REGISTRATION OF PEST CONTROL PRODUCTS
Applications for Registration or Amendment
Marginal note:Application to Minister
7. (1) An application to register a pest control product or to amend the product’s registration must be made to the Minister in the form and manner directed by the Minister and must include any information or other thing that is required by the regulations to accompany the application.
Marginal note:Use of information provided by other registrants
(2) If the Minister is satisfied that any information referred to in subsection (1) has been provided by a registrant of a pest control product, the active ingredient of which the Minister has determined to be equivalent to the active ingredient in the applicant’s product, the Minister shall, subject to and in accordance with the regulations made under paragraph 67(1)(h), permit the applicant to use or rely on that information.
Marginal note:Foreign review or evaluation
(2.1) For the purposes of subsection (1), the applicant may include information that is available from a review or evaluation of a pest control product conducted by the government of another member country of the Organisation for Economic Co-operation and Development if the proposed use of the pest control product in Canada would be under conditions similar to those under which the foreign review or evaluation was conducted.
Marginal note:Evaluation of pest control product
(3) If the Minister is satisfied that the application has been made in accordance with subsection (1), (2) or (2.1), the Minister shall
(a) in accordance with the regulations, if any, conduct any evaluations that the Minister considers necessary with respect to the health or environmental risks or the value of the pest control product;
(b) expedite evaluations with respect to a pest control product that may reasonably be expected to pose lower health or environmental risks; and
(c) carry out any consultation required by section 28.
Marginal note:Other information
(4) The Minister may, by delivering a notice in writing, request an applicant to provide the Minister with other information in support of the application within the time and in the form specified in the notice.
Marginal note:Denial of application
(5) The Minister shall deny an application if the applicant does not comply with a notice under subsection (4).
Marginal note:Burden of persuasion and consideration of information
(6) During an evaluation,
(a) the applicant has the burden of persuading the Minister that the health and environmental risks and the value of the pest control product are acceptable; and
(b) the Minister shall consider the information provided by the applicant in support of the application and may consider additional information, but the Minister shall give the applicant a reasonable opportunity to make representations in respect of the additional information before completing the evaluation.
Marginal note:Scientific approach
(7) In evaluating the health and environmental risks of a pest control product and in determining whether those risks are acceptable, the Minister shall
(a) apply a scientifically based approach; and
(b) in relation to health risks, if a decision referred to in paragraph 28(1)(a) or (b) is being made or has been made in relation to a pest control product,
(i) among other relevant factors, consider available information on aggregate exposure to the pest control product, namely dietary exposure and exposure from other non-occupational sources, including drinking water and use in and around homes and schools, and cumulative effects of the pest control product and other pest control products that have a common mechanism of toxicity,
(ii) apply appropriate margins of safety to take into account, among other relevant factors, the use of animal experimentation data and the different sensitivities to pest control products of major identifiable subgroups, including pregnant women, infants, children, women and seniors, and
(iii) in the case of a threshold effect, if the product is proposed for use in or around homes or schools, apply a margin of safety that is ten times greater than the margin of safety that would otherwise be applicable under subparagraph (ii) in respect of that threshold effect, to take into account potential pre- and post-natal toxicity and completeness of the data with respect to the exposure of, and toxicity to, infants and children unless, on the basis of reliable scientific data, the Minister has determined that a different margin of safety would be appropriate.
Marginal note:Government policy to be given effect in evaluation
(8) In evaluating the health and environmental risks and the value of a pest control product, the Minister shall give effect to government policy.
Marginal note:Comparative risk and value assessment
(9) In determining whether the health and environmental risks and the value of a pest control product are acceptable, the Minister may, in accordance with the regulations, if any, take into account information regarding the risks and value of other pest control products that are registered for the same use.
(10) For the purposes of subsection (9), the Minister shall, before making the determination, give the applicant a reasonable opportunity to make representations in respect of the information referred to in that subsection.
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