GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Pest Control Products Regulations — 5.1
Electronic delivery 5.1 (1) For the purpose of subsection 62(1) of the Act, notices or other documents required or authorized to be delivered under the Act may be delivered electronically through the website of the Government of Canada or by another means of electronic communication. Deemed time of delivery (2) A notice or other document that is delivered electronically is considered to have been delivered (a) if it was delivered through that website, on the earlier of (i) the date of its delivery as indicated through that website, and (ii) the date of its delivery as indicated by a means of automatic electronic communication generated by that website; and (b) if it was delivered using another means of electronic communication, on the date that is indicated as the day of its delivery by the other means. Setting aside deemed time of delivery (3) A deemed time of delivery of a notice or other document may be set aside on the basis of any metadata or data from any other tracking system that relates to the notice or other document. SOR/2022-241, s. 5
Pest Control Products Regulations — 6
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). 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. 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. SOR/2014-24, s. 4; SOR/2016-61, s. 1(F); SOR/2017-91, s. 2 SOR/2022-241, s. 6
Pest Control Products Regulations — 7
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. 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. 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. 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. SOR/2022-241, s. 7
Pest Control Products Regulations — 7.1
Stockholm Convention — evaluations not necessary 7.1 (1) No evaluation under paragraph 7(3)(a) of the Act is necessary when (a) the application is to register or amend the registration of a pest control product that is or contains an active ingredient that is listed as a chemical in Annex A (Elimination) or Annex B (Restriction) of the Stockholm Convention; (b) the application pertains to a production or use of the active ingredient that is prohibited under the Convention; (c) the amendment to the Convention that resulted in the listing has been ratified by Canada by the deposit of its instrument of ratification with the Secretary-General of the United Nations acting as the Depository of the Convention; and (d) the proposed production or use of the active ingredient in the application: (i) is not subject to a specific exemption, or acceptable purpose, notified by Canada under the Convention, as set out in the Register of Specific Exemptions, or a Register of Acceptable Purposes, established under that Convention, or (ii) is not otherwise permitted under the Convention. Denial of application (2) For the purpose of subsection 8(4) of the Act, the health or environmental risks of a pest control product described in subsection (1) are not acceptable. SOR/2022-241, s. 8
Pest Control Products Regulations — 9
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. 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. 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
Pest Control Products Regulations — 10
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.
Pest Control Products Regulations — 11
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.
Pest Control Products Regulations — 12
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.
Pest Control Products Regulations — 13
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. SOR/2017-91, s. 3
Pest Control Products Regulations — 16
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. 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; (d) if sections 17.05 to 17.11 apply, whichever of the following documents is applicable: (i) a document that establishes that, as of the date the application is made, a negotiated settlement between the registrant and the data holder has been reached or an arbitral award has been made in respect of the test data and the data holder has not provided a letter of access referred to in section 17.1 to the registrant, or (ii) a copy of the letter of access referred to in section 17.1; and (e) if sections 17.12 to 17.17 apply, whichever of the following documents is applicable: (i) a document that establishes that, as of the date the application is made, (A) the registrant and data holder are negotiating the compensation payable in respect of the test data, (B) the determination of the compensation payable in respect of the test data has been submitted to binding arbitration and an arbitral award has not been made, or (C) a negotiated settlement between the registrant and the data holder has been reached or an arbitral award has been made in respect of the test data and the data holder has not provided a letter of access referred to in section 17.17 to the registrant, or (ii) a copy of the letter of access referred to in section 17.17. Interpretation — data holder and test data (2.1) In subsection (2), data holder and test data have the same meanings as in section 17.01. 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 SOR/2023-104, s. 1
Pest Control Products Regulations — 17
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. 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. 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
Pest Control Products Regulations — 17.01
Definitions 17.01 The following definitions apply in this section and sections 17.02 to 17.17. agreement means an agreement referred to in subsection 66(1) of the Act. ( entente ) compensable data means test data that the Minister considers for the first time in support of a registration, confirmation of the registration or amendment of the registration, but does not include (a) test data that is referred to in the definition exclusive rights ; (b) test data that is included in a scientific study that has been published; or (c) test data that is generated by a scientific study that is fully funded by a government or one of its institutions. ( données assujetties à des droits à payer ) 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 ) data holder means a registrant to whom compensation may be payable in respect of test data. ( détenteur de données ) exclusive rights means the exclusive rights to use or rely on any of the following test data that the Minister considers for the first time in support of a registration: (a) test data that the applicant provides in support of an application to register a new active ingredient; (b) test data that the applicant provides in support of a concurrent application to register a new pest control product that contains the new active ingredient referred to in paragraph (a); or (c) test data that the applicant provides in support of an application to register a new compound or substance referred to in paragraph 2(b), if the compound or substance has never been an ingredient in a registered pest control product. ( droits exclusifs ) 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) the use is supported by a federal or provincial agricultural authority; (c) the use is supported by crop residue data or dislodgeable foliar residue data. ( usage limité ) 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 means test data that is provided to the Minister (a) in support of an application to register a pest control product or to amend a registration made under section 7 of the Act, or (b) in the context of a re-evaluation or special review, in response to a notice initiating the process under subsection 16(3) or 18(1) of the Act or a notice requiring additional information under paragraph 19(1)(a) of the Act. ( données d’essai ) SOR/2010-119, s. 2; SOR/2017-169, s. 1 SOR/2023-104, art. 3
Pest Control Products Regulations — Pest Control Products Regulations
agreement means an agreement referred to in subsection 66(1) of the Act. ( entente )
Pest Control Products Regulations — (a)
compensable data means test data that the Minister considers for the first time in support of a registration, confirmation of the registration or amendment of the registration, but does not include (a) test data that is referred to in the definition exclusive rights ; (b) test data that is included in a scientific study that has been published; or (c) test data that is generated by a scientific study that is fully funded by a government or one of its institutions. ( données assujetties à des droits à payer )
Pest Control Products Regulations — Pest Control Products Regulations
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 )
Pest Control Products Regulations — Pest Control Products Regulations
data holder means a registrant to whom compensation may be payable in respect of test data. ( détenteur de données )
Pest Control Products Regulations — (a)
exclusive rights means the exclusive rights to use or rely on any of the following test data that the Minister considers for the first time in support of a registration: (a) test data that the applicant provides in support of an application to register a new active ingredient; (b) test data that the applicant provides in support of a concurrent application to register a new pest control product that contains the new active ingredient referred to in paragraph (a); or (c) test data that the applicant provides in support of an application to register a new compound or substance referred to in paragraph 2(b), if the compound or substance has never been an ingredient in a registered pest control product. ( droits exclusifs )
Pest Control Products Regulations — (a)
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) the use is supported by a federal or provincial agricultural authority; (c) the use is supported by crop residue data or dislodgeable foliar residue data. ( usage limité )
Pest Control Products Regulations — Pest Control Products Regulations
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 )
Pest Control Products Regulations — (a)
test data means test data that is provided to the Minister (a) in support of an application to register a pest control product or to amend a registration made under section 7 of the Act, or (b) in the context of a re-evaluation or special review, in response to a notice initiating the process under subsection 16(3) or 18(1) of the Act or a notice requiring additional information under paragraph 19(1)(a) of the Act. ( données d’essai )
Pest Control Products Regulations — 17.02
Non-application — product copies 17.02 When an applicant wishes to use or rely on the test data of a registrant in order to register a pest control product that is equivalent to the registrant’s product by using an active ingredient provided by the registrant, sections 17.03 to 17.11 do not apply if (a) the registrant provides the Minister with a letter, signed by the registrant, that specifies the active ingredient that they agree to provide to the applicant; and (b) the only active ingredient used in the manufacture of the applicant’s pest control product is the one provided by the registrant. SOR/2023-104, s. 5
Pest Control Products Regulations — 17.03
Period — general 17.03 (1) A registrant has exclusive rights for 10 years after the date of registration of the new active ingredient, of the new pest control product that contains the new active ingredient or of the new compound or substance. Extension — minor uses (2) The Minister must extend the period of exclusive rights if all of the following conditions are met: (a) the registrant meets one of the following requirements: (i) they proposed a minor use in the concurrent application to register a new pest control product referred to in paragraph (b) of the definition exclusive rights in section 17.01, or (ii) they made one of the following applications within seven years after the date of registration of the product referred to in subparagraph (i): (A) an application to amend its registration by adding a minor use, or (B) an application to register another new pest control product that contains the same active ingredient as the product and in respect of which a minor use is proposed; (b) the registrant requests an extension of the period of exclusive rights, within eight years after the date of registration of the new active ingredient referred to in paragraph (a) of the definition exclusive rights in section 17.01; (c) the Minister determines that the proposed minor use is a minor use and approves its addition to the registration of the product referred to in subparagraph (a)(i) or the other new pest control product referred to in clause (a)(ii)(B). Calculation of extension (3) The Minister must apply the following rules when calculating an extension: (a) the period of exclusive rights is extended by one year for every three minor uses that are added, whether one or more at a time, to the registration for a total period of exclusive rights 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. When minor use removed (4) The Minister must cancel any extension of one year if (a) the Minister, on his or her own initiative or in response to a request from the registrant, amends the registration and removes one or more minor uses; and (b) the remaining number of minor uses is insufficient to uphold the extension. SOR/2023-104, s. 5
Pest Control Products Regulations — 17.04
Consent 17.04 Subject to paragraph 17.05(1)(b), during the period of exclusive rights an applicant may use or rely on a registrant’s test data in an application to register a pest control product or amend a registration if the registrant provides the applicant with written consent to use or rely on the test data. SOR/2023-104, s. 5
Pest Control Products Regulations — 17.06
Minister to identify test data 17.06 For the purpose of subsection 7(2) of the Act, the Minister must provide the applicant with a list of the test data referred to in subsection 17.05(1) for which compensation may be payable by the applicant and in respect of which an agreement is required to be entered into between the applicant and each data holder whose data the applicant wishes to use or rely on. SOR/2023-104, s. 5
Pest Control Products Regulations — 17.07
Proposed agreement on test data 17.07 (1) On receipt of the list of test data, an applicant may deliver to each data holder a proposed agreement that specifies the test data that the applicant wishes to use or rely on. Agreement entered into (2) On receipt of the proposed agreement, the data holder must enter into the agreement with the applicant. SOR/2023-104, s. 5
Pest Control Products Regulations — 17.08
Negotiation of compensation payable and settlement 17.08 (1) When the agreement is entered into, an applicant and a data holder must, in order to reach a settlement, begin to negotiate the compensation payable in respect of the test data that the applicant wishes to use or rely on. Period of negotiation and settlement of compensation payable (2) The applicant and the data holder must reach a negotiated settlement in respect of the compensation payable (a) within 120 days after the day on which the data holder receives the proposed agreement; or (b) by the end of any additional negotiation period, if the parties agree in writing to continue negotiating. SOR/2023-104, s. 5