Pest Management Regulatory Agency
03 February 2025
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2025-3E-PDF (PDF version)

Table of Contents

• Background
• Purpose of consultation
• Dietary health assessment
• Proposed MRLs
• International situation and trade implications
• How to get involved
• Appendix I
• References

Background

Regulatory amendments to maximum residue limits (MRLs)Footnote1 are being proposed for lambda-cyhalothrin, as part of the following applications submitted by Syngenta Canada Inc. under submission numbers 2021-5384, 2021-5388 and 2024-6055, by Adama Agricultural Solutions Canada Ltd under submission numbers 2022-1218 and 2022-1219, and by Sharda CropChem Limited under submission number 2024-6098.

Under the authority of the Pest Control Products Act, Health Canada's Pest Management Regulatory Agency (PMRA) is proposing acceptability of the requested applications to re-instate the livestock feed uses to the product labels of Voliam Xpress, Matador 120EC, Warrior Insecticide, Silencer 120EC, Zivata and Labamba, all containing technical grade lambda-cyhalothrin (to control to control various insects) as a late post-emergence application. The specific uses approved in Canada are detailed on these product labels, Pest Control Products Act Registration Numbers 30325, 24984, 26837, 29052, 32427 and 33576 respectively.

The final decision for lambda-cyhalothrin indicated that the re-instatement of the livestock feed uses has value and the human health and environmental risks associated with these uses are acceptable. However, the risks from dietary exposure to residues of lambda-cyhalothrin in or on apples and peaches, when considered with the re-instatement of the livestock feed uses, were not shown to be acceptable. Therefore, MRLs for apples and peaches are proposed for revocation.

Purpose of consultation

The purpose of this Proposed Maximum Residue Limit (PMRL) document is to:

• establish new MRLs on livestock commodities, as a result of the re-instated feed uses; and
• revoke the established lambda-cyhalothrin MRLs on apples and peaches of 0.3 ppm and 0.5 ppm, respectively. After revocation, residues of lambda-cyhalothrin in or on apples and peaches will be regulated under the MRL of 0.01 ppm, currently established for "all food commodities (other than those listed in this item)".

Dietary health assessment

In assessing the risk of a pesticide, Health Canada combines information on pesticide toxicity with information on the degree and duration of dietary exposure to the pesticide residue from food. The risk assessment process involves four distinct steps:

1. Identifying the toxicology hazards posed by the pesticide;
2. Determining the "acceptable dietary level" for Canadians (including all vulnerable populations), which is protective of adverse health effects;
3. Estimating human dietary exposure to the pesticide from all applicable sources (domestic and imported commodities); and
4. Characterizing health risk by comparing the estimated human dietary exposure to the acceptable dietary level.

Before making any decision on pesticide registrations in Canada, Health Canada must determine the quantity of residues that could remain in or on the food when the pesticide is used according to label directions and that such residues will not be a concern to human health (Steps 3 and 4). If estimated human exposure is less than or equal to the acceptable level (developed in Step 2), Health Canada concludes that consuming residues resulting from use according to approved label directions is not a health concern. The results of the dietary risk assessment can be found in Appendix I.

The proposed MRL is then subject to consultation to legally specify it as an MRL. An MRL applies to the identified raw agricultural food commodity as well as to any processed food product that contains it, except for certain instances where different MRLs are specified for the raw agricultural commodity and its processed product(s).

Consultation on the proposed MRL actions is being conducted via this document. Health Canada invites the public to submit written comments on the proposed MRL actions in accordance with the process outlined in the How to get involved section of this document.

To comply with Canada's international trade obligations, consultation on the proposed MRLs is also being conducted internationally by notifying the World Trade Organization, as coordinated by the Canada's Notification Authority and Enquiry Point.

Proposed MRLs

As a result of the revised dietary risk assessments for lambda-cyhalothrin, MRLs are proposed for various animal commodities (Table 1).

Revocation of MRLs

Human health risks were identified for the uses on apples and peaches. Therefore, MRLs for lambda-cyhalothrin on apples and peaches are proposed for revocation. Following the revocation, residues in or on these crops will be regulated under the established MRL of 0.01 ppm for "All food commodities (other than those listedin this item)". Consultation on the revocation of the MRLs for apples and peaches is being conducted via this document.

MRLs established in Canada may be found using the Maximum Residue Limit Database on the Maximum Residue Limits for Pesticides webpage. The database allows users to search for established MRLs, regulated under the Pest Control Products Act, both for pesticides and for food commodities.

International situation and trade implications

Internationally, MRLs are used to facilitate trade of food commodities between countries. Canadian MRLs are established or amended based on a robust scientific risk assessment that demonstrates safety for people in Canada. Table 2 and Table 3 compare the MRLs proposed for lambda-cyhalothrin in Canada with the corresponding tolerances in the United States (U.S.) and international Codex MRLs. The Codex Alimentarius Commission is an international organization under the auspices of the United Nations that develops international food standards, including MRLs.

The U.S. tolerances are listed by pesticide in the Electronic Code of Federal Regulations, 40 CFR Part 180. The term "tolerance" is used in the U.S. as another name for MRLs.

The Codex MRLs are listed by pesticide or commodity on the Codex Alimentarius Pesticide Index webpage.

How to get involved

Health Canada invites the public to submit written comments on the proposed MRL actions up to 75 days from the date of publication of this document (by 16 April 2025). Please forward your comments to Publications. Health Canada will consider all comments received and a science-based approach will be applied in making a final decision on the proposed MRLs. Comments received will be addressed in a response to comments document found in Pesticides and pest management consultations. The established MRLs will be legally in effect as of the date that they are entered into the Maximum Residue Limit Database.

Appendix I

Monitoring data from several sources including grower groups, academia and regulators were submitted to refine the dietary risk assessments. Previously reviewed residue data from field trials conducted on crops from which livestock feed items are derived, as well as processing and livestock feeding studies were also reassessed in the framework of this petition.

Results of the acute dietary risk assessment

Using all the available dietary risk assessment refinements, including the revocation of the uses of lambda-cyhalothrin on apples and peaches, the acute dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 94% of the acute reference dose, and therefore there are no health concerns.

Results of the chronic dietary risk assessment

Using the same refinements as those for the acute dietary risk assessment, the chronic dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 60% of the acceptable daily intake, and therefore there are no health concerns.

Following the evaluation of all listed lambda-cyhalothrin submissions, the MRLs proposed in Table 1 are recommended in order to cover residues of lambda-cyhalothrin in livestock food commodities. Dietary risks from exposure to residues of lambda-cyhalothrin in these animal commodities together with the revocation of the MRLs for apples and peaches were shown to be acceptable for the general population and all subpopulations, including infants, children, adults and seniors. Thus, the foods that contain residues as listed in Table 1 are considered safe to eat.

References

None.