Classification Harmonization for Canada, A Proposal for Domestic Class Pesticides, 2007

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June 15, 2007

Consultation Document

Prepared by the Federal/Provincial/Territorial Committee on Pest Management and Pesticides

The Federal/Provincial/Territorial (FPT) Committee on Pest Management and Pesticides brings together federal and provincial/territorial pesticide officials to exchange information and expertise. Building on previous work, stakeholder input and new developments, the FPT Committee has developed this consultation document which outlines the proposal Classification Harmonization for Canada, A Proposal for Domestic Class Pesticides, 2007

Table of Contents

• Executive Summary
• 1. Introduction
• 2. Background
  • 2.1 Current Classification Systems
    • 2.1.1 Federal Class Designations
    • 2.1.2 Provincial Classification Systems
• 3. Proposal for Domestic Class Pesticides
  • 3.1 Provincial Control of Domestic Class Products
  • 3.2 Proposed Vendor Requirements
  • 3.3 Proposed Exemptions
• 4. Implementation
  • 4.1 Federal
  • 4.2 Provincial
• 5. Appendices
  • Appendix 1 - Biopesticides (microbials and biochemicals) proposed for inclusion in the Self-Select category regardless of formulation type or container size (Domestic class only)
  • Appendix 2 - Lower risk pesticides proposed for inclusion in the Self-Select category regardless of formulation type or container size (Domestic class only)
  • Appendix 3 - Active ingredients/Pesticide types proposed for inclusion in the Controlled Purchase category regardless of formulation type or container size
  • Appendix 4 - Pesticide Product Types proposed for Provincial Exemption
• 6. Glossary

Executive Summary

The Federal/Provincial/Territorial (FPT) Committee on Pest Management and Pesticides proposes to harmonize the existing federal and provincial classification systems for domestic class pesticides (also known as pest control products) to improve the management of pesticides across all provinces.

Currently, federal procedures for classifying products use hazard criteria as the trigger for determining if products can fall into the Domestic Class. This proposal would retain the existing procedure, but add a further subdivision of Domestic Class products. Using the criteria described below, products will be placed into two separate groups: 1) those that are suitable for unrestricted domestic sale, and 2) those for which the purchase will be controlled by a vendor.

Products which are appropriate for unrestricted domestic sale (i.e., the "Self-Select" category, or SS) are typically in a Ready-to-Use formulation and packaged in smaller sized containers; products which are appropriate for controlled sale by a vendor (i.e., "Controlled Purchase" category, or CP) typically require mixing or dilution and/or are packaged in larger sizes (i.e., greater than 1 kg or 1L). This categorization will advise provincial regulators which products will require additional controls (i.e., CP products) under appropriate provincial regulations.

The subdivision of Domestic class products into two categories will guide users towards risk reduction by identifying products that can be used with the least amount of exposure. Application of this classification framework at the federal level will result in clear and predictable outcomes, with better utilization of federal and provincial resources.

Full implementation, apparent at the vendor level, will be dependent on adoption of the required regulations by the provinces. Further conditions of access of consumers to those Domestic products identified as Controlled Purchase will be determined by those provincial regulations. Consumers will continue to have direct access to Self-Select domestic products from the major product types (e.g., insecticides, herbicides, fungicides). Domestic rodenticides will be categorized as Controlled Purchase products.

Provincial restrictions on the sale of Controlled Purchase products, using a harmonized approach, will contribute to minimizing risks to the health of pesticide users and to the environment.

1. Introduction

Pesticides, or pest control products, include:

• Insecticides (i.e., products to control insects)
• Herbicides (i.e., products to control weeds)
• Fungicides (i.e., products to control fungal diseases)
• Algicides (i.e., products to control algae)
• Bactericides (i.e., products to control bacteria)
• Rodenticides (i.e., products to control rats and mice)
• Avicides (i.e., products to control birds)
• Piscicides (i.e., products to control fish)
• Mollusicides (i.e., products to control molluscs and snails)

The protection of the Canadian public and the environment from unacceptable risks posed by pesticides has traditionally been achieved through complementary regulatory systems at the federal and the provincial levels.

