Summary of public comments received on Regulatory Proposal PRO2024-03
Health Canada – Pest Management Regulatory Agency
3 July 2025
Comments received in response to Regulatory Proposal PRO2024-03, Consultation on the Proposed Approach for Registering Pesticide Uses on Cannabis and Industrial Hemp: Use-site Categories, Data Requirements and Label Statements, published on 8 August 2024, are summarized below along with the responses by the PMRA. These comments were taken into consideration to prepare the PMRA Guidance Document, Classification of Cannabis and Industrial Hemp Uses, Data Requirements and Label Amendments.
Comments related to Use-Site categories
Comment
There are too many use-site categories which could deter registrants from adding cannabis uses and cause long delays in registration. Use-site categories should be consolidated and data requirements harmonized.
PMRA response
There are several use-site categories that apply to cannabis and industrial hemp that represent the different uses of the crops, how they are produced, and the type of pesticide treatment proposed. No new use-site categories are being established through this guidance document. Use-site categories are used to describe where and how a pesticide is intended to be used. It categorizes the specific environments, areas, or applications in which the pesticide can be applied, which helps to assess the product's safety and efficacy for those particular scenarios. These categories guide the regulatory process and help ensure the product's risk assessments and approval align with intended use patterns, user safety, environmental impact, and effectiveness. When submitting a pesticide application to the PMRA, the specific use-site category or categories for the product must be indicated.
The use-site categories identified in the regulatory proposal were established previously and are not specific to cannabis or industrial hemp. Cannabis and industrial hemp are assessed as agricultural crops in the context of pesticide evaluation. The guidance related to use-site categories is intended to clarify the type of data required to evaluate human health and environmental risks and value for different uses of the treated crops, for example, treatment of seeds or propagation material vs. cannabis or industrial hemp products that can be eaten or inhaled. The data requirements affiliated with the different use-site categories apply to any agricultural crop. Only the requirement for pyrolysis data is unique to cannabis and industrial hemp. The data requirements specified for the use-site categories identified in this document are relevant for the production and end-uses of these crops.
Some data requirements overlap between use-site categories. In these cases, the request is consolidated and the overlapping data only needs to be submitted once.
Comment
Is postharvest application classified under use-site category 12 or is it not permissible?
PMRA response
Postharvest treatment of agricultural crops, including cannabis and industrial hemp, falls under use-site category 12. However, as indicated in Section 4.0 of this guidance document, data requirements for stored cannabis and industrial hemp commodities and storage areas are not within the scope of the guidance. Applicants proposing pesticide applications to cannabis or industrial hemp postharvest must submit the appropriate data to assess any risks of this use to human health and the environment as well as to determine the value of the proposed use in order to add a claim to their label. Presubmission consultation is available to applicants who need guidance on required data.
Comment
The end use of a cannabis crop (for example, edible vs smoked/vaped products) is often not known at the time of production and registrants may not provide the data requirements to cover all possible cannabis uses. Dietary and pyrolysis data should be conditional requirements under use-site categories 5 and 14.
PMRA response
Food crop designation is a best-fit scenario for cannabis and industrial hemp intended for cannabinoid extraction due to the fact that the crops can be added to edible products. The need for the assessment of inhalation risk is an additional consideration for these crops as they can be smoked or vaped as a form of consumption. use-site categories 5 (Greenhouse Food Crops) and 14 (Terrestrial Food Crops) should be selected by registrants for pesticide uses that are intended to treat edible crops. These use-site categories apply to any edible agricultural crop, not just cannabis and industrial hemp. Dietary risk assessments are necessary for any agricultural crop treated with a pesticide that will be ingested, including cannabis and industrial hemp flowers. In addition, pyrolysis studies are required specifically for cannabis and industrial hemp that will be smoked or vaped. As for any data requirement, pyrolysis studies may be addressed with an acceptable data waiver rationale.
