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.
PMRA 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.
3. Transparency
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 a Discussion
Document, DIS2022-01, Further strengthening protection of health and
the environment: Targeted review of the Pest Control Products Act in
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 the Pest Management Regulatory Agency Publications Section page. 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 PCPR address many uncertainties that had surrounded the regulation
of treated articles in Canada.
The Bennett Jones Agribusiness group has 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.
Bennett Jones