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Regulatory Proposal PRO2022-01, Pre-Consultation - Proposed Regulatory Amendments to the Pest Control Products Regulations (Research)

Notice to the reader:

The online consultation is now closed.

Pest Management Regulatory Agency
16 December 2022
ISSN: 1925-122X (PDF version)
Catalogue number: H113-8/2022-1E-PDF

Summary

This page is a summary of the consultation document. If you would like to comment, please request the full consultation document.

To obtain a full copy, request Regulatory Proposal PRO2022-01, Pre-Consultation - Proposed Regulatory Amendments to the Pest Control Products Regulations (Research).

Should you require further information please contact the Pest Management Information Service.

Table of contents

  1. 1.0 Executive summary
  2. 2.0 Background
  3. 3.0 Proposed amendments
  4. 4.0 Input requested
  5. 5.0 Next steps

1.0 Executive summary

In Canada, pesticides are regulated under the Pest Control Products Act and its associated regulations, including the Pest Control Product Regulations. While pesticides must be used according to their registered label under the Pest Control Products Act, sections 46–70 of the Pest Control Product Regulations provide an exception: enabling the use of unregistered active ingredients and experimental uses of registered products for research purposes. The purpose of these sections is to allow researchers to generate test data, under acceptable conditions, that provide information on the human health and environmental effects of pesticides and their value (for example, including efficacy).

This document describes proposed amendments to the research provisions in the Pest Control Product Regulations as part of Health Canada's Pest Management Regulatory Agency's (PMRA) comprehensive review of the Pest Control Product Regulations. The proposed amendments aim to facilitate beneficial pest control product research by modernizing regulations while ensuring that research is conducted under conditions that protect human health and the environment. These proposed amendments to the research provisions vary in anticipated levels of impact to stakeholders.

In addition to the proposed amendments to the research provisions in the Pest Control Product Regulations, there may be accompanying amendments to the terminology used in Schedule 3 Item 1 of the Pest Control Products Fees and Charges Regulations. Proposed amendments to the Pest Control Products Fees and Charges Regulations do not include any changes to current fee costs for research.

It is expected that the following proposed amendments would not create regulatory burden for stakeholders:

Other proposed amendments are anticipated to reduce regulatory burden on regulated parties, namely:

The following proposed amendments may also have an effect on regulatory burden, but more information is required from regulated parties in order to quantify the nature of the effect, namely:

In order to better quantify the incremental impacts of these proposed changes, Health Canada needs to consult with stakeholders on certain aspects of their business practices. To assist in gathering the required information regarding the impacts of the proposed amendments a questionnaire has been added to the end of PRO2022-01, Pre-Consultation - Proposed Regulatory Amendments to the Pest Control Products Regulations (Research).

2.0 Background

In January 2016, the PMRA launched the first comprehensive review of the Pest Control Products Regulations since they were established in 2006. The comprehensive review takes into account both internal program evaluation, and comments received from industry stakeholders over the years.

The objective of the comprehensive review is to:

This comprehensive review includes provisions governing research with pest control products. Research is essential to the development and regulation of pest control products and forms the foundation of the scientific and technical information required to evaluate the safety and value of a product.

At the same time, the PMRA is undergoing a transformation process that is intended to: further strengthen human health and environmental protection through modernized business processes for the review of pesticides; improve transparency and public access to information and data across the regulatory pesticide processes; and increase the use of comprehensive, real-world data on water monitoring, crop production and pesticide use, as well as independent scientific advice. The proposed amendments to the research provisions support the transformation objectives by promoting beneficial pest control product research and modernizing regulations for continued human health and environmental protection.

The Pest Control Product Regulations define "research" as:

"tests that are carried out to generate test data in support of an application for registration of a pest control product or an application to amend a registration, using a pest control product that contains an unregistered active ingredient, using an unregistered pest control product that contains a registered active ingredient or using a registered pest control product in a manner or for a use that is not specified in the conditions of registration."

Sections 47 through 55 of the Pest Control Product Regulations set out the main categories of research:

Sections 59 through 70 address topics such as signage at research sites, how pest control products used in research must be labelled, what to do with unused product, and what to do with treated feed or food.

The PMRA also provides interpretive guidance to interested parties that wish to undertake research. These documents, which can be found in the Pesticides and pest management reports and publications portion of Canada.ca, would be updated to reflect the proposed amendments as they come into force:

3.0 Proposed amendments

3.1 Broadening the range of permitted research

3.1.1 Increasing the eligible studies for research

Currently, only research that is carried out to generate test data in support of an application for registration of a pest control product or an application to amend a registration is permitted under the Pest Control Product Regulations. This condition in the Pest Control Product Regulations applies to a researcher in all cases: if they apply for a research authorization, obtain confirmation of their research notification; or are exempt from the application process to conduct research in a laboratory 55(1), or outside of a laboratory under certain conditions 55(2). The purpose of research is determined by the type of test data generated (for example, an applicant will state the target pest and that efficacy, residue, toxicity, or other test data will be generated on their research authorization form). Thus, at present, research that could not support registration or amend a registration (for example, anti-cancer research using a pesticide active ingredient) does not meet the definition of research and is not permitted in the current Pest Control Product Regulations.

The proposal would amend the definition of research to include "all research conducted using pest control products", regardless if the research is intended to support or amend an application for registration. This would expand the existing framework to include research that is not aimed at registration, such as purely academic research examining health, safety or environmental impacts of pest control products, or examining the efficacy of a pesticide active ingredient for a non-pesticidal purpose. Broadening the range of permitted research will allow the PMRA to have oversight to ensure that risks to human health and safety or the environment are acceptable, while facilitating new forms of beneficial pesticide research.

This amendment would broaden the range of permitted research but does not change the existing requirements for research. It is anticipated that some newly permitted research could meet the exemption criteria and therefore would not result in additional burden. Researchers who are interested in conducting newly permitted research activities are encouraged to respond to the consultation and attached questionnaire (see Appendix I of PRO2022-01).

3.1.2 Research with devices

Currently research includes "tests that are carried out to generate test data … using a pest control product that contains an unregistered active ingredient, using an unregistered pest control product that contains a registered active ingredient or using a registered pest control product in a manner or for a use that is not specified in the conditions of registration". In the Pest Control Product Regulations, things may be prescribed to be pest control products, meaning they are subject to the Pest Control Products Act. Prescribed pest control product devices are listed in Schedule 1 of the Pest Control Product Regulations. It is possible that prescribed devices included in Schedule 1 may not contain a typical active ingredient

The proposal would amend the definition of research to include experimental uses of unregistered prescribed devices. Additionally, the proposal would require research involving a prescribed device without a chemical, semiochemical, or microbial active ingredient to obtain a research authorization, or be conducted in a laboratory. This will allow the PMRA to have oversight to ensure that risks to human health and safety or the environment are acceptable, while facilitating beneficial pesticide research.

This amendment would broaden the range of permitted research but does not change the existing requirements for other types of research. Researchers who are interested in conducting these research activities are encouraged to respond to the consultation and attached questionnaire (see Appendix I of PRO2022-01).

3.2 Proposed technical amendments with no anticipated impacts

The following proposed regulatory amendments are generally technical in nature, and are intended to codify operational policy. These amendments will ensure continued protections for human health and the environment, and it is anticipated that they would have no incremental impact on stakeholders.

3.2.1 Streamlining the regulatory text of the research provisions

Research must meet certain conditions specified by the minister. Currently, the Pest Control Product Regulations includes three different categories;

The Pest Control Product Regulations text detailing these processes is legalistic, lengthy, and repetitive; this could result in interpretation issues. Industry stakeholders have asked for clarification of provisions with respect to research notifications, the applicability of signage and labelling, as well as crop destruct. The uncertainty surrounding these provisions may be due, in part, to the structure and terminology used in the existing research provisions. For example, the provisions for research authorizations and notifications partially overlap in details on when a researcher should obtain a certificate from the minister and what types of information are required. Another example is how the research notification criteria in 53 and exempt research criteria in 55(2) repeat some of the conditions required to control risks. In contrast, the provisions for pre-market registration, found in the Pest Control Products Act and Pest Control Product Regulations, are simpler despite the greater variety of applications and information requirements.

The intent of the proposal is to simplify and clarify provisions 47 through 54 without any impacts to stakeholders.

Research authorizations and research notifications will be combined into a single application process in the regulations. The criteria for exemptions in section 55 must be prescribed in the Pest Control Product Regulations and as such they will not be removed. Applications that meet the current research notification conditions in 53 will be a "streamlined" research authorization, with its criteria specified in policy/guidance instead. Applications of this nature will keep the current fees and review times for research notifications. Other references to research authorization and research notifications found in the Pest Control Product Regulations and the Pest Control Products Fees and Charges Regulations will be updated in line with the simplified text as necessary. An updated guidance document would be available to stakeholders when the proposed regulatory amendments come into force.

