Addendum III: Terms and conditions for confined research field trials of camelina (Camelina sativa (L.) Crantz) expressing industrial or pharmaceutical compounds – Special Case -
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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. Camelina sativa plants in the trial must be reproductively isolated from Camelina species by: (a) a minimum 30 metre isolation distance; or (b) growth in cages or bags. Should the isolation method (b) fail, a 30 metre isolation distance from Camelina species will be required. In addition, trial plants must be reproductively isolated from Camelina seed production fields by a minimum distance of 120 metres. Camelina species include: C. sativa (false flax or gold-of-pleasure), C. alyssum (gold-of-pleasure), C. microcarpa (small-seeded false flax, littlepod false flax) and C. rumelica (graceful false flax). All listed Camelina species must be removed before seed set when found on the trial site and isolation distance, if used, during the year of the trial. These Camelina species must also be removed from the trial site before flowering when found during the post-trial growing seasons.
3. Trial plants must also be reproductively isolated from other related species by a minimum of 30 metres, unless other methods of reproductive isolation have been used (e.g. bags) without failure. The following species within a 30 metre radius of the trial site (including ditches, shelterbelts and neighbouring land) must be removed: Brassica nigra, Brassica hirta (also known as Sinapis alba), Arabidopsis lyrata (rockcress), Capsella bursa-pastoris (shepherd's-purse), Erysimum spp. (wallflower) [E. asperum, E. cheiranthoides, E. coarctatum, E. hieracifolium, E. inconspicuum, E. pallasii], Neslia paniculata (ball mustard), Turritis glabra (tower cress, tower mustard). All listed related species must be removed before seed set when found on the trial site during the year of the trial. These related species must also be removed from the trial site before flowering when found during the post-trial growing seasons.
4. The trial site and a minimum 10 metre zone (50 metres if commercial-scale equipment was used during harvest) around the trial site, must not be seeded to Camelina species for a minimum of two years following harvest of the trial (please see section "Information to be Provided to the PBO (Plant Biosafety Office)"). The post-harvest restriction period will end once no flowering volunteers of Camelina or related species are observed for two consecutive years following termination of the trial. The PBO may impose restrictions on cultivation of crops for food or feed use or on grazing of livestock during post-harvest years of sites of trials of PNTs intended for plant molecular farming. These restrictions will be imposed on a case-by-case basis. Developers are encouraged to consult with the PBO to ensure appropriate planning for post-harvest land use.
5. In addition to the requirements under conditions 2 and 3, in the first year following harvest, the trial site and a minimum 10 metre zone (50 metres if commercial-scale equipment was used during harvest) must be treated with herbicide sufficient to control any Camelina volunteers prior to flowering.
Cleaning of Equipment
6. 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
7. 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.
8. 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
9. 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 must be harvested unless otherwise approved by the PBO (please see section "Information to be Provided to the PBO").
10. 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.
11. All non-propagable plant material remaining on the trial site must 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. Disposal of plant residue after final harvest must be witnessed by a CFIA inspector.
12. If a trial is terminated prior to harvest, all plant material must be disposed of as described earlier in this section.
13. 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.
14. During the trial growing season, the trial site and isolation distance, if used, must be monitored weekly to ensure that all related species are removed before seed set.
15. During the post-trial growing seasons, the trial site and the 10 metre zone (50 metres if commercial-scale equipment 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 and related species are removed before flowering.
16. 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).
17. 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)
18. In the event of any accidental release of regulated material into the environment, the PBO must be notified immediately.
19. 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 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.
20. 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.
21. 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.
22. No food or feed production including livestock grazing is permitted within 50 metres of the trial during the growing season of the trial.
23. If harvested material is intended for processing, applicants must provide an acceptable processing plan to the PBO at least 60 days prior to processing. No processing is to occur without the written permission of an officer of the PBO.
24. 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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