Pest Control Products Regulations (SOR/2006-124)
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Regulations are current to 2023-09-19 and last amended on 2023-06-05. Previous Versions
AMENDMENTS NOT IN FORCE
— SOR/2023-104, s. 1
1 (1) Subsection 16(2) of the Pest Control Products RegulationsFootnote 1 is amended by striking out “and” at the end of paragraph (c) and by replacing paragraph (d) with the following:
Return to footnote 1SOR/2006-124
(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.
(2) Section 16 of the Regulations is amended by adding the following after subsection (2):
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.
— SOR/2023-104, s. 2
2 The heading “Interpretation” before section 17.1 of the English version of the Regulations is replaced by the following:
Definitions
— SOR/2023-104, s. 3
3 Section 17.1 of the Regulations is replaced by the following:
Definitions
17.01 The following definitions apply in this section and sections 17.02 to 17.17.
- agreement
agreement means an agreement referred to in subsection 66(1) of the Act. (entente)
- compensable data
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
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
data holder means a registrant to whom compensation may be payable in respect of test data. (détenteur de données)
- exclusive rights
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
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
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 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/2023-104, s. 4
4 The heading before section 17.2 of the French version of the Regulations is replaced by the following:
Application
— SOR/2023-104, s. 5
5 Sections 17.2 to 17.94 of the Regulations are replaced by the following:
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.
Exclusive Rights
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.
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.
Compensation Payable
Registration
Conditions — use of or reliance on test data
17.05 (1) Subject to subsection 17.1(2), an applicant who makes an application to register a pest control product or to amend a registration may, in accordance with the agreement concluded with the data holder under subsection 17.07(2), use or rely on the following test data if they pay compensation to the data holder in accordance with the negotiated settlement or arbitral award for the period provided for in subsection (2) and if the applicant provides the Minister with a copy of a letter of access:
(a) compensable data that the applicant wishes to use or rely on;
(b) test data for which the data holder has exclusive rights, if the test data is relevant to the pest control product of the data holder and the test data is relevant to an active ingredient that is not equivalent to the active ingredient contained in the applicant’s pest control product; and
(c) test data that was considered during an evaluation or review of a pest control product by a foreign regulatory authority and that the data holder has not previously provided to the Minister, if the following conditions are met:
(i) the Minister has considered for the first time the decision that results from the evaluation or review of the pest control product by the foreign regulatory authority in support of the re-evaluation or special review decision of the data holder’s pest control product,
(ii) the Minister requests that the data holder provide the Minister with the following in the form and manner directed by the Minister:
(A) documents demonstrating that the test data was provided to the foreign regulatory authority in support of the evaluation or review of the pest control product, or in response to a request from the foreign regulatory authority relating to the evaluation or review,
(B) documents demonstrating that the foreign regulatory authority considered the test data in support of its decision of the evaluation or review, and
(C) the test data, and
(iii) the data holder complies with the request.
Compensable period
(2) The period for which compensation is payable by the applicant to the data holder commences on one of the following days and must not exceed 12 years, except in the case of the test data referred to in paragraph (d) for which the period must not exceed the period set out in section 17.03:
(a) in the case of compensable data in support of an application to register a pest control product of the data holder, the day on which the Minister receives the application;
(b) in the case of compensable data in support of an application to amend the registration of a pest control product of the data holder, the day on which the Minister receives the application;
(c) in the case of compensable data that is considered by the Minister during a re-evaluation or special review of a pest control product of the data holder, if the test data was provided by the data holder 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, the day on which the Minister receives the data;
(d) in the case of test data referred to in paragraph (1)(b), the day of registration referred to in subsection 17.03(1); or
(e) in the case of test data referred to in paragraph (1)(c), the day on which the Minister initiates the re-evaluation or special review.
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.
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.
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.
Arbitration
17.09 (1) Despite subsection 17.08(2), in the absence of a negotiated settlement at the end of the negotiation and in accordance with the agreement entered into by the parties, the applicant may, by delivering to the data holder a written notice, submit the determination of the compensation payable to binding arbitration.
Notice
(2) The notice must contain the last offers of the applicant and the data holder, if they were presented in writing at the end of the negotiation.
Arbitral award
(3) The arbitrator must make an arbitral award within 120 days after the day on which the notice is delivered, unless
(a) the parties agree to an extension before the end of that period and provide written notice to the arbitrator; or
(b) the arbitrator provides written notice of an extension to the parties before the end of that period.
Letter of access
17.1 (1) When a negotiated settlement is reached or an arbitral award is made, the data holder must provide the applicant with a letter of access, signed by the data holder, confirming that the applicant may use or rely on their test data.
