In its continuing benchmarking search for scientific breakthroughs and innovations, the DOST-Biosafety Committee (DOST-BC) invited Dr. Mark Walton from AquaBounty, USA to discuss about the “Genetically Modified Salmon Technology (GM Fish) and Regulatory Approval Experience” during the 141st DOST-BC meeting held last 24 April 2021 through Zoom platform.

Dr. Mark Walton has served as the AquaBounty Chief Technology Officer (CTO) since 2019. Prior to becoming CTO, Dr. Walton served as the Global Director of Regulatory Affairs. He began his career in agriculture biotechnology in the 1980s, and in 1990 started Linkage Genetics, the first DNA testing company to provide molecular marker services to plant and animal breeders. Dr. Walton is deeply involved in the on-going discussions between industry and governments on the regulation of genetically engineered livestock and played an active role in obtaining the Cloning Risk Assessment and the Guidance on Regulation of Genetically Engineered Animals from the US Food and Drug Administration. He earned his Ph.D. in Agronomy from the University of Nebraska – Lincoln.

The growing need for a new solution for food production has been the driving force of AquaBounty, seeking sustainable solution that would mitigate the abrupt reduction of protein more specifically on salmon fish. In Dr. Walton’s brief overview, he quoted that 90% of the world’s fisheries are fully fished or overfished based on the facts stated on the FAO’s The State of World Fisheries and Aquaculture 2020.

With the immense increased of global population projected at 9 billion people by 2050, the demand of protein will outlast the supply, thus, the need to create a remarkable and sustainable solutions is a must.

Given the present situation, Dr. Walton stated that marine-based proteins are gaining a growing market share. In this respect, aquaculture must produce nearly 60 million additional tons of fish by 2050 (more than double in 2010) to fill the seafood gap.

In addressing the projected seafood gap, Dr. Walton presented a three-step approach to address the forthcoming increase of the demand of salmon:

  1. Shift salmon production to land-based aquaculture system
  2. The use of fresh-water tanks and technology to nurture the fish in a safe and sustainable way
  3. Use of genetically engineered Salmon for faster growth to harvest weight, resulting in a 1.7x increase in harvest with 25% less feed input compared to conventionally grown Salmon

AquAdvantage Salmon (AAS) has been genetically engineered to achieve their mature weight faster than the conventional non-transgenic salmon. It contains an rDNA construct that is composed of the growth hormone gene from Chinook salmon under the control of a promoter from ocean pout anti-freeze protein gene. This allows the salmon to grow faster.

To reduce the potential of genetic mixing between traditional salmon and AAS, strict regulations force the company to grow its AAS in land-based Recirculating Aquaculture Systems ("RAS"). RAS offers several advantages over conventional farming: less feedfewer parasites and diseases, no antibiotics, and 98% re-used water.

Currently, the company operates three salmon farms, both in the U.S. and Canada. Two of these are for the commercial growth of salmon, and one of them for R&D purposes.

Dr. Walton also provided a comparative sample wherein he featured the benefits of Controlled Operations to Sea-Cage farming.

  1. Faster Growth which leads to a reduced environmental impact
  2. Lower Carbon Footprint. Greater than 95% water recycled and reduced transportation to consumption
  3. The efficient use of resources and waste utilization as agriculture fertilizer
  4. 25% improvement in Feed Conversion Rate
  5. Physical / Biological Containment
  6. No Chemicals or Antibiotics. This also reduced the risk of infections commonly seen in sea-cage farming

As part of the regulatory approval process, AquaBounty Technologies Inc. provided extensive data for review by regulators of both the United States Food and Drugs Administration (US-FDA) and the Canadian Food Inspection Agency (CFIA). The submitted data included a detailed description of how AquAdvantage Salmon was developed, how the rapid growth during early life trait functions and nutritional composition of the fish. Regulators also accessed relevant peer-reviewed studies from the published literature.

Both the US and Canada's regulatory framework requires the product developer to generate the data necessary to fulfil the requirements of the safety and nutrition assessments. This approach to data generation is consistent with that of regulatory bodies around the world for products of biotechnology and other types of products such as drugs.

Under FDA regulation, Aquadvantage Salmon is treated under the New Animal Drug Paradigm. Risk assessment was conducted on

  • Human food safety
  • Animal health and welfare
  • Environmental impact

On the other hand, there are three regulatory frameworks under the Canadian Regulation. These are: New substances, Novel food, and Novel feed, with the involvement of three agencies, namely:

  • Environment and Climate Change Canada
  • Health Canada (Novel Food)
  • Canada Food Inspection Agency (Novel Feed)

Both authorities, however, came to the same conclusion/findings that:

  • AquAdvantage Salmon is not different than non-transgenic salmon
  • Comparable physiology and morphology
  • Comparable nutritional composition
  • Must be grown in land-based, contained facilities

In conclusion, the production of GM Salmon meets the overarching demand of protein food that is expected in the near future without compromising the health of the consumers and safeguarding the environment. These scientific breakthroughs are the key in living a sustainable environment. #