Fonterra and the C. Botulinum Scare

It’s a CEO’s worst nightmare. You’re 11,000 miles away from the office when your cellphone rings late at night. You see that it’s work calling. “Oh, oh,” you exclaim. “It must be bad news. They wouldn’t disturb me otherwise.”

Theo Spierings lived this bad dream as clocks struck midnight in his native Netherlands on  Thursday, August 1, 2013. The chief executive officer of Fonterra Cooperative Group Ltd. was back home for a relative’s funeral. He receives the fateful phone call from one of the company’s senior managers at headquarters in Auckland, New Zealand, where it’s 11:00 p.m.

It was bad news. Laboratory tests had come back likely positive for Clostridium botulinum in some Fonterra whey protein concentrate known as WPC80. Thus was sparked a globally publicized multi-million dollar international recall.

“I began my career as a food technologist and although I knew botulism is hardly ever found in dairy, I knew we had to act,” Spierings says. “Food safety must always be our number one priority. So the first thing I did was ask what products had been affected, which customers and which geographies. We then immediately informed our board of directors and the New Zealand Ministry of Primary Industries (MPI), which regulates food safety, and went public with our precautionary recall.”

On Friday, August 2, Fonterra initiated a precautionary recall of 38 tons of its WPC80, advising the eight customers, including three food companies, two beverage companies, and three animal feed producers in Australia, China, Malaysia, New Zealand, Saudi Arabia, Thailand, and Vietnam, that had received the potentially affected ingredient.

Turn Back the Clock

The Fonterra WPC80 recall story actually begins in May 2012. On the last three days of WPC80 manufacture for the 2011/2012 New Zealand dairy season, the Fonterra whey manufacturing facility in Hautapu, New Zealand produced three batches of WPC80 out of a rework process. This manufacture occurred from May 15 to 18, 2012, with the product reprocessed and packed on May 17, 18, and 22.

The reprocessed WPC80 passed the standard, routine testing for compositional and food safety/pathogen requirements for whey powder.

Fonterra first identified a quality issue with this particular WPC80 in March 2013. At that time routine testing conducted at Fonterra’s Darnum site in Australia identified high Clostridia levels in finished product made for a customer.

Microbiology Testing

Immediately after the high Clostridia levels were detected at its Darnum plant, Fonterra began an extensive process of microbiological testing at its research center in Palmerston North, New Zealand, to determine what type of Clostridium it was.

On May 8, 2013, a MALDI-TOF test (Matrix Assisted Laser Desorption/Ionization-Time of Flight), a sophisticated mass spectrometry technique, conducted at the research center indicated that the Clostridia were most likely Clostridium sporogenes, which isn’t a food safety hazard but at high levels can cause food to spoil, but the findings were not definitive. The research center’s further testing was unable to rule out the presence of C. botulinum.

The definitive test for C. botulinum, a mouse bioassay, could only be conducted at two recognized testing facilities in New Zealand.

So on June 26, 2013, Fonterra commissioned AgResearch Limited, a New Zealand government-owned Crown Research Institute, to conduct a mouse bioassay test to confirm whether the identified strain was C. sporogenes or C. botulinum.

On July 31, 2013 Fonterra received AgResearch’s test results, which identified the “potential presence” of C. botulinum in bacteria sourced from product containing the WPC80. The tests showed that this risk was minute, but it was still a risk.

Thus, the midnight call to Spierings while he was in the Netherlands.

Tests in the U.S.

Subsequent to the precautionary recall, MPI commissioned WPC80 testing at two U.S. labs that are accredited for C. botulinum testing, the Centers for Disease Control and Prevention, Atlanta, Ga. and the National Veterinary Services Laboratory, Ames, Iowa.