🏒 Government Inquiry into Whey Protein Concentrate Contamination Incident

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The establishment date of the Government Inquiry into the Whey Protein Concentrate Contamination Incident is based on the date terms of reference were issued, 10 September 2013. The disestablishment date of the Inquiry is based on the date the second and final part of the Inquiry’s report was presented to the Ministers for Primary Industries and Food Safety, 28 November 2014.

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  1. Government Inquiry into the Whey Protein Concentrate Contamination Incident (Department of Internal Affairs website), http://www.dia.govt.nz/Government-Inquiry-into-Whey-Protein-Concentrate-Contamination-incident (accessed 28 December 2014).
  2. New Zealand Gazette website, https://www.gazette.govt.nz/ (accessed 28 December 2014).
  3. The Official Website of the New Zealand Government, http://www.beehive.govt.nz/ (accessed 28 December 2014).
  4. New Zealand Legislation website (Parliamentary Counsel Office), http://www.legislation.govt.nz (accessed 28 December 2014).
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Establishment

The Government Inquiry into the Whey Protein Concentrate Contamination Incident was established on 10 September 2013 by the Minister for Primary Industries and the Minister for Food Safety pursuant to section 6(3) of the Inquires Act 2013.

The following persons were appointed to and constituted the Inquiry:

  • Miriam Rose Dean, CNZM QC (chairperson);
  • Dr. Anne Marie Astin, PSM (member); and
  • Anthony John Nowell, CNZM (member).1

Professor Alan Reilly, Chief Executive of the Food Safety Authority of Ireland (and Adjunct Associate Professor, University College, Dublin) was appointed to independently peer reviewer of the Inquiry's report.

The Inquiry began considering evidence from 12 September 2013.

The Department of Internal Affairs was responsible for administrative matters relating to the Inquiry.

The establishment of the Inquiry was in response to a potential food contamination incident.  In early August 2013, the biggest food safety scare in New Zealand’s history followed a suspicion that infant formula and possibly other products, too, were infected with botulism-causing Clostridium botulinum. The source of the suspected contamination was whey protein concentrate made by dairy co-operative Fonterra, the output of which constituted nearly 90 per cent of the country’s dairy production at the time.2

Three weeks later, two United States laboratories confirmed the whey protein concentrate had never posed any food safety risk. But that news came too late to prevent widespread concern among parents and caregivers, as well as significant economic harm and damage to reputations. The impact was particularly significant in relation to infant formula, an area of growing importance for New Zealand, with a then estimated $1 billion worth of exports per year.3

Background to the Inquiry4

In February 2012, Fonterra suspected that three batches of whey protein concentrate (WPC80) contained small pieces of unrecovered plastic from a torch sucked into processing equipment.

In May 2012, Fonterra reprocessed - or reworked, to use the industry term - the affected whey protein concentrate into three finished batches totalling 37.8 metric tonnes. The reworking involved some improvisation, including use of a transfer pipe and hoses that were not standard equipment.

Between July 2012 and February 2013, Fonterra supplied the 37.8 metric tonnes of reprocessed WPC80 to eight customers in various countries to make a range of products, including infant formula. Fonterra’s own processing plant at Darnum, Australia, was among the recipients.

In March 2013, finished-product testing for a customer at Darnum identified high levels of Clostridia contamination, which Fonterra traced to the reprocessed WPC80 ingredient. The probable source was the transfer pipe and/or hoses.

Further analysis followed, by both internal and external agencies, and in late July, Fonterra received a draft preliminary report from AgResearch advising of the potential, even likely, presence of the bacterium Clostridium botulinum (C. botulinum).

On 2 August 2013, Fonterra informed the Ministry for Primary Industries (MPI). In the early hours of the following morning, MPI publicly announced that certain batches of Fonterra-produced whey protein concentrate might be contaminated with the botulism causing bacterium (the incident).

A series of precautionary recalls followed - by Fonterra, for the WPC80; and by others for certain infant formula products. There were no cases of illness linked to consumption of the affected products.

The incident, however, caused parents and caregivers here and overseas understandable worry and distress that their babies’ health might be at risk.

