Transcript Slide 1
New Zealand Food Safety Authority
Overview
– NZFSA Food Regulatory System
– – – – – – – – –
NZFSA purpose Importance of Food to New Zealand NZFSA structure Risk management framework Regulatory model Food Standards Accreditation bodies and third party agencies Imported foods Official assurances and health certificates
Purpose
Protect and promote public health and food safety Enhance and sustain access to markets for our food and food related products
New Zealand Government Objectives
• Reduce food-borne illness • Protect consumers • Facilitate trade and commerce in animal and plant products
NZFSA is New Zealand’s competent authority for food & animal products
New Zealand Food Safety Authority
• Regulatory agency • Doesn’t support or promote industry • Regulates all domestic food production • Regulates the food safety of all imports
NZFSA Operating Context
Science driven & risk-based approach
Consistency with international obligations (SPS Agreement)
Openness and Transparency
Minimal costs to business
Protection of New Zealand’s reputation through robustness of standards and integrity of programmes and official assurances
NZFSA Scope
• Food and food related production, processing and sale • Imported food • Exported food and animal products • Wine processing and export • Import, manufacture, sale, distribution and use of agricultural compounds and veterinary medicines
Key Policies / Objectives
Key policies of New Zealand’s food regulatory programme
• People processing and selling food are responsible for food safety & suitability and meeting any market access requirements • Consumers are protected and foodborne illness is reduced • Trade in food and food-related products is facilitated • Regulatory compliance costs and interventions are minimised consistent with adequate regulatory control
Some things we can’t control
Importance of food to New Zealand
Food and Agriculture are New Zealand’s largest business….
Primary Production Farm Numbers
Horticulture, 1917 Pig, 327 Dairy, 11400 Crop, 1878 Deer, 1581 Sheep & Beef, 29241
6 4 2 12 10
Food Exports
8 Dairy Horticulture Seafood Wine NZ Industry Meat Other
New Zealand & World Agricultural Production and Exports
• 3% of world dairy production but 33% of world dairy exports • 7% of world sheepmeat production but 50% of world sheep exports • 1% of world beef production and 7 % of world beef exports • 80% of world venison exports
NZFSA Structure
NZFSA
• Single Food Safety Agency • Formed in 2002 from the Food Section of the New Zealand Ministry of Health and the Regulatory Authority of the Ministry of Agriculture and Forestry
Future of NZFSA
Amalgamation with Ministry of Agriculture and Forestry
• NZFSA has been merged back into MAF • Amalgamation/restructure continues to be worked through • Business as usual - most external stakeholders will not see any difference in the functions or services provided • Administration of food law continues as a priority • Work programmes continue unchanged
NZFSA Structure
Acting Deputy Director General (Food Safety)
Carol Barnao
Executive Assistant
Adele Gilliver
Director Communications
Katie Mathison
Director Finance
Gary Lewis
Director Market Access
Tony Zohrab
Director Science & Director Policy
Carole Inkster
Joint Food Standards
Steve Hathaway
Director Approvals & Agricultural Compounds and Veterinary Medicines (ACVM)
Debbie Morris
Acting Director Standards
Tony Zohrab
Director Compliance & Investigation
Geoff Allen
Director Verification Agency
Steve Gilbert
Risk Management Framework
NZFSA’s Risk Management Framework
• • • Reflects three components of risk analysis
Risk assessment
– scientifically based process consisting of hazard identification, characterisation, exposure assessment and risk characterisation
Risk management
– weighing options, selecting and implementing appropriate control options
Risk communication
– exchange of information and opinions concerning risk between all parties throughout the process RMF includes recent examples at each step Makes public health goals more explicit
NZFSA’s Risk Management Framework
Step 1 Step 4 Step 2 Step 3
NZFSA Structure / Groups
Policy Framework Science
• • •
Emerging issues Risk assessments Equivalency cases Standards New Zealand Standards Export Standards Monitoring/Review Compliance Monitoring/Surveillance Implementation Approvals/ Registrations Verification Imported Foods Enforcement Certification
Infrastructure platform
Regulatory Cycle
Government Statement: Better Regulation, Less Regulation Regulatory Plans Preliminary Assessment Ex-post Review Programme Annual Regulatory Reform Bill Regulatory Scanning Monitoring and Review Business Consultation Website Post implementation Review Policy Development
Regulatory
Implementation
Life Cycle
