SHRIMP: Success Story

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Issue

Approach

Solution

Result

The Problem

There continues to be increased production of aquaculture or “farm raised” seafood products throughout the world. The US imports approximately 80% of the seafood its population consumes. Aquaculture seafood accounts for over 40% of these imports. Chinese aquaculture accounts for approximately 70% of global production. Concerns have arisen over certain aquaculture drugs that are used in raising seafood. Specifically, the US FDA has listed malachite green, gentian violet, nitrofurans, and fluoroquinolones drugs as a “high enforcement priority” due to the fact that several of these drugs have been shown to have carcinogenic affects in humans.

The US FDA published Import Alert 16-131 within the last five years that prohibited the presence of these aquaculture drugs in imported seafood from China. Each container imported into the US must be tested by an independent third party laboratory for these drugs before it is released into commerce. Each container is placed in cold storage until the results of the tests are received and reviewed by the FDA. Once the results of the tests have proven negative, the FDA will release the product. The importer is faced with one important issue: the time required between receipt of the product at port and the release at the cold storage facility. The importer must pay for time at the cold storage warehouse as well as the opportunity or holding cost of product that cannot be sold.

The Approach

ABC Research Laboratories developed a Detention Resolution Packet “DRP” to provide importers with all of the forms required by the FDA along with the scientific documentation required to support the test results. ABC sought the expertise and guidance of Bruker Corporation, a multinational manufacturer of scientific and chromatographic instrumentation. After several months of discussion and demonstration, Bruker provided an ideal solution to provide accurate, timely results via the Bruker amaZon SL Ion Trap Mass Spectrometer.

The Solution

The FDA reviews, in detail, the DRP prior to releasing the product into commerce. In order satisfy the FDA reviewer’s validation requirements ABC must successfully reproduce the FDA’s methodology detailed in the FDA’s Laboratory Information Bulletins (LIBs). In doing so, ABC must demonstrate acceptable instrument sensitivity via recoveries of analyte in samples fortified at the limit of quantification (LOQ). The LOQ must meet, at a minimum, the levels listed in the LIBs. Coupled with ABC’s chromatographic expertise, the Bruker amaZon SL Ion Trap Mass Spectrometer is able to consistently meet or exceed these LOQ requirements. When results are finalized, the DRP is completed immediately and forwarded to the appropriate parties electronically or by overnight courier.

The Result

ABC Clients who are under FDA Import Alert 16-131 have a dedicated team of scientists and client service professionals who recognize the urgency of releasing every container detained by the FDA. Through our DRP, clients simply contact us one time to let us know where their samples are anywhere in the US and the process begins immediately and is seamless to the client. The entire process from sampling to submittal of results to the FDA is always accomplished within five to seven days. This turnaround time is the best in the food testing industry and saves our clients the frustration of dealing directly with the FDA as well as minimizing the opportunity and real costs of detained product.

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