D-12-03: Domestic Requirements for Potentially Injurious Organisms (Other than Plants) to Prevent the Spread of Plant Pests Within Canada
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This directive contains the requirements for conducting activities on potentially injurious organisms (other than plants) regulated under the Plant Protection Act. This includes, for example, requirements for moving and transferring these organisms within Canada.
The Canadian Food Inspection Agency (CFIA) regulates the conduct of activities in respect of potentially injurious organisms for the potential risks to Canadian plant resources. Potentially injurious organisms governed by this directive include, but are not limited to, those:
- Imported into Canada under a special permit and required to be kept in containment (i.e. cannot be released into the environment)
- Included on the list of Pests Regulated by Canada published by the CFIA
Activities governed by this directive include those activities referenced in the definition of the term "activity" in the Plant Protection Act and Plant Protection Regulations, i.e., moving, growing, raising, cultivation, production, processing, handling, packaging, labelling, distribution, sale, disposition, loading, unloading, use, treatment, preservation, safeguarding and storage (hereinafter collectively referred to as "Activities").
N.B.: The policy relating to the importation of potentially injurious organisms is not included in the scope of this directive. Information on the import requirements for potentially injurious organisms (other than plants) regulated under the Plant Protection Act is contained in D-12-02: Import Requirements for Potentially Injurious Organisms (Other than Plants) to Prevent the Importation of Plant Pests in Canada. Guidance on applying for a plant protection permit to import is available from the CFIA's Plant Protection Policy Directive D-97-04: Application, procedures, issuance and use of a Permit to Import under the Plant Protection Act.
Table of Contents
- Amendment Record
- Distribution List
- Definitions, Abbreviations and Acronyms
- 1. General Requirements
- 2. Specific Requirements
- 3. Written Authorization
- 3.1 Purpose
- 3.2 Containment Standards for Facilities Handling Plant Pests
- 3.3 Temporary Removal of Regulated Potentially Injurious Organisms from Authorized Facilities
- 3.4 Application for a Written Authorization
- 3.5 Issuance of Written Authorization
- 3.6 Validity of Written Authorization
- 4. Movement of Regulated Potentially Injurious Organisms
- 5. Inspection Requirements
- 6. Non-Compliance
- Appendix I: Summary Table of Requirements
- Appendix II: Application template for a Written Authorization to conduct Activities on Potentially Injurious Organisms regulated under the Plant Protection Act
This directive will be updated as required. For further information or clarification, please contact the CFIA.
Chief Plant Health Officer
Amendments of this directive will be dated and distributed as outlined in the distribution below.
- Directive mail list
- Provincial governments, other Federal departments, non-governmental organizations (as determined by Author)
- Industry Organizations (as determined by Author)
Certain potentially injurious organisms (e.g. insects, mites, earthworms, snails, slugs, bacteria, fungi and viruses) are regulated under the Plant Protection Act because, for example, they are or may be plant pests or may be contaminated with plant pests. Plant pests can cause serious damage to Canada's natural environment as well as to its agriculture and forestry sectors. Consequently, Activities undertaken in Canada in respect of these potentially injurious organisms are subject to requirements to prevent the introduction and spread of plant pests into the environment.
Potentially injurious organisms which would otherwise be inadmissible because of the pest risk may be imported into Canada under special permit and for specific purposes, such as for research, education or exhibition purposes. To prevent the escape, introduction and spread of these organisms into the environment, conditions to prevent their further movement and transfer in Canada are specified on Permits to Import.
There has been growing interest among stakeholders for greater flexibility in the scope of Activities that may be conducted on regulated potentially injurious organisms, such as their movement and transfer within Canada in the pursuit of those same purposes. This directive provides a policy framework and formal process for allowing Activities to be conducted on certain potentially injurious organisms obtained within Canada, either from the environment or from another person.
It is recognized that the pest risks associated with such Activities may be managed and mitigated to the same degree as with the import of regulated potentially injurious organisms, for which the requirements are set out in the plant protection policy directive D-12-02: Import Requirements for Potentially Injurious Organisms (Other than Plants) to Prevent the Importation of Plant Pests in Canada. The present directive sets out the domestic plant health requirements for conducting Activities in respect of these organisms, and includes an application and authorization process. The CFIA may authorize proposed Activities under specific circumstances and require that the conduct of the Activities be subject to pest risk management conditions.
This directive is intended for use by CFIA staff and by persons wanting to conduct Activities within Canada on potentially injurious organisms regulated under the Plant Protection Act.
