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Value Guidelines for New Antimicrobial Pest Control Products and Label Amendments

(PDF Version - 547 K)

Pest Management Regulatory Agency
14 April 2016

Table of Contents

1.0 Background

The purpose of this document is to outline the general principles of pesticide value assessments in Canada. This document describes the types of information that could be provided to register new antimicrobial products and to support label amendments, and provides guidance on summarizing value information prior to submission to the Pest Management Regulatory Agency (PMRA). In this document, the denomination "antimicrobial" refers to products used for the control of microorganisms (bacteria, fungi, algae, protozoa or viruses) and other fouling organisms (such as zebra mussels or barnacles) on or in inanimate objects, industrial processes, water or air. For the purpose of these guidelines, an antimicrobial product can also include devicesFootnote 1. Information provided in this document does not apply to agricultural pesticides. For guidance on agricultural products, the Value Guidelines for New Plant Protection Products and Label Amendments should be used.

This document replaces T-1-215: Efficacy Data for Antimicrobial Products (issued 31 October 1980) and incorporates information presented in Regulatory Directive DIR2013-03, Value Assessment of Pest Control Products. The information in this document reflects the current approach that PMRA is implementing for the value assessment of pesticides.

The value of a pest control product, as defined by the Pest Control Products Act (PCPA), refers to the product's actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration. This includes the product's efficacy, health, safety and environmental benefits, and social and economic impact. The value assessment is an evaluation of these various components and provides the baseline for health and environmental risk assessments and risk management decision making. In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value.

Previously, the PMRA relied primarily on efficacy data to establish the value of proposed uses of pesticides. The current approach is based on the weight of evidence from both efficacy and benefits information. It can include information on various components, which includes experimental data generated from research trials, use history information from other jurisdictions, existing scientific literature, scientific rationales and benefit information. The PMRA's approach to value assessments was developed in consultation with stakeholders and in consideration of approaches by other regulatory agencies. The consideration of the definition of value as stated in the PCPA provides flexibility in fulfilling information requirements that will help reduce the regulatory burden for applicants. It will also provide opportunities for alignment with Organisation for Economic Co-operation and Development (OECD) countries and increase efficiency of the value assessment process.

This document is meant to serve as a general guideline and should be interpreted as such. As the specific details regarding the use of an antimicrobial pest control product can vary significantly from one situation to the next, there is a need for flexibility in interpretation and application of the guidance with regards to the manner in which value requirements can be addressed. The guidelines in this document are primarily for applications to register pesticide products based on new or registered active ingredients and to amend the labels of currently registered pesticide products.

2.0 General Principles and Considerations of Value Assessments

Value assessments consider the benefits of the proposed use, determine whether the product is likely to provide acceptable efficacy when used according to label directions and establish the use pattern that serves as the basis for the risk assessment.

Value assessments are based on sound science, and a weight of evidence approach is used in formulating conclusions. Applicants have flexibility in addressing information needed for the value assessment. Information could be provided in the form of use history, results of research trials, published information or scientific rationales. Various types of benefit information may be provided, as appropriate, to provide context about the proposed use. This can include social and economic impacts, survey of alternatives, health, safety or environmental benefits.

2.1 Consideration of Benefits

Insight into the actual or potential benefits associated with the availability of a new use or new product is an integral component of the value assessment. Information should be provided to show how and to what extent its registration would benefit Canadian users. The components of benefit information include elements such as a survey of alternatives (for example, known advantages or disadvantages over currently registered products), social or economic impacts (such as paper mill downtime), and health, safety and environmental benefits. The projected benefits of the proposed use should be described in relation to the pest problem. Quantitative estimates are preferable, although qualitative information is also useful.

2.2 Efficacy

Different types of information may be used to demonstrate efficacy, including use history information, published papers, scientific rationales and trial data. Further guidance for each of these information sources is provided below. The value information package may include one or a combination of these types of information.

2.2.1 Use History Information

Use history information consists of a record of the performance of a pest control product in anotherFootnote 2 country for the same use as the one proposed in Canada. The information may be supplied by applicants to support efficacy claims for the registration of a new product or new use and should include quantitative information when possible.

Use history information may be particularly useful when the proposed use is currently registered and adopted in an OECD country; there is little or no efficacy data available to support the use: or a scientific rationale is not appropriate to support the proposed use.

For applications involving unregistered active ingredients, or major new uses of registered active ingredients with a history of use in other countries, use history information could supplement, reduce or replace efficacy data. This is possible because a product's record of performance is included in the use history information that should be submitted by applicants.

To compare the Canadian-proposed and foreign-registered use patterns, the applicant should do the following:

  • Provide the foreign label.
  • Compare all use pattern parameters between the two labels and explain any differences.
  • If applicable, state any currently registered Canadian uses that may be useful for extrapolation purposes (such as a pest in a different site or different pests in the same site).

A description of the performance and experience associated with the pest control product registered in the foreign jurisdiction is needed to enable a determination to be made regarding the efficacy of the proposed use. The applicant should do the following:

  • Describe the relevant use pattern of the product and the factors that may affect performance.
  • Provide an insight into the level of control provided by the product on its own and relative to no control and/or registered alternatives.
  • State whether the product meets commercial expectations.
  • Describe the level of adoption of the product by the users in the industry.

Details related to use history should be provided by experts who are familiar with the product, its performance under commercial conditions, and the factors that can affect its performance. When use history information is provided by an individual who does not have direct experience with the proposed use, the validation statement should be included.

2.2.2 Published Papers

Published scientific papers may be used to address efficacy. Applicants should clearly indicate how the information in the paper relates to the proposed uses, and include a copy of the article in the value information package.

2.2.3 Scientific Rationales

Arguments based on established scientific principles and precedent registrations can be used to address efficacy. When a rationale is provided, the scientific basis on which it relies, as well as specific details related to the precedent registrations should be clearly indicated. Any documentation cited in the scientific rationale should be submitted to PMRA.

2.2.4 Efficacy Trials

It is recognized that use history information, published papers and/or scientific rationales may not always be available to support a proposed product or use, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates. Note that Section 6.0 Guidance Specific to Each Use-Site Category contains specific information on the efficacy trials usually required for various use-site categories. Also, the information that follows should be considered when conducting efficacy trials.

2.2.4.1 Pest Problem and Experimental Design

Antimicrobials are used to address a wide range of problems associated with microorganisms. For example, biofilm in cooling towers can reduce water flow, impede heat transfer and cause increased corrosion to equipment. When designing trials to generate efficacy data in support of a particular use, it is important to ensure that the trial is relevant and representative of the proposed use, is scientifically valid, and that the results are presented in a manner that can clearly show whether or not the product works as intended. The challenge microorganisms (the bacteria, yeast, mold, algae, etc.) used in the efficacy tests should be the ones associated with the pest problem. It is equally important that the study takes into account the growth conditions (such as temperatures and organic load) under which a specific pest problem occurs.

2.2.4.2 Accelerated Testing

Some antimicrobials are expected to protect the treated product for many years. As it could be impractical to wait many years to obtain meaningful data from these long-term studies, accelerated test methods may be an acceptable alternative (wood preservatives, material preservatives, etc.). Applicants who wish to conduct accelerated testing are strongly encouraged to contact the PMRA for a review of the proposed protocol prior to conducting the study. The protocol should include the proposed minimum amount of time required for the trial. A written explanation of how the trial results will relate to an expected duration or period of control under actual use conditions should also be provided. Depending on the circumstances, it may be necessary to conduct real-time testing in parallel with the accelerated studies. Use history information can also be submitted to provide information on the long-term performance of the product if it is already registered in another country (see Section 2.2.1 Use History Information).

