Regulatory Proposal PRO2018-03, Pre-Consultation – Proposed Amendments to the Pest Control Products Regulations (Product Exemptions) - Summary

Pest Management Regulatory Agency
30 November 2018
ISSN: 1925-122X (PDF version)
Catalogue number: H113-8/2018-3E-PDF (PDF version)

Summary

Table of Contents

• Executive Summary
• 1.0 Background and issues
• 2.0 Scheduled pool and spa products
  • 2.1 Proposed changes for pool and spa products
  • 2.2 Update regulations due to recent re-evaluation decisions
  • 2.3 Updating regulations to better reflect current practices
  • 2.4 Use of lithium hypochlorite in swimming pools
  • 2.5 New candidates for Schedule 2
• 3.0 Other measures being considered
  • 3.1 Chlorine for zebra and quagga mussel control
  • 3.2 Treated articles
  • 3.3 Foods used as pest control products
• 4.0 Input requested

Executive Summary

In Canada, pesticides are regulated under the Pest Control Products Act and its associated regulations, including the Pest Control Product Regulations. While most pesticides must be registered under the Pest Control Products Act to be used in Canada, section 3 of the Pest Control Products Regulations describes a group of products that are exempt from the Pest Control Products Act and section 4 describes a limited group of product types that are exempt from registration. Products that are exempt from registration are still subject to regulation, including routine compliance and inspection programs.

Health Canada's Pest Management Regulatory Agency (PMRA) is reviewing the current regulatory framework for products currently exempt from registration and those exempt from the Pest Control Products Act in order to identify policy, program or regulatory improvements.

Exempting products from registration allows a reduction in administrative burden for both industry and government and still provides an appropriate level of regulatory oversight of products for which there is considerable knowledge and regulatory experience in Canada. However, this places greater responsibility on industry to ensure that marketed products meet certain prescribed conditions.

This document identifies measures under consideration for products of lower or well characterized risk that have a long history of safe use in Canada. The proposal would further reduce administrative costs for government and industry while maintaining appropriate health and environmental protections and include the following:

• Expanded ranges of active ingredient concentrations listed in Schedule 2 for pool and spa products. (See Appendix I of PRO2018-03 for a summary of the proposed changes to Schedule 2 pool and spa products);
• Pool and spa products listed in Schedule 2 would be limited to repacks of the active ingredients with the exception under consideration being for pool and spa tablets and for a new proposed spa use of sodium bromide (activated by sodium dichloro-s-triazinetrione);
• End-use pool and spa products in Schedule 2 would be limited to domestic class products only; commercial class products will remain subject to registration under the Pest Control Products Act;
• Antimicrobial preservative treated articles are proposed to be exempt from registration with conditions;
• Allowing the use of chlorine for zebra and quagga mussel control with conditions;
• Exempting nitrogen stabilizers that act on soil bacteria from the Pest Control Products Act (they will continue to be regulated by the Canadian Food Inspection Agency); and
• Foods used as pest control products are proposed to be exempt from registration.

1.0 Background and issues

The Minister of Health's primary objective under the Pest Control Products Act is to prevent unacceptable risks to human health and safety and the environment from the use of pest control products. To meet this objective, the Pest Control Products Act requires the Minister of Health to conduct pre-market assessments of pest control products to determine if the risks to health or the environment are acceptable and the products have value.

Health Canada is conducting a comprehensive review of the Pest Control Product Regulations to:

• Ensure the Pest Control Product Regulations continue to meet program objectives, while minimizing administrative burden on regulated parties and government;
• Ensure alignment between the regulations and operational policies and procedures; and
• Recommend policy, program or regulatory amendments, as required.

2.0 Scheduled pool and spa products

In the mid-1980s, eight active ingredients used in the manufacture of swimming pool and spa sanitizers were added to Schedule 2 of the Pest Control Product Regulations. Manufactured pool and spa end-use products that use these scheduled active ingredients and meet the terms and conditions in Schedule 2 can be sold and used in Canada without registration but are subject to routine sampling and enforcement programs, as well as re-evaluation. It was estimated at the time that approximately 500 selected domestic class products that were registered for the control of bacteria and/or algae in residential swimming pools and spas were exempted from registration.

