Health Canada's response to the Commissioner of the Environment and Sustainable Development 2015 audit on Pesticide Safety

The Agency's response

Agreed. Since 2008, the Pest Management Regulatory Agency has taken action to limit the number of conditional registrations, which are used only where risks have been deemed acceptable and where additional, confirmatory information has been considered desirable. Currently, one percent of pesticide registrations are conditional in nature; most of these have been conditional for less than five years. Some pesticides have been conditionally registered for longer periods, mainly because the Agency has required information that would take multiple years to generate (for example, new types of scientific studies to be carried out).

The Agency believes it could be possible to eliminate the use of conditional registrations and is developing options towards that goal. Stakeholders will be consulted on any proposed change in policy.

For the remaining conditional registrations, on a bi-annual basis, the Agency will post a status report on conditional registrations, including whether the requested information has been received, the actions that have been taken, and the performance in reviewing the data within the two-year timeline. Where necessary, the Agency will use existing authorities in the Pest Control Products Act to ensure that the requested information is provided according to the established timelines.

Planned management actions

• Finalize decision on whether to eliminate the future use of conditional registrations
• Improve transparency of remaining conditionally registered products
• Use existing authorities, where appropriate, and engage in more active oversight in an effort to ensure that requested information is provided according to the established timelines

Deliverables

• Completed: List of pesticides conditionally registered including the conditions of registration (published to Canada.ca, 2016)
• Completed: Publish a bi-annual status report to clearly identify which products are conditionally registered, the conditions of registration, when confirmatory data is due / received, outcome of review, and review performance (September 2016 and ongoing)
• Completed: Consultation document on whether to eliminate the use of conditional registrations
• Completed: Publish a final decision on whether to eliminate the future use of conditional registrations. The Pest Control Products Regulations (PCPR) was amended to bring this policy approach into law. As of November 2017, it is no longer possible to issue new conditional registrations under the PCPR.

The Agency's response

Agreed. The Pest Management Regulatory Agency agrees with the recommendation and the importance of ensuring that the cumulative effects of pesticides are considered where necessary.

This is an emerging area in the science used to regulate pesticides, and the Agency is actively working with international partners to understand how to best apply these principles to protect the health and safety of Canadians. Most countries, including Canada, are working on a cumulative risk assessment methodology for pesticides. However, the international scientific community has not yet reached a consensus on how to best assess the cumulative effects of pesticides.

The Agency anticipates having its own methodology for cumulative risk assessments in place in the 2017 to 2018 fiscal year.

Planned management actions

• Complete and apply a methodology for cumulative risk assessments by 2017 to 2018

Deliverables

• Completed: PMRA's approach to assessing cumulative effects of pesticides
• Completed: Consultation on a Cumulative Risk Assessment Framework (March 2017)
• Completed: Publish final Cumulative Health Risk Assessment Framework (April 2018)
• Completed: Since 2017, PMRA’s published documents indicate whether a cumulative risk assessment is required, and where possible, also including the cumulative risk assessment. For the more complex assessments, the first phase is to complete individual chemical assessments and identify those that have a common mechanism of toxicity. Once all chemicals within a common cluster have been assessed, PMRA will initiate cumulative health assessments, as appropriate.

The Agency's response

Agreed. The Pest Management Regulatory Agency has completed the majority of its re-evaluations of active ingredients registered before 1995 and is committed to completing the remainder of the re-evaluations by 2020. The Agency continues to make progress on the remaining 46 and, where necessary, has implemented interim measures to further protect health and the environment during the review process.

The Minister of Health's multi-stakeholder Pest Management Advisory Council recently supported the Agency's three-year re-evaluation work plan. The Agency will update the current work plan, in collaboration with the Council, in order ensure that the remaining 46 re-evaluations are completed by 2020. In completing the re-evaluations, the Agency will collaborate with other foreign regulators, as appropriate, including the United States Environmental Protection Agency.

The Pest Management Regulatory Agency will continue to report on progress on an annual basis.

Planned management actions

• Consult the Pest Management Advisory Council on the updated multi-year re-evaluation workplan, and revise accordingly
• Publish a revised multi-year re-evaluation workplan, to be updated annually
• Collaborate with other foreign regulators, including the United States Environmental Protection Agency, as appropriate
• Report on the progress of the re-evaluation of the remaining active ingredients registered before 1995 in PMRA's annual report to Parliament

Deliverables

• Completed: Present the revised multi-year re-evaluation workplan at the next Pest Management Advisory Council meeting (February 17 to 18, 2016)
• Completed: Publish the new multi-year re-evaluation workplan (February 2016), and update annually
• Ongoing engagement and collaboration with stakeholders
• Completed: Provide a progress update in PMRA's Annual Report (December 2015 and annually)

The Agency's response

Agreed. The Pest Management Regulatory Agency will publish updated work plans in early 2016 and update them on a yearly basis. These will include clear expectations for timelines, as well as the expected publication date of the final re-evaluation decision.

