Re-evaluation Decision RVD2018-36, Sodium Bromide and Its Associated End-use Products
Pest Management Regulatory Agency
30 November 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-36E-PDF (PDF version)
Table of Contents
- Re-evaluation Decision
- Outcome of Science Evaluation
- Regulatory Decision for Sodium Bromide
- Next Steps
- Other Information
- Appendix I Registered Products Containing Sodium Bromide as well as Bromine and Chlorine Electrolysis Devices
- Appendix II Comments and Responses
- 1.0 Comments Related to the Health Risk Assessment
- 2.0 Other Comments
- Appendix III Label Amendments for Products Containing Sodium Bromide as well as Chlorine Electrolysis Devices
- Appendix IV References Considered Following Publication of PRVD2017-10
Re-evaluation Decision
Under the authority of the Pest Control Products Act, all registered pesticides must be regularly re-evaluated by Health Canada’s Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental safety standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies. The PMRA applies internationally accepted risk assessment methods as well as current risk management approaches and policies.
Sodium bromide is registered in Canada to control slime-forming bacteria and other microorganisms that form problematic biofilms on the surfaces of equipment in contact with process waters in pulp and paper mills, cooling towers, and air washers. It is also used as a sanitizer to control bacteria and algae in swimming pool and spa waters. Currently registered products containing sodium bromide and associated end-use products as well as bromine and chlorine electrolysis devices are listed in Appendix I.
This document presents the final regulatory decisionFootnote 1 for the re-evaluation of sodium bromide, including the required risk mitigation measures to protect human health and the environment. All products containing sodium bromide that are registered in Canada, as well as electrolysis devices that may be used with sodium bromide products and sodium bromide spa products used in combination with potassium monopersulfate which appear in Schedule 2Footnote 2 of the Pest Control Product Regulations, are subject to this re-evaluation decision. This re-evaluation decision has undergone a 90-day consultation period on the Proposed Re-evaluation Decision PRVD2017-10, Sodium Bromide,Footnote 3 which ended on 29 October 2017.
Health Canada received comments relating to the health risk assessment. These comments are summarized in Appendix II along with the responses by Health Canada. The comments did not result in a change to the risk assessment. Therefore, this decision is consistent with the proposed re-evaluation decision stated in PRVD2017-10. A reference list of data used as the basis for the proposed re-evaluation decision is included in PRVD2017-10. Further data used in the re-evaluation decision, including data received during the consultation period, are listed in Appendix IV.
Outcome of Science Evaluation
With respect to human health, risks of concern were identified for the use of sodium bromide products used in combination with bromine electrolysis devices and sodium bromide spa sanitizers used in combination with potassium monopersulfate. No risks of concern were identified for all other uses of sodium bromide when used according to the revised label directions. Also when used according to the revised label directions, sodium bromide is not expected to pose risks of concern to the environment.
Regulatory Decision for Sodium Bromide
Health Canada has completed the re-evaluation of sodium bromide. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of some uses of sodium bromide is acceptable. An evaluation of available scientific information found that some uses of sodium bromide products meet current standards for protection of human health and the environment when used according to the conditions of registration, which include required amendments to label directions. Certain uses of sodium bromide are cancelled as health risks have not been found to be acceptable. Label amendments, as summarized below and listed in Appendix III, are required for all remaining sodium bromide products as well as chlorine electrolysis devices. No additional data are required.
Risk Mitigation Measures
Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law.
Human Health
To protect the general population from residential exposure, the following risk-reduction measures are required for continued registration of sodium bromide in Canada:
- Cancellation of all bromine swimming pool or spa electrolysis devices and sodium bromide products intended to be used with swimming pool or spa electrolysis devices.
- Sodium bromide spa products used in combination with potassium monopersulfate will be removed from Schedule 2 of the Pest Control Product Regulations as part of future regulatory amendments and will no longer be permitted for use.
- All chlorine swimming pool or spa electrolysis devices are to indicate that they are not to be used with bromide products.
- All remaining sodium bromide swimming pool and spa products are to indicate that they are not to be used in combination with electrolysis, ozonation or UV.
To protect industrial workers from occupational exposure, the following risk-reduction measures are required for continued registration of sodium bromide in Canada:
- Commercial industrial sodium bromide product labels are to require the use of protective eyewear, chemical-resistant coveralls over long-sleeved shirt, long pants, and chemical-resistant gloves and footwear when handling the concentrate and contacting treated process fluids.
- Commercial industrial sodium bromide product labels are to indicate that they are for use with closed loading and transfer systems only.
Environment
To protect the environment, the following risk-reduction measures are required for continued registration of sodium bromide in Canada:
- Commercial industrial sodium bromide products are to indicate that the detoxification of effluent prior to discharge is required due to the toxicity of hypobromous acid to aquatic organisms.
Next Steps
To comply with this decision, the required mitigation measures must be implemented on all product labels sold by registrants no later than 24 months after the publication date of this decision document. Appendix I lists the products containing sodium bromide, as well as bromine and chlorine electrolysis devices, that are registered under the authority of the Pest Control Products Act.
In addition, products that are cancelled will be phased-out following the implementation timeline outlined below:
- One (1) year of sale by registrant from the publication date of this decision document, followed by;
- One (1) year of sale by retailer from the last date of sale by registrant, followed by;
- One (1) year of permitted use from the last date of sale by retailer.