International reaction was swift. Some countries, including China, Russia and Brazil, closed their borders to some New Zealand dairy products. Some, such as Malaysia, the Philippines and Thailand, introduced specific product testing requirements. Other countries announced product recalls.

An immediate and significant impact was felt by dairy exporters. Shipments at overseas ports were rejected, payments were withheld and orders were lost. Exporters, particularly those trading in China, have since reported considerable financial loss and redundancies.

On 28 August 2013, MPI announced that further testing in laboratories in New Zealand and the United States had established that the contaminant was the non-pathogenic bacterium Clostridium sporogenes (C. sporogenes), which can cause food spoilage but poses no food safety risk to consumers.

This incident - with its serious effects on New Zealand’s economy and reputation - resulted in the establishment of an independent Government Inquiry.

Terms of Reference

The Inquiry was required to inquire into and report (making any recommendation it thought fit) upon the following:

Inquiry into how the potentially contaminated whey protein concentrate entered the New Zealand and international markets, and how this was subsequently addressed -

A. In relation to this incident of potential contamination of whey protein concentrate at Fonterra's Hautapu plant in 2012:

(i) The causes of this incident;
(ii) the practices used at each stage, from sourcing the raw material to products containing the whey protein concentrate entering the market;
(iii) the timeline of steps taken by Fonterra, and any other party, with regard to testing and reporting the potential contamination of whey protein concentrate;
(iv) the implementation of contingency plans for food safety incidents by Fonterra;
(v) Fonterra's history as a significant manufacturer and exporter of safe dairy products; and
(vi) an examination of the response of the regulator (that is, what actually happened).

This part of the Inquiry was not be undertaken until the Ministry for Primary Industries’ (MPI) compliance investigation was completed, subject to any views the Inquiry reached on the application of section 16 of the Inquiries Act 2013. This part of the Inquiry relied on findings of fact from the MPI compliance investigation, and supplemented this as required.

Inquiry into regulatory and best practice requirements -

B. The requirements of any Acts, Regulations, or other laws, or of any recognised practices, that governed the following aspects of food safety against the background of this incident in relation to the dairy industry, including how those legal and practice requirements interacted with each other:

(i) Quality and integrity of product testing;
(ii) traceability requirements, including the requirements across the supply chain to retailers;
(iii) reporting and risk management decision-making;
(iv) implementation of food safety standards;
(v) contingency plans for food safety and food quality;
(vi) role of regulators, including any recognised agency; and
(vii) potentially affected products, including infant formula.

C. How the matters referred to in paragraphs (b)(i)–(vii) above compared with similar matters in other comparable jurisdictions.

Reporting

The Inquiry was required to report on and make any recommendations it considered fit on:

  • the adequacy of legal and best practice requirements with regard to product testing, traceability, reporting, implementation of food safety standards, contingency planning and role of regulators;
  • any legal or regulatory changes or additions necessary and desirable to prevent or minimise similar incidents; and
  • any changes or additions to operational practices for product testing, traceability, reporting, implementation of food safety standards, contingency planning and response of regulators, to address the lessons from this incident.

Reporting Requirements

The Inquiry was required to report findings and opinions, together with recommendations, required and otherwise, that it thought fit to make in respect of them, to the appointing Ministers in writing in the following sequence:

a) Inquiry into regulatory and best practice requirements:

(i) An interim report is to be provided by no later than three months after notification of the Government Inquiry in the New Zealand Gazette;
(ii)  a final report is to be provided at a date to be specified by the appointing Ministers, following the conclusion of the Ministry for Primary Industries’ investigation and any subsequent Court action;

b) Inquiry into how the potentially contaminated whey protein concentrate entered the New Zealand and international markets, and how this was subsequently addressed, at a date to be specified by the appointing Ministers, following the conclusion of the Ministry for Primary Industries’ investigation and any subsequent Court action.

Presentation of Reports and Disestablishment

The Inquiry presented the first part of its recommendations, Report on New Zealand’s Dairy Food Safety Regulatory System, Government Inquiry into the Whey Protein Concentrate Contamination Incident, on 4 December 2013 (also referred to as the Report on New Zealand’s Dairy Food Safety Regulatory System, Parts B and C - referencing parts B and C of the Terms of Reference for the Inquiry).5

On 12 May 2014 the Inquiry reconvened to address Part A of the Terms of Reference.

