Export Certification Standard - System Overview and Requirements

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REVIEW	This Biosecurity New Zealand standard is subject to periodic review.
ENDORSEMENT	This Biosecurity New Zealand standard is hereby endorsed.
Director PreClearance Biosecurity New Zealand
Date	1 June 2006

Biosecurity New Zealand
MAF
P O Box 2526
Wellington
New Zealand

TABLE OF CONTENTS

• 1 INTRODUCTION
• 1.1 Background
• 1.2 Purpose
• 1.3 References
• 1.4 Definitions
• 2. INTERNATIONAL OBLIGATIONS
• 3. MAF PRINCIPLES FOR EXPORT CERTIFICATION
• 4. REGULATORY MODEL
• 4.1 Options for export phytosanitary certification
• 4.2 System overview, roles and responsibilities
  • 4.2.1 System overview
  • 4.2.2 Biosecurity New Zealand role
  • 4.2.3 Independent Verification Agencies role
  • 4.2.4 Organisation role
  • 4.2.5 Industry role
• 4.3 Structure of and setting standards
  • 4.3.1 Identification of importing country phytosanitary requirements (ICPR)
  • 4.3.2 Provision of additional declarations
  • 4.3.3 Principles of audit frequency
• 4.4 Requests for post export official assurances
• 4.5 Biosecurity New Zealand cost recovery fees
• APPENDIX 1: REFERENCES
• APPENDIX 2 DEFINITIONS

1 INTRODUCTION

1.1 Background

The Biosecurity New Zealand export certification system utilises the principles contained within ISO 9001 and international standards for phytosanitary measures (ISPMs) to develop a series of operating standards. These standards contain specifications, policies, procedures, and the primary roles and responsibilities for participating parties involved in export certification.

This export certification system operates through the delegation of authority by Biosecurity New Zealand to authorised Independent Verification Agencies (IVAs) and approved Organisations to carry out certification services and activities on behalf of Biosecurity New Zealand.

This standard “System Overview and Requirements” provides an overview of the policies and general requirements for Biosecurity New Zealand’s Plant (including forestry) Export Certification system.

Biosecurity New Zealand has developed standards and technical requirements for the delegation of authority for the provision of phytosanitary and seed export certification services and activities.

The series of plant export certification standards can be found on the Biosecurity New Zealand websites:

http://www.biosecurity.govt.nz/commercial-exports/forestry-exports/export-certification-standards

http://www.biosecurity.govt.nz/commercial-exports/plant-exports/export-certification-standards

1.2 Purpose

This standard provides an overview of the policies and general requirements for Biosecurity New Zealand Export Certification system, and in particular:

• i. International Obligations: The international context and regulations for phytosanitary certification and plant trade.
• ii. MAF Principles for Export Certification: The MAF policy framework for export certification.
• iii. Regulatory Model: The MAF regulatory model for export certification.
• iv. System Overview, Roles and Responsibilities: How the Biosecurity New Zealand export certification system operates.

1.3 References

Refer to Appendix 1.

1.4 Definitions

Refer to Appendix 2.

2. INTERNATIONAL OBLIGATIONS

New Zealand is a contracting party to international agreements and conventions relevant to export certification. The FAO International Plant Protection Convention (IPPC) is an international treaty that is designed to prevent the spread and introduction of pests of plants and plant products throughout the world. Also, it promotes the establishment of appropriate measures to control plant pests.

Part of New Zealand’s commitment to the IPPC is to provide export phytosanitary certification, to ensure that the international trading of plants and plant products does not spread unwanted plant pests, especially to countries where these pests do not already exist or are under official control. The New Zealand Government has designated MAF as the National Plant Protection Organisation (NPPO) to ensure that New Zealand is meeting the requirements of the IPPC.

The IPPC is recognised also by the World Trade Organisation (WTO) under The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), as the international organisation responsible for phytosanitary standard setting and harmonisation of phytosanitary measures that affect trade. Most countries that are signatories to the IPPC require phytosanitary certification from exporting countries.

Under the IPPC a series of international standards for phytosanitary measures (ISPMs) have been developed. These impact on, and provide guidelines for export certification.

The IPPC and SPS require that any phytosanitary measures must be:

• i. Transparent;
• ii. Technically justified; and
• iii. Sufficient only to protect plant, animal or human life.

The phytosanitary certificate:

• i. Is a government-to-government certificate of compliance and must provide specific IPPC data elements;
• ii. States that the produce has been inspected prior to export and meets the importing country’s phytosanitary requirements;
• iii. Is issued by the Ministry of Agriculture and Forestry (MAF) as the NPPO.

Phytosanitary certification also may be integrated into other export certification assurance programmes. As an example Biosecurity New Zealand has designed and operates an export certification system that integrates the delivery of official phytosanitary and seed varietal assurances to meet importing countries requirements in relation to arable seed. This integrated system applies to seeds produced in New Zealand and allows for the verification of seed production procedures compliance with the rules and requirements of the various international Organisations concerned with the international movement and testing of seed. These rules and requirements currently include those of the IPPC, the Organisation for Economic Co-operation and Development (OECD), the European Union (EU), the International Seed Testing Association (ISTA) and the New Zealand Seed Quality Management Authority (SQMA) relating to plant health and varietal trueness to type certification.

Within the integrated export certification system for arable seeds, MAF is the New Zealand:

• i. National Plant Protection Organisation under the IPPC;
• ii. Designated control agency for the EU seeds scheme;
• iii. Designated authority for the OECD seed schemes;
• iv. Designated authority for ISTA; and
• v. Certification authority for SQMA.

New Zealand is a member country of the Organisation for Economic Co-operation and Development (OECD) and is a participating member of the OECD Seed Schemes. Participation in these schemes has resulted in MAF being the National Designated Authority for the administration of the Schemes Rules, and as such, the Designated Authority for the International Seed Testing Association (ISTA). The requirements of these Organisations are integrated with the New Zealand schemes seed sampling and testing processes.

3. MAF PRINCIPLES FOR EXPORT CERTIFICATION

MAF is in the process of developing a set of principles associated with the provision of MAF official assurances that will apply to all regimes under which the Ministry provides government-to-government assurances for agricultural, horticultural, forestry and food exports. In particular, the principles apply to the devolution of verification and organisation roles and responsibilities to support the ongoing provision of credible official assurances.

The principles concern the provision of official assurances to facilitate the entry of horticultural, forestry, and food products where importing countries require official assurances as the initial means of entry. There is no New Zealand legislative requirement for phytosanitary certification of exported products. The requirement for phytosanitary certification is determined by the importing country.

4. REGULATORY MODEL

There is now a broadly endorsed worldwide trend towards the introduction of process control risk and risk management as a means of producing credible official assurances. These mechanisms or systems are progressively replacing historical quality control through end-point inspection as the principal assurance process. The introduction of risk-based management systems, including Hazard Analysis Critical Control Point (HACCP) is a sound example of this. The onus for producing products that comply with specified requirements has shifted to the producer, processor, manufacturer and retailer, while the onus on government is to set the frameworks for efficient and effective official assurance regimes to verify these requirements are being met.

The government’s regulatory model of export certification is based on the philosophy of partnership between government and industry (Figure 1).

Figure 1. The regulatory model (simplified).

This model reduces the level of direct government intervention, and places the responsibility for systems management and achievement of required outcomes on industry. As such, it achieves greater flexibility and economic control for individual business and allows government to focus its resources on verification, thus reducing the call on public funds.

4.1 Options for export phytosanitary certification

Official assurances may be provided to exports of plant products where an exporter elects to operate one of the following options:

i. End Point Consignment Inspection.

Within this option every export consignment is subjected to phytosanitary inspection prior to export by an IVA to confirm the plant products compliance with the ICPR for the country of destination as nominated by the exporter.

ii. Approved Organisation Programme.

This option formally recognises the approved Organisations system and the competent staff within it as the primary means of ensuring compliance with ICPRs under an IVA regime of system and surveillance audits to verify the Organisation’s system output(s).

Within the latter option, Organisations shall document their system using the HACCP framework, as a means of identifying and managing the risks associated with their method of operating. The HACCP framework is used to identify, control, manage and eliminate or minimise hazards and other risk factors to plant products in compliance with ICPRs.

4.2 System overview, roles and responsibilities

Under the regulatory model Biosecurity New Zealand, Independent Verification Agencies (IVAs) and Organisations have specific roles. The attributes of the system and roles and responsibilities of the participants are shown in Figure 2.

4.2.1 System overview

The certification system operates in compliance with the requirements of international Organisations (e.g. ISPMs). Biosecurity New Zealand has overall accountability for the provision of New Zealand’s export phytosanitary certification.

Service delivery is provided by competent Independent Verification Agencies (IVAs) through a formalised system for the delegation of authority.

The responsibility for management and achievement of required outcomes lies with organisation’s systems. IVAs are engaged by approved Organisations to undertake compliance audits of their organisation’s systems and by exporters operating on end-point consignment inspection.

Figure 2

4.2.2 Biosecurity New Zealand role

Biosecurity New Zealand has the following major roles:

• i. Standard setting;
• ii. Authorisation of IVAs and approval of Organisations;
• iii. Oversight of compliance processes.

4.2.3 Independent Verification Agencies role

The primary role of authorised IVAs, as agents of Biosecurity New Zealand for the delivery of export phytosanitary certification services, includes:

• i. Evaluation, assessment of organisation’s documented systems as a means of determining their fitness for purpose and recommendation for Biosecurity New Zealand’s approval.
• ii. Completion of audits of approved organisation’s systems.
• iii. Verification of certificates and Organisation’s system output(s).
• iv. Completion of end point consignment inspections, pest surveys, pre-clearance and export compliance programmes and supervision of treatments.
• v. Act as the primary contact for Organisations seeking Biosecurity New Zealand approval of their documented systems.
• vi. Reporting to Biosecurity New Zealand on their findings and performance of the export phytosanitary certification system.

