Aquaculture North America

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New FDA rule triggers issues on how to tag and trace


The US Food and Drug Administration (FDA)’s proposal last September to require additional traceability recordkeeping is likely to change how shellfish farmers and distributors tag and track crops. The FDA is taking comments until January 21, 2021.

The rule introduces new key data elements associated with different critical events. It applies to oysters, clams, and mussels, but not scallop abductor muscles.

For farmers like Duane Fagergren, who runs a small family operation in Washington State with his daughter Eve, the proposed rule created a quandary: place another order of pre-printed tags to be filled out by hand or try a new digital system.  “Cost seemed a toss-up,” he says.

For their operation, Calm Cove Oyster Company, Fagergren chose the digital system launched by Oyster Tracker last spring and already in use at 50 farms.  He enters information on his iPhone, which is then stored in the Cloud.  A small, weather-resistant portable printer lets him print out a tag with a QR code that “makes regulators happy with the chain of custody.”  And if requirements change again, he isn’t stuck with outdated tags. Oyster Tracker will easily make the edit.

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Although Fagergren says “change is challenging,” he adds, “This has probably been the best business investment we made this year.” 


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