Fonterra and the C. Botulinum Scare

While the root cause of the contamination was an item of nonstandard equipment used in reprocessing the WPC80, a computer systems upgrade, as well as lapses in escalation and communication to higher levels of management also played a part in contributing to the event, Leyland points out.

“Actions have been taken to immediately address these issues,” she says. “Specifically, in relation to the reprocessing of the WPC80 and use of nonstandard equipment, we have clarified our reprocessing procedures with our teams and these have also been embedded into our HACCP plans.

“In New Zealand each year Fonterra produces 2.3 million tons of high quality dairy products from 17 billion liters of milk,” Leyland says. “To achieve this we have world-class manufacturing facilities, quality systems, and robust testing regimes in place. This event stress-tested all of them. Overall our systems worked well, while some aspects showed room for further improvement.”

To that end, the WPC80 event definitely fostered learnings, Leyland relates, and as a result, several areas have been identified where the cooperative needs to improve. “We are now well underway in implementing these improvements and we’re confident that the associated action plan will make Fonterra stronger,” Leyland emphasizes.

Government Reviews

The MPI and the New Zealand government are conducting WPC80 recall reviews.

The Government Inquiry into the whey protein concentrate contamination incident has three parts that have been divided into two tranches. Part A is an inquiry into how the potentially contaminated whey protein concentrate entered New Zealand and international markets, and how this was subsequently addressed. Parts B and C involve inquiries into regulatory and best practice requirements, and comparison of Part B’s findings to similar matters in other comparable jurisdictions, respectively.

The government has said that the inquiry will prepare an interim report on Parts B and C within three months of the September 12, 2013 publication of notice in the New Zealand Gazette, the official newspaper of the Government of New Zealand. The final full report will be produced after the MPI compliance investigation and any subsequent court proceedings have reached a stage where they cannot be prejudiced by the inquiry’s processes.

All recalled Fonterra WPC80 was accounted for or contained by the time that MPI released its Tracing and Verification Report on August 28. That same day, MPI acting director-general Scott Gallacher issued a statement confirming that, based on testing and additional information, the identified batches of WPC80 and all recalled infant formula products that contained this WPC80 were not contaminated with C. botulinum and posed no risks to consumers of contracting botulism.

To date, there have been no confirmed reports of illness as a result of any person or animal consuming this recalled WPC80 or any products that contained it. Moreover, there never was actually a botulism risk associated with the WPC80 to begin with.

MPI is undertaking a compliance investigation into the WPC80 incident that will determine whether regulatory requirements under New Zealand’s Food Act 1981 and Animal Products Act 1999 were met by all parties involved, or whether any parties may have committed any breaches or offences.

“This investigation is still underway,” Gallacher says. “As such, it’s too early to provide a timeframe for when the investigation will be completed, or when a final report of findings will be available.”

In-House Recommendations

Based on comprehensive findings, and to achieve the intended outcomes, the Fonterra Operational Review recommended 20 actions which cover four key elements of the cooperative’s business, namely people, products, systems, and response. (See sidebar below to view Fonterra’s recommendations.)

“The Operational Review concluded that Fonterra’s quality and care systems in our manufacturing and testing are robust, and underpin our reputation for leadership in the global dairy trade,” Leyland says “Transparency of information, internally and externally–despite the lapses in information sharing and escalation noted in the review’s findings–and commitment to public safety, were reflected throughout this event. Notwithstanding the shortcomings identified by the review, our staff, on most occasions, acted conscientiously on new information, and generally sought to do the right thing.