Instructional guide: Submitting a Notice of Objection

Health Canada – Pest Management Regulatory Agency

Instructions

Please follow these instructions/steps for submitting a Notice of Objection to Health Canada's Pest Management Regulatory Agency (PMRA). Not adhering with these steps can lead to your request not being considered by the PMRA.

1. The eligibility for consideration of your Notice of Objection is dependent on the following conditions. The Notice of Objection must:

• Relate to decisions made under paragraph 28(1)(a) or (b) of the Pest Control Product Act. This includes a decision: to register a new active ingredient (RD) or a major new use of an active ingredient (RD), a re-evaluation (RVD), or a special review (SRD).
• Be submitted within 60 days of the publication of the final decision (i.e., RD, RVD, or SRD).
• Have scientific basis and evidence to support the objection. The evidence was available at the time the final decision was made, and raises concerns about the validity of the final decision.
• Provide a copy of the supporting scientific evidence/references cited in the objection letter, such as scientific literature (e.g., peer-reviewed journal articles, studies), scientific data (e.g., reports, test data, empirical data), or regulatory comparisons (e.g., findings from international pesticide regulators such as the United States Environmental Protection Agency (EPA) and the European Food and Safety Authority (EFSA)).

2. When submitting the Notice of Objection, the Public Engagement Portal must be used to submit the online form and the accompanying supporting documents. The Notice of Objection is required to include the following information:

Attachment 1

A detailed objection letter that:

• Clearly states/identifies the area of science to which the objection relates. For objections related to human health risk, the letter needs to specify if the concerns are related to toxicology, food residue, and/or occupational/residential exposure. Similarly, for environmental risks, specify environmental fate and/or environmental toxicology (terrestrial and aquatic organisms). For value, specify efficacy, crop tolerance and/or benefit information;
• Enumerates each science-based objection (see example below);
• Includes an objection statement with scientific rationale and corresponding evidence to support each of the objection;
• Includes an explanation on how the scientific evidence/cited reference raises scientifically founded doubt as to the validity of PMRA's science assessment and conclusions.

For example, for each objection:

Heading/Title: Area of science – e.g., Environmental Risk – Environmental Toxicology; Risk to Aquatic Invertebrates

Objection #1: Objection statement

Scientific rationale and evidence to support objection statement

• explanation of how the evidence/cited reference supports the objection statement.

Attachment 2

A summary table that clearly identifies and summarizes the area of science, objection number (this needs to correspond with how the objection is presented in the letter), and title of cited reference(s) with author and year.

• If the same reference is cited for multiple objections, please clearly specify how the reference supports each objection, including the relevant page number(s) or section(s).
• Only references published prior to the publication of the final decision may be cited.

For example, summary table for each objection, as identified in the letter:

Include electronic copies of all the references cited in the objection letter to be submitted using the e-mail address: pmra.noo-ado.arla@hc-sc.gc.ca with the subject line: 'Active Name' – 'Registration decision' (i.e., RD2025-XX).