Pest Control Products Regulations (SOR/2006-124)

Use of Foreign Products

Requirements

Marginal note:Procedure

37 For the purpose of subsection 41(1) of the Act, the following requirements must be met before the use of a foreign product may be authorized:

• (a) the Minister determines under section 38 that the foreign product is equivalent to a registered pest control product;

• (b) the Minister issues a certificate of equivalency under subsection 39(1) with respect to the foreign product;

• (c) the Minister approves the foreign product use label under section 40; and

• (d) the person who wishes to use the foreign product applies to the Minister for an authorization in accordance with subsections 41(1) and (2).

Product Equivalency

Marginal note:Conditions

• 38 (1) Subject to subsection (4), the Minister may determine that a foreign product is equivalent to a registered pest control product if all of the following conditions are met:

  • (a) a grower or group of growers requests the Minister to make the determination;

  • (b) four not-for-profit Canadian national grower associations support the request;

  • (c) the person who makes the request provides the Minister with all of the information listed in subsection (4);

  • (d) the foreign product meets the requirements of subsection (2); and

  • (e) the registered pest control product meets the requirements of subsection (3).

• Marginal note:Eligibility — foreign products

  (2) A foreign product must meet all of the following requirements to be considered when making a determination of equivalency:

  • (a) it is not an organism;

  • (b) it is not under review in the foreign country where it is registered with respect to its health and environmental risks and is being sold in that country;

  • (c) it does not contain an active ingredient that is under special review in Canada; and

  • (d) it is manufactured by a person who is related to the registrant of the registered pest control product, within the meaning of the definition related persons in subsection 251(2) of the Income Tax Act, whether the related person is located in or outside Canada.

• Marginal note:Eligibility — registered pest control products

  (3) A registered pest control product must meet both of the following requirements to be considered when making a determination of equivalency:

  • (a) it does not have the product class designation “RESTRICTED” described in paragraph 5(c); and

  • (b) the test data referred to in paragraphs (a) and (b) of the definition exclusive rights in section 17.01 that were provided in support of its registration are no longer subject to exclusive rights within the meaning of that definition.

• Marginal note:Interpretation — test data

  (3.1) In subsection (3), test data has the same meaning as in section 17.01.

• Marginal note:Preliminary steps

  (4) Before making the determination of equivalency, the Minister must first find that the foreign product and the registered pest control product are sufficiently similar so as to justify proceeding with the determination, based on the following preliminary information:

  • (a) the name and registration number of the registered pest control product, the name and product identifier of the foreign product and the name of the country where the foreign product is registered;

  • (b) the name of the registrant of the registered pest control product and the name of the holder of the registration of the foreign product;

  • (c) the labels of both products;

  • (d) the information described in subparagraphs 26(1)(h)(ii) and (iii) with respect to both products;

  • (e) their type of formulation;

  • (f) their type of package;

  • (g) the health and environmental risks that were evaluated by the regulatory body that registered the foreign product; and

  • (h) the standard of acceptability of risk that was applied by that regulatory body.

• Marginal note:Further information

  (5) If the Minister finds that the foreign product is sufficiently similar to the registered pest control product, the Minister must so inform the registrant and request that they provide the Minister with the following information, in respect of both the registered pest control product and the foreign product:

  • (a) the composition of all formulations of the end-use products and of the technical grade active ingredients used in their manufacture, which, in the case of the registered pest control product and its active ingredient, must be the composition specified by the Minister in the conditions of registration under paragraph 8(1)(a) of the Act;

  • (b) the name of the manufacturer of the active ingredient that is used to manufacture each of the products and the address of the place where each active ingredient is manufactured;

  • (c) the name of the manufacturer of the formulation of each end-use product and the address of the place where each formulation is manufactured;

  • (d) the information described in subparagraph 26(1)(h)(iv); and

  • (e) product safety information relevant to their use in the workplace, if any.

• Marginal note:Additional information

  (6) If the information provided under subsection (5) with respect to the registered pest control product or the foreign product is insufficient to enable the Minister to make the determination, the Minister may request additional relevant information from the registrant in order to make the determination.

• Marginal note:Written consent of registrant

  (7) Instead of providing the information required by subsection (5), the registrant may provide their written consent to the Minister to use or rely on any information that they had previously provided to the Minister.

• Marginal note:Notice of no further action

  (8) If the Minister is unable to obtain the information from the registrant under subsection (5) or the consent of the registrant under subsection (7), the Minister must notify the person who made the request that no further steps will be taken by the Minister and place a copy of that notice in the Register.

• Marginal note:Resumption of request by any person

  (9) In the circumstances described in subsection (8), paragraph (2)(d) does not apply and any person may, within two years after the notice is placed in the Register, request that the Minister make the determination of equivalency and for that purpose must provide the Minister with either

  • (a) all of the following information:

    • (i) with respect to the registered pest control product, a detailed and comprehensive analysis with an accompanying description of methodology and analytical validation that permits the determination of the acceptability of procedures, results and conclusions concerning the composition of the product, including the identity and concentration of its active ingredient and formulants, and of any contaminants in the active ingredient, and

    • (ii) with respect to any foreign product, the information described in subsection (5); or

  • (b) with respect to both the registered pest control product and any foreign product, a detailed and comprehensive analysis with an accompanying description of methodology and analytical validation that permits the determination of the acceptability of procedures, results and conclusions concerning the composition of both products, including the identity and concentration of their active ingredients and formulants, and of any contaminants in the active ingredients.

• Marginal note:Additional information

  (10) If the information provided under subsection (9) is insufficient to enable the Minister to make the determination, the Minister may request additional relevant information from the person who made the request in order to make the determination.

Certificates of Equivalency

Marginal note:Issuance

• 39 (1) If the Minister determines that a foreign product is equivalent to a registered pest control product, the Minister must issue a certificate of equivalency and place it in the Register.

• Marginal note:Validity

  (2) A certificate of equivalency is valid until December 31 in the second year after the year in which it is issued and may be reissued with respect to the same two products in accordance with the requirements of section 38. A certificate of equivalency ceases to be valid in any of the following circumstances:

  • (a) the basis on which the foreign product and the registered pest control product were determined to be equivalent no longer applies;

  • (b) any of the requirements set out in subsection 38(2) or (3) are no longer met;

  • (c) the registration of the registered pest control product is cancelled or expires and the sale and use of that product is no longer authorized under the Act; or

  • (d) the foreign product is no longer registered in the country referred to in paragraph 38(2)(b).

Marginal note:Foreign product use label

• 40 (1) When the Minister issues a certificate of equivalency, she or he must also approve a foreign product use label.

• Marginal note:Brochures or leaflets

  (2) If the Minister permits the directions for use to be shown instead in a brochure or leaflet that must accompany the foreign product, the following requirements must be met:

  • (a) the label must have prominently shown on it the statement “READ ATTACHED BROCHURE (or LEAFLET) BEFORE USING.”; and

  • (b) the brochure or leaflet must contain all of the information that is otherwise required to be shown on the label.

Authorizations to Use a Foreign Product

Marginal note:Application for authorization

• 41 (1) A person who wishes to use a foreign product in respect of which a certificate of equivalency is in effect must apply to the Minister for an authorization under subsection 41(1) of the Act.

• Marginal note:Contents

  (2) The application must include all of the following information:

  • (a) the person’s name, address and signature;

  • (b) the name of the foreign product;

  • (c) the number of the applicable certificate of equivalency;

  • (d) a description of the intended use of the foreign product and the location where it will be used; and

  • (e) the quantity of the foreign product required for that intended use for one growing season.

• Marginal note:Issuance of certificate

  (3) If the Minister authorizes the use of the foreign product, she or he must issue a foreign product use certificate that sets out all of the following information:

  • (a) the identity of the certificate holder;

  • (b) the amount of the foreign product that may be imported and used under the certificate; and

  • (c) the location where the foreign product is to be used by the certificate holder.

• Marginal note:Validity

  (4) A foreign product use certificate is valid for only one importation and for the period specified in the certificate, which must not exceed one calendar year. It ceases to be valid if the applicable certificate of equivalency ceases to be valid.

• Marginal note:Not transferable

  (5) A foreign product use certificate is not transferable.

Marginal note:Importation of foreign product

• 42 (1) A person may import a foreign product whose use is authorized if all of the following conditions are met:

  • (a) the person holds a foreign product use certificate in respect of that product;

  • (b) that certificate holder purchases the product directly from the foreign source without the intervention of an agent or mandatary;

  • (c) before the importation, the certificate holder provides the Minister with all of the following information:

    • (i) the proposed date of the importation,

    • (ii) the name of the person who will transport the foreign product into Canada, and

    • (iii) the name of the entry point;

  • (d) the certificate holder

    • (i) affixes to each container of the foreign product, as soon as practicable after the importation of the product but in any case no later than upon its arrival either at the location of storage, or at the location of use specified in the foreign product use certificate, a copy of the approved foreign product use label in a way that the product identifier that relates to its registration outside Canada remains visible at all times, and

    • (ii) ensures that a copy of any brochure or leaflet that sets out the directions for use accompanies the product; and

  • (e) the quantity of the product imported does not exceed the amount set out in the foreign product use certificate.

• Marginal note:Pooled purchases

  (2) Two or more persons may together import in one shipment their authorized quantities of foreign products set out in their respective foreign product use certificates if the importation meets the conditions of subsection (1).

• Marginal note:Transport

  (3) The person who transports the foreign product into Canada must carry it to either the location of storage, or the location of use specified in the foreign product use certificate, and have the following documents in their possession:

  • (a) proof of purchase in respect of each quantity of foreign product in the shipment, including the name of the foreign source from whom it was purchased; and

  • (b) copies of all of the relevant foreign product use certificates.

Register

Marginal note:Information in Register

43 The Minister must place all of the following information in the Register with respect to every request for the determination of equivalency made under section 38:

• (a) the name of the person who made the request and the date on which it was made;

• (b) the name of the registered pest control product and its registration number;

• (c) the name of the foreign product, its product identifier and the name of the country where it is registered; and

• (d) the outcome of the request, including the reasons.

Records

Marginal note:Requirements

• 44 (1) The holder of a foreign product use certificate must keep records that contain all of the following information in respect of each foreign product that they import and use:

  • (a) a copy of the certificate;

  • (b) the name and quantity of the foreign product;

  • (c) the method of empty container disposal;

  • (d) the method of disposal of any unused foreign product;

  • (e) proof of purchase of the foreign product and the name of the foreign source from which it was purchased;

  • (f) the name of the person who transported the foreign product into Canada; and

  • (g) the date of importation.

• Marginal note:Retention

  (2) The records must be kept for five years after the end of the year in which the foreign product use certificate that relates to the product expires or ceases to be valid.

• Marginal note:Production of records

  (3) The records must be made available to the Minister on request.