NEW ZEALAND GAZETTE, No. 126

12 SEPTEMBER 2013

Product:
Dianeal PD-4 Peritoneal Dialysis Solution

Active Ingredients:

• Calcium chloride dihydrate 0.181g/L
• Glucose monohydrate 5.45g/L
• Magnesium chloride hexahydrate 0.0503g/L
• Sodium chloride 5.33g/L
• Sodium lactate 7.4g/L

Dosage Form:
Dialysis solution

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturer:
Baxter Healthcare Pty Limited, Old Toongabbie, Australia

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 5th day of September 2013.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Internal Affairs

Inquiries Act 2013

Establishment of the Government Inquiry into the Whey Protein Concentrate Contamination Incident

Pursuant to section 6(3) of the Inquiries Act 2013, I, The Honourable Nathan Guy, Minister for Primary Industries, and I, The Honourable Nikki Kaye, Minister for Food Safety, hereby establish the Government Inquiry into the Whey Protein Concentrate Contamination Incident (“Inquiry”).

Membership

The following persons are appointed to and constitute the Inquiry:

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

Terms of Reference

Background

New Zealand has a reputation as a credible and trusted supplier of safe and suitable food to both domestic and international markets. This well-deserved reputation is a vital element in the continuing growth and productivity of the food industry.

Exporting food is critical to New Zealand’s economy, with the food industry making up half of New Zealand’s merchandise export value. New Zealand has an excellent track record of exporting safe food, and our food safety system is considered world-leading.

The whey protein concentrate (“WPC”) contamination incident risks damaging the reputation we have worked hard to gain.

This Inquiry is about strengthening an already strong system, to ensure that New Zealand food products retain their status as among the world’s safest and most desired.

Appointment and Order of Reference

This Inquiry will inquire into and report (making any recommendation it thinks 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 will not be undertaken until the Ministry for Primary Industries’ (MPI) compliance investigation is completed, subject to any views the Inquiry reaches on the application of section 16 of the Inquiries Act 2013.

This part of the Inquiry will rely on findings of fact from the MPI compliance investigation and supplement 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 govern 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 interact 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 compare with similar matters in other comparable jurisdictions.

Matters Upon or for Which Recommendations Required

The Inquiry will report on and make any recommendations it considers fit on: