Re-evaluation Decision RVD2023-15, 1-Methylcyclopropene and Its Associated End-use Products

• Pest Management Regulatory Agency
• 26 September 2023
• ISSN: 1925-1025 (PDF version)
• Catalogue number: H113-28/2023-15E-PDF (PDF version)

Summary

Table of Contents

• Re-evaluation decision for 1-methylcyclopropene and associated end use products
• Re-evaluation decision for 1-methylcyclopropene
• Risk mitigation measures
• Next steps
• Other information
• Appendix I Registered products containing 1-methylcyclopropene in Canada

Re-evaluation decision for 1-methylcyclopropene and associated end use products

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

1-Methylcyclopropene is a plant growth regulator that inhibits production of ethylene, a plant hormone that promotes fruit ripening and senescence. It is registered for use as postharvest (in storage) and preharvest uses.

• Postharvest: 1-Methylcyclopropene is used as a fumigation treatment in airtight treatment area (container or room) to preserve potted and cut flowers, ornamental plants and fruits (apples, bananas, pears and tomatoes).
• Preharvest: 1-Methylcyclopropene is applied as a foliar/fruit spray in apple orchards, 3 to 21 days prior to apple harvest using ground application equipment to delay fruit maturation and prevents fruit drop.

Currently registered products containing 1-methylcyclopropene can be found in the Pesticide Product Information Database and in Appendix I.

The Proposed Re-evaluation Decision PRVD2022-05 1-Methylcyclopropene and Its Associated End-use Products^{Footnote 1} containing the evaluation of 1-methylcyclopropene, underwent a 90-day consultation period ending on 22 June 2022. PRVD2022-05 proposed continued registration of 1-methylcyclopropene products for sale and use in Canada, with label updates to meet current labelling standards.

Health Canada received two comments relating to the PRVD2022-05. Commenters are listed in Appendix II of RVD2023-15. The comments are summarized in Appendix III of RVD2023-15 along with the responses by Health Canada. The comments did not result in revisions to the assessments and did not result in changes to the proposed re-evaluation decision as outlined in PRVD2022-05. A reference list of information used as the basis for the re-evaluation decision is included in PRVD2022-05 and this decision document (Appendix V of RVD2023-15).

This document (RVD2023-15) presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of 1-methylcyclopropene, including the label updates required to meet the current labelling standards. All products containing 1-methylcyclopropene that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for 1-methylcyclopropene

Health Canada has completed the re-evaluation of 1-methylcyclopropene. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing 1-methylcyclopropene is acceptable. An evaluation of available scientific information found that the use of 1-methylcyclopropene products meets current standards for protection of human health and the environment and has acceptable value when used with label updates outlined below.

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 updated label statements, as a result of the re-evaluation of 1-methylcyclopropene, are summarized below. Refer to Appendix IV of RVD2023-15 for details.

Human health

• Updated standard label statements related to personal protective equipment.

Environment

• Updated standard label statements relating to disposal.

Next steps

To comply with this decision, the required amendments (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 1-methylcyclopropene 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 PRVD2022-05 and Appendix V of RVD2023-15) 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 1-methylcyclopropene in Canada

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

Registration number	Marketing class	Registrant	Product name	Formulation type	Active ingredient (%)
27777	Technical	AgroFresh Inc.	1-Methylcyclopropene (1-MCP) Technical	Gas	97.2
33071	Technical	Janssen Pharmaceutica NV	Fysium Technical	Pressurized Product	98.0
33888	Technical	Fine Agrochemicals Limited	Fine 1-MCP Technical	Gas	98.93
34547	Technical	Pace International, LLC	Pace 1-MCP	Gas	98.5
27778	Commercial	AgroFresh Inc.	SmartFresh Technology	Dust or Powder	3.3
28438	Commercial	AgroFresh Inc.	EthylBloc Technology	Soluble Powder	0.14
28569	Commercial	AgroFresh Inc.	SmartFresh Technology for Tomatoes	Dust or Powder	3.3
28781	Commercial	AgroFresh Inc.	SmartFresh SmartTabs	Tablet	0.63
30872	Commercial	AgroFresh Inc.	SmartFresh ProTabs	Tablet	2.0
31590	Commercial	AgroFresh Inc.	Ripelock Tabs 2.0	Tablet	2.0
32752	Commercial	AgroFresh Inc.	Harvista 1.3 SC	Suspension	1.3
33072	Commercial	Janssen Pharmaceutica NV	Fysium	Dust or Powder	98
33215	Commercial	AgroFresh Inc.	EthylBloc Sachet	Wettable Granules	0.014
33261	Commercial	AgroFresh Inc.	Ethylene Buster Sachets	Wettable Granules	0.014
34124	Commercial	Fine Agrochemicals Limited	Easyfresh	Dust or Powder	3.3
34549	Commercial	Pace International, LLC	Freshvue Pods	Soluble Powder	3.3

Table 2 Products containing 1-methylcyclopropene not requiring (label) amendments ^{Table 2 Footnote 1}

Registration number	Marketing class	Registrant	Product name	Formulation type	Active ingredient (%)
32751	Manufacturing concentrate	AgroFresh Inc.	1-Methylcyclopropene MUP - HAIP	Wettable Powder	4.5