4.2.4 Organisation role

The primary role of approved Organisations is to complete specific export certification activities on behalf of Biosecurity New Zealand in accordance with appropriate standards and specifications to meet ICPRs.

4.2.5 Industry role

The Plants Market Access Council (PMAC) and the Forest Products Exports Committee (FPEC) have been consulted during the design and development of this certification system.

Both of these Organisations have the following ongoing roles associated with the implementation of this certification system:

• i. Monitor operational performance of the system;
• ii. Facilitate industry issues resolution;
• iii. Consultation on priority setting for the development ICPRs;
• iv. Facilitate the establishment and co-ordination of any Technical Advisory Group needed to assess the technical elements of an organisation’s phytosanitary risk management programme.

4.3 Structure of and setting standards

The Biosecurity New Zealand export certification system operates to a set of standards containing policies and procedures that set out the roles and responsibilities for participating parties (Figure 3).

• i. Mandatory standards are outcome based and non-prescriptive and take into account the current ISPM requirements.
• ii. Guidelines are advisory and voluntary and suggest general approaches. PMAC and Biosecurity New Zealand have jointly developed the Guideline “Documenting a System to meet Biosecurity New Zealand Export Certification Standard: Organisation Requirements”.
• iii. Biosecurity New Zealand procedures are internal and prescribe how the system will be administered.
• iv. Special compliance programmes are developed jointly between Biosecurity New Zealand and industry sectors to meet specific importing country’s phytosanitary requirements for some commodities.
• v. Registers of phytosanitary activities and documents for Biosecurity New Zealand procedures will be maintained.

The series of standards can be found on the Biosecurity New Zealand websites:

http://www.biosecurity.govt.nz/commercial-exports/forestry-exports/export-certification-standards

http://www.biosecurity.govt.nz/commercial-exports/plant-exports/export-certification-standards

http://www.biosecurity.govt.nz/regs/trans/treat

Figure 3. Biosecurity New Zealand Export Certification Standards

The standards outline the operational specifications within the Biosecurity New Zealand export certification system for the provision of export phytosanitary certification. Independent Verification Agencies (IVAs) and Organisations operate a range of services and activities that reflect the nature of their export certification needs. To account for this range of service and activity options, a series of specifications (referred to as “Technical Requirements”), have been developed for each of these options. These “Technical Requirements” are referenced in the IVA system and organisation system requirements, as appropriate.

• i. Standard: System Overview and Requirements.
  
  This document contains the overview, policies and general requirements for Biosecurity New Zealand Export Certification system (See this standard).
• ii. Standard: Independent Verification Agency Requirements. Requirements to be met by an independent verification agency (IVA) to gain authorisation to undertake import and plant export certification services.
  
  This standard prescribes the system and technical requirements in addition to ISO/IEC 17020:2000 that must be met by an IVA to achieve and maintain authorisation by Biosecurity New Zealand for the provision of import and plant export certification services.
• iii. Standard: Organisation Requirements. Requirements to be met by an organisation to gain approval to undertake export phytosanitary certification activities.
  
  This standard prescribes the system and technical requirements that must be met by an organisation undertaking export phytosanitary certification activities to achieve and maintain approval by Biosecurity New Zealand.
• iv. Standard: Pest Identification Requirements.
  
  This standard prescribes the system and technical requirements that must be met by independent Organisations providing pest identification services. (This standard is not scheduled for revision until 2007).
• v. Technical Requirements: Phytosanitary Inspection.
  
  This standard specifies the minimum technical requirements to be met by IVAs and Organisations undertaking phytosanitary inspection activities.
• vi. Technical Requirements: Treatments.
  
  The minimum technical requirements for Organisations completion of phytosanitary treatments are specified in specific sections of the standards “Treatment Supplier Programme- Overview and General Requirements” and “Requirements for the supplier of official treatments”.
• vii. Technical Requirements: Phytosanitary Documentation (Phyto Ecert).
  
  This standard specifies the minimum technical requirements for the administration of phytosanitary certificate requests, and approval of certificate print locations.
• viii. Technical Requirements: Pest Survey.
  
  This standard specifies the minimum technical requirement to be met by Organisations and IVAs seeking Biosecurity New Zealand approval to undertake survey activities for specific pests to ascertain the pest free status of an area, production site or crop.
• ix. Technical Requirements: Registered Certification Mark (ISPM 15).
  
  This standard specifies the minimum technical requirements to be met by Organisations seeking Biosecurity New Zealand approval to undertake activities associated with the application of a “MAF Registered Mark” to wooden packaging material as per ISPM 15. (Eventually all MAF Marks will be operated from within one standard)
• x. Technical Requirements: Seed Certification.
  
  This standard specifies the minimum technical requirements to be met by seed lines seeking varietal certification.

