Re-evaluation Decision RVD2018-39, Ziram and Its Associated End-use Products for Agricultural Uses

Pest Management Regulatory Agency
14 December 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-39E-PDF (PDF version)

Summary

Table of Contents

• Re-evaluation Decision
• Outcome of Science Evaluation
• Regulatory Decision for Ziram
• Next Steps
• Other Information
• Appendix I    Registered Agricultural Ziram Products in Canada

Re-evaluation Decision

Under the authority of the Pest Control Products Act, all registered pesticides must be regularly re-evaluated by Health Canada’s Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental safety standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Ziram is a protectant fungicide registered for control of various fungal diseases on apples, peaches and apricots regionally in British Columbia; and nationally on cucumbers, tomatoes, melons, pumpkins and squash. Currently registered products containing ziram for agricultural uses are listed in Appendix I.

Ziram is also used as a material preservative. However, Health Canada plans to publish a separate document in the future examining the material preservative use of ziram. Further details may be found in the published document: Re-evaluation Note REV2018-02, Approach for the Re-evaluation of Pesticides Used as Preservatives in Paints, Coatings and Related Uses. As such, this document applies to agricultural uses of ziram only.

The regulatory approach for the re-evaluation of ziram was first presented in the Proposed Re-evaluation Decision PRVD2016-06, Ziram.^{Footnote 1} PRVD2016-06 proposed the cancellation of all registered uses and the revocation of all maximum residue limits (MRLs) as health and environmental risks were not found to be acceptable. Health Canada received comments relating to the health and value assessments. These comments are summarized in Appendix II of Re-evaluation Decision RVD2018-39, Ziram and Its Associated End-use Products for Agricultural Uses along with the responses by Health Canada. These comments and new data/information resulted in revisions to the risk assessments (see Science Evaluation Update section of RVD2018-39), but did not result in changes to the proposed re-evaluation decision as described in PRVD2016-06. A reference list of data used as the basis for the proposed re-evaluation decision is included in PRVD2016-06, and further data used in the re-evaluation decision is listed in RVD2018-39.

Re-evaluation Decision RVD2018-39 presents the final re-evaluation decision^{Footnote 2} for ziram agricultural uses, which is cancelling all agricultural products containing ziram to protect human health. All agricultural products containing ziram that are registered in Canada are subject to this re-evaluation decision.

Outcome of Science Evaluation

Health risks from the use of ziram and its associated end-use products have not been shown to be acceptable for any agricultural use, when used according to current label directions, or when additional mitigation measures are considered. The environmental risks associated with the use of ziram and its associated end-use products are acceptable when used according to revised label directions. Health Canada recognises the value of ziram to fruit crops, including the need for control and resistance management of pin-point scab on apples, and coryneum blight (shot hole disease) on peaches and apricots in British Columbia.

Regulatory Decision for Ziram

Health Canada has completed the re-evaluation of ziram for agricultural uses. Under the authority of the Pest Control Products Act, Health Canada is cancelling the registration of all currently registered agricultural uses of ziram in Canada. An evaluation of the available scientific information found that all agricultural uses of ziram have not been shown to have acceptable health risks when used according to the current label directions, or when additional mitigation measures are considered. No additional data are required.

All ziram MRLs will be revoked as all currently registered food uses are cancelled. Consultation on the revocation of all ziram MRLs will be conducted via a Proposed Maximum Residue Limit (PMRL) document.

Next Steps

To comply with this decision, products for agricultural uses are to be phased out following the implementation timeline outlined below. Appendix I lists the agricultural products containing ziram that are registered under the authority of the Pest Control Products Act.

• One (1) year of sale by registrant from the publication date of this decision document, followed by;
• One (1) year of sale by retailer from the last date of sale by registrant, followed by;
• One (1) year of permitted use from the last date of sale by retailer.

Other Information

Any person may file a notice of objection^{Footnote 3} regarding this decision on ziram within 60 days from the date of publication of RVD2018-39. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of Canada.ca or contact the PMRA’s Pest Management Information Service.

Appendix I  Registered Agricultural Ziram Products in Canada

Table 1      Registered Ziram Products in Canada as of 17 May 2018, excluding discontinued products and products with a submission for discontinuation

Registration Number	Marketing Class	Registrant	Product Name	Formulation Type	Guarantee
28426	Technical	Taminco US LLC.	Ziram Technical (98.4%)	Dust	98.4%
29140	Commercial	Loveland Products Canada Inc.	Ziram 85W Fungicide	Wettable powder	85%
29685	Commercial	Taminco US LLC.	Ziram Granuflo	Wettable granules	76%