Pest Control Products Act (S.C. 2002, c. 28)

Additional Information and Mandatory Reporting

Marginal note:Additional information

• 12 (1) The Minister may, by delivering a notice in writing, require a registrant

  • (a) to compile information, conduct tests and monitor experience with the pest control product for the purpose of obtaining additional information with respect to its effects on human health and safety or the environment or with respect to its value; and

  • (b) to report the additional information to the Minister within the time and in the form specified in the notice.

• Marginal note:Condition of registration

  (2) A requirement under subsection (1) is a condition of registration.

Marginal note:Mandatory reporting

13 An applicant for registration of a pest control product, a person who makes an application under subsection 10(2) or a registrant shall report any prescribed information that relates to the health or environmental risks or the value of the pest control product to the Minister within the prescribed time and in the form and manner directed by the Minister.

Marginal note:Determination by Minister

14 After considering any information reported under section 12 or 13, the Minister shall determine whether a special review of the registration of the pest control product should be initiated.

Marginal note:Public availability

15 After considering any information reported under section 13, the Minister shall place his or her conclusions in the Register and shall make public those conclusions if, in the Minister’s opinion,

• (a) the pest control product poses a significant health or environmental risk; or

• (b) it is in the public interest to do so.

Re-evaluation and Special Review

Marginal note:Minister’s discretion to initiate re-evaluation

• 16 (1) The Minister may initiate the re-evaluation of a registered pest control product if the Minister considers that, since the product was registered, there has been a change in the information required, or the procedures used, for the evaluation of the health or environmental risks or the value of pest control products of the same class or kind.

• Marginal note:Minister required to initiate re-evaluation

  (2) Without limiting the generality of subsection (1),

  • (a) if a decision of a type referred to in paragraph 28(1)(a) or (b) was made in relation to a pest control product on or after April 1, 1995, the Minister shall initiate a re-evaluation of that product no later than one year after 15 years have elapsed since the most recent decision of that type; and

  • (b) if the most recent decision of a type referred to in paragraph 28(1)(a) or (b) was made in relation to a pest control product before April 1, 1995, the Minister shall initiate a re-evaluation of that product no later than April 1, 2005 or the date that is one year after 15 years have elapsed since that decision, whichever date is later.

• Marginal note:Notice requesting information

  (3) Re-evaluation of a pest control product is initiated by the Minister delivering a notice in writing to the registrant explaining the reasons for initiating the re-evaluation and, if considered necessary by the Minister, requiring the registrant to provide information in the form and within the period specified in the notice.

• Marginal note:Request for information from departments and provinces

  (4) After the re-evaluation is initiated, the Minister shall deliver a notice to federal and provincial government departments and agencies whose interests and concerns are affected by the federal regulatory system requesting them to provide, in the form and within the period specified in the notice, information in respect of the health and environmental risks and the value of the product that is under re-evaluation.

• Marginal note:Provision of information if more than one registrant

  (5) If there is more than one registrant whose registered pest control products have active ingredients that the Minister has determined to be equivalent,

  • (a) two or more registrants may provide the information required under subsection (3) or paragraph 19(1)(a) jointly; and

  • (b) if the Minister is satisfied that the information required under subsection (3) or paragraph 19(1)(a) has been provided by one or more registrants, the Minister shall, subject to and in accordance with the regulations, permit another registrant to use or rely on that information to meet the requirements under that subsection or paragraph.

• Marginal note:If active ingredients not equivalent

  (5.1) If the active ingredients of the registered pest control product that is subject to the re-evaluation are not equivalent to the active ingredients in another registrant’s registered pest control product, the Minister shall, subject to and in accordance with the regulations, permit the registrant whose product is subject to the re-evaluation to use or rely on information provided by the other registrant if the Minister is satisfied that the information is necessary for the re-evaluation.

• Marginal note:Evaluation of pest control product

  (6) After the re-evaluation is initiated, the Minister shall, 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 and shall carry out the consultations required by section 28.

Marginal note:Initiation of special review by Minister

• 17 (1) The Minister shall initiate a special review of the registration of a pest control product if the Minister has reasonable grounds to believe that the health or environmental risks of the product are, or its value is, unacceptable.

• Marginal note:Special review where OECD ban

  (2) Without limiting the generality of subsection (1), when a member country of the Organisation for Economic Co-operation and Development prohibits all uses of an active ingredient for health or environmental reasons, the Minister shall initiate a special review of registered pest control products containing that active ingredient.

• Marginal note:Special review where information from department or province

  (3) Without limiting the generality of subsection (1), the Minister shall initiate a special review of the registration of a pest control product if a federal or provincial government department or agency has provided information to the Minister that relates to the health or environmental risks or the value of the product and if, after considering the information provided, the Minister has reasonable grounds to believe that the health or environmental risks of the product are, or its value is, unacceptable.

• Marginal note:Request for special review

  (4) Any person may request a special review of the registration of a pest control product by making a request to the Minister in the form and manner directed by the Minister.

• Marginal note:Decision

  (5) Within a reasonable time after receiving a request, the Minister shall decide whether to initiate a special review and shall respond to the request with written reasons for the decision.

• Marginal note:Scope of special review

  (6) For the purposes of this section, the Minister shall initiate a special review only in relation to the aspect of the pest control product that prompted the special review.

• Marginal note:Addition of aspect

  (7) If the Minister has initiated a re-evaluation of, or a special review in relation to, a pest control product, the Minister may, at any time before the decision statement is made public under subsection 28(5), expand the scope of the re-evaluation or special review to include any aspect of the product that would otherwise prompt a new special review under subsection (1), (2) or (3).

• Marginal note:New or amended consultation statement

  (8) If the Minister expands the scope of a re-evaluation or special review under subsection (7) after the consultation statement relating to the re-evaluation or special review has been made public under subsection 28(2), the Minister shall make public a new or amended consultation statement under that subsection that takes into account the aspect referred to in subsection (7).

Marginal note:Discretion of Minister — aspect already covered

• 17.1 (1) Despite section 17, the Minister may decide not to initiate a special review in relation to a pest control product if a re-evaluation of, or a special review in relation to, the product has already been initiated that includes the aspect of the product that would otherwise prompt a special review.

• Marginal note:Discretion of Minister — previous decision statement

  (2) Despite subsection 17(2), the Minister may decide not to initiate a special review of a registered pest control product under that subsection if

  • (a) the Minister made public under subsection 28(5) a decision statement respecting a re-evaluation of, or a special review in relation to, that product;

  • (b) the aspect of the product that would otherwise prompt a special review was addressed by the re-evaluation or special review referred to in paragraph (a); and

  • (c) the Minister determines that there is no additional information in relation to the health or environmental risks of the product that provides the Minister with reasonable grounds to believe that those risks are unacceptable.

Marginal note:Duty to make decisions public

17.2 The Minister shall make public each of the following decisions and the reasons for it:

• (a) a decision made under subsection 17(7) to expand the scope of a re-evaluation or special review to include an aspect that would otherwise prompt a new special review under subsection 17(2);

• (b) a decision made under subsection 17.1(1) or (2) not to initiate a special review in relation to an aspect that would otherwise prompt such a review under subsection 17(2).

Marginal note:Notice requesting information

• 18 (1) A special review of a pest control product is initiated by the Minister delivering a notice in writing to the registrant explaining the reasons for initiating the special review and, if considered necessary by the Minister, requiring the registrant to provide information in the form and within the period specified in the notice.

• Marginal note:Request for information from departments and provinces

  (2) After the special review is initiated, the Minister shall deliver a notice to federal and provincial government departments and agencies whose interests and concerns are affected by the federal regulatory system requesting them to provide, in the form and within the period specified in the notice, information in respect of the health and environmental risks and the value of the product that is under special review.

• Marginal note:Provision of information if more than one registrant

  (3) If there is more than one registrant whose registered pest control products have active ingredients that the Minister has determined to be equivalent,

  • (a) two or more registrants may provide the information required under subsection (1) or paragraph 19(1)(a) jointly; and

  • (b) if the Minister is satisfied that the information required under subsection (1) or paragraph 19(1)(a) has been provided by one or more registrants, the Minister shall, subject to and in accordance with the regulations, permit another registrant to use or rely on that information to meet the requirements under that subsection or paragraph.

• Marginal note:If active ingredients not equivalent

  (3.1) If the active ingredients of a registered pest control product that is subject to the special review are not equivalent to the active ingredients in another registrant’s registered pest control product, the Minister shall, subject to and in accordance with the regulations, permit the registrant whose product is subject to the special review to use or rely on information provided by the other registrant if the Minister is satisfied that the information is necessary for the special review.

• Marginal note:Evaluation of pest control product

  (4) After the special review is initiated, the Minister shall, in accordance with the regulations, if any, evaluate only the aspects of the pest control product that are within the scope of the special review and shall carry out the consultations required by section 28.

Marginal note:Burden of persuasion and consideration of information

• 19 (1) During an evaluation that is done in the course of a re-evaluation or special review,

  • (a) the Minister may, by delivering a notice in writing, require the registrant to provide, in the form and within the period specified in the notice, additional information that the Minister considers necessary for the evaluation;

  • (b) the registrant has the burden of persuading the Minister that the health and environmental risks and the value of the pest control product are acceptable; and

  • (c) the Minister shall consider the information provided by the registrant in support of the product and may consider any additional information, but the Minister shall give the registrant a reasonable opportunity to make representations in respect of the additional information before completing the evaluation.

• Marginal note:Scientific approach

  (2) 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,

    • (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 used 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

  (3) 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

  (4) 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.

• Marginal note:Representations

  (5) For the purposes of subsection (4), the Minister shall, before making the determination, give any registrant whose product is under re-evaluation or special review a reasonable opportunity to make representations in respect of the information referred to in that subsection.