The second and final report from the Inquiry, The WPC80 Incident: Causes and Responses, Government Inquiry into the Whey Protein Concentrate Contamination Incident (also referred to as the Report into Part A of the Government’s Inquiry into the Whey Protein Concentrate Contamination Incident), was delivered to ministers for Primary Industries and Food Safety, on 28 November 2014.6

Footnotes:

  1. p.3512, New Zealand Gazette, 12 September 2013, No.126 - New Zealand Gazette website, https://gazette.govt.nz/notice/id/2013-go5757 (accessed 28 December 2014).
  2. p.5, Report on New Zealand’s Dairy Food Safety Regulatory System, Government Inquiry into the Whey Protein Concentrate Contamination Incident, December 2013, Government Inquiry into the Whey Protein Concentrate Contamination Incident (Department of Internal Affairs website), http://www.dia.govt.nz/vwluResources/Government_Whey_Inquiry_Interim_Report_2_Dec_2013/$file/Government_Whey_Inquiry_Interim_Report_2_Dec_2013.pdf (accessed 28 December 2014).
  3. ibid.
  4. Ibid, p.13.
  5. Report on parts B and C of inquiry into whey protein contamination incident received, 4 December 2013 - The Official Website of the New Zealand Government, http://www.beehive.govt.nz/release/report-parts-b-and-c-inquiry-whey-protein-contamination-incident-received (accessed 28 December 2014).
  6. Government Inquiry into the Whey Protein Concentrate Contamination Incident (Department of Internal Affairs website), http://www.dia.govt.nz/Government-Inquiry-into-Whey-Protein-Concentrate-Contamination-Incident (accessed 28 December 2014).
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Agency

AGKD

2013 ‑ 2014

Central government

The Government Inquiry into the Whey Protein Concentrate Contamination Incident was tasked with inquiring into how potentially contaminated whey protein concentrate entered the New Zealand and international markets, and how this was subsequently addressed. The Inquiry was established after an incident of potential contamination of whey protein concentrate at Fonterra's Hautapu plant in 2012.

Wellington

Show History

Establishment

The Government Inquiry into the Whey Protein Concentrate Contamination Incident was established on 10 September 2013 by the Minister for Primary Industries and the Minister for Food Safety pursuant to section 6(3) of the Inquires Act 2013.

The following persons were appointed to and constituted the Inquiry:

  • Miriam Rose Dean, CNZM QC (chairperson);
  • Dr. Anne Marie Astin, PSM (member); and
  • Anthony John Nowell, CNZM (member).1

Professor Alan Reilly, Chief Executive of the Food Safety Authority of Ireland (and Adjunct Associate Professor, University College, Dublin) was appointed to independently peer reviewer of the Inquiry's report.

The Inquiry began considering evidence from 12 September 2013.

The Department of Internal Affairs was responsible for administrative matters relating to the Inquiry.

The establishment of the Inquiry was in response to a potential food contamination incident.  In early August 2013, the biggest food safety scare in New Zealand’s history followed a suspicion that infant formula and possibly other products, too, were infected with botulism-causing Clostridium botulinum. The source of the suspected contamination was whey protein concentrate made by dairy co-operative Fonterra, the output of which constituted nearly 90 per cent of the country’s dairy production at the time.2

Three weeks later, two United States laboratories confirmed the whey protein concentrate had never posed any food safety risk. But that news came too late to prevent widespread concern among parents and caregivers, as well as significant economic harm and damage to reputations. The impact was particularly significant in relation to infant formula, an area of growing importance for New Zealand, with a then estimated $1 billion worth of exports per year.3

Background to the Inquiry4

In February 2012, Fonterra suspected that three batches of whey protein concentrate (WPC80) contained small pieces of unrecovered plastic from a torch sucked into processing equipment.

