Consultation Summary: Consultation on Inspecting Confidential Test Data for Post-market Reviews in the Reading Room, Discussion Document DIS2019-01

Pest Management Regulatory Agency
31 May 2021

Table of Contents

• The Pest Management Regulatory Agency (PMRA)
• The consultation
• Overview of comments received
• Addressing stakeholders comments
• Conclusion
• Next steps

The Pest Management Regulatory Agency

Before a pesticide can be registered for use in Canada, the Pest Management Regulatory Agency (PMRA) reviews available scientific test data to determine whether there are concerns for human health or safety, or the environment, when the product is used according to the label. Some of the data reviewed by the PMRA scientists includes Confidential Test Data (CTD). ^{Footnote 1} The PMRA scientists evaluate CTD when conducting risk and value assessments. These assessments are an important part of the decision on whether or not the pesticide can be used in Canada, and under what conditions.

The Pest Control Products Act section 43 provides the public with the opportunity to inspect the scientific test data supporting pesticide registration decisions. Members of the public may inspect the test data in the Reading Room, located at the PMRA's National Head Office in Ottawa, Ontario.

The consultation

On 14 June 2019, the PMRA initiated a 60-day discussion with stakeholders (DIS2019-01) to seek input on a proposal to expand access to CTD, by providing the public the opportunity to inspect this data at the proposed decision stage for post-market reviews (that is to say, re-evaluations and special reviews), rather than only at the final decision stage, as is currently the case. Providing the public with the opportunity to inspect CTD at the proposed decision stage is intended to increase regulatory transparency, help interested parties to understand the scientific basis of regulatory decisions, and facilitate more meaningful public participation in the regulatory decision-making process.

Overview of comments received

In total, five responses were received. Two responses were from industry stakeholders, one from a Non-Governmental Organization (NGO), and two from provincial governments.

Neither industry stakeholder supported the PMRA proposal to provide the public with an opportunity to inspect CTD at the proposed decision stage for post-market reviews. Both stakeholders requested additional clarifications on what material is included under CTD and what is not included under CTD.

The NGO and provincial governments supported the PMRA's proposal for an earlier opportunity for the public to inspect CTD. In addition, both called for the PMRA to establish a means for allowing Reading Room access across the country.

Addressing stakeholder comments

Various comments that were received went beyond what the proposal set out in the consultation document but, nonetheless, are addressed below:

1. Industry stakeholders commented that the PMRA should address challenges with the current re-evaluation program and they would benefit from increased communication prior to initiation of re-evaluation.

PMRA response:

In 2018, the PMRA launched a two-year project to review its post-market pesticide program with the goal of achieving a more modern, efficient and sustainable re-evaluation program. Although the initial focus of the project was on the re-evaluation program, upon further analysis, it was apparent that changes across the full pesticide program were necessary to achieve the goals. This approach also supports the Minister of Health Mandate Letter, issued to the Minister of Health in December 2019, which states: "work to ensure that the Pest Management Regulatory Agency makes timely science-based decisions to support the safe and sustainable use of effective pesticide products in Canada".

In 2019-2020, the PMRA began both internal and external consultations on the design of the integrated approach with a wide range of stakeholders across Canada, receiving broad support. With completion of this extensive engagement, the PMRA is moving forward with Program Renewal and is implementing the new model over the next several years.

The integrated approach will allow the PMRA to be more proactive throughout the pesticide regulatory lifecycle in updating assessments, identifying data needs earlier, and implementing protective measures when necessary. The integrated model incorporates expanded engagement and transparency measures in order to maintain up-to-date data and information, including improved environmental monitoring and use data, over the full regulatory lifecycle of the pesticide.

2. Industry stakeholders indicated that they would appreciate a clear and complete definition of CTD.

PMRA response:

The Pest Control Products Act, section 43, provides the public with the opportunity to inspect CTD that supports a pesticide registration decision. Generally speaking, CTD is data generated during a scientific study conducted by, or on behalf of, a company in support of an application or for the purpose of re-evaluation or special review. CTD does not include scientific data that is publicly available (for example, has been published in a scientific journal).

