Re-evaluation Note REV2017-06, Re-evaluation Project Plan for Cyprodinil

Pest Management Regulatory Agency
10 March 2017
ISSN: 1925-0649 (PDF version)
Catalogue number: H113-5/2017-6E-PDF (PDF version)

Table of Contents

Background

In Canada, cyprodinil is under re-evaluation by Health Canada’s Pest Management Regulatory Agency (PMRA). The PMRA re-evaluates registered pesticides to determine whether the use of these products continues to be acceptable in terms of value, human health and the environment according to current standards.

Cyprodinil is a fungicide registered for use on a variety of terrestrial food/feed and non-food/non-feed crops, greenhouse food crops and outdoor ornamentals. As of 6 January 2017, there are one technical and seven commercial class end-use products containing cyprodinil registered in Canada.

Under the authority of section 16 of the Pest Control Products Act, the registrant of cyprodinil was notified of the initiation of the re-evaluation of cyprodinil. Following this, the registrant of cyprodinil technical grade active ingredient indicated support of all uses included on the labels of end-use products in Canada.

The re-evaluation project plan outlines the timeline, the anticipated areas of focus for the risk assessments, and the data requirements for the re-evaluation of cyprodinil.

Re-evaluation Project Plan

Anticipated Re-evaluation Timeline

The re-evaluation of cyprodinil is defined as a Category 1 as described in Regulatory Directive DIR2016-04, Management of Pesticides Re-evaluation Policy, which was adopted on 1 December 2016. However, because this re-evaluation was initiated prior to the publication of DIR2016-04, the proposed re-evaluation decision for cyprodinil is anticipated to be published for consultation by June 2019. The re-evaluation timeline may be updated if, during the risk assessment, the PMRA identifies additional areas of focus that should be considered.

Human Health Risk Assessment

New assessments will be conducted for toxicology and dietary exposure. Existing assessments with minor updates are considered to be adequate to support the re-evaluation of cyprodinil for the other aspects of human health assessment.

Environmental Risk Assessment

New assessments will be conducted for environmental fate, water modelling and environmental exposure.

Value

The value of cyprodinil will be considered. The viability of alternatives will be examined for certain uses if risks of concern requiring mitigation are identified.

Data Requirements

The PMRA has identified the need for the technical registrant to provide data for cyprodinil related to toxicology, dietary exposure and the environment. Relevant data/studies have been requested from the technical registrant. A summary of the data call-in is found in the PMRA’s Public Registry, found online at http://www.hc-sc.gc.ca/cps-spc/pest/part/protect-proteger/publi-regist/index-eng.php#ppid. For a list of data categories that have been required, see Appendix I. In addition, information regarding the registered use pattern has been requested from the registrants, to inform the risk assessments.

PMRA documents can be found in the Pesticides and Pest Management section of Health Canada’s website at healthcanada.gc.ca/pmra. PMRA documents are also available through the Pest Management Information Service:

Phone: 1-800-267-6315 within Canada or 1-613-736-3799 outside Canada (long distance charges apply)
Fax:      613-736-3798
E-mail: pmra.infoserv@hc-sc.gc.ca

Appendix I Data Required under Subsection 19(1) of the Pest Control Products Act for the Re-evaluation of Cyprodinil

Toxicology

DACO 4.3.1
Short-term Oral (90-day rodent)
DACO 4.3.5
Short-term Dermal (21/28-day)
DACO 4.5.12
Acute Neurotoxicity (rat)
DACO 4.5.13
90-day Neurotoxicity (rat)
DACO 4.5.15
28-day Immunotoxicity (rodent)

Dietary Exposure

DACO 7.2
Analytical Methodology (Food Crops & Tobacco)
DACO 7.2
Analytical Methodology (Food Crops & Tobacco)
DACO 7.4
Crop Residue Data

Environment

DACO 9.3.4
Laboratory Studies with Other Species
DACO 9.4.5
Chronic (Mollusk or Crustacean)
DACO 9.9
Other Studies/Data/Reports
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