Registrants or applicants may not know where cannabis and industrial hemp crops treated with the specific pesticide will end up at the outset; however, cannabis products can be sold for edible or smoke/vape markets only if a prior approval is obtained from Health Canada for use-site category 5 or 14 applications supported by necessary data for dietary and/or inhalation risk assessments. Applicants can also request a presubmission consultation to confirm what data is required.
Comments related to Data Requirements
Comment
The requirement for pyrolysis data could remove access to the use of currently registered biopesticides after the flowering stage. Registrants may opt to let industrial hemp registrations lapse rather than making mandatory updates to labels.
PMRA response
Not all of the biopesticides currently registered for use on cannabis and industrial hemp require the submission of pyrolysis data. Biopesticides proposed to be applied at the flowering stage to cannabis or industrial hemp destined for the smoking or vaping market must be supported by pyrolysis data, unless the requirement can be satisfied with a data waiver. For industrial hemp, if the crop is grown for fiber or non-combustion uses, pyrolysis data is not required.
Comment
The testing requirements between indoor and outdoor pesticide uses to quantify the environmental impacts of pesticide usage should be distinguished.
PMRA response
There are different environmental data requirements for indoor cannabis production (for example, use-site category 5: Greenhouse Food Crops) and outdoor cannabis production (for example, use-site category 14: Terrestrial Food Crops). To quantify the environmental impacts of pesticide usage, the PMRA's environmental data requirements were developed based on use site categories (see PMRA Regulatory Proposal PRO2016-01: Revised Environmental Data Requirements). Each use-site category has an identified exposure scenario that determines the type of fate and effects data required to conduct an environmental risk assessment for that type of exposure scenario.
Comment
Only inhalation and dietary exposures are mentioned in guidance. If topically-applied products or products applied in other ways are not under the jurisdiction of the Pest Control Products Act, it should be clearly stated.
PMRA response
In addition to inhalation and dietary exposures, the PMRA also evaluates occupational and residential exposure risks for all (agricultural) pesticides. Residues of pesticides in cannabinoid extracts from cannabis that would be used in topically applied products would be considered chemical contaminants and are regulated under the Cannabis Regulations (SOR/2019-06, s.28). As such, these products are outside the scope of the regulatory proposal. This information has been added to the guidance (Section 3.0).
Comment
There should be distinction between products that are inhaled or ingested in terms of required residue studies. Is there a difference between residue requirements for edible products and smoke/vape products?
PMRA response
A supervised residue trial study (DACO 7.4.1) is conducted to determine the level of pesticide residues that remain in or on crops after application. The DACO 7.4.1 requirement for a pesticide use on cannabis would be the same as for any other agricultural crop. The parts of the plant that are harvested and analyzed in a residue trial study are the parts that are typically consumed. In a supervised residue trial study for cannabis, the flower (bud) is the primary part of the plant that should be analyzed, because it is the part most commonly consumed, whether for smoking, vaping, or for edible products. Therefore, the DACO 7.4.1 requirement for pest control products that are proposed for use on cannabis that may eventually be smoked, vaped, or ingested are the same.
Comment
If cannabis is not considered a food, why are residue studies required? The terms "edible cannabis/seeds" should be added to the definition of use-site category 5 in future documentation.
PMRA response
The supervised residue trial study (DACO 7.4.1) is required for cannabis because it can be used in foods consumed by humans (for example, edible products, such as cannabis butter and oil made from ground cannabis flowers). Additionally, a supervised residue trial study for cannabis would be used in conjunction with a pyrolysis study (DACO 7.8.1) to understand how pesticide residues behave when cannabis products are combusted (smoked) or vaporized. While the residue trial identifies the levels of pesticide residues present on the cannabis plant (flowers) after application, the pyrolysis study assesses how these residues change or break down when exposed to high heat, as occurs during smoking or vaping. Combining these studies is essential to ensure consumer safety, especially for inhalable products, where pesticide residues can create toxic byproducts.