Failure to provide letter of access
(2) If the data holder fails to provide the letter of access within the period specified in the negotiated settlement or arbitral award, the applicant may use or rely on the test data without having to continue to comply with the settlement or award.
Early registration
17.11 (1) The applicant may, as soon as a notice referred to in subsection 17.09(1) has been delivered to the data holder, request that the Minister register their pest control product before obtaining a letter of access and may use or rely on the test data of the data holder if all of the following conditions are met:
(a) the applicant enters into an escrow agreement with a third party;
(b) the third party is entitled under the laws of a province to receive and hold an amount of money on behalf of another person;
(c) under the escrow agreement, the applicant deposits with the third party an amount of money equal to the data holder’s last offer referred to in subsection 17.09(2);
(d) the escrow agreement contains all of the following terms:
(i) the third party holds the money until it becomes payable in accordance with the escrow agreement,
(ii) on receipt of a copy of the registration certificate, the third party pays the data holder an amount of money equal to the applicant’s last offer referred to in subsection 17.09(2),
(iii) on receipt of a copy of the negotiated settlement or arbitral award, the third party pays the data holder the compensation payable as determined in the settlement or award, less the amount paid under subparagraph (ii),
(iv) the third party pays any remaining balance to the applicant.
Copy and proof to Minister
(2) The applicant must send the Minister both a copy of the escrow agreement and proof that the applicant has deposited the money in accordance with paragraph (1)(c).
When no last offer in writing
(3) If the data holder’s last offer was not made in writing at the end of the negotiation, the conditions set out in subsection (1) and subsection (2) do not apply.
Re-evaluation and Special Review
Conditions — use of or reliance on test data
17.12 (1) Subject to subsection 17.17(2), in the context of a re-evaluation or special review and on receipt of 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, a registrant may, in accordance with the agreement concluded with the data holder under subsection 17.14(2), use or rely on the following test data if they pay compensation to the data holder in accordance with the negotiated settlement or arbitral award for the period set out in subsection (2):
(a) compensable data that the registrant wishes to use or rely on that is
(i) provided to the Minister, in the context of the re-evaluation or special review, by the data holder in response to a notice initiating the process under subsection 16(3) or 18(1) of the Act or to a notice requiring additional information under paragraph 19(1)(a) of the Act, and
(ii) relevant to the pest control product that is the subject of the re-evaluation or special review; and
(b) test data that the Minister considers in support of the re-evaluation or special review decision in respect of the pest control product but that was not provided in response to one of the notices referred to in paragraph (a) and that is relevant to an active ingredient that is not equivalent to the active ingredient contained in the pest control product that is the subject of the re-evaluation or special review if
(i) the test data is already compensable data, or
(ii) the data holder already has exclusive rights in respect of the test data.
Compensable period
(2) The period for which compensation is payable for the following test data by the registrant to the data holder commences on one of the following days and must not exceed 12 years, except in the case of the test data referred to in subparagraph (b)(ii) for which the period must not exceed the period provided for in section 17.03:
(a) in the case of compensable data provided by the data holder under paragraph (1)(a), the day on which the Minister receives the data; or
(b) in the case of test data referred to in paragraph (1)(b),
(i) if the data is already compensable data, one of the days referred to in paragraph 17.05(2)(a), (b), (c) or (e), as the case may be, or
(ii) if the data holder already has exclusive rights in respect of the data, the day of registration referred to in subsection 17.03(1).
Minister to identify test data
17.13 For the purposes of subsections 16(5) and (5.1) and 18(3) and (3.1) of the Act, the Minister must make available to data holders and other registrants, on the day on which the Minister makes public the decision statement referred to in subsection 28(5) of the Act, a list of the test data referred to in subsection 17.12(1) in respect of which compensation may be payable by any of those registrants and in respect of which an agreement is required to be entered into between the registrant and each data holder whose data the registrant wishes to use or rely on.
Proposed agreement on test data
17.14 (1) Either the registrant or the data holder may deliver to the other party a proposed agreement that specifies the test data that the registrant wishes to use or rely on no later than 60 days after the day on which the decision statement referred to in subsection 28(5) of the Act is made public.
Agreement entered into
(2) The registrant or the data holder must, on receipt of the proposed agreement from the other party, enter into the agreement with the other party.
Negotiation of compensation payable and settlement
17.15 (1) When the agreement is entered into, a registrant 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 registrant wishes to use or rely on.
Period of negotiation and settlement
(2) The registrant 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 decision statement referred to in subsection 28(5) of the Act is made public; or
(b) by the end of any additional negotiation period, if the parties agree in writing to continue negotiating.
