Re-evaluation Note REV2021-04, Cancellation of remaining chlorpyrifos registrations under paragraph 20(1)(a) of the Pest Control Products Act

Pest Management Regulatory Agency
21 December 2021
ISSN: 1925-0649 (PDF version)
Catalogue number: H113-5/2021-4E-PDF (PDF version)

This decision replaces Re-evaluation Note (REV2021-02)Footnote 1, which informed the public that the registrations of the remaining pest control products containing chlorpyrifos were being cancelled due to failure to fulfill the mandatory data requirements under the Pest Control Products Act. Re-evaluation Note REV2021-02 of 13 May 2021 did not contain reasons for the phase-out period selected by Health Canada. This decision (REV2021-04) immediately cancels the registrations of the remaining chlorpyrifos products subject to the mandatory data call-in under the Pest Control Products Act and provides reasons for the phase-out period.

Background

The re-evaluation for chlorpyrifos proceeded in several phases: the first phases in 2000, 2003 and 2007 assessed the health risks and some environmental risks, with the full environmental assessment completed in 2020. The final phase of re-evaluation was intended to update the current health risk assessment. The chlorpyrifos re-evaluation decision related to environmental risk (PRVD2019-05Footnote 2 and RVD2020-14Footnote 3) resulted in the cancellation of a number of registrations of pest control products. Health Canada also identified additional data needed for the re-evaluation to update the current health risk assessment for the remaining registered products.

On 10 February 2021, Health Canada sent a notice to the two registrants of the remaining products containing chlorpyrifos requiring various data in order to complete the update to the health risk assessment. By that time, only products from these two registrants remained subject to the ongoing re-evaluation with respect to the health risk assessment because all other products containing chlorpyrifos were already in the course of being phased-out following prior cancellation decisions or following voluntary discontinuations. See Appendix I for the complete list of all products containing chlorpyrifos subject to a phase-out period.

As the registrants of chlorpyrifos products were unable to fulfill these data requirements, Health Canada cancelled the registrations of the remaining pest control products containing chlorpyrifos, according to the phase-out timeline below. This timeline was the same as that which was imposed on product registrations cancelled as a result of the environmental risk assessment (RVD2020-14), with the exception of uses on canola and garlic, which were originally extended until 2024 in RVD2020-14, but were then aligned with the same phase-out timeframe as all of the other cancelled uses.

Phase-out Timeline:

On 13 May 2021, Health Canada published a Re-evaluation Note (REV2021-02) informing the public that the registrations of the remaining pest control products containing chlorpyrifos were being cancelled with a phase-out period due to failure to fulfill the mandatory data requirements. In the Re-evaluation Note, Health Canada did not explain its reasons for applying the phase-out period.

This decision (REV2021-04) confirms the cancellation of the registrations of the remaining products/uses of chlorpyrifos and sets out Health Canada's determination that, in accordance with the Pest Control Products Act and Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review,Footnote 4the risks are not imminent and serious during the phase-out period.

Final determination with respect to chlorpyrifos

The remaining products containing chlorpyrifos are now cancelled, effective as the date of this publication, in accordance with Information Note: Update on implementation of post-market decisions published 21 December 2021. No manufacturing within Canada or importation into Canada is allowed. The remaining products whose registrations are immediately cancelled are:

Paragraph 21(5)(a) of the Pest Control Products Act permits Health Canada to allow existing stocks of cancelled products in Canada to remain authorized for continued possession, handling, storage, distribution and use over a phase-out period, subject to any conditions that are necessary for carrying out the purposes of the Pest Control Products Act.

The following conditions apply to the products subject to this decision:

This allows existing stocks of chlorpyrifos products in Canada to be exhausted in an orderly manner, to minimize potential risks associated with disposing of existing product all at once, and to minimize potential confusion for the users.

i) Overview of Policy on cancellations and amendments following re-evaluation and special review

The Policy on Cancellations and Amendments Following Re-evaluation and Special Review, provides a framework for the cancellation of pesticide products or amendments to pesticide product uses, labels, or other conditions of registration following a re-evaluation or special review decision, or the failure to meet mandatory data requirements. The policy also outlines the process, the associated timelines as well as how the timelines for cancellation or amendment of pesticide products are established.

This policy is intended to enhance transparency of the process and associated timelines when regulatory action is required to remove products from the market, change approved uses, or introduce amendments to labels. It is also intended to facilitate efficient and effective implementation of re-evaluation and special review decisions, including by ensuring an orderly transition in order to minimize the potential for non-compliance. Standardized timelines aim to clarify expectations, obligations and communications around the implementation of regulatory decisions.

The primary consideration for the implementation timelines for cancellation and amendment is based on the risks to human health or the environment, in other words, whether risks are considered imminent and serious, taking into account the following factors:

In cases where no imminent and serious risks to human health or the environment are identified, the implementation timelines outlined in DIR2018-01Footnote 5 are applied to products or uses subject to the re-evaluation or special review decision.

Implementation is expedited when risks of concern are considered to be imminent and serious. Such circumstances involve a significant likelihood of serious effects occurring, for example, adverse effects reported in incident reports submitted to Health Canada involving death or serious bodily harm. In these circumstances, other appropriate measures may also be required, such as requiring the registrant to over-sticker labels on existing stocks with risk mitigation statements, or issuing an immediate product recall in accordance with the Pest Control Products Act (p. 21(5)(b)).

ii) No imminent and serious risks during ongoing phase-out

Health Canada has determined that the risks for current chlorpyrifos uses are not imminent and serious during the period of the phase-out described above, taking into account the following considerations:

iii) International status and Canadian comparison

European Union

In 2020, the European Commission (EC) prohibited all uses of chlorpyrifos based on human health concerns resulting from data uncertainties. Following a preliminary analysis of the 2020 EC decision concerning the non-renewal of plant protection products containing chlorpyrifos, Health Canada identified the following aspects of concern:

The basis of the European decision was articulated in the 31 July 2019 statement by the European Food Safety Authority (EFSAFootnote 13), which noted that no toxicology reference values were established and a risk assessment was not conducted. Thus, the EC decision was based on potential hazard (any possible adverse or toxic effect), rather than risk (likelihood of an adverse effect based on the amount of exposure). It is important to note that a hazard classification is not a health risk assessment. A hazard describes any possible adverse or toxic effect that may be attributed to a substance at various dose or exposure levels, whereas an assessment of risk focusses on the likelihood of an adverse effect occurring with a given amount of exposure. Thus, the levels of human exposure, which determine the actual risk, were not taken into account in the EC decision. In Canada, pesticides undergo a health and environmental risk assessment to establish the level of exposure to Canadians and the environment that does not result in harmful effects. The level of acceptable exposure that is established by Health Canada and used for health risk assessment also incorporates additional safety factors, providing a further degree of protection.

On 10 February 2021, a notice was issued by Health Canada (Reference No. 2019-3275) that a new special review of chlorpyrifos relating to a 2020 EC decision to cancel all uses would not be initiated under subsection 17(2) of the Pest Control Products Act. This was because the identified aspects of concern would be assessed with the ongoing re-evaluation of chlorpyrifos at that time, specifically in relation to updating the human health risk assessment, as per subsection 17(7) of the Pest Control Products Act. Because the remaining product registrations were cancelled in the now superseded May 2021 decision, and that has not changed with this new decision, a health risk assessment will not be conducted. However, for the reasons described above, Health Canada has determined that there are no imminent and serious health risks that would warrant a shorter phase-out period.

Australia

As noted previously, the most recent final risk-based decision, which took into consideration the additional health information, was published in 2019 by the Australian Pesticide and Veterinary Medicine Authority (APVMA). Health Canada's human health reference values continue to be either aligned with those of APVMA for sensitive subpopulations including women of child-bearing age, or more conservative (in other words, more protective) in the case of infants and children.

