Re-evaluation Decision RVD2019-06, Imidacloprid and Its Associated End-use Products: Pollinator Re-evaluation

Pest Management Regulatory Agency
11 April 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2019-6E-PDF (PDF version)

Summary

Table of Contents

• Re-evaluation Decision
• Outcome of Science Evaluation
• Regulatory Decision for Imidacloprid
• Next Steps
• Other Information
• Appendix I - Registered Imidacloprid Products in Canada Subject to This Re-evaluation

Re-evaluation Decision

Under the authority of the Pest Control Products Act, Health Canada’s Pest Management Regulatory Agency (PMRA) conducted a re-evaluation of all agricultural, turf and ornamental uses for imidacloprid and its associated end-use products, specifically to assess the risk to pollinators, such as honey bees, bumble bees, and solitary bees. This re-evaluation assessed the potential risk to pollinators in light of international updates to the pollinator risk assessment framework. Extensive information obtained from published literature was considered, as well as data received from registrants. Health Canada applied internationally accepted risk assessment methods as well as current risk management approaches and policies. In addition to the pollinator risk assessment, the value of the active ingredient to the use sector was considered.

Products containing imidacloprid are sold as sprays to be applied to plants and to bare soil. Imidacloprid is also used as a coating on crop seeds to prevent insects from eating the seeds when they are planted in the ground and to protect the plants grown from treated seeds. Some uses result in imidacloprid being taken up by the plants from the soil or through their leaves, where it then moves into parts of the flower where nectar and pollen are produced. As a result of bees using nectar and pollen as their primary sources of food, bees may be exposed to imidacloprid (and its breakdown products) when they visit certain flowers to collect pollen and nectar. Bees may also be accidentally sprayed or collect water containing imidacloprid. Currently registered products containing imidacloprid that are subject to this re-evaluation are listed in Appendix I.

This document (RVD2019-06, Imidacloprid and Its Associated End-use Products: Pollinator Re-evaluation) presents the final regulatory decision^{Footnote 1} for the pollinator re-evaluation of imidacloprid, including the required risk mitigation measures to protect bees. Most products containing imidacloprid that are registered in Canada are subject to this regulatory decision. The proposed regulatory decision published in PRVD2018-12, Imidacloprid and Its Associated End-use Products: Pollinator Re-evaluation,^{Footnote 2} has undergone a 90-day consultation that ended on 29 August 2018.

In addition to many comments expressing a concern for pollinator health, Health Canada received comments relating to both the value and pollinator risk assessments. These comments are in Appendix II of RVD2019-06, Imidacloprid and Its Associated End-use Products: Pollinator Re-evaluation, along with the responses by Health Canada. These comments and new data/information resulted in a minor revision to the risk assessment (see the Science Evaluation Update section of RVD2019-06) and, subsequently, in changes to the proposed regulatory decision as described in PRVD2018-12. All of the data that were used as the basis for the proposed re-evaluation decision are published in PRVD2018-12. Further data used in the final re-evaluation decision, including data received during the consultation period, are listed in Appendix IV of RVD2019-06.

Outcome of Science Evaluation

This risk assessment, conducted according to the Guidance for Assessing Pesticide Risks to Bees,^{Footnote 3} determined that there are varying degrees of effects on bees. Some current uses of imidacloprid are not expected to affect bees. For some uses, mitigation measures (that is, changes to the conditions of registration) are required to minimize potential exposure to bees. Mitigation measures include changes to the use pattern and label improvements. When imidacloprid is used in accordance with these new risk reduction measures, the reduced environmental exposure is considered adequate and risks are acceptable. Label statements informing users of the potential for toxicity to pollinators are required on product labels. For other uses, risks to pollinators were not found to be acceptable; therefore, these uses are cancelled.