The description of use-site category 5 (and 14) in the regulatory proposal indicated "Cannabis and industrial hemp crops grown indoors and intended for human consumption (for example, edible seeds, edible oils, cannabinoid production and products vaped or smoked)". This information will be carried over to the guidance document.
Comment
One commenter expressed concerns about animal testing related to pyrolysis studies and offered suggestions for consideration.
PMRA response
Pyrolysis studies are conducted directly on the treated cannabis or industrial hemp flowers and do not involve animal testing.
Comment
Guidance on generation of inhalation data should be provided. Other approaches to assess inhalation risk should be investigated.
PMRA response
A pyrolysis study should be conducted with the radiolabelled pesticide for the purpose of identifying and characterizing the pyrolytic by-products that may form as a result of the combustion and vaporization of a pesticide. The protocol for conducting pesticide pyrolysis studies on cannabis and industrial hemp would closely follow established methods used for tobacco pyrolysis studies. Pyrolysis studies on cannabis and industrial hemp should be conducted at temperatures at which the cannabis or industrial hemp product is smoked and vaped.
While the PMRA remains open to considering new and valid sources of data, it is unaware of other scientifically validated approaches to accurately determine by-products from combustion or vaporization and assess risks from inhalation. Alternatively, an acceptable scientific rationale continues to be an option for addressing this data requirement.
If application of biopesticides to cannabis and industrial hemp crops is limited to the pre-flower stage, pyrolysis or combustion data (DACO 7.8.1) are not required. Applicants are also encouraged to request a pre-submission consultation to confirm data requirements and acceptability of study protocols.
Comment
The requirement for four pyrolysis studies (required for the following uses: indoor grown cannabis that is vaped; indoor grown cannabis that is smoked; outdoor grown cannabis that is vaped; outdoor grown cannabis that is smoked) should be reduced to one for all potential uses (for example, indoor/outdoor cannabis that is vaped/smoked).
PMRA response
Only two pyrolysis studies are required; one at the temperature at which the product will be smoked and one at the temperature at which the product will be vaped. This data will inform both indoor and outdoor production. An acceptable scientific rationale to waive this data requirement may also be provided.
Comment
Additional guidance on waiver rationales should be provided to applicants.
PMRA response
In lieu of submitting the required data/information, the registrant/applicant may submit scientific rationales to waive the requirements. A written rationale to waive a specific data requirement or study should explain in detail why the study is not needed to support the proposed uses for specific pesticide products. The rationale must be based on scientific principles and should be supported by published scientific literature. Upon receiving the rationales, the suitability of any waiver will be assessed during a full evaluation.
A pre-submission consultation request may be made to the PMRA by the registrant/applicant in order to obtain further guidance on the information required to support the registration of a cannabis and/or industrial hemp use specific to their product, including advice on the considerations for preparing scientific rationales or comments on the potential acceptability of a data waiver.
Comment
Registrants may not support generation of additional data requirements due to lack of understanding of primary industrial hemp end uses and may not have the financial incentive to generate costly studies to meet data requirements outlined in the regulatory proposal.
PMRA response
Pesticide uses may be registered on industrial hemp under use-site category 7 (Terrestrial Non-food and Non-feed Seed and Fiber Crops) through the User-Requested Minor Use Label Expansion (URMULE) program with the support of Provincial Minor Use Coordinators and/or the Pest Management Center of Agriculture and Agri-Food Canada.
Cannabis and industrial hemp growers are also encouraged to continue their engagement with pesticide registrants to emphasize the importance of pesticide registrations on their crops and explore ways to facilitate the production of data required to ensure their products can be applied to cannabis/industrial hemp without unacceptable risks to human health and the environment.
Comment
Is it possible to submit pyrolysis data generated on tobacco to support the risk assessment for cannabis uses?
PMRA response
Pyrolysis data is pesticide specific. It is unlikely that tobacco data on hand would be sufficient to assess the biopesticide products used on cannabis. Pyrolysis data is also temperature dependent. Data generated for tobacco would not be suitable to assess smoking and vaping temperatures for cannabis since pyrolysis studies produced for tobacco are conducted at a different temperature. An acceptable scientific rationale to waive this data requirement may be provided.
If application of biopesticides to cannabis and industrial hemp crops is limited to the pre-flower stage, pyrolysis or combustion data (DACO 7.8.1) are not required.
Comment
Is pyrolysis data required for pesticides applied prior to flowering or for products applied to roots, mother plants, or clones?
PMRA response
If application of pesticides to cannabis and industrial hemp crops is limited to the pre-flower stage, pyrolysis or combustion data (DACO 7.8.1) are not required. Root dip or soil drench applications of a pesticide would not be made to the flowering portions and therefore pyrolysis data would not be required. Mother plants, by definition, are kept in the vegetative stage and prevented from flowering. Likewise clones which are typically very small (2 to 3 internodes) are also kept from flowering to encourage vegetative growth. Any application type for biopesticides that avoids treatment of flowers would not require pyrolysis data.
Pyrolysis data are required for the use of conventional pesticides applied at any growth stage and to any parts of the cannabis or industrial hemp plant, unless it can be demonstrated that no quantifiable residues are expected in the flowers grown from the treated plants.
Registrants/applicants are strongly encouraged to request a pre-submission consultation in order to obtain further guidance on the information required to support the addition of the use on cannabis and/or industrial hemp use to their product label. An acceptable scientific rationale to waive this data requirement may also be provided.
Comment
Will MRLs be established for cannabis uses?
PMRA response
Given that cannabis and seeds and extracts from industrial hemp can be used in foods consumed by humans, Maximum Residue Limits (MRLs) can be established for conventional pesticides when an application for its use on cannabis is approved in Canada. No such products are currently registered for use on cannabis.
Comments related to Labelling Requirements
Comment
There should be a clear timeline for label updates to avoid confusion or overlap in labelling requirements. The 9-month timeline to complete required label updates may be too short due to time required to generate pyrolysis data or waiver rationales. This short timeline may lead to a lack of registered pesticides that could be applied during the flowering stage.
PMRA response
The label statements indicated in the regulatory proposal are required only if certain data (for example, inhalation data) has not been submitted or if evaluation of submitted data identifies unacceptable risks to human health and/or the environment. It is not necessary to generate and submit pyrolysis data or data waiver rationales before amending the label. The label statements are required in the interim until the additional inhalation data has been assessed.
Inhalation risks have been evaluated based on the information available for currently registered pesticides. Additional data is required to ensure existing mitigation measures are appropriate. Label statements are required in the interim until the inhalation risk assessments are confirmed with new data. Once the new data has been assessed, the label statements can be removed.
To alleviate concerns that the timeline does not provide adequate time for registrants to address the required label amendments, the PMRA agrees to extend the timeline to 2 years.
Comment
Will the PMRA allow industrial hemp uses to be separated on labels (food vs smoked for CBD vs fiber vs industrial)? The commenter requested amendments to the approach to distinguish industrial hemp from cannabis for pesticide registrations, including minor use (MU) registrations.
PMRA response
The terms "cannabis" and "industrial hemp" will be used for pest control product labels, as they align with the terminology used in the Cannabis Act and Industrial Hemp Regulations. The PMRA considers cannabis and industrial hemp as two distinct crops based on their tetrahydrocannabinol (THC) content. Users should apply products that specifically identify their crop on the label. Pesticide uses registered for industrial hemp are not permitted on cannabis, and vice-versa.
Pesticide uses for any agricultural crop added to pesticide labels, including those added under the User-Requested Minor Use Expansion (URMULE) program, are assigned to a use-site category which determines data requirements and the risk assessments required to ensure that the pesticide does not pose unacceptable risks to human health and the environment when used according to the label directions. Pesticide risk assessments for fiber and CBD hemp are differentiated by the selected use-site category and data requirements. Here are some examples:
- Industrial hemp grown for fiber production would be assigned to use-site category 7 (Terrestrial Non-food and Non-feed Seed, Fiber, and Industrial Crops). Pesticide evaluations conducted under use-site category 7 do not require the assessment of dietary or inhalation risk.
- Industrial hemp grown for the production of hemp seed would be assigned to use-site category 14 (Terrestrial Food Crops) and would be subject to a dietary risk assessment. Pyrolysis data are not required for the assessment of dietary risk.
- Industrial hemp grown for the production of cannabinoids would be assigned to use-site category 14 (Terrestrial Food Crops) and would be subject to an inhalation risk assessment. This can be addressed with pyrolysis data or a suitable data waiver.
Statements prohibiting certain uses of these crops will be included on pesticide labels if the risks related to those uses have not been assessed or have resulted in unacceptable risk.
Comment
Label updates required as a result of this new policy should be allowed to be made through open applications to provide registrants time to generate new data or waivers and allow for a controlled phase-in and prevent loss of pest management tools available to users.
PMRA response
As stated in the regulatory proposal, the PMRA will continue to apply label updates through open submissions, re-evaluations, and special reviews. Pesticides currently registered for use on cannabis and industrial hemp will not be cancelled by the PMRA in the interim prior to the submission of inhalation data. Once updated, the labels will indicate if the treated cannabis and/or industrial hemp crop should not be used to produce edible products and/or smoke/vape products based on which risks have been assessed and the outcome of the evaluation.
Comment
To further enhance clarity on pesticide labels, the rationale behind label prohibitions should be included on the pesticide label.
PMRA response
A pesticide label is a legal document that serves the important role of informing users of a product's proper use and its potential hazards. Too much information on a label can be counterproductive and detract from the intended purpose. As such, label information must be clearly written and presented to help users comply with the instructions and minimize the risks associated with the product's use. Risk mitigation statements required on labels are based on specific requirements arising from registration decisions that can be found in regulatory documents available in the PMRA's Public Registry. They may also be required based on Directives and Guidance Documents that can be accessed through the Pesticides section of Canada.ca.
Comments related to pesticide evaluation for cannabis in the US
Comment
The PMRA's requirement for pyrolysis data to register pesticides for certain uses on cannabis and industrial hemp is not consistent with the approach of other pesticide regulatory authorities in the United States such as the California Department of Pesticide Regulation (CalDPR) and the Colorado Department of Agriculture (CDA).
PMRA response
The PMRA follows a rigorous scientific assessment process to ensure that pesticides do not pose unacceptable risks to human health and the environment while being effective for their intended use. Previously when assessing use of pesticides on medical cannabis, the PMRA only considered the oral route of exposure. With the legalization of recreational cannabis, and recognition that smoking/vaping are the primary routes of exposure, the evaluation approach had to evolve to consider exposure to pesticides on treated cannabis via smoking or vaping. This evaluation is supported by pyrolysis data or a suitable data waiver. Whenever possible, the PMRA considers approaches by other pesticide regulatory authorities. Ultimately, however, the PMRA's approach is based on the requirements set out under the Pest Control Products Act, the pesticide registration process, and applicable policies.
Comments related to Legislation as it applies to the production of cannabis and quality assurance procedures by Licence Holders
Comment
Section 138 of the Cannabis Regulations should be amended to include a requirement to clearly state the allowable intended uses directly on the bulk package to ensure that pesticide risk assessments align with end-uses once they are determined. Consideration of label requirements for bulk cannabis (not converted to cannabis product) is recommended to ensure that pesticide risk assessments align with the end-use once determined. This would be particularly beneficial when bulk cannabis is sold to another Licence Holder (LH) but complete batch records are not provided to the receiver per quality agreements.