United States

In the United States, the USEPA registration review of chlorpyrifos is ongoing, and a final decision regarding the registration status of chlorpyrifos is not scheduled until 2022. A December 2020 proposed interim decision proposed retaining 11 critical uses (alfalfa, apple, cherries (tart), asparagus, citrus, cotton, peach, soybean, strawberry, sugar beet, wheat), which were found to have acceptable health risk with mitigation measures. However, a recent (August 2021) USEPA Final RuleFootnote 14 made in response to an order from the United States Court of Appeals for the Ninth Circuit has since resulted in the phase-out of all food uses of chlorpyrifos, including revocation of all Maximum Residue Limits, (referred to as tolerances in the United States). The decision of the United States to revoke all tolerances (in other words, MRLs) acknowledged that there were no risks of concern around chlorpyrifos residues on food based on their scientific assessment. However, the American tolerances were revoked based on different factors. First, there were concerns involving drinking water in the United States that are not applicable to the Canadian situation, given how rarely chlorpyrifos has been detected in Canadian drinking water, and when detected, falls below the level of concern. Second, a United States court order required an all or nothing conclusion on acceptable risk from the combined exposure to chlorpyrifos residues from drinking water, plus all current uses (food, commercial turf (for example, golf courses), etc.). Conversely, Canada has cancelled all uses and is applying the above-noted schedule, and overall the Canadian use pattern is smaller and more restrictive than that of the United States, having comparatively lower application rates and shorter seasonal uses.

Thus, it is important to keep in mind that this action in the United States is separate and distinct from the USEPA registration review process. Uses in non-food settings remain registered in the United States until completion of the re-evaluation.

Canada

As noted in Section (ii), Health Canada's current human health reference values (acceptable levels of exposure) continue to be either aligned with those of the APVMA and USEPA for sensitive subpopulations including women of child-bearing age, or more conservative (in other words, more protective) in the case of infants and children.

Thus, given dietary risks were acceptable in Health Canada's original assessment using health reference values that are either aligned with or more conservative than the more recently updated human health reference values of other jurisdictions, Health Canada's assessment would still be protective of the Canadian population, including infants and children.

Conclusion

As noted above, Health Canada has implemented several risk reduction measures for chlorpyrifos over the years. In 2000, Health Canada stopped allowing almostFootnote 15 all uses by homeownersFootnote 16 and updated chlorpyrifos labels to reflect this. In addition, Health Canada implemented mitigation measures in 2007 (REV2007-01, Update on the Re-evaluation of Chlorpyrifos) to further protect human health and the environment, following an assessment on agricultural and forestry uses. In December 2020, Health Canada published a re-evaluation decision (RVD2020-14, Chlorpyrifos and Its Associated End-use Products (Environment)) based on an updated environmental risk assessment (PRVD2019-05, Chlorpyrifos and Its Associated End-use Products: Updated Environmental Risk Assessment). In this decision, Health Canada cancelled almost all agricultural uses due to environmental risks of concern, while a few uses were acceptable from the environmental perspective. In this current decision (REV2021-04), all remaining registrations of pest control products containing chlorpyrifos are cancelled immediately due to failure to fulfill the mandatory data requirements to update the human health risk assessment for the final phase of the re-evaluation. Health Canada has determined that the current chlorpyrifos uses will not pose imminent and serious risks during the period of the phase-out described under the section entitled: Final Determination with Respect to Chlorpyrifos, taking into account the considerations outlined under section (ii).

