FDA Denies CSPI Petition for Vibrio Performance Standard in Shellfish
The U.S. Food and Drug Administration (FDA) has denied a February 9, 2012, petition filed by the Center for Science in the Public Interest (CSPI) that requested “a performance standard of non-detectable as determined by the best available method of detection for Vibrio vulnificus in molluscan shellfish intended for raw or processed raw consumption.”
Citing V. vulnificus as “the leading cause of seafood-associated deaths in the United States,” the petition notes that FDA already enforces a zero tolerance standard for V. vulnificus in ready-to-eat fish and a non-detectable standard of less than 30 most probable numbers per gram (MPN/g) for post-harvest processed shellfish. According to CSPI, the Food Safety Modernization Act directs the agency to set performance standards for significant foodborne contaminants.
In rejecting the petition, FDA notes that other strategies—including state adherence to and federal oversight of control measures designed to manage V. vulnificus risk—have effectively reduced oyster-associated V. vulnificus illnesses since 2013. In particular, the agency points to the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish (NSSP Guide) adopted by FDA and the Interstate Shellfish Sanitation Conference (ISSC). Controls enacted under the NSSP Guide set “a risk-per-serving approach to be achieved through implementation of stringent post-harvest time-to-temperature controls,” among other measures. In addition, ISSC has focused on educating the immunocompromised population about the risks associated with the consumption of raw or undercooked shellfish; FDA has partnered with the National Oceanic and Atmospheric Administration to refine V. vulnificus risk forecasting; and a Vibrio Assessment Review Board provides research and technical assistance to states and industry.
“In sum, FDA continues to work on innovate ways to further improve Vibrio management,” writes FDA Director for the Office of Food Safety Nega Beru. “The risk assessments discussed… will help states craft Vibrio management plans tailored to the specific risk factors in their regions; such as whether illnesses arise early or late in the growing season. Understanding populations and predictive modeling will allow states to use resources more wisely and further reduce illnesses by minimizing post-harvest Vibrio growth.”
Issue 626
