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.

SGS is committed to keeping you informed of regulatory news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical testing, audits, certifications, inspections and technical support. We continually invest in our world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality. For further information, please visit our website:

For enquiries, please contact:

James Cook
Food Scientific and Regulatory Affairs Manager

t: +01 973 461 1493

Stay on top of regulatory changes within your industry: subscribe to SafeGuardS!

© SGS Group Management SA - 2016 - All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.