These changes would significantly streamline the regulatory text of the research provisions found in the Pest Control Product Regulations, making them shorter and clearer and thereby addressing stakeholder concerns.

As they are aimed at simplifying and clarifying existing provisions, these proposed amendments are not anticipated to have any incremental impacts on stakeholders.

3.2.2 Defining restrictions on "residential areas" for additional clarity

Under section 53 and subsection 55(2) of the Pest Control Product Regulations, a research establishment would neither qualify for a research notification nor exempt research if their research is in "residential areas"; in other words, they must apply for a research authorization.

However, the term "residential areas" is not defined in the Pest Control Product Regulations, which could lead to some uncertainty regarding its meaning. The common dictionary definition refers to "places of residence" (in other words, homes). In contrast, the Pest Control Product Regulations states "residential areas, including lawns, gardens and parks" and DIR98-05 refers to "domestic/residential areas, including lawns/gardens". The use of "including" indicates a non-exhaustive list; "residential areas" is intended to apply to a broader sense than homes (for example, they could also include other areas beyond lawns, gardens and parks – such as public recreational areas/sports fields).

The proposal would provide greater clarity by defining these restrictions involving "residential areas" as any use site where it is reasonably expected that general public, including children, could be exposed during or after application This may involve broadening the terminology to "residential and other public areas".

This would not include those commercial, agricultural or industrial areas where the general public would not reasonably be expected to have access. The terminology would be broadened to reflect the definitions of residential areas that already appear on the labels of some registered pest control products (such as #4590, #5821, #6423, #8211). For example, in FYFANON 50% EC Emulsifiable Concentrate Insecticide #4590:

Residential areas are defined as any use site where bystanders including children could be exposed during or after application. This includes homes, schools, public buildings or any other areas where the general public including children could be exposed.

This would provide additional clarity and better reflect the intent of the existing provisions. As a result, this proposed amendment is not expected to have any incremental impacts on stakeholders.

3.2.3 Codifying existing policy for research involving human participants

Science Policy Note SPN2016-01, Restricted Use of Human Studies with Pesticides for Regulatory Purposes instructs researchers conducting tests on human participants to pass an ethics review and apply to the PMRA for a research authorization. Research of this type is rare, but possible. Currently, the Pest Control Product Regulations exempts certain research from the requirement to obtain a research authorization (in other words, those that meet the criteria for an exemption under section 51, subsections 55(1) and 55(2)) that could include human participants. The proposal would exclude research conducted with human participants from the exemptions under section 51 and both subsections 55(1) and 55(2) of the Pest Control Product Regulations. As such, any research involving human participants would require a research authorization. Requiring an applicant to apply for a research authorization for such research enables the PMRA to review the research proposal and ensure that measures are in place to mitigate the potential risks to health, safety and the environment.

As this amendment would codify existing policy, it is not expected to have any incremental impacts on stakeholders.

3.2.4 Clarifying research requirements in enclosed agricultural/horticultural structures

Research involving pest control products that is conducted in a greenhouse is not eligible for exemption under section 51 and subsections 55(1) and 55(2) of the Pest Control Product Regulations. As a result, all research involving pest control products conducted in greenhouses requires a research authorization or research notification (in the case of certain microbials). Research conducted in greenhouses are eligible for a lower research authorization fee rate in Schedule 3 item 1(d) of the Pest Control Products Fees and Charges Regulations.

The common definition of greenhouse does not include similar enclosed agricultural structures such as high tunnels, which are increasingly in use in Canada. While the PMRA issued Information Note Regarding Pesticide Use in High Tunnels in 2015 that defined "greenhouse" and "high tunnel", the fact that the regulations refer only to greenhouses has led to some ambiguity.

As a result, the PMRA is proposing to replace references to greenhouses in the Pest Control Product Regulations with more generic terminology, such as "enclosed agricultural/horticultural structures in which crops are grown", as criteria under which research would not qualify for either an research notification or an exemption under subsection 55(2).

Using more generic terminology to describe these types of structures, which include greenhouses and high tunnels, would allow flexibility to encompass other structures as the technology evolves. The inherent risks and conditions of exposure are similar in all of these types of enclosed structures and as such any research conducted in them should be treated the same. This will include a similar amendment to the term greenhouse in Schedule 3 Item (1)(d) of the Pest Control Products Fees and Charges Regulations. Additional clarity would be provided in updated policy/guidance documents.

Some stakeholders have requested that research conducted in "research greenhouses" be exempt from the requirement for a research authorization, similar to that for research conducted solely in a laboratory. The PMRA has decided not to add an exemption for research conducted in "research greenhouses". There is not sufficient evidence to indicate that all "research greenhouses" would be designed to provide a level of health, safety and environmental protection that would be considered equivalent to a laboratory. In addition, pest control products used in greenhouses and other enclosed agriculture structures have very different environmental and exposure risks compared to laboratories and as such cannot be considered the same way. For example, the method of application and the amount of pest control product used in research conducted in a greenhouse may be higher than that used in a laboratory, which results in an increased risk of exposure if the risks are not appropriately mitigated.

As this amendment would simply provide clarity and codify existing policy, it is not expected to have any incremental impacts on stakeholders.

Provisions regarding treated food or feed

Sections 68, 69 and 70 of the Pest Control Product Regulations specify requirements for the distribution of any treated food and feed crops from research sites and meat (including meat by-products and fat), milk and eggs that may contain residues as a result of research. Industry stakeholders have requested clarification with respect to these provisions, and specific reference to the common practice of crop destruct.

For example, section 68 of the Pest Control Product Regulations currently states:

"When a research authorization certificate is issued, treated food and feed crops from research sites and meat (including meat by-products and fat), milk and eggs that may contain residues as a result of the research must not be sold unless

The intent of sections 68–70 is that all treated food and feed would be destroyed, as they may not be safe for consumption, unless they meet the specific criteria. As such, the proposal would amend the research provisions to clearly indicate that all treated food, feed crops, meat, milk and eggs must be destroyed unless specific criteria are met.

The method of destruction would not be specified, but should be done in accordance with industry best practices (in other words, crop destruct), provincial law, or approved registered label conditions where applicable. Additionally, the PMRA is also proposing to rewrite and combine sections 68–70 into one section to add clarity and remove duplication.

As this amendment would simply clarify the intent of the existing provisions and reflect current practices, it is not expected to have any incremental impacts to stakeholders.

3.2.5 Updating references to the List of Formulants and Contaminants of Health or Environmental Concern

The List of Pest Control Formulants and Contaminants of Health or Environmental Concern (the List) was established under the Pest Control Products Act to increase transparency for pest control products, as substances on the list are not considered confidential business information and the public will be able to have access to it. For example, the identity of formulants on the List must be disclosed on pest control product labels as a condition of registration. Formulants and contaminants are identified for the inclusion on the List if they are designated for reduction and/or elimination under a binding international instrument that Canada has ratified or if they are part of a Canadian government policy/risk management strategy. In the Pest Control Product Regulations, any research involving a formulant or contaminant on the List is not eligible for a research notification (section 53) nor exempt research (section 55(2)).

However, formulants and contaminants can be removed from the List if they are no longer found in registered products. As the registration of pest control products that include chemicals for reduction or elimination come to an end, the List would not always be sufficient reference for the purposes of unregistered products intended for research.

Therefore, the PMRA is proposing that, in addition to the reference to the List, references to binding international instruments that Canada has ratified and committed to reduce or eliminate the use of a substance will be included. This would include the Montreal Protocol, Minimata Convention, and the Stockholm Convention.

Furthermore, the List is also referenced in 60(2)(b)(i)(F) to identify potential allergens on the experimental label. The PMRA is also proposing to amend this to incorporate by reference food allergens as defined in B.01.010.1 (1) of the Food and Drug Regulations for consistency.

As this amendment would continue existing policy, it is not expected to have any incremental impacts to stakeholders.

3.2.6 Clarifying area restrictions for subcontracted research establishments

Sections 53 and 55(2) of the research provisions include area restrictions for research conducted on land owned and operated by a research establishment. The purpose of these area restrictions is to set a maximum limit on the area used for research to control risks to human health and the environment. Research that exceeds such restrictions would require greater risk assessments (for example, a research notification that involves the use of a chemical pest control product on an area greater than 50 ha would require a research authorization).

In some circumstances, research establishments may wish to subcontract parts of the research to another research establishment. In such cases, the total area across all sites should considered as one research plan. As such, the proposal would amend the research provisions to clarify area restrictions for land owned and operated by research establishments to include land owned and operated by subcontracted researcher in addition.

As this amendment would continue existing policy, it is not expected to have any incremental impacts to stakeholders.

3.3 Proposed amendments to the research provisions that are anticipated to reduce regulatory burden

Internal program evaluation and comments from industry stakeholders (described below) have identified certain areas where proposed amendments to the Pest Control Product Regulations are likely to reduce regulatory burden, without negatively affecting health and environmental protection.

