Re-evaluation Decision RVD2021-08, Cyromazine and Its Associated End-use Products

Pest Management Regulatory Agency
16 December 2021
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2021-8-PDF (PDF version)

Summary

Table of contents

• Re-evaluation decision for cyromazine and associated end use products
• Re-evaluation decision for cyromazine
• Risk mitigation measures
• Next steps
• Other information
• Appendix I - Registered products containing cyromazine in Canada

Re-evaluation decision for cyromazine and associated end use products

Under the authority of the Pest Control Products Act, all registered pesticides must be re-evaluated by Health Canada’s Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies, as well as comments received during public consultations. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Cyromazine is a systemic insecticide and insect growth regulator that is registered for commercial use for the control of a variety of pests on potatoes, greenhouse ornamentals, outdoor ornamentals, mushrooms, greenhouse vegetables, and field vegetables. Cyromazine is also registered for the importation of treated dry bulb and green onion seeds. Currently registered products containing cyromazine can be found in the Pesticide Label Search and in Appendix I. The Proposed Re-evaluation Decision PRVD2020-02, Cyromazine and Its Associated End-use Products,^{Footnote 1} containing the evaluation of cyromazine and proposed decision, underwent a 90-day consultation period ending on 5 May 2020. PRVD2020-02 proposed cancellation of all uses except planting of treated green onion seeds, and use on outdoor ornamentals not grown for cut flowers, and mushrooms; additional risk mitigation measures were proposed for these uses.

Health Canada received comments and information relating to the health and value assessments. Commenters are listed in Appendix II of RVD2021-08. These comments are summarized in Appendix III along with the responses by Health Canada. These comments and new data/information resulted in revisions to the occupational risk assessment (see Science evaluation update, and Appendix IV of RVD2021-08), and resulted in changes to the proposed re-evaluation decision as described in PRVD2020-02.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2020-02, and further information used in the re-evaluation decision is listed in Appendix VI of RVD2021-08. Therefore, the complete reference list of all information used in this final re-evaluation decision includes both the information set out in PRVD2020-02 and the information set out in Appendix VI of RVD2021-08.

This document (Re-evaluation Decision RVD2021-08, Cyromazine and Its Associated End-use Products) presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of cyromazine, including the required amendments (risk mitigation measures) to protect human health and the environment, as well as label amendments required to bring labels to current standards. All products containing cyromazine that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for cyromazine

Health Canada has completed the re-evaluation of cyromazine. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing cyromazine is acceptable. An evaluation of available scientific information found that some uses of cyromazine products meet current standards for protection of human health and the environment and have acceptable value when used according to revised conditions of registration, which includes new mitigation measures.

The following uses of cyromazine are cancelled, since health risks were not shown to be acceptable when used according to the current conditions of registration or when additional mitigation is considered:

• 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, as summarized below and listed in Appendix V of RVD2021-08, are required for the continued registration of the remaining uses.

Risk mitigation measures

Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law. The required amendments, including any revised/updated label statements and/or mitigation measures as a result of the re-evaluation of cyromazine, are summarized below. Refer to Appendix V of RVD2021-08 for details.

Human health

To protect workers and those entering treated areas from potential occupational exposure, the following risk-reduction measures are required for the continued registration of cyromazine in Canada:

• Cancelled uses to be removed from product labels:
  • 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.
• For the following remaining uses, additional personal protective equipment (PPE), engineering controls, updated restricted-entry intervals (REIs), and/or reduction of the number of applications per crop cycle:
  • Outdoor: potatoes, outdoor ornamentals not grown for cut flowers;
  • Commercial planting: dry bulb onion seeds and green onion seeds;
  • Greenhouse: ornamentals not grown for cut flowers and lettuce;
  • Mushroom houses: mushrooms.

Environment

To protect the environment, the following measures are required:

• Standard environmental hazard statements to inform users of the potential toxic effects on birds and mammals (from cyromazine-treated seeds), beneficial insects, non-target terrestrial plants and aquatic organisms.
• As a precaution, the potential effects to bee reproduction and brood development will be indicated on the label. Best practices are recommended.
• To mitigate the potential exposure of cyromazine to non-target organisms, spray buffer zones are required to protect sensitive terrestrial and aquatic habitats from spray drift (3 metres).
• A statement is required on product labels to inform users that residues of cyromazine (melamine) have the potential to carry over to the next season and leach to groundwater.
• To reduce the potential for runoff of cyromazine to adjacent aquatic habitats, precautionary label statements for sites with characteristics that may be conducive to runoff and when heavy rain is forecasted are required.

Next steps

To comply with this decision, the required amendments (mitigation measures and label updates) must be implemented on all product labels no later than 24 months after the publication date of RVD2021-08. Accordingly, both registrants and retailers will have up to 24 months from the date of this decision document to transition to selling the product with the newly amended labels. Similarly, users will also have the same 24-month period from the date of RVD2021-08 to transition to using the newly amended labels, which will be available on the Public Registry.
Refer to Appendix I for details on specific products impacted by this decision.

Other information

Any person may file a notice of objection^{Footnote 3} regarding this decision on cyromazine and its associated end-use products within 60 days from the date of publication of RVD2021-08. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of the Canada.ca website (Request a Reconsideration of Decision) or contact the PMRA’s Pest Management Information Service by phone (1-800-267-6315) or by e-mail (pmra-info-arla@hc-sc.gc.ca).

The relevant confidential test data on which the decision is based (as referenced in PRVD2020‑02 and in Appendix VI of RVD2021-08) are available for public inspection, upon application, in the PMRA’s Reading Room. For more information, please contact the PMRA’s Pest Management Information Service.

Appendix I Registered products containing cyromazine in Canada