Other Information
Any person may file a notice of objectionFootnote 4 regarding this decision on sodium bromide within 60 days from the date of publication of this Re-evaluation Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of Canada.ca or contact the PMRA’s Pest Management Information Service.
Appendix I Registered Products Containing Sodium Bromide as well as Bromine and Chlorine Electrolysis Devices1
| Registration Number | Marketing Class | Registrant | Product Name | Formulation Type | Active Ingredient |
|---|---|---|---|---|---|
| 21923 | Technical Grade Active Ingredient | BWA Water Additives US LLC | Liquibrom 100 | Soluble Powder | Sodium Bromide 97% |
| 22737 | Technical Grade Active Ingredient | Bromine Compounds Ltd | Sodium Bromide Technical Microbicide | Solid | Sodium Bromide 98% |
| 24216 | Manufacturing Concentrate | Bromine Compounds Ltd | Sodium Bromide MP Microbicide | Pellets | Sodium Bromide 98% |
| 25331 | Technical Grade Active Ingredient | Albemarle Corporation | Sanibrom 40 Biocide Technical | Solution | Sodium Bromide 40% |
| 25701 | Manufacturing Concentrate | BWA Water Additives US LLC | Liquibrom 4000T Manufacturing Concentrate | Solution | Sodium Bromide 40% |
| 26578 | Technical Grade Active Ingredient | Albemarle Corporation | Sanibrom 45 Biocide Technical | Solution | Sodium Bromide 45.0% |
| 28480 | Technical Grade Active Ingredient | Sani-Marc Inc | Cambrex NaBr | Soluble Granules | Sodium Bromide 99.2% |
| 28824 | Manufacturing Concentrate | Bromine Compounds Ltd | Sodium Bromide MP-SP | Soluble Powder | Sodium Bromide 98% |
| 28825 | Technical Grade Active Ingredient | Bromine Compounds Ltd | Sodium Bromide Technical Microbicide-SP | Soluble Powder | Sodium Bromide 98% |
| 33122 | Technical Grade Active Ingredient | Sani Marc Inc. | Sani Marc NaBr | Soluble Granules | Sodium Bromide 99.3% |
| 21318 | Commercial | Suez Water Technologies & Solutions Canada | Spectrus OX1201 | Solution | Sodium Bromide 40% |
| 21678 | Commercial | Nalco Canada ULC | Acti-Brom 1338 Chlorine Enhancer Biodispersant | Solution | Sodium Bromide 42.8% |
| 21922 | Commercial | BWA Water Additives US LLC | Liquibrom 4000 | Solution | Sodium Bromide 40.0% |
| 22577 | Commercial | Buckman Laboratories of Canada Ltd | Busan 1167 Liquid Microbicide | Solution | Sodium Bromide 40.0% |
| 22578 | Commercial | Buckman Laboratories of Canada Ltd | Bulab 6040 Liquid Microbicide | Solution | Sodium Bromide 40% |
| 23624 | Commercial | Solenis Canada ULC | Biosperse XD9400 | Solution | Sodium Bromide 40% |
| 24770 | Commercial | ICL – IP America Inc | Bromide Plus Microbiocide | Solution | Sodium Bromide 38% |
| 24911 | Commercial | Klenzoid Canada Inc. | Klenzoid Sodium Bromide | Solution | Sodium Bromide 40.0% |
| 25202 | Commercial | Solenis Canada ULC | Spectrum XD9400 Microbiocide Agent | Solution | Sodium Bromide 40% |
| 25320 | Commercial | Chemco Products Inc. | Eclipse 632 Microbicide | Solution | Sodium Bromide 40% |
| 25478 | Commercial | Nalco Canada ULC | Stabrex ST70 | Solution | Sodium Hypochlorite 6.36% Sodium Bromide 9.23% |
| 25930 | Commercial | Occidental Chemical Corporation | Oxychem Towerbrom 90M Tablets | Tablet | Trichloro-s-Triazinetrione 83% Sodium Bromide 7% |
| 26145 | Commercial | Nalco Canada ULC | Stabrex ST100 | Solution | Sodium Hypochlorite 6.36% Sodium Bromide 9.23% |
| 26539 | Commercial | Chemtreat Inc | Chemtreat CL-40 | Solution | Sodium Bromide 40.0% |
| 26557 | Commercial | Baker Hughes Canada Company | Cl2out 1000 Slimicide | Solution | Sodium Bromide 40.0% |
| 26856 | Commercial | BASF Canada Inc | Basabrom 40 | Solution | Sodium Bromide 40% |
| 26945 | Commercial | Kemira Chemicals Canada Inc | Fennosan 111-C | Solution | Sodium Bromide 40% |
| 27275 | Commercial | Occidental Chemical Corporation | Towerbrom 60M Granules | Granular | Sodium Dichloro-s-Triazinetrione 57% Sodium Bromide 6.86% |
| 27275.01 | Commercial | State Industrial Products | Bio-Bully | Granular | Sodium Dichloro-s-Triazinetrione 57% Sodium Bromide 6.86% |
| 27663 | Commercial | Nalco Canada ULC | Towerbrom 960 | Solubles Granules | Sodium Dichloro-s-Triazinetrione 57% Sodium Bromide 6.86% |
| 27674 | Commercial | Nalco Canada ULC | Towerbrom 991 | Tablet | Trichloro-s-Triazinetrione 83% Sodium Bromide 6.86% |
| 27759 | Commercial | Nalco Canada ULC | Acti-Brom 1318 Chlorine Enhancer | Solution | Sodium Bromide 42.8% |
| 27796 | Commercial | Produits Chimiques Magnus Ltée | Magnatrol 47A | Solution | Sodium Bromide 40% |