PMRA response
Sub section 81(1) of the Cannabis Regulations states that "Cannabis must not be treated with a pest control product unless the product is registered for use on cannabis under the Pest Control Products Act or is otherwise authorized for use under that Act."
Potential pest control products and cannabis use scenarios are considered in the risk assessments as part of the registration process. Only those pest control products that are deemed to not pose a risk of concern when used accordingly with the label directions are registered.
The intended use of the cannabis remains a licence holder business decision. It is the licence holder's responsibility to demonstrate compliance with the applicable regulatory requirements. Licence holders must ensure that a lot or batch of cannabis meets the requirements outlined in section 5.0 of the Mandatory cannabis testing for pesticide active ingredients (MCTPAI) before releasing a lot for sale, including bulk cannabis, or prior to processing it. This means, in accordance with section 5.2 of the MCTPAI, ensuring that the cannabis has been tested, or testing it after it is received from a holder of a licence for cultivation, processing, or industrial hemp, or, in the case of a holder of a licence for both processing and cultivation, after it is harvested and/or dried.
The burden is on the holder of a licence for processing to ensure that the dried cannabis has been tested and meets the MCTPAI before conducting any other activity with it. Therefore, the holder of a processing licence must request the test results of the lot upon purchase should they have not been shared with the purchased lot or batch.
From 8 June 2024 to 8 July 2024, stakeholders and the public had an opportunity to provide their comments in regards to the Cannabis Regulations amendments during the "Consultation on proposed amendments to regulations concerning cannabis: Streamlining of requirements".
Comments related to the regulatory proposal
Several editorial changes were suggested and the guidance document has been revised.
Comments related to Licencing for analytical testing of cannabis
Comment
Conventional product registrants have indicated reluctance to add cannabis uses to the labels of registered pesticides due to the requirement for pyrolysis data as this study is cost-prohibitive. Plus, analytical testing at the capacity required by the cannabis industry does not exist in Canada (requires Health Canada licensed Research and Development facilities to grow cannabis for pesticide manufacturers). Laboratories and research facilities have indicated they do not intend to conduct pyrolysis testing due to a lack of funding, which could affect registrant willingness to add pesticide uses on cannabis to their labels. The commentor recommends interaction with Health Canada branches to identify expedited licensing support for labs and facilities to conduct pyrolysis studies, and to also work with Health Canada-relevant departments to develop or identify funding pathways to meet data needs.
PMRA response
There are several laboratories within Canada that are certified to conduct pyrolysis testing on treated cannabis and industrial hemp.
Research and development facilities can obtain a licence to conduct analytical testing on cannabis through the Controlled Substances and Cannabis Branch (CSCB) of Health Canada. Once the facilities and personnel responsible for the testing are in place, a licence application may be made. The service standard for obtaining an analytical licence is 180 business days. A list of laboratories licenced to conduct activities on cannabis in Canada under the Cannabis Act can be found on the Health Canada website. For general questions about cannabis research or analytical testing licences, contact CSCB by email at cannabis@hc-sc.gc.ca or by phone at 1-866-337-7705 (toll free).
Health Canada does not provide funding to support any agricultural sector in pursuing pesticide registrations.
Comments related to stakeholder education
Comment
A stakeholder education component is important, particularly one that is directed towards applicators and cannabis product manufacturers. Guidance documents or educational resources such as webinars hosted by the PMRA or CSCB will help stakeholders understand the new requirements and how they apply to different scenarios. Both registrants and Licence Holders should be included.
PMRA response
This guidance document from the PMRA informs applicants as to how risks associated with pesticide use are evaluated and the scientific data required to assess the risks. This guidance document provides this information as it pertains to the registration of pesticide uses on cannabis and industrial hemp. Additional guidance materials related to pesticide registration are available on the Pesticides section of Canada.ca. The PMRA will also present webinars to clarify the information. Quality assurance processes may require consideration to ensure that crops are properly directed in the marketplace.