Addendum II: Terms and conditions for confined research field trials of Camelina (Camelina sativa (L.) Crantz) expressing industrial or pharmaceutical compounds

Any release of a plant with a novel trait 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.

Transportation

1. Seed and plant material that is to be planted, any excess from transplantation, and that from harvesting must be transported in clearly labelled and secure containers that are to be kept separate from other seed and plant material. These requirements also apply to all non-modified plant material from the trial site.

Reproductive isolation

2. Camelina sativa plants in the trial must be reproductively isolated from Camelina species by: (a) a minimum 20 metre isolation distance; or (b) growth in cages or bags. Should isolation method (b) fail, a 20 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 40 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). During the year of the trial, all listed Camelina species found on the trial site (apart from plants in the trial) and all listed species in the isolation distance must be removed before seed set. During the three post-harvest growing seasons, all listed Camelina species must be removed from the trial site before flowering.

3. Trial plants must be reproductively isolated from other related species by a minimum of 20 metres surrounding the trial site (including ditches, shelterbelts and neighbouring land), unless other methods of reproductive isolation are being used (e.g. cages or bags) without failure. The related species include: 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 (yellow ball mustard), Turritis glabra (tower cress, tower mustard). During the year of the trial, all listed related species found on the trial site and within 20 metres of the trial site must be removed before seed set. During the post-harvest growing seasons, these related species must also be removed from the trial site before flowering.

4. In the first post-harvest year, 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.

5. 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 three 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 three consecutive years following termination of the trial.

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 material from the trial.

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 research field trial boundaries. The markers (e.g. flags, corner posts, etc.) should be obvious, identifiable above the maximum height of the surrounding crop and in place for the growing seasons of both the trial and the post-harvest restriction period.

8. Distance measurements from visible and accessible permanent surrounding landmarks must be provided for precise location of the trial 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").

Disposal

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, 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.

Storage

13. All retained seed and plant material, including the excess from planting and harvesting, must be stored appropriately in clearly labelled and secure containers. These containers must be 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.

Monitoring

14. During the trial growing season, the trial site and isolation distance must be monitored weekly to ensure that all related species are removed before seed set.

15. During the post-harvest growing seasons, the trial site and a 10 metre zone around the trial (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.

Accidental release

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).

Records

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 are found in section 3.7 of Directive 2000-07.

Information provided to the PBO

18. a) Applicants must provide the following information to the PBO in writing within 15 working days after harvest:

• confirmation of whether or not seed and plant material was harvested and quantity^Footnote 1 of seed and plant material harvested at the trial sites
• final date of harvest
• confirmation of whether or not seed and plant material has been disposed of and quantity of seed and plant material disposed of
• location, method and date of disposal^Footnote 2
• confirmation of whether or not seed and plant material has been retained and 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.

19. 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 1. During the post-harvest years, the PBO may impose additional restrictions on cultivation of crops intended for food or feed use, or on grazing of livestock. These restrictions will be imposed on a case-by-case basis. Applicants are encouraged to consult with the PBO to ensure appropriate planning for post-harvest land use.

Other

20. It is not permitted to allow livestock on trial sites, including during the post-harvest period.

21. 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.