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Pest Control Products Regulations (SOR/2006-124)

Regulations are current to 2022-07-25 and last amended on 2022-06-08. Previous Versions

Application for Registration (continued)

Marginal note:Additional information — affidavit and contents

  •  (1) When, in the context of an application for registration or to amend a registration, the Minister considers additional information under paragraph 7(6)(b) of the Act that is not publicly available, the applicant must be given access to that information by the Minister for the purpose of making representations under that paragraph with respect to the information, if the applicant submits to the Minister an affidavit made under oath or a statutory declaration under the Canada Evidence Act made before a commissioner for oaths or for taking affidavits that

    • (a) identifies the information to which access is being requested;

    • (b) acknowledges that the access is given only for the purpose of enabling the applicant to make representations to the Minister with respect to the information;

    • (c) states that the applicant will not use the information or make it available to any person for any other purpose; and

    • (d) states that the information and any copies of it will be returned to the Minister when the stated purpose has been achieved.

  • Marginal note:Copying or other use

    (2) The applicant to whom access to additional information is given under subsection (1) must not use the information or provide it to any person for any purpose other than to make representations under paragraph 7(6)(b) of the Act with respect to the information.

  • Marginal note:Return of information

    (3) Additional information to which access is given under subsection (1) and any copies of it must be returned to the Minister by the applicant immediately after they have made their representations with respect to the information.

  • SOR/2014-24, s. 7

Marginal note:Reference in Register

 For the purpose of subsection 42(4) of the Act, evaluation reports that are placed in the Register under paragraph 42(2)(f) of the Act must include a reference to information placed in the Register under paragraph 42(2)(e) of the Act.

Marginal note:Samples on request

 On application to register or amend the registration of a pest control product, the applicant must, if requested by the Minister, provide the Minister with a sample of

  • (a) the pest control product;

  • (b) the technical grade of its active ingredient; and

  • (c) the laboratory standard of its active ingredient.

Marginal note:Registration certificate

 When a pest control product is registered or a registration is amended under section 8 of the Act, the Minister must issue a registration certificate that bears the registration number of the pest control product and sets out any conditions of registration specified by the Minister.

Validity Period

Marginal note:Maximum validity period

 The validity period of a registration of a pest control product must end no later than December 31 in the fifth year after the year in which the product is registered.

  • SOR/2017-91, s. 3

 [Repealed, SOR/2017-91, s. 4]

 [Repealed, SOR/2017-91, s. 4]

Renewal of Registration

Marginal note:Five-year periods

  •  (1) The registration of a pest control product may be renewed, on application by the registrant to the Minister, for additional periods of not more than five years each.

  • Marginal note:Renewal applications

    (2) An application to renew the registration of a pest control product must be accompanied by the following:

    • (a) the information required by subsection 6(1);

    • (b) the statement required by subsection 6(3);

    • (c) the information required by section 8; and

    • (d) in the case of a registration certificate that was issued in the circumstances described in sections 17.7 to 17.94, a copy of the valid letter of access, as defined in section 17.1.

  • Marginal note:Request — labels

    (3) The registrant must, if requested by the Minister, provide the Minister with an electronic copy of the approved label and two hard copies of the marketplace label.

  • SOR/2010-119, s. 1
  • SOR/2017-91, s. 5

Re-evaluations and Special Reviews

Marginal note:Additional information — affidavit and contents

  •  (1) When, in the context of a re-evaluation or special review, the Minister considers additional information under paragraph 19(1)(c) of the Act that is not publicly available, the registrant must be given access to that information by the Minister for the purpose of making representations under that paragraph with respect to the information, if the registrant submits to the Minister an affidavit made under oath or a statutory declaration under the Canada Evidence Act made before a commissioner for oaths or for taking affidavits that

    • (a) identifies the information to which access is being requested;

    • (b) acknowledges that the access is given only for the purpose of enabling the registrant to make representations to the Minister with respect to the information;

    • (c) states that the registrant will not use the information or make it available to any person for any other purpose; and

    • (d) states that the information and any copies of it will be returned to the Minister when the stated purpose has been achieved.

  • Marginal note:Copying or other use

    (2) The registrant to whom access to additional information is given under subsection (1) must not use the information or provide it to any person for any purpose other than to make representations under paragraph 19(1)(c) of the Act with respect to the information.

  • Marginal note:Return of information

    (3) Additional information to which access is given under subsection (1) and any copies of it must be returned to the Minister by the registrant immediately after they have made their representations with respect to the information.

  • SOR/2014-24, s. 8

Protection of Test Data

Interpretation

Marginal note:Definitions

 The following definitions apply in sections 17.2 to 17.94.

agreement

agreement means an agreement described in subsection 66(1) of the Act. (entente)

compensable data

compensable data means test data other than the following:

  • (a) test data that was submitted to support the registration of a new active ingredient and the pest control products associated with that ingredient, including any test data that was part of the additional information reported under section 12 of the Act in relation to that ingredient and those products;

  • (b) test data that is included in a scientific study that has been published; and

  • (c) test data that is generated by a scientific study that is fully funded by a government or one of its institutions. (données soumises à des droits d’utilisation)

crop group

crop group means a group of crops in which the residues at harvest are similar, based on similarities in appearance, harvestable commodity, edible portions and growth habits. (groupe de cultures)

letter of access

letter of access means a document that is signed by a registrant in which the registrant authorizes a named person to use or rely on identified test data. (lettre d’accès)

letter of confirmation of source

letter of confirmation of source means a document that is signed by a registrant in which the registrant confirms that they have agreed to provide an identified registered pest control product to a named person. (lettre de confirmation de source)

minor use

minor use, in respect of a pest control product, means a use the demand for which originates with a grower or a group of growers and which product is intended to be used on a particular pest in connection with a particular host organism, in all of the following circumstances:

