PI-005: Chapter 6 - Nuclear Stock Inspection

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Table of Contents

6.1 Objective

Nuclear stock class seed potatoes (nuclear stock) are produced from pathogen-tested tissue culture plantlets under aseptic and/or protected environment conditions. The objective of a nuclear stock audit or inspection is to confirm that the production process meets the requirements for the different phases of nuclear stock production described in the Seeds Regulations Part II and CFIA directive D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes.

This chapter of the inspection manual will provide the inspector with an understanding of the appropriate inspection/audit procedures for the various phases of nuclear stock production. In addition to this chapter of the inspection manual, inspection staff should be familiar with the Canadian Food Inspection Agency (CFIA) policy directive D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes pertaining to nuclear stock production, inspection/audit and certification.

Note: A CFIA inspector must audit production practices and inspect plant material at facilities used for the production or initiation of Nuclear Stock class seed potatoes at least once a year during active crop production.

6.2 Definitions

Aseptic environment:
A container and process which excludes microorganisms that are capable of causing contamination or infection;
Generation:
A cycle of production spanning from the planting of the potato propagules to the harvest of tubers;
Initiation:
The establishment of pathogen-tested potato propagules in an aseptic environment (tissue culture);
Laboratory tests:
Tests that are conducted in a laboratory that is approved under the Agency Laboratory Approval Program or in a laboratory that can reasonably be considered to be equivalent to a laboratory approved under that program (Seeds Regulations Part II);
Maintenance:
The process of keeping a very limited number (i.e. 5-20) of pathogen-tested potato propagules of a specified variety in an aseptic environment (through tissue culture techniques);
Multiplication:
The process of multiplying pathogen-tested potato propagules in an aseptic environment (test tube or similar container) or in a protected environment (greenhouse, screenhouse or growth chamber);
Nuclear stock (seed potato):

Seed potatoes that are:

a. produced from potato tissue culture material which has been tested and found free of bacterial ring rot, PSTVd and viruses,

b. laboratory tested within 12 months prior to the completion of the multiplication process and found free of bacterial ring rot, PSTVd and viruses,

c. produced in an aseptic or protected environment,

d. visibly free from varietal mixtures,

e. free from pathogenic bacteria or viruses, saprophytic contamination or other symptoms of diseases that could affect the quality of the material, and

f. if produced in a protected environment, (i) inspected by an inspector at least once during the growing period, and (ii) grown in a medium that has not been previously used (Seeds Regulations Part II);

Plantlet:
A small potato cutting or rooted potato cutting produced in an aseptic environment using in vitro propagative techniques;
Propagule:
Any part of an organism capable of independent growth;
Protected environment:
A facility for which there are appropriate procedures and physical barriers to prevent the entry of plant pathogens and insects (Seed Regulations Part II);
Seed potato:
A tuber or any part of a tuber, or nuclear stock, that is certified under these regulations for seed reproduction purposes (Seeds Regulations Part II).

6.3 Acronyms

  • BRR: Bacterial Ring Rot;
  • PLRV: Potato Leaf Roll Virus;
  • PMTV: Potato Mop-Top Virus;
  • PMRA: Pest Management Regulatory Agency (Health Canada);
  • PSTVd: Potato Spindle Tuber Viroid;
  • PVA: Potato Virus A;
  • PVM: Potato Virus M;
  • PVS: Potato Virus S;
  • PVX: Potato Virus X;
  • PVY: Potato Virus Y;
  • PotLV: Red LaSoda virus, also known as potato latent virus.

6.4 Overview of Nuclear Stock Production

The majority of seed potatoes produced in Canada originate from nuclear stock class seed potatoes. Nuclear stock is produced under aseptic conditions from disease-tested tissue culture propagative material. Any potato material can be initiated and certified as nuclear stock, provided every element of the appropriate standard is met. Seed potatoes produced from nuclear stock can remain in the Canadian seed potato certification program for up to seven years. Each year, pursuant to the Seeds Regulations Part II, the seed drops a class within the classification system. This flush-through system minimises the risk of disease build up in Canada's seed potatoes and is the foundation for a reliable, high quality, seed potato certification system. Carefully regulated certification of nuclear stock is paramount to the phytosanitary integrity of all other classes of seed potatoes.

6.5 Phases of Nuclear Stock Production

There are three distinct phases in the production of nuclear stock:

  • Initiation;
  • Maintenance;
  • Multiplication;
    • In an aseptic environment,
    • In a protected environment.

This chapter will describe the differences between these phases and their inspection/audit procedures.

6.6 Certification of Nuclear Stock Class Seed Potatoes

This section focuses on the physical inspection/audit procedures pertaining to nuclear stock production and certification. Therefore, to ensure continuity while avoiding duplication, reference should be made to both CFIA policy directive D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes, and the Seeds Regulations Part II for a complete overview of the regulatory requirements relating to the production, transfer and certification of nuclear stock class seed potatoes.

6.6.1 Application and Supporting Documentation

With the exception of the Maintenance phase, an application for certification must be submitted to the local CFIA office using the Application for Seed Potato Crop Inspection - Grower's Declaration (CFIA/ACIA 1317). All varieties/clones produced on a farm unit, including table stock and processing lots, must be declared on the application form. It is recommended to submit a separate application to the CFIA for each type of seed potato production and to clearly identify the method of production being utilized. For each new crop produced in a protected environment, the facility must be cleaned and disinfected, and must meet the requirements as set out in D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes.

6.6.1.1 Nuclear Stock Produced in an Aseptic Environment

If material intended for certification as nuclear stock is produced in an aseptic environment, the application for certification must be filed and a Growing Crop Certificate- Seed Potato (CFIA/ACIA 1318) must be issued before the material is transferred to a new owner/grower, transferred into a protected environment, or planted in a field.

6.6.1.2 Nuclear Stock Produced in a Protected Environment

If material intended for certification as nuclear stock is produced in a protected environment, the application for certification must be filed within thirty days after the crop(s) have been planted in the protected environment. Note, however that the grower must notify the local CFIA office 10 working days prior to planting, in order to allow sufficient time for a pre-planting inspection/audit to be scheduled if the CFIA office determines that one is necessary.

