Proposal for a User Requested Minor Use Label Expansion

Privacy Notice Statement

Health Canada
Collection and use of personal information in this application is in accordance with the federal Privacy Act.

The personal information you provide is collected under the authority of section 6(1)(a) of the Pest Control Product Regulations for the purpose of contacting the applicant in regards to the application and to communicate any decisions and outcomes of the application

The Privacy Act gives you the rights of access to, correction of and protection of your personal information. For further information about this Privacy statement please contact Health Canada’s Access to Information and Privacy Coordinator by email at atip-aiprp@hc-sc.gc.ca.

Instructions

The completed form, in addition to a cover letter, a letter of support from the registrant of the proposed pest control product and a proposed supplemental label, must be included in the package submitted to the Agency for consideration. The proposed use(s) must be described in detail and it is essential that the use pattern is consistently presented in all submitted documentation. If there is insufficient space in any field, provide information that cannot be incorporated into the form in the accompanying cover letter.

Data requirements necessary for the registration of the proposed new use are assessed on the basis of the information provided on this form; therefore, complete and accurate information is critical to the success of any URMULE proposal. As a prerequisite step, submitters are advised to obtain and read the registered Canadian product label carefully.

Form terminology reflects crop uses as these account for the majority of the proposals; however, appropriate terms / units can be substituted, where required, to support minor use proposals in other use areas.

Specific Field Instructions:

Instruction 1

Registrant Name and Address

This is the current or intended registrant of the product. The name must be a legal entity (trademark names are not acceptable). Note that the PMRA reserves the right to ask for the legal documentation proving the legal existence of the intended or current registrant.

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Instruction 2

Sponsor

Identify sponsor, affiliation, address and contact information.

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Instruction 3

Submitted by

Identify the submitter of the proposal.

Proposals not received from the Agriculture and Agri-Food Canada Pest Management Centre (AAFC-PMC) must be submitted by a Forestry or Provincial Minor Use Coordinator (F/P MUC). Proposals for minor use label expansions received from other sources are not accepted by the Agency.

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Instruction 4

Pesticide

Provide the information requested on the form.

Enter the complete product name as found on the product label (e.g. XYZ 300 Systemic Flowable Insecticide rather than simply XYZ). Enter the formulation type where identified on the product label.

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Instruction 5

Crops and Scope of Proposed Use
Complete either Field 5a) or 5b) depending upon whether the proposal represents a use expansion for a specific crop or for a crop group/subgroup.

Be specific when describing the proposed use (e.g. alfalfa grown for seed production only; orchard crops may be described as newly established/non bearing, established/non bearing or bearing trees).

Requesting Specific Crop [5a)]:
Include only one crop per proposal unless requesting a crop group or subgroup under Field 4b). If the crop is not listed in Section 15 of the Residue Chemistry Guidelines (DIR98-02), provide a detailed description of its growth characteristics, biological name and identify the part(s) of the crop consumed for food/feed/forage in the cover letter.

Indicate the typical number of days between transplanting/planting and harvest for the proposed crop. If the use is for a perennial crop, indicate the time between planting and first harvest.

Requesting Crop Group or Crop Subgroup [5b)]:
Consult Section 15 of DIR98-02 for a complete description of crop groups.

Identify the crop group or sub-group to which the URMULE applies. For example:

Requesting Crop Group
X Identify Brassica vegetables, CG #5

Requesting Crop Subgroup
X Identify Caneberries, CG #13-A

Scope of Proposed Use
Identify whether the proposal is requesting national or regional registration. If regional, specify the corresponding province(s) or region.

Indicate the total area, in hectares, to be planted corresponding to the scope of the proposed use expansion (i.e. if a regional request, do not provide the national area) for the crop listed in Field 4a) or for the group/subgroup identified in Field 4b) and the potential area to be treated as a percentage of this value if registration is accepted.

For specific crop proposals, identify the acreage grown, percent to be treated and zonal breakdown for any crop for which residue trial requirements are not prescribed in Section 9 of DIR98-02. Include copies of all documentation (e.g. e-mail or other correspondence, website data) providing acreage information in support of the identified zonal breakdown. See Section 9 of DIR98-02 for a description of Canadian crop zones.

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Instruction 6

Pest(s)

Identify the proposed target pest(s) by common and scientific names rather than broad descriptions such as leafrollers, grassy/broadleaf weeds, fungi; for example, “Western Cherry Fruit Fly [Rhagoletis indifferens (Curran)]”. Refer to the registered product label for guidance. If control of more than one pest is being sought and the use pattern differs (rates, timing, ...), a single proposal is sufficient if the submitted supporting documentation clearly identifies the use pattern specific to each pest.

Describe the nature of the pest problem
Provide information concerning the pest(s), such as the following:

  1. Is it a national/regional pest?
  2. Is control of the pest critical or is it only an incidental/occasional problem?
  3. What level of control is being sought (e.g. reduction, suppression or control)?
  4. Does pest pressure vary from year to year; if so, describe the extent of variation. Has this variation been accounted for in the proposed use pattern?
  5. What is the nature and extent of crop damage caused by the pest?

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Instruction 7

Proposed Directions for Use

Application Rate
Express the rate both in terms of product and active ingredient per hectare (e.g. g a.i./ha). Indicate if the application is for crop area or soil surface area.

The proposed rate(s) must be supported by data. If a range of application rates is proposed, instructions or parameters must clearly identify when each rate is to be used (e.g. weed density, level of control).

Number of Applications / Interval Between Applications
Identify the maximum number of applications and the corresponding interval between applications. Identify whether the requested number of applications apply per crop or per year (e.g. multiple crops may be grown annually in a greenhouse).

Timing of Application(s)
Identify crop growth stage and/or pest growth stage, as appropriate, and ensure that it is clear as to whether the stated timing applies to the crop or the pest growth stage (e.g. preemergent to crop or to weed). Include any other relevant guidance with respect to timing of application.

Use of Adjuvant / Surfactant
Indicate whether or not an adjuvant/surfactant is to be used in conjunction with this use expansion. If so, identify the adjuvant/surfactant and provide its Pest Control Product (PCP) Registration Number and the proposed application rate (e.g. % volume/volume).

Volume of Spray/ha
Water volumes may vary due to changing plant sizes, as in the case of immature vs mature trees in an orchard or when the canopy reaches maximum development. The water volume should accurately reflect the common application practices in use for each crop. Refer to the product label if approximate water volumes are to be used. For example, it is common to use phrases such as “use up to 500 L per hectare”, “use enough water to thoroughly cover the target”, “apply to runoff” or “drench the root area to a depth of 8 cm”. Be as specific as possible.

Method of Application
For example, seed treatment, pre-plant incorporated (ppi), pre/post-emergent, foliar, drench, aerial, banded, broadcast.

Preharvest Interval (days)
This value represents the minimum period of time, in days, that must elapse between the last application of the product and harvesting of plants, grazing (sometimes called the pregrazing interval) or cutting for livestock food.

Type of Equipment
For example, wipe-on, fogger, hand gun, air-blast sprayer, seeder. Also indicate whether the application is a directed spray or if specialized equipment is to be used such as a hooded sprayer.

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Instruction 8

Efficacy and Crop Tolerance Data

Efficacy and crop tolerance data requirements are outlined in Section 4 of Regulatory Directive, User Requested Minor Use Label Expansion (DIR2001-01). If including data, submit raw data rather than data summaries, and provide copies of any cited abstracts or published articles. If applicable, reference the corresponding submission number(s) of any data previously submitted to the Agency that may be relevant in supporting the proposed use expansion. Available submitted or referenced data will be considered in establishing further value requirements. See the Efficacy Guidelines for Plant Protection Products (DIR2003-04) for further guidance in data generation and reporting.

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Instruction 9

Residue Data

Residue data requirements for food and feed uses are outlined in Section 4 of Regulatory Directive, User Requested Minor Use Label Expansion (DIR2001-01). If applicable, reference the corresponding submission number(s) of any data previously submitted to the Agency that may be relevant in supporting the proposed use expansion. Available submitted or referenced data will be considered in establishing further residue requirements. See the Residue Chemistry Guidelines (DIR98-02) for further guidance in data generation and reporting.

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Instruction 10

Other Registered Pesticides in Canada

List all products currently registered for this pest/crop combination. This information may be obtained from Provincial Crop Recommendation Guides or via a label search on the PMRA website.

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Instruction 11

Justification of Proposal In Light of Registered Alternatives

State why the use is required in consideration of the alternatives listed in Field 9 of the form. For example, currently registered pesticides may be more expensive, not available in the marketplace, do not fit into an Integrated Pest Management (IPM) program, harmful to beneficials, have a limited spectrum of activity, have questionable long-term regulatory viability and/or do not fit into resistence management schemes.

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Instruction 12

Reduced-risk Status

Minor use presubmission consultation proposals that qualify as reduced-risk chemicals or biopesticides benefit from an expedited review (five month review timeline versus six months) when the complete submission is subsequently received by the Agency for full review and a decision on acceptability for registration. If appropriate, specify how this use meets the criteria for reduced risk status. See The PMRA Initiative for Reduced-Risk Pesticides (DIR2002-02) for further guidance on applying for reduced-risk status. Details are provided in Sections 4.0 to 5.0 for chemical pesticides and in Section 7.0 for biopesticides.

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Instruction 13

Use Registration in the United States

Identify whether the specific pest/crop combination is registered in the United States (U.S.) and, if so, provide a copy of the label or guarantee/rate information if the U.S. label is not available.

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Form

1. Registrant Name and Address Instruction 1
2. Sponsor Instruction 2
3. Submitted by Instruction 3
4. Pesticide Instruction 4
5. Crops (complete either 5a or 5b) and scope of proposed use Instruction 5
a) Requesting Specific Crop
b) Requesting crop group OR Crop Subgroup (required)


SCOPE OF PROPOSED USE (required)
OR
Cultivated area distribution (in ha) for a specific crop not listed in the Residue Chemistry Guidelines (DIR98-02)
6. Pest(s) Instruction 6
7. Proposed Directions for Use Instruction 7

   OR   
Use of Adjuvant/Surfactant (required)       

Instruction 8
10. Other Registered Pesticides in Canada Instruction 10
Are other pesticides registered in Canada for this use? (required)       
If yes, list below
Registration Number Product Name
 
Instruction 11
12. Reduced-risk Status Instruction 12

13. Use Registration in the United States Instruction 13
Is this use registered in the U.S.? If yes, provide U.S. label (required)    
If the U.S. label is not available, please provide:

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