The Fonterra Issue & Botulinum Threat

Presented By:Duangtip Theerasin Agnescia Clarissa SeraMonica Pradhan

Lets break the ice by thinking…..

What is the cost of an unsafe

FOOD ???

Welcome everyone!!An insight into the challenges of Food Safety business:

▪ Lets critically evaluate the seriousness of an issue related to a baby food

▪ Causes that could be have been prevented

▪ Issues that was meant to be handled more effectively

▪ Issues that raised concern worldwide

▪ Issues that defamed Fonterra

▪ Issues that escalated the concern of consumers….

Fonterra Crisis

▪ Clostridium botulinum was found in whey protein concentrate (WPC80) on the 31st

of July 2013

▪ Manufactured in May 2012, 3 batches (38 tonnes) by Fonterra, Hautapu site, Waikato NZ

▪ Supplied to 8 customers in 6 countries

▪ Whey protein concentrate is one of raw materials for producing infant formula, sports drinks, yoghurt and animal feeds

Development of the crisis from May 2012- September 2013

March 2013

• Used WPC 80 (manufactured May 2012) in value added formulations

• At Waitoa, NZ and Darnum, Australia

March-June 2013

• Fonterra Research Centre conducted sample test

• Presence of Clostridialbacteria, likely to be sporogenes

31st July,2013

• AgResearch using mouse bioassay

• AgResearch confirmed the presence of C. botulinum in the samples sent by Fonterra

• Confirmations of C. botulinum presence in WPC 80 were made from Waitoa and Darnum labs

Development of the crisis from May 2012- September 2013

31st July 2013

• Fonterra contacted 8 customers

• Fonterra notified appropriate authorities

• Recalled all products from market place

2nd August 2013

• Fonterra advised the Ministry for Primary Industries of “product non-conformance”

• Recall of products was made

3rd August 2013

• Fonterra released a media about contamination of C. botulinum in WPC 80 (3 batches produced in May 2012)

Development of the crisis from May 2012- September 2013

4th -5th August 2013

• Fonterra named customers that it three batches WPC were sold to;

• Danone , Vitaco, Fonterra animal feed subsidiary NZ agbiz, Maxum, Wahaha, Coca-cola

8th – 9th August 2013

• John Wilson Fonterra Chairman said the incident was the worst nightmare for a food business

• Fonterra Chief executive, Theo Spieringsand Primary Industries Minister, Nathan Guy

• exchanged a frank information over the mistake that happened in May 2012

Development of the crisis from May 2012- September 2013

12th August 2013

• The Ministry for Primary Industries (MPI) launched an investigation of Fonterra’s contaminated WPC80

22nd August 2013

• Fonterra announced the new extended testing procedure that will provide additional quality assurance for resolving the issue

28th August 2013

• MPI confirmed that bacteria found in WPC 80 manufactured by Fonterra in May 2012 was not linked to botulism

• It was found to be Clostridium sporogenes

• Results were from 2 labs in USA and 2 labs in NZ

Development of the crisis from May 2012- September 2013

5th September 2013

• AgResearch, NZ said to the media that it had confirmed the test Clostridium in WPC 80 samples from Hautapu had potentially detected botulinum and recommended that further testing should be carried out

• Fonterra did not act wisely with the recent result

Video: http://www.stuff.co.nz/business/farming/dairy/9097910/Contaminated-whey-protein-traced

https://www.youtube.com/watch?v=V6pfSqJtfSE

Fonterra Manufacturing Trace Back

▪ Found out that WPC80 three batches were reprocessed due to concern of foreign matter contamination (small piece of plastic)

▪ Product were filtered the process used was non- standard and possible of contamination may from a transfer pipe

▪ Cleaning was done before but noted that this pipe was not used in standard process as it had been decommissioned

WPC 80 Rework Process

What they have improved after the incidence

Company’s economic and reputation from the incidence

Fonterra lost more than $60 million within hours of the announcement of potential contamination

Danone (Paris, France) one of the customers who received false alarm of C. botulinum contamination seeking $270 million from Fonterra for compensation of their product recall.