  • (a) the use is for an agricultural purpose;

  • (b) a federal or provincial agricultural authority supports the use; and

  • (c) the use is supported by crop residue data or dislodgeable foliar data. (usage limité)

representative crop

representative crop means a crop in a crop group from which extrapolations of residue levels and maximum residue limits may be made to one or more crops in the group. (culture répresentative)

test data

test data means test data that is included in the information used by the Minister in any of the following circumstances:

  • (a) to support an application to register a pest control product or to amend a registration under section 7 or 12 of the Act;

  • (b) to support a re-evaluation under section 16 of the Act or a special review under section 17 of the Act and that is submitted in response to a notice delivered to the registrant under subsection 16(3), 18(1) or 19(1) of the Act; or

  • (c) in support of a registration before June 28, 2006. (données d’essai)

  • SOR/2010-119, s. 2
  • SOR/2017-169, s. 1

Application

Marginal note:Equivalent active ingredients

 Sections 17.1 and 17.3 to 17.94 apply to applications to register a pest control product whose active ingredient has been determined by the Minister under subsection 7(2) of the Act to be equivalent to the active ingredient of a registered pest control product.

  • SOR/2010-119, s. 2
  • SOR/2016-61, s. 2

Marginal note:Re-evaluations and special reviews

 Sections 17.1, 17.2 and 17.4 to 17.94 apply, with any necessary modifications, to a registrant who wishes to use or rely on test data of another registrant for the purpose of subsection 16(5), (5.1), 18(3) or (3.1) of the Act.

  • SOR/2010-119, s. 2
  • SOR/2017-169, s. 2

Marginal note:Non-application — product copies

 When an applicant wishes to use or rely on test data of a registrant in order to register a pest control product that is equivalent to the registrant’s product, using a pest control product provided by that registrant, sections 17.5 to 17.94 do not apply if

  • (a) the registrant provides the Minister with a letter of confirmation of source; and

  • (b) the only pest control product used in the manufacture of the applicant’s product is the one provided by that registrant.

  • SOR/2010-119, s. 2

Exclusive Use

Marginal note:Exclusive use period

  •  (1) The registrant of a new active ingredient has the exclusive use of the following test data for 10 years after the date of registration:

    • (a) test data that was provided in support of the initial application to register the active ingredient;

    • (b) test data that was provided in support of a concurrent application to register a pest control product that contains that active ingredient; and

    • (c) test data that was included in any additional information that was reported to the Minister under section 12 of the Act in relation to those applications.

  • Marginal note:Exclusive use — compounds and substances

    (2) The registrant of a new pest control product described in paragraph 2(b) has the exclusive use of the test data submitted in support of the initial application to register it, for 10 years after the date of registration, if the product has never been an ingredient in a registered pest control product.

  • Marginal note:Extension — minor uses

    (3) The Minister must extend the exclusive use period in all of the following circumstances:

    • (a) the registrant

      • (i) includes minor uses in an application to register a pest control product referred to in paragraph (1)(b), or

      • (ii) on or after August 1, 2007 but in any case within seven years after the date of registration of a pest control product referred to in paragraph (1)(b), either makes an application to amend that registration to add minor uses or makes an application, that includes minor uses, to register a new pest control product that contains the same active ingredient;

    • (b) the registrant requests an extension of the period, within eight years after the date of registration; and

    • (c) the Minister determines that the proposed minor uses are minor uses, as defined in section 17.1, and approves their addition to the registration.

  • Marginal note:Calculation of extension

    (4) The following rules apply when calculating an extension:

    • (a) the exclusive use period is extended by one year for every three minor uses that are added, one or more at a time, to the registration for a maximum total period of 15 years; and

    • (b) the maximum number of minor uses in respect of a crop group is the number of representative crops in the crop group.

  • Marginal note:When minor use withdrawn or removed

    (5) Each extension of one year is cancelled if the registrant withdraws a minor use from their registration, or the Minister amends the registration and removes a minor use, such that the remaining number of minor uses is insufficient to support the extension.

  • SOR/2010-119, s. 2
  • SOR/2016-61, s. 3

Marginal note:Letter of access

 During the exclusive use period, an applicant may use or rely on test data of a registrant in an application to register a pest control product or amend a registration if the registrant provides the applicant with a letter of access.

  • SOR/2010-119, s. 2

Agreements

Marginal note:Conditions — use or reliance

  •  (1) Subject to subsection 17.94(2), an applicant may use or rely on compensable data of a registrant if they pay compensation to the registrant in accordance with an agreement for the relevant period described in subsection (2) and provide the Minister with a copy of a letter of access.

  • Marginal note:Compensable period

    (2) Compensation is payable in respect of the following compensable data that is submitted to or considered by the Minister for the first time, for the following periods:

    • (a) in the case of test data that supports an application to register a pest control product whose active ingredient is already registered, for 12 years after the date of the application;

    • (b) in the case of test data that supports an application to amend a registration, for 12 years after the date of the application;

    • (c) in the case of test data submitted in response to a notice delivered to the registrant under subsection 16(3), 18(1) or 19(1) of the Act, for 12 years after the date on which the Minister receives the data; and

    • (d) subject to subsection (3), in the case of foreign test data considered by the Minister in the course of a re-evaluation or special review, for 12 years after the date on which the Minister initiates the re-evaluation or special review.

  • Marginal note:Condition — foreign test data

    (3) Foreign test data is compensable only if the registrant is able to provide the Minister with the foreign test data on request.

  • SOR/2010-119, s. 2
 
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