Pest Management Regulatory Agency newsletter

Fall 2023

In this issue:

• PMRA's Executive Director retired
• Next steps toward a sustainable approach to pesticides management in Canada
• Remotely piloted aircraft systems/drones
• Streamlined Category B Submissions guidance document
• IT modernization
• Data compensation program update
• Update to Registration of Non-Conventional Pest Control Products guidance
• Changes to the requirement for submission of executive summaries
• Registrants, keep your administrative contact information up to date
• Personal protective equipment for professional painters
• Alternate storage stability regime under DACO 3.5.10
• Planned publications for FY 2023-2024 from REV2023-01
• Planned re-evaluation initiations for FY 2023-2024 from REV2023-01
• Product discontinuations as outlined in REV2023-01
• Pesticide product changes: amendments and cancellations

Here is the latest news from Health Canada's Pest Management Regulatory Agency (PMRA). The newsletter is issued periodically and reports on the implementation of postmarket decisions, important Agency initiatives and projects, upcoming consultations and information to help registrants and stakeholders navigate PMRA business processes.

Initial round of re-evaluation completed

On 2 March 2023, the PMRA published the re-evaluation decisions for pyrethrins and piperonyl butoxide. These final decisions represented the completion of the initial round of re-evaluations of pesticides that were registered before 1995. A significant milestone for the Agency and the stakeholders.

Check out the latest work plan

On 26 June 2023, the latest work plan for postmarket reviews was published. The work plan (REV2023-01) lets you know when to expect new re-evaluations to be initiated and when consultation and decision documents of re-evaluations and special reviews are planned to be published.

PMRA's Executive Director retired

After more than 32 years with the Public Service working on and contributing to diverse and important files to Canada and Canadians, Executive Director Peter Brander retired in March.

Peter joined the PMRA in 2016 as Chief Registrar and Director General of the Registration Directorate. In 2019, he became the Executive Director of the PMRA and navigated us through a pandemic and numerous changes.

"Never doubt that a small group of thoughtful committed citizens can change the world; indeed, it's the only thing that ever has." - Margaret Mead

Stakeholders will no doubt remember Peter as approachable, forthright and solution-oriented. He was the same way with staff and he is dearly missed. When he became Executive Director, he shared this quote with staff:

We will keep this quote and Peter's passion for public service with us as we move forward.

In September, Frédéric Bissonnette assumed the role of Executive Director of the PMRA. Previously, Fred was Chief Registrar and Director General of the Registration Directorate. Work on Transformation – led by Manon Bombardier – continues and the team has been busy working with our partners and stakeholders toward implementation of these initiatives. We look forward to a future transformed Agency under the direction of Fred and Manon!

Next steps toward a sustainable approach to pesticides management in Canada

On 20 June 2023, the Honourable Jean-Yves Duclos, Minister of Health Canada (HC), along with the Honourable Steven Guilbeault, Minister of Environment and Climate Change Canada (ECCC), and the Honourable Marie-Claude Bibeau, Minister of Agriculture and Agri-Food Canada (AAFC), announced next steps toward a sustainable approach to pesticides management in Canada while also giving farmers the tools they need to keep providing reliable access to safe and nutritious food.

The announcement highlighted the following elements:

• The launch of Health Canada's Notice of Intent which began consultations on proposed amendments to the Pest Control Products Regulations.
• Health Canada's lifting of the pause on increases to pesticide Maximum Residue Limits (MRLs).
• The Government of Canada's elimination of the use of pesticides for cosmetic purposes on federal lands through amendments to the Greening Government Strategy, led by Treasury Board of Canada Secretariat.
• The Government of Canada's commitment to implementing the 2022 Kunming-Montreal Global Biodiversity Framework, which aims to halt and reverse biodiversity loss.
• An update on the PMRA's Transformation Agenda, which has and will continue to increase the transparency and accessibility of decisions.