6.6.2 Completion of the Application for Nuclear Stock Inspection

To apply for an inspection of nuclear stock, the grower must submit a completed Application for Seed Potato Crop Inspection - Grower's Declaration (CFIA/ACIA 1317). It must include the following information and be accompanied by supporting documentation which provides evidence as to the origin of each crop planted:

  • The applicant's name and address;
  • The variety(ies)/clone(s) being initiated/multiplied;
  • The origin of the variety(ies)/clone(s) being initiated/multiplied (i.e., whether self-initiated or obtained from other sources. If received from other sources an official Nuclear Stock Certificate- Seed Potato Program (CFIA/ACIA 4351) or equivalent is required) e.g. import permit, Certificate of Authorization, North American Certified Seed Potato Health Certificate;
  • The date samples from each clone or variety were received by the CFIA-approved laboratory for testing. Copies of test results must be available, if requested by the CFIA;
  • The certification number of the material being multiplied or, in the case of initial material, the origin of the material;
  • The type of production (i.e., aseptic or protected environment);
  • The physical location of the production environment;
  • A copy of the floor plan for the crop(s) if produced in a protected environment. A floor plan should indicate the location of each variety or clone; and
  • Each page of the submitted application form should be signed and dated by the applicant.

Following submission of the application, any changes or modifications to the content of the CFIA's copy of the application must be initialled and dated by the original applicant.

6.6.3 Fees

The applicable fees for seed potato certification are currently $50.00 per application and $20.00 for the first hectare or portion thereof, and an additional $20.00 for each full hectare beyond the first. The fees and all applicable taxes must be made payable to "The Receiver General for Canada". All fees must be paid in full at the time the application is submitted to the CFIA. Fees for inspection and certification services are inclusive for activities such as crop inspections, tuber inspection and issuance of domestic certificates. If multiple crops are produced in a protected environment, applicable fees are charged for the initial application ($50.00) and per hectare of growing area ($20.00 per ha) only. Fees for the application and fees per hectare for a second crop produced in a greenhouse, protected environment, are charged even if certificate numbers are concurrent.

In the event that there is an outstanding balance and fees are owing after all inspections/audits have been completed, no growing crop certificates, tags, or bulk movement certificates should be issued until the outstanding amount is settled.

For more information on plant health fees consult the Canadian Food Inspection Agency Fees Notice. For more information on fees or refunds for fields withdrawn from certification refer to D-95-13: Seed Potato Certification Program - Submission/Refund of Fees for Field Inspection.

Note: A grower submitting separate applications for field-grown crops and crops produced in a protected and/or aseptic environment with the intention of operating them as separate farm units (i.e., with different grower numbers) is expected to pay the applicable fees for each application.

6.6.4 Testing Requirements

Each crop under production must have valid disease testing results at all times during the multiplication process, with the exception of micro-tuber production, where valid disease testing results are required at the initiation of the micro-tuber production cycle. The testing results for the viruses, viroid and bacteria listed in section 6.6.4.1, 6.6.4.2 and 6.6.4.3 must be negative for CFIA to consider proceeding with the certification of the material put forward by a grower as Nuclear Stock seed potato.

Testing results are valid for a period of 12 months commencing from the date that the sample was received for testing at the approved laboratory. The date of testing and the date of sample submission to the approved laboratory for each crop/lot should be noted. The results and dates should match the official testing results provided directly to the CFIA by the CFIA-approved laboratory that carried out the tests. All samples taken for required pathogen testing must be collected by/or under the supervision of a CFIA inspector.

For details on testing rates and the timing for the collection of representative samples, see section 6.7.1 (initiation), 6.7.2 (maintenance), 6.7.3 (multiplication in an aseptic environment) and 6.7.4 (multiplication in a protected environment).

6.6.4.1 Viruses

Each crop must have been found free from PVA, PVS, PVM, PVY, PVX, PLRV, PMTV and PotLV.

Testing for PMTV and PotLV is required only for the initiation phase.

If a CFIA-approved laboratory confirms the presence of one of the virus mentioned above, the infected variety/clone will not be eligible for certification as Nuclear Stock or certification as Nuclear Stock will be revoked. Depending on the % of plants infested within a variety/clone (crop), the crop may be assigned another class as seed potato i.e.; Elite, Foundation or Certified. However, generally the % of plants infested with a virus will likely be high and we will have to refuse certification as seed and the material should be discarded or subject to a virus freeing treatment.

6.6.4.2 Viroids

Each crop must have been found free from PSTVd.

If a CFIA laboratory or a CFIA-approved laboratory confirms the presence of PSTVd, the infected variety/clone will not be eligible for certification or certification will be revoked. All plant parts from any variety/clone that tests positive for PSTVd must be immediately removed from the facility.

6.6.4.3 Bacteria

Each crop must have been found free from Clavibacter michiganensis subsp. sepedonicus, the causal pathogen for BRR.

If the CFIA confirms the presence of C. m. subsp. sepedonicus, in a Nuclear Stock producing establishment, irrespective of the production phase or the type of establishment, the infested variety/clone is not eligible for certification or certification will be revoked. All other production in the affected facility will be subject to re-testing to verify freedom from C. m. subsp. sepedonicus and certification may be revoked of material that may have been contaminated.

6.7 Inspection and Audit Procedures

Once an Application for Seed Potato Crop Inspection - Grower's Declaration (CFIA/ACIA 1317) has been received and approved, the inspector assigned to the facility should become fully familiar with the information contained therein. The inspector should then contact the facility owner/operator to arrange a time for an inspection/audit. Inspectors should consider which phase of nuclear stock production is being utilised when planning and arranging inspection/audit times (the recommendations relating to inspection/audit of protected environments differ from other phases).

It is important to carefully and accurately record the information obtained from and observations made during inspections /audit. Forms designed specifically for nuclear stock inspection have been developed (CFIA/ACIA 5292, 5293, 5294 and the Application Form for Issuance of Nuclear Stock Tags and Certificates (CFIA/ACIA 5295)). Samples of these forms can be found in Appendix 6-1.

