Re-evaluation Decision RVD2020-12, Mancozeb and Its Associated End-use Products

Pest Management Regulatory Agency
19 November 2020
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2020-12-PDF (PDF version)

Summary

Table of contents

• Re-evaluation decision for mancozeb and associated end-use products
• Re-evaluation decision for mancozeb
• Risk mitigation measures
• Next steps
• Other information

Re-evaluation decision for mancozeb and associated end-use products

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

Mancozeb is a multi-site contact fungicide. It is currently registered for the management of a large number of diseases on a variety of fruits and vegetable crops, outdoor ornamentals, forestry uses, greenhouse vegetables, greenhouse tobacco transplants, and seed treatments (including potato seed piece treatment). Mancozeb products are applied as a foliar treatment by ground and aerial application, as an in-furrow application and as a seed treatment. Mancozeb belongs to the group of fungicides commonly known as ethylene bis (dithiocarbamates) (EBDCs), along with the active ingredients metiram, maneb and nabam. In Canada, nabam has no registered food uses and maneb is not registered in Canada, which leave only mancozeb and metiram with food uses (metiram is registered for use on potato only). These EBDCs decompose to ethylene thiourea (ETU), whose cumulative risk profile is also taken into account in this re-evalution. Currently registered products containing mancozeb can be found in the Pesticide Label Search and in Appendix I of RVD2020-12. The Proposed Re-evaluation Decision PRVD2018-17, Mancozeb and its Associated End-use Products,^{Footnote 1} containing the evaluation of mancozeb and proposed decision, underwent a 90-day consultation period ending on 3 January 2019. PRVD2018-17 proposed the cancellation of all uses of mancozeb, except greenhouse tobacco, due to risks to human health and the environment that were not found to be acceptable.

Health Canada received comments and information relating to the health, environmental and value assessments. Commenters are listed in Appendix III of RVD2020-12. These comments are summarized in Appendix IV of RVD2020-12 along with the responses by Health Canada. These comments and new data/information resulted in revisions to the toxicology, dietary, occupational and environmental risk assessments (see Science evaluation update of RVD2020-12), and resulted in changes to the proposed re-evaluation decision as described in PRVD2018-17.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2018-17, and further information used in the re-evaluation decision is listed in Appendix XI of RVD2020-12. Therefore, the complete reference list of all information used in this final re-evaluation decision includes both the information set out in PRVD2018-17 and the information set out in Appendix XI of RVD2020-12.

This document (Re-evaluation Decision RVD2020-12, Mancozeb and Its Associated End-use Products) presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of mancozeb, including the required amendments (risk mitigation measures) to protect human health and the environment, and any label amendments required to bring labels to current standards. All products containing mancozeb that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for mancozeb

Health Canada has completed the re-evaluation of mancozeb. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing mancozeb is acceptable with additional risk mitigation measures. An evaluation of available scientific information found that the registrant supported uses of mancozeb products (ground and aerial foliar application to potatoes; ground foliar application on apples, onions, sugar beets, ginseng, field cucumbers, field tomatoes, grapes, pumpkin, squash, and melon (including cantaloupe but excluding watermelon and in-furrow application to onions) meet current standards for protection of human health and the environment and have value when used according to the revised conditions of registration which includes new mitigation measures. Label amendments, as summarized below and listed in Appendix X of RVD2020-12, are required.

Risk mitigation measures

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 mitigation measures, as a result of the re-evaluation of mancozeb, are summarized below. Refer to Appendix X of RVD2020-12 for details.

Uses not supported by manufacturers for re-evaluation will be removed from all product labels:

The following uses, formulations and application methods of mancozeb are cancelled due to lack of support from the manufacturers and were therefore not included in the updated assessments:

• All seed treatments (including potato seed piece treatment), greenhouse uses (in other words, tobacco, tomatoes), use on pears, carrots, celery, lettuce, watermelon, lentils, wheat, alfalfa grown for seed, as well as ornamentals and forestry uses.
• All applications using any hand held equipment.
• All end-use (commercial class) wettable powder or dust formulations.

Human health

Risk mitigation:

To protect workers, those entering treated areas, bystanders and the general public from occupational, residential, and dietary exposure, the following risk-reduction measures are required for continued registration of mancozeb in Canada:

The following uses are acceptable with the mitigation measures outlined below:

• Foliar application to potatoes, apples, onions, sugar beets, ginseng, field cucumbers, field tomatoes, grapes, pumpkin, squash, and melons, including cantaloupe but excluding watermelon.
• In-furrow application to onions.

Required mitigation measures:

• Applications to the above crops must occur at the reduced use pattern (lower application rate and/or maximum number of applications per year; new or longer preharvest intervals (PHIs) and application intervals) as proposed by the registrant(s).
• Engineering controls and personal protective equipment (PPE).
• Prohibition of use by handheld equipment.
• Prohibition of application by hand.
• Requirement for longer restricted-entry intervals (REIs) for certain crops and postapplication activities.
• Prohibition of use in residential areas.
• Revision of the residue definition for mancozeb to “mancozeb expressed as carbon disulfide (CS2)”.
• Revision of MRLs for crops supported by manufacturers to reflect the new residue definition and the reduced use pattern (lower application rate and/or maximum number of applications per year, new or longer PHIs and application intervals).
• Revocation of all other MRLs for mancozeb (that is, EBDC MRLs).

To reduce potential exposure to ethylene thiourea (ETU) from use of multiple ethylenebisdithiocarbamate (EBDC) pesticides:

• Requirement for a label statement limiting applications of both mancozeb and metiram so that the total quantity of active ingredients does not exceed the specified maximum seasonal rate for either active ingredient.

To protect bystanders from spray drift:

• Requirement for a label statement to promote best management practices to minimize human exposure from spray drift or spray residues resulting from drift.

Environment

Risk mitigation:

To protect the environment, the following risk-reduction measures are required:

• Standard label statements are required to minimize potential risks resulting from runoff.
• Standard label statements to inform users of the potential toxic effects to sensitive biota.
• Buffer zones are required to mitigate risks from spray drift.
• Hazard statements are required on product labels warning of the potential for leaching and groundwater contamination.
• Updated discharge of effluent statements.
• Updated storage statements.

Value

Label improvements to meet current standards:

• Update labels according to Regulatory Directive DIR2013-04, Pesticide Resistance Management Labelling Based on Target Site/Mode of Action, including updating the fungicide group code to M3.
• Tank mix partners must be clearly indicated, by product name, on mancozeb product labels. Specific directions regarding use of the tank mix, or a reference to the tank mix partner label, must be included. A general reference that "this product can be tank mixed with other products" is not acceptable. Therefore, remove any vague or non-specific claims that the product can be tank mixed with another pesticide.

Risk mitigation:

• Remove any vague reference to “apply as needed”, or “apply as required”. Directions for Use should reflect the use-specific re-application interval.

Next steps

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 RVD2020-12. 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. Similarly, users will also have the same 24-month period from the date of RVD2020-12 to transition to using the newly amended labels, which will be available on the Public Registry.

Products that are cancelled will be phased out following the implementation timeline outlined below.

• 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.

Refer to Appendix I of RVD2020-12 for details on specific products impacted by this decision.

Other information

Any person may file a notice of objection^{Footnote 3} regarding this decision on mancozeb and its associated end-use products 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 by phone (1-800-267-6315) or by e-mail (hc.pmra-info-arla.sc@canada.ca).

The relevant confidential test data on which the decision is based (as referenced in PRVD2018‑17 and in Appendix XI of RVD2020-20) are available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa). For more information, please contact the PMRA’s Pest Management Information Service.