Special Review Decision SRD2022-01, Special Review Decisions: Naled

Pest Management Regulatory Agency
12 January 2022
ISSN: 2561-6269 (PDF version)
Catalogue number: H113-17/2022-1E-PDF (PDF version)

Summary

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 Special Review Decision SRD2022-01, Special Review Decisions: Naled please contact our publications office.

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

Table of contents

Special review decisions

Naled (1,2-dibromo-2,2-dichloroethyl dimethyl phosphate) is an organophosphate pesticide used for the control of insects in a wide variety of use areas, including agricultural (food and feed) crops, outdoor ornamentals, greenhouse food crops and ornamentals, in/around structural sites, woodlands, and livestock pastures. Currently registered pest control products containing naled are listed in Appendix I.

Pursuant to subsection 17(1) of the Pest Control Products Act, Health Canada’s Pest Management Regulatory Agency (PMRA) initiated a special review of naled based on the toxicology information submitted under section 12 of the Pest Control Products Act, following the re-evaluation of naled. The aspect of concern for this special review under subsection 17(1) of the Pest Control Products Act is relevant to human health (potential occupational risks).

Health Canada also initiated a special review of naled pursuant to subsection 17(2) of the Pest Control Products Act, based on the prohibition of all uses of naled in the European Union for human health and environmental concerns. The aspects of concern identified for the special review under subsection 17(2) of the Pest Control Products Act are potential occupational and dietary risks, and, potential risk to aquatic and terrestrial organisms.

Health Canada evaluated the aspects of concern that prompted the above two special reviews in accordance with subsection 18(4) of the Pest Control Products Act. The proposed special review decisions were published for consultationFootnote 1 in the Proposed Special Review Decisions PSRD2019-02, Special Review of Naled and Its Associated End-use Product under subsection 17(1) of Pest Control Products Act and PSRD2019-03, Special Review of Naled and Its Associated End use Product under subsection 17(2) of Pest Control Products Act.

The final decision for the two special reviews of naled pursuant to subsection 17(1) and 17(2) of the Pest Control Products Act have been combined into one document because the aspect of concern regarding potential occupational risks and the associated risks identified are the same in both special reviews.

All pest control products containing naled that are registered in Canada are subject to the special review decisions. Special Review Decision SRD2022-01, Special Review Decisions: Naled presents the final regulatory decision for these two special reviews of naled.

Science evaluation of the aspects of concern summary for both special reviews

Comments and additional information were received during the consultation period of both special reviews, see Appendix II of SRD2022-01 for a list of commenters. Comments are summarized in Appendix III of SRD2022-01 with the responses from Health Canada.

The final special review decision considered the comments and information received during the consultation of PSRD2019-02 and PSRD2019-03. The outcome of the revised assessment of the aspects of concern based on additional information received is outlined below:

Potential occupational risks (special reviews under subsection 17(1) and 17(2) of Pest Control Products Act):

Potential dietary risk (special review under subsection 17(2) of Pest Control Products Act):

Potential risk to aquatic and terrestrial organisms (special review under subsection 17(2) of Pest Control Products Act):

Special review decisions for naled

Health Canada has evaluated the aspects of concern, under subsection 17(1) and subsection 17(2) of the Pest Control Products Act, that prompted the special reviews of pest control products containing naled in accordance with subsection 18(4) of the Pest Control Products Act. Health Canada’s Pest Management Regulatory Agency, under the authority of the Pest Control Products Act, has determined that continued registration of certain uses are acceptable with additional mitigation measures (Appendix VI of SRD2022-01). On this basis, Health Canada is amending the current registrations of naled products for sale and use in Canada to implement these risk mitigation measures, pursuant to subsection 21(2) of the Pest Control Product Act.

The assessments of the aspects of concern from both special reviews indicated that the risks to human health and the environment for the following uses of naled are considered to be acceptable. The following uses are to be retained with the implementation of additional mitigation measures, to be shown on the product label:

The assessments indicated that the risk to human health (occupational) for the following uses of naled is not considered to be acceptable, and these uses are to be cancelled:

Special review under subsection 17(1) of the Pest Control Products Act

Evaluation of available scientific information related to occupational risk found that the potential risk to human health is considered to be acceptable with additional risk mitigation measures. Therefore, continued registration of products containing naled is acceptable with the following mitigation measures (Appendix VI of SRD2022-01):

Human Health

Special review under subsection 17(2) of the Pest Control Products Act

Evaluation of available scientific information related to the aspect of concern for dietary risk indicated that under the current conditions of use, the dietary risk (food and drinking water) is considered to be acceptable. No additional mitigation measures are required.

Evaluation of available scientific information related to the aspects of concern for occupational risk indicated that the risks to human health are considered to be acceptable with the implementation of the same risk mitigation measures (related to human health) set out in the previous section in relation to the special review under subsection 17(1) of the Pest Control Products Act.

Evaluation of available scientific information related to the environmental aspects of concern indicated that the risks to aquatic and terrestrial species are considered to be acceptable with the implementation of the following additional risk mitigation measures:

Environment

Based on the above, continued registration of products containing naled is acceptable with additional mitigation measures (Appendix VI of SRD2022-01).

Next steps

To comply with these decisions, the required label amendments (Appendix VI of SRD2022-01) must be implemented no later than 24 months after the publication date of SRD2022-01. Accordingly, both registrants and retailers will have up to 24 months from the date of SRD2022-01 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 SRD2022-01 to transition to using the newly amended labels, which will be available on the Public Registry.

As noted in PSRD2019-02, Health Canada will be initiating a cumulative risk assessment for the organophosphate class of chemicals upon completion of the re-evaluation of the individual chemicals in this group. These decisions in the current document for the naled special reviews represent the last of the re-evaluations/special reviews of the organophosphates in this re-evaluation cycle, and as such the organophosphate cumulative risk assessment will be initiated shortly, with a formal announcement to follow.

Other information

Any person may file a notice of objectionFootnote 2 regarding these decisions on naled within 60 days from the date of publication of SRD2022-01. 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.

The relevant confidential test data on which the decisions are based (as referenced in PSRD2019-02, PSRD2019-03 and SRD2022-01) are available for public inspection, upon application, in the PMRA’s Reading Room. For more information, please contact the PMRA’s Pest Management Information Service.

Appendix I Registered naled products in Canada

Table 1 Registered naled products in Canada requiring label amendmentsTable 1 Footnote 1
Registration number Marketing
class
Registrant Product name Formulation type Guarantee
23202 Technical AMVAC Chemical Corporation AMVAC Naled Technical Solution 94.5%
7442 Commercial Loveland Products Canada Inc. Dibrom Insecticide Emulsifiable concentrate 900 g/L
Table 1 Footnote 1

As of 2 June 2021, excluding discontinued products or products with a submission for discontinuation.

Table 1 Return to footnote 1 referrer

Footnote 1

“Consultation statement” as required by subsection 28(2) of the Pest Control Products Act.

Return to footnote 1 referrer

Footnote 2

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

Return to footnote 2 referrer

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