Under the federal Pest Control Products Act (PCPA), the Pest Management Regulatory Agency (PMRA) of Health Canada is responsible for registering pesticide products for use in Canada. A pesticide must be registered under the PCPA before it can be manufactured, possessed, handled, stored, transported, imported, distributed or used.

As a part of federal registration, pesticides are assigned broad class designations (e.g. domestic, commercial, restricted) which support/guide provinces and territories in determining who can sell and use the products. Further restrictions on the sale and use of pesticides can be achieved through provincial regulation.

Several provinces have established their own provincial classification systems that build on the broad, federal class designations. Other provinces use the federal classification designations without modification to regulate the sale and use of pesticides.

Over time, it became apparent that there would be benefits in harmonizing the regulatory classification systems. It was recognized that a harmonized classification system would offer many advantages and opportunities. For domestic class products, these include:

• improved efficiencies in the federal and provincial regulation of pesticides;
• a standardized approach to provincial requirements on the sale and use of pesticide products, and vendor training;
• improved potential to guide users towards risk reduction, i.e., by using pesticides that are the most suitable for the pest problem and that can be used with the least amount of exposure.

This proposal focuses on the classification of domestic class products and their subdivision into two categories:

• Self-Select: those products that can be purchased and used by homeowners without any particular instructions or advice at purchase and in quantities suitable for common pest problems in and around the house; and
• Controlled Purchase: those products that can be safely used by homeowners but would benefit from professional advice from a qualified vendor with respect to use instructions, their appropriateness for particular pest problems or quantities that exceed average homeowner usage.

2. Background

In 2002-2003, the Classification Implementation Working Group (CIWG) of the Federal/Provincial/Territorial (FPT) Committee on Pest Management and Pesticides conducted a 90-day national consultation on an initial harmonization proposal document entitled A Proposal for a Harmonized Pesticide Classification System for Canada (http://www.pmra-arla.gc.ca/english/pdf/fpt/ciwg/ ciwg_propdoc-e.pdf). A consolidated summary report on the comments received was prepared (http://www.pmra-arla.gc.ca/english/pdf/fpt/ciwg/summary20050624-e.pdf).

The FPT Committee has developed this proposal taking into consideration:

• comments from stakeholders submitted during the initial November 2002 consultation process on a harmonized system;
• the practicality of applying criteria to classify domestic products in the most efficient way;
• existing exclusions of certain product categories from provincial regulations;
• products determined by the Pest Management Regulatory Agency (PMRA) to be of 'low risk'; and
• the timing and relationship of other initiatives underway in the PMRA and internationally (e.g., the Globally Harmonized System for the classification and labelling of chemicals).

This new proposal for sorting domestic class products is based on criteria that limit the potential for exposure of users and thus contribute to reducing potential risks from the use of these products by the general public.

2.1 Current Classification Systems

"Classification" allows the grouping of pesticides into categories, to apply differential controls on their sale and use, in order to reduce risks and protect human health and the environment.

2.1.1 Federal Class Designation

Pesticides are currently classified into one of the following classes: Domestic, Commercial, Restricted or Manufacturing. These designations are based on:

• intended market (e.g., commercial, agriculture or general public use);
• hazard criteria and, in the case of Restricted class, on potential risk;
• use-site (e.g., products intended for direct application to forests).

The current Domestic class designation pertains to pesticides used in or around the house by the untrained general public. The Commercial class pertains to the use in commercial activities, such as farming. The intended market segment is the key driver for the Domestic and the Commercial categories and hazard based criteria are used to ascertain that the hazard profile of a product is appropriate for the intended users. Products are placed in the Restricted class when there are potential risks that require a high level of specific protection and mitigation measures.

