PMRA Guidance Document, Tank Mix Labelling

Organization: Health Canada

Date published: March 2023

Health Canada - Pest Management Regulatory Agency
16 March 2023

Table of contents

• Disclaimer
• 1.0 Purpose
• 2.0 Background
• 3.0 Label Statements that Permit Tank Mixing
• 4.0 Label Statements that Preclude Tank Mixing
• 5.0 Other Label Statements That Make Reference to Tank Mixing
• 6.0 Amending the Product Label
• 7.0 Promotion, Advertising and Marketing of Tank Mixes
• 8.0 Implementation
• Appendix A - Examples

Disclaimer

This document does not constitute part of the Pest Control Products Act or its regulations and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies.

1.0 Purpose

The purpose of this Guidance Document is to provide further clarity to all stakeholders regarding product labelling related to tank mixes.

2.0 Background

On 3 July 2020, Health Canada's Pest Management Regulatory Agency (PMRA) published Regulatory Proposal PRO2020-01, Streamlined Category B Submissions and Tank Mix Labelling. The purpose of this document was to clarify the eligibility and conditions for Streamlined Category B Submissions, which have replaced Category C Submission efficacy reviews, and to clarify and consolidate guidance related to tank mix labelling.

Several comments related to tank mix labelling were received during the public comment period. In consideration of these, this guidance document provides additional clarity as well as some modifications to the proposal articulated in PRO2020-01. The content of PRO2020-01 related to Streamlined Category B submissions will not be modified, and a separate guidance document on this subject will be published in the near future.

3.0 Label statements that permit tank mixing

Paragraph 6(5)(b) of the Pest Control Products Act states that no person shall use a pest control product in a way that is inconsistent with the directions on the label. As a result, if a label contains no guidance related to tank mixing, then tank mixes are not permitted.

Therefore, in order for tank mixing to be permitted, there must be text on the product label that specifically allows for tank mixing. This text may be in one of two forms: a specific mention of the tank mix partners (for example, Product X may be tank mixed with Product Y), or the general label statement that permits tank mixing.

3.1 Identification of specific tank mix partners

Specific tank mixes are typically required to identify the tank mix partner by its product name. However, in some cases, a more general reference to the active ingredient may be possible. In addition to the identification of the tank mix partner, the tank mix partner application rate and any additional pests controlled by the tank mix may also be included on the label. Alternatively, a statement referring the user to the tank mix partner label may be included.

Specific tank mixes may appear on the label of one or both tank mix partner labels. There is no requirement for the tank mix to appear on both tank mix partner labels.

3.2 General reference to tank mixing

The general label statement that permits tank mixing was proposed in PRO2020-01, and in consideration of the comments received during the public comment period, it is being modified to allow greater flexibility in terms of tank mixing options. Specifically, the prohibition against tank mixing products with the same mode of action has been removed, and the reference to tank mixing with a fertilizer is now an optional component of that statement. The general label statement now reads as follows:

"This product may be tank mixed with (a fertilizer, a supplement, or with) registered pest control products, whose labels also allow tank mixing, provided the entirety of both labels, including Directions For Use, Precautions, Restrictions, Environmental Precautions, and Spray Buffer Zones are followed for each product. In cases where these requirements differ between the tank mix partner labels, the most restrictive label must be followed. Do not tank mix products containing the same active ingredient unless specifically listed on this label.

In some cases, tank mixing pest control products can result in reduced pesticide efficacy or increased host crop injury. The user should contact [insert registrant name] at [insert contact information] for information before applying any tank mix that is not specifically recommended on this label."

This general label statement would apply to the entire product label and need only appear once on the label. Should there be concerns related to specific tank mix combinations, or to specific crops, registrants may choose to only list specific tank mixes, or to indicate that for certain crops on the label, only tank mixes that are specifically listed on the label may be applied to that crop. Further, if the general label statement is included on the label, contraindications against specific tank mixes may be proposed. This general label statement would typically only be considered for products with agricultural or vegetation management uses; its applicability to other product types may be considered on a case by case basis. This general label statement is not permitted to appear on adjuvant labels.

Consequently, product labels may be silent with respect to tank mixing (in which case tank mixing is not permitted), contain a list of specific tank mix partners, the general label statement, or both. There is no requirement to list every specific tank mix on the product label. Users of pest control products would have the option of applying tank mixes that are specifically identified on product labels, as well as applying tank mixes of products where each tank mix partner label contains the general label statement related to tank mixing, provided all requirements on the labels can be followed.