Consultation Decision RIS publication
Impact analysis
RIS disclosure statement RIS quality assurance Ministerial certification
Risk in perspective
Our Regulatory Model
NZFSA – How We Work
• NZFSA Risk Management Framework • NZFSA Regulatory Model • Application of the model by countries importing New Zealand animal and plant products
Generic framework for managing risk
CONSULTATION & RISK COMMUNICATION STEP 1 STEP 2 STEP 3 STEP 4
Preliminary risk management activities Assessment of risk management options Implementation of the risk management decision Monitoring and review
Regulatory model
Regulator Accredited Verifiers
AUDIT AUDIT AUDIT
Industry
Risk Management Plans designed to meet regulatory/market access requirements
Consumers Industry Accredited Verifiers Regulator
Regulatory model
Truthfully labeled, safe and wholesome food/beverages Meet standards using Risk Based Management Plans Independent Audit Set standards for consumer protection Provide assurance(s)
Regulator Regulator
Function
Standards Official SPS & TBT assurances Approvals, Accreditations Compliance, Enforcement
Output
Set requirements
• Domestic (technical and operational) • • Bilateral trade (negotiated agreements) International eg. Codex
SPS measures & TBT requirements designed to provide product that is safe and suitable
• NZ consumers/citizens • Importing country governments by way of official certification
Approve system components
• Third party verifiers • • Food Control Plans Laboratories and other ‘components’ of the programme
Assess system components
• Remedy failures and non-compliance issues • Prosecute people/organisations violating the law
Independent Verification
Recognised Verifiers
AUDIT AUDIT AUDIT Function
AUDIT Risk Management Plans
Output
Verification that Risk Management Plans are in place and being complied with
• • • • Audit against the Plan Ensure compliance with plan Provide ‘authorisation’ for government certification Recognised verifiers/agencies meet ISO 17020
Regulated Industries
Function
Apply approved Risk Management Plans Industries must meet New Zealand and / or market access requirements
Output
Operators processing in compliance with relevant food standards Product that is “fitness for purpose”, that is truthfully labeled, wholesome and “safe and suitable” for domestic market Product for export that meets the requirements of the market
Provide assurances Set standards Approve & accredit against standards • Laboratories • Evaluators • Independent Verifiers • Food Control Plans Assess Total Programme Compliance & Enforcement
Regulatory Model Application of the model
Recognised Evaluators Evaluate Food Control Plans and recommend approval
uses Regulator uses
Accreditation Bodies
IANZ/JAS-ANZ
Expertise in conformance assessment against primary & secondary criteria
Independent Verifiers 1 ° criteria 2 ° criteria
= ISO 17020 = tech. competencies etc
Regulated Industries Approved Risk Management Plans LABORATORIES 1 ° criteria 2 ° criteria
= ISO 17020 = tech. competencies etc
NZFSA Regulatory Model
Importing country relationship with New Zealand
Importing Country Controlling
Sample audit at point of entry
Authority External Review
Assess performance against negotiated standards
Audi t New Zealand Controlling Authority
Set standards, assess programme performance. Provide official assurances through certification
Regulator
AUDIT
Verifiers
AUDIT Sample audit at next to levels to judge integrity of Competent Authority
Verification Audit
Assess processors’ performance Ensures compliance, “authenticate” exports
Regulated Industries
Meet standards
Processors and ASURE Risk based management plans
Legislation Administered Animal Products Act:
Primary production and animal product exports Health assurances for exports (role of ‘Competent Authority’)
Agricultural Compounds & Veterinary Medicines Act:
Pesticides & veterinary medicines, stock-foods, fertilizers
Food Act:
Food for sale on domestic market Imports - protection of human health
Wine Act
Wine for sale on domestic market Health assurances for exports
Food Chain - Legislation
Primary Production Primary Processing Secondary Processing Domestic Sale ACVM 1997 Animal Products Act 1999 Wine Act Food Act 1981
Food Act – Domestic Focus
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Food for sale on local market: Safety Suitability for New Zealand consumers Implementing standards e.g. border checks Controls on Imported Food:
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Safety
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Suitability for New Zealand consumers Surveillance to generate country sanitary status Response in the case of importation of unsafe and unsuitable food Investigations of complaints, may lead to prosecutions.
