FDA finds Bigelow Laboratory in compliance with standards for first-in-nation shellfish toxin method


April 3rd, 2014 

The U.S. Food and Drug Administration recently evaluated the Bigelow Analytical Services (BAS) facility and found it in compliance with National Shellfish Sanitation Program (NSSP) standards, making BAS the first in the nation to offer a new protocol to test for paralytic shellfish toxins in bivalve shellfish.

“This advance puts Maine at the cutting edge of assessing shellfish safety,” added Bigelow Laboratory’s Executive Director, Graham Shimmield.

The new method replaces the mouse bioassay testing method used for the past 40 years, with an instrumental analysis that measures toxicity levels more precisely and efficiently.

“This is a huge step forward in improving the way shellfish are tested for toxins,” said Carlton Rauschenberg, Bigelow Analytical Services Supervisor. “Paralytic shellfish toxin can be deadly. The quality and sensitivity of data produced by this method far exceeds what the national shellfish program has been able to achieve with the mouse bioassay.”

The result of a partnership between the Department of Marine Resources (DMR) and BAS that started 18 months ago, the testing involves sample collection and extraction by DMR coupled with sample processing and analysis by BAS.

“The new testing protocol also allows the Department of Marine Resources to conduct testing more frequently and with greater flexibility than with the mouse bioassay testing protocol,” said DMR Growing Area Program Supervisor, Alison Sirois. “This flexibility and greater frequency of testing allows the DMR to be more targeted in our closures, which benefits industry by allowing more areas to remain open to shellfish harvesting.”

Officials from the FDA spent three days at BAS and DMR assessing the labs’ equipment, procedures, and ensuring that staff conformed with all requirements associated with the method. The FDA is charged with evaluating labs throughout the country and the world to ensure they comply with NSSP standards and are capable of performing methods approved for bivalve shellfish sanitation. DMR is the state shellfish authority charged with implementing sampling and testing protocols that ensure public health and safety.

“I am extremely proud of the work done both by DMR and BAS in successfully developing this public/private partnership and for leading the nation in transitioning to an accurate and cost effective method for biotoxin analysis,” said Kohl Kanwit, Director of the DMR Bureau of Public Health.

The method being implemented at BAS was first developed collaboratively between Canada’s National Research Council Institute of Marine Biosciences and the Canadian Food Inspection Agency’s Dartmouth laboratory. Similar instrumental methods have been implemented in Australia, New Zealand and throughout Europe. Maine’s rollout will be the first in the United States. With FDA’s successful evaluation of BAS and DMR, it is expected that other states will follow Maine’s lead.

The Maine DMR and Bigelow Laboratory for Ocean Sciences have been collaborating on biotoxin monitoring for more than 30 years. In 1980 John W. Hurst of DMR and Clarice M. Yentsch of Bigelow joined forces on a paper that set the stage for research around red tide in the Gulf of Maine. This new, more efficient way to analyze samples at BAS will aid resource management decisions at the state level, a continuation of this long-term collaboration to maximize the efficient use of state resources and safeguarding people’s health.

Equipment used in the analysis include high-pressure liquid chromatography coupled to a post-column oxidation system. During the busy summer season, BAS expects to process up to 40 samples per day that will enable the State to make closure decisions in a timely way.

Bigelow Laboratory for Ocean Sciences conducts research ranging from microbial oceanography to large-scale ocean processes that affect the global environment. Recognized as a leader in Maine’s emerging innovation economy, the Laboratory’s research, education, and technology transfer programs are spurring significant economic growth in the state.

The Department of Marine Resources conserves and develops marine and estuarine resources, conducts and sponsors scientific research, promotes and develops the Maine coastal fishing industries, advises and cooperate with local, state, and federal officials concerning activities in coastal waters, and implements, administers, and enforces the laws and regulations necessary for these purposes.