PMRA Guidance Document, Updated Residue Chemistry Guidelines

• Health Canada – Pest Management Regulatory Agency
• 19 October 2022

Summary

The Health Canada Pest Management Regulatory Agency has updated the Residue Chemistry Guidelines to reflect current practices. These guidelines were first made available to registrants and applicants of pest control products in June 1998. The updated guidelines are harmonized with those established by the Organisation for Economic Co-operation and Development (OECD), various elements of which have been adopted and implemented over the years. The PMRA continues to collaborate with OECD countries in the development of test guidelines and guidance documents.

Applicants are requested to utilize residue chemistry guidelines and guidance documents in preparing, conducting, and reporting experimental studies to address the residue chemistry data requirements. These data will elucidate the nature and magnitude of residues in treated foods for purposes of dietary risk assessment and setting Maximum Residue Limits (MRLs). Data waiver requests will be considered when supported by a scientifically defensible rationale.

The harmonization of the PMRA and the OECD test guidelines will continue to greatly facilitate joint reviews and work sharing with international partners.

A phase-in period will be permitted to provide applicants with the time necessary to perform studies as per the updated residue chemistry guidelines and, hence, move towards more consistent data requirements. Studies initiated after 31 December 2023, should be in conformance with these guidelines.

In each study report, the applicant must indicate whether these guidelines have been followed. An explanation must be provided along with details on any deviation.

Applicants are encouraged to refer to the OECD webpage for any updates that may have been issued after the publication of this document.

Document history (revision/update)

Introduction

This Guidance Document, which replaces the Regulatory Directive DIR98-02, Residue Chemistry Guidelines published in 1998, reflects the work that the Health Canada's PMRA has completed through the OECD Residue Chemistry Expert Group (RCEG), the North American Free Trade Agreement (NAFTA), the International Crop Grouping Consulting Committee (ICGCC) and as part of the Regulatory Cooperation Council's (RCC) initiative.

The residue chemistry guidelines are intended to provide guidance on the residue chemistry data requirements that must be addressed to support an application for the registration of conventional pest control products for use on human food and animal feedstuffs in Canada or to support the establishment of a maximum residue limit (MRL) for residues in/on an imported food. The residue chemistry guidelines also provide criteria and protocols for the design, performance, validation, and reporting of scientific studies. These guidelines have been harmonized with the OECD Guidelines for the Testing of Chemicals and OECD Guidance Documents, which were developed over many years, and were adopted by all OECD member countries, including Canada.

The objective of the OECD Test Guidelines and OECD Guidance Documents for pesticide residue chemistry is for use in identifying pesticide residues in human food or animal feedstuffs for purposes of dietary risk assessment and setting MRLs. These OECD Guidelines and Guidance Documents were developed based on guidelines previously in use in OECD member countries and by the Food and Agriculture Organization (FAO).

Applicants are requested to utilize residue chemistry guidelines and guidance documents in preparing, conducting, and reporting experimental studies to address the residue chemistry data requirements. In turn, these data allow for the elucidation of the nature and magnitude of residues in treated foods. International joint reviews and work sharing will continue to be greatly facilitated as a result of the harmonization of the OECD Test Guidelines and Guidance Documents.

It is important to note that applicants are encouraged to consult with the PMRA prior to initiating studies that may deviate from these guidelines or guidance documents.

Revisions to this document will be undertaken as scientific knowledge, evaluation, assessment tools, and/or risk management strategies evolve. Such changes, however, will be made to strengthen guidance and reduce regulatory burden.

For more information, please contact the Pest Management Information Service.