| 28357 | Commercial | Dubois Chemicals Canada Inc | X-Cell 430 | Solution | Sodium Bromide 40% |
| 28729 | Commercial | Aquarian Chemicals Inc | Aquabrom 4000 | Solution | Sodium Bromide 40% |
| 29141 | Commercial | Nalco Canada ULC | Stabrex ST70 For Kits | Solution | Sodium Hypochlorite 6.36% Sodium Bromide 9.23% |
| 29408 | Commercial | Enviro Tech Chemical Services Inc | Brommax 7.1 Microorganism Control Chemical | Solution | Trichloro-s-Triazinetrione 7.45% Sodium Bromide 10.09% |
| 29501 | Commercial | IPAC Chemicals Ltd | Ipacide LWT 629 | Solution | Sodium Bromide 40% |
| 29880 | Commercial | Chemtreat Inc | Cl-4907 Microorganism Control Chemical | Solution | Trichloro-s-Triazinetrione 7.45% Sodium Bromide 10.09% |
| 29971 | Commercial | Nalco Canada ULC | Controlbrom CB70 | Solution | Sodium Bromide 30% |
| 30035 | Commercial | Produits Chimiques Magnus Ltée | Magnatrol 477a | Solution | Trichloro-s-Triazinetrione 7.45% Sodium Bromide 10.09% |
| 30146 | Commercial | Chemtreat Inc | Chemtreat Cl-41 | Solution | Sodium Bromide 40% |
| 30291 | Commercial | NCH Canada Inc | Chem-Aqua 42171 | Solution | Trichloro-s-Triazinetrione 7.45% Sodium Bromide 10.09% |
| 30659 | Commercial | IPAC Chemicals Ltd | Ipacide LWT 639A | Solution | Trichloro-s-Triazinetrione 7.45% Sodium Bromide 10.09% |
| 31031 | Commercial | Water Sciences Technologies LLC | K-Brom 40 | Solution | Sodium Bromide 38% |
| 31106 | Commercial | Québec-O-Chimie Inc | Unica 310 | Solution | Trichloro-s-triazinetrione 7.45% Sodium Bromide 10.09% |
| 31359 | Commercial | Centrale Thermique BC-Plus | A-210 | Solution | Trichloro-s-triazinetrione 7.45% Sodium Bromide 10.09% |
| 32155 | Commercial | U.S. Water Services, Inc | Biotrol 407 | Solution | Trichloro-s-triazinetrione 7.45% Sodium Bromide 10.09% |
| 32521 | Commercial | U.S. Water Services, Inc | Biotrol C140 | Solution | Sodium Bromide 40% |
| 32654 | Commercial | Klenzoid Canada Inc | Aquacide STBR | Solution | Trichloro-s-Triazinetrione 7.45% Sodium Bromide 10.09% |
| 33031 | Commercial | Solesco Inc | Solubact-BR | Solution | Sodium Hypochlorite 6.36% Sodium Bromide 9.23% |
| 33059 | Commercial | Nalco Canada ULC | Stabrex ST70CAN | Solution | Sodium Hypochlorite 6.36% Sodium Bromide 9.23% |
| 25299 | Domestic | KIK Holdco Company Inc | Spaguard Brominating Concentrate | Granular | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.7% |
| 26561 | Domestic | KIK Holdco Company Inc | Aqua Chem Clear And Simple Spa Brominating Concentrate | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.7% |
| 26562 | Domestic | KIK Holdco Company Inc | Omni Brominating Concentrate For Spas & Hot Tubs | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.7% |
| 26563 | Domestic | KIK Holdco Company Inc | Spa Essentials Sanitizer Brominating Concentrate | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.7% |
| 26579 | Domestic | Sani-Marc Inc | Easy Brome Sanitizer For Spas | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 27197 | Domestic | Sani-Marc Inc | Calypso Spa Power Brome # 15 | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 27308 | Domestic | Beachcomber Hot Tubs Plus Inc | Bromo Blast | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 27329 | Domestic | I.P.G/G.P.I Independent Pool Group Inc | Aquapro Spa Easy Brome | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 27589 | Domestic | Capo Industries Ltd | Spaboss Brominating Granules | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 27589.02 | Domestic | Aqua Coastal Imports Inc | Aqua Coastal Brominating Granules | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 27589.04 | Domestic | Capo Industries Ltd | Jacuzzi Brominating Granules | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 27888 | Domestic | Sani-Marc Inc | Spa Sani Brom | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 28099 | Domestic | Capo Industries Ltd D.B.A. Pool Chemical Industries | Spachem Brominating Granules | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.7% |
| 28100 | Domestic | Catalina Spas | Catalina Spas Bromine Granules | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.7% |
| 28101 | Domestic | Arctic Spas | Arctic Pure Peak Boost Brominating Granules | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.7% |
| 28230 | Domestic | Canadian Tire Corp. Ltd | Aquarius Spa Gran-Brom | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 29102 | Domestic | Backyard Brands Inc | Dazzle Bromine Granules For Hot Tub | Granular | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 29396 | Domestic | Lawrason's Inc | Spa Life EZ Brom | Soluble Granules | Sodium Dichloro-s-Triazinetrione 47.5% Sodium Bromide 14.88% |
