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Bill C-53

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HER MAJESTY

Binding on Her Majesty

3. This Act is binding on Her Majesty in right of Canada or a province.

MANDATE

Primary objective

4. (1) In the administration of this Act, the Minister's primary objective is to prevent unacceptable risks to people and the environment from the use of pest control products.

Ancillary objectives

(2) Consistent with, and in furtherance of, the primary objective, the Minister shall

    (a) support sustainable development designed to enable the needs of the present to be met without compromising the ability of future generations to meet their own needs;

    (b) seek to minimize health and environmental risks posed by pest control products and encourage the development and implementation of innovative, sustainable pest management strategies by facilitating access to pest control products that pose lower risks and by other appropriate measures;

    (c) encourage public awareness in relation to pest control products by informing the public, facilitating public access to relevant information and public participation in the decision-making process; and

    (d) ensure that only those pest control products that are determined to be of acceptable value are approved for use in Canada.

Protection of future generations

4.1 For greater certainty, protection and consideration afforded to children in this Act shall also extend to future generations.

ADVISORY COUNCIL

Establishment

5. (1) In carrying out duties under this Act, the Minister may establish an advisory council of persons whose interests and concerns are affected by this Act, and may specify the functions of the council and the means by which it is to perform those functions.

Report to Minister

(2) The advisory council shall give any report that it makes, including its recommendations and the reasons for them, to the Minister, who shall place it in the Register.

PROHIBITIONS

Unregistered pest control products

6. (1) No person shall manufacture, possess, handle, store, transport, import, distribute or use a pest control product that is not registered under this Act, except as otherwise authorized under subsection 21(5) or 41(1), any of sections 53 to 59 or the regulations.

Conditions of registration

(2) No person shall manufacture, import, export or distribute a registered pest control product unless it conforms to the conditions of registration respecting its composition and the person complies with the other conditions of registration.

Packaging of pest control products

(3) No person shall store, import, export or distribute a pest control product that is not packaged in accordance with the regulations and the conditions of registration.

Defence

(4) A person shall not be found to have contravened subsection (3) if it is established that the person reasonably believed that the pest control product was packaged in accordance with the regulations and the conditions of registration.

Misuse of pest control products

(5) No person shall handle, store, transport, use or dispose of a pest control product in a way that is inconsistent with

    (a) the regulations; or

    (b) if the product is registered, the directions on the label recorded in the Register, subject to the regulations.

Defence

(6) A person shall not be found to have contravened subsection (5) if it is established that the person

    (a) reasonably believed that the directions on the label accompanying the pest control product complied with the regulations or, if the product is registered, with the directions on the label recorded in the Register; and

    (b) handled, stored, transported, used or disposed of the product in accordance with the directions on the label accompanying it.

Packaging and advertisement of pest control products

(7) No person shall package or advertise a pest control product in a way that is false, misleading or likely to create an erroneous impression regarding its character, value, quantity, composition, safety or registration.

Activities that endanger health, etc.

(8) No person shall manufacture, possess, handle, store, transport, distribute, use or dispose of a pest control product in a way that endangers human health or safety or the environment.

Offence and punishment

(9) A person who contravenes any provision of this section is guilty of an offence and liable

    (a) on summary conviction, to a fine of not more than $200,000 or to imprisonment for a term of not more than six months, or to both; or

    (b) on conviction on indictment, to a fine of not more than $500,000 or to imprisonment for a term of not more than three years, or to both.

REGISTRATION OF PEST CONTROL PRODUCTS

Applications for Registration or Amendment

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.

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.

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.

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.

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.

Denial of application

(5) The Minister shall deny an application if the applicant does not comply with a notice under subsection (4).

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.

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.

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.

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.

Representatio ns

(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.

Registration or amendment

8. (1) If the Minister considers that the health and environmental risks and the value of the pest control product are acceptable after any required evaluations and consultations have been completed, the Minister shall register the product or amend its registration in accordance with the regulations, if any, by

    (a) specifying the conditions relating to its manufacture, handling, storage, transport, import, export, packaging, distribution, use or disposal, including conditions relating to its composition and, subject to subsection (2), its label;

    (b) assigning a registration number to the product in the case of a new registration and, where the Minister considers it appropriate, in the case of an amendment; and

    (c) specifying the period for which the registration or amended registration is valid, which period may be either finite or indefinite.

Conditions relating to label

(2) The Minister may specify conditions relating to the label of a pest control product, otherwise than in accordance with the regulations, if the Minister is satisfied that the purposes of this Act can be met by so doing.

Provision of safety information to workplaces

(3) Without limiting the generality of paragraph (1)(a), the Minister shall specify, as a condition of registration, the requirement for product safety information, including a material safety data sheet for the product, to be provided to workplaces where the pest control product is used or manufactured, in accordance with the regulations made under paragraph 67(1)(s).

Denial of application

(4) The Minister shall deny an application referred to in subsection 7(1) if the Minister does not consider that the health or environmental risks of a pest control product are, or its value is, acceptable.

Sales data

(5) A registrant of a pest control product shall, as a condition of registration, record, retain and report to the Minister information on sales of the product in the form and manner directed by the Minister and in accordance with the regulations made under paragraph 67(1)(u).

Former registrants

(6) The obligation under subsection (5) to retain and report sales information in respect of a pest control product continues to apply to a former registrant after that product ceases to be registered.

Maximum Residue Limits

Specification at time of registration decision

9. When making a decision regarding the registration of a pest control product, the Minister shall, if necessary, specify any maximum residue limits for the product or for its components or derivatives that the Minister considers appropriate in the circumstances.

Specification for unregistered products and uses

10. (1) The Minister may specify maximum residue limits for an unregistered pest control product or its components or derivatives, or for a registered pest control product or its components or derivatives with respect to a use that is not provided for by its registration, whether or not an application under subsection (2) is made for that purpose.

Application for specification

(2) Any person may make an application to the Minister to specify maximum residue limits pursuant to subsection (1). Section 7, with any necessary modifications, applies to that application.

Evaluation of health risks

(3) When specifying maximum residue limits for a pest control product or its components or derivatives pursuant to subsection (1), the Minister shall evaluate only the health risks of the product or its components or derivatives.

Health risks to be considered acceptable

11. (1) The health risks associated with maximum residue limits specified by the Minister under sections 9 and 10 must be considered to be acceptable by the Minister.

Relevant factors

(2) 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, the Minister shall, in evaluating and determining whether the health risks associated with maximum residue limits for that pest control product or its components or derivatives are acceptable under subsection (1),

    (a) among other relevant factors, consider available information on

      (i) 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,

      (ii) cumulative effects of the pest control product and other pest control products that have a common mechanism of toxicity, and

      (iii) the different sensitivities to pest control products of major identifiable subgroups, including pregnant women, infants, children, women and seniors; and

    (b) in the case of a threshold effect, apply a margin of safety that is ten times greater than the margin of safety that would otherwise be applicable under subparagraph 7(7)(b)(ii) or 19(2)(b)(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.