Terms and conditions for confined research field trials of opium poppy (Papaver somniferum) expressing industrial or pharmaceutical compounds

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 at the Canadian Food Inspection Agency (CFIA), is a contravention of Part V of the Seeds Regulations. Failure of the applicant to comply with conditions of an authorized release is a contravention of Part V of the Seeds Regulations.

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Transportation

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

P. Somniferum plants in the trial must be reproductively isolated from Papaver species by a minimum 20 metre isolation distance or cages or bags. Should the cages or bags fail, a 20 metre isolation distance from Papaver species will be required.

Papaver species include:

  • P. kluanense (alpine poppy)
  • P. pygmaeum (alpine glacier poppy or dwarf alpine poppy)

During the year of the trial, all listed Papaver species found on the trial site and in the isolation distance must be removed before seed set.

During the 3 post-harvest growing seasons, all listed Papaver species must be removed from the trial site before flowering.

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 seeded to Papaver species for 3 years following harvest of the trial unless otherwise granted by the Plant Biosafety Office.

Consult Information to be provided to the Plant Biosafety Office for more information.

Cleaning of equipment

Machinery and equipment used for seeding, transplanting, site maintenance and harvesting must be cleaned of all seed and 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

Markers should be placed at all corners of the trial site to identify the confined research field trial boundaries. The markers (for example: 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 post-harvest restriction period.

Distance measurements from visible and accessible permanent surrounding landmarks must be provided for precise location of the trial site. GPS coordinates must be taken precisely at all corners of each trial site in the latitude longitude decimal degree format (for example, "50.12345, -110.12345"). The GPS coordinates of each confined research field trial site location must be submitted to the Plant Biosafety Office within 7 days after planting.

Monitoring

During the trial growing season, the trial site and the surrounding 20 metre isolation distance must be monitored weekly to ensure that all related species are removed before seed set.

During the 3 post-harvest growing seasons the trial site and the 10 metre zone (50 metre if a commercial-scale combine was used during harvest), must be monitored at least once every 2 weeks to ensure that all volunteer plants and related species are removed before flowering.

See the section Reproductive isolation for more information.

Harvesting and seed set

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 Plant Biosafety Office. Consult Information to be provided to the Plant Biosafety Office for more information.

It is strongly encouraged that plants be harvested before full maturity to minimize shattering and seed dispersal.

Disposal

The following plant material that is not to be retained must be disposed of by crushing, burning to ash, autoclaving or burial at a depth of one metre: surplus seed or seedlings, plant material remaining after planting or transplantation and propagable plant material harvested from the trial site. 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 propagable plant material must be devitalized. Composting of this material is not an acceptable destruction method. These requirements apply to all modified and non-modified plant material on the trial site.

All non-propagable plant material remaining on the trial site must be either soil incorporated or destroyed 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.

If a trial is terminated prior to harvest, all plant material must be disposed of as described in this section.

Information to provide to the Plant Biosafety Office

15 days after harvest

Provide the following information to the Plant Biosafety Office in writing within 15 working days after harvest:

  • Confirmation of whether or not seed and plant material was harvested and quantityFootnote 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 disposalFootnote 2
  • If disposal occurs at a location other than the trial site, a detailed and complete map of the disposal site location(s) and detailed directions to the site(s)
  • 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

15 days before destruction

If a trial is terminated prior to harvest, provide information on the trial's growth stage at the time of destruction, as well as the date and method of destruction, to the Plant Biosafety Office in writing within 15 working days.

Annual list of planted crop species planted by June 1st

Notify the Plant Biosafety Office in writing every year by June 1st of the crop species planted on trial sites for each year the sites are subject to post-harvest land use restrictions.

Storage

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 Plant Biosafety Office must be immediately notified.

Accidental release

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 Plant Biosafety Office notified immediately. Plants from unrecoverable seed must be immediately destroyed (this can include mechanical or chemical means).

Records

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.

Consult the requirements for records and reporting of confined research field trials (section 3.7 of Directive 2000-07) for more information.

Other

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

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.

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.