| 29782 | Domestic | Bromitron Corporation | Bromicharge | Solid | Sodium Bromide 98% |
| 29878 | Domestic | Le Club Piscine Plus Québec C.P.P.Q. Inc. | Bromine Gran | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 30023 | Domestic | Lawrason's Inc | Clear Spa EZ Brom | Soluble Granules | Sodium Dichloro-s-Triazinetrione 47.5% Sodium Bromide 14.88% |
| 30289 | Domestic | Hydropool Inc | EZ Brome + | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 30290 | Domestic | Mursatt Chemicals Ltd | Brome + | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 30776 | Domestic | Arch Chemicals Inc | GLB Green Free Algaecide | Soluble Powder | Sodium Bromide 98% |
| 30804 | Domestic | KIK Holdco Company Inc | Soft Soak Clearly Clean For Bromine Spas | Granular | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.7% |
| 30986 | Domestic | Alliance Trading Inc | Brom Granules | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 31109 | Domestic | KIK Holdco Company Inc | Soft Soak Brominating Granules | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.7% |
| 31691 | Domestic | Backyard Brands Inc | Mineraluxe Bromine Granules For Hot Tub | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 31880 | Domestic | Easy 123 Pool Care LLC | Clorox Spa Brominating Concentrate | Granular | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.7% |
| 31956 | Domestic | Sani-Marc Inc | Halogen | Soluble Granules | Sodium Bromide 99.2% |
| 32027 | Domestic | Trevi | Brom-Gen | Soluble Granules | Sodium Bromide 99.2% |
| 32075 | Domestic | Central Spa & Pool Supply | Bromine Generator Salt | Soluble Granules | Sodium Bromide 99.2% |
| 32085 | Domestic | Le Club Piscine Plus Québec C.P.P.Q. Inc. D.B.A. Club Piscine Super Fitness | Eclipse | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.79% Sodium Bromide 14.6% |
| 32182 | Domestic | Sani-Marc Inc | Bromide Salt | Soluble Granules | Sodium Bromide 99.2% |
| 32214 | Domestic | Capo Industries Ltd | Marquis 1 Step Bromine Granules | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 32519 | Domestic | Trevi | EZ San | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.6% |
| 32874 | Domestic | Groupe D’Achat MP Inc | Fusion | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.85% |
| 33159 | Domestic | Capo Industries Ltd D.B.A. Pool Chemical Industries | PoolSuppliesCANADA.CA Spa Brominating Granules | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.7% |
| 33205 | Domestic | Capo Industries Ltd D.B.A. Pool Chemical Industries | The Cover Guy Brominating Granules | Soluble Granules | Sodium Dichloro-s-Triazinetrione 52.7% Sodium Bromide 14.7% |
| Bromine Electrolysis Devices | |||||
| 27890 | Domestic | Hot Tub Solutions Inc, DBA Bluwater Technology Inc. | Genesis Automatic Bromine Generator | Device | Not applicable |
| 27890.01 | Domestic | Hot Tub Solutions Inc, DBA Bluwater Technology Inc. | Cal Clarity Automatic Bromine Generator | Device | Not applicable |
| 27890.03 | Domestic | Hot Tub Solutions Inc, DBA Bluwater Technology Inc. | Hydropool Salt Water Bromine System | Device | Not applicable |
| 29628 | Domestic | Groupe Gecko Alliance Inc. | In. Clear | Device | Not applicable |
| 30525 | Domestic | Hot Tub Solutions Inc, DBA Bluwater Technology Inc. | Genesis Blu Fusion Automatic Bromine Generator for Spa Sanitizing | Device | Not applicable |
| Chlorine Electrolysis Devices | |||||
| 20151 | Domestic | C.L. Marketing Inc. | Lectranator Salt Chlorine Generator Model 840 | Device | Not applicable |
| 24583 | Commercial | Goldline Controls Inc. | Aqua Rite (Canada) Electrolytic Chlorine Generator | Device | Not applicable |
| 25615 | Domestic | Lectranator Systems Inc. | Cubby Salt Water Purifier Model AC5 | Device | Not applicable |
| 26962 | Commercial | Lectranator Systems Inc. | Lectranator II Model 7200 | Device | Not applicable |
| 26966 | Domestic | KIK Holdco Company Inc. | Mineral Springs (Model V1) | Device | Not applicable |
| 26967 | Domestic | KIK Holdco Company Inc. | Mineral Springs (Model V2) | Device | Not applicable |
| 27476 | Commercial | Lectranator Systems Inc. | Lectranator Soft Touch Model ST840C (.91KG/CL2/DAY) | Device | Not applicable |
| 27477 | Commercial | Lectranator Systems Inc. | Lectranator Digital Model DIG 840C (.91KG/CL2/DAY) | Device | Not applicable |
| 27840 | Domestic | Lectranator Systems Inc. | Lectranator Soft Touch Model ST60 | Device | Not applicable |
