Re-evaluation decision RVD2024-03, Quizalofop-p-ethyl and its associated end-use products

• Pest Management Regulatory Agency
• 23 February 2024
• ISSN: 1925-1025 (PDF version)
• Catalogue number: H113-28/2024-3E-PDF (PDF version)

Summary

Table of Contents

• Re-evaluation decision for quizalofop-p-ethyl and associated end-use products
• Re-evaluation decision for quizalofop-p-ethyl
• Risk mitigation measures
• Implementation of the re-evaluation decision
• Health considerations
• Environmental considerations
• Next steps
• Other information
• Appendix I Registered products containing quizalofop-p-ethyl in Canada

Re-evaluation decision for quizalofop-p-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 meet current health and environmental standards and 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. More details, on the legislative framework, risk assessment and risk management approach, are provided under the Evaluation Approach section of this document.

Quizalofop-p-ethyl is a selective systemic, grass-controlling herbicide registered for postemergent control of annual and perennial grass weeds in a variety of crops such as major field crops, cucurbit vegetables, horticultural crops, forage crops for seed production and many minor specialty crops including industrial hemp grown for fibre, seed and oil. It is applied using ground or aerial equipment. Quizalofop-p-ethyl has value in providing effective control of perennial grass weeds and it is the only herbicide registered for use on hemp and Ethiopian mustard. Currently registered products containing quizalofop-p-ethyl can be found in the Pesticide Product Information Database and in Appendix I.

The Proposed Re-evaluation Decision PRVD2022-17, Quizalofop-p-ethyl and Its Associated End-use Products ^{Footnote 1} containing the evaluation of quizalofop-p-ethyl and proposed decision, underwent a 90 day consultation period ending on 27 October 2022. PRVD2022-17 proposed that products containing quizalofop-p-ethyl are acceptable for continued registration in Canada, provided that the proposed risk mitigation measures are in place. The proposed risk mitigation measures included updates to personal protective equipment for mixers, loaders and applicators, standard restricted-entry intervals, re-treatment and preharvest intervals (PHIs), a best practice label statement to minimize the potential for spray drift, and precautionary environmental statements and spray buffer zones for the protection of terrestrial and aquatic habitats.

Four comments were received from the public indicating that pesticides, in general, harm human health and or the environment. No comments specific to the assessments and proposed risk mitigation measures presented in PRVD2022-17 were received. Therefore, this decision is consistent with the proposed re-evaluation decision stated in PRVD2022-17, which lists all information used as the basis for the re-evaluation decision.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2022-17; no further information was used in the final re-evaluation decision. Therefore, the complete reference list of all information used in this final re-evaluation decision is set out in PRVD2022-17.

This document (Re-evaluation decision RVD2024-03, Quizalofop-p-ethyl and its associated end-use products) presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of quizalofop-p-ethyl, 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 quizalofop-p-ethyl that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for quizalofop-p-ethyl

Health Canada has completed the re-evaluation of quizalofop-p-ethyl. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing quizalofop-p-ethyl is acceptable. An evaluation of available scientific information found that the uses of quizalofop-p-ethyl 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. Label amendments, as summarized below and listed in Appendix II of the full version of RVD2024-03, 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 as a result of the re-evaluation of quizalofop-p-ethyl, are summarized below. Refer to Appendix II of RVD2024-03for details.

Human health

Label improvements to meet current standards:

• A re-treatment interval of 14 days is required for the use on sugarbeets. Additionally, the registered uses on Oriental mustard (including canola quality brassica juneca) (condiment and oilseed type), yellow mustard, brown mustard, crambe, and chickpeas do not have specified PHIs on all current labels. New PHIs are indicated in Appendix II of RVD2024-03.

Risk mitigation:

To protect workers (mixer/loader/applicator), bystanders, and those entering treated areas from exposure, the following risk-reduction measures are required for continued registration of quizalofop-p-ethyl products in Canada:

• Updates to personal protective equipment (PPE) label statements as per current labeling standards.
• A standard restricted-entry interval (REI) of 12 hours is required to protect workers entering treated areas, unless a more restrictive REI is specified on the labels.
• A standard drift mitigation statement is required to minimize the potential for spray drift to bystanders.

Environment

Label improvements to meet current standards:

• Updated discharge of effluent statements.
• Updated disposal statements.
• Updated use directions and use precautions.
• Precautionary label statement to inform users of the presence of petroleum distillates in quizalofop-p-ethyl products, and their toxicity to aquatic organisms.

Risk mitigation:

To protect the environment, the following risk-reduction measures are required:

• Precautionary statements are required to inform users of the toxicity of quizalofop-p-ethyl to aquatic organisms and terrestrial plants.
• Updated spray buffer zones for the protection of non-target terrestrial and aquatic habitats.
• Precautionary label statements regarding the potential for runoff to adjacent aquatic habitats for sites with characteristics that may be conductive to runoff and when heavy rain is forecast.

Implementation of the re-evaluation decision

Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review provides general timelines for implementation of post-market decisions.

