Proposed Re-evaluation Decision PRVD2017-07, Phosmet

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The online consultation is now closed.

Pest Management Regulatory Agency
30 June 2017
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2017-7E-PDF (PDF version)

This page is a summary of the consultation document. If you would like to comment, please request the full consultation document.

To obtain a full copy of Proposed Re-evaluation Decision PRVD2017-07, Phosmet please contact our publications office.

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

Summary

Table of Contents

Executive Summary

Health Canada's Pest Management Regulatory Agency (PMRA)

Health Canada's primary objective in regulating pesticides is to protect Canadians' health and their environment. Pesticides must be registered by Health Canada's Pest Management Regulatory Agency (PMRA) before they can be imported, sold, or used in Canada. Before being approved for registration, pesticides must go through rigorous science-based human health, environmental and value assessments.

Under the Pest Control Products Act, all registered pesticides must be re-evaluated by the PMRA on a cyclical basis to make sure that they continue to meet modern health and environmental safety standards and continue to have value. This may happen sooner if there have been changes in the required information or to the risk assessment methodology. Re-evaluations may result in:

  • changes to how products are used;
  • changes to product labels to meet current health and environmental standards; or,
  • removing products from the market to prevent future harm to health or the environment.

The re-evaluation considers all available information, including data from pesticide manufacturers, published scientific reports, information from other regulatory agencies and other available, relevant information. To reach its decisions, the PMRA applies internationally accepted hazard and risk assessment methods and modern risk management approaches and policies. For more information on how the PMRA regulates pesticides, as well as the assessment process, please visit the Pesticides and Pest Management portion the Canada.ca website.

Re-evaluation of Phosmet

Phosmet is an insecticide used to control insect pests on ornamental plants and a wide variety of agricultural crops including alfalfa, fruits and vegetables.

Proposed Re-evaluation Decision PRVD2017-07, Phosmet presents an updated human health risk assessment for phosmet, based on the additional information submitted to the PMRA by the registrant.

Key Findings

When considering all the currently available information, the human health risk assessment identified concerns for workers handling phosmet during its application and for people conducting post-application activities such as hand harvesting and thinning. The level of precaution needed to lower potential postapplication risks to an acceptable level is not feasible. Therefore, PMRA is proposing to phase-out the registration of phosmet products.  

Next Steps

The proposed re-evaluation decision is now open for public consultation for 90 days from the date of the publication of Proposed Re-evaluation Decision PRVD2017-07, Phosmet. Once the PMRA considers the comments and any information received during the public consultation period, it will publish a final decision.

Overview

What is the Proposed Re-evaluation Decision for Phosmet?

Using all currently available information and most recent risk assessment methods, the PMRA has identified potential risks of concern to human health that cannot be reduced through feasible label directions. For this reason, the PMRA is proposing to phase out all uses of phosmet.

Before making a final re-evaluation decision on phosmet, the PMRA will accept and consider written comments and additional data received up to 90 days from the date of PRVD2017-07, Phosmet. Please forward all comments to Publications . The PMRA will consider any additional data/information submitted during the consultation period in the final decision.

What Does Health Canada Consider When Making a Re-evaluation Decision?

Under the Pest Control Products Act, all registered pesticides must be re-evaluated by the PMRA on a cyclical basis to make sure that they continue to meet modern health and environmental safety standards and continue to have value. The re-evaluation considers data from pesticide manufacturers, published scientific reports, information from other regulatory agencies and other available, relevant information. To reach its decisions, the PMRA applies internationally accepted hazard and risk assessment methods and modern risk management approaches and policies.

For more information on how the PMRA regulates pesticides, as well as the assessment process, please visit the Pesticides and Pest Management portion of the Canada.ca website.

What is Phosmet?

Phosmet is an organophosphate insecticide used to control insect pests on ornamental plants and a wide variety of agricultural crops including alfalfa, fruits and vegetables. There are currently two end-use products containing phosmet registered for commercial use in Canada:

  • IMIDAN 50-WP INSTAPAK (Registration Number 23006)
  • IMIDAN 70-WP INSTAPAK (Registration Number 29064)

Health Considerations

Can Approved Uses of Phosmet Affect Human Health?

PMRA's assessment identified risks of concern for workers entering treated sites, and from residential exposures to phosmet. Based on the currently available information, there are no feasible measures to address these concerns. Therefore, all uses of phosmet are proposed for phase-out.

Potential exposure to phosmet may occur through the diet (food and drinking water), when handling and applying products containing phosmet or when coming in contact with treated plants. When assessing health risks, two key factors are considered:

  • the levels where no health effects occur and
  • the levels to which people may be exposed.

The dose levels used to assess risk are established to protect the most sensitive human population (that is, children and nursing mothers). As such, sex and gender are taken into account in the risk assessment. Only uses for which exposure is well below the levels that cause no effects in animal testing are considered acceptable for registration.

