Canada Gazette, Part I, Volume 156, Number 24: Regulations Amending the Pest Control Products Regulations (Protection of Test Data)

June 11, 2022

Statutory authority
Pest Control Products Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

While there are data protection provisions in the Pest Control Products Regulations (PCPR) for re-evaluation and special review (post-market review), stakeholders have indicated they are not comprehensive and clear. In addition, minor technical amendments are required to bring further clarity to the existing data protection provisions.

Background

Pest control product registration system

Pesticides are regulated in Canada by Health Canada’s Pest Management Regulatory Agency (PMRA), to ensure that they pose minimal risk to human health and the environment. The Pest Control Products Act (PCPA) governs how pesticides are regulated based on scientific risk assessment and risk management, before and after they are registered for use.

Before a pest control product can be approved for use and marketed in Canada, it must be registered or otherwise authorized under the PCPA. In order to be registered, pest control products must undergo a thorough pre-market, science-based assessment by PMRA and meet strict health and environmental standards, and must have value. If the specified uses of a pest control product pose risks of concern to human health or the environment, it is not registered for use in Canada.

Post-market reviews

Once a pest control product is registered for use in Canada, it becomes subject to a system of post-market risk management controls under the PCPA. This includes re-evaluations and special reviews (i.e. post-market reviews), compliance and enforcement activities, and reporting of health and environmental incidents.

Under the PCPA, registered pest control products are re-evaluated on a 15-year cycle to ensure that registered pesticides continue to meet current health and environmental standards and continue to have value. Unlike the cyclical re-evaluations, special reviews are with narrower scopes, and they may be triggered when the Minister has reasonable grounds to believe that health, environmental risks of the pest control product, or its value, may be unacceptable. In either a re-evaluation or special review, the Minister can decide to continue the registration as is, modify it (e.g. by establishing measures to mitigate risks), or cancel it.

Pre-market data protection program

The PCPA and the PCPR set out a data protection program for pest control products.footnote 1 During a pre-market review an applicant seeking to register a new pest control product or amend a product’s registration may choose to provide their own data to demonstrate a product’s safety and value, or they may choose to pay compensation to rely on the data of other registrants.

Data generated by pest control product registrants to support registrations in Canada receive exclusive or compensable protection status for a period of time to encourage innovation by requiring competing product manufacturers to wait and to pay compensation before gaining market access and providing timely grower access to competitively priced generic pesticides. The PCPR give 10 years of exclusive use protection to data supporting a new registration that contains an active ingredient never before registered in Canada. The exclusive use period begins at the time of registration, and registrants of pest control products under exclusive protection status can voluntarily allow other applicants (e.g. generic companies) to rely on their exclusive use data by providing them with a Letter of Access (LoA). Data is given a 12-year compensable protection status if it is used by the Minister to support the registration or amendment of a pest control product registration. This compensable data could be data used by a registrant to amend a registration or by an applicant to register a new product provided they have a LoA from the registrant who owns the data (i.e. compensation is paid). Once either the exclusive use period or the compensable period has lapsed, the data becomes generic and can be used or relied upon without consent and without the payment of compensation.

The PCPR also set out provisions for negotiation and binding arbitration to determine the amount of compensation payable for reliance on a registrant’s compensable data.footnote 2 The “Agreement for Data Protection under Section 66 of the Pest Control Products Act” is prescribed by the Minister of Health and sets out the process for determining the amount of compensation payable for the reliance on a registrant’s data, including mandatory negotiations and binding arbitration. Registrants and applicants are able to download the Agreement from the Health Canada website.

The program allows Canada to meet international commitments, including under Article 20.45 of the Canada–United States–Mexico Agreement (CUSMA), Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) set out in Annex 1C to the World Trade Organization (WTO) Agreement, and Article 20.30 of the Canada-European Union Comprehensive Economic and Trade Agreement (CETA),footnote 3 to provide protection from unfair commercial use of data.

Post-market data protection program

The Minister initiates a re-evaluation or a special review for a registered pest control product by delivering a written notice, under subsection 16(3) or 18(1) of the PCPA, to registrants explaining the reasons for the initiation (e.g. to verify the continued acceptability of a pest control product) and, if necessary, specifying the data required for such re-evaluation or special review. Under subsection 19(1) of the PCPA, additional data may be required during the re-evaluation or special review. Upon completion of a post-market review the PMRA publishes its proposed decision document followed by a final decision document.

As indicated above, the current data protection provisions of the PCPR came into force in June 2010. These provisions apply to the reliance on data for the purpose of re-evaluations and special reviews per section 17.3 of the PCPR. Specifically, section 17.3 indicates that the pre-market data protection process applies “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.” However, the lack of specific post-market provisions in the PCPR has led to questions of clarity about the processes that registrants are to follow for reliance on data during post-market reviews.

Objective

The primary objective of the proposed regulatory amendments is to clarify data protection provisions for re-evaluations and special reviews by specifying a process under which registrants who are data holders and registrants who are relying on the data of data holders could establish compensation payable, by clarifying what data is subject to compensation, and when to initiate negotiations and binding arbitration (if necessary).

Description

The following proposed amendments would be made to the PCPR:

Minor technical changes for clarification

The minor changes being proposed to the existing PCPR include updated wording to clarify the data protection provisions. For example, these amendments include changing the term “exclusive use” to “exclusive rights” and including a definition of that term to clarify its meaning. To distinguish registrants that hold data that could be compensated for from registrants who are relying on their data, a definition of “data holder” would be included. References to section 12 of the PCPA would be removed for applications received under section 7 of the PCPA as these were for conditional registrations where some of the data came in after the date of registration and PMRA no longer grants these (provisions on conditional registrations were repealed in 2017). The amendments would use the word “considers” to replace the word “used” in relation to data necessary to support a pre- or post-market registration decision as the former is more specific; this amendment would not change current practice or administration.

Other minor changes include removing references to ‘certified mail’ as the delivery requirements are set out in section 62 of the PCPA, and removing section 17.2 of the PCPR that echoes the requirement within subsection 7(2) of the PCPA that an applicant can rely on information provided by other registrants if the active ingredient of the applicant’s pest control product is equivalent to the active ingredient of a registered pest control product. As well, registrants relying on the data of others would be required to provide a LoA at the next renewal following a re-evaluation or special review decision.

Foreign test data eligibility criteria

Under the current regulations where a generic applicant wishes to rely on existing data at PMRA to support their application, and a relevant re-evaluation or special review has been completed that references a foreign regulatory authority evaluation or review, then eligible underlying data considered by the foreign regulatory authority could require compensation by the applicant. In order for a data holder to receive compensable data protection status for underlying data that support the foreign regulatory authority’s evaluation or review, the PMRA requires that the data be relevant to Canada, have never been used before, and be provided on request. These amendments would require that at the time of the generic application, the data holder would have to provide a document or a reference that indicates the data was submitted for or called in by that foreign regulatory authority and considered in the evaluation or review, and that the data must be provided to the PMRA.

Activities at the end of the re-evaluation or special review

PMRA has interpreted the current regulations as requiring the Minister to provide each registrant a list of compensable data. Under the proposed amendments, at the end of the re-evaluation or special review (i.e. when the final decision statement is made public under subsection 28(5) of the PCPA), the Minister could make available a single list of test data, instead of lists for each registrant, considered by the Minister in support of the review decision and for which compensation may be payable. This list could include data that was called in by the Minister for the re-evaluation or special review under subsections 16(3), 18(1), or 19(1) of the PCPA and data that was already on hand and relevant to a non-equivalent active ingredient if the latter was considered in a previous pre- or post-market review.

Compensability of exclusive rights data from non-equivalent active ingredients

The PCPR would be amended to allow compensation payable for exclusive rights status data relevant to non-equivalent active ingredients and relied on by a registrant in a re-evaluation or special review or by an applicant with an application to register or amend. This is being implemented further to Canada’s obligations under CETA. By contrast, data that was previously submitted to the Minister for the active ingredient under review and that is consequently on-hand for the re-evaluation or special review would continue to be considered without the requirement for compensation (as per current legislation).

Negotiation and arbitration (Agreement for data protection under section 66 of the PCPA for re-evaluations and special reviews)

Under section 66 of the PCPA, the Minister determines the terms and conditions of agreements entered into by registrants and data holders for the purposes of determining compensation. Under the proposed amendments, either the registrant wishing to rely on the data holder’s data or the data holder themselves may deliver a proposed agreement to the other party that specifies the test data that the registrant wishes to rely on. Parties would have 60 days after the final re-evaluation or special review decision is made public under subsection 28(5) of the PCPA to deliver the proposed agreement to the other party. As per current requirements, when an agreement is entered into, parties must begin to negotiate the amount of compensation payable to the data holder.

Under the proposed amendment, the negotiation period would run for 120 days after the final decision statement was made public under subsection 28(5) of the PCPA, but could be extended upon agreement between the parties. This would provide registrants flexibility to negotiate compensation at the end of the re-evaluation or special review process, if they prefer, once they know what data may be relied on. At the end of the negotiation period, if no settlement could be reached, either party may trigger binding arbitration that would last for 120 days, unless parties or the arbitrator extend.

There would be an “agreement” specifically for use in re-evaluations and special reviews called “Agreement for Data Protection under section 66 of the PCPA for Re-evaluations and Special Reviews” and a proposed agreement would be published on PMRA’s website in coordination with these proposed amendments in the Canada Gazette, Part I, for consultation.

Transitional provisions

Provisions would be included in these amendments that provide a clear transition from the current regulations to these amendments when they come into force. These amendments would generally apply to test data received in the context of any pending re-evaluation or special review where a final decision statement under subsection 28(5) of the PCPA has not yet been made public on the coming into force date. These amendments would also apply to pending applications that have not had a final decision made under subsection 8(1) of the PCPA on the coming into force date of these amendments. Additionally, any established lists of compensable data made in respect of an application, before the coming into force date would continue to be applicable under these amendments. As well, any exclusive use or compensable protection status periods that started before the coming into force date would continue under these amendments as exclusive rights or compensable protection periods, respectively.

Regulatory development

Third-party data protection program review

In 2014, PMRA requested advice from a neutral third party (Intersol) to assess whether its pesticide data protection program was achieving the right balance, thereby optimizing its impact on the competitiveness of the Canadian agricultural sector. In developing its recommendations, the third party consulted extensively with innovator companies and companies that rely on the data of data holders as well as trade associations and PMRA. The Intersol Report recommendations for the PMRA focused on the preparation of compensable data lists, the compensable status of foreign test data, guidance on the re-evaluation and special review process, conduct of the arbitration process, time limits for applicant decision making, and for the monitoring and review of the program’s performance. In 2016, the PMRA published its response to the Report, indicating that it would be developing proposed regulatory changes to clarify data protection requirements during re-evaluations and special reviews and adding criteria for the compensable status of foreign test data.footnote 4

Agri-food and Aquaculture Roadmap

During the 2018 targeted regulatory review of the agri-food and agriculture sectors, stakeholders likewise recommended that the PCPR be amended to clarify the process for data protection in the post-market context. Specifically, the Agri-food and Aquaculture Regulatory Roadmap identified that data protection requirements for pesticides are not clear enough and don’t do enough to help industry reach compensation agreements.footnote 5 Therefore, regulatory amendments relating to data protection during post-market reviews are included in the Health Canada Forward Regulatory Plan.footnote 6

Consultation

PMRA consulted pesticide industry stakeholders via a webinar in 2018 on a proposed approach for regulating data protection during post-market reviews (i.e. re-evaluations and special reviews) and to seek stakeholders’ comments on that approach. Stakeholders were provided 60 days to provide written comments on the proposal. Comments were received from six respondents, including three representing innovator registrants, two representing generic registrants, and one from the trade association CropLife Canada. There was strong support from all respondents for the general principle that registrants must generate data or commit to reliance on others’ data from the outset of the re-evaluation or special review through PMRA requiring responses to notices issued under sections 16, 18, and 19 of the PCPA. However, all respondents indicated they would require further details on the revised s. 66 Agreement, timelines, and the regulations wording to fully comment on the proposal. To address this concern, PMRA developed and distributed to stakeholders a second document outlining how the regulatory changes would interact with a new s. 66 Agreement for use in re-evaluations and special reviews and provided 30 days to provide further written comments. Note that PMRA plans to publish on the Health Canada website a proposed draft s. 66 Agreement for use in re-evaluations and special reviews during the Canada Gazette, Part I, consultation on the proposed amendments, so stakeholders can comment on both.

Instrument choice

In developing these amendments, two instrument options were considered: continue to rely on the existing s. 17.3 of the PCPR, which indicates the pre-market data protection application process applies to re-evaluations and special reviews “with any necessary modifications” or draft separate amendment provisions for re-evaluations and special reviews. The option of proceeding with amendments was selected, since it provides for a clear legal process for data protection in the post-market context, while providing clarity for regulated parties on the issues of concern to them, such as which party could trigger formal negotiation and binding arbitration process; when and how to trigger such processes; and when and how lists of data for which compensation may be payable would be made available. The amendments also allow PMRA to address the compensable status of foreign test data criteria recommended in the Intersol Report.

Stakeholders were largely in agreement with the above-mentioned design option.

Regulatory analysis

Benefits and costs

Costs to government

Costs to PMRA to implement the Regulations would be in the form of providing communications and updating guidance documents to stakeholders (applicants, registrants and data holders).

Costs to industry

Costs to industry include the costs for applicants and registrants to familiarize themselves with the amended regulations. This cost is expected to be minor as most registrants have been involved with the consultations to date.

There would be costs under some circumstances for data holders wishing to be compensated for data considered in foreign regulatory reviews, as they would need to provide additional information to the PMRA demonstrating that the data was considered by a foreign regulatory authority. This cost is not expected to be significant as these registrants already provide a cover letter for this purpose as a process requirement under the current Regulations when an application is made under section 7(2) of the PCPA and the applicant wishes to rely on a data holder’s data. Further to the proposed amendments, PMRA may require a data holder to include supporting documents with this cover letter, or add the reference source (e.g. a weblink or page number of the foreign review) to this cover letter. This additional information would assist PMRA to establish which data requires compensation, and would be included in the list of test data.

Benefits

There would be added clarity for both industry and the PMRA as the additional detail set out in the proposed amendments provides more certainty in the process for data compensation in the context of post-market reviews. As indicated in the Agri-Food and Aquaculture Roadmap, this would help registrants reach compensation agreements in a more timely manner. PMRA could benefit from reduced costs, as it may decide to no longer review, compile and send a compensable data list to each registrant for each review. Instead, there could be one list per review made available at the time of the final re-evaluation or special review decision. Likewise, industry could benefit from having one list to refer to rather than having to seek and review multiple lists.

There would be a benefit to data holders who would be compensated for exclusive rights status data considered in pre- and post-market registration decisions involving non-equivalent active ingredients. Registrants and applicants choosing to rely on the data of data holders with exclusive rights from a non-equivalent active ingredient would have to pay compensation to the data holder. However, this will benefit the registrants choosing to rely on this data as they would not have to provide their own data allowing for more options to keep their products on the market.

Clarifying that either party could trigger a negotiation or arbitration following a re-evaluation or special review would likewise clarify the process and help registrants to enter into these processes in a predicable and timely manner.

Small business lens

Most major pest control product registrants (data holders) are multinationals with subsidiary offices representing them in Canada. However, PMRA estimates that most registrants are small businesses under the definition of having fewer than 100 employees. Small businesses are expected to have the same costs and benefits as described above as these amendments would apply to small, medium and large businesses equally. Small businesses are expected to benefit from being allowed to rely on data in more situations, such as exclusive rights status data considered for re-evaluation or special review registration decisions involving non-equivalent active ingredients, instead of either providing their own data or having to leave the market. At the same time, data holders are expected to benefit because if their exclusive rights status data is considered in such situations they would have the opportunity to be paid compensation.

Small businesses would be required to incur incremental compliance costs to learn the new processes; however, these are expected to be low. Most registrants, including those that are small businesses, are expected to be familiar with the existing requirement and have been actively involved in consultations. They would also see more certainty in the process, which would provide clearer options for how to keep their products on the Canadian market.

These amendments are intended to improve conditions for a market with clear rules, in support of fair transactions for data used in support of for re-evaluations and special reviews. Market transactions will take place under conditions where an exchange is favourable to both parties; as such, no flexibility specifically for small businesses were considered.

One-for-one rule

The one-for-one rule applies since there would be an incremental increase in administrative burden on business, and the proposal is considered burden in under the rule. This increase in administrative burden has been estimated at an annualized cost of $7 as calculated in accordance with the Red Tape Reduction Regulations (2012 price levels and discounted to 2012 at a discount rate of 7%).

This administrative burden increase is associated with requirements to receive compensable data protection status for underlying data that support the foreign regulatory authority’s evaluation or review. To be eligible, at the time of a generic application, the data holder would have to provide a document or a reference that indicates the data was submitted for or called in by that foreign regulatory authority and considered in the evaluation or review. PMRA has observed over the last three years only one registration using data from a foreign review. In order to not underestimate this cost, it has been assumed that this may occur up to once every two years, or a frequency of 0.5 per year. It has been assumed that a data holder would require at most one hour to provide evidence (documentation, links to references) to support compensable data protection, and this task would be performed by the national occupational code for administrative occupations at a cost of labour of nearly $30 an hour (2012 CAD including overhead costs).

