Special Review Decision SRD2021-03, Special Review Decision: Clothianidin Risk to Aquatic Invertebrates
Pest Management Regulatory Agency
31 March 2021
ISSN: 2561-6269 (PDF version)
Catalogue number: H113-17/2021-3E-PDF (PDF version)
To obtain a full copy of Special Review Decision SRD2021-03, Special Review Decision: Clothianidin Risk to Aquatic Invertebrates please contact our publications office.
Health Canada’s Pest Management Regulatory Agency will host a webinar to provide an overview of the decisions for clothianidin and thiamethoxam. For more information and to register, select the following link: Health Canada webinar.
Should you require further information please contact the Pest Management Information Service.
Table of contents
- Special review decision
- Outcome of science evaluation
- Regulatory decision for clothianidin
- Risk mitigation measures to protect aquatic invertebrates
- Next steps
- Other information
- Appendix I Registered products containing clothianidin in Canada that are subject to this special review decision
- Appendix II Registered commercial class uses of clothianidin in Canada as of 31 July 2020 that are subject to this special review
Special review decision
Pursuant to subsection 17(1) of the Pest Control Products Act, Health Canada’s Pest Management Regulatory Agency (PMRA) conducted a special review of all agricultural and turf uses for registered pest control products containing clothianidin. The decision to conduct the special review was based on a preliminary analysis of available information on the concentration and frequency of detections of clothianidin in the aquatic environment. The aspect of concern for this review is to assess potential risk to aquatic invertebrates exposed to clothianidin applied as a seed, foliar or soil treatment.
Health Canada evaluated the aspect 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 Proposed Special Review Decision (PSRD2018-01), Special Review of Clothianidin Risk to Aquatic Invertebrates: Proposed Decision for Consultation.Footnote 1 Since the publication of PSRD2018-01 on 15 August 2018, a significant number of comments were received during the consultation period. In addition, extensive information obtained from published literature, as well as data received from registrants and environmental monitoring networksFootnote 2 was also considered.
In addition, during the consultation period, Health Canada issued a final re-evaluation decision examining the effects of clothianidin on pollinators Re-evaluation Decision RVD2019-05, Clothianidin and Its Associated End-use Products: Pollinator Re-evaluation. Final Decision. This special review decision takes into consideration the additional mitigation measures put in place as a result of the pollinator re-evaluation. Health Canada has completed the special review for clothianidin, and this final special review decision has resulted in changes to the proposed regulatory decision as described in PSRD2018-01.
A reference list of information used as the basis for the proposed special review decision is included in PSRD2018-01. Further information used in the special review decision is listed in Appendix IX of Special Review Decision: Clothianidin Risk to Aquatic Invertebrates (SRD2021-03). Therefore, the complete reference list of all information used in this final special review decision includes both the information set out in the list of references of the PSRD2018-01 and the information set out in Appendix IX of SRD2021-03.
This document presents the final regulatory decisionFootnote 3 for the special review of clothianidin, including the required risk mitigation measures to protect aquatic invertebrates. All pest control products containing clothianidin that are registered in Canada for agricultural and turf uses are subject to this special review decision (see Appendix I). Appendix II lists all of the registered uses of Commercial Class end-use products containing clothianidin that were subject to this special review, taking into consideration the required use restrictions identified in RVD2019-05. Appendix III of SRD2021-03 summarizes the comments received during the consultation period and provides Health Canada’s responses to these comments. All of the data that were used as the basis for the proposed special review decision are published in PSRD2018-01. Additional data used in the final special review decision, including data received during the consultation period, are listed in Appendix IV of SRD2021-03 for toxicity information and in Appendix VII of SRD2021-03 for monitoring information.
Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing clothianidin is acceptable with additional risk mitigation measures (that is, with changes to the conditions of registration). An evaluation of available scientific information found that uses of clothianidin products meet current standards for protection of the environment when used according to revised label directions, which include mitigation measures. Label amendments, as summarized below and listed in Appendix VIII of SRD2021-03, are required.