Table 1 List of the active ingredients currently listed in Schedule 2 for pool and spa products

Active ingredient	Use	Concentration (%)	Available chlorine (%)
Sodium hypochlorite	Pool	10.8	10.3
Calcium hypochlorite	Pool	65 or 70	65 or 70
Lithium hypochlorite	Pool/Spa	29	35
Trichloro-s-triazinetrione	Pool	100	90
Sodium dichloro-s-triazinetrione	Pool/Spa	100	62
Sodium dichloro-s- triazinetrione dihydrate	Pool/Spa	100	56
Sodium bromide	Spa	35	Not applicable
Potassium monopersulfate	Spa	32	Not applicable

Guidance on the scheduled pool and spa products and the applicable conditions are contained in the Regulatory Directive DIR93-05. However, certain policies outlined in this Directive are not reflected in the Pest Control Product Regulations. For example, the Directive states that:

• Scheduled pool and spa products must be re-packs of the registered active ingredients and must not contain any formulants, and
• Scheduled pool and spa products are restricted to Domestic class products only

Based on preliminary discussions with some pool and spa companies and internal discussions with Health Canada Regional Compliance and Enforcement Officers, Health Canada reviewed issues with the current Schedule and explored options for updating the existing regulations to reflect current practices while using this opportunity to further reduce regulatory burden, and maintain health and environmental protections. Several candidates for addition to Schedule 2 were also considered. The outcome of the review and proposed amendments to Schedule 2 are outlined below.

2.1 Proposed changes for pool and spa products

The following amendments to Schedule 2 are proposed to align the regulations with operational policy:

2.1.1

Formulants/additives in Pool and Spa products: Clarify in regulations that formulants are not permitted in scheduled pool/spa products, which are limited to repacks of the active ingredients only. Products that contain concentrations, mixtures or active ingredients other than those listed in the schedule will be subject to the registration process.

Two exceptions are being considered: formulants used in the manufacture of chlorinating tablets as discussed in 2.3.2 below; and dual sodium bromide and sodium dichloro-s-triazinetrione products.

2.1.2

Class of products: The scheduled product must be represented or sold as a domestic class swimming pool or spa product to control bacteria and/or algae. Commercial class/category products will be subject to the registration process.

2.1.3

Formulation types: Currently the Regulatory Directive DIR93-05 identifies which formulation types (for example, solution, granule, tablet) are permitted in end-use products; however, the regulations do not reflect this policy. The proposal would amend the regulations to clarify which formulation types are authorized.

2.1.4

All sources of the active ingredient used in the product must be registered under the Pest Control Products Act.

2.1.5

Appropriate contents, use instructions, limitations, precautionary statements and hazard symbols must appear on the product label.

Model Labels for Pool and Spa Chemicals (Appendix II of PRO2018-03) are provided to assist registrants in preparing compliant labels. For the use and concentration of active ingredients described in this schedule, the registrant can use the Model Labels by inserting their company's relevant information (for example, address, brand designation). Scheduled product labels must incorporate all information from the Model Labels.

2.1.6

Prescribed limitations on the concentration of registered active ingredient and the amount of available chlorine/bromide, as applicable, must be followed.

2.2 Update regulations due to recent re-evaluation decisions

As a result of the recent regulatory decision from the re-evaluation of pool/spa active ingredients, the following amendments to Schedule 2 are being proposed.

2.2.1

Sodium bromide for spa uses: The 2018 re-evaluation decision for sodium bromide (RVD2018-36) indicated that health risks were not found to be acceptable for the currently scheduled spa uses for sodium bromide activated with potassium monopersulfate. Therefore, this use is proposed for removal from Schedule 2. Based on comments received during the public consultation period, the PMRA proposes to schedule a different spa use for sodium bromide that is applied at a lower rate and in combination with a different activator (sodium dichloro-s-triazinetrione, which is already on Schedule 2). This amendment would align with the use pattern for registered sodium bromide end-use products. This scheduled use is proposed as a single product composed only of registered sodium bromide and sodium dichloro-s-triazinetrione technical grade active ingredients. Please see Model Label in Appendix II of PRO2018-03 for details on the permitted ratios of these two active ingredients.