4.3.1 Identification of importing country phytosanitary requirements (ICPR)

As there are no New Zealand legislative requirements for certification of exported plant products, the technical phytosanitary requirements are determined by the importing country for plant produce being imported into their country. In this respect, ICPRs are Biosecurity New Zealand’s summary of the importing country’s legal requirements, and thus form the primary basis upon which export phytosanitary certification is provided.

Where an importing country operates on the basis of issuing import permits to their importers, the import permit conditions take precedence over any technical conditions contained in the Biosecurity New Zealand ICPR for that country.

Where an importing country’s phytosanitary requirements are unknown, or where the country does not specify any quarantine pests, the optional clause (i.e. “They are deemed to be free from other pests”) will apply.

Note: There is no MPL for seed for sowing.

Under these circumstances the following generic “default” Maximum Pest Limits shall be used for the provision of a phytosanitary certificate:

i. For all plant products excluding logs

≤ 5.0% plant products infested by plant pests and

≤ 25g soil per inspection sample.

ii. For logs

≤5.0% plant products infested by plant pests and

Soil clumps ≤5 mm in thickness and ≤25 mm in diameter.

The review and development of ICPRs by Biosecurity New Zealand will be undertaken in a manner that is science and risk based, with information made available to IVAs and Organisations in a format that allows them to be used as a meaningful decision-making tool.

Biosecurity New Zealand will translate, summarise, review and maintain customised importing countries phytosanitary requirements that are product per country specific (where information is available).

Overarching operating principles for ICPR development and review are:

1. ICPR development and review enables Biosecurity New Zealand to provide an accurate official phytosanitary assurance, facilitating access to offshore markets for New Zealand exporters of horticultural, arable and forestry commodities.
2. Activities associated with ICPR review and development, with the exception of final document verification, may be outsourced by Biosecurity New Zealand.
3. All costs incurred by Biosecurity New Zealand in the development and review of ICPRs will be recovered in accordance with treasury guidelines.
4. Development and review of ICPRs will be undertaken in accordance with the policies and principles identified above and will incorporate feedback from industry Organisations.

The ICPRs can be found on the Biosecurity New Zealand websites:

http://www.biosecurity.govt.nz/regs/exports/plants/icpr

http://www.maf.govt.nz/biosecurity/exports/plants/certification/index.htm

4.3.2 Provision of additional declarations

Frequently an importing country will request specific additional information pertinent to the phytosanitary status of an export consignment’s freedom from specific pests. Where an importing country specifies they require “surveyed, inspected or tested and found free” from any pests, the area of production, or the crop or consignment must be surveyed, inspected or tested as appropriate prior to the specific additional declaration being provided.

Additional declarations are to be provided only where:

• i. There is a validated record of the importing country requesting the information to be stated on a phytosanitary certificate.
• ii. There is evidence that justifies the provision of the additional information being requested by the importing country.

4.3.2.1 Country freedom additional declarations

Country freedom additional declarations may be given only where New Zealand records indicate that the specific pests as specified by the importing country are not recorded within New Zealand.

4.3.2.2 Consignment freedom from specific pest(s) additional declarations

Consignment freedom additional declarations from specific pests may be provided on the following basis:

• i. Where New Zealand pest detection records indicate that the specific pest has not been recorded in New Zealand; or
• ii. Where the pest is known to be present in New Zealand and the crop is a known host, the crop has been surveyed/inspected/tested as appropriate and found free.

4.3.2.3 Deviations from additional declaration statements

Deviations from any given Additional Declaration Statement will only be considered where Biosecurity New Zealand obtains from the importing country’s phytosanitary control authority, confirmation their wording for a specific Additional Declaration may be modified.

4.3.2.4 Duration of area freedom additional declarations

An area freedom clearance following an official survey/test lasts for as long as:

• i. Officially recognised controls ensure there is no reasonable chance of infestation/re-infestation with the pests of concern; or
• ii. For a maximum of one growing season where there are no officially recognised controls that would prevent the introduction of the pest of concern.

The technical justification for this growing season clearance only applies where, following the clearance having been gained, no material is brought onto the production site that could introduce the pest(s) of concern.

If however a production site is cleared and the organisation introduces plants (for planting) and/or soil (on machinery etc.) of unknown health status, the production site will lose its clearance status and another survey/test will be required to regain the pest free status.

4.3.3 Principles of audit frequency

A key process in the export certification system is the use of audits to ensure the system is working effectively and achieving the required outcomes. The following principles underpin the Phytosanitary assurance system.

• 1. Audit frequency should be commensurate with risk:
  • i. Risk associated with the product type;
  • ii. Risk associated with the system performance;
  • iii. Risk mitigation through random versus notified audits;
  • iv. Risk associated with the duration of the export season.
• 2. Audit frequency is designed to encourage Organisations through recognizing systems that deliver a product compliant with importing countries’ requirements.
• 3. An increased number of audits within a specified time period is a consequence of the detection of a critical non-compliance.
• 4. Suspension of an IVA’s authorization or an Organisation’s approval occurs when confidence in their system is lost by Biosecurity New Zealand.
• 5. The purpose of increasing the number of audits within a specified time period is to provide the organisation with the time and opportunity to correct their system whilst maintaining sufficient scrutiny through the increased number of audits to confirm that:
  • i. Product being exported is compliant with the importing countries’ requirements; and
  • ii. The problem has been rectified.

4.4 Requests for post export official assurances

Biosecurity New Zealand will not provide en route or post-arrival inspection and certification of horticultural/arable produce that has not undergone inspection in New Zealand.

Where Biosecurity New Zealand is informed of produce having been exported to a destination for which inspection for compliance with phytosanitary requirements has not been undertaken for that destination, the importing control authorities will be informed. Further, Biosecurity New Zealand will make it clear to the importing control authorities that Biosecurity New Zealand is unable to give any form of assurance as to the pest status of the consignment in question. Any decision as to what action (e.g. re-ship, inspect/accept, destroy) should be undertaken on arrival is solely that of the importing country.

4.5 Biosecurity New Zealand cost recovery fees

Biosecurity New Zealand Exports is required to recover the cost of all work associated with the provision of export certification.

The schedule of fees is available from:

http://www.biosecurity.govt.nz/commercial-exports/plant-exports/fees

APPENDIX 1: REFERENCES

Biosecurity New Zealand standards reference from the following documents:

1. International Plant Protection Convention (IPPC) 1999 and its associated ISPMs
2. Alinorm 95/13 (Annex to Appendix iii) - Guidelines for the Application of the Hazard Analysis Critical Control Point (HACCP) System, Report of the 27th Session of Codex Committee on Food Hygiene (CCFH), October 1994.
3. International Seed testing Association (ISTA) Rules Seed Science and Technology, International Rules for Seed Testing, 1999 volume 27, Supplement, Rules, 1999.
4. Organisation for Economic Co-operation and Development (OECD) Seed Schemes (and all subsequent amendments) for the Varietal Certification of Seed Moving in International Trade:
   • Cereal Seed (1988);
   • Crucifer Seed and Other Oil or Fibre Species Seed;
   • Grass and Legume Seed;
   • Herbage and Oil Seed (1973);
   • Maize and Sorghum Seed (1977);
   • Sugar Beet and Fodder Beet Seed (1970).
5. Biosecurity Act 1993 (as amended by the Biosecurity Amendment Act (1997)
6. Hazardous Substances and New Organisms Act 1997
7. Health Act 1956
8. AS/NZS ISO 8402:1994 - Quality management and quality assurance - Vocabulary.
9. ISO Guide 2:1996 Standardisation and related activities – General vocabulary
10. ISO Guide 28 - General rules for a model third-party Certification system for products.
11. ISO Guide 65: General requirements for operating product certification systems
12. ISO Guide 62 (NZS 3842): 1998 - General requirements for bodies operating assessment and certification/registration of quality systems.
13. AS/NZS ISO 9000: 2000: Quality management systems – Fundamentals and vocabulary
14. AS/NZS ISO 9001:2000; Quality management systems - requirements.
15. AS/NZS ISO/IEC 17020: 2000; General criteria for the operation of various types of bodies performing inspection.
16. AS/NZS ISO/IEC 17025: 2005; General Requirements for the Competence of Testing and Calibration Laboratories.
17. ISO 19011:2003; Guidelines for quality and/or environmental management systems auditing
18. AS/NZS ISO 17011:2004: Conformity assessment – General requirements for accreditation bodies accrediting of conformity assessment bodies (corrected version February 2005)
19. Biosecurity New Zealand Export Certification Standard: IVA Requirements. Requirements to be met by an Independent Verification Agency (IVA) to gain authorisation to undertake import and plant export certification services.
20. Biosecurity New Zealand Export Certification Standard: Requirements for the Authorisation of Independent Plant Pest Identifiers.
21. Biosecurity New Zealand Export Certification Standard: Organisation Requirements. Requirements to be met by Organisation to gain approval to undertake export certification activities.
22. Biosecurity New Zealand Export Certification Standard: Technical Requirements” Phytosanitary Documentation Services (Phyto Ecert).
23. Biosecurity New Zealand Export Certification Standard: Technical Requirements: Phytosanitary Inspection.
24. Biosecurity New Zealand Export Certification Standard: Technical Requirements: Preparation of a Pest List.
25. Biosecurity New Zealand Export Certification Standard: Technical Requirements: Pest Surveys.
26. Biosecurity New Zealand Export Certification Standard: Technical Requirements: Registered Certification Mark (ISPM 15).
27. Biosecurity New Zealand Export Certification System Standard: Technical Requirements: Seed Certification.
28. Biosecurity New Zealand Standard: Requirements for the Supplier of Official Treatments.
29. Biosecurity New Zealand Treatment Supplier Programme: Overview and General Requirements.
30. For seed fumigation: Bowley and Bell, C.H. 1981. “The toxicity of twelve fumigants to three species of mites infesting grain. Journal of Stored Products Research 17(2): 83-87”.

APPENDIX 2 DEFINITIONS

These definitions apply to the export phytosanitary certification system. They have been referenced, where appropriate, from IPPC.

1. Accredited

Having been formally recognised by an international accreditation body as complying with the requirements of an international standard.

2. Additional Declaration

A statement that is required by an importing country to be entered on a phytosanitary certificate and which provides specific additional information pertinent to the phytosanitary condition of a consignment.

3. Approved

An Organisation that has been formally recognised by Biosecurity New Zealand as competent to receive delegated authority to act on his/her behalf to provide specific phytosanitary activities in accordance with the requirements specified in the relevant Biosecurity New Zealand standard(s).

Note: Scope of approval only includes specific phytosanitary activities for which the agency has sought authority to undertake on behalf of Biosecurity New Zealand within the scope of this certification system.

4. Audit

A systematic and independent process for obtaining information and examining it objectively to determine the degree of conformity with prescribed criteria.

4a A System Audit is an evaluation of the Organisation’s entire system for compliance with the certification system’s requirements.

4b A Surveillance Audit is an evaluation of specific parts of the Organisation’s system, to confirm that the outputs of their system meet(s) required specifications.

5. Auditor

A person with the competence to carry out an audit to determine the degree of conformity with prescribed criteria.

6. Authorised

An Independent Verification Agency that has been formally recognised by Biosecurity New Zealand as competent to receive delegated authority to act on his/her behalf to provide a specific phytosanitary service(s) in accordance with the requirements specified in the relevant Biosecurity New Zealand standard(s).

Note: Scope of authorisation only includes specific phytosanitary activities for which the agency has sought authority to undertake on behalf of Biosecurity New Zealand within the scope of this certification system.

7. Biosecurity New Zealand

Biosecurity New Zealand is the body within MAF that is responsible for biosecurity functions, providing official assurances to control authorities in importing countries through export certification.

8. Certificate

An official document which attests to the status of any consignment affected by regulations.

9. Certification

All those activities leading to, but not including, the issuance of Certificates.

10. Competence

Demonstrated ability to apply knowledge and skills.

11. Commodity Pest list

A list of all pests recorded in New Zealand associated with the commodity to be exported.

12. Consignment

A quantity of plants, plant products or other articles being moved from one country to another and covered, when required, by a single Certificate (a consignment may be composed of one or more lots).

13. Contract of “Delegated Authority”

A document forming part of this certification system’s standards which sets out the legally binding arrangement entered into by Biosecurity New Zealand and an IVA and/or an organisation to formalise the delegation of authority to act on Biosecurity New Zealand’s behalf to provide a specific phytosanitary service(s) in accordance with the requirements specified in the relevant Biosecurity New Zealand standard(s).

14. Control Point

A point or step in a phytosanitary risk management system (e.g. harvest, grading, packing, storage, handling, transport or preparation of export documents) where specific procedures can be applied to achieve a defined effect and can be measured, monitored, controlled and corrected.

Note: The abbreviation CCP is used when referencing a critical control point.

15. Corrective Action Request (CAR)

Action request raised by an auditor requesting corrective action for non-compliance findings with prescribed standards.

16. Critical Limit

A value that separates acceptability from unacceptability.

17. Declaration of Conformity

Statement by an organisation that plant product conforms to the phytosanitary requirements of an importing country.

18. Devitalisation

A procedure rendering plant products incapable of germination, growth or further reproduction.

19. Director

The Director, Pre-clearance, Biosecurity New Zealand, of the New Zealand Ministry of Agriculture and Forestry (MAF) and is appointed as a Chief Technical Officer under section 101 of the Biosecurity Act 1993 or delegate.

20. End Point Consignment Inspection

An officially recognised phytosanitary inspection process for plant product at a final point of storage prior to loading for export.

21. Equivalence

Phytosanitary and/or genetic purity measures which are not identical but have the same effect.

22. Event Reports

A written report submitted to Biosecurity New Zealand by an Independent Verification Agency in response to specific situations defined in the standard being followed.

23. Hazard

The potential to cause harm. Types of hazards can be divided into biological, chemical or physical.

24. HACCP

Abbreviation for Hazard Analysis and Critical Control Point, which is a system that identifies, evaluates and controls hazard(s) that are significant, and the preventative measures for their control.

25. Homogenous Lot

A defined volume of plant product subject to the same pest management regime that has been produced within a pre-determined production area, where the defective units within the lot occur independently of each other and the fraction of defective plant product is constant throughout the lot.

26. ICPR

Importing Countries Phytosanitary Requirements, available at:

http;//www.biosecurity.govt.nz/regs/exports/plants/icpr

27. Independent

Not having a commercial interest in the operation and not depending on another body for its validity.

28. Independent Verification Agency (IVA)

An organisation accredited as meeting ISO/IEC 17020:2000 and its independence criteria type A, and Biosecurity New Zealand supplementary technical requirements, and authorised by Biosecurity New Zealand to carry out services associated with export certification.

29. Inspection

An official visual examination of plant products or other regulated articles to determine compliance with regulations. For phytosanitary regulations inspection is to determine if pests are present.

30. Inspector

A person authorised by Biosecurity New Zealand to carry out inspection activities.

31. Interception

The detection of a pest during inspection or testing of an imported consignment that may result in the refusal or controlled entry of the consignment because of failure to comply with phytosanitary regulations.

32. IPPC

Abbreviation for International Plant Protection Convention.

33. ISPM

Abbreviation for International Standard for Phytosanitary Measures.

34. Location

An operational site, within a Biosecurity New Zealand approved Organisation’s system, where phytosanitary activities are undertaken, or reference documents, or records, or fixed equipment are kept, or if the phytosanitary activity involves a mobile facility then that mobile facility.

35. MAF

Abbreviation for NZ Ministry of Agriculture and Forestry.

36. Mark

An official stamp or brand, internationally recognised, applied to a regulated article to attest to its phytosanitary status.

37. MPL

Abbreviation for Maximum Pest Limit, which is the maximum percentage of plants or plant products infested with pests acceptable within each lot inspected, as determined by the importing country or the current information available to Biosecurity New Zealand at the time.

38. National Plant Protection Organisation (NPPO)

Official service established by the government to discharge the functions specified by the International Plant Protection Convention (IPPC). In New Zealand MAF is the NPPO.

39. Non-compliance

Failure to comply with requirements specified in the relevant standards, or specifications.

40. Official

Established, authorised or performed by Biosecurity New Zealand.

41. Official treatments

Official treatments are those required by Biosecurity New Zealand for import risk goods and for export goods to comply with Import Countries Phytosanitary Requirements (ICPRs).

42. Organisation

The legal entity, be it an individual, partnership, company or other form of legal entity, responsible for the performance of the phytosanitary risk management system approved by Biosecurity New Zealand.

43. Organisation’s System

The organisational structure, responsibilities, operational procedures, processes and resources for implementing activities associated with phytosanitary inspections, audits, or the preparation of export documents for the provision of Biosecurity New Zealand export phytosanitary certification.

44. Organism

As defined by the Biosecurity Act (1993) (as amended by the Biosecurity Amendment Act (1997) and for the purposes of this standard:

a) Does not include a human being or a genetic structure derived from a human being;

b) Includes a micro-organism;

c) Subject to paragraph (a) of this definition, includes a genetic structure that is capable of replicating itself (whether that structure comprises all or only part of an entity, and whether it comprises all or only part of the total genetic structure of an entity);

d) Includes an entity (other than a human being) declared by the Governor-General by Order in Council to be an Organism for the purposes of this Act;

e) Includes a reproductive cell or developmental stage of an Organism;

f) Includes any particle that is a prion.

45. Output

This is defined as the result of the certification system activity, which may be a plant product, request for certification or record of activity, linked to the plant product.

46. Pathway

Any means that allows the entry or spread of a pest.

47. Pest

Any species, strain or biotype of plant, animal, or pathogenic agent, injurious to plants, plant products or animals.

48. Pest Categorisation

The process for determining whether a pest has, or has not, the characteristics of a quarantine pest or those of a regulated non-quarantine pest.

49. Pest Free Area

An area in which a specific pest does not occur as demonstrated by scientific evidence and in which, where appropriate, this condition is being officially maintained.

50. Pest Free Place of Production

Place of production in which a specific pest does not occur as demonstrated by scientific evidence and in which, where appropriate, this condition is being officially maintained for a defined period.

51. Pest Free Production Site

A defined portion of a place of production in which a specific pest does not occur as demonstrated by scientific evidence and in which, where appropriate, this condition is being officially maintained for a defined period and that is managed as a separate unit in the same way as a pest free place of production.

52. Pest Record

A document providing information concerning the presence or absence of a specific pest at a particular location at a certain time, within an area (usually a country) under described circumstances.

53. Phytosanitary Certificate

Certificate patterned after the model certificates of the International Plant Protection Convention (IPPC).

54. Phytosanitary Certification

Use of phytosanitary procedures leading to the issue of a phytosanitary certificate.

55. Phytosanitary Procedure or Activity

Any officially prescribed method for implementing phytosanitary regulations including the performance of inspections, tests, surveillance or treatments in connection with regulated pests.

56. Plant Products

Any material of plant origin.

57. Plant Pest Identifier

A person with specialist knowledge undertaking pest identification in one or more of the scientific disciplines of entomology, mycology, bacteriology, nematology, virology.

58. Pre-clearance

Phytosanitary certification and/or clearance in the country of origin, performed by or under the regular supervision of the NPPO of the country of destination.

59. Procedure

A document that specifies the purpose and scope of an activity; what shall be done and by whom; when, where, and how it shall be done; what materials, equipment, and documentation shall be used; and how it shall be controlled and recorded.

