Pest Control Products Regulations — 38
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). 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. 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. Interpretation — test data (3.1) In subsection (3), test data has the same meaning as in section 17.01. 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. 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 informatio