Re-evaluation Decision RVD2020-09, Ethephon and its associated end-use products

Pest Management Regulatory Agency
24 September 2020
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2020-9E-PDF (PDF version)

Table of contents

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

Re-evaluation decision for ethephon 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.

Ethephon is a systemic plant growth regulator intended to promote fruit ripening/maturity, and plant growth and development, through the release of ethylene gas, a natural plant hormone. It is applied to promote early and uniform fruit maturity in apples, tomatoes, blueberries, and cherries; reduces tobacco kiln curing time; and reduces lodging in barley and wheat. Ethephon is used for potted greenhouse ornamental production to ensure uniform flowering for market sales. Currently registered products containing ethephon can be found in the Pesticide Label Search and in Appendix I.

The Proposed Re-evaluation Decision PRVD2018-01, Ethephon and Its Associated End-use Products^{Footnote 1} containing the evaluation of Ethephon and proposed decision, underwent a 90 day consultation period ending on 26 April 2018. PRVD2018-01 proposed that products containing ethephon are acceptable for continued registration in Canada, provided that the additional proposed risk mitigation measures are in place. The proposed risk mitigation measures included:

• the cancellation of the uses on apple trees when fruit are present;
• revocation of existing maximum residue limits (MRLs) for apple, apple juice, citrus fruit, grape, and raisins;
• requirement for additional personal protection equipment (PPE) and engineering controls when mixing/loading and applying;
• restrictions on amount of active ingredient handled per day; longer restricted-entry intervals (REIs) for some postapplication activities; statements to minimize human exposure from spray drift;
• environmental hazard statements; terrestrial spray buffer zones, and standard runoff statements.

Health Canada received comments (and information) relating to the health and value assessments. Commenters are listed in Appendix II of Re-evaluation Decision RVD2020-09, Ethephon and its associated end-use products. These comments are summarized in Appendix III of RVD2020-09 along with the responses by Health Canada.

The comments and new data/information did result in revisions to the dietary and occupational risk assessments (see Science evaluation update of RVD2020-09), and did result in changes to the proposed re-evaluation decision as described in PRVD2018-01.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2018-01, and further information used in the re-evaluation decision is listed in Appendix VIII of RVD2020-09. Therefore, the complete reference list of all information used in this final re-evaluation decision includes both the information set out in PRVD2018-01 and the Information set out in Appendix VIII of RVD2020-09.

This document (RVD2020-09) presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of ethephon, including the required amendments (risk mitigation measures) to protect human health and the environment, and any label amendments required to bring labels to current standards. All products containing ethephon that are registered in Canada are subject to RVD2020-09.

Re-evaluation decision for ethephon

Health Canada has completed the re-evaluation of ethephon. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing ethephon is acceptable. An evaluation of available scientific information found that some uses of ethephon 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 use of ethephon is cancelled since health risks were not shown to be acceptable: use on apple trees when fruit are present. Label amendments, as summarized below and listed in Appendix VII of RVD2020-09, 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 label statements and mitigation measures, as a result of the re-evaluation of ethephon, are summarized below. Refer to Appendix VII of RVD2020-09 for details.

Human health

Risk mitigation

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

• Cancellation of uses on apple trees when fruit are present. The use on apple trees, when fruit are not present, is retained.
• Revocation of the existing maximum residue limits (MRLs) for apple juice, apples, and citrus fruits such that they will be subject to the general maximum residue limit (GMRL).
• Requirement for additional personal protection equipment (PPE) and engineering controls when mixing/loading and applying to various crops.
• Restrictions on amount of active ingredient handled per day.
• Requirement for longer restricted-entry intervals (REIs) for some postapplication activities.
• Requirement for a statement to promote best management practices to minimize human exposure from spray drift or spray residues resulting from drift.

Environment

Risk mitigation

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

• Environmental hazard statements for birds, mammals and non-target plants.
• To reduce the potential for runoff of ethephon to adjacent aquatic habitats, precautionary
  statements for sites with characteristics that may be conducive to runoff and when heavy
  rain is forecasted are required. In addition, a vegetative strip between the treatment area
  and the edge of a water body is required to reduce runoff of ethephon to aquatic
  areas
• Terrestrial spray buffer zones for the protection of non-target plants.

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 RVD2020-09. Accordingly, both registrants and retailers will have up to 24 months from the date of RVD2020-09 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 RVD2020-09 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 ethephon and its associated end-use products within 60 days from the date of publication of RVD2020-09. 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 PRVD2018-01 and in Appendix VIII of RVD2020-09) are available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa). For more information, please contact the PMRA's Pest Management Information Service.

Appendix I Registered products containing ethephon in Canada

Table 1 Registered products containing ethephon requiring label amendments^{Footnote 1}

Registration Number	Marketing Class	Registrant	Product Name	Formulation Type	Active ingredient (%, g/L)
19205	Technical	Bayer CropScience Inc.	Technical Ethephon	Solid	Ethephon: 90.22%
19206	Manufacturing Concentrate	Bayer CropScience Inc.	Base 250	Solution	Ethephon: 71.3% by weight
11580	Commercial	Bayer CropScience Inc.	Ethrel Liquid Plant Growth Regulator	Solution	Ethephon: 240 g/L
18685	Commercial	Bayer CropScience Inc.	Cerone Brand Plant Regulator Lodging Control for Cereals	Solution	Ethephon: 480 g/L
29593	Commercial	Bayer CropScience Inc.	Florel Plant Growth Regulator	Solution	Ethephon: 240 g/L
30686	Commercial	Bayer CropScience Inc.	Proxy Plant Growth Regulator	Solution	Ethephon: 240 g/L