The Agency's current approach to re-evaluation favours receipt of new information, including incident reports, from any and all stakeholders even where this material might arrive very late in the review process. While this approach helps ensure re-evaluations are based on the latest and most complete set of information available, it unfortunately often delays the final decision as the Agency must then reconsider its assessment. To address this challenge and to meet pre-established timelines, the Agency will consult on and develop a policy with clear rules and criteria for submitting information in order to make timely decisions.

Planned management actions

• The revised multi-year re-evaluation workplan mentioned at Recommendation 3 will include clear timelines for all re-evaluations (of active ingredients registered before 1995 and cyclical re-evaluations) and special reviews to the final decision stage
• Develop a process for the management of re-evaluations, including the timely submission of information in support of re-evaluation decisions

Deliverables

• Completed: Publish and update annually the multi-year re-evaluation workplan mentioned at Recommendation 3
• Completed: Publish a consultation document on a proposed process for the management of re-evaluations, including the rules and criteria for submission of information in support of re-evaluations (March 2016)
• Completed: Publish and implement the final Management of Pesticides Re-evaluation Policy (November 2016)

The Agency's response

Agreed. The Pest Management Regulatory Agency agrees that unacceptable risks presented by pesticides should be addressed promptly.

Where unacceptable risks are identified but can be appropriately addressed through mitigation measures, the Agency acts promptly to require such measures. These can range from cancellation of certain uses, to the enhancement of the use of personal protective equipment by workers, to the implementation of additional application restrictions.

Where risks are imminent and no appropriate mitigation measures exist, the Agency's policy is to cancel all uses.

In some circumstances where risks are only considered unacceptable in the context of very long-term usage, and where mitigation measures can be put in place as an effective interim solution, the Agency may implement a phase-out period commensurate with the level of risk. This approach ensures the protection of human health and the environment and provides lead-time for improved products to be introduced. The use of orderly product phase-outs, where risks can be mitigated in the interim, is a widely accepted practice in use by the United States Environmental Protection Agency and other advanced economies.

In 2016, to improve transparency, the Agency will consult publicly on its current approach for establishing a phase-out of products (including extensions).

Planned management actions

• Analyze, develop and consult on PMRA's approach for establishing phase-out schedules

Deliverables

• Completed: Consult publicly on the Policy on Cancellations and Amendments Following Re-evaluation and Special Review (December 2016)
• Completed: Publish the final approach document (March 2018)

The Agency's response

Agreed. At present, while some information on which products are conditionally registered and their associated conditions is currently available on the Pest Management Regulatory Agency's section of Health Canada's website, other information is provided to members of the public upon request.

Recognizing the importance of promoting greater transparency in the regulation of pesticides, the Pest Management Regulatory Agency is constantly striving to find ways to more effectively communicate information on conditional registrations with regulated parties, affected stakeholders and all Canadians. In 2016, all conditions associated with conditional registrations will be published on the Health Canada website.

Planned management actions

• The public registry will be updated, and will include all necessary information on conditionally registered products 

Deliverables

• Completed: A list of conditionally registered pesticides, including the conditions of registration, is available on PMRA’s website and updated biannually.

The Agency's response

Agreed. The Pest Management Regulatory Agency acknowledges that the current communication of the information can be improved by clearly identifying which products (rather than active ingredient) are implicated. Recently, the Agency has increased the clarity of its regulatory documents by including timelines for the implementation of regulatory decisions.

In 2016, the Agency will identify further opportunities to improve communication with stakeholders and the Canadian public regarding the removal of pesticides or their uses, and the associated timelines. The Agency will also revise decision documents to provide a clear summary of the products it has decided to remove from the market, what uses it has decided to cancel, what mitigation measures it has decided to put in place, and when these changes will take effect.

Planned management actions

Improve the communications of re-evaluation decisions by:

1. Amending new regulatory decision documents in order to better identify:
   • which products are removed from the market
   • what uses are prohibited
   • new mitigation measures
   • when changes will take effect
2. Improve the communication of regulatory decisions

Deliverables

• Completed: New mobile app that allows users to access pesticide labels
• Completed: Consult with the Pest Management Advisory Council to explore options for enhanced communications and outreach regarding re-evaluation outcomes (February 17 to 18, 2016)
• Completed: As of November 2017, proposed and final re-evaluation decision documents identify:
  • Which products/uses are proposed to be removed from the market;
  • Which uses will no longer be permitted; 
  • Proposed mitigation measures to protect health and/or environment;
  • Proposed timeframe for when these changes will come into effect.
• Completed: Increased outreach to specific user and stakeholder groups when proposed decisions require additional information to refine the risk assessment, or when risk management actions are proposed (example, new use directions, or removal of products from the marketplace). Increased outreach is also conducted when the final decision for products requiring significant new risk mitigation measures is published.
• Completed: Final re-evaluation decision documents have been improved to indicate the timeframe for implementing decisions, and which products are impacted.