Inspection/audit of nuclear stock initiation, maintenance and production facilities should be carried out only by senior inspection staff (i.e., those that have several years of experience with the seed potato certification program and with the inspection and certification of seed potatoes).

6.7.1 Audit of a Nuclear Stock Initiation Facility

Audit of facilities producing Nuclear Stock class seed potatoes in an aseptic environment should take place during active production, in order for the inspector to observe propagation methods and verify that appropriate aseptic techniques are used. However, inspectors must remember that their own presence confers a phytosanitary risk to the aseptic environment. Therefore, the following guidelines should be adhered to, in order to minimise this risk.

Audit of aseptic environments must be the first audit of the day only. Under no circumstances whatsoever should an aseptic environment be audited after inspecting/auditing any lower classes of seed potatoes, or visiting any potato processing or storage facilities. Furthermore, vehicles should be washed before visiting an aseptic environment and any footwear must have been cleaned and disinfected (a spray bottle should be taken to the facility so that disinfection of footwear can take place immediately prior to entering the premises). Inspectors must also comply with the appropriate facility-specific procedures in order to maintain its phytosanitary integrity. These procedures may include wearing lab coats, disposable footwear covers and overalls. If, as is recommended, propagation is actively taking place during the audit, the cutting area should be observed from a distance no closer than is necessary to verify that aseptic techniques are used. Great care must be taken to ensure that inspectors themselves will not be the source of contamination or infection of nuclear stock propagative material, and this aspect cannot be over-emphasized.

An audit form specifically designed for reporting audit findings in a laboratory used to multiply material maintained in an aseptic environment has been developed: Nuclear Stock Aseptic Facility Inspection Report (CFIA/ACIA 5292)(For internal use only). This form is checklist-based and also serves as a reminder of all aspects that should be considered during the audit. An example of this form can be found in Appendix 6-1.5.

When conducting an audit of an initiation facility, inspectors should be aware of the following guidelines:

  • A copy of the Application for Seed Potato Crop Inspection - Grower's Declaration (CFIA/ACIA 1317) (For internal use only) submitted for the crops being inspected should accompany the inspector. During the inspection, it should be verified that the material being initiated matches the information shown on the application form. Any discrepancies should be clearly highlighted and rectified (Note: any modifications to the form must be initialled by the original applicant).
  • The inspector should confirm that the facility owner/operator is in possession of the following reference documents and that they are up to date:
  • The inspector should review the following documentation maintained by the grower:
    • A procedures manual
    • Copies of test results and sample submission dates
    • Propagation schedules
    • Distribution records
    • The information system described in policy directive D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes (Section 2.1.6).
  • Disease testing of plantlets must be carried out on a minimum of 2 plantlets per variety/clone during initiation. See section 6.7.3 and 6.7.4 for the sampling and testing rate during multiplication.

    The inspector should confirm that the facility uses recognised aseptic propagation procedures such as:
    • Working surfaces must be properly disinfected before use;
    • Cutting equipment must be properly disinfected between each tuber, plants or group of plants;
    • Cuttings must not come into contact with potentially contaminated surfaces; and
    • The facility should demonstrate how it verifies the effectiveness of its laminar flow benches and the frequency of filter changes (i.e., test certificates should be available).
  • The growth room must be inspected. A reasonable number of growth jars/test tubes should be inspected for general contamination and to assess apparent health of the propagative material. Hands should be washed before handling propagative containers. Care must be taken in order to avoid opening the jars or breaking their seals during the inspection. Inspectors should be familiar with the sections of D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes, relating to the presence of pathogens/contaminants.
  • The inspector should ensure that systems that maintain varietal integrity be in operation at the facility. These should be adequately demonstrated/explained by the producer during the audit.
  • The inspector should ensure that procedures for disposal of containers, if they show signs of bacterial or fungal contamination, exist. These procedures should be demonstrated/explained by the producer during the audit.
  • The inspector should confirm that clear labelling and separation exists between the material being produced for certification as Nuclear Stock class seed potatoes and any other material (maintenance; initiation).
  • If the facility does not comply with the Seeds Regulations Part II, or does not meet the requirements described in policy directive D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes, the grower must be notified immediately. A form has been developed for reporting non-compliance: Notification of Non-Compliance of Nuclear Stock Class Seed Potato Production Facility and Requirement for Corrective Action (CFIA/ACIA 5294)(For internal use only). An example of this form can be found in Appendix 6-1.7. This form should be completed and signed at the audit site, and a copy provided to the producer on the inspector's return to the office. A reasonable period of time should be given for the deficiency to be corrected, depending on the seriousness of the deficiency. A follow up audit must be carried out to ensure compliance, and the appropriate section of the form completed to confirm this. If, on a following audit, it is determined that requested corrective actions have not been implemented, a written notice should be sent to the applicant, and a copy provided to the Area Specialist for potatoes.
  • After all required audits of aseptic nuclear stock facilities have been completed, and the varieties present on the Application for Seed Potato Crop Inspection - Grower's Declaration (CFIA/ACIA 1317) (For internal use only) have passed inspection, then the crop has met all the requirements for its class. A Growing Crop Certificate - Seed Potato (CFIA/ACIA 1318)(For internal use only) shall be issued no later than 40 days after the final audit of the facility has been completed.

6.7.2 Maintenance of Nuclear Stock Class Seed Potatoes

Maintenance of Nuclear Stock class seed potatoes in an aseptic environment should be audited while performing the audit of initiation and/or multiplication operations. When conducting an audit of a facility maintaining Nuclear Stock class seed potatoes, inspectors should be aware of the following:

  • The inspector should confirm that the facility owner/operator is in possession of the following reference documents and that they are up to date:
  • The inspector should review the following documentation maintained by the grower if applicable:
    • A procedures manual
    • A maintenance schedule
    • The information system described in policy directive D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes (Section 2.1.6).

    Note: at this point it is important to verify the origin of all material being maintained. This is because, if the material being maintained has not been initiated within the maintaining facility, certification and disease testing must have been carried out prior to the material being transferred with other material under the maintenance phase.

