ARCHIVED - Memo: Strategy for the Implementation of SPN2008-01, The Application of Uncertainty Factors and the PCPA Factor in the Human Health Risk Assessment of Pesticides

29 July 2008

1.0 Purpose

On 29 July 2008, Health Canada's Pest Management Regulatory Agency (PMRA) published Science Policy Notice SPN2008-01, The Application of Uncertainty Factors and the PCPA Factor in the Human Health Risk Assessment of Pesticides. The Science Policy Notice is the product of a consultative process undertaken by the PMRA. The aim of the process was to develop a framework for applying factors to address uncertainty and variability in the mammalian toxicity database during pesticide risk assessment. The Notice also describes how the factor, specified under the Pest Control Products Act, is applied to protect infants and children.

This document describes the PMRA's strategy to implement the Science Policy Notice. One of the key considerations in developing the strategy was to minimize resource requirements so that ongoing timelines for new submissions and re-evaluation would not be affected. The strategy addresses new submissions that require full risk assessment, open submissions that require full risk assessment as well as closed submissions (i.e. registered products).

2.0 New Submissions

All new submissions received by the PMRA that require a full risk assessment (toxicological and exposure assessment of active ingredient), such as submissions for a new active ingredient or major new use of an already registered active ingredient, are now subject to SPN2008-01.

3.0 Open Submissions

The Science Policy Notice applies to submissions that require a full risk assessment. For these submissions, the PMRA has been applying SPN2008-01 since January 2008.

Stage of Submission1 Approach
1. Pre-proposed decision2 Apply SPN2008-01
2. Post-proposed decision2 but prior to publication of PRD or PRVD Maintain existing risk assessment; deferred to pre-decision stage below
3. Pre-decision2

For active ingredients where there was no significant change proposed to conditions of use, maintain existing risk assessment

For active ingredients where there was a significant change proposed to conditions of use, apply SPN2008-01

4. Post-decision2 but prior to publication of RD or RVD Maintain existing risk assessment

1 The stage of each submission as of January 2008 determines the approach taken.
2 Decision in this context refers to the decision made by the PMRA Science Management Committee.

Nearly all submissions in stages 2 through 4 since January 2008 have now been examined. Submissions have been handled as noted above.

4.0 Closed Submissions

The PMRA acknowledges that there may be some interest among stakeholders to have certain risk assessments revisited in accordance with SPN2008-01. Revisiting previously conducted risk assessments can require significant resources. Therefore, the PMRA has chosen not to apply the policy retroactively. However, the risk assessments of registered active ingredients will be revisited in accordance with SPN2008-01 at the time of re-evaluation. For active ingredients with a conditional registration, the risk assessments will be revisited only if the receipt of conditional data warrants a new health risk assessment.

5.0 Questions

Questions concerning the implementation strategy should be directed to the Pest Management Information Service.

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