CTD are not available for inspection when an application is denied, rejected or withdrawn, or if a registration is cancelled immediately following a re-evaluation or special review. CTD supporting pesticides registered before 28 June 2006 are not prepared for inspection until a major regulatory decision (major new use, re-evaluation or special review) requiring public consultation is made under the current Pest Control Products Act. Only data relevant to the decision are made available at that time.

CTD may include data related to:

• Toxicology related to human health
• Bystander and occupational exposure
• Food residue trials
• Environmental toxicology and fate
• Product efficacy, crop tolerance and benefits of the product
• Other scientific data or studies submitted to, or considered by the PMRA

Any personal information or confidential business information ^{Footnote 2} is removed from the CTD before being made available for inspection.

3. Industry stakeholders requested that the PMRA clarify how it conducts its risk assessments. Stakeholders indicated that 90 days provided under the Management of Pesticides Re-evaluation Policy (DIR2016-04) for public consultation is not a sufficient amount of time to thoroughly understand the risk assessment and make meaningful comments.

PMRA response:

The PMRA published in early 2021 a reference document entitled PMRA Guidance Document, A Framework for Risk Assessment and Risk Management of Pest Control Products, which describes the framework that guides Health Canada's PMRA in the assessment and management of risk and its regulatory decision-making. The PMRA uses a comprehensive body of scientific methods and evidence to determine the nature as well as the magnitude of potential risks posed by pest control products. This approach allows for the protection of human health and the environment through the application of appropriate and effective risk management strategies. The document will provide the information for stakeholders to better understand the PMRA's decisions.

In consideration of the need for various stakeholders as well as the public to have adequate time to provide comments and to recommend alternative risk management options, when appropriate, the consultation period for the proposed re-evaluation or proposed special decision document is 90 days from the date of publication. This timeframe is in line with other international jurisdictions such as the European Food Safety Authority and the United States Environmental Protection Agency. The publication of the risk assessment and risk management reference document and the integrated approach to the post-market pesticide program, incorporating assessments, renewal, surveillance and monitoring to create a continuous evaluation and oversight system will allow stakeholders to better and more efficiently utilize the consultation period.

4. Industry stakeholders stated that allowing interested parties to inspect data at the proposed decision stage may result in considerable comments related to interpretations of data that would later be refined or changed.

PMRA response:

While the PMRA acknowledges these concerns, the transparency and openness of its work is critical to maintaining and strengthening public trust in its regulatory decisions.

In addition, the new integrated approach to the post-market pesticide program will allow the PMRA to be more proactive throughout the pesticide regulatory lifecycle in updating assessments, identifying data needs earlier, and implementing protective measures when necessary. This approach will result in minimizing new data submissions at the proposed decision stage and will in turn allow for a more meaningful and productive public consultation.

5. Stakeholders noted that in the interest of transparency and the need to adjust the conditions under which data can be inspected, Reading Room access should not be limited to a single physical site in Ottawa.

PMRA response:

An analysis is underway on the possibility of expanding access to the Reading Room to locations across the country, including the feasibility of a possible "virtual Reading Room".

Conclusion

Following consideration of the comments received from stakeholders, the PMRA will be moving ahead with the proposal to expand access to CTD and providing the public, upon request, with the opportunity to inspect this data at the proposed decision stage for post-market reviews (that is to say re-evaluations and special reviews).

Next steps

• Access to CTD at the proposed decision stage for post-market reviews will be as of 1 January 2022.
• The Inspection of Confidential Test Data Supporting Pesticide Registration Decisions - Guidance Document will be revised to reflect the policy decision outlined above and the related process changes (Fall 2021).
• As noted above, the PMRA will be examining the feasibility of expanding access to the Reading Room across the country and will publish a proposal as soon as it is completed.