ReFreSH

Regulatory Framework for Seed Health

Accreditation Standard / March 8, 2021

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Table of Contents

Contents

Scope....................................................................................................................................... 1

References............................................................................................................................... 2

Definitions............................................................................................................................... 3

1. GENERAL REQUIREMENTS................................................................................................ 6

1.1. U.S. Legislative Authority. ........................................................................................... 6

1.2. Eligible Commodities.. ................................................................................................ 6

1.3. Eligible Entities.. ......................................................................................................... 6

1.4. Fees. ........................................................................................................................... 6

2. APPLICATION AND ENROLLMENT IN THE REFRESH PROGRAM ......................................... 7

2.1. Application. ............................................................................................................... 7

2.2. Accreditation audit.................................................................................................... 7

2.3. Enrollment................................................................................................................. 7

3. NPPO RESPONSIBILITIES................................................................................................... 7

3.1. ReFreSH authorizing NPPO ........................................................................................ 7

3.1.1. Program administration.. ....................................................................................... 7

3.1.2. Program review...................................................................................................... 7

3.1.3. Program Enrollment............................................................................................... 7

3.1.4. Registration............................................................................................................ 8

3.1.5. Records. ................................................................................................................. 8

3.1.6. Audits..................................................................................................................... 8

3.1.7. Suspension/reinstatement of entity....................................................................... 9

3.1.8. Accreditation. ....................................................................................................... 9

3.2. Importing country NPPO............................................................................................ 9

3.2.1. Import requirements. ........................................................................................... 9

3.2.2. Review ................................................................................................................... 9

3.2.3. Monitoring ............................................................................................................. 9

3.2.4. Notification of non-compliance ............................................................................ 10
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4. NON-CONFORMANCE AND CORRECTIVE MEASURES...................................................... 10

4.1. Types of Non-conformance ......................................................................................... 10

4.1.1. Critical non-conformances.................................................................................... 10

4.1.2. Minor non-conformances..................................................................................... 10

4.2. Non-conformance detection and determination of status .......................................... 10

4.3. Detection by authorizing NPPO................................................................................... 10

4.4. Detection by the entity ............................................................................................... 10

4.5. Detection by the importing country NPPO. ................................................................. 10

4.6. Corrective action requests. ......................................................................................... 11

4.7. Suspension of accreditation ........................................................................................ 11

4.8. Reinstatement of suspended entities.......................................................................... 11

4.9. Cancellation of the ReFreSH Agreement ..................................................................... 12

5. REFRESH PARTICIPATING ENTITY RESPONSIBILITIES....................................................... 12

5.1. ReFreSH Manual ......................................................................................................... 12

5.1.1. Staff and Facility................................................................................................... 13

5.1.2. Seed Health Management Plan......................................................................... 13

5.1.3. Identification and tracking................................................................................ 14

5.1.4. Internal Audits and System Improvement......................................................... 14

5.1.5. Records and Documents....................................................................................... 14

5.1.6. Reporting and monitoring.. .................................................................................. 15

APPENDIX: EXAMPLES OF NON-CONFORMANCE ................................................................... 16
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Scope

This Standard describes the essential elements of the Regulatory Framework for Seed Health

(ReFreSH), a risk-based systems approach alternative to individual consignment inspection as

the basis for phytosanitary certification for the international movement of seed, including its

importation into the United States. ISPM 38 recognizes that certain seed production practices

when used in combination may be sufficient to reduce or prevent pest introductions and

distributions through the seed supply chain. ReFreSH combines elements of these seed

production best management practices, phytosanitary systems approach and quality

management systems. ReFreSH is a voluntary program conducted under the authority of

national plant protection organizations (NPPOs) that accept it as a valid system for

phytosanitary certification of seed moving internationally. The ReFreSH Standard outlines the

basic requirements for a seed entity implementing ReFreSH and the responsibilities of NPPOs

accepting the ReFreSH Program. 
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References

• Agreement on the Application of Sanitary and Phytosanitary Measures. 1994. World

Trade Organization, Geneva, Switzerland.

https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm.

• International Rules for Seed Testing 2020. 2020. The International Seed Testing

Association (ISTA), Bassersdorf, Switzerland. https://www.seedtest.org/en/Rules/freerules-chapters-_content---1--3410.html.

• International Standards for Phytosanitary Measures (ISPM) 5 Glossary of Phytosanitary

Terms. 2018. FAO, Rome. https://www.ippc.int/en/core-activities/standardssetting/ispms/.

• International Standards for Phytosanitary Measures (ISPM) 11 Pest risk analysis for

quarantine pests. 2017. FAO, Rome. https://www.ippc.int/en/core-activities/standardssetting/ispms/.

• International Standards for Phytosanitary Measures (ISPM) 12 Phytosanitary

Certificates. 2017. FAO, Rome. https://www.ippc.int/en/core-activities/standardssetting/ispms/.

• International Standards for Phytosanitary Measures (ISPM) 14 Use of integrated

measures in a systems approach. 2017. FAO, Rome. https://www.ippc.int/en/coreactivities/standards-setting/ispms/ .

• International Standards for Phytosanitary Measures (ISPM) 31 Methods for sampling

consignments. 2016. FAO, Rome. https://www.ippc.int/en/core-activities/standardssetting/ispms/.

• International Standards for Phytosanitary Measures (ISPM) 38 International movement

of seeds. 2018. FAO, Rome. https://www.ippc.int/en/core-activities/standardssetting/ispms/.

• ReFreSH- A Regulatory Framework for Seed Health. Concept Paper. 2019. USDA, APHIS.

Riverdale, MD. https://www.betterseed.org/wp-content/uploads/ReFreSH-ConceptPaper-Draft_-2019.pdf

• Regional Standards for Phytosanitary Measures (RSPM) 28 Authorization of Entities to

Perform Phytosanitary Services. 2014. NAPPO, Raleigh, NC. 

http://www.nappo.org/files/4914/5091/6495/RSPM282-03-15-e.pdf
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• Regional Standards for Phytosanitary Measures (RSPM) 40 Principles of Pest Risk

Management for the Import of Commodities. 2014. NAPPO, Raleigh, NC.

http://www.nappo.org/english/products/regional-standards.

• Systems Approach for Nursery Certification (SANC). 2020. National Plant Board.

https://sanc.nationalplantboard.org/

• Technical Requirements. United States – Canada Greenhouse-Grown Plant Certification

Program (GCP). 2016. USDA, APHIS/Canadian Food Inspection Agency. 

https://www.aphis.usda.gov/plant_health/acns/downloads/2016-gcp-technicalrequirement-mou.pdf

Definitions

The definitions listed here have been taken directly from the references identified in

parentheses, adapted for ReFreSH from those references, or, where no reference is cited,

they have been developed for the purpose of this standard.

Accreditation audit- The accreditation audit is a specific type of systems audit (see Systems

audit) that is conducted after a facility’s ReFreSH application package has been reviewed

and accepted by the authorizing NPPO and prior to enrollment in ReFreSH. The purpose of

the accreditation audit is to demonstrate that all components of the ReFreSH Standard have

been implemented at the entity. Any non-compliance identified during the accreditation

audit must be resolved before the NPPO signs the ReFreSH compliance agreement with the

entity. (GCP)

Audit- Systematic, independent and documented process for obtaining evidence to

objectively evaluate that the requirements of the ReFreSH Standard are met.

Best management practices (BMPs) - A combination of seed supply system practices that

facilitate seed quality and can be an effective and practicable means to prevent, eliminate

or reduce the likelihood of pest introduction or spread to an acceptable level of

phytosanitary protection.

Brokers- Entities that purchase or take possession of seeds from an approved ReFreSH

entity for the purpose of exporting those seeds without further growing prior to export/reexport/sale. (RSPM 24)

Critical control point (CCP) – The identified points, steps or procedures in a process where

controls can be applied and a phytosanitary hazard prevented, eliminated or reduced to an

acceptable level. (ReFreSH Concept Paper)
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Entity- The facility, organization, party or producer responsible for given processes and

practices in the ReFreSH program. (RSPM 41)

Hazard- Any part or process of the seed supply system that has the potential to introduce

plant pests through contamination or infection or allows the entry or spread of a pest.

(ReFreSH Concept Paper)

Infestation (of a commodity) – Presence, in a commodity, of a living pest of the plant or

plant product concerned. Infestation includes infection. (ISPM 5)

Internal audit- An entity activity to monitor and analyze its seed supply system in order to

determine how well it conforms to the procedures described in the entity’s ReFreSH Manual

to meet requirements of the ReFreSH Standard (see Audit).

Non-compliance- Failure to meet official phytosanitary requirements of an importing or

exporting country NPPO.

Non-conformance- Any failure of the entity to follow the agreed upon requirements in their

ReFreSH Manual. Non-conformances are categorized by severity:

Critical non-conformance- Critical non-conformances are incidents that compromise the

integrity and efficacy of an entity’s ReFreSH processes and procedures or increase the

risk of infestation of the seed supply system. (See examples in APPENDIX).

Non-critical non-conformance. Minor non-conformances are incidents that on their

own do not directly impact the integrity of an entity’s ReFreSH processes and

procedures, provided that remedial actions are completed within an agreed upon period

of time defined by the NPPO. (See examples in APPENDIX).

Pest- Any species, strain or biotype of plant, animal or pathogenic agent injurious to plants

or plant products. (ISPM 5)

Quality management system (QMS) - A formalized system that documents processes,

procedures and responsibilities for achieving quality policies and objectives. Components of

a QMS include a quality policy, which is the commitment and goal towards which the entity

is working; standard operating procedures that are executed to produce the quality seed; a

system for training, auditing and issuing corrective actions; continuous improvement; and

risk evaluation and mitigation. (ReFreSH Concept Paper)

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 being officially

controlled. (ISPM 5).

Reaccreditation audit- Audit conducted by the authorizing NPPO or its designee prior to the

end of the ReFreSH accreditation period/audit cycle. The purpose is to verify that an entity
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continues to conform to processes and procedures described in their ReFreSH Manual to

meet the requirements of the ReFreSH Standard. The reaccreditation audit is a systems

audit. Entities that are in conformance shall maintain their accreditation and listing in the

authorizing NPPO’s registry of accredited ReFreSH entities.

ReFreSH Manual- A document produced by a participating entity that specifies procedures

and processes undertaken by the entity and applied to their seed supply system as part of a

systems approach to meet the requirements of the ReFreSH Standard. It describes key staff

resources; staff training; a physical description of the entity’s facilities; their Seed Health

Management Plan (see below); records and document management; and reporting,

monitoring and corrective measures including internal audit procedures.

Regulated non-quarantine pest- A non-quarantine pest whose presence in plants for

planting (including seed for planting) affects the intended use of those plants with an

economically unacceptable impact and which is therefore regulated within the territory of

the contracting party. (ISPM 5)

Regulated pest- A quarantine pest or a regulated non-quarantine pest. (ISPM 5)

Risk Evaluation/Hazard Analysis- A process of identifying risks or hazards, critical control

points and best management practices to mitigate introduction and movement of regulated

pests within an entity’s seed supply system. The process identifies and prioritizes the

hazards that must be monitored and controlled throughout all steps described in the seed

supply system but concentrates on the steps where pest risk management could be applied.

(SANC)

Seedborne pest- A pest carried by seeds externally or internally that may or may not be

transmitted to plants growing from these seeds and cause their infestation. (ISPM 38)

Seeds- Seeds for planting or intended for planting and not for consumption or processing.

(ISPM 5)

Seed Health Management Plan (SHMP) - A document written by the entity to describe

plant pest risk management at the critical control points identified during the entity’s risk

evaluation/hazard analysis of the seed supply system. This SHMP includes, but is not limited

to, procedures for scouting, record keeping, and reporting regulated pest detections.

Seed transmitted pest- A seedborne pest that is transmitted via seeds directly to plants

growing from these seeds and causes their infestation. (ISPM 38)

Surveillance Audit- Verification by the authorizing NPPO of the ongoing conformance of the

entity to activities described in its ReFreSH Manual to meet by conducting audits on specific

portions of its seed supply system. (GCP)
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Systems approach- A pest risk management option that integrates different measures, at

least two of which act independently, with cumulative effect. (ISPM 14)

Systems audit- A systematic and independent examination of the complete organizational

structure, procedures, processes and resources of an entity to determine whether they and

related results comply with the ReFreSH Standard and are implemented effectively. (GCP,

RSPM 28)

1. GENERAL REQUIREMENTS

ReFreSH is designed to enable entities to produce seed free of regulated pests and meet the

phytosanitary requirements of the importing and exporting country or countries.

1.1. U.S. Legislative Authority

• Plant Protection Act of 2000, SEC. 401. 7 U.S.C. 7701

• Title 7 Code of Federal Regulations, Part 319 Subpart H: Plants for Planting

• USDA Plants for Planting Manual

• Title 7 Code of Federal Regulations, Part 353 Export Certification

• Title 7 Code of Federal Regulations, Part 360 Noxious Weed Regulations

• Title 7 Code of Federal Regulations, Part 361 Importation of Seed and Screenings

under the Federal Seed Act

1.2. Eligible Commodities. All seeds currently admissible with phytosanitary certification

and not specifically restricted by participating NPPOs along the seed supply system are

eligible under the ReFreSH Standard. 

1.3. Eligible Entity. Any entity that agrees to produce or distribute seed using best

management practices as documented in a quality management system that meets the

ReFreSH Standard is eligible to participate in ReFreSH.

1.4. Fees. Applicable fees shall be determined by the NPPO authorizing an entity’s

participation in ReFreSH. Fees may include charges for audits, inspections, or

document review, etc. 
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2. APPLICATION AND ENROLLMENT IN THE REFRESH PROGRAM

2.1. Application. The entity must apply for ReFreSH enrollment to the authorizing NPPO(s)

or official designees (henceforth, authorizing NPPO) in the country where the seed

supply system activity or activities to be authorized under ReFreSH occur(s), (e.g., seed

is grown, conditioning, packaging, etc.). In the case of brokers, the entity must apply to

the authorizing NPPO of the country from which the seed is exported or re-exported. 

The entity will submit a ReFreSH Manual (see Section 3.1) or equivalent documentation

to the authorizing NPPO. The authorizing NPPO will review the documentation to

ensure that it contains all the required elements and that it is sufficient to meet the

requirements of the ReFreSH Standard.

2.2. Accreditation Audit. The authorizing NPPO(s) will complete an audit to verify the entity

has successfully implemented the system as described in their ReFreSH Manual.

2.3. Enrollment. The entity and the authorizing NPPO will sign a ReFreSH agreement

indicating the authorizing NPPO’s acceptance of the entity into the ReFreSH program,

and the entity’s understanding and agreement to comply with the ReFreSH Standard.

3. NPPO RESPONSIBILITIES

3.1. ReFreSH Authorizing NPPO

3.1.1. Program Administration. The authorizing NPPO(s) will establish and maintain a

ReFreSH program, using the ReFreSH Standard. The NPPO may authorize an

official designee(s) to perform aspects of the ReFreSH program. Such official

designees are required to establish and maintain the ReFreSH program in

accordance with applicable sections of the ReFreSH Standard and any additional

requirements set forth by the authorizing NPPO.

3.1.2. Program Review. The authorizing NPPO will periodically review the ReFreSH

program performance and identify issues and potential improvement. The review

should cover non-compliance information, including suspension, cancellation and

notices of non-compliance, non-conformance, evaluation of the program

components and any relevant new information.

3.1.3. Program Enrollment. The authorizing NPPO will review an entity’s application,

including initiating meetings as needed (see Section 2). The authorizing NPPO

shall deny participation to any entity that cannot meet the requirements of the

ReFreSH Standard. Participating NPPOs have the sovereign right and

responsibility to determine if the entity’s SHMP provides an adequate level of

phytosanitary protection.
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3.1.4. Registration. The authorizing NPPO will maintain a registry of accredited

ReFreSH entities. When a ReFreSH accreditation is suspended or an entity

voluntarily withdraws from the ReFreSH program the entity will be removed from

the registry of accredited ReFreSH entities.

3.1.5. Records. The authorizing NPPO will maintain the following information for each

accredited entity:

• The original application package that was submitted to the authorizing NPPO;

• Copies of all signed ReFreSH agreements;

• Copy of the Seed Health Management Plan; 

• Copies of all audit reports;

• Copies of all corrective action requests;

• Any written statements of corrective actions taken by the entity;

• Copies of any notifications of suspension and/or reinstatement; and

• Copies of any correspondence between the entity and the authorizing NPPO.

The authorizing NPPO will maintain such records in accordance with government

record retention policy

3.1.6. Audits. The authorizing NPPO will conduct regular audits of all enrolled entities

and will prepare reports that summarize their findings. Should audits identify any

critical or minor non-conformance, the authorizing NPPO will ensure the nonconformance has been addressed by the entity within the specified time frame (see

Section 5). The authorizing NPPO should review the SHMP as part of each audit.

3.1.6.1. Audit Frequency. At a minimum, audits by the authorizing NPPO will

be conducted on a three (3) year cycle. The number of audits and

whether they are announced or unannounced may change based on

the entity’s compliance and any imposed or proposed changes to the

entity’s ReFreSH Manual.

3.1.6.2. Accreditation audit. (Year 0) The Accreditation audit is a specific type

of systems audit that is conducted after a facility’s ReFreSH

application package has been reviewed and accepted by the

authorizing NPPO and prior to enrollment into the ReFreSH program.

The objective of the accreditation audit is to verify that the entity has

the necessary procedures, processes, systems, tools and a SHMP that

result in consistently meeting the requirements of the ReFreSH

Standard. This audit will allow the entity to make any corrections, if

needed, for initial certification. Entities that are in compliance will be
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authorized and added to the authorizing NPPO’s registry of accredited

ReFreSH entities. The intervals for subsequent surveillance and

reaccreditation audits are set by the authorization date.

3.1.6.3. Surveillance audit(s). (Years 1-2) The authorizing NPPO should

conduct one or more surveillance audits of the entity prior to

reviewing their certification in the third year. Surveillance audits

verify the ongoing compliance of the accredited entity with the

requirements of the ReFreSH Standard by conducting audits on

specific portions of the seed supply system. The audits should

encompass the complete organizational structure over time.

3.1.6.4. Reaccreditation audit. (Year 3) The authorizing NPPO or its designee

shall review all aspects of the entity’s necessary procedures,

processes, systems, tools and a SHMP that result in consistently

meeting the requirements of the ReFreSH Standard. Entities that are

complying shall maintain their accreditation and listing in the

authorizing NPPO’s registry of accredited ReFreSH entities. The cycle

of audits described above is repeated.

3.1.7. Suspension/reinstatement of entity. The authorizing NPPO has the authority to

suspend an entity from participation in the ReFreSH program based on noncompliance and may reinstate it as appropriate (see Section 4.7).

3.1.8. Authorization. The authorizing NPPO(s) will provide approved entities a copy of

the signed ReFreSH agreement. The entity will be issued a unique identifier (i.e.,

an accredited entity number) indicating its accreditation.

3.2. Importing country NPPO

3.2.1. Import requirements. The importing country’s NPPO must establish their import

requirements and inform the exporting country or countries of the

requirements. 

3.2.2. Review. The importing country’s NPPO has the right to review the authorizing

NPPO’s process for accrediting ReFreSH entities to ensure compliance with their

import requirements. The importing NPPO may conduct audits to address

specific noncompliances; during this review, they may propose additional or

equivalent measures.

3.2.3. Monitoring. The importing country’s NPPO may conduct monitoring of imported

seeds.
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3.2.4. Notification of non-compliance. The importing country’s NPPO shall notify the

authorizing NPPO of any non-compliance with the importing NPPO’s regulatory

requirements. 

4. NON-CONFORMANCE AND CORRECTIVE MEASURES

4.1. Types of Non-conformance. A non-conformance is any failure to adhere to the

procedures described in the entity’s ReFreSH Manual to meet the requirements of

the ReFreSH Standard. The ReFreSH program distinguishes between two types of

non-conformance taking into account the severity of the non-conformance. 