- CFIA Plant Protection Policy Directives including:
- List of Pests Regulated by Canada published by the CFIA
- CFIA's Containment Standards for Facilities Handling Plant Pests
Definitions, Abbreviations and Acronyms
For the purposes of this directive:
- "Transfer" refers to the passing of potentially injurious organisms from one person to another, and includes transfer of the responsibility for complying with plant health requirements.
- "Written Authorization" refers to a letter issued by the CFIA under the authority of the Plant Protection Regulations which allows a person to undertake activities, with respect to potentially injurious organisms, which are otherwise prohibited or restricted under the Plant Protection Act and Plant Protection Regulations. This letter also sets out the conditions under which the activities may be conducted.
- "Authorized facility" refers to a facility that meets, as determined by the CFIA, appropriate physical and operational requirements described in the Containment Standards for Facilities Handling Plant Pests or in its Addendum for Containment Zones where Low-Risk Exotic Invertebrates are Displayed, and that has a valid compliance or certification identification number assigned by the CFIA.
Definitions for other terms used in the present document can be found in the Plant Health Glossary of Terms
1. General Requirements
1.1. Legislative Authority
Plant Protection Act, S.C. 1990, c. 22
Plant Protection Regulations, SOR/95-212
Canadian Food Inspection Agency Fees Notice, Canada Gazette, Part I (as amended from time to time)
Agriculture and Agri-Food Administrative Monetary Penalties Act, S.C. 1995, c. 40
Agriculture and Agri-Food Administrative Monetary Penalties Regulations, SOR/2000-187
The CFIA is charging fees in accordance with the Canadian Food Inspection Agency Fees Notice. Anyone requiring information regarding fees may contact any local CFIA office or visit the Fees Notice section of our website.
1.3. Regulated Potentially Injurious Organisms
- Organisms on the list of Pests Regulated by Canada.
- Potentially injurious organisms that were imported into Canada with the requirement of a Permit to Import issued pursuant to Section 43 of the Plant Protection Regulations, including those that subsequent to their import were transferred to another person.
Other potentially injurious organisms may be regulated under this directive, depending, among other factors, on their origin, distribution and potential for presenting a pest risk to Canada (e.g., where their presence predates CFIA import requirements). Furthermore, some plant pests regulated under this directive may also be governed by other Plant Protection Policy Directives and be subject to specific prohibitions or restrictions. This must be verified with your local CFIA office.
1.4. Potentially Injurious Organisms Exempt from this Policy
- Regulated potentially injurious organisms located in or destined for an area in Canada in which the organism is officially recognized by the CFIA to be present, or where the CFIA has otherwise authorized the release of these organisms. This is conditional however, upon requirements that may be set out in a Permit to Import. Also, movement requirements within such an area or to prevent movement from this area to other areas may nevertheless apply, as may be set out in another Plant Protection Policy Directives. This must be verified with the local CFIA office.
- Regulated potentially injurious organisms in respect of which Activities are authorized and conducted in accordance with the conditions and with any other information set out in a Permit to Import.
- Potentially injurious organisms which are plants. Requirements may nevertheless apply. This must be verified with your local CFIA office, and consult the CFIA on Invasive Plants.
1.5 Regulated Areas
All parts of Canada, subject to the area-based exemptions set out in section 1.4 of this directive. This must be verified with your local CFIA office.
2. Specific Requirements
A written authorization to conduct prohibited and restricted activities (Written Authorization) from the CFIA is required before a person may receive and conduct Activities in respect of regulated potentially injurious organisms. Section 3 of this directive provides more detailed information on requirements including on applying for a Written Authorization.
Furthermore, the movement of regulated potentially injurious organisms must be authorized in writing by the CFIA, either under a movement certificate or a Written Authorization depending on the circumstances. This includes the movement of organisms to or from facilities working with regulated potentially injurious organisms. Section 4 of this directive provides further information on movement requirements and conditions.
The requirements are summarized in Appendix I.
3. Written Authorization
Activities in respect of the regulated potentially injurious organisms may only be undertaken for one of the following purposes: scientific research, exhibition/display, education and industrial/processing.
To qualify for "scientific research", the regulated potentially injurious organisms must be:
- destined for a research laboratory owned and operated by a chartered academic institution, a federal, provincial, municipal or aboriginal self-government, or a research and development section of a corporation;
- contained within a research laboratory / facility; and
- safeguarded, treated, disposed of (e.g. incinerated, autoclaved) upon completion of the research project, unless as otherwise permitted in accordance with the Written Authorization (e.g., to maintain the material for further propagation or as part of a collection or a reference bank or to transfer the organisms to another facility).