Regulatory cooperation and alignment

These proposed amendments are modelled, in part, on the United States Environmental Protection Agency (U.S. EPA) system, and are consistent with CUSMA, CETA and TRIPS, which require protection of pest control product regulatory test data from unfair commercial use.

As well, on September 21, 2017, the PCPA and the PCPR amendments came into force regarding protecting test data across non-equivalent active ingredients to implement CETA. As noted above, aspects of the proposed amendments help to fulfil obligations under CETA.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for this amendment.

Implementation, compliance and enforcement, and service standards

Implementation

To provide registrants and applicants with time to adjust to the amendments, Health Canada is proposing a delayed coming into force as part of the implementation. The proposed amendments would come into force six months after the day on which they are published in the Canada Gazette, Part II.

The regulatory amendments associated with this proposal may result in changes to related policies and interpretive guidance. Consistent with Health Canada’s obligations under the PCPA, consultation on those changes to policies and guidance would take place as required.

Compliance and enforcement

Health Canada encourages, promotes, maintains and enforces compliance with the PCPA through active prevention; inspections, including surveillance; and enforcement response actions. Active prevention aims to educate, facilitate and promote compliance as well as to communicate regulatory information. Inspections are designed to determine the level of compliance of users, distributors and registrants of pesticides with the general provisions of the PCPA and its regulations, as well as specific terms and conditions of registration.

Enforcement response may include warning letters; detention, seizure and forfeiture of products; compliance orders under the PCPA; and notices of violation with warning or monetary penalty under the Agriculture and Agri-Food Administrative Monetary Penalties Act.

Compliance with the PCPA and its regulations is achieved through a network of officers and inspectors across Canada. Health Canada regional offices also have formal agreements with provincial pesticide regulatory departments, providing a basis to collaborate with them in inspections and in the development and delivery of compliance activities.

Health Canada follows an established compliance and enforcement policy to promote and enhance fair treatment of the regulated community.

Service standards

PMRA follows established service standards, or defined timelines, for evaluating new or amended registrations as outlined in PMRA’s Management of Submissions Policy.footnote 7

Contact

Jordan Hancey
Policy and Operations Directorate
Pest Management Regulatory Agency
Health Canada
2720 Riverside Drive
Ottawa, Ontario
K1A 0K9
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to section 67footnote a of the Pest Control Products Act footnote b, proposes to make the annexed Regulations Amending the Pest Control Products Regulations (Protection of Test Data).

Interested persons may make representations concerning the proposed draft regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Jordan Hancey, Director, Policy and Regulatory Affairs Division, Policy and Operations Directorate, Pest Management Regulatory Agency, Department of Health, Mail Stop: 6607, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9 (email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca).

Ottawa, June 6, 2022

Wendy Nixon
Assistant Clerk of the Privy Council

Regulations Amending the Pest Control Products Regulations (Protection of Test Data)

Amendments

1 (1) Subsection 16(2) of the Pest Control Products Regulations footnote 8 is amended by striking out “and” at the end of paragraph (c) and by replacing paragraph (d) with the following:

(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.

2 The heading “Interpretation” before section 17.1 of the English version of the Regulations is replaced by the following:

Definitions

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
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 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)

4 The heading before section 17.2 of the French version of the Regulations is replaced by the following:

Application

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

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:

Calculation of extension

(3) The Minister must apply the following rules when calculating an extension:

When minor use removed

(4) The Minister must cancel any extension of one year if

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:

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:

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 an agreement with the applicant specifying the test data that the applicant wishes to use or rely on.

Negotiation of compensation payable and settlement

17.08 (1) When an 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

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

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:

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):

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:

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 a registrant, 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 the registrant 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 who receives the proposed agreement must enter into an agreement with the other party specifying the test data that the registrant wishes to use or rely on.

Negotiation of compensation payable and settlement

17.15 (1) When an 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

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

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.

6 (1) Paragraph 38(3)(b) of the Regulations is replaced by the following:

(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.

Transitional Provisions

7 The following definitions apply in this section and in sections 8 to 12:

Act
means the Pest Control Products Act. (Loi)
commencement day
means the day on which these Regulations come into force. (date d’entrée en vigueur)
former Regulations
means the Pest Control Products Regulations as they read immediately before the commencement day. (règlement antérieur)
new Regulations
means the Pest Control Products Regulations as they read on the commencement day. (nouveau règlement)

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.

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.

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:

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:

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:

Coming into Force

13 These Regulations come into force on the 180th day after the day on which they are published in the Canada Gazette, Part II.