The document discusses the 2013 Fonterra botulism issue in New Zealand. In May 2012, Fonterra manufactured whey protein concentrate (WPC80) that was later found to contain Clostridium botulinum. The contaminated batches were supplied to customers in 6 countries. Testing in March-June 2013 found Clostridial bacteria, and in July 2013 C. botulinum was confirmed. Fonterra notified authorities and recalled products. The crisis developed from May 2012 to September 2013 as more details emerged. The incident highlighted issues with Fonterra's processes and had significant financial and reputational costs. It demonstrated the importance of rigorous testing and response procedures to prevent food safety crises.

1. The Fonterra Issue & Botulinum Threat
Presented By:
Duangtip Theerasin
Agnescia Clarissa Sera
Monica Pradhan

2. Lets break the ice by thinking…..
What is the cost
of an unsafe
FOOD ???

3. 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….

4. 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

5. 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 Clostridial
bacteria, 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

6. 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)

7. 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 Spierings
and Primary Industries Minister, Nathan
Guy
• exchanged a frank information over the
mistake that happened in May 2012

8. 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

9. 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

11. 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

12. WPC 80 Rework Process

13. What they have improved after the incidence

14. 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

15. 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

16. 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)

17. Primary hosts and gene location
Serotype 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

18. Outbreaks in Australia
 In Australia between 1942 and 1984 there were 5 outbreaks of botulism,
affecting 53 people with 9 fatalities. Foods implicated include canned
vegetables (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).

19. 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

20. 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

21. Symptoms (12-36 hours after consumption)
Nausea, diarrhoea
abdominal pain, vomiting
muscle paralysis
double vision, double eyelids
trouble speaking, swallowing or
breathing

23. 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

24. 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).

25. 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.

26. Muscle Paralysis
Neurotoxin
Muscle cell
Ach receptor
Nerve cell(Neuron)
Axon Acetylcholine-Ach
No muscle contraction …(also used in Botox..).

27. 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.

29. Global recognition of infant botulism according to country:
1976 – 2006
www.pediatrics.org

30. 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.)

31. A Case study
An incident of
Infant Botulism
in UK (Yr:2001)
Brett et al.(2005).
In Journal of Medical Microbiology (UK).

32. 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.

33. ❖ 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:

34. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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)

41. 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.

42. So what do you now think
is the cost of
UNSAFE FOOD?
The loss cannot be put in number
(We are still discussing Fonterra!)

43. 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

44. 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?

45. 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

46.  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

47. From Purity to Safety……..