Re-evaluation Decision RVD2022-12, Trinexapac-ethyl and Its Associated End-use Products

Pest Management Regulatory Agency
18 August 2022
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2022-12E-PDF (PDF version)

Summary

Table of contents

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

Re-evaluation decision for trinexapac-ethyl 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.

Trinexapac-ethyl is a plant growth regulator that inhibits the biosynthesis of gibberellin, a phytohormone that promotes growth of various plant organs. Trinexapac-ethyl is used on turf grown on commercial sod farms and golf courses to reduce the frequency of mowing and the amount of grass clippings. It also manages the growth of perennial ryegrass grown for seeds to reduce lodging and thus, improve seed yield and quality. Currently registered products containing trinexapac-ethyl can be found in the Pesticide Product Information Database and in Appendix I.

This document (Re-evaluation decision RVD2022-12, Trinexapac-ethyl and Its Associated End-use Products) presents the final re-evaluation decision^Footnote 1 for the re-evaluation of trinexapac-ethyl, including the required risk mitigation measures to protect human health and the environment, as well as label amendments required to bring labels to current standards. All pest control products containing trinexapac-ethyl that are registered in Canada are subject to this re-evaluation decision.

Prior to finalizing this decision, Health Canada published the Proposed Re-evaluation Decision, PRVD2022-01, Trinexapac-ethyl and Its Associated End-use Products,^Footnote 2 for a 90-day consultation period, which ended on 25 April 2022. PRVD2022-01 proposed that products containing trinexapac-ethyl are acceptable for continued registration in Canada, provided that the additional proposed risk mitigation measures are in place. The proposed risk mitigation measures included updating restricted-entry interval (REI), adding the standard drift mitigation label statement, updating the personal protective equipment (PPE) label statements to reflect current standards, environmental precautionary label statements, and spray buffer zones.

No comments were received during the consultation period. Therefore, this decision is consistent with the proposed re-evaluation decision stated in PRVD2022-01, which lists all information used as the basis for the re-evaluation decision.

A reference list of data used as the basis for the re-evaluation decision is included in PRVD2022-01.

Re-evaluation decision for trinexapac-ethyl

Health Canada has completed the re-evaluation of trinexapac-ethyl. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing trinexapac-ethyl is acceptable with label amendments. Following a scientific review of the available information, Health Canada has determined that the health and environmental risks and the value of trinexapac-ethyl continue to be acceptable provided the required mitigation measures and label updates are implemented. Label amendments, as summarized below and listed in Appendix II of the full version of RVD2022-12, are required.

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 trinexapac-ethyl, are summarized below. Refer to Appendix II of RVD2022-12 for details.

Human health

The following risk-reduction measures are proposed:

To protect mixer/loader/applicators:

• For use on perennial ryegrass grown for seed, require closed mixing/loading systems and closed cab groundboom application when handling more than 70 kg a.i./day.
• For all uses, update PPE label statements to reflect current standards.

To protect workers entering treated sites:

• For use on perennial ryegrass grown for seed, require an REI of 10 days for all postapplication activities.
• For use on sod farm, require an REI of 12 hours for all postapplication activities.
• For use on golf courses, restrict entry until residues have dried.

To protect/prevent bystander exposure:

• Prohibit the use of trinexapac-ethyl golf course treatment products from being used on turf in other residential areas (which includes lawns, gardens, parks, playing fields, cemeteries and schools).
• Add standard drift statement.

Environment

To protect terrestrial non-target plants and freshwater aquatic habitats, the following risk-reduction measures are required:

• A buffer zone of 1 meter is proposed for the protection of terrestrial non-target plants and freshwater aquatic habitats.
• Update Environmental precautions (spray drift) and disposal label statements to protect terrestrial non-target plants and freshwater aquatic habitats to reflect current standards.

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 this decision document. 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 this decision document 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 trinexapac-ethyl and its associated end-use products within 60 days from the date of publication of this Re-evaluation Decision. 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 Health Canada's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PRVD2022-01) are available for public inspection, upon application, in Health Canada's Reading Room. For more information, please contact Health Canada's Pest Management Information Service.

Appendix I Registered products containing trinexapac-ethyl in Canada

Table 1 Products containing trinexapac-ethyl requiring (label) amendments ^{Footnote 1}

Registration number	Marketing class	Registrant	Product name	Formulation type	Active ingredient
26988	Technical Grade Active Ingredient	Syngenta Canada Inc.	Trinexapac-Ethyl Technical	Liquid	97%
26989	Commercial		Primo Maxx Plant Growth Regulator	Emulsifiable Concentrate	11.3%
31214	Commercial		Parlay	Emulsifiable Concentrate	11.3%
33930	Commercial		Moddus	Micro- Emulsifiable Concentrate	11.3%
30635	Technical Grade Active Ingredient	Adama Agricultural Solutions Canada Ltd.	Adama Trinexapac Technical	Suspension	97.2%
30683	Commercial		Quali-Pro T-Nex 11.3 Me	Micro- Emulsifiable Concentrate	11.3%
33385	Commercial		Quali-Pro T-Nex 12 Me	Micro- Emulsifiable Concentrate	120 g/L
33358	Technical Grade Active Ingredient	Sharda Cropchem Limited	Sharda Trinexapac-Ethyl Technical	Liquid	99%
33883	Commercial		Next 11.2 ME	Micro- Emulsifiable Concentrate	11.3%
34056	Technical Grade Active Ingredient	Maxunitech North America, Inc.	Maxunitech Trinexapac-ethyl Technical	Liquid	98.6%
34065	Commercial		Maxunitech Trinexapac-ethyl 11.3% ME	Micro- Emulsifiable Concentrate	11.3%
Footnote 1 as of 30 May 2022, excluding discontinued products or products with a submission for discontinuation Return to footnote 1 referrer