Regulations Amending the Pest Control Products Regulations (Sodium Hypochlorite and Calcium Hypochlorite): SOR/2024-259
Canada Gazette, Part II, Volume 158, Number 26
Registration
SOR/2024-259 December 9, 2024
PEST CONTROL PRODUCTS ACT
P.C. 2024-1298 December 9, 2024
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending the Pest Control Products Regulations (Sodium Hypochlorite and Calcium Hypochlorite) under section 67footnote a of the Pest Control Products Act footnote b.
Regulations Amending the Pest Control Products Regulations (Sodium Hypochlorite and Calcium Hypochlorite)
Amendments
| Item | Column 4 Signal Words |
Column 5 Precautionary Symbol |
|---|---|---|
| 1 | "Danger — Corrosive to Eyes and Skin" | 
|
| Item | Column 4 Signal Words |
Column 5 Precautionary Symbol |
|---|---|---|
| 2 | (b) "Danger — Corrosive to Eyes and Skin" |
|
Coming into Force
2 These Regulations come into force on the day on which they are registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
Issues
In August 2023, Health Canada published the final re-evaluation decision document Sodium Hypochlorite, Calcium Hypochlorite and Their Associated End Use Products (RVD2023-14), which concluded that continued registration of these products under the Pest Control Products Act (PCPA) was acceptable when used according to revised conditions of registration, including label amendments to signal words and precautionary symbols that communicate information on human health hazards. These revised conditions of registration and label amendments reflect a slightly elevated assessed risk level, further to 62 incident reports (57 humans and 5 domestic animals) that the Pest Management Regulatory Agency (PMRA) received for these products, as of September 1, 2022.
As the Pest Control Products Regulations (PCPR) currently contain provisions reflecting the previous label requirements for sodium hypochlorite and calcium hypochlorite (i.e. the former, less stringent signal words and precautionary symbols), there exists misalignment between the regulations and the re-evaluation decision (RVD2023-14). Consequently, regulatory amendments are needed to ensure alignment with labelling requirements and avoid confusion among product registrants and users regarding the hazards of the products.
Background
The PCPA and its regulations provide the legislative framework for the federal regulation of pest control products in Canada. The Minister of Health’s primary mandate under the PCPA is to prevent unacceptable risks to individuals and the environment from the use of pest control products. To meet this objective, the PCPA requires the Minister of Health to conduct premarket assessments of pest control products to determine if the risks to human health and the environment are acceptable and if the products have acceptable value. If the risks are acceptable and the product has value, the pest control product will be approved and registered for import, manufacture, distribution, and use in Canada. Once the product is registered, the PCPA also requires the Minister of Health to conduct post market assessments (i.e. re-evaluations and special reviews) to confirm that the product meets current scientific standards and hence should continue to be registered. At the end of a re-evaluation, a final decision document is published, which presents the final re-evaluation decision on whether continued registration of products containing the evaluated active ingredient is acceptable. The evaluation of available scientific information will determine if the use of products containing the re-evaluated active ingredient meets current standards for protection of human health and the environment and has acceptable value. This may result in continued registration of products with no changes, continued registration with amendments (with or without product cancellation) or cancellation of all registered products.
In June 2021, a re-evaluation of all products containing sodium hypochlorite and calcium hypochlorite regulated under the PCPA (including products listed in Schedule 2 of the PCPR), was initiated. Sodium hypochlorite and calcium hypochlorite are non-selective and broad-spectrum antimicrobial agents and have multiple uses (including in swimming pools and spas). These products are effective in controlling and preventing the growth of bacteria, algae, fungi, and viruses when used in aqueous solution. The re-evaluation determined that continued registration of products containing sodium hypochlorite and calcium hypochlorite was acceptable when used according to revised conditions of registration, which include label amendments. The final decision was presented in the document: Sodium Hypochlorite, Calcium Hypochlorite and Their Associated End-Use Products (RVD2023-14).
Registered pest control product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed as per the PCPA.
Stakeholders are already required to follow the updated label requirements in RVD2023-14, given that labels of registered pest control products must comply with conditions of registration, including labelling conditions, imposed by the Minister under the PCPA, such as those imposed in a re-evaluation decision. The amendments will therefore not impose any additional requirements on stakeholders. Rather, they will serve to align the requirements of the PCPR and RVD2023-14.
Objective
The amendments will strengthen public health and safety by updating the PCPR label requirements for pest control products containing sodium hypochlorite or calcium hypochlorite to reflect the more stringent label requirements established by RVD2023-14 for those products. The amendments will also ensure consistency in the labelling requirements set out in PCPR and RVD2023-14, thereby helping to avoid confusion among the regulated parties regarding labelling requirements and users regarding the hazards of the products.
For sodium hypochlorite products, the update of “Warning – Corrosive” to ”Danger – Corrosive to eyes and skin” communicates a higher assessed level of risk and seeks to make the user more vigilant when using the product. In addition, the label amendments specify which parts of the body are at higher risk when using the product. The user will therefore be more aware of which actions should be taken to prevent injuries.
The same considerations apply for calcium hypochlorite products, where “Caution - Corrosive” would be updated to ”Danger – Corrosive to eyes and skin,” to communicate a higher assessed level of risk and make the user more vigilant when using the product.
Description
Amendments will be made in the Table to Section 7 in Schedule 2 of the PCPR to align the regulations with the re-evaluation decision. For sodium hypochlorite: the signal words “Warning – Corrosive” will be changed to “Danger – Corrosive to Eyes and Skin.” The shape around the precautionary symbol for sodium hypochlorite would be changed from a diamond to an octagon, consistent with other products that use “danger” in their signal words.