SMEs infant formula manufacturer in NZ were suffered from this false alarm they lost 2 million dollars a year from this incidence, until the Asian market had regained confidence in NZ product

Botulism▪ serious paralytic illness caused by a nerve toxin produced by the bacterium

Clostridium botulinum

▪ First described by Emile Pierre Marie van Ermengem in the 19th century on a report on “sausage poisoning”

▪ Types:

food-borne botulism wound botulism infant botulism, and adult intestinal colonization

botulism

Clostridium botulinum

▪ Anaerob, obtain energy by fermentation

▪ Gram positive-spore-forming rods

▪ Habitats : soils, intestinal tracts of animals

▪ Incubation : several days to 1-2 weeks

▪ Produces botulinum neurotoxins (serotypes A-

G)

▪ Toxin is active through oral route, block nerve

function

▪ Toxin is inactived by heat and alkali but is stable

under acidic conditions

▪ The toxin is not produced in food containing

sufficient salt or acid

Clostridium botulinum (www.foodsafety.asu.au)

Primary hosts and gene locationSerotype Suspectible Species Location of neurotoxin gene

A Humans, horses Chromosome, large plasmids in some strains

B Humans, horses, swine, primates Chromosome, large plasmids in some strains

C Birds, horses, cattle, minks, foxes, dogs, turtles Pseudolysogenic bacteriophage, plasmids

D Cattle Pseudolysogenic bacteriophage, plasmids

E Fish, waterfowl Chromosome, large plasmids in some strains

F Humans (rare) Chromosome, large plasmids in some strains

G None known Large plasmids

Source : Johnson, 2013

Outbreaks in Australia

In Australia between 1942 and 1984 there were 5 outbreaks of botulism,affecting 53 people with 9 fatalities. Foods implicated include cannedvegetables (mushrooms and asparagus) and canned tuna.

Cases reported in Australia for food borne botulism - 2 cases (Yr 1997 – 2007) Yr 1999 : 1 no.

Yr 2007 : 1 no.

Cases reported in Australia for non-food borne botulism- 9 cases

(Yr 2002 – 2011)

Queensland Health Guidelines for Public Health Units for managing botulism (July, 2014).

C. botulinum is a 'prescribed contaminant' under the Food Act 2006 and Food Regulation 2006.

This means that if it is identified in food intended to be sold it must be notified orally immediately to the chief executive of Queensland Health and reported in writing (using the approved form) within 24 hours by the person who has identified the contaminant and/or the person who was intending to sell the food

Source of trouble :

Raw and minimally processed low-acid foods, mainly associated with improperly canned food

food formulations with pH and aw within the growth range of C. botulinum, inadequate levels of antimicrobial food ingredients, reduced oxygen environment, lack of competitive microflora, inadequate thermal processing, recontamination of commercially sterile products because of poor seals or after opening, and inadequate control of storage temperature-time

can result from the consumption of food containing as little as 30–100 ng of preformed BoNT

Symptoms (12-36 hours after consumption)

Nausea, diarrhoea

abdominal pain, vomiting

muscle paralysis

double vision, double eyelids

trouble speaking, swallowing or breathing

Prevention of Foodborne botulism(Proper food processing, preservation, and temperature control)

Spore destruction Processing:

◦ Thermal processing 121 °C (retort processing, conventional canning),

◦ pH >4.6 and water activity >0.85

◦ Pressure-assisted thermal sterilization (690MPa, 110 °C for 4 min)

◦ ultra-high temperatures (140 °C)

◦ Use combination of appropriate temperature, pH, aW, antimicrobial agents, organic acid salt (acetate, propionate, sodium nitrite)

Storage: refrigeration t < 10 °C

Infant Botulism

❖ Intestinal colonization of Cl.botulinum in infant (Infant Botulism)

❖ First recognized in 1976 & typically affects children under one year of age.