2.1.2 Provincial Classification Systems

Currently, pesticide classification varies across Canada. Some provinces have developed their own provincial classification systems, which in some cases includes additional categories for domestic pesticides. These provincial classification systems form the basis for implementing appropriate regulatory controls on the sale and use of domestic pesticides in their jurisdictions. Other provinces and territories rely on the federal domestic class designation without modification to regulate the sale and use of domestic pesticides.

3. Proposal for Domestic Class Pesticides

Registration of pest control products under the PCPA remains a cornerstone of ensuring that use of pesticides, including all products for use by the general public (Domestic class), is associated with acceptable risks. The federal PMRA will continue to conduct a detailed evaluation of the health, environmental impacts and value of domestic products to ensure that all registered products are acceptable for homeowner use. As an additional step, products would be classified into one of two categories. Placement into each category would be a determination based on the proposed criteria.

The classification criteria for the Domestic class currently used in the registration process will be maintained. Products meeting all the current criteria will be further divided into one of the two categories; Self-Select products (SS) and Controlled Purchase products (CP), based on formulation type (RTU vs concentrate), package size and some product specific considerations.

Self-Select products will include ready-to-use formulations, i.e., they do not require preparation of a solution or solid mix, or transfer from a container to an application device. By elimination of any mixing and handling, errors of dosing and inadvertent and unnecessary exposures are avoided. Self-Select products will also be limited to smaller package sizes (≤ 1L or 1Kg) to minimize the risks associated with storing excess product.

Certain Domestic class biopesticides will be included in the Self-Select category regardless of formulation type or container size (see Appendix 1 and glossary for bio-pesticide definition).

Certain lower risk pesticides, based on their intrinsic properties and use patterns, will be acceptable in the Self-Select category regardless of formulation type or container size (see Appendix 2 and glossary for lower risk pesticide definition).

It should be noted that with each of the above categories (biopesticides and lower risk pesticides) the Domestic class pesticide must only contain ingredients which appear in Appendix 1 or Appendix 2.

Controlled Purchase products will include those that are concentrated and require dilution; the handling of concentrates which need to be measured, diluted and mixed can result in increased exposure, and therefore higher risk. Controlled Purchase products will also include those that are marketed in larger package sizes as the likelihood of excess product and resulting storage risks is greater.

Domestic class products containing certain active ingredients, i.e., rodenticides and pesticides applied directly to water, will be classified in the Controlled Purchase category, regardless of formulation type or container size (see Appendix 3).

Classification Steps

Current Criteria for Domestic Class Products

• Acute Oral LD₅₀ > 500 mg/kg
• Acute Dermal LD₅₀ > 1000 mg/kg
• No special precautions or equipment required to mitigate inhalation hazards;
• Product and containers can be safely discarded by placing in household hazardous waste collection programs (where available) or placing empty containers in household garbage; and
• Package sizes limited to amounts that can be safely stored and used by consumers in a single season, where applicable

New Domestic class pesticides will be sorted into one of the two categories at registration, and the category will be indicated on the label. Existing registered Domestic class pesticides will be reviewed by the PMRA and assigned a Domestic class category. Registrants will be required to revise their labels of registered products when labels are updated or reprinted.

3.1 Provincial Control of Domestic Class Products

The two classification categories will provide a framework for provincial regulation of the sale and use of Domestic class products. More stringent sales requirements on Controlled Purchase products in all provinces will create a level playing field for industry.

The proposed framework provides flexibility for provinces to address their unique needs. For example, provinces may consider implementing further restrictions on Controlled Purchase and Self-Select Domestic class products (e.g. display requirements).

Individuals will also benefit from advice on Controlled Purchase products by trained staff at vendor outlets. Provinces will be able to target education efforts on the sale and use of Controlled Purchase products in a cost effective manner (e.g., Read the Label campaigns). Registrants and vendors may be interested in contributing to the development of education and vendor training programs.

