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

Table of contents

• Special review decisions
• Science evaluation of the aspects of concern summary for both special reviews
• Special review decisions for naled
• Special review under subsection 17(1) of the Pest Control Products Act
• Special review under subsection 17(2) of the Pest Control Products Act
• Next steps
• Other information
• Appendix I - Registered naled products in Canada

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 consultation^{Footnote 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):

• The information received did not result in a change to the toxicology reference values for naled established for the human health risk assessment presented in PSRD2019-02 and PSRD2019-03. However, the dermal reference values for dichlorvos, a transformation product of naled, were updated for the scenarios involving combined exposure to both naled and dichlorvos based on the results of a newly received dermal toxicity study conducted with dichlorvos (Appendix IV of SRD2022-01).
• Additional information resulted in revisions to the occupational risk assessments for all uses, with changes in the final risk outcomes for certain uses (see Science evaluation update and Appendix IV of SRD2022-01 for more details). This resulted in changes to the proposed special review decision (related to occupational risk) as described in PSRD2019-02 and PSRD2019-03:
  • Occupational risks for application on broccoli, Brussels sprouts, cabbage, cauliflower, lettuce, onion (bulb or seed) and strawberry are shown to be acceptable and these uses will be retained. Additional mitigation measures will be implemented, including personal protective equipment, engineering controls and/or limits to amount of product handled per day. Amendments to the product label will reflect these new measures.
  • Occupational risks for groundboom application to tomatoes (field) are shown to be acceptable and this use will be retained. Additional mitigation measures will be implemented, including personal protective equipment and engineering controls. Amendments to the product label will reflect these new measures. Occupational risks are not shown to be acceptable for aerial application to tomatoes. Therefore, aerial application to tomatoes is prohibited and the label will indicate ground application only to tomatoes (field).
  • Occupational risks for application to outdoor ornamentals are shown to be acceptable. Additional mitigation measures will be implemented, including personal protective equipment, engineering controls and limits to amount of product handled per day. Amendments to the product label will reflect these new measures. Application by handheld mistblower will be prohibited and a statement to this effect will be added to the label.
  • Occupational risks for aerial application in livestock pastures, feedlots, pastures (dairy cattle present) for adult mosquitoes, gnats and house fly treatment, are shown to be acceptable. Additional mitigation measures will be implemented, including personal protective equipment, engineering controls and limits to amount of product handled per day. Amendments to the product label will reflect these new measures. Application by Ultra Low Volume (ULV)/mistblower tractor or handheld mistblower will be prohibited and statements to this effect will be added to the label.
  • Occupational risks for aerial application in corrals, adjacent pastures, holding pens (dairy or beef cattle, sheep, horses, hogs present) for mosquitoes and adult house fly treatment are shown to be acceptable. Additional mitigation measures will be implemented, including personal protective equipment, engineering controls and limits to amount of product handled per day. Amendments to the product label will reflect these new measures.
  • Occupational risks are not shown to be acceptable for aerial and groundboom application to rangeland, field areas and pastures for grasshopper treatment; for application in woodlands for mosquito, gnat and housefly treatment; for alfalfa, clover, vetch, peas (processing), beans (dry or field), lima beans, potato, and sugar beets. Therefore, these uses will be cancelled.
  • Occupational risks for postapplication workers are not shown to be acceptable for all greenhouse food and non-food crops (cucumbers, tomatoes, eggplants, peppers, roses and cut flowers) including application by vapour cold pipe treatment and automated fogging equipment; and in and around dairy barns, livestock barns, pig pens, poultry houses, cider mills, and wineries for control of mosquitos, gnats, houseflies, lesser houseflies and fruit flies. Therefore, these uses will be cancelled.

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

• The information received did not result in a change to the dietary assessment presented in PSRD2019-03.

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

• Following consideration of comments and information submitted during the consultation period for PSRD2019-03, the aquatic risk assessment for runoff was revised for naled and dichlorvos. Based on an evaluation of the available information and revised use pattern, the risks associated with the use of naled was found to be acceptable with additional risk mitigations measures including buffer zones and precautionary statements which will be added to the label.

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:

• broccoli, Brussels sprouts, cabbage, cauliflower, lettuce, onion, strawberry
• tomato (ground application)
• outdoor ornamentals
• livestock pastures, feed lots, corrals, holding pens (aerial application for mosquitoes, houseflies or gnats)

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:

• tomatoes (aerial application)
• beans (dry or field), lima beans, peas (processing), alfalfa, clover, vetch, potato, sugar beets
• rangeland, field areas, and pastures (aerial application for grasshopper treatment)
• all greenhouse uses (roses and ornamentals grown for cut flowers, tomatoes, cucumbers, eggplants, peppers)
• in and around dairy barns, livestock barns, pig pens, poultry houses, cider mills, wineries
• woodland

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

• Cancellation of the following uses due to potential risks to human health:
  • beans (dry or field), lima beans, peas (processing), alfalfa, clover, vetch, potato, sugar beets
  • rangeland, field areas, and pastures (aerial application for grasshopper treatment)
  • all greenhouse uses (roses and ornamentals grown for cut flowers, tomatoes, cucumbers, eggplants, peppers)
  • all structural uses including indoor uses (in and around dairy barns, livestock barns, pig pens, poultry houses, cider mills, and wineries), and
  • woodland
• Additional mitigation measures for the remaining uses:
  • Prohibition of use of the following types of application equipment for all crops/sites:
    • ultra-low volume sprayer
    • handheld mistblower/fogger.
  • Prohibition of aerial application for tomato.
  • Additional engineering controls such as:
    • closed mix/load system for all equipment except handheld
    • closed cab when using larger amounts of product per day
  • Additional PPE requirements for all workers who mix, load or apply the end-use product containing naled
  • Limitation on the amount that workers can handle per day for certain uses/applications
• These same risk mitigation measures related to human health (occupational) are required for the special review under subsection 17(2) of the Pest Control Products Act.

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

• Buffer zones to protect aquatic habitats.
• Label amendments include standard environmental precautions regarding toxicity, runoff, not to be used for aquatic pests, minimum spray volume of 10 L and removal of No. 2 fuel oil as a diluent for aerial application.

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 objection^{Footnote 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 amendments^{Table 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