  • Where maintenance takes place in a facility other than the initiating facility, inspectors should confirm that the material was certified as nuclear stock prior to transfer.
  • The inspector should confirm that the facility uses recognised aseptic propagation procedures when propagating stock for maintenance, noting carefully such points as:
    • All working surfaces must be appropriately disinfected before use
    • Cutting equipment must be properly disinfected between each plant
    • Cuttings should not come into contact with potentially contaminated surfaces
    • The facility should demonstrate how it verifies the effectiveness of its laminar flow benches and the frequency of filter changes (i.e., test certificates should be available).
  • The growth room should be verified. A reasonable number of growth jars should be verified for general contamination and to assess apparent health of the propagative material. Care must be taken in order to avoid opening the jars or breaking their seals during this part of the audit.
  • The inspector should ensure that systems that maintain varietal integrity be in operation at the facility. These should be adequately demonstrated/explained by the producer during the audit.
  • There are no requirements for regular disease testing during the maintenance phase.
  • The inspector should ensure that procedures for disposal of containers, if they show signs of bacterial or fungal contamination, exist. These procedures should be adequately demonstrated/explained by the producer during the audit.
  • If maintenance takes place in an initiating and/or multiplying facility, the inspector should confirm that clear labelling is evident and that separation exists between all material being produced for certification as nuclear stock seed potatoes and all other material.
  • Where maintenance takes place in a facility other than the initiating facility, the material must be certified as nuclear stock class seed potatoes prior to maintenance, possess disease testing results, be clearly labelled and be separated from any other material.
  • Disease testing for variety/clone(s) under maintenance must be carried out on a minimum of 2 plantlets per variety/clone.
  • Since maintenance of material in itself means that the material will not be presented for certification, there is no official application form or reporting requirements to be adhered to. Once the producer plans to initiate further nuclear stock from the maintained material, or begins to multiply it for certification, all requirements for initiation or multiplication, as described in the Seeds Regulations Part II and D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes will come into force and must be complied with.

6.7.3 Multiplication of Nuclear Stock in an Aseptic Environment

Audit of multiplication in an aseptic environment should take place during active production, in order that the inspector can observe propagation methods and verify that appropriate aseptic techniques are used. However, inspectors must remember that their own presence confers a phytosanitary risk to the aseptic environment. Therefore, the following guidelines should be adhered to, in order to minimise this risk.

Audit of multiplication of Nuclear Stock class seed potatoes in an aseptic environment must be the first audit of the day only. Under no circumstances whatsoever should such a facility be audited after inspecting any lower classes of seed potatoes, or visiting any potato processing or storage facilities. Furthermore, vehicles should be washed before visiting a facility conducting multiplication in an aseptic environment and any footwear must have been cleaned and disinfected (a spray bottle should be taken to the facility so that disinfection of footwear can take place immediately prior to entering the premises). Inspectors must also comply with the appropriate facility-specific procedures in order to maintain its phytosanitary integrity. These procedures may include wearing disposable footwear covers and overalls. If, as is recommended, propagation is actively taking place while the audit is performed, the cutting area should be observed from a distance no closer than is necessary to verify that aseptic techniques are used. Great care must be taken to ensure that CFIA inspectors themselves will not be the source of contamination or infection of nuclear stock propagative material, and this aspect cannot be over-emphasised.

A form specifically for reporting audits in an aseptic environment has been developed: Nuclear Stock Aseptic Facility Inspection Report (CFIA/ACIA 5292)(For internal use only). This form is checklist-based and also serves as a reminder of all aspects that should be considered during the inspection. This form is presented in Appendix 6-1.5

When conducting an audit of a multiplication facility, inspectors should be aware of the following guidelines:

  • A copy of the Application for Seed Potato Crop Inspection - Grower's Declaration (CFIA/ACIA 1317) (For internal use only) submitted for the crops being inspected should accompany the inspector. During the inspection, it should be verified that the material being multiplied matches the information shown on the application form. Any discrepancies should be clearly highlighted and rectified (note: any modifications to the form must be initialled by the original applicant).
  • The inspector should confirm that the facility owner/operator is in possession of the following reference documents and that they are up to date:
  • The inspector should review the following documentation maintained by the grower:
    • A procedures manual;
    • Copies of test results and sample submission dates;
    • Propagation schedules;
    • Distribution records;
    • The information system described in directive D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes (Section 2.1.6).
  • Disease testing for each variety/clone under active multiplication will be 1% or a minimum of 5 plantlets to a maximum of 50 plantlets per clone.
  • The inspector should confirm that the facility uses recognised aseptic propagation procedures, noting carefully such points as:
    • All working surfaces must be appropriately disinfected before use
    • Cutting equipment must be properly disinfected between each plant or group of plants
    • Cuttings should not come into contact with potentially contaminated surfaces
    • The facility should demonstrate how it verifies the effectiveness of its laminar flow benches and the frequency of filter changes (i.e., test certificates should be available).
  • The growth room must be inspected. A reasonable number of growth jars should be inspected for general contamination and to assess apparent health of the propagative material. Care must be taken in order to avoid opening the jars or breaking their seals during this part of the inspection.
  • The inspector should ensure that systems that maintain varietal integrity be in operation at the facility. These should be adequately demonstrated/explained by the producer during the audit/inspection.
  • The inspector should ensure that procedures for disposal of containers, if they show signs of bacterial or fungal contamination, exist. These procedures should be adequately demonstrated/explained by the producer during the audit/inspection.
  • The inspector should confirm that clear labelling of each variety/clone is evident, and that separation exists between the material being produced for certification as nuclear stock seed potatoes and any other material.
  • If the facility does not comply with the Seeds Regulations Part II or does not meet the requirements described in policy directive D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes, the grower must be notified immediately. A form has been developed for reporting non-compliance: Notification of Non-compliance of Nuclear Stock Class Seed Potato Production Facility and Requirement for Corrective Action (CFIA/ACIA 5294)(For internal use only). A sample of this form can be found in Appendix 6-1.7. This form should be completed and signed at the audit site, and a copy provided to the producer on the inspector's return to the office. A reasonable period of time should be given for the deficiency to be corrected, depending on the seriousness of the deficiency. A follow up audit must be carried out to ensure compliance, and the appropriate section of the form completed to confirm this. If, during the follow up audit, it is determined that requested corrective actions have not been implemented, a written notice should be sent to the applicant, and a copy provided to the Area Specialist for potatoes.
  • After all required audits have been completed, and the varieties present on the Application for Seed Potato Crop Inspection - Grower's Declaration (CFIA/ACIA 1317) (For internal use only) have passed inspection, then the crop has met all the requirements for its class. A Growing Crop Certificate - Seed Potato (CFIA/ACIA 1318)(For internal use only) shall be issued no later than 40 days after the final audit of the facility has been completed.