2.2.2

Label Updates: Updates to the Model Labels in Appendix II of PRO2018-03 are being proposed to reflect changes resulting from the re-evaluations. These updates include changes to hazard symbols and updated statements regarding precautions, first aid, toxicological and use instructions.

2.3 Updating regulations to better reflect current practices

The following proposed amendments to Schedule 2 will update the Pest Control Product Regulations to reflect current practices and incorporate recent decisions made from re-evaluations.

2.3.1

Expanded range of active ingredient concentrations

For each of the pool and spa active ingredients listed in Schedule 2, an analysis of currently registered products and their respective use patterns was undertaken to explore whether there were opportunities to expand the concentration range. As a result of this analysis, the PMRA is proposing to expand the range of active ingredient concentrations to be used in scheduled products. The sources of registered active ingredients currently available to manufacturers of pool sanitizers come in a range of concentrations and the current schedule precludes many of these sources from being used to manufacture scheduled end-use products. Establishing a range of concentrations for scheduled active ingredients (for example, calcium hypochlorite at 65-75 %) would reduce the administrative burden for industry and government without compromising the regulatory oversight required for these products. It would allow manufacturers to choose among alternative registered sources based on cost/availability while still meeting the conditions in Schedule 2 for these products.

The PMRA is proposing the following updates to Schedule 2 pool and spa products:

Table 2 Proposed updates to Schedule 2 pool and spa products

	Current Schedule	Proposed Schedule
Active Ingredient	Available Chlorine (%)	Available Chlorine (%)
Sodium hypochlorite	10.3	10-11
Calcium hypochlorite	65 or 70	65-75
Trichloro-s-triazinetrione	90	90-91
Sodium dichloro-s-triazinetrione including anhydrous and dihydrate	56 (dihydrate) and 62 (anhydrous)	55-62 (either form)

Registrants of these active ingredients will be requested to inform clients of the new conditions, which will be set out in Schedule 2 of the regulations once updated.

2.3.2

Use of additives/formulants in the manufacture of pool and spa tablets

During the analysis of the currently scheduled pool tablets, it was noted that certain formulants or additives are used in the manufacturing of some trichloro-s-triazinetrione and sodium dichloro-s-triazinetrione pool/spa tablets (molding agents, flowing agents, etc.).

The PMRA is seeking input from manufacturers via this consultation document on what additives/formulants are used in the manufacture of these tablets. The PMRA will consider permitting the use of certain formulants in scheduled trichloro-s-triazinetrione and sodium dichloro-s-triazinetrione tablets under specific conditions provided the risks are acceptable. This would allow the use of these formulants in the manufacture of tablets that use scheduled active ingredients.

2.3.3

Expand formulation types and uses

For each of the pool and spa active ingredients listed in Schedule 2, an analysis of currently registered end-use products and their respective use patterns was undertaken to explore whether there were opportunities to expand the formulation types (for example, granules or tablets) and uses (for example, pool or spa).

As a result, the PMRA is proposing to:

2.3.3.1

Add tablet formulations of sodium dichloro-s-triazinetrione to Schedule 2

According to the Regulatory Directive DIR93-05, scheduled sodium dichloro-s-triazinetrione products (including anhydrous and dihydrate forms) are permitted as a soluble granule formulation only. This amendment would allow the use of soluble granule and tablet formulations.

2.3.3.2

Expand the scheduled use of trichloro-s-triazinetrione to include spas.

Currently, scheduled trichloro-s-triazinetrione products are permitted to be used in pools only. This amendment would allow the use of scheduled trichloro-s-triazinetrione products in spas as well.

2.4 Use of lithium hypochlorite in swimming pools

There are currently no registered end-use products containing lithium hypochlorite in Canada; however, there may be scheduled end-use products available on the market. Re-evaluation of lithium hypochlorite is scheduled for initiation in 2020. As part of the re-evaluation process registrants are required to confirm their support for the continued registration of their product, and to provide a list of existing studies, as well as any studies that may be underway. At this time, Health Canada is seeking input on manufacturers' support for continued scheduling of lithium hypochlorite pool products and the extent of lithium hypochlorite use in pools and spas in Canada.

2.5 New candidates for Schedule 2

An analysis of registered end-use products for pool and spa uses was undertaken in order to identify potential new candidates for addition to Schedule 2. The PMRA determined that the product would need to meet several criteria, including the following: the product must not contain formulants (in other words, it must be a technical re-pack); it must not be combined with another active ingredient; and, there are no additional data that require review.

Several active ingredients representing 400 registered pool and spa end-use products were considered. However, upon final analysis it was determined that none of the products reviewed satisfied all of the criteria at this time.

3.0 Other measures being considered

In addition to the changes being proposed for pool and spa products, Health Canada is proposing the following amendments to Schedule 2 to exempt the following products from registration:

3.1 Chlorine for zebra and quagga mussel control

Zebra and quagga mussels are invasive species that, if left unchecked, can pose severe threats and economic impacts on waterways and native species. Chlorine has been used to prevent the buildup of zebra and quagga mussels in intake pipes in Ontario, both for potable and for industrial process water since 1992, through the Note to the Canadian Association of Pest Control Officials C92-03. The PMRA is proposing that this use be made available to other provinces as the zebra and quagga mussel problem spreads.

The proposed amendment would include the use of chlorine to control zebra and quagga mussels in Schedule 2 of the regulations consistent with the conditions permitted in C92-03. This includes use rates that are consistent with potable water treatment (in other words, 0.4-2.0 ppm free available chlorine) and a requirement that effluent/return water must meet traditionally recognized and accepted environmental and water quality objectives.

3.2 Treated articles

The term "treated article" is used to refer to any product that has been treated with a pesticide. This includes articles treated with antimicrobial preservatives (for example, textile treated with a material preservative), insecticides (for example, insecticide-treated clothing), and herbicides (for example, herbicide-treated landscape fabric). A pesticide that has been incorporated into or applied to an article during manufacture for import, sale or use in Canada must be registered under the Pest Control Products Act.

Antimicrobial material preservatives are commonly used in Canada, as well as in other countries, to extend the durability or shelf-life of the treated product or material. Examples of products that may contain antimicrobial material preservatives include: water-based paints; certain plastic products, such as shower curtains; and wood and construction/masonry materials.

Articles treated with antimicrobial material preservatives are proposed to be exempt from registration under the following conditions:

• The antimicrobial preservative used to treat the article is registered under the Pest Control Products Act;
• The use is limited to preventing degradation or damage to the product from microorganisms;
• The article is treated in accordance with the approved use pattern of the registered antimicrobial preservative (in other words, use and application rates);
• Any claims associated with the article must be consistent with those approved for the antimicrobial preservative use for treatment (in other words, limited to the preservation of the article itself); and
• The antimicrobial preservative used for treatment must not contain a formulant or contaminant of concern, or a preservative as a formulant that is not registered under the Pest Control Products Act.

3.3 Foods used as pest control products

Health Canada's regulatory review of the Pest Control Product Regulations provided an opportunity to investigate options for exempting certain non-conventional chemicals from registration, including certain food items of interest to the organic agriculture sector. In consultation with the Organic Value Chain Roundtable, which represents organic growers in Canada, Health Canada is proposing to exempt from registration, certain food products that are used to control pests on food crops.

Extracts and essences of edible plants and botanicals, including essential oils are not acceptable under this proposal, as there are too many factors that must be considered to make general presumptions of safety (for example, different sources/species, different methods of processing, differences in types and levels of contaminants of concern such as methyl eugenol).

