Wednesday 24 January 2018

Recent Outbreaks Case Studies for the Proposed Foreign Supplier Verification Program

Food Court over the past couple of weeks posted several entries outlining the various provisions of the proposed Foreign Supplier Verification Program. Analyzing the rules in the abstract can be difficult, especially given the depth and breadth of material in the proposed rule. Two recent food borne illness outbreaks linked to foreign suppliers may shed light on how the rule may play out.


Hep-A Outbreak Linked to Turkish Pomegranate Seeds

The US Centers for Disease Control (CDC) reports as of August 1, 158 people have been confirmed to have become ill from hepatitis A after eating ‘Townsend Farms Organic Antioxidant Blend.’ The CDC explains that by combining information gained from FDA’s traceback and traceforward investigations and the CDC’s epidemiological investigation, FDA and CDC determined the most likely cause for the hepatitis A virus appears to be a common shipment of pomegranate seeds from a company in Turkey, Goknur Foodstuffs Import Export Trading.

The FSVP may not have prevented the Hep A outbreak but would change the verification activites. At its core the FSVP would have required Townsend to identify potential hazards and verify the risks were properly controlled. This may have required an in-person auditing, but that may ultimately depend on how the rule is finalized. The berry mix was processed by Townsend Farms and sold in Costco and Harris Teeters. Various news outlets reports indicate both Costco and Townsend Farms already require an audit of suppliers by outside experts before selling a product in its stores. In this case the Turkish processing plant that handled the affected pomegranates was following the rules of an international code of safety called GMA-SAFE.  Under the rule it is possible for a third-party to audit the foreign supplier. GMA-SAFE is well known in the industry and will likely pass muster under the proposed rule for accrediting third party auditors. Assuming the GMA-SAFE auditors conducted an appropriate review within the past year the FSVP may have been satisfied. Third party audits are behind some big outbreaks – like the Jensen Farms cantaloupe outbreak, which raises questions about when the last audit was completed, if the audit was on-site in Turkey, and if Hep-A was identified as a potential risk. If Hep A was an identified risk the question becomes how often was a test run for the virus. While the FSVP may not have prevented the illnesses in this case, what the FSVP does change is the responsibility following an outbreak. The rule specifically sets standards to identify how a FSVP failed during an outbreak and to revise the FSVP following the outbreak. In the end while the FSVP may not have made a difference in the Hep-A case, it does demonstrate how a new layer of safety can be added following an outbreak. Never before has an importer been under a duty to respond to an outbreak in this way.


Cyclospora Outbreak Tied to Mexican Salad Mix

The latest food borne illness story involves an outbreak of stomach illnesses in Iowa and Nebraska has been linked to salad mix served at local Olive Garden and Red Lobster restaurants. The latest reports tentatively link the outbreak with a Mexican farm. The FDA announced it traced illnesses from the restaurants in Nebraska and Iowa to Taylor Farms de Mexico, the Mexican branch of Salinas, California based Taylor Farms. The company, which provides produce to the food service industry, said its facility located about 180 miles north of Mexico City in San Miguel de Allende is the only one of its 12 sites to be connected to the cases.

The FSVP again doesn’t change the result in the outbreak only the response afterwards. Taylor Farms CEO and Chairman Bruce Taylor told US News “All our tests have been negative and we have no evidence of cyclospora in our product.” Under a FSVP then its safe to assume cyclospora, a known bug of the tropics, was identified as a potential hazard. What the FSVP would require then is adequate verification activities to ensure the risk was contained. The list of activities could include lot by lot testing. Whether this was the type of testing conducted by Taylor Farms is unclear. As with the Hep A outbreak a re-evaluation of the risks would be required before shipments could continue into the US.


On the surface the FSVP seems ineffective. What we can’t expect it to do is stop all outbreaks. In the cases above the foreign suppliers were under some scrutiny from their US importers. This may not be the case for all foreign suppliers. The FSVP will make a difference by adding supplier verification activities where there are none. It will also have an impact by forcing suppliers to learn and adapt after outbreaks.

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