Outcome of science evaluation
The environmental risk assessment took into consideration revisions to clothianidin uses as outlined in RVD2019-05, scientific comments received on study interpretations during consultation of PSRD2018-01, newly published relevant toxicity data and additional water monitoring data. Based on these data it was determined that the risks to aquatic invertebrates resulting from chronic exposure following application of clothianidin under certain currently registered conditions are acceptable. For uses where the risks were not shown to be acceptable, mitigation measures are required to minimize exposure to aquatic invertebrates which include changes to the use pattern or cancellation in cases when the mitigation options were not considered viable. In addition to the prescribed mitigation measures, label amendments including the addition of best management practices and label statements informing users of the toxicity to aquatic organisms are required.
Regulatory decision for clothianidin
Health Canada has completed the special review of clothianidin’s risk to aquatic invertebrates. Following an evaluation of the aspect of concern, under the authority of the Pest Control Products Act, Health Canada has determined that, with additional risk mitigation measures, continued registration of products containing clothianidin is acceptable. An evaluation of available scientific information found that some uses of clothianidin products meet current standards for protection of aquatic invertebrate communities when used according to the revised conditions of registration, which include required amendments to label directions. Label amendments, as summarized below and listed in Appendix VIII of SRD2021-03, are required for all end-use products. Certain uses of clothianidin are cancelled as risks to aquatic invertebrates were not shown to be acceptable.
Risk mitigation measures to protect aquatic invertebrates
Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law. The required amendments, including any revised/updated label statements and/or mitigation measures as a result of this special review decision, are summarized below. Refer to Appendix VIII of SRD2021-03 (Label Amendments).
In order to protect aquatic invertebrate communities, Health Canada is cancelling the following uses of clothianidin:
- In-furrow application on potato.
- Seed treatment for field sown leafy vegetables and bunching onion. Planting rates for these crops exceed the maximum allowable application rate of 100 g a.i./ha.
Health Canada is changing the conditions of use of clothianidin for the following crops:
- The maximum seed treatment rate for field corn is reduced to 150 g a.i./100 kg seed. This results in the cancellation of the use for corn rootworm. No change is required for popcorn or sweet corn.
- For seed treatment uses on vegetables, the yearly maximum rate per hectare is limited to 100 g a.i./ha. This limits the planting rates used on broccoli, bulb onion, carrot, cabbage, cucumber and leek to meet this yearly maximum rate.
- The maximum foliar rate for use on cucurbits is reduced to a single application of 70 g a.i./ha per season. This results in the cancellation of use for brown marmorated stink bug.
- The maximum foliar rate for use on potatoes is reduced to a single application of 52.5 g a.i./ha per season.
- The maximum foliar rate for use on turf is reduced to a single application of 125 g a.i./ha per season. This results in the cancellation of use for hairy chinch bug, annual bluegrass weevil, bluegrass billbug and European crane fly.
- Cancellation of greenhouse seed treatment use for onion maggot and seed corn maggot on bulb onions, as these are only pests found in field production.
- New or revised spray buffer zones are required for freshwater habitats.
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 special review decision (SRD2021-03). The risks identified are not considered imminent and serious because they are not expected to cause irreversible harm over this phase-out period. Potential effects include reduced aquatic insect abundance. Affected populations have the potential to recover following implementation of the additional restrictions which will reduce overall exposure. 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.
This approach is consistent with Health Canada’s current policy and practice with respect to phase out of uses as a result of a re-evaluation (Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review).
Similarly, users will also have the same 24-month period from the date of SRD2021-03 to transition to using the newly amended labels, which will be available on the Public Registry.
A small subset of uses were found to lack suitable alternatives for the management of serious pests (the onion maggot and seedcorn maggot) on bunching onion (seed treatment). The effective date of the special review decision for these uses will be delayed for 24 months pursuant to subsection 21(3) of the Pest Control Products Act. The risk to aquatic invertebrates has been determined to be acceptable over this time period because the overall exposure to aquatic invertebrates will be significantly reduced through both removal of uses to control other pests on these crops and other crops posing a risk to aquatic invertebrates. Because of the overall reduction in use, exposure, and risk to aquatic invertebrates, the continued use for 24 additional months for these clothianidin uses with no suitable alternatives is not expected to impact aquatic invertebrate populations, and is considered acceptable.
Refer to Appendix I for details on specific products impacted by this decision.
Any person may file a notice of objectionFootnote 4 regarding this decision on clothianidin 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 the Canada.ca website (Request a Reconsideration of Decision) or contact the PMRA’s Pest Management Information Service by phone (1-800-267-6315) or by e-mail (firstname.lastname@example.org).
The relevant confidential test data on which the decision is based (as referenced in PSRD2018-01 and Appendix IX of SRD2021-03) 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 products containing clothianidin in Canada that are subject to this special review decision
|Registration number||Marketing class||Registrant||Product name||Formulation type||Active ingredient
|27449||Commercial||BASF Canada Inc.||Titan Insecticide||Suspension||Clothianidin 600 g/L|
|27453||Commercial||BASF Canada Inc.||Poncho 600 FS
|Suspension||Clothianidin 600 g/L|
|29158||Commercial||Bayer CropScience Inc.||Prosper T 200
|29159||Commercial||Bayer CropScience Inc.||Prosper FX
|Suspension||Clothinidin 285.7 g/L;
carbathiin 50 g/L;
metalaxyl 5.36 g/L
|30362||Commercial||Bayer CropScience Inc.||Emesto
penflufen 66.5 g/L
|30363||Commercial||Bayer CropScience Inc.||Prosper Evergol||Suspension||Clothianidin 290 g/L;
|30972||Commercial||Bayer CropScience Inc.||Sepresto 75 WS||Wettable
|31355||Commercial||Valent Canada Inc.||Nipsit Suite
|Suspension||Clothianidin 279 g/L;
metalaxyl 5.23 g/L;
|31357||Commercial||Valent Canada Inc.||Nipsit Suite
Cereals of Seed
|Suspension||Clothianidin 30.7 g/L;
metalaxyl 9.24 g/L;
|28975||Commercial||Valent Canada Inc.||Nipsit Inside
|29382||Commercial||Valent Canada Inc.||Clutch 50 WDG
|29383||Commercial||Valent Canada Inc.||Arena 50 WDG
|29384||Commercial||Valent Canada Inc.||Clothianidin
|Registration number||Marketing class||Registrant||Product name||Formulation type||Active ingredient (%, g/L)|
|Clothianidin Technical Insecticide||Solid||Clothianidin 97.5%|
Appendix II Registered commercial class uses of clothianidin in Canada as of 31 July 2020 that are subject to this special review
|Site(s)Footnote a||Pest(s)||Formulation type||Application methods and equipment||Application rateFootnote b||Maximum number of applications per year||Minimum application interva
|Change in application timing based on pollinator risk (RVD2019-05)Footnote cFootnote d|
|Use-site Category 10 – Seed and Plant Propagation Materials Food and Feed|
|Canola, rapeseed||Flea beetle||Suspension||Commercial seed treatment equipment||150–406 g a.i./100 kg seed
16.0–32.5 g a.i./ha
|Carinata||150–400 g a.i./100 kg seed
6.8–44.8 g a.i./ha
|Mustard||406 g a.i./100 kg seed
18.3–45.5 g a.i./ha
|Corn (field, sweet, pop)||Corn rootworm||Suspension||Commercial seed treatment equipment||1.25 mg a.i./kernel (375 g a.i./100 kg seed)
field 78.8–118.3 g a.i./ha
sweet 52.5–75.6 g a.i./ha
pop 85.3–123.8 g a.i./ha
|Corn flea beetle, black cutworm, seedcorn maggot, wireworm||0.25–0.5 mg a.i./kernel (75–150 g a.i./100 kg seed)
field 15.8–47.3 g a.i./ha
sweet 10.5–30.3 g a.i./ha
pop 17.1–49.5 g a.i./ha
|White grub (larvae of European chafer, May/ June beetle, Japanese beetle)||0.25 mg a.i./kernel (75 g a.i./100 kg seed)
field 15.8–23.7 g a.i./ha
sweet 10.5–15.1 g a.i./ha
popcorn 17.1 - 24.8 g a.i./ha
|Wheat||Wireworm||Suspension||Commercial seed treatment equipment||10–60 g a.i./100 kg seed
6.7–104.9 g a.i./ha
|Aphids||30 g a.i./100 kg seed
20.2–52.47 g a.i./ha
|Potato||Aphids, Colorado potato beetle, leafhoppers, potato flea beetle||Suspension||Ground application: Seed piece treatment equipment||6.2–12.48 g a.i./100 kg seed
119–381 g a.i./ha
|Wireworm||12.48 g a.i./100 kg seed
239–381 g a.i./ha
|Carrot||Carrot rust fly||Wettable powder||Seeds are not treated in Canada but are imported pre-treated with clothianidin.||0.035–0.068 g a.i. /1000 seed
31.5–275.4 g a.i./ha
|Leek||Onion maggot, seedcorn maggot, thrips||0.12 g a.i./1000 seed
46.2–92.4 g a.i./ha
|Onion (bulb)||0.12 g a.i./1000 seed
57.1–117.6 g a.i./ha
|Onion (bunching)||0.09 g a.i./1000 seed
176.4 g a.i./ha
|Lettuce||Aphids, leafminer||Wettable powder||Seeds are not treated in Canada but are imported pre-treated with clothianidin.||0.6 g a.i./1000 seed
420 g a.i./ha
|Broccoli, cabbage||Aphids, flea beetle||0.9 g a.i./1000 seed
75.6–110.3 g a.i./ha
|Pepper||Aphids, leafminer, thrips||0.25 g a.i./1000 seed
7.5 g a.i./ha
|Tomato||0.038 g a.i./1000 seed
0.6–14.6 g a.i./ha
|Cucumber||Aphids, thrips||0.75 g a.i./1000 seed
13.8–150 g a.i./ha
|Melon||0.75 g a.i./1000 seed
2.5–4.7 g a.i./ha
|Squash||0.75 g a.i./1000 seed
1.7–18.5 g a.i./ha
|Use-site Category 13 – Terrestrial Feed Crops & Use-site Category 14 – Terrestrial Food Crops|
|Potato||Colorado potato beetle, leafhoppers||Suspension||Ground application: In furrow||1.2–2 g a.i./100 m of row
132.6–223.8 g a.i./ha
|Colorado potato beetle||Water dispersible granule|
|Aphids, Colorado potato beetle, leafhoppers||Ground and aerial application: Foliar spray||35–52.5 g a.i./ha||3||7|
|Use-site Category 14 Only – Terrestrial Food Crops|
|Sweet potato||European Chafer, Japanese beetle, masked chafers, Asiatic garden beetle, Oriental beetle||Water dispersible granule||Ground application: soil drench||224 g a.i./ha||1||Not applicable|
|Grape||Leafhoppers||Water dispersible granule||Ground application: Foliar spray||50–70 g a.i./ha||1||Not applicable|
|Grape phyloxera, meallybug||70–105 g a.i./ha|
|Thrips||70 g a.i./ha|
|Brown marmorated stink bug||105 g a.i./ha|
|Crop Group 9: Cucurbit vegetables||Cucumber beetle, squash bug, tarnished plant bug||Water dispersible granule||Ground application: Foliar spray||70 g a.i./ha||1||Not applicable|
|Brown marmorated stink bug||105 g a.i./ha|
|Use-site Category 30 - Turf|
|Turf (golf courses and sod farms only)||European chafer, Japanese beetle, masked chafers, Asiatic garden beetle, Oriental beetle||Water dispersible granule||Ground application: Foliar spray||125–250 g a.i./ha||1||Not applicable|
|Hairy chinch bug||175–250 g a.i./ha|
|Annual bluegrass weevil||275–350 g a.i./ha|
|Bluegrass billbug||225 g a.i./ha|
|European crane fly||275 g a.i./ha|
Source: PMRA# 3139699
- Footnote 1
“Consultation statement” as required by subsection 28(2) of the Pest Control Products Act
- Footnote 2
For further details on the environmental monitoring network please refer to Section 1.5.1 of the Response to Comments.
- Footnote 3
“Decision statement” as required by subsection 28(5) of the Pest Control Products Act.
- Footnote 4
As per subsection 35(1) of the Pest Control Products Act.
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