3.1.1 Proposed Vendor Requirements

Trained and certified staff will be required at vendor locations selling Controlled Purchase products. These outlets may also be required to be authorized vendors or follow other provincial requirements. Trained vendor staff will be available to assist purchasers in selecting appropriate pesticides and providing information and advice on product use.

Training will be based on a new domestic vendor standard being developed by the Federal/Provincial/Territorial Working Group on Pesticide Education, Training and Certification. The standard will outline the knowledge required to sell CP domestic pesticides. Those basic knowledge requirements will include the categories of: general information, regulations, labeling, human health, pesticide safety, environment, pest management, application technology, emergency response, and professionalism.

Training curricula, which would be based on these education standards, would focus on areas of expertise required for staff dealing with the public, such as customer service and general product knowledge; providing assistance in choosing an appropriate pesticide; providing assistance in calculating pesticide applications; and providing advice on appropriate quantities for purchase and safe storage.

Domestic vendor training programs will contribute to increased public awareness of how to mitigate the risks associated with Controlled Purchase products and inform users to read and follow all label directions. Provinces will need to implement new training programs or adjust existing training programs for retail vendors selling Controlled Purchase products.

3.1.2 Proposed Exemptions

Certain types of domestic products subject to federal registration have historically been exempt from provincial training and licensing programs. Such product types include:

• swimming pool chemicals;
• wood preservatives;
• cleansers;
• sanitizers;
• disinfectants;
• laundry additives;

It is proposed that these product types continue to be exempt from provincial training and licensing/certification requirements. A detailed description of product types proposed for provincial exemption is included in Appendix 4.

4. Implementation

Recognizing the joint responsibilities of the federal and provincial governments with respect to pesticide regulation in Canada, the following roles for implementation of a harmonized domestic classification system are described.

4.1 Federal

Subsequent to the 90-day consultation period and consideration of comments received, the PMRA will publish a regulatory directive outlining the revised classification system for Domestic class products.

The PMRA will apply the criteria for the Self-Select and Controlled Purchase categories to all new Domestic class products at the time of registration. This designation would be reflected on the product label in the form of a symbol to allow for vendor management in those provinces which have the necessary sales regulations in place.

The PMRA will also apply the criteria to the approximately 1600 currently registered Domestic class pesticides based on the information on the most recent labels. Until labels can be modified by registrants, this information will be made available to provinces, vendors and registrants initially, through the use of a database to identify products as either Self-Select or Controlled Purchase. The PMRA will develop a sticker system to be used by registrants during this interim period for visual identification of products as either Self-Select or Controlled Purchase. This will allow vendor management in those provinces which have the necessary sales regulations in place.

Respecting the number of federal labelling initiatives that are currently in progress or being considered, the PMRA intends to move forward with product label changes in a coordinated manner to minimize operational impacts to registrants.

4.2 Provincial

Adoption of the harmonized classification system by provinces will need to be reflected in provincial pesticide regulations (e.g., conditions of access of consumers to those Domestic products identified as Controlled Purchase).

Provinces are currently at various stages of the regulatory process which will allow implementation at the provincial level. Prince Edward Island and Quebec for example, have a framework in place which, with minor modifications, will greatly speed implementation.

Discussions within the Federal/Provincial/Territorial (FPT) Committee on Pest Management and Pesticides reflect that a Canada-wide approach to provincial requirements on the sale and use of pesticide products, and vendor training will ultimately benefit the users of Domestic products, leading to risk reduction.

