onus now falls on AquaBounty to maintain their physical facilities and on regulatory agencies to continually monitor the integrity of these safety measures into the foreseeable future, because U.S. waters have been negatively impacted by other species (such as carp) that escaped from containment ponds.”

 

Dr. Mark Abrahams, Dean of Science & Professor, Department of Biology / Ocean Sciences, Memorial University of Newfoundland (webpage):

Expertise: interactions between predators and their prey, primarily focussing on fish, and the impact this has on the ecosystem. Dr. Abrahams published the following paper regarding the AquaBounty salmon: ‘The foraging and antipredator behaviour of growth-enhanced transgenic Atlantic salmon‘.

In my opinion, the review process undertaken by the FDA has been extremely thorough so I think it reasonable to assume that the conclusions they have drawn and the recommendations they have made are well supported by the evidence. From that perspective there is no evidence that these fish pose a risk to human health but time will tell whether they will be accepted by consumers.”

 

Dr. Garth Fletcher, Professor Emeritus and Head of the Department of Ocean Sciences, Memorial University of Newfoundland (webpage):

Expertise: Antifreeze proteins and cold adaptation in fish. Dr. Fletcher along with Dr. Choy Hew hold the US patent on transgenic salmon. Dr. Fletcher was also a founding member of AquaBounty and worked with the company for approximately 10 years supervising much of the research required by FDA for regulatory review.

“This is exciting news both for AquaBounty and for me. It has been a long time coming, but many years of hard work have finally come to fruition. This product started out in 1989 when two academic faculty members at Memorial University of Newfoundland (myself and Choy Hew) decided see if we could enhance the growth rates of Atlantic salmon.  Early in 1990 we realized that our work had been successful when we observed growth rates that greatly exceeded everyone’s expectations. At that time NSERC (Natural Science and Engineering Research Council of Canada), which funded the project, had started promoting the idea that academics should get involved in transferring research discoveries to the private sector. Fortunately for us we met up with Elliot Entis, the CEO of a start-up biotech company, who agreed to licence the invention from our respective universities. This brought in the necessary funds to complete the years of research required to document that the product was safe to eat and safe for the environment.

“This approval is good news for all academic researchers interested in genetic modification of animals being bred for human consumption. The pioneering efforts of AquaBounty working with FDA regulatory authorities has demonstrated that with care, good science, and patience, innovative research in this somewhat controversial field can be taken from the laboratory bench to the market place.”

 

Dr. Rex Dunham, Professor, School of Fisheries, Aquaculture and Aquatic Sciences, Auburn University (webpage):

Expertise: genetic improvement of catfish: selective breeding, hybridization, gene transfer, gene mapping and genomics and reproductive physiology. 

I believe this ruling by FDA is positive. These fish have been thoroughly examined over a very lengthy process that I think was actually initiated about 20 years ago. The US National Academy of Sciences, The Royal Society of London and FAO/WHO have all established panels in the past that all concluded that transgenic meat in almost all cases would be expected to  be as safe as non-transgenic meat, corroborating FDA’s decision. The exceptions would include cases where a gene from corn, shellfish or nuts could elicit a potential allergic reaction.

“This ruling is important to make aquaculture more productive and efficient. Technologies such as this are important as the population of our planet continues to grow, and requires more protein with increasing demand for fish. It is important to be able to increase production and efficiency using as small a footprint as possible, and genetic engineering is an important tool to accomplish this. From an economic standpoint, it is inevitable that other countries will implement this technology and it is important for the US and North America to remain competitive. This is actually another food safety positive for Americans as little of our imported fish is inspected and often contains unhealthy compounds. Utilizing technologies that reduce imports increases the food safety for Americans.

“Environmentally, I also feel that this is positive, as proper implementation of this technology will help reduce the pressure on wild populations of fish.  Companion technologies will eventually and actually help us to protect natural populations from domesticated fish in general as well as exotic species, hybrids and transgenics, making aquaculture more environmentally friendly. It is important to proceed cautiously and responsibly, so the sterilization is an important aspect. The available good scientific data indicates that growth hormone transgenic fish would not be competitive in the natural environment. However, they should be sterilized, as AquaBounty is implementing, to ensure another layer of safety.”