An outline / description of the proposed research project must be provided to the CFIA.
To qualify for "educational purposes", the regulated potentially injurious organisms must be destined for a federal or provincial owned and operated school, a chartered academic institution or institutions such as museums or zoos, and must be used on the institution's property for educational purposes.
To qualify for "exhibition purposes", the regulated potentially injurious organisms must be destined for an exhibition / show in Canada.
To qualify for "processing" or "industrial purposes", the regulated potentially injurious organisms must be destined for a manufacturing, processing or treatment plant which will alter or modify the material in such a manner that will render the organisms non-viable.
Note: A Written Authorization will not be issued in relation to regulated potentially injurious organisms that are destined for a facility which is also a dwelling-place, or that are otherwise contained in such a place.
3.2. Containment Standards for Facilities Handling Plant Pests
To conduct Activities in respect of regulated potentially injurious organisms, compliance is required with the CFIA's Containment Standards for Facilities Handling Plant Pests (CSFHPP), or as applicable with its Addendum for Containment Zones where Low-Risk Exotic Invertebrates are Displayed.
Facilities must comply with the appropriate plant pest containment level for the organisms in question as determined by the CFIA. Containment standards and levels are described in the CSFHPP. Subject to circumstances described in section 3.3 of this directive, regulated potentially injurious organisms must be contained and handled in accordance with the facility compliance verification or certification obtained from the CFIA.
More information regarding the CSFHPP is available on Facilities Handling Plant Pests, or by contacting your local CFIA office or the Office of Biohazard Containment and Safety (tel. 613-773-6520; firstname.lastname@example.org).
3.3. Temporary Removal of Regulated Potentially Injurious Organisms from Authorized Facilities
The CFIA may provide a Written Authorization for the conduct of Activities in respect of regulated potentially injurious organisms on a temporary basis outside of an authorized facility. The Activities must be for one of the intended use set out in section 3.1 of this directive. Details such as location, duration, contact person and safeguards to prevent escape and spread of the organisms may be specified in the Written Authorization.
The responsibility for the regulated potentially injurious organisms, including for complying with conditions, remain with the authorized facility during the temporary removal period. To that effect, Activities cannot be conducted outside of an authorized facility if the proposal calls for the transfer of the organisms from one person to another. In these cases, the requirements presented in section 3.2 of this directive apply.
3.4. Application for a Written Authorization
An application for a Written Authorization shall be in writing, signed and dated by the person seeking to receive and conduct prohibited and restricted activities in respect of regulated potentially injurious organisms (applicant).
An applicant for a Written Authorization must be one of the following:
- a Canadian citizen or permanent resident;
- a person authorized under the laws of Canada to reside in Canada for a period of six months or more and who will have possession, care or control of the regulated potentially injurious organisms; or
- in the case of a corporation with a place of business in Canada, the applicant must be an agent or officer of the corporation who resides in Canada.
In the case of colleges and universities, only a faculty member or department head can apply for a Written Authorization on behalf of the institution. This does not include emeritus personnel.
The application shall contain the following information:
- the name, complete address, telephone and fax numbers and e-mail address of the applicant. In the case of an institution (e.g. university, college, government department or agency, or company), the application must state the legal name of the institution;
- the full scientific name (genus, species, subtype, pathovar or special form as applicable) and quantity of the organism;
- the country or area of origin of the organism, and, if known at the time of application, information on the source in Canada including as applicable on the facility that will supply the organism (name, complete address, telephone and fax numbers and e-mail address of the facility);
- details on the Activities planned in respect of the organisms, including as applicable details on any movement and transfer;
- the intended use for the Activities (i.e. scientific research, educational, exhibition, processing, industrial). When applying for scientific research purposes, the applicant must provide the CFIA with an outline/description of the proposed research project;
- the facility and location where the organism will be confined and handled; and,
- the applicant's facility compliance number or certification identification number under the CFIA's CSFHPP (if available at the time of application).
An application template for a Written Authorization is provided in Appendix II of this Directive. Please send applications to National Manager, Invasive Alien Species and Domestic Plant Health Programs (IASDP) section in the Plant Biosecurity and Forestry Division by e-mail: IAS.EEE@inspection.gc.ca, or fax: (613-773-7252).
The CFIA may communicate with the applicant and, in the case of a proposed transfer, with the supplier, to seek clarifications or to request additional information as needed to assist in its assessment of applications.
