Pest Control Products Regulations (SOR/2006-124)

Application for Registration

Marginal note:Contents

• 6 (1) An application to register or amend the registration of a pest control product must include all of the following information:

  • (a) the applicant’s name, address and signature or, if the application is made by a representative of the applicant, both the representative’s and applicant’s name and address and the representative’s signature;

  • (b) the name and address of

    • (i) each place of manufacture of the pest control product, if it is or contains a microbial agent, and

    • (ii) each place of production and formulation of the pest control product, in any other case;

  • (c) the product name referred to in paragraph 26(1)(a);

  • (d) the product type referred to in paragraph 26(1)(b);

  • (e) the product’s physical form referred to in paragraph 26(1)(c);

  • (f) the registration number referred to in paragraph 26(1)(i), if there is one;

  • (g) in the case of

    • (i) a chemical pest control product that is an active ingredient, its chemical name, common chemical name and CAS registry number, its percentage of the total weight of the product in which it is contained, the name of each contaminant and other impurity that it contains, and the percentage of total weight of each contaminant and impurity,

    • (ii) a chemical pest control product other than an active ingredient, the chemical name, common chemical name and CAS registry number of each active ingredient in the product, each active ingredient’s percentage of the total weight of the product, and the registration number of each active ingredient or other pest control product used to manufacture the product, and

    • (iii) any other pest control product, any characteristics that are relevant to its health or environmental risks or value;

  • (h) in the case of a pest control product that contains one or more formulants, the name of each formulant, its CAS registry number if any, its percentage of the total weight of the product and its purpose in the product;

  • (i) the size, type and specifications of the package in which the pest control product is to be distributed; and

  • (j) the statement described in paragraph 26(1)(h).

• Marginal note:Electronic copy of label

  (2) The applicant must include an electronic copy of the proposed label with every application to register a pest control product and with any application to amend the registration of a pest control product that would result in a change to the label.

• Marginal note:Certification

  (3) The applicant must include with every application to register or amend the registration of a pest control product a statement signed by the applicant certifying that the information in the application is accurate and complete.

Marginal note:Records

• 7 (1) An applicant referred to in subsection 6(1) or a registrant referred to in subsection 16(1) must keep records of

  • (a) in the case of a pest control product other than one that is or contains a microbial agent, the address of each place of manufacture of a pest control product, other than a place of production or formulation; and

  • (b) in the case of a pest control product that contains one or more formulants, the name and address of the supplier of each formulant.

• Marginal note:Retention

  (2) The applicant or the registrant must keep the records for five years after, as the case may be, the date of registration, its amendment or its renewal.

• Marginal note:Change of information

  (3) If the information contained in the records changes, the applicant or registrant must update it but the previous records must be kept for five years after the day on which the update occurs.

• Marginal note:Production of records

  (4) On request by the Minister, an inspector or an analyst, the applicant or registrant must provide any records to the Minister, the inspector or the analyst within the period specified in the request.

Marginal note:Additional information required

8 In addition to the information required by section 6, the applicant must provide the Minister with any other information that the Minister may require to evaluate the health and environmental risks and the value of the pest control product, including, if relevant to the product and its conditions or proposed conditions of registration, the results of scientific investigations respecting any of the following:

• (a) the efficacy of the pest control product for its intended purpose;

• (b) the risks posed by the pest control product and its derivatives to humans or animals that may be exposed to it, including when it is manufactured, handled, stored, transported or distributed or during or after its use or disposal, in accordance with its conditions or proposed conditions of registration;

• (c) the effect of the pest control product and its derivatives on host organisms in connection with which it is intended to be used;

• (d) the effect of the pest control product and its derivatives on representative species of organisms not targeted by its intended use;

• (e) the degree of persistence, retention and movement of the pest control product and its derivatives in the environment, including the degree to which the pest control product and its derivatives may leach or dislodge from things treated with the product;

• (f) methods of analysis for detecting the components and measuring the characteristics of the pest control product;

• (g) methods of analysis for detecting and determining the amount of the pest control product and its derivatives in human food, animal feed and the environment when the product is used in accordance with its conditions or proposed conditions of registration;

• (h) appropriate methods for detoxifying or neutralizing the pest control product in water, air or soil, or on any surface;

• (i) appropriate methods for disposing of the pest control product and its empty packages;

• (j) the stability of the pest control product under normal conditions of storage and display;

• (k) the compatibility of the pest control product with other pest control products with which it is recommended to be, or is likely to be, mixed;

• (l) the effect of mixing the pest control product or using it simultaneously with other pest control products on its value and the health and environmental risks associated with its use;

• (m) the chemical and physical properties, or the species or strain and biological properties, of the pest control product, its composition, and specifications and processes for its manufacture, including quality control processes;

• (n) the fate of the pest control product in humans or animals exposed to it, including the identity and quantity of all the major metabolites and other derivatives that result from its use;

• (o) the residues of the pest control product and its derivatives that may remain in or on human food or animal feed after its use in accordance with its conditions or proposed conditions of registration;

• (p) the risks posed to humans or animals exposed to the pest control product or its derivatives through their diet or drinking water when the product is used in accordance with its conditions or proposed conditions of registration;

• (q) the effect of storing and processing, including post-market processing, human food or animal feed in relation to which the pest control product was used on the dissipation or degradation of the pest control product and any of its derivatives;

• (r) the proposed maximum residue limits for the pest control product and its derivatives in or on human food; and

• (s) the fate of the pest control product and its derivatives in subsequent crops of human food or animal feed.

Marginal note:Additional information — affidavit and contents

• 9 (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.

Marginal note:Reference in Register

10 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

11 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

12 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

13 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.

14 [Repealed, SOR/2017-91, s. 4]

15 [Repealed, SOR/2017-91, s. 4]

Renewal of Registration

Marginal note:Five-year periods

• 16 (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.

Re-evaluations and Special Reviews

Marginal note:Additional information — affidavit and contents

• 17 (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.

Protection of Test Data

Interpretation

Marginal note:Definitions

17.1 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)