Genetically modified organisms or GMOs have been a controversial topic for decades. Scientists have been manipulating genes to create crops that resist pests or produce certain nutrients.

When it comes to animals, genetic engineering has been more challenging but also more rewarding. One of the latest achievements is the genetically modified salmon which has been deemed safe for consumption by the US Food and Drug Administration or FDA.

This decision has significant implications for the fishing and agriculture industries, as well as for consumers who are concerned about the safety and sustainability of their food.

What is Genetically Modified Salmon?

Genetically modified salmon is a type of fish that has been altered at the genetic level to grow faster and bigger than wild salmon.

The genetic modification involves inserting a gene from the Chinook salmon and a promoter from the ocean pout into the Atlantic salmon. The former gene triggers the growth hormone in the latter, while the latter promoter activates the gene only in the presence of cold water.

This means that the genetically modified salmon can reach maturity in half the time of wild salmon, which makes them more efficient to farm and harvest. The additional growth hormone also makes them up to 70% bigger than their wild counterparts, which means that they can produce more meat with less feed.

However, genetic modification also raises concerns about the effects on the salmon’s health, behavior, and environment. Some experts worry that the added growth hormone may cause deformities, diseases, or other negative effects on the salmon.

Others argue that the escape of GM salmon into the wild may disrupt or endanger wild salmon populations, either by outcompeting them for food or mates or by interbreeding with them and diluting their genetic diversity. Moreover, there are concerns about the impact of GM salmon farming on the marine ecosystem, such as the use of antibiotics, pesticides, or other chemicals that may pollute the water and affect other aquatic animals.

These concerns have divided public opinion and led to various legal and regulatory debates.

How Did the FDA Evaluate the Safety of Genetically Modified Salmon?

The FDA has been reviewing and regulating genetically engineered animals since 2008, when it issued its guidance on the regulation of animal biotechnology.

According to this guidance, any genetically engineered animal that is intended for human food must undergo an extensive analysis of its safety, efficacy, and environmental impact. This analysis involves several steps, including the following:.

Step 1: Identifying the Purpose of the Genetic Modification

The FDA requires the developer of a genetically engineered animal to specify the intended benefit or traits of the animal, as well as the molecular and genetic methods used to achieve those traits.

In the case of GM salmon, the purpose of the genetic modification was to increase their growth rate and size, thereby reducing the time and resources needed for their farming and harvesting.

Step 2: Assessing the Potential Hazards of the Genetic Modification

The FDA requires the developer to identify and evaluate any potential risks or hazards associated with the genetic modification, both to the animal itself and to the environment.

This assessment may include studies on the toxicity, allergenicity, and bioactivity of the gene product, as well as the potential for horizontal gene transfer or impact on non-target species. In the case of GM salmon, the FDA conducted a comprehensive analysis of the data and information provided by the manufacturer, including over a decade of research and testing, to determine the extent and likelihood of any potential hazards.

Step 3: Designing and Implementing Appropriate Controls

The FDA requires the developer to implement appropriate controls to ensure that the genetically engineered animal is safe and effective for its intended purpose.

These controls may include measures to contain or mitigate the risks, such as biosecurity, monitoring, and traceability. In the case of GM salmon, the FDA required several conditions and controls to be met by the manufacturer before approving the product, such as:.

Requiring the GM salmon to be grown only in land-based tanks and facilities that are physically and biologically secure to prevent escape or release into the wild;
Requiring the GM salmon to be female and sterile, which means that they cannot breed or produce offspring;
Requiring the GM salmon to be labeled as such to enable informed consumer choice and avoid any potential public concerns or confusion.

Step 4: Monitoring and Assessing the Performance of the Genetically Engineered Animal

The FDA requires the developer to monitor and assess the performance of the genetically engineered animal after it has been approved and marketed.

This monitoring may include post-market surveillance, data collection, and reporting to detect and address any unforeseen or adverse effects that may arise.

In the case of GM salmon, the FDA has required the manufacturer to submit annual reports that describe the ongoing monitoring and surveillance activities, as well as any new data or information that may affect the safety or effectiveness of the product.

What Are the Implications of the FDA’s Decision on Genetically Modified Salmon?

The FDA’s decision to approve the genetically modified salmon for human consumption has been both praised and criticized by various stakeholders.

Supporters of GM salmon argue that it offers numerous benefits to the fishing and agriculture industries, as well as to consumers who want safe, nutritious, and sustainable seafood. They also claim that the scientific evidence and regulatory process have ensured the safety and efficacy of the product, and that labeling alone is sufficient to inform consumers and address any concerns.

Opponents of GM salmon disagree and warn that the approval sets a dangerous precedent for the regulation of genetically engineered animals and may have unintended consequences for human health, animal welfare, and ecosystem integrity.

They cite various scientific studies and reports that question the safety and sustainability of GM salmon, as well as potential risks to wild salmon populations and the marine environment. They also demand more transparency and public input in the regulatory process, as well as more comprehensive labeling and traceability requirements.

Overall, the FDA’s decision on genetically modified salmon is likely to have far-reaching implications for the future of food production and consumption, as well as for the governance and ethics of biotechnology.

It raises important questions about the balance between innovation and caution, risk and benefit, science and democracy, and individual and collective interests. It also highlights the need for more collaborative and inclusive approaches to assessing and regulating emerging technologies that affect our food, our health, and our environment.