Frequently Asked Questions
Questions
Answers
How does this new database relate to the 914 Technology Gap list and the Minor Use Priority Setting List?
Both of these lists were incorporated into the database to be used as a starting place for the database (2008 914 list and minor use priorities list). In addition, grower identified priorities from the AAFC/Health Canada Pesticide Risk Reduction program and the NAFTA Commodity-based projects were added to the database.
How will this list be used to take steps to address technology gaps?
Health Canada will use this list in a number of ways:
- For the 914 Technology Gap Program:
- Health Canada will use the database to help chose potential candidates for the 914 Technology Gap Program
- In Re-evaluation:
- Health Canada and EPA will use the database to identify MRL differences that could be looked at when an active ingredient goes under re-evaluation
- For New Submission:
- Health Canada may use the database to identify to registrants other uses that are needed so they could consider adding them to the label for new submissions (for example, during a presubmission consultation with a registrant)
- Health Canada could work with registrants and other stakeholders to try and obtain required data to support these additional uses if it is not readily available to the registrant (for example, to obtain efficacy data)
What are the criteria to determine how active ingredients will be prioritized by growers?
Examples:
- active ingredient is critical to crop production with limited to no alternatives
- active ingredient is not yet registered in Canada
- active ingredient is registered in Canada but not on the same crops or pests that are registered in the US
- active ingredient is needed for resistance management purposes
- active ingredient is identified as necessary to control a pest new to Canada
- active ingredient is identified as a reduced risk, low risk pesticide or a biopesticide
- active ingredient is identified as a solution on the national minor use priority-setting list
- active ingredient is more efficient than current market products
- use is identified as a need in a transition strategy to address the loss of a use through re-evaluation
- active ingredient is more efficient than current market product
- product is being/has been developed for minor use additions by IR-4
- registrant is willing to submit for registration in Canada (under certain circumstances)
- there is a desire for 'Import MRLs' here, to support uses already on the US or other foreign labels
- there may be some other registered products or uses, but they may be lost for future use (e.g. through re-evaluation or registrant cancellation)
- there are a number of uses/crops on the US label of interest to Canadian growers
- there are no known impediments to submission in Canada
- the US data package in support of the active ingredient is sufficiently modern to answer most or all the concerns for Canadian registration
How will this affect work prioritization at Health Canada?
Health Canada will consider these priorities under the existing 914 Technology Gap Program. Other submissions will continue to be worked on as provided for in the Health Canada's Management of Submissions Policy (MOSP)
How were the representatives selected for the Database Screening Committee?
At the Grower Priority Database Stakeholder meeting held via teleconference December 16, 2008 Health Canada asked for volunteers and nominees to represent each crop grouping. Some names of nominees and volunteers were obtained at the meeting, while others were emailed in following the meeting.
Who are the representatives on the Database Screening Committee?
There is one representative and at least one alternate from each commodity grouping and from Registrants PMUCs, AAFC, and Health Canada. Commodity Groupings include:
- Berry Crops
- Tree Fruits
- Vegetables
- Potato
- Cereal Crops
- Oilseeds
- Pulse and Specialty Crops
- Herbs and Spices
- Ornamentals
- Honey Bees
- Mushroom
- Forage and Feed Crops
- Greenhouse Food Crops
- Organic Crops
- Soybean
- Hemp
How were crop groupings selected?
Originally Health Canada used CFIA's crop grouping scheme which was presented at the Stakeholder Meeting on Dec 16, 2008. Comments from stakeholders at that meeting resulted in the crop grouping scheme now being used.
Is the role of the database Screening Committee to motivate registrants to bring new products to Canada if an MRL exists elsewhere?
No. The role of the Database Screening Committee is to oversee the validation and prioritization of the database. In other words, to get growers to prioritize their needs. Once the grower needs are prioritized and entered into the database, registrants can use the database to identify grower needs and potential markets for new or existing active ingredients.
Why are forestry and other use sectors not included in the database?
The NAFTA Project was originally based on food agriculture as U.S. growers are concerned about MRL differences. Hence other sectors are not reflected in the current online database. The Canadian database does include ornamentals and we hope to include other use sectors in the future.
How often will the database be updated and who will be responsible for this?
The database will be updated on a yearly basis. The process for updating the database hasn't been determined yet. Health Canada will update the regulatory portions of the database.
How will the identification of U.S. grower's import tolerance needs benefit Canadian growers?
U.S. registrants will be able to identify Canadian grower needs that are for the same product/ crop/use combination as the U.S. import tolerance and can consider Canadian registration to deal with the issue rather than just applying for an import tolerance. Regulatory Agencies may also identify these related needs to the registrants.