ReFreSH

Regulatory Framework for Seed Health

Participant Manual / July 1, 2021

Draft
ReFreSH Participant Manual 07/01/2021 i

Contents

Introduction .......................................................................................................................... 1

Template ............................................................................................................................... 2

A. Staff and Facilities ................................................................................................................................2

B. Seed Health Management Plan ............................................................................................................4

C. Internal Audits and System Improvements...........................................................................................8

D. Records and Documents.......................................................................................................................9

E. Change Management .........................................................................................................................11

F. Reporting and compliance..................................................................................................................12

APPENDIX I: Risk Evaluation/Hazard Analysis.....................................................................A1

Table 2. Risk Evaluation/Hazard Analysis Example .................................................................................. A3

Table 3. Examples of pest types and possible risk management measures for them.............................. A19
ReFreSH Participant Manual 07/01/2021 1

Introduction

The Regulatory Framework for Seed Health (ReFreSH) is a pest risk-based systems approach alternative to

consignment-by-consignment inspection. It will serve as the basis for phytosanitary certification for the

international movement of seeds, including seed importation into the United States. Any entity that agrees to

produce or distribute seeds best management practices as documented in a quality management system that

meets the ReFreSH Standard is eligible to participate in ReFreSH. Public or private entities that seek to be

accredited to participate in ReFreSH are required to have a ReFreSH Manual, which describes the processes

and procedures required to meet the ReFreSH Standard (USDA. 2020. Regulatory Framework for Seed Heath

(ReFreSH) Standard).

This document is intended to assist an entity in developing a ReFreSH Manual that meets the requirements of

the ReFreSH Standard. An alternative, phytosanitary plan or equivalent documents may be utilized in lieu of to

ReFreSH manual. The equivalent documentation could include a manual documenting equivalent, applicable

accreditation, for example International Organization for Standardization (ISO) or Good Seed and Plant

Practices (GSPP) accreditation documents. The ReFreSH Manual, or equivalent authorization standards or

phytosanitary plan, must describe the processes and procedures used to exclude pests from the entity’s seed

supply system.

The components listed below are required for authorization and must be described in the entity’s ReFreSH

Manual:

A. Staff and facilities

• Management and organization

• Staff training and qualifications

• Entity description

B. Seed health management plan

• Pre-planting

• Pre-harvest

• Post-harvest

C. Identification and Tracking

D. Internal audits and system improvements

E. Records and related documents

• Control of the Manual and documents

• Record requirements

• Traceability

• Audits

• Pest management plan records

• Training records

F. Change management

G. Reporting and compliance
ReFreSH Participant Manual 07/01/2021 2

Requirements for each of these sections are listed below. The entity’s ReFreSH manual must be submitted

along with their ReFreSH application to the authorizing National Plant Protection Organization (NPPO) or its

designee for review and approval prior to an accreditation (or reaccreditation) audit (refer to the ReFreSH

Standard for definitions) to determine whether an entity is authorized (or reauthorized) to participate in

ReFreSH. All documents and procedures referenced in the Manual are subject to official audits.

Template

A. Staff and Facilities

Participating entities must provide a description of the organizational structure including responsibilities and

qualifications of the relevant personnel responsible for meeting the requirements of the ReFreSH Standard.

The entity must assign a point of contact and maintain a list of key staff and their ReFreSH-related

responsibilities.

The entity must have a training plan for all employees involved in ReFreSH. The training must impart a general

understanding of the ReFreSH Standard and the entity’s specific seed health management plan, 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 the ReFreSH Standard and the Seed Health Management Plan

must be provided to employees at least annually or upon hiring or reassignment to a ReFreSH-related position.

The entity must include in their ReFreSH Manual, a physical description of all entity facilities covered by their

ReFreSH application. This includes, but is not limited to, relevant production, operation and seed testing

locations. As appropriate, the entity must include a description of their requirements for contract vendors.

Section ReFreSH Standard Component

A.1. Management and Organization

A.1.1. Policy and Entity Commitment

The ReFreSH Manual must contain a statement by the entity’s leadership of their

commitment to participate in and maintain the integrity of systems to meet the ReFreSH

Standard.

A.1.2. Resource Commitment

The ReFreSH Manual must contain a statement of the entity’s commitment to assign the

necessary resources to meet the requirements of the ReFreSH Standard.

A.1.3. Organization

The ReFreSH Manual must contain an organizational chart or description showing staff

positions assigned to manage the components of the entity’s ReFreSH Program, including its

Seed Health Management Plan (SHMP); key positions and their responsibilities as they

relate to all components of the entity’s ReFreSH Program should be described; and the

name and contact information for the entity’s designated ReFreSH point of contact should

be provided.

A.2. Staff training
ReFreSH Participant Manual 07/01/2021 3

Section ReFreSH Standard Component

The ReFreSH Manual must provide descriptions of the training required for staff involved in

planning, implementing and maintaining the entity’s ReFreSH Program, including the

following:

A.2.1. General

A general description of how the entity orients/trains employees on the ReFreSH Standard

and the entity’s policy and commitment toward the program.

A.2.2. Key personnel training

A description of the specific training required for personnel (including contract vendors, if

used) responsible for implementing and managing all parts of the ReFreSH Program

including the SHMP. Training for these positions should provide a thorough understanding

of the ReFreSH program; systems approach concepts; risk evaluation/hazard analysis and

identification of critical control points; pest management; audits; recordkeeping; document

control; and other topics as are relevant.

A.2.3. Basic training

A general description of the training and responsibilities of other positions associated with

the ReFreSH program. These staff may be responsible for a single element of the entity’s

ReFreSH Program or SHMP, such as traceability of seed lots or seed health testing. These

employees are required to have a basic understanding of the ReFreSH Program overall,

including its requirements and purpose.

A.2.4. Frequency of training

Training on elements of ReFreSH shall be provided to employees at least annually. A

description of how often staff are trained on the different elements of the entity’s ReFreSH

program.

A.3. Qualifications

The entity must document that staff associated with their ReFreSH program include, or have

access to, individuals with the following qualifications: 

• An advanced degree or equivalent work experience in identification, diagnosis and

management of plant pests;

• Technical knowledge of the identified seed health tests, plant health inspection

protocols and the visual and sampling procedures relevant to the accreditation;

• Experience in the development and implementation of quality management systems

A.4. Entity description

A.4.1. Entity and commodity

The ReFreSH Manual must include:

• The name, physical location and description of the entity facility(ies) seeking approval

including, as appropriate, production, operations, seed testing and/or distribution

facilities.

• The seed species that the entity will be producing or distributing under the ReFreSH

program.