| 27841 | Domestic | Lectranator Systems Inc. | Lectranator Soft Touch Model ST48 | Device | Not applicable |
| 27842 | Domestic | Lectranator Systems Inc. | Lectranator Soft Touch Model ST36 | Device | Not applicable |
| 27843 | Domestic | Lectranator Systems Inc. | Lectranator Digital Model DIG 60 | Device | Not applicable |
| 27844 | Domestic | Lectranator Systems Inc. | Lectranator Digital Model DIG 48 | Device | Not applicable |
| 27845 | Domestic | Lectranator Systems Inc. | Lectranator Digital Model DIG 36 | Device | Not applicable |
| 27899.0 | Domestic | Lectranator Systems Inc. | Tubby Model ST1 | Device | Not applicable |
| 27899.01 | Domestic | Artic Spas | Onzen | Device | Not applicable |
| 27899.02 | Domestic | Coast Spas Manufacturing Inc. | Ecoclean | Device | Not applicable |
| 28193 | Domestic | Zodiac Pool Systems Inc. | Apurem with PLC1400 Cell | Device | Not applicable |
| 28324 | Commercial | Goldline Controls Inc. | H40 Electronic Chlorine Generator | Device | Not applicable |
| 28324.01 | Commercial | Goldline Controls Inc. | Swimpure Plus Electronic Chlorine Generator | Device | Not applicable |
| 28324.03 | Commercial | Goldline Controls Inc. | Ritepro Electronic Chlorine Generator | Device | Not applicable |
| 28324.2 | Commercial | Goldline Controls Inc. | Aqua Logic Electronic Chlorine Generator | Device | Not applicable |
| 28325 | Domestic | Goldline Controls Inc. | Aquarite Cul Electrolytic Chlorine Generator | Device | Not applicable |
| 28325.1 | Domestic | Goldline Controls Inc. | GEN-R-8 Electrolytic Chlorine Generator | Device | Not applicable |
| 28325.3 | Domestic | Hayward Pool Products Canada Inc. | DIY Electrolytic Chlorine Generator | Device | Not applicable |
| 28325.4 | Domestic | Hayward Pool Products Canada Inc. | Omnilogic Electrolytic Chlorine Generator | Device | Not applicable |
| 28325.5 | Domestic | Goldline Controls Inc. | Aquarite Long Life | Device | Not applicable |
| 28365 | Domestic | Pentair Water Pool and Spa Inc. | Intellichlor Electronic Chlorine Generator Model IC40 | Device | Not applicable |
| 28366 | Domestic | Pentair Water Pool and Spa Inc. | Intellichlor Electronic Chlorine Generator Model IC20 | Device | Not applicable |
| 28593 | Domestic | Hayward Pool Products Canada Inc. | Aqua Trol Above-Ground Pool Automation | Device | Not applicable |
| 28593.01 | Domestic | Hayward Pool Products Canada Inc. | Swimpure RJ Above Ground Pool Automation | Device | Not applicable |
| 28651 | Commercial | Chlorking Inc. | Chlorking Saline Chlorination System | Device | Not applicable |
| 28816 | Commercial | Ecolab Inc. | Ecolab Aqua Balance Pure Comfort Mineral Pool & Spa System | Device | Not applicable |
| 29088 | Commercial | Chlorking Inc. | Chlorking Saline Chlorination System, Model CHLOR-5.0 | Device | Not applicable |
| 29220 | Commercial | Ecolab Inc. | Ecolab Aqua Balance Pure Comfort Mineral Pool & Spa System Model 5.0 | Device | Not applicable |
| 29376 | Commercial | C.L. Marketing Inc. | Zilvoldhf | Device | Not applicable |
| 29541 | Commercial | Chlorking Inc. | Chlorking Saline Chlorination System, Model Mini 2.0 | Device | Not applicable |
| 29705 | Commercial | Ecolab Inc. | Ecolab Aqua Balance Pure Comfort Mineral Pool & Spa System Model 2.0 | Device | Not applicable |
| 29954 | Commercial | Clearblue Ionizer Inc. | Clearblue | Device | Not applicable |
| 30130 | Domestic | Blue Falls Manufacturing Ltd. | Onzen II Salt Water Spa Chlorinator | Device | Not applicable |
| 30232 | Domestic | Zodiac Pool Systems Inc. | Zodiac Aquapure EI Series APURE35C | Device | Not applicable |
| 30251 | Domestic | Watkins Manufacturing Corporation | Ace Salt Water Sanitizing System | Device | Not applicable |
| 30295 | Commercial | Davey Water Products Proprietary Ltd. | Eco-Matic COMM 360 Automatic Chlorine Generator | Device | Not applicable |
| 30296 | Commercial | Davey Water Products Proprietary Ltd. | Eco-Matic COMM 1200 Automatic Chlorine Generator | Device | Not applicable |
| 30297 | Commercial | Davey Water Products Proprietary Ltd. | Eco-Matic COMM 2400 Automatic Chlorine Generator | Device | Not applicable |
| 30298 | Commercial | Davey Water Products Proprietary Ltd. | Eco-Matic COMM 4000 Automatic Chlorine Generator | Device | Not applicable |
| 30299 | Commercial | Davey Water Products Proprietary Ltd. | Eco-Matic COMM 160 Automatic Chlorine Generator | Device | Not applicable |
| 30383 | Domestic | Bestway Inflatables & Materials Corporation | Hydro-Force Flowclear Chlorinator Model 58215 | Device | Not applicable |
| 30479 | Domestic | Zodiac Pool Systems Inc. | Nature2 Fusion Inground | Device | Not applicable |
| 30480 | Domestic | Zodiac Pool Systems Inc. | Nature2 Vision Pro | Device | Not applicable |
| 30481 | Domestic | Zodiac Pool Systems Inc. | Nature2 Fusion Soft | Device | Not applicable |
| 30493 | Domestic | Lectranator Systems Inc. | Pool Pilot Deluxe | Device | Not applicable |
| 30494 | Domestic | Lectranator Systems Inc. | Pool Pilot Digital Nano | Device | Not applicable |
| 30794 | Domestic | Les Équipements de Piscines Carvin Inc. | Saniclear 40 | Device | Not applicable |
| 30927 | Commercial | Hayward Pool Products Canada Inc. | Saline C(TM) 6.0 Salt Chlorine Generator | Device | Not applicable |
| 30930 | Domestic | Pentair Water Pool and Spa Inc. | Intellichlor Electronic Chlorine Generator Model IC60 | Device | Not applicable |
| 30931 | Domestic | Pentair Water Pool and Spa Inc. | Intellichlor Electronic Chlorine Generator Model IC15 | Device | Not applicable |
| 30942 | Domestic | Les Équipements de Piscines Carvin Inc. | Saniclear20 | Device | Not applicable |
| 30976 | Commercial | Ecosmarte Planet Friendly Inc. | Chem-Saver Swimming Pool System | Device | Not applicable |
| 31002 | Domestic | Intex Development Company Ltd. | Krystal Clear(TM) Ozone & Saltwater System Model ZS8110 | Device | Not applicable |
| 31003 | Domestic | Intex Development Company Ltd. | Krystal Clear Saltwater System Model CS7110 | Device | Not applicable |
| 31004 | Domestic | Intex Development Company Ltd. | Krystal Clear Saltwater System & Pump Model CS7111 | Device | Not applicable |
| 31016 | Domestic | Watkins Manufacturing Corporation | Ace Retro Salt Water Sanitizing System | Device | Not applicable |
| 31158 | Commercial | TMI Salt Pure Corporation | XMCG Automatic Chlorine Generator | Device | Not applicable |
| 31159 | Commercial | TMI Salt Pure Corporation | 2XMCG Automatic Chlorine Generator | Device | Not applicable |
| 31186 | Domestic | Astral Pool PTY Ltd. | VX7 Salt Chlorine Generator | Device | Not applicable |
| 31187 | Domestic | Astral Pool PTY Ltd. | VX7T Salt Chlorine Generator | Device | Not applicable |
| 31268 | Domestic | Solaxx | Saltron Mini | Device | Not applicable |
| 31362 | Commercial | Hayward Pool Products Canada Inc. | AQR-XL-LS-CUL | Device | Not applicable |
| 31672 | Domestic | Solaxx | Saltron Retro | Device | Not applicable |
| 32055 | Domestic | Intex Development Company Ltd. | Krystal Clear Saltwater System Model Eco 7111 | Device | Not applicable |
| 32056 | Domestic | Intex Development Company Ltd. | Krystal Clear Saltwater System Model Eco 8110 | Device | Not applicable |
| 32057 | Domestic | Intex Development Company Ltd. | Sand Filter Pump & Krystal Clear Saltwater System Model Eco 15110 | Device | Not applicable |
| 32058 | Domestic | Intex Development Company Ltd. | Sand Filter Pump & Krystal Clear Saltwater System Model Eco 20110 | Device | Not applicable |
| 32059 | Domestic | Intex Development Company Ltd. | Krystal Clear Saltwater System Model Eco 7110 | Device | Not applicable |
| 32203 | Domestic | Les Équipements de Piscines Carvin Inc. | Saniclear 10 | Device | Not applicable |
| 32253 | Domestic | Blue Falls Manufacturing Ltd. | Spaboy | Device | Not applicable |
| 32277 | Domestic | Blue Falls Manufacturing Ltd. | Trainers Pal Salt Water Spa Chlorinator | Device | Not applicable |
| 32473 | Domestic | Zodiac Pool Systems Inc. | Jandy Pro Series Truclear Chlorine Generating System | Device | Not applicable |
| 32550 | Domestic | Intex Development Company Ltd. | 86IN X86IN X28IN Purespa Jet and Bubble Deluxe Set Model SJB-HS-11 | Device | Not applicable |
| 32551 | Domestic | Intex Development Company Ltd. | 77IN Purespa Jet and Bubble Deluxe Massage Set Model SJB-HS-10-1 | Device | Not applicable |
| 32552 | Domestic | Intex Development Company Ltd. | 77IN Purespa Jet Massage Set Model SPJ-HS-10-2 | Device | Not applicable |
| 32769 | Commercial | TMI Salt Pure Corporation | TMI Salt Pure ZX-5 | Device | Not applicable |
| 32813 | Domestic | Les Équipements de Piscines Carvin Inc. | Klor 17/3 | Device | Not applicable |
| 32946 | Domestic | Astral Pool PTY Ltd. | E25 Salt Chlorine Generator | Device | Not applicable |
| 32947 | Domestic | Astral Pool PTY Ltd. | E35 Salt Chlorine Generator | Device | Not applicable |
| 33004 | Commercial | Chlorking Inc. | Chlorking Saline Chlorination System Model "NEXGEN" | Device | Not applicable |
- Table 1 - Note 1
as of 30 August 2018, excluding discontinued products, products with a submission for discontinuation, and scheduled spa sanitizers.
