Canada Gazette, Part I, Volume 156, Number 14: Regulations Amending the Pest Control Products Regulations (Applications and Imports)

April 2, 2022

Statutory authority
Pest Control Products Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Following a comprehensive review of the Pest Control Products Regulations (PCPR), Health Canada has identified a number of elements of the PCPR that could benefit from modernization.

More precisely:

Background

The Minister of Health’s primary mandate under the Pest Control Products Act (the PCPA) is to prevent unacceptable risks to individuals and the environment from the use of pest control products. The PCPA requires that the Minister of Health, to meet this objective, conduct premarket assessments of pest control products to determine if the risks to human health and the environment are acceptable and the products have acceptable value. The PCPA also allows regulations to be made that authorize the import, manufacture, distribution or use of unregistered pest control products, based on specified conditions.

In January 2016, Health Canada’s Pest Management Regulatory Agency (PMRA) launched a comprehensive review of the PCPR, the first such review since the Regulations came into force in 2006. The review is aimed at modernizing the PCPR and ensuring they continue to meet program objectives (for example health and environmental protection) in an effective and efficient manner, while attempting to minimize the regulatory burden on regulated parties.

Moreover, the SJCSR has identified an issue with the wording of the PCPR with respect to container labelling.

This regulatory proposal consolidates 13 issues either identified through the PMRA’s comprehensive review or raised by the SJCSR, and would amend certain application and importation requirements for pest control products in Canada.

Objective

While maintaining health and environmental protection, the proposed amendments would

Description

To address the issues identified, the proposed amendments would streamline some aspects of the PCPR.

Streamlining regulatory or administrative burden

The measures to streamline the regulatory or administrative burden are outlined below.

Streamlining requirements for certain manufacturing site information

Manufacture is defined in the PCPA as “[including] produce, formulate, package, label and prepare for distribution or use.” Furthermore, paragraph 6(1)(b) of the PCPR requires registrants and applicants to provide information on manufacturing sites for their pest control products and to provide updates about the sites should the sites change. Registrants have noted challenges with efficiently meeting these requirements in circumstances where a product is packaged or labelled at several sites. For example, if the packaging site of a product changes on a regular basis, the registrant must apply to amend the registration of their product every time. Since manufacturing site information is not always pertinent to the product’s evaluation, the constant updates may pose an unnecessary regulatory burden.

Health Canada proposes to remove the requirement for registrants and applicants to provide the names and addresses of certain places of manufacture on an application to register or amend the registration of a pest control product.

Instead of providing this information when applying to register or amend the registration of a pest control product, registrants and applicants of pest control products that are not microbial agents would be required to keep records pertaining to all manufacturing sites not provided, meaning the names and addresses of every place that a given pest control product is (or has been) packaged, labelled, or prepared for distribution or use. These records must be kept for five years, starting from, as applicable, the date the product was registered, the date the product’s registration was renewed, or the date the site changed.

Streamlining requirements for certain formulant supplier information

The PCPA defines a formulant as “any component of a pest control product that is added intentionally to the product and that is not an active ingredient.” Examples of formulants include flavourings used in baits (such as “bacon flavouring”) and compounds that adjust the solubility of the product (such as ethanol).

Paragraph 6(1)(h) of the PCPR requires applicants and registrants to provide information on the formulants contained in their pest control products, including the name and address of the supplier of each formulant, when applying to register or amend the registration of a pest control product. Registrants have noted challenges in efficiently meeting the requirement to provide the names and addresses of the suppliers of each formulant in circumstances where the formulant supplier changes often. For example, if a product uses a commodity formulant that can be sourced from any number of suppliers, the registrant must apply to amend the registration of their product every time they use a different supplier for a production run. Since formulant supplier information is not always pertinent to the product’s evaluation, the constant updates may pose an unnecessary regulatory burden.

Health Canada proposes to remove the requirement for registrants and applicants to provide the names and address of formulant suppliers on an application to register or amend the registration of a pest control product.

Instead of providing this information when applying to register or amend the registration of a pest control product, registrants and applicants of pest control products would be required to keep records pertaining to the names and addresses of their formulant suppliers. These records must be kept for five years, starting from, as applicable, the date the product was registered, the date the product’s registration was renewed, or the date the supplier changed.

Permitting extended validity periods for certain emergency registrations

Section 18 of the PCPR currently allows for products to be registered, or have an existing registration amended, for “the emergency control of a seriously detrimental infestation.” In these cases, “the validity period must not be longer than one year and may not be extended,” and “the registration may not be renewed.” Provincial partners have indicated that single-year validity poses challenges in certain situations, such as those involving products intended to address issues pertaining to aquatic invasive species. Many situations can be identified at the onset as requiring multiple years to be addressed. If a situation is known to require multiple years to be addressed, an additional regulatory and administrative burden may be carried from resubmitting substantively similar information with incremental updates each year.

Health Canada proposes to amend the PCPR to allow a maximum validity for emergency registrations of up to three years, rather than up to one year.

Technical issues

The measures to address technical issues are outlined below.

Addressing an issue with the definition of “seed”

The term “seed” in the PCPR is defined as “a generative part of a plant that is used for propagation purposes. It includes true seeds, seed-like fruits, bulbs, tubers and corms but does not include whole plants or cuttings.” This definition contains a redundancy: a definition that is structured with “includes” is intended to provide clarity on what could be ambiguous in the defined term. Since “true seeds” are clearly “seeds,” an “includes” definition need not mention “true seeds.”

Health Canada proposes to amend the definition of “seed” to remove the reference to “true seed.”

Addressing non-formulated pest control products

The PCPA defines a “pest control product” as “a product, an organism or a substance, including a product, an organism or a substance derived through biotechnology, that consists of its active ingredient, formulants and contaminants…” As noted previously, a formulant is further defined in the PCPA as “any component of a pest control product that is added intentionally to the product and that is not an active ingredient.”

While the majority of pest control products regulated under the PCPA contain formulants, a small subset of these products consists only of their active ingredient, meaning no formulants have been added. While products manufactured with only active ingredients can pose health and environmental risks, are regulated under the PCPA, and are registered as pest control products, there is some ambiguity as to whether they fall under the definition of pest control product of the PCPA.

Health Canada proposes to codify current practice by amending section 2 of the PCPR to prescribe that active ingredients are pest control products that are “manufactured, represented, distributed or used to directly or indirectly control, destroy, attract or repel a pest or to mitigate or prevent the injurious, noxious or troublesome effects of a pest.” This would remove any ambiguity about whether pest control products that contain only active ingredients fit the definition of “pest control product” in the PCPA.

Codifying current practice regarding electronic document delivery

Currently, most registrants and applicants provide electronic documents (labels, statements of product specification, incident reports, etc.) to Health Canada through a secure web portal. Subsection 62(1) of the PCPA requires documents to be delivered “by any method that provides proof of delivery,” or by any method that is set out in regulation. However, sending documents electronically is not considered a method that provides proof of delivery, regardless of whether the documents are sent via the secure web portal.

Health Canada proposes to codify current practice by amending the PCPR to prescribe electronic document delivery as acceptable, both for communication from regulated parties to Health Canada and vice versa. For greater certainty, Health Canada proposes to establish provisions in the regulations that outline what date and time a given communication is presumed to have been sent or received, based on such identifying information as confirmation pages or associated metadata.

Repealing a duplicative provision concerning impurities

Section 19 of the PCPR establishes a limit on the permissible amount of a single impurity, N-nitrosodi-n-propylamine (NDPA), in pest control products containing the herbicidal active ingredient trifluralin. NDPA is a member of a class of chemical called nitrosamines. Nitrosamines are a by-product of the chemical synthesis of certain compounds, including pest control products, and exposure to them can result in health impacts. The PMRA already takes levels of this impurity, and other impurities of toxicological concern, into consideration when evaluating the health and environmental risk of a pest control product, meaning that the established limit in section 19 is unnecessary.

Health Canada proposes to repeal section 19 of the PCPR.

Addressing a concern of the SJCSR

Where a pest control product is stored in a railway tank car or a transport truck tanker-trailer, or one of those containers is being used to dispense the product directly, paragraph 31(2)(b) of the PCPR requires that the mandated health and safety documents be affixed “near the control valve that is being used for distributing or dispensing the product.” The SJCSR has noted that requiring something be “near” is vague and should be expressed more clearly, for example, whether the documents must be within reach of the person operating the control valve.

Health Canada proposes to amend paragraph 31(2)(b) to clarify that the mandated health and safety documents must be affixed “within reach of the person operating the control valve.”

Codifying processes in the Pest Control Products Regulations

The measures to address process clarity are outlined below.

Clarifying current regulatory requirements for treated articles and establishing criteria for authorizing certain treated articles

Products treated with a pest control product, to directly or indirectly control, destroy or repel a pest or for mitigating or preventing its injurious, noxious or troublesome effects, meet the definition of a pest control product and, as such, are subject to the PCPA. These products are commonly referred to as “treated articles.” Articles can be treated with pest control products such as antimicrobials (for example textiles treated with a preservative), insecticides (for example insecticide-treated clothing), and herbicides (for example herbicide-treated landscape fabric).

The PCPA does not define “treated article.” However, the terminology has been used in industry and by regulators for some time. Stakeholders had been asking for published information on the regulation of treated articles, as the PMRA had been communicating regulatory guidance on a case-by-case basis.

In 2018, the PMRA published an Information Note on treated articles to broadly communicate treated article regulatory guidance to stakeholders. The Information Note also stated that articles treated with antimicrobial preservatives were exempt from registration when certain conditions are met:

These registration exemption conditions should be established in the PCPR rather than through the Information Note. This would provide regulatory clarity for stakeholders. Including a definition for treated article in the PCPR would further clarify the exemption and modernize the regulatory framework.

Health Canada proposes to amend the PCPR to remove the word “article” from the definition of “device” and then explicitly define and prescribe a “treated article” as a pest control product. Furthermore, Health Canada proposes that articles treated with antimicrobial material preservatives would be authorized under the Regulations (meaning they would not have to be registered) if they meet the following conditions:

Codifying current practice by exempting certain antimicrobials used in products that are regulated under certain Acts

Antimicrobial preservatives are pest control products that are used to extend the durability or shelf life of an article or material, by controlling micro-organisms that may degrade or damage that item (preservation). Treating an item with an antimicrobial used for preservation is thus intended to make the item last longer, which is a desired quality for many consumers. Many items are treated with a pest control product (such as an antimicrobial used for preservation) during their manufacturing stage. In many cases, the final product is regulated under federal legislation other than the PCPA, which means that certain items containing an antimicrobial preservative are already evaluated for similar health and environmental outcomes as would be required by the PCPA. Health Canada has used enforcement discretion and not enforced the PCPA for antimicrobial preservatives when they are used to treat products that are regulated under any of the Food and Drugs Act, the Feeds Act, or the Fertilizers Act. These Acts have existing and established premarket and/or post-market review requirements, which include the assessment of material preservatives used in the end-use products they regulate. To require material preservatives used in these products to be reviewed and registered by the PMRA would be a duplication of efforts by the Government as well as an administrative burden to industry.

Health Canada proposes to codify current practice by amending subsection 3(1) of the PCPR to exempt antimicrobials used for preservation from the application of the PCPA, when those antimicrobials are used in treated articles regulated under any of the Food and Drugs Act, Feeds Act or Fertilizers Act. The treated article itself would also be exempted from the application of the PCPA. This exemption would only apply to the use of those antimicrobials in or on the treated articles regulated under those Acts, and would not apply to additional uses of the antimicrobial preservative outside the scope of the Food and Drugs Act, Feeds Act or Fertilizers Act (i.e. any additional uses of the antimicrobial preservative would require registration under the PCPA).

For example, consider a hypothetical pest control product, Antimicrobial X. Antimicrobial X is used in a fertilizer. It is reviewed under the Fertilizers Act during the product assessment and does not require to also be reviewed under the PCPA when used in a fertilizer. If Antimicrobial X were also used in a can of paint, then the use in paint would be subject to the PCPA, and Antimicrobial X would require registration under the PCPA for that use. Paint is not regulated under one of the three prescribed Acts, so there is no duplication of review.

Codifying current practice by exempting certain food additives regulated under the Food and Drugs Act

Food additives are regulated in Canada under the Food and Drugs Act, with marketing authorizations made under that Act being used to exempt certain products from the prohibitions found in either the Food and Drugs Act or the Food and Drug Regulations. More than 150 pest control product formulations contain food additives as preservatives, such as rodenticides (e.g. bait) that contain calcium propionate as a mould inhibitor or insecticides (e.g. personal insect repellants) that contain benzoic acid as an oxidation inhibitor.

Health Canada’s List of Permitted Preservatives (“List 11”) is a document incorporated by reference in the Marketing Authorization for Food Additives That May Be Used as Preservatives. List 11 sets out food additives authorized to be used to control micro-organisms or oxidation in food, and their conditions of use. Part 2 and Part 3 of List 11 set out permitted food preservatives that control antibacterial or antifungal micro-organisms, respectively (meaning that they are pest control products).

Section 6.3.3 of PMRA’s formulants policy (DIR2006-02, “Formulants Policy and Implementation Guidance Document”) states that “[c]onsideration will be given to waiving the requirement for registration of preservatives that are already regulated as food additives under the Canadian Food and Drugs Act where the levels of exposure from pest control products are consistent with the levels of exposure as food additives.” While the PMRA regulates formulation preservatives, to avoid regulatory duplication, the PMRA has not regulated formulation preservatives that are on List 11, as such products have already been evaluated under the Food and Drugs Act and are approved only if the health risk is determined to be acceptable. Given that the PMRA has been consistently waiving the requirement to register these preservatives, this exemption is best placed in the Regulations and not enacted through policy.

Health Canada proposes to codify current practice by amending subsection 4(1) of the PCPR to authorize Class 2 (antibacterial) and Class 3 (antifungal) substances on List 11 (meaning they would not have to be registered). This authorization would apply when a permitted food additive is used in a pest control product.

Health Canada’s “A Guide for the Preparation of Submissions on Food Additives” lays out instructions on how a petitioner can make a submission to modify the Lists of Permitted Food Additives, including information requirements. Proposals to amend the Lists of Permitted Food Additives, whether initiated by the Government of Canada or at the request of a petitioner, are subject to a notification and comment period. This comment period includes both domestic consultation and a parallel World Trade Organization notification, to inform member countries of the proposal and allow for their comments as well.

Supporting Canada’s commitment to meeting its obligations in multilateral environmental agreements

Canada has ratified several international agreements that have obligations to prohibit the use of certain chemicals. For example, Canada is a Party to the Stockholm Convention on Persistent Organic Pollutants, and Cabinet makes individual ratification decisions on prohibiting chemicals listed under the Convention. For example, the Stockholm Convention prohibits the use of lindane, among other things. Lindane was determined likely to lead to significant adverse human health and environmental effects, in consideration of its potential for persistence, bioaccumulation, long-range environmental transport and adverse effects, such that global action was warranted. As a result, Canada ratified the prohibition of lindane on April 4, 2011.

Despite the prohibition of the use of certain chemicals imposed by the Stockholm Convention, the PMRA is required by the PCPA to evaluate applications to register products that are or contain such prohibited substances as active ingredients, and can only deny the registration based on the outcome of the evaluation (i.e. the fact the substance is included in the international agreement itself is insufficient). However, if such a product is already registered, or is registered as a result of such an application, Section 27 of the PCPA allows the Governor in Council to cancel the registration of that pest control product, if necessary, to implement Canada’s international obligations. The PMRA participates in the process by which substances are ratified under the Stockholm Convention. Products being submitted for registration under the PCPA could contain active ingredients that Canada has agreed to prohibit under the Stockholm Convention. Having the PMRA evaluate such applications may pose unnecessary regulatory and administrative burden or duplication, both for the Government of Canada and for applicants submitting products for registration. While the PMRA has not received an application to assess and register a pest control product in which the active ingredient is or contains a prohibited chemical, it may be unclear to stakeholders what substances are or are not permitted to be in pest control products.

Health Canada proposes to amend the Regulations to provide the ability to deny an application pertaining to a product that is or contains an active ingredient that Canada has, through the ratification process, agreed to prohibit pursuant to the Stockholm Convention on Persistent Organic Pollutants.

Aligning import declaration requirements with current information-collection practices

Section 36 of the PCPR requires importers of pest control products to declare their imports, and describes the information that must be declared. This is primarily done in collaboration with the Canada Border Services Agency (CBSA), which monitors the importation of pest control products, with Health Canada being engaged for admissibility decisions as needed. The information on imports that the CBSA collects at the border is more extensive than that currently required by Health Canada, and is of value to Health Canada for regulatory oversight and policy development.

Section 36 of the PCPR also currently requires importers to declare the purpose of the importation:

The PCPA contains specific prohibitions against the manufacture, possession, handling, storage, transportation, importation, distribution or use of a pest control product that is not registered or otherwise authorized under the Act or Regulations. The term “resale” does not reflect the terms used in the PCPA. The term “distribute” would be more accurate in this case, as it is defined in the PCPA as “distribute in any way, whether or not for consideration, and includes sell, offer for sale or distribution, and expose, display or advertise for sale or distribution.” In order to better align the wording in the PCPR with the wording in the PCPA, Health Canada proposes to amend section 36 to note the ability to declare an importation for the purpose of “distribution, including sale,” rather than for “resale.”

In addition, Health Canada proposes to codify current practice by amending section 36 of the PCPR to align Health Canada’s pest control product import declaration requirements with the information already collected at the border by the CBSA. This would include removing the existing exemption from declaration requirements for importation done under a foreign product use certificate, as the CBSA collects such information regardless. In total, the following declaration requirements would be added or changed:

Health Canada also proposes to codify current practice by exempting authorized treated articles from import declarations. For details on the proposed change in respect of those treated articles, see the earlier heading “Clarifying current regulatory requirements for treated articles and establishing criteria for authorizing certain treated articles.”

Finally, because treated seeds have specific information requirements that do not consistently align with how the information requirements are described in subsection 36(1) of the PCPR, for greater clarity, Health Canada proposes to lay out the information requirements for treated seed in a separate subsection 36(2). The requirements would be similar to those in subsection 36(1), but would include providing the name of the kind or species of seed and the country where the crop from which the seed is derived was grown.

Regulatory development

Consultation

The PMRA has conducted two regulatory pre-consultations on the items that would be addressed by the proposed amendments.

On November 30, 2018, the PMRA published a regulatory pre-consultation discussion paper, the summary of which is available online [Regulatory Proposal PRO2018-03, Pre-Consultation – Proposed Amendments to the Pest Control Products Regulations (Product Exemptions)]. This paper proposed amendments that would address issues that included those for treated articles. The consultation period lasted 90 days.

On October 28, 2020, the PMRA sent industry stakeholders, non-governmental organizations, Indigenous organizations, and federal/provincial/territorial partners a regulatory pre-consultation discussion paper entitled Pre-Consultation – Proposed Amendments to the Pest Control Products Regulations (Applications and Imports). This paper proposed amendments for most of the remaining issues — it did not include the issue identified by the SJCSR or the minor issue with the definition of seed — and requested feedback on costing information that would inform the cost-benefit analysis. The consultation period lasted 75 days.

The PMRA received 9 comments related to treated articles during the course of the first consultation, and 17 comments from 16 stakeholders during the course of the second.

Overall, stakeholders are supportive of the proposed changes, as most proposed changes are intended to address their concerns or were specifically requested by them. The CBSA, other federal departments, and provincial/territorial partners were also supportive, as the proposed amendments would minimize regulatory duplication.

Some commenters noted a desire to have a transition period between final publication and coming into force, so that their member companies could have adequate time to make any necessary changes to business practices. The PMRA is proposing to provide a transition period of 180 days before the coming into force of the regulations, to give industry the sufficient opportunity to familiarize themselves with the amendments and adapt business practices if required.

A commenter representing an industry organization further noted that they believed this proposal did not go far enough in its exemptions; specifically, they noted their opinion that treated articles should not be considered pest control products, and asked for additional exemptions for more classes of products, such as those regulated under the Canada Consumer Product Safety Act. No changes were made to the proposal as a result of this comment: the PMRA has maintained that treated articles are pest control products, as the articles meet the criteria to be regulated under the PCPA. They are manufactured or distributed to control or mitigate the troublesome effects of various pests on the article. The exemption criteria being proposed take into consideration whether the pesticidal component of the treated article (or chemical itself) is evaluated under other regulatory frameworks. They are designed to prevent potential regulatory gaps, such as a situation where an unevaluated antimicrobial chemical would not be evaluated under any regime due to the establishment of exemption criteria in the PCPR.

Moreover, the criteria under which treated articles would not have to be registered (i.e. they would be authorized) is not codified in the current PCPR. As a result, the proposed amendment is necessary in order to properly establish those criteria. The proposed amendments do not pose any additional burden over current practice.

Lastly, an industry stakeholder noted if authorized antimicrobial treated articles were to be subject to the import declaration requirements, then it would pose a considerable administrative and compliance burden on both industry and government, and it would dilute the effectiveness of notifications for pesticide products. Therefore, they recommended that import declaration requirements only apply to registered pest control products. The PMRA concurs, as this would codify current practice, and has incorporated this recommendation into the proposal.

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

For each issue that would be addressed by the proposed amendments, an analysis was performed to evaluate whether the baseline scenario (no action), a change to policy, or a regulatory amendment would be the best option. In each instance, the issue would be best addressed by a regulatory amendment, as the baseline scenario would not address the issue identified and an exclusively policy-level approach would not be consistent with obligations under the PCPA and the PCPR.

Regulatory analysis

Benefits and costs

In order to analyze the benefits and costs associated with the proposed amendments, Health Canada examined internal data, and conducted a costing survey with industry stakeholders in conjunction with the pre-consultation process in October 2020.

In particular, Health Canada obtained information on the record-keeping practices of registrants and applicants, the amount of time it takes to apply to amend information about a registration’s manufacturing site or formulant supplier, the amount of time it takes to prepare and submit an application for an emergency registration, and the type of staff who perform each of those activities. Wage rates were based on data in the Statistics Canada 2018 Labour Force Survey.

The costing survey informed Health Canada’s key assumptions that were used for data analysis.

Overall, it is anticipated that the proposed amendments would reduce the administrative burden on registrants and applicants, and that registrants and applicants would assume negligible compliance costs while becoming familiar with the amended regulations. In addition, it is estimated that the costs to Government to implement the proposed regulatory amendment would not be significant.

Reduction of regulatory and administrative burden

The following proposed regulatory amendments are anticipated to reduce the regulatory and administrative burden on registrants and applicants.

Streamlining requirements for certain manufacturing site information

It is anticipated that the proposed amendments would reduce the regulatory and administrative burden on regulated parties due to the reduction in time and effort required to collect, process, and complete forms, and report on changes about manufacturing sites. While the proposed amendments would institute record-keeping requirements that currently do not exist, most registrants and applicants indicated that they already keep and retain records pertaining to manufacturing sites as a component of standard business practices.

Streamlining requirements for certain formulant supplier information

It is anticipated that the proposed amendments would reduce the regulatory and administrative burden on regulated parties due to the reduction in time and effort required to collect, process, and complete forms, and report on changes about formulant suppliers. While the proposed amendments would institute record-keeping requirements that currently do not exist, most registrants and applicants indicated that they already keep and retain records pertaining to formulant suppliers as a component of standard business practices.

Permitting extended validity periods for certain emergency registrations

It is anticipated that the proposed amendments would reduce regulatory compliance costs for certain regulated parties due to the reduction in time and effort required to collect, process, and complete forms, and submit information pertaining to emergency registrations.

Proposed amendments without incremental impact on stakeholders

The following proposed amendments are anticipated to have no incremental impact on stakeholders.

Addressing an issue with the definition of “seed”

This proposed amendment is a non-substantive amendment to eliminate the redundancy in the definition of “seed” by removing the already clearly defined term “true seed” from a list of other examples of “seed.” Therefore, it is not expected to have an impact on stakeholders.

Addressing non-formulated pest control products

At this time, the PMRA regulates approximately 50 pest control products that consist of only their active ingredient (without added formulants). This amendment provides greater clarity that non-formulated products are adequately captured in the definition of “pest control product” in subsection 2(1) of the PCPA. It is anticipated that this proposed amendment will not result in any change to current business practices and will therefore have no impact on stakeholders.

Codifying current practice regarding electronic document delivery

Currently, the majority of registrants and applicants already use the secure web portal for electronic document delivery. Others who cannot or who choose not to use the portal use regular mail to deliver documents. Prescribing in the PCPR that electronic document delivery be one of the acceptable methods would not result in any change to current business practices and will therefore have no impact on stakeholders.

Repealing a duplicative provision concerning impurities

Section 19 of the PCPR establishes a limit on the permissible amount of a single impurity (N-nitrosidi-n-propylamine) in pest control products containing trifluralin. Currently, as a normal practice, this impurity is taken into consideration during the health and environmental evaluation process of the products, with or without section 19 of the PCPR. Removing this duplicative requirement would neither have an impact on stakeholders nor cause negative implications for health and environmental protection.

Addressing a concern of the SJCSR

This proposed amendment is considered a non-substantive amendment that would provide further clarification on how to affix the health and safety documents (from the current wording of “near the control valve that is being used for distributing or dispensing the product” to the proposed wording of “within reach of the person operating the discharge control valve”). It is expected that this amendment would not have an impact on stakeholders.

Codifying current practice by exempting certain antimicrobials used in products that are regulated under certain Acts

Currently, the PMRA does not require registration of antimicrobial preservatives for use in or on products regulated under the Food and Drugs Act, the Feeds Act or the Fertilizers Act. These Acts have existing premarket and/or post-market review processes in place to assess the antimicrobial preservatives used in or on the end-use products they regulate. Exempting these products from the application of the PCPA would not result in changes to current practice and is not expected to have an impact on stakeholders.

Codifying current practice regarding certain food additives regulated under the Food and Drugs Act

To date, the PMRA has not required the registration of formulation preservatives that are regulated as food additives under the Food and Drugs Act. Authorizing antibacterial (Class 2) and antifungal (Class 3) substances on “List 11” would not be a change to current practice and would not have an impact on stakeholders.

Supporting Canada’s commitment to meeting its obligations in multilateral environmental agreements

To date, the PMRA has not received an application to register a pest control product where the active ingredient is or contains a chemical substance that Canada has, through the ratification process, agreed to prohibit under the Stockholm Convention on Persistent Organic Pollutants. It is expected that, with or without this proposed change, the PMRA would not be approached with such an application. It is expected that this proposed amendment will have no impact on stakeholders.

In the unlikely event that an application to register includes one of the active ingredients prohibited under the Stockholm Convention, this proposed amendment would save Health Canada from expending resources to conduct an evaluation that would end up in the denial of the application. This amendment also allows for better alignment of PMRA processes prescribed by regulation with Canada’s international obligations under the Stockholm Convention for those active ingredients whose prohibition Canada has ratified.

The Government of Canada would provide guidance, if needed, to assist registrants and applicants in determining whether a given chemical may be subject to a prohibition or ban, or if a given chemical is subject to a critical use exemption under the Stockholm Convention.

Aligning import declaration requirements with current information-collection practices

Section 36 of the PCPR requires importers to declare their pest control product imports. This is primarily done in collaboration with the CBSA, which collects import declaration information at the border. The current information collected by the CBSA is more extensive than that required by the PCPR. Moreover, the CBSA requires declarations for products imported under a foreign product use certificate, even though these products are currently exempted from section 36 declaration requirements in the PCPR. This proposal would align import declaration requirements in the PCPR with the current information-collection practices of the CBSA. The proposal would also remove the declaration exemption of products under a foreign product use certificate in the PCPR.

Aligning the import declaration requirements of the PCPR with existing CBSA import declaration processes should not result in any significant change to current business practices. This amendment would therefore have negligible to no impact on stakeholders.

Proposed amendment with possible, minor compliance costs for stakeholders

The following proposed amendment may result in minor compliance costs to stakeholders while they familiarize themselves with the change

Clarifying current regulatory requirements for treated articles and establishing criteria for authorizing certain treated articles

Treated articles are pest control products and subject to the PCPA and the PCPR. As indicated in the Information Note on treated articles, some antimicrobial treated articles will not have to be registered (i.e. they will be authorized under the Regulations) if they meet the criteria. While the proposal would codify the existing approach, some regulated parties (e.g. importers who are bringing in products from foreign countries to Canada) might have to verify whether their products meet the conditions for authorization. It is anticipated that these businesses would have to spend an average of one hour familiarizing themselves with the authorization conditions before this proposal comes into force.

The PMRA intends to provide a transition period before the coming into force of the proposed Regulations to give industry stakeholders sufficient time to familiarize themselves with the amendments and adapt business practices, if required. It is anticipated that the related compliance cost would be minimal.

Of note, treated articles that are authorized under the Regulations would not be subject to the import declaration requirements. Therefore, this proposal would not impose an additional administrative burden on stakeholders.

Government implementation costs

It is anticipated that the Government of Canada would need to spend time and resources in modifying electronic forms (e.g. the Statement of Product Specification Form) and providing interpretive guidance (e.g. extending the validity period for emergency registration) to potential applicants. The implementation costs are not anticipated to be significant and will be absorbed by Health Canada.

Small business lens

It is anticipated that the proposed regulatory amendment would not impose incremental administrative burden, but would result in cost savings in both reducing administrative and compliance costs to the registrants and applicants. Based on research conducted by PMRA in collaboration with Statistics Canada in 2018, it is estimated that about 80% of registrants are small businesses. In addition, based on PMRA’s administrative data, it is estimated that the proposed changes would have impact on about 219 businesses in total. Therefore, it is reasonable to assume that the proposed amendments would result in net reduction of administrative burden on approximately 175 small businesses. Under the existing regulations, small businesses are required to spend time and resources in processing and submitting information to PMRA on the product packaging and labelling sites and formulant suppliers, and to provide updates through submitting notifications to PMRA every time the packaging/labelling sites or formulant suppliers are changed. That research also indicates that small businesses have lower gross operating margins than larger registrants. It is expected that small registrants would improve their bottom line to a larger extent than those larger firms would see by reducing administrative burden after the proposed amendments are implemented.

There could be some compliance costs associated with small businesses familiarizing themselves with the changes; however, these costs are expected to be negligible. It is assumed that it would take an average of one hour for a person to get familiarized with the authorization criteria for the treated articles subject to the proposal.

One-for-one rule

The proposed amendments are expected to decrease administrative costs for registrants. Therefore, the one-for-one rule applies and the proposal is considered an “OUT” under the rule. The total annualized administrative cost savings for all regulated parties are estimated to be $138,130, or approximately $609 per regulated party (based on 2012 constant dollar).

This reduction would be a result of registrants and applicants no longer having to provide and update information on manufacturing sites and formulant suppliers on a regular basis.

Key assumptions

Regulatory cooperation and alignment

The proposed amendments would support Canada’s commitment to meeting its obligations under the Stockholm Convention on Persistent Organic Pollutants, and reduce the potential for misalignment in the future, by making it possible to deny applications outright for products that are or contain prohibited active ingredients.

Where possible, environmental scans have been performed to explore whether the proposed amendments would align with the approaches taken by other jurisdictions or international organizations. No impacts due to misalignments between the proposed approach and those of other jurisdictions or international organizations have been identified or are anticipated. For example:

Streamlining requirements for certain manufacturing site information

The United States Environmental Protection Agency (U.S. EPA) requires every site that manufactures, formulates, packages, repackages or labels a pesticide to have a U.S. EPA establishment number. Each establishment is required to provide a yearly report of their activities and the product label will have the establishment number printed on it.

There are some 15 000 establishments worldwide. The sheer volume of establishments that are registered and tracked can pose challenges when managing specification form changes. The proposed amendments are consistent with the U.S. approach, and would pose less administrative burden than the current U.S. system, as reporting would only be required upon request.

Streamlining requirements for certain formulant supplier information

The U.S. EPA regulates formulants (known as “inert ingredients” or “inerts” in the U.S. system) very similarly to how Canada regulates them. The registration process at the U.S. EPA requires registrants to provide information on suppliers of inert materials, similar to the current Canadian process. Certain inerts, however, are considered “commodity chemicals”, with a list of commodity chemicals being maintained on the U.S. EPA web page. Registrants do not have to provide information about suppliers of commodity chemicals; instead, they are required to keep records pertaining to the suppliers of a given commodity chemical.

The proposed amendments to remove requirements for formulant suppliers would align with the current U.S. requirement for commodity chemicals, and would reduce administrative burden even further by removing the requirement for all formulants, not just those considered commodity chemicals.

