PMRA Guidance Document, Structural Pest Control Products: Label Updates

Pest Management Regulatory Agency

28 February 2020

[PDF Version, 187 KB]

Table of Contents

• 1.0 Purpose
• 2.0 Background
• 3.0 Structural Pest Control Product Application Types
• 4.0 Human Health Precautionary Statements
• 5.0 Implementation
• 6.0 Conclusion
• List of Abbreviations
• Appendix I Comments Received on PRO2018-04 and PMRA Responses
• Appendix II Application Type Definitions for Inclusion on Proposed / Registered Labels
• Appendix III Human Health Precautionary Statements for Inclusion on Proposed/Registered Labels
• Appendix IV Droplet Size Categories
• References

1.0 Purpose

The purpose of this Pest Management Regulatory Agency Guidance Document is to inform all stakeholders of standard definitions of application types and human health precautionary label statements for structural pest control products (SPCPs). The revised definitions will provide a uniform language through which all stakeholders in the structural pest control industry can communicate. Also, the human health precautionary statements will help facilitate consistency in the language used for various risk mitigation measures to minimize exposure to those applying the SPCPs and those entering and/or residing in treated areas.

The definitions and precautionary statements apply to both restricted/commercial and domestic marketing class end-use products.

2.0 Background

In December 2018, Health Canada's Pest Management Regulatory Agency (PMRA) published Regulatory Proposal PRO2018-04, Structural Pest Control Products: Label Updates, to update and standardize definitions and human health precautionary statements for structural pest control product labels. This document (PRO2018-04) provided a background of the proposal and information on the focused label improvement initiative. The proposal sought comments from the general public and key stakeholders on the proposed changes to the application type definitions and human health precautionary statements. As a result of the consultation, comments were received from five stakeholders and are summarized in Appendix I of this guidance document. In response to these comments, minor modifications (primarily providing more clarity) were made to the document, which now serves as the basis for this PMRA Guidance Document.

While this document primarily pertains to conventional chemical pest control products, the information provided will be considered when establishing directions for human health precautionary label statements for biopesticides (in other words, microbials, semiochemicals and pheromones, and non-conventional chemical pesticides), when applicable.

Structural Pest Control Products

For the purposes of this document, structural pest control products (SPCPs) are defined as products used to kill/control/repel invertebrate pests that affect a structure or its inhabitants and are applied within, outdoors on the exterior surfaces of, and, within a 1 m exterior perimeter of a structure. Indoor applications may include the contents of the structure, but only when specified on the label. This definition of SPCPs excludes mothballs, termiticides, fumigants, outdoor fogging and outdoor misting systems.

SPCPs can be applied onto surfaces or into the air of structures as either a surface or space application.

1. Surface application - A directed application to a surface (floor, wall, foundation, ceiling, mattress, furniture, etc.). This includes but is not limited to broadcast, perimeter, spot, crack and crevice and void applications.
2. Space application - An application of a pesticide as a suspension of fine droplets in air within an indoor space. This definition does not include fumigants, outdoor fogging and outdoor misting systems.

Structures to which SPCPs are applied include non-food storage/processing areas of residential, farm and office buildings, air, land and sea transport vehicles, and commercial, farm (greenhouses, mushroom houses, etc.) and residential buildings (hospitals, nursing homes, etc.) where food commodities are stored, grown or processed. Excluded are underwater structures.

A structure can be a building or non-building to which a pesticide may be applied. Buildings are considered as any structure used or intended for supporting or sheltering any use or occupancy (NRC, 2015). Types of buildings include but are not limited to homes, schools, offices, animal housing, greenhouses and mushroom houses, factories, food and non-food storage facilities and food processing facilities. Non-buildings are those that are not designed for continuous human or domestic animal occupancy. Types of non-buildings include but are not limited to parking structures, roads/driveways, perimeter barriers such as fences or retaining walls, utilities (such as sewers, drains, telephone poles), patios and decks.

A residential structure is one where the general public, including children, could be exposed during or after application. Residential structures include, but are not limited to, homes, garages, schools, restaurants, hotels/motels, public buildings or any other structures where the general public including children may potentially be exposed. Non-residential structures include, but are not limited to, industrial/commercial indoor sites (for example, laboratories, warehouses, food granaries); modes of transport in areas where passengers are not present (for example, cargo areas, railcars); animal housing (for example, livestock housing, pet kennels); and areas within specific residential structures where the general public, including children, will have no access such as furnace rooms, storage areas in multi-unit dwellings, etc.

Consistency in Label Statements for Structural Pest Control Products

During the scientific review of SPCPs, the PMRA may make changes to the Registrant-provided label statements in order to better reflect the underlying risk assessment, in addition to providing more clarity on statements that communicate risk mitigation measures, the supported use pattern, best practice statements, etc.

To facilitate consistency in this process, the PMRA undertook a focused initiative to standardize the definitions of application types and human health precautionary statements for SPCPs that are used within, outdoors on the exterior surfaces of, and, within a 1 m exterior perimeter of a structure.

The Standard for Pesticide Education, Training and Certification in Canada, specifically the 2005 Structural Module of the Basic Knowledge Requirements for Pesticide Education, and United States Environmental Protection Agency's 2012 Residential Standard Operating Procedures were relied upon as key documents for standardizing application type definitions. The human health precautionary statements were based on statements already present on existing labels or as identified by key stakeholders.

Consultation/Engagement

Key stakeholders within the SPCP industry were engaged with a specific consultation request to provide input on the proposed label statements prior to the publication of the regulatory proposal document, PRO2018-04. Specifically, the Canadian Pest Management Association, CropLife Canada, Canadian Consumer Specialty Products Association and the Federal/Provincial/Territorial Committee on Pesticides and Pest Management were consulted to provide feedback and recommendations on the proposed application type definitions and human health precautionary statements. Through this targeted consultation process, the number of definitions was expanded, definitions were simplified and streamlined, and implementation of the label amendment process was clarified.

Additional stakeholder comments were received during the public consultation period for PRO2018-04 and are summarized in Appendix I. These comments were taken into consideration and minor modifications were made, where appropriate, to the definitions and precautionary statements. The finalized tables are presented in Appendices II to IV.

3.0 Structural Pest Control Product Application Types

The definitions of the most common application types are listed in Appendix II.

These definitions are to be applied on the labels of all formulation types but may have to be tailored/adjusted for non-liquid formulations (dusts, aerosols, etc.), as necessary.

4.0 Human Health Precautionary Statements

The standard human health precautionary statements presented in Appendix III are for the most common uses of SPCPs and for those uses that represent the greatest risk to the applicator and populations exposed to residues after application.

These statements are intended for inclusion by registrants on SPCP labels of the end-use products, when appropriate, based on the use pattern. Over time, these precautionary statements may be updated as new information or data are received and reviewed by the Agency.

5.0 Implementation

To communicate these changes to both commercial and domestic product end-users, the labels of commercial and domestic marketing class end-use products for SPCPs will be systematically amended by using the approaches noted below (1 to 4). The appropriateness of the statements will be determined by both the applicant/registrant and the PMRA, based on the use pattern of the end-use product, any data submitted by the applicant, and level of risk to human health. For example, it is not required that a space spray product label states, "DO NOT apply when a food/feed processing facility is in operation." if PMRA has approved the use in those areas during facility operation.

The training module for commercial pest control operators (PCOs) or pest management professionals (PMPs) will also be updated. The definitions in this PMRA Guidance Document will be used to replace and augment those currently within the Structural Module for Basic Knowledge Requirements under Application Techniques. Changes will be made to the module when it is updated by the Working Group on Pesticide Education, Training and Certification (WGPETC).

• 1) Registered Structural Pest Control Products with an Active Submission

  Changes and updates relating to definitions and human health precautionary statements, as presented in Appendix II and III, to the labels of registered SPCPs not under re-evaluation will be made through an ongoing submission which contains a labelling component.

• 2) Registered Structural Pest Control Products with No Active Submission

  Registrants of SPCPs with no upcoming or active submission can update their labels through a Category C submission within 60 months of the publication of this PMRA Guidance Document.

• 3) Registered Structural Pest Control Products Under Re-evaluation

  As part of the label updates resulting from re-evaluation, registrants will be required to include relevant updates for any SPCPs, taking into consideration the information presented in this PMRA Guidance Document.

• 4) New Structural Pest Control Products

  The proposed labels of SPCPs submitted to the Agency for initial registration must include the definitions and precautionary statements provided in this PMRA Guidance Document.

  If any changes to the definitions or precautionary statements are required for reasons specific to the use pattern of the end-use product, formulation or active ingredient, a rationale must be provided. For example, if the applicant requests to increase indoor perimeter treatment of a building (such as a livestock or animal housing structure) to 1 m from 0.3 m from the wall, a rationale must be provided under DACO 10 to support the need for a larger treatment area based on the activity of the pest. Under DACO 5, the applicant will also need to justify that the additional surface area of treatment will not result in an increase in exposure.

6.0 Conclusion

Implementation of the definitions of application types and human health precautionary statements by the PMRA, stakeholders such as PCOs/PMPs, provincial and territorial pesticide licensing/certification and education bodies, and applicants/registrants will take effect at the time of publication of this PMRA Guidance Document.

The collaborative efforts put forth in the development of these statements will result in greater consistency in the use of these statements and allows a better understanding of how SPCP products are to be used.

List of Abbreviations

PCO

Pest Control Operator

PMP

Pest Management Professional

PMRA

Pest Management Regulatory Agency

PRO

Regulatory Proposal

SPCP

Structural Pest Control Product

VMD

Volume Median Diameter

WGPETC

Working Group on Pesticide Education, Training and Certification.

Appendix I Comments Received on PRO2018-04 and PMRA Responses

Appendix II Application Type Definitions for Inclusion on Proposed / Registered Labels

Appendix III Human Health Precautionary Statements for Inclusion on Proposed/Registered Labels