2.2.4.3 Performance Standards

Performance standards are usually quantitative statements that establish an acceptable level of control of a pest, but may be measured in many different ways depending on the intended use of a product. For certain products, the evaluation of success is a combination of qualitative and quantitative units, reflecting expected practical and scientific results (does it work, at what concentration, to what degree, for how long, etc.). Performance standards can be influenced by the user's expectations or requirements for control, and may not necessarily be directly related to a level of reduction of targeted pests. For example, the performance of a material preservative may be measured in terms of the increased duration of protection of the material. The performance may also be determined by monitoring/measuring the pest problem and the resulting secondary effects (for example, the amount of biofilm). Applicants are requested to explain why a particular performance standard is appropriate based on the use of the product.

2.2.4.4 Adjuvants

The purpose of adjuvant products is to improve the efficacy of the antimicrobial product that it is mixed with (such as dispersants used with slimicides). Efficacy testing should be carried out using the adjuvant at the proposed range of rates. Trials should compare results from the use of the antimicrobial with the adjuvant against results from:

  • the use of the antimicrobial alone
  • an untreated control
  • a control with the adjuvant alone

2.2.4.5 Use of Neutralizers

In trials where the test organisms are taken from the treated samples for further analysis, such as a plate count following a bactericidal treatment, appropriate neutralizers should be used to inactivate the active ingredient. Evidence supporting the effectiveness of the neutralizer against the active ingredient and showing that the neutralizer itself does not have antimicrobial activity should be included in the report. When a neutralizer is not used or not available, the applicant should explain why and provide evidence that appropriate precautions have been taken in order to ensure that there are no residual effects of the active ingredient in the assay medium.

3.0 Label

As the data requirements for a value review are based on the proposed label claims, the directions for use should be clear and relevant, and the claims scientifically supported. The directions for use should contain all the necessary information for the proper use of the antimicrobial product, including the site, method, rate and frequency of application relating to each proposed use. The site or material to be treated and the purpose of the treatment should be clearly identified (for example, "in-can latex paint preservative", instead of "paint preservative"). Optional label claims and lists using wording like "such as" and "etc." are generally not acceptable (unless the entire group is accepted, for example, synthetic fabrics such as polyester).

The following information is generally required on a label:

  • Type of antimicrobial pesticide (antifouling paint, heavy-duty wood preservative, slimicide, etc.).
  • Spectrum of biological activityFootnote 3 (bactericide, fungicide, algaecide, etc.).
  • Type of control (prevents fouling versus removes established fouling, etc.).
  • Type of protection provided (prevents degradation, odour, fouling, discoloration, etc.).
  • Area of use, site of application and surface type or material to be treated. For material preservatives, the identification of specific end-uses (caulking, interior latex paint, exterior latex paint, stucco, etc.)Footnote 4.
  • Duration of treatment and/or protection, frequency of treatment and any specific interval between applications (if applicable).
  • Any limitation of use (for example, not for use on aluminum hulls).
  • Directions for use, including method and application rates or residual concentration to be maintained, target retention (kg/m3) or target deposition (μg/cm2), expected coverage (m2 per litre of paint), the contact time, dilution and rinse if applicable. When pesticide rates are given as a range, instructions may be required as to when to use the lower and higher application rates.
  • Any other information pertinent to the efficacy of the antimicrobial (pre-cleaning, surface preparation, use limitations, etc.).
  • For preservatives to be used in the manufacture of treated articles5, a list of the specific articles manufactured from the treated materials (such as vinyl liners) should appear on the label.
  • For swimming pool and spa sanitizers, it is recommended to use the Health Canada model labels outlined in Regulatory Directives DIR93-05 and DIR93-06 as templates. For devices, more information on label requirements is available in Appendix I.
  • For swimming pool algaecides, the identification of sanitizing products with which the algaecide is incompatible as well as the following statement for copper based algaecides must appear on the label: "Warning: Staining of pool surfaces may occur due to deposit of copper salts. Excessive levels of copper will increase the probability of this occurrence."
  • In cases where a commercial class sanitizer is used only for non-food contact surfaces, the following sentence should be added to the label "Not for use where food is manufactured, prepared or kept for sale."
  • For heavy duty wood preservatives, unless supported by long-term ground contact Canadian field studies, relevant use history, or scientifically valid rationales, the following statement must appear on the label: "Do not use to treat wood used in critical infrastructures such as utility poles, pilings, railway ties, etc."

4.0 Preparation and Reporting of the Value Package

4.1 Pre-submission Consultations

A pre-submission consultation provides regulatory advice prior to the submission of an application to register or amend a pest control product. The intended outcome of the process is to provide guidance on a study protocol and/or provide advice on how to develop a complete and concise information package that addresses all of the proposed label claims. It is recommended that the applicant allow time for additional research, if required, following the pre-submission consultation in order to take into consideration any comments or recommendations from the PMRA.

4.2 Research Authorizations

Under certain conditions (such as operational trials), a research authorization issued by the PMRA may be required to conduct research with an unregistered product in Canada.

4.3 Bridging Information

Bridging information may be provided in cases where a proposed new use is directly comparable to either a use that is already included in the registration of another pest control product, or another proposed use that is supported by sufficient information. Comparative (side-by-side) bridging trials can then be used to demonstrate that product performance is equivalent between the original product or use, and the proposed new product or use. Furthermore, in some cases, claims for new formulations of pesticides, and label amendments to add a new pest or site may require only bridging information rather than the comprehensive information required for the evaluation of a new active ingredient or major new use. Bridging information should be supported by a scientifically based rationale explaining how the existing data can support this new use.

4.4 Additional Considerations

Information and studies submitted as part of the value package should be based on sound scientific principles carried out or commissioned by the applicant. Scientific judgment should always be exercised in conducting research and evaluating the results. Registrants should consult with scientific authorities familiar with the area of research, and refer to suggested protocols, current published literature, and biological and statistical reference texts for more specific information on experimental design and procedures. When conducting efficacy studies, the following additional information should be considered:

  • The objectives of efficacy studies are to ensure that there is a benefit to the proposed uses, and that the product works as claimed at rates that are appropriate, but not excessive.
  • The formulation used in efficacy trials should be identical to the formulation for which registration is sought, otherwise bridging data or a scientific rationale should be provided.
  • When applicable, the label rates should be in accordance with the measurement units used in the efficacy trials, or a conversion method and description of the calculation should be provided.

5.0 Structure of the Value Package for Antimicrobial Products

Guidance regarding the general organization and formatting of a submission is presented in Regulatory Directive DIR2003-01, Organizing and Formatting a Complete Submission for Pest Control Products. Value information should be submitted under Part 10 and organized using the various data codes (DACOs). Note that the DACOs that need to be addressed will vary with the nature of the proposed use(s) and that some types of information, such as a benefits analysis or use history, may apply to several DACOs.

6.0 Guidance Specific to Each Use-Site Category

The type of information that can be provided for the value assessment can include one or a combination of the following: experimental data generated from research trials, use history information from other jurisdictions, rationales based on accepted scientific principles, existing scientific literature, and benefits information.

This section lists the most common antimicrobial testing methods to use if research trials are to be carried out to generate efficacy data, classified by use-site category (USC). Note that suggested protocols are not strict requirements and alternative testing protocols may be used as long as they are scientifically valid and representative of the proposed uses. Specific label guidance follows.

6.1 USC 1 (Aquaculture and Aquatic Food Sites)

USC 1 includes a variety of pest control products. The following guidance is given with respect to products controlling fouling in aquaculture settings (for example, net and pen coatings, impregnation agents or coatings for ropes and cages/traps). Refer to the Value Guidelines for New Plant Protection Products and Label Amendments document for information on how to address value for other aquaculture pesticides.

DACO PART 10 - Value

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (specifically, use history information, published papers, scientific rationales and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance that follows.

Efficacy: Laboratory Trials

Laboratory trials are useful to determine the most appropriate rates of the pesticide to be tested in small-scale/operational trials. They could be submitted if already available, but are not typically required for this type of product. Laboratory trials usually meet the following criteria: artificial introduction of the pest using representative fouling organisms (barnacles, macroscopic algae, etc.). Trials should include untreated controls and demonstrate that the antimicrobial is able to prevent fouling. Pesticides can be applied to part of, or a sample of, a net or cage. A scientifically valid number of replicates should be included in the trial for each treatment tested.