Maximum residue limits (MRLs)

• Health Canada lifting the pause on increasing MRLs for pesticides will support predictability for agriculture and trade, provide tools to fight against new pests, and demonstrate the scientific integrity of the pesticide regulatory framework in Canada.
• With the lifting of the pause, the PMRA has published new web materials including an infographic and information video to help Canadians better understand what MRLs are, the science behind MRLs, how they are set, the MRLs outside of Canada, and the shared Federal responsibility for food safety in Canada.
• On 27 June 2023, Health Canada announced the release of the first proposed (PMRL) increase for consultation, starting with less complex proposals. This consultation, and future consultations for proposed increases to MRLs, includes an updated consultation notice with a plain language summary of the proposed decision and more clarity and information in the consultation report.

Other updates on PMRA's Transformation Agenda

Following the August 2021 announcement made by the Ministers of Health, Agriculture and Agri-Food and Environment and Climate Change, the PMRA launched a Transformation Agenda with a three-year mandate, ending in March 2024, to deliver on commitments that were made to strengthen the protection of human health and the environment, particularly in the regulation of pesticides.

Modernized business processes

Implementation of continuous oversight will increase the health and environmental protection of the Pesticide Regulatory Program through:

• Ongoing systematic collection and consideration of science information related to registered pesticides;
• Keeping pace with the evolving science and knowledge of pesticides in Canada and internationally;
• Implementation of timely regulatory action(s), as required, in response to new risks identified with registered pesticides; and
• Supporting the PMRA's science reviews and decision making with up-to-date science and regulatory information.

The PMRA is finalizing activities relating to continuous oversight to inform policy development. A draft of the Continuous Oversight Framework has been developed, and work is underway on the development of the Proportional Effort Framework, which recognizes that some pesticides require more regulatory oversight than others. The PMRA is establishing criteria that will guide the level of oversight and monitoring that is required for different pesticides, depending on their relative level of risk. These criteria will go through extensive internal testing and validation.

The Proportional Effort Framework will help the PMRA to allocate its resources based on the level of effort required. It will also make it more predictable for industry to prepare and submit a complete package of data and information for the PMRA's review, as needed.

Engagement with stakeholders on Continuous Oversight and Proportional Effort will take place in Fall 2023.

Improving transparency

Health Canada heard from stakeholders and Canadians that the key to improving transparency in the pesticide regulatory system is to improve understanding and better communicate the basis of the PMRA's decision-making.

Initiatives under the PMRA Transformation's pillar on transparency seek to increase public trust in the pesticide regulatory system and counter misinformation by:

• More effectively communicating how science is conducted at the PMRA;
• explaining how and why the PMRA considers information, conducts assessments and makes decisions; and
• improving the process to access data and information used in PMRA decision-making.

Health Canada has established a Science Communications Team, made up of trained science communicators to develop communication products that describe how science is conducted at the PMRA and how it informs decision-making. They work to communicate decisions clearly with the right information for the audience.

The first example of the PMRA's work to increase transparency in decision-making can be seen in the Atrazine consultation notice and summary. These documents were developed based on the scientific regulatory work undertaken by the PMRA. The summary was prepared from the more technical Proposed Special Review Decision document on Atrazine, to focus on the most relevant details from the technical document that are of greatest interest to a broader audience.

National Water Monitoring Program for Pesticides (NWMPP)

The PMRA is developing a framework to provide guidance for pesticide water monitoring programs. This framework will also guide the development and implementation of a long-term national-scale collaborative water monitoring program for pesticides. The development of this framework is being informed by extensive consultation with a Technical Working Group of experts from federal and provincial governments, academia, grower groups, industry, and non-governmental organizations. To help understand the feasibility of a long-term program, the PMRA developed a two-year pilot program in collaboration with ECCC and AAFC.

During the first year of this program (2022), 1294 samples were collected at 89 surface water sites in 8 provinces. For Year 2 (2023), sampling has commenced at more than 80 sites with a plan to sample approximately 100 surface water sites spread across all 10 provinces. Groundwater samples will also be analyzed in Year 2.

On 11 July 2023, data from the entire first year of the Water Monitoring Pilot Program for Pesticides was published to the Government of Canada Open Data Portal. The PMRA has developed a public-facing water monitoring for pesticides dashboard that allows for visualization and interpretation of the pesticide concentrations detected in the pilot program. This dashboard is accessible on the PMRA's water monitoring web pages.

National Pesticide Use Information Program (NPUIP)

The PMRA is developing a framework for a systematic approach to identify, access and manage pesticide use information. This framework will enhance the PMRA's ability to make robust and timely decisions on the health and environmental risks and value, as well as developing risk management options based on how pesticides are used in real-world scenarios. The development of this framework is being informed by extensive consultations with technical working groups. These consist of government partners and various stakeholders (for example, user groups, non-governmental organizations, registrants, academia).

In the first year of developing the program, priority was given to agricultural crop sectors with the most significant information gaps, beginning with horticultural crops. This was later broadened to other crops including grains, oilseeds and pulses.

Pilot opportunities in 2023-24 are currently being explored including targeted collaboration with greenhouse vegetable and apple sectors to address prioritized gaps; and custom surveys of select horticultural crops.

In December 2022, consultations began with non-crop sectors, with initial focus on the livestock, forestry/woodlot and structural/general outdoor sectors, and non-crop sector technical working group meetings have been completed.

A "What We Heard" Report will be published in Fall 2023. These consultations are being used to inform the development of the Pesticide Use Information Framework and policies that are planned to be completed by March 2024.

Remotely Piloted Aircraft Systems/Drones

The information note regarding the use of drones for applying pesticides has been updated. It communicates the requirements for Remotely Piloted Aircraft Systems (RPAS), drones or unmanned aerial vehicles to be specified on the pest control product label for this method of aerial application.

A few of the key points to be aware of:

• Products registered for application by drone will have "Remotely Piloted Aircraft Systems" and/or "RPAS" on the label. If these terms do not appear on pesticide labels, the use of drones to apply pesticides is not permitted under the Pest Control Products Act.
• The PMRA has not received any data to support the use of drones for pesticide application with active ingredients that require a drone-specific risk assessment.
• Until this information is received and appropriately assessed, drones will not be included on a pesticide label.
• Parties interested in using this new method of pesticide application should work with registrants who must submit label amendment applications to the PMRA, along with sufficient data to characterize the hazards/risks associated with this use.

Streamlined Category B Submissions guidance document

This guidance document (pursuant to the consultation document PRO2020-01),was published to help determine if your application is eligible for the streamlined Category B submission process. Category B submissions that require only value information are eligible for review as Category B streamlined submissions, provided that the request concerns:

• a decrease in the use rate;
• an increase in the level of control (for example, upgrading from suppression to control);
• the addition of a pest;
• the addition of a tank-mix; or
• the addition of the general label statement related to tank mixing found in the PMRA Guidance Document, Tank Mix Labelling.

In order to qualify as a streamlined Category B submission, the following conditions must be met:

• The total amount of product applied to the crop does not increase.
• Products proposed for use in tank-mixes must each be registered for the specific use site/crop, method of application, timing and rate.
• A maximum of six (6) label amendments are allowed within one submission. For example:
  • the addition of six (6) new pests;
  • a decrease in the application rate for three (3) pests already on the label and the addition of three (3) new pests; or
  • the addition of one (1) tank mix that is proposed to control five (5) pests that do not already appear on either tank mix partner label, etc.

IT modernization

The PMRA is in the process of modernizing its information technology (IT) systems with a first release completed in July which included a new web-based eIndex Builder Tool, as well as several updated HTML forms (6006, 6008, 6012, 6026, 6110, 6117, 6200). The PMRA also engaged stakeholders regarding pilot projects to develop a new pesticide use data intake form and a revised structured label form, specifically the primary panel and use index.

Additional releases planned for later this year and into 2024 will introduce a new portal to replace the current secure gateway, structured data from other label components, and online approved labels in a fully searchable and accessible format.

The vision is to transform the PMRA, moving from a legacy document-based process to a modern digital future, with an end-to-end data centric business model, where all pest product regulatory processes are managed within an interconnected system. This will enable registrants to file and manage their applications via an external facing portal, facilitate a more efficient data-driven scientific review process and allows the PMRA to more effectively release the data that supports our reviews, thus improving transparency.

For more information about the changes and release dates, please refer to the upcoming notices and highlights on the PMRA website for Registrants and Applicants or contact us at pmra.it.modernisation.ti.arla@hc-sc.gc.ca.

Clarification for the Proposed New Uses and/or Uses to be Withdrawn from the Label – Form 6023

The Pest Control Products Act requires the public registry to contain certain information about applications to register or amend the registration of a pest control product, including the proposed new uses for the product or any uses proposed to be withdrawn. To meet this requirement, applicants are required to submit Form 6023. It is a publicly available form which subsequently appears in the Pesticide Product Information Database > Published Documents, once the application is loaded into the PMRA database. The form must clearly identify any added or withdrawn site of uses and pests. Simply referring to the submitted label is not sufficient.

The following are some scenarios to provide applicants with guidance of how to improve the level of detail included in Form 6023. Note that these examples apply regardless of submission type (Notification, Category A, Category B, Category C, Master Copy) or whether data or a precedent product are used to support the submission in question.

Data compensation program update

The Regulations Amending the Pest Control Products Regulations (Exclusive Rights and Compensable Data): SOR/2023-104 were published in the Canada Gazette, Part II, Volume 157, Number 12 on June 7, 2023. These Regulations come into force 180 days after the day they are published in the Canada Gazette, Part II, on 4 December 2023.

Issues

While there are data compensation provisions in the Pest Control Products Regulations for re-evaluation and special review (postmarket review), stakeholders have indicated they are not comprehensive and clear. In addition, minor technical amendments are required to bring further clarity to the existing data compensation provisions.

Objective

The primary objective of the regulatory amendments is to clarify data compensation provisions for re-evaluations and special reviews by specifying a process under which registrants who are data holders and registrants who are relying on the data of data holders can establish compensation payable, what data is subject to compensation and when to initiate negotiations and binding arbitration (if necessary).

Next steps

To bring these amendments into force, the PMRA is working on finalizing the following documents for use by registrants and applicants:

• Agreement for Data Compensation at Re-evaluations and Special Reviews under Section 66 of the Pest Control Products Act, and
• Agreement for Data Compensation for Generic Product Applications under Section 66 of the Pest Control Products Act, and
• Guidelines for Reliance on Compensable Test Data Considered in Support of Re-evaluation and Special Review Decisions.

Guidance and upcoming consultation on the approach to implementing data compensation for previous re-evaluations and special reviews is also being worked on.

Update to the registration of non-conventional pest control products guidance

An update to the PMRA Guidance Document, Registration of Non-Conventional Pest Control Products was published in March, 2023 (PMRA Guidance Document, Registration of Non-Conventional Pest Control Products - Canada.ca). The major update to this document was the inclusion of Data Code (DACO) tables.

Changes to the requirement for submission of executive summaries

During re-evaluation, the PMRA requires registrants to submit lists of available studies (titles only) at the initiation phase, related to their active ingredient (DIR2016-04, Management of Pesticides Re-evaluation Policy). This information helps determine what data may need to be called-in for review.

In 2021, the PMRA introduced the requirement for executive summaries (i.e., study abstracts) to accompany each of the study titles in the data list when a higher priority re-evaluation was initiated.

Commencing with initiations for the 2023-24 fiscal year, the PMRA will no longer require executive summaries be submitted within 90 days of re-evaluation initiation and the following tiered approach will be followed for higher priority re-evaluations:

1. The PMRA will reinstate the courtesy head's up notification to registrants prior to initiation of re-evaluations.
2. Within 30 days of the re-evaluation initiation letter, registrants will be required to provide study lists for higher priority re-evaluations, prepared in accordance with the revised data list template (for example, full study titles, listed according to the PMRA's data codes (DACOs)). If the data lists submitted do not meet the requirements indicated in the study list template, registrants will be required to re-submit the data list in the required format within 15 days.
3. The PMRA will consider the data list as part of scoping and for establishing data requirements. However, if it is determined there are studies for which an executive summary is needed, registrants will be asked to provide requested executive summaries within 60 days.

As our efforts towards finding efficiencies and streamlining the data-call-in process continue, the PMRA may revisit this approach at a later date.