Health considerations

When conducting human health risk assessments, risks from exposure to a pesticide are estimated by comparing potential exposures with the most relevant endpoint from toxicology studies, with standard protection factors incorporated to further protect human health, including the most sensitive population. These factors provide an inherent level of protection from exposures that could result in adverse effects to human health. Furthermore, Health Canada applies additional protection factors if warranted by the hazard profile of the pesticide or by the quality and completeness of the underlying data. When risks of concern are identified in the human health exposure scenarios, it does not necessarily mean that exposure will result in adverse effects, but mitigation measures to reduce potential risks would be required in order to support continued registration of the product/use.

Potential and relative health risks are thus considered acceptable during the general 2-year implementation period unless there is evidence from incident reports or other sources of real-world post-market surveillance data suggesting that there are adverse health effects occurring as a result of the use of the product(s) according to the currently approved label/use conditions. Other considerations may include how widely the product is used, the populations potentially exposed to the product and/or other factors.

Environmental considerations

The re-evaluation for quizalofop-p-ethyl did not identify any additional environmental risks and did not result in a recommendation for a reduction or change in any uses based on the environmental assessment.

Taking into consideration these factors, the general 2-year implementation timeline for label amendments for quizalofop-p-ethyl is considered appropriate from a human health and environmental perspective. Therefore, the required label updates will be implemented within 24 months following the publication of the re-evaluation decision document.

Refer to Appendix I for details on specific products impacted by this decision.

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 RVD2024-03. Accordingly, both registrants and retailers will have up to 24 months from the date of RVD2024-03 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 RVD2024-03 to transition to using the newly amended labels, which will be available on the Public Registry.

Other information

Any person may file a notice of objection^{Footnote 3} regarding this decision on quizalofop-p-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 PMRA's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PRVD2022-17) are available for public inspection, upon application, in PMRA's Reading Room. For more information, please contact the Pest Management Information Service.

Appendix I Registered products containing Quizalofop-p-ethyl in Canada

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

Registration number	Marketing classTable 1 Footnote 2	Registrant	Product name	Formulation type	Guarantee
25461	T	AMVAC Canada ULC	Quizalofop-p-ethyl Technical Herbicide	Solid	98%
29392	T	Nissan Chemical Corporation	Quizalofop-p-ethyl MUP Herbicide	Solid	98%
33269	T	Sharda Cropchem Limited	Sharda Quizalofop-p-ethyl Technical Herbicide	Solid	95.7%
33340	T	Adama Agricultural Solutions Canada Ltd.	Adama Quizalofop-p-ethyl Technical	Solid	95.67%
33374	T	NewAgco Inc.	Newagco Quizalofop-p-ethyl Technical	Solid	98%
33730	T	Agrocill Chemicals Pty Ltd.	Quizalofop-p-ethyl Agrogill Technical Grade Active Ingredient	Solid	98.8%
34910	T	Zhejiang Xinan Chemical Industrial Group Co., Ltd.	Wynca Quizalofop-p-ethyl Technical	Solid	98.5%
34944	T	Farmer's Business Network Canada Inc.	Quizalofop Technical	Solid	97.5%
30068	M	Nissan Chemical Corporation	YumaTM Bulk Herbicide	Emulsifiable concentrate	96 g/L
34743	M	UPL Agrosolutions Canada Inc.	Select Plus Bulk	Emulsifiable concentrate	120 g/L
25462	C	AMVAC Canada ULC	Assure II Herbicide	Emulsifiable concentrate	96 g/L
29134	C	Nissan Chemical Corporation	Yuma Herbicide	Emulsifiable concentrate	96 g/L
30100	C	Nissan Chemical Corporation	Yuma®GL Liquid EC Herbicide	Emulsifiable concentrate	96 g/L
32091	C	Nissan Chemical Corporation	Ipco Contender Herbicide	Emulsifiable concentrate	96 g/L
33481	C	NewAgo Inc.	Quiz Herbicide	Emulsifiable concentrate	96 g/L
33617	C	Sharda Cropchem Limited	Elegant10 EC	Emulsifiable concentrate	96 g/L
33681	C	Nissan Chemical Corporation	Marshall	Emulsifiable concentrate	96 g/L
33715	C	ADAMA Agricultural Solutions Canada Ltd.	Leopard	Emulsifiable concentrate	100 g/L
33835	C	Agrogill Chemicals Pty Ltd.	Agrogill Quizalofop-p-ethyl Herbicide	Emulsifiable concentrate	96 g/L
33906	C	Nufarm Agriculture Inc.	Idol Herbicide	Emulsifiable concentrate	96 g/L
33960	C	Interprovincial Cooperative Ltd.	IPCO Contender II Herbicide	Emulsifiable concentrate	96 g/L
33961	C	Interprovincial Cooperative Ltd.	Co-op Contender II Herbicide	Emulsifiable concentrate	96 g/L
34034	C	NewAgco Inc.	Quizalofop-p-ethyl 96 G/L Herbicide	Emulsifiable concentrate	96 g/L
34282	C	BASF Canada Inc.	CazivaTM Ultra Q	Emulsifiable concentrate	96 g/L
34744	C	UPL Agrosolutions Canada Inc.	Select Plus	Emulsifiable concentrate	120 g/L
34759	C	Viking Crop Production Partners Inc.	Viking Quizalofop Herbicide	Emulsifiable concentrate	96 g/L
34935	C	Adama Agricultural Solutions Canada Ltd.	Adama Quizalofop	Emulsifiable concentrate	100 g/L