Appendices

Appendix 1

Biopesticides (microbials and biochemicals) proposed for inclusion in the Self-Select category regardless of formulation type or container size (Domestic Class Only)

• Acetic acid
• Bacillus thuringiensis Berliner ssp. Kurstaki (Btk)
• Black pepper oil
• Capsaicin
• Corn gluten meal
• Diatomaceous earth (100%)
• Dried blood
• Formic acid
• Iron (ferric) phosphate
• (S-methoprene) -when used as a topical application to pets
• Muscalure
• Piperine
• p-Menthane-3,8-diol
• Putrescent whole egg solids
• Soap
• Soybean oil

Appendix 2

Lower risk pesticides proposed for inclusion in the Self-Select category regardless of formulation type or container size (Domestic Class Only)

• (Insecticidal) Boron compounds
• Lime Sulphur
• Mineral Oil dormant/horticultural
• Sulphure - except when used on a rodenticide

Appendix 3

Active Ingredients/Pesticide Types proposed for inclusion in the Controlled Purchase category regardless of formulation type or container size

• Bacillus thuringiensis subspecies israelensis serotype H-14, strain BMP-144
• Methoprene (when applied to water)
• Rodenticides, including: brodifacoum; bromadiolone; chlorophacinone; cholecalciferol; difethialone; diphacinone; warfarin; Warfarin + ergocalciferol; warfarin + sulfaquinoxaline
• Rotenone (when used to control fleas)

Appendix 4

Pesticide Product Types Proposed for Provincial Exemption

• Swimming pool chemicals: Products applied to water in swimming pools and/or hot tubs, whirlpools and spas, to control various species of algae and harmful bacteria.
• Wood preservatives: Products applied on wood to prevent decay or damage from insects and termites.
• Cleansers or sanitizers: Products that reduce the level of microorganisms present by significant numbers.
• Disinfectants: Products that destroy or inactivate microorganisms on inanimate surfaces.
• Laundry additives: Products added for cleaning fabrics and textiles, etc.

Glossary

• Active ingredient: A component of a pest control product to which the intended effects of the product are attributed and includes a synergist but does not include a solvent, diluent, emulsifier or other component that is not primarily responsible for those effects.^*
• Biopesticide: Microbials: A microorganism (bacteria, alga, fungus, protozoan, virus, mycoplasma or rickettsia and related organisms) and any associated metabolites to which the effects of pest control are attributed. Biochemicals: A biochemical pesticide is a pest control product that:
  1. is a naturally occurring substance or structurally similar and functionally identical to a naturally occurring substance;
  2. has a history of equivalent exposure to humans and the environment demonstrating minimal toxicity or in the case of a synthetically derived biochemical pest control product, is equivalent to a naturally occurring substance that has such a history; and
  3. has a non toxic mode of action to the target pest.
  Biochemical pest control products include, but are not limited to semiochemicals (pheromones and kairomones), natural plant and insect regulators, naturally occurring repellents, attractants, and enzymes.
• Certificate: A document issued to an individual for the successful completion of an approved pesticide applicator and/or vendor certification or recertification program.
• Certification: The recognition by a regulatory agency that an individual has met or exceeded the National Standard (developed by the Pesticide Education, Training and Certification Working Group) (WGPETC) to use or sell pest control products.
• Certified Vendor or Dispenser: An individual who has obtained a certificate (authorization) for selling pesticides, which is recognized by a regulatory agency.
• CIWG: Classification Implementation Working Group established by the Federal/ Provincial/ Territorial Committee to further its collaborative work in harmonizing pesticide classification systems.
• Formulants: Any component of a pest control product that is added intentionally to the product and that is not an active ingredient.^* PMRA's Formulants Program is described in the Regulatory Directive 2004-01. PMRA considers the formulants on List 4A as being "of minimal toxicological concern"; List 4B formulants are "of minimal concern under specific conditions of use".
• FPT Committee: Federal/Provincial/Territorial (FPT) Committee on Pest Management and Pesticides, includes representatives from all provinces, territories, and the federal government and provides a forum to address issues of mutual interest or concern (e.g. The Healthy Lawns Strategy). See the FPT Committee Internet website.
• GHS: Globally Harmonized System for the classification and labelling of chemicals, including pesticides.
• Hazard: The inherent toxic potential of a pesticide, describes the nature of a risk.
• Health risk: The possibility of harm to human health resulting from exposure to or use of a pest control product, taking into account its conditions or proposed conditions of registration.^*
• Label: Anything that conveys information that is required by the PCPA or its regulations to accompany the pest control product.^*
• LD₅₀: The median lethal dose of the formulated pesticide product. The lower the LD₅₀ value of the product, the more acutely toxic the product is.
• License: A document issued by a regulatory agency authorizing an individual, entity or institution to carry on the business of selling or applying pesticides. Applicants must successfully complete training and pass a certification exam in order to be eligible to obtain this document.
• Lower risk pesticides:
  1. Criteria for consideration as lower risk pest control products
     1. Low inherent toxicity to non target organisms:
        Products with low inherent toxicity to humans and other non target organisms are expected to have minimal anticipated environmental and health risks even when exposure is extensive. Substances with chronic toxicity, carcinogenicity, mutagenicity, neurotoxicity and reproductive/ developmental effects will not be considered in the lower risk pest control product stream.
     2. Not persistent in the environment when environmental exposure is expected. PMRA recognizes that certain naturally occurring substances are relatively persistent in the environment, and therefore, a case-by case basis approach will be taken to assess this criterion.
     3. No residues of concern in target and off-target crops.
     4. Any formulants must be on List 4A or 4B. List 4A formulants do not have any restrictions of use; however, List 4B formulants have restrictions or limitations on use which also apply to proposed lower risk products. Applicants may refer to the Agency's Formulant program directive (Dir. 2004-01).
     5. Acceptable evidence to support proposed value including label claims must be available
  2. Other considerations: In addition to the above criteria, the following factors will also be considered:
     • substance available to the public for other uses;
     • long history of equivalent exposure to humans and the environment with minimal toxicity (the level of exposure should be similar to the proposed uses);
     • common food or foodstuff (mechanical processing only);
     • non-toxic mode of action (pesticidal action is not the result of target organism toxification);
     • unlikely to cause pest resistance
• National Standard: The Standard for Pesticide Education, Training and Certification in Canada (National Standard) consists of a series of documents that outline the structure and criteria for applicator and vendor certification programs in Canada. It is made up of 14 documents divided into three parts: Framework; Applicator Basic Knowledge Requirements; and Vendor/Dispenser Basic Knowledge Requirements.
• PCPA: The Pest Control Products Act is the federal legislation used to regulate products for use in Canada to control pests and the organic functions of plants and animals.
• Pest: An animal, a plant or other organism that is injurious, noxious or troublesome, whether directly or indirectly, and an injurious, noxious or troublesome condition or organic function of an animal, a plant or other organism.^*
• Pest control product: A product, an organism or a substance, including a product, an organism or a substance derived through biotechnology, that consists of its active ingredient, formulants and contaminants, and that is manufactured, represented, distributed or used as a means for directly or indirectly controlling, destroying, attracting or repelling a pest or for mitigating or preventing its injurious, noxious or troublesome effects; an active ingredient that is used to manufacture anything described previously; or any other thing that is prescribed to be a pesticide or pest control product.^*
• Pesticide: Equivalent to a pest control product.
• PMRA: The Pest Management Regulatory Agency, under Health Canada, is the federal agency that assesses and registers all pesticide products for sale and use in Canada.
• Value: A product's actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration, and includes the product's:
  1. efficacy;
  2. effect on host organisms in connection with which it is intended to be used; and
  3. health, safety and environmental benefits and social and economic impact.^*
• Vendor: An individual, entity or institution authorized to conduct the business of selling pesticides under the terms and conditions stipulated by a licence.
• WGPETC: Pesticide Education, Training and Certification Working Group of the Federal/Provincial/Territorial Committee on Pest Management and Pesticides, is comprised of federal, provincial and territorial representatives involved in pesticide regulation or education as well as representatives from the United States. The WGPETC's mandate includes the promotion and development of harmonized pesticide education, training and certification standards across Canada.

^* PCPA definition/interpretation