Addendum II: Terms and conditions for confined research field trials of alfalfa (Medicago sativa L.)
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Any release of a plant with a novel trait (PNT) into the environment in the absence of explicit authorization by the Director of the Plant Production Division, CFIA, is a contravention of Part V of the Seeds Regulations. Failure to comply with conditions of an authorized release is a contravention of Part V of the Seeds Regulations.
1. The applicant must ensure that all trial seed and plant material, including seed and plant material to be planted, excess from transplantation and harvested seed and plant material, are transported in clearly identified, secure containers and are kept separate from other seed and plant material. These requirements also apply to all non-modified plant material on the trial site.
2. Alfalfa plants in the trial must be reproductively isolated from other alfalfa plants, including feral populations, by a minimum distance of 300 metres. All alfalfa plants must be removed before seed set from the isolation distance during the year of the trial.
3. The trial site and a minimum 10 metre zone (50 metres if a commercial-scale combine was used during harvest) around the trial site, must not be used to grow alfalfa for three years after the trial is completed. All volunteers must be removed from the trial site before flowering when found during the post-trial growing seasons (Please see section "Information to be provided to the PBO (Plant Biosafety Office)").
Cleaning of Equipment
4. Seeding, transplanting, site maintenance and harvesting machinery and equipment must be cleaned of all residual plant material at the trial site prior to being moved to other locations to prevent dispersal of novel plant material.
Trial Boundary Marking
5. The use of markers is strongly recommended. Markers should be placed at all corners of the trial site to identify the confined field trial boundaries. The markers (e.g. flags, corner posts, etc.) should be obvious, identifiable and in place for the growing seasons of both the trial and the post-harvest restriction period.
6. Distance measurements from permanent surrounding landmarks must be provided for precise location of the site. Global Positioning System (GPS) coordinates must be taken precisely at all corners of each trial site. The GPS coordinates of each confined research field trial site location must be submitted to the PBO within seven (7) days after planting.
Harvesting and Seed Set
7. Plants must be harvested before full maturity to minimize shattering and seed dispersal. If seed set occurs, all seed and other propagable plant material from the confined research field trial, including non-modified control material, must be harvested unless otherwise approved by the PBO (Please see section "Information to be provided to the PBO (Plant Biosafety Office)").
8. Surplus seed or seedlings, any plant material remaining after planting or transplantation that is to be destroyed, and all propagable plant material harvested from the confined research field trial that is not to be retained, must be disposed of by crushing, burning, autoclaving or burial at a depth of one metre. When crushing is used to dispose of the seed, the crushed seed must be soil incorporated within 48 hours after harvest and the mechanical rollers must be thoroughly cleaned at the trial site. Regardless of destruction method, all seed must be devitalized. Composting of this material is not an acceptable destruction method. These requirements also apply to all non-modified plant material on the trial site.
9. At the termination of the trial, the trial site must be sprayed with a non selective herbicide to destroy plants remaining in the field. All non-propagable plant material remaining on the trial site must then be either soil-incorporated or destroyed by incineration as soon as possible after harvest. Applicants are encouraged to destroy all non-propagable plant material in a manner whereby the material is not easily distributed by wind or local fauna, yet does not promote seed dormancy. If the applicant decides to burn the plant material, the material must be burned to ash.
10. If a trial is terminated prior to harvest, applicants must provide information on the trial's growth stage at the time of destruction, as well as the date and method of destruction, to the PBO in writing within 15 working days.
11. All seed and plant material including excess from planting and harvested seed and plant material, that is retained must be stored appropriately in clearly labelled and secure containers and kept separate from other seed and plant material. These requirements also apply to non-modified seed and plant material harvested from trial sites. A secure container must be designed to minimize the potential for a spill or dissemination. Each container must be labelled "PNT material – Do not mix". In the event of any accidental spill or dissemination of material, the PBO must be immediately notified.
12. During the trial growing season, the isolation distance must be monitored weekly to ensure that all alfalfa plants are removed before seed set.
13. During the three post-trial growing seasons, the trial site and the 10 metre zone (50 metre if a commercial-scale combine was used during harvest) is subject to monitoring (Please see section "Reproductive Isolation"). Site monitoring must occur at least once every two weeks to ensure that all volunteer plants are removed before flowering.
14. In the case of accidental release of propagable material in the environment, recoverable seeds or seedlings must be collected and destroyed, the site must be marked and monitored, and the PBO notified immediately. Plants from unrecoverable seed must be immediately destroyed (this can include mechanical or chemical means).
15. A detailed trial log book must be kept. Records of the confined research field trial, including current season and post-harvest site monitoring, activities related to the trial site compliance, cleaning of machinery, transportation, disposition and storage of all surplus seed and harvested seed and plant material, must be maintained by the applicant and made available to the CFIA upon request. A report summarizing the completed trial and experimental data, including any amendments to the original protocol, must also be made available to the CFIA upon request. Detailed records requirements can be found in section 3.7 of Directive 2000-07.
Information to be provided to the PBO (Plant Biosafety Office)
16. In the event of any accidental release of regulated material into the environment, the PBO must be immediately notified.
17. a) Applicants must provide the following information to the PBO in writing within 15 working days after harvest:
- quantity of seed and plant material harvested at the trial sites
- final date of harvest
- quantity of seed and plant material disposed of
- location, method and date of disposalFootnote 1
- quantity of seed and plant material retained and stored
- storage location and method
b) If a trial is destroyed prior to harvest, applicants must provide information on the trial's growth stage at the time of destruction, as well as the date and method of destruction, to the PBO in writing within 15 working days.
18. Applicants must notify the PBO in writing of the crop species planted on field trial sites for each year the sites are subject to post-harvest land use restrictions. This notification must be received every year by June 15.
19. The trial term will be limited to 1 year from the date of authorization, with possibility of renewal.
20. It is not permitted to allow livestock access to sites under post-harvest restrictions. No plant material from these trials may enter the human food or livestock feed chain unless approved by Health Canada or the Animal Feed Division, CFIA, respectively.
21. If a chemical treatment is used on the trial site that requires a temporary prohibition on entry into the site, a sign must be posted at the access to the trial indicating the date and time of spraying as well as the time until safe entry. This condition is intended to protect the health and safety of the CFIA inspection staff.
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