• •
Domestic food processing and sale of all food, including: Restaurants Food service industry
Australian Relationship
Animal Products Act Export Focused
Primary production standards: Safety Suitability for all consumers
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Bilateral market access standards as negotiated for: Safety, and Suitability Controls to enable official assurances for animal products covering safety and suitability. (Biosecurity NZ cover live animals and germplasm)
Agricultural Compounds and Veterinary Medicines Act
Registration of Agricultural Compounds and Veterinary Medicines: Includes pesticides for use on animals and plants, vertebrate toxic agents
• • •
Biosecurity Animal welfare Food safety and suitability
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Imports
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Manufacture
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Sale and Use Monitoring compliance and use.
Investigations of complaints.
May lead to prosecutions
Food Standards
ANIMAL PRODUCTS ACT 1999
Covers • Primary processing of animal products Objective • Manage risks to human and animal health from animal material and products • Ensure products are fit for the intended purpose • Facilitate market access
Regulatory Structure
• Act • Regulations • Standards, Specifications and Notices • Criteria • Codes of Practice • Templates (generic risk management plans) • Guidance
RISK MANAGEMENT PROGRAMMES
• Documented HACCP based programme developed by company • HACCP central to the programme • Supporting systems integrated • Identify and manage biological, chemical and physical hazards • Wholesomeness • Truthful labelling • Outcome - Products fit for intended purpose • Businesses required by law to allow verifier freedom of access
Risk Management Programme Process OPERATOR RECOGNISED AGENCY NEW ZEALAND FOOD SAFETY AUTHORITY VERIFICATION (RECOGNISED AGENCY) DEVELOPMENT OF RMP CONFIRMATION OF VALIDITY EVALAUTION ASSESSMENT REGISTRATION OPERATION CESSATION NZFSA’S COMPLIANCE AND INVESTIGATION GROUP - AUDITING OF SYSTEM
Accreditation Bodies and Third Party Agencies
The Regulatory Model
Monitoring, performance measurement Reporting, communication
The Contestable environment
• Provision for non-public sector agencies and individuals to be recognised by NZFSA to perform specific tasks • Provides a contestable environment • Maintains integrity and confidence through government oversight • NZFSA specifies mandatory requirements for recognition and performance measurement criteria • Pre-requisite for Agencies undertaking verification of programmes is typically accreditation to ISO 17020 • Pre-requisite for Laboratories is ISO 17025
Recognised Agencies
• Third party verification agencies recognised to act as agents for government • Verification and other functions, such as evaluation of RMPs, verification of export requirements, assistance with sampling • Have legal duties • Cannot apply sanctions • Must report to NZFSA – this is used by NZFSA to monitor both industry and agency performance • Must manage conflict of interest
Accreditation background
• Two accreditation bodies in New Zealand – International Accreditation New Zealand
(IANZ)
– Joint Accreditation System of Australia and New Zealand
(JAS-ANZ)
• Both belong to international organisations • Both are subject to evaluation by their peers • Accreditation agencies use ISO standards
and
NZFSA supplementary criteria as the basis for accreditation • NZFSA may recognise third party organisations to provide evaluation and verification functions once they provide evidence of accreditation
Relationship NZFSA/Accreditation Bodies
• Complete independence • NZFSA has input into and oversight of the accreditation process through a variety of mechanisms: – NZFSA staff used as technical experts – Memorandum of Understanding agreements with both accreditation bodies – NZFSA systems audits of overall system as well as specific elements • NZFSA staff on accreditation body committees (JAS-ANZ Technical Advisory Council and IANZ Inspection Body Professional Advisory Committee)
Performance measures
• Regular agency reporting • Performance based assessment • Demonstrated history of compliance with ISO 17020 and NZFSA requirements • Regular review of verification reports • Audits by NZFSA Compliance & Investigation Group
NZFSA Compliance & Investigation Group
• 3 Teams – Compliance (audit) team, – Response (investigation, prosecution, operational response in incidents and emergencies, e.g. recalls) team, – Business services (based in Wellington), • Members spread throughout New Zealand, • Variety of qualifications & backgrounds
Compliance & Investigation Group
Three main areas of activity across all food areas: • Compliance »systems auditing • Operational Response »investigation, »enforcement • Emergency Response
Compliance & Investigation Group
Technical audit, investigation & enforcement functions across all food areas
:
• Provide auditable mechanism of assurance • Internal audit • Enforce legal obligations • Provide legal enforcement advice • Eyes and ears of “competent authority” • Technical expertise (IANZ accreditation) • Trouble shooting (investigations) • Sanctions & prosecutions
Compliance & Investigation Group
Food emergency contingency planning, abnormal food event response co-ordination: • Establish national and international response protocols for food emergencies, • Liaise with other agencies, • Co-ordinate NZFSA contribution to emergency responses, • Initiate and oversee food recalls, • Co-ordinate other adverse food events.
Imported Foods
Domestic Market
• Over 35,000 food businesses • Estimated 200,000 occasional food sellers • Food Service - $5 billion value • Retail Sales - $13.8 billion value • Domestic Processing - $13.8 billion value
Imported Food
• Around 20% of food is imported • $2.7 billion per annum • Major items – Grains and Baking Goods – Beverages – Fruit and Vegetables – Fish, Meat and Dairy Products (40% of pork consumed in New Zealand) – Sugars – Cocoa
Prescribed Food
• High risk foods are placed on a list that prescribes what supporting information or testing is required when the food is imported • Based on known hazards associated with the food • Importer responsible for compliance
Monitoring of Imported Food
• Low level monitoring • Based on known hazards in the foods chosen • Relatively new programme • Selection of food/parameter combinations comes from various sources including other NZFSA monitoring programmes, international alerts/incidents, historic findings, etc (as for domestic programmes)
Intelligence Gathering
• Scan for emerging hazards in food • Assess potential to impact New Zealand consumers • Information feeds into our own risk assessment • Findings link to: – monitoring – consideration for the “high risk” foods list – liaison with other Authorities if necessary (e.g. melamine)
Official Assurances and Health Certificates
Principles Applied
• Exporters of animal products registered • All processors of animal products for export: – Registered – Operating under a Risk Management Programme – Are subject to regular verification
Reporting summary of performance Reporting of critical non-compliances Monitoring of trends Intervention for critical non compliances if required
NZFSA
Regulatory Model Reporting summary of accredited organisations and individuals
Accreditation Process
(ISO 17020 + NZFSA requirements)
Accreditation body (IANZ / JAS-ANZ) Third Party Agencies (TPAs)
Reporting of non-compliances Regular reporting Reporting on resolution of audit non compliances
Regulated parties
Non-Conforming Product
• Product that has not been manufactured in full accordance with an NZFSA approved programme, or • Product that does not meet food safety criteria • Non-conforming Product must – be notified (through third party verifier) – withdrawn or recalled from trade – detained (strict movement controls apply) • Disposal follows an official process
Application for Health Certificates
• Supporting information required will vary based on food type • Applicant must make certain official declarations • NZFSA E-cert system used • Online application for certificates • Arrangements in place with a number of Authorities to receive/access information electronically
E-cert
• Comprehensive system • Secure • Integrated with base standards and requirements • Allows paper (past) and paperless (future) option
Monitoring of Official Assurances External Review
Assess performance against negotiated standards
New Zealand Competent Authority
Set standards, assess programme performance Provide official assurances through certification
Third party verification
Assess processors’ performance Ensures compliance, ‘authenticate’ exports
Regulated Industries
Meet standards Sample audit at port of entry
Importing Country Competent Authority AUDIT
Sample audit at next two levels to judge integrity of Competent Authority
Regulator AUDIT Independent Verifiers ‘AUDIT’ Industry Management Plans
System Audit and Integrity
• Controls within New Zealand subject to verification • NZFSA Compliance and Investigation Group also audit the full system • Scrutiny of product by the importing country • Some Competent Authorities will also send auditors to review the systems applied (including the E.U.)
International Recognition
New Zealand Food Control Standards recognised through: – Treaties – Equivalence determinations – Memorandum of Understanding Advantage is that Importing countries can: • have a high level of statistical confidence that food of New Zealand origin will meet requirements • redirect resources to the foods of real concern