In May 2012, Fonterra reprocessed - or reworked, to use the industry term - the affected whey protein concentrate into three finished batches totalling 37.8 metric tonnes. The reworking involved some improvisation, including use of a transfer pipe and hoses that were not standard equipment.

Between July 2012 and February 2013, Fonterra supplied the 37.8 metric tonnes of reprocessed WPC80 to eight customers in various countries to make a range of products, including infant formula. Fonterra’s own processing plant at Darnum, Australia, was among the recipients.

In March 2013, finished-product testing for a customer at Darnum identified high levels of Clostridia contamination, which Fonterra traced to the reprocessed WPC80 ingredient. The probable source was the transfer pipe and/or hoses.

Further analysis followed, by both internal and external agencies, and in late July, Fonterra received a draft preliminary report from AgResearch advising of the potential, even likely, presence of the bacterium Clostridium botulinum (C. botulinum).

On 2 August 2013, Fonterra informed the Ministry for Primary Industries (MPI). In the early hours of the following morning, MPI publicly announced that certain batches of Fonterra-produced whey protein concentrate might be contaminated with the botulism causing bacterium (the incident).

A series of precautionary recalls followed - by Fonterra, for the WPC80; and by others for certain infant formula products. There were no cases of illness linked to consumption of the affected products.

The incident, however, caused parents and caregivers here and overseas understandable worry and distress that their babies’ health might be at risk.

International reaction was swift. Some countries, including China, Russia and Brazil, closed their borders to some New Zealand dairy products. Some, such as Malaysia, the Philippines and Thailand, introduced specific product testing requirements. Other countries announced product recalls.

An immediate and significant impact was felt by dairy exporters. Shipments at overseas ports were rejected, payments were withheld and orders were lost. Exporters, particularly those trading in China, have since reported considerable financial loss and redundancies.

On 28 August 2013, MPI announced that further testing in laboratories in New Zealand and the United States had established that the contaminant was the non-pathogenic bacterium Clostridium sporogenes (C. sporogenes), which can cause food spoilage but poses no food safety risk to consumers.

This incident - with its serious effects on New Zealand’s economy and reputation - resulted in the establishment of an independent Government Inquiry.

Terms of Reference

The Inquiry was required to inquire into and report (making any recommendation it thought fit) upon the following:

Inquiry into how the potentially contaminated whey protein concentrate entered the New Zealand and international markets, and how this was subsequently addressed -

A. In relation to this incident of potential contamination of whey protein concentrate at Fonterra's Hautapu plant in 2012:

(i) The causes of this incident;
(ii) the practices used at each stage, from sourcing the raw material to products containing the whey protein concentrate entering the market;
(iii) the timeline of steps taken by Fonterra, and any other party, with regard to testing and reporting the potential contamination of whey protein concentrate;
(iv) the implementation of contingency plans for food safety incidents by Fonterra;
(v) Fonterra's history as a significant manufacturer and exporter of safe dairy products; and
(vi) an examination of the response of the regulator (that is, what actually happened).

This part of the Inquiry was not be undertaken until the Ministry for Primary Industries’ (MPI) compliance investigation was completed, subject to any views the Inquiry reached on the application of section 16 of the Inquiries Act 2013. This part of the Inquiry relied on findings of fact from the MPI compliance investigation, and supplemented this as required.

Inquiry into regulatory and best practice requirements -

B. The requirements of any Acts, Regulations, or other laws, or of any recognised practices, that governed the following aspects of food safety against the background of this incident in relation to the dairy industry, including how those legal and practice requirements interacted with each other:

(i) Quality and integrity of product testing;
(ii) traceability requirements, including the requirements across the supply chain to retailers;
(iii) reporting and risk management decision-making;
(iv) implementation of food safety standards;
(v) contingency plans for food safety and food quality;
(vi) role of regulators, including any recognised agency; and
(vii) potentially affected products, including infant formula.

C. How the matters referred to in paragraphs (b)(i)–(vii) above compared with similar matters in other comparable jurisdictions.