For calcium hypochlorite, the signal words “Caution – Corrosive” will be changed to “Danger – Corrosive to Eyes and Skin.” The shape around the precautionary symbol for calcium hypochlorite would be changed from a triangle to an octagon, consistent with other products that use “danger” in their signal words.
Regulatory development
Consultation
Section 28 of the PCPA requires the Minister of Health to consult the public before making a decision about the registration of a pest control product following completion of a re-evaluation or special review. Further to this requirement, the proposed re-evaluation decision PRVD2022-21, Sodium Hypochlorite, Calcium Hypochlorite and Their Associated End-use Products, underwent a public 90-day consultation period commencing on December 14, 2022, and ending on March 14, 2023. The re-evaluation decision proposed the continued registration of sodium hypochlorite and calcium hypochlorite products in Canada, with recommended updates to label directions and precautions to reflect higher assessed risk levels, reflect current labelling standards and improve clarity.
During public consultation, written comments and additional information may be submitted to the PMRA. All comments received during the 90-day public consultation period on a proposed re-evaluation decision are taken into consideration, which could result in revised risk mitigation measures, in preparation of the re-evaluation final decision document.
Health Canada received a general comment from the public related to the value of sodium and calcium hypochlorite in swimming pools and washing machines during the public consultation period. As indicated in the re-evaluation decision, the value assessment has determined that sodium and calcium hypochlorite products are effective in controlling and preventing the growth of bacteria, algae, fungi, and viruses when used in aqueous solution. Therefore, the comment did not result in changes to the proposed re-evaluation decision.
This amendment was not prepublished in the Canada Gazette, Part I, as the changes are minor and technical in nature, and do not impose additional costs on stakeholders. Further, extensive public consultations relevant to this issue were held during the re-evaluation process, and stakeholders have already had a chance to provide their comments on labelling requirements for products containing sodium hypochlorite and calcium hypochlorite.
Modern treaty obligations and Indigenous engagement and consultation
The assessment of modern treaty implications (AMTI) reports on whether implementation of the regulation will have any implications on modern treaties. Preliminary analysis was conducted and indicated that these amendments will have no impacts on modern treaty obligations. The amendments could have minor impacts on Indigenous people who use products containing sodium hypochlorite and calcium hypochlorite (i.e. Indigenous people would benefit from consistency between labelling requirements in the PCPR and RVD2023-14); these impacts would be no different from those on other individuals. Given that the amendments are minor, and that they promote public health and safety, it is not expected that concerns would be raised by Indigenous groups.
The PMRA is not aware of Indigenous-owned businesses that produce products containing sodium hypochlorite and calcium hypochlorite.
Instrument choice
There are no viable alternatives outside of a regulatory amendment, as the status quo would result in an inconsistency between the re-evaluation decision and the Regulations, leading to confusion among stakeholders and the general public.
Regulatory analysis
Benefits and costs
Cost-benefit statement monetized benefits
Qualitative impacts
The PCPA (sections 8 and 21) permits the Minister to specify any conditions necessary, including conditions relating to labelling, on a registered pest control product to ensure that their health and environmental risks are acceptable when used in accordance with its conditions of registration, including conditions relating to the label. The PCPA (section 6) prohibits, among other things, the manufacture, distribution and use of a registered pest control product in a manner that is not compliant with its conditions of registration, including conditions relating to labelling. Therefore, stakeholders would be required to make the necessary label changes even without this regulatory amendment, as it is required by the re-evaluation decision. The regulatory amendment will ensure that the PCPR remains consistent with the new labelling requirements outlined in the re-evaluation decision. Given this and given that the baseline scenario already involves a change in labelling requirements, it is not anticipated that these amendments will have any costs. Minor qualitative benefits arise out of the avoidance of confusion that may result if separate labelling requirements exist in the PCPR and RVD2023-14.
Small business lens
Analysis under the small business lens concluded that the regulation will not impact Canadian small businesses.
One-for-one rule
The one-for-one rule does not apply, as there is no impact on business.
Regulatory cooperation and alignment
These amendments are not linked to any international agreements or obligations and are not part of an existing formal regulatory cooperation initiative. Several other jurisdictions, including the United States, European Union and Australia, have requirements around the labelling of products containing sodium hypochlorite and calcium hypochlorite that are similar in nature to the new labelling requirements that have been set forth in the August 2023 re-evaluation decision. Canada’s international trade in these substances is negligible, with the United States being the largest trading partner. Therefore, the minor differences in labelling requirements that do exist between Canada and its trading partners are not likely to have significant effects in terms of trade or regulatory alignment.
Effects on the environment
These amendments underwent a preliminary scan for a Strategic Environmental Assessment. Due to the nature of this proposal, it was concluded that it is not likely to have any significant environmental impacts, either positive or negative.
Gender-based analysis plus
It is not expected that these amendments will affect any groups disproportionately based on factors such as age, gender or other identity factors.
Implementation, compliance and enforcement, and service standards
Implementation
These regulatory amendments will come into force upon registration. No implementation plan or additional guidance will be needed, as the implementation of new labelling requirements is already taking place as a result of the re-evaluation decision RVD2023-14.
Contact
Jordan Hancey
Director
Policy and Regulatory Affairs
Policy and Operations Directorate
Regulatory Affairs and Applied Analysis Section
Pest Management Regulatory Agency
Health Canada
2 Constellation Drive
Ottawa, Ontario
K1A 0K9
Telephone: 613‑302‑3886
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca