If a type of plants for planting is a host of a quarantine pest or pests, APHIS may require the type of plants for planting to be produced in accordance with integrated pest risk management measures as a condition of importation. This section sets out a general framework for integrated pest risk management measures. When APHIS determines that integrated measures are necessary to mitigate risk, APHIS will use this framework to develop integrated pest risk management measures that mitigate the quarantine pest risks associated with that type of plants for planting through the process described in §319.37-20.

(a) Responsibilities of the place of production. The place of production is responsible for identifying, developing, and implementing procedures that meet the requirements of both the NPPO of the exporting country and APHIS. Participants in the export program must be approved by the NPPO or its designee and APHIS. Approval will be conferred by the NPPO or its designee and APHIS after the participant meets the conditions required for integrated pest risk management. Approval will be withdrawn if the participant fails to meet the conditions at any time. All documentation required under paragraphs (a)(5) and (6) of this section will be maintained by the exporting place of production and made available to official representatives of the NPPO of the exporting country and APHIS upon request. The place of production must be open to necessary and reasonable audit, monitoring, and evaluation of compliance by the NPPO of the exporting country and APHIS. The management of the place of production will be responsible for complying with the integrated pest risk management measures. Management must specify the roles and responsibilities of its personnel to perform program activities. The place of production must notify the NPPO of the exporting country of deficiencies detected during internal audits. The NPPO of the exporting country will be responsible for ensuring that the place of production is in compliance with the integrated pest risk management measures.

(1) Pest management program. The place of production must develop and implement an approved pest management program that contains ongoing pest monitoring and procedures for the exclusion and control of plant pests. The place of production must obtain material used to produce plants for planting from sources that are free of quarantine pests and that are approved by the NPPO of the exporting country and APHIS. All sources of plants for planting and the phytosanitary status of those plants must be well-documented and the program for producing plants for planting carefully monitored.

(2) Training. A training program approved by the NPPO of the exporting country and APHIS must be established, documented, and regularly conducted at the place of production. The training program must ensure that all those involved in the export program possess specific knowledge related to the relevant components of the program and a general understanding of its requirements.

(3) Internal audits. The place of production must perform, or designate parties to perform internal audits that ensure that a plan approved and documented by APHIS and the NPPO of the exporting country is being followed and is achieving the appropriate level of pest management.

(4) Traceability. The place of production must implement a procedure approved by APHIS and the NPPO of the exporting country or its designee that documents and identifies plants from propagation through harvest and sale to ensure that plants can be traced forward and back from the place of production. Depending on the nature of the quarantine pests, the system may need to account for:

(i) The origin and pest status of mother stock;

(ii) The year of propagation and the place of production of all plant parts that make up the plants for planting intended for export;

(iii) Geographic location of the place of production;

(iv) Location of plants for planting within the place of production;

(v) The plant taxon; and

(vi) The purchaser's identity.

(5) Documentation of program procedures. The place of production must develop a manual approved by the NPPO of the exporting country and APHIS that guides the place of production's operation and that includes the following components:

(i) Administrative procedures (including roles and responsibilities and training procedures);

(ii) Pest management plan;

(iii) Place of production internal audit procedures;

(iv) Management of noncompliant product or procedures;

(v) Traceability procedures; and

(vi) Recordkeeping systems.

(6) Records. A place of production must maintain records on its premises as specified by APHIS and the NPPO of the exporting country. These records must be made available to APHIS and the NPPO of the exporting country upon request. These documents include all the elements described in this paragraph (a) and copies of all internal and external audit documents and reports.

(b) Responsibilities of APHIS and the NPPO of the exporting country. APHIS and the NPPO of the exporting country are responsible for collaborating to establish program requirements, including workplans and compliance agreements as necessary, for recognizing and implementing particular import programs. Technically justified modifications to the program may be negotiated. The administration of program requirements must include such elements as clarification of terminology, testing and retesting requirements, eligibility, the nomenclature of certification levels, horticultural management, isolation and sanitation requirements, inspection, documentation, identification and labeling, quality assurance, noncompliance and remedial measures, and postentry quarantine requirements. The criteria for approving, suspending, removing, and reinstating approval for a particular program should be jointly developed and agreed upon by APHIS and the NPPO of the exporting country. Information should be exchanged between APHIS and the NPPO of the exporting country through officially designated points of contact.