6.7.4 Multiplication of Nuclear Stock in a Protected Environment

The Seeds Regulations Part II stipulates that an Application for Seed Potato Crop Inspection - Grower's Declaration (CFIA/ACIA 1317) (For internal use only)for nuclear stock produced in a protected environment should be submitted within 30 days after planting. However, there is also an expectation that the grower should contact the local CFIA office prior to planting, to discuss production plans. This will facilitate a pre-planting inspection of the protected environment structure to be carried out, should the inspector consider this to be necessary. If a pre-planting is carried out, it should be recorded in Part A on the form Nuclear Stock Protected Environment Inspection Report (CFIA/ACIA 5293)(For internal use only) (see Appendix 6-1.6).

Floor plans indicating the location of each variety planted within a protected environment must be submitted with the application. These will be used during audits of the facility.

Material produced in a protected environment requires at least one inspection during the growing season (in addition to any pre-planting inspections carried out).

Nuclear stock crops grown in protected environments are planted with pathogen-free laboratory tested material. Therefore, the inspection should focus on procedures, varietal integrity and the physical structure of the protected environment (i.e., to ensure that the required elements to keep the crop free of pathogens, mainly relating to excluding insect vectors, are intact). Nevertheless, the inspector must also be vigilant for possible disease symptoms.

The inspection should take place when the crop is budding or flowering as it is the optimal time for observation of varietal characteristics. This may prove difficult since most facilities contain numerous cultivars which express recognisable characteristics at different times. In addition, many varieties do not show their typical field characteristics under protected environment conditions. Observation of taxonomic traits such as inflorescence (flowers) is the key to the recognition of varieties under these conditions. Where doubt is placed on the integrity of the cultivar, arrangements should be made to perform additional inspections. In addition, if absolutely necessary (e.g., where unresolvable dispute arises), leaf samples can also be taken for molecular testing to confirm variety identity.

A form for inspecting protected environments during the growing season has been developed: Nuclear Stock Protected Environment Inspection Report(CFIA/ACIA 5293)(For internal use only). This form is checklist-based and also serves as a reminder of all aspects that should be considered during the inspection. This form is presented in Appendix 6-1.6.

Since there are such stringent phytosanitary requirements for nuclear stock, and since the rest of the certification system ultimately depends on the quality of nuclear stock entering the flush-through system, inspectors should ensure that their visit will not compromise the phytosanitary integrity of the crop. Inspectors must remember that their own presence confers a phytosanitary risk to the protected environment facility. Therefore, the guidelines below should be adhered to, in order to minimise this risk to the growing crop.

Inspection of protected environment facilities must be the first inspection of the day or following an aseptic facility audit (note there is, therefore, also a need to schedule inspections of different facilities on different days). Under no circumstances whatsoever should a protected environment is inspected after inspecting any lower classes of seed potatoes, or visiting any potato processing or storage facilities. Vehicles should be washed before visiting a protected environment and any footwear must have been cleaned and disinfected (a spray bottle should be taken to the facility so that footwear can be disinfected immediately prior to entering the premises); clothing must also be clean. Great care must be taken to ensure that CFIA inspectors themselves will not be the source of contamination or infection of propagative nuclear stock, and this aspect cannot be over-emphasised.

In addition to the above, inspectors' own health and safety is a primary concern. Before the protected environment is entered, inspectors must ensure that it is safe to do so and that if any fumigants or chemicals have been deployed, the dispersal period recommended by the manufacturer of the chemical agent has completely elapsed. Protected environments should also be avoided under extreme hot temperatures.

Prior to embarking on the inspection visit, the inspector must ensure that adequate equipment and resources have been assembled. It is essential that inspectors of protected environment facilities being used for the production of nuclear stock have the following resources with them:

Prior to commencing the physical inspection, all documents relating to the production facility and required of the owner by the Seeds Regulations Part II and D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes should be reviewed. These documents include:

  • If planted with material produced by an aseptic environment within the same farm unit, evidence that the crop was grown from material produced in an aseptic environment (or from first generation mini-tubers produced on the same farm unit);
  • If planted with material produced by a separate farm unit, copies of all nuclear stock certificates, nuclear stock tags, or certificates of authorisation, as presented with the original application for seed potato crop inspection, must also be retained on the grower's premises;
  • Each crop under production must have valid disease testing results at the time of planting in a protected environment, unless planting first generation mini-tubers. If first generation mini-tubers and/or stem cuttings are used to produce a second generation, a CFIA inspector shall not certify the second generation unless material from the first generation or the second generation have been tested by a CFIA-approved laboratory and found to be free from BRR, PSTV, PVA, PVM, PVY, PLRV, PVS and PVX. All disease tests are valid for a period of 12 months commencing on the date that the sample was received for testing at the CFIA-approved laboratory. In this instance, valid disease test results would be required at the time of planting of the crop used to produce the second generation or at the time of issuance of the growing crop certificate. When additional pathogen testing is required on a crop producing mini-tubers, samples for virus and viroid testing should be collected at budding/flowering time (approximately 40 -70 days after planting) and for C. m. sepedonicus as per directive D-97-12 (Seed potato certification program – Bacterial ring rot testing program for field grown seed potatoes). Testing must be done on a representative sample consisting of 1% of the plants/tubers with a minimum of 5 and a maximum of 50 plants/tubers sampled per crop/lot. All plants and when applicable, at least one tuber per plant, must be tested if the total number of plants of a variety or clone is less than 5. All samples taken for required pathogen testing must be collected by or under the supervision of a CFIA inspector;
  • The producer must adopt an information system that includes effective sanitation practices and effective insect and disease monitoring and prevention procedures (i.e. use of sticky traps for aphid monitoring, adoption of integrated pest management practices, records of any pests or diseases observed and corrective actions taken, etc.).

When physically inspecting protected facilities, the aspects listed in the following bullet points should all be considered. The growing crop should be inspected first, followed by a thorough examination of the inside and of the outside of the structure. Part B of Nuclear Stock Protected Environment Inspection Report (CFIA/ACIA 5293)(For internal use only) also serves as a reminder for the points that should be inspected.

  • The facility must utilise a double-door entrance in which the doors form an aphid-proof closure.
  • A footwear disinfectant bath must be present at the entrance to the facility. The disinfectant utilized must be registered with the PMRA or otherwise recognized as an effective disinfectant against C. m. sepedonicus and be changed at regular intervals as recommended on the manufacturer's label.
  • The crop (i.e., each individual variety grown) should be thoroughly inspected for both regulated and non-regulated disease symptoms and the presence of insect vectors (aphids). Aphids prefer and tend to congregate on soft new growth and inflorescence stems. Therefore, a number of flowers, and young leaves towards the top of the canopy, should be scrutinised to look for aphids. Yellow sticky traps must be present, and these should also be inspected to gauge insect activity in the environment. It is recommended that a yellow sticky trap also be present within the double door entrance, between the inner and outer doors. This will help monitor possible aphid incursions at this point, and can also intercept aphids before they enter the growth area (for this reason, they should be recommended strongly to the grower). Note carefully the requirements for subsequent disease testing in policy directive D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes (Sections 2.4.14 and 2.4.15) should aphids be found within the protected environment.
  • If there is any doubt over possible disease symptoms being expressed by a variety being grown to be certified as nuclear stock class seed potatoes, the inspector should collect leaf samples and submit them for testing to the CFIA Charlottetown Laboratory, PEI.
  • The inspection should confirm that no field or non-nuclear stock class seed potatoes, nor any other Solanaceous material, are present in the facility. No plants other than those potato plants being produced for certification as Nuclear Stock and listed on the Application for Seed Potato Crop Inspection - Grower's Declaration (CFIA/ACIA 1317) (For internal use only) may be present in the protected environment while Nuclear Stock is being grown. If there is a connection between protected environments, a secure pest-resistant physical separation must be present between Nuclear Stock seed potatoes and all other plants being grown in a different protected environment on the same farm unit.
  • Nuclear Stock class propagative material must be planted in soil-free medium which has not been previously used to produce any crop.
  • The inspector should attempt to confirm that there is no potato debris along outer walls, floor or inside pots.
  • If ground beds are used, the underlying soil must be separated by a new or a clean and disinfected physical barrier from the growing medium (e.g., separated by landscape cloth).
  • If containers are used they must be new or must have been thoroughly cleaned and disinfected before each use.
  • All varieties must be physically separated from one another by means of physical barriers to maintain varietal integrity and purity. This could be accommodated by, for example, using dividers in beds, or the growing of individual varieties in individual containers.
  • During the inspection, the floor-plan should be compared and its accuracy verified in relation to all varieties present.
  • The facility must be aphid-proof at all possible entry points (i.e., mesh screening used must have a screen hole size smaller than 0.007 square centimetre (0.001 square inch), must be present on all air intakes, exhausts, vents and so on, including louvered vents). The structure should also be checked very carefully to ensure that there are no holes or tears present which could allow entrance of aphids/insect vectors.
  • Inspectors are advised that the screening around the ventilation exhaust fans should be examined closely (looking through the screen from the outside). Due to the air-flow, this is where the majority of insects will accumulate. If aphids are present in the greenhouse, there is a good chance that they will be seen on the inside of the screen.

If the facility does not comply with the Seeds Regulations Part II or does not comply with the requirements of policy directive D-97-08: Production, Maintenance, Multiplication and Certification of Nuclear Stock Class Seed Potatoes and corrective actions are required, they should be immediately communicated to the grower using the report of non-compliance form Notification of Non-compliance of Nuclear Stock Class Seed Potato Production Facility and Requirement for Corrective Action (CFIA/ACIA 5294)(For internal use only). A reasonable period of time should be given for the deficiency to be corrected, depending on the seriousness of the deficiency. A follow-up inspection must be carried out to ensure compliance, and the appropriate section of the form completed to confirm this. If during the follow up inspection it is determined that requested corrective actions have not been implemented, a written notice should be sent to the applicant, and a copy provided to the Area Specialist for potatoes. The notice should specify that the crops will be granted a lower class, i.e., Pre-Elite, if all requirements are not met within a specified period, provided the regulatory requirements for the class assigned have been met.

After all required inspections of a protected environment nuclear stock facility have been completed, and if the crops have met all the requirements for their respective class then the Growing Crop Certificate – Seed Potato (CFIA/ACIA 1318)(For internal use only) shall be issued no later than 40 days after the final inspection has been completed.

Appendix 6.1 Forms used in nuclear stock inspection

6-1.1 Application for Seed Potato Crop Inspection - Grower's Declaration (CFIA/ACIA 1317) (For internal use only)

Completed by grower for inclusion in seed potato certification program. Special attention is given to signatures of grower or representative, varieties and tuber unit portion, hectares and source of seed being indicated on this form. Sample of Form CFIA/ACIA 1317

6-1.2 Nuclear Stock Certificate- Seed Potato Program (CFIA/ACIA 4351)(For internal use only)

Used to document the movement of Nuclear Stock class seed potatoes of a registered variety from one farm unit to another within Canada. Also used for the movement of all varieties to another country. Sample of Form CFIA/ACIA 4351

6-1.3 Certificate of Authorization - Seed Potato (CFIA/ACIA 4378)(For internal use only)

Permits the movement of seed potatoes of a non-registered variety for which a crop certificate has been issued, between farm units in Canada. Sample of Form CFIA/ACIA 4378

6-1.4 Growing Crop Certificate - Seed Potato (CFIA/ACIA 1318)(For internal use only)

Specifies the variety, class, area, and the certification number of every lot certified as seed potato on the farm unit. Sample of Form CFIA/ACIA 1318

6-1.5 Nuclear Stock Aseptic Facility Inspection Report (CFIA/ACIA 5292)(For internal use only)

This form is to be used for recording inspections/audits carried out at aseptic facilities initiating or multiplying nuclear stock. Sample of Form CFIA/ACIA 5292

6.1.6 Nuclear Stock Protected Environment Inspection Report (CFIA/ACIA 5293)(For internal use only)

This form is to be used for recording pre-planting (part A) and growing crop (part B) inspections/audits carried out in protected environment facilities. Sample of Form CFIA/ACIA 5293

6.1.7 Notification of Non-compliance of Nuclear Stock Class Seed Potato Production Facility and Requirement for Corrective Action (CFIA/ACIA 5294)(For internal use only)

This form is to be used for reporting non-compliance and corrective action in both aseptic and protected environment facilities. Sample of Form CFIA/ACIA 5294

6.1.8 Application Form for Issuance of Nuclear Stock Tags and Certificates (CFIA/ACIA 5295) (For internal use only)

This Application Form for Issuance of Nuclear Stock Tags and Certificates (CFIA/ACIA 5295) is intended to create uniform service delivery across different regions.

Appendix 6-1.1 Application for Seed Potato Crop Inspection- Grower's Declaration (CFIA/ACIA 1317) – Example

This image is an example of an Application for Seed Potato Crop Inspection - Grower's Declaration (CFIA/ACIA 1317) (For internal use only).
Application for Seed Potato Crop Inspection. Description follows.
Description for - Form CFIA/ACIA 1317

This is an image of an example of the Application for Seed Potato Crop Inspection – Grower's Declaration CFIA 1317 that has been filled out by a grower applying for their potato crops' inclusion in the seed potato certification program. At the top of the form there is space for the CFIA file number, CFIA office name to which the form is to be sent, then there is space for the name, phone number and address of the grower, grower number, farm location by lot, concession, township and county or range. There is a check box to indicate whether the seed was treated and a box to indicate what treatment was applied. Below this, there is an instruction box instructing the grower to use one line for each potato crop planted on a field by field basis, and to indicate which are entered for certification with an X and also to attach one tag or certificate for any purchased seed. Below the instruction box, there is space to indicate the field number, the X to indicate whether the field is entered for certification, the variety, number of hectares mass planted or planted by tuber unit, the class and certification number of the seed planted, the quantity planted, the date of planting, the field or crop history in the past two years and the location of the field. Below this, the form indicates the application fee of $50, and then a space to calculate the cost of applying for the total hectares entered for certification at 20 dollars per hectare, plus GST, HST and PST as applicable to generate the total fees payable to the CFIA. There is also a check box to indicate whether CFIA received payment. Below this, there is a declaration by the applicant that they are applying for inspection of the above crops marked with an X that: all of the crops were planted from Foundation Class or better; that at least two lots from the farm unit were subjected to laboratory tests and not found positive for the presence of Clavibacter michiganensis subsp. Sepedonicus; that all required inspection fees have been attached; that the applicant will grade any portion of any potato crop as seed to the required tuber standards; and whether or not the applicant consents to the release of the results of inspection for marketing purposes. At the bottom of the form, there is space for the applicant to add their signature and date as well as a note indicating that the signatures of all member of a partnership are required.

Appendix 6-1.2 Nuclear Stock Certificate- Seed Potato Program (CFIA/ACIA 4351) (For internal use only) – Example

This image is an example of a Nuclear Stock Certificate- Seed Potato Program form (CFIA/ACIA 4351).
Nuclear Stock Certificate. Description follows.
Description for - Form CFIA/ACIA 4351

This is an image of a Nuclear Stock Certificate (CFIA/ACIA 4351) that must be filled in by a CFIA inspector. This form is used to document the movement of Nuclear Stock class seed potatoes of a registered variety from one farm unit to another within Canada. It is also used for the movement of all varieties to another country. The form contains a section to identify the type of material: mini-tubers; micro-tubers, or stem cuttings; micro-cuttings and their volume and quantity. Below, are boxes for the Grower name and address and consignee name and address. There are also boxes to indicate the number and description of packages and any distinguishing marks. Then, there are spaces for information on the name of the variety, the lot identification number, the quantity and the date where the samples were last submitted for disease testing. At the bottom, there is a box for the inspector’s name, number and signature and the date it was signed.

Appendix 6-1.3 Certificate of Authorisation- Seed Potato (CFIA/ACIA 4378) (For internal use only)– Example

This image is an example of a Certification of Authorization form (CFIA/ACIA 4378).
Certification of Authorization form. Description follows.
Description for - Form CFIA/ACIA 4378

This image is an example of a Certification of Authorization form. This form is issued by an inspector when a seed potato grower is selling within Canada a variety of potatoes that does not qualify for seed potato tags or a record of bulk movement for seed potatoes because the variety is not registered in Canada. This form provides checkboxes to outline whether the seed potatoes are being shipped from the farm unit to another for the purpose of multiplication for the purpose of registration or for experimental purposes. Below this section there are spaces provided for the grower's name and the date it was filled out. The next section of the form provides the grower information on the left such as: the name and address of the grower, a description of the packages, the variety, and the class. The information provided on the right of this includes the consignee's name and address, the quantity, and the certification number. At the bottom of the form there are spaces for the director's signature and the date it was signed.

Appendix 6-1.4 Growing Crop Certificate- Seed Potato (CFIA/ACIA 1318) (For internal use only)– Example

This image is an example of a Growing Crop Certificate (CFIA/ACIA 1318).
Growing Crop Certificate- Seed Potato. Description follows.
Description for - Form CFIA/ACIA 1318

This image is an example of Growing Crop Certificate; it declares that the growing crop indicated by the certificate number meets the requirements for the class indicated.

The form requires information such as: the variety, the number of hectares, the certificate number, the class, the program officer's signature, and the date it was signed.

Appendix 6-1.5 Nuclear Stock Aseptic Facility Inspection Report (CFIA/ACIA5292) (For internal use only)– Example

This image is an example of a Nuclear Stock Aseptic Facility Inspection Report (CFIA/ACIA 5292).
Nuclear Stock Aseptic Facility Inspection Report. Description follows.
Description for - Form CFIA/ACIA5292

This is an image of an example of a Nuclear Stock Aseptic Facility Inspection Report CFIA/ACIA 5292 (For internal use only) that has been filled out by a CFIA inspector during an inspection of an aseptic facility producing nuclear stock. The form has space for the grower's name, phone and fax number, address, grower number, CFIA inspector name and date of application. Below this, there is space to indicate whether the criteria of the nuclear stock program have been met by indicating with an X in the yes or no column as appropriate and adding any supplementary comments. At the bottom of the form, there is space for the grower's and inspector's signature and date.

Appendix 6-1.6 Nuclear Stock Protected Environment Inspection Report (CFIA/ACIA5293) (For internal use only)– Example

This image is an example of the first part of a Nuclear Stock Protected Environment Inspection Report (CFIA/ACIA 5293)
Nuclear Stock Protected Environment Inspection Report. Description follows.
Description for - Form CFIA/ACIA5293

This is an image of an example of a Nuclear Stock Protected Environment Inspection Report CFIA/ACIA 5293 that has been filled out by a CFIA inspector to record pre-planting and growing crop inspection and audits carried out in protected environment facilities producing Nuclear Stock class seed potatoes. There is space for the grower's name, phone number, fax number, address, grower number, CFIA inspector name, date of application, an alternative contact name, whether the crop is the first, second or third and the number of units at the protected environment facility producing nuclear stock. Below this, there are criteria for the CFIA inspector to evaluate during a pre-planting inspection of the protected environment facility by indicating with an X in either the yes or no box as appropriate and adding any supplementary comments. At the bottom of the form there is space for the grower's and inspector's signatures along with the date.

This image is an example of the second part of a Nuclear Stock Protected Environment Inspection Report (CFIA/ACIA 5293).
The second part of a Nuclear Stock Protected Environment Inspection Report. Description follows.
Description for - Form CFIA/ACIA 5293

This is an image of an example of a Nuclear Stock Protected Environment Inspection Report CFIA 5293 that has been filled out by a CFIA inspector to record pre-planting and growing crop inspection and audits carried out in protected environment facilities producing Nuclear Stock class seed potatoes. There is space for the grower's name, phone number, fax number, address, grower number, CFIA inspector name, date of application, an alternative contact name, whether the crop is the first, second or third and the number of units at the protected environment facility producing nuclear stock. Below this, there are criteria for the CFIA inspector to evaluate during a pre-planting inspection of the protected environment facility by indicating with an X in either the yes or no box as appropriate and adding any supplementary comments. At the bottom of the form there is space for the grower's and inspector's signatures along with the date.

Appendix 6-1.7 Notification of Non-compliance of Nuclear Stock Class Seed Potato Production Facility and Requirement for Corrective Action
(CFIA/ACIA5294) (For internal use only) – Example

This image is an example of a Notification of Non-compliance of Nuclear Stock Class Seed Potato Production Facility and Requirement for Corrective Action form (CFIA/ACIA 5294).
Application Form for Issuance of for Nuclear Stock Tags and Certificates. Description follows.
Description for - Form CFIA/ACIA5294

Notification of Non-compliance of Nuclear Stock Class Seed Potato Production Facility and Requirement for Corrective Action is used for reporting non-compliance and corrective action in both aseptic and protected environment facilities. This form has four main sections: the first section provides information regarding the grower and the inspection such as the grower's title and name, telephone number, address, grower number, name of the alternative contact, name of the inspector, and date of application. Also, there are two boxes to indicate whether it is in-vitro or protected environment production. The second section is for only protected environments and used to indicate the crop, i.e. 1st, 2nd, or 3rd, the number of units producing nuclear stock and the unit number the notification refers to. The third section details the description of non-compliance and the time in which the defect has to be rectified within to remain eligible for certification and when the inspector has to return to verify that the appropriate corrective action has been taken. Below, it is for the grower's signature, inspector's signature and the date it was signed. The last section is for the verification of compliance which requires indicating whether or not the corrective action has been taken and the facility now complies with the seed potato program as well as the inspector's signature and the date it was signed.

Appendix 6-1.8 Application Form for Issuance of for Nuclear Stock Tags and Certificates (CFIA/ACIA 5295) – Example

This image is an example of an Application Form for Issuance of Nuclear Stock Tags and Certificates (Application Form for Issuance of Nuclear Stock Tags and Certificates (CFIA/ACIA 5295)) (For internal use only).
Application Form for Issuance of for Nuclear Stock Tags and Certificates. Description follows.
Description for - Form CIA/ACIA 5295

This image is an example of an Application Form for Issuance of Nuclear Stock Tags and Certificates. At the top of the form it provides space for information regarding the grower or facility name, the date the issuance was requested, and the consignee's name and address. Below this, there is a note to the applicant that tags or certificates must accompany the shipment and cannot be backdated. In the main portion of the form there is a table with the column headings: variety, certification number, material type and generation, quantity to be shipped, destination, and date last submitted for testing. Below these headings are rows and spaces provided to insert the corresponding information. Below the table is text associated with the asterix beside the column heading for material type and generation that reads if mini-tubers are being shipped this application must indicate whether they are first or second generation. Below this note, there is a declaration that the above information is accurate to be best of the applicant's knowledge and that all material being shipped has been approved and certified by the CFIA, then there are spaces for the applicant's signature and the date the application was completed. At the bottom of the form there is a section designated for the CFIA office's use only, and requires the date that the nuclear production facility was last inspected and approved, and the date the tags/certificate(s) were issued and a signature of the CFIA inspector issuing the tags or certificates.

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