Pest control product labels that permit tank mixing (either in the specific or general sense as described above) may also include additional directions related to mixing order and methods to determine physical compatibility of tank mix partners (for example, a jar test). Labels that are silent with regards to tank mixing may not include these types of statements.

4.0 Label statements that preclude tank mixing

Some labels contain statements that preclude or limit tank mixing. For example,

"Do not mix or apply this product with any other additive, pesticide or fertilizer except as specifically recommended on this label."

The presence of this type of exclusionary statement would preclude tank mixing the product with any other product that is not specifically identified on the product label, and would preclude the addition of specific tank mixes for the product on other product labels. Further, this type of exclusionary statement is incompatible with the general label statement above, and as such, both statements may not appear on the same label.

To illustrate, if such an exclusionary statement were to appear on the label of Product X, then the Product X label may not include the general label statement related to tank mixing; it could only include a list of specific tank mix partners. Additionally, no other product, for example, Product Y, could specify a tank mix with Product X on its own label, unless that product is specifically identified as a tank mix partner on the label for Product X.

Given the complexities and limitations related to this type of exclusionary statement, registrants are advised to carefully consider whether or not they choose to include them on a product label. Further, registrants are encouraged to pay close attention to these types of exclusionary label statements when considering the addition of specific tank mix combinations to their product labels, and to coordinate with other registrants as required, such that the addition of the tank mixes may be considered. Given paragraph 6(5)(b) of the Pest Control Products Act, there is no need to include an exclusionary statement on the label to limit tank mixing to only those specific tank mixes listed on a product label, if any. Appendix A provides examples of combinations of label text that might appear on product labels and indicates under which scenarios the application of a tank mix would be permitted.

5.0 Other label statements that make reference to tank mixing

Pesticide labels often contain other statements that make reference to tank mixing. It is important to note that, while these statements do reference tank mixing, they do not permit tank mixing, but rather that they are conditional upon tank mixing being allowed elsewhere on the label.

For example,

"When tank mixes are permitted, read and observe all label directions, including rates and restrictions for each product used in the tank-mix. Follow the more stringent label precautionary measures for mixing, loading and applying stated on both product labels."

"When tank mixes are permitted, consult the labels of the tank mix partners and observe the largest (most restrictive) spray buffer zone of the products involved in the tank mixture and apply using the coarsest spray (ASAE) category indicated on the labels for those tank mix partners."

"Use tank mixtures with [fungicides/bactericides/insecticides/acaricides] from a different group that is effective on the target [pathogen/pest] when such use is permitted."

6.0 Amending the product label

The addition of the general label statement related to tank mixing and/or specific tank mix combinations to labels will continue per established processes, namely Category A, B (including Streamlined) and C submissions.

Exclusionary statements related to tank mixing that currently appear on a label may be removed at the registrant's request by notification, or as part of a Category B or C submission. Registrants are also required to remove the pre-existing statement related to unlabelled tank mixes (Section 7.11 of DIR2016-02, Notification/Non-notification) from their product labels. This may be done by notification, or as part of a Category B or C submission. Timelines to complete these amendments are described in Section 8.

7.0 Promotion, advertising and marketing of tank mixes

Registrants, extension specialists and crop advisors are permitted to recommend, promote, advertise and market tank mixes that specifically appear on one or more tank mix partner labels, and tank mixes of products whose labels contain the general label statement related to tank mixing, provided all tank mix partner labels contain the statement.

8.0 Implementation

Registrants will have until 20 December 2024 to update their product labels and marketing, promotional and extension material. Specific actions required include:

• Removal of the pre-existing label statement related to unlabelled tank mixing (Section 7.11 of DIR2016-02, Notification/Non-notification) from labels,
• Remove any reference to unlabelled tank mixes from marketing, promotional and extension material (including websites),
• Update marketing, promotional and extension material (including websites) to only reference tank mixes that are compliant with the labelling requirements described in this document.

To minimize resource implications, registrants are advised to make these changes in combination with other label changes being proposed under open submissions. During this transition period, the PMRA will actively monitor open submissions for products whose labels are inconsistent with this document, and communicate options to registrants, and make consequential amendments to other documents published by the PMRA as specified in PRO2020-01. As a number of guidance documents and product labels are to be modified in the coming transitional period, provinces and other providers of extension material will be provided the same timeframe (i.e., until 20 December 2024) to update their extension material to align with amended product labels and guidance documents. Similarly, users of pest control products will be provided the same transitional period to adjust their purchasing and production practices to algin with the provisions of this document.

Appendix A - Examples

Examples of different tank mix wording scenarios on the permissibility of tank mixing two registered pest control products.

Table 1 Permissibility of tank mixing based on various combinations of label statements related to tank mixing