Regulatory Decision for Imidacloprid

Health Canada has completed the pollinator re-evaluation of imidacloprid. Under the authority of the Pest Control Products Act, Health Canada has determined that, with required amendments, continued registration of products containing imidacloprid is acceptable; however, certain uses of imidacloprid are cancelled to address potential risks of concern to pollinators. An evaluation of available scientific information found that some uses of imidacloprid products meet current standards for protection of pollinators when used according to the conditions of registration, which include required amendments to label directions. Label amendments, as summarized below and listed in Appendix III of RVD2019-06, are required for all end-use products. No additional data are requested.

Risk Mitigation Measures to Protect Pollinators

Registered pesticide product labels include specific direction for use. Directions include risk mitigation measures to protect the environment and must be followed by law. As a result of this re-evaluation of imidacloprid, further risk mitigation measures for product labels are required.

Certain crops are highly attractive to bees when their flowers are in bloom. Since large numbers of bees are attracted to these crops when they are in bloom and based on an assessment of the risks to bees, the application of pesticides containing imidacloprid can lead to effects that may have an impact on the survival of bee colonies or solitary bee species.

In order to protect pollinators, Health Canada is cancelling the following uses of imidacloprid:

• Foliar application to pome fruit, stone fruit, certain tree nuts with high pollinator attractiveness, lavender and rosemary;
• Soil application on legume, fruiting, and cucurbit vegetables when grown outdoors; herbs harvested after bloom; small fruit and berries (caneberry; bushberry; low-growing berry; berry and small fruit vine excluding grapes); and ornamentals that are attractive to pollinators and planted outside.

In order to protect pollinators, Health Canada is proposing that the following crops cannot be sprayed before or during bloom:

• Foliar application to fruiting vegetables, herbs that are harvested after bloom, legume vegetables (broad beans/fava beans/Vicia faba only), berry crops (with renovation after harvest for woody berries), tree nuts excluding those with high pollinator attractiveness.

In order to protect pollinators, Health Canada is proposing that the following crops cannot be sprayed during bloom:

• Foliar application to potato, grapes, legume vegetables (excluding broad beans/fava beans/Vicia faba), peanut, and tobacco.

To minimize bee exposure to dust during planting of treated seed, additional label statements are proposed for the following use:

• Seed treatment of cereal and legume crops.

The additional risk mitigation measures described above will be implemented over a 24-month period. The risks identified are not considered imminent because they are not expected to cause irreversible harm over this period. Potential effects include sublethal effects on colonies or solitary bees, but affected pollinator populations are expected to recover following implementation of the additional restrictions which will reduce exposure. Moreover, recovery is expected because risks to pollinators are geographically limited to areas where these products are applied and areas adjacent to application sites. The presence of unaffected solitary bees, bumble bees, and honey bees in areas where products are not being used will further facilitate recovery since unaffected bees in the environment can move back into areas where effects may have occurred. Overall, risk to pollinators is acceptable over the time period required to implement the mitigation measures.

As a result of this decision, growers will be required to change their pest management practices.  Pesticides have extensive and precise instructions and often require specialized application and safety equipment and training. This transition period will allow for an orderly and safe implementation of these new restrictions, and should reduce the risk of product misuse or the improper disposal of products as users switch to alternatives, where required. 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) and with the practice of other international regulators.

A small subset of uses were found to lack alternatives for the management of serious pests (European chafer, certain beetles, and leafhoppers) on a very few crops present in limited geographical areas of Canada. As a result, the implementation of the re-evaluation decision for these uses will be delayed for an additional year to allow growers to find pest management solutions. During this period, the overall exposure to pollinators will be significantly reduced through both removal of uses to control other pests on these crops and other crops that pose a risk to bees, as well as through implementation of additional restrictions in application timing which will further reduce pollinator exposure. The risks to pollinators are therefore considered acceptable for an additional year for this small subset of uses.

Next Steps

To comply with this decision, taking into account Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review, the required mitigation measures must be implemented on all product labels sold by registrants no later than 24 months after the publication date of this decision document. Appendix I lists the products containing imidacloprid that are registered under the authority of the Pest Control Products Act.