In laboratory animals, phosmet had high acute toxicity via the oral route of exposure, moderate acute toxicity via the inhalation route and low acute toxicity via the dermal route. Phosmet caused moderate eye irritation and did not cause allergic skin reactions.

The PMRA assessed short- term and long-term (lifetime) animal toxicity tests supplied by the registrant as well as information from published scientific literature to evaluate the potential of phosmet to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The risk assessment takes these potential effects into account in determining the allowable level of human exposure to phosmet.

Residues in Food and Drinking Water

Dietary risks from food and drinking water are not of concern.

The dietary assessment took into consideration the potential for exposure to phosmet residues in treated crops and animal commodities (including imports), and drinking water for the general population and different subpopulations. No acute, chronic and cancer risks of concern were identified.

Occupational Risks

Risks to handlers are of concern for some uses, but these potential risks can be mitigated.

Risks to farmers and workers who mix, load and apply phosmet for crops (fruits, vegetables, ornamentals and alfalfa) are of concern for some scenarios. However, these potential risks can be effectively mitigated using additional personal protective clothing and engineering controls (such as protective headgear and/or closed cabs). In some cases, limiting the amount of product that can be used per day can mitigate the risks.

Risks to workers entering treated sites are of concern, and mitigation is not considered to be feasible. In order to address these potential concerns, all uses of phosmet are proposed for phase-out.

Occupational post-application risk assessments consider exposure to workers entering treated sites in agriculture and other scenarios. Based on the precautions and directions for use on the current product labels, post-application risks to workers performing activities such as thinning, pruning and harvesting of crops are of concern. Occupational post-application risks can be mitigated by increasing the amount of time before safely re-entering a treated site. However, the restricted-entry intervals (REIs) proposed to mitigate post-application risks range from 12 hours to 79 days and are not considered to be feasible. As a result, all uses of phosmet are proposed for phase-out.

Risks in Residential and Other Non-Occupational Environments

Residential risks are of concern following commercial application to fruit trees and gardens in residential areas. In order to address these concerns, these uses of phosmet are proposed for phase-out.

There are currently no domestic phosmet products registered in Canada. Therefore, a risk assessment for residential handlers was not required.

Commercial application of phosmet to residential ornamentals and fruit trees could lead to exposure for people working in their home gardens. Risk assessments for such activities identified cancer and non-cancer risks of concern. Consequently, commercial application to residential ornamentals and fruit trees is proposed for phase-out.

Exposure to people who enter pick-your-own establishments following commercial application of phosmet to fruit trees or berries was not assessed, since the proposed REIs for commercial post-application workers (orchards, blueberries) are already not considered to be feasible.

Agricultural application of phosmet may result in spray drift. Studies that sampled the air surrounding agricultural areas in the United States during the spray season indicate that phosmet can be present in ambient air. Non-cancer and cancer risk estimates based on phosmet air concentrations are not of concern.

Aggregate risk estimates were not conducted due to existing non-cancer and cancer risk concerns from non-occupational exposures.

Environmental Considerations

When used according to the proposed label directions, phosmet is not expected to pose risks of concern to the environment.

The environmental fate and toxicity of phosmet was previously considered in PACR2004-38 and REV2007-14. Label statements for the protection of pollinators would need to be updated to meet current standards. However, at this time, the PMRA is proposing to phase out all uses of phosmet as a result of the human health risk assessment.

Value Considerations

What is the Value of Phosmet?

Phosmet plays an important role in insect pest management in Canadian agricultural production.

Phosmet is used on a wide variety of agricultural crops, including alfalfa, fruits and vegetables, and is also used on ornamental plants. For some crops, phosmet is the only approved insecticide to control specific pests. Furthermore, phosmet contributes to insecticide resistance management by helping to delay the development of insect resistance when used in rotation with insecticides having a different mode of action.

Proposed Measures to Minimize Risk

Based on the currently available information and most recent risk assessment methods, there are no feasible measures to reduce the risk to an acceptable level for people entering treated sites to conduct activities such as hand harvesting and thinning. Therefore, the PMRA is proposing to phase out all uses of phosmet.

What Additional Scientific Information Is Requested?

Since the phase-out of all uses is proposed as a result of the human health risk assessment, no additional data are required at this time.

Next Steps

During the consultation period, registrants and stakeholder organizations may submit further data that could be used to refine risk assessments, which could result in revised risk-reduction measures. Stakeholders who are planning to provide information of this type are advised to contact the PMRA early in the consultation period, for advice on studies or information that could be submitted to help refine the relevant risk assessments. Consideration of any additional data/information submitted during the consultation period to further refine the health risk assessment may or may not result in a change to this proposal.

Before making a final re-evaluation decision on phosmet, the PMRA will consider any comments received from the public in response to Proposed Re-evaluation Decision PRVD2017-07, Phosmet. The PMRA will then publish a Re-evaluation Decision that will include the decision, the reasons for it, a summary of comments received on the proposed decision and the PMRA's response to these comments. Once the final decision is made, manufacturers will be required to implement the decision according to the schedule established in the decision document.

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