Questions

If you have any questions, please contact the Pest Management Regulatory Agency Information Service.

Registrants – keep your contact information up to date

Registrants are responsible for keeping your contact information up to date. Updated contact information is essential to ensure you do not miss any correspondence that could affect the registration of your pest control products.

Please email PMRA Reg Contacts/Titu ARLA (pmra.reg.contacts-titu.arla@hc-sc.gc.ca) with the following details for changes to the registrant contact:

• Registrant contact
• Title
• Telephone
• Email

For additional information and PMRA contact details for other administrative changes please see the following guidance: PMRA Guidance Document: Administrative Changes in Contact Information for Registered Pest Control Products.

Personal protective equipment for professional painters

Following the re-evaluation of a number of antimicrobial preservatives used to protect paints against spoilage, new personal protective equipment (PPE) requirements were identified for professional painters to reduce health risks associated with high preservative exposures during painting with an airless sprayer. The personal protective equipment will be included directly on the paint can label when required. Professional painters will need to wear the following PPE:

• cotton coveralls
• long-sleeved shirt
• long pants
• chemical-resistant gloves
• painter's hat
• and a respirator with National Institute for Occupational Safety and Health (NIOSH)-approved organic-vapour-removing cartridge with a prefilter approved for pesticides, or a NIOSH-approved canister approved for pesticides.

In order to help inform professional painters of the new PPE requirements, an infographic was developed for web posting and for distribution to various painter groups and associations.

Alternate storage stability regime under DACO 3.5.10

Health Canada's Guidance for developing datasets for conventional pest control product applications (updated February 2021) describes the chemistry data requirements to support applications to register end-use products and manufacturing concentrates, including storage stability data (DACO 3.5.10). For heat-sensitive products that are not suited to the preferred 54 °C/2-week storage regime, the PMRA is proposing to allow the use of a 40 °C/8-week accelerated storage stability regime as a new option for applicants to address the storage stability requirements.

Planned postmarket review publications for FY 2023-2024 from REV2023-01

PRVD

Proposed Re-evaluation Decision document

PSRD

Proposed Special Review Decision document

RVD

Re-evaluation Decision document

SRD

Special Review Decision document

June 2023

• Azoxystrobin PRVD
• Nucleopolyhedrovirus cluster RVD
• Picoxystrobin SRD
• Sodium chloride PRVD

July 2023

• Chondrostereum purpureum (Strain: PFC2139) RVD
• (Z)-9-Tricosene RVD

August 2023

• Agrobacterium radiobacter strain K84 and K1026 PRVD
• Hypochlorite cluster RVD

September 2023

• 1-Methylcyclopropene RVD

October 2023

• Bacillus sphaericus RVD

November 2023

• Fosetyl aluminum PSRD
• Octenol PRVD
• Silicon dioxide cluster RVD

December 2023

• 1 or 3-Monomethylol-5,5-dimethyhydantoin and 1,3 bis(hydroxymethyl)-5,5- dimethyhydantoin RVD
• Natamycin PRVD
• Nonylphenoxypolyethoxyethanol PRVD

January 2024

• Bacillus subtilis cluster RVD
• Dodecylguanidine hydrochloride RVD

February 2024

• Dicamba PSRD
• Potassium dimethyldithiocarbamate SRD
• Predacides cluster RVD
• Quizalofop-p-ethyl RVD
• Methyl bromide PSRD
• Methyl bromide PRVD
• S-metolachlor and R-enantiomer PRVD

March 2024

• Foramsulfuron PRVD

Planned re-evaluation initiations for FY 2023-2024 from REV2023-01

June 2023

• 3-Methyl-2-Cyclohexen-1-One^{Footnote *}
• Cellulose (from Powdered Corn Cobs)^{Footnote *}

July 2023

• Acequinocyl

August 2023

• Ammonium Bromide
• Prometryne Plus Related Active Triazines

September 2023

• Clomazone
• Didecyldimethylammonium (present as Carbonate and Bicarbonate Salts)

October 2023

• (S)-Methoprene
• Diuron

November 2023

• Streptomyces lydicus Strain WYEC108^{Footnote *}

December 2023

• Atrazine (plus related active Triazines)
• Fenbutatin Oxide

January 2024

• Chlorpropham
• German Cockroach Extract^{Footnote *}
• Metalaxyl cluster
• Pyroxsulam
• Rotenone

February 2024

• Bentazon cluster
• EPTC
• Ferric Sodium Ethylenediaminetetraacetic Acid^{Footnote *}
• Napropamide
• Oxamyl
• Sulfonyl Ureas cluster
• Triallate

March 2024

• Bispyribac-Sodium (KIH-2023)
• Sethoxydim

Product Discontinuations as outlined in REV2023-01

Coumaphos

• All end use products Discontinued. Re-evaluation closed.

Di-n-propyl isocinchomeronate

• All end use products Discontinued. Re-evaluation closed.

Diazinon

• Since the cumulative assessment was initiated, all diazinon products have been voluntarily discontinued by registrants and will expire in December 2023.

Fenbuconazole

• Registrants notified intent to voluntarily discontinue all end use products. Re-evaluation to be closed once the cancellation process is completed.

Hydramethylnon

• All end use products Discontinued. Re-evaluation closed.

Oxadiazon

• All end use products Discontinued. Re-evaluation closed.

Pantoea Agglomerans C9-1

• All end use products Discontinued. Re-evaluation closed.

Pentachlorophenol plus related active chlorophenols

• All end use products Discontinued. Special review closed.

Sodium dimethyldithiocarbamate

• All end use products Discontinued. Special review closed.

Pesticide product changes: Amendments and cancellations

Phosmet

Cancelled use with extended phase-out until 30 October 2024: Control of Japanese beetle on outdoor ornamentals grown for cut flowers

• Additional interim mitigation:
  • Limit to one application per season,
  • limited carrier spray volume, and
  • revised REIs

Linuron

Cancelled uses with extended phase-out until 5 November 2024: Chokecherries, dill, coriander, caraway, celery, and sweet white lupins

• Additional mitigation:
  • Limits on maximum annual application rates,
  • revised REIs and buffer zones

Mancozeb

Cancelled products – Last date of use is 19 November 2023

• All seed treatment products (including potato seed piece treatment)
• All end-use wettable powder or dust formulations

Chlorpyrifos

Cancelled products – Last date of use is 10 December 2023

• All chlorpyrifos products have been cancelled and the existing stocks of chlorpyrifos products in Canada are being phased out.

Thiophanate-methyl

Cancelled products – Last date of use is 3 December 2023

• Potato seed piece dust formulation

Tetrachlorvinphos

Cancelled products – Last date of use is 3 March 2024

• All Domestic class flea and tick powder and pet collar products

Pymetrozine

Cancelled products – Last date of use is 6 May 2024

• Outdoor uses including: Crop Group 4 (leafy vegetables), potatoes, highbush blueberries and tobacco, Rhodiola rosea, outdoor ornamentals and Christmas trees

Imidacloprid

Cancelled products – Last date of use is 19 May 2024

• All turf use products

(S)-kinoprene

Cancelled products – Last date of use is 16 June 2024

• All (S)-kinoprene products are to be phased-out

Cyromazine

Cancelled uses from product labels – Label changes in effect as of 16 December 2023

• Outdoor: Crop Group 4 (leafy vegetables except Brassica vegetables), Crop Group 5b (leafy brassica greens), celery, and outdoor ornamentals grown for cut flowers
• Greenhouse: ornamentals grown for cut flowers

Label amendments for accepted uses - Label changes in effect as of 16 December 2023

• Additional PPE, engineering controls, updated REIs and reduced number of applications per crop cycle
• Updated spray buffer zones, runoff and environmental precaution statements
• Additional precautions for consideration of bee reproduction effects

Cymoxanil

Label amendments for accepted uses - Label changes in effect as of December 16, 2023

• Increased PPE and limits to amount handled per day for potatoes
• Increased PPE during airblast application for caneberries
• Increased PPE during handheld (spot) applications
• Revised REIs and spray drift precautions
• Updated spray buffer zones, runoff and environmental precaution statements

Related information

• 2022 Fall PMRA Newsletter