Reporting

The Inquiry was required to report on and make any recommendations it considered fit on:

  • the adequacy of legal and best practice requirements with regard to product testing, traceability, reporting, implementation of food safety standards, contingency planning and role of regulators;
  • any legal or regulatory changes or additions necessary and desirable to prevent or minimise similar incidents; and
  • any changes or additions to operational practices for product testing, traceability, reporting, implementation of food safety standards, contingency planning and response of regulators, to address the lessons from this incident.

Reporting Requirements

The Inquiry was required to report findings and opinions, together with recommendations, required and otherwise, that it thought fit to make in respect of them, to the appointing Ministers in writing in the following sequence:

a) Inquiry into regulatory and best practice requirements:

(i) An interim report is to be provided by no later than three months after notification of the Government Inquiry in the New Zealand Gazette;
(ii)  a final report is to be provided at a date to be specified by the appointing Ministers, following the conclusion of the Ministry for Primary Industries’ investigation and any subsequent Court action;

b) Inquiry into how the potentially contaminated whey protein concentrate entered the New Zealand and international markets, and how this was subsequently addressed, at a date to be specified by the appointing Ministers, following the conclusion of the Ministry for Primary Industries’ investigation and any subsequent Court action.

Presentation of Reports and Disestablishment

The Inquiry presented the first part of its recommendations, Report on New Zealand’s Dairy Food Safety Regulatory System, Government Inquiry into the Whey Protein Concentrate Contamination Incident, on 4 December 2013 (also referred to as the Report on New Zealand’s Dairy Food Safety Regulatory System, Parts B and C - referencing parts B and C of the Terms of Reference for the Inquiry).5

On 12 May 2014 the Inquiry reconvened to address Part A of the Terms of Reference.

The second and final report from the Inquiry, The WPC80 Incident: Causes and Responses, Government Inquiry into the Whey Protein Concentrate Contamination Incident (also referred to as the Report into Part A of the Government’s Inquiry into the Whey Protein Concentrate Contamination Incident), was delivered to ministers for Primary Industries and Food Safety, on 28 November 2014.6

Footnotes:

  1. p.3512, New Zealand Gazette, 12 September 2013, No.126 - New Zealand Gazette website, https://gazette.govt.nz/notice/id/2013-go5757 (accessed 28 December 2014).
  2. p.5, Report on New Zealand’s Dairy Food Safety Regulatory System, Government Inquiry into the Whey Protein Concentrate Contamination Incident, December 2013, Government Inquiry into the Whey Protein Concentrate Contamination Incident (Department of Internal Affairs website), http://www.dia.govt.nz/vwluResources/Government_Whey_Inquiry_Interim_Report_2_Dec_2013/$file/Government_Whey_Inquiry_Interim_Report_2_Dec_2013.pdf (accessed 28 December 2014).
  3. ibid.
  4. Ibid, p.13.
  5. Report on parts B and C of inquiry into whey protein contamination incident received, 4 December 2013 - The Official Website of the New Zealand Government, http://www.beehive.govt.nz/release/report-parts-b-and-c-inquiry-whey-protein-contamination-incident-received (accessed 28 December 2014).
  6. Government Inquiry into the Whey Protein Concentrate Contamination Incident (Department of Internal Affairs website), http://www.dia.govt.nz/Government-Inquiry-into-Whey-Protein-Concentrate-Contamination-Incident (accessed 28 December 2014).

The establishment date of the Government Inquiry into the Whey Protein Concentrate Contamination Incident is based on the date terms of reference were issued, 10 September 2013. The disestablishment date of the Inquiry is based on the date the second and final part of the Inquiry’s report was presented to the Ministers for Primary Industries and Food Safety, 28 November 2014.


  1. Government Inquiry into the Whey Protein Concentrate Contamination Incident (Department of Internal Affairs website), http://www.dia.govt.nz/Government-Inquiry-into-Whey-Protein-Concentrate-Contamination-incident (accessed 28 December 2014).
  2. New Zealand Gazette website, https://www.gazette.govt.nz/ (accessed 28 December 2014).
  3. The Official Website of the New Zealand Government, http://www.beehive.govt.nz/ (accessed 28 December 2014).
  4. New Zealand Legislation website (Parliamentary Counsel Office), http://www.legislation.govt.nz (accessed 28 December 2014).




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