(c) Responsibilities of the NPPO of the exporting country.

(1) The NPPO of the exporting country must provide sufficient information to APHIS to support the evaluation and acceptance of export programs. This may include:

(i) Specific identification of the commodity, place of production, and expected volume and frequency of consignments;

(ii) Relevant production, harvest, packing, handling, and transport details;

(iii) Pests associated with the plant including prevalence, distribution, and damage potential;

(iv) Risk management measures proposed for a pest management program; and

(v) Relevant efficacy data.

(2) A phytosanitary certificate should be issued by the NPPO of the exporting country unless APHIS and the NPPO of the exporting country agree to use other documentation in accordance with §319.37-6(c).

(3) Other responsibilities of the NPPO of the exporting country include:

(i) Establishing and maintaining compliance agreements as necessary;

(ii) Oversight and enforcement of program provisions;

(iii) Arrangements for monitoring and audit; and

(iv) Maintaining appropriate records.

(d) Responsibilities of plant brokers trading in plants for planting produced in accordance with integrated pest risk management measures. Plant brokers trading in plants for planting produced in accordance with integrated pest risk management measures must be approved by the NPPO of the exporting country or its designee. The list of plant brokers must be provided to APHIS upon request. Approval may only be conferred by the NPPO or its designee after the participant demonstrates that it can meet the requirements of this paragraph (d). Approval must be withdrawn if the participant fails to meet the conditions at any time. Plant brokers must ensure the traceability of export consignments to an approved place of production or production site. Brokers must maintain the phytosanitary status of the plants equivalent to an approved place of production from purchase, storage, and transportation to the export destination. Plant brokers must document these processes for verifying status and maintaining traceability.

(e) External audits. APHIS and the NPPO of the exporting country will agree to the requirements for external audits.

(1) APHIS audits. APHIS will evaluate the integrated pest risk management measures of the NPPO of the exporting country before acceptance. This could consist of documentation review, site visits, and inspection and testing of plants produced under the system. Following approval, APHIS or its designee will monitor and periodically audit the system to ensure that it continues to meet the stated objectives. Audits will include inspection of imported plants for planting, site visits, and review of the integrated pest risk management measures and internal audit processes of the place of production and the NPPO of the exporting country.

(2) Audits by the NPPO of the exporting country. The NPPO must arrange for audits of the exporting system. Audits may be conducted by the NPPO or its designee and may consist of inspection and testing of plants for planting and the documentation and management practices as they relate to the program. Audits should verify that:

(i) The places of production in the program are free of quarantine pests;

(ii) Program participants are complying with the specified standards;

(iii) The integrated pest management measures continue to meet APHIS requirements; and

(iv) Arrangements with designees are complied with.

(f) Noncompliance.

(1) The exporting NPPO must notify APHIS of noncompliance within the integrity of the system or noncompliance by a place of production that affects the phytosanitary integrity of the commodity. The requirements for notification will be determined between the NPPO of the exporting country and APHIS.

(2) Regulatory responses to program failures will be based on existing bilateral agreements. Contingency plans may be established in advance to ensure that alternative measures are available in the event that all or part of a program fails. APHIS will specify the consequences of noncompliance to the NPPO of the exporting country. The NPPO must specify the consequences of noncompliance to the participants in the program. These may vary depending on the nature and severity of the infraction. In addition, remedial measures should be specified to enable a suspended or decertified place of production or plant broker to become eligible for reinstatement or recertification.

(3) Places of production or plant brokers that do not meet the conditions of the program must be suspended. Plants for planting must not be exported from a place of production or a plant broker that has failed to meet the program requirements.

(4) The effectiveness of remedial measures taken must be verified before reinstatement to the program by the exporting NPPO and, where appropriate, by APHIS.

(Approved by the Office of Management and Budget under control number 0579-0190)