A.4.2. Contractor facilities

The ReFreSH Manual must include, as appropriate, criteria used to ensure its vendors meet

the requirements of the ReFreSH Standard and the entity’s ReFreSH Program. This may

include portions of production, operations, or seed health evaluation that are contracted

out by the entity.
ReFreSH Participant Manual 07/01/2021 4

B. Seed Health Management Plan

The ReFreSH Manual must include a Seed Health Management Plan (SHMP). The SHMP includes the 

procedures entities use to reduce pest risk during all stages of the seed supply system. A risk evaluation (i.e., 

hazard analysis) must be conducted that analyzes the following critical control points in the seed supply 

system where pests may be introduced: 

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

Section ReFreSH Standard Component

B.1. Risk Evaluation/Hazard Analysis

Based on their risk evaluation/hazard analysis, the entity should describe the target pests

identified, methods of monitoring and potential management practices. A hazard analysis 

template is provided in Appendix I. Entities may also incorporate the template in their 

SHMP. The pest risks (hazards) identified by the analysis and the measures or practices 

applied at each critical control point to manage those risks must be described in the 

SHMP. 

Factors to consider in developing risk management options are listed in Sections B.2.-B.4. 

Examples of potential risk management options that may be implemented at each critical 

control point are described in ISPMs 14 and 38 and are listed in Tables 2 and 3 shown 

below.

B.2. Pre-planting

B.2.1. Site Selection and Preparation
ReFreSH Participant Manual 07/01/2021 5

Section ReFreSH Standard Component

Describe pre-plant field or growing facilities assessment and procedures that prevent or

mitigate pest introduction from the environment into the production site(s).

Factors that should be considered include:

• Soil quality and water sources

• Site cropping and disease history

• Endemic pests

• Isolation distance from other crops produced on-site or nearby

• Presence of weeds in production field

• Weed control in borders and adjacent fields

• Presence of volunteer plants and host debris from previous production cycles / earlier

growing seasons

• Presence of potential vectors

• Worker hygiene and sanitation

• Tool/equipment (including tractors and other field equipment) sanitation

• Accessibility of site, field, etc. by authorized and non-authorized persons

• For protected culture crops (including transplant houses): structure integrity and

sanitization prior to use or between production cycles

Additional factors that should be considered for transplant houses include:

• Sanitization or cleaning of seed beds

• Growing media used in transplant seed beds/pots/trays (new or sterilized only)

• Transplant containers (new or sterilized only)

• Storage of growing media and containers to avoid pest contamination

• Tool/equipment sanitation

B.2.2. Seed and Plant Inputs

Describe procedures used to prevent the introduction of pests from seeds, transplants,

other plant material, growing media and containers used in seed production. Describe

mitigation procedures used to prevent the spread of pests from materials sourced from

and to vendors.

Factors that should be considered include:

• Identification and tracking procedures

• Seed health testing / certification of parental seed lots

• Seed treatment applications

• Inspection or testing of seedlings/transplants prior to transplanting

• Diagnosis of diseased or symptomatic plants

• Disposal of contaminated seeds, plants, growing media and containers by APHIS–

approved methods

B.3. Preharvest

B.3.1. Production
ReFreSH Participant Manual 07/01/2021 6

Section ReFreSH Standard Component

Describe procedures used to prevent, monitor and mitigate pests during seed

production.

Factors that should be considered include:

• Accessibility of site, field, etc. by authorized and non-authorized persons

• Worker hygiene and sanitation

• Tool/equipment (including planter or tractor) sanitation

• Regular crop inspections of all plants including males (pollinator) plants

• Diagnosis of symptomatic plants by approved methods

• Disposal of diseased or symptomatic plants, growing media and containers (if

applicable) by APHIS–approved methods

• Monitoring for vectors

• Management of pests with appropriate crop protection materials (chemical or

biological) and cultural control practices (e.g., mulching, screens over access points in

greenhouses)

• If applicable, irrigation details (e.g., source, frequency)

• Weed control within and surrounding the production location (field, structure, etc.)

• Identification and tracking procedures

B.3.2. Seed Harvest

Describe procedures used to minimize seed contamination during harvesting and drying

at the production site(s).

Factors that should be considered include:

• Harvest criteria (maturity, timing) for the crop

• Visual inspection of plants and fruit prior to harvest

• Weather conditions (e.g., rain, dew) permitted at harvest

• If applicable, pre-harvest fruit washing or sanitizing procedures

• Harvest/seed extraction location (e.g., within a facility, in the field)

• Use of new or sanitized seed containers/bags

• Worker hygiene and sanitation

• Harvest equipment and tool sanitation and/or cleaning

• If applicable, seed drying location

• Drying equipment sanitation

• Identification and tracking procedures

B.4. Post-harvest

B.4.1. Conditioning and Treatment
ReFreSH Participant Manual 07/01/2021 7

Section ReFreSH Standard Component

Describe the procedures used to reduce the presence of seed-associated pests during

seed cleaning, conditioning, sizing and packaging.

Factors that should be considered include:

• Seed sampling and testing

• Seed washing and/or disinfection

• Seed treatments

• Seed operations equipment and tool sanitization and/or cleaning

• Proper disposal of all remnant and unusable seeds and debris

• Disposal of all seeds found to be contaminated with regulated pests in accordance to

regulatory guidelines

• Worker sanitation and hygiene

• Identification and tracking procedures

B.4.2. Handling and Storage

Describe procedures to prevent the introduction and spread of seed-associated pests

during postharvest handling and storage. The measures should address all stages in the

process, i.e., filling, handling, storage, and distribution of containers between the

entity’s facilities or from a vendor to the entity’s facilities.

Factors that should be considered include:

• Segregation and physical separation of untested and tested seed inventories

• Seeds stored in closed containers under monitored warehouse conditions of controlled

temperature and humidity

• Warehouse sanitation including regular cleaning, immediate clean-up of seed spills,

removal of waste or unused seeds

• Equipment and tool sanitization and/or cleaning

• Worker hygiene and sanitation

• Identification and tracking procedures

B.4.3. Seed Testing
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Section ReFreSH Standard Component

Describe the seed health testing procedures and methods used to ensure that the

entity’s seed supply system is free of regulated pests. ReFreSH generally follows the PPQ

policy that all sampling, inspection, and testing for seed health certification be

conducted by government officials or accredited non-government entities. ReFreSH

requires that all seed health testing uses methods that have been standardized or

validated through the National Seed Health System (NSHS), Naktuinbouw Authorized

Laboratory (NAL) program or the International Seed Testing Association (ISTA), if

available, or by other methods accepted by the authorizing NPPO. Likewise, ReFreSH

requires the use of seed sampling methods described by the International Seed Testing

Association (ISTA) or the Association of American Seed Control Officials (AASCO).

Factors that should be considered include:

• Identification and tracking procedures

• Accreditation or authorization status of seed health testing laboratories

• Authorization status of methods used for seed health testing

• Use of seed sampling methods described by the International Seed Testing Association

(ISTA) or the Association of Seed Control Officials (AASCO)

• Use of official seed samplers, if applicable

• Seed sampling equipment cleaning, sanitization and calibration 

• Use of new sample collection bags

• Training of laboratory staff on appropriate testing methodologies and good laboratory 

practices

• Laboratory and greenhouse sanitation 

• Laboratory equipment and tool cleaning, sanitization, calibration and maintenance

• Standard data interpretation for authorized methods

• Remnant seeds and debris properly disposed of in accordance with local regulations 

and good laboratory practices

B.5. Distribution and Transport

Describe procedures used to mitigate seed-associated pests in seeds that are distributed

outside of the accredited entity facility. Procedures used to meet international

phytosanitary regulatory requirements must be included.

Factors that should be considered include:

• Identification and tracking procedures

• Entity’s compliance with seed quality release criteria for customer, market and

country import requirements

• Safeguarding measures to maintain shipment integrity

C. Internal Audits and System Improvements

The ReFreSH Manual must include procedures for system improvements. In other words, the ReFreSH 

Manual must describe a quality management system employing internal audits conducted on a regular 

basis. The audits must confirm that the requirements specified in the ReFreSH Standard are met and 
ReFreSH Participant Manual 07/01/2021 9

identify elements that contribute to any non-compliance. These audits will also facilitate the continuous 

improvement of the ReFreSH program at the authorized entity. 

Section ReFreSH Standard Component

C.1. Responsible Party

The ReFreSH Manual must include the title and position of the person responsible for the 

audits and system improvements program.

C.2. Auditing

Procedures establishing a timeline, scope, reporting, and retention of the audit results and 

other applicable documentation must be demonstrated.

The manual should:

• Establish a schedule of internal audits over the course of each year

• The internal audits must be sufficient to ensure all processes and procedures conform 

with those described in the ReFreSH Manual 

• Ensure the internal audits encompass all aspects of the Manual including the SHMP

during the period between certification and the recertification audit

C.3. Corrective Actions and System Improvements

Procedures for implementing corrective actions when non-conformances are detected

including:

• for conducting root cause analysis to prevent recurrence, and 

• for proactively developing system improvements must be described. 

These may occur both within and outside of the audit process.

C.4. NPPO Notification

Procedures used to notify the NPPO of non-conformances that were detected while 

conducting internal audits and of corrective actions taken must be demonstrated.

• The authorizing NPPO and local officials are notified of any critical nonconformance, e.g., suspected regulated pest detection, within 48 hours followed by 

official confirmation of the pest identity and determination of the regulatory 

response.

• Procedure to notify the authorizing NPPO of any non-critical non-conformances at 

least sixty (60) days prior to a scheduled external audit.

D. Records and Documents

Records provide evidence that seeds produced by the entity comply with the requirements of the ReFreSH Standard. 

Records must be made available during audits or upon request of the NPPO. The entity must describe its process to 

maintain and control the Manual, documents and records required by the ReFreSH Standard. This process must include 

procedures for superseding and archiving obsolete documents.
ReFreSH Participant Manual 07/01/2021 10

Section ReFreSH Standard Component

D.1. Control of the Manual and documents

The entity must establish a procedure to review the Manual on a regular basis. 

The Manual should include:

• The position/title of person(s) with authority to approve changes to the Manual

• The process for making and documenting those changes

• Details of how the document is controlled to assure that it is secure and that only the

current version is available

• The timeline for Manual review ensuring that all sections of the Manual are reviewed

within a maximum three (3) year cycle (individual sections may be reviewed more

frequently, as needed)

D.2. Record requirements

The Manual must include procedures to maintain the following records and must include

position/title of person(s) responsible for maintaining records.

D.2.1. Record retention

• All records must be maintained for a minimum of four (4) years and be made available

to the NPPO upon request.

D.2.2. Traceability Records

The Manual will describe procedures and records to be retained that ensure traceability of

seed lots from the point it enters the seed supply production system until final disposition.

• Records include seed import and transplant crop records (trace forward/trace back)

• Records will be maintained and available for review by the NPPO

• Records can include certificates or invoices which substantiate the origin and

phytosanitary status of incoming propagative material

D.2.3. Systems Improvement Records

The Manual shall describe procedures to maintain records of internal and external audit

documents.

Systems improvement records maintained and made available for review by the NPPO

include:

• All internal/external audit reports

• Non-conformance records

• Corrective action and system improvement records

• Root cause analyses records.

D.2.4. Seed Health Management Plan (SHMP) Records
ReFreSH Participant Manual 07/01/2021 11

Section ReFreSH Standard Component

The Manual shall describe procedures that shall ensure all SHMP records are maintained

and available for review by the NPPO.

Examples of SHMP records maintained include:

• Soil and growing medium sterilization records

• Soil and water test results

• Transplant and production facility sanitation/disinfection records

• Production site inspection data

• Records of symptomatic plants observed, and plants removed

• Records of pest detections and corrective actions

• Records of regulated pests found and of notification(s) sent to the authorizing NPPO

• Records of pesticide applications

• Seed health test results

• Seed treatment records

• Storage facility environmental monitoring data

• Disposal records for remnant or contaminated seeds

D.2.5. Training Records

Describe procedures that ensure all training records, training materials and a list of

employees trained are maintained and available for review by the NPPO.

Records must be maintained for training activities specific to the entity’s ReFreSH

program. Examples include:

• Records of training dates/frequency, content and format

• Records of staff participants (trainers and trainees)

• Records of reviews and updates of training materials

E. Change Management

Changes resulting from regular reviews of the Manual, internal audits, changes in phytosanitary status, changes in 

technology, changes in business models or system improvement efforts may create a need to modify the Manual. The 

Manual must describe the mechanisms for managing any changes. This requirement applies to all aspects of the entity’s 

ReFreSH program.

Section ReFreSH Standard Component

E.1. Changes to the ReFreSH Manual that may affect phytosanitary risk within the seed supply 

system

• Changes must be communicated with and approved by the authorizing NPPO prior to 

adoption. Such communication shall be done by the point of contact for the entity’s 

ReFreSH program

E.2. Minor changes to the ReFreSH Manual

• Minor changes to the ReFreSH Manual that will not affect the phytosanitary risk within 

the seed supply system shall be communicated to the authorizing NPPO as part of the 

external audit noted in E.3. below.

E.3. Scheduled external audit / applying for re-accreditation
ReFreSH Participant Manual 07/01/2021 12

Section ReFreSH Standard Component

• The point of contact for the ReFreSH Manual shall provide the authorizing NPPO the 

most recent version of the entity’s ReFreSH Manual at least 60-days prior to a 

scheduled external audit and when applying for re-accreditation.

F. Reporting and compliance

The Manual must include a description of the standard procedure for maintaining contact with the NPPO and must 

include the title and contact information of the NPPO official (or authorized designee) responsible for overseeing 

authorization of the entity’s ReFreSH program and Manual. 

Section ReFreSH Standard Component

F.1. Point of contact

• All inquiries and reports of non-conformances with the ReFreSH Standard should be directed to 

the authorizing NPPO’s designated ReFreSH point of contact (see section C.4.)

F.2. Notification of critical non-conformances

• Any incident that may compromise the efficacy of the entity’s ReFreSH program or has increased 

the risk of infestation of the entity’s seed supply system by a regulated pest (i.e., a critical nonconformance) must be reported to the authorizing NPPO within 48-hours

F.3. Detection of a regulated pest

• Any entity detection of a regulated pest that indicates a critical non-conformance within its seed 

supply system must be reported to the authorizing NPPO within 48 hours and the proposed 

corrective action must be enacted within a mutually agreed-upon time frame.

• Notification of a non-compliance (i.e., detection of a regulated pest) by the NPPO of a 

destination country will result in a proposed corrective action within a mutually agreed upon 

time frame.

F.4. Non-critical non-conformances

• Incidents that do not immediately compromise the ReFreSH Program or increase the risk of 

infestation of the seed supply system by a quarantine pest (i.e., minor non-conformances) shall 

be reported to the authorizing NPPO at least 60-days prior to a scheduled external audit, or may 

be reported more frequently as determined by the entity’s quality management process.
ReFreSH Participant Manual 07/01/2021 A- 1

APPENDIX I: Risk Evaluation/Hazard Analysis 

The model/template shown below is included to assist entities with their risk evaluation/hazard analysis (see section B.1. 

Risk Evaluation/Hazard Analysis). The template is adapted from Systems Approach for Nursery Certification (SANC) Risk 

Assessment Tool (https://sanc.nationalplantboard.org/certification/risk-assessment/). The entity should describe the target 

pests included in the scope of their ReFreSH accreditation, critical control points, potential management practices and

monitoring methods. Entities may also incorporate the template in their SHMP. The risk assessment identifies phases and 

practices of seed production where risk of pest introduction or spread may occur. The pest risks (hazards) identified by the 

analysis and the measures or practices applied at each critical control point to manage those risks must be described in the 

SHMP. The seed supply system phases addressed correspond to the SHMP Sections B.2. through B.5.described above: 

B.2. Pre-planting: Site Selection and Preparation, Seed and Plant Inputs

B.3. Pre-harvest: Production, Seed Harvest

B.4. Post-harvest: Conditioning and Treatment, Handling and Storage, Seed Testing

B.5. Distribution and Transport

Appendix 1 consists of three tables. Table 1 provides general instructions for using the hazard analysis tool. Table 2 

describes generic hazards and risks and risk management measures for the identified hazard/risk at the critical control points 

noted above. These are intended as examples only. They may not all apply to every entity / commodity / pest / hazard 

combination. Conversely some combinations may require additional entries. The entity should add or delete entries as 

appropriate for their seed supply system proposed for ReFreSH authorization. There are also examples of training / 

knowledge requirements and records requirements that may be useful in developing the entity’s ReFreSH Manual. Finally, 

Table 3 provides a list of selected categories of pests and corresponding risk management measures for those pests.
ReFreSH Participant Manual 07/01/2021 A- 2

Table 1. Risk Evaluation/Hazard Analysis Instructions

Seed Health Management Plan Information ReFreSH Manual Information

Information from these entries is incorporated into the entity’s SHMP Information from these entries is incorporated into the appropriate 

sections of the entity’s ReFreSH Manual

Commodity / 

Pest(s)

Critical Control Point Risk / Hazard Risk Management 

Measures

Monitoring / Verification Responsible 

Person

Training / 

Knowledge

Records

List the seed taxa 

for which the entity 

seeks to be ReFreSH 

accredited and the

regulated pests 

associated with the 

listed seed taxa. The 

sample below lists 

descriptions of pest 

categories mitigated 

by the listed risk 

management 

measure(s). When 

part of an actual 

SHMP, the 

descriptions would 

be replaced by 

specific pest names.

Determine the Critical 

Control Point (CCP): 

Where and/or when risk 

management measures 

are applied.

A Hazard is an identified 

area or process that could 

potentially introduce a 

pest or pathogen. Or if a 

pest or pathogen is 

prevalent, could result in 

dispersal or spread of the 

pest or pathogen without 

mitigation.

Determine the steps taken

to mitigate the hazard/risk 

at the CCP. List or 

describe any internal 

procedures used or 

needed for the SHMP. List 

any other procedures or 

documents used to 

determine appropriate 

risk management. 

Regulatory requirements, 

compliance agreements, 

internal quality 

management procedures, 

extension information are 

examples. Examples of 

pest types and possible 

risk management 

measures for them are 

listed in Table 3 in this 

appendix.

Describe the procedures 

to verify that risk 

management measures 

are implemented and 

effective.

Define who is 

responsible for 

implementing 

and verifying 

risk 

management 

measures.

Define any 

training requirements or specific 

knowledge that 

may be needed to 

implement risk 

management. All 

workers should 

receive general 

ReFreSH principles 

training.

List the records used to 

document all SHMP 

requirements are met. 

(e.g. spraying records, trap 

records, etc.) 
ReFreSH Participant Manual 07/01/2021 A- 3

Table 2. Risk Evaluation/Hazard Analysis Example

Seed Health Management Plan Information ReFreSH Manual Information

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

Commodity B.2. Pre-planting 

Describe pre-plant facilities assessment and procedures that prevent or mitigate pest introduction from the environment into the production site(s).

Pest(s)

B. 2.1. Site Selection and 

Preparation

Add any additional factors and select any of the following as appropriate for the 

commodity / pest combination. 

• Contaminated or 

infested soil (field grown 

crops)

• Production in pest free 

areas, pest free places of 

production, pest free 

production sites, low pest 

prevalence

• Surveys/inspection/ 

monitoring (e.g., 

trapping)

• Name / Title 

of 

responsible 

person

• Knowledge of IPPC 

standards for pestfree concepts

• Survey / 

Inspection 

records

• Soil treatments • Soil sampling / testing / 

inspection for soilborne 

pests

• Pesticide 

application; 

soilborne pest 

control

• Pesticide 

application 

records

• Soil sampling / testing / 

inspection for soilborne 

pests

• Inspection/test results • Soil sampling; 

results 

interpretation

• Inspection / 

test results

• Contaminated water 

sources

• Use clean water source 

(e.g., sealed deep well, 

municipal water)

• Verify source as part of 

audits

• Treat water to sterilize 

(e.g., boil, UV, chlorine, 

etc.)

• Review treatment 

records

• Water treatment 

methods and 

equipment training

• Water 

treatment 

records
ReFreSH Participant Manual 07/01/2021 A- 4

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

• Sample / test water for 

waterborne pests of 

concern

• Review test results • Water sampling; 

results 

interpretation

• Water test 

results

• Site has a history of host 

crops and/or pests

• Use crop rotation and / or 

fallow periods

• Review cropping records • Cropping 

history

• Endemic pests present • Production in pest free 

areas, pest free places of 

production, pest free 

production sites, low pest 

prevalence

• Surveys / inspection / 

monitoring (e.g., 

trapping)

• Survey / inspection 

methodology; IPM; 

pesticide 

application; 

knowledge of IPPC 

standards for pestfree concepts.

• Survey / 

Inspection 

records

• Pesticide / 

treatment 

application 

records

• Field management: pest 

monitoring, pesticide 

treatment, biological 

control

• Regulated pests present • Production in pest free 

areas, pest free places of 

production, pest free 

production sites, low pest 

prevalence

• Field management: pest 

monitoring, pesticide 

treatment, biological 

control

• Inadequate isolation 

distance from other 

crops produced on-site 

or nearby

• Ensure production site is 

sufficiently isolated from 

other crops produced onsite or nearby

• Maintain a host-free buffer 

around the production site 
ReFreSH Participant Manual 07/01/2021 A- 5

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

to prevent infestation from 

other crops produced onsite or nearby

• Weeds present in 

production field

• Inspection and field 

management through 

herbicide treatment or 

physical destruction (e.g., 

plowing)

• Surveys / inspection / 

monitoring 

• Survey/inspection 

methodology; 

weed control; 

pesticide 

application 

• Weed control in borders 

and adjacent fields is 

absent or inadequate

• Inspection and border 

weed management through 

herbicide treatment or 

physical destruction (e.g., 

plowing)

• Volunteer plants and 

host debris from earlier 

growing seasons not 

properly removed

• Inspection and destruction 

/ removal of volunteers

with herbicide treatment or 

physical destruction (e.g., 

plowing)

• Potential disease vectors 

present

• Production in pest free 

areas, pest free places of 

production, pest free 

production sites, low pest 

prevalence

• Surveys / inspection / 

monitoring (e.g., 

trapping)

• Field management: pest 

monitoring, pesticide 

treatment, biological 

control

• Worker hygiene and 

sanitation not properly 

maintained

• Workers trained on proper 

sanitation and hygiene 

protocols

• Review training records • Sanitation and 

hygiene training

• Training 

records
ReFreSH Participant Manual 07/01/2021 A- 6

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

• Use of disinfectant 

footbaths and handwashing 

stations

• Review disinfectant logs 

for footbaths and 

handwashing stations

• Sanitization 

records and 

disinfectant 

logs • Tool/equipment 

(including tractors and 

other field equipment) 

sanitation not properly 

maintained

• All tools and equipment 

including tractors and field 

equipment are properly 

washed and sanitized prior 

to entering production site

• Review logs for cleaning 

and sanitization

• Authorized access not 

properly maintained

• Site is gated and/or fenced 

or access otherwise 

physically limited

• Verify presence as part 

of audits

• Use signs to indicate access 

is limited to authorized 

personnel

For protected culture crops (including transplant houses):

• Structure sanitization 

prior to use or between 

growing seasons/cycles 

not properly maintained

• All surfaces are 

cleaned/sanitized prior to 

use or between growing 

cycles/seasons; all weeds 

and plant debris removed

• Review logs for cleaning 

and sanitization

• Sanitation and 

hygiene training

• Sanitization 

records and 

disinfectant 

logs

• Structure integrity prior 

to use or between 

growing seasons/cycles 

not properly maintained

• Structure is inspected prior 

to use or between growing 

cycles/seasons and any 

broken glass or tears are 

repaired immediately

• Review inspection / 

repair reports; inspect 

structure as part of 

audits

• Inspection 

reports and 

repair 

records

• Seed beds not properly 

cleaned / sanitized 

• Beds cleaned to remove 

debris and growing medium 

is sterilized 

• Review logs for cleaning 

and sanitization

• Sanitation and 

hygiene training

• Sanitization 

records and 
ReFreSH Participant Manual 07/01/2021 A- 7

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

• Beds cleaned and sanitized; 

growing medium is 

replaced with new or 

sterilized growing medium

disinfectant 

logs

• Contaminated growing 

media used in transplant 

seed beds/pots/trays

• Use only new, unused 

and/or sterilized growing 

media in beds/pots/trays

• Review records for 

growing media source 

and/or sterilization

• Contaminated 

transplant containers 

used

• Use only new, unused 

and/or sterilized transplant 

containers

• Review records for 

transplant containers 

source and/or 

sterilization

• Growing media and 

containers not stored 

properly to avoid pest 

contamination

• Store media and containers 

to safeguard them from 

contamination/infestation 

by pests, soil, contaminated 

water, etc.

• Inspect storage 

conditions as part of 

audits

• Tool/equipment 

sanitation not properly 

completed

• All tools and equipment are 

properly washed and 

sanitized prior to entering 

production site

• Review logs for cleaning 

and sanitization

B.2.2. Seed and Plant 

Inputs 

Add any additional factors and select any of the following as appropriate for the 

commodity / pest combination

• Non-certified/untested 

seeds are inadvertently 

planted; pest detections 

later in the process 

cannot be traced back to 

origin

• Identification and tracking

procedures

• Review seed source 

(import), certification 

records

• Familiarity with 

and/or training in 

entity’s inventory 

control system

• Seed source 

(import), 

certification 

and testing 

records
ReFreSH Participant Manual 07/01/2021 A- 8

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

• Non-certified or 

untested seeds are 

infested and planted

• Seed health testing /

certification of seed lots

• Review certification and 

testing records

• Familiarity with 

seed certification 

systems

• Inappropriate, 

improperly applied or 

missing seed treatments 

result in diseased plants 

• Appropriate seed

treatment applications

• Monitor seed 

treatments; review seed 

treatment records

• Familiarity with or 

training in seed 

treatments and 

their application

• Seed 

treatment 

records

• Infected/infested 

transplants planted in 

the field

• Inspection or testing of

seedlings/transplants prior

to transplanting

• Review inspection / 

testing records for each 

transplant lot prior to 

planting 

• Familiarity / 

training of signs 

and symptoms of 

pests in 

transplants; 

familiarity / training 

in inspection / 

sampling /testing 

methodology and 

interpretation of 

results

• Inspection / 

testing 

records

• Diseased or

contaminated seeds,

plants, growing

media or containers

infest, infect or

contaminate healthy

seeds or plants

• Diagnosis of diseased or

symptomatic plants, and

disposal of contaminated

seeds, plants, growing

media and containers by

APHIS–approved methods

• Review records for 

diagnosis and 

destruction of 

diseased/contaminated 

materials

• Experience / 

training / or access 

to expertise in 

diagnostics; 

familiarity / training 

for approved 

destruction 

/devitalization 

methods

• Diagnostic 

and 

destruction / 

devitalization 

records

B.3. Pre-harvest
ReFreSH Participant Manual 07/01/2021 A- 9

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

B.3.1. Production Add any additional factors and select any of the following as appropriate for the 

commodity / pest combination

• Unauthorized visitors to 

the production site may 

introduce pests

• Maintain authorized

access to site; use signs to

indicate access is limited

to authorized personnel

• Monitor visitor /activity 

records for production 

site

• Awareness of 

authorized access 

list

• List of 

authorized 

personnel

• Worker hygiene and 

sanitation not properly 

maintained

• Workers trained on proper 

sanitation and hygiene 

protocols

• Review training records; 

monitor hygiene and 

sanitation

• Sanitation and 

hygiene training

• Training 

records

• Use of disinfectant 

footbaths and 

handwashing stations

• Review disinfectant logs 

for footbaths and 

handwashing stations

• Sanitization 

and cleaning 

records and 

disinfectant 

logs • Tool/equipment 

sanitation and washing 

not properly completed 

resulting in 

contamination

• Tool/equipment (including

planter or tractor)

sanitation

• Review logs for cleaning 

and sanitization

• Production sites infested 

/ infected during 

growing season

• Regular crop inspections

of all plants including

males (pollinator) plants

• Review crop inspection 

records

• Familiarity / 

training in field 

inspection and 

signs / symptoms 

of pests 

• Crop 

inspection 

reports

• Diseased or

contaminated plants

infest, infect or

contaminate healthy

plants

• Diagnosis and disposal of

symptomatic plants by

approved methods

• Review records for 

diagnosis and 

destruction of 

diseased/contaminated 

materials

• Experience / 

training or access 

to expertise in 

diagnostics; 

familiarity / 

training for 

approved 

• Diagnostic 

and 

destruction / 

devitalization 

records
ReFreSH Participant Manual 07/01/2021 A- 10

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

destruction 

/devitalization 

methods

• Presence of vectors may 

result in the 

introduction and/or 

spread of pests

• Monitoring for vectors • Survey / inspect/ 

monitor for the 

presence of vectors

• Experience / 

training or access 

to expertise in 

identifying vector 

species; 

knowledge 

training in survey 

/ inspection 

methods

• Survey / 

inspection 

records

• Production site 

infestation during 

production cycle

• Management of pests with

appropriate pesticide

(chemical or biological)

applications and cultural

control practices (e.g.,

mulching, screens over

access points in

greenhouses)

• Survey / inspect/ 

monitor for the 

presence of pests 

• Survey/inspection 

methodology; 

Integrated pest 

management; 

pesticide 

application 

• Survey / 

inspection 

records; 

pesticide 

application 

records

• Contaminated water 

sources

• Use clean water source 

(e.g., sealed deep well, 

municipal water)

• Verify source as part of 

audits

• Irrigation creates 

favorable environment 

for pest populations

• Manage irrigation

frequency and type (e.g.,

drip vs. overhead) to

reduce moisture

conditions favorable to

pest populations

• Monitor production site 

moisture levels

• Knowledge of pest 

biology / moisture 

requirements
ReFreSH Participant Manual 07/01/2021 A- 11

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

• Weed control in 

production site and 

borders is absent or 

inadequate

• Weed control within and

surrounding the

production location (field,

structure, etc.)

• Surveys / inspection / 

monitoring 

• Survey/inspection 

methodology; 

weed control; 

pesticide 

application 

• Survey / 

Inspection 

records; 

pesticide / 

treatment 

application 

records

• Non-certified/untested 

seeds are inadvertently 

planted; pest detections 

cannot be traced back to 

origin or traced forward 

to customers

• Identification and tracking

procedures

• Review seed source 

records; ensure proper 

labelling

• Familiarity with 

and/or training in 

entity’s inventory 

control system

• Inventory 

tracking 

records

B.3.2. Seed Harvest Describe procedures used to minimize seed contamination during harvesting and drying

at the production site(s).

• Pests present in 

harvested seeds if 

harvested when pest 

population high or 

plants at susceptible 

stage for seed 

infestation

• Harvest criteria (maturity,

timing) for the crop

• Monitor pest 

populations and crop 

maturity

• Familiarity / 

training in 

epidemiology crop 

phenology

• Harvest 

dates/ pest 

populations

• Harvested seeds and 

equipment 

contaminated by surface 

contaminants on 

harvested fruit

• If applicable, pre-harvest

fruit washing or sanitizing

procedures

• Review logs for cleaning 

and sanitization

• Sanitation and 

hygiene training

• Sanitization 

and cleaning 

records and 

disinfectant 

logs
ReFreSH Participant Manual 07/01/2021 A- 12

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

• Seeds contaminated 

during extraction

• Harvest/seed extraction

location (e.g., within a

facility, in the field)

• Review harvest 

/extraction records

• Harvest 

/extraction 

records

• Unfavorable weather 

results in seed 

contamination

• Avoid weather conditions

(e.g., rain, dew) at harvest

that favor disease

development /

contamination

• Review harvest records • Familiarity / 

training in 

epidemiology

• Infected seeds 

harvested

• Visual inspection of plants

and fruit prior to harvest

• Surveys / inspection / 

monitoring

• Familiarity / 

training in field 

inspection and 

signs / symptoms 

of pests 

• Inspection 

records

• Harvested seeds 

contaminated as a result 

of poor worker hygiene 

and sanitation

• Workers trained on 

proper sanitation and 

hygiene protocols

• Review training records; 

monitor hygiene and 

sanitation

• Sanitation and 

hygiene training

• Training 

records

• Harvested seeds 

contaminated by 

improper equipment 

and tool cleaning and 

sanitization

• Harvest equipment and

tool sanitation and/or

cleaning

• Review logs for cleaning 

and sanitization

• Sanitization 

and cleaning 

records and 

disinfectant 

logs

• Seeds contaminated 

during drying

• If applicable, seed drying

location

• Review harvest records • Harvest 

records

• Harvested seeds 

contaminated by 

improper equipment 

cleaning and sanitization

• Drying equipment

sanitation

• Review logs for cleaning 

and sanitization

• Sanitation and 

hygiene training

• Sanitization 

and cleaning 

records and 
ReFreSH Participant Manual 07/01/2021 A- 13

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

• Contaminated seed 

containers used

• Use of new or sanitized

seed containers/bags

• Review records for seed 

container source and/or 

sterilization

disinfectant 

logs

• Pest detections cannot 

be traced back to origin 

or traced forward to 

customers

• Identification and tracking

procedures

• Review seed source 

records; ensure proper 

labelling

• Familiarity with 

and/or training in 

entity’s inventory 

control system

• Inventory 

tracking 

records

B.4. Post-harvest 

B.4.1. Conditioning and 

Treatment 

Describe the procedures used to reduce the presence of seed-associated pests during 

seed cleaning, conditioning, sizing and packaging.

• Pest detections cannot 

be traced back to origin 

or traced forward to 

customers

• Identification and tracking

procedures

• Review seed source 

records; ensure proper 

labelling

• Familiarity with 

and/or training in 

entity’s inventory 

control system

• Inventory 

tracking 

records

• Missing / misapplied / 

incorrect seed 

treatments allow 

infestation / infection of 

seeds / subsequent 

plants

• Seed treatments • Monitor seed

treatments; review seed 

treatment records

• Familiarity with or 

training in seed 

treatments and 

their application

• Seed 

treatment 

records

• Seeds contaminated as a 

result of improper 

equipment and tool 

cleaning and sanitization

• Seed operations

equipment and tool

sanitization and/or

cleaning

• Review logs for cleaning 

and sanitization

• Sanitation and 

hygiene training

• Sanitization 

and cleaning 

records and 

disinfectant 

logs

• Potential contamination 

from remnant and 

• Proper disposal of all

remnant and unusable

seeds and debris

• Review disposal records • Sanitation and 

hygiene training;

familiarity / 
ReFreSH Participant Manual 07/01/2021 A- 14

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

unusable seeds and 

debris

training for 

approved 

destruction 

/devitalization 

methods

• Disposal and 

destruction 

• Potential contamination records

of clean seed lots and 

equipment from 

contaminated seeds

• Disposal of all seeds found

to be contaminated with

regulated pests in

accordance to regulatory

guidelines

• Harvested seeds 

contaminated as a result 

of poor worker hygiene 

and sanitation

• Worker sanitation and

hygiene

• Review training records; 

monitor hygiene and 

sanitation

• Sanitation and 

hygiene training

• Training 

records

B.4.2. Handling and 

Storage 

Describe procedures to prevent the introduction and spread of seed-associated pests 

during post-harvest handling and storage. The measures should address all stages in the 

process, i.e., filling, handling, storage, and distribution of containers between the 

entity’s facilities or from a vendor to the entity’s facilities.

• Pest detections cannot 

be traced back to origin 

or traced forward to 

customers; 

phytosanitary status of 

seeds is not maintained

• Identification and tracking

procedures

• Review tracking and 

tracing records; ensure 

proper labelling

• Familiarity with 

and/or training in 

entity’s inventory 

control system

• Inventory 

tracking 

records

• Infected seeds 

distributed in seed 

supply system

• Untested seeds are not

commingled with tested

seed inventory

• Review testing and 

tracking records; ensure 

proper labelling

• Inventory 

tracking / 

testing 

records

• Storage conditions allow 

seeds to become 

contaminated / infested 

/ infected

• Seeds stored in closed

containers under

monitored warehouse

conditions of controlled

• Monitor storage 

conditions

• Familiarity with 

storage protocols

• Storage 

condition 

records
ReFreSH Participant Manual 07/01/2021 A- 15

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

temperature and humidity

• Seeds contaminated as a 

result of improper 

warehouse cleaning and 

sanitization or remnant 

and unusable seeds and 

debris

• Warehouse sanitation

including regular cleaning,

immediate clean-up of seed

spills, removal of waste or

unused seeds

• Review logs for cleaning 

and sanitization; review 

disposal records

• Sanitation and 

hygiene training

• Sanitization 

and cleaning 

records and 

disinfectant 

logs

• Disposal and 

destruction 

records

• Harvested seeds 

contaminated by 

improper equipment 

cleaning and sanitization

• Equipment and tool

sanitization and/or cleaning

• Review logs for cleaning 

and sanitization

• Sanitization 

and cleaning 

records and 

disinfectant 

logs

• Harvested seeds 

contaminated as a result 

of poor worker hygiene 

and sanitation

• Worker hygiene and

sanitation

• Review training records; 

monitor hygiene and 

sanitation

• Training 

records

B.4.3. Seed Testing Describe the seed health testing procedures and methods used to ensure that the 

entity’s seed supply system is free of regulated pests.

• Untested seeds are 

released into seed 

supply system; pest 

detections cannot be 

traced back to origin or 

traced forward to 

customers; 

phytosanitary status of 

seeds is not maintained

• Identification and tracking

procedures

• Review testing, tracking 

and tracing records; 

ensure proper labelling

• Familiarity with 

and/or training in 

entity’s inventory 

control system

• Familiarity

with and/or 

training in 

entity’s 

inventory 

control 

system
ReFreSH Participant Manual 07/01/2021 A- 16

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

• Improper seed testing 

results in failure to 

detect pests

• Accreditation or

authorization status of seed

health testing laboratories

• Review authorization 

and audit records

• Familiarity with 

authorization/ 

accreditation 

requirements

• Authorization 

and audit 

records

• Authorization status of

methods used for seed

health testing

• Use of seed sampling

methods described by the

International Seed Testing

Association (ISTA) or the

Association of Seed Control

Officials (AASCO)

• Familiarity with 

approved seed 

sampling methods

• Seed 

sampling 

records

• Use of official seed

samplers, if applicable

• Seeds contaminated by 

improper equipment 

cleaning and 

sanitization; test results 

impacted by incorrect 

sample size resulting 

from improper 

calibration

• Seed sampling equipment

cleaning, sanitization and

calibration 

• Review logs for 

cleaning and 

sanitization and 

calibration

• Sanitation and 

calibration training

• Sanitization,

cleaning and 

calibration 

records 

• Seeds contaminated by 

previously used sample 

bags

• Use of new sample

collection bags

• Review as part of audits • Sanitation training

• Seeds contaminated as a 

result of improper 

laboratory / greenhouse 

cleaning and sanitization

• Laboratory and greenhouse 

sanitation 

• Review logs for 

cleaning and 

sanitization

• Sanitation training • Sanitization,

cleaning 

records 

• Seeds contaminated by 

improper equipment 

• Laboratory equipment and 

tool cleaning, sanitization, 

• Review logs for 

cleaning and 

• Sanitization,

cleaning and 
ReFreSH Participant Manual 07/01/2021 A- 17

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

cleaning and 

sanitization; test results 

impacted by improper 

equipment calibration

calibration and 

maintenance

sanitization and 

calibration

calibration 

records 

• Seed test results 

compromised as a result 

of using inappropriate 

methods or poor 

laboratory practices

• Training of laboratory staff 

on appropriate testing 

methodologies and good 

laboratory practices

• Review test 

methodologies and 

laboratory practices

• Training in test 

methods and good 

laboratory 

practices

• Work 

instructions 

for 

laboratory 

testing

• Improper data 

interpretation results in 

incorrect test results

• Standard data 

interpretation for 

authorized methods

• Review data 

interpretation

• Training in test 

methods and data 

interpretation

• Potential contamination 

from remnant seeds and 

debris

• Remnant seeds and debris 

properly disposed of in 

accordance with local 

regulations and good 

laboratory practices

• Review logs for 

cleaning and 

sanitization; review 

disposal records

• Sanitation and 

hygiene training

• Sanitization 

and cleaning 

records and 

disinfectant 

logs; 

disposal and 

destruction 

records

B.5. Distribution and Transport

Describe procedures used to mitigate seed-associated pests in seeds that are distributed outside of the

accredited entity facility. Procedures used to meet international phytosanitary regulatory requirements

must be included.

• Pest detections cannot 

be traced back to origin 

or traced forward to 

customers; 

• Identification and

tracking procedures

• Review tracking and 

tracing records; ensure 

proper labelling

• Familiarity with 

and/or training in 

entity’s inventory 

control system

• Familiarity

with and/or 

training in 

entity’s 

inventory 
ReFreSH Participant Manual 07/01/2021 A- 18

Commodity 

 Pest

Manual 

section

Critical Control 

Point 

Risk / Hazard Risk Management 

Measures

Monitoring / 

Verification

Responsible 

Person

Training / 

Knowledge

Records

phytosanitary status of 

seeds is not maintained

control 

system

• Noncompliant seeds are 

released

• Entity’s compliance

with seed quality

release criteria for

customer, market and

country import

requirements

• Review seed quality 

records

• Familiarity with 

entity’s seed 

quality standards

• Release 

records

• Seeds contaminated in 

transit

• Safeguarding measures

to maintain shipment

integrity

• Monitor packing and 

shipping conditions

• Familiarity with 

safeguarding 

methods

• Shipping 

records
ReFreSH Participant Manual 07/01/2021 A- 19

Table 3. Examples of pest types and possible risk management measures for 

them

Pest Type Risk Management Measures

Multiple pest 

categories

• Use crop rotation and / or fallow periods

• Production in pest free areas, pest free places of production, pest free production 

sites, areas of low pest prevalence

• Field management: pest monitoring, pesticide treatment, biological control

• Ensure production site is sufficiently isolated from other crops produced on-site or 

nearby

• Maintain a host-free buffer around the production site to prevent infestation from 

other crops produced on-site or nearby

• Workers trained on proper sanitation and hygiene protocols

• Use of disinfectant footbaths and handwashing stations

• All tools and equipment including tractors and field equipment are properly washed 

and sanitized prior to entering production site

• Site is gated and/or fenced or access otherwise physically limited

• Use signs to indicate access is limited to authorized personnel; maintain authorized 

access to production site

• All surfaces are cleaned/sanitized prior to use or between growing cycles/seasons; 

all weeds and plant debris removed

• Inspection and destruction / removal of volunteers with herbicide treatment or 

physical destruction (e.g., plowing)

• Identification and tracking procedures

• Seed health testing / certification of seed lots

• Appropriate seed treatment applications

• Inspection or testing of seedlings/transplants prior to transplanting

• Regular crop inspections of production plants

• Diagnosis of diseased or symptomatic plants, and disposal of contaminated

seeds, plants, growing media and containers by APHIS–approved methods

• Manage irrigation frequency to reduce moisture conditions favorable to pest

populations

• Harvest criteria (maturity, timing) for the crop

Soilborne pests • Production in pest free areas, pest free places of production, pest free production 

sites, low pest prevalence

• Soilless growing media

• Soil treatments

• Soil sampling / testing / inspection for soilborne pests

Waterborne pests • Use clean water source (e.g., sealed deep well, municipal water)

• Treat water to sterilize (e.g., boil, UV, chlorine, etc.)

• Sample / test water for waterborne pests of concern
ReFreSH Participant Manual 07/01/2021 

A- 20

Pest Type Risk Management Measures

Weed pests and 

pests with weed 

hosts

• Inspection and field management through herbicide treatment or physical 

destruction (e.g., plowing)

• Production in pest free areas, pest free places of production, pest free production 

sites, low pest prevalence

Pests with vectors 

(e.g., arthropods, 

nematodes)

• Monitoring for vectors

• Field management: pest monitoring, pesticide treatment, biological control

Pests with airborne 

or rain-splashed 

spores; arthropod 

pests; pests with 

arthropod vectors

• Structure is inspected prior to use, during production and between growing 

cycles/seasons and any broken glass or tears are repaired immediately

Pests capable of 

surviving as surface 

contaminants, 

growing media 

contaminants or 

saprophytes, 

soilborne pests

• Beds cleaned to remove debris and growing medium is sterilized 

• Beds cleaned and sanitized; growing medium is replaced with new or sterilized 

growing medium

• Use only new, unused and/or sterilized growing media in beds/pots/trays

• Use only new, unused and/or sterilized transplant containers

• Store media and containers to safeguard them from contamination/infestation by 

pests, soil, contaminated water, etc.

• All tools and equipment are properly washed and sanitized prior to entering 

production site