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USA: Dispute over the approval of genetically modified salmon

(23 September 2010) The possible approval of genetically modified salmon has led to vigorous dispute in the USA. The recommendation by experts that that further testing be conducted for the time being was the conclusion of a hearing arranged by the American Food and Drug Administration (FDA) and echoed broadly in the media. The salmon would have been the first genetically modified animal approved for human consumption.

The GM salmon (known under the brand name AquAdvantage) is exactly as safe as other salmon types, according to the results of a recently concluded safety assessment by the FDA. In its material composition, foodstuff derived from the salmon in question was indistinguishable from conventional salmon products. According to the same report, the possible endangerment of wild salmon could be ignored since the GM salmon would be kept exclusively in farms at great distances to coastal regions. Furthermore, since only sterile female fish are intended for use, reproduction would remain impossible even if GM salmon were to escape into open water.

To solicit opinions of external experts towards the result of the safety assessment, the USDA organised a public hearing with its own responsible scientific advisory committee. The hearing took place on the 19th and 21st of September in Washington.

At close of the two-day discussions, the committee chairperson declared that the majority of experts assume the GM salmon to be safe. However, the chair also noted that reservations exist since the data basis of specific studies could be regarded as too low and that, consequently, further tests should be performed. In particular, representatives of consumers’ organisations had cited insufficient testing of the GM salmon with regard to allergy risk.

Although the committee vote is only advisory in character, most observers do not continue to reckon with speedy approval from the FDA.

If GM salmon does achieve approval for market entry, the labelling of is derived products would be another point of conflict. To address the issue, the FDA will convene another public hearing. In its statement of position, the Agency has declared that label reference to process-related gene technology would be fundamentally incompatible with current legal regulations in the USA.

In contrast to European practice, labeling in the USA is oriented strictly towards the material composition of a food product, irrespective of the processes used in its manufacture. In most cases to date, the changes achieved through gene technology on plants have not changed the material composition of the food produced from them. Specific labeling is therefore not required in the USA and, according to the FDA, this condition also would apply to AquAdvantage salmon.

AquaBounty, the company that intends to bring GM salmon to market, rejects the voluntary labeling of food products made from the fish. According to AquaBounty president Ron Stotish, "Such labeling misguides the consumer since it suggests distinctions that do not exist in fact."

AquaBounty applied for approval already in 1995. Due to two newly introduced genes from other fish, growth hormone is produced in the salmon not only in times of warmer water temperatures but during the whole year. The result is that the fish grow twice as quickly as conventional fish of the same type and may therefore be processed earlier.

The FDA reopened the approval process only two years ago, after legal guidelines for food products from genetically modified animals became operative in the USA.


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