Other Information

Any person may file a notice of objection^{Footnote 4} regarding this decision on imidacloprid within 60 days from the date of publication of this Re-evaluation 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.

Appendix I - Registered Imidacloprid Products in Canada Subject to This Re-evaluation

Table 1 -  Registered Imidacloprid Products in Canada Subject to This Re-evaluation as of 12 February 2019, excluding discontinued products and products with a submission to discontinue

Registrant	Marketing Class	Registration Number	Product Name	Formulation type	Guarantee
Bayer CropScience Inc.	Technical grade active ingredient	24468	Bay NTN 33893 Technical Insecticide	Solid	Imidacloprid 98%
	Manufacturing concentrate	25390	Merit 75% Concentrate Insecticide	Wettable powder	Imidacloprid 75%
	Commercial	24094	Admire 240 Flowable Systemic Insecticide	Suspension	Imidacloprid 240 g/L
		25636	Merit 60 WP Greenhouse And Nursery Insecticide	Wettable powder	Imidacloprid 60%
		25932	Merit Solupack Insecticide		Imidacloprid 75%
		25933	Merit Granular	Granular	Imidacloprid 0.5%
		26124	Gaucho 480 FL Insecticide	Suspension	Imidacloprid 480 g/L
		27170	Gaucho 600 FL Insecticide		Imidacloprid 600 g/L
		27174	Gaucho CS FL (Insecticide/Fungicide Seed Treatment)		Carbathiin 47.6 g/L Thiram 95.3 g/L Imidacloprid 285.7 g/L
		27349	Genesis 240 Flowable Systemic Insecticide		Imidacloprid 240 g/L
		27357	Intercept 60 WP Greenhouse Insecticide	Wettable powder	Imidacloprid 60%
		27702	Admire 240 SPT Flowable Systemic Insecticide	Suspension	Imidacloprid 240 g/L
		29609	Stress Shield For Cereals	Suspension	Imidacloprid 480 g/L
		29610	Stress Shield For Cereals and Soybeans
		29611	Concept Liquid Insecticide	Suspension	Imidacloprid 75 g/L deltamethrin 10 g/L
		30668	Stress Shield 600	Suspension	Imidacloprid 600 g/L
		30972	Sepresto 75 WS	Wettable Powder	Imidacloprid 18.75% clothianidin 56.25%
		31068	Acceleron IX-409 Insecticide Seed Treatment	Suspension	Imidacloprid 600 g/L
	Commercial + Restricted	29703	Confidor 200 SL	Solution	Imidacloprid 17.1%
Adama Agricultural Solutions Limited	Technical grade active ingredient	30374	MANA Imidacloprid Technical	Solid	Imidacloprid 98.3%
	Commercial	28475	Alias 240 SC Systemic Insecticide	Suspension	Imidacloprid 240 g/L
		29130	Quali-Pro Imidacloprid 75 WSP Insecticide	Wettable powder	Imidacloprid 75%
		29185	Quali-Pro Imidacloprid 0.5 Granular Insecticide	Granular	Imidacloprid 0.5%
		30505	Sombrero 600 FS	Suspension	Imidacloprid 600 g/L
FMC Corporation	Commercial	28726	Grapple Insecticide	Suspension	Imidacloprid 240 g/L
		29048	Grapple-2 Insecticide
Arborjet Inc.	Commercial + Restricted	31375	IMA- Jet	Solution	Imidacloprid 58.5 g/L
		31479	IMA-Jet 10		Imidacloprid 117 g/L
Sharda Cropchem Limited	Technical grade active ingredient	32645	Imidacloprid Technical Insecticide	Solid	Imidacloprid 98.53%
SBM Life Science Corporation	Domestic	29738	Bioadvanced Science-Based Solutions Season Long Grub Control	Granular	Imidacloprid 0.25%