Re-evaluation Decision RVD2020-11, Phosmet and its associated end-use products

Pest Management Regulatory Agency
30 October 2020
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2020-11E-PDF (PDF version)

Table of Contents

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

Re-evaluation decision for phosmet 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.

Phosmet is a non-systemic, broad-spectrum organophosphate insecticide used to control insect pests on a wide variety of agricultural crops: alfalfa, apple, blueberry, cherry (sour), cranberry, grape, pear, peach, plum, carrot, celery, potato and ornamental plants. Currently registered products containing phosmet can be found in the Pesticide Label Search and in Appendix I.

The Proposed Acceptability for Continued Registration Document PACR2004-38, Re-evaluation of Phosmet was published in 2004, proposing interim mitigation measures and requiring additional data. The Re-evaluation Note REV2007-14, Re-evaluation of Phosmet Interim Measures was published in 2007, implementing interim mitigation measures. The Proposed Re-evaluation Decision PRVD2017-07 Phosmet^{Footnote 1} containing the evaluation of phosmet and proposed decision, underwent a 90-day consultation period ending on 28 September 2017. PRVD2017-07 proposed to phase out the registration of all phosmet products due to health risks of concern.

Health Canada received comments and additional information including registrant supported revised use pattern. Commenters are listed in Appendix II of RVD2020-11. These comments are summarized in Appendix III of RVD2020-11 along with the responses by Health Canada. These comments and new data/information result in revisions to the occupational, residential, and environmental assessments (see Science evaluation update), and result in changes to the proposed re-evaluation decision as described in PRVD2017-07.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2017-07, and further information used in the re-evaluation decision is listed in Appendix VIII of RVD2020-11. Therefore, the complete reference list of all information used in this final re-evaluation decision includes both the information set out in the References section of the PRVD2017-07 and the information set out in Appendix VIII of RVD2020-11.

This document (RVD2020-11) presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of phosmet, 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 phosmet that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for phosmet

Health Canada has completed the re-evaluation of phosmet. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing phosmet is acceptable with additional risk mitigation measures. An evaluation of available scientific information found that some uses (fruit trees, berries, carrots, celery, potatoes and outdoor ornamentals not grown for cut flowers) of phosmet products meet current standards for protection of human health and the environment, and have acceptable value when used according to the revised conditions of use. The following uses of phosmet are cancelled since health risks were not shown to be acceptable:

• alfalfa, grape and outdoor ornamentals grown for cut flowers.

Label amendments, as summarized below and listed in Appendix VII of RVD2020-11, 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, to have acceptable value and must be followed by law. The required amendments, including any revised/updated label statements and/or mitigation measures, as a result of the re-evaluation of phosmet, are summarized below. Refer to Appendix VII of RVD2020-11 for details.

Cancelled uses to be removed from all product labels:

• Alfalfa, grapes, outdoor ornamentals grown for cut flowers

Cancelled use with an extended phase-out schedule:

One cancelled use was found to lack suitable alternatives for the control of Japanese beetle, for which growers would face significant challenges:

• Outdoor ornamentals grown for cut flowers.

As a result, the implementation of the re-evaluation decision for this cancelled use will be delayed for an additional two years to allow growers to find pest management solutions. During this extended period, the implementation of additional interim mitigation measures will be required when applying phosmet to this use. The risks to human health are therefore considered acceptable for an additional two years for this cancelled use.

General label improvements:

• Update and/or revise the use directions for retained uses according to required risk mitigation measures.

Human health

Risk mitigation:
To protect human health, the following risk-reduction measures are required for uses with continued registration (apple, blueberry, cherry (sour), cranberry, pear, peach, plum, carrot, celery, potato and ornamental plants not grown for cut flowers):

• To protect mixer/loader/applicators: require additional protective equipment and engineering controls when mixing/loading and applying to all crops, limit the amount of phosmet used per day for mechanically pressurized handguns in all crops, and prohibit use with handheld mistblower/fogger
• To protect workers entering treated sites: revised restricted-entry intervals (REIs), and require restrictions on number and timing of applications allowed per season for some crops.
• To protect the general public: prohibit use in residential areas, and require a statement to promote best management practices to minimize human exposure from spray drift or spray residues resulting from drift.

Interim Risk Mitigation:

To protect postapplication workers, the following interim risk-reduction measures are required for the cancelled use with an extended phase-out period (in other words, outdoor ornamentals grown for cut flowers):

• Limit to one application per season
• Limit the carrier spray volume to 300 L/ha in the application
• Require interim REIs ranging from 12 hours to 6 days for postapplication worker activities

Environment

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

• Phosmet is highly toxic to bees. Timing restrictions for application during bloom and hazard statements are required to minimize the potential risks to bees.
• Phosmet is toxic to aquatic organisms, birds and small wild mammals. Hazard statements are required on product labels to warn users of potential risks.
• Label statements are required to minimize potential risks for non-target arthropods.
• Buffer zones are required to mitigate potential risks to aquatic organisms resulting from spray drift.
• Standard label statements are required to minimize potential risks resulting from runoff.

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 RVD2020-11. 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 RVD2020-11 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 phosmet and its associated end-use products within 60 days from the date of publication of RVD2020-11. 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 confidential test data on which the decision is based (as referenced in PRVD2017-07 and in Appendix VIII of RVD2020-11) 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 phosmet in Canada

Table 1  Registered products containing phosmet in Canada requiring (label) amendments^{Footnote 1}

Registration number	Marketing class	Registrant	Product name	Formulation type	Active ingredient (%)
23055	Technical grade active ingredient	Gowan Company LLC	Phosmet Technical	Solid	96
23006	Commercial		Imidan 50-WP Instapak	Wettable powder	50
29064			Imidan WP Insecticide		70
Footnote 1 as of 22 June 2020, excluding discontinued products or products with a submission for discontinuation Return to footnote 1 referrer