 

Dr. Mart Gross, Department of Ecology and Evolutionary Biology, University of Toronto (webpage):

Expertise: conservation projects with fish; their loss from the wild, their reintroduction by captive breeding programs, and their invasion into new environments where they may impact other species.

“I believe this is a historic decision for the future of human agriculture.

“First, it recognizes that the GMO technology used with the Atlantic salmon is part of the 10,000 year practice of genetic manipulation including artificial selection and artificial hybridization that has made food abundant and sustained a growing human population.  It signals that GMO production is about as natural as anything else done in agriculture to develop improved strains.

“Second, approving the GMO Atlantic salmon opens the application of GMO technology to large numbers of agricultural species to meet continuing and growing demands for more and better food. Thus, the decision creates an opportunity to use modern technology to move genes at a rapid rate in many species which will be useful for feeding a growing human population with increased demands for quality products. 

“Third, the decision shows that the important pressure from environmental groups to meet ecological concerns can be incorporated into decision making, and that there is a role for concern about the environment in deciding how and when modern technology will be applied in agriculture.  Thus the efforts of many environmentalists have been successful: the decision was delayed until more information about environmental impact was analyzed and significant environmental protections were incorporated. I believe that it is unlikely that wild fish populations are at risk if enforcement of the rules is followed.

“Finally, in the Anthropocene the use of GMO production has its place and the FDA’s decision recognizes and supports the use of science for human progression.”

 

Dr. Anne Kapuscinski, Professor of Environmental Studies, Dartmouth College (webpage):

Expertise: sustainable aquaculture; integrated food-energy systems; fish genetic conservation; environmental risk assessment and management of genetically modified fish.

“This approval shows us how the FDA will apply the drug law to more applications to farm genetically engineered salmon. More applications are coming because this first approval applies to a small farm in Panama that will barely make a dent in the global market of farmed salmon. I see incremental improvement in how the FDA applied science in the environmental assessment, but I don’t see the scientific quality required to assess many larger applications.

“This worries me because the drug law forces the FDA to keep secret a genetically engineered animal’s environmental assessment unless the applicant wants it to be public. The environmental impact of this GE salmon approval hinges on keeping it from getting out into nature. The FDA concluded it is environmentally safe because the hatchery in Canada and farming operation in Panama have multiple, complex barriers to escape, but it will be a real challenge to scale up this approach to many and larger salmon farms. This is why my comments to the FDA urged for a quantitative analysis of possible failures in the confinement measures, which are easy to do for this application. I urged the FDA to model the scientific rigor the agency will expect in future applications. The FDA seems to have read my advice but chose to interpret it very narrowly and decided to not require a quantitative failure mode analysis.”

 

Declared interests (see GENeS register of interests policy):

Dr. Alison Van Eenennaam: Dr Van Eenennaam was a member of the September, 2010 FDA Veterinary Medicine Advisory Committee which looked at the AquaBounty salmon.

Dr. Eric Hallerman: Dr Hallerman was the principal investigator for a U.S. government-supported project quantifying environmental risks posed by the AquAdvantage salmon.

Dr. Garth Fletcher: Dr. Fletcher along with Dr. Choy Hew hold the US patent on transgenic salmon. Dr. Fletcher was also a founding member of AquaBounty and worked with the company for approximately 10 years supervising much of the research required by FDA for regulatory review.

Dr. Rex Dunham: I consulted and wrote a white paper for AquaBounty about 15 years ago regarding the food safety implications of elevated GH in Salmon a case study. This was later published in a book I wrote in 2004. Additionally, I wrote and then collaborated with AquaBounty on  a NIST grant that was funded from 2003-2007. The topic was reversible transgenic sterilization in fish.”

No further interests declared

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