Permitting extended validity periods for certain emergency registrations

Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes the U.S. EPA to allow emergency exemptions for unregistered uses of pesticides to address emergency conditions. Under such an exemption, the U.S. EPA allows limited use of the pesticide in defined geographic areas for a finite period of time once the U.S. EPA confirms that the situation meets the statutory definition of “emergency condition.” As a result, the U.S. EPA may exempt any federal or state agency, at their request, from any part of FIFRA when a serious pest problem jeopardizes production of agricultural goods or public health. No pesticides are currently registered for that situation. Similar to this proposed amendment, the U.S. EPA may authorize a maximum three-year exemption. Three-year exemptions are used to control the introduction or spread of any pest that is an invasive species or not known to be widely prevalent or distributed within the United States and its territories.

Article 53 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC provides the regulatory framework for emergency registrations in the EU in situations where it “appears necessary because of a danger which cannot be contained by any other reasonable means.” Authorizations last for 120 days, but can be extended or repeated. As a result, the three-year validity that would be permitted by the proposed amendment would surpass the 120-day maximum validity period permitted by the European Union and the Council, noting that the EU regulatory framework could be extended such that it could equal that of the proposal.

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 this proposal.

Implementation, compliance and enforcement, and service standards

Implementation

To provide registrants and applicants with time to adjust to the amendments, Health Canada is proposing a delayed coming into force as part of the implementation. The proposed amendments would come into force six months after the day on which they are published in the Canada Gazette, Part II. The existing Information Note on treated articles and the conditions under which articles treated with antimicrobial preservatives would not have to be registered under the regulations (i.e. authorized under the PCPA) would remain in effect until the proposed amendments come into force.

The regulatory amendments associated with this proposal may result in changes to related policies and interpretive guidance. Consistent with Health Canada’s obligations under the PCPA, consultation on those changes to policies and guidance will take place as required.

Compliance and enforcement

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 letters; detention, seizure and forfeiture of products; compliance orders under the PCPA; and notices of violation 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.

Health Canada follows an established compliance and enforcement policy for pesticides to promote and enhance fair treatment of the regulated community.

Service standards

PMRA follows established service standards, or defined timelines, for evaluating new or amended registrations as outlined in PMRA Guidance Document, Management of Submissions Policy.

Contact

Please direct all questions and inquiries to

Jordan Hancey
Policy and Operations Directorate
Pest Management Regulatory Agency
Health Canada
2720 Riverside Drive
Ottawa, Ontario
K1A 0K9
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to section 67footnote a of the Pest Control Products Act footnote b, proposes to make the annexed Regulations Amending the Pest Control Products Regulations (Applications and Imports).

Interested persons may make representations concerning the proposed Regulations within 70 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Jordan Hancey, Director, Policy and Regulatory Affairs Division, Policy and Operations Directorate, Pest Management Regulatory Agency, Department of Health, Ottawa, Ontario, Address Locator: 6607, 2720 Riverside Drive, Ottawa, Ontario, K1A 0K9 (email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca).

Ottawa, March 24, 2022

Wendy Nixon
Assistant Clerk of the Privy Council

Regulations Amending the Pest Control Products Regulations (Applications and Imports)

Amendments

1 (1) The definitions device and seed in subsection 1(1) of the Pest Control Products Regulations footnote 1 are replaced by the following:

device
means an instrument, gadget, apparatus, appliance or other similar object. (dispositif)
seed
means a generative part of a plant that is used for propagation purposes. It includes seed-like fruits, bulbs, tubers and corms but does not include whole plants or cuttings. (semence)

(2) Subsection 1(1) of the Regulations is amended by adding the following in alphabetical order:

antimicrobial preservative
means a chemical substance, or a mixture of chemical substances, that is intentionally incorporated into an article, or applied to it, for the purpose of preserving the article from deterioration or degradation by preventing the growth of micro-organisms. (agent de conservation antimicrobien)
Stockholm Convention
means the Stockholm Convention on Persistent Organic Pollutants, signed at Stockholm on May 22, 2001, as amended from time to time. (Convention de Stockholm)
treated article
means an inanimate product or substance
  • (a) that has been treated, during the manufacturing process, with a pest control product either by intentionally incorporating the product into, or applying it to, the article; and
  • (b) whose primary purpose, prior to the treatment was not, directly or indirectly, to control, destroy, attract or repel a pest or to mitigate or prevent the injurious, noxious or troublesome effects of a pest. (article traité)
treated seed
means seed that is treated with a pest control product either by intentionally incorporating the product into, or applying it to, the seed. (semence traitée)

2 Section 2 of the Regulations is amended by striking out “and” at the end of paragraph (a) and by adding the following after paragraph (b):

3 (1) The portion of paragraph 3(1)(f) of the Regulations before subparagraph (i) is replaced by the following:

(2) Subsection 3(1) of the Regulations is amended by striking out “and” at the end of paragraph (e) and by adding the following after paragraph (f):

4 Subsection 4(1) of the Regulations is amended by striking out “or” at the end of paragraph (d) and by adding the following after paragraph (e):

5 The Regulations are amended by adding the following after section 5:

Methods of Electronic Delivery

Electronic delivery

5.1 (1) For the purpose of subsection 62(1) of the Act, notices or other documents required or authorized to be delivered under the Act may be delivered electronically through the website of the Government of Canada or by another means of electronic communication.

Presumed time of delivery

(2) A notice or other document that is delivered electronically is presumed to have been delivered

When presumption may be set aside

(3) A presumption as to the date of delivery of a notice or other document may be set aside on the basis of any metadata or the data from any other tracking system that relates to the notice or other document.

6 (1) Paragraph 6(1)(b) of the Regulations is replaced by the following:

(2) Paragraph 6(1)(h) of the Regulations is replaced by the following:

7 The Regulations are amended by adding the following after section 6:

Records

7 (1) An applicant referred to under subsection 6(1) or a registrant referred to in subsection 16(1) must make a record of

Period of retention

(2) The applicant or the registrant must keep the record for five years after, as the case may be, the date of registration, its amendment or its renewal.

Change of information

(3) If the information contained in the record changes, the applicant or registrant must update the record. If an update is required, the previous record must be kept for five years after the update.

Provision of records

(4) The applicant or the registrant must provide any records to the Minister, an inspector or an analyst, on their request and within the period they specify.

Stockholm Convention — evaluations not necessary

7.1 (1) No evaluation under paragraph 7(3)(a) of the Act is necessary when

Denial of application

(2) For the purpose of subsection 8(4) of the Act, the health or environmental risks of a pest control product described in subsection (1) paragraph (1)(a) are not acceptable.

8 Paragraph 18(a) of the Regulations is replaced by the following:

9 Section 19 of the Regulations and the heading before it are repealed.

10 (1) The portion of subsection 31(2) of the French version of Regulations before paragraph (a) is replaced by the following:

Entreposage ou déchargement du produit

(2) Les documents visés au paragraphe (1) satisfont aux conditions ci-après si le produit est stocké dans le wagon-citerne ou la remorque-citerne ou est déchargé directement à partir de l’un ou de l’autre :

(2) Paragraph 31(2)(b) of the Regulations is replaced by the following:

11 Section 36 of the Regulations is replaced by the following:

Declaration — general

36 (1) Subject to subsection (2), the importer of a pest control product — except a pest control product described in paragraphs 4(1)(f) or (g) — must provide the Minister with a declaration at the time of the importation, in English or French, signed by the importer, that sets out

Declaration — treated seed

(2) The importer of treated seed must provide the Minister with a declaration at the time of the importation, in English or French, signed by the importer, that sets out

Retention

(3) The importer must keep the information set out in a declaration for two years after the importation of the pest control product in respect of which the declaration was made.

12 Section 71 of the Regulations is amended by striking out “and” at the end of paragraph (b) and by replacing paragraph (c) by the following:

Coming into Force

13 These Regulations come into force on the 180th day after the day on which they are published in the Canada Gazette, Part II.

Terms of use and Privacy notice

Terms of use

It is your responsibility to ensure that the comments you provide do not:

  • contain personal information
  • contain protected or classified information of the Government of Canada
  • express or incite discrimination on the basis of race, sex, religion, sexual orientation or against any other group protected under the Canadian Human Rights Act or the Canadian Charter of Rights and Freedoms
  • contain hateful, defamatory, or obscene language
  • contain threatening, violent, intimidating or harassing language
  • contain language contrary to any federal, provincial or territorial laws of Canada
  • constitute impersonation, advertising or spam
  • encourage or incite any criminal activity
  • contain a language other than English or French
  • otherwise violate this notice

The federal institution managing the proposed regulatory change retains the right to review and remove personal information, hate speech, or other information deemed inappropriate for public posting as listed above.

Confidential Business Information should only be posted in the specific Confidential Business Information text box. In general, Confidential Business Information includes information that (i) is not publicly available, (ii) is treated in a confidential manner by the person to whose business the information relates, and (iii) has actual or potential economic value to the person or their competitors because it is not publicly available and whose disclosure would result in financial loss to the person or a material gain to their competitors. Comments that you provide in the Confidential Business Information section that satisfy this description will not be made publicly available. The federal institution managing the proposed regulatory change retains the right to post the comment publicly if it is not deemed to be Confidential Business Information.

Your comments will be posted on the Canada Gazette website for public review. However, you have the right to submit your comments anonymously. If you choose to remain anonymous, your comments will be made public and attributed to an anonymous individual. No other information about you will be made publicly available.

Comments will remain posted on the Canada Gazette website for at least 10 years.

Please note that public email is not secure, if the attachment you wish to send contains sensitive information, please contact the departmental email to discuss ways in which you can transmit sensitive information.

Privacy notice

The information you provide is collected under the authority of the Financial Administration Act, the Department of Public Works and Government Services Act, the Canada–United States–Mexico Agreement Implementation Act,and applicable regulators’ enabling statutes for the purpose of collecting comments related to the proposed regulatory changes. Your comments and documents are collected for the purpose of increasing transparency in the regulatory process and making Government more accessible to Canadians.

Personal information submitted is collected, used, disclosed, retained, and protected from unauthorized persons and/or agencies pursuant to the provisions of the Privacy Act and the Privacy Regulations. Individual names that are submitted will not be posted online but will be kept for contact if needed. The names of organizations that submit comments will be posted online.

Submitted information, including personal information, will be accessible to Public Services and Procurement Canada, who is responsible for the Canada Gazette webpage, and the federal institution managing the proposed regulatory change.

You have the right of access to and correction of your personal information. To seek access or correction of your personal information, contact the Access to Information and Privacy (ATIP) Office of the federal institution managing the proposed regulatory change.

You have the right to file a complaint to the Privacy Commission of Canada regarding any federal institution’s handling of your personal information.

The personal information provided is included in Personal Information Bank PSU 938 Outreach Activities. Individuals requesting access to their personal information under the Privacy Act should submit their request to the appropriate regulator with sufficient information for that federal institution to retrieve their personal information. For individuals who choose to submit comments anonymously, requests for their information may not be reasonably retrievable by the government institution.