Appendix I – Products containing chlorpyrifos subject to a phase-out period

Table 1 Products containing chlorpyrifos subject to a phase-out periodFootnote 17
Registration number Product name Registrant name StatusTable 1 Footnote *
14879 Lorsban 4E Insecticide Corteva Agriscience Canada Company Phase-Out Ending 2023-12-09
16458 Lorsban 15G Insecticide Corteva Agriscience Canada Company Phase-Out Ending 2023-12-09
19656 Dursban FM Insecticidal Chemical Corteva Agriscience Canada Company Phase-Out Ending 2023-12-09
20320 Dursban HF Insecticidal Concentrate Corteva Agriscience Canada Company Phase-Out Ending 2023-12-09
20407 Dursban W Insecticidal Concentrate Corteva Agriscience Canada Company Phase-Out Ending 2023-12-09
20944 Lorsban 50W Insecticide Corteva Agriscience Canada Company Phase-Out Ending 2023-12-09
21997 Dursban Water Soluble Insecticide Corteva Agriscience Canada Company Phase-Out Ending 2023-12-09
23621 Pyrinex Technical Chlorpyrifos Insecticide Adama Agricultural Solutions Canada Ltd. Phase-Out Ending 2023-12-10
23704 Pyrate 480 EC Insecticide Adama Agricultural Solutions Canada Ltd. Phase-Out Ending 2023-12-10
23705 Pyrinex 480EC For Food Crops Adama Agricultural Solutions Canada Ltd. Phase-Out Ending 2023-12-10
24648 Pyrifos 15G Insecticide Loveland Products Canada Inc. Phase-Out Ending 2023-12-10
25823 Chlorpyrifos Technical FMC of Canada Limited Phase-Out Ending 2022-12-31
25831 Nufos 4E Insecticide FMC of Canada Limited Phase-Out Ending 2023-12-10
27479 Citadel 480EC Insecticide Interprovincial Cooperative Limited Phase-Out Ending 2022-12-10
29650 Lorsban NT Insecticide Corteva Agriscience Canada Company Phase-Out Ending 2023-12-09
29984 Warhawk 480 EC Insecticide Loveland Products, Inc. Phase-Out Ending 2023-12-10
30985 Mpower Krypton NewAgco Inc. Phase-Out Ending 2023-12-10
31417 Chlorpyrifos Agrogill Technical Grade Active Ingredient Agrogill Chemicals Pty Ltd Phase-Out Ending 2023-12-10
32694 Sharda Chlorpyrifos Technical Insecticide Sharda Cropchem Limited Phase-Out Ending 2023-12-10
32768 Sharphos Insecticide Sharda Cropchem Limited Phase-Out Ending 2023-12-10
33113 Pyrinex 450 LV EC Adama Agricultural Solutions Canada Ltd. Phase-Out Ending 2023-12-10
33295 Newagco Chlorpyrifos Technical NewAgco Inc. Phase-Out Ending 2023-12-10
33356 Mpower Chlorpyrifos Insecticide NewAgco Inc. Phase-Out Ending 2023-12-10
Table 1 Footnote *

For details, consult the Pesticide Product Information Database

Table 1 Return to footnote * referrer

Footnote 1

REV2021-02, Update on the re-evaluation of chlorpyrifos

Return to footnote 1 referrer

Footnote 2

PRVD2019-05, Chlorpyrifos and Its Associated End-use Products: Updated Environmental Risk Assessment

Return to footnote 2 referrer

Footnote 3

RVD2020-14, Chlorpyrifos and Its Associated End-use Products (Environment)

Return to footnote 3 referrer

Footnote 4

Regulatory Directive 2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review

Return to footnote 4 referrer

Footnote 5

DIR2018-01, Policy on cancellation and amendments following re-evaluation and special review.

Return to footnote 5 referrer

Footnote 6

PACR2003-03, Phase 2 of the Re-evaluation of Chlorpyrifos

Return to footnote 6 referrer

Footnote 7

Chlorpyrifos Proposed Interim Registration Review Decision Case Number 0100 December 2020

Return to footnote 7 referrer

Footnote 8

The maximum detection of 4 µg chlorpyrifos/L from Canadian monitoring data was from one sample in Québec, in 2005. All other samples were below the drinking water level of concern (DWLOC).

Return to footnote 8 referrer

Footnote 9

Further characterization of risks concentrated on a 2000-2016 subset of 15,080 samples from the available data.

Return to footnote 9 referrer

Footnote 10

Withdrawal of Select Guidelines for Canadian Drinking Water Quality

Return to footnote 10 referrer

Footnote 11

APVMA Reconsideration of chlorpyrifos: Residential exposure and public space use exposure assessment and risk characterisation update. https://apvma.gov.au/sites/default/files/publication/50121-chlorpyrifos_2019_residential_exposure_assessment_and_risk_characterisation_report.pdf

Return to footnote 11 referrer

Footnote 12

July 31, 2019 statement by the European Food Safety Authority (EFSA): https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2019.5809

Return to footnote 12 referrer

Footnote 13

July 31, 2019 statement by the European Food Safety Authority (EFSA): https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2019.5809

Return to footnote 13 referrer

Footnote 14

USEPA, Chlorpyrifos Tolerance Final Rule Docket

Return to footnote 14 referrer

Footnote 15

Containerized low concentration ant baits/bait stations were discontinued in 2017

Return to footnote 15 referrer

Footnote 16

Re-evaluation Note REV2000-05 Chlorpyrifos, 28 September 2000

Return to footnote 16 referrer

Footnote 17

Source: Pesticide Product Information Database [https://pesticide-registry.canada.ca/en/index.html]

Return to footnote 17 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: