The laboratories at the centre of the Fonterra contamination scare were not accredited to carry out tests for botulism, it has been revealed.
Fonterra asked AgResearch to test whey samples for the presence of the clostridium botulinum toxin. AgResearch returned a positive test.
Going on that information, Fonterra issued a statement sparking global recalls of its product and a firestorm of panic by customers and criticism of the dairy giant. But the organisation in charge of accreditation of laboratories says the crown research laboratories were never qualified to carry out the tests. No labs in New Zealand are accredited.
Fonterra’s decision to use a non-accredited lab for the critical tests has been criticised by agribusiness professor Jacqueline Rowarth.
»They should always go for the [lab with] accreditation,» the Waikato University professor said. She said the whey samples should have been sent straight to the national regulator Ministry for Primary Industries.
When MPI was finally notified by Fonterra, it sent samples to four overseas labs, all accredited, and had results back in three and a half weeks.
Those results from American Food and Drug Administration-associated labs confirmed the contamination in the whey was a harmless strain of clostridium sporogenes.
Fonterra said it went to AgResearch because it is ‘one of only two’ research facilities in New Zealand capable of carrying out the test.
AgResearch acknowledges it is not accredited, but said it has the necessary experience and facilities to test for botulism – the tests involve killing mice.
But Dr Llewellyn Richards from International Accreditation NZ, which accredits labs, said without accreditation there was no certainty of accurate results from a laboratory carrying out tests.
Accreditation »gives an assurance of their competence for the test they are carrying out,» the IANZ chief executive said.
Without it, labs could claim »whatever they like», he said. »There’s no proof of their competence.»
Accredited labs have the approrpriate test equipment, scientist competency, and test results were routinely independently checked, Dr Richards said.
Labs can only gain accreditation for tests they carry out routinely, and because the botulism-causing bacteria is so rare, labs hardly ever came across it.
It was difficult for labs to aquire the botulism bacteria to work with because the USA treated the toxin as a biological weapon and had concerns about terrorists accessing it. It was the most potent toxin known to man and is therefore highly regulated, Dr Richards said.
Special equipment was needed to work with it, Massey University food microbiology specialist Steve Flint said. He said AgResearch had laboratories with research capability for the toxin, but this was limited.
AgResearch said it agreed to carry out the botulism tests for Fonterra in its capacity as a researcher, not as an IANZ accredited lab. It said when it advised Fonterra of the positive result, it told Fonterra to also seek further testing.
However, Fotnerra said it had no choice at that time but to go public that there was a potential botulism contamination.
As a rule, labs should always make it clear when they are not qualified for a test, Massey Uni microbiologist Dr Jon Palmer said. »We do testing and say we’re not accredited so people are aware, and we will recommend someone who is.»
This week Fonterra said that, as a response to the false botulism scare, it was making changes to the way it operated including establishing a new role of group director of food safety and quality who will report directly to the chief executive, and an internal food safety and quality hotline for staff and contractors.
Other actions include a review of traceability systems in Fonterra’s global businesses, and specialised audits of global manufacturing plants and product quality standards.
Professor Rowarth said Fonterra should have quarantined the whey batch as soon as it became aware there was a potential contamination and should never have released it to customers while it waited for tests – so a recall would not have been needed. Fonterra said it became aware in May 2012 there was some potential contamination with a piece of plastic in the batch of whey – it then reprocessed the batch, but did so with equipment that had a dirty pipe. The pipe is believed to have lead to the Clostridium contamination.
It was not until March this year that the Clostridium contamination was picked up, in Fonterra’s Darnum Park plant in Australia.
Fonterra then began a process of testing to see what type of Clostridium it was.
Rowarth said back in May 2012 the batch should have been sidelined as stock feed and not released for human consumption.
Source: Stuff