1. IPPC first consultation 1 July to 30 September 2018
DRAFT ISPM: Authorization of entities to perform phytosanitary actions ( )
IPPC first consultation
1 July to 30 September 2018
IPPC Secretariat
2018 IPPC Regional Workshop

2. Major Stages SC May 2016 EWG 2017 SC May 2018 Call for topics 2013
Topic submitted: Authorization of non-NPPO entities to perform phytosanitary actions
SC Nov 2013
Recommended adding to List of Topics
CPM-9 (2014)
Added to List of Topics with priority 3 (CPM-10 upgraded to priority 2)
SC May 2016
Approved Specification 65: Authorization of entities to perform phytosanitary actions.
EWG 2017
Draft ISPM
SC May 2018
Approval of the draft ISPM for first consultation period

3. General Considerations
Reason for the ISPM
It is becoming common in various countries for national plant protection organizations (NPPO) to authorize entities to perform specific phytosanitary actions.
There is a need to ensure the criteria for such authorizations are harmonized and that the practice aligns with the principles of the IPPC.
Authorization of entities other than national plant protection organizations (NPPOs) to perform specific phytosanitary actions such as inspection, testing, surveillance and treatment is becoming common in various countries throughout the world to enhance cost-effectiveness and efficiency. The need for international harmonization when considering, developing and implementing authorization programmes has led to the development of this standard.
ISPM provides a framework that enables NPPOs to authorize private entities to perform specific phytosanitary actions associated with import, export and domestic systems on behalf of the NPPO.

4. Clarification of “entities”
Major drafting issues
NPPOs authorize many different types of entities and therefore more details are provided to clarify.
Clarification of “entities”
In this standard “entities” include the providers of phytosanitary action (e.g. individuals, organizations, businesses) and, where appropriate, their facilities (such as equipment, laboratories, treatment enclosures).
In some cases, authorization of entities may require an NPPO to approve individuals within the entity (such as those responsible for specific phytosanitary actions), relevant documentation, their facilities, or any combination of these.
SC report: The SC noted that NPPOs authorize many different types of entities and there are many different arrangements. The SC therefore provided more details, clarifying that authorization of entities includes providers of phytosanitary actions (for example individuals, organizations, businesses) and, where appropriate, their facilities (such as equipment, laboratories, treatment enclosures). The SC agreed that in some cases authorization of entities may require approval of individuals in the entity, relevant documentation, and facilities.

5. Private vs public entities
Major drafting issues
Draft clarifies that NPPOs should use the standard for authorization of private entities and may use some elements of this standard when involving public entities.
Private vs public entities
Differences exist between authorizing governmental bodies, for example Customs, and authorizing private entities such as laboratories.
Arrangements for authorization depend on the situation in a country and it would be difficult to cover all possibilities in an ISPM.
NPPO to decide how the authorization is undertaken and which entities should be covered by the requirements of the standard.
SC report: Some SC members recognized that the NPPO may authorize other government departments to perform phytosanitary actions and it may be inappropriate to require them to comply with all parts of the standard. The SC therefore clarified that NPPOs should use the standard for authorization of private entities and NPPOs may use elements of this standard when authorizing public entities. The SC agreed that if NPPOs authorize other government/public entities, they will determine the nature of the authorization arrangement.

6. Development of Authorization Programme
Major drafting issues
NPPO should define its objectives for, and develop, an authorization programme that is appropriate for its purposes.
Development of Authorization Programme
Authorization requires an “initiation and approval process”.
To address the concern that NPPOs may not have the skills to perform a phytosanitary action and may use an entity, the text states that it should be “at least equivalent to those required for the NPPO personnel”.
NPPO should develop a contingency plan to ensure business continuity in the event that an authorized entity no longer undertakes the phytosanitary actions.

7. Criteria for eligibility of entities
Major drafting issues
NPPOs should ensure that the entity meets the criteria prior to being authorized to perform phytosanitary actions.
Criteria for eligibility of entities
The draft indicates that an entity should submit to the NPPO its documented quality management system, this including a documented quality manual and standard operating procedures, unless other documentation is deemed sufficient by the NPPO.
Conflict of interest: it is clarified that an entity should declare the conflicts of interest and identify how they would be managed. NPPOs may not authorize if conflict of interest is unacceptable.
SC report: Conflicts of interest. The SC noted that in many countries there is a requirement that there are no conflicts of interest. However, there may be cases where there are conflicts of interest. In such cases, the entities should declare the conflicts of interest and identify how they would be managed. The SC noted that NPPOs are not obliged to authorize entities if they consider the conflicts are unacceptable. In all cases, the entity should act impartially when undertaking authorized activities.

8. Roles and responsibilities
Major drafting issues
Clarified the roles and responsibilities of NPPOs and authorized entities during the implementation of the authorization programme.
Roles and responsibilities
Authorization of entities to undertake audits:
The SC noted that the requirements for authorization of entities to undertake audits or supervision were different to authorizations of entities for other phytosanitary actions.
A separate section was created to include all the requirements for entities that are authorized to audit or supervise, including the criteria for eligibility and roles and responsibilities.
SC report: Roles and responsibilities of the NPPO. The SC deleted a requirement to promote, clarify and demonstrate the benefits of becoming authorized because these are beyond the scope of the standard. It was noted that these might be considered in a manual on authorization.
Authorization of entities to undertake audits. The SC noted that the requirements for authorization of entities to undertake audits or supervision were different to authorizations of entities for other phytosanitary actions. The SC therefore created a separate section to include all the requirements for entities that are authorized to audit or supervise, including the criteria for eligibility and roles and responsibilities.

9. Major drafting issues
Reduced detail on requirements for audits to authorize an entity and to maintain authorization in view of future ISPM on audits.
Audits
The section on Audits was simplified because the SC noted that Audit in the phytosanitary context ( ) is on the List of topics for IPPC standards and this draft should not be in conflict with or duplicate the future ISPM.
Audits should be conducted prior to the authorization of an entity and audits of the entity’s whole system should be conducted at least once a year to maintain authorization. Additional audits may be conducted as necessary.

10. Nonconformities and status of authorization
Major drafting issues
Clarified the type and number of nonconformities identified that should be used by the NPPO to determine the authorization status of the entity.
Nonconformities and status of authorization
The type and number of nonconformities identified should be used by the NPPO to determine the ongoing status of the entity (authorized, suspended or revoked) and the subsequent audit frequency.
Nonconformities may be classified as critical nonconformities or other nonconformities.

11. Potential Implementation Issues
NPPOs may need to set up or adjust their legal framework to support the authorization of entities.
Capacity development material on quality systems, quality manuals and on auditing authorized entities would be particularly important to help enhance NPPOs’ ability to proficiently carry out authorization of entities.
Some NPPOs may perceive authorization of entities as being difficult to implement because of potential resistance from NPPO personnel if their tasks and responsibilities are outsourced. Education and confidence building actions may therefore be needed.
Other??

12. Contacts IPPC Secretariat
Food and Agriculture Organization of the United Nations
Viale delle Terme di Caracalla, Rome, Italy
Tel.:
Websites: