Additional Information and Mandatory Reporting

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.

Condition of registration

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

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.

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.

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

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.

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.

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.

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.

Provision of information when 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) where 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 made under paragraph 67(1)(h), permit another registrant to use or rely on that information to meet the requirements of those provisions.

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.

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.

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.

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.

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.

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.

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.

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.

Provision of information when 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) where 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 made under paragraph 67(1)(h), permit another registrant to use or rely on that information to meet the requirements of those provisions.

Evaluation of pest control product

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

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.

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.

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.

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.

Representatio ns

(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.

Cancellation or amendment

20. (1) The Minister may cancel or amend the registration of a pest control product if

    (a) the registrant fails to satisfy a requirement under subsection 16(3) or 18(1) or paragraph 19(1)(a); or

    (b) in the course of a re-evaluation or special review, the Minister has reasonable grounds to believe that the cancellation or amendment is necessary to deal with a situation that endangers human health or safety or the environment, taking into account the precautionary principle set out in subsection (2).

Precautionary principle

(2) Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent adverse health impact or environmental degradation.

Rescission of action

(3) The Minister may rescind any action taken under subsection (1) if the circumstances that prompted it cease to exist.

Refusal to consider applications

(4) If the registration of a pest control product is cancelled or amended under paragraph (1)(a), the Minister may, for a prescribed period, refuse to consider any application made in respect of that product by the registrant.

Confirmation

21. (1) If the Minister considers that the health and environmental risks and the value of a pest control product are acceptable after any required evaluations and consultations have been completed, the Minister shall confirm the registration.

Amendment or cancellation

(2) If the Minister does not consider that the health or environmental risks or value of a pest control product are acceptable, the Minister shall

    (a) amend the registration if the Minister considers that the health and environmental risks and value of the product would be acceptable after the amendment; or

    (b) cancel the registration.

Delay of effective date

(3) The Minister may delay the effective date of the amendment or cancellation if

    (a) no suitable alternative to the use of the pest control product is available; and

    (b) the Minister considers that the health and environmental risks and value of the product are acceptable until the effective date of the amendment or cancellation.

Conditions on delay

(4) A delay is subject to any conditions that the Minister considers necessary for carrying out the purposes of this Act.

Continued possession, etc., of existing stocks

(5) When cancelling the registration of a pest control product under this section or any other provision of this Act, the Minister may

    (a) allow the continued possession, handling, storage, distribution and use of stocks of the product in Canada at the time of cancellation, subject to any conditions, including disposal procedures, that the Minister considers necessary for carrying out the purposes of this Act;

    (b) require the registrant to recall and dispose of the product in a manner specified by the Minister; or

    (c) seize and dispose of the product.

Other Grounds for Cancellation or Amendment

Discontinuati on of sale of product

22. (1) A registrant who intends to discontinue the sale of a pest control product for one or more uses for which it is registered shall notify the Minister of that intention in the form and manner directed by the Minister.

Reasons for discontinuatio n

(2) The Minister may deliver a notice in writing to the registrant requiring the registrant to explain the reasons for the discontinuation.

Cancellation or amendment of registration

(3) On receipt of notification under subsection (1), the Minister shall cancel or amend the registration, as the case may be, as of a date to be determined by the Minister and, pending that date, may impose any conditions that the Minister considers necessary for carrying out the purposes of this Act.

Non-payment of fees, fines, etc.

23. (1) If a registrant fails to pay a fee, fine, penalty, charge or cost that the registrant is liable to pay under or in relation to this Act, the Minister may

    (a) cancel or amend any registration in the registrant's name; and

    (b) refuse to consider any application made by the registrant under this Act.

Representatio ns

(2) Before taking any action under subsection (1) in relation to charges or costs, the Minister shall give the registrant a reasonable opportunity to make representations.

Notice

(3) The Minister shall immediately give written notice to the registrant of any action taken under subsection (1) and of the reasons for the action.

Amendment with consent

24. The Minister may, with the written consent of the registrant, amend the registration of a pest control product for the purpose of reducing its health or environmental risks or increasing its value.

Breach of conditions

25. The Minister may cancel or amend the registration of a pest control product if the registrant does not comply with the conditions of registration.

Violation or offence

26. If a person is found to have committed a violation or is convicted of an offence under this Act, the Minister may, having regard to the nature of the violation or offence and the circumstances surrounding its commission,

    (a) cancel or amend the registration of the pest control product that was involved in the violation or offence where the person who committed the violation or offence is the registrant;

    (b) cancel or amend the registration of any other pest control product in respect of which the person is the registrant; or

    (c) refuse to consider any application made under this Act by the person during any period that the Minister considers appropriate.

Implementatio n of international agreement

27. The Governor in Council may, by order, cancel or amend the registration of a pest control product or a class of pest control products if the Governor in Council considers it necessary to do so to implement an international agreement.