Proposed Re-evaluation Decision PRVD2018-17, Mancozeb and its Associated End-use Products
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This consultation is now closed.
Pest Management Regulatory Agency
5 October 2018
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2018-17E-PDF (PDF version)
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Table of Contents
- Proposed Re-evaluation Decision
- Outcome of Science Evaluation
- Proposed Regulatory Decision for Mancozeb
- International Context
- Next Steps
- Additional Information
Proposed Re-evaluation Decision
Under 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. The PMRA applies internationally accepted risk assessment methods as well as current risk management approaches and policies.
Mancozeb is a protectant contact fungicide with multi-site mode of action used to control a broad spectrum of plant diseases on a wide variety of food and feed crops, as well as uses in forests and woodlots, outdoor ornamentals and greenhouse food crops. Mancozeb belongs to the group of fungicides commonly known as ethylene bis (dithiocarbamates) (EBDCs), along with the active ingredients maneb, zineb, metiram and nabam. It should be noted that in Canada, nabam has no registered food uses and maneb and zineb have been voluntarily discontinued. The EBDCs decompose and/or metabolize to ethylene thiourea (ETU), whose cumulative risk profile is also being taken into account.
A Proposed Re-evaluation Decision document was first published on 30 July 2013 (PRVD2013-01). Subsequently, on 24 August 2018, the PMRA indicated that it will be re-issuing a Proposed Re-evaluation Decision document (PRVD) in respect of mancozeb and its associated end-use products to allow for an informed consultation to take place. Although PRVD2013-01 for mancozeb outlined dietary risks of concern, the associated risk management proposal (that is, the proposed regulatory decision) was inadvertently not included. The proposal should have stated, based on the dietary and environmental risk assessments, that all uses were proposed to be cancelled, except greenhouse tobacco, rather than stating that certain uses were proposed for continued registration with further risk-reduction measures proposed. When conducting the mandatory consultation during a re-evaluation, the Pest Control Products Act requires that a summary of any evaluation, the proposed decision and the reasons for it be set out in the consultation document (the PRVD).
As a result, the final decision document (RVD2018-21) has been withdrawn and there will be no changes to the labels or registration status of the existing products, pending the completion of this re-evaluation (i.e., until a new re-evaluation decision is issued (RVD)). In addition, the mancozeb-related information in the Proposed Maximum Residue Limit document for EBDC Fungicides (PMRL2018-27) was also withdrawn because it is based on the conclusions reached in RVD2018-21.
The present document (PRVD2018-17, Mancozeb and its Associated End-use Products) is a re-issuance of PRVD2013-01, which now includes a complete summary of the evaluations undertaken up until that time, the proposed decision and the reasons for it. As such, this consultation document (PRVD2018-17) is based on the use pattern and the registration status of maconzeb at the time PRVD2013-01 was originally issued.
Outcome of Science Evaluation
An evaluation of available scientific information found that, under the current conditions of use:
- Dietary risks from food alone and drinking water alone were identified and not found to be acceptable when all the uses on the current labels, except greenhouse tobacco, were considered. Therefore, all uses, with the exception of greenhouse tobacco, are proposed for cancellation.
- Although not a food use, the forestry and woodlot uses are proposed for cancellation due to potential residues occurring in drinking water, for which risks from outdoor applications have been identified and not found to be acceptable, as noted above. Therefore, these uses are proposed for cancellation.
- Occupational risks (postapplication) were identified and not found to be acceptable for apples, pears, grapes and greenhouse tomatoes. Occupational mixer/loader/applicator risks were identified and not found to be acceptable for potato seed piece treatment, and seed treatment for barley, corn, flax, oat and wheat, except for on-farm slurry application. Therefore, these uses are proposed for cancellation.
- Postapplication risks for workers were found to be acceptable for most agricultural label uses when the proposed mitigation measures (Restricted-Entry Intervals) are applied. However, for apples, pears and grapes and greenhouse tomatoes, some or all of the proposed restricted-entry intervals (REIs) are not believed to be agronomically feasible and these uses are therefore proposed for cancellation.
- The use on greenhouse tobacco would not result in dietary exposure and occupational risks were found to be acceptable with additional risk mitigation measures. Therefore, this use is proposed for continued registration.
- Environmental risks to birds and small wild mammals were identified for foliar sprays of mancozeb on all crops and were not found to be acceptable. Therefore, all foliar applications are proposed for cancellation.
Proposed Regulatory Decision for Mancozeb
Under the authority of the Pest Control Products Act, Health Canada is proposing 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.
During the phase-out period of all uses, except greenhouse tobacco, the following additional risk mitigation measures may be required, unless scientific data and/or changes to the use pattern are adequately address the human health and environmental risks identified above:
- Packaging of all wettable powder products in water soluble packages.
- Additional protective equipment (respirator) and/or engineering controls (closed cab).
- Lengthened restricted-entry intervals are to be added to product labels.
- Additional label statement limiting applications of both mancozeb and metiram so that the total quantity of active does not exceed the specified maximum seasonal quantity for either mancozeb or metiram.
- Additional precautionary label statements to help reduce runoff and to protect non-target aquatic species.
- The use of spray buffer zones to protect for non-target aquatic habitats.
- Limit aerial applications to once per season.
- A statement advising that the use of mancozeb may result in leaching of ETU to groundwater particularly in areas where soils are permeable and/or the depth to the water table is shallow.
Canada is a member of the Organisation for Economic Cooperation and Development (OECD), which provides a forum for governments to work together to share experiences and seek solutions to common problems. As stated above, the following pertains to the registration status of maconzeb at the time PRVD2013-01 was originally issued.
Mancozeb is registered for use in the European Union and the United States. The European Union published a final review report for mancozeb in July 2009. The European Union concluded that the use of mancozeb on apple, potato, tomato and grape was acceptable based on available information at that time. The European Union requested additional confirmatory data. In the United States, mancozeb is registered for use on similar agricultural crops as in Canada, on turf, ornamentals and, seed and potato seed piece treatments. The American rates are lower than those in Canada and preharvest intervals are longer for many crops (apple, pear, grapes and potato). The United States Enviromental Protection Agency (USEPA) published a re-registration eligibility decision for mancozeb in September 2005. The USEPA concluded that re-registration of mancozeb was acceptable provided that additional risk mitigation measures were implemented. In addition, the USEPA requested additional confirmatory data.
The public, including manufacturers and stakeholders, are encouraged to submit comments during the 90-day public consultation period. Please forward all comments to PMRA Publications. If additional scientific data and/or changes to the use pattern are not adequate to address the risks identified above, all uses of mancozeb, except greenhouse tobacco, will be cancelled.
All comments received during the public consultation period will be taken into consideration in preparation of the re-evaluation decision document. The re-evaluation decision document will include the final re-evaluation decision, the reasons for it and a summary of comments received on the proposed re-evaluation decision with the PMRA’s responses.
The implementation timeline for the cancellation or amendments to product labels will be determined at the final decision phase of this re-evaluation, taking into consideration the PMRA’s cancellation and amendments policy (Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following a Re-evaluation and Special Review).
No additional scientific data are required at this time. However, during the consultation period, the registrants may consider submission of further data or propose changes to the use pattern that could be used to address the human health and environmental risks identified. These data are identified in Section 8.2 of PRVD2018-17.
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