The list of candidate foods submitted by Organic Value Chain Roundtable were reviewed and grouped into two categories:

• Foods with low/no risks of concern
• Foods that are identified by Health Canada as priority allergens

3.3.1 Foods with low/no risks of concern may include:

• Baking soda
• Beer
• Canola oil
• Cayenne pepper
• Chili powder
• Cinnamon (powder and stick)
• Citrus juice
• Cooking oil (vegetable)
• Corn meal
• Cornstarch
• Garlic (whole plant, powder, minced, granulated, chopped, and juice)
• Horseradish
• Mint tea
• Potato
• Rosemary (fresh and dried)
• Salt (table)
• Sugar
• Vinegar (table and pickling)

In order to qualify for the exemption, the products would need to meet the following conditions:

1. Be free of any poisonous or harmful substances.
2. Be fit for human consumption.
3. Be free in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance.
4. Be unadulterated (as per subsection 4(2) of the Food and Drugs Act, by reason only that it has in or on it a pest control product as defined in subsection 2(1) of the Pest Control Products Act, or any of its components or derivatives, if the amount of the pest control product or the components or derivatives in or on food being sold does not exceed the maximum residue limit specified under section 9 or 10 of the Pest Control Products Act) or, if no maximum residue limit is specified, the amount of the pest control product, its components or derivatives does not exceed 0.1 ppm.
5. Have been manufactured, prepared, preserved, packaged or stored under sanitary conditions.
6. Be free of further manufacturing (formulated pest control products must be registered under the Pest Control Products Act).
7. Have a low inherent toxicity to non-target organisms.
8. Are not persistent in the environment.
9. Are unlikely to select for pest resistance.

3.3.2

Foods identified as priority allergens proposed for use as pest control products:

• Bran (wheat)
• Eggs (whole and dried)
• Flour (wheat)
• Milk (fresh and powdered)
• Mustard (meal)
• Soybean oil
• Wine (may contain sulphites)

Foods used as pest control products on food crops, which are also food/priority allergens are permitted when used under the following conditions. These conditions are intended to prevent direct application of the pest control product to harvestable/edible portions of the crop:

1. Use in nursery and greenhouse operations, which includes seeding, potting and transplanting activities.
2. Incorporation into seedling and planting beds.
3. Applications to the field that occur after the harvested crop has been removed.
4. Soil-directed applications around and adjacent to all plants.
5. Aerial and ground applications that occur when no above-ground harvestable food commodities are present (usually pre-bloom).
6. Applications to the same crop from which the food commodity is derived, whether the plant fraction(s) intended for harvest are present or not (for example, applications of peanut meal to peanut plants).

3.3.3

Nitrogen stabilizers

Nitrogen stabilizers are applied with many forms of nitrogen-based fertilizers. These products can be impregnated or coated onto dry fertilizers, mixed into solutions of liquid fertilizers, co-applied with anhydrous ammonia, or can be blended with liquid manure prior to application into the soil. Nitrogen stabilizers are used to increase nitrogen-use efficiency by reducing losses through volatilization, leaching, runoff, denitrification, etc., allowing for more of the applied nitrogen fertilizer to be used by the crop.

Nitrogen stabilizers that act on soil bacteria meet the definitions of a "pest control product" under the Pest Control Products Act and as a "supplement" under the Fertilizers Act. This regulatory duplication has created confusion. To eliminate this duplication, Health Canada and the Canadian Food Inspection Agency have agreed that the Canadian Food Inspection Agency would be responsible for regulating these products in Canada; therefore, Health Canada is proposing that nitrogen stabilizers that act on soil bacteria be exempt from the Pest Control Products Act.

This amendment would eliminate this regulatory duplication and provide industry with a single consistent regulatory approach for these products. Health Canada is satisfied that the scientific risk assessments conducted by Canadian Food Inspection Agency adequately address the health and environmental risks, and value associated with these products.

4.0 Input requested

Health Canada's PMRA is seeking input from interested Canadians on the measures set out in this document to update Schedule 2 of the Pest Control Product Regulations. All interested Canadians are invited to submit their views.

Health Canada will consider all comments received before finalizing the proposal in preparation for formal consultation in the Canada Gazette, Part I. Please provide your comments and include the following information: your full name and organization, telephone number, and complete mailing address or email address.

Written comments on this proposal will be accepted up to 90 days from the date of publication. Please forward all comments to PMRA Publications.