3.4.1. Temporary Removal from Authorized Facilities
For applications to temporarily conduct outside of an authorized facility Activities in respect of regulated potentially injurious organisms, the following information must also be provided:
- the intended use related to the temporary removal, including planned Activities;
- the location(s) where the organisms will be temporarily housed, with duration for each location; and
- the physical and operational measures that will be put in place to prevent the spread of the organisms, including as applicable details on the:
- use of display cases (e.g., terrarium), including whether they will be screened, sealed or kept closed;
- means of waste treatment/disposal, including procedures for the safe transport of waste to a treatment/disposal area;
- room(s) where the organisms will be housed, including information on windows, doors and service penetrations into these locations;
- personnel that will be the contact person(s) at the location(s) in question, including their knowledge and understanding of invertebrate-associated hazards and the precautions necessary to prevent the release (for example based on education, training etc.); and
- any other practices and measures that will be employed to prevent the escape of the organisms.
In reference to section 3.3 of this directive, applications proposing the temporary removal of regulated potentially injurious organisms from an authorized facility must originate from this facility.
3.5. Issuance of Written Authorization
The determination by the CFIA of whether or not to issue a Written Authorization will be based on an assessment of the information provided in the application, including of any follow-up information obtained from the applicant and supplier as applicable. The CFIA will also consider the applicant's ability and willingness to comply with conditions to prevent the escape and spread of the regulated potentially injurious organisms.
As applicable, the CFIA will consider factors such as the risk of escape and establishment of the organisms during their temporary removal from an authorized facility. This will involve consideration of the proposed activities, as well as the physical and operational practices and measures proposed to safely contain the organisms during the temporary removal period.
The CFIA will determine conditions required to prevent the spread of the organisms. Before the Written Authorization is issued or becomes valid, the applicant may be required to acknowledge in writing that the person is able and willing to comply with these conditions. The authorized facility, and as applicable the temporary location(s), may also be subject to an inspection.
The issuance of a Written Authorization will be subject to compliance with any other requirements or duties that may be imposed by or under the Plant Protection Act or any regulation or order made hereunder. Other Plant Protection Policy Directives may apply, depending for example on commodities and areas of Canada involved. Please contact your local CFIA office for more information.
3.6. Validity of Written Authorization
A Written Authorization will be valid only after the applicant has signed and dated it, and has returned it to the CFIA.
Where a Written Authorization includes the authority to obtain regulated potentially injurious organisms from another facility or source, multiple shipments may occur subject to conditions and period of validity as may be specified in the Written Authorization.
The template provided in Appendix II of this Directive may be used to apply for the renewal of a Written Authorization, as applicable.
Notwithstanding a specified period of validity the Written Authorization may be revoked by the CFIA, for example in response to a failure to comply with any of the conditions set out in the authorization.
4. Movement of Regulated Potentially Injurious Organisms
A movement certificate must be obtained from the CFIA before regulated potentially injurious organisms may be moved to a facility in which Activities on these organisms have been authorized under a Written Authorization, unless movement has otherwise been permitted in writing by the CFIA (e.g., within a Written Authorization). Please contact your local CFIA office to request a movement certificate.
The number of the recipient's Written Authorization must be provided. Where regulated potentially injurious organisms are transferred between facilities, the CFIA local office must also be provided with a copy of the supplier's authorization relevant to the organisms in question (e.g., Permit to Import or Written Authorization).
A movement certificate is not required however, for the temporary removal of organisms from an authorized facility where the Written Authorization also governs the movement of the organisms. The local CFIA office will need to be notified in these circumstances before the organisms leave the authorized facility, as set out in the conditions to the Written Authorization.
Movement certificates, or as applicable Written Authorizations, will set out conditions in order to prevent the spread of the regulated potentially injurious organisms during movement, such as:
- The organisms must be shipped directly to the destination facility or temporary location(s), as the case may be, and must be accompanied by a copy of the movement certificate or Written Authorization.
- The organisms must be transported or otherwise moved in secure, sealed, leak-proof containers that will prevent accidental release. The containers must only be opened at the destination facility or temporary location(s), as the case may be.
- Labels, tags or other efficient means of identification must be affixed to all containers to identify clearly the organisms by scientific name.
- Upon the arrival of the organisms at the destination facility or temporary location(s), as the case may be, and also upon their return to the authorized facility, the CFIA local office must be notified.
Conditions are subject to a case-by-case determination and may vary depending on the particular circumstances.
5. Inspection Requirements
Pursuant to the CFIA's operational work plan, inspectors may at any reasonable time enter and inspect a facility or location to verify compliance with the Written Authorization.
Furthermore, inspections may be conducted to determine compliance with movement conditions set out in a movement certificate or Written Authorization, as the case may be.
Persons that have obtained a Written Authorization or movement certificate will be required to notify the CFIA upon the occurrence of certain events, as set out in the conditions to these documents. For example, the local CFIA office must be notified upon the arrival of regulated potentially injurious organisms at a destination facility. These notification requirements will signal to the local CFIA offices a possible need for inspection. Pursuant to the CFIA's operational work plan, inspections may be conducted at such time to determine compliance.
In a case of non-compliance, a Written Authorization may be revoked, the regulated living organism(s) may be ordered disposed or be disposed by the CFIA. The person to whom the Written Authorization was issued, including as applicable its officers, directors or agents, will be responsible for any and all costs related to detention, quarantine, treatment, or disposal, including any costs incurred by the CFIA to monitor the action taken.
Appendix I: Summary Table of Requirements
|Scenario||Type of CFIA authorization||Requirements|
|1. To receive and conduct Activities in respect of regulated potentially injurious organisms (e.g. sourced from an authorized facility or from the environment).||Written Authorization||
|2. To temporarily conduct Activities outside of an authorized facility in respect of regulated potentially injurious organisms (e.g. for a special exhibit or education initiative).||Written Authorization||
|3. To move regulated potentially injurious organisms (s. 2, 4).||Movement certificateTable Note 1||
- Table Note 1
Unless movement has otherwise been permitted in writing by the CFIA (e.g., within a Written Authorization). A movement certificate is not required for the temporary removal of organisms from an authorized facility where the Written Authorization also governs the movement of the organisms. The local CFIA office must be notified before the organisms leave the authorized facility.
Appendix II: Application template for a Written Authorization to conduct Activities on Potentially Injurious Organisms Regulated under the Plant Protection Act
Applications must be signed and dated by the person applying for a Written Authorization (Applicant). Additional pages can be attached if needed.
Please send applications to National Manager, Invasive Alien Species and Domestic Plant Health Programs section in the Plant Protection Division by e-mail IAS.EEE@inspection.gc.ca, or Fax (613-773-7252).
The CFIA may communicate with the Applicant and, in the case of a proposed transfer, with the supplier, to seek clarifications or to request additional information as needed to assist in its assessment of applications.
To conduct Activities outside an authorized facility on a temporary basis
Provide relevant permit or Written Authorization reference number(s):
To renew Written Authorization(s)
Provide relevant Written Authorization reference number(s):
2. Applicant's Information
Name of the Applicant:
3. Information on Facility (i) where the Regulated Living Organism(s) will be Received, or (ii) from where the Organism(s) will be Removed on a Temporary Basis (as the case may be)
Name of the Facility (include room(s) as applicable):
Compliance or certification number under the CFIA's Containment Standards for Facilities Handling Plant Pests #:
4. Information on the Regulated Living Organism(s)
List by type
For example, 30 insects, 2 vials, 3 Petri dishes, 500 g
A = Another facility
B = Environment
C = Applicant's facility
|Source Name, Location, and Address
Add as needed.
Further information on organism(s) or source that may assist in the review of the application:
Are any of the regulated living organism(s) products of biotechnology?
If yes, please provide details:
5. If Applicable, Information on the Person Supplying the Regulated Living Organism(s) (Supplier)
Name of the Supplier:
Provide same information for each supplier as applicable.
6. Activity Information in Respect of the Regulated Living Organism(s)
- other(s) (for example, handling, selling, distributing, using, safeguarding and storing):
Purpose of proposed Activities
- scientific research
Details on proposed Activities and purpose that may assist in the review of the application. Include details on any movement, for example means of transport and any safeguards to prevent the escape or spread of the regulated living organism(s):
7. If Applicable, Information on the Temporary Removal of the Regulated Living Organism(s) from an authorized facility
|Locations / Addresses where organisms will be confined||Dates||Contact person(s), with title and affiliation|
Details on any measures that will be put in place to prevent the escape and spread of the regulated living organism(s) (see section 3.4.1 of the directive)
I certify that I am the applicant on this application and that I comply with the requirements of the Plant Protection Act and Plant Protection Regulations and that the information provided in this Application is true, correct and complete.
All information, including personal information, on this document is collected by the Canadian Food Inspection Agency under the authority of Plant Protection Act or Plant Protection Regulations to prevent the importation, exportation or spread of plant pests or to control or eradicate plant pests in Canada. The information may be accessible or protected as required under the provisions of the Access to Information Act.
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