4.1.1. Critical non-conformances. Critical non-conformances are incidents that

compromise the efficacy of an entity’s ReFreSH processes and procedures or

increase the risk of infestation of the seed supply system. A critical nonconformance may result in immediate suspension from the program. See

Appendix for examples.

4.1.2. Non-critical non-conformances. Non-critical non-conformances are incidents

that do not immediately compromise the ReFreSH processes and procedures or

increase the risk of infestation of the seed supply system. Repeated, multiple, or

failure to correct non-critical non-conformances may result in suspension of the

entity’s ReFreSH accreditation. See Appendix for examples.

4.2. Non-conformance detection and determination of status. A non-conformance may

be detected during internal audits by the entity, or during external audits conducted

by the authorizing NPPO.

4.3. Detection by authorizing NPPO. If detected by the authorizing NPPO, the entity will

be informed in writing of the non-conformance and the need for corrective actions

(See Section 4.6). The entity must make corrections promptly, and within a mutually

agreed upon timeframe.

4.4. Detection by the entity. If detected by the entity, the non-conformance must be

documented along with any corrective actions taken. If a critical non-conformance is

detected by the entity, the NPPO must be notified within 48-hours of the nonconformance and corrective actions taken. Failure to notify the NPPO of a critical

non-conformance will result in immediate suspension of the entity’s ReFreSH

accreditation. A critical non-conformance may require a root cause analysis and

subsequent changes to the ReFreSH Manual.

4.5. Detection by the importing country NPPO. The detection of a ReFreSH product or

process that fails to comply with the stated phytosanitary requirements of the NPPO

of the importing country is a non-compliance. The importing country NPPO shall

inform the authorizing NPPO of the non-compliance. The authorizing NPPO will
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inform the entity if the non-compliance has caused a non-conformance or requires a

change to their ReFreSH Manual.

4.6. Corrective action requests. Corrective Action Requests (CARs) are used by the NPPO

to formally communicate and record non-conformances and their resolution. A

corrective action request will be completed for each non-conformance identified,

including those resulting from a non-compliance. For each CAR, the entity will

propose a detailed description of the action(s) the entity will implement to prevent

recurrence of the non-conformance and a timeframe for completing the action(s).

CARs for critical non-conformance(s) require review by the authorizing NPPO. Failure

to follow the prescribed actions may result in suspension of the entity’s ReFreSH

accreditation.

4.6.1. Corrective actions for critical non-conformances. The entity must submit CARs

for critical non-conformances must be submitted to the authorizing NPPO for

review and approval within 48 hours of detection. The authorizing NPPO will

acknowledge receipt of the CAR and begin its review within seven (7) business

days.

4.6.2. Corrective actions for non-critical non-conformances. The entity will submit

CARs for non-critical non-conformance(s) within a mutually agreed upon time

frame to the authorizing NPPO for review and approval.

4.6.3. Implementation. The entity may implement corrective actions immediately

pending review and approval by the authorizing NPPO.

4.7. Suspension of accreditation. Entities, or relevant part(s) thereof, unable to

maintain the requirements of the ReFreSH Standard or misrepresenting / misusing

information related to ReFreSH accreditation, will be immediately notified by the

authorizing NPPO of the suspension of the entity’s ReFreSH accreditation. Entity

participation may also be suspended if program fees are not paid. The suspended

entity will be removed from the authorizing NPPO’s registry of accredited ReFreSH

entities until or unless its accreditation is reinstated by the authorizing NPPO.

Suspended entities shall not ship seed using their official ReFreSH identifier.

4.8. Reinstatement of suspended entities. An entity, or relevant part(s) thereof,

suspended from the ReFreSH Program may be reinstated after the authorizing NPPO

has received a request for reinstatement and documentation of completed

corrective actions related to the suspension. The authorizing NPPO will verify
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completion of corrective actions and issue a determination regarding the request for

reinstatement.

4.9. Cancellation of the ReFreSH agreement. An entity’s ReFreSH agreement will be

cancelled by the NPPO when:

• The facility is unable to maintain consistent compliance or achieve

compliance within a reasonable period of time; or,

• The entity voluntarily withdraws from their ReFreSH agreement.

The NPPO will notify the accredited entity when their ReFreSH agreement has been

cancelled. Entities whose ReFreSH agreement has been cancelled may reapply for

designation as an accredited entity in the ReFreSH program. If so, the entire

application and approval process must be reinitiated, including submitting an

application form and a revised ReFreSH Manual. The NPPO may refuse to

reauthorize entities at their discretion.

5. REFRESH PARTICIPATING ENTITY RESPONSIBILITIES

 

5.1.ReFreSH Manual. The entity must complete a ReFreSH Manual to record details about

its facilities, key personnel and specific activities for healthy seed production. System

components listed below are required for authorization and must be described in the

entity’s ReFreSH Manual or equivalent documentation, [e.g., a manual documenting

equivalent, applicable accreditation such as International Organization for

Standardization (ISO) or Good Seed and Plant Practices (GSPP)]. The ReFreSH Manual

must describe the processes and procedures used to manage the risk of pest

introduction or spread within and via the entity’s seed supply system.

The entity is required to notify the authorizing NPPO of any changes to the ReFreSH

Manual, facility ownership or the ReFreSH manager at their facility. The ReFreSH

Manual should be amended to reflect these changes. This may trigger an evaluation

of the amended document by the authorizing NPPO.

Entities must apply to request changes to the scope of an entity’s ReFreSH

accreditation (e.g., additional seed commodities). Applications must be submitted to

the authorizing NPPO for approval. These requests may trigger an audit.
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5.1.1. Staff and Facility

5.1.1.2. Management and Organization. Participating entities must provide a

description of the organizational structure and responsibilities of the relevant

personnel responsible for the implementation of ReFreSH processes and

procedures. The management for each entity must define a policy that

ensures compliance with the ReFreSH Standard and allocates the necessary

resources to meet the ReFreSH Standard. The entity must assign a point of

contact for ReFreSH and maintain a list of key staff and their ReFreSH-related

responsibilities.

5.1.1.3. Qualifications. The ReFreSH point of contact may designate qualified

personnel or contractors to assist with specific components of the entity’s

ReFreSH processes and procedures. The individuals designated to carry out

tasks related to ReFreSH must have adequate knowledge, skills and training,

and must be vested with the authority to ensure the requirements of the

ReFreSH Standard are met.

5.1.1.4. Staff Training. The entity must have a training plan for all employees

involved in ReFreSH processes and procedures. The training must impart a

general understanding of ReFreSH and the entity’s SHMP, as well as specific

knowledge related to each employee’s responsibilities. The training plan

must be reviewed by entity management annually. Training on elements of

ReFreSH shall be provided to employees at least annually.

5.1.1.5. Entity Description. A physical description of all entity facilities covered by

their application must be incorporated in their ReFreSH Manual. This

includes, but is not limited to, relevant production, operation and seed

testing locations. As appropriate, include a description of the entity’s

requirements for contract vendors.

5.1.2. Seed Health Management Plan. The entity must complete a SHMP to record

details about its specific processes and procedures for healthy seed production.

It must describe how the plan is maintained and reviewed. The entity is required

to notify the authorizing NPPO when they propose any changes to the SHMP;

this must occur prior to implementing the changes. Seedborne pests, as defined

in ISPM 38, and occurring in the country or countries of seed origin listed in the

entity’s application, must be included in the SHMP. The entity must conduct a

risk evaluation / hazard analysis to assess the following critical control points in

the seed supply system where pests may be introduced or spread: 
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• Pre-planting

• Site Selection and Preparation 

• Seed and Plant Inputs

• Pre-harvest

• Production 

• Seed Harvest 

• Post-harvest

• Conditioning and Treatment 

• Handling and Storage

• Seed Testing 

• Distribution and Transport

The pest risks (hazards) identified by the assessment and the measures or

practices applied at each critical control point to manage those risks must be

specifically described in the SHMP. Examples of potential management practices

that may be implemented at each critical control point are described in ISPMs 14

and 38. The SHMP must be implemented throughout the ReFreSH-accredited

entity in a manner that will ensure consistent compliance with the requirements

of the ReFreSH Standard.

5.1.3. Identification and tracking. Accredited entities must have procedures and

processes in place that maintain product identity (i.e., traceability) from the

point it enters the entity’s seed supply system until its final disposition/delivery

to the customer.

5.1.4. Internal Audits and System Improvement. A process for regular internal audits

must be established, described and implemented to verify conformance to the

ReFreSH Manual, verify that systems are functioning as designed and identify

opportunities for system improvement. The internal audits should be sufficient

to cover all aspects of the ReFreSH Manual. Internal audits shall not be carried

out by personnel who are directly responsible for the audited activity.

5.1.5. Records and Documents. All records must be maintained and made available to

the authorizing NPPO upon request.

5.1.5.1. Control of the ReFreSH Manual and Documents. The entity must describe

its process to maintain and control the ReFreSH Manual, documents and

records required by the ReFreSH Standard. This process must include

procedures for superseding and archiving obsolete documents. The entity

must establish a procedure to review the ReFreSH Manual on a regular

basis. At a minimum, all sections of the ReFreSH Manual must be reviewed
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every three (3) years. Individual sections in the Manual may be reviewed

more frequently as needed.

5.1.5.2. Record Requirements for ReFreSH. The entity must establish a retention

policy for all records pertaining to ReFreSH. The minimum acceptable

retention period is four (4) years. The retention period begins once the

seed is no longer under the control of the accredited entity (i.e., has

reached its final disposition). Where an entity performs different seed

supply system processes at multiple locations, each location must maintain

records for the accredited processes within their purview. Records subject

to this requirement include but are not limited to the following:

• Traceability. A process to maintain traceability of seed for the entire

period it is under an entity’s control, including processes and

procedures by contractors, must be established and documented.

Records must verify the origin and phytosanitary status of the seed.

• Audits. Records of both internal and external audits and any corrective

actions, recommendations for improvement and resulting changes to

the ReFreSH Manual taken as a result of those audits.

• Seed Health Management Plan. Records (e.g., monitoring reports, pest

detections, corrective actions, treatment records, diagnostic test

results, etc.) verifying the steps of the SHMP were followed.

• Training. Records documenting required ReFreSH-related training.

Records should include verification that training has occurred and

evidence of regular review of training materials. 

5.1.6. Regulated pest reporting and response. The ReFreSH Manual must include an

agreed upon procedure for reporting regulated pest detections and corrective

actions taken to the authorizing NPPO. This includes detections at the

accredited entity or its contractor(s). The procedure must a root cause analysis

to identify how the pest was introduced into the seed supply system,

adjustments to the SHMP may be adjusted in response, and how the efficacy of

those adjustments may be verified.
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APPENDIX: EXAMPLES OF NON-CONFORMANCE

This appendix is for reference purposes only and is not a prescriptive part of this standard.

Some examples of critical non-conformances may include the following:

• Detection of quarantine pests or regulated non-quarantine pests (above set

tolerance levels; regulated non-quarantine pests only) of concern to the importing

country;

• Failure to undertake required laboratory tests or analyses or correctly follow

procedures to identify pests;

• Failure to carry out control measures at the place of production for regulated pests;

• Failure to notify the authorizing NPPO of the presence of regulated pests at the

entity;

• Failure to undertake ordered corrective actions within the specified time period;

• Failure to perform internal audits as required;

• Failure to maintain an effective pest management program;

• Significant modification of the ReFreSH Manual or SHMP without prior approval

from the authorizing NPPO;

• Failure to maintain sanitation management practices at the place of production; or,

• Operating without adequately trained personnel, designated responsible person or

plant protection specialist.

• Multiple non-critical non-conformances in a single audit.

• Repeated occurrences of the same non-critical non-conformances during different

audits.

Some examples of non-critical non-conformances may include the following:

• Failure to keep consistent pest management records as required in the ReFreSH

Manual and the SHMP;
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• Failure to maintain an up-to-date list and training records of all personnel involved in

implementing ReFreSH; or,

• Failure to consistently sign and date reports or records.

• Staff members are not aware of the applicable ReFreSH requirements related to

their duties.