Special review decision SRD2020-02, Special review decision: dichlorvos

Pest Management Regulatory Agency
20 August 2020
ISSN: 2561-6269 (PDF version)
Catalogue number: H113-17/2020-2E-PDF (PDF version)

PDF version (204.5 KB, 12 pages)

Table of Contents

Special review decision

Pursuant to subsection 17(2) of the Pest Control Products Act, Health Canada’s Pest Management Regulatory Agency (PMRA) initiated a special review of all registered pest control products containing dichlorvos, based on the European Union regulatory decisions (2007, 2012) to prohibit all uses of dichlorvos in European Union member countries due to human health and environmental concerns (Canada, 2013).

The aspects of concern identified for the special review are potential carcinogenicity of dichlorvos, potential occupational and residential risks, and potential risk to non-target organisms.

Health Canada evaluated the aspects of concern that prompted the special review in accordance with subsection 18(4) of the Pest Control Products Act. The proposed special review decision was published for consultation in the Re-evaluation Note REV2018-01, Special Review of Dichlorvos and Its Associated End-use Products: Proposed Decision for Consultation(Canada, 2018). Comments and additional information were received during the consultation period. Respondents are listed in Appendix I.

In addition to the consultation on REV2018-01, Health Canada consulted on a proposed re-evaluation decision of dichlorvos in 2017 (PRVD2017-16; Proposed Re-evaluation Decision for Dichlorvos and Its Associated End-use Products; Canada, 2017). Comments and information were received during the consultation of PRVD2017-16.

All comments and information except the comments related to cumulative risk assessment (CRA) received for the proposed special review decision (REV2018-01) are the same as those received for the consultation of the proposed re-evaluation decision (PRVD2017-16).

The final special review decision considered the comments and information received as part of the proposed special review decision. The outcome of the assessment of the aspects of concern, based on the additional information received during the consultation of the REV2018-01 is outlined below:

As the same information (except related to CRA) was received during consultation of the PRVD2017-16 and REV2018-01, details on the updated human health assessment (revised toxicology, occupational and residential risk assessments) and responses to comments (except the response related to CRA) are in RVD2020-08. Response to comments related to CRA is in Appendix II. In addition, as the label amendments related to the aspects of concern are included in RVD2020-08 (Canada, 2020), they are not listed in detail in this decision document. However, a summary of the required label amendments for the special review is included in Appendix III.

Following an evaluation of the aspects of concern, Health Canada has determined that continued registration of some products containing dichlorvos is considered to be acceptable with the revised label.

All pest control products containing dichlorvos that are registered in Canada are subject to this special review decision. Currently registered products containing dichlorvos are listed in Appendix IV.

This document presents the final regulatory decision for the special review of dichlorvos. 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 this decision document. 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 this decision document to transition to using the newly amended labels, which will be available on the Public Registry. Registrants of the products containing dichlorvos will be informed of the specific requirements affecting their product registration(s) and of the regulatory options available to them.

Products that are cancelled will be phased out following the implementation timeline outlined below.

Other Information

Any person may file a notice of objectionFootnote 1 regarding this decision on dichlorvos within 60 days from the date of publication of this Special Review Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of Canada.ca (Request a Reconsideration of Decision) or contact the PMRA’s Pest Management Information Service.

Appendix I List of respondents to REV2018-01

List of respondents’ affiliations in terms of comments submitted in response to REV2018-01
Category Respondent Comments
Non-Governmental Organisation Ecojustice on behalf of the Canadian Association of Physicians for the Environment, the David Suzuki Foundation, Environmental Defence and Équiterre

Refer Appendix II of this document. Response to comments related to CRA.

Refer RVD2020-08, Appendix III for the response to other comments related to human health.

Registrant AMVAC Chemical Corporation
Grower group Canadian Horticulture Council (CHC) on behalf of Canada’s greenhouse vegetable growers

Appendix II Comments and responses

The PMRA received comments from stakeholders in response to Re-evaluation Note REV2018-01, Special Review of Dichlorvos and Its Associated End-use Products: Proposed Decision for Consultation (Canada, 2018). Comments (related to human health aspects of concern) received as part of the proposed special review decision were the same as those received during the consultation of the proposed re-evaluation decision (PRVD2017-16), except the comments related to organophosphates (OP) cumulative risk assessment (CRA). Response to the comment on CRA is included below. As other comments received as part of the REV2018-01 are the same as the PRVD2017-16, the responses are included in the RVD2020-08 (refer to Appendix III of RVD2020-08 for the PMRA’s responses).

1. Comments related to cumulative risk assessment

The commenter indicated the need for conducting a cumulative assessment as part of the REV2018-01, to comply with subsection 19(2)b(i) of the Pest Control Product’s Act. The comment also specified that the United States Environmental Protection Agency (USEPA) completed a preliminary cumulative effects analysis for organophosphates including dichlorvos in 2002, with an update in 2006. In addition, the commenter expressed the desire to know when the PMRA intends to complete the organophosphate re-evaluations and special reviews, the status of the PMRA’s cumulative effects methodology for organophosphates (whether it is completed and will it be consulted with the public), and the timeline for the cumulative assessment of health risks of organophosphates.