Appendix II Comments and Responses
In response to the consultation for the sodium bromide proposed re-evaluation decision, the following comments were received:
1.0 Comments Related to the Health Risk Assessment
1.1 Toxicology
1.1.1 Water additives
A comment was received from Blu Water Technologies, Inc. indicating that water additives such as pH adjusters and water balancers in spa water may reduce bromide risk, similar to other ions that decrease bromide toxicity in seawater as indicated in PRVD2017-10.
PMRA Response
As noted in PRVD2017-10, evidence from rat toxicity and toxicokinetic data available in the published literature indicate that other ions (for example, chloride, sodium and iodide) decrease the toxicity of bromide. No such information was available for the water additives, and therefore no refinement to the risk assessment can be made.
1.2 Residential Exposure
1.2.1 Bromate formation from related active ingredient BCDMH (1-bromo-3-chloro-5,5-dimethylhydantoin)
A comment was received from Mursatt Chemicals Ltd. regarding the safety of continued use of BCDMH given the concerns identified with the disinfection by-product bromate, which is common to both active ingredients.
PMRA Response
While data for bromate formation as a result of BCDMH use in swimming pools was taken into consideration and used qualitatively in the sodium bromide re-evaluation, this will be considered separately.
Upon completion of the re-evaluation of the individual chemicals (sodium bromide and BCDMH), it will be determined whether a cumulative effects assessment is necessary and if so, this will be performed with all relevant chemicals of the common mechanism group.
1.2.2 Bromate formation as a result of bromine electrolysis generators in spas
A comment was received from Blu Water Technologies, Inc. indicating that bromate formation as a result of spa electrolysis devices is low. These comments suggested that bromate formation would not increase with the higher levels of bromide ion in the water, that operational conditions would limit bromate formation, that bather load would limit bromate formation, and that spas would not be subject to UV exposure. A separate comment from Bromitron Corporation included data on bromate levels in a spa scenario using their specific electrolysis device.
PMRA Response
Robust and reliable data on the concentration of bromate in spas where bromine electrolysis generators are used would be required to confirm whether and by how much their presence affects bromate formation in spas.
The submitted data were for a spa electrolysis device labelled for use with indoor spas or outdoor covered spas which required an initial dosing in the water of 1440 ppm sodium bromide. Bromate was measured after 90 days. A single measurement was taken for each use scenario, therefore the data are not adequate for use in the risk assessment. However, it has been considered as supporting information.
The measured levels of bromate were similar to the mean values from BCDMH which were used in the risk assessment. This supports the registrant comment that bromate formation may not increase with higher levels of bromide ion in the water, and that the use of this type of electrolysis may not significantly increase bromate levels. However, it also shows that bromate formation for a specific electrolysis device was similar to the BCDMH data and therefore supported the use of the surrogate BCDMH bromate information in the risk assessment.
As described in PRVD2017-10, cancer risks associated with bromate and non-cancer risks associated with bromide ion were of concern for all subpopulations for the spa electrolysis devices. The submitted data supports the qualitative bromate assessment. The data did not measure bromide ion levels in the water, and therefore the risk assessment for bromide ion cannot be refined. Risks of concern remain for the spa electrolysis devices.
1.2.3 Ingestion of spa waters and the use of USEPA SWIMODEL for spas
Comments were received from Blu Water Technologies, Inc., Bromitron Corporation, and Gecko Alliance Group Inc. indicating that spa users do not ingest spa water, and therefore the use of the USEPA SWIMODEL for ingestion is not appropriate. They provided comments on dermal and ingestion exposure which were consistent with the risk assessment. They felt that the exposure duration, frequency and life stages in SWIMODEL were not appropriate for spas. They specified that PMRA relied on SWIMODEL exposure for competitive swimmers for the decision not to allow bromine generators in spas.
PMRA Response
It is acknowledged that the USEPA SWIMODEL is based on swimming pool uses rather than spa uses; however, it is the best available model and uses the best available exposure data. Exposure data for competitive swimmers was applied only for products with a swimming pool use, where the activities of a competitive swimmer (swimming laps) would be applicable. For spa uses, only the exposure data from non-competitive swimmers was used in the assessment.
Spa use cannot be considered to have negligible exposure via all routes. Adult users are typically seated in the spa water, and the spa water is heated and moving which is expected to result in a mist of treated water above the water line. Splashing from jets or occupants would be common, as well as incidental oral ingestion from water on the skin or from the ingestion of food or drink kept near the spa. While adults will attempt to minimize their ingestion of spa water, children are likely to play in a spa similarly to how they would play in a small pool.
SWIMODEL notes that exposure estimates via the dermal and inhalation routes should not be calculated for inorganic chemicals, which includes bromide and bromate ions. The overall exposure from dermal, inhalation and oral exposure was considered to be addressed by SWIMODEL’s screening-level oral exposure estimate, which contains assumptions that would be protective of the additional exposure from other routes that could not be quantitatively assessed. Spa-specific data could refine this estimate, but data has not been submitted for this re-evaluation.
1.2.4 Additional data to assess spa exposure
A comment was received from Blu Water Technologies, Inc. indicating that further information on spa exposure to bromide and bromate would refine the risk assessment. They identified that the following would improve the assessment: spa user exposure factors (frequency, duration, life-stages, etc.), primary routes of exposure, levels of bromide ion and bromate ion, and bromate ion levels as a result of electrolysis devices. With the exception of the bromate data described in comment 1.2.2, no additional data were submitted.
PMRA Response
Data were not submitted for spa-specific exposure factors during the consultation period. Given this, the risk assessment could not be refined.
1.2.5 Ingestion of spa water compared to open ocean swimming
Comments were received from Arch Chemicals, Inc., Bromitron Corporation, and Gecko Alliance Group Inc. suggesting that the risk from spa water is lower than that of open ocean swimming or bathing as oral ingestion in spas would be lower, while total salt concentration may be higher in ocean water, and exposure time may be longer in open ocean swimming or bathing.
PMRA Response
The comparison of the exposure to bromide in spa and pool water to seawater was considered in the risk assessment. However, the presence of bromide in the environment does not preclude risks of concern from spa water. Spa-specific data could refine the exposure estimate for spas (see 1.1.1, 1.2.3, and 1.2.4), but data were not submitted for this re-evaluation.
2.0 Other Comments
2.1 Reducing Dose Rates for Scheduled Uses of Sodium Bromide
A comment was received from Arch Chemicals suggesting to reduce the dose rates for scheduled uses of sodium bromide to use rates comparable to other registered sodium bromide products, which were proposed for continued registration.
PMRA Response
The risks of concern identified from the scheduled use of sodium bromide used in combination with potassium monopersulfate as an oxidizer were not addressed in the comments received during the consultation period. Therefore, Schedule 2 of the Pest Control Product Regulations will be revised to remove sodium bromide used in combination with potassium monopersulfate as part of future regulatory amendments.
Notwithstanding the above, the PMRA is considering scheduling the lower rate of sodium bromide for spa products used in combination with available chlorine, present as sodium dichloro-s-triazinetrione, which is acceptable for continued registration.
Appendix III Label Amendments for Products Containing Sodium Bromide as well as Chlorine Electrolysis Devices
The label amendments presented below do not include all label requirements for individual end-use products, such as first aid statements, disposal statements, precautionary statements and supplementary protective equipment. Information on labels of currently registered products should not be removed unless it contradicts the label statements provided below.
Human Health
- Label Amendments for solid Technical Grade Active Ingredients, as well as Manufacturing Concentrates and End-use Products that are Repackaged solid Technical Grade Sodium Bromide:
- Add the signal words “WARNING POISON” to the primary display panel.
- Add “May be fatal if inhaled. DO NOT inhale dusts.” to the PRECAUTIONS section.
- Label Amendments for Products Containing Sodium Bromide with Industrial Uses:
- Add the following to the DIRECTIONS FOR USE section:
“Wear protective eyewear, chemical-resistant coveralls over long-sleeved shirt, long pants, and chemical-resistant gloves and footwear when handling the concentrate and contacting treated process fluids.”
“For use with closed loading and transfer systems only.”
- Add the following to the DIRECTIONS FOR USE section:
- Label Amendments for Products Containing Sodium Bromide with Swimming Pool and Spa Uses:
- Add the following to the PRECAUTIONS section:
“Do not use this product with an electrolysis device (for example, a chlorine generator).”
“Do not use this product with ozonation.”
“Do not use this product with ultraviolet (UV).”
- Add the following to the PRECAUTIONS section:
- Label Amendments for Chlorine Swimming Pool or Spa Electrolysis Devices:
- Add the following to the PRECAUTIONS section:
“Do not use this device with bromide products”
- Add the following to the PRECAUTIONS section:
Environment
- Label Amendments for Products Containing Sodium Bromide with Industrial Uses:
- Add the following to the DIRECTIONS FOR USE section:
“Toxic to aquatic organisms.”
“DO NOT discharge effluent containing this product or the biocide produced into sewer systems, lakes, streams, ponds, estuaries, oceans or other waters unless the effluent has been detoxified by suitable means.”
- Add the following to the DIRECTIONS FOR USE section:
Appendix IV References Considered Following Publication of PRVD2017-10
Information Considered in the Occupational and Non-Occupational Assessment
| PMRA Document Number | Reference |
|---|---|
| 2820762 | 2004, Bromate Sampling 12/09/04. Data Numbering Code: 5.14 |
| 2820780 | 2017, PRVD2017 – Proposed Re-evaluation Decision – Sodium Bromide. Data Numbering Code: 5.14 |
| 2820791 | 2003, A Residential Spa Field Test (Pages 1 to 59). Data Numbering Code: 5.14 |
| 2820792 | 2003, A Residential Spa Field Test (Pages 60 to 119). Data Numbering Code: 5.14 |
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