Pest Control Products Act

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Sections768

• 1Short title

  This Act may be cited as the Pest Control Products Act.

• 2Definitions
• 2(1)

  The definitions in this subsection apply in this Act.

• 2(1)[p3]

  active ingredient means a component of a pest control product to which the intended effects of the product are attributed and includes a synergist but does not include a solvent, diluent, emulsifier or other component that is not primarily responsible for those effects. (principe actif)

• 2(1)[p4]

  advertise includes making a representation by any means for the purpose of directly or indirectly promoting the distribution of a pest control product. (publicité)

• 2(1)[p5]

  analyst means an individual who is appointed or designated as an analyst under section 45. (analyste)

• 2(1)[p6]

  biological diversity means the variability among living organisms from all sources, including, without limiting the generality of the foregoing, terrestrial and marine and other aquatic ecosystems and the ecological complexes of which they form a part and includes the diversity within and between species and of ecosystems. (diversité biologique)

• 2(1)[p7]

  biotechnology means the application of science and engineering in the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms. (biotechnologie)

• 2(1)[p8]

  conditions of registration means

• 2(1)[p8](a)

  any conditions specified by the Minister under paragraph 8(1)(a) or subsection 8(2) or when amending the registration of a pest control product under this Act; and

• 2(1)[p8](b)

  any other requirements stated by this Act or the regulations to be conditions of registration. (conditions d’homologation)

• 2(1)[p11]

  confidential business information means information to which access may be refused under the Access to Information Act and that meets the requirements of subsection 43(4) or (5). (renseignements commerciaux confidentiels)

• 2(1)[p12]

  confidential test data means test data to which access may be refused under the Access to Information Act. (données d’essai confidentielles)

• 2(1)[p13]

  distribute means distribute in any way, whether or not for consideration, and includes sell, offer for sale or distribution, and expose, display or advertise for sale or distribution. (distribution)

• 2(1)[p14]

  document means anything on which information that is capable of being understood by a person, or read by a computer or other device, is recorded or marked. (document)

• 2(1)[p15]

  ecosystem means a dynamic complex of plant, animal and micro-organism communities and their non-living environment interacting as a functional unit. (écosystème)

• 2(1)[p16]

  environment means the components of the Earth and includes

• 2(1)[p16](a)

  air, land and water;

• 2(1)[p16](b)

  all layers of the atmosphere;

• 2(1)[p16](c)

  all organic and inorganic matter and living organisms; and

• 2(1)[p16](d)

  the interacting natural systems that include components referred to in paragraphs (a) to (c). (environnement)

• 2(1)[p21]

  environmental risk, in respect of a pest control product, means the possibility of harm to the environment, including its biological diversity, resulting from exposure to or use of the product, taking into account its conditions or proposed conditions of registration. (risque environnemental)

• 2(1)[p22]

  formulant means any component of a pest control product that is added intentionally to the product and that is not an active ingredient. (formulant)

• 2(1)[p23]

  government policy means the Toxic Substances Management Policy issued by the Government of Canada in June, 1995, as long as it remains in effect, and any other policies of the Government of Canada that are prescribed. (politique gouvernementale)

• 2(1)[p24]

  health risk, in respect of a pest control product, means the possibility of harm to human health resulting from exposure to or use of the product, taking into account its conditions or proposed conditions of registration. (risque sanitaire)

• 2(1)[p25]

  inspector means an individual who is appointed or designated as an inspector under section 45. (inspecteur)

• 2(1)[p26]

  label includes any written, printed or graphic matter

• 2(1)[p26](a)

  that is or is to be applied or attached to or included in, or that accompanies or is to accompany, a pest control product or a package; or

• 2(1)[p26](b)

  that belongs to a pest control product and is transmitted electronically, in accordance with the regulations. (étiquette)

• 2(1)[p29]

  manufacture includes produce, formulate, package, label and prepare for distribution or use. (fabrication)

• 2(1)[p30]

  Minister means the Minister of Health. (ministre)

• 2(1)[p31]

  package includes a container, wrapping, covering or holder in which a pest control product is wholly or partly contained, placed or packed. (emballage)

• 2(1)[p32]

  penalty means an administrative monetary penalty imposed under the Agriculture and Agri-Food Administrative Monetary Penalties Act for a violation. (pénalité)

• 2(1)[p33]

  person means Her Majesty, an individual or an organization as defined in section 2 of the Criminal Code. (personne)

• 2(1)[p34]

  pest means an animal, a plant or other organism that is injurious, noxious or troublesome, whether directly or indirectly, and an injurious, noxious or troublesome condition or organic function of an animal, a plant or other organism. (parasite)

• 2(1)[p35]

  pest control product means

• 2(1)[p35](a)

  a product, an organism or a substance, including a product, an organism or a substance derived through biotechnology, that consists of its active ingredient, formulants and contaminants, and that is manufactured, represented, distributed or used as a means for directly or indirectly controlling, destroying, attracting or repelling a pest or for mitigating or preventing its injurious, noxious or troublesome effects;

• 2(1)[p35](b)

  an active ingredient that is used to manufacture anything described in paragraph (a); or

• 2(1)[p35](c)

  any other thing that is prescribed to be a pest control product. (produit antiparasitaire)

• 2(1)[p39]

  place includes a means of transport. (lieu)

• 2(1)[p40]

  prescribed means prescribed by regulation. (Version anglaise seulement)

• 2(1)[p41]

  Register means the Register of Pest Control Products established and maintained under section 42. (Registre)

• 2(1)[p42]

  registrant means a person in whose name a pest control product is registered. (titulaire)

• 2(1)[p43]

  test data means scientific or technical information respecting the health or environmental risks or the value of a pest control product. (données d’essai)

• 2(1)[p44]

  threshold effect, in respect of a pest control product, means a harmful effect on human health for which the Minister is able to identify a level at which the product will not cause that effect. (effet de seuil)

• 2(1)[p45]

  value, in respect of a pest control product, means the product’s actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration, and includes the product’s

• 2(1)[p45](a)

  efficacy;

• 2(1)[p45](b)

  effect on host organisms in connection with which it is intended to be used; and

• 2(1)[p45](c)

  health, safety and environmental benefits and social and economic impact. (valeur)

• 2(1)[p49]

  violation means any of the following that may be proceeded with in accordance with the Agriculture and Agri-Food Administrative Monetary Penalties Act:

• 2(1)[p49](a)

  any contravention of any provision of this Act or of a regulation made under this Act; and

• 2(1)[p49](b)

  any refusal or neglect to perform any duty imposed by or under this Act. (violation)

• 2(1)[p52]

  workplace means a place where an individual works for remuneration. (lieu de travail)

• 2(2)Acceptable risks

  For the purposes of this Act, the health or environmental risks of a pest control product are acceptable if there is reasonable certainty that no harm to human health, future generations or the environment will result from exposure to or use of the product, taking into account its conditions or proposed conditions of registration.

• 3Binding on Her Majesty

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

• 4Primary objective
• 4(1)

  In the administration of this Act, the Minister’s primary objective is to prevent unacceptable risks to individuals and the environment from the use of pest control products.

• 4(2)Ancillary objectives

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

• 4(2)(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;

• 4(2)(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;

• 4(2)(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

• 4(2)(d)

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

• 4.1Protection of future generations

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

• 5Establishment
• 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.

• 5(2)Report to Minister

  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.

• 6Unregistered 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), section 48 or 51, any of sections 53 to 59 or the regulations.

• 6(2)Conditions of registration

  Except as otherwise authorized under section 53.3 or 54, 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.

• 6(3)Packaging and labelling

  Except as otherwise authorized under section 53, 53.3 or 54, no person shall store, import, export or distribute a pest control product that is not packaged and labelled in accordance with the regulations and, if it is registered, the conditions of registration.

• 6(4)Repealed

  [Repealed, 2016, c. 9, s. 35]

• 6(5)Misuse of pest control products

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

• 6(5)(a)

  the regulations; or

• 6(5)(b)

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

• 6(6)Repealed

  [Repealed, 2016, c. 9, s. 35]

• 6(7)Packaging, labelling and advertisement

  No person shall package, label 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.

• 6(8)Activities that endanger health, etc.

  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.

• 6(8.1)Alteration, destruction or falsification — required documents

  No person shall alter, destroy or falsify a document that they are required under this Act to keep, maintain or provide.

• 6(8.2)Alteration, possession or use — official documents

  It is prohibited for a person to

• 6(8.2)(a)

  alter a document issued or made — or in any manner given — under this Act; or

• 6(8.2)(b)

  have in their possession, or use, a document issued or made — or in any manner given — under this Act that has been altered.

• 6(8.3)Possession or use of documents that resemble official documents

  It is prohibited for a person to have in their possession, or use, any document that has not been issued or made — or in any manner given — under this Act if the document so resembles a document issued or made — or in any manner given — under this Act that it is likely to be mistaken for such a document.

• 6(9)Offence and punishment

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

• 6(9)(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

• 6(9)(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.

• 7Application 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.

• 7(2)Use of information provided by registrants

  If the Minister determines that the active ingredient of the applicant’s pest control product is equivalent to the active ingredient of a registered pest control product, the Minister shall, subject to and in accordance with the regulations, permit the applicant to use or rely on any information referred to in subsection (1) that has been provided by any registrant if the Minister is satisfied that the information

• 7(2)(a)

  is relevant to the registered pest control product that contains the equivalent active ingredient; and

• 7(2)(b)

  is necessary to support the application.

• 7(2.1)Foreign review or evaluation

  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.

• 7(3)Evaluation of pest control product

  If the Minister is satisfied that the application has been made in accordance with subsection (1), (2) or (2.1), the Minister shall

• 7(3)(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;

• 7(3)(b)

  expedite evaluations with respect to a pest control product that may reasonably be expected to pose lower health or environmental risks; and

• 7(3)(c)

  carry out any consultation required by section 28.

• 7(4)Other information

  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.

• 7(5)Denial of application

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

• 7(6)Burden of persuasion and consideration of information

  During an evaluation,

• 7(6)(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

• 7(6)(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.

• 7(7)Scientific approach

  In evaluating the health and environmental risks of a pest control product and in determining whether those risks are acceptable, the Minister shall

• 7(7)(a)

  apply a scientifically based approach; and

• 7(7)(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,

• 7(7)(b)(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,

• 7(7)(b)(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

• 7(7)(b)(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.

• 7(8)Government policy to be given effect in evaluation

  In evaluating the health and environmental risks and the value of a pest control product, the Minister shall give effect to government policy.

• 7(9)Comparative risk and value assessment

  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.

• 7(10)Representations

  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.

• 8Registration 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

• 8(1)(a)

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

• 8(1)(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

• 8(1)(c)

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

• 8(2)Conditions relating to label

  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.

• 8(3)Provision of safety information to workplaces

  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).

• 8(4)Denial of application

  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.

• 8(5)Sales data

  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).

• 8(6)Former registrants

  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.

• 9Specification at time of registration decision

  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.

• 10Specification 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.

• 10(2)Application for specification

  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.

• 10(3)Evaluation of health risks

  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.

• 11Health 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.

• 11(2)Relevant factors

  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),

• 11(2)(a)

  among other relevant factors, consider available information on

• 11(2)(a)(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,

• 11(2)(a)(ii)

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

• 11(2)(a)(iii)

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

• 11(2)(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.

• 12Additional information
• 12(1)

  The Minister may, by delivering a notice in writing, require a registrant

• 12(1)(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

• 12(1)(b)

  to report the additional information to the Minister within the time and in the form specified in the notice.

• 12(2)Condition of registration

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

• 13Mandatory reporting

  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.

• 14Determination by Minister

  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.

• 15Public availability

  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,

• 15(a)

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

• 15(b)

  it is in the public interest to do so.

• 16Minister’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.

• 16(2)Minister required to initiate re-evaluation

  Without limiting the generality of subsection (1),

• 16(2)(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

• 16(2)(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.

• 16(3)Notice requesting information

  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.

• 16(4)Request for information from departments and provinces

  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.

• 16(5)Provision of information if more than one registrant

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

• 16(5)(a)

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

• 16(5)(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.

• 16(5.1)If active ingredients not equivalent

  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.

• 16(6)Evaluation of pest control product

  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.

• 17Initiation 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.

• 17(2)Special review where OECD ban

  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.

• 17(3)Special review where information from department or province

  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.

• 17(4)Request for special review

  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.

• 17(5)Decision

  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.

• 17(6)Scope of special review

  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.

• 17(7)Addition of aspect

  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).

• 17(8)New or amended consultation statement

  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).

• 17.1Discretion 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.

• 17.1(2)Discretion of Minister — previous decision statement

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

• 17.1(2)(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;

• 17.1(2)(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

• 17.1(2)(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.

• 17.2Duty to make decisions public

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

• 17.2(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);

• 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).

• 18Notice 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.

• 18(2)Request for information from departments and provinces

  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.

• 18(3)Provision of information if more than one registrant

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

• 18(3)(a)

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

• 18(3)(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.

• 18(3.1)If active ingredients not equivalent

  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.

• 18(4)Evaluation of pest control product

  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.

• 19Burden of persuasion and consideration of information
• 19(1)

  During an evaluation that is done in the course of a re-evaluation or special review,

• 19(1)(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;

• 19(1)(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

• 19(1)(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.

• 19(2)Scientific approach

  In evaluating the health and environmental risks of a pest control product and in determining whether those risks are acceptable, the Minister shall

• 19(2)(a)

  apply a scientifically based approach; and

• 19(2)(b)

  in relation to health risks,

• 19(2)(b)(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,

• 19(2)(b)(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

• 19(2)(b)(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.

• 19(3)Government policy to be given effect in evaluation

  In evaluating the health and environmental risks and the value of a pest control product, the Minister shall give effect to government policy.

• 19(4)Comparative risk and value assessment

  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.

• 19(5)Representations

  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.

• 20Cancellation or amendment
• 20(1)

  The Minister may cancel or amend the registration of a pest control product if

• 20(1)(a)

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

• 20(1)(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).

• 20(2)Precautionary principle

  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.

• 20(3)Rescission of action

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