PMRA response

Health Canada’s PMRA agrees that the cumulative assessment of pesticides is an important step in evaluating health risks. The PMRA continues to engage with the international science community, including other Health Canada programs, as well as international regulatory partners such as the EPA, and the European Food Safety Authority, on how to best assess cumulative effects of pesticides.

Following consultation on the proposed cumulative assessment approach (PRO2017-01), the PMRA published its framework for cumulative assessments in the Science Policy Note SPN2018-02 Cumulative Health Risk Assessment Framework (April 2018). This document describes the framework and methodology that the PMRA will use for assessing the cumulative health effects of pesticides that have a common mechanism of toxicity, which will also apply to the cumulative risk assessment (CRA) for organophosphate (OP) pesticides.

The PMRA acknowledges that the cumulative assessment for OP pesticides has been completed by the USEPA, as have their re-evaluations of the individual pesticides in the OP group. The USEPA used the Relative Potency Factor method to assess the cumulative risk of OP pesticides, which is described in SPN2018-02. This method is heavily reliant on the quality and availability of appropriate toxicology and exposure data and requires the calculation of a relative potency factor for each individual chemical. This further highlights the importance that the assessment of all of the OP pesticides currently under re-evaluation be complete before initiating the CRA.

It should be noted that the USEPA indicated no further mitigation was required from cumulative exposure to OPs, as the mitigation put in place for each individual OP pesticide, based on the individual re-evaluations, was sufficient.

In Canada, of the 27 OP pesticides that were originally registered at the time of re-evaluation initiation by the PMRA, more than half are no longer registered. Significant mitigation measures were required for the OPs that were granted continued registration following re-evaluation. Furthermore, extensive mitigation measures are proposed for the remaining OPs for which re-evaluations are to be completed.

Once the final decisions for the remaining individual OPs have been published, the CRA for the OP cluster will be initiated, and will include all of the re-evaluated OP pesticides, OP active ingredients on imported commodities, and any new OP pesticides and uses not captured in the re-evaluations. As indicated above, it is essential that the toxicology and exposure assessments of the individual pesticides be up-to-date prior to undertaking the CRA. This ensures that current information is taken into account in the assessment. In addition, it is important to complete the risk assessments for each of these pesticides in order to mitigate individual chemical risks prior to undertaking a CRA. Failing to mitigate individual chemical risks prior to performing a CRA would unnecessarily complicate a CRA, as well as potentially obscure any drivers of cumulative risk.

Once the initiation of the cumulative assessment for the OPs has been announced, and any requested data has been received, the PMRA will establish a targeted timeline for the consultation on the proposed cumulative assessment and this information will be included in the PMRA’s published re-evaluation and special review workplan. In the meantime, the PMRA will continue to monitor the progress and results of other cumulative risk assessments for OP pesticides from other international regulators and will take appropriate action, if needed.

2. Other comments related to the health risk assessments

PMRA response

Please see RVD2020-08, Appendix III for the PMRA’s response.

Appendix III Summary of the required label amendments (risk reduction measures) related to the aspects of concern

Human health

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

Cancellation of use:

Label amendments:

Environment

The following precautionary label statement is required:

Uses not supported by manufacturers for re-evaluation and will be removed from all product labels:

Appendix IV Registered pest control products containing dichlorvos as of 5 March 2020

Table 1 Registered pest control products containing dichlorvos as of 5 March 2020
Registration Number Marketing Class Registrant Product Name Formulation Type Guarantee
19723 Technical Amvac Chemical Corporation Dichlorvos (DDVP) Technique Liquid 97.7%
11819 Commercial Gardex Chemicals Ltd.> Gardex Vapona Insecticide Industrial Fogging Solution Emulsifiable
Concentrate
4.65%
16476 Commercial Gardex Chemicals Ltd. Gardex Vapona-20 ULV Concentrate Emulsifiable
Concentrate
20%
19680 Commercial Premier Tech Brighton Ltd. Pro Professional DDVP-20 Ultra-Low Volume Insecticide Solution 20%
21222 Commercial
  • Aberdeen Road Company d/b/a
  • HERCON ENVIRONMENTAL
Vaportape II
Insecticidal Strips
Slow-Release
Generator
10%
21824 Commercial Plus (9021-7993 Quebec Inc.) DICHLORVOS PLUS #1 READY TO USE INSECTICID Solution 1.8%
23915 Commercial LOVELAND PRODUCTS CANADA INC. DDVP 20% Insecticide Emulsifiable
Concentrate
20%
22027 Domestic Scotts Canada Ltd. Ortho® Home Defense Max No-Pest Insecticide Strip Slow-Release
Generator
19.2%

References

Published Information

PMRA# 2405939
Reference: Canada, 2013. Re-evaluation Note: Special Review Initiation of 23 Active Ingredients. REV2013-06.
PMRA# 2767433
Reference: Canada, 2017. Proposed Re-evaluation Decision PRVD2017-16, Dichlorvos and Its Associated End-use Products
PMRA# 2906053
Reference: Canada, 2018. Re-evaluation Note REV2018-01, Special Review of Dichlorvos and Its Associated End-use Products: Proposed Decision for Consultation
PMRA# 3090961
Reference: Canada, 2020. Re-evaluation Decision: Dichlorvos. RVD2020-08.

Footnotes

Footnote 1

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

Return to footnote 1 referrer

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: