Regulations Amending the Pest Control Products Regulations (Sodium Bromide and Potassium Monopersulfate): SOR/2020-263
Canada Gazette, Part II, Volume 154, Number 26
Registration
SOR/2020-263 December 4, 2020
PEST CONTROL PRODUCTS ACT
P.C. 2020-981 December 4, 2020
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 67 footnote a of the Pest Control Products Act footnote b, makes the annexed Regulations Amending the Pest Control Products Regulations (Sodium Bromide and Potassium Monopersulfate).
Regulations Amending the Pest Control Products Regulations (Sodium Bromide and Potassium Monopersulfate)
Amendment
1 Items 4 and 5 of the table to section 8 of Schedule 2 to the Pest Control Products Regulations footnote 1 are repealed.
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 2018, the Pest Management Regulatory Agency (PMRA) of Health Canada finalized its re-evaluation of sodium bromide and concluded via the Re-evaluation Decision RVD2018-36, Sodium Bromide and Its Associated End-use Products (Re-evaluation Decision RVD2018-36) that the health risks associated with the use of sodium bromide at a 35% concentration used in conjunction with potassium monopersulfate at a 32% concentration (collectively referred to as SBPM) in spa products were not acceptable since the bromide exposure estimates were close to the levels associated with thyroid effects. Furthermore, the contribution of bromide exposure from spa uses is significant when taking into consideration background exposure levels due to bromide naturally present in foods. SBPM are active ingredients used together to control bacteria and algae in spa waters. Given that these products are not authorized products (see the Background section below) and the health concerns set out in Re-evaluation Decision RVD2018-36, regulatory amendments to the Pest Control Products Regulations (PCPR) are required to provide regulatory clarity and reflect the outcome of the re-evaluation decision.
Background
The Minister of Health’s primary mandate under the Pest Control Products Act (PCPA) is to prevent unacceptable risks to individuals and the environment from the use of pest control products. Before a pest control product can be used or sold in Canada, it must be registered or otherwise authorized under the PCPA. Products must undergo a thorough pre-market, science-based assessment by Health Canada, meet health and environmental protection standards, and have acceptable value. If the specified uses of a pest control product pose unacceptable risks to human health or the environment, it is not approved for use in Canada.
Health Canada also conducts post-market reviews of registered pest control products. Cyclical re-evaluations are conducted every 15 years to determine whether the use of these products continue to be acceptable according to current standards. Special reviews footnote 2 may be conducted when there is an aspect of concern about the product that creates reasonable grounds there may be unacceptable risk or unacceptable value, or when a country member of the Organisation for Economic Co-operation and Development (OECD) bans all uses of a product for health or environmental reasons. In all cases, the Minister of Health can decide to confirm the registration, modify it (e.g. by establishing measures to mitigate risks), or, in cases where risks are not acceptable and cannot be mitigated, cancel it.
Section 4 and Schedule 2 of the PCPR are used to exempt certain products from registration (i.e. they are “authorized”), provided the conditions set out in the PCPR are satisfied. While these products, which are generally considered lower risk, are exempt from registration, they remain regulated under the PCPA and subject to compliance and enforcement activities.
In order for a spa product to be exempt from registration under the PCPA, one of the conditions it must meet is that its active ingredient, as listed on Schedule 2, must be a registered active ingredient of the type and concentration set out in the schedule (paragraph 8(b) of Schedule 2). While SBPM (i.e. active ingredients) are listed on Schedule 2, their registrations were discontinued; therefore, spa products containing SBPM are not authorized products as they do not meet the condition set out in paragraph 8(b) of Schedule 2. In addition, they pose health risks to individuals per the Re-evaluation Decision RVD2018-36. These regulatory amendments will provide greater clarity that SBPM are not authorized products.
In 2018, PMRA finalized its re-evaluation of sodium bromide, which ultimately included all products containing sodium bromide that were registered in Canada, electrolysis devices that may be used with sodium bromide products, as well as sodium bromide used in combination with potassium monopersulfate. PMRA published the Re-evaluation Decision RVD2018-36, which concluded that the health risks associated with the use of SBPM in spa products were not acceptable since the bromide exposure estimates were close to the levels associated with thyroid effects.
Objective
Given the health concerns identified, SBPM is being removed from Schedule 2 to provide regulatory clarity that these products are not authorized. This is consistent with the objective of the PCPA, which is to prevent unacceptable risks to individuals and the environment from the use of pest control products and encourage public awareness of the status of the products.