Efficacy: Small-Scale/Operational Trials

Small-scale and/or operational trials should be carried out in a marine and/or freshwater environment, where the fouling of aquaculture netting or cages are known to pose a problem. The proposed product should be applied to the actual materials that are to be treated (net, cage, etc.) as per the label directions. The trial should also include an untreated control in order to demonstrate an adequate pest pressure. Fouling organisms should be identified by type (algae, molluscs, etc.) and quantified in terms of percentage surface coverage or weight. The submitted trial should include the results, a thorough description of how the trial was conducted and include relevant details such as location of the study, water conditions (temperature, salinity, flow rate, etc.) and meteorological parameters. A scientifically valid number of replicates should be included in the trial and clear acceptable performance standards should be identified and justified (for example, percentage surface coverage and/or percentage reduction of water flow deemed acceptable or a failure). Trials should also consider a comparison with the performance of a currently registered product. If the trials are conducted outside of Canada, a scientific rationale should be submitted to explain how the submitted efficacy trials can be used to support Canadian uses. In certain cases, photographic evidence can be provided as additional information.

6.2 USC 2 (Aquatic Non-food Sites)

USC 2 includes a variety of pest control products. The following guidance is given with respect to products applied to various bodies of water to control algae, bacteria, mussels or other microorganisms (lakes, ponds, sewage, etc.). Refer to the Value Guidelines for New Plant Protection Products and Label Amendments for information on how to address value for other aquatic pesticides.

DACO PART 10 - Value

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (specifically, use history information, published papers, scientific rationales and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance that follows.

Efficacy: Laboratory Trials

Laboratory trials are useful to determine the most appropriate rates of the pesticide to be tested in small-scale/operational trials. Laboratory trials should test a range of rates, higher and lower than the proposed label rates, representing a gradual change in the pesticide concentration, so that the appropriate rate (toxic threshold) can be determined. The trial should use positive (registered alternative) and negative (untreated) controls and include a scientifically valid number of replicates for each rate tested. Quantitative sampling should be conducted and a clear acceptable performance standard should be identified and justified (that is, growth ratings and/or percentage coverage where the test results are acceptable [pass] or not [fail]).

For the remedial treatment of algae, bacteria, molluscs or other organisms, testing should be carried out using samples of water collected from areas where the organisms are apparent. The concentration of organisms (level of contamination) should be quantified (hemacytometer algae counts, chlorophyll levels, cfu/mL, percentage surface coverage, etc.) prior to testing and should be representative of actual levels found in contaminated sites.

For the prevention of growth of algae, bacteria, molluscs or other organisms, testing should be carried out using samples of water collected from areas where the organisms are present only at a non-problematic baseline level. Treated and untreated water samples should then be incubated over the time necessary to demonstrate efficacy.

Efficacy: Small-Scale/Operational Trials

Small-scale and/or operational trials should be provided to confirm that the rates established during laboratory trials are effective when used in actual use conditions. Testing should be carried out with a method of application representative of the label directions and in a body of water most representative of the proposed use:

  • Where the undesirable organisms are apparent for remedial claims.
  • Where organisms are present only at non-problematic baseline levels for prevention claims.

If representative of the use pattern, the body of water should contain plants and sediments at the bottom, which would represent a worst case scenario. Testing should demonstrate control or reduction of organisms over a representative period of time, using the optimal range of rates determined by the laboratory trials. The data package should include a detailed description of the protocol, all the results, a scientifically valid number of replicates, monitoring of weather conditions and a quantitative analysis of the organisms (for example, cfu/mL or percentage surface coverage). A clear, acceptable performance standard should be identified and justified (specifically, growth ratings and/or percentage surface coverage where the test results are acceptable [pass] or not [fail]). If the trials are conducted outside of Canada, a scientific rationale should be submitted to explain how the submitted efficacy trials can be used to support Canadian uses. If applicable, photographic evidence can be provided as additional information.

6.3 USC 3 (Empty Food and Feed Storage Structures and Areas)

USC 3 includes a variety of pest control products. The following guidance is given with respect to products used for sanitizing surfaces in empty storage rooms (empty food/feed storage rooms and surfaces, storage bins, etc.). Refer to the Value Guidelines for New Plant Protection Products and Label Amendments for information on how to address value for other pesticides related to USC 3.

DACO Part 10 - VALUE

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (that is, use history information, published papers, scientific rationales, and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance below.

Efficacy: Laboratory Trials

Laboratory trials should be conducted to establish the most appropriate range of rates of the product. This is achieved by testing a wide range of rates, higher and lower than the proposed rates. The experimental protocol should be representative of the description of the pest problem and use-pattern of the product. For example, for a fumigant, individually inoculating stainless steel carriers with bacterial, fungal or viral plant pathogens and placing the carriers in different areas, within a negative pressure chamber, where the fumigant is released for the proposed contact time, would be an acceptable simulation. If different types of surfaces (for example, concrete and wood) are to be treated, carriers representative of these surfaces should be included as part of testing. ASTM E2111 may be referred to for the preparation of bacterial, fungal and/or viral cultures and for inoculation of carriers and efficacy testing. Typically, the following plant pathogens are included as part of testing for plant pathogen disinfectants: Botrytis cinerea, Clavibacter michiganensis, Didymella bryoniae, Fusarium oxysporum, Pythium aphanidermatum, Pepino mosaic virus and Tobacco mosaic virus. Also, if a product is to be used in empty storage rooms ranging in temperatures, the range of temperatures that will be permitted on the label are considered the highest and lowest tested temperature where the product achieved the required kill rate of plant pathogens during the trials. The trial should be based on sound scientific principles using appropriate controls, include a scientifically valid number of replicates for each rate tested, a detailed description of the protocol and all the results should be submitted. Clear acceptable performance standards should be identified and justified (specifically, growth ratings where the test results are acceptable [pass] or not [fail]).

Efficacy: Small-scale/Operational Trials

Depending on the results of laboratory trials, small-scale and/or operational trials may be advisable, such as in cases where the efficacy of the product can be seen only in real-scale rooms (for example, fumigants). For example, stainless steel carriers inoculated with bacterial, fungal or viral plant pathogen cultures could be installed throughout the storage area for testing. The product should be released over the recommended contact time prior to bacterial, fungal or viral recovery from the carriers. Testing may be carried out using a protocol similar to that mentioned above in the laboratory section. Alternatively, a test could be conducted to demonstrate that the level of saturation of the carrier achieved during laboratory trials is achieved by the treatment during the small-scale/operational trials carried out in the empty storage area. Clear acceptable performance standards should be identified and justified (specifically, growth ratings where the test results are acceptable [pass] or not [fail]).

6.4 USC 5 (Greenhouse Food Crops) and USC 6 (Greenhouse Non-food Crops)

USC 5 and USC 6 include a variety of pest control products. The following guidance is given with respect to products used as greenhouse sanitizers and disinfectants on hard and porous surfaces where food or non-food crops may be present. The value information that should be provided to support greenhouse sanitizers and disinfectants should use challenge organisms representative of the pest problem found in greenhouses. It should be noted that only plant pathogens that have been included as part of testing can be listed on the product label. For guidance on efficacy testing protocols, refer to requirements highlighted under USC 15 and USC 19. Refer to the Value Guidelines for New Plant Protection Products and Label Amendments for information on how to address value for other greenhouse pesticides.

6.5 USC 15 (Indoor Hard-surfaces)

DACO Part 10 - Value

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (that is, use history information, published papers, scientific rationales and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance below.

Efficacy: Laboratory Trials

Laboratory trials should be provided to demonstrate the efficacy of the proposed product for each type of surface to be treated. The trial should test a range of rates, within the proposed label rates, representing a gradual change in the active ingredient concentration so that if applicable to the use, the most appropriate rates can be determined and further tested in small-scale/operational trials. The trial should be based on sound scientific principles including a negative (untreated) control and a scientifically valid number of replicates. The data package should include study protocols, all the results, and a clear and justified acceptable performance standard. Typically, sanitizers require a 99.9% reduction in five minutes for non-food contact surfaces. The following methods can be used.

Food-contact Surfaces

Use the United States Environmental Protection Agency (USEPA) method DIS-TSS 04 Sanitizing Rinses for Previously Cleaned Food-contact Surfaces or similar methods.

Non-food Contact Surfaces

Use USEPA method DIS-TSS 10 Sanitizer Test for Inanimate Surfaces, ASTM E1153, ASTM 2011, ASTM 2197 or similar methods.

Fogging

The experimental protocol should be representative of the description of the pest problem and use-pattern of the product. For example, for a sanitizer applied by fogging, individually inoculating stainless steel carriers and placing them in different areas, within a negative pressure chamber, where the sanitizer is released for the proposed contact time, would be an acceptable simulation. ASTM E2111 may be referred to for the preparation of cultures and for inoculation of carriers and efficacy testing.

Efficacy: Small-Scale/Operational Trials

Depending on the results of laboratory trials, small-scale and/or operational trials may be advisable, such as in cases where the efficacy of the product can be seen only in real-scale rooms (such as fogging). For example, stainless steel carriers inoculated with microorganisms could be installed throughout the area for testing. The product application should be carried out over the recommended contact time prior to microbial recovery from the carriers. Testing may be carried out using a carrier method similar to that mentioned above. Alternatively, a test could be conducted to demonstrate that the level of saturation of the carrier achieved during laboratory trials is achieved during small-scale/operational trials carried out in the empty room.

6.6 USC 17 (Industrial Process Fluids)

DACO Part 10 - Value

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (specifically, use history information, published papers, scientific rationales and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance below.

Efficacy: Laboratory/Small-Scale Trials

Laboratory or small-scale trials should be carried out to demonstrate the efficacy of the proposed product for each of the industrial process fluids that are intended to be treated. The study design should approximate as closely as possible the conditions found in the specific process fluids. For instance, samples of actual process fluids, taken from relevant industrial sites, may be used. Alternatively, synthetic process fluids should have a pH and micronutrients concentrations typically found in actual fluids. Relevant, acclimated bacteria, fungi and algae associated with industrial process fluid problems or inoculum taken directly from contaminated process fluid may be used in the tests. The tests should be carried out using a range of rates, including a low concentration that does not sufficiently control the microorganisms, and a high concentration above which no added benefit is observed. This will help to determine a range of rates that is effective but not excessive.

If the label claims that the proposed product removes biofilms, the trials should demonstrate the rates at which an established biofilm is removed. If the label claims are for biofilm prevention, then the trials may show that planktonic microbes treated with the proposed product do not form surface biofilms. Both of these studies may be carried out in a Robin's device or other representative apparatus. The studies should be scientifically valid and include untreated controls and a sufficient number of replicates. Trial reports submitted in support of pesticidal claims should include a detailed description of the experimental protocol.

Efficacy: Operational Trials

Confirmatory operational trials (within a paper mill, a cooling tower, oilfield, etc.) should be conducted over a representative period of time so that the most appropriate rates determined in the laboratory/small-scale trials can be verified. This data should monitor the concentration of the active ingredient and microbial growth, and record any problems in the process prior to and during the treatment of the process waters with the proposed product. Frequency of testing should be determined to provide sufficient information to assess the effect of the biocide, and the sampling frequency should be justified with a rationale. It is recognized that economic or safety factors might preclude the incorporation of a negative control; however, a positive control such as data showing the performance of another biocide in the same (or a similar) system should be provided for comparison purposes. Note that historical records of performance of the system within industries or sites using the biocide could be supplied as operational information.

6.7 USC 18 (Materials)

DACO Part 10 - Value

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (specifically, use history information, published papers, scientific rationales and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance below.

Efficacy: Laboratory Trials

General Principles

Laboratory trials should be carried out to demonstrate the efficacy of the product for each type of material to be treated. The experimental protocols should be representative of the description of the pest problem and use-pattern of the product. Laboratory trials are carried out to determine the appropriate rates of the product. This is achieved by testing a wide range of rates, above and below the proposed label rates. Contaminated materials (such as spoiled paint) can be used as inoculums. Alternatively, acclimated microorganisms from culture collections can be used and a rationale should be provided to explain why these strains are relevant to the pest problem. Trial reports submitted in support of pesticidal claims should include a detailed description of the experimental protocol.

In-can Material Preservatives

Testing should be conducted using representative samples of the materials to be preserved, and using the specific microorganisms known to cause in-can contamination, at concentrations/levels that would trigger the need for the preservative to be present. Re-inoculation with the test pests at regular intervals (for example, weekly) to simulate repeated contamination/challenges may be necessary. However, re-inoculation(s) should be carried out at levels and intervals most representative of actual manufacturing processes and/or use of the material. A scientific rationale should be provided explaining the need for repeated challenges and how it relates to actual manufacturing processes, storage and end-use of the preserved item. Suggested protocols for efficacy testing include ASTM D2574, D4783, E979 and E2275. Since in-can preservatives are solely for the control of microorganisms inside containers, laboratory trials are sufficient to demonstrate the efficacy of the preservative.

Dry-film Material Preservatives

Testing should be conducted with coupons coated with material (paint/caulk/sealants, etc.) and challenged with microorganisms that cause the degradation or aesthetic disfigurement of the dry-films, at concentrations/levels that would trigger the need for the dry-film to possess pesticidal properties. Suggested protocols for efficacy testing include ASTM G29, D4300 and D5590. Small-scale and/or operational trials are usually useful in addition to laboratory trials.

Preservatives to be Used in the Manufacture of Articles

Testing should be conducted with each type of the treated material appearing on the label or group of material (cotton, wool, PVC, etc.) using specific microorganisms that cause the problem on the article, at concentrations/levels that would trigger the need for the articles to possess pesticidal properties. Materials with similar properties may be grouped so that value information from one sample of the materials represents the entire group. When grouping is used, a scientific rationale and/or bridging data should be submitted explaining how the grouped materials are similar, taking into account physical and chemical characteristics, the use pattern and the pest problem.

If appropriate to the laboratory scale, the expected protection period (number of washes of a fabric, etc.) should also be determined. Suggested protocols for efficacy testing include ASTM G21, E1428, E2180, D2020, AATCC 30, 100 and 147. As laboratory trials may not be always representative of use-conditions, small-scale and/or operational trials should also be provided.

Efficacy: Small-Scale Trials

Small-scale trials should be conducted to simulate actual use conditions to which the dry-film or the article will be exposed. In some cases, a small-scale trial may be provided instead of an operational trial. In such cases, a scientific rationale should be provided describing how the accelerated study reflects the long term use of the treated material/article, keeping in mind the actual use conditions to which the product is exposed. However, when the proposed label claims include outdoor uses of articles or dry-films, an operational trial should typically be provided. Small-scale trials may involve a humidity chamber in an accelerated test, but should not involve direct inoculation of the coated samples/articles. Suggested protocols for efficacy testing include ASTM G160, C1338, D3273, D5589, D5590 and D6329.

Efficacy: Operational Trials

Operational trials should be conducted (especially for outdoor uses) in conditions as representative as possible of the conditions in which the material/article will be used. The microorganism populations and the pest problem (for example, mold coverage) should be monitored periodically and the length of the expected protection period (such as number of months/years) should also be determined. Trials should be carried out with a sufficient number of replicates and show reasonable preservation of the treated products in comparison to the untreated control. The efficacy studies, using the appropriate rates determined during laboratory/small-scale trials should demonstrate that the use of the pesticide would control bacteria, fungi and/or algae growth on the treated dry-film/material under actual use conditions. The testing time frame should be consistent with the actual length of use (in other words, life expectancy) of the product. Trial reports submitted in support of preservation claims should include a detailed description of the experimental protocol and of the results. Suggested protocols for efficacy testing include ASTM D358, D1006, D3274 and D3456.

6.8 USC 19 (Other Indoor Surfaces, Water and Air)

DACO Part 10 - Value

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (specifically, use history information, published papers, scientific rationales and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance below.

Efficacy: Laboratory Trials

Laboratory trials should be provided to determine the appropriate rates of the biocide to be confirmed in small-scale/operational trials. This is achieved by testing a wide range of rates, higher and lower than the proposed rates. The experimental protocol should be representative of the description of the pest problem (specifically, using the specific microorganisms that cause the problem at the particular use-site, at concentrations/levels that would trigger the need for biocidal control on porous surfaces, in water or in the air). Trials should be carried out using samples of each surface type/textile/water/air that is included in the label claims. If biofilm removal is claimed, biofilm specific tests should be performed as well (for example, coupons). Trial reports submitted in support of pesticidal claims should include a detailed description of the experimental protocol.

Testing may be carried out using protocols derived from AOAC/ASTM/AATCC/EPA such as ASTM: E2471, E2274, E2406, AOAC 972.04, EPA DIS-TSS 08, 11, 13, 14, etc.

Efficacy: Small-Scale/Operational Trials

Depending on the results of laboratory trials and on the proposed uses, small-scale and/or operational trials may be advisable. This could be applicable, for example, when treating water or air where the pesticidal effect can be monitored only with larger scale analysis. For fogging uses, testing with the rates found effective in the laboratory trial may be carried out in an empty room where stainless steel carriers, inoculated with microorganisms, have been placed throughout the area. The product application should be carried out over the recommended contact time prior to microbial recovery from the carriers. Alternatively, a test could be conducted to demonstrate that the level of saturation of the carrier achieved during laboratory trials is achieved during small-scale/operational trials carried out in the empty room.

6.9 USC 22 (Underwater Structures and Material)

DACO Part 10 - Value

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (specifically, use history information, published papers, scientific rationales and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance below.

Efficacy: Laboratory Trials

Data that determines the release rate of the active ingredient(s) should be provided. Testing may be carried out using protocols derived from ASTM D6442 and/or D5108.

For copper-based antifouling paints, a determination of the copper release rate may be sufficient alone to support the efficacy requirements for registration. Based on published literature, a copper release rate above 10 mg/cm2/day is considered effective.

For antifouling paints based on active ingredients other than copper, a laboratory trial demonstrating the intrinsic biocidal efficacy of a formulation's active ingredient against fouling organisms may be useful. The use of tolerant (or resistant) and sensitive species should be considered when selecting test organisms. Furthermore, the selected organisms should be directly relevant to fouling of underwater structures/surfaces and should be relevant to the proposed uses of the product. Sound scientific principles, including positive controls (for example, a sample treated with a currently registered product) and negative controls (untreated), should be used when designing protocols. Clear acceptable performance standards should be identified and justified (specifically, growth ratings where the test results are acceptable [pass] or not [fail]).

Efficacy: Small-Scale/Operational Trials

Small-scale or operational trials should be provided for antifouling paints based on new active ingredients (or in support of a significantly different formulation of existing products) in a simulated or actual environment.

  • Small-scale trials could include static raft testing panels coated with the antifouling formulation using the application method on the proposed label's directions for use, and immersed in freshwater and/or salt water (depending on label claims), over a period of at least 12 months or until the antifouling coating fails. Testing may be carried out using a protocol derived from ASTM D3623.
  • Operational trials should be designed to replicate dynamic conditions encountered during the service of the antifouling formulation. These tests are usually patch tests in which a strip (or patch) of a ship's hull is coated with the formulation. Fouling is then monitored regularly to assess product efficacy. The trial report should also include a discussion on the historical presence of fouling and a summarized description of the waters where the ship has travelled.

Both of these types of efficacy trials should include the following information. Results should be reported quantitatively. Fouling organisms should be identified by type (algae, molluscs, etc.) and quantified in terms of individual counts, percentage surface coverage, or biomass, in addition to providing a clear and justified performance standard that is considered commercially acceptable. Anecdotal or photographic evidence are not sufficient alone but may, in some cases, be considered useful supplementary information to quantitative data. Other information such as surface composition and preparation, number of coats of antifouling paint, method of application, dry film thickness (µm) and coverage (m2 per L of paint) should also be included. Detailed information on the testing should be provided, including information regarding the duration of the trial, the presence of tides and currents, salinity, the historical presence of fouling in the test site, etc. Finally, the trials should include a positive control consisting of panels/patches coated with an antifouling product of established efficacy and sufficient replicates of the test panels/patches (a minimum of three) to assess the consistency of the results. Testing may be carried out using protocols derived from ASTM standard tests.

6.10 USC 23 (Wood)

Note: These guidelines do not pertain to termite or other insect claims.

6.10.1 Wood Preservatives

Heavy-duty wood preservatives are those that are typically applied to wood by pressure treatment in an industrial treating plant.

DACO Part 10 - Value

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (specifically, use history information, published papers, scientific rationales and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance that follows.

Note: It is important to provide a description of how the preservative components are fixed or stabilized within the wood.

Efficacy: Laboratory Trials

Laboratory studies are useful to demonstrate that the product functions as claimed and to determine the appropriate rates to be tested in the field trials. Laboratory trials (soil block, fungal cellar, soft rot tests, etc.) should test a range of retention levels (including an untreated control) so that the appropriate rate (specifically, toxic threshold) can be determined. A suitable number of replicates should be included to ensure the results are scientifically valid. Wood composite samples should be tested if the preservative is to be used to treat wood composites. Testing may be carried out using a protocol derived from AWPA E10 Standard Method of Testing Wood Preservatives by Laboratory Soil Block Cultures.

Efficacy: Small-Scale Trials

As Canadian wood species in general tend to be more difficult to treat than the commercial wood species used in the United States, it is important that treatability data be provided. This data should be provided for at least two commercially relevant Canadian wood species, representing an easy to treat wood species such as red pine, and a difficult to treat wood species such as white spruce. The retention rates found to be effective in the laboratory trials and proposed on the label should be attained in these Canadian wood species. The treatability data does not have to be a separate study. It is often provided as a component of the initiation of field trials (see the information that follows). Data should also be provided to demonstrate how well the preservative is fixed or stabilized within the wood. This is typically assessed indirectly by measuring the rate of leaching of the active ingredients from the treated wood. Testing may be carried out using protocols derived from AWPA E11 Standard Method of Determining the Leachability of Wood Preservatives and AWPA E19 Standard Method for Determining Preservative Fixation of Waterborne Wood Preservatives.

Efficacy: Operational Trials

Field trials should be provided for each major proposed use of the treated wood (ground contact, above-ground contact, marine use, freshwater use, etc.). The field trials should be conducted at two Canadian sites (one of which should be in the British Columbia coastal region to represent a worst-case decay environment in the Canadian context). However, if these data are not currently available, surrogate field data from the United States test sites using American species such as Southern Yellow Pine may be used to support registration until meaningful Canadian data has been generated.

Testing may be carried out using a protocol derived from AWPA E7 Standard Method of Evaluating Wood Preservatives by Field Tests with Stakes. Other ground contact field trials (for example, post or pole tests) may also be important in providing data to support this use. For above-ground uses, separate field trials representative of this use (for example, L-joint, lap joint, decking studies) should be provided. For all field trials, a sufficient number of replicates should be included to provide meaningful results. Soil depletion/dissipation studies, often conducted in conjunction with stake/post field tests may be useful to support the preservative fixation/leaching data requirements.

6.10.2 Antisapstain Products

Antisapstain products are applied in a saw mill to green, freshly cut lumber with the goal of imparting short-term protection against sapstain fungi during the transport and storage of the lumber.

DACO Part 10 - Value

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (specifically, use history information, published papers, scientific rationales and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance that follows.

Efficacy: Laboratory Trials

Laboratory trials are useful to demonstrate that the product is capable of inhibiting the growth of fungi associated with sapstain and to determine a range of rates to test in the small-scale/operational trials. Laboratory studies should be scientifically valid, representative of how the product is to be used, and include a sufficient number of replicates to demonstrate the inherent variation in the effectiveness of the product.

Efficacy: Small-Scale/Operational Trials

Small-scale or operational trials (specifically, sawmill studies) that represent the actual use conditions of the product should be provided to support the registration of antisapstain products. Canadian wood species that are commercially important and susceptible to sapstain (Douglas-fir, Western Hemlock, etc.) should be used in the trial. Treatment with different solution concentrations, including untreated controls (for example, water treatment) should be made with deposition rates verified by assay. Performance standards should be stated as to what the industry considers acceptable sapstain protection. Ideally, the trial will include the following treatment rates: boards at an inadequate deposition rate, at an effective rate, and at a higher rate that provides no additional benefit against sapstain fungi. The boards should then be closely stacked and wrapped in plastic to represent industry practices, with periodic examinations for the development of sapstain. The duration of the test should cover the period of protection being claimed (for example, 3 to 9 months). The degree of sapstain damage should be evaluated and reported in a quantitative manner (percentage surface covered in stain, distribution of boards with different degrees of staining, etc.), and the trials should include a sufficient number of replicates to capture the natural variability in the treatment (for example, 80 boards/treatment). If the operational trial is conducted using a dip-treatment method, and an effective deposition rate is determined, the results can be used to support spray box treatment. It is understood that there are many parameters to spray box treatment (nozzle pressure, speed lumber passes through the spray box, etc.) that can be adjusted to achieve a particular target deposition rate. However, if the trial is carried out by treating the wood by spray, dip treatment should be supported with data showing that the deposition rate found to be effective can be achieved with dip treatment.

6.10.3 Joinery/Millwork Preservatives

Joinery wood preservatives are applied to finished wood products that are typically not in ground contact, for example, window frames, doors and milled articles such as spindles and banisters, with the goal of imparting long-term, in-service protection against decay fungi.

DACO Part 10 - Value

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (specifically, use history information, published papers, scientific rationales and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance that follows.

Note: It is important to provide a description of how the preservative components are fixed or stabilized within the wood.

Efficacy: Laboratory/Small-Scale Trials

Laboratory/small-scale trials (such as soil block tests) should be provided and test a range of retention/deposition levels (including an untreated control) so that the appropriate rate (for example, toxic threshold) can be determined. A suitable number of replicates should be included to ensure the results are scientifically valid. Testing may be carried out using a Soil Block Test protocol. Additional data such as a leaching test could also be useful.

Efficacy: Operational Trials

Above-ground field trials representative of a typical or worst-case decay scenario for millwork/joinery should be conducted at two Canadian sites (one of which should be in the coastal region of British Columbia to represent a worst-case decay environment in the Canadian context). The AWPA E9 Standard Field Test for the Evaluation of Wood Preservatives to be Used in Non-soil Contact (specifically, L-joint test) or AWPA E16-98 Standard Field Test for Evaluation of Wood Preservatives to be Used Out of Ground Contact: Horizontal Lap-joint Method, have been found to be acceptable methodologies to generate field data for millwork/joinery preservatives. For all field trials, relevant commercial Canadian wood species should be used, and a sufficient number of replicates should be included to provide meaningful results. If above-ground field trial data from Canada is not currently available, surrogate field data from United States test sites using American species such as Southern Yellow Pine may be used to support registration until meaningful Canadian data has been generated. Treatment data using relevant Canadian wood species should be provided to demonstrate that the retentions/depositions found to be effective are achievable.

6.10.4 Remedial Wood Preservatives

Remedial wood preservatives are typically applied to previously treated wood that has shown signs of fungal decay.

DACO Part 10 - Value

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (specifically, use history information, published papers, scientific rationales and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance below.

Efficacy: Laboratory Trials

Laboratory trials (soil block, fungal cellar, soft rot tests, etc.) may be useful to determine an appropriate rate (such as toxic threshold). A suitable number of replicates should be included to ensure the results are scientifically valid. Testing may be carried out using a protocol derived from AWPA E10 Standard Method of Testing Wood Preservatives by Laboratory Soil Block Cultures. Additional data such as a leaching test could also be useful.

Efficacy: Small-Scale/Operational Trials

Small-scale and/or operational trials should be provided to establish the efficacy of the remedial wood preservative. If the preservative is for the remediation of utility poles, the trials could include treating a number of in-service poles that are under fungal attack. The application methods used in the trials should be representative of those on the label. The trials should be scientifically valid, with a sufficient number of replicates. A comparison of the results against untreated controls should demonstrate that there is a value to the product in order to support registration.

6.11 USC 29 (Swimming Pools)

The information below regarding swimming pool and spa products has been separated in two different sections, "sanitizer" and "algaecide", which are then divided into chemical products and generating devices subsections.

6.11.1 Sanitizers

Commercial and domestic class products do not typically require supporting efficacy data if the following criteria are met:

  • Contain as their only active ingredient a registered active ingredient of the type set out in schedule II of the Pest Control Products Regulations.
  • Use a Health Canada model label, as per (in time of printing): DIR93-05 Scheduling of Selected Pool and Spa Chemicals and DIR93-06 Model Labels for Pool and Spa Products not Eligible for Scheduling.
  • Contain no formulant that could interfere with the active ingredient.

Efficacy data and/or a scientific rationale explaining how the change in guarantee, when compared to scheduled products or the added formulant(s) impact the pool chemistry (total dissolved solids, pH, etc.) are required for products that do not fall within the categories above (products containing multiple active ingredients and/or formulants, etc.). Information on non-safety adverse effect would also be useful.

DACO Part 10 - Value

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (specifically, use history information, published papers, scientific rationales and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance that follows.

6.11.1.1 Chemical Sanitizers

Efficacy: Laboratory Trials for Non-scheduled Sanitizers

Laboratory trials based on the Association of Official Analytical Chemists (AOAC) Method for Water Disinfectants for Swimming Pools (965.13) are required. This study measures the time required to provide a 6-log kill, where the microorganism population should be quantified after the first 30 seconds of exposure to the sanitizer and at least every minute thereafter until a complete kill is obtained. Water conditions (for example, pH, temperature or hardness) should be reported and 400 ppm CaCO3 hard water should be used when testing products requiring dilution in water, as recommended by the USEPA Scientific Advisory Panel on Germicide Test Methodology (1993). The proposed sanitizer should be used at a concentration that provides control equivalent to 0.6 ppm free available chlorine, which typically results in a complete kill of the inoculum (106 organisms/mL) within 30 seconds.

Methods from Australian Pesticides and Veterinary Medicines Authority (APVMA) and OECD may also be found to be acceptable (APVMA Guide for Demonstrating Efficacy of Pool and Spa Sanitisers and OECD No. 170: Guidance Document for Demonstrating Efficacy of Pool and Spa Disinfectants and Field Testing).

Viruses and protozoa are also recognized as causing pool-associated illnesses, therefore studies demonstrating the control of the microorganisms may be required, depending on the nature of the proposed antimicrobial pesticide (for example,non-oxidizing) and proposed label claims.

Efficacy: Operational Trials for Non-scheduled Sanitizers

The effective rates derived from the laboratory trials should be confirmed with an operational trial conducted in at least two swimming pools and/or spas (depending on the proposed uses) over an entire season (4 to 12 months). The trials should be based on USEPA method DIS-TSS 12 Swimming Pool Water Disinfectants or similar methods.

6.11.1.2 Chlorine/Bromine Generating Devices

If registration of multiple models is sought, each individual model requires its own label, owner's manual and efficacy data package, including chlorine/bromine output data and a letter certifying electrical safety. If it can be demonstrated that different models are identical in voltage, current, etc., then only one set of output data could be provided to support the identical models. A rationale should be provided when grouping the output data.

Efficacy: Laboratory/Small-Scale/Operational Trials

Hypochlorous and hypobromous acid are well characterized swimming pool and spa sanitizers with proven efficacy. Unless unusual claims are made, the only data required would be testing to ensure that the device is able to produce the maximum output of chlorine/bromine claimed on the label.

The chlorine/bromine output can be demonstrated using the following method:

  • Install the device on a pool or container filled with a known volume.
  • Before starting the device, adjust the water parameters within the normal range of pool or spa water. Verify chlorine/bromine levels with a titration test kit or other precise analytical method.
  • Add salt to the lower level recommended in the owner's manual.
  • Run the device at the super chlorinate output setting of the controller for a defined period of time.
  • Monitor free available chlorine/bromine levels at regular time intervals using a titration test kit or other precise analytical method.
  • Calculate the daily free available chlorine/bromine output based on the water volume and device operation time.
  • The trial should be repeated at least three times (three separate trials conducted in triplicates) to ensure that results are reproducible.

The data package should include a report with the detailed protocol and calculations used to determine chlorine/bromine output, the results from each trial in mg/L of HOCl and any other relevant information required for the evaluation of the data. The protocol should specify the volume of water used in the trial, the water parameters, the device running time, the water temperature, and the titration test kit description (or other method) used to determine chlorine/bromine levels. Note that the device should demonstrate the ability to produce daily 3 ppm (for swimming pools) or 5 ppm (for spas) in the maximum pool volume appearing on the label.

6.11.2 Algaecides

Antimicrobial pesticides used only to control algae do not require fast kill rates. However, they should provide sufficient control compared to an untreated control and information should be provided to demonstrate their compatibility with registered sanitizers (specifically, chlorine and/or bromine). Copper (for example, copper sulphate) is a well-established algaecide. Minimal data and/or information may be required to support its registration if it is proposed to be used within the range of 0.2-1.0 ppm Cu.

DACO Part 10 - VALUE

In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value (specifically, use history information, published papers, scientific rationales and trial data). It is recognized that some of these types of information may not always be available to support a proposed product, especially in the case of new active ingredients. In such cases, efficacy trials should be designed to test the proposed product in conditions representative of the proposed label uses, at the proposed range of rates based on the guidance below.

6.11.2.1 Chemical Algaecides

Efficacy: Laboratory Trials

Laboratory trials should be provided to show the inherent algaecidal properties of the product against algae species representative of pools and/or spas (Chlorella pyrenoidosa, Phormidium inundatum, Phormidium retzii, etc.). All tests should be carried out at least in triplicate and should include a quantitative assessment of the algae control (cell count, chlorophyll a measures, etc.). Anecdotal evidence such as "clear water" or "water appears algae-free" is not sufficient since they do not allow an objective assessment of the product's efficacy. The algaecide should be tested in combination with the sanitizer(s) with which it will be used in pools and/or spas, as well as without sanitizer. The trials should also contain a control treated with a registered chlorine or bromine sanitizer (no algaecide). The performance standard for laboratory trials should be identified and justified.

Efficacy: Operational Trials

For operational trials, testing should demonstrate algaecidal properties using the optimal rate determined by the laboratory trials. Results from two properly maintained swimming pools of different sizes equipped with a pump, in-line filter and heater should be provided. The algaecide should be tested in combination with the sanitizer(s) with which it will be used in pools and/or spas. In addition, a pool treated with a registered chlorine/bromine sanitizer (no algaecide) should be included as a control. The testing should be conducted at least in triplicate over a period of no less than 30 consecutive days under climatic conditions similar to the Canadian swimming pool season where a quantitative analysis of the algae problem is included. It is important to note that the performance of the algaecide used with a sanitizer as per label directions should provide added benefit over a standard chlorine treatment.

The report should include the following information:

  • The water capacity in litres of the test pool or spa and the turnover time of the water.
  • The daily bather load.
  • The amount and identity of all chemicals added to the swimming pool or spa water (including the time, site and method).
  • The range of chemical characteristics of the swimming pool or spa water, such as pH, metals (for example, copper) calcium hardness, total hardness, free available chlorine and total alkalinity.
  • The physical characteristics of the swimming pool or spa water, including temperature and clarity, determined at least daily.
  • Meteorological data, including air temperature, rainfall and number of hours of sunlight (determined daily) for outdoor pools or spas.
  • The concentration of the active ingredient is to be maintained in the swimming pool water monitored daily.
  • A complete description of the test method employed to monitor the concentration of the active ingredient contained in the pool or spa water and raw data should be submitted and any rating system used should be explained.
  • A quantitative assessment of algae growth (cfu/mL, chlorophyll a, etc.) for each sampling.
6.11.2.2 Copper Ion Releasing Devices

If registration of multiple models is sought, each individual model typically requires its own label, owner's manual and efficacy data package, including copper output data and a letter certifying electrical safety. If it can be demonstrated that different models are identical in voltage, current, etc., then only one set of output data could be provided. A rationale should be provided when grouping the output data.

Efficacy: Laboratory/Small-Scale/Operational Trials

Data should be provided to demonstrate and confirm that the copper output of the device is able to achieve 0.2 ppm copper in the maximum pool volume as claimed on the label. The copper output can be demonstrated using the following method:

  • Install the device on a pool/spa or container filled with a known volume.
  • Before starting the device, adjust the water parameters within the normal range of pool/spa water and verify copper levels with a copper test kit or other precise analytical method.
  • Run the device for a defined period of time.
  • Monitor copper levels at regular time intervals using a copper test kit or other precise analytical method.
  • Calculate the daily copper output based on the water volume used in the trials and the device operation time.
  • The trial should be repeated at least three times (three separate trials conducted in triplicates) to ensure that results are reproducible.

The package should include a report with the detailed protocol used to determine copper output, the results from each trial and any other relevant information required for the evaluation of the data. The protocol should specify the volume of water used in the trial, the water parameters, the device running time, the water temperature and the test kit (or other method) used to determine copper levels. The life of the copper electrode should also be specified.

If the device cannot maintain a minimum of 0.2 ppm of copper, a laboratory trial as well as a confirmatory operational trial (both described in the chemical algaecides section above) should be provided to demonstrate the efficacy of the proposed product to control algae in swimming pools and/or spas.

List of Abbreviations

AATCC
American Association of Textile Chemists and Colorists
AOAC
Association of Official Analytical Chemists
APVMA
Australian Pesticides and Veterinary Medicines Authority
ASTM
American Society for Testing and Materials
AWPA
American Wood Protection Association
CaCO 3
Calcium carbonate
°C
Degrees Celsius
cfu
Colony forming unit
CSA
Canadian Standards Association
Cu
Copper
DACO
Data Code
EPA
Environmental Protection Agency
ETL
Edison Testing Laboratories
kg
Kilogram
L
Litre
m 2
Square metre
m 3
Cubic metre
mL
Millilitre
MPN
Most probable number
OECD
Organisation for Economic Co-operation and Development
PCPA
Pest Control Products Act
PCPR
Pest Control Products Regulations
PMRA
Pest Management Regulatory Agency
ppm
Parts per million
USC
Use-site category
UL
Underwriters Laboratories Inc.
µm
Micrometre

Appendix I Model Labels for Pool and Spa Devices

Chlorine/Bromine Generating Devices

For each device model for which registration is sought, three labels should be provided: a device label, a label for the replacement cell and an owner's manual. It is important to note that a device label and owner's manual can reference only one particular device model. All units should be represented using the metric system followed by the imperial units in brackets if needed (for example, 5000 L [1321 gallons]).

Label

The label text should appear on the device itself, on the box or packaging in which the device is sold and in the owner's manual. The device label should conform to the following template.

DEVICE BRAND NAME AND MODEL NUMBER (NO.)

CHLORINE/BROMINE GENERATOR

CONTROLS BACTERIA AND ALGAE
in
Swimming Pool (Spa) Waters

Domestic OR Commercial

A maximum of X litres of water can be treated with one [device name] unit.
Maximum output of hypochlorous (or hypobromous) acid equivalent to X kg of
free available chlorine/bromine per day.

