Re-evaluation Decision RVD2020-07, Acephate and Its Associated End-use Products

Pest Management Regulatory Agency
April 3, 2020
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2020-7E-PDF (PDF version)

To obtain a full copy of Re-evaluation Decision RVD2020-07 Acephate and Its Associated End-use Products please contact our publications office.

Should you require further information please contact the Pest Management Information Service.

Summary

Table of Contents

Re-evaluation decision

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 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. The PMRA applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Acephate is a systemic organophosphate insecticide registered to control a broad spectrum of insect pests on a wide variety of crops and use sites, including forest and woodlots, terrestrial food and feed crops, and outdoor ornamentals. Currently registered products containing acephate can be found in the Pesticide Label Search and in Appendix I. A proposed re-evaluation decision for acephate was published in 2016 (PRVD2016-01, Acephate) and an updated environmental risk assessment in 2019 (PRVD2019-04, Acephate and Its Associated End-use Products, Updated Environmental Risk Assessment). Both consultation documents underwent 90-day consultation periods.

The proposed regulatory decision pertaining to human health was presented in PRVD2016-01 in which a prohibition of foliar application in residential areas, the cancellation of uses on potatoes, and the replacement of the soluble powder formulation with a soluble granule formulation were proposed. PRVD2019-04 describes the complete environmental risk assessment with additional proposed mitigation measures including the cancellation of all airblast/outdoor mistblower applications, restrictions in application timing relative to blooming periods, and limiting applications in farm woodlots, shelter belts, rights of way and municipal parks to spot treatments with hand-held equipment. Updated label statements were also proposed to inform users of ways to reduce potential environmental risks.

Health Canada received comments and information relating to the health and environmental assessments. Refer to Appendix II of RVD2020-07 for a list of respondents, and summarized comments with responses by Health Canada. The comments and information resulted in some revisions to the risk assessments (see Science Evaluation Update of RVD2020-07) and changes to the proposed regulatory decision as described in PRVD2016-01. Reference lists for the information used in the proposed re-evaluation decisions are found in PRVD2016-01 and PRVD2019-04. Appendix VI of of RVD2020-07 lists additional information used in the final re-evaluation decision.

This document (RVD2020-07) presents the final regulatory decisionFootnote 1 for the re-evaluation of acephate, including required risk mitigation measures to protect human health and the environment and label amendments to bring labels up to current standards. All products containing acephate that are registered in Canada are subject to this re-evaluation decision.

Outcome of science evaluation

Based on information received during the comment period for the proposed re-evaluation decision, Health Canada has made revisions to certain aspects of the health and environmental risk assessments. The following uses, which had been proposed for cancellation in PRVD2016-01, are now considered to be acceptable:

With some exceptions, health and environmental risks have been shown to be acceptable for uses of acephate and its associated end-use products when revised label directions and other mitigation measures are followed. Uses for which risks have not been shown to be acceptable are being cancelled.

Regulatory decision for acephate

Health Canada has completed the re-evaluation of acephate. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of certain products containing acephate is acceptable. An evaluation of available scientific information found that most uses of acephate products meet current standards for protection of human health and the environment when used according to revised label directions, which include new mitigation measures. Certain uses and application methods for acephate are being cancelled to address potential risks of concern to human health and the environment. Label amendments, as summarized below and listed in Appendix III of RVD2020-07, are required. No additional data are required at this time.

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 revised label statements and mitigation measures required as a result of the re-evaluation of acephate are summarized below. Refer to Appendix III of RVD2020-07 for details.

Human health

Label improvements to meet current standards:

Risk mitigation:

To protect human health, the following risk-reduction measures are required for continued registration of acephate in Canada:

Environment

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

Next steps

To comply with this decision, the required mitigation measures must be implemented on all product labels sold by registrants no later than 24 months after the publication date of this decision document. Refer to Appendix I for specific products impacted by this decision. Products that are cancelled will be phased out according to the following implementation timeline:

Other information

Any person may file a notice of objectionFootnote 2 regarding this decision on acephate within 60 days from the date of publication of RVD2020-07. 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 (hc.pmra.info-arla.sc@canada.ca).

The relevant test data on which the decision is based 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 acephate products in Canada as of December 2019

Table 1 Products requiring label amendments
Registration Number Marketing Class Registrant Name Product
Name
Formulation Type Active Ingredient
21568 Commercial Arysta LifeScience North America, LLC Acecap 97 Systemic Insecticide Implants soluble powder Acephate 0.773g per cartridge
22109 Technical Orthene Technical soluble powder Acephate 99.78%
27917 Technical Acephate Technical soluble powder Acephate 98.0%
29499 Commercial Orthene 97% Soluble Granule Systemic Insecticide Soluble granule Acephate 97%
Table 2 Products Being Cancelled
Registration Number Marketing Class Registrant Name Product
Name
Formulation Type Active Ingredient
14225 Commercial Arysta LifeScience North America, LLC Orthene 75% Soluble Powder Systemic Insecticide soluble powder 75%

Footnotes

Footnote 1

“Decision statement” as required by subsection 28(5) of the Pest Control Products Act.

Return to footnote 1 referrer

Footnote 2

As per subsection 35(1) of the Pest Control Products Act.

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