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Biotech Salmon Show that Companies Need to be Innovative Not Just to Invent a Product, but also to Get Regulatory Approval and Market Acceptance

March 23, 2020

By Noel Courage

In aquaculture, it took over two decades and $80 million in capital for the genetically modified salmon made by AquaBounty to be developed and approved by regulators for sale in Canada and the US. This article is not to advocate for or against the Aquabounty fish, but provides insight on the challenges of developing and commercializing such biotechnology products. 

The Aquabounty fish was modified with a growth hormone gene that allowed it to reach maturity faster, which is helpful to reduce fish farming costs and time (read about its interesting history starting with Garth Fletcher and Choy Hew at Memorial University of Newfoundland here). Growing fish faster and more efficiently makes sense from a sustainability perspective. Aquaculture also provides an alternative to the often repeated story of overfishing worldwide. Despite the upside, launching a genetically modified fish product into the marketplace requires a complex interaction with government regulators to get approval. First, regulators want detailed information about the product, its testing and safety. It is also important to regulators that the fish be carefully controlled, so that it would not genetically intermingle with wild salmon or non-modified farmed salmon. These particular modified salmon themselves appear to be an extremely low risk to integrate and reproduce with unmodified salmon due to biological controls (growing only sterile females) as well as physical controls (ie. growing on land in caged pens).

In addition to regulatory controversy, modified foods often have shade cast on them by mainstream media. There is also a business challenge in obtaining consumer acceptance of a modified food. Canadian consumers don’t know what food is genetically modified or unmodified and this is acceptable to Canadian regulators. There is no Canadian requirement for labeling of genetically modified foods, because they are considered safe for consumption. A wide array of produce sold in Canada is genetically modified, from corn to canola to soybeans. The lack of labeling may help GMO business, but some consumers would prefer greater transparency. There is a voluntary government standard for those that wish to label as a GMO or GFMO-free. The US does require have a national mandatory standard for disclosing genetically modified foods. Aquabounty plans to label its salmon in the US market, and try to develop consumer acceptance for its GMO salmon.

The challenge to launch a biotechnology product appears to need to be repeated on a country by country basis. Europe would have to approve the salmon as a novel food via the European Foods Safety Authority. Many other countries would also have regulatory requirements to approve the salmon for sale. In the meantime, distributors shipping from Canada internationally to countries where the modified fish are not approved for sale will need to ensure that modified fish are not mixed with unmodified fish, or else the whole shipment could be rejected.

Developing and commercializing a genetically modified food is a significant challenge that goes well beyond the technical aspects of inventing and scaling up the food production. Regulatory and consumer acceptance issues create a significant time, resource and financial barrier to innovative food producers developing GMO’s. Companies will need to build a strong case to show the safety, control and beneficial properties of their products outweighing the downside. Marketing savvy will be necessary to convince consumers to accept the product if it is labeled.

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Author(s):

Noel Courage Noel Courage
B.Sc. (Biochem.), LL.B.
Partner
416.957.1655  email Noel Courage