Government Inquiry into the Whey Protein Concentrate Contamination Incident Provisional list of issues – phase one

The Inquiry has  developed a provisional list of issues / questions which it presently considers will need evaluating in order to address its terms of reference.   The list is provided for the assistance of those wishing to engage with the Inquiry.  It is to be emphasised that the list is provisional; high level; and covers all aspects of, and participants in, the dairy food safety system.  Some issues/questions will be relevant to particular organisations; some will not.  Also, as will be apparent, some questions can be answered shortly; others will require more detail.  It is implicit that in considering these questions issues of practicability, cost, markets and reputation should be taken into account.  The Inquiry will review the list from time to time.  Any revised list will be provided without delay.  For those organisations that will be providing written submissions the Inquiry will be greatly assisted if you can broadly follow the outline of issues.

 

TERMS OF REFERENCE PARAGRAPHS (B) AND (C) – THE REGULATORY FRAMEWORK FROM A POLICY AND BEST PRACTICE PERSPECTIVE

1.    International best practice for food safety in the dairy industry

1.1     What are the appropriate international comparators (countries, international bodies, model laws)?

1.2     To what extent is there international consensus about regulatory best principles and practice, including the respective roles of prescriptive and outcome-based regulation?  Are there any relevant trends?

1.3     What are the key relevant features or principles of the comparator systems?  Are there key or high-level differences from New Zealand’s arrangements?

1.4     Is New Zealand recognised as having particular areas of excellence and by whom?

1.5     Are there any relevant international reviews or academic works the Inquiry should take into account?

1.6     What future challenges do international food safety systems need to address?

2.    New Zealand’s food safety performance in the dairy industry

2.1     How does New Zealand’s incidence of food-borne illness compare with comparable jurisdictions?

• For whey protein
• For other dairy food
• Generally in relation to all food types

2.2     How does New Zealand compare in other relevant indicators/metrics?

• Incidence of dairy product (and food more generally) rejected by regulatory authorities and/or customers / markets on food safety grounds? 
• Number of dairy product recalls?
• Results of international dairy audits, both public and private?
• Any other international dairy benchmarks?

2.3     Does New Zealand invest sufficiently in research and development in food safety?

3.    Regulatory design for food safety in the dairy industry

3.1     The high-level regulatory framework

• What are the origins of and policy behind New Zealand’s regulatory framework?
• Does the current regime strike the right balance between outcome-based regulation and prescription?
• Are the divisions of roles and responsibilities between Government and the private sector appropriate?
• Does the current regime align with New Zealand’s international trade objectives?
• Is the use of primary, secondary and, in particular, tertiary regulation (eg notices, specifications, approved criteria, guidance material) appropriate, understood and sufficiently accessible for industry?
• Is the New Zealand regime consistent with international best practice?
• Is there an appropriate relationship between the Government’s role as promoter/supporter of the dairy sector and the regulator’s role?  

3.2     The use and verification of risk-management programmes

• Requirements for risk-management programmes
  • Are they appropriate?
  • Are they sufficiently clear?
  • Are they appropriate for small, as well as large, operators?
• Verification and accreditation systems
  • Is New Zealand’s system of non-Governmental verifiers (recognised agencies) consistent with best practice?
  • Do recognised agencies have the appropriate incentives to perform their roles robustly?
  • What evidence exists that the verification system is, or is not, operating well?
  • What evidence exists that the accreditation system for recognised agencies is, or is not, operating well?
  • Are the relationships between the regulator, verifiers and accreditation bodies appropriate?
  • Are any modifications / improvements to the system warranted?

4.    The regulator’s role for food safety in the dairy industry

4.1  Structure

• Is the Ministry for Primary Industries (MPI)’s internal structure (in relation to both the dairy industry and food safety generally) appropriate?
• Is there sufficient transparency and appropriate oversight of MPI’s food safety controls?
• Does food safety have adequate leadership and emphasis within MPI?
• Are there synergies between food safety and other regulatory functions, and if so, are these being maximised?
• Does the regulator have sufficient international credibility and connections?
• Does the regulator appropriately manage its multiple roles (eg policy, enforcement, facilitation of trade, guidance) and any conflict issues that arise?
• Are any modifications / improvements to the structure warranted?

