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SAFEGUARDS | Food NO. 176/16

On September 14, 2016, the US Food and Drug Administration (US FDA) issued a tolerance for the veterinary drug lufenuron in Salmonids imported into the United States, and on September 29, 2016 added six Seafood HACCP videos to their Fish and Fishery Products Hazards and Controls Guidance.

Tolerance for Lufenuron in Salmoninds [1]

The US FDA can legally establish or revoke tolerances for unapproved or conditionally approved animal drugs in food products, as per the Animal Drug Availability act of 1996. On September 14, the US FDA issued an import tolerance of 1.35 ppm (mg/kg) in muscle meat with adhering skin for the veterinary drug lufenuron in Salmonids. Lufenuron is used to control sea lice infestation. [2] At this time, Salmonid products can have this veterinary drug in the muscle meat with skin providing that they don’t exceed the tolerance. The testing procedure for this drug level determination will be performed using a LC-MS/MS methodology. In particular, the US FDA will use LIB method 4463 which is their multi-residue pesticide screen methodology. 

US FDA Six Seafood HACCP Videos

On September 29, 2016 the US FDA issued six seafood HACCP videos to help the industry, State and Federal regulators to better understand the concepts as described in the US FDA’s Fish and Fishery Products Hazards and Controls Guidance. [3]

The videos are:

  1. Time-Temperature Indicators

  2. Time and Temperature Controls During Unrefrigerated Processing

  3. Secondary Processor Receiving and Storage Controls

  4. Heat Process Validation

  5. Primary Processor Scombrotoxin Controls – Overview and Testing at Receiving

  6. Primary Processor Scombrotoxin Controls – Harvest Vessel Records

What Does This Mean For The Food Industry?

The US FDA is allowing a veterinary drug to be utilized to combat sea lice. This drug, at the maximum tolerance, allows the industry to use this drug legally and not use some other drug illegally to combat this problem. The HACCP videos will aid in the understanding of what the US FDA requires from the industry, and allows regulators to know what they are to expect from the industry in order to comply with the US FDA’s requirements.

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Food Scientific and Regulatory Affairs Manager

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