Our Field Notes blog is intended to provide a high-level overview of the emerging issues in the landscape of pesticides in Canada, including happenings at the Pest Management Regulatory Agency (PMRA). In our first issue, we have focused on some of the PMRA's recent and current initiatives.
The PMRA has announced several pesticide-related initiatives expected to unfold in 2023, including with respect to vertical farming, a new approach to the sales reporting program and enhanced transparency for the public registry.
1. Vertical Farming
The PMRA has issued an Information Note advising growers and other stakeholders that there are no pesticides currently registered or authorized for use in Canada for use in vertical farming. Vertical farming crops are grown:
- indoors on vertically stacked or inclined layers and/or integrated in other vertical structures, and
- rely solely or largely on artificial lighting.
Greenhouse crops, in contrast, are generally grown in a single, horizontal layer and rely mostly on natural sunlight. Certain pesticides are registered with the PMRA for use in greenhouse growing, but these products have not been assessed for use in vertical farming, which may involve different risks to human health and the environment, and, therefore cannot be used in that environment.
A Health Canada Working Group, in cooperation with the provinces, has been established to determine if further data may be required for the registration of pesticides for use in vertical farming. Stakeholders can also communicate their interest to the PMRA in adding vertical farming production use to a registered product label under the User Requested Minor Use Label Expansion (URMULE) program.
2. Pesticide Sales Reporting Enforcement
Registrants are required to report sales information about their pesticides. The Pest Control Products Sales Information Reporting Regulations require registrants to submit an annual report to the PMRA indicating the quantity of their registered products sold to users in each province and territory during the previous calendar year, due June 1 of each year. This year, the PMRA is implementing a new approach and will not be following up with registrants who do not submit their reports by the deadline. Instead, Health Canada's Regulatory Operations and Enforcement Branch (Pesticide Compliance Program) will enforce the reporting requirements. Registrants who fail to submit their reports by June 1 will be subject to escalating enforcement actions and their non-compliance will be published online.
The PMRA is currently advancing its Transformation Agenda, which includes a number of initiatives intended to improve transparency and public access to information and data across the regulatory pesticide processes.
a) Public Registry
The PMRA is taking steps to align its transparency measures with those implemented by the United States Environmental Protection Agency (USEPA) and the Australian Pesticides and Veterinary Medicines Authority (APVMA) for applications pending a regulatory decision.
Several strategies are in the process of being implemented by the PMRA to make more information available to the public and enhance transparency of the pesticide regulatory process, including with respect to the application process. In October 2022, the PMRA released its Notice of Intent NOI2022-01, Enhanced Transparency of the Pesticide Regulatory Process, setting out its intention to disclose the names of applicants after administrative screening of certain types of applications. This will include business and individual names, which will be available in the Public Registry, consultation documents and decision documents.
b) Review of the PCPA
On March 21, 2022, Health Canada published aDiscussion Document, DIS2022-01,Further strengthening protection of health and the environment: Targeted review of the Pest Control Products Actin which it identified and posed seven questions to help inform whether targeted legislative changes to the Pest Control Products Act (PCPA) would be needed to achieve the transformation objectives, including four questions relating to improving transparency. On June 2, 2022, an additional eighth question was posted on the transformation web page for additional input. In response to a consensus request from stakeholders, and to give more time for feedback on the additional question, Health Canada extended the consultation period from May 20, 2022, to June 30, 2022.
In November 2022, Health Canada summarized the submissions it received during the consultation period in its publication What we heard.
4. Data Compensation in the Re-Evaluation Context-Guidance Forthcoming
Draft regulations clarifying data compensation in the context of the re-evaluation process were published in the Canada Gazette I on June 11, 2022, (Proposed Regulations). The PMRA also invited stakeholders to comment on the Proposed Agreement for Data Compensation at Re-evaluations and Special Reviews under Section 66 of the Pest Control Products Act (Proposed Section 66 Agreement). In this context, both the data holder and the registrant are already in the market and negotiate what one registrant will pay the data holder for access to data supporting the re-evaluation or special review of a pesticide.
The PMRA hosted a webinar on both the Proposed Regulations and the Proposed Section 66 Agreement on July 28, 2022. The long awaited guidance on how data compensation will work in the re-evaluation scenario will be published in the Canada Gazette II when finalized.
5. Proposal Regarding Adjuvants
The PMRA recently released a Guidance Document on Tank Mix Labelling. The document clarifies direction related to consistent tank mix labelling in response to comments received during consultation on Regulatory Proposal PRO2020-01,Streamlined Category B Submissions and Tank Mix Labelling in 2020.
A separate guidance document on Streamlined Category B submissions (previously referred to as Efficacy Reviews) will be published in the near future.
6. Amendments to the PCPA/PCPR regarding Research-Consultation Open to January 30, 2023
Pre-consultation is currently open on Regulatory Proposal PRO2022-01, Pre-Consultation - Proposed Regulatory Amendments to the Pest Control Products Regulations (Research) until January 30, 2023.
Exemptions in the PCPR enable the use of unregistered active ingredients and experimental uses of registered products for research purposes. The purpose of the research exemption 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. The proposed amendments aim to modernize the PCPR, including by broadening the range of permitted research to cover all research involving pest control products, as opposed to research for the purposes of an application for, or an amendment to, a registration.
Information regarding submitting comments is available on thePest Management Regulatory Agency Publications Sectionpage. Interested stakeholders are also invited to complete a questionnaire, which can be accessed by completing this publication request.
7. Treated Articles Finally Clarified
In case you missed it, recent amendments to the PCPRaddress many uncertainties that had surrounded the regulation of treated articles in Canada.
The Bennett Jones Agribusiness grouphas extensive knowledge and experience in the pesticide regulatory space and would be happy to discuss any questions you may have regarding these developments with you.
*The authors wish to thank Jeremy Cooney for his assistance in preparing this update.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.