❖ Sources of Spores: Honey, infant milk formula, and dust spores, medicinal herbs and teas - in some countries like Argentina.

❖ Minimum infective dose of C. botulinum spores required to cause infant botulism has been estimated to be as low as 10–100 spores

❖ The most common clinical form of botulism in the United States (70 - 100 cases recognized annually).

Infant Botulism

❖Occurs due to:

• Ingestion of soil dwelling spores of C.botulinum which germinate, colonize the intestine, germinate and multiply in the GI tract, allowing the release of botulinum neurotoxin (BoNT) into the blood stream

• Ingestion of preformed toxin. BoNT then irreversibly binds with the cell membrane within the neuromuscular system.

Muscle Paralysis

Neurotoxin

Muscle cell

Ach receptor

Nerve cell(Neuron)

Axon Acetylcholine-Ach

No muscle contraction …(also used in Botox..).

Symptoms and Treatment:

Symptoms:

Occurs within 12-36 hours

Constipation, lethargy, weak cry Floppy baby, poor muscle tone, Paralysis, weakness, impaired Respiration.

Treatment:

Antitoxin: equine

A specific treatment for infant botulism, botulism immunoglobulin (BIG-IV or BabyBIG®), was developed in 2003.

Global recognition of infant botulism according to country: 1976 – 2006

www.pediatrics.org

Symptoms and Treatment:

Symptoms:

➢ Occurs within 12-36 hours

➢ Constipation, lethargy, weak cry Floppy baby, poor muscle tone, Paralysis, weakness, impaired Respiration..

Treatment:

➢ Antitoxin: equine

➢ A specific treatment for infant botulism, botulism immunoglobulin (BIG-IV or BabyBIG®), was developed in 2003.

➢ Botulinum Antitoxin is for Emergency Use.

(Only for administration to individuals on the slightest suspicion of botulism.)

A Case study

An incident of

Infant Botulism

in UK (Yr:2001)

Brett et al.(2005).

In Journal of Medical Microbiology (UK).

The Case:

❖ Hospital admission of a 5 month old formula fed infant on June 2001.

❖ Diagnosed Symptoms-constipation and progressive neurological deterioration

❖ Clinical diagnosis: C.botulinum

❖ C botulinum type B and type B botulinum neurotoxin detected In rectal was-out and faeces

❖ Possible Cause: consumption of contaminated infant formula powder❖Manufactured in 1998 ❖Recalled in August, 2001❖Shelf life till Nov, 2001.

❖ Impact: Gradual improvement though developmental delay in cognitive elements persisted even three years later

❖ Possibility of the Source of Contamination

▪ Low possibility of Cross contamination from home, environment or labs

▪ Some of the C. botulinum type B isolates from the opened infant formula yielded patterns

▪ Some of which were same as the clinical isolates.

▪ Contamination of similar strain in similar level was found in Opened and unopened containers of the same batch.

Hence study is strongly indicative of Contamination during factory processing

The Case:

Importance of the Case Study

▪ The study estimated the optimum sampling size for 95% chance of detection and related this to the underreporting of the issues in the past.

▪ Links the possible source of contamination to the manufacturing process thus indicating the possibility of a wide scale of impact of C.botulinum contamination on infant health.

Preventing botulinum:

At a household level:

❖ Use of Wild honey (potential source of C. botulinum spores) to be controlled to infants 12 months of age or less.

❖ Breastfeeding may slow the onset of illness if it develops.

❖ Avoid exposure to potentially contaminated soil or dust.

❖ Boiling canned foods for 10 minutes before serving them.

❖ Educating people concerned about the importance of adequate processing and storage of food.

C. botulinum may or may not cause container lids to bulge or the contents to smell off.

Preventing Botulinum

On an industrial level:

❖ Effective implementation of PRP’s like GMP and GHP in the food production site.

❖ Stringent Plant Sanitation and Personal Hygiene

❖ Regular Preventive maintenance and timely Break down maintenance

❖ Strict adherence to FSANZ Code of conduct and product specifications

❖ Effective implementation of applicable Food Safety Systems(FSMS ISO 22000:2005),HACCP etc.

Conclusion

❖ The impact of food intoxication due to botulinum is severe and can be life threatening.

❖ The spores of Clostridia spp. are commonly found and may germinate to bacilli to produce toxin.

❖ Consumers now need to be more conscious of cross contaminations while handling food at home.

❖ A stringent preventive plan for food safety should be adopted and implemented by Food manufacturing and serving industries.

Conclusion

Implications of Fonterra case:

❖ Loss in trade:

▪ Australia, China, Malaysia, New Zealand, Saudi Arabia, Thailand, and Vietnam were affected by the recall.

❖ Financial implications

▪ Fonterra was fined NZ$300,000 in April, 2014 regarding inadequate Risk-management program and delayed notification of problems.

▪ Loss in compensation: (French food company Danone, sought about €300 million in damage).

❖ Conflict in Reporting: Clostridium botulinum contamination had been initially declared. Contamination of Clostridium sporogenes was later testified.

Conclusion

On Fonterra's Precautionary Recall

False Alarm is good news but false positive must be investigated..

“The quality and integrity of diagnostic testing is already

significant component of ministerial inquiry. It is the Food &

Grocery Council’s sincere hope that this economic

disaster for New Zealand is not

based on inadequate science”New Zealand Food Grocery Council Chief executive and

Food Navigator-Asia Commentator: Katherine Roch

(on 29.08.2013)

Conclusion

❖ The importance of confirmed product testing before dispatch is to be a priority.

❖ Use of accredidated laboratory and validated protocols for testing purpose is extremely important.

❖ The Recall was a good illustration of Corporate Social Responsibility. But by the time of recall, 38 tons was already mixed in 1,000 tons of consumer products world wide.

❖ The Fonterra Issue helped to realize that noncompliance can occur anytime in any system.

So what do you now thinkis the cost of

UNSAFE FOOD?

The loss cannot be put in number

(We are still discussing Fonterra!)

Warren Buffet famously once warned:

“It takes 20 years to build a reputation and five minutes to ruin it. If you think about that, you will do

things differently.”

Thank you

So Lets brain storm for a change----

❖How is the food industry and consumers affected by Food Recall?

❖How often do you hear of recall in your country?

References

▪ Glass, K & Marshall, K 2012, Foodborne Infections and Intoxications, Elsevier Inc,

▪ Brett M.M, .McLauchlin, J, Harris A, O’Brien S, Black,N,. Forsyth, R.J ,Roberts,D and Bolton, J.F(2005): A case of infant botulism with a possible link to infant formula milk powder: evidence for the presence of more than one strain of Clostridium botulinum in clinical specimens and food. Journal of Medical Microbiology (2005), 54, 769–776.

▪ http://www.mla.com.au/off-farm/Food-safety/Food-safety-for-consumers/The-bug-bible/Clostridium-botulinum

▪ http://www.health.qld.gov.au/cdcg/index/botulism.asp

▪ http://en.wikipedia.org/wiki/2013_Fonterra_recall

▪ http://www.abc.net.au/news/2013-08-28/an-fonterra-update/4918964

http://www.bloomberg.com/news/articles/2013-08-05/botulism-scare-halts-fonterra-milk-powder-sales-to-china-russia

http://www.foxnews.com/health/2013/08/03/new-zealand-botulism-scare-triggers-global-recall/

http://www.foxnews.com/health/2013/08/03/new-zealand-botulism-scare-triggers-global-recall/

http://www.who.int/mediacentre/factsheets/fs270/en/

http://www.slideshare.net/doctorrao/c-botulinum-17072998?related=1

References

From Purity to Safety……..