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)

Summary

Table of Contents

• Re-evaluation decision
• Outcome of science evaluation
• Regulatory decision for acephate
• Risk mitigation measures
• Next steps
• Other information
• Appendix I Registered acephat products in Canada as of December 2019

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 decision^{Footnote 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:

• Greenhouse cut flowers (based on stakeholder comments on feasibility)
• Outdoor cut flowers (based on lower rates resulting from environmental mitigation measures)

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:

• Updated toxicological information with additional information about symptoms
  and treatment for overexposed individuals.

Risk mitigation:

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

• To protect mixer/loaders and applicators, cancellation of the soluble powder formulation product. Uses registered for this product have been transferred to the label of a soluble granule product. Additional mitigation measures identified in the present decision are to be added to the latest registered label of the soluble granule product.
• Prohibition of applications by handheld mist blower or handheld fogger.
• Revised restricted-entry intervals (REIs) to protect workers entering treated sites.
• Prohibition of foliar application to all trees and ornamentals in residential areas, which include municipal parks.
• Cancellation of use on potatoes.
• Reduction in application rate, maximum number of applications per year, and increase in minimum application intervals for certain crops to address food and drinking water risk concerns.

Environment

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

• Cancellation of airblast/outdoor mist blower applications and associated application rate, which are currently registered for use on various trees and ornamentals, and in Christmas tree plantations, farm woodlots, nurseries, shelter belts, rights-of-way and municipal parks.
• Restriction of foliar applications in farm woodlots, shelter belts, and rights-of-way to spot treatments using hand-held equipment only.
• Precautionary and hazard statements to inform users of the toxicity and potential risk of acephate to pollinators, beneficial arthropods, birds, mammals, and aquatic organisms.
• Prohibition of tree injection applications until after the blooming/pollen shedding period.
• Prohibition of applications during periods of bloom or during the 9-day period before crop bloom for crops that are attractive to pollinators (or for other crops when using managed bees for pollination services).
• A label statement directing users not to discharge acephate-contaminated effluent from greenhouses into aquatic environments.

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:

• One (1) year of sale by registrant from the publication date of this decision document, followed by;
• One (1) year of sale by retailer from the last date of sale by registrant, followed by;
• One (1) year of permitted use from the last date of sale by retailer.

Other information

Any person may file a notice of objection^{Footnote 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 (pmra.info-arla@hc-sc.gc.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%