Regulatory Proposal PRO2016-01, Revised Environmental Data Requirements

Pest Management Regulatory Agency
4 May 2016
ISSN: 1925-122X (PDF version)
Catalogue number: 1925-122X (PDF version)

Summary

Table of Contents

• 1.0 Introduction
• 2.0 Revised Data Requirements
• 3.0 Guidance for Applicants
• 4.0 Next Steps

1.0 Introduction

Environmental data submitted to the Health Canada Pest Management Regulatory Agency (PMRA) provides essential insight into the potential impact of a pesticide on the environment and are the foundation of the environmental risk assessment. Environmental data requirements were first developed more than 15 years ago and were recently updated to incorporate scientific advancements and address an overall need for clarity.

The purpose of Regulatory Proposal PRO2016-01, Revised Environmental Data Requirements is to communicate the revised environmental data requirements to industry and other interested parties. This proposal also presents guidance to assist applicants when preparing the environmental portion of the data package. Revisions presented in the current document would supersede environmental data requirements outlined in Organizing and formatting complete submissions for pest control products: PMRA guidance document.

This proposal applies to conventional pesticides only. Data requirements for the registration of antimicrobial products will be examined at a later time. The registration of non-conventional products is discussed in PMRA Guidance Document, Registration of Non-Conventional Pest Control Products.

2.0 Revised Data Requirements

Revised environmental data requirements are presented in Appendix I Regulatory Proposal PRO2016-01, Revised Environmental Data Requirements.

Two aspects were considered when revising the environmental data requirements. First, the relevance and adequacy of each data requirement was examined in light of current science. Also, their classification (required/conditionally required/not required) was updated within the different use-site categories. Main highlights include:

• New data requirements were created to reflect recent updates to the pollinator risk assessment framework.
• Requirements that no longer reflect current risk assessment approaches were eliminated.
• Many data currently classified as CR (conditionally required) were converted to NR (not required) or R (required) to improve the predictability of the data requirements.
• No environmental data are required for some uses.

Overall, the revisions better relate data requirements to the potential for environmental exposure, thereby improving predictability and transparency. Changes should help applicants understand the logic behind data requirements and allow the public to be better informed of the considerations taken during an environmental risk assessment.

The new approach does not lessen our level of scrutiny when evaluating environmental risk but rather streamlines the approach by eliminating studies that are rarely used while clearly identifying studies that are required.

Revisions should not impact our ability to carry out joint reviews and collaborate with other governments. In particular, care was taken in aligning the data requirements as much as possible with those from the United States Environmental Protection Agency.

3.0 Guidance for Applicants

Appendices II, III and IV of Regulatory Proposal PRO2016-01, Revised Environmental Data Requirements provide information on when and why certain environmental data are to be included in a data package.

Data requirements are not intended to constitute a rigid list of data to be submitted in all cases, but rather serve as a guide. Some of the required data may not be relevant in certain situations or may not be applicable to all uses within a given use-site category. Conversely, it may be appropriate to supplement the data package with data other than those required in the tables to address issues specific to the pesticide itself or to its use pattern.

4.0 Next Steps

PMRA invites the public to submit written comments on the proposed revisions up to 45 days from the publication of Regulatory Proposal PRO2016-01, Revised Environmental Data Requirements. Please forward all comments to PMRA Publications. PMRA will consider all comments received before making a final decision on the revised environmental data requirements.