Regulatory Directive: Assessment of the Economic Benefits of Pesticides

October 28, 1993
ISBN: N/A
Cat. No.: N/A
(DIR93-17)

This Regulatory Directive is intended to provide registrants of pesticides and other interested groups with a guideline for assessing economic benefits for pesticide products involving a new active ingredient or major new uses of an active ingredient. This document has been structured to cater to pesticides used in agriculture, forestry and possibly other applications. Several types of pesticides will not, however, be covered-particularly those used as antimicrobials.

This Regulatory Directive replaces Memorandum to Registrants R-90-05, dated October 10, 1990, and provides further details on Section 8.4 of Appendix I of Regulatory Directive Dir93-03.

The need for an economic benefits guideline has been expressed in various quarters. Accordingly, Policy Branch and the Plant Industry Directorate of Agriculture and Agri-Food Canada have worked in conjunction with a committee of the Crop Protection Institute of Canada to develop this guideline.

This document does not attempt to address benefits other than economic ones. For example, the special benefits of products that adapt well to Integrated Pest Management programs, or products which may have certain safety features that are desirable are beyond the scope of this guideline. With some adjustments, however, this document may provide the basis for benefit assessments for pesticides under reevaluation.

Reason for Benefits Assessments

Difficult situations arise when the scientific data base supporting the registration is less than ideal. Similar conditions occur when the risks presented by the use of the chemical appear to be significant for users, consumers and non-target organisms. In certain instances, risks may be so great that benefits of any kind may not overcome them. In other situations, risks appear to be manageable. In these cases, it is useful to have documentation of the benefits, risks and the risk management procedures available

Formal documentation of the benefits is an important part of the regulatory decision making process. It is necessary to be aware of the benefits of the registration, the ensuing or continued use of a pesticide, as well as the negative impact of a decision not to register, to cancel or suspend the use of a given pesticide.

Information Submission

Information submitted in support of the Economic Benefits Assessment must include the actual field test data or published reports from which the summary is derived. Details and proposed content for the Economic Benefits Assessment package are outlined in Appendix 1.

This package provides further details on Section 8.4, Economic benefits, of Regulatory Directive Dir93-03. The information should be submitted according to the format in Appendix II (Part 8.4 Pesticide Benefits).

It is important to identify the limitations of the data and information contained in the submission. Where there are limitations on key variables, sensitivity analysis should be undertaken and included in the submission. One must document both the assumptions used and the limitations of the analysis when lack of analytical resources or data preclude a more rigorous study.

Confidentiality of Data

It is suggested that any information provided in the Summary Report (Part 8.4.2) could be made accessible to the public by Agriculture and Agri-Food Canada without first requesting written agreement of the registrant/applicant. The information submitted as a part of the regular data package (8.4.3-8.4.7) will be maintained confidential in so far as it is governed by the provisions of the Access to Information Act.

For example, if the registrant does not wish to reveal the possible retail price of the pesticide, this information may be reported in Part 8.4.5 of the submission, while the Summary Report (8.4.2) may refer to the price by stating that the pesticide in question will be competitively priced with an alternative chemical.

Please direct any inquiries regarding this Regulatory Directive to:

The Information Service
Pest Management Regulatory Agency
Health Canada
2250 Riverside Drive
A.L. 6606D1
Ottawa, Ontario K1A 0K9

Appendix I

Appendix II

Part 8.4 Economic Benefits

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2017-05-04