4.2     Compliance and enforcement

• Strategy
  • What is the regulator’s compliance and enforcement strategy?
  • Is that strategy regularly monitored and reviewed?
  • Is it consistent with best practice?

•  Powers and sanctions

  • Does the regulator have adequate compliance tools and enforcement powers, and are these used appropriately?
  • Are the penalties for non-compliance appropriate?
• Performance indicators
  • What performance indicators are measured by the regulator across the food safety system, including dairy?
  • Does the regulator adequately analyse, respond to, and report on, these indicators?
  • How does New Zealand compare in relation to, for example:
    • Number, frequency, quality and results of audits (across the whole system including regulator, accreditor, verifier, industry)
    • Number, frequency, quality and results of product tests
    • Number, frequency, quality and results of compliance audits / inspections
    • Number of officers / inspectors
    • Training, qualifications and capability of officers / inspectors
    • Action taken when non-conformance is discovered?
    • Number of warnings / interventions
    • Number of successful prosecutions
    • Enforcement budget

4.3     Communication and responsiveness

• Are the regulator’s risk-communication and crisis-management policies effective?
• Are they well integrated with other relevant agencies?
• Are they tested?
• Are they well implemented?
• Is the regulator sufficiently responsive to industry?

4.4     Capacity and capability

• Are there any capacity or capability issues with the regulator?
• Are there any retention / recruitment issues with the regulator?

5.   The dairy industry

5.1  Organisation and leadership

• Does food safety have adequate leadership and emphasis within the New Zealand dairy industry (taking into account differences in size and scope)?
• Does the New Zealand dairy industry have sufficient international credibility and engagement?

5.2  Compliance

• Is New Zealand dairy-industry practice consistent with international best practice?
• What performance indicators are measured within the industry across the food safety system?  
• Does industry adequately analyse and respond to such indicators?
• To what extent does industry audit and monitor its food safety performance?

5.3  Communication and responsiveness

• Are industry’s risk-communication and crisis-management policies effective? 
• Are they tested? 
• Are they well implemented?
• Is the industry sufficiently responsive to the regulator?

5.4  Capacity and capability

• Are there any known or perceived issues with skills, knowledge, leadership, governance or capability within the industry?

6.    Specific issues in relation to food safety in the dairy industry (not covered above)

6.1     Development and implementation of food safety standards

• Does New Zealand’s development and implementation of the relevant standards conform to international best practice?
• Is New Zealand adequately and effectively represented in international food safety fora?
• What guidance is provided, or available, to the dairy industry on compliance and implementation, and by whom?
• How does industry demonstrate compliance with food safety standards?

6.2     Product testing and notification by the dairy industry

• Is the regulatory framework for testing in New Zealand appropriate?
• Does New Zealand have adequate capability and capacity to undertake appropriate testing?
• Are there adequate requirements for, and oversight of, procedures in risk-management programmes to determine:
  • When to send samples for testing;
  • What samples to test;
  • What should be tested for;
  • What laboratories / procedures to use;
  • The response to test results, including when to notify the regulator, recognised agency and/or customer?
• How does New Zealand’s testing and notification regime compare with international best practice?
• Should notification thresholds and/or procedures differ according to the nature of the pathogen, product or consumer (including vulnerable populations)?
• How do the specific requirements for notification to the regulator, recognised agencies and/or customer compare with international best practice?
• Does the regulator adequately audit and oversee testing procedures and results in New Zealand?
• Are the testing quality-management systems appropriate?
• Are any modifications / improvements warranted?

6.3     Traceability, contingency planning and recall procedures

• Is the regulatory framework governing traceability, contingency planning and recall procedures appropriate?
• Are there adequate requirements for, and oversight of, procedures to ensure:
  • Potentially contaminated products are sufficiently traceable
  • Producers have adequate procedures to cover recalls, including communication and public notification
• Do the regulator and industry engage in simulated exercises to test the suitability of traceability and recall procedures?
• Are the results of any such exercises monitored and used to improve the system?
• How does New Zealand determine the threshold for, and scope of, product recalls?  Is this appropriate?
• Are any modifications / improvements warranted?

6.4     Infant formula

• Does the regulatory regime in New Zealand provide sufficient assurance that infant formula and its component ingredients will be manufactured in conformity with international best practice?
• Are there any specific issues the Inquiry should consider in relation to infant formula food safety?

 

23 September 2013