FERN's Impact on Recent Outbreaks and Public Health Events:
PAHs in seafood (2010):
The Deepwater Horizon Oil Spill was caused by an explosion on a drilling rig on April 20, 2010 that released several million barrels of crude oil into the Gulf of Mexico until the wellhead was capped on July 15, 2010. The oil from the Deepwater Horizon well contaminated a large number of Gulf state fisheries in Louisiana, Alabama, Mississippi, and Florida which resulted in an almost total shutdown of the industry. NOAA, FDA and State governments all became involved in closing of state and federal waters to commercial fishing. The closures were based on the public health threat from contamination of seafood by polyaromatic hydrocarbons (PAHs), the principal toxicologic concern. To address this threat, a detailed state waters reopening protocol was implemented involving an extensive chemistry testing program. This protocol outlined specific levels of concern for each PAH that the labs were tasked to measure. FERN laboratories (including FDA Office of Regulatory Affairs Field Laboratories and FERN Cooperative Agreement Laboratories) were used to analyze these reopening samples. Two methods were used in the chemistry testing portion of the protocol, a method developed by NOAA and a PAH screening method developed by the FDA. FERN Cooperative Agreement Program laboratories were critical to the development and implementation of this PAH screening procedure. Without the analyses performed by FERN laboratories and the development of a rapid screening method, the safe and rapid reopening of the Gulf state fisheries would not have been possible.
The FERN was activated in May, 2010. Immediately after, the FERN began to assess network capabilities and capacities for the NOAA method, and worked with selected FERN Cooperative Agreement Program laboratories to develop capability for this methodology in those laboratories. Additionally, the FERN Storeroom ordered and stocked standards and reagents required for performing the NOAA method. Reagent requests were filled on a prioritized basis, with first priority going to Gulf State laboratories and laboratories conducting FERN directed testing. Over the course of the FERN Activation, over 300 finfish, crab, oyster and shrimp samples from Florida, Alabama, Mississippi and Louisiana were analyzed for PAHs using the LC-MS alternative screening method as part of the state reopening process. Approximately 20% of those samples received parallel analysis using the NOAA method. In addition to the reopening samples, approximately 100 state baseline samples were analyzed using the NOAA method. The FERN was deactivated for this incident in November, 2010, but continues to support the PAH testing efforts of FERN laboratories in the Gulf.
Salmonella Typhimurium in peanut butter (2009):
Fall 2008 and Winter 2009 brought an outbreak of 714 cases of Salmonella Typhimurium infection in 46 states linked to consumption of products containing peanut butter produced by the Peanut Corporation of America (PCA) Blakely, GA plant. Over 2800 products were identified that contained peanut butter produced by this plant. FERN laboratories were not officially activated, but there were strong contributions to the investigation from FERN laboratories in MN, MI, OH, and CT. FERN storeroom reagents were made available as well as technical guidance, methods, and molecular fingerprinting (PFGE) support.
Salmonella Saintpaul in peppers (2008):
During the spring and summer of 2008, the 2nd largest outbreak of Salmonella Saintpaul ever reported in the United States was identified by PulseNet (>1400 cases) in 43 states, DC, and Canada. Initial epidemiologic reports indicated tomatoes as a potential common food source, but further investigation by the FERN and other public health agencies and laboratories led to the identification of an indistinguishable Saintpaul isolate from a jalapeno pepper which was traced back through a distribution center in Texas to a grower in Mexico. The FERN was activated and 12 FERN microbiology laboratories analyzed pepper, cilantro and basil samples collected through state and FDA coordinated efforts. FERN testing augmented and complemented concurrent FDA ORA testing efforts. All told, FDA tested a total of 1618 samples, and found 75 positives (39 unique Salmonella serotypes), and FERN tested a total of 290 samples, and found 13 positives (6 unique Salmonella serotypes).
Melamine in Infant Formula and Milk Based Products (2008):
In 2008, melamine resurfaced as an adulterant added to infant formula and other food products (e.g. chocolate) linked to producers in China, and the FERN was activated. New HPLC-MS/MS methods were developed and validated by FDA for infant formula and other dairy products, and LC-MS methods with increased sensitivity over the melamine GC-MS method were developed and implemented as well. These methods were used by USDA, FDA, FERN, and the states in the analysis of milk based products for melamine. USDA and FDA have analyzed thousands of samples since 2007 for melamine and its analogs, and FERN chemistry laboratories assisted FDA in the CFSAN Melamine Import Assignment for the analysis of milk and soy protein based samples. FERN laboratories analyzed a total 340 samples, found 14 detections for melamine and/or analogs, and were a key factor in clearing an FDA sample backlog, which arose due to very high collection rates.
Melamine in Pet Food (2007):
In the spring of 2007, there were reports of companion animal illness and death linked to pet foods with ingredients imported from China, and melamine and cyanuric acid were identified as the hazardous adulterants. As wheat gluten (a commonly adulterated ingredient), was found to be in other animal feed products, the contamination issue spread. The FERN was activated, and 8 FERN Chemistry Cooperative Agreement Program Laboratories participated in the FDA Protein Surveillance Assignment, analyzing over 200 samples. With federal and state assistance, the FDA Forensic Chemistry Center developed a GC-MS screening method for melamine and its analogs that was used in this Surveillance Assignment. There was also a collaborative effort among states, USDA and FDA to develop HPLC-MS/MS methods for the analysis of melamine and cyanuric acid in animal tissue (fish and pork, e.g.)
E. coli O157:H7 in Spinach Outbreak (2006):
In August 2006, public health laboratories in the US identified 199 cases of E. coli O157:H7 in 26 states linked to the consumption of fresh spinach. Overall 51% of the cases were hospitalized and 16% had kidney failure. The FERN was activated during this outbreak and provided access to reagents through the FERN storeroom, technical guidance, screening and culture methods, monitoring to determine the need for surge capacity, and a harmonized FERN/LRN/CDC method was quickly reviewed and published electronically on the eLEXNET system for use in FERN laboratories.