Arbitration
17.16 (1) Despite subsection 17.15(2), in the absence of a negotiated settlement at the end of the negotiation and in accordance with the agreement entered into by the parties, the registrant or the data holder may, by delivering to the other party a written notice, submit the determination of the compensation payable to binding arbitration.
Notice
(2) The notice must contain the last offers of the registrant and the data holder, if they were presented in writing at the end of the negotiation.
Arbitral award
(3) The arbitrator must make an arbitral award within 120 days after the day on which the notice is delivered, unless
(a) the parties agree to an extension before the end of that period and provide written notice to the arbitrator; or
(b) the arbitrator provides written notice of an extension to the parties before the end of that period.
Letter of access
17.17 (1) When a negotiated settlement is reached or an arbitral award is made, the data holder must provide the registrant with a letter of access, signed by the data holder, confirming that the registrant may use or rely on their test data.
Failure to provide letter of access
(2) If the data holder fails to provide the letter of access within the period specified in the negotiated settlement or arbitral award, the registrant may use or rely on the test data without having to continue to comply with the settlement or award.
— SOR/2023-104, s. 6
6 (1) Paragraph 38(3)(b) of the Regulations is replaced by the following:
(b) the test data referred to in paragraphs (a) and (b) of the definition exclusive rights in section 17.01 that were provided in support of its registration are no longer subject to exclusive rights within the meaning of that definition.
(2) Section 38 of the Regulations is amended by adding the following after subsection (3):
Interpretation — test data
(3.1) In subsection (3), test data has the same meaning as in section 17.01.
— SOR/2023-104, s. 7
7 The following definitions apply in this section and in sections 8 to 12:
- Act
Act means the Pest Control Products Act. (Loi)
- commencement day
commencement day means the day on which these Regulations come into force. (date d’entrée en vigueur)
- former Regulations
former Regulations means the Pest Control Products Regulations as they read immediately before the commencement day. (règlement antérieur)
- new Regulations
new Regulations means the Pest Control Products Regulations as they read on the commencement day. (nouveau règlement)
— SOR/2023-104, s. 8
8 (1) The new Regulations apply in respect of an application to register a pest control product or to amend a registration if a decision under subsection 8(1) of the Act in respect of the application is pending on the commencement day.
(2) Despite section 17.06 of the new Regulations, the Minister is not required to provide a new list in respect of an application referred to in subsection (1) if the Minister provided a list in respect of the application under subsection 17.8(1) of the former Regulations.
— SOR/2023-104, s. 9
9 If a portion of a period of exclusive use referred to in section 17.5 of the former Regulations remains on the commencement day, the portion is deemed to be the remaining portion of a period of exclusive rights as defined in section 17.01 of the new Regulations.
— SOR/2023-104, s. 10
10 In the context of a re-evaluation or special review of a pest control product, the new Regulations apply in respect of test data received by the Minister in response to one of the following notices that was delivered on or after June 3, 2010 and before the commencement day, if the Minister has not made public a decision statement in respect of the re-evaluation or special review under subsection 28(5) of the Act before the commencement day:
(a) a notice initiating the re-evaluation or special review under subsection 16(3) or 18(1) of the Act; or
(b) if the re-evaluation or special review commenced on or after June 28, 2006, a notice requiring additional information under paragraph 19(1)(a) of the Act.
— SOR/2023-104, s. 11
11 In the context of a re-evaluation or special review of a pest control product, the former Regulations apply in respect of test data received by the Minister in response to one of the following notices that was delivered on or after June 3, 2010 and before the commencement day, if the Minister has made public a decision statement in respect of the re-evaluation or special review under subsection 28(5) of the Act before the commencement day:
(a) a notice initiating the re-evaluation or special review under subsection 16(3) or 18(1) of the Act or a notice initiating any previous re-evaluation or special review under those provisions; or
(b) if the re-evaluation or special review or any previous re-evaluation or special review commenced on or after June 28, 2006, a notice requiring additional information under paragraph 19(1)(a) of the Act.
— SOR/2023-104, s. 12
12 In the context of a re-evaluation or special review of a pest control product, the former Regulations apply in respect of test data provided in support of an application by another registrant under subsection 7(1) of the Act to register another pest control product or to amend its registration if the following conditions are met:
(a) the active ingredient contained in the pest control product that is the subject of the re-evaluation or special review is not equivalent to the active ingredient contained in the other pest control product;
(b) the re-evaluation or special review commenced on or after June 28, 2006;
(c) the application was made on or after June 3, 2010; and
(d) the Minister has made public a decision statement in respect of the re-evaluation or special review under subsection 28(5) of the Act on or after September 21, 2017 but before the commencement date.
- Date modified: