21 November 2015

Patented ‘Frankenfish’ Finally Granted FDA Approval

Salmon SushiOn 19 November 2015, the US Food and Drug Administration (FDA) approved, for the first time, a genetically engineered food animal.  Of course, there have previously been many genetically engineered food plants approved for production and consumption, such as Monsanto’s ‘Roundup Ready’ crops.  And animals have been genetically engineered and commercialised for other purposes, such as the Harvard OncoMouse for use in cancer research.

The animal in question is a fish.  More precisely, it is a genetically engineered salmon, developed by a company called AquaBounty Technologies under the brand name AquAdvantage.  AquaBounty claims that its salmon grow to full size in half the time of ‘regular’ salmon (18 months, as opposed to three years), are larger, require 25% less feed, and grow at a 1:1 ratio of feed mass to body weight. 

Of course, the positive spin on this is that farming AquAdvantage fish is more sustainable than other forms of salmon production.  However, the primary beneficiaries, at least initially, would be the producers who are able to grow and bring to market more fish in less time at lower cost.  If, that is, they can convince the consuming public to buy a product that has been emotively labelled ‘frankenfish’ by its detractors.

Patent – Expired Before Approval!

Not surprisingly, the AquAdvantage salmon was patented.  However, the operative word here is ‘was’, because US patent no. 5,545,808, entitled ‘Transgenic salmonid fish expressing exogenous salmonid growth hormone’, expired on 13 August 2013.  The FDA approval process took about 20 years to complete, not least due to the novelty of reviewing a transgenic animal, and the broad public concern generated by the issue. 

As with transgenic plants, the FDA had to consider safety and nutrition for consumption, the truth of the claims made for the product by AquaBounty, as well as potential impact on the environment.  Additionally, however, the safety of the genetic modification for the fish itself had to be considered.

Although it appears that AquaBounty will gain no direct commercial benefit from its now-expired patent rights, the patent itself is interesting for what it reveals about the way in which the salmon is ‘made’, and how such ‘technologies’ can be protected.  The patent claims cover both ‘a method of increasing the growth rate of a salmonid fish’, and ‘a transgenic salmonid fish’.

What the Patent Covered

Essentially, the method described and claimed in the patent involves introducing a modified gene into the germ line of a salmonid fish (Atlantic salmon, to be more precise).  In practice, DNA in fertilised eggs is modified and the resulting fish therefore carry the modification.  The independent claim covering the fish itself defines it as follows:
  1. A transgenic salmonid fish containing in its germline a salmonid growth hormone gene operably linked to a type 3 antifreeze protein promoter wherein said salmonid fish expresses said growth hormone gene at levels which increase the rate of its growth at least four times that of a salmonid fish lacking said growth hormone gene operably linked to said antifreeze protein promoter.
The fish is thus modified to produce more growth hormone than a natural salmon, which leads to its enhanced growth rate.

Continuing Challenges

The commercial AquAdvantage salmon are also all female and sterile.  This has environmental benefits, in that should any transgenic fish somehow escape into the wild, they could not reproduce and have any wider environmental impact.  However, it also has an obvious commercial benefit, in that transgenic eggs or juvenile salmon can be sold to farmers secure in the knowledge that the resulting fish could not be bred and erode the market for transgenic stock.  (The OncoMouse is also sterile, despite the fact that an enhanced propensity to develop cancer is not a characteristic likely to be favoured by natural selection!)

However, despite receiving the FDA’s approval, the battle for AquaBounty to bring its product to market is not yet over.  The Canadian AquAdvantage salmon egg production facility is at the centre of a legal challenge based upon the risk it allegedly poses to the environment (despite the fish being sterile), while the non-profit Center for Food Safety immediately announced its intention to launch a legal challenge against the FDA decision. 

FDA’s Limited Approval

Interestingly, although the FDA has approved AquAdvantage for sale and consumption in the US, it has also stated that:

The AquAdvantage Salmon may be raised only in land-based, contained hatchery tanks in two specific facilities in Canada and Panama. The approval does not allow AquAdvantage Salmon to be bred or raised in the United States. In fact, under this approval, no other facilities or locations, in the United States or elsewhere, are authorized for breeding or raising AquAdvantage Salmon that are intended for marketing as food to U.S. consumers.

Another interesting aspect of the FDA approval is that AquAdvantage has effectively been approved as a ‘drug’ rather than as a ‘food’, although I understand that this is something of a technicality – there is no suggestion that consuming transgenic salmon has any pharmacological effect on humans.  On the contrary, one of the requirements for FDA approval is that the genetically engineered product has no ‘biologically relevant differences’ in nutrition compared to the natural equivalent.  What the FDA statement actually says about this is that:

The FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act, because the recombinant DNA (rDNA) construct introduced into the animal meets the definition of a drug. In this case, the rDNA construct introduces a trait that makes the AquAdvantage Salmon grow faster.

Conclusion – Controversial Products, Controversial Patents

Genetic technologies continue to generate controversy, for a wide variety of both good and bad health, safety, environmental and ethical reasons.

For as long as this continues to be the case, patents which grant exclusive control over such technologies to private interests will doubtless also remain controversial.  In this broader context, the Myriad BRCA gene patent – which provided broad rights over genetic information useful in detecting susceptibility to breast and ovarian cancers – was ‘low-hanging fruit’ for opponents of the patenting of genetic technologies.  I doubt very much, however, that the debates, lobbying and legal challenges in this field are over… not by a long way!


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