Description
The amendments will remove sodium bromide at a 35% concentration and potassium monopersulfate at a 32% concentration from the list of spa products in Schedule 2 that, subject to certain conditions, such as the requirement that the active ingredient be registered, are exempt from registration.
Regulatory development
Consultation
In 2017, PMRA published its Proposed Re-evaluation Decision PRVD2017-10, Sodium Bromide on the Government of Canada’s website for public consultation. This proposed re-evaluation decision indicated that the health risks associated with the use of SBPM in spa products were not acceptable, since the bromide exposure estimates were close to the levels associated with thyroid effects. Due to the health risks identified, it was proposed that SBPM be removed from Schedule 2. The proposed decision was published with a 90-day comment period. No comments on the removal of SBPM were received.
Also in 2018, PMRA further consulted the public and stakeholders including industry associations and non-governmental organizations (NGOs), on a regulatory proposal to remove SBPM from the schedule. Specifically, a consultation document, entitled “Consultation on Proposed Amendments to the Pest Control Products Regulations (Product Exemptions) - Pre-Consultation, PRO2018-03,” was published on the Government of Canada’s website with a 90-day comment period. Shortly after publication, a webinar session was conducted to present the proposal to stakeholders. No comments on the proposal were received.
Given the extensive consultation that PMRA conducted and that no incremental impacts on stakeholders are expected, as the Regulations simply provide regulatory clarity that SBPM are not authorized, the Regulations were not prepublished for further consultation.
Modern treaty obligations and Indigenous engagement and consultation
No impacts have been identified in respect of the Government’s obligations in relation to Indigenous rights protected by section 35 of the Constitution Act, 1982, or its modern treaty obligations.
Instrument choice
The re-evaluation decision noted that, given the identified health risks, it is necessary to remove SBPM from Schedule 2, thereby further clarifying that the products are not authorized. As such, status quo was not recommended. The only means by which Schedule 2 can be amended is by regulatory amendment.
Regulatory analysis
Benefits and costs
Sodium bromide at a 35% concentration and potassium monopersulfate at a 32% concentration are currently not authorized, and will remain so with the coming into force of Regulations. The Regulations therefore are not expected to impose any incremental costs on stakeholders. However, the Regulations are expected to provide regulatory clarity, which will reduce the risk of these products being sold and used and the associated health risks.
Health Canada intends to conduct a marketplace promotion program after the Canada Gazette, Part II, publication to promote awareness of the regulatory changes and compliance within the spa sector as part of its annual program. Costs associated with compliance promotion are expected to be negligible.
Small business lens
The small business lens does not apply to these Regulations, as no incremental impacts on small businesses are expected.
One-for-one rule
The amendments do not impose any administrative requirements and administrative burden on stakeholders.
Regulatory cooperation and alignment
These Regulations remove SPBM from Schedule 2 to provide regulatory clarity that the products are not authorized in Canada. The Regulations support the objective of the PCPA, which is to prevent unacceptable risks to individuals and the environment from the use of pest control products.
Strategic environmental assessment
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.
Gender-based analysis plus
No gender-based analysis plus (GBA+) impacts have been identified for these Regulations.
Implementation, compliance and enforcement, and service standards
The amendments will come into force on the day they are registered. As mentioned above, Health Canada intends to conduct a marketplace promotion program after the Canada Gazette, Part II, publication to promote awareness of the regulatory changes and compliance within the spa sector as part of its annual program.
Health Canada encourages, promotes, maintains and enforces compliance with the PCPA through active prevention; inspections, including surveillance; and enforcement response actions. Active prevention aims to educate, facilitate and promote compliance as well as to communicate regulatory information. Inspections are designed to determine the level of compliance of users, distributors and registrants of pesticides with the general provisions of the PCPA and its regulations, as well as specific terms and conditions of registration.
Enforcement response may include warning letter; detention, seizure and forfeiture of products; compliance orders under the PCPA; and notices of violation (NOV) with warning or monetary penalty under the Agriculture and Agri-Food Administrative Monetary Penalties Act.
Compliance with the PCPA and its regulations is achieved through a network of officers and inspectors across Canada. Health Canada regional offices also have formal agreements with provincial pesticide regulatory departments, providing a basis to collaborate with them in inspections and in the development and delivery of compliance activities.
Contact
Brenda Tang
Policy, Communications and Regulatory Affairs Directorate
Pest Management Regulatory Agency
Health Canada
2720 Riverside Drive
Ottawa, Ontario
K1A 0K9
Email: hc.pmra.regulatory.affairs-affaires.reglementaires.arla.sc@canada.ca