60. Quality Management System

A set of interrelated or interacting elements (procedures and/or processes) within an organisation to establish policy and objectives and to achieve those objectives, used to direct and control an organisation with regard to fulfilling requirements.

61. Quarantine Pest

A pest of potential economic importance to the area endangered thereby and not yet present there, or present but not widely distributed and (is) being officially controlled.

62. Recognised Individual

An individual within a Biosecurity New Zealand authorised IVA or approved organisation who is recognised by Biosecurity New Zealand as competent, by way of their staff competency assessment process, to act on Biosecurity New Zealand’s behalf to provide export phytosanitary services and activities in accordance with the requirements specified in the relevant Biosecurity New Zealand standards.

63. Registration Fee

A fee, payable by the appropriate organisation, that contributes to the Biosecurity New Zealand management costs associated with export certification.

64. Regulated Article

Any plant, plant product, storage place, packaging, conveyance, container, soil and any other organism, object or material capable of harbouring or spreading pests, deemed to require phytosanitary measures, particularly where international transportation is involved.

65. Regulated Pest

A quarantine pest or a regulated non-quarantine pest.

66. Risk Goods

Means any organism, organic material, or other thing, or substance, that (by reason of its nature, origin, or other relevant factors) it is reasonable to suspect constitutes, harbours or contains an organism that may cause unwanted harm to natural and physical resources or human health in New Zealand; or interfere with the diagnosis, management, or treatment, in New Zealand of Pests or unwanted organisms.

67. Sample

One or more units selected from a population of units, or a portion of material selected from a larger quantity of material.

68. Seed Categories

For the purposes of seed variety trueness to type certification in New Zealand, the following seed certification categories apply:

i. “Breeders seed”

Seed produced from nucleus material grown by the plant breeder.

Note: within the OECD Seed Schemes this category of seed is known as "Pre-basic seed" (i.e. any generation of seed between parent material and 'Basic' seed under the responsibility of the breeder).

ii. "Basic seed”

Seed produced from plants sown with Breeder’s seed (i.e. the seed is produced by selected growers under the supervision of the breeder or their agent).

iii. “Certified Seed 1st Generation”

Seed derived from areas sown with Basic seed.

iv. “Certified Seed 2nd Generation”

Seed derived from areas sown with Certified Seed 1st Generation.

v. “Commercial (uncertified) Seed”

Seed line that has either failed the New Zealand seed certification scheme, or has not been part of this certification scheme.

69. Specification

Part of a document that prescribes a specific requirement with which the product or service has to conform.

70. Standard

Document established by consensus and approved by a recognised body, that provides, for a common and repeated use, rules, guidelines or characteristics for activities or their results aimed at the achievement of the optimum degree of order in a given context.

71. Supervision

Oversee, through direct observation, pre-determined activities being undertaken by another party, to confirm compliance with specifications and/or procedures.

72. Supplier

Means the party (either an authorised IVA or an approved organisation) responsible for the performance of specific export certification activities on behalf of Biosecurity New Zealand.

73. Surveillance

An official process that collects and records data on pest occurrence or absence by survey, monitoring or other procedures.

74. Survey

An official procedure conducted over a defined period of time to determine the characteristics of a pest population or to determine which species occur in an area.

75. Systems Approach(es)

The integration of different pest management measures, at least two of which act independently, and which cumulatively achieve the appropriate level of phytosanitary protection.

76. Test

Official examination, other than visual, to determine if pests are present or to identify pests.

77. Treatment

Officially authorised procedure, for the killing or removal or rendering pests infertile.

Note: For the purposes of this certification system, treatment also includes rendering the pests and/or plant products non-viable or devitalising a consignment of plant products.

78. Treatment Supplier (Refer organisation)

79. Treatment Technician

A person familiar with the treatment methods and procedures, the objectives of the treatment and the audit of the treatment results but operate under effective oversight by the treatment supplier.

80. Treatment Certificate

A uniquely numbered certificate issued by a treatment supplier verifying that an approved treatment has been completed in accordance with this Standard and includes a description of the treatment.

81. Unit

The smallest discrete portion in a lot, which will be withdrawn to form the whole or part of a sample.

Units are identified as follows:

i. Fresh fruits and vegetables: Each whole fruit (e.g. an apple, a blueberry), vegetable (e.g. an asparagus spear, onion, potato tuber) or natural bunch (e.g. grapes, red currants), will form a unit. Individual fresh fruit or vegetables must not be cut or broken to produce units.

ii. Flowers and foliage: A stem is regarded as a unit except in the case of orchids where a bloom is the unit.

iii. Nursery stock: The individual plant/cutting is the unit. The individual plants must not be cut to produce units.

iv. Grain, seeds and grain products: The individual unit is that which is created with a sampling device.

v. Sphagnum moss, bark chips and inert material: The individual unit is that which is created when obtained with a sampling device.

82. Verification

Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

Page last updated: 13 June 2008