For swimming pools, a range of 1-3 ppm of free available chlorine/bromine must be maintained.
[AND / OR]
For spas, a range of 3-5 ppm of free available chlorine/bromine must be maintained.

READ THE LABEL AND OPERATING MANUAL BEFORE USING
KEEP OUT OF REACH OF CHILDREN
REGISTRATION NO. XXXXX PEST CONTROL PRODUCTS ACT

WARNING: operating [device name] without water flow through the cell can cause a build up of flammable gases, which can result in FIRE OR EXPLOSION.

[For commercial device, add the following:]
NOTICE TO USER: This pest control product is to be used only in accordance with the
directions on the label. It is an offence under the Pest Control Products Act to use this
product in a way that is inconsistent with the directions on the label. The user assumes the risk to persons or property that arises from any such use of this product.

Company Name, Street Address (or P.O. Box No.)
City, Province, Postal Code

Replacement Cell Label

A label is required on replacement cells or electrodes to ensure that the user will install only cells or electrodes that were evaluated when the device was registered. A model label is provided below:

REPLACEMENT CELL BRAND NAME AND MODEL NO.

Replacement electrode for the chlorine/bromine generating device [Name of the device and model] REGISTRATION NUMBER XXXXX, PEST CONTROL PRODUCTS ACT. This cell must only be used on this model of chlorine/bromine generating device.

Read the Label, the Installation Manual and Operation Manual of the chlorine/bromine
generating device [name of the device and model] before using.

Company Name, Street Address (or P.O. Box No.)
City, Province, Postal Code

Note: In cases where the replacement cell or electrode can be used in more than one registered device, the label of this cell or electrode will need to specify with which device model it is compatible. Only cells that have been evaluated with a particular power supply can be used with that power supply. It is important to note that output data should be generated for each power supply and cell combination.

Owner's Manual

The owner's manual should describe the device functions/components as a whole, as well as include a physical description and the specifications of the device.

As the installation and operation manual will differ significantly among devices, it is not possible to provide a model template. However, the following standard statements or equivalent wording should be found in the manual:

  • "WARNING: To reduce the risk of injury, do not permit children to operate this device."
  • "WARNING: heavy pool (or spa) usage, and higher temperatures may require higher chlorine/bromine output to maintain proper free available chlorine/bromine residuals."
  • "Heavy bather loads may trigger the need for additional chlorine (Optional: [insert pool sanitizer name]) to be added to maintain an appropriate chlorine/bromine residual in the water."
  • "DO NOT add pool or spa chemicals directly to the skimmer. This may damage the cell."
  • "Maintaining high salt and chlorine/bromine levels above recommended range can contribute to corrosion of pool or spa equipment."
  • "Check the expiry date of the test kit as test results may be inaccurate if used after that date."
  • "Follow all aspects of the local and Canadian Electrical Code(s) when installing this device."
  • "The life expectancy of the electrode is [number of hours] hours under normal use conditions."
  • "When replacing the electrode, only use replacement electrodes having a label that clearly states that it is a replacement electrode for the chlorine/bromine generating device [Name of the device and model], REGISTRATION NUMBER XXXXX, PEST CONTROL PRODUCTS ACT."
  • "NOTE: For outdoor pools, chlorine/bromine residuals can be protected from destruction by sunlight by addition of stabilizer (cyanuric acid)."
  • For devices that can be used on spas: "For proper sanitation, spas should be completely drained periodically. The number of days between COMPLETE SPA DRAINAGE is equal to the volume of spa water in litres, divided by 10 times the maximum number of daily spa users. Refill spa with water and repeat DIRECTIONS FOR USE of the device."

Health and Hyperthermia warnings for spa devices:

  • "People with a medical condition should consult a physician before entering pool or spa water."
  • "Maximum spa water usage temperature is 40°C. Bathing in spa water at 40°C should not exceed 15 minutes."
The owner's manual should also contain the water parameters to be maintained as part of daily maintenance, as described below for swimming pools and spas.
Parameters Swimming Pool Spa
Free available chlorine (or bromine) 1.0-3.0 ppm 3.0-5.0 ppm
pH 7.2-7.8 7.2-7.8
Total alkalinity 100-120 ppm 100-120 ppm
Calcium hardness 200-300 ppm 150-200 ppm
Salt X ppm
(specific to each device)		 X ppm
(specific to each device)
Cyanuric acid (stabilizer, used in outdoor pools only) 30-100 ppm 30-100 ppm

Copper Ion Releasing Devices

For each device model for which registration is sought, three labels should be provided: a device label, a label for the replacement cell and an owner's manual. It is important to note that a device label and owner's manual can reference only one particular device model. All units should be represented using the metric system followed by the imperial units in brackets if needed (for example, 5000 L [1321 U.S. gallons]).

Label

The label text should appear on the device itself, on the box or packaging in which the device is sold and in the owner's manual. The device label should conform to the following template.

DEVICE BRAND NAME AND MODEL NO.

COPPER IONS RELEASING DEVICE

CONTROLS ALGAE
in
Swimming Pool (Spa) Waters

Domestic OR Commercial

A maximum of X L of water can be treated with one [device name] unit.

WARNING: Staining of pool (spa) surfaces may occur due to deposit of copper salts. Excessive levels of copper will increase the probability of this occurrence.

READ THE LABEL AND OPERATING MANUAL BEFORE USING
KEEP OUT OF REACH OF CHILDREN
REGISTRATION NO. XXXXX PEST CONTROL PRODUCTS ACT

[For commercial device, add the following:]
NOTICE TO USER: This pest control product is to be used only in accordance with the directions on the label. It is an offence under the Pest Control Products Act to use this product in a way that is inconsistent with the directions on the label. The user assumes the risk to persons or property that arises from any such use of this product.

Company Name, Street Address (or P.O. Box No.)
City, Province, Postal Code

Replacement Cell Label

A label is required on replacement cells or electrodes to ensure that the user will install only cells or electrodes that were evaluated when the device was registered. A model label is provided below.

REPLACEMENT CELL BRAND NAME AND MODEL NO.
DEVICE BRAND NAME AND MODEL NO. REPLACEMENT CELL

Replacement electrode for the copper releasing device [Name of the device and model] REGISTRATION NUMBER XXXXX, PEST CONTROL PRODUCTS ACT. This cell must only be used on this model of copper ionization device.

Read the Label, the Installation Manual and Operation Manual of the copper ionization device [name of the device and model] before using.

Company Name, Street Address (or P.O. Box No.)
City, Province, Postal Code

Note: In cases where the replacement cell or electrode can be used in more than one registered device, the label of this cell or electrode will need to specify with which device model it is compatible. Only cells that have been evaluated with a particular power supply can be used with that power supply. It is important to note that copper output data should be generated for each power supply and cell combination.

Owner's Manual

The owner's manual should describe the device functions/components as a whole, as well as include a physical description and the specifications of the device.

As the installation and operation manual will differ significantly among devices, it is not possible to provide a model template. However, the following standard statements or equivalent wording should be found in the manual:

  • "WARNING: To reduce the risk of injury, do not permit children to operate this device."
  • Heavy bather loads may trigger the need for additional chlorine/bromine (Optional: [insert pool sanitizer name]) to be added to maintain an appropriate chlorine/bromine residual in the water.
  • "DO NOT add pool chemicals directly to the skimmer. This may damage the unit."
  • "Check the expiry date of the test kit as test results may be inaccurate if used after that date."
  • For electrical devices: "Follow all aspects of the local and Canadian Electrical Code(s) when installing this device."
  • "Use [name of the pool sanitizer] to maintain an appropriate chlorine/bromine residual in the water."
  • "The expected life expectancy of the electrode is [number of hours] hours under normal use conditions."
  • "When replacing the electrode, only use replacement electrodes having a label that clearly states that it is a replacement electrode for the copper ion releasing device [Name of the device and model], REGISTRATION NUMBER XXXXX, PEST CONTROL PRODUCTS ACT."
  • "Refer to the Directions for use of your chlorine/bromine sanitizer for appropriate water parameters".

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