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Jul 28, 2023 | International
This Guidance Document outlines the general principles of pesticide value assessment in Canada. It describes the types of information that could be provided to register new plant protection products and to support label amendments and provides guidance on summarizing value information prior to submission to the Pest Management Regulatory Agency (PMRA…
Mar 30, 2023 | International
Health Canada’s Pest Management Regulatory Agency (PMRA) invites the public to submit written comments on the publication of limits for solvents of concern in the manufacture of technical grade pest control products. Health Canada will consider all comments received before finalizing the guidance, anticipating that it will be updated as needed.
How to get involved
This consultation is open for comment from 29 March 2023 to 28 April 2023 (30 calendar days). Open the Consultation to access the document.
If you would like to comment, see the Pest Management Regulatory Agency Publications Section page for contact information. Please be sure to include the title of the consultation document on which you are commenting. Interested parties are encouraged to provide comments by 28 April 2023.
Reporting to Canadians
Health Canada will make the results of this consultation available on this website. Once consultation is complete and feedback is incorporated, guidance for residual solvents in technical grade active ingredients will be posted in Registrants and Applicants section of the pesticides portion of Canada.ca.
If you have any questions, contact the Pest Management Information Service.
Interested in our other consultations? Sign up and stay informed about topics that matter to you.
Mar 25, 2023 | International
Health Canada – Pest Management Regulatory Agency
24 March 2023
Summary
This guidance document outlines the regulatory approach for non-conventional pest control products (as defined below). Due to the varied nature of non-conventional pest control products, it can be challenging to define a specific mode of action, identify the active components of a mixture, or delineate a particular level of efficacy that allows innovation and flexibility in assessing that risks to human health and the environment and the value of a product are acceptable.
A wide range of non-conventional pest control products are reviewed under this guidance document. Certain biopesticide products (microbials, semiochemicals and pheromones) have unique information requirements which are outlined in separate publications available under Policies and Guidelines on the Pesticides section of Canada.ca. This guidance document does not replace these documents, and these documents should be used in conjunction with these guidelines when considering registration.
Products eligible for consideration under these guidelines should have one or more of the following characteristics:
low toxicity to non-target organisms (products with low toxicity to humans and other non-target organisms are expected to have minimal environmental and health risks, even if exposure is extensive);
Note: Substances with chronic toxicity, genotoxicity, carcinogenicity, neurotoxicity or immunotoxicity, or that may cause reproductive or developmental effects, metabolize into compounds of toxicological concern, or are anticipated to bioaccumulate are not eligible for review under these guidelines.
low potential for their use to result in significant human or environmental exposure (when exposure is negligible, risks may be minimal even if the product has some inherent toxicity);
not persistent in the environment;
already widely available to the public for other use(s) and with a history of safe use under conditions posing the equivalent potential for exposure to humans and the environment;
pesticidal action that is not the result of toxicity to the target organism (for example, products that work by attracting, repelling, desiccating or smothering pests); or
unlikely to select for pest resistance.
Substances eligible for review under these guidelines could include, but are not limited to:
food items, extracts, preservatives, or additives (for example, crushed garlic, garlic powder, table salt, or citric acid);
plant extracts and oils (for example, vegetable or mineral oils);
commodity chemicals that have a range of non-pesticidal uses (for example, acetic acid); and
other natural materials (for example, diatomaceous earth).
Note: The PMRA has published an addendum to address the unique risks posed by essential oil-based personal insect repellents (Regulatory Directive DIR2017-02, Essential Oil-based Personal Insect Repellents (EOPIR)). Refer to that publication for regulatory requirements.
Document history (revision/update)
Updated:
Update/Rationale:
March 2023
Revised to replace DIR2012-01 as part of PMRA document renewal program.
Feb 2012
Issuance of original.
Disclaimer
This document does not constitute part of the Pest Control Products Act or its regulations and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies.
Note: This guidance update is not a result of the work performed for the PMRA’s current transformation as communicated in April 2022.
This guidance is a reflection of the current process. If changes are required as a result of PMRA Transformation, updates to this document will take place at a later time.
For more information please contact the Pest Management Information Service.
Mar 25, 2023 | International
Health Canada – Pest Management Regulatory Agency
24 March 2023
Table of contents
Disclaimer
1.0 Introduction
2.0 Background
3.0 Eligibility
4.0 Conditions
Disclaimer
This document does not constitute part of the Pest Control Products Act or its regulations and in the event of any inconsistency or conflict
between the Act or regulations and this document, the Act or the
regulations take precedence. This document is an administrative document
that is intended to facilitate compliance by the regulated party with the
Act, the regulations and the applicable administrative policies.
1.0 Introduction
The purpose of this new guidance document is to clarify the eligibility and
conditions for acceptance of Streamlined Category B Submissions.
2.0 Background
With the publication of Regulatory Directive DIR2017-01, Management of Submissions Policy (8 March 2017), new terminology was introduced for submissions with a
limited number of amendments, and requiring only a value assessment:
Streamlined Category B Submissions. These types of submissions were
formerly termed Category C Efficacy Reviews (REG2002-04). On 3 July 2020, in Regulatory Proposal PRO2020-01, the PMRA proposed to increase the number of label amendments permitted
within one of these submissions to six (6).
This guidance document is published pursuant to PRO2020-01 and replaces
REG2002-04.
3.0 Eligibility
Category B submissions that require only value (Part 10) information are
eligible for review as Category B Streamlined submissions, provided that
the request concerns:
a decrease in the use rate;
an increase in the level of control (for example, upgrading to control
from suppression);
the addition of a pest;
the addition of a tank-mix; or
the addition of the general label statement related to tank mixing found
in the PMRA Guidance Document, Tank Mix Labelling.
4.0 Conditions
In order to qualify as a Streamlined Category B submission, the following
conditions must be met.
The total amount of product applied to the crop does not increase as a
result of the amendments (for example, no increase in application rate
and/or number of applications per year).
Products proposed for use in tank-mixes must each be registered for the
specific use site/crop when applied individually; the application rate when
applied as a tank mix partner cannot exceed the application rate when the
product is used alone.
All tank-mix partners must already be registered for the timing (for
example, pre-emergent, post-bloom) and method of application (for example,
soil drench, foliar, aerial) proposed in the tank-mix directions.
A maximum of six (6) label amendments are allowed within one submission.
For example:
The addition of six (6) new pests; or
a decrease in the application rate for three (3) pests already on the
label and the addition of three (3) new pests; or
the addition of one (1) tank mix that is proposed to control five (5)
pests that do not already appear on either tank mix partner label, etc.
