Canada proposes changes in re-evaluation process

The Canadian Pest Management Regulatory Agency (PMRA) invites the public to submit written comments on Regulatory Proposal PRO2016-02, Management of the Pesticide Re-evaluation Process. The process includes changes to enhance engagement, transparency and predictability of the program, such as; early engagement of manufacturers and user associations when needed, clearer timelines for PMRA and industry, limits on the consideration of new information and requests for expansion of the pesticide use pattern, and a longer comment period for consultations on proposed decision documents. This proposal is being distributed for information and comments. The PMRA will accept written comments from the public on this proposal until May 31.

 

The Pest Control Products Act requires the PMRA to initiate re-evaluations for each registered pesticide on a 15-year cycle, based on either its initial registration or the most recent major decision affecting the registration. The PMRA will inform the public of upcoming re-evaluation documents by publishing a multi-year work plan for the program, which will be updated annually. 
 

Re-evaluations are typically conducted in chronological order as initiated. There may, however, be situations where to maximize efficiency, the PMRA will align Health Canada’s re-evaluation schedule with that of another international regulatory body or other parts of the Canadian federal government for work-sharing or collaboration purposes. PMRA will also continue the current practice of ongoing communication with other regulatory authorities regarding relevant science or regulatory issues.
 

The initiation date of the re-evaluation of an active ingredient will be generally based on the date of its initial registration. If there has been a more recent major regulatory decision of a type also referred to in section 28(1) of the Pest Control Products Act (such as a major amendment of the registration) this may be taken into consideration when determining the initiation of a cyclical re-evaluation. Upon the issuance of an initiation notice (under Pest Control Products Act Section 16) to the registrant(s), the data provider (typically the registrant of technical grade active ingredient) will be provided with 30 days to confirm their support for the re-evaluation. If none of the registrants provide support, all product registrations will be discontinued and the re-evaluation file will be closed. If support is provided, however, the re-evaluation will then move to the scoping step (120 days).
 

In general, the scoping exercise will identify whether a re-evaluation will be of low, medium or high complexity. A re-evaluation is considered to be of low complexity if all components of the re-evaluation may be adequately addressed by previous reviews and a detailed new evaluation is not warranted or the product labels may only need to be updated to meet current labelling requirements. A re-evaluation of medium complexity would typically not require additional information gathering, yet would include a detailed evaluation in some areas, such as revising risk assessments using current assumptions or more precise drinking water estimates. High complexity re-evaluations, which have the longest projected timeframes, are typically ones in which more information will be required (described in Section 4.3) in order to proceed with updating risk assessments. 
 

As noted above, the scoping exercise may determine that additional information is needed before proceeding to reviews. The information gathering phase will be 90 days. In these cases, the following substeps could be included:
 

• Early stakeholder engagement – For certain complex re-evaluations, the PMRA may engage registrants and key stakeholders such as product user associations in collecting information to clarify parts of the current use pattern for an active ingredient in Canada. This information would help to reduce uncertainties that could result in conservative assumptions during the risk assessment (such as assuming that users apply the maximum number of product applications).

• Verification of Use Pattern – The PMRA will also require the registrants to gather and provide information that will confirm the use pattern, in order to arrive at the most realistic basis for the PMRA risk assessments based on current usage; information that may include extent of use, details of certain application scenarios, etc.

• Data Call-In – The PMRA will issue a request for additional information and/or studies when considered necessary to conduct the re-evaluation. A data call-in notice will be issued to the registrant (data provider) under the authority of Section 19 of the Pest Control Products Act. PMRA also sends a notice of the re-evaluation to other federal and provincial government departments, as per subsection 16(4) of the Pest Control Products Act.

 

At this point, a project plan document, outlining the anticipated focus of the re-evaluation, any additional information and/or new data required to proceed (that is, data call-in) as well as the associated timelines, may be published to Health Canada’s website for public information.
 

Whether or not an information gathering step is needed, the re-evaluation will proceed to a review stage. The scoping step will have determined the depth and areas of evaluation that are needed, which will inform the estimated time to complete the evaluation. In this stage, evaluations will be conducted on the health and environmental risks, along with the value of the pesticide active ingredient and associated products. This step will include both risk assessment and risk management (that is, development of the proposal for additional mitigation of risks such as changes to product labels, removal of uses or cancellation of products), as well as related internal decision-making and preparation of the proposal document for publication.
 

For improved predictability to meet expected timelines, it is important that once the re-evaluation review stage begins, PMRA can proceed to complete these evaluations, without the need to consider further changes to the use pattern. Experience has shown that pre-market submissions that seek to add new uses through registration amendment cannot accurately reflect the findings of re-evaluation reviews on the same active ingredient until that work is completed. Nor can the re-evaluation incorporate the latest use pattern if this is constantly changing. For this reason, as part of this new process, PMRA will not advance the reviews of pre-market submissions requesting expansion of the use pattern for the active ingredient, until the re-evaluation risk assessment is completed.
 

Additionally, unless requested by PMRA for clarification, no new data or information will be considered during the review step (that is, once the 90 day Information Gathering step is completed). In the past, significant additional work has been required for PMRA to consider studies or new use information provided by registrants after risk assessments have been completed or to wait for studies that were under development to submit to other regulatory agencies. This practice will no longer be included in the process. However, it should be noted that if new information demonstrating increased risk does become evident (for example, submitted through the Incident Reporting program) PMRA will take this into account. In exceptional cases, if the initial risk assessment warrants, PMRA may publish a preliminary risk assessment as part of this review stage, to obtain specific information that would result in a more robust assessment, prior to proceeding with the development of the risk management proposal.
 

• Low – time estimated for review, internal decision-making and preparation of the document for public consultation is 360 days from the end of scoping step.

• Medium – time estimated for review through to document publication is 420 days from the end of scoping step.

• High – excluding the 90 days for information to be submitted, the time estimated for review through to document publication, is 650 days from the end of information gathering step.
 

The PMRA will publish a proposed re-evaluation decision document (PRVD) for consultation. The consultation period for the PRVD document will now be 90 days (instead of 60 days) from the date of publication. In order to proceed to regulatory decisions in a timely and predictable manner, however, extensions to this period will not be granted, nor will the re-evaluation be placed “on hold” in anticipation of studies being prepared for other regulatory agencies.
 

The timelines expected to complete Final Decision step range from 90 days (if no comments) up to 365 days (significant comments and review required). If, as a result, there are significant changes from the original proposal, the PMRA will provide a verbal pre-publication briefing up to two weeks before the document publication date, similar to that for the PRVD.
 

The PMRA’s performance standard for re-evaluations will be that 80% of the re-evaluations will be completed within the timeframe outlined in the five-year work plan.
 

This process will apply to all pesticide active ingredients that will be initiated under cyclical re-evaluation beginning on 31 August 2016. It will also be implemented for re-evaluations previously initiated by the PMRA, where appropriate, for the remaining steps of those re-evaluations.

Re-evaluation process flowchart