3.3.1 Establishing exemptions for research involving microbial agents

Currently, section 55 of the Pest Control Product Regulations does not exempt research involving microbial agents, unless the research is conducted solely in a laboratory. This rule was established, in part, so the PMRA could gather additional information and experience with respect to this type of research. However, the Pest Control Product Regulations does allow for research involving microbial agents under a research notification if certain criteria listed under section 53 are met.

Informed by the experience of reviewing research authorizations and notifications since the existing research provisions were codified in the Pest Control Product Regulations in 2006, the PMRA has determined that the risks associated with microbial agent research that meets the current criteria to qualify for a research notification, are well defined and considered low.

As a result, the PMRA is proposing to amend the Pest Control Product Regulations to provide an exemption for all research involving microbial agents that meet that current criteria for research notification (paragraphs 53(c)(i) to (iv)).

Research involving microbial agents that meets the current criteria would only be exempt if it does not involve human participants (see section 3.3.1) or it does not involve certain microbial agents that are a disease(s) or pathogen(s) of humans, animals or plants (see section 3.4.1).

Stakeholders would no longer have to complete an application to obtain a research notification before commencing this type of research or pay the associated fees. Consequently, there is expected to be a reduction in regulatory burden as a result of this proposed amendment.

3.3.2 Disposing of unused registered pest control product

Currently, section 66 of the Pest Control Product Regulations states:

"A research establishment must return to the manufacturer any unused registered pest control product unless it is kept by the research establishment to be used by a researcher or co-operator involved in the research in a way that is consistent with the directions on the approved label."

Industry stakeholders requested that the Pest Control Product Regulations be amended to allow unused products to be disposed of in accordance with any provincial legislation, which is consistent with the approved label of registered pest control products.

The proposal would amend section 66 to allow for use or disposal of an unused registered pest control product in a way that is consistent with the directions on the approved label.
There is expected to be a reduction in compliance burden as a result of this proposed amendment. Stakeholders will likely use the least burdensome and the most cost effective manner to dispose of unused registered product.

3.4 Proposed amendments to the research provisions that could increase regulatory burden

Internal program evaluation, and comments from industry stakeholders, has identified certain areas where amendments to the Pest Control Product Regulations could potentially increase regulatory burden, but are necessary for health and environmental protection. The exact level of the impact of these amendments is unclear at this time and the PMRA is looking for additional information from stakeholders to better qualify and quantify the expected incremental impact.

3.4.1 Removing exemptions for research involving microbial agents that are human, animal and plant diseases or pathogens

Currently, research involving microbial agents does not distinguish between different types of microbials. Microbial agent research is eligible for a research authorization, a research notification, or must be conducted solely in a laboratory. Certain microbial agent research involving human, animal, or plant diseases or pathogens have been identified as posing inherent risks and should always require a research authorization, specifically:

Requiring an applicant to apply for a research authorization for these types of research enables the PMRA to review the research proposal and ensure that measures are in place to mitigate the potential risks to health, safety and the environment. Additionally, researchers would continue to be subject to their obligations under the Human Pathogens and Toxins Act, the Health of Animals Act and the Plant Protection Act.

The proposal would exclude the above mentioned microbial agents that are human, animal or plant diseases or pathogens from the exemption under subsection 55(1); moreover the proposed exemption for microbial agents described in section 3.3.1 will not apply to these types of research. As such, any research involving pest control products that are diseases or pathogens would require a research authorization.

Previously, all research conducted using microbial agents required a research authorization or research notification and the PMRA has received infrequent applications in recent years for research involving a microbial disease or pathogen. Thus, there is expected to be minimal additional regulatory burden to stakeholders as a result of this proposed amendment.

4.0 Input requested

Health Canada is seeking input from interested Canadians on the proposed amendments to the Pest Control Products Regulations, as set out in this document. All interested Canadians are invited to submit their views.

In addition to general feedback on proposed regulatory amendments and associated changes to interpretive guidance, Health Canada is seeking feedback from regulated parties with respect to the regulatory impacts (costs and savings) that may be realized from the proposed amendments. A questionnaire can be found in Appendix I of PRO2022-01.

5.0 Next steps

Written comments on this proposal will be accepted up to 45 days from the date of publication. Please forward all comments to pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca. Please provide your comments and include the following information: your full name and, where applicable, your organization; and contact information that includes a telephone number as well as either a complete mailing address or email address.

Health Canada will consider all comments received, in anticipation of a formal consultation being issued in the Canada Gazette, Part I.

